Code of Federal Regulations (Last Updated: May 6, 2024) |
Title 42 - Public Health |
Chapter IV - Centers for Medicare & Medicaid Services, Department of Health and Human Services |
SubChapter B - Medicare Program |
Part 414 - Payment for Part B Medical and Other Health Services |
Subpart J - Submission of Manufacturer's Average Sales Price Data |
§ 414.806 - Penalties associated with misrepresentation and the failure to submit timely and accurate ASP data.
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§ 414.806 Penalties associated with misrepresentation and the failure to submit timely and accurate ASP data.
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(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.
, as amended by section 303(i(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
MMA, specifiesspecifies 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]