In This Issue:

- 340B Drug Discount Program Guidance Nearing Finish Line

- Implementation of the Affordable Care Act

- Federal Regulatory Initiatives

- Congressional Initiatives

- Other Health Care News

- Upcoming Congressional Hearings

- Excerpt from 340B Drug Discount Program Guidance Nearing Finish Line:

On May 6th, the Health Resources and Services Administration (HRSA) formally submitted highly-anticipated guidance on the 340B drug program to the White House Office of Management and Budget (OMB) for final review. The guidance entitled, “340B Program Omnibus Guidelines,” also commonly referred to as the “mega-rule” follows a series of legal battles last year that called into question HRSA’s authority over certain aspects of the 340B program.

Stakeholders are anxiously awaiting HRSA guidance on a variety of 340B issues ranging from contract pharmacy compliance requirements to the definition of a qualifying “patient” to the possible extension of discounts to off-site facilities of covered entities. Depending on the length of OMB review, most experts believe that the guidelines could be published as early as this summer. The Obama Administration has indicated that there would be a normal public comment period.