Medicare Program; End-Stage Renal Disease Quality Incentive Program, 49215-49232 [2010-18465]
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Federal Register / Vol. 75, No. 155 / Thursday, August 12, 2010 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 413
[CMS–3206–P]
RIN 0938–AP91
Medicare Program; End-Stage Renal
Disease Quality Incentive Program
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
This proposed rule proposes
to implement a quality incentive
program (QIP) for Medicare outpatient
end-stage renal disease (ESRD) dialysis
providers and facilities with payment
consequences beginning January 1,
2012, in accordance with section
1881(h) of the Act (added on July 15,
2008 by section 153(c) of the Medicare
Improvements for Patients and
Providers Act (MIPPA)). The proposed
ESRD QIP would reduce ESRD
payments by up to 2.0 percent for
dialysis providers and facilities that fail
to meet or exceed a total performance
score for performance standards
established with respect to certain
specified measures.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. eastern standard time (EST)
on September 24, 2010.
ADDRESSES: In commenting, please refer
to file code CMS–3206–P. Because of
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CMS–3206–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.
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may send written comments to the
following address only: Centers for
Medicare & Medicaid Services,
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SUMMARY:
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following addresses:
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b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
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Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
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please call telephone number (410) 786–
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document does not propose any
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‘‘Collection of Information
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For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Lynn Riley, (410) 786–1286.
SUPPLEMENTARY INFORMATION: Inspection
of Public Comments: All comments
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comment period are available for
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Comments received timely will also
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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.
Table of Contents
I. Background
A. Evolution of Quality Monitoring
Initiatives
B. Statutory Authority for ESRD QIP
C. Selection of the ESRD QIP Measures
II. Provisions of the Proposed Rule
A. Overview of the Proposed ESRD QIP
B. Performance Standards for the ESRD
QIP Measures
C. Performance Period for the ESRD QIP
Measures
D. Methodology for Calculating the Total
Performance Score for the ESRD QIP
Measures
E. Payment Reductions Using the Total
Performance Score
F. Public Reporting Requirements
1. Introduction
2. Notifying Providers/Facilities of Their
QIP Scores
3. Informing the Public Through FacilityPosted Certificates
4. Informing the Public Through
Medicare’s Web Site
III. Future QIP Considerations
A. Program Monitoring and Evaluation
B. QIP Changes and Updates
IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impact Analysis
A. Overall Impact
B. Anticipated Effects
C. Alternatives Considered
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:
CIP Core Indicators Project
CMS Centers for Medicare & Medicaid
Services
CPM Clinical performance measure
CROWNWeb Consolidated Renal
Operations in a Web-Enabled Network
DFC Dialysis Facility Compare
DFR Dialysis Facility Report
ESA Erythropoiesis stimulating agent
ESRD End stage renal disease
FDA Food and Drug Administration
Kt/V A measure of dialysis adequacy where
K is dialyzer clearance, t is dialysis time,
and V is total body water volume
LDO Large dialysis organization
MIPPA Medicare Improvements for Patients
and Providers Act of 2008 (Pub. L. 110–
275)
NQF National Quality Forum
PPS Prospective payment system
QIP Quality incentive program
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REMIS Renal management information
system
RFA Regulatory Flexibility Act
SIMS Standard information management
system
SSA Social Security Administration
the Act Social Security Act
URR Urea reduction ratio
2. Clinical Performance Measures (CPM)
Project
I. Background
A. Evolution of Quality Monitoring
Initiative
Monitoring the quality of care
provided to ESRD patients and
provider/facility accountability are
important components of the Medicare
ESRD payment system and have been
priorities for over 30 years. We will
describe the evolution of our ESRD
quality monitoring initiatives by
category below.
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1. ESRD Network Organization Program
In the End-Stage Renal Disease
Amendments of 1978 (Pub. L. 95–292),
Congress required the formation of
ESRD Network Organizations to further
support the ESRD program. CMS
currently contracts with 18 ESRD
Networks throughout the United States
to perform oversight activities and to
assist dialysis providers and facilities in
providing appropriate care for their
dialysis patients. The Networks’
responsibilities include monitoring the
quality of care provided to ESRD
patients, providing technical assistance
to patients who have ESRD and to
providers/facilities that treat ESRD
patients to assist them in improving
care, addressing patient complaints and/
or grievances, and emergency
preparedness. In 1994, CMS and the
ESRD Networks, with input from the
renal community, established the ESRD
Core Indicators Project (CIP). The ESRD
CIP was CMS’s first nationwide
population-based study designed to
assess and identify opportunities to
improve the care of patients with ESRD.
This project established the first
consistent clinical ESRD database.
Information in this database included
clinical measures thought to be
indicative of key components of care
provided to individuals who required
dialysis. The initial Core Indicators
focused on adult hemodialysis patients
who received care in dialysis facilities.
The Core Indicators included measures
related to anemia management,
adequacy of hemodialysis, nutritional
status and blood pressure control. On
March 1, 1999, the ESRD CIP was
merged with the ESRD Clinical
Performance Measures (CPM) Project
(described below).
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Section 4558(b) of the Balanced
Budget Act of 1997 required CMS to
develop and implement, by January 1,
2000, a method to measure and report
the quality of renal dialysis services
furnished under the Medicare program.
To implement this legislation, CMS
developed the ESRD Clinical
Performance Measures (CPM) Project
based on the National Kidney
Foundation’s Dialysis Outcome Quality
Initiative (NKF–DOQI) Clinical Practice
Guidelines. The purpose of collecting
and reporting the ESRD CPMs was to
enable us to provide comparative data to
ESRD providers/facilities to assist them
in assessing and improving the care
furnished to ESRD patients.
3. Dialysis Facility Compare (DFC)
Also in response to the Balanced
Budget Act of 1997, CMS created
Dialysis Facility Compare (DFC) as a
new feature on https://
www.medicare.gov that was modeled
after Nursing Home Compare and
continues to be used by CMS today.
CMS worked with a contractor and a
consumer workgroup to identify dialysis
facility-specific measures that could be
provided to the public for consumer
choice and information purposes. This
tool was launched in January 2001 on
the https://www.medicare.gov/Dialysis
Web site to provide information to the
public for comparing the quality of
dialysis facilities across the country,
including specific information about
services available and the quality of care
furnished by a specific dialysis facility/
provider. DFC captures administrative
and quality related data submitted by
dialysis facilities and providers.
The quality measures initially
reported on DFC were measures of
anemia control, adequacy of
hemodialysis treatment and patient
survival. Medicare claims data were
used to calculate the anemia
management and hemodialysis
adequacy rates, and administrative data
(non-clinically based data such as
demographic data, and data acquired
from the Social Security Administration
(SSA) and obtained from the CMS forms
2728 and 2746) were used to determine
patient survival rates. The anemia
measure assessed the percentage of
Medicare patients receiving an
erythropoiesis-stimulating agent (ESA)
at a given provider/facility whose
anemia (low red blood cell count) was
not controlled. More specifically, the
anemia measure when DFC was
launched in January 2001 assessed the
percentage of Medicare patients whose
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hematocrit levels were at 33 percent (33
percent out of 100 percent) or more (or
hemoglobin levels of 11 g/dL or more).
Since that time, evidence about
increased risk of certain adverse events
associated with the use of ESAs, which
are used to treat anemia, raised concerns
about patients who have hemoglobin
levels that are too high, as well as
patients whose hemoglobin levels are
too low. The Food and Drug
Administration (FDA) responded by
requiring manufacturers to develop a
Medication Guide (https://www.fda.gov/
Drugs/DrugSafety/PublicHealth
Advisories/ucm054716.htm) and to
ensure that this information is provided
to patients. The labeling guideline for
ESAs states ‘‘The dosing
recommendations for anemic patients
with chronic renal failure have been
revised to recommend maintaining
hemoglobin levels within 10 g/dL to 12
g/dL’’. As a result of this guideline, in
November 2008 DFC was revised to
include two anemia measures: one
measure shows the percentage of
patients whose hemoglobin levels are
considered too low (that is, below 10 g/
dL), and a second measure shows the
percentage of patients whose
hemoglobin levels are too high (that is,
above 12 g/dL). The dialysis adequacy
measure assesses the percentage of incenter hemodialysis Medicare patients
treated by the facility who had enough
wastes removed from their blood during
dialysis. More specifically, the measure
is the percentage of Medicare patients
with urea reduction ratio (URR) levels of
65 percent or more. The patient survival
measure indicates general facility
survival as better than expected, as
expected, or worse than expected. These
measures are updated annually on the
DFC Web site, usually at the end of the
year, using Medicare claims data from
the previous year for the hemodialysis
adequacy and anemia measures and
Medicare administrative data from the
past 4 years for the patient survival
measure.
4. ESRD Quality Initiative
In 2004, the ESRD Quality Initiative
was launched and continues today. The
objective is to stimulate and support
significant improvements in the quality
of dialysis care. The initiative aims to
refine and standardize dialysis care
measures, ESRD data definitions, and
data transmission to support the needs
of the ESRD program; empower patients
and consumers by providing access to
facility service and quality information;
provide quality improvement support to
dialysis facilities and providers; assure
compliance with conditions of coverage;
and build strategic partnerships with
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patients, providers/facilities,
professionals, and other stakeholders.
Components of this Quality Initiative
include the DFC, and the CPM Project.
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5. ESRD Conditions for Coverage
On April 15, 2008, we published in
the Federal Register, the updated ESRD
Conditions for Coverage final rule,
which contains revised requirements
that dialysis providers and facilities
must meet in order to be approved by
Medicare and receive payment (73 FR
20370 April 15, 2008). As part of the
revised requirements, dialysis providers
and facilities are each required to
implement their own quality assessment
and performance improvement program.
In addition, providers and facilities are
required to submit electronically the
CPMs developed under the ESRD CPM
Project for all Medicare patients on an
annual basis. The CPMs were updated
and expanded in April 2008. The
current CPMs include 26 measures in
the areas of anemia management;
hemodialysis adequacy; peritoneal
dialysis adequacy; mineral metabolism;
vascular access; patient education/
perception of care/quality of life; and
patient survival.
6. CROWNWeb
CMS has developed a new web-based
system, Consolidated Renal Operations
in a Web-Enabled Network
(CROWNWeb) for the purposes of
electronically collecting information
about patients, facilities, providers, and
clinical data to support the CPM Project.
CROWNWeb supports the mineral
metabolism, anemia management,
hemodialysis adequacy, peritoneal
dialysis adequacy, survival, and type of
vascular access CPMs. Use of the
CROWNWeb system will increase the
efficiency of data collection for both
CMS and providers/facilities, improve
data quality, and provide a more stable
and accessible platform for continual
improvements in functionality. In
February 2009, for Phase one, we began
implementing the CROWNWeb system
with a number of providers/facilities
testing the system and expanded
reporting to additional providers/
facilities in July 2009 for Phase two.
During these initial phases, nearly 200
dialysis providers/facilities
(representing a cross section of small
independent facilities and large dialysis
organizations (LDOs)) were selected to
enter data into CROWNWeb. These
providers/facilities worked closely with
CMS, their respective ESRD Networks,
and CROWNWeb development and
support contractors to understand the
requirements of CROWNWeb, and to
refine the internal business processes
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and procedures used to submit data
effectively and efficiently into the
system.
The successful launch of both Phase
One and Phase Two and helpful
feedback provided by users has enabled
CMS to work on additional upgrades to
CROWNWeb that address both the
technical and usability elements of the
system. We continue to further refine
the system as an additional tool for
quality improvement.
7. QIP Conceptual Model
On September 29, 2009, we published
in the Federal Register (74 FR 49922),
the ESRD Prospective Payment System
(PPS) proposed rule, describing how the
Agency proposes to implement the new
ESRD PPS in 2011. As part of that
proposed rule, we outlined a conceptual
model of the initial ESRD QIP design
and solicited public comments. We
received and reviewed many helpful
comments regarding the design of the
QIP that contributed to the development
of this proposed rule.
B. Statutory Authority for the ESRD QIP
Congress required in section 153 of
MIPPA that the Secretary implement an
ESRD quality incentive program (QIP).
We believe that the QIP is the next step
in the evolution of the ESRD quality
program because it measures provider/
facility performance rather than simply
reporting outcomes data.
Specifically, section 1881(h) of the
Social Security Act (the Act), as added
by section 153(c) of MIPPA, requires the
Secretary to develop a QIP that will
result in payment reductions to
providers of services and dialysis
facilities that do not meet or exceed a
total performance score with respect to
performance standards established for
certain specified measures. As provided
under this section, the payment
reductions, which will be up to 2.0
percent of payments otherwise made to
providers and facilities under section
1881(b)(14) of the Act, will apply to
payment for renal dialysis services
furnished on or after January 1, 2012.
The total performance score that
providers and facilities must initially
meet or exceed in order to receive their
full payment in 2012 will be based on
a specific performance period prior to
this date. Under section 1881(h)(1)(C) of
the Act, the payment reduction will
only apply with respect to the year
involved for a provider/facility and will
not be taken into account when
computing future payment rates for the
impacted provider/facility.
For the ESRD quality incentive
program, section 1881(h) of the Act
generally requires the Secretary to: (1)
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Select measures; (2) establish the
performance standards that apply to the
individual measures; (3) specify a
performance period with respect to a
year; (4) develop a methodology for
assessing the total performance of each
provider and facility based on the
performance standards with respect to
the measures for a performance period;
and (5) apply an appropriate payment
reduction to providers and facilities that
do not meet or exceed the established
total performance score.
We view the ESRD QIP required by
section 1881(h) of the Act as the next
step in the evolution of the ESRD
quality program that began more than 30
years ago. Our vision is to implement a
robust, comprehensive ESRD QIP that
builds on the foundation that has
already been established.
C. Selection of the ESRD QIP Measures
As required by section
1881(h)(2)(A)(i) of the Act, we finalized
the measures for the initial year of the
QIP to include two-anemia management
measures that reflect the labeling
approved by the Food and Drug
Administration (FDA) for the
administration of erythropoesis
stimulating agents (ESAs), and onehemodialysis adequacy measure in the
Medicare End-Stage Renal Disease
Prospective Payment System Final Rule
(CMS–1418–F) published on August 12,
2010. The following are the three
finalized measures for the initial year of
the ESRD QIP:
• Percentage of Medicare patients
with an average Hemoglobin <10.0 g/dL
• Percentage of Medicare patients
with an average Hemoglobin >12.0 g/dL
• Percentage of Medicare patients
with an average Urea Reduction Ratio
(URR) >65 percent.
Data for these measures are collected
from ESRD claims submitted to CMS for
payment purposes. We have publicly
reported anemia and adequacy of
hemodialysis data on DFC since January
2001. The quality measure selection is
limited to these three measures for the
first year of the QIP because they are
measures for which we already have
complete data available to us. We are
working to develop additional quality
measures that we can adopt for the
ESRD QIP in subsequent years.
The ESRD QIP is the first Medicare
program that links any provider or
facility payments to performance based
on outcomes as assessed through
specific quality measures. The three
measures that we adopted for the initial
year of the ESRD QIP are important
indicators of patient outcomes because
poor management of anemia and
inadequate dialysis can lead to
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avoidable hospitalizations, decreased
quality of life, and death. These
measures are at the core of medical
management of ESRD patients.
As noted previously, data for these
three measures are collected through
ESRD claims submitted to CMS. The
process used to ensure accuracy of
claims coding and measure calculation
has been used and refined since our
implementation of the DFC. A full
description of the methodologies used
for the calculation of the measures can
be reviewed at: https://
www.dialysisreports.org/pdf/esrd/
public/DFRGuide.pdf under the
‘‘Facility Modality, Hemoglobin, and
Urea Reduction Ratio’’ section.
As we have previously stated, we are
committed to adding additional quality
measures as soon as complete data
sources become available to us. For
example, we are considering the
possibility of adopting measures such as
Kt/V, vascular access rates, bone and
mineral metabolism, and access
infection rates to the ESRD QIP for
future years. CMS is committed to
further development of quality measures
for future years of the QIP in order to
better assess the quality of care provided
by ESRD facilities.
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II. Provisions of the Proposed Rule
A. Overview of the Proposed ESRD QIP
This proposed rule proposes to
implement a quality incentive program
for Medicare ESRD dialysis providers
and facilities with payment reductions
beginning January 1, 2012, in
accordance with the statutory
provisions set forth in section 1881(h) of
the Act. This proposed rule was
developed based on the conceptual
model set forth in the September 29,
2009 proposed rule (74 FR 49922) and
on comments received on this model. In
general, we propose to calculate
individual total performance scores
ranging from 0–30 points for providers
and facilities based on the three
finalized measures. We propose to
weigh the total performance score for
each provider/facility such that the
percentage of Medicare patients with an
average Hemoglobin <10 g/dL measure
makes up 50 percent of the score, and
the other hemoglobin measure and the
hemodialysis adequacy measure will
each be 25 percent of the score.
Providers/facilities that do not meet or
exceed a certain total performance score
would receive a payment reduction
ranging from 0.5 percent to 2.0 percent.
We also propose below how we plan to
implement the public reporting
requirements in section 1881(h)(6) of
the Act.
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B. Performance Standards for the ESRD
QIP Measures
Section 1881(h)(4)(A) of the Act
requires the Secretary to establish
performance standards with respect to
the measures selected for the QIP for a
performance period with respect to a
year. Section 1881(h)(4)(B) of the Act
provides that the performance standards
shall include levels of achievement and
improvement, as determined
appropriate by the Secretary. However,
for the first performance period, we
propose to establish a performance
standard for the two anemia
management and one hemodialysis
adequacy measures based on the special
rule in section 1881(h)(4)(E) of the Act.
This provision requires the Secretary to
‘‘initially’’ use as a performance standard
for the anemia management and
hemodialysis adequacy measures the
lesser of a provider/facility-specific
performance rate in the year selected by
the Secretary under the second sentence
of section 1881(b)(14)(A)(ii) of the Act,
or a standard based on the national
performance rate for such measures in a
period determined by the Secretary. We
are not proposing to include in this
initial performance standard levels of
achievement or improvement because
we do not believe that section
1881(h)(4)(E) of the Act requires that we
include such levels. In addition, we
interpret the term ‘‘initially’’ to apply
only to the performance period
applicable for payment consequence
calendar year 2012. For subsequent
performance periods, we plan to
propose performance standards under
section 1881(h)(4)(A) of the Act. Such
standards will include levels of
achievement and improvement, as
required under section 1881(h)(4)(B) of
the Act, and are discussed below in
section III.B QIP Changes and Updates.
As stated above, to implement the
special rule for the anemia management
and hemodialysis adequacy measures,
we propose to select as the performance
standard the lesser of the performance
of a provider or facility on each measure
during 2007 (the year selected by the
Secretary under the second sentence of
section 1881(b)(14)(A)(ii) of the Act,
referred to as the base utilization year)
or the national performance rates of all
providers/facilities for each measure in
2008.
In terms of establishing a performance
standard based on national performance
rates, we propose to adopt a standard
that is equal to the national performance
rates of all dialysis providers and
facilities based on 2008 data, as
calculated and reported on the Dialysis
Facility Compare Web site. We propose
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to use 2008 data because it is the most
recent year for which data is publicly
available prior to the beginning of the
proposed performance period
(discussed below). Specifically, the rates
for the anemia management and
hemodialysis adequacy measures were
posted on DFC in November 2009, and
are as follows:
• For the anemia management
measure (referred to in this proposed
rule as ‘‘Hemoglobin Less Than 10 g/
dL’’)—the national performance
percentage of Medicare patients who
have an average hemoglobin value less
than 10.0 g/dL: The national
performance rate is 2 percent.
• For the anemia management
measure (referred to in this NPRM as
‘‘Hemoglobin More Than 12 g/dL’’)—the
national performance percentage of
Medicare patients who have an average
hemoglobin value greater than 12.0 g/
dL: The national performance rate is 26
percent.
• For the proposed hemodialysis
adequacy measure (referred to in this
NPRM as ‘‘Hemodialysis Adequacy
Measure’’)—the percentage of Medicare
patients who have an average URR level
above 65 percent: The national
performance rate is 96 percent.
This means that, for the purpose of
implementing the special rule for the
anemia management and hemodialysis
adequacy measures, we propose that the
performance standard for each of the
three measures for the initial
performance period with respect to 2012
payment would be the lesser of (1) the
provider/facility-specific rate for each of
these measures in 2007, or (2) the 2008
national average rates for each of these
measures.
C. Performance Period for the ESRD QIP
Measures
Section 1881(h)(4)(D) of the Act
requires the Secretary to establish a
performance period with respect to a
year, and for that performance period to
occur prior to the beginning of such
year. Because we are required under
section 1881(h)(1)(A) of the Act to
implement the payment reduction
beginning with renal dialysis services
furnished on or after January 1, 2012,
the first performance period would need
to occur prior to that date.
We propose to select all of CY 2010
as the initial performance period for the
three finalized measures. We believe
that this is the performance period that
best balances the need to collect
sufficient data, analyze the data, allows
us sufficient time to calculate the
provider/facility-specific total
performance scores, determine whether
providers and facilities meet the
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performance standards, prepare the
pricing files needed to implement
applicable payment reductions
beginning on January 1, 2012, and allow
providers and facilities time to preview
their performance scores and inquire
about their scores prior to finalizing
their scores and making performance
data public (discussed in section II.D. of
this proposed rule). We emphasize that
providers/facilities are already required
to submit all the necessary data needed
to calculate the measures as part of their
Medicare claims, so this proposal will
not create any new requirements. We
seek public comments about the
selection of CY 2010 as the initial
performance period.
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D. Methodology for Calculating the
Total Performance Score for the ESRD
QIP Measures
Section 1881(h)(3)(A)(i) of the Act
requires the Secretary to develop a
methodology for assessing the total
performance of each provider and
facility based on the performance
standards with respect to the measures
selected for a performance period.
Section 1881(h)(3)(A)(iii) of the Act
states that the methodology must also
include a process to weight the
performance scores with respect to
individual measures to reflect priorities
for quality improvement, such as
weighting scores to ensure that
providers/facilities have strong
incentives to meet or exceed anemia
management and dialysis adequacy
performance standards, as determined
appropriate by the Secretary. In
addition, section 1881(h)(3)(B) of the
Act requires the Secretary to calculate
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separate performance scores for each
measure. Finally, under section
1881(h)(3)(A)(ii) of the Act, for those
providers and facilities that do not meet
(or exceed) the total performance score,
the Secretary is directed to ensure that
the application of the scoring
methodology results in an appropriate
distribution of reductions in payments
to providers and facilities, with
providers and facilities achieving the
lowest total performance scores
receiving the largest reductions.
We propose to calculate the total
performance of each provider and
facility with respect to the measures we
have adopted for the initial performance
period by assigning 10 points to each of
the three measures. That is, if a provider
or facility meets or exceeds the
performance standard for one measure,
then it would receive 10 points for that
measure. We propose to award points
on a 0 to 10 point scale because this
scale is commonly used in a variety of
settings and we believe it can be easily
understood by stakeholders. We also
believe that the scale provides sufficient
variation to show meaningful
differences in performance between
providers/facilities.
We propose that a provider or facility
that does not meet or exceed the initial
performance standard for a measure
based on its 2010 data would receive
fewer than 10 points for that measure,
with the exact number of points
corresponding to how far below the
initial performance standard the
provider/facility’s actual performance
falls. Specifically, we propose to
implement a scoring methodology that
subtracts 2 points for every 1 percentage
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point the provider or facility’s
performance falls below the initial
performance standard. For example, if
under the special rule, the initial
performance standard for a particular
provider or facility for the Hemoglobin
More Than 12 g/dL is set under section
1881(h)(4)(E)(ii) as the 2008 national
average rate (26 percent), then if that
provider/facility had 28 percent of
Medicare patients with hemoglobin
levels greater than 12 g/dL during 2010
(the initial performance period), the
provider/facility would receive 6 points
for its performance on the measure
because 28 percent is 2 percentage
points below the performance standard
(see Table 1, which also illustrates how
the scoring would work if the
Hemoglobin Less Than 10 g/dL was set
under section 1881(h)(4)(E)(ii) as the
2008 national average rate (2 percent)).
However, if the initial performance
standard for the provider/facility is set
under section 1881(h)(4)(E)(i) as the
provider or facility’s actual performance
during 2007 (for purposes of this
example, 30 percent), the provider/
facility would receive 10 points for this
measure so long as its performance
during 2010 (the initial performance
period) was not worse than 30 percent
(see Table 2, which also illustrates how
the scoring would work if the
Hemoglobin Less Than 10 g/dL was set
under section 1881(h)(4)(E)(i) as the
facility’s actual performance during
2007 (for purposes of the example, 4
percent)). Tables 3 and 4 illustrate how
scores would be assigned for the
Hemodialysis Adequacy Measure.
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Than 12 g/dL measure. The table below
highlights the variability in performance
associated with each measure. (We note
that lower scores on the anemia
measures reflect better performance.)
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with each measure. For example, based
on 2008 data, a 1 percentage point
difference under the Hemoglobin Less
Than 10 g/dL measure would affect a
greater proportion of facilities and
providers than a 1 percentage point
difference under the Hemoglobin More
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We note that our proposed
methodology—that is, subtracting 2
points for every 1 percentage point the
provider or facility’s performance falls
below the performance standard—does
not take into account the relative
variability in performance associated
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Despite this difference in variability
in performance among the measures, we
are proposing to apply the straightforward methodology we have described
above in a manner that is consistent
across all three measures adopted in this
rule. In designing the scoring
methodology for the first year, CMS
wanted to adopt a clear-cut approach
(that is, subtracting two points for each
percentage point providers and facilities
fell below their performance standard)
consistent with the conceptual model
published in the End-Stage Renal
Disease Prospective Payment System
Final Rule (CMS–1418–F) on August 12,
2010 in the Federal Register. We seek
public comment on our proposal to
apply the score reductions in this
manner, as opposed to a methodology
which takes into account the relative
variation in performance that exists for
each measure.
We recognize that this straightforward approach may not be
appropriate in future years of the QIP as
we adopt new measures for inclusion in
the program that may have a wider
variability in performance. Moreover,
we may need to reevaluate this
approach for the three measures
adopted in this rule, depending on how
providers and facilities perform in
future years on these measures. If this
approach is finalized, we will continue
to evaluate the applicability and
appropriateness of such an approach in
future years of the QIP. As we have
stated, we want to ensure that the
performance measures included in the
QIP will result in meaningful quality
improvement for patients at both the
national and individual facility/
provider level. Therefore, we seek
comment on potential methodologies
that would take into account variation
in performance amongst all measures
included in the QIP. For example, under
one possible methodology, a provider or
facility’s performance could be awarded
10 points for achieving a higher level of
performance (for example, the 90th
percentile). The remaining points could
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then be assigned according to a linear
distribution, where a provider/facility
might receive 0 points for a lower level
of performance (for example, 1 standard
deviation below the mean).
In calculating the total performance
score, section 1881(h)(3)(A)(iii) of the
Act requires the agency to weight the
performance scores with respect to
individual measures to reflect priorities
for quality improvement, such as
weighting scores to ensure that
providers/facilities have strong
incentives to meet or exceed the
performance standards. In the
development of our conceptual model,
we initially considered that the initial
scoring method would weight each of
the three proposed measures equally.
After further examination and based on
the public comments received, we
propose to give greater weight to the
Hemoglobin Less Than 10 g/dL
measure. Low hemoglobin levels below
10 g/dL can lead to serious adverse
health outcomes for ESRD patients such
as increased hospitalizations, need for
transfusions, and mortality. Giving more
weight to the Hemoglobin Less Than 10
g/dL measure ensures that providers/
facilities are incentivized to continue to
properly manage and treat anemia. We
believe that this is important in light of
concerns that have been raised that the
new bundled ESRD payment system
could improperly incentivize providers/
facilities to undertreat patients with
anemia by underutilizing ESAs.
Specifically, we propose to weight the
Hemoglobin Less Than 10 g/dL measure
as 50 percent of the total performance
score. The remaining 50 percent of the
total performance score would be
divided equally between the
Hemoglobin More Than 12 g/dL
measure and the Hemodialysis
Adequacy Measure. When calculating
the total performance score for a
provider/facility, we would first
multiply the score achieved by that
provider/facility on each measure (0–10
points) by that measure’s assigned
weight (.50 or .25). Then we would add
each of the three numbers together,
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resulting in a number (although not
necessarily an integer) between 0–10.
Lastly, this number would be multiplied
by the number of measures (three) and
rounded to the nearest integer (if
necessary). In rounding, any fractional
portion 0.5 or greater would be rounded
up to the next integer, while fractional
portions less than 0.5 are rounded
down. Thus, a score of 27.4 would
round to 27, while 27.6 would round to
28.
An example of how the proposed
scoring methodology would work
follows below. The example assumes
that the performance standard for
Facility A during the initial
performance period is based on the 2008
national average rates under section
1881(h)(4)(E)(ii) of the Act (which are
set forth above) (because Facility A’s
base utilization year results were higher
than the 2008 national average) and that
Facility A achieves the following results
in 2010:
1. Hemoglobin Less Than 10 g/dL: 2
percent.
2. Hemoglobin More Than 12 g/dL: 26
percent.
3. Hemodialysis Adequacy: 93
percent.
The total performance score for
Facility A would be 26 points. Facility
A would receive 10 points for achieving
the 2008 national average rate for the
Hemoglobin Less Than 10 g/dL measure
(see Table 1); 10 points for achieving the
2008 national average rate for the
Hemoglobin More Than 12 g/dL
measure (see Table 1); and 4 points for
performing 3 percentage points below
the 2008 national average rate for the
Hemodialysis Adequacy Measure in
2010. Next, we would multiply each
individual measure’s score by its
assigned weight: 10 × .5 = 5; 10 × .25
= 2.5; 4 × .25 = 1. Then, all three scores
would be added together and multiplied
by three: (5 + 2.5 + 1) × 3 = 25.5. Finally,
we would round Facility A’s score to
the nearest whole number, resulting in
a total performance score of 26 points
(see Table 6 below).
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Table 4). In that case, Facility A’s score
of 93 percent during the performance
period would have earned it a score of
10 points, resulting in a total
performance score of 30 points (see
Table 7 below).
As we stated above, we believe that
this proposed weighting methodology
will ensure that providers/facilities have
the incentive to adequately maintain
patients’ hemoglobin levels, particularly
considering concerns about appropriate
ESA use that could arise when the new
bundled ESRD payment system is
implemented. We believe this proposed
weighting methodology is appropriate
for the initial year of the QIP. However,
consistent with our desire to improve
the quality of care provided to ESRD
patients, we solicit comments on
potential weighting methodologies that
could be incorporated to the QIP in
future years as new measures are
introduced.
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performance in 2007 on the
Hemodialysis Adequacy Measure had
been 92 percent, then its performance
standard for that measure would have
been set according to section
1881(h)(4)(E)(i), therefore setting a lower
performance standard for Facility A (see
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It is important to note that this
example assumes that Facility A’s
facility specific performance in 2007
(the base utilization year) on each of the
three measures was better than or equal
to the national performance average in
2008. If however, Facility A’s
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E. Payment Reductions Using the Total
Performance Score
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
reductions in payments among
providers and facilities achieving
different levels of total performance
scores, with providers and facilities
achieving the lowest total performance
scores receiving the largest reductions.
We propose to implement a sliding
scale of payment reductions for
payment consequence year 2012, where
the minimum total performance score
that providers/facilities would need to
achieve in order to avoid a payment
reduction would be 26 points.
Providers/facilities that score between
21–25 points would receive a 0.5
percent payment reduction, between
16–20 points a 1.0 percent payment
reduction, between 11–15 points a 1.5
percent payment reduction, and
between 0–10 points the full 2.0 percent
payment reduction (see Table 8).
Applying this payment reduction scale
to the example of Facility A above,
Facility A’s total performance score of
26 would result in it receiving no
payment reduction.
In developing the proposed payment
reduction scale, we carefully considered
the size of the incentive to providers/
facilities to provide high quality care
and range of total performance scores to
which the payment incentive applies,
recognizing that this would be the first
year of a new program. Our goal is to
avoid situations where small
deficiencies in a provider/facility’s
performance results in a large payment
reduction. For example, we want to
avoid imposing a large payment
reduction on providers/facilities whose
performance on one or more measures
falls just slightly below the performance
standard. At the same time, we want
poorly performing providers/facilities to
receive a more significant payment
reduction. Our analysis suggests that
use of payment differentials of 0.5
percent for the total performance score
ranges we are proposing differentiates
between providers/facilities with fair to
good performance and providers/
facilities with poor performance. We
will consider smaller differentials
between payment levels for future years
of the QIP, which we believe will
further differentiate providers/facilities
based on their performance.
Additionally, section 1881(h)(1)(A) of
the Act requires that the Secretary
implement payment reductions of up to
2.0 percent, and section
1881(h)(3)(A)(ii) requires that the
application of the total performance
score methodology result in an
appropriate distribution of reductions in
payment among providers/facilities.
Consistent with these requirements, we
believe that Medicare beneficiaries will
be best served if the full 2.0 percent
payment reduction is initially applied
only to those providers/facilities whose
performance falls well below the
performance standards. We believe that
applying a payment reduction of 2.0
percent to providers/facilities whose
performance falls significantly below
the performance standards, coupled
with applying 0.5 payment differential
reductions to providers/facilities based
on lesser degrees of performance
deficiencies, will incentivize all
providers/facilities to improve the
quality of their care and avoid a
payment reduction the following year.
We seek public comments about how
the proposed payment reduction scale
will incentivize providers/facilities to
meet or exceed the performance
standards for the first year of the QIP,
and whether it is an appropriate
standard to use in future years.
In general, ESRD facilities are paid
monthly by Medicare for the ESRD
services they furnish to a beneficiary
even though payment is on a per
treatment basis. In finalizing the new
bundled payment system starting on
January 1, 2011, we elected to continue
the practice of paying ESRD facilities
monthly for services furnished to a
beneficiary in the End-Stage Renal
Disease Prospective Payment System
Final Rule (CMS–1418–F) published on
August 12, 2010.
In keeping with this practice, we
propose to apply any payment reduction
under the QIP for payment consequence
year 2012 to the monthly payment
amount received by ESRD facilities and
providers. The payment reduction
would be applied after any other
applicable adjustments to an ESRD
facility’s payment, including case-mix,
wage index, outlier, etc, were made.
(This includes providers/facilities being
paid a blended amount under the
transition and those that had elected to
be excluded from the transition and
receive its payment amount based
entirely on the payment amount under
the ESRD PPS.)
Section 1833 of the Act governs
payments of benefits for Part B services
and the cost sharing amounts for
services that are considered medical and
other health services. In general, many
Part B services are subject to a payment
structure that requires beneficiaries to
be responsible for a 20 percent coinsurance after the deductible (and
Medicare pays 80 percent). With respect
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As previously discussed, we believe
this proposed total performance score
methodology is appropriate for the
initial performance period in the new
ESRD QIP, but recognize that it will be
important to monitor and potentially
reevaluate this methodology as provider
and facility performance changes and as
new measures are added in future years
of the ESRD QIP. We seek public
comments about the proposed scoring
methodology for the ESRD QIP.
Federal Register / Vol. 75, No. 155 / Thursday, August 12, 2010 / Proposed Rules
to dialysis services furnished by ESRD
facilities to individuals with ESRD,
under section 1881(b)(2)(a) of the Act,
payment amounts are 80 percent (and
20 percent by the individual).
Under the proposed approach for
implementing the QIP payment
reductions, the beneficiary co-insurance
amount would be 20 percent of the total
Medicare ESRD payment, after any
payment reductions are applied. To the
extent a payment reduction applies, we
note that the beneficiary’s co-insurance
amount would be calculated after
applying the proposed payment
reduction and would thus lower the coinsurance amount. We seek public
comment on the impact of this effect.
We propose to incorporate the
statutory requirements of the QIP
payment reduction set forth in proposed
§ 413.177.
F. Public Reporting Requirements
1. Introduction
Section 1881(h)(6)(A) of the Act
requires the Secretary to establish
procedures for making information
regarding performance under the ESRD
QIP available to the public, including
information on the total performance
score (as well as appropriate
comparisons of providers and facilities
to the national average with respect to
such scores) and performance scores for
individual measures achieved by each
provider and facility. Section
1881(h)(6)(B) further requires that a
provider or facility has an opportunity
to review the information to be made
public with respect to it prior to its
publication.
In addition, section 1881(h)(6)(C) of
the Act requires the Secretary to provide
each provider and facility with a
certificate containing its total
performance score to post in patient
areas within their facility. Finally,
section 1881(h)(6)(D) of the Act requires
the Secretary to post a list of providers/
facilities and performance-score data on
a CMS-maintained Web site.
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2. Notifying Providers/Facilities of Their
QIP Scores
Section 1881(h)(6)(B) of the Act
requires CMS to establish procedures
that include giving providers/facilities
an opportunity to review the
information that is to be made public
with respect to the provider or facility
prior to such data being made public.
CMS currently uses a secure, webbased tool to share confidential, facilityspecific quality data with providers,
facilities, and select others. Specifically,
we provide annual Dialysis Facility
Reports (DFRs) to dialysis providers/
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facilities, ESRD Network Organizations,
and State Survey Agencies. The DFRs
provide valuable facility-specific and
comparative information on patient
characteristics, treatment patterns,
hospitalizations, mortality, and
transplantation patterns. In addition, the
DFRs contain actionable practice
patterns such as dose of dialysis,
vascular access and anemia
management. We expect providers and
facilities to use the data included in the
DFRs as part of their ongoing clinical
quality improvement projects.
The information contained in DFRs is
sensitive and as such, most of that
information is made available through a
secure Web site only to that provider/
facility and its ESRD Network
Organization, State Survey Agency, and
the applicable CMS Regional Office.
However, select measures based on DFR
data are made available to the public
through the DFC Web site, which allows
Medicare beneficiaries and others to
review and compare characteristics and
quality information on dialysis
providers and facilities in the United
States. To allow dialysis providers/
facilities a chance to ‘‘preview’’ these
data before they are released publicly,
we supply draft DFRs to providers/
facilities in advance of every annual
DFC update. Dialysis providers and
facilities are generally provided 30 days
to review their facility-specific data and
submit comments if the provider/facility
has any questions or concerns regarding
the report. A provider/facility’s
comment is evaluated and researched. If
a provider/facility makes us aware of an
error in any DFR information, a
recalculation of the quality
measurement results for that provider/
facility is conducted, and the revised
results are displayed in the DFC Web
site.
We propose to use the abovedescribed procedures, including the
DFRs framework, to allow dialysis
providers/facilities to preview their
quality data under the QIP before they
are reported publicly. Specifically, the
quality data available for preview
through the web system will include a
provider/facility’s performance score
(both in total and by individual quality
measure) as well as a comparison of
how well the provider/facility’s
performance scores compare to national
averages for total performance and
individual quality measure
performance. We believe that adapting
these existing procedures for purposes
of the ESRD QIP will create minimum
expense and burden for providers/
facilities because they will not need to
familiarize themselves with a new
system or process for obtaining and
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commenting upon their preview reports.
We also note that under these
procedures, dialysis providers and
facilities would have an opportunity to
submit performance score inquiries and
to ask questions of CMS data experts
about how their performance scores
were calculated on a facility-level basis.
This performance score inquiry process
would also give providers/facilities the
opportunity to submit inquiries,
including what they believe to be errors
in their performance score calculations,
prior to the public release of the
performance scores. Any provider/
facility that submits an inquiry will
receive a response.
While we believe that the DFR
process is the most logical solution for
meeting the data preview requirement at
this time, we may decide to revise this
approach in the future. Should we
decide to make changes, or should we
find a more administratively feasible or
cost-effective solution, we propose to
use sub-regulatory processes to revise
our approach for administering the QIP
performance score preview process in a
way that maintains our compliance with
section 1881(h)(6)(B) of the Act. We also
propose to use sub-regulatory processes
to determine issues such as the length
of the preview period and the process
we will use to address inquiries
received from dialysis providers/
facilities during the preview period.
We seek public comments on our
proposal to use the DFR process and
suggestions for other options that will
allow dialysis providers/facilities to
preview the information that is to be
made public with respect to the
provider or facility in advance of such
information being made public.
3. Informing the Public Through
Facility-Posted Certificates
Section 1881(h)(6)(C) of the Act
requires the Secretary to provide
certificates to dialysis providers and
facilities about their total performance
scores under the QIP. This section also
requires each provider/facility that
receives a QIP certificate to display it
prominently in patient areas.
We propose to meet this requirement
by providing providers and facilities
with an electronic file in a generally
accessible format (for example,
Microsoft Word and/or Adobe Acrobat).
We propose to disseminate these
certificates to providers and facilities
once per year after the preview period
for the QIP performance scores has been
completed. We would use a secure,
web-based system, similar to the system
used to allow facilities to preview their
QIP performance scores, to disseminate
certificates. The secure web-based
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system would allow CMS to transmit
performance score certificates to
providers/facilities in a secure manner.
CMS will make every effort to
synchronize the release of the
certificates for provider/facility display
with the release of performance score
information on the Internet.
Under our proposal, each provider/
facility would be required to display the
certificate no later than 5 business days
after CMS sends it. We expect that
dialysis providers/facilities would have
the capability to download and print
their certificates from the secure Web
site. We propose that providers/facilities
would be prohibited from altering the
content of the certificates and that they
must print the certificates on plain,
blank, white or light-colored paper, no
smaller than 81⁄2 inches by 11 inches (a
standard-sized document). In addition,
providers/facilities may not reduce or
otherwise change the font size on the
certificate.
Once printed, we propose that each
provider/facility must post at least one
copy of the certificate prominently in a
patient area of the dialysis provider/
facility. Specifically, we propose that
providers/facilities must post the
certificate in a conspicuous place where
they post other patient-directed
materials so that it is in plain view for
all patients (or their parents/guardians
or representatives) to inspect. We will
update the certificates annually with
new performance information, and
providers/facilities must post the
updated certificate within 5 business
days of the day that we transmit it. We
expect that providers/facilities will take
steps to prevent certificates from being
altered, defaced, stolen, marred, or
covered by other material. In the event
that a certificate is stolen or destroyed
while it is posted, providers/facilities
would be responsible for replacing the
stolen or destroyed certificate with a
fresh copy by re-printing the certificate
file they have received from CMS. The
provider/facility would also be
responsible for answering patient
questions about the certificate in an
understandable manner, taking into
account that some patients might have
limited English proficiency.
We propose to include on the
certificate of each provider/facility all of
the information that we are also making
available to the public under sections
1881(h)(6)(A) and 1881(h)(6)(D) with
respect to the provider/facility. These
data elements are:
• The total performance score
achieved by the provider/facility under
the QIP with respect to the year
involved;
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• Comparative data that shows how
well the provider/facility’s total
performance score compares to the
national total performance score
average;
• The performance score that the
provider/facility achieved on each
individual measure with respect to the
year involved; and
• Comparative data that shows how
well the provider/facility’s individual
quality measure performance scores
compare to the national performance
score average for each quality measure.
We considered several options for
making QIP performance score data
available via certificates. Regarding the
content of the certificates, we
considered including not just
information for the ESRD QIP-related
quality measures, but additional quality
measure information that CMS has at its
disposal from the DFC Web site that is
not related to the QIP, such as riskadjusted survival information.
Ultimately, we determined that an
electronic method of disseminating
certificates was the easiest way for CMS
to deliver certificates directly to
providers/facilities because it is the
least burdensome and most cost
effective way of providing the
certificates. We also determined that the
information posted on the certificates
should be restricted only to QIP
information. We believe that limiting
the information on the certificate to QIPspecific data will make the certificate
easier for Medicare beneficiaries to read
and understand.
We seek public comments on how to
make the information contained on the
certificate as user friendly and easy to
understand as possible, and how to
make the information available to
Medicare beneficiaries who may be
unable to read the certificates due to a
physical disability or because of limited
or no reading proficiency in the English
language. We are particularly interested
in comments on how we can educate
Medicare beneficiaries and their
families about the presence of
certificates in dialysis providers/
facilities and how the information can
be used to engage in meaningful
conversations with their dialysis
caregivers and the clinical community
about the quality of America’s kidney
dialysis care.
Furthermore, we seek public
comments on the proposal to use the
DFR distribution process to provide the
certificates to providers/facilities under
section 1881(h)(6)(C) of the Act.
Specifically, we seek comments on the
feasibility and advisability of using the
DFR system to provide the certificates to
providers/facilities in a generally
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available format such as Microsoft Word
or Adobe Acrobat.
4. Informing the Public Through
Medicare’s Web Site
Section 1881(h)(6)(D) of the Act
requires the Secretary to use a CMSmaintained Web site for the purpose of
establishing a list of dialysis providers/
facilities that furnish renal dialysis
services to Medicare beneficiaries and
that indicates the total performance
score and the performance score for
individual measures achieved by the
provider or facility.
We currently use the DFC Web site (a
CMS-maintained Web site) to publish
information about the availability of
dialysis providers/facilities across the
United States, as well as data about how
well each of these providers/facilities
has performed on existing dialysisrelated quality of care measures. DFC is
part of a larger suite of ‘‘Compare’’ tools,
all of which are available online at
https://www.medicare.gov. In addition to
DFC, CMS hosts Nursing Home
Compare, Home Health Compare, and
Hospital Compare, as well as tools that
allow users to compare prescription
drug plans, health plans, and Medigap
policies.
DFC links Medicare beneficiaries with
detailed information about each of the
over 4,700 dialysis providers/facilities
approved by Medicare, and allows them
to compare providers/facilities in a
geographic region. Users can review
information about the size of the
provider/facility, the types of dialysis
offered, the provider/facility’s
ownership, and whether the provider/
facility offers evening treatment shifts.
Beneficiaries can also compare dialysis
providers/facilities based on three key
quality measures—how well patients at
a provider/facility have their anemia
managed, and how well patients at a
provider/facility have waste removed
from their blood during dialysis, and
whether the patients treated at a
provider/facility generally live as long
as expected. DFC aims to help
beneficiaries decide which dialysis
provider/facility would best serve their
care needs, as well as to encourage
conversations among beneficiaries and
their caregivers about the quality of care
at dialysis providers/facilities, thus
providing an additional incentive for
dialysis providers/facilities to improve
the quality of care they furnish. Lastly,
DFC links beneficiaries to resources that
support family members, as well as
beneficiary advocacy groups.
Because DFC is a current component
of the Medicare suite of Compare tools,
we propose to use DFC as the
mechanism for meeting the Web-based
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public information requirement under
section 1881(h)(6)(D) of the Act. DFC is
a consumer-focused tool, and the
implementation of the QIP will not
change this focus. We recognize that
sharing information with the public
about the QIP is not only a statutory
requirement: It is also a function of open
and transparent government. Ultimately,
the intent of DFC is to provide
beneficiaries with the information they
need to be able to make proper care
choices.
We believe that DFC already provides
accurate and trusted information about
the characteristics of all Medicareapproved dialysis providers/facilities, as
well as information about the quality of
care furnished by these providers/
facilities. Furthermore, CMS already has
the information technology
infrastructure in place to support DFC
and its public reporting functions;
therefore, adding new QIP-related data
to the DFC Web site would not create
additional significant expenditures or
overly burden agency resources.
We propose to update the DFC Web
site once per year at a minimum with
the following data elements for every
provider/facility listed on DFC (that is,
every Medicare-approved provider/
facility):
• The total performance score
achieved by each provider/facility
under the QIP with respect to the year
involved;
• Comparative data that shows how
well the provider/facility’s total
performance score compares to the
national total performance score
average;
• Scores for each of the individual
measures that comprise the overall QIP
performance score for the provider/
facility with respect to the year
involved; and
• Comparative data that shows how
well the provider/facility’s individual
quality measure performance scores
compare to the national performance
score average for each quality measure.
We note that this is the same
information that we are proposing to
include on the certificates that we will
provide to providers/facilities. We seek
public comments about whether the
total performance score and the
individual measure performance scores
should be integrated into the design of
the DFC tool itself or whether we should
alternatively implement section
1881(h)(6)(D) by making a file available
to the public on the CMS Web site (at
https://www.cms.hhs.gov). We are
sensitive to the need to balance our
interest in making QIP performance
score information public with our need
to provide beneficiaries with easy-to-
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understand, non-technical information
about providers/facilities that they can
use to make decisions about where to
receive dialysis care.
We also seek public comment on the
advisability of using DFC as our
mechanism for making QIP information
available over the Internet. We also seek
comment on the presentation of QIP
information on the Web site and the
breadth of detail that we should make
publicly available regarding QIP
performance scores. Lastly, we seek
comment on how DFC could be
redesigned to make QIP information
useful to Medicare beneficiaries as they
compare the quality of care available at
the nation’s Medicare-approved dialysis
providers/facilities.
III. Future QIP Considerations
A. Program Monitoring and Evaluation
CMS plans to monitor and evaluate
the new ESRD Prospective Payment
System (PPS) and QIP as part of our
ongoing effort to ensure that Medicare
beneficiaries with ESRD receive high
quality care. The monitoring will focus
on whether, following implementation
of the new PPS and the QIP, we observe
changes in access to and quality of care,
especially within the vulnerable
populations. We will be evaluating the
effects of the new PPS and the QIP in
areas such as:
• Access to care for beneficiaries
including categories or subgroups of
beneficiaries.
• Changes in care practices that could
adversely impact on the quality of care
for beneficiaries.
• Patterns of care suggesting
particular effects of the new PPS, for
example, whether there are increases/
decreases in utilization of injectable
ESRD drugs and the use of home
modalities for certain groups of ESRD
beneficiaries.
• Best practices of high-performing
providers/facilities that might be
adopted by other providers/facilities.
CMS currently collects detailed
claims data on patients’ hemoglobin
levels and adequacy of dialysis, and also
collects information on other facets of
ESRD care, including treatments
provided, drugs, hospitalizations, and
deaths. In addition, we collect
beneficiary enrollment data which
provide important demographic and
other information related to Medicare
ESRD beneficiaries. These data and
other data sources will provide the basis
for early examination of overall trends
in care delivery, access, and quality. We
also will use the data to assess more
fully the quality of care furnished to
Medicare beneficiaries under the new
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PPS, and to help inform possible
refinements to the PPS and QIP moving
forward. We welcome public comments
about an approach to monitoring and
evaluating the PPS and the QIP.
B. Potential QIP Changes and Updates
As noted above, section 1881(h)(4)(B)
of the Act provides that the performance
standards established under section
1881(h)(4)(A) shall include levels of
achievement and improvement, as
determined appropriate by the
Secretary. We anticipate that we will
propose to adopt performance standards
under section 1881(h)(4)(A) of the Act
that include levels of achievement and
improvement for the 2013 QIP.
In addition, we anticipate
strengthening the performance standard
for each measure in future years of the
QIP, including potentially moving away
from using the national performance
rate as the performance standard and
instead identifying absolute standards
that reflect performance goals widely
recognized by the ESRD medical
community as demonstrating high
quality care for ESRD patients. For
instance, we may seek to raise the
performance standard for each of the
three measures finalized for the 2012
QIP above the proposed or finalized
level (that is, Hemoglobin Less Than 10
g/dL—2 percent; Hemoglobin More
Than 12 g/dL—26 percent; and
Hemodialysis Adequacy Measure—96
percent).
Additionally, for these initial three
finalized measures, we intend to
establish the national performance rates
of each of these measures as ‘‘floors’’
such that the performance standards
will never be lower than those set for
the previous year; even if provider/
facility performance—and therefore the
national performance rate—fails to
improve, or even declines, over time,
the performance standard to which
facilities and providers will be held for
these measures will not be reduced from
one year to the next. This will better
ensure that the quality of ESRD patient
care will continue to improve over time.
Establishing such floors for performance
standards, however, will in no way
prohibit the Secretary from establishing
performance standards that are higher
than the floors if the Secretary
determines that higher performance
standards are appropriate.
In establishing new measures for the
QIP in future years, we intend that the
concept of ‘‘floors’’ described above
would be established for each new
measure and applied to these new
measures in order to better ensure
improvement in quality of care, once we
have a historical perspective on how the
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measure performs. While we will
consider use of national performance
rates, we also will take into
consideration future performance
measures that reflect performance goals
widely recognized by the ESRD medical
community as demonstrating high
quality care for ESRD patients, should
such a consensus be reached.
As noted above, section 1881(h)(2)(A)
of the Act also requires that the
measures include, to the extent feasible,
measures on patient satisfaction, as well
as such other measures that the
Secretary specifies, including iron
management, bone mineral metabolism
(i.e. for calcium and phosphorus), and
vascular access. CMS is currently
developing measures in each of the
areas specified in section 1881(h)(2)(A)
of the Act and is also developing
additional measures such as Kt/V,
access infection rate, fluid weight
management, and pediatric measures.
As part of the process of developing
these new measures, where necessary
data are not currently being collected,
we intend to require providers to submit
data needed to establish a baseline for
each of the measures under
consideration, as listed above, as soon
as is practicable. For most measures,
CMS will use a collection process that
has been determined appropriate by the
Secretary to obtain this data. For
collection of calcium and phosphorus
levels, however, we intend to collect
information on facility and provider
ESRD claims as soon as practicable.
Additional detail on submission of the
calcium and phosphorus levels will be
provided as soon as it is available. We
anticipate proposing additional
measures, such as those listed above
under section 1881(h)(2)(A) of the Act,
in future rulemaking for the QIP.
We seek public comments on how we
might best incorporate both
improvement and achievement
standards as specified by the Act. We
also seek comments on performance
standards for future years of the QIP. We
are committed to adopting additional
quality measures for the QIP as soon is
practicable. While we are evaluating
measures for inclusion in future years of
the QIP, we also seek public comment
on setting performance standards for the
first year a new measure is included in
the QIP.
IV. Collection of Information
Requirements
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
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and Budget (OMB) for review and
approval. In order to fairly evaluate
whether an information collection
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.
We are soliciting public comment on
each of these issues for the following
sections of this document that contain
information collection requirements
(ICRs):
Section VIII.C. of the preamble of this
proposed rule discusses a disclosure
requirement. As stated earlier in the
preamble, section 1881(h)(6)(C) of the
Act requires the Secretary to provide
certificates to dialysis care providers
and facilities about their total
performance scores under the QIP. This
section also requires each provider and
facility that receives a QIP certificate to
display it prominently in patient areas.
To comply with this requirement,
CMS will be issuing QIP certificates to
providers and facilities via a generally
accessible electronic file format. We
propose that each provider and facility
would prominently display the QIP
certificate in patient areas. In addition,
we propose that each provider and
facility will take the necessary measures
to ensure the security of the certificate
in the patient areas. Finally, we propose
that each provider/facility would have
staff available to answer questions about
the certificate in an understandable
manner, taking into account that some
patients might have limited English
proficiency.
The burden associated with the
aforementioned requirements is the time
and effort necessary for providers and
facilities to print the QIP certificates,
display the certificate prominently in
patient areas, ensure the safety of the
certificate, and respond to patient
inquiries in reference to the certificates.
We estimate that 4,311 providers and
facilities will receive QIP certificates
and will be required to display them.
We also estimate that it will take each
provider or facility 10 minutes to print,
prominently display and secure the QIP
certificate, for a total estimated annual
burden of 719 hours. We estimate that
approximately one-third of ESRD
patients will ask a question about the
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QIP certificate. We further estimate that
it will take each provider/facility 5
minutes to answer each patient question
about the QIP certificate, or 1.65 hours
per provider or facility each year. The
total estimated annual burden
associated with this requirement is
7,121 hours. The total estimated annual
burden for both displaying the QIP
certificates and answering patient
questions about the certificates is 7,839
hours. While the total estimated annual
burden associated with both of these
requirements as discussed is 7,839
hours, we do not believe that there will
be a significant cost associated with
these requirements because we are not
requiring facilities to complete new
forms. As discussed in Section VI. of the
preamble of this proposed rule, we
estimate that the total cost for all ESRD
facilities to comply with the collection
of information requirements would be
less than $200,000.
If you wish to comment on these
information collection and
recordkeeping requirements, please do
either of the following:
1. Submit your comments
electronically as specified in the
ADDRESSES section of this proposed rule;
or
2. Submit your comments to the
Office of Information and Regulatory
Affairs, Office of Management and
Budget, Attention: CMS Desk Officer,
[CMS–3206–P].
Fax: (202) 395–6974; or
E-mail:
OIRA_submission@omb.eop.gov.
V. 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.
VI. Regulatory Impact Statement
A. Overall Impact
We have examined the impact of this
rule as required by Executive Order
12866 on Regulatory Planning and
Review, 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) and the Congressional
Review Act (5 U.S.C. 804(2)).
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Executive Order 12866 directs
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). A regulatory impact
analysis (RIA) must be prepared for
major rules with economically
significant effects ($100 million or more
in any 1 year). As explained in the
analysis that follows, we have
determined that this proposed rule is
not economically significant since it
does not have effects of $100 million or
more. Furthermore, it is not considered
a major rule under the Congressional
Review Act.
The RFA requires agencies to analyze
options for regulatory relief of small
businesses. For purposes of the RFA,
small entities include small businesses,
nonprofit organizations, and small
governmental jurisdictions. Most
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hospitals and most other providers or
facilities are small entities, either by
nature of their nonprofit status or by
having revenues of $7.0 million to $34.5
million in any 1 year. Individuals and
States are not included in the definition
of a small entity. Based on our review
of 2007–2008 DFC quality performance
data, we estimate that approximately 19
percent of ESRD facilities are small
entities according to the Small Business
Administration’s (SBA) size standard of
those dialysis facilities having total
revenues of $34.5 million or less in any
one year, and that 19 percent of dialysis
facilities are nonprofit organizations.
For more information on SBA’s size
standards, see the SBA Web site at
https://sba.gov/idc/groups/public/
documents/sba_homepage/
serv_sstd_tablepdf.pdf. (Kidney Dialysis
Centers are listed as North American
Industry Classification System (NAICS)
Code 621492 with a size standard of
$34.5 million.)
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Using DFC performance data based on
Medicare claims from 2007 and 2008,
we consider the 802 independent
facilities and hospital-based facilities to
be small entities. The ESRD facilities
that are owned and operated by a Large
Dialysis Organization (LDO) and/or
regional chain, comprising
approximately 3,509 facilities, would
have total revenues in excess of $34.5
million in any year when the total
revenues for all locations are combined
for each business (individual LDO or
regional chain). Table 9 below shows
the estimated impact of the QIP on
small entities for payment consequence
year 2012. The distribution of ESRD
providers/facilities by facility size (both
among facilities considered to be small
entities for purposes of this analysis and
by number of treatments per facility),
geography (both urban/rural and by
region), and by facility type (hospital
based/freestanding facilities).
BILLING CODE 4120–01–P
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BILLING CODE 4120–01–C
SOURCE: Analysis of DFC/Medicare
claims data (2007–2008) for ESRD
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providers/facilities reporting data on all
three measures.
We note that guidance issued by the
Department of Health and Human
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Services interpreting the RFA considers
effects to be economically significant if
they reach a threshold of 3 to 5 percent
or more of total revenue or total costs.
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a substantial number of small rural
hospitals. This 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 for
Medicare payment regulations and has
fewer than 100 beds. We do not believe
this proposed rule has a significant
impact on operations of a substantial
number of small rural hospitals because
most dialysis facilities are freestanding.
Therefore, we are not preparing an
analysis for section 1102(b) of the Act
because the Secretary has determined
that this proposed rule will not have a
significant impact on the operations of
a substantial number of small rural
hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 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 2010, that threshold is approximately
$135 million. This rule will not have a
consequential effect on State, local, or
tribal governments in the aggregate, or
by the private sector of $135 million.
Executive Order 13132 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.
Since this regulation does not impose
any costs on State or local governments,
the requirements of Executive Order
13132 are not applicable.
To estimate the total payment
reductions in 2012 resulting from the
proposed rule for each facility, we
multiplied the number of patients
treated at each facility receiving a
reduction times an average of three
treatments per week. We then
multiplied this product by a base rate of
$229.63 per dialysis treatment (before
an adjustor is applied) to arrive at a total
ESRD payment for each facility:
((Number of patients treated at each
facility × 3 treatments per week) × base
rate)
Finally, we applied the estimated
payment reduction percentage expected
under the QIP, yielding a total payment
reduction amount for each facility:
(Total ESRD payment estimated
payment reduction percentage)
Totaling all of the payment reductions
for each of the 1,106 facilities expected
to receive a reduction leads to a total
payment reduction of approximately
$17.3 million for payment consequence
year 2012. Further, we estimate that the
total costs associated with the collection
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B. Anticipated Effects
This proposed rule is intended to
mitigate possible reductions in the
quality of ESRD dialysis facility services
provided to beneficiaries as a result of
payment changes under the ESRD PPS
by implementing a quality incentive
program (QIP) that would reduce ESRD
payments by up to 2 percent to dialysis
providers/facilities that fail to meet or
exceed a total performance score with
respect to performance standards
established by the Secretary with
respect to certain specified measures.
The methodology that we are proposing
to determine a provider/facility’s
performance score is described in
section VI (Methodology for Calculating
the Total Performance Score for the
ESRD QIP Measures). Any reductions in
ESRD payment would begin on January
1, 2012 for services furnished on or after
January 1, 2012.
The End-Stage Renal Disease
Prospective Payment System Final Rule
(CMS–1418–F) published on August 12,
2010 estimates payments to ESRD
facilities in 2012 to be $8.5 billion. The
calculations used to determine the
impact of this proposed rule reveal that
approximately 27 percent or 1,106 ESRD
dialysis facilities would likely receive
some kind of payment reduction for
2012. Again using DFC/Medicare claims
data from 2007–2008, Table 10 shows
the overall estimated distribution of
payment reductions resulting from the
2012 QIP.
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Under the proposed rule, the maximum
payment reduction applied to
providers/facilities, regardless of its
size, is 2.0 percent of aggregate
Medicare payments for dialysis services.
This falls below the 3.0 percent
threshold for economic significance
established by HHS. To further ascertain
the impact on small entities for
purposes of the RFA, we projected
provider/facility performance based on
DFC performance data from 2007 and
2008. For the 2012 QIP, of the 1,106
ESRD facilities expected to receive a
payment reduction, 252 small entities
would be expected to receive a payment
reduction (ranging from 0.5 percent up
to 2.0 of total payments). We expect
payment reductions received would
average approximately $18,000 per
facility, regardless of facility size. Using
our projections of provider/facility
performance, we next estimated the
impact of expected payment reductions
on small entities by comparing the total
payment reduction for the 252 small
entities expected to receive a payment
reduction with aggregate ESRD
payments to all small entities. For the
entire group of 802 small entities, a
minor decrease of 0.27 percent in
aggregate ESRD payments is observed.
Therefore, we are not preparing an
initial analysis for the RFA because the
Secretary has determined that this
proposed rule will not have a significant
economic impact on a substantial
number of small entities.
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
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of information requirements described
in Section IV. of the preamble of this
proposed rule would be less than
$200,000 for all ESRD facilities. As a
result, the estimated aggregate $17.5
million impact for 2012 does not reach
the $100 million threshold for an
economically significant rule.
C. Alternatives Considered
As stated above, this proposed rule
proposes to implement a QIP for
Medicare ESRD dialysis providers and
facilities with payment reductions
beginning January 1, 2012. Under
section 1881(h) of the Act, after
selecting measures, establishing
performance standards that apply to
each of the measures, specifying a
performance period, and developing a
methodology for assessing the total
performance of each provider and
facility based on the specified
performance standards, the Secretary is
required to apply an appropriate
reduction to ESRD providers and
facilities that do not meet or exceed the
established total performance score. In
developing the proposed QIP, we
carefully considered the size of the
incentive to providers and facilities to
provide high-quality care. We also
selected the measures adopted for the
2012 ESRD QIP because these measures
are important indicators of patient
outcomes and quality of care. Poor
management of anemia and inadequate
dialysis, for example, can lead to
avoidable hospitalizations, decreased
quality of life, and death. Thus, we
believe the measures selected will allow
CMS to continue focusing on improving
the quality of care that Medicare
beneficiaries receive from ESRD dialysis
providers and facilities.
We considered alternatives for
identifying the performance standard,
including the mean, median, and mode.
However, we determined that the
national average would be appropriate
for the first payment year for the reasons
listed below:
• CMS believes that the legislative
intent was to set the performance
standard at the ‘‘average’’, as this is the
performance standard that has been
publicly reported on the Dialysis
Facility Compare Web site (DFC) for the
past ten years and was the standard in
effect when the language was crafted;
• Recognizing however that there was
some flexibility, CMS reviewed other
possible standards and noted that there
was little difference in the range of
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performance, with the exception of
performance for Hemoglobin More Than
12 (Hgb <10–0%–3%; Hgb >12–8%–
38%; URR 94%–100%). As the bundled
payment will likely reverse the
incentive that may be leading to the
wider range for the Hgb>12, the
differences in the performance did not
warrant moving from the use of a
national average for performance.
• CMS has seen great improvement in
the rates for these measures over the
past several years in part due to public
reporting and continuous oversight and
monitoring. The rate for Hemoglobin
Less Than 10 has improved and
maintained improvement, while
Hemoglobin More Than 12 improved
from 44% in 2007 to 26% in 2008 as
demonstrated below. Should it become
evident that the rates begin to move in
the wrong direction due to the bundled
payment, different performance
standards can be proposed through
future rulemaking. For example, if the
national average for Hemoglobin Less
Than 10 began to drop, CMS could
propose to require a rate of 2% or less
regardless of the national average;
• The national average was also
selected because of the rapid
implementation date for the first year
and because the period of performance
for the first payment year has already
begun. We anticipate the final rule will
be published near the end of the
performance period. Therefore,
introduction of a new performance
standard after the period of performance
has nearly ended was not appropriate.
We also considered alternatives for
applying payment reductions. Our main
alternatives considered varying point
reductions based on each 1 percentage
point a facility or provider was below
the performance standard. We did not
propose alternatives that applied
payment reductions that accounted for
the variability seen within each
measure, and as noted above, we ask for
public comment on such alternatives.
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
List of Subjects in 42 CFR Part 413
Health facilities, Kidney diseases,
Medicare, Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services propose to amend 42
CFR chapter IV as set forth below:
PO 00000
Frm 00018
Fmt 4701
Sfmt 9990
PART 413—PRINCIPLES OF
REASONABLE COST
REIMBURSEMENT; PAYMENT FOR
END-STAGE RENAL DISEASE
SERVICES; OPTIONAL
PROSPECTIVELY DETERMINED
PAYMENT RATES FOR SKILLED
NURSING FACILITIES
1. The authority citation for part 413
continues to read as follows:
Authority: Secs. 1102, 1812(d), 1814(b),
1815, 1833(a), (i), and (n), 1861(v), 1871,
1881, 1883, and 1886 of the Social Security
Act (42 U.S.C. 1302, 1395d(d), 1395f(b),
1395(g), 1395I(a), (i), and (n), 1395x(v),
1395hh, 1395rr, 1395tt, and 1395ww); and
sec. 124 of Public Law 106–113 (133 stat.
1501A–332).
Subpart H—Payment for End-Stage
Renal Disease (ESRD) Services and
Organ Procurement Costs
2. Section 413.177 is added to subpart
H to read as follows:
§ 413.177 Quality Incentive Program
Payment.
(a) With respect to renal dialysis
services as defined under § 413.171 of
this part, in the case of a provider of
services or a renal dialysis facility that
does not meet the performance
requirements described in section
1881(h)(1)(B) of the Act for the
performance year, payments otherwise
made to the provider or facility under
this subpart for renal dialysis services
will be reduced by up to 2.0 percent, as
determined appropriate by the
Secretary.
(b) Any payment reduction will apply
only to services provided in the
payment year involved and will not be
taken into account in computing the
single payment amount under this
subpart for services provided in a
subsequent payment year.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: March 18, 2010.
Marilyn Tavenner,
Acting Administrator and Chief Operating
Officer, Centers for Medicare & Medicaid
Services.
Approved: July 19, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010–18465 Filed 7–26–10; 4:15 pm]
BILLING CODE 4120–01–P
E:\FR\FM\12AUP2.SGM
12AUP2
Agencies
[Federal Register Volume 75, Number 155 (Thursday, August 12, 2010)]
[Proposed Rules]
[Pages 49215-49232]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18465]
Federal Register / Vol. 75, No. 155 / Thursday, August 12, 2010 /
Proposed Rules
[[Page 49215]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 413
[CMS-3206-P]
RIN 0938-AP91
Medicare Program; End-Stage Renal Disease Quality Incentive
Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule proposes to implement a quality incentive
program (QIP) for Medicare outpatient end-stage renal disease (ESRD)
dialysis providers and facilities with payment consequences beginning
January 1, 2012, in accordance with section 1881(h) of the Act (added
on July 15, 2008 by section 153(c) of the Medicare Improvements for
Patients and Providers Act (MIPPA)). The proposed ESRD QIP would reduce
ESRD payments by up to 2.0 percent for dialysis providers and
facilities that fail to meet or exceed a total performance score for
performance standards established with respect to certain specified
measures.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. eastern standard
time (EST) on September 24, 2010.
ADDRESSES: In commenting, please refer to file code CMS-3206-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 instructions under
the ``More Search Options'' tab.
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-3206-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-3206-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to either of the following addresses:
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 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
Submission of comments on paperwork requirements. This document
does not propose any paperwork requirements in the ``Collection of
Information Requirements'' section in this document.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Lynn Riley, (410) 786-1286.
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.
Table of Contents
I. Background
A. Evolution of Quality Monitoring Initiatives
B. Statutory Authority for ESRD QIP
C. Selection of the ESRD QIP Measures
II. Provisions of the Proposed Rule
A. Overview of the Proposed ESRD QIP
B. Performance Standards for the ESRD QIP Measures
C. Performance Period for the ESRD QIP Measures
D. Methodology for Calculating the Total Performance Score for
the ESRD QIP Measures
E. Payment Reductions Using the Total Performance Score
F. Public Reporting Requirements
1. Introduction
2. Notifying Providers/Facilities of Their QIP Scores
3. Informing the Public Through Facility-Posted Certificates
4. Informing the Public Through Medicare's Web Site
III. Future QIP Considerations
A. Program Monitoring and Evaluation
B. QIP Changes and Updates
IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impact Analysis
A. Overall Impact
B. Anticipated Effects
C. Alternatives Considered
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:
CIP Core Indicators Project
CMS Centers for Medicare & Medicaid Services
CPM Clinical performance measure
CROWNWeb Consolidated Renal Operations in a Web-Enabled Network
DFC Dialysis Facility Compare
DFR Dialysis Facility Report
ESA Erythropoiesis stimulating agent
ESRD End stage renal disease
FDA Food and Drug Administration
Kt/V A measure of dialysis adequacy where K is dialyzer clearance, t
is dialysis time, and V is total body water volume
LDO Large dialysis organization
MIPPA Medicare Improvements for Patients and Providers Act of 2008
(Pub. L. 110-275)
NQF National Quality Forum
PPS Prospective payment system
QIP Quality incentive program
[[Page 49216]]
REMIS Renal management information system
RFA Regulatory Flexibility Act
SIMS Standard information management system
SSA Social Security Administration
the Act Social Security Act
URR Urea reduction ratio
I. Background
A. Evolution of Quality Monitoring Initiative
Monitoring the quality of care provided to ESRD patients and
provider/facility accountability are important components of the
Medicare ESRD payment system and have been priorities for over 30
years. We will describe the evolution of our ESRD quality monitoring
initiatives by category below.
1. ESRD Network Organization Program
In the End-Stage Renal Disease Amendments of 1978 (Pub. L. 95-292),
Congress required the formation of ESRD Network Organizations to
further support the ESRD program. CMS currently contracts with 18 ESRD
Networks throughout the United States to perform oversight activities
and to assist dialysis providers and facilities in providing
appropriate care for their dialysis patients. The Networks'
responsibilities include monitoring the quality of care provided to
ESRD patients, providing technical assistance to patients who have ESRD
and to providers/facilities that treat ESRD patients to assist them in
improving care, addressing patient complaints and/or grievances, and
emergency preparedness. In 1994, CMS and the ESRD Networks, with input
from the renal community, established the ESRD Core Indicators Project
(CIP). The ESRD CIP was CMS's first nationwide population-based study
designed to assess and identify opportunities to improve the care of
patients with ESRD. This project established the first consistent
clinical ESRD database. Information in this database included clinical
measures thought to be indicative of key components of care provided to
individuals who required dialysis. The initial Core Indicators focused
on adult hemodialysis patients who received care in dialysis
facilities. The Core Indicators included measures related to anemia
management, adequacy of hemodialysis, nutritional status and blood
pressure control. On March 1, 1999, the ESRD CIP was merged with the
ESRD Clinical Performance Measures (CPM) Project (described below).
2. Clinical Performance Measures (CPM) Project
Section 4558(b) of the Balanced Budget Act of 1997 required CMS to
develop and implement, by January 1, 2000, a method to measure and
report the quality of renal dialysis services furnished under the
Medicare program. To implement this legislation, CMS developed the ESRD
Clinical Performance Measures (CPM) Project based on the National
Kidney Foundation's Dialysis Outcome Quality Initiative (NKF-DOQI)
Clinical Practice Guidelines. The purpose of collecting and reporting
the ESRD CPMs was to enable us to provide comparative data to ESRD
providers/facilities to assist them in assessing and improving the care
furnished to ESRD patients.
3. Dialysis Facility Compare (DFC)
Also in response to the Balanced Budget Act of 1997, CMS created
Dialysis Facility Compare (DFC) as a new feature on https://www.medicare.gov that was modeled after Nursing Home Compare and
continues to be used by CMS today. CMS worked with a contractor and a
consumer workgroup to identify dialysis facility-specific measures that
could be provided to the public for consumer choice and information
purposes. This tool was launched in January 2001 on the https://www.medicare.gov/Dialysis Web site to provide information to the public
for comparing the quality of dialysis facilities across the country,
including specific information about services available and the quality
of care furnished by a specific dialysis facility/provider. DFC
captures administrative and quality related data submitted by dialysis
facilities and providers.
The quality measures initially reported on DFC were measures of
anemia control, adequacy of hemodialysis treatment and patient
survival. Medicare claims data were used to calculate the anemia
management and hemodialysis adequacy rates, and administrative data
(non-clinically based data such as demographic data, and data acquired
from the Social Security Administration (SSA) and obtained from the CMS
forms 2728 and 2746) were used to determine patient survival rates. The
anemia measure assessed the percentage of Medicare patients receiving
an erythropoiesis-stimulating agent (ESA) at a given provider/facility
whose anemia (low red blood cell count) was not controlled. More
specifically, the anemia measure when DFC was launched in January 2001
assessed the percentage of Medicare patients whose hematocrit levels
were at 33 percent (33 percent out of 100 percent) or more (or
hemoglobin levels of 11 g/dL or more). Since that time, evidence about
increased risk of certain adverse events associated with the use of
ESAs, which are used to treat anemia, raised concerns about patients
who have hemoglobin levels that are too high, as well as patients whose
hemoglobin levels are too low. The Food and Drug Administration (FDA)
responded by requiring manufacturers to develop a Medication Guide
(https://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm054716.htm) and to ensure that this information is provided to
patients. The labeling guideline for ESAs states ``The dosing
recommendations for anemic patients with chronic renal failure have
been revised to recommend maintaining hemoglobin levels within 10 g/dL
to 12 g/dL''. As a result of this guideline, in November 2008 DFC was
revised to include two anemia measures: one measure shows the
percentage of patients whose hemoglobin levels are considered too low
(that is, below 10 g/dL), and a second measure shows the percentage of
patients whose hemoglobin levels are too high (that is, above 12 g/dL).
The dialysis adequacy measure assesses the percentage of in-center
hemodialysis Medicare patients treated by the facility who had enough
wastes removed from their blood during dialysis. More specifically, the
measure is the percentage of Medicare patients with urea reduction
ratio (URR) levels of 65 percent or more. The patient survival measure
indicates general facility survival as better than expected, as
expected, or worse than expected. These measures are updated annually
on the DFC Web site, usually at the end of the year, using Medicare
claims data from the previous year for the hemodialysis adequacy and
anemia measures and Medicare administrative data from the past 4 years
for the patient survival measure.
4. ESRD Quality Initiative
In 2004, the ESRD Quality Initiative was launched and continues
today. The objective is to stimulate and support significant
improvements in the quality of dialysis care. The initiative aims to
refine and standardize dialysis care measures, ESRD data definitions,
and data transmission to support the needs of the ESRD program; empower
patients and consumers by providing access to facility service and
quality information; provide quality improvement support to dialysis
facilities and providers; assure compliance with conditions of
coverage; and build strategic partnerships with
[[Page 49217]]
patients, providers/facilities, professionals, and other stakeholders.
Components of this Quality Initiative include the DFC, and the CPM
Project.
5. ESRD Conditions for Coverage
On April 15, 2008, we published in the Federal Register, the
updated ESRD Conditions for Coverage final rule, which contains revised
requirements that dialysis providers and facilities must meet in order
to be approved by Medicare and receive payment (73 FR 20370 April 15,
2008). As part of the revised requirements, dialysis providers and
facilities are each required to implement their own quality assessment
and performance improvement program. In addition, providers and
facilities are required to submit electronically the CPMs developed
under the ESRD CPM Project for all Medicare patients on an annual
basis. The CPMs were updated and expanded in April 2008. The current
CPMs include 26 measures in the areas of anemia management;
hemodialysis adequacy; peritoneal dialysis adequacy; mineral
metabolism; vascular access; patient education/perception of care/
quality of life; and patient survival.
6. CROWNWeb
CMS has developed a new web-based system, Consolidated Renal
Operations in a Web-Enabled Network (CROWNWeb) for the purposes of
electronically collecting information about patients, facilities,
providers, and clinical data to support the CPM Project. CROWNWeb
supports the mineral metabolism, anemia management, hemodialysis
adequacy, peritoneal dialysis adequacy, survival, and type of vascular
access CPMs. Use of the CROWNWeb system will increase the efficiency of
data collection for both CMS and providers/facilities, improve data
quality, and provide a more stable and accessible platform for
continual improvements in functionality. In February 2009, for Phase
one, we began implementing the CROWNWeb system with a number of
providers/facilities testing the system and expanded reporting to
additional providers/facilities in July 2009 for Phase two.
During these initial phases, nearly 200 dialysis providers/
facilities (representing a cross section of small independent
facilities and large dialysis organizations (LDOs)) were selected to
enter data into CROWNWeb. These providers/facilities worked closely
with CMS, their respective ESRD Networks, and CROWNWeb development and
support contractors to understand the requirements of CROWNWeb, and to
refine the internal business processes and procedures used to submit
data effectively and efficiently into the system.
The successful launch of both Phase One and Phase Two and helpful
feedback provided by users has enabled CMS to work on additional
upgrades to CROWNWeb that address both the technical and usability
elements of the system. We continue to further refine the system as an
additional tool for quality improvement.
7. QIP Conceptual Model
On September 29, 2009, we published in the Federal Register (74 FR
49922), the ESRD Prospective Payment System (PPS) proposed rule,
describing how the Agency proposes to implement the new ESRD PPS in
2011. As part of that proposed rule, we outlined a conceptual model of
the initial ESRD QIP design and solicited public comments. We received
and reviewed many helpful comments regarding the design of the QIP that
contributed to the development of this proposed rule.
B. Statutory Authority for the ESRD QIP
Congress required in section 153 of MIPPA that the Secretary
implement an ESRD quality incentive program (QIP). We believe that the
QIP is the next step in the evolution of the ESRD quality program
because it measures provider/facility performance rather than simply
reporting outcomes data.
Specifically, section 1881(h) of the Social Security Act (the Act),
as added by section 153(c) of MIPPA, requires the Secretary to develop
a QIP that will result in payment reductions to providers of services
and dialysis facilities that do not meet or exceed a total performance
score with respect to performance standards established for certain
specified measures. As provided under this section, the payment
reductions, which will be up to 2.0 percent of payments otherwise made
to providers and facilities under section 1881(b)(14) of the Act, will
apply to payment for renal dialysis services furnished on or after
January 1, 2012. The total performance score that providers and
facilities must initially meet or exceed in order to receive their full
payment in 2012 will be based on a specific performance period prior to
this date. Under section 1881(h)(1)(C) of the Act, the payment
reduction will only apply with respect to the year involved for a
provider/facility and will not be taken into account when computing
future payment rates for the impacted provider/facility.
For the ESRD quality incentive program, section 1881(h) of the Act
generally requires the Secretary to: (1) Select measures; (2) establish
the performance standards that apply to the individual measures; (3)
specify a performance period with respect to a year; (4) develop a
methodology for assessing the total performance of each provider and
facility based on the performance standards with respect to the
measures for a performance period; and (5) apply an appropriate payment
reduction to providers and facilities that do not meet or exceed the
established total performance score.
We view the ESRD QIP required by section 1881(h) of the Act as the
next step in the evolution of the ESRD quality program that began more
than 30 years ago. Our vision is to implement a robust, comprehensive
ESRD QIP that builds on the foundation that has already been
established.
C. Selection of the ESRD QIP Measures
As required by section 1881(h)(2)(A)(i) of the Act, we finalized
the measures for the initial year of the QIP to include two-anemia
management measures that reflect the labeling approved by the Food and
Drug Administration (FDA) for the administration of erythropoesis
stimulating agents (ESAs), and one-hemodialysis adequacy measure in the
Medicare End-Stage Renal Disease Prospective Payment System Final Rule
(CMS-1418-F) published on August 12, 2010. The following are the three
finalized measures for the initial year of the ESRD QIP:
Percentage of Medicare patients with an average Hemoglobin
<10.0 g/dL
Percentage of Medicare patients with an average Hemoglobin
>12.0 g/dL
Percentage of Medicare patients with an average Urea
Reduction Ratio (URR) 65 percent.
Data for these measures are collected from ESRD claims submitted to
CMS for payment purposes. We have publicly reported anemia and adequacy
of hemodialysis data on DFC since January 2001. The quality measure
selection is limited to these three measures for the first year of the
QIP because they are measures for which we already have complete data
available to us. We are working to develop additional quality measures
that we can adopt for the ESRD QIP in subsequent years.
The ESRD QIP is the first Medicare program that links any provider
or facility payments to performance based on outcomes as assessed
through specific quality measures. The three measures that we adopted
for the initial year of the ESRD QIP are important indicators of
patient outcomes because poor management of anemia and inadequate
dialysis can lead to
[[Page 49218]]
avoidable hospitalizations, decreased quality of life, and death. These
measures are at the core of medical management of ESRD patients.
As noted previously, data for these three measures are collected
through ESRD claims submitted to CMS. The process used to ensure
accuracy of claims coding and measure calculation has been used and
refined since our implementation of the DFC. A full description of the
methodologies used for the calculation of the measures can be reviewed
at: https://www.dialysisreports.org/pdf/esrd/public/DFRGuide.pdf under
the ``Facility Modality, Hemoglobin, and Urea Reduction Ratio''
section.
As we have previously stated, we are committed to adding additional
quality measures as soon as complete data sources become available to
us. For example, we are considering the possibility of adopting
measures such as Kt/V, vascular access rates, bone and mineral
metabolism, and access infection rates to the ESRD QIP for future
years. CMS is committed to further development of quality measures for
future years of the QIP in order to better assess the quality of care
provided by ESRD facilities.
II. Provisions of the Proposed Rule
A. Overview of the Proposed ESRD QIP
This proposed rule proposes to implement a quality incentive
program for Medicare ESRD dialysis providers and facilities with
payment reductions beginning January 1, 2012, in accordance with the
statutory provisions set forth in section 1881(h) of the Act. This
proposed rule was developed based on the conceptual model set forth in
the September 29, 2009 proposed rule (74 FR 49922) and on comments
received on this model. In general, we propose to calculate individual
total performance scores ranging from 0-30 points for providers and
facilities based on the three finalized measures. We propose to weigh
the total performance score for each provider/facility such that the
percentage of Medicare patients with an average Hemoglobin <10 g/dL
measure makes up 50 percent of the score, and the other hemoglobin
measure and the hemodialysis adequacy measure will each be 25 percent
of the score. Providers/facilities that do not meet or exceed a certain
total performance score would receive a payment reduction ranging from
0.5 percent to 2.0 percent. We also propose below how we plan to
implement the public reporting requirements in section 1881(h)(6) of
the Act.
B. Performance Standards for the ESRD QIP Measures
Section 1881(h)(4)(A) of the Act requires the Secretary to
establish performance standards with respect to the measures selected
for the QIP for a performance period with respect to a year. Section
1881(h)(4)(B) of the Act provides that the performance standards shall
include levels of achievement and improvement, as determined
appropriate by the Secretary. However, for the first performance
period, we propose to establish a performance standard for the two
anemia management and one hemodialysis adequacy measures based on the
special rule in section 1881(h)(4)(E) of the Act. This provision
requires the Secretary to ``initially'' use as a performance standard
for the anemia management and hemodialysis adequacy measures the lesser
of a provider/facility-specific performance rate in the year selected
by the Secretary under the second sentence of section
1881(b)(14)(A)(ii) of the Act, or a standard based on the national
performance rate for such measures in a period determined by the
Secretary. We are not proposing to include in this initial performance
standard levels of achievement or improvement because we do not believe
that section 1881(h)(4)(E) of the Act requires that we include such
levels. In addition, we interpret the term ``initially'' to apply only
to the performance period applicable for payment consequence calendar
year 2012. For subsequent performance periods, we plan to propose
performance standards under section 1881(h)(4)(A) of the Act. Such
standards will include levels of achievement and improvement, as
required under section 1881(h)(4)(B) of the Act, and are discussed
below in section III.B QIP Changes and Updates.
As stated above, to implement the special rule for the anemia
management and hemodialysis adequacy measures, we propose to select as
the performance standard the lesser of the performance of a provider or
facility on each measure during 2007 (the year selected by the
Secretary under the second sentence of section 1881(b)(14)(A)(ii) of
the Act, referred to as the base utilization year) or the national
performance rates of all providers/facilities for each measure in 2008.
In terms of establishing a performance standard based on national
performance rates, we propose to adopt a standard that is equal to the
national performance rates of all dialysis providers and facilities
based on 2008 data, as calculated and reported on the Dialysis Facility
Compare Web site. We propose to use 2008 data because it is the most
recent year for which data is publicly available prior to the beginning
of the proposed performance period (discussed below). Specifically, the
rates for the anemia management and hemodialysis adequacy measures were
posted on DFC in November 2009, and are as follows:
For the anemia management measure (referred to in this
proposed rule as ``Hemoglobin Less Than 10 g/dL'')--the national
performance percentage of Medicare patients who have an average
hemoglobin value less than 10.0 g/dL: The national performance rate is
2 percent.
For the anemia management measure (referred to in this
NPRM as ``Hemoglobin More Than 12 g/dL'')--the national performance
percentage of Medicare patients who have an average hemoglobin value
greater than 12.0 g/dL: The national performance rate is 26 percent.
For the proposed hemodialysis adequacy measure (referred
to in this NPRM as ``Hemodialysis Adequacy Measure'')--the percentage
of Medicare patients who have an average URR level above 65 percent:
The national performance rate is 96 percent.
This means that, for the purpose of implementing the special rule
for the anemia management and hemodialysis adequacy measures, we
propose that the performance standard for each of the three measures
for the initial performance period with respect to 2012 payment would
be the lesser of (1) the provider/facility-specific rate for each of
these measures in 2007, or (2) the 2008 national average rates for each
of these measures.
C. Performance Period for the ESRD QIP Measures
Section 1881(h)(4)(D) of the Act requires the Secretary to
establish a performance period with respect to a year, and for that
performance period to occur prior to the beginning of such year.
Because we are required under section 1881(h)(1)(A) of the Act to
implement the payment reduction beginning with renal dialysis services
furnished on or after January 1, 2012, the first performance period
would need to occur prior to that date.
We propose to select all of CY 2010 as the initial performance
period for the three finalized measures. We believe that this is the
performance period that best balances the need to collect sufficient
data, analyze the data, allows us sufficient time to calculate the
provider/facility-specific total performance scores, determine whether
providers and facilities meet the
[[Page 49219]]
performance standards, prepare the pricing files needed to implement
applicable payment reductions beginning on January 1, 2012, and allow
providers and facilities time to preview their performance scores and
inquire about their scores prior to finalizing their scores and making
performance data public (discussed in section II.D. of this proposed
rule). We emphasize that providers/facilities are already required to
submit all the necessary data needed to calculate the measures as part
of their Medicare claims, so this proposal will not create any new
requirements. We seek public comments about the selection of CY 2010 as
the initial performance period.
D. Methodology for Calculating the Total Performance Score for the ESRD
QIP Measures
Section 1881(h)(3)(A)(i) of the Act requires the Secretary to
develop a methodology for assessing the total performance of each
provider and facility based on the performance standards with respect
to the measures selected for a performance period. Section
1881(h)(3)(A)(iii) of the Act states that the methodology must also
include a process to weight the performance scores with respect to
individual measures to reflect priorities for quality improvement, such
as weighting scores to ensure that providers/facilities have strong
incentives to meet or exceed anemia management and dialysis adequacy
performance standards, as determined appropriate by the Secretary. In
addition, section 1881(h)(3)(B) of the Act requires the Secretary to
calculate separate performance scores for each measure. Finally, under
section 1881(h)(3)(A)(ii) of the Act, for those providers and
facilities that do not meet (or exceed) the total performance score,
the Secretary is directed to ensure that the application of the scoring
methodology results in an appropriate distribution of reductions in
payments to providers and facilities, with providers and facilities
achieving the lowest total performance scores receiving the largest
reductions.
We propose to calculate the total performance of each provider and
facility with respect to the measures we have adopted for the initial
performance period by assigning 10 points to each of the three
measures. That is, if a provider or facility meets or exceeds the
performance standard for one measure, then it would receive 10 points
for that measure. We propose to award points on a 0 to 10 point scale
because this scale is commonly used in a variety of settings and we
believe it can be easily understood by stakeholders. We also believe
that the scale provides sufficient variation to show meaningful
differences in performance between providers/facilities.
We propose that a provider or facility that does not meet or exceed
the initial performance standard for a measure based on its 2010 data
would receive fewer than 10 points for that measure, with the exact
number of points corresponding to how far below the initial performance
standard the provider/facility's actual performance falls.
Specifically, we propose to implement a scoring methodology that
subtracts 2 points for every 1 percentage point the provider or
facility's performance falls below the initial performance standard.
For example, if under the special rule, the initial performance
standard for a particular provider or facility for the Hemoglobin More
Than 12 g/dL is set under section 1881(h)(4)(E)(ii) as the 2008
national average rate (26 percent), then if that provider/facility had
28 percent of Medicare patients with hemoglobin levels greater than 12
g/dL during 2010 (the initial performance period), the provider/
facility would receive 6 points for its performance on the measure
because 28 percent is 2 percentage points below the performance
standard (see Table 1, which also illustrates how the scoring would
work if the Hemoglobin Less Than 10 g/dL was set under section
1881(h)(4)(E)(ii) as the 2008 national average rate (2 percent)).
However, if the initial performance standard for the provider/facility
is set under section 1881(h)(4)(E)(i) as the provider or facility's
actual performance during 2007 (for purposes of this example, 30
percent), the provider/facility would receive 10 points for this
measure so long as its performance during 2010 (the initial performance
period) was not worse than 30 percent (see Table 2, which also
illustrates how the scoring would work if the Hemoglobin Less Than 10
g/dL was set under section 1881(h)(4)(E)(i) as the facility's actual
performance during 2007 (for purposes of the example, 4 percent)).
Tables 3 and 4 illustrate how scores would be assigned for the
Hemodialysis Adequacy Measure.
BILLING CODE 4120-01-P
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[[Page 49221]]
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We note that our proposed methodology--that is, subtracting 2
points for every 1 percentage point the provider or facility's
performance falls below the performance standard--does not take into
account the relative variability in performance associated with each
measure. For example, based on 2008 data, a 1 percentage point
difference under the Hemoglobin Less Than 10 g/dL measure would affect
a greater proportion of facilities and providers than a 1 percentage
point difference under the Hemoglobin More Than 12 g/dL measure. The
table below highlights the variability in performance associated with
each measure. (We note that lower scores on the anemia measures reflect
better performance.)
[GRAPHIC] [TIFF OMITTED] TP12AU10.002
[[Page 49222]]
Despite this difference in variability in performance among the
measures, we are proposing to apply the straight-forward methodology we
have described above in a manner that is consistent across all three
measures adopted in this rule. In designing the scoring methodology for
the first year, CMS wanted to adopt a clear-cut approach (that is,
subtracting two points for each percentage point providers and
facilities fell below their performance standard) consistent with the
conceptual model published in the End-Stage Renal Disease Prospective
Payment System Final Rule (CMS-1418-F) on August 12, 2010 in the
Federal Register. We seek public comment on our proposal to apply the
score reductions in this manner, as opposed to a methodology which
takes into account the relative variation in performance that exists
for each measure.
We recognize that this straight-forward approach may not be
appropriate in future years of the QIP as we adopt new measures for
inclusion in the program that may have a wider variability in
performance. Moreover, we may need to reevaluate this approach for the
three measures adopted in this rule, depending on how providers and
facilities perform in future years on these measures. If this approach
is finalized, we will continue to evaluate the applicability and
appropriateness of such an approach in future years of the QIP. As we
have stated, we want to ensure that the performance measures included
in the QIP will result in meaningful quality improvement for patients
at both the national and individual facility/provider level. Therefore,
we seek comment on potential methodologies that would take into account
variation in performance amongst all measures included in the QIP. For
example, under one possible methodology, a provider or facility's
performance could be awarded 10 points for achieving a higher level of
performance (for example, the 90th percentile). The remaining points
could then be assigned according to a linear distribution, where a
provider/facility might receive 0 points for a lower level of
performance (for example, 1 standard deviation below the mean).
In calculating the total performance score, section
1881(h)(3)(A)(iii) of the Act requires the agency to weight the
performance scores with respect to individual measures to reflect
priorities for quality improvement, such as weighting scores to ensure
that providers/facilities have strong incentives to meet or exceed the
performance standards. In the development of our conceptual model, we
initially considered that the initial scoring method would weight each
of the three proposed measures equally. After further examination and
based on the public comments received, we propose to give greater
weight to the Hemoglobin Less Than 10 g/dL measure. Low hemoglobin
levels below 10 g/dL can lead to serious adverse health outcomes for
ESRD patients such as increased hospitalizations, need for
transfusions, and mortality. Giving more weight to the Hemoglobin Less
Than 10 g/dL measure ensures that providers/facilities are incentivized
to continue to properly manage and treat anemia. We believe that this
is important in light of concerns that have been raised that the new
bundled ESRD payment system could improperly incentivize providers/
facilities to undertreat patients with anemia by underutilizing ESAs.
Specifically, we propose to weight the Hemoglobin Less Than 10 g/dL
measure as 50 percent of the total performance score. The remaining 50
percent of the total performance score would be divided equally between
the Hemoglobin More Than 12 g/dL measure and the Hemodialysis Adequacy
Measure. When calculating the total performance score for a provider/
facility, we would first multiply the score achieved by that provider/
facility on each measure (0-10 points) by that measure's assigned
weight (.50 or .25). Then we would add each of the three numbers
together, resulting in a number (although not necessarily an integer)
between 0-10. Lastly, this number would be multiplied by the number of
measures (three) and rounded to the nearest integer (if necessary). In
rounding, any fractional portion 0.5 or greater would be rounded up to
the next integer, while fractional portions less than 0.5 are rounded
down. Thus, a score of 27.4 would round to 27, while 27.6 would round
to 28.
An example of how the proposed scoring methodology would work
follows below. The example assumes that the performance standard for
Facility A during the initial performance period is based on the 2008
national average rates under section 1881(h)(4)(E)(ii) of the Act
(which are set forth above) (because Facility A's base utilization year
results were higher than the 2008 national average) and that Facility A
achieves the following results in 2010:
1. Hemoglobin Less Than 10 g/dL: 2 percent.
2. Hemoglobin More Than 12 g/dL: 26 percent.
3. Hemodialysis Adequacy: 93 percent.
The total performance score for Facility A would be 26 points.
Facility A would receive 10 points for achieving the 2008 national
average rate for the Hemoglobin Less Than 10 g/dL measure (see Table
1); 10 points for achieving the 2008 national average rate for the
Hemoglobin More Than 12 g/dL measure (see Table 1); and 4 points for
performing 3 percentage points below the 2008 national average rate for
the Hemodialysis Adequacy Measure in 2010. Next, we would multiply each
individual measure's score by its assigned weight: 10 x .5 = 5; 10 x
.25 = 2.5; 4 x .25 = 1. Then, all three scores would be added together
and multiplied by three: (5 + 2.5 + 1) x 3 = 25.5. Finally, we would
round Facility A's score to the nearest whole number, resulting in a
total performance score of 26 points (see Table 6 below).
[[Page 49223]]
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It is important to note that this example assumes that Facility A's
facility specific performance in 2007 (the base utilization year) on
each of the three measures was better than or equal to the national
performance average in 2008. If however, Facility A's performance in
2007 on the Hemodialysis Adequacy Measure had been 92 percent, then its
performance standard for that measure would have been set according to
section 1881(h)(4)(E)(i), therefore setting a lower performance
standard for Facility A (see Table 4). In that case, Facility A's score
of 93 percent during the performance period would have earned it a
score of 10 points, resulting in a total performance score of 30 points
(see Table 7 below).
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As we stated above, we believe that this proposed weighting
methodology will ensure that providers/facilities have the incentive to
adequately maintain patients' hemoglobin levels, particularly
considering concerns about appropriate ESA use that could arise when
the new bundled ESRD payment system is implemented. We believe this
proposed weighting methodology is appropriate for the initial year of
the QIP. However, consistent with our desire to improve the quality of
care provided to ESRD patients, we solicit comments on potential
weighting methodologies that could be incorporated to the QIP in future
years as new measures are introduced.
[[Page 49224]]
As previously discussed, we believe this proposed total performance
score methodology is appropriate for the initial performance period in
the new ESRD QIP, but recognize that it will be important to monitor
and potentially reevaluate this methodology as provider and facility
performance changes and as new measures are added in future years of
the ESRD QIP. We seek public comments about the proposed scoring
methodology for the ESRD QIP.
E. Payment Reductions Using the Total Performance Score
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 reductions in payments among providers and
facilities achieving different levels of total performance scores, with
providers and facilities achieving the lowest total performance scores
receiving the largest reductions.
We propose to implement a sliding scale of payment reductions for
payment consequence year 2012, where the minimum total performance
score that providers/facilities would need to achieve in order to avoid
a payment reduction would be 26 points. Providers/facilities that score
between 21-25 points would receive a 0.5 percent payment reduction,
between 16-20 points a 1.0 percent payment reduction, between 11-15
points a 1.5 percent payment reduction, and between 0-10 points the
full 2.0 percent payment reduction (see Table 8). Applying this payment
reduction scale to the example of Facility A above, Facility A's total
performance score of 26 would result in it receiving no payment
reduction.
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In developing the proposed payment reduction scale, we carefully
considered the size of the incentive to providers/facilities to provide
high quality care and range of total performance scores to which the
payment incentive applies, recognizing that this would be the first
year of a new program. Our goal is to avoid situations where small
deficiencies in a provider/facility's performance results in a large
payment reduction. For example, we want to avoid imposing a large
payment reduction on providers/facilities whose performance on one or
more measures falls just slightly below the performance standard. At
the same time, we want poorly performing providers/facilities to
receive a more significant payment reduction. Our analysis suggests
that use of payment differentials of 0.5 percent for the total
performance score ranges we are proposing differentiates between
providers/facilities with fair to good performance and providers/
facilities with poor performance. We will consider smaller
differentials between payment levels for future years of the QIP, which
we believe will further differentiate providers/facilities based on
their performance. Additionally, section 1881(h)(1)(A) of the Act
requires that the Secretary implement payment reductions of up to 2.0
percent, and section 1881(h)(3)(A)(ii) requires that the application of
the total performance score methodology result in an appropriate
distribution of reductions in payment among providers/facilities.
Consistent with these requirements, we believe that Medicare
beneficiaries will be best served if the full 2.0 percent payment
reduction is initially applied only to those providers/facilities whose
performance falls well below the performance standards. We believe that
applying a payment reduction of 2.0 percent to providers/facilities
whose performance falls significantly below the performance standards,
coupled with applying 0.5 payment differential reductions to providers/
facilities based on lesser degrees of performance deficiencies, will
incentivize all providers/facilities to improve the quality of their
care and avoid a payment reduction the following year. We seek public
comments about how the proposed payment reduction scale will
incentivize providers/facilities to meet or exceed the performance
standards for the first year of the QIP, and whether it is an
appropriate standard to use in future years.
In general, ESRD facilities are paid monthly by Medicare for the
ESRD services they furnish to a beneficiary even though payment is on a
per treatment basis. In finalizing the new bundled payment system
starting on January 1, 2011, we elected to continue the practice of
paying ESRD facilities monthly for services furnished to a beneficiary
in the End-Stage Renal Disease Prospective Payment System Final Rule
(CMS-1418-F) published on August 12, 2010.
In keeping with this practice, we propose to apply any payment
reduction under the QIP for payment consequence year 2012 to the
monthly payment amount received by ESRD facilities and providers. The
payment reduction would be applied after any other applicable
adjustments to an ESRD facility's payment, including case-mix, wage
index, outlier, etc, were made. (This includes providers/facilities
being paid a blended amount under the transition and those that had
elected to be excluded from the transition and receive its payment
amount based entirely on the payment amount under the ESRD PPS.)
Section 1833 of the Act governs payments of benefits for Part B
services and the cost sharing amounts for services that are considered
medical and other health services. In general, many Part B services are
subject to a payment structure that requires beneficiaries to be
responsible for a 20 percent co-insurance after the deductible (and
Medicare pays 80 percent). With respect
[[Page 49225]]
to dialysis services furnished by ESRD facilities to individuals with
ESRD, under section 1881(b)(2)(a) of the Act, payment amounts are 80
percent (and 20 percent by the individual).
Under the proposed approach for implementing the QIP payment
reductions, the beneficiary co-insurance amount would be 20 percent of
the total Medicare ESRD payment, after any payment reductions are
applied. To the extent a payment reduction applies, we note that the
beneficiary's co-insurance amount would be calculated after applying
the proposed payment reduction and would thus lower the co-insurance
amount. We seek public comment on the impact of this effect.
We propose to incorporate the statutory requirements of the QIP
payment reduction set forth in proposed Sec. 413.177.
F. Public Reporting Requirements
1. Introduction
Section 1881(h)(6)(A) of the Act requires the Secretary to
establish procedures for making information regarding performance under
the ESRD QIP available to the public, including information on the
total performance score (as well as appropriate comparisons of
providers and facilities to the national average with respect to such
scores) and performance scores for individual measures achieved by each
provider and facility. Section 1881(h)(6)(B) further requires that a
provider or facility has an opportunity to review the information to be
made public with respect to it prior to its publication.
In addition, section 1881(h)(6)(C) of the Act requires the
Secretary to provide each provider and facility with a certificate
containing its total performance score to post in patient areas within
their facility. Finally, section 1881(h)(6)(D) of the Act requires the
Secretary to post a list of providers/facilities and performance-score
data on a CMS-maintained Web site.
2. Notifying Providers/Facilities of Their QIP Scores
Section 1881(h)(6)(B) of the Act requires CMS to establish
procedures that include giving providers/facilities an opportunity to
review the information that is to be made public with respect to the
provider or facility prior to such data being made public.
CMS currently uses a secure, web-based tool to share confidential,
facility-specific quality data with providers, facilities, and select
others. Specifically, we provide annual Dialysis Facility Reports
(DFRs) to dialysis providers/facilities, ESRD Network Organizations,
and State Survey Agencies. The DFRs provide valuable facility-specific
and comparative information on patient characteristics, treatment
patterns, hospitalizations, mortality, and transplantation patterns. In
addition, the DFRs contain actionable practice patterns such as dose of
dialysis, vascular access and anemia management. We expect providers
and facilities to use the data included in the DFRs as part of their
ongoing clinical quality improvement projects.
The information contained in DFRs is sensitive and as such, most of
that information is made available through a secure Web site only to
that provider/facility and its ESRD Network Organization, State Survey
Agency, and the applicable CMS Regional Office. However, select
measures based on DFR data are made available to the public through the
DFC Web site, which allows Medicare beneficiaries and others to review
and compare characteristics and quality information on dialysis
providers and facilities in the United States. To allow dialysis
providers/facilities a chance to ``preview'' these data before they are
released publicly, we supply draft DFRs to providers/facilities in
advance of every annual DFC update. Dialysis providers and facilities
are generally provided 30 days to review their facility-specific data
and submit comments if the provider/facility has any questions or
concerns regarding the report. A provider/facility's comment is
evaluated and researched. If a provider/facility makes us aware of an
error in any DFR information, a recalculation of the quality
measurement results for that provider/facility is conducted, and the
revised results are displayed in the DFC Web site.
We propose to use the above-described procedures, including the
DFRs framework, to allow dialysis providers/facilities to preview their
quality data under the QIP before they are reported publicly.
Specifically, the quality data available for preview through the web
system will include a provider/facility's performance score (both in
total and by individual quality measure) as well as a comparison of how
well the provider/facility's performance scores compare to national
averages for total performance and individual quality measure
performance. We believe that adapting these existing procedures for
purposes of the ESRD QIP will create minimum expense and burden for
providers/facilities because they will not need to familiarize
themselves with a new system or process for obtaining and commenting
upon their preview reports. We also note that under these procedures,
dialysis providers and facilities would have an opportunity to submit
performance score inquiries and to ask questions of CMS data experts
about how their performance scores were calculated on a facility-level
basis. This performance score inquiry process would also give
providers/facilities the opportunity to submit inquiries, including
what they believe to be errors in their performance score calculations,
prior to the public release of the performance scores. Any provider/
facility that submits an inquiry will receive a response.
While we believe that the DFR process is the most logical solution
for meeting the data preview requirement at this time, we may decide to
revise this approach in the future. Should we decide to make changes,
or should we find a more administratively feasible or cost-effective
solution, we propose to use sub-regulatory processes to revise our
approach for administering the QIP performance score preview process in
a way that maintains our compliance with section 1881(h)(6)(B) of the
Act. We also propose to use sub-regulatory processes to determine
issues such as the length of the preview period and the process we will
use to address inquiries received from dialysis providers/facilities
during the preview period.
We seek public comments on our proposal to use the DFR process and
suggestions for other options that will allow dialysis providers/
facilities to preview the information that is to be made public with
respect to the provider or facility in advance of such information
being made public.
3. Informing the Public Through Facility-Posted Certificates
Section 1881(h)(6)(C) of the Act requires the Secretary to provide
certificates to dialysis providers and facilities about their total
performance scores under the QIP. This section also requires each
provider/facility that receives a QIP certificate to display it
prominently in patient areas.
We propose to meet this requirement by providing providers and
facilities with an electronic file in a generally accessible format
(for example, Microsoft Word and/or Adobe Acrobat). We propose to
disseminate these certificates to providers and facilities once per
year after the preview period for the QIP performance scores has been
completed. We would use a secure, web-based system, similar to the
system used to allow facilities to preview their QIP performance
scores, to disseminate certificates. The secure web-based
[[Page 49226]]
system would allow CMS to transmit performance score certificates to
providers/facilities in a secure manner. CMS will make every effort to
synchronize the release of the certificates for provider/facility
display with the release of performance score information on the
Internet.
Under our proposal, each provider/facility would be required to
display the certificate no later than 5 business days after CMS sends
it. We expect that dialysis providers/facilities would have the
capability to download and print their certificates from the secure Web
site. We propose that providers/facilities would be prohibited from
altering the content of the certificates and that they must print the
certificates on plain, blank, white or light-colored paper, no smaller
than 8\1/2\ inches by 11 inches (a standard-sized document). In
addition, providers/facilities may not reduce or otherwise change the
font size on the certificate.
Once printed, we propose that each provider/facility must post at
least one copy of the certificate prominently in a patient area of the
dialysis provider/facility. Specifically, we propose that providers/
facilities must post the certificate in a conspicuous place where they
post other patient-directed materials so that it is in plain view for
all patients (or their parents/guardians or representatives) to
inspect. We will update the certificates annually with new performance
information, and providers/facilities must post the updated certificate
within 5 business days of the day that we transmit it. We expect that
providers/facilities will take steps to prevent certificates from being
altered, defaced, stolen, marred, or covered by other material. In the
event that a certificate is stolen or destroyed while it is posted,
providers/facilities would be responsible for replacing the stolen or
destroyed certificate with a fresh copy by re-printing the certificate
file they have received from CMS. The provider/facility would also be
responsible for answering patient questions about the certificate in an
understandable manner, taking into account that some patients might
have limited English proficiency.
We propose to include on the certificate of each provider/facility
all of the information that we are also making available to the public
under sections 1881(h)(6)(A) and 1881(h)(6)(D) with respect to the
provider/facility. These data elements are:
The total performance score achieved by the provider/
facility under the QIP with respect to the year involved;
Comparative data that shows how well the provider/
facility's total performance score compares to the national total
performance score average;
The performance score that the provider/facility achieved
on each individual measure with respect to the year involved; and
Comparative data that shows how well the provider/
facility's individual quality measure performance scores compare to the
national performance score average for each quality measure.
We considered several options for making QIP performance score data
available via certificates. Regarding the content of the certificates,
we considered including not just information for the ESRD QIP-related
quality measures, but additional quality measure information that CMS
has at its disposal from the DFC Web site that is not related to the
QIP, such as risk-adjusted survival information. Ultimately, we
determined that an electronic method of disseminating certificates was
the easiest way for CMS to deliver certificates directly to providers/
facilities because it is the least burdensome and most cost effective
way of providing the certificates. We also determined that the
information posted on the certificates should be restricted only to QIP
information. We believe that limiting the information on the
certificate to QIP-specific data will make the certificate easier for
Medicare beneficiaries to read and understand.
We seek public comments on how to make the information contained on
the certificate as user friendly and easy to understand as possible,
and how to make the information available to Medicare beneficiaries who
may be unable to read the certificates due to a physical disability or
because of limited or no reading proficiency in the English language.
We are particularly interested in comments on how we can educate
Medicare beneficiaries and their families about the presence of
certificates in dialysis providers/facilities and how the information
can be used to engage in meaningful conversations with their dialysis
caregivers and the clinical community about the quality of America's
kidney dialysis care.
Furthermore, we seek public comments on the proposal to use the DFR
distribution process to provide the certificates to providers/
facilities under section 1881(h)(6)(C) of the Act. Specifically, we
seek comments on the feasibility and advisability of using the DFR
system to provide the certificates to providers/facilities in a
generally available format such as Microsoft Word or Adobe Acrobat.
4. Informing the Public Through Medicare's Web Site
Section 1881(h)(6)(D) of the Act requires the Secretary to use a
CMS-maintained Web site for the purpose of establishing a list of
dialysis providers/facilities that furnish renal dialysis services to
Medicare beneficiaries and that indicates the total performance score
and the performance score for individual measures achieved by the
provider or facility.
We currently use the DFC Web site (a CMS-maintained Web site) to
publish information about the availability of dialysis providers/
facilities across the United States, as well as data about how well
each of these providers/facilities has performed on existing dialysis-
related quality of care measures. DFC is part of a larger suite of
``Compare'' tools, all of which are available online at https://www.medicare.gov. In addition to DFC, CMS hosts Nursing Home Compare,
Home Health Compare, and Hospital Compare, as well as tools that allow
users to compare prescription drug plans, health plans, and Medigap
policies.
DFC links Medicare beneficiaries with detailed information about
each of the over 4,700 dialysis providers/facilities approved by
Medicare, and allows them to compare providers/facilities in a
geographic region. Users can review information about the size of the
provider/facility, the types of dialysis offered, the provider/
facility's ownership, and whether the provider/facility offers evening
treatment shifts. Beneficiaries can also compare dialysis providers/
facilities based on three key quality measures--how well patients at a
provider/facility have their anemia managed, and how well patients at a
provider/facility have waste removed from their blood during dialysis,
and whether the patients treated at a provider/facility generally live
as long as expected. DFC aims to help beneficiaries decide which
dialysis provider/facility would best serve their care needs, as well
as to encourage conversations among beneficiaries and their caregivers
about the quality of care at dialysis providers/facilities, thus
providing an additional incentive for dialysis providers/facilities to
improve the quality of care they furnish. Lastly, DFC links
beneficiaries to resources that support family members, as well as
beneficiary advocacy groups.
Because DFC is a current component of the Medicare suite of Compare
tools, we propose to use DFC as the mechanism for meeting the Web-based
[[Page 49227]]
public information requirement under section 1881(h)(6)(D) of the Act.
DFC is a consumer-focused tool, and the implementation of the QIP will
not change this focus. We recognize that sharing information with the
public about the QIP is not only a statutory requirement: It is also a
function of open and transparent government. Ultimately, the intent of
DFC is to provide beneficiaries with the information they need to be
able to make proper care choices.
We believe that DFC already provides accurate and trusted
information about the characteristics of all Medicare-approved dialysis
providers/facilities, as well as information about the quality of care
furnished by these providers/facilities. Furthermore, CMS already has
the information technology infrastructure in place to support DFC and
its public reporting functions; therefore, adding new QIP-related data
to the DFC Web site would not create additional significant
expenditures or overly burden agency resources.
We propose to update the DFC Web site once per year at a minimum
with the following data elements for every provider/facility listed on
DFC (that is, every Medicare-approved provider/facility):
The total performance score achieved by each provider/
facility under the QIP with respect to the year involved;
Comparative data that shows how well the provider/
facility's total performance score compares to the national total
performance score average;
Scores for each of the individual measures that comprise
the overall QIP performance score for the provider/facility with
respect to the year involved; and
Comparative data that shows how well the provider/
facility's individual quality measure performance scores compare to the
national performance score average for each quality measure.
We note that this is the same information that we are proposing to
include on the certificates that we will provide to providers/
facilities. We seek public comments about whether the total performance
score and the individual measure performance scores should be
integrated into the design of the DFC tool itself or whether we should
alternatively implement section 1881(h)(6)(D) by making a file
availab