Biden administration proposes rescinding rule on community health center insulin discounts
The Biden administration proposed rescinding a final rule introduced under the Trump administration that would require community health centers to pass on 340B drug discounts for insulin and injectable epinephrine to low-income patients.
In a notice posted on its website June 16, the Department of Health and Human Services (HHS) proposed to rescind the final rule titled “Implementation of Executive Order on Access to Affordable Life-Saving Medications,” originally published in the Dec. 23, 2020, Federal Register. HHS is proposing the rescission due to “undue administrative costs and burdens” that implementation would impose on health centers.
“In particular, the final rule would require health centers to create and sustain new practices necessary to determine patients' eligibility to receive certain drugs at or below the discounted price paid by the health center or subgrantees under the 340B Program, resulting in reduced resources available to support critical services to their patients —including those who use insulin and injectable epinephrine,” the notice states. “These challenges would be significantly exacerbated by the multitude of demands on health centers related to the COVID-19 pandemic.”
As Healio previously reported, the Biden administration issued a temporary freeze on the final rule in January, delaying the effective date for 60 days, until March 22. The initial freeze was part of a broader executive action issued Jan. 20 postponing for 60 days most rules sent to the Office of the Federal Register 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 rule, if passed, would have applied to all health centers receiving section 330e grant funds that participate in the 340B drug pricing program, and would have required 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.
In a statement, the National Association for Community Health Centers (NACHC) said the rule would not increase access for patients and instead place an “immense burden” on the health center program.
“NACHC has consistently voiced concerns about the impact of this rule based on its proponents’ fundamental misunderstanding of the health center mission,” Tom Van Coverden, president and CEO of NACHC, said in a press release. “Under the 340B program health centers are required to invest every penny of savings back into patient care and will continue to provide patients affordable medications.”
HHS is seeking public comment on the notice of proposed rulemaking. Written comments and related material to the proposed rule must be received to the online docket via www.regulations.gov on or before July 16, 2021.
For more information:
NACHC statement. Available at: www.nachc.org/biden-administration-dismantles-insulin-epipen-rule-harmful-to-community-health-centers-and-patients/. Accessed: June 16, 2021.
Proposed Rescission of Executive Order 13937, “Executive Order on Access to Affordable Life-Saving Medications.” Available at: www.federalregister.gov/d/2021-12545. Accessed: June 16, 2021.