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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Rules and Regulations Affordable Life-Saving Medications rule. The 2021 NPRM provided for a 30day comment period, and HHS received 332 comments. HHS carefully considered all comments in developing this rule, as outlined in Section VI
below, and presents a summary of all significant comments and HHS
responses.

FR Doc. 202121164 Filed 93021; 8:45 am BILLING CODE 656050P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 51c RIN 0906AB30

Implementation of Executive Order on Access to Affordable Life-Saving Medications; Rescission of Regulation Health Resources and Services Administration HRSA, Department of Health and Human Services HHS.
ACTION: Final rule; rescission of regulations.
AGENCY:

HHS is rescinding the final rule entitled Implementation of Executive Order on Access to Affordable Life-Saving Medications, published in the December 23, 2020, Federal Register 2020 Rule. HHS is rescinding the 2020
Rule due to the excessive administrative costs and burdens that implementation would have imposed on health centers.
In particular, the 2020 Rule required health centers to create and maintain new practices necessary to determine patients eligibility to receive certain drugs at or below the discounted price paid by the health center or subgrantees plus a minimal administration fee. HHS
finds the 2020 Rules implementation would have resulted in reduced resources available to support critical services to health center patients including those who use insulin and injectable epinephrine. HHSs consideration of the 2020 Rules impact was informed, in part, by the demands on health centers resulting from the COVID19 pandemic. As Executive Order 13937 remains in effect, HHS is exploring non-regulatory options to implement the Executive Order.
DATES: This rule is effective November 1, 2021.
FOR FURTHER INFORMATION CONTACT:
Jennifer Joseph, Director, Office of Policy and Program Development, Bureau of Primary Health Care, Health Resources and Services Administration, 5600 Fishers Lane, Rockville, Maryland 20857; email: jjoseph@hrsa.gov;
telephone: 3015944300; fax: 301
5944997.
SUPPLEMENTARY INFORMATION:
SUMMARY:

I. Public Participation On June 16, 2021, HHS published a Notice of Proposed Rulemaking 2021
NPRM in the Federal Register 86 FR
32008 to rescind the Implementation of Executive Order on Access to
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II. Background HHS published the subject NPRM in the Federal Register on September 28, 2020 85 FR 60748, and the 2020 Rule on December 23, 2020 85 FR 83822.
The 2020 Rule established a new requirement directing all health centers receiving grants under section 330e of the Public Health Service Act 42 U.S.C.
254be that participate in the 340B
Program 42 U.S.C. 256b, to the extent that they plan to make insulin and/or injectable epinephrine available to their patients, to provide assurances that they have established practices to provide these drugs at or below the discounted price paid by the health center or subgrantees under the 340B Program plus a minimal administration fee to health center patients with low incomes, as determined by the Secretary, who have a high cost sharing requirement for either insulin or injectable epinephrine; have a high unmet deductible; or who have no health insurance.
On June 16, 2021, after a careful reassessment of the comments submitted in response to the proposed rule published at 85 FR 60748
September 28, 2020 and consideration of the comments received on the proposed rule to delay the effective date published at 86 FR 13872 March 11, 2021, HHS published the 2021 NPRM
to rescind the 2020 Rule. The 2021
NPRM cited significant concerns regarding health centers needing to divert vital resources to implement the 2020 Rule. The 2021 NPRM requested comment on the administrative burden and costs to comply with the 2020 Rule and thus maintain eligibility for future Health Center Program grants. The 2021
NPRM also requested comment on whether a rescission would assist health centers in continuing to provide primary care services to medically underserved and vulnerable populations. HHS noted the administrative burdens associated with the 2020 Rule, particularly in light of health centers continuing role in ensuring equitable access to COVID19
vaccination and maintaining the capacity to provide primary and preventive care that addresses the ongoing and evolving needs of hard-toreach and disproportionately affected
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populations. HHS also noted that the 2020 Rule would carry increased administrative costs and administrative burden and would result in reduced resources being available to support services to health center patients. In addition, most comments submitted previously noted that, in many cases, health centers already voluntarily provided medications at reduced prices to their patients.
The 2021 NPRM comment period ended on July 16, 2021. After review and consideration of all submitted comments, HHS has concluded that the 2020 Rule created excessive administrative burden for health centers, which in turn would have resulted in reduced resources for health center patient services. HHS has determined that the overall impacts of the administrative burden outweigh benefits to patients from the reduction in prices of insulin and injectable epinephrine. Therefore, HHS is issuing this final rule rescinding the 2020 Rule, which was published at 85 FR 83822.
The 2020 Rule became effective on July 20, 2021, prior to publication of this rescission. Due to the timing of Health Center Program funding, grants awarded in Fiscal Year 2022 would be the first opportunity for HRSA to impose the requirements of the Implementation of Executive Order on Access to Affordable Life-Saving Medications rule, and so the requirements have not yet been implemented.
III. Statutory Authority The statement of authority for 42 CFR
part 51c cites to sections 330 42 U.S.C.
254b and 215 of the Public Health Service Act, 42 U.S.C. 216, respectively.
IV. Overview of This Rule HHS is rescinding the 2020 Rule and therefore deleting the associated revision to the regulations codified at 42
CFR 51c.303w. 42 CFR 51c.303w stated: To the extent that an applicant for funding under Section 330e of the Public Health Service Act 42 U.S.C.
254be has indicated that it plans to distribute, either directly, or through a written agreement, drugs purchased through the 340B Drug Pricing Program 42 U.S.C. 256b, and to the extent that such applicant plans to make insulin and/or injectable epinephrine available to its patients, the applicant shall provide an assurance that it has established practices to provide insulin and injectable epinephrine at or below the discounted price paid by the health center grantee or subgrantee under the 340B Drug Pricing Program plus a
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