42 CFR § 420.304 - Procedures for obtaining access to books, documents, and records.
(a) Contents of the request. Requests for access will be in writing and contain the following elements:
(1) Reasonable identification of the books, documents, and records to which access is being requested.
(2) Identification of the contract or subcontract in which costs are being questioned as excessive or inappropriate.
(3) The reason that the appropriateness of the costs or value of the services of the subcontractor in question cannot be adequately or efficiently determined without access to the subcontractor's books and records.
(4) The authority in the statute and regulations for the access requested.
(5) To the extent possible, the identification of those individuals who will be visiting the subcontractor to obtain access to the books, documents, and records.
(6) The time and date of the scheduled visit.
(7) The name of the duly authorized representative of HHS to contact if there are any questions.
(b) Subcontractor response to a request for access to books, documents, and records.
(1) The subcontractor will have 30 days from the date of a written request for access to books, documents, and records to make them available in accordance with the request.
(2) If the subcontractor believes the request is inadequate because it does not fully meet one or more of the required elements in paragraph (a) of this section, the subcontractor must advise the requesting organization of the additional information needed.
(i) The subcontractor must notify the requesting organization within 20 days of the date of the request that it was improperly completed.
(ii) The subcontractor must make the books, documents, and records available within 20 days after the date of the requesting organization's response.
(3) If the subcontractor believes, for good cause, that the requested books, documents, and records cannot be made available as requested with the 30-day period under paragraph (b)(1) of this section, the subcontractor may request an extension of time within which to comply with the request from the requesting organization. The requesting organization may, at its discretion, grant the request for an extension, in whole or in part, for good cause shown.
(4) The subcontractor must make the books, documents, and records available during its regular business hours for inspection, audit, and reproduction.
(5) If HHS asks the subcontractor to reproduce books, documents, and records, HHS will pay the reasonable cost of reproduction. However, if the subcontractor reproduces books, documents, and records as a means of making them available, the subcontractor must bear the cost of the reproduction and no Medicare reimbursement will be made for that purpose.
(6) HHS reserves the right to examine the originals of any requested contracts, books, documents, and records, if they exist.
(c) Refusal by subcontractor to furnish access to records. If CMS determines that the books, documents, and records are necessary for the reimbursement determination and the subcontractor refuses to make them available, HHS may initiate legal action against the subcontractor.