§414.806. Penalties associated with misrepresentation and the failure to submit timely and accurate ASP data.
42 C.F.R. § 414.806
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.
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.
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.
Notes, amendments, and revision history
Amendments
[86 FR 65669, Nov. 19, 2021]
Source
Source: 69 FR 17938, Apr. 6, 2004, unless otherwise noted.
Authority
Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).
Source
Source: 55 FR 23441, June 8, 1990, unless otherwise noted.
Amendments
[86 FR 65669, Nov. 19, 2021]