US Code

Public Law 119-73 (01/23/2026)

42 U.S.C. § 1395l

Payment of benefits

(a)

Amounts

section 1395mm of this titleExcept as provided in , and subject to the succeeding provisions of this section, there shall be paid from the Federal Supplementary Medical Insurance Trust Fund, in the case of each individual who is covered under the insurance program established by this part and incurs expenses for services with respect to which benefits are payable under this part, amounts equal to—
(1)
section 1395k(a)(1) of this titlesection 1395x(s)(10)(A) of this titlesection 1395y(a)(4) of this titlesection 1395m(d)(1) of this titlesection 1395m–1 of this title1
1 So in original.
section 1395rr of this titlesection 1395x(s)(2)(N) of this titlesection 1395x(s)(11) of this titlesection 1395w–4 of this titlelsection 1395m(a)(13) of this titlesection 1395m(a)(1) of this title2
2 So in original. The word “and” probably should not appear.
section 1395m(b)(6) of this titlesection 1395w–4 of this titlesection 1395m(b) of this titlesection 1395x(s)(2)(L) of this titlesection 1395w–4 of this titlesection 1395x(s)(2)(M) of this titlesection 1395m(h)(4) of this titlesection 1395m(h)(1) of this titlesection 1395w–4(j)(3) of this titlesection 1395x(hhh)(1) of this titlesection 1395w–4(a)(1) of this titlesection 1395x(s)(2)(K) of this titlesection 1395w–4 of this titlesection 1395m(i) of this titlesection 1395u(s) of this titlellsection 1395m(g) of this titlesection 1395x(zz) of this titleosection 1395x(n) of this titlesection 1395w–3a of this titlesection 1395w–3b of this titlesection 1395x(vv) of this titlesection 1395w–4(b) of this titlesection 1395m(m)(2)(B) of this titlesection 1395w–3(a)(2) of this titlesection 1395w–3(b)(5) of this titlesection 1395x(ddd)(1) of this titlesection 1395x(hhh)(1) of this titlesection 1395w–4 of this titlesection 1395x(ddd)(3) of this titleosection 1395m(s) of this titlesection 1395m(u) of this titlesection 1395m(w) of this titlesection 1395w–3a(i) of this titlesection 1320f–1(c) of this titlesection 1395w–3a(b)(1)(B) of this titlesection 1395w–3a(b)(1)(B) of this titlesection 1395w–3a(i)(5)(B) of this title3
3 So in original. Probably should be followed by a comma.
section 1395x(s)(2)(II) of this titlesection 1395x(mmm) of this titlesection 1395m(z) of this titlesection 1395x(zz) of this titleo in the case of services described in —80 percent of the reasonable charges for the services; except that (A) an organization which provides medical and other health services (or arranges for their availability) on a prepayment basis (and either is sponsored by a union or employer, or does not provide, or arrange for the provision of, any inpatient hospital services) may elect to be paid 80 percent of the reasonable cost of services for which payment may be made under this part on behalf of individuals enrolled in such organization in lieu of 80 percent of the reasonable charges for such services if the organization undertakes to charge such individuals no more than 20 percent of such reasonable cost plus any amounts payable by them as a result of subsection (b), (B) with respect to items and services described in , the amounts paid shall be 100 percent of the reasonable charges for such items and services, (C) with respect to expenses incurred for those physicians’ services for which payment may be made under this part that are described in , the amounts paid shall be subject to such limitations as may be prescribed by regulations, (D) with respect to clinical diagnostic laboratory tests for which payment is made under this part (i)(I) on the basis of a fee schedule under subsection (h)(1) (for tests furnished before ) or , the amount paid shall be equal to 80 percent (or 100 percent, in the case of such tests for which payment is made on an assignment-related basis) of the lesser of the amount determined under such fee schedule, the limitation amount for that test determined under subsection (h)(4)(B), or the amount of the charges billed for the tests, or (II) under (for tests furnished on or after ), the amount paid shall be equal to 80 percent (or 100 percent, in the case of such tests for which payment is made on an assignment-related basis) of the lesser of the amount determined under such section or the amount of the charges billed for the tests, or (ii) for tests furnished before , on the basis of a negotiated rate established under subsection (h)(6), the amount paid shall be equal to 100 percent of such negotiated rate,, (E) with respect to services furnished to individuals who have been determined to have end stage renal disease, the amounts paid shall be determined subject to the provisions of , (F) with respect to clinical social worker services under , the amounts paid shall be 80 percent of the lesser of (i) the actual charge for the services or (ii) 75 percent of the amount determined for payment of a psychologist under clause (L), (G) with respect to facility services furnished in connection with a surgical procedure specified pursuant to subsection (i)(1)(A) and furnished to an individual in an ambulatory surgical center described in such subsection, for services furnished beginning with the implementation date of a revised payment system for such services in such facilities specified in subsection (i)(2)(D), the amounts paid, subject to subsection (i)(9), shall be 80 percent of the lesser of the actual charge for the services or the amount determined by the Secretary under such revised payment system, (H) with respect to services of a certified registered nurse anesthetist under , the amounts paid shall be 80 percent of the least of the actual charge, the prevailing charge that would be recognized (or, for services furnished on or after , the fee schedule amount provided under ) if the services had been performed by an anesthesiologist, or the fee schedule for such services established by the Secretary in accordance with subsection (), (I) with respect to covered items (described in ), the amounts paid shall be the amounts described in , and  (J) with respect to expenses incurred for radiologist services (as defined in ), subject to , the amounts paid shall be 80 percent of the lesser of the actual charge for the services or the amount provided under the fee schedule established under , (K) with respect to certified nurse-midwife services under , the amounts paid shall be 80 percent of the lesser of the actual charge for the services or the amount determined by a fee schedule established by the Secretary for the purposes of this subparagraph (but in no event shall such fee schedule exceed 65 percent of the prevailing charge that would be allowed for the same service performed by a physician, or, for services furnished on or after , 65 percent (or 100 percent for services furnished on or after ) of the fee schedule amount provided under for the same service performed by a physician), (L) with respect to qualified psychologist services under , the amounts paid shall be 80 percent of the lesser of the actual charge for the services or the amount determined by a fee schedule established by the Secretary for the purposes of this subparagraph, (M) with respect to prosthetic devices and orthotics and prosthetics (as defined in ), the amounts paid shall be the amounts described in , (N) with respect to expenses incurred for physicians’ services (as defined in ) other than personalized prevention plan services (as defined in ), the amounts paid shall be 80 percent of the payment basis determined under , (O) with respect to services described in (relating to services furnished by physician assistants, nurse practitioners, or clinic nurse specialists), the amounts paid shall be equal to 80 percent of (i) the lesser of the actual charge or 85 percent of the fee schedule amount provided under , or (ii) in the case of services as an assistant at surgery, the lesser of the actual charge or 85 percent of the amount that would otherwise be recognized if performed by a physician who is serving as an assistant at surgery, (P) with respect to surgical dressings, the amounts paid shall be the amounts determined under , (Q) with respect to items or services for which fee schedules are established pursuant to , the amounts paid shall be 80 percent of the lesser of the actual charge or the fee schedule established in such section, (R) with respect to ambulance services, (i) the amounts paid shall be 80 percent of the lesser of the actual charge for the services or the amount determined by a fee schedule established by the Secretary under section 1395m() of this title and (ii) with respect to ambulance services described in section 1395m()(8) of this title, the amounts paid shall be the amounts determined under for outpatient critical access hospital services, (S)(i) except as provided in clause (ii), subject to subparagraph (EE), with respect to drugs and biologicals (including intravenous immune globulin (as defined in )) not paid on a cost or prospective payment basis as otherwise provided in this part (other than items and services described in subparagraph (B)), the amounts paid shall be 80 percent of the lesser of the actual charge or the payment amount established in section 1395u() of this title (or, if applicable, under section 1395w–3, 1395w–3a, or 1395w–3b of this title), and (ii) with respect to insulin furnished on or after , through an item of durable medical equipment covered under , the amounts paid shall be, subject to the fourth sentence of this subsection, 80 percent of the payment amount established under (or , if applicable) for such insulin, (T) with respect to medical nutrition therapy services (as defined in ), the amount paid shall be 80 percent (or 100 percent if such services are recommended with a grade of A or B by the United States Preventive Services Task Force for any indication or population and are appropriate for the individual) of the lesser of the actual charge for the services or 85 percent of the amount determined under the fee schedule established under for the same services if furnished by a physician, (U) with respect to facility fees described in , the amounts paid shall be 80 percent of the lesser of the actual charge or the amounts specified in such section, (V) notwithstanding subparagraphs (I) (relating to durable medical equipment), (M) (relating to prosthetic devices and orthotics and prosthetics), and (Q) (relating to 1395u(s) items), with respect to competitively priced items and services (described in ) that are furnished in a competitive area, the amounts paid shall be the amounts described in , (W) with respect to additional preventive services (as defined in ), the amount paid shall be (i) in the case of such services which are clinical diagnostic laboratory tests, the amount determined under subparagraph (D) (if such subparagraph were applied, by substituting “100 percent” for “80 percent”), and (ii) in the case of all other such services, 100 percent of the lesser of the actual charge for the service or the amount determined under a fee schedule established by the Secretary for purposes of this subparagraph, (X) with respect to personalized prevention plan services (as defined in ), the amount paid shall be 100 percent of the lesser of the actual charge for the services or the amount determined under the payment basis determined under , (Y) subject to subsection (dd), with respect to preventive services described in subparagraphs (A) and (B) of that are appropriate for the individual and, in the case of such services described in subparagraph (A), are recommended with a grade of A or B by the United States Preventive Services Task Force for any indication or population, the amount paid shall be 100 percent of (i) except as provided in clause (ii), the lesser of the actual charge for the services or the amount determined under the fee schedule that applies to such services under this part, and (ii) in the case of such services that are covered OPD services (as defined in subsection (t)(1)(B)), the amount determined under subsection (t), (Z) with respect to Federally qualified health center services for which payment is made under section 1395m() of this title, the amounts paid shall be 80 percent of the lesser of the actual charge or the amount determined under such section, (AA) with respect to an applicable disposable device (as defined in paragraph (2) of ) furnished to an individual pursuant to paragraph (1) of such section, the amount paid shall be equal to 80 percent of the lesser of the actual charge or the amount determined under paragraph (3) of such section, (BB) with respect to home infusion therapy, the amount paid shall be an amount equal to 80 percent of the lesser of the actual charge for the services or the amount determined under , (CC) with respect to opioid use disorder treatment services furnished during an episode of care, the amount paid shall be equal to the amount payable under less any copayment required as specified by the Secretary, (DD) with respect to a specified COVID–19 testing-related service described in paragraph (1) of subsection (cc) for which payment may be made under a specified outpatient payment provision described in paragraph (2) of such subsection, the amounts paid shall be 100 percent of the payment amount otherwise recognized under such respective specified outpatient payment provision for such service, (EE) with respect to a part B rebatable drug (as defined in paragraph (2) of ) furnished on or after , for which the payment amount for a calendar quarter under paragraph (3)(A)(ii)(I) of such section (or, in the case of a part B rebatable drug that is a selected drug (as defined in for which, the payment amount described in ) for such drug for such quarter exceeds the inflation-adjusted payment under paragraph (3)(A)(ii)(II) of such section for such quarter, the amounts paid shall be equal to the percent of the payment amount under paragraph (3)(A)(ii)(I) of such section or , as applicable, that equals the difference between (i) 100 percent, and (ii) the percent applied under   (FF) with respect to marriage and family therapist services and mental health counselor services under , the amounts paid shall be 80 percent of the lesser of the actual charge for the services or 75 percent of the amount determined for payment of a psychologist under subparagraph (L), (GG) with respect to lymphedema compression treatment items (as defined in ), the amount paid shall be equal to 80 percent of the lesser of the actual charge or the amount determined under the payment basis determined under , and (HH) with respect to items and services related to the administration of intravenous immune globulin furnished on or after , as described in , the amounts paid shall be the lesser of the 80 percent of the actual charge or the payment amount established under section 1395u()(8) of this title;
(2)
section 1395k(a)(2) of this titlesection 1395rr of this title in the case of services described in (except those services described in subparagraphs (C), (D), (E), (F), (G), (H), and (I) of such section and unless otherwise specified in )—
(A)
section 1395x(kk) of this titlesection 1395fff of this title with respect to home health services (other than a covered osteoporosis drug) (as defined in ), the amount determined under the prospective payment system under ;
(B)
section 1395ww of this titlesection 1395yy(e)(9) of this title with respect to other items and services (except those described in subparagraph (C), (D), or (E) of this paragraph and except as may be provided in or )—
(i)
furnished before , the lesser of—
(I)
section 1395x(v) of this title the reasonable cost of such services, as determined under , or
(II)
the customary charges with respect to such services,
section 1395cc(a)(2)(A) of this title less the amount a provider may charge as described in clause (ii) of , but in no case may the payment for such other services exceed 80 percent of such reasonable cost, or
(ii)
section 1395f(b)(2) of this title if such services are furnished before , by a public provider of services, or by another provider which demonstrates to the satisfaction of the Secretary that a significant portion of its patients are low-income (and requests that payment be made under this clause), free of charge or at nominal charges to the public, 80 percent of the amount determined in accordance with , or
(iii)
if such services are furnished on or after , the amount determined under subsection (t), or
(iv)
section 1395f(b)(3) of this title if (and for so long as) the conditions described in are met, the amounts determined under the reimbursement system described in such section;
(C)
section 1395x(p) of this title with respect to services described in the second sentence of , 80 percent of the reasonable charges for such services;
(D)
section 1395m(d)(1) of this titlesection 1395cc of this titlesection 1395m–1 of this titlesection 1395cc of this title with respect to clinical diagnostic laboratory tests for which payment is made under this part (i)(I) on the basis of a fee schedule determined under subsection (h)(1) (for tests furnished before ) or , the amount paid shall be equal to 80 percent (or 100 percent, in the case of such tests for which payment is made on an assignment-related basis or to a provider having an agreement under ) of the lesser of the amount determined under such fee schedule, the limitation amount for that test determined under subsection (h)(4)(B), or the amount of the charges billed for the tests, or (II) under (for tests furnished on or after ), the amount paid shall be equal to 80 percent (or 100 percent, in the case of such tests for which payment is made on an assignment-related basis or to a provider having an agreement under ) of the lesser of the amount determined under such section or the amount of the charges billed for the tests, or (ii) for tests furnished before , on the basis of a negotiated rate established under subsection (h)(6), the amount paid shall be equal to 100 percent of such negotiated rate for such tests;
(E)
with respect to—
(i)
outpatient hospital radiology services (including diagnostic and therapeutic radiology, nuclear medicine and CAT scan procedures, magnetic resonance imaging, and ultrasound and other imaging services, but excluding screening mammography and, for services furnished on or after , diagnostic mammography), and
(ii)
section 1395x(s)(3) of this title effective for procedures performed on or after , diagnostic procedures (as defined by the Secretary) described in (other than diagnostic x-ray tests and diagnostic laboratory tests),
the amount determined under subsection (n) or, for services or procedures performed on or after , subsection (t);
(F)
section 1395x(kk) of this titlesection 1395x(v) of this title with respect to a covered osteoporosis drug (as defined in ) furnished by a home health agency, 80 percent of the reasonable cost of such service, as determined under ;
(G)
section 1395x(s)(10)(A) of this title with respect to items and services described in , the lesser of—
(i)
section 1395x(v) of this title the reasonable cost of such services, as determined under , or
(ii)
the customary charges with respect to such services; and
(H)
section 1395x(hhh)(1) of this title

4

4 See 2010 Amendment note for subsec. (a)(2)(F) to (H) below.
section 1395f(b)(2) of this titleor, if such services are furnished by a public provider of services, or by another provider which demonstrates to the satisfaction of the Secretary that a significant portion of its patients are low-income (and requests that payment be made under this provision), free of charge or at nominal charges to the public, the amount determined in accordance with ;

with respect to personalized prevention plan services (as defined in ) furnished by an outpatient department of a hospital, the amount determined under paragraph (1)(X),
(3)
section 1395k(a)(2)(D) of this title in the case of services described in —
(A)
section 1395x(v)(1)(A) of this titlesection 1395cc(a)(2)(A) of this titlesection 1395x(s)(10)(A) of this title except as provided in subparagraph (B), the costs which are reasonable and related to the cost of furnishing such services or which are based on such other tests of reasonableness as the Secretary may prescribe in regulations, including those authorized under , less the amount a provider may charge as described in clause (ii) of , but in no case may the payment for such services (other than for items and services described in ) exceed 80 percent of such costs; or
(B)
section 1395k(a)(2)(D) of this titlesection 1395w–23(a)(4) of this title with respect to the services described in clause (ii) of that are furnished to an individual enrolled with a MA plan under part C pursuant to a written agreement described in , the amount (if any) by which—
(i)
o the amount of payment that would have otherwise been provided (I) under subparagraph (A) (calculated as if “100 percent” were substituted for “80 percent” in such subparagraph) for such services if the individual had not been so enrolled, or (II) in the case of such services furnished on or after the implementation date of the prospective payment system under section 1395m() of this title, under such section (calculated as if “100 percent” were substituted for “80 percent” in such section) for such services if the individual had not been so enrolled; exceeds
(ii)
the amount of the payments received under such written agreement for such services (not including any financial incentives provided for in such agreement such as risk pool payments, bonuses, or withholds),
section 1395w–27(e)(3)(B) of this titleless the amount the federally qualified health center may charge as described in ;
(4)
section 1395k(a)(2)(F) of this title in the case of facility services described in , and outpatient hospital facility services furnished in connection with surgical procedures specified by the Secretary pursuant to subsection (i)(1)(A), the applicable amount as determined under paragraph (2) or (3) of subsection (i) or subsection (t);
(5)
section 1395m(a)(13) of this titlesection 1395m(a)(1) of this title in the case of covered items (described in ) the amounts described in ;
(6)
section 1395m(g) of this title in the case of outpatient critical access hospital services, the amounts described in ;
(7)
section 1395m(h)(4) of this titlesection 1395m(h) of this title in the case of prosthetic devices and orthotics and prosthetics (as described in ), the amounts described in ;
(8)
in the case of—
(A)
outpatient physical therapy services, outpatient speech-language pathology services, and outpatient occupational therapy services furnished—
(i)
by a rehabilitation agency, public health agency, clinic, comprehensive outpatient rehabilitation facility, or skilled nursing facility,
(ii)
by a home health agency to an individual who is not homebound, or
(iii)
by another entity under an arrangement with an entity described in clause (i) or (ii); and
(B)
outpatient physical therapy services, outpatient speech-language pathology services, and outpatient occupational therapy services furnished—
(i)
by a hospital to an outpatient or to a hospital inpatient who is entitled to benefits under part A but has exhausted benefits for inpatient hospital services during a spell of illness or is not so entitled to benefits under part A, or
(ii)
by another entity under an arrangement with a hospital described in clause (i),
section 1395m(k) of this titlethe amounts described in ;
(9)
section 1395k(a)(2)(E) of this titlesection 1395m(k) of this title in the case of services described in that are not described in paragraph (8), the amounts described in ; and
(10)
section 1395m(x) of this title with respect to rural emergency hospital services furnished on or after , the amounts determined under .
osection 1395x(n) of this titleParagraph (3)(A) shall not apply to Federally qualified health center services furnished on or after the implementation date of the prospective payment system under section 1395m() of this title. For services furnished on or after , paragraph (1)(Y) shall apply with respect to a colorectal cancer screening test regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or for the removal of tissue or other matter or other procedure that is furnished in connection with, as a result of, and in the same clinical encounter as the screening test. The Secretary shall make such adjustments as may be necessary to the amounts paid as specified under paragraph (1)(S)(ii) for insulin furnished on or after , through an item of durable medical equipment covered under , such that the amount of coinsurance payable by an individual enrolled under this part for a month’s supply of such insulin does not exceed $35.
(b)

Deductible provision

section 1395r(a)(1) of this titlesection 1395x(ddd)(3) of this title1section 1395x(kk) of this titlesection 1395cc of this titlesection 1395x(jj) of this titlesection 1395x(nn) of this titlesection 1395x(bbb) of this titlesection 1395x(pp)(1) of this titlesection 1395x(ww) of this titlesection 1395x(hhh)(1) of this title5

5 So in original. Probably should be followed by “to”.
section 1395x(s)(10)(A) of this titlesection 1395x(n) of this title1section 1395e(a)(2) of this titleBefore applying subsection (a) with respect to expenses incurred by an individual during any calendar year, the total amount of the expenses incurred by such individual during such year (which would, except for this subsection, constitute incurred expenses from which benefits payable under subsection (a) are determinable) shall be reduced by a deductible of $75 for calendar years before 1991, $100 for 1991 through 2004, $110 for 2005, and for a subsequent year the amount of such deductible for the previous year increased by the annual percentage increase in the monthly actuarial rate under ending with such subsequent year (rounded to the nearest $1); except that (1) such total amount shall not include expenses incurred for preventive services described in subparagraph (A) of that are recommended with a grade of A or B by the United States Preventive Services Task Force for any indication or population and are appropriate for the individual., (2) such deductible shall not apply with respect to home health services (other than a covered osteoporosis drug (as defined in )), (3) such deductible shall not apply with respect to clinical diagnostic laboratory tests for which payment is made under this part (A) under subsection (a)(1)(D)(i) or (a)(2)(D)(i) on an assignment-related basis, or to a provider having an agreement under , or (B) for tests furnished before , on the basis of a negotiated rate determined under subsection (h)(6), (4) such deductible shall not apply to Federally qualified health center services, (5) such deductible shall not apply with respect to screening mammography (as described in ), (6) such deductible shall not apply with respect to screening pap smear and screening pelvic exam (as described in ), (7) such deductible shall not apply with respect to ultrasound screening for abdominal aortic aneurysm (as defined in ), (8) such deductible shall not apply with respect to colorectal cancer screening tests (as described in ), (9) such deductible shall not apply with respect to an initial preventive physical examination (as defined in ), (10) such deductible shall not apply with respect to personalized prevention plan services (as defined in ), (11) such deductible shall not apply with respect to any specified COVID–19 testing-related service described in paragraph (1) of subsection (cc) for which payment may be made under a specified outpatient payment provision described in paragraph (2) of such subsection, (12) such deductible shall not apply with respect  a COVID–19 vaccine and its administration described in , and (13) such deductible shall not apply with respect to insulin furnished on or after , through an item of durable medical equipment covered under .. The total amount of the expenses incurred by an individual as determined under the preceding sentence shall, after the reduction specified in such sentence, be further reduced by an amount equal to the expenses incurred for the first three pints of whole blood (or equivalent quantities of packed red blood cells, as defined under regulations) furnished to the individual during the calendar year, except that such deductible for such blood shall in accordance with regulations be appropriately reduced to the extent that there has been a replacement of such blood (or equivalent quantities of packed red blood cells, as so defined); and for such purposes blood (or equivalent quantities of packed red blood cells, as so defined) furnished such individual shall be deemed replaced when the institution or other person furnishing such blood (or such equivalent quantities of packed red blood cells, as so defined) is given one pint of blood for each pint of blood (or equivalent quantities of packed red blood cells, as so defined) furnished such individual with respect to which a deduction is made under this sentence. The deductible under the previous sentence for blood or blood cells furnished an individual in a year shall be reduced to the extent that a deductible has been imposed under to blood or blood cells furnished the individual in the year. Paragraph (1) of the first sentence of this subsection shall apply with respect to a colorectal cancer screening test regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or for the removal of tissue or other matter or other procedure that is furnished in connection with, as a result of, and in the same clinical encounter as the screening test.

(c)

Mental disorders

(1)
Notwithstanding any other provision of this part, with respect to expenses incurred in a calendar year in connection with the treatment of mental, psychoneurotic, and personality disorders of an individual who is not an inpatient of a hospital at the time such expenses are incurred, there shall be considered as incurred expenses for purposes of subsections (a) and (b)—
(A)
for expenses incurred in years prior to 2010, only 62½ percent of such expenses;
(B)
for expenses incurred in 2010 or 2011, only 68¾ percent of such expenses;
(C)
for expenses incurred in 2012, only 75 percent of such expenses;
(D)
for expenses incurred in 2013, only 81¼ percent of such expenses; and
(E)
for expenses incurred in 2014 or any subsequent calendar year, 100 percent of such expenses.
(2)
For purposes of subparagraphs (A) through (D) of paragraph (1), the term “treatment” does not include brief office visits (as defined by the Secretary) for the sole purpose of monitoring or changing drug prescriptions used in the treatment of such disorders or partial hospitalization services or intensive outpatient services that are not directly provided by a physician.
(d)

Nonduplication of payments

section 1395e of this titleNo payment may be made under this part with respect to any services furnished an individual to the extent that such individual is entitled (or would be entitled except for ) to have payment made with respect to such services under part A.

(e)

Information for determination of amounts due

No payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period.

(f)

Maximum rate of payment per visit for independent rural health clinics

(1)
In establishing limits under subsection (a) on payment for rural health clinic services provided by rural health clinics (other than such clinics in hospitals with less than 50 beds), the Secretary shall establish such limit, for services provided prior to —
(A)
in 1988, after March 31, at $46 per visit, and
(B)
section 1395u(i)(3) of this titlesection 1395u(i)(4) of this title in a subsequent year (before ), at the limit established under this paragraph for the previous year increased by the percentage increase in the MEI (as defined in ) applicable to primary care services (as defined in ) furnished as of the first day of that year.
(2)
In establishing limits under subsection (a) on payment for rural health clinic services furnished on or after , by a rural health clinic (other than a rural health clinic described in paragraph (3)(B)), the Secretary shall establish such limit, for services provided—
(A)
in 2021, after March 31, at $100 per visit;
(B)
in 2022, at $113 per visit;
(C)
in 2023, at $126 per visit;
(D)
in 2024, at $139 per visit;
(E)
in 2025, at $152 per visit;
(F)
in 2026, at $165 per visit;
(G)
in 2027, at $178 per visit;
(H)
in 2028, at $190 per visit; and
(I)
in a subsequent year, at the limit established under this paragraph for the previous year increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of such subsequent year.
(3)
(A)
In establishing limits under subsection (a) on payment for rural health clinic services furnished on or after , by a rural health clinic described in subparagraph (B), the Secretary shall establish such limit, with respect to each such rural health clinic, for services provided—
(i)
in 2021, after March 31, at an amount equal to the greater of—
(I)
with respect to a rural health clinic that had a per visit payment amount established for services furnished in 2020—
(aa)
the per visit payment amount applicable to such rural health clinic for rural health clinic services furnished in 2020, increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of 2021; or
(bb)
the limit described in paragraph (2)(A); and
(II)
with respect to a rural health clinic that did not have a per visit payment amount established for services furnished in 2020—
(aa)
the per visit payment amount applicable to such rural health clinic for rural health clinic services furnished in 2021; or
(bb)
the limit described in paragraph (2)(A); and
(ii)
in a subsequent year, at an amount equal to the greater of—
(I)
the amount established under subclause (I) or (II) of clause (i), as applicable, or this subclause for the previous year with respect to such rural health clinic, increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of such subsequent year; or
(II)
the limit established under paragraph (2) for such subsequent year.
(B)
A rural health clinic described in this subparagraph is a rural health clinic that—
(i)
section 1320b–5 of this title as of , was in a hospital with less than 50 beds and after such date such hospital continues to have less than 50 beds (not taking into account any increase in the number of beds pursuant to a waiver under subsection (b)(1)(A) of during the emergency period described in subsection (g)(1)(B) of such section); and
(ii)
(I)
section 1395cc(j) of this title as of , was enrolled under (including temporary enrollment during such emergency period for such emergency period); or
(II)
section 1395cc(j) of this title submitted an application for enrollment under (or a request for such a temporary enrollment for such emergency period) that was received not later than .
(g)

Physical therapy services

(1)
(A)
section 1395x(p) of this titlell Subject to paragraphs (4) and (5), in the case of physical therapy services of the type described in and speech-language pathology services of the type described in such section through the application of section 1395x()(2) of this title, but (except as provided in paragraph (6)) not described in subsection (a)(8)(B), and physical therapy services and speech-language pathology services of such type which are furnished by a physician or as incident to physicians’ services, with respect to expenses incurred in any calendar year, no more than the amount specified in paragraph (2) for the year shall be considered as incurred expenses for purposes of subsections (a) and (b). The preceding sentence shall not apply to expenses incurred with respect to services furnished after .
(B)
section 1395x(p) of this titlell With respect to services furnished during 2018 or a subsequent year, in the case of physical therapy services of the type described in , speech-language pathology services of the type described in such section through the application of section 1395x()(2) of this title, and physical therapy services and speech-language pathology services of such type which are furnished by a physician or as incident to physicians’ services, with respect to expenses incurred in any calendar year, any amount that is more than the amount specified in paragraph (2) for the year shall not be considered as incurred expenses for purposes of subsections (a) and (b) unless the applicable requirements of paragraph (7) are met.
(2)
The amount specified in this paragraph—
(A)
for 1999, 2000, and 2001, is $1,500, and
(B)
section 1395u(i)(3) of this title for a subsequent year is the amount specified in this paragraph for the preceding year increased by the percentage increase in the MEI (as defined in ) for such subsequent year;
except that if an increase under subparagraph (B) for a year is not a multiple of $10, it shall be rounded to the nearest multiple of $10.
(3)
(A)
section 1395x(p) of this titlesection 1395x(g) of this title Subject to paragraphs (4) and (5), in the case of occupational therapy services (of the type that are described in (but (except as provided in paragraph (6)) not described in subsection (a)(8)(B)) through the operation of and of such type which are furnished by a physician or as incident to physicians’ services), with respect to expenses incurred in any calendar year, no more than the amount specified in paragraph (2) for the year shall be considered as incurred expenses for purposes of subsections (a) and (b). The preceding sentence shall not apply to expenses incurred with respect to services furnished after .
(B)
section 1395x(p) of this titlesection 1395x(g) of this title With respect to services furnished during 2018 or a subsequent year, in the case of occupational therapy services (of the type that are described in through the operation of and of such type which are furnished by a physician or as incident to physicians’ services), with respect to expenses incurred in any calendar year, any amount that is more than the amount specified in paragraph (2) for the year shall not be considered as incurred expenses for purposes of subsections (a) and (b) unless the applicable requirements of paragraph (7) are met.
(4)
This subsection shall not apply to expenses incurred with respect to services furnished during 2000, 2001, 2002, 2004, and 2005.
(5)
(A)
With respect to expenses incurred during the period beginning on , and ending on , for services, the Secretary shall implement a process under which an individual enrolled under this part may, upon request of the individual or a person on behalf of the individual, obtain an exception from the uniform dollar limitation specified in paragraph (2), for services described in paragraphs (1) and (3) if the provision of such services is determined to be medically necessary and if the requirement of subparagraph (B) is met. Under such process, if the Secretary does not make a decision on such a request for an exception within 10 business days of the date of the Secretary’s receipt of the request made in accordance with such requirement, the Secretary shall be deemed to have found the services to be medically necessary.
(B)
In the case of outpatient therapy services for which an exception is requested under the first sentence of subparagraph (A), the claim for such services shall contain an appropriate modifier (such as the KX modifier used as of ) indicating that such services are medically necessary as justified by appropriate documentation in the medical record involved.
(C)
(i)
In applying this paragraph with respect to a request for an exception with respect to expenses that would be incurred for outpatient therapy services (including services described in subsection (a)(8)(B)) that would exceed the threshold described in clause (ii) for a year, the request for such an exception, for services furnished on or after , shall be subject to a manual medical review process that, subject to subparagraph (E), is similar to the manual medical review process used for certain exceptions under this paragraph in 2006.
(ii)
The threshold under this clause for a year is $3,700. Such threshold shall be applied separately—
(I)
for physical therapy services and speech-language pathology services; and
(II)
for occupational therapy services.
(E)
(i)
6
6 So in original. There is no subpar. (D).
  In place of the manual medical review process under subparagraph (C)(i), the Secretary shall implement a process for medical review under this subparagraph under which the Secretary shall identify and conduct medical review for services described in subparagraph (C)(i) furnished by a provider of services or supplier (in this subparagraph referred to as a “therapy provider”) using such factors as the Secretary determines to be appropriate.
(ii)
Such factors may include the following:
(I)
The therapy provider has had a high claims denial percentage for therapy services under this part or is less compliant with applicable requirements under this subchapter.
(II)
The therapy provider has a pattern of billing for therapy services under this part that is aberrant compared to peers or otherwise has questionable billing practices for such services, such as billing medically unlikely units of services in a day.
(III)
The therapy provider is newly enrolled under this subchapter or has not previously furnished therapy services under this part.
(IV)
The services are furnished to treat a type of medical condition.
(V)
7
7 So in original. Probably should be preceded by “a”.
The therapy provider is part of group  that includes another therapy provider identified using the factors determined under this subparagraph.
(iii)
section 1395t of this titlesection 1395ddd(h) of this title For purposes of carrying out this subparagraph, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under , of $5,000,000 to the Centers for Medicare & Medicaid Services Program Management Account for fiscal years 2015 and 2016, to remain available until expended. Such funds may not be used by a contractor under for medical reviews under this subparagraph.
(iv)
The targeted review process under this subparagraph shall not apply to services for which expenses are incurred beyond the period for which the exceptions process under subparagraph (A) is implemented, except as such process is applied under paragraph (7)(B).
(6)
(A)
In applying paragraphs (1) and (3) to services furnished during the period beginning not later than , and ending on , the exclusion of services described in subsection (a)(8)(B) from the uniform dollar limitation specified in paragraph (2) shall not apply to such services furnished during 2012 through 2017.
(B)
(i)
section 1395m(g) of this titlesection 1395m(k)(1)(B) of this titlesection 1395m(g) of this title With respect to outpatient therapy services furnished beginning on or after , and before , for which payment is made under , the Secretary shall count toward the uniform dollar limitations described in paragraphs (1) and (3) and the threshold described in paragraph (5)(C) the amount that would be payable under this part if such services were paid under instead of being paid under .
(ii)
section 1395m(g) of this title Nothing in clause (i) shall be construed as changing the method of payment for outpatient therapy services under .
(7)
For purposes of paragraphs (1)(B) and (3)(B), with respect to services described in such paragraphs, the requirements described in this paragraph are as follows:
(A)

Inclusion of appropriate modifier

The claim for such services contains an appropriate modifier (such as the KX modifier described in paragraph (5)(B)) indicating that such services are medically necessary as justified by appropriate documentation in the medical record involved.

(B)

Targeted medical review for certain services above threshold

(i)

In general

In the case where expenses that would be incurred for such services would exceed the threshold described in clause (ii) for the year, such services shall be subject to the process for medical review implemented under paragraph (5)(E).

(ii)

Threshold

The threshold under this clause for—
(I)
a year before 2028, is $3,000;
(II)
section 1395u(i)(3) of this title 2028, is the amount specified in subclause (I) increased by the percentage increase in the MEI (as defined in ) for 2028; and
(III)
section 1395u(i)(3) of this title a subsequent year, is the amount specified in this clause for the preceding year increased by the percentage increase in the MEI (as defined in ) for such subsequent year;
except that if an increase under subclause (II) or (III) for a year is not a multiple of $10, it shall be rounded to the nearest multiple of $10.
(iii)

Application

The threshold under clause (ii) shall be applied separately—
(I)
for physical therapy services and speech-language pathology services; and
(II)
for occupational therapy services.
(iv)

Funding

section 1395t of this titlesection 1395ddd(h) of this titleFor purposes of carrying out this subparagraph, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under to the Centers for Medicare & Medicaid Services Program Management Account, of $5,000,000 for each fiscal year beginning with fiscal year 2018, to remain available until expended. Such funds may not be used by a contractor under for medical reviews under this subparagraph.

(8)
section 1395pp of this titlesection 1395y(a)(1) of this title With respect to services furnished on or after , where payment may not be made as a result of application of paragraphs (1) and (3), shall apply in the same manner as such section applies to a denial that is made by reason of .
(h)

Fee schedules for clinical diagnostic laboratory tests; percentage of prevailing charge level; nominal fee for samples; adjustments; recipients of payments; negotiated payment rate

(1)
(A)
section 1395m(d)(1) of this titleoo Subject to , the Secretary shall establish fee schedules for clinical diagnostic laboratory tests (including prostate cancer screening tests under section 1395x() of this title consisting of prostate-specific antigen blood tests) for which payment is made under this part, other than such tests performed by a provider of services for an inpatient of such provider.
(B)
In the case of clinical diagnostic laboratory tests performed by a physician or by a laboratory (other than tests performed by a qualified hospital laboratory (as defined in subparagraph (D)) for outpatients of such hospital), the fee schedules established under subparagraph (A) shall be established on a regional, statewide, or carrier service area basis (as the Secretary may determine to be appropriate) for tests furnished on or after .
(C)
In the case of clinical diagnostic laboratory tests performed by a qualified hospital laboratory (as defined in subparagraph (D)) for outpatients of such hospital, the fee schedules established under subparagraph (A) shall be established on a regional, statewide, or carrier service area basis (as the Secretary may determine to be appropriate) for tests furnished on or after .
(D)
section 1395ww(d)(5)(D)(iii) of this title In this subsection, the term “qualified hospital laboratory” means a hospital laboratory, in a sole community hospital (as defined in ), which provides some clinical diagnostic laboratory tests 24 hours a day in order to serve a hospital emergency room which is available to provide services 24 hours a day and 7 days a week.
(2)
(A)
(i)
section 1395u(b)(3) of this title Except as provided in clause (v), subparagraph (B), and paragraph (4), the Secretary shall set the fee schedules at 60 percent (or, in the case of a test performed by a qualified hospital laboratory (as defined in paragraph (1)(D)) for outpatients of such hospital, 62 percent) of the prevailing charge level determined pursuant to the third and fourth sentences of for similar clinical diagnostic laboratory tests for the applicable region, State, or area for the 12-month period beginning , adjusted annually (to become effective on January 1 of each year) by, subject to clause (iv), a percentage increase or decrease equal to the percentage increase or decrease in the Consumer Price Index for All Urban Consumers (United States city average) minus, for each of the years 2009 and 2010, 0.5 percentage points, and, for tests furnished before , subject to such other adjustments as the Secretary determines are justified by technological changes.
(ii)
Notwithstanding clause (i)—
(I)
any change in the fee schedules which would have become effective under this subsection for tests furnished on or after , shall not be effective for tests furnished during the 3-month period beginning on ,
(II)
the Secretary shall not adjust the fee schedules under clause (i) to take into account any increase in the consumer price index for 1988,
(III)
the annual adjustment in the fee schedules determined under clause (i) for each of the years 1991, 1992, and 1993 shall be 2 percent, and
(IV)
the annual adjustment in the fee schedules determined under clause (i) for each of the years 1994 and 1995, 1998 through 2002, and 2004 through 2008 shall be 0 percent.
(iii)
section 1395u(b)(3) of this title In establishing fee schedules under clause (i) with respect to automated tests and tests (other than cytopathology tests) which before , the Secretary made subject to a limit based on lowest charge levels under the sixth sentence of performed after , the Secretary shall reduce by 8.3 percent the fee schedules otherwise established for 1988, and such reduced fee schedules shall serve as the base for 1989 and subsequent years.
(iv)
After determining the adjustment to the fee schedules under clause (i), the Secretary shall reduce such adjustment—
(I)
section 1395ww(b)(3)(B)(xi)(II) of this title for 2011 and each subsequent year, by the productivity adjustment described in ; and
(II)
for each of 2011 through 2015, by 1.75 percentage points.
Subclause (I) shall not apply in a year where the adjustment to the fee schedules determined under clause (i) is 0.0 or a percentage decrease for a year. The application of the productivity adjustment under subclause (I) shall not result in an adjustment to the fee schedules under clause (i) being less than 0.0 for a year. The application of subclause (II) may result in an adjustment to the fee schedules under clause (i) being less than 0.0 for a year, and may result in payment rates for a year being less than such payment rates for the preceding year.
(v)
The Secretary shall reduce by 2 percent the fee schedules otherwise determined under clause (i) for 2013, and such reduced fee schedules shall serve as the base for 2014 and subsequent years.
(B)
The Secretary may make further adjustments or exceptions to the fee schedules to assure adequate reimbursement of (i) emergency laboratory tests needed for the provision of bona fide emergency services, and (ii) certain low volume high-cost tests where highly sophisticated equipment or extremely skilled personnel are necessary to assure quality.
(3)
section 1395m–1 of this title In addition to the amounts provided under the fee schedules (for tests furnished before ) or under (for tests furnished on or after ), subject to subsection (b)(5) of such section, the Secretary shall provide for and establish (A) a nominal fee to cover the appropriate costs in collecting the sample on which a clinical diagnostic laboratory test was performed and for which payment is made under this part, except that not more than one such fee may be provided under this paragraph with respect to samples collected in the same encounter, and (B) a fee to cover the transportation and personnel expenses for trained personnel to travel to the location of an individual to collect the sample, except that such a fee may be provided only with respect to an individual who is homebound or an inpatient in an inpatient facility (other than a hospital). In establishing a fee to cover the transportation and personnel expenses for trained personnel to travel to the location of an individual to collect a sample, the Secretary shall provide a method for computing the fee based on the number of miles traveled and the personnel costs associated with the collection of each individual sample, but the Secretary shall only be required to apply such method in the case of tests furnished during the period beginning on , and ending on , by a laboratory that establishes to the satisfaction of the Secretary (based on data for the 12-month period ending ) that (i) the laboratory is dependent upon payments under this subchapter for at least 80 percent of its collected revenues for clinical diagnostic laboratory tests, (ii) at least 85 percent of its gross revenues for such tests are attributable to tests performed with respect to individuals who are homebound or who are residents in a nursing facility, and (iii) the laboratory provided such tests for residents in nursing facilities representing at least 20 percent of the number of such facilities in the State in which the laboratory is located.
(4)
(A)
In establishing any fee schedule under this subsection, the Secretary may provide for an adjustment to take into account, with respect to the portion of the expenses of clinical diagnostic laboratory tests attributable to wages, the relative difference between a region’s or local area’s wage rates and the wage rate presumed in the data on which the schedule is based.
(B)
For purposes of subsections (a)(1)(D)(i) and (a)(2)(D)(i), the limitation amount for a clinical diagnostic laboratory test performed—
(i)
on or after , and before , is equal to 115 percent of the median of all the fee schedules established for that test for that laboratory setting under paragraph (1),
(ii)
after , and before , is equal to the median of all the fee schedules established for that test for that laboratory setting under paragraph (1),
(iii)
after , and before , is equal to 93 percent of the median of all the fee schedules established for that test for that laboratory setting under paragraph (1),
(iv)
after , and before , is equal to 88 percent of such median,
(v)
after , and before , is equal to 84 percent of such median,
(vi)
after , and before , is equal to 80 percent of such median,
(vii)
after , and before , is equal to 76 percent of such median, and
(viii)
after , is equal to 74 percent of such median (or 100 percent of such median in the case of a clinical diagnostic laboratory test performed on or after , that the Secretary determines is a new test for which no limitation amount has previously been established under this subparagraph).
(5)
(A)
section 1395cc of this title In the case of a bill or request for payment for a clinical diagnostic laboratory test for which payment may otherwise be made under this part on an assignment-related basis or under a provider agreement under , payment may be made only to the person or entity which performed or supervised the performance of such test; except that—
(i)
if a physician performed or supervised the performance of such test, payment may be made to another physician with whom he shares his practice,
(ii)
in the case of a test performed at the request of a laboratory by another laboratory, payment may be made to the referring laboratory but only if—
(I)
the referring laboratory is located in, or is part of, a rural hospital,
(II)
the referring laboratory is wholly owned by the entity performing such test, the referring laboratory wholly owns the entity performing such test, or both the referring laboratory and the entity performing such test are wholly-owned by a third entity, or
(III)
8
8 So in original. The comma after “subclause (II))” probably should follow “is performed”.
8 not more than 30 percent of the clinical diagnostic laboratory tests for which such referring laboratory (but not including a laboratory described in subclause (II)), receives requests for testing during the year in which the test is performed  are performed by another laboratory, and
(iii)
section 1395x(w)(1) of this title in the case of a clinical diagnostic laboratory test provided under an arrangement (as defined in ) made by a hospital, critical access hospital, or skilled nursing facility, payment shall be made to the hospital or skilled nursing facility.
(B)
In the case of such a bill or request for payment for a clinical diagnostic laboratory test for which payment may otherwise be made under this part, and which is not described in subparagraph (A), payment may be made to the beneficiary only on the basis of the itemized bill of the person or entity which performed or supervised the performance of the test.
(C)
section 1395cc of this title Payment for a clinical diagnostic laboratory test, including a test performed in a physician’s office but excluding a test performed by a rural health clinic may only be made on an assignment-related basis or to a provider of services with an agreement in effect under .
(D)
section 1395u(j) of this title9
9 So in original. Probably should be “such paragraph applies”.
A person may not bill for a clinical diagnostic laboratory test, including a test performed in a physician’s office but excluding a test performed by a rural health clinic, other than on an assignment-related basis. If a person knowingly and willfully and on a repeated basis bills for a clinical diagnostic laboratory test in violation of the previous sentence, the Secretary may apply sanctions against the person in the same manner as the Secretary may apply sanctions against a physician in accordance with paragraph (2) of in the same manner such paragraphs apply  with respect to a physician. Paragraph (4) of such section shall apply in this subparagraph in the same manner as such paragraph applies to such section.
(6)
For tests furnished before , in the case of any diagnostic laboratory test payment for which is not made on the basis of a fee schedule under paragraph (1), the Secretary may establish a payment rate which is acceptable to the person or entity performing the test and which would be considered the full charge for such tests. Such negotiated rate shall be limited to an amount not in excess of the total payment that would have been made for the services in the absence of such rate.
(7)
section 1395m–1 of this title Notwithstanding paragraphs (1) and (4) and , the Secretary shall establish a national minimum payment amount under this part for a diagnostic or screening pap smear laboratory test (including all cervical cancer screening technologies that have been approved by the Food and Drug Administration as a primary screening method for detection of cervical cancer) equal to $14.60 for tests furnished in 2000. For such tests furnished in subsequent years, such national minimum payment amount shall be adjusted annually as provided in paragraph (2).
(8)
(A)
The Secretary shall establish by regulation procedures for determining the basis for, and amount of, payment under this subsection for any clinical diagnostic laboratory test with respect to which a new or substantially revised HCPCS code is assigned on or after (in this paragraph referred to as “new tests”).
(B)
Determinations under subparagraph (A) shall be made only after the Secretary—
(i)
makes available to the public (through an Internet website and other appropriate mechanisms) a list that includes any such test for which establishment of a payment amount under this subsection is being considered for a year;
(ii)
on the same day such list is made available, causes to have published in the Federal Register notice of a meeting to receive comments and recommendations (and data on which recommendations are based) from the public on the appropriate basis under this subsection for establishing payment amounts for the tests on such list;
(iii)
not less than 30 days after publication of such notice convenes a meeting, that includes representatives of officials of the Centers for Medicare & Medicaid Services involved in determining payment amounts, to receive such comments and recommendations (and data on which the recommendations are based);
(iv)
taking into account the comments and recommendations (and accompanying data) received at such meeting, develops and makes available to the public (through an Internet website and other appropriate mechanisms) a list of proposed determinations with respect to the appropriate basis for establishing a payment amount under this subsection for each such code, together with an explanation of the reasons for each such determination, the data on which the determinations are based, and a request for public written comments on the proposed determination; and
(v)
taking into account the comments received during the public comment period, develops and makes available to the public (through an Internet website and other appropriate mechanisms) a list of final determinations of the payment amounts for such tests under this subsection, together with the rationale for each such determination, the data on which the determinations are based, and responses to comments and suggestions received from the public.
(C)
Under the procedures established pursuant to subparagraph (A), the Secretary shall—
(i)
set forth the criteria for making determinations under subparagraph (A); and
(ii)
make available to the public the data (other than proprietary data) considered in making such determinations.
(D)
The Secretary may convene such further public meetings to receive public comments on payment amounts for new tests under this subsection as the Secretary deems appropriate.
(E)
For purposes of this paragraph:
(i)
The term “HCPCS” refers to the Health Care Procedure Coding System.
(ii)
A code shall be considered to be “substantially revised” if there is a substantive change to the definition of the test or procedure to which the code applies (such as a new analyte or a new methodology for measuring an existing analyte-specific test).
(9)
Notwithstanding any other provision in this part, in the case of any diagnostic laboratory test for HbA1c that is labeled by the Food and Drug Administration for home use and is furnished on or after , the payment rate for such test shall be the payment rate established under this part for a glycated hemoglobin test (identified as of , by HCPCS code 83036 (and any succeeding codes)).
(i)

Outpatient surgery

(1)
The Secretary shall, in consultation with appropriate medical organizations—
(A)
section 1395k(a)(2)(F)(i) of this title specify those surgical procedures which are appropriately (when considered in terms of the proper utilization of hospital inpatient facilities) performed on an inpatient basis in a hospital but which also can be performed safely on an ambulatory basis in an ambulatory surgical center (meeting the standards specified under ), critical access hospital, or hospital outpatient department, and
(B)
specify those surgical procedures which are appropriately (when considered in terms of the proper utilization of hospital inpatient facilities) performed on an inpatient basis in a hospital but which also can be performed safely on an ambulatory basis in a physician’s office.
The lists of procedures established under subparagraphs (A) and (B) shall be reviewed and updated not less often than every 2 years, in consultation with appropriate trade and professional organizations.
(2)
(A)
For services furnished prior to the implementation of the system described in subparagraph (D), subject to subparagraph (E), the amount of payment to be made for facility services furnished in connection with a surgical procedure specified pursuant to paragraph (1)(A) and furnished to an individual in an ambulatory surgical center described in such paragraph shall be equal to 80 percent of a standard overhead amount established by the Secretary (with respect to each such procedure) on the basis of the Secretary’s estimate of a fair fee which—
(i)
takes into account the costs incurred by such centers, or classes of centers, generally in providing services furnished in connection with the performance of such procedure, as determined in accordance with a survey (based upon a representative sample of procedures and facilities) of the actual audited costs incurred by such centers in providing such services,
(ii)
takes such costs into account in such a manner as will assure that the performance of the procedure in such a center will result in substantially less amounts paid under this subchapter than would have been paid if the procedure had been performed on an inpatient basis in a hospital, and
(iii)
in the case of insertion of an intraocular lens during or subsequent to cataract surgery includes payment which is reasonable and related to the cost of acquiring the class of lens involved.
Each amount so established shall be reviewed and updated not later than , and annually thereafter to take account of varying conditions in different areas.
(B)
The amount of payment to be made under this part for facility services furnished, in connection with a surgical procedure specified pursuant to paragraph (1)(B), in a physician’s office shall be equal to 80 percent of a standard overhead amount established by the Secretary (with respect to each such procedure) on the basis of the Secretary’s estimate of a fair fee which—
(i)
takes into account additional costs, not usually included in the professional fee, incurred by physicians in securing, maintaining, and staffing the facilities and ancillary services appropriate for the performance of such procedure in the physician’s office, and
(ii)
takes such items into account in such a manner which will assure that the performance of such procedure in the physician’s office will result in substantially less amounts paid under this subchapter than would have been paid if the services had been furnished on an inpatient basis in a hospital.
Each amount so established shall be reviewed and updated not later than , and annually thereafter to take account of varying conditions in different areas.
(C)
(i)
Notwithstanding the second sentence of each of subparagraphs (A) and (B), except as otherwise specified in clauses (ii), (iii), and (iv), if the Secretary has not updated amounts established under such subparagraphs or under subparagraph (D), with respect to facility services furnished during a fiscal year (beginning with fiscal year 1986 or a calendar year (beginning with 2006)), such amounts shall be increased by the percentage increase in the Consumer Price Index for all urban consumers (U.S. city average) as estimated by the Secretary for the 12-month period ending with the midpoint of the year involved.
(ii)
In each of the fiscal years 1998 through 2002, the increase under this subparagraph shall be reduced (but not below zero) by 2.0 percentage points.
(iii)
In fiscal year 2004, beginning with , the increase under this subparagraph shall be the Consumer Price Index for all urban consumers (U.S. city average) as estimated by the Secretary for the 12-month period ending with , minus 3.0 percentage points.
(iv)
In fiscal year 2005, the last quarter of calendar year 2005, and each of calendar years 2006 through 2009, the increase under this subparagraph shall be 0 percent.
(D)
(i)
Taking into account the recommendations in the report under section 626(d) of Medicare Prescription Drug, Improvement, and Modernization Act of 2003, the Secretary shall implement a revised payment system for payment of surgical services furnished in ambulatory surgical centers.
(ii)
In the year the system described in clause (i) is implemented, such system shall be designed to result in the same aggregate amount of expenditures for such services as would be made if this subparagraph did not apply, as estimated by the Secretary and taking into account reduced expenditures that would apply if subparagraph (E) were to continue to apply, as estimated by the Secretary.
(iii)
The Secretary shall implement the system described in clause (i) for periods in a manner so that it is first effective beginning on or after , and not later than .
(iv)
The Secretary may implement such system in a manner so as to provide for a reduction in any annual update for failure to report on quality measures in accordance with paragraph (7).
(v)
section 1395ww(b)(3)(B)(xi)(II) of this title In implementing the system described in clause (i) for 2011 and each subsequent year, any annual update under such system for the year, after application of clause (iv), shall be reduced by the productivity adjustment described in . The application of the preceding sentence may result in such update being less than 0.0 for a year, and may result in payment rates under the system described in clause (i) for a year being less than such payment rates for the preceding year.
(vi)
oo There shall be no administrative or judicial review under section 1395ff, 1395 of this title, or otherwise, of the classification system, the relative weights, payment amounts, and the geographic adjustment factor, if any, under this subparagraph.
(E)
With respect to surgical procedures furnished on or after , and before the effective date of the implementation of a revised payment system under subparagraph (D), if—
(i)
the standard overhead amount under subparagraph (A) for a facility service for such procedure, without the application of any geographic adjustment, exceeds
(ii)
the Medicare OPD fee schedule amount established under the prospective payment system for hospital outpatient department services under paragraph (3)(D) of subsection (t) for such service for such year, determined without regard to geographic adjustment under paragraph (2)(D) of such subsection,
the Secretary shall substitute under subparagraph (A) the amount described in clause (ii) for the standard overhead amount for such service referred to in clause (i).
(3)
(A)
The aggregate amount of the payments to be made under this part for outpatient hospital facility services or critical access hospital services furnished before , in connection with surgical procedures specified under paragraph (1)(A) shall be equal to the lesser of—
(i)
the amount determined with respect to such services under subsection (a)(2)(B); or
(ii)
the blend amount (described in subparagraph (B)).
(B)
(i)
The blend amount for a cost reporting period is the sum of—
(I)
the cost proportion (as defined in clause (ii)(I)) of the amount described in subparagraph (A)(i), and
(II)
section 1395cc(a)(2)(A) of this title the ASC proportion (as defined in clause (ii)(II)) of the standard overhead amount payable with respect to the same surgical procedure as if it were provided in an ambulatory surgical center in the same area, as determined under paragraph (2)(A), less the amount a provider may charge as described in clause (ii) of .
(ii)
Subject to paragraph (4), in this paragraph:
(I)
The term “cost proportion” means 75 percent for cost reporting periods beginning in fiscal year 1988, 50 percent for portions of cost reporting periods beginning on or after , and ending on or before , and 42 percent for portions of cost reporting periods beginning on or after .
(II)
The term “ASC proportion” means 25 percent for cost reporting periods beginning in fiscal year 1988, 50 percent for portions of cost reporting periods beginning on or after , and ending on or before , and 58 percent for portions of cost reporting periods beginning on or after .
(4)
(A)
In the case of a hospital that—
(i)
makes application to the Secretary and demonstrates that it specializes in eye services or eye and ear services (as determined by the Secretary),
(ii)
receives more than 30 percent of its total revenues from outpatient services, and
(iii)
on —
(I)
was an eye specialty hospital or an eye and ear specialty hospital, or
(II)
was operated as an eye or eye and ear unit (as defined in subparagraph (B)) of a general acute care hospital which, on the date of the application described in clause (i), operates less than 20 percent of the beds that the hospital operated on , and has sold or otherwise disposed of a substantial portion of the hospital’s other acute care operations,
the cost proportion and ASC proportion in effect under subclauses (I) and (II) of paragraph (3)(B)(ii) for cost reporting periods beginning in fiscal year 1988 shall remain in effect for cost reporting periods beginning on or after , and before .
(B)
10
10 So in original. The word “this” probably should not appear.
For purposes of this  subparagraph (A)(iii)(II), the term “eye or eye and ear unit” means a physically separate or distinct unit containing separate surgical suites devoted solely to eye or eye and ear services.
(5)
(A)
The Secretary is authorized to provide by regulations that in the case of a surgical procedure, specified by the Secretary pursuant to paragraph (1)(A), performed in an ambulatory surgical center described in such paragraph, there shall be paid (in lieu of any amounts otherwise payable under this part) with respect to the facility services furnished by such center and with respect to all related services (including physicians’ services, laboratory, X-ray, and diagnostic services) a single all-inclusive fee established pursuant to subparagraph (B), if all parties furnishing all such services agree to accept such fee (to be divided among the parties involved in such manner as they shall have previously agreed upon) as full payment for the services furnished.
(B)
In implementing this paragraph, the Secretary shall establish with respect to each surgical procedure specified pursuant to paragraph (1)(A) the amount of the all-inclusive fee for such procedure, taking into account such factors as may be appropriate. The amount so established with respect to any surgical procedure shall be reviewed periodically and may be adjusted by the Secretary, when appropriate, to take account of varying conditions in different areas.
(6)
section 1395k(a)(2)(F)(i) of this titlesection 1320a–7a of this titlesection 1320a–7a(a) of this title Any person, including a facility having an agreement under , who knowingly and willfully presents, or causes to be presented, a bill or request for payment, for an intraocular lens inserted during or subsequent to cataract surgery for which payment may be made under paragraph (2)(A)(iii), is subject to a civil money penalty of not to exceed $2,000. The provisions of (other than subsections (a) and (b)) shall apply to a civil money penalty under the previous sentence in the same manner as such provisions apply to a penalty or proceeding under .
(7)
(A)
For purposes of paragraph (2)(D)(iv), the Secretary may provide, in the case of an ambulatory surgical center that does not submit, to the Secretary in accordance with this paragraph, data required to be submitted on measures selected under this paragraph with respect to a year, any annual increase provided under the system established under paragraph (2)(D) for such year shall be reduced by 2.0 percentage points. A reduction under this subparagraph shall apply only with respect to the year involved and the Secretary shall not take into account such reduction in computing any annual increase factor for a subsequent year.
(B)
Except as the Secretary may otherwise provide, the provisions of subparagraphs (B), (C), (D), and (E) of paragraph (17) of subsection (t) shall apply with respect to services of ambulatory surgical centers under this paragraph in a similar manner to the manner in which they apply under such paragraph and, for purposes of this subparagraph, any reference to a hospital, outpatient setting, or outpatient hospital services is deemed a reference to an ambulatory surgical center, the setting of such a center, or services of such a center, respectively.
(8)
l11
11 So in original. The closing parenthesis preceding the comma probably should not appear.
The Secretary shall conduct a similar type of review as required under paragraph (22) of section 1395(t) of this title), including the second sentence of subparagraph (C) of such paragraph, to payment for services under this subsection, and make such revisions under this paragraph, in an appropriate manner (as determined by the Secretary).
(9)
section 1395w–3a(i) of this titlesection 1395w–3a(i)(5) of this titlesection 1395w–3a(i)(5) of this title In the case of a part B rebatable drug (as defined in paragraph (2) of ) for which payment under this subsection is not packaged into a payment for a service furnished on or after , under the revised payment system under this subsection, in lieu of calculation of coinsurance and the amount of payment otherwise applicable under this subsection, the provisions of and paragraph (1)(EE) of subsection (a), shall, as determined appropriate by the Secretary, apply under this subsection in the same manner as such provisions of and subsection (a) apply under such section and subsection.
(10)

Temporary additional payments for non-opioid treatments for pain relief.—

(A)

In general .—

In the case of surgical services furnished on or after , and before , the payment system described in paragraph (2)(D)(i) shall provide, in a budget-neutral manner, for an additional payment for a non-opioid treatment for pain relief (as defined in clause (iv) of subsection (t)(16)(G)) furnished as part of such services in the amount specified in clause (ii) of such subsection, subject to the limitation under clause (iii) of such subsection.
(B)

Transition .—

A drug or biological that meets the requirements of section 416.174 of title 42, Code of Federal Regulations (or any successor regulation) and is a non-opioid treatment for pain relief (as defined in clause (iv) of subsection (t)(16)(G)) shall receive additional payment in the amount specified in clause (ii) of such subsection, subject to the limitation under clause (iii) of such subsection.
(j)

Accrual of interest on balance of excess or deficit not paid

section 1395u(b)(3)(B)(ii) of this titlesection 1320b–5(g)(1)(B) of this titleWhenever a final determination is made that the amount of payment made under this part either to a provider of services or to another person pursuant to an assignment under was in excess of or less than the amount of payment that is due, and payment of such excess or deficit is not made (or effected by offset) within 30 days of the date of the determination, interest shall accrue on the balance of such excess or deficit not paid or offset (to the extent that the balance is owed by or owing to the provider) at a rate determined in accordance with the regulations of the Secretary of the Treasury applicable to charges for late payments (or, in the case of such a determination made with respect to a payment made on or after , and during the emergency period described in under the program described in section 421.214 of title 42, Code of Federal Regulations (or any successor regulation), at a rate of 4 percent).

(k)

Hepatitis B vaccine

section 1395x(s)(10)(B) of this titleWith respect to services described in , the Secretary may provide, instead of the amount of payment otherwise provided under this part, for payment of such an amount or amounts as reasonably reflects the general cost of efficiently providing such services.

(l)

Fee schedule for services of certified registered nurse anesthetists

(1)
(A)
section 1395x(s)(11) of this title The Secretary shall establish a fee schedule for services of certified registered nurse anesthetists under .
(B)
In establishing the fee schedule under this paragraph the Secretary may utilize a system of time units, a system of base and time units, or any appropriate methodology.
(C)
The provisions of this subsection shall not apply to certain services furnished in certain hospitals in rural areas under the provisions of section 9320(k) of the Omnibus Budget Reconciliation Act of 1986, as amended by section 6132 of the Omnibus Budget Reconciliation Act of 1989.
(2)
Except as provided in paragraph (3), the fee schedule established under paragraph (1) shall be initially based on audited data from cost reporting periods ending in fiscal year 1985 and such other data as the Secretary determines necessary.
(3)
(A)
In establishing the initial fee schedule for those services, the Secretary shall adjust the fee schedule to the extent necessary to ensure that the estimated total amount which will be paid under this subchapter for those services plus applicable coinsurance in 1989 will equal the estimated total amount which would be paid under this subchapter for those services in 1989 if the services were included as inpatient hospital services and payment for such services was made under part A in the same manner as payment was made in fiscal year 1987, adjusted to take into account changes in prices and technology relating to the administration of anesthesia.
(B)
section 1395u(b)(3) of this title The Secretary shall also reduce the prevailing charge of physicians for medical direction of a certified registered nurse anesthetist, or the fee schedule for services of certified registered nurse anesthetists, or both, to the extent necessary to ensure that the estimated total amount which will be paid under this subchapter plus applicable coinsurance for such medical direction and such services in 1989 and 1990 will not exceed the estimated total amount which would have been paid plus applicable coinsurance but for the enactment of the amendments made by section 9320 of the Omnibus Budget Reconciliation Act of 1986. A reduced prevailing charge under this subparagraph shall become the prevailing charge but for subsequent years for purposes of applying the economic index under the fourth sentence of .
(4)
(A)
Except as provided in subparagraphs (C) and (D), in determining the amount paid under the fee schedule under this subsection for services furnished on or after , by a certified registered nurse anesthetist who is not medically directed—
(i)
the conversion factor shall be—
(I)
for services furnished in 1991, $15.50,
(II)
for services furnished in 1992, $15.75,
(III)
for services furnished in 1993, $16.00,
(IV)
for services furnished in 1994, $16.25,
(V)
for services furnished in 1995, $16.50,
(VI)
for services furnished in 1996, $16.75, and
(VII)
section 1395w–4(d) of this title for services furnished in calendar years after 1996, the previous year’s conversion factor increased by the update determined under for physician anesthesia services for that year;
(ii)
section 1395w–4 of this titlesection 1395u(b) of this title the payment areas to be used shall be the fee schedule areas used under (or, in the case of services furnished during 1991, the localities used under ) for purposes of computing payments for physicians’ services that are anesthesia services;
(iii)
12
12 So in original. Probably should be “are—”.
the geographic adjustment factors to be applied to the conversion factor under clause (i) for services in a fee schedule area or locality is— 
(I)
section 1395u(q)(1)(B) of this title in the case of services furnished in 1991, the geographic work index value and the geographic practice cost index value specified in for physicians’ services that are anesthesia services furnished in the area or locality, and
(II)
section 1395w–4 of this title in the case of services furnished after 1991, the geographic work index value, the geographic practice cost index value, and the geographic malpractice index value used for determining payments for physicians’ services that are anesthesia services under ,
section 1395w–4 of this titlewith 70 percent of the conversion factor treated as attributable to work and 30 percent as attributable to overhead for services furnished in 1991 (and the portions attributable to work, practice expenses, and malpractice expenses in 1992 and thereafter being the same as is applied under ).
(B)
(i)
Except as provided in clause (ii) and subparagraph (D), in determining the amount paid under the fee schedule under this subsection for services furnished on or after , and before , by a certified registered nurse anesthetist who is medically directed, the Secretary shall apply the same methodology specified in subparagraph (A).
(ii)
The conversion factor used under clause (i) shall be—
(I)
for services furnished in 1991, $10.50,
(II)
for services furnished in 1992, $10.75, and
(III)
for services furnished in 1993, $11.00.
(iii)
section 1395w–4(a)(5)(B) of this title In the case of services of a certified registered nurse anesthetist who is medically directed or medically supervised by a physician which are furnished on or after , the fee schedule amount shall be one-half of the amount described in with respect to the physician.
(C)
Notwithstanding subclauses (I) through (V) of subparagraph (A)(i)—
(i)
in the case of a 1990 conversion factor that is greater than $16.50, the conversion factor for a calendar year after 1990 and before 1996 shall be the 1990 conversion factor reduced by the product of the last digit of the calendar year and one-fifth of the amount by which the 1990 conversion factor exceeds $16.50; and
(ii)
in the case of a 1990 conversion factor that is greater than $15.49 but less than $16.51, the conversion factor for a calendar year after 1990 and before 1996 shall be the greater of—
(I)
the 1990 conversion factor, or
(II)
the conversion factor specified in subparagraph (A)(i) for the year involved.
(D)
13
13 So in original. Probably should be “subparagraph”.
Notwithstanding subparagraph (C), in no case may the conversion factor used to determine payment for services in a fee schedule area or locality under this subsection, as adjusted by the adjustment factors specified in subparagraphs  (A)(iii), exceed the conversion factor used to determine the amount paid for physicians’ services that are anesthesia services in the area or locality.
(5)
(A)
Payment for the services of a certified registered nurse anesthetist (for which payment may otherwise be made under this part) may be made on the basis of a claim or request for payment presented by the certified registered nurse anesthetist furnishing such services, or by a hospital, critical access hospital, physician, group practice, or ambulatory surgical center with which the certified registered nurse anesthetist furnishing such services has an employment or contractual relationship that provides for payment to be made under this part for such services to such hospital, critical access hospital, physician, group practice, or ambulatory surgical center.
(B)
No hospital or critical access hospital that presents a claim or request for payment for services of a certified nurse anesthetist under this part may treat any uncollected coinsurance amount imposed under this part with respect to such services as a bad debt of such hospital or critical access hospital for purposes of this subchapter.
(6)
section 1395u(j)(1)(D) of this title If an adjustment under paragraph (3)(B) results in a reduction in the reasonable charge for a physicians’ service and a nonparticipating physician furnishes the service to an individual entitled to benefits under this part after the effective date of the reduction, the physician’s actual charge is subject to a limit under .
(m)

Incentive payments for physicians’ services furnished in underserved areas

(1)
section 254e(a)(1)(A) of this titlesection 1395u(b)(6) of this title In the case of physicians’ services furnished in a year to an individual, who is covered under the insurance program established by this part and who incurs expenses for such services, in an area that is designated (under ) as a health professional shortage area as identified by the Secretary prior to the beginning of such year, in addition to the amount otherwise paid under this part, there also shall be paid to the physician (or to an employer or facility in the cases described in clause (A) of ) (on a monthly or quarterly basis) from the Federal Supplementary Medical Insurance Trust Fund an amount equal to 10 percent of the payment amount for the service under this part.
(2)
For each health professional shortage area identified in paragraph (1) that consists of an entire county, the Secretary shall provide for the additional payment under paragraph (1) without any requirement on the physician to identify the health professional shortage area involved. The Secretary may implement the previous sentence using the method specified in subsection (u)(4)(C).
(3)
The Secretary shall post on the Internet website of the Centers for Medicare & Medicaid Services a list of the health professional shortage areas identified in paragraph (1) that consist of a partial county to facilitate the additional payment under paragraph (1) in such areas.
(4)
section 1395ff of this titleoo There shall be no administrative or judicial review under , section 1395 of this title, or otherwise, respecting—
(A)
the identification of a county or area;
(B)
the assignment of a specialty of any physician under this paragraph;
(C)
the assignment of a physician to a county under this subsection; or
(D)
the assignment of a postal ZIP Code to a county or other area under this subsection.
(n)

Payments to hospital outpatient departments for radiology; amount; definitions

(1)
(A)
14
14 So in original. No par. (2) has been enacted.
  The aggregate amount of the payments to be made for all or part of a cost reporting period for services described in subsection (a)(2)(E)(i) furnished under this part on or after , and before , and for services described in subsection (a)(2)(E)(ii) furnished under this part on or after , and before , shall be equal to the lesser of—
(i)
the amount determined with respect to such services under subsection (a)(2)(B), or
(ii)
the blend amount for radiology services and diagnostic procedures determined in accordance with subparagraph (B).
(B)
(i)
The blend amount for radiology services and diagnostic procedures for a cost reporting period is the sum of—
(I)
the cost proportion (as defined in clause (ii)) of the amount described in subparagraph (A)(i); and
(II)
section 1395u(b) of this titlesection 1395w–4 of this titlesection 1395cc(a)(2)(A) of this title the charge proportion (as defined in clause (ii)(II)) of 62 percent (for services described in subsection (a)(2)(E)(i)), or (for procedures described in subsection (a)(2)(E)(ii)), 42 percent or such other percent established by the Secretary (or carriers acting pursuant to guidelines issued by the Secretary) based on prevailing charges established with actual charge data, of the prevailing charge or (for services described in subsection (a)(2)(E)(i) furnished on or after and for services described in subsection (a)(2)(E)(ii) furnished on or after ) the fee schedule amount established for participating physicians for the same services as if they were furnished in a physician’s office in the same locality as determined under (or, in the case of services furnished on or after , under ), less the amount a provider may charge as described in clause (ii) of .
(ii)
In this subparagraph:
(I)
The term “cost proportion” means 50 percent, except that such term means 65 percent in the case of outpatient radiology services for portions of cost reporting periods which occur in fiscal year 1989 and in the case of diagnostic procedures described in subsection (a)(2)(E)(ii) for portions of cost reporting periods which occur in fiscal year 1990, and such term means 42 percent in the case of outpatient radiology services for portions of cost reporting periods beginning on or after .
(II)
The term “charge proportion” means 100 percent minus the cost proportion.
(o)

Limitation on benefit for payment for therapeutic shoes for individuals with severe diabetic foot disease

(1)
section 1395x(s)(12) of this title In the case of shoes described in —
(A)
no payment may be made under this part, with respect to any individual for any year, for the furnishing of—
(i)
more than one pair of custom molded shoes (including inserts provided with such shoes) and 2 additional pairs of inserts for such shoes, or
(ii)
more than one pair of extra-depth shoes (not including inserts provided with such shoes) and 3 pairs of inserts for such shoes, and
(B)
with respect to expenses incurred in any calendar year, no more than the amount of payment applicable under paragraph (2) shall be considered as incurred expenses for purposes of subsections (a) and (b).
Payment for shoes (or inserts) under this part shall be considered to include payment for any expenses for the fitting of such shoes (or inserts).
(2)
(A)
section 1395m(h) of this title Except as provided by the Secretary under subparagraphs (B) and (C), the amount of payment under this paragraph for custom molded shoes, extra-depth shoes, and inserts shall be the amount determined for such items by the Secretary under .
(B)
section 1395m(h) of this title The Secretary may establish payment amounts for shoes and inserts that are lower than the amount established under if the Secretary finds that shoes and inserts of an appropriate quality are readily available at or below the amount established under such section.
(C)
section 1395x(s)(12) of this titlesection 1395m(h) of this title In accordance with procedures established by the Secretary, an individual entitled to benefits with respect to shoes described in may substitute modification of such shoes instead of obtaining one (or more, as specified by the Secretary) pair of inserts (other than the original pair of inserts with respect to such shoes). In such case, the Secretary shall substitute, for the payment amount established under , a payment amount that the Secretary estimates will assure that there is no net increase in expenditures under this subsection as a result of this subparagraph.
(3)
In this subchapter, the term “shoes” includes, except for purposes of subparagraphs (A)(ii) and (B) of paragraph (2), inserts for extra-depth shoes.
(p)

Pub. L. 103–432, title I, § 123(b)(2)(A)(ii)108 Stat. 4411 Repealed. , ,

(q)

Requests for payment to include information on referring physician

(1)
section 1395nn of this title Each request for payment, or bill submitted, for an item or service furnished by an entity for which payment may be made under this part and for which the entity knows or has reason to believe there has been a referral by a referring physician (within the meaning of ) shall include the name and unique physician identification number for the referring physician.
(2)
(A)
In the case of a request for payment for an item or service furnished by an entity under this part on an assignment-related basis and for which information is required to be provided under paragraph (1) but not included, payment may be denied under this part.
(B)
In the case of a request for payment for an item or service furnished by an entity under this part not submitted on an assignment-related basis and for which information is required to be provided under paragraph (1) but not included—
(i)
if the entity knowingly and willfully fails to provide such information promptly upon request of the Secretary or a carrier, the entity may be subject to a civil money penalty in an amount not to exceed $2,000, and
(ii)
section 1320a–7 of this title if the entity knowingly, willfully, and in repeated cases fails, after being notified by the Secretary of the obligations and requirements of this subsection to provide the information required under paragraph (1), the entity may be subject to exclusion from participation in the programs under this chapter for a period not to exceed 5 years, in accordance with the procedures of subsections (c), (f), and (g) of .
section 1320a–7a of this titlesection 1320a–7a(a) of this titleThe provisions of (other than subsections (a) and (b)) shall apply to civil money penalties under clause (i) in the same manner as they apply to a penalty or proceeding under .
(r)

Cap on prevailing charge; billing on assignment-related basis

(1)
section 1395x(s)(2)(K)(ii) of this titlesection 1396r(a) of this title With respect to services described in (relating to nurse practitioner or clinical nurse specialist services), payment may be made on the basis of a claim or request for payment presented by the nurse practitioner or clinical nurse specialist furnishing such services, or by a hospital, critical access hospital, skilled nursing facility or nursing facility (as defined in ), physician, group practice, or ambulatory surgical center with which the nurse practitioner or clinical nurse specialist has an employment or contractual relationship that provides for payment to be made under this part for such services to such hospital, physician, group practice, or ambulatory surgical center.
(2)
section 1395x(s)(2)(K)(ii) of this title No hospital or critical access hospital that presents a claim or request for payment under this part for services described in may treat any uncollected coinsurance amount imposed under this part with respect to such services as a bad debt of such hospital for purposes of this subchapter.
(s)

Other prepaid organizations

section 1395cc(f) of this titleThe Secretary may not provide for payment under subsection (a)(1)(A) with respect to an organization unless the organization provides assurances satisfactory to the Secretary that the organization meets the requirement of (relating to maintaining written policies and procedures respecting advance directives).

(t)

Prospective payment system for hospital outpatient department services

(1)

Amount of payment

(A)

In general

With respect to covered OPD services (as defined in subparagraph (B)) furnished during a year beginning with 1999, the amount of payment under this part shall be determined under a prospective payment system established by the Secretary in accordance with this subsection.

(B)

Definition of covered OPD services

For purposes of this subsection, the term “covered OPD services”—
(i)
means hospital outpatient services designated by the Secretary;
(ii)
subject to clause (iv), includes inpatient hospital services designated by the Secretary that are covered under this part and furnished to a hospital inpatient who (I) is entitled to benefits under part A but has exhausted benefits for inpatient hospital services during a spell of illness, or (II) is not so entitled;
(iii)
section 1395x(s) of this title includes implantable items described in paragraph (3), (6), or (8) of ;
(iv)
section 1395m(k) of this titlelsection 1395x(jj) of this titlesection 1395x(hhh)(1) of this title does not include any therapy services described in subsection (a)(8) or ambulance services, for which payment is made under a fee schedule described in or section 1395m() of this title and does not include screening mammography (as defined in ), diagnostic mammography, or personalized prevention plan services (as defined in ); and
(v)
does not include applicable items and services (as defined in subparagraph (A) of paragraph (21)) that are furnished on or after , by an off-campus outpatient department of a provider (as defined in subparagraph (B) of such paragraph).
(2)

System requirements

Under the payment system—
(A)
the Secretary shall develop a classification system for covered OPD services;
(B)
the Secretary may establish groups of covered OPD services, within the classification system described in subparagraph (A), so that services classified within each group are comparable clinically and with respect to the use of resources and so that an implantable item is classified to the group that includes the service to which the item relates;
(C)
the Secretary shall, using data on claims from 1996 and using data from the most recent available cost reports, establish relative payment weights for covered OPD services (and any groups of such services described in subparagraph (B)) based on median (or, at the election of the Secretary, mean) hospital costs and shall determine projections of the frequency of utilization of each such service (or group of services) in 1999;
(D)
subject to paragraph (19), the Secretary shall determine a wage adjustment factor to adjust the portion of payment and coinsurance attributable to labor-related costs for relative differences in labor and labor-related costs across geographic regions in a budget neutral manner;
(E)
the Secretary shall establish, in a budget neutral manner, outlier adjustments under paragraph (5) and transitional pass-through payments under paragraph (6) and temporary additional payments for non-opioid treatments for pain relief under paragraph (16)(G), and other adjustments as determined to be necessary to ensure equitable payments, such as adjustments for certain classes of hospitals;
(F)
the Secretary shall develop a method for controlling unnecessary increases in the volume of covered OPD services;
(G)
the Secretary shall create additional groups of covered OPD services that classify separately those procedures that utilize contrast agents from those that do not; and
(H)
with respect to devices of brachytherapy consisting of a seed or seeds (or radioactive source), the Secretary shall create additional groups of covered OPD services that classify such devices separately from the other services (or group of services) paid for under this subsection in a manner reflecting the number, isotope, and radioactive intensity of such devices furnished, including separate groups for palladium-103 and iodine-125 devices and for stranded and non-stranded devices furnished on or after .
section 360bb of title 21For purposes of subparagraph (B), items and services within a group shall not be treated as “comparable with respect to the use of resources” if the highest median cost (or mean cost, if elected by the Secretary under subparagraph (C)) for an item or service within the group is more than 2 times greater than the lowest median cost (or mean cost, if so elected) for an item or service within the group; except that the Secretary may make exceptions in unusual cases, such as low volume items and services, but may not make such an exception in the case of a drug or biological that has been designated as an orphan drug under .
(3)

Calculation of base amounts

(A)

Aggregate amounts that would be payable if deductibles were disregarded

The Secretary shall estimate the sum of—
(i)
the total amounts that would be payable from the Trust Fund under this part for covered OPD services in 1999, determined without regard to this subsection, as though the deductible under subsection (b) did not apply, and
(ii)
the total amounts of copayments estimated to be paid under this subsection by beneficiaries to hospitals for covered OPD services in 1999, as though the deductible under subsection (b) did not apply.
(B)

Unadjusted copayment amount

(i)

In general

For purposes of this subsection, subject to clause (ii), the “unadjusted copayment amount” applicable to a covered OPD service (or group of such services) is 20 percent of the national median of the charges for the service (or services within the group) furnished during 1996, updated to 1999 using the Secretary’s estimate of charge growth during the period.

(ii)

Adjusted to be 20 percent when fully phased in

If the pre-deductible payment percentage for a covered OPD service (or group of such services) furnished in a year would be equal to or exceed 80 percent, then the unadjusted copayment amount shall be 20 percent of amount determined under subparagraph (D).

(iii)

Rules for new services

The Secretary shall establish rules for establishment of an unadjusted copayment amount for a covered OPD service not furnished during 1996, based upon its classification within a group of such services.

(C)

Calculation of conversion factors

(i)

For 1999

(I)

In general

The Secretary shall establish a 1999 conversion factor for determining the medicare OPD fee schedule amounts for each covered OPD service (or group of such services) furnished in 1999. Such conversion factor shall be established on the basis of the weights and frequencies described in paragraph (2)(C) and in such a manner that the sum for all services and groups of the products (described in subclause (II) for each such service or group) equals the total projected amount described in subparagraph (A).

(II)

Product described

The Secretary shall determine for each service or group the product of the medicare OPD fee schedule amounts (taking into account appropriate adjustments described in paragraphs (2)(D) and (2)(E)) and the estimated frequencies for such service or group.

(ii)

Subsequent years

Subject to paragraph (8)(B), the Secretary shall establish a conversion factor for covered OPD services furnished in subsequent years in an amount equal to the conversion factor established under this subparagraph and applicable to such services furnished in the previous year increased by the OPD fee schedule increase factor specified under clause (iv) for the year involved.

(iii)

Adjustment for service mix changes

Insofar as the Secretary determines that the adjustments for service mix under paragraph (2) for a previous year (or estimates that such adjustments for a future year) did (or are likely to) result in a change in aggregate payments under this subsection during the year that are a result of changes in the coding or classification of covered OPD services that do not reflect real changes in service mix, the Secretary may adjust the conversion factor computed under this subparagraph for subsequent years so as to eliminate the effect of such coding or classification changes.

(iv)

OPD fee schedule increase factor

section 1395ww(b)(3)(B)(iii) of this titleFor purposes of this subparagraph, subject to paragraph (17) and subparagraph (F) of this paragraph, the “OPD fee schedule increase factor” for services furnished in a year is equal to the market basket percentage increase applicable under to hospital discharges occurring during the fiscal year ending in such year, reduced by 1 percentage point for such factor for services furnished in each of 2000 and 2002. In applying the previous sentence for years beginning with 2000, the Secretary may substitute for the market basket percentage increase an annual percentage increase that is computed and applied with respect to covered OPD services furnished in a year in the same manner as the market basket percentage increase is determined and applied to inpatient hospital services for discharges occurring in a fiscal year.

(D)

Calculation of medicare OPD fee schedule amounts

The Secretary shall compute a medicare OPD fee schedule amount for each covered OPD service (or group of such services) furnished in a year, in an amount equal to the product of—
(i)
the conversion factor computed under subparagraph (C) for the year, and
(ii)
the relative payment weight (determined under paragraph (2)(C)) for the service or group.
(E)

Pre-deductible payment percentage

The pre-deductible payment percentage for a covered OPD service (or group of such services) furnished in a year is equal to the ratio of—
(i)
the medicare OPD fee schedule amount established under subparagraph (D) for the year, minus the unadjusted copayment amount determined under subparagraph (B) for the service or group, to
(ii)
the medicare OPD fee schedule amount determined under subparagraph (D) for the year for such service or group.
(F)

Productivity and other adjustment

After determining the OPD fee schedule increase factor under subparagraph (C)(iv), the Secretary shall reduce such increase factor—
(i)
section 1395ww(b)(3)(B)(xi)(II) of this title for 2012 and subsequent years, by the productivity adjustment described in ; and
(ii)
for each of 2010 through 2019, by the adjustment described in subparagraph (G).
The application of this subparagraph may result in the increase factor under subparagraph (C)(iv) being less than 0.0 for a year, and may result in payment rates under the payment system under this subsection for a year being less than such payment rates for the preceding year.
(G)

Other adjustment

For purposes of subparagraph (F)(ii), the adjustment described in this subparagraph is—
(i)
for each of 2010 and 2011, 0.25 percentage point;
(ii)
for each of 2012 and 2013, 0.1 percentage point;
(iii)
for 2014, 0.3 percentage point;
(iv)
for each of 2015 and 2016, 0.2 percentage point; and
(v)
for each of 2017, 2018, and 2019, 0.75 percentage point.
(4)

Medicare payment amount

The amount of payment made from the Trust Fund under this part for a covered OPD service (and such services classified within a group) furnished in a year is determined, subject to paragraph (7), as follows:
(A)

Fee schedule adjustments

The medicare OPD fee schedule amount (computed under paragraph (3)(D)) for the service or group and year is adjusted for relative differences in the cost of labor and other factors determined by the Secretary, as computed under paragraphs (2)(D) and (2)(E).

(B)

Subtract applicable deductible

Reduce the adjusted amount determined under subparagraph (A) by the amount of the deductible under subsection (b), to the extent applicable.

(C)

Apply payment proportion to remainder

The amount of payment is the amount so determined under subparagraph (B) multiplied by the pre-deductible payment percentage (as determined under paragraph (3)(E)) for the service or group and year involved, plus the amount of any reduction in the copayment amount attributable to paragraph (8)(C).

(5)

Outlier adjustment

(A)

In general

Subject to subparagraph (D), the Secretary shall provide for an additional payment for each covered OPD service (or group of services) for which a hospital’s charges, adjusted to cost, exceed—
(i)
a fixed multiple of the sum of—
(I)
the applicable medicare OPD fee schedule amount determined under paragraph (3)(D), as adjusted under paragraph (4)(A) (other than for adjustments under this paragraph or paragraph (6)); and
(II)
any transitional pass-through payment under paragraph (6); and
(ii)
at the option of the Secretary, such fixed dollar amount as the Secretary may establish.
(B)

Amount of adjustment

The amount of the additional payment under subparagraph (A) shall be determined by the Secretary and shall approximate the marginal cost of care beyond the applicable cutoff point under such subparagraph.

(C)

Limit on aggregate outlier adjustments

(i)

In general

The total of the additional payments made under this paragraph for covered OPD services furnished in a year (as estimated by the Secretary before the beginning of the year) may not exceed the applicable percentage (specified in clause (ii)) of the total program payments estimated to be made under this subsection for all covered OPD services furnished in that year. If this paragraph is first applied to less than a full year, the previous sentence shall apply only to the portion of such year.

(ii)

Applicable percentage

For purposes of clause (i), the term “applicable percentage” means a percentage specified by the Secretary up to (but not to exceed)—
(I)
for a year (or portion of a year) before 2004, 2.5 percent; and
(II)
for 2004 and thereafter, 3.0 percent.
(D)

Transitional authority

In applying subparagraph (A) for covered OPD services furnished before , the Secretary may—
(i)
apply such subparagraph to a bill for such services related to an outpatient encounter (rather than for a specific service or group of services) using OPD fee schedule amounts and transitional pass-through payments covered under the bill; and
(ii)
use an appropriate cost-to-charge ratio for the hospital involved (as determined by the Secretary), rather than for specific departments within the hospital.
(E)

Exclusion of separate drug and biological APCS from outlier payments

No additional payment shall be made under subparagraph (A) in the case of ambulatory payment classification groups established separately for drugs or biologicals.

(6)

Transitional pass-through for additional costs of innovative medical devices, drugs, and biologicals

(A)

In general

The Secretary shall provide for an additional payment under this paragraph for any of the following that are provided as part of a covered OPD service (or group of services):
(i)

Current orphan drugs

section 360bb of title 21A drug or biological that is used for a rare disease or condition with respect to which the drug or biological has been designated as an orphan drug under if payment for the drug or biological as an outpatient hospital service under this part was being made on the first date that the system under this subsection is implemented.

(ii)

Current cancer therapy drugs and biologicals and brachytherapy

A drug or biological that is used in cancer therapy, including (but not limited to) a chemotherapeutic agent, an antiemetic, a hematopoietic growth factor, a colony stimulating factor, a biological response modifier, a bisphosphonate, and a device of brachytherapy or temperature monitored cryoablation, if payment for such drug, biological, or device as an outpatient hospital service under this part was being made on such first date.

(iii)

Current radiopharmaceutical drugs and biological products

A radiopharmaceutical drug or biological product used in diagnostic, monitoring, and therapeutic nuclear medicine procedures if payment for the drug or biological as an outpatient hospital service under this part was being made on such first date.

(iv)

New medical devices, drugs, and biologicals

A medical device, drug, or biological not described in clause (i), (ii), or (iii) if—
(I)
payment for the device, drug, or biological as an outpatient hospital service under this part was not being made as of ; and
(II)
the cost of the drug or biological or the average cost of the category of devices is not insignificant in relation to the OPD fee schedule amount (as calculated under paragraph (3)(D)) payable for the service (or group of services) involved.
(B)

Use of categories in determining eligibility of a device for pass-through payments

The following provisions apply for purposes of determining whether a medical device qualifies for additional payments under clause (ii) or (iv) of subparagraph (A):
(i)

Establishment of initial categories

(I)

In general

The Secretary shall initially establish under this clause categories of medical devices based on type of device by . Such categories shall be established in a manner such that each medical device that meets the requirements of clause (ii) or (iv) of subparagraph (A) as of , is included in such a category and no such device is included in more than one category. For purposes of the preceding sentence, whether a medical device meets such requirements as of such date shall be determined on the basis of the program memoranda issued before such date.

(II)

Authorization of implementation other than through regulations

The categories may be established under this clause by program memorandum or otherwise, after consultation with groups representing hospitals, manufacturers of medical devices, and other affected parties.

(ii)

Establishing criteria for additional categories

(I)

In general

The Secretary shall establish criteria that will be used for creation of additional categories (other than those established under clause (i)) through rulemaking (which may include use of an interim final rule with comment period).

(II)

Standard

Such categories shall be established under this clause in a manner such that no medical device is described by more than one category. Such criteria shall include a test of whether the average cost of devices that would be included in a category and are in use at the time the category is established is not insignificant, as described in subparagraph (A)(iv)(II).

(III)

Deadline

Criteria shall first be established under this clause by . The Secretary may establish in compelling circumstances categories under this clause before the date such criteria are established.

(IV)

Adding categories

The Secretary shall promptly establish a new category of medical devices under this clause for any medical device that meets the requirements of subparagraph (A)(iv) and for which none of the categories in effect (or that were previously in effect) is appropriate.

(iii)

Period for which category is in effect

Subject to subparagraph (K), a category of medical devices established under clause (i) or (ii) shall be in effect for a period of at least 2 years, but not more than 3 years, that begins—
(I)
in the case of a category established under clause (i), on the first date on which payment was made under this paragraph for any device described by such category (including payments made during the period before ); and
(II)
in the case of any other category, on the first date on which payment is made under this paragraph for any medical device that is described by such category.
(iv)

Requirements treated as met

A medical device shall be treated as meeting the requirements of subparagraph (A)(iv), regardless of whether the device meets the requirement of subclause (I) of such subparagraph, if—
(I)
the device is described by a category established and in effect under clause (i); or
(II)
section 360e of title 21section 360(k) of title 21section 360(k) of title 21lsection 360 of title 21section 360j(g) of title 21 the device is described by a category established and in effect under clause (ii) and an application under has been approved with respect to the device, or the device has been cleared for market under , or the device is exempt from the requirements of pursuant to subsection () or (m) of or .
 Nothing in this clause shall be construed as requiring an application or prior approval (other than that described in subclause (II)) in order for a covered device described by a category to qualify for payment under this paragraph.
(C)

Limited period of payment

(i)

Drugs and biologicals

Subject to subparagraph (G), the payment under this paragraph with respect to a drug or biological shall only apply during a period of at least 2 years, but not more than 3 years, that begins—
(I)
on the first date this subsection is implemented in the case of a drug or biological described in clause (i), (ii), or (iii) of subparagraph (A) and in the case of a drug or biological described in subparagraph (A)(iv) and for which payment under this part is made as an outpatient hospital service before such first date; or
(II)
in the case of a drug or biological described in subparagraph (A)(iv) not described in subclause (I), on the first date on which payment is made under this part for the drug or biological as an outpatient hospital service.
(ii)

Medical devices

Payment shall be made under this paragraph with respect to a medical device only if such device—
(I)
is described by a category of medical devices established and in effect under subparagraph (B); and
(II)
is provided as part of a service (or group of services) paid for under this subsection and provided during the period for which such category is in effect under such subparagraph.
(D)

Amount of additional payment

Subject to subparagraph (E)(iii), the amount of the payment under this paragraph with respect to a device, drug, or biological provided as part of a covered OPD service is—
(i)
osection 1395w–3b of this title subject to subparagraph (H), in the case of a drug or biological, the amount by which the amount determined under section 1395u() of this title (or if the drug or biological is covered under a competitive acquisition contract under , an amount determined by the Secretary equal to the average price for the drug or biological for all competitive acquisition areas and year established under such section as calculated and adjusted by the Secretary for purposes of this paragraph) for the drug or biological exceeds the portion of the otherwise applicable medicare OPD fee schedule that the Secretary determines is associated with the drug or biological; or
(ii)
in the case of a medical device, the amount by which the hospital’s charges for the device, adjusted to cost, exceeds the portion of the otherwise applicable medicare OPD fee schedule that the Secretary determines is associated with the device.
(E)

Limit on aggregate annual adjustment

(i)

In general

The total of the additional payments made under this paragraph for covered OPD services furnished in a year (as estimated by the Secretary before the beginning of the year) may not exceed the applicable percentage (specified in clause (ii)) of the total program payments estimated to be made under this subsection for all covered OPD services furnished in that year. If this paragraph is first applied to less than a full year, the previous sentence shall apply only to the portion of such year. This clause shall not apply for 2018 or 2020.

(ii)

Applicable percentage

For purposes of clause (i), the term “applicable percentage” means—
(I)
for a year (or portion of a year) before 2004, 2.5 percent; and
(II)
for 2004 and thereafter, a percentage specified by the Secretary up to (but not to exceed) 2.0 percent.
(iii)

Uniform prospective reduction if aggregate limit projected to be exceeded

If the Secretary estimates before the beginning of a year that the amount of the additional payments under this paragraph for the year (or portion thereof) as determined under clause (i) without regard to this clause will exceed the limit established under such clause, the Secretary shall reduce pro rata the amount of each of the additional payments under this paragraph for that year (or portion thereof) in order to ensure that the aggregate additional payments under this paragraph (as so estimated) do not exceed such limit.

(F)

Limitation of application of functional equivalence standard

(i)

In general

The Secretary may not publish regulations that apply a functional equivalence standard to a drug or biological under this paragraph.

(ii)

Application

Clause (i) shall apply to the application of a functional equivalence standard to a drug or biological on or after , unless—
(I)
such application was being made to such drug or biological prior to ; and
(II)
the Secretary applies such standard to such drug or biological only for the purpose of determining eligibility of such drug or biological for additional payments under this paragraph and not for the purpose of any other payments under this subchapter.
(iii)

Rule of construction

Nothing in this subparagraph shall be construed to effect the Secretary’s authority to deem a particular drug to be identical to another drug if the 2 products are pharmaceutically equivalent and bioequivalent, as determined by the Commissioner of Food and Drugs.

(G)

Pass-through extension for certain drugs and biologicals

In the case of a drug or biological whose period of pass-through status under this paragraph ended on , and for which payment under this subsection was packaged into a payment for a covered OPD service (or group of services) furnished beginning , such pass-through status shall be extended for a 2-year period beginning on .

(H)

Temporary payment rule for certain drugs and biologicals

In the case of a drug or biological whose period of pass-through status under this paragraph ended on , and for which payment under this subsection was packaged into a payment for a covered OPD service (or group of services) furnished beginning , the payment amount for such drug or biological under this subsection that is furnished during the period beginning on , and ending on , shall be the greater of—
(i)
the payment amount that would otherwise apply under subparagraph (D)(i) for such drug or biological during such period; or
(ii)
the payment amount that applied under such subparagraph (D)(i) for such drug or biological on .
(I)

Special payment adjustment rules for last quarter of 2018

15
15 So in original. Probably should be “a covered OPD”.
In the case of a drug or biological whose period of pass-through status under this paragraph ended on , and for which payment under this subsection was packaged into a payment amount for a covered OPD service (or group of services) beginning , the following rules shall apply with respect to payment amounts under this subsection for covered a OPD  service (or group of services) furnished during the period beginning on , and ending on :
(i)
The Secretary shall remove the packaged costs of such drug or biological (as determined by the Secretary) from the payment amount under this subsection for the covered OPD service (or group of services) with which it is packaged.
(ii)
The Secretary shall not make any adjustments to payment amounts under this subsection for a covered OPD service (or group of services) for which no costs were removed under clause (i).
(J)

Additional pass-through extension and special payment adjustment rule for certain diagnostic radiopharmaceuticals

In the case of a drug or biological furnished in the context of a clinical study on diagnostic imaging tests approved under a coverage with evidence development determination whose period of pass-through status under this paragraph concluded on , and for which payment under this subsection was packaged into a payment for a covered OPD service (or group of services) furnished beginning , the Secretary shall—
(i)
extend such pass-through status for such drug or biological for the 9-month period beginning on ;
(ii)
remove, during such period, the packaged costs of such drug or biological (as determined by the Secretary) from the payment amount under this subsection for the covered OPD service (or group of services) with which it is packaged; and
(iii)
not make any adjustments to payment amounts under this subsection for a covered OPD service (or group of services) for which no costs were removed under clause (ii).
(K)

Pass-through extension for certain devices

(i)

In general

In the case of a device whose period of pass-through status under this paragraph will end on , such pass-through status shall be extended for a 1–year period beginning on .

(ii)

No adjustment for packaged costs

For purposes of the 1–year period described in clause (i), the Secretary shall not remove the packaged costs of such device (as determined by the Secretary) from the payment amount under this subsection for a covered OPD service (or group of services) with which it is packaged.

(iii)

No application of aggregate limit or budget neutrality

Notwithstanding any other provision of this subsection, this subparagraph shall not be taken into account—
(I)
in applying the limit on annual aggregate adjustments under subparagraph (E) for 2023; or
(II)
in making any budget neutrality adjustments under this subsection for 2023.
(7)

Transitional adjustment to limit decline in payment

(A)

Before 2002

Subject to subparagraph (D), for covered OPD services furnished before , for which the PPS amount (as defined in subparagraph (E)) is—
(i)
at least 90 percent, but less than 100 percent, of the pre-BBA amount (as defined in subparagraph (F)), the amount of payment under this subsection shall be increased by 80 percent of the amount of such difference;
(ii)
at least 80 percent, but less than 90 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by the amount by which (I) the product of 0.71 and the pre-BBA amount, exceeds (II) the product of 0.70 and the PPS amount;
(iii)
at least 70 percent, but less than 80 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by the amount by which (I) the product of 0.63 and the pre-BBA amount, exceeds (II) the product of 0.60 and the PPS amount; or
(iv)
less than 70 percent of the pre-BBA amount, the amount of payment under this subsection shall be increased by 21 percent of the pre-BBA amount.
(B)

2002

Subject to subparagraph (D), for covered OPD services furnished during 2002, for which the PPS amount is—
(i)
at least 90 percent, but less than 100 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by 70 percent of the amount of such difference;
(ii)
at least 80 percent, but less than 90 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by the amount by which (I) the product of 0.61 and the pre-BBA amount, exceeds (II) the product of 0.60 and the PPS amount; or
(iii)
less than 80 percent of the pre-BBA amount, the amount of payment under this subsection shall be increased by 13 percent of the pre-BBA amount.
(C)

2003

Subject to subparagraph (D), for covered OPD services furnished during 2003, for which the PPS amount is—
(i)
at least 90 percent, but less than 100 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by 60 percent of the amount of such difference; or
(ii)
less than 90 percent of the pre-BBA amount, the amount of payment under this subsection shall be increased by 6 percent of the pre-BBA amount.
(D)

Hold harmless provisions

(i)

Temporary treatment for certain rural hospitals

(I)
section 1395ww(d)(5)(D)(iii) of this title In the case of a hospital located in a rural area and that has not more than 100 beds or a sole community hospital (as defined in ) located in a rural area, for covered OPD services furnished before , for which the PPS amount is less than the pre-BBA amount, the amount of payment under this subsection shall be increased by the amount of such difference.
(II)
section 1395ww(d)(5)(D)(iii) of this title In the case of a hospital located in a rural area and that has not more than 100 beds and that is not a sole community hospital (as defined in ), for covered OPD services furnished on or after , and before , for which the PPS amount is less than the pre-BBA amount, the amount of payment under this subsection shall be increased by the applicable percentage of the amount of such difference. For purposes of the preceding sentence, the applicable percentage shall be 95 percent with respect to covered OPD services furnished in 2006, 90 percent with respect to such services furnished in 2007, and 85 percent with respect to such services furnished in 2008, 2009, 2010, 2011, or 2012.
(III)
section 1395ww(d)(5)(D)(iii) of this title In the case of a sole community hospital (as defined in ) that has not more than 100 beds, for covered OPD services furnished on or after , and before , for which the PPS amount is less than the pre-BBA amount, the amount of payment under this subsection shall be increased by 85 percent of the amount of such difference. In the case of covered OPD services furnished on or after , and before , the preceding sentence shall be applied without regard to the 100-bed limitation.
(ii)

Permanent treatment for cancer hospitals and children’s hospitals

section 1395ww(d)(1)(B) of this titleIn the case of a hospital described in clause (iii) or (v) of , for covered OPD services for which the PPS amount is less than the pre-BBA amount, the amount of payment under this subsection shall be increased by the amount of such difference.

(E)

PPS amount defined

section 1395cc(a)(2)(A)(ii) of this titleIn this paragraph, the term “PPS amount” means, with respect to covered OPD services, the amount payable under this subchapter for such services (determined without regard to this paragraph), including amounts payable as copayment under paragraph (8), coinsurance under , and the deductible under subsection (b).

(F)

Pre-BBA amount defined

(i)

In general

In this paragraph, the “pre-BBA amount” means, with respect to covered OPD services furnished by a hospital in a year, an amount equal to the product of the reasonable cost of the hospital for such services for the portions of the hospital’s cost reporting period (or periods) occurring in the year and the base OPD payment-to-cost ratio for the hospital (as defined in clause (ii)).

(ii)

Base payment-to-cost ratio defined

For purposes of this subparagraph, the “base payment-to-cost ratio” for a hospital means the ratio of—
(I)
the hospital’s reimbursement under this part for covered OPD services furnished during the cost reporting period ending in 1996 (or in the case of a hospital that did not submit a cost report for such period, during the first subsequent cost reporting period ending before 2001 for which the hospital submitted a cost report), including any reimbursement for such services through cost-sharing described in subparagraph (E), to
(II)
the reasonable cost of such services for such period.
 The Secretary shall determine such ratios as if the amendments made by section 4521 of the Balanced Budget Act of 1997 were in effect in 1996.
(G)

Interim payments

The Secretary shall make payments under this paragraph to hospitals on an interim basis, subject to retrospective adjustments based on settled cost reports.

(H)

No effect on copayments

Nothing in this paragraph shall be construed to affect the unadjusted copayment amount described in paragraph (3)(B) or the copayment amount under paragraph (8).

(I)

Application without regard to budget neutrality

The additional payments made under this paragraph—
(i)
shall not be considered an adjustment under paragraph (2)(E); and
(ii)
shall not be implemented in a budget neutral manner.
(8)

Copayment amount

(A)

In general

Except as provided in subparagraphs (B) and (C), the copayment amount under this subsection is the amount by which the amount described in paragraph (4)(B) exceeds the amount of payment determined under paragraph (4)(C).

(B)

Election to offer reduced copayment amount

The Secretary shall establish a procedure under which a hospital, before the beginning of a year (beginning with 1999), may elect to reduce the copayment amount otherwise established under subparagraph (A) for some or all covered OPD services to an amount that is not less than 20 percent of the medicare OPD fee schedule amount (computed under paragraph (3)(D)) for the service involved. Under such procedures, such reduced copayment amount may not be further reduced or increased during the year involved and the hospital may disseminate information on the reduction of copayment amount effected under this subparagraph.

(C)

Limitation on copayment amount

(i)

To inpatient hospital deductible amount

section 1395e(b) of this titleIn no case shall the copayment amount for a procedure performed in a year exceed the amount of the inpatient hospital deductible established under for that year.

(ii)

To specified percentage

The Secretary shall reduce the national unadjusted copayment amount for a covered OPD service (or group of such services) furnished in a year in a manner so that the effective copayment rate (determined on a national unadjusted basis) for that service in the year does not exceed the following percentage:
(I)
For procedures performed in 2001, on or after , 57 percent.
(II)
For procedures performed in 2002 or 2003, 55 percent.
(III)
For procedures performed in 2004, 50 percent.
(IV)
For procedures performed in 2005, 45 percent.
(V)
For procedures performed in 2006 and thereafter, 40 percent.
(D)

No impact on deductibles

Nothing in this paragraph shall be construed as affecting a hospital’s authority to waive the charging of a deductible under subsection (b).

(E)

Computation ignoring outlier and pass-through adjustments

The copayment amount shall be computed under subparagraph (A) as if the adjustments under paragraphs (5) and (6) (and any adjustment made under paragraph (2)(E) in relation to such adjustments) had not occurred.

(F)

Part B rebatable drugs

section 1395w–3a(i) of this titlesection 1395w–3a(i) of this titlesection 1395w–3a(i)(5) of this titlesection 1395w–3a(i)(5) of this titleIn the case of a part B rebatable drug (as defined in paragraph (2) of , except if such drug does not have a copayment amount as a result of application of subparagraph (E)) for which payment under this part is not packaged into a payment for a covered OPD service (or group of services) furnished on or after , and the payment for such drug under this subsection is the same as the amount for a calendar quarter under paragraph (3)(A)(ii)(I) of , under the system under this subsection, in lieu of calculation of the copayment amount and the amount of payment otherwise applicable under this subsection (other than the application of the limitation described in subparagraph (C)), the provisions of and paragraph (1)(EE) of subsection (a), shall, as determined appropriate by the Secretary, apply under this subsection in the same manner as such provisions of and subsection (a) apply under such section and subsection.

(9)

Periodic review and adjustments components of prospective payment system

(A)

Periodic review

The Secretary shall review not less often than annually and revise the groups, the relative payment weights, and the wage and other adjustments described in paragraph (2) to take into account changes in medical practice, changes in technology, the addition of new services, new cost data, and other relevant information and factors. The Secretary shall consult with an expert outside advisory panel composed of an appropriate selection of representatives of providers to review (and advise the Secretary concerning) the clinical integrity of the groups and weights. Such panel may use data collected or developed by entities and organizations (other than the Department of Health and Human Services) in conducting such review.

(B)

Budget neutrality adjustment

If the Secretary makes adjustments under subparagraph (A), then the adjustments for a year may not cause the estimated amount of expenditures under this part for the year to increase or decrease from the estimated amount of expenditures under this part that would have been made if the adjustments had not been made. In determining adjustments under the preceding sentence for 2004 and 2005, the Secretary shall not take into account under this subparagraph or paragraph (2)(E) any expenditures that would not have been made but for the application of paragraph (14).

(C)

Update factor

If the Secretary determines under methodologies described in paragraph (2)(F) that the volume of services paid for under this subsection increased beyond amounts established through those methodologies, the Secretary may appropriately adjust the update to the conversion factor otherwise applicable in a subsequent year.

(10)

Special rule for ambulance services

section 1395x(v)(1)(U) of this titlelThe Secretary shall pay for hospital outpatient services that are ambulance services on the basis described in , or, if applicable, the fee schedule established under section 1395m() of this title.

(11)

Special rules for certain hospitals

section 1395ww(d)(1)(B) of this titleIn the case of hospitals described in clause (iii) or (v) of —
(A)
the system under this subsection shall not apply to covered OPD services furnished before ; and
(B)
the Secretary may establish a separate conversion factor for such services in a manner that specifically takes into account the unique costs incurred by such hospitals by virtue of their patient population and service intensity.
(12)

Limitation on review

section 1395ff of this titleooThere shall be no administrative or judicial review under , 1395 of this title, or otherwise of—
(A)
the development of the classification system under paragraph (2), including the establishment of groups and relative payment weights for covered OPD services, of wage adjustment factors, other adjustments, and methods described in paragraph (2)(F);
(B)
the calculation of base amounts under paragraph (3);
(C)
periodic adjustments made under paragraph (6);
(D)
the establishment of a separate conversion factor under paragraph (8)(B); and
(E)
the determination of the fixed multiple, or a fixed dollar cutoff amount, the marginal cost of care, or applicable percentage under paragraph (5) or the determination of insignificance of cost, the duration of the additional payments, the determination and deletion of initial and new categories (consistent with subparagraphs (B) and (C) of paragraph (6)), the portion of the medicare OPD fee schedule amount associated with particular devices, drugs, or biologicals, and the application of any pro rata reduction under paragraph (6).
(13)

Authorization of adjustment for rural hospitals

(A)

Study

The Secretary shall conduct a study to determine if, under the system under this subsection, costs incurred by hospitals located in rural areas by ambulatory payment classification groups (APCs) exceed those costs incurred by hospitals located in urban areas.

(B)

Authorization of adjustment

Insofar as the Secretary determines under subparagraph (A) that costs incurred by hospitals located in rural areas exceed those costs incurred by hospitals located in urban areas, the Secretary shall provide for an appropriate adjustment under paragraph (2)(E) to reflect those higher costs by .

(14)

Drug APC payment rates

(A)

In general

The amount of payment under this subsection for a specified covered outpatient drug (defined in subparagraph (B)) that is furnished as part of a covered OPD service (or group of services)—
(i)
in 2004, in the case of—
(I)
a sole source drug shall in no case be less than 88 percent, or exceed 95 percent, of the reference average wholesale price for the drug;
(II)
an innovator multiple source drug shall in no case exceed 68 percent of the reference average wholesale price for the drug; or
(III)
a noninnovator multiple source drug shall in no case exceed 46 percent of the reference average wholesale price for the drug;
(ii)
in 2005, in the case of—
(I)
a sole source drug shall in no case be less than 83 percent, or exceed 95 percent, of the reference average wholesale price for the drug;
(II)
an innovator multiple source drug shall in no case exceed 68 percent of the reference average wholesale price for the drug; or
(III)
a noninnovator multiple source drug shall in no case exceed 46 percent of the reference average wholesale price for the drug; or
(iii)
in a subsequent year, shall be equal, subject to subparagraph (E)—
(I)
to the average acquisition cost for the drug for that year (which, at the option of the Secretary, may vary by hospital group (as defined by the Secretary based on volume of covered OPD services or other relevant characteristics)), as determined by the Secretary taking into account the hospital acquisition cost survey data under subparagraph (D); or
(II)
osection 1395w–3a of this titlesection 1395w–3b of this title if hospital acquisition cost data are not available, the average price for the drug in the year established under section 1395u() of this title, , or , as the case may be, as calculated and adjusted by the Secretary as necessary for purposes of this paragraph.
(B)

Specified covered outpatient drug defined

(i)

In general

section 1396r–8(k)(2) of this titleIn this paragraph, the term “specified covered outpatient drug” means, subject to clause (ii), a covered outpatient drug (as defined in ) for which a separate ambulatory payment classification group (APC) has been established and that is—
(I)
a radiopharmaceutical; or
(II)
a drug or biological for which payment was made under paragraph (6) (relating to pass-through payments) on or before .
(ii)

Exception

Such term does not include—
(I)
a drug or biological for which payment is first made on or after , under paragraph (6);
(II)
a drug or biological for which a temporary HCPCS code has not been assigned; or
(III)
during 2004 and 2005, an orphan drug (as designated by the Secretary).
(C)

Payment for designated orphan drugs during 2004 and 2005

The amount of payment under this subsection for an orphan drug designated by the Secretary under subparagraph (B)(ii)(III) that is furnished as part of a covered OPD service (or group of services) during 2004 and 2005 shall equal such amount as the Secretary may specify.

(D)

Acquisition cost survey for hospital outpatient drugs

(i)

Annual GAO surveys in 2004 and 2005

(I)

In general

The Comptroller General of the United States shall conduct a survey in each of 2004 and 2005 to determine the hospital acquisition cost for each specified covered outpatient drug. Not later than , the Comptroller General shall furnish data from such surveys to the Secretary for use in setting the payment rates under subparagraph (A) for 2006.

(II)

Recommendations

Upon the completion of such surveys, the Comptroller General shall recommend to the Secretary the frequency and methodology of subsequent surveys to be conducted by the Secretary under clause (ii).

(ii)

Subsequent secretarial surveys

The Secretary, taking into account such recommendations, shall conduct periodic subsequent surveys to determine the hospital acquisition cost for each specified covered outpatient drug for use in setting the payment rates under subparagraph (A).

(iii)

Survey requirements

The surveys conducted under clauses (i) and (ii) shall have a large sample of hospitals that is sufficient to generate a statistically significant estimate of the average hospital acquisition cost for each specified covered outpatient drug. With respect to the surveys conducted under clause (i), the Comptroller General shall report to Congress on the justification for the size of the sample used in order to assure the validity of such estimates.

(iv)

Differentiation in cost

In conducting surveys under clause (i), the Comptroller General shall determine and report to Congress if there is (and the extent of any) variation in hospital acquisition costs for drugs among hospitals based on the volume of covered OPD services performed by such hospitals or other relevant characteristics of such hospitals (as defined by the Comptroller General).

(v)

Comment on proposed rates

Not later than 30 days after the date the Secretary promulgated proposed rules setting forth the payment rates under subparagraph (A) for 2006, the Comptroller General shall evaluate such proposed rates and submit to Congress a report regarding the appropriateness of such rates based on the surveys the Comptroller General has conducted under clause (i).

(E)

Adjustment in payment rates for overhead costs

(i)

MedPAC report on drug APC design

The Medicare Payment Advisory Commission shall submit to the Secretary, not later than , a report on adjustment of payment for ambulatory payment classifications for specified covered outpatient drugs to take into account overhead and related expenses, such as pharmacy services and handling costs. Such report shall include—
(I)
a description and analysis of the data available with regard to such expenses;
(II)
a recommendation as to whether such a payment adjustment should be made; and
(III)
if such adjustment should be made, a recommendation regarding the methodology for making such an adjustment.
(ii)

Adjustment authorized

The Secretary may adjust the weights for ambulatory payment classifications for specified covered outpatient drugs to take into account the recommendations contained in the report submitted under clause (i).

(F)

Classes of drugs

For purposes of this paragraph:
(i)

Sole source drugs

The term “sole source drug” means—
(I)
section 1395x(t)(1) of this title a biological product (as defined under ); or
(II)
section 1396r–8(k)(7)(A)(iv) of this title a single source drug (as defined in ).
(ii)

Innovator multiple source drugs

section 1396r–8(k)(7)(A)(ii) of this titleThe term “innovator multiple source drug” has the meaning given such term in .

(iii)

Noninnovator multiple source drugs

section 1396r–8(k)(7)(A)(iii) of this titleThe term “noninnovator multiple source drug” has the meaning given such term in .

(G)

Reference average wholesale price

oThe term “reference average wholesale price” means, with respect to a specified covered outpatient drug, the average wholesale price for the drug as determined under section 1395u() of this title as of .

(H)

Inapplicability of expenditures in determining conversion, weighting, and other adjustment factors

Additional expenditures resulting from this paragraph shall not be taken into account in establishing the conversion, weighting, and other adjustment factors for 2004 and 2005 under paragraph (9), but shall be taken into account for subsequent years.

(15)

Payment for new drugs and biologicals until HCPCS code assigned

With respect to payment under this part for an outpatient drug or biological that is covered under this part and is furnished as part of covered OPD services for which a HCPCS code has not been assigned, the amount provided for payment for such drug or biological under this part shall be equal to 95 percent of the average wholesale price for the drug or biological.

(16)

Miscellaneous provisions

(A)

Application of reclassification of certain hospitals

section 1395ww(d)(8)(E) of this titleIf a hospital is being treated as being located in a rural area under , that hospital shall be treated under this subsection as being located in that rural area.

(B)

Threshold for establishment of separate APCS for drugs

The Secretary shall reduce the threshold for the establishment of separate ambulatory payment classification groups (APCs) with respect to drugs or biologicals to $50 per administration for drugs and biologicals furnished in 2005 and 2006.

(C)

Payment for devices of brachytherapy and therapeutic radiopharmaceuticals at charges adjusted to cost

Notwithstanding the preceding provisions of this subsection, for a device of brachytherapy consisting of a seed or seeds (or radioactive source) furnished on or after , and before , and for therapeutic radiopharmaceuticals furnished on or after , and before , the payment basis for the device or therapeutic radiopharmaceutical under this subsection shall be equal to the hospital’s charges for each device or therapeutic radiopharmaceutical furnished, adjusted to cost. Charges for such devices or therapeutic radiopharmaceuticals shall not be included in determining any outlier payment under this subsection.

(D)

Special payment rule

(i)

In general

In the case of covered OPD services furnished on or after , in a hospital described in clause (ii), if—
(I)
the payment rate that would otherwise apply under this subsection for stereotactic radiosurgery, complete course of treatment of cranial lesion(s) consisting of 1 session that is multi-source Cobalt 60 based (identified as of , by HCPCS code 77371 (and any succeeding code) and reimbursed as of such date under APC 0127 (and any succeeding classification group)); exceeds
(II)
the payment rate that would otherwise apply under this subsection for linear accelerator based stereotactic radiosurgery, complete course of therapy in one session (identified as of , by HCPCS code G0173 (and any succeeding code) and reimbursed as of such date under APC 0067 (and any succeeding classification group)),
 the payment rate for the service described in subclause (I) shall be reduced to an amount equal to the payment rate for the service described in subclause (II).
(ii)

Hospital described

A hospital described in this clause is a hospital that is not—
(I)
section 1395ww(d)(2)(D) of this title located in a rural area (as defined in );
(II)
section 1395ww(d)(5)(C) of this title classified as a rural referral center under ; or
(III)
section 1395ww(d)(5)(D)(iii) of this title a sole community hospital (as defined in ).
(iii)

Not budget neutral

In making any budget neutrality adjustments under this subsection for 2013 (with respect to covered OPD services furnished on or after , and before ) or a subsequent year, the Secretary shall not take into account the reduced expenditures that result from the application of this subparagraph.

(E)

Application of appropriate use criteria for certain imaging services

section 1395m(q) of this titleFor provisions relating to the application of appropriate use criteria for certain imaging services, see .

(F)

Payment incentive for the transition from traditional X-ray imaging to digital radiography

Notwithstanding the previous provisions of this subsection:
(i)

Limitation on payment for film X-ray imaging services

In the case of an imaging service that is an X-ray taken using film and that is furnished during 2017 or a subsequent year, the payment amount for such service (including the X-ray component of a packaged service) that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this subsection) for such year shall be reduced by 20 percent.

(ii)

Phased-in limitation on payment for computed radiography imaging services

section 1395w–4(b)(9)(C) of this titleIn the case of an imaging service that is an X-ray taken using computed radiography technology (as defined in )—
(I)
in the case of such a service furnished during 2018, 2019, 2020, 2021, or 2022, the payment amount for such service (including the X-ray component of a packaged service) that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this subsection) for such year shall be reduced by 7 percent; and
(II)
in the case of such a service furnished during 2023 or a subsequent year, the payment amount for such service (including the X-ray component of a packaged service) that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this subsection) for such year shall be reduced by 10 percent.
(iii)

Application without regard to budget neutrality

The reductions made under this subparagraph—
(I)
shall not be considered an adjustment under paragraph (2)(E); and
(II)
shall not be implemented in a budget neutral manner.
(iv)

Implementation

In order to implement this subparagraph, the Secretary shall adopt appropriate mechanisms which may include use of modifiers.

(G)

Temporary additional payments for non-opioid treatments for pain relief

(i)

In general

Notwithstanding any other provision of this subsection, with respect to a non-opioid treatment for pain relief (as defined in clause (iv)) furnished on or after , and before , the Secretary shall not package payment for such non-opioid treatment for pain relief into a payment for a covered OPD service (or group of services), and shall make an additional payment as specified in clause (ii) for such non-opioid treatment for pain relief.

(ii)

Amount of payment

Subject to the limitation under clause (iii), the amount of the payment specified in this clause is, with respect to a non-opioid treatment for pain relief that is—
(I)
section 1395w–3a of this title a drug or biological product, the amount of payment for such drug or biological determined under that exceeds the portion of the otherwise applicable Medicare OPD fee schedule that the Secretary determines is associated with the drug or biological; or
(II)
a medical device, the amount of the hospital’s charges for the device, adjusted to cost, that exceeds the portion of the otherwise applicable Medicare OPD fee schedule that the Secretary determines is associated with the device.
(iii)

Limitation

The additional payment amount specified in clause (ii) shall not exceed the estimated average of 18 percent of the OPD fee schedule amount for the OPD service (or group of services) with which the non-opioid treatment for pain relief is furnished, as determined by the Secretary.

(iv)

Definition of non-opioid treatment for pain relief

In this subparagraph, the term “non-opioid treatment for pain relief” means a drug, biological product, or medical device that—
(I)
in the case of a drug or biological product, has a label indication approved by the Food and Drug Administration to reduce postoperative pain, or produce postsurgical or regional analgesia, without acting upon the body’s opioid receptors;
(II)
in case of a medical device, is used to deliver a therapy to reduce postoperative pain, or produce postsurgical or regional analgesia, and has—
(aa)
section 360e of title 21l an application under that has been approved with respect to the device, been cleared for market under section 360(k) of such title, or is exempt from the requirements of section 360(k) of such title pursuant to subsection () or (m) or section 360 of such title or section 360j(g) of such title; and
(bb)
demonstrated the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal;
(III)
does not receive transitional pass-through payment under paragraph (6); and
(IV)
has payment that is packaged into a payment for a covered OPD service (or group of services).
(17)

Quality reporting

(A)

Reduction in update for failure to report

(i)

In general

section 1395ww(d)(1)(B) of this titleFor purposes of paragraph (3)(C)(iv) for 2009 and each subsequent year, in the case of a subsection (d) hospital (as defined in ) that does not submit, to the Secretary in accordance with this paragraph, data required to be submitted on measures selected under this paragraph with respect to such a year, the OPD fee schedule increase factor under paragraph (3)(C)(iv) for such year shall be reduced by 2.0 percentage points.

(ii)

Non-cumulative application

A reduction under this subparagraph shall apply only with respect to the year involved and the Secretary shall not take into account such reduction in computing the OPD fee schedule increase factor for a subsequent year.

(B)

Form and manner of submission

Each subsection (d) hospital shall submit data on measures selected under this paragraph to the Secretary in a form and manner, and at a time, specified by the Secretary for purposes of this paragraph.

(C)

Development of outpatient measures

(i)

In general

The Secretary shall develop measures that the Secretary determines to be appropriate for the measurement of the quality of care (including medication errors) furnished by hospitals in outpatient settings and that reflect consensus among affected parties and, to the extent feasible and practicable, shall include measures set forth by one or more national consensus building entities.

(ii)

Construction

section 1395ww(b)(3)(B)(viii) of this titleNothing in this paragraph shall be construed as preventing the Secretary from selecting measures that are the same as (or a subset of) the measures for which data are required to be submitted under .

(D)

Replacement of measures

For purposes of this paragraph, the Secretary may replace any measures or indicators in appropriate cases, such as where all hospitals are effectively in compliance or the measures or indicators have been subsequently shown not to represent the best clinical practice.

(E)

Availability of data

The Secretary shall establish procedures for making data submitted under this paragraph available to the public. Such procedures shall ensure that a hospital has the opportunity to review the data that are to be made public with respect to the hospital prior to such data being made public. The Secretary shall report quality measures of process, structure, outcome, patients’ perspectives on care, efficiency, and costs of care that relate to services furnished in outpatient settings in hospitals on the Internet website of the Centers for Medicare & Medicaid Services.

(18)

Authorization of adjustment for cancer hospitals

(A)

Study

section 1395ww(d)(1)(B)(v) of this titleThe Secretary shall conduct a study to determine if, under the system under this subsection, costs incurred by hospitals described in with respect to ambulatory payment classification groups exceed those costs incurred by other hospitals furnishing services under this subsection (as determined appropriate by the Secretary). In conducting the study under this subparagraph, the Secretary shall take into consideration the cost of drugs and biologicals incurred by such hospitals.

(B)

Authorization of adjustment

section 1395ww(d)(1)(B)(v) of this titleInsofar as the Secretary determines under subparagraph (A) that costs incurred by hospitals described in exceed those costs incurred by other hospitals furnishing services under this subsection, the Secretary shall, subject to subparagraph (C), provide for an appropriate adjustment under paragraph (2)(E) to reflect those higher costs effective for services furnished on or after .

(C)

Target PCR adjustment

section 1395ww(d)(1)(B)(v) of this titleIn applying section 419.43(i) of title 42 of the Code of Federal Regulations to implement the appropriate adjustment under this paragraph for services furnished on or after , the Secretary shall use a target PCR that is 1.0 percentage points less than the target PCR that would otherwise apply. In addition to the percentage point reduction under the previous sentence, the Secretary may consider making an additional percentage point reduction to such target PCR that takes into account payment rates for applicable items and services described in paragraph (21)(C) other than for services furnished by hospitals described in . In making any budget neutrality adjustments under this subsection for 2018 or a subsequent year, the Secretary shall not take into account the reduced expenditures that result from the application of this subparagraph.

(19)

Floor on area wage adjustment factor for hospital outpatient department services in frontier States

(A)

In general

section 1395ww(d)(3)(E)(iii)(II) of this titleSubject to subparagraph (B), with respect to covered OPD services furnished on or after , the area wage adjustment factor applicable under the payment system established under this subsection to any hospital outpatient department which is located in a frontier State (as defined in ) may not be less than 1.00. The preceding sentence shall not be applied in a budget neutral manner.

(B)

Limitation

section 1395ww(d)(5)(H) of this titleThis paragraph shall not apply to any hospital outpatient department located in a State that receives a non-labor related share adjustment under .

(20)

Not budget neutral application of reduced expenditures resulting from quality incentives for computed tomography

section 1395m(p) of this title16

16 So in original. Probably should be preceded by “under”.
The Secretary shall not take into account the reduced expenditures that result from the application of in making any budget neutrality adjustments this  subsection.

(21)

Services furnished by an off-campus outpatient department of a provider

(A)

Applicable items and services

For purposes of paragraph (1)(B)(v) and this paragraph, the term “applicable items and services” means items and services other than items and services furnished by a dedicated emergency department (as defined in section 489.24(b) of title 42 of the Code of Federal Regulations).

(B)

Off-campus outpatient department of a provider

(i)

In general

For purposes of paragraph (1)(B)(v) and this paragraph, subject to the subsequent provisions of this subparagraph, the term “off-campus outpatient department of a provider” means a department of a provider (as defined in section 413.65(a)(2) of title 42 of the Code of Federal Regulations, as in effect as of ) that is not located—
(I)
on the campus (as defined in such section 413.65(a)(2)) of such provider; or
(II)
within the distance (described in such definition of campus) from a remote location of a hospital facility (as defined in such section 413.65(a)(2)).
(ii)

Exception

For purposes of paragraph (1)(B)(v) and this paragraph, the term “off-campus outpatient department of a provider” shall not include a department of a provider (as so defined) that was billing under this subsection with respect to covered OPD services furnished prior to .

(iii)

Deemed treatment for 2017

For purposes of applying clause (ii) with respect to applicable items and services furnished during 2017, a department of a provider (as so defined) not described in such clause is deemed to be billing under this subsection with respect to covered OPD services furnished prior to , if the Secretary received from the provider prior to , an attestation (pursuant to section 413.65(b)(3) of title 42 of the Code of Federal Regulations) that such department was a department of a provider (as so defined).

(iv)

Alternative exception beginning with 2018

For purposes of paragraph (1)(B)(v) and this paragraph with respect to applicable items and services furnished during 2018 or a subsequent year, the term “off-campus outpatient department of a provider” also shall not include a department of a provider (as so defined) that is not described in clause (ii) if—
(I)
the Secretary receives from the provider an attestation (pursuant to such section 413.65(b)(3)) not later than (or, if later, 60 days after ), that such department met the requirements of a department of a provider specified in section 413.65 of title 42 of the Code of Federal Regulations;
(II)
section 1395cc(j) of this title the provider includes such department as part of the provider on its enrollment form in accordance with the enrollment process under ; and
(III)
the department met the mid-build requirement of clause (v) and the Secretary receives, not later than 60 days after , from the chief executive officer or chief operating officer of the provider a written certification that the department met such requirement.
(v)

Mid-build requirement described

The mid-build requirement of this clause is, with respect to a department of a provider, that before , the provider had a binding written agreement with an outside unrelated party for the actual construction of such department.

(vi)

Exclusion for certain cancer hospitals

section 1395ww(d)(1)(B)(v) of this titleFor purposes of paragraph (1)(B)(v) and this paragraph with respect to applicable items and services furnished during 2017 or a subsequent year, the term “off-campus outpatient department of a provider” also shall not include a department of a provider (as so defined) that is not described in clause (ii) if the provider is a hospital described in and—
(I)
in the case of a department that met the requirements of section 413.65 of title 42 of the Code of Federal Regulations after , and before , the Secretary receives from the provider an attestation that such department met such requirements not later than 60 days after such date; or
(II)
in the case of a department that meets such requirements after such date, the Secretary receives from the provider an attestation that such department meets such requirements not later than 60 days after the date such requirements are first met with respect to such department.
(vii)

Audit

Not later than , the Secretary shall audit the compliance with requirements of clause (iv) with respect to each department of a provider to which such clause applies. Not later than 2 years after the date the Secretary receives an attestation under clause (vi) relating to compliance of a department of a provider with requirements referred to in such clause, the Secretary shall audit the compliance with such requirements with respect to the department. If the Secretary finds as a result of an audit under this clause that the applicable requirements were not met with respect to such department, the department shall not be excluded from the term “off-campus outpatient department of a provider” under such clause.

(viii)

Implementation

For purposes of implementing clauses (iii) through (vii):
(I)
Notwithstanding any other provision of law, the Secretary may implement such clauses by program instruction or otherwise.
(II)
Subchapter I of chapter 35 of title 44 shall not apply.
(III)
section 1395t of this titlesection 1395t of this title For purposes of carrying out this subparagraph with respect to clauses (iii) and (iv) (and clause (vii) insofar as it relates to clause (iv)), $10,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under , to remain available until . For purposes of carrying out this subparagraph with respect to clause (vi) (and clause (vii) insofar as it relates to such clause), $2,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under , to remain available until expended.
(C)

Availability of payment under other payment systems

Payments for applicable items and services furnished by an off-campus outpatient department of a provider that are described in paragraph (1)(B)(v) shall be made under the applicable payment system under this part (other than under this subsection) if the requirements for such payment are otherwise met.

(D)

Information needed for implementation

section 1395cc(j) of this titleEach hospital shall provide to the Secretary such information as the Secretary determines appropriate to implement this paragraph and paragraph (1)(B)(v) (which may include reporting of information on a hospital claim using a code or modifier and reporting information about off-campus outpatient departments of a provider on the enrollment form described in ).

(E)

Limitations

section 1395ff of this titleooThere shall be no administrative or judicial review under , section 1395 of this title, or otherwise of the following:
(i)
The determination of the applicable items and services under subparagraph (A) and applicable payment systems under subparagraph (C).
(ii)
The determination of whether a department of a provider meets the term described in subparagraph (B).
(iii)
Any information that hospitals are required to report pursuant to subparagraph (D).
(iv)
The determination of an audit under subparagraph (B)(vii).
(22)

Review and revisions of payments for non-opioid alternative treatments

(A)

In general

With respect to payments made under this subsection for covered OPD services (or groups of services), including covered OPD services assigned to a comprehensive ambulatory payment classification, the Secretary—
(i)
shall, as soon as practicable, conduct a review (part of which may include a request for information) of payments for opioids and evidence-based non-opioid alternatives for pain management (including drugs and devices, nerve blocks, surgical injections, and neuromodulation) with a goal of ensuring that there are not financial incentives to use opioids instead of non-opioid alternatives;
(ii)
may, as the Secretary determines appropriate, conduct subsequent reviews of such payments; and
(iii)
shall consider the extent to which revisions under this subsection to such payments (such as the creation of additional groups of covered OPD services to classify separately those procedures that utilize opioids and non-opioid alternatives for pain management) would reduce payment incentives to use opioids instead of non-opioid alternatives for pain management.
(B)

Priority

In conducting the review under clause (i) of subparagraph (A) and considering revisions under clause (iii) of such subparagraph, the Secretary shall focus on covered OPD services (or groups of services) assigned to a comprehensive ambulatory payment classification, ambulatory payment classifications that primarily include surgical services, and other services determined by the Secretary which generally involve treatment for pain management.

(C)

Revisions

If the Secretary identifies revisions to payments pursuant to subparagraph (A)(iii), the Secretary shall, as determined appropriate, begin making such revisions for services furnished on or after . Revisions under the previous sentence shall be treated as adjustments for purposes of application of paragraph (9)(B).

(D)

Rules of construction

Nothing in this paragraph shall be construed to preclude the Secretary—
(i)
from conducting a demonstration before making the revisions described in subparagraph (C); or
(ii)
prior to implementation of this paragraph, from changing payments under this subsection for covered OPD services (or groups of services) which include opioids or non-opioid alternatives for pain management.
(u)

Incentive payments for physician scarcity areas

(1)

In general

In the case of physicians’ services furnished on or after , and before —
(A)
by a primary care physician in a primary care scarcity county (identified under paragraph (4)); or
(B)
by a physician who is not a primary care physician in a specialist care scarcity county (as so identified),
in addition to the amount of payment that would otherwise be made for such services under this part, there also shall be paid an amount equal to 5 percent of the payment amount for the service under this part.
(2)

Determination of ratios of physicians to medicare beneficiaries in area

Based upon available data, the Secretary shall establish for each county or equivalent area in the United States, the following:
(A)

Number of physicians practicing in the area

The number of physicians who furnish physicians’ services in the active practice of medicine or osteopathy in that county or area, other than physicians whose practice is exclusively for the Federal Government, physicians who are retired, or physicians who only provide administrative services. Of such number, the number of such physicians who are—
(i)
primary care physicians; or
(ii)
physicians who are not primary care physicians.
(B)

Number of medicare beneficiaries residing in the area

The number of individuals who are residing in the county and are entitled to benefits under part A or enrolled under this part, or both (in this subsection referred to as “individuals”).

(C)

Determination of ratios

(i)

Primary care ratio

The ratio (in this paragraph referred to as the “primary care ratio”) of the number of primary care physicians (determined under subparagraph (A)(i)), to the number of individuals determined under subparagraph (B).

(ii)

Specialist care ratio

The ratio (in this paragraph referred to as the “specialist care ratio”) of the number of other physicians (determined under subparagraph (A)(ii)), to the number of individuals determined under subparagraph (B).

(3)

Ranking of counties

The Secretary shall rank each such county or area based separately on its primary care ratio and its specialist care ratio.

(4)

Identification of counties

(A)

In general

The Secretary shall identify—
(i)
those counties and areas (in this paragraph referred to as “primary care scarcity counties”) with the lowest primary care ratios that represent, if each such county or area were weighted by the number of individuals determined under paragraph (2)(B), an aggregate total of 20 percent of the total of the individuals determined under such paragraph; and
(ii)
those counties and areas (in this subsection referred to as “specialist care scarcity counties”) with the lowest specialist care ratios that represent, if each such county or area were weighted by the number of individuals determined under paragraph (2)(B), an aggregate total of 20 percent of the total of the individuals determined under such paragraph.
(B)

Periodic revisions

The Secretary shall periodically revise the counties or areas identified in subparagraph (A) (but not less often than once every three years) unless the Secretary determines that there is no new data available on the number of physicians practicing in the county or area or the number of individuals residing in the county or area, as identified in paragraph (2).

(C)

Identification of counties where service is furnished

For purposes of paying the additional amount specified in paragraph (1), if the Secretary uses the 5-digit postal ZIP Code where the service is furnished, the dominant county of the postal ZIP Code (as determined by the United States Postal Service, or otherwise) shall be used to determine whether the postal ZIP Code is in a scarcity county identified in subparagraph (A) or revised in subparagraph (B).

(D)

Special rule

With respect to physicians’ services furnished on or after , and before , for purposes of this subsection, the Secretary shall use the primary care scarcity counties and the specialty care scarcity counties (as identified under the preceding provisions of this paragraph) that the Secretary was using under this subsection with respect to physicians’ services furnished on .

(E)

Judicial review

ooThere shall be no administrative or judicial review under section 1395ff, 1395 of this title, or otherwise, respecting—
(i)
the identification of a county or area;
(ii)
the assignment of a specialty of any physician under this paragraph;
(iii)
the assignment of a physician to a county under paragraph (2); or
(iv)
the assignment of a postal ZIP Code to a county or other area under this subsection.
(5)

Rural census tracts

To the extent feasible, the Secretary shall treat a rural census tract of a metropolitan statistical area (as determined under the most recent modification of the Goldsmith Modification, originally published in the Federal Register on (57 Fed. Reg. 6725)), as an equivalent area for purposes of qualifying as a primary care scarcity county or specialist care scarcity county under this subsection.

(6)

Physician defined

section 1395x(r)(1) of this titleFor purposes of this paragraph, the term “physician” means a physician described in and the term “primary care physician” means a physician who is identified in the available data as a general practitioner, family practice practitioner, general internist, or obstetrician or gynecologist.

(7)

Publication of list of counties; posting on website

section 1395w–4 of this titleWith respect to a year for which a county or area is identified or revised under paragraph (4), the Secretary shall identify such counties or areas as part of the proposed and final rule to implement the physician fee schedule under for the applicable year. The Secretary shall post the list of counties identified or revised under paragraph (4) on the Internet website of the Centers for Medicare & Medicaid Services.

(v)

Increase of FQHC payment limits

section 1395x(aa)(4) of this titleIn the case of services furnished by Federally qualified health centers (as defined in ), the Secretary shall establish payment limits with respect to such services under this part for services furnished—
(1)
in 2010, at the limits otherwise established under this part for such year increased by $5; and
(2)
section 1395u(i)(3) of this title in a subsequent year, at the limits established under this subsection for the previous year increased by the percentage increase in the MEI (as defined in ) for such subsequent year.
(w)

Methods of payment

The Secretary may develop alternative methods of payment for items and services provided under clinical trials and comparative effectiveness studies sponsored or supported by an agency of the Department of Health and Human Services, as determined by the Secretary, to those that would otherwise apply under this section, to the extent such alternative methods are necessary to preserve the scientific validity of such trials or studies, such as in the case where masking the identity of interventions from patients and investigators is necessary to comply with the particular trial or study design.

(x)

Incentive payments for primary care services

(1)

In general

In the case of primary care services furnished on or after , and before , by a primary care practitioner, in addition to the amount of payment that would otherwise be made for such services under this part, there also shall be paid (on a monthly or quarterly basis) an amount equal to 10 percent of the payment amount for the service under this part.

(2)

Definitions

In this subsection:
(A)

Primary care practitioner

The term “primary care practitioner” means an individual—
(i)
who—
(I)
section 1395x(r)(1) of this title is a physician (as described in ) who has a primary specialty designation of family medicine, internal medicine, geriatric medicine, or pediatric medicine; or
(II)
section 1395x(aa)(5) of this title is a nurse practitioner, clinical nurse specialist, or physician assistant (as those terms are defined in ); and
(ii)
for whom primary care services accounted for at least 60 percent of the allowed charges under this part for such physician or practitioner in a prior period as determined appropriate by the Secretary.
(B)

Primary care services

The term “primary care services” means services identified, as of , by the following HCPCS codes (and as subsequently modified by the Secretary):
(i)
99201 through 99215.
(ii)
99304 through 99340.
(iii)
99341 through 99350.
(3)

Coordination with other payments

The amount of the additional payment for a service under this subsection and subsection (m) shall be determined without regard to any additional payment for the service under subsection (m) and this subsection, respectively. The amount of the additional payment for a service under this subsection and subsection (z) shall be determined without regard to any additional payment for the service under subsection (z) and this subsection, respectively.

(4)

Limitation on review

section 1395ff of this titleooThere shall be no administrative or judicial review under , 1395 of this title, or otherwise, respecting the identification of primary care practitioners under this subsection.

(y)

Incentive payments for major surgical procedures furnished in health professional shortage areas

(1)

In general

section 254e(a)(1)(A) of this titleIn the case of major surgical procedures furnished on or after , and before , by a general surgeon in an area that is designated (under ) as a health professional shortage area as identified by the Secretary prior to the beginning of the year involved, in addition to the amount of payment that would otherwise be made for such services under this part, there also shall be paid (on a monthly or quarterly basis) an amount equal to 10 percent of the payment amount for the service under this part.

(2)

Definitions

In this subsection:
(A)

General surgeon

section 1395x(r)(1) of this titlesection 1395cc(j) of this titleIn this subsection, the term “general surgeon” means a physician (as described in ) who has designated CMS specialty code 02–General Surgery as their primary specialty code in the physician’s enrollment under .

(B)

Major surgical procedures

section 1395w–4(b) of this titleThe term “major surgical procedures” means physicians’ services which are surgical procedures for which a 10-day or 90-day global period is used for payment under the fee schedule under .

(3)

Coordination with other payments

The amount of the additional payment for a service under this subsection and subsection (m) shall be determined without regard to any additional payment for the service under subsection (m) and this subsection, respectively. The amount of the additional payment for a service under this subsection and subsection (z) shall be determined without regard to any additional payment for the service under subsection (z) and this subsection, respectively.

(4)

Application

17

17 So in original. Probably should be “paragraphs”.
The provisions of paragraph  (2) and (4) of subsection (m) shall apply to the determination of additional payments under this subsection in the same manner as such provisions apply to the determination of additional payments under subsection (m).

(z)

Incentive payments for participation in eligible alternative payment models

(1)

Payment incentive

(A)

In general

In the case of covered professional services furnished by an eligible professional during a year that is in the period beginning with 2019 and ending with 2026 and for which the professional is a qualifying APM participant with respect to such year, in addition to the amount of payment that would otherwise be made for such covered professional services under this part for such year, there also shall be paid to such professional an amount equal to 5 percent (or, with respect to 2025, 3.5 percent, or, with respect to 2026, 1.88 percent) of the estimated aggregate payment amounts for such covered professional services under this part for the preceding year. For purposes of the previous sentence, the payment amount for the preceding year may be an estimation for the full preceding year based on a period of such preceding year that is less than the full year. The Secretary shall establish policies to implement this subparagraph in cases in which payment for covered professional services furnished by a qualifying APM participant in an alternative payment model—
(i)
is made to an eligible alternative payment entity rather than directly to the qualifying APM participant; or
(ii)
is made on a basis other than a fee-for-service basis (such as payment on a capitated basis).
(B)

Form of payment

Payments under this subsection shall be made in a lump sum, on an annual basis, as soon as practicable.

(C)

Treatment of payment incentive

Payments under this subsection shall not be taken into account for purposes of determining actual expenditures under an alternative payment model and for purposes of determining or rebasing any benchmarks used under the alternative payment model.

(D)

Coordination

The amount of the additional payment under this subsection or subsection (m) shall be determined without regard to any additional payment under subsection (m) and this subsection, respectively. The amount of the additional payment under this subsection or subsection (x) shall be determined without regard to any additional payment under subsection (x) and this subsection, respectively. The amount of the additional payment under this subsection or subsection (y) shall be determined without regard to any additional payment under subsection (y) and this subsection, respectively.

(2)

Qualifying APM participant

For purposes of this subsection, the term “qualifying APM participant” means the following:
(A)

2019 and 2020

With respect to 2019 and 2020, an eligible professional for whom the Secretary determines that at least 25 percent of payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an eligible alternative payment entity.

(B)

2021 through 2026

With respect to each of 2021 through 2026, an eligible professional described in either of the following clauses:
(i)

Medicare payment threshold option

An eligible professional for whom the Secretary determines that at least 50 percent of payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an eligible alternative payment entity.

(ii)

Combination all-payer and medicare payment threshold option

An eligible professional—
(I)
for whom the Secretary determines, with respect to items and services furnished by such professional during the most recent period for which data are available (which may be less than a year), that at least 50 percent of the sum of—
(aa)
payments described in clause (i); and
(bb)
all other payments, regardless of payer (other than payments made by the Secretary of Defense or the Secretary of Veterans Affairs and other than payments made under subchapter XIX in a State in which no medical home or alternative payment model is available under the State program under that subchapter),
  meet the requirement described in clause (iii)(I) with respect to payments described in item (aa) and meet the requirement described in clause (iii)(II) with respect to payments described in item (bb);
(II)
for whom the Secretary determines at least 25 percent of payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an eligible alternative payment entity; and
(III)
who provides to the Secretary such information as is necessary for the Secretary to make a determination under subclause (I), with respect to such professional.
(iii)

Requirement

For purposes of clause (ii)(I)—
(I)
the requirement described in this subclause, with respect to payments described in item (aa) of such clause, is that such payments are made to an eligible alternative payment entity; and
(II)
the requirement described in this subclause, with respect to payments described in item (bb) of such clause, is that such payments are made under arrangements in which—
(aa)
section 1395w–4(q)(2)(B)(i) of this title quality measures comparable to measures under the performance category described in apply;
(bb)
certified EHR technology is used; and
(cc)
the eligible professional participates in an entity that—
(AA)
18
18 So in original. Probably should be “exceed”.
bears more than nominal financial risk if actual aggregate expenditures exceeds  expected aggregate expenditures; or
(BB)
section 1315a(c) of this title with respect to beneficiaries under subchapter XIX, is a medical home that meets criteria comparable to medical homes expanded under .
(C)

Beginning in 2027

With respect to 2027 and each subsequent year, an eligible professional described in either of the following clauses:
(i)

Medicare payment threshold option

An eligible professional for whom the Secretary determines that at least 75 percent of payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an eligible alternative payment entity.

(ii)

Combination all-payer and medicare payment threshold option

An eligible professional—
(I)
for whom the Secretary determines, with respect to items and services furnished by such professional during the most recent period for which data are available (which may be less than a year), that at least 75 percent of the sum of—
(aa)
payments described in clause (i); and
(bb)
all other payments, regardless of payer (other than payments made by the Secretary of Defense or the Secretary of Veterans Affairs and other than payments made under subchapter XIX in a State in which no medical home or alternative payment model is available under the State program under that subchapter),
  meet the requirement described in clause (iii)(I) with respect to payments described in item (aa) and meet the requirement described in clause (iii)(II) with respect to payments described in item (bb);
(II)
for whom the Secretary determines at least 25 percent of payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an eligible alternative payment entity; and
(III)
who provides to the Secretary such information as is necessary for the Secretary to make a determination under subclause (I), with respect to such professional.
(iii)

Requirement

For purposes of clause (ii)(I)—
(I)
the requirement described in this subclause, with respect to payments described in item (aa) of such clause, is that such payments are made to an eligible alternative payment entity; and
(II)
the requirement described in this subclause, with respect to payments described in item (bb) of such clause, is that such payments are made under arrangements in which—
(aa)
section 1395w–4(q)(2)(B)(i) of this title quality measures comparable to measures under the performance category described in apply;
(bb)
certified EHR technology is used; and
(cc)
the eligible professional participates in an entity that—
(AA)
18 bears more than nominal financial risk if actual aggregate expenditures exceeds  expected aggregate expenditures; or
(BB)
section 1315a(c) of this title with respect to beneficiaries under subchapter XIX, is a medical home that meets criteria comparable to medical homes expanded under .
(D)

Use of patient approach

section 1395w–4(q)(1)(C)(iii) of this titleThe Secretary may base the determination of whether an eligible professional is a qualifying APM participant under this subsection and the determination of whether an eligible professional is a partial qualifying APM participant under by using counts of patients in lieu of using payments and using the same or similar percentage criteria (as specified in this subsection and such section, respectively), as the Secretary determines appropriate. With respect to 2023, 2024, 2025, and 2026, the Secretary shall use the same percentage criteria for counts of patients that are used in 2022.

(3)

Additional definitions

In this subsection:
(A)

Covered professional services

section 1395w–4(k)(3)(A) of this titleThe term “covered professional services” has the meaning given that term in .

(B)

Eligible professional

section 1395w–4(k)(3)(B) of this titleThe term “eligible professional” has the meaning given that term in and includes a group that includes such professionals.

(C)

Alternative payment model (APM)

The term “alternative payment model” means, other than for purposes of subparagraphs (B)(ii)(I)(bb) and (C)(ii)(I)(bb) of paragraph (2), any of the following:
(i)
section 1315a of this title A model under (other than a health care innovation award).
(ii)
section 1395jjj of this title The shared savings program under .
(iii)
section 1395cc–3 of this title A demonstration under .
(iv)
A demonstration required by Federal law.
(D)

Eligible alternative payment entity

The term “eligible alternative payment entity” means, with respect to a year, an entity that—
(i)
participates in an alternative payment model that—
(I)
o requires participants in such model to use certified EHR technology (as defined in subsection ()(4)); and
(II)
section 1395w–4(q)(2)(B)(i) of this title provides for payment for covered professional services based on quality measures comparable to measures under the performance category described in ; and
(ii)
(I)
bears financial risk for monetary losses under such alternative payment model that are in excess of a nominal amount; or
(II)
section 1315a(c) of this title is a medical home expanded under .
(4)

Limitation

section 1395ff of this titleoo19
19 So in original. Probably should be preceded by “section”.
There shall be no administrative or judicial review under , 1395  of this title, or otherwise, of the following:
(A)
The determination that an eligible professional is a qualifying APM participant under paragraph (2) and the determination that an entity is an eligible alternative payment entity under paragraph (3)(D).
(B)
The determination of the amount of the 5 percent (or, with respect to 2025, 3.5 percent, or, with respect to 2026, 1.88 percent) payment incentive under paragraph (1)(A), including any estimation as part of such determination.
(aa)

Medical review of spinal subluxation services

(1)

In general

section 1395x(r)(5) of this titleThe Secretary shall implement a process for the medical review (as described in paragraph (2)) of treatment by a chiropractor described in by means of manual manipulation of the spine to correct a subluxation (as described in such section) of an individual who is enrolled under this part and apply such process to such services furnished on or after , focusing on services such as—
(A)
1 services furnished by a such a  chiropractor whose pattern of billing is aberrant compared to peers; and
(B)
services furnished by such a chiropractor who, in a prior period, has a services denial percentage in the 85th percentile or greater, taking into consideration the extent that service denials are overturned on appeal.
(2)

Medical review

(A)

Prior authorization medical review

(i)

In general

section 1395x(r)(5) of this titleSubject to clause (ii), the Secretary shall use prior authorization medical review for services described in paragraph (1) that are furnished to an individual by a chiropractor described in that are part of an episode of treatment that includes more than 12 services. For purposes of the preceding sentence, an episode of treatment shall be determined by the underlying cause that justifies the need for services, such as a diagnosis code.

(ii)

Ending application of prior authorization medical review

The Secretary shall end the application of prior authorization medical review under clause (i) to services described in paragraph (1) by such a chiropractor if the Secretary determines that the chiropractor has a low denial rate under such prior authorization medical review. The Secretary may subsequently reapply prior authorization medical review to such chiropractor if the Secretary determines it to be appropriate and the chiropractor has, in the time period subsequent to the determination by the Secretary of a low denial rate with respect to the chiropractor, furnished such services described in paragraph (1).

(iii)

Early request for prior authorization review permitted

Nothing in this subsection shall be construed to prevent such a chiropractor from requesting prior authorization for services described in paragraph (1) that are to be furnished to an individual before the chiropractor furnishes the twelfth such service to such individual for an episode of treatment.

(B)

Type of review

section 1395x(r)(5) of this titleThe Secretary may use pre-payment review or post-payment review of services described in that are not subject to prior authorization medical review under subparagraph (A).

(C)

Relationship to law enforcement activities

The Secretary may determine that medical review under this subsection does not apply in the case where potential fraud may be involved.

(3)

No payment without prior authorization

With respect to a service described in paragraph (1) for which prior authorization medical review under this subsection applies, the following shall apply:
(A)

Prior authorization determination

section 1395y(a)(1)(A) of this titleThe Secretary shall make a determination, prior to the service being furnished, of whether the service would or would not meet the applicable requirements of .

(B)

Denial of payment

section 1395y(a)(1)(A) of this titleSubject to paragraph (5), no payment may be made under this part for the service unless the Secretary determines pursuant to subparagraph (A) that the service would meet the applicable requirements of such .

(4)

Submission of information

section 1395x(r)(5) of this titleA chiropractor described in may submit the information necessary for medical review by fax, by mail, or by electronic means. The Secretary shall make available the electronic means described in the preceding sentence as soon as practicable.

(5)

Timeliness

If the Secretary does not make a prior authorization determination under paragraph (3)(A) within 14 business days of the date of the receipt of medical documentation needed to make such determination, paragraph (3)(B) shall not apply.

(6)

Application of limitation on beneficiary liability

section 1395pp of this titlesection 1395y(a)(1) of this titleWhere payment may not be made as a result of the application of paragraph (2)(B), shall apply in the same manner as such section applies to a denial that is made by reason of .

(7)

Review by contractors

section 1395kk–1(a)(4)(G) of this titleThe medical review described in paragraph (2) may be conducted by medicare administrative contractors pursuant to or by any other contractor determined appropriate by the Secretary that is not a recovery audit contractor.

(8)

Multiple services

The Secretary shall, where practicable, apply the medical review under this subsection in a manner so as to allow an individual described in paragraph (1) to obtain, at a single time rather than on a service-by-service basis, an authorization in accordance with paragraph (3)(A) for multiple services.

(9)

Construction

With respect to a service described in paragraph (1) that has been affirmed by medical review under this subsection, nothing in this subsection shall be construed to preclude the subsequent denial of a claim for such service that does not meet other applicable requirements under this chapter.

(10)

Implementation

(A)

Authority

The Secretary may implement the provisions of this subsection by interim final rule with comment period.

(B)

Administration

Chapter 35 of title 44 shall not apply to medical review under this subsection.

(bb)

Additional payments for certain rural health clinics with physicians or practitioners receiving data 2000 waivers

(1)

In general

section 1395x(aa)(1) of this titleIn the case of a rural health clinic with respect to which, beginning on or after , rural health clinic services (as defined in ) are furnished for the treatment of opioid use disorder by a physician or practitioner who meets the requirements described in paragraph (3), the Secretary shall, subject to availability of funds under paragraph (4), make a payment (at such time and in such manner as specified by the Secretary) to such rural health clinic after receiving and approving an application described in paragraph (2). Such payment shall be in an amount determined by the Secretary, based on an estimate of the average costs of training for purposes of receiving a waiver described in paragraph (3)(B). Such payment may be made only one time with respect to each such physician or practitioner.

(2)

Application

In order to receive a payment described in paragraph (1), a rural health clinic shall submit to the Secretary an application for such a payment at such time, in such manner, and containing such information as specified by the Secretary. A rural health clinic may apply for such a payment for each physician or practitioner described in paragraph (1) furnishing services described in such paragraph at such clinic.

(3)

Requirements

For purposes of paragraph (1), the requirements described in this paragraph, with respect to a physician or practitioner, are the following:
(A)
The physician or practitioner is employed by or working under contract with a rural health clinic described in paragraph (1) that submits an application under paragraph (2).
(B)
section 812 of title 21 The physician or practitioner first begins prescribing narcotic drugs in schedule III, IV, or V of for the purpose of maintenance or detoxification treatment on or after .
(4)

Funding

For purposes of making payments under this subsection, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $2,000,000, which shall remain available until expended.

(cc)

Specified COVID–19 testing-related services

For purposes of subsection (a)(1)(DD):
(1)

Description

(A)

In general

A specified COVID–19 testing-related service described in this paragraph is a medical visit that—
(i)
is in any of the categories of HCPCS evaluation and management service codes described in subparagraph (B);
(ii)
section 1320b–5(g)(1)(B) of this title is furnished during any portion of the emergency period (as defined in ) (beginning on or after );
(iii)
section 1395w–22(a)(1)(B)(iv)(IV) of this title results in an order for or administration of a clinical diagnostic laboratory test described in ; and
(iv)
relates to the furnishing or administration of such test or to the evaluation of such individual for purposes of determining the need of such individual for such test.
(B)

Categories of HCPCS codes

For purposes of subparagraph (A), the categories of HCPCS evaluation and management services codes are the following:
(i)
Office and other outpatient services.
(ii)
Hospital observation services.
(iii)
Emergency department services.
(iv)
Nursing facility services.
(v)
Domiciliary, rest home, or custodial care services.
(vi)
Home services.
(vii)
Online digital evaluation and management services.
(2)

Specified outpatient payment provision

A specified outpatient payment provision described in this paragraph is any of the following:
(A)
The hospital outpatient prospective payment system under subsection (t).
(B)
section 1395w–4 of this title The physician fee schedule under .
(C)
o The prospective payment system developed under section 1395m() of this title.
(D)
Section 1395m(g) of this title , with respect to an outpatient critical access hospital service.
(E)
The payment basis determined in regulations pursuant to subsection (a)(3) for rural health clinic services.
(dd)

Special coinsurance rule for certain colorectal cancer screening tests

(1)

In general

In the case of a colorectal cancer screening test to which paragraph (1)(Y) of subsection (a) would not apply but for the third sentence of such subsection that is furnished during a year beginning on or after , and before , the amount paid shall be equal to the specified percent (as defined in paragraph (2)) for such year of the lesser of the actual charge for the service or the amount determined under the fee schedule that applies to such test under this part (or, in the case such test is a covered OPD service (as defined in subsection (t)(1)(B)), the amount determined under subsection (t)).

(2)

Specified percent defined

For purposes of paragraph (1), the term “specified percent” means—
(A)
for 2022, 80 percent;
(B)
for 2023 through 2026, 85 percent; and
(C)
for 2027 through 2029, 90 percent.

Aug. 14, 1935, ch. 531Pub. L. 89–97, title I, § 102(a)79 Stat. 302Pub. L. 90–248, title I81 Stat. 848–850Pub. L. 92–603, title II86 Stat. 1377Pub. L. 95–142, § 16(a)91 Stat. 1200Pub. L. 95–210, § 1(b)91 Stat. 1485Pub. L. 95–292, § 4(b)92 Stat. 315Pub. L. 96–473, § 6(j)94 Stat. 2266Pub. L. 96–499, title IX94 Stat. 2626Pub. L. 96–611, § 1(b)(1)94 Stat. 3566Pub. L. 97–35, title XXI95 Stat. 792Pub. L. 97–248, title I96 Stat. 336Pub. L. 98–369, div. B, title III98 Stat. 1064Pub. L. 98–617, § 3(b)(2)98 Stat. 3295Pub. L. 99–272, title IX100 Stat. 188Pub. L. 99–509, title IX100 Stat. 2014Pub. L. 100–203, title IV101 Stat. 1330–85Pub. L. 100–360, title IV, § 411(f)(2)(D)102 Stat. 777Pub. L. 100–360, title I, § 104(d)(7)102 Stat. 699Pub. L. 100–485, title VI, § 608(d)(3)(G)102 Stat. 2414Pub. L. 100–485, title VI, § 608(d)(4)102 Stat. 2414Pub. L. 100–647, title VIII102 Stat. 3802Pub. L. 101–234, title II103 Stat. 1981Pub. L. 101–239, title VI103 Stat. 2143Pub. L. 101–508, title IV104 Stat. 1388–53Pub. L. 101–597, title IV, § 401(c)(2)104 Stat. 3035Pub. L. 103–66, title XIII107 Stat. 584Pub. L. 103–432, title I108 Stat. 4411Pub. L. 105–33, title IV111 Stat. 330Pub. L. 106–113, div. B, § 1000(a)(6) [title II, §§ 201(a)–(e)(1), (f)–(h)(1), (i), (j), 202(a), 204(a),(b), 211(a)(3)(B), 221(a)(1), 224(a), title III, § 321(g)(2), (k)(2), title IV, §§ 401(b)(1), 403(e)(1)]113 Stat. 1536Pub. L. 106–554, § 1(a)(6) [title I, §§ 105(c), 111(a)(1), title II, §§ 201(b)(1), 205(b), 223(c), 224(a), title IV, §§ 401(a), (b)(1), 402(a), (b), 403(a), 405(a), 406(a), 421(a), 430(a), title V, § 531(a)]114 Stat. 2763Pub. L. 108–173, title II, § 237(a)117 Stat. 2212Pub. L. 109–171, title V120 Stat. 40–42Pub. L. 109–432, div. B, title I120 Stat. 2983–2986Pub. L. 110–173, title I121 Stat. 2495Pub. L. 110–275, title I122 Stat. 2497Pub. L. 111–144, § 6124 Stat. 46Pub. L. 111–148, title IIIl124 Stat. 417Pub. L. 111–152, title I, § 1105(e)124 Stat. 1049Pub. L. 111–309, title I124 Stat. 3287Pub. L. 112–78, title III125 Stat. 1284Pub. L. 112–96, title III126 Stat. 186–188Pub. L. 112–240, title VI126 Stat. 2347Pub. L. 113–67, div. B, title I, § 1103127 Stat. 1196Pub. L. 113–93, title I, § 103128 Stat. 1041Pub. L. 114–10, title I, § 101(e)(2)129 Stat. 117Pub. L. 114–74, title VI, § 603129 Stat. 597Pub. L. 114–113, div. O, title V129 Stat. 3019Pub. L. 114–255, div. A, title V, § 5012(c)(1)130 Stat. 1202Pub. L. 115–123, div. E, title II, § 50202132 Stat. 176Pub. L. 115–141, div. S, title XIII, § 1301(a)(1)132 Stat. 1149Pub. L. 115–271, title II, § 2005(c)(1)132 Stat. 3929Pub. L. 116–94, div. N, title I, § 107(a)133 Stat. 3102Pub. L. 116–127, div. F, § 6002(a)134 Stat. 202Pub. L. 116–136, div. A, title III, § 3713(b)134 Stat. 423Pub. L. 116–159, div. C, title V, § 2501(b)(2)134 Stat. 736Pub. L. 116–260, div. CC, title I134 Stat. 2948Pub. L. 117–7, § 2(a)(1)135 Stat. 251Pub. L. 117–169, title I136 Stat. 1869Pub. L. 117–215, title I, § 103(b)(4)(A)136 Stat. 2263Pub. L. 117–328, div. FF, title I, § 1262(b)(5)136 Stat. 5682Pub. L. 118–42, div. G, title I, § 304(a)138 Stat. 415Pub. L. 119–26, § 4(2)(B)(v)139 Stat. 417(, title XVIII, § 1833, as added , , ; amended , §§ 129(c)(7), (8), 131(a), (b), 132(b), 135(c), , , 853; , §§ 204(a), 211(c)(4), 226(c)(2), 233(b), 245(d), 251(a)(2), (3), 279, 299K(a), , , 1384, 1404, 1411, 1424, 1445, 1454, 1464; , , ; , , ; , (c), , ; , , ; , §§ 918(a)(4), 930(h), 932(a)(1), 934(b), (d)(1), (3), 935(a), 942, 943(a), , , 2631, 2634, 2637, 2639, 2641; , (2), , ; , §§ 2106(a), 2133(a), 2134(a), , , 797; , §§ 101(c)(2), 112(a), (b), 117(a)(2), 148(d), , , 340, 355, 394; , §§ 2303(a)–(d), 2305(a)–(d), 2308(b)(2)(B), 2321(b), (d)(4)(A), 2323(b)(1), (2), (4), 2354(b)(5), (7), , , 1069, 1070, 1074, 1084–1086, 1100; , (3), , ; , §§ 9303(a)(1), (b)(1)–(3), 9401(b)–(2)(E), , , 189, 198, 199; , §§ 9320(e)(1), (2), 9337(b), 9339(a)(1), (b)(1), (2), (c)(1), 9343(a), (b), (e)(2), , , 2033, 2036, 2039–2041; , §§ 4042(b)(2)(B), 4043(a), 4045(c)(2)(A), 4049(a)(1), 4055(a), formerly 4054(a), 4062(d)(3), 4063(b), (e)(1), 4064(a), (b)(1), (2), (c)(1), formerly (c), 4066(a), (b), 4067(a), 4068(a), 4070(a), (b)(4), 4072(b), 4073(b), formerly (b)(2), (3), 4077(b)(2), (3), formerly (b)(3), (4), 4084(a), (c)(2), 4085(b)(1), (i)(1)–(3), (21)(D)(i), (22)(B), (23), , , 1330–88, 1330–90, 1330–108 to 1330–115, 1330–117, 1330–118, 1330–120, 1330–121, 1330–129 to 1330–133, as amended , (8)(B)(i), (12)(A), (14), (g)(2)(E), (3)(A)–(C), (E), (F), (h)(3)(B), (4)(B), (C), (7)(C), (D), (F), (i)(3), (4)(C)(i), (ii), (iv), (vi), , , 779, 781, 783, 784, 786–789; , title II, §§ 201(a), 202(b)(1)–(3), 203(c)(1)(A)–(E), 204(d)(1), 205(c), 212(c)(2), title IV, § 411(f)(8)(C), (g)(1)(E), (2)(D), (3)(D), (4)(C), (5), (h)(1)(A), (i)(4)(B), , , 704, 722, 729, 730, 741, 779, 782–785, 789, as amended , , ; , (22)(B), (D), (23)(A), , , 2420, 2421; , §§ 8421(a), 8422(a), , ; , §§ 201(a), 202(a), , ; , §§ 6003(e)(2)(A), (g)(3)(D)(vii), 6102(c)(1), (e)(1), (5), (6)(A), (7), (f)(2), 6111(a), (b)(1), 6113(b)(3), (d), 6116(b)(1), 6131(a)(1), (b), 6133(a), 6204(b), , , 2153, 2184, 2187–2189, 2213, 2214, 2217, 2219, 2221, 2222, 2241; , §§ 4008(m)(2)(C), 4104(b)(1), 4118(f)(2)(D), 4151(c)(1), (2), 4153(a)(2)(B), (C), 4154(a), (b)(1), (c)(1), (e)(1), 4155(b)(2), (3), 4160, 4161(a)(3)(B), 4163(d)(1), 4206(b)(2), 4302, , , 1388–59, 1388–70, 1388–73, 1388–83 to 1388–87, 1388–91, 1388–93, 1388–100, 1388–116, 1388–125; , , ; , §§ 13516(b), 13532(a), 13544(b)(2), 13551, 13555(a), , , 586, 590, 592; , §§ 123(b)(2)(A), (e), 141(a), (c)(1), 147(a), (d), (e)(2), (3), (f)(6)(C), (D), 156(a)(2)(B), 160(d)(1), , , 4412, 4424, 4425, 4429, 4430, 4432, 4440, 4443; , §§ 4002(j)(1)(A), 4101(b), 4102(b), 4103(b), 4104(c)(1), (2), 4201(c)(1), 4205(a)(1)(A), (2), 4315(b), 4432(b)(5)(C), 4511(b), 4512(b)(1), 4521(a), (b), 4523(a), (d)(1)(A)(i), (B)–(3), 4531(b)(1), 4541(a)(1), (c), (d)(1), 4553(a), (b), 4555, 4556(b), 4603(c)(2)(A), , , 360–362, 365, 373, 376, 390, 421, 442–445, 449, 450, 454, 456, 460, 462, 463, 470; , , , 1501A–336 to 1501A–342, 1501A–345, 1501A–348, 1501A–351, 1501A–353, 1501A–366, 1501A–369, 1501A–371; , , , 2763A–472, 2763A–481, 2763A–483, 2763A–489, 2763A–490, 2763A–502, 2763A–503, 2763A–505 to 2763A–508, 2763A–516, 2763A–524, 2763A–547; , title III, §§ 302(b)(2), 303(i)(3)(A), title IV, §§ 411(a)(1), (b), 413(a), (b)(1), title VI, §§ 614(a), (b), 621(a)(1)–(5), (b)(1), (2), 622, 624(a)(1), 626(a)–(c), 627(a), 628, 629, 642(b), title VII, § 736(b)(1), (2), title IX, § 942(b), , , 2229, 2254, 2274, 2275, 2277, 2306–2311, 2317–2322, 2355, 2421; , §§ 5103, 5105, 5107(a)(1), 5112(e), 5113(a), , , 44; , §§ 107(a), (b)(1), 109(a)(1), (b), title II, § 201, , ; , §§ 102, 105, 106, 113, , , 2496, 2501; , §§ 101(a)(2), (b)(2), 102, 141, 142, 143(b)(2), (3), 145(a)(2), (b), 147, 151(a), 184, , , 2498, 2542, 2543, 2547, 2548, 2550, 2587; , , ; , §§ 3103, 3114, 3121, 3138, 3401(i), (k), (), title IV, §§ 4103(c)(1), (3), (4), 4104(b), (c), title V, § 5501(a)(1), (b)(1), title X, §§ 10221(a), (b)(4), 10319(g), 10324(b), 10406, 10501(i)(3)(B), (C), , , 423, 439, 485–487, 555–558, 652, 653, 935, 936, 949, 960, 975, 998, 999; , , ; , §§ 104, 108, , , 3288; , §§ 304, 308, , , 1285; , §§ 3002(a), 3005(a), (b), 3202, , , 193; , §§ 603(a)–(c), 634, , , 2355; , , ; , title II, §§ 216(b)(1), 218(a)(2)(A), (b)(2), , , 1059, 1064, 1069; , (3), title II, § 202(a), (b)(1), title V, § 514(a), , , 122, 143, 171; , , ; , §§ 502(b), 504(b)(1), , , 3021; , div. C, title XVI, §§ 16001(a), 16002(a), (b), , , 1324–1326; , , ; , (2), , , 1150; , title VI, §§ 6082, 6083(b), , , 3992, 3994; , , ; , , ; , , ; , , ; , §§ 114(a), 122(a), (b), 125(a)(2)(A), 130, , , 2955, 2956, 2963, 2973; , , ; , §§ 11101(b), 11407(a), (b), , , 1904; , , ; , title IV, §§ 4111(a), 4121(a)(3), 4124(b)(3), 4133(a)(2)(A), 4134(d), 4135(a), (b), 4141(a), , , 5897, 5903, 5909, 5919, 5921, 5922, 5928; , , ; , , .)

Editorial Notes

References in Text

section 626(d) of Pub. L. 108–173Section 626(d) of Medicare Prescription Drug, Improvement, and Modernization Act of 2003, referred to in subsec. (i)(2)(D)(i), is , which is set out as a note under this section.

lsection 9320(k) of Pub. L. 99–509section 1395k of this titleSection 9320(k) of the Omnibus Budget Reconciliation Act of 1986, as amended by section 6132 of the Omnibus Budget Reconciliation Act of 1989, referred to in subsec. ()(1)(C), is , as amended, which is set out as a note under .

lsection 9320 of Pub. L. 99–509lsection 1395ww of this titleThe amendments made by section 9320 of the Omnibus Budget Reconciliation Act of 1986, referred to in subsec. ()(3)(B), are amendments made by , which amended sections 1395k, 1395, 1395u, 1395x, 1395y, 1395aa, 1395bb, 1395cc, 1395ww, 1396a, and 1396n of this title and provisions set out as a note under .

section 4521 of Pub. L. 105–33111 Stat. 444Section 4521 of The Balanced Budget Act of 1997, referred to in subsec. (t)(7)(F), is , , , which amended this section and enacted provisions set out as a note under this section.

Codification

Pub. L. 111–148, § 10221(a)section 10221(b) of Pub. L. 111–148section 10221(b)(4) of Pub. L. 111–148, enacted into law S. 1790, One Hundred Eleventh Congress, as reported by the Committee on Indian Affairs of the Senate in Dec. 2009, “[e]xcept as provided in” . Section 201(b) of S. 1790 would have amended this section but was stricken out by .

Amendments

Pub. L. 119–26, § 4(2)(B)(v)Pub. L. 117–328, § 1262(b)(5)2025—Subsec. (bb)(3)(B). , amended . See 2022 Amendment note below.

Pub. L. 118–42, § 304(a)(1)2024—Subsec. (z)(1)(A). , substituted “with 2026” for “with 2025” and inserted “, or, with respect to 2026, 1.88 percent” after “3.5 percent” in introductory provisions.

Pub. L. 118–42, § 304(a)(2)(A)Subsec. (z)(2)(B). , substituted “2026” for “2025” in heading and introductory provisions.

Pub. L. 118–42, § 304(a)(2)(B)Subsec. (z)(2)(C). , substituted “2027” for “2026” in heading and introductory provisions.

Pub. L. 118–42, § 304(a)(2)(C)Subsec. (z)(2)(D). , substituted “2025, and 2026” for “and 2025”.

Pub. L. 118–42, § 304(a)(3)Subsec. (z)(4)(B). , inserted “, or, with respect to 2026, 1.88 percent” after “3.5 percent”.

Pub. L. 117–169, § 11407(b)(2)section 1395x(n) of this title2022—Subsec. (a). , inserted at end of concluding provisions “The Secretary shall make such adjustments as may be necessary to the amounts paid as specified under paragraph (1)(S)(ii) for insulin furnished on or after , through an item of durable medical equipment covered under , such that the amount of coinsurance payable by an individual enrolled under this part for a month’s supply of such insulin does not exceed $35.”

Pub. L. 117–169, § 11101(b)(1)(A)Subsec. (a)(1)(G). , inserted “, subject to subsection (i)(9),” after “the amounts paid”.

Pub. L. 117–169, § 11407(b)(1)Subsec. (a)(1)(S). , designated existing provisions as cl. (i), inserted “except as provided in clause (ii),” before “subject to subparagraph (EE),”, and added cl. (ii).

Pub. L. 117–169, § 11101(b)(1)(B), substituted “subject to subparagraph (EE), with respect to” for “with respect to”.

Pub. L. 117–169, § 11101(b)(1)(C)Subsec. (a)(1)(EE). , (D), added subpar. (EE).

Pub. L. 117–328, § 4121(a)(3)Subsec. (a)(1)(FF). , added subpar. (FF).

Pub. L. 117–328, § 4133(a)(2)(A)Subsec. (a)(1)(GG). , added subpar. (GG).

Pub. L. 117–328, § 4134(d)Subsec. (a)(1)(HH). , added subpar. (HH).

Pub. L. 117–169, § 11407(a)Subsec. (b)(13). , added par. (13).

Pub. L. 117–328, § 4124(b)(3)Subsec. (c)(2). , inserted “or intensive outpatient services” after “partial hospitalization services”.

Pub. L. 117–169, § 11101(b)(2)Subsec. (i)(9). , added par. (9).

Pub. L. 117–328, § 4135(b)Subsec. (i)(10). , added par. (10).

Pub. L. 117–328, § 4135(a)(1)Subsec. (t)(2)(E). , inserted “and temporary additional payments for non-opioid treatments for pain relief under paragraph (16)(G),” after “payments under paragraph (6)”.

Pub. L. 117–328, § 4141(a)(1)Subsec. (t)(6)(B)(iii). , substituted “Subject to subparagraph (K), a category” for “A category” in introductory provisions.

Pub. L. 117–328, § 4141(a)(2)Subsec. (t)(6)(K). , added subpar. (K).

Pub. L. 117–169, § 11101(b)(3)Subsec. (t)(8)(F). , added subpar. (F).

Pub. L. 117–328, § 4135(a)(2)Subsec. (t)(16)(G). , added subpar. (G).

Pub. L. 117–328, § 4111(a)(1)Subsec. (z)(1)(A). , substituted “2025” for “2024” and inserted “(or, with respect to 2025, 3.5 percent)” after “5 percent” in introductory provisions.

Pub. L. 117–328, § 4111(a)(2)(A)Subsec. (z)(2)(B). , substituted “2025” for “2024” in heading and introductory provisions.

Pub. L. 117–328, § 4111(a)(2)(B)Subsec. (z)(2)(C). , substituted “2026” for “2025” in heading and introductory provisions.

Pub. L. 117–328, § 4111(a)(2)(C)Subsec. (z)(2)(D). , substituted “2023, 2024, and 2025” for “2023 and 2024”.

Pub. L. 117–328, § 4111(a)(3)Subsec. (z)(4)(B). , inserted “(or, with respect to 2025, 3.5 percent)” after “5 percent”.

Pub. L. 117–328, § 1262(b)(5)Pub. L. 119–26, § 4(2)(B)(v)section 812 of title 21section 823(h) of title 21Subsec. (bb)(3)(B). , as amended by , substituted “first begins prescribing narcotic drugs in schedule III, IV, or V of for the purpose of maintenance or detoxification treatment on or after ” for “first receives a waiver under on or after ”.

Pub. L. 117–215 substituted “823(h)” for “823(g)”.

Pub. L. 117–7, § 2(a)(1)(A)(i)2021—Subsec. (f)(3)(A)(i). , added subcls. (I) and (II) and struck out former subcls. (I) and (II) which read as follows:

“(I) the per visit payment amount applicable to such rural health clinic for rural health clinic services furnished in 2020, increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of 2021; or

“(II) the limit described in paragraph (2)(A); and”.

Pub. L. 117–7, § 2(a)(1)(A)(ii)Subsec. (f)(3)(A)(ii)(I). , substituted “under subclause (I) or (II) of clause (i), as applicable,” for “under clause (i)(I)”.

Pub. L. 117–7, § 2(a)(1)(B)Subsec. (f)(3)(B). , added subpar. (B) and struck out former subpar. (B) which read as follows:

“(B) A rural health clinic described in this subparagraph is a rural health clinic that, as of , was—

“(i) in a hospital with less than 50 beds; and

section 1395cc(j) of this title“(ii) enrolled under .”

Pub. L. 116–260, § 122(a)osection 1395m(0) of this title2020—Subsec. (a). , in concluding provisions, substituted “section 1395m() of this title” for “”, realigned margins, and inserted at end “For services furnished on or after , paragraph (1)(Y) shall apply with respect to a colorectal cancer screening test regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or for the removal of tissue or other matter or other procedure that is furnished in connection with, as a result of, and in the same clinical encounter as the screening test.”

Pub. L. 116–260, § 122(b)(1)Subsec. (a)(1)(Y). , inserted “subject to subsection (dd),” before “with respect to”.

Pub. L. 116–127, § 6002(a)(1)Subsec. (a)(1)(DD). , which directed adding subpar. (DD) before the period at the end of par. (1), was executed by adding it before the semicolon at the end, to reflect the probable intent of Congress.

Pub. L. 116–260, § 125(a)(2)(A)Subsec. (a)(10). , added par. (10).

Pub. L. 116–127, § 6002(a)(2)Subsec. (b)(11). , added par. (11).

Pub. L. 116–136Subsec. (b)(12). added par. (12).

Pub. L. 116–260, § 130(2)Subsec. (f). , (3)(A), (4), designated existing provisions as par. (1), redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, of par. (1), and added pars. (2) and (3).

Pub. L. 116–260, § 130(3)(B)Subsec. (f)(1). , which directed insertion of “prior to ” after “services provided”, was executed by making the insertion after “services provided” the second place appearing, to reflect the probable intent of Congress.

Pub. L. 116–260, § 130(1)Subsec. (f)(2). , inserted “(before )” after “in a subsequent year” and substituted “this paragraph” for “this subsection”.

Pub. L. 116–159section 1320b–5(g)(1)(B) of this titleSubsec. (j). inserted before period at end “(or, in the case of such a determination made with respect to a payment made on or after , and during the emergency period described in under the program described in section 421.214 of title 42, Code of Federal Regulations (or any successor regulation), at a rate of 4 percent)”.

Pub. L. 116–260, § 114(a)(1)Subsec. (z)(2)(B). , substituted “through 2024” for “and 2022” in heading and “each of 2021 through 2024” for “2021 and 2022” in introductory provisions.

Pub. L. 116–260, § 114(a)(2)Subsec. (z)(2)(C). , substituted “2025” for “2023” in heading and introductory provisions.

Pub. L. 116–260, § 114(a)(3)Subsec. (z)(2)(D). , inserted at end “With respect to 2023 and 2024, the Secretary shall use the same percentage criteria for counts of patients that are used in 2022.”

Pub. L. 116–127, § 6002(a)(3)Subsec. (cc). , added subsec. (cc).

Pub. L. 116–260, § 122(b)(2)Subsec. (dd). , added subsec. (dd).

Pub. L. 116–94, § 107(a)(1)2019—Subsec. (t)(6)(E)(i). , substituted “2018 or 2020” for “2018”.

Pub. L. 116–94, § 107(a)(2)Subsec. (t)(6)(J). , added subpar. (J).

Pub. L. 115–271, § 2005(c)(1)2018—Subsec. (a)(1)(CC). , added subpar. (CC).

Pub. L. 115–123, § 50202(1)Subsec. (g)(1). , designated existing provisions as subpar. (A), inserted “The preceding sentence shall not apply to expenses incurred with respect to services furnished after .” after “for purposes of subsections (a) and (b).”, and added subpar. (B).

Pub. L. 115–123, § 50202(2)Subsec. (g)(3). , designated existing provisions as subpar. (A), inserted “The preceding sentence shall not apply to expenses incurred with respect to services furnished after .” after “for purposes of subsections (a) and (b).”, and added subpar. (B).

Pub. L. 115–123, § 50202(3)(A)Subsec. (g)(5)(D). , redesignated subpar. (D) as par. (8) of subsec. (g).

Pub. L. 115–123, § 50202(3)(B)Subsec. (g)(5)(E)(iv). , inserted “, except as such process is applied under paragraph (7)(B)” before period at end.

Pub. L. 115–123, § 50202(4)Subsec. (g)(7). , added par. (7).

Pub. L. 115–123, § 50202(3)(A)Subsec. (g)(8). , redesignated par. (5)(D) as par. (8).

Pub. L. 115–271, § 6082(b)Subsec. (i)(8). , added par. (8).

Pub. L. 115–141, § 1301(a)(1)(A)Subsec. (t)(6)(C)(i). , substituted “Subject to subparagraph (G), the payment” for “The payment” in introductory provisions.

Pub. L. 115–141, § 1301(a)(1)(B)Subsec. (t)(6)(D)(i). , inserted “subject to subparagraph (H),” before “in the case”.

Pub. L. 115–141, § 1301(a)(2)Subsec. (t)(6)(E)(i). , inserted at end “This clause shall not apply for 2018.”

Pub. L. 115–141, § 1301(a)(1)(C)Subsec. (t)(6)(G) to (I). , inserted subpars. (G) to (I).

Pub. L. 115–271, § 6082(a)Subsec. (t)(22). , added par. (22).

Pub. L. 115–271, § 6083(b)(1)Subsecs. (z), (aa). , redesignated subsec. (z), relating to medical review of spinal subluxation services, as (aa).

Pub. L. 115–271, § 6083(b)(2)Subsec. (bb). , added subsec. (bb).

Pub. L. 114–255, § 5012(c)(1)2016—Subsec. (a)(1)(BB). , added subpar. (BB).

Pub. L. 114–255, § 16002(b)(1)Subsec. (t)(18)(B). , inserted “, subject to subparagraph (C),” after “shall”.

Pub. L. 114–255, § 16002(b)(2)Subsec. (t)(18)(C). , added subpar. (C).

Pub. L. 114–255, § 16001(a)(1)(A)Subsec. (t)(21)(B)(i). , substituted “the subsequent provisions of this subparagraph” for “clause (ii)”.

Pub. L. 114–255, § 16001(a)(1)(B)Subsec. (t)(21)(B)(iii) to (v). , added cls. (iii) to (v).

Pub. L. 114–255, § 16002(a)(1)Subsec. (t)(21)(B)(vi). , added cl. (vi).

Pub. L. 114–255, § 16002(a)(2)Subsec. (t)(21)(B)(vii). , inserted after first sentence “Not later than 2 years after the date the Secretary receives an attestation under clause (vi) relating to compliance of a department of a provider with requirements referred to in such clause, the Secretary shall audit the compliance with such requirements with respect to the department.”

Pub. L. 114–255, § 16001(a)(1)(B), added cl. (vii).

Pub. L. 114–255, § 16001(a)(1)(B)Subsec. (t)(21)(B)(viii). , added cl. (viii).

Pub. L. 114–255, § 16002(a)(3)section 1395t of this titleSubsec. (t)(21)(B)(viii)(III). , inserted at end “For purposes of carrying out this subparagraph with respect to clause (vi) (and clause (vii) insofar as it relates to such clause), $2,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under , to remain available until expended.”

Pub. L. 114–255, § 16001(a)(2)Subsec. (t)(21)(E)(iv). , added cl. (iv).

Pub. L. 114–113, § 504(b)(1)2015—Subsec. (a)(1)(AA). , added subpar. (AA).

Pub. L. 114–10, § 202(a)(1)Subsec. (g)(5)(A). , substituted “” for “”.

Pub. L. 114–10, § 202(b)(1)(A)Subsec. (g)(5)(C)(i). , inserted “, subject to subparagraph (E),” after “manual medical review process that”.

Pub. L. 114–10, § 202(b)(1)(B)Subsec. (g)(5)(E). , added subpar. (E).

Pub. L. 114–10, § 202(a)(2)Subsec. (g)(6)(A). , substituted “” for “” and “2012 through 2017” for “2012, 2013, 2014, or the first three months of 2015”.

Pub. L. 114–74, § 603(1)Subsec. (t)(1)(B)(v). , added cl. (v).

Pub. L. 114–113, § 502(b)Subsec. (t)(16)(F). , added subpar. (F).

Pub. L. 114–74, § 603(2)Subsec. (t)(21). , added par. (21).

Pub. L. 114–10, § 101(e)(3)(A)Subsec. (x)(3). , inserted at end “The amount of the additional payment for a service under this subsection and subsection (z) shall be determined without regard to any additional payment for the service under subsection (z) and this subsection, respectively.”

Pub. L. 114–10, § 101(e)(3)(B)Subsec. (y)(3). , inserted at end “The amount of the additional payment for a service under this subsection and subsection (z) shall be determined without regard to any additional payment for the service under subsection (z) and this subsection, respectively.”

Pub. L. 114–10, § 514(a)Subsec. (z). , added subsec. (z) relating to medical review of spinal subluxation services.

Pub. L. 114–10, § 101(e)(2), added subsec. (z) relating to incentive payments for participation in eligible alternative payment models.

Pub. L. 113–93, § 216(b)(1)(A)(i)2014—Subsec. (a)(1)(D)(i). –(iii), designated existing provisions as subcl. (I), substituted “subsection (h)(1) (for tests furnished before )” for “subsection (h)(1)”, and added subcl. (II).

Pub. L. 113–93, § 216(b)(1)(A)(iv)Subsec. (a)(1)(D)(ii). , substituted “for tests furnished before , on the basis” for “on the basis”.

Pub. L. 113–93, § 216(b)(1)(B)(i)Subsec. (a)(2)(D)(i). –(iii), designated existing provisions as subcl. (I), substituted “subsection (h)(1) (for tests furnished before )” for “subsection (h)(1)”, and added subcl. (II).

Pub. L. 113–93, § 216(b)(1)(B)(iv)Subsec. (a)(2)(D)(ii). , substituted “for tests furnished before , on the basis” for “on the basis”.

Pub. L. 113–93, § 216(b)(1)(C)Subsec. (b)(3)(B). , substituted “for tests furnished before , on the basis” for “on the basis”.

Pub. L. 113–93, § 103(1)Subsec. (g)(5)(A). , substituted “” for “”.

Pub. L. 113–93, § 103(2)Subsec. (g)(6)(A). , substituted “” for “” and “2012, 2013, 2014, or the first three months of 2015” for “2012, 2013, or the first three months of 2014”.

Pub. L. 113–93, § 216(b)(1)(D)Subsec. (h)(2)(A)(i). , substituted “and, for tests furnished before , subject to” for “and subject to”.

Pub. L. 113–93, § 216(b)(1)(E)section 1395m–1 of this titleSubsec. (h)(3). , in introductory provisions, substituted “fee schedules (for tests furnished before ) or under (for tests furnished on or after ), subject to subsection (b)(5) of such section” for “fee schedules”.

Pub. L. 113–93, § 216(b)(1)(F)Subsec. (h)(6). , substituted “For tests furnished before , in the case” for “In the case”.

Pub. L. 113–93, § 216(b)(1)(G)section 1395m–1 of this titleSubsec. (h)(7). , substituted “and (4) and ” for “and (4)” and “under this part” for “under this subsection”.

Pub. L. 113–93, § 218(b)(2)Subsec. (t)(16)(E). , added subpar. (E).

Pub. L. 113–93, § 218(a)(2)(A)Subsec. (t)(20). , added par. (20).

Pub. L. 113–67, § 1103(1)2013—Subsec. (g)(5)(A). , substituted “” for “” in first sentence.

Pub. L. 112–240, § 603(a)(1), substituted “” for “” in first sentence.

Pub. L. 112–240, § 603(c)Subsec. (g)(5)(D). , added subpar. (D).

Pub. L. 112–240, § 603(b)Subsec. (g)(6). , designated existing provisions as subpar. (A) and added subpar. (B).

Pub. L. 113–67, § 1103(2)Subsec. (g)(6)(A). , substituted “” for “” and “, 2013, or the first three months of 2014” for “or 2013”.

Pub. L. 112–240, § 603(a)(2), substituted “” for “” and inserted “or 2013” after “during 2012”.

Pub. L. 112–240, § 634Subsec. (t)(16)(D). , added subpar. (D).

Pub. L. 112–96, § 3005(b)(1)2012—Subsec. (g)(1), (3). , substituted “but (except as provided in paragraph (6)) not described in subsection (a)(8)(B)” for “but not described in subsection (a)(8)(B) of this section”.

Pub. L. 112–96, § 3005(a)Subsec. (g)(5). , designated existing provisions as subpar. (A), substituted “” for “”, inserted “and if the requirement of subparagraph (B) is met” after “determined to be medically necessary” and “made in accordance with such requirement” after “receipt of the request”, and added subpars. (B) and (C).

Pub. L. 112–96, § 3005(b)(2)Subsec. (g)(6). , added par. (6).

Pub. L. 112–96, § 3202(1)Subsec. (h)(2)(A)(i). , substituted “clause (v), subparagraph (B), and paragraph (4)” for “paragraph (4)”.

Pub. L. 112–96, § 3202(2)Subsec. (h)(2)(A)(iv). , realigned margins.

Pub. L. 112–96, § 3202(3)Subsec. (h)(2)(A)(v). , added cl. (v).

Pub. L. 112–96, § 3002(a)(1)Subsec. (t)(7)(D)(i)(II). , substituted “” for “” and “or 2012” for “or the first two months of 2012”.

Pub. L. 112–96, § 3002(a)(2)Subsec. (t)(7)(D)(i)(III). , substituted “, for which” for “, for which”.

Pub. L. 112–78, § 3042011—Subsec. (g)(5). , substituted “” for “”.

Pub. L. 112–78, § 308(1)Subsec. (t)(7)(D)(i)(II). , substituted “” for “” and “2011, or the first two months of 2012” for “or 2011”.

Pub. L. 112–78, § 308(2)Subsec. (t)(7)(D)(i)(III). , substituted “2009, and before , for which” for “2009, and before , for which” and “2010, and before , the preceding” for “2010, and before , the preceding”.

Pub. L. 111–148, § 10501(i)(3)(C)(ii)2010—Subsec. (a). , inserted concluding provisions.

Pub. L. 111–148, § 3114Subsec. (a)(1)(K). , inserted “(or 100 percent for services furnished on or after )” after “1992, 65 percent”.

Pub. L. 111–148, § 4103(c)(1)(A)section 1395x(hhh)(1) of this titlesection 1395w–4(j)(3) of this titleSubsec. (a)(1)(N). , inserted “other than personalized prevention plan services (as defined in )” after “(as defined in )”.

Pub. L. 111–148, § 4104(b)(1)Pub. L. 111–148, § 10406Subsec. (a)(1)(T). , as amended by , inserted “(or 100 percent if such services are recommended with a grade of A or B by the United States Preventive Services Task Force for any indication or population and are appropriate for the individual)” after “80 percent”.

Pub. L. 111–148, § 4104(b)(2)Pub. L. 111–148, § 10406Subsec. (a)(1)(W). , as amended by , inserted “(if such subparagraph were applied, by substituting ‘100 percent’ for ‘80 percent’)” after “subparagraph (D)” in cl. (i) and substituted “100 percent” for “80 percent” in cl. (ii).

Pub. L. 111–148, § 4103(c)(1)(B)Subsec. (a)(1)(X). , (C), added subpar. (X).

Pub. L. 111–148, § 4104(b)(3)Pub. L. 111–148, § 10406Subsec. (a)(1)(Y). , (4), as amended by , added subpar. (Y).

Pub. L. 111–148, § 10501(i)(3)(B)Subsec. (a)(1)(Z). , added subpar. (Z).

Pub. L. 111–148, § 4103(c)(3)(B)Pub. L. 105–33, § 4603(c)(2)(A)(iv)Subsec. (a)(2)(F) to (H). , which directed amendment of par. (2) by striking “and” at end of subpar. (F), substituting “; and” for comma at end of subpar. (G)(ii), and adding subpar. (H) after subpar. (G)(ii), was executed as directed despite the presence of concluding provisions following subpar. (G)(ii), which were added as part of subpar. (G) by .

Pub. L. 111–148, § 10501(i)(3)(C)(i)(I)oSubsec. (a)(3)(B)(i). , inserted subcl. (I) designation after “otherwise been provided” and “, or (II) in the case of such services furnished on or after the implementation date of the prospective payment system under section 1395m() of this title, under such section (calculated as if ‘100 percent’ were substituted for ‘80 percent’ in such section) for such services if the individual had not been so enrolled” after “been so enrolled”.

Pub. L. 111–148, § 4104(c)(2)Subsec. (b). , inserted at end “Paragraph (1) of the first sentence of this subsection shall apply with respect to a colorectal cancer screening test regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or for the removal of tissue or other matter or other procedure that is furnished in connection with, as a result of, and in the same clinical encounter as the screening test.”

Pub. L. 111–148, § 4104(c)(1)section 1395x(ddd)(3) of this titlesection 1395x(s)(10)(A) of this titleSubsec. (b)(1). , substituted “preventive services described in subparagraph (A) of that are recommended with a grade of A or B by the United States Preventive Services Task Force for any indication or population and are appropriate for the individual.” for “items and services described in ”.

Pub. L. 111–148, § 4103(c)(4)Subsec. (b)(10). , added par. (10).

Pub. L. 111–309, § 104Subsec. (g)(5). , substituted “and ending on ” for “and ending on ”.

Pub. L. 111–148, § 3103Pub. L. 111–144, which directed substitution of “” for “”, could not be executed because “” did not appear subsequent to amendment by . See note below.

Pub. L. 111–144 substituted “” for “”.

Pub. L. 111–148, § 3401lSubsec. (h)(2)(A)(i). ()(1), inserted “, subject to clause (iv),” after “year) by” and substituted “and 2010” for “through 2013”.

Pub. L. 111–148, § 3401lSubsec. (h)(2)(A)(iv). ()(2), added cl. (iv).

Pub. L. 111–148, § 3401(k)Subsec. (i)(2)(D)(v), (vi). , added cl. (v) and redesignated former cl. (v) as (vi).

Pub. L. 111–148, § 4103(c)(3)(A)section 1395x(hhh)(1) of this titleSubsec. (t)(1)(B)(iv). , substituted “, diagnostic mammography, or personalized prevention plan services (as defined in )” for “and diagnostic mammography”.

Pub. L. 111–148, § 10324(b)(1)Subsec. (t)(2)(D). , substituted “subject to paragraph (19), the Secretary” for “the Secretary”.

Pub. L. 111–148, § 3401(i)(1)Subsec. (t)(3)(C)(iv). , inserted “and subparagraph (F) of this paragraph” after “(17)”.

Pub. L. 111–148, § 3401(i)(2)Subsec. (t)(3)(F). , added subpar. (F).

Pub. L. 111–152, § 1105(e)(3)Subsec. (t)(3)(G). , struck out cl. (i) designation and heading, redesignated subcls. (I) to (V) of former cl. (i) as cls. (i) to (v), respectively, and realigned margins.

Pub. L. 111–148, § 3401(i)(2), added subpar. (G).

Pub. L. 111–148, § 10319(g)(1)Subsec. (t)(3)(G)(i)(I). , struck out “and” at end.

Pub. L. 111–152, § 1105(e)(1)(A)Subsec. (t)(3)(G)(i)(II). , placed subcl. (II), which was directed to be inserted after subcl. (II) by Pub. 111–148, § 10319(g)(3), immediately after subcl. (I) and struck out “and” at end. See Amendment note below.

Pub. L. 111–148, § 10319(g)(3), which directed addition of subcl. (II) “after subclause (II)”, could not be executed. See Amendment note above.

Pub. L. 111–152, § 1105(e)(1)Subsec. (t)(3)(G)(i)(III). , added subcl. (III) and struck out former subcl. (III) which read as follows: “subject to clause (ii), for each of 2014 through 2019, 0.2 percentage point.”

Pub. L. 111–148, § 10319(g)(4), substituted “2014” for “2012”.

Pub. L. 111–148, § 10319(g)(2), redesignated subcl. (II) as (III).

Pub. L. 111–152, § 1105(e)(1)(B)Subsec. (t)(3)(G)(i)(IV), (V). , added subcls. (IV) and (V).

Pub. L. 111–152, § 1105(e)(2)Subsec. (t)(3)(G)(ii). , struck out cl. (ii). Prior to amendment, text read as follows: “Clause (i)(II) shall be applied with respect to any of 2014 through 2019 by substituting ‘0.0 percentage points’ for ‘0.2 percentage point’, if for such year—

“(I) the excess (if any) of—

“(aa) the total percentage of the non-elderly insured population for the preceding year (based on the most recent estimates available from the Director of the Congressional Budget Office before a vote in either House on the Patient Protection and Affordable Care Act that, if determined in the affirmative, would clear such Act for enrollment); over

“(bb) the total percentage of the non-elderly insured population for such preceding year (as estimated by the Secretary); exceeds

“(II) 5 percentage points.”

Pub. L. 111–309, § 108(1)Subsec. (t)(7)(D)(i)(II). , substituted “2012” for “2011” in first sentence and “2010, or 2011” for “or 2010” in second sentence.

Pub. L. 111–148, § 3121(a)(1)(B), substituted “, 2009, or 2010” for “or 2009”.

Pub. L. 111–148, § 3121(a)(1)(A), substituted “2011” for “2010”.

Pub. L. 111–309, § 108(2)Subsec. (t)(7)(D)(i)(III). , which directed substitution of “” for “”, was executed by making the substitution in two places to reflect the probable intent of Congress.

Pub. L. 111–148, § 3121(b), inserted at end “In the case of covered OPD services furnished on or after , and before , the preceding sentence shall be applied without regard to the 100-bed limitation.”

Pub. L. 111–148, § 3121(a)(2), substituted “2009, and before ” for “2009, and before ”.

Pub. L. 111–148Subsec. (t)(18), (19). , §§ 3138, 10324(b)(2), added pars. (18) and (19).

Pub. L. 111–148, § 5501(a)(1)Subsecs. (x), (y). , (b)(1), added subsecs. (x) and (y).

Pub. L. 110–275, § 145(a)(2)section 1395w–3(e) of this title2008—Subsec. (a)(1)(D)(iii). , before comma at end of subpar. (D), struck out cl. (iii), which read “on the basis of a rate established under a demonstration project under , the amount paid shall be equal to 100 percent of such rate”.

Pub. L. 110–275, § 101(a)(2)Subsec. (a)(1)(W). , added subpar. (W).

Pub. L. 110–275, § 143(b)(2)Subsec. (a)(8)(A), (B). , substituted “, outpatient speech-language pathology services,” for “(which includes outpatient speech-language pathology services)” in introductory provisions.

Pub. L. 110–275, § 101(b)(2)Subsec. (b)(9). , added par. (9) at end of first sentence.

Pub. L. 110–275, § 102Subsec. (c). , amended subsec. (c) generally. Prior to amendment, text read as follows: “Notwithstanding any other provision of this part, with respect to expenses incurred in any calendar year in connection with the treatment of mental, psychoneurotic, and personality disorders of an individual who is not an inpatient of a hospital at the time such expenses are incurred, there shall be considered as incurred expenses for purposes of subsections (a) and (b) of this section only 62½ percent of such expenses. For purposes of this subsection, the term ‘treatment’ does not include brief office visits (as defined by the Secretary) for the sole purpose of monitoring or changing drug prescriptions used in the treatment of such disorders or partial hospitalization services that are not directly provided by a physician.”

Pub. L. 110–275, § 143(b)(3)llSubsec. (g)(1). , inserted “and speech-language pathology services of the type described in such section through the application of section 1395x()(2) of this title” after “1395x(p) of this title” and “and speech-language pathology services” after “and physical therapy services”.

Pub. L. 110–275, § 141Subsec. (g)(5). , substituted “” for “”.

Pub. L. 110–275, § 145(b)Subsec. (h)(2)(A)(i). , inserted “minus, for each of the years 2009 through 2013, 0.5 percentage points” after “city average)”.

Pub. L. 110–275, § 147(1)Subsec. (t)(7)(D)(i)(II). , substituted “” for “” and “For purposes of the preceding sentence, the applicable percentage shall be 95 percent with respect to covered OPD services furnished in 2006, 90 percent with respect to such services furnished in 2007, and 85 percent with respect to such services furnished in 2008 or 2009.” for “For purposes of the previous sentence, with respect to covered OPD services furnished during 2006, 2007, or 2008, the applicable percentage shall be 95 percent, 90 percent, and 85 percent, respectively.”

Pub. L. 110–275, § 147(2)Subsec. (t)(7)(D)(i)(III). , added subcl. (III).

Pub. L. 110–275, § 142Subsec. (t)(16)(C). , substituted “” for “” in two places.

Pub. L. 110–275, § 151(a)Subsec. (v). , added subsec. (v).

Pub. L. 110–275, § 184Subsec. (w). , added subsec. (w).

Pub. L. 110–173, § 1052007—Subsec. (g)(5). , substituted “” for “”.

Pub. L. 110–173, § 113Subsec. (h)(9). , added par. (9).

Pub. L. 110–173, § 106Subsec. (t)(16)(C). , in heading, inserted “and therapeutic radiopharmaceuticals” before “at charges”, in first sentence, substituted “” for “” and inserted “and for therapeutic radiopharmaceuticals furnished on or after , and before ,” after “,” and “or therapeutic radiopharmaceutical” after “the device” and after “each device”, and, in second sentence, inserted “or therapeutic radiopharmaceuticals” after “such devices”.

Pub. L. 110–173, § 102(1)Subsec. (u)(1). , substituted “before ” for “before ” in introductory provisions.

Pub. L. 110–173, § 102(2)Subsec. (u)(4)(D), (E). , added subpar. (D) and redesignated former subpar. (D) as (E).

Pub. L. 109–171, § 5112(e)2006—Subsec. (b)(7). , added par. (7) at end of first sentence.

Pub. L. 109–171, § 5113(a)Subsec. (b)(8). , added par. (8) at end of first sentence.

Pub. L. 109–171, § 5107(a)(1)(A)Subsec. (g)(1), (3). , substituted “paragraphs (4) and (5)” for “paragraph (4)”.

Pub. L. 109–432, § 201Subsec. (g)(5). , substituted “the period beginning on , and ending on ,” for “2006”.

Pub. L. 109–171, § 5107(a)(1)(B), added par. (5).

Pub. L. 109–171, § 5103(1)Subsec. (i)(2)(A). , inserted “subject to subparagraph (E),” after “subparagraph (D),”.

Pub. L. 109–171, § 5103(2)Subsec. (i)(2)(D)(ii). , inserted “and taking into account reduced expenditures that would apply if subparagraph (E) were to continue to apply, as estimated by the Secretary” before period at end.

Pub. L. 109–432, § 109(b)(1)Subsec. (i)(2)(D)(iv), (v). , added cl. (iv) and redesignated former cl. (iv) as (v).

Pub. L. 109–171, § 5103(3)Subsec. (i)(2)(E). , added subpar. (E).

Pub. L. 109–432, § 109(b)(2)Subsec. (i)(7). , added par. (7).

Pub. L. 109–432, § 107(b)(1)Subsec. (t)(2)(H). , inserted “and for stranded and non-stranded devices furnished on or after ” before period at end.

Pub. L. 109–432, § 109(a)(1)(A)Subsec. (t)(3)(C)(iv). , inserted “subject to paragraph (17),” after “this subparagraph,”.

Pub. L. 109–171, § 5105Subsec. (t)(7)(D)(i). , designated existing provisions as subcl. (I) and added subcl. (II).

Pub. L. 109–432, § 107(a)Subsec. (t)(16)(C). , substituted “2008” for “2007”.

Pub. L. 109–432, § 109(a)(1)(B)Subsec. (t)(17). , added par. (17).

Pub. L. 108–173, § 302(b)(2)(C)2003—Subsec. (a)(1)(D)(iii). , added cl. (iii).

Pub. L. 108–173, § 626(c)Subsec. (a)(1)(G). , added subpar. (G).

Pub. L. 108–173, § 642(b)section 1395x(zz) of this titleSubsec. (a)(1)(S). , inserted “(including intravenous immune globulin (as defined in ))” after “with respect to drugs and biologicals”.

Pub. L. 108–173, § 303(i)(3)(A)o, inserted “(or, if applicable, under section 1395w–3, 1395w–3a, or 1395w–3b of this title)” after “1395u() of this title”.

Pub. L. 108–173, § 302(b)(2)(A)Subsec. (a)(1)(V). , (B), added subpar. (V).

Pub. L. 108–173, § 614(b)Subsec. (a)(2)(E)(i). , inserted “and, for services furnished on or after , diagnostic mammography” after “screening mammography”.

Pub. L. 108–173, § 237(a)section 1395k(a)(2)(D) of this titlesection 1395x(v)(1)(A) of this titlesection 1395cc(a)(2)(A) of this titlesection 1395x(s)(10)(A) of this titleSubsec. (a)(3). , amended par. (3) generally. Prior to amendment, par. (3) read as follows: “in the case of services described in , the costs which are reasonable and related to the cost of furnishing such services or which are based on such other tests of reasonableness as the Secretary may prescribe in regulations, including those authorized under , less the amount a provider may charge as described in clause (ii) of , but in no case may the payment for such services (other than for items and services described in ) exceed 80 percent of such costs;”.

Pub. L. 108–173, § 629section 1395r(a)(1) of this titleSubsec. (b). , substituted “, $100 for 1991 through 2004, $110 for 2005, and for a subsequent year the amount of such deductible for the previous year increased by the annual percentage increase in the monthly actuarial rate under ending with such subsequent year (rounded to the nearest $1)” for “and $100 for 1991 and subsequent years” before semicolon in first sentence.

Pub. L. 108–173, § 624(a)(1)Subsec. (g)(4). , substituted “2002, 2004, and 2005” for “and 2002”.

Pub. L. 108–173, § 628Subsec. (h)(2)(A)(ii)(IV). , substituted “, 1998 through 2002, and 2004 through 2008” for “and 1998 through 2002”.

Pub. L. 108–173, § 736(b)(1)Subsec. (h)(5)(D). , substituted “clinic,” for “clinic,,”.

Pub. L. 108–173, § 942(b)Subsec. (h)(8). , added par. (8).

Pub. L. 108–173, § 626(b)(1)(A)Subsec. (i)(2)(A). , substituted “For services furnished prior to the implementation of the system described in subparagraph (D), the” for “The” in introductory provisions.

Pub. L. 108–173, § 626(b)(1)(B)Subsec. (i)(2)(A)(i). , struck out “taken not later than , and every 5 years thereafter,” before “of the actual audited costs”.

Pub. L. 108–173, § 626(a)Subsec. (i)(2)(C). , amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: “Notwithstanding the second sentence of subparagraph (A) or the second sentence of subparagraph (B), if the Secretary has not updated amounts established under such subparagraphs with respect to facility services furnished during a fiscal year (beginning with fiscal year 1996), such amounts shall be increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) as estimated by the Secretary for the 12-month period ending with the midpoint of the year involved. In each of the fiscal years 1998 through 2002, the increase under this subparagraph shall be reduced (but not below zero) by 2.0 percentage points.”

Pub. L. 108–173, § 626(b)(2)Subsec. (i)(2)(D). , added subpar. (D).

Pub. L. 108–173, § 413(b)(1)Subsec. (m). , designated existing provisions as par. (1), inserted “in a year” after “In the case of physicians’ services furnished” and “as identified by the Secretary prior to the beginning of such year” after “as a health professional shortage area”, and added pars. (2) to (4).

oPub. L. 108–173, § 627(a)(1)Subsec. ()(1)(B). , substituted “no more than the amount of payment applicable under paragraph (2)” for “no more than the limits established under paragraph (2)”.

oPub. L. 108–173, § 627(a)(2)section 1395m of this titleSubsec. ()(2). , amended par. (2) generally, substituting provisions relating to determination of amount of payments pursuant to for provisions specifying dollar amounts of payments.

Pub. L. 108–173, § 614(a)section 1395x(jj) of this titleSubsec. (t)(1)(B)(iv). , inserted before period at end “and does not include screening mammography (as defined in ) and diagnostic mammography”.

Pub. L. 108–173, § 621(b)(2)Subsec. (t)(2)(H). , which directed the amendment of par. (2) by adding a new subpar. (H) at the end, was executed by adding subpar. (H) after subpar. (G), to reflect the probable intent of Congress.

Pub. L. 108–173, § 736(b)(2)Subsec. (t)(3)(C)(ii). , substituted “clause (iv)” for “clause (iii)”.

Pub. L. 108–173, § 621(a)(3)Subsec. (t)(5)(E). , added subpar. (E).

Pub. L. 108–173, § 621(a)(4)section 1395w–3b of this titleoSubsec. (t)(6)(D)(i). , inserted “(or if the drug or biological is covered under a competitive acquisition contract under , an amount determined by the Secretary equal to the average price for the drug or biological for all competitive acquisition areas and year established under such section as calculated and adjusted by the Secretary for purposes of this paragraph)” after “under section 1395u() of this title”.

Pub. L. 108–173, § 622Subsec. (t)(6)(F). , added subpar. (F).

Pub. L. 108–173, § 411(a)(1)(A)Subsec. (t)(7)(D)(i). , (C), substituted “certain” for “small” in heading and “2006” for “2004” in text.

Pub. L. 108–173, § 411(a)(1)(B)section 1395ww(d)(5)(D)(iii) of this title, inserted “or a sole community hospital (as defined in ) located in a rural area” after “100 beds”.

Pub. L. 108–173, § 621(a)(5)Subsec. (t)(9)(B). , inserted at end “In determining adjustments under the preceding sentence for 2004 and 2005, the Secretary shall not take into account under this subparagraph or paragraph (2)(E) any expenditures that would not have been made but for the application of paragraph (14).”

Pub. L. 108–173, § 411(b)(2)Subsec. (t)(13). , added par. (13). Former par. (13) redesignated (16).

Pub. L. 108–173, § 621(a)(1)Subsec. (t)(14), (15). , added pars. (14) and (15).

Pub. L. 108–173, § 411(b)(1)Subsec. (t)(16). , redesignated par. (13) as (16).

Pub. L. 108–173, § 621(a)(2)Subsec. (t)(16)(B). , added subpar. (B).

Pub. L. 108–173, § 621(b)(1)Subsec. (t)(16)(C). , added subpar. (C).

Pub. L. 108–173, § 413(a)Subsec. (u). , added subsec. (u).

Pub. L. 106–554, § 1(a)(6) [title II, § 201(b)(1)]2000—Subsec. (a)(1)(D)(i). , struck out “or which are furnished on an outpatient basis by a critical access hospital” after “on an assignment-related basis”.

Pub. L. 106–554, § 1(a)(6) [title II, § 205(b)]lsection 1395m(g) of this titleSubsec. (a)(1)(R). , substituted “ambulance services, (i)” for “ambulance service,” and inserted before comma at end “and (ii) with respect to ambulance services described in section 1395m()(8) of this title, the amounts paid shall be the amounts determined under for outpatient critical access hospital services”.

Pub. L. 106–554, § 1(a)(6) [title I, § 105(c)]Subsec. (a)(1)(T). , added subpar. (T).

Pub. L. 106–554, § 1(a)(6) [title II, § 223(c)]Subsec. (a)(1)(U). , added subpar. (U).

Pub. L. 106–554, § 1(a)(6) [title II, § 201(b)(1)]Subsec. (a)(2)(D)(i). , struck out “or which are furnished on an outpatient basis by a critical access hospital” after “on an assignment-related basis”.

Pub. L. 106–554, § 1(a)(6) [title II, § 224(a)]Subsec. (f). , substituted “hospitals” for “rural hospitals” in introductory provisions.

Pub. L. 106–554, § 1(a)(6) [title IV, § 421(a)]Subsec. (g)(4). , substituted “2000, 2001, and 2002.” for “2000 and 2001.”

Pub. L. 106–554, § 1(a)(6) [title V, § 531(a)]Subsec. (h)(4)(B)(viii). , inserted before period at end “(or 100 percent of such median in the case of a clinical diagnostic laboratory test performed on or after , that the Secretary determines is a new test for which no limitation amount has previously been established under this subparagraph)”.

Pub. L. 106–554, § 1(a)(6) [title IV, § 430(a)]Subsec. (t)(2)(G). , added subpar. (G).

Pub. L. 106–554, § 1(a)(6) [title IV, § 401(b)(1)(B)]Subsec. (t)(3)(C)(iii). , added cl. (iii). Former cl. (iii) redesignated (iv).

Pub. L. 106–554, § 1(a)(6) [title IV, § 401(a)], substituted “in each of 2000 and 2002” for “in each of 2000, 2001, and 2002”.

Pub. L. 106–554, § 1(a)(6) [title IV, § 401(b)(1)(A)]Subsec. (t)(3)(C)(iv). , redesignated cl. (iii) as (iv).

Pub. L. 106–554, § 1(a)(6) [title IV, § 406(a)]Subsec. (t)(6)(A)(ii). , inserted “or temperature monitored cryoablation” after “device of brachytherapy”.

Pub. L. 106–554, § 1(a)(6) [title IV, § 402(b)(1)]Subsec. (t)(6)(A)(iv)(II). , substituted “the cost of the drug or biological or the average cost of the category of devices” for “the cost of the device, drug, or biological”.

Pub. L. 106–554, § 1(a)(6) [title IV, § 402(a)(2)]Subsec. (t)(6)(B). , added subpar. (B) and struck out heading and text of former subpar. (B). Text read as follows: “The payment under this paragraph with respect to a medical device, drug, or biological shall only apply during a period of at least 2 years, but not more than 3 years, that begins—

“(i) on the first date this subsection is implemented in the case of a drug, biological, or device described in clause (i), (ii), or (iii) of subparagraph (A) and in the case of a device, drug, or biological described in subparagraph (A)(iv) and for which payment under this part is made as an outpatient hospital service before such first date; or

“(ii) in the case of a device, drug, or biological described in subparagraph (A)(iv) not described in clause (i), on the first date on which payment is made under this part for the device, drug, or biological as an outpatient hospital service.”

Pub. L. 106–554, § 1(a)(6) [title IV, § 402(a)(2)]Subsec. (t)(6)(C). , added subpar. (C). Former subpar. (C) redesignated (D).

Pub. L. 106–554, § 1(a)(6) [title IV, § 402(b)(2)]Subsec. (t)(6)(D). , substituted “subparagraph (E)(iii)” for “subparagraph (D)(iii)” in introductory provisions.

Pub. L. 106–554, § 1(a)(6) [title IV, § 402(a)(1)], redesignated subpar. (C) as (D). Former subpar. (D) redesignated (E).

Pub. L. 106–554, § 1(a)(6) [title IV, § 402(a)(1)]Subsec. (t)(6)(E). , redesignated subpar. (D) as (E).

Pub. L. 106–554, § 1(a)(6) [title IV, § 405(a)]section 1395ww(d)(1)(B) of this titlesection 1395ww(d)(1)(B)(v) of this titleSubsec. (t)(7)(D)(ii). , in heading, inserted “and children’s hospitals” after “cancer hospitals” and in text, substituted “clause (iii) or (v) of ” for “”.

Pub. L. 106–554, § 1(a)(6) [title IV, § 403(a)]Subsec. (t)(7)(F)(ii)(I). , inserted “(or in the case of a hospital that did not submit a cost report for such period, during the first subsequent cost reporting period ending before 2001 for which the hospital submitted a cost report)” after “1996”.

Pub. L. 106–554, § 1(a)(6) [title I, § 111(a)(1)]section 1395e(b) of this titleSubsec. (t)(8)(C). , amended heading and text of subpar. (C) generally. Prior to amendment, text read as follows: “In no case shall the copayment amount for a procedure performed in a year exceed the amount of the inpatient hospital deductible established under for that year.”

Pub. L. 106–554, § 1(a)(6) [title IV, § 405(a)(2)]section 1395ww(d)(1)(B) of this titlesection 1395ww(d)(1)(B)(v) of this titleSubsec. (t)(11). , substituted “clause (iii) or (v) of ” for “” in introductory provisions.

Pub. L. 106–554, § 1(a)(6) [title IV, § 402(b)(3)]Subsec. (t)(12)(E). , substituted “additional payments, the determination and deletion of initial and new categories (consistent with subparagraphs (B) and (C) of paragraph (6))” for “additional payments (consistent with paragraph (6)(B))”.

Pub. L. 106–113, § 1000(a)(6) [title IV, § 403(e)(1)]1999—Subsec. (a)(1)(D)(i). , inserted “or which are furnished on an outpatient basis by a critical access hospital” after “on an assignment-related basis”.

Pub. L. 106–113, § 1000(a)(6) [title III, § 321(k)(2)]Subsec. (a)(1)(O). , substituted a comma for the semicolon at end.

Pub. L. 106–113, § 1000(a)(6) [title IV, § 403(e)(1)]Subsec. (a)(2)(D)(i). , inserted “or which are furnished on an outpatient basis by a critical access hospital” after “on an assignment-related basis”.

Pub. L. 106–113, § 1000(a)(6) [title II, § 221(a)(1)(A)]Subsec. (g)(1), (3). , substituted “Subject to paragraph (4), in the case” for “In the case”.

Pub. L. 106–113, § 1000(a)(6) [title II, § 221(a)(1)(B)]Subsec. (g)(4). , added par. (4).

Pub. L. 106–113, § 1000(a)(6) [title III, § 321(g)(2)]Subsec. (h)(5)(A)(iii). , substituted “, critical access hospital, or skilled nursing facility,” for “or critical access hospital,” and inserted “or skilled nursing facility” before period at end.

Pub. L. 106–113, § 1000(a)(6) [title II, § 224(a)]Subsec. (h)(7). , added par. (7).

lPub. L. 106–113, § 1000(a)(6) [title II, § 211(a)(3)(B)]Subsec. ()(4)(A)(i)(VII). , substituted “1395w–4(d) of this title” for “1395w–4(d)(3) of this title”.

Pub. L. 106–113, § 1000(a)(6) [title II, § 201(e)(1)(A)]Subsec. (t)(1)(B)(ii). , substituted “clause (iv)” for “clause (iii)” and directed the striking out of “but” which was executed by striking out “but” after semicolon at end to reflect the probable intent of Congress.

Pub. L. 106–113, § 1000(a)(6) [title II, § 201(e)(1)(B)]Subsec. (t)(1)(B)(iii), (iv). , added cl. (iii) and redesignated former cl. (iii) as (iv).

Pub. L. 106–113, § 1000(a)(6) [title II, § 201(g)]Subsec. (t)(2). , inserted concluding provisions.

Pub. L. 106–113, § 1000(a)(6) [title II, § 201(e)(1)(C)]Subsec. (t)(2)(B). , inserted “and so that an implantable item is classified to the group that includes the service to which the item relates” before semicolon at end.

Pub. L. 106–113, § 1000(a)(6) [title II, § 201(f)]Subsec. (t)(2)(C). , inserted “(or, at the election of the Secretary, mean)” after “median”.

Pub. L. 106–113, § 1000(a)(6) [title II, § 201(c)]Subsec. (t)(2)(E). , substituted “, in a budget neutral manner, outlier adjustments under paragraph (5) and transitional pass-through payments under paragraph (6) and other adjustments as determined to be necessary to ensure equitable payments, such as” for “other adjustments, in a budget neutral manner, as determined to be necessary to ensure equitable payments, such as outlier adjustments or”.

Pub. L. 106–113, § 1000(a)(6) [title II, § 202(a)(1)]Subsec. (t)(4). , inserted “, subject to paragraph (7),” after “is determined” in introductory provisions.

Pub. L. 106–113, § 1000(a)(6) [title II, § 204(b)]Subsec. (t)(4)(C). , inserted “, plus the amount of any reduction in the copayment amount attributable to paragraph (8)(C)” before period at end.

Pub. L. 106–113, § 1000(a)(6) [title II, § 201(a)(2)]Subsec. (t)(5). , added par. (5). Former par. (5) redesignated (7).

Pub. L. 106–113, § 1000(a)(6) [title II, § 201(b)]Subsec. (t)(6). , added par. (6). Former par. (6) redesignated (8).

Pub. L. 106–113, § 1000(a)(6) [title II, § 202(a)(3)]Subsec. (t)(7). , added par. (7). Former par. (7) redesignated (8).

Pub. L. 106–113, § 1000(a)(6) [title II, § 201(a)(1)], redesignated par. (5) as (7). Former par. (7) redesignated (9).

Pub. L. 106–113, § 1000(a)(6) [title II, § 201(i)]Subsec. (t)(7)(D). , added subpar. (D).

Pub. L. 106–113, § 1000(a)(6) [title II, § 202(a)(2)]Subsec. (t)(8). , redesignated par. (7) as (8). Former par. (8) redesignated (9).

Pub. L. 106–113, § 1000(a)(6) [title II, § 201(a)(1)], redesignated par. (6) as (8). Former par. (8) redesignated (10).

Pub. L. 106–113, § 1000(a)(6) [title II, § 204(a)(1)]Subsec. (t)(8)(A). , substituted “subparagraphs (B) and (C)” for “subparagraph (B)”.

Pub. L. 106–113, § 1000(a)(6) [title II, § 201(h)(1)(B)], inserted at end “The Secretary shall consult with an expert outside advisory panel composed of an appropriate selection of representatives of providers to review (and advise the Secretary concerning) the clinical integrity of the groups and weights. Such panel may use data collected or developed by entities and organizations (other than the Department of Health and Human Services) in conducting such review.”

Pub. L. 106–113, § 1000(a)(6) [title II, § 201(h)(1)(A)], substituted “shall review not less often than annually” for “may periodically review”.

Pub. L. 106–113, § 1000(a)(6) [title II, § 204(a)(2), (3)]Subsec. (t)(8)(C) to (E). , added subpar. (C) and redesignated former subpars. (C) and (D) as (D) and (E), respectively.

Pub. L. 106–113, § 1000(a)(6) [title II, § 202(a)(2)]Subsec. (t)(9). , redesignated par. (8) as (9). Former par. (9) redesignated (10).

Pub. L. 106–113, § 1000(a)(6) [title II, § 201(j)]section 1395x(v)(1)(U) of this title, substituted “” for “the matter in subsection (a)(1) of this section preceding subparagraph (A)”.

Pub. L. 106–113, § 1000(a)(6) [title II, § 201(a)(1)], redesignated par. (7) as (9). Former par. (9) redesignated (11).

Pub. L. 106–113, § 1000(a)(6) [title II, § 202(a)(2)]Subsec. (t)(10). , redesignated par. (9) as (10). Former par. (10) redesignated (11).

Pub. L. 106–113, § 1000(a)(6) [title II, § 201(a)(1)], redesignated par. (8) as (10).

Pub. L. 106–113, § 1000(a)(6) [title II, § 202(a)(2)]Subsec. (t)(11). , redesignated par. (10) as (11). Former par. (11) redesignated (12).

Pub. L. 106–113, § 1000(a)(6) [title II, § 201(a)(1)], redesignated par. (9) as (11).

Pub. L. 106–113, § 1000(a)(6) [title II, § 201(d)]Subsec. (t)(11)(E). , added subpar. (E).

Pub. L. 106–113, § 1000(a)(6) [title II, § 202(a)(2)]Subsec. (t)(12). , redesignated par. (11) as (12).

Pub. L. 106–113, § 1000(a)(6) [title IV, § 401(b)(1)]Subsec. (t)(13). , added par. (13).

Pub. L. 105–33, § 4002(j)(1)(A)1997—Subsec. (a)(1)(A). , inserted “(and either is sponsored by a union or employer, or does not provide, or arrange for the provision of, any inpatient hospital services)” after “prepayment basis”.

Pub. L. 105–33, § 4104(c)section 1395m(d)(1) of this titleSubsec. (a)(1)(D). , inserted “or ” after “subsection (h)(1)”.

Pub. L. 105–33, § 4512(b)(1)section 1395x(s)(2)(K) of this titlesection 1395x(s)(2)(K)(ii) of this titleSubsec. (a)(1)(O). , substituted “” for “” and “services furnished by physician assistants, nurse practitioners, or clinic nurse specialists” for “nurse practitioner or clinical nurse specialist services”.

Pub. L. 105–33, § 4511(b)(1)section 1395x(s)(2)(K)(iii) of this titlesection 1395w–4 of this title, amended subpar. (O) generally. Prior to amendment, subpar. (O) read as follows: “with respect to services described in (relating to nurse practitioner or clinical nurse specialist services provided in a rural area), the amounts paid shall be 80 percent of the lesser of the actual charge or the prevailing charge that would be recognized (or, for services furnished on or after , the fee schedule amount provided under ) if the services had been performed by a physician (subject to the limitation described in subsection (r)(2) of this section),”.

Pub. L. 105–33, § 4315(b)Subsec. (a)(1)(Q). , added subpar. (Q).

Pub. L. 105–33, § 4531(b)(1)Subsec. (a)(1)(R). , added subpar. (R).

Pub. L. 105–33, § 4556(b)Subsec. (a)(1)(S). , added subpar. (S).

Pub. L. 105–33, § 4541(a)(1)(A)Subsec. (a)(2). , inserted “(C),” before “(D)” in introductory provisions.

Pub. L. 105–33, § 4603(c)(2)(A)(i)section 1395x(kk) of this titlesection 1395x(s)(10)(A) of this titleSubsec. (a)(2)(A). , amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: “with respect to home health services (other than a covered osteoporosis drug (as defined in )) and to items and services described in , the lesser of—

section 1395x(v) of this title“(i) the reasonable cost of such services, as determined under , or

“(ii) the customary charges with respect to such services,

section 1395f(b)(2) of this titleor, if such services are furnished by a public provider of services, or by another provider which demonstrates to the satisfaction of the Secretary that a significant portion of its patients are low-income (and requests that payment be made under this provision), free of charge or at nominal charges to the public, the amount determined in accordance with ;”.

Pub. L. 105–33, § 4432(b)(5)(C)section 1395yy(e)(9) of this titleSubsec. (a)(2)(B). , inserted “or ” after “1395ww of this title” in introductory provisions.

Pub. L. 105–33, § 4523(d)(3), inserted “furnished before ,” after “(i)” in cl. (i), inserted “before ,” after “furnished” in cl. (ii), added cl. (iii), and redesignated former cl. (iii) as (iv).

Pub. L. 105–33, § 4104(c)(1)section 1395m(d)(1) of this titleSubsec. (a)(2)(D). , inserted “or ” after “subsection (h)(1)”.

Pub. L. 105–33, § 4523(d)(2)(B)Subsec. (a)(2)(E). , inserted “or, for services or procedures performed on or after , subsection (t)” before semicolon at end.

Pub. L. 105–33, § 4603(c)(2)(A)(ii)Subsec. (a)(2)(G). –(iv), added subpar. (G).

Pub. L. 105–33, § 4541(a)(1)(B)section 1395k(a)(2)(D) of this titlesection 1395k(a)(2) of this titleSubsec. (a)(3). , substituted “” for “subparagraphs (D) and (E) of ”.

Pub. L. 105–33, § 4523(d)(1)(B)Subsec. (a)(4). , inserted “or subsection (t)” before semicolon at end.

Pub. L. 105–33, § 4201(c)(1)Subsec. (a)(6). , substituted “critical access” for “rural primary care”.

Pub. L. 105–33, § 4541(a)(1)(C)Subsec. (a)(8), (9). –(E), added pars. (8) and (9).

Pub. L. 105–33, § 4101(b)Subsec. (b)(5). , added par. (5) at end of first sentence.

Pub. L. 105–33, § 4102(b)Subsec. (b)(6). , added par. (6) at end of first sentence.

Pub. L. 105–33, § 4205(a)(1)(A)Subsec. (f). , substituted “rural health clinics (other than such clinics in rural hospitals with less than 50 beds)” for “independent rural health clinics” in introductory provisions.

Pub. L. 105–33, § 4205(a)(2)Subsec. (f)(1). , inserted “per visit” after “$46”.

Pub. L. 105–33, § 4541(d)(1)Subsec. (g). , substituted “the amount specified in paragraph (2) for the year” for “$900” in two places, redesignated first sentence as par. (1) and last sentence as par. (3), and added par. (2).

Pub. L. 105–33, § 4541(c)section 1395x(p) of this titlesection 1395x(p) of this titlesection 1395x(p) of this titlesection 1395x(g) of this titlesection 1395x(p) of this titlesection 1395x(g) of this title, (d)(1)(A), substituted, in first sentence, “physical therapy services of the type described in , but not described in subsection (a)(8)(B) of this section, and physical therapy services of such type which are furnished by a physician or as incident to physicians’ services” for “services described in the second sentence of ”, and substituted, in last sentence, “occupational therapy services (of the type that are described in (but not described in subsection (a)(8)(B) of this section) through the operation of and of such type which are furnished by a physician or as incident to physicians’ services)” for “outpatient occupational therapy services which are described in the second sentence of through the operation of ”.

Pub. L. 105–33, § 4104(c)(2)section 1395m(d)(1) of this titleSubsec. (h)(1)(A). , substituted “Subject to , the Secretary” for “The Secretary”.

Pub. L. 105–33, § 4103(b)oo, inserted “(including prostate cancer screening tests under section 1395x() of this title consisting of prostate-specific antigen blood tests)” after “laboratory tests”.

Pub. L. 105–33, § 4553(a)Subsec. (h)(2)(A)(ii)(IV). , inserted “and 1998 through 2002” after “1995”.

Pub. L. 105–33, § 4553(b)(2)(A)Subsec. (h)(4)(B)(vii). , inserted “and before ,” after “,”.

Pub. L. 105–33, § 4553(b)(1)Subsec. (h)(4)(B)(viii). , (2)(B), (3), added cl. (viii).

Pub. L. 105–33, § 4201(c)(1)Subsec. (h)(5)(A)(iii). , substituted “critical access” for “rural primary care”.

Pub. L. 105–33, § 4201(c)(1)Subsec. (i)(1)(A). , substituted “critical access” for “rural primary care”.

Pub. L. 105–33, § 4555Subsec. (i)(2)(C). , inserted at end “In each of the fiscal years 1998 through 2002, the increase under this subparagraph shall be reduced (but not below zero) by 2.0 percentage points.”

Pub. L. 105–33, § 4523(d)(1)(A)(i)Subsec. (i)(3)(A). , inserted “before ,” after “furnished” and struck out “in a cost reporting period” after “paragraph (1)(A)”.

Pub. L. 105–33, § 4201(c)(1), substituted “critical access” for “rural primary care”.

Pub. L. 105–33, § 4521(a)section 1395cc(a)(2)(A) of this titleSubsec. (i)(3)(B)(i)(II). , struck out “of 80 percent” before “of the standard overhead amount” and inserted before period at end “, less the amount a provider may charge as described in clause (ii) of ”.

lPub. L. 105–33, § 4201(c)(1)Subsec. ()(5). , substituted “critical access” for “rural primary care” wherever appearing.

Pub. L. 105–33, § 4523(d)(2)(A)Subsec. (n)(1)(A). , inserted “and before ,” after “,” and after “,”.

Pub. L. 105–33, § 4521(b)section 1395cc(a)(2)(A) of this titleSubsec. (n)(1)(B)(i)(II). , struck out “of 80 percent” before “of the prevailing charge” and inserted before period at end “, less the amount a provider may charge as described in clause (ii) of ”.

Pub. L. 105–33, § 4511(b)(2)(A)section 1395x(s)(2)(K)(ii) of this titlesection 1395x(s)(2)(K)(iii) of this titleSubsec. (r)(1). , substituted “ (relating to nurse practitioner or clinical nurse specialist services)” for “ (relating to nurse practitioner or clinical nurse specialist services provided in a rural area)”.

Pub. L. 105–33, § 4201(c)(1), substituted “critical access” for “rural primary care”.

Pub. L. 105–33, § 4511(b)(2)(B)Subsec. (r)(2). , (D), redesignated par. (3) as (2) and struck out former par. (2) which read as follows:

section 1395x(s)(2)(K)(iii) of this titlesection 1395w–4 of this title“(2)(A) For purposes of subsection (a)(1)(O) of this section, the prevailing charge for services described in may not exceed the applicable percentage (as defined in subparagraph (B)) of the prevailing charge (or, for services furnished on or after , the fee schedule amount provided under ) determined for such services performed by physicians who are not specialists.

“(B) In subparagraph (A), the term ‘applicable percentage’ means—

“(i) 75 percent in the case of services performed in a hospital, and

“(ii) 85 percent in the case of other services.”

Pub. L. 105–33, § 4511(b)(2)(C)section 1395x(s)(2)(K)(ii) of this titlesection 1395x(s)(2)(K)(iii) of this titleSubsec. (r)(3). , (D), redesignated par. (3) as (2) and substituted “” for “”.

Pub. L. 105–33, § 4201(c)(1), substituted “critical access” for “rural primary care”.

Pub. L. 105–33, § 4523(a)Subsec. (t). , added subsec. (t).

Pub. L. 103–432, § 156(a)(2)(B)(i)section 1320c–13(c)(2) of this title1994—Subsec. (a)(1)(D)(i). , struck out “, or for tests furnished in connection with obtaining a second opinion required under (or a third opinion, if the second opinion was in disagreement with the first opinion)” after “assignment-related basis”.

Pub. L. 103–432, § 156(a)(2)(B)(ii)section 1320c–13(c)(2) of this titleSubsec. (a)(1)(G). , struck out subpar. (G) which read as follows: “with respect to items and services (other than clinical diagnostic laboratory tests) furnished in connection with obtaining a second opinion required under (or a third opinion, if the second opinion was in disagreement with the first opinion), the amounts paid shall be 100 percent of the reasonable charges for such items and services,”.

Pub. L. 103–432, § 156(a)(2)(B)(iii)section 1320c–13(c)(2) of this titleSubsec. (a)(2)(A). , struck out “, to items and services (other than clinical diagnostic laboratory tests) furnished in connection with obtaining a second opinion required under (or a third opinion, if the second opinion was in disagreement with the first opinion),” before “and to items and services” in introductory provisions.

Pub. L. 103–432, § 147(f)(6)(C)(i)section 1395x(kk) of this title, substituted “health services (other than a covered osteoporosis drug (as defined in ))” for “health services” in introductory provisions.

Pub. L. 103–432, § 156(a)(2)(B)(iv)section 1320c–13(c)(2) of this titlesection 1395cc of this titleSubsec. (a)(2)(D)(i). , substituted “assignment-related basis or” for “assignment-related basis,” and struck out “, or for tests furnished in connection with obtaining a second opinion required under (or a third opinion, if the second opinion was in disagreement with the first opinion)” after “”.

Pub. L. 103–432, § 147(f)(6)(C)(ii)Subsec. (a)(2)(F). –(iv), added subpar. (F).

Pub. L. 103–432, § 156(a)(2)(B)(v)section 1320c–13(c)(2) of this titlesection 1395x(s)(10)(A) of this titleSubsec. (a)(3). , struck out “and for items and services furnished in connection with obtaining a second opinion required under , or a third opinion, if the second opinion was in disagreement with the first opinion)” after “”.

Pub. L. 103–432, § 147(f)(6)(D)section 1395x(kk) of this titleSubsec. (b)(2). , inserted “(other than a covered osteoporosis drug (as defined in ))” after “services”.

Pub. L. 103–432, § 156(a)(2)(B)(vi)section 1320c–13(c)(2) of this titleSubsec. (b)(4), (5). , redesignated par. (5) as (4) and struck out former par. (4) which read as follows: “such deductible shall not apply with respect to items and services furnished in connection with obtaining a second opinion required under (or a third opinion, if the second opinion was in disagreement with the first opinion),”.

Pub. L. 103–432, § 123(e)Subsec. (h)(5)(D). , substituted “paragraph (2) of section 1395u(j)” for “paragraphs (2) and (3) of section 1395u(j)” and inserted at end “Paragraph (4) of such section shall apply in this subparagraph in the same manner as such paragraph applies to such section.”

Pub. L. 103–432, § 141(a)(3)Subsec. (i)(1). , inserted before period at end of last sentence “, in consultation with appropriate trade and professional organizations”.

Pub. L. 103–432, § 141(a)(2)(A)Subsec. (i)(2)(A). , struck out “and may be adjusted by the Secretary, when appropriate,” after “annually thereafter” in last sentence.

Pub. L. 103–432, § 141(a)(1)Subsec. (i)(2)(A)(i). , inserted before comma at end “, as determined in accordance with a survey (based upon a representative sample of procedures and facilities) taken not later than , and every 5 years thereafter, of the actual audited costs incurred by such centers in providing such services”.

Pub. L. 103–432, § 141(a)(2)(A)Subsec. (i)(2)(B). , struck out “and may be adjusted by the Secretary, when appropriate,” after “annually thereafter” in last sentence.

Pub. L. 103–432, § 141(a)(2)(B)Subsec. (i)(2)(C). , added subpar. (C).

Pub. L. 103–432, § 141(c)(1)Subsec. (i)(3)(B)(ii). , in subcls. (I) and (II) substituted “for portions of cost reporting periods” for “for reporting periods” and “and ending on or before ” for “and on or before ”.

lPub. L. 103–432, § 123(b)(2)(A)(i)Subsec. ()(5)(B), (C). , redesignated subpar. (C) as (B) and struck out former subpar. (B) which read as follows:

“(B)(i) Payment for the services of a certified registered nurse anesthetist under this part may be made only on an assignment-related basis, and any such assignment agreed to by a certified registered nurse anesthetist shall be binding upon any other person presenting a claim or request for payment for such services.

section 1320a–7a of this titlesection 1320a–7a(a) of this title“(ii) Except for deductible and coinsurance amounts applicable under this section, any person who knowingly and willfully presents, or causes to be presented, to an individual enrolled under this part a bill or request for payment for services of a certified registered nurse anesthetist for which payment may be made under this part only on an assignment-related basis is subject to a civil money penalty of not to exceed $2,000 for each such bill or request. The provisions of (other than subsections (a) and (b)) shall apply to a civil money penalty under the previous sentence in the same manner as such provisions apply to a penalty or proceeding under .”

Pub. L. 103–432, § 147(d)(2)Subsec. (n)(1)(B)(i)(II). , substituted “” for “”.

Pub. L. 103–432, § 147(d)(1)section 1395w–4 of this title, inserted “and for services described in subsection (a)(2)(E)(ii) furnished on or after ” after “” and “(or, in the case of services furnished on or after , under )” before period at end.

Pub. L. 103–432, § 123(b)(2)(A)(ii)section 1395x(s)(2)(L) of this titlesection 1395x(s)(2)(M) of this titlesection 1395x(s)(2)(N) of this titlesection 1320a–7a of this titlesection 1320a–7a(a) of this titleSubsec. (p). , struck out subsec. (p) which read as follows: “In the case of certified nurse-midwife services for which payment may be made under this part only pursuant to , in the case of qualified psychologists services for which payment may be made under this part only pursuant to , and in the case of clinical social worker services for which payment may be made under this part only pursuant to , payment may only be made under this part for such services on an assignment-related basis. Except for deductible and coinsurance amounts applicable under this section, whoever knowingly and willfully presents, or causes to be presented, to an individual enrolled under this part a bill or request for payment for services described in the previous sentence, is subject to a civil money penalty of not to exceed $2,000 for each such bill or request. The provisions of (other than subsections (a) and (b)) shall apply to a civil money penalty under the previous sentence in the same manner as such provisions apply to a penalty or proceeding under .”

Pub. L. 103–432, § 147(a)section 1395nn(h)(5) of this titleSubsec. (q)(1). , substituted “unique physician identification number” for “provider number” and struck out “and indicate whether or not the referring physician is an interested investor (within the meaning of )” after “for the referring physician”.

Pub. L. 103–432, § 160(d)(1)Subsec. (r). , redesignated subsec. (r), relating to other prepaid organizations, as (s).

Pub. L. 103–432, § 147(e)(2)Subsec. (r)(1). , substituted “or ambulatory” for “ambulatory” in two places and “center” for “center,” before “with which the nurse”.

Pub. L. 103–432, § 147(e)(3)Subsec. (r)(2)(A). , substituted “subsection (a)(1)(O) of this section” for “subsection (a)(1)(M) of this section”.

Pub. L. 103–432, § 123(b)(2)(A)(iii)Subsec. (r)(3), (4). , redesignated par. (4) as (3) and struck out former par. (3) which read as follows:

section 1395x(s)(2)(K)(iii) of this title“(3)(A) Payment under this part for services described in may be made only on an assignment-related basis, and any such assignment agreed to by a nurse practitioner or clinical nurse specialist shall be binding upon any other person presenting a claim or request for payment for such services.

section 1395x(s)(2)(K)(iii) of this titlesection 1320a–7a of this titlesection 1320a–7a(a) of this title“(B) Except for deductible and coinsurance amounts applicable under this section, any person who knowingly and willfully presents, or causes to be presented, to an individual enrolled under this part a bill or request for payment for services described in in violation of subparagraph (A) is subject to a civil money penalty of not to exceed $2,000 for each such bill or request. The provisions of (other than subsections (a) and (b)) shall apply to a civil money penalty under the previous sentence in the same manner as such provisions apply to a penalty or proceeding under .”

Pub. L. 103–432, § 160(d)(1)Subsec. (s). , redesignated subsec. (r), relating to other prepaid organizations, as (s).

Pub. L. 103–66, § 13544(b)(2)1993—Subsec. (a)(1). , redesignated subpar. (M) relating to nurse practitioner and clinical nurse specialist services as (O), inserted comma before “(O)”, transferred and inserted such subpar. to appear before semicolon at end, struck out “and” before “(N)”, and inserted “, and” and subpar. (P) following subpar. (O) and before semicolon at end.

Pub. L. 103–66, § 13555(a)Subsec. (g). , substituted “$900” for “$750” in two places.

Pub. L. 103–66, § 13551(a)Subsec. (h)(2)(A)(ii)(IV). , added subcl. (IV).

Pub. L. 103–66, § 13551(b)Subsec. (h)(4)(B)(iv) to (vii). , added cls. (iv) to (vii), and struck out former cl. (iv) which read as follows: “after , is equal to 88 percent of the median of all the fee schedules established for that test for that laboratory setting under paragraph (1).”

Pub. L. 103–66, § 13532(a)(1)Subsec. (i)(3)(B)(ii). , in introductory provisions substituted “paragraph (4)” for “the last sentence of this clause” and struck out concluding provisions which read as follows: “In the case of a hospital that makes application to the Secretary and demonstrates that it specializes in eye services or eye and ear services (as determined by the Secretary), receives more than 30 percent of its total revenues from outpatient services and was an eye specialty hospital or an eye and ear specialty hospital on , the cost proportion and ASC proportion in effect under subclauses (I) and (II) for cost reporting periods beginning in fiscal year 1988 shall remain in effect for cost reporting periods beginning on or after , and before .”

Pub. L. 103–66, § 13532(a)(2)Subsec. (i)(4). , added par. (4).

lPub. L. 103–66, § 13516(b)(1)Subsec. ()(4)(B)(i). , inserted “and before ,” after “1991,”.

lPub. L. 103–66, § 13516(b)(2)Subsec. ()(4)(B)(ii). , inserted “and” at end of subcl. (II), substituted a period for the comma at end of subcl. (III), and struck out subcls. (IV) to (VII) which read as follows:

“(IV) for services furnished in 1994, $11.25,

“(V) for services furnished in 1995, $11.50,

“(VI) for services furnished in 1996, $11.70, and

section 1395w–4(d)(3) of this title“(VII) for services furnished in calendar years after 1997, the previous year’s conversion factor increased by the update determined under for physician anesthesia services for that year.”

lPub. L. 103–66, § 13516(b)(3)Subsec. ()(4)(B)(iii). , added cl. (iii).

Pub. L. 101–508, § 4118(f)(2)(D)section 1395w–4 of this title1990—Subsec. (a)(1)(H). , struck out “, as the case may be” after “”.

Pub. L. 101–508, § 4104(b)(1)section 1395m(f) of this titleSubsec. (a)(1)(J). , struck out “or physician pathology services” after “1395m(b)(6) of this title)” and “or , respectively” after “1395m(b) of this title”.

Pub. L. 101–508, § 4155(b)(2)(A)Pub. L. 101–508, § 4153(a)(2)(B)(i)Subsec. (a)(1)(K). , which directed amendment of subpar. (K) by striking “and” at the end, could not be executed because of prior amendment by , see below.

Pub. L. 101–508, § 4153(a)(2)(B)(i), struck out “and” after “by a physician),”.

Pub. L. 101–508, § 4153(a)(2)(B)(ii)Subsec. (a)(1)(L). , substituted “subparagraph,” for “subparagraph and” at end.

Pub. L. 101–508, § 4155(b)(2)(B)Subsec. (a)(1)(M). , added subpar. (M) relating to nurse practitioner and clinical nurse specialist services.

Pub. L. 101–508, § 4153(a)(2)(B)(ii), added subpar. (M) relating to prosthetic devices and orthotics.

Pub. L. 101–508, § 4153(a)(2)(C)(i)Subsec. (a)(2). , substituted “(H), and (I)” for “and (H)” in introductory provisions.

Pub. L. 101–508, § 4163(d)(1)Subsec. (a)(2)(E)(i). , inserted “, but excluding screening mammography” after “imaging services”.

Pub. L. 101–508, § 4153(a)(2)(C)(ii)Subsec. (a)(7). –(iv), added par. (7).

Pub. L. 101–508, § 4302Subsec. (b). , inserted “for calendar years before 1991 and $100 for 1991 and subsequent years” after “$75”.

Pub. L. 101–508, § 4161(a)(3)(B)Subsec. (b)(5). , added par. (5) at end of first sentence.

Pub. L. 101–508, § 4154(a)(1)Subsec. (h)(2)(A)(ii). , substituted “clause (i)” for “any other provision of this subsection” in introductory provisions.

Pub. L. 101–508, § 4154(a)(2)Subsec. (h)(2)(A)(ii)(III). –(4), added subcl. (III).

Pub. L. 101–508, § 4154(b)(1)(B)Subsec. (h)(4)(B). , struck out “and” at end of cl. (ii), inserted “and before ,” after “1989,” in cl. (iii), substituted “, and” for period at end of cl. (iii), and added cl. (iv).

Pub. L. 101–508, § 4154(e)(1)(A)Subsec. (h)(5)(A)(ii)(II). , substituted “wholly owned by” for “a wholly-owned subsidiary of”.

Pub. L. 101–508, § 4154(e)(1)(C)Subsec. (h)(5)(A)(ii)(III). , substituted “receives requests for testing during the year in which the test is performed” for “submits bills or requests for payment in any year”.

Pub. L. 101–508, § 4154(e)(1)(B), which directed substitution of “laboratory (but not including a laboratory described in subclause (II)),” for “laboratory”, was executed by making the substitution for “laboratory” the second time appearing to reflect the probable intent of Congress.

Pub. L. 101–508, § 4008(m)(2)(C)Pub. L. 101–239, § 6003(g)(3)(C)(vii)(I)Pub. L. 101–239, § 6003(g)(3)(D)(vii)(I)Subsec. (h)(5)(A)(iii). , which directed technical correction to , was executed by making technical correction to , resulting in no change in text. See 1989 Amendment note below.

Pub. L. 101–508, § 4154(c)(1)(A)Subsec. (h)(5)(C). , substituted “test, including a test performed in a physician’s office but excluding a test performed by a rural health clinic” for “test performed by a laboratory other than a rural health clinic”.

Pub. L. 101–508, § 4154(c)(1)(B)Subsec. (h)(5)(D). , substituted “test, including a test performed in a physician’s office but excluding a test performed by a rural health clinic,” for “test performed by a laboratory, other than a rural health clinic”.

Pub. L. 101–508, § 4151(c)(1)(B)Subsec. (i)(3)(B)(ii). , substituted “on or after , and before ” for “in fiscal year 1989 or fiscal year 1990” in last sentence.

Pub. L. 101–508, § 4151(c)(1)(A)(i)Subsec. (i)(3)(B)(ii)(I). , substituted “50 percent for reporting periods beginning on or after , and on or before , and 42 percent for portions of cost reporting periods beginning on or after ” for “and 50 percent for other cost reporting periods”.

Pub. L. 101–508, § 4151(c)(1)(A)(ii)Subsec. (i)(3)(B)(ii)(II). , substituted “50 percent for reporting periods beginning on or after , and on or before , and 58 percent for portions of cost reporting periods beginning on or after ” for “and 50 percent for other cost reporting periods”.

lPub. L. 101–508, § 4160(1)Subsec. ()(1). , designated existing provisions as subpar. (A) and added subpars. (B) and (C).

lPub. L. 101–508, § 4160(2)section 1395u(i)(3) of this titleSubsec. ()(2). , struck out at end “The fee schedule shall be adjusted annually (to become effective on January 1 of each calendar year) by the percentage increase in the MEI (as defined in ) for that year.”

lPub. L. 101–508, § 4160(3)Subsec. ()(4). , added par. (4) and struck out former par. (4) which read as follows: “In establishing the fee schedule under paragraph (1), the Secretary may utilize a system of time units, a system of base and time units, or any appropriate methodology. The Secretary may establish a nationwide fee schedule or adjust the fee schedule for geographic areas (as the Secretary may determine to be appropriate).”

Pub. L. 101–597Subsec. (m). substituted “health professional shortage area” for “health manpower shortage area”.

Pub. L. 101–508, § 4151(c)(2)Subsec. (n)(1)(B)(ii)(I). , inserted before period at end “, and such term means 42 percent in the case of outpatient radiology services for portions of cost reporting periods beginning on or after ”.

Pub. L. 101–508, § 4206(b)(2)Subsec. (r). , added subsec. (r) relating to other prepaid organizations.

Pub. L. 101–508, § 4155(b)(3), added subsec. (r) relating to cap on prevailing charge and billing on assignment-related basis.

Pub. L. 101–234, § 202(a)Pub. L. 100–360, § 212(c)(2)1989—Subsec. (a). , repealed , and provided that the provisions of law amended or repealed by such section are restored or revised as if such section had not been enacted, see 1988 Amendment note below.

Pub. L. 101–234, § 201(a)Pub. L. 100–360, § 205(c)(3), repealed , and provided that the provisions of law amended or repealed by such section are restored or revived as if such section had not been enacted, see 1988 Amendment note below.

Pub. L. 101–239, § 6113(b)(3)(A)Subsec. (a)(1)(F). , added subpar. (F).

Pub. L. 101–239, § 6102(e)(5)section 1395w–4 of this titleSubsec. (a)(1)(H). , inserted “(or, for services furnished on or after , the fee schedule amount provided under , as the case may be)” after “prevailing charge that would be recognized”.

Pub. L. 101–239, § 6102(f)(2)section 1395m(f) of this titleSubsec. (a)(1)(J). , inserted “or physician pathology services” after “1395m(b)(6) of this title)” and “or , respectively” after “1395m(b) of this title”.

Pub. L. 101–239, § 6102(e)(6)(A)section 1395w–4 of this title, inserted “subject to ,” before “the amounts”.

Pub. L. 101–239, § 6102(e)(7)section 1395w–4 of this titleSubsec. (a)(1)(K). , inserted “, or, for services furnished on or after , 65 percent of the fee schedule amount provided under for the same service performed by a physician” after “for the same service performed by a physician”.

Pub. L. 101–234, § 201(a)Pub. L. 100–360, § 201(b)(1)Subsec. (a)(1)(M). , repealed , and provided that the provisions of law amended or repealed by such section are restored or revived as if such section had not been enacted, see 1988 Amendment note below.

Pub. L. 101–239, § 6102(e)(1)(B)Subsec. (a)(1)(N). , added subpar. (N).

Pub. L. 101–239, § 6116(b)(1)(A)Subsec. (a)(2). , substituted “(G), and (H)” for “and (G)” in introductory provisions.

Pub. L. 101–234, § 201(a)Pub. L. 100–360, repealed , §§ 202(b)(2), 203(c)(1)(A)–(D), 204(d)(1), and 205(c)(1), and provided that the provisions of law amended or repealed by such sections are restored or revived as if such sections had not been enacted, see 1988 Amendment notes below.

Pub. L. 101–234, § 201(a)Pub. L. 100–360, § 205(c)(2)Subsec. (a)(3). , repealed , and provided that the provisions of law amended or repealed by such section are restored or revived as if such section had not been enacted, see 1988 Amendment note below.

Pub. L. 101–239, § 6116(b)(1)(B)Subsec. (a)(6). –(D), added par. (6).

Pub. L. 101–234, § 201(a)Pub. L. 100–360Subsec. (b). , repealed , §§ 202(b)(3), 203(c)(1)(E), and provided that the provisions of law amended or repealed by such sections are restored or revived as if such sections had not been enacted, see 1988 Amendment notes below.

Pub. L. 101–234, § 201(a)Pub. L. 100–360, § 201(a)(1)Subsec. (c). , repealed , (4), and provided that the provisions of law amended or repealed by such section are restored or revived as if such section had not been enacted, see 1988 Amendment notes below.

Pub. L. 101–234, § 201(a)Pub. L. 100–360, § 201(a)(1)(D)Subsec. (d). , repealed , (2), and provided that the provisions of law amended or repealed by such section are restored or revived as if such section had not been enacted, see 1988 Amendment notes below.

Pub. L. 101–239, § 6113(d)Subsec. (d)(1). , substituted “62½ percent of such expenses.” for “whichever of the following amounts is the smaller:

“(A) $1375.00, or

“(B) 62½ percent of such expenses.”

Pub. L. 101–239, § 6133(a)Subsec. (g). , substituted “$750” for “$500” in two places.

Pub. L. 101–234, § 201(a)Pub. L. 100–360, § 201(a)(3), repealed , and provided that the provisions of law amended or repealed by such section are restored or revived as if such section had not been enacted, see 1988 Amendment note below.

Pub. L. 101–239, § 6111(a)(1)Subsec. (h)(1)(B), (C). , substituted “on or after ” for “during the period beginning on , and ending on . For such tests furnished on or after , the fee schedule shall be established on a nationwide basis.”

Pub. L. 101–239, § 6003(e)(2)(A)section 1395ww(d)(5)(D)(iii) of this titlesection 1395ww(d)(5)(C)(ii) of this titleSubsec. (h)(1)(D). , substituted “” for “the last sentence of ”.

Pub. L. 101–239, § 6111(a)(3)(A)Subsec. (h)(4)(B)(ii). , (B), substituted “after , and before ,” for “after , and so long as a fee schedule for the test has not been established on a nationwide basis,”.

Pub. L. 101–239, § 6111(a)(2)Subsec. (h)(4)(B)(iii). , (3)(C), (4), added cl. (iii).

Pub. L. 101–239, § 6111(b)(1)Subsec. (h)(5)(A)(ii). , substituted “referring laboratory but only if—” for “referring laboratory, and” in introductory provisions, and added subcls. (I) through (III).

Pub. L. 101–239, § 6003(g)(3)(D)(vii)(I)Pub. L. 101–508, § 4008(m)(2)(C)Subsec. (h)(5)(A)(iii). , as amended by , substituted “hospital or rural primary care hospital,” for “hospital,”.

Pub. L. 101–239, § 6003(g)(3)(D)(vii)(II)section 1395k(a)(2)(F)(i) of this titleSubsec. (i)(1)(A). , inserted “, rural primary care hospital,” after “)”.

Pub. L. 101–239, § 6003(g)(3)(D)(vii)(III)Subsec. (i)(3)(A). , inserted “or rural primary care hospital services” after “facility services” in introductory provisions.

lPub. L. 101–239, § 6003(g)(3)(D)(vii)(IV)Subsec. ()(5)(A). , inserted “rural primary care hospital,” after “hospital,” in two places.

lPub. L. 101–239, § 6003(g)(3)(D)(vii)(V)Subsec. ()(5)(C). , substituted “hospital or rural primary care hospital” for “hospital” in two places.

Pub. L. 101–239, § 6102(c)(1)Subsec. (m). , struck out “class 1 or class 2” before “health manpower shortage area” and substituted “10 percent” for “5 percent”.

oPub. L. 101–239, § 6131(a)(1)(C)Subsec. ()(1). , inserted “(or inserts)” after “shoes” in two places in last sentence.

oPub. L. 101–239, § 6131(a)(1)(A)Subsec. ()(1)(A). , amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: “no payment may be made under this part for the furnishing of more than one pair of shoes for any individual for any calendar year, and”.

oPub. L. 101–239, § 6131(a)(1)(B)Subsec. ()(1)(B), (2)(A). , substituted “limits” for “limit”.

oPub. L. 101–239, § 6131(a)(1)(D)Subsec. ()(2)(A)(i). , amended cl. (i) generally. Prior to amendment, cl. (i) read as follows: “for the furnishing of one pair of custom molded shoes is $300”.

oPub. L. 101–239, § 6131(a)(1)(E)Subsec. ()(2)(A)(ii)(II). , inserted “any pairs of” after “$50 for”.

oPub. L. 101–239, § 6131(b)Subsec. ()(2)(D). , added subpar. (D).

Pub. L. 101–239, § 6113(b)(3)(B)section 1395x(s)(2)(N) of this titlesection 1395x(s)(2)(M) of this titleSubsec. (p). , substituted “1395x(s)(2)(L) of this title,” for “1395x(s)(2)(L) of this title and” and inserted “and in the case of clinical social worker services for which payment may be made under this part only pursuant to ,” after “,”.

Pub. L. 101–239, § 6204(b)Subsec. (q). , added subsec. (q).

Pub. L. 100–360, § 212(c)(2)section 1395t–1(c) of this title1988—Subsec. (a). , inserted “or, as provided in , from the Federal Catastrophic Drug Insurance Trust Fund” after “Fund” in introductory provisions.

Pub. L. 100–360, § 205(c)(3), inserted provision at end relating to payment for in-home care for chronically dependent individuals.

Pub. L. 100–360, § 411(i)(4)(C)(i)Pub. L. 100–203, § 4085(i)(1)(A)Subsec. (a)(1)(D)(i). , amended , see 1987 Amendment note below.

Pub. L. 100–360, § 411(f)(12)(A)Pub. L. 100–203, § 4055(a)(1)Subsec. (a)(1)(F). , (14), added and renumbered , see 1987 Amendment note below.

Pub. L. 100–360, § 411(i)(4)(C)(iv)Pub. L. 100–203, § 4085(i)(21)(D)(i), made technical amendment to directory language of , see 1987 Amendment note below.

Pub. L. 100–360, § 411(i)(4)(C)(ii)Pub. L. 100–203, § 4085(i)(1)(B), repealed , see 1987 Amendment note below.

Pub. L. 100–360, § 411(h)(4)(B)(i)Pub. L. 100–203, § 4073(b)(1)(A), (ii), redesignated and amended directory language of , see 1987 Amendment note below.

Pub. L. 100–360, § 411(h)(7)(C)(ii)Pub. L. 100–203, § 4077(b)(3)(A)Subsec. (a)(1)(G). , repealed , see 1987 Amendment note below.

Pub. L. 100–360, § 411(h)(4)(B)(iii)Pub. L. 100–203, § 4073(b)(2)(B), repealed , see 1987 Amendment note below.

Pub. L. 100–360, § 411(h)(7)(C)(ii)Pub. L. 100–203, § 4077(b)(3)(B)Subsec. (a)(1)(H). , repealed , see 1987 Amendment note below.

Pub. L. 100–360, § 411(g)(1)(E)section 4049(a)(1) of Pub. L. 100–203, which directed the amendment of subpar. (H) by striking “and” before “(I)” could not be executed because of the prior amendment by , see 1987 Amendment note below.

Pub. L. 100–360, § 411(i)(3)Pub. L. 100–203, § 4084(c)(2), added , see 1987 Amendment note below.

Pub. L. 100–360, § 411(f)(8)(B)(i)Pub. L. 100–203, § 4049(a)(1)Subsec. (a)(1)(J). , made technical amendment to directory language of , see 1987 Amendment note below.

Pub. L. 100–360, § 411(f)(8)(C)section 1395m(b)(6) of this titlesection 1395m(b)(5) of this title, substituted “” for “”.

Pub. L. 100–360, § 411(h)(7)(C)(iii)Pub. L. 100–203, § 4077(b)(2)(A)Subsec. (a)(1)(K). , (F), redesignated and amended , see 1987 Amendment note below.

Pub. L. 100–360, § 411(h)(4)(B)(i)Pub. L. 100–203, § 4073(b)(1)(B), (iv), (v), redesignated and amended , see 1987 Amendment note below.

Pub. L. 100–360, § 411(h)(7)(C)(i)Pub. L. 100–203, § 4077(b)(2)(B)Subsec. (a)(1)(L). , (iv), (v), (F), redesignated and amended , see 1987 Amendment note below.

Pub. L. 100–360, § 202(b)(1)Subsec. (a)(1)(M). , added subpar. (M) relating to expenses incurred for covered outpatient drugs.

Pub. L. 100–360, § 205(c)(1)Subsec. (a)(2). , inserted “(A)(ii),” after “subparagraphs” in introductory provisions.

Pub. L. 100–360, § 202(b)(2), inserted “(other than covered outpatient drugs)” after “in the case of services” in introductory provisions.

Pub. L. 100–360, § 203(c)(1)(A)Subsec. (a)(2)(B). , substituted “(E), or (F)” for “or (E)” in introductory provisions.

Pub. L. 100–360, § 411(i)(4)(C)(i)Pub. L. 100–203, § 4085(i)(1)(A)Subsec. (a)(2)(D)(i). , amended , see 1987 Amendment note below.

Pub. L. 100–360, § 204(d)(1)Subsec. (a)(2)(E)(i). , inserted “, but excluding screening mammography” after “imaging services”.

Pub. L. 100–360, § 203(c)(1)(B)Subsec. (a)(2)(F). –(D), added subpar. (F) relating to home intravenous drug therapy services.

Pub. L. 100–360, § 205(c)(2)Subsec. (a)(3). , substituted “subparagraphs (A)(ii), (D),” for “subparagraphs (D)”.

Pub. L. 100–360, § 104(d)(7)Pub. L. 100–485, § 608(d)(3)(G)section 1395e(a)(2) of this titleSubsec. (b). , as added by , inserted at end “The deductible under the previous sentence for blood or blood cells furnished an individual in a year shall be reduced to the extent that a deductible has been imposed under to blood or blood cells furnished the individual in the year.”

Pub. L. 100–360, § 202(b)(3)(A)section 1395x(s)(10)(A) of this titleSubsec. (b)(1). , inserted “or for covered outpatient drugs” after “”.

Pub. L. 100–360, § 203(c)(1)(E)Subsec. (b)(2). , substituted “services and home intravenous drug therapy services” for “services”.

Pub. L. 100–360, § 202(b)(3)(B), inserted “or with respect to covered outpatient drugs” after “home health services”.

Pub. L. 100–360, § 411(f)(12)(A)Pub. L. 100–203, § 4055(a)(2)Subsec. (b)(3) to (5). , (14), added and renumbered , see 1987 Amendment note below.

Pub. L. 100–360, § 201(a)(4)Subsec. (c). , added subsec. (c) relating to limitation on out-of-pocket catastrophic cost-sharing, adjustment, buy-out plans, and conditions for payments with respect to plans other than buy-out plans. Former subsec. (c) redesignated (d)(1).

Pub. L. 100–360, § 411(h)(1)(A), substituted “monitoring or changing drug prescriptions” for “prescribing or monitoring prescription drugs” in last sentence.

Pub. L. 100–360, § 201(a)(1)(A)Pub. L. 100–485, § 608(d)(4), as amended by , substituted “subsections (a) through (c)” for “subsections (a) and (b)” in introductory provisions.

Pub. L. 100–360, § 201(a)(1)(B), (C), redesignated former pars. (1) and (2) as subpars. (A) and (B) and substituted “this paragraph” for “this subsection” in last sentence.

Pub. L. 100–360, § 201(a)(1)(D)Subsec. (d)(1). , redesignated former subsec. (c) as subsec. (d)(1). Former subsec. (d) redesignated subsec. (d)(2).

Pub. L. 100–360, § 201(a)(2)Subsec. (d)(2). , redesignated former subsec. (d) as subsec. (d)(2).

Pub. L. 100–360, § 411(g)(5)section 1395u(i)(3) of this titlesection 1395u(i)(4) of this titlesection 1395u(b)(3) of this titleSubsec. (f). , substituted “MEI (as defined in ) applicable to primary care services (as defined in )” for “medicare economic index (referred to in the fourth sentence of ) applicable to physicians’ services”.

Pub. L. 100–360, § 201(a)(3)Subsec. (g). , substituted “subsections (a) through (c) of this section” for “subsections (a) and (b) of this section” in two places.

Pub. L. 100–360, § 411(g)(3)(E)Pub. L. 100–203, § 4064(c)(1)Subsec. (h)(1)(D). , (F), amended and redesignated , see 1987 Amendment note below.

Pub. L. 100–360, § 411(g)(3)(A)Pub. L. 100–203, § 4064(a)(1)Subsec. (h)(2)(A)(i). , added , see 1987 Amendment note below.

Pub. L. 100–360, § 411(g)(3)(A)Pub. L. 100–203, § 4064(a)(3)Subsec. (h)(2)(A)(ii). , added , see 1987 Amendment note below.

Pub. L. 100–360, § 411(g)(3)(B)Pub. L. 100–203, § 4064(b)(1)Subsec. (h)(2)(A)(iii). , (C), amended , see 1987 Amendment note below.

Pub. L. 100–360, § 411(g)(3)(A)Pub. L. 100–203, § 4064(a)(2)Subsec. (h)(2)(B). , added , see 1987 Amendment note below.

Pub. L. 100–647, § 8421(a)Subsec. (h)(3). , inserted at end “In establishing a fee to cover the transportation and personnel expenses for trained personnel to travel to the location of an individual to collect a sample, the Secretary shall provide a method for computing the fee based on the number of miles traveled and the personnel costs associated with the collection of each individual sample, but the Secretary shall only be required to apply such method in the case of tests furnished during the period beginning on , and ending on , by a laboratory that establishes to the satisfaction of the Secretary (based on data for the 12-month period ending ) that (i) the laboratory is dependent upon payments under this subchapter for at least 80 percent of its collected revenues for clinical diagnostic laboratory tests, (ii) at least 85 percent of its gross revenues for such tests are attributable to tests performed with respect to individuals who are homebound or who are residents in a nursing facility, and (iii) the laboratory provided such tests for residents in nursing facilities representing at least 20 percent of the number of such facilities in the State in which the laboratory is located.”

Pub. L. 100–360, § 411(g)(3)(D)Subsec. (h)(4)(B)(ii). , inserted “after” before “”.

Pub. L. 100–360, § 411(i)(4)(C)(vi)Pub. L. 100–203, § 4085(i)(22)(B)Subsec. (h)(5)(A). , added , see 1987 Amendment note below.

Pub. L. 100–360, § 411(i)(4)(C)(vi)Pub. L. 100–203, § 4085(i)(22)(B)Subsec. (h)(5)(C). , added , see 1987 Amendment note below.

Pub. L. 100–360, § 411(i)(4)(B)section 1395u(j) of this titlesection 1395u(j)(2) of this titleSubsec. (h)(5)(D). , substituted “A person may not bill for a clinical diagnostic laboratory test performed by a laboratory, other than a rural health clinic, other than on an assignment-related basis. If a person knowingly and willfully and on a repeated basis bills for a clinical diagnostic laboratory test in violation of the previous sentence” for “If a person knowingly and willfully and on a repeated basis bills an individual enrolled under this part for charges for a clinical diagnostic laboratory test for which payment may only be made on an assignment-related basis under subparagraph (C)” and “paragraphs (2) and (3) of in the same manner such paragraphs apply with respect to a physician” for “”.

Pub. L. 100–360, § 411(g)(2)(D)Subsec. (i)(2)(A)(iii). , substituted “insertion” for “implantation” and inserted “or subsequent to” after “during”.

Pub. L. 100–360, § 411(f)(12)(A)Pub. L. 100–203, § 4055(a)(3)Subsec. (i)(4). , (14), added and renumbered , see 1987 Amendment note below.

Pub. L. 100–485, § 608(d)(22)(B)Subsec. (i)(6). , substituted “Any person, including” for “Any person, other than”.

Pub. L. 100–360, § 411(g)(2)(E)Pub. L. 100–203, § 4063(e)(1), added , see 1987 Amendment note below.

lPub. L. 100–360, § 411(f)(2)(D)Pub. L. 100–203, § 4042(b)(2)(B)Subsec. ()(2). , added , see 1987 Amendment note below.

lPub. L. 100–647, § 8422(a)Subsec. ()(3)(B). , inserted “plus applicable coinsurance” after “would have been paid”.

lPub. L. 100–360, § 411(i)(4)(C)(vi)Pub. L. 100–203, § 4085(i)(23)Subsec. ()(5)(B)(ii). , added , see 1987 Amendment note below.

Pub. L. 100–360, § 411(g)(4)(C)(i)Pub. L. 100–485, § 608(d)(22)(D)Subsec. (n)(1)(A). , as amended by , substituted “for services described in subsection (a)(2)(E)(i) furnished under this part on or after , and for services described in subsection (a)(2)(E)(ii) furnished under this part on or after ,” for “beginning on or after under this part for services described in subsection (a)(2)(E)” in introductory provisions.

Pub. L. 100–360, § 411(g)(4)(C)(ii)Subsec. (n)(1)(B)(i)(II). , inserted “or (for services described in subsection (a)(2)(E)(i) furnished on or after ) the fee schedule amount established” after “the prevailing charge”.

Pub. L. 100–360, § 411(g)(4)(C)(iii)Subsec. (n)(1)(B)(ii). , amended subcls. (I) and (II) generally. Prior to amendment, subcls. (I) and (II) read as follows:

“(I) The term ‘cost proportion’ means 65 percent for all or any part of cost reporting periods which occur in fiscal year 1989 and 50 percent for other cost reporting periods.

“(II) The term ‘charge proportion’ means 35 percent for all or any parts of cost reporting periods which occur in fiscal year 1989 and 50 percent for other cost reporting periods.”

oPub. L. 100–360, § 411(h)(3)(B)Pub. L. 100–485, § 608(d)(23)(A)Pub. L. 100–203, § 4072(b)Subsec. (). , as amended by , amended , see 1987 Amendment note below.

Pub. L. 100–360, § 411(h)(7)(D)Pub. L. 100–203, § 4077(b)(3)Subsec. (p). , (F), redesignated and amended , see 1987 Amendment note below.

Pub. L. 100–360, § 411(h)(4)(C)Pub. L. 100–203, § 4073(b)(2), redesignated and amended , see 1987 Amendment note below.

Pub. L. 100–203, § 4085(i)(1)(A)Pub. L. 100–360, § 411(i)(4)(C)(i)section 1395u(b)(3)(B)(ii) of this titlesection 1395gg(f)(1) of this title1987—Subsec. (a)(1)(D)(i). , as amended by , substituted “on an assignment-related basis,” for “on the basis of an assignment described in , under the procedure described in ,”.

Pub. L. 100–203, § 4055(a)(1)Pub. L. 100–360, § 411(f)(12)(A)Subsec. (a)(1)(F). , formerly § 4054(a)(1), as added and renumbered by , (14), struck out subpar. (F) which read as follows: “with respect to expenses incurred for services described in subsection (i)(4) of this section under the conditions specified in such subsection, the amounts paid shall be the reasonable charge for such services,”.

Pub. L. 100–203, § 4085(i)(21)(D)(i)Pub. L. 100–360, § 411(i)(4)(C)(iv)Pub. L. 99–509, § 9343(e)(2)(A), as amended by , amended , see 1986 Amendment note below.

Pub. L. 100–203, § 4085(i)(1)(B)Pub. L. 100–360, § 411(i)(4)(C)(ii), which directed striking out “and” at end, was repealed by .

Pub. L. 100–203, § 4073(b)(1)(A)Pub. L. 100–360, § 411(h)(4)(B)(i), formerly § 4073(b)(2)(A), as redesignated and amended by , (ii), struck out “and” at end.

Pub. L. 100–203, § 4077(b)(3)(A)Pub. L. 100–360, § 411(h)(7)(C)(ii)Subsec. (a)(1)(G). , which directed striking out “and” at end, was repealed by .

Pub. L. 100–203, § 4073(b)(2)(B)Pub. L. 100–360, § 411(h)(4)(B)(iii), which directed substituting “services,” for “services; and”, was repealed by .

Pub. L. 100–203, § 4062(d)(3)(A)(i), substituted “services,” for “services; and”.

Pub. L. 100–203, § 4077(b)(3)(B)Pub. L. 100–360, § 411(h)(7)(C)(ii)Subsec. (a)(1)(H). , which directed substituting “services,” for “services; and”, was repealed by .

Pub. L. 100–203, § 4084(c)(2)Pub. L. 100–360, § 411(i)(3), as added by , substituted “least of the actual charge, the prevailing charge that would be recognized if the services had been performed by an anesthesiologist,” for “lesser of the actual charge”.

Pub. L. 100–203, § 4062(d)(3)(A)(ii)section 4062(d)(3)(A)(ii) of Pub. L. 100–203, inserted “and” before the subpar. (I) added by , see below.

Pub. L. 100–203, § 4049(a)(1)section 4062(d)(3)(A)(ii) of Pub. L. 100–203, struck out “and” before the subpar. (I) added by , see below.

Pub. L. 100–203, § 4062(d)(3)(A)(ii)Subsec. (a)(1)(I). , added subpar. (I).

Pub. L. 100–203, § 4049(a)(1)Pub. L. 100–360, § 411(f)(8)(B)(i)Subsec. (a)(1)(J). , as amended by , added subpar. (J).

Pub. L. 100–203, § 4077(b)(2)(A)Pub. L. 100–360, § 411(h)(7)(C)(iii)Subsec. (a)(1)(K). , formerly § 4077(b)(3)(C), as redesignated and amended by , (F), inserted “and” after “performed by a physician),”.

Pub. L. 100–203, § 4073(b)(1)(B)Pub. L. 100–360, § 411(h)(4)(B)(i)section 1395x(s)(2)(L) of this title, formerly § 4073(b)(2)(C), as redesignated and amended by , (iv), (v), added subpar. (K), formerly (I), relating to amounts paid with respect to certified nurse-midwife services under .

Pub. L. 100–203, § 4077(b)(2)(B)Pub. L. 100–360, § 411(h)(7)(C)(i)section 1395x(s)(2)(M) of this titleSubsec. (a)(1)(L). , formerly § 4077(b)(3)(D), as redesignated and amended by , (iv), (v), (F), added subpar. (L), formerly (J), relating to amounts paid with respect to qualified psychologist services under .

Pub. L. 100–203, § 4062(d)(3)(B)(i)Subsec. (a)(2). , inserted reference to subpar. (G).

Pub. L. 100–203, § 4062(d)(3)(B)(ii)Subsec. (a)(2)(A). , struck out “(other than durable medical equipment)” after “home health services”.

Pub. L. 100–203, § 4066(b)Subsec. (a)(2)(B). , inserted reference to subpar. (E).

Pub. L. 100–203, § 4085(i)(1)(A)Pub. L. 100–360, § 411(i)(4)(C)(i)section 1395u(b)(3)(B)(ii) of this titlesection 1395gg(f)(1) of this titleSubsec. (a)(2)(D)(i). , as amended by , substituted “on an assignment-related basis,” for “on the basis of an assignment described in , under the procedure described in ,”.

Pub. L. 100–203, § 4066(a)(1)Subsec. (a)(2)(E). , added subpar. (E).

Pub. L. 100–203, § 4062(d)(3)(C)Subsec. (a)(5). –(E), added par. (5).

Pub. L. 100–203, § 4055(a)(2)Pub. L. 100–360, § 411(f)(12)(A)Subsec. (b)(3). , formerly § 4054(a)(2), as added and renumbered by , (14), redesignated par. (4) as (3) and struck out former par. (3) which read as follows: “such total amount shall not include expenses incurred for services the amount of payment for which is determined under subsection (a)(1)(F) of this section,”.

Pub. L. 100–203, § 4085(i)(21)(D)(i)Pub. L. 99–509, § 9343(e)(2)(A), amended , see 1986 Amendment note below.

Pub. L. 100–203, § 4055(a)(2)Pub. L. 100–360, § 411(f)(12)(A)Subsec. (b)(4). , formerly § 4054(a)(2), as added and renumbered by , (14), redesignated par. (5) as (4). Former par. (4) redesignated (3).

Pub. L. 100–203, § 4085(i)(1)(C)section 1395u(b)(3)(B)(ii) of this titlesection 1395gg(f)(1) of this titleSubsec. (b)(4)(A). , substituted “on an assignment-related basis” for “on the basis of an assignment described in , under the procedure described in ”.

Pub. L. 100–203, § 4055(a)(2)Pub. L. 100–360, § 411(f)(12)(A)Subsec. (b)(5). , formerly § 4054(a)(2), as added and renumbered by , (14), redesignated par. (5) as (4).

Pub. L. 100–203, § 4070(b)(4)Subsec. (c). , inserted “or partial hospitalization services that are not directly provided by a physician” before period at end of last sentence.

Pub. L. 100–203, § 4070(a)(2), inserted sentence at end defining “treatment”.

Pub. L. 100–203, § 4070(a)(1)Subsec. (c)(1). , substituted “$1375.00” for “$312.50”.

Pub. L. 100–203, § 4067(a)Subsec. (f). , added subsec. (f).

Pub. L. 100–203, § 4085(i)(2)Subsec. (h)(1)(C). , inserted before period at end “, and ending on . For such tests furnished on or after , the fee schedule shall be established on a nationwide basis”.

Pub. L. 100–203, § 4064(c)(1)Pub. L. 100–360, § 411(g)(3)(E)section 1395ww(d)(5)(C)(ii) of this titleSubsec. (h)(1)(D). , formerly § 4064(c), as amended and redesignated by , (F), inserted “, in a sole community hospital (as defined in the last sentence of ),”.

Pub. L. 100–203, § 4064(c)section 411(g)(3)(F) of Pub. L. 100–360section 411(g)(3)(E) of Pub. L. 100–360Subsec. (h)(2). , which had directed that “laboratory in a sole community hospital” be substituted for “hospital laboratory” in subsec. (h)(2), was redesignated § 4064(c)(1) by and amended by to provide for amendment of subsec. (h)(1)(D) instead of subsec. (h)(2).

Pub. L. 100–203, § 4064(a)(1)Pub. L. 100–360, § 411(g)(3)(A)Subsec. (h)(2)(A)(i). , as added by , inserted “(A)(i)” after “(2)”.

Pub. L. 100–203, § 4064(a)(3)Pub. L. 100–360, § 411(g)(3)(A)Subsec. (h)(2)(A)(ii). , as added by , added cl. (ii).

Pub. L. 100–203, § 4064(b)(1)Pub. L. 100–360, § 411(g)(3)(B)Subsec. (h)(2)(A)(iii). , as amended by , (C), set out as cl. (iii) provisions formerly set out in an otherwise undesignated sentence in par. (2) relating to the rebasing of fee schedules for certain automated and similar tests for 1988 and for the continuation of such reduced fee schedules as the base for 1989 and subsequent years.

Pub. L. 100–203, § 4064(a)(2)Pub. L. 100–360, § 411(g)(3)(A)Subsec. (h)(2)(B). , as added by , inserted subpar. (B) designation preceding second sentence and redesignated former subpars. (A) and (B) of par. (2) as cls. (i) and (ii).

Pub. L. 100–203, § 4064(b)(2)(A)Subsec. (h)(4)(B)(i). , substituted “April” for “January”.

Pub. L. 100–203, § 4064(b)(2)(B)Subsec. (h)(4)(B)(ii). , amended cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: “after , and so long as a fee schedule for the test has not been established on a nationwide basis, is equal to 110 percent of the median of all the fee schedules established for that test for that laboratory setting under paragraph (1).”

Pub. L. 100–203, § 4085(i)(22)(B)Pub. L. 100–360, § 411(i)(4)(C)(vi)section 1395u(b)(3)(B)(ii) of this titlesection 1395gg(f)(1) of this titleSubsec. (h)(5)(A). , as added by , substituted “on an assignment-related basis” for “on the basis of an assignment described in , under the procedure described in ,” in introductory provisions.

Pub. L. 100–203, § 4085(i)(3)Subsec. (h)(5)(A)(iii). , added cl. (iii).

Pub. L. 100–203, § 4085(i)(22)(B)Pub. L. 100–360, § 411(i)(4)(C)(vi)section 1395u(b)(3)(B)(ii) of this titlesection 1395u(b)(6)(B) of this titlesection 1395gg(f)(1) of this titleSubsec. (h)(5)(C). , as added by , substituted “on an assignment-related basis” for “on the basis of an assignment described in , in accordance with , under the procedure described in ,”.

Pub. L. 100–203, § 4085(b)(1)Subsec. (h)(5)(D). , added subpar. (D).

Pub. L. 100–203, § 4063(b)Subsec. (i)(2)(A)(iii). , added cl. (iii).

Pub. L. 100–203, § 4068(a)(1)Subsec. (i)(3)(B)(ii). , substituted “Subject to the last sentence of this clause, in” for “In”.

Pub. L. 100–203, § 4068(a)(2), inserted sentence at end relating to cost and ASC proportions in the case of an eye or eye and ear specialty hospital.

Pub. L. 100–203, § 4055(a)(3)Pub. L. 100–360, § 411(f)(12)(A)section 1395x(s) of this titlesection 1395u(b)(3)(B)(ii) of this titleSubsec. (i)(4). , formerly § 4054(a)(3), as added and renumbered by , (14), struck out par. (4) which read as follows: “In the case of services (including all pre- and post-operative services) described in paragraphs (1) and (2)(A) of and furnished in connection with surgical procedures (specified pursuant to paragraph (1) of this subsection) in a physician’s office, an ambulatory surgical center described in such paragraph, or a hospital outpatient department, payment for such services shall be determined in accordance with subsection (a)(1)(F) of this section if the physician accepts an assignment described in with respect to payment for such services.”

Pub. L. 100–203, § 4063(e)(1)Pub. L. 100–360, § 411(g)(2)(E)Subsec. (i)(6). , as added by , added par. (6).

lPub. L. 100–203, § 4084(a)(1)Subsec. ()(2). , substituted “1985 and such other data as the Secretary determines necessary” for “1985”.

Pub. L. 100–203, § 4042(b)(2)(B)Pub. L. 100–360, § 411(f)(2)(D), as added by , substituted “1395u(i)(3)” for “1395u(b)(4)(E)(ii)”.

lPub. L. 100–203, § 4084(a)(2)Subsec. ()(5)(A). , substituted “group practice, or ambulatory surgical center” for “or group practice” in two places.

lPub. L. 100–203, § 4085(i)(23)Pub. L. 100–360, § 411(i)(4)(C)(vi)section 1320a–7a of this titleSubsec. ()(5)(B)(ii). , as added by , substituted “money penalty” for “monetary penalty” and amended second sentence generally. Prior to amendment, second sentence read as follows: “Such a penalty shall be imposed in the same manner as civil monetary penalties are imposed under with respect to actions described in subsection (a) of that section.”

lPub. L. 100–203, § 4045(c)(2)(A)(i)section 1395u(j)(1)(D) of this titleSubsec. ()(6). , (ii), struck out subpar. (A) designation and substituted “after the effective date of the reduction, the physician’s actual charge is subject to a limit under .” for “(subject to subparagraph (D)), the physician may not charge the individual more than the limiting charge (as defined in subparagraph (B)) plus (for services furnished during the 12-month period beginning on the effective date of the reduction) ½ of the amount by which the physician’s actual charges for the service for the previous 12-month period exceeds the limiting charge.”

Pub. L. 100–203, § 4045(c)(2)(A)(iii), struck out subpars. (B) to (D) which read as follows:

“(B) In subparagraph (A), the term ‘limiting charge’ means, with respect to a service, 125 percent of the prevailing charge for the service after the reduction referred to in subparagraph (A).

“(C) If a physician knowingly and willfully imposes charges in violation of subparagraph (A), the Secretary may apply sanctions against such physician in accordance with subsection (j)(2) of this section.

section 1395w–1(e)(3) of this titlesection 1395w–1 of this title“(D) This paragraph shall not apply to services furnished after the earlier of (i) , or (ii) one-year after the date the Secretary reports to Congress, under , on the development of the relative value scale under .”

Pub. L. 100–203, § 4043(a)Subsec. (m). , added subsec. (m).

Pub. L. 100–203, § 4066(a)(2)Subsec. (n). , added subsec. (n).

oPub. L. 100–203, § 4072(b)Pub. L. 100–360, § 411(h)(3)(B)Pub. L. 100–485, § 608(d)(23)(A)oSubsec. (). , as amended by , as amended by , added subsec. () [originally added as subsec. (f)].

Pub. L. 100–203, § 4077(b)(3)Pub. L. 100–360, § 411(h)(7)(D)section 1395x(s)(2)(M) of this titleSubsec. (p). , formerly § 4077(b)(4), as redesignated and amended by , (F), inserted “and in the case of qualified psychologists services for which payment may be made under this part only pursuant to ”.

Pub. L. 100–203, § 4073(b)(2)Pub. L. 100–360, § 411(h)(4)(C), formerly § 4073(b)(3), as redesignated and amended by , added subsec. (p) [originally added as subsec. (m)] and inserted provision relating to monetary penalty for whoever knowingly and willfully presents, or causes to be presented, to an enrolled individual a bill or request for payment for described services.

Pub. L. 99–272, § 9401(b)(2)(B)section 1395gg(f)(1) of this titlesection 1320c–13(c)(2) of this titlesection 1395gg(f)(1) of this title1986—Subsec. (a)(1)(D). , substituted “, under the procedure described in , or for tests furnished in connection with obtaining a second opinion required under (or a third opinion, if the second opinion was in disagreement with the first opinion)” for “or under the procedure described in ”.

Pub. L. 99–272, § 9303(b)(1)Subsec. (a)(1)(D)(i). , inserted “, the limitation amount for that test determined under subsection (h)(4)(B),” after “lesser of the amount determined under such fee schedule”.

Pub. L. 99–509, § 9343(e)(2)(A)Pub. L. 100–203, § 4085(i)(21)(D)(i)Subsec. (a)(1)(F). , as amended by , substituted “(i)(4)” for “(i)(3)”.

Pub. L. 99–272, § 9401(b)(2)(A)Subsec. (a)(1)(G). , added subpar. (G).

Pub. L. 99–509, § 9320(e)(1)Subsec. (a)(1)(H). , added subpar. (H).

Pub. L. 99–272, § 9401(b)(2)(C)section 1320c–13(c)(2) of this titleSubsec. (a)(2)(A). , inserted “, to items and services (other than clinical diagnostic laboratory tests) furnished in connection with obtaining a second opinion required under (or a third opinion, if the second opinion was in disagreement with the first opinion),” after “(other than durable medical equipment)”.

Pub. L. 99–272, § 9401(b)(2)(D)section 1395cc of this titlesection 1320c–13(c)(2) of this titlesection 1395cc of this titleSubsec. (a)(2)(D). , substituted “to a provider having an agreement under , or for tests furnished in connection with obtaining a second opinion required under (or a third opinion, if the second opinion was in disagreement with the first opinion)” for “or to a provider having an agreement under ”.

Pub. L. 99–272, § 9303(b)(1)Subsec. (a)(2)(D)(i). , inserted “, the limitation amount for that test determined under subsection (h)(4)(B),” after “lesser of the amount determined under such fee schedule”.

Pub. L. 99–272, § 9401(b)(2)(E)section 1320c–13(c)(2) of this titleSubsec. (a)(3). , inserted “and for items and services furnished in connection with obtaining a second opinion required under , or a third opinion, if the second opinion was in disagreement with the first opinion” after “1395x(s)(10)(A) of this title”.

Pub. L. 99–509, § 9343(a)(1)(A)section 1395k(a)(2) of this titleSubsec. (a)(4). , amended par. (4) generally. Prior to amendment, par. (4) read as follows: “in the case of facility services described in subparagraph (F) of , the applicable amount described in paragraph (2) of subsection (i) of this section.”

Pub. L. 99–509, § 9343(e)(2)(A)Pub. L. 100–203, § 4085(i)(21)(D)(i)Pub. L. 99–509, § 9343(a)(2)Subsec. (b)(3). , as amended by , which directed that par. (3) be amended by striking “or under subsection (i)(2) or (i)(4) of this section”, was executed by striking “or under subsection (i)(2) or (i)(5) of this section”, to reflect the probable intent of Congress and an earlier amendment by , see below.

Pub. L. 99–509, § 9343(a)(2), substituted “(i)(5)” for “(i)(4)”.

Pub. L. 99–272, § 9401(b)(1)Subsec. (b)(5). , added par. (5).

Pub. L. 99–509, § 9337(b)section 1395x(p) of this titlesection 1395x(g) of this titleSubsec. (g). , substituted “second sentence” for “next to last sentence”, and inserted at end “In the case of outpatient occupational therapy services which are described in the second sentence of through the operation of , with respect to expenses incurred in any calendar year, no more than $500 shall be considered as incurred expenses for purposes of subsections (a) and (b).”

Pub. L. 99–509, § 9339(b)(1)Subsec. (h)(1)(B). , substituted “” and “” for “” and “”, respectively.

Pub. L. 99–509, § 9339(a)(1)(A), substituted “qualified hospital laboratory (as defined in subparagraph (D))” for “hospital laboratory”.

Pub. L. 99–272, § 9303(a)(1)(A), substituted “” for “” and “” for “”.

Pub. L. 99–509, § 9339(a)(1)(B)Subsec. (h)(1)(C). , substituted “qualified hospital laboratory (as defined in subparagraph (D))” for “hospital laboratory”, struck out “, and ending on ” after “”, and struck out “For such tests furnished on or after , the fee schedule under subparagraph (A) shall not apply with respect to clinical diagnostic laboratory tests performed by a hospital laboratory for outpatients of such hospital.” which constituted second sentence.

Pub. L. 99–272, § 9303(a)(1)(A), substituted “” for “” and “” for “”.

Pub. L. 99–509, § 9339(a)(1)(C)Subsec. (h)(1)(D). , added subpar. (D).

Pub. L. 99–509, § 9339(b)(2)Subsec. (h)(2). , struck out “(or, effective , for the United States)” after “applicable region, State, or area”.

Pub. L. 99–509, § 9339(a)(1)(D), substituted “qualified hospital laboratory (as defined in paragraph (1)(D))” for “hospital laboratory”.

Pub. L. 99–272, § 9303(a)(1), substituted “” for “”, and inserted “(to become effective on January 1 of each year)” after “adjusted annually”.

Pub. L. 99–509, § 9339(c)(1)Subsec. (h)(3). , inserted subpar. (A) designation after “provide for and establish”, and added subpar. (B).

Pub. L. 99–272, § 9303(b)(2)Subsec. (h)(4). , designated existing provisions as subpar. (A) and added subpar. (B).

Pub. L. 99–272, § 9303(b)(3)Subsec. (h)(5)(C). , substituted “laboratory other than” for “laboratory which is independent of a physician’s office or”.

Pub. L. 99–509, § 9343(b)(2)Subsec. (i)(1). , inserted at end “The lists of procedures established under subparagraphs (A) and (B) shall be reviewed and updated not less often than every 2 years.”

Pub. L. 99–509, § 9343(e)(2)(B)Subsec. (i)(2). , inserted “80 percent of” before “a standard overhead amount” in introductory provisions of subpars. (A) and (B).

Pub. L. 99–509, § 9343(b)(1), substituted “shall be reviewed and updated not later than , and annually thereafter” for “shall be reviewed periodically” in concluding provisions of subpars. (A) and (B).

Pub. L. 99–509, § 9343(a)(1)(B)Subsec. (i)(3) to (5). , added par. (3) and redesignated former pars. (3) and (4) as (4) and (5), respectively.

lPub. L. 99–509, § 9320(e)(2)lSubsec. (). , added subsec. ().

Pub. L. 98–369, § 2354(b)(7)1984—Subsec. (a)(1). , struck out “and” at the end.

Pub. L. 98–369, § 2323(b)(1)section 1395x(s)(10)(A) of this titlesection 1395x(s)(10) of this titleSubsec. (a)(1)(B). , substituted “” for “”.

Pub. L. 98–369, § 2303(a)Subsec. (a)(1)(D). , amended subpar. (D) generally. Prior to amendment, subpar. (D) read as follows: “with respect to diagnostic tests performed in a laboratory for which payment is made under this part to the laboratory, the amounts paid shall be equal to 100 percent of the negotiated rate for such tests (as determined pursuant to subsection (h) of this section),”.

Pub. L. 98–369, § 2305(a)Subsec. (a)(1)(F), (G). , redesignated subpar. (G) as (F), and struck out former subpar. (F) which related to payment of reasonable charges for preadmission diagnostic services furnished by a physician to individuals enrolled under this part which are furnished in the outpatient department of a hospital within seven days of such individual’s admission to the same hospital or another hospital or furnished in the physician’s office within seven days of such individual’s admission to a hospital as an inpatient.

Pub. L. 98–369, § 2305(c)Subsec. (a)(2). , struck out “and in paragraph (5) of this subsection” after “of such section”.

Pub. L. 98–617, § 3(b)(2)Subsec. (a)(2)(A). , inserted “, or by another provider which demonstrates to the satisfaction of the Secretary that a significant portion of its patients are low-income (and requests that payment be made under this provision),”.

Pub. L. 98–369, § 2354(b)(5), realigned margin of subpar. (A).

Pub. L. 98–369, § 2321(b)(1), inserted in provision preceding cl. (i) “(other than durable medical equipment)”.

Pub. L. 98–369, § 2323(b)(1)section 1395x(s)(10)(A) of this titlesection 1395x(s)(10) of this title, substituted “” for “”.

Pub. L. 98–369, § 2354(b)(5)Subsec. (a)(2)(B). , realigned margin of subpar. (B).

Pub. L. 98–369, § 2321(b)(2), inserted in provision preceding cl. (i) “items and” after “to other”.

Pub. L. 98–369, § 2303(b)(1), inserted “or (D)” after “subparagraph (C)”.

Pub. L. 98–369, § 2308(b)(2)(B)Subsec. (a)(2)(B)(ii). , inserted “, or by another provider which demonstrates to the satisfaction of the Secretary that a significant portion of its patients are low-income (and requests that payment be made under this clause),”.

Pub. L. 98–369, § 2303(b)(2)Subsec. (a)(2)(D). –(4), added subpar. (D).

Pub. L. 98–369, § 2323(b)(1)section 1395x(s)(10)(A) of this titlesection 1395x(s)(10) of this titleSubsec. (a)(3). , substituted “” for “”.

Pub. L. 98–369, § 2305(b)section 1395x(s)(2)(C) of this titleSubsec. (a)(5). , struck out par. (5) which related to payment of reasonable costs for preadmission diagnostic services described in furnished to an individual by the outpatient department of a hospital within seven days of such individual’s admission to the same hospital as an inpatient or to another hospital.

Pub. L. 98–369, § 2323(b)(2)section 1395x(s)(10)(A) of this titlesection 1395x(s)(10) of this titleSubsec. (b)(1). , substituted “” for “”.

Pub. L. 98–369, § 2305(d)Subsec. (b)(3). , substituted “subsection (a)(1)(F)” for “subsection (a)(1)(G)”.

Pub. L. 98–369, § 2303(c)Subsec. (b)(4). , added par. (4).

Pub. L. 98–369, § 2321(d)(4)(A)section 1395zz of this titleSubsec. (f). , transferred subsec. (f) to part C of this subchapter and redesignated its provisions as section 1889 of the Social Security Act, which is classified to .

Pub. L. 98–369, § 2303(d)Subsec. (h). , amended subsec. (h) generally, substituting provisions directing the Secretary to establish fee schedules for clinical diagnostic laboratory tests at a percentage of the prevailing charge level and nominal fees to cover costs in collecting samples and authorizing the Secretary to make adjustments in the fee schedule, setting forth the recipients of payments, and authorizing the Secretary to establish a negotiated payment rate for provision authorizing the Secretary to establish a negotiated rate of payment with the laboratory which would be considered the full charge for such tests.

Pub. L. 98–617, § 3(b)(3)Subsec. (h)(5)(C). , inserted a comma before “under the procedure described in section”.

Pub. L. 98–369, § 2305(d)Subsec. (i)(3). , substituted “subsection (a)(1)(F)” for “subsection (a)(1)(G)”.

Pub. L. 98–369, § 2323(b)(4)Subsec. (k). , added subsec. (k).

Pub. L. 97–248, § 112(a)(1)section 1395x(s)(10) of this titlesection 1395u(b)(3)(B)(ii) of this title1982—Subsec. (a)(1)(B). , substituted provisions that with respect to items and services described in , amounts paid shall be 100 percent of reasonable charges for such items and services for provision that with respect to expenses incurred for radiological or pathological services for which payment could be made under this part, furnished to any inpatient of a hospital by a physician in field of radiology or pathology who had in effect an agreement with Secretary by which the physician agreed to accept an assignment (as provided for in ) for all physicians’ services furnished by him to hospital inpatients enrolled under this part, the amounts paid would be equal to 100 percent of the reasonable charges for such services.

Pub. L. 97–248, § 112(a)(2)section 1395x(s)(10) of this titleSubsec. (a)(1)(H). , (3), struck out subpar. (H) which provided that, with respect to items and services described in , the amount of benefits paid would be 100 percent of reasonable charges for such items and services.

Pub. L. 97–248, § 101(c)(2)section 1395ww of this titleSubsec. (a)(2)(B). , inserted “and except as may be provided in ”.

Pub. L. 97–248, § 112(b)section 1395u(b)(3)(B)(ii) of this titleSubsec. (b)(1). , struck out subpar. (A) provision that total amount of expenses shall not include expenses incurred for radiological or pathological services furnished an individual as an inpatient of a hospital by a physician in field of radiology or pathology who has an agreement with Secretary by which physician agrees to accept an assignment (as provided for in ) for all physicians’ services furnished by him to hospital inpatients under this part, and redesignated subpar. (B) provisions as par. (1).

Pub. L. 97–248, § 148(d)Subsec. (i)(1). , struck out requirement of consultation with National Professional Standards Review Council.

Pub. L. 97–248, § 117(a)(2)Subsec. (j). , added subsec. (j).

Pub. L. 97–35, § 2106(a)section 1395x(s)(10) of this titlesection 1395x(v) of this titlesection 1395f(b)(2) of this titlesection 1395x(s)(10) of this titlesection 1395x(v) of this title1981—Subsec. (a)(2)(A). , substituted provisions that with respect to home health services and to items and services described in , the lesser of reasonable cost of such services as determined under or customary charges with respect to such services, or if such services are furnished by a public provider of services free of charge or at nominal charges to the public, the amount determined in accordance with for provisions that with respect to home health services and to items and services described in , the reasonable cost of such services, as determined under .

Pub. L. 97–35, § 2106(a)section 1395cc(a)(2)(A) of this titleSubsec. (a)(2)(B). , substituted new formula in cls. (i) to (iii) with respect to other services for provisions providing for reasonable costs of such services less the amount a provider may charge as described in and that in no case may payment for such other services exceed 80 percent of such costs.

Pub. L. 97–35Subsec. (b). , §§ 2133(a), 2134(a), redesignated pars. (2) to (4) as (1) to (3), and struck out former par. (1), which provided that amount of deductible for such calendar year as so determined shall first be reduced by amount of any expenses incurred by such individual in last three months of preceding calendar year and applied toward such individual’s deductible under this section for such preceding year.

Pub. L. 97–35, § 2134(a), substituted “by a deductible of $75” for “by a deductible of $60”.

Pub. L. 96–499, § 943(a)section 1395u(b)(3)(B)(ii) of this title1980—Subsec. (a)(1)(B). , inserted “who has in effect an agreement with the Secretary by which the physician agrees to accept an assignment (as provided for in ) for all physicians’ services furnished by him to hospital inpatients enrolled under this part” after “radiology or pathology”.

Pub. L. 96–499, § 918(a)(4)Subsec. (a)(1)(D). , substituted “subsection (h)” for “subsection (g)”.

Pub. L. 96–499, § 932(a)(1)(B)Subsec. (a)(1)(F). , added subpar. (F).

Pub. L. 96–499, § 934(d)(1)Subsec. (a)(1)(G). , added subpar. (G).

Pub. L. 96–611, § 1(b)(1)(A)Subsec. (a)(1)(H). , (B), added subpar. (H).

Pub. L. 96–611, § 1(b)(1)(C)section 1395x(s)(10) of this titleSubsec. (a)(2). , inserted in subpar. (A) “and to items and services described in ”.

Pub. L. 96–499, § 942, authorized payment of reasonable cost of home health services and prescribed formulae for determining payment amounts for services other than home health services.

Pub. L. 96–611, § 1(b)(1)(D)section 1395x(s)(10) of this titleSubsec. (a)(3). , inserted “(other than for items and services described in )”.

Pub. L. 96–499, § 942section 1395k(a)(2) of this title, prescribed a formula for determining payment amounts for services described in subpars. (D) and (E) of .

Pub. L. 96–499, § 942Subsec. (a)(4), (5). , added pars. (4) and (5).

Pub. L. 96–611, § 1(b)(2)Subsec. (b)(2). , inserted “(A)” after “expenses incurred” and added subpar. (B).

Pub. L. 96–499, § 943(a)section 1395u(b)(3)(B)(ii) of this title, inserted “who has in effect an agreement with the Secretary by which the physician agrees to accept an assignment (as provided for in ) for all physicians’ services furnished by him to hospital inpatients enrolled under this part”.

Pub. L. 96–499, § 930(h)(2)Subsec. (b)(3). , added par. (3).

Pub. L. 96–499, § 934(d)(3)Subsec. (b)(4). , added par. (4).

Pub. L. 96–499, § 935(a)Subsec. (g). , substituted “$500” for “$100”.

Pub. L. 96–473section 279(b) of Pub. L. 92–603Subsec. (h). redesignated subsec. (g) as added by as (h), which for purposes of codification had been editorially set out as subsec. (h), thereby requiring no change in text. See 1972 Amendment note below.

Pub. L. 96–499, § 934(b)Subsec. (i). , added subsec. (i).

Pub. L. 95–292, § 4(b)(2)1978—Subsec. (a)(1)(E). , added subpar. (E).

Pub. L. 95–292, § 4(c)section 1395rr of this titleSubsec. (a)(2). , inserted “(unless otherwise specified in )” after “and with respect to other services” in provisions preceding subpar. (A).

Pub. L. 95–210, § 1(b)(2)section 1395k(a)(2) of this title1977—Subsec. (a)(2). , inserted parenthetical provisions preceding subpar. (A) excepting those services described in subpar. (D) of .

Pub. L. 95–210, § 1(b)(1)Subsec. (a)(3). , (3), (4), added par. (3).

Pub. L. 95–142Subsec. (f)(1). substituted provisions relating to determinations by Secretary with respect to presumptions regarding purchase price or practicality of buying or renting durable medical equipment, for provisions relating to purchase price of durable medical equipment authorized to be paid by Secretary.

Pub. L. 95–142Subsec. (f)(2). substituted provisions relating to waiver of coinsurance amount in purchase of used durable medical equipment, for provisions relating to reimbursement procedures established by Secretary in cases of rental of durable medical equipment.

Pub. L. 95–142Subsec. (f)(3), (4). added pars. (3) and (4).

Pub. L. 92–603, § 226(c)(2)section 1395mm of this title1972—Subsec. (a). , inserted reference to in provisions preceding par. (1).

Pub. L. 92–603Subsec. (a)(1). , §§ 211(c)(4), 279(a), added subpars. (C) and (D).

Pub. L. 92–603section 1395x(v) of this titleSubsec. (a)(2). , §§ 233(b), 251(a)(3), 299K(a), substituted subpars. (A) and (B) for provisions relating to the amount payable by reference to , added subpar. (C), and in provisions preceding subpar. (A), inserted “with respect to home health services, 100 percent, and with respect to other services,” before “80 percent”.

Pub. L. 92–603, § 204(a)Subsec. (b). , substituted “$60” for “$50”.

Pub. L. 92–603, § 245(d)Subsec. (f). , designated existing provisions as par. (1)(A) and added par. (1)(B) and (2).

Pub. L. 92–603, § 251(a)(2)Subsec. (g). , added subsec. (g).

Pub. L. 92–603, § 279(b)section 251(a)(2) of Pub. L. 92–603Subsec. (h). , added subsec. (h). Subsec. was in the original (g) and was changed to accommodate subsec. (g) as added by .

Pub. L. 90–248, § 131(a)(1)1968—Subsec. (a)(1). , (2), designated existing provisions as subpar. (A) and added subpar. (B).

Pub. L. 90–248section 1395e(a)(2)(A) of this titleSubsec. (b). , §§ 129(c)(7), 131(b), struck out reference in par. (1) to expenses regarded under former par. (2) as incurred for services furnished in last three months of preceding year, struck out former par. (2) which provided that amount of any deduction imposed by for outpatient hospital diagnostic services furnished in any calendar year is to be regarded as an incurred expense for such year; and added par. (2).

Pub. L. 90–248, § 135(c), inserted last sentence providing that there shall be a deductible equal to expenses incurred for first three pints of whole blood (or equivalent quantities of packed red blood cells as defined under regulations) furnished to an individual during a calendar year which deductible is to be appropriately reduced to extent that such blood has been replaced, and such blood will be deemed to have been replaced when institution or person furnishing such blood is given one pint of blood for each pint of blood (or equivalent quantities of packed red blood cells) furnished individual to which three pint deductible applies.

Pub. L. 90–248, § 129(c)(8)section 1395e of this titleSubsec. (d). , struck out reference to subsection (a)(2)(A) of .

Pub. L. 90–248, § 132(b)Subsec. (f). , added subsec. (f).

Statutory Notes and Related Subsidiaries

Effective Date of 2025 Amendment

Pub. L. 119–26, § 4139 Stat. 416Pub. L. 117–328, , , provided that the amendment made by section 4(2)(B)(v) is effective as if included in the enactment of .

Effective Date of 2022 Amendment

Pub. L. 117–328, div. FF, title IV, § 4121(c)136 Stat. 5903

“The amendments made by this section [amending this section and sections 1395u, 1395x, and 1395yy of this title] shall apply with respect to services furnished on or after .”
, , , provided that:

section 4124(b)(3) of Pub. L. 117–328section 4124(d) of Pub. L. 117–328Amendment by applicable with respect to items and services furnished on or after , see , set out as a note under section 1395k of this section.

Effective Date of 2021 Amendment

Pub. L. 117–7, § 2(a)(2)135 Stat. 252

Public Law 116–260“The amendments made by this subsection [amending this section] shall take effect as if included in the enactment of the Consolidated Appropriations Act, 2021 ().”
, , , provided that:

Effective Date of 2020 Amendment

Pub. L. 116–260, div. CC, title I, § 114(c)134 Stat. 2948

section 1395w–4 of this title“The amendments made by this section [amending this section and ] shall take effect on the date of the enactment of this Act [].”
, , , provided that:

Pub. L. 116–260, div. CC, title I, § 125(g)134 Stat. 2966

“The amendments made by this section [amending this section and sections 1395m, 1395x, 1395aa, 1395cc, and 1395dd of this title] shall apply to items and services furnished on or after .”
, , , provided that:

Pub. L. 116–136, div. A, title III, § 3713(d)134 Stat. 424

42 U.S.C. 262“The amendments made by this section [amending this section and sections 1395w–22 and 1395x of this title] shall take effect on the date of enactment of this Act [] and shall apply with respect to a COVID–19 vaccine beginning on the date that such vaccine is licensed under section 351 of the Public Health Service Act ().”
, , , provided that:

Effective Date of 2016 Amendment

Pub. L. 114–255, div. A, title V, § 5012(d)130 Stat. 1202Pub. L. 115–123, div. E, title IV, § 50401(b)(2)132 Stat. 217

“The amendments made by this section [amending this section and sections 1395m, 1395u, and 1395x of this title] shall apply to items and services furnished on or after , except that the amendments made by paragraphs (1) and (2) of subsection (c) shall apply to items and services furnished on or after .”
, , , as amended by , , , provided that:

Pub. L. 114–255, div. C, title XVI, § 16001(b)130 Stat. 1325

Public Law 114–74“The amendments made by this section [amending this section] shall be effective as if included in the enactment of section 603 of the Bipartisan Budget Act of 2015 ().”
, , , provided that:

Pub. L. 114–255, div. C, title XVI, § 16002(c)130 Stat. 1326

Public Law 114–74“The amendments made by this section [amending this section] shall be effective as if included in the enactment of section 603 of the Bipartisan Budget Act of 2015 ().”
, , , provided that:

Effective Date of 2015 Amendment

Pub. L. 114–113, div. O, title V, § 504(d)129 Stat. 3023

“The amendments made by this section [amending this section and sections 1395m and 1395x of this title] shall apply to items furnished on or after .”
, , , provided that:

Pub. L. 114–10, title II, § 202(b)(2)129 Stat. 144

42 U.S.C. 1395l“The amendments made by this subsection [amending this section] shall apply with respect to requests described in section 1833(g)(5)(C)(i) of the Social Security Act ((g)(5)(C)(i)) with respect to which the Secretary of Health and Human Services has not conducted medical review under such section by a date (not later than 90 days after the date of the enactment of this Act []) specified by the Secretary.”
, , , provided that:

Effective Date of 2012 Amendment

Pub. L. 112–96, title III, § 3005(e)126 Stat. 189

42 U.S.C. 1395l“The requirement of subparagraph (B) of section 1833(g)(5) of the Social Security Act ((g)(5)), as added by subsection (a), shall apply to services furnished on or after .”
, , , provided that:

Effective Date of 2010 Amendment

Pub. L. 111–148, title IV, § 4103(e)124 Stat. 557

“The amendments made by this section [amending this section and sections 1395w–4, 1395x, and 1395y of this title] shall apply to services furnished on or after .”
, , , provided that:

Pub. L. 111–148, title IV, § 4104(d)124 Stat. 558

section 1395x of this title“The amendments made by this section [amending this section and ] shall apply to items and services furnished on or after .”
, , , provided that:

Effective Date of 2008 Amendment

Pub. L. 110–275, title I, § 101(c)122 Stat. 2498

“The amendments made by this section [amending this section and sections 1395x and 1395y of this title] shall apply to services furnished on or after .”
, , , provided that:

Pub. L. 110–275section 143(c) of Pub. L. 110–275section 1395k of this titleAmendment by section 143(b)(2), (3), of applicable to services furnished on or after , see , set out as a note under .

Pub. L. 110–275, title I, § 145(a)(3)122 Stat. 2547

section 1395w–3 of this title“The amendments made by this subsection [amending this section and ] shall take effect on the date of the enactment of this Act [].”
, , , provided that:

Effective Date of 2006 Amendment

Pub. L. 109–432, div. B, title I, § 109(c)120 Stat. 2985

section 1395ww of this title“The amendments made by this section [amending this section and ] shall apply to payment for services furnished on or after .”
, , , provided that:

Pub. L. 109–171, title V, § 5112(f)120 Stat. 44

“The amendments made by this section [amending this section and sections 1395w–4, 1395x, and 1395y of this title] shall apply to services furnished on or after .”
, , , provided that:

Pub. L. 109–171, title V, § 5113(c)120 Stat. 44

section 1395m of this title“The amendments made by this section [amending this section and ] shall apply to services furnished on or after .”
, , , provided that:

Effective Date of 2003 Amendment

section 237(a) of Pub. L. 108–173section 237(e) of Pub. L. 108–173section 1320a–7b of this titleAmendment by applicable to services provided on or after , and contract years beginning on or after such date, see , set out as a note under .

Pub. L. 108–173, title IV, § 411(a)(2)117 Stat. 2274

“The amendment made by paragraph (1)(B) [amending this section] shall apply with respect to cost reporting periods beginning on and after .”
, , , provided that:

Pub. L. 108–173, title IV, § 413(b)(2)117 Stat. 2277

“The amendments made by paragraph (1) [amending this section] shall apply to physicians’ services furnished on or after .”
, , , provided that:

Pub. L. 108–173, title VI, § 614(c)117 Stat. 2306

“The amendments made by this section [amending this section] shall apply—
“(1)
in the case of screening mammography, to services furnished on or after the date of the enactment of this Act []; and
“(2)
in the case of diagnostic mammography, to services furnished on or after .”
, , , provided that:

Pub. L. 108–173, title VI, § 621(a)(6)117 Stat. 2310

“The amendments made by this subsection [amending this section] shall apply to items and services furnished on or after .”
, , , provided that:

Pub. L. 108–173, title VI, § 627(c)117 Stat. 2321

“The amendments made by this section [amending this section and sections 1395m and 1395u of this title] shall apply to items furnished on or after .”
, , , provided that:

Pub. L. 108–173, title VI, § 642(c)117 Stat. 2322

section 1395x of this title“The amendments made by this section [amending this section and ] shall apply to items furnished administered [sic] on or after .”
, , , provided that:

Effective Date of 2000 Amendment

Pub. L. 106–554, § 1(a)(6) [title I, § 105(e)]114 Stat. 2763

“The amendments made by this section [amending this section and sections 1395u and 1395x of this title] shall apply to services furnished on or after .”
, , , 2763A–472, provided that:

Pub. L. 106–554, § 1(a)(6) [title I, § 111(a)(2)]114 Stat. 2763

“The amendment made by paragraph (1) [amending this section] shall apply with respect to services furnished on or after .”
, , , 2763A–473, provided that:

Pub. L. 106–554, § 1(a)(6) [title II, § 201(c)]114 Stat. 2763

“The amendment made—
“(1)
section 1395m of this titlePub. L. 106–113, § 1000(a)(6) by subsection (a) [amending ] shall apply to services furnished on or after the date of the enactment of BBRA [, approved ];
“(2)
113 Stat. 1501Pub. L. 106–113, § 1000(a)(6) [title IV, § 403(e)(1)] by subsection (b)(1) [amending this section] shall apply as if included in the enactment of section 403(e)(1) of BBRA (A–371) []; and
“(3)
section 1395m of this title113 Stat. 1501Pub. L. 106–113, § 1000(a)(6) [title IV, § 403(d)(2)]section 1395m of this title by subsection (b)(2) [amending provisions set out as a note under ] shall apply as if included in the enactment of section 403(d)(2) of BBRA (A–371) [, set out as a note under ].”
, , , 2763A–481, provided that:

Pub. L. 106–554, § 1(a)(6) [title II, § 205(c)]114 Stat. 2763

section 1395m of this title“The amendments made by this section [amending this section and ] shall apply to services furnished on or after the date of the enactment of this Act [].”
, , , 2763A–483, provided that:

Pub. L. 106–554, § 1(a)(6) [title II, § 223(e)]114 Stat. 2763

section 1395m of this title“The amendments made by subsections (b) and (c) [amending this section and ] shall be effective for services furnished on or after .”
, , , 2763A–490, provided that:

Pub. L. 106–554, § 1(a)(6) [title II, § 224(b)]114 Stat. 2763

“The amendment made by subsection (a) [amending this section] shall apply to services furnished on or after .”
, , , 2763A–490, provided that:

Pub. L. 106–554, § 1(a)(6) [title IV, § 401(b)(2)]114 Stat. 2763

Pub. L. 105–33“The amendments made by paragraph (1) [amending this section] shall take effect as if included in the enactment of BBA [].”
, , , 2763A–503, provided that:

Pub. L. 106–554, § 1(a)(6) [title IV, § 402(c)]114 Stat. 2763

“The amendments made by this section [amending this section] take effect on the date of the enactment of this Act [].”
, , , 2763A–505, provided that:

Pub. L. 106–554, § 1(a)(6) [title IV, § 403(b)]114 Stat. 2763

Pub. L. 106–113, § 1000(a)(6)“The amendment made by subsection (a) [amending this section] shall take effect as if included in the enactment of BBRA [].”
, , , 2763A–506, provided that:

Pub. L. 106–554, § 1(a)(6) [title IV, § 405(b)]114 Stat. 2763

Pub. L. 106–113, § 1000(a)(6) [title II, § 202]113 Stat. 1501“The amendments made by subsection (a) [amending this section] shall apply as if included in the enactment of section 202 of BBRA [] (A–342).”
, , , 2763A–507, provided that:

Pub. L. 106–554, § 1(a)(6) [title IV, § 406(b)]114 Stat. 2763

“The amendment made by subsection (a) [amending this section] shall apply to devices furnished on or after .”
, , , 2763A–508, provided that:

Pub. L. 106–554, § 1(a)(6) [title IV, § 430(c)]114 Stat. 2763

section 1395x of this title“The amendments made by this section [amending this section and ] apply to items and services furnished on or after .”
, , , 2763A–525, provided that:

Effective Date of 1999 Amendment

Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 201(h)(2)]113 Stat. 1536

“The Secretary of Health and Human Services shall first conduct the annual review under the amendment made by paragraph (1)(A) [amending this section] in 2001 for application in 2002 and the amendment made by paragraph (1)(B) [amending this section] takes effect on the date of the enactment of this Act [].”
, , , 1501A–340, provided that:

Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 201(m)]113 Stat. 1536

Pub. L. 105–33“Except as provided in this section, the amendments made by this section [amending this section and sections 1395m and 1395x of this title] shall be effective as if included in the enactment of BBA [the Balanced Budget Act of 1997, ].”
, , , 1501A–341, provided that:

Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 202(b)]113 Stat. 1536

Pub. L. 105–33“The amendments made by this section [amending this section] shall be effective as if included in the enactment of BBA [the Balanced Budget Act of 1997, ].”
, , , 1501A–344, provided that:

Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 204(c)]113 Stat. 1536

Pub. L. 105–3342 U.S.C. 1395l“The amendments made by this section [amending this section] apply as if included in the enactment of BBA [the Balanced Budget Act of 1997, ] and shall only apply to procedures performed for which payment is made on the basis of the prospective payment system under section 1833(t) of the Social Security Act [(t)].”
, , , 1501A–345, provided that:

Pub. L. 106–113Pub. L. 105–33Pub. L. 106–113section 1395d of this titleAmendment by section 1000(a)(6) [title III, § 321(g)(2), (k)(2)] of effective as if included in the enactment of the Balanced Budget Act of 1997, , except as otherwise provided, see section 1000(a)(6) [title III, § 321(m)] of , set out as a note under .

Pub. L. 106–113Pub. L. 106–113section 1395i–4 of this titleAmendment by section 1000(a)(6) [title IV, § 401(b)(1)] of effective , see section 1000(a)(6) [title IV, § 401(c)] of , set out as a note under .

Pub. L. 106–113, div. B, § 1000(a)(6) [title IV, § 403(e)(2)]113 Stat. 1536

“The amendments made by paragraph (1) [amending this section] shall apply to services furnished on or after the date of the enactment of this Act [].”
, , , 1501A–371, provided that:

Effective Date of 1997 Amendment

Pub. L. 105–33, title IV, § 4002(j)(1)(B)111 Stat. 330

“The amendment made by subparagraph (A) [amending this section] applies to new contracts entered into after the date of enactment of this Act [] and, with respect to contracts in effect as of such date, shall apply to payment for services furnished after .”
, , , provided that:

Pub. L. 105–33, title IV, § 4101(d)111 Stat. 360

section 1395m of this title“The amendments made by this section [amending this section and ] shall apply to items and services furnished on or after .”
, , , provided that:

Pub. L. 105–33, title IV, § 4102(e)111 Stat. 361

“The amendments made by this section [amending this section and sections 1395w–4, 1395x, and 1395y of this title] shall apply to items and services furnished on or after .”
, , , provided that:

Pub. L. 105–33, title IV, § 4103(e)111 Stat. 362

“The amendments made by this section [amending this section and sections 1395w–4, 1395x, and 1395y of this title] shall apply to items and services furnished on or after .”
, , , provided that:

Pub. L. 105–33, title IV, § 4104(e)111 Stat. 366

“The amendments made by this section [amending this section and sections 1395m, 1395w–4, 1395x, and 1395y of this title] shall apply to items and services furnished on or after .”
, , , provided that:

section 4201(c)(1) of Pub. L. 105–33section 4201(d) of Pub. L. 105–33section 1395f of this titleAmendment by applicable to services furnished on or after , see , set out as a note under .

Pub. L. 105–33, title IV, § 4205(a)(1)(B)111 Stat. 376

“The amendment made by subparagraph (A) [amending this section] applies to services furnished on or after .”
, , , provided that:

Pub. L. 105–33, title IV, § 4315(c)111 Stat. 390

section 1395u of this title“The amendments made by this section [amending this section and ] to the extent such amendments substitute fee schedules for reasonable charges, shall apply to particular services as of the date specified by the Secretary of Health and Human Services.”
, , , provided that:

section 4432(b)(5)(C) of Pub. L. 105–33section 4432(d) of Pub. L. 105–33section 1395i–3 of this titleAmendment by applicable to items and services furnished on or after , see , set out as a note under .

section 4511(b) of Pub. L. 105–33section 4511(e) of Pub. L. 105–33section 1395k of this titleAmendment by applicable with respect to services furnished and supplies provided on and after , see , set out as a note under .

Pub. L. 105–33, title IV, § 4512(d)111 Stat. 444

“The amendments made by this section [amending this section and sections 1395u and 1395x of this title] shall apply with respect to services furnished and supplies provided on and after .”
, , , provided that:

Pub. L. 105–33, title IV, § 4521(c)111 Stat. 444

“The amendments made by this section [amending this section] shall apply to services furnished during portions of cost reporting periods occurring on or after .”
, , , provided that:

Pub. L. 105–33, title IV, § 4523(d)(1)(A)(ii)111 Stat. 449

“The amendment made by clause (i) [amending this section] shall apply to services furnished on or after .”
, , , provided that:

Pub. L. 105–33, title IV, § 4531(b)(3)111 Stat. 452

section 1395m of this title“The amendments made by this subsection [amending this section and ] shall apply to services furnished on or after .”
, , , provided that:

Pub. L. 105–33, title IV, § 4541(e)111 Stat. 457

“(1)
42 U.S.C. 1395m(k)42 U.S.C. 1395l The amendments made by subsections (a)(1), (a)(2), and (b) [amending this section and sections 1395m and 1395y of this title] apply to services furnished on or after , including portions of cost reporting periods occurring on or after such date, except that section 1834(k) of the Social Security Act [] (as added by subsection (a)(2)) shall not apply to services described in section 1833(a)(8)(B) of such Act [(a)(8)(B)] (as added by subsection (a)(1)) that are furnished during 1998.
“(2)
section 1395cc of this title The amendments made by subsections (a)(3) and (c) [amending this section and ] apply to services furnished on or after .
“(3)
The amendments made by subsection (d)(1) [amending this section] apply to expenses incurred on or after .”
, , , provided that:

Pub. L. 105–33, title IV, § 4556(d)111 Stat. 463

section 1395u of this title“The amendments made by subsections (a) and (b) [amending this section and ] shall apply to drugs and biologicals furnished on or after .”
, , , provided that:

section 4603(c)(2)(A) of Pub. L. 105–33section 4603(d) of Pub. L. 105–33section 1395fff of this titleAmendment by applicable to cost reporting periods beginning on or after , except as otherwise provided, see , set out as an Effective Date note under .

Effective Date of 1994 Amendment

Pub. L. 103–432, title I, § 123(f)(1)108 Stat. 4412

“(1)

Enforcement; miscellaneous and technical amendments .—

section 1395w–4 of this titlesection 1395w–4 of this titleThe amendments made by subsections (a) and (e) [amending this section and ] shall apply to services furnished on or after the date of the enactment of this Act []; except that the amendments made by subsection (a) [amending ] shall not apply to services of a nonparticipating supplier or other person furnished before .
“(2)

Practitioners .—

section 1395u of this titleThe amendments made by subsection (b) [amending this section and ] shall apply to services furnished on or after .”
, (2), , , provided that:

Pub. L. 103–432, title I, § 141(c)(2)108 Stat. 4425

Pub. L. 101–508“The amendments made by paragraph (1) [amending this section] shall take effect as if included in the enactment of OBRA–1990 [].”
, , , provided that:

Pub. L. 103–432Pub. L. 101–508section 147(g) of Pub. L. 103–432section 1320a–3a of this titleAmendment by section 147(a), (e)(2), (3), (f)(6)(C), (D) of effective as if included in the enactment of , see , set out as a note under .

Pub. L. 103–432, title I, § 147(d)(1)108 Stat. 4429Pub. L. 101–239, (2), , , provided that the amendment made by that section is effective as if included in the enactment of .

section 156(a)(2)(B) of Pub. L. 103–432section 156(a)(3) of Pub. L. 103–432section 1320c–3 of this titleAmendment by applicable to services provided on or after , see , set out as a note under .

Effective Date of 1993 Amendment

Pub. L. 103–66, title XIII, § 13532(b)107 Stat. 587

“The amendments made by subsection (a) [amending this section] shall apply to portions of cost reporting periods beginning on or after .”
, , , provided that:

Pub. L. 103–66, title XIII, § 13544(b)(3)107 Stat. 590

section 1395m of this title“The amendments made by this subsection [amending this section and ] shall apply to items furnished on or after .”
, , , provided that:

Pub. L. 103–66, title XIII, § 13555(b)107 Stat. 592

“The amendment made by subsection (a) [amending this section] shall apply to services furnished on or after .”
, , , provided that:

Effective Date of 1990 Amendment

Pub. L. 101–508, title IV, § 4104(d)104 Stat. 1388–59

“The amendments made by this section [amending this section and sections 1395m and 1395w–4 of this title] shall apply to services furnished on or after .”
, , , provided that:

Pub. L. 101–508section 4153(a)(3) of Pub. L. 101–508section 1395k of this titleAmendment by section 4153(a)(2)(B), (C) of applicable to items furnished on or after , see , set out as a note under .

Pub. L. 101–508, title IV, § 4154(b)(2)104 Stat. 1388–85

“The amendments made by paragraph (1) [amending this section] shall apply to tests furnished on or after .”
, , , provided that:

Pub. L. 101–508, title IV, § 4154(c)(2)104 Stat. 1388–85

Pub. L. 99–272Pub. L. 100–203“The amendment made by paragraph (1)(A) [amending this section] shall take effect as if included in the enactment of the Consolidated Omnibus Budget Reconciliation Act of 1985 [], and the amendment made by paragraph (1)(B) [amending this section] shall take effect as if included in the enactment of the Omnibus Budget Reconciliation Act of 1987 [].”
, , , provided that:

Pub. L. 101–508, title IV, § 4154(e)(5)104 Stat. 1388–86Pub. L. 103–432, title I, § 147(f)(2)108 Stat. 4431

section 1395w–2 of this titlePub. L. 101–239“The amendments made by paragraphs (1)(A), (1)(B), (2), and (4) [amending this section, , and provisions set out as a note below] shall take effect as if included in the enactment of the Omnibus Budget Reconciliation Act of 1989 [], and the amendment made by paragraph (1)(C) [amending this section] shall take effect .”
, , , as amended by , , , provided that:

Pub. L. 101–508section 4155(e) of Pub. L. 101–508section 1395k of this titleAmendment by section 4155(b)(2), (3) of applicable to services furnished on or after , see , set out as a note under .

section 4161(a)(3)(B) of Pub. L. 101–508section 4161(a)(8) of Pub. L. 101–508section 1395k of this titleAmendment by applicable to services furnished on or after , see , set out as a note under .

Pub. L. 101–508, title IV, § 4163(e)104 Stat. 1388–100Pub. L. 103–432, title I, § 147(f)(5)(B)108 Stat. 4431

section 1395y of this title“Except as provided in subsection (d)(3) [enacting provisions set out as a note under ], the amendments made by this section [amending this section and sections 1395m, 1395x, 1395y, 1395z, 1395aa, and 1395bb of this title] shall apply to screening mammography performed on or after .”
, , , as amended by , , , provided that:

Pub. L. 101–508, title IV, § 4206(e)(2)104 Stat. 1388–117

section 1395mm of this title42 U.S.C. 1395mm42 U.S.C. 1395l“The amendments made by subsection (b) [amending this section and ] shall apply to contracts under section 1876 of the Social Security Act [] and payments under section 1833(a)(1)(A) of such Act [(a)(1)(A)] as of first day of the first month beginning more than 1 year after the date of the enactment of this Act [].”
, , , provided that:

Effective Date of 1989 Amendment

Pub. L. 101–239, title VI, § 6102(c)(2)103 Stat. 2185

“The amendments made by paragraph (1) [amending this section] shall apply to services furnished on or after .”
, , , provided that:

Pub. L. 101–239, title VI, § 6102(f)(3)103 Stat. 2189

section 1395m of this title“The amendments made by this subsection [amending this section and ] shall apply to services furnished on or after .”
, , , provided that:

Pub. L. 101–239, title VI, § 6102(g)103 Stat. 2189

section 1395w–4 of this title“Except as otherwise provided in this section, this section, and the amendments made by this section [enacting , amending this section and sections 1395m, 1395u, and 1395rr of this title, and enacting provisions set out as notes under this section and sections 1395m, 1395u, and 1395w–4 of this title], shall take effect on the date of the enactment of this Act [].”
, , , provided that:

Pub. L. 101–239, title VI, § 6111(b)(2)103 Stat. 2214Pub. L. 101–508, title IV, § 4154(e)(4)104 Stat. 1388–86

“The amendment made by paragraph (1) [amending this section] shall apply with respect to clinical diagnostic laboratory tests performed on or after .”
, , , as amended by , , , provided that:

Pub. L. 101–239, title VI, § 6113(e)103 Stat. 2217

section 1395x of this title“The amendments made by this section [amending this section and ], and the provisions of subsection (c) [set out below], shall apply to services furnished on or after , and the amendments made by subsection (d) [amending this section] shall apply to expenses incurred in a year beginning with 1990.”
, , , provided that:

Pub. L. 101–239, title VI, § 6131(c)103 Stat. 2221

“(1)
section 1395x of this title The amendments made by this section [amending this section and ] shall apply with respect to therapeutic shoes and inserts furnished on or after .
“(2)
o42 U.S.C. 1395lo In applying the amendments made by this section, the increase under subparagraph (C) of section 1833()(2) of the Social Security Act [()(2)(C)] shall apply to the dollar amounts specified under subparagraph (A) of such section (as amended by this section) in the same manner as the increase would have applied to the dollar amounts specified under subparagraph (A) of such section (as in effect before the date of the enactment of this Act []).”
, , , provided that:

Pub. L. 101–239, title VI, § 6133(b)103 Stat. 2222

“The amendment made by subsection (a) [amending this section] shall apply to services furnished on or after .”
, , , provided that:

section 6204(b) of Pub. L. 101–239section 6204(c) of Pub. L. 101–239section 1395nn of this titleAmendment by effective with respect to referrals made on or after , see , set out as a note under .

section 201(a) of Pub. L. 101–234section 201(c) of Pub. L. 101–234section 1320a–7a of this titleAmendment by effective , see , set out as a note under .

section 202(a) of Pub. L. 101–234section 202(b) of Pub. L. 101–234section 401 of this titleAmendment by effective , see , set out as a note under .

Effective Date of 1988 Amendment

Pub. L. 100–647, title VIII, § 8422(b)102 Stat. 3802

Pub. L. 99–509“The amendment made by subsection (a) [amending this section] shall become effective as if included in the amendment made by section 9320(e)(2) of the Omnibus Budget Reconciliation Act of 1986 [].”
, , , provided that:

Pub. L. 100–485Pub. L. 100–360section 608(g) of Pub. L. 100–485section 704 of this titleAmendment by effective as if included in the enactment of the Medicare Catastrophic Coverage Act of 1988, , see , set out as a note under .

Pub. L. 100–360section 202(m)(1) of Pub. L. 100–360section 1395u of this titleAmendment by section 202(b)(1)–(3) of applicable to items dispensed on or after , see , set out as a note under .

Pub. L. 100–360section 203(g) of Pub. L. 100–360section 1320c–3 of this titleAmendment by section 203(c)(1)(A)–(E) of applicable to items and services furnished on or after , see , set out as a note under .

section 204(d)(1) of Pub. L. 100–360section 204(e) of Pub. L. 100–360section 1395m of this titleAmendment by applicable to screening mammography performed on or after , see , set out as a note under .

section 205(c) of Pub. L. 100–360section 205(f) of Pub. L. 100–360section 1395k of this titleAmendment by applicable to items and services furnished on or after , see , set out as a note under .

section 411 of Pub. L. 100–360Pub. L. 100–360Pub. L. 100–203Pub. L. 100–203section 411(a) of Pub. L. 100–360section 106 of Title 1Except as specifically provided in , amendment by section 411(f)(2)(D), (8)(B)(i), (C), (12)(A), (14), (g)(1)(E), (2)(D), (E), (3)(A)–(F), (4)(C), (5), (h)(1)(A), (3)(B), (4)(B), (C), (7)(C), (D), (F), (i)(3), (4)(B)–(C)(ii), (iv), and (vi) of , as it relates to a provision in the Omnibus Budget Reconciliation Act of 1987, , effective as if included in the enactment of that provision in , see , set out as a Reference to OBRA; Effective Date note under , General Provisions.

Effective Date of 1987 Amendment

Pub. L. 100–203, title IV, § 4043(c)101 Stat. 1330–86

42 U.S.C. 1395ww(d)(2)(D)“The amendments made by this [sic] subsection (a) [amending this section] shall apply with respect to services furnished in a rural area (as defined in section 1886(d)(2)(D) of the Social Security Act []) on or after , and to other services furnished on or after .”
, , , provided that:

section 4045(c)(2)(A) of Pub. L. 100–203section 4045(d) of Pub. L. 100–203section 1395u of this titleAmendment by applicable to items and services furnished on or after , see , set out as a note under .

section 4049(a)(1) of Pub. L. 100–203section 4049(b)(2) of Pub. L. 100–203section 1395m of this titleAmendment by applicable to services performed on or after , see , as amended, set out as a note under .

Pub. L. 100–203, title IV, § 4055(b)Pub. L. 100–360, title IV, § 411(f)(12)(A)102 Stat. 781

“The amendments made by subsection (a) [amending this section] shall apply to services furnished on or after .”
, formerly § 4054(b), as added and renumbered by , (14), , , provided that:

section 4062(d)(3) of Pub. L. 100–203section 4062(e) of Pub. L. 100–203section 1395f of this titleAmendment by applicable to covered items (other than oxygen and oxygen equipment) furnished on or after , and to oxygen and oxygen equipment furnished on or after , see , as amended, set out as a note under .

Pub. L. 100–203, title IV, § 4063(c)101 Stat. 1330–110

section 1395u of this title“The amendments made by this section [amending this section and ] shall apply to items furnished on or after .”
, , , provided that:

Pub. L. 100–203, title IV, § 4064(b)(3)101 Stat. 1330–110

“The amendments made by paragraphs (1) and (2) [amending this section] shall apply with respect to services furnished on or after .”
, , , provided that:

Pub. L. 100–203, title IV, § 4064(c)(2)Pub. L. 100–360, title IV, § 411(g)(3)(F)102 Stat. 784

“The amendment made by paragraph (1) [amending this section] shall apply with respect to diagnostic laboratory tests furnished on or after .”
, as added by , , , provided that:

Pub. L. 100–203, title IV, § 4066(c)101 Stat. 1330–113

“The amendments made by subsection (a) [amending this section] shall apply with respect to outpatient hospital radiology services furnished on or after , and other diagnostic procedures performed on or after .”
, , , provided that:

Pub. L. 100–203, title IV, § 4067(c)101 Stat. 1330–113

“The amendment made by subsection (a) [amending this section] shall apply to services furnished on or after .”
, , , provided that:

Pub. L. 100–203, title IV, § 4068(c)101 Stat. 1330–114

Pub. L. 99–509“The amendments made by subsection (a) [amending this section] shall be effective as if included in the amendment made by section 9343(a)(1)(B) of the Omnibus Budget Reconciliation Act of 1986 [].”
, , , provided that:

Pub. L. 100–203, title IV, § 4070(c)(1)101 Stat. 1330–115

42 U.S.C. 1395l“The amendment made by subsection (a)(1) [amending this section] shall apply with respect to calendar years beginning with 1988; except that with respect to 1988, any reference in section 1833(c) of the Social Security Act [(c)], as amended by subsection (a), to ‘$1375.00’ is deemed a reference to ‘$562.50’. The amendment made by subsection (a)(2) [amending this section] shall apply to services furnished on or after .”
, , , provided that:

section 4072(b) of Pub. L. 100–203section 4072(e) of Pub. L. 100–203section 1395x of this titleFor effective date of amendment by , see , set out as a note under .

section 4073(b) of Pub. L. 100–203section 4073(e) of Pub. L. 100–203section 1395k of this titleAmendment by effective with respect to services performed on or after , see , set out as a note under .

Pub. L. 100–203section 4077(b)(5) of Pub. L. 100–203section 1395k of this titleAmendment by section 4077(b)(2), (3) of effective with respect to services performed on or after , see , set out as a note under .

Pub. L. 100–203, title IV, § 4084(b)101 Stat. 1330–129

Pub. L. 99–509“The amendments made by subsection (a) [amending this section] shall apply as if included in the amendment made by section 9320(e)(2) of the Omnibus Budget Reconciliation Act of 1986 [].”
, , , provided that:

Pub. L. 100–203, title IV, § 4084(c)(3)Pub. L. 100–360, title IV, § 411(i)(3)102 Stat. 788

section 1395x of this title“The amendments made by this subsection [amending this section and ] shall apply to services furnished after .”
, as added by , , , provided that:

Pub. L. 100–203, title IV, § 4085(b)(2)101 Stat. 1330–130

“The amendment made by paragraph (1) [amending this section] shall apply to procedures performed on or after .”
, , , provided that:

Pub. L. 100–203, title IV, § 4085(i)(21)101 Stat. 1330–133section 9343 of Pub. L. 99–509section 4085(i)(21)(D) of Pub. L. 100–203Pub. L. 99–509, , , provided that the amendment to by , amending this section and provisions set out as an Effective Date of 1986 Amendments note below, is effective as if included in the enactment of .

Effective Date of 1986 Amendment

Pub. L. 99–509Pub. L. 99–509section 1395k of this titleAmendment by section 9320(e)(1), (2) of applicable to services furnished on or after , with exceptions for hospitals located in rural areas which meet certain requirements related to certified registered nurse anesthetists, see section 9320(i), (k) of , as amended, set out as notes under .

section 9337(b) of Pub. L. 99–509section 9337(e) of Pub. L. 99–509section 1395k of this titleAmendment by applicable to expenses incurred for outpatient occupational therapy services furnished on or after , see , set out as a note under .

Pub. L. 99–509, title IX, § 9339(a)(2)100 Stat. 2036

“The amendments made by this subsection [amending this section] apply to clinical diagnostic laboratory tests performed on or after .”
, , , provided that:

Pub. L. 99–509, title IX, § 9339(c)(2)100 Stat. 2037

“The amendment made by paragraph (1) [amending this section] shall apply to samples collected on or after .”
, , , provided that:

Pub. L. 99–509, title IX, § 9343(h)100 Stat. 2042Pub. L. 100–203, title IV, § 4085(i)(21)(D)(ii)101 Stat. 1330–134Pub. L. 100–360, title IV, § 411(i)(4)(C)(v)102 Stat. 789

“(1)
The amendments made by subsection (a)(1) [amending this section] shall apply to cost reporting periods beginning on or after .
“(2)
The amendments made by subsections (b)(1) and (c) [amending this section and sections 1395y and 1395cc of this title] shall apply to services furnished after .
“(3)
The Secretary of Health and Human Services shall first provide, under the amendment made by subsection (b)(2) [amending this section], for the review and update of procedure lists within 6 months after the date of the enactment of this Act [].
“(4)
section 1320c–3 of this title The amendments made by subsection (d) [amending ] shall apply to contracts entered into or renewed after .”
, , , as amended by , (iii), , ; , , , provided that:

Pub. L. 99–272, title IX, § 9303(a)(2)100 Stat. 188

“The amendments made by paragraph (1) [amending this section] shall apply to clinical laboratory diagnostic tests performed on or after .”
, , , provided that:

Pub. L. 99–272, title IX, § 9303(b)(5)(A)100 Stat. 189

“(A)
The amendments made by paragraphs (1) and (2) [amending this section] shall apply to clinical diagnostic laboratory tests performed on or after .
“(B)
The amendment made by paragraph (3) [amending this section] shall apply to clinical diagnostic laboratory tests performed on or after .”
, (B), , , provided that:

Effective Date of 1984 Amendment

Pub. L. 98–617Pub. L. 98–369section 3(c) of Pub. L. 98–617section 1395f of this titleAmendment by effective as if originally included in the Deficit Reduction Act of 1984, , see , set out as a note under .

Pub. L. 98–369, div. B, title III, § 2303(j)98 Stat. 1067

“(1)
section 1395u of this title Except as provided in paragraphs (2) and (3), the amendments made by this section [amending this section and sections 1395u, 1395cc, 1396a, and 1396b of this title and enacting provisions set out as notes under this section and ] shall apply to clinical diagnostic laboratory tests furnished on or after .
“(2)
section 1396b of this title The amendments made by subsection (g)(2) [amending ] shall apply to payments for calendar quarters beginning on or after .
“(3)
section 602(k) of Pub. L. 98–21section 1395y of this title42 U.S.C. 1395j42 U.S.C. 1395u(b)(3)(B)(ii)42 U.S.C. 1395gg(f)(1)42 U.S.C. 1395l The amendments made by this section shall not apply to clinical diagnostic laboratory tests furnished to inpatients of a provider operating under a waiver granted pursuant to section 602(k) of the Social Security Amendments of 1983 [, set out as a note under ]. Payment for such services shall be made under part B of title XVIII of the Social Security Act [ et seq.] at 80 percent (or 100 percent in the case of such tests for which payment is made on the basis of an assignment described in section 1842(b)(3)(B)(ii) of the Social Security Act [] or under the procedure described in section 1870(f)(1) of such Act []) of the reasonable charge for such service. The deductible under section 1833(b) of such Act [(b)] shall not apply to such tests if payment is made on the basis of such an assignment or procedure.”
, , , provided that:

Pub. L. 98–369, div. B, title III, § 2305(e)98 Stat. 1070

“The amendments made by this section [amending this section and enacting provisions set out below] shall apply to services performed after the date of the enactment of this Act [].”
, , , provided that:

Pub. L. 98–369section 2321(g) of Pub. L. 98–369section 1395f of this titleAmendment by section 2321(b), (d)(4)(A) of applicable to items and services furnished on or after , see , set out as a note under .

Pub. L. 98–369, div. B, title III, § 2323(d)98 Stat. 1086

“The amendments made by this section [amending this section and sections 1395x, 1395cc, and 1395rr of this title and enacting provisions set out below] apply to services furnished on or after .”
, , , provided that:

Pub. L. 98–369section 2354(e)(1) of Pub. L. 98–369section 1320a–1 of this titleAmendment by section 2354(b)(5), (7) of effective , but not to be construed as changing or affecting any right, liability, status, or interpretation which existed (under the provisions of law involved) before that date, see , set out as a note under .

Effective Date of 1982 Amendment

Pub. L. 97–248, title I, § 112(c)96 Stat. 340

“The amendments made by this section [amending this section] shall apply with respect to items and services furnished on or after .”
, , , provided that:

section 117(a)(2) of Pub. L. 97–248section 117(b) of Pub. L. 97–248section 1395g of this titleAmendment by applicable to final determinations made on or after , see , set out as a note under .

section 148(d) of Pub. L. 97–248section 149 of Pub. L. 97–248section 1320c of this titleAmendment by effective with respect to contracts entered into or renewed on or after , see , set out as an Effective Date note under .

Effective Date of 1981 Amendment

Pub. L. 97–35, title XXI, § 2106(c)95 Stat. 792

section 1395q(b) of this title“The amendment made by subsection (a) [amending this section] is effective as of , and the amendment made by subsection (b)(2) [amending ], is effective as of .”
, , , provided that:

Pub. L. 97–35, title XXI, § 2133(b)95 Stat. 797

“The amendments made by subsection (a) [amending this section] first apply to the deductible for calendar year 1982 with respect to expenses incurred on or after .”
, , , provided that:

Pub. L. 97–35, title XXI, § 2134(b)95 Stat. 797

“The amendment made by subsection (a) [amending this section] shall take effect on , and shall apply to the deductible for calendar years beginning with 1982.”
, , , provided that:

Effective Date of 1980 Amendment

Pub. L. 96–611, § 294 Stat. 3567

“The amendments made by this Act [probably should be the amendments made by section 1 of this Act, which amended this section and sections 1395x, 1395y, 1395aa, and 1395cc of this title] shall take effect on, and apply to services furnished on or after, .”
, , , provided that:

section 930(h) of Pub. L. 96–499section 930(s)(1) of Pub. L. 96–499section 1395x of this titleAmendment by , effective with respect to services furnished on or after , see , set out as a note under .

Pub. L. 96–499, title IX, § 935(b)94 Stat. 2639

“The amendment made by subsection (a) [amending this section] shall apply to expenses incurred in calendar years beginning with calendar year 1982.”
, , , provided that:

Pub. L. 96–499, title IX, § 943(b)94 Stat. 2642

“The amendments made by subsection (a) [amending this section] shall apply to services furnished after the sixth calendar month beginning after the date of the enactment of this Act [].”
, , , provided that:

Effective Date of 1978 Amendment

Pub. L. 95–292section 6 of Pub. L. 95–292section 426 of this titleAmendment by effective with respect to services, supplies, and equipment furnished after the third calendar month beginning after , except that provisions for the implementation of an incentive reimbursement system for dialysis services furnished in facilities and providers to become effective with respect to a facility’s or provider’s first accounting period beginning after the last day of the twelfth month following the month of June 1978, and except that provisions for reimbursement rates for home dialysis to become effective on , see , set out as a note under .

Effective Date of 1977 Amendment

Pub. L. 95–210section 1(j) of Pub. L. 95–210section 1395k of this titleAmendment by applicable to services rendered on or after first day of third calendar month which begins after , see , set out as a note under .

Pub. L. 95–142, § 16(b)91 Stat. 1201

“The amendment made by subsection (a) [amending this section] shall apply with respect to durable medical equipment purchased or rented on or after .”
, , , provided that:

Effective Date of 1972 Amendment

Pub. L. 92–603, title II, § 204(c)86 Stat. 1377

section 1395n of this title42 U.S.C. 1395l“The amendments made by this section [amending this section and ] shall be effective with respect to calendar years after 1972 (except that, for purposes of applying clause (1) of the first sentence of section 1833(b) of the Social Security Act [(b)], such amendments shall be deemed to have taken effect on ).”
, , , provided that:

section 211(c)(4) of Pub. L. 92–603section 211(d) of Pub. L. 92–603section 1395f of this titleAmendment by applicable to services furnished with respect to admissions occurring after , see , set out as a note under .

section 226(c)(2) of Pub. L. 92–603section 226(f) of Pub. L. 92–603section 1395mm of this titleAmendment by effective with respect to services provided on or after , see , set out as an Effective Date note under .

section 233(b) of Pub. L. 92–603section 233(f) of Pub. L. 92–603section 1395f of this titlePub. L. 93–233, § 1687 Stat. 967section 1395f of this titleAmendment by applicable to services furnished by hospitals, extended care facilities, and home health agencies in accounting periods beginning after , see , set out as a note under . See, also, , , , set out as a note under .

Pub. L. 92–603section 251(d)(1) of Pub. L. 92–603section 1395x of this titleAmendment by section 251(a)(2), (3) of applicable with respect to services furnished on or after , see , set out as a note under .

Pub. L. 92–603, title II, § 299K(b)86 Stat. 1464

“The amendment made by subsection (a) [amending this section] shall apply to services furnished by home health agencies in accounting periods beginning after .”
, , , provided that:

Effective Date of 1968 Amendment

Pub. L. 90–248section 129(d) of Pub. L. 90–248section 1395d of this titleAmendment by section 129(c)(7), (8) of applicable with respect to services furnished after , see , set out as a note under .

Pub. L. 90–248, title I, § 131(c)81 Stat. 850

“The amendments made by this section [amending this section] shall apply with respect to services furnished after .”
, , , provided that:

Pub. L. 90–248, title I, § 132(c)81 Stat. 850

section 1395x of this title“The amendments made by this section [amending this section and ] shall apply only with respect to items purchased after .”
, , , provided that:

section 135(c) of Pub. L. 90–248section 135(d) of Pub. L. 90–248section 1395e of this titleAmendment by applicable with respect to payment for blood (or packed red blood cells) furnished an individual after , see , set out as a note under .

Construction of 2008 Amendment

Pub. L. 110–275, title I, § 101(a)(4)122 Stat. 2497

42 U.S.C. 1395“Nothing in the provisions of, or amendments made by, this subsection [amending this section and sections 1395x and 1395y of this title] shall be construed to provide coverage under title XVIII of the Social Security Act [ et seq.] of items and services for the treatment of a medical condition that is not otherwise covered under such title.”
, , , provided that:

Construction Regarding Limiting Increases in Cost-Sharing

Pub. L. 106–554, § 1(a)(6) [title I, § 111(b)]114 Stat. 2763

section 1(a)(6) of Pub. L. 106–55442 U.S.C. 139542 U.S.C. 1395l“Nothing in this Act [H.R. 5661, as enacted by , see Tables for classification] or the Social Security Act [this chapter] shall be construed as preventing a hospital from waiving the amount of any coinsurance for outpatient hospital services under the medicare program under title XVIII of the Social Security Act [ et seq.] that may have been increased as a result of the implementation of the prospective payment system under section 1833(t) of the Social Security Act ((t)).”
, , , 2763A–473, provided that:

Implementation of 2022 Amendment

Pub. L. 117–328, div. FF, title IV, § 4141(b)136 Stat. 5929

“Notwithstanding any other provision of law, the Secretary of Health and Human Service may implement the amendments made by subsection (a) [amending this section] by program instruction or otherwise.”
, , , provided that:

Pub. L. 117–169, title I, § 11407(c)136 Stat. 1905

“The Secretary of Health and Human Services shall implement this section [amending this section] for 2023 by program instruction or other forms of program guidance.”
, , , provided that:

Provider Outreach and Reporting on Certain Behavioral Health Integration Services

Pub. L. 117–328, div. FF, title IV, § 4128136 Stat. 5916

“(a)

Outreach .—

42 U.S.C. 1395The Secretary of Health and Human Services (in this section referred to as the ‘Secretary’) shall conduct outreach to physicians and appropriate non-physician practitioners participating under the Medicare program under title XVIII of the Social Security Act ( et seq.) with respect to behavioral health integration services described by any of HCPCS codes 99492 through 99494 or 99484 (or any successor code). Such outreach shall include a comprehensive, one-time education initiative to inform such physicians and practitioners of the inclusion of such services as a covered benefit under the Medicare program, including describing the requirements to bill for such codes and the requirements for beneficiary eligibility for such services.
“(b)

Reports to Congress.—

“(1)

Provider outreach .—

Not later than 1 year after the date of the completion of the education initiative described in subsection (a), the Secretary shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the outreach conducted under such subsection. Such report shall include a description of the methods used for such outreach.
“(2)

Utilization rates .—

42 U.S.C. 1395Not later than 18 months after the date of the completion of the education initiative described in subsection (a), and two years thereafter, the Secretary shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the number of Medicare beneficiaries (including those beneficiaries accessing services in rural and underserved areas) who, during the preceding year, were furnished services described in subsection (a) for which payment was made under title XVIII of the Social Security Act ( et seq.).”
, , , provided that:

Outreach and Reporting on Opioid Use Disorder Treatment Services Furnished by Opioid Treatment Programs

Pub. L. 117–328, div. FF, title IV, § 4129136 Stat. 5916

“(a)

Outreach.—

“(1)

Provider outreach .—

42 U.S.C. 139542 U.S.C. 1395x(jjj)The Secretary of Health and Human Services (in this section referred to as the ‘Secretary’) shall conduct outreach to physicians and appropriate non-physician practitioners participating under the Medicare program under title XVIII of the Social Security Act ( et seq.) with respect to opioid use disorder treatment services furnished by an opioid treatment program (as defined in section 1861(jjj) of the Social Security Act ()). Such outreach shall include a comprehensive, one-time education initiative to inform such physicians and practitioners of the inclusion of such services as a covered benefit under the Medicare program, including describing the requirements for billing and the requirements for beneficiary eligibility for such services.
“(2)

Beneficiary outreach .—

42 U.S.C. 1395x(jjj)The Secretary shall conduct outreach to Medicare beneficiaries with respect to opioid use disorder treatment services furnished by an opioid treatment program (as defined in section 1861(jjj) of the Social Security Act ()), including a comprehensive, one-time education initiative informing such beneficiaries about the eligibility requirements to receive such services.
“(b)

Reports to Congress.—

“(1)

Outreach .—

Not later than 1 year after the date of the completion of the education initiatives described in subsection (a), the Secretary shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the outreach conducted under such subsection. Such report shall include a description of the methods used for such outreach.
“(2)

Utilization rates .—

42 U.S.C. 1395x(jjj)42 U.S.C. 1395Not later than 18 months after the date of the completion of the education initiatives described in subsection (a), and two years thereafter, the Secretary shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the number of Medicare beneficiaries who, during the preceding year, were furnished opioid use disorder treatment services by an opioid treatment program (as defined in section 1861(jjj) of the Social Security Act ()) for which payment was made under title XVIII of such Act ( et seq.).”
, , , provided that:

Centers for Medicare & Medicaid Services Provider Outreach and Reporting on Cognitive Assessment and Care Plan Services

Pub. L. 116–260, div. CC, title I, § 116134 Stat. 2949

“(a)

Outreach .—

42 U.S.C. 1395The Secretary of Health and Human Services (in this section referred to as the ‘Secretary’) shall conduct outreach to physicians and appropriate non-physician practitioners participating under the Medicare program under title XVIII of the Social Security Act ( et seq.) with respect to Medicare payment for cognitive assessment and care plan services furnished to individuals with cognitive impairment such as Alzheimer’s disease and related dementias, identified as of , by HCPCS code 99483, or any successor to such code (in this section referred to as ‘cognitive assessment and care plan services’). Such outreach shall include a comprehensive, one-time education initiative to inform such physicians and practitioners of the addition of such services as a covered benefit under the Medicare program, including the requirements for eligibility for such services.
“(b)

Reports.—

“(1)

HHS report on provider outreach .—

Not later than one year after the date of enactment of this Act [], the Secretary of Health and Human Services shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the outreach conducted under subsection (a). Such report shall include a description of the methods used for such outreach.
“(2)

GAO report on utilization rates .—

42 U.S.C. 1395Not later than 3 years after such date of enactment, the Comptroller General of the United States shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the number of Medicare beneficiaries who were furnished cognitive assessment and care plan services for which payment was made under title XVIII of the Social Security Act ( et seq.). Such report shall include information on barriers Medicare beneficiaries face to access such services, and recommendations for such legislative and administrative action as the Comptroller General deems appropriate.”
, , , provided that:

Implementation of 2020 Amendment

Pub. L. 116–136, div. A, title III, § 3713(e)134 Stat. 424

“Notwithstanding any other provision of law, the Secretary [probably means Secretary of Health and Human Services] may implement the provisions of, and the amendments made by, this section [amending this section and sections 1395w–22 and 1395x of this title] by program instruction or otherwise.”
, , , provided that:

Claims Modifier

Pub. L. 116–127, div. F, § 6002(b)134 Stat. 203

42 U.S.C. 1395l42 U.S.C. 1395l“The Secretary of Health and Human Services shall provide for an appropriate modifier (or other identifier) to include on claims to identify, for purposes of subparagraph (DD) of section 1833(a)(1) [probably means section 1833(a)(1)(DD) of the Social Security Act, (a)(1)(DD)], as added by subsection (a), specified COVID–19 testing-related services described in paragraph (1) of section 1833(cc) of the Social Security Act [(cc)], as added by subsection (a), for which payment may be made under a specified outpatient payment provision described in paragraph (2) of such subsection.”
, , , provided that:

Pub. L. 116–127Implementation of Provisions of

Pub. L. 116–127, div. F, § 6002(c)134 Stat. 203

“Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the provisions of, including amendments made by, this section [amending this section and enacting provisions set out as a note above] through program instruction or otherwise.”
, , , provided that:

Implementation of 2019 Amendment

Pub. L. 116–94, div. N, title I, § 107(b)133 Stat. 3102

“Notwithstanding any other provision of law, the Secretary of Health and Human Service may implement the amendments made by subsection (a) [amending this section] by program instruction or otherwise.”
, , , provided that:

Implementation of 2018 Amendment

Pub. L. 115–141, div. S, title XIII, § 1301(a)(3)132 Stat. 1150

“Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendments made by paragraphs (1) and (2) [amending this section] by program instruction or otherwise.”
, , , provided that:

Improving Documentation of Services

Pub. L. 114–10, title V, § 514(b)129 Stat. 173

“(1)

In general .—

42 U.S.C. 1395kk–1(a)(3)(A)42 U.S.C. 1395x(r)(5)42 U.S.C. 1395y(a)(1)The Secretary of Health and Human Services shall, in consultation with stakeholders (including the American Chiropractic Association) and representatives of medicare administrative contractors (as defined in section 1874A(a)(3)(A) of the Social Security Act ()), develop educational and training programs to improve the ability of chiropractors to provide documentation to the Secretary of services described in section 1861(r)(5) [] in a manner that demonstrates that such services are, in accordance with section 1862(a)(1) of such Act (), reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.
“(2)

Timing .—

The Secretary shall make the educational and training programs described in paragraph (1) publicly available not later than .
“(3)

Funding .—

42 U.S.C. 1395ddd(h)The Secretary shall use funds made available under paragraph (10) of section 1893(h) of the Social Security Act (), as added by section 505, to carry out this subsection.”
, , , provided that:

Medicare Patient IVIG Access Demonstration Project

Pub. L. 112–242, title I, § 101126 Stat. 2374Pub. L. 115–63, title III, § 302131 Stat. 1172Pub. L. 116–260, div. CC, title I, § 104134 Stat. 2943

“(a)

Establishment .—

42 U.S.C. 1395jThe Secretary shall establish and implement a demonstration project under part B of title XVIII of the Social Security Act [ et seq.] to evaluate the benefits of providing payment for items and services needed for the in-home administration of intravenous immune globin for the treatment of primary immune deficiency diseases.
“(b)

Duration and Scope.—

“(1)

Duration .—

Beginning not later than one year after the date of enactment of this Act [], the Secretary shall conduct the demonstration project for a period of 3 years and, subject to the availability of funds under subsection (g), the period beginning on , and ending on .
“(A)
Pub. L. 115–63 if the date of enactment of the Disaster Tax Relief and Airport and Airway Extension Act of 2017 is on or before [ was approved ], for the period beginning on , and ending on ; and
“(B)
if the date of enactment of such Act is after , for the period beginning on the date of enactment of such Act and ending on .
“(2)

Scope .—

The Secretary shall enroll for participation in the demonstration project for the period beginning on , and ending on , not more than 4,000 Medicare beneficiaries who have been diagnosed with primary immunodeficiency disease and for the period beginning on , and ending on , not more than 6,500 Medicare beneficiaries who have been so diagnosed. A Medicare beneficiary may participate in the demonstration project on a voluntary basis and may terminate participation at any time. Subject to the preceding sentence, a Medicare beneficiary enrolled in the demonstration project on , shall be automatically enrolled during the period beginning on the date of the enactment of the Disaster Tax Relief and Airport and Airway Extension Act of 2017 and ending on , without submission of another application.
“(c)

Coverage .—

Except as otherwise provided in this section, items and services for which payment may be made under the demonstration program shall be treated and covered under part B of title XVIII of the Social Security Act in the same manner as similar items and services covered under such part.
“(d)

Payment .—

42 U.S.C. 1395fffThe Secretary shall establish a per visit payment amount for items and services needed for the in-home administration of intravenous immune globin based on the national per visit low-utilization payment amount under the prospective payment system for home health services established under section 1895 of the Social Security Act ().
“(e)

Waiver Authority .—

42 U.S.C. 1395The Secretary may waive such requirements of title XVIII of the Social Security Act [ et seq.] as may be necessary to carry out the demonstration project.
“(f)

Study and Report to Congress.—

“(1)

Interim evaluation and report .—

Not later than three years after the date of enactment of this Act, the Secretary shall submit to Congress a report that contains an interim evaluation of the impact of the demonstration project on access for Medicare beneficiaries to items and services needed for the in-home administration of intravenous immune globin.
“(2)

Updated evaluation and report .—

Not later than 2 years after the date of the enactment of [the] Consolidated Appropriations Act, 2021 [], the Secretary shall submit to Congress an updated report that contains the following:
“(A)
The total number of beneficiaries enrolled in the demonstration project during the updated report period.
“(B)
The total number of claims submitted for services during the updated report period, disaggregated by month.
“(C)
An analysis of the impact of the demonstration on beneficiary access to the in-home administration of intravenous immune globin, including the impact on beneficiary health.
“(D)
An analysis of the impact of in-home administration of intravenous immune globin on overall costs to Medicare, including the cost differential between in-home administration of intravenous immune globin and administration of intravenous immune globin in a healthcare facility.
“(E)
To the extent practicable, a survey of providers and enrolled beneficiaries that participated in the demonstration project that identifies barriers to accessing services, including reimbursement for items and services.
“(F)
Recommendations to Congress on the appropriateness of establishing a permanent bundled services payment for the in-home administration of intravenous immune globin for Medicare beneficiaries.
“(3)

Final evaluation and report .—

Not later than one year after the date of completion of the demonstration project, the Secretary shall submit to Congress a report that contains the following:
“(A)
A final evaluation of the impact of the demonstration project on access for Medicare beneficiaries to items and services needed for the in-home administration of intravenous immune globin.
“(B)
42 U.S.C. 1395k An analysis of the appropriateness of implementing a new methodology for payment for intravenous immune globulins in all care settings under part B of title XVIII of the Social Security Act ( [1395j] et seq.).
“(C)
An update to the report entitled ‘Analysis of Supply, Distribution, Demand, and Access Issues Associated with Immune Globulin Intravenous (IGIV)’, issued in February 2007 by the Office of the Assistant Secretary for Planning and Evaluation of the Department of Health and Human Services.
“(g)

Funding .—

42 U.S.C. 1395tThere shall be made available to the Secretary to carry out the demonstration project not more than $45,000,000 from the Federal Supplementary Medical Insurance Trust Fund under section 1841 of the Social Security Act ().
“(h)

Definitions .—

In this section:
“(1)

Demonstration project .—

The term ‘demonstration project’ means the demonstration project conducted under this section.
“(2)

Medicare beneficiary .—

The term ‘Medicare beneficiary’ means an individual who is enrolled for benefits under part B of title XVIII of the Social Security Act.
“(3)

Secretary .—

The term ‘Secretary’ means the Secretary of Health and Human Services.
“(4)

Updated report period .—

The term ‘updated report period’ means the period beginning on , and ending on .”
, , , as amended by , , ; , , , provided that:

Pub. L. 116–260, § 104(b)section 101 of Pub. L. 112–242[, (c), which directed amendment of section 101 without specifying the Act to be amended, was executed to , set out above, to reflect the probable intent of Congress.]

Implementation of 2013 Amendment

Pub. L. 112–240, title VI, § 603(d)126 Stat. 2347

“Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the provisions of, and the amendments made by, this section [amending this section] by program instruction or otherwise.”
, , , provided that:

Implementation of 2012 Amendment

Pub. L. 112–96, title III, § 3005(d)126 Stat. 189

section 1395u of this title42 U.S.C. 1395l“The Secretary of Health and Human Services shall implement such claims processing edits and issue such guidance as may be necessary to implement the amendments made by this section [amending this section and ] in a timely manner. Notwithstanding any other provision of law, the Secretary may implement the amendments made by this section by program instruction. Of the amount of funds made available to the Secretary for fiscal year 2012 for program management for the Centers for Medicare & Medicaid Services, not to exceed $9,375,000 shall be available for such fiscal year and the first 3 months of fiscal year 2013 to carry out section 1833(g)(5)(C) of the Social Security Act [(g)(5)(C)] (relating to manual medical review), as added by subsection (a).”
, , , provided that:

Collection of Additional Data

Pub. L. 112–96, title III, § 3005(g)126 Stat. 189

“(1)

Strategy .—

42 U.S.C. 1395lThe Secretary of Health and Human Services shall implement, beginning on , a claims-based data collection strategy that is designed to assist in reforming the Medicare payment system for outpatient therapy services subject to the limitations of section 1833(g) of the Social Security Act ((g)). Such strategy shall be designed to provide for the collection of data on patient function during the course of therapy services in order to better understand patient condition and outcomes.
“(2)

Consultation .—

In proposing and implementing such strategy, the Secretary shall consult with relevant stakeholders.”
, , , provided that:

Treatment of Certain Complex Diagnostic Laboratory Tests

Pub. L. 111–148, title III, § 3113124 Stat. 422

“(a)

Demonstration Project.—

“(1)

In general .—

42 U.S.C. 1395jThe Secretary of Health and Human Services (in this section referred to as the ‘Secretary’) shall conduct a demonstration project under part B [of] title XVIII of the Social Security Act [ et seq.] under which separate payments are made under such part for complex diagnostic laboratory tests provided to individuals under such part. Under the demonstration project, the Secretary shall establish appropriate payment rates for such tests.
“(2)

Covered complex diagnostic laboratory test defined .—

In this section, the term ‘complex diagnostic laboratory test’ means a diagnostic laboratory test—
“(A)
that is an analysis of gene protein expression, topographic genotyping, or a cancer chemotherapy sensitivity assay;
“(B)
that is determined by the Secretary to be a laboratory test for which there is not an alternative test having equivalent performance characteristics;
“(C)
which is billed using a Health Care Procedure Coding System (HCPCS) code other than a not otherwise classified code under such Coding System;
“(D)
42 U.S.C. 1395 which is approved or cleared by the Food and Drug Administration or is covered under title XVIII of the Social Security Act [ et seq.]; and
“(E)
42 U.S.C. 1395x(s)(3) is described in section 1861(s)(3) of the Social Security Act ().
“(3)

Separate payment defined .—

42 U.S.C. 1395y(a)(14)42 U.S.C. 1395cc(a)(1)(H)(i)In this section, the term ‘separate payment’ means direct payment to a laboratory (including a hospital-based or independent laboratory) that performs a complex diagnostic laboratory test with respect to a specimen collected from an individual during a period in which the individual is a patient of a hospital if the test is performed after such period of hospitalization and if separate payment would not otherwise be made under title XVIII of the Social Security Act by reason of sections 1862(a)(14) and 1866(a)(1)(H)(i) of the such [sic] Act (; ).
“(b)

Duration .—

Subject to subsection (c)(2), the Secretary shall conduct the demonstration project under this section for the 2-year period beginning on .
“(c)

Payments and Limitation .—

Payments under the demonstration project under this section shall—
“(1)
42 U.S.C. 1395t be made from the Federal Supplemental [probably should be “Supplementary”] Medical Insurance Trust Fund under section 1841 of the Social Security Act (); and
“(2)
may not exceed $100,000,000.
“(d)

Report .—

Not later than 2 years after the completion of the demonstration project under this section, the Secretary shall submit to Congress a report on the project. Such report shall include—
“(1)
42 U.S.C. 1395 an assessment of the impact of the demonstration project on access to care, quality of care, health outcomes, and expenditures under title XVIII of the Social Security Act [ et seq.] (including any savings under such title); and
“(2)
such recommendations as the Secretary determines appropriate.
“(e)

Implementation Funding .—

42 U.S.C. 1395tFor purposes of administering this section (including preparing and submitting the report under subsection (d)), the Secretary shall provide for the transfer, from the Federal Supplemental [probably should be “Supplementary”] Medical Insurance Trust Fund under section 1841 of the Social Security Act (), to the Centers for Medicare & Medicaid Services Program Management Account, of $5,000,000. Amounts transferred under the preceding sentence shall remain available until expended.”
, , , provided that:

Treatment of Certified Registered Nurse Anesthetists

Pub. L. 110–275, title I, § 139(b)122 Stat. 2541

42 U.S.C. 1395“With respect to items and services furnished on or after , the Secretary of Health and Human Services shall make appropriate adjustments to payments under the Medicare program under title XVIII of the Social Security Act [ et seq.] for teaching certified registered nurse anesthetists to implement a policy with respect to teaching certified registered nurse anesthetists that—
“(1)
42 U.S.C. 1395w–4(a)(6) is consistent with the adjustments made by the special rule for teaching anesthesiologists under section 1848(a)(6) of the Social Security Act [], as added by subsection (a); and
“(2)
maintains the existing payment differences between teaching anesthesiologists and teaching certified registered nurse anesthetists.”
, , , provided that:

Implementation of 2006 Amendment

Pub. L. 109–432, div. B, title I, § 107(b)(2)120 Stat. 2983

“The Secretary of Health and Human Services may implement the amendment made by paragraph (1) [amending this section] by program instruction or otherwise.”
, , , provided that:

Pub. L. 109–171, title V, § 5107(a)(2)120 Stat. 42

section 110(c) of Public Law 108–173section 1395w–101 of this title42 U.S.C. 1395ffoo42 U.S.C. 1395l“The Secretary of Health and Human Services shall waive such provisions of law and regulation (including those described in [set out as a note under ]) as are necessary to implement the amendments made by paragraph (1) [amending this section] on a timely basis and, notwithstanding any other provision of law, may implement such amendments by program instruction or otherwise. There shall be no administrative or judicial review under section 1869 or section 1878 of the Social Security Act ( and 1395), or otherwise of the process (including the establishment of the process) under section 1833(g)(5) of such Act [(g)(5)], as added by paragraph (1).”
, , , provided that:

Implementation of Clinically Appropriate Code Edits In Order To Identify and Eliminate Improper Payments for Therapy Services

Pub. L. 109–171, title V, § 5107(b)120 Stat. 43

42 U.S.C. 1395j“By not later than , the Secretary of Health and Human Services shall implement clinically appropriate code edits with respect to payments under part B of title XVIII of the Social Security Act [ et seq.] for physical therapy services, occupational therapy services, and speech-language pathology services in order to identify and eliminate improper payments for such services, including edits of clinically illogical combinations of procedure codes and other edits to control inappropriate billings.”
, , , provided that:

Application of 2003 Amendment to Physician Specialties

section 303 of Pub. L. 108–173section 303(j) of Pub. L. 108–173section 1395u of this titleAmendment by , insofar as applicable to payments for drugs or biologicals and drug administration services furnished by physicians, is applicable only to physicians in the specialties of hematology, hematology/oncology, and medical oncology under this subchapter, see , set out as a note under .

section 303(j) of Pub. L. 108–173section 303 of Pub. L. 108–173section 304 of Pub. L. 108–173section 1395u of this titleNotwithstanding (see note above), amendment by also applicable to payments for drugs or biologicals and drug administration services furnished by physicians in specialties other than the specialties of hematology, hematology/oncology, and medical oncology, see , set out as a note under .

GAO Study of Medicare Payment for Inhalation Therapy

Pub. L. 108–173, title III, § 305(b)117 Stat. 2255, , , required the Comptroller General of the United States to conduct a study to examine the adequacy of reimbursements for inhalation therapy under the medicare program, and to submit to Congress a report on this study not later than 1 year after .

Treatment of Certain Clinical Diagnostic Laboratory Tests Furnished to Hospital Outpatients in Certain Rural Areas

Pub. L. 108–173, title IV, § 416117 Stat. 2282Pub. L. 109–432, div. B, title I, § 105120 Stat. 2981Pub. L. 110–173, title I, § 107121 Stat. 2496Pub. L. 111–148, title III, § 3122124 Stat. 423Pub. L. 111–309, title I, § 109124 Stat. 3288

“(a)

In General .—

42 U.S.C. 1395l42 U.S.C. 1395m(d)(1)42 U.S.C. 1395jl42 U.S.C. 1395mlNotwithstanding subsections (a), (b), and (h) of section 1833 of the Social Security Act () and section 1834(d)(1) of such Act (), in the case of a clinical diagnostic laboratory test covered under part B of title XVIII of such Act [ et seq.] that is furnished during a cost reporting period described in subsection (b) by a hospital with fewer than 50 beds that is located in a qualified rural area (identified under paragraph (12)(B)(iii) of section 1834() of the Social Security Act (()), as added by section 414(c)) as part of outpatient services of the hospital, the amount of payment for such test shall be 100 percent of the reasonable costs of the hospital in furnishing such test.
“(b)

Application .—

A cost reporting period described in this subsection is a cost reporting period beginning during the period beginning on , and ending on or during the 2-year period beginning on .
“(c)

Provision as Part of Outpatient Hospital Services .—

42 U.S.C. 1395m(g)(4)For purposes of subsection (a), in determining whether clinical diagnostic laboratory services are furnished as part of outpatient services of a hospital, the Secretary [of Health and Human Services] shall apply the same rules that are used to determine whether clinical diagnostic laboratory services are furnished as an outpatient critical access hospital service under section 1834(g)(4) of the Social Security Act ().”
, , , as amended by , , ; , , ; , , ; , , , provided that:

Pub. L. 109–432, div. B, title I, § 105120 Stat. 2981section 416(b) of Pub. L. 108–173section 416 of Pub. L. 108–173[, , , provided that the amendment made by that section to , set out above, is effective as if included in the enactment of .]

GAO Report on Payments for Brachytherapy Devices

Pub. L. 108–173, title VI, § 621(b)(3)117 Stat. 2311

42 U.S.C. 1395l“The Comptroller General of the United States shall conduct a study to determine appropriate payment amounts under section 1833(t)(16)(C) of the Social Security Act [(t)(16)(C)], as added by paragraph (1), for devices of brachytherapy. Not later than , the Comptroller General shall submit to Congress and the Secretary [of Health and Human Services] a report on the study conducted under this paragraph, and shall include specific recommendations for appropriate payments for such devices.”
, , , provided that:

Moratorium on Physical Therapy Services Caps in 2003

Pub. L. 108–173, title VI, § 624(a)(2)117 Stat. 2317

42 U.S.C. 1395l“For the period beginning on the date of the enactment of this Act [] and ending of [sic] , the Secretary [of Health and Human Services] shall not apply the provisions of paragraphs (1), (2), and (3) of section 1833(g) [(g)] to expenses incurred with respect to services described in such paragraphs during such period. Nothing in the preceding sentence shall be construed as affecting the application of such paragraphs by the Secretary before the date of the enactment of this Act.”
, , , provided that:

Prompt Submission of Overdue Reports on Payment and Utilization of Outpatient Therapy Services

Pub. L. 108–173, title VI, § 624(b)117 Stat. 2317

Public Law 105–33111 Stat. 457113 Stat. 1501section 1000(a)(6) of Public Law 106–113“Not later than , the Secretary [of Health and Human Services] shall submit to Congress the reports required under section 4541(d)(2) of the Balanced Budget Act of 1997 (; ) [set out as a note under this section] (relating to alternatives to a single annual dollar cap on outpatient therapy) and under section 221(d) of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (Appendix F, A–352), as enacted into law by [set out as a note under this section] (relating to utilization patterns for outpatient therapy).”
, , , provided that:

GAO Study of Ambulatory Surgical Center Payments

Pub. L. 108–173, title VI, § 626(d)117 Stat. 2319

“(1)

Study.—

“(A)

In general .—

42 U.S.C. 1395lThe Comptroller General of the United States shall conduct a study that compares the relative costs of procedures furnished in ambulatory surgical centers to the relative costs of procedures furnished in hospital outpatient departments under section 1833(t) of the Social Security Act ((t)). The study shall also examine how accurately ambulatory payment categories reflect procedures furnished in ambulatory surgical centers.
“(B)

Consideration of asc data .—

In conducting the study under paragraph (1), the Comptroller General shall consider data submitted by ambulatory surgical centers regarding the matters described in clauses (i) through (iii) of paragraph (2)(B).
“(2)

Report and recommendations.—

“(A)

Report .—

Not later than , the Comptroller General shall submit to Congress a report on the study conducted under paragraph (1).
“(B)

Recommendations .—

The report submitted under subparagraph (A) shall include recommendations on the following matters:
“(i)
The appropriateness of using the groups of covered services and relative weights established under the outpatient prospective payment system as the basis of payment for ambulatory surgical centers.
“(ii)
If the relative weights under such hospital outpatient prospective payment system are appropriate for such purpose—
“(I)
whether the payment rates for ambulatory surgical centers should be based on a uniform percentage of the payment rates or weights under such outpatient system; or
“(II)
whether the payment rates for ambulatory surgical centers should vary, or the weights should be revised, based on specific procedures or types of services (such as ophthalmology and pain management services).
“(iii)
Whether a geographic adjustment should be used for payment of services furnished in ambulatory surgical centers, and if so, the labor and nonlabor shares of such payment.”
, , , provided that:

Demonstration Project for Coverage of Certain Prescription Drugs and Biologicals

Pub. L. 108–173, title VI, § 641117 Stat. 2321

“(a)

Demonstration Project .—

42 U.S.C. 1395j42 U.S.C. 1395x(s)(2)(A)42 U.S.C. 1395w–102(b)The Secretary [of Health and Human Services] shall conduct a demonstration project under part B of title XVIII of the Social Security Act [ et seq.] under which payment is made for drugs or biologicals that are prescribed as replacements for drugs and biologicals described in section 1861(s)(2)(A) or 1861(s)(2)(Q) of such Act (, 1395x(s)(2)(Q)), or both, for which payment is made under such part. Such project shall provide for cost-sharing applicable with respect to such drugs or biologicals in the same manner as cost-sharing applies with respect to part D [part D of this subchapter] drugs under standard prescription drug coverage (as defined in section 1860D–2(b) of the Social Security Act [], as added by section 101(a)).
“(b)

Demonstration Project Sites .—

The project established under this section shall be conducted in sites selected by the Secretary.
“(c)

Duration .—

The Secretary shall conduct the demonstration project for the 2-year period beginning on the date that is 90 days after the date of the enactment of this Act [], but in no case may the project extend beyond .
“(d)

Limitation .—

Under the demonstration project over the duration of the project, the Secretary may not provide—
“(1)
coverage for more than 50,000 patients; and
“(2)
more than $500,000,000 in funding.
“(e)

Report .—

Not later than , the Secretary shall submit to Congress a report on the project. The report shall include an evaluation of patient access to care and patient outcomes under the project, as well as an analysis of the cost effectiveness of the project, including an evaluation of the costs savings (if any) to the medicare program attributable to reduced physicians’ services and hospital outpatient departments services for administration of the biological.”
, , , provided that:

Payment for Pancreatic Islet Cell Investigational Transplants for Medicare Beneficiaries in Clinical Trials

Pub. L. 108–173, title VII, § 733117 Stat. 2352

“(a)

Clinical Trial.—

“(1)

In general .—

The Secretary [of Health and Human Services], acting through the National Institute of Diabetes and Digestive and Kidney Disorders, shall conduct a clinical investigation of pancreatic islet cell transplantation which includes medicare beneficiaries.
“(2)

Authorization of appropriations .—

There are authorized to be appropriated to the Secretary such sums as may be necessary to conduct the clinical investigation under paragraph (1).
“(b)

Medicare Payment .—

42 U.S.C. 139542 U.S.C. 1395cNot earlier than , the Secretary shall pay for the routine costs as well as transplantation and appropriate related items and services (as described in subsection (c)) in the case of medicare beneficiaries who are participating in a clinical trial described in subsection (a) as if such transplantation were covered under title XVIII of such Act [ et seq.] and as would be paid under part A or part B of such title [ et seq., 1395j et seq.] for such beneficiary.
“(c)

Scope of Payment .—

For purposes of subsection (b):
“(1)
The term ‘routine costs’ means reasonable and necessary routine patient care costs (as defined in the Centers for Medicare & Medicaid Services Coverage Issues Manual, section 30–1), including immunosuppressive drugs and other followup care.
“(2)
The term ‘transplantation and appropriate related items and services’ means items and services related to the acquisition and delivery of the pancreatic islet cell transplantation, notwithstanding any national noncoverage determination contained in the Centers for Medicare & Medicaid Services Coverage Issues Manual.
“(3)
42 U.S.C. 1395c42 U.S.C. 1395j The term ‘medicare beneficiary’ means an individual who is entitled to benefits under part A of title XVIII of the Social Security Act [ et seq.], or enrolled under part B of such title [ et seq.], or both.
“(d)

Construction .—

The provisions of this section shall not be construed—
“(1)
42 U.S.C. 1395 to permit payment for partial pancreatic tissue or islet cell transplantation under title XVIII of the Social Security Act [ et seq.] other than payment as described in subsection (b); or
“(2)
as authorizing or requiring coverage or payment conveying—
“(A)
42 U.S.C. 1395c benefits under part A of such title [ et seq.] to a beneficiary not entitled to such part A; or
“(B)
42 U.S.C. 1395j benefits under part B of such title [ et seq.] to a beneficiary not enrolled in such part B.”
, , , provided that:

GAO Study of Reduction in Medigap Premium Levels Resulting From Reductions in Coinsurance

Pub. L. 106–554, § 1(a)(6) [title I, § 111(c)]114 Stat. 2763Pub. L. 114–301, § 2(b)130 Stat. 1514, , , 2763A–473, related to GAO study of reduction in medigap premium levels resulting from reductions in coinsurance and subsequent report to Congress, prior to repeal by , , .

MedPAC Study on Low-Volume, Isolated Rural Health Care Providers

Pub. L. 106–554, § 1(a)(6) [title II, § 225]114 Stat. 2763

“(a)

Study .—

42 U.S.C. 1395The Medicare Payment Advisory Commission shall conduct a study on the effect of low patient and procedure volume on the financial status of low-volume, isolated rural health care providers participating in the medicare program under title XVIII of the Social Security Act [ et seq.].
“(b)

Report .—

Not later than 18 months after the date of the enactment of this Act [], the Commission shall submit to Congress a report on the study conducted under subsection (a) indicating—
“(1)
whether low-volume, isolated rural health care providers are having, or may have, significantly decreased medicare margins or other financial difficulties resulting from any of the payment methodologies described in subsection (c);
“(2)
whether the status as a low-volume, isolated rural health care provider should be designated under the medicare program and any criteria that should be used to qualify for such a status; and
“(3)
any changes in the payment methodologies described in subsection (c) that are necessary to provide appropriate reimbursement under the medicare program to low-volume, isolated rural health care providers (as designated pursuant to paragraph (2)).
“(c)

Payment Methodologies Described .—

The payment methodologies described in this subsection are the following:
“(1)
42 U.S.C. 1395l The prospective payment system for hospital outpatient department services under section 1833(t) of the Social Security Act ((t)).
“(2)
l42 U.S.C. 1395ml The fee schedule for ambulance services under section 1834() of such Act (()).
“(3)
42 U.S.C. 1395ww The prospective payment system for inpatient hospital services under section 1886 of such Act ().
“(4)
42 U.S.C. 1395yy(e) The prospective payment system for routine service costs of skilled nursing facilities under section 1888(e) of such Act ().
“(5)
42 U.S.C. 1395fff The prospective payment system for home health services under section 1895 of such Act ().”
, , , 2763A–490, provided that:

Special Rule for Payment for 2001

Pub. L. 106–554, § 1(a)(6) [title IV, § 401(c)]114 Stat. 2763

42 U.S.C. 1395l“Notwithstanding the amendment made by subsection (a) [amending this section], for purposes of making payments under section 1833(t) of the Social Security Act ((t)) for covered OPD services furnished during 2001, the medicare OPD fee schedule amount under such section—
“(1)
for services furnished on or after , and before , shall be the medicare OPD fee schedule amount for 2001 as determined under the provisions of law in effect on the day before the date of the enactment of this Act []; and
“(2)
for services furnished on or after , and before , shall be the fee schedule amount (as determined taking into account the amendment made by subsection (a)), increased by a transitional percentage allowance equal to 0.32 percent (to account for the timing of implementation of the full market basket update).”
, , , 2763A–503, provided that:

Transition Provisions Applicable to Subsection (t)(6)(B)

Pub. L. 106–554, § 1(a)(6) [title IV, § 402(d)]114 Stat. 2763

“(1)

In general .—

42 U.S.C. 1395lIn the case of a medical device provided as part of a service (or group of services) furnished during the period before initial categories are implemented under subparagraph (B)(i) of section 1833(t)(6) of the Social Security Act [(t)(6)(B)(i)] (as amended by subsection (a)), payment shall be made for such device under such section in accordance with the provisions in effect before the date of the enactment of this Act []. In addition, beginning on the date that is 30 days after the date of the enactment of this Act, payment shall be made for such a device that is not included in a program memorandum described in such subparagraph if the Secretary of Health and Human Services determines that the device (including a device that would have been included in such program memoranda but for the requirement of subparagraph (A)(iv)(I) of that section) is likely to be described by such an initial category.
“(2)

Application of current process .—

42 U.S.C. 1395lNotwithstanding any other provision of law, the Secretary shall continue to accept applications with respect to medical devices under the process established pursuant to paragraph (6) of section 1833(t) of the Social Security Act [(t)(6)] (as in effect on the day before the date of the enactment of this Act []) through , and any device—
“(A)
with respect to which an application was submitted (pursuant to such process) on or before such date; and
“(B)
that meets the requirements of clause (ii) or (iv) of subparagraph (A) of such paragraph (as determined pursuant to such process),
shall be treated as a device with respect to which an initial category is required to be established under subparagraph (B)(i) of such paragraph (as amended by subsection (a)(2)).”
, , , 2763A–506, provided that:

Study on Standards for Supervision of Physical Therapist Assistants

Pub. L. 106–554, § 1(a)(6) [title IV, § 421(c)]114 Stat. 2763, , , 2763A–516, required the Secretary of Health and Human Services to conduct a study of the implications of eliminating the “in the room” supervision requirement for medicare payment for services of physical therapy assistants who are supervised by physical therapists and of such requirement on the cap imposed under subsec. (g) of this section on physical therapy services, and to submit to Congress a report on the study no later than 18 months after .

Delay in Implementation of Prospective Payment System for Ambulatory Surgical Centers

Pub. L. 106–554, § 1(a)(6) [title IV, § 424(a)]114 Stat. 2763

42 U.S.C. 1395l“The Secretary of Health and Human Services may not implement a revised prospective payment system for services of ambulatory surgical facilities under section 1833(i) of the Social Security Act ((i)) before .”
, , , 2763A–518, provided that:

MedPAC Study and Report on Medicare Reimbursement for Services Provided by Certain Providers

Pub. L. 106–554, § 1(a)(6) [title IV, § 434]114 Stat. 2763

“(a)

Study .—

42 U.S.C. 1395The Medicare Payment Advisory Commission shall conduct a study on the appropriateness of the current payment rates under the medicare program under title XVIII of the Social Security Act [ et seq.] for services provided by a—
“(1)
42 U.S.C. 1395x certified nurse-midwife (as defined in subsection (gg)(2) of section 1861 of such Act ());
“(2)
physician assistant (as defined in subsection (aa)(5)(A) of such section);
“(3)
nurse practitioner (as defined in such subsection); and
“(4)
clinical nurse specialist (as defined in subsection (aa)(5)(B) of such section).
The study shall separately examine the appropriateness of such payment rates for orthopedic physician assistants, taking into consideration the requirements for accreditation, training, and education.
“(b)

Report .—

Not later than 18 months after the date of the enactment of this Act [], the Commission shall submit to Congress a report on the study conducted under subsection (a), together with any recommendations for legislation that the Commission determines to be appropriate as a result of such study.”
, , , 2763A–526, provided that:

MedPAC Study on Access to Outpatient Pain Management Services

Pub. L. 106–554, § 1(a)(6) [title IV, § 438]114 Stat. 2763

“(a)

Study .—

42 U.S.C. 1395The Medicare Payment Advisory Commission shall conduct a study on the barriers to coverage and payment for outpatient interventional pain medicine procedures under the medicare program under title XVIII of the Social Security Act [ et seq.]. Such study shall examine—
“(1)
the specific barriers imposed under the medicare program on the provision of pain management procedures in hospital outpatient departments, ambulatory surgery centers, and physicians’ offices; and
“(2)
the consistency of medicare payment policies for pain management procedures in those different settings.
“(b)

Report .—

Not later than 1 year after the date of the enactment of this Act [], the Commission shall submit to Congress a report on the study.”
, , , 2763A–528, provided that:

Establishment of Coding and Payment Procedures for New Clinical Diagnostic Laboratory Tests and Other Items on a Fee Schedule

Pub. L. 106–554, § 1(a)(6) [title V, § 531(b)]114 Stat. 2763

42 U.S.C. 1395j“Not later than 1 year after the date of the enactment of this Act [], the Secretary of Health and Human Services shall establish procedures for coding and payment determinations for the categories of new clinical diagnostic laboratory tests and new durable medical equipment under part B of title XVIII of the Social Security Act [ et seq.] that permit public consultation in a manner consistent with the procedures established for implementing coding modifications for ICD–9–CM.”
, , , 2763A–547, provided that:

Report on Procedures Used for Advanced, Improved Technologies

Pub. L. 106–554, § 1(a)(6) [title V, § 531(c)]114 Stat. 2763

42 U.S.C. 1395j“Not later than 1 year after the date of the enactment of this Act [], the Secretary of Health and Human Services shall submit to Congress a report that identifies the specific procedures used by the Secretary under part B of title XVIII of the Social Security Act [ et seq.] to adjust payments for clinical diagnostic laboratory tests and durable medical equipment which are classified to existing codes where, because of an advance in technology with respect to the test or equipment, there has been a significant increase or decrease in the resources used in the test or in the manufacture of the equipment, and there has been a significant improvement in the performance of the test or equipment. The report shall include such recommendations for changes in law as may be necessary to assure fair and appropriate payment levels under such part for such improved tests and equipment as reflects increased costs necessary to produce improved results.”
, , , 2763A–547, provided that:

Congressional Intention Regarding Base Amounts in Applying HOPD PPS

Pub. L. 106–113, div. B, § 1000(a)(6)l113 Stat. 1536

42 U.S.C. 1395lPub. L. 105–33“With respect to determining the amount of copayments described in paragraph (3)(A)(ii) of section 1833(t) of the Social Security Act [(t)(3)(A)(ii)], as added by section 4523(a) of BBA [the Balanced Budget Act of 1997, ], Congress finds that such amount should be determined without regard to such section, in a budget neutral manner with respect to aggregate payments to hospitals, and that the Secretary of Health and Human Services has the authority to determine such amount without regard to such section.”
[title II, § 201()], , , 1501A–341, provided that:

Study and Report to Congress Regarding Special Treatment of Rural and Cancer Hospitals in Prospective Payment System for Hospital Outpatient Department Services

Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 203]113 Stat. 1536

“(a)

Study.—

“(1)

In general .—

42 U.S.C. 1395lThe Medicare Payment Advisory Commission (referred to in this section as ‘MedPAC’) shall conduct a study to determine the appropriateness (and the appropriate method) of providing payments to hospitals described in paragraph (2) for covered OPD services (as defined in paragraph (1)(B) of section 1833(t) of the Social Security Act ((t))) based on the prospective payment system established by the Secretary in accordance with such section.
“(2)

Hospitals described .—

The hospitals described in this paragraph are the following:
“(A)
42 U.S.C. 1395ww(d)(5)(G)(iv) A medicare-dependent, small rural hospital (as defined in section 1886(d)(5)(G)(iv) of the Social Security Act ()).
“(B)
42 U.S.C. 1395ww(d)(5)(D)(iii) A sole community hospital (as defined in section 1886(d)(5)(D)(iii) of such Act ()).
“(C)
42 U.S.C. 1395x(aa)(2) Rural health clinics (as defined in section 1861(aa)(2) of such Act ().
“(D)
42 U.S.C. 1395ww(d)(5)(C) Rural referral centers (as so classified under section 1886(d)(5)(C) of such Act ().
“(E)
Any other rural hospital with not more than 100 beds.
“(F)
Any other rural hospital that the Secretary determines appropriate.
“(G)
42 U.S.C. 1395ww(d)(1)(B)(v) A hospital described in section 1886(d)(1)(B)(v) of such Act ().
“(b)

Report .—

Not later than 2 years after the date of the enactment of this Act [], MedPAC shall submit a report to the Secretary of Health and Human Services and Congress on the study conducted under subsection (a), together with any recommendations for legislation that MedPAC determines to be appropriate as a result of such study.
“(c)

Comments .—

Not later than 60 days after the date on which MedPAC submits the report under subsection (b) to the Secretary of Health and Human Services, the Secretary shall submit comments on such report to Congress.”
, , , 1501A–344, provided that:

GAO Study on Resources Required To Provide Safe and Effective Outpatient Cancer Therapy

Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 213]113 Stat. 1536

“(a)

Study .—

The Comptroller General of the United States shall conduct a nationwide study to determine the physician and non-physician clinical resources necessary to provide safe outpatient cancer therapy services and the appropriate payment rates for such services under the medicare program. In making such determination, the Comptroller General shall—
“(1)
determine the adequacy of practice expense relative value units associated with the utilization of those clinical resources;
“(2)
determine the adequacy of work units in the practice expense formula; and
“(3)
assess various standards to assure the provision of safe outpatient cancer therapy services.
“(b)

Report to Congress .—

42 U.S.C. 1395jThe Comptroller General shall submit to Congress a report on the study conducted under subsection (a). The report shall include recommendations regarding practice expense adjustments to the payment methodology under part B of title XVIII of the Social Security Act [ et seq.], including the development and inclusion of adequate work units to assure the adequacy of payment amounts for safe outpatient cancer therapy services. The study shall also include an estimate of the cost of implementing such recommendations.”
, , , 1501A–350, provided that:

Focused Medical Reviews of Claims During Moratorium Period

Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 221(a)(2)]113 Stat. 1536Pub. L. 106–554, § 1(a)(6) [title IV, § 421(b)]114 Stat. 2763

42 U.S.C. 1395l“During years in which paragraph (4) of section 1833(g) of the Social Security Act ((g)) applies, the Secretary of Health and Human Services shall conduct focused medical reviews of claims for reimbursement for services described in paragraph (1) or (3) of such section, with an emphasis on such claims for services that are provided to residents of skilled nursing facilities.”
, , , 1501A–351, as amended by , , , 2763A–516, provided that:

Study and Report on Utilization

Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 221(d)]113 Stat. 1536

“(1)

Study.—

“(A)

In general .—

The Secretary of Health and Human Services shall conduct a study which compares—
“(i)
42 U.S.C. 139542 U.S.C. 1395 utilization patterns (including nationwide patterns, and patterns by region, types of settings, and diagnosis or condition) of outpatient physical therapy services, outpatient occupational therapy services, and speech-language pathology services that are covered under the medicare program under title XVIII of the Social Security Act () [ et seq.] and provided on or after ; with
“(ii)
such patterns for such services that were provided in 1998 and 1999.
“(B)

Review of claims .—

In conducting the study under this subsection the Secretary of Health and Human Services shall review a statistically significant number of claims for reimbursement for the services described in subparagraph (A).
“(2)

Report .—

Not later than , the Secretary of Health and Human Services shall submit a report to Congress on the study conducted under paragraph (1), together with any recommendations for legislation that the Secretary determines to be appropriate as a result of such study.”
, , , 1501A–352, provided that:

Phase-in of PPS for Ambulatory Surgical Centers

Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 226]113 Stat. 1536Pub. L. 106–554, § 1(a)(6) [title IV, § 424(b), (c)]114 Stat. 2763

42 U.S.C. 1395l“If the Secretary of Health and Human Services implements a revised prospective payment system for services of ambulatory surgical facilities under section 1833(i) of the Social Security Act ((i)), prior to incorporating data from the 1999 Medicare cost survey or a subsequent cost survey, such system shall be implemented in a manner so that—
“(1)
in the first year of its implementation, only a proportion (specified by the Secretary and not to exceed one-fourth) of the payment for such services shall be made in accordance with such system and the remainder shall be made in accordance with current regulations; and
“(2)
in each of the following 2 years a proportion (specified by the Secretary and not to exceed one-half and three-fourths, respectively) of the payment for such services shall be made under such system and the remainder shall be made in accordance with current regulations.
By not later than , the Secretary shall incorporate data from a 1999 medicare cost survey or a subsequent cost survey for purposes of implementing or revising such system.”
, , , 1501A–354, as amended by , , , 2763A–518, 2763A–519, provided that:

MedPAC Study on Postsurgical Recovery Care Center Services

Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 229(a)]113 Stat. 1536

“(1)

In general .—

42 U.S.C. 1395The Medicare Payment Advisory Commission shall conduct a study on the cost-effectiveness and efficacy of covering under the medicare program under title XVIII of the Social Security Act [ et seq.] services of a post-surgical recovery care center (that provides an intermediate level of recovery care following surgery). In conducting such study, the Commission shall consider data on these centers gathered in demonstration projects.
“(2)

Report .—

Not later than 1 year after the date of the enactment of this Act [Nov. 29,1999], the Commission shall submit to Congress a report on such study and shall include in the report recommendations on the feasibility, costs, and savings of covering such services under the medicare program.”
, , , 1501A–356, provided that:

Medicare Reimbursement for Telehealth Services

Pub. L. 105–33, title IV, § 4206111 Stat. 377Pub. L. 106–554, § 1(a)(6) [title II, § 223(a)]114 Stat. 2763

“(a)

In General .—

42 U.S.C. 1395j42 U.S.C. 1395x(r)42 U.S.C. 1395u(b)(18)(C)42 U.S.C. 1395ww(d)(2)(D)42 U.S.C. 254e(a)(1)(A)For services furnished on and after , and before , the Secretary of Health and Human Services shall make payments from the Federal Supplementary Medical Insurance Trust Fund under part B of title XVIII of the Social Security Act ( et seq.) in accordance with the methodology described in subsection (b) for professional consultation via telecommunications systems with a physician (as defined in section 1861(r) of such Act () or a practitioner (described in section 1842(b)(18)(C) of such Act () furnishing a service for which payment may be made under such part to a beneficiary under the medicare program residing in a county in a rural area (as defined in section 1886(d)(2)(D) of such Act ()) that is designated as a health professional shortage area under section 332(a)(1)(A) of the Public Health Service Act (), notwithstanding that the individual physician or practitioner providing the professional consultation is not at the same location as the physician or practitioner furnishing the service to that beneficiary.
“(b)

Methodology for Determining Amount of Payments .—

Public Law 104–191110 Stat. 1988Taking into account the findings of the report required under section 192 of the Health Insurance Portability and Accountability Act of 1996 (; ), the findings of the report required under paragraph (c), and any other findings related to the clinical efficacy and cost-effectiveness of telehealth applications, the Secretary shall establish a methodology for determining the amount of payments made under subsection (a) within the following parameters:
“(1)
The payment shall [be] shared between the referring physician or practitioner and the consulting physician or practitioner. The amount of such payment shall not be greater than the current fee schedule of the consulting physician or practitioner for the health care services provided.
“(2)
The payment shall not include any reimbursement for any telephone line charges or any facility fees, and a beneficiary may not be billed for any such charges or fees.
“(3)
42 U.S.C. 1395l The payment shall be made subject to the coinsurance and deductible requirements under subsections (a)(1) and (b) of section 1833 of the Social Security Act ().
“(4)
42 U.S.C. 1395w–4(a)(3)42 U.S.C. 1395w–4(g)42 U.S.C. 1395u(b)(18)42 U.S.C. 1395w–4(d) The payment differential of section 1848(a)(3) of such Act () shall apply to services furnished by non-participating physicians. The provisions of section 1848(g) of such Act () and section 1842(b)(18) of such Act () shall apply. Payment for such service shall be increased annually by the update factor for physicians’ services determined under section 1848(d) of such Act ().
“(c)

Supplemental Report .—

Not later than , the Secretary shall submit a report to Congress which shall contain a detailed analysis of—
“(1)
how telemedicine and telehealth systems are expanding access to health care services;
“(2)
the clinical efficacy and cost-effectiveness of telemedicine and telehealth applications;
“(3)
the quality of telemedicine and telehealth services delivered; and
“(4)
the reasonable cost of telecommunications charges incurred in practicing telemedicine and telehealth in rural, frontier, and underserved areas.
“(d)

Expansion of Telehealth Services for Certain Medicare Beneficiaries.—

“(1)

In general .—

42 U.S.C. 1395jNot later than , the Secretary shall submit a report to Congress that examines the possibility of making payments from the Federal Supplementary Medical Insurance Trust Fund under part B of title XVIII of the Social Security Act ( et seq.) for professional consultation via telecommunications systems with such a physician or practitioner furnishing a service for which payment may be made under such part to a beneficiary described in paragraph (2), notwithstanding that the individual physician or practitioner providing the professional consultation is not at the same location as the physician or practitioner furnishing the service to that beneficiary.
“(2)

Beneficiary described .—

42 U.S.C. 139542 U.S.C. 254e(a)(1)(A)A beneficiary described in this paragraph is a beneficiary under the medicare program under title XVIII of the Social Security Act ( et seq.) who does not reside in a rural area (as so defined) that is designated as a health professional shortage area under section 332(a)(1)(A) of the Public Health Service Act (), who is homebound or nursing homebound, and for whom being transferred for health care services imposes a serious hardship.
“(3)

Report .—

The report described in paragraph (1) shall contain a detailed statement of the potential costs and savings to the medicare program of making the payments described in that paragraph using various reimbursement schemes.”
, , , as amended by , , , 2763A–487, provided that:

Report on Coverage of Outpatient Occupational Therapy Services

Pub. L. 105–33, title IV, § 4541(d)(2)111 Stat. 457Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 221(c)(1)]113 Stat. 1536

“Not later than , the Secretary of Health and Human Services shall submit to Congress a report that includes recommendations on—
“(A)
42 U.S.C. 139542 U.S.C. 1395 the establishment of a mechanism for assuring appropriate utilization of outpatient physical therapy services, outpatient occupational therapy services, and speech-language pathology services that are covered under the medicare program under title XVIII of the Social Security Act () [ et seq.]; and
“(B)
42 U.S.C. 1395l the establishment of an alternative payment policy for such services based on classification of individuals by diagnostic category, functional status, prior use of services (in both inpatient and outpatient settings), and such other criteria as the Secretary determines appropriate, in place of the uniform dollar limitations specified in section 1833(g) of such Act [(g)], as amended by paragraph (1).
The recommendations shall include how such a mechanism or policy might be implemented in a budget-neutral manner.”
, , , as amended by , , , 1501A–351, provided that:

Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 221(c)(2)]113 Stat. 1536

section 4541(d)(2) of Pub. L. 105–33Pub. L. 105–33“The amendment made by paragraph (1) [amending , set out above] shall take effect as if included in the enactment of section 4541 of BBA [the Balanced Budget Act of 1997, ].”
[, , , 1501A–352, provided that: ]

Study and Report on Clinical Laboratory Tests

Pub. L. 105–33, title IV, § 4553(c)111 Stat. 46042 U.S.C. 1395j, , , required the Secretary to request the Institute of Medicine of the National Academy of Sciences to conduct a study of payments under part B of title XVIII of the Social Security Act ( et seq.) for clinical laboratory tests, including a review of the adequacy of the current methodology and recommendations regarding alternative payment systems analysis and of the relationship between such payment systems and access to high quality laboratory tests for medicare beneficiaries, including availability and access to new testing methodologies, and to report to Congress the results of the study and any recommendations for legislation not later than 2 years after ..”

Adjustments to Payment Amounts for New Technology Intraocular Lenses

Pub. L. 103–432, title I, § 141(b)108 Stat. 4425

“(1)

Establishment of process for review of amounts .—

42 U.S.C. 1395lNot later than 1 year after the date of the enactment of this Act [], the Secretary of Health and Human Services (in this subsection referred to as the ‘Secretary’) shall develop and implement a process under which interested parties may request review by the Secretary of the appropriateness of the reimbursement amount provided under section 1833(i)(2)(A)(iii) of the Social Security Act [(i)(2)(A)(iii)] with respect to a class of new technology intraocular lenses. For purposes of the preceding sentence, an intraocular lens may not be treated as a new technology lens unless it has been approved by the Food and Drug Administration.
“(2)

Factors considered .—

In determining whether to provide an adjustment of payment with respect to a particular lens under paragraph (1), the Secretary shall take into account whether use of the lens is likely to result in reduced risk of intraoperative or postoperative complication or trauma, accelerated postoperative recovery, reduced induced astigmatism, improved postoperative visual acuity, more stable postoperative vision, or other comparable clinical advantages.
“(3)

Notice and comment .—

The Secretary shall publish notice in the Federal Register from time to time (but no less often than once each year) of a list of the requests that the Secretary has received for review under this subsection, and shall provide for a 30-day comment period on the lenses that are the subjects of the requests contained in such notice. The Secretary shall publish a notice of the Secretary’s determinations with respect to intraocular lenses listed in the notice within 90 days after the close of the comment period.
“(4)

Effective date of adjustment .—

Any adjustment of a payment amount (or payment limit) made under this subsection shall become effective not later than 30 days after the date on which the notice with respect to the adjustment is published under paragraph (3).”
, , , provided that:

Study of Medicare Coverage of Patient Care Costs Associated With Clinical Trials of New Cancer Therapies

Pub. L. 103–432, title I, § 142108 Stat. 4426, , , directed Secretary of Health and Human Services to conduct a study, and to submit a report to Congress not later than 2 years after , of effects of expressly covering under medicare program patient care costs for beneficiaries enrolled in clinical trials of new cancer therapies, where protocol for the trial has been approved by the National Cancer Institute or met similar scientific and ethical standards, including approval by an institutional review board.

Study of Annual Cap on Amount of Medicare Payment for Outpatient Physical Therapy and Occupational Therapy Services

Pub. L. 103–432, title I, § 143108 Stat. 4426, , , directed Secretary of Health and Human Services to submit to Congress, not later than , study and report on appropriateness of continuing annual limitation on amount of payment for outpatient services of independently practicing physical and occupational therapists under medicare program, which was to include such recommendations for changes in such annual limitation as Secretary found appropriate.

Ambulatory Surgical Center Services; Inflation Update

Pub. L. 103–66, title XIII, § 13531107 Stat. 586

42 U.S.C. 1395l“The Secretary of Health and Human Services shall not provide for any inflation update in the payment amounts under subparagraphs (A) and (B) of section 1833(i)(2) of the Social Security Act [(i)(2)(A), (B)] for fiscal year 1994 or for fiscal year 1995.”
, , , provided that:

Freeze in Allowance for Intraocular Lenses

Pub. L. 103–66, title XIII, § 13533107 Stat. 587

42 U.S.C. 1395l“Notwithstanding section 1833(i)(2)(A)(iii) of the Social Security Act [(i)(2)(A)(iii)], the amount of payment determined under such section for an intraocular lens inserted subsequent to or during cataract surgery in an ambulatory surgical center on or after , and before , shall be equal to $150.”
, , , provided that:

Pub. L. 101–508, title IV, § 4151(c)(3)104 Stat. 1388–73Pub. L. 103–432, title I, § 141(d)108 Stat. 4426

42 U.S.C. 1395l“Notwithstanding section 1833(i)(2)(A)(iii) of the Social Security Act [(i)(2)(A)(iii)], the amount of payment determined under such section for an intraocular lens inserted during or subsequent to cataract surgery furnished to an individual in an ambulatory surgical center on or after the date of the enactment of this Act [] and on or before , shall be equal to $200.”
, , , as amended by , , , provided that:

Pub. L. 103–432, title I, § 141(d)108 Stat. 4426section 4151(c)(3) of Pub. L. 101–508Pub. L. 101–508[, , , provided that the amendment made by that section to , set out above, is effective as if included in the enactment of .]

Reduction in Payments Under Part B During Final Two Months of 1990

Pub. L. 101–508, title IV, § 4158104 Stat. 1388–89

“(a)

In General .—

42 U.S.C. 1395jNotwithstanding any other provision of law (including any other provision of this Act, other than subsection (b)(4)), payments under part B of title XVIII of the Social Security Act [ et seq.] for items and services furnished during the period beginning on , and ending on , shall be reduced by 2 percent, in accordance with subsection (b).
“(b)

Special Rules for Application of Reduction.—

“(1)

Payment on the basis of cost reporting periods .—

In the case in which payment for services of a provider of services is made under part B of such title on a basis relating to the reasonable cost incurred for the services during a cost reporting period of the provider, the reduction made under subsection (a) shall be applied to payment for costs for such services incurred at any time during each cost reporting period of the provider any part of which occurs during the period described in such subsection, but only in the same proportion as the fraction of the cost reporting period that occurs during such period.
“(2)

No increase in beneficiary charges in assignment-related cases .—

42 U.S.C. 1395u(i)(1)If a reduction in payment amounts is made under subsection (a) for items or services for which payment under part B of such title is made on an assignment-related basis (as defined in section 1842(i)(1) of the Social Security Act []), the person furnishing the items or services shall be considered to have accepted payment of the reasonable charge for the items or services, less any reduction in payment amount made under subsection (a), as payment in full.
“(3)

Treatment of payments to health maintenance organizations .—

42 U.S.C. 1395mmPub. L. 90–248section 1395b–1 of this titlellPub. L. 92–603llsection 1395b–1 of this titleSubsection (a) shall not apply to payments under risk-sharing contracts under section 1876 of the Social Security Act [] or under similar contracts under section 402 of the Social Security Amendments of 1967 [, enacting and amending section 1395 of this title] or section 222 of the Social Security Amendments of 1972 [, amending sections 1395b–1 and 1395 of this title and enacting provisions set out as a note under ].”
, , , provided that:

Effect on State Law

section 4206(c) of Pub. L. 101–508section 1395cc of this titleConscientious objections of health care provider under State law unaffected by enactment of subsecs. (a)(1)(Q) and (f) of this section, see , set out as a note under .

Development of Criteria Regarding Consultation With a Physician

Pub. L. 101–239, title VI, § 6113(c)103 Stat. 2217Pub. L. 103–432, title I, § 147(b)108 Stat. 4429

42 U.S.C. 1395j“The Secretary of Health and Human Services shall, taking into consideration concerns for patient confidentiality, develop criteria with respect to payment for qualified psychologist services and clinical social worker services for which payment may be made directly to the psychologist or clinical social worker under part B of title XVIII of the Social Security Act [ et seq.] under which such a psychologist or clinical social worker must agree to consult with a patient’s attending physician in accordance with such criteria.”
, , , as amended by , , , provided that:

Pub. L. 103–432, title I, § 147(b)108 Stat. 4429section 6113(c) of Pub. L. 101–239[, , , provided that the amendment made by that section to , set out above, is effective with respect to services furnished on or after .]

Study of Reimbursement for Ambulance Services

Pub. L. 101–239, title VI, § 6136103 Stat. 2222, , , directed Secretary of Health and Human Services to conduct a study to determine adequacy and appropriateness of payment amounts under this subchapter for ambulance services and, not later than one year after , submit a report to Congress on results of the study, with report to include such recommendations for changes in medicare payment policy with respect to ambulance services as may be needed to ensure access by medicare beneficiaries to quality ambulance services in metropolitan and rural areas.

PROPAC Study of Payments for Services in Hospital Outpatient Departments

Pub. L. 101–239, title VI, § 6137103 Stat. 2223Pub. L. 103–432, title I, § 147(c)(1)108 Stat. 4429, , , directed Prospective Payment Assessment Commission to conduct a study on payment under this subchapter for hospital outpatient services and, not later than , and not later than , to submit reports to Congress on specified portions of the study, with the reports to include such recommendations as the Commission deemed appropriate, prior to repeal by , , .

Budget Neutrality

Pub. L. 100–647, title VIII, § 8421(b)102 Stat. 3802

42 U.S.C. 1395l“The Secretary of Health and Human Services shall adjust the fees for transportation and personnel established under section 1833(h)(3)(B) of the Social Security Act [(h)(3)(B)] for tests not covered under the amendment made by subsection (a) [amending this section] in such manner that the total cost of fees under such section is the same as would have been the case without such amendment.”
, , , provided that:

Adjustment of Contracts With Prepaid Health Plans

Pub. L. 100–360section 222 of Pub. L. 100–360section 1395mm of this titleFor requirement that Secretary of Health and Human Services modify contracts under subsection (a)(1)(A) of this section to take into account amendments made by and that such organizations make appropriate adjustments in their agreements with medicare beneficiaries to take into account such amendments, see , set out as a note under .

Study and Report to Congress Respecting Incentive Payments for Physicians’ Services Furnished in Underserved Areas

Pub. L. 100–203, title IV, § 4043(b)101 Stat. 1330–86lPub. L. 101–508, title IV, § 4118(g)(1)104 Stat. 1388–70, , , directed Secretary of Health and Human Services to study and report to Congress, by not later than , on feasibility of making additional payments described in section 1395(m) of this title with respect to physician services performed in health manpower shortage areas located in urban areas, prior to repeal by , , .

Fee Schedules for Physician Pathology Services

Pub. L. 100–203, title IV, § 4050101 Stat. 1330–92Pub. L. 101–508, title IV, § 4104(b)(3)104 Stat. 1388–59, , , directed Secretary of Health and Human Services to develop a relative value scale and fee schedules with updating index for payment of physician pathology services under this part, and to report to committees of Congress not later than , on the scale, schedules, and index, prior to repeal by , , .

Applying Copayment and Deductible to Certain Outpatient Physicians’ Services

Pub. L. 100–203, title IV, § 4054101 Stat. 1330–98Pub. L. 100–360, title IV, § 411(f)(12)(A)102 Stat. 781, , , relating to payment under part B of title XVIII of the Social Security Act (this part) for physicians’ services specified in subsec. (i) of this section and furnished on or after , in an ambulatory surgical center or hospital outpatient department on an assignment-related basis, was negated in the amendment of section 4054 by , , .

Other Physician Payment Studies

Pub. L. 100–203, title IV, § 4056(c)101 Stat. 1330–99Pub. L. 100–360, title IV, § 411(f)(14)102 Stat. 781, formerly § 4055(c), , , as renumbered by , , , provided directed Secretary to (1) conduct a study of changes in the payment system for physicians’ services, under part B, that would be required for the implementation of a national fee schedule for such services furnished on or after , and report to Congress on such study by not later than , (2) conduct a study of issues relating to the volume and intensity of physicians’ services under part B and submit to Congress an interim report on such study not later than , and a final report on such study not later than , and (3) conduct a survey to determine distribution of (A) the liabilities and expenditures for health care services of individuals entitled to benefits under this subchapter, including liabilities for charges (not paid on an assignment-related basis) in excess of the reasonable charge recognized, and (B) the collection rates among different classes of physicians for such liabilities, including collection rates for required coinsurance and for charges (not paid on an assignment-related basis) in excess of the reasonable charge recognized, report to Congress on such study by not later than .

Study of Payment for Chemotherapy in Physicians’ Offices

Pub. L. 100–203, title IV, § 4056(d)101 Stat. 1330–99Pub. L. 100–360, title IV, § 411(f)(14)102 Stat. 781Pub. L. 105–362, title VI, § 601(b)(7)112 Stat. 3286, formerly § 4055(d), , , as renumbered by , , , directed Secretary to study ways of modifying part B to permit adequate payment under such part for costs associated with providing chemotherapy to cancer patients in physicians’ offices, with the Secretary to report to Congress on results of study by not later than , prior to repeal by , , .

Clinical Diagnostic Laboratory Tests; Limitation on Changes in Fee Schedules

Pub. L. 100–203, title IV, § 4064(a)101 Stat. 1330–110Pub. L. 100–360, title IV, § 411(g)(3)(A)102 Stat. 783, , , which provided 3-month freeze in fee schedules for clinical laboratory diagnostic laboratory tests under part B of title XVIII of the Social Security Act (this part) and directed the Secretary of Health and Human Services to not adjust the fee schedules established under subsec. (h) of this section to take into account any increase in the consumer price index, was negated in the amendment of section 4064(a) by , , .

GAO Study of Fee Schedules

Pub. L. 100–203, title IV, § 4064(b)(4)101 Stat. 1330–110section 1320a–7(a) of this title, , , directed Comptroller General to conduct a study of level of fee schedules established for clinical diagnostic laboratory services under subsec. (h)(2) of this section to determine, based on costs of, and revenues received for, such tests the appropriateness of such schedules, with Comptroller General to report to Congress on results of such study by not later than , and with provision that suppliers of such tests which fail to provide Comptroller General with reasonable access to necessary records to carry out study being subject to exclusion from the medicare program under .

Amounts Paid for Independent Rural Health Clinic Services

Pub. L. 100–203, title IV, § 4067(b)101 Stat. 1330–113

42 U.S.C. 1395“The Secretary of Health and Human Services shall report to Congress, by not later than , on the adequacy of the amounts paid under title XVIII of the Social Security Act [ et seq.] for rural health clinic services provided by independent rural health clinics.”
, , , provided that:

Report on Establishment of National Fee Schedules for Payment of Clinical Diagnostic Laboratory Tests

Pub. L. 99–509, title IX, § 9339(b)(3)100 Stat. 2036lPub. L. 101–508, title IV, § 4154(e)(3)104 Stat. 1388–86Pub. L. 99–509, , , directed Secretary of Health and Human Services to report to Congress, by not later than , on advisability and feasibility of, and methodology for, establishing national fee schedules for payment for clinical diagnostic laboratory tests under section 1395(h) of this title, prior to repeal by , , , effective as if included in enactment of .

State Standards for Directors of Clinical Laboratories

Pub. L. 99–509, title IX, § 9339(d)100 Stat. 2037

“(1)

In general .—

42 U.S.C. 1395If a State (as defined for purposes of title XVIII of the Social Security Act [ et seq.]) provides for the licensing or other standards with respect to the operation of clinical laboratories (including such laboratories in hospitals) in the State under which such a laboratory may be directed by an individual with certain qualifications, nothing in such title shall be construed as authorizing the Secretary of Health and Human Services to require such a laboratory, as a condition of payment or participation under such title, to be directed by an individual with other qualifications.
“(2)

Effective date .—

Paragraph (1) shall take effect on .”
, , , provided that:

Transitional Provisions for Payment of Fees for Clinical Diagnostic Laboratory Tests

Pub. L. 99–272, title IX, § 9303(a)(3)100 Stat. 188

42 U.S.C. 1395l“The Secretary of Health and Human Services shall provide that the annual adjustment under section 1833(h) of the Social Security Act [(h)] for 1986—
“(A)
shall take effect on ,
“(B)
shall apply for the 12-month period beginning on that date, and
“(C)
shall take into account the percentage increase or decrease in the Consumer Price Index for all urban consumers (United States city average) occurring over an 18-month period, rather than over a 12-month period.”
, , , provided that:

Extension of Medicare Physician Payment Provisions

section 5(b) of Pub. L. 99–107section 1395ww of this titleAmount of payment under this part for physicians’ services furnished between , and , to be determined on the same basis as the amount of such services furnished on , see , as amended, set out as a note under .

Fee Schedules for Diagnostic Laboratory Tests and Feasibility of Direct Payments to Physicians; Report to Congress

Pub. L. 98–369, div. B, title III, § 2303(i)98 Stat. 1066

“(1)
The Comptroller General shall report to the Congress on—
“(A)
42 U.S.C. 1395l the appropriateness of the fee schedules under section 1833(h) of the Social Security Act [(h)] and their impact on the volume and quality of clinical diagnostic laboratory tests;
“(B)
the potential impact of the adoption of a national fee schedule; and
“(C)
the potential impact of applying a national fee schedule to clinical diagnostic laboratory tests provided by hospitals to their outpatients.
“(2)
The Secretary of Health and Human Services shall report to the Congress with respect to the advisability and feasibility of a system of direct payment to any physician for all clinical diagnostic laboratory tests ordered by such physician.
“(3)
The reports required by paragraphs (1) and (2) shall be submitted not later than .”
, , , provided that:

Pacemaker Reimbursement Review and Reform

Pub. L. 98–369, div. B, title III, § 2304(a)98 Stat. 1067

“(1)
42 U.S.C. 1395j The Secretary of Health and Human Services shall issue revisions to the current guidelines for the payment under part B of title XVIII of the Social Security Act [ et seq.] for the transtelephonic monitoring of cardiac pacemakers. Such revised guidelines shall include provisions regarding the specifications for and frequency of transtelephonic monitoring procedures which will be found to be reasonable and necessary.
“(2)
(A)
Except as provided in subparagraph (B), if the guidelines required by paragraph (1) have not been issued and put into effect by , and until such guidelines have been issued and put into effect, payment may not be made under part B of title XVIII of the Social Security Act for transtelephonic monitoring procedures, with respect to a single-chamber cardiac pacemaker powered by lithium batteries, conducted more frequently than—
“(i)
weekly during the first month after implantation,
“(ii)
once every two months during the period representing 80 percent of the estimated life of the implanted device, and
“(iii)
monthly thereafter.
“(B)
Subparagraph (A) shall not apply in cases where the Secretary determines that special medical factors (including possible evidence of pacemaker or lead malfunction) justify more frequent transtelephonic monitoring procedures.”
, , , provided that:

Payment for Preadmission Diagnostic Testing Performed in Physician’s Office

Pub. L. 98–369, div. B, title III, § 2305(f)98 Stat. 1070

42 U.S.C. 1395j“The amendments made by this section [amending this section and enacting provisions set out above] shall not be construed as prohibiting payment, subject to the applicable copayments, under part B of title XVIII of the Social Security Act [ et seq.] for preadmission diagnostic testing performed in a physician’s office to the extent such testing is otherwise reimbursable under regulations of the Secretary.”
, , , provided that:

Providers of Services To Calculate and Report Lesser-of-Cost-or-Charges Determinations Separately With Respect to Payments Under Parts A and B of This Subchapter; Issuance of Regulations

section 2308(a) of Pub. L. 98–369section 1395f of this titleFor provision directing the Secretary to issue regulations requiring providers of services to calculate and report the lesser-of-cost-or-charges determinations separately with respect to payments for services under parts A and B of this subchapter other than diagnostic tests under subsec. (h) of this section, see , set out as a note under .

Determination of Nominal Charges for Applying Nominality Test

section 2308(b)(1) of Pub. L. 98–369section 1395f of this titleFor provision directing the Secretary to provide, in addition to other rules deemed appropriate, that charges representing 60 percent or less of costs be considered nominal for purposes of applying the nominality test under subsec. (a)(2)(B)(ii) of this section, see , set out as a note under .

Study of Medicare Part B Payments; Compilation of Centralized Charge Data Base; Report to Congress

Pub. L. 98–369, div. B, title III, § 230998 Stat. 1074, , , directed Director of Office of Technology Assessment to conduct a study of physician reimbursement under the Medicare program and make a report not later than , covering findings and recommendations on methods by which payment amounts and other program policies under the program might be modified, and directed that Secretary of Health and Human Services compile a centralized Medicare part B charge data base to aid in the study.

Monitoring Provision of Hepatitis B Vaccine; Review of Changes in Medical Technology

Pub. L. 98–369, div. B, title III, § 2323(e)98 Stat. 1086

42 U.S.C. 1395j“The Secretary shall monitor the provision of hepatitis B vaccine under part B of title XVIII of the Social Security Act [ et seq.], and shall review any changes in medical technology which may have an effect on the amounts which should be paid for such service.”
, , , provided that:

Report on Preadmission Diagnostic Testing Expenses

Pub. L. 96–499, title IX, § 932(b)94 Stat. 2635, , , required a report to Congress, no later than one year after , on the policy respecting expenses incurred for preadmission diagnostic testing furnished to an individual at a hospital within seven days of an individual’s admission to another hospital.

Study of Feasibility and Desirability of Imposing Copayment Requirement on Rural Health Clinic Visits; Report Not Later Than

Pub. L. 95–210, § 1(c)91 Stat. 1485, , , directed Secretary of Health, Education, and Welfare to conduct a study of the feasibility and desirability of imposing a copayment for each visit to a rural health clinic for rural health clinic services under this part and that Secretary report to appropriate committee of Congress, not later than one year after , on such study.

Prohibition Against Payments in Cases of Nonenti­tlement to Monthly Benefits Under Subchapter II or Suspension of Benefits of Aliens Outside the United States

Pub. L. 89–97, title I, § 104(b)(1)79 Stat. 334

42 U.S.C. 1395j42 U.S.C. 40142 U.S.C. 402(t)“No payments shall be made under part B of title XVIII of the Social Security Act [ et seq.] with respect to expenses incurred by an individual during any month for which such individual may not be paid monthly benefits under title II of such Act [ et seq.] (or for which such monthly benefits would be suspended if he were otherwise entitled thereto) by reason of section 202(t) of such Act [] (relating to suspension of benefits of aliens who are outside the United States).”
, , , provided that: