Section 423.165 - [Effective 6/3/2024] Compliance deemed on the basis of accreditation(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 MTM programs as provided under § 423.153 .(3) Privacy, confidentiality, and accuracy of enrollee records, as provided under § 423.136 .(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)Authority. Nothing in this section limits CMS' authority under subparts K and O of this part, including, but not limited to the ability to impose intermediate sanctions, civil money penalties, and terminate a contract with a Part D plan sponsor.70 FR 4525, Jan. 28, 2005, as amended at 75 FR 19818, Apr. 15, 2010