0906-AB25 202104 Unified Agenda of Federal Regulatory and Deregulatory Actions 0906 Health Resources and Services Administration HRSA 0900 Department of Health and Human Services HHS Rescission of the Final Rule "Implementation of Executive Order on Access to Affordable Life-Saving Medications"

This final rule will provide access to life-saving medications by low-income individuals who do not have access to affordable insulin and injectable epinephrine due to either lack of insurance or high cost sharing requirements.  Based on comments in response to both the proposed rule published at 85 FR 60748 (September 28, 2020) and the proposed rule published at 86 FR 13872 (March 11, 2021), which indicated concerns that administrative costs and related burdens required by health centers to comply with the rule and the loss of 340B savings that would result from the rule taking effect would reduce resources available to support critical services for patients, HHS is considering a proposed rulemaking to rescind the final rule of December 23, 2020.

]]> Other Significant Previously Published in The Unified Agenda Completed Actions No No 42 CFR 51c sec. 330 of the PHS Act, 89 Stat. 342, (42 U.S.C. 254c) sec. 215 of the PHS Act, 58 Stat. 690, (42 U.S.C. 216) Yes NPRM 09/28/2020 85 FR 60748 NPRM Comment Period End 10/28/2020 Final Action 12/23/2020 85 FR 83822 Final Action Effective 03/22/2021 Final Action 01/26/2021 86 FR 7059 Final Action Effective 03/22/2021 Second NPRM 03/11/2021 86 FR 13872 Second NPRM Comment Period End 03/14/2021 Final Action 03/23/2021 86 FR 15423 Final Action Effective 07/20/2021 No No None No No No No Jennifer Joseph Director 0906 Health Resources and Services Administration HRSA 301 443-7355 jjoseph@hrsa.gov 5600 Fishers Lane, 16N21, Rockville MD 20857