340B Drug Discount Program Hits A Turning Point, But In Which Direction?
This article was originally published in RPM Report
Long-awaited “mega-guidance” sets boundaries on discount and makes big changes for HIV drugs – and could mean the beginning of the end of the scrutiny of the program. A legislative proposal floated in the context of the “21st Century Cures” bill might move things in a different direction.
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The Medicare Payment Advisory Committee (MedPAC) will be moving forward with specific recommendations to improve prescription drug provisions under Part D and Part B – but is not ready to take the lead on policy development addressing prescription drug prices overall.
House Commerce Committee members are drafting legislation to make numerous significant changes to the 340B drug discount program, including the definition of eligible patients, new reporting and auditing requirements for providers and drug manufacturers, rules for contract pharmacies – and a new user-fee program for participating health care providers.
The health care reform law dramatically expanded the number of entities eligible to purchase drugs via the federally administered 340B program, while simultaneously increasing the size of the mandatory discounts given to covered entities. Manufacturers are understandably frustrated. Rather than hope for elimination of the program, however, they may be better served working within the system to contain its impact.