---
kind: "section"
citation: "42 C.F.R. § 423.512"
title: "42"
number: "423.512"
heading: "Minimum enrollment requirements."
url: "https://uscodex.org/cfr/42/423.512"
---

# §423.512. Minimum enrollment requirements.

- (a) **Basic rule.** Except as provided in [paragraph (b)](#b) of this section, CMS does not enter into a contract under this subpart unless the organization meets the following minimum enrollment requirement:
  - (1) At least 5,000 individuals are enrolled for the purpose of receiving prescription drug benefits from the organization; or
  - (2) At least 1,500 individuals are enrolled for purposes of receiving prescription drug benefits from the organization and the organization primarily serves individuals residing outside of urbanized areas as defined in [§ 412.62(f)](/cfr/42/412.62.md?p=f) of this chapter;
  - (3) Except as provided for in [paragraph (b)](#b) of this section, a Part D plan sponsor must maintain a minimum enrollment as defined in paragraphs [(a)(1)](#a-1) and [(a)(2)](#a-2) of this section for the duration of its contract.
- (b) **Minimum enrollment waiver.** CMS waives the requirement of paragraphs [(a)(1)](#a-1) and [(a)(2)](#a-2) of this section during the first contract year for a sponsor in a region.

## Notes

### 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.