1. (a) Availability of FFP. No FFP is available for physician-administered single source drugs or the multiple source drugs identified under paragraph (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), a failure to comply with the requirements of this section may result in FFP being withheld as provided under 42 CFR 430.35. ⁴⁰

   1. (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. (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. (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) of this section, or may be subject to a withhold of FFP as provided under 42 CFR 430.35. ⁴¹
2. (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) or (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) of this section.
3. (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.
4. (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.

⁴⁰ https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-C/part-430.

⁴¹ Ibid.

[89 FR 79084, Sept. 26, 2024]