WASHINGTON — Congress is working to protect a program that ensures rural hospitals, clinics and other medical facilities that care for underserved communities can afford the drugs they prescribe.
Congresswoman Elise M. Stefanik, R-Schuylerville, added her name to the bipartisan PROTECT Act, a piece of legislation that reaffirms and tightens the rules surrounding the 340B drug pricing program.
A federal program, 340B requires pharmaceutical manufacturers to provide their products at a discounted rate to certain qualified health care providers, including many rural hospitals and clinics.
In May, the federal Health Resources and Services Administration, which oversees the 340B program, said six companies — AstraZeneca, Lilly, Novartis, Novo Nordisk, Sanofi and United Therapeutics — have been violating the rules of the program.
According to the HRSA, these companies were not offering their drugs at the required discounted prices to qualified health care organizations that didn’t have their own in-house pharmacy. Those health care groups were working with contract pharmacies, third-party companies that entered into an agreement with the 340B-qualified health care facility to provide pharmacy services.
The pharmaceutical companies would either charge the full price for the medication or decline to provide the medication at all. The HRSA sent a letter on May 17 calling on the pharmaceutical companies to resume sales to contract pharmacies. Three companies refused, and two others have sued the Department of Health and Human Services.
The legislation co-sponsored by Rep. Stefanik would codify into law new regulations surrounding the 340B program, specifying that no pharmaceutical company or pharmacy benefit manager may stop sales to 340B-qualified pharmacies or their contracted pharmacies. They will also be barred from establishing any requirements, exclusions, reimbursement terms or other limitations on 340B-qualified providers that are not set for regular providers as well.
In a statement announcing her support for the PROTECT Act, Rep. Stefanik said it’s an important program that ensures patients across the north country can retain access to affordable medicine.
“Rural communities in the north country have been well-served by this important program that provides access to discounted drugs and lifesaving services,” she said. “But current threats to this program are making it increasingly difficult for north country hospitals to administer lifesaving drugs at a discounted price to patients in need. The 340B program is essential to providing access to health care for north country communities and I am proud to continue to advocate for it.”