Summary#
This bill updates rules for the 340B drug discount program. It defines who counts as a "patient" and who is a "prescribing provider." It sets new rules for contract pharmacies, including registration, standard written agreements, and public reporting. The bill creates a national data clearinghouse to collect claims-level data to prevent duplicate discounts and drug diversion, and it requires audits by the Department of Health and Human Services (HHS) and independent auditors. It adds detailed eligibility rules and a "community need" standard for hospital child sites. The bill requires covered entities to publish and apply financial assistance policies, places limits on certain hospital debt-collection practices, and requires many new reports and studies by HHS, the Inspector General, and the Government Accountability Office (GAO). It also establishes a user-fee program to fund oversight and authorizes specific annual appropriations for audits and program work.
What it means for you#
- Patients: Covered entities must have and show financial assistance policies and provide notices at point of care. Certain hospitals are restricted from selling patient debt or reporting it to credit bureaus; limits on suing to collect medical debt apply to specified hospitals.
- Community health centers and hospitals: New patient and prescribing-provider definitions, child-site rules, and community-need tests affect which sites can use 340B discounts. Covered entities must register sites and contract pharmacy agreements and keep records for audits.
- Contract pharmacies and third-party administrators: Must register, follow standard contract terms, submit data to covered entities and the clearinghouse, and meet retention and audit requirements.
- Manufacturers and payers: Manufacturers must offer 340B drugs at the ceiling price and allow delivery to contract pharmacies; clearinghouse access gives manufacturers claims-level data for program integrity purposes.
- Health system oversight: HHS (HRSA and CMS) will run new audits, publish data reported by covered entities, and oversee a clearinghouse for claims-level data.
Expenses#
- The bill authorizes user fees starting in fiscal year 2027; the general formula is 0.1 percent of the dollar amount paid by a covered entity for 340B drugs in the prior year (details to be set by rule).
- It authorizes $3,000,000 per year for fiscal years 2027 through 2031 for audits and oversight, and $9,000,000 per year for fiscal years 2028 through 2031 for implementation activities.
- The bill requires creation and contracting for a third-party data clearinghouse; specific contract costs are not listed in the bill text.
- No publicly available information on total net fiscal impact beyond the amounts and fee formula specified in the bill text.
Proponents' View#
The bill is drafted "to strengthen the 340B drug discount program." It includes measures aimed at improving program integrity and transparency: clearer patient and prescriber definitions, stronger oversight of contract pharmacies and child sites, a data clearinghouse to detect duplicate discounts and diversion, mandatory reporting by covered entities, expanded audits, and protections intended to improve patient affordability and limit certain hospital debt-collection practices.
Opponents' View#
No publicly available information.