---
kind: "section"
citation: "42 C.F.R. § 423.1"
title: "42"
number: "423.1"
heading: "Basis and scope."
url: "https://uscodex.org/cfr/42/423.1"
---

# §423.1. Basis and scope.

- (a) **Basis.**
  - (1) **This part is based on the indicated provisions of the following sections of the Social Security Act—** 1106. Disclosure of Information in Possession of Agency.

    1128J(d). Reporting and Returning of Overpayments.

    1860D-1. Eligibility, enrollment, and information.

    1860D-2. Prescription drug benefits.

    1860D-3. Access to a choice of qualified prescription drug coverage.

    1860D-4. Beneficiary protections for qualified prescription drug coverage.

    1860D-11. PDP regions; submission of bids; plan approval.

    1860D-12. Requirements for and contracts with prescription drug plan (PDP) sponsors.

    1860D-13. Premiums; late enrollment penalty.

    1860D-14. Premium and cost-sharing subsidies for low-income individuals.

    1860D-14A. Medicare coverage gap discount program.

    1860D-14C. Manufacturer Discount Program.

    1860D-15. Subsidies for Part D eligible individuals for qualified prescription drug coverage.

    1860D-16. Medicare Prescription Drug Account in the Federal Supplementary Medical Insurance Trust Fund.

    1860D-21. Application to Medicare Advantage program and related managed care programs.

    1860D-22. Special rules for Employer-Sponsored Programs

    1860D-23. State pharmaceutical assistance programs.

    1860D-24. Coordination requirements for plans providing prescription drug coverage.

    1860D-31. Medicare prescription drug discount card and transitional assistance program.

    1860D-41. Definitions; treatment of references to provisions in Part C.

    1860D-42. Miscellaneous provisions.

    1860D-43. Condition for coverage of drugs under this part.

  - (2) The following specific sections of the Medicare Modernization Act also address the prescription drug benefit program:

    [Sec. 102](/cfr/42/102.md) Medicare Advantage conforming amendments.

    [Sec. 103](/cfr/42/103.md) Medicaid amendments.

    [Sec. 104](/cfr/42/104.md) Medigap.

    [Sec. 109](/cfr/42/109.md) Expanding the work of Medicare Quality Improvement Organizations to include Parts C and D.

  - (3) Section 1611 of [Title 8](/cfr/8.md) of the United States Code regarding individuals who are not lawfully present and ineligible for Federal public benefits.
- (b) **Scope.** This part establishes standards for beneficiary eligibility, access, benefits, protections, and low-income subsidies in Part D, as well as establishes standards and sets forth requirements, limitations, procedures and payments for organizations participating in the Voluntary Medicare Prescription Drug Program.

## Notes

### Amendments

[70 FR 4525, Jan. 28, 2005, as amended at 73 FR 30683, May 28, 2008; 79 FR 29962, May 23, 2014; 80 FR 7962, Feb. 12, 2015; 91 FR 17583, Apr. 6, 2026]

### 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 73 FR 30683, May 28, 2008; 79 FR 29962, May 23, 2014; 80 FR 7962, Feb. 12, 2015; 91 FR 17583, Apr. 6, 2026]