HHS Announces Start Date for 340B Ceiling Price Rule

The Department of Health and Human Services (HHS) has announced it will cancel its plan to postpone imposing new ceiling prices for the 340B drug discount program. According to HHS, the program will now become effective on January 1, 2019. The agency originally announced the program would begin on July 1, 2019.

Under the ceiling price rule, drug manufacturers will have a limit on how much they can charge 340B hospitals for their products.

Until now, HHS has delayed the effective date of the ceiling price rule five times. Due to the multiple delays, many 340B hospitals have said that the lack of enforcement has confused providers and has left them unaware what their competitors pay for the same drugs. Additionally, the 340B hospitals have said that the delays have also allowed drug makers to charge arbitrary prices for their products.  

HHS originally said in the past that it needed more time to consider additional rulemaking for the ceiling price rule. However, following pressure from the 340B hospitals, it has changed its mind.

"After further consideration of the issue, HHS proposes to cease any further delay of the rule," the agency said.

The agency noted that the new date for the program launch will not interfere with any rulemaking it may release on 340B ceiling prices. Further, CMS is accepting comments through November 24 on the new effective date for the program.

—Julie Gould

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