Rural Pharmacy and Prescription Drugs – News

HRSA: Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: 340B Rebate Model Pilot Program Application, Implementation, and Evaluation, OMB Number 0906-0111-Extension Federal Register

Sep 12, 2025 - Notice from the Health Resources and Services Administration (HRSA) seeking comments on a proposed information collection request related to the 340B Rebate Model Pilot Program. The information collected will include the collection of 340B Rebate Model Pilot Program plans from drug manufacturers, the collection of sales data from drug manufacturers for OPA's evaluation of the pilot program and for overall 340B Program surveillance, and the collection of data submitted by covered entities to manufacturers to request a rebate. Comments are due by November 12, 2025.

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HHS: Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act of 1996 (HIPAA), National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and Modification of the Medicaid Pharmacy Subrogation Standard; Updates to Compliance and Other Related Dates Federal Register

Aug 21, 2025 - Notice of interim final rule from the U.S. Department of Health and Human Services (HHS) updating compliance and other dates in the December 13, 2024, final rule to conform with the delay of effective date changes finalized in the February 11, 2025, final rule. This rule is effective August 20, 2025. Compliance with the December 2024 rule is required by April 14, 2028.

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HRSA: 340B Program Notice: Application Process for the 340B Rebate Model Pilot Program; Correction Federal Register

Aug 7, 2025 - Notice from the Health Resources and Services Administration (HRSA) correcting the August 1, 2025, announcement of the application process for the 340B Rebate Model Pilot Program and call for comments related to the structure and application process of the program. Drug manufacturer plans for participation in the 340B Rebate Model Pilot Program should be submitted 340BPricing@hrsa.gov by September 15, 2025. The program will start January 1, 2026, and run for 1 year. Comments are due September 8, 2025.

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HRSA: Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program, OMB No. 0915-0327-Revision Federal Register

Aug 7, 2025 - Notice from the Health Resources and Services Administration (HRSA) seeking comments on an information collection request titled "Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program, OMB No. 0915-0327—Revision." HRSA requires covered entities to submit administrative information, certifying information, and attestation from appropriate grantee-level or entity-level authorizing officials and primary contacts in order to enroll and certify the eligibility of federally funded grantees and other safety net health care providers. Comments are due by October 6, 2025.

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HRSA: 340B Program Notice: Application Process for the 340B Rebate Model Pilot Program Federal Register

Aug 1, 2025 - Announcement of the application process for the 340B Rebate Model Pilot Program and call for comments related to the structure and application process of the program. This program is voluntary and aims to test a rebate model on a select group of drugs for the purpose of understanding the merits and shortcomings of the rebate model. Drug manufacturers interested in participating should email 340BPricing@hrsa.gov by September 15, 2025. The program will start January 1, 2026 and run for 1 year. Comments are due September 2, 2025.

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