AM and Applicable GPO (Record Retention)

OMB Control No.: 0938-1237
Expiration Date: XX/2020

42 CFR Parts 402 and 403 Medicare, Medicaid, Children’s Health Insurance Programs;
Transparency Reports and Reporting of Physician Ownership or Investment Interests; Final Rule
(February 8, 2013)
42 C.F.R. § 403.912(e) Record retention and audits. (1) Maintenance of records. (i) Applicable
manufacturers and applicable group purchasing organizations must maintain all books, contracts, records,
documents, and other evidence sufficient to enable the audit, evaluation, and inspection of the applicable
manufacturer’s or applicable group purchasing organization’s compliance with the requirement to timely,
accurately or completely submit information in accordance with the rules established under this subpart.
(ii) The items described in paragraph (e)(1)(i) of this section must be maintained for a period of at least 5
years from the date the payment or other transfer of value, or ownership or investment interest is
published publicly on the Web site.
78 Fed. Reg. 9506-7
Finally, we proposed that in order to facilitate audits and enforcement, applicable manufacturers and
applicable GPOs must maintain all books, records, documents, and other materials sufficient to enable an
audit, evaluation or inspection of the applicable manufacturer’s or applicable GPO’s compliance with the
requirements in section 1128G of the Act and the implementing regulations. We proposed that applicable
manufacturers and applicable GPOs must maintain these books, records, documents, and other materials
for a period of at least 5 years from the date the payment or other transfer of value, or ownership or
investment interest is published publicly on the Web site.