[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