HRSA Updates 340B Drug Discounts Enrollment Process for Feedback
Published Date: 1/8/2026
Notice
Summary
The Health Resources and Services Administration (HRSA) is updating how hospitals and clinics sign up and renew their participation in the 340B Drug Pricing Program, which helps them get medicines at lower prices. They’re asking for public feedback by February 9, 2026, before finalizing these changes. This update aims to keep the process smooth and fair, with no big cost changes expected for the entities involved.
Analyzed Economic Effects
7 provisions identified: 5 benefits, 2 costs, 0 mixed.
Estimated Total Annual Administrative Burden
HRSA estimates the total annualized burden for this information collection is 74,248 hours across 46,183 respondents and 139,251 total responses. Specific items include 48,136 hours for contracted pharmacy registrations and 8,772 hours for hospital annual recertifications, among others.
New STD/TB Documentation Requirement
If you are an STD or TB grantee enrolling or recertifying in the 340B Program, you must provide supporting documentation such as a federal grant notice of award (grantor, grant number, period of funding, recipient) and, for subgrantees, an executed subrecipient agreement. HRSA says this will slightly increase the administrative burden (average burden for some collections increased from 1.0 to 1.25 hours).
Shipping Address Clarification
HRSA added clearer shipping-address questions in the 340B registration system to identify whether an address is a pharmacy, a health care delivery site, or another receiving location. HRSA says this should make reviews more efficient and will not significantly change the burden on covered entities.
Family Planning Time-Period Field Added
Family Planning (Title X) covered entities must now report the time period when assistance was received during 340B registration and recertification. HRSA says this is a minor addition and will not significantly increase burden because the time period is readily available.
Tribal Agreement Number Collection
Urban Indian and Tribal Contract/Compact (FQHC628/FQHC638) covered entities must provide their Tribal Agreement number in OPAIS during registration and recertification to help verify eligibility. HRSA says this will not significantly increase burden.
Hospital Form Language Clarifications
HRSA revised hospital registration fields (e.g., changing 'File Date' to 'Date/Time Prepared' and 'Medicare Provider Number' to 'CMS Certification Number'), clarified Worksheet S submission (signed, dated, encrypted copy), and trial balance instructions to reduce confusion. HRSA says these changes do not change burden on hospitals.
No Changes for Contract Pharmacies, PPA, Pricing
HRSA states there are no changes to Contract Pharmacy Certification, the Pharmaceutical Pricing Agreement (PPA) and addendum, or Pricing Data Submission/Validation/Dissemination from prior submissions. HRSA says there is no change in burden on manufacturers or contract pharmacies.
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