340B "Mega-Guidance": More Conditions for Drug Discounts

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:

• The individual receives a health care service at a facility or clinic site that is registered for the 340B Program and listed on the public 340B database.
• The individual receives a health care service provided by a covered entity provider who is either employed by the covered entity or is an independent contractor for the covered entity, such that the covered entity may bill for services on behalf of the provider.
• The individual receives a drug that is ordered or prescribed by the covered entity provider as a result of the service described above.
• The individual’s health care is consistent with the scope of the federal grant, project, designation, or contract.
• The individual’s drug is ordered or prescribed pursuant to a health care service that is classified as outpatient.
• The individual’s patient records are accessible to the covered entity and demonstrate that the covered entity is responsible for care.

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.