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Proposed Rule2021-14250

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

July 9, 2021

Issuing agencies

Health and Human Services DepartmentCenters for Medicare & Medicaid Services

Abstract

This proposed rule would update the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2022. This rulemaking also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, this rulemaking proposes to update requirements for the ESRD Quality Incentive Program (QIP), including a proposed measure suppression policy for the duration of the coronavirus disease 2019 (COVID-19) public health emergency (PHE) and as well as proposals to suppress individual ESRD QIP measures under that proposed measure suppression policy. This proposed rule also announces an extension of time for facilities to report September through December 2020 ESRD QIP data under our Extraordinary Circumstances Exception (ECE) policy due to CMS operational issues, and proposes to not score facilities or reduce payment to any facility in PY 2022. In addition, this proposed rule includes requests for information on topics that are relevant to the ESRD QIP. Further, this rule also proposes 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. Finally, this proposed rule includes several requests for information to inform payment reform under the ESRD PPS.

Full Text

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[Federal Register Volume 86, Number 129 (Friday, July 9, 2021)]
[Proposed Rules]
[Pages 36322-36437]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14250]

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Vol. 86

Friday,

No. 129

July 9, 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 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; Proposed Rule

Federal Register / Vol. 86 , No. 129 / Friday, July 9, 2021 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 413 and 512

[CMS-1749-P]
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: Proposed rule.

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SUMMARY: This proposed rule would update the End-Stage Renal Disease
(ESRD) Prospective Payment System (PPS) for calendar year (CY) 2022.
This rulemaking also proposes to update the payment rate for renal
dialysis services furnished by an ESRD facility to individuals with
acute kidney injury (AKI). In addition, this rulemaking proposes to
update requirements for the ESRD Quality Incentive Program (QIP),
including a proposed measure suppression policy for the duration of the
coronavirus disease 2019 (COVID-19) public health emergency (PHE) and
as well as proposals to suppress individual ESRD QIP measures under
that proposed measure suppression policy. This proposed rule also
announces an extension of time for facilities to report September
through December 2020 ESRD QIP data under our Extraordinary
Circumstances Exception (ECE) policy due to CMS operational issues, and
proposes to not score facilities or reduce payment to any facility in
PY 2022. In addition, this proposed rule includes requests for
information on topics that are relevant to the ESRD QIP. Further, this
rule also proposes 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. Finally, this proposed rule
includes several requests for information to inform payment reform
under the ESRD PPS.

DATES: To be assured consideration, comments must be submitted at one
of the addresses provided below, by August 31, 2021.

ADDRESSES: In commenting, please refer to file code CMS-1749-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission. Comments, including mass comment
submissions, must be submitted in one of the following three ways
(please choose only one of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1749-P, P.O. Box 8010,
Baltimore, MD 21244-8010.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1749-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:
<a href="/cdn-cgi/l/email-protection#c78294958397a6beaaa2a9b387a4aab4e9afafb4e9a0a8b1">[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#0e4b5d5c4a4f7e7e62676d6f7a6761607d4e6d637d2066667d20696178">[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#6d28392e402e2020242d0e001e4305051e430a021b">[email&#160;protected]</a>, for issues related to the ESRD Treatment
Choices (ETC) Model.

SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the search instructions on that website to
view public comments. CMS will not post on <a href="http://Regulations.gov">Regulations.gov</a> public
comments that make threats to individuals or institutions or suggest
that the individual will take actions to harm the individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.
Current Procedural Terminology (CPT) Copyright Notice: Throughout
this proposed 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
C. Proposed 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. Proposed 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 and Notification of ECE Due to ESRD Quality
Reporting System Issues
C. Proposed Flexibilities for the ESRD QIP in Response to the
COVID-19 PHE
D. Proposed Special Scoring Methodology and Payment Policy for
the PY 2022 ESRD QIP
E. Proposed 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. Provisions of the Proposed Rule
C. Requests for Information (RFIs) on Topics Relevant to ETC
Model
VI. Requests for Information
A. Informing Payment Reform Under the ESRD PPS

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B. Technical Expert Panels (TEPs)
C. Calculation of the Low-Volume Payment Adjustment (LVPA)
D. Calculation of the Case-Mix Adjustments
E. Calculation of the Outlier Payment Adjustment
F. Calculation of the Pediatric Dialysis Payment Adjustment
G. Modifying the ESRD PPS and Hospital Cost Reports
H. Modifying the Pediatric Cost Report
I. Modifying Site of Services Provided to Medicare Beneficiaries
with Acute Kidney Injury (AKI)
VII. Collection of Information Requirements
A. Legislative Requirement for Solicitation of Comments
B. Requirements in Regulation Text
C. Additional Information Collection Requirements
VIII. Response to Comments
IX. Economic Analyses
A. Regulatory Impact Analysis
B. Detailed Economic Analysis
C. Accounting Statement
D. Regulatory Flexibility Act Analysis (RFA)
E. Unfunded Mandates Reform Act Analysis (UMRA)
F. Federalism
G. Congressional Review Act
X. Files Available to the Public via the Internet
Regulations Text

I. Executive Summary

A. Purpose

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
proposes updates to the ESRD PPS for CY 2022.
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
proposes to update 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 proposes 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 announcing an extension of time for facilities to
report September-December 2020 ESRD QIP data under our Extraordinary
Circumstances Exception (ECE) policy due to CMS operational issues.
Beginning with the PY 2024 ESRD QIP, we are proposing to update the
specifications for the SHR clinical measure. We are also proposing for
the PY 2024 ESRD QIP to adopt CY 2019 as the baseline period for
purposes of calculating the achievement thresholds, benchmarks, and
performance standard values. Although no new requirements are proposed
for the PY 2025 ESRD QIP, this proposed rule includes policies that
would apply in PY 2025. This proposed rule also includes requests for
information on several important topics, including strategies that CMS
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 rulemaking proposes to implement 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-

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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 rulemaking proposes 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 proposing to add
processes and requirements for ETC Participants to receive certain data
from CMS and to include certain additional waivers and flexibilities as
part of the ETC Model test. This proposed rule also includes requests
for information regarding the placement of peritoneal dialysis
catheters and the development of a home dialysis beneficiary experience
measure.

B. Summary of the Major Provisions

1. ESRD PPS
<bullet> Update to the ESRD PPS base rate for CY 2022: The proposed
CY 2022 ESRD PPS base rate is $255.55. This proposed amount reflects
the application of the wage index budget-neutrality adjustment factor
(.999546) and a productivity-adjusted market basket increase of 1.0
percent as required by section 1881(b)(14)(F)(i)(I) of the Act,
equaling $255.55 (($253.13 x .999546) x 1.010 = $255.55).
<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 proposing to update 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 proposing to update
the outlier policy using the most current data, as well as update 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 proposed FDL amount
for pediatric beneficiaries would decrease from $44.78 to $30.38, and
the MAP amount would decrease from $30.88 to $28.73, as compared to CY
2021 values. For adult beneficiaries, the proposed FDL amount would
decrease from $122.49 to $111.18, and the MAP amount would decrease
from $50.92 to $47.87. 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 proposed 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 $9.41. This proposed offset amount
reflects the application of the productivity-adjusted market basket
increase of 1.0 percent ($9.32 x 1.010 = $9.41).
<bullet> TPNIES applications received for CY 2022: This proposed
rule presents 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.
2. Payment for Renal Dialysis Services Furnished to Individuals With
AKI
We are proposing to update the AKI payment rate for CY 2022 to
$255.55, which is the same as the base rate proposed under the ESRD PPS
for CY 2022.
3. ESRD QIP
We are announcing an extension of time for facilities to report
September through December 2020 ESRD QIP data under our Extraordinary
Circumstances Exception (ECE) policy due to CMS operational issues. We
are proposing to adopt a measure suppression policy for the duration of
the COVID-19 PHE that would enable 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 proposing 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 proposed measure suppression policy. Finally, we are
proposing to not score or reduce payment to any facility in PY 2022.
Beginning with the PY 2024 ESRD QIP, we are proposing to update the
specifications for the SHR clinical measure. We are also proposing for
the PY 2024 ESRD QIP to adopt CY 2019 as the baseline period for
purposes of calculating the achievement thresholds, benchmarks, and
performance standard values. This proposed rule also announces the
performance standards and payment reductions that would apply for PY
2024. This proposed rule describes several policies continuing for PY
2025, but does not propose any new requirements beginning with the PY
2025 ESRD QIP.
This proposed rule includes requests for public comment on several
important topics, including closing the gap in health equity, adding a
COVID-19 vaccination measure for health care personnel (HCP) and 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 the continued transformation of our quality measurement
enterprise toward greater digital capture of data and use of the Fast
Healthcare Interoperability Resources (FHIR[supreg]) standard.
4. ETC Model
We are proposing to implement 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 propose to
modify the methodology for attributing Pre-emptive LDT Beneficiaries to
Managing Clinicians, such that a Pre-emptive LDT Beneficiary would 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
propose adding nocturnal in-center dialysis to the calculation of the
home dialysis rate for ESRD facilities not owned in whole or in part by
a large dialysis organization (LDO) as well as Managing Clinicians.
<bullet> Transplant Rate Beneficiary Exclusion: To better align
with common reasons transplant centers do not place patients on the
transplant waitlist, we propose to exclude beneficiaries with a
diagnosis of, and who are receiving

[[Page 36325]]

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 propose
to increase achievement benchmarks by 10 percent over rates observed in
Comparison Geographic Areas every two MYs, beginning in MY3 (2022). We
also propose to 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 our proposal to stratify achievement
benchmarks based on the proportion of beneficiaries who are dual-
eligible or LIS recipients, we propose to introduce the Health Equity
Incentive to the improvement scoring methodology used in calculating
the PPA. CMS expects that the Health Equity Incentive would 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 propose to 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 proposing a process by which CMS would share
certain model data with ETC Participants.
<bullet> Medicare Waivers: We are proposing 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: 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.
<bullet> Kidney Disease Patient Education Services Coinsurance
Waivers: We are proposing to 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
anticipate making the determination that the anti-kickback statute safe
harbor for CMS-sponsored model patient incentives (42 CFR
1001.952(ii)), would be available to protect the reduction or
elimination of coinsurance performed in accordance with our proposed
policy, if finalized.

C. Summary of Costs and Benefits

In section IX.B of this proposed rule, we set forth a detailed
analysis of the impacts that the proposed changes would have on
affected entities and beneficiaries. The impacts include the following:
1. Impacts of the Proposed ESRD PPS
The impact table in section IX.B.1.a of this proposed 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 proposed CY
2022 changes is projected to be a 1.2 percent increase in payments.
Hospital-based ESRD facilities have an estimated 1.3 percent increase
in payments compared with freestanding facilities with an estimated 1.2
percent increase. We estimate that the aggregate ESRD PPS expenditures
would increase by approximately $140 million in CY 2022 compared to CY
2021. This reflects a $120 million increase from the payment rate
update and a $20 million increase due to the updates to the outlier
threshold amounts. Because of the projected 1.2 percent overall payment
increase, we estimate there would be an increase in beneficiary
coinsurance payments of 1.2 percent in CY 2022, which translates to
approximately $30 million.
2. Impacts of the Proposed Payment for Renal Dialysis Services
Furnished to Individuals With AKI
The impact table in section IX.B.2.a of this proposed 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 proposed CY
2022 changes is projected to be a 1.0 percent increase in payments for
individuals with AKI. Hospital-based ESRD facilities have an estimated
1.1 percent increase in payments compared with freestanding ESRD
facilities with an estimated 1.0 percent increase. The overall impact
reflects the effects of the updated wage index and the proposed payment
rate update. We estimate that the aggregate payments made to ESRD
facilities for renal dialysis services furnished to patients with AKI,
at the proposed CY 2022 ESRD PPS base rate, would increase by $1
million in CY 2022 compared to CY 2021.
3. Impacts of the Proposed ESRD QIP
Our proposals 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 necessitates 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 proposals
impacting the PY 2022 ESRD QIP we are making in this proposed rule, we
are modifying our previous estimate. We now estimate that the overall
economic impact of the PY 2022 ESRD QIP would be approximately $215
million. The $215 million figure for PY 2022 includes costs associated
with the collection of information requirements. If our proposals are
finalized as proposed, there would be no payment reductions in PY 2022.
We estimate that the overall economic impact of the PY 2024 ESRD QIP
would be approximately $232 million as a result of the policies we have
previously finalized and the proposals in this proposed rule. The $232
million figure for PY 2024 includes costs associated with the
collection of information requirements, which we estimate would be
approximately $215 million, and $17 million in estimated payment
reductions across all facilities. We also estimate that the overall
economic impact of the PY 2025 ESRD QIP would be approximately $232
million as a result of the policies we have previously finalized.
4. Impacts of Proposed Changes to the ETC Model
The impact estimate in section IX.B.4 of this proposed rule
describes the estimated change in anticipated Medicare program savings
arising from

[[Page 36326]]

the ETC Model over the duration of the ETC Model as a result of the
changes proposed in this proposed rule. We estimate that the ETC Model
would result in $38 million in net savings over the 6.5-year duration
of the ETC Model. We also estimate that $7 million of the estimated $38
million in net savings would be attributable to changes proposed in
this proposed 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
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 of 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 definitions 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

[[Page 36327]]

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

1. Proposed CY 2022 ESRD PPS Update
a. Proposed 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 propose 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 propose 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 is 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 note that
for CY 2022 and beyond, CMS is 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) is projected to be 0.6 percent.
As a result of these provisions, the proposed CY 2022 ESRD market
basket increase factor reduced by the productivity adjustment is 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 are proposing that if more recent
data become available after the publication of this 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.
For the CY 2022 ESRD payment update, we propose 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).
b. The Proposed 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 would 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

[[Page 36328]]

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 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).\1\
---------------------------------------------------------------------------

\1\ We note that for the CY 2020 ESRD PPS final rule, we did not
apply the statewide urban average to Carson City, Nevada because
hospital data was available to compute the wage index.
---------------------------------------------------------------------------

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.
For CY 2022, we are proposing to update the ESRD PPS wage index to
use the most recent hospital wage data. The proposed 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 proposed CY 2022 wage index. Addendum B provides an ESRD
facility level impact analysis. Addendum B 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>.
c. Proposed 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.\2\ <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>. 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.
---------------------------------------------------------------------------

\2\ 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.
---------------------------------------------------------------------------

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)

[[Page 36329]]

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 propose that the outlier services MAP amounts and
FDL amounts would be derived from claims data from CY 2020. Because we
believe that any adjustments made to the MAP amounts under the ESRD PPS
should be based upon the most recent data year available in order to
best predict any future outlier payments, we propose 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 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 the CY 2021 ESRD PPS final rule (85 FR 71438), CY 2019
claims data show outlier payments represented approximately 0.5 percent
of total payments. As discussed in section II.B.1.c.(1) of this
proposed 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 CY 2022, we propose to update the outlier services MAP amounts
and FDL amounts to reflect the utilization of outlier services reported
on 2020 claims. For this proposed rule, the outlier services MAP
amounts and FDL amounts were updated using 2020 claims data. 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 proposed estimates for this rule. The estimates for the
proposed CY 2022 outlier policy, which are included in Column II of
Table 1, were inflation adjusted to reflect projected 2022 prices for
outlier services.
[GRAPHIC] [TIFF OMITTED] TP09JY21.000

The estimated FDL amount per treatment that determines the CY 2022
outlier threshold amount for adults (Column II; $111.18) 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 $47.87. For

[[Page 36330]]

pediatric patients, there is a decrease in the FDL amount from $44.78
to $30.38. There is a corresponding decrease in the adjusted average
MAP for outlier services among pediatric patients, from $30.08 to
$28.73.
We estimate that the percentage of patient months qualifying for
outlier payments in CY 2022 would be 5.45 percent for adult patients
and 11.37 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 noted in past rulemaking,
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 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 note that recalibration of the FDL
amounts in this proposed rule 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.
d. Proposed 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 proposing an ESRD PPS base rate for CY 2022 of $255.55. 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 are not proposing 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
proposed 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 proposed rule,
the proposed 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 proposed wage index budget-neutrality adjustment
factor is .999546. This application would yield a CY 2022 ESRD PPS
proposed base rate of $253.02 prior to the application of the proposed
market basket increase ($253.13 x .999546 = $253.02).
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 proposed ESRDB
market basket percentage increase factor is 1.6 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, the proposed
productivity adjustment for CY 2021 is 0.6 percent, thus yielding a
proposed update to the base rate of 1.0 percent for CY 2022. Therefore,
the CY 2022 ESRD PPS proposed base rate is $255.55 ($253.02 x 1.010 =
$255.55).
In summary, we are proposing a CY 2022 ESRD PPS base rate of
$255.55. This amount reflects a proposed CY 2022 wage index budget-
neutrality adjustment factor of .999546, and the CY 2022 ESRD PPS
productivity-adjusted market basket update of 1.0 percent.
e. Update to the Offset Amount for TPNIES
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. We finalized the additional steps that the
Medicare Administrative Contractors (MACs) must follow to establish the
basis of payment of the TPNIES for these capital-related assets that
are home dialysis machines when used in the home, including an offset
to the pre-adjusted per treatment amount to account for the cost of the
home dialysis machine that is already in the ESRD PPS base rate. We
will pay 65 percent of the MAC-determined preadjusted per treatment
amount reduced by an offset for 2-calendar

[[Page 36331]]

years. Section Sec. 413.236(f)(3)(v) states that effective January 1,
2022, CMS will annually update the amount determined in paragraph
(f)(3)(iv) of Sec. 413.236 by the ESRD bundled market basket
percentage increase factor minus the productivity adjustment factor.
The CY 2021 offset amount for TPNIES 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 proposed rule, 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 CY 2021 offset amount results in
a proposed CY 2022 offset amount of $9.41($9.32 x 1.010). We will
update this calculation to use the most recent data available in the CY
2022 ESRD PPS final rule.

C. Proposed 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 SCI criteria specified in the Inpatient Prospective
Payment System (IPPS) regulations at 42 CFR 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 SCI for purposes of the TPNIES under
the ESRD PPS based on the IPPS SCI 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 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 SCI 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 discuss in the CY 2020 ESRD PPS final rule (84

[[Page 36332]]

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 SCI 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 SCI criterion, as the
guidance has 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 while in the CY 2020 ESRD PPS proposed rule (84 FR
38354), we stated 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 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. 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 provide a
description of the new home dialysis machine and pertinent facts in the
ESRD PPS proposed rule so the public may comment and then publish the
results in the ESRD PPS final rule. We will consider whether the new
home dialysis machine meets the eligibility criteria specified in the
proposed revisions to 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 will need to reapply within 3 years beginning on the date of
FDA marketing authorization in order to be considered for the TPNIES,
in accordance with the proposed revisions to 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 by
requiring 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, and 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

[[Page 36333]]

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. 412.87(b)(1) of this chapter; 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. A
discussion of these applications is presented below. The applications
received are for technologies commonly used for the treatment of ESRD:
Hemodialysis (HD) and peritoneal dialysis (PD). Detailed definitions
for HD and PD are found in Chapter 11, Section 10 of the Medicare
Benefits Policy Manual (Pub. L. 100-02).\3\ 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. PD is a process that involves waste products
passing from the patient's body through the peritoneal membrane into
the peritoneal (abdominal) cavity where the bath solution (dialysate)
is introduced and removed periodically.
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\3\ 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 (Tablo[supreg]) 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 also 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 simple-to-use
touchscreen interface; (2) a proprietary, disposable, single-use pre-
strung cartridge that easily clicks into place, minimizing steps, touch
points, and connections; 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 unique
features combine to provide a significantly differentiated HD solution
with many benefits. First, the applicant stated that the Tablo[supreg]
System's intuitive touchscreen interface makes it easy to learn and
use, guiding users through treatment from start to finish using step-
by-step 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 does 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 is 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 user-friendly pre-strung blood, saline,
and infusion tubing and a series of sensor-receptors mounted to a user-
friendly organizer snaps easily 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.\4\ 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.5 6 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.7 8
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\4\ 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.
\5\ 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.
\6\ 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.
\7\ 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.
\8\ 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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[[Page 36334]]

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.\9\ The applicant stated that the
Tablo[supreg] System was designed to address many system-related
barriers that result in patients resigning themselves to in-center care
and/or stopping home modalities due to the burden of self-managed
therapy.
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\9\ 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 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.\10\
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\10\ 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.\11\ 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
demonstrate 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.\12\ 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,\13\ as compared to 4:1 in Canada.\14\
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\11\ Ibid.
\12\ 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.
\13\ 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.
\14\ 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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The applicant asserted that that the Tablo[supreg] System presents
a significant clinical improvement over NxStage[supreg] System One
(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 necessary for the provision of maintenance
dialysis and, therefore, we would consider this 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
stated that the Tablo[supreg] System received FDA marketing
authorization for home use on March 31, 2020. Therefore, the
Tablo[supreg] System is considered new. We note that, in reviewing the
enclosure to which the March 31, 2020 FDA authorization letter refers,
the applicant's Section 510(k) submission indicates that the
Tablo[supreg] Cartridge was reviewed separately from the Tablo[supreg]
System and has its own separate 510(k) clearance. As discussed 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 is not new.
(3) Commercial Availability Criterion (Sec. 413.236(b)(3))
With respect to the third TPNIES eligibility criterion under Sec.
413.236(b)(3), whether the item is commercial available by January 1 of
the particular calendar year, meaning the year in which the payment
adjustment would take effect, the applicant stated that the
Tablo[supreg] System became available for home use on April 1, 2020.
Therefore, the Tablo[supreg] System is commercially available.
(4) HCPCS Level II Application Criterion (Sec. 413.236(b)(4))
With respect to the fourth TPNIES eligibility criterion under Sec.
413.236(b)(4), whether the applicant submitted a HCPCS Level II code
application by the July 6, 2021 deadline, the applicant stated that it
intends to submit a HCPCS Level II code application by the deadline.
(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 SCI
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 SCI claims: (1) Decreased treatment
frequency with adequate dialysis clearance; (2) increased adherence to
dialysis treatment and retention to home therapy; and (3) improved
patient

[[Page 36335]]

quality of life. The applicant supported these claims with the
Tablo[supreg] Investigational Device Exemption (IDE) Study \15\ and
secondary support from four papers 16 17 18 19 and two
posters.20 21 The applicant also provided comparison data
from three studies directly related to the incumbent
22 23 24 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.\25\
---------------------------------------------------------------------------

\15\ <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>.
\16\ 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.
\17\ 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.
\18\ 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.
\19\ 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).
\20\ 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.
\21\ 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.
\22\ 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).
\23\ 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.
\24\ 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.
\25\ 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 provide an overview of these ten sources below, followed by the
applicant's summary of how the data support each claim of SCI. We
conclude with a discussion of the way in which we have applied the
requirements of Sec. 413.236(b)(5) to our review of the application
and a summary of our concerns. We have not included 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.
(a) Applicant SCI Sources
As stated previously, the applicant's primary support for its three
SCI claims comes 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] 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] IDE study sample was comprised of a
representative cohort of dialysis patients and reports 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] Console
fluid removal algorithm, respectively.\26\ We clarify 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 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).
---------------------------------------------------------------------------

\26\ <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.\27\
---------------------------------------------------------------------------

\27\ 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] IDE study (discussed previously), including
health-related quality of life, to further assess the safety of home HD
with the Tablo[supreg]

[[Page 36336]]

System. Demographic information identified the mean age as 49.8 <plus-
minus> 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 <plus-minus> 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.\28\
---------------------------------------------------------------------------

\28\ 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 distribution range modeled by
the authors ranged from 25 to 45 L. Under ideal conditions, the authors
demonstrate 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.\29\
---------------------------------------------------------------------------

\29\ 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] IDE
study (discussed previously). Demographic information reflected the
mean age as 52.3 <plus-minus> 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.\30\
---------------------------------------------------------------------------

\30\ 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., reports additional data
from the Tablo[supreg] 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

[[Page 36337]]

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.\31\
---------------------------------------------------------------------------

\31\ 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] IDE study (previously discussed). The authors noted that
13 of the 30 participants in the Tablo[supreg] 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.\32\
---------------------------------------------------------------------------

\32\ 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 this section of the proposed rule, the
applicant submitted several sources pertaining to the incumbent,
NxStage.[supreg] First, an article from Kraus et al., describes 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
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.\33\
---------------------------------------------------------------------------

\33\ 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., reports 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.\34\
---------------------------------------------------------------------------

\34\ 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 <plus-
minus> 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 peritoneal dialysis, 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.\35\
---------------------------------------------------------------------------

\35\ 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.

---------------------------------------------------------------------------

[[Page 36338]]

Fourth, in Suri et al., 1116, daily home HD patients were matched
by propensity scores to 2784, contemporaneous USRDS patients receiving
home peritoneal dialysis. The authors compared hospitalization rates
from cardiovascular, infectious, access-related or bleeding causes, and
modality failure risk. Similar analyses were performed for 1187, daily
home HD patients matched to 3173, 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 peritoneal dialysis). 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.\36\
---------------------------------------------------------------------------

\36\ 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 SCI Claims
Regarding the applicant's first claim that the Tablo[supreg] System
decreases treatment frequency with adequate 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.\37\ 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,\38\ as
compared to NxStage[supreg] IDE patients prescribed therapy at 6 days
per week.\39\
---------------------------------------------------------------------------

\37\ 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.
\38\ 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.
\39\ 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
Pureflow 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.\40\ 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
\41\ at home for these patients to meet the desired clearance level.
---------------------------------------------------------------------------

\40\ 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.
\41\ 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.,\42\ allow 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.\43\ 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) are 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.\44\ allows the conversion of the kinetic model
described into anticipated patient weights. The applicant further
stated

[[Page 36339]]

that in calculating with standard blood flow and a higher dialyzer mass
transfer area coefficient for urea (KoA) diayzer, 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.45 46 The applicant
stated that at 44.3 percent of total weight, this volume of
distribution of urea correlates 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.
---------------------------------------------------------------------------

\42\ 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.
\43\ Ibid.
\44\ Ibid.
\45\ 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.
\46\ 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,\47\ 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 Medicare Administrative
Contractors (MACs) have discretion in reimbursing additional treatments
with medical justification.\48\ Per the applicant, an analysis of
Medicare claims data from 2018 finds that despite the limitations of
the reimbursement policy, Medicare is paying 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.\49\ However,
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 note that, as indicated in
Local Coverage Determination ID L35014, ``Frequency of Dialysis''
(revised effective September 26, 2019),\50\ 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.
---------------------------------------------------------------------------

\47\ 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.
\48\ 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.
\49\ Health Management Associates (HMA) analysis of 2018 100
percent Medicare Outpatient file.
\50\ 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 is 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.51 52 Per the applicant, home
use of the Tablo[supreg] System can reduce the need for a fifth or
sixth weekly treatment without increasing patients' symptom burden.\53\
The applicant stated that by achieving adequacy targets with fewer
treatments, Tablo[supreg] System patients can 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.54 55 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] 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 is 1,688 per 1,000
patient-years, and for patients who utilize peritoneal dialysis, the
hospitalization rate is 1,460 per 1,000 patient years.\56\
---------------------------------------------------------------------------

\51\ National Kidney Foundation. KDOQI clinical practice
guideline for hemodialysis adequacy: 2015 update. Am J Kidney Dis.
2015;66(5):884-930.
\52\ 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>.
\53\ 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.
\54\ 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.
\55\ 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).
\56\ 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.,\57\ and Suri et
al.,\58\ report 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 clarify that this would
represent 930 to 1,663 cases observed

[[Page 36340]]

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 can be
reasonably assumed that home HD patients were using NxStage[supreg] for
treatment. The applicant stated that the results from these studies
suggest 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 show incremental improvement over the
hospitalization rate of the current home HD population.
---------------------------------------------------------------------------

\57\ 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.
\58\ 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 increases 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.\59\
---------------------------------------------------------------------------

\59\ 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
increases the risk of dialysis dropout, hospitalization, and death.\60\
Per the applicant, the Tablo[supreg] IDE study demonstrated a 99
percent treatment adherence rate to all prescribed home treatments \61\
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.\62\ Per the
applicant, using a comparable metric of missing 5 or fewer of all
possible treatments at home, Tablo[supreg] IDE patients at home had a
100 percent treatment compliance rate.
---------------------------------------------------------------------------

\60\ 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.
\61\ 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.
\62\ 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.\63\ The
applicant stated that this is challenging for the patient and taxing on
the healthcare system that has invested in providing patients with home
dialysis training and in paying for more frequent therapy.
---------------------------------------------------------------------------

\63\ 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.\64\ The applicant stated that in comparison, 81 percent of
participants completed the NxStage[supreg] IDE study.\65\
---------------------------------------------------------------------------

\64\ 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.
\65\ 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.\66\ Per the applicant, published NxStage[supreg]
IDE data \67\ 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 will 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,\68\ care partner burnout
and a patient's perception of being a burden is associated with
discontinuation of home therapy.69 70 Per the applicant, the
28 patients who entered the home phase of the Tablo[supreg] 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
clarify that per Plumb, et al.,\71\ this

[[Page 36341]]

is the baseline percentage and reflects 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 is 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 is a
61 percent reduction in rate from baseline NxStage[supreg] use.\72\
---------------------------------------------------------------------------

\66\ 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).
\67\ 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).
\68\ 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).
\69\ 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.
\70\ 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.
\71\ 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).
\72\ 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.\73\ 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).\74\ Per the applicant, these data underscore 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 contribute 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 the
Tablo[supreg] System correlated to the improved retention and adherence
rates in the Tablo[supreg] IDE study. The applicant stated that on a
population level, this likely translates 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 represents an improvement with respect to burden and monitoring
as compared to NxStage[supreg].
---------------------------------------------------------------------------

\73\ 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.
\74\ 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
improves patient quality of life, the applicant stated that patients on
the Tablo[supreg] System experience 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.\75\ Per the applicant, the
Tablo[supreg] 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.\76\ 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).
---------------------------------------------------------------------------

\75\ 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.
\76\ 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 \77\ 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 provides 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.\78\
---------------------------------------------------------------------------

\77\ 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.
\78\ 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] IDE study reported
mean EQ-5D index values of 0.821 (SD: <plus-minus>0.163) \79\ 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] 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] 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
peritoneal dialysis.
---------------------------------------------------------------------------

\79\ 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.
---------------------------------------------------------------------------

The applicant stated that sleep problems are present in 60 percent
of patients with chronic kidney disease (CKD) and ESRD \80\ and that
patients rank fatigue and lack of energy as the most important
contributor to their decreased quality of life.\81\ Per the

[[Page 36342]]

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] 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.82 83 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.\84\ 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.
---------------------------------------------------------------------------

\80\ 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.
\81\ 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.
\82\ Morin, C.M., Belleville, G., B[eacute]langer, L., & Ivers,
H. (2011). The Insomnia Severity Index: Psychometric indicators to
detect insomnia cases and evaluate treatment response. Sleep, 34(5),
601-608.
\83\ Natale, V., Fabbri, M., Tonetti, L., & Martoni, M. (2014).
Psychometric goodness of the mini sleep questionnaire. Psychiatry
and clinical neurosciences, 68(7), 568-573.
\84\ 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.
---------------------------------------------------------------------------

The applicant stated that hypotensive symptoms such as feelings of
dizziness and lightheadedness are associated with the drops in blood
pressure that can occur during dialysis and are also among the top ten
symptoms dialysis patients report that impact their quality of
life.\85\ Per the applicant, participants in the Tablo[supreg] IDE
study were asked at the time of enrollment regarding symptoms
previously experienced during dialysis. The applicant also stated that
at the end of each study treatment, participants were surveyed
regarding the presence of any symptoms during that treatment on the
Tablo[supreg] System. Per the applicant, a total of 8 (26.7 percent)
subjects reported hypotensive symptoms during the Tablo[supreg] System
treatments during the in-home treatment period, compared to 27 (90
percent) subjects reporting hypotensive symptoms at baseline (prior to
initiating care on the Tablo[supreg] System). The applicant reported a
70 percent reduction in the rate of patient-reported hypotensive
symptoms while on the Tablo[supreg] System, though we were unable to
validate the source of this statement.
---------------------------------------------------------------------------

\85\ 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.
---------------------------------------------------------------------------

The applicant stated that currently, ESRD patients on dialysis
report meaningfully lower quality of life compared to those with other
chronic illnesses.\86\ The applicant further noted that decreased
quality of life is associated with a meaningful decline in continuation
of home therapy, dialysis frequency, and worse clinical and health care
utilization outcomes.\87\
---------------------------------------------------------------------------

\86\ Liem, Y.S., Bosch, J.L., Arends, L.R., Heijenbrok-Kal,
M.H., & Hunink, M.M. (2007). Quality of life assessed with the
Medical Outcomes Study Short Form 36-Item Health Survey of patients
on renal replacement therapy: A systematic review and meta-analysis.
Value in Health, 10(5), 390-397.
\87\ Lowrie, E.G., Curtin, R.B., LePain, N., & Schatell, D.
(2003). Medical outcomes study short form-36: A consistent and
powerful predictor of morbidity and mortality in dialysis patients.
American Journal of Kidney Diseases, 41(6), 1286-1292.
---------------------------------------------------------------------------

The applicant concluded by asserting that the totality of evidence
submitted in support of the Tablo[supreg] System demonstrates SCI over
the current standard of home dialysis care. The applicant also stated
that patient preference for devices is currently used by FDA to guide
marketing authorization decisions and provides important information on
the benefit and risks that some patients are willing to trade when
choosing a device.\88\ Per the applicant, patients may be more likely
to choose home dialysis to the extent that the device is both
accessible and easy to use. The applicant also stated that 86 percent
of prior NxStage[supreg] patients in the Tablo[supreg] IDE study found
the Tablo[supreg] System easier to use than their incumbent device and
preferred to remain on the Tablo[supreg] System at the end of the
study.\89\
---------------------------------------------------------------------------

\88\ Food and Drug Administration Center for Devices and
Radiological Health (2020). ``Patient Preference-Sensitive Areas:
Using Patient Preference Information in Medical Device Evaluation''
Available at: <a href="https://www.fda.gov/about-fda/cdrh-patient-engagement/patient-preference-sensitive-areas-using-patientpreference-information-medical-device-evaluation">https://www.fda.gov/about-fda/cdrh-patient-engagement/patient-preference-sensitive-areas-using-patientpreference-information-medical-device-evaluation</a>. Accessed Jan 21, 2021.
\89\ 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.
---------------------------------------------------------------------------

In summary, the applicant claimed that the Tablo[supreg] System
improves the treatment of Medicare beneficiaries relative to the
incumbent by focusing on outcomes set forth in Sec.
412.87(b)(1)(ii)(C), including a decreased number of treatments to
achieve dialysis adequacy, which the applicant stated leads to greater
adherence to prescribed therapy, and improved quality of life.
(c) CMS Preliminary Assessment of SCI Claims and Sources
After a review of the information provided by the applicant, we
have identified the following concerns regarding the SCI eligibility
criterion for the TPNIES. We note that, consistent with Sec.
413.236(c), CMS will announce its final determination regarding whether
Tablo[supreg] meets the SCI criterion and other eligibility criteria
for the TPNIES in the CY 2022 ESRD PPS final rule.
With respect to the applicant's claim that patients can achieve
dialysis adequacy in as little as 3 treatments per week, we note that
the Tablo[supreg] IDE study did not test whether patients receive
adequate dialysis on a thrice-weekly schedule. Instead, data published
from the Tablo[supreg] IDE study address a weekly measure of dialysis
adequacy among patients treated on a 4 times per week schedule. The
applicant relied on modeling and unpublished data on patients receiving
thrice-weekly dialysis in making the conclusion that dialysis adequacy
can be reached on a thrice-weekly schedule. Specifically, the applicant
referred to a theoretical modeling study based on historical data from
the USRDS, Medicare claims, and historical outcomes from
NxStage[supreg] observational studies. The applicant also stated that
findings from a retrospective review of 29 patients receiving treatment
with the Tablo[supreg] System on a thrice-weekly schedule affirm the
results from the modeling study. We also note that the authors in
Alvarez et al.\90\ stated that conclusions about fluid removal could
not be made from their study. We would be interested in whether
additional studies are available that address issues related to
effective fluid removal using home

[[Page 36343]]

self-care dialysis thrice-weekly with the Tablo[supreg] System. We
invite comments on whether less frequent dialysis sessions would
represent SCI over shorter, more frequent sessions that, according to
the applicant, are common among users of the incumbent technology.
---------------------------------------------------------------------------

\90\ 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, Texas.
---------------------------------------------------------------------------

The applicant's second claim was that the Tablo[supreg] System
increases adherence to dialysis treatment and retention to home
therapy, which may reduce dialysis-related hospitalizations and other
adverse events associated with missing treatment. This claim was
supported by the Tablo[supreg] IDE study (28 participants completed the
study) and the use of historical comparisons to prior studies involving
the NxStage[supreg] System. The applicant noted that hospitalization
rates from the Tablo[supreg] IDE trial were lower than rates in the
general dialysis population and rates reported in two observational
studies of patients using the NxStage[supreg] device. While the
applicant cited an all-cause hospitalization rate of 426 per 1000
patient years in the Tablo[supreg] IDE study, it does not appear that
the sources 91 92 published these hospitalization rates. We
further note that the applicant relied on historical comparisons in
asserting that that patients treated with the Tablo[supreg] System
experience reduced disease burden and improved quality of life.
---------------------------------------------------------------------------

\91\ 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.
\92\ 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.
---------------------------------------------------------------------------

We note that in the Tablo[supreg] IDE study, the before-after
comparisons in patients with NxStage[supreg] regarding improved sleep
compared to prior to the Tablo[supreg] System may be prone to recall
bias in that participants' experiences with NxStage[supreg] were not
recorded at the time they were receiving NxStage[supreg] treatments,
but rather, were based on recall at the time of the Tablo[supreg] IDE
study.
We understand that greater flexibility for patients in the way that
they receive their dialysis treatments may represent a benefit to
Medicare beneficiaries who are candidates to receive this treatment in
the home setting. We invite comments on whether this potential benefit
represents SCI, including whether the Tablo[supreg] System represents
an advance that substantially improves, relative to renal dialysis
services previously available, the treatment of Medicare beneficiaries.
(6) Capital Related Assets Criterion (Sec. 413.236(b)(6))
With respect to the sixth TPNIES eligibility criterion under Sec.
413.236(b)(6), whether the item is a capital-related asset and home
dialysis machine, Sec. 413.236(a)(2) defines these terms. First, a
capital-related asset is an asset that an ESRD facility has an economic
interest in through ownership (regardless of the manner in which it was
acquired) and is subject to depreciation. Equipment obtained by the
ESRD facility through operating leases are not considered capital-
related assets. Second, home dialysis machines are HD machines and PD
cyclers in their entirety (meaning that one new part of a machine does
not make the entire capital-related asset new) that receive FDA
marketing authorization for home use and when used in the home for a
single patient. The applicant identified the Tablo[supreg] System as an
asset that an ESRD facility has an economic interest in through
ownership, is subject to depreciation, and is an HD machine that
received FDA marketing authorization for home use. Therefore, the
Tablo[supreg] System is a capital-related asset that is a home dialysis
machine. We welcome comments on the Tablo[supreg] System's status as a
capital related asset that is a home dialysis machine.
b. CloudCath Peritoneal Dialysis Drain Set Monitoring System (CloudCath
System)
CloudCath submitted an application for the TPNIES for the CloudCath
Peritoneal Dialysis Drain Set Monitoring System (CloudCath System) for
CY 2022. According to the application, the CloudCath System is a
tabletop passive drainage system that detects and monitors solid
particles in dialysate effluent during PD treatments. Solid particles
in dialysate effluent, manifesting itself as cloudy dialysate, may
indicate that the patient has peritonitis, the inflammation of the
peritoneum in the abdominal wall usually due to a bacterial or fungal
infection.\93\ PD therapy is a common cause of peritonitis.\94\ If left
untreated, the condition can be life threatening.\95\
---------------------------------------------------------------------------

\93\ Mayo Clinic Staff, ``Peritonitis,'' June 18, 2020,
available at: <a href="https://www.mayoclinic.org/diseases-conditions/peritonitis/symptoms-causes/syc-20376247">https://www.mayoclinic.org/diseases-conditions/peritonitis/symptoms-causes/syc-20376247</a>.
\94\ Ibid.
\95\ Ibid.
---------------------------------------------------------------------------

PD-related peritonitis is a major complication and challenge to the
long-term success and adherence of patients on PD therapy.\96\ The
applicant stated that only about 12 percent of eligible patients are on
PD therapy.\97\ The applicant claimed that the risk of PD-related
peritonitis, and the challenges to detect it, are the main reasons for
these figures. The guidelines for diagnosis of PD-related peritonitis,
as outlined by the International Society for Peritoneal Dialysis
(ISPD), recommend that peritonitis be diagnosed when at least 2 of the
following criteria are present: (1) The patient experiences clinical
features consistent with peritonitis (abdominal pain and/or cloudy
dialysate effluent); (2) the patient's dialysate effluent has a whole
blood count (WBC) >100 cells/[mu]L or >0.1 x 10/L with
polymorphonuclear (PMN) cells >50 percent; and (3) positive dialysis
effluent culture is identified.\98\ Additionally, the guidelines
recommend that PD patients presenting with cloudy effluent be presumed
to have peritonitis and treated as such until the diagnosis can be
confirmed or excluded.\99\ Per the guidelines, this means that for
patients undergoing PD treatments at home, it is recommended that they
self-monitor for symptoms of peritonitis, cloudy dialysate and/or
abdominal pain, and seek medical attention for additional testing and
treatment upon experiencing any or both of these symptoms. According to
the applicant, despite the fact that peritonitis is highly prevalent,
symptom monitoring is insensitive and non-specific, which can
contribute to late presentation for medical attention and treatment.
The applicant asserted that under the current standard of care, PD
patients face the following challenges in detecting peritonitis. First,
the applicant stated that patients' fluid observation has low
compliance rates as it relies on patients' close examination of their
own dialysate effluent during PD treatments, which often occur while
patients are asleep. Second, the applicant noted that it can be
difficult for patients to visually detect peritonitis in dialysate
effluent using a ``newspaper test'' for cloudiness, and can be even
more difficult to see when the fluid is drained into a toilet, where it
is diluted by water. The applicant stated that, as a result of these
challenges, patients with ESRD suffer unsatisfactorily high mortality
and morbidity from

[[Page 36344]]

peritonitis, as well as high rates of PD modality loss, meaning they
must discontinue PD and begin a different type of dialysis treatment.
Per the applicant, the CloudCath System addresses these challenges by
detecting changes in dialysate effluent at much lower levels of
particle concentrations than the amount needed to accumulate for visual
detection by patients.
---------------------------------------------------------------------------

\96\ Kam-Tao Li, Philip, et al., ``ISPD Peritonitis
recommendations: 2016 Update on Prevention and Treatment,''
Peritoneal Dialysis International 2016; 36(5):481-508, June 9, 2016,
available at: <a href="http://dx.doi.org/10.3747/pdi.2016.00078">http://dx.doi.org/10.3747/pdi.2016.00078</a>.
\97\ Briggs, et al., ``Early Detection of Peritonitis in
Patients Undergoing Peritoneal Dialysis: A Device and Cloud-Based
Algorithmic Solution,'' unpublished report.
\98\ Kam-Tao Li, Philip, et al., ``ISPD Peritonitis
recommendations: 2016 Update on Prevention and Treatment,''
Peritoneal Dialysis International 2016; 36(5):481-508, June 9, 2016,
available at: <a href="http://dx.doi.org/10.3747/pdi.2016.00078">http://dx.doi.org/10.3747/pdi.2016.00078</a>.
\99\ Ibid.
---------------------------------------------------------------------------

Per the applicant, the CloudCath System consists of three
components: (1) Drain set, (2) sensor, and (3) patient monitoring
software. As explained in the application, the CloudCath System's drain
set connects to a compatible PD cycler's drain line to enable draining
and monitoring of dialysate effluent before routing the fluid to the
drainage receptacle. Per the CloudCath System User Guide, included in
the application, the CloudCath System is compatible with the following
PD cyclers: Baxter Healthcare Home Choice PROTM, Baxter
Healthcare AMIATM Automated PD System, and Fresenius
Liberty[supreg] Select Cycler. Per the applicant, once the CloudCath
System is attached to a compatible cycler, the dialysate effluent runs
through the drain set, through the CloudCath System's optical sensor.
The applicant explained that the CloudCath System's optical sensor
detects and monitors changing concentrations of solid particles in the
dialysate effluent during each dialysis cycle and reports the
concentrations in a turbidity score. Per the applicant, the CloudCath
System will indicate whether dialysate effluent has normal turbidity
and will notify the patient and/or health care professional if the
dialysate effluent turbidity has exceeded the notification threshold
set by the patient's dialysis provider. The applicant stated that the
optical sensor's hardware and software components allow for data
trending over time and remote monitoring by a healthcare professional.
(1) Renal Dialysis Service Criterion (Sec. 413.236(b)(1))
Regarding the first TPNIES eligibility criterion in Sec.
413.236(b)(1), that the item has been designated by CMS as a renal
dialysis service under Sec. 413.171, monitoring for peritonitis is a
service that is essential for dialysis, and therefore would be
considered a renal dialysis service under Sec. 413.171.
(2) Newness Criterion (Sec. 413.236(b)(2))
With respect to the second TPNIES eligibility criterion in Sec.
413.236(b)(2), that the item is new, meaning within 3 years beginning
on the date of the FDA marketing authorization, the applicant stated
that it is seeking 510(k) marketing authorization from the FDA. To be
eligible for the TPNIES, the applicant must apply within three years of
the FDA marketing authorization date and receive FDA marketing
authorization by the HCPCS Level II deadline of July 6, 2021. The
applicant stated that it anticipates the CloudCath System will receive
FDA marketing authorization by the HCPCS Level II deadline.
(3) Commercial Availability Criterion (Sec. 413.236(b)(3))
Regarding the third TPNIES eligibility criterion in Sec.
413.236(b)(3), that the item is commercially available by January 1 of
the particular calendar year, meaning the year in which the payment
adjustment would take effect, the applicant stated that the CloudCath
System is not currently commercially available because it has not
received FDA marketing authorization. The applicant noted that it
expects the CloudCath System will be commercially available immediately
after receiving FDA marketing authorization.
(4) HCPCS Level II Application Criterion (Sec. 413.236(b)(4))
Regarding the fourth TPNIES eligibility criterion in Sec.
413.236(b)(4) requiring that the applicant submit a complete HCPCS
Level II code application by the HCPCS Level II application deadline of
July 6, 2021, the applicant stated that it has not submitted an
application yet, but intends to apply by the deadline.
(5) Innovation Criteria (Sec. Sec. 413.236(b)(5) and 412.87(b)(1))
(a) SCI Claims and Sources
With regard to the fifth TPNIES eligibility criterion under Sec.
413.236(b)(5), that the item is innovative, meaning it meets the SCI
criteria specified in Sec. 412.87(b)(1), the applicant asserted that
the CloudCath System offers SCI over technologies currently available
for the Medicare patient population by offering the ability to monitor
changes in turbidity of peritoneal dialysate effluent through
continuous remote monitoring in patients with ESRD receiving PD
therapy, earlier than the current standard of care. By allowing the
clinical standard of care to be initiated earlier, per the applicant,
the use of the CloudCath System changes the management of peritonitis
patients by enabling clinicians to both diagnose peritonitis and
initiate antibiotic treatment earlier.
The applicant submitted two studies on the technology in support of
the SCI claims. The applicant included a preliminary, unpublished
report by Briggs, et al. on a clinical study that tested the ability of
the CloudCath System and its dialysate effluent monitoring algorithm to
detect indicators of peritonitis.\100\ The proof of principle
observational study consisted of 70 PD patients outside of the U.S. who
had been on PD for a long interval of time (>10 days), and thus were at
an increased risk of developing peritonitis. Out of the 64 PD patients
whose data were included in the study, over 40 PD patients were
receiving intermittent PD, which is not commonly used in the U.S. The
remainder of the participants were receiving Continuous Ambulatory
Peritoneal Dialysis. The report states that in the U.S., PD is
generally performed in a modality called Continuous Cycling Peritoneal
Dialysis (CCPD), in which a cycler automatically administers multiple
dialysis exchange cycles, typically while patients sleep. Samples were
collected from patients' PD effluent drainage bags and measured in the
CloudCath System against a proprietary Turbidity Score threshold value
and also tested for reference laboratory measurements according to ISPD
guidelines for WBC count and differential (>100 cells/[mu]L, >50
percent PMN).\101\ Regarding the Turbidity Score threshold value, the
study set a score to determine if the effluent sample in the CloudCath
System was infected or not; samples greater than or equal to the
Turbidity Score threshold value would be classified as infected, and
samples less than the Turbidity Score threshold value would be
classified as non-infected. The crude sensitivity and specificity of
the CloudCath System was 96.2 percent and 91.2 percent, respectively. A
majority of false positives (44 of 77 samples) occurred among patients
already receiving antibiotic treatment for peritonitis, and another 20
false positive reports occurred because the patient had elevated
turbidity due to a cause other than peritonitis. The investigators
subsequently removed samples from patients already receiving treatment
for peritonitis, setting the sensitivity for detecting peritonitis
using the CloudCath System at 99 percent and the specificity at 97.6
percent.
---------------------------------------------------------------------------

\100\ Briggs, et al., ``Early Detection of Peritonitis in
Patients Undergoing Peritoneal Dialysis: A Device and Cloud-Based
Algorithmic Solution,'' unpublished report.
\101\ Kam-Tao Li, Philip, et al., ``ISPD Peritonitis
recommendations: 2016 Update on Prevention and Treatment,''
Peritoneal Dialysis International 2016; 36(5):481-508, June 9, 2016,
available at: <a href="http://dx.doi.org/10.3747/pdi.2016.00078">http://dx.doi.org/10.3747/pdi.2016.00078</a>.
---------------------------------------------------------------------------

The second study the applicant submitted is the Prospective
Clinical Study to Evaluate the Ability of the CloudCath System to
Detect Peritonitis

[[Page 36345]]

Compared to Standard of Care during In-Home Peritoneal Dialysis
(CATCH).\102\ CloudCath initiated this ongoing single-arm, open-label,
multi-center study to demonstrate that the CloudCath System is able to
detect changes in turbidity associated with peritonitis in PD patients
prior to laboratory diagnosis of peritonitis with a high degree of
specificity and sensitivity. The target enrollment is 186 participants
over 18 years of age using CCPD as their PD modality, with at least 2
exchanges per night.\103\ Patients with active infection and/or cancer
are excluded from the trial.\104\ The primary endpoint is time of
peritonitis detection by the CloudCath System (defined as two
consecutive Turbidity Scores >7.0) as compared to laboratory evidence
of peritonitis (defined as WBC count >100 cells/[mu]L or >0.1 x 109/L
with percentage of PMN >50 percent).\105\ While the study is ongoing,
the applicant included the study protocol and preliminary results with
its application.\106\ The preliminary results demonstrate that as of
December 29, 2020, 132 participants have been enrolled in the CATCH
Study at 13 sites.\107\ Of the 132 enrolled participants, 59.1 percent
of participants were male, 65.9 percent of participants were White and
29.6 percent of participants were Black or African American.\108\
Enrolled participants underwent an average of 4.5 exchanges per
night.\109\ The preliminary results indicate that, as of December 29,
2020, there have been 7 peritonitis events that met the ISPD peritoneal
fluid cell counts and differentials standard.\110\ All 7 of the
peritonitis events were also detected by the CloudCath System.\111\ In
5 out of the 7 peritonitis events, the CloudCath System detected
peritonitis 44 to 368 hours prior to the time of detection from a
clinical laboratory.\112\ The CloudCath System also detected
peritonitis 27 to 344 hours prior to participants presenting to the
hospital or clinic with signs or symptoms of peritonitis.\113\ The
applicant stated that these results support the claim that the
CloudCath System would enable diagnosis of peritonitis earlier than the
current standard of care through turbidity monitoring.
---------------------------------------------------------------------------

\102\ CloudCath, ``A Prospective Clinical Study to Evaluate the
Ability of the CloudCath System to Detect Peritonitis Compared to
Standard of Care during In-Home Peritoneal Dialysis (CATCH),''
Preliminary Clinical Study Report (NCT04515498), Jan 27, 2020.
\103\ CloudCath, ``A Prospective Clinical Study to Evaluate the
Ability of the CloudCath System to Detect Peritonitis Compared to
Standard of Care during In-Home Peritoneal Dialysis (CATCH),'' Study
Protocol (CC-P-001), June 24, 2020.
\104\ Ibid.
\105\ Ibid.
\106\ CloudCath, ``A Prospective Clinical Study to Evaluate the
Ability of the CloudCath System to Detect Peritonitis Compared to
Standard of Care during In-Home Peritoneal Dialysis (CATCH),''
Preliminary Clinical Study Report (NCT04515498), Jan 27, 2020.
\107\ Ibid.
\108\ Ibid.
\109\ Ibid.
\110\ Ibid.
\111\ Ibid.
\112\ Ibid.
\113\ Ibid.
---------------------------------------------------------------------------

In addition to the studies on the technology, the applicant
submitted an article by Muthucumarana, et al. on the impact of time-to-
treatment on clinical outcomes of PD-related peritonitis.\114\ The
article includes data from the Presentation and the Time of Initial
Administration of Antibiotics With Outcomes of Peritonitis (PROMPT)
Study, a prospective multicenter from 2012 to 2014 that observed
symptom-to-contact time, contact-to-treatment time, defined as the time
from health care presentation to initial antibiotic, and symptom-to-
treatment time in Australian PD patients. 116 patients participated in
the survey, 83 of which were caucasian and 14 were aboriginal.\115\ Out
of the sample size of 116 survey participants, there were 159 episodes
of PD-related peritonitis. Of these, 38 patient episodes met the
primary outcome of PD failure (defined as catheter removal or death) at
30 days.\116\ The median symptom-to-treatment time was 9.0 hours in all
patients, 13.6 hours in the PD-fail group, and 8.0 hours in the PD-cure
group.\117\ The study found that the risk of PD-failure increased by
5.5 percent for each hour of delay of administration of antibiotics
once patients presented to a health care provider.\118\ However,
neither symptom-to-contact nor symptom-to-treatment was associated with
PD-failure in non-adjusted analyses, and the time from presentation to
a health care provider to treatment was only associated with PD-failure
outcomes in multivariable-adjusted analyses in a subset of patients who
presented to hospital-based facilities. In addition to the
Muthucumarana et al. article, the applicant cited to other studies that
have found that antibiotic treatment should begin as soon as possible
in order to effectively treat infections other than
peritonitis.119 120 121 Per the applicant, these articles on
time-to-treatment demonstrate that the CloudCath System's ability to
detect effluent changes substantially earlier improves the standard of
care, enabling PD-related peritonitis diagnosis and antibiotic
treatment earlier while decreasing the likelihood of PD-failure due to
PD-related peritonitis.
---------------------------------------------------------------------------

\114\ Muthucumarana, et al., ``The Relationship Between
Presentation and the Time of Initial Administration of Antibiotics
With Outcomes of Peritonitis in Peritoneal Dialysis Patients: The
PROMPT Study.,'' Kidney Int Rep. 2016 Jun 11;1(2):65-72. doi:
10.1016/j.ekir.2016.05.003. PMID: 29142915; PMCID: PMC5678844.
\115\ Ibid.
\116\ Ibid.
\117\ Ibid.
\118\ Ibid.
\119\ Gacouin, A. et al., ``Severe pneumonia due to Legionella
pneumophila: prognostic factors, impact of delayed appropriate
antimicrobial therapy,'' Intensive Care Medicine 28, 686-691 (2002),
<a href="https://doi.org/10.1007/s00134-002-1304-8">https://doi.org/10.1007/s00134-002-1304-8</a>.
\120\ Houck, PM. et al., ``Timing of antibiotic administration
and outcomes for Medicare patients hospitalized with community-
acquired pneumonia,'' Arch Intern Med. 2004 Mar 22;164(6):637-44.
doi: 10.1001/archinte.164.6.637. PMID: 15037492.
\121\ Lodise TP, et al., ``Outcomes analysis of delayed
antibiotic treatment for hospital-acquired Staphylococcus aureus
bacteremia,''Clin Infect Dis. 2003 Jun 1;36(11):1418-23. doi:
10.1086/375057. Epub 2003 May 20. PMID: 12766837.
---------------------------------------------------------------------------

The applicant also submitted letters of support from a nephrologist
at an academic institution and the following ESRD patient advocacy
groups: The American Kidney Fund, the American Association of Kidney
Patients, and the International Society of Nephrology. The letter of
support from Dr. Thomas A. Golper, president-elect of the International
Society of Nephrology, endorsed the CloudCath System's ability to
detect peritonitis and enable clinicians to begin to treat the
infection earlier, preventing hospitalizations and related
complications such as the abandonment of home dialysis. The letter also
stated that the CloudCath System helps address the challenge of
peritonitis as the main reason for abandonment of PD for HD, and will
encourage a greater number of patients to select PD as their dialysis
modality of choice. The letters from the American Association of Kidney
Patients and the International Society of Nephrology encouraged CMS to
consider the CloudCath System's application, explaining that the
technology would have several benefits to patients, for example, by
reducing peritonitis-related hospitalizations, increasing adherence to
PD, and encouraging higher utilization of PD as a viable alternative to
in-center HD. The American Kidney Fund's letter emphasized that
peritonitis is a significant concern for PD patients \122\ and
requested CMS support of all efforts that ensure patients

[[Page 36346]]

with ESRD undergoing PD treatments can quickly detect and treat
infections.
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\122\ Mehrotra, Rajnish et al., ``The Current State of
Peritoneal Dialysis,'' Journal of the American Society of Nephrology
27: 3238-3252, 2016. doi: 10.1681/ASN.2016010112, available at:
<a href="https://jasn.asnjournals.org/content/jnephrol/27/11/3238.full.pdf?with-ds=yes">https://jasn.asnjournals.org/content/jnephrol/27/11/3238.full.pdf?with-ds=yes</a>.
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(b) CMS Preliminary Assessment of SCI Claims and Sources
After a review of the information provided by the applicant, we
note the following concerns with regard to the SCI criterion under
Sec. 413.236(b)(5) and Sec. 412.87(b)(1). We note that, consistent
with Sec. 413.236(c), CMS will announce its final determination
regarding whether the CloudCath System meets the SCI criterion and
other eligibility criteria for the TPNIES in the CY 2022 ESRD PPS final
rule.
Because the applicant claims to offer the ability to diagnose a
medical condition, PD-related peritonitis, earlier in a patient
population than allowed by currently available methods, the applicant
must also include evidence that use of the new technology to make a
diagnosis affects the management of the patient, as required under the
SCI criterion at Sec. 412.87(b)(1)(ii)(B). Specifically, Sec.
412.87(b)(1)(ii)(B) states that a determination that a technology
represents SCI over existing technology means: The new medical service
or technology 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 medical
service or technology to make a diagnosis affects the management of the
patient.
It is not clear to us whether the studies submitted demonstrate or
examine the impacts of using the technology on patients with ESRD such
that we can determine whether it represents an advance that
substantially improves the treatment of Medicare beneficiaries compared
to renal dialysis services previously available. We note that the
studies submitted serve as ``proof of concept,'' as they provide
evidence that the CloudCath System detects solid particles in dialysate
effluent that may indicate PD-related peritonitis, and, may do so
earlier than patient observation and a cell count test. However, the
studies are limited in that they do not observe how the CloudCath
System, in detecting the solid particles in dialysate effluent and
doing so earlier than a cell count test, affects the management of the
patient, as required under the SCI criterion at Sec.
412.87(b)(1)(ii)(B). For example, as part of the CATCH Study,
investigators deactivated the notification capability of the CloudCath
System for the duration of the study, so that neither the participants
nor the investigators would be aware of the device measurements.\123\
Therefore, the CATCH study did not examine patient and clinician
behavior, including the medical management of the patient, after the
CloudCath System detected the solid particles in the dialysate
effluent. The Briggs et al. study also did not examine how use of the
CloudCath System impacted management of the patient. The investigators
in that study stated, ``none of the data from our device was used for
clinical decision making,'' meaning that the study did not test how or
if the CloudCath

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