Perspective from Emily Kosirog, PharmD, BCACP
Disclosures: Coverden is president and CEO of NACHC.
January 26, 2021
3 min read
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Biden administration freezes rule on community health center insulin discounts

Perspective from Emily Kosirog, PharmD, BCACP
Disclosures: Coverden is president and CEO of NACHC.
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The Biden administration issued a temporary freeze on a final rule that would require community health centers to pass on 340B drug discounts for insulin and injectable epinephrine to low-income patients.

The executive order temporarily delays for 60 days the effective date of the final rule, titled “Implementation of Executive Order on Access to Affordable Life-saving Medications,” until March 22. The order, published Dec. 23, was to go into effect Jan. 22. The rule would apply to all health centers receiving section 330e grant funds that participate in the 340B drug pricing program, and requires such centers to make insulin and injectable epinephrine available to health center patients identified as low-income or below at the same price the health center paid through the 340B program.

insulin syringe
Source: Adobe Stock

“We are deeply grateful the Biden Administration put the brakes on such a harmful rule within hours of taking office,” Tom Van Coverden, president and CEO of National Association of Community Health Centers, said in a statement. “Health centers, bipartisan members of Congress, and leaders within the Department of Health and Human Services (HHS) have indicated that this rule will do more harm than good at a time when too many people are suffering. We hope that this is further acknowledgment that a pandemic is no time to destabilize the safety net.”

The freeze was part of a broader executive action issued Jan. 20 postponing most rules sent to the Office of the Federal Register for 60 days to allow for a review of “any questions of fact, law and policy the rules may raise” and to consider any pending petitions for reconsideration of rules.

“The temporary delay in the effective date of this final rule is necessary to give department officials the opportunity for further review and consideration of new regulations, consistent with the memorandum of January 20, 2021, from the assistant to the president and chief of staff, entitled ‘Regulatory Freeze Pending Review,’” the executive order states.

Community health centers voiced opposition to the rule when the Trump administration first announced the change. In September, the Office of Management and Budget revised the regulation from an interim final rule to a proposed rule, indicating that the public would have an opportunity to submit written comments before it goes into effect. At the time, the NACHC stated that the rule change would place additional administrative burdens on centers that assist vulnerable populations, instead of placing such a burden on pharmaceutical companies.

“We are deeply grateful that there seems to be growing recognition among leaders in the administration that this rule will do more harm than good at a time when too many people are suffering,” Van Coverden said in a press release in September, after the regulation was first revised.

For more information:

NACHC statement. Available at: www.nachc.org/fed-delays-implementation-of-340b-rule-after-health-centers-lawmakers-sound-alarm/. Accessed: Jan. 26, 2021.

The White House. Regulatory freeze pending review. Available at: www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/regulatory-freeze-pending-review/. Accessed: Jan. 26, 2021.