Response Divided on New 340B Legislation

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AAFCPAs would like to make clients aware that legislation designed to overhaul the 340B program was recently introduced. This legislation, previously coined the 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act), seeks to establish new transparency and oversight requirements and capture policy principles agreed upon in the Alliance to Save America’s 340B Program (ASAP 340B).

This new legislation would codify a 340B patient definition and establish patient affordability requirements to ensure qualifying low-income and uninsured patients pay reduced out-of-pocket costs for medications. It would also tighten hospital eligibility requirements and recognize contract pharmacies in statute. Additionally, this legislation would restrict the pharmacy benefit managers’ (PBMs) role and that of the for-profit entity (including contract pharmacies) and establish new child site eligibility standards.

Response to this new legislation has been divided. In favor is Rep. Larry Bucshon, M.D., Vice Chair of the Energy & Commerce Health Subcommittee, who sees this as a means to restore program integrity and uphold its original mission of providing affordable medications to those who need it most. Likewise, the National Association of Community Health Centers (NACHC) called the bill a milestone in its efforts to protect 340B and unite stakeholders around a comprehensive solution.

Advocates for Community Health (ACH), however, expressed opposition to this legislation stating it significantly reduces a health centers’ ability to leverage 340B on their patients’ behalf and favors the pharmaceutical industry’s preferred 340B cuts. ACH is instead urging Congress to incorporate principles drafted in its 340C legislation proposal. Opponents to the bill view this as a means for further cutting 340B eligibility and adding to restrictions already imposed by drug companies, thus further harming patient access in order to bolster the profit margins of pharmaceutical companies.

AAFCPAs will continue to monitor this legislation and provide updates as appropriate.

How We Help

AAFCPAs has provided 340B audit and consultation services since the program’s inception in 1992. This includes regular 340B compliance training for clients and membership associations, assistance with 340B program integrity, maintenance of program compliance documentation, and assistance with preparations for Office of Pharmacy Affairs (OPA) audits. Our services have helped clients reduce the risk of penalties and program disqualification, maintain program eligibility, optimize savings, improve strategic decisions, navigate regulations more effectively, implement improvements that internal teams might overlook, and reassure stakeholders of their commitment to excellence.

If you have questions, please contact Courtney McFarland, CPA, MSA, 340B Apexus Certified Expert™ at 774.512.4051 or cmcfarland@nullaafcpa.com, Pauline Legor, CPA, MBA, Director, Healthcare Practice at 774.512.4158 or plegor@nullaafcpa.com—or your AAFCPAs Partner.