H.R. 5256: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act

The 340B ACCESS Act is a legislative proposal that focuses on updating and reforming the 340B drug pricing program. The key objectives of the bill are to enhance oversight of the program, clarify eligibility criteria for patients and entities, and regulate contract pharmacies. The aim is to make medications more affordable while ensuring that the operations of the program are transparent and accountable.

Key Provisions

• Pharmacy Requirements: The bill sets forth specific requirements for pharmacies related to licensing and location. These criteria are designed to ensure that pharmacies work appropriately with covered entities under the 340B program.
• Sliding Fee Scale: A sliding fee scale will be implemented to help maintain drug affordability for patients receiving treatment through the 340B program.
• Reporting and Compliance: Covered entities will be required to disclose any noncompliant drug purchases. This includes conducting audits on their operations and being subject to civil penalties for failing to comply with the program's guidelines.
• Charity Care Requirements: To participate in the 340B program, covered entities must also meet annual requirements related to charity care, ensuring that they provide care to low-income patients.
• Enforcement Mechanisms: The bill includes provisions for auditing contracts, penalties for fraudulent claims, and the establishment of a claims data clearinghouse to promote compliance and equity in drug pricing.

Amendments to the Social Security Act

The legislation will amend the Social Security Act to ensure that the same regulations that apply to health plans and issuers also apply to certain contract sponsors and pharmacy benefit managers. This is intended to create a more uniform regulatory approach across the board.

Implementation Timeline

Once the bill is enacted, the provisions outlined will take effect one year later, allowing time for the affected parties to prepare for compliance with the new regulations.

Relevant Companies

• PFE - Pfizer: Likely to be affected as their pricing strategies may need to adjust in response to increased oversight and reporting requirements under the 340B program.
• JNJ - Johnson & Johnson: As a major pharmaceutical company, they may see changes in their partnerships and sales strategies related to 340B covered entities.
• ABBV - AbbVie: Changes to the 340B program could impact how they price and distribute their medications through contract pharmacies.