The Health Resources and Services Administration of HHS has issued a final rule to clarify how the agency will implement the 340B drug discount program orphan drug exclusion for newly eligible healthcare providers.
The final rule allows healthcare providers who are newly eligible for the program under the Patient Protection and Affordable Care Act to buy outpatient orphan drugs — pharmaceuticals used for a rare disease or condition designated by the Federal Food, Drug, and Cosmetic Act — at 340B prices as long as the medications are used to treat common conditions and not the rare diseases that prompted the orphan drug designation.
The 340B program allows nonprofit hospitals, community health centers, hemophilia treatment centers, HIV/AIDS clinics and other similar facilities that serve a large proportion of under- or uninsured patients to purchase medications from manufacturers at reduced prices.
The PPACA expands the program to include providers such as critical access hospitals, freestanding non-prospective payment system cancer hospitals, sole community hospitals, certain non-PPS children's hospitals and rural referral centers with disproportionate share adjustments equal to or greater than 8 percent.
More Articles on the 340B Drug Discount Program:
340B Drug Discount Program Advocates: "This Program Works"
Safety Net Hospital Group Defends Members' 340B Program Operations
Sen. Chuck Grassley Probes Georgia Health System's Use of 340B Drug Program