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

Summary

Drug makers that don’t follow the price, rebate, or reporting rules must pay big fines. If a maker that agreed to the program does not give the required maximum fair price to eligible patients or their providers, the maker must pay a penalty equal to ten times the number of drug units involved multiplied by the price difference. If a maker fails to pay required rebates, the penalty is ten times the unpaid rebate. If a maker breaks certain reporting or agreement duties, the penalty is $1,000,000 for each day they are in violation. If a maker knowingly gives false information, the penalty is $100,000,000 for each false item. Normal rules for enforcing civil money penalties apply to these fines in the same way they do for similar penalties.

Title 42, §1320f–6

The Public Health and Welfare, Source: USLM XML via OLRC

(a)Violations relating to offering of maximum fair price

(1)to a maximum fair price eligible individual who with respect to such drug is described in subparagraph (A) of section 1320f(c)(2) of this title 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

Any manufacturer that fails to comply with the rebate requirements under section 1320f–1(f)(4) of this title 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

Any manufacturer of a selected drug that has entered into an agreement under section 1320f–2 of this title, 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 section 1320f–2(a)(5) of this title, including the requirement to submit information pursuant to section 1320f–2(a)(4) of this title, shall be subject to a civil monetary penalty equal to $1,000,000 for each day of such violation.

(d)False information

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

(e)Application

The provisions of section 1320a–7a of this title (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 section 1320a–7a(a) of this title.

Editorial Notes

Amendments

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

§1320f–6 Civil Monetary Penalties

Summary

Title 42, §1320f–6

Notes & Related Subsidiaries

Editorial Notes

Amendments

Citations & Metadata