The trade group Pharmaceutical Research and Manufacturers of America has filed a lawsuit in federal district court to stop HHS from implementing a regulation that would allow certain healthcare providers to purchase medications used for rare diseases and conditions at discounted prices in some cases.
The Health Resources and Services Administration of HHS issued the final rule containing the regulation earlier this year to clarify how the agency will implement the 340B drug discount program orphan drug exclusion for newly eligible healthcare providers. The program makes it possible for facilities that serve a large proportion of under- or uninsured patients to purchase medications from manufacturers at reduced prices.
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 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.
Safety Net Hospitals for Pharmaceutical Access — an association of nearly 1,000 hospitals — has expressed hope the court will deny PhRMA's request for an injunction, according to a SNHPA news release. The final regulation helps rural and freestanding cancer hospitals serve the most vulnerable patients, according to SNHPA.
SNHPA released a report earlier this year to defend the 340B program after a collection of pharmaceutical and biotechnology associations released a white paper that raised concerns about the program leading to harmful consequences for patients.
More Articles on the 340B Program:
AHA, Lawmakers Defend 340B Drug Discount Program
HRSA Issues Final Rule on 340B Drug Discount Program Exclusion
340B Drug Discount Program Advocates: "This Program Works"