---
kind: "section"
citation: "42 C.F.R. § 447.520"
title: "42"
number: "447.520"
heading: "Federal Financial Participation (FFP): Conditions relating to physician-administered drugs."
url: "https://uscodex.org/cfr/42/447.520"
---

# §447.520. Federal Financial Participation (FFP): Conditions relating to physician-administered drugs.

- (a) **Availability of FFP.** No FFP is available for physician-administered single source drugs or the multiple source drugs identified under [paragraph (c)](#c) of this section that are covered outpatient drugs for which a State has not required the submission of claims using codes that identify the drugs sufficiently for the State to invoice a manufacturer for rebates in a manner consistent with the requirements of this section. In the case of multiple source drugs not identified under [paragraph (c)](#c), a failure to comply with the requirements of this section may result in FFP being withheld as provided under [42 CFR 430.35](/cfr/42/430.35.md). 40
  - (1) **Single source drugs.** For a covered outpatient drug that is a single source, physician-administered drug, administered on or after January 1, 2006, a State must require providers to submit claims for using National Drug Code (NDC) numbers to secure rebates and receive FFP.
  - (2) **Multiple source drugs.** For a covered outpatient drug that is a multiple source, physician-administered drug on the list published by CMS described in paragraph © of this section, administered on or after January 1, 2008, a State must require providers to submit claims using NDC numbers to secure rebates and receive FFP.
  - (3) States are required to invoice for rebates consistent with this section for multiple source physician-administered drugs that are CODs and that are not on the top 20 multiple source physician-administered drug list published under [paragraph (c)](#c) of this section, or may be subject to a withhold of FFP as provided under [42 CFR 430.35](/cfr/42/430.35.md). 41
- (b) **Required coding.** As of January 1, 2007, a State must require providers to submit claims for a covered outpatient drug that is described in paragraph [(a)(1)](#a-1) or [(2)](#a-2) of this section that is a physician-administered drug using NDC numbers. As of November 19, 2024, a State must also comply with this requirement for a covered outpatient drug that is a physician-administered drug described in [paragraph (a)(3)](#a-3) of this section.
- (c) **Top 20 multiple source physician-administered drug list.** The top 20 multiple source physician-administered drug list, identified by the Secretary as having the highest dollar volume of physician-administered drugs dispensed under the Medicaid program, will be published and may be modified from year to year to reflect changes in such volume.
- (d) **Hardship waiver.** A State that requires additional time to comply with the requirements of this section may apply to the Secretary for an extension.

## Notes

### Amendments

[89 FR 79084, Sept. 26, 2024]

### Source

Source: 81 FR 5347, Feb. 1, 2016, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 1302, and 1396r-8, and Pub. L. 111-148.

### Source

Source: 43 FR 45253, Sept. 29, 1978, unless otherwise noted.

### Amendments

[89 FR 79084, Sept. 26, 2024]