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Friends of 340B Bill Draft: A Step in the Right Direction

In a move to fortify the 340B program, the Bipartisan 340B Senate Working Group has unveiled the SUSTAIN 340B Act. This all-encompassing legislative proposal addresses critical facets such as contract pharmacies, patient definition, child sites, transparency, program integrity, duplicate discounts, equitable treatment, and the introduction of a user fee program. This blog post delves into key sections of the bill, exploring their potential impact on the 340B program.


SUSTAIN 340B Act Discussion Draft_
.pdf
Download PDF • 102KB
340B Letter to Stakeholders 020224
.pdf
Download PDF • 244KB
340B Discussion Draft Explanatory Document and Subsequent RFI
.pdf
Download PDF • 131KB

Summary of Key Sections:

1. Short Title and Sense of Congress

  • Short Title: "Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act" (SUSTAIN 340B Act).

  • Sense of Congress: Affirms the 340B program's mission to assist safety net providers serving low-income and underserved patients.

2. Contract Pharmacy

  • Objective: Provide clarity on contract pharmacy arrangements.

  • Focus Areas: Balancing patient access, program integrity, and accountability, with stakeholder input crucial.

3. Patient Definition

  • Objective: Define "patient" in response to recent litigation.

  • Considerations: Stakeholder feedback sought on factors like meaningful patient relationships and time limitations.

4. Child Sites

  • Objective: Clarify establishment and use of child sites.

  • Guidelines: Proposes using Medicare provider-based guidelines, emphasizing clinical and financial integration.

5. Transparency

  • Objective: Enhance transparency by requiring detailed reporting from covered entities.

  • Information: Report includes data on drug dispensation, charity care costs, patient demographics, etc.

6. Enhancing Program Integrity

  • Objective: Empower Secretary to conduct audits on covered entities, child sites, pharmacies, and manufacturers.

  • Compliance: Focus on ensuring adherence to statute, financial assistance transparency, and accountability.

7. Preventing Duplicate Discounts

  • Objective: Establish a national clearinghouse to prevent duplicate discounts.

  • Participation: Covered entities must engage in data exchange, with regulations addressing duplicate discounts.

8. Ensuring Equitable Treatment

  • Objective: Address concerns about health plans and PBMs.

  • Prohibitions: Prevent discriminatory actions against covered entities and contract pharmacies.

9. User Fee Program

  • Objective: Introduce a user fee program to supplement HRSA resources.

  • Calculation: Fee based on program savings, ensuring it complements congressional appropriations.

Stakeholder Communication - February 2, 2024


"We request stakeholders submit any comments and edits to the discussion draft in writing no later than April 1, 2024. Responses may be submitted to Bipartisan340BRFI@email.senate.gov."

In a recent communication addressed to 340B stakeholders, the group emphasizes their long-standing support for the 340B program, acknowledging its critical benefit to eligible healthcare providers. They recognize concerns about ambiguity and the need for transparency in ensuring the program's original intent to serve eligible patients. Key points from the communication include:

  1. Program Benefits:

  • "We believe the program provides a critical benefit to eligible health care providers."

  • "Enables them to stretch federal resources to provide healthcare services for the patients they serve."

  1. Stakeholder Engagement:

  • "Began a process to seek information from stakeholders on bipartisan policy solutions."

  • "Issued a Request for Information on June 16th, 2023, receiving over 250 responses."

  • "Spent months reviewing responses and holding additional meetings with stakeholders."

  1. Areas of Concern:

  • Addressing concerns raised by stakeholders, including:

  • "HRSA’s authorities and resources."

  • "Contract pharmacy arrangements."

  • "Role of PBMs in the program."

  • "Duplicate discounts."

  • "Promotion of transparency and program integrity."

  1. Legislation Proposal:

  • "Believe it is necessary to pass legislation in the 118th Congress."

  • Aims for "clarity, transparency, and accountability in the 340B program."

  • Release of a "legislative discussion draft" to address areas of concern and achieve program goals.

  1. Additional Areas of Inquiry:

  • Seeking more information on:

  • "Patient definition."

  • "Child sites."

  • "Contract pharmacy arrangements."

  1. Request for Stakeholder Input:

  1. Confidentiality Assurance:

  • "Intent is to continue to keep these responses internal."

  • Responses will not be posted publicly.

The communication outlines their dedication to gathering stakeholder input, addressing concerns, and taking legislative action to enhance the 340B program's effectiveness.




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