Health and Human Services Department Proposed Rule

2021-12545: Proposed Rescission of Executive Order 13937, “Executive Order on Access to Affordable Life-Saving Medications”

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Summary

The Department of Health and Human Services (HHS) proposes to rescind the final rule entitled "Implementation of Executive Order on Access to Affordable Life-Saving Medications," published in the December 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. These challenges would be significantly exacerbated by the multitude of demands on health centers related to the COVID-19 pandemic. HHS is seeking public comment on this notice of proposed rulemaking (NPRM). As Executive Order 13937 remains in effect, should the final rule be rescinded, other implementation approaches will be considered to effectuate the Executive Order.

The agency’s own summary, as published.

What this changes

Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.

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