[Federal Register Volume 87, Number 9 (Thursday, January 13, 2022)]
[Rules and Regulations]
[Pages 2058-2065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00573]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 412, 416, 419, and 512

Office of the Secretary

45 CFR Part 180

[CMS-1753-CN]
RIN 0938-AU43


Medicare Program: Hospital Outpatient Prospective Payment and 
Ambulatory Surgical Center Payment Systems and Quality Reporting 
Programs; Price Transparency of Hospital Standard Charges; Radiation 
Oncology Model; Correction

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services (HHS).

ACTION: Final rule with comment period; correction.

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SUMMARY: This document corrects technical errors in the final rule with 
comment period that appeared in the Federal Register on November 16, 
2021, titled ``Medicare Program: Hospital Outpatient Prospective 
Payment and Ambulatory Surgical Center Payment Systems and Quality 
Reporting Programs; Price Transparency of Hospital Standard Charges; 
Radiation Oncology Model.''

DATES: 
    Effective date: Effective January 13, 2022.
    Applicability date: The corrections in this correcting document are 
applicable beginning January 1, 2022.

FOR FURTHER INFORMATION CONTACT:  Marjorie Baldo via email 
<a href="/cdn-cgi/l/email-protection#571a36253d38253e327915363b333817343a24793f3f2479303821"><span class="__cf_email__" data-cfemail="81cce0f3ebeef3e8e4afc3e0ede5eec1e2ecf2afe9e9f2afe6eef7">[email protected]</span></a> or at (410) 786-4617.

SUPPLEMENTARY INFORMATION:

I. Background

    In the final rule with comment period that appeared in the November 
16, 2021, Federal Register (86 FR 63458) titled ``Medicare Program: 
Hospital Outpatient Prospective Payment and Ambulatory Surgical Center 
Payment Systems and Quality Reporting Programs; Price Transparency of 
Hospital Standard Charges; Radiation Oncology Model'' (hereinafter 
referred to as the CY 2022 OPPS/ASC final rule with comment period), 
there were a number of technical and typographical errors that are 
identified and corrected in this correcting document. The provisions in 
this correction document are effective as if they had been included in 
the document that appeared in the November 16, 2021 Federal Register. 
Accordingly, the corrections are effective January 1, 2022.

II. Summary of Errors

A. Summary of Errors in the Preamble

1. Hospital Outpatient Prospective Payment System (OPPS) Corrections
    On page 63463, use of incorrect wage index assignments for 
community mental health centers (CMHCs) resulted in an inaccurate 
payment impact estimate. We stated that ``we estimate a 1.1 percent 
increase in CY 2022 payments to CMHCs relative to their CY 2021 
payments.'' We are correcting our estimate of the increase in payments 
for CMHCs from ``1.1 percent'' to ``1.6 percent''.
    On page 63490, we noted that one commenter, a hospital association, 
supported CMS's proposal to continue to unpackage Omidria in the ASC 
setting. However, there were several commenters, including several 
hospital associations, that expressed broad support for CMS's proposal 
to unpackage and pay separately for non-opioid pain management drugs 
that function as surgical supplies, including the drug Omidria. We are 
correcting the text to acknowledge the additional commenters.
    On page 63497, the table number for the table included on this page 
was inadvertently omitted from the table's title. Therefore, we are 
adding the number ``4'' to the table's title.
    On page 63543 and 63544, we listed the incorrect APC assignment for 
CPT codes 66989 and 66991. We are correcting the APC assignment for 
these codes from APC 1526 to APC 1563.
    On page 63548, second column, under section ``6. Calculus 
Aspiration With Lithotripsy Procedure (APC 5376)'' of the APC-Specific 
section, we are correcting the long descriptor for

[[Page 2059]]

HCPCS code C9761, to include the terms ``ureter,'' ``bladder,'' or 
``steerable''. The correct long descriptor for HCPCS code C9761 is 
``Cystourethroscopy, with ureteroscopy and/or pyeloscopy, with 
lithotripsy, and ureteral catheterization for steerable vacuum 
aspiration of the kidney, collecting system, ureter, bladder, and 
urethra if applicable''.
    On page 63549, in Table 23: Final SI And APC Assignment For HCPCS 
Code C9761, we inadvertently used the incorrect long descriptor for 
HCPCS code C9761. We are correcting the long descriptor for HCPCS code 
C9761 from ``Cystourethroscopy, with ureteroscopy and/or pyeloscopy, 
with lithotripsy (ureteral catheterization is included) and vacuum 
aspiration of the kidney, collecting system and urethra if 
applicable)'' to ``Cystourethroscopy, with ureteroscopy and/or 
pyeloscopy, with lithotripsy, and ureteral catheterization for 
steerable vacuum aspiration of the kidney, collecting system, ureter, 
bladder, and urethra if applicable''.
    On page 63565, we inadvertently omitted the HOP Panel 
recommendation related to CPT code 55880. Therefore, we are adding the 
language that describes the HOP Panel's recommendation for this code.
    On page 63569, we inadvertently omitted a summary of several public 
comments and our responses related to the appropriate APC assignments 
for CPT codes 0652T, 0653T, and 0654T. Therefore, we are adding a new 
subsection titled ``38. Other Procedures/Services'' that includes the 
comments and our response.
    On page 63633, Table 39, ``Drugs and Biologicals with Pass-Through 
Payment Status Expiring after CY 2022,'' we inadvertently used the 
wrong dosage unit in the long descriptor for HCPCS code J9272. The 
correct dosage unit is ``10 mg,'' not ``100 mg''. Therefore, we are 
changing the dosage unit in the long descriptor for HCPCS code J9272 
from ``100 mg'' to ``10 mg.''
    On page 63634, Table 39, ``Drugs and Biologicals with Pass-Through 
Payment Status Expiring after CY 2022,'' we inadvertently excluded 
HCPCS code J9021 (Injection, asparaginase, recombinant, (rylaze), 0.1 
mg), even though it is a drug with pass-through status expiring after 
CY 2022. Therefore, we are adding an entry for HCPCS code J9021 that 
includes the long descriptor, status indicator, APC assignment, and the 
pass-through eligibility period for the drug described by HCPCS code 
J9021.
    On pages 63812 and 63980, our revisions to the device offset 
percentages for certain device-intensive procedures results in a 
revised ASC weight scalar. Therefore, we are revising our ASC weight 
scalar from 0.8552 to 0.8546.
    On pages 63978 and 63979, Table 84, ``Estimated Impact of the CY 
2022 Changes for the Hospital Outpatient Prospective Payment System'', 
use of incorrect wage index assignments for CMHCs resulted in 
inaccurate payment impact estimates in the table. We are making changes 
in the descriptive text to accurately reflect those updates. In 
addition, the row for CMHCs of the Table 84 is being corrected to 
include payment impact estimates based on the correct CMHC wage index 
assignments.
2. Hospital Outpatient Quality Reporting (OQR) Program Corrections
    On page 63845, the title of section ``b'' incorrectly states: 
``Beginning With the CY 2023 Reporting Period/CY 2025 Payment 
Determination.'' We are correcting this from ``CY 2023 Reporting 
Period/CY 2025 Payment Determination'' to ``CY 2025 Reporting Period/CY 
2027 Payment Determination.''
    On page 63847, in the footnote for the OP-31 measure in table 63, 
we stated the incorrect timeline for mandatory reporting of the OP-31 
measure. We are correcting this from ``CY 2023 reporting period/CY 2025 
payment determination'' to ``CY 2025 reporting period/CY 2027 payment 
determination.''
    On page 63849, in Table 65, we omitted a footnote for the OP-31 
measure. We are adding the following footnote: ``OP-31 measure is 
voluntarily collected as set forth in the CY 2015 OPPS/ASC final rule 
with comment period (79 FR 66946 through 66947).''
3. Ambulatory Surgical Center Quality Reporting Program (ASCQR) 
Corrections
    On page 63892, in Table 69, the footnote for the ASC-20 measure is 
incorrect. We are removing this incorrect footnote from the table.
    On page 63894, in Table 71, we omitted the ASC-15 measure from the 
table. We are adding the ASC-15 measure to the list of measures in 
Table 71 by adding the following to the list of measures in the table: 
ASC-15a--About Facilities and Staff, ASC-15b--Communication About 
Procedure, ASC-15c--Preparation for Discharge and Recovery, ASC-15d--
Overall Rating of Facility, ASC-15e--Recommendation of Facility. We are 
also adding the following footnotes to the ASC-15 a-e measure: ``The 
ASC-15 measure is voluntarily collected effective beginning with the CY 
2026 payment determination and mandatory beginning with the CY 2027 
payment determination and subsequent years, as set forth in the CY 2022 
OPPS/ASC final rule with comment period (86 FR 63887 through 63892).''
4. Radiation Oncology Model Corrections
    On page 63917, we inadvertently omitted the word ``be'' in a 
sentence. We are correcting that omission by inserting the word. In 
addition, we are revising a sentence to correct the word ``of'' to read 
``at''.
    On page 63937, we repeated the term ``RO''. We are removing one 
instance to correct this error.
    On page 63940, we inadvertently omitted a period at the end of a 
sentence. We are correcting this omission by adding in the period.
    On page 63987, in Table 91, ``Estimates of Medicare Program Savings 
(Millions $) for Radiation Oncology Model (Starting January 1, 2022),'' 
we are correcting the Part B Premium Revenue Offset total from ``50'' 
to ``40''.

B. Summary of Errors and Corrections to the OPPS and ASC Addenda Posted 
on the CMS Website

1. OPPS Addenda Posted on the CMS Website
a. Corrections to Addendum A
    In Addendum A (OPPS APCs for CY 2022), we inadvertently assigned 
OPPS status indicator ``K'' rather than ``G'' to the drug APCs listed 
below, even though we used our equitable adjustment authority to mimic 
continued pass-through status through the end of CY 2022 for the drugs 
assigned to these APCs. Accordingly, we are correcting the OPPS status 
indicator from SI ``K'' to ``G'' in Addendum A for the drug APCs listed 
below.

<bullet> APC 9339 (Iodine i-131 iobenguane 1mci)
<bullet> APC 9180 (Inj., patisiran, 0.1 mg)
<bullet> APC 9183 (Inj., plazomicin, 5 mg)
<bullet> APC 9179 (Inj., aristada initio, 1 mg)
<bullet> APC 9182 (Inj mogamulizumab-kpkc, 1 mg)

    We inadvertently assigned HCPCS code J2798 status indicator ``N'', 
meaning that payment for the item or service is packaged, even though 
this drug will receive continued separate payment to mimic pass-through 
status during CY 2022. Accordingly, we are assigning HCPCS code J2798 
to APC 9181 (Inj., perseris, 0.5 mg) and adding this APC to Addendum A 
with an OPPS status indicator assignment of ``G'', a payment rate of 
$10.677, and a minimum unadjusted copayment of $2.14.

[[Page 2060]]

b. Corrections to Addendum B
    In Addendum B (OPPS Payment by HCPCS Code for CY 2022), we 
inadvertently assigned OPPS status indicator ``K'' or ``N'' rather than 
``G'' and assigned comment indicator ``CH'' to the HCPCS codes for the 
drugs listed below, even though we used our equitable adjustment 
authority to mimic continued pass-through status through the end of CY 
2022 for these drugs and the OPPS status indicator and APC assignments 
for these drugs are not changing. Accordingly, we changed the status 
indicator from SI ``K'' or ``N'' to ``G'' for the drug HCPCS codes 
listed below. We also removed comment indicator ``CH'' from these HCPCS 
codes because there is no change to the SI or APC assignment from CY 
2021.

<bullet> A9590 (Iodine i-131 iobenguane 1mci)
<bullet> J0222 (Inj., patisiran, 0.1 mg)
<bullet> J0291 (Inj., plazomicin, 5 mg)
<bullet> J1943 (Inj., aristada initio, 1 mg)
<bullet> J9204 (Inj mogamulizumab-kpkc, 1 mg)
<bullet> J2798 (Inj., perseris, 0.5 mg)

    In Addendum B, we inadvertently assigned HCPCS code J2798 status 
indicator ``N'', meaning that payment for the item or service is 
packaged, even though this drug will receive continued separate payment 
to mimic pass-through status during CY 2022. We are correcting this 
error in Addendum B by indicating that this HCPCS code is assigned to 
APC 9181 (Inj., perseris, 0.5 mg) with a status indicator assignment of 
``G'', a payment rate of $10.677, and a minimum unadjusted copayment of 
$2.14.
    In Addendum B, we inadvertently assigned HCPCS codes 66989 and 
66991 to APC 1526 and status indicator ``S''. We are correcting this 
error in Addendum B by indicating that HCPCS codes 66989 and 66991 are 
assigned to APC 1563 with a status indicator of ``T''.
    In Addendum B, we inadvertently assigned new HCPCS code A2003 to 
status indicator ``A''. Since this code was created in error, we are 
deleting this code from Addendum B.
c. Corrections to Addendum C
    In Addendum C, we inadvertently assigned CPT codes 66989 and 66991 
to APC 1526 and status indicator ``S''. Accordingly, we are correcting 
the APC assignment from 1526 to 1563 and status indicator ``T''.
    In Addendum C (HCPCS Codes Payable Under the 2022 OPPS by APC), we 
inadvertently assigned OPPS status indicator ``K'' rather than ``G'' to 
the drug APCs listed below, even though we used our equitable 
adjustment authority to mimic continued pass-through status through the 
end of CY 2022 for the drugs assigned to these APCs. Accordingly, we 
are correcting the OPPS status indicator from SI ``K'' to ``G'' in 
Addendum C for the HCPCS codes and drug APCs listed below.

<bullet> HCPCS code A9590; APC 9339 (Iodine i-131 iobenguane 1mci)
<bullet> HCPCS code J0222; APC 9180 (Inj., patisiran, 0.1 mg)
<bullet> HCPCS code J0291; APC 9183 (Inj., plazomicin, 5 mg)
<bullet> HCPCS code J1943; APC 9179 (Inj., aristada initio, 1 mg)
<bullet> HCPCS code J9204; APC 9182 (Inj mogamulizumab-kpkc, 1 mg)

    We inadvertently assigned HCPCS code J2798 status indicator ``N'', 
meaning that payment for the item or service is packaged, even though 
this drug will receive continued separate payment to mimic pass-through 
status during CY 2022. We are correcting this error by assigning HCPCS 
code J2798 (Inj., perseris, 0.5 mg) to APC 9181 (Inj., perseris, 0.5 
mg) and adding this APC to Addendum C with status indicator assignment 
of ``G'', a payment rate of $10.677, and the minimum unadjusted 
copayment of $2.14.
d. Corrections to Addendum P
    In Addendum P of the OPPS/ASC proposed rule, we applied a 31 
percent device offset percentage to CPT code 0618T and HCPCS code 
C9761. In Addendum P to the CY 2022 OPPS/ASC final rule with comment 
period, we assigned device offset percentages of 1.9 percent for CPT 
code 0618T and 5.15 percent for HCPCS code C9761. We are correcting the 
device offset percentages in Addendum P to display the 31 percent 
default device offset percentage as was displayed in the CY 2022 OPPS/
ASC proposed rule Addendum P for the CPT/HCPCS codes below.
    <bullet> CPT code 0618T (Insertion of iris prosthesis, including 
suture fixation and repair or removal of iris, when performed; with 
secondary intraocular lens placement or intraocular lens exchange);
    <bullet> HCPCS code C9761 (Cystourethroscopy, with ureteroscopy 
and/or pyeloscopy, with lithotripsy (ureteral catheterization is 
included) and vacuum aspiration of the kidney, collecting system and 
urethra if applicable).
    The impact file provided with the CY 2022 OPPS/ASC final rule with 
comment period at https://www.cms.gov/medicaremedicare-fee-service-paymenthospitaloutpatientpps/cms-1753-fc utilized the incorrect wage 
index values in Column F of ``2022 NFRM Impact File.11012021.xlsx'' for 
certain CMHCs, providers affected by the imputed rural floor, and 
providers affected by the cap on wage index decreases. These 
corrections to the wage index have effects on estimated CY 2022 OPPS 
and OPPS Outlier Payment, which were displayed in Columns M and N of 
that same file. As a result, we are updating the impact file to provide 
corrected numbers, which will have corrected values in those same 
columns in the updated impact file.
    To view the corrected CY 2022 OPPS status indicators, APC 
assignments, relative weights, copayment rates, device-intensive 
status, and short descriptors for Addenda A, B, and C that resulted 
from these technical corrections, we refer readers to the Addenda and 
supporting files that are posted on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices. 
Select ``CMS-1753-CN'' from the list of regulations. All corrected 
Addenda for this correcting document are contained in the zipped folder 
titled ``2022 CN OPPS Addenda'' at the bottom of the page for CMS-1753-
CN.
2. ASC Payment System Addenda Posted on the CMS Website
    In ASC Addendum AA, we inadvertently assigned CPT codes 66989 and 
66991 ``N'' (No) in column D (Subject to Multiple Procedure 
Discounting). We are correcting this error in Addendum AA by revising 
the procedure discounting status from ``N'' (No) to ``Y'' (Yes), 
indicating that the procedure is subject to multiple procedure 
discounting.
    In ASC Addendum AA, we inadvertently assigned CPT codes C9779 and 
C9780 payment indicator ``J8'' (Device-intensive procedure; paid at 
adjusted rate) in column F (Final CY 2022 Payment Indicator) even 
though these procedures are not payable in the ASC setting. We are 
correcting this error in Addendum AA by removing these codes from 
Addendum AA.
    In ASC Addendum AA, we inadvertently assigned CPT code 0414T 
payment indicator ``G2'' (Non office-based surgical procedure added in 
CY 2008 or later; payment based on OPPS relative payment weight) in 
column F (Final CY 2022 Payment Indicator), but this procedure is 
designated as device-intensive under the OPPS. Therefore, we are 
correcting this error by assigning payment indicator ``J8'' to CPT code 
0414T and correcting the ASC payment rate and ASC relative weight to 
reflect a 31 percent device offset percentage.

[[Page 2061]]

    In Addendum AA of the OPPS/ASC proposed rule, we applied a 31 
percent device offset percentage to CPT codes 66987 and 66988 and HCPCS 
code C9757 and assigned a ``J8'' payment indicator--Device-intensive 
procedure; paid at adjusted rate.--and a payment rate that reflected a 
31 percent default device offset percentage. We changed the ASC payment 
rates in the CY 2022 OPPS/ASC final rule with comment period Addendum 
AA and device offset percentages in Addendum FF to reflect 11.27 
percent for CPT code 66987, 12.35 percent for 66988, and 22.14 percent 
for HCPCS code C9757. In ASC Addendum AA, we are correcting the payment 
indicator for CPT codes 66987 and 66988 and HCPCS code C9757 to ``J8'' 
and revising the ASC payment rate and ASC relative weights to reflect a 
device offset percentage of 31 percent as was displayed in the CY 2022 
OPPS/ASC proposed rule. In ASC Addendum FF, we are correcting the 
device offset percentages for CPT codes 66987 and 66988 and HCPCS code 
C9757 to reflect the device offset percentage of 31 percent as was 
displayed in the CY 2022 OPPS/ASC proposed rule.
    In ASC addendum BB, we inadvertently assigned HCPCS code J2798 
payment indicator ``N1'', meaning that payment for the item or service 
is packaged, even though this drug will receive continued separate 
payment to mimic pass-through status during CY 2022. We are correcting 
this error in Addendum BB by changing the payment indicator from ``N1'' 
to ``K2'' and adding a payment rate of $10.68.
    In ASC Addendum FF, we inadvertently added CPT codes C9779 and 
C9780 but these procedures are not payable in the ASC setting. We are 
correcting this error by removing these codes from Addendum FF.
    In ASC Addendum FF, we inadvertently assigned CPT code 0414T 
payment indicator ``G2'' (non office-based surgical procedure added in 
CY 2008 or later; payment based on OPPS relative payment weight) under 
column D (Final CY 2022 Payment Indicator) and a device portion that 
reflects a device offset percentage of 27.06 percent but this procedure 
is designated as device-intensive under the OPPS. Therefore, we are 
correcting this error by assigning payment indicator ``J8'' (device-
intensive procedure; paid at adjusted rate) to CPT code 0414T, 
assigning a 31 percent device offset percentage, and assigning a device 
portion of $7,233.62.
    To view the corrected final CY 2022 ASC payment indicators, payment 
weights, payment rates, and multiple procedure discounting indicator 
for Addendum BB that resulted from this technical correction, we refer 
readers to the ASC Addenda and supporting files on the CMS website at: 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices. 
Select ``CMS-1753-CN'' from the list of regulations. The corrected ASC 
addenda for this correcting document are contained in the zipped folder 
titled ``2022 CN ASC Addenda'' at the bottom of the page for CMS-1753-
CN.

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 rule 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 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) 
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 of 
the 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 is 
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 correcting document does not constitute a 
rulemaking that would be subject to the notice and comment and delayed 
effective date requirements. This correcting document corrects 
technical and typographical errors in the preamble, addenda, payment 
rates, and tables included or referenced in the CY 2022 OPPS/ASC final 
rule with comment period but does not make substantive changes to the 
policies or payment methodologies that were adopted in the final rule. 
As a result, the corrections made through this correcting document are 
intended to ensure that the information in the CY 2022 OPPS/ASC final 
rule with comment period accurately reflects the policies adopted in 
that rule.
    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 CY 2022 OPPS/ASC final rule 
with comment period reflects our policies as of the date they take 
effect and are applicable.
    Furthermore, such procedures would be unnecessary, as we are not 
altering our payment methodologies or policies, but rather, we are 
simply correctly implementing the policies that we previously proposed, 
requested comment on, and subsequently finalized. This correcting 
document is intended solely to ensure that the CY 2022 OPPS/ASC final 
rule with comment period accurately reflects these payment 
methodologies and policies. For these reasons, we believe we have good 
cause to waive the notice and comment and delayed effective date 
requirements.

IV. Correction of Errors

    In FR Doc. 2021-24011 of November 16, 2021 (86 FR 63458), we are 
making the following corrections:
    1. On page 63463, second column, first full paragraph, line 9, 
``1.1 percent'' is corrected to read ``1.6 percent''.
    2. On page 63490, third column, third full paragraph, in lines 13 
through 16, the text ``One commenter, a hospital association, also 
supported CMS's proposal to continue to unpackage Omidria in the ASC 
setting'' is corrected to read ``Several commenters, including several 
hospital associations and ophthalmology professional societies, also 
provided broad support for CMS's proposal to continue to unpackage 
Omidria in the ASC setting.''
    3. On page 63497, the title of the table is corrected to read:

[[Page 2062]]

``TABLE 4: SUMMARY OF PRODUCTS MEETING CMS'S CRITERIA FOR SEPARATE 
PAYMENT IN THE ASC SETTING UNDER THE NON-OPIOID PAIN MANAGEMENT DRUGS 
THAT FUNCTION AS A SURGICAL SUPPLY PACKAGING POLICY.''

    4. On page 63543, third column, second full paragraph, the text 
``We believe that APC 1526 (New Technology--Level 26 ($4001-$4500)), 
with a payment rate of $4,250.50, most accurately accounts for the 
resources associated with furnishing MIGS'' is corrected to read ``We 
believe that APC 1563 (New Technology--Level 26 ($4001-$4500)), with a 
payment rate of $4,250.50, most accurately accounts for the resources 
associated with furnishing MIGS.''
    5. On page 63544, first column, second paragraph, the sentence ``In 
summary, after consideration of the public comments, we are finalizing 
the reassignment of CPT codes 66989 and 66991 to APC 1526 and 
assignment of CPT code 0671T to APC 5491'' is corrected to read ``In 
summary, after consideration of the public comments, we are finalizing 
the reassignment of CPT codes 66989 and 66991 to APC 1563 and 
assignment of CPT code 0671T to APC 5491.''
    6. On page 63548, second column, in the section titled ``6. 
Calculus Aspiration With Lithotripsy Procedure (APC 5376),'' the long 
descriptor for HCPCS code C9761, ``Cystourethroscopy, with ureteroscopy 
and/or pyeloscopy, with lithotripsy (ureteral catheterization is 
included) and vacuum aspiration of the kidney, collecting system and 
urethra if applicable,'' is corrected to read ``Cystourethroscopy, with 
ureteroscopy and/or pyeloscopy, with lithotripsy, and ureteral 
catheterization for steerable vacuum aspiration of the kidney, 
collecting system, ureter, bladder, and urethra if applicable.''
    7. On page 63549, in ``Table 23: Final SI And APC Assignment For 
HCPCS Code C9761,'' the long descriptor for HCPCS C9761 is corrected to 
read ``Cystourethroscopy, with ureteroscopy and/or pyeloscopy, with 
lithotripsy, and ureteral catheterization for steerable vacuum 
aspiration of the kidney, collecting system, ureter, bladder, and 
urethra if applicable''.
    8. On page 63565, third column, before the first full paragraph 
that reads ``In summary, after careful consideration of the public 
comments'' add the following text:
    ``In addition, at the August 23, 2021 HOP Panel Meeting, a 
presenter requested that we reassign CPT code 55880 to APC 5376. Based 
on the information presented, the HOP Panel recommended that CMS 
reassign CPT code 55880 to APC 5376 for CY 2022. However, as stated 
above, based on our analysis of the claims for this CY 2022 OPPS/ASC 
final rule with comment period, our data shows a geometric mean cost of 
approximately $5,708 for predecessor HCPCS code C9747 based on 279 
single claims, which is more comparable to the geometric mean cost of 
about $4,299 for APC 5375, rather than the geometric mean cost of 
approximately $8,042 for APC 5376. Consequently, we are not accepting 
the APC Panel's recommendation to reassign CPT code 55880 to APC 
5376.''
    9. On page 63569, second column, after the first partial paragraph 
and before ``IV. OPPS Payment for Devices,'' add the following text:
    ``38. Other Procedures/Services
    For CY 2022, we proposed to continue to assign the transnasal 
esophagogastroduodenoscopy (EGD) CPT codes 0652T 
(Esophagogastroduodenoscopy, flexible, transnasal; diagnostic, 
including collection of specimen(s) by brushing or washing, when 
performed (separate procedure)) and 0653T (Esophagogastroduodenoscopy, 
flexible, transnasal; with biopsy, single or multiple) to APC 5301 
(Level 1 Upper GI Procedures) with a payment rate of $830.39. In 
addition, we proposed to assign CPT code 0654T 
(Esophagogastroduodenoscopy, flexible, transnasal; with insertion of 
intraluminal tube or catheter) to APC 5302 (Level 2 Upper GI 
Procedures) with a payment rate of $1,666.59.
    Comment: Some commenters requested the reassignment of the 
transnasal EGD procedures to the next higher-level APCs within the 
Upper GI series. They stated that the costs for the surgical procedures 
are significantly different than the costs associated with the 
analogous transoral EGD CPT codes 43235, 43239, and 43241, which are 
assigned to the same corresponding APCs. Specifically, the commenters 
requested the reassignment of CPT codes 0652T and 0653T to APC 5302 
(Level 2 Upper GI Procedures) with a payment rate of $1,666.59, and CPT 
code 0654T to APC 5303 (Level 3 Upper GI Procedures), with a payment 
rate of $3,160.76. The commenters explained that the surgical procedure 
associated with CPT codes 0652T through 0654T utilize a new transnasal 
single-use endoscopy system known as EvoEndo Model LE Single-Use 
Gastroscope, which has an estimated cost of about $1,500. They stated 
that the EvoEndo device is not paid separately as a transitional pass-
through device because it is not described by HCPCS C1748 (Endoscope, 
single-use (i.e., disposable), upper gi, imaging/illumination device 
(insertable)). The commenters stated that HCPCS C1748 was created for 
the EXALT Model D Single-Use Duodenoscope, which is used during 
endoscopic retrograde cholangiopancreatography (ERCP) procedures.
    In addition, based on the cost of the EvoEndo device that is used 
in the procedure, the commenters agreed with the device-intensive 
assignment for the codes under the ASC payment system.
    Response: Because the codes are new for CY 2021 and we have no 
claims data available for OPPS ratesetting, we believe that we should 
maintain the APC assignments for CPT codes 0652T and 0653T to APC 5301, 
and 0654T to APC 5302. However, once we have claims data, we will 
review the APC assignments and determine whether a change is necessary. 
We note that we review, on an annual basis, the APC assignments for all 
items and services paid under the OPPS. In addition, we thank the 
commenters for their input on the device-intensive status for the codes 
under the ASC payment system.
    In summary, after consideration of the public comments, we are 
finalizing our proposal, without modifications. Specifically, we are 
assigning CPT codes 0652T and 0653T to APC 5301, and CPT code 0654T to 
APC 5302 for CY 2022. In addition, we are finalizing the device-
intensive status for the codes for CY 2022. The final CY 2022 payment 
rates for the codes can be found in Addendum B to the CY 2022 OPPS/ASC 
final rule with comment period. We refer readers to Addendum D1 of this 
final rule with comment period for the status indicator (SI) meanings 
for all codes reported under the OPPS. Both Addendum B and D1 are 
available via the internet on the CMS website. Finally, for the final 
ASC Device Offset Percentages for CY 2022, we refer readers to ASC 
Addendum FF of this final rule with comment period.''
    10. On page 63633, ``Table 39: Drugs and Biologicals with Pass-
Through Payment Status Expiring after CY 2022,'' fourth row, third 
column titled ``Long Descriptor,'' the figure ``100 mg'' is corrected 
to read ``10 mg''.
    11. On Page 63634, in ``Table 39: Drugs and Biologicals with Pass-
Through Payment Status Expiring after CY 2022,'' at the end of the 
table, add the following row to read as follows:

[[Page 2063]]

[GRAPHIC] [TIFF OMITTED] TR13JA22.003

    12. On page 63812, the last sentence of the second column is 
corrected to read, ``Based on updated data for this final rule with 
comment period, the final CY 2022 ASC weight scalar is 0.8546.''
    13. On page 63845, first column; under section ``b. OP-31: 
Cataracts,'' in lines 4-6, ``CY 2023 Reporting Period/CY 2025 Payment 
Determination'' is corrected to read ``CY 2025 Reporting Period/CY 2027 
Payment Determination.''
    14. On page 63847, Table 63, in the second footnote, the text ``CY 
2023 reporting period/CY 2025 payment determination'' is corrected to 
read ``CY 2025 reporting period/CY 2027 payment determination''.
    15. On page 63849, Table 65, add the footnote ``*** OP-31 measure 
is voluntarily collected as set forth in the CY 2015 OPPS/ASC final 
rule with comment period (79 FR 66946 through 66947).''
    16. On page 63892, Table 69, remove the footnote ``** We note that, 
if adoption finalized, an ASC/measure number will be assigned for this 
measure in the final rule.''
    17. On page 63894, Table 71 is revised to read as follows:
BILLING CODE 4120-01-P

[[Page 2064]]

[GRAPHIC] [TIFF OMITTED] TR13JA22.004


[[Page 2065]]


    17. On page 63917, second column, first full paragraph,
    a. In lines 4-5, the word ``be'' is inserted between ``will'' and 
``included''.
    b. In line 18, the first instance of the word ``of'' is corrected 
to read ``at''.
    18. On page 63937, first column, second partial paragraph, in line 
23, remove the term ``RO'' between the words ``that'' and ``if''.
    19. On page 63940, second column, first full paragraph, in line 12, 
insert a period between the words ``expires'' and ``CMS''.
    20. On page 63978, in Table 84, ``Estimated Impact of the CY 2022 
Changes for the Hospital Outpatient Prospective Payment System,'' the 
row for ``CMHCs'' is revised to read as follows:
[GRAPHIC] [TIFF OMITTED] TR13JA22.005

    21. On page 63979,
    a. First column,
    1. First paragraph, in line 18, ``1.1 percent'' is corrected to 
read ``1.6 percent''.
    2. Second paragraph,
    a. In line 4, ``1.0 percent'' is corrected to read ``0.5 percent''.
    b. In line 9, ``1.4 percent'' is corrected to read ``1.9 percent''.
    c. In line 12, ``1.1 percent'' is corrected to read ``1.6 
percent''.
    22. On page 63980, first column, first paragraph, in line 10, 
``0.8552'' is corrected to read ``0.8546''.
    23. On page 63987, Table 91, ``Estimates of Medicare Program 
Savings (Millions $) for Radiation Oncology Model (Starting January 1, 
2022),'' in the ``Total'' column, ``Part B Premium Revenue Offset'' 
line, the figure ``50'' is corrected to read ``40''.

Karuna Seshasai,
Executive Secretary to the Department, Department of Health and Human 
Services.
[FR Doc. 2022-00573 Filed 1-12-22; 8:45 am]
BILLING CODE 4120-01-C


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