[Federal Register Volume 86, Number 46 (Thursday, March 11, 2021)]
[Proposed Rules]
[Pages 13872-13873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05165]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 51c

RIN 0906-AB25


Implementation of Executive Order on Access to Affordable Life-
Saving Medications; Delay of Effective Date

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Proposed delay of effective date; request for comments.

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SUMMARY: In accordance with the Presidential directive as expressed in 
the memorandum of January 20, 2021, from the Assistant to the President 
and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' this 
action proposes, following a 5-day public comment period, to further 
delay until July 20, 2021, the effective date of the rule entitled 
``Implementation of Executive Order on Access to Affordable Life-saving 
Medications'' published in the Federal Register on December 23, 2020. 
That final rule is currently scheduled to take effect on March 22, 
2021, after an initial delay from its original effective date of 
January 22, 2021. HHS seeks comments on this proposed delay of the 
effective date to July 20, 2021, which would allow it additional 
opportunity for review and consideration of the new rule. HHS will take 
comments about issues of fact, law, and policy raised by rule into 
account as the rule is reviewed during the delay period.

DATES: The effective date for the final rule published December 23, 
2020, at 85 FR 83822, delayed January 26, 2021, at 86 FR 7059, is 
proposed to be further delayed until July 20, 2021. Written comments 
and related material to this proposal must be received to the online 
docket via https://www.regulations.gov on or before March 14, 2021.

ADDRESSES: You may submit written comments electronically by the 
following method: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions on the website for 
submitting comments.
    Instructions. Include the HHS Docket No. HRSA-2021-0002 in your 
comments. All comments received will be posted without change to http://www.regulations.gov. Please do not include any personally identifiable 
or confidential business information you do not want publicly 
disclosed.

FOR FURTHER INFORMATION CONTACT: Jennifer Joseph, Director, Office of 
Policy and Program Development, Bureau of Primary Health Care, HRSA, 
5600 Fishers Lane, Rockville, MD 20857; by email at [email protected]; 
telephone: 301-594-4300; fax: 301-594-4997.

SUPPLEMENTARY INFORMATION: HHS published a notice of proposed 
rulemaking in the Federal Register on September 28, 2020 (85 FR 60748), 
and a final rule on December 23, 2020 (85 FR 83822), delayed on January 
26, 2021, at 86 FR 7069. The final rule, ``Implementation of Executive 
Order on Access to Affordable Life-Saving Medications,'' established a 
new requirement directing all health centers receiving grants under 
section 330(e) of the Public Health Service Act (42 U.S.C. 254b(e)) 
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 Drug Pricing 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.
    The January 20, 2021, memorandum from the Assistant to the 
President and Chief of Staff, entitled ``Regulatory Freeze Pending 
Review,'' instructed Federal agencies to consider delaying the 
effective date of rules published in the Federal Register, but which 
have not yet taken effect, for a period of 60 days so that the new 
Administration may review recently published rules for ``any questions 
of fact, law, and policy the rule may raise.'' The ``Implementation of 
Executive Order on Access to Affordable Life-Saving Medications'' rule 
falls within this category. On January 20, 2021, the Office of 
Management and Budget (OMB) also published OMB Memorandum M-21-14, 
Implementation of Memorandum Concerning Regulatory Freeze Pending 
Review, which provides guidance regarding the Regulatory Freeze 
Memorandum. See M-21-14, Implementation of Memorandum Concerning 
Regulatory Freeze Pending Review, https://www.whitehouse.gov/wp-content/uploads/2021/01/M-21-14-Regulatory-Review.pdf. OMB Memorandum 
M-21-14 explains that pursuant to the Regulatory Freeze Memorandum, 
agencies ``should

[[Page 13873]]

consider postponing the effective dates for 60 days and reopening the 
rulemaking process'' for ``rules that have not yet taken effect and 
about which questions involving law, fact, or policy have been 
raised.'' Id. In accordance with the Regulatory Freeze Memorandum and 
OMB M-21-14, HHS proposes to delay the effective date of the December 
23, 2020, final rule entitled ``Implementation of Executive Order on 
Access to Affordable Life-saving Medications'' to July 20, 2021.
    In addition, consistent with Regulatory Freeze Memorandum and OMB 
Memorandum M-21-14, the 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 is particularly interested in further 
consideration of previous comments regarding the impact of the rule's 
administrative requirements, costs of new processes and procedures that 
would be necessary 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. HHS is also interested in further review of the comments 
acknowledged in the final rule and additional information regarding 
these areas received by HHS subsequent to the issuance of the final 
rule. Specifically, comments acknowledged in the final rule expressed 
the concern that the rule would have the impact of (1) dramatically 
reducing 340B savings for health centers, (2) likely increasing the 
cost of life-saving medications nationwide, and (3) creating enormous 
administrative burdens for health centers, specifically because the 
NPRM proposed defining ``low-income'' as at or below 350 percent of the 
Federal Poverty Level (FPL), a different income threshold than the 200 
percent of FPL used by the Health Center Program to apply statutory 
requirements for sliding fee discount schedules under the Health Center 
Program's authorizing statute.
    HHS believes that the proposed delay is reasonable, would allow HHS 
time to receive public comment, and would not be disruptive since the 
underlying rule has not yet taken effect, and since neither HHS nor 
health centers have undertaken the administrative costs associated with 
implementation of the final rule.
    HHS seeks comment on the proposed delay, including the proposed 
delay's impact on any legal, factual, or policy issues raised by the 
underlying rule and whether further review of those issues warrants 
such a delay. HHS also will consider comments on the substance of the 
rule as the rule is reviewed during the delay period. HHS therefore 
seeks comment by March 14, 2021, on its proposal to extend the 
effective date to July 20, 2021.

Norris Cochran,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2021-05165 Filed 3-9-21; 4:15 pm]
BILLING CODE 4165-15-P