April 20, 2017—A coalition of hospitals and other safety-net healthcare providers in a federal drug discount program is urging the government to implement a long-overdue regulation to police the pharmaceutical industry.
The 340B drug discount program provides healthcare providers with relief from high drug prices. They rely on the savings to fund critical programs for their low-income, uninsured, and underinsured patient populations. In 2010, Congress directed the U.S. Department of Health and Human Services to issue 340B program regulations for determining ceiling prices and imposing civil monetary penalties on manufacturers that “knowingly and intentionally” break the ceilings.
After three rounds of notice and comment, HHS published a final rule on Jan. 5, 2017, with a March 6 effective date and enforcement to begin on April 1. In early March, pursuant to the Trump administration’s regulatory freeze memo to federal agencies, HHS delayed the rule to May 22 and requested comments on a possible additional delay until Oct. 1.
Further delay of the 340B regulation “will harm 340B covered entities and the patients that they serve,” groups in the 340B Coalition said in joint comments to HHS. 340B Health, the association of hospitals in the drug discount program, is a coalition member. Delaying the regulation’s implementation also is contrary to the Administrative Procedure Act and the 340B statute, the groups added.
“The 340B program provides crucial relief from high drug prices to providers that rely on the savings to fund critical programs for their low-income, uninsured and underinsured patient populations,” the coalition observed. “Manufacturer overcharges have long plagued the 340B program.”