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Federal Register / Vol. 86, No. 54 / Tuesday, March 23, 2021 / Rules and Regulations
seq. requires that Federal agencies provide at least 30 days after publication of a final rule in the Federal Register before making it effective, unless good cause can be found not to do so. HHS finds that there is good cause for making this final rule effective less than 30 days after publication in the Federal Register given that failure to do so would result in the final rule going into effect before the delay begins.
Allowing for a 30-day delay between publication and the effective date is both unnecessary and impracticable, as it would undermine this rules objective of delaying the Implementation of Executive Order on Access to Affordable Life-saving Medications rule so that HHS can fully review it for questions of law, policy, and fact.
HHS has considered all comments in finalizing this rule, as outlined in Section III below, and presents a summary of all significant comments and HHS responses.
II. Background HHS published a NPRM in the Federal Register on September 28, 2020
85 FR 60748, and a final rule on December 23, 2020 85 FR 83822. The rule, Implementation of Executive Order on Access to Affordable LifeSaving Medications, 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
Drug Pricing Program 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 have no health insurance.
As stated in the NPRM, consistent with Regulatory Freeze Memorandum and OMB Memorandum M2114, a delay of the Implementation of Executive Order on Access to Affordable Life-saving Medications rule will provide HHS additional time to review and consider further questions of fact, law, and policy the rule may raise, including whether revision or withdrawal of the rule may be warranted. HHS invited comments on the impact of the rules administrative requirements, costs of new processes and procedures that would be necessary
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under the rule, the impact of the establishment of a new income eligibility threshold for health center operations, and the overall impact on care delivery and service levels for health center patients.
After HHS review of submitted comments, HHS believes that this delay is reasonable, and will allow HHS to consider the impact that the Implementation of Executive Order on Access to Affordable Life-saving Medications rule may have. The delay will also ensure that, consistent with concerns raised by commenters, implementation of the rule does not impede HHSs and health centers immediate priority work, on a nationwide basis, of responding to and mitigating the spread of COVID19, including ensuring equitable access to COVID19 vaccines, and maintaining the delivery of comprehensive primary health services to medically underserved populations, while considering how to address administrative/implementation issues raised by commenters and further address comments regarding the impact of the rule. In addition, the delay will not be disruptive since the Implementation of Executive Order on Access to Affordable Life-saving Medications rule has not yet taken effect and neither HHS nor health centers have undertaken the administrative changes associated with implementation of the rule.
III. Public Comments and Responses Consistent with Regulatory Freeze Memorandum and OMB Memorandum M2114, HHS requested comment on whether a delay of the final rule would provide HHS additional time to review and consider further questions of fact, law, and policy the rule may raise, including whether revision or withdrawal of the rule may be warranted. HHS stated that it would further consider comments regarding the impact of the rules administrative requirements, costs of new processes and procedures that would be necessary under the Implementation of Executive Order on Access to Affordable Lifesaving Medications rule, the impact of the establishment of a new income eligibility threshold for health center operations, and the overall impact on care delivery and service levels for health center patients.
HHS received a total of 198
comments. Commenters identified themselves as individuals requiring insulin or injectable epinephrine and their family members, health centers, associations and organizations representing health centers, a
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professional organization, a diabetes research foundation, a pharmaceutical manufacturer, and clinical professionals. The vast majority of comments 187 favored a further delay in the effective date of the Implementation of Executive Order on Access to Affordable Life-saving Medications rule. Three comments opposed further delay of the effective date for the Implementation of Executive Order on Access to Affordable Life-saving Medications rule and supported implementation of the rule, though one commenter opposed to a further delay also urged HHS to take steps to limit administrative burden to health centers. The remaining comments did not explicitly support or oppose the delay.
Many commenters 175, including many health centers, primary care associations, and a number of other individuals and organizations, including a Health Care Controlled Network and a Medicaid Accountable Care Organization, also strongly urged that the Implementation of Executive Order on Access to Affordable Lifesaving Medications rule be rescinded.
Three commenters supported implementation of the Implementation of Executive Order on Access to Affordable Life-saving Medications rule, although one of those commenters also supported a delay to allow health centers time to come into compliance with the regulation.
All comments were considered in developing this final rule. This section presents a summary of all major issues raised by commenters, grouped by subject, as well as responses to the comments. Commenters used the terms Federally Qualified Health Centers FQHCs and health centers interchangeably. For consistency, and as this rule applies to health centers funded under Section 330e of the PHS
Act and not to other FQHCs this final rule uses health center throughout.
1. Delay Implementation Based on Regulatory Freeze Pending Review Memo Approximately 181 commenters supported the delay as consistent with the Regulatory Freeze Pending Review issued by the White House Chief of Staff on January 20, 2021.
Specifically, commenters noted that this delay aligns with the Regulatory Freeze language to delay implementation where necessary to continue to review these questions of fact, law, and policy, and acknowledged the effort required for HHS to address those questions.
Response: HHS appreciates these comments and agrees that delaying the
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