---
kind: "section"
citation: "42 C.F.R. § 423.165"
title: "42"
number: "423.165"
heading: "Compliance deemed on the basis of accreditation."
url: "https://uscodex.org/cfr/42/423.165"
---

# §423.165. 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)](#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)](#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](/cfr/42/423.120.md) and [423.124](/cfr/42/423.124.md).
  - (2) Drug utilization management programs, quality assurance measures and systems, and MTM programs as provided under [§ 423.153](/cfr/42/423.153.md).
  - (3) Privacy, confidentiality, and accuracy of enrollee records, as provided under [§ 423.136](/cfr/42/423.136.md).
- (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.

## Notes

### 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]