HHS proposes start date for 340B ceiling price after hospital suit

• HHS has proposed to begin enforcing ceiling prices for the 340B drug pricing program Jan. 1, after multiple hospital groups sued the agency for delaying enforcement five times, most recently in June. The agency had earlier set the start date for July 1 of next year.
• The ceiling prices will limit how much drug manufacturers can charge 340B hospitals for their products, one of many controversies surrounding the oft-disputed drug pricing program.
• Hospital groups and 340B advocates lauded the proposed regulation, but considering the history of HHS delays, remain cautious. CMS is accepting comments on the proposed rule through Nov. 24.

The multiple delays in enforcing ceiling prices have caused much back-and-forth among 340B hospitals which have said lack of enforcement has confused providers, leaving them unaware what their competitors pay for the same drugs, and allowed drugmakers to charge arbitrary prices for their products.

It’s one of many reasons the drug pricing program has been at the center of multiple lawsuits, congressional hearings and White House scrutiny. While safety net hospitals and their allies claim the opaque nature of the 340B drug pricing program allows drugmakers to overcharge for their products, pharmaceutical companies and pharmacy benefit managers argue that hospitals aren’t passing on the savings from the program to their patients.

This proposed regulation, and the creation of an online database that makes prices transparent, should help demystify and clear up some controversy surrounding the longstanding program.

Melinda Hatton, General Counsel to the American Hospital Association, said she is pleased that HHS proposed the ceiling start date in response to her group’s lawsuit.

“We encourage HHS to stick by this commitment and to publish the final rule in time to meet that deadline,” Hatton said in a statement.

PhRMA, the drugmaker lobby, has said in the past that it “supports regulations on ceiling price calculations and civil monetary penalties that are in line with the 340B law and eliminate needless regulatory burdens on manufacturers.” The organization has also stated support for making a 340B ceiling price database operational “as soon as possible.”

https://www.biopharmadive.com/news/hhs-proposes-start-date-for-340b-ceiling-price-after-hospital-suit/541173/