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Rule2021-23907

Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model

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Published

November 8, 2021

Effective

January 1, 2022

Issuing agencies

Health and Human Services DepartmentCenters for Medicare & Medicaid Services

Abstract

This final rule updates the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2022. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, this rule updates requirements for the ESRD Quality Incentive Program (QIP), including a measure suppression policy for the duration of the coronavirus disease 2019 (COVID-19) public health emergency (PHE) as well as suppression of individual ESRD QIP measures for Payment Year (PY) 2022 under the measure suppression policy. This rule also finalizes that CMS will not score facilities or reduce payment to any facility under the ESRD QIP in PY 2022. Further, this rule finalizes changes to the ESRD Treatment Choices (ETC) Model, which is a mandatory payment model that is focused on encouraging greater use of home dialysis and kidney transplants, to reduce Medicare expenditures while preserving or enhancing the quality of care furnished to Medicare beneficiaries.

Full Text

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[Federal Register Volume 86, Number 213 (Monday, November 8, 2021)]
[Rules and Regulations]
[Pages 61874-62026]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23907]

[[Page 61873]]

Vol. 86

Monday,

No. 213

November 8, 2021

Part II

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Parts 412, 413, and 512

Medicare Program; End-Stage Renal Disease Prospective Payment System,
Payment for Renal Dialysis Services Furnished to Individuals With Acute
Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and
End-Stage Renal Disease Treatment Choices Model; Final Rule

Federal Register / Vol. 86 , No. 213 / Monday, November 8, 2021 /
Rules and Regulations

[[Page 61874]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 412, 413, and 512

[CMS-1749-F]
RIN 0938-AU39

Medicare Program; End-Stage Renal Disease Prospective Payment
System, Payment for Renal Dialysis Services Furnished to Individuals
With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive
Program, and End-Stage Renal Disease Treatment Choices Model

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule.

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SUMMARY: This final rule updates the End-Stage Renal Disease (ESRD)
Prospective Payment System (PPS) for calendar year (CY) 2022. This rule
also updates the payment rate for renal dialysis services furnished by
an ESRD facility to individuals with acute kidney injury (AKI). In
addition, this rule updates requirements for the ESRD Quality Incentive
Program (QIP), including a measure suppression policy for the duration
of the coronavirus disease 2019 (COVID-19) public health emergency
(PHE) as well as suppression of individual ESRD QIP measures for
Payment Year (PY) 2022 under the measure suppression policy. This rule
also finalizes that CMS will not score facilities or reduce payment to
any facility under the ESRD QIP in PY 2022. Further, this rule
finalizes changes to the ESRD Treatment Choices (ETC) Model, which is a
mandatory payment model that is focused on encouraging greater use of
home dialysis and kidney transplants, to reduce Medicare expenditures
while preserving or enhancing the quality of care furnished to Medicare
beneficiaries.

DATES: These regulations are effective on January 1, 2022.

FOR FURTHER INFORMATION CONTACT:
<a href="/cdn-cgi/l/email-protection#bdf8eeeff9eddcc4d0d8d3c9fdded0ce93d5d5ce93dad2cb">[email&#160;protected]</a>, for issues related to the ESRD PPS and
coverage and payment for renal dialysis services furnished to
individuals with AKI.
<a href="/cdn-cgi/l/email-protection#30756362747140405c59535144595f5e4370535d431e5858431e575f46">[email&#160;protected]</a>, for issues related to the
Transitional Add-On Payment Adjustment for New and Innovative Equipment
and Supplies (TPNIES).
Delia Houseal, (410) 786-2724, for issues related to the ESRD QIP.
<a href="/cdn-cgi/l/email-protection#5a1f0e1977191717131a39372974323229743d352c">[email&#160;protected]</a>, for issues related to the ESRD Treatment
Choices (ETC) Model.

SUPPLEMENTARY INFORMATION: Current Procedural Terminology (CPT)
Copyright Notice: Throughout this final rule, we use CPT[supreg] codes
and descriptions to refer to a variety of services. We note that
CPT[supreg] codes and descriptions are copyright 2020 American Medical
Association (AMA). All Rights Reserved. CPT[supreg] is a registered
trademark of the AMA. Applicable Federal Acquisition Regulations (FAR)
and Defense Federal Acquisition Regulations (DFAR) apply.

Table of Contents

To assist readers in referencing sections contained in this
preamble, we are providing a Table of Contents.

I. Executive Summary
A. Purpose
B. Summary of the Major Provisions
C. Summary of Cost and Benefits
II. Calendar Year (CY) 2022 End-Stage Renal Disease (ESRD)
Prospective Payment System (PPS)
A. Background
B. Provisions of the Proposed Rule, Public Comments, and
Responses to the Comments on the CY 2022 ESRD PPS
C. Transitional Add-On Payment Adjustment for New and Innovative
Equipment and Supplies (TPNIES) for CY 2022 Payment
III. Calendar Year (CY) 2022 Payment for Renal Dialysis Services
Furnished to Individuals With Acute Kidney Injury (AKI)
A. Background
B. Summary of the Proposed Provisions, Public Comments, and
Responses to Comments on the CY 2022 Payment for Renal Dialysis
Services Furnished to Individuals With AKI
C. Annual Payment Rate Update for CY 2022
IV. End-Stage Renal Disease Quality Incentive Program (ESRD QIP)
A. Background
B. Extraordinary Circumstances Exception (ECE) Previously
Granted for the ESRD QIP Including Notification of ECE Due to ESRD
Quality Reporting System Issues
C. Flexibilities for the ESRD QIP in Response to the COVID-19
PHE
D. Special Scoring Methodology and Payment Policy for the PY
2022 ESRD QIP
E. Updates to Requirements Beginning With the PY 2024 ESRD QIP
F. Updates for the PY 2025 ESRD QIP
G. Requests for Information (RFIs) on Topics Relevant to ESRD
QIP
V. End-Stage Renal Disease Treatment Choices (ETC) Model
A. Background
B. Summary of the Proposed Provisions, Public Comments, and
Responses to Comments on the ETC Model
C. Requests for Information (RFIs) on Topics Relevant to ETC
Model
VI. Requests for Information
A. Informing Payment Reform Under the ESRD PPS
B. Public Input to the ESRD PPS RFI Topics
C. Response to the Public Input for the CY 2022 ESRD PPS RFIs
VII. Collection of Information Requirements
A. Legislative Requirement for Solicitation of Comments
B. Requirements in Regulation Text
C. Additional Information Collection Requirements
VIII. Regulatory Impact Analysis
A. Impact Analyses
B. Overall Impact
C. Detailed Economic Analysis
D. Accounting Statement
E. Regulatory Flexibility Act Analysis (RFA)
F. Unfunded Mandates Reform Act Analysis (UMRA)
G. Federalism
H. Congressional Review Act
IX. Files Available to the Public via the Internet
Regulations Text

I. Executive Summary

A. Purpose

This rule finalizes changes related to the End-Stage Renal Disease
(ESRD) Prospective Payment System (PPS), payment for renal dialysis
services furnished to individuals with acute kidney injury (AKI), the
ESRD Quality Incentive Program (QIP), and the ESRD Treatment Choices
(ETC) Model.
1. End-Stage Renal Disease (ESRD) Prospective Payment System (PPS)
On January 1, 2011, we implemented the End-Stage Renal Disease
(ESRD) Prospective Payment System (PPS), a case-mix adjusted, bundled
PPS for renal dialysis services furnished by ESRD facilities as
required by section 1881(b)(14) of the Social Security Act (the Act),
as added by section 153(b) of the Medicare Improvements for Patients
and Providers Act of 2008 (MIPPA) (Pub. L. 110-275). Section
1881(b)(14)(F) of the Act, as added by section 153(b) of MIPPA, and
amended by section 3401(h) of the Patient Protection and Affordable
Care Act (the Affordable Care Act) (Pub. L. 111-148), established that
beginning calendar year (CY) 2012, and each subsequent year, the
Secretary of the Department of Health and Human Services (the
Secretary) shall annually increase payment amounts by an ESRD market
basket increase factor, reduced by the productivity adjustment
described in section 1886(b)(3)(B)(xi)(II) of the Act. This rule
updates the ESRD PPS for CY 2022.

[[Page 61875]]

2. Coverage and Payment for Renal Dialysis Services Furnished to
Individuals With Acute Kidney Injury (AKI)
On June 29, 2015, the President signed the Trade Preferences
Extension Act of 2015 (TPEA) (Pub. L. 114-27). Section 808(a) of the
TPEA amended section 1861(s)(2)(F) of the Act to provide coverage for
renal dialysis services furnished on or after January 1, 2017, by a
renal dialysis facility or a provider of services paid under section
1881(b)(14) of the Act to an individual with acute kidney injury (AKI).
Section 808(b) of the TPEA amended section 1834 of the Act by adding a
new subsection (r) that provides for payment for renal dialysis
services furnished by renal dialysis facilities or providers of
services paid under section 1881(b)(14) of the Act to individuals with
AKI at the ESRD PPS base rate beginning January 1, 2017. This rule
updates the AKI payment rate for CY 2022.
3. End-Stage Renal Disease Quality Incentive Program (ESRD QIP)
The End-Stage Renal Disease Quality Incentive Program (ESRD QIP) is
authorized by section 1881(h) of the Act. The Program fosters improved
patient outcomes by establishing incentives for dialysis facilities to
meet or exceed performance standards established by the Centers for
Medicare & Medicaid Services (CMS). This rule finalizes our proposals
to suppress the use of certain ESRD QIP measure data for scoring and
payment adjustment purposes in the PY 2022 ESRD QIP because we have
determined that circumstances caused by the Public Health Emergency
(PHE) for the coronavirus disease 2019 (COVID-19) pandemic have
significantly affected the validity and reliability of the measures and
resulting performance scores, as well as special scoring and payment
policies for PY 2022. We are also finalizing our proposal to update the
specifications for the SHR clinical measure beginning with the PY 2024
ESRD QIP. We are also finalizing our proposal to use CY 2019 data to
calculate the PY 2024 ESRD QIP performance standards. This final rule
further describes policies that will apply for PY 2025. Finally, this
final rule describes several requests for information that also
appeared in the CY 2022 ESRD PPS proposed rule. These requests for
information solicited stakeholder feedback on several important topics,
including strategies that we can use to address the gap in existing
health inequities, the addition of COVID-19 vaccination measures in
future rulemaking, and the use of digital quality measurement.
4. End-Stage Renal Disease Treatment Choices (ETC) Model
This rule finalizes changes to the End-Stage Renal Disease (ESRD)
Treatment Choices Model (ETC) Model, a mandatory Medicare payment model
tested under the authority of section 1115A of the Act. The ETC Model
is operated by the Center for Medicare and Medicaid Innovation
(Innovation Center), and tests the use of payment adjustments to
encourage greater utilization of home dialysis and kidney transplants,
in order to preserve or enhance the quality of care furnished to
Medicare beneficiaries while reducing Medicare expenditures. The ETC
Model includes ESRD facilities and certain clinicians caring for
beneficiaries with ESRD--or Managing Clinicians--located in Selected
Geographic Areas as participants.
The ETC Model was finalized as part of a final rule published in
the Federal Register on September 29, 2020, titled, ``Medicare Program;
Specialty Care Models to Improve Quality of Care and Reduce
Expenditures'' (85 FR 61114), referred to herein as the ``Specialty
Care Models final rule.'' The ETC Model is designed to test the
effectiveness of adjusting certain Medicare payments to ETC
Participants (ESRD facilities and Managing Clinicians--clinicians who
furnish and bill the Monthly Capitation Payment (MCP) for managing ESRD
Beneficiaries--who have been selected to participate in the ETC Model)
to encourage greater utilization of home dialysis and kidney
transplantation, support beneficiary modality choice, reduce Medicare
expenditures, and preserve or enhance the quality of care. In the
Specialty Care Models final rule, we established that the ETC Model
adjusts payments for home dialysis and home dialysis-related claims
with claim service dates from January 1, 2021 through December 31, 2023
through the Home Dialysis Payment Adjustment (HDPA). We are assessing
the rates of home dialysis and of kidney transplant waitlisting and
living donor transplantation, among beneficiaries attributed to ETC
Participants during the period beginning January 1, 2021, and ending
June 30, 2026. Based on those rates, we are applying the Performance
Payment Adjustment (PPA) to claims for dialysis and dialysis-related
services with claim service dates beginning July 1, 2022, and ending
June 30, 2027. We codified these provisions in a new subpart of the
Code of Federal Regulations (CFR) 42 CFR part 512, subpart C.
This final rule includes modifications to the ETC Model, including
changes to the home dialysis rate and transplant rate, the PPA
achievement benchmarking methodology, and the PPA improvement
benchmarking and scoring methodology. We are also adding processes and
requirements for ETC Participants to receive certain data from CMS and
including certain additional waivers and flexibilities as part of the
ETC Model test.

B. Summary of the Major Provisions

1. ESRD PPS
<bullet> Update to the ESRD PPS base rate for CY 2022: The final CY
2022 ESRD PPS base rate is $257.90. This amount reflects the
application of the wage index budget-neutrality adjustment factor
(0.99985) and a productivity-adjusted market basket increase of 1.9
percent as required by section 1881(b)(14)(F)(i)(I) of the Act,
equaling $257.90 (($253.13 x 0.99985) x 1.019 = $257.90).
<bullet> Annual update to the wage index: We adjust wage indices on
an annual basis using the most current hospital wage data and the
latest core-based statistical area (CBSA) delineations to account for
differing wage levels in areas in which ESRD facilities are located.
For CY 2022, we are updating the wage index values based on the latest
available data and continuing the 2-year transition to the Office of
Management and Budget (OMB) delineations as described in the September
14, 2018 OMB Bulletin No. 18-04.
<bullet> Update to the outlier policy: We are updating the outlier
policy using the most current data, as well as updating the outlier
services fixed-dollar loss (FDL) amounts for adult and pediatric
patients and Medicare allowable payment (MAP) amounts for adult and
pediatric patients for CY 2022 using CY 2020 claims data. Based on the
use of the latest available data, the final FDL amount for pediatric
beneficiaries will decrease from $44.78 to $26.02, and the MAP amount
will decrease from $30.88 to $27.15, as compared to CY 2021 values. For
adult beneficiaries, the final FDL amount will decrease from $122.49 to
$75.39, and the MAP amount will decrease from $50.92 to $42.75. The 1.0
percent target for outlier payments was not achieved in CY 2020.
Outlier payments represented approximately 0.6 percent of total
payments rather than 1.0 percent.
<bullet> Update to the offset amount for the transitional add-on
payment adjustment for new and innovative equipment and supplies
(TPNIES) for CY 2022: The

[[Page 61876]]

final CY 2022 average per treatment offset amount for the transitional
add-on payment adjustment for new and innovative equipment and supplies
(TPNIES) for capital-related assets that are home dialysis machines is
$9.50. This offset amount reflects the application of the productivity-
adjusted market basket increase of 1.9 percent ($9.32 x 1.019 = $9.50).
<bullet> TPNIES applications received for CY 2022: In this final
rule, we announce our determination on the one TPNIES application under
consideration for the TPNIES for CY 2022 payment.
2. Payment for Renal Dialysis Services Furnished to Individuals With
AKI
We are updating the AKI payment rate for CY 2022. The final CY 2022
payment rate is $257.90, which is the same as the base rate finalized
under the ESRD PPS for CY 2022.
3. ESRD QIP
We are adopting a measure suppression policy for the duration of
the COVID-19 PHE that enables us to suppress the use of one or more
measures in the ESRD QIP for scoring and payment adjustment purposes if
we determine that circumstances caused by the COVID-19 PHE have
significantly affected the measures and resulting performance scores.
We are also finalizing our proposal to suppress the Standardized
Hospitalization Ratio (SHR) clinical measure, the Standardized
Readmission Ratio (SRR) clinical measure, the In-Center Hemodialysis
Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS)
clinical measure, and the Long-Term Catheter Rate clinical measure for
PY 2022 under the measure suppression policy. We are also finalizing
our proposal to not score or reduce payment to any facility in PY 2022.
We are finalizing our proposal to update the specifications for the SHR
clinical measure beginning with the PY 2024 ESRD QIP. We are also
finalizing our proposal for the PY 2024 ESRD QIP to use CY 2019 data to
calculate the performance standards for that payment year. This final
rule also announces the performance standards and estimated payment
reductions that will apply for PY 2024. This final rule describes
several policies continuing for PY 2025, but does not include any new
requirements beginning with the PY 2025 ESRD QIP.
This final rule includes public comments received in response to
requests for information that appeared in the CY 2022 ESRD PPS proposed
rule. In those requests for information, we solicited stakeholder
feedback on several important topics, including closing the gap in
health equity, adding a COVID-19 vaccination measure for health care
personnel (HCP) to the ESRD QIP measure set in future rulemaking,
adding a COVID-19 vaccination measure for ESRD patients to the ESRD QIP
measure set in future rulemaking, and potential actions and priority
areas that would enable us to continue moving toward a greater digital
capture of data and use of the Fast Healthcare Interoperability
Resources (FHIR[supreg]) standard in quality measurement.
4. ETC Model
We are implementing the following changes to the ETC Model
beginning for the third Measurement Year (MY3) of the Model, which
begins January 1, 2022.
<bullet> Beneficiary Attribution for Living Kidney Donor
Transplants: To better reflect the care relationship between
beneficiaries who receive pre-emptive living donor transplants (LDT)
and the Managing Clinicians who provide their care, we are modifying
the methodology for attributing Pre-emptive LDT Beneficiaries to
Managing Clinicians, such that a Pre-emptive LDT Beneficiary will be
attributed to the Managing Clinician who submitted the most claims for
services furnished to the beneficiary during the 365 days prior to the
transplant date.
<bullet> Home Dialysis Rate Calculation: To incentivize additional
alternative renal replacement modalities under the ETC Model, we are
adding nocturnal in-center dialysis to the calculation of the home
dialysis rate for ESRD facilities and Managing Clinicians.
<bullet> Transplant Rate Beneficiary Exclusion: To better align
with common reasons transplant centers do not place patients on the
transplant waitlist, we are excluding beneficiaries with a diagnosis
of, and who are receiving treatment with chemotherapy or radiation for,
vital solid organ cancers from the calculation of the transplant rate.
<bullet> Performance Payment Adjustment Achievement Benchmarking
Methodology: When we originally finalized the ETC Model, we stated our
intent to increase achievement benchmarks above rates observed in
Comparison Geographic Areas for future model years. As such, we will
increase achievement benchmarks by 10 percent over rates observed in
Comparison Geographic Areas every two MYs, beginning in MY3 (2022). We
also will stratify achievement benchmarks based on the proportion of
attributed beneficiaries who are dually-eligible for Medicare and
Medicaid or receive the Low Income Subsidy (LIS) during the MY, in
recognition that beneficiaries with lower socioeconomic status have
lower rates of home dialysis and transplant than those with higher
socioeconomic status.
<bullet> Performance Payment Adjustment Improvement Benchmarking
and Scoring: In conjunction with the stratification of the achievement
benchmarks based on the proportion of beneficiaries who are dual-
eligible or LIS recipients, we will introduce the Health Equity
Incentive to the improvement scoring methodology used in calculating
the PPA. CMS expects that the Health Equity Incentive will encourage
ETC Participants to decrease disparities in renal replacement modality
choice among beneficiaries with lower socioeconomic status by rewarding
ETC Participants that demonstrate significant improvement in the home
dialysis rate or transplant rate among their attributed beneficiaries
who are dual-eligible or LIS recipients. We also will adjust the
improvement scoring calculation to avoid the scenario where an ETC
Participant cannot receive an improvement score because its home
dialysis rate or transplant rate was zero during the Benchmark Year.
<bullet> Performance Payment Adjustment Reports and Related Data
Sharing: To ensure that ETC Participants have timely access to ETC
Model reports, we are establishing a process under which CMS will share
certain model data with ETC Participants.
<bullet> Medicare Waivers: We are including an additional
programmatic waiver to provide Managing Clinicians who are ETC
Participants additional flexibility in furnishing the kidney disease
patient education services described in Sec. 410.48, namely a waiver
of certain telehealth requirements as necessary solely for purposes of
allowing ETC Participants to furnish kidney disease patient education
services via telehealth under the ETC Model to take effect at the end
of the COVID-19 PHE.
<bullet> Kidney Disease Patient Education Services Coinsurance
Waivers: We will permit Managing Clinicians who are ETC Participants to
reduce or waive the beneficiary coinsurance for kidney disease patient
education services, subject to certain requirements. We have made the
determination that the anti-kickback statute safe harbor for CMS-
sponsored model patient incentives (42 CFR 1001.952(ii)(2)), will be
available to protect the reduction or elimination of coinsurance that
is made in compliance with our policy.

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C. Summary of Costs and Benefits

In section VIII.C.5 of this final rule, we set forth a detailed
analysis of the impacts that the changes will have on affected entities
and beneficiaries. The impacts include the following:
1. Impacts of the Final ESRD PPS
The impact table in section VIII.C.5.a of this final rule displays
the estimated change in payments to ESRD facilities in CY 2022 compared
to estimated payments in CY 2021. The overall impact of the CY 2022
changes is projected to be a 2.5 percent increase in payments.
Hospital-based ESRD facilities have an estimated 3.3 percent increase
in payments compared with freestanding facilities with an estimated 2.5
percent increase. We estimate that the aggregate ESRD PPS expenditures
will increase by approximately $290 million in CY 2022 compared to CY
2021. This reflects a $220 million increase from the payment rate
update, a $70 million increase due to the updates to the outlier
threshold amounts, and approximately $2.5 million in estimated TPNIES
payment amounts, as further described in the next paragraph. Because of
the projected 2.5 percent overall payment increase, we estimate there
will be an increase in beneficiary coinsurance payments of 2.5 percent
in CY 2022, which translates to approximately $60 million.
Section 1881(b)(14)(D)(iv) of the Act provides that the ESRD PPS
may include such other payment adjustments as the Secretary determines
appropriate. Under this authority, CMS implemented Sec. 413.236 to
establish the TPNIES, a transitional add-on payment adjustment for new
and innovative equipment and supplies, which is not budget neutral. As
discussed in section II.C.1.a. of this final rule, we have determined
that the Tablo[supreg] System, a hemodialysis machine that has FDA
authorization for home use, has met the criteria for the TPNIES for CY
2022 payment. We estimate that the overall TPNIES payment amounts in CY
2022 would be approximately $2.5 million, of which, approximately
$490,000 would be attributed to beneficiary coinsurance amounts.
2. Impacts of the Final Payment for Renal Dialysis Services Furnished
to Individuals With AKI
The impact table in section VIII.C.5.b of this final rule displays
the estimated change in payments to ESRD facilities in CY 2022 compared
to estimated payments in CY 2021. The overall impact of the CY 2022
changes is projected to be a 1.9 percent increase in payments for
individuals with AKI. Hospital-based ESRD facilities have an estimated
2.0 percent increase in payments compared with freestanding ESRD
facilities with an estimated 1.9 percent increase. The overall impact
reflects the effects of the updated wage index and the final payment
rate update. We estimate that the aggregate payments made to ESRD
facilities for renal dialysis services furnished to patients with AKI,
at the final CY 2022 ESRD PPS base rate, will increase by $1 million in
CY 2022 compared to CY 2021.
3. Impacts of the ESRD QIP
Our finalized policy to suppress measures for the PY 2022 ESRD QIP
and to revise the scoring and payment methodology such that no facility
will receive a payment reduction necessitated a modification to our
previous estimated overall economic impact of the PY 2022 ESRD QIP (84
FR 60651). In the CY 2020 ESRD PPS final rule, we estimated that the
overall economic impact of the PY 2022 ESRD QIP would be approximately
$229 million as a result of the policies we had finalized at that time.
The $229 million figure for PY 2022 included costs associated with the
collection of information requirements, which we estimated would be
approximately $211 million, and $18 million in estimated payment
reductions across all facilities. However, as a result of the policies
we are finalizing in this final rule for the PY 2022 ESRD QIP, we are
modifying our previous estimate for PY 2022. We estimate that the new
overall economic impact of the PY 2022 ESRD QIP will be approximately
$215 million. The $215 million figure for PY 2022 only includes the
costs associated with the collection of information requirements
because there will be no payment reductions in PY 2022. We estimate
that the overall economic impact of the PY 2024 ESRD QIP will be
approximately $232 million, of which $215 million is associated with
the collection of information requirements and $17 million is
associated with the estimated payment reductions across all facilities.
We also estimate that the overall economic impact of the PY 2025 ESRD
QIP will be approximately $232 million.
4. Impacts of Changes to the ETC Model
The impact estimate in section VIII.B.4 of this final rule
describes the estimated change in anticipated Medicare program savings
arising from the ETC Model over the duration of the ETC Model as a
result of the changes in this final rule. We estimate that the ETC
Model will result in $28 million in net savings over the 6.5-year
duration of the ETC Model. We also estimate that $5 million of the
estimated $28 million in net savings will be attributable to changes in
this final rule.

II. Calendar Year (CY) 2022 End-Stage Renal Disease (ESRD) Prospective
Payment System (PPS)

A. Background

1. Statutory Background
On January 1, 2011, the Centers for Medicare & Medicaid Services
(CMS) implemented the End-Stage Renal Disease (ESRD) Prospective
Payment System (PPS), a case-mix adjusted bundled PPS for renal
dialysis services furnished by ESRD facilities, as required by section
1881(b)(14) of the Social Security Act (the Act), as added by section
153(b) of the Medicare Improvements for Patients and Providers Act of
2008 (MIPPA). Section 1881(b)(14)(F) of the Act, as added by section
153(b) of MIPPA and amended by section 3401(h) of the Patient
Protection and Affordable Care Act (the Affordable Care Act),
established that beginning with CY 2012, and each subsequent year, the
Secretary of the Department of Health and Human Services (the
Secretary) shall annually increase payment amounts by an ESRD market
basket increase factor reduced by the productivity adjustment described
in section 1886(b)(3)(B)(xi)(II) of the Act.
Section 632 of the American Taxpayer Relief Act of 2012 (ATRA)
(Pub. L. 112-240) included several provisions that apply to the ESRD
PPS. Section 632(a) of ATRA added section 1881(b)(14)(I) to the Act,
which required the Secretary, by comparing per patient utilization data
from 2007 with such data from 2012, to reduce the single payment for
renal dialysis services furnished on or after January 1, 2014 to
reflect the Secretary's estimate of the change in the utilization of
ESRD-related drugs and biologicals (excluding oral-only ESRD-related
drugs). Consistent with this requirement, in the CY 2014 ESRD PPS final
rule we finalized $29.93 as the total drug utilization reduction and
finalized a policy to implement the amount over a 3- to 4-year
transition period (78 FR 72161 through 72170).
Section 632(b) of ATRA prohibited the Secretary from paying for
oral-only ESRD-related drugs and biologicals under the ESRD PPS prior
to January 1, 2016. Section 632(c) of ATRA required the Secretary, by
no later than January 1, 2016, to analyze the case-mix payment
adjustments under section 1881(b)(14)(D)(i) of the Act and make

[[Page 61878]]

appropriate revisions to those adjustments.
On April 1, 2014, the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93) was enacted. Section 217 of PAMA included
several provisions that apply to the ESRD PPS. Specifically, sections
217(b)(1) and (2) of PAMA amended sections 1881(b)(14)(F) and (I) of
the Act and replaced the drug utilization adjustment that was finalized
in the CY 2014 ESRD PPS final rule (78 FR 72161 through 72170) with
specific provisions that dictated the market basket update for CY 2015
(0.0 percent) and how the market basket should be reduced in CY 2016
through CY 2018.
Section 217(a)(1) of PAMA amended section 632(b)(1) of ATRA to
provide that the Secretary may not pay for oral-only ESRD-related drugs
under the ESRD PPS prior to January 1, 2024. Section 217(a)(2) of PAMA
further amended section 632(b)(1) of ATRA by requiring that in
establishing payment for oral-only drugs under the ESRD PPS, the
Secretary must use data from the most recent year available. Section
217(c) of PAMA provided that as part of the CY 2016 ESRD PPS
rulemaking, the Secretary shall establish a process for (1) determining
when a product is no longer an oral-only drug; and (2) including new
injectable and intravenous products into the ESRD PPS bundled payment.
Finally, on December 19, 2014, the President signed the Stephen
Beck, Jr., Achieving a Better Life Experience Act of 2014 (ABLE) (Pub.
L. 113-295). Section 204 of ABLE amended section 632(b)(1) of ATRA, as
amended by section 217(a)(1) of PAMA, to provide that payment for oral-
only renal dialysis services cannot be made under the ESRD PPS bundled
payment prior to January 1, 2025.
2. System for Payment of Renal Dialysis Services
Under the ESRD PPS, a single per-treatment payment is made to an
ESRD facility for all the renal dialysis services defined in section
1881(b)(14)(B) of the Act and furnished to individuals for the
treatment of ESRD in the ESRD facility or in a patient's home. We have
codified our definition of renal dialysis services at Sec. 413.171,
which is in 42 CFR part 413, subpart H, along with other ESRD PPS
payment policies. The ESRD PPS base rate is adjusted for
characteristics of both adult and pediatric patients and accounts for
patient case-mix variability. The adult case-mix adjusters include five
categories of age, body surface area, low body mass index, onset of
dialysis, and four comorbidity categories (that is, pericarditis,
gastrointestinal tract bleeding, hereditary hemolytic or sickle cell
anemia, myelodysplastic syndrome). A different set of case-mix
adjusters are applied for the pediatric population. Pediatric patient-
level adjusters include two age categories (under age 22, or age 22-26)
and two dialysis modalities (that is, peritoneal or hemodialysis)
(Sec. 413.235(a) and (b)).
The ESRD PPS provides for three facility-level adjustments. The
first payment adjustment accounts for ESRD facilities furnishing a low
volume of dialysis treatments (Sec. 413.232). The second adjustment
reflects differences in area wage levels developed from core-based
statistical areas (CBSAs) (Sec. 413.231). The third payment adjustment
accounts for ESRD facilities furnishing renal dialysis services in a
rural area (Sec. 413.233).
There are four additional payment adjustments under the ESRD PPS.
The ESRD PPS provides adjustments, when applicable, for: (1) A training
add-on for home and self-dialysis modalities (Sec. 413.235(c)); (2) an
additional payment for high cost outliers due to unusual variations in
the type or amount of medically necessary care (Sec. 413.237); (3) a
transitional drug add-on payment adjustment (TDAPA) for certain new
renal dialysis drugs and biological products (Sec. 413.234(c)); and
(4) a transitional add-on payment adjustment for new and innovative
equipment and supplies (TPNIES) for certain qualifying, new and
innovative renal dialysis equipment and supplies (Sec. 413.236(d)).
3. Updates to the ESRD PPS
Policy changes to the ESRD PPS are proposed and finalized annually
in the Federal Register. The CY 2011 ESRD PPS final rule was published
on August 12, 2010 in the Federal Register (75 FR 49030 through 49214).
That rule implemented the ESRD PPS beginning on January 1, 2011 in
accordance with section 1881(b)(14) of the Act, as added by section
153(b) of MIPPA, over a 4-year transition period. Since the
implementation of the ESRD PPS, we have published annual rules to make
routine updates, policy changes, and clarifications.
On November 9, 2020, we published a final rule in the Federal
Register titled, ``Medicare Program; End-Stage Renal Disease
Prospective Payment System, Payment for Renal Dialysis Services
Furnished to Individuals With Acute Kidney Injury, and End-Stage Renal
Disease Quality Incentive Program,'' referred to herein as the ``CY
2021 ESRD PPS final rule''. In that rule, we updated the ESRD PPS base
rate, wage index, and outlier policy, for CY 2021. We also finalized an
update to the ESRD PPS wage index to adopt the 2018 OMB delineations
with a transition period, changes to the eligibility criteria and
determination process for the TPNIES, an expansion of the TPNIES to
include certain new and innovative capital-related assets that are home
dialysis machines, an addition to the ESRD PPS base rate to include
calcimimetics in the ESRD PPS bundled payment, and a change to the low-
volume payment adjustment eligibility criteria and attestation
requirement to account for the coronavirus disease 2019 (COVID-19)
Public Health Emergency (PHE). For further detailed information
regarding these updates, see 85 FR 71398.

B. Provisions of the Proposed Rule, Public Comments, and Responses to
the Comments on the CY 2022 ESRD PPS

The proposed rule, titled ``Medicare Program; End-Stage Renal
Disease Prospective Payment System, Payment for Renal Dialysis Services
Furnished to Individuals With Acute Kidney Injury, End-Stage Renal
Disease Quality Incentive Program, and End-Stage Renal Disease
Treatment Choices Model'' (86 FR 36322 through 36437), referred to as
the ``CY 2022 ESRD PPS proposed rule,'' was published in the Federal
Register on July 9, 2021, with a comment period that ended on August
31, 2021. In that proposed rule, we proposed to make a number of annual
updates for CY 2022, including updates to the ESRD PPS base rate, wage
index, outlier policy, and the offset amount for TPNIES for capital-
related assets that are home dialysis machines used in the home. The
proposed rule presented a summary of the two CY 2022 TPNIES
applications that we received by the February 1, 2021 deadline and our
analysis of the applicants' claims related to substantial clinical
improvement (SCI) and other eligibility criteria for the TPNIES.
We received 286 public comments on our proposals, including
comments from kidney and dialysis organizations, such as large and
small dialysis organizations, for-profit and non-profit ESRD
facilities, ESRD networks, and a dialysis coalition. We also received
comments from patients; healthcare providers for adult and pediatric
ESRD beneficiaries; home dialysis services and advocacy organizations;
provider and legal advocacy organizations; administrators and insurance
groups; a non-profit dialysis association, a professional association,
and alliances for kidney care and home dialysis stakeholders; drug and
device manufacturers; health care systems; a

[[Page 61879]]

health solutions company; and the Medicare Payment Advisory Commission
(MedPAC).
In this final rule, we provide a summary of each proposed
provision, a summary of the public comments received and our responses
to them, and the policies we are finalizing for the CY 2022 ESRD PPS.
1. CY 2022 ESRD PPS Update
a. CY 2022 ESRD Bundled (ESRDB) Market Basket Update, Productivity
Adjustment, and Labor-Related Share
In accordance with section 1881(b)(14)(F)(i) of the Act, as added
by section 153(b) of MIPPA and amended by section 3401(h) of the
Affordable Care Act, beginning in 2012, the ESRD PPS payment amounts
are required to be annually increased by an ESRD market basket increase
factor and reduced by the productivity adjustment described in section
1886(b)(3)(B)(xi)(II) of the Act. The application of the productivity
adjustment may result in the increase factor being less than 0.0
percent for a year and may result in payment rates for a year being
less than the payment rates for the preceding year. The statute also
provides that the market basket increase factor should reflect the
changes over time in the prices of an appropriate mix of goods and
services used to furnish renal dialysis services.
As required under section 1881(b)(14)(F)(i) of the Act, CMS
developed an all-inclusive ESRD Bundled (ESRDB) input price index (75
FR 49151 through 49162). In the CY 2015 ESRD PPS final rule, we rebased
and revised the ESRDB input price index to reflect a 2012 base year (79
FR 66129 through 66136). Subsequently, in the CY 2019 ESRD PPS final
rule, we finalized a rebased ESRDB input price index to reflect a 2016
base year (83 FR 56951 through 56962).
Although ``market basket'' technically describes the mix of goods
and services used for ESRD treatment, this term is also commonly used
to denote the input price index (that is, cost categories, their
respective weights, and price proxies combined) derived from a market
basket. Accordingly, the term ``ESRDB market basket,'' as used in this
document, refers to the ESRDB input price index.
We proposed to use the CY 2016-based ESRDB market basket as
finalized and described in the CY 2019 ESRD PPS final rule (83 FR 56951
through 56962) to compute the CY 2022 ESRDB market basket increase
factor based on the best available data. Consistent with historical
practice, we proposed to estimate the ESRDB market basket update based
on IHS Global Inc.'s (IGI's) forecast using the most recently available
data. IGI is a nationally recognized economic and financial forecasting
firm with which we contract to forecast the components of the market
baskets. Using this methodology and the IGI first quarter 2021 forecast
of the CY 2016-based ESRDB market basket (with historical data through
the fourth quarter of 2020), the proposed CY 2022 ESRDB market basket
increase factor was 1.6 percent.
Under section 1881(b)(14)(F)(i) of the Act, for CY 2012 and each
subsequent year, the ESRD market basket percentage increase factor
shall be reduced by the productivity adjustment described in section
1886(b)(3)(B)(xi)(II) of the Act. The productivity adjustment is
calculated using a projection of multifactor productivity (MFP), which
is derived by subtracting the contribution of labor and capital input
growth from output growth. We finalized the detailed methodology for
deriving the projection of MFP in the CY 2012 ESRD PPS final rule (76
FR 40503 through 40504). The most up-to-date MFP projection methodology
is available on the CMS website at <a href="https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/Downloads/MFPMethodology.pdf">https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/Downloads/MFPMethodology.pdf</a>. We noted in the
CY 2022 ESRD PPS proposed rule that for CY 2022 and beyond, we are
changing the name of this adjustment to refer to it as the productivity
adjustment, which is the term used in sections 1881(b)(14)(F)(i) and
1886(b)(3)(B)(xi)(II) of the Act, rather than the multifactor
productivity or MFP adjustment. This is not a change in policy, as we
will continue to use the same methodology for deriving the adjustment
and rely on the same underlying data. Using this methodology and the
IGI first quarter 2021 forecast, the proposed productivity adjustment
for CY 2022 (the 10-year moving average of MFP for the period ending CY
2022) was 0.6 percent.
As a result of these provisions, the proposed CY 2022 ESRD market
basket increase factor reduced by the productivity adjustment was 1.0
percent. The proposed market basket increase factor is calculated by
starting with the proposed CY 2022 ESRDB market basket percentage
increase factor of 1.6 percent and reducing it by the proposed
productivity adjustment (the 10-year moving average of MFP for the
period ending CY 2022) of 0.6 percent.
As is our general practice, we proposed that if more recent data
became available after the publication of the proposed rule and before
the publication of the final rule (for example, a more recent estimate
of the CY 2016-based ESRD market basket increase factor or productivity
adjustment), we would use such data, if appropriate, to determine the
final CY 2022 market basket update and productivity adjustment in this
final rule (85 FR 36327).
We invited public comment on our proposals for the CY 2022 ESRD
market basket update and productivity adjustment. The following is a
summary of the public comments received on these proposals and our
responses.
Comment: Several commenters encouraged CMS to examine the data
sources and other elements to ensure that the market basket update
reflects ESRD facilities' current experience. The commenters stated
that while they understand CMS must follow the statutory framework for
the annual market basket update, they believe that the proposed CY 2022
market basket update appears low given inflation and rising expenses
including rent and labor. Several commenters expressed that they
support the proposed ESRD PPS annual payment rate update for CY 2022
and support the use of more recent data for the market basket update
and productivity adjustment, if available, to determine the final
update factors for CY 2022. MedPAC commented that while it recognizes
that CMS must provide the statutorily mandated payment update of the
market basket minus the productivity adjustment, the Commission has
concluded that this increase is not warranted based on their analysis
of payment adequacy, which includes an assessment of beneficiary
access, supply of ESRD facilities, and ESRD facilities' access to
capital, quality, and financial indicators for the sector. MedPAC
further recommended that Congress should eliminate the update to the
ESRD PPS base rate for CY 2022.
Response: We acknowledge the concerns of some of the commenters and
appreciate the support of some of the commenters regarding the proposed
ESRD PPS annual payment rate update and use of more recent data to
determine the market basket and productivity adjustment in
determination of the final update factor. We also appreciate MedPAC's
comments but note that the ESRD market basket increase factor is
mandated by statute. For this final rule, we have incorporated more
current historical data and revised forecasts provided by IGI that
factor in expected price and wage pressures. By incorporating the most
recent estimates available of the market basket update

[[Page 61880]]

and productivity adjustment, we believe these data reflect the best
available projection of input price inflation faced by ESRD facilities
for CY 2022, adjusted for economy-wide productivity, which is required
by statute. As stated previously in this section of the final rule,
consistent with our proposal to use more recent data, the CY 2022 ESRD
market basket increase factor is 1.9 percent based on the more recent
IGI third quarter 2021 forecast.
Comment: A few commenters noted that while they understand that the
productivity adjustment is statutorily required, they believe that the
experience of ESRD facilities argues against the idea that productivity
can be improved year-over-year.
Response: We acknowledge the commenters' concerns regarding
productivity growth at the economy-wide level and its application to
ESRD facilities. As the commenter acknowledges, however, section
1881(b)(14)(F)(i) of the Act requires the application of the
productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of
the Act to the ESRD PPS market basket increase factor for 2012 and
subsequent years. We will continue to monitor the impact of the payment
updates, including the effects of the productivity adjustment, on ESRD
provider margins as well as beneficiary access to care as reported by
MedPAC.
Comment: One commenter recommended CMS replace the current price
proxy for the non-Erythropoietin Stimulating Agents (ESA)
Pharmaceutical cost weight in the 2016-based ESRD market basket
Producer Price Index (PPI)--Commodity--Vitamin, nutrient, and hematinic
preparations) with BLS PPI Commodity Data for Chemicals and Allied
Products-Drugs and Pharmaceuticals, seasonally adjusted (BLS Series ID:
WPS063 Series). The commenter further stated that they do not believe
that the current proxy appropriately captures the price of drugs that
fall within this category as they are not over-the-counter vitamins but
prescription-only, synthesized hormones. The commenter also noted that
there are new drugs under development currently that likely will be
added to the ESRD PPS bundled payment during the next few years. The
commenter asserted that an alternative proxy for the non-ESA drugs
should be based on prescription drugs rather than the current proxy.
Response: We appreciate the commenter's suggestion and share the
commenter's desire to use the most appropriate price proxy for non-ESA
drugs in the ESRD market basket. As described in the CY 2019 ESRD PPS
final rule (83 FR 56960 through 56961), and in the CY 2021 ESRD PPS
final rule (85 FR 71428), we believe the PPI for Vitamins, Nutrients,
and Hematinic Preparation (VNHP) is the most appropriate price proxy
for non-ESA drugs and analysis of the Average Sales Price (ASP) data
for Non-ESA drugs in the ESRD PPS bundled payment suggests the trends
in the PPI VNHP trends are reasonable. We appreciate the commenter's
concern about the potential shifts in the mix of drugs within the ESRD
PPS bundled payment as new drugs enter the market. We will continue to
monitor the impact that these changes have on the relative cost share
weights and the mix of Non-ESA drugs included in the ESRD PPS bundled
payment in the ESRDB market basket, and propose changes if appropriate
in future rulemaking.
Final Rule Action: After considering the public comments,
consistent with our historical practice and our proposal, we are
estimating the market basket increase and the productivity adjustment
based on IGI's forecast using the most recent available data. Based on
IGI's third quarter 2021 forecast of the 2016-based ESRDB market basket
with historical data through the second quarter of 2021, the 2016-based
ESRDB market basket update for CY 2022 is 2.4 percent. IGI's 2021 third
quarter forecast reflects a higher CY 2022 inflationary outlook
compared to IGI's 2021 first quarter forecast, which is resulting in a
notable upward revision to the CY 2022 ESRD market basket update for
the CY 2022 ESRD PPS final rule (2.4 percent) compared to the CY 2022
ESRD PPS proposed rule (1.6 percent). As the economic impacts of the
COVID-19 pandemic ease, the relatively higher inflation is resulting in
relatively higher projected growth in wage, medical materials and
supplies, and capital prices.
Based on the more recent data available from IGI's third quarter
2021 forecast, the current estimate of the productivity adjustment for
CY 2022 (the 10-year moving average of MFP for the period ending CY
2021) is 0.5 percentage point. Therefore, the final CY 2022 ESRD market
basket adjusted for the productivity adjustment is projected to be 1.9
percent (2.4 percent market basket update reduced by 0.5 percentage
point productivity adjustment).
For the CY 2022 ESRD PPS payment update, we proposed to continue
using a labor-related share of 52.3 percent for the ESRD PPS payment,
which was finalized in the CY 2019 ESRD PPS final rule (83 FR 56963).
We invited public comment on the proposed labor-related share for CY
2022. We did not receive any comments on the proposal to continue using
a labor-related share of 52.3 percent for CY 2022 and, therefore, are
finalizing the continued use of a 52.3 percent labor-related share as
proposed.
b. CY 2022 ESRD PPS Wage Indices
(1) Background
Section 1881(b)(14)(D)(iv)(II) of the Act provides that the ESRD
PPS may include a geographic wage index payment adjustment, such as the
index referred to in section 1881(b)(12)(D) of the Act, as the
Secretary determines to be appropriate. In the CY 2011 ESRD PPS final
rule (75 FR 49200), we finalized an adjustment for wages at Sec.
413.231. Specifically, CMS adjusts the labor-related portion of the
base rate to account for geographic differences in the area wage levels
using an appropriate wage index, which reflects the relative level of
hospital wages and wage-related costs in the geographic area in which
the ESRD facility is located. We use OMB's CBSA-based geographic area
designations to define urban and rural areas and their corresponding
wage index values (75 FR 49117). OMB publishes bulletins regarding CBSA
changes, including changes to CBSA numbers and titles. The bulletins
are available online at <a href="https://www.whitehouse.gov/omb/information-for-agencies/bulletins/">https://www.whitehouse.gov/omb/information-for-agencies/bulletins/</a>.
For CY 2022, we proposed to update the wage indices to account for
updated wage levels in areas in which ESRD facilities are located using
our existing methodology. We use the most recent pre-floor, pre-
reclassified hospital wage data collected annually under the inpatient
PPS. The ESRD PPS wage index values are calculated without regard to
geographic reclassifications authorized under sections 1886(d)(8) and
(d)(10) of the Act and utilize prefloor hospital data that are
unadjusted for occupational mix. For CY 2022, the updated wage data are
for hospital cost reporting periods beginning on or after October 1,
2017, and before October 1, 2018 (fiscal year [FY] 2018 cost report
data).
We have also adopted methodologies for calculating wage index
values for ESRD facilities that are located in urban and rural areas
where there is no hospital data. For a full discussion, see CY 2011 and
CY 2012 ESRD PPS final rules at 75 FR 49116 through 49117 and 76 FR
70239 through 70241, respectively. For urban areas with no hospital
data, we compute the average wage index value of all urban areas within
the State to serve as a reasonable

[[Page 61881]]

proxy for the wage index of that urban CBSA, that is, we use that value
as the wage index. For rural areas with no hospital data, we compute
the wage index using the average wage index values from all contiguous
CBSAs to represent a reasonable proxy for that rural area. We apply the
statewide urban average based on the average of all urban areas within
the State to Hinesville-Fort Stewart, Georgia (78 FR 72173), and we
apply the wage index for Guam to American Samoa and the Northern
Mariana Islands (78 FR 72172).
A wage index floor value (0.5000) is applied under the ESRD PPS as
a substitute wage index for areas with very low wage index values.
Currently, all areas with wage index values that fall below the floor
are located in Puerto Rico. However, the wage index floor value is
applicable for any area that may fall below the floor. A description of
the history of the wage index floor under the ESRD PPS can be found in
the CY 2019 ESRD PPS final rule (83 FR 56964 through 56967).
An ESRD facility's wage index is applied to the labor-related share
of the ESRD PPS base rate. In the CY 2019 ESRD PPS final rule (83 FR
56963), we finalized a labor-related share of 52.3 percent, which is
based on the 2016-based ESRDB market basket. In the CY 2021 ESRD PPS
final rule (85 FR 71436), we updated the OMB delineations as described
in the September 14, 2018 OMB Bulletin No. 18-04, beginning with the CY
2021 ESRD PPS wage index. In addition, we finalized the application of
a 5 percent cap on any decrease in an ESRD facility's wage index from
the ESRD facility's wage index from the prior CY. We finalized that the
transition would be phased in over 2 years, such that the reduction in
an ESRD facility's wage index would be capped at 5 percent in CY 2021,
and no cap would be applied to the reduction in the wage index for the
second year, CY 2022. Thus, for CY 2022, the labor-related share to
which a facility's wage index would be applied is 52.3 percent.
The comments received on the proposed CY 2022 ESRD PPS wage index
and our responses to the comments are set forth below.
Comment: A coalition of dialysis organizations and a professional
association acknowledged and supported the final phase-in of the
updated OMB delineations for CY 2022. These commenters, along with
another large dialysis organization, suggested that CMS consider ways
to better tailor the ESRD PPS wage index, including using additional
data beyond the hospital wage data. Another small dialysis organization
expressed concerns that the ESRD PPS wage index does not keep pace with
the hospital wage index, and identified several potential changes to
align the ESRD PPS wage index with the hospital wage index, including
the application of a statewide rural floor on wage indices, the
application of different labor-related share percentages for areas with
wage indices above and below 1, and allowing ESRD facilities to
reclassify to a different geographic area. Another commenter, a non-
profit kidney care alliance, expressed similar concerns and urged CMS
to promptly address these disparities between the ESRD PPS wage index
and the hospital wage index in rulemaking in the near future.
Response: We thank the commenters for their support, and we
appreciate the suggestions for improving the ESRD PPS wage index. We
did not propose changes to the ESRD PPS wage index methodology for CY
2022, and therefore we are not finalizing any changes to that
methodology in this final rule. However, we will take these comments
into consideration to potentially inform future rulemaking.
Comment: Three commenters, including a large dialysis organization,
a non-profit health insurance organization in Puerto Rico, and a
healthcare group in Puerto Rico, commented on the wage index for ESRD
facilities located in Puerto Rico. These commenters recommended that
CMS increase the wage index floor from 0.5000 to 0.5500; they noted
that in the CY 2019 ESRD PPS proposed rule, CMS reported that its own
analysis indicated that Puerto Rico's wage index likely lies between
0.5100 and 0.5500. They noted that CMS further stated that any wage
index values less than 0.5936 are considered outlier values. They
pointed out that CMS still finalized a floor at 0.50 and characterized
it as a balance between providing additional payments to affected areas
while minimizing the impact on the ESRD PPS base rate. The commenters
also recommended that CMS align the ESRD PPS wage index with the
hospital wage index by applying to the ESRD PPS wage index the policy
finalized in the FY 2020 IPPS final rule (84 FR 42326 through 42328)
that increases the wage index for hospitals with a wage index value
below the 25th percentile wage index. Two of the commenters further
suggested that CMS conduct a survey of registered nurse (RN) and health
worker wages specifically in standalone ESRD facilities in Puerto Rico
as a means for wage index reform, noting that there is specific
professional scope of practice standards for technicians in Puerto Rico
outpatient facilities. Commenters asserted that RNs must provide all
ESRD care in Puerto Rico outpatient facilities per local scope of
practice laws, and that CMS should evaluate inpatient and outpatient
facility data separately in order to get a fully accurate projection of
wage costs for ESRD providers in Puerto Rico. Another commenter
recommended that CMS evaluate policy inequities between the ESRD PPS
wage index for ESRD facilities located in Puerto Rico compared to other
states and territories, taking into consideration the unique
circumstances that affect Puerto Rico, including its shortage of
healthcare specialists and labor work force, remote geography,
transportation and freighting costs, drug pricing, and lack of
transitional care services.
Response: We thank the commenters for sharing their concerns
regarding the ESRD PPS wage index for ESRD facilities in Puerto Rico
and their suggestions for wage index reform. As noted in the CY 2018
ESRD PPS final rule (82 FR 50747) and the CY 2019 ESRD PPS final rule
(83 FR 56964 through 56967), we have received conflicting information
from commenters about the local scope of practice for RNs and other
staff impact on facility costs in Puerto Rico. Since we did not propose
any changes to the wage index floor or wage index methodology for CY
2022, we are not finalizing any changes to those policies in this final
rule. However, we appreciate the concerns that commenters have raised
and we will take these thoughtful suggestions into account when
considering future rulemaking.
Final Rule Action: We are finalizing the CY 2022 ESRD PPS wage
indices based on the latest hospital wage data as proposed. For CY
2022, the labor-related share to which a facility's wage index is
applied is 52.3 percent. As we finalized in the CY 2021 ESRD PPS final
rule (85 FR 71436), there will be no cap applied to the reduction in
the ESRD PPS wage index for CY 2022. The final CY 2022 ESRD PPS wage
index is set forth in Addendum A and is available on the CMS website at
<a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/End-Stage-Renal-Disease-ESRD-Payment-Regulations-and-Notices">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/End-Stage-Renal-Disease-ESRD-Payment-Regulations-and-Notices</a>. Addendum A provides a crosswalk between the CY 2021 wage index
and the CY 2022 wage index. Addendum B provides an ESRD facility level
impact analysis. Addendum B is available on the CMS website at https://
www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/End-
Stage-

[[Page 61882]]

Renal-Disease-ESRD-Payment-Regulations-and-Notices.
c. CY 2022 Update to the Outlier Policy
Section 1881(b)(14)(D)(ii) of the Act requires that the ESRD PPS
include a payment adjustment for high cost outliers due to unusual
variations in the type or amount of medically necessary care, including
variability in the amount of erythropoiesis-stimulating agents (ESAs)
necessary for anemia management. Some examples of the patient
conditions that may be reflective of higher facility costs when
furnishing dialysis care would be frailty, obesity, and comorbidities,
such as secondary hyperparathyroidism. The ESRD PPS recognizes high
cost patients, and we have codified the outlier policy and our
methodology for calculating outlier payments at Sec. 413.237.
The policy provides that the following ESRD outlier items and
services are included in the ESRD PPS bundle: (1) Renal dialysis drugs
and biological products that were or would have been, prior to January
1, 2011, separately billable under Medicare Part B; (2) renal dialysis
laboratory tests that were or would have been, prior to January 1,
2011, separately billable under Medicare Part B ; (3) renal dialysis
medical/surgical supplies, including syringes, used to administer renal
dialysis drugs and biological products that were or would have been,
prior to January 1, 2011, separately billable under Medicare Part B;
(4) renal dialysis drugs and biological products that were or would
have been, prior to January 1, 2011, covered under Medicare Part D,
including renal dialysis oral-only drugs effective January 1, 2025; and
(5) renal dialysis equipment and supplies, except for capital-related
assets that are home dialysis machines (as defined in Sec.
413.236(a)(2)), that receive the transitional add-on payment adjustment
as specified in Sec. 413.236 after the payment period has ended.
In the CY 2011 ESRD PPS final rule (75 FR 49142), CMS stated that
for purposes of determining whether an ESRD facility would be eligible
for an outlier payment, it would be necessary for the facility to
identify the actual ESRD outlier services furnished to the patient by
line item (that is, date of service) on the monthly claim. Renal
dialysis drugs, laboratory tests, and medical/surgical supplies that
are recognized as outlier services were specified in Transmittal 2134,
dated January 14, 2011.\1\ Furthermore, CMS uses administrative
issuances to update the renal dialysis service items available for
outlier payment via our quarterly update CMS Change Requests, when
applicable. For example, we use these updates to identify renal
dialysis service drugs that were or would have been covered under
Medicare Part D for outlier eligibility purposes and items and services
that have been incorrectly identified as eligible outlier services.
---------------------------------------------------------------------------

\1\ Transmittal 2033 issued August 20, 2010, was rescinded and
replaced by Transmittal 2094, dated November 17, 2010. Transmittal
2094 identified additional drugs and laboratory tests that may also
be eligible for ESRD outlier payment. Transmittal 2094 was rescinded
and replaced by Transmittal 2134, dated January 14, 2011, which
included one technical correction. <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R2134CP.pdf">https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R2134CP.pdf</a>.
---------------------------------------------------------------------------

Under Sec. 413.237, an ESRD facility is eligible for an outlier
payment if its actual or imputed Medicare Allowable Payment (MAP)
amount per treatment for ESRD outlier services exceeds a threshold. The
MAP amount represents the average incurred amount per treatment for
services that were or would have been considered separately billable
services prior to January 1, 2011. The threshold is equal to the ESRD
facility's predicted ESRD outlier services MAP amount per treatment
(which is case-mix adjusted and described in the following paragraphs)
plus the fixed-dollar loss (FDL) amount. In accordance with Sec.
413.237(c), facilities are paid 80 percent of the per treatment amount
by which the imputed MAP amount for outlier services (that is, the
actual incurred amount) exceeds this threshold. ESRD facilities are
eligible to receive outlier payments for treating both adult and
pediatric dialysis patients.
In the CY 2011 ESRD PPS final rule and codified in Sec.
413.220(b)(4), using 2007 data, we established the outlier percentage,
which is used to reduce the per treatment base rate to account for the
proportion of the estimated total payments under the ESRD PPS that are
outlier payments, at 1.0 percent of total payments (75 FR 49142 through
49143). We also established the FDL amounts that are added to the
predicted outlier services MAP amounts. The outlier services MAP
amounts and FDL amounts are different for adult and pediatric patients
due to differences in the utilization of separately billable services
among adult and pediatric patients (75 FR 49140). As we explained in
the CY 2011 ESRD PPS final rule (75 FR 49138 through 49139), the
predicted outlier services MAP amounts for a patient are determined by
multiplying the adjusted average outlier services MAP amount by the
product of the patient-specific case-mix adjusters applicable using the
outlier services payment multipliers developed from the regression
analysis used to compute the payment adjustments.
For CY 2022, we proposed that the outlier services MAP amounts and
FDL amounts would be derived from claims data from CY 2020. As we
stated in the CY 2022 ESRD PPS proposed rule (86 FR 36329), we believe
that any adjustments made to the MAP amounts under the ESRD PPS should
be based upon the most recent data year available to best predict any
future outlier payments; therefore, we proposed the outlier thresholds
for CY 2022 would be based on utilization of renal dialysis items and
services furnished under the ESRD PPS in CY 2020.
We also stated that we recognize that the utilization of ESAs and
other outlier services have continued to decline under the ESRD PPS,
and that we have lowered the MAP amounts and FDL amounts every year
under the ESRD PPS. As discussed in section II.B.1.c of this final
rule, CY 2020 claims data show outlier payments represent approximately
0.6 percent of total payments.
(1) CY 2022 Update to the Outlier Services MAP Amounts and FDL Amounts
For this final rule, the outlier services MAP amounts and FDL
amounts were updated using 2020 claims data, as we proposed to do for
CY 2022. The impact of this update is shown in Table 1, which compares
the outlier services MAP amounts and FDL amounts used for the outlier
policy in CY 2021 with the updated estimates for this final rule. The
estimates for the CY 2022 outlier policy, which are included in Column
II of Table 1, were inflation adjusted to reflect projected 2022 prices
for outlier services.

[[Page 61883]]

[GRAPHIC] [TIFF OMITTED] TR08NO21.000

As demonstrated in Table 1, the estimated FDL amount per treatment
that determines the CY 2022 outlier threshold amount for adults (Column
II; $75.39) is lower than that used for the CY 2021 outlier policy
(Column I; $122.49). The lower threshold is accompanied by a decrease
in the adjusted average MAP for outlier services from $50.92 to $42.75.
For pediatric patients, there is a decrease in the FDL amount from
$44.78 to $26.02. There is a corresponding decrease in the adjusted
average MAP for outlier services among pediatric patients, from $30.08
to $27.15.
We estimate that the percentage of patient months qualifying for
outlier payments in CY 2022 will be 7.08 percent for adult patients and
12.89 percent for pediatric patients, based on the 2020 claims data.
The outlier MAP and FDL amounts continue to be lower for pediatric
patients than adults due to the continued lower use of outlier services
(primarily reflecting lower use of ESAs and other injectable drugs).
(2) Outlier Percentage
In the CY 2011 ESRD PPS final rule (75 FR 49081) and under Sec.
413.220(b)(4), we reduced the per treatment base rate by 1 percent to
account for the proportion of the estimated total payments under the
ESRD PPS that are outlier payments as described in Sec. 413.237. Based
on the 2020 claims, outlier payments represented approximately 0.6
percent of total payments, which is below the 1 percent target due to
declines in the use of outlier services. As we stated in the CY 2022
ESRD PPS proposed rule (86 FR 36330), recalibration of the thresholds
using 2020 data is expected to result in aggregate outlier payments
close to the 1 percent target in CY 2022. We stated in the CY 2022 ESRD
PPS proposed rule that we believe the update to the outlier MAP and FDL
amounts for CY 2022 would increase payments for ESRD beneficiaries
requiring higher resource utilization. This would move us closer to
meeting our 1 percent outlier policy goal, because we are using more
current data for computing the MAP and FDL, which is more in line with
current outlier services utilization rates. We noted in the CY 2022
ESRD PPS proposed rule that recalibration of the FDL amounts would
result in no change in payments to ESRD facilities for beneficiaries
with renal dialysis items and services that are not eligible for
outlier payments.
The comments and our responses to the comments on our proposed
updates to the outlier policy are set forth below.
Comment: Several commenters suggested alternatives to our proposed
outlier MAP amounts, FDL amounts, and outlier percentage target for CY
2022. One large dialysis organization commented in support of using the
most recent available CY 2020 claims data for determining the CY 2022
outlier services MAP amounts and FDL amounts, but suggested that CMS
undertake further action to address the issue of outlier payments
falling short of the 1 percent target. A professional organization of
pediatric nephrologists expressed concern that the decreasing FDL and
MAP amounts suggest that the cost of delivering pediatric ESRD care is
not appropriately paid under Medicare by either the existing ESRD PPS
bundled payment or through the outlier adjustment. Several commenters
recommended that CMS set the CY 2022 outlier percentage less than 1
percent. For example, one commenter, a coalition of dialysis
organizations, suggested that because the CY 2020 claims data showed
that outlier payments represented approximately 0.6 percent of total
ESRD PPS payments, CMS could set the CY 2022 outlier ``pool''
[percentage] at 0.6 percent. Similarly, a professional association
suggested that because historical data shows that CMS regularly pays
out between 0.5 and 0.6 percent of ESRD PPS payments as outlier
payments, CMS should reduce the outlier percentage to better match the
use of the outlier pool. Other commenters, including a large dialysis
organization and a provider advocacy organization, urged CMS to reduce
the CY 2022 outlier pool to no more than 0.5 percent of projected

[[Page 61884]]

aggregate ESRD PPS spending. Another large dialysis organization
recommended CMS adopt the proposed FDL and MAP amounts for CY 2022, but
urged CMS to set the outlier percentage to 0.6 percent.
Additionally, several of these commenters suggested that in any
year when the outlier pool retains dollars that are not paid out, CMS
should return those dollars to providers or reallocate those dollars to
support reducing the barriers that create inequities in the care
dialysis patients receive.
Response: We appreciate the support for the proposed use of CY 2020
data and the thoughtful suggestions provided by commenters. We
acknowledge that, even with annually adjusting the MAP and FDL to
reflect the most recent utilization and costs of ESRD PPS eligible
outlier services, total outlier payments have not yet reached the 1
percent target. However, it is also true that use of eligible ESRD
outlier services declined each year. That is, ESRD facilities incurred
lower costs than anticipated, and those savings accrued to facilities
more than offsetting the extent to which the consequent outlier
payments fell short of the 1.0 percent target. We also note that
declining FDL and MAP amounts do not in themselves suggest that the
ESRD PPS fails to adequately pay for the delivery of either pediatric
or adult ESRD care. Rather, the ESRD PPS outlier policy was established
to account for unusual variations in the type or amount of medically
necessary care. Declining FDL and MAP amounts suggest that there is
less costly variation in such care that is not included in the ESRD PPS
bundled payment.
We appreciate the comments suggesting solutions for refining the
outlier policy methodology, for example, reducing the outlier
percentage withhold to less than 1 percent or establishing a mechanism
that pays back ESRD facilities those allocated outlier amounts that did
not pay out in the year projected. We did not propose any modifications
to the ESRD PPS outlier policy for CY 2022, so we are not finalizing
any changes to the methodology in this final rule. However, as
discussed in section VI.E of the CY 2022 ESRD PPS proposed rule (86 FR
36400), CMS is considering potential revisions to the calculation of
the outlier percentage to address stakeholder concerns, including
concerns about the 1 percent outlier percentage, and issued a request
for information in the CY 2022 ESRD PPS proposed rule to seek feedback
on the acceptability of possible payment adjustment methods and to
solicit information that would better inform future modifications to
the methodology through rulemaking.
Final Rule Action: After considering the public comments, we are
finalizing the updated outlier thresholds for CY 2022 displayed in
Column II of Table 1 of this final rule and based on CY 2020 data.
d. Final Impacts to the CY 2022 ESRD PPS Base Rate
(1) ESRD PPS Base Rate
In the CY 2011 ESRD PPS final rule (75 FR 49071 through 49083), CMS
established the methodology for calculating the ESRD PPS per-treatment
base rate, that is, ESRD PPS base rate, and calculating the per
treatment payment amount, which are codified at Sec. Sec. 413.220 and
413.230. The CY 2011 ESRD PPS final rule also provides a detailed
discussion of the methodology used to calculate the ESRD PPS base rate
and the computation of factors used to adjust the ESRD PPS base rate
for projected outlier payments and budget neutrality in accordance with
sections 1881(b)(14)(D)(ii) and 1881(b)(14)(A)(ii) of the Act,
respectively. Specifically, the ESRD PPS base rate was developed from
CY 2007 claims (that is, the lowest per patient utilization year as
required by section 1881(b)(14)(A)(ii) of the Act), updated to CY 2011,
and represented the average per treatment MAP for composite rate and
separately billable services. In accordance with section 1881(b)(14)(D)
of the Act and our regulation at Sec. 413.230, the per-treatment
payment amount is the sum of the ESRD PPS base rate, adjusted for the
patient specific case-mix adjustments, applicable facility adjustments,
geographic differences in area wage levels using an area wage index,
and any applicable outlier payment, training adjustment add-on, TDAPA,
and TPNIES.
(2) Annual Payment Rate Update for CY 2022
We are finalizing an ESRD PPS base rate for CY 2022 of $257.90.
This update reflects several factors, described in more detail as
follows:
Wage Index Budget-Neutrality Adjustment Factor: We compute a wage
index budget-neutrality adjustment factor that is applied to the ESRD
PPS base rate. For CY 2022, we did not propose any changes to the
methodology used to calculate this factor, which is described in detail
in the CY 2014 ESRD PPS final rule (78 FR 72174). We computed the final
CY 2022 wage index budget-neutrality adjustment factor using treatment
counts from the 2020 claims and facility-specific CY 2021 payment rates
to estimate the total dollar amount that each ESRD facility would have
received in CY 2021. The total of these payments became the target
amount of expenditures for all ESRD facilities for CY 2022. Next, we
computed the estimated dollar amount that would have been paid for the
same ESRD facilities using the ESRD PPS wage index for CY 2022. As
discussed in section II.B.1.b of this final rule, the ESRD PPS wage
index for CY 2022 includes an update to the most recent hospital wage
data, use of the 2018 OMB delineations, and no cap on wage index
decreases applied for CY 2022. The total of these payments becomes the
new CY 2022 amount of wage-adjusted expenditures for all ESRD
facilities. The wage index budget-neutrality factor is calculated as
the target amount divided by the new CY 2022 amount. When we multiplied
the wage index budget neutrality factor by the applicable CY 2022
estimated payments, aggregate payments to ESRD facilities would remain
budget neutral when compared to the target amount of expenditures. That
is, the wage index budget neutrality adjustment factor ensures that
wage index adjustments do not increase or decrease aggregate Medicare
payments with respect to changes in wage index updates. The CY 2022
wage index budget-neutrality adjustment factor is 0.99985. This
application would yield a CY 2022 ESRD PPS base rate of $253.09 prior
to the application of the market basket increase ($253.13 x 0.99985 =
$253.09).
Market Basket Increase: Section 1881(b)(14)(F)(i)(I) of the Act
provides that, beginning in 2012, the ESRD PPS payment amounts are
required to be annually increased by the ESRD market basket percentage
increase factor. The latest CY 2022 projection of the ESRDB market
basket percentage increase factor is 2.4 percent. In CY 2022, this
amount must be reduced by the productivity adjustment described in
section 1886(b)(3)(B)(xi)(II) of the Act, as required by section
1881(b)(14)(F)(i)(II) of the Act. As discussed previously in section
II.B.1.a of this final rule, the final productivity adjustment for CY
2021 is 0.5 percent, thus yielding an update to the base rate of 1.9
percent for CY 2022. Therefore, the final CY 2022 ESRD PPS proposed
base rate is $257.90 ($253.02 x 1.019 = $257.90).
The comments and our responses to the comments on our updates to
the CY 2022 ESRD PPS base rate are set forth below.
Comment: Several commenters raised concerns about the comorbidity
case-mix adjustments under the ESRD PPS

[[Page 61885]]

and recommended eliminating them for CY 2022. Two commenters, including
a large dialysis organization and a coalition of dialysis organizations
encouraged CMS to eliminate the remaining comorbidity case-mix
adjustments and thereby increase the ESRD PPS base rate for CY 2022.
These commenters noted that the percent of claims with these conditions
is relatively low and has been declining over time. These commenters
argued that as the frequency of these conditions declines in the
claims, maintaining these adjusters results in the loss of money from
the system that could be redirected toward patient care. One of these
commenters further argued that this means the dollars that Congress
intended to go to providing items and services for individuals who
receive dialysis are being inappropriately diverted away from that
care. Both commenters further suggested that the years of discussion
pertaining to patient-level adjustments, particularly the issues with
the comorbid case-mix adjusters, and CMS's questions through the
request for information (RFI) in the CY 2022 ESRD PPS proposed rule,
should constitute enough notice to support their removal from the
regression model for CY 2022, which includes the co-morbid case-mix
adjusters in the calculation of the ESRD PPS payment.
Response: As the commenters noted, we included a detailed RFI
regarding the ESRD PPS case mix adjustments in the CY 2022 ESRD PPS
proposed rule (82 FR 36398 through 36409). A summary of the comments
received in response to the RFI is provided in section VI.A of this
final rule, and we will provide further information on the CMS ESRD PPS
website in the future. CMS is considering alternative approaches to
calculating the ESRD PPS case-mix adjustments that directly address
stakeholder concerns, and appropriately reflect resource use and costs.
The RFI in the CY 2022 ESRD PPS proposed rule both sought feedback on
the variation of case-mix adjustments with duration of dialysis
treatment, and solicited information on alternative proxies for
resource utilization that can be reported at the patient/treatment
level in order to better inform future modifications to this
methodology through rulemaking.
With regard to the comment about removing the co-morbid adjustment
from the case-mix for CY 2022, we note that due to the nature of
regression analysis, which is how the current payment adjustors are
set, making that type of adjustment would affect all the patient-level
and facility-level adjustments. This can impact budget neutrality
requirements and affect provider impacts differently than if adopted
incrementally. Payment system changes can also require extensive
efforts by CMS and providers to implement, and could not be implemented
for CY 2022. While we discussed these case-mix adjustments in the RFI,
we did not propose to make changes to the comorbidity case-mix
adjustments for CY 2022; therefore, we are not finalizing any changes
to that policy in this final rule.
Comment: Two commenters, a large dialysis organization and a non-
profit health insurance organization in Puerto Rico, urged CMS to
evaluate the accuracy of the ESRD PPS base rate as applied to payments
for ESRD facilities located in Puerto Rico. These commenters encouraged
CMS to consider the differences in patient characteristics between
Puerto Rico and the mainland U.S., as well as differences in size,
service capacity, and locality between the average ESRD facility in
Puerto Rico versus other mainland providers.
Response: As mentioned previously in this section of the final
rule, and as further discussed in section VI.D of the CY 2022 ESRD PPS
proposed rule (86 FR 36399), CMS is considering alternative approaches
to calculating the case-mix adjustment, including duration of dialysis
treatment to allocate composite rate costs for patients with higher
resource use due to patient characteristics as reflected in the case-
mix adjustments. We are also considering all the commenters'
suggestions in response to the RFI for alternative proxies for
allocation of composite rate costs for those patients whose medical and
physiologic characteristics require more resource use. We appreciate
these comments and will take them into consideration to potentially
inform future rulemaking.
Final Rule Action: We are finalizing a CY 2022 ESRD PPS base rate
of $257.90. This amount reflects the CY 2022 wage index budget-
neutrality adjustment factor of 0.99985, and the CY 2022 ESRD PPS
productivity-adjusted market basket update of 1.9 percent.
e. Update to the Average per Treatment Offset Amount for Home Dialysis
Machines
In the CY 2021 ESRD PPS final rule (85 FR 71427), we expanded
eligibility for the TPNIES under Sec. 413.236 to include certain
capital-related assets that are home dialysis machines when used in the
home for a single patient. To establish the basis of payment for the
TPNIES for these items, we finalized the additional steps that the
Medicare Administrative Contractors (MACs) must follow to calculate a
pre-adjusted per treatment amount, using the prices they establish
under Sec. 413.236(e) for a capital-related asset that is a home
dialysis machine, as well as the methodology that CMS uses to calculate
the average per treatment offset amount for home dialysis machines that
is used in the MACs' calculation, to account for the cost of the home
dialysis machine that is already in the ESRD PPS base rate. For
purposes of this final rule, we will refer to this as the ``TPNIES
offset amount.''
The methodology for calculating the TPNIES offset amount is set
forth in Sec. 413.236(f)(3). Section Sec. 413.236(f)(3)(v) states
that effective January 1, 2022, CMS annually updates the amount
determined in Sec. 413.236(f)(3)(iv) by the ESRD bundled market basket
percentage increase factor minus the productivity adjustment factor.
The TPNIES for capital-related assets that are home dialysis machines
is based on 65 percent of the MAC-determined pre-adjusted per treatment
amount, reduced by the TPNIES offset amount, and is paid for 2-calendar
years.
As we discussed in the CY 2022 ESRD PPS proposed rule (86 FR
36331), the CY 2021 TPNIES offset amount for capital-related equipment
that are home dialysis machines used in the home is $9.32. We stated
that the proposed CY 2022 ESRD bundled market basket increase factor
minus the productivity adjustment is 1.0 percent (1.6 percent minus 0.6
percent). Applying the proposed update factor of 1.010 to the proposed
CY 2021 TPNIES offset amount resulted in a proposed CY 2022 TPNIES
offset amount of $9.41 ($9.32 x 1.010). We proposed to update this
calculation using the most recent data available in the CY 2022 ESRD
PPS final rule.
The comments and our responses to the comments on the proposed
update to the TPNIES offset amount are set forth below.
Comment: One large dialysis organization commented in support of
the current TPNIES policy, but recommended that CMS recalculate the
TPNIES offset amount using a 7-year depreciation schedule, which the
commenter asserted would more accurately align with real-world home
dialysis machine use. This commenter also recommended that CMS revise
the TPNIES policy to allow for a modification to the ESRD PPS base rate
to ensure ongoing access to innovative technologies.
Response: We appreciate the commenter's suggestion for improving

[[Page 61886]]

the TPNIES policy. As we discussed in the CY 2021 ESRD PPS final rule
(85 FR 71421 through 71422), section 104.17 of the Provider
Reimbursement Manual discusses that the useful life of a capital-
related asset is its expected useful life to the provider, not
necessarily the inherent useful or physical life. Further, the manual
provides that under the Medicare program, only the American Hospital
Association (AHA) guidelines may be used in selecting a proper useful
life for computing depreciation. In keeping with the Medicare policy,
we established reliance on the AHA guidelines to determine the useful
life of a capital-related asset that is a home dialysis machine, which
is 5-years and not the 7 years suggested by the commenter (see 42 CFR
413.236(f)(i)). We note that we considered alternatives, but concluded
that this approach was simpler and appropriate for encouraging and
supporting the uptake of new and innovative renal dialysis equipment
and supplies (85 FR 71422).
We did not propose changes to the methodology for updating the
TPNIES offset amount for CY 2022, and therefore we are not finalizing
any changes to that methodology in this final rule. However, we will
take these recommendations into consideration to potentially inform
future rulemaking.
Final Rule Action: We are finalizing our proposal to calculate the
CY 2022 TPNIES offset amount using the most recent data available. The
CY 2021 TPNIES offset amount for capital-related equipment that are
home dialysis machines used in the home is $9.32. As discussed
previously in section II.B.1.a of this final rule, the CY 2022 ESRD
bundled market basket increase factor minus the productivity adjustment
is 1.9 percent (2.4 percent minus 0.5 percent). Applying the
productivity adjustment factor of 1.019 to the CY 2021 TPNIES offset
amount results in a CY 2022 TPNIES offset amount of $9.50 ($9.32 x
1.019).
f. TDAPA and TPNIES Public Comments and Responses
We also received several public comments on topics related to the
TPNIES and the TDAPA policies under the ESRD PPS, including from
individuals, such as ESRD beneficiaries, individual health care
providers, manufacturers, healthcare groups, patient advocacy
organizations, hospital associations, dialysis associations, as well as
various dialysis, kidney, and professional organizations. While these
comments related to issues that we either did not discuss in the CY
2022 ESRD PPS proposed rule or that we discussed for background or
context, but for which we did not propose changes, a summary of the
significant comments and our responses are set forth below.
Comment: Commenters overwhelmingly wrote in support of innovation
in ESRD management generally and some specifically mentioned existing
or upcoming technologies they thought would benefit ESRD patients.
Other commenters expressed interest in seeing improvements in
peritoneal dialysis, including on-line generation of dialysate and
prevention of infections. Commenters also expressed support for home
hemodialysis, citing its flexibility, convenience, and the comfort it
provides patients. Commenters expressed interest in seeing improvements
in home hemodialysis such as lower costs, more availability, better
cannulation, reduced burden on patients and caregivers, and more
convenient generation of dialysate. Commenters also stated they would
like to see improvements in home dialysis that would increase
retention, improve quality of delivered dialysate, or reduce
complications.
Response: We appreciate the supportive comments regarding
innovation in ESRD therapy. Like the commenters, CMS supports
innovation in the ESRD space and we look forward to seeing new
technologies that improve care for beneficiaries with ESRD.
Comments: Commenters provided input on the substantial clinical
improvement criteria for the TPNIES under Sec. 413.236(b)(5) and Sec.
412.87(b)(1), offering specific recommendations on what CMS should
consider in making a determination of substantial clinical improvement
for the TPNIES. Commenters suggested that certain innovations could be
considered evidence of substantial clinical improvement over existing
technologies, such as: Technical specifications that make home dialysis
easier for disadvantaged persons, real time dialysis fluid preparation,
and real-time monitoring of patients' treatment sessions.
Many commenters encouraged CMS to utilize evidence outside of
randomized controlled trials (RCTs) as a way of demonstrating
significant clinical improvement due to the challenges of running
clinical trials involving patients with ESRD, including difficulty in
patient recruitment and financial barriers for innovators to conduct
these types of large-scale, long-term trials. One commenter who agreed
with this stated that CMS also should not only rely on short, small-
scale studies conducted by device manufacturers as the standard for
substantial clinical improvement. A home dialysis advocacy organization
commented that evidence from a clinical trial, abstracts of data, and
expert opinion, such as letters from medical professionals, are
sufficient to support a showing of substantial clinical improvement,
rather than RCTs. That same commenter added that given the challenges
specific to conducting studies in the ESRD space, real-world evidence
gathered from studies conducted outside the U.S. may be extrapolated to
Medicare beneficiaries when appropriate. One commenter, a beneficiary,
emphasized that patients may have a drastically different perspective
of substantial clinical improvement compared to CMS. That commenter
stated that greater flexibility is of the utmost importance to home
dialysis patients and, therefore, therapies that allow patients with
ESRD to resume their normal day-to-day activities should be considered
to show substantial clinical improvement. Other commenters also
encouraged the use of patient preferences, patient-reported outcomes,
and other patient-centered data when evaluating substantial clinical
improvement. A commenter encouraged CMS to weigh the reduction of
patient and care partner burden, improved communication with the care
team, and improved safety through the reduction of severe adverse
events in the evaluation of evidence.
Other commenters offered suggestions for CMS's current process of
evaluating evidence of substantial clinical improvement. Commenters
asked that CMS provide guidance on evidence of substantial clinical
improvement specific to the ESRD space, such as the development of a
set of ESRD patient-reported outcomes for assessing substantial
clinical improvement criteria. Other commenters also suggested using a
panel of patients with ESRD to assist with tasks such as developing the
set of patient-reported outcomes or providing insight for these
outcomes during the evaluation process. Some commenters asked CMS to
clarify how data and real-world evidence submitted as part of a TPNIES
application is reviewed and weighed during the review process.
Response: We appreciate the comments regarding the CMS evaluation
process for the substantial clinical improvement criterion for the
TPNIES. In response to commenters' suggestions regarding the use of
expert opinions, clinical trials, abstracts of data, unpublished
sources, and letters from health care providers in our analysis, we
note that under Sec. 413.236(b)(5), CMS may consider all of these
types of data,

[[Page 61887]]

among others, in making a determination of substantial clinical
improvement. A list of information sources that we may consider in our
determination is set forth in Sec. 412.87(b)(1)(iii). Additionally,
under Sec. 412.87(b)(1)(iii)(N), CMS may consider other appropriate
information sources not otherwise listed in our regulations on
substantial clinical improvement. Further, we are taking the
opportunity to clarify that RCTs, while potentially informative, are
not required under existing regulations to demonstrate substantial
clinical improvement for purpose of the TPNIES. While we did not
propose changes to the substantial clinical improvement criteria for
the TPNIES in the CY 2022 ESRD PPS proposed rule, we will consider
these comments for future rulemaking. We encourage ESRD patients and
patient advocacy organizations to submit comments on our annual ESRD
PPS proposed rules to provide their perspectives on TPNIES
applications.
Comment: Several commenters suggested changes to the TPNIES policy
under the ESRD PPS. Commenters suggested using FDA determinations (for
example, Breakthrough Device designations) in evaluating TPNIES
applications. Commenters also asked for CMS to provide increased
feedback to applicants throughout the TPNIES application process,
including providing: Parallel feedback on data needed to support a
TPNIES application as the manufacturers are working towards FDA
marketing authorization, public review of the complete application
prior to finalizing TPNIES application decisions, and an appeal process
for manufacturers whose TPNIES applications were not approved. In
addition, commenters recommended that CMS remove MACs' discretion in
determining pricing of new and innovative renal dialysis equipment and
supplies, as provided under Sec. 413.236(e), and requested that CMS
set more defined payment parameters and public transparency around
pricing. Other commenters suggested expanding the TPNIES policy to
allow TPNIES payments to ESRD facilities with home dialysis devices on
operating leases and to expand the TPNIES eligibility to include all
capital-related assets, not just home dialysis machines, as allowed
under Sec. 413.236(b)(6). We also received comments requesting various
extensions to the TPNIES application deadlines and payment periods such
as: Extending the duration of the TPNIES payment to 3 years, extending
application timetables for device manufacturers applying for the TPNIES
in the early years of the policy, and extending application timetables
for manufacturers impacted by the COVID-19 PHE.
Response: We thank the public for their comments. Because we did
not propose any changes to the TPNIES policy in the CY 2022 ESRD PPS
proposed rule, we are not making any changes to that policy in this
final rule; however, we will consider the commenters' recommendations
for future rulemaking.
Comment: Several commenters also suggested changes to the TDAPA
policy under Sec. 413.234. For example, one commenter stated that CMS
should consider implementing the substantial clinical improvement
criteria used to evaluate the TPNIES applications for the TDAPA
applications, and another commenter stated that CMS should not apply
the TDAPA to biosimilar drugs.
Response: We thank the public for their comments. Because we did
not propose any changes to the TDAPA policy in the CY 2022 ESRD PPS
proposed rule, we are not making any changes to that policy in this
final rule; however, we will consider the commenters' recommendations
for future rulemaking.

C. Transitional Add-On Payment Adjustment for New and Innovative
Equipment and Supplies (TPNIES) for CY 2022 Payment

1. Background
In the CY 2020 ESRD PPS final rule (84 FR 60681 through 60698), CMS
established the transitional add-on payment adjustment for new and
innovative equipment and supplies (TPNIES) under the ESRD PPS, under
the authority of section 1881(b)(14)(D)(iv) of the Act, in order to
support ESRD facility use and beneficiary access to these new
technologies. We established this add-on payment adjustment to help
address the unique circumstances experienced by ESRD facilities when
incorporating new and innovative equipment and supplies into their
businesses and to support ESRD facilities transitioning or testing
these products during the period when they are new to market. We added
Sec. 413.236 to establish the eligibility criteria and payment
policies for the TPNIES.
In the CY 2020 ESRD PPS final rule (84 FR 60650), we established in
Sec. 413.236(b) that for dates of service occurring on or after
January 1, 2020, we will provide the TPNIES to an ESRD facility for
furnishing a covered equipment or supply only if the item: (1) Has been
designated by CMS as a renal dialysis service under Sec. 413.171; (2)
is new, meaning granted marketing authorization by the Food and Drug
Administration (FDA) on or after January 1, 2020; (3) is commercially
available by January 1 of the particular calendar year, meaning the
year in which the payment adjustment would take effect; (4) has a
Healthcare Common Procedure Coding System (HCPCS) application submitted
in accordance with the official Level II HCPCS coding procedures by
September 1 of the particular calendar year; (5) is innovative, meaning
it meets the substantial clinical improvement criteria specified in the
Inpatient Prospective Payment System (IPPS) regulations at Sec.
412.87(b)(1) and related guidance, and (6) is not a capital related
asset that an ESRD facility has an economic interest in through
ownership (regardless of the manner in which it was acquired).
Regarding the innovation requirement in Sec. 413.236(b)(5), in the
CY 2020 ESRD PPS final rule (84 FR 60690), we stated that we will use
the following criteria to evaluate substantial clinical improvement for
purposes of the TPNIES under the ESRD PPS based on the IPPS substantial
clinical improvement criteria in Sec. 412.87(b)(1) and related
guidance:
A new technology represents an advance that substantially improves,
relative to renal dialysis services previously available, the diagnosis
or treatment of Medicare beneficiaries. First, CMS considers the
totality of the circumstances when making a determination that a new
renal dialysis equipment or supply represents an advance that
substantially improves, relative to renal dialysis services previously
available, the diagnosis or treatment of Medicare beneficiaries.
Second, a determination that a new renal dialysis equipment or supply
represents an advance that substantially improves, relative to renal
dialysis services previously available, the diagnosis or treatment of
Medicare beneficiaries means one of the following:
<bullet> The new renal dialysis equipment or supply offers a
treatment option for a patient population unresponsive to, or
ineligible for, currently available treatments; or
<bullet> The new renal dialysis equipment or supply offers the
ability to diagnose a medical condition in a patient population where
that medical condition is currently undetectable, or offers the ability
to diagnose a medical condition earlier in a patient population than
allowed by currently available methods, and there must also be evidence
that use of the new renal

[[Page 61888]]

dialysis service to make a diagnosis affects the management of the
patient; or
<bullet> The use of the new renal dialysis equipment or supply
significantly improves clinical outcomes relative to renal dialysis
services previously available as demonstrated by one or more of the
following: A reduction in at least one clinically significant adverse
event, including a reduction in mortality or a clinically significant
complication; a decreased rate of at least one subsequent diagnostic or
therapeutic intervention; a decreased number of future hospitalizations
or physician visits; a more rapid beneficial resolution of the disease
process treatment including, but not limited to, a reduced length of
stay or recovery time; an improvement in one or more activities of
daily living; an improved quality of life; or, a demonstrated greater
medication adherence or compliance; or,
<bullet> The totality of the circumstances otherwise demonstrates
that the new renal dialysis equipment or supply substantially improves,
relative to renal dialysis services previously available, the diagnosis
or treatment of Medicare beneficiaries.
Third, evidence from the following published or unpublished
information sources from within the U.S. or elsewhere may be sufficient
to establish that a new renal dialysis equipment or supply represents
an advance that substantially improves, relative to renal dialysis
services previously available, the diagnosis or treatment of Medicare
beneficiaries: Clinical trials, peer reviewed journal articles; study
results; meta-analyses; consensus statements; white papers; patient
surveys; case studies; reports; systematic literature reviews; letters
from major healthcare associations; editorials and letters to the
editor; and public comments. Other appropriate information sources may
be considered.
Fourth, the medical condition diagnosed or treated by the new renal
dialysis equipment or supply may have a low prevalence among Medicare
beneficiaries. Fifth, the new renal dialysis equipment or supply may
represent an advance that substantially improves, relative to services
or technologies previously available, the diagnosis or treatment of a
subpopulation of patients with the medical condition diagnosed or
treated by the new renal dialysis equipment or supply.
In the CY 2020 ESRD PPS final rule (84 FR 60681 through 60698), we
also established a process modeled after IPPS's process of determining
if a new medical service or technology meets the substantial clinical
improvement criteria specified in Sec. 412.87(b)(1). Specifically,
similar to the IPPS New Technology Add-On Payment, we wanted to align
our goals with the agency's efforts to transform the healthcare
delivery system for the ESRD beneficiary through competition and
innovation to provide patients with better value and results. As we
discussed in the CY 2020 ESRD PPS final rule (84 FR 60682), we believe
it is appropriate to facilitate access to new and innovative equipment
and supplies through add-on payments similar to the IPPS New Technology
Add-On Payment and to provide stakeholders with standard criteria for
both inpatient and outpatient settings. In Sec. 413.236(c), we
established a process for our announcement of TPNIES determinations and
a deadline for consideration of new renal dialysis equipment or supply
applications under the ESRD PPS. CMS will consider whether a new renal
dialysis equipment or supply meets the eligibility criteria specified
in Sec. 413.236(b) and summarize the applications received in the
annual ESRD PPS proposed rules. Then, after consideration of public
comments, we will announce the results in the Federal Register as part
of our annual updates and changes to the ESRD PPS in the ESRD PPS final
rule. In the CY 2020 ESRD PPS final rule, we also specified certain
deadlines for the application requirements. We noted that we would only
consider a complete application received by February 1 prior to the
particular calendar year. In addition, we required that FDA marketing
authorization for the equipment or supply must occur by September 1
prior to the particular calendar year. We also stated in the CY 2020
ESRD PPS final rule (84 FR 60690 through 60691) that we would establish
a workgroup of CMS medical and other staff to review the materials
submitted as part of the TPNIES application, public comments, FDA
marketing authorization, and HCPCS application information and assess
the extent to which the product provides substantial clinical
improvement over current technologies.
In the CY 2020 ESRD PPS final rule, we established Sec. 413.236(d)
to provide a payment adjustment for a new and innovative renal dialysis
equipment or supply. We stated that the TPNIES is paid for 2-calendar
years. Following payment of the TPNIES, the ESRD PPS base rate will not
be modified and the new and innovative renal dialysis equipment or
supply will become an eligible outlier service as provided in Sec.
413.237.
Regarding the basis of payment for the TPNIES, in the CY 2020 ESRD
PPS final rule, we finalized at Sec. 413.236(e) that the TPNIES is
based on 65 percent of the price established by the MACs, using the
information from the invoice and other specified sources of
information.
In the CY 2021 ESRD PPS final rule (85 FR 71410 through 71464), we
made several changes to the TPNIES eligibility criteria at Sec.
413.236. First, we revised the definition of new at Sec. 413.236(b)(2)
as within 3 years beginning on the date of the FDA marketing
authorization. Second, we changed the deadline for TPNIES applicants'
HCPCS Level II code application submission from September 1 of the
particular calendar year to the HCPCS Level II code application
deadline for biannual Coding Cycle 2 for durable medical equipment,
orthotics, prosthetics, and supplies (DMEPOS) items and services as
specified in the HCPCS Level II coding guidance on the CMS website
prior to the calendar year. In addition, a copy of the applicable FDA
marketing authorization must be submitted to CMS by the HCPCS Level II
code application deadline for biannual Coding Cycle 2 for DMEPOS items
and services as specified in the HCPCS Level II coding guidance on the
CMS website in order for the equipment or supply to be eligible for the
TPNIES the following year. Third, we revised Sec. 413.236(b)(5) to
remove a reference to related guidance on the substantial clinical
improvement criterion, as the guidance had already been codified.
Finally, in the CY 2021 ESRD PPS final rule, we expanded the TPNIES
policy to include certain capital-related assets that are home dialysis
machines when used in the home for a single patient. We explained that
capital-related assets are defined in the Provider Reimbursement Manual
(chapter 1, section 104.1) as assets that a provider has an economic
interest in through ownership (regardless of the manner in which they
were acquired). We noted that examples of capital-related assets for
ESRD facilities are dialysis machines and water purification systems.
We explained that, although we stated in the CY 2020 ESRD PPS proposed
rule (84 FR 38354) that we did not believe capital-related assets
should be eligible for additional payment through the TPNIES because
the cost of these items is captured in cost reports, they depreciate
over time, and are generally used for multiple patients, there were a
number of other factors we considered that led us to consider expanding
eligibility for these technologies in the CY 2021 ESRD PPS

[[Page 61889]]

rulemaking. We explained that, following publication of the CY 2020
ESRD PPS final rule, we continued to study the issue of payment for
capital-related assets under the ESRD PPS, taking into account
information from a wide variety of stakeholders and recent developments
and initiatives regarding kidney care. For example, we considered
various HHS home dialysis initiatives, Executive Orders to transform
kidney care, and how the risk of COVID-19 for particularly vulnerable
ESRD beneficiaries could be mitigated by encouraging home dialysis.
After closely considering these issues, we proposed a revision to
Sec. 413.236(b)(6) in the CY 2021 ESRD PPS proposed rule to provide an
exception to the general exclusion for capital-related assets from
eligibility for the TPNIES for capital-related assets that are home
dialysis machines when used in the home for a single patient and that
meet the other eligibility criteria in Sec. 413.235(b), and finalized
the exception as proposed in the CY 2021 ESRD PPS final rule. We
finalized the same determination process for TPNIES applications for
capital-related assets that are home dialysis machines as for all other
TPNIES applications; that we will consider whether the new home
dialysis machine meets the eligibility criteria specified in Sec.
413.236(b) and announce the results in the Federal Register as part of
our annual updates and changes to the ESRD PPS. Per Sec. 413.236(c),
we will only consider, for additional payment using the TPNIES for a
particular calendar year, an application for a capital-related asset
that is a home dialysis machine received by February 1 prior to the
particular calendar year. If the application is not received by
February 1, the application will be denied and the applicant is able to
reapply within 3 years beginning on the date of FDA marketing
authorization in order to be considered for the TPNIES, in accordance
with Sec. 413.236(b)(2).
In the CY 2021 ESRD PPS final rule, at Sec. 413.236(f), we
finalized a pricing methodology for capital-related assets that are
home dialysis machines when used in the home for a single patient,
which requires the MACs to calculate the annual allowance and the
preadjusted per treatment amount. The pre-adjusted per treatment amount
is reduced by an estimated average per treatment offset amount to
account for the costs already paid through the ESRD PPS base rate. The
CY 2021 TPNIES offset amount was $9.32. We finalized that this amount
will be updated on an annual basis so that it is consistent with how
the ESRD PPS base rate is updated.
We revised Sec. 413.236(d) to reflect that we would pay 65 percent
of the pre-adjusted per treatment amount minus the offset for capital-
related assets that are home dialysis machines when used in the home
for a single patient.
We revised Sec. 413.236(d)(2) to reflect that following payment of
the TPNIES, the ESRD PPS base rate will not be modified and the new and
innovative renal dialysis equipment or supply will be an eligible
outlier service as provided in Sec. 413.237, except a capital-related
asset that is a home dialysis machine will not be an eligible outlier
service as provided in Sec. 413.237.
In summary, under the current eligibility requirements in Sec.
413.236(b), CMS provides for a TPNIES to an ESRD facility for
furnishing a covered equipment or supply only if the item: (1) Has been
designated by CMS as a renal dialysis service under Sec. 413.171; (2)
Is new, meaning within 3 years beginning on the date of the FDA
marketing authorization; (3) Is commercially available by January 1 of
the particular calendar year, meaning the year in which the payment
adjustment would take effect; (4) Has a complete HCPCS Level II code
application submitted in accordance with the HCPCS Level II coding
procedures on the CMS website, by the HCPCS Level II code application
deadline for biannual Coding Cycle 2 for DMEPOS items and services as
specified in the HCPCS Level II coding guidance on the CMS website
prior to the calendar year; (5) Is innovative, meaning it meets the
criteria specified in Sec. Sec. 412.87(b)(1); and (6) Is not a
capital-related asset, except for capital-related assets that are home
dialysis machines.
We received two applications for the TPNIES for CY 2022. One
applicant, CloudCath (the applicant for the CloudCath Peritoneal
Dialysis Drain Set Monitoring System), withdrew its application from
consideration after the issuance of the CY 2022 ESRD PPS proposed rule
because it did not receive FDA marketing authorization by July 6, 2021,
which was the HCPCS Level II code application deadline for biannual
Coding Cycle 2 for DMEPOS items and services. Under Sec. Sec.
413.236(c), an applicant for the TPNIES must receive FDA marketing
authorization for its new equipment or supply by the HCPCS Level II
Code application deadline for biannual Coding Cycle 2 for DMEPOS items
and services as specified in the HCPCS Level II coding guidance on the
CMS website prior to the particular calendar year. Therefore, the
CloudCath Peritoneal Dialysis Drain Set Monitoring System is not
eligible for consideration for the TPNIES for CY 2022. We are not
including in this final rule the description and discussion of this
application, which was included in the CY 2022 ESRD PPS proposed rule.
We note that we received public comments on the application that was
withdrawn. However, because the application was withdrawn and thus the
technology is ineligible for the TPNIES for CY 2022, we are not
summarizing nor responding to public comments regarding the TPNIES
criteria for this technology in this final rule. A discussion of the
remaining application, which met this deadline, is presented in this
final rule.
The application discussed in this final rule is for a technology
commonly used for the treatment of ESRD: Hemodialysis (HD). A detailed
definition for HD is included in Chapter 11, Section 10 of the Medicare
Benefits Policy Manual (Pub. L. 100-02).\2\ In brief, HD is a process
that involves blood passing through an artificial kidney machine and
the waste products diffusing across a manmade membrane into a bath
solution known as dialysate after which the cleansed blood is returned
to the patient's body. HD is accomplished usually in 3 to 5 hour
sessions, 3 times a week.
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\2\ Medicare Benefits Policy Manual (Pub. L. 100-102), available
at: <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c11.pdf">https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c11.pdf</a>.
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a. Tablo[supreg] System
Outset Medical, Inc. submitted an application for the TPNIES for
the Tablo[supreg] System for CY 2022. According to the applicant, the
technology is an HD machine that has been designed for patient-driven
self-care and to minimize system training time. The applicant stated
that the system is intended to substantially improve the treatment of
people with ESRD by removing barriers to home dialysis. The applicant
explained that the Tablo[supreg] System is comprised of (1) the
Tablo[supreg] Console with integrated water purification, on-demand
dialysate production, and a touchscreen interface; (2) a proprietary,
disposable, single-use pre-strung cartridge; and (3) the Tablo[supreg]
Connectivity and Data Ecosystem. Per the applicant, the system is built
to function in a connected setting with cloud-based system monitoring,
patient analytics and clinical recordkeeping.
The applicant stated that the Tablo[supreg] System's features
combine to provide a significantly differentiated HD solution with many
benefits. First, the applicant stated that the Tablo[supreg] System's
touchscreen interface made it easy to learn and use, guiding users
through treatment using step-by-step

[[Page 61890]]

instructions with simple words and animation. The applicant also stated
that instructions include non-technical language and color-coded parts
to enable easier training, faster set-up, and simpler management
including clear alarm explanations and resolution instructions.
Second, the applicant stated that the Tablo[supreg] System can
accommodate treatments at home, allowing for flexibility in treatment
frequencies, durations, and flow rates. Per the applicant, the
Tablo[supreg] System did not have a pre-configured dialyzer, which
allows clinicians to use a broad range of dialyzer types and
manufactures, allowing for greater customization of treatment for the
patient. The applicant stated that this was an improvement over the
incumbent home device, which requires a separate device component and
complex process to switch to another dialyzer.
Third, the applicant stated that the Tablo[supreg] System is an
all-in-one system with integrated water purification and on-demand
dialysate production, eliminating the need for industrial water
treatment rooms that are required to operate traditional HD machines.
The applicant also stated that electronic data capture and automatic
wireless transmission eliminate the need for manual record keeping by
the patient, care partner, or nurse. Per the applicant, a single-use
Tablo[supreg] Cartridge with pre-strung blood, saline, and infusion
tubing and a series of sensor-receptors mounted to an organizer snaps
into the system, minimizing difficult connections that require
additional training. The applicant stated that automated features,
including an integrated blood pressure monitor, air removal, priming,
and blood return, minimize user errors, save time, and streamline the
user experience.
Fourth, the applicant stated that the Tablo[supreg] System's two-
way wireless connectivity and data analytics provide the ability to
continuously activate new capabilities and enhancements through
wireless software updates, while also enabling predictive preventative
maintenance to maximize machine uptime.
The applicant stated that currently 88 percent of patients receive
HD in a clinic 3 times per week, for 3.0 to 4.5 hours a day and fewer
than 2 percent perform HD treatment at home.\3\ The applicant stated
that 25 to 36 percent of home HD patients return to in-center care
within 1 year of initiating HD at home.4 5 Per the
applicant, barriers to home dialysis adoption and retention have been
well studied and include treatment burden for patients and care partner
fatigue; technical challenges with operating a HD machine; space, home
modifications, and supplies management; patients not wanting medical
equipment in the home; and safety concerns.6 7
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\3\ United States Renal Data System. 2020 USRDS Annual Data
Report: Epidemiology of kidney disease in the United States, End-
Stage Renal Disease Chapter 2. National Institutes of Health,
National Institute of Diabetes and Digestive and Kidney Diseases,
Bethesda, MD 2020. Available at: <a href="https://adr.usrds.org/2020/end-stage-renaldisease/introduction-to-volume-2">https://adr.usrds.org/2020/end-stage-renaldisease/introduction-to-volume-2</a>. Accessed on Jan. 21,
2021.
\4\ Seshasai, R.K., et al. (2019). The home hemodialysis patient
experience: A qualitative assessment of modality use and
discontinuation. Hemodialysis International, 23: 139-150, 2019.
doi:10.1111/hdi.12713.
\5\ Weinhandl, Eric D., Collins Allan, Incidence of Therapy
Cessation among Home Hemodialysis Patients in the United States,
Abstract presented, American Society of Nephrology Kidney Week 2016.
\6\ Seshasai, R.K., et al (2019). The home hemodialysis patient
experience: A qualitative assessment of modality use and
discontinuation. Hemodialysis International, 23: 139-150, 2019.
doi:10.1111/hdi.12713.
\7\ Chan, Christopher T. et al. (2018). Exploring Barriers and
Potential Solutions in Home Dialysis: An NKF-KDOQI Conference
Outcomes Report American Journal of Kidney Diseases, Volume 73,
Issue 3, 363-371.
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The applicant stated that innovation in making home dialysis more
accessible to patients has been lacking due to a lack of investment
funding, limited incremental reimbursement for new technology, and a
consolidated, price-sensitive dialysis provider market where the lack
of market competition is costly and has been associated with increased
hospitalizations in dialysis patients.\8\ The applicant stated that the
Tablo[supreg] System was designed to address many system-related
barriers that result in patients deciding on in-center care and/or
stopping home modalities due to the burden of self-managed therapy.
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\8\ Erickson, K.F., Zheng, Y., Ho, V., Winkelmayer, W.C.,
Bhattacharya, J., & Chertow, G.M. (2018). Market Competition and
Health Outcomes in Hemodialysis. Health services research, 53(5),
3680-3703. <a href="https://doi.org/10.1111/1475-6773.12835">https://doi.org/10.1111/1475-6773.12835</a>.
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The applicant stated that while peritoneal dialysis (PD), like HD,
removes excess fluid and waste from the body, it has a different
mechanism of action and relies on the body's own membrane, the
peritoneum, to act as the ``dialyzer''. Per the applicant, PD requires
surgical placement of a catheter in the abdomen and utilizes a
cleansing fluid, dialysate, that must be infused and dwell in the
abdomen to remove waste products from the blood. The applicant stated
that PD must be conducted daily to achieve adequate dialysis and can be
conducted manually or via a cycler; while in contrast, HD directly
cleanses the blood with the use of a HD machine, dialysate and a
dialyzer, which acts as an artificial kidney in removing excess fluid
and toxins. The applicant stated that HD also requires surgical
placement of a dialysis access, which is usually in the form of a
catheter or a more permanent arteriovenous fistula.\9\
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\9\ Blake, P.G., Quinn, R.R., & Oliver, M.J. (2013). Peritoneal
dialysis and the process of modality selection. Peritoneal dialysis
international: Journal of the International Society for Peritoneal
Dialysis, 33(3), 233-241. <a href="https://doi.org/10.3747/pdi.2012.00119">https://doi.org/10.3747/pdi.2012.00119</a>.
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The applicant asserted that PD is the dominant home therapy used
around the world, but should not be solely relied upon to increase
growth in home dialysis, as there are physiological
contraindications.\10\ The applicant also stated that there is recent
evidence that post 90-day mortality is higher in PD patients than in HD
patients. Per the applicant, multivariable risk-adjusted analyses
demonstrated that the mortality hazard ratio of HD versus PD is 0.74
(95 percent confidence interval (CI), 0.68-0.80) in the 270 to 360-day
period after starting dialysis.\11\ The applicant stated that patients
and clinicians should weigh the risks and benefits of both options and
select the one that meets the individual patient's preferences, goals,
values and physiology. Per the applicant, because PD relies on the
patient's own membrane, physiologic changes can occur and result in
patients who are unable to continue PD due to loss of the ability to
achieve adequacy. The applicant stated that these home patients could
consider home HD rather than a return to in-center and noted that the
practice of transitioning from one home modality to another is
acknowledged by experts to be underutilized and is particularly
pronounced in the U.S., where the ratio of PD use to home HD is
6:1,\12\ as compared to 4:1 in Canada.\13\
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\10\ Ibid.
\11\ Mukhopadhyay, P., Woodside, K.J., Schaubel, D.E., Repeck,
K., McCullough, K., Shahinian, V.B., . . . & Saran, R. (2020).
Survival among incident peritoneal dialysis versus hemodialysis
patients who initiate with an arteriovenous fistula. Kidney
Medicine, 2(6), 732-741.
\12\ United States Renal Data System. 2020 USRDS Annual Data
Report: Epidemiology of kidney disease in the United States, End-
Stage Renal Disease Chapter 2. National Institutes of Health,
National Institute of Diabetes and Digestive and Kidney Diseases,
Bethesda, MD 2020. Available at: <a href="https://adr.usrds.org/2020/end-stage-renaldisease/introduction-to-volume-2">https://adr.usrds.org/2020/end-stage-renaldisease/introduction-to-volume-2</a>. Accessed on Jan 21,
2021.
\13\ Canada Institute for Health Information (2020): Annual
Statistics. Available at: <a href="https://secure.cihi.ca/estore/productSeries.htm?locale=en&pc=PCC24&_ga=2.265337481.729263172.1612199530-510791291.1610562424">https://secure.cihi.ca/estore/productSeries.htm?locale=en&pc=PCC24&_ga=2.265337481.729263172.1612199530-510791291.1610562424</a>. Accessed on Jan. 31, 2021.

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[[Page 61891]]

The applicant asserted that the Tablo[supreg] System presented a
significant clinical improvement over NxStage[supreg] System
OneTM (NxStage[supreg]), the current standard of home HD
care, with the goal of getting patients access to easier to use
technology and increasing the number of patients who can do dialysis at
home. Per the applicant, NxStage[supreg] is the only other mobile HD
machine that is approved for home use.
(1) Renal Dialysis Service Criterion (Sec. 413.236(b)(1))
With respect to the first TPNIES eligibility criterion under Sec.
413.236(b)(1), whether the item has been designated by CMS as a renal
dialysis service under Sec. 413.171, maintenance dialysis treatments
and all associated services, including historically defined dialysis-
related drugs, laboratory tests, equipment, supplies, and staff time,
were included in the composite rate for renal dialysis services as of
December 31, 2010 (75 FR 49036). An in-home HD machine would be
considered equipment essential for the provision of maintenance
dialysis. We received no public comments on whether the Tablo[supreg]
System meets this criterion. Based on its status as an in-home HD
machine, we consider the Tablo[supreg] System to be a renal dialysis
service under Sec. 413.171.
(2) Newness Criterion (Sec. 413.236(b)(2))
With respect to the second TPNIES eligibility criterion under Sec.
413.236(b)(2), whether the item is new, meaning within 3 years
beginning on the date of the FDA marketing authorization, the applicant
indicated that the Tablo[supreg] System received FDA marketing
authorization for home use on March 31, 2020.\14\ We received no public
comments on whether the Tablo[supreg] System meets the newness
criterion. Based on the information provided by the applicant, we agree
that the Tablo[supreg] System meets the newness criterion.
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\14\ As we stated in the CY 2022 ESRD PPS proposed rule (86 FR
36334), in reviewing the enclosure to which the March 31, 2020 FDA
authorization letter refers, the applicant's Section 510(k)
submission indicated that the Tablo[supreg] Cartridge was reviewed
separately from the Tablo[supreg] System and has its own separate
510(k) clearance. We further stated that, in the CY 2021 ESRD PPS
final rule, CMS determined that the cartridge did not meet the
newness criterion for the TPNIES (85 FR 71464) and as such, the
cartridge was not new.
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(3) Commercial Availability Criterion (Sec. 413.236(b)(3))
With respect to the third eligibility criterion under Sec.
413.236(b)(3), whether the item is commercially available by January 1
of the particular calendar year, meaning the year in which the payment
adjustment would take effect, applicant indicated that the
Tablo[supreg] System became available for home use on April 1, 2020. We
received no public comments on whether the Tablo[supreg] System meets
the commercial availability criterion. Based on the information
provided by the applicant, we agree that the Tablo[supreg] System meets
the commercial availability criterion.
(4) HCPCS Level II Application Criterion (Sec. 413.236(b)(4))
The fourth TPNIES eligibility criterion, under Sec. 413.236(b)(4),
is whether the applicant has submitted a complete HCPCS Level II code
application in accordance with the HCPCS Level II coding procedures on
the CMS website, by the HCPCS Level II code application deadline for
biannual Coding Cycle 2 for DMEPOS items and services as specified in
the HCPCS Level II coding guidance on the CMS website prior to the
particular calendar year. The applicant indicated that it submitted a
HCPCS Level II code application on July 6, 2021, which was same day as
the deadline specified HCPCS Level II code application deadline for
biannual Coding Cycle 2 for DMEPOS items and services specified in CMS
guidance.\15\ We received no public comments on whether the
Tablo[supreg] System meets this criterion. Based on the information
provided by the applicant, we agree the applicant has met the HCPCS
Level II application criterion.
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\15\ <a href="https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/2020-HCPCS-Application-and-Instructions.pdf">https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/2020-HCPCS-Application-and-Instructions.pdf</a>.
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(5) Innovation Criterion (Sec. Sec. 413.236(b)(5) and 412.87(b)(1))
With respect to the fifth TPNIES eligibility criterion under Sec.
413.236(b)(5), that the item is innovative, meaning it meets the
substantial clinical improvement criteria specified in Sec.
412.87(b)(1), the applicant claimed that the Tablo[supreg] System
significantly improves clinical outcomes relative to the current
standard of care for home HD services, which it identified as the
incumbent NxStage[supreg] home dialysis machine. The applicant
presented the following substantial clinical improvement claims: (1)
Decreased treatment frequency with adequate dialysis clearance; (2)
increased adherence to dialysis treatment and retention to home
therapy; and (3) improved patient quality of life. The applicant
supported these claims with the Tablo[supreg] System Investigational
Device Exemption (IDE) Study \16\ and secondary support from four
papers 17 18 19 20 and two posters.21 22 The
applicant also provided comparison data from three studies directly
related to the incumbent 23 24 25 and an additional study
that, based on the timeframe of the study, likely involved participants
undergoing treatment with NxStage[supreg] although the article does not
directly reference the incumbent.\26\
---------------------------------------------------------------------------

\16\ <a href="http://Clinicaltrials.gov">Clinicaltrials.gov</a> website. <a href="https://www.clinicaltrials.gov/ct2/show/NCT02460263">https://www.clinicaltrials.gov/ct2/show/NCT02460263</a>. Last Updated July 1, 2020. <a href="https://www.clinicaltrials.gov/ProvidedDocs/63/NCT02460263/Prot_000.pdf">https://www.clinicaltrials.gov/ProvidedDocs/63/NCT02460263/Prot_000.pdf</a>.
\17\ Chertow, G.M., Alvarez, L., Plumb, T.J., Prichard, S.S., &
Aragon, M. (2020). Patient-reported outcomes from the
investigational device exemption study of the Tablo hemodialysis
system. Hemodialysis International, 24(4), 480-486.
\18\ Leypoldt, J.K., Prichard, S., Chertow, G.M., & Alvarez, L.
(2019). Differential molecular modeling predictions of mid and
conventional dialysate flows. Blood purification, 47(4), 369-376.
\19\ Safety and efficacy of the Tablo hemodialysis system for
in-center and home hemodialysis Plumb, T.J., Alvarez, L., Ross,
D.L., Lee, J.J., Mulhern, J.G., Bell, J.L., Abra, G., Prichard,
S.S., Chertow, G.M. and Aragon, M.A. (2019), Hemodialysis
International.
\20\ Plumb, Troy J., Luis Alvarez, Dennis L. Ross, Joseph J.
Lee, Jeffrey G. Mulhern, Jeffrey L. Bell, Graham E. Abra, Sarah S.
Prichard, Glenn M. Chertow, and Michael A. Aragon. ``Self-care
training using the Tablo hemodialysis system.'' Hemodialysis
International (2020).
\21\ Alvarez, Luis et al. Urea Clearance Results in Patients
Dialyzed Thrice-weekly Using a Dialysate Flow of 300 mL/min,
clinical abstract, presented March 2019, Annual Dialysis Conference,
Dallas, TX.
\22\ Chahal, Y., Plumb, T., Aragon M. (2020). Patient Device
Preference for Home Hemodialysis: A Subset Analysis of the Tablo
Home IDE Trial. Poster Presentation at National Kidney Foundation
Spring Clinical Conference, March 2020.
\23\ Kraus, M., et al, A comparison of center-based vs. home-
based daily hemodialysis for patients with end-stage renal disease.
Hemodialysis International, 11: 468-477, (2007).
\24\ Finkelstein, F.O., et al. (2012). At-home short daily
hemodialysis improves the long-term health-related quality of life.
Kidney international, 82(5), 561-569.
\25\ Weinhandl, E.D., Gilbertson, D.T., & Collins, A.J. (2016).
Mortality, hospitalization, and technique failure in daily home
hemodialysis and matched peritoneal dialysis patients: A matched
cohort study. American Journal of Kidney Diseases, 67(1), 98-110.
\26\ Suri, R.S., Li, L., & Nesrallah, G.E. (2015). The risk of
hospitalization and modality failure with home dialysis. Kidney
international, 88(2), 360-368.
---------------------------------------------------------------------------

We provided an overview of these ten sources in the CY 2022 ESRD
PPS proposed rule (86 FR 36333 through 36343), followed by the
applicant's summary of how the data support each claim of substantial
clinical improvement.\27\ We also included in the CY 2022 ESRD PPS
proposed rule a discussion of how we were applying the requirements of
Sec. 413.236(b)(5) to our review of the application and a summary of
our preliminary concerns.

[[Page 61892]]

We stated that we did not include detailed summaries of the remaining
supplemental content included with the application. Specifically, the
applicant submitted numerous supplemental background materials related
to the dialysis industry, reimbursement patterns, modalities, treatment
frequencies, patient adherence, hospitalization rates, and quality of
life. The applicant also submitted several letters of support for the
Tablo[supreg] System; three from dialysis patients, three from
nephrologists, and one from a dialysis clinic nurse. These letters
emphasized benefits of the Tablo[supreg] System, including reduced
frequency of dialysis treatment, improved home dialysis retention,
reduced patient and caregiver burden, reduced patient fatigue, and
improved patient quality of life.
---------------------------------------------------------------------------

\27\ 86 FR 36335-36342.
---------------------------------------------------------------------------

(a) Applicant Substantial Clinical Improvement Sources
As we discussed in the CY 2022 ESRD PPS proposed rule (86 FR
36335), the applicant's primary support for its three substantial
clinical improvement claims came from a prospective, multicenter, open-
label, non-randomized crossover study that compared in-center and in-
home HD performance using the Tablo[supreg] System. Per the applicant,
this study is referred to as the Tablo[supreg] System Investigational
Device Exemption (IDE) Study and the original study protocol and
amendments were approved by FDA and registered on <a href="http://www.clinicaltrials.gov">http://www.clinicaltrials.gov</a> as ID: NCT02460263. The applicant stated that of
the 30 participants enrolled (17 White and 13 Black or African
American), 28 (18 men and 10 women) completed the study. Thirteen of
the participants had previous home HD experience with NxStage[supreg],
and the remainder had previously received conventional in-center HD
care. The applicant also noted that the Tablo[supreg] System IDE study
sample was comprised of a representative cohort of dialysis patients
and reported that it was similar to the population studied for the IDE
study for the incumbent NxStage[supreg]. As described in the study
protocol, the primary and secondary efficacy endpoints were a
standardized weekly Kt/V of greater than or equal to 2.1 and
ultrafiltration (fluid removal) value as reported by the device within
ten percent of the expected fluid removal based on the ultrafiltration
prescription and the Tablo[supreg] System Console fluid removal
algorithm, respectively.\28\ We clarified in the CY 2022 ESRD PPS
proposed rule that Kt/V is a value used to quantify dialysis treatment
adequacy and ``K'' = dialyzer clearance, ``t'' = time, and ``V'' =
Volume of distribution of urea. The applicant stated that each study
participant served as his or her own control and remained in the trial
for approximately 21 weeks, during which time they were prescribed HD
with the Tablo[supreg] System on a 4 times per week schedule. The
applicant explained that the trial consisted of 4 treatment periods:
(1) A 1 week, in-center run-in period; (2) an in-center period of 32
treatments (approximately 8 weeks) during which ESRD facility staff
managed the dialysis treatments; (3) a transition period of up to 4
weeks to train the patient and care partner in managing the dialysis;
and (4) a final in-home period of 32 treatments (approximately 8
weeks).
---------------------------------------------------------------------------

\28\ <a href="http://Clinicaltrials.gov">Clinicaltrials.gov</a> website. <a href="https://www.clinicaltrials.gov/ct2/show/NCT02460263">https://www.clinicaltrials.gov/ct2/show/NCT02460263</a>. Last Updated July 1, 2020. <a href="https://www.clinicaltrials.gov/ProvidedDocs/63/NCT02460263/Prot_000.pdf">https://www.clinicaltrials.gov/ProvidedDocs/63/NCT02460263/Prot_000.pdf</a>.
---------------------------------------------------------------------------

With respect to the applicant's secondary sources of support, a
poster presentation from Alvarez, et al., presented dialysis adequacy
data collected from a retrospective review of 29 patients' (18 males,
11 females and 17 percent Black, 10 percent Hispanic) dialysis records.
The study compared Kt/V results of patients aged 34-84 receiving
dialysis using the Tablo[supreg] System to patients receiving dialysis
from a conventional HD machine. The majority of patients used a fistula
or graft (59 percent fistula, 28 percent graft, 10 percent catheter).
One hundred ninety two dialysis treatments were conducted on a thrice-
weekly schedule using the Tablo[supreg] System with a dialysate flow
rate of 300 mL per minute. A single pool Kt/V of greater than 1.2 was
achieved in 94 percent of treatments in patients less than 90 kg with
an average duration of treatment at 224 +/-29 minutes and in 79 percent
of treatments in patients greater than 90 kg with an average duration
of treatment at 249 +/-27 minutes. The average achieved Kt/V was 1.4 +/
-0.2 among treatments provided with the Tablo[supreg] System. Eighty-
eight treatments were conducted using a conventional HD machine with a
dialysate flow rate of 500 mL per minute. A single pool Kt/V of greater
than 1.2 was achieved in 93 percent of treatments in patients less than
90 kg with an average duration of treatment at 227 +/-21 minutes and in
83 percent of treatments in patients greater than 90 kg with an average
duration of treatment at 249 +/-14 minutes. The average achieved Kt/V
was 1.6 +/-0.4 among the conventional HD treatments.\29\
---------------------------------------------------------------------------

\29\ Alvarez, Luis et al. Urea Clearance Results in Patients
Dialyzed Thrice-weekly Using a Dialysate Flow of 300 mL/min,
clinical abstract, presented March 2019, Annual Dialysis Conference,
Dallas, TX.
---------------------------------------------------------------------------

Next, an article from Chertow, et al., described additional data
from the Tablo[supreg] System IDE study (discussed previously),
including health-related quality of life, to further assess the safety
of home HD with the Tablo[supreg] System. Demographic information
identified the mean age as 49.8 + 13 years, 62 percent male, 62 percent
White, 38 percent Black or African American, 23 percent Hispanic or
Latino, 68 percent Not Hispanic or Latino, and 8 percent not reported,
among patients established on home HD. Among the patients new to home
HD, the mean age was identified as 54.2 + 10.4 years, 65 percent male,
53 percent White, 47 percent Black or African American, 29 percent
Hispanic or Latino, 71 percent Not Hispanic or Latino, and 0 percent
not reported. Twenty-eight of 30 patients (93 percent) completed all
trial periods. Adherence to the prescribed 4 treatments per week
schedule was 96 percent in-center and 99 percent in-home. The median
time to recovery was 1.5 hours during the in-center and 2 hours during
the at-home phase of the trial. Median index values on the 5-level
EuroQol-5 Dimension (EQ-5D-5L) (a self-assessed, health related,
quality of life questionnaire) were similar during the in-center as
compared to in-home dialysis at 0.832 and 0.826, respectively. Patients
new to home HD had lower median values (0.751) for both in-center and
in-home periods. Patients who had used home dialysis prior to the trial
had higher median values during both in-center (0.903) and in-home
(0.906) periods. Patients reported feeling alert or well-rested with
little difficulty falling or staying asleep or feeling tired and worn
out when using the Tablo[supreg] System in either environment. The
authors concluded that when using the Tablo[supreg] System in-home,
patients reported similar time to recovery, general health status, and
sleep quality compared to using the Tablo[supreg] System in-center.\30\
---------------------------------------------------------------------------

\30\ Chertow, G.M., Alvarez, L., Plumb, T.J., Prichard, S.S., &
Aragon, M. (2020). Patient-reported outcomes from the
investigational device exemption study of the Tablo hemodialysis
system. Hemodialysis International, 24(4), 480-486.
---------------------------------------------------------------------------

Next, an article from Leypoldt, et al., described the use of uremic
solute kinetic models to assess dialysis adequacy via theoretical
single pool Kt/V levels when varying the dialysis blood flow rates and
the patient urea volume of distribution. A comparison was made between
dialysate flows of 300 and 500 mL/min at blood flows of both 300 and
400 mL/min. The patient urea volume of

[[Page 61893]]

distribution range modeled by the authors ranged from 25 to 45 L. Under
ideal conditions, the authors demonstrated that with a blood flow of
300 mL per minute, a single pool Kt/V of greater than 1.2 could be
achieved in patients with a urea volume of distribution of 35 L and 240
minutes of dialysis. Patients with a urea volume of distribution of 40
L would require 255 minutes of dialysis. Patients with a urea volume of
distribution of 45 L would require over 270 minutes of dialysis. With a
blood flow of 400 mL per minute, patients with a urea volume of
distribution of 40 L could achieve the target single pool Kt/V of
greater than 1.2 with 240 minutes of dialysis. Patients with a volume
of distribution of 45 L could achieve the target with 270 minutes of
dialysis. The authors did not model urea kinetics for patients with
volumes of distribution greater than 45 L.\31\
---------------------------------------------------------------------------

\31\ Leypoldt, J.K., Prichard, S., Chertow, G.M., & Alvarez, L.
(2019). Differential molecular modeling predictions of mid and
conventional dialysate flows. Blood purification, 47(4), 369-376.
---------------------------------------------------------------------------

Next, an article by Plumb, et al., described the Tablo[supreg]
System IDE study (discussed previously). Demographic information
reflected the mean age as 52.3 + 11.6 years, 19 men and the following
racial and ethnic representation: 17 White, 13 Black or African
American, 8 Hispanic or Latino, and 21 Not Hispanic or Latino.
Comparisons among the 28 patients in this study and subsequent
secondary analyses were either made between the 8 weeks of using the
Tablo[supreg] System for in-center HD and the 8 weeks of the
Tablo[supreg] System for in-home HD or between using the Tablo[supreg]
System in-home HD and the treatment provided prior to study enrollment.
In both settings, patients dialyzed using the Tablo[supreg] System 4
times per week. The primary efficacy endpoint was achievement of a
weekly standard Kt/V greater than or equal to 2.1 in both the 8-week
in-center phase of the study and the 8-week in-home phase of the study.
This endpoint was achieved in 199 of 200 weeks in the in-center
dialysis period and in 168 of 171 weeks in the in-home dialysis period.
The primary safety endpoint of adverse event rates were similar at 1.9
percent in the in-center dialysis period and 1.8 percent in the in-home
dialysis period. The secondary efficacy endpoint was whether the
ultrafiltration volume and rate achieved the prescribed levels. In both
in-center and in-home dialysis, 94 percent of treatments achieved
successful delivery of ultrafiltration, defined as a rate within ten
percent of the prescribed value. Of 960 in-center dialysis services and
896 in-home dialysis services, 922 and 884 were completed respectively,
yielding adherence rates of 96 percent and 99 percent.\32\
---------------------------------------------------------------------------

\32\ Safety and efficacy of the Tablo hemodialysis system for
in-center and home hemodialysis Plumb, T.J., Alvarez, L., Ross,
D.L., Lee, J.J., Mulhern, J.G., Bell, J.L., Abra, G., Prichard,
S.S., Chertow, G.M. and Aragon, M.A. (2019), Hemodialysis
International.
---------------------------------------------------------------------------

Next, a separate article by Plumb et al., reported additional data
from the Tablo[supreg] System IDE study (previously discussed)
regarding participants' assessment of the Tablo[supreg] System's ease-
of-use, the degree of dependence on health care workers and caregivers
after training with the system was complete, and the training time
required for a participant to be competent in self-care. Demographic
information reflected the mean age as 52.6 years, 18 men, 10 women, 16
White, 7 Hispanic or Latino, 9 Not Hispanic or Latino, and 12 Black or
African American. Participants were stratified according to whether
they were previously on self-care dialysis at home or conventional in-
center HD. Thirteen participants had previous experience performing
self-care HD. The remaining 15 participants had previous experience
with in-center HD only. All participants rated the Tablo[supreg]
System's setup, treatment, and takedown on a scale from 1 (very
difficult) to 5 (very simple) and indicated whether they had required
assistance with treatment over the prior 7 days. Set up times were
similar regardless of whether the participants were previously on self-
care HD or conventional in-center HD. For the participants previously
on in-center HD, the average set up time for the concentrates was 0.93
minutes and for the cartridge, 9.35 minutes. For participants
previously on self-care home HD, the average set up time for the
concentrates was 1.22 minutes and for the cartridge, 10.28 minutes. The
average rating of the Tablo[supreg] System's ease of use for setup was
4.5, treatment 4.6, and take down 4.6 among the participants previously
on self-care home HD. In comparison, based on recollection (not based
on rating during time of use) these participants' average rating of
their previous device's ease of use for setup was 3.5, treatment 3.3,
and take down 3.8. The average rating of the Tablo[supreg] System's
ease of use for setup and treatment was 4.6 and 4.7 for take down among
participants without prior self-care experience.
Among patients surveyed, caregiver assistance was required in 62
percent of patient-weeks during home self-care. Participants previously
on self-care home HD required some caregiver assistance in 42 percent
of the in-home dialysis treatment weeks. Participants previously on
conventional in-center dialysis required some caregiver assistance in
35 percent of the in-home dialysis treatment weeks. The requirement for
some form of assistance among participants with or without previous
self-care experience was not meaningfully different. Finally, the
authors noted that a protocol amendment allowed for the recording of
the number of training sessions necessary to deem a patient competent
to do self-care dialysis. This recording was limited to the last 15
participants enrolled into the study. Five of these participants had
previous self-care dialysis at home experience. The average number of
training sessions required to be deemed competent was 3.6 for
participants with previous self-care dialysis at home experience and
3.9 sessions for participants with only conventional in-center HD
experience.\33\
---------------------------------------------------------------------------

\33\ Plumb, Troy J., Luis Alvarez, Dennis L. Ross, Joseph J.
Lee, Jeffrey G. Mulhern, Jeffrey L. Bell, Graham E. Abra, Sarah S.
Prichard, Glenn M. Chertow, and Michael A. Aragon. ``Self-care
training using the Tablo hemodialysis system.'' Hemodialysis
International (2020).
---------------------------------------------------------------------------

Next, a poster presentation from Chahal, et al., reported patient
device preference of prior in-home HD patients based on data from the
Tablo[supreg] System IDE study (previously discussed). The authors
noted that 13 of the 30 participants in the Tablo[supreg] System IDE
trial were performing in-home HD at the time of enrollment and that
prior to the study, dialysis prescriptions averaged 4.5 treatments per
week with an average time of 3.1 hours per session. Trial prescriptions
were for 4 days per week and an average of 3.4 hours per session.
Adherence to the study regimen was 97 percent and 92 percent of surveys
were completed. The authors concluded that participants with prior home
HD experience preferred the Tablo[supreg] System compared to their
prior device and 85.6 percent found that the Tablo[supreg] System was
easier to use.\34\
---------------------------------------------------------------------------

\34\ Chahal, Y., Plumb, T., Aragon M. (2020). Patient Device
Preference for Home Hemodialysis: A Subset Analysis of the Tablo
Home IDE Trial. Poster Presentation at National Kidney Foundation
Spring Clinical Conference, March 2020.
---------------------------------------------------------------------------

As stated previously in the CY 2022 ESRD PPS proposed rule (86 FR
36337), the applicant submitted several sources pertaining to the
incumbent, NxStage[supreg]. First, an article from Kraus et al.,
described a feasibility study to demonstrate the safety of center-based
versus home-based daily HD with the NxStage[supreg] portable HD device.
This retrospective analysis examined the extent to which clinical
effects

[[Page 61894]]

previously associated with short-daily dialysis were also seen using
the NxStage[supreg] device. The authors conducted a prospective, two-
treatment, two-period, open-label, crossover study of in-center HD vs.
home HD in 32 patients treated at six U.S. centers. Demographic
information reflected the mean age as 51 years, 63 percent male, 38
percent female, 24 White, 6 Black or African American, 1 American
Indian or Alaskan native, and 1 Asian. The 8-week In-Center Phase (6
days/week) was followed by a 2-week transition period and then followed
by the 8-week Home Phase (6 days/week). Data was collected
retrospectively on HD treatment parameters immediately preceding the
study in a subset of patients. Twenty-six out of 32 patients (81
percent) successfully completed the study. Treatment compliance
(defined as completing 43 to 48 treatments in a given phase) was
comparable between the 2 treatment environments (88 percent In-Center
vs. 89 percent Home). Successful delivery of at least 90 percent of
prescribed fluid volume (primary endpoint) was achieved in 98.5 percent
of treatments in-center and 97.3 percent at home. Total effluent volume
as a percentage of prescribed volume was between 94 percent and 100
percent for all study weeks. The composite rate of intradialytic and
interdialytic adverse events per 100 treatments was significantly
higher for the In-Center Phase (5.30) compared with the Home Phase
(2.10; p=0.007). Compared with the period immediately preceding the
study, there were reductions in blood pressure, antihypertensive
medications, and interdialytic weight gain. The study concluded that
daily home HD with a small, easy-to-use HD device is a viable dialysis
option for ESRD patients capable of self/partner administered
dialysis.\35\
---------------------------------------------------------------------------

\35\ Kraus, M., et al., A comparison of center-based vs. home-
based daily hemodialysis for patients with end-stage renal disease.
Hemodialysis International, 11: 468-477, (2007).
---------------------------------------------------------------------------

Second, an article from Finkelstein et al., reported on interim
results of the Following Rehabilitation, Economics and Everyday-
Dialysis Outcome Measurements (FREEDOM) study, a multi-center,
prospective, cohort study of at-home short daily HD with a planned 12-
month follow-up (ClinicalTrials.gov identifier, NCT00288613). Eligible
patients were adults with ESRD requiring dialysis who were being
initiated on short daily HD (prescribed 6 times per week) at home using
the NxStage[supreg] cycler and who had Medicare as their primary
insurance payer. The authors examined the long-term effect of short
daily HD on health-related quality of life, as measured by the Short
Form-36 (SF-36) health survey. The survey was administered at baseline,
4 and 12 months after initiation of short daily HD to 291 (total
cohort) participants. Demographic information reflected the mean age as
53 years, 66 percent male and 70 percent White. Of the 291
participants, 154 completed the 12-month follow-up (as-treated cohort).
In the total cohort analysis, both the physical- and mental-
component summary scores improved over the 12-month period, as did all
8 individual domains of the SF-36. The as-treated cohort analysis
showed similar improvements with the exception of the role-emotional
domain. Significantly, in the as-treated cohort, the percentage of
patients achieving a physical component summary score at least
equivalent to the general population more than doubled. The authors
concluded by noting that at-home short daily HD is associated with
long-term improvements in various physical and mental health-related
quality of life measures.\36\
---------------------------------------------------------------------------

\36\ Finkelstein, F.O., et al. (2012). At-home short daily
hemodialysis improves the long-term health-related quality of life.
Kidney International, 82(5), 561-569.
---------------------------------------------------------------------------

Third, in Weinhandl, et al., authors described a cohort study in
which 4,201 new home HD patients in 2007 were matched with 4,201 new PD
patients in 2010 from the United States Renal Data System (USRDS)
database to assess relative mortality, hospitalization, and technique
failure. Demographic information reflected the mean age as 53.8 + 14.9
years, 67 percent male, 33 percent female, 24.4 percent Black, and 75.6
percent Nonblack. Daily home HD patients initiated use of
NxStage[supreg] from 2007 through 2010. Authors reported home HD was
associated with 20 percent lower risk for all-cause mortality, 8
percent lower risk for all-cause hospitalization, and 37 percent lower
risk for technique failure, all relative to PD. Regarding
hospitalization, risk comparisons favored home HD for cardiovascular
disease and dialysis access infection and PD for bloodstream infection.
Authors noted that matching was unlikely to reduce confounding
attributable to unmeasured factors, including residual kidney function;
lack of data regarding dialysis frequency, duration, and dose in daily
home HD patients and frequency and solution in PD patients; and
diagnosis codes used to classify admissions. The authors concluded that
these data suggest that relative to PD, daily home HD is associated
with decreased mortality, hospitalization, and technique failure but
that risks for mortality and hospitalization were similar with these
modalities in new dialysis patients.\37\
---------------------------------------------------------------------------

\37\ Weinhandl, E.D., Gilbertson, D.T., & Collins, A.J. (2016).
Mortality, hospitalization, and technique failure in daily home
hemodialysis and matched peritoneal dialysis patients: a matched
cohort study. American Journal of Kidney Diseases, 67(1), 98-110.
---------------------------------------------------------------------------

Fourth, in Suri et al., 1116, daily home HD patients were matched
by propensity scores to 2,784, contemporaneous USRDS patients receiving
home PD. The authors compared hospitalization rates from
cardiovascular, infectious, access-related or bleeding causes, and
modality failure risk. Similar analyses were performed for 1,187, daily
home HD patients matched to 3,173, USRDS patients receiving in-center
conventional HD. Demographic information identified the mean age as
50.5 years, 67.3 percent male, 70.9 percent White, 26.6 percent Black,
and 2.5 percent Other, among the daily home HD patients. Among the home
PD patients, the mean age was identified as 50.9 years, 66.9 percent
male, 73.1 percent White, 25.1 percent Black and 1.2 percent Other. The
composite hospitalization rate was significantly lower with daily home
HD than with PD (0.93 vs. 1.35/patient-year). Daily home HD patients
spent significantly fewer days in the hospital than PD patients (5.2
vs. 9.2 days/patient-year), and significantly more daily home HD
patients remained admission-free (52 percent daily home dialysis vs. 32
percent PD). In contrast, there was no significant difference in
hospitalizations between daily home HD and conventional HD (0.93 vs.
1.10/patient-year). Cardiovascular hospitalizations were lower with
daily home HD than with conventional HD (0.68) while infectious and
access hospitalizations were higher (1.15) and 1.25 respectively).
Significantly more PD than daily home HD patients switched back to in-
center HD (44 percent vs. 15 percent). In this prevalent cohort, daily
home HD was associated with fewer admissions and hospital days than PD,
and a substantially lower risk of modality failure.\38\
---------------------------------------------------------------------------

\38\ Suri, R.S., Li, L., & Nesrallah, G.E. (2015). The risk of
hospitalization and modality failure with home dialysis. Kidney
International, 88(2), 360-368.
---------------------------------------------------------------------------

(b) Applicant Substantial Clinical Improvement Claims
Regarding the applicant's first claim that the Tablo[supreg] System
decreases treatment frequency with adequate

[[Page 61895]]

dialysis clearance, the applicant stated that the Tablo[supreg] System
is the only mobile HD device approved for use in the home that can
achieve adequate dialysis in as little as 3 treatments per week, while
also providing flexibility for more frequent dialysis and thus greater
personalization of care. The applicant stated that adequate dialysis
for a standard, thrice-weekly treatment schedule is a single treatment
clearance of urea, expressed as a single-pool Kt/V (spKt/V) of greater
than 1.2 where ``K'' = dialyzer clearance, ``t'' = time, and ``V'' =
Volume of distribution of urea. The applicant also stated that dialyzer
clearance, or ``K'', is dependent on the mass transfer coefficient
(KoA) characteristics of the prescribed dialyzer and prescribed blood
and dialysate flow rates. The applicant further noted that limitations
in ``K'' or ``t'' affect the ability of a patient to achieve adequate
clearance during a dialysis treatment. Per the applicant, across a
broad range of weights, patients using the Tablo[supreg] System can
achieve the target of dialysis adequacy, a single pool Kt/V of 1.2,
with 3 treatments per week in less than 4 hours.\39\ The applicant also
stated that when used 4 times per week, patients using the
Tablo[supreg] System had a higher mean weekly standard Kt/V with
equivalent or better dialysis-related hospitalization rates,\40\ as
compared to NxStage[supreg] IDE patients prescribed therapy at 6 days
per week.\41\
---------------------------------------------------------------------------

\39\ Alvarez, Luis et al. Urea Clearance Results in Patients
Dialyzed Thrice-weekly Using a Dialysate Flow of 300 mL/min,
clinical abstract, presented March 2019, Annual Dialysis Conference,
Dallas, TX.
\40\ Plumb, T.J., Alvarez, L., Ross, D.L., Lee, J.J., Mulhern,
J.G., Bell, J.L., Abra, G., Prichard, S.S., Chertow, G.M. and
Aragon, M.A. (2019). Safety and efficacy of the Tablo hemodialysis
system for in-center and home hemodialysis. Hemodialysis
International.
\41\ NxStage Clearance Calculator. Available at: <a href="https://dosingcalculator.nxstage.com/DosingCalculator/">https://dosingcalculator.nxstage.com/DosingCalculator/</a>. Accessed on Jan 21,
2021.
---------------------------------------------------------------------------

The applicant stated that the Tablo[supreg] System's on-demand
dialysate production has no limitation to the volume of dialysate that
can be produced and used during a single treatment. The applicant
further stated that this facilitates the delivery of adequate dialysis
clearance (Kt/V) in a standard duration and target frequency of 3 times
per week, as well as alternate frequencies and durations as preferred
by a patient or recommended by a health care provider.
The applicant asserted that NxStage,[supreg] when attached to its
PureFlowTM device, requires users to batch a set amount of
dialysate (maximum of 60 liters) in advance of a treatment or use
sterile dialysate bags (maximum of 30 liters). The applicant also
stated that at its maximum dialysate flow rate (Qd) of 300ml/min,
NxStage[supreg] greatly limits time by restricting treatment to a
maximum of 200 minutes before exhausting its dialysate capacity (200
min = 60L/300ml/min). The applicant stated that Dialysis Outcomes and
Practice Patterns Study (DOPPS) data demonstrate that the current U.S.
practice for thrice-weekly dialysis occurs at an average treatment time
of greater than 220 minutes, and has increased in the last 25
years.\42\ Per the applicant, with the limited ``t'', a single-pooled
Kt/V of >1.2 cannot be expected to be achieved for the majority of U.S.
patients with ESRD on a thrice-weekly schedule, requiring increased
treatment frequency \43\ at home for these patients to meet the desired
clearance level.
---------------------------------------------------------------------------

\42\ Tentori F, Zhang J, Li Y, Karaboyas A, Kerr P, Saran R,
Bommer J, Port F, Akiba T, Pisoni R, Robinson B. Longer dialysis
session length is associated with better intermediate outcomes and
survival among patients on in-center three times per week
hemodialysis: Results from the Dialysis Outcomes and Practice
Patterns Study (DOPPS). Nephrol Dial Transplant. 2012
Nov;27(11):4180-8. doi: 10.1093/ndt/gfs021. Epub 2012 Mar 19. PMID:
22431708; PMCID: PMC3529546.
\43\ Health Management Associates (HMA) analysis of 2018 100%
Medicare Outpatient file.
---------------------------------------------------------------------------

In citing Leypoldt, et al., the applicant stated that data from the
Hemodialysis (HEMO) trial combined with modeling results from Leypoldt,
et al.,\44\ allowed for an estimation of the patients with ESRD, based
on weight, that cannot be expected to achieve target clearance with
standard thrice-weekly dialysis at this treatment duration. The
applicant explained that because urea is evenly distributed throughout
a body's water, the volume of distribution of urea is equal to a
patient's total volume of water. The applicant also stated that total
body water and volume of distribution of urea can be expressed as a
volume or as a percentage of total weight and can vary based on
numerous factors including disease state. The applicant stated that it
is possible to estimate the percent of water for the ESRD population
from the HEMO trial as summarized in Leypoldt et al.\45\ The applicant
stated that in the trial, the mean patient weight was 69.8kg and the
mean patient volume of body water (V) was 30.9L. The applicant further
explained that from this, total body water (and volume of distribution
of urea) were calculated as 44.3 percent of the mean weight of patients
with ESRD (44.3 = 30.9L/69.8kg x 100). Per the applicant, applying this
44.3 percent of total body weight to the volumes of distribution in
Leypoldt et al.\46\ allowed for the conversion of the kinetic model
described into anticipated patient weights. The applicant further
stated that in calculating with standard blood flow and a higher
dialyzer mass transfer area coefficient for urea (KoA) dialyzer, a 200
minute treatment at a dialysate flow rate (Qd) of 300ml/min would not
achieve what the applicant refers to as the CMS target spKt/V target
1.2 for patients with a volume of distribution of urea (V) of 35L or
greater. The applicant stated that these assumptions were drawn from
NxStage[supreg] technical specifications.47 48 The applicant
stated that at 44.3 percent of total weight, this volume of
distribution of urea correlated to patients with ESRD with a mean
weight above 79 kg (79 = 35L/.443) or approximately 174 pounds. Per the
applicant, patients at or above this weight cannot be expected to
achieve a spKt/V urea of 1.2 on a thrice-weekly schedule using the
NxStage[supreg] system at its maximal dialysate flow rate.
---------------------------------------------------------------------------

\44\ Leypoldt, J.K., Prichard, S., Chertow, G.M., & Alvarez, L.
(2019). Differential molecular modeling predictions of mid and
conventional dialysate flows. Blood purification, 47(4), 369-376.
\45\ Ibid.
\46\ Ibid.
\47\ Leypoldt, J.K., Prichard, S., Chertow, G.M., & Alvarez, L.
(2019). Differential molecular modeling predictions of mid and
conventional dialysate flows. Blood purification, 47(4), 369-376.
\48\ Daugirdas JT, Greene T, Depner TA, Chumela C, Rocco, MJ,
Chertow, GM for the Hemodialysis (HEMO) Study Group.
Anthropometrically Estimated Total Body Water Volumes are Larger
than Modeled Urea Volume in Chronic Hemodialysis Patients: Effects
of Age, Race and Gender. 2003. Kidney Int. 64:1108-1119.
---------------------------------------------------------------------------

The applicant stated that for the majority of the U.S. prevalent
ESRD population between the ages of 22-74, whose mean weight is between
84.3-89.1 kg by age group,\49\ thrice-weekly therapy at home on
NxStage[supreg] would not achieve the Medicare coverage standard.
Specifically, per the applicant, Medicare's national coverage policy is
to reimburse for dialysis care 3 times per week, regardless of the
modality that is used, and health care providers are expected to ensure
that patients receive adequate clearance with the 3 times per week
cadence. The applicant also stated that MACs have discretion in
reimbursing additional treatments with medical justification.\50\ Per
the applicant, an analysis of Medicare

[[Page 61896]]

claims data from 2018 found that despite the limitations of the
reimbursement policy, Medicare paid for 5 or more treatments per week
in 50 percent of home HD patients nationwide, amounting to an estimated
annual cost to Medicare of $122 to $126 million.\51\ However, as we
stated in the CY 2022 ESRD PPS proposed rule (86 FR 36339), based on
CMS review of dialysis facility claims data, among all beneficiaries
who had home dialysis treatments in 2018, 39.1 percent had 5 or more
dialysis sessions at least once during any week. The overall percentage
of beneficiary-weeks that had 5 or more home HD sessions in 2018 was
20.9 percent. Medicare payment for these additional sessions totaled
$17 million. We noted that, as indicated in Local Coverage
Determination ID L35014, ``Frequency of Dialysis'' (revised effective
September 26, 2019),\52\ CMS established payment for HD based on
conventional treatment which is defined as 3 times per week. Sessions
in excess of 3 times per week must be both reasonable and necessary in
order to receive payment. Covered indications include metabolic
conditions (acidosis, hyperkalemia, hyperphosphatemia), fluid positive
status not controlled with routine dialysis, pregnancy, heart failure,
pericarditis, and incomplete dialysis secondary to hypotension or
access issues. The applicant asserted that the use of the Tablo[supreg]
System would decrease the number of necessary dialysis treatments,
without affecting patient outcomes such as clearance or
hospitalizations.
---------------------------------------------------------------------------

\49\ United States Renal Data System. 2020 USRDS Annual Data
Report: Epidemiology of kidney disease in the United States, End-
Stage Renal Disease Chapter 2. National Institutes of Health,
National Institute of Diabetes and Digestive and Kidney Diseases,
Bethesda, MD, 2020. Available at: <a href="https://adr.usrds.org/2020/end-stage-renaldisease/introduction-to-volume-2">https://adr.usrds.org/2020/end-stage-renaldisease/introduction-to-volume-2</a>. Accessed on Jan 21,
2021.
\50\ Wilk, A.S., Hirth, R.A., Zhang, W., Wheeler, J.R., Turenne,
M.N., Nahra, T. A., . . . & Messana, J.M. (2018). Persistent
variation in Medicare payment authorization for home hemodialysis
treatments. Health services research, 53(2), 649-670.
\51\ Health Management Associates (HMA) analysis of 2018 100
percent Medicare Outpatient file.
\52\ Medicare Coverage Database. Retrieved May 24, 2021 from:
<a href="https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35014&ver=39&NCDId=79&ncdver=1&SearchType=Advanced&CoverageSelection=Both&NCSelection=NCA%7CCAL%7CNCD%7CMEDCAC%7CTA%7CMCD&ArticleType=Ed%7CKey%7CSAD%7CFAQ&PolicyType=Final&s=-%7C5%7C6%7C66%7C67%7C9%7C38%7C63%7C41%7C64%7C65%7C44&KeyWord=transplant&KeyWordLookUp=Doc&KeyWordSearchType=Exact&kq=true&bc=IAAAADgAAAAA&">https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35014&ver=39&NCDId=79&ncdver=1&SearchType=Advanced&CoverageSelection=Both&NCSelection=NCA%7CCAL%7CNCD%7CMEDCAC%7CTA%7CMCD&ArticleType=Ed%7CKey%7CSAD%7CFAQ&PolicyType=Final&s=-%7C5%7C6%7C66%7C67%7C9%7C38%7C63%7C41%7C64%7C65%7C44&KeyWord=transplant&KeyWordLookUp=Doc&KeyWordSearchType=Exact&kq=true&bc=IAAAADgAAAAA&</a>
.
---------------------------------------------------------------------------

The applicant stated that there was clinical evidence and expert
consensus that as treatment frequency increases, native residual kidney
function drops, patient and care partner burden increases, and vascular
access complications increase.53 54 Per the applicant, home
use of the Tablo[supreg] System could reduce the need for a fifth or
sixth weekly treatment without increasing patients' symptom burden.\55\
The applicant stated that by achieving adequacy targets with fewer
treatments, Tablo[supreg] System patients could be expected to have
fewer vascular access interventions and health care providers will have
increased flexibility in personalizing the frequency and duration of
patient treatments.56 57 The applicant stated that reducing
treatment frequency while maintaining adequate patient clearance levels
may also reduce complications that lead to hospitalizations. The
applicant stated that during the Tablo[supreg] System IDE study,
patients using the Tablo[supreg] System 4 times per week, for an
average duration of less than 4 hours per treatment, had an all-cause
hospital admission rate of 426 per 1,000 patient-years whereas in the
general dialysis population, the all-cause admission rate was 1,688 per
1,000 patient-years, and for patients who utilized PD, the
hospitalization rate was 1,460 per 1,000 patient years.\58\
---------------------------------------------------------------------------

\53\ National Kidney Foundation. KDOQI clinical practice
guideline for hemodialysis adequacy: 2015 update. Am J Kidney Dis.
2015; 66(5):884-930.
\54\ Shafi T, Wilson RF, Greer R, Zhang A, Sozio S, Tan M, Bass
EB. End-stage Renal Disease in the Medicare Population: Frequency
and Duration of Hemodialysis and Quality of Life Assessment.
Technology Assessment Program Project ID No. JHE51000. (Prepared by
the Johns Hopkins University Evidence-based Practice Center under
contract number HHSA 290-2015-00006I) Rockville, MD: Agency for
Healthcare Research and Quality. July 2020. Available at: <a href="http://www.ahrq.gov/research/findings/ta/index.html">http://www.ahrq.gov/research/findings/ta/index.html</a>.
\55\ Safety and efficacy of the Tablo hemodialysis system for
in-center and home hemodialysis Plumb, T.J., Alvarez, L., Ross,
D.L., Lee, J.J., Mulhern, J.G., Bell, J.L., Abra, G., Prichard,
S.S., Chertow, G.M. and Aragon, M.A. (2019), Hemodialysis
International.
\56\ FHN Trial Group. (2010). In-center hemodialysis six times
per week versus three times per week. New England Journal of
Medicine, 363(24), 2287-2300.
\57\ Kuo, T.H., Tseng, C.T., Lin, W.H., Chao, J.Y., Wang, W.M.,
Li, C.Y., & Wang, M.C. (2015). Association Between Vascular Access
Dysfunction and Subsequent Major Adverse Cardiovascular Events in
Patients on Hemodialysis: A Population-Based Nested Case-Control
Study. Medicine, 94(26).
\58\ United States Renal Data System. 2020 USRDS Annual Data
Report: Epidemiology of kidney disease in the United States, End-
Stage Renal Disease Chapter 2. National Institutes of Health,
National Institute of Diabetes and Digestive and Kidney Diseases,
Bethesda, MD, 2020. Available at: <a href="https://adr.usrds.org/2020/end-stage-renaldisease/introduction-to-volume-2">https://adr.usrds.org/2020/end-stage-renaldisease/introduction-to-volume-2</a>. Reference Table G2.
---------------------------------------------------------------------------

The applicant stated that while NxStage[supreg] has not
specifically reported the hospitalization rates per patient-year from
its IDE study, published data from Weinhandl et al.,\59\ and Suri et
al.,\60\ reported hospital admission rates amongst patients on daily
home HD ranging from 930 to 1,663 per 1,000 patient-years, using a
national sample of dialysis patients matched for comparison to similar
peritoneal and in-center dialysis patients. We clarified in the CY 2022
ESRD PPS proposed rule (86 FR 36339-36340) that this would represent
930 to 1,663 cases observed among 1,000 persons during 1 year. The
applicant also noted that all data on home patients in Weinhandl et al.
came from a matched cohort of NxStage[supreg] patients. Per the
applicant, in Suri et al., data were collected prior to 2015 and that
during this timeframe, it could be reasonably assumed that home HD
patients were using NxStage[supreg] for treatment. The applicant stated
that the results from these studies suggested that patients receiving
treatment at home with NxStage[supreg] 5 to 6 times per week do not
have a lower all-cause hospitalization rate, relative to matched in-
center HD patients. The applicant concluded by stating that because of
the clinical and demographic diversity of the Tablo[supreg] System's
patient population, the applicant's results showed incremental
improvement over the hospitalization rate of the current home HD
population.
---------------------------------------------------------------------------

\59\ Weinhandl, E.D., Gilbertson, D.T., & Collins, A.J. (2016).
Mortality, hospitalization, and technique failure in daily home
hemodialysis and matched peritoneal dialysis patients: a matched
cohort study. American Journal of Kidney Diseases, 67(1), 98-110.
\60\ Suri, R.S., Li, L., & Nesrallah, G.E. (2015). The risk of
hospitalization and modality failure with home dialysis. Kidney
international, 88(2), 360-368.
---------------------------------------------------------------------------

Regarding the applicant's second claim that the Tablo[supreg]
System increased adherence to dialysis treatment and retention to home
therapy, the applicant stated that patients using the Tablo[supreg]
System have improved adherence to prescribed treatments and a higher
rate of retention to home therapy. The applicant further stated that
this increased adherence and retention is likely to improve patient
outcomes by reducing the rate of dialysis-related hospitalizations and
other adverse events associated with missing treatment in this patient
population.\61\
---------------------------------------------------------------------------

\61\ Chan, K.E., Thadhani, R.I., & Maddux, F.W. (2014).
Adherence barriers to chronic dialysis in the United States. Journal
of the American Society of Nephrology, 25(11), 2642-2648. Supporting
evidence of association between decreased dialysis adherence and
poor patient health and utilization outcomes.
---------------------------------------------------------------------------

The applicant stated that adherence to prescribed dialysis
treatments is crucial for dialysis patients because missed treatments
increased the risk of dialysis dropout, hospitalization, and death.\62\
Per the applicant, the Tablo[supreg] System IDE study demonstrated a 99
percent treatment adherence rate to all

[[Page 61897]]

prescribed home treatments \63\ among both prior in-center participants
and prior self-care home HD participants who used NxStage[supreg]. The
applicant also stated that the Tablo[supreg] System's adherence rates
were similar among both the prior in-center and prior self-care
participants. The applicant stated that these results represent a
significant improvement over the treatment adherence rate reported in
the NxStage[supreg] IDE, where the treatment compliance rate was
defined less stringently as missing 5 or fewer treatments of the 48
possible treatments and was only 89 percent among patients at home and
during the study period.\64\ Per the applicant, using a comparable
metric of missing 5 or fewer of all possible treatments at home,
Tablo[supreg] System IDE patients at home had a 100 percent treatment
compliance rate.
---------------------------------------------------------------------------

\62\ Weinhandl, Eric D., Collins Allan, Incidence of Therapy
Cessation among Home Hemodialysis Patients in the United States,
Abstract presented, American Society of Nephrology Kidney Week 2016.
\63\ Safety and efficacy of the Tablo hemodialysis system for
in-center and home hemodialysis Plumb, T.J., Alvarez, L., Ross,
D.L., Lee, J.J., Mulhern, J.G., Bell, J.L., Abra, G., Prichard,
S.S., Chertow, G.M. and Aragon, M.A. (2019), Hemodialysis
International.
\64\ Kraus, M., et al. A comparison of center-based vs. home-
based daily hemodialysis for patients with end-stage renal disease.
Hemodialysis International, 11: 468-477, (2007). The authors
performed a feasibility study to demonstrate the safety of center-
based vs. home-based daily hemodialysis with the NxStage System One
portable hemodialysis device.
---------------------------------------------------------------------------

The applicant stated that technique failure in home HD, defined as
reduced retention at home and a return to in-center care, has been high
with NxStage[supreg]. Per the applicant, real world data show that
technique failure occurs in 36 percent of home HD patients using
NxStage[supreg] within 1 year of initiating treatment.\65\ The
applicant stated that this was challenging for the patient and taxing
on the healthcare system that had invested in providing patients with
home dialysis training and in paying for more frequent therapy.
---------------------------------------------------------------------------

\65\ Weinhandl, Eric D., Collins Allan, Incidence of Therapy
Cessation among Home Hemodialysis Patients in the United States,
Abstract presented, American Society of Nephrology Kidney Week 2016.
---------------------------------------------------------------------------

The applicant stated that by directly comparing the Tablo[supreg]
System's retention to that of NxStage[supreg], the applicant assessed
rates in the analogous IDE populations while excluding those who exited
either study for reasons unrelated to the device such as receipt of a
transplant or death. The applicant stated that the Tablo[supreg] System
demonstrated a 97 percent (28 of 29) patient retention rate for the
entire IDE study and a 100 percent retention rate in the in-home phase
of the trial among both prior NxStage[supreg] users and prior in-center
patients.\66\ The applicant stated that in comparison, 81 percent of
participants completed the NxStage[supreg] IDE study.\67\
---------------------------------------------------------------------------

\66\ Safety and efficacy of the Tablo hemodialysis system for
in-center and home hemodialysis Plumb, T.J., Alvarez, L., Ross,
D.L., Lee, J.J., Mulhern, J.G., Bell, J.L., Abra, G., Prichard,
S.S., Chertow, G.M. and Aragon, M.A. (2019), Hemodialysis
International.
\67\ Kraus M, Burkart J, Hegeman R, Solomon R, Coplon N, Moran
J. A comparison of center-based vs. home-based daily hemodialysis
for patients with end-stage renal disease. Hemodial Int. 2007 Oct;
11(4):468-77. doi: 10.1111/j.1542-4758.2007.00229.x. PMID: 17922746.
---------------------------------------------------------------------------

The applicant stated that the Tablo[supreg] System's ease of use
contributed to the improved adherence and retention rates and that the
Tablo[supreg] System is designed to enable patients to become
proficient and independent in using the Tablo[supreg] System after an
average of 3.9 days.\68\ Per the applicant, published NxStage[supreg]
IDE data \69\ reported an average of 14.5 days ``to complete device
training on NxStage[supreg].'' The applicant stated that, in
comparison, device-related training time is reduced by at least 50
percent on the Tablo[supreg] System. Per the applicant, the reduced
training time and ease of use would likely improve retention and
potentially reduce the number of reimbursable training sessions. The
applicant stated that because of the significant role that caregivers
play in supporting home dialysis treatments,\70\ care partner burnout
and a patient's perception of being a burden is associated with
discontinuation of home therapy.71 72
---------------------------------------------------------------------------

\68\ Plumb, Troy J., Luis Alvarez, Dennis L. Ross, Joseph J.
Lee, Jeffrey G. Mulhern, Jeffrey L. Bell, Graham E. Abra, Sarah S.
Prichard, Glenn M. Chertow, and Michael A. Aragon. ``Self-care
training using the Tablo hemodialysis system.'' Hemodialysis
International (2020).
\69\ Kraus, M., et al, A comparison of center-based vs. home-
based daily hemodialysis for patients with end-stage renal disease.
Hemodialysis International, 11: 468-477, (2007).
\70\ Seshasai, R.K., et al. (2019) The home hemodialysis patient
experience: A qualitative assessment of modality use and
discontinuation. Hemodialysis International, 23: 139-150 (2019).
\71\ Suri, R.S., Larive, B., Hall, Y., Kimmel, P.L., Kliger,
A.S., Levin, N., . . . & Frequent Hemodialysis Network (FHN) Trial
Group. (2014). Effects of frequent hemodialysis on perceived
caregiver burden in the Frequent Hemodialysis Network trials.
Clinical Journal of the American Society of Nephrology, 9(5), 936-
942.
\72\ Jacquet, S., & Trinh, E. (2019). The potential burden of
home dialysis on patients and caregivers: a narrative review.
Canadian journal of kidney health and disease, 6, 2054358119893335.
---------------------------------------------------------------------------

Per the applicant, the 28 patients who entered the home phase of
the Tablo[supreg] System IDE study were asked weekly if they needed
help with their dialysis treatments during the prior 7 days. The
applicant stated that a 96 percent response rate (216 of 224 possible)
was achieved at the end of the study and that for both prior-in-center
and NxStage[supreg] study participants, in 79 percent of the treatment
weeks, patients reported needing no assistance from their care partner
in performing dialysis set-up, treatment, or breakdown. The applicant
explained that among the 13 prior in-home patients, all of whom were
formerly NxStage[supreg] users, participants reported needing help from
a trained individual with dialysis treatment in 69 percent of treatment
weeks, with 46 percent of instances involving a need for device-related
help. We clarified in the CY 2022 ESRD PPS proposed rule (86 FR 36340--
36341) that per Plumb, et al.,\73\ this was the baseline percentage and
reflected 9 of the 13 patients with previous self-care experience. The
applicant stated that patients reported needing help with treatment in
only 42 percent of treatment weeks while using the Tablo[supreg]
System, which was a 39 percent reduction from baseline NxStage[supreg]
use; and only 18 percent of these instances related to use of the
Tablo[supreg] System, which was a 61 percent reduction in rate from
baseline NxStage[supreg] use.\74\
---------------------------------------------------------------------------

\73\ Plumb, Troy J., Luis Alvarez, Dennis L. Ross, Joseph J.
Lee, Jeffrey G. Mulhern, Jeffrey L. Bell, Graham E. Abra, Sarah S.
Prichard, Glenn M. Chertow, and Michael A. Aragon. ``Self-care
training using the Tablo hemodialysis system.'' Hemodialysis
International (2020).
\74\ Ibid.
---------------------------------------------------------------------------

The applicant stated that it collected weekly data from patients by
asking them to rate the extent to which they believed that they were a
burden on a scale of 1 to 5, with 1 representing never and 5
representing always. The applicant stated that this measure was adapted
from an instrument used in assessing terminally ill patients.\75\ The
applicant stated that the subpopulation of study participants who had
previously used NxStage[supreg] reported an average score of 3.1 for
self-perceived burden on their care partner when using their prior
device, which subsequently reduced to 2.4 when using the Tablo[supreg]
System (a 23 percent reduction in score from baseline NxStage[supreg]
use).\76\ Per the applicant, these data underscored that a significant
increase in patients' confidence, ability to achieve treatment
independence at home, and subsequent reduction in the sense of self
burden can positively contributed to success in the home setting. The
applicant further noted that the ease of use, reduced training time,
and substantial reduction in care partner assistance required for

[[Page 61898]]

the Tablo[supreg] System correlated to the improved retention and
adherence rates in the Tablo[supreg] System IDE study. The applicant
stated that on a population level, this likely translated to reduced
barriers to continuing home HD once initiated, and ultimately, a
reduced risk of adverse outcomes due to missed treatments. The
applicant also stated that the Tablo[supreg] System's electronic data
capture and automatic wireless transmission eliminates the need for
manual record keeping, which represented an improvement with respect to
burden and monitoring as compared to NxStage[supreg].
---------------------------------------------------------------------------

\75\ Chochinov, H.M., Kristjanson, L.J., Hack, T.F., Hassard,
T., McClement, S., & Harlos, M. (2007). Burden to others and the
terminally ill. Journal of pain and symptom management, 34(5), 463-
471.
\76\ Chertow, G.M., Alvarez, L., Plumb, T.J., Prichard, S.S., &
Aragon, M. (2020). Patient-reported outcomes from the
investigational device exemption study of the Tablo hemodialysis
system. Hemodialysis International, 24(4), 480-486.
---------------------------------------------------------------------------

Regarding the applicant's third claim that the Tablo[supreg] System
improved patient quality of life, the applicant stated that patients on
the Tablo[supreg] System experienced reduced disease burden, dialysis
related symptoms, and an improved quality of life at home as compared
to in-center and existing home care options. Per the applicant,
patients with ESRD experience significant dialysis-related symptoms
including difficulty sleeping, dizziness, and pain associated with
recovery time that affect mental and physical health and lead to
decreased overall quality of life.\77\ Per the applicant, the
Tablo[supreg] System IDE study assessed several validated Patient-
Reported Outcome Measures (PROMs) to better understand overall health-
related quality of life (HR-QoL). The applicant explained that the
overall measure was the EQ-5D-5L, a validated, preference-based PROM in
which patients self-assess mobility, self-care, usual activities, pain/
discomfort, and anxiety/depression.\78\ The applicant stated that from
these domains, an index value is calculated to report a summary score
that ranges from 0 (death) to 1 (full health).
---------------------------------------------------------------------------

\77\ Gabbay, E., Meyer, K.B., Griffith, J.L., Richardson, M.M.,
& Miskulin, D.C. (2010). Temporal trends in healthrelated quality of
life among hemodialysis patients in the United States. Clinical
journal of the American Society of Nephrology, 5(2), 261-267.
\78\ Yang, F., Wong, C.K., Luo, N., Piercy, J., Moon, R., &
Jackson, J. (2019). Mapping the kidney disease quality of life 36-
item short form survey (KDQOL-36) to the EQ-5D-3L and the EQ-5D-5L
in patients undergoing dialysis. The European Journal of Health
Economics, 20(8), 1195-1206.
---------------------------------------------------------------------------

Per the applicant, while the NxStage[supreg] IDE study did not
report results for a quality-of-life instrument, HR-QoL was assessed in
NxStage[supreg] patients in a prospective multicenter observational
study referred to as the FREEDOM trial, which examined the effects of
at-home dialysis 6 times per week with the NxStage[supreg] System on
costs and HR-QoL using the SF-36 instrument. The applicant further
stated that the reported results at 4-month follow-up among these
patients \79\ translates to a mean EQ-5D score of 0.70. The applicant
included an appendix describing the Methodology to Derive EQ-5D Scores
from the FREEDOM Study Results in its application and derived a
predicted mean EQ-5D score of 0.695-0.70 at follow up for the FREEDOM
study. The applicant further noted that because this estimate is based
on the average aggregate change for an adjusted measure that was then
translated to the EQ-5D scale, and the applicant did not have access to
standard error estimates for the Mental Component Score (MCS) and
Physical Component Score (PCS), its interpretation of this estimate and
its variance is limited. Per the applicant, nonetheless, it provided a
sense of the comparable HR-QoL of this sample of NxStage[supreg]
patients at follow-up. The applicant further noted that mean EQ-5D
index values for traditional HD and PD patients reported from a meta-
analysis of existing studies in the literature are 0.56 (95 percent CI:
0.49-0.62) and 0.58 (95 percent CI: 0.5-0.67), respectively.\80\
---------------------------------------------------------------------------

\79\ Finkelstein, F.O., et al. (2012). At-home short daily
hemodialysis improves the long-term health-related quality of life.
Kidney international, 82(5), 561-569.
\80\ Liem, Y.S., Bosch, J.L., & Hunink, M.M. (2008). Preference-
based quality of life of patients on renal replacement therapy: a
systematic review and meta-analysis. Value in Health, 11(4), 733-
741.
---------------------------------------------------------------------------

Per the applicant, patients in the Tablo[supreg] System IDE study
reported mean EQ-5D index values of 0.821 (SD: <plus-minus>0.163) \81\
in the home phase of the study with final measures taken at
approximately 5 months from trial start. The applicant stated that this
is a significant improvement when using traditional HD patients as a
comparator, and higher overall HR-QoL as compared to NxStage[supreg]
patients. The applicant emphasized that participants in the
Tablo[supreg] System IDE trial underwent a reduced treatment frequency
as compared to participants in the FREEDOM study who were prescribed 6
treatments per week on NxStage[supreg]. The applicant stated that among
patients in the Tablo[supreg] System IDE study who had previously been
using NxStage[supreg], the mean EQ-5D score during the in-home phase of
the study was 0.906 (SD: <plus-minus>0.119) and asserted that this is
significantly greater than index population values for HD and PD.
---------------------------------------------------------------------------

\81\ Chertow, G.M., Alvarez, L., Plumb, T.J., Prichard, S.S., &
Aragon, M. (2020). Patient-reported outcomes from the
investigational device exemption study of the Tablo hemodialysis
system. Hemodialysis International, 24(4), 480-486.
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The applicant stated that sleep problems are present in 60 percent
of patients with chronic kidney disease (CKD) and ESRD \82\ and that
patients ranked fatigue and lack of energy as the most important
contributor to their decreased quality of life.\83\ Per the applicant,
the frequency of sleep-related symptoms among the Tablo[supreg]
System's patients was assessed by a survey that was administered weekly
during the Tablo[supreg] System IDE study. The applicant stated that,
in the absence of a well-validated sleep survey specific to the ESRD
population, study investigators selected survey questions from
previously validated sleep questionnaires in the non-ESRD population,
based on their relevance to the study population.84 85 The
applicant explained that questions were designed to focus on quality of
sleep and restfulness and noted that these measures are validated for
use among chronically ill populations and measure the frequency of 4
key sleep-related symptoms. The applicant stated that, while at home,
patients on the Tablo[supreg] System reported improved quality of
sleep, with a measurable reduction in rate of patient-reported sleep
symptoms ranging from a 10-60 percent reduction, depending on
symptom.\86\ The applicant stated that this reduction was observed
among study participants who were previously receiving dialysis in-
center (average magnitude of reduction in rate across symptoms: 42
percent) and among study participants who were previously receiving in-
home dialysis on NxStage[supreg] (average magnitude of reduction in
rate across symptoms: 27 percent). Per the applicant, on average,
sleep-related difficulties reduced from being reported in 33 percent of
treatment weeks while on NxStage[supreg] to 23 percent of treatment
weeks while on the Tablo[supreg] System.
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\82\ Davison SN, Levin A, Moss AH, Jha V, Brown EA, Brennan F,
Murtagh FE, Naicker S, Germain MJ, O'Donoghue DJ, Morton RL, Obrador
GT; Kidney Disease: Improving Global Outcomes. Executive summary of
the KDIGO Controversies Conference on Supportive Care in Chronic
Kidney Disease: developing a roadmap to improving quality care.
Kidney Int. 2015 Sep;88(3):447-59.
\83\ Urquhart-Secord, Rachel et al (2016). Patient and Caregiver
Priorities for Outcomes in Hemodialysis: An International Nominal
Group Technique Study American Journal of Kidney Diseases, Volume
68, Issue 3, 444-454.
\84\ Morin, C.M., Belleville, G., B[eacute]langer, L., & Ivers,
H. (2011). The Insomnia Severity Index: psychometric indicators to
detect insomnia cases

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