HHS seeks 1-year delay on 340B price regulation: 4 things to know

HHS released a proposed rule May 4 to delay a regulation that prevents drug companies from overcharging hospitals under the 340B drug discount program.

Here are four things to know.

1. The rule would not only set new drug price ceilings for the 340B program, but also grant HHS authority to fine drugmakers for intentionally charging hospitals above the established price limits. At present, the rule is set to take effect July 1, but the proposal would delay the regulation for another year.

2. HHS' move to postpone the rule stems from an executive order President Donald Trump issued Jan. 20, 2017, instructing all federal offices to delay the implementation of any ACA requirements that may create fiscal or regulatory burdens.

"HHS believes that the proposed delay would allow necessary time to consider more fully the substantial questions of fact, law, and policy identified by the Department during its review of the rule," the agency wrote in the proposed rule. "Requiring manufacturers to make targeted and potentially co 4 recent RCM tipsstly changes to pricing systems and business procedures to comply with a rule that is under further consideration would be disruptive."

3. Tom Nickels, American Hospital Association executive vice president of government relations and public policy, opposed the proposal to once again delay the regulation.

"We are once again very disappointed in this proposed delay of the 340B ceiling price and civil monetary penalties … these multiple delays are unjustified given the exhaustive rule development process that has already occurred," he said in an official statement. "We urge the agency to implement this final rule without any further delay to shine needed light on drug company price increases."

4. HHS is accepting comments on the proposed rule until May 25. If approved, the action would represent the regulation's fifth delay since its 2010 introduction.

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