HHS on Thursday said it will allow a rule imposing ceiling prices on the 340B drug discount program to go into effect next year, after years of delays.
The long-postponed rule will go into effect on Jan. 1, instead of the earlier-announced July 1, 2019 date, according to a finalized rulemaking.
HHS has delayed the effective date of the ceiling price rule five times. The change will cap the prices drugmakers can charge hospitals that participate in 340B. The American Hospital Association and several other healthcare trade groups sued the agency this past fall to force it to finalize the regulations.
HHS has said in the past that it needed more time to consider additional rulemaking to replace the Obama-era regulation with one drafted by the Trump administration.
It has now changed its mind. "HHS does not believe that any further delay is necessary and is changing the effective date," the agency said.
In addition, HHS noted that the Jan. 1 start date will not interfere with any subsequent rulemaking it may release on 340B ceiling prices.
Both the American Hospital Association and 340B Health, also a hospital trade association, praised the move by HHS.
"The final rule issued today is a big step toward stopping drug companies from overcharging 340B hospitals, clinics and health centers," Maureen Testoni, interim president and CEO of 340B Health said in a statement.
Both groups urged HHS to move forward quickly with its plans to launch a ceiling price website to give providers the opportunity to check the prices they're paying. The agency said the site will be up shortly.