August 7, 2009 – For the past two years, Congress has increased pressure on the Health Resources and Services Administration (HRSA) to scrap a controversial proposal to limit the definition of patients eligible for 340B-discounted medicines. Now, lawmakers are telling the federal agency to also allow health care providers more flexibility when using the 340B program.
In its annual appropriations bill for fiscal year 2010, the U.S. House of Representatives has requested that HRSA withdraw a plan to publish a revised patient definition guideline and asked the agency to allow 340B-covered entities to purchase large quantities of drug products at 340B prices to prepare for public health emergencies. The funding bill passed the House on July 24.
HRSA has relaxed its patient definition standards during large-scale public health emergencies in the past, and the House is now requesting that they also be allowed to stockpile drugs at the 340B price to prepare for such events.
While language placed in Congressional appropriations legislation is non-binding, it carries considerable influence with administrative agencies such as HRSA because the authors of the language also control funding for their departments.
The House legislation contains $1.47 million to fund the Office of Pharmacy Affairs in fiscal 2010. That is the same funding level as in 2009, but $1.5 million less than President Obama asked for. The full Senate is expected to consider its version of the fiscal 2010 appropriations bill in September.