§ 414.806 - Penalties associated with misrepresentation and the failure to submit timely and accurate ASP data.

§ 414.806 Penalties associated with misrepresentation and the failure to submit timely and accurate ASP data.

Cross Reference

Link to an amendment published at 86 FR 65669, Nov. 19, 2021.

(a) Misrepresentation . Section 1847A(d)(4)(A) of the Act specifies the penalties associated with misrepresentations

associated with ASP data. If the Secretary determines that a manufacturer has made a misrepresentation in the reporting of ASP data, a civil money penalty in an amount of up to $10,000 may be applied for each price misrepresentation and for each day in which the price misrepresentation was applied. Section

in the reporting of the manufacturer's average sales price for a drug as defined at § 414.802.

(b) Failure to provide timely information or the submission of false information .

(1) For a manufacturer that has entered into and has in effect a rebate agreement under section 1927 of the Act, section 1927(b)(3)(C) of the Act

, as amended by section 303(i

specifies the penalties associated with a manufacturer's failure to submit timely information or the submission of false information.

(2) For a manufacturer that has not entered into and does not have in effect a rebate agreement under section 1927 of the Act, sections 1847A(d)(4)(B) and (C) of the

MMA, specifies

Act specify the penalties associated with a manufacturer's failure to submit timely information or the submission of false information.

[86 FR 65669, Nov. 19, 2021]