The 340B Program "mega-guidance" just released by the Health Resources and Services Administration (HRSA) clarifies how patients can receive deeply discounted drugs.
The 340B Program “mega-guidance” just released by the Health Resources and Services Administration (HRSA) clarifies how patients can receive deeply discounted drugs.
Amid claims of weak federal oversight and unclear language about eligibility, the 340B Drug Pricing Program has undergone many changes in the last few years.
One major change to 340B outlined in HRSA’s newly proposed guidance is that patients must meet 6 specific conditions in order to be eligible for drug discounts, which doubles the original 3.
Under this long-awaited “mega-guidance,” an individual will be considered a patient of a covered entity, and therefore eligible for drug discounts, if all of the following conditions are met:
In a statement following the release of the omnibus guidance, 340B Health said that clarifying these “gray areas” in the program is an important process, and it hopes that “safety-net health care providers will not find themselves limited in their ability to meet their mission to treat the underserved.”
Health-system leaders have expressed similar fear that a scaled-back 340B Program would hurt the very patients it was designed to benefit, including small, rural hospitals.
Pharmacy Times Health-System Edition Editor Stephen Eckel, PharmD, MHS, BCPS, FASHP, FAPhA, previously opined that while “politics will continue to place scrutiny on the current regulations…everyone needs to remember there are underserved patients among us, and…anybody who gets sick in our country should be able to receive the best care available, even if they cannot afford it.”
The guidance is open for public comment through October 27, 2015.