HHS delays implementation of rule requiring FQHCs to provide insulin, epinephrine at 340B prices

The Biden administration has further postponed a regulation that would require federally qualified health centers (FQHCs) to make certain drugs more affordable for low-income patients and will consider whether to withdraw the rule altogether.

Implementation of the “Executive Order on Access to Affordable Life-Saving Medications” has been postponed to July 20. The rule initially was set to take effect on Jan. 20 and then was postponed until March 22.

The order, signed last year by former President Donald Trump, would apply to FQHCs that participate in the 340B Drug Pricing Program and make insulin and injectable epinephrine available to patients. Those drugs must be provided to low-income and uninsured patients at or below 340B prices.

The U.S. Department of Health and Human Services (HHS) plans to use the delay period to review the rule and “consider further questions of fact, law and policy [that] the rule may raise, including whether revision or withdrawal of the rule may be warranted.”

The postponement also is intended “to ensure that implementation of the rule does not impede HHS’s and health centers’ immediate priority work, on a nationwide basis, of responding to and mitigating the spread of COVID-19 … and maintaining the delivery of comprehensive primary health services to medically underserved populations,” according to the new final rule implementing the delay.

Commenters strongly support tabling the rule

HHS stated that it received 198 comments from healthcare stakeholders on its proposal to table the rule until July. Of them, 187 supported the delay and 175 said the rule should be rescinded.

According to HHS, numerous commenters noted that “since the rule was initially delayed in January, health centers have been requested to perform a critical role in the national efforts to vaccinate hard-to-reach populations.”

HHS added, “Commenters stated that, in taking on this responsibility, health centers’ staff and resources are being stretched to unprecedented levels, making the administrative and financial burden of implementing the rule even more challenging.”