The Biden administration has placed a freeze on implementing a Department of Health and Human Services regulatory rule put in place under President Donald Trump that requires community health centers to charge low-income patients the acquisition price for insulin and EpiPens.
“HHS signed off on the rule in December, shortly before former President Donald Trump left office. It aims to lower patients’ out-of-pocket costs by forcing community clinics to pass on their 340B drug discounts,” Modern Healthcare reported Thursday.
Health centers that did not comply with the rule would be blocked from receiving federal grant funds.
On Dec. 30, the HHS Office of the General Counsel released an advisory legal opinion concluding the rule could be implemented.
“The 340B Program requires drug manufacturers (in exchange for coverage of drugs under Medicaid) to offer substantial discounts to ‘covered entities,’ which include safety net hospitals, community health centers, and other institutions that serve vulnerable populations,” the department said in a news release.
Then-HHS Secretary Alex Azar said at the time, “President Trump has been steadfastly devoted to lowering drug prices for American patients, and that includes ensuring that drug companies are offering the discounts they’re legally required to give to providers that serve the vulnerable.”
In a July news release announcing the proposed change in response to a Trump executive order, HHS said the rule would “increase access to life-saving insulin and epinephrine for the patients who face especially high costs among the 28 million patients who visit [federally qualified health centers] every year, over six million of whom are uninsured.”
The Health and Human Services rule was slated to take effect Friday but has been delayed, pending a review by the Biden administration, until March 22, Modern Healthcare reported.
— Rupali Chadha, M.D.🩺 (@RupaliChadhaMD) January 22, 2021
The pause in implementing the drug pricing discount to patients is part of a larger regulatory freeze issued by White House Chief of Staff Ron Klain on Wednesday, President Joe Biden’s first day in office.
A memo from Klain directed all heads of departments and executive agencies to consider postponing rules’ effective dates for 60 days.
The document did provide for exceptions for “emergency situations or other urgent circumstances relating to health, safety, environmental, financial, or national security matters.”
Trump made a priority out of lowering prescription drug prices for Americans.
The Associated Press reported prices fell in 2018 for the first time in 45 years.
The order required that Medicare pay no more for a drug than the lowest price in countries in the Organization for Economic Cooperation and Development.
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