42 C.F.R. § 423.165 Compliance deemed on the basis of accreditation.
Title 42 - Public Health
(a) General rule. A Part D sponsor is deemed to meet all of the requirements of any of the areas described in paragraph (b) of this section if— (1) The Part D sponsor is fully accredited (and periodically reaccredited) for the standards related to the applicable area under paragraph (b) of this section by a private, national accreditation organization approved by CMS; and (2) The accreditation organization uses the standards approved by CMS for the purposes of assessing the Part D sponsor's compliance with Medicare requirements. (b) Deemable requirements. The requirements relating to the following areas are deemable: (1) Access to covered drugs, as provided under §423.120 and §423.124. (2) Drug utilization management programs, quality assurance measures and systems, and MTMPs as provided under §423.153. (3) Privacy, confidentiality, and accuracy of enrollee records, as provided under §423.136. (4) A program to protect against fraud, waste and abuse, as described in §423.504(b)(4)(vi)(H). (c) Effective date of deemed status. The date the Part D sponsor is deemed to meet the applicable requirements is the later of the following: (1) The date the accreditation organization is approved by CMS. (2) The date the Part D sponsor is accredited by the accreditation organization. (d) Obligations of deemed Part D sponsors. A Part D sponsor deemed to meet Medicare requirements must— (1) Submit to surveys by CMS to validate its accreditation organization's accreditation process; and (2) Authorize its accreditation organization to release to CMS a copy of its most recent accreditation survey, together with any survey-related information that CMS may require (including corrective action plans and summaries of unmet CMS requirements). (e) Removal of deemed status. CMS removes part or all of a Part D sponsor's deemed status for any of the following reasons— (1) CMS determines, on the basis of its own investigation, that the Part D sponsor does not meet the Medicare requirements for which deemed status was granted. (2) CMS withdraws its approval of the accreditation organization that accredited the Part D sponsor. (3) The Part D sponsor fails to meet the requirements of paragraph (d) of this section. (f) Enforcement authority. CMS retains the authority to initiate enforcement action against any Part D sponsor that it determines, on the basis of its own survey or the results of an accreditation survey, no longer meets the Medicare requirements for which deemed status was granted.
Title 42: Public Health
PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
Subpart D—Cost Control and Quality Improvement Requirements
§ 423.165 Compliance deemed on the basis of accreditation.
