42 CFR 414.806 – Penalties associated with misrepresentation and the failure to submit timely and accurate ASP data
(a) Misrepresentation. Section 1847A(d)(4)(A) of the Act specifies the penalties associated with misrepresentations 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 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 Act specify the penalties associated with a manufacturer’s failure to submit timely information or the submission of false information.