The Biden administration caught health center leaders off guard by not explicitly instructing HHS's new leadership to put a Trump administration 340B-related rule on ice. | Source: Shutterstock

Health Centers Scramble to Secure a Freeze on 340B Insulin Rule

Community health center leaders are concerned that the Biden administration yesterday asked, but did not order, the U.S. Health and Human Services Department (HHS) to postpone tomorrow’s scheduled implementation of a controversial Trump administration final rule that will require health centers to provide insulin and injectable epinephrine to low-income patients at the price centers pay for those drugs under the 340B program.

The new administration yesterday sent a memo to U.S. Health and Human Services (HHS) Acting Secretary Norris Cochran and all other heads of federal executive departments and agencies about how to handle new or pending rules written by the Trump administration. It asks department and agency heads only to “consider” postponing for 60 days the effective date of rules that the last administration published in the Federal Register but that have not yet taken effect, and to “consider” opening a 30-day public comment period for such rules.

Health center leaders had hoped the new administration would have required that such rules be postponed. Tomorrow Jan. 22 is the effective date of the controversial Trump administration final rule that will force health centers to pass all their 340B program savings on insulin and epinephrine autoinjectors to low-income, uninsured, and underinsured patients.

Health centers say they agree something must be done to make insulin more affordable for patients. But, they say, taking away their 340B savings on insulin is not the solution. In September, 104 U.S. House Democrats asked U.S. Health and Human Services (HHS) Secretary Alex Azar to rescind or not implement former President Trump’s July executive order requiring community health centers to pass along all 340B savings on insulin and injectable epinephrine to low-income patients. 

The Biden administration’s regulatory freeze memo came late yesterday afternoon, with the federal government closed for the inauguration and with new acting leaders installed just an hour or two earlier at both HHS and the U.S. Health Resources and Services Administration (HRSA). Health centers leaders had only last night and have only today to lean on HHS Acting Secretary Cochran and HRSA Acting Administrator Diane Espinosa to postpone the 340B insulin regulation.

“Health centers already ensure that uninsured and underinsured patients receive the insulin and epinephrine they are prescribed, regardless of ability to pay, and can ill-afford to implement an unnecessary, complex, and in many cases unworkable system as they continue to fight the COVID-19 pandemic and vaccinate the public,” attorney Jason Reddish, who represents health centers, told 340B Report late yesterday. “We certainly expect that the Biden administration will suspend the January 22 effective date of the rule rushed out in December and consider the many serious concerns raised by stakeholders and commenters about the rule and the executive order that led to it.”

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