Hemophilia treatment centers (HTCs) participating in the 340B Drug Pricing Program have been busy over the past several months analyzing and responding to proposed guidance issued by the Department of Health and Human Services’ Health Resources and Services Administration (HRSA). The guidance proposes major changes to how federal grantees, such as the HTCs, and hospitals will participate in the drug discount program. The proposed guidance was released in late August and was open for public comment through October 27, 2015. Of greatest concern to the HTCs were some of the proposed changes related to the definition of an eligible patient, the audit requirements, and issues related to how federal grantees and sub-grantees access and are listed as participants in the program. The guidance is not likely to be finalized until next year and an implementation date of its provisions is uncertain.
As background, the Veterans Health Care Act of 1992 designated federally-funded HTCs as covered entities eligible to participate in the 340B Drug Pricing Program. HTCs were included as covered entities to stretch their federal grant funding to provide comprehensive services to all patients served by the center. Before the passage of the Affordable Care Act, access to discounted drugs also prevented patients from exceeding their insurance plans’ lifetime and annual limits. Today, approximately 100 of the 140 HTCs have elected to participate in the 340B program. As a condition of their federal grant, HTCs must invest all revenues from the 340B program back into patient services, care coordination, research and other programs that directly benefit patients.
NHF issued a policy statement this year in support of HTC participation in the 340B Program. In addition, NHF submitted a comment letter on the proposed guidance in support of many of the concerns raised by the HTCs and The Hemophilia Alliance. NHF believes that HTCs with 340B drug programs are an important option that should be available to all patients, regardless of their health insurance coverage.
Whether HRSA will revise its proposed guidance recognizing the concerns raised by the HTCs is uncertain. There is also the possibility that Congress will act and changes will be made to the 340B Program through legislation. The outcome is uncertain at this point, but it will likely be an issue for HTCs and the bleeding disorders community in 2016. NHF’s public policy team will keep you informed of the outcome of any changes to the 340B Drug Pricing Program and how they might affect you and your family.
