42 U.S.C. § 1320f–6 | Civil monetary penalties

(a)

Violations relating to offering of maximum fair price

section 1320f–2 of this titleAny manufacturer of a selected drug that has entered into an agreement under , with respect to a year during the price applicability period with respect to such drug, that does not provide access to a price that is equal to or less than the maximum fair price for such drug for such year—

(1)

section 1320f(c)(2) of this title to a maximum fair price eligible individual who with respect to such drug is described in subparagraph (A) of and who is dispensed such drug during such year (and to pharmacies, mail order services, and other dispensers, with respect to such maximum fair price eligible individuals who are dispensed such drugs); or

(2)

to a hospital, physician, or other provider of services or supplier with respect to maximum fair price eligible individuals who with respect to such drug is described in subparagraph (B) of such section and is furnished or administered such drug by such hospital, physician, or provider or supplier during such year;

shall be subject to a civil monetary penalty equal to ten times the amount equal to the product of the number of units of such drug so furnished, dispensed, or administered during such year and the difference between the price for such drug made available for such year by such manufacturer with respect to such individual or hospital, physician, provider of services, or supplier and the maximum fair price for such drug for such year.

(b)

Violations relating to providing rebates

section 1320f–1(f)(4) of this titleAny manufacturer that fails to comply with the rebate requirements under shall be subject to a civil monetary penalty equal to 10 times the amount of the rebate the manufacturer failed to pay under such section.

(c)

Violations of certain terms of agreement

section 1320f–2 of this title section 1320f–2(a)(5) of this title section 1320f–2(a)(4) of this titleAny manufacturer of a selected drug that has entered into an agreement under , with respect to a year during the price applicability period with respect to such drug, that is in violation of a requirement imposed pursuant to , including the requirement to submit information pursuant to , shall be subject to a civil monetary penalty equal to $1,000,000 for each day of such violation.

(d)

False information

section 1320f–5(a)(7) of this titleAny manufacturer that knowingly provides false information pursuant to shall be subject to a civil monetary penalty equal to $100,000,000 for each item of such false information.

(e)

Application

section 1320a–7a of this title section 1320a–7a(a) of this titleThe provisions of (other than subsections (a) and (b)) shall apply to a civil monetary penalty under this section in the same manner as such provisions apply to a penalty or proceeding under .

Aug. 14, 1935, ch. 531 Pub. L. 117–169, title IAug. 16, 2022136 Stat. 1850(, title XI, § 1197, as added and amended , §§ 11001(a), 11002(a)(4), , , 1861.)

Editorial Notes

Amendments

Pub. L. 117–169, § 11002(a)(4)2022—Subsecs. (b) to (e). , added subsec. (b) and redesignated former subsecs. (b) to (d) as (c) to (e), respectively.