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

  1. Law
  2. CFR 42
  3. Public Health
  4. Centers for Medicare & Medicaid Services, Department of Health and Human Services
  5. Medicare Program
  6. Payment for Part B Medical and Other Health Services
  7. Submission of Manufacturer's Average Sales Price Data
  8. Penalties associated with misrepresentation and the failure to submit timely and accurate ASP data.

Checkout our iOS App for a better way to browser and research.

§ 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.

[86 FR 65669, Nov. 19, 2021]


Download our app to see the most-to-date content.