Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive Program, 31190-31233 [2017-13908]
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31190
Federal Register / Vol. 82, No. 127 / Wednesday, July 5, 2017 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 413 and 414
[CMS–1674–P]
RIN 0938–AT04
Medicare Program; End-Stage Renal
Disease Prospective Payment System,
Payment for Renal Dialysis Services
Furnished to Individuals With Acute
Kidney Injury, and End-Stage Renal
Disease Quality Incentive Program
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
This rule proposes to update
and make revisions to the End-Stage
Renal Disease (ESRD) Prospective
Payment System (PPS) for calendar year
(CY) 2018, as well as to update the
payment rate for renal dialysis services
furnished by an ESRD facility to
individuals with acute kidney injury
(AKI). This rule also proposes to set
forth requirements for the ESRD Quality
Incentive Program (QIP), including for
payment years (PYs) 2019 through 2021.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. August 28, 2017.
ADDRESSES: In commenting, please refer
to file code CMS–1674–P. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. 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–1674–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–1674–P, Mail
Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. Alternatively,
you may deliver (by hand or courier)
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your written comments ONLY to the
following addresses prior to the close of
the comment period:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1810.
If you intend to deliver your
comments to the Baltimore address, call
telephone number (410) 786–9994 in
advance to schedule your arrival with
one of our staff members.
Comments erroneously mailed to the
addresses indicated as appropriate for
hand or courier delivery may be delayed
and received after the comment period.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
ESRDPayment@cms.hhs.gov, for issues
related to the ESRD PPS and coverage
and payment for renal dialysis services
furnished to individuals with AKI.
Delia Houseal, (410) 786–2724, for
issues related to the ESRD QIP.
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 Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
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through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
Electronic Access
This Federal Register document is
also available from the Federal Register
online database through Federal Digital
System (FDsys), a service of the U.S.
Government Printing Office. This
database can be accessed via the
internet at https://www.gpo.gov/fdsys/.
Table of Contents
To assist readers in referencing
sections contained in this preamble, we
are providing a Table of Contents. Some
of the issues discussed in this preamble
affect the payment policies, but do not
require changes to the regulations in the
Code of Federal Regulations (CFR).
I. Executive Summary
A. Purpose
1. End-Stage Renal Disease (ESRD)
Prospective Payment System (PPS)
2. Coverage and Payment for Renal Dialysis
Services Furnished to Individuals With
Acute Kidney Injury (AKI)
3. End-Stage Renal Disease (ESRD) Quality
Incentive Program (QIP)
B. Summary of the Major Provisions
1. ESRD PPS
2. Payment for Renal Dialysis Services
Furnished to Individuals With AKI
3. ESRD QIP
C. Summary of Cost and Benefits
1. Impacts of the Proposed ESRD PPS
2. Impact of the Proposed Payment for
Renal Dialysis Services Furnished to
Individuals With AKI
3. Impacts of the Proposed ESRD QIP
II. Calendar Year (CY) 2018 End-Stage Renal
Disease (ESRD) Prospective Payment
System (PPS)
A. Background
1. Statutory Background
2. System for Payment of Renal Dialysis
Services
3. Updates to the ESRD PPS
B. Provisions of the Proposed Rule
1. Pricing Eligible Outlier Drugs and
Biologicals That Were or Would Have
Been, Prior to January 1, 2011,
Separately Billable Under Medicare Part
B
a. Summary of Outlier Calculation
b. Use of ASP Methodology Under the
ESRD PPS
c. Pricing Methodologies Under Section
1847A of the Act
d. Proposal for Pricing Eligible Outlier
Drugs and Biologicals That Were or
Would Have Been, Prior to January 1,
2011, Separately Billable Under
Medicare Part B
2. Proposed CY 2018 ESRD PPS Update
a. ESRD Bundled Market Basket
i. Proposed CY 2018 ESRD Market Basket
Update, Productivity Adjustment, and
Labor-Related Share for ESRD PPS
ii. Proposed CY 2018 ESRDB Market Basket
Update, Adjusted for Multifactor
Productivity (MFP)
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b. The Proposed CY 2018 ESRD PPS Wage
Indices
i. Annual Update of the Wage Index
ii. Application of the Wage Index Under
the ESRD PPS
c. CY 2018 Update to the Outlier Policy
i. CY 2018 Update to the Outlier Services
MAP Amounts and FDL Amounts
ii. Outlier Percentage
d. Proposed Impacts to the CY 2018 ESRD
PPS Base Rate
i. ESRD PPS Base Rate
ii. Annual Payment Rate Update for CY
2018
III. CY 2018 Payment for Renal Dialysis
Services Furnished to Individuals With
Acute Kidney Injury (AKI)
A. Background
B. Annual Payment Rate Update for CY
2018
1. CY 2018 AKI Dialysis Payment Rate
2. Geographic Adjustment Factor
IV. End-Stage Renal Disease (ESRD) Quality
Incentive Program (QIP) for Payment
Year (PY) 2021
A. Background
B. Accounting for Social Risk Factors in
the ESRD QIP Program
C. Proposed Change to the Performance
Score Certificate Beginning With the
Payment Year (PY) 2019 ESRD QIP
D. Proposed Requirements Beginning With
the PY 2020 ESRD QIP
1. Proposal To Clarify the Minimum Data
Policy for Scoring Measures Finalized for
the PY 2020 ESRD QIP
2. Proposed Changes to the Extraordinary
Circumstances Exception (ECE) Policy
3. Solicitation of Comments on the
Inclusion of Acute Kidney Injury (AKI)
Patients in the ESRD QIP
4. Estimated Performance Standards,
Achievement Thresholds, and
Benchmarks for the Clinical Measures
Finalized for the PY 2020 ESRD QIP
5. Policy for Weighting the Clinical
Measure Domain for PY 2020
6. Proposed Payment Reductions for the PY
2020 ESRD QIP
7. Data Validation
E. Proposed Requirements for the PY 2021
ESRD QIP
1. Proposed Measures for the PY 2021
ESRD QIP
2. Proposed Replacement of the Vascular
Access Type (VAT) Clinical Measures
Beginning With the PY 2021 Program
Year
3. Proposed Revision of the Standardized
Transfusion Ratio (STrR) Clinical
Measure Beginning With the PY 2021
Program Year
4. Proposed New Vascular Access
Measures Beginning With the PY 2021
ESRD QIP
a. Proposed New Hemodialysis Vascular
Access: Standardized Fistula Rate
Clinical Measure (NQF #2977)
b. Proposed New Hemodialysis Vascular
Access: Long-Term Catheter Rate (NQF
#2978) Beginning With the PY 2021
ESRD QIP
5. Proposed Performance Period for the PY
2021 ESRD QIP
6. Proposed Performance Standards,
Achievement Thresholds, and
Benchmarks for the PY 2021 ESRD QIP
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a. Proposed Performance Standards,
Achievement Thresholds, and
Benchmarks for the Clinical Measures in
the PY 2021 ESRD QIP
b. Performance Standards, Achievement
Thresholds, and Benchmarks for the
Clinical Measures Proposed for the PY
2021 ESRD QIP
c. Proposed Performance Standards for the
PY 2021 Reporting Measures
7. Proposal for Scoring the PY 2021 ESRD
QIP
a. Scoring Facility Performance on Clinical
Measures Based on Achievement
b. Proposal for Scoring Facility
Performance on Clinical Measures Based
on Improvement
c. Scoring the ICH CAHPS Clinical
Measure
d. Proposal for Scoring the Proposed
Hemodialysis Vascular Access:
Standardized Fistula Rate and LongTerm Catheter Rate Measures and the
Vascular Access Measure Topic
e. Proposal for Calculating Facility
Performance on Reporting Measures
8. Proposal for Weighting the Clinical
Measure Domain, and Weighting the TPS
a. Proposal for Weighting the Clinical
Measure Domain for PY 2021
b. Proposal for Weighting the Domains
Used To Calculate the TPS
9. Example of the Proposed PY 2021 ESRD
QIP Scoring Methodology
10. Proposed Minimum Data for Scoring
Measures for the PY 2021 ESRD QIP
11. Proposed Payment Reductions for the
PY 2021 ESRD QIP
V. Advancing Health Information Exchange
VI. Collection of Information Requirements
A. Legislative Requirement for the
Solicitation of Comments
B. Requirements in Regulation Text
C. Additional Information Collection
Requirements
1. ESRD QIP
a. Wage Estimates
b. Time Required To Submit Data Based on
Proposed Reporting Requirements
c. Data Validation Requirements for the PY
2020 ESRD QIP
VII. Request for Information on Medicare
Flexibilities and Efficiencies
VIII. Response to Comments
IX. Economic Analyses
A. Regulatory Impact Analysis
1. Introduction
2. Statement of Need
3. Overall Impact
B. Detailed Economic Analysis
1. CY 2018 End-Stage Renal Disease
Prospective Payment System
a. Effects on ESRD Facilities
b. Effects on Other Providers
c. Effects on the Medicare Program
d. Effects on Medicare Beneficiaries
e. Alternatives Considered
2. Proposed Payment for Renal Dialysis
Services Furnished to Individuals With
AKI
a. Effects on ESRD Facilities
b. Effects on Other Providers
c. Effects on the Medicare Program
d. Effects on Medicare Beneficiaries
e. Alternatives Considered
3. ESRD QIP
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a. Effects of the PY 2021 ESRD QIP on
ESRD Facilities
b. Effects on Other Providers
c. Effects on the Medicare Program
d. Effects on Medicare Beneficiaries
e. Alternatives Considered
C. Accounting Statement
X. Regulatory Flexibility Act Analysis
XI. Unfunded Mandates Reform Act Analysis
XII. Federalism Analysis
XIII. Reducing Regulation and Controlling
Regulatory Costs
XIV. Congressional Review Act
XV. Files Available to the Public via the
Internet
Acronyms
Because of the many terms to which
we refer by acronym in this proposed
rule, we are listing the acronyms used
and their corresponding meanings in
alphabetical order below:
Affordable Care Act the Patient Protection
and Affordable Care Act
ABLE Stephen Beck, Jr., Achieving a Better
Life Experience Act of 2014
AKI Acute Kidney Injury
AMP Average Manufacturer Price
ASP Average Sales Price
ATRA American Taxpayer Relief Act of
2012
BLS Bureau of Labor Statistics
BSI Bloodstream Infection
CBSA Core Based Statistical Area
CCN CMS Certification Number
CDC Centers for Disease Control and
Prevention
CEO Chief Executive Officer
CFR Code of Federal Regulations
CMS Centers for Medicare & Medicaid
Services
CROWNWeb Consolidated Renal
Operations in a Web-Enabled Network
CY Calendar Year
DFR Dialysis Facility Report
ECE Extraordinary Circumstances
Exception
EPO Epoetin
ESA Erythropoiesis stimulating agent
ESRD End-Stage Renal Disease
ESRDB End-Stage Renal Disease Bundled
ESRD PPS End-Stage Renal Disease
Prospective Payment System
ESRD QIP End-Stage Renal Disease Quality
Incentive Program
FFS Fee-For-Service
FDA Food and Drug Administration
FDL Fixed-Dollar Loss
ICD International Classification of Diseases
ICH CAHPS In-Center Hemodialysis
Consumer Assessment of Healthcare
Providers and Systems
IGI IHS Global Inc.
IPPS Inpatient Prospective Payment System
IQR Interquartile Range
Kt/V A measure of dialysis adequacy where
K is dialyzer clearance, t is dialysis time,
and V is total body water volume
MAP Medicare Allowable Payment
MFP Multifactor Productivity
MIPPA Medicare Improvements for Patients
and Providers Act of 2008 (Pub. L. 110–
275)
NHSN National Healthcare Safety Network
NQF National Quality Forum
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OMB Office of Management and Budget
PAMA Protecting Access to Medicare Act of
2014
PPS Prospective Payment System
PY Payment Year
QIP Quality Incentive Program
RFA Regulatory Flexibility Act
SBA Small Business Administration
SHR Standardized Hospitalization Ratio
SRR Standardized Readmission Ratio
STrR Standardized Transfusion Ratio
TCV Truncated Coefficient of Variation
TDAPA Transitional Drug Add-on Payment
Adjustment
TEP Technical Expert Panel
The Act Social Security Act
The Secretary Secretary of the Department
of Health and Human Services
TPEA Trade Preferences Extension Act of
2015
TPS Total Performance Score
VAT Vascular Access Type
WAMP Widely Available Market Price
I. Executive Summary
A. Purpose
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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 prospective
payment system for renal dialysis
services furnished by ESRD facilities.
This rule proposes to update and make
revisions to the ESRD PPS for calendar
year (CY) 2018. 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), and 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
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.
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 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
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with AKI. Section 808(b) of 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.
3. End-Stage Renal Disease (ESRD)
Quality Incentive Program (QIP)
This rule also proposes to set forth
requirements for the end-stage renal
disease (ESRD) quality incentive
program (QIP), including for payment
years (PYs) 2019, 2020, and 2021. The
program is authorized under section
1881(h) of the Social Security Act (the
Act). The ESRD QIP is the most recent
step in fostering improved patient
outcomes by establishing incentives for
dialysis facilities to meet or exceed
performance standards established by
the Centers for Medicare & Medicaid
Services (CMS).
B. Summary of the Major Provisions
1. ESRD PPS
• Update to the ESRD PPS base rate
for CY 2018: The proposed CY 2018
ESRD PPS base rate is $233.31. This
amount reflects a reduced market basket
increase as required by section
1881(b)(14)(F)(i)(I) of the Act (0.7
percent), and application of the wage
index budget-neutrality adjustment
factor (1.000605), equaling $233.31
($231.55 × 1.007 × 1.000605 = $233.31).
• 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 2018, we are not
proposing any changes to the
application of the wage index floor and
we propose to continue to apply the
current wage index floor (0.4000) to
areas with wage index values below the
floor.
• Update to the outlier policy:
Consistent with our proposal to
annually update the outlier policy using
the most current data, we are proposing
to update the outlier services fixeddollar loss (FDL) amounts for adult and
pediatric patients and Medicare
Allowable Payment (MAP) amounts for
adult and pediatric patients for CY 2018
using CY 2016 claims data. Based on the
use of more current data, the FDL
amount for pediatric beneficiaries
would decrease from $68.49 to $49.55
and the MAP amount would decrease
from $38.29 to $38.25, as compared to
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CY 2017 values. For adult beneficiaries,
the FDL amount would increase from
$82.92 to $83.12 and the MAP amount
would decrease from $45.00 to $42.70.
The 1 percent target for outlier
payments was not achieved in CY 2016.
Outlier payments represented
approximately 0.78 percent of total
payments rather than 1.0 percent. We
believe using CY 2016 claims data to
update the outlier MAP and FDL
amounts for CY 2018 would increase
payments for ESRD beneficiaries
requiring higher resource utilization in
accordance with a 1 percent outlier
percentage.
• Update to the pricing of drugs and
biologicals under the outlier policy: We
are proposing a change to the ESRD PPS
outlier policy to allow the use of any
pricing methodology available under
section 1847A of the Act to determine
the cost of certain eligible outlier service
drugs and biologicals in computing
outlier payments when average sales
price (ASP) data is not available.
2. Payment for Renal Dialysis Services
Furnished to Individuals With AKI
We are proposing to update the AKI
payment rate for CY 2018. The proposed
CY 2018 payment rate is $233.31, which
is the same base rate proposed under the
ESRD PPS.
3. ESRD QIP
This rule proposes to set forth
requirements for the ESRD QIP,
including for payment years (PYs) 2019,
2020 and 2021 as follows:
• Updating the Performance Score
Certificate Beginning in PY 2019: In
section IV.C of this proposed rule, we
set forth the updates we are proposing
to make to the Performance Score
Certificate (PSC) beginning in PY 2019.
Specifically, in response to feedback
from stakeholders about the length and
complexity of the PSC, and in an effort
to make the document more effective
and understandable for the community,
we propose to shorten and simplify the
PSC. Specifically, we are proposing to
shorten the PSC by removing some of
the information we had previously
finalized would be included in the
document. We are proposing that the
revised PSC would indicate the facility’s
TPS, as required under section
1881(h)(6)(c) of the Act, as well as
information sufficient to identify the
facility and information showing how
the facility’s TPS compared to the
national average TPS for that specific
payment year. We are not making any
proposals to change the other
requirements associated with this
document. Facilities would still be
required to post their PSC in a public
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location in both English and Spanish
(77 FR 67517).
• Proposed Changes to the
Extraordinary Circumstances Exception
(ECE) Policy: In section IV.D.2 of this
proposed rule, we set forth the updates
we are proposing to the Extraordinary
Circumstances Exception (ECE) Policy
for the ESRD QIP. In an effort to bring
our policy into alignment with other
quality reporting and value based
purchasing programs, we are proposing
to (1) allow facilities to submit a form
signed by the facility’s CEO or
designated personnel; (2) expand the
reasons for which an ECE can be
requested by a facility or granted by
CMS of its own accord to include an
unresolved issue with a CMS data
system, which affected the ability of the
facility to submit data (an unresolved
data system issue, in this case, would be
one which did not allow the facility to
submit data by the data submission
deadline and one which was unable to
be resolved with a work-around); and
(3) specify that a facility does not need
to be closed in order to request and
receive consideration for an ECE, as
long as the facility can demonstrate that
its normal operations have been
significantly affected by an
extraordinary circumstance outside of
its control. We are also clarifying that
our intent is to notify a facility of our
decision on a facility’s ECE request
within 90 days of the date that we
receive it.
• Proposed PY 2021 Measure Set: As
discussed in section IV.E.1 of this
proposed rule, in the CY 2017 ESRD
PPS final rule (81 FR 77834 through
77969), we previously finalized 16
measures to be included in the PY 2020
ESRD QIP. For PY 2021, we are
proposing to update the Standardized
Transfusion Ratio (STrR) Clinical
Measure to bring the measure into
alignment with the National Quality
Forum (NQF)-endorsed specifications,
and replace the two existing Vascular
Access Type (VAT) measures with
newly endorsed vascular access
measures that address long-held
concerns of the community.
Specifically, we are proposing to replace
the VAT measures with the Proposed
Hemodialysis Vascular Access:
Standardized Fistula Rate Clinical
Measure and the Proposed
Hemodialysis Vascular Access: LongTerm Catheter Rate Clinical Measure.
There would be no increase in burden
associated with the proposed measure
changes.
• Data Validation: In section IV.D.7
of this proposed rule, we set forth the
updates we are proposing to make to the
data validation program in the ESRD
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QIP. For PY 2020, we are proposing to
continue the pilot validation study for
validation of Consolidated Renal
Operations in a Web-Enabled Network
(CROWNWeb) data. Under this
continued validation study, we are
proposing to continue using the same
methodology used for the PY 2018 and
PY 2019 ESRD QIP. Under this
methodology, we would sample
approximately 10 records per facility
from 300 facilities during CY 2018.
For PY 2020, we are proposing to
continue a National Healthcare Safety
Network (NHSN) Bloodstream Infection
(BSI) Data Validation study similar to
the one that we finalized in the CY 2017
ESRD PPS final rule. Under that
methodology, we would select 35
facilities to participate in an NHSN
dialysis event validation study for two
quarters of data reported in CY 2018.
The CMS data validation contractor
would then send these facilities requests
for medical records for all patients with
‘‘candidate events’’ during the
evaluation period, as well as randomly
selected patient records. Each facility
selected would be required to submit 10
records total to the CMS validation
contractor. The CMS contractor would
utilize a methodology for reviewing and
validating the candidate events that is
consistent with the Centers for Disease
Control and Prevention’s (CDC’s)
validation protocol, and analyze those
records to determine whether the
facility reported dialysis events for
those patients in accordance with the
NHSN Dialysis Event Protocol.
Information from the validation study
would be used to develop a
methodology to score facilities based on
the accuracy of their reporting of the
NHSN BSI Clinical Measure.
C. Summary of Costs and Benefits
In section IX 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 chart in section IX of this
proposed rule displays the estimated
change in payments to ESRD facilities in
CY 2018 compared to estimated
payments in CY 2017. The overall
impact of the CY 2018 changes is
projected to be a 0.8 percent increase in
payments. Hospital-based ESRD
facilities have an estimated 1.0 percent
increase in payments compared with
freestanding facilities with an estimated
0.8 percent increase.
We estimate that the aggregate ESRD
PPS expenditures would increase by
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approximately $100 million from CY
2017 to CY 2018. This reflects a $90
million increase from the payment rate
update and a $10 million increase due
to the updates to the outlier threshold
amounts. As a result of the projected 0.8
percent overall payment increase, we
estimate that there would be an increase
in beneficiary co-insurance payments of
0.8 percent in CY 2018, which translates
to approximately $20 million.
2. Impacts of the Proposed Payment for
Renal Dialysis Services Furnished to
Individuals With AKI
We anticipate an estimated $2.0
million would be paid to ESRD facilities
in CY 2018 as a result of AKI patients
receiving renal dialysis services in the
ESRD facility at the ESRD PPS base rate
versus receiving those services in the
hospital outpatient setting.
3. Impacts of the Proposed ESRD QIP
We estimate that the overall economic
impact of the ESRD QIP would be
approximately $113 million in PY 2020
and $113 million in PY 2021. The $113
million figure for PY 2020 includes
costs associated with the collection of
information requirements, which we
estimate would be approximately $91
million.1 For PY 2021, we estimate that
ESRD facilities would experience an
aggregate impact of approximately $120
million as a result of the PY 2021 ESRD
QIP. For PY 2021, these estimates have
not significantly changed because we
are not proposing to add any new
measures to the program which would
require an increased burden associated
with the collection of information
requirements. We are proposing to
replace two existing measures but no
new burdens are being proposed.
Similarly, we are not proposing to
increase the size of either of the Data
Validation Studies proposed for PY
2020 so facilities would not experience
an increase in burden with respect to
being selected to participate in either of
those two studies. Therefore, the overall
economic impact of the ESRD QIP
would be similar in PY 2021 to what it
was in PY 2020.
The ESRD QIP would continue to
incentivize facilities to provide highquality care to beneficiaries.
1 We note that the aggregate impact of the PY
2020 ESRD QIP was included in the CY 2017 ESRD
PPS Final Rule (81 FR 77957). The previously
finalized aggregate impact of $113 million reflects
the PY 2020 estimated payment reductions and the
collection of information requirements finalized in
the PY 2020 ESRD QIP Final Rule.
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II. Calendar Year (CY) 2018 End-Stage
Renal Disease (ESRD) Prospective
Payment System (PPS)
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A. Background
1. Statutory Background
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 with 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.
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 ESRDrelated 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. And 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.
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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 CYs
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 oralonly 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, pertreatment 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 42 CFR
413.171, which is in subpart H of 42
CFR part 413. Our other payment
policies are also included in regulations
in subpart H of 42 CFR part 413. 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, four
co-morbidity categories, and pediatric
patient-level adjusters consisting of two
age categories and two dialysis
modalities (42 CFR 413.235(a) and (b)).
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The ESRD PPS provides for three
facility-level adjustments. The first
payment adjustment accounts for ESRD
facilities furnishing a low volume of
dialysis treatments (42 CFR 413.232).
The second adjustment reflects
differences in area wage levels
developed from Core Based Statistical
Areas (CBSAs) (42 CFR 413.231). The
third payment adjustment accounts for
ESRD facilities furnishing renal dialysis
services in a rural area (42 CFR
413.233).
The ESRD PPS allows for a training
add-on for home and self-dialysis
modalities (42 CFR 413.235(c)) and an
additional payment for high cost
outliers due to unusual variations in the
type or amount of medically necessary
care when applicable (42 CFR 413.237).
The ESRD PPS also provides for a
transitional drug add-on payment
adjustment (TDAPA) to pay for a new
injectable or intravenous product that is
not considered included in the ESRD
PPS base rate, meaning a product that is
used to treat or manage a condition for
which there is not an existing ESRD PPS
functional category (42 CFR 413.234).
The ESRD PPS functional categories
represent distinct groupings of drugs or
biologicals, as determined by CMS,
whose end action effect is the treatment
or management of a condition or
conditions associated with ESRD. New
injectable or intravenous products that
are not included in a functional category
in the ESRD PPS base rate are paid for
using the TDAPA for a minimum of 2
years, until sufficient claims data for
rate setting analysis is available. At that
point, utilization would be reviewed
and the ESRD PPS base rate modified,
if appropriate, to account for these
products. The TDAPA is based on
pricing methodologies under section
1847A of the Act (42 CFR 413.234(c)).
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 4year transition period. Since the
implementation of the ESRD PPS, we
have published annual rules to make
routine updates, policy changes, and
clarifications.
On November 4, 2016, we published
in the Federal Register a final rule (81
FR 77384 through 77969) entitled,
‘‘Medicare Program; End-Stage Renal
Disease Prospective Payment System,
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Coverage and Payment for Renal
Dialysis Services Furnished to
Individuals With Acute Kidney Injury,
End-Stage Renal Disease Quality
Incentive Program, Durable Medical
Equipment, Prosthetics, Orthotics and
Supplies Competitive Bidding Program
Bid Surety Bonds, State Licensure and
Appeals Process for Breach of Contract
Actions, Durable Medical Equipment,
Prosthetics, Orthotics and Supplies
Competitive Bidding Program and Fee
Schedule Adjustments, Access to Care
Issues for Durable Medical Equipment;
and the Comprehensive End-Stage Renal
Disease Care Model; Final Rule’’
(hereinafter referred to as the CY 2017
ESRD PPS final rule). In that rule, we
updated the ESRD PPS base rate for CY
2017, the wage index and wage index
floor, the outlier policy, and the home
and self-dialysis training add-on
payment adjustment. For further
detailed information regarding these
updates, see 81 FR 77384.
B. Provisions of the Proposed Rule
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1. Pricing Eligible Outlier Drugs and
Biologicals That Were or Would Have
Been, Prior to January 1, 2011,
Separately Billable Under Medicare Part
B
a. Summary of Outlier Calculation
Our regulations at 42 CFR 413.237
specify the methodology used to
calculate outlier payments. Under the
ESRD PPS outlier policy, an ESRD
facility is eligible for an outlier payment
when the facility’s per treatment
imputed MAP amount for ESRD outlier
services furnished to a beneficiary
exceeds the predicted ESRD outlier
services MAP amount for outlier
services plus the FDL amount, as
specified in § 413.237(b). In the CY 2011
ESRD PPS final rule (75 FR 49134
through 49147), we discuss the details
of establishing the outlier policy under
the ESRD PPS, including determining
eligibility for outlier payments. We
discuss the proposed CY 2018 updates
to the outlier policy in section II.B.2.c
of this proposed rule.
Under 42 CFR 413.237(a)(1), ESRD
outlier services include (1) certain items
and services included in the ESRD PPS
bundle that were or would have been
separately billable under Medicare Part
B prior to the implementation of the
ESRD PPS, including ESRD-related
drugs and biologicals, ESRD-related
laboratory tests, and other ESRD-related
medical/surgical supplies; and (2)
certain renal dialysis service drugs
included in the ESRD PPS bundle that
were covered under Medicare Part D
prior to the implementation of the ESRD
PPS. For CMS to calculate outlier
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eligibility and payments, ESRD facilities
must identify on the monthly claim
which outlier services have been
furnished. CMS provides a list of outlier
services on the CMS Web site, https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/ESRDpayment/
Outlier_Services.html, which is subject
to certain additions and exclusions as
discussed in the CY 2012 ESRD PPS
final rule (76 FR 70246) and Chapter 8
Section 20.1 of CMS Publication 100–04
(https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/
downloads/clm104c08.pdf).
It is important for ESRD facilities to
report the outlier services on the claim
because imputed outlier service MAP
amounts for a beneficiary are based on
the actual utilization of outlier services.
Specifically, we estimate an ESRD
facility’s imputed costs for ESRD outlier
services based on available pricing data.
In the CY 2011 ESRD PPS final rule we
finalized the pricing data that we use to
estimate imputed outlier services MAP
amounts for the different categories of
outlier services (75 FR 49141). With
regard to Part B ESRD-related drugs and
biologicals that were separately billable
prior to implementation of the ESRD
PPS, we finalized a policy to base the
prices for these items on the most
current Average Sales Price (ASP) data
plus 6 percent. Our rationale for this
decision was that ASP data for ESRDrelated drugs and biologicals is updated
quarterly and was the basis for payment
of these drugs and biologicals prior to
the implementation of the ESRD PPS.
b. Use of ASP Methodology Under the
ESRD PPS
Since the implementation of the ESRD
PPS, we have referred to the use of the
ASP methodology when we needed to
price ESRD-related drugs and
biologicals previously paid separately
under Part B (prior to the ESRD PPS) for
purposes of ESRD PPS policies or
calculations. For example, as discussed
above, in the CY 2011 ESRD PPS final
rule, we finalized the use of the ASP
plus 6 percent methodology for pricing
Part B ESRD-related drugs and
biologicals under the outlier policy (75
FR 49141). In the CY 2012 ESRD PPS
final rule (76 FR 20244), we stated that
under the outlier policy, we use the ASP
methodology.
In the CY 2013 ESRD PPS final rule
(77 FR 67463), we finalized that for CY
2013 and subsequent years we will
continue to use the ASP methodology,
including any modifications finalized in
the Physician Fee Schedule (PFS) final
rules, to compute outlier MAP amounts.
(We referred to the PFS since this is
typically the rulemaking vehicle CMS
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31195
uses for provisions related to covered
Part B drugs and biologicals, however,
we note that other vehicles such as
standalone rules, are used as well.) In
the CY 2013 ESRD PPS final rule, we
also finalized the use of the ASP
methodology for any other policy that
requires the use of payment amounts for
drugs and biologicals that, absent the
ESRD PPS, would be paid separately.
In accordance with this policy, in the
CY 2016 ESRD PPS proposed rule (80
FR 37829 through 37833), we proposed
to use ASP methodology for purposes of
two policies under the ESRD PPS drug
designation process. Specifically, we
proposed that any new injectable or
intravenous product that fits into one of
the ESRD functional categories would
be considered included in the ESRD
PPS and would count toward the
calculation of an outlier payment. We
further explained that in calculating the
outlier payment, we price drugs using
the ASP methodology, which is
currently ASP + 6 percent (80 FR
37831). In addition, we proposed that
for a new injectable or intravenous
product that is used to treat or manage
a condition for which there is not an
ESRD PPS functional category, the new
injectable or intravenous product would
be eligible for the TDAPA if it meets
specific criteria (80 FR 37831 through
37832). We further proposed that we
would base the TDAPA on the ASP
methodology and pay this amount
during the utilization data collection
time period (80 FR 37832 through
37833).
As we discussed in the CY 2016 ESRD
PPS final rule (80 FR 69023 through
69024), commenters expressed concern
regarding the availability of ASP data
when including new injectable or
intravenous products into the ESRD PPS
bundled payment, for purposes of both
the outlier calculation and TDAPA. A
commenter pointed out that under the
proposal, new products would qualify
as outlier services, and if we fail to
allow separate payment at launch, there
would be no ASP upon which to base
an outlier payment. That commenter
recommended that we consider how to
avoid jeopardizing beneficiary access by
implementing an outlier payment based
on wholesale acquisition cost (WAC) or
another readily available price. We
agreed with the commenter, and stated
that in the event we do not establish an
ASP, WAC could be used. We explained
that we consider WAC pricing to be a
part of the pricing methodologies
specified in section 1847A of the Act,
and we would use the methodologies
available to us under that authority in
order to accurately determine a price for
the calculation of outlier payments for
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new injectable and intravenous drugs
that fit into one of the existing ESRD
PPS functional categories. However, we
did not address extending this policy to
Part B ESRD-related drugs and
biologicals that are currently eligible for
outlier consideration that may not have
ASP data.
Also, in the CY 2016 ESRD PPS final
rule (80 FR 69024), other commenters
expressed concern regarding the use of
ASP data for purposes of the TDAPA.
The commenters suggested that ASP
would not be truly reflective of the
actual cost of the drugs. One commenter
pointed out that there is often a data lag
between ASP and the actual cost of the
drugs and as a result, the TDAPA may
not reflect the actual cost of the drug.
We responded that the ASP
methodology is a part of the pricing
methodologies specified in section
1847A of the Act, which may also
include WAC pricing during the first
quarter of sales as specified in section
1847A(c)(4) of the Act. We agreed with
commenters that ASP pricing may not
always be the most appropriate way to
calculate the TDAPA. Therefore, we
revised the regulation text at
§ 413.234(c)(1) to refer to the pricing
methodologies under section 1847A of
the Act, rather than ASP pricing
methodology, because these
methodologies include ASP, as well as
WAC.
c. Pricing Methodologies Under Section
1847A of the Act
Medicare Part B follows the
provisions under section 1847A of the
Act for purposes of determining the
payment amounts for drugs and
biologicals that are described in section
1842(o)(1)(C) of the Act and that are
furnished on or after January 1, 2005.
While most Part B drugs (excluding
those paid on a cost or prospective
payment basis) are paid at ASP plus 6
percent, there are cases where ASP is
unavailable. For example, when a new
drug or biological is brought to market,
sales data is not sufficiently available
for the manufacturer to compute an
ASP. In these cases, the payment
amount for these drugs could be
determined using WAC (as specified in
section 1847A(c)(4) of the Act) or, when
WAC is not available, the Medicare
Administrative Contractor has
discretion in determining the payment
amount. Under section 1847A(d) of the
Act, CMS also has the authority to
substitute an Average Manufacturer
Price (AMP) or Widely Available Market
Price (WAMP)-based payment amount
for the ASP-based payment amount
when the ASP exceeds the AMP or
WAMP by a threshold amount. As
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discussed in the CY 2013 PFS final rule
(77 FR 69140 through 69141), the AMP
price substitution policy is not utilized
frequently and WAMP-based price
substitutions are not currently
implemented. CMS also uses a carryover
pricing policy in the very rare situations
when a manufacturer’s ASP data for a
multiple source drug product is missing,
as discussed in the CY 2011 PFS final
rule (75 FR 73461 through 73462).
d. Proposal for Pricing Eligible Outlier
Drugs and Biologicals That Were or
Would Have Been, Prior to January 1,
2011, Separately Billable Under
Medicare Part B
As we have described above, section
1847A of the Act provides methods that
are used to determine payment amounts
for most separately paid Part B drugs,
that is, drugs and biologicals that are not
paid on a cost or PPS basis (see section
1842(o)(1) of the Act). We are aware of
several circumstances in which an ASPbased payment amount is not available.
For example, an ASP-based payment
amount is not available when there is no
longer a Medicare program need for a
drug to remain on the ASP fee schedule,
or when drugs or biologicals are new to
market and manufacturers have not yet
reported ASP data. However, based on
CMS’ experience with determining Part
B drug payment limits under section
1847A of the Act, we believe there are
limited situations in which ASP data
would not be available for drugs or
biologicals that could qualify for the
outlier calculation. Nevertheless, we
believe that these drugs and biologicals,
when they are determined to be an
ESRD outlier service, should count
toward the outlier calculation.
In this proposed rule, we propose to
extend the use of all pricing
methodologies under section 1847A of
the Act for purposes of the ESRD PPS
outlier policy, specifically for current
ESRD-related drugs and biologicals that
were or would have been separately
billable under Part B prior to the
implementation of the ESRD PPS and
are outlier eligible for CY 2018 and
subsequent years. As explained above,
we have already established a policy
under the drug designation process in
the CY 2016 ESRD PPS final rule (80 FR
69023) whereby we use the pricing
methodologies specified in section
1847A of the Act to determine the
TDAPA for a new injectable or
intravenous product that is not
considered included in the ESRD PPS
base rate (42 CFR 413.234(c)). In
addition, we have established that we
use these methodologies to determine a
price for the calculation of outlier
payments for new injectable and
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intravenous drugs that fit into one of the
existing the functional categories (80 FR
69023).
We believe that using the pricing
methodologies under section 1847A of
the Act is consistent with the ESRD PPS
drug designation process and how
covered drugs and biologicals are paid
under Medicare Part B. We believe that
consistency with Medicare Part B
payment for drugs and biologicals
would be beneficial to ESRD facilities
because this is the way CMS pays for
injectable drugs and biologicals on the
ESRD claim with the AY modifier; and
therefore facilities would be able to
predict outlier payments. We are
proposing to apply any pricing
methodology available under section
1847A of the Act as appropriate when
ASP pricing is unavailable for eligible
drugs and biologicals under the outlier
policy that were or would have been
separately billable under Part B prior to
the implementation of the ESRD PPS. In
situations where ASP data is not
available and other methodologies
under section 1847A of the Act do not
apply (including but not limited to AMP
price substitution or carryover pricing),
we believe that a WAC-based payment
amount can be determined instead.
Based on our experience with
determining Part B drug payments
under section 1847A of the Act, we
believe that drugs and biologicals that
are approved by the Food and Drug
Administration and are being sold in the
United States nearly always have WAC
amounts published in pricing
compendia. We believe this proposal is
consistent with the intent of the ESRD
PPS outlier policy, which is to provide
a payment adjustment for high cost
patients due to unusual variations in the
type or amount of medically necessary
care. If there are drugs and biologicals
that ESRD facilities furnish for the
treatment of ESRD that qualify as ESRD
outlier services and do not have ASP
data, we would want these items
counted toward an outlier payment
since they are a part of the cost the
facility is incurring. When a drug or
biological does not have ASP data or
WAC data or cannot otherwise be priced
under section 1847A of the Act, we
propose that it would not count toward
the outlier calculation. When the
utilization of a drug or biological is not
counted toward the outlier calculation,
it may result in a lower outlier payment
or no outlier payment to the ESRD
facility.
We are soliciting comment on our
proposal to use any pricing
methodology available under section
1847A of the Act for purposes of the
ESRD PPS outlier policy. We are also
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soliciting comment on our proposal that
when pricing methodologies are not
available under section 1847A of the
Act, the drug or biological would not
count toward the outlier calculation.
2. Proposed CY 2018 ESRD PPS Update
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a. ESRD Bundled Market Basket
i. Proposed CY 2018 ESRD Market
Basket Update, Productivity
Adjustment, and Labor-Related Share
for ESRD PPS
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 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.
Section 1881(b)(14)(F)(i)(I) of the Act,
as added by section 217(b)(2)(A) of
PAMA, provides that in order to
accomplish the purposes of
subparagraph (I) with respect to 2016,
2017, and 2018, after determining the
market basket percentage increase factor
for each of 2016, 2017, and 2018, the
Secretary shall reduce such increase
factor by 1.25 percentage points for each
of 2016 and 2017 and by 1.0 percentage
point for 2018. Accordingly, for CY
2018, we will reduce the proposed
amount of the market basket percentage
increase factor by 1.0 percent as
required by section 1881(b)(14)(F)(i)(I)
of the Act, and will further reduce it by
the productivity adjustment.
As required under section
1881(b)(14)(F)(i) of the Act, CMS
developed an all-inclusive ESRDB input
price index (75 FR 49151 through
49162) and subsequently revised and
rebased the ESRDB input price index in
the CY 2015 ESRD PPS final rule (79 FR
66129 through 66136). 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
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document, refers to the ESRDB input
price index.
We propose to use the CY 2012-based
ESRDB market basket as finalized and
described in the CY 2015 ESRD PPS
final rule (79 FR 66129 through 66136)
to compute the CY 2018 ESRDB market
basket increase factor and labor-related
share based on the best available data.
Consistent with historical practice, we
estimate the ESRDB market basket
update based on IHS Global Inc.’s (IGI),
forecast using the most recently
available data. IGI is a nationally
recognized economic and financial
forecasting firm that contracts with CMS
to forecast the components of the market
baskets.
Using this methodology and the IGI
forecast for the first quarter of 2017 of
the CY 2012-based ESRDB market
basket (with historical data through the
fourth quarter of 2016), and consistent
with our historical practice of
estimating market basket increases
based on the best available data, the
proposed CY 2018 ESRDB market basket
increase factor is 2.2 percent. As
required by section 1881(b)(14)(F)(I)(i)
of the Act as amended by section
217(b)(2) of PAMA, we must reduce the
amount of the market basket increase
factor by 1.0 percent, resulting in a
proposed CY 2018 ESRDB market basket
percentage increase factor of 1.2
percent.
Under section 1881(b)(14)(F)(i) of the
Act, as amended by section 3401(h) of
the Affordable Care 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
multifactor productivity (MFP) is
derived by subtracting the contribution
of labor and capital input growth from
output growth. The detailed
methodology for deriving the MFP
projection was finalized 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 Web site at https://
www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-andReports/MedicareProgramRatesStats/
MarketBasketResearch.html.
Using IGI’s first quarter 2017 forecast,
the MFP adjustment for CY 2018 (the
10-year moving average of MFP for the
period ending CY 2018) is projected to
be 0.5 percent.
For the CY 2018 ESRD payment
update, we propose to continue using a
labor-related share of 50.673 percent for
the ESRD PPS payment, which was
finalized in the CY 2015 ESRD PPS final
rule (79 FR 66136).
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ii. Proposed CY 2018 ESRDB Market
Basket Update, Adjusted for Multifactor
Productivity (MFP)
Under section 1881(b)(14)(F) of the
Act, beginning in CY 2012, ESRD PPS
payment amounts shall be annually
increased by an ESRD market basket
percentage increase factor reduced by
the productivity adjustment. For CY
2018, section 1881(b)(14)(F)(i)(I) of the
Act, as amended by section
217(b)(2)(A)(ii) of PAMA, requires the
Secretary to implement a 1.0 percentage
point reduction to the ESRDB market
basket increase factor in addition to the
productivity adjustment.
As a result of these provisions, the
proposed CY 2018 ESRD market basket
increase is 0.7 percent. This market
basket increase is calculated by starting
with the proposed CY 2018 ESRDB
market basket percentage increase factor
of 2.2 percent, reducing it by the
mandated legislative adjustment of 1.0
percent (required by section
1881(b)(14)(F)(i)(I) of the Act), and
reducing it further by the MFP
adjustment (the 10-year moving average
of MFP for the period ending CY 2018)
of 0.5 percent. As is our general
practice, if more recent data are
subsequently available (for example, a
more recent estimate of the market
basket or MFP adjustment), we will use
such data to determine the CY 2018
market basket update and MFP
adjustment in the CY 2018 ESRD PPS
final rule.
b. The Proposed CY 2018 ESRD PPS
Wage Indices
i. Annual Update of the Wage Index
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 49117), we
finalized the use of the Office of
Management and Budget’s (OMB’s)
CBSAs-based geographic area
designations to define urban and rural
areas and their corresponding wage
index values. OMB publishes bulletins
regarding CBSA changes, including
changes to CBSA numbers and titles.
The latest bulletin, as well as
subsequent bulletins, is available online
at https://www.whitehouse.gov/omb/
information-for-agencies/bulletins.
For CY 2018, we would continue to
use the same methodology as finalized
in the CY 2011 ESRD PPS final rule (75
FR 49117) for determining the wage
indices for ESRD facilities. Specifically,
we would update the wage indices for
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CY 2018 to account for updated wage
levels in areas in which ESRD facilities
are located. We use the most recent prefloor, pre-reclassified hospital wage data
collected annually under the inpatient
prospective payment system. 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 pre-floor hospital data
that are unadjusted for occupational
mix. The proposed CY 2018 wage index
values for urban areas are listed in
Addendum A (Wage Indices for Urban
Areas) and the proposed CY 2018 wage
index values for rural areas are listed in
Addendum B (Wage Indices for Rural
Areas). Addenda A and B are located on
the CMS Web site at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/ESRDpayment/
End-Stage-Renal-Disease-ESRDPayment-Regulations-and-Notices.html.
In the CY 2011 and CY 2012 ESRD
PPS final rules (75 FR 49116 through
49117 and 76 FR 70239 through 70241,
respectively), we also discussed and
finalized the methodologies we use to
calculate wage index values for ESRD
facilities that are located in urban and
rural areas where there is no hospital
data. For urban areas with no hospital
data, we compute the average wage
index value of all urban areas within the
State and 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 wage index for Guam as
established in the CY 2014 ESRD PPS
final rule (78 FR 72172) (0.9611) to
American Samoa and the Northern
Mariana Islands. We apply the statewide
urban average based on the average of
all urban areas within the state (78 FR
72173) (0.8478) to Hinesville-Fort
Stewart, Georgia. We note that if
hospital data becomes available for
these areas, we will use that data for the
appropriate CBSAs instead of the proxy.
A wage index floor value has been
used instead of the calculated wage
index values below the floor in making
payment for renal dialysis services
under the ESRD PPS. 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.
In the CY 2011 ESRD PPS final rule
(75 FR 49116 through 49117), we
finalized that we would continue to
reduce the wage index floor by 0.05 for
each of the remaining years of the ESRD
PPS transition, that is, until CY 2014. In
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the CY 2012 ESRD PPS final rule (76 FR
70241), we finalized the 0.05 reduction
to the wage index floor for CYs 2012
and 2013, resulting in a wage index
floor of 0.5500 and 0.5000, respectively.
We continued to apply and to reduce
the wage index floor by 0.05 in the CY
2013 ESRD PPS final rule (77 FR 67459
through 67461). Although our intention
initially was to provide a wage index
floor only through the 4-year transition
to 100 percent implementation of the
ESRD PPS (75 FR 49116 through 49117;
76 FR 70240 through 70241), in the CY
2014 ESRD PPS final rule (78 FR 72173),
we continued to apply the wage index
floor and continued to reduce the floor
by 0.05 per year for CY 2014 and for CY
2015.
In the CY 2016 ESRD PPS final rule
(80 FR 69006 through 69008), we
finalized the continuation of the
application of the wage index floor of
0.4000 to areas with wage index values
below the floor, rather than reducing the
floor by 0.05. We stated in that rule that
we needed more time to study the wage
indices that are reported for Puerto Rico
to assess the appropriateness of
discontinuing the wage index floor.
Also, in that rule a commenter provided
three alternative wage indices for Puerto
Rico for the CY 2016 ESRD PPS final
rule: (1) Utilize our policy for areas that
do not have reliable hospital data by
applying the wage index for Guam as we
did in implementing the ESRD PPS in
the Northern Marianas and American
Samoa; (2) use the U.S. Virgin Islands as
a proxy for Puerto Rico, given the
geographic proximity and its ‘‘nonmainland’’ or ‘‘island’’ nature; or (3)
reestablish the wage index floor in effect
in 2010 when Puerto Rico became the
only location with wage areas subject to
the floor, that is, 0.65.
In the CY 2017 proposed rule (81 FR
42817), we presented the findings from
analyses of ESRD facility cost report and
claims data submitted by facilities
located in Puerto Rico and mainland
facilities. We solicited public comments
on the wage index for CBSAs in Puerto
Rico as part of our continuing effort to
determine an appropriate course of
action. We did not propose to change
the wage index floor for CBSAs in
Puerto Rico, but we requested public
comments in which stakeholders can
provide useful input for consideration
in future decision-making. Specifically,
we solicited comment on the useful
suggestions that were submitted in the
CY 2016 ESRD PPS final rule (80 FR
69007). After considering the public
comments we received regarding the
wage index floor, we finalized the wage
index floor of 0.4000 in the CY 2017
ESRD PPS final rule (81 FR 77858).
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In this proposed rule, for CY 2018 and
subsequent years, we are proposing to
maintain the current wage index floor of
0.4000 for CBSAs that have wage values
that fall below the floor. The cost report
analyses we have conducted over the
past several years are inconclusive and
have not convinced us that an increase
in the wage index floor is warranted at
this time.
We continue to believe maintaining
the current wage index floor value of
0.4000 is appropriate as it continues to
provide additional payment support to
the lowest wage areas and avoids the
need for an additional budget-neutrality
adjustment that would reduce the ESRD
PPS base rate, beyond the adjustment
needed to reflect updated hospital wage
data, in order to maintain budget
neutrality for wage index updates. We
will continue to monitor and analyze
ESRD facility cost reports and projected
impacts to guide future rulemaking with
regard to the wage index floor.
ii. Application of the Wage Index Under
the ESRD PPS
A facility’s wage index is applied to
the labor-related share of the ESRD PPS
base rate. In the CY 2015 ESRD PPS
final rule (79 FR 66136), we finalized
the labor-related share of 50.673
percent, which is based on the 2012based ESRDB market basket. Thus, for
CY 2018, the labor-related share to
which a facility’s wage index would be
applied is 50.673 percent.
c. CY 2018 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 cancer. The
ESRD PPS recognizes high cost patients,
and we have codified the outlier policy
in our regulations at 42 CFR 413.237.
The policy provides the following ESRD
outlier items and services are included
in the ESRD PPS bundle: (1) ESRDrelated drugs and biologicals that were
or would have been, prior to January 1,
2011, separately billable under
Medicare Part B; (2) ESRD-related
laboratory tests that were or would have
been, prior to January 1, 2011,
separately billable under Medicare Part
B; (3) medical/surgical supplies,
including syringes, used to administer
ESRD-related drugs that were or would
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have been, prior to January 1, 2011,
separately billable under Medicare Part
B; and (4) renal dialysis services drugs
that were or would have been, prior to
January 1, 2011, covered under
Medicare Part D, including ESRDrelated oral-only drugs effective January
1, 2025.
In the CY 2011 ESRD PPS final rule
(75 FR 49142), we 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
originally specified in Attachment 3 of
Change Request 7064, Transmittal 2033
issued August 20, 2010, 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 was issued to correct the
subject on the Transmittal page and
made no other changes.
Furthermore, we use administrative
issuances and guidance to continually
update the renal dialysis service items
available for outlier payment via our
quarterly update CMS Change Requests,
when applicable. We use this separate
guidance to identify renal dialysis
service drugs that were or would have
been covered under Medicare Part D for
outlier eligibility purposes and in order
to provide unit prices for calculating
imputed outlier services. In addition,
we also identify through our monitoring
efforts items and services that are either
incorrectly being identified as eligible
outlier services or any new items and
services that may require an update to
the list of renal dialysis items and
services that qualify as outlier services,
which are made through administrative
issuances.
Our regulations at 42 CFR 413.237
specify the methodology used to
calculate outlier payments. An ESRD
facility is eligible for an outlier payment
if its actual or imputed 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) plus the
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fixed-dollar loss (FDL) amount. In
accordance with § 413.237(c) of our
regulations, 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,
using 2007 data, we established the
outlier percentage 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 to compute the
payment adjustments.
For the CY 2018 outlier policy, we
would use the existing methodology for
determining outlier payments by
applying outlier services payment
multipliers that were developed for the
CY 2016 ESRD PPS final rule (80 FR
68993–68994, 69002). We used these
outlier services payment multipliers to
calculate the predicted outlier service
MAP amounts and projected outlier
payments for CY 2018.
For CY 2018, we propose that the
outlier services MAP amounts and FDL
amounts would be derived from claims
data from CY 2016. 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 2018 would be
based on utilization of renal dialysis
items and services furnished under the
ESRD PPS in CY 2016. 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.
In the CY 2017 ESRD PPS final rule
(81 FR 77860), we stated that based on
the CY 2015 claims data, outlier
payments represented approximately
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0.93 percent of total payments. For this
proposed rule, as discussed below, CY
2016 claims data show outlier payments
represented approximately 0.78 percent
of total payments. We believe that
trends in the utilization of the ESAs
could be a reason for the decrease.
Beginning in 2015 and continuing into
2016, there were large shifts in the
composition of the utilization of ESA
drugs. Specifically, utilization of
Epoetin (EPO) alfa decreased and
utilization of the longer-acting ESA
drugs, darbepoetin and EPO beta,
increased, based on estimates of average
ESA utilization per session. As EPO alfa
is measured in different units than both
darbepoetin and EPO beta, it is difficult
to compare the overall utilization of
ESAs between 2014 and 2016 by units
alone.
In examining the claims data, we find
that compositional shift away from use
of EPO alfa to the longer acting
darbepoetin and EPO beta was a
significant factor in the decrease in total
ESA costs in 2016. We first calculated
the actual cost for ESAs administered
during 2016. We then calculated the
projected cost of ESAs that was used for
the CY 2016 ESRD PPS final rule, using
total utilization from 2014 and drug
prices from 2015 Q3 inflated to 2016
prices. The actual costs of ESAs
administered in 2016 were roughly 20
percent lower than the value projected
in the CY 2016 ESRD PPS final rule. We
then calculated the projected cost of
ESAs assuming that the utilization of
various ESAs per dialysis session in
2014 and 2016 were similar and also
used the prices and total dialysis
session count from 2016. The projected
costs from these two scenarios were
similar and suggest that compositional
change in ESA utilization was likely a
significant factor in the decrease in the
total cost of ESAs between 2014 and
2016. We continue to believe that the
decline is leveling off and that 1.0
percent is an appropriate threshold for
outlier payments.
i. CY 2018 Update to the Outlier
Services MAP Amounts and FDL
Amounts
For CY 2018, we are not proposing
any change to the methodology used to
compute the MAP or FDL amounts.
Rather, we will continue to update the
outlier services MAP amounts and FDL
amounts to reflect the utilization of
outlier services reported on 2016 claims.
For this proposed rule, the outlier
services MAP amounts and FDL
amounts were updated using 2016
claims data. The impact of this update
is shown in Table 1, which compares
the outlier services MAP amounts and
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FDL amounts used for the outlier policy
in CY 2017 with the updated proposed
estimates for this rule. The estimates for
the proposed CY 2018 outlier policy,
which are included in Column II of
Table 1, were inflation adjusted to
reflect projected 2018 prices for outlier
services.
TABLE 1—OUTLIER POLICY: IMPACT OF USING UPDATED DATA TO DEFINE THE OUTLIER POLICY
Column I
Final outlier policy for CY 2017
(based on 2015 data, price
inflated to 2017) *
Column II
Proposed outlier policy for CY
2018
(based on 2016 data, price
inflated to 2018)
Age <18
Average outlier services MAP amount per treatment .....................................
Adjustments .....................................................................................................
Standardization for outlier services .................................................................
MIPPA reduction ..............................................................................................
Adjusted average outlier services MAP amount .............................................
Fixed-dollar loss amount that is added to the predicted MAP to determine
the outlier threshold .....................................................................................
Patient-months qualifying for outlier payment .................................................
Age >=18
Age <18
Age >=18
$38.77
........................
1.0078
0.98
$38.29
$47.00
........................
0.9770
0.98
$45.00
$38.20
........................
1.0218
0.98
$38.25
$44.52
........................
0.9788
0.98
$42.70
$68.49
4.6%
$82.92
6.7%
$49.55
7.4%
$83.12
6.3%
* Note that Column I was obtained from Column II of Table 1 from the CY 2017 ESRD PPS final rule.
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As demonstrated in Table 1, the
estimated FDL amount per treatment
that determines the CY 2018 outlier
threshold amount for adults (Column II;
$83.12) is higher than that used for the
CY 2017 outlier policy (Column I;
$82.92). The higher threshold is
accompanied by a decrease in the
adjusted average MAP for outlier
services from $45.00 to $42.70. For
pediatric patients, there is a decrease in
the FDL amount from $68.49 to $49.55.
There is a slight decrease in the adjusted
average MAP for outlier services among
pediatric patients, from $38.29 to
$38.25.
We estimate that the percentage of
patient months qualifying for outlier
payments in CY 2018 will be 6.3 percent
for adult patients and 7.4 percent for
pediatric patients, based on the 2016
claims data. The pediatric 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).
ii. Outlier Percentage
In the CY 2011 ESRD PPS final rule
(75 FR 49081), under § 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 § 413.237. Based on the
2016 claims, outlier payments
represented approximately 0.78 percent
of total payments, slightly below the 1
percent target due to small overall
declines in the use of outlier services.
Recalibration of the thresholds using
2016 data is expected to result in
aggregate outlier payments close to the
1 percent target in CY 2018. We believe
the update to the outlier MAP and FDL
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amounts for CY 2018 would increase
payments for ESRD beneficiaries
requiring higher resource utilization and
move us closer to meeting our 1 percent
outlier policy. 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, but would increase
payments to ESRD facilities for
beneficiaries with renal dialysis items
and services that are eligible for outlier
payments. Therefore, beneficiary coinsurance obligations would also
increase for renal dialysis services
eligible for outlier payments.
d. Proposed Impacts to the CY 2018
ESRD PPS Base Rate
i. ESRD PPS Base Rate
In the CY 2011 ESRD PPS final rule
(75 FR 49071 through 49083), we
discussed the development of the ESRD
PPS per treatment base rate that is
codified in the Medicare regulations at
§ 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
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1881(b)(14)(D) of the Act and
regulations at § 413.230, the ESRD PPS
base rate is adjusted for the patient
specific case-mix adjustments,
applicable facility adjustments,
geographic differences in area wage
levels using an area wage index, as well
as applicable outlier payments, training
add-on payments, or transitional drug
add-on payments.
ii. Annual Payment Rate Update for CY
2018
We are proposing an ESRD PPS base
rate for CY 2018 of $233.31. This update
reflects several factors, described in
more detail as follows:
• 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 2018 projection for the ESRDB
market basket is 2.2 percent. In CY
2018, this amount must be reduced by
1.0 percentage point as required by
section 1881(b)(14)(F)(i)(I) of the Act, as
amended by section 217(b)(2)(A) of
PAMA, which is calculated as 2.2¥1.0
= 1.2 percent. This amount is then
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. The
proposed MFP adjustment for CY 2018
is 0.5 percent, thus yielding a proposed
update to the base rate of 0.7 percent for
CY 2018 (1.2¥0.5 = 0.7 percent).
Therefore, the proposed ESRD PPS base
rate for CY 2018 before application of
the wage index budget-neutrality
adjustment factor would be $233.17
($231.55 × 1.007 = $233.17).
• Wage Index Budget-Neutrality
Adjustment Factor: We compute a wage
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index budget-neutrality adjustment
factor that is applied to the ESRD PPS
base rate. For CY 2018, 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). The CY 2018 proposed wage
index budget-neutrality adjustment
factor is 1.000605. This application
would yield a CY 2018 ESRD PPS
proposed base rate of $233.31 ($233.17
× 1.000605 = $233.31).
In summary, we are proposing a CY
2018 ESRD PPS base rate of $233.31.
This amount reflects a market basket
increase of 0.7 percent and the CY 2018
wage index budget-neutrality
adjustment factor of 1.000605.
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III. CY 2018 Payment for Renal Dialysis
Services Furnished to Individuals With
Acute Kidney Injury (AKI)
A. Background
On June 29, 2015, the Trade
Preferences Extension Act of 2015
(TPEA) (Pub. L. 114–27) was enacted. In
the TPEA, the Congress amended the
Act to include coverage and provide for
payment for dialysis furnished by an
ESRD facility to an individual with
acute kidney injury (AKI). Specifically,
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 AKI. Section 808(b) of the TPEA
amended section 1834 of the Act by
adding a new subsection (r) to the Act.
Subsection (r)(1) of section 1834 of the
Act provides for payment, beginning
January 1, 2017, 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, as adjusted by any applicable
geographic adjustment applied under
section 1881(b)(14)(D)(iv)(II) of the Act
and may be adjusted by the Secretary
(on a budget neutral basis for payments
under section 1834(r) of the Act) by any
other adjustment factor under section
1881(b)(14)(D) of the Act.
In the CY 2017 ESRD PPS final rule,
we finalized several coverage and
payment policies in order to implement
subsection (r) of section 1834 of the Act
and the amendments to section
1881(s)(2)(F) of the Act, including the
payment rate for AKI dialysis (81 FR
77866 through 77872). We interpret
section 1834(r)(1) of the Act to mean the
amount of payment for AKI dialysis
services is the base rate for renal
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dialysis services determined for such
year under the ESRD base rate as set
forth in 42 CFR 413.220, updated by the
ESRD bundled market basket percentage
increase factor minus a productivity
adjustment as set forth in
§ 413.196(d)(1), adjusted for wages as set
forth in § 413.231, and adjusted by any
other amounts deemed appropriate by
the Secretary under § 413.373. We
codified this policy in 42 CFR 413.372.
B. Annual Payment Rate Update for CY
2018
1. CY 2018 AKI Dialysis Payment Rate
The payment rate for AKI dialysis is
the ESRD PPS base rate determined for
a year under section 1881(b)(14) of the
Act, which is the finalized ESRD PPS
base rate. We note that ESRD facilities
have the ability to bill Medicare for nonrenal dialysis items and services and
receive separate payment in addition to
the payment rate for AKI dialysis.
As discussed in section II.B.2.d of this
proposed rule, the CY 2018 proposed
ESRD PPS base rate is $233.31, which
reflects the ESRD bundled market basket
and multifactor productivity
adjustment. Accordingly, we are
proposing a CY 2018 per treatment
payment rate of $233.31 for renal
dialysis services furnished by ESRD
facilities to individuals with AKI.
2. Geographic Adjustment Factor
Section 1834(r)(1) of the Act further
provides that the amount of payment for
AKI dialysis services shall be the base
rate for renal dialysis services
determined for a year under section
1881(b)(14) of the Act, as adjusted by
any applicable geographic adjustment
factor applied under section
1881(b)(14)(D)(iv)(II) of the Act. We
interpret the reference to ‘‘any
applicable geographic adjustment factor
applied under subparagraph (D)(iv)(II)
of such section’’ to mean the geographic
adjustment factor that is actually
applied to the ESRD PPS base rate for
a particular facility. Accordingly, we
apply the same wage index that is used
under the ESRD PPS, as discussed in
section II.B.2.d of this proposed rule. In
the CY 2017 ESRD PPS final rule (81 FR
77868), we finalized that the AKI
dialysis payment rate will be adjusted
for wage index for a particular ESRD
facility in the same way that the ESRD
PPS base rate is adjusted for wage index
for that facility. Specifically, we apply
the wage index to the labor-related share
of the ESRD PPS base rate that we
utilize for AKI dialysis to compute the
wage adjusted per-treatment AKI
dialysis payment rate. As stated above,
we are proposing a CY 2018 AKI
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31201
dialysis payment rate of $233.31,
adjusted by the ESRD facility’s wage
index.
IV. End-Stage Renal Disease (ESRD)
Quality Incentive Program (QIP) for
Payment Year (PY) 2021
A. Background
For over 30 years, monitoring the
quality of care provided to end-stage
renal disease (ESRD) patients by dialysis
providers or facilities (hereinafter
referred to collectively as ‘‘facility’’ or
‘‘facilities’’) has been an important
component of the Medicare ESRD
payment system. The ESRD quality
incentive program (QIP) is the most
recent step in fostering improved
patient outcomes by establishing
incentives for dialysis facilities to meet
or exceed performance standards
established by the Centers for Medicare
& Medicaid Services (CMS).
Under the ESRD QIP, payments made
to a dialysis facility by Medicare under
section 1881(b)(14) of the Social
Security Act (the Act) are reduced by up
to 2 percent if the facility does not meet
or exceed the total performance score
with respect to performance standards
established by the Secretary of the
Department of Health and Human
Services (the Secretary) with respect to
certain specified measures.
The calendar year (CY) 2012 ESRD
PPS final rule (76 FR 70228), published
in the Federal Register on November 10,
2011, among other things, set forth
certain requirements for the ESRD QIP
for payment years (PYs) 2013 and 2014.
The CY 2013 ESRD PPS final rule (77
FR 67450), published in the Federal
Register on November 9, 2012, set forth
requirements for the ESRD QIP,
including for payment year 2015 and
beyond. In that rule, CMS added several
new measures to the ESRD QIP’s
measure set and expanded the scope of
some of the existing measures. CMS also
established CY 2013 as the performance
period for the PY 2015 ESRD QIP,
established performance standards and
adopted scoring and payment
methodologies similar to those finalized
for the PY 2014 ESRD QIP.
The CY 2014 ESRD PPS final rule (78
FR 72156), published in the Federal
Register on December 2, 2013, set forth
requirements for the ESRD QIP,
including for PY 2016 and beyond. In
that rule, CMS added several new
measures to the ESRD QIP’s measure
set, established the performance period
for the PY 2016 ESRD QIP, established
performance standards for the PY 2016
measures, and adopted scoring and
payment reduction methodologies that
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were similar to those finalized for the
PY 2015 ESRD QIP.
The CY 2015 ESRD PPS final rule (79
FR 66120), published in the Federal
Register on November 6, 2014, finalized
requirements for the ESRD QIP,
including for PYs 2017 and 2018. In that
rule, CMS finalized the measure set for
both PYs 2017 and 2018, revised the InCenter Hemodialysis Consumer
Assessment of Healthcare Providers
(ICH CAHPS) reporting measure, revised
the Mineral Metabolism Reporting
Measure, finalized an Extraordinary
Circumstances Exemption, and finalized
a new scoring methodology beginning
with PY 2018.
The CY 2016 ESRD PPS final rule (80
FR 68968), published in the Federal
Register on November 6, 2015, set forth
requirements for the ESRD QIP,
including for PYs 2017 through 2019. In
that rule, CMS finalized the PY 2019
Measure Set, reinstated the ICH CAHPS
Attestation beginning with PY 2017, and
revised the Small Facility Adjuster
(SFA) beginning with PY 2017.
The CY 2017 ESRD PPS final rule (81
FR 77834), published in the Federal
Register on November 4, 2016, set forth
new requirements for the ESRD QIP,
including the inclusion of new quality
measures beginning with PYs 2019 and
2020, and updated other policies for the
program.
The ESRD QIP is authorized by
section 1881(h) of the Act, which was
added by section 153(c) of Medicare
Improvements for Patients and
Providers Act of 2008 (MIPPA). Section
1881(h) of the Act requires the Secretary
to establish an ESRD QIP by (1)
selecting measures; (2) establishing the
performance standards that apply to the
individual measures; (3) specifying a
performance period with respect to a
year; (4) developing a methodology for
assessing the total performance of each
facility based on the performance
standards with respect to the measures
for a performance period; and (5)
applying an appropriate payment
reduction to facilities that do not meet
or exceed the established Total
Performance Score (TPS). This proposed
rule discusses each of these elements
and our proposals for their application
to the ESRD QIP.
B. Accounting for Social Risk Factors in
the ESRD QIP Program
We understand that social risk factors
such as income, education, race and
ethnicity, employment, disability,
community resources, and social
support (certain factors of which are
also sometimes referred to as
socioeconomic status factors or sociodemographic status factors), play a
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major role in health. One of our core
objectives is to improve beneficiary
outcomes, including reducing health
disparities, and we want to ensure that
all beneficiaries, including those with
social risk factors, receive high quality
care. In addition, we seek to ensure that
the quality of care furnished by facilities
is assessed as fairly as possible under
our programs while ensuring that
beneficiaries have adequate access to
excellent care.
We have been reviewing reports
prepared by the Office of the Assistant
Secretary for Planning and Evaluation
(ASPE) 2 and the National Academies of
Sciences, Engineering, and Medicine on
the issue of accounting for social risk
factors in CMS’ value-based purchasing
and quality reporting programs, and
considering options on how to address
the issue in these programs. On
December 21, 2016, ASPE submitted a
Report to Congress on a study it was
required to conduct under section 2(d)
of the Improving Medicare Post-Acute
Care Transformation (IMPACT) Act of
2014. The study analyzed the effects of
certain social risk factors in Medicare
beneficiaries on quality measures and
measures of resource use that are used
in one or more of nine Medicare valuebased purchasing programs, including
the ESRD QIP.3 The report also included
considerations for strategies to account
for social risk factors in these programs.
In a January 10, 2017 report released by
The National Academies of Sciences,
Engineering, and Medicine, that body
provided various potential methods for
measuring and accounting for social risk
factors, including stratified public
reporting.4
As noted in the fiscal year (FY) 2017
Inpatient Prospective Payment System/
Long-Term Care Hospital Prospective
Payment System (IPPS/LTCH PPS) final
rule (81 FR 56762 through 57345), the
National Quality Forum (NQF) has
undertaken a 2-year trial period in
which certain new measures, measures
undergoing maintenance review, and
measures endorsed with the condition
2 Office of the Assistant Secretary for Planning
and Evaluation. 2016. Report to Congress: Social
Risk Factors and Performance Under Medicare’s
Value-Based Purchasing Programs. Available at:
https://aspe.hhs.gov/pdf-report/report-congresssocial-risk-factors-and-performance-undermedicares-value-based-purchasing-programs.
3 Office of the Assistant Secretary for Planning
and Evaluation. 2016. Report to Congress: Social
Risk Factors and Performance Under Medicare’s
Value-Based Purchasing Programs. Available at:
https://aspe.hhs.gov/pdf-report/report-congresssocial-risk-factors-and-performance-undermedicares-value-based-purchasing-programs.
4 National Academies of Sciences, Engineering,
and Medicine. 2017. Accounting for social risk
factors in Medicare payment. Washington, DC: The
National Academies Press.
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that they enter the trial period can be
assessed to determine whether risk
adjustment for selected social risk
factors is appropriate for these
measures. This trial entails temporarily
allowing inclusion of social risk factors
in the risk-adjustment approach for
these measures. At the conclusion of the
trial, NQF will issue recommendations
on the future inclusion of social risk
factors in risk adjustment for these
quality measures, and we will closely
review its findings.
As we continue to consider the
analyses and recommendations from
these reports and await the results of the
NQF trial on risk adjustment for quality
measures, we are continuing to work
with stakeholders in this process. As we
have previously communicated, we are
concerned about holding facilities to
different standards for the outcomes of
their patients with social risk factors
because we do not want to mask
potential disparities or minimize
incentives to improve the outcomes for
disadvantaged populations. Keeping
this concern in mind, while we sought
input on this topic previously, we
continue to seek public comment on
whether we should account for social
risk factors in the ESRD QIP, and if so,
what method or combination of
methods would be most appropriate for
accounting for social risk factors.
Examples of methods include: (1)
Adjustment of the payment adjustment
methodology under the ESRD QIP; (2)
adjustment of provider performance
scores (for instance, stratifying facilities
based on the proportion of their patients
who are dual eligible); (3) confidential
reporting of stratified measure rates to
facilities; public reporting of stratified
measure rates; (4) risk adjustment of a
particular measure as appropriate based
on data and evidence; and (5)
redesigning payment incentives (for
instance, rewarding improvement for
facilities caring for patients with social
risk factors or incentivizing facilities to
achieve health equity).
We note that in section V.I.9 of the FY
2018 IPPS proposed rule (82 FR 19796),
we discuss considerations for stratifying
hospitals into peer groups for purposes
of assessing payment adjustments under
the Hospital Readmissions Reduction
Program, as required under the 21st
Century Cures Act of 2016 (Cures Act).
We refer readers to that rule for a
detailed discussion of these alternatives;
while this discussion and corresponding
proposal are specific to the Hospital
Readmissions Reduction Program, they
reflect the level of analysis we would
undertake when evaluating methods
and combinations of methods for
accounting for social risk factors in
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CMS’ other value-based purchasing
programs, such as the ESRD QIP. While
we consider whether and to what extent
we currently have statutory authority to
implement one or more of the abovedescribed methods, we are seeking
comments on whether any of these
methods should be considered, and if
so, which of these methods or
combination of methods would best
account for social risk factors in the
ESRD QIP.
In addition, we are seeking public
comment on which social risk factors
might be most appropriate for stratifying
measure scores and/or potential risk
adjustment of a particular measure.
Examples of social risk factors include,
but are not limited to, dual eligibility/
low-income subsidy, race and ethnicity,
and geographic area of residence. We
are seeking comments on which of these
factors, including current data sources
where this information would be
available, could be used alone or in
combination, and whether other data
should be collected to better capture the
effects of social risk. We will take
commenters’ input into consideration as
we continue to assess the
appropriateness and feasibility of
accounting for social risk factors in the
ESRD QIP. We note that any such
changes would be proposed through
future notice-and-comment rulemaking.
We look forward to working with
stakeholders as we consider the issue of
accounting for social risk factors and
reducing health disparities in the
Medicare programs. Implementing any
of the above methods would be taken
into consideration in the context of how
this and other Medicare programs
operate (for example, data submission
methods, availability of data, statistical
considerations relating to reliability of
data calculations, among others). We
also welcome comment on operational
considerations. CMS is committed to
ensuring that its beneficiaries have
access to and receive excellent care, and
that the quality of care furnished by
facilities is assessed fairly in the
Medicare programs.
C. Proposed Change to the Performance
Score Certificate Beginning With the
Payment Year (PY) 2019 ESRD QIP
In a final rule, which published in the
Federal Register on January 5, 2011, we
finalized a policy for informing the
public of facility performance through
facility-posted certificates (76 FR 637).
We finalized that these Performance
Score Certificates (PSCs) would include
the following information: (1) The TPS
achieved by the facility under the ESRD
QIP with respect to the payment year
involved; (2) comparative data that
shows how well the facility’s TPS
compares to the national TPS; (3) the
performance result that the facility
achieved on each individual measure
with respect to the year involved; and
(4) comparative data that shows how
well the facility’s individual quality
measure performance scores compare to
the national performance result for each
quality measure (76 FR 637). As the
ESRD QIP has become more complex
over the years and as new measures
have been added to the program, the
PSC has become a lengthy document
that facilities are required to print and
post in both English and Spanish for
their patients to view (77 FR 67517). We
have received feedback from the
community about the difficulty patients
and their families have with interpreting
and understanding the information
contained on the PSC due to its sheer
volume and complexity.
Section 1881(h)(6)(C) of the Act only
requires that the PSC indicate the TPS
achieved by the facility with respect to
a program year. Therefore, in an effort
to make the PSC a more effective and
understandable document for the
community, we are proposing to shorten
the PSC by removing some of the
information we had previously finalized
would be included in the document. We
propose that beginning in PY 2019 and
continuing in future years, the PSC will
indicate the facility’s TPS, as required
31203
under section 1881(h)(6)(C) of the Act,
as well as information sufficient to
identify the facility (name, address,
etc.). Additionally, we are proposing to
include on the PSC information
showing how the facility’s TPS
compared to the national average TPS
for that specific payment year.
We are not proposing any other
changes to the requirements we
previously finalized for the PSC.
We seek comments on this proposal,
and we are particularly interested in
comments on whether the reduced
amount of information on the PSC
would both benefit facilities and
enhance the public’s understanding of
the TPS.
D. Proposed Requirements Beginning
With the PY 2020 ESRD QIP
1. Proposal To Clarify the Minimum
Data Policy for Scoring Measures
Finalized for the PY 2020 ESRD QIP
Under our current policy, we begin
counting the number of months in
which a facility is open on the first day
of the month after the facility’s CCN
Open Date. In the CY 2017 ESRD PPS
final rule (81 FR 77926), we
inadvertently made errors in finalizing
how we intended this policy to apply to
a number of measures in the PY 2020
ESRD QIP, and we are proposing the
intended application of this policy for
PY 2020 in this proposed rule. We are
not proposing any changes to the
methodology we use to count the
number of months for which a facility
is open for purposes of scoring facilities
on clinical and reporting measures, or to
the minimum number of cases
(qualifying patients, survey-eligible
patients, index discharges, or patientyears at risk) that applies to each
measure. Table 2 displays the proposed
patient minimum requirements for each
of the measures finalized for PY 2020,
as well as the proposed CCN Open Dates
after which a facility would not be
eligible to receive a score on a reporting
measure.
TABLE 2—PROPOSED MINIMUM DATA REQUIREMENTS FOR THE PY 2020 ESRD QIP
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Measure
Minimum data requirements
CCN open date
Dialysis Adequacy (Clinical).
Vascular Access Type:
Catheter (Clinical).
Vascular Access Type: Fistula (Clinical).
Hypercalcemia (Clinical) ....
NHSN Bloodstream Infection (Clinical).
NHSN Dialysis Event (Reporting).
SRR (Clinical) ....................
11 qualifying patients ....................................................
N/A .....................................
11–25 qualifying patients.
11 qualifying patients ....................................................
N/A .....................................
11–25 qualifying patients.
11 qualifying patients ....................................................
N/A .....................................
11–25 qualifying patients.
11 qualifying patients ....................................................
11 qualifying patients ....................................................
N/A .....................................
Before January 1, 2018 .....
11–25 qualifying patients.
11–25 qualifying patients.
11 qualifying patients ....................................................
Before January 1, 2018 .....
11–25 qualifying patients.
11 index discharges ......................................................
N/A .....................................
11–41 index discharges.
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TABLE 2—PROPOSED MINIMUM DATA REQUIREMENTS FOR THE PY 2020 ESRD QIP—Continued
Measure
Minimum data requirements
CCN open date
Small facility adjuster
STrR (Clinical) ...................
SHR (Clinical) ....................
ICH CAHPS (Clinical) ........
10 patient-years at risk ..................................................
5 patient-years at risk ....................................................
Facilities with 30 or more survey-eligible patients during the calendar year preceding the performance
period must submit survey results. Facilities will not
receive a score if they do not obtain a total of at
least 30 completed surveys during the performance
period.
11 qualifying patients ....................................................
N/A .....................................
N/A .....................................
Before January 1, 2018 .....
10–21 patient years at risk.
5–14 patient-years at risk.
N/A.
Before July 1, 2018 ............
N/A.
11 qualifying patients ....................................................
Before July 1, 2018 ............
N/A.
11 qualifying patients ....................................................
Before July 1, 2018 ............
N/A.
11 qualifying patients ....................................................
Before July 1, 2018 ............
N/A.
N/A .................................................................................
Before January 1, 2018 .....
N/A.
11 qualifying patients ....................................................
Before July 1, 2018 ............
N/A.
Anemia Management (Reporting).
Serum Phosphorus (Reporting).
Depression Screening and
Follow-Up (Reporting).
Pain Assessment and Follow-Up (Reporting).
NHSN Healthcare Personnel Influenza Vaccination (Reporting).
Ultrafiltration Rate (Reporting).
We welcome comments on this
proposal.
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2. Proposed Changes to the
Extraordinary Circumstances Exception
(ECE) Policy
Many of our quality reporting and
value-based purchasing programs share
a common process for requesting an
exception from program reporting due
to an extraordinary circumstance not
within a facility’s control. The Hospital
Inpatient Quality Reporting, Hospital
Outpatient Quality Reporting, Inpatient
Psychiatric Facility Quality Reporting,
Ambulatory Surgical Center Quality
Reporting, PPS-Exempt Cancer Hospital
Quality Reporting, the Hospital
Acquired Condition Reduction Program,
and the Hospital Readmissions
Reduction Program all share common
processes for ECE requests. In reviewing
the policies for these programs, we
recognized that there are five areas in
which these programs have variance in
comparison to the policy within the
ESRD QIP regarding ECE requests.
These are: (1) Allowing the facilities or
hospitals to submit a form signed by the
facility’s or hospital’s CEO versus CEO
or designated personnel; (2) requiring
the form be submitted within 30 days
following the date that the extraordinary
circumstance occurred versus within 90
days following the date the
extraordinary circumstance occurred;
(3) inconsistency regarding specification
of a timeline for us to provide our
response notifying the facility or
hospital of our decision; (4)
inconsistency regarding whether we
would grant ECEs based on a facility’s
inability to timely and completely
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report data due to CMS data system
issues; and (5) referring to this policy as
‘‘extraordinary extensions/exemptions’’
versus as ‘‘extraordinary circumstances
exceptions.’’ We believe that aligning
the way the ECE policy is implemented
in our program, with the way it is
implemented in the programs listed
above, can improve the overall
administrative efficiencies for affected
facilities or hospitals.
In the CY 2015 ESRD PPS final rule
(79 FR 66120 through 66265), we
finalized that to receive consideration
for an exception from the ESRD QIP
requirements in effect during the time
period that a facility is affected by an
extraordinary circumstance, facilities
would need to be closed and provide
CMS with a CMS Disaster Extension/
Exception Request Form within 90
calendar days of the date of the disaster
or extraordinary circumstance (79 FR
66190). We finalized that the facility
would need to provide the following
information on the form:
• Facility CMS Certification Number
(CCN).
• Facility name.
• CEO name and contact information.
• Additional contact name and
contact information.
• Reason for requesting an exception.
• Dates affected.
• Date facility will start submitting
data again, with justification for this
date.
• Evidence of the impact of the
extraordinary circumstances, including
but not limited to photographs,
newspaper, and other media articles.
We also finalized that we would
consider granting an ECE to facilities
absent a request, if we determine that an
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extraordinary circumstance affected an
entire region or locale (79 FR 66190).
We are proposing to update these
policies by: (1) Allowing the facility to
submit a form signed by the facility’s
CEO or designated personnel; (2)
expanding the reasons for which an ECE
can be requested to include an
unresolved issue with a CMS data
system, which affected the ability of the
facility to submit data (an unresolved
data system issue would be one which
did not allow the facility to submit data
by the data submission deadline and
which was unable to be resolved with
a work-around), and (3) specifying that
a facility does not need to be closed in
order to request and receive
consideration for an ECE, as long as the
facility can demonstrate that its normal
operations have been significantly
affected by an extraordinary
circumstance outside of its control.
These proposed policies generally align
with policies in the Hospital Inpatient
Quality Reporting Program (76 FR 51651
through 51652), (78 FR 50836 through
50837) and (81 FR 57181 through
57182), Hospital Outpatient Quality
Reporting Program (77 FR 68489 and 81
FR 79795), as well as ECE policies we
have finalized for other quality
reporting and value-based purchasing
programs. We are proposing that these
policies would apply beginning with the
PY 2020 ESRD QIP program, as related
to extraordinary circumstance events
that occur on or after January 1, 2018.
We note that there may be
circumstances in which it is not feasible
for a facility’s CEO to sign the ECE
request form. In these circumstances, we
believe that facilities affected by such
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circumstances should be able to submit
an ECE request regardless of the CEO’s
availability to sign. This proposed
change would allow facilities to
designate an appropriate, non-CEO
contact for this purpose. We would
accept ECE forms which have been
signed by designated personnel.
Although we do not anticipate that
unresolved issues with CMS data
systems will happen on a regular basis,
we also recognize that there may be
times when CMS experiences issues
with its data systems that inhibits
facilities’ ability to submit data. We are
often able to resolve such issues and
will allow facilities an extended period
of time to report the data. However, in
the case that the issue inhibits the
complete reporting of data (even under
an extended deadline), we believe it
would be inequitable to take the absence
of such unreported data into account
when computing a facility’s TPS for a
payment year. Therefore, we are
proposing to address these situations in
one of two ways. In some cases, CMS
may issue a blanket exemption to
facilities that have been affected by an
unresolved technical issue. In such
cases, facilities would not be required to
submit an ECE request to CMS, and
CMS would send communications about
the blanket waiver to the affected
facilities using routine communication
channels. In other cases, CMS may not
issue a blanket exemption to facilities.
In these cases, facilities would be
required to submit an ECE request to
CMS using the regular ECE request
process, and would need to indicate
how they were directly affected by the
technical issue.
Furthermore, we believe that it is
important for facilities to receive timely
feedback regarding the status of ECE
requests. We strive to complete our
review of each ECE request as quickly
as possible. However, we recognize that
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the number of requests we receive, and
the complexity of the information
provided impacts the actual timeframe
to make ECE determinations. To
improve transparency of our process, we
believe it is appropriate to specify that
we will strive to complete our review of
each request within 90 days of receipt.
We seek comments on these
proposals.
3. Solicitation of Comments on the
Inclusion of Acute Kidney Injury (AKI)
Patients in the ESRD QIP
The services for which quality is
measured under the ESRD QIP are renal
dialysis services defined in section
1881(b)(14)(B) of the Act. Prior to
January 1, 2017, these services could
only be covered and reimbursed under
Medicare if they were furnished to
individuals with ESRD, but they are
now also covered and reimbursed if
they are furnished by renal dialysis
facilities or providers of services paid
under section 1881(b)(14) of the Act to
individuals with acute kidney injury
(AKI) (see section 1861(s)(2)(F) and
1834(r) of the Act).
We currently do not require facilities
to report AKI patient data for any of our
measures in the ESRD QIP, including
the NHSN BSI Clinical and Reporting
Measures.5 However, we now have the
authority to collect data on this patient
population and believe that it is vitally
important to monitor and measure the
quality of care furnished to these
patients.
In the future, we intend to require
facilities to report data on AKI patients
under the ESRD QIP. We are seeking
comments on whether and how to adapt
5 To the extent that the CDC requires facilities to
report AKI patient data under its own, separate,
statutory authority, data on these patients is not
shared with CMS or used in the calculation of any
ESRD QIP measures, including the NHSN Clinical
and Reporting Measures.
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any of our current measures to include
this population, as well as the type of
measures that might be appropriate to
develop for future inclusion in the
program that would address the unique
needs of beneficiaries with AKI.
4. Estimated Performance Standards,
Achievement Thresholds, and
Benchmarks for the Clinical Measures
Finalized for the PY 2020 ESRD QIP
In the CY 2017 ESRD PPS final rule
(81 FR 77834 through 77969), we
finalized that for PY 2020, the
performance standards, achievement
thresholds, and benchmarks for the
clinical measures would be set at the
50th, 15th and 90th percentile,
respectively, of national performance in
CY 2016, because this will give us
enough time to calculate and assign
numerical values to the proposed
performance standards for the PY 2020
program prior to the beginning of the
performance period (81 FR 77915). At
this time, we do not have the necessary
data to assign numerical values to those
performance standards, achievement
thresholds, and benchmarks because we
do not yet have complete data from CY
2016. Nevertheless, we are able to
estimate these numerical values based
on the most recent data available. For
the VAT, Hypercalcemia, NHSN BSI, InCenter Hemodialysis Consumer
Assessment of Healthcare Providers and
Systems (ICH CAHPS), Standardized
Readmission Ratio (SRR), and
Standardized Transfusion Ratio (STrR)
clinical measures, this data comes from
the period of January through December
2015. In Table 3, we have provided the
estimated numerical values for all
finalized PY 2020 ESRD QIP clinical
measures. We will publish updated
values for the clinical measures, using
data from the first part of CY 2017, in
the CY 2018 ESRD PPS final rule.
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In previous rulemaking, we have
finalized that if final numerical values
for the performance standard,
achievement threshold, and/or
benchmark are worse than they were for
that measure in the previous year of the
ESRD QIP, then we would substitute the
previous year’s performance standard,
achievement threshold, and/or
benchmark for that measure. We
finalized this policy because we believe
that the ESRD QIP should not have
lower performance standards than in
previous years. In the CY 2017 ESRD
PPS final rule, we finalized an update
to that policy because in certain cases,
it may be appropriate to re-baseline the
NHSN BSI Clinical Measure, such that
expected infection rates are calculated
on the basis of a more recent year’s data
(81 FR 77886). In such cases, numerical
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values assigned to performance
standards may appear to decline, even
though they represent higher standards
for infection prevention. For PY 2020
and future payment years, we propose
to continue use of this policy for the
reasons explained above. Therefore, for
PY 2020, with the exception of the
NHSN BSI Clinical Measure, we will
substitute the PY 2019 performance
standard, achievement threshold, and/or
benchmark for any measure that has a
final numerical value for a performance
standard, achievement threshold, and/or
benchmark that is worse than it was for
that measure in the PY 2019 ESRD QIP.
Based upon the estimated values shown
above, we do not anticipate needing to
substitute the performance standards
from PY 2019 for any measures
included in the PY 2020 ESRD QIP.
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Although we are not proposing any
changes to this policy, we are seeking
comments on whether we should
continue to use this policy in the future.
5. Policy for Weighting the Clinical
Measure Domain for PY 2020
In the CY 2017 ESRD PPS final rule,
we finalized our policy for weighting
the Clinical Measure Domain for PY
2020. With the addition of the Safety
Measure Domain to the ESRD QIP
Program, we finalized that the Clinical
Measure Domain would comprise 75
percent of the TPS, the Safety Measure
Domain would comprise 15 percent of
the TPS and the Reporting Measure
Domain would comprise 10 percent of
the TPS. Table 4 shows the weights
finalized for PY 2020 for the Clinical
Measure Domain.
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TABLE 4—FINALIZED CLINICAL MEASURE DOMAIN WEIGHTING FOR THE PY 2020 ESRD QIP
Measure weight in the clinical domain score
(percent)
Measures/measure topics by subdomain
Measure weight as percent of TPS
(updated)
Patient and Family Engagement/Care Coordination Subdomain.
ICH CAHPS measure ......................................
SRR Measure ..................................................
Clinical Care Subdomain ........................................
STrR measure .................................................
Dialysis Adequacy measure ............................
VAT measure topic ..........................................
Hypercalcemia measure ..................................
SHR measure ..................................................
40.
25 ...........................................................................
15 ...........................................................................
60.
11 ...........................................................................
18 ...........................................................................
18 ...........................................................................
2 .............................................................................
11 ...........................................................................
18.75.
11.25.
Total ..........................................................
100% (of Clinical Measure Domain) .....................
75% (of TPS).
8.25.
13.5.
13.5.
1.5.
8.25.
Note: The percentages listed in this Table represent the measure weight as a percent of the Clinical Domain Score for PY 2020.
We are not proposing any changes to
these weights finalized in the CY 2017
ESRD PPS final rule at 81 FR 77918.
on the estimated TPS ranges indicated
in Table 5.
TABLE 5—ESTIMATED PAYMENT REDUCTION SCALE FOR PY 2020
BASED ON THE MOST RECENTLY
AVAILABLE DATA
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6. Proposed Payment Reductions for the
PY 2020 ESRD QIP
Section 1881(h)(3)(A)(ii) of the Act
requires the Secretary to ensure that the
application of the ESRD QIP scoring
methodology results in an appropriate
distribution of payment reductions
across facilities, such that facilities
achieving the lowest TPS receive the
largest payment reductions. In the CY
2017 ESRD PPS final rule, we finalized
our proposal for calculating the
minimum TPS for PY 2020 and future
payment years (81 FR 77927). Under our
current policy, a facility will not receive
a payment reduction if it achieves a
minimum TPS that is equal to or greater
than the total of the points it would
have received if: (1) It performs at the
performance standard for each clinical
measure; and (2) it receives the number
of points for each reporting measure that
corresponds to the 50th percentile of
facility performance on each of the PY
2018 reporting measures (81 FR 77927).
We were unable to calculate a
minimum TPS for PY 2020 in the CY
2017 ESRD PPS final rule because we
were not yet able to calculate the
performance standards for each of the
clinical measures. We therefore stated
that we would publish the minimum
TPS for the PY 2020 ESRD QIP in the
CY 2018 ESRD PPS final rule (81 FR
77927).
Based on the estimated performance
standards listed above, we estimate that
a facility must meet or exceed a
minimum TPS of 61 for PY 2020. For all
of the clinical measures, these data
come from CY 2015. We are proposing
that a facility failing to meet the
minimum TPS, which we will finalize
in the CY 2018 ESRD PPS final rule,
will receive a payment reduction based
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Total performance score
100–61 ........................................
60–51 ..........................................
50–41 ..........................................
40–31 ..........................................
30–21 ..........................................
Reduction
(%)
0
0.5
1.0
1.5
2.0
7. Data Validation
One of the critical elements of the
ESRD QIP’s success is ensuring that the
data submitted to calculate measure
scores and TPSs are accurate. We began
a pilot data validation program in CY
2013 for the ESRD QIP, and procured
the services of a data validation
contractor that was tasked with
validating a national sample of facilities’
records as reported to CROWNWeb. For
validation of CY 2014 data, our priority
was to develop a methodology for
validating data submitted to
CROWNWeb under the pilot data
validation program. That methodology
was fully developed and adopted
through the rulemaking process. For the
PY 2016 ESRD QIP (78 FR 72223
through 72224), we finalized a
requirement to sample approximately 10
records from 300 randomly selected
facilities; these facilities had 60 days to
comply once they received requests for
records. We continued this pilot for the
PY 2017, PY 2018 and PY 2019 ESRD
QIP, and propose to continue doing so
for the PY 2020 ESRD QIP. Using the
data collected thus far, we are exploring
options for refining the methodology
used in order to improve the
effectiveness and reliability of the data
collected. For future payment years, we
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will consider whether this validation
effort should continue in pilot status or
as a permanent feature of the ESRD QIP
program. Under the continued
validation study, we will sample the
same number of records (approximately
10 per facility) from the same number of
facilities, which totaled 300 facilities
during CY 2018. If a facility is randomly
selected to participate in the pilot
validation study but does not provide us
with the requisite medical records
within 60 calendar days of receiving a
request, then we propose to deduct 10
points from the facility’s TPS.
In the CY 2015 ESRD PPS final rule
(79 FR 66120 through 66265), we also
finalized that there would be a
feasibility study for validating data
reported to CDC’s NHSN Dialysis Event
Module for the NHSN BSI Clinical
Measure (OMB #0938–NEW).
Healthcare-acquired infections are
relatively rare, and we finalized that the
feasibility study would target records
with a higher probability of including a
dialysis event, because this would
enrich the validation sample while
reducing the burden on facilities. This
methodology resembles the
methodology we use in the Hospital
Inpatient Quality Reporting Program to
validate the central line-associated BSI
measure, the catheter-associated urinary
tract infection measure, and the surgical
site infection measure (77 FR 53539
through 53553).
For the PY 2020 ESRD QIP, we
propose to continue conducting the
same NHSN dialysis event validation
study, that we finalized in the CY 2017
ESRD PPS final rule for PY 2019 (81 FR
77894). For PY 2020, we would
continue to select 35 facilities to
participate in an NHSN dialysis event
validation study by submitting 10
patient records covering two quarters of
data reported in CY 2018. However, for
PY 2020, the sampling method used to
select the 35 facilities would be adjusted
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such that a more representative sample
of facility data can be analyzed,
including data from high performing
facilities as well as facilities identified
as being at risk of underreporting. A
CMS contractor would send these
facilities requests for medical records
for all patients with ‘‘candidate events’’
during the evaluation period; that is,
patients who had any positive blood
cultures; received any intravenous
antimicrobials; had any pus, redness, or
increased swelling at a vascular access
site; and/or were admitted to a hospital
during the evaluation period. Facilities
would have 60 calendar days to respond
to the request for medical records based
on candidate events either electronically
or on paper. If the contractor determines
that additional medical records are
needed to reach the 10-record threshold
from a facility to validate whether the
facility accurately reported the dialysis
events, then the contractor would send
a request for additional, randomly
selected patient records from the
facility. The facility would have 60
calendar days from the date of the letter
to respond to the request. With input
from CDC, the CMS contractor would
utilize a methodology for reviewing and
validating records from selected
patients, in order to determine whether
the facility reported dialysis events for
those patients in accordance with the
NHSN Dialysis Event Protocol. If a
facility is selected to participate in the
validation study but does not provide
CMS with the requisite lists of
information or medical records within
60 calendar days of receiving a request,
then we propose to deduct 10 points
from the facility’s TPS. Information
from the validation study may be used
in future years of the program to inform
our consideration of future policies that
would incorporate NHSN data accuracy
into the scoring process. In future years
of the program we may also look to
improve the NHSN dialysis event
validation study by validating records
from a greater number of facilities or by
validating a larger sample of records
from each facility participating in the
study.
E. Proposed Requirements for the PY
2021 ESRD QIP
1. Proposed Measures for the PY 2021
ESRD QIP
We previously finalized 16 measures
in the CY 2017 ESRD PPS final rule for
the PY 2020 ESRD QIP. In accordance
with our policy to continue using
measures unless we propose to remove
or replace them, (77 FR 67477), we will
continue to use all but 2 of these
measures in the PY 2021 ESRD QIP.
These measures are summarized in
Table 6 below. We are proposing to
replace the two VAT Clinical Measures
with the proposed Hemodialysis
Vascular Access: Standardized Fistula
Rate Clinical Measure and the proposed
Hemodialysis Vascular Access: LongTerm Catheter Rate Clinical Measure
beginning with PY 2021.
TABLE 6—PY 2020 ESRD QIP MEASURES BEING CONTINUED IN PY 2021
NQF No.
Measure title and description
0258 .........................................
ICH CAHPS Survey Administration, a clinical measure. Measure assesses patients’ self-reported experience of
care through percentage of patient responses to multiple testing tools.
SRR, a clinical measure. Ratio of the number of observed unplanned 30-day hospital readmissions to the number of expected unplanned 30-day readmissions.
STrR, a clinical measure. Risk-adjusted standardized transfusion ratio for all adult Medicare dialysis patients.
Number of observed eligible red blood cell transfusion events occurring in patients dialyzing at a facility to
the number of eligible transfusions that would be expected.
Kt/V Dialysis Adequacy Comprehensive, a clinical measure. Percentage of all patient months for patients
whose delivered dose of dialysis (either hemodialysis or peritoneal dialysis) met the specified threshold during the reporting period.
Hypercalcemia, a clinical measure. Proportion of patient-months with 3-month rolling average of total uncorrected serum or plasma calcium greater than 10.2 mg/dL.
SHR, a clinical measure. Risk-adjusted SHR of the number of observed hospitalizations to the number of expected hospitalizations.
Serum Phosphorus, a reporting measure. Percentage of all adult (≥18 years of age) peritoneal dialysis and
hemodialysis patients included in the sample for analysis with serum or plasma phosphorus measured at
least once within month.
Anemia Management Reporting, a reporting measure. Number of months for which facility reports
erythropoiesis-stimulating agent (ESA) dosage (as applicable) and hemoglobin/hematocrit for each Medicare
patient, at least once per month.
Pain Assessment and Follow-Up, a reporting measure. Facility reports in CROWNWeb one of six conditions for
each qualifying patient once before August 1 of the performance period and once before February 1 of the
year following the performance period.
Clinical Depression Screening and Follow-Up, a reporting measure. Facility reports in CROWNWeb one of six
conditions for each qualifying patient once before February 1 of the year following the performance period.
NHSN Healthcare Personnel Influenza Vaccination, a reporting measure. Facility submits Healthcare Personnel
Influenza Vaccination Summary Report to CDC’s NHSN system, according to the specifications of the
Healthcare Personnel Safety Component Protocol, by May 15 of the performance period.
Ultrafiltration Rate, a reporting measure. Number of months for which a facility reports elements required for
ultrafiltration rates for each qualifying patient.
NHSN BSI in Hemodialysis Patients, a clinical measure. The Standardized Infection Ratio (SIR) of BSIs will be
calculated among patients receiving hemodialysis at outpatient hemodialysis centers.
NHSN Dialysis Event Reporting Measure. Number of months for which facility reports NHSN Dialysis Event
data to CDC.
2496 .........................................
2979 .........................................
N/A ...........................................
1454 .........................................
1463 * .......................................
0255 .........................................
N/A ...........................................
Based on NQF #0420 ..............
Based on NQF #0418 ..............
Based on NQF #0431 ..............
N/A ...........................................
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Based on NQF #1460 ..............
N/A ...........................................
* We note that the complete lists of ICD–10 codes associated with the Standardized Readmission Ratio Clinical Measure and the Standardized
Hospitalization Ratio Clinical Measure included in the ESRD QIP for PY 2020 are included in the Measure Technical Reports, available here:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ESRDQIP/061_TechnicalSpecifications.html.
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2. Proposed Replacement of the
Vascular Access Type (VAT) Clinical
Measures Beginning With the PY 2021
Program Year
We consider a quality measure for
removal or replacement if: (1) Measure
performance among the majority of
ESRD facilities is so high and unvarying
that meaningful distinctions in
improvements or performance can no
longer be made (in other words, the
measure is topped-out); (2) performance
or improvement on a measure does not
result in better or the intended patient
outcomes; (3) a measure no longer aligns
with current clinical guidelines or
practice; (4) a more broadly applicable
(across settings, populations, or
conditions) measure for the topic
becomes available; (5) a measure that is
more proximal in time to desired patient
outcomes for the particular topic
becomes available; (6) a measure that is
more strongly associated with desired
patient outcomes for the particular topic
becomes available; or (7) collection or
public reporting of a measure leads to
negative or unintended consequences
(77 FR 67475). In the CY 2015 ESRD
PPS final rule, we adopted statistical
criteria for determining whether a
clinical measure is topped out, and
adopted a policy under which we could
retain an otherwise topped-out measure
if we determined that its continued
inclusion in the ESRD QIP measure set
would address the unique needs of a
specific subset of the ESRD population
(79 FR 66174).
Subsequent to the publication of the
CY 2017 ESRD PPS final rule, we
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evaluated the finalized PY 2020 ESRD
QIP measures that would be continued
in PY 2021 against all of these criteria.
We determined that none of these
measures met criterion (1), (2), (3), (4),
(5) or (7). As part of this evaluation for
criterion one, we performed a statistical
analysis of the PY 2020 measures we
plan to continue using for PY 2021 and
future payment years to determine
whether any measures were ‘‘topped
out.’’ The full results of this analysis can
be found at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/ESRDQIP/061_
TechnicalSpecifications.html and a
summary of our topped-out analysis
results appears in Table 7.
As Table 7 illustrates, the
distributions of the PY 2020 clinical
measures were assessed in order to
determine if any measures were ‘‘topped
out.’’ In order for a measure to be
considered topped out, two conditions
had to be met. First, a measure was
considered topped out if the 75th
percentile, or 25th percentile for
measures where lower percentiles
indicate better performance, was
statistically indistinguishable from the
90th (or 10th) percentile, and second,
the truncated coefficient of variation
(TCV) was less than or equal to 10
percent, or 0.10. We note that the
percentiles were considered statistically
indistinguishable if the 75th/25th
percentile was within two standard
errors of the 90th/10th percentile.
Additionally, for each measure the TCV
was calculated by first removing the
lower and upper 5th percentiles, then
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dividing the standard deviation by the
mean of this truncated distribution
(SDtruncated/Meantruncated). The TCV was
then converted to a decimal by dividing
the TCV by 100.
Measures evaluated included the
combined Kt/V (that is, a measure of
dialysis adequacy where K is dialyzer
clearance, t is dialysis time, and V is
total body water volume measure),
Fistula, Catheter, Hypercalcemia, NHSN
Standardized Infection Ratio (SIR), SRR,
STrR, SHR, and the six individual
CAHPS clinical measures. Medicare
claims data from 2015 were used in
Fistula and Catheter calculations.
CROWNWeb data from 2015 was used
for Hypercalcemia, the combination of
2015 CROWNWeb data and 2015
Medicare claims data were used for Kt/
V measure, and the SRR, STrR, and SHR
measures were based on both
combination of 2014 CROWNWeb data
and 2014 Medicare claims data. The
NHSN BSI Clinical Measure was
calculated using the CY 2015 NHSN
data from the CDC, and the six
components of the ICH–CAHPS measure
were calculated using the CY 2015 ICH–
CAHPS data.
Table 7 presents the percentiles,
standard error, and TCV for each
measure. In this analysis, all facilities
with the minimum eligible patient
requirement per measure were included.
The results indicate none of the PY 2020
clinical measures met both ‘‘topped
out’’ conditions.
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As the information in Table 7 indicates,
none of these clinical measures are
currently topped-out in the ESRD QIP.
Accordingly, we are not proposing to
remove any of these measures from the
ESRD QIP for PY 2021 because they are
topped out.
Over the past few years, we have
received numerous public comments
regarding the two VAT measures
included in the ESRD QIP’s measure set.
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Specifically, commenters have
recommended that CMS adjust the
weights of the VAT measures to place
more emphasis on reducing catheters to
encourage the use of fistulas and grafts
(81 FR 77904). Another commenter
specifically supported CMS’ submission
of new VAT Measures to the NQF Renal
Standing Committee to address the
small number of patients for whom a
catheter may be the most appropriate
vascular access type when life
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expectancy is limited (81 FR 77905). We
also note that the VAT measures
currently used in the ESRD QIP measure
set are calculated using claims data.
This limits the applicability of the
measures to Medicare Fee-For-Service
(FFS) patients, while excluding all
others.
Although there is no evidence to
suggest that the current VAT measures
are leading to negative or unintended
consequences, we are proposing to
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remove both from the ESRD QIP
measure set beginning with the PY 2021
program based on criterion (6) listed
earlier, because measures that are more
strongly associated with desired patient
outcomes for the particular topic are
now available. As discussed more fully
below, we are proposing to replace the
VAT measures with the Proposed
Hemodialysis Vascular Access:
Standardized Fistula Rate Clinical
Measure (NQF #2977) and the Proposed
Hemodialysis Vascular Access: LongTerm Catheter Rate Clinical Measure
(NQF #2978). These proposed measures
will address the methodological
concerns the community has shared
regarding the existing measures.
Additionally, they have both been
endorsed by the NQF and are supported
by the Measures Application
Partnership. Both of the proposed
measures are being considered for
reporting on Dialysis Facility Compare
and in the Dialysis Facility Compare
Star Ratings for 2018 and both measures
can be calculated using data that
facilities are already required to report
in CROWNWeb in order to meet 42 CFR
494.180(h) of the 2008 updated
Conditions for Coverage for ESRD
Dialysis Facilities. Because CROWNWeb
collects data on all patients, we believe
that the adoption of these measures will
enable us to more accurately assess the
quality of care furnished by facilities.
We seek comments on our proposal to
remove the current VAT measures from
the ESRD QIP measure set beginning
with the PY 2021 program year.
3. Proposed Revision of the
Standardized Transfusion Ratio (STrR)
Clinical Measure Beginning With the PY
2021 Program Year
We believe that changes during the
past several years to the way ESRD
services are reimbursed under Medicare,
as well as changes to how ESRD care is
measured under the ESRD QIP and
through other quality reporting
initiatives, may have impacted how
anemia is clinically managed. Some of
these changes include the identification
of safety concerns associated with
aggressive erythropoiesis-stimulating
agent (ESA) use, the expansion of the
ESRD PPS bundled payment
methodology to include ESAs, and the
continued growth and expansion of the
ESRD QIP. There are concerns that these
changes could result in the
underutilization of ESAs, with lower
achieved hemoglobin values that may
increase the frequency of red blood cell
transfusion in the US chronic dialysis
population.
Excessive rates of blood transfusion
may be an indicator for underutilization
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of clinical treatments to increase
endogenous red blood cell production
(for example, ESA, iron). Dialysis
patients who are eligible for kidney
transplant and have received
transfusions are at increased risk of
becoming sensitized to the donor pool
thereby making transplant more difficult
to accomplish. Blood transfusions carry
a small risk of transmitting blood borne
infections and/or the development of a
transfusion reaction, and using infusion
centers or hospitals to transfuse patients
is expensive, inconvenient, and could
compromise future vascular access.6
Monitoring the risk-adjusted
transfusion rate at the dialysis facility
level, relative to national standards,
allows for detection of treatment
patterns in dialysis-related anemia
management. This is of particular
importance due to recommendations by
the Food and Drug Administration
regarding more conservative ESA
dosing.7 As providers use less ESAs in
an effort to minimize the risks
associated with aggressive anemia
treatment, it becomes more important to
monitor for an overreliance on
transfusions. Beginning with PY 2017,
we adopted the STrR to address gaps in
the quality of anemia management. We
also submitted that measure to the NQF
for consensus endorsement, but the
Renal Standing Committee did not
recommend it for endorsement, in part
due to concerns that variability in
hospital coding practices with respect to
the use of 038 and 039 revenue codes
might unduly bias the measure rates.
Upon reviewing the committee’s
feedback, we revised the STrR measure
to address these concerns. Following
this revision, we resubmitted the STrR
(NQF #2979) to NQF for consensus
endorsement, and the NQF endorsed it
in 2016. The change we are proposing
to the STrR beginning with the PY 2021
ESRD QIP will align the measure
specifications we use for the ESRD QIP
6 FDA Drug Safety Communication: Modified
dosing recommendations to improve the safe use of
Erythropoiesis-Stimulating Agents (ESAs) in
chronic kidney disease. https://www.fda.gov/Drugs/
DrugSafety/ucm259639.htm.
Kidney Disease: Improving Global Outcome
(KDIGO) Anemia Work Group. KDIGO Clinical
Practice Guideline for Anemia in Chronic Kidney
Disease. Kidney inter., Suppl. 2012; 2: 279–335.
https://www.kdigo.org/clinical_practice_guidelines/
pdf/KDIGO-Anemia%20GL.pdf.
Obrador and Macdougall. Effect of Red Cell
Transfusions on Future Kidney Transplantation.
Clin J Am Soc Nephrol 8: 852–860, 2013.
Ibrahim, et al. Blood transfusions in kidney
transplant candidates are common and associated
with adverse outcomes. Clin Transplant 2011: 25:
653–659.
7 https://www.fda.gov/Drugs/DrugSafety/
ucm259639.htm.
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31211
with the measure specifications that the
NQF endorsed in 2016 (NQF #2979).
Summary of Change
The proposed updated specifications
to the STrR measure contain a more
restricted definition of transfusion
events than is used in the current STrR
measure. Specifically, the revised
definition excludes inpatient
transfusion events for claims that
include only 038 or 039 revenue codes
without an accompanying ICD–9 or
ICD–10 Procedure Code or Value Code.
As a result of requiring that all inpatient
transfusion events include an
appropriate ICD–9 or ICD–10 Procedure
Code or Value Code, the measure will
identify transfusion events more
specifically and with less bias related to
regional coding variation. As a result, it
will assess a smaller number of events
as well as a smaller range of total events.
2016 Measures Application Partnership
Review
We determined that the proposed
revision to the STrR (NQF #2979)
constituted a substantive change to the
measure, and we submitted that revision
to the Measures Application Partnership
for consideration as part of the prerulemaking process. The Measures
Application Partnership recommended
that this measure be refined and
resubmitted due to concerns that
measuring transfusions in dialysis
facilities may not be feasible.8 The
Measures Application Partnership also
expressed concern that the decision to
administer a blood transfusion may be
outside of the dialysis facility’s control
because in general, clinicians in
hospitals make the decisions about
blood transfusions. The Measures
Application Partnership also expressed
concern that variability in blood
transfusion coding practices could
inadvertently affect a dialysis facility’s
performance on this measure.
Although we acknowledge that the
Measures Application Partnership
recommended that we refine and
resubmit the updated version of the
STrR measure, we note that the
Measures Application Partnership’s
recommendation is at odds with the
earlier conclusion of the NQF to endorse
this change. On the issue of whether it
is feasible to measure transfusions in
dialysis facilities, the NQF concluded
that these events can be identified using
the same Medicare claims code
algorithm that we use to identify
transfusion events in other outpatient
settings. The STrR measure identifies
8 https://www.qualityforum.org/WorkArea/
linkit.aspx?LinkIdentifier=id&ItemID=84452.
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sradovich on DSK3GMQ082PROD with PROPOSALS2
transfusion events during at-risk periods
for patients cared for in a dialysis
facility.
With respect to the MAP’s concern
that the decision to administer a blood
transfusion might be outside of the
dialysis facility’s control, we note that
the issue of whether anemia
management practices in a dialysis
facility can be linked to transfusion risk
was specifically considered by the NQF
during the endorsement process.
The NQF Renal Standing Committee
concluded that this transfusion
avoidance measure would incentivize
facilities to properly manage anemia,
with the result of lowering the patient’s
transfusion risk. The NQF Renal
Standing Committee also found that
although the decision to transfuse might
ultimately be made by a hospital, the
need to do so is dictated not only by
clinical circumstances observed by the
hospital, but also by the way the
patient’s anemia was managed by the
facility.
Although the Measures Application
Partnership was concerned that
variability in blood transfusion coding
practices could inadvertently affect a
dialysis facility’s performance on this
measure, we note that the definition of
transfusion events used in the revised
STrR measure is consistent with the
definition used in numerous scientific
publications, including several peer
reviewed publications.9 Under this
definition, transfusion events are
included in the measure only if they are
coded with specific transfusion
procedure or value codes. We believe
this coding requirement reduces the
potential for inadvertently capturing
non-transfusion events in the measure.
9 Hirth, Turenne, Wilk et al. Blood transfusion
practices in dialysis patients in a dynamic
regulatory environment. Am J Kidney Dis. 2014
Oct;64(4):616–21. Doi: 10.1053/j.ajkd.2014.01.011.
Epub 2014 Feb 19.
Gilbertson, Monda, Bradbury & Collins. RBC
Transfusions Among Hemodialysis Patients (1999–
2010): Influence of Hemoglobin Concentrations
Below 10 g/dL. Am J Kidney Dis. 2013; Volume 62,
Issue 5, 919–928.
Collins et al. Effect of Facility-Level Hemoglobin
Concentration on Dialysis Patient Risk of
Transfusion. Am J Kidney Dis. 2014; 63(6):997–
1006.
Cappell et al. Red blood cell (RBC) transfusion
rates among US chronic dialysis patients during
changes to Medicare end-stage renal disease (ESRD)
reimbursement systems and erythropoiesis
stimulating agent (ESA) labels. BMC Nephrology
2014, 15:116.
Ibrahim, et al. Blood transfusions in kidney
transplant candidates are common and associated
with adverse outcomes. Clin Transplant 2011: 25:
653–659.
Molony, et al. Effects of epoetin alfa titration
practices, implemented after changes to product
labeling, on hemoglobin levels, transfusion use, and
hospitalization rates. Am J Kidney Dis 2016: epub
before print (published online March 12, 2016).
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In addition, the exclusion of revenue
code only transfusion events from the
measure decreases the potential that the
measure results would be influenced by
differences in hospital coding practices.
We agree with the NQF Standing
Committee’s assessment that the STrR
(NQF #2979) is an appropriate measure
of quality for dialysis facilities. We
further believe that the measure is
appropriate for the ESRD QIP because
the measure (1) demonstrates variation
in performance among facilities, (2) is
an outcome of care that is modifiable by
dialysis providers through effective
management of anemia in patients, and
(3) is a valid and reliable indicator of
quality at the facility level. Proper
management of anemia is an important
quality of care issue for dialysis
patients, and a topic for which the ESRD
QIP must include measures (see section
1881(h)(2)(A)(i)).
For these reasons, we believe the
revision to the STrR measure should be
reflected in the ESRD QIP, and
beginning with the PY 2021 program
year, we propose to use the updated
version of the STrR (NQF #2979). Full
measure specifications and testing data
are available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/ESRDQIP/061_
TechnicalSpecifications.html.
We note that the complete list of ICD–
10 codes that would be included in the
measure is included in the Technical
Report for the measure, provided at the
link listed above.
We seek comments on this proposal.
4. Proposed New Vascular Access
Measures Beginning With the PY 2021
ESRD QIP
As discussed in sections IV.E.4,
IV.E.4.a, and IV.E.4.b of this proposed
rule, for PY 2021, we propose to remove
the two VAT measures from the ESRD
QIP and to replace them with two
Vascular Access measures that were
recently endorsed by the NQF. We are
proposing to score these measures the
same way that we score the current VAT
measures, and to include them within
the Vascular Access Measure Topic.
Background
Beginning with the PY 2015 ESRD
QIP, we adopted the Minimizing
Catheter Use as Chronic Dialysis Access
(NQF #0256) and Maximizing
Placement of Arterial Venous (AV)
fistula (NQF #0257), paired measures of
the rate of catheter and fistula
placement for chronic dialysis access,
respectively, for the ESRD QIP (77 FR
67479). These measures were developed
in accordance with the National Kidney
Foundation Kidney Disease Outcomes
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Quality Initiative Guidelines that state
the following: (1) AV fistulas have the
lowest rate of thrombosis and require
the fewest interventions, (2) cost of AV
fistula use and maintenance is the
lowest, (3) fistulas have the lowest rates
of infection, and (4) fistulas are
associated with the highest survival and
lowest hospitalization rates. A number
of epidemiologic studies consistently
demonstrate the reduced morbidity and
mortality associated with greater use of
AV fistulas for vascular access in
maintenance hemodialysis.
Based upon data we collected during
the CMS Fistula First/Catheter Last
Initiative,10 a gradual trend towards
lower catheter use has been observed
among prevalent maintenance
hemodialysis patients in the United
States, declining from approximately 28
percent in 2006 to approximately 18
percent by August 2015. Furthermore,
the percentage of maintenance HD
patients using a catheter for at least 3
months has declined during this time
period from nearly 12 percent to 10.8
percent. Continued monitoring of
chronic catheter use is needed to sustain
this trend.
Since the Maximizing Placement of
AV fistula (NQF #0257) was first
implemented, we have received public
comments expressing concerns that in
certain cases, such as patients with a
low life expectancy, placement of a
fistula may not be appropriate. A
growing number of studies report that
creating AV fistulas in some patients is
less likely to be successful in the
presence of certain comorbidities. In
addition, certain patient groups may
have less incremental benefit from an
AV fistula relative to an AV graft.
Since the implementation of
Minimizing Catheter Use as Chronic
Dialysis Access (NQF #0256), we have
received comments from stakeholders
raising concerns about its inability to
account for patients with a limited life
expectancy, for whom a fistula, with its
extended maturation period, may not
represent an improved quality of life. By
incorporating additional exclusion
criteria to account for such patients, this
measure avoids setting a quality
standard that may penalize facilities for
providing appropriate vascular access.
In 2015, we convened a Technical
Expert Panel (TEP) to review the
existing vascular access measures to
consider how best to address these
concerns. A copy of the summary TEP
report is available at https://
www.cms.gov/Medicare/Quality10 Fistula First Catheter Last Dashboard August
2015 https://fistulafirst.esrdncc.org/ffcl/for-ffclprofessionals/archive/.
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Initiatives-Patient-AssessmentInstruments/ESRDQIP/061_
TechnicalSpecifications.html. The TEP
made the following recommendations:
• The fistula measure should be riskadjusted for factors that are associated
with decreased likelihood of AV fistula
success, including:
++ Diabetes.
++ Heart diseases.
++ Peripheral vascular disease.
++ Cerebrovascular disease.
++ Chronic obstructive pulmonary
disease.
++ Anemia (unrelated to ESRD/
Chronic Kidney Disease).
++ Non-Vascular Access-Related
Infections.
++ Drug Dependence.
• The measures should include all
eligible hemodialysis patients, not just
Medicare beneficiaries.
• The measures should include
patients in the first 90 days of dialysis
because this is a critical time for access
planning/placement.
• The measures should include in the
numerator only patients with an AV
fistula using 2 needles (or an approved
single needle device).
• The measures should exclude
conditions associated with a limited life
expectancy where an AV fistula may not
be the appropriate choice for access (for
example, hospice, metastatic cancer,
end stage liver disease, and coma/brain
injury).
We responded to the TEP’s
recommendations by developing two
new VAT measures intended to be
jointly reported to assess the placement
of vascular access among ESRD dialysis
patients. These two vascular access
quality measures, when used together,
consider AV fistula use as a positive
outcome and prolonged use of a
tunneled catheter as a negative outcome.
With the growing recognition that some
patients have exhausted options for an
AV fistula or have comorbidities that
may limit the success of AV fistula
creation, joint reporting of the measures
accounts for all three vascular access
options. This paired incentive structure
that relies on both measures
(standardized fistula rate and long-term
catheter rate) reflects consensus-based
best practice, and supports maintenance
of the gains in vascular access success
achieved via the Fistula First/Catheter
Last Project over the last decade.
fistula, and it incorporates changes that
reflect input from the 2015 Vascular
Access TEP:
• Risk Adjustment for the following
conditions that affect the success of
fistula placement:
++ Diabetes.
++ Heart diseases.
++ Peripheral vascular disease.
++ Cerebrovascular disease.
++ Chronic obstructive pulmonary
disease.
++ Anemia (unrelated to ESRD/
Chronic Kidney Disease).
++ Non-Vascular Access-Related
Infections.
++ Drug Dependence.
• Inclusion of all eligible
hemodialysis patients, not just Medicare
beneficiaries.
• Inclusion of patients in the first 90
days of dialysis because this is a critical
time for access planning/placement.
• Inclusion in the numerator of only
patients with an AV fistula using 2
needles (or an approved single needle
device).
• Exclusion of conditions associated
with a limited life expectancy where an
AV fistula may not be the appropriate
choice for access (for example, hospice,
metastatic cancer, end-stage liver
disease, and coma/brain injury).
a. Proposed New Hemodialysis Vascular
Access: Standardized Fistula Rate
Clinical Measure (NQF #2977)
Cohort
Summary of Changes
This proposed measure replaces NQF
#0257, Maximizing Placement of AV
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Data Sources
CROWNWeb, Medicare claims and
the CMS Medical Evidence form 2728
(OMB No. 0938–0046) are used as the
data sources for establishing the
denominator. CROWNWeb is the data
source for establishing the numerator.
Medicare claims and the CMS Medical
Evidence form 2728 are data sources for
the risk adjustment factors. Medicare
claims and CROWNWeb are used for the
exclusion criteria. Using CROWNWeb as
the primary data source allows us to
expand the Standardized Fistula Rate to
include all ESRD dialysis patients,
rather than only Medicare FFS patients,
providing a more complete quality
assessment for dialysis facilities. This
was a key consideration by the TEP that
recommended the development of this
measure.
Outcome
The outcome of the Standardized
Fistula Rate is the use of an AV fistula
as the sole means of vascular access as
of the last hemodialysis treatment
session of the month.
The cohort includes adult ESRD
dialysis patients who are determined to
be maintenance hemodialysis patients
(in-center or home) for the entire
reporting month at the same facility.
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Inclusion and Exclusion Criteria
The Standardized Fistula Rate
excludes pediatric patients (<18 years
old), patients on peritoneal dialysis, and
patient-months where the patient was
not on hemodialysis (in-center or home)
at the same facility for the entire
reporting month. The measure
additionally excludes patients with a
catheter who have a limited life
expectancy.
Risk Adjustment
The Standardized Fistula Rate is a
directly standardized percentage, with
each facility’s percentage of fistula use
adjusted by a series of risk factors,
including patient demographic and
clinical characteristics based on a
logistic regression model. The
demographic and clinical characteristics
were chosen in order to adjust for
factors outside the control of a facility
that are associated with a decreased
likelihood of AV fistula success.
We submitted the measure to NQF,
where the Renal Standing Committee
recommended it for consensus
endorsement, and the NQF endorsed the
measure in December 2016. The
Standardized Fistula Rate (NQF #2977)
was submitted to the Measure
Applications Partnership in 2016,
which supported the measure for
implementation in the ESRD QIP.
We propose implementing
Hemodialysis Vascular Access:
Standardized Fistula Rate (NQF #2977)
beginning with the PY 2021 program
year. Detailed measure specifications
and testing data are available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/ESRDQIP/061_
TechnicalSpecifications.html. We seek
comments on this proposal.
b. Proposed New Hemodialysis Vascular
Access: Long-Term Catheter Rate (NQF
#2978) Beginning With the PY 2021
ESRD QIP
Summary of Changes
This proposed measure replaces NQF
#0256, Minimizing Use of Catheters as
Chronic Dialysis Access, and it
incorporates the following changes that
reflect input from the 2015 Vascular
Access TEP:
• Inclusion of all eligible
hemodialysis patients, not just Medicare
beneficiaries, since the measure is now
specified to be calculated from
CROWNWeb.
• Patients using a catheter
continuously for 3 months or longer,
even if combined with an AV fistula (or
graft), are now counted in the
numerator. The current measure does
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not count patients in the numerator if
they have a catheter combined with an
AV fistula or graft.
• Patients with missing VAT are
counted in both the denominator and
the numerator. That is, ‘‘missing’’ access
type is considered a ‘‘failure’’ and
therefore counts against the facility.
• Exclusion criteria have been added
to the measure for conditions associated
with a limited life expectancy where a
catheter may be an appropriate choice
for access. These are the same
exclusions applied to the Standardized
Fistula Rate measure (for example,
hospice, metastatic cancer, end stage
liver disease, and coma/brain injury).
Data Sources
CROWNWeb, Medicare Claims and
the CMS Medical Evidence form 2728
are used as the data sources for
establishing the denominator.
CROWNWeb is the data source for
establishing the numerator. Medicare
claims and CROWNWeb are used for the
exclusion criteria. Medicare claims and
the CMS Medical Evidence Form 2728
are used for risk adjustment. Using
CROWNWeb as the primary data source
allows us to expand the Long-Term
Catheter Rate to include all ESRD
dialysis patients, rather than only
Medicare FFS patients, providing a
more complete quality assessment for
dialysis facilities. This was a key
consideration by the TEP that
recommended the development of this
measure.
Outcome
The outcome of the Long-Term
Catheter Rate is the use of a catheter
continuously for 3 months or longer as
of the last hemodialysis treatment
session of the month.
sradovich on DSK3GMQ082PROD with PROPOSALS2
Cohort
The cohort includes adult ESRD
dialysis patients who are determined to
be maintenance hemodialysis patients
(in-center or home) for the entire
reporting month at the same facility.
Inclusion and Exclusion Criteria
The Long-Term Catheter Rate
excludes pediatric patients (<18 years
old), patients on peritoneal dialysis, and
patient-months not on hemodialysis (incenter or home) for the entire reporting
month at the same facility. The measure
additionally excludes patients with a
catheter who have a limited life
expectancy.
We submitted the Long-Term Catheter
Rate (NQF #2978) to NQF, where the
Renal Standing Committee
recommended it for consensus
endorsement, and the NQF endorsed the
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measure in December 2016. The
measure was submitted to the Measure
Application Partnership in 2016, which
supported it for implementation in the
ESRD QIP.
We propose to introduce the LongTerm Catheter Rate (NQF #2978) into
the ESRD QIP beginning with the PY
2021 program year. Full measure
specifications and testing data are
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/ESRDQIP/061_
TechnicalSpecifications.html.
We seek comments on this proposal.
CY 2017, because this will give us
enough time to calculate and assign
numerical values to the proposed
performance standards for the PY 2021
program prior to the beginning of the
performance period. We continue to
believe these standards will provide an
incentive for facilities to continuously
improve their performance, while not
reducing incentives to facilities that
score at or above the national
performance rate for the clinical
measures.
We seek comments on our proposal to
continue this policy for PY 2021.
5. Proposed Performance Period for the
PY 2021 ESRD QIP
We are proposing to establish CY
2019 as the performance period for the
PY 2021 ESRD QIP for all but the NHSN
Healthcare Personnel Influenza
Vaccination reporting measure because
it is consistent with the performance
periods we have historically used for
these measures and accounts for
seasonal variations that might affect a
facility’s measure score.
We are proposing that the
performance period for the NHSN
Healthcare Personnel Influenza
Vaccination reporting measure will be
from October 1, 2018 through March 31,
2019, because this period spans the
length of the 2018–2019 influenza
season.
We seek comments on these
proposals.
b. Performance Standards, Achievement
Thresholds, and Benchmarks for the
Clinical Measures Proposed for the PY
2021 ESRD QIP
At this time, we do not have the
necessary data to assign numerical
values to the proposed performance
standards for the clinical measures,
because we do not yet have data from
CY 2017 or the first portion of CY 2018.
We will publish values for the clinical
measures, using data from CY 2017 and
the first portion of CY 2018 in the CY
2019 ESRD PPS final rule.
6. Proposed Performance Standards,
Achievement Thresholds, and
Benchmarks for the PY 2021 ESRD QIP
Section 1881(h)(4)(A) of the Act
provides that ‘‘the Secretary shall
establish performance standards with
respect to measures selected . . . for a
performance period with respect to a
year.’’ Section 1881(h)(4)(B) of the Act
further provides that the ‘‘performance
standards . . . shall include levels of
achievement and improvement, as
determined appropriate by the
Secretary.’’ We use the performance
standards to establish the minimum
score a facility must achieve to avoid a
Medicare payment reduction.
a. Proposed Performance Standards,
Achievement Thresholds, and
Benchmarks for the Clinical Measures in
the PY 2021 ESRD QIP
For the same reasons stated in the CY
2013 ESRD PPS final rule (77 FR 67500
through 76502), we are proposing for PY
2021 to set the performance standards,
achievement thresholds, and
benchmarks for the clinical measures at
the 50th, 15th, and 90th percentile,
respectively, of national performance in
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c. Proposed Performance Standards for
the PY 2021 Reporting Measures
In the CY 2014 ESRD PPS final rule,
we finalized performance standards for
the Anemia Management and Mineral
Metabolism reporting measures (78 FR
72213). In the CY 2016 ESRD PPS final
rule, we finalized performance
standards for the Screening for Clinical
Depression and Follow-Up, Pain
Assessment and Follow-Up, and NHSN
Healthcare Provider Influenza
Vaccination reporting measures (79 FR
66209). In the CY 2017 ESRD PPS final
rule, we finalized performance
standards for the Ultrafiltration Rate
Reporting Measure (81 FR 77916), the
Serum Phosphorus Reporting measure
(81 FR 77916), and the NHSN Dialysis
Event Reporting measure (81 FR 77916).
We are proposing to continue use of
these performance standards for the
Reporting Measures included in the PY
2021 ESRD QIP.
7. Proposal for Scoring the PY 2021
ESRD QIP
a. Scoring Facility Performance on
Clinical Measures Based on
Achievement
In the CY 2014 ESRD PPS final rule,
we finalized a policy for scoring
performance on clinical measures based
on achievement (78 FR 72215). Under
this methodology, facilities receive
points along an achievement range
based on their performance during the
performance period for each measure,
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which we define as a scale between the
achievement threshold and the
benchmark. In determining a facility’s
achievement score for each clinical
measure under the PY 2021 ESRD QIP,
we propose to continue using this
methodology for all clinical measures.
We also propose to use this same
methodology for scoring the two new
Vascular Access measures proposed in
sections IV.E.4.a and IV.E.4.b.
Aside from the proposed addition of
the two Vascular Access measures, we
are not proposing any changes to this
policy. We propose to continue use of
this policy for the PY 2021 ESRD QIP.
b. Proposal for Scoring Facility
Performance on Clinical Measures
Based on Improvement
In the CY 2014 ESRD PPS final rule,
we finalized a policy for scoring
performance on clinical measures based
on improvement (78 FR 72215 through
72216). In determining a facility’s
improvement score for each measure
under the PY 2021 ESRD QIP, we
propose to continue using this
methodology for all clinical measures.
Under this methodology, facilities
receive points along an improvement
range, defined as a scale running
between the improvement threshold and
the benchmark. We propose to define
the improvement threshold as the
facility’s performance on the measure
during CY 2018. The facility’s
improvement score would be calculated
by comparing its performance on the
measure during CY 2019 (the proposed
performance period) to the
improvement threshold and benchmark.
We also propose to use this same
methodology for scoring the two new
Vascular Access measures proposed in
sections IV.E.4.a and IV.E.b.
Aside from the proposed addition of
the two new Vascular Access measures,
we are not proposing any changes to
this policy. We propose to continue use
of this policy for the PY 2021 ESRD QIP.
c. Scoring the ICH CAHPS Clinical
Measure
In the CY 2015 ESRD PPS final rule,
we finalized a policy for scoring
performance on the ICH CAHPS clinical
measure based on both achievement and
improvement (79 FR 66209 through
66210). We are proposing to use this
scoring methodology for the PY 2021
ESRD QIP. Under this methodology,
facilities will receive an achievement
score and an improvement score for
each of the three composite measures
and three global ratings in the ICH
CAHPS survey instrument. A facility’s
ICH CAHPS score will be based on the
higher of the facility’s achievement or
improvement score for each of the
composite measures and global ratings,
and the resulting scores on each of the
composite measures and global ratings
will be averaged together to yield an
overall score on the ICH CAHPS clinical
measure. For PY 2021, the facility’s
achievement score would be calculated
by comparing where its performance, on
each of the three composite measures
and three global ratings during CY 2019,
falls relative to the achievement
threshold and benchmark for that
measure and rating based on CY 2017
data. The facility’s improvement score
would be calculated by comparing its
performance on each of the three
composite measures and three global
ratings during CY 2019 to its
performance rates on these items during
CY 2018.
We seek comments on this proposal.
d. Proposal for Scoring the Proposed
Hemodialysis Vascular Access:
Standardized Fistula Rate and LongTerm Catheter Rate Measures and the
Vascular Access Measure Topic
In the CY 2013 ESRD PPS final rule
we established a methodology for
deriving the overall scores for measure
topics (77 FR 67507). We are proposing
to use the same methodology described
in the CY 2013 ESRD PPS to calculate
the VAT Measure Topic Score.
We seek comments on this proposal.
e. Proposal for Calculating Facility
Performance on Reporting Measures
In the CY 2013 ESRD PPS final rule,
we finalized policies for scoring
performance on the Anemia
Management and Mineral Metabolism
reporting measures in the ESRD QIP (77
FR 67506). In the CY 2015 ESRD PPS
final rule, we finalized policies for
scoring performance on the Clinical
Depression Screening and Follow-Up,
Pain Assessment and Follow-Up, and
NHSN Healthcare Provider Influenza
Vaccination reporting measures (79 FR
66210 through 66211). In the CY 2017
ESRD PPS final rule, we finalized
policies for scoring performance on the
Ultrafiltration Rate, Serum Phosphorus,
and NHSN Dialysis Event reporting
measures (81 FR 77917).
We propose to continue use of these
policies for the PY 2021 ESRD QIP.
8. Proposal for Weighting the Clinical
Measure Domain, and Weighting the
TPS
a. Proposal for Weighting the Clinical
Measure Domain for PY 2021
In the CY 2017 ESRD PPS final rule,
we discussed our policy priorities for
quality improvement for patients with
ESRD (81 FR 77887). These priorities
have not changed since that time.
Accordingly, in an effort to remain
consistent in the weighting of measures
included in the program, we propose to
weight the following measures in the
following subdomains of the clinical
measure domain (see Table 8):
TABLE 8—PROPOSED MEASURE DOMAIN WEIGHTING FOR THE PY 2021 ESRD QIP
Measure
weight within
the domain
(proposed for
PY 2021)
(%)
Measures/measure topics by subdomain
Measure
weight as
percent of
TPS
(proposed for
PY 2021)
sradovich on DSK3GMQ082PROD with PROPOSALS2
Clinical Measure Domain
Patient and Family Engagement/Care Coordination Subdomain ...........................................................................
ICH CAHPS Measure .......................................................................................................................................
SRR Measure ...................................................................................................................................................
Clinical Care Subdomain .........................................................................................................................................
STrR measure ..................................................................................................................................................
Kt/V Dialysis Adequacy Comprehensive Measure ...........................................................................................
Vascular Access Type Measure Topic .............................................................................................................
Hypercalcemia measure ...................................................................................................................................
SHR Measure ...................................................................................................................................................
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40
25
15
60
11
18
18
2
11
30
18.75
11.25
45
8.25
13.5
13.5
1.5
8.25
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TABLE 8—PROPOSED MEASURE DOMAIN WEIGHTING FOR THE PY 2021 ESRD QIP—Continued
Measure
weight within
the domain
(proposed for
PY 2021)
(%)
Measures/measure topics by subdomain
Total: Clinical Measure Domain .......................................................................................................................
Measure
weight as
percent of
TPS
(proposed for
PY 2021)
100% of
Clinical
Measure
Domain
75% of Total
Performance
Score.
Serum Phosphorus reporting measure ...................................................................................................................
Anemia Management reporting measure ................................................................................................................
Pain Assessment and Follow-Up reporting measure ..............................................................................................
Clinical Depression Screening and Follow-Up reporting measure .........................................................................
NHSN HCP Influenza Vaccination reporting measure ............................................................................................
20
20
20
20
20
2
2
2
2
2
Total: Reporting Measure Domain ...................................................................................................................
100% of
Reporting
Measure
Domain
10% of Total
Performance
Score.
NHSN BSI Clinical Measure ....................................................................................................................................
NHSN Dialysis Event Reporting Measure ...............................................................................................................
60
40
9
6
Total: Safety Measure Domain .........................................................................................................................
100% of
Safety
Measure
Domain
15% of Total
Performance
Score.
Reporting Measure Domain
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Safety Measure Domain
Specifically, for PY 2021 we are
proposing to maintain the weight of the
Safety Measure Domain at 15 percent of
a facility’s TPS without raising it
further, in light of validation concerns
discussed in the CY 2017 ESRD PPS
final rule (81 FR 77887). Specifically,
we identified two distinct types of
accidental or intentional underreporting. First, there is a belief that
many facilities do not consistently
report monthly dialysis event data for
the full 12-month performance period.
Second, even with respect to the
facilities that do report monthly dialysis
event data, there is a concern that many
of those facilities do not consistently
report all of the dialysis events that they
should be reporting (81 FR 77879).
Additionally, as discussed above,
although we are not proposing to change
the total number of measures in the
ESRD QIP’s measure set for PY 2021, we
are proposing to replace the existing
Vascular Access measures with the
proposed Standardized Fistula and
Catheter Clinical measures. We believe
these measures hold the same
importance and value as the measures
they are replacing and are therefore not
proposing any changes to the weights
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finalized for PY 2020 in the CY 2017
ESRD PPS final rule. We may, in future
years of the program, consider
increasing the weight of the NHSN BSI
Clinical Measure and/or the NHSN BSI
Measure Topic once we see that
facilities are completely and accurately
reporting to NHSN and once we have
analyzed the data from the recently
increased NHSN Data Validation Study.
We seek comments on these
proposals.
changes to this and are proposing to
apply it to the PY 2021 program year.
In the CY 2017 ESRD PPS final rule,
we finalized that, to be eligible to
receive a TPS, a facility must be eligible
to be scored on at least one measure in
the Clinical Measure Domain and at
least one measure in the Reporting
Measure Domain. We are not proposing
any changes to this policy for the PY
2021 ESRD QIP.
We seek comments on the continued
use of these policies.
b. Proposal for Weighting the Domains
Used To Calculate the TPS
9. Example of the Proposed PY 2021
ESRD QIP Scoring Methodology
We continue to believe that while the
reporting measures are valuable, the
clinical measures assess facility
performance on actual patient care
processes and outcomes and therefore
justify a higher combined weight (78 FR
72217). In the CY 2017 ESRD PPS final
rule, we finalized that the weight of the
Safety Measure Domain would be 15
percent of a facility’s TPS, the weight of
the Clinical Measure Domain would be
75 percent of a facility’s TPS and the
weight of the Reporting Measure
Domain would be 10 percent of a
facility’s TPS. We are not proposing any
In this section, we provide an
example to illustrate the proposed
scoring methodology for PY 2021.
Figures 1 through 4 illustrate how to
calculate the Clinical Measure Domain
score, the Reporting Measure Domain
score, the Safety Measure Domain score,
and the TPS. Figure 5 illustrates the full
proposed scoring methodology for PY
2021. Note that for this example,
Facility A, a hypothetical facility, has
performed very well.
Figure 1 illustrates the methodology
used to calculate the Clinical Measure
Domain score for Facility A.
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Reporting Measure Domain score for
Facility A.
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Figure 2 illustrates the general
methodology for calculating the
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Figure 3 illustrates the methodology
used for calculating the Safety Measure
Domain score for Facility A.
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Figure 4 illustrates the methodology
used to calculate the TPS for Facility A.
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Figure 5 illustrates the full scoring
methodology for PY 2021.
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Our policy is to score facilities on
clinical and reporting measures for
which they have a minimum number of
qualifying patients during the
performance period. With the exception
of the Standardized Readmission Ratio,
Standardized Hospitalization Ratio,
Standardized Transfusion Ratio, NHSN
Healthcare Personnel Influenza
Vaccination, and ICH CAHPS clinical
measures, a facility must treat at least 11
qualifying cases during the performance
period in order to be scored on a clinical
or reporting measure. A facility must
have at least 11 index discharges to be
eligible to receive a score on the SRR
clinical measure, 10 patient-years at risk
to be eligible to receive a score on the
STrR clinical measure, and 5 patientyears at risk to be eligible to receive a
score on the SHR clinical measure. The
NHSN Healthcare Personnel Influenza
Vaccination measure does not assess
patient level data and therefore does not
have a minimum qualifying patient
count. In order to receive a score on the
ICH CAHPS clinical measure, a facility
must have treated at least 30 surveyeligible patients during the eligibility
period and receive 30 completed
surveys during the performance period.
We propose to continue use of these
minimum data policies for the measures
that we have proposed to continue
including in the PY 2021 ESRD QIP
measure set. Additionally, we propose
to use these same minimum data
policies for the proposed Vascular
Access Measures discussed above.
Under our current policy, we begin
counting the number of months for
which a facility is open on the first day
of the month after the facility’s CMS
Certification Number (CCN) Open Date.
In section IV.D.1 of the preamble, we
proposed clarifications to our CCN
Open Date Policy and to the patient
minimum requirements for each of the
measures finalized for the PY 2020
ESRD QIP. For the PY 2021 ESRD QIP,
only facilities with a CCN Open Date
before July 1, 2019 would be eligible to
be scored on the Anemia Management,
Serum Phosphorous, Ultrafiltration
Rate, Pain Assessment and Follow-Up,
Clinical Depression Screening and
Follow-Up reporting measures, and only
facilities with a CCN Open Date before
January 1, 2019 would be eligible to be
scored on the NHSN BSI Clinical and
Reporting Measures, the ICH CAHPS
Clinical Measure, and the NHSN
Healthcare Personnel Influenza
Vaccination reporting measure. We
propose to continue applying these CCN
open date policies to the measures
proposed for PY 2021.
Table 9 displays the proposed patient
minimum requirements for each of the
measures, as well as the proposed CCN
Open Dates after which a facility would
not be eligible to receive a score on a
reporting measure. We note that the 11
qualifying patient minimum used for
the majority of the measures shown in
the table below is a long-standing policy
in the ERSD QIP.
TABLE 9—PROPOSED MINIMUM DATA REQUIREMENTS FOR THE PY 2021 ESRD QIP
Measure
Minimum data requirements
CCN open date
Dialysis Adequacy (Clinical) .......
11 qualifying patients ...........................................
N/A .....................................
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Small facility adjuster
11–25 qualifying patients.
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10. Proposed Minimum Data for Scoring
Measures for the PY 2021 ESRD QIP
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TABLE 9—PROPOSED MINIMUM DATA REQUIREMENTS FOR THE PY 2021 ESRD QIP—Continued
Measure
Minimum data requirements
CCN open date
Hemodialysis Vascular Access:
Standardized Fistula Rate
(Clinical).
Hemodialysis Vascular Access:
Standardized Catheter Rate
(Clinical).
Hypercalcemia (Clinical) .............
NHSN BSI (Clinical) ....................
NHSN Dialysis Event (Reporting)
SRR (Clinical) .............................
STrR (Clinical) .............................
SHR (Clinical) .............................
ICH CAHPS (Clinical) .................
11 qualifying patients ...........................................
N/A .....................................
11–25 qualifying patients.
11 qualifying patients ...........................................
N/A .....................................
11–25 qualifying patients.
11 qualifying patients ...........................................
* 11 qualifying patients .........................................
* 11 qualifying patients .........................................
11 index discharges .............................................
10 patient-years at risk ........................................
5 patient-years at risk ..........................................
Facilities with 30 or more survey-eligible patients
during the CY preceding the performance period must submit survey results. Facilities will
not receive a score if they do not obtain a total
of at least 30 completed surveys during the
performance period.
11 qualifying patients ...........................................
11 qualifying patients ...........................................
11 qualifying patients ...........................................
N/A .....................................
Before January 1, 2019 .....
Before January 1, 2019 .....
N/A .....................................
N/A .....................................
N/A .....................................
Before January 1, 2019 .....
11–25 qualifying patients.
11–25 qualifying patients.
N/A.
11–41 index discharges.
10–21 patient-years at risk.
5–14 patient-years at risk.
N/A.
Before July 1, 2019 ............
Before July 1, 2019 ............
Before July 1, 2019 ............
N/A.
N/A.
N/A.
11 qualifying patients ...........................................
Before July 1, 2019 ............
N/A.
N/A .......................................................................
Before January 1, 2019 .....
N/A.
11 qualifying patients ...........................................
Before July 1, 2019 ............
N/A.
Anemia Management (Reporting)
Serum Phosphorus (Reporting) ..
Depression Screening and Follow-Up (Reporting).
Pain Assessment and Follow-Up
(Reporting).
NHSN Healthcare Personnel Influenza Vaccination (Reporting).
Ultrafiltration Rate (Reporting) ....
Small facility adjuster
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* For the NHSN BSI Clinical Measure and the NHSN Dialysis Event Reporting Measure, qualifying patients include only in-center hemodialysis
patients. Inpatient hemodialysis patients and home hemodialysis or peritoneal dialysis patients are excluded from this measure.
11. Proposed Payment Reductions for
the PY 2021 ESRD QIP
Section 1881(h)(3)(A)(ii) of the Act
requires the Secretary to ensure that the
application of the scoring methodology
results in an appropriate distribution of
payment reductions across facilities,
such that facilities achieving the lowest
TPSs receive the largest payment
reductions. We propose that, for the PY
2021 ESRD QIP, a facility will not
receive a payment reduction if it
achieves a minimum TPS that is equal
to or greater than the total of the points
it would have received if:
• It performed at the performance
standard for each clinical measure.
• It received the number of points for
each reporting measure that corresponds
to the 50th percentile of facility
performance on each of the PY 2019
reporting measures. We note this
proposed policy for PY 2021 is identical
to the policy finalized for PY 2020.
We recognize that we are not
proposing a policy regarding the
inclusion of measures for which we are
not able to establish a numerical value
for the performance standard through
the rulemaking process before the
beginning of the performance period in
the PY 2020 minimum TPS. We have
not proposed such a policy because no
measures in the proposed PY 2021
measure set meet this criterion.
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However, should we choose to adopt a
clinical measure in future rulemaking
without the baseline data required to
calculate a performance standard before
the beginning of the performance
period, we will propose a criterion
accounting for that measure in the
minimum TPS for the applicable
payment year at that time.
The PY 2019 program is the most
recent year for which we will have
calculated final measure scores before
the beginning of the proposed
performance period for PY 2021 (that is,
CY 2019). Because we have not yet
calculated final measure scores, we are
unable to determine the 50th percentile
of facility performance on the PY 2019
reporting measures. We will publish
that value once we have calculated final
measure scores for the PY 2019
program.
Section 1881(h)(3)(A)(ii) of the Act
requires that facilities achieving the
lowest TPSs receive the largest payment
reductions. In the CY 2014 ESRD PPS
final rule (78 FR 72223 through 72224),
we finalized a payment reduction scale
for PY 2016 and future payment years:
For every 10 points a facility falls below
the minimum TPS, the facility would
receive an additional 0.5 percent
reduction on its ESRD PPS payments for
PY 2016 and future payment years, with
a maximum reduction of 2.0 percent.
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We are not proposing any changes to
this policy for the PY 2021 ESRD QIP.
Because we are not yet able to
calculate the performance standards for
each of the clinical measures, we are
also not able to calculate a proposed
minimum TPS at this time. We will
propose a minimum TPS, based on data
from CY 2017 and the first part of CY
2018, in the CY 2019 ESRD PPS
proposed rule.
We are not proposing any changes to
these policies.
V. Advancing Health Information
Exchange
HHS has a number of initiatives
designed to improve health and health
care quality through the adoption of
health information technology (health
IT) and nationwide health information
exchange. Health IT facilitates the
secure, efficient, and effective sharing
and use of health-related information
when and where it is needed, and is an
important tool for settings across the
continuum of care, including ESRD
facilities. Health IT plays an important
role in developing care plans to manage
dialysis related care and co-morbid
conditions for patients with ESRD, as
well as enabling electronic coordination
and communication among
multidisciplinary teams. Such tools can
promote quality improvement, improve
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efficiencies and reduce unnecessary
costs.
HHS continues to make important
strides promoting the availability of
technology tools to support providers,
including those in ESRD settings. For
instance, the Office of the National
Coordinator for Health Information
Technology (ONC) released a document
entitled ‘‘Connecting Health and Care
for the Nation: A Shared Nationwide
Interoperability Roadmap Version 1.0
(Roadmap) (available at https://
www.healthit.gov/sites/default/files/hieinteroperability/nationwideinteroperability-roadmap-final-version1.0.pdf), which describes barriers to
interoperability across the current
health IT landscape, the desired future
state that the industry believes will be
necessary to enable a learning health
system, and a suggested path for moving
from the current state to the desired
future state. In the near term, the
Roadmap focuses on actions that will
enable a majority of individuals and
providers across the care continuum to
send, receive, find and use a common
set of electronic clinical information at
the nationwide level by the end of 2017.
Moreover, the vision described in the
Roadmap significantly expands the
types of electronic health information,
information sources, and information
users well beyond clinical information
derived from electronic health records.
In addition, ONC has released the
2017 Interoperability Standards
Advisory (available at https://
www.healthit.gov/standards-advisory), a
coordinated catalog of standards and
implementation specifications to enable
priority health information exchange
functions. Providers, payers, and
vendors are encouraged to take these
health IT standards into account as they
implement interoperable health
information exchange across the
continuum of care.
We encourage stakeholders to utilize
health information exchange and
certified health IT to effectively and
efficiently help providers improve
internal care delivery practices, support
management of care across the
continuum, enable the reporting of
electronically specified clinical quality
measures, and improve efficiencies and
reduce unnecessary costs. As adoption
of certified health IT increases and
interoperability standards continue to
mature, HHS will seek to reinforce
standards through relevant policies and
programs.
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VI. Collection of Information
Requirements
A. Legislative Requirement for
Solicitation of Comments
Under the Paperwork Reduction Act
of 1995, we are required to provide 60day notice in the Federal Register and
solicit public comment before a
collection of information requirement is
submitted to the Office of Management
and Budget (OMB) for review and
approval. In order to fairly evaluate
whether an information collection
requirement should be approved by
OMB, section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995
requires that we solicit comment on the
following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
B. Requirements in Regulation Text
We are not proposing any changes to
the regulatory text for the ESRD PPS or
for AKI dialysis payment in CY 2018.
C. Additional Information Collection
Requirements
31223
and coordinating care for patients.12
The mean hourly wage of a Medical
Records and Health Information
Technician is $19.93 per hour. Fringe
benefit is calculated at 100 percent.
Therefore, using these assumptions, we
estimate an hourly labor cost of $39.86
as the basis of the wage estimates for all
collection of information calculations in
the ESRD QIP. We have adjusted these
employee hourly wage estimates by a
factor of 100 percent to reflect current
HHS department-wide guidance on
estimating the cost of fringe benefits and
overhead. These are necessarily rough
adjustments, both because fringe
benefits and overhead costs vary
significantly from employer to employer
and because methods of estimating
these costs vary widely from study to
study. Nonetheless, there is no practical
alternative and we believe that these are
reasonable estimation methods.
b. Time Required To Submit Data Based
on Proposed Reporting Requirements
In the CY 2016 ESRD PPS final rule
(80 FR 69070), we estimated that the
time required to submit measure data
using CROWNWeb is 2.5 minutes per
data element submitted, which takes
into account the small percentage of
data that is manually reported, as well
as the human interventions required to
modify batch submission files such that
they meet CROWNWeb’s internal data
validation requirements.
To derive wage estimates, we used
data from the U.S. Bureau of Labor
Statistics’ May 2016 National
Occupational Employment and Wage
Estimates. In the CY 2016 ESRD PPS
final rule (80 FR 69069), we stated that
it was reasonable to assume that
Medical Records and Health
Information Technicians, who are
responsible for organizing and managing
health information data,11 are the
individuals tasked with submitting
measure data to CROWNWeb and NHSN
for purposes of the Data Validation
Studies rather than a Registered Nurse,
whose duties are centered on providing
c. Data Validation Requirements for the
PY 2020 ESRD QIP
Section IV.D.7 of this proposed rule
outlines our data validation proposals
for PY 2020. Specifically, for the
CROWNWeb validation, we propose to
continue randomly sampling records
from 300 facilities as part of our
continuing pilot data-validation
program. Each sampled facility would
be required to produce approximately
10 records, and the sampled facilities
will be reimbursed by our validation
contractor for the costs associated with
copying and mailing the requested
records. The burden associated with
these validation requirements is the
time and effort necessary to submit the
requested records to a CMS contractor.
We estimate that it will take each
facility approximately 2.5 hours to
comply with this requirement. If 300
facilities are asked to submit records, we
estimate that the total combined annual
burden for these facilities will be 750
hours (300 facilities × 2.5 hours). Since
we anticipate that Medical Records and
Health Information Technicians or
11 https://www.bls.gov/oes/current/
oes292071.htm.
12 https://www.bls.gov/oes/current/
oes291141.htm.
This proposed rule does not impose
any new information collection
requirements in the regulation text, as
specified above. However, there are
changes in some currently approved
information collections. The following
is a discussion of these information
collections.
1. ESRD QIP
a. Wage Estimates
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similar administrative staff would
submit this data, we estimate that the
aggregate cost of the CROWNWeb data
validation would be approximately
$29,895 (750 hours × $39.86/hour), or a
total of approximately $93 ($29,895/300
facilities) per facility in the sample. The
burden associated with these
requirements is captured in an
information collection request (OMB
control number 0938–1289).
Under the proposed continued data
validation study for validating data
reported to the NHSN Dialysis Event
Module, we are proposing to continue
using the methodology finalized in the
CY 2017 ESRD PPS final rule, however
we have proposed a modification to our
sampling methodology (81 FR 77956). A
CMS contractor would send these
facilities requests for medical records
for all patients with ‘‘candidate events’’
during the evaluation period. Overall,
we estimate that, on average, quarterly
lists would include two positive blood
cultures per facility, but we recognize
these estimates may vary considerably
from facility to facility. We estimate that
it would take each facility
approximately 60 minutes to comply
with this requirement (30 minutes from
each of the two quarters in the
evaluation period). If 35 facilities are
asked to submit records, we estimate
that the total combined annual burden
for these facilities would be 35 hours
(35 facilities × 1 hour). Since we
anticipate that Medical Records and
Health Information Technicians or
similar administrative staff would
submit this data, we estimate that the
aggregate cost of the NHSN data
validation would be $1,395.10 (35 hours
× $39.86/hour), or a total of $39.86
($1,395.10/35 facilities) per facility in
the sample. The burden associated with
these requirements is captured in an
information collection request (OMB
control number 0938–NEW).
To determine the burden associated
with new collection of information
requirements, we look at each of these
elements together: The total number of
patients nationally, the number of
elements per patient-year required for
each measure, the amount of time
required for data entry, and the
estimated wage plus benefits of the
individuals within facilities who are
most likely to be entering data into
CROWNWeb. Therefore, based on this
methodology, in the CY 2017 ESRD PPS
final rule, we anticipated the burden
associated with the new collection of
information requirements was
approximately $91 million for the PY
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2020 ESRD QIP (81 FR 77957).13 We are
not changing our data collection
methodology for PY 2021; however, we
are proposing to replace two existing
measures for PY 2021. We believe
replacing the two existing measures
would have a de minimis effect on the
overall burden associated with
collection of information requirements
in PY 2021. Accordingly, the PY 2021
burden estimate remains the same at
$91 million. The net incremental
burden from PY 2020 to PY 2021 is $0.
VII. Request for Information on
Medicare Flexibilities and Efficiencies
CMS is committed to transforming the
health care delivery system—and the
Medicare program—by putting an
additional focus on patient-centered
care and working with providers,
physicians, and patients to improve
outcomes. We seek to reduce burdens
for hospitals, physicians, and patients,
improve the quality of care, decrease
costs, and ensure that patients and their
providers and physicians are making the
best health care choices possible. These
are the reasons we are including this
Request for Information in this proposed
rule.
As we work to maintain flexibility
and efficiency throughout the Medicare
program, we would like to start a
national conversation about
improvements that can be made to the
health care delivery system that reduce
unnecessary burdens for clinicians,
other providers, and patients and their
families. We aim to increase quality of
care, lower costs, improve program
integrity, and make the health care
system more effective, simple and
accessible.
We would like to take this
opportunity to invite the public to
submit their ideas for regulatory,
subregulatory, policy, practice, and
procedural changes to better accomplish
these goals. Ideas could include
payment system redesign, elimination
or streamlining of reporting, monitoring
and documentation requirements,
aligning Medicare requirements and
processes with those from Medicaid and
other payers, operational flexibility,
feedback mechanisms and data sharing
that would enhance patient care,
support of the physician-patient
relationship in care delivery, and
13 We note that the aggregate impact of the PY
2020 ESRD QIP was included in the CY 2017 ESRD
PPS final rule (81 FR 77834 through 77969). The
previously finalized aggregate impact of $113
million reflects the PY 2020 estimated payment
reductions and the collection of information
requirements for the Ultrafiltration Rate Reporting
Measure, finalized in the CY 2017 ESRD PPS final
rule (81 FR 77915).
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facilitation of individual preferences.
Responses to this Request for
Information could also include
recommendations regarding when and
how CMS issues regulations and
policies and how CMS can simplify
rules and policies for beneficiaries,
clinicians, physicians, providers, and
suppliers. Where practicable, data and
specific examples would be helpful. If
the proposals involve novel legal
questions, analysis regarding CMS’
authority is welcome for CMS’
consideration. We are particularly
interested in ideas for incentivizing
organizations and the full range of
relevant professionals and
paraprofessionals to provide screening,
assessment and evidence-based
treatment for individuals with opioid
use disorder and other substance use
disorders, including reimbursement
methodologies, care coordination,
systems and services integration, use of
paraprofessionals including community
paramedics and other strategies. We are
requesting commenters to provide clear
and concise proposals that include data
and specific examples that could be
implemented within the law.
We note that this is a Request for
Information only. Respondents are
encouraged to provide complete but
concise responses. This Request for
Information is issued solely for
information and planning purposes; it
does not constitute a Request for
Proposal (RFP), applications, proposal
abstracts, or quotations. This Request for
Information does not commit the United
States Government to contract for any
supplies or services or make a grant
award.
Further, CMS is not seeking proposals
through this Request for Information
and will not accept unsolicited
proposals. Responders are advised that
the United States Government will not
pay for any information or
administrative costs incurred in
response to this Request for Information;
all costs associated with responding to
this Request for Information will be
solely at the interested party’s expense.
We note that not responding to this
Request for Information does not
preclude participation in any future
procurement, if conducted. It is the
responsibility of the potential
responders to monitor this Request for
Information announcement for
additional information pertaining to this
request. In addition, we note that CMS
will not respond to questions about the
policy issues raised in this Request for
Information. CMS will not respond to
comment submissions in response to
this Request for Information in the CY
2018 ESRD PPS final rule. Rather, CMS
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A. Regulatory Impact Analysis
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Section 3(f) of Executive Order
12866 defines a ‘‘significant regulatory
action’’ as an action that is likely to
result in a rule: (1) Having an annual
effect on the economy of $100 million
or more in any 1 year, or adversely and
materially affecting a sector of the
economy, productivity, competition,
jobs, the environment, public health or
safety, or state, local or tribal
governments or communities (also
referred to as economically significant);
(2) creating a serious inconsistency or
otherwise interfering with an action
taken or planned by another agency; (3)
materially altering the budgetary
impacts of entitlement grants, user fees,
or loan programs or the rights and
obligations of recipients thereof; or (4)
raising novel legal or policy issues
arising out of legal mandates, the
President’s priorities, or the principles
set forth in the Executive Order.
A regulatory impact analysis (RIA)
must be prepared for major rules with
economically significant effects ($100
million or more in any 1 year). This rule
is economically significant within the
meaning of section 3(f)(1) of the
Executive Order, since it meets the $100
million threshold. Additionally, OMB
has determined that the actions are
significant within the meaning of
section 3(f)(4) of the Executive Order.
Therefore, OMB has reviewed these
proposed regulations, and the
Departments have provided the
following assessment of their impact.
We solicit comments on the regulatory
impact analysis provided.
1. Introduction
We have examined the impacts of this
rule as required by Executive Order
12866 on Regulatory Planning and
Review (September 30, 1993), Executive
Order 13563 on Improving Regulation
and Regulatory Review (January 18,
2011), the Regulatory Flexibility Act
(RFA) (September 19, 1980, Pub. L. 96–
354), section 1102(b) of the Social
Security Act, section 202 of the
Unfunded Mandates Reform Act of 1995
(March 22, 1995; Pub. L. 104–4),
Executive Order 13132 on Federalism
(August 4, 1999), the Congressional
Review Act (5 U.S.C. 804(2)), and
Executive Order 13771 on Reducing
Regulation and Controlling Regulatory
Costs (January 30, 2017).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
2. Statement of Need
This rule proposes a number of
routine updates and one policy change
to the ESRD PPS in CY 2018. The
proposed routine updates include the
CY 2018 wage index values, the wage
index budget-neutrality adjustment
factor, and outlier payment threshold
amounts. The proposed policy change
involves an update to the outlier pricing
policy. Failure to publish this proposed
rule would result in ESRD facilities not
receiving appropriate payments in CY
2018 for renal dialysis services
furnished to ESRD patients.
This rule proposes routine updates to
the payment for renal dialysis services
furnished by ESRD facilities to
individuals with AKI. Failure to publish
this proposed rule would result in ESRD
facilities not receiving appropriate
payments in CY 2018 for renal dialysis
will actively consider all input as we
develop future regulatory proposals or
future subregulatory policy guidance.
CMS may or may not choose to contact
individual responders. Such
communications would be for the sole
purpose of clarifying statements in the
responders’ written responses.
Contractor support personnel may be
used to review responses to this Request
for Information. Responses to this notice
are not offers and cannot be accepted by
the Government to form a binding
contract or issue a grant. Information
obtained as a result of this Request for
Information may be used by the
Government for program planning on a
nonattribution basis. Respondents
should not include any information that
might be considered proprietary or
confidential. This Request for
Information should not be construed as
a commitment or authorization to incur
cost for which reimbursement would be
required or sought. All submissions
become United States Government
property and will not be returned. CMS
may publicly post the public comments
received, or a summary of those public
comments.
VIII. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
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IX. Economic Analyses
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31225
services furnished to patients with AKI
in accordance with section 1834(r) of
the Act.
This rule proposes to implement
requirements for the ESRD QIP,
including a proposal to adopt a measure
set for the PY 2021 program, as directed
by section 1881(h) of the Act. Failure to
propose requirements for the PY 2021
ESRD QIP would prevent continuation
of the ESRD QIP beyond PY 2020. In
addition, proposing requirements for the
PY 2021 ESRD QIP provides facilities
with more time to review and fully
understand new measures before their
implementation in the ESRD QIP.
3. Overall Impact
We estimate that the proposed
revisions to the ESRD PPS will result in
an increase of approximately $100
million in payments to ESRD facilities
in CY 2018, which includes the amount
associated with updates to the outlier
thresholds, outlier policy, and updates
to the wage index. We are estimating
approximately $2 million that would
now be paid to ESRD facilities for
dialysis treatments provided to AKI
beneficiaries.
For PY 2021, we estimate that the
proposed revisions to the ESRD QIP will
result in a savings of $29 million, which
includes a zero incremental burden due
to collection of information
requirements and $29 million in
estimated payment reductions across all
facilities.
If regulations impose administrative
costs on private entities, such as the
time needed to read and interpret this
proposed rule, we should estimate the
cost associated with regulatory review.
Due to the uncertainty involved with
accurately quantifying the number of
entities that will review the rule, we
assume that the total number of unique
commenters on last year’s proposed rule
will be the number of reviewers of this
proposed rule. We acknowledge that
this assumption may understate or
overstate the costs of reviewing this
rule. It is possible that not all
commenters reviewed last year’s rule in
detail, and it is also possible that some
reviewers chose not to comment on the
proposed rule. For these reasons we
thought that the number of past
commenters would be a fair estimate of
the number of reviewers of this rule. We
welcome any comments on the
approach in estimating the number of
entities which will review this proposed
rule.
We also recognize that different types
of entities are in many cases affected by
mutually exclusive sections of this
proposed rule, and therefore for the
purposes of our estimate we assume that
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each reviewer reads approximately 50
percent of the rule. We seek comments
on this assumption.
Using the wage information from the
BLS (https://www.bls.gov/oes/2015/
may/naics4_621100.htm) for medical
and health service managers (Code 11–
9111), we estimate that the cost of
reviewing this rule is $105.00 per hour,
including overhead and fringe benefits.
Assuming an average reading speed, we
estimate that it would take
approximately 1.25 hours for the staff to
review half of this proposed rule. For
each ESRD facility that reviews the rule,
the estimated cost is $131.25 (1.25 hours
× $105.00). Therefore, we estimate that
the total cost of reviewing this
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regulation is $19,162.50 ($131.25 × 146
reviewers).
B. Detailed Economic Analysis
1. CY 2018 End-Stage Renal Disease
Prospective Payment System
a. Effects on ESRD Facilities
To understand the impact of the
changes affecting payments to different
categories of ESRD facilities, it is
necessary to compare estimated
payments in CY 2017 to estimated
payments in CY 2018. To estimate the
impact among various types of ESRD
facilities, it is imperative that the
estimates of payments in CY 2017 and
CY 2018 contain similar inputs.
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Therefore, we simulated payments only
for those ESRD facilities for which we
are able to calculate both current
payments and new payments.
For this proposed rule, we used CY
2016 data from the Part A and B
Common Working Files, as of February
17, 2017, as a basis for Medicare dialysis
treatments and payments under the
ESRD PPS. We updated the 2016 claims
to 2017 and 2018 using various updates.
The updates to the ESRD PPS base rate
are described in section II.B.2.d of this
proposed rule. Table 10 shows the
impact of the estimated CY 2018 ESRD
payments compared to estimated
payments to ESRD facilities in CY 2017.
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Table 10- Impact of Proposed Changes in Payment to ESRD Facilities for CY 2018
P ropose dRue
I
Number of
Facilities
A
Facility Type
All Facilities
6,754
....
Typ~
..
Number of
Treatments (in
millions)
B
.·
••••
Freestanding
Effect of 2018
Changes in
payment rate
update
E
Effect of
Total2018
Proposed
Changes
F
0.1%
0.0%
0.7%
0.8%
c
44.3
.·· ·.·
Effect of 2018
Changes in
Wage Indices
and Wage Floor
D
Effect of 2018
Changes in
Outlier Policy
.•·
.. •
6,325
Hospital based
41.9
0.1%
0.0%
0.7%
0.8%
429
2.4
0.2%
0.1%
0.7%
1.0%
0.0%
0.7%
0.8%
.
Ownership 'J'ype
Large dialysis organization
> .
5,001
33.3
.
.·
...
0.1%
Regional chain
881
5.9
0.1%
0.1%
0.7%
1.0%
Independent
502
3.2
0.1%
0.0%
0.7%
0.8%
Hospital based 1
368
2.0
0.2%
0.1%
0.7%
1.1%
2
0.0
0.1%
-0.8%
0.7%
-0.1%
Unknown
.. · ....
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outlier payment policy described in
section II.B.2.c of this proposed rule is
shown in column C. For CY 2018, the
impact on all ESRD facilities as a result
of the changes to the outlier payment
policy would be a 0.1 percent increase
in estimated payments. Nearly all ESRD
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facilities are anticipated to experience a
positive effect in their estimated CY
2018 payments as a result of the
proposed outlier policy changes.
Column D shows the effect of the
proposed CY 2018 wage indices and the
wage index floor of 0.4000. The
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1
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categories of types of facilities in the
impact table show changes in estimated
payments ranging from a 0.8 percent
decrease to a 0.3 percent increase due to
these proposed updates in the wage
indices.
Column E shows the effect of the
proposed CY 2018 ESRD PPS payment
rate update. The proposed ESRD PPS
payment rate update is 0.7 percent,
which reflects the proposed ESRDB
market basket percentage increase factor
for CY 2018 of 2.2 percent, the 1.0
percent reduction as required by the
section 1881(b)(14)(F)(i)(I) of the Act,
and the MFP adjustment of 0.5 percent.
Column F reflects the overall impact,
that is, the effects of the proposed
outlier policy changes, the proposed
wage index floor, and payment rate
update. We expect that overall ESRD
facilities would experience a 0.8 percent
increase in estimated payments in CY
2018. The categories of types of facilities
in the impact table show impacts
ranging from a decrease of 0.1 percent
to an increase of 1.2 percent in their CY
2018 estimated payments.
b. Effects on Other Providers
Under the ESRD PPS, Medicare pays
ESRD facilities a single bundled
payment for renal dialysis services,
which may have been separately paid to
other providers (for example,
laboratories, durable medical equipment
suppliers, and pharmacies) by Medicare
prior to the implementation of the ESRD
PPS. Therefore, in CY 2018, we estimate
that the proposed ESRD PPS would
have zero impact on these other
providers.
c. Effects on the Medicare Program
We estimate that Medicare spending
(total Medicare program payments) for
ESRD facilities in CY 2018 would be
approximately $10.0 billion. This
estimate takes into account a projected
increase in fee-for-service Medicare
dialysis beneficiary enrollment of 1.8
percent in CY 2018.
sradovich on DSK3GMQ082PROD with PROPOSALS2
d. Effects on Medicare Beneficiaries
Under the ESRD PPS, beneficiaries are
responsible for paying 20 percent of the
ESRD PPS payment amount. As a result
of the projected 0.8 percent overall
increase in the proposed CY 2018 ESRD
PPS payment amounts, we estimate that
there will be an increase in beneficiary
co-insurance payments of 0.8 percent in
CY 2018, which translates to
approximately $20 million. The $20
million is based on 20 percent of CY
2018 estimated total payment increase
of $100 million.
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e. Alternatives Considered
In section II.B.2.b of this proposed
rule, we propose maintaining the wage
index floor at 0.4000. We considered
increasing the wage index floor to
0.5000 as well as increasing the wage
index floor to 0.6000 and determined
that maintaining the wage index floor at
0.4000 provided the appropriate
adjustment related to the cost of
furnishing dialysis in areas with a wage
index less than 0.4000.
2. Proposed Payment for Renal Dialysis
Services Furnished to Individuals With
AKI
a. Effects on ESRD Facilities
We analyzed CY 2016 hospital
outpatient claims to identify the number
of treatments furnished historically for
AKI patients. We identified 8,900
outpatient treatments with AKI that also
had dialysis treatments that were
furnished in CY 2016. We then inflated
the 8,900 treatments to 2018 values
using estimated population growth for
fee-for service non-ESRD beneficiaries.
This results in an estimated 9,170
treatments that would now be paid to
ESRD facilities for furnishing dialysis to
beneficiaries with AKI. Using the
proposed CY 2018 ESRD base rate of
$233.31 and an average wage index
multiplier, we are estimating
approximately $2 million that would
now be paid to ESRD facilities for
dialysis treatments provided to AKI
beneficiaries.
Ordinarily, we would provide a table
showing the impact of this provision on
various categories of ESRD facilities.
Because we have no way to project how
many patients with AKI requiring
dialysis will choose to have dialysis
treatments at an ESRD facility, we are
unable to provide a table at this time.
b. Effects on Other Providers
Under section 1834(r) of the Act, as
added by section 808(b) of TPEA, we are
proposing to update the payment rate
for renal dialysis services furnished by
ESRD facilities to beneficiaries with
AKI. The only two Medicare providers
authorized to provide these outpatient
renal dialysis services are hospital
outpatient departments and ESRD
facilities. The decision about where the
renal dialysis services are furnished is
made by the patient and his or her
physician. Therefore, this proposal will
have zero impact on other Medicare
providers.
c. Effects on the Medicare Program
We estimate approximately $2 million
would be paid to ESRD facilities in CY
2018 as a result of AKI patients
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receiving renal dialysis services in the
ESRD facility at the lower ESRD PPS
base rate versus receiving those services
only in the hospital outpatient setting.
d. Effects on Medicare Beneficiaries
Currently, beneficiaries have a 20
percent co-insurance obligation when
they receive AKI dialysis in the hospital
outpatient setting. When these services
are furnished in an ESRD facility, the
patients would continue to be
responsible for a 20 percent coinsurance. Because the AKI dialysis
payment rate paid to ESRD facilities is
lower than the outpatient prospective
payment system’s payment amount, we
would expect beneficiaries to pay less
co-insurance when AKI dialysis is
furnished by ESRD facilities.
e. Alternatives Considered
As we discussed in the CY 2017 ESRD
PPS proposed rule (81 FR 42870), we
considered adjusting the AKI payment
rate by including the ESRD PPS casemix adjustments, and other adjustments
at section 1881(b)(14)(D) of the Act, as
well as not paying separately for AKI
specific drugs and laboratory tests. We
ultimately determined that treatment for
AKI is substantially different from
treatment for ESRD and the case-mix
adjustments applied to ESRD patients
may not be applicable to AKI patients
and as such, including those policies
and adjustment would be inappropriate.
We will monitor utilization and trends
of items and services furnished to
individuals with AKI for purposes of
refining the payment rate in the future.
This monitoring will assist us in
developing knowledgeable, data-driven
proposals.
3. ESRD QIP
a. Effects of the PY 2021 ESRD QIP on
ESRD Facilities
The ESRD QIP provisions are
intended to prevent possible reductions
in the quality of ESRD dialysis facility
services provided to beneficiaries as a
result of payment changes under the
ESRD PPS. The methodology that we are
proposing to use to determine a
facility’s TPS for the PY 2021 ESRD QIP
is described in section IV.E.8 of this
proposed rule. Any reductions in ESRD
PPS payments as a result of a facility’s
performance under the PY 2021 ESRD
QIP would apply to ESRD PPS
payments made to the facility in CY
2021.
For the PY 2021 ESRD QIP, we
estimate that, of the 6,453 dialysis
facilities (including those not receiving
a TPS) enrolled in Medicare,
approximately 40 percent or 2,551 of the
facilities would receive a payment
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reduction in PY 2021. The total
payment reduction for all of the 2,551
facilities expected to receive a reduction
is approximately $29 million
($29,017,218). Facilities that do not
receive a TPS are not eligible for a
payment reduction.
Table 11 shows the overall estimated
distribution of payment reductions
resulting from the PY 2021 ESRD QIP.
To estimate whether or not a facility
TABLE 11—ESTIMATED DISTRIBUTION
OF PY 2021 ESRD QIP PAYMENT would receive a payment reduction in
PY 2021, we scored each facility on
REDUCTIONS
Payment
reduction
(%)
0.0
0.5
1.0
1.5
2.0
Number of
facilities
.............
.............
.............
.............
.............
Percent of
facilities
3,469
1,507
754
228
62
57.6
25.0
12.5
3.8
1.0
achievement and improvement on
several measures we have previously
finalized and for which there were
available data from CROWNWeb and
Medicare claims. Measures used for the
simulation are shown in Table 12.
Note: This table excludes 433 facilities that
we estimate will not receive a payment reduction because they will not report enough data
to receive a TPS.
TABLE 12—DATA USED TO ESTIMATE PY 2021 ESRD QIP PAYMENT REDUCTIONS
Period of time used to calculate achievement thresholds,
performance standards, benchmarks,
and improvement thresholds
Measure
VAT:
Standardized Fistula Ratio .............................................
% Catheter .....................................................................
Kt/V Dialysis Adequacy Comprehensive ...............................
Hypercalcemia .......................................................................
STrR ......................................................................................
ICH CAHPS Survey ..............................................................
SRR .......................................................................................
NHSN BSI .............................................................................
SHR .......................................................................................
sradovich on DSK3GMQ082PROD with PROPOSALS2
For all measures except STrR and
SHR, clinical measure topic areas with
less than 11 cases for a facility were not
included in that facility’s TPS. For SHR
and STrR, facilities were required to
have at least 5 and 10 patient-years at
risk, respectively, in order to be
included in the facility’s TPS. Each
facility’s TPS was compared to an
estimated minimum TPS and an
estimated payment reduction table that
were consistent with the proposals
outlined in section IV.E.8 of this
proposed rule. Facility reporting
measure scores were estimated using
available data from CY 2014 and 2015.
Facilities were required to have a score
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Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
2014–Dec
2014–Dec
2014–Dec
2014–Dec
2014–Dec
2015–Dec
2014–Dec
2014–Dec
2014–Dec
2014
2014
2014
2014
2014
2015
2014
2014
2014
............................................................
............................................................
............................................................
............................................................
............................................................
............................................................
............................................................
............................................................
............................................................
on at least one clinical and one
reporting measure to receive a TPS.
To estimate the total payment
reductions in PY 2021 for each facility
resulting from this proposed rule, we
multiplied the total Medicare payments
to the facility during the 1-year period
between January 2015 and December
2015 by the facility’s estimated payment
reduction percentage expected under
the ESRD QIP, yielding a total payment
reduction amount for each facility: Total
ESRD payment in January 2015 through
December 2015 times the estimated
payment reduction percentage.
Table 13 shows the estimated impact
of the finalized ESRD QIP payment
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Performance period
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
2015–Dec
2015–Dec
2015–Dec
2015–Dec
2014–Dec
2015–Dec
2015–Dec
2015–Dec
2015–Dec
2015.
2015.
2015.
2015.
2014.
2015.
2015.
2015.
2015.
reductions to all ESRD facilities for PY
2021. The table details the distribution
of ESRD facilities by facility size (both
among facilities considered to be small
entities and by number of treatments per
facility), geography (both urban/rural
and by region), and by facility type
(hospital based/freestanding facilities).
Given that the time periods used for
these calculations will differ from those
we propose to use for the PY 2021 ESRD
QIP, the actual impact of the PY 2021
ESRD QIP may vary significantly from
the values provided here.
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TABLE 13:
Im~act
of Pro~osed QIP Pa~ment Reductions to ESRD Facilities for PY 2021
Number of
Facilities
All Facilities
Number of
Treatments 2015 (in
millions)
Number of
Facilities with QIP
Score
Number ofFacilities
Expected to Receive a
Payment Reduction
Payment Reduction (percent
change in total ESRD
payments)
6,453
40.0
6,020
2,551
-0.32%
6,022
37.8
5,852
2,502
-0.33%
431
2.2
168
49
-0.20%
4,541
28.6
4,432
1,910
-0.32%
Regional Chain
989
6.2
929
316
-0.26%
Independent
568
3.5
536
282
-0.50%
Hospital-based
(non-chain)
354
-0.25%
Facility Type:
Freestanding
Hospital-based
Ownership Type:
Large Dialysis
1.8
123
43
0.0
Unknown
0
0
Facility Size:
Large Entities
5,530
34.8
5,361
2,226
-0.31%
Small Entitie/
922
5.2
659
325
-0.45%
0.0
0
0
Unknown
Rural Status:
1) Yes
1,260
6.0
1,146
325
-0.19%
2)No
5,193
34.0
4,874
2,226
-0.35%
879
6.2
786
340
-0.32%
Midwest
1,511
7.6
1,356
557
-0.31%
South
2,852
18.2
2,743
1,276
-0.36%
West
1,142
7.6
1,084
341
-0.22%
69
0.4
51
37
-0.56%
0.0
0
0
Census Region:
Northeast
US Territories"
Census Division:
Unknown
1,045
5.5
951
443
-0.36%
East South
Central
522
3.0
515
202
-0.30%
Middle Atlantic
702
4.9
623
300
-0.37%
Mountain
368
2.0
336
86
-0.17%
New England
182
1.3
164
40
-0.14%
Pacific
782
5.7
753
257
-0.24%
1,458
9.4
1,388
719
-0.41%
West North
Central
469
2.1
406
115
-0.19%
West South
Central
875
5.8
841
355
-0.33%
sradovich on DSK3GMQ082PROD with PROPOSALS2
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d. Effects on Medicare Beneficiaries
b. Effects on Other Providers
The ESRD QIP is applicable to
outpatient dialysis facilities. Therefore,
this proposal will have zero impact on
other Medicare providers. We are aware
that several of our measures do impact
other providers. For example, with the
introduction of the Standardized
Readmission Ratio Clinical measure in
PY 2017 and the Standardized
Hospitalization Ratio Clinical Measure
in PY 2020, we anticipate that hospitals
may experience financial savings as
dialysis facilities work to reduce the
number of unplanned readmissions and
hospitalizations. We are actively
exploring various methods to assess the
impact these measures have on
hospitals and other outpatient facilities.
c. Effects on the Medicare Program
For PY 2021, we estimate that ESRD
QIP will contribute approximately $29
million ($29,017,218) in Medicare
savings. For comparison, Table 14
shows the payment reductions achieved
by the ESRD QIP program for PYs 2016
through 2021.
The ESRD QIP is applicable to
outpatient dialysis facilities. Since the
program’s inception, there is evidence
of improved performance on ESRD QIP
measures. As we stated in the CY 2017
ESRD PPS final rule, one objective
measure we can examine to demonstrate
the improved quality of care over time
is the improvement of performance
standards (81 FR 77873). As the ESRD
QIP has refined its measure set and as
facilities have gained experience with
the measures included in the program,
performance standards have generally
continued to rise. We view this as
evidence that facility performance (and
therefore the quality of care provided to
Medicare beneficiaries) is objectively
improving. To date we have been unable
to examine the impact of the ESRD QIP
on Medicare beneficiaries including the
financial impact of the program or the
impact on the health outcomes of
beneficiaries. However, in future years
we are interested in examining these
impacts through the addition of new
measures to the program and through
the analysis of available data from our
existing measures.
TABLE 14—PAYMENT REDUCTIONS
PAYMENT YEAR 2016 THROUGH e. Alternatives Considered
2021
In an effort to reduce administrative
sradovich on DSK3GMQ082PROD with PROPOSALS2
Payment
year
PY
PY
PY
PY
PY
PY
2021
2020
2019
2018
2017
2016
...
...
...
...
...
...
VerDate Sep<11>2014
Estimated payment reductions
(citation)
$29,017,218.
$31,581,441 (81
$15,470,309 (80
$11,576,214 (79
$11,954,631 (79
$15,137,161 (78
18:27 Jul 03, 2017
FR
FR
FR
FR
FR
77960).
69074).
66257).
66255).
72247).
Jkt 241001
and financial burden on dialysis
facilities, we considered the burden
associated with each of the measures
included in the ESRD QIP to determine
whether any of the measures could
feasibly be removed from the program at
this time. The Ultrafiltration Rate
Reporting measure, finalized for
inclusion in the program beginning with
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PY 2020, adds a significant burden to
facilities because of the number of data
elements required to be entered for each
patient treated by the facility. We
carefully considered whether this
measure could be removed from the
program in an effort to reduce burden
for facilities, but as we noted in the CY
2017 ESRD PPS final rule, this measure
is extremely valuable from a clinical
perspective. Studies suggest that higher
ultrafiltration rates are associated with
higher mortality and higher odds of an
‘‘unstable’’ dialysis session, and that
rapid rates of fluid removal at dialysis
can precipitate events such as
intradialytic hypotension, subclinical,
yet significantly decreased organ
perfusion, and in some cases myocardial
damage and heart failure (81 FR 77912).
Therefore we continue to believe that,
despite the high burden associated with
this measure, it is clinically valuable
and important to continue including
this measure in the ESRD QIP’s measure
set and that the clinical benefits
outweigh the burden associated with the
measure.
C. Accounting Statement
As required by OMB Circular A–4
(available at https://
www.whitehouse.gov/omb/circulars_
a004_a-4), in Table 15 below, we have
prepared an accounting statement
showing the classification of the
transfers and costs associated with the
various provisions of this proposed rule.
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TABLE 15—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED TRANSFERS AND COSTS/SAVINGS
Category
Transfers
ESRD PPS and AKI
Annualized Monetized Transfers ..............................................................
From Whom to Whom ..............................................................................
Increased Beneficiary Co-insurance Payments .......................................
From Whom to Whom ..............................................................................
$80 million.
Federal government to ESRD providers.
$20 million.
Beneficiaries to ESRD providers.
ESRD QIP for PY 2021
Annualized Monetized Transfers ..............................................................
From Whom to Whom ..............................................................................
$¥29 million.
Federal government to ESRD providers (payment reductions).
Category
Costs
Annualized Monetized ESRD Provider Costs ..........................................
In accordance with the provisions of
Executive Order 12866, this proposed
rule was reviewed by the Office of
Management and Budget.
sradovich on DSK3GMQ082PROD with PROPOSALS2
X. Regulatory Flexibility Act Analysis
The Regulatory Flexibility Act
(September 19, 1980, Pub. L. 96–354)
(RFA) requires agencies to analyze
options for regulatory relief of small
entities, if a rule has a significant impact
on a substantial number of small
entities. For purposes of the RFA, small
entities include small businesses,
nonprofit organizations, and small
governmental jurisdictions.
Approximately 13 percent of ESRD
dialysis facilities are considered small
entities according to the Small Business
Administration’s (SBA) size standards,
which classifies small businesses as
those dialysis facilities having total
revenues of less than $38.5 million in
any 1 year. Individuals and States are
not included in the definitions of a
small entity. For more information on
SBA’s size standards, see the Small
Business Administration’s Web site at
https://www.sba.gov/content/smallbusiness-size-standards (Kidney
Dialysis Centers are listed as 621492
with a size standard of $38.5 million).
We do not believe ESRD facilities are
operated by small government entities
such as counties or towns with
populations of 50,000 or less, and
therefore, they are not enumerated or
included in this estimated RFA analysis.
Individuals and States are not included
in the definition of a small entity.
For purposes of the RFA, we estimate
that approximately 13 percent of ESRD
facilities are small entities as that term
is used in the RFA (which includes
small businesses, nonprofit
organizations, and small governmental
jurisdictions). This amount is based on
the number of ESRD facilities shown in
the ownership category in Table 10.
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18:27 Jul 03, 2017
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$0.
Using the definitions in this ownership
category, we consider the 502 facilities
that are independent and the 368
facilities that are shown as hospitalbased to be small entities. The ESRD
facilities that are owned and operated
by Large Dialysis Organizations (LDOs)
and regional chains would have total
revenues of more than $38.5 million in
any year when the total revenues for all
locations are combined for each
business (individual LDO or regional
chain), and are not, therefore, included
as small entities.
For the ESRD PPS updates proposed
in this rule, a hospital-based ESRD
facility (as defined by type of
ownership, not by type of dialysis
facility) is estimated to receive a 1.1
percent increase in payments for CY
2018. An independent facility (as
defined by ownership type) is also
estimated to receive a 0.8 percent
increase in payments for CY 2018.
For AKI dialysis, we are unable to
estimate whether patients will go to
ESRD facilities, however, we have
estimated there is a potential for $2.0
million in payment for AKI dialysis
treatments that could potentially be
furnished in ESRD facilities.
We estimate that of the 2,551 ESRD
facilities expected to receive a payment
reduction in the PY 2021 ESRD QIP, 325
are ESRD small entity facilities. We
present these findings in Table 11
(‘‘Estimated Distribution of PY 2021
ESRD QIP Payment Reductions’’) and
Table 13 (‘‘Impact of Proposed QIP
Payment Reductions to ESRD Facilities
for PY 2021’’) above. We estimate that
the payment reductions will average
approximately $11,375 per facility
across the 2,551 facilities receiving a
payment reduction, and $13,885 for
each small entity facility. Using our
estimates of facility performance, we
also estimated the impact of payment
reductions on ESRD small entity
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facilities by comparing the total
estimated payment reductions for 922
small entity facilities with the aggregate
ESRD payments to all small entity
facilities. We estimate that there are a
total of 922 small entity facilities, and
that the aggregate ESRD PPS payments
to these facilities would decrease 0.45
percent in PY 2021.
Therefore, the Secretary has
determined that this proposed rule
would not have a significant economic
impact on a substantial number of small
entities. The economic impact
assessment is based on estimated
Medicare payments (revenues) and
HHS’s practice in interpreting the RFA
is to consider effects economically
‘‘significant’’ only if greater than 5
percent of providers reach a threshold of
3 to 5 percent or more of total revenue
or total costs. We solicit comment on
the RFA analysis provided.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis if a rule may have a
significant impact on the operations of
a substantial number of small rural
hospitals. Any such regulatory impact
analysis must conform to the provisions
of section 603 of the RFA. For purposes
of section 1102(b) of the Act, we define
a small rural hospital as a hospital that
is located outside of a metropolitan
statistical area and has fewer than 100
beds. We do not believe this proposed
rule will have a significant impact on
operations of a substantial number of
small rural hospitals because most
dialysis facilities are freestanding.
While there are 132 rural hospital-based
dialysis facilities, we do not know how
many of them are based at hospitals
with fewer than 100 beds. However,
overall, the 132 rural hospital-based
dialysis facilities will experience an
estimated 0.7 percent decrease in
payments. As a result, this proposed
rule is not estimated to have a
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significant impact on small rural
hospitals.
Therefore, the Secretary has
determined that this proposed rule
would not have a significant impact on
the operations of a substantial number
of small rural hospitals.
XI. Unfunded Mandates Reform Act
Analysis
sradovich on DSK3GMQ082PROD with PROPOSALS2
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
also requires that agencies assess
anticipated costs and benefits before
issuing any rule whose mandates
require spending in any 1 year of $100
million in 1995 dollars, updated
annually for inflation. In 2017, that is
approximately $148 million. This
proposed rule does not include any
mandates that would impose spending
costs on State, local, or Tribal
governments in the aggregate, or by the
private sector, of $141 million.
Moreover, HHS interprets UMRA as
applying only to unfunded mandates.
We do not interpret Medicare payment
rules as being unfunded mandates, but
simply as conditions for the receipt of
payments from the federal government
for providing services that meet federal
standards. This interpretation applies
whether the facilities or providers are
private, State, local, or Tribal.
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XII. Federalism Analysis
Executive Order 13132 on Federalism
(August 4, 1999) establishes certain
requirements that an agency must meet
when it promulgates a proposed rule
(and subsequent final rule) that imposes
substantial direct requirement costs on
State and local governments, preempts
State law, or otherwise has Federalism
implications. We have reviewed this
proposed rule under the threshold
criteria of Executive Order 13132,
Federalism, and have determined that it
will not have substantial direct effects
on the rights, roles, and responsibilities
of States, local or Tribal governments.
XIII. Reducing Regulation and
Controlling Regulatory Costs
Executive Order 13771, entitled
Reducing Regulation and Controlling
Regulatory Costs (82 FR 9339), was
issued on January 30, 2017. This
proposed rule is not expected to be
subject to the requirements of E.O.
13771 because, if finalized as proposed,
it is expected to result in no more than
de minimis costs.
XIV. Congressional Review Act
This proposed rule is subject to the
Congressional Review Act provisions of
the Small Business Regulatory
Enforcement Fairness Act of 1996 (5
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31233
U.S.C. 801 et seq.) and has been
transmitted to the Congress and the
Comptroller General for review.
XV. Files Available to the Public via the
Internet
The Addenda for the annual ESRD
PPS proposed and final rulemakings
will no longer appear in the Federal
Register. Instead, the Addenda will be
available only through the Internet and
is posted on the CMS Web site at https://
www.cms.gov/ESRDPayment/PAY/
list.asp In addition to the Addenda,
limited data set (LDS) files are available
for purchase at https://www.cms.gov/
Research-Statistics-Data-and-Systems/
Files-for-Order/LimitedDataSets/
EndStageRenalDiseaseSystemFile.html.
Readers who experience any problems
accessing the Addenda or LDS files,
should contact ESRDPayment@
cms.hhs.gov.
Dated: June 27, 2017.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: June 27, 2017.
Thomas E. Price,
Secretary, Department of Health and Human
Services.
[FR Doc. 2017–13908 Filed 6–29–17; 4:15 pm]
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Agencies
[Federal Register Volume 82, Number 127 (Wednesday, July 5, 2017)]
[Proposed Rules]
[Pages 31190-31233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13908]
[[Page 31189]]
Vol. 82
Wednesday,
No. 127
July 5, 2017
Part III
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 413 and 414
Medicare Program; End-Stage Renal Disease Prospective Payment System,
Payment for Renal Dialysis Services Furnished to Individuals With Acute
Kidney Injury, and End-Stage Renal Disease Quality Incentive Program;
Proposed Rule
Federal Register / Vol. 82 , No. 127 / Wednesday, July 5, 2017 /
Proposed Rules
[[Page 31190]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 413 and 414
[CMS-1674-P]
RIN 0938-AT04
Medicare Program; End-Stage Renal Disease Prospective Payment
System, Payment for Renal Dialysis Services Furnished to Individuals
With Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive
Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This rule proposes to update and make revisions to the End-
Stage Renal Disease (ESRD) Prospective Payment System (PPS) for
calendar year (CY) 2018, as well as to update the payment rate for
renal dialysis services furnished by an ESRD facility to individuals
with acute kidney injury (AKI). This rule also proposes to set forth
requirements for the ESRD Quality Incentive Program (QIP), including
for payment years (PYs) 2019 through 2021.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. August 28, 2017.
ADDRESSES: In commenting, please refer to file code CMS-1674-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. 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-1674-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-1674-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments ONLY to the following addresses prior to
the close of the comment period:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1810.
If you intend to deliver your comments to the Baltimore address,
call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: ESRDPayment@cms.hhs.gov, for issues
related to the ESRD PPS and coverage and payment for renal dialysis
services furnished to individuals with AKI.
Delia Houseal, (410) 786-2724, for issues related to the ESRD QIP.
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 Web
site as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
Electronic Access
This Federal Register document is also available from the Federal
Register online database through Federal Digital System (FDsys), a
service of the U.S. Government Printing Office. This database can be
accessed via the internet at https://www.gpo.gov/fdsys/.
Table of Contents
To assist readers in referencing sections contained in this
preamble, we are providing a Table of Contents. Some of the issues
discussed in this preamble affect the payment policies, but do not
require changes to the regulations in the Code of Federal Regulations
(CFR).
I. Executive Summary
A. Purpose
1. End-Stage Renal Disease (ESRD) Prospective Payment System
(PPS)
2. Coverage and Payment for Renal Dialysis Services Furnished to
Individuals With Acute Kidney Injury (AKI)
3. End-Stage Renal Disease (ESRD) Quality Incentive Program
(QIP)
B. Summary of the Major Provisions
1. ESRD PPS
2. Payment for Renal Dialysis Services Furnished to Individuals
With AKI
3. ESRD QIP
C. Summary of Cost and Benefits
1. Impacts of the Proposed ESRD PPS
2. Impact of the Proposed Payment for Renal Dialysis Services
Furnished to Individuals With AKI
3. Impacts of the Proposed ESRD QIP
II. Calendar Year (CY) 2018 End-Stage Renal Disease (ESRD)
Prospective Payment System (PPS)
A. Background
1. Statutory Background
2. System for Payment of Renal Dialysis Services
3. Updates to the ESRD PPS
B. Provisions of the Proposed Rule
1. Pricing Eligible Outlier Drugs and Biologicals That Were or
Would Have Been, Prior to January 1, 2011, Separately Billable Under
Medicare Part B
a. Summary of Outlier Calculation
b. Use of ASP Methodology Under the ESRD PPS
c. Pricing Methodologies Under Section 1847A of the Act
d. Proposal for Pricing Eligible Outlier Drugs and Biologicals
That Were or Would Have Been, Prior to January 1, 2011, Separately
Billable Under Medicare Part B
2. Proposed CY 2018 ESRD PPS Update
a. ESRD Bundled Market Basket
i. Proposed CY 2018 ESRD Market Basket Update, Productivity
Adjustment, and Labor-Related Share for ESRD PPS
ii. Proposed CY 2018 ESRDB Market Basket Update, Adjusted for
Multifactor Productivity (MFP)
[[Page 31191]]
b. The Proposed CY 2018 ESRD PPS Wage Indices
i. Annual Update of the Wage Index
ii. Application of the Wage Index Under the ESRD PPS
c. CY 2018 Update to the Outlier Policy
i. CY 2018 Update to the Outlier Services MAP Amounts and FDL
Amounts
ii. Outlier Percentage
d. Proposed Impacts to the CY 2018 ESRD PPS Base Rate
i. ESRD PPS Base Rate
ii. Annual Payment Rate Update for CY 2018
III. CY 2018 Payment for Renal Dialysis Services Furnished to
Individuals With Acute Kidney Injury (AKI)
A. Background
B. Annual Payment Rate Update for CY 2018
1. CY 2018 AKI Dialysis Payment Rate
2. Geographic Adjustment Factor
IV. End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP)
for Payment Year (PY) 2021
A. Background
B. Accounting for Social Risk Factors in the ESRD QIP Program
C. Proposed Change to the Performance Score Certificate
Beginning With the Payment Year (PY) 2019 ESRD QIP
D. Proposed Requirements Beginning With the PY 2020 ESRD QIP
1. Proposal To Clarify the Minimum Data Policy for Scoring
Measures Finalized for the PY 2020 ESRD QIP
2. Proposed Changes to the Extraordinary Circumstances Exception
(ECE) Policy
3. Solicitation of Comments on the Inclusion of Acute Kidney
Injury (AKI) Patients in the ESRD QIP
4. Estimated Performance Standards, Achievement Thresholds, and
Benchmarks for the Clinical Measures Finalized for the PY 2020 ESRD
QIP
5. Policy for Weighting the Clinical Measure Domain for PY 2020
6. Proposed Payment Reductions for the PY 2020 ESRD QIP
7. Data Validation
E. Proposed Requirements for the PY 2021 ESRD QIP
1. Proposed Measures for the PY 2021 ESRD QIP
2. Proposed Replacement of the Vascular Access Type (VAT)
Clinical Measures Beginning With the PY 2021 Program Year
3. Proposed Revision of the Standardized Transfusion Ratio
(STrR) Clinical Measure Beginning With the PY 2021 Program Year
4. Proposed New Vascular Access Measures Beginning With the PY
2021 ESRD QIP
a. Proposed New Hemodialysis Vascular Access: Standardized
Fistula Rate Clinical Measure (NQF #2977)
b. Proposed New Hemodialysis Vascular Access: Long-Term Catheter
Rate (NQF #2978) Beginning With the PY 2021 ESRD QIP
5. Proposed Performance Period for the PY 2021 ESRD QIP
6. Proposed Performance Standards, Achievement Thresholds, and
Benchmarks for the PY 2021 ESRD QIP
a. Proposed Performance Standards, Achievement Thresholds, and
Benchmarks for the Clinical Measures in the PY 2021 ESRD QIP
b. Performance Standards, Achievement Thresholds, and Benchmarks
for the Clinical Measures Proposed for the PY 2021 ESRD QIP
c. Proposed Performance Standards for the PY 2021 Reporting
Measures
7. Proposal for Scoring the PY 2021 ESRD QIP
a. Scoring Facility Performance on Clinical Measures Based on
Achievement
b. Proposal for Scoring Facility Performance on Clinical
Measures Based on Improvement
c. Scoring the ICH CAHPS Clinical Measure
d. Proposal for Scoring the Proposed Hemodialysis Vascular
Access: Standardized Fistula Rate and Long-Term Catheter Rate
Measures and the Vascular Access Measure Topic
e. Proposal for Calculating Facility Performance on Reporting
Measures
8. Proposal for Weighting the Clinical Measure Domain, and
Weighting the TPS
a. Proposal for Weighting the Clinical Measure Domain for PY
2021
b. Proposal for Weighting the Domains Used To Calculate the TPS
9. Example of the Proposed PY 2021 ESRD QIP Scoring Methodology
10. Proposed Minimum Data for Scoring Measures for the PY 2021
ESRD QIP
11. Proposed Payment Reductions for the PY 2021 ESRD QIP
V. Advancing Health Information Exchange
VI. Collection of Information Requirements
A. Legislative Requirement for the Solicitation of Comments
B. Requirements in Regulation Text
C. Additional Information Collection Requirements
1. ESRD QIP
a. Wage Estimates
b. Time Required To Submit Data Based on Proposed Reporting
Requirements
c. Data Validation Requirements for the PY 2020 ESRD QIP
VII. Request for Information on Medicare Flexibilities and
Efficiencies
VIII. Response to Comments
IX. Economic Analyses
A. Regulatory Impact Analysis
1. Introduction
2. Statement of Need
3. Overall Impact
B. Detailed Economic Analysis
1. CY 2018 End-Stage Renal Disease Prospective Payment System
a. Effects on ESRD Facilities
b. Effects on Other Providers
c. Effects on the Medicare Program
d. Effects on Medicare Beneficiaries
e. Alternatives Considered
2. Proposed Payment for Renal Dialysis Services Furnished to
Individuals With AKI
a. Effects on ESRD Facilities
b. Effects on Other Providers
c. Effects on the Medicare Program
d. Effects on Medicare Beneficiaries
e. Alternatives Considered
3. ESRD QIP
a. Effects of the PY 2021 ESRD QIP on ESRD Facilities
b. Effects on Other Providers
c. Effects on the Medicare Program
d. Effects on Medicare Beneficiaries
e. Alternatives Considered
C. Accounting Statement
X. Regulatory Flexibility Act Analysis
XI. Unfunded Mandates Reform Act Analysis
XII. Federalism Analysis
XIII. Reducing Regulation and Controlling Regulatory Costs
XIV. Congressional Review Act
XV. Files Available to the Public via the Internet
Acronyms
Because of the many terms to which we refer by acronym in this
proposed rule, we are listing the acronyms used and their corresponding
meanings in alphabetical order below:
Affordable Care Act the Patient Protection and Affordable Care Act
ABLE Stephen Beck, Jr., Achieving a Better Life Experience Act of
2014
AKI Acute Kidney Injury
AMP Average Manufacturer Price
ASP Average Sales Price
ATRA American Taxpayer Relief Act of 2012
BLS Bureau of Labor Statistics
BSI Bloodstream Infection
CBSA Core Based Statistical Area
CCN CMS Certification Number
CDC Centers for Disease Control and Prevention
CEO Chief Executive Officer
CFR Code of Federal Regulations
CMS Centers for Medicare & Medicaid Services
CROWNWeb Consolidated Renal Operations in a Web-Enabled Network
CY Calendar Year
DFR Dialysis Facility Report
ECE Extraordinary Circumstances Exception
EPO Epoetin
ESA Erythropoiesis stimulating agent
ESRD End-Stage Renal Disease
ESRDB End-Stage Renal Disease Bundled
ESRD PPS End-Stage Renal Disease Prospective Payment System
ESRD QIP End-Stage Renal Disease Quality Incentive Program
FFS Fee-For-Service
FDA Food and Drug Administration
FDL Fixed-Dollar Loss
ICD International Classification of Diseases
ICH CAHPS In-Center Hemodialysis Consumer Assessment of Healthcare
Providers and Systems
IGI IHS Global Inc.
IPPS Inpatient Prospective Payment System
IQR Interquartile Range
Kt/V A measure of dialysis adequacy where K is dialyzer clearance, t
is dialysis time, and V is total body water volume
MAP Medicare Allowable Payment
MFP Multifactor Productivity
MIPPA Medicare Improvements for Patients and Providers Act of 2008
(Pub. L. 110-275)
NHSN National Healthcare Safety Network
NQF National Quality Forum
[[Page 31192]]
OMB Office of Management and Budget
PAMA Protecting Access to Medicare Act of 2014
PPS Prospective Payment System
PY Payment Year
QIP Quality Incentive Program
RFA Regulatory Flexibility Act
SBA Small Business Administration
SHR Standardized Hospitalization Ratio
SRR Standardized Readmission Ratio
STrR Standardized Transfusion Ratio
TCV Truncated Coefficient of Variation
TDAPA Transitional Drug Add-on Payment Adjustment
TEP Technical Expert Panel
The Act Social Security Act
The Secretary Secretary of the Department of Health and Human
Services
TPEA Trade Preferences Extension Act of 2015
TPS Total Performance Score
VAT Vascular Access Type
WAMP Widely Available Market Price
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
prospective payment system for renal dialysis services furnished by
ESRD facilities. This rule proposes to update and make revisions to the
ESRD PPS for calendar year (CY) 2018. 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), and 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 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.
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 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 AKI. Section 808(b) of
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.
3. End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP)
This rule also proposes to set forth requirements for the end-stage
renal disease (ESRD) quality incentive program (QIP), including for
payment years (PYs) 2019, 2020, and 2021. The program is authorized
under section 1881(h) of the Social Security Act (the Act). The ESRD
QIP is the most recent step in fostering improved patient outcomes by
establishing incentives for dialysis facilities to meet or exceed
performance standards established by the Centers for Medicare &
Medicaid Services (CMS).
B. Summary of the Major Provisions
1. ESRD PPS
Update to the ESRD PPS base rate for CY 2018: The proposed
CY 2018 ESRD PPS base rate is $233.31. This amount reflects a reduced
market basket increase as required by section 1881(b)(14)(F)(i)(I) of
the Act (0.7 percent), and application of the wage index budget-
neutrality adjustment factor (1.000605), equaling $233.31 ($231.55 x
1.007 x 1.000605 = $233.31).
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 2018, we are not proposing any changes to the application of the
wage index floor and we propose to continue to apply the current wage
index floor (0.4000) to areas with wage index values below the floor.
Update to the outlier policy: Consistent with our proposal
to annually update the outlier policy using the most current data, we
are proposing to 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 2018 using CY
2016 claims data. Based on the use of more current data, the FDL amount
for pediatric beneficiaries would decrease from $68.49 to $49.55 and
the MAP amount would decrease from $38.29 to $38.25, as compared to CY
2017 values. For adult beneficiaries, the FDL amount would increase
from $82.92 to $83.12 and the MAP amount would decrease from $45.00 to
$42.70. The 1 percent target for outlier payments was not achieved in
CY 2016. Outlier payments represented approximately 0.78 percent of
total payments rather than 1.0 percent. We believe using CY 2016 claims
data to update the outlier MAP and FDL amounts for CY 2018 would
increase payments for ESRD beneficiaries requiring higher resource
utilization in accordance with a 1 percent outlier percentage.
Update to the pricing of drugs and biologicals under the
outlier policy: We are proposing a change to the ESRD PPS outlier
policy to allow the use of any pricing methodology available under
section 1847A of the Act to determine the cost of certain eligible
outlier service drugs and biologicals in computing outlier payments
when average sales price (ASP) data is not available.
2. Payment for Renal Dialysis Services Furnished to Individuals With
AKI
We are proposing to update the AKI payment rate for CY 2018. The
proposed CY 2018 payment rate is $233.31, which is the same base rate
proposed under the ESRD PPS.
3. ESRD QIP
This rule proposes to set forth requirements for the ESRD QIP,
including for payment years (PYs) 2019, 2020 and 2021 as follows:
Updating the Performance Score Certificate Beginning in PY
2019: In section IV.C of this proposed rule, we set forth the updates
we are proposing to make to the Performance Score Certificate (PSC)
beginning in PY 2019. Specifically, in response to feedback from
stakeholders about the length and complexity of the PSC, and in an
effort to make the document more effective and understandable for the
community, we propose to shorten and simplify the PSC. Specifically, we
are proposing to shorten the PSC by removing some of the information we
had previously finalized would be included in the document. We are
proposing that the revised PSC would indicate the facility's TPS, as
required under section 1881(h)(6)(c) of the Act, as well as information
sufficient to identify the facility and information showing how the
facility's TPS compared to the national average TPS for that specific
payment year. We are not making any proposals to change the other
requirements associated with this document. Facilities would still be
required to post their PSC in a public
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location in both English and Spanish (77 FR 67517).
Proposed Changes to the Extraordinary Circumstances
Exception (ECE) Policy: In section IV.D.2 of this proposed rule, we set
forth the updates we are proposing to the Extraordinary Circumstances
Exception (ECE) Policy for the ESRD QIP. In an effort to bring our
policy into alignment with other quality reporting and value based
purchasing programs, we are proposing to (1) allow facilities to submit
a form signed by the facility's CEO or designated personnel; (2) expand
the reasons for which an ECE can be requested by a facility or granted
by CMS of its own accord to include an unresolved issue with a CMS data
system, which affected the ability of the facility to submit data (an
unresolved data system issue, in this case, would be one which did not
allow the facility to submit data by the data submission deadline and
one which was unable to be resolved with a work-around); and (3)
specify that a facility does not need to be closed in order to request
and receive consideration for an ECE, as long as the facility can
demonstrate that its normal operations have been significantly affected
by an extraordinary circumstance outside of its control. We are also
clarifying that our intent is to notify a facility of our decision on a
facility's ECE request within 90 days of the date that we receive it.
Proposed PY 2021 Measure Set: As discussed in section
IV.E.1 of this proposed rule, in the CY 2017 ESRD PPS final rule (81 FR
77834 through 77969), we previously finalized 16 measures to be
included in the PY 2020 ESRD QIP. For PY 2021, we are proposing to
update the Standardized Transfusion Ratio (STrR) Clinical Measure to
bring the measure into alignment with the National Quality Forum (NQF)-
endorsed specifications, and replace the two existing Vascular Access
Type (VAT) measures with newly endorsed vascular access measures that
address long-held concerns of the community. Specifically, we are
proposing to replace the VAT measures with the Proposed Hemodialysis
Vascular Access: Standardized Fistula Rate Clinical Measure and the
Proposed Hemodialysis Vascular Access: Long-Term Catheter Rate Clinical
Measure. There would be no increase in burden associated with the
proposed measure changes.
Data Validation: In section IV.D.7 of this proposed rule,
we set forth the updates we are proposing to make to the data
validation program in the ESRD QIP. For PY 2020, we are proposing to
continue the pilot validation study for validation of Consolidated
Renal Operations in a Web-Enabled Network (CROWNWeb) data. Under this
continued validation study, we are proposing to continue using the same
methodology used for the PY 2018 and PY 2019 ESRD QIP. Under this
methodology, we would sample approximately 10 records per facility from
300 facilities during CY 2018.
For PY 2020, we are proposing to continue a National Healthcare
Safety Network (NHSN) Bloodstream Infection (BSI) Data Validation study
similar to the one that we finalized in the CY 2017 ESRD PPS final
rule. Under that methodology, we would select 35 facilities to
participate in an NHSN dialysis event validation study for two quarters
of data reported in CY 2018. The CMS data validation contractor would
then send these facilities requests for medical records for all
patients with ``candidate events'' during the evaluation period, as
well as randomly selected patient records. Each facility selected would
be required to submit 10 records total to the CMS validation
contractor. The CMS contractor would utilize a methodology for
reviewing and validating the candidate events that is consistent with
the Centers for Disease Control and Prevention's (CDC's) validation
protocol, and analyze those records to determine whether the facility
reported dialysis events for those patients in accordance with the NHSN
Dialysis Event Protocol. Information from the validation study would be
used to develop a methodology to score facilities based on the accuracy
of their reporting of the NHSN BSI Clinical Measure.
C. Summary of Costs and Benefits
In section IX 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 chart in section IX of this proposed rule displays the
estimated change in payments to ESRD facilities in CY 2018 compared to
estimated payments in CY 2017. The overall impact of the CY 2018
changes is projected to be a 0.8 percent increase in payments.
Hospital-based ESRD facilities have an estimated 1.0 percent increase
in payments compared with freestanding facilities with an estimated 0.8
percent increase.
We estimate that the aggregate ESRD PPS expenditures would increase
by approximately $100 million from CY 2017 to CY 2018. This reflects a
$90 million increase from the payment rate update and a $10 million
increase due to the updates to the outlier threshold amounts. As a
result of the projected 0.8 percent overall payment increase, we
estimate that there would be an increase in beneficiary co-insurance
payments of 0.8 percent in CY 2018, which translates to approximately
$20 million.
2. Impacts of the Proposed Payment for Renal Dialysis Services
Furnished to Individuals With AKI
We anticipate an estimated $2.0 million would be paid to ESRD
facilities in CY 2018 as a result of AKI patients receiving renal
dialysis services in the ESRD facility at the ESRD PPS base rate versus
receiving those services in the hospital outpatient setting.
3. Impacts of the Proposed ESRD QIP
We estimate that the overall economic impact of the ESRD QIP would
be approximately $113 million in PY 2020 and $113 million in PY 2021.
The $113 million figure for PY 2020 includes costs associated with the
collection of information requirements, which we estimate would be
approximately $91 million.\1\ For PY 2021, we estimate that ESRD
facilities would experience an aggregate impact of approximately $120
million as a result of the PY 2021 ESRD QIP. For PY 2021, these
estimates have not significantly changed because we are not proposing
to add any new measures to the program which would require an increased
burden associated with the collection of information requirements. We
are proposing to replace two existing measures but no new burdens are
being proposed. Similarly, we are not proposing to increase the size of
either of the Data Validation Studies proposed for PY 2020 so
facilities would not experience an increase in burden with respect to
being selected to participate in either of those two studies.
Therefore, the overall economic impact of the ESRD QIP would be similar
in PY 2021 to what it was in PY 2020.
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\1\ We note that the aggregate impact of the PY 2020 ESRD QIP
was included in the CY 2017 ESRD PPS Final Rule (81 FR 77957). The
previously finalized aggregate impact of $113 million reflects the
PY 2020 estimated payment reductions and the collection of
information requirements finalized in the PY 2020 ESRD QIP Final
Rule.
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The ESRD QIP would continue to incentivize facilities to provide
high-quality care to beneficiaries.
[[Page 31194]]
II. Calendar Year (CY) 2018 End-Stage Renal Disease (ESRD) Prospective
Payment System (PPS)
A. Background
1. Statutory Background
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 with 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.
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. And 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 CYs 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 42 CFR 413.171,
which is in subpart H of 42 CFR part 413. Our other payment policies
are also included in regulations in subpart H of 42 CFR part 413. 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, four co-morbidity
categories, and pediatric patient-level adjusters consisting of two age
categories and two dialysis modalities (42 CFR 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 (42 CFR 413.232). The second adjustment
reflects differences in area wage levels developed from Core Based
Statistical Areas (CBSAs) (42 CFR 413.231). The third payment
adjustment accounts for ESRD facilities furnishing renal dialysis
services in a rural area (42 CFR 413.233).
The ESRD PPS allows for a training add-on for home and self-
dialysis modalities (42 CFR 413.235(c)) and an additional payment for
high cost outliers due to unusual variations in the type or amount of
medically necessary care when applicable (42 CFR 413.237).
The ESRD PPS also provides for a transitional drug add-on payment
adjustment (TDAPA) to pay for a new injectable or intravenous product
that is not considered included in the ESRD PPS base rate, meaning a
product that is used to treat or manage a condition for which there is
not an existing ESRD PPS functional category (42 CFR 413.234). The ESRD
PPS functional categories represent distinct groupings of drugs or
biologicals, as determined by CMS, whose end action effect is the
treatment or management of a condition or conditions associated with
ESRD. New injectable or intravenous products that are not included in a
functional category in the ESRD PPS base rate are paid for using the
TDAPA for a minimum of 2 years, until sufficient claims data for rate
setting analysis is available. At that point, utilization would be
reviewed and the ESRD PPS base rate modified, if appropriate, to
account for these products. The TDAPA is based on pricing methodologies
under section 1847A of the Act (42 CFR 413.234(c)).
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 4, 2016, we published in the Federal Register a final
rule (81 FR 77384 through 77969) entitled, ``Medicare Program; End-
Stage Renal Disease Prospective Payment System,
[[Page 31195]]
Coverage and Payment for Renal Dialysis Services Furnished to
Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality
Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics
and Supplies Competitive Bidding Program Bid Surety Bonds, State
Licensure and Appeals Process for Breach of Contract Actions, Durable
Medical Equipment, Prosthetics, Orthotics and Supplies Competitive
Bidding Program and Fee Schedule Adjustments, Access to Care Issues for
Durable Medical Equipment; and the Comprehensive End-Stage Renal
Disease Care Model; Final Rule'' (hereinafter referred to as the CY
2017 ESRD PPS final rule). In that rule, we updated the ESRD PPS base
rate for CY 2017, the wage index and wage index floor, the outlier
policy, and the home and self-dialysis training add-on payment
adjustment. For further detailed information regarding these updates,
see 81 FR 77384.
B. Provisions of the Proposed Rule
1. Pricing Eligible Outlier Drugs and Biologicals That Were or Would
Have Been, Prior to January 1, 2011, Separately Billable Under Medicare
Part B
a. Summary of Outlier Calculation
Our regulations at 42 CFR 413.237 specify the methodology used to
calculate outlier payments. Under the ESRD PPS outlier policy, an ESRD
facility is eligible for an outlier payment when the facility's per
treatment imputed MAP amount for ESRD outlier services furnished to a
beneficiary exceeds the predicted ESRD outlier services MAP amount for
outlier services plus the FDL amount, as specified in Sec. 413.237(b).
In the CY 2011 ESRD PPS final rule (75 FR 49134 through 49147), we
discuss the details of establishing the outlier policy under the ESRD
PPS, including determining eligibility for outlier payments. We discuss
the proposed CY 2018 updates to the outlier policy in section II.B.2.c
of this proposed rule.
Under 42 CFR 413.237(a)(1), ESRD outlier services include (1)
certain items and services included in the ESRD PPS bundle that were or
would have been separately billable under Medicare Part B prior to the
implementation of the ESRD PPS, including ESRD-related drugs and
biologicals, ESRD-related laboratory tests, and other ESRD-related
medical/surgical supplies; and (2) certain renal dialysis service drugs
included in the ESRD PPS bundle that were covered under Medicare Part D
prior to the implementation of the ESRD PPS. For CMS to calculate
outlier eligibility and payments, ESRD facilities must identify on the
monthly claim which outlier services have been furnished. CMS provides
a list of outlier services on the CMS Web site, https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/Outlier_Services.html, which is subject to certain additions and
exclusions as discussed in the CY 2012 ESRD PPS final rule (76 FR
70246) and Chapter 8 Section 20.1 of CMS Publication 100-04 (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c08.pdf).
It is important for ESRD facilities to report the outlier services
on the claim because imputed outlier service MAP amounts for a
beneficiary are based on the actual utilization of outlier services.
Specifically, we estimate an ESRD facility's imputed costs for ESRD
outlier services based on available pricing data. In the CY 2011 ESRD
PPS final rule we finalized the pricing data that we use to estimate
imputed outlier services MAP amounts for the different categories of
outlier services (75 FR 49141). With regard to Part B ESRD-related
drugs and biologicals that were separately billable prior to
implementation of the ESRD PPS, we finalized a policy to base the
prices for these items on the most current Average Sales Price (ASP)
data plus 6 percent. Our rationale for this decision was that ASP data
for ESRD-related drugs and biologicals is updated quarterly and was the
basis for payment of these drugs and biologicals prior to the
implementation of the ESRD PPS.
b. Use of ASP Methodology Under the ESRD PPS
Since the implementation of the ESRD PPS, we have referred to the
use of the ASP methodology when we needed to price ESRD-related drugs
and biologicals previously paid separately under Part B (prior to the
ESRD PPS) for purposes of ESRD PPS policies or calculations. For
example, as discussed above, in the CY 2011 ESRD PPS final rule, we
finalized the use of the ASP plus 6 percent methodology for pricing
Part B ESRD-related drugs and biologicals under the outlier policy (75
FR 49141). In the CY 2012 ESRD PPS final rule (76 FR 20244), we stated
that under the outlier policy, we use the ASP methodology.
In the CY 2013 ESRD PPS final rule (77 FR 67463), we finalized that
for CY 2013 and subsequent years we will continue to use the ASP
methodology, including any modifications finalized in the Physician Fee
Schedule (PFS) final rules, to compute outlier MAP amounts. (We
referred to the PFS since this is typically the rulemaking vehicle CMS
uses for provisions related to covered Part B drugs and biologicals,
however, we note that other vehicles such as standalone rules, are used
as well.) In the CY 2013 ESRD PPS final rule, we also finalized the use
of the ASP methodology for any other policy that requires the use of
payment amounts for drugs and biologicals that, absent the ESRD PPS,
would be paid separately.
In accordance with this policy, in the CY 2016 ESRD PPS proposed
rule (80 FR 37829 through 37833), we proposed to use ASP methodology
for purposes of two policies under the ESRD PPS drug designation
process. Specifically, we proposed that any new injectable or
intravenous product that fits into one of the ESRD functional
categories would be considered included in the ESRD PPS and would count
toward the calculation of an outlier payment. We further explained that
in calculating the outlier payment, we price drugs using the ASP
methodology, which is currently ASP + 6 percent (80 FR 37831). In
addition, we proposed that for a new injectable or intravenous product
that is used to treat or manage a condition for which there is not an
ESRD PPS functional category, the new injectable or intravenous product
would be eligible for the TDAPA if it meets specific criteria (80 FR
37831 through 37832). We further proposed that we would base the TDAPA
on the ASP methodology and pay this amount during the utilization data
collection time period (80 FR 37832 through 37833).
As we discussed in the CY 2016 ESRD PPS final rule (80 FR 69023
through 69024), commenters expressed concern regarding the availability
of ASP data when including new injectable or intravenous products into
the ESRD PPS bundled payment, for purposes of both the outlier
calculation and TDAPA. A commenter pointed out that under the proposal,
new products would qualify as outlier services, and if we fail to allow
separate payment at launch, there would be no ASP upon which to base an
outlier payment. That commenter recommended that we consider how to
avoid jeopardizing beneficiary access by implementing an outlier
payment based on wholesale acquisition cost (WAC) or another readily
available price. We agreed with the commenter, and stated that in the
event we do not establish an ASP, WAC could be used. We explained that
we consider WAC pricing to be a part of the pricing methodologies
specified in section 1847A of the Act, and we would use the
methodologies available to us under that authority in order to
accurately determine a price for the calculation of outlier payments
for
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new injectable and intravenous drugs that fit into one of the existing
ESRD PPS functional categories. However, we did not address extending
this policy to Part B ESRD-related drugs and biologicals that are
currently eligible for outlier consideration that may not have ASP
data.
Also, in the CY 2016 ESRD PPS final rule (80 FR 69024), other
commenters expressed concern regarding the use of ASP data for purposes
of the TDAPA. The commenters suggested that ASP would not be truly
reflective of the actual cost of the drugs. One commenter pointed out
that there is often a data lag between ASP and the actual cost of the
drugs and as a result, the TDAPA may not reflect the actual cost of the
drug. We responded that the ASP methodology is a part of the pricing
methodologies specified in section 1847A of the Act, which may also
include WAC pricing during the first quarter of sales as specified in
section 1847A(c)(4) of the Act. We agreed with commenters that ASP
pricing may not always be the most appropriate way to calculate the
TDAPA. Therefore, we revised the regulation text at Sec. 413.234(c)(1)
to refer to the pricing methodologies under section 1847A of the Act,
rather than ASP pricing methodology, because these methodologies
include ASP, as well as WAC.
c. Pricing Methodologies Under Section 1847A of the Act
Medicare Part B follows the provisions under section 1847A of the
Act for purposes of determining the payment amounts for drugs and
biologicals that are described in section 1842(o)(1)(C) of the Act and
that are furnished on or after January 1, 2005. While most Part B drugs
(excluding those paid on a cost or prospective payment basis) are paid
at ASP plus 6 percent, there are cases where ASP is unavailable. For
example, when a new drug or biological is brought to market, sales data
is not sufficiently available for the manufacturer to compute an ASP.
In these cases, the payment amount for these drugs could be determined
using WAC (as specified in section 1847A(c)(4) of the Act) or, when WAC
is not available, the Medicare Administrative Contractor has discretion
in determining the payment amount. Under section 1847A(d) of the Act,
CMS also has the authority to substitute an Average Manufacturer Price
(AMP) or Widely Available Market Price (WAMP)-based payment amount for
the ASP-based payment amount when the ASP exceeds the AMP or WAMP by a
threshold amount. As discussed in the CY 2013 PFS final rule (77 FR
69140 through 69141), the AMP price substitution policy is not utilized
frequently and WAMP-based price substitutions are not currently
implemented. CMS also uses a carryover pricing policy in the very rare
situations when a manufacturer's ASP data for a multiple source drug
product is missing, as discussed in the CY 2011 PFS final rule (75 FR
73461 through 73462).
d. Proposal for Pricing Eligible Outlier Drugs and Biologicals That
Were or Would Have Been, Prior to January 1, 2011, Separately Billable
Under Medicare Part B
As we have described above, section 1847A of the Act provides
methods that are used to determine payment amounts for most separately
paid Part B drugs, that is, drugs and biologicals that are not paid on
a cost or PPS basis (see section 1842(o)(1) of the Act). We are aware
of several circumstances in which an ASP-based payment amount is not
available. For example, an ASP-based payment amount is not available
when there is no longer a Medicare program need for a drug to remain on
the ASP fee schedule, or when drugs or biologicals are new to market
and manufacturers have not yet reported ASP data. However, based on
CMS' experience with determining Part B drug payment limits under
section 1847A of the Act, we believe there are limited situations in
which ASP data would not be available for drugs or biologicals that
could qualify for the outlier calculation. Nevertheless, we believe
that these drugs and biologicals, when they are determined to be an
ESRD outlier service, should count toward the outlier calculation.
In this proposed rule, we propose to extend the use of all pricing
methodologies under section 1847A of the Act for purposes of the ESRD
PPS outlier policy, specifically for current ESRD-related drugs and
biologicals that were or would have been separately billable under Part
B prior to the implementation of the ESRD PPS and are outlier eligible
for CY 2018 and subsequent years. As explained above, we have already
established a policy under the drug designation process in the CY 2016
ESRD PPS final rule (80 FR 69023) whereby we use the pricing
methodologies specified in section 1847A of the Act to determine the
TDAPA for a new injectable or intravenous product that is not
considered included in the ESRD PPS base rate (42 CFR 413.234(c)). In
addition, we have established that we use these methodologies to
determine a price for the calculation of outlier payments for new
injectable and intravenous drugs that fit into one of the existing the
functional categories (80 FR 69023).
We believe that using the pricing methodologies under section 1847A
of the Act is consistent with the ESRD PPS drug designation process and
how covered drugs and biologicals are paid under Medicare Part B. We
believe that consistency with Medicare Part B payment for drugs and
biologicals would be beneficial to ESRD facilities because this is the
way CMS pays for injectable drugs and biologicals on the ESRD claim
with the AY modifier; and therefore facilities would be able to predict
outlier payments. We are proposing to apply any pricing methodology
available under section 1847A of the Act as appropriate when ASP
pricing is unavailable for eligible drugs and biologicals under the
outlier policy that were or would have been separately billable under
Part B prior to the implementation of the ESRD PPS. In situations where
ASP data is not available and other methodologies under section 1847A
of the Act do not apply (including but not limited to AMP price
substitution or carryover pricing), we believe that a WAC-based payment
amount can be determined instead. Based on our experience with
determining Part B drug payments under section 1847A of the Act, we
believe that drugs and biologicals that are approved by the Food and
Drug Administration and are being sold in the United States nearly
always have WAC amounts published in pricing compendia. We believe this
proposal is consistent with the intent of the ESRD PPS outlier policy,
which is to provide a payment adjustment for high cost patients due to
unusual variations in the type or amount of medically necessary care.
If there are drugs and biologicals that ESRD facilities furnish for the
treatment of ESRD that qualify as ESRD outlier services and do not have
ASP data, we would want these items counted toward an outlier payment
since they are a part of the cost the facility is incurring. When a
drug or biological does not have ASP data or WAC data or cannot
otherwise be priced under section 1847A of the Act, we propose that it
would not count toward the outlier calculation. When the utilization of
a drug or biological is not counted toward the outlier calculation, it
may result in a lower outlier payment or no outlier payment to the ESRD
facility.
We are soliciting comment on our proposal to use any pricing
methodology available under section 1847A of the Act for purposes of
the ESRD PPS outlier policy. We are also
[[Page 31197]]
soliciting comment on our proposal that when pricing methodologies are
not available under section 1847A of the Act, the drug or biological
would not count toward the outlier calculation.
2. Proposed CY 2018 ESRD PPS Update
a. ESRD Bundled Market Basket
i. Proposed CY 2018 ESRD Market Basket Update, Productivity Adjustment,
and Labor-Related Share for ESRD PPS
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 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.
Section 1881(b)(14)(F)(i)(I) of the Act, as added by section
217(b)(2)(A) of PAMA, provides that in order to accomplish the purposes
of subparagraph (I) with respect to 2016, 2017, and 2018, after
determining the market basket percentage increase factor for each of
2016, 2017, and 2018, the Secretary shall reduce such increase factor
by 1.25 percentage points for each of 2016 and 2017 and by 1.0
percentage point for 2018. Accordingly, for CY 2018, we will reduce the
proposed amount of the market basket percentage increase factor by 1.0
percent as required by section 1881(b)(14)(F)(i)(I) of the Act, and
will further reduce it by the productivity adjustment.
As required under section 1881(b)(14)(F)(i) of the Act, CMS
developed an all-inclusive ESRDB input price index (75 FR 49151 through
49162) and subsequently revised and rebased the ESRDB input price index
in the CY 2015 ESRD PPS final rule (79 FR 66129 through 66136).
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 2012-based ESRDB market basket as
finalized and described in the CY 2015 ESRD PPS final rule (79 FR 66129
through 66136) to compute the CY 2018 ESRDB market basket increase
factor and labor-related share based on the best available data.
Consistent with historical practice, we estimate the ESRDB market
basket update based on IHS Global Inc.'s (IGI), forecast using the most
recently available data. IGI is a nationally recognized economic and
financial forecasting firm that contracts with CMS to forecast the
components of the market baskets.
Using this methodology and the IGI forecast for the first quarter
of 2017 of the CY 2012-based ESRDB market basket (with historical data
through the fourth quarter of 2016), and consistent with our historical
practice of estimating market basket increases based on the best
available data, the proposed CY 2018 ESRDB market basket increase
factor is 2.2 percent. As required by section 1881(b)(14)(F)(I)(i) of
the Act as amended by section 217(b)(2) of PAMA, we must reduce the
amount of the market basket increase factor by 1.0 percent, resulting
in a proposed CY 2018 ESRDB market basket percentage increase factor of
1.2 percent.
Under section 1881(b)(14)(F)(i) of the Act, as amended by section
3401(h) of the Affordable Care 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 multifactor productivity (MFP) is
derived by subtracting the contribution of labor and capital input
growth from output growth. The detailed methodology for deriving the
MFP projection was finalized 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 Web site at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/MarketBasketResearch.html.
Using IGI's first quarter 2017 forecast, the MFP adjustment for CY
2018 (the 10-year moving average of MFP for the period ending CY 2018)
is projected to be 0.5 percent.
For the CY 2018 ESRD payment update, we propose to continue using a
labor-related share of 50.673 percent for the ESRD PPS payment, which
was finalized in the CY 2015 ESRD PPS final rule (79 FR 66136).
ii. Proposed CY 2018 ESRDB Market Basket Update, Adjusted for
Multifactor Productivity (MFP)
Under section 1881(b)(14)(F) of the Act, beginning in CY 2012, ESRD
PPS payment amounts shall be annually increased by an ESRD market
basket percentage increase factor reduced by the productivity
adjustment. For CY 2018, section 1881(b)(14)(F)(i)(I) of the Act, as
amended by section 217(b)(2)(A)(ii) of PAMA, requires the Secretary to
implement a 1.0 percentage point reduction to the ESRDB market basket
increase factor in addition to the productivity adjustment.
As a result of these provisions, the proposed CY 2018 ESRD market
basket increase is 0.7 percent. This market basket increase is
calculated by starting with the proposed CY 2018 ESRDB market basket
percentage increase factor of 2.2 percent, reducing it by the mandated
legislative adjustment of 1.0 percent (required by section
1881(b)(14)(F)(i)(I) of the Act), and reducing it further by the MFP
adjustment (the 10-year moving average of MFP for the period ending CY
2018) of 0.5 percent. As is our general practice, if more recent data
are subsequently available (for example, a more recent estimate of the
market basket or MFP adjustment), we will use such data to determine
the CY 2018 market basket update and MFP adjustment in the CY 2018 ESRD
PPS final rule.
b. The Proposed CY 2018 ESRD PPS Wage Indices
i. Annual Update of the Wage Index
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 49117), we finalized the use of the Office of Management
and Budget's (OMB's) CBSAs-based geographic area designations to define
urban and rural areas and their corresponding wage index values. OMB
publishes bulletins regarding CBSA changes, including changes to CBSA
numbers and titles. The latest bulletin, as well as subsequent
bulletins, is available online at https://www.whitehouse.gov/omb/information-for-agencies/bulletins.
For CY 2018, we would continue to use the same methodology as
finalized in the CY 2011 ESRD PPS final rule (75 FR 49117) for
determining the wage indices for ESRD facilities. Specifically, we
would update the wage indices for
[[Page 31198]]
CY 2018 to account for updated wage levels in areas in which ESRD
facilities are located. We use the most recent pre-floor, pre-
reclassified hospital wage data collected annually under the inpatient
prospective payment system. 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 pre-floor
hospital data that are unadjusted for occupational mix. The proposed CY
2018 wage index values for urban areas are listed in Addendum A (Wage
Indices for Urban Areas) and the proposed CY 2018 wage index values for
rural areas are listed in Addendum B (Wage Indices for Rural Areas).
Addenda A and B are located on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/End-Stage-Renal-Disease-ESRD-Payment-Regulations-and-Notices.html.
In the CY 2011 and CY 2012 ESRD PPS final rules (75 FR 49116
through 49117 and 76 FR 70239 through 70241, respectively), we also
discussed and finalized the methodologies we use to calculate wage
index values for ESRD facilities that are located in urban and rural
areas where there is no hospital data. For urban areas with no hospital
data, we compute the average wage index value of all urban areas within
the State and 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 wage index for Guam as established in the CY 2014 ESRD
PPS final rule (78 FR 72172) (0.9611) to American Samoa and the
Northern Mariana Islands. We apply the statewide urban average based on
the average of all urban areas within the state (78 FR 72173) (0.8478)
to Hinesville-Fort Stewart, Georgia. We note that if hospital data
becomes available for these areas, we will use that data for the
appropriate CBSAs instead of the proxy.
A wage index floor value has been used instead of the calculated
wage index values below the floor in making payment for renal dialysis
services under the ESRD PPS. 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.
In the CY 2011 ESRD PPS final rule (75 FR 49116 through 49117), we
finalized that we would continue to reduce the wage index floor by 0.05
for each of the remaining years of the ESRD PPS transition, that is,
until CY 2014. In the CY 2012 ESRD PPS final rule (76 FR 70241), we
finalized the 0.05 reduction to the wage index floor for CYs 2012 and
2013, resulting in a wage index floor of 0.5500 and 0.5000,
respectively. We continued to apply and to reduce the wage index floor
by 0.05 in the CY 2013 ESRD PPS final rule (77 FR 67459 through 67461).
Although our intention initially was to provide a wage index floor only
through the 4-year transition to 100 percent implementation of the ESRD
PPS (75 FR 49116 through 49117; 76 FR 70240 through 70241), in the CY
2014 ESRD PPS final rule (78 FR 72173), we continued to apply the wage
index floor and continued to reduce the floor by 0.05 per year for CY
2014 and for CY 2015.
In the CY 2016 ESRD PPS final rule (80 FR 69006 through 69008), we
finalized the continuation of the application of the wage index floor
of 0.4000 to areas with wage index values below the floor, rather than
reducing the floor by 0.05. We stated in that rule that we needed more
time to study the wage indices that are reported for Puerto Rico to
assess the appropriateness of discontinuing the wage index floor. Also,
in that rule a commenter provided three alternative wage indices for
Puerto Rico for the CY 2016 ESRD PPS final rule: (1) Utilize our policy
for areas that do not have reliable hospital data by applying the wage
index for Guam as we did in implementing the ESRD PPS in the Northern
Marianas and American Samoa; (2) use the U.S. Virgin Islands as a proxy
for Puerto Rico, given the geographic proximity and its ``non-
mainland'' or ``island'' nature; or (3) reestablish the wage index
floor in effect in 2010 when Puerto Rico became the only location with
wage areas subject to the floor, that is, 0.65.
In the CY 2017 proposed rule (81 FR 42817), we presented the
findings from analyses of ESRD facility cost report and claims data
submitted by facilities located in Puerto Rico and mainland facilities.
We solicited public comments on the wage index for CBSAs in Puerto Rico
as part of our continuing effort to determine an appropriate course of
action. We did not propose to change the wage index floor for CBSAs in
Puerto Rico, but we requested public comments in which stakeholders can
provide useful input for consideration in future decision-making.
Specifically, we solicited comment on the useful suggestions that were
submitted in the CY 2016 ESRD PPS final rule (80 FR 69007). After
considering the public comments we received regarding the wage index
floor, we finalized the wage index floor of 0.4000 in the CY 2017 ESRD
PPS final rule (81 FR 77858).
In this proposed rule, for CY 2018 and subsequent years, we are
proposing to maintain the current wage index floor of 0.4000 for CBSAs
that have wage values that fall below the floor. The cost report
analyses we have conducted over the past several years are inconclusive
and have not convinced us that an increase in the wage index floor is
warranted at this time.
We continue to believe maintaining the current wage index floor
value of 0.4000 is appropriate as it continues to provide additional
payment support to the lowest wage areas and avoids the need for an
additional budget-neutrality adjustment that would reduce the ESRD PPS
base rate, beyond the adjustment needed to reflect updated hospital
wage data, in order to maintain budget neutrality for wage index
updates. We will continue to monitor and analyze ESRD facility cost
reports and projected impacts to guide future rulemaking with regard to
the wage index floor.
ii. Application of the Wage Index Under the ESRD PPS
A facility's wage index is applied to the labor-related share of
the ESRD PPS base rate. In the CY 2015 ESRD PPS final rule (79 FR
66136), we finalized the labor-related share of 50.673 percent, which
is based on the 2012-based ESRDB market basket. Thus, for CY 2018, the
labor-related share to which a facility's wage index would be applied
is 50.673 percent.
c. CY 2018 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 cancer. The ESRD PPS recognizes high cost patients, and we have
codified the outlier policy in our regulations at 42 CFR 413.237. The
policy provides the following ESRD outlier items and services are
included in the ESRD PPS bundle: (1) ESRD-related drugs and biologicals
that were or would have been, prior to January 1, 2011, separately
billable under Medicare Part B; (2) ESRD-related laboratory tests that
were or would have been, prior to January 1, 2011, separately billable
under Medicare Part B; (3) medical/surgical supplies, including
syringes, used to administer ESRD-related drugs that were or would
[[Page 31199]]
have been, prior to January 1, 2011, separately billable under Medicare
Part B; and (4) renal dialysis services drugs that were or would have
been, prior to January 1, 2011, covered under Medicare Part D,
including ESRD-related oral-only drugs effective January 1, 2025.
In the CY 2011 ESRD PPS final rule (75 FR 49142), we 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 originally specified in
Attachment 3 of Change Request 7064, Transmittal 2033 issued August 20,
2010, 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 was issued to correct the subject on the Transmittal page and
made no other changes.
Furthermore, we use administrative issuances and guidance to
continually update the renal dialysis service items available for
outlier payment via our quarterly update CMS Change Requests, when
applicable. We use this separate guidance to identify renal dialysis
service drugs that were or would have been covered under Medicare Part
D for outlier eligibility purposes and in order to provide unit prices
for calculating imputed outlier services. In addition, we also identify
through our monitoring efforts items and services that are either
incorrectly being identified as eligible outlier services or any new
items and services that may require an update to the list of renal
dialysis items and services that qualify as outlier services, which are
made through administrative issuances.
Our regulations at 42 CFR 413.237 specify the methodology used to
calculate outlier payments. An ESRD facility is eligible for an outlier
payment if its actual or imputed 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)
plus the fixed-dollar loss (FDL) amount. In accordance with Sec.
413.237(c) of our regulations, 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, using 2007 data, we established
the outlier percentage 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 to compute the payment adjustments.
For the CY 2018 outlier policy, we would use the existing
methodology for determining outlier payments by applying outlier
services payment multipliers that were developed for the CY 2016 ESRD
PPS final rule (80 FR 68993-68994, 69002). We used these outlier
services payment multipliers to calculate the predicted outlier service
MAP amounts and projected outlier payments for CY 2018.
For CY 2018, we propose that the outlier services MAP amounts and
FDL amounts would be derived from claims data from CY 2016. 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 2018 would be based on utilization of renal dialysis
items and services furnished under the ESRD PPS in CY 2016. 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.
In the CY 2017 ESRD PPS final rule (81 FR 77860), we stated that
based on the CY 2015 claims data, outlier payments represented
approximately 0.93 percent of total payments. For this proposed rule,
as discussed below, CY 2016 claims data show outlier payments
represented approximately 0.78 percent of total payments. We believe
that trends in the utilization of the ESAs could be a reason for the
decrease. Beginning in 2015 and continuing into 2016, there were large
shifts in the composition of the utilization of ESA drugs.
Specifically, utilization of Epoetin (EPO) alfa decreased and
utilization of the longer-acting ESA drugs, darbepoetin and EPO beta,
increased, based on estimates of average ESA utilization per session.
As EPO alfa is measured in different units than both darbepoetin and
EPO beta, it is difficult to compare the overall utilization of ESAs
between 2014 and 2016 by units alone.
In examining the claims data, we find that compositional shift away
from use of EPO alfa to the longer acting darbepoetin and EPO beta was
a significant factor in the decrease in total ESA costs in 2016. We
first calculated the actual cost for ESAs administered during 2016. We
then calculated the projected cost of ESAs that was used for the CY
2016 ESRD PPS final rule, using total utilization from 2014 and drug
prices from 2015 Q3 inflated to 2016 prices. The actual costs of ESAs
administered in 2016 were roughly 20 percent lower than the value
projected in the CY 2016 ESRD PPS final rule. We then calculated the
projected cost of ESAs assuming that the utilization of various ESAs
per dialysis session in 2014 and 2016 were similar and also used the
prices and total dialysis session count from 2016. The projected costs
from these two scenarios were similar and suggest that compositional
change in ESA utilization was likely a significant factor in the
decrease in the total cost of ESAs between 2014 and 2016. We continue
to believe that the decline is leveling off and that 1.0 percent is an
appropriate threshold for outlier payments.
i. CY 2018 Update to the Outlier Services MAP Amounts and FDL Amounts
For CY 2018, we are not proposing any change to the methodology
used to compute the MAP or FDL amounts. Rather, we will continue to
update the outlier services MAP amounts and FDL amounts to reflect the
utilization of outlier services reported on 2016 claims. For this
proposed rule, the outlier services MAP amounts and FDL amounts were
updated using 2016 claims data. The impact of this update is shown in
Table 1, which compares the outlier services MAP amounts and
[[Page 31200]]
FDL amounts used for the outlier policy in CY 2017 with the updated
proposed estimates for this rule. The estimates for the proposed CY
2018 outlier policy, which are included in Column II of Table 1, were
inflation adjusted to reflect projected 2018 prices for outlier
services.
Table 1--Outlier Policy: Impact of Using Updated Data To Define the Outlier Policy
----------------------------------------------------------------------------------------------------------------
Column I Final outlier policy Column II Proposed outlier
for CY 2017 (based on 2015 policy for CY 2018 (based on
data, price inflated to 2017) 2016 data, price inflated to
* 2018)
---------------------------------------------------------------
Age <18 Age >=18 Age <18 Age >=18
----------------------------------------------------------------------------------------------------------------
Average outlier services MAP amount per $38.77 $47.00 $38.20 $44.52
treatment......................................
Adjustments..................................... .............. .............. .............. ..............
Standardization for outlier services............ 1.0078 0.9770 1.0218 0.9788
MIPPA reduction................................. 0.98 0.98 0.98 0.98
Adjusted average outlier services MAP amount.... $38.29 $45.00 $38.25 $42.70
Fixed-dollar loss amount that is added to the $68.49 $82.92 $49.55 $83.12
predicted MAP to determine the outlier
threshold......................................
Patient-months qualifying for outlier payment... 4.6% 6.7% 7.4% 6.3%
----------------------------------------------------------------------------------------------------------------
* Note that Column I was obtained from Column II of Table 1 from the CY 2017 ESRD PPS final rule.
As demonstrated in Table 1, the estimated FDL amount per treatment
that determines the CY 2018 outlier threshold amount for adults (Column
II; $83.12) is higher than that used for the CY 2017 outlier policy
(Column I; $82.92). The higher threshold is accompanied by a decrease
in the adjusted average MAP for outlier services from $45.00 to $42.70.
For pediatric patients, there is a decrease in the FDL amount from
$68.49 to $49.55. There is a slight decrease in the adjusted average
MAP for outlier services among pediatric patients, from $38.29 to
$38.25.
We estimate that the percentage of patient months qualifying for
outlier payments in CY 2018 will be 6.3 percent for adult patients and
7.4 percent for pediatric patients, based on the 2016 claims data. The
pediatric 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).
ii. Outlier Percentage
In the CY 2011 ESRD PPS final rule (75 FR 49081), 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 2016 claims, outlier payments represented approximately 0.78
percent of total payments, slightly below the 1 percent target due to
small overall declines in the use of outlier services. Recalibration of
the thresholds using 2016 data is expected to result in aggregate
outlier payments close to the 1 percent target in CY 2018. We believe
the update to the outlier MAP and FDL amounts for CY 2018 would
increase payments for ESRD beneficiaries requiring higher resource
utilization and move us closer to meeting our 1 percent outlier policy.
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, but would increase payments to ESRD
facilities for beneficiaries with renal dialysis items and services
that are eligible for outlier payments. Therefore, beneficiary co-
insurance obligations would also increase for renal dialysis services
eligible for outlier payments.
d. Proposed Impacts to the CY 2018 ESRD PPS Base Rate
i. ESRD PPS Base Rate
In the CY 2011 ESRD PPS final rule (75 FR 49071 through 49083), we
discussed the development of the ESRD PPS per treatment base rate that
is codified in the Medicare regulations at Sec. 413.220 and Sec.
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 regulations at Sec. 413.230, the ESRD PPS base rate is
adjusted for the patient specific case-mix adjustments, applicable
facility adjustments, geographic differences in area wage levels using
an area wage index, as well as applicable outlier payments, training
add-on payments, or transitional drug add-on payments.
ii. Annual Payment Rate Update for CY 2018
We are proposing an ESRD PPS base rate for CY 2018 of $233.31. This
update reflects several factors, described in more detail as follows:
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 2018 projection for the ESRDB
market basket is 2.2 percent. In CY 2018, this amount must be reduced
by 1.0 percentage point as required by section 1881(b)(14)(F)(i)(I) of
the Act, as amended by section 217(b)(2)(A) of PAMA, which is
calculated as 2.2-1.0 = 1.2 percent. This amount is then 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. The
proposed MFP adjustment for CY 2018 is 0.5 percent, thus yielding a
proposed update to the base rate of 0.7 percent for CY 2018 (1.2-0.5 =
0.7 percent). Therefore, the proposed ESRD PPS base rate for CY 2018
before application of the wage index budget-neutrality adjustment
factor would be $233.17 ($231.55 x 1.007 = $233.17).
Wage Index Budget-Neutrality Adjustment Factor: We compute
a wage
[[Page 31201]]
index budget-neutrality adjustment factor that is applied to the ESRD
PPS base rate. For CY 2018, 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). The CY 2018 proposed
wage index budget-neutrality adjustment factor is 1.000605. This
application would yield a CY 2018 ESRD PPS proposed base rate of
$233.31 ($233.17 x 1.000605 = $233.31).
In summary, we are proposing a CY 2018 ESRD PPS base rate of
$233.31. This amount reflects a market basket increase of 0.7 percent
and the CY 2018 wage index budget-neutrality adjustment factor of
1.000605.
III. CY 2018 Payment for Renal Dialysis Services Furnished to
Individuals With Acute Kidney Injury (AKI)
A. Background
On June 29, 2015, the Trade Preferences Extension Act of 2015
(TPEA) (Pub. L. 114-27) was enacted. In the TPEA, the Congress amended
the Act to include coverage and provide for payment for dialysis
furnished by an ESRD facility to an individual with acute kidney injury
(AKI). Specifically, 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 AKI. Section 808(b) of the TPEA amended
section 1834 of the Act by adding a new subsection (r) to the Act.
Subsection (r)(1) of section 1834 of the Act provides for payment,
beginning January 1, 2017, 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, as adjusted by any applicable geographic adjustment applied under
section 1881(b)(14)(D)(iv)(II) of the Act and may be adjusted by the
Secretary (on a budget neutral basis for payments under section 1834(r)
of the Act) by any other adjustment factor under section 1881(b)(14)(D)
of the Act.
In the CY 2017 ESRD PPS final rule, we finalized several coverage
and payment policies in order to implement subsection (r) of section
1834 of the Act and the amendments to section 1881(s)(2)(F) of the Act,
including the payment rate for AKI dialysis (81 FR 77866 through
77872). We interpret section 1834(r)(1) of the Act to mean the amount
of payment for AKI dialysis services is the base rate for renal
dialysis services determined for such year under the ESRD base rate as
set forth in 42 CFR 413.220, updated by the ESRD bundled market basket
percentage increase factor minus a productivity adjustment as set forth
in Sec. 413.196(d)(1), adjusted for wages as set forth in Sec.
413.231, and adjusted by any other amounts deemed appropriate by the
Secretary under Sec. 413.373. We codified this policy in 42 CFR
413.372.
B. Annual Payment Rate Update for CY 2018
1. CY 2018 AKI Dialysis Payment Rate
The payment rate for AKI dialysis is the ESRD PPS base rate
determined for a year under section 1881(b)(14) of the Act, which is
the finalized ESRD PPS base rate. We note that ESRD facilities have the
ability to bill Medicare for non-renal dialysis items and services and
receive separate payment in addition to the payment rate for AKI
dialysis.
As discussed in section II.B.2.d of this proposed rule, the CY 2018
proposed ESRD PPS base rate is $233.31, which reflects the ESRD bundled
market basket and multifactor productivity adjustment. Accordingly, we
are proposing a CY 2018 per treatment payment rate of $233.31 for renal
dialysis services furnished by ESRD facilities to individuals with AKI.
2. Geographic Adjustment Factor
Section 1834(r)(1) of the Act further provides that the amount of
payment for AKI dialysis services shall be the base rate for renal
dialysis services determined for a year under section 1881(b)(14) of
the Act, as adjusted by any applicable geographic adjustment factor
applied under section 1881(b)(14)(D)(iv)(II) of the Act. We interpret
the reference to ``any applicable geographic adjustment factor applied
under subparagraph (D)(iv)(II) of such section'' to mean the geographic
adjustment factor that is actually applied to the ESRD PPS base rate
for a particular facility. Accordingly, we apply the same wage index
that is used under the ESRD PPS, as discussed in section II.B.2.d of
this proposed rule. In the CY 2017 ESRD PPS final rule (81 FR 77868),
we finalized that the AKI dialysis payment rate will be adjusted for
wage index for a particular ESRD facility in the same way that the ESRD
PPS base rate is adjusted for wage index for that facility.
Specifically, we apply the wage index to the labor-related share of the
ESRD PPS base rate that we utilize for AKI dialysis to compute the wage
adjusted per-treatment AKI dialysis payment rate. As stated above, we
are proposing a CY 2018 AKI dialysis payment rate of $233.31, adjusted
by the ESRD facility's wage index.
IV. End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) for
Payment Year (PY) 2021
A. Background
For over 30 years, monitoring the quality of care provided to end-
stage renal disease (ESRD) patients by dialysis providers or facilities
(hereinafter referred to collectively as ``facility'' or
``facilities'') has been an important component of the Medicare ESRD
payment system. The ESRD quality incentive program (QIP) is the most
recent step in fostering improved patient outcomes by establishing
incentives for dialysis facilities to meet or exceed performance
standards established by the Centers for Medicare & Medicaid Services
(CMS).
Under the ESRD QIP, payments made to a dialysis facility by
Medicare under section 1881(b)(14) of the Social Security Act (the Act)
are reduced by up to 2 percent if the facility does not meet or exceed
the total performance score with respect to performance standards
established by the Secretary of the Department of Health and Human
Services (the Secretary) with respect to certain specified measures.
The calendar year (CY) 2012 ESRD PPS final rule (76 FR 70228),
published in the Federal Register on November 10, 2011, among other
things, set forth certain requirements for the ESRD QIP for payment
years (PYs) 2013 and 2014.
The CY 2013 ESRD PPS final rule (77 FR 67450), published in the
Federal Register on November 9, 2012, set forth requirements for the
ESRD QIP, including for payment year 2015 and beyond. In that rule, CMS
added several new measures to the ESRD QIP's measure set and expanded
the scope of some of the existing measures. CMS also established CY
2013 as the performance period for the PY 2015 ESRD QIP, established
performance standards and adopted scoring and payment methodologies
similar to those finalized for the PY 2014 ESRD QIP.
The CY 2014 ESRD PPS final rule (78 FR 72156), published in the
Federal Register on December 2, 2013, set forth requirements for the
ESRD QIP, including for PY 2016 and beyond. In that rule, CMS added
several new measures to the ESRD QIP's measure set, established the
performance period for the PY 2016 ESRD QIP, established performance
standards for the PY 2016 measures, and adopted scoring and payment
reduction methodologies that
[[Page 31202]]
were similar to those finalized for the PY 2015 ESRD QIP.
The CY 2015 ESRD PPS final rule (79 FR 66120), published in the
Federal Register on November 6, 2014, finalized requirements for the
ESRD QIP, including for PYs 2017 and 2018. In that rule, CMS finalized
the measure set for both PYs 2017 and 2018, revised the In-Center
Hemodialysis Consumer Assessment of Healthcare Providers (ICH CAHPS)
reporting measure, revised the Mineral Metabolism Reporting Measure,
finalized an Extraordinary Circumstances Exemption, and finalized a new
scoring methodology beginning with PY 2018.
The CY 2016 ESRD PPS final rule (80 FR 68968), published in the
Federal Register on November 6, 2015, set forth requirements for the
ESRD QIP, including for PYs 2017 through 2019. In that rule, CMS
finalized the PY 2019 Measure Set, reinstated the ICH CAHPS Attestation
beginning with PY 2017, and revised the Small Facility Adjuster (SFA)
beginning with PY 2017.
The CY 2017 ESRD PPS final rule (81 FR 77834), published in the
Federal Register on November 4, 2016, set forth new requirements for
the ESRD QIP, including the inclusion of new quality measures beginning
with PYs 2019 and 2020, and updated other policies for the program.
The ESRD QIP is authorized by section 1881(h) of the Act, which was
added by section 153(c) of Medicare Improvements for Patients and
Providers Act of 2008 (MIPPA). Section 1881(h) of the Act requires the
Secretary to establish an ESRD QIP by (1) selecting measures; (2)
establishing the performance standards that apply to the individual
measures; (3) specifying a performance period with respect to a year;
(4) developing a methodology for assessing the total performance of
each facility based on the performance standards with respect to the
measures for a performance period; and (5) applying an appropriate
payment reduction to facilities that do not meet or exceed the
established Total Performance Score (TPS). This proposed rule discusses
each of these elements and our proposals for their application to the
ESRD QIP.
B. Accounting for Social Risk Factors in the ESRD QIP Program
We understand that social risk factors such as income, education,
race and ethnicity, employment, disability, community resources, and
social support (certain factors of which are also sometimes referred to
as socioeconomic status factors or socio-demographic status factors),
play a major role in health. One of our core objectives is to improve
beneficiary outcomes, including reducing health disparities, and we
want to ensure that all beneficiaries, including those with social risk
factors, receive high quality care. In addition, we seek to ensure that
the quality of care furnished by facilities is assessed as fairly as
possible under our programs while ensuring that beneficiaries have
adequate access to excellent care.
We have been reviewing reports prepared by the Office of the
Assistant Secretary for Planning and Evaluation (ASPE) \2\ and the
National Academies of Sciences, Engineering, and Medicine on the issue
of accounting for social risk factors in CMS' value-based purchasing
and quality reporting programs, and considering options on how to
address the issue in these programs. On December 21, 2016, ASPE
submitted a Report to Congress on a study it was required to conduct
under section 2(d) of the Improving Medicare Post-Acute Care
Transformation (IMPACT) Act of 2014. The study analyzed the effects of
certain social risk factors in Medicare beneficiaries on quality
measures and measures of resource use that are used in one or more of
nine Medicare value-based purchasing programs, including the ESRD
QIP.\3\ The report also included considerations for strategies to
account for social risk factors in these programs. In a January 10,
2017 report released by The National Academies of Sciences,
Engineering, and Medicine, that body provided various potential methods
for measuring and accounting for social risk factors, including
stratified public reporting.\4\
---------------------------------------------------------------------------
\2\ Office of the Assistant Secretary for Planning and
Evaluation. 2016. Report to Congress: Social Risk Factors and
Performance Under Medicare's Value-Based Purchasing Programs.
Available at: https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs.
\3\ Office of the Assistant Secretary for Planning and
Evaluation. 2016. Report to Congress: Social Risk Factors and
Performance Under Medicare's Value-Based Purchasing Programs.
Available at: https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs.
\4\ National Academies of Sciences, Engineering, and Medicine.
2017. Accounting for social risk factors in Medicare payment.
Washington, DC: The National Academies Press.
---------------------------------------------------------------------------
As noted in the fiscal year (FY) 2017 Inpatient Prospective Payment
System/Long-Term Care Hospital Prospective Payment System (IPPS/LTCH
PPS) final rule (81 FR 56762 through 57345), the National Quality Forum
(NQF) has undertaken a 2-year trial period in which certain new
measures, measures undergoing maintenance review, and measures endorsed
with the condition that they enter the trial period can be assessed to
determine whether risk adjustment for selected social risk factors is
appropriate for these measures. This trial entails temporarily allowing
inclusion of social risk factors in the risk-adjustment approach for
these measures. At the conclusion of the trial, NQF will issue
recommendations on the future inclusion of social risk factors in risk
adjustment for these quality measures, and we will closely review its
findings.
As we continue to consider the analyses and recommendations from
these reports and await the results of the NQF trial on risk adjustment
for quality measures, we are continuing to work with stakeholders in
this process. As we have previously communicated, we are concerned
about holding facilities to different standards for the outcomes of
their patients with social risk factors because we do not want to mask
potential disparities or minimize incentives to improve the outcomes
for disadvantaged populations. Keeping this concern in mind, while we
sought input on this topic previously, we continue to seek public
comment on whether we should account for social risk factors in the
ESRD QIP, and if so, what method or combination of methods would be
most appropriate for accounting for social risk factors. Examples of
methods include: (1) Adjustment of the payment adjustment methodology
under the ESRD QIP; (2) adjustment of provider performance scores (for
instance, stratifying facilities based on the proportion of their
patients who are dual eligible); (3) confidential reporting of
stratified measure rates to facilities; public reporting of stratified
measure rates; (4) risk adjustment of a particular measure as
appropriate based on data and evidence; and (5) redesigning payment
incentives (for instance, rewarding improvement for facilities caring
for patients with social risk factors or incentivizing facilities to
achieve health equity).
We note that in section V.I.9 of the FY 2018 IPPS proposed rule (82
FR 19796), we discuss considerations for stratifying hospitals into
peer groups for purposes of assessing payment adjustments under the
Hospital Readmissions Reduction Program, as required under the 21st
Century Cures Act of 2016 (Cures Act). We refer readers to that rule
for a detailed discussion of these alternatives; while this discussion
and corresponding proposal are specific to the Hospital Readmissions
Reduction Program, they reflect the level of analysis we would
undertake when evaluating methods and combinations of methods for
accounting for social risk factors in
[[Page 31203]]
CMS' other value-based purchasing programs, such as the ESRD QIP. While
we consider whether and to what extent we currently have statutory
authority to implement one or more of the above-described methods, we
are seeking comments on whether any of these methods should be
considered, and if so, which of these methods or combination of methods
would best account for social risk factors in the ESRD QIP.
In addition, we are seeking public comment on which social risk
factors might be most appropriate for stratifying measure scores and/or
potential risk adjustment of a particular measure. Examples of social
risk factors include, but are not limited to, dual eligibility/low-
income subsidy, race and ethnicity, and geographic area of residence.
We are seeking comments on which of these factors, including current
data sources where this information would be available, could be used
alone or in combination, and whether other data should be collected to
better capture the effects of social risk. We will take commenters'
input into consideration as we continue to assess the appropriateness
and feasibility of accounting for social risk factors in the ESRD QIP.
We note that any such changes would be proposed through future notice-
and-comment rulemaking.
We look forward to working with stakeholders as we consider the
issue of accounting for social risk factors and reducing health
disparities in the Medicare programs. Implementing any of the above
methods would be taken into consideration in the context of how this
and other Medicare programs operate (for example, data submission
methods, availability of data, statistical considerations relating to
reliability of data calculations, among others). We also welcome
comment on operational considerations. CMS is committed to ensuring
that its beneficiaries have access to and receive excellent care, and
that the quality of care furnished by facilities is assessed fairly in
the Medicare programs.
C. Proposed Change to the Performance Score Certificate Beginning With
the Payment Year (PY) 2019 ESRD QIP
In a final rule, which published in the Federal Register on January
5, 2011, we finalized a policy for informing the public of facility
performance through facility-posted certificates (76 FR 637). We
finalized that these Performance Score Certificates (PSCs) would
include the following information: (1) The TPS achieved by the facility
under the ESRD QIP with respect to the payment year involved; (2)
comparative data that shows how well the facility's TPS compares to the
national TPS; (3) the performance result that the facility achieved on
each individual measure with respect to the year involved; and (4)
comparative data that shows how well the facility's individual quality
measure performance scores compare to the national performance result
for each quality measure (76 FR 637). As the ESRD QIP has become more
complex over the years and as new measures have been added to the
program, the PSC has become a lengthy document that facilities are
required to print and post in both English and Spanish for their
patients to view (77 FR 67517). We have received feedback from the
community about the difficulty patients and their families have with
interpreting and understanding the information contained on the PSC due
to its sheer volume and complexity.
Section 1881(h)(6)(C) of the Act only requires that the PSC
indicate the TPS achieved by the facility with respect to a program
year. Therefore, in an effort to make the PSC a more effective and
understandable document for the community, we are proposing to shorten
the PSC by removing some of the information we had previously finalized
would be included in the document. We propose that beginning in PY 2019
and continuing in future years, the PSC will indicate the facility's
TPS, as required under section 1881(h)(6)(C) of the Act, as well as
information sufficient to identify the facility (name, address, etc.).
Additionally, we are proposing to include on the PSC information
showing how the facility's TPS compared to the national average TPS for
that specific payment year.
We are not proposing any other changes to the requirements we
previously finalized for the PSC.
We seek comments on this proposal, and we are particularly
interested in comments on whether the reduced amount of information on
the PSC would both benefit facilities and enhance the public's
understanding of the TPS.
D. Proposed Requirements Beginning With the PY 2020 ESRD QIP
1. Proposal To Clarify the Minimum Data Policy for Scoring Measures
Finalized for the PY 2020 ESRD QIP
Under our current policy, we begin counting the number of months in
which a facility is open on the first day of the month after the
facility's CCN Open Date. In the CY 2017 ESRD PPS final rule (81 FR
77926), we inadvertently made errors in finalizing how we intended this
policy to apply to a number of measures in the PY 2020 ESRD QIP, and we
are proposing the intended application of this policy for PY 2020 in
this proposed rule. We are not proposing any changes to the methodology
we use to count the number of months for which a facility is open for
purposes of scoring facilities on clinical and reporting measures, or
to the minimum number of cases (qualifying patients, survey-eligible
patients, index discharges, or patient-years at risk) that applies to
each measure. Table 2 displays the proposed patient minimum
requirements for each of the measures finalized for PY 2020, as well as
the proposed CCN Open Dates after which a facility would not be
eligible to receive a score on a reporting measure.
Table 2--Proposed Minimum Data Requirements for the PY 2020 ESRD QIP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Measure Minimum data requirements CCN open date Small facility adjuster
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dialysis Adequacy (Clinical)........ 11 qualifying patients...... N/A...................................... 11-25 qualifying patients.
Vascular Access Type: Catheter 11 qualifying patients...... N/A...................................... 11-25 qualifying patients.
(Clinical).
Vascular Access Type: Fistula 11 qualifying patients...... N/A...................................... 11-25 qualifying patients.
(Clinical).
Hypercalcemia (Clinical)............ 11 qualifying patients...... N/A...................................... 11-25 qualifying patients.
NHSN Bloodstream Infection 11 qualifying patients...... Before January 1, 2018................... 11-25 qualifying patients.
(Clinical).
NHSN Dialysis Event (Reporting)..... 11 qualifying patients...... Before January 1, 2018................... 11-25 qualifying patients.
SRR (Clinical)...................... 11 index discharges......... N/A...................................... 11-41 index discharges.
[[Page 31204]]
STrR (Clinical)..................... 10 patient-years at risk.... N/A...................................... 10-21 patient years at risk.
SHR (Clinical)...................... 5 patient-years at risk..... N/A...................................... 5-14 patient-years at risk.
ICH CAHPS (Clinical)................ Facilities with 30 or more Before January 1, 2018................... N/A.
survey-eligible patients
during the calendar year
preceding the performance
period must submit survey
results. Facilities will
not receive a score if they
do not obtain a total of at
least 30 completed surveys
during the performance
period.
Anemia Management (Reporting)....... 11 qualifying patients...... Before July 1, 2018...................... N/A.
Serum Phosphorus (Reporting)........ 11 qualifying patients...... Before July 1, 2018...................... N/A.
Depression Screening and Follow-Up 11 qualifying patients...... Before July 1, 2018...................... N/A.
(Reporting).
Pain Assessment and Follow-Up 11 qualifying patients...... Before July 1, 2018...................... N/A.
(Reporting).
NHSN Healthcare Personnel Influenza N/A......................... Before January 1, 2018................... N/A.
Vaccination (Reporting).
Ultrafiltration Rate (Reporting).... 11 qualifying patients...... Before July 1, 2018...................... N/A.
--------------------------------------------------------------------------------------------------------------------------------------------------------
We welcome comments on this proposal.
2. Proposed Changes to the Extraordinary Circumstances Exception (ECE)
Policy
Many of our quality reporting and value-based purchasing programs
share a common process for requesting an exception from program
reporting due to an extraordinary circumstance not within a facility's
control. The Hospital Inpatient Quality Reporting, Hospital Outpatient
Quality Reporting, Inpatient Psychiatric Facility Quality Reporting,
Ambulatory Surgical Center Quality Reporting, PPS-Exempt Cancer
Hospital Quality Reporting, the Hospital Acquired Condition Reduction
Program, and the Hospital Readmissions Reduction Program all share
common processes for ECE requests. In reviewing the policies for these
programs, we recognized that there are five areas in which these
programs have variance in comparison to the policy within the ESRD QIP
regarding ECE requests. These are: (1) Allowing the facilities or
hospitals to submit a form signed by the facility's or hospital's CEO
versus CEO or designated personnel; (2) requiring the form be submitted
within 30 days following the date that the extraordinary circumstance
occurred versus within 90 days following the date the extraordinary
circumstance occurred; (3) inconsistency regarding specification of a
timeline for us to provide our response notifying the facility or
hospital of our decision; (4) inconsistency regarding whether we would
grant ECEs based on a facility's inability to timely and completely
report data due to CMS data system issues; and (5) referring to this
policy as ``extraordinary extensions/exemptions'' versus as
``extraordinary circumstances exceptions.'' We believe that aligning
the way the ECE policy is implemented in our program, with the way it
is implemented in the programs listed above, can improve the overall
administrative efficiencies for affected facilities or hospitals.
In the CY 2015 ESRD PPS final rule (79 FR 66120 through 66265), we
finalized that to receive consideration for an exception from the ESRD
QIP requirements in effect during the time period that a facility is
affected by an extraordinary circumstance, facilities would need to be
closed and provide CMS with a CMS Disaster Extension/Exception Request
Form within 90 calendar days of the date of the disaster or
extraordinary circumstance (79 FR 66190). We finalized that the
facility would need to provide the following information on the form:
Facility CMS Certification Number (CCN).
Facility name.
CEO name and contact information.
Additional contact name and contact information.
Reason for requesting an exception.
Dates affected.
Date facility will start submitting data again, with
justification for this date.
Evidence of the impact of the extraordinary circumstances,
including but not limited to photographs, newspaper, and other media
articles.
We also finalized that we would consider granting an ECE to
facilities absent a request, if we determine that an extraordinary
circumstance affected an entire region or locale (79 FR 66190).
We are proposing to update these policies by: (1) Allowing the
facility to submit a form signed by the facility's CEO or designated
personnel; (2) expanding the reasons for which an ECE can be requested
to include an unresolved issue with a CMS data system, which affected
the ability of the facility to submit data (an unresolved data system
issue would be one which did not allow the facility to submit data by
the data submission deadline and which was unable to be resolved with a
work-around), and (3) specifying that a facility does not need to be
closed in order to request and receive consideration for an ECE, as
long as the facility can demonstrate that its normal operations have
been significantly affected by an extraordinary circumstance outside of
its control. These proposed policies generally align with policies in
the Hospital Inpatient Quality Reporting Program (76 FR 51651 through
51652), (78 FR 50836 through 50837) and (81 FR 57181 through 57182),
Hospital Outpatient Quality Reporting Program (77 FR 68489 and 81 FR
79795), as well as ECE policies we have finalized for other quality
reporting and value-based purchasing programs. We are proposing that
these policies would apply beginning with the PY 2020 ESRD QIP program,
as related to extraordinary circumstance events that occur on or after
January 1, 2018.
We note that there may be circumstances in which it is not feasible
for a facility's CEO to sign the ECE request form. In these
circumstances, we believe that facilities affected by such
[[Page 31205]]
circumstances should be able to submit an ECE request regardless of the
CEO's availability to sign. This proposed change would allow facilities
to designate an appropriate, non-CEO contact for this purpose. We would
accept ECE forms which have been signed by designated personnel.
Although we do not anticipate that unresolved issues with CMS data
systems will happen on a regular basis, we also recognize that there
may be times when CMS experiences issues with its data systems that
inhibits facilities' ability to submit data. We are often able to
resolve such issues and will allow facilities an extended period of
time to report the data. However, in the case that the issue inhibits
the complete reporting of data (even under an extended deadline), we
believe it would be inequitable to take the absence of such unreported
data into account when computing a facility's TPS for a payment year.
Therefore, we are proposing to address these situations in one of two
ways. In some cases, CMS may issue a blanket exemption to facilities
that have been affected by an unresolved technical issue. In such
cases, facilities would not be required to submit an ECE request to
CMS, and CMS would send communications about the blanket waiver to the
affected facilities using routine communication channels. In other
cases, CMS may not issue a blanket exemption to facilities. In these
cases, facilities would be required to submit an ECE request to CMS
using the regular ECE request process, and would need to indicate how
they were directly affected by the technical issue.
Furthermore, we believe that it is important for facilities to
receive timely feedback regarding the status of ECE requests. We strive
to complete our review of each ECE request as quickly as possible.
However, we recognize that the number of requests we receive, and the
complexity of the information provided impacts the actual timeframe to
make ECE determinations. To improve transparency of our process, we
believe it is appropriate to specify that we will strive to complete
our review of each request within 90 days of receipt.
We seek comments on these proposals.
3. Solicitation of Comments on the Inclusion of Acute Kidney Injury
(AKI) Patients in the ESRD QIP
The services for which quality is measured under the ESRD QIP are
renal dialysis services defined in section 1881(b)(14)(B) of the Act.
Prior to January 1, 2017, these services could only be covered and
reimbursed under Medicare if they were furnished to individuals with
ESRD, but they are now also covered and reimbursed if they are
furnished by renal dialysis facilities or providers of services paid
under section 1881(b)(14) of the Act to individuals with acute kidney
injury (AKI) (see section 1861(s)(2)(F) and 1834(r) of the Act).
We currently do not require facilities to report AKI patient data
for any of our measures in the ESRD QIP, including the NHSN BSI
Clinical and Reporting Measures.\5\ However, we now have the authority
to collect data on this patient population and believe that it is
vitally important to monitor and measure the quality of care furnished
to these patients.
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\5\ To the extent that the CDC requires facilities to report AKI
patient data under its own, separate, statutory authority, data on
these patients is not shared with CMS or used in the calculation of
any ESRD QIP measures, including the NHSN Clinical and Reporting
Measures.
---------------------------------------------------------------------------
In the future, we intend to require facilities to report data on
AKI patients under the ESRD QIP. We are seeking comments on whether and
how to adapt any of our current measures to include this population, as
well as the type of measures that might be appropriate to develop for
future inclusion in the program that would address the unique needs of
beneficiaries with AKI.
4. Estimated Performance Standards, Achievement Thresholds, and
Benchmarks for the Clinical Measures Finalized for the PY 2020 ESRD QIP
In the CY 2017 ESRD PPS final rule (81 FR 77834 through 77969), we
finalized that for PY 2020, the performance standards, achievement
thresholds, and benchmarks for the clinical measures would be set at
the 50th, 15th and 90th percentile, respectively, of national
performance in CY 2016, because this will give us enough time to
calculate and assign numerical values to the proposed performance
standards for the PY 2020 program prior to the beginning of the
performance period (81 FR 77915). At this time, we do not have the
necessary data to assign numerical values to those performance
standards, achievement thresholds, and benchmarks because we do not yet
have complete data from CY 2016. Nevertheless, we are able to estimate
these numerical values based on the most recent data available. For the
VAT, Hypercalcemia, NHSN BSI, In-Center Hemodialysis Consumer
Assessment of Healthcare Providers and Systems (ICH CAHPS),
Standardized Readmission Ratio (SRR), and Standardized Transfusion
Ratio (STrR) clinical measures, this data comes from the period of
January through December 2015. In Table 3, we have provided the
estimated numerical values for all finalized PY 2020 ESRD QIP clinical
measures. We will publish updated values for the clinical measures,
using data from the first part of CY 2017, in the CY 2018 ESRD PPS
final rule.
[[Page 31206]]
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In previous rulemaking, we have finalized that if final numerical
values for the performance standard, achievement threshold, and/or
benchmark are worse than they were for that measure in the previous
year of the ESRD QIP, then we would substitute the previous year's
performance standard, achievement threshold, and/or benchmark for that
measure. We finalized this policy because we believe that the ESRD QIP
should not have lower performance standards than in previous years. In
the CY 2017 ESRD PPS final rule, we finalized an update to that policy
because in certain cases, it may be appropriate to re-baseline the NHSN
BSI Clinical Measure, such that expected infection rates are calculated
on the basis of a more recent year's data (81 FR 77886). In such cases,
numerical values assigned to performance standards may appear to
decline, even though they represent higher standards for infection
prevention. For PY 2020 and future payment years, we propose to
continue use of this policy for the reasons explained above. Therefore,
for PY 2020, with the exception of the NHSN BSI Clinical Measure, we
will substitute the PY 2019 performance standard, achievement
threshold, and/or benchmark for any measure that has a final numerical
value for a performance standard, achievement threshold, and/or
benchmark that is worse than it was for that measure in the PY 2019
ESRD QIP. Based upon the estimated values shown above, we do not
anticipate needing to substitute the performance standards from PY 2019
for any measures included in the PY 2020 ESRD QIP.
Although we are not proposing any changes to this policy, we are
seeking comments on whether we should continue to use this policy in
the future.
5. Policy for Weighting the Clinical Measure Domain for PY 2020
In the CY 2017 ESRD PPS final rule, we finalized our policy for
weighting the Clinical Measure Domain for PY 2020. With the addition of
the Safety Measure Domain to the ESRD QIP Program, we finalized that
the Clinical Measure Domain would comprise 75 percent of the TPS, the
Safety Measure Domain would comprise 15 percent of the TPS and the
Reporting Measure Domain would comprise 10 percent of the TPS. Table 4
shows the weights finalized for PY 2020 for the Clinical Measure
Domain.
[[Page 31207]]
Table 4--Finalized Clinical Measure Domain Weighting for the PY 2020 ESRD QIP
----------------------------------------------------------------------------------------------------------------
Measure weight in the
Measures/measure topics by clinical domain score Measure weight as percent of TPS (updated)
subdomain (percent)
----------------------------------------------------------------------------------------------------------------
Patient and Family Engagement/ 40......................
Care Coordination Subdomain.
ICH CAHPS measure........... 25...................... 18.75.
SRR Measure................. 15...................... 11.25.
Clinical Care Subdomain......... 60......................
STrR measure................ 11...................... 8.25.
Dialysis Adequacy measure... 18...................... 13.5.
VAT measure topic........... 18...................... 13.5.
Hypercalcemia measure....... 2....................... 1.5.
SHR measure................. 11...................... 8.25.
-------------------------------------------------------------------------------
Total................... 100% (of Clinical 75% (of TPS).
Measure Domain).
----------------------------------------------------------------------------------------------------------------
Note: The percentages listed in this Table represent the measure weight as a percent of the Clinical Domain
Score for PY 2020.
We are not proposing any changes to these weights finalized in the
CY 2017 ESRD PPS final rule at 81 FR 77918.
6. Proposed Payment Reductions for the PY 2020 ESRD QIP
Section 1881(h)(3)(A)(ii) of the Act requires the Secretary to
ensure that the application of the ESRD QIP scoring methodology results
in an appropriate distribution of payment reductions across facilities,
such that facilities achieving the lowest TPS receive the largest
payment reductions. In the CY 2017 ESRD PPS final rule, we finalized
our proposal for calculating the minimum TPS for PY 2020 and future
payment years (81 FR 77927). Under our current policy, a facility will
not receive a payment reduction if it achieves a minimum TPS that is
equal to or greater than the total of the points it would have received
if: (1) It performs at the performance standard for each clinical
measure; and (2) it receives the number of points for each reporting
measure that corresponds to the 50th percentile of facility performance
on each of the PY 2018 reporting measures (81 FR 77927).
We were unable to calculate a minimum TPS for PY 2020 in the CY
2017 ESRD PPS final rule because we were not yet able to calculate the
performance standards for each of the clinical measures. We therefore
stated that we would publish the minimum TPS for the PY 2020 ESRD QIP
in the CY 2018 ESRD PPS final rule (81 FR 77927).
Based on the estimated performance standards listed above, we
estimate that a facility must meet or exceed a minimum TPS of 61 for PY
2020. For all of the clinical measures, these data come from CY 2015.
We are proposing that a facility failing to meet the minimum TPS, which
we will finalize in the CY 2018 ESRD PPS final rule, will receive a
payment reduction based on the estimated TPS ranges indicated in Table
5.
Table 5--Estimated Payment Reduction Scale for PY 2020 Based on the Most
Recently Available Data
------------------------------------------------------------------------
Reduction
Total performance score (%)
------------------------------------------------------------------------
100-61...................................................... 0
60-51....................................................... 0.5
50-41....................................................... 1.0
40-31....................................................... 1.5
30-21....................................................... 2.0
------------------------------------------------------------------------
7. Data Validation
One of the critical elements of the ESRD QIP's success is ensuring
that the data submitted to calculate measure scores and TPSs are
accurate. We began a pilot data validation program in CY 2013 for the
ESRD QIP, and procured the services of a data validation contractor
that was tasked with validating a national sample of facilities'
records as reported to CROWNWeb. For validation of CY 2014 data, our
priority was to develop a methodology for validating data submitted to
CROWNWeb under the pilot data validation program. That methodology was
fully developed and adopted through the rulemaking process. For the PY
2016 ESRD QIP (78 FR 72223 through 72224), we finalized a requirement
to sample approximately 10 records from 300 randomly selected
facilities; these facilities had 60 days to comply once they received
requests for records. We continued this pilot for the PY 2017, PY 2018
and PY 2019 ESRD QIP, and propose to continue doing so for the PY 2020
ESRD QIP. Using the data collected thus far, we are exploring options
for refining the methodology used in order to improve the effectiveness
and reliability of the data collected. For future payment years, we
will consider whether this validation effort should continue in pilot
status or as a permanent feature of the ESRD QIP program. Under the
continued validation study, we will sample the same number of records
(approximately 10 per facility) from the same number of facilities,
which totaled 300 facilities during CY 2018. If a facility is randomly
selected to participate in the pilot validation study but does not
provide us with the requisite medical records within 60 calendar days
of receiving a request, then we propose to deduct 10 points from the
facility's TPS.
In the CY 2015 ESRD PPS final rule (79 FR 66120 through 66265), we
also finalized that there would be a feasibility study for validating
data reported to CDC's NHSN Dialysis Event Module for the NHSN BSI
Clinical Measure (OMB #0938-NEW). Healthcare-acquired infections are
relatively rare, and we finalized that the feasibility study would
target records with a higher probability of including a dialysis event,
because this would enrich the validation sample while reducing the
burden on facilities. This methodology resembles the methodology we use
in the Hospital Inpatient Quality Reporting Program to validate the
central line-associated BSI measure, the catheter-associated urinary
tract infection measure, and the surgical site infection measure (77 FR
53539 through 53553).
For the PY 2020 ESRD QIP, we propose to continue conducting the
same NHSN dialysis event validation study, that we finalized in the CY
2017 ESRD PPS final rule for PY 2019 (81 FR 77894). For PY 2020, we
would continue to select 35 facilities to participate in an NHSN
dialysis event validation study by submitting 10 patient records
covering two quarters of data reported in CY 2018. However, for PY
2020, the sampling method used to select the 35 facilities would be
adjusted
[[Page 31208]]
such that a more representative sample of facility data can be
analyzed, including data from high performing facilities as well as
facilities identified as being at risk of underreporting. A CMS
contractor would send these facilities requests for medical records for
all patients with ``candidate events'' during the evaluation period;
that is, patients who had any positive blood cultures; received any
intravenous antimicrobials; had any pus, redness, or increased swelling
at a vascular access site; and/or were admitted to a hospital during
the evaluation period. Facilities would have 60 calendar days to
respond to the request for medical records based on candidate events
either electronically or on paper. If the contractor determines that
additional medical records are needed to reach the 10-record threshold
from a facility to validate whether the facility accurately reported
the dialysis events, then the contractor would send a request for
additional, randomly selected patient records from the facility. The
facility would have 60 calendar days from the date of the letter to
respond to the request. With input from CDC, the CMS contractor would
utilize a methodology for reviewing and validating records from
selected patients, in order to determine whether the facility reported
dialysis events for those patients in accordance with the NHSN Dialysis
Event Protocol. If a facility is selected to participate in the
validation study but does not provide CMS with the requisite lists of
information or medical records within 60 calendar days of receiving a
request, then we propose to deduct 10 points from the facility's TPS.
Information from the validation study may be used in future years of
the program to inform our consideration of future policies that would
incorporate NHSN data accuracy into the scoring process. In future
years of the program we may also look to improve the NHSN dialysis
event validation study by validating records from a greater number of
facilities or by validating a larger sample of records from each
facility participating in the study.
E. Proposed Requirements for the PY 2021 ESRD QIP
1. Proposed Measures for the PY 2021 ESRD QIP
We previously finalized 16 measures in the CY 2017 ESRD PPS final
rule for the PY 2020 ESRD QIP. In accordance with our policy to
continue using measures unless we propose to remove or replace them,
(77 FR 67477), we will continue to use all but 2 of these measures in
the PY 2021 ESRD QIP. These measures are summarized in Table 6 below.
We are proposing to replace the two VAT Clinical Measures with the
proposed Hemodialysis Vascular Access: Standardized Fistula Rate
Clinical Measure and the proposed Hemodialysis Vascular Access: Long-
Term Catheter Rate Clinical Measure beginning with PY 2021.
Table 6--PY 2020 ESRD QIP Measures Being Continued in PY 2021
----------------------------------------------------------------------------------------------------------------
NQF No. Measure title and description
----------------------------------------------------------------------------------------------------------------
0258.................................................. ICH CAHPS Survey Administration, a clinical measure.
Measure assesses patients' self-reported experience of
care through percentage of patient responses to
multiple testing tools.
2496.................................................. SRR, a clinical measure. Ratio of the number of observed
unplanned 30-day hospital readmissions to the number of
expected unplanned 30-day readmissions.
2979.................................................. STrR, a clinical measure. Risk-adjusted standardized
transfusion ratio for all adult Medicare dialysis
patients. Number of observed eligible red blood cell
transfusion events occurring in patients dialyzing at a
facility to the number of eligible transfusions that
would be expected.
N/A................................................... Kt/V Dialysis Adequacy Comprehensive, a clinical
measure. Percentage of all patient months for patients
whose delivered dose of dialysis (either hemodialysis
or peritoneal dialysis) met the specified threshold
during the reporting period.
1454.................................................. Hypercalcemia, a clinical measure. Proportion of patient-
months with 3-month rolling average of total
uncorrected serum or plasma calcium greater than 10.2
mg/dL.
1463 *................................................ SHR, a clinical measure. Risk-adjusted SHR of the number
of observed hospitalizations to the number of expected
hospitalizations.
0255.................................................. Serum Phosphorus, a reporting measure. Percentage of all
adult (>=18 years of age) peritoneal dialysis and
hemodialysis patients included in the sample for
analysis with serum or plasma phosphorus measured at
least once within month.
N/A................................................... Anemia Management Reporting, a reporting measure. Number
of months for which facility reports erythropoiesis-
stimulating agent (ESA) dosage (as applicable) and
hemoglobin/hematocrit for each Medicare patient, at
least once per month.
Based on NQF #0420.................................... Pain Assessment and Follow-Up, a reporting measure.
Facility reports in CROWNWeb one of six conditions for
each qualifying patient once before August 1 of the
performance period and once before February 1 of the
year following the performance period.
Based on NQF #0418.................................... Clinical Depression Screening and Follow-Up, a reporting
measure. Facility reports in CROWNWeb one of six
conditions for each qualifying patient once before
February 1 of the year following the performance
period.
Based on NQF #0431.................................... NHSN Healthcare Personnel Influenza Vaccination, a
reporting measure. Facility submits Healthcare
Personnel Influenza Vaccination Summary Report to CDC's
NHSN system, according to the specifications of the
Healthcare Personnel Safety Component Protocol, by May
15 of the performance period.
N/A................................................... Ultrafiltration Rate, a reporting measure. Number of
months for which a facility reports elements required
for ultrafiltration rates for each qualifying patient.
Based on NQF #1460.................................... NHSN BSI in Hemodialysis Patients, a clinical measure.
The Standardized Infection Ratio (SIR) of BSIs will be
calculated among patients receiving hemodialysis at
outpatient hemodialysis centers.
N/A................................................... NHSN Dialysis Event Reporting Measure. Number of months
for which facility reports NHSN Dialysis Event data to
CDC.
----------------------------------------------------------------------------------------------------------------
* We note that the complete lists of ICD-10 codes associated with the Standardized Readmission Ratio Clinical
Measure and the Standardized Hospitalization Ratio Clinical Measure included in the ESRD QIP for PY 2020 are
included in the Measure Technical Reports, available here: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ESRDQIP/061_TechnicalSpecifications.html.
[[Page 31209]]
2. Proposed Replacement of the Vascular Access Type (VAT) Clinical
Measures Beginning With the PY 2021 Program Year
We consider a quality measure for removal or replacement if: (1)
Measure performance among the majority of ESRD facilities is so high
and unvarying that meaningful distinctions in improvements or
performance can no longer be made (in other words, the measure is
topped-out); (2) performance or improvement on a measure does not
result in better or the intended patient outcomes; (3) a measure no
longer aligns with current clinical guidelines or practice; (4) a more
broadly applicable (across settings, populations, or conditions)
measure for the topic becomes available; (5) a measure that is more
proximal in time to desired patient outcomes for the particular topic
becomes available; (6) a measure that is more strongly associated with
desired patient outcomes for the particular topic becomes available; or
(7) collection or public reporting of a measure leads to negative or
unintended consequences (77 FR 67475). In the CY 2015 ESRD PPS final
rule, we adopted statistical criteria for determining whether a
clinical measure is topped out, and adopted a policy under which we
could retain an otherwise topped-out measure if we determined that its
continued inclusion in the ESRD QIP measure set would address the
unique needs of a specific subset of the ESRD population (79 FR 66174).
Subsequent to the publication of the CY 2017 ESRD PPS final rule,
we evaluated the finalized PY 2020 ESRD QIP measures that would be
continued in PY 2021 against all of these criteria. We determined that
none of these measures met criterion (1), (2), (3), (4), (5) or (7). As
part of this evaluation for criterion one, we performed a statistical
analysis of the PY 2020 measures we plan to continue using for PY 2021
and future payment years to determine whether any measures were
``topped out.'' The full results of this analysis can be found at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ESRDQIP/061_TechnicalSpecifications.html and a summary of
our topped-out analysis results appears in Table 7.
As Table 7 illustrates, the distributions of the PY 2020 clinical
measures were assessed in order to determine if any measures were
``topped out.'' In order for a measure to be considered topped out, two
conditions had to be met. First, a measure was considered topped out if
the 75th percentile, or 25th percentile for measures where lower
percentiles indicate better performance, was statistically
indistinguishable from the 90th (or 10th) percentile, and second, the
truncated coefficient of variation (TCV) was less than or equal to 10
percent, or 0.10. We note that the percentiles were considered
statistically indistinguishable if the 75th/25th percentile was within
two standard errors of the 90th/10th percentile. Additionally, for each
measure the TCV was calculated by first removing the lower and upper
5th percentiles, then dividing the standard deviation by the mean of
this truncated distribution (SDtruncated/
Meantruncated). The TCV was then converted to a decimal by
dividing the TCV by 100.
Measures evaluated included the combined Kt/V (that is, a measure
of dialysis adequacy where K is dialyzer clearance, t is dialysis time,
and V is total body water volume measure), Fistula, Catheter,
Hypercalcemia, NHSN Standardized Infection Ratio (SIR), SRR, STrR, SHR,
and the six individual CAHPS clinical measures. Medicare claims data
from 2015 were used in Fistula and Catheter calculations. CROWNWeb data
from 2015 was used for Hypercalcemia, the combination of 2015 CROWNWeb
data and 2015 Medicare claims data were used for Kt/V measure, and the
SRR, STrR, and SHR measures were based on both combination of 2014
CROWNWeb data and 2014 Medicare claims data. The NHSN BSI Clinical
Measure was calculated using the CY 2015 NHSN data from the CDC, and
the six components of the ICH-CAHPS measure were calculated using the
CY 2015 ICH-CAHPS data.
Table 7 presents the percentiles, standard error, and TCV for each
measure. In this analysis, all facilities with the minimum eligible
patient requirement per measure were included. The results indicate
none of the PY 2020 clinical measures met both ``topped out''
conditions.
BILLING CODE 4120-01-P
[[Page 31210]]
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BILLING CODE 4120-01-C
As the information in Table 7 indicates, none of these clinical
measures are currently topped-out in the ESRD QIP. Accordingly, we are
not proposing to remove any of these measures from the ESRD QIP for PY
2021 because they are topped out.
Over the past few years, we have received numerous public comments
regarding the two VAT measures included in the ESRD QIP's measure set.
Specifically, commenters have recommended that CMS adjust the weights
of the VAT measures to place more emphasis on reducing catheters to
encourage the use of fistulas and grafts (81 FR 77904). Another
commenter specifically supported CMS' submission of new VAT Measures to
the NQF Renal Standing Committee to address the small number of
patients for whom a catheter may be the most appropriate vascular
access type when life expectancy is limited (81 FR 77905). We also note
that the VAT measures currently used in the ESRD QIP measure set are
calculated using claims data. This limits the applicability of the
measures to Medicare Fee-For-Service (FFS) patients, while excluding
all others.
Although there is no evidence to suggest that the current VAT
measures are leading to negative or unintended consequences, we are
proposing to
[[Page 31211]]
remove both from the ESRD QIP measure set beginning with the PY 2021
program based on criterion (6) listed earlier, because measures that
are more strongly associated with desired patient outcomes for the
particular topic are now available. As discussed more fully below, we
are proposing to replace the VAT measures with the Proposed
Hemodialysis Vascular Access: Standardized Fistula Rate Clinical
Measure (NQF #2977) and the Proposed Hemodialysis Vascular Access:
Long-Term Catheter Rate Clinical Measure (NQF #2978). These proposed
measures will address the methodological concerns the community has
shared regarding the existing measures. Additionally, they have both
been endorsed by the NQF and are supported by the Measures Application
Partnership. Both of the proposed measures are being considered for
reporting on Dialysis Facility Compare and in the Dialysis Facility
Compare Star Ratings for 2018 and both measures can be calculated using
data that facilities are already required to report in CROWNWeb in
order to meet 42 CFR 494.180(h) of the 2008 updated Conditions for
Coverage for ESRD Dialysis Facilities. Because CROWNWeb collects data
on all patients, we believe that the adoption of these measures will
enable us to more accurately assess the quality of care furnished by
facilities.
We seek comments on our proposal to remove the current VAT measures
from the ESRD QIP measure set beginning with the PY 2021 program year.
3. Proposed Revision of the Standardized Transfusion Ratio (STrR)
Clinical Measure Beginning With the PY 2021 Program Year
We believe that changes during the past several years to the way
ESRD services are reimbursed under Medicare, as well as changes to how
ESRD care is measured under the ESRD QIP and through other quality
reporting initiatives, may have impacted how anemia is clinically
managed. Some of these changes include the identification of safety
concerns associated with aggressive erythropoiesis-stimulating agent
(ESA) use, the expansion of the ESRD PPS bundled payment methodology to
include ESAs, and the continued growth and expansion of the ESRD QIP.
There are concerns that these changes could result in the
underutilization of ESAs, with lower achieved hemoglobin values that
may increase the frequency of red blood cell transfusion in the US
chronic dialysis population.
Excessive rates of blood transfusion may be an indicator for
underutilization of clinical treatments to increase endogenous red
blood cell production (for example, ESA, iron). Dialysis patients who
are eligible for kidney transplant and have received transfusions are
at increased risk of becoming sensitized to the donor pool thereby
making transplant more difficult to accomplish. Blood transfusions
carry a small risk of transmitting blood borne infections and/or the
development of a transfusion reaction, and using infusion centers or
hospitals to transfuse patients is expensive, inconvenient, and could
compromise future vascular access.\6\
---------------------------------------------------------------------------
\6\ FDA Drug Safety Communication: Modified dosing
recommendations to improve the safe use of Erythropoiesis-
Stimulating Agents (ESAs) in chronic kidney disease. https://www.fda.gov/Drugs/DrugSafety/ucm259639.htm.
Kidney Disease: Improving Global Outcome (KDIGO) Anemia Work
Group. KDIGO Clinical Practice Guideline for Anemia in Chronic
Kidney Disease. Kidney inter., Suppl. 2012; 2: 279-335. https://www.kdigo.org/clinical_practice_guidelines/pdf/KDIGO-Anemia%20GL.pdf.
Obrador and Macdougall. Effect of Red Cell Transfusions on
Future Kidney Transplantation. Clin J Am Soc Nephrol 8: 852-860,
2013.
Ibrahim, et al. Blood transfusions in kidney transplant
candidates are common and associated with adverse outcomes. Clin
Transplant 2011: 25: 653-659.
---------------------------------------------------------------------------
Monitoring the risk-adjusted transfusion rate at the dialysis
facility level, relative to national standards, allows for detection of
treatment patterns in dialysis-related anemia management. This is of
particular importance due to recommendations by the Food and Drug
Administration regarding more conservative ESA dosing.\7\ As providers
use less ESAs in an effort to minimize the risks associated with
aggressive anemia treatment, it becomes more important to monitor for
an overreliance on transfusions. Beginning with PY 2017, we adopted the
STrR to address gaps in the quality of anemia management. We also
submitted that measure to the NQF for consensus endorsement, but the
Renal Standing Committee did not recommend it for endorsement, in part
due to concerns that variability in hospital coding practices with
respect to the use of 038 and 039 revenue codes might unduly bias the
measure rates. Upon reviewing the committee's feedback, we revised the
STrR measure to address these concerns. Following this revision, we
resubmitted the STrR (NQF #2979) to NQF for consensus endorsement, and
the NQF endorsed it in 2016. The change we are proposing to the STrR
beginning with the PY 2021 ESRD QIP will align the measure
specifications we use for the ESRD QIP with the measure specifications
that the NQF endorsed in 2016 (NQF #2979).
---------------------------------------------------------------------------
\7\ https://www.fda.gov/Drugs/DrugSafety/ucm259639.htm.
---------------------------------------------------------------------------
Summary of Change
The proposed updated specifications to the STrR measure contain a
more restricted definition of transfusion events than is used in the
current STrR measure. Specifically, the revised definition excludes
inpatient transfusion events for claims that include only 038 or 039
revenue codes without an accompanying ICD-9 or ICD-10 Procedure Code or
Value Code. As a result of requiring that all inpatient transfusion
events include an appropriate ICD-9 or ICD-10 Procedure Code or Value
Code, the measure will identify transfusion events more specifically
and with less bias related to regional coding variation. As a result,
it will assess a smaller number of events as well as a smaller range of
total events.
2016 Measures Application Partnership Review
We determined that the proposed revision to the STrR (NQF #2979)
constituted a substantive change to the measure, and we submitted that
revision to the Measures Application Partnership for consideration as
part of the pre-rulemaking process. The Measures Application
Partnership recommended that this measure be refined and resubmitted
due to concerns that measuring transfusions in dialysis facilities may
not be feasible.\8\ The Measures Application Partnership also expressed
concern that the decision to administer a blood transfusion may be
outside of the dialysis facility's control because in general,
clinicians in hospitals make the decisions about blood transfusions.
The Measures Application Partnership also expressed concern that
variability in blood transfusion coding practices could inadvertently
affect a dialysis facility's performance on this measure.
---------------------------------------------------------------------------
\8\ https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=84452.
---------------------------------------------------------------------------
Although we acknowledge that the Measures Application Partnership
recommended that we refine and resubmit the updated version of the STrR
measure, we note that the Measures Application Partnership's
recommendation is at odds with the earlier conclusion of the NQF to
endorse this change. On the issue of whether it is feasible to measure
transfusions in dialysis facilities, the NQF concluded that these
events can be identified using the same Medicare claims code algorithm
that we use to identify transfusion events in other outpatient
settings. The STrR measure identifies
[[Page 31212]]
transfusion events during at-risk periods for patients cared for in a
dialysis facility.
With respect to the MAP's concern that the decision to administer a
blood transfusion might be outside of the dialysis facility's control,
we note that the issue of whether anemia management practices in a
dialysis facility can be linked to transfusion risk was specifically
considered by the NQF during the endorsement process.
The NQF Renal Standing Committee concluded that this transfusion
avoidance measure would incentivize facilities to properly manage
anemia, with the result of lowering the patient's transfusion risk. The
NQF Renal Standing Committee also found that although the decision to
transfuse might ultimately be made by a hospital, the need to do so is
dictated not only by clinical circumstances observed by the hospital,
but also by the way the patient's anemia was managed by the facility.
Although the Measures Application Partnership was concerned that
variability in blood transfusion coding practices could inadvertently
affect a dialysis facility's performance on this measure, we note that
the definition of transfusion events used in the revised STrR measure
is consistent with the definition used in numerous scientific
publications, including several peer reviewed publications.\9\ Under
this definition, transfusion events are included in the measure only if
they are coded with specific transfusion procedure or value codes. We
believe this coding requirement reduces the potential for inadvertently
capturing non-transfusion events in the measure. In addition, the
exclusion of revenue code only transfusion events from the measure
decreases the potential that the measure results would be influenced by
differences in hospital coding practices.
---------------------------------------------------------------------------
\9\ Hirth, Turenne, Wilk et al. Blood transfusion practices in
dialysis patients in a dynamic regulatory environment. Am J Kidney
Dis. 2014 Oct;64(4):616-21. Doi: 10.1053/j.ajkd.2014.01.011. Epub
2014 Feb 19.
Gilbertson, Monda, Bradbury & Collins. RBC Transfusions Among
Hemodialysis Patients (1999-2010): Influence of Hemoglobin
Concentrations Below 10 g/dL. Am J Kidney Dis. 2013; Volume 62,
Issue 5, 919-928.
Collins et al. Effect of Facility-Level Hemoglobin Concentration
on Dialysis Patient Risk of Transfusion. Am J Kidney Dis. 2014;
63(6):997-1006.
Cappell et al. Red blood cell (RBC) transfusion rates among US
chronic dialysis patients during changes to Medicare end-stage renal
disease (ESRD) reimbursement systems and erythropoiesis stimulating
agent (ESA) labels. BMC Nephrology 2014, 15:116.
Ibrahim, et al. Blood transfusions in kidney transplant
candidates are common and associated with adverse outcomes. Clin
Transplant 2011: 25: 653-659.
Molony, et al. Effects of epoetin alfa titration practices,
implemented after changes to product labeling, on hemoglobin levels,
transfusion use, and hospitalization rates. Am J Kidney Dis 2016:
epub before print (published online March 12, 2016).
---------------------------------------------------------------------------
We agree with the NQF Standing Committee's assessment that the STrR
(NQF #2979) is an appropriate measure of quality for dialysis
facilities. We further believe that the measure is appropriate for the
ESRD QIP because the measure (1) demonstrates variation in performance
among facilities, (2) is an outcome of care that is modifiable by
dialysis providers through effective management of anemia in patients,
and (3) is a valid and reliable indicator of quality at the facility
level. Proper management of anemia is an important quality of care
issue for dialysis patients, and a topic for which the ESRD QIP must
include measures (see section 1881(h)(2)(A)(i)).
For these reasons, we believe the revision to the STrR measure
should be reflected in the ESRD QIP, and beginning with the PY 2021
program year, we propose to use the updated version of the STrR (NQF
#2979). Full measure specifications and testing data are available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ESRDQIP/061_TechnicalSpecifications.html.
We note that the complete list of ICD-10 codes that would be
included in the measure is included in the Technical Report for the
measure, provided at the link listed above.
We seek comments on this proposal.
4. Proposed New Vascular Access Measures Beginning With the PY 2021
ESRD QIP
As discussed in sections IV.E.4, IV.E.4.a, and IV.E.4.b of this
proposed rule, for PY 2021, we propose to remove the two VAT measures
from the ESRD QIP and to replace them with two Vascular Access measures
that were recently endorsed by the NQF. We are proposing to score these
measures the same way that we score the current VAT measures, and to
include them within the Vascular Access Measure Topic.
Background
Beginning with the PY 2015 ESRD QIP, we adopted the Minimizing
Catheter Use as Chronic Dialysis Access (NQF #0256) and Maximizing
Placement of Arterial Venous (AV) fistula (NQF #0257), paired measures
of the rate of catheter and fistula placement for chronic dialysis
access, respectively, for the ESRD QIP (77 FR 67479). These measures
were developed in accordance with the National Kidney Foundation Kidney
Disease Outcomes Quality Initiative Guidelines that state the
following: (1) AV fistulas have the lowest rate of thrombosis and
require the fewest interventions, (2) cost of AV fistula use and
maintenance is the lowest, (3) fistulas have the lowest rates of
infection, and (4) fistulas are associated with the highest survival
and lowest hospitalization rates. A number of epidemiologic studies
consistently demonstrate the reduced morbidity and mortality associated
with greater use of AV fistulas for vascular access in maintenance
hemodialysis.
Based upon data we collected during the CMS Fistula First/Catheter
Last Initiative,\10\ a gradual trend towards lower catheter use has
been observed among prevalent maintenance hemodialysis patients in the
United States, declining from approximately 28 percent in 2006 to
approximately 18 percent by August 2015. Furthermore, the percentage of
maintenance HD patients using a catheter for at least 3 months has
declined during this time period from nearly 12 percent to 10.8
percent. Continued monitoring of chronic catheter use is needed to
sustain this trend.
---------------------------------------------------------------------------
\10\ Fistula First Catheter Last Dashboard August 2015 https://fistulafirst.esrdncc.org/ffcl/for-ffcl-professionals/archive/.
---------------------------------------------------------------------------
Since the Maximizing Placement of AV fistula (NQF #0257) was first
implemented, we have received public comments expressing concerns that
in certain cases, such as patients with a low life expectancy,
placement of a fistula may not be appropriate. A growing number of
studies report that creating AV fistulas in some patients is less
likely to be successful in the presence of certain comorbidities. In
addition, certain patient groups may have less incremental benefit from
an AV fistula relative to an AV graft.
Since the implementation of Minimizing Catheter Use as Chronic
Dialysis Access (NQF #0256), we have received comments from
stakeholders raising concerns about its inability to account for
patients with a limited life expectancy, for whom a fistula, with its
extended maturation period, may not represent an improved quality of
life. By incorporating additional exclusion criteria to account for
such patients, this measure avoids setting a quality standard that may
penalize facilities for providing appropriate vascular access.
In 2015, we convened a Technical Expert Panel (TEP) to review the
existing vascular access measures to consider how best to address these
concerns. A copy of the summary TEP report is available at https://
www.cms.gov/Medicare/Quality-
[[Page 31213]]
Initiatives-Patient-Assessment-Instruments/ESRDQIP/
061_TechnicalSpecifications.html. The TEP made the following
recommendations:
The fistula measure should be risk-adjusted for factors
that are associated with decreased likelihood of AV fistula success,
including:
++ Diabetes.
++ Heart diseases.
++ Peripheral vascular disease.
++ Cerebrovascular disease.
++ Chronic obstructive pulmonary disease.
++ Anemia (unrelated to ESRD/Chronic Kidney Disease).
++ Non-Vascular Access-Related Infections.
++ Drug Dependence.
The measures should include all eligible hemodialysis
patients, not just Medicare beneficiaries.
The measures should include patients in the first 90 days
of dialysis because this is a critical time for access planning/
placement.
The measures should include in the numerator only patients
with an AV fistula using 2 needles (or an approved single needle
device).
The measures should exclude conditions associated with a
limited life expectancy where an AV fistula may not be the appropriate
choice for access (for example, hospice, metastatic cancer, end stage
liver disease, and coma/brain injury).
We responded to the TEP's recommendations by developing two new VAT
measures intended to be jointly reported to assess the placement of
vascular access among ESRD dialysis patients. These two vascular access
quality measures, when used together, consider AV fistula use as a
positive outcome and prolonged use of a tunneled catheter as a negative
outcome. With the growing recognition that some patients have exhausted
options for an AV fistula or have comorbidities that may limit the
success of AV fistula creation, joint reporting of the measures
accounts for all three vascular access options. This paired incentive
structure that relies on both measures (standardized fistula rate and
long-term catheter rate) reflects consensus-based best practice, and
supports maintenance of the gains in vascular access success achieved
via the Fistula First/Catheter Last Project over the last decade.
a. Proposed New Hemodialysis Vascular Access: Standardized Fistula Rate
Clinical Measure (NQF #2977)
Summary of Changes
This proposed measure replaces NQF #0257, Maximizing Placement of
AV fistula, and it incorporates changes that reflect input from the
2015 Vascular Access TEP:
Risk Adjustment for the following conditions that affect
the success of fistula placement:
++ Diabetes.
++ Heart diseases.
++ Peripheral vascular disease.
++ Cerebrovascular disease.
++ Chronic obstructive pulmonary disease.
++ Anemia (unrelated to ESRD/Chronic Kidney Disease).
++ Non-Vascular Access-Related Infections.
++ Drug Dependence.
Inclusion of all eligible hemodialysis patients, not just
Medicare beneficiaries.
Inclusion of patients in the first 90 days of dialysis
because this is a critical time for access planning/placement.
Inclusion in the numerator of only patients with an AV
fistula using 2 needles (or an approved single needle device).
Exclusion of conditions associated with a limited life
expectancy where an AV fistula may not be the appropriate choice for
access (for example, hospice, metastatic cancer, end-stage liver
disease, and coma/brain injury).
Data Sources
CROWNWeb, Medicare claims and the CMS Medical Evidence form 2728
(OMB No. 0938-0046) are used as the data sources for establishing the
denominator. CROWNWeb is the data source for establishing the
numerator. Medicare claims and the CMS Medical Evidence form 2728 are
data sources for the risk adjustment factors. Medicare claims and
CROWNWeb are used for the exclusion criteria. Using CROWNWeb as the
primary data source allows us to expand the Standardized Fistula Rate
to include all ESRD dialysis patients, rather than only Medicare FFS
patients, providing a more complete quality assessment for dialysis
facilities. This was a key consideration by the TEP that recommended
the development of this measure.
Outcome
The outcome of the Standardized Fistula Rate is the use of an AV
fistula as the sole means of vascular access as of the last
hemodialysis treatment session of the month.
Cohort
The cohort includes adult ESRD dialysis patients who are determined
to be maintenance hemodialysis patients (in-center or home) for the
entire reporting month at the same facility.
Inclusion and Exclusion Criteria
The Standardized Fistula Rate excludes pediatric patients (<18
years old), patients on peritoneal dialysis, and patient-months where
the patient was not on hemodialysis (in-center or home) at the same
facility for the entire reporting month. The measure additionally
excludes patients with a catheter who have a limited life expectancy.
Risk Adjustment
The Standardized Fistula Rate is a directly standardized
percentage, with each facility's percentage of fistula use adjusted by
a series of risk factors, including patient demographic and clinical
characteristics based on a logistic regression model. The demographic
and clinical characteristics were chosen in order to adjust for factors
outside the control of a facility that are associated with a decreased
likelihood of AV fistula success.
We submitted the measure to NQF, where the Renal Standing Committee
recommended it for consensus endorsement, and the NQF endorsed the
measure in December 2016. The Standardized Fistula Rate (NQF #2977) was
submitted to the Measure Applications Partnership in 2016, which
supported the measure for implementation in the ESRD QIP.
We propose implementing Hemodialysis Vascular Access: Standardized
Fistula Rate (NQF #2977) beginning with the PY 2021 program year.
Detailed measure specifications and testing data are available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ESRDQIP/061_TechnicalSpecifications.html. We seek comments
on this proposal.
b. Proposed New Hemodialysis Vascular Access: Long-Term Catheter Rate
(NQF #2978) Beginning With the PY 2021 ESRD QIP
Summary of Changes
This proposed measure replaces NQF #0256, Minimizing Use of
Catheters as Chronic Dialysis Access, and it incorporates the following
changes that reflect input from the 2015 Vascular Access TEP:
Inclusion of all eligible hemodialysis patients, not just
Medicare beneficiaries, since the measure is now specified to be
calculated from CROWNWeb.
Patients using a catheter continuously for 3 months or
longer, even if combined with an AV fistula (or graft), are now counted
in the numerator. The current measure does
[[Page 31214]]
not count patients in the numerator if they have a catheter combined
with an AV fistula or graft.
Patients with missing VAT are counted in both the
denominator and the numerator. That is, ``missing'' access type is
considered a ``failure'' and therefore counts against the facility.
Exclusion criteria have been added to the measure for
conditions associated with a limited life expectancy where a catheter
may be an appropriate choice for access. These are the same exclusions
applied to the Standardized Fistula Rate measure (for example, hospice,
metastatic cancer, end stage liver disease, and coma/brain injury).
Data Sources
CROWNWeb, Medicare Claims and the CMS Medical Evidence form 2728
are used as the data sources for establishing the denominator. CROWNWeb
is the data source for establishing the numerator. Medicare claims and
CROWNWeb are used for the exclusion criteria. Medicare claims and the
CMS Medical Evidence Form 2728 are used for risk adjustment. Using
CROWNWeb as the primary data source allows us to expand the Long-Term
Catheter Rate to include all ESRD dialysis patients, rather than only
Medicare FFS patients, providing a more complete quality assessment for
dialysis facilities. This was a key consideration by the TEP that
recommended the development of this measure.
Outcome
The outcome of the Long-Term Catheter Rate is the use of a catheter
continuously for 3 months or longer as of the last hemodialysis
treatment session of the month.
Cohort
The cohort includes adult ESRD dialysis patients who are determined
to be maintenance hemodialysis patients (in-center or home) for the
entire reporting month at the same facility.
Inclusion and Exclusion Criteria
The Long-Term Catheter Rate excludes pediatric patients (<18 years
old), patients on peritoneal dialysis, and patient-months not on
hemodialysis (in-center or home) for the entire reporting month at the
same facility. The measure additionally excludes patients with a
catheter who have a limited life expectancy.
We submitted the Long-Term Catheter Rate (NQF #2978) to NQF, where
the Renal Standing Committee recommended it for consensus endorsement,
and the NQF endorsed the measure in December 2016. The measure was
submitted to the Measure Application Partnership in 2016, which
supported it for implementation in the ESRD QIP.
We propose to introduce the Long-Term Catheter Rate (NQF #2978)
into the ESRD QIP beginning with the PY 2021 program year. Full measure
specifications and testing data are available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ESRDQIP/061_TechnicalSpecifications.html.
We seek comments on this proposal.
5. Proposed Performance Period for the PY 2021 ESRD QIP
We are proposing to establish CY 2019 as the performance period for
the PY 2021 ESRD QIP for all but the NHSN Healthcare Personnel
Influenza Vaccination reporting measure because it is consistent with
the performance periods we have historically used for these measures
and accounts for seasonal variations that might affect a facility's
measure score.
We are proposing that the performance period for the NHSN
Healthcare Personnel Influenza Vaccination reporting measure will be
from October 1, 2018 through March 31, 2019, because this period spans
the length of the 2018-2019 influenza season.
We seek comments on these proposals.
6. Proposed Performance Standards, Achievement Thresholds, and
Benchmarks for the PY 2021 ESRD QIP
Section 1881(h)(4)(A) of the Act provides that ``the Secretary
shall establish performance standards with respect to measures selected
. . . for a performance period with respect to a year.'' Section
1881(h)(4)(B) of the Act further provides that the ``performance
standards . . . shall include levels of achievement and improvement, as
determined appropriate by the Secretary.'' We use the performance
standards to establish the minimum score a facility must achieve to
avoid a Medicare payment reduction.
a. Proposed Performance Standards, Achievement Thresholds, and
Benchmarks for the Clinical Measures in the PY 2021 ESRD QIP
For the same reasons stated in the CY 2013 ESRD PPS final rule (77
FR 67500 through 76502), we are proposing for PY 2021 to set the
performance standards, achievement thresholds, and benchmarks for the
clinical measures at the 50th, 15th, and 90th percentile, respectively,
of national performance in CY 2017, because this will give us enough
time to calculate and assign numerical values to the proposed
performance standards for the PY 2021 program prior to the beginning of
the performance period. We continue to believe these standards will
provide an incentive for facilities to continuously improve their
performance, while not reducing incentives to facilities that score at
or above the national performance rate for the clinical measures.
We seek comments on our proposal to continue this policy for PY
2021.
b. Performance Standards, Achievement Thresholds, and Benchmarks for
the Clinical Measures Proposed for the PY 2021 ESRD QIP
At this time, we do not have the necessary data to assign numerical
values to the proposed performance standards for the clinical measures,
because we do not yet have data from CY 2017 or the first portion of CY
2018. We will publish values for the clinical measures, using data from
CY 2017 and the first portion of CY 2018 in the CY 2019 ESRD PPS final
rule.
c. Proposed Performance Standards for the PY 2021 Reporting Measures
In the CY 2014 ESRD PPS final rule, we finalized performance
standards for the Anemia Management and Mineral Metabolism reporting
measures (78 FR 72213). In the CY 2016 ESRD PPS final rule, we
finalized performance standards for the Screening for Clinical
Depression and Follow-Up, Pain Assessment and Follow-Up, and NHSN
Healthcare Provider Influenza Vaccination reporting measures (79 FR
66209). In the CY 2017 ESRD PPS final rule, we finalized performance
standards for the Ultrafiltration Rate Reporting Measure (81 FR 77916),
the Serum Phosphorus Reporting measure (81 FR 77916), and the NHSN
Dialysis Event Reporting measure (81 FR 77916).
We are proposing to continue use of these performance standards for
the Reporting Measures included in the PY 2021 ESRD QIP.
7. Proposal for Scoring the PY 2021 ESRD QIP
a. Scoring Facility Performance on Clinical Measures Based on
Achievement
In the CY 2014 ESRD PPS final rule, we finalized a policy for
scoring performance on clinical measures based on achievement (78 FR
72215). Under this methodology, facilities receive points along an
achievement range based on their performance during the performance
period for each measure,
[[Page 31215]]
which we define as a scale between the achievement threshold and the
benchmark. In determining a facility's achievement score for each
clinical measure under the PY 2021 ESRD QIP, we propose to continue
using this methodology for all clinical measures.
We also propose to use this same methodology for scoring the two
new Vascular Access measures proposed in sections IV.E.4.a and
IV.E.4.b.
Aside from the proposed addition of the two Vascular Access
measures, we are not proposing any changes to this policy. We propose
to continue use of this policy for the PY 2021 ESRD QIP.
b. Proposal for Scoring Facility Performance on Clinical Measures Based
on Improvement
In the CY 2014 ESRD PPS final rule, we finalized a policy for
scoring performance on clinical measures based on improvement (78 FR
72215 through 72216). In determining a facility's improvement score for
each measure under the PY 2021 ESRD QIP, we propose to continue using
this methodology for all clinical measures. Under this methodology,
facilities receive points along an improvement range, defined as a
scale running between the improvement threshold and the benchmark. We
propose to define the improvement threshold as the facility's
performance on the measure during CY 2018. The facility's improvement
score would be calculated by comparing its performance on the measure
during CY 2019 (the proposed performance period) to the improvement
threshold and benchmark.
We also propose to use this same methodology for scoring the two
new Vascular Access measures proposed in sections IV.E.4.a and IV.E.b.
Aside from the proposed addition of the two new Vascular Access
measures, we are not proposing any changes to this policy. We propose
to continue use of this policy for the PY 2021 ESRD QIP.
c. Scoring the ICH CAHPS Clinical Measure
In the CY 2015 ESRD PPS final rule, we finalized a policy for
scoring performance on the ICH CAHPS clinical measure based on both
achievement and improvement (79 FR 66209 through 66210). We are
proposing to use this scoring methodology for the PY 2021 ESRD QIP.
Under this methodology, facilities will receive an achievement score
and an improvement score for each of the three composite measures and
three global ratings in the ICH CAHPS survey instrument. A facility's
ICH CAHPS score will be based on the higher of the facility's
achievement or improvement score for each of the composite measures and
global ratings, and the resulting scores on each of the composite
measures and global ratings will be averaged together to yield an
overall score on the ICH CAHPS clinical measure. For PY 2021, the
facility's achievement score would be calculated by comparing where its
performance, on each of the three composite measures and three global
ratings during CY 2019, falls relative to the achievement threshold and
benchmark for that measure and rating based on CY 2017 data. The
facility's improvement score would be calculated by comparing its
performance on each of the three composite measures and three global
ratings during CY 2019 to its performance rates on these items during
CY 2018.
We seek comments on this proposal.
d. Proposal for Scoring the Proposed Hemodialysis Vascular Access:
Standardized Fistula Rate and Long-Term Catheter Rate Measures and the
Vascular Access Measure Topic
In the CY 2013 ESRD PPS final rule we established a methodology for
deriving the overall scores for measure topics (77 FR 67507). We are
proposing to use the same methodology described in the CY 2013 ESRD PPS
to calculate the VAT Measure Topic Score.
We seek comments on this proposal.
e. Proposal for Calculating Facility Performance on Reporting Measures
In the CY 2013 ESRD PPS final rule, we finalized policies for
scoring performance on the Anemia Management and Mineral Metabolism
reporting measures in the ESRD QIP (77 FR 67506). In the CY 2015 ESRD
PPS final rule, we finalized policies for scoring performance on the
Clinical Depression Screening and Follow-Up, Pain Assessment and
Follow-Up, and NHSN Healthcare Provider Influenza Vaccination reporting
measures (79 FR 66210 through 66211). In the CY 2017 ESRD PPS final
rule, we finalized policies for scoring performance on the
Ultrafiltration Rate, Serum Phosphorus, and NHSN Dialysis Event
reporting measures (81 FR 77917).
We propose to continue use of these policies for the PY 2021 ESRD
QIP.
8. Proposal for Weighting the Clinical Measure Domain, and Weighting
the TPS
a. Proposal for Weighting the Clinical Measure Domain for PY 2021
In the CY 2017 ESRD PPS final rule, we discussed our policy
priorities for quality improvement for patients with ESRD (81 FR
77887). These priorities have not changed since that time. Accordingly,
in an effort to remain consistent in the weighting of measures included
in the program, we propose to weight the following measures in the
following subdomains of the clinical measure domain (see Table 8):
Table 8--Proposed Measure Domain Weighting for the PY 2021 ESRD QIP
------------------------------------------------------------------------
Measure weight
within the Measure weight
Measures/measure topics by subdomain domain as percent of
(proposed for TPS (proposed
PY 2021) (%) for PY 2021)
------------------------------------------------------------------------
Clinical Measure Domain
------------------------------------------------------------------------
Patient and Family Engagement/Care 40 30
Coordination Subdomain.................
ICH CAHPS Measure................... 25 18.75
SRR Measure......................... 15 11.25
Clinical Care Subdomain................. 60 45
STrR measure........................ 11 8.25
Kt/V Dialysis Adequacy Comprehensive 18 13.5
Measure............................
Vascular Access Type Measure Topic.. 18 13.5
Hypercalcemia measure............... 2 1.5
SHR Measure......................... 11 8.25
-------------------------------
[[Page 31216]]
Total: Clinical Measure Domain...... 100% of 75% of Total
Clinical Performance
Measure Domain Score.
------------------------------------------------------------------------
Reporting Measure Domain
------------------------------------------------------------------------
Serum Phosphorus reporting measure...... 20 2
Anemia Management reporting measure..... 20 2
Pain Assessment and Follow-Up reporting 20 2
measure................................
Clinical Depression Screening and Follow- 20 2
Up reporting measure...................
NHSN HCP Influenza Vaccination reporting 20 2
measure................................
-------------------------------
Total: Reporting Measure Domain..... 100% of 10% of Total
Reporting Performance
Measure Domain Score.
------------------------------------------------------------------------
Safety Measure Domain
------------------------------------------------------------------------
NHSN BSI Clinical Measure............... 60 9
NHSN Dialysis Event Reporting Measure... 40 6
-------------------------------
Total: Safety Measure Domain........ 100% of Safety 15% of Total
Measure Domain Performance
Score.
------------------------------------------------------------------------
Specifically, for PY 2021 we are proposing to maintain the weight
of the Safety Measure Domain at 15 percent of a facility's TPS without
raising it further, in light of validation concerns discussed in the CY
2017 ESRD PPS final rule (81 FR 77887). Specifically, we identified two
distinct types of accidental or intentional under-reporting. First,
there is a belief that many facilities do not consistently report
monthly dialysis event data for the full 12-month performance period.
Second, even with respect to the facilities that do report monthly
dialysis event data, there is a concern that many of those facilities
do not consistently report all of the dialysis events that they should
be reporting (81 FR 77879). Additionally, as discussed above, although
we are not proposing to change the total number of measures in the ESRD
QIP's measure set for PY 2021, we are proposing to replace the existing
Vascular Access measures with the proposed Standardized Fistula and
Catheter Clinical measures. We believe these measures hold the same
importance and value as the measures they are replacing and are
therefore not proposing any changes to the weights finalized for PY
2020 in the CY 2017 ESRD PPS final rule. We may, in future years of the
program, consider increasing the weight of the NHSN BSI Clinical
Measure and/or the NHSN BSI Measure Topic once we see that facilities
are completely and accurately reporting to NHSN and once we have
analyzed the data from the recently increased NHSN Data Validation
Study.
We seek comments on these proposals.
b. Proposal for Weighting the Domains Used To Calculate the TPS
We continue to believe that while the reporting measures are
valuable, the clinical measures assess facility performance on actual
patient care processes and outcomes and therefore justify a higher
combined weight (78 FR 72217). In the CY 2017 ESRD PPS final rule, we
finalized that the weight of the Safety Measure Domain would be 15
percent of a facility's TPS, the weight of the Clinical Measure Domain
would be 75 percent of a facility's TPS and the weight of the Reporting
Measure Domain would be 10 percent of a facility's TPS. We are not
proposing any changes to this and are proposing to apply it to the PY
2021 program year.
In the CY 2017 ESRD PPS final rule, we finalized that, to be
eligible to receive a TPS, a facility must be eligible to be scored on
at least one measure in the Clinical Measure Domain and at least one
measure in the Reporting Measure Domain. We are not proposing any
changes to this policy for the PY 2021 ESRD QIP.
We seek comments on the continued use of these policies.
9. Example of the Proposed PY 2021 ESRD QIP Scoring Methodology
In this section, we provide an example to illustrate the proposed
scoring methodology for PY 2021. Figures 1 through 4 illustrate how to
calculate the Clinical Measure Domain score, the Reporting Measure
Domain score, the Safety Measure Domain score, and the TPS. Figure 5
illustrates the full proposed scoring methodology for PY 2021. Note
that for this example, Facility A, a hypothetical facility, has
performed very well.
Figure 1 illustrates the methodology used to calculate the Clinical
Measure Domain score for Facility A.
[[Page 31217]]
[GRAPHIC] [TIFF OMITTED] TP05JY17.002
Figure 2 illustrates the general methodology for calculating the
Reporting Measure Domain score for Facility A.
[[Page 31218]]
[GRAPHIC] [TIFF OMITTED] TP05JY17.003
Figure 3 illustrates the methodology used for calculating the
Safety Measure Domain score for Facility A.
[[Page 31219]]
[GRAPHIC] [TIFF OMITTED] TP05JY17.004
Figure 4 illustrates the methodology used to calculate the TPS for
Facility A.
[[Page 31220]]
[GRAPHIC] [TIFF OMITTED] TP05JY17.005
Figure 5 illustrates the full scoring methodology for PY 2021.
[[Page 31221]]
[GRAPHIC] [TIFF OMITTED] TP05JY17.006
10. Proposed Minimum Data for Scoring Measures for the PY 2021 ESRD QIP
Our policy is to score facilities on clinical and reporting
measures for which they have a minimum number of qualifying patients
during the performance period. With the exception of the Standardized
Readmission Ratio, Standardized Hospitalization Ratio, Standardized
Transfusion Ratio, NHSN Healthcare Personnel Influenza Vaccination, and
ICH CAHPS clinical measures, a facility must treat at least 11
qualifying cases during the performance period in order to be scored on
a clinical or reporting measure. A facility must have at least 11 index
discharges to be eligible to receive a score on the SRR clinical
measure, 10 patient-years at risk to be eligible to receive a score on
the STrR clinical measure, and 5 patient-years at risk to be eligible
to receive a score on the SHR clinical measure. The NHSN Healthcare
Personnel Influenza Vaccination measure does not assess patient level
data and therefore does not have a minimum qualifying patient count. In
order to receive a score on the ICH CAHPS clinical measure, a facility
must have treated at least 30 survey-eligible patients during the
eligibility period and receive 30 completed surveys during the
performance period. We propose to continue use of these minimum data
policies for the measures that we have proposed to continue including
in the PY 2021 ESRD QIP measure set. Additionally, we propose to use
these same minimum data policies for the proposed Vascular Access
Measures discussed above.
Under our current policy, we begin counting the number of months
for which a facility is open on the first day of the month after the
facility's CMS Certification Number (CCN) Open Date. In section IV.D.1
of the preamble, we proposed clarifications to our CCN Open Date Policy
and to the patient minimum requirements for each of the measures
finalized for the PY 2020 ESRD QIP. For the PY 2021 ESRD QIP, only
facilities with a CCN Open Date before July 1, 2019 would be eligible
to be scored on the Anemia Management, Serum Phosphorous,
Ultrafiltration Rate, Pain Assessment and Follow-Up, Clinical
Depression Screening and Follow-Up reporting measures, and only
facilities with a CCN Open Date before January 1, 2019 would be
eligible to be scored on the NHSN BSI Clinical and Reporting Measures,
the ICH CAHPS Clinical Measure, and the NHSN Healthcare Personnel
Influenza Vaccination reporting measure. We propose to continue
applying these CCN open date policies to the measures proposed for PY
2021.
Table 9 displays the proposed patient minimum requirements for each
of the measures, as well as the proposed CCN Open Dates after which a
facility would not be eligible to receive a score on a reporting
measure. We note that the 11 qualifying patient minimum used for the
majority of the measures shown in the table below is a long-standing
policy in the ERSD QIP.
Table 9--Proposed Minimum Data Requirements for the PY 2021 ESRD QIP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Minimum data
Measure requirements CCN open date Small facility adjuster
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dialysis Adequacy (Clinical).......... 11 qualifying patients.. N/A....................................... 11-25 qualifying patients.
[[Page 31222]]
Hemodialysis Vascular Access: 11 qualifying patients.. N/A....................................... 11-25 qualifying patients.
Standardized Fistula Rate (Clinical).
Hemodialysis Vascular Access: 11 qualifying patients.. N/A....................................... 11-25 qualifying patients.
Standardized Catheter Rate (Clinical).
Hypercalcemia (Clinical).............. 11 qualifying patients.. N/A....................................... 11-25 qualifying patients.
NHSN BSI (Clinical)................... * 11 qualifying patients Before January 1, 2019.................... 11-25 qualifying patients.
NHSN Dialysis Event (Reporting)....... * 11 qualifying patients Before January 1, 2019.................... N/A.
SRR (Clinical)........................ 11 index discharges..... N/A....................................... 11-41 index discharges.
STrR (Clinical)....................... 10 patient-years at risk N/A....................................... 10-21 patient-years at risk.
SHR (Clinical)........................ 5 patient-years at risk. N/A....................................... 5-14 patient-years at risk.
ICH CAHPS (Clinical).................. Facilities with 30 or Before January 1, 2019.................... N/A.
more survey-eligible
patients during the CY
preceding the
performance period must
submit survey results.
Facilities will not
receive a score if they
do not obtain a total
of at least 30
completed surveys
during the performance
period.
Anemia Management (Reporting)......... 11 qualifying patients.. Before July 1, 2019....................... N/A.
Serum Phosphorus (Reporting).......... 11 qualifying patients.. Before July 1, 2019....................... N/A.
Depression Screening and Follow-Up 11 qualifying patients.. Before July 1, 2019....................... N/A.
(Reporting).
Pain Assessment and Follow-Up 11 qualifying patients.. Before July 1, 2019....................... N/A.
(Reporting).
NHSN Healthcare Personnel Influenza N/A..................... Before January 1, 2019.................... N/A.
Vaccination (Reporting).
Ultrafiltration Rate (Reporting)...... 11 qualifying patients.. Before July 1, 2019....................... N/A.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* For the NHSN BSI Clinical Measure and the NHSN Dialysis Event Reporting Measure, qualifying patients include only in-center hemodialysis patients.
Inpatient hemodialysis patients and home hemodialysis or peritoneal dialysis patients are excluded from this measure.
11. Proposed Payment Reductions for the PY 2021 ESRD QIP
Section 1881(h)(3)(A)(ii) of the Act requires the Secretary to
ensure that the application of the scoring methodology results in an
appropriate distribution of payment reductions across facilities, such
that facilities achieving the lowest TPSs receive the largest payment
reductions. We propose that, for the PY 2021 ESRD QIP, a facility will
not receive a payment reduction if it achieves a minimum TPS that is
equal to or greater than the total of the points it would have received
if:
It performed at the performance standard for each clinical
measure.
It received the number of points for each reporting
measure that corresponds to the 50th percentile of facility performance
on each of the PY 2019 reporting measures. We note this proposed policy
for PY 2021 is identical to the policy finalized for PY 2020.
We recognize that we are not proposing a policy regarding the
inclusion of measures for which we are not able to establish a
numerical value for the performance standard through the rulemaking
process before the beginning of the performance period in the PY 2020
minimum TPS. We have not proposed such a policy because no measures in
the proposed PY 2021 measure set meet this criterion. However, should
we choose to adopt a clinical measure in future rulemaking without the
baseline data required to calculate a performance standard before the
beginning of the performance period, we will propose a criterion
accounting for that measure in the minimum TPS for the applicable
payment year at that time.
The PY 2019 program is the most recent year for which we will have
calculated final measure scores before the beginning of the proposed
performance period for PY 2021 (that is, CY 2019). Because we have not
yet calculated final measure scores, we are unable to determine the
50th percentile of facility performance on the PY 2019 reporting
measures. We will publish that value once we have calculated final
measure scores for the PY 2019 program.
Section 1881(h)(3)(A)(ii) of the Act requires that facilities
achieving the lowest TPSs receive the largest payment reductions. In
the CY 2014 ESRD PPS final rule (78 FR 72223 through 72224), we
finalized a payment reduction scale for PY 2016 and future payment
years: For every 10 points a facility falls below the minimum TPS, the
facility would receive an additional 0.5 percent reduction on its ESRD
PPS payments for PY 2016 and future payment years, with a maximum
reduction of 2.0 percent. We are not proposing any changes to this
policy for the PY 2021 ESRD QIP.
Because we are not yet able to calculate the performance standards
for each of the clinical measures, we are also not able to calculate a
proposed minimum TPS at this time. We will propose a minimum TPS, based
on data from CY 2017 and the first part of CY 2018, in the CY 2019 ESRD
PPS proposed rule.
We are not proposing any changes to these policies.
V. Advancing Health Information Exchange
HHS has a number of initiatives designed to improve health and
health care quality through the adoption of health information
technology (health IT) and nationwide health information exchange.
Health IT facilitates the secure, efficient, and effective sharing and
use of health-related information when and where it is needed, and is
an important tool for settings across the continuum of care, including
ESRD facilities. Health IT plays an important role in developing care
plans to manage dialysis related care and co-morbid conditions for
patients with ESRD, as well as enabling electronic coordination and
communication among multidisciplinary teams. Such tools can promote
quality improvement, improve
[[Page 31223]]
efficiencies and reduce unnecessary costs.
HHS continues to make important strides promoting the availability
of technology tools to support providers, including those in ESRD
settings. For instance, the Office of the National Coordinator for
Health Information Technology (ONC) released a document entitled
``Connecting Health and Care for the Nation: A Shared Nationwide
Interoperability Roadmap Version 1.0 (Roadmap) (available at https://www.healthit.gov/sites/default/files/hie-interoperability/nationwide-interoperability-roadmap-final-version-1.0.pdf), which describes
barriers to interoperability across the current health IT landscape,
the desired future state that the industry believes will be necessary
to enable a learning health system, and a suggested path for moving
from the current state to the desired future state. In the near term,
the Roadmap focuses on actions that will enable a majority of
individuals and providers across the care continuum to send, receive,
find and use a common set of electronic clinical information at the
nationwide level by the end of 2017. Moreover, the vision described in
the Roadmap significantly expands the types of electronic health
information, information sources, and information users well beyond
clinical information derived from electronic health records.
In addition, ONC has released the 2017 Interoperability Standards
Advisory (available at https://www.healthit.gov/standards-advisory), a
coordinated catalog of standards and implementation specifications to
enable priority health information exchange functions. Providers,
payers, and vendors are encouraged to take these health IT standards
into account as they implement interoperable health information
exchange across the continuum of care.
We encourage stakeholders to utilize health information exchange
and certified health IT to effectively and efficiently help providers
improve internal care delivery practices, support management of care
across the continuum, enable the reporting of electronically specified
clinical quality measures, and improve efficiencies and reduce
unnecessary costs. As adoption of certified health IT increases and
interoperability standards continue to mature, HHS will seek to
reinforce standards through relevant policies and programs.
VI. Collection of Information Requirements
A. Legislative Requirement for Solicitation of Comments
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection requirement
should be approved by OMB, section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires that we solicit comment on the following
issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
B. Requirements in Regulation Text
We are not proposing any changes to the regulatory text for the
ESRD PPS or for AKI dialysis payment in CY 2018.
C. Additional Information Collection Requirements
This proposed rule does not impose any new information collection
requirements in the regulation text, as specified above. However, there
are changes in some currently approved information collections. The
following is a discussion of these information collections.
1. ESRD QIP
a. Wage Estimates
To derive wage estimates, we used data from the U.S. Bureau of
Labor Statistics' May 2016 National Occupational Employment and Wage
Estimates. In the CY 2016 ESRD PPS final rule (80 FR 69069), we stated
that it was reasonable to assume that Medical Records and Health
Information Technicians, who are responsible for organizing and
managing health information data,\11\ are the individuals tasked with
submitting measure data to CROWNWeb and NHSN for purposes of the Data
Validation Studies rather than a Registered Nurse, whose duties are
centered on providing and coordinating care for patients.\12\ The mean
hourly wage of a Medical Records and Health Information Technician is
$19.93 per hour. Fringe benefit is calculated at 100 percent.
Therefore, using these assumptions, we estimate an hourly labor cost of
$39.86 as the basis of the wage estimates for all collection of
information calculations in the ESRD QIP. We have adjusted these
employee hourly wage estimates by a factor of 100 percent to reflect
current HHS department-wide guidance on estimating the cost of fringe
benefits and overhead. These are necessarily rough adjustments, both
because fringe benefits and overhead costs vary significantly from
employer to employer and because methods of estimating these costs vary
widely from study to study. Nonetheless, there is no practical
alternative and we believe that these are reasonable estimation
methods.
---------------------------------------------------------------------------
\11\ https://www.bls.gov/oes/current/oes292071.htm.
\12\ https://www.bls.gov/oes/current/oes291141.htm.
---------------------------------------------------------------------------
b. Time Required To Submit Data Based on Proposed Reporting
Requirements
In the CY 2016 ESRD PPS final rule (80 FR 69070), we estimated that
the time required to submit measure data using CROWNWeb is 2.5 minutes
per data element submitted, which takes into account the small
percentage of data that is manually reported, as well as the human
interventions required to modify batch submission files such that they
meet CROWNWeb's internal data validation requirements.
c. Data Validation Requirements for the PY 2020 ESRD QIP
Section IV.D.7 of this proposed rule outlines our data validation
proposals for PY 2020. Specifically, for the CROWNWeb validation, we
propose to continue randomly sampling records from 300 facilities as
part of our continuing pilot data-validation program. Each sampled
facility would be required to produce approximately 10 records, and the
sampled facilities will be reimbursed by our validation contractor for
the costs associated with copying and mailing the requested records.
The burden associated with these validation requirements is the time
and effort necessary to submit the requested records to a CMS
contractor. We estimate that it will take each facility approximately
2.5 hours to comply with this requirement. If 300 facilities are asked
to submit records, we estimate that the total combined annual burden
for these facilities will be 750 hours (300 facilities x 2.5 hours).
Since we anticipate that Medical Records and Health Information
Technicians or
[[Page 31224]]
similar administrative staff would submit this data, we estimate that
the aggregate cost of the CROWNWeb data validation would be
approximately $29,895 (750 hours x $39.86/hour), or a total of
approximately $93 ($29,895/300 facilities) per facility in the sample.
The burden associated with these requirements is captured in an
information collection request (OMB control number 0938-1289).
Under the proposed continued data validation study for validating
data reported to the NHSN Dialysis Event Module, we are proposing to
continue using the methodology finalized in the CY 2017 ESRD PPS final
rule, however we have proposed a modification to our sampling
methodology (81 FR 77956). A CMS contractor would send these facilities
requests for medical records for all patients with ``candidate events''
during the evaluation period. Overall, we estimate that, on average,
quarterly lists would include two positive blood cultures per facility,
but we recognize these estimates may vary considerably from facility to
facility. We estimate that it would take each facility approximately 60
minutes to comply with this requirement (30 minutes from each of the
two quarters in the evaluation period). If 35 facilities are asked to
submit records, we estimate that the total combined annual burden for
these facilities would be 35 hours (35 facilities x 1 hour). Since we
anticipate that Medical Records and Health Information Technicians or
similar administrative staff would submit this data, we estimate that
the aggregate cost of the NHSN data validation would be $1,395.10 (35
hours x $39.86/hour), or a total of $39.86 ($1,395.10/35 facilities)
per facility in the sample. The burden associated with these
requirements is captured in an information collection request (OMB
control number 0938-NEW).
To determine the burden associated with new collection of
information requirements, we look at each of these elements together:
The total number of patients nationally, the number of elements per
patient-year required for each measure, the amount of time required for
data entry, and the estimated wage plus benefits of the individuals
within facilities who are most likely to be entering data into
CROWNWeb. Therefore, based on this methodology, in the CY 2017 ESRD PPS
final rule, we anticipated the burden associated with the new
collection of information requirements was approximately $91 million
for the PY 2020 ESRD QIP (81 FR 77957).\13\ We are not changing our
data collection methodology for PY 2021; however, we are proposing to
replace two existing measures for PY 2021. We believe replacing the two
existing measures would have a de minimis effect on the overall burden
associated with collection of information requirements in PY 2021.
Accordingly, the PY 2021 burden estimate remains the same at $91
million. The net incremental burden from PY 2020 to PY 2021 is $0.
---------------------------------------------------------------------------
\13\ We note that the aggregate impact of the PY 2020 ESRD QIP
was included in the CY 2017 ESRD PPS final rule (81 FR 77834 through
77969). The previously finalized aggregate impact of $113 million
reflects the PY 2020 estimated payment reductions and the collection
of information requirements for the Ultrafiltration Rate Reporting
Measure, finalized in the CY 2017 ESRD PPS final rule (81 FR 77915).
---------------------------------------------------------------------------
VII. Request for Information on Medicare Flexibilities and Efficiencies
CMS is committed to transforming the health care delivery system--
and the Medicare program--by putting an additional focus on patient-
centered care and working with providers, physicians, and patients to
improve outcomes. We seek to reduce burdens for hospitals, physicians,
and patients, improve the quality of care, decrease costs, and ensure
that patients and their providers and physicians are making the best
health care choices possible. These are the reasons we are including
this Request for Information in this proposed rule.
As we work to maintain flexibility and efficiency throughout the
Medicare program, we would like to start a national conversation about
improvements that can be made to the health care delivery system that
reduce unnecessary burdens for clinicians, other providers, and
patients and their families. We aim to increase quality of care, lower
costs, improve program integrity, and make the health care system more
effective, simple and accessible.
We would like to take this opportunity to invite the public to
submit their ideas for regulatory, subregulatory, policy, practice, and
procedural changes to better accomplish these goals. Ideas could
include payment system redesign, elimination or streamlining of
reporting, monitoring and documentation requirements, aligning Medicare
requirements and processes with those from Medicaid and other payers,
operational flexibility, feedback mechanisms and data sharing that
would enhance patient care, support of the physician-patient
relationship in care delivery, and facilitation of individual
preferences. Responses to this Request for Information could also
include recommendations regarding when and how CMS issues regulations
and policies and how CMS can simplify rules and policies for
beneficiaries, clinicians, physicians, providers, and suppliers. Where
practicable, data and specific examples would be helpful. If the
proposals involve novel legal questions, analysis regarding CMS'
authority is welcome for CMS' consideration. We are particularly
interested in ideas for incentivizing organizations and the full range
of relevant professionals and paraprofessionals to provide screening,
assessment and evidence-based treatment for individuals with opioid use
disorder and other substance use disorders, including reimbursement
methodologies, care coordination, systems and services integration, use
of paraprofessionals including community paramedics and other
strategies. We are requesting commenters to provide clear and concise
proposals that include data and specific examples that could be
implemented within the law.
We note that this is a Request for Information only. Respondents
are encouraged to provide complete but concise responses. This Request
for Information is issued solely for information and planning purposes;
it does not constitute a Request for Proposal (RFP), applications,
proposal abstracts, or quotations. This Request for Information does
not commit the United States Government to contract for any supplies or
services or make a grant award.
Further, CMS is not seeking proposals through this Request for
Information and will not accept unsolicited proposals. Responders are
advised that the United States Government will not pay for any
information or administrative costs incurred in response to this
Request for Information; all costs associated with responding to this
Request for Information will be solely at the interested party's
expense. We note that not responding to this Request for Information
does not preclude participation in any future procurement, if
conducted. It is the responsibility of the potential responders to
monitor this Request for Information announcement for additional
information pertaining to this request. In addition, we note that CMS
will not respond to questions about the policy issues raised in this
Request for Information. CMS will not respond to comment submissions in
response to this Request for Information in the CY 2018 ESRD PPS final
rule. Rather, CMS
[[Page 31225]]
will actively consider all input as we develop future regulatory
proposals or future subregulatory policy guidance. CMS may or may not
choose to contact individual responders. Such communications would be
for the sole purpose of clarifying statements in the responders'
written responses. Contractor support personnel may be used to review
responses to this Request for Information. Responses to this notice are
not offers and cannot be accepted by the Government to form a binding
contract or issue a grant. Information obtained as a result of this
Request for Information may be used by the Government for program
planning on a nonattribution basis. Respondents should not include any
information that might be considered proprietary or confidential. This
Request for Information should not be construed as a commitment or
authorization to incur cost for which reimbursement would be required
or sought. All submissions become United States Government property and
will not be returned. CMS may publicly post the public comments
received, or a summary of those public comments.
VIII. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
IX. Economic Analyses
A. Regulatory Impact Analysis
1. Introduction
We have examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22,
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4,
1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive
Order 13771 on Reducing Regulation and Controlling Regulatory Costs
(January 30, 2017).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Section
3(f) of Executive Order 12866 defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1) Having an
annual effect on the economy of $100 million or more in any 1 year, or
adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local or tribal governments or communities (also
referred to as economically significant); (2) creating a serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order.
A regulatory impact analysis (RIA) must be prepared for major rules
with economically significant effects ($100 million or more in any 1
year). This rule is economically significant within the meaning of
section 3(f)(1) of the Executive Order, since it meets the $100 million
threshold. Additionally, OMB has determined that the actions are
significant within the meaning of section 3(f)(4) of the Executive
Order. Therefore, OMB has reviewed these proposed regulations, and the
Departments have provided the following assessment of their impact. We
solicit comments on the regulatory impact analysis provided.
2. Statement of Need
This rule proposes a number of routine updates and one policy
change to the ESRD PPS in CY 2018. The proposed routine updates include
the CY 2018 wage index values, the wage index budget-neutrality
adjustment factor, and outlier payment threshold amounts. The proposed
policy change involves an update to the outlier pricing policy. Failure
to publish this proposed rule would result in ESRD facilities not
receiving appropriate payments in CY 2018 for renal dialysis services
furnished to ESRD patients.
This rule proposes routine updates to the payment for renal
dialysis services furnished by ESRD facilities to individuals with AKI.
Failure to publish this proposed rule would result in ESRD facilities
not receiving appropriate payments in CY 2018 for renal dialysis
services furnished to patients with AKI in accordance with section
1834(r) of the Act.
This rule proposes to implement requirements for the ESRD QIP,
including a proposal to adopt a measure set for the PY 2021 program, as
directed by section 1881(h) of the Act. Failure to propose requirements
for the PY 2021 ESRD QIP would prevent continuation of the ESRD QIP
beyond PY 2020. In addition, proposing requirements for the PY 2021
ESRD QIP provides facilities with more time to review and fully
understand new measures before their implementation in the ESRD QIP.
3. Overall Impact
We estimate that the proposed revisions to the ESRD PPS will result
in an increase of approximately $100 million in payments to ESRD
facilities in CY 2018, which includes the amount associated with
updates to the outlier thresholds, outlier policy, and updates to the
wage index. We are estimating approximately $2 million that would now
be paid to ESRD facilities for dialysis treatments provided to AKI
beneficiaries.
For PY 2021, we estimate that the proposed revisions to the ESRD
QIP will result in a savings of $29 million, which includes a zero
incremental burden due to collection of information requirements and
$29 million in estimated payment reductions across all facilities.
If regulations impose administrative costs on private entities,
such as the time needed to read and interpret this proposed rule, we
should estimate the cost associated with regulatory review. Due to the
uncertainty involved with accurately quantifying the number of entities
that will review the rule, we assume that the total number of unique
commenters on last year's proposed rule will be the number of reviewers
of this proposed rule. We acknowledge that this assumption may
understate or overstate the costs of reviewing this rule. It is
possible that not all commenters reviewed last year's rule in detail,
and it is also possible that some reviewers chose not to comment on the
proposed rule. For these reasons we thought that the number of past
commenters would be a fair estimate of the number of reviewers of this
rule. We welcome any comments on the approach in estimating the number
of entities which will review this proposed rule.
We also recognize that different types of entities are in many
cases affected by mutually exclusive sections of this proposed rule,
and therefore for the purposes of our estimate we assume that
[[Page 31226]]
each reviewer reads approximately 50 percent of the rule. We seek
comments on this assumption.
Using the wage information from the BLS (https://www.bls.gov/oes/2015/may/naics4_621100.htm) for medical and health service managers
(Code 11-9111), we estimate that the cost of reviewing this rule is
$105.00 per hour, including overhead and fringe benefits. Assuming an
average reading speed, we estimate that it would take approximately
1.25 hours for the staff to review half of this proposed rule. For each
ESRD facility that reviews the rule, the estimated cost is $131.25
(1.25 hours x $105.00). Therefore, we estimate that the total cost of
reviewing this regulation is $19,162.50 ($131.25 x 146 reviewers).
B. Detailed Economic Analysis
1. CY 2018 End-Stage Renal Disease Prospective Payment System
a. Effects on ESRD Facilities
To understand the impact of the changes affecting payments to
different categories of ESRD facilities, it is necessary to compare
estimated payments in CY 2017 to estimated payments in CY 2018. To
estimate the impact among various types of ESRD facilities, it is
imperative that the estimates of payments in CY 2017 and CY 2018
contain similar inputs. Therefore, we simulated payments only for those
ESRD facilities for which we are able to calculate both current
payments and new payments.
For this proposed rule, we used CY 2016 data from the Part A and B
Common Working Files, as of February 17, 2017, as a basis for Medicare
dialysis treatments and payments under the ESRD PPS. We updated the
2016 claims to 2017 and 2018 using various updates. The updates to the
ESRD PPS base rate are described in section II.B.2.d of this proposed
rule. Table 10 shows the impact of the estimated CY 2018 ESRD payments
compared to estimated payments to ESRD facilities in CY 2017.
BILLING CODE 4120-01-P
[[Page 31227]]
[GRAPHIC] [TIFF OMITTED] TP05JY17.007
BILLING CODE 4120-01-C
Column A of the impact table indicates the number of ESRD
facilities for each impact category and column B indicates the number
of dialysis treatments (in millions). The overall effect of the
proposed changes to the outlier payment policy described in section
II.B.2.c of this proposed rule is shown in column C. For CY 2018, the
impact on all ESRD facilities as a result of the changes to the outlier
payment policy would be a 0.1 percent increase in estimated payments.
Nearly all ESRD facilities are anticipated to experience a positive
effect in their estimated CY 2018 payments as a result of the proposed
outlier policy changes.
Column D shows the effect of the proposed CY 2018 wage indices and
the wage index floor of 0.4000. The
[[Page 31228]]
categories of types of facilities in the impact table show changes in
estimated payments ranging from a 0.8 percent decrease to a 0.3 percent
increase due to these proposed updates in the wage indices.
Column E shows the effect of the proposed CY 2018 ESRD PPS payment
rate update. The proposed ESRD PPS payment rate update is 0.7 percent,
which reflects the proposed ESRDB market basket percentage increase
factor for CY 2018 of 2.2 percent, the 1.0 percent reduction as
required by the section 1881(b)(14)(F)(i)(I) of the Act, and the MFP
adjustment of 0.5 percent.
Column F reflects the overall impact, that is, the effects of the
proposed outlier policy changes, the proposed wage index floor, and
payment rate update. We expect that overall ESRD facilities would
experience a 0.8 percent increase in estimated payments in CY 2018. The
categories of types of facilities in the impact table show impacts
ranging from a decrease of 0.1 percent to an increase of 1.2 percent in
their CY 2018 estimated payments.
b. Effects on Other Providers
Under the ESRD PPS, Medicare pays ESRD facilities a single bundled
payment for renal dialysis services, which may have been separately
paid to other providers (for example, laboratories, durable medical
equipment suppliers, and pharmacies) by Medicare prior to the
implementation of the ESRD PPS. Therefore, in CY 2018, we estimate that
the proposed ESRD PPS would have zero impact on these other providers.
c. Effects on the Medicare Program
We estimate that Medicare spending (total Medicare program
payments) for ESRD facilities in CY 2018 would be approximately $10.0
billion. This estimate takes into account a projected increase in fee-
for-service Medicare dialysis beneficiary enrollment of 1.8 percent in
CY 2018.
d. Effects on Medicare Beneficiaries
Under the ESRD PPS, beneficiaries are responsible for paying 20
percent of the ESRD PPS payment amount. As a result of the projected
0.8 percent overall increase in the proposed CY 2018 ESRD PPS payment
amounts, we estimate that there will be an increase in beneficiary co-
insurance payments of 0.8 percent in CY 2018, which translates to
approximately $20 million. The $20 million is based on 20 percent of CY
2018 estimated total payment increase of $100 million.
e. Alternatives Considered
In section II.B.2.b of this proposed rule, we propose maintaining
the wage index floor at 0.4000. We considered increasing the wage index
floor to 0.5000 as well as increasing the wage index floor to 0.6000
and determined that maintaining the wage index floor at 0.4000 provided
the appropriate adjustment related to the cost of furnishing dialysis
in areas with a wage index less than 0.4000.
2. Proposed Payment for Renal Dialysis Services Furnished to
Individuals With AKI
a. Effects on ESRD Facilities
We analyzed CY 2016 hospital outpatient claims to identify the
number of treatments furnished historically for AKI patients. We
identified 8,900 outpatient treatments with AKI that also had dialysis
treatments that were furnished in CY 2016. We then inflated the 8,900
treatments to 2018 values using estimated population growth for fee-for
service non-ESRD beneficiaries. This results in an estimated 9,170
treatments that would now be paid to ESRD facilities for furnishing
dialysis to beneficiaries with AKI. Using the proposed CY 2018 ESRD
base rate of $233.31 and an average wage index multiplier, we are
estimating approximately $2 million that would now be paid to ESRD
facilities for dialysis treatments provided to AKI beneficiaries.
Ordinarily, we would provide a table showing the impact of this
provision on various categories of ESRD facilities. Because we have no
way to project how many patients with AKI requiring dialysis will
choose to have dialysis treatments at an ESRD facility, we are unable
to provide a table at this time.
b. Effects on Other Providers
Under section 1834(r) of the Act, as added by section 808(b) of
TPEA, we are proposing to update the payment rate for renal dialysis
services furnished by ESRD facilities to beneficiaries with AKI. The
only two Medicare providers authorized to provide these outpatient
renal dialysis services are hospital outpatient departments and ESRD
facilities. The decision about where the renal dialysis services are
furnished is made by the patient and his or her physician. Therefore,
this proposal will have zero impact on other Medicare providers.
c. Effects on the Medicare Program
We estimate approximately $2 million would be paid to ESRD
facilities in CY 2018 as a result of AKI patients receiving renal
dialysis services in the ESRD facility at the lower ESRD PPS base rate
versus receiving those services only in the hospital outpatient
setting.
d. Effects on Medicare Beneficiaries
Currently, beneficiaries have a 20 percent co-insurance obligation
when they receive AKI dialysis in the hospital outpatient setting. When
these services are furnished in an ESRD facility, the patients would
continue to be responsible for a 20 percent co-insurance. Because the
AKI dialysis payment rate paid to ESRD facilities is lower than the
outpatient prospective payment system's payment amount, we would expect
beneficiaries to pay less co-insurance when AKI dialysis is furnished
by ESRD facilities.
e. Alternatives Considered
As we discussed in the CY 2017 ESRD PPS proposed rule (81 FR
42870), we considered adjusting the AKI payment rate by including the
ESRD PPS case-mix adjustments, and other adjustments at section
1881(b)(14)(D) of the Act, as well as not paying separately for AKI
specific drugs and laboratory tests. We ultimately determined that
treatment for AKI is substantially different from treatment for ESRD
and the case-mix adjustments applied to ESRD patients may not be
applicable to AKI patients and as such, including those policies and
adjustment would be inappropriate. We will monitor utilization and
trends of items and services furnished to individuals with AKI for
purposes of refining the payment rate in the future. This monitoring
will assist us in developing knowledgeable, data-driven proposals.
3. ESRD QIP
a. Effects of the PY 2021 ESRD QIP on ESRD Facilities
The ESRD QIP provisions are intended to prevent possible reductions
in the quality of ESRD dialysis facility services provided to
beneficiaries as a result of payment changes under the ESRD PPS. The
methodology that we are proposing to use to determine a facility's TPS
for the PY 2021 ESRD QIP is described in section IV.E.8 of this
proposed rule. Any reductions in ESRD PPS payments as a result of a
facility's performance under the PY 2021 ESRD QIP would apply to ESRD
PPS payments made to the facility in CY 2021.
For the PY 2021 ESRD QIP, we estimate that, of the 6,453 dialysis
facilities (including those not receiving a TPS) enrolled in Medicare,
approximately 40 percent or 2,551 of the facilities would receive a
payment
[[Page 31229]]
reduction in PY 2021. The total payment reduction for all of the 2,551
facilities expected to receive a reduction is approximately $29 million
($29,017,218). Facilities that do not receive a TPS are not eligible
for a payment reduction.
Table 11 shows the overall estimated distribution of payment
reductions resulting from the PY 2021 ESRD QIP.
Table 11--Estimated Distribution of PY 2021 ESRD QIP Payment Reductions
------------------------------------------------------------------------
Number of Percent of
Payment reduction (%) facilities facilities
------------------------------------------------------------------------
0.0..................................... 3,469 57.6
0.5..................................... 1,507 25.0
1.0..................................... 754 12.5
1.5..................................... 228 3.8
2.0..................................... 62 1.0
------------------------------------------------------------------------
Note: This table excludes 433 facilities that we estimate will not
receive a payment reduction because they will not report enough data
to receive a TPS.
To estimate whether or not a facility would receive a payment
reduction in PY 2021, we scored each facility on achievement and
improvement on several measures we have previously finalized and for
which there were available data from CROWNWeb and Medicare claims.
Measures used for the simulation are shown in Table 12.
Table 12--Data Used To Estimate PY 2021 ESRD QIP Payment Reductions
----------------------------------------------------------------------------------------------------------------
Period of time used to
calculate achievement
Measure thresholds, performance Performance period
standards, benchmarks, and
improvement thresholds
----------------------------------------------------------------------------------------------------------------
VAT:
Standardized Fistula Ratio.......... Jan 2014-Dec 2014.............. Jan 2015-Dec 2015.
% Catheter.......................... Jan 2014-Dec 2014.............. Jan 2015-Dec 2015.
Kt/V Dialysis Adequacy Comprehensive.... Jan 2014-Dec 2014.............. Jan 2015-Dec 2015.
Hypercalcemia........................... Jan 2014-Dec 2014.............. Jan 2015-Dec 2015.
STrR.................................... Jan 2014-Dec 2014.............. Jan 2014-Dec 2014.
ICH CAHPS Survey........................ Jan 2015-Dec 2015.............. Jan 2015-Dec 2015.
SRR..................................... Jan 2014-Dec 2014.............. Jan 2015-Dec 2015.
NHSN BSI................................ Jan 2014-Dec 2014.............. Jan 2015-Dec 2015.
SHR..................................... Jan 2014-Dec 2014.............. Jan 2015-Dec 2015.
----------------------------------------------------------------------------------------------------------------
For all measures except STrR and SHR, clinical measure topic areas
with less than 11 cases for a facility were not included in that
facility's TPS. For SHR and STrR, facilities were required to have at
least 5 and 10 patient-years at risk, respectively, in order to be
included in the facility's TPS. Each facility's TPS was compared to an
estimated minimum TPS and an estimated payment reduction table that
were consistent with the proposals outlined in section IV.E.8 of this
proposed rule. Facility reporting measure scores were estimated using
available data from CY 2014 and 2015. Facilities were required to have
a score on at least one clinical and one reporting measure to receive a
TPS.
To estimate the total payment reductions in PY 2021 for each
facility resulting from this proposed rule, we multiplied the total
Medicare payments to the facility during the 1-year period between
January 2015 and December 2015 by the facility's estimated payment
reduction percentage expected under the ESRD QIP, yielding a total
payment reduction amount for each facility: Total ESRD payment in
January 2015 through December 2015 times the estimated payment
reduction percentage.
Table 13 shows the estimated impact of the finalized ESRD QIP
payment reductions to all ESRD facilities for PY 2021. The table
details the distribution of ESRD facilities by facility size (both
among facilities considered to be small entities and by number of
treatments per facility), geography (both urban/rural and by region),
and by facility type (hospital based/freestanding facilities). Given
that the time periods used for these calculations will differ from
those we propose to use for the PY 2021 ESRD QIP, the actual impact of
the PY 2021 ESRD QIP may vary significantly from the values provided
here.
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b. Effects on Other Providers
The ESRD QIP is applicable to outpatient dialysis facilities.
Therefore, this proposal will have zero impact on other Medicare
providers. We are aware that several of our measures do impact other
providers. For example, with the introduction of the Standardized
Readmission Ratio Clinical measure in PY 2017 and the Standardized
Hospitalization Ratio Clinical Measure in PY 2020, we anticipate that
hospitals may experience financial savings as dialysis facilities work
to reduce the number of unplanned readmissions and hospitalizations. We
are actively exploring various methods to assess the impact these
measures have on hospitals and other outpatient facilities.
c. Effects on the Medicare Program
For PY 2021, we estimate that ESRD QIP will contribute
approximately $29 million ($29,017,218) in Medicare savings. For
comparison, Table 14 shows the payment reductions achieved by the ESRD
QIP program for PYs 2016 through 2021.
Table 14--Payment Reductions Payment Year 2016 Through 2021
------------------------------------------------------------------------
Estimated payment reductions
Payment year (citation)
------------------------------------------------------------------------
PY 2021........................... $29,017,218.
PY 2020........................... $31,581,441 (81 FR 77960).
PY 2019........................... $15,470,309 (80 FR 69074).
PY 2018........................... $11,576,214 (79 FR 66257).
PY 2017........................... $11,954,631 (79 FR 66255).
PY 2016........................... $15,137,161 (78 FR 72247).
------------------------------------------------------------------------
d. Effects on Medicare Beneficiaries
The ESRD QIP is applicable to outpatient dialysis facilities. Since
the program's inception, there is evidence of improved performance on
ESRD QIP measures. As we stated in the CY 2017 ESRD PPS final rule, one
objective measure we can examine to demonstrate the improved quality of
care over time is the improvement of performance standards (81 FR
77873). As the ESRD QIP has refined its measure set and as facilities
have gained experience with the measures included in the program,
performance standards have generally continued to rise. We view this as
evidence that facility performance (and therefore the quality of care
provided to Medicare beneficiaries) is objectively improving. To date
we have been unable to examine the impact of the ESRD QIP on Medicare
beneficiaries including the financial impact of the program or the
impact on the health outcomes of beneficiaries. However, in future
years we are interested in examining these impacts through the addition
of new measures to the program and through the analysis of available
data from our existing measures.
e. Alternatives Considered
In an effort to reduce administrative and financial burden on
dialysis facilities, we considered the burden associated with each of
the measures included in the ESRD QIP to determine whether any of the
measures could feasibly be removed from the program at this time. The
Ultrafiltration Rate Reporting measure, finalized for inclusion in the
program beginning with PY 2020, adds a significant burden to facilities
because of the number of data elements required to be entered for each
patient treated by the facility. We carefully considered whether this
measure could be removed from the program in an effort to reduce burden
for facilities, but as we noted in the CY 2017 ESRD PPS final rule,
this measure is extremely valuable from a clinical perspective. Studies
suggest that higher ultrafiltration rates are associated with higher
mortality and higher odds of an ``unstable'' dialysis session, and that
rapid rates of fluid removal at dialysis can precipitate events such as
intradialytic hypotension, subclinical, yet significantly decreased
organ perfusion, and in some cases myocardial damage and heart failure
(81 FR 77912). Therefore we continue to believe that, despite the high
burden associated with this measure, it is clinically valuable and
important to continue including this measure in the ESRD QIP's measure
set and that the clinical benefits outweigh the burden associated with
the measure.
C. Accounting Statement
As required by OMB Circular A-4 (available at https://www.whitehouse.gov/omb/circulars_a004_a-4), in Table 15 below, we have
prepared an accounting statement showing the classification of the
transfers and costs associated with the various provisions of this
proposed rule.
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Table 15--Accounting Statement: Classification of Estimated Transfers
and Costs/Savings
------------------------------------------------------------------------
Category Transfers
------------------------------------------------------------------------
ESRD PPS and AKI
------------------------------------------------------------------------
Annualized Monetized Transfers......... $80 million.
From Whom to Whom...................... Federal government to ESRD
providers.
Increased Beneficiary Co-insurance $20 million.
Payments.
From Whom to Whom...................... Beneficiaries to ESRD
providers.
------------------------------------------------------------------------
ESRD QIP for PY 2021
------------------------------------------------------------------------
Annualized Monetized Transfers......... $-29 million.
From Whom to Whom...................... Federal government to ESRD
providers (payment
reductions).
------------------------------------------------------------------------
Category Costs
------------------------------------------------------------------------
Annualized Monetized ESRD Provider $0.
Costs.
------------------------------------------------------------------------
In accordance with the provisions of Executive Order 12866, this
proposed rule was reviewed by the Office of Management and Budget.
X. Regulatory Flexibility Act Analysis
The Regulatory Flexibility Act (September 19, 1980, Pub. L. 96-354)
(RFA) requires agencies to analyze options for regulatory relief of
small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, small entities
include small businesses, nonprofit organizations, and small
governmental jurisdictions. Approximately 13 percent of ESRD dialysis
facilities are considered small entities according to the Small
Business Administration's (SBA) size standards, which classifies small
businesses as those dialysis facilities having total revenues of less
than $38.5 million in any 1 year. Individuals and States are not
included in the definitions of a small entity. For more information on
SBA's size standards, see the Small Business Administration's Web site
at https://www.sba.gov/content/small-business-size-standards (Kidney
Dialysis Centers are listed as 621492 with a size standard of $38.5
million).
We do not believe ESRD facilities are operated by small government
entities such as counties or towns with populations of 50,000 or less,
and therefore, they are not enumerated or included in this estimated
RFA analysis. Individuals and States are not included in the definition
of a small entity.
For purposes of the RFA, we estimate that approximately 13 percent
of ESRD facilities are small entities as that term is used in the RFA
(which includes small businesses, nonprofit organizations, and small
governmental jurisdictions). This amount is based on the number of ESRD
facilities shown in the ownership category in Table 10. Using the
definitions in this ownership category, we consider the 502 facilities
that are independent and the 368 facilities that are shown as hospital-
based to be small entities. The ESRD facilities that are owned and
operated by Large Dialysis Organizations (LDOs) and regional chains
would have total revenues of more than $38.5 million in any year when
the total revenues for all locations are combined for each business
(individual LDO or regional chain), and are not, therefore, included as
small entities.
For the ESRD PPS updates proposed in this rule, a hospital-based
ESRD facility (as defined by type of ownership, not by type of dialysis
facility) is estimated to receive a 1.1 percent increase in payments
for CY 2018. An independent facility (as defined by ownership type) is
also estimated to receive a 0.8 percent increase in payments for CY
2018.
For AKI dialysis, we are unable to estimate whether patients will
go to ESRD facilities, however, we have estimated there is a potential
for $2.0 million in payment for AKI dialysis treatments that could
potentially be furnished in ESRD facilities.
We estimate that of the 2,551 ESRD facilities expected to receive a
payment reduction in the PY 2021 ESRD QIP, 325 are ESRD small entity
facilities. We present these findings in Table 11 (``Estimated
Distribution of PY 2021 ESRD QIP Payment Reductions'') and Table 13
(``Impact of Proposed QIP Payment Reductions to ESRD Facilities for PY
2021'') above. We estimate that the payment reductions will average
approximately $11,375 per facility across the 2,551 facilities
receiving a payment reduction, and $13,885 for each small entity
facility. Using our estimates of facility performance, we also
estimated the impact of payment reductions on ESRD small entity
facilities by comparing the total estimated payment reductions for 922
small entity facilities with the aggregate ESRD payments to all small
entity facilities. We estimate that there are a total of 922 small
entity facilities, and that the aggregate ESRD PPS payments to these
facilities would decrease 0.45 percent in PY 2021.
Therefore, the Secretary has determined that this proposed rule
would not have a significant economic impact on a substantial number of
small entities. The economic impact assessment is based on estimated
Medicare payments (revenues) and HHS's practice in interpreting the RFA
is to consider effects economically ``significant'' only if greater
than 5 percent of providers reach a threshold of 3 to 5 percent or more
of total revenue or total costs. We solicit comment on the RFA analysis
provided.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. Any
such regulatory impact analysis must conform to the provisions of
section 603 of the RFA. For purposes of section 1102(b) of the Act, we
define a small rural hospital as a hospital that is located outside of
a metropolitan statistical area and has fewer than 100 beds. We do not
believe this proposed rule will have a significant impact on operations
of a substantial number of small rural hospitals because most dialysis
facilities are freestanding. While there are 132 rural hospital-based
dialysis facilities, we do not know how many of them are based at
hospitals with fewer than 100 beds. However, overall, the 132 rural
hospital-based dialysis facilities will experience an estimated 0.7
percent decrease in payments. As a result, this proposed rule is not
estimated to have a
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significant impact on small rural hospitals.
Therefore, the Secretary has determined that this proposed rule
would not have a significant impact on the operations of a substantial
number of small rural hospitals.
XI. Unfunded Mandates Reform Act Analysis
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2017, that
is approximately $148 million. This proposed rule does not include any
mandates that would impose spending costs on State, local, or Tribal
governments in the aggregate, or by the private sector, of $141
million. Moreover, HHS interprets UMRA as applying only to unfunded
mandates. We do not interpret Medicare payment rules as being unfunded
mandates, but simply as conditions for the receipt of payments from the
federal government for providing services that meet federal standards.
This interpretation applies whether the facilities or providers are
private, State, local, or Tribal.
XII. Federalism Analysis
Executive Order 13132 on Federalism (August 4, 1999) establishes
certain requirements that an agency must meet when it promulgates a
proposed rule (and subsequent final rule) that imposes substantial
direct requirement costs on State and local governments, preempts State
law, or otherwise has Federalism implications. We have reviewed this
proposed rule under the threshold criteria of Executive Order 13132,
Federalism, and have determined that it will not have substantial
direct effects on the rights, roles, and responsibilities of States,
local or Tribal governments.
XIII. Reducing Regulation and Controlling Regulatory Costs
Executive Order 13771, entitled Reducing Regulation and Controlling
Regulatory Costs (82 FR 9339), was issued on January 30, 2017. This
proposed rule is not expected to be subject to the requirements of E.O.
13771 because, if finalized as proposed, it is expected to result in no
more than de minimis costs.
XIV. Congressional Review Act
This proposed rule is subject to the Congressional Review Act
provisions of the Small Business Regulatory Enforcement Fairness Act of
1996 (5 U.S.C. 801 et seq.) and has been transmitted to the Congress
and the Comptroller General for review.
XV. Files Available to the Public via the Internet
The Addenda for the annual ESRD PPS proposed and final rulemakings
will no longer appear in the Federal Register. Instead, the Addenda
will be available only through the Internet and is posted on the CMS
Web site at https://www.cms.gov/ESRDPayment/PAY/list.asp In addition to
the Addenda, limited data set (LDS) files are available for purchase at
https://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/LimitedDataSets/EndStageRenalDiseaseSystemFile.html. Readers who
experience any problems accessing the Addenda or LDS files, should
contact ESRDPayment@cms.hhs.gov.
Dated: June 27, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
Approved: June 27, 2017.
Thomas E. Price,
Secretary, Department of Health and Human Services.
[FR Doc. 2017-13908 Filed 6-29-17; 4:15 pm]
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