42 C.F.R. Subpart I—Payment for Outpatient Prescription Drugs Under Drug Rebate Agreements
Title 42 - Public Health
Source: 68 FR 51917, Aug. 29, 2003, unless otherwise noted.
Title 42: Public Health
PART 447—PAYMENTS FOR SERVICES
Subpart I—Payment for Outpatient Prescription Drugs Under Drug Rebate Agreements
§§ 447.500-447.532 [Reserved]
§ 447.534 Manufacturer reporting requirements.
(a)–(g) [Reserved]
(h) Recordkeeping requirements. (1)(i) A manufacturer must retain records (written or electronic) for 10 years from the date the manufacturer reports data to CMS for that rebate period. The records must include these data and any other materials from which the calculations of the average manufacturer price and best price are derived, including a record of any assumptions made in the calculations. The 10-year timeframe applies to a manufacturer's quarterly submission of pricing data, as well as any revised pricing data subsequently submitted to CMS.
(ii) A manufacturer must retain records beyond the 10-year period if both of the following circumstances exist:
(A) The records are the subject of an audit or of a government investigation related to pricing data that are used in average manufacturer price or best price of which the manufacturer is aware.
(B) The audit findings or investigation related to the average manufacturer price and best price have not been resolved.
(2) [Reserved]
(i) Timeframe for reporting revised average manufacturer price or best price. A manufacturer must report to CMS revisions to average manufacturer price or best price for a period not to exceed 12 quarters from the quarter in which the data were due.
[68 FR 51917, Aug. 29, 2003, as amended at 69 FR 513, Jan. 6, 2004; 69 FR 68818, Nov. 26, 2004]
