2016 HHS Budget


340B HHS Budget 2016The 2016 Department of Health and Human Services (HHS) budget has been submitted to President Obama. HHS invests in scientific research, health care, disease prevention, early education, social services, and children’s well-being, to support healthier families, stronger communities, economic opportunity, and a thriving America. HRSA (and the 340B Program) fall into this category.

340B Drug Pricing Program: The Budget provides $17 million in budget authority for the 340B Drug Pricing Program, which represents an increase of $7 million above FY 2015. In addition, it proposes a new user fee totaling $7.5 million as a long-term financing strategy to support the program’s activities. These fees represent 0.1 percent of each purchase of 340B drugs from entities participating in the 340B Program to pay for the operating costs of the program. These fees will be collected by the Secretary based on sales data that shall be submitted by drug manufacturers and shall be credited to this account, to remain available until expended.

In recent years, HRSA has significantly increased its commitment to program integrity and compliance (covered entities should plan on being audited very soon!). As additional covered entities and associated sites join the 340B Program, HRSA has nearly doubled its program audits, instituted annual recertification for all entities, and increased its proactive education and technical assistance. Nearly 26,000 covered entities across the country currently participate in the 340B Program. It is estimated that covered entities participating in the 340B Program spend an estimated $7.5 billion on covered outpatient drugs.

See the full articles here:
Fiscal Year 2016 – Budget In Brief
Budget Justifications 2016

As always, please let us know if you have any questions or need some help with your 340B Program. Also, if you are interested in having your covered entity site receive a full independent audit of your 340B operations, come see us at Turnkey Pharmacy Solutions.

Richard Iverson, PMP