ASCO submitted comments to U.S. House of Representatives Energy and Commerce Committee leadership in conjunction with a subcommittee hearing on the 340B Drug Pricing Program, “Opportunities to Improve the 340B Drug Pricing Program.” In writing to Committee leadership, ASCO President Monica M. Bertagnolli, MD, FACS, FASCO, underscored ASCO’s appreciation for the committee’s continued efforts “to ensure the program addresses the needs of underserved patients—particularly their ability to access cancer care.”
Congress established the 340B Drug Pricing program in 1992 to allow hospitals that care for low-income patients to obtain drugs at substantially reduced prices. The program requires drug manufacturers that participate in the Medicaid drug rebate program to extend substantial discounts on drugs administered in the outpatient setting, including oral drugs that can be distributed through contract pharmacies and physician-administered drugs such as those used to treat cancer. With dramatic growth since its inception, the 340B program has come under growing scrutiny by policymakers.
Reiterating key recommendations from its 2014 policy statement on the 340B program, the ASCO comment letter expresses the society’s support for provisions in pending legislation that would increase transparency within 340B and greater authority, resources, and staff for the Health Resources and Services Administration (HRSA) to conduct the increased oversight and enforcement the program needs.
In prior comment letters to the Centers for Medicare & Medicaid Services (CMS) and the committee, ASCO recommended HRSA collect an annual comprehensive accounting of the amount of 340B savings covered entities receive under the program and the percentage of those savings that are reinvested into caring for the uninsured, underinsured, and Medicaid patients. Such transparency is necessary to ensure the program remains true to its original intent.
ASCO’s comments also urge Congress to discontinue use of the Disproportionate Share Hospital (DSH) adjustment as a determining measure for program eligibility and urges Congress to create a metric that appropriately measures levels of charity care for program eligibility. Furthermore, ASCO urges Congress to consider the impact of 340B on oncology practices and to work with HRSA to establish 340B eligibility for all oncology practices demonstrating a commitment to serving low-income and underserved patients.
ASCO agrees that the 340B program needs reform, writes Dr. Bertagnolli, and “…urges Congress to keep the impact of the 340B program on cancer patients and access to cancer care at the forefront… .”