340B Drug Pricing Program; Administrative Dispute Resolution Regulation

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services 42 CFR Part 10 [Docket No. 2021-0004] RIN 0906-AB28 ( printed page 28643) AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Final rule. SUMMARY: The Health Resources and Services Administration administers section 340B of the Public Health Service (PHS) Act, which is referred to as the “340B Drug Pricing Program” or the “340B Program.” This final rule will apply to all drug manufacturers and covered entities that participate in the 340B Program. The final rule sets forth the requirements and procedures for the 340B Program's administrative dispute resolution (ADR) process. This final rule revises the 340B administrative dispute resolution process set forth in the Code of Federal Regulations. DATES: This final rule is effective June 18, 2024. FOR FURTHER INFORMATION CONTACT: Michelle Herzog, Deputy Director, Office of Pharmacy Affairs, HRSA, 5600 Fishers Lane, Mail Stop 08W12, Rockville, MD 20857; email: 340badr@hrsa.gov ; telephone: 301-594-4353. SUPPLEMENTARY INFORMATION: I. Background Section 340B of the PHS Act entitled “Limitation on Prices of Drugs Purchased by Covered Entities,” was created under section 602 of Public Law 102-585, the “Veterans Health Care Act of 1992,” and codified at 42 U.S.C. 256b . The 340B Program is intended to enable covered entities “to stretch scarce Federal resources as far as possible,…