§423.165. Compliance deemed on the basis of accreditation.
42 C.F.R. § 423.165
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—
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
The accreditation organization uses the standards approved by CMS for the purposes of assessing the Part D sponsor's compliance with Medicare requirements.
Deemable requirements. The requirements relating to the following areas are deemable:
Drug utilization management programs, quality assurance measures and systems, and MTM programs as provided under § 423.153.
Privacy, confidentiality, and accuracy of enrollee records, as provided under § 423.136.
Effective date of deemed status. The date the Part D sponsor is deemed to meet the applicable requirements is the later of the following:
The date the accreditation organization is approved by CMS.
The date the Part D sponsor is accredited by the accreditation organization.
Obligations of deemed Part D sponsors. A Part D sponsor deemed to meet Medicare requirements must—
Submit to surveys by CMS to validate its accreditation organization's accreditation process; and
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).
Removal of deemed status. CMS removes part or all of a Part D sponsor's deemed status for any of the following reasons—
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.
CMS withdraws its approval of the accreditation organization that accredited the Part D sponsor.
The Part D sponsor fails to meet the requirements of paragraph (d) of this section.
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.
Notes, amendments, and revision history
Amendments
[70 FR 4525, Jan. 28, 2005, as amended at 75 FR 19818, Apr. 15, 2010; 89 FR 30835, Apr. 23, 2024]
Authority
Authority: 42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh.
Source
Source: 70 FR 4525, Jan. 28, 2005, unless otherwise noted.
Amendments
[70 FR 4525, Jan. 28, 2005, as amended at 75 FR 19818, Apr. 15, 2010; 89 FR 30835, Apr. 23, 2024]