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Healthcare Providers Tells HHS to Stop Stalling 340B Rule

Posted on Tuesday, May 29, 2018 7:25 PM

Hospitals are joining forces in asking Health and Human Services (HHS) to stop delaying the implementation of the 340B regulations to police drug manufacturer pricing and overcharges.  They are asking the Trump Administration to enforce the rules immediately. 

“In 2010, Congress ordered HHS to issue regulations establishing civil monetary penalties for manufacturers that “knowingly and intentionally charge a covered entity more than the ceiling price for a covered outpatient drug.” Under the Obama administration, HHS published a proposed rule in June 2015 and a final rule in January 2017 that was to take effect in April 2017. The new Trump administration delayed the effective date shortly after it took office and has extended that delay three more times. It is due to take effect July 1, but HHS has proposed an additional one-year postponement.”

Drug companies on the other hand are asking for the continued delay.  “In stark contrast, pharmaceutical manufacturers and biotech companies submitted comments supporting HHS’s proposed yearlong delay. “The Final Rule needs substantial changes and allowing it to take effect before those changes have been made would be counterproductive and costly,” Pharmaceutical Research and Manufacturers of America commented.”

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