Medicare Program; CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy; Coding and Payment for Virtual Check-In Services Interim Final Rule Policy; Coding and Payment for Personal Protective Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in Response to the Public Health Emergency (PHE) for COVID-19; and Finalization of Certain Provisions From the March 31st, May 8th and September 2nd Interim Final Rules in Response to the PHE for COVID-19; Correction, 5020-5022 [2021-00805]
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<![CDATA[
5020
Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations
I. Background
In FR Doc. 2020–26815 of December
28, 2020, the CY 2021 PFS final rule (85
FR 84472), there were technical errors
that are identified and corrected in this
correcting document. These corrections
are effective and applicable beginning
January 1, 2021.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 400, 410, 414, 415, 423,
424, and 425
[CMS–1734–F, CMS–1734–IFC, CMS–1744–
F, CMS–5531–F and CMS–3401–IFC] CN
RIN 0938–AU10, 0938–AU31, 0938–AU32,
and 0938–AU33
Medicare Program; CY 2021 Payment
Policies Under the Physician Fee
Schedule and Other Changes to Part B
Payment Policies; Medicare Shared
Savings Program Requirements;
Medicaid Promoting Interoperability
Program Requirements for Eligible
Professionals; Quality Payment
Program; Coverage of Opioid Use
Disorder Services Furnished by Opioid
Treatment Programs; Medicare
Enrollment of Opioid Treatment
Programs; Electronic Prescribing for
Controlled Substances for a Covered
Part D Drug; Payment for Office/
Outpatient Evaluation and
Management Services; Hospital IQR
Program; Establish New Code
Categories; Medicare Diabetes
Prevention Program (MDPP) Expanded
Model Emergency Policy; Coding and
Payment for Virtual Check-In Services
Interim Final Rule Policy; Coding and
Payment for Personal Protective
Equipment (PPE) Interim Final Rule
Policy; Regulatory Revisions in
Response to the Public Health
Emergency (PHE) for COVID–19; and
Finalization of Certain Provisions From
the March 31st, May 8th and
September 2nd Interim Final Rules in
Response to the PHE for COVID–19;
Correction
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule and interim final rule;
Correction.
AGENCY:
This document corrects
technical errors in the final rule that
appeared in the December 28, 2020,
Federal Register under the same as title
above. Hereinafter, the December 28
rule is referred to as the CY 2021 PFS
final rule.
DATES: This correction is effective
January 19, 2021, and is applicable
beginning January 1, 2021.
FOR FURTHER INFORMATION CONTACT:
Cynthia Lambert-Lawson, (410) 786–
1366, Gaysha Brooks, (410) 786–9649, or
Annette Brewer (410) 786–6580.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
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II. Summary of Errors
A. Summary of Errors in the Preamble
On page 84545 of the CY 2021 PFS
final rule, third column, prior to the first
full paragraph, in our discussion of
clarifications and proposals related to
digitally stored data services/remote
physiologic monitoring/treatment
management services, we inadvertently
deleted, before publication, language
summarizing and responding to two sets
of public comments. We also
inadvertently included language on
page 84545 of the CY 2021 PFS final
rule, third column, the first partial
paragraph at the top of the column.
B. Summary of Errors in the Addenda
On page 85057, in Table B.2.
Audiology, second column, second row,
the entry NQF #/eCQM NQF # contains
a typographical error.
On page 85069, in Table B.5. Clinical
Social Work, second column, second
row, the entry NQF #/eCQM NQF #
contains a typographical error.
On page 85076, in Table B.8.
Diagnostic Radiology, ninth column
entry Measure Steward, third row, we
inadvertently misidentified the measure
steward.
On page 85083, in Table B.10.
Endocrinology, second column, third
row, the entry NQF #/eCQM NQF #
contains a typographical error.
On page 85089, in Table B.11. Family
Medicine, second column, sixth row,
the entry NQF #/eCQM NQF # contains
typographical errors.
On page 85110, in Table B.16.
Infectious Disease, ninth column entry
Measure Steward, fourth row, we
inadvertently misidentified the measure
steward.
On page 85114, in Table B.17. Internal
Medicine, second column, first row, the
entry NQF #/eCQM NQF # contains a
typographical error.
On page 85124, in Table B.19. Mental/
Behavioral Health, second column, fifth
row, the entry NQF #/eCQM NQF #
contains a typographical error.
On page 85130, in Table B.21.
Neurology, second column, third row,
the entry NQF #/eCQM NQF # contains
a typographical error.
On page 85141, in Table B.24.
Obstetrics/Gynecology, third column
entry Quality # sixth row, we
PO 00000
Frm 00144
Fmt 4700
Sfmt 4700
inadvertently omitted the Quality
number.
On page 85146, in Table B.25a.
Oncology/Hematology, third column
entry Quality #, fifth row, we
inadvertently omitted the Quality
number.
On page 85157, in Table B.27.
Orthopedic Surgery, second column,
third row, the entry NQF #/eCQM NQF
# contains a typographical error.
On page 85171, in Table B.30.
Pediatrics, second column, fifth row, the
entry NQF #/eCQM NQF # contains
typographical errors.
On page 85171, in Table B.30.
Pediatrics, ninth column entry Measure
Steward, sixth row, we inadvertently
misidentified the measure steward.
On page 85173, in Table B.30.
Pediatrics, second column, sixth row,
the entry NQF #/eCQM NQF # contains
typographical errors.
On page 85179, in Table B.32.
Physical Therapy/Occupational
Therapy, second column, fifth row, the
entry NQF #/eCQM NQF # contains a
typographical error.
On page 85190, in Table B.35.
Preventive Medicine, second column,
third row, the entry NQF #/eCQM NQF
# contains a typographical error.
On page 85199, in Table B.38. Skilled
Nursing Facility, third column entry
Quality #, fifth row, we inadvertently
omitted the Quality number.
On page 85203, in Table B.39. Speech
Language Pathology, second column,
first row, the entry NQF #/eCQM NQF
# contains a typographical error.
On page 85268, in Table D.26.
Preventive Care and Screening:
Screening for Depression and FollowUp Plan, second column, first row, the
entry NQF #/eCQM NQF # contains a
typographical error.
On page 85333, in Table D.82.
Immunizations for Adolescents, second
column, first row, the entry NQF #/
eCQM NQF # contains a typographical
error.
III. Waiver of Proposed Rulemaking
and Delay in Effective Date
Under 5 U.S.C. 553(b) of the
Administrative Procedure Act (the
APA), the agency is required to publish
a notice of the proposed rule in the
Federal Register before the provisions
of a rule take effect. Similarly, section
1871(b)(1) of the Social Security Act
(the Act) requires the Secretary to
provide for notice of the proposed rule
in the Federal Register and provide a
period of not less than 60 days for
public comment. In addition, section
553(d) of the APA and section
1871(e)(1)(B)(i) of the Act mandate a 30day delay in effective date after issuance
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19JAR1
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Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations
or publication of a rule. Sections
553(b)(B) and 553(d)(3) of the APA
provide for exceptions from the APA
notice and comment, and delay in
effective date requirements; in cases in
which these exceptions apply, sections
1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the
Act provide exceptions from the notice
and 60-day comment period and delay
in effective date requirements of the Act
as well. Section 553(b)(B) of the APA
and section 1871(b)(2)(C) of the Act
authorize an agency to dispense with
normal notice and comment rulemaking
procedures for good cause if the agency
makes a finding that the notice and
comment process is impracticable,
unnecessary, or contrary to the public
interest, and includes a statement of the
finding and the reasons for it in the rule.
In addition, section 553(d)(3) of the
APA and section 1871(e)(1)(B)(ii) allow
the agency to avoid the 30-day delay in
effective date where such delay is
contrary to the public interest and the
agency includes in the rule a statement
of the finding and the reasons for it.
In our view, this correcting document
does not constitute a rulemaking that
would be subject to these requirements.
This document merely corrects
technical errors in the CY 2021 PFS
final rule. The corrections contained in
this document are consistent with, and
do not make substantive changes to, the
policies and payment methodologies
that were proposed, subject to notice
and comment procedures, and adopted
in the CY 2021 PFS final rule. As a
result, the corrections made through this
correcting document are intended to
resolve inadvertent errors so that the CY
2021 PFS final rule accurately reflects
the policies adopted in the final rule.
Even if this were a rulemaking to which
the notice and comment and delayed
effective date requirements applied, we
find that there is good cause to waive
such requirements. Undertaking further
notice and comment procedures to
incorporate the corrections in this
document into the CY 2021 PFS final
rule or delaying the effective date of the
corrections would be contrary to the
public interest because it is in the
public interest to ensure that the rule
accurately reflects our policies as of the
date they take effect. Further, such
procedures would be unnecessary
because we are not making any
substantive revisions to the final rule,
but rather, we are simply correcting the
Federal Register document to reflect the
policies that we previously proposed,
received public comment on, and
subsequently finalized in the CY 2021
PFS final rule. For these reasons, we
believe there is good cause to waive the
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16:33 Jan 17, 2021
Jkt 253001
requirements for notice and comment
and delay in effective date.
IV. Correction of Errors
In FR Doc. 2020–26815 (85 FR 84472),
published December 28, 2020, make the
following corrections:
A. Correction of Errors in the Preamble
1. On page 84545 of the CY 2021 PFS
final rule, third column, the first partial
paragraph at the top of the column is
corrected by removing the following
language:
The medically necessary services
associated with all the medical devices
for a single patient can be billed by only
one practitioner, only once per patient
per 30 day period, and only when at
least 16 days of data have been
collected.
2. On page 84545 of the CY 2021 PFS
final rule, third column, prior to the first
full paragraph, is corrected by adding
the following language:
Comment: Commenters stated that for
CPT codes 99457 and 99458, we
interpreted ‘‘interactive
communication’’ to mean ‘‘real-time
synchronous, two-way audio interaction
that is capable of being enhanced with
video or other kinds of data
transmission’’ and suggested that the
required 20 minutes of time associated
with CPT codes 99457 and 99458
should be only synchronous time, realtime between a practitioner and a
patient. Commenters stated that these
two codes include non-face-to-face time
as well as real-time two-way audio
interactions.
Response: We agree with commenters
that our description of the required 20
minutes of time associated with CPT
codes 99457 and 99458 should include
care management services, as well as
synchronous, real-time interactions.
That is, we agree that ‘‘interactive
communication’’ as we defined it in the
CY 2021 PFS proposed rule contributes
to the total time, but is not the only
activity that should be included in the
total time.
After considering comments, we are
clarifying for purposes of this final rule,
that the 20-minutes of intra-service
work associated with CPT codes 99457
and 99458 includes a practitioner’s time
engaged in ‘‘interactive
communication’’ as well as time
engaged in non-face-to-face care
management services during a calendar
month.
Comment: Commenters disagreed
with our statement that the services
associated with CPT codes 99453 and
99454 should be billed only once per
patient, per 30-day period, and wrote
that CMS should clarify that CPT codes
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Frm 00145
Fmt 4700
Sfmt 4700
5021
99453 and 99454 can be billed once per
provider, per patient, per 30-day period.
Response: We thank commenters for
their insights related to billing CPT
codes 99453 and 99454. As we stated in
the proposed rule, we believe these two
codes should be reported for a patient
only once during a 30-day period and
only when reasonable and necessary. In
response to public commenters, we are
clarifying that only one practitioner can
bill CPT codes 99453 and 99454 during
a 30-day period and only when at least
16 days of data have been collected on
at least one medical device as defined
in section 201(h) of the FFDCA. CPT
language suggests that even when
multiple medical devices are provided
to a patient, the services associated with
all the medical devices can be billed
only once per patient per 30-day period
and only when at least 16 days of data
have been collected. We also note that
when a more specific code is available
to describe a service, CPT indicates that
the more specific code should be billed.
We believe that there are additional,
more specific codes available for billing
that allow remote monitoring (for
example, CPT code 95250 for
continuous glucose monitoring and CPT
codes 99473 and 99474 for selfmeasured blood pressure monitoring).
In summary, we are clarifying that CPT
codes 99453 and 99454 should be
reported only once during a 30-day
period; that even when multiple
medical devices are provided to a
patient, the services associated with all
the medical devices can be billed by
only one practitioner, only once per
patient, per 30-day period, and only
when at least 16 days of data have been
collected; and that the services must be
reasonable and necessary.
B. Correction of Errors in the Addenda
1. On page 85057, in Table B.2.
Audiology, second column, second row,
the NQF #/eCQM NQF # entry ‘‘0418/
0418e’’ is corrected to read ‘‘N/A/
0418e’’.
2. On page 85069, in Table B.5.
Clinical Social Work, second column,
second row, the NQF #/eCQM NQF #
entry ‘‘0418/0418e’’ is corrected to read
‘‘N/A/0418e’’.
3. On page 85076, in Table B.8.
Diagnostic Radiology, ninth column,
third row, the Measure Steward entry
‘‘American College of Radiology/
American Medical AssociationPhysician Consortium for Performance
Improvement/National Committee for
Quality Assurance’’ is corrected to read
‘‘American College of Radiology/
National Committee for Quality
Assurance’’.
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19JAR1
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Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations
4. On page 85083, in Table B.10.
Endocrinology, second column, third
row, the NQF #/eCQM NQF # entry
‘‘0418/0418e’’ is corrected to read ‘‘N/A/
0418e’’.
5. On page 85089, in Table B.11.
Family Medicine, second column, sixth
row, the NQF #/eCQM NQF # entry
‘‘0418/0418e’’ is corrected to read ‘‘N/A/
0418e’’, and in the second column, sixth
row, the NQF #/eCQM NQF # entry
‘‘1407/N/A’’ is corrected to read ‘‘N/A/
N/A’’.
6. On page 85110, in Table B.16.
Infectious Disease, the ninth column,
fourth row, the Measure Steward entry
‘‘Health Resources and Services
Administration’’ is corrected to read
‘‘National Committee for Quality
Assurance’’.
7. On page 85114, in Table B.17.
Internal Medicine, second column, first
row, the NQF #/eCQM NQF # entry
‘‘0418/0418e’’ is corrected to read ‘‘N/A/
0418e’’.
8. On page 85124, in Table B.19.
Mental/Behavioral Health, second
column, fifth row, the NQF #/eCQM
NQF # entry ‘‘0418/0418e’’ is corrected
to read ‘‘N/A/0418e’’.
9. On page 85130, in Table B.21.
Neurology, second column, third row,
the NQF #/eCQM NQF # entry ‘‘0418/
0418e’’ is corrected to read ‘‘N/A/
0418e’’.
10. On page 85141, in Table B.24.
Obstetrics/Gynecology, third column,
fifth row, the blank Quality # entry is
corrected to read ‘‘111’’.
11. On page 85146, in Table B.25a.
Oncology/Hematology, third column,
fifth row, the blank Quality # entry is
corrected to read ‘‘110’’.
12. On page 85157, in Table B.27.
Orthopedic Surgery, second column,
third row, the NQF #/eCQM NQF #
entry ‘‘0418/0418e’’ is corrected to read
‘‘N/A/0418e’’.
13. On page 85171, in Table B.30.
Pediatrics, second column, fifth row, the
NQF #/eCQM NQF # entry ‘‘0418/
0418e’’ is corrected to read ‘‘N/A/
0418e’’.
14. On page 85171, in Table B.30.
Pediatrics, ninth column, sixth row, the
Measure Steward entry ‘‘Health
Resources and Services Administration’’
is corrected to read ‘‘National
Committee for Quality Assurance’’.
15. On page 85173, in Table B.30.
Pediatrics, second column, sixth row,
the NQF #/eCQM NQF # entry ‘‘1407/
N/A’’ is corrected to read ‘‘N/A/N/A’’.
16. On page 85179, in Table B.32.
Physical Therapy/Occupational
Therapy, second column, fifth row, the
NQF #/eCQM NQF # entry ‘‘0418/
0418e’’ is corrected to read ‘‘N/A/
0418e’’.
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16:33 Jan 17, 2021
Jkt 253001
17. On page 85190, in Table B.35.
Preventive Medicine, second column,
third row, the NQF #/eCQM NQF #
‘‘entry 0418/0418e’’ is corrected to read
‘‘N/A/0418e’’.
18. On page 85199, in Table B.38.
Skilled Nursing Facility, third column,
fifth row, the blank Quality # entry is
corrected to read ‘‘110’’.
19. On page 85203, in Table B.39.
Speech Language Pathology, second
column, first row, the NQF #/eCQM
NQF # entry ‘‘0418/0418e’’ is corrected
to read ‘‘N/A/0418e’’.
20. On page 85268, in Table D.26.
Preventive Care and Screening:
Screening for Depression and FollowUp Plan, second column, first row, the
NQF #/eCQM NQF # entry ‘‘0418/
0418e’’ is corrected to read ‘‘N/A/
0418e’’.
21. On page 85333, in Table D.82.
Immunizations for Adolescents, second
column, first row, the NQF #/eCQM
NQF # entry ‘‘1407/N/A’’ is corrected to
read ‘‘N/A/N/A’’.
Dated: January 11, 2021.
Wilma M. Robinson,
Deputy Executive Secretary to the
Department, Department of Health and
Human Services.
[FR Doc. 2021–00805 Filed 1–14–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2020–0215]
RIN 1625–AC26
Certificate of Documentation—5 Year
Renewal Fees
Coast Guard, DHS.
Final rule.
AGENCY:
The Coast Guard is issuing a
final rule extending the validity of a
recreational vessel endorsement on a
Certificate of Documentation (COD)
from 1 to 5 years. Congress passed and
the President signed the Frank
LoBiondo Coast Guard Authorization
Act of 2018, which requires the Coast
Guard to issue recreational vessel CODs
for 5 years. By updating the Code of
Federal Regulations to reflect this
change, the Coast Guard anticipates this
final rule to harmonize with the
requirements of the 2018 Act that
decreased the burden on recreational
vessel owners by requiring COD
renewals every 5 years rather than
annually.
SUMMARY:
PO 00000
Frm 00146
Fmt 4700
To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2020–
0215 in the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rule.
ADDRESSES:
For
information about this document, call or
email Mr. Ronald Teague, Department of
Homeland Security, U.S. Coast Guard,
National Vessel Documentation Center,
792 T J Jackson Drive, Falling Waters,
WV 25419; telephone 304 271–2506;
email ronald.s.teague@uscg.mil.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Table of Contents for Preamble
I. Abbreviations
II. Basis and Purpose, and Regulatory History
III. Background
IV. Discussion of the Rule
V. Regulatory Analyses
A. Regulatory Planning and Review
B. Small Entities
C. Assistance for Small Entities
D. Collection of Information
E. Federalism
F. Unfunded Mandates
G. Taking of Private Property
H. Civil Justice Reform
I. Protection of Children
J. Indian Tribal Governments
K. Energy Effects
L. Technical Standards
M. Environment
I. Abbreviations
46 CFR Part 67
ACTION:
This final rule is effective
February 18, 2021.
DATES:
Sfmt 4700
2018 Act Frank LoBiondo Coast Guard
Authorization Act of 2018 (Pub. L. 115–
282, 132 Stat. 4192)
BLS Bureau of Labor Statistics
CFR Code of Federal Regulations
COD Certificate of Documentation
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
NVDC U.S. Coast Guard National Vessel
Documentation Center
OMB Office of Management and Budget
§ Section
SME Subject matter expert
U.S.C. United States Code
II. Basis and Purpose, and Regulatory
History
The legal basis for this final rule is
found in Section 512 of the Frank
LoBiondo Coast Guard Authorization
Act of 2018 (2018 Act) (Pub. L. 115–282,
132 Stat. 4192) (the 2018 Act), which
the President signed on December 4,
2018. The 2018 Act directed the Coast
Guard to do the following: (1) Make
Certificates of Documentation (CODs)
for recreational vessels of at least five
E:\FR\FM\19JAR1.SGM
19JAR1
]]>Agencies
[Federal Register Volume 86, Number 11 (Tuesday, January 19, 2021)]
[Rules and Regulations]
[Pages 5020-5022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00805]
[[Page 5020]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 400, 410, 414, 415, 423, 424, and 425
[CMS-1734-F, CMS-1734-IFC, CMS-1744-F, CMS-5531-F and CMS-3401-IFC] CN
RIN 0938-AU10, 0938-AU31, 0938-AU32, and 0938-AU33
Medicare Program; CY 2021 Payment Policies Under the Physician
Fee Schedule and Other Changes to Part B Payment Policies; Medicare
Shared Savings Program Requirements; Medicaid Promoting
Interoperability Program Requirements for Eligible Professionals;
Quality Payment Program; Coverage of Opioid Use Disorder Services
Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid
Treatment Programs; Electronic Prescribing for Controlled Substances
for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and
Management Services; Hospital IQR Program; Establish New Code
Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model
Emergency Policy; Coding and Payment for Virtual Check-In Services
Interim Final Rule Policy; Coding and Payment for Personal Protective
Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in
Response to the Public Health Emergency (PHE) for COVID-19; and
Finalization of Certain Provisions From the March 31st, May 8th and
September 2nd Interim Final Rules in Response to the PHE for COVID-19;
Correction
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule and interim final rule; Correction.
-----------------------------------------------------------------------
SUMMARY: This document corrects technical errors in the final rule that
appeared in the December 28, 2020, Federal Register under the same as
title above. Hereinafter, the December 28 rule is referred to as the CY
2021 PFS final rule.
DATES: This correction is effective January 19, 2021, and is applicable
beginning January 1, 2021.
FOR FURTHER INFORMATION CONTACT: Cynthia Lambert-Lawson, (410) 786-
1366, Gaysha Brooks, (410) 786-9649, or Annette Brewer (410) 786-6580.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc. 2020-26815 of December 28, 2020, the CY 2021 PFS final
rule (85 FR 84472), there were technical errors that are identified and
corrected in this correcting document. These corrections are effective
and applicable beginning January 1, 2021.
II. Summary of Errors
A. Summary of Errors in the Preamble
On page 84545 of the CY 2021 PFS final rule, third column, prior to
the first full paragraph, in our discussion of clarifications and
proposals related to digitally stored data services/remote physiologic
monitoring/treatment management services, we inadvertently deleted,
before publication, language summarizing and responding to two sets of
public comments. We also inadvertently included language on page 84545
of the CY 2021 PFS final rule, third column, the first partial
paragraph at the top of the column.
B. Summary of Errors in the Addenda
On page 85057, in Table B.2. Audiology, second column, second row,
the entry NQF #/eCQM NQF # contains a typographical error.
On page 85069, in Table B.5. Clinical Social Work, second column,
second row, the entry NQF #/eCQM NQF # contains a typographical error.
On page 85076, in Table B.8. Diagnostic Radiology, ninth column
entry Measure Steward, third row, we inadvertently misidentified the
measure steward.
On page 85083, in Table B.10. Endocrinology, second column, third
row, the entry NQF #/eCQM NQF # contains a typographical error.
On page 85089, in Table B.11. Family Medicine, second column, sixth
row, the entry NQF #/eCQM NQF # contains typographical errors.
On page 85110, in Table B.16. Infectious Disease, ninth column
entry Measure Steward, fourth row, we inadvertently misidentified the
measure steward.
On page 85114, in Table B.17. Internal Medicine, second column,
first row, the entry NQF #/eCQM NQF # contains a typographical error.
On page 85124, in Table B.19. Mental/Behavioral Health, second
column, fifth row, the entry NQF #/eCQM NQF # contains a typographical
error.
On page 85130, in Table B.21. Neurology, second column, third row,
the entry NQF #/eCQM NQF # contains a typographical error.
On page 85141, in Table B.24. Obstetrics/Gynecology, third column
entry Quality # sixth row, we inadvertently omitted the Quality number.
On page 85146, in Table B.25a. Oncology/Hematology, third column
entry Quality #, fifth row, we inadvertently omitted the Quality
number.
On page 85157, in Table B.27. Orthopedic Surgery, second column,
third row, the entry NQF #/eCQM NQF # contains a typographical error.
On page 85171, in Table B.30. Pediatrics, second column, fifth row,
the entry NQF #/eCQM NQF # contains typographical errors.
On page 85171, in Table B.30. Pediatrics, ninth column entry
Measure Steward, sixth row, we inadvertently misidentified the measure
steward.
On page 85173, in Table B.30. Pediatrics, second column, sixth row,
the entry NQF #/eCQM NQF # contains typographical errors.
On page 85179, in Table B.32. Physical Therapy/Occupational
Therapy, second column, fifth row, the entry NQF #/eCQM NQF # contains
a typographical error.
On page 85190, in Table B.35. Preventive Medicine, second column,
third row, the entry NQF #/eCQM NQF # contains a typographical error.
On page 85199, in Table B.38. Skilled Nursing Facility, third
column entry Quality #, fifth row, we inadvertently omitted the Quality
number.
On page 85203, in Table B.39. Speech Language Pathology, second
column, first row, the entry NQF #/eCQM NQF # contains a typographical
error.
On page 85268, in Table D.26. Preventive Care and Screening:
Screening for Depression and Follow-Up Plan, second column, first row,
the entry NQF #/eCQM NQF # contains a typographical error.
On page 85333, in Table D.82. Immunizations for Adolescents, second
column, first row, the entry NQF #/eCQM NQF # contains a typographical
error.
III. Waiver of Proposed Rulemaking and Delay in Effective Date
Under 5 U.S.C. 553(b) of the Administrative Procedure Act (the
APA), the agency is required to publish a notice of the proposed rule
in the Federal Register before the provisions of a rule take effect.
Similarly, section 1871(b)(1) of the Social Security Act (the Act)
requires the Secretary to provide for notice of the proposed rule in
the Federal Register and provide a period of not less than 60 days for
public comment. In addition, section 553(d) of the APA and section
1871(e)(1)(B)(i) of the Act mandate a 30-day delay in effective date
after issuance
[[Page 5021]]
or publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA
provide for exceptions from the APA notice and comment, and delay in
effective date requirements; in cases in which these exceptions apply,
sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide
exceptions from the notice and 60-day comment period and delay in
effective date requirements of the Act as well. Section 553(b)(B) of
the APA and section 1871(b)(2)(C) of the Act authorize an agency to
dispense with normal notice and comment rulemaking procedures for good
cause if the agency makes a finding that the notice and comment process
is impracticable, unnecessary, or contrary to the public interest, and
includes a statement of the finding and the reasons for it in the rule.
In addition, section 553(d)(3) of the APA and section 1871(e)(1)(B)(ii)
allow the agency to avoid the 30-day delay in effective date where such
delay is contrary to the public interest and the agency includes in the
rule a statement of the finding and the reasons for it.
In our view, this correcting document does not constitute a
rulemaking that would be subject to these requirements. This document
merely corrects technical errors in the CY 2021 PFS final rule. The
corrections contained in this document are consistent with, and do not
make substantive changes to, the policies and payment methodologies
that were proposed, subject to notice and comment procedures, and
adopted in the CY 2021 PFS final rule. As a result, the corrections
made through this correcting document are intended to resolve
inadvertent errors so that the CY 2021 PFS final rule accurately
reflects the policies adopted in the final rule. Even if this were a
rulemaking to which the notice and comment and delayed effective date
requirements applied, we find that there is good cause to waive such
requirements. Undertaking further notice and comment procedures to
incorporate the corrections in this document into the CY 2021 PFS final
rule or delaying the effective date of the corrections would be
contrary to the public interest because it is in the public interest to
ensure that the rule accurately reflects our policies as of the date
they take effect. Further, such procedures would be unnecessary because
we are not making any substantive revisions to the final rule, but
rather, we are simply correcting the Federal Register document to
reflect the policies that we previously proposed, received public
comment on, and subsequently finalized in the CY 2021 PFS final rule.
For these reasons, we believe there is good cause to waive the
requirements for notice and comment and delay in effective date.
IV. Correction of Errors
In FR Doc. 2020-26815 (85 FR 84472), published December 28, 2020,
make the following corrections:
A. Correction of Errors in the Preamble
1. On page 84545 of the CY 2021 PFS final rule, third column, the
first partial paragraph at the top of the column is corrected by
removing the following language:
The medically necessary services associated with all the medical
devices for a single patient can be billed by only one practitioner,
only once per patient per 30 day period, and only when at least 16 days
of data have been collected.
2. On page 84545 of the CY 2021 PFS final rule, third column, prior
to the first full paragraph, is corrected by adding the following
language:
Comment: Commenters stated that for CPT codes 99457 and 99458, we
interpreted ``interactive communication'' to mean ``real-time
synchronous, two-way audio interaction that is capable of being
enhanced with video or other kinds of data transmission'' and suggested
that the required 20 minutes of time associated with CPT codes 99457
and 99458 should be only synchronous time, real-time between a
practitioner and a patient. Commenters stated that these two codes
include non-face-to-face time as well as real-time two-way audio
interactions.
Response: We agree with commenters that our description of the
required 20 minutes of time associated with CPT codes 99457 and 99458
should include care management services, as well as synchronous, real-
time interactions. That is, we agree that ``interactive communication''
as we defined it in the CY 2021 PFS proposed rule contributes to the
total time, but is not the only activity that should be included in the
total time.
After considering comments, we are clarifying for purposes of this
final rule, that the 20-minutes of intra-service work associated with
CPT codes 99457 and 99458 includes a practitioner's time engaged in
``interactive communication'' as well as time engaged in non-face-to-
face care management services during a calendar month.
Comment: Commenters disagreed with our statement that the services
associated with CPT codes 99453 and 99454 should be billed only once
per patient, per 30-day period, and wrote that CMS should clarify that
CPT codes 99453 and 99454 can be billed once per provider, per patient,
per 30-day period.
Response: We thank commenters for their insights related to billing
CPT codes 99453 and 99454. As we stated in the proposed rule, we
believe these two codes should be reported for a patient only once
during a 30-day period and only when reasonable and necessary. In
response to public commenters, we are clarifying that only one
practitioner can bill CPT codes 99453 and 99454 during a 30-day period
and only when at least 16 days of data have been collected on at least
one medical device as defined in section 201(h) of the FFDCA. CPT
language suggests that even when multiple medical devices are provided
to a patient, the services associated with all the medical devices can
be billed only once per patient per 30-day period and only when at
least 16 days of data have been collected. We also note that when a
more specific code is available to describe a service, CPT indicates
that the more specific code should be billed. We believe that there are
additional, more specific codes available for billing that allow remote
monitoring (for example, CPT code 95250 for continuous glucose
monitoring and CPT codes 99473 and 99474 for self-measured blood
pressure monitoring). In summary, we are clarifying that CPT codes
99453 and 99454 should be reported only once during a 30-day period;
that even when multiple medical devices are provided to a patient, the
services associated with all the medical devices can be billed by only
one practitioner, only once per patient, per 30-day period, and only
when at least 16 days of data have been collected; and that the
services must be reasonable and necessary.
B. Correction of Errors in the Addenda
1. On page 85057, in Table B.2. Audiology, second column, second
row, the NQF #/eCQM NQF # entry ``0418/0418e'' is corrected to read
``N/A/0418e''.
2. On page 85069, in Table B.5. Clinical Social Work, second
column, second row, the NQF #/eCQM NQF # entry ``0418/0418e'' is
corrected to read ``N/A/0418e''.
3. On page 85076, in Table B.8. Diagnostic Radiology, ninth column,
third row, the Measure Steward entry ``American College of Radiology/
American Medical Association-Physician Consortium for Performance
Improvement/National Committee for Quality Assurance'' is corrected to
read ``American College of Radiology/National Committee for Quality
Assurance''.
[[Page 5022]]
4. On page 85083, in Table B.10. Endocrinology, second column,
third row, the NQF #/eCQM NQF # entry ``0418/0418e'' is corrected to
read ``N/A/0418e''.
5. On page 85089, in Table B.11. Family Medicine, second column,
sixth row, the NQF #/eCQM NQF # entry ``0418/0418e'' is corrected to
read ``N/A/0418e'', and in the second column, sixth row, the NQF #/eCQM
NQF # entry ``1407/N/A'' is corrected to read ``N/A/N/A''.
6. On page 85110, in Table B.16. Infectious Disease, the ninth
column, fourth row, the Measure Steward entry ``Health Resources and
Services Administration'' is corrected to read ``National Committee for
Quality Assurance''.
7. On page 85114, in Table B.17. Internal Medicine, second column,
first row, the NQF #/eCQM NQF # entry ``0418/0418e'' is corrected to
read ``N/A/0418e''.
8. On page 85124, in Table B.19. Mental/Behavioral Health, second
column, fifth row, the NQF #/eCQM NQF # entry ``0418/0418e'' is
corrected to read ``N/A/0418e''.
9. On page 85130, in Table B.21. Neurology, second column, third
row, the NQF #/eCQM NQF # entry ``0418/0418e'' is corrected to read
``N/A/0418e''.
10. On page 85141, in Table B.24. Obstetrics/Gynecology, third
column, fifth row, the blank Quality # entry is corrected to read
``111''.
11. On page 85146, in Table B.25a. Oncology/Hematology, third
column, fifth row, the blank Quality # entry is corrected to read
``110''.
12. On page 85157, in Table B.27. Orthopedic Surgery, second
column, third row, the NQF #/eCQM NQF # entry ``0418/0418e'' is
corrected to read ``N/A/0418e''.
13. On page 85171, in Table B.30. Pediatrics, second column, fifth
row, the NQF #/eCQM NQF # entry ``0418/0418e'' is corrected to read
``N/A/0418e''.
14. On page 85171, in Table B.30. Pediatrics, ninth column, sixth
row, the Measure Steward entry ``Health Resources and Services
Administration'' is corrected to read ``National Committee for Quality
Assurance''.
15. On page 85173, in Table B.30. Pediatrics, second column, sixth
row, the NQF #/eCQM NQF # entry ``1407/N/A'' is corrected to read ``N/
A/N/A''.
16. On page 85179, in Table B.32. Physical Therapy/Occupational
Therapy, second column, fifth row, the NQF #/eCQM NQF # entry ``0418/
0418e'' is corrected to read ``N/A/0418e''.
17. On page 85190, in Table B.35. Preventive Medicine, second
column, third row, the NQF #/eCQM NQF # ``entry 0418/0418e'' is
corrected to read ``N/A/0418e''.
18. On page 85199, in Table B.38. Skilled Nursing Facility, third
column, fifth row, the blank Quality # entry is corrected to read
``110''.
19. On page 85203, in Table B.39. Speech Language Pathology, second
column, first row, the NQF #/eCQM NQF # entry ``0418/0418e'' is
corrected to read ``N/A/0418e''.
20. On page 85268, in Table D.26. Preventive Care and Screening:
Screening for Depression and Follow-Up Plan, second column, first row,
the NQF #/eCQM NQF # entry ``0418/0418e'' is corrected to read ``N/A/
0418e''.
21. On page 85333, in Table D.82. Immunizations for Adolescents,
second column, first row, the NQF #/eCQM NQF # entry ``1407/N/A'' is
corrected to read ``N/A/N/A''.
Dated: January 11, 2021.
Wilma M. Robinson,
Deputy Executive Secretary to the Department, Department of Health and
Human Services.
[FR Doc. 2021-00805 Filed 1-14-21; 8:45 am]
BILLING CODE 4120-01-P
