Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program; Correction

Published date30 November 2021
Citation86 FR 67874
Record Number2021-26069
SectionRules and Regulations
CourtCenters For Medicare & Medicaid Services
67874
Federal Register / Vol. 86, No. 227 / Tuesday, November 30, 2021 / Rules and Regulations
T
EXAS
—2015 8-H
OUR
O
ZONE
NAAQS
[Primary and secondary]
Designated area
1
Designation Classification
Date
2
Type Date
2
Type
*******
El Paso-Las Cruces, TX–NM ............................................................................................. .............................. Nonattainment ...... Marginal.
El Paso County ........................................................................................................... December 30, 2021
3
.
*******
1
Includes any Indian country in each county or area, unless otherwise specified. EPA is not determining the boundaries of any area of Indian country in this table,
including any area of Indian country located in the larger designation area. The inclusion of any Indian country in the designation area is not a determination that the
state has regulatory authority under the Clean Air Act for such Indian country.
2
This date is August 3, 2018, unless otherwise noted.
3
EPA revised the nonattainment boundary in response to a court decision, which did not vacate any designations for the 2015 ozone NAAQS, but which remanded
the designation for the identified county. Because this additional area is part of a previously designated nonattainment area, the associated August 3, 2021 attainment
date remains unchanged regardless of this later designation date. EPA established a later state implementation plan submission date for El Paso County.
* * * * *
[FR Doc. 2021–25451 Filed 11–29–21; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 413
[CMS–1752–CN2 and CMS–1762–CN2]
RINs 0938–AU44 and 0938–AU56
Medicare Program; Hospital Inpatient
Prospective Payment Systems for
Acute Care Hospitals and the Long-
Term Care Hospital Prospective
Payment System and Policy Changes
and Fiscal Year 2022 Rates; Quality
Programs and Medicare Promoting
Interoperability Program Requirements
for Eligible Hospitals and Critical
Access Hospitals; Changes to
Medicaid Provider Enrollment; and
Changes to the Medicare Shared
Savings Program; Correction
AGENCY
: Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION
: Final rule; correction.
SUMMARY
: This document corrects
typographical errors in the final rule
that appeared in the August 13, 2021,
Federal Register as well as additional
typographical errors in a related
correcting amendment that appeared in
the October 20, 2021, Federal Register.
The final rule was titled ‘‘Medicare
Program; Hospital Inpatient Prospective
Payment Systems for Acute Care
Hospitals and the Long Term Care
Hospital Prospective Payment System
and Policy Changes and Fiscal Year
2022 Rates; Quality Programs and
Medicare Promoting Interoperability
Program Requirements for Eligible
Hospitals and Critical Access Hospitals;
Changes to Medicaid Provider
Enrollment; and Changes to the
Medicare Shared Savings Program’’.
DATES
:
Effective date: This correcting
document is effective on November 29,
2021.
Applicability date: This correcting
document is applicable for discharges
beginning October 1, 2021.
FOR FURTHER INFORMATION CONTACT
:
Allison Pompey, (410) 786–2348, New
Technology Add-On Payment Issues.
SUPPLEMENTARY INFORMATION
:
I. Background
In the final rule which appeared in
the August 13, 2021, Federal Register
(86 FR 44774) entitled ‘‘Medicare
Program; Hospital Inpatient Prospective
Payment Systems for Acute Care
Hospitals and the Long Term Care
Hospital Prospective Payment System
and Policy Changes and Fiscal Year
2022 Rates; Quality Programs and
Medicare Promoting Interoperability
Program Requirements for Eligible
Hospitals and Critical Access Hospitals;
Changes to Medicaid Provider
Enrollment; and Changes to the
Medicare Shared Savings Program’’
(hereinafter referred to as the FY 2022
IPPS/LTCH PPS final rule), there were
a number of technical and typographical
errors. To correct the typographical and
technical errors in the FY 2022 IPPS/
LTCH PPS final rule, we published a
correcting document that appeared in
the October 20, 2021, Federal Register
(86 FR 58019) (hereinafter referred to as
the FY 2022 IPPS/LTCH PPS correcting
amendment).
In FR Doc. 2021–22724 of October 20,
2021 (86 FR 58019), there was an
inadvertent omission and typographical
error that are identified and corrected in
this correcting document. This
document also corrects additional
typographical errors in FR Doc. 2021–
16519 of August 13, 2021 (86 FR 44774).
The corrections in this correcting
document are applicable to discharges
occurring on or after October 1, 2021, as
if they had been included in the
document that appeared in the August
13, 2021, Federal Register .
II. Summary of Errors
A. Summary of Errors in the FY 2022
IPPS/LTCH PPS Final Rule
On page 44974, in the table displaying
the continuation of technologies
approved for FY 2021 new technology
add-on payments and still considered
new for FY 2022, we are correcting
inadvertent typographical errors in the
coding used to identify cases involving
the use of the BAROSTIM NEO
TM
System that are eligible for new
technology add-on payments.
B. Summary of Errors in the FY 2022
IPPS/LTCH PPS Correcting Document
On page 58023 in section IV.A. of the
FY 2022 IPPS/LTCH PPS correcting
amendment, we inadvertently omitted
corrections to pages 45133, 45150, and
45157 of the FY 2022 IPPS/LTCH PPS
final rule, as summarized on page 58019
in section II.A. of the FY 2022 IPPS/
LTCH PPS correcting amendment. We
are also correcting an inadvertent
typographical error in the coding used
to identify cases involving the use of
RECARBRIO
TM
that are eligible for new
technology add-on payments.
III. Waiver of Proposed Rulemaking
and Delay in Effective Date
Under 5 U.S.C. 553(b) of the
Administrative Procedure Act (APA),
the agency is required to publish a
notice of the proposed rulemaking in
the Federal Register before the
provisions of a rule take effect.
Similarly, section 1871(b)(1) of the Act
requires the Secretary to provide for
notice of the proposed rulemaking in
the Federal Register and provide a
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Federal Register / Vol. 86, No. 227 / Tuesday, November 30, 2021 / Rules and Regulations
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
or publication of a rule. Sections
553(b)(B) and 553(d)(3) of the APA
provide for exceptions from the notice
and comment and delay in effective date
APA 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 rulemaking requirements for
good cause if the agency makes a
finding that the notice and comment
process are impracticable, unnecessary,
or contrary to the public interest. In
addition, both section 553(d)(3) of the
APA and section 1871(e)(1)(B)(ii) of the
Act allow the agency to avoid the 30-
day delay in effective date where such
delay is contrary to the public interest
and an agency includes a statement of
support.
We believe that this final rule
correction does not constitute a rule that
would be subject to the notice and
comment or delayed effective date
requirements. This document corrects
typographical errors in the FY 2022
IPPS/LTCH PPS final rule and the FY
2022 IPPS/LTCH PPS final rule
correcting amendment, but does not
make substantive changes to the policies
or payment methodologies that were
adopted in the final rule. As a result,
this final rule correction is intended to
ensure that the information in the FY
2022 IPPS/LTCH PPS final rule
accurately reflects the policies adopted
in that document.
In addition, even if this were a rule to
which the notice and comment
procedures 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 final rule or delaying
the effective date would be contrary to
the public interest because it is in the
public’s interest for providers to receive
appropriate payments in as timely a
manner as possible, and to ensure that
the FY 2022 IPPS/LTCH PPS final rule
accurately reflects our policies.
Furthermore, such procedures would be
unnecessary, as we are not altering our
payment methodologies or policies, but
rather, we are simply implementing
correctly the methodologies and policies
that we previously proposed, requested
comment on, and subsequently
finalized. This final rule correction is
intended solely to ensure that the FY
2022 IPPS/LTCH PPS final rule
accurately reflects these payment
methodologies and policies. Therefore,
we believe we have good cause to waive
the notice and comment and effective
date requirements. Moreover, even if
these corrections were considered to be
retroactive rulemaking, they would be
authorized under section
1871(e)(1)(A)(ii) of the Act, which
permits the Secretary to issue a rule for
the Medicare program with retroactive
effect if the failure to do so would be
contrary to the public interest. As we
have explained previously, we believe it
would be contrary to the public interest
not to implement the corrections in this
final rule correction because it is in the
public’s interest for providers to receive
appropriate payments in as timely a
manner as possible, and to ensure that
the FY 2022 IPPS/LTCH PPS final rule
accurately reflects our policies.
IV. Correction of Errors
A. Correction of Errors in the Final Rule
In FR Doc. 2021–16519 of August 13,
2021(86 FR 44774), we are making the
following corrections:
1. On page 44974, in the table titled
‘‘Continuation of Technologies
Approved for FY 2021 New Technology
Add-On Payments and Still Considered
New for FY 2022, the entry in row 3 is
corrected to read as follows:
B. Correction of Errors in the Correcting
Document
In FR Doc. 2021–22724 of October 20,
2021 (86 FR 58019), we are making the
following corrections:
1. On page 58023, lower half of the
page (following the table), third column:
a. Preceding the beginning of the
partial paragraph (before item 10), the
paragraph is corrected by adding items
7 through 9 to read as follows:
‘‘7. On page 45133, top of the page,
a. First column, partial paragraph,
(1) Line 4, the figure ‘‘$31,500’’ is
corrected to read ‘‘$63,000’’.
(2) Line 5, the figure ‘‘$10,500’’ is
corrected to read ‘‘$21,000’’.
b. Second column, partial paragraph,
last line, the figure ‘‘$20,475’’ is
corrected to read ‘‘$40,950’’.
8. On page 45150, second column, last
full paragraph, lines 27 through 31, the
phrase ‘‘in combination with one of the
following ICD–10–CM codes: D65
(Disseminated intravascular
coagulation) or D68.2 (Hereditary
deficiency of other clotting factors).’’ is
corrected to read ‘‘in combination with
one of the following ICD–10–CM codes:
D62 (Acute posthemorrhagic anemia),
D65 (Disseminated intravascular
coagulation), D68.2 (Hereditary
deficiency of other clotting factors),
D68.4 (Acquired coagulation factor
deficiency) or D68.9 (Coagulation
defect, unspecified).’’.
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ER30NO21.045</GPH>
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FDA Maximum
Technology Newness/Start NTAP NTAP Status Previous Final NTAP Coding Used to Identify
Start Date for FY 2022 Rule Citations Amount for Cases Eligible for NTAP
Date
FY2022
*******
Continue
because 3-year
BAROSTIM
anniversary 0JH60MZ in combination
3.
NED™
08/16/2019 10/01/2020 date (85
FR
58716 $22,750 with 03HK3MZ or
System (8/16/2022) through 58717) 03HL3MZ
will occur in
the second
half
ofFY2022
*******
67876
Federal Register / Vol. 86, No. 227 / Tuesday, November 30, 2021 / Rules and Regulations
9. On page 45157, top third of the
page, first column, first partial
paragraph, last line, the phrase,
‘‘technology group 6).’’ is corrected to
read ‘‘technology group 6) in
combination with the following ICD–
10–CM codes: Y95 (Nosocomial
condition) and one of the following: J14
(Pneumonia due to Hemophilus
influenzae) J15.0 (Pneumonia due to
Klebsiella pneumoniae), J15.1
(Pneumonia due to Pseudomonas), J15.5
(Pneumonia due to Escherichia coli),
J15.6 (Pneumonia due to other Gram-
negative bacteria), J15.8 (Pneumonia
due to other specified bacteria), or
J95.851 (Ventilator associated
pneumonia) and one of the following:
B96.1 (Klebsiella pneumoniae [K.
pneumoniae] as the cause of diseases
classified elsewhere), B96.20
(Unspecified Escherichia coli [E. coli] as
the cause of diseases classified
elsewhere), B96.21 (Shiga toxin-
producing Escherichia coli [E. coli]
[STEC] O157 as the cause of diseases
classified elsewhere), B96.22 (Other
specified Shiga toxin-producing
Escherichia coli [E. coli] [STEC] as the
cause of diseases classified elsewhere),
B96.23 (Unspecified Shiga toxin-
producing Escherichia coli [E. coli]
[STEC] as the cause of diseases
classified elsewhere, B96.29 (Other
Escherichia coli [E. coli] as the cause of
diseases classified elsewhere), B96.3
(Hemophilus influenzae [H. influenzae]
as the cause of diseases classified
elsewhere, B96.5 (Pseudomonas
(aeruginosa) (mallei) (pseudomallei) as
the cause of diseases classified
elsewhere), or B96.89 (Other specified
bacterial agents as the cause of diseases
classified elsewhere).’’
b. Within the partial paragraph (item
10), line 8, the code number ‘‘J14.0’’ is
corrected to read ‘‘J14’’.
Karuna Seshasai,
Executive Secretary to the Department,
Department of Health and Human Services.
[FR Doc. 2021–26069 Filed 11–29–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF DEFENSE
Defense Acquisition Regulations
System
48 CFR Parts 201 and 237
[Docket DARS–2021–0023]
RIN 0750–AK77
Defense Federal Acquisition
Regulation Supplement: Peer Reviews
of Contracts for Supplies and Services
(DFARS Case 2019–D037)
AGENCY
: Defense Acquisition
Regulations System, Department of
Defense (DoD).
ACTION
: Final rule.
SUMMARY
: DoD is issuing a final rule
amending the Defense Federal
Acquisition Regulation Supplement
(DFARS) to modify internal processes
for the conduct of peer reviews.
DATES
: Effective November 30, 2021.
FOR FURTHER INFORMATION CONTACT
: Ms.
Barbara J. Trujillo, telephone 571–372–
6102.
SUPPLEMENTARY INFORMATION
:
I. Background
DoD is amending the DFARS to revise
the policies at DFARS 201.170 for the
conduct of peer reviews by the Office of
the Principal Director, Defense Pricing
and Contracting (DPC). The rule
removes the requirement for DPC-led,
preaward peer reviews of competitive
procurements valued at $1 billion or
more unless the Under Secretary of
Defense for Acquisition and
Sustainment (USD(A&S)) is the
milestone decision authority or unless
USD(A&S) designates a competitive
procurement as requiring a peer review,
regardless of dollar value. Additionally,
DoD components may request DPC-led
peer reviews for competitive
acquisitions valued below the $1 billion
threshold. DPC will conduct the reviews
upon approval by the Director, DPC
(Contract Policy).
The threshold for DPC-led, preaward
peer reviews of noncompetitive
procurements is increased from $500
million to $1 billion. Additionally, the
requirement for DPC-led peer reviews of
noncompetitive procurements will
include any other contract actions
USD(A&S) designates as requiring a peer
review, regardless of dollar value. DoD
components may request DPC-led peer
reviews for noncompetitive acquisitions
valued below the $1 billion threshold.
DPC will conduct the reviews upon
approval by the Director, DPC (Price,
Cost and Finance).
The rule includes clarification of the
types of contract actions included in
preaward peer reviews for
noncompetitive procurements and
guidance on how to identify the contract
actions that are subject to preaward peer
reviews for competitive and
noncompetitive procurements. DoD
components establish procedures to
conduct preaward peer reviews of
competitive and noncompetitive
procurements that do not meet the
criteria for a DPC-led review. The rule
also removes DPC-led, postaward peer
reviews of acquisitions for services from
the DFARS, and the cross-reference at
DFARS 237.102–76 has been removed.
II. Publication of This Final Rule for
Public Comment Is Not Required by
Statute
The statute that applies to the
publication of the Federal Acquisition
Regulation (FAR) is 41 U.S.C. 1707,
Publication of Proposed Regulations.
Subsection (a)(1) of the statute requires
that a procurement policy, regulation,
procedure or form (including an
amendment or modification thereof)
must be published for public comment
if it relates to the expenditure of
appropriated funds, and has either a
significant effect beyond the internal
operating procedures of the agency
issuing the policy, regulation, procedure
or form, or has a significant cost or
administrative impact on contractors or
offerors. This final rule is not required
to be published for public comment,
because the rule concerns DoD’s
internal review processes and does not
have a significant cost or administrative
impact on contractors or offerors.
III. Applicability to Contracts at or
Below the Simplified Acquisition
Threshold and for Commercial Items,
Including Commercially Available Off-
the-Shelf Items
This rule does not create or revise any
solicitation provisions or contract
clauses. It does not impact any existing
solicitation provisions or contract
clauses or their applicability to
contracts valued at or below the
simplified acquisition threshold or for
commercial items, including
commercially available off-the-shelf
items.
IV. Executive Orders 12866 and 13563
Executive Orders (E.O.) 12866 and
E.O. 13563 direct agencies to assess all
costs and benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
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