publication date: Sep. 11, 2015

HRSA Publishes Long-Awaited 340B Mega-Rule 


The Health Resources and Services Administration issued the long-awaited “mega-rule” intended to define who qualifies for deep discounts on drug prices under the federal 340B program.

Established in 1992 to benefit hospitals and clinics that serve low-income and uninsured patients, the 340B Drug Pricing Program has expanded exponentially in recent years.

Hospitals, clinics and cancer centers rely on it to buy drugs at discounts of as much as 50 percent—and then collect reimbursements that don’t reflect the discount. About a third of the country’s non-federal hospitals qualify for the program: as of Jan. 1, 2015, there were 11,530 registered and covered entities.

Many key players in oncology have been questioning the program’s expansion and its eligibility criteria. According to critics, the program is poorly defined, and is increasingly abused by entities that don’t need help from the government.

The 90-page 340B Program Omnibus Guidance published Aug. 28 provides stricter definitions for which patients and entities should be covered—a move that 340B advocates say would limit patient access to drug discounts.

The omnibus is open for public comment through Oct. 27.

“It has been a long time coming,” 340B Health, a Washington, D.C. trade association, said in a statement. “There are gray areas in the program and we look forward to having more clarity.”

Formerly called Safety Net Hospitals for Pharmaceutical Access, 340B Health represents over 340B-enrolled 1,000 hospitals.

Continue reading 41-33 HRSA Publishes Long-Awaited 340B Mega-Rule
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