State option
In general
“PACE program” defined
Operation
The entity operating the program is a PACE provider (as defined in paragraph (3)).
Comprehensive benefits
The program provides comprehensive health care services to PACE program eligible individuals in accordance with the PACE program agreement and regulations under this section.
Transition
In the case of an individual who is enrolled under the program under this section and whose enrollment ceases for any reason (including that the individual no longer qualifies as a PACE program eligible individual, the termination of a PACE program agreement, or otherwise), the program provides assistance to the individual in obtaining necessary transitional care through appropriate referrals and making the individual’s medical records available to new providers.
“PACE provider” defined
In general
Treatment of private, for-profit providers
“PACE program agreement” defined
section 1395eee of this titleFor purposes of this section, the term “PACE program agreement” means, with respect to a PACE provider, an agreement, consistent with this section, (if applicable), and regulations promulgated to carry out such sections, among the PACE provider, the Secretary, and a State administering agency for the operation of a PACE program by the provider under such sections.
“PACE program eligible individual” defined
“PACE protocol” defined
For purposes of this section, the term “PACE protocol” means the Protocol for the Program of All-inclusive Care for the Elderly (PACE), as published by On Lok, Inc., as of , or any successor protocol that may be agreed upon between the Secretary and On Lok, Inc.
“PACE demonstration waiver program” defined
“State administering agency” defined
section 1395eee of this titleFor purposes of this section, the term “State administering agency” means, with respect to the operation of a PACE program in a State, the agency of that State (which may be the single agency responsible for administration of the State plan under this subchapter in the State) responsible for administering PACE program agreements under this section and in the State.
“Trial period” defined
In general
For purposes of this section, the term “trial period” means, with respect to a PACE program operated by a PACE provider under a PACE program agreement, the first 3 contract years under such agreement with respect to such program.
Treatment of entities previously operating PACE demonstration waiver programs
Each contract year (including a year occurring before the effective date of this section) during which an entity has operated a PACE demonstration waiver program shall be counted under subparagraph (A) as a contract year during which the entity operated a PACE program as a PACE provider under a PACE program agreement.
“Regulations” defined
section 1395eee of this titleFor purposes of this section, the term “regulations” refers to interim final or final regulations promulgated under subsection (f) to carry out this section and .
Scope of benefits; beneficiary safeguards
In general
Quality assurance; patient safeguards
Treatment of medicare services furnished by noncontract physicians and other entities
Application of medicare advantage requirement with respect to medicare services furnished by noncontract physicians and other entities
Section 1395w–22(k)(1) of this title (relating to limitations on balance billing against MA organizations for noncontract physicians and other entities with respect to services covered under subchapter XVIII) shall apply to PACE providers, PACE program eligible individuals enrolled with such PACE providers, and physicians and other entities that do not have a contract or other agreement establishing payment amounts for services furnished to such an individual in the same manner as such section applies to MA organizations, individuals enrolled with such organizations, and physicians and other entities referred to in such section.
Reference to related provision for noncontract providers of services
section 1395cc(a)(1)(O) of this titleFor the provision relating to limitations on balance billing against PACE providers for services covered under subchapter XVIII furnished by noncontract providers of services, see .
Reference to related provision for services covered under this subchapter but not under subchapter XVIII
section 1396a(a)(67) of this titleFor provisions relating to limitations on payments to providers participating under the State plan under this subchapter that do not have a contract or other agreement with a PACE provider establishing payment amounts for services covered under such plan (but not under subchapter XVIII) when such services are furnished to enrollees of that PACE provider, see .
Eligibility determinations
In general
Condition
An individual is not a PACE program eligible individual (with respect to payment under this section) unless the individual’s health status has been determined by the Secretary or the State administering agency, in accordance with regulations, to be comparable to the health status of individuals who have participated in the PACE demonstration waiver programs. Such determination shall be based upon information on health status and related indicators (such as medical diagnoses and measures of activities of daily living, instrumental activities of daily living, and cognitive impairment) that are part of a uniform minimum data set collected by PACE providers on potential eligible individuals.
Annual eligibility recertifications
In general
Subject to subparagraph (B), the determination described in subsection (a)(5)(B) for an individual shall be reevaluated at least annually.
Exception
The requirement of annual reevaluation under subparagraph (A) may be waived during a period in accordance with regulations in those cases in which the State administering agency determines that there is no reasonable expectation of improvement or significant change in an individual’s condition during the period because of the severity of chronic condition, or degree of impairment of functional capacity of the individual involved.
Continuation of eligibility
An individual who is a PACE program eligible individual may be deemed to continue to be such an individual notwithstanding a determination that the individual no longer meets the requirement of subsection (a)(5)(B) if, in accordance with regulations, in the absence of continued coverage under a PACE program the individual reasonably would be expected to meet such requirement within the succeeding 6-month period.
Enrollment; disenrollment
Voluntary disenrollment at any time
The enrollment and disenrollment of PACE program eligible individuals in a PACE program shall be pursuant to regulations and the PACE program agreement and shall permit enrollees to voluntarily disenroll without cause at any time.
Limitations on disenrollment
In general
No disenrollment for noncompliant behavior
Except as allowed under regulations promulgated to carry out clause (i)(II), a PACE program may not disenroll a PACE program eligible individual on the ground that the individual has engaged in noncompliant behavior if such behavior is related to a mental or physical condition of the individual. For purposes of the preceding sentence, the term “noncompliant behavior” includes repeated noncompliance with medical advice and repeated failure to appear for appointments.
Timely review of proposed nonvoluntary disenrollment
A proposed disenrollment, other than a voluntary disenrollment, shall be subject to timely review and final determination by the Secretary or by the State administering agency (as applicable), prior to the proposed disenrollment becoming effective.
Payments to PACE providers on a capitated basis
In general
In the case of a PACE provider with a PACE program agreement under this section, except as provided in this subsection or by regulations, the State shall make prospective monthly payments of a capitation amount for each PACE program eligible individual enrolled under the agreement under this section.
Capitation amount
section 1395eee of this titleThe capitation amount to be applied under this subsection for a provider for a contract year shall be an amount specified in the PACE program agreement for the year. Such amount shall be an amount, specified under the PACE agreement, which is less than the amount that would otherwise have been made under the State plan if the individuals were not so enrolled and shall be adjusted to take into account the comparative frailty of PACE enrollees and such other factors as the Secretary determines to be appropriate. The payment under this section shall be in addition to any payment made under for individuals who are enrolled in a PACE program under such section.
PACE program agreement
Requirement
In general
section 1395eee of this titleThe Secretary, in close cooperation with the State administering agency, shall establish procedures for entering into, extending, and terminating PACE program agreements for the operation of PACE programs by entities that meet the requirements for a PACE provider under this section, , and regulations.
Numerical limitation
In general
Treatment of certain private, for-profit providers
Service area and eligibility
In general
Service area overlap
In designating a service area under a PACE program agreement under subparagraph (A)(i), the Secretary (in consultation with the State administering agency) may exclude from designation an area that is already covered under another PACE program agreement, in order to avoid unnecessary duplication of services and avoid impairing the financial and service viability of an existing program.
Data collection; development of outcome measures
Data collection
In general
Requirements during trial period
During the first 3 years of operation of a PACE program (either under this section or under a PACE demonstration waiver program), the PACE provider shall provide such additional data as the Secretary specifies in regulations in order to perform the oversight required under paragraph (4)(A).
Development of outcome measures
Under a PACE program agreement, the PACE provider, the Secretary, and the State administering agency shall jointly cooperate in the development and implementation of health status and quality of life outcome measures with respect to PACE program eligible individuals.
Oversight
Annual, close oversight during trial period
Continuing oversight
After the trial period, the Secretary (in cooperation with the State administering agency) shall continue to conduct such review of the operation of PACE providers and PACE programs as may be appropriate, taking into account the performance level of a provider and compliance of a provider with all significant requirements of this section and regulations.
Disclosure
The results of reviews under this paragraph shall be reported promptly to the PACE provider, along with any recommendations for changes to the provider’s program, and shall be made available to the public upon request.
Termination of PACE provider agreements
In general
Causes for termination
Termination and transition procedures
An entity whose PACE provider agreement is terminated under this paragraph shall implement the transition procedures required under subsection (a)(2)(C).
Secretary’s oversight; enforcement authority
In general
Application of intermediate sanctions
section 1395mm(i)(6)(B) of this titlesection 1395eee of this titleUnder regulations, the Secretary may provide for the application against a PACE provider of remedies described in section 1395w–27(g)(2) (or, for periods before , ) or 1396b(m)(5)(B) of this title in the case of violations by the provider of the type described in section 1395w–27(g)(1) (or 1395mm(i)(6)(A) of this title for such periods) or 1396b(m)(5)(A) of this title, respectively (in relation to agreements, enrollees, and requirements under or this section, respectively).
Procedures for termination or imposition of sanctions
section 1395w–27(h) of this titlesection 1395mm(i)(9) of this titlesection 1395mm of this titleUnder regulations, the provisions of (or for periods before , ) shall apply to termination and sanctions respecting a PACE program agreement and PACE provider under this subsection in the same manner as they apply to a termination and sanctions with respect to a contract and a Medicare+Choice organization under part C of subchapter XVIII (or for such periods an eligible organization under ).
Timely consideration of applications for PACE program provider status
In considering an application for PACE provider program status, the application shall be deemed approved unless the Secretary, within 90 days after the date of the submission of the application to the Secretary, either denies such request in writing or informs the applicant in writing with respect to any additional information that is needed in order to make a final determination with respect to the application. After the date the Secretary receives such additional information, the application shall be deemed approved unless the Secretary, within 90 days of such date, denies such request.
Regulations
In general
section 1395eee of this titleThe Secretary shall issue interim final or final regulations to carry out this section and .
Use of PACE protocol
In general
In issuing such regulations, the Secretary shall, to the extent consistent with the provisions of this section, incorporate the requirements applied to PACE demonstration waiver programs under the PACE protocol.
Flexibility
Continuation of modifications or waivers of operational requirements under demonstration status
1
Application of certain additional beneficiary and program protections
In general
section 1395mm of this titlesection 1395mm of this titlesection 1396b(m) of this titleIn issuing such regulations and subject to subparagraph (B), the Secretary may apply with respect to PACE programs, providers, and agreements such requirements of part C of subchapter XVIII (or, for periods before , ) and sections 1396b(m) and 1396u–2 of this title relating to protection of beneficiaries and program integrity as would apply to Medicare+Choice organizations under such part C (or for such periods eligible organizations under risk-sharing contracts under ) and to medicaid managed care organizations under prepaid capitation agreements under .
Considerations
Construction
Nothing in this subsection shall be construed as preventing the Secretary from including in regulations provisions to ensure the health and safety of individuals enrolled in a PACE program under this section that are in addition to those otherwise provided under paragraphs (2) and (3).
Waivers of requirements
Demonstration project for for-profit entities
In general
In order to demonstrate the operation of a PACE program by a private, for-profit entity, the Secretary (in close consultation with State administering agencies) shall grant waivers from the requirement under subsection (a)(3) that a PACE provider may not be a for-profit, private entity.
Similar terms and conditions
In general
Except as provided under subparagraph (B), and paragraph (1), the terms and conditions for operation of a PACE program by a provider under this subsection shall be the same as those for PACE providers that are nonprofit, private organizations.
Numerical limitation
The number of programs for which waivers are granted under this subsection shall not exceed 10. Programs with waivers granted under this subsection shall not be counted against the numerical limitation specified in subsection (e)(1)(B).
Post-eligibility treatment of income
section 1396n(c) of this titleA State may provide for post-eligibility treatment of income for individuals enrolled in PACE programs under this section in the same manner as a State treats post-eligibility income for individuals receiving services under a waiver under .
Miscellaneous provisions
section 1395eee of this titleNothing in this section or shall be construed as preventing a PACE provider from entering into contracts with other governmental or nongovernmental payers for the care of PACE program eligible individuals who are not eligible for benefits under part A, or enrolled under part B, of subchapter XVIII or eligible for medical assistance under this subchapter.
Aug. 14, 1935, ch. 531Pub. L. 105–33, title IV, § 4802(a)(3)111 Stat. 539Pub. L. 106–554, § 1(a)(6) [title IX, § 902(b)]114 Stat. 2763Pub. L. 108–173, title II, § 236(b)(2)117 Stat. 2211(, title XIX, § 1934, as added , , ; amended , , , 2763A–583; , , .)
Editorial Notes
References in Text
The Internal Revenue Code of 1986, referred to in subsec. (a)(3)(A)(i), is classified generally to Title 26, Internal Revenue Code.
Pub. L. 105–33111 Stat. 251section 1395eee of this titleThe Balanced Budget Act of 1997, referred to in subsecs. (a)(3)(B)(ii) and (g)(5), is , , . Section 4804(b) of the Act is set out as a note under . For complete classification of this Act to the Code, see Tables.
section 603(c) of Pub. L. 98–2197 Stat. 168Pub. L. 105–33, title IV, § 4803(d)111 Stat. 550Section 603(c) of the Social Security Amendments of 1983, referred to in subsec. (a)(7)(A), is , title VI, , , which was not classified to the Code and was repealed by , , , subject to transition provisions.
section 9220 of Pub. L. 99–272100 Stat. 183Pub. L. 105–33, title IV, § 4803(d)111 Stat. 550Section 9220 of the Consolidated Omnibus Budget Reconciliation Act of 1985, referred to in subsec. (a)(7)(A), is , title IX, , , which was not classified to the Code and was repealed by , , , subject to transition provisions.
section 9412(b) of Pub. L. 99–509100 Stat. 2062Pub. L. 105–33, title IV, § 4803(d)111 Stat. 550Section 9412(b) of the Omnibus Budget Reconciliation Act of 1986, referred to in subsecs. (a)(7)(B) and (e)(1)(B)(i), is , title IX, , , which was not classified to the Code and was repealed by , , , subject to transition provisions.
section 4803 of Pub. L. 105–33section 1395eee of this titleFor the effective date of this section, referred to in subsec. (a)(9)(B), see , set out as a Transition; Regulations note under .
Prior Provisions
section 1396v of this titleA prior section 1934 of act , was renumbered section 1939 and is classified to .
Amendments
Pub. L. 108–1732003—Subsec. (b)(3), (4). added pars. (3) and (4).
Pub. L. 106–5542000—Subsec. (f)(2)(C). added subpar. (C).
Statutory Notes and Related Subsidiaries
Change of Name
section 201 of Pub. L. 108–173section 1395w–21 of this titleReferences to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see , set out as a note under .
Effective Date of 2003 Amendment
Pub. L. 108–173section 236(c) of Pub. L. 108–173section 1395cc of this titleAmendment by applicable to services furnished on or after , see , set out as a note under .
Effective Date of 2000 Amendment
Pub. L. 106–554Pub. L. 105–33Pub. L. 106–554section 1395eee of this titleAmendment by effective as if included in the enactment of , see section 1(a)(6) [title IX, § 902(c)] of , set out as a note under .