Medicare Program; Durable Medical Equipment Fee Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Rural Areas and Non-Contiguous Areas; Extension of Timeline for Final Rule Publication, 21949-21950 [2021-08661]
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Federal Register / Vol. 86, No. 78 / Monday, April 26, 2021 / Rules and Regulations
accordance with the provisions of E.O.
12866 and has determined that it does
not meet the criteria for a significant
regulatory action. As indicated above,
the provisions contained in this final
rulemaking set forth the inflation
adjustments in compliance with the
Debt Collection Improvement Act of
1996 for specific applicable CMPs. The
great majority of individuals,
organizations and entities addressed
through these regulations do not engage
in such prohibited conduct, and as a
result, we believe that any aggregate
economic impact of these revised
regulations will be minimal, affecting
only those limited few who may engage
in prohibited conduct in violation of the
statute. As such, this final rule and the
inflation adjustment contained therein
should have no effect on Federal or state
expenditures.
V. Regulatory Flexibility Act
The Administrator of General Services
certifies that this final rule will not have
a significant economic impact on a
substantial number of small business
entities. While some penalties may have
an impact on small business entities, it
is the nature of the violation and not the
size of the entity that will result in an
action by the agency, and the aggregate
economic impact of this rulemaking on
small business entities should be
minimal, affecting only those few who
have engaged in prohibited conduct in
violation of statutory intent.
VI. Paperwork Reduction Act
This final rule imposes no new
reporting or recordkeeping requirements
necessitating clearance by OMB.
List of Subject in 41 CFR Part 105–70
Administrative hearing, Claims,
Program fraud.
Katy Kale,
Acting Administrator.
Accordingly, 41 CFR part 105–70 is
amended as set forth below:
PART 105–70—IMPLEMENTATION OF
THE PROGRAM FRAUD CIVIL
REMEDIES ACT OF 1986
1. The authority citation for part 105–
70 continues to read as follows:
■
Authority: 40 U.S.C. 121(c); 31 U.S.C.
3809.
§ 105–70.003
[Amended]
2. Amend § 105–70.003 by—
a. Removing from paragraph (a)(1)(iv)
the amount ‘‘11,282’’ and adding
‘‘11,400’’ in its place; and
■
■
VerDate Sep<11>2014
16:01 Apr 23, 2021
Jkt 253001
b. Removing from paragraph (b)(1)(ii)
the amount ‘‘11,282’’ and adding
‘‘11,400’’ in its place.
■
[FR Doc. 2021–08600 Filed 4–23–21; 8:45 am]
BILLING CODE 6820–81–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 414
[CMS–1687–RCN]
RIN 0938–AT21
Medicare Program; Durable Medical
Equipment Fee Schedule Adjustments
To Resume the Transitional 50/50
Blended Rates To Provide Relief in
Rural Areas and Non-Contiguous
Areas; Extension of Timeline for Final
Rule Publication
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Continuation of effectiveness
and extension of timeline for
publication of the final rule.
AGENCY:
This document announces the
continuation of effectiveness of a
Medicare interim final rule and the
extension of the timeline for publication
of the final rule. Section 1871(a)(3)(B) of
the Social Security Act (the Act)
specifies that a Medicare final rule must
be published no later than 3 years after
the publication date of the proposed or
interim final rule, except under
exceptional circumstances. In
accordance with sections 1871(a)(3)(B)
and 1871(a)(3)(C) of the Act, we are
providing a notification of continuation
for a Medicare interim final rule,
announcing the different timeline on
which we intend to publish the final
rule, and explaining why we were
unable to publish the final rule on the
regular, required 3-year timeline.
DATES: As of April 23, 2021, the
Medicare provisions adopted in the
interim final rule published on May 11,
2018 (83 FR 21912) continue in effect
and the regular timeline for publication
of the final rule is extended for an
additional year, until May 11, 2022.
FOR FURTHER INFORMATION CONTACT:
Alexander Ullman, (410) 786–9671 or
DMEPOS@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: In the May
11, 2018 Federal Register (83 FR
21912), we published an interim final
rule with comment period (IFC) titled
‘‘Medicare Program; Durable Medical
SUMMARY:
PO 00000
Frm 00033
Fmt 4700
Sfmt 4700
21949
Equipment Fee Schedule Adjustments
to Resume the Transitional 50/50
Blended Rates to Provide Relief in Rural
Areas and Non-Contiguous Areas’’. The
May 2018 IFC made technical
amendments to the regulation to reflect
the extension of the transition period
from June 30, 2016 to December 31,
2016 that was mandated by the 21st
Century Cures Act for phasing in fee
schedule adjustments for certain
durable medical equipment (DME) and
enteral nutrition furnished in areas not
subject to the Durable Medical
Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS) Competitive
Bidding Program (CBP) (83 FR 21915).
In addition, in the May 2018 IFC,
CMS—(1) amended 42 CFR 414.210(g)
to resume the transition period’s
blended fee schedule rates for items
furnished in rural areas and noncontiguous areas (Alaska, Hawaii, and
United States territories) not subject to
the CBP from June 1, 2018 through
December 31, 2018 (83 FR 21915); (2)
made technical amendments to existing
DMEPOS regulations to reflect the
exclusion of infusion drugs used with
DME from the DMEPOS CBP (83 FR
21919); and (3) stated that the fee
schedule amounts for wheelchair
accessories and back and seat cushions
used in conjunction with group 3 power
wheelchairs would continue to be based
on the unadjusted fee schedule amounts
updated by the covered item update
specified in section 1834(a)(14) of the
Act (83 FR 21919). We stated that the
fee schedule amounts for all other
accessories used with different types of
base equipment would continue to be
calculated in accordance with the
adjustment methodology set forth in
§ 414.210(g)(5) of our regulations (83 FR
21919).
Section 1871(a)(3)(B) of the Act
requires CMS to publish a Medicare
final rule no later than 3 years after the
publication of a proposed or interim
final rule, except under exceptional
circumstances. In such circumstances,
section 1871(a)(3)(B) of the Act allows
the Secretary to vary the final regulation
publication timeline if the Secretary
provides public notice of the different
timeline on which it intends to publish
the final regulation, and that notice
includes a brief explanation of the
justification for the variation. The notice
must be published by no later than the
timeline previously established with
respect to the final rule publication
date.
The May 2018 IFC was published on
May 11, 2018. Therefore, in accordance
with section 1871(a)(3)(B) of the Act, we
must finalize the May 2018 IFC by May
11, 2021, except under exceptional
E:\FR\FM\26APR1.SGM
26APR1
21950
Federal Register / Vol. 86, No. 78 / Monday, April 26, 2021 / Rules and Regulations
circumstances. We will not be able to
finalize the May 2018 IFC within the
required 3-year timeline for publication
(by May 11, 2021) for the following
reasons:
In the November 4, 2020 Federal
Register (85 FR 70358), we published a
proposed rule titled ‘‘Medicare Program;
Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies
(DMEPOS) Policy Issues and Level II of
the Healthcare Common Procedure
Coding System (HCPCS)’’ (hereinafter
DMEPOS and HCPCS proposed rule). In
the DMEPOS and HCPCS proposed rule
(85 70373), we stated that we solicited
comments on the 2018 Interim Final
Rule, but because we have not yet
responded to the comments we
received, we are signaling our intent to
do so in the final rule.
On January 20, 2021, the Assistant to
the President and Chief of Staff issued
a memorandum concerning ‘‘Regulatory
Freeze Pending Review’’ (‘‘Regulatory
Freeze memorandum’’).1 The Office of
Management and Budget (OMB) issued
Memorandum M–21–14 on January 20,
2021, providing guidance on
implementing the Regulatory Freeze
memorandum.2 The Regulatory Freeze
memorandum seeks to ensure that the
President’s appointees or designees
have the opportunity to review any new
or pending rules. Paragraph 1 of the
Regulatory Freeze memorandum directs
agencies, subject to any exceptions the
Director of the OMB allows for
emergency situations or other urgent
circumstances relating to health, safety,
environmental, financial, or national
security matters, or otherwise, to
propose or issue no rule in any
manner—including by sending a rule to
the Office of the Federal Register—until
a department or agency head appointed
or designated by the President after
noon on January 20, 2021, reviews and
approves the rule. Additionally,
paragraph 3 of the Regulatory Freeze
memorandum describes the agency
option to temporarily postpone agency
rules to permit review by an agency
head appointed or designated by the
President after noon on January 20,
2021.
In light of our efforts to comply with
the Regulatory Freeze memorandum,
and to allow policy officials in the new
administration the opportunity to
review the DMEPOS and HCPCS
proposed rule and May 2018 IFC, we do
not believe we will have sufficient time
1 https://www.whitehouse.gov/briefing-room/
presidential-actions/2021/01/20/regulatory-freezepending-review/ (86 FR 7424, January 28, 2021).
2 https://www.whitehouse.gov/wp-content/
uploads/2021/01/M-21-14-Regulatory-Review.pdf.
VerDate Sep<11>2014
16:01 Apr 23, 2021
Jkt 253001
to finalize the IFC, and relatedly the
DMEPOS and HCPCS proposed rule, by
the May 11, 2021 deadline. As a result
of these exceptional circumstances, we
are issuing this notification of
continuation and extending the timeline
for finalizing the May 2018 IFC by 1
year. This extension will grant policy
officials the opportunity to review the
DMEPOS and HCPCS proposed rule and
the May 2018 IFC. In accordance with
section 1871(a)(3)(C) of the Act, this
notification of continuation also ensures
that the May 2018 IFC continues in
effect beyond May 11, 2021. As a result
of the publication of this notification of
continuation, the timeline for
publication of the final rule will be
treated as having been extended until
May 11, 2022.
Dated: April 21, 2021.
Wilma Robinson,
Deputy Executive Secretary to the
Department, Department of Health and
Human Services.
[FR Doc. 2021–08661 Filed 4–23–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 17
[Docket No. FWS–HQ–ES–2017–0047;
FF09E22000 FXES11180900000 212]
RIN 1018–BC83
Endangered and Threatened Wildlife
and Plants; Listing the Yangtze
Sturgeon as an Endangered Species
Fish and Wildlife Service,
Interior.
ACTION: Final rule.
AGENCY:
We, the U.S. Fish and
Wildlife Service (Service), determine
endangered species status under the
Endangered Species Act of 1973 (Act),
as amended, for the Yangtze sturgeon
(Acipenser dabryanus). Loss of
individuals due to overharvesting on the
Yangtze River is the main factor that
contributed to the historical decline of
the species. Despite conservation efforts,
this species is still currently in decline,
due primarily to the effects of dams and
bycatch. This rule adds the Yangtze
sturgeon to the List of Endangered and
Threatened Wildlife.
DATES: This rule is effective May 26,
2021.
SUMMARY:
Comments and materials
received, as well as supporting
documentation used in the preparation
of this rule, are available for public
ADDRESSES:
PO 00000
Frm 00034
Fmt 4700
Sfmt 4700
inspection at https://
www.regulations.gov under Docket No.
FWS–HQ–ES–2017–0047.
FOR FURTHER INFORMATION CONTACT:
Maricela Constantino, Acting Chief,
Branch of Delisting and Foreign Species,
Ecological Services Program, U.S. Fish
and Wildlife Service, 5275 Leesburg
Pike, MS: ES, Falls Church, VA 22041;
telephone 703–358–2171. If you use a
telecommunications device for the deaf
(TDD), call the Federal Relay Service at
800–877–8339.
SUPPLEMENTARY INFORMATION:
Previous Federal Actions
On December 27, 2017, we published
in the Federal Register (82 FR 61230) a
12-month finding and proposed rule to
list the Yangtze sturgeon (Acipenser
dabryanus) as an endangered species
under the Act. A thorough review of the
taxonomy, life history, ecology, and
overall viability of the Yangtze sturgeon
is also presented in the species status
assessment (SSA) for the Yangtze
sturgeon (Service 2017; available at
https://www.regulations.gov at Docket
No. FWS–HQ–ES–2017–0047), and a
summary of this information, including
the history of previous federal actions,
a summary of the species’ description,
taxonomy, biology, life history, habitat,
distribution, and historical and current
population, is provided in our
December 27, 2017, proposed rule (82
FR 61230).
Summary of Changes From the
Proposed Rule
We received one comment from a peer
reviewer providing additional
information regarding ongoing and new
conservation efforts on the Yangtze
River, which include lengthening
fishing bans within the species’ range
and the commencement of restocking
efforts on reaches below Gezhouba Dam.
We have incorporated this information
into this rule and have updated our
species status assessment (SSA) report.
Supporting Documents
A species status assessment team
prepared an SSA report for the Yangtze
sturgeon. The SSA team was composed
of Service biologists, in consultation
with other species experts. The SSA
report represents a compilation of the
best scientific and commercial data
available concerning the status of the
species, including the impacts of past,
present, and future factors (both
negative and beneficial) affecting the
species.
In accordance with our joint policy on
peer review published in the Federal
Register on July 1, 1994 (59 FR 34270),
and our August 22, 2016, memorandum
E:\FR\FM\26APR1.SGM
26APR1
]]>Agencies
[Federal Register Volume 86, Number 78 (Monday, April 26, 2021)]
[Rules and Regulations]
[Pages 21949-21950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08661]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 414
[CMS-1687-RCN]
RIN 0938-AT21
Medicare Program; Durable Medical Equipment Fee Schedule
Adjustments To Resume the Transitional 50/50 Blended Rates To Provide
Relief in Rural Areas and Non-Contiguous Areas; Extension of Timeline
for Final Rule Publication
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Continuation of effectiveness and extension of timeline for
publication of the final rule.
-----------------------------------------------------------------------
SUMMARY: This document announces the continuation of effectiveness of a
Medicare interim final rule and the extension of the timeline for
publication of the final rule. Section 1871(a)(3)(B) of the Social
Security Act (the Act) specifies that a Medicare final rule must be
published no later than 3 years after the publication date of the
proposed or interim final rule, except under exceptional circumstances.
In accordance with sections 1871(a)(3)(B) and 1871(a)(3)(C) of the Act,
we are providing a notification of continuation for a Medicare interim
final rule, announcing the different timeline on which we intend to
publish the final rule, and explaining why we were unable to publish
the final rule on the regular, required 3-year timeline.
DATES: As of April 23, 2021, the Medicare provisions adopted in the
interim final rule published on May 11, 2018 (83 FR 21912) continue in
effect and the regular timeline for publication of the final rule is
extended for an additional year, until May 11, 2022.
FOR FURTHER INFORMATION CONTACT: Alexander Ullman, (410) 786-9671 or
[email protected].
SUPPLEMENTARY INFORMATION: In the May 11, 2018 Federal Register (83 FR
21912), we published an interim final rule with comment period (IFC)
titled ``Medicare Program; Durable Medical Equipment Fee Schedule
Adjustments to Resume the Transitional 50/50 Blended Rates to Provide
Relief in Rural Areas and Non-Contiguous Areas''. The May 2018 IFC made
technical amendments to the regulation to reflect the extension of the
transition period from June 30, 2016 to December 31, 2016 that was
mandated by the 21st Century Cures Act for phasing in fee schedule
adjustments for certain durable medical equipment (DME) and enteral
nutrition furnished in areas not subject to the Durable Medical
Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive
Bidding Program (CBP) (83 FR 21915). In addition, in the May 2018 IFC,
CMS--(1) amended 42 CFR 414.210(g) to resume the transition period's
blended fee schedule rates for items furnished in rural areas and non-
contiguous areas (Alaska, Hawaii, and United States territories) not
subject to the CBP from June 1, 2018 through December 31, 2018 (83 FR
21915); (2) made technical amendments to existing DMEPOS regulations to
reflect the exclusion of infusion drugs used with DME from the DMEPOS
CBP (83 FR 21919); and (3) stated that the fee schedule amounts for
wheelchair accessories and back and seat cushions used in conjunction
with group 3 power wheelchairs would continue to be based on the
unadjusted fee schedule amounts updated by the covered item update
specified in section 1834(a)(14) of the Act (83 FR 21919). We stated
that the fee schedule amounts for all other accessories used with
different types of base equipment would continue to be calculated in
accordance with the adjustment methodology set forth in Sec.
414.210(g)(5) of our regulations (83 FR 21919).
Section 1871(a)(3)(B) of the Act requires CMS to publish a Medicare
final rule no later than 3 years after the publication of a proposed or
interim final rule, except under exceptional circumstances. In such
circumstances, section 1871(a)(3)(B) of the Act allows the Secretary to
vary the final regulation publication timeline if the Secretary
provides public notice of the different timeline on which it intends to
publish the final regulation, and that notice includes a brief
explanation of the justification for the variation. The notice must be
published by no later than the timeline previously established with
respect to the final rule publication date.
The May 2018 IFC was published on May 11, 2018. Therefore, in
accordance with section 1871(a)(3)(B) of the Act, we must finalize the
May 2018 IFC by May 11, 2021, except under exceptional
[[Page 21950]]
circumstances. We will not be able to finalize the May 2018 IFC within
the required 3-year timeline for publication (by May 11, 2021) for the
following reasons:
In the November 4, 2020 Federal Register (85 FR 70358), we
published a proposed rule titled ``Medicare Program; Durable Medical
Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues
and Level II of the Healthcare Common Procedure Coding System (HCPCS)''
(hereinafter DMEPOS and HCPCS proposed rule). In the DMEPOS and HCPCS
proposed rule (85 70373), we stated that we solicited comments on the
2018 Interim Final Rule, but because we have not yet responded to the
comments we received, we are signaling our intent to do so in the final
rule.
On January 20, 2021, the Assistant to the President and Chief of
Staff issued a memorandum concerning ``Regulatory Freeze Pending
Review'' (``Regulatory Freeze memorandum'').\1\ The Office of
Management and Budget (OMB) issued Memorandum M-21-14 on January 20,
2021, providing guidance on implementing the Regulatory Freeze
memorandum.\2\ The Regulatory Freeze memorandum seeks to ensure that
the President's appointees or designees have the opportunity to review
any new or pending rules. Paragraph 1 of the Regulatory Freeze
memorandum directs agencies, subject to any exceptions the Director of
the OMB allows for emergency situations or other urgent circumstances
relating to health, safety, environmental, financial, or national
security matters, or otherwise, to propose or issue no rule in any
manner--including by sending a rule to the Office of the Federal
Register--until a department or agency head appointed or designated by
the President after noon on January 20, 2021, reviews and approves the
rule. Additionally, paragraph 3 of the Regulatory Freeze memorandum
describes the agency option to temporarily postpone agency rules to
permit review by an agency head appointed or designated by the
President after noon on January 20, 2021.
---------------------------------------------------------------------------
\1\ https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/regulatory-freeze-pending-review/ (86 FR 7424,
January 28, 2021).
\2\ https://www.whitehouse.gov/wp-content/uploads/2021/01/M-21-14-Regulatory-Review.pdf.
---------------------------------------------------------------------------
In light of our efforts to comply with the Regulatory Freeze
memorandum, and to allow policy officials in the new administration the
opportunity to review the DMEPOS and HCPCS proposed rule and May 2018
IFC, we do not believe we will have sufficient time to finalize the
IFC, and relatedly the DMEPOS and HCPCS proposed rule, by the May 11,
2021 deadline. As a result of these exceptional circumstances, we are
issuing this notification of continuation and extending the timeline
for finalizing the May 2018 IFC by 1 year. This extension will grant
policy officials the opportunity to review the DMEPOS and HCPCS
proposed rule and the May 2018 IFC. In accordance with section
1871(a)(3)(C) of the Act, this notification of continuation also
ensures that the May 2018 IFC continues in effect beyond May 11, 2021.
As a result of the publication of this notification of continuation,
the timeline for publication of the final rule will be treated as
having been extended until May 11, 2022.
Dated: April 21, 2021.
Wilma Robinson,
Deputy Executive Secretary to the Department, Department of Health and
Human Services.
[FR Doc. 2021-08661 Filed 4-23-21; 8:45 am]
BILLING CODE 4120-01-P
