PRIA, Government Policy, Made Personal

Summary

Makes drug makers pay money penalties when they break price or reporting rules in their agreements. If a manufacturer does not give the required lower price to covered patients, pharmacies, hospitals, or other providers during the year the price rules apply, the company must pay a monetary penalty. If a manufacturer fails to pay required rebates, it must pay a fine equal to 10 times the unpaid rebate amount. If a manufacturer breaks reporting or information rules tied to its agreement, it must pay $1,000,000 for each day it is in violation. If a manufacturer knowingly gives false information, it must pay $100,000,000 for each false item. Other general federal penalty procedures (except two specific parts) apply to how these fines are handled.

Title 42, §1320f–6

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

(a)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 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)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;

(b)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)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)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)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