{"data":{"id":"us/42-cfr-423.165","jurisdiction":"us","citation":"42 CFR 423.165","heading":"Compliance deemed on the basis of accreditation.","body":"(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—\n(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\n(2) The accreditation organization uses the standards approved by CMS for the purposes of assessing the Part D sponsor's compliance with Medicare requirements.\n(b) Deemable requirements. The requirements relating to the following areas are deemable:\n(1) Access to covered drugs, as provided under §§ 423.120 and 423.124.\n(2) Drug utilization management programs, quality assurance measures and systems, and MTM programs as provided under § 423.153.\n(3) Privacy, confidentiality, and accuracy of enrollee records, as provided under § 423.136.\n(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:\n(1) The date the accreditation organization is approved by CMS.\n(2) The date the Part D sponsor is accredited by the accreditation organization.\n(d) Obligations of deemed Part D sponsors. A Part D sponsor deemed to meet Medicare requirements must—\n(1) Submit to surveys by CMS to validate its accreditation organization's accreditation process; and\n(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).\n(e) Removal of deemed status. CMS removes part or all of a Part D sponsor's deemed status for any of the following reasons—\n(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.\n(2) CMS withdraws its approval of the accreditation organization that accredited the Part D sponsor.\n(3) The Part D sponsor fails to meet the requirements of paragraph (d) of this section.\n(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.","path":["Title 42—Public Health","CHAPTER IV—CENTERS FOR MEDICARE \u0026 MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER B—MEDICARE PROGRAM","PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT","Subpart D—Cost Control and Quality Improvement Requirements"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-42.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:26:11Z","sha256":"7dcc786d87cdeafa7a6b3087ab53363819634c68974c51cb6a7ea53435e50ba0","source_id":"us-cfr","stale":true,"prev":"us/42-cfr-423.162","next":"us/42-cfr-423.168"},"notice":"GroundRules: Original legal text. Not legal advice."}