42 CFR §423.165

1. (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. (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. (2)The accreditation organization uses the standards approved by CMS for the purposes of assessing the Part D sponsor's compliance with Medicare requirements.
2. (b)Deemable requirements. The requirements relating to the following areas are deemable:
   1. (1)Access to covered drugs, as provided under §§ 423.120 and 423.124.
   2. (2)Drug utilization management programs, quality assurance measures and systems, and MTM programs as provided under § 423.153.
   3. (3)Privacy, confidentiality, and accuracy of enrollee records, as provided under § 423.136.
3. (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. (1)The date the accreditation organization is approved by CMS.
   2. (2)The date the Part D sponsor is accredited by the accreditation organization.
4. (d)Obligations of deemed Part D sponsors. A Part D sponsor deemed to meet Medicare requirements must—
   1. (1)Submit to surveys by CMS to validate its accreditation organization's accreditation process; and
   2. (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).
5. (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. (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. (2)CMS withdraws its approval of the accreditation organization that accredited the Part D sponsor.
   3. (3)The Part D sponsor fails to meet the requirements of paragraph (d) of this section.
6. (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.