Medicare Program; Hospital Inpatient Value-Based Purchasing Program, 2454-2491 [2011-454]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 422 and 480
[CMS–3239–P]
RIN 0938–AQ55
Medicare Program; Hospital Inpatient
Value-Based Purchasing Program
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
In this proposed rule, we are
proposing to implement a Hospital
Value-Based Purchasing program
(‘‘Hospital VBP program’’ or ‘‘the
program’’) under section 1886(o) of the
Social Security Act (‘‘Act’’), under which
value-based incentive payments will be
made in a fiscal year to hospitals that
meet performance standards with
respect to a performance period for the
fiscal year involved. The program will
apply to payments for discharges
occurring on or after October 1, 2012, in
accordance with section 1886(o) of the
Social Security Act (as added by section
3001(a) of the Patient Protection and
Affordable Care Act (Pub. L. 111–148),
enacted on March 23, 2010, as amended
by the Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111–
152), enacted on March 30, 2010
(collectively known as the Affordable
Care Act)). The measures we are
proposing to initially adopt for the
program are a subset of the measures
that we have already adopted for the
existing Medicare Hospital Inpatient
Quality Reporting Program (Hospital
IQR program), formerly known as the
Reporting Hospital Quality Data for the
Annual Payment Update Program
(RHQDAPU), and we are proposing,
based on whether a hospital meets or
exceeds the performance standards that
we are proposing to establish with
respect to the measures, to reward the
hospital based on its actual
performance, rather than simply its
reporting of data for those measures.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on March 8, 2011.
ADDRESSES: In commenting, please refer
to file code CMS–3239–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):
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SUMMARY:
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1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address only:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–3239–
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–3239–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–
8691 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.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Allison Lee, (410) 786–8691.
SUPPLEMENTARY INFORMATION: Inspection
of Public Comments: All comments
received before the close of the
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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. Overview
B. Hospital Inpatient Quality Data
Reporting Under Section 501(b) of Public
Law 108–173
C. Hospital Inpatient Quality Reporting
Under Section 5001(a) of Public Law
109–171
D. 2007 Report to Congress: Plan To
Implement a Medicare Hospital ValueBased Purchasing Program
E. Provisions of the Affordable Care Act
II. Provisions of the Proposed Regulations
A. Overview of the Proposed Hospital
Value-Based Purchasing Program
B. Proposed Performance Period
C. Proposed Measures
D. Proposed Performance Standards
E. Proposed Methodology for Calculating
the Total Performance Score
F. Applicability of the Value-Based
Purchasing Program to Hospitals
G. The Exchange Function
H. Proposed Hospital Notification and
Review Procedures
I. Proposed Reconsideration and Appeal
Procedures
J. Proposed FY 2013 Validation
Requirements for Hospital Value-Based
Purchasing
K. Additional Information
L. QIO Quality Data Access
III. Collection of Information Requirements
IV. Response to Comments
V. Regulatory Impact Statement
A. Overall Impact
B. Anticipated Effects
C. Alternatives Considered
D. Accounting Statement
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:
AHRQ Agency for Healthcare Research and
Quality
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AMI Acute Myocardial Infarction
CCN CMS Certification number
CMS Centers for Medicare & Medicaid
Services
DRG Diagnosis-Related Group
FISMA Federal Information Security and
Management Act
HCAHPS Hospital Consumer Assessment of
Healthcare Providers and Systems
HF Heart Failure
HIPAA Health Insurance Portability and
Accountability Act
HOP QDRP Hospital Outpatient Quality
Data Reporting Program
IPPS Inpatient prospective payment
systems
IQR Inpatient Quality Reporting
NQF National Quality Forum
PN Pneumonia
PQRI Physician Quality Reporting Initiative
PRRB Provider Reimbursement Review
Board
PSI Patient Safety Indicator
QIO Quality Improvement Organization
QRS Quality Review Study
RFA Regulatory Flexibility Act
RHQDAPU Reporting Hospital Quality Data
for the Annual Payment Update Program
RIA Regulatory Impact Analysis
SCIP Surgical Care Improvement
VBP Value-Based Purchasing
I. Background
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A. Overview
The Centers for Medicare & Medicaid
Services (CMS) promotes higher quality
and more efficient health care for
Medicare beneficiaries. In recent years,
we have undertaken a number of
initiatives to lay the foundation for
rewarding health care providers and
suppliers for the quality of care they
provide by tying a portion of their
Medicare payments to their performance
on quality measures. These initiatives,
which include demonstration projects
and quality reporting programs, have
been applied to various health care
settings, including physicians’ offices,
ambulatory care facilities, hospitals,
nursing homes, home health agencies,
and dialysis facilities. The overarching
goal of these initiatives is to transform
Medicare from a passive payer of claims
to an active purchaser of quality health
care for its beneficiaries.
This effort is supported by our
adoption of an increasing number of
widely-agreed upon quality measures
for purposes of our existing quality
reporting programs. We have worked
with stakeholders to define measures of
quality in almost every setting. These
measures assess structural aspects of
care, clinical processes, patient
experiences with care, and,
increasingly, outcomes.
We have implemented quality
measure reporting programs that apply
to various settings of care. With regard
to hospital inpatient services, we
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implemented the Hospital IQR program.
In addition, we have implemented
quality reporting programs for hospital
outpatient services through the Hospital
Outpatient Quality Data Reporting
Program (HOP QDRP), and for
physicians and other eligible
professionals through the Physician
Quality Reporting Initiative (PQRI). We
have also implemented quality reporting
programs for home health agencies and
skilled nursing facilities based on
conditions of participation, and an endstage renal disease quality reporting
program based on conditions for
coverage.
This new program will necessarily be
a fluid model, subject to change as
knowledge, measures and tools evolve.
We view the Hospital VBP program
under section 1886(o) of the Social
Security Act (the Act) as the next step
in promoting higher quality care for
Medicare beneficiaries and transforming
Medicare into an active purchaser of
quality health care for its beneficiaries.
In developing this rule as well as
other value-based payment initiatives,
CMS applied the following principles
for the development and use of
measures and scoring methodologies.
Purpose:
CMS views value-based purchasing as
an important step to revamping how
care and services are paid for, moving
increasingly toward rewarding better
value, outcomes, and innovations
instead of merely volume.
Use of Measures:
• Public reporting and value-based
payment systems should rely on a mix
of standards, process, outcomes, and
patient experience measures, including
measures of care transitions and
changes in patient functional status.
Across all programs, CMS seeks to move
as quickly as possible to the use of
primarily outcome and patient
experience measures. To the extent
practicable and appropriate, outcomes
and patient experience measures should
be adjusted for risk or other appropriate
patient population or provider
characteristics.
• To the extent possible and
recognizing differences in payment
system maturity and statutory
authorities, measures should be aligned
across Medicare’s and Medicaid’s public
reporting and payment systems. CMS
seeks to evolve to a focused core-set of
measures appropriate to the specific
provider category that reflects the level
of care and the most important areas of
service and measures for that provider.
• The collection of information
should minimize the burden on
providers to the extent possible. As part
of that effort, CMS will continuously
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seek to align its measures with the
adoption of meaningful use standards
for health information technology (HIT),
so the collection of performance
information is part of care delivery.
• To the extent practicable, measures
used by CMS should be nationally
endorsed by a multi-stakeholder
organization. Measures should be
aligned with best practices among other
payers and the needs of the end users
of the measures.
Scoring Methodology:
• Providers should be scored on their
overall achievement relative to national
or other appropriate benchmarks. In
addition, scoring methodologies should
consider improvement as an
independent goal.
• Measures or measurement domains
need not be given equal weight, but over
time, scoring methodologies should be
more weighted towards outcome,
patient experience and functional status
measures.
• Scoring methodologies should be
reliable, as straightforward as possible,
and stable over time and enable
consumers, providers, and payers to
make meaningful distinctions among
providers’ performance.
CMS welcomes comments on these
principles.
B. Hospital Inpatient Quality Data
Reporting Under Section 501(b) of
Public Law 108–173
Section 501(b) of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA),
Public Law 108–173, added section
1886(b)(3)(B)(vii) to the Act. This
section established the original
authority for the Hospital IQR program
and revised the mechanism used to
update the standardized payment
amount for inpatient hospital operating
costs. Specifically, section
1886(b)(3)(B)(vii)(I) of the Act provided
for a reduction of 0.4 percentage points
to the annual percentage increase
(sometimes referred to at that time as
the market basket update) for FY 2005
through FY 2007 for a subsection (d)
hospital if the hospital did not submit
data on a set of 10 quality indicators
established by the Secretary as of
November 1, 2003. It also provided that
any reduction applied only to the fiscal
year involved, and would not be taken
into account in computing the
applicable percentage increase for a
subsequent fiscal year. The statute
thereby established an incentive for
many subsection (d) hospitals to submit
data on the quality measures established
by the Secretary.
We implemented section
1886(b)(3)(B)(vii) of the Act in the FY
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2005 IPPS final rule (69 FR 49078) and
codified the applicable percentage
change in § 412.64(d) of our regulations.
We adopted additional requirements
under the Hospital IQR program in the
FY 2006 IPPS final rule (70 FR 47420).
C. Hospital Inpatient Quality Reporting
Under Section 5001(a) of Public Law
109–171
1. Change in the Reduction to the
Annual Percentage Increase
Section 5001(a) of the Deficit
Reduction Act of 2005 (DRA), Public
Law 109–171, further amended section
1886(b)(3)(B) of the Act to, among other
things, revise the mechanism used to
update the standardized payment
amount for hospital inpatient operating
costs by adding new section
1886(b)(3)(B)(viii) to the Act.
Specifically, sections
1886(b)(3)(B)(viii)(I) and (II) of the Act
as added by the DRA originally
provided that the annual percentage
increase for FY 2007 and each
subsequent fiscal year shall be reduced
by 2.0 percentage points for a subsection
(d) hospital that does not submit quality
data in a form and manner, and at a
time, specified by the Secretary. Section
1886(b)(3)(B)(viii)(I) of the Act also
provided that any reduction in a
hospital’s annual percentage increase
will apply only with respect to the fiscal
year involved, and will not be taken into
account for computing the applicable
percentage increase for a subsequent
fiscal year.
In the FY 2007 IPPS final rule (71 FR
48045), we amended our regulations at
§ 412.64(d)(2) to reflect the 2.0
percentage point reduction required
under the DRA.
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2. Selection of Quality Measures
Section 1886(b)(3)(B)(viii)(V) of the
Act, before it was amended by section
3001(a)(2)(B) of the Affordable Care Act,
required that, effective for payments
beginning with FY 2008, the Secretary
add other measures that reflect
consensus among affected parties, and
to the extent feasible and practicable,
have been set forth by one or more
national consensus building entities.
The National Quality Forum (NQF) is a
voluntary consensus standard-setting
organization with a diverse
representation of consumer, purchaser,
provider, academic, clinical, and other
health care stakeholder organizations.
The NQF was established to standardize
health care quality measurement and
reporting through its consensus
development process. We have
generally adopted NQF-endorsed
measures for purposes of the Hospital
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IQR program. However, we believe that
consensus among affected parties also
can be reflected by other means,
including consensus achieved during
the measure development process,
consensus shown through broad
acceptance and use of measures, and
consensus achieved through public
comment.
Section 1886(b)(3)(B)(viii)(VI) of the
Act authorizes the Secretary to replace
any quality measures or indicators in
appropriate cases, such as when all
hospitals are effectively in compliance
with a measure, or the measures or
indicators have been subsequently
shown to not represent the best clinical
practice. We interpreted this provision
to give us broad discretion to replace
measures that are no longer appropriate
for the Hospital IQR program.
We have adopted 45 measures under
the Hospital IQR program for the FY
2011 payment determination. Of these
measures, 27 are chart-abstracted
process of care measures, which assess
the quality of care furnished by
hospitals in connection with four topics:
Acute Myocardial Infarction (AMI);
Heart Failure (HF); Pneumonia (PN);
and Surgical Care Improvement (SCIP)
(75 FR 50182). Fifteen of the measures
are claims-based measures, which assess
the quality of care furnished by
hospitals on the following topics: 30day mortality and 30-day readmission
rates for Medicare patients diagnosed
with either AMI, HF, or PN; Patient
Safety Indicators/Inpatient Quality
Indicators/Composite Measures; and
Patient Safety Indicators/Nursing
Sensitive Care. Three of the measures
are structural measures that assess
hospital participation in cardiac
surgery, stroke care, and nursing
sensitive care systemic databases.
Finally, the Hospital Consumer
Assessment of Healthcare Providers and
Systems (HCAHPS) patient experience
of care survey is included as a measure
for the FY 2011 payment determination.
The technical specifications for the
Hospital IQR program measures, or links
to Web sites hosting technical
specifications, are contained in the
CMS/The Joint Commission
Specifications Manual for National
Hospital Inpatient Quality Measures
(Specifications Manual). This
Specifications Manual is posted on the
CMS QualityNet Web site at https://
www.QualityNet.org/. We maintain the
technical specifications by updating this
Specifications Manual semiannually, or
more frequently in unusual cases, and
include detailed instructions and
calculation algorithms for hospitals to
use when collecting and submitting data
on required measures. These
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semiannual updates are accompanied by
notifications to users, providing
sufficient time between the change and
the effective date in order to allow users
to incorporate changes and updates to
the specifications into data collection
systems.
3. Public Display of Quality Measures
Section 1886(b)(3)(B)(viii)(VII) of the
Act, before it was amended by section
3001(a)(2)(C) of the Affordable Care Act,
required that the Secretary establish
procedures for making data submitted
under the Hospital IQR program
available to the public after ensuring
that a hospital has the opportunity to
review the data before it is made public.
To meet this requirement, we have
displayed most Hospital IQR program
data on the Hospital Compare website,
https://www.hospitalcompare.hhs.gov,
after a 30-day preview period. An
interactive Web tool, this Web site
assists beneficiaries by providing
information on hospital quality of care
to those who need to select a hospital.
It further serves to encourage
beneficiaries to work with their doctors
and hospitals to discuss the quality of
care hospitals provide to patients,
thereby providing an additional
incentive to hospitals to improve the
quality of care that they furnish. The
Hospital Compare website currently
makes public data on clinical process of
care measures, risk adjusted outcome
measures, the HCAHPS patient
experience of care survey, and structural
measures. However, data that we believe
is not suitable for inclusion on Hospital
Compare because it is not salient or will
not be fully understood by beneficiaries,
as well as data for which there are
unresolved display or design issues may
be made available on other CMS Web
sites that are not intended to be used as
an interactive Web tool, such as https://
www.cms.hhs.gov/HospitalQualityInits/.
In such circumstances, affected parties
are notified via CMS listservs, CMS email blasts, national provider calls, and
QualityNet announcements regarding
the release of preview reports followed
by the posting of data on a Web site
other than Hospital Compare.
D. 2007 Report to Congress: Plan To
Implement a Medicare Hospital ValueBased Purchasing Program
Section 5001(b) of the DRA required
the Secretary to develop a plan to
implement a value-based purchasing
program for payments made under the
Medicare program for subsection (d)
hospitals. In developing the plan, we
were required to consider the on-going
development, selection, and
modification process for measures of
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quality and efficiency in hospital
inpatient settings; the reporting,
collection, and validation of quality
data; the structure, size, and sources of
funding of value-based payment
adjustments; and the disclosure of
information on hospital performance.
In 2007, we submitted to Congress a
report that discusses options for a plan
to implement a Medicare hospital VBP
program that builds on the Hospital IQR
program. We recommended replacing
the Hospital IQR program with a new
program that would include both a
public reporting requirement and
financial incentives for better
performance. We also recommended
that a hospital VBP program be
implemented in a manner that would
not increase Medicare spending.
To calculate a hospital’s total
performance score under the plan, we
analyzed a potential performance
scoring model that incorporated
measures from different quality
‘‘domains,’’ including clinical process of
care and patient experience of care. We
examined ways to translate that score
into an incentive payment by making a
portion of the base diagnosis-related
group (DRG) payment contingent on
performance. We analyzed criteria for
selecting performance measures and
considered a potential phased approach
to transition from Hospital IQR to valuebased purchasing. In addition, we
examined redesigning the current data
transmission process and validation
infrastructure, including making
enhancements to the Hospital Compare
Web site, as well as an approach to
monitor the impact of value-based
purchasing.
E. Provisions of the Affordable Care Act
Section 3001(a) of the Patient
Protection and Affordable Care Act
(Pub. L. 111–148), enacted on March 23,
2010, as amended by the Health Care
and Education Reconciliation Act of
2010 (Pub. L. 111–152), enacted on
March 30, 2010 (collectively known as
the Affordable Care Act), added a new
section 1886(o) to the Social Security
Act (the Act) which requires the
Secretary to establish a hospital valuebased purchasing program under which
value-based incentive payments are
made in a fiscal year to hospitals
meeting performance standards
established for a performance period for
such fiscal year. Both the performance
standards and the performance period
for a fiscal year are to be established by
the Secretary. Section 1886(o)(1)(B) of
the Act directs the Secretary to begin
making value-based incentive payments
under the Hospital VBP program to
hospitals for discharges occurring on or
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after October 1, 2012. These incentive
payments will be funded for FY 2013
through a reduction to FY 2013 base
operating DRG payments for each
discharge of 1%, as required by section
1886(o)(7). Section 1886(o)(1)(C)
provides that the Hospital VBP program
applies to subsection (d) hospitals (as
defined in section 1886(d)(1)(B)), but
excludes from the definition of the term
‘‘hospital,’’ with respect to a fiscal year:
1) a hospital that is subject to the
payment reduction under section
1886(b)(3)(B)(viii)(I) for such fiscal year;
2) a hospital for which, during the
performance period for the fiscal year,
the Secretary cited deficiencies that
pose immediate jeopardy to the health
and safety of patients; and 3) a hospital
for which there is not a minimum
number (as determined by the Secretary)
of applicable measures for the
performance period for the fiscal year
involved, or for which there is not a
minimum number (as determined by the
Secretary) of cases for the applicable
measures for the performance period for
such fiscal year.
II. Provisions of the Proposed
Regulations
A. Overview of the Proposed Hospital
VBP Program
This proposed rule proposes to
implement a Hospital Value-Based
Purchasing program (‘‘Hospital VBP
program’’ or ‘‘the program’’) under
section 1886(o) of the Social Security
Act (‘‘Act’’), under which value-based
incentive payments will be made in a
fiscal year (beginning FY 2013) to
hospitals that meet performance
standards established with respect to a
performance period ending prior to the
beginning of such fiscal year. This
proposed rule was developed based on
extensive research we conducted on
hospital value-based purchasing,
including research that formed the basis
of a 2007 report we submitted to
Congress, entitled ‘‘Report to Congress:
Plan to Implement a Medicare Hospital
Value-Based Purchasing Program’’
(November 21, 2007), a copy of which
is available on the CMS Web site, and
takes into account input from both
stakeholders and other interested
parties. As described more fully below,
we are proposing to initially adopt for
the FY 2013 Hospital VBP program 18
measures that we have already adopted
for the Hospital IQR Program,
categorized into two domains, as
follows: 17 of the proposed measures
will be clinical process of care
measures, which we will group into a
clinical process of care domain, and 1
measure will be the HCAHPS survey,
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which will fall under a patient
experience of care domain. With respect
to the clinical process of care and
HCAHPS measures, we are proposing to
use a three-quarter performance period
from July 1, 2011 through March 31,
2012 for the FY 2013 payment
determination and to determine whether
hospitals meet the proposed
performance standards for these
measures by comparing their
performance during the proposed
performance period to their
performance during a proposed threequarter baseline period from July 1,
2009 through March 31, 2010. We are
also proposing to initially adopt for the
FY 2014 Hospital VBP program three
outcome measures. With respect to the
proposed outcome measures, we are
proposing to use an 18-month
performance period from July 1, 2011 to
December 31, 2012. Furthermore, for the
proposed outcome measures, we are
proposing to establish performance
standards and to determine whether
hospitals meet those standards by
comparing their performance during the
proposed performance period to their
performance during a proposed baseline
period of July 1, 2008 to December 31,
2009.
In general, we are proposing to
implement a methodology for assessing
the total performance of each hospital
based on performance standards, under
which we will score each hospital based
on achievement and improvement
ranges for each applicable measure.
Additionally, we are proposing to
calculate a total performance score for
each hospital by combining the greater
of the hospital’s achievement or
improvement points for each measure to
determine a score for each domain,
multiplying each domain score by a
proposed weight (clinical process of
care: 70 percent, patient experience of
care: 30 percent), and adding together
the weighted domain scores. We are
proposing to convert each hospital’s
total performance score into a valuebased incentive payment utilizing a
linear exchange function. All of these
proposals are addressed in greater detail
below.
B. Proposed Performance Period
Section 1886(o)(4) of the Act requires
the Secretary to establish a performance
period for a fiscal year that begins and
ends prior to the beginning of such
fiscal year. In considering various
performance periods that could apply
for purposes of the fiscal year 2013
payment adjustments, we recognized
that hospitals submit data on the chartabstracted measures adopted for the
Hospital IQR Program on a quarterly
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basis, and for that reason, we would
propose that the performance period
commence at the beginning of a quarter.
We also recognize that we must balance
the length of the period for collecting
measure data with the need to
undertake the rulemaking process in
order to establish the performance
period and provide the public with an
opportunity to meaningfully comment
on that proposal. With these
considerations in mind, we concluded
that July 1, 2011 is the earliest date that
the performance period could begin.
We then considered how long the
performance period should be. Our
preference would have been to propose
to use a full year as the performance
period for the clinical process of care
and HCAHPS measures we are
proposing to initially adopt for the FY
2013 Hospital VBP program, consistent
with our analysis that using a full year
performance period provides high levels
of data accuracy and reliability for
scoring hospitals on these measures. We
concluded, however, that this would not
give us sufficient time to calculate the
total performance scores, calculate the
value-based incentive payments, notify
hospitals regarding their payment
adjustments, and implement the
payment adjustments. We subsequently
analyzed how a shorter performance
period might affect a hospital’s
performance score. Using the most
recent clinical process of care and
HCAHPS measure data available, we
examined the feasibility of proposing to
adopt a one quarter, two quarter, or
three quarter performance period by
comparing each of these periods to a
four quarter baseline period. We did this
to determine how closely a hospital’s
total performance score calculated using
one, two, or three quarters of data would
approximate what the hospital’s total
performance score would be if we
proposed to use four quarters of data.
Under our analysis, the total
performance scores approximated using
three quarters of data closely correlated
with total performance scores
approximated using four quarters of
data. Specifically, our analysis showed
that the three quarter performance
period would have a correlation
coefficient of 0.96815 (p-value .0001),
while a two quarter performance period
would have a correlation coefficient of
0.90358 (p-value .0001).
We also recognize that under the
Hospital IQR program, hospitals have
135 days to submit chart abstracted data
following the close of each quarter.
Because we are proposing to implement
a Hospital VBP program that builds on
the Hospital IQR program, we would
like, to the extent possible, to maintain
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our existing Hospital IQR program
requirements. We believe that the 135
day time lag supports the adoption of a
three quarter performance period based
on the analysis discussed above, and
that a one or two quarter performance
period would provide lower data
accuracy for scoring hospitals and
adjusting their payments.
Therefore, we propose to use the
fourth quarter of FY 2011 (July 1, 2011–
September 30, 2011) and the first and
second quarters of FY 2012 (October 1,
2011–March 31, 2012) as the
performance period for proposed
clinical process of care and HCAHPS
measures we are proposing to initially
adopt for the FY 2013 Hospital VBP
program. Hospitals will be scored based
on how well they perform on the
proposed clinical process of care and
HCAHPS measures during this proposed
performance period. We note that we
anticipate proposing to use a full year as
the performance period for the clinical
process of care and HCAHPS measures
in the future. For the three mortality
outcome measures currently specified
for the Hospital IQR program for the FY
2011 payment determination (MORT–
30–AMI, MORT–30–HF, MORT–30–PN)
that we propose below to adopt for the
FY 2014 Hospital VBP program payment
determination, we are proposing to
establish a performance period of July 1,
2011 to December 31, 2012. An
eighteen-month performance period for
mortality measures is intended to
ensure the measures’ reliability by
capturing more cases than could be
observed over one year of measurement.
We plan to add additional measures to
the Hospital VBP program, including
but not limited to AHRQ and HAC
measures that have been specified for
the Hospital IQR program and propose
that the performance period for those
measures will begin one year after these
measures have been displayed on the
Hospital Compare Web site for the
reasons discussed below.
C. Proposed Measures
Section 1886(o)(2)(A) of the Act
requires the Secretary to select for the
Hospital VBP program measures, other
than readmission measures, from the
measures specified for the Hospital IQR
program. Section 1886(o)(2)(B)(i)
requires the Secretary to ensure that the
selected measures include measures on
six specified conditions or topics: Acute
Myocardial Infarction (AMI); Heart
Failure (HF); Pneumonia (PN);
Surgeries, as measured by the Surgical
Care Improvement Project (SCIP);
Healthcare-Associated Infections (HAI);
and, the Hospital Consumer Assessment
of Healthcare Providers and Systems
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survey (HCAHPS). Section
1886(o)(2)(C)(i) provides that the
Secretary may not select a measure with
respect to a performance period for a
fiscal year unless the measure has been
specified under section
1886(b)(3)(B)(viii) of the Act and
included on the Hospital Compare
website for at least one year prior to the
beginning of the performance period.
Section 1886(o)(2)(C)(ii) provides that a
measure selected under section
1886(o)(2)(A) shall not apply to a
hospital if the hospital does not furnish
services appropriate to the measure.
Our measure development and
selection activities for the Hospital IQR
Program take into account national
priorities, such as those established by
the National Priorities Partnership,1 and
the Department of Health and Human
Services,2 as well as other widely
accepted criteria established in medical
literature.3 Because we must select
measures for the Hospital VBP program
from the pool of measures that have
been adopted for the Hospital IQR
program, the measures to be selected for
inclusion in Hospital VBP would also
reflect these priorities.
In the FY 2011 IPPS/RY 2011 LTCH
PPS final rule, we stated that in future
expansions and updates to the Hospital
IQR program measure set, we would be
taking into consideration several
important goals. These goals include: (a)
Expanding the types of measures
beyond process of care measures to
include an increased number of
outcome measures, efficiency measures,
and patients’ experience of care
measures; (b) expanding the scope of
hospital services to which the measures
apply; (c) considering the burden on
hospitals in collecting chart-abstracted
data; (d) harmonizing the measures used
in the Hospital IQR program with other
CMS quality programs to align
incentives and promote coordinated
efforts to improve quality; (e) seeking to
use measures based on alternative
sources of data that do not require chart
abstraction or that utilize data already
being reported by many hospitals, such
as data that hospitals report to clinical
data registries, or all payer claims
databases; and (f) weighing the
relevance and utility of the measures
compared to the burden on hospitals in
submitting data under the Hospital IQR
program. In addition, we believe that we
1 https://www.nationalprioritiespartnership.org/.
2 https://www.hhs.gov/secretary/about/priorities/
priorities.html.
3 Chassin, M.R.; Loeb, J.M.; Schmaltz, S.P. and
Wachter, R.M. (2010) ‘‘Accountability Measures—
Using Measurement to Promote Quality
Improvement.’’ New England Journal of Medicine.
Vol 363: 683–688.
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must act with all speed and
deliberateness to expand the pool of
measures used in the Hospital VBP
program. This goal is supported by at
least two Federal reports documenting
that tens of thousands of patients do not
receive safe care in the nation’s
hospitals.4 For this reason, we believe
that we need to adopt measures for the
Hospital VBP program relevant to
improving care, particularly as these
measures are directed toward improving
patient safety, as quickly as possible.
We believe that speed of
implementation is a critical factor in the
success and effectiveness of this
program.
The Hospital VBP program that we are
proposing to implement has been
developed with the focused intention to
motivate all subsection (d) hospitals to
which the program applies to take
immediate action to improve the quality
of care they furnish to their patients.
Because we view as urgent the necessity
to improve the quality of care furnished
by these hospitals, and because we
believe that hospitalized patients in the
United States currently face patient
safety risks on a daily basis, we are
proposing in this proposed rule to adopt
an initial measure set for the Hospital
VBP program. However, we are also
proposing to add additional measures to
the Hospital VBP program in the future
in such a way that their performance
period will begin immediately after they
are displayed on Hospital Compare for
a period of time of at least one year, but
without the necessity of notice and
comment rulemaking. We propose this
because of the urgency to improve the
quality of hospital care, and in order to
minimize any delay to take substantive
action in favor of patient safety. The
details of this proposal are discussed
below.
We have stated that for the Hospital
IQR Program, we give priority to quality
measures that assess performance on: (a)
Conditions that result in the greatest
mortality and morbidity in the Medicare
population; (b) conditions that are high
volume and high cost for the Medicare
program; and (c) conditions for which
wide cost and treatment variations have
been reported, despite established
clinical guidelines. In addition, we
stated that we seek to select measures
that address the six quality aims of
effective, safe, timely, efficient, patientcentered, and equitable healthcare.
Current and long term priority topics
include: Prevention and population
health; safety; chronic conditions; high
cost and high volume conditions;
elimination of health disparities;
healthcare-associated infections and
other adverse healthcare outcomes;
improved care coordination; improved
efficiency; improved patient and family
experience of care; effective
management of acute and chronic
episodes of care; reduced unwarranted
geographic variation in quality and
efficiency; and adoption and use of
interoperable health information
technology.
We have also stated that these criteria,
priorities, and goals are consistent with
section 1886(b)(3)(B)(viii)(X) of the Act,
as added by section 3001(a)(2)(D) of the
Affordable Care Act, which requires the
Secretary, to the extent practicable and
with input from consensus
organizations and other stakeholders, to
take steps to ensure that the Hospital
IQR program measures are coordinated
and aligned with quality measures
applicable to physicians and other
providers of services and suppliers
under Medicare.
Currently, there are 45 measures
specified under the Hospital IQR
program for the FY 2011 payment
determination. We view all of these
measures (with the exception of the
measures of readmission) as ‘‘candidate
2459
measures’’ for the Hospital VBP
program. We recognize that we cannot
add any measure to the program unless
it meets the requirements of section
1886(o). In determining what measures
to initially propose for the FY 2013
Hospital VBP program we considered
several factors. First, a measure must be
included on the Hospital Compare Web
site for at least one year prior to the
beginning of the performance period
and specified under the Hospital IQR
program. The SCIP–Inf-9 and 10
measures do not meet this requirement
nor do any of the nine (previously ten
given the Nursing Sensitive Care—
Failure to Rescue measure was
harmonized with the Death Among
Surgical Patients with Serious, treatable
Complications) Agency for Healthcare
Research and Quality (AHRQ) measures.
Therefore, these measures were not
considered candidate measures. It is our
intention to add measures to the
Hospital VBP program as soon as this
requirement is met in order to help
improve patient care as quickly as
possible.
As noted above, we recognize that we
cannot include in the measure set any
readmission measures in accordance
with section 1886(o)(2)(A) of the Act.
We also are not proposing at this time
to adopt the current Hospital IQR
structural measures because we believe
that these measures require further
development if they are to be used for
the Hospital VBP program. We seek
public comment at this time on the
possible utility of adopting structural
measures for the Hospital VBP program
measure set and how these measures
might contribute to the improvement of
patient safety and quality of care. Table
1 contains a list of the remaining initial
eligible measures.
TABLE 1—INITIAL ELIGIBLE MEASURES FOR THE FY 2013 HOSPITAL VBP PROGRAM
Measure ID
Measure description
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Process Measures
AMI–1 ..............................................
AMI–2 ..............................................
AMI–3 ..............................................
AMI–4 ..............................................
AMI–5 ..............................................
AMI–7a ............................................
AMI–8a ............................................
HF–1 ...............................................
HF–2 ...............................................
HF–3 ...............................................
HF–4 ...............................................
Aspirin at Arrival.
Aspirin Prescribed at Discharge.
ACE/ARB Inhibitor.
Adult Smoking Cessation Advice/Counseling.
Beta Blocker Prescribed at Discharge.
Fibrinolytic Therapy Received Within 30 Minutes of Hospital Arrival.
Primary PCI Received Within 90 Minutes of Hospital Arrival.
Discharge Instructions.
Evaluation of LVS Function.
ACEI or ARB for LVSD.
Adult Smoking Cessation Advice/Counseling.
4 See OEI–06–09–00090 ‘‘Adverse Events in
Hospitals: National Incidence Among Medicare
Beneficiaries.’’ Department of Health and Human
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Services, Office of Inspector General, November
2010. See also, 2009 National Healthcare Quality
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Report, pp. 107–122. ‘‘Patient Safety,’’ Agency for
Healthcare Research and Quality.
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TABLE 1—INITIAL ELIGIBLE MEASURES FOR THE FY 2013 HOSPITAL VBP PROGRAM—Continued
Measure ID
Measure description
PN–2 ...............................................
PN–3b .............................................
PN–4 ...............................................
PN–5c .............................................
PN–6 ...............................................
PN–7 ...............................................
SCIP–Inf-1 .......................................
SCIP–Inf-2 .......................................
SCIP–Inf-3 .......................................
SCIP–Inf-4 .......................................
SCIP–Inf-6 .......................................
SCIP–Card-2 ...................................
Pneumococcal Vaccination.
Blood Cultures Performed in the Emergency Department Prior to Initial Antibiotic Received in Hospital.
Adult Smoking Cessation Advice/Counseling.
Timing of Receipt of Initial Antibiotic Following Hospital Arrival.
Initial Antibiotic Selection for CAP in Immunocompetent Patient.
Influenza Vaccination.
Prophylactic Antibiotic Received Within One Hour Prior to Surgical Incision.
Prophylactic Antibiotic Selection for Surgical Patients.
Prophylactic Antibiotics Discontinued Within 24 Hours After Surgery End Time.
Cardiac Surgery Patients with Controlled 6AM Postoperative Serum Glucose.
Surgery Patients with Appropriate Hair Removal.
Surgery Patients on a Beta Blocker Prior to Arrival That Received a Beta Blocker During the Perioperative
Period.
Surgery Patients with Recommended Venous Thromboembolism Prophylaxis Ordered.
Surgery Patients Who Received Appropriate Venous Thromboembolism Prophylaxis Within 24 Hours Prior
to Surgery to 24 Hours After Surgery.
SCIP–VTE–1 ...................................
SCIP–VTE–2 ...................................
Outcome Measures
MORT–30–AMI ...............................
MORT–30–HF .................................
MORT–30–PN .................................
Acute Myocardial Infarction (AMI) 30-Day Mortality Rate.
Heart Failure (HF) 30-Day Mortality Rate.
Pneumonia (PN) 30-Day Mortality Rate.
Survey Measures
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HCAHPS .........................................
Hospital Consumer Assessment of Healthcare Providers and Systems Survey.
To determine which measures we
would propose to initially adopt for the
FY 2013 Hospital VBP program, we then
examined whether any of the eligible
Hospital IQR measures (table above)
should be excluded from the Hospital
VBP program measure set because
hospital performance on them is
‘‘topped out,’’ meaning that all but a few
hospitals have achieved a similarly high
level of performance on them. We
believe that measuring hospital
performance on topped-out measures
will have no meaningful effect on a
hospital’s total performance score.
Scoring a topped-out measure for
purposes of the Hospital VBP program
would also present a number of
challenges. First, as we discuss below,
we are proposing that the benchmark
performance standard for all measures
will be the performance at the mean of
the top decile (defined in section II. E.
of this proposed rule). Applied to a
topped-out measure, the benchmark
would be statistically indistinguishable
from the highest attainable score for the
measure and, in our view, could lead to
unintended consequences as hospitals
strive to meet the benchmark. Examples
of unintended consequences could
include, but are not limited to,
inappropriate delivery of a service to
some patients (such as delivery of
antibiotics to patients without a
confirmed diagnosis of pneumonia),
unduly conservative decisions on
whether to exclude some patients from
the measure denominator, and a focus
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on meeting the benchmark at the
expense of actual improvements in
quality or patient outcomes. Second, we
have found that for topped-out
measures, it is significantly more
difficult to differentiate among hospitals
performing above the median. Third,
because a measure cannot be applied to
a hospital unless the hospital furnishes
services appropriate to the measure,
data reporting under the Hospital VBP
program will not be the same for all
hospitals. To the extent that a hospital
can report a higher proportion of
topped-out measures, for which its
scores would likely be high, we believe
that such a hospital would be unfairly
advantaged in the determination of its
total performance score.
To determine whether an eligible
Hospital IQR measure is topped out, we
initially focused on the top distribution
of hospital performance on each
measure and noted if their 75th and
90th percentiles were statistically
indistinguishable. Based on our
analysis, we identified 7 topped-out
measures: AMI–1 Aspirin at Arrival;
AMI–5 Beta Blocker at Discharge; AMI–
3 ACEI or ARB at Discharge; AMI–4
Smoking Cessation; HF–4 Smoking
Cessation; PN–4 Smoking Cessation;
and SCIP–Inf-6 Surgery Patients with
Appropriate Hair Removal. We then
observed that two of these measures
identified as topped out (AMI–3 ACEI or
ARB at Discharge and HF–4 Smoking
Cessation) had significantly lower mean
scores than the others, which led us to
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question whether our analysis was too
focused on the top ends of distributions
and whether additional criteria that
could account for the entire distribution
might be more appropriate. To address
this, we analyzed the truncated
coefficient of variation for each of the
measures. The coefficient of variation
(CV) is a common statistic that
expresses the standard deviation as a
percentage of the sample mean in a way
that is independent of the units of
observation. Applied to this analysis, a
large CV would indicate a broad
distribution of individual hospital
scores, with large and presumably
meaningful differences between
hospitals in relative performance. A
small CV would indicate that the
distribution of individual hospital
scores is clustered tightly around the
mean value, suggesting that it is not
useful to draw distinctions between
individual hospital performance scores.
We used a modified version of the CV,
namely a truncated CV, for each
measure, in which the five percent of
hospitals with the lowest scores, and the
five percent of hospitals with highest
scores were first truncated (set aside)
before calculating the CV. This was
done to avoid undue effects of the
highest and lowest outlier hospitals,
which if included, would tend to greatly
widen the dispersion of the distribution
and make the measure appear to be
more reliable or discerning. For
example, a measure for which most
hospital scores are tightly clustered
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around the mean value (a small CV)
might actually reflect a more robust
dispersion if there were also a number
of hospitals with extreme outlier values,
which would greatly increase the
perceived variance in the measure.
Accordingly, the truncated CV was
added as an additional criterion
requiring that a topped-out measure also
exhibit a truncated CV < 0.10. Using
both the truncated CV and data showing
whether hospital performance at the
75th and 90th percentiles was
statistically indistinguishable, we
reexamined the available measures and
determined that the same seven
measures continue to meet our proposed
definition for being topped-out.
Our priorities for the Hospital VBP
program are to transform how Medicare
pays for care and to encourage hospitals
to continually improve the quality of
care they furnish. Our analysis of the
impact of including the topped-out
measures discussed above shows that
their use would mask true performance
differences among hospitals and, as a
result, would fail to advance these
priorities. Therefore, we are proposing
to not include these 7 topped-out
measures (AMI–1 Aspirin at Arrival;
AMI–5 Beta Blocker at Discharge; AMI–
3 ACEI or ARB at Discharge; AMI–4
Smoking Cessation; HF–4 Smoking
Cessation; PN–4 Smoking Cessation;
and SCIP–Inf-6 Surgery Patients with
Appropriate Hair Removal) in the list of
measures we are proposing to initially
adopt for the FY 2013 Hospital VBP
program.
We examined whether the following
outcome measures adopted for the
Hospital IQR program are appropriate
for inclusion in the FY 2013 Hospital
VBP program. These measures are as
follows: (1) AHRQ patient safety
indicators (PSIs), inpatient quality
indicators (IQIs) and composite
measures; (2) AHRQ PSI and nursing
sensitive care measure; and (3) AMI, HF,
and PN mortality measures (Medicare
patients). We believe that these outcome
measures provide important information
relating to treatment outcomes and
patient safety. We also believe that
adding these outcome measures would
significantly improve the correlation
between patient outcomes and Hospital
VBP performance. However, because
under section 1886(o)(2)(C)(i) of the Act,
we may only select measures if they
have been included on the Hospital
Compare Internet website for a least one
year prior to the beginning of the
performance period, we believe that the
AHRQ Patient Safety Indicators (PSI)
and Inpatient Quality Indicators (IQI)
and composite measures, and the AHRQ
Nursing Sensitive Care measure are not
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yet eligible for inclusion in the FY 2013
Hospital VBP program. These measures
are currently specified for the Hospital
IQR program but have not yet been
included on Hospital Compare. Because
of the urgency to act quickly to improve
patient safety, we plan to adopt them for
use in the Hospital VBP Program as
rapidly as possible and will continue
working to develop additional robust
outcome measures for the Hospital VBP
program. We invite comments on the
addition of the AHRQ PSI, IQI, and
Nursing Sensitive Care measures for
Hospital VBP program inclusion in FY
2014 and future years.
We considered whether the current
publicly-reported 30-day mortality
claims-based measures (Mort–30–AMI,
Mort–30–HF, Mort–30–PN) should be
included in the FY 2013 Hospital VBP
program. The mortality measures assess
hospital-specific, risk-standardized, allcause 30-day mortality rates for patients
hospitalized with a principal diagnosis
of heart attack, heart failure, and
pneumonia. All-cause mortality is
defined for purposes of these measures
as death from any cause within 30 days
after the index admission date,
regardless of whether the patient died
while still in the hospital or after
discharge. On July 1, 2009, the
specifications for these measures were
changed from a one-year reporting
period to a three-year rolling average.
This was done to address concerns
regarding the reliability of the measures,
and the three-year rolling average allows
us to include a larger number of cases
in the measure calculations, although
our analysis shows that eighteen months
of these data is also reliable. We do not
believe that the three-quarter
performance period we are proposing to
use for the initial clinical process of care
and HCAHPS measures for the FY 2013
Hospital VBP program would be
appropriate to use for these mortality
outcome measures because we do not
believe that the data collected for these
mortality measures during those three
quarters will provide us with
sufficiently accurate information about a
hospital’s outcomes on which to score
hospitals on these measures and base
payment. The detailed methodology for
the 30-day risk standardized mortality
measures is available on https://
www.qualitynet.org.
However, we propose to adopt these
currently reported 30-day mortality
claims-based measures (MORT–30–
AMI, MORT–30–HF, and MORT–30–
PN) as measures for the FY 2014
Hospital VBP program and, as proposed
above, to establish a performance period
with respect to these measures of July 1,
2011 to December 31, 2012.
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The eligible clinical process of care
measures that have not been excluded
for reasons previously discussed cover
acute myocardial infarction, heart
failure, pneumonia, and surgeries (as
measured by the Surgical Care
Improvement Project (SCIP)). Therefore,
we believe that they meet the
requirements in section
1886(o)(2)(B)(i)(I)(aa)–(dd) of the Act.
Section 1886(o)(2)(B)(i)(ee) of the Act
requires the Secretary to also select for
purposes of the FY 2013 Hospital VBP
program measures that cover healthcareassociated infections (HAI) ‘‘as
measured by the prevention metrics and
targets established in the HHS Action
Plan to Prevent Healthcare-Associated
Infections (or any successor plan) of the
Department of Health and Human
Services.’’ The SCIP measures that we
discuss above were developed to
support practices that have
demonstrated an ability to significantly
reduce surgical complications such as
HAIs. Compliance with these SCIP
infection measures is also included as a
targeted metric in the HHS Action Plan
to Prevent Healthcare-Associated
Infections issued in 2009, available on
the HHS website. As a result, we believe
that the SCIP–Inf-1; SCIP–Inf-2; SCIP–
Inf-3; and SCIP–Inf-4 measures we have
adopted for the Hospital IQR program
meet the requirement in section
1886(o)(2)(B)(i)(I)(ee) and we propose to
categorize them under a HAI condition
topic instead of under the SCIP
condition topic.
Under section 1886(o)(2)(B)(i)(II), the
Secretary must select measures for the
FY 2013 Hospital VBP program related
to the Hospital Consumer Assessment of
Healthcare Providers and Systems
survey (HCAHPS). CMS partnered with
the Agency for Healthcare Research and
Quality (AHRQ) to develop HCAHPS.
The HCAHPS survey is the first
national, standardized, publicly
reported survey of patients’ experiences
of hospital care, and we propose to
adopt it for the FY 2013 Hospital VBP
program. HCAHPS, also known as the
CAHPS® Hospital Survey, is a survey
instrument and data collection
methodology for measuring patients’
perceptions of their hospital experience.
The HCAHPS survey asks discharged
patients 27 questions about their recent
hospital stay that are used to measure
the experience of patients across 10
dimensions in the Hospital IQR
program. The survey contains 18 core
questions about critical aspects of
patients’ hospital experiences
(communication with nurses and
doctors, the responsiveness of hospital
staff, the cleanliness and quietness of
the hospital environment, pain
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management, communication about
medicines, discharge information,
overall rating of the hospital, and
whether they would recommend the
hospital). The survey also includes four
items to direct patients to relevant
questions if a patient did not have a
particular experience covered by the
survey, such as taking new medications
or needing medicine for pain. Three
items in the survey are used to adjust for
the mix of patients across hospitals, and
two items related to race and ethnicity
support congressionally-mandated
reports on disparities in health care.
The HCAHPS survey is administered
to a random sample of adult patients
across medical conditions between 48
hours and six weeks after discharge; the
survey is not restricted to Medicare
beneficiaries. Hospitals must survey
patients throughout each month of the
year. The survey is available in official
English, Spanish, Chinese, Russian and
Vietnamese versions. The survey and its
protocols for sampling, data collection
and coding, and file submission can be
found in the HCAHPS Quality
Assurance Guidelines, Version 5.0,
which is available on the official
HCAHPS website, https://
www.hcahpsonline.org.
AHRQ carried out a rigorous,
scientific process to develop and test the
HCAHPS instrument. This process
entailed multiple steps, including: A
public call for measures; literature
review; cognitive interviews; consumer
focus groups; stakeholder input; a threestate pilot test; small-scale field tests;
and soliciting public comments via
several Federal Register notices. In May
2005, the HCAHPS survey was endorsed
by the National Quality Forum (NQF).
CMS adopted the entire HCAHPS
survey as a measure in the Hospital IQR
program in October 2006, and the first
public reporting of HCAHPS results
occurred in March 2008. The survey, its
methodology and the results it produces
are available on the HCAPHS website at
https://www.hcahpsonline.org/
home.aspx. With respect to our display
of the HCAHPS measure on Hospital
Compare for purposes of the Hospital
IQR program, we publicly report the
measure as 10 separate items. The
‘‘cleanliness of hospital environment,’’
‘‘quietness of hospital environment,’’
‘‘overall rating of the hospital,’’ and
‘‘recommend the hospital’’ survey items
are displayed as stand-alone items. The
remaining 6 items (communication with
nurses, communication with doctors,
responsiveness of hospital staff, pain
management, communication about
medicines, discharge information) are
composites of the remaining survey
items.
Finally, we propose to not include the
PN–5c measure in the Hospital VBP
program. We do not believe that this
measure is appropriate for inclusion
because it could lead to inappropriate
antibiotic use. We intend to propose to
retire this measure, as well as several
other measures that we are not
proposing to adopt for the Hospital VBP
program, from the Hospital IQR program
in the near future.
Accordingly, we propose to initially
select the following 17 clinical process
of care measures, and the HCAHPS
measure, for inclusion in the FY 2013
Hospital VBP program. The proposed
list of initial measures is provided in
Table 2.
TABLE 2—PROPOSED INITIAL MEASURES FOR FY 2013 HOSPITAL VBP PROGRAM
Measure ID
Measure description
Clinical Process of Care Measures
Acute myocardial infarction:
AMI–2 .................................................................................
AMI–7a ...............................................................................
AMI–8a ...............................................................................
Heart Failure:
HF–1 ...................................................................................
HF–2 ...................................................................................
HF–3 ...................................................................................
Pneumonia:
PN–2 ..................................................................................
PN–3b ................................................................................
PN–6 ..................................................................................
PN–7 ..................................................................................
Healthcare-associated infections:
SCIP–Inf-1 ..........................................................................
SCIP–Inf-2 ..........................................................................
SCIP–Inf-3 ..........................................................................
SCIP–Inf-4 ..........................................................................
Surgeries:
SCIP–Card-2 ......................................................................
SCIP–VTE–1 ......................................................................
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SCIP–VTE–2 ......................................................................
Aspirin Prescribed at Discharge.
Fibrinolytic Therapy Received Within 30 Minutes of Hospital Arrival.
Primary PCI Received Within 90 Minutes of Hospital Arrival.
Discharge Instructions.
Evaluation of LVS Function.
ACEI or ARB for LVSD.
Pneumococcal Vaccination.
Blood Cultures Performed in the Emergency Department Prior to Initial Antibiotic Received in Hospital.
Initial Antibiotic Selection for CAP in Immunocompetent Patient.
Influenza Vaccination.
Prophylactic Antibiotic Received Within One Hour Prior to Surgical Incision.
Prophylactic Antibiotic Selection for Surgical Patients.
Prophylactic Antibiotics Discontinued Within 24 Hours After Surgery End Time.
Cardiac Surgery Patients with Controlled 6AM Postoperative Serum Glucose.
Surgery Patients on a Beta Blocker Prior to Arrival That Received a Beta Blocker
During the Perioperative Period.
Surgery Patients with Recommended Venous Thromboembolism Prophylaxis Ordered.
Surgery Patients Who Received Appropriate Venous Thromboembolism Prophylaxis
Within 24 Hours Prior to Surgery to 24 Hours After Surgery.
Survey Measures
HCAHPS ............................................................................
5 Proposed dimensions of the
HCAHPS survey for use in the FY 2013
Hospital VBP program include:
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Communication with Nurses,
Communication with Doctors,
Responsiveness of Hospital Staff, Pain
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Management, Communication about
Medicines, Cleanliness and Quietness of
Hospital Environment, Discharge
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Information and Overall Rating of
Hospital.
We solicit public comments on these
proposed measures and also on our
intention to add additional measures to
the Hospital VBP Program as rapidly as
possible going forward. To that end, we
are proposing to implement a
subregulatory process to expedite the
timeline for adding measures to the
Hospital VBP program beginning with
the FY 2013 program. Under this
process we could add any measure to
the Hospital VBP program if that
measure is adopted under the Hospital
IQR program and has been included on
the Hospital Compare Web site for at
least one year. We are proposing that the
performance period for all of these
measures would start exactly one year
after the date these measures are
publicly posted on Hospital Compare,
consistent with section 1886(o)(2)(C)(i).
Under this proposed subregulatory
process, we would solicit comments
from the public on the appropriateness
of adopting one or more Hospital IQR
measures for the Hospital VBP program.
We would also assess the Hospital IQR
measure rates using the criteria we used
to select the proposed measures for the
initial FY 2013 Hospital VBP measure
set and notify the public regarding our
findings. We would propose
performance period end dates for any
measure we selected for Hospital VBP
program in rulemaking. We are also
proposing to implement a subregulatory
process to retire Hospital VBP measures.
Under this process, we would post our
intention to retire measures on the CMS
Web site at least 60 days prior to the
date that we will retire the measure. We
would also, as we do with respect to
Hospital IQR measures that we believe
pose immediate patient safety concerns
if reporting on them is continued, notify
hospitals and the public of the
retirement of the measure and the
reasons for its retirement through the
usual hospital and QIO communication
channels used for the Hospital IQR
program, which include e-mail blasts to
hospitals and the dissemination of
Standard Data Processing System
(SDPS) memoranda to QIOs, as well as
posting the information on the
QualityNet Web site. We would then
confirm the retirement of the measure
from the Hospital VBP program measure
set in a rulemaking vehicle. We make
this proposal because it will allow us to
ensure that the Hospital VBP program
measure set focuses on the most current
quality improvement and patient safety
priorities. We are seeking public
comment on our proposals and other
methods that allow for the addition of
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measures to the Hospital VBP program
as rapidly as possible in order to
improve quality and safety for patients.
For value-based incentive payments
made with respect to discharges
occurring during FY 2014 or a
subsequent fiscal year, CMS is required
by statute to ensure that the measures
selected for the Hospital VBP program
include efficiency measures, including
measures of ‘‘Medicare Spending per
beneficiary.’’ CMS solicits public
comment as to what services should be
included and what should be excluded
in a ‘‘Medicare spending per
beneficiary’’ calculation. For example,
the calculation could include outlier
payments and/or Part B payments for
services furnished during an inpatient
hospital stay, or could include Part A
and Part B payments for services
received by a beneficiary during some
window of time prior to the admission
and/or after the discharge. We also
solicit public comment on what, if any,
type(s) of hospital segmentation or
adjustment should be considered.
In addition, we are considering
different approaches for measuring
internal hospital efficiency. Internal
hospital efficiency measures could
assess hospital spending per admission,
as determined using cost reports or
other sources. CMS seeks comment on
this and other approaches for measuring
internal hospital efficiency.
D. Proposed Performance Standards
Section 1886(o)(3)(A) requires the
Secretary to establish performance
standards with respect to the measures
selected under the Hospital VBP
program for a performance period for a
fiscal year. The performance standards
must include levels of achievement and
improvement (section 1886(o)(3)(B)),
and must be established and announced
not later than 60 days prior to the
beginning of the performance period for
the fiscal year involved (section
1886(o)(3)(C)). Achievement and
improvement levels are discussed more
fully in section II. E. of this proposed
rule. In addition, as part of the process
for establishing the performance
standards, the Secretary must take into
account appropriate factors, such as: (1)
Practical experience with the measures,
including whether a significant
proportion of hospitals failed to meet
the performance standard during
previous performance periods; (2)
historical performance standards; (3)
improvement rates; and (4) the
opportunity for continued improvement
(section 1886(o)(3)(D)).
To determine what the proposed
performance standard for each proposed
clinical process of care measure and the
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proposed HCAHPS measure should be
for purposes of the FY 2013 Hospital
VBP program, we analyzed the most
reliable and current hospital data that
we have on each of these measures by
virtue of the Hospital IQR program.
Because we are proposing to adopt a
performance period that is less than a
full year for FY 2013, we were also
sensitive to the fact that hospital
performance on the proposed measures
may be affected by seasonal variations
in patient mix, case severity, and other
factors.
To address this potential variation
and ensure that the hospital scores
reflect their actual performance on the
measures, we believe that the
performance standard for each clinical
process of care measure and HCAHPS
should be based on how well hospitals
performed on the measure during the
same three quarters in a baseline period.
In determining what three-quarter
baseline period would be the most
appropriate to propose to use for the FY
2013 Hospital VBP program, we wanted
to ensure that the baseline would be as
close in time to the proposed
performance period as possible. We
believe that selecting a three-quarter
baseline period from July 1, 2009 to
March 31, 2010 will enable us to
achieve this goal. Although the
proposed baseline period has ended, we
are still in the process of validating this
data and expect the validation process
to be complete by the end of January
2011.
We also believe that an essential goal
of the Hospital VBP program is to
provide incentives to all hospitals to
improve the quality of care that they
furnish to their patients. In determining
what level of hospital performance
would be appropriate to select as the
performance standards for each
measure, we focused on selecting levels
that would challenge hospitals to
continuously improve or maintain high
levels of performance. As required by
Section 1886(o)(3)(D), we specifically
considered hospitals’ practical
experience with the measures,
particularly through the Hospital IQR
program, examining how different
achievement and improvement
thresholds would have historically
impacted hospitals, how hospital
performance may have changed over
time, and how hospitals could continue
to improve. For these reasons, we
propose to set the achievement
performance standard (achievement
threshold) for each proposed measure at
the median of hospital performance
(50th percentile) during the baseline
period of July 1, 2009 through March 31,
2010. As proposed in section II. E. of
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this proposed rule, hospitals would
receive achievement points only if they
exceed the achievement performance
standard and could increase their
achievement score based on higher
levels of performance. We believe these
achievement performance standards
represent achievable standards of
excellence. We also propose to set the
improvement performance standard
(improvement threshold) for each
proposed measure at each specific
hospital’s performance on the measure
during the proposed baseline period of
July 1, 2009 through March 31, 2010.
We believe that these improvement
performance standards ensure that
hospitals will be adequately
incentivized to improve.
Because our process for validating the
proposed baseline period of data is not
yet complete, we are unable to provide
the precise achievement threshold
values for what these performance
standards will be at this time. These
values will be specified in the final rule.
We specify example achievement
performance standards, using July 1,
2008 through March 31, 2009 data, in
Table 3 below.
TABLE 3—EXAMPLE ACHIEVEMENT PERFORMANCE STANDARDS FOR FY 2013 HOSPITAL VBP PROPOSED MEASURES
Measure ID
Example
performance
standard
Measure description
Process Measures
AMI–2 ......................................................
AMI–7a ....................................................
AMI–8a ....................................................
HF–1 ........................................................
HF–2 ........................................................
HF–3 ........................................................
PN–2 ........................................................
PN–3b ......................................................
PN–6 ........................................................
PN–7 ........................................................
SCIP–Inf-1 ...............................................
SCIP–Inf-2 ...............................................
SCIP–Inf-3 ...............................................
SCIP–Inf-4 ...............................................
SCIP–VTE–1 ...........................................
SCIP–VTE–2 ...........................................
Aspirin Prescribed at Discharge ................................................................................
Fibrinolytic Therapy Received Within 30 Minutes of Hospital Arrival .......................
Primary PCI Received Within 90 Minutes of Hospital Arrival ...................................
Discharge Instructions ...............................................................................................
Evaluation of LVS Function .......................................................................................
ACEI or ARB for LVSD .............................................................................................
Pneumococcal Vaccination .......................................................................................
Blood Cultures Performed in the Emergency Department Prior to Initial Antibiotic
Received in Hospital.
Initial Antibiotic Selection for CAP in Immunocompetent Patient .............................
Influenza Vaccination ................................................................................................
Prophylactic Antibiotic Received Within One Hour Prior to Surgical Incision ..........
Prophylactic Antibiotic Selection for Surgical Patients ..............................................
Prophylactic Antibiotics Discontinued Within 24 Hours After Surgery End Time .....
Cardiac Surgery Patients with Controlled 6AM Postoperative Serum Glucose .......
Surgery Patients with Recommended Venous Thromboembolism Prophylaxis Ordered.
Surgery Patients Who Received Appropriate Venous Thromboembolism Prophylaxis Within 24 Hours Prior to Surgery to 24 Hours After Surgery.
0.987
0.673
0.856
0.872
0.983
0.944
0.929
0.951
0.909
0.909
0.955
0.978
0.927
0.912
0.938
0.913
Survey Measures
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HCAHPS ..................................................
Hospital Consumer Assessment of Healthcare Providers and Systems Survey .....
• Communication with Nurses ..................................................................................
• Communication with Doctors .................................................................................
• Responsiveness of Hospital Staff ..........................................................................
• Pain Management ..................................................................................................
• Communication About Medicines ..........................................................................
• Cleanliness and Quietness of Hospital Environment ............................................
• Discharge Information ............................................................................................
• Overall Rating of Hospital ......................................................................................
We also propose to use an 18-month
performance period of July 1, 2011 to
December 31, 2012, with a baseline
period of July 1, 2008 to December 31,
2009, for the mortality measures
(MORT–30–AMI, MORT–30–HF,
MORT–30–PN) we are proposing to
initially include in the FY 2014 Hospital
VBP program. Like the proposed clinical
process of care and HCAHPS measures,
we propose to set the achievement
performance standard (achievement
threshold) for each proposed outcome
measure at the median of hospital
performance (50th percentile) during
the proposed baseline period. Similarly,
we propose to set the improvement
performance standard (improvement
threshold) for each proposed outcome
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measure at each specific hospital’s
performance on each measure during
the proposed baseline period of July 1,
2008 to December 31, 2009. We provide
the following sample achievement
thresholds, (displayed as survival rates)
derived from July 2006–July 2009 as
examples of the achievement
performance standards for that period:
• MORT–30–AMI: 83.7%
• MORT–30–HF: 88.8%
• MORT–30–PN: 88.5%.
We solicit public comments on the
proposed performance standards as
described above.
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E. Proposed Methodology for
Calculating the Total Performance Score
1. Statutory Provisions—Proposed
Methodology for Calculating the Total
Performance Score
Section 1886(o)(5)(A) of the Act
requires the Secretary to develop a
methodology for assessing each
hospital’s total performance based on
performance standards with respect to
the measures selected for a performance
period. Using such methodology, the
Secretary must provide for an
assessment for each hospital for each
performance period. Section
1886(o)(5)(B) of the Act sets forth four
additional requirements related to the
scoring methodology developed by the
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Secretary under section 1886(o)(5)(A).
Specifically, section 1886(o)(5)(B)(i)
requires the Secretary to ensure that the
application of the scoring methodology
results in an appropriate distribution of
value-based incentive payments among
hospitals receiving different levels of
hospital performance scores, with
hospitals achieving the highest hospital
performance scores receiving the largest
value-based incentive payments.
Section 1886(o)(5)(B)(ii) provides that
under the methodology, the hospital
performance score must be determined
using the higher of its achievement or
improvement score for each measure.
Section 1886(o)(5)(B)(iii) requires that
the hospital scoring methodology
provide for the assignment of weights
for categories of measures as the
Secretary deems appropriate. Section
1886(o)(5)(B)(iv) prohibits the Secretary
from setting a minimum performance
standard in determining the hospital
performance score for any hospital.
Finally, section 1886(o)(5)(B)(v) requires
that the hospital performance score for
a hospital reflect the measures that
apply to the hospital.
2. Additional Factors for
Consideration—Proposed Methodology
for Calculating the Total Performance
Score
In addition to statutory requirements,
we also considered several additional
factors when developing the proposed
performance scoring methodology for
the Hospital Value-Based Purchasing
program. First, we believe it is
important that the performance scoring
methodology is straight forward and
transparent to hospitals, patients, and
other stakeholders. Hospitals must be
able to clearly understand performance
scoring methods and performance
expectations to maximize quality
improvement efforts. The public must
understand performance score methods
to utilize publicly reported information
when choosing hospitals. Second, we
believe the scoring methodologies for all
Medicare Value-Based Purchasing
programs, including (but not limited to)
the End Stage Renal Disease Quality
Incentive Program (42 CFR Part 413)
should be aligned as appropriate given
their specific statutory requirements.
This alignment will facilitate the
public’s understanding of quality
information disseminated in these
programs and foster more informed
consumer decision making about health
care. Third, we believe differences in
performance scores must reflect true
differences in performance. In order to
ensure this in the proposed Hospital
Value-Based Purchasing Program, we
assessed the quantitative characteristics
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of the measures we are proposing to use
to calculate a performance score,
including the current state of measure
development, distribution of current
hospital performance in the proposed
measure set, number of measures, and
the number and grouping of measure
domains. Fourth, we must appropriately
measure both quality achievement and
improvement in our Hospital ValueBased Purchasing program. Section
1886(o)(5)(B)(ii) of the Act specifies that
performance scores under the Hospital
Value-Based Purchasing program be
calculated utilizing the higher of
achievement and improvement scores
for each measure, and that explicit
direction has implications for the design
of the performance scoring
methodology. We must also consider the
impact of performance scores utilizing
achievement and improvement on
hospital behavior due to payment
implications. Fifth, we wish to
eliminate unintended consequences for
rewarding inappropriate hospital
behavior and outcomes to patients in
our performance scoring methodology.
Sixth, we wish to utilize the most
currently available data to assess
hospital improvement in a performance
score methodology. We believe that
more current data would result in a
more accurate performance score, but
recognize that hospitals require time to
abstract and collect quality information.
We also require time to process this
information accurately.
This proposed rule’s method for
calculating the improvement score relies
on a comparison of the current payment
year’s performance period with a
‘‘baseline’’ period of July 1, 2008 through
December 31, 2009 for the three 30-day
mortality measures, rather than a
comparison of the current year with the
previous year (as outlined in the 2007
report to Congress). We propose this
baseline period because these data are
the most currently available data at this
time for public comment. We plan to
propose future annual updates to the
baseline period through future
rulemaking. We recognize that
comparing a payment year’s
performance period with the previous
year’s performance period may be a
better estimate of incremental
improvement. As noted above, we
solicit comment on the merits and
impact of all of the factors related to our
performance score methodology
alternatives, including the choice of
how to define the baseline year.
We solicit comment on the merits and
impact of all of these factors related to
our performance score methodology
alternatives described in the next
section of this proposed rule.
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Specifically, we welcome suggestions
on improving the simplicity of the
Hospital Value-Based Purchasing
program performance score
methodology and its alignment with
other CMS Value-Based Purchasing
programs. We recognize that statutorily
mandated differences may require
differences in performance score
methodologies among the CMS ValueBased Purchasing programs.
3. Background—Proposed FY 2013
Hospital VBP Program Scoring
Methodology
In November 2007, CMS published a
report entitled, ‘‘Report to Congress:
Plan to Implement a Medicare Hospital
Value-Based Purchasing Program’’
(referred to in this proposed rule as the
‘‘2007 Report to Congress’’).6 In addition
to laying the groundwork for hospital
value-based purchasing, the 2007 Report
to Congress analyzed and presented a
potential performance scoring
methodology (called the Performance
Assessment Model) for the Hospital VBP
program. The Performance Assessment
Model combines scores on individual
measures across different quality
categories or ‘‘domains’’ (for example,
clinical process of care, patient
experience of care) to calculate a
hospital’s total performance score. The
Performance Assessment Model
provides a methodology for evaluating a
hospital’s performance on each quality
measure based on the higher of an
attainment score in the measurement
period or an improvement score, which
is determined by comparing the
hospital’s current measure score with a
baseline period of performance. The use
of an improvement score is intended to
provide an incentive for a broad range
of hospitals that participate in a hospital
VBP program by awarding points for
showing improvement on quality
measures, not solely for outperforming
other hospitals.
Under the Performance Assessment
Model, measures are grouped into
domains, for example, clinical process
of care (which could include AMI, HF,
PN, and SCIP) and patient experience of
care (for example, HCAHPS). A score is
calculated for each domain by
combining the measure scores within
that domain, weighting each measure
equally. The domain score reflects the
percentage of points earned out of the
total possible points for which a
hospital is eligible. A hospital’s total
performance score is determined by
aggregating the scores across all
6 The report may be found at https://www.cms.gov/
AcuteInpatientPPS/downloads/
HospitalVBPPlanRTCFINALSUBMITTED2007.pdf.
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domains. In aggregating the scores
across domains, the domains could be
weighted equally or unequally,
depending on the policy goals. The total
performance score is then translated
into the percentage of Hospital VBP
incentive payment earned using an
exchange function, which aligns
payments with desired policy goals.
process of care, patient experience of
care, and outcomes), weighting the
domains, and calculating the hospital
total performance score. In the
discussion, we highlight any differences
between the Three-Domain Performance
Scoring Model and the Performance
Assessment Model, along with our
reasons for the departure.
4. Proposed FY 2013 Hospital VBP
Program Scoring Methodology
We believe that the Performance
Assessment Model presented and
analyzed in the 2007 Report to Congress
provides a useful foundation for
developing a FY 2013 Hospital VBP
program performance scoring
methodology that comports with the
requirements in section 1886(o) of the
Act. The Performance Assessment
Model outlines an approach that we
believe is well-understood by patient
advocates, hospitals and other
stakeholders, was developed during a
year-long process that involved
extensive stakeholder input, and was
presented by us to Congress. Since
issuing the report, we have conducted
further, extensive research on a number
of important methodology issues for the
Hospital VBP program, including the
impact of topped-out measures on
scoring, appropriate case minimum
thresholds for measures, appropriate
measure minimum thresholds per
domain, and other issues required to
ensure a high level of confidence in the
scoring methodology (all of which we
discuss in this proposed rule).
After carefully reviewing and
evaluating a number of potential
performance scoring methodologies for
the Hospital VBP program, we propose
to use a Three-Domain Performance
Scoring Model, although only two
domains will receive weight in FY 2013.
This methodology is very similar to the
Performance Assessment Model;
however it incorporates an outcome
measures domain in addition to the
clinical process of care and patient
experience of care domains. While we
do not propose to adopt any outcome
measures for the FY 2013 Hospital VBP
program, we propose to adopt these
measures as part of an outcome
measures domain for FY 2014.
Therefore, we refer to the proposed
methodology as the Three-Domain
Performance Scoring Model and
describe how the outcomes measures
would apply when the domain is
eventually given weight.
We present below the proposed
Three-Domain Performance Scoring
Model, which includes setting
benchmarks and thresholds, scoring
hospitals on achievement and
improvement for three domains (clinical
a. Clinical Process of Care and Outcome
Measures Scoring Under the ThreeDomain Performance Scoring Model:
Setting Performance Benchmarks and
Thresholds
As stated above, section
1886(o)(5)(B)(ii) of the Act requires that
under the Hospital VBP performance
scoring methodology, hospital
performance scores be determined using
the higher of achievement or
improvement scores for each measure.
With respect to scoring hospital
performance on the proposed clinical
process of care and outcome measures,
we propose to use a methodology based
on the scoring methodology set forth in
the 2007 Report to Congress
Performance Assessment Model. Under
this methodology, a hospital’s
performance on each quality measure is
evaluated based on the higher of an
attainment score (herein, ‘‘achievement
score’’) in the performance period or an
improvement score, which is
determined by comparing the hospital’s
score in the performance period with its
score during a baseline period of
performance. In determining the
achievement score, we propose that
hospitals would receive points along an
achievement range, which is a scale
between the achievement threshold (the
minimum level of hospital performance
required to receive achievement points)
and the benchmark (the mean of the top
decile of hospital performance during
the baseline period). In determining the
improvement score, we propose that
hospitals would receive points along an
improvement range, which is a scale
between the hospital’s prior score on the
measure during the baseline period and
the benchmark.
Under this methodology, we propose
to establish the benchmarks and
achievement thresholds using national
data from a three-quarter baseline
period of July 1, 2009 through March 31,
2010. We discuss our rationale for
proposing to use this baseline period in
section D. of this proposed rule.
To define a high level of hospital
performance on a given measure, we
propose to set the benchmark at the
mean of the top decile of hospital scores
on the measure during the baseline
period. We believe this will ensure that
the benchmark represents demonstrably
high but achievable standards of
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excellence; in other words, the
benchmark will reflect observed scores
for the group of highest-performing
hospitals on a given measure.
We considered several options for
setting the achievement threshold,
including the 25th, 50% (median), and
75th percentile scores. The higher and
lower options were rejected for being
too stringent and too lenient,
respectively. Setting the achievement
threshold at the 50th percentile,
however, balances the agency’s goal to
reward only those hospitals that can
demonstrate a certain level of quality
with the desire to set the bar at an
attainable level. We decided that the
median score (that is, the point at which
the performance of the hospital is better
than the performance of half of all
hospitals during the baseline period)
would be an appropriate threshold for
earning some merit, that is, to earn one
or more points for achievement. The
higher the hospital’s achievement falls
over the achievement performance
standard, the higher the score, until the
hospital reaches what we believe to be
an empirical standard of excellence
(that is, the benchmark). Therefore, we
propose to set the achievement
threshold at the 50th percentile of
hospital performance on the measure
during the baseline period. Hospitals
will have to score at or above this
threshold to earn achievement points.
We believe that these proposed
definitions are in keeping with the
statutory requirements and reflect the
evidence-based approach for
determining thresholds and benchmarks
set forth in the 2007 Report to Congress.
b. Clinical Process of Care and Outcome
Measures Scoring Under the ThreeDomain Performance Scoring Model:
Scoring Hospital Performance Based on
Achievement
Like the Performance Assessment
Model set forth in the 2007 Report to
Congress, for each of the proposed
clinical process and outcome measures
that apply to the hospital, we propose
that a hospital would earn 0–10 points
for achievement based on where its
performance for the measure fell relative
to the achievement threshold (which we
propose above to define as performance
during the baseline period at the 50th
percentile) and the benchmark (which
we propose above to define as
performance during the baseline period
at the mean of the top decile), according
to the following formula:
[9 * ((Hospital’s performance period
score¥achievement threshold)/
(benchmark¥achievement
threshold))] + .5, where the hospital
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performance period score falls in
the range from the achievement
threshold to the benchmark
All achievement points would be
rounded to the nearest whole number
(for example, an achievement score of
4.5 would be rounded to 5). If a
hospital’s score was:
• Equal to or greater than the
benchmark, the hospital would receive
10 points for achievement
• Equal to or greater than the
achievement threshold (but below the
benchmark), the hospital would receive
a score of 1–9 based on a linear scale
established for the achievement range
(which distributes all points
proportionately between the
achievement threshold and the
benchmark so that the interval in
performance between the score needed
to receive a given number of
achievement points and one additional
achievement point is the same
throughout the range of performance
from the achievement threshold to the
benchmark).
• Less than the achievement
threshold (that is, the lower bound of
the achievement range), the hospital
would receive 0 points for achievement.
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c. Clinical Process of Care and Outcome
Measures Scoring Under the ThreeDomain Performance Scoring Model:
Scoring Hospital Performance Based on
Improvement
In keeping with the approach
analyzed for the 2007 Report to
Congress, for the proposed clinical
process of care and outcome measures,
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we propose that a hospital would earn
0–9 points based on how much its
performance on the measure during the
performance period improved from its
performance on the measure during the
baseline period. A unique improvement
range for each measure would be
established for each hospital that
defines the distance between the
hospital’s baseline period score and the
national benchmark for the measure (the
mean of the top decile), according to the
following formula:
[10 * ((Hospital performance period
score¥Hospital baseline period
score)/(Benchmark¥Hospital
baseline period score))]¥.5, where
the hospital performance score falls
in the range from the hospital’s
baseline period score to the
benchmark
All improvement points would be
rounded to the nearest whole number. If
a hospital’s score on the measure during
the performance period was:
• Greater than its baseline period
score but below the benchmark (within
the improvement range), the hospital
would receive a score of 0–9 based on
the linear scale that defines the
improvement range
• Equal to or lower than its baseline
period score on the measure, the
hospital would receive 0 points for
improvement.
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d. Examples To Illustrate Clinical
Process of Care and Outcome Measures
Scoring Under the Three-Domain
Performance Scoring Model
Three examples are presented to
illustrate how the proposed ThreeDomain Performance Scoring Model
would be applied in the context of the
proposed clinical process of care and
outcome measures. The hospitals were
selected from an empirical database
created from 2004–2005 data to support
the development of the Performance
Assessment Model, and all performance
scores are calculated for the pneumonia
measure, ‘‘patients assessed and given
pneumococcal vaccine.’’ Figure 1 shows
the scoring for Hospital B. The
benchmark calculated for the
pneumonia measure in this case was
0.87 (the mean value of the top decile
in 2004), and the achievement threshold
was 0.47 (the performance of the
median or the 50th percentile hospital
in 2004). Hospital B’s 2005 performance
rate of 0.91 during the performance
period for this measure exceeds the
benchmark, so Hospital B would earn 10
(the maximum) points for achievement.
The hospital’s performance rate on a
measure is expressed as a decimal. In
the illustration, Hospital B’s
performance rate of 0.91 means that 91
percent of applicable patients admitted
for pneumonia were assessed and given
the pneumococcal vaccine. (Because
Hospital B has earned the maximum
number of points possible for this
measure, its improvement score would
be irrelevant.)
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Figure 2 shows the scoring for another
hospital, Hospital I. As can be seen
below, the hospital’s performance on
this measure went from 0.21 (below the
achievement threshold) in the baseline
period to 0.70 (above the achievement
threshold) in the performance period.
Applying the achievement scale,
Hospital I would earn 6 points for this
measure, calculated as follows:
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[9 * ((0.70 ¥ 0.47)/(0.87 ¥ 0.47))] +
0.5 = 5.175 + 0.5 = 5.675, rounded to 6
points.
However, because Hospital I’s
performance during the performance
period is also greater than its
performance during the baseline period,
it would be scored based on
improvement as well. According to the
improvement scale, based on Hospital
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I’s period-to-period improvement, from
0.21 to 0.70, Hospital I would earn 7
points, calculated as follows:
[10 * ((0.70 ¥ 0.21)/(0.87 ¥ 0.21))] ¥
0.5 = 6.92, rounded to 7 points.
Because the higher of the two scores
is used for determining the measure
score, Hospital I would receive 7 points
for this measure (rounded to the nearest
whole number).
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period is lower than the achievement
threshold of 0.47, it receives 0 points
based on achievement. It would also
receive 0 points for improvement,
because its performance during the
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performance period is lower than its
performance during the baseline period.
In this example, Hospital L would
receive 0 points for the measure.
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In Figure 3 shown below, Hospital L’s
performance on the pneumonia measure
drops from 0.57 to 0.46 (a decline of
0.11 points). Because this hospital’s
performance during the performance
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e. Calculation of the Overall Clinical
Process of Care and Outcome Measure
Domain Scores Under the Three-Domain
Performance Scoring Model
We propose that both a hospital’s
overall clinical performance score and
outcome performance score would be
based on all measures that apply to the
hospital. We propose that a measure
applies to a hospital if, during the
performance period, the hospital treats
a minimum number of cases (which we
propose to define as 10 cases in section
F of this proposed rule) that meet the
technical specifications for reporting the
measure. We also propose that at least
4 measures within a domain must apply
to the hospital in order for the hospital
to receive a performance score on that
domain (this proposal is also discussed
more fully in section F of this proposed
rule). Thus, the number and type of
measures that apply to each hospital
will vary, depending on the services the
hospital provides (for example, some
hospitals may not perform percutaneous
coronary intervention; therefore, this
measure would not apply to them). As
proposed above, for each applicable
measure, a hospital would receive a
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score based on the higher of its
achievement and improvement scores.
Because the clinical process of care and
outcome measure performance scores
will be based only on the measures that
apply to the hospital, we propose to
normalize the domain scores across
hospitals by converting the points
earned for each domain to a percentage
of total points.
With respect to the clinical process of
care and outcome domains, we propose
that the points earned for each measure
that applies to the hospital would be
summed (weighted equally) to
determine the total earned points for the
domain:
Total earned points for domain = Sum
of points earned for all applicable
domain measures
Under the proposed approach, each
hospital would also have a
corresponding universe of total possible
points for each of the clinical process
and outcome domains calculated as
follows:
Total possible points for domain = Total
number of domain measures that
apply to the hospital multiplied by
10 points
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We also propose that the hospital’s
clinical process of care and outcome
domain scores would each be a
percentage, calculated as follows:
Domain score = Total earned points
divided by Total possible points
multiplied by 100%
As an example, four clinical process
of care measures apply to Hospital E,
and Hospital E reports data on at least
10 cases for each of these measures.
Under the proposed scoring
methodology discussed above, Hospital
E is awarded 9, 5, 3, and 10 points,
respectively, for these measures.
Hospital E’s total earned points for the
clinical process of care measure domain
would be calculated by adding together
all the points Hospital E was awarded,
resulting in a total of 27 points. Hospital
E’s total possible points would be the
total number of measures that apply to
the hospital (four measures) and for
which the hospital had the minimum
number of cases multiplied by 10
points, for a total of 40 points. Hospital
E’s clinical process of care domain score
would be the total earned points (that is,
27 points) divided by the total possible
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points (that is, 40 points) multiplied by
100, which yields a result of 67.5.
5. Scoring Patient Experience of Care
Measures (HCAHPS) Under the ThreeDomain Performance Scoring Model
Since the 2007 Report to Congress
was published, we have performed
additional analyses on methods of
scoring HCAHPS measures for purposes
of the Hospital VBP program using data
collected from a greater number of
hospitals and over a longer period of
time. We have found that the model laid
out in the 2007 Report to Congress has
good measurement properties and
functions as intended with respect to
achievement, consistency, and
improvement. We believe that the
scoring approach proposed here, which
is based on the HCAHPS model set forth
in the 2007 Report to Congress, reflects
both the interrelated nature of HCAHPS
dimensions and the importance of
providing incentives to hospitals to
improve on each of eight dimensions of
patient experience.
The scoring approach we propose for
HCAHPS performance for the FY 2013
Hospital VBP program captures eight
HCAHPS dimensions (seven composites
and one global rating of care) and would
seek to incentivize hospitals to improve
on each of the eight dimensions of
patient experience (See Table 4). We
propose that the 8 dimensions will be
structured similar to the 10 HCAHPS
items that we currently report on
Hospital Compare, except that we are
proposing to combine the cleanliness of
hospital environment and quietness of
hospital environment items into a single
dimension and to not include the
recommend the hospital item. We are
proposing these changes because we did
not want to give more weight to the two
items capturing environmental issues by
treating them as separate dimensions
and the ‘‘Recommend the hospital’’ item
is very similar to the included ‘‘Overall
rating’’ item.
We are proposing to score each of the
eight HCAHPS dimensions using an
approach that parallels the one we are
proposing to use to score the clinical
process measures, using an achievement
point range from 0–10 and an
improvement point range from 0–9,
with the total score on each HCAHPS
dimension being the higher of the
achievement or improvement score. In
order to ensure statistical reliability, we
are also proposing that, for inclusion in
the Hospital VBP program for FY 2013,
hospitals report a minimum of 100
HCAHPS surveys during the
performance period (we discuss this
proposal further in section F of this
proposed rule).
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In order to be consistent with what we
do under the Hospital IQR program, we
are also proposing to give hospitals that
have 5 or fewer HCAHPS-eligible
discharges in a month the option to not
submit HCAHPS surveys for that month
as part of their quarterly data
submission. However, in contrast to the
proposed clinical process of care
measure scoring methodology, under
which different numbers of measures
might apply to different hospitals, all
hospitals that report HCAHPS data
would be expected to report the
complete survey.
As we are proposing to do with
respect to scoring the proposed clinical
process of care measures, we are
proposing that achievement thresholds
and benchmarks would be used to score
hospital performance during the
performance period, and these
achievement thresholds and
benchmarks would be established using
data from the proposed baseline period.
Thus, a hospital’s achievement score
would be based on a fixed standard
rather than on its current standing
relative to its peers. The achievement
threshold for each HCAHPS dimension
would correspond to median
performance in the baseline period
(50th percentile performance).
Therefore, hospitals would earn points
for achievement if they performed at
least as well in the performance period
as the mid-performing hospital
performed during the baseline period.
The benchmark corresponds to excellent
performance observed in the baseline
period and we are proposing to set it
such that the maximum achievement
points (10 points) would be awarded if
the hospital performed at least at the
95th percentile of performance during
the baseline period. We are proposing to
set the actual benchmarks and
achievement thresholds for the FY 2013
Hospital VBP program using data from
the proposed baseline period (July 1,
2009 through March 31, 2010).
Similar to the proposed clinical
process measures, we are proposing that
each of the eight HCAHPS dimensions
would be given equal weight in
calculating the overall HCAHPS score.
However, unlike the proposed scoring
approach for the proposed clinical
process of care measures, we are
proposing to construct the patient
experience of care measures score for
the FY 2013 Hospital VBP using three
elements: Achievement points,
improvement points, and consistency
points.
As shown in Table 4, for each of the
eight HCAHPS dimensions we propose
for the FY 2013 Hospital VBP program,
scores would be based on the publicly
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reported adjusted proportions of best
category (‘‘top-box’’) responses. (Top-box
responses, as publicly reported on the
Hospital Compare website, are the most
positive responses to HCAHPS survey
questions.) Please note that the
‘‘Cleanliness and Quietness’’ dimension
is the average of the publicly reported
stand-alone ‘‘Cleanliness’’ and
‘‘Quietness’’ ratings.
TABLE 4—EIGHT PROPOSED HCAHPS
DIMENSIONS FOR THE FY 2013
HOSPITAL VBP PROGRAM
Dimension (Composite or stand-alone
item)
Constituent HCAHPS
survey items
1. Nurse communication.
(% ‘‘Always’’) .............
Nurse-Courtesy/Respect.
Nurse-Listen.
Nurse-Explain.
Doctor-Courtesy/Respect.
Doctor-Listen.
Doctor-Explain.
Cleanliness.
2. Doctor communication.
(% ‘‘Always’’) .............
3. Cleanliness and
quietness.
(% ‘‘Always’’) .............
4. Responsiveness of
hospital staff.
(% ‘‘Always’’) .............
5. Pain management
(% Always’’) ...............
6. Communication
about medications.
(% ‘‘Always’’) .............
7. Discharge information.
(% ‘‘Yes’’) ..................
8. Overall rating ........
Quietness.
Bathroom Help.
Call Button.
Pain Control.
Help with Pain.
New Medicine-Reason.
New Medicine-Side
Effects.
Discharge-Help.
Discharge-Systems.
Overall Rating.
a. Patient Experience of Care Measure
(HCAHPS) Scoring Under the ThreeDomain Performance Scoring Model:
Scoring Hospitals on Achievement
Section 1886(o)(3)(A) requires the
Secretary to establish performance
standards with respect to the measures
selected under the Hospital VBP
program for a performance period for a
fiscal year. The performance standards
must include levels of achievement and
improvement (section 1886(o)(3)(B)).
The scoring methodology we are
proposing to implement for HCAHPS
includes achievement, improvement
and consistency points. The
achievement and improvement points
are very similar to what is proposed for
clinical measures. The consistency
points measure whether hospitals are
meeting the achievement thresholds
across the eight proposed HCAHPS
dimensions, which we believe will
encourage hospitals to meet those
thresholds for all of them. Consistency
points are an additional form of
achievement measurement that
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complements achievement points
earned through hospital performance on
individual HCAHPS dimensions.
The first proposed component of the
patient experience of care/HCAHPS
Hospital VBP program scoring algorithm
is achievement points, which rewards
hospital performance at or above the
proposed baseline median on each of
the eight HCAHPS dimensions. A
minimum score of 0 corresponds to all
eight dimensions being below the
baseline median (that is, the dimensionspecific achievement threshold), while a
maximum score of 80 corresponds to all
eight dimensions being at or greater
than the 95th percentile from the
baseline period (that is, the dimensionspecific benchmark). We propose to
assign 0 to 10 points for each of the
eight HCAHPS dimensions as follows:
• If the hospital’s score on a
dimension is equal to or greater than the
benchmark (that is, the baseline 95th
percentile performance), the hospital
would receive 10 points for
achievement on that dimension
• If the hospital’s score on a
dimension is within the achievement
range (that is, equal to or greater than
the achievement threshold of 50th
percentile performance but below the
benchmark of 95th percentile
performance), the hospital would
receive a score of 1–9, based on a linear
scale established for the achievement
range and rounding to the nearest whole
point according to the following
formula:
((Hospital HCAHPS performance period
dimension score ¥ 50)/5) + 0.5 For
example, if performance on a given
dimension is at the 60th percentile,
the hospital would receive 3
achievement points, calculated as
follows: ((60 ¥ 50)/5) + 0.5 = 2 +
0.5 = 2.5, which would be rounded
to 3.
• If the hospital’s score on a
dimension is less than the achievement
threshold for the dimension (that is, less
than the 50th percentile of
performance), the hospital would
receive 0 points for achievement.
b. HCAHPS Performance Scoring Under
the Three-Domain Performance Scoring
Model: Scoring Hospitals on
Improvement
The second proposed component of
the HCAHPS Hospital VBP scoring
algorithm is improvement points. For
each HCAHPS dimension, a hospital
could earn from 0–9 improvement
points for each dimension depending on
how much its performance on the
dimension improved from its
performance on the dimension during
the baseline period. This proposed
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approach would recognize and
encourage improvement for each of the
eight HCAHPS dimensions. A unique
improvement range for each hospital on
each HCAHPS dimension would be
established. Improvement points would
be awarded proportionately and would
be rounded to the nearest whole
number. The score is based on the
proportion of possible improvement in
the performance period from the
baseline period score on a given
dimension to the benchmark on the
same dimension, We propose to
calculate improvement points for each
of the eight dimensions according to the
following formula:
[10*((Hospital performance period score
¥ Hospital baseline period score)/
(Benchmark ¥ Hospital baseline
period score))] ¥ 0.5, where the
hospital performance score falls in
the range from the hospital’s
baseline period score to the
benchmark
All improvement points would be
rounded to the nearest whole number. If
a hospital’s score on the measure during
the performance period was:
• Greater than its baseline period
score but below the benchmark (within
the improvement range), the hospital
would receive a score of 0–9 based on
the linear scale that defines the
improvement range
• Equal to or lower than its baseline
period score on the measure, the
hospital would receive 0 points for
improvement.
• If there is no improvement or if the
score from the baseline period was
already at the benchmark, the
improvement score is 0.
For example, if a hospital’s baseline
score on a given dimension was at the
45th percentile and the hospital’s score
on the dimension during the
performance period was at the 70th
percentile, the hospital’s improvement
points on that dimension would be 5,
calculated as follows:
[10 * ((70 ¥ 45)/(95 ¥ 45))] ¥ 0.5 = 4.5,
which would be rounded to 5.
c. HCAHPS Performance Scoring
Model: Calculation of Consistency
Points
The third proposed component of the
HCAHPS Hospital VBP scoring
algorithm is the consistency score. The
consistency score recognizes consistent
achievement across dimensions. To
ensure at least adequate performance
across all HCAHPS dimensions, we are
proposing that for the FY 2013 Hospital
VBP program hospitals earn consistency
points ranging from 0–20 based on how
many of their dimension scores meet or
exceed the achievement threshold. The
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purpose of the consistency score
(referred to as the ‘‘minimum
performance score’’ in the 2007 Report
to Congress), is to incentivize hospitals
to continually improve on all HCAHPS
dimensions to the point where their
score on each dimension is at or above
the achievement threshold. We believe
that providing this type of incentive that
applies to an entire domain is consistent
with promoting wider systems changes
within hospitals to improve quality.
We are proposing that a hospital
would receive 0 consistency points if its
performance on one or more HCAHPS
dimensions during the performance
period was at least as poor as the worstperforming hospital’s performance on
that dimension during the baseline
period. A hospital would receive a
maximum score of 20 consistency
points if its performance on all eight
HCAHPS dimensions was at or above
the achievement threshold (50% of
hospital performance during the
baseline period).
We propose for the FY 2013 Hospital
VBP program that a maximum of 20
consistency points would be awarded
proportionately based on the single
lowest of a hospital’s 8 HCAHPS
dimension scores during the
performance period compared to the
median baseline performance score for
that specific HCAHPS dimension. If all
8 of a hospital’s dimension scores
during the performance period were at
or above the 50th percentile
achievement threshold in the baseline
period, then that hospital would earn all
20 points. (That is, if the lowest of a
hospital’s eight HCAHPS dimension
scores was at or above the 50th
percentile of hospital performance on
that dimension during the baseline
period, then that hospital would earn
the maximum of 20 consistency points).
Consistency points would be awarded
proportionately according to the number
of percentiles the lowest dimension
score is between the 0th and 50th
percentile of hospital performance
during the baseline period. Consistency
points would be rounded to the nearest
whole number (for example, 9.5
consistency points would be rounded to
10 points). We propose to define the
lowest percentile as the lowest
dimension score among the eight
HCAHPS dimensions that would be
scored under the FY 2013 Hospital VBP
program. The formula for the HCAHPS
consistency score is as follows:
(2 * (lowest percentile/5))¥ 0.5,
rounded to the nearest whole
number, with a minimum of zero
and a maximum of 20 consistency
points
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equal to the 25th percentile of hospital
performance on that dimension during
the baseline period, then 10 (that is, (2
* (25/5)) ¥ 0.5 = 9.5, rounded to 10)
consistency points would be awarded to
that hospital.
• If a hospital’s score on all eight
HCAHPS dimensions were at or above
the achievement threshold (50th
percentile of hospital performance
during the baseline period), then 20
consistency points would be awarded to
that hospital.
Figure 5 shows that Hospital I’s
performance on the doctor
communication dimension rose from
the 42nd percentile during the baseline
period to the 64th percentile during the
performance period. Because Hospital
I’s performance during the performance
period exceeds the achievement
threshold of the 50th percentile,
Hospital I’s score would be in the
achievement range. According to the
achievement scale, Hospital I would
earn 3 achievement points. However, in
this case, the hospital’s performance in
the performance period has improved
from its performance during the
baseline period, so Hospital I would be
scored based on improvement as well as
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d. Examples To Illustrate HCAHPS
Measure Scoring Model
Examples are presented here to
illustrate how the proposed Three-
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Domain Performance Scoring Model
would apply in the context of scoring
the proposed HCAHPS dimensions. The
dimension used for this illustration is
doctor communication. Figure 4 shows
Hospital B’s scoring on the doctor
communication dimension. It was
placed at the 96th percentile, which
exceeded the benchmark. Thus,
Hospital B would earn the maximum of
10 points for achievement. Because this
is the highest number of achievement
points the hospital could attain for this
dimension, its improvement from its
baseline period score on this measure
would not be relevant.
achievement. Applying the
improvement scale, Hospital I’s periodto-period improvement from the 42nd to
the 64th percentile would earn it 3.65
improvement points which would be
rounded to 4 points. Using the greater
of the two scores, Hospital I would
receive 4 points for this dimension
(rounded to the nearest whole number).
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For example:
• If the lowest score a hospital
receives on an HCAHPS dimension is at
or below the 0th percentile of hospital
performance on that dimension during
the baseline period, then 0 consistency
points would be awarded to that
hospital.
• If the lowest score a hospital
receives on an HCAHPS dimension is
equal to the 10th percentile of hospital
performance on that dimension during
the baseline period, then 4 (that is, (2 *
(10/5)) ¥ 0.5 = 3.5, rounded to 4)
consistency points would be awarded to
that hospital.
• If the lowest score a hospital
receives on a HCAHPS dimension is
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In Figure 6, Hospital L’s performance
in the baseline period was at the 11th
percentile, and its performance declined
in the performance period to the 6th
percentile. Because Hospital L’s
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performance during the performance
period is lower than the achievement
threshold of the 50th percentile, it
would receive 0 points based on
achievement. Hospital L would also
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receive 0 points for improvement
because its performance during the
performance period is lower than its
performance during the baseline period.
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e. Calculating the Overall Patient
Experience of Care Domain (HCAHPS)
Performance Score
The proposed final step under the
proposed HCAHPS scoring methodology
for the FY 2013 Hospital VBP program
is to combine the three proposed
component scores into the overall
patient experience of care domain
(HCAHPS) performance score. We
propose to calculate the overall
HCAHPS performance score as follows:
1. For each of the eight dimensions,
determine the larger of the 0–10
achievement score and the 0–9
improvement score.
2. Sum these eight values to arrive at
a 0–80 HCAHPS base score.
3. Calculate the 0–20 HCAHPS
consistency score.
4. To arrive at the HCAHPS total
earned points, or HCAHPS overall score,
sum the HCAHPS base score and the
consistency score.
In summary, the overall HCAHPS
performance score is calculated as
follows:
HCAHPS total earned points = HCAHPS
base score + consistency score.
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6. Weighting of Hospital Performance
Domains and Calculation of the Hospital
VBP Total Performance Score
Section 1886(o)(5)(B)(iii) requires that
the methodology developed for
assessing the total performance of each
hospital must provide for the
assignment of weights for categories of
measures as the Secretary determines
appropriate. As discussed above in
section C. of this proposed rule, we have
proposed to group the measures for the
Hospital VBP program into domains,
which we would define as categories of
measures by measure type. For purposes
of the Hospital VBP program in FY
2013, we propose that two domains will
be scored, the clinical process of care
and patient experience of care. We
believe that hospital quality is
multifaceted, requiring adherence to
evidence-based practices, achieving
good clinical outcomes, and having
positive and effectual patient
experiences. In determining how to
appropriately weight quality measure
domains, we considered a number of
criteria. Specifically, we considered the
number of measures that we have
proposed to include in each domain and
the reliability of individual measure
data. We also considered the systematic
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effects of alternative weighting schemes
on hospitals according to their location
and characteristics (for example, by
region, size, and teaching status). We
also considered Departmental quality
improvement priorities. We strongly
believe that outcome measures are
important in assessing the overall
quality of care provided by hospitals.
While we believe that the addition of an
outcome domain will make public
valuable and important quality
information regarding hospital
performance, and bring needed
attention to patient outcomes, for
reasons previously discussed in section
II. C. of this proposed rule, we are not
proposing to include outcome measures
in the FY 2013 Hospital VBP program.
Taking all of these considerations into
account, we propose the use of a 70
percent clinical process of care and 30
percent patient experience of care
(HCAHPS) weighting scheme for the FY
2013 Hospital VBP program. We are
proposing this weighting scheme
because the 17 proposed clinical
process of care measures comprise all
but one of the measures we are
proposing to include in the FY 2013
Hospital VBP program. We believe
assigning a 30 percent weight to the
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patient experience of care domain is
appropriate because the HCAHPS
measure is comprised of eight
dimensions that address different
aspects of patient satisfaction. For the
FY 2014 Hospital VBP program, in
addition to proposing to use the 30-day
mortality claims-based measures
currently displayed on Hospital
Compare, we propose to adopt the
following 8 Hospital Acquired
Condition measures and 9 AHRQ
Patient Safety Indicator and Inpatient
Quality Indicator outcome measures:
Hospital Acquired Condition
measures:
• Foreign Object Retained After
Surgery
• Air Embolism
• Blood Incompatibility
• Pressure Ulcer Stages III & IV
• Falls and Trauma: (Includes:
Fracture, Dislocation, Intracranial
Injury, Crushing Injury, Burn, Electric
Shock)
• Vascular Catheter-Associated
Infections
• Catheter-Associated Urinary Tract
Infection (UTI)
• Manifestations of Poor Glycemic
Control
AHRQ Patient Safety Indicators
(PSIs), Inpatient Quality Indicators
(IQIs), and Composite Measures:
• PSI 06—Iatrogenic pneumothorax,
adult
• PSI 11—Post Operative Respiratory
Failure
• PSI 12—Post Operative PE or DVT
• PSI 14—Postoperative wound
dehiscence
• PSI 15—Accidental puncture or
laceration
• IQI 11—Abdominal aortic aneurysm
(AAA) repair mortality rate (with or
without volume)
• IQI 19—Hip fracture mortality rate
• Complication/patient safety for
selected indicators (composite)
• Mortality for selected medical
conditions (composite)
We believe that these outcome
measures provide important information
relating to treatment outcomes and
patient safety. All of these measures are
currently included in the Hospital IQR
program for the FY 2013 payment
determination (75 FR 50209). We also
believe that adding these outcome
measures would significantly improve
the correlation between patient
outcomes and Hospital VBP
performance. We will propose the FY
2014 Hospital VBP performance period
end date and performance standards for
these outcome measures in future
rulemaking. We solicit public comment
on what weight would be appropriate to
assign to the outcome domain in future
rulemaking.
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We propose to calculate a hospital’s
total performance score by multiplying
its performance on each domain by the
proposed weight for that domain (70
percent clinical process of care, 30
percent patient experience of care), and
adding those weighted scores together.
We solicit public comment on the
proposed domain weighting approach
and calculation of the total performance
score, and are particularly interested in
receiving comments regarding the utility
and appropriateness of alternative
methods.
Earlier in this proposed rule, we
articulated our principles for valuebased purchasing programs. In order to
address these principles in our
proposed hospital value-based
purchasing program, we considered
several additional factors when
developing our proposed performance
scoring methodology for the Hospital
Value-Based Purchasing Program. CMS
is actively seeking all the comments and
proposals about alternative scoring
methodologies that may achieve all
these principles in better, more efficient,
or more straightforward ways. New,
innovative ideas are particularly useful
to the Agency as we seek to create a
payment system fully aligned with the
overall health system aims of better
health, better health care, and more
efficient care through improvement.
Section 1886(o)(5)(B)(iv) states that
the Secretary may not set a minimum
performance standard in determining
the hospital performance score for any
hospital. We note that under the
proposed Three-Domain Performance
Scoring Model, the Secretary does not
set the minimum performance standard
for any hospital. Rather, the hospital in
effect sets its own minimum
performance standard based on how
well it performed during the baseline
period, and any improvement from that
performance is sufficient for the
hospital to earn improvement points.
7. Alternative Hospital Performance
Scoring Models Considered
Since the 2007 Report to Congress,
CMS has performed additional research
and analyses regarding alternative
scoring approaches for hospital valuebased purchasing. We primarily focused
on the Three-Domain Performance
Scoring Model, the Six-Domain
Performance Scoring Model, and the
Appropriate Care Model (ACM). We are
proposing to adopt the Three-Domain
Performance Scoring Model as
previously described.
The Appropriate Care Model (ACM),
also referred to as the ‘‘all-or-none’’
model, is intended to be a more patientcentric method of assessing hospital
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performance on the clinical process of
care measures. The ACM creates subdomains by topic for the clinical process
measures and is distinguished from the
other two models in that it requires
complete mastery for each topic area
(‘‘all-or-none’’) in the clinical process of
care domain at the patient level.
Under the ACM, the patient
encounter, rather than the clinical
process of care measure itself, becomes
the scored ‘‘event,’’ with a hospital
receiving 1 point if it successfully
provides to a patient the applicable
processes under all of the measures
within an applicable topic area, or 0
points if it fails to furnish one or more
of the applicable processes. The
hospital’s condition-specific ACM score
is the proportion of patients with the
condition who receive the appropriate
care as captured by the process
measures that fall within the topic area.
Within a condition, different sets of
clinical processes may apply to a
patient. For example, some AMI
patients should receive aspirin at arrival
but other AMI patients should not; some
AMI patients smoke and should receive
smoking cessation counseling, while
others do not smoke and do not need to
receive such counseling. Regardless of
the number of clinical process of care
measures within a topic that apply to a
patient, each patient encounter to which
a specific topic area applies weights
equally with respect to the hospital’s
score for the topic area. Patients
requiring many clinical processes
within a topic are not weighted more
heavily than patients requiring only a
few clinical processes. There is no
‘‘partial credit’’ given to the hospital for
a patient who is provided some, but not
all, applicable clinical processes within
a topic.
Under the ACM, CMS would
determine what percentage of a
hospital’s patients within each
condition or topic area (for example,
AMI, HF, PN, and SCIP) received all of
the applicable processes covered by all
of the measures that fall under that
topic. A hospital’s performance on each
topic area (that is, the percentage of
patients that received all the appropriate
processes) would then be scored along
achievement and improvement ranges
similar to those we have proposed for
the Three-Domain Performance Scoring
Model. These scores across the topic
areas would then be equally weighted
and combined to create a score for all
of the clinical process measures. The
hospitals would then be measured on
the outcome and patient experience of
care domains, just as in the ThreeDomain Performance Scoring Model.
The total performance score would be
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computed as a weighted average across
the three domains, calculated by
weighting the scores for each of the
domains.
With each performance scoring model
considered, we commissioned
independent researchers at Brandeis
University to examine the variation and
stability of the clinical process of care
domain under different combinations
for the number of cases (patients) and
number of measures and develop
minimum numbers of cases and
measures that provide a high level of
confidence in the meaningfulness of
performance scores across hospitals
while at the same time providing scores
for the largest possible number of
hospitals. Based on this research, we
concluded that in order to ensure the
statistical reliability of a hospital’s score
under the ACM model, the hospital
would need to have at least 25 patients
within a condition (or topic area) to be
measured on that condition and have
cases corresponding to at least two
conditions to receive an overall ACM
score.
Under the ACM, for each condition
measured in the clinical process of care
domain, a hospital may earn points for
achievement or for improvement. The
method for determining earned points
per condition in the ACM is analogous
to the way points are determined per
measure in the proposed Three-Domain
Performance Scoring Model.
Accordingly, the points a hospital earns
for each condition is the higher of its
points for achievement (that is,
performance above the achievement
threshold) or improvement (that is,
performance better than the hospital’s
own performance during the baseline
period). The hospital’s overall ACM
score for the clinical process of care
domain is the sum of its conditionspecific points equally weighted across
all conditions measured for the hospital.
Applied to the following five
conditions (AMI, HF, PN, SCIP, and
HAI), a hospital reporting on all five
conditions could earn a maximum of 50
points under the ACM, while a hospital
reporting only three conditions could
earn at most 30 points. The final overall
clinical process of care domain score for
a hospital under the ACM would be the
fraction of its actual sum of points
divided by its maximum possible points
(for example, 50 in most cases, but
possibly 30, 20, or 10 corresponding to
the number of conditions reported).
The Six-Domain Performance Scoring
Model, like the ACM, would create and
separately score individual sub-domains
at the topic level for the clinical process
measures. In other words, the clinical
process of care domain would be further
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broken down into sub-domains
characterized by condition (our earlier
analysis of the Six-Domain Performance
Scoring Model included the HAI
measures under the SCIP topic area,
using only the four following topic
areas, AMI, HF, PN, and SCIP). We
would assign intermediate scores to
each hospital for each of the clinical
process sub-domains (such as, AMI, HF,
PN, and SCIP). Like the Three-Domain
Performance Scoring Model, hospitals
would be scored on each measure in the
sub-domain and individual measures
(such as, SCIP–Card–2 and AMI–3)
would still be weighted equally within
a sub-domain. Scores across the topic
area sub-domains would then be equally
weighted and combined to create an
overall clinical process score. The total
performance score would be computed
as an average across domains, calculated
by weighting the scores for each of the
three domains. At least two clinical
process domains would be needed to
calculate a total performance score.
Based on the research conducted at
Brandeis University discussed above,
we concluded that a hospital would
need to report at least 1 measure
included within a domain (with a
minimum of 2 domains) and have 10
opportunities (that is, patients) included
in the measure. If an outcome domain
was included, a hospital would also
need to report on at least one of the
available outcome measures.
8. Hospital Performance Scoring Model
Comparisons
We assessed each of the models
discussed above for purposes of
structuring the performance scoring
methodology for the Hospital VBP
program. Specifically, we considered
the following conceptual and empirical
criteria:
• Impact on patients: The primary
purpose of the Hospital VBP program is
to drive improvements in clinical
quality, patient-centered care, and
efficiency. Thus, consideration of the
impact of the various models on quality
improvement in patient care is
paramount.
• Accuracy of comparisons made
between hospitals: The Hospital VBP
program should make fair comparisons
between hospitals based on total
performance scores that are affected
predominantly or exclusively by the
hospital’s performance on the
individual measures. However,
differences in the TPS between
hospitals may also be affected by
differences in the scope of services
offered, which would determine the mix
of measures that comprise the TPS for
each hospital. Thus, a critical aspect of
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developing and implementing the TPS
is facilitating equivalent and accurate
comparisons between hospitals.
• Rank Correlation Impact: In light of
the fact that the value-based incentive
payment amount will vary by hospital,
based on the hospital’s TPS, we must
consider how each model will affect
how hospitals rank in terms of their
performance.
• Extent of variance across hospitals:
In addition to accuracy, the second
important property of a TPS is that it
has sufficient variance to clearly
differentiate between hospitals. The
logic and purpose of the scoring is to
discriminate among hospitals according
to relative performance; hence, the TPS
should capture meaningful variation
and financial incentives should reflect
that variation.
• Number of hospitals that receive a
score from the Hospital VBP program:
The models for calculating the total
performance score use different criteria
for hospitals’ minimum cases per
measure and measures per domain.
Consequently, the number of hospitals
scored will differ depending on the
model used. Other things being equal, a
greater number of hospitals receiving
scores is preferable in our view.
We analyzed how each of the scoring
models discussed above best meet these
criteria by modeling hospital
performance on each model using data
from 2007–2008 for the baseline period
and 2008–2009 as the performance
period. As discussed above, the primary
difference between the Three-Domain
Performance Scoring Model and the SixDomain Performance Scoring Model is
that the Six-Domain Performance
Scoring model creates intermediate
scores at the topic level for the clinical
process measures, so that six domains
are scored (AMI, HF, PN, SCIP,
outcomes, and patient experience)
rather than three domains (clinical
process of care, outcomes, and patient
experience). The Six-Domain model
provides an intermediate, conditionspecific score for prevalent and/or highcost conditions in the Medicare
population that could provide a useful
summary when a more complete set of
measures becomes available for those
conditions. However, in light of the
current set of measures available for use
in the Hospital VBP program, we believe
that the intermediate scores by
condition would convey a false sense of
precision about the quality of care for
that condition. For this reason, and
because hospital total performance
scores that we modeled under the SixDomain Performance Scoring Model
were not substantively different from
those we modeled under the Three-
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Domain Performance Scoring Model, we
chose to focus our continued analysis
on the Three-Domain Performance
Scoring Model and the ACM. We
discuss the results of our analysis of the
Three-Domain Performance Scoring
Model and the ACM below.
The scoring of the clinical process of
care and outcome domains in the ThreeDomain Performance Scoring Model is
based on the Performance Assessment
Model presented in the 2007 Report to
Congress, but includes and scores the
outcome domain as a separate domain.
We believe that because each measure is
scored independently under the ThreeDomain Performance Scoring Model, the
model will provide useful information
to hospitals on aspects of care that may
require improvement. The ThreeDomain Performance Scoring Model
scores hospitals based on how they
performed with respect to each
opportunity to provide appropriate care
as defined by the measures, in effect
weighting hospital scores by service and
patient mix. In contrast with the ACM,
independent scoring provides
opportunities for hospitals to receive
credit for each measure for which they
meet the performance standard. In
addition, hospitals are scored on a curve
at the measure level such that they only
earn points when their performance on
a measure is better than their peers’
average performance during the baseline
period, or better than their own
previous performance, increasing the
accuracy of comparisons made between
hospitals. This aspect of the ThreeDomain Performance Scoring Model
differs from the ACM, because ACM
scoring results in higher scores for
hospitals that only report on ‘‘easier’’
measures (that is, measures for which
performance is high for most hospitals),
not every clinical process of care
measure for each condition will apply to
every hospital, and the ACM does not
award points for hospitals that furnish
most (but not all) recommended care
with respect to a clinical process of care
topic.
Furthermore, in the Three-Domain
Performance Scoring Model, the scoring
of the clinical process of care measures
in a single clinical process of care
domain is consistent with the current
level of precision on the measures. We
believe that given the current set of
measures available for adoption into the
Hospital VBP program at this time, the
intermediate scores created at the
condition or topic level under the ACM
would convey a false sense of precision
about the quality of care provided for
that condition. There are efforts in the
industry to derive sets of measures that
capture many aspects of quality for a
certain condition. The measures
currently in the Hospital IQR program
were not developed with that aim;
rather, they were developed and
implemented as the best single quality
measures for various conditions treated
in the hospital and, as such, serve better
as a proxy for overall quality than as a
precise accounting of quality for
individual topics. In other words, the
measures now available for the Hospital
VBP program do not represent all of the
processes that constitute best practices
for treating the condition in the
inpatient setting, but collectively
capture an array of clinical processes
that are valid indicators representative
of the overall quality of care provided in
the hospital inpatient setting.
We believe that the Three-Domain
Performance Scoring Model and the
ACM are similar in several ways. Rank
correlations of hospitals’ total
performance scores based on the two
models were extremely high (between
89 percent and 94 percent). With respect
to total performance score rank, most
hospitals remain in the same quintile
regardless of which model is used; only
8 to 18 percent of hospitals changed in
rank quintile due to model choice. In
addition, the number of hospitals with
a sufficient number of cases and
measures for inclusion under the ACM
criteria (that is, at least 25 patients in 2
conditions) is similar to the number of
hospitals qualifying under the criteria
that we are proposing below to use for
the Three-Domain Performance Scoring
Model (that is, at least 10 patients for 4
measures).
The ACM is considered to be ‘‘patient
focused’’ rather than ‘‘opportunity
focused.’’ Since the unit of scoring is the
patient encounter, and the hospital
earns a clinical process of care domain
score of zero for a patient if the hospital
fails to provide any of the applicable
processes covered by the measures in
the applicable topic area, we believe
that the hospital is likely to become
aware of all of the processes the patient
requires in order to treat the condition,
rather than thinking in terms of
individual opportunities. The ACM sets
a high bar for quality improvement and
sends a strong signal about complete
mastery for each individual topic area
(‘‘all-or-none’’) at the patient level. On
the other hand, we believe that for
complex patients or patients for whom
one or more processes are not needed,
the ACM model may provide a
disincentive to providing quality care.
Due to its all-or-nothing scoring
approach, the ACM loses patient
information that would have some effect
on the total performance score under the
Three-Domain Performance Scoring
Model, under which hospitals would
receive credit for all of the measures for
which it met the performance standard.
Furthermore, as a result of all-ornothing scoring, the ACM approach will
capture whether a patient received
appropriate care, but it does not
describe the extent of lacking care.
With regard to the extent of variation
between hospitals, in our analysis,
hospital performance scores modeled
under the ACM in general tended to be
lower than scores modeled under the
Three-Domain Performance Scoring
Model. These lower scores would, in
theory, allow more room for hospitals to
improve in future years.
We will continue analyzing
alternative performance scoring models,
including the ACM, and may consider
proposing to implement scoring models
other than the Three-Domain
Performance Scoring Model in the
future. We solicit public comments on
the proposed Three Domain
Performance Scoring Model as well as
other potential performance scoring
models.
9. Example of Applying the ThreeDomain Performance Scoring Model to
a Hospital and Calculating the Total
Performance Score
To illustrate the application of the
proposed Three-Domain Performance
Scoring Model, we offer the following
example:
For the performance period, Hospital
E reports and receives raw scores on the
measures as set forth in Table 5. (This
example uses data from 2007 as the
baseline period and 2009 as the
performance period.)
TABLE 5—EXAMPLES OF HOSPITAL RAW SCORES ON HOSPITAL VBP PERFORMANCE MEASURES
Domain
Condition
Measure name
Clinical Process of
Care.
HF–1 ....................
Achievement
threshold
Discharge Instructions.
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Hospital baseline
score
0.4
13JAP2
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TABLE 5—EXAMPLES OF HOSPITAL RAW SCORES ON HOSPITAL VBP PERFORMANCE MEASURES—Continued
Domain
Achievement
threshold
Hospital baseline
score
Measure name
HF–2 ....................
Evaluation of LVS
Function.
Pneumococcal
Vaccination.
Initial Antibiotic
Received Within
6 Hours of Hospital Arrival.
..............................
............................
..............................
..............................
60
..............................
............................
..............................
..............................
9
PN–2 ....................
PN–7 ....................
Patient Experience
of Care.
HCAHPS Base
Score†.
HCAHPS Consistency Score.
Benchmark
Hospital performance period score
Condition
0.957
1.0
0.353
0.727
0.844
0.985
0.357
0.583
0.949
1.0
0.846
1.0
† The HCAHPS base score is calculated by summing the higher of the achievement or improvement score for each of the 8 HCAHPS
dimensions.
Table 6 below depicts the individual
measure scores and total performance
score Hospital E would receive after
applying the proposed scoring
methodology described above.
TABLE 6—EXAMPLE OF HOSPITAL VBP SCORE CALCULATION
Achievement
points
Improvement
points
Earned points
(higher of
achievement of
improvement)
Domain
Condition
Clinical Process of Care ..........
HF–1 ........................................
HF–2 ........................................
PN–2 .......................................
PN–7 .......................................
HCAHPS Base Score .............
8
0
0
10
60
9
5
3
10
40
9
5
3
10
†60
HCAHPS Consistency Score ..
............................
............................
9
..................................................
............................
............................
............................
Patient Experience of Care
(HCAHPS).
Total Performance Score ..
†
67.5
69
0.6795
HCAHPS earned points are calculated by summing the higher of achievement or improvement points across the 8 HCAHPS dimensions.
10. Request for Comments—Proposed
FY 2013 Hospital Value-Based
Purchasing Performance Score
Methodology and Alternatives
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Domain score
As stated in Sections E(1) and E(2) of
this proposed rule, we considered both
statutorily mandated and additional
factors when assessing the proposed FY
2013 Hospital Value-Based Purchasing
program performance score
methodology and the alternatives
outlined in the previous sections. These
additional factors include (1) simplicity
and transparency of performance score
methods to hospitals; (2) alignment of
Hospital VBP performance score
methodology with other CMS ValueBased Purchasing programs; (3)
quantitative characteristics of the
measures and hospital-level data; (4) the
relative emphasis placed on
achievement and improvement in a
performance score methodology; (5)
elimination of unintended
consequences for rewarding
inappropriate hospital behaviors and
patient outcomes, and (6) use of most
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currently available measure data to
assess improvement in a performance
score methodology.
We solicit comment on the merits and
drawbacks about all of these factors on
our proposed performance score
methodology, and our performance
score methodology alternatives
described in this proposed rule. We are
particularly interested in all suggested
new, improved scoring methodology
alternatives that may achieve our
objectives in better, straightforward, or
more effective ways.
F. Applicability of the Value-Based
Purchasing Program to Hospitals
Section 1886(o)(1)(C) of the Act
specifies the applicability of the valuebased purchasing program to hospitals.
For purposes of the Hospital VBP
program, the term ‘‘hospital’’ is defined
under section 1886(o)(1)(C)(i) as a
‘‘subsection (d) hospital,’’ (as defined in
section 1886(d)(1)(B) of the Act).
Section 1886(d)(1)(B) of the Act defines
a ‘‘subsection (d) hospital’’ as a ‘‘hospital
located in one of the fifty States or the
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District of Columbia.’’ The term
therefore does not include hospitals
located in the territories or hospitals
located in Puerto Rico. Section
1886(d)(9)(A) of the Act separately
defines a ‘‘subsection (d) Puerto Rico
hospital’’ as a hospital that is located in
Puerto Rico and that ‘‘would be a
subsection (d) hospital if it were located
in one of the 50 states.’’ Therefore,
because 1886(o)(1)(C) does not refer to
‘‘subsection (d) Puerto Rico hospitals,’’
the Hospital VBP program would not
apply to hospitals located in Puerto
Rico. The statutory definition of a
subsection (d) hospital under section
1886(d)(1)(B), however, does include
inpatient, acute care hospitals located in
the State of Maryland. These hospitals
are not currently paid under the IPPS in
accordance with a special waiver
provided by section 1814(b)(3) of the
Act. Despite this waiver, the Maryland
hospitals continue to meet the
definition of a ‘‘subsection (d) hospital’’
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because they are hospitals located in
one of the 50 states. Therefore we
propose that the Hospital VBP program
will apply to acute care hospitals
located in the State of Maryland unless
the Secretary exercises discretion
pursuant to 1886(o)(1)(C)(iv), which
states that ‘‘the Secretary may exempt
such hospitals from the application of
this subsection if the State which is paid
under such section submits an annual
report to the Secretary describing how a
similar program in the State for a
participating hospital or hospitals
achieves or surpasses the measured
results in terms of patient health
outcomes and cost savings established
under this subsection.’’
The statutory definition of a
subsection (d) hospital also does not
apply to hospitals and hospital units
excluded from the IPPS under section
1886(d)(1)(B) of the Act, such as
psychiatric, rehabilitation, long term
care, children’s, and cancer hospitals. In
order to identify hospitals, we propose
that, for purposes of this provision, we
would adjust payments to hospitals as
they are distinguished by provider
number in hospital cost reports. We
propose that payment adjustments for
hospitals be calculated based on the
provider number used for cost reporting
purposes, which is the CMS
Certification Number (CCN) of the main
provider (also referred to as OSCAR
number). Payments to hospitals are
made to each provider of record.
Section 1886(o)(1)(C)(ii) sets forth a
number of exclusions to the definition
of the term ‘‘hospital.’’ First, under
section 1886(o)(1)(C)(ii)(I) a hospital is
excluded if it is subject to the payment
reduction under section
1886(b)(3)(B)(viii)(I) (the Hospital IQR
program) for the fiscal year. Therefore,
any hospital that is subject to the
Hospital IQR payment reduction
because it does not meet the
requirements for the Hospital IQR
program will be excluded from the
Hospital VBP program for the fiscal
year. We are concerned about the
possibility of hospitals deciding to ‘‘opt
out’’ of the Hospital VBP program by
choosing to not submit data under the
Hospital IQR program, thereby avoiding
both the base operating DRG payment
reduction and the possibility to receive
a value-based incentive payment,
although we recognize that these
hospitals would still be subject to the
Hospital IQR program reduction to their
annual payment increase for the fiscal
year. We intend to track hospital
participation in the Hospital IQR
program and welcome public comment
on this issue.
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With respect to hospitals for which
we have measure data from the
performance period but no measure data
from the baseline period (perhaps
because these hospitals were either not
open during the baseline period or
otherwise did not participate in the
Hospital IQR program during that
period), we are proposing that these
hospitals will still be included in the
Hospital VBP program, but that they
will be scored based only on
achievement. We invite public
comments on this approach and
welcome input on scoring hospitals
without baseline performance data
using this and other approaches.
Under section 1886(o)(1)(C)(ii)(II), a
hospital is excluded if it has been cited
by the Secretary for deficiencies during
the performance period that pose
immediate jeopardy to the health or
safety of patients. We are proposing to
interpret this to mean that any hospital
that is cited by the Centers for Medicare
and Medicaid through the Medicare
State Survey and Certification process
for deficiencies during the proposed
performance period (for purposes of the
FY 2013 Hospital VBP program, July 1,
2011–March 31, 2012) that pose
immediate jeopardy to patients will be
excluded from the Hospital VBP
program for the fiscal year. We are also
proposing to use the definition of the
term ‘‘immediate jeopardy’’ that appears
in 42 CFR 489.3.
Section 1886(o)(1)(C)(ii)(III) requires
the Secretary to exclude for the fiscal
year hospitals that do not report a
minimum number (as determined by the
Secretary) of measures that apply to the
hospital for the performance period for
the fiscal year.
Section 1886(o)(1)(C)(ii)(IV) requires
the Secretary to exclude for the fiscal
year hospitals that do not report a
minimum number (as determined by the
Secretary) of cases for the measures that
apply to the hospital for the
performance period for the fiscal year.
In determining the minimum number
of reported measures and cases under
sections 1886(o)(1)(C)(ii)(III) and (IV),
the Secretary must conduct an
independent analysis of what minimum
numbers would be appropriate. To
fulfill this requirement, we
commissioned Brandeis University to
perform an independent analysis that
examined technical issues concerning
the minimum number of cases per
measure and the minimum number of
measures per hospital needed to derive
reliable performance scores. This
analysis examined hospital performance
scores using data from 2007–2008 and
2008–2009. The researchers tested
different minimum numbers of cases
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and measures and concluded that the
most important factor in setting
minimum thresholds for the Hospital
VBP program is to determine a
combination of thresholds that allows
the maximum number of hospitals to be
scored reliably. We note that such
reliability depends on the combination
of the two thresholds. For example, if
we allowed the number of cases per
measure to be small (for example, 5
cases), we might still have reliable
overall scores if there were a sufficiently
large number of measures.
The independent analysis indicated
that a smaller number of cases would
yield less reliable results for any given
measure, ultimately affecting results,
when the measures were combined to
create the domain scores. Because the
proposed Hospital VBP scoring
methodology aggregates information
across all of the proposed measures, the
analysis considered various thresholds
for the minimum number of cases to
include in a measure. We recognized
that lowering the minimum number of
cases required for each measure would
allow a greater number of hospitals to
participate in the Hospital VBP
program. The analysis explored whether
a lower threshold for each individual
measure might be sufficient to make
composite measures (that is, measures
based on aggregations of individual
measures), more statistically reliable.
Brandeis researchers checked the
reliability of the total performance score
for hospitals with only 4 measures. One
approach was to randomly select 4, 6,
10, or 14 measures and to compare the
reliabilities that are determined using
these different sets of measures per
hospitals. The research found that using
4 randomly selected measures per
hospital did not greatly reduce betweenhospital reliability (particularly in terms
of rank ordering) from what would have
been determined using 10 or 14
measures. Examining hospitals with at
least 10 cases for each measure, the
analysis compared the reliability of
clinical process measure scores for
hospitals according to the number of
such measures reported. Whisker plots
and reliability scores revealed
comparable levels of variation in the
process scores for hospitals reporting
even a small number of measures as
long as the minimum of 10 cases per
measure was met. Based on this
analysis, we propose to establish the
minimum number of cases required for
each measure under the proposed Three
Domain Performance Scoring Model at
10, which we believe will allow us to
include more hospitals in the Hospital
VBP program.
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When examining the minimum
number of measures necessary to derive
reliable performance scores, the
independent analysis revealed that the
distribution of performance scores
varied depending on the number of
measures reported per hospital. The
whisker plots and reliability scores
demonstrated a clear difference in the
distribution of scores for hospitals
reporting 4 or more measures compared
with those reporting fewer than 4
measures.
We believe that setting the minimum
number of measures and cases as low as
is reasonable is an essential component
of implementing the Hospital VBP
program and will help to minimize the
number of hospitals unable to
participate due to not having the
minimum number of cases for a
measure, or the minimum number of
measures. Therefore, as we stated above,
we propose to exclude from hospitals’
total performance score calculation any
measures on which they report fewer
than 10 cases. We also propose to
exclude from the Hospital VBP program
any hospitals to which less than 4 of the
proposed measures apply.
We are also proposing that, for
inclusion in the Hospital VBP program
for FY 2013, hospitals must report a
minimum of 100 HCAHPS surveys
during the performance period. The
reliability of HCAHPS scores was
determined through statistical analyses
conducted by RAND, the statistical
consultant for HCAHPS. Based on these
analyses, we believe that a reliability
rate of 85 percent or higher is desired
for HCAHPS to ensure that true hospital
performance, rather than random
‘‘noise,’’ is measured. RAND’s analysis
indicates that HCAHPS data do not
achieve an 85 percent reliability level
across all eight HCAHPS dimensions
with a sample of less than 100
completed surveys.
As proposed in this section and in
section II. E. of this proposed rule,
hospitals reporting insufficient data to
receive a score on either the clinical
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process of care or HCAHPS domains
will not receive a total performance
score for the FY 2013 Hospital VPB
program.
We solicit public comments on our
proposals regarding the minimum
numbers of cases and measures
necessary for hospitals’ inclusion in the
Hospital VBP program. We note that
hospitals excluded from the Hospital
VBP program will be exempt from the
base operating DRG payment reduction
required under section 1886(o)(7) as
well as the possibility for value-based
incentive payments.
G. The Exchange Function
Section 1886(o)(6) of the Act governs
the calculation of value-based incentive
payments under the Hospital VBP
program. Specifically, section
1886(o)(6)(A) requires that in the case of
a hospital that meets or exceeds the
performance standards for the
performance period for a fiscal year, the
Secretary shall increase the base
operating DRG payment amount (as
defined in section 1886(o)(7)(D)), as
determined after application of a
payment adjustment described in
section 1886(o)(7)(B)(i), for a hospital
for each discharge occurring in the fiscal
year by the value-based incentive
payment amount. Section 1886(o)(6)(B)
defines the value-based incentive
payment amount for each discharge in
a fiscal year as the product of (1) the
base operating DRG payment amount for
the discharge for the hospital for such
fiscal year, and (2) the value-based
incentive payment percentage for the
hospital for such fiscal year. Section
1886(o)(6)(C)(i) provides that the
Secretary must specify a value-based
incentive payment percentage for each
hospital for a fiscal year, and section
1886(o)(6)(C)(ii) provides that in
specifying the value-based incentive
payment percentage, the Secretary must
ensure (1) that the percentage is based
on the hospital’s performance score, and
(2) that the total amount of value-based
incentive payments to all hospitals in a
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fiscal year is equal to the total amount
available for value-based incentive
payments for such fiscal year under
section 1886(o)(7)(A), as specified by
the Secretary.
Section 1886(o)(7) of the Act
describes how the value-based incentive
payments are to be funded. Under
section 1886(o)(7)(A), the total amount
available for value-based incentive
payments for all hospitals for a fiscal
year must be equal to the total amount
of reduced payments for all hospitals
under section 1886(o)(7)(B), as
estimated by the Secretary. Section
1886(o)(7)(B)(i) requires the Secretary to
adjust the base operating DRG payment
amount for each hospital for each
discharge in a fiscal year by an amount
equal to the applicable percent of the
base operating DRG payment amount for
the discharge for the hospital for such
fiscal year, and further requires that the
Secretary make these reductions for all
hospitals in the fiscal year involved,
regardless of whether or not the hospital
has been determined to have earned a
value-based incentive payment for the
fiscal year. With respect to fiscal year
2013, the term ‘‘applicable percent’’ is
defined as 1.0 percent, but the amount
gradually rises to 2 percent by FY 2017
(section 1886(o)(7)(C)).
The 2007 Report to Congress
introduced the exchange function as the
means to translate a hospital’s total
performance score into the percentage of
the value-based incentive payment
earned by the hospital. We believe that
the selection of the exact form and slope
of the exchange function is of critical
importance to how the incentive
payments reward performance and
encourage hospitals to improve the
quality of care they provide.
As illustrated in Figure 7, we
considered four mathematical exchange
function options: Straight line (linear);
concave curve (cube root function);
convex curve (cube function); and Sshape (logistic function).
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In determining which of these
exchange functions would be most
appropriate for translating a hospitals
TPS into a value-based incentive
payment percentage, we carefully
considered four aspects of each option.
First, we considered how each option
would distribute the value-based
incentive payments among hospitals.
Under section 1886(o)(7)(A) of the Act,
the total amount available for valuebased incentive payments for all
hospitals for a fiscal year must be equal
to the total amount of reduced payments
for all hospitals for such fiscal year, as
estimated by the Secretary. We interpret
this section to mean that the
redistribution of a portion of the IPPS
payment to all hospitals under the
Hospital VBP program must be
accomplished in a way that is estimated
to be budget neutral, without increasing
or decreasing the aggregate overall IPPS
payments made to the hospitals. As a
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result, if we award higher value-based
incentive payments to higher
performing hospitals, less money is
available to make value-based incentive
payments to lower performing hospitals.
The reverse is also true. If we give
higher value-based incentive payments
to lower performing hospitals, less
money is available to reward higher
performing hospitals. The form and
slope of each exchange function also
affects the level of value-based incentive
payments available to hospitals at
various performance levels. Under both
the cube and logistic functions, lower
incentive payments are available to
lower performing hospitals and
aggressively higher payments are
available for higher performing
hospitals. These functions therefore
distribute more incentive payments to
higher performing hospitals. Under the
cube root function, payments stay at
relatively lower levels for higher
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performing hospitals; this function
distributes more incentive payments to
lower performing hospitals. The linear
function moves more aggressively to
higher levels for higher performing
hospitals than the cube root function,
but not as aggressively as the logistic
and cube functions. It therefore
distributes more incentive payments to
higher performing hospitals than the
cube root function, but not as
aggressively as the logistic and cube
functions.
Second, we considered the potential
differences between the value-based
incentive payment amounts for
hospitals that do poorly and hospitals
that do very well. Due to the fact that
the cube root function distributes lower
payment amounts to higher performing
hospitals, the cube root function creates
the narrowest distribution of incentive
payments across hospitals. The linear is
next, followed by the logistic. The cube
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function, which most aggressively
moves to higher payment levels for
higher performing hospitals, creates the
widest distribution.
Third, we considered the different
marginal incentives created by the
different exchange function shapes. In
the case of the linear shape, the
marginal incentive does not vary for
higher or lower performing hospitals.
The slope of the linear function is
constant, so any hospital with a TPS
that is 0.1 higher than another hospital
would receive the same increase in its
value-based incentive payment across
the entire TPS range. For the other
shapes, the slope of the exchange
function creates a higher or lower
marginal incentive for higher or lower
performing hospitals. Steeper slopes at
any given point on the function indicate
greater marginal incentives for hospitals
to improve scores and obtain higher
payments at that point, while flatter
slopes indicate smaller marginal
incentives. If the slope is steeper at the
low end of performance scores than at
the high end, as with the cube root
function, hospitals at the low end have
a higher marginal incentive to improve
than hospitals at the high end. If the
slope is steeper at the high end, as with
the cube function, hospitals have a
higher marginal incentive to improve at
the high end than they do at the low
end.
Fourth, we weighed the relative
importance of having the exchange
function be as simple and
straightforward as possible.
Taking all of these factors into
account, we propose to adopt a linear
exchange function for the purpose of
calculating the percentage of the valuebased incentive payment earned by each
hospital under the Hospital VBP
program. The linear function is the
simplest and most straightforward of the
mathematical exchange functions
discussed above. The linear function
provides all hospitals the same marginal
incentive to continually improve. The
linear function more aggressively
rewards higher performing hospitals
than the cube root function, but not as
aggressively as the logistic and cube
functions. We propose the function’s
intercept at zero, meaning that hospitals
with scores of zero will not receive any
incentive payment. Payment for each
hospital with a score above zero will be
determined by the slope of the linear
exchange function, which will be set to
meet the budget neutrality requirement
of section 1886(o)(6)(C)(ii)(II) that the
total amount of value-based incentive
payments equal the estimated amount
available under section 1886(o)(7)(A). In
other words, we will set the slope of the
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linear exchange function for FY 2013 so
that the estimated aggregate value-based
incentive payments for FY 2013 are
equal to 1 percent of the estimated
aggregate base operating DRG payment
amounts for FY 2013. Analogous
estimates will be done for subsequent
fiscal years.
We believe that our proposed linear
exchange function ensures that all
hospitals have strong incentives to
continually improve the quality of care
they provide to their patients. We may
revisit the issue of the most appropriate
exchange function in future rulemaking
as we gain more experience under the
Hospital VBP program. We solicit public
comments on our proposed exchange
function and the resulting distribution
of value-based incentive payments.
We note that, in order to evaluate the
different exchange functions, we needed
to estimate the value-based incentive
payment amount. As noted previously,
section 1886(o)(6)(B) of the Act defines
the value-based incentive payment
amount as equal to the product of the
base operating DRG payment amount for
each discharge for the hospital for the
fiscal year and the value-based incentive
payment percentage specified by the
Secretary for the hospital for the fiscal
year. Section 1886(o)(7)(D)(i) defines the
base operating DRG payment with
respect to a hospital for a fiscal year as,
unless certain special rules apply, ‘‘the
payment amount that would otherwise
be made under subsection (d)
(determined without regard to
subsection (q)) for a discharge if
[subsection (o)] did not apply; reduced
by any portion of such payment amount
that is attributable to payments under
paragraphs (5)(A), (5)(B), (5)(F) and (12)
of subsection (d); and such other
payments under subsection (d)
determined appropriate by the
Secretary.’’ Therefore, for estimation
purposes, to calculate base operating
DRG payments, we estimated the total
payments using Medicare Part A claims
data and subtracted from this number
the estimates of payments made as
outlier payments (authorized under
section 1886(d)(5)(A)), indirect medical
education payments (authorized under
section 1886(d)(5)(B)), disproportionate
share hospital payments (authorized
under section 1886(d)(5)(F)), and lowvolume hospital adjustment payments
(authorized under section 1886(d)(12)).
We note that this approximation of base
operating DRG payments made for the
purpose of estimating the value-based
payment amount to evaluate the
different exchange functions is not a
policy proposal. We will propose a
definition of the term ‘‘base operating
DRG payment amount’’ under section
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1886(o)(7)(D), as well as how we would
implement the special rules for certain
hospitals described in section
1886(o)(7)(D)(ii), in future rulemaking.
We invite public comment to inform our
intended future policymaking on this
issue.
Furthermore, section 1886(o)(7)(A)
states that the total amount available for
value-based incentive payments for all
hospitals for a fiscal year shall be equal
to the total amount of reduced payments
for all hospitals for such fiscal year. To
calculate the total amount of reduced
payments, section 1886(o)(7)(B) states
that the base operating DRG payment
amount shall be reduced by an
applicable percent as defined under
section 1886(o)(7)(C). This applicable
percent is 1.0 percent for FY 2013, 1.25
percent for FY 2014, 1.5 percent for FY
2015, 1.75 percent for FY 2016, and 2
percent for FY 2017 and subsequent
years. To develop an estimation of the
value-based incentive payment amount
for the purposes of evaluating the
different exchange functions, we used
the FY 2013 1.0 as the applicable
percent. We multiplied an estimate
(described above) of the total aggregate
base operating DRG payments for
hospitals as defined under 1886(o)(1)(C)
by 1.0 percent in order to derive the
total amount available for value-based
incentive payments that was used in the
evaluation of the four exchange
functions.
H. Proposed Hospital Notification and
Review Procedures
Section 1886(o)(8) requires the
Secretary to inform each hospital of the
adjustments to payments to the hospital
for discharges occurring in a fiscal year
as a result of the calculation of the
value-based incentive payment amount
(section 1886(o)(6)) and the reduction of
the base operating diagnosis-related
group (DRG) payment amount (section
1886(o)(7)(B)(i)), not later than 60 days
prior to the fiscal year involved. We
propose to notify hospitals of the 1
percent reduction to their FY 2013 base
operating DRG payments for each
discharge in the FY 2013 IPPS rule,
which will be finalized at least 60 days
prior to the beginning of the 2013 fiscal
year. We expect to propose to
incorporate this reduction into our
claims processing system in January,
2013, which will allow the 1 percent
reduction to be applied to the FY 2013
discharges, including those that have
occurred beginning on October 1, 2012.
We will address the operational aspects
of the reduction as part of the FY 2013
IPPS rule.
Because the proposed performance
period would end only six months prior
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to the beginning of FY 2013, CMS will
not know each hospital’s exact total
performance score or final value-based
incentive payment adjustment 60 days
prior to the start of the 2013 fiscal year
on October 1, 2012. Therefore, we
propose to inform each hospital through
its QualityNet account at least 60 days
prior to October 1, 2012 of the estimated
amount of its value-based incentive
payment for FY 2013 discharges based
on estimated performance scoring and
value-based incentive payment
amounts, which will be derived from
the most recently available data. We
also propose that each hospital
participating in the Hospital VBP
program establish a QualityNet account
if it does not already have one for
purposes of the Hospital IQR program.
We further propose to notify each
hospital of the exact amount of its
value-based incentive payment
adjustment for FY 2013 discharges on
November 1, 2012. The value-based
incentive payment adjustment would be
incorporated into our claims processing
system in January 2013, which will
allow the value-based incentive
payment adjustment to be applied to the
FY 2013 discharges, including those
that have occurred beginning on
October 1, 2012.
Section 1886(o)(10)(A)(i) of the Act
requires the Secretary to make
information available to the public
regarding individual hospital
performance in the Hospital VBP
program, including: (1) Hospital
performance on each measure that
applies to the hospital; (2) the
performance of the hospital with respect
to each condition or procedure; and (3)
the total hospital performance score. To
meet this requirement, we propose to
publish hospital scores with respect to
each measure, each hospital’s conditionspecific score (that is, the performance
score with respect to each condition or
procedure, for example, AMI, HF, PN,
SCIP, HAI), each hospital’s domainspecific score, and each hospital’s total
performance score on the Hospital
Compare website. We note that we are
not proposing to use a hospital’s
condition-specific score for purposes of
calculating its total performance score
under the proposed Three-Domain
Performance Scoring Model.
Section 1886(o)(10)(A)(ii) requires the
Secretary to ensure that each hospital
has the opportunity to review and
submit corrections related to the
information to be made public with
respect to the hospital under section
1886(o)(10)(A)(i) prior to such
information being made public. As
stated above, we propose to derive the
Hospital VBP measures data directly
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from measures data submitted by each
hospital under the Hospital IQR
program. We propose that the
procedures we adopt for the Hospital
IQR program will also be the procedures
that hospitals must follow in terms of
reviewing and submitting corrections
related to the information to be made
public under section 1886(o)(10).
With respect to the FY 2013 Hospital
VBP program, we propose to make each
hospital’s Hospital VBP performance
measure score, condition-specific score,
domain-specific score, and total
performance score available on the
hospital’s QualityNet account on
November 1, 2012. We propose to
remind each hospital via the hospital’s
secure QualityNet account of the
availability of its performance
information under the Hospital VBP
program on this date. Pursuant to
section 1886(o)(10)(A)(ii), we propose to
provide hospitals with 30 calendar days
to review and submit corrections related
to their performance measure scores,
condition-specific scores, domainspecific scores and total performance
score.
Section 1886(o)(10)(B) requires the
Secretary to periodically post on the
Hospital Compare website aggregate
information on the Hospital VBP
program, including: (1) The number of
hospitals receiving value-based
incentive payments under the program
as well as the range and total amount of
such value-based incentive payments;
and (2) the number of hospitals
receiving less than the maximum valuebased incentive payment available for
the fiscal year involved and the range
and amount of such payments. We
propose to post aggregate Hospital VBP
information on the Hospital Compare
website in accordance with Section
1886(o)(10)(B). We will provide further
details on reporting aggregated
information in the future.
I. Proposed Reconsideration and Appeal
Procedures
Section 1886(o)(11)(A) of the Act
requires the Secretary to establish a
process by which hospitals may appeal
the calculation of a hospital’s
performance assessment with respect to
the performance standards (section
1886(o)(3)(A)) and the hospital
performance score (section 1886(o)(5)).
Under section 1886(o)(11)(B), there is no
administrative or judicial review under
section 1869, section 1878, or otherwise
of the following: (1) The methodology
used to determine the amount of the
value-based incentive payment under
section 1886(o)(6) and the
determination of such amount; (2) the
determination of the amount of funding
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available for the value-based incentive
payments under section 1886(o)(7)(A)
and payment reduction under section
1886(o)(7)(B)(i); (3) the establishment of
the performance standards under
section 1886(o)(3) and the performance
period under section 1886(o)(4); (4) the
measures specified under section
1886(b)(3)(B)(viii) and the measures
selected under section 1886(o)(2); (5)
the methodology developed under
section 1886(o)(5) that is used to
calculate hospital performance scores
and the calculation of such scores; or (6)
the validation methodology specified in
section 1886(b)(3)(B)(viii)(XI).
We will propose an appeals process
under section 1886(o)(11) in future
rulemaking. We invite public comment,
in general, on the structure and
procedure of an appropriate appeals
process. Specifically, CMS seeks
comment on the appropriateness of a
process that would establish an agencylevel appeals process under which CMS
personnel having appropriate expertise
in the Hospital VBP program would
decide the appeal. We seek insight on
what qualifications such personnel
should hold. Further, we invite
comment on how the appeals process
should be structured. Finally, we seek
public input on the timeframe in which
these appeals should be resolved.
J. Proposed FY 2013 Validation
Requirements for Hospital Value-Based
Purchasing
In the FY 2011 IPPS final rule (75 FR
50227 through 50229), we adopted a
validation process for the FY 2013
Hospital IQR program. We propose that
this validation process will also apply to
the FY 2013 Hospital VBP program. We
believe that using this process for both
the Hospital IQR program and the
Hospital VBP program is beneficial for
both hospitals and CMS because no
additional burden will be placed on
hospitals to separately return requested
medical records for the Hospital VBP
program. Because the measure data we
are using for the Hospital VBP program
is the same as the data we collect for the
Hospital IQR program, we believe that
we can ensure that the Hospital VBP
program measure data are accurate
through the Hospital IQR program
validation process.
In future rulemaking related to the
Hospital IQR program, we will consider
proposing refinements to our annual
Hospital IQR validation sample
selection, targeting, and annual
validation period for enhanced
alignment and use in the Hospital VBP
program. We seek to reduce hospital
burden and ensure that the information
we collect for both the Hospital IQR
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program and the Hospital VBP program
is accurate.
K. Additional Information
1. Monitoring and Evaluation
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As part of our ongoing effort to ensure
that Medicare beneficiaries receive highquality inpatient care, CMS plans to
monitor and evaluate the new Hospital
VBP program. Monitoring will focus on
whether, following implementation of
the Hospital VBP program, we observe
changes in access to and the quality of
care furnished to beneficiaries,
especially within vulnerable
populations. We will also evaluate the
effects of the new Hospital VBP program
in areas such as:
• Access to care for beneficiaries,
including categories or subgroups of
beneficiaries.
• Changes in care practices that might
adversely impact the quality of care
furnished to beneficiaries.
• Patterns of care suggesting
particular effects of the Hospital VBP
program (such as whether there are
changes in the percentage of patients
receiving appropriate care for
conditions covered by the measures); or
a change in the rate of hospital acquired
conditions.
• Best practices of high-performing
hospitals that might be adopted by other
hospitals.
We currently collect data on
readmission rates for beneficiaries
diagnosed with myocardial infarction,
heart failure, and pneumonia. We also
collect chart abstracted data on a variety
of quality of care indicators related to
myocardial infarction, heart failure,
pneumonia, and surgical care
improvement. These sources and other
available data will provide the basis for
early examination of trends in care
delivery, access, and quality.
Assessment of the early experience with
the Hospital VBP program will allow us
to create an active learning system,
building the evidence base essential for
guiding the design of future Hospital
VBP programs and enabling CMS to
address any disruptions in access or
quality that may arise. These ongoing
monitoring and evaluation efforts will
be part of CMS’s larger efforts to
promote improvements in quality and
efficiency, both within CMS and
between CMS and hospitals in the
Hospital VBP program. We welcome
public comments regarding approaches
to monitoring and evaluating the
Hospital VBP program.
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2. Electronic Health Records (EHRs)
a. Background
Starting with the FY 2006 IPPS final
rule, we have encouraged hospitals to
take steps toward the adoption of EHRs
(also referred to in previous rulemaking
documents as electronic medical
records) that will allow for reporting of
clinical quality data from the EHRs
directly to a CMS data repository (70 FR
47420 through 47421). We encouraged
hospitals that are implementing,
upgrading, or developing EHR systems
to ensure that the technology obtained,
upgraded, or developed conforms to
standards adopted by HHS. We
suggested that hospitals also take due
care and diligence to ensure that the
EHR systems accurately capture quality
data and that, ideally, such systems
provide point of care decision support
that promotes optimal levels of clinical
performance.
We also continue to work with
standard setting organizations and other
entities to explore processes through
which EHRs could speed the collection
of data and minimize the resources
necessary for quality reporting as we
have done in the past.
We note that we have initiated work
directed toward enabling EHR
submission of quality measures through
EHR standards development and
adoption. We have sponsored the
creation of electronic specifications for
quality measures for the hospital
inpatient setting, and will also work
toward electronically specifying
measures selected for the Hospital IQR
program and the Hospital VBP program.
b. HITECH Act EHR Provisions
The HITECH Act (Title IV of Division
B of the ARRA, together with Title XIII
of Division A of the ARRA) authorizes
payment incentives under Medicare for
the adoption and use of certified EHR
technology beginning in FY 2011.
Hospitals are eligible for these payment
incentives if they meet requirements for
meaningful use of certified EHR
technology, which include reporting on
quality measures using certified EHR
technology. With respect to the
selection of quality measures for this
purpose, under section 1886(n)(3)(A)(ii)
of the Act, as added by section 4102 of
the HITECH Act, the Secretary shall
select measures, including clinical
quality measures, that hospitals must
provide to CMS in order to be eligible
for the EHR incentive payments. With
respect to the clinical quality measures,
section 1886(n)(3)(B)(i) of the Act
requires the Secretary to give preference
to those clinical quality measures that
have been selected for the Hospital IQR
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2485
program under section
1886(b)(3)(B)(viii) of the Act or that
have been endorsed by the entity with
a contract with the Secretary under
section 1890(a) of the Act. Any clinical
quality measures selected for the
HITECH incentive program for eligible
hospitals must be proposed for public
comment prior to their selection, except
in the case of measures previously
selected for the Hospital IQR program
under section 1886(b)(3)(B)(viii) of the
Act.
Thus, the Hospital IQR program and
Hospital VBP Program have important
areas of overlap and synergy with
respect to the reporting of quality
measures under the HITECH Act using
EHRs. We believe the financial
incentives under the HITECH Act for
the adoption and meaningful use of
certified HER technology by hospitals
will encourage the adoption and use of
certified EHRs for the reporting of
clinical quality measures under the
Hospital IQR program which are
subsequently used for the Hospital VBP
Program.
We note that the provisions in this
proposed rule do not implicate or
implement any HITECH statutory
provisions. Those provisions are the
subject of separate rulemaking and
public comment.
L. QIO Quality Data Access
The mission of the Quality
Improvement Organization (QIO)
Program, as authorized under section
1862(g) and Part B of title XI of the Act,
is to promote the effectiveness,
efficiency, economy, and quality of
services delivered to Medicare
beneficiaries. We contract with one
organization in each state, as well as the
District of Columbia, Puerto Rico, and
the U.S. Virgin Islands, to serve as that
state/jurisdiction’s QIO. QIOs are
private, usually not-for-profit
organizations, which are staffed mostly
by doctors and other health care
professionals. These professionals are
trained to review medical care and help
beneficiaries with complaints about the
quality of care and to implement
improvements in the quality of care
available throughout the spectrum of
care. Over time, QIOs have been
instrumental in advancing national
efforts that motivate providers to
improve the quality of Medicare
services, and in measuring and
improving outcomes of quality.
Data collected by QIOs to accomplish
their mission represent an important
tool for CMS in our efforts to improve
quality. QIOs collect survey,
administrative, and medical records
data in order to monitor and assess
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provider performance. The
confidentiality and disclosure
requirements associated with QIO
information are set forth in Section 1160
of the Act. In particular, this section
stipulates that QIOs are not Federal
agencies for purposes of the Freedom of
Information Act and specifies that ‘‘any
data or information acquired by [a QIO]
in the exercise of its duties and
functions shall be held in confidence
and shall not be disclosed to any
person.’’ The section then authorizes
certain exceptions that allow
disclosures, including the authority of
the Secretary to prescribe additional
exceptions ‘‘in such cases and under
such circumstances as the Secretary
shall by regulations provide * * * .’’
Implementing regulations governing the
QIO confidentiality and disclosure
requirements were issued in 1985 (see
50 FR 15347, April 17, 1985). In
accordance with section 1881(c)(8),
section 1160 and the confidentiality and
disclosure requirements also apply to
End Stage Renal Disease Networks.
A key aspect of these regulations is
the significant restriction placed on a
QIO’s ability to disclose QIO
information, in particular information
related to a Quality Review Study
(QRS). A QRS is defined in § 480.101(b)
as ‘‘an assessment, conducted by or for
a QIO, of a patient care problem for the
purpose of improving patient care
through peer analysis, intervention,
resolution of the problem and followup.’’ QIOs are instrumental in collecting,
maintaining, and processing certain data
associated with the Hospital Inpatient
Quality Reporting Program. Such data is
considered to be QRS data. As such,
these data are subject to the increased
restrictions placed on disclosures of
QRS information set forth in § 480.140
of the QIO regulations. Section 480.140
even places stringent restrictions on a
QIO’s ability to disclose to CMS. While
the QIO regulations have gone largely
unchanged since 1985, the regulations
were recently updated to account for
CMS’ expanded role in quality
reporting. Specifically, § 480.140 was
amended to add a new subparagraph (g),
which ensures that CMS has access to
QRS information collected as part of the
Hospital Inpatient Quality Reporting
Program, following hospital review of
the data. However, CMS’s access is
restricted to the sole purpose of
conducting certain activities related to
MA organizations, as described in
§ 422.153. See 75 FR 19678, 19759
(April 15, 2010). CMS continues to be
limited in other areas of quality
reporting based on the current
regulatory restrictions.
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In fact, many of the same regulatory
restrictions that impact CMS’ ability to
properly coordinate quality reporting
have also impacted CMS’ ability to
oversee and plan other QIO program
activities and Departmental initiatives.
As previously noted, the QIO
regulations were originally issued in
1985. Although these regulations have
not undergone significant change, there
have been significant changes both
within and outside the QIO program
directly impacting the way the QIOs and
CMS conduct business. In 1985,
computers were still in their infancy,
and QIO review activities were
primarily conducted onsite at the
provider’s and/or practitioner’s place of
business. Similarly, CMS’ oversight
responsibilities were conducted onsite
at the QIOs’ offices. The QIO program
regulations were written based on this
reality. Additionally, the original
restrictions were designed to enhance
provider and practitioner participation
in the QRS process, and in fact, were
considered necessary to obtain the frank
and open communication needed to
improve the quality of health care.
Since 1985 however, we have seen
enormous technological advances,
including improvements in the ability to
electronically exchange large amounts
of data safely and securely through the
internet. Moreover, several laws, most
notably the Health Insurance Portability
and Accountability Act (HIPAA) and the
Federal Information Security and
Management Act (FISMA), have been
established to protect sensitive
information. In addition, despite the
QIOs continued focus on information
obtained directly from providers and
practitioners, QIOs also obtain a large
amount of CMS claims data
electronically to complete their review
activities. During this same time period,
the QIO program has expanded and now
includes more emphasis on quality
reporting and additional
responsibilities, for example, a broader
range of beneficiary appeals of provider
discharges. In turn, CMS’
responsibilities have also been
broadened both in terms of
programmatic responsibilities, for
example, quality reporting, and its
contractor oversight responsibilities.
Moreover, there are various initiatives
designed to ensure transparency of our
programs, as well as the operations of
individual providers and practitioners.
We have also identified several
unintended consequences resulting
from these regulatory restrictions, which
need to be addressed to ensure better
management of the QIOs. This includes
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improvements related to CMS’ oversight
of QIO physician reviewers.
In light of the above, we are proposing
several changes to the QIO regulations.
We are amending the definition of the
QIO review system in § 480.101(b) to
include CMS. The QIO review system
currently consists of the QIO and the
organizations and individuals who
either assist the QIO or are directly
responsible for providing care or for
making review determinations with
respect to that care. Particularly in the
area of quality reporting, there is a need
for increased coordination between
CMS and the QIOs, which includes
exchanges of data so that CMS can
better manage and respond to new
information.
We are also modifying § 480.130 to
clarify the Department’s general right to
access non-QRS confidential
information. We have made it clear that
this provision includes Departmental
components, including CMS as well as
the Center for Disease Control and
Prevention including those related to
data exchanges associated with the
National Health Care Safety Network.
Additionally, we are modifying
§ 480.139(a) to remove limitations on
CMS’ access to information regarding
the QIO’s internal deliberations (as
defined in § 480.101(b). The current
regulation authorizes CMS’ access to
information in ‘‘deliberations,’’ but
limits that access to onsite ‘‘at the QIO
office or at a subcontracted
organization.’’ This limitation is
unrealistic in light of today’s
technologically advanced business
environment.
For the same reasons, we have
modified § 480.140 to eliminate the
onsite restriction to CMS’ access to QRS
data. In addition to the reasoning we
have presented above, we considered
this change necessary in order to create
a more consistent approach to how and
when we could gain access to QRS
information. In our recent addition of
subparagraph (g) to § 480.140, the
‘‘onsite’’ limitation was removed only in
the context of MA organizations. We
now see no reason to confine this
change to such a narrow purpose. As a
general matter, CMS must have access to
QRS information not only for quality
reporting purposes but also to ensure
proper oversight and management of the
QIOs. This includes access for the
evaluation of specific contractor
performance issues and for the longterm planning of the QIO program. In
addition, the current state of technology,
the use of electronic exchanges of data
and information, and the speed at which
data must be exchanged to ensure
accomplishment of our work, warrants
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the elimination of the restriction that
data can only be accessed ‘‘onsite’’ at the
QIO. We also considered the fact that
the current ‘‘onsite’’ limitation does not
establish realistic limits on the use of
data CMS views onsite. While actual
copies of materials cannot be removed
from an onsite location, it is unlikely
that the ‘‘onsite’’ restriction adequately
prevents CMS from ‘‘taking away’’
information it has learned while
viewing that information. Thus, the
change presents a more realistic
approach to access in light of today’s
environment. It will enable CMS to
operate more efficiently, and account for
the current information exchange
methodologies used throughout the
world. In fact, we are asking for
comments regarding whether the
‘‘onsite’’ restriction should be eliminated
entirely from subparagraph (a) of section
480.140. In order to reflect the specific
changes we are now proposing in
section 480.140, we are making
corresponding changes in § 422.153 to
ensure consistency between the two
provisions.
In general, the changes will not only
enable CMS to better monitor its
programs and contractors, but will also
help to ensure that CMS has access to
information in a timely manner to
account for any unintended
consequences to patient care resulting
from its programs. This increased access
to QIO information is vital to achieving
CMS’ goal of developing a performancebased incentive payment program that
rewards providers for high-quality care.
Access to this data will enhance CMS’
efforts to create a Hospital VBP program
based on quality of care. The changes
will also facilitate CMS’ effort to
improve coordination with its
contractors. Moreover, CMS will be
positioned to better leverage
opportunities to improve the quality of
health care and to oversee its contractor
activities with less cost, including costs
associated with travel.
In addition to the proposed changes,
we are also asking for comments
regarding the disclosure of QIO
information to researchers. Historically,
QIOs have not disclosed confidential
QIO information to researchers.
However, we recognize the value that
research can offer in improving the
quality of health care, and researchers
frequently contact QIO program
representatives to gain access to QIO
information. Thus, we are requesting
comments on whether researchers
should be allowed access to QIO
information. This includes access to
confidential information associated with
quality review studies. Moreover, we are
requesting comments on the process
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that should be used to evaluate these
requests, for example, enabling QIOs to
independently assess such requests or
using the current CMS Privacy Board
structure. Insight regarding criteria to be
used in evaluating these requests should
also be provided.
III. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995.
IV. 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.
V. Regulatory Impact Statement
A. Statement of Need
The objectives of the Hospital VBP
program include to transform how
Medicare pays for care and to encourage
hospitals to continually improve the
quality of care they provide. In
accordance with section 1886(o) of the
Act, we have proposed to accomplish
these goals by providing incentive
payments based on hospital
performance on quality measures. This
proposed rule was developed based on
extensive research we conducted on
hospital value-based purchasing, some
of which formed the basis of the 2007
Report to Congress, as well as extensive
stakeholder and public input. The
proposed approach reflects the statutory
requirements and the intent of Congress
to promote increased quality of hospital
care for Medicare beneficiaries by
aligning a portion of hospital payments
with performance.
B. Overall Impact
We have examined the impact of this
rule as required by Executive Order
12866 on Regulatory Planning and
Review (September 30, 1993), 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,
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2487
1999) and the Congressional Review Act
(5 U.S.C. 804(2)).
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). To provide funding for
value-based incentive payments,
beginning in fiscal year 2013 and in
each succeeding fiscal year, section
1886(o)(7) of the Act governs the
funding for the value-based incentive
payments and requires the Secretary to
reduce the base operating DRG payment
amount for a hospital for each discharge
in a fiscal year by an amount equal to
the applicable percent of the base
operating DRG payment amount for the
discharge for the hospital for such fiscal
year. We anticipate defining the term
‘‘base operating DRG amount’’ in future
rulemaking. For purposes of this
proposed rule, we have limited our
analysis of the economic impacts to the
value-based incentive payments. As
required by section 1886(o)(7)(A), total
reductions for hospitals under section
1886(o)(7)(B) must be equal to the
amount available for value-based
incentive payments under section
1886(o)(6), resulting in a net budgetneutral impact. Overall, the distributive
impact of this proposed rule is
estimated at $850 million for FY 2013.
Therefore, this proposed rule is
economically significant and thus a
major rule under the Congressional
Review Act.
The objectives of the Hospital VBP
program include to transform how
Medicare pays for care and to encourage
hospitals to continually improve the
quality of care they provide. In
accordance with section 1886(o) of the
Act, we have proposed to accomplish
these goals by providing incentive
payments based on hospital
performance on quality measures. This
proposed rule was developed based on
extensive research we conducted on
hospital value-based purchasing, some
of which formed the basis of the 2007
Report to Congress, as well as extensive
stakeholder and public input. The
proposed approach reflects the statutory
requirements and the intent of Congress
to promote increased quality of hospital
care for Medicare beneficiaries by
aligning a portion of hospital payments
with performance.
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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
hospitals and most other providers and
suppliers are considered to be small
entities, either by nonprofit status or by
having revenues $34.5 million or less in
any 1 year. Individuals and States are
not included in the definition of a small
entity.
Guidance issued by the Department of
Health and Human Services interpreting
the RFA considers effects to be
economically significant if they reach a
threshold of 3 to 5 percent or more of
total revenues or costs. Among the 3,092
hospitals that would be participating in
the Hospital VBP program, we estimate
that percent increases in payments
resulting from this proposed rule will
range from 0.0236 percent for the
lowest-scoring hospital to 1.817 percent
for the highest-scoring hospital. When
the reduction in base DRG operating
payments to hospitals required under
section 1886(o)(7) is taken into account,
roughly half of participating hospitals
will receive a net increase in payments
and half will receive a net decrease in
payments. However, we estimate that no
participating hospital will receive more
than a net 1 percent increase or decrease
in payments. This falls well below the
threshold for economic significance
established by HHS for requiring a more
detailed impact assessment under the
RFA. Thus, we are not preparing an
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analysis under the RFA because the
Secretary has determined that this
proposed rule would 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
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
an urban area and has fewer than 100
beds. We are not preparing an analysis
under section 1102(b) of the Act because
the Secretary has determined that this
proposed rule would not have a
significant impact on the operations of
a substantial number of small rural
hospitals.
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 would not
mandate any requirements for State,
local, or tribal governments, nor would
it affect private sector costs.
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
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requirement costs on State and local
governments, preempts State law, or
otherwise has Federalism implications.
As stated above, this final rule would
not have a substantial effect on State
and local governments.
C. Anticipated Effects
Table 7 displays our analysis of the
distribution of possible total
performance scores based on 2009 data,
providing information on the estimated
impact of this proposed rule. Valuebased incentive payments for the
estimated 3,092 hospitals participating
in Hospital VBP are stratified by
hospital characteristic, including
geographic region, urban/rural
designation, capacity (number of beds),
and percentage of Medicare utilization.
For example, line 4 of Table 7 shows the
estimated value-based incentive
payments for the East South Central
region, which includes the states of
Alabama, Kentucky, Mississippi, and
Tennessee. Column 2 relates that, of the
3,092 participating hospitals, 301 are
located in the East South Central region.
Column 3 provides the estimated mean
value-based incentive payment to those
hospitals, which is 1.021 percent. The
next columns provide the distribution of
scores by percentile; we see that the
value-based incentive percentage
payments for hospitals in the East South
Central region range from 0.550 at the
5th percentile to 1.482 at the 95th
percentile, while the value-based
incentive payment at the 50th percentile
is 1.023 percent.
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1.044
1.002
0.989
0.995
0.985
0.960
1.008
1.016
1.007
1.083
0.955
1.041
1.022
1.021
1.083
1.014
0.980
0.935
Mean
0.990
1.016
1.005
1.02
1,045
939
481
279
151
197
1,199
1,010
883
138
370
518
475
301
248
457
201
384
N = 3,092
237
1,508
1,148
196
0.542
0.528
0.524
0.52
0.491
0.500
0.586
0.577
0.575
0.562
0.552
0.551
0.487
0.660
0.542
0.551
0.555
0.550
0.638
0.477
0.584
0.434
5th
0.639
0.642
0.637
0.60
0.617
0.598
0.662
0.668
0.700
0.652
0.646
0.646
0.607
0.751
0.619
0.661
0.652
0.634
0.721
0.597
0.650
0.551
10th
0.798
0.818
0.804
0.80
0.814
0.815
0.803
0.821
0.837
0.766
0.815
0.817
0.788
0.935
0.766
0.822
0.840
0.810
0.866
0.784
0.822
0.755
25th
1.012
1.020
1.008
1.02
1.047
1.015
0.996
1.022
0.982
0.960
1.014
1.015
1.009
1.088
0.963
1.039
1.025
1.023
1.075
0.997
0.986
0.951
50th
Percentile
1.164
1.224
1.206
1.28
1.284
1.201
1.175
1.167
1.135
1.146
1.206
1.209
1.239
1.276
1.152
1.255
1.214
1.235
1.283
1.248
1.159
1.126
75th
1.352
1.381
1.381
1.42
1.456
1.360
1.323
1.293
1.307
1.265
1.370
1.379
1.398
1.391
1.288
1.420
1.380
1.413
1.470
1.432
1.336
1.290
90th
1.451
1.459
1.482
1.53
1.575
1.452
1.392
1.379
1.414
1.314
1.449
1.484
1.499
1.434
1.352
1.499
1.472
1.482
1.567
1.563
1.396
1.383
95th
† Note: Because sufficient 2009 data was not available at the time of publication of this proposed rule, the measures SCIP-Card-2 and SCIP-Inf-4 were not included in the calculation of
estimated incentive rates. However, we believe that no significant change in estimated incentive rates results from the omission of these measures.
Region:
New England ............................................................
Middle Atlantic ..........................................................
South Atlantic ...........................................................
East North Central ....................................................
East South Central ...................................................
West North Central ...................................................
West South Central ..................................................
Mountain ...................................................................
Pacific .......................................................................
Urban/Rural:
Large Urban .............................................................
Other Urban ..............................................................
Rural .........................................................................
Capacity (by # beds):
1 to 99 beds .............................................................
100 to 199 beds .......................................................
200 to 299 beds .......................................................
300 to 399 beds .......................................................
400 to 499 beds .......................................................
500+ beds ................................................................
Medicare Utilization:
0 to 25% ...................................................................
>25% to 50% ............................................................
>50% to 65% ............................................................
> 65% .......................................................................
Hospital characteristic
TABLE 7—TWO-DOMAIN IMPACT (CLINICAL PROCESS AND HCAHPS): ESTIMATED INCENTIVE RATES BY HOSPITAL CHARACTERISTIC†
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Table 8 below shows the estimated
percent distribution by hospital
characteristic of the 1% reduction ($850
million) in the base operating DRG
payment for fiscal year 2013.
lack the minimum number of cases or
measures required to participate in the
Hospital VBP program. We anticipate
conducting future research on methods
to include small hospitals in the
Hospital VBP program.
TABLE 8—AVERAGE ESTIMATED PERCENTAGE WITHHOLD AMOUNT (AS
REQUIRED BY SECTION 1886(O)(7)
OF THE SOCIAL SECURITY ACT) BY
HOSPITAL CHARACTERISTIC
Hospital characteristic
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Region:
New England .....
Middle Atlantic ...
South Atlantic ....
East North Central ..................
East South Central ..................
West North Central ..................
West South Central ..................
Mountain ............
Pacific ................
Urban/Rural:
Large Urban ......
Other Urban .......
Rural ..................
Capacity (by # beds):
1 to 99 beds ......
100 to 199 beds
200 to 299 beds
300 to 399 beds
400 to 499 beds
500+ beds ..........
Medicare Utilization:
0 to 25% ............
>25 to 50% ........
>50% to 65% .....
>65% .................
N=3,092
Estimated
percent
withhold
amount
138
370
518
5.9
15.9
19.5
475
17.5
301
7.8
248
7.2
457
201
384
10.3
4.8
11.2
1,199
1,010
883
49.8
38.2
11.1
1,045
939
481
279
151
197
8.1
21.2
20.5
16.9
11.0
23.4
237
1,508
1,148
196
3.9
60.0
32.8
3.2
We also analyzed the characteristics
of hospitals not receiving a Hospital
VBP score based on the program
requirements, which is shown below in
Table 9. We estimate that 353 hospitals
will not receive a Hospital VBP score in
fiscal year 2013. We note that these
hospitals will not be impacted by the
reductions in base DRG operating
payments under section 1886(o)(7). IPPS
hospitals not included in this analysis
were excluded due to the complete
absence of cases applicable to the
measures included, or due to the
absence of a sufficient number of cases
to reliably assess the measure.
As might be expected, a significant
portion of hospitals not receiving a
Hospital VBP score are small providers
because such entities are more likely to
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19:34 Jan 12, 2011
TABLE 9—PROJECTED NUMBER OF
HOSPITALS NOT RECEIVING A HOSPITAL VBP SCORE IN FY 2013, BY
HOSPITAL CHARACTERISTIC
Jkt 223001
Hospital characteristic
Number of
hospitals not
receiving hospital VBP
Score
(N=353)
Region:
New England .................
Middle Atlantic ...............
South Atlantic ................
East North Central .........
East South Central ........
West North Central ........
West South Central .......
Mountain ........................
Pacific ............................
Puerto Rico ....................
Missing Region ..............
Urban/Rural:
Large Urban ..................
Other Urban ...................
Rural ..............................
Missing Urban/Rural ......
Capacity (by # beds):
1 to 99 beds ..................
100 to 199 beds ............
200 to 299 beds ............
300 to 399 beds ............
400 to 499 beds ............
500+ beds .....................
Missing Capacity ...........
Medicare Utilization:
0 to 25% ........................
>25% to 50% .................
>50% to 65% .................
>65% .............................
Missing Medicare Utilization .........................
6
18
14
31
26
17
85
25
26
34
71
116
83
83
71
213
47
11
8
2
0
72
78
75
43
28
D. Alternatives considered
The major alternative performance
scoring models considered for this
proposed rule were the Six-Domain
Performance Scoring Model and the
Appropriate Care Model, and both of
Frm 00038
Fmt 4701
Sfmt 4702
E. Accounting Statement
As required by OMB Circular A–4
(available at https://www.whitehouse.
gov/omb/circulars/a004/a-4.pdf), we
have prepared an accounting statement
showing the classification of the
impacts associated with the provisions
of this proposed rule.
As required by section 1886(o)(7)(A),
total reductions for hospitals under
section 1886(o)(7)(B) must be equal to
the amount available for value-based
incentive payments under section
1886(o)(6), resulting in a net budgetneutral impact. Overall, the distributive
impacts of this proposed rule, resulting
from the incentive payments and the
1% reduction (withhold) in the base
operating DRG payment for fiscal year
2013, are estimated at $850 million for
fiscal year 2013 (reflected in 2010
dollars).
TABLE 10—ACCOUNTING STATEMENT:
CLASSIFICATION OF ESTIMATED EXPENDITURES FOR FY 2013
Category
Annualized
Monetized
Transfers.
129
We note that a number of hospitals
were missing hospital characteristic
data, including region, urban/rural
classification, size, and Medicare
utilization. All 353 hospitals included
in Table 9, including those with missing
hospital characteristic data, lacked
sufficient clinical process of care data or
HCAHPS data needed to calculate a
total performance score.
PO 00000
these models were discussed in Section
II. E. of this proposed rule. Examining
these alternative performance scoring
models, our analyses showed only
modest differences in financial
reimbursements across the separate
models considered by the various
characteristics listed above. We believe
that these observed transfers are within
the limits of expected variation and do
not reflect significant differences in
financial reimbursements between the
performance scoring models considered.
From Whom
To Whom?
Transfers
$0 (distributive impacts resulting from the incentive
payments and the 1% reduction (withhold) in the
base operating DRG payment are estimated at
$850 million).
Federal Government to Hospitals.
The analysis above, together with the
remainder of this preamble, provides a
Regulatory Impact Analysis. In
accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
List of Subjects
42 CFR Part 422
Administrative practice and
procedure, Health facilities, Health
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maintenance organizations (HMO),
Medicare, Penalties, Privacy, Reporting
and recordkeeping requirements.
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
42 CFR Part 480
Health care, Health professions,
Health records, Peer Review
Organizations (PRO), Penalties, Privacy,
Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services proposes to amend
42 CFR chapter IV as follows:
Subpart B—Utilization and Quality
Control Quality Improvement
Organizations (QIOs)
PART 422—MEDICARE ADVANTAGE
PROGRAM
1. The authority citation for part 422
continues to read as follows:
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
Subpart D—Quality Improvement
2. Section 422.153 is revised to read
as follows:
§ 422.153 Use of quality improvement
organization review information.
CMS will acquire from quality
improvement organizations (QIOs) as
defined in part 475 of this chapter data
collected under section
1886(b)(3)(B)(viii) of the Act and subject
to the requirements in § 480.140(g).
CMS will acquire this information, as
needed, and may use it for the following
functions:
(a) Enable beneficiaries to compare
health coverage options and select
among them.
(b) Evaluate plan performance.
(c) Ensure compliance with plan
requirements under this part.
(d) Develop payment models.
(e) Other purposes related to MA
plans as specified by CMS.
PART 480—ACQUISITION,
PROTECTION, AND DISCLOSURE OF
QUALITY IMPROVEMENT
ORGANIZATION REVIEW
INFORMATION
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3. The authority citation for part 480
continues to read as follows:
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18:43 Jan 12, 2011
Jkt 223001
4. Section 480.101(b) is amended by
revising the definition of ‘‘QIO review
system’’ to read as follows:
§ 480.101
Scope and definitions.
*
*
*
*
*
QIO review system means the QIO and
those organizations and individuals
who either assist the QIO or are directly
responsible for providing medical care
or for making determinations with
respect to the medical necessity,
appropriate level and quality of health
care services that may be reimbursed
under the Act. The system includes—
(1) The QIO and its officers, members
and employees;
(2) QIO subcontractors;
(3) Health care institutions and
practitioners whose services are
reviewed;
(4) QIO reviewers and supporting
staff;
(5) Data support organizations; and
(6) CMS.
*
*
*
*
*
5. Section 483.130 is revised to read
as follows:
§ 480.130
Disclosure to the Department.
Except as limited by § 480.139(a) and
§ 480.140 of this subpart, QIOs must
disclose to the Department all
information requested by the
Department in the manner and form
requested. The Information can include
confidential and non-confidential
information and requests can include
those made by any component of the
Department, such as CMS.
6. Section 480.139 is amended by
revising paragraph (a)(1) to read as
follows:
§ 480.139 Disclosure of QIO deliberations
and decisions.
(a) QIO deliberations. (1) A QIO must
not disclose its deliberations except to—
(i) CMS; or
PO 00000
Frm 00039
Fmt 4701
Sfmt 9990
2491
(ii) The Office of the Inspector
General, and the General Accounting
Office as necessary to carry out statutory
responsibilities.
*
*
*
*
*
7. Section 480.140 is amended by
revising paragraph (a)(1) and paragraph
(g) to read as follows:
§ 480.140 Disclosure of quality review
study information.
(a) * * *
(1) Representatives of authorized
licensure, accreditation or certification
agencies as is required by the agencies
in carrying out functions which are
within the jurisdiction of such agencies
under state law; to federal and state
agencies responsible for identifying
risks to the public health when there is
substantial risk to the public health; or
to Federal and State fraud and abuse
enforcement agencies;
*
*
*
*
*
(g) A QIO must disclose quality
review study information to CMS with
identifiers of patients, practitioners or
institutions—
(1) For purposes of quality
improvement. Activities include, but are
not limited to, data validation,
measurement, reporting, and evaluation.
(2) As requested by CMS when CMS
deems it necessary for purposes of
overseeing and planning QIO program
activities.
Authority: Catalog of Federal Domestic
Assistance Program No. 93.773, Medicare—
Hospital Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program.
Dated: December 10, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: December 16, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2011–454 Filed 1–7–11; 4:15 pm]
BILLING CODE 4120–01–P
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Agencies
[Federal Register Volume 76, Number 9 (Thursday, January 13, 2011)]
[Proposed Rules]
[Pages 2454-2491]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-454]
[[Page 2453]]
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Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 422 and 480
Medicare Program; Hospital Inpatient Value-Based Purchasing Program;
Proposed Rule
Federal Register / Vol. 76 , No. 9 / Thursday, January 13, 2011 /
Proposed Rules
[[Page 2454]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 422 and 480
[CMS-3239-P]
RIN 0938-AQ55
Medicare Program; Hospital Inpatient Value-Based Purchasing
Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: In this proposed rule, we are proposing to implement a
Hospital Value-Based Purchasing program (``Hospital VBP program'' or
``the program'') under section 1886(o) of the Social Security Act
(``Act''), under which value-based incentive payments will be made in a
fiscal year to hospitals that meet performance standards with respect
to a performance period for the fiscal year involved. The program will
apply to payments for discharges occurring on or after October 1, 2012,
in accordance with section 1886(o) of the Social Security Act (as added
by section 3001(a) of the Patient Protection and Affordable Care Act
(Pub. L. 111-148), enacted on March 23, 2010, as amended by the Health
Care and Education Reconciliation Act of 2010 (Pub. L. 111-152),
enacted on March 30, 2010 (collectively known as the Affordable Care
Act)). The measures we are proposing to initially adopt for the program
are a subset of the measures that we have already adopted for the
existing Medicare Hospital Inpatient Quality Reporting Program
(Hospital IQR program), formerly known as the Reporting Hospital
Quality Data for the Annual Payment Update Program (RHQDAPU), and we
are proposing, based on whether a hospital meets or exceeds the
performance standards that we are proposing to establish with respect
to the measures, to reward the hospital based on its actual
performance, rather than simply its reporting of data for those
measures.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on March 8, 2011.
ADDRESSES: In commenting, please refer to file code CMS-3239-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address only:
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Attention: CMS-3239-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-3239-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) 786-8691 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.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Allison Lee, (410) 786-8691.
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. Overview
B. Hospital Inpatient Quality Data Reporting Under Section
501(b) of Public Law 108-173
C. Hospital Inpatient Quality Reporting Under Section 5001(a) of
Public Law 109-171
D. 2007 Report to Congress: Plan To Implement a Medicare
Hospital Value-Based Purchasing Program
E. Provisions of the Affordable Care Act
II. Provisions of the Proposed Regulations
A. Overview of the Proposed Hospital Value-Based Purchasing
Program
B. Proposed Performance Period
C. Proposed Measures
D. Proposed Performance Standards
E. Proposed Methodology for Calculating the Total Performance
Score
F. Applicability of the Value-Based Purchasing Program to
Hospitals
G. The Exchange Function
H. Proposed Hospital Notification and Review Procedures
I. Proposed Reconsideration and Appeal Procedures
J. Proposed FY 2013 Validation Requirements for Hospital Value-
Based Purchasing
K. Additional Information
L. QIO Quality Data Access
III. Collection of Information Requirements
IV. Response to Comments
V. Regulatory Impact Statement
A. Overall Impact
B. Anticipated Effects
C. Alternatives Considered
D. Accounting Statement
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:
AHRQ Agency for Healthcare Research and Quality
[[Page 2455]]
AMI Acute Myocardial Infarction
CCN CMS Certification number
CMS Centers for Medicare & Medicaid Services
DRG Diagnosis-Related Group
FISMA Federal Information Security and Management Act
HCAHPS Hospital Consumer Assessment of Healthcare Providers and
Systems
HF Heart Failure
HIPAA Health Insurance Portability and Accountability Act
HOP QDRP Hospital Outpatient Quality Data Reporting Program
IPPS Inpatient prospective payment systems
IQR Inpatient Quality Reporting
NQF National Quality Forum
PN Pneumonia
PQRI Physician Quality Reporting Initiative
PRRB Provider Reimbursement Review Board
PSI Patient Safety Indicator
QIO Quality Improvement Organization
QRS Quality Review Study
RFA Regulatory Flexibility Act
RHQDAPU Reporting Hospital Quality Data for the Annual Payment
Update Program
RIA Regulatory Impact Analysis
SCIP Surgical Care Improvement
VBP Value-Based Purchasing
I. Background
A. Overview
The Centers for Medicare & Medicaid Services (CMS) promotes higher
quality and more efficient health care for Medicare beneficiaries. In
recent years, we have undertaken a number of initiatives to lay the
foundation for rewarding health care providers and suppliers for the
quality of care they provide by tying a portion of their Medicare
payments to their performance on quality measures. These initiatives,
which include demonstration projects and quality reporting programs,
have been applied to various health care settings, including
physicians' offices, ambulatory care facilities, hospitals, nursing
homes, home health agencies, and dialysis facilities. The overarching
goal of these initiatives is to transform Medicare from a passive payer
of claims to an active purchaser of quality health care for its
beneficiaries.
This effort is supported by our adoption of an increasing number of
widely-agreed upon quality measures for purposes of our existing
quality reporting programs. We have worked with stakeholders to define
measures of quality in almost every setting. These measures assess
structural aspects of care, clinical processes, patient experiences
with care, and, increasingly, outcomes.
We have implemented quality measure reporting programs that apply
to various settings of care. With regard to hospital inpatient
services, we implemented the Hospital IQR program. In addition, we have
implemented quality reporting programs for hospital outpatient services
through the Hospital Outpatient Quality Data Reporting Program (HOP
QDRP), and for physicians and other eligible professionals through the
Physician Quality Reporting Initiative (PQRI). We have also implemented
quality reporting programs for home health agencies and skilled nursing
facilities based on conditions of participation, and an end-stage renal
disease quality reporting program based on conditions for coverage.
This new program will necessarily be a fluid model, subject to
change as knowledge, measures and tools evolve. We view the Hospital
VBP program under section 1886(o) of the Social Security Act (the Act)
as the next step in promoting higher quality care for Medicare
beneficiaries and transforming Medicare into an active purchaser of
quality health care for its beneficiaries.
In developing this rule as well as other value-based payment
initiatives, CMS applied the following principles for the development
and use of measures and scoring methodologies.
Purpose:
CMS views value-based purchasing as an important step to revamping
how care and services are paid for, moving increasingly toward
rewarding better value, outcomes, and innovations instead of merely
volume.
Use of Measures:
Public reporting and value-based payment systems should
rely on a mix of standards, process, outcomes, and patient experience
measures, including measures of care transitions and changes in patient
functional status. Across all programs, CMS seeks to move as quickly as
possible to the use of primarily outcome and patient experience
measures. To the extent practicable and appropriate, outcomes and
patient experience measures should be adjusted for risk or other
appropriate patient population or provider characteristics.
To the extent possible and recognizing differences in
payment system maturity and statutory authorities, measures should be
aligned across Medicare's and Medicaid's public reporting and payment
systems. CMS seeks to evolve to a focused core-set of measures
appropriate to the specific provider category that reflects the level
of care and the most important areas of service and measures for that
provider.
The collection of information should minimize the burden
on providers to the extent possible. As part of that effort, CMS will
continuously seek to align its measures with the adoption of meaningful
use standards for health information technology (HIT), so the
collection of performance information is part of care delivery.
To the extent practicable, measures used by CMS should be
nationally endorsed by a multi-stakeholder organization. Measures
should be aligned with best practices among other payers and the needs
of the end users of the measures.
Scoring Methodology:
Providers should be scored on their overall achievement
relative to national or other appropriate benchmarks. In addition,
scoring methodologies should consider improvement as an independent
goal.
Measures or measurement domains need not be given equal
weight, but over time, scoring methodologies should be more weighted
towards outcome, patient experience and functional status measures.
Scoring methodologies should be reliable, as
straightforward as possible, and stable over time and enable consumers,
providers, and payers to make meaningful distinctions among providers'
performance.
CMS welcomes comments on these principles.
B. Hospital Inpatient Quality Data Reporting Under Section 501(b) of
Public Law 108-173
Section 501(b) of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA), Public Law 108-173, added section
1886(b)(3)(B)(vii) to the Act. This section established the original
authority for the Hospital IQR program and revised the mechanism used
to update the standardized payment amount for inpatient hospital
operating costs. Specifically, section 1886(b)(3)(B)(vii)(I) of the Act
provided for a reduction of 0.4 percentage points to the annual
percentage increase (sometimes referred to at that time as the market
basket update) for FY 2005 through FY 2007 for a subsection (d)
hospital if the hospital did not submit data on a set of 10 quality
indicators established by the Secretary as of November 1, 2003. It also
provided that any reduction applied only to the fiscal year involved,
and would not be taken into account in computing the applicable
percentage increase for a subsequent fiscal year. The statute thereby
established an incentive for many subsection (d) hospitals to submit
data on the quality measures established by the Secretary.
We implemented section 1886(b)(3)(B)(vii) of the Act in the FY
[[Page 2456]]
2005 IPPS final rule (69 FR 49078) and codified the applicable
percentage change in Sec. 412.64(d) of our regulations. We adopted
additional requirements under the Hospital IQR program in the FY 2006
IPPS final rule (70 FR 47420).
C. Hospital Inpatient Quality Reporting Under Section 5001(a) of Public
Law 109-171
1. Change in the Reduction to the Annual Percentage Increase
Section 5001(a) of the Deficit Reduction Act of 2005 (DRA), Public
Law 109-171, further amended section 1886(b)(3)(B) of the Act to, among
other things, revise the mechanism used to update the standardized
payment amount for hospital inpatient operating costs by adding new
section 1886(b)(3)(B)(viii) to the Act. Specifically, sections
1886(b)(3)(B)(viii)(I) and (II) of the Act as added by the DRA
originally provided that the annual percentage increase for FY 2007 and
each subsequent fiscal year shall be reduced by 2.0 percentage points
for a subsection (d) hospital that does not submit quality data in a
form and manner, and at a time, specified by the Secretary. Section
1886(b)(3)(B)(viii)(I) of the Act also provided that any reduction in a
hospital's annual percentage increase will apply only with respect to
the fiscal year involved, and will not be taken into account for
computing the applicable percentage increase for a subsequent fiscal
year.
In the FY 2007 IPPS final rule (71 FR 48045), we amended our
regulations at Sec. 412.64(d)(2) to reflect the 2.0 percentage point
reduction required under the DRA.
2. Selection of Quality Measures
Section 1886(b)(3)(B)(viii)(V) of the Act, before it was amended by
section 3001(a)(2)(B) of the Affordable Care Act, required that,
effective for payments beginning with FY 2008, the Secretary add other
measures that reflect consensus among affected parties, and to the
extent feasible and practicable, have been set forth by one or more
national consensus building entities. The National Quality Forum (NQF)
is a voluntary consensus standard-setting organization with a diverse
representation of consumer, purchaser, provider, academic, clinical,
and other health care stakeholder organizations. The NQF was
established to standardize health care quality measurement and
reporting through its consensus development process. We have generally
adopted NQF-endorsed measures for purposes of the Hospital IQR program.
However, we believe that consensus among affected parties also can be
reflected by other means, including consensus achieved during the
measure development process, consensus shown through broad acceptance
and use of measures, and consensus achieved through public comment.
Section 1886(b)(3)(B)(viii)(VI) of the Act authorizes the Secretary
to replace any quality measures or indicators in appropriate cases,
such as when all hospitals are effectively in compliance with a
measure, or the measures or indicators have been subsequently shown to
not represent the best clinical practice. We interpreted this provision
to give us broad discretion to replace measures that are no longer
appropriate for the Hospital IQR program.
We have adopted 45 measures under the Hospital IQR program for the
FY 2011 payment determination. Of these measures, 27 are chart-
abstracted process of care measures, which assess the quality of care
furnished by hospitals in connection with four topics: Acute Myocardial
Infarction (AMI); Heart Failure (HF); Pneumonia (PN); and Surgical Care
Improvement (SCIP) (75 FR 50182). Fifteen of the measures are claims-
based measures, which assess the quality of care furnished by hospitals
on the following topics: 30-day mortality and 30-day readmission rates
for Medicare patients diagnosed with either AMI, HF, or PN; Patient
Safety Indicators/Inpatient Quality Indicators/Composite Measures; and
Patient Safety Indicators/Nursing Sensitive Care. Three of the measures
are structural measures that assess hospital participation in cardiac
surgery, stroke care, and nursing sensitive care systemic databases.
Finally, the Hospital Consumer Assessment of Healthcare Providers and
Systems (HCAHPS) patient experience of care survey is included as a
measure for the FY 2011 payment determination.
The technical specifications for the Hospital IQR program measures,
or links to Web sites hosting technical specifications, are contained
in the CMS/The Joint Commission Specifications Manual for National
Hospital Inpatient Quality Measures (Specifications Manual). This
Specifications Manual is posted on the CMS QualityNet Web site at
https://www.QualityNet.org/. We maintain the technical specifications
by updating this Specifications Manual semiannually, or more frequently
in unusual cases, and include detailed instructions and calculation
algorithms for hospitals to use when collecting and submitting data on
required measures. These semiannual updates are accompanied by
notifications to users, providing sufficient time between the change
and the effective date in order to allow users to incorporate changes
and updates to the specifications into data collection systems.
3. Public Display of Quality Measures
Section 1886(b)(3)(B)(viii)(VII) of the Act, before it was amended
by section 3001(a)(2)(C) of the Affordable Care Act, required that the
Secretary establish procedures for making data submitted under the
Hospital IQR program available to the public after ensuring that a
hospital has the opportunity to review the data before it is made
public. To meet this requirement, we have displayed most Hospital IQR
program data on the Hospital Compare website, https://www.hospitalcompare.hhs.gov, after a 30-day preview period. An
interactive Web tool, this Web site assists beneficiaries by providing
information on hospital quality of care to those who need to select a
hospital. It further serves to encourage beneficiaries to work with
their doctors and hospitals to discuss the quality of care hospitals
provide to patients, thereby providing an additional incentive to
hospitals to improve the quality of care that they furnish. The
Hospital Compare website currently makes public data on clinical
process of care measures, risk adjusted outcome measures, the HCAHPS
patient experience of care survey, and structural measures. However,
data that we believe is not suitable for inclusion on Hospital Compare
because it is not salient or will not be fully understood by
beneficiaries, as well as data for which there are unresolved display
or design issues may be made available on other CMS Web sites that are
not intended to be used as an interactive Web tool, such as https://www.cms.hhs.gov/HospitalQualityInits/. In such circumstances, affected
parties are notified via CMS listservs, CMS e-mail blasts, national
provider calls, and QualityNet announcements regarding the release of
preview reports followed by the posting of data on a Web site other
than Hospital Compare.
D. 2007 Report to Congress: Plan To Implement a Medicare Hospital
Value-Based Purchasing Program
Section 5001(b) of the DRA required the Secretary to develop a plan
to implement a value-based purchasing program for payments made under
the Medicare program for subsection (d) hospitals. In developing the
plan, we were required to consider the on-going development, selection,
and modification process for measures of
[[Page 2457]]
quality and efficiency in hospital inpatient settings; the reporting,
collection, and validation of quality data; the structure, size, and
sources of funding of value-based payment adjustments; and the
disclosure of information on hospital performance.
In 2007, we submitted to Congress a report that discusses options
for a plan to implement a Medicare hospital VBP program that builds on
the Hospital IQR program. We recommended replacing the Hospital IQR
program with a new program that would include both a public reporting
requirement and financial incentives for better performance. We also
recommended that a hospital VBP program be implemented in a manner that
would not increase Medicare spending.
To calculate a hospital's total performance score under the plan,
we analyzed a potential performance scoring model that incorporated
measures from different quality ``domains,'' including clinical process
of care and patient experience of care. We examined ways to translate
that score into an incentive payment by making a portion of the base
diagnosis-related group (DRG) payment contingent on performance. We
analyzed criteria for selecting performance measures and considered a
potential phased approach to transition from Hospital IQR to value-
based purchasing. In addition, we examined redesigning the current data
transmission process and validation infrastructure, including making
enhancements to the Hospital Compare Web site, as well as an approach
to monitor the impact of value-based purchasing.
E. Provisions of the Affordable Care Act
Section 3001(a) of the Patient Protection and Affordable Care Act
(Pub. L. 111-148), enacted on March 23, 2010, as amended by the Health
Care and Education Reconciliation Act of 2010 (Pub. L. 111-152),
enacted on March 30, 2010 (collectively known as the Affordable Care
Act), added a new section 1886(o) to the Social Security Act (the Act)
which requires the Secretary to establish a hospital value-based
purchasing program under which value-based incentive payments are made
in a fiscal year to hospitals meeting performance standards established
for a performance period for such fiscal year. Both the performance
standards and the performance period for a fiscal year are to be
established by the Secretary. Section 1886(o)(1)(B) of the Act directs
the Secretary to begin making value-based incentive payments under the
Hospital VBP program to hospitals for discharges occurring on or after
October 1, 2012. These incentive payments will be funded for FY 2013
through a reduction to FY 2013 base operating DRG payments for each
discharge of 1%, as required by section 1886(o)(7). Section
1886(o)(1)(C) provides that the Hospital VBP program applies to
subsection (d) hospitals (as defined in section 1886(d)(1)(B)), but
excludes from the definition of the term ``hospital,'' with respect to
a fiscal year: 1) a hospital that is subject to the payment reduction
under section 1886(b)(3)(B)(viii)(I) for such fiscal year; 2) a
hospital for which, during the performance period for the fiscal year,
the Secretary cited deficiencies that pose immediate jeopardy to the
health and safety of patients; and 3) a hospital for which there is not
a minimum number (as determined by the Secretary) of applicable
measures for the performance period for the fiscal year involved, or
for which there is not a minimum number (as determined by the
Secretary) of cases for the applicable measures for the performance
period for such fiscal year.
II. Provisions of the Proposed Regulations
A. Overview of the Proposed Hospital VBP Program
This proposed rule proposes to implement a Hospital Value-Based
Purchasing program (``Hospital VBP program'' or ``the program'') under
section 1886(o) of the Social Security Act (``Act''), under which
value-based incentive payments will be made in a fiscal year (beginning
FY 2013) to hospitals that meet performance standards established with
respect to a performance period ending prior to the beginning of such
fiscal year. This proposed rule was developed based on extensive
research we conducted on hospital value-based purchasing, including
research that formed the basis of a 2007 report we submitted to
Congress, entitled ``Report to Congress: Plan to Implement a Medicare
Hospital Value-Based Purchasing Program'' (November 21, 2007), a copy
of which is available on the CMS Web site, and takes into account input
from both stakeholders and other interested parties. As described more
fully below, we are proposing to initially adopt for the FY 2013
Hospital VBP program 18 measures that we have already adopted for the
Hospital IQR Program, categorized into two domains, as follows: 17 of
the proposed measures will be clinical process of care measures, which
we will group into a clinical process of care domain, and 1 measure
will be the HCAHPS survey, which will fall under a patient experience
of care domain. With respect to the clinical process of care and HCAHPS
measures, we are proposing to use a three-quarter performance period
from July 1, 2011 through March 31, 2012 for the FY 2013 payment
determination and to determine whether hospitals meet the proposed
performance standards for these measures by comparing their performance
during the proposed performance period to their performance during a
proposed three-quarter baseline period from July 1, 2009 through March
31, 2010. We are also proposing to initially adopt for the FY 2014
Hospital VBP program three outcome measures. With respect to the
proposed outcome measures, we are proposing to use an 18-month
performance period from July 1, 2011 to December 31, 2012. Furthermore,
for the proposed outcome measures, we are proposing to establish
performance standards and to determine whether hospitals meet those
standards by comparing their performance during the proposed
performance period to their performance during a proposed baseline
period of July 1, 2008 to December 31, 2009.
In general, we are proposing to implement a methodology for
assessing the total performance of each hospital based on performance
standards, under which we will score each hospital based on achievement
and improvement ranges for each applicable measure. Additionally, we
are proposing to calculate a total performance score for each hospital
by combining the greater of the hospital's achievement or improvement
points for each measure to determine a score for each domain,
multiplying each domain score by a proposed weight (clinical process of
care: 70 percent, patient experience of care: 30 percent), and adding
together the weighted domain scores. We are proposing to convert each
hospital's total performance score into a value-based incentive payment
utilizing a linear exchange function. All of these proposals are
addressed in greater detail below.
B. Proposed Performance Period
Section 1886(o)(4) of the Act requires the Secretary to establish a
performance period for a fiscal year that begins and ends prior to the
beginning of such fiscal year. In considering various performance
periods that could apply for purposes of the fiscal year 2013 payment
adjustments, we recognized that hospitals submit data on the chart-
abstracted measures adopted for the Hospital IQR Program on a quarterly
[[Page 2458]]
basis, and for that reason, we would propose that the performance
period commence at the beginning of a quarter. We also recognize that
we must balance the length of the period for collecting measure data
with the need to undertake the rulemaking process in order to establish
the performance period and provide the public with an opportunity to
meaningfully comment on that proposal. With these considerations in
mind, we concluded that July 1, 2011 is the earliest date that the
performance period could begin.
We then considered how long the performance period should be. Our
preference would have been to propose to use a full year as the
performance period for the clinical process of care and HCAHPS measures
we are proposing to initially adopt for the FY 2013 Hospital VBP
program, consistent with our analysis that using a full year
performance period provides high levels of data accuracy and
reliability for scoring hospitals on these measures. We concluded,
however, that this would not give us sufficient time to calculate the
total performance scores, calculate the value-based incentive payments,
notify hospitals regarding their payment adjustments, and implement the
payment adjustments. We subsequently analyzed how a shorter performance
period might affect a hospital's performance score. Using the most
recent clinical process of care and HCAHPS measure data available, we
examined the feasibility of proposing to adopt a one quarter, two
quarter, or three quarter performance period by comparing each of these
periods to a four quarter baseline period. We did this to determine how
closely a hospital's total performance score calculated using one, two,
or three quarters of data would approximate what the hospital's total
performance score would be if we proposed to use four quarters of data.
Under our analysis, the total performance scores approximated using
three quarters of data closely correlated with total performance scores
approximated using four quarters of data. Specifically, our analysis
showed that the three quarter performance period would have a
correlation coefficient of 0.96815 (p-value .0001), while a two quarter
performance period would have a correlation coefficient of 0.90358 (p-
value .0001).
We also recognize that under the Hospital IQR program, hospitals
have 135 days to submit chart abstracted data following the close of
each quarter. Because we are proposing to implement a Hospital VBP
program that builds on the Hospital IQR program, we would like, to the
extent possible, to maintain our existing Hospital IQR program
requirements. We believe that the 135 day time lag supports the
adoption of a three quarter performance period based on the analysis
discussed above, and that a one or two quarter performance period would
provide lower data accuracy for scoring hospitals and adjusting their
payments.
Therefore, we propose to use the fourth quarter of FY 2011 (July 1,
2011-September 30, 2011) and the first and second quarters of FY 2012
(October 1, 2011-March 31, 2012) as the performance period for proposed
clinical process of care and HCAHPS measures we are proposing to
initially adopt for the FY 2013 Hospital VBP program. Hospitals will be
scored based on how well they perform on the proposed clinical process
of care and HCAHPS measures during this proposed performance period. We
note that we anticipate proposing to use a full year as the performance
period for the clinical process of care and HCAHPS measures in the
future. For the three mortality outcome measures currently specified
for the Hospital IQR program for the FY 2011 payment determination
(MORT-30-AMI, MORT-30-HF, MORT-30-PN) that we propose below to adopt
for the FY 2014 Hospital VBP program payment determination, we are
proposing to establish a performance period of July 1, 2011 to December
31, 2012. An eighteen-month performance period for mortality measures
is intended to ensure the measures' reliability by capturing more cases
than could be observed over one year of measurement. We plan to add
additional measures to the Hospital VBP program, including but not
limited to AHRQ and HAC measures that have been specified for the
Hospital IQR program and propose that the performance period for those
measures will begin one year after these measures have been displayed
on the Hospital Compare Web site for the reasons discussed below.
C. Proposed Measures
Section 1886(o)(2)(A) of the Act requires the Secretary to select
for the Hospital VBP program measures, other than readmission measures,
from the measures specified for the Hospital IQR program. Section
1886(o)(2)(B)(i) requires the Secretary to ensure that the selected
measures include measures on six specified conditions or topics: Acute
Myocardial Infarction (AMI); Heart Failure (HF); Pneumonia (PN);
Surgeries, as measured by the Surgical Care Improvement Project (SCIP);
Healthcare-Associated Infections (HAI); and, the Hospital Consumer
Assessment of Healthcare Providers and Systems survey (HCAHPS). Section
1886(o)(2)(C)(i) provides that the Secretary may not select a measure
with respect to a performance period for a fiscal year unless the
measure has been specified under section 1886(b)(3)(B)(viii) of the Act
and included on the Hospital Compare website for at least one year
prior to the beginning of the performance period. Section
1886(o)(2)(C)(ii) provides that a measure selected under section
1886(o)(2)(A) shall not apply to a hospital if the hospital does not
furnish services appropriate to the measure.
Our measure development and selection activities for the Hospital
IQR Program take into account national priorities, such as those
established by the National Priorities Partnership,\1\ and the
Department of Health and Human Services,\2\ as well as other widely
accepted criteria established in medical literature.\3\ Because we must
select measures for the Hospital VBP program from the pool of measures
that have been adopted for the Hospital IQR program, the measures to be
selected for inclusion in Hospital VBP would also reflect these
priorities.
---------------------------------------------------------------------------
\1\ https://www.nationalprioritiespartnership.org/.
\2\ https://www.hhs.gov/secretary/about/priorities/priorities.html.
\3\ Chassin, M.R.; Loeb, J.M.; Schmaltz, S.P. and Wachter, R.M.
(2010) ``Accountability Measures--Using Measurement to Promote
Quality Improvement.'' New England Journal of Medicine. Vol 363:
683-688.
---------------------------------------------------------------------------
In the FY 2011 IPPS/RY 2011 LTCH PPS final rule, we stated that in
future expansions and updates to the Hospital IQR program measure set,
we would be taking into consideration several important goals. These
goals include: (a) Expanding the types of measures beyond process of
care measures to include an increased number of outcome measures,
efficiency measures, and patients' experience of care measures; (b)
expanding the scope of hospital services to which the measures apply;
(c) considering the burden on hospitals in collecting chart-abstracted
data; (d) harmonizing the measures used in the Hospital IQR program
with other CMS quality programs to align incentives and promote
coordinated efforts to improve quality; (e) seeking to use measures
based on alternative sources of data that do not require chart
abstraction or that utilize data already being reported by many
hospitals, such as data that hospitals report to clinical data
registries, or all payer claims databases; and (f) weighing the
relevance and utility of the measures compared to the burden on
hospitals in submitting data under the Hospital IQR program. In
addition, we believe that we
[[Page 2459]]
must act with all speed and deliberateness to expand the pool of
measures used in the Hospital VBP program. This goal is supported by at
least two Federal reports documenting that tens of thousands of
patients do not receive safe care in the nation's hospitals.\4\ For
this reason, we believe that we need to adopt measures for the Hospital
VBP program relevant to improving care, particularly as these measures
are directed toward improving patient safety, as quickly as possible.
We believe that speed of implementation is a critical factor in the
success and effectiveness of this program.
---------------------------------------------------------------------------
\4\ See OEI-06-09-00090 ``Adverse Events in Hospitals: National
Incidence Among Medicare Beneficiaries.'' Department of Health and
Human Services, Office of Inspector General, November 2010. See
also, 2009 National Healthcare Quality Report, pp. 107-122.
``Patient Safety,'' Agency for Healthcare Research and Quality.
---------------------------------------------------------------------------
The Hospital VBP program that we are proposing to implement has
been developed with the focused intention to motivate all subsection
(d) hospitals to which the program applies to take immediate action to
improve the quality of care they furnish to their patients. Because we
view as urgent the necessity to improve the quality of care furnished
by these hospitals, and because we believe that hospitalized patients
in the United States currently face patient safety risks on a daily
basis, we are proposing in this proposed rule to adopt an initial
measure set for the Hospital VBP program. However, we are also
proposing to add additional measures to the Hospital VBP program in the
future in such a way that their performance period will begin
immediately after they are displayed on Hospital Compare for a period
of time of at least one year, but without the necessity of notice and
comment rulemaking. We propose this because of the urgency to improve
the quality of hospital care, and in order to minimize any delay to
take substantive action in favor of patient safety. The details of this
proposal are discussed below.
We have stated that for the Hospital IQR Program, we give priority
to quality measures that assess performance on: (a) Conditions that
result in the greatest mortality and morbidity in the Medicare
population; (b) conditions that are high volume and high cost for the
Medicare program; and (c) conditions for which wide cost and treatment
variations have been reported, despite established clinical guidelines.
In addition, we stated that we seek to select measures that address the
six quality aims of effective, safe, timely, efficient, patient-
centered, and equitable healthcare. Current and long term priority
topics include: Prevention and population health; safety; chronic
conditions; high cost and high volume conditions; elimination of health
disparities; healthcare-associated infections and other adverse
healthcare outcomes; improved care coordination; improved efficiency;
improved patient and family experience of care; effective management of
acute and chronic episodes of care; reduced unwarranted geographic
variation in quality and efficiency; and adoption and use of
interoperable health information technology.
We have also stated that these criteria, priorities, and goals are
consistent with section 1886(b)(3)(B)(viii)(X) of the Act, as added by
section 3001(a)(2)(D) of the Affordable Care Act, which requires the
Secretary, to the extent practicable and with input from consensus
organizations and other stakeholders, to take steps to ensure that the
Hospital IQR program measures are coordinated and aligned with quality
measures applicable to physicians and other providers of services and
suppliers under Medicare.
Currently, there are 45 measures specified under the Hospital IQR
program for the FY 2011 payment determination. We view all of these
measures (with the exception of the measures of readmission) as
``candidate measures'' for the Hospital VBP program. We recognize that
we cannot add any measure to the program unless it meets the
requirements of section 1886(o). In determining what measures to
initially propose for the FY 2013 Hospital VBP program we considered
several factors. First, a measure must be included on the Hospital
Compare Web site for at least one year prior to the beginning of the
performance period and specified under the Hospital IQR program. The
SCIP-Inf-9 and 10 measures do not meet this requirement nor do any of
the nine (previously ten given the Nursing Sensitive Care--Failure to
Rescue measure was harmonized with the Death Among Surgical Patients
with Serious, treatable Complications) Agency for Healthcare Research
and Quality (AHRQ) measures. Therefore, these measures were not
considered candidate measures. It is our intention to add measures to
the Hospital VBP program as soon as this requirement is met in order to
help improve patient care as quickly as possible.
As noted above, we recognize that we cannot include in the measure
set any readmission measures in accordance with section 1886(o)(2)(A)
of the Act. We also are not proposing at this time to adopt the current
Hospital IQR structural measures because we believe that these measures
require further development if they are to be used for the Hospital VBP
program. We seek public comment at this time on the possible utility of
adopting structural measures for the Hospital VBP program measure set
and how these measures might contribute to the improvement of patient
safety and quality of care. Table 1 contains a list of the remaining
initial eligible measures.
Table 1--Initial Eligible Measures for the FY 2013 Hospital VBP Program
------------------------------------------------------------------------
Measure ID Measure description
------------------------------------------------------------------------
Process Measures
------------------------------------------------------------------------
AMI-1............................. Aspirin at Arrival.
AMI-2............................. Aspirin Prescribed at Discharge.
AMI-3............................. ACE/ARB Inhibitor.
AMI-4............................. Adult Smoking Cessation Advice/
Counseling.
AMI-5............................. Beta Blocker Prescribed at
Discharge.
AMI-7a............................ Fibrinolytic Therapy Received Within
30 Minutes of Hospital Arrival.
AMI-8a............................ Primary PCI Received Within 90
Minutes of Hospital Arrival.
HF-1.............................. Discharge Instructions.
HF-2.............................. Evaluation of LVS Function.
HF-3.............................. ACEI or ARB for LVSD.
HF-4.............................. Adult Smoking Cessation Advice/
Counseling.
[[Page 2460]]
PN-2.............................. Pneumococcal Vaccination.
PN-3b............................. Blood Cultures Performed in the
Emergency Department Prior to
Initial Antibiotic Received in
Hospital.
PN-4.............................. Adult Smoking Cessation Advice/
Counseling.
PN-5c............................. Timing of Receipt of Initial
Antibiotic Following Hospital
Arrival.
PN-6.............................. Initial Antibiotic Selection for CAP
in Immunocompetent Patient.
PN-7.............................. Influenza Vaccination.
SCIP-Inf-1........................ Prophylactic Antibiotic Received
Within One Hour Prior to Surgical
Incision.
SCIP-Inf-2........................ Prophylactic Antibiotic Selection
for Surgical Patients.
SCIP-Inf-3........................ Prophylactic Antibiotics
Discontinued Within 24 Hours After
Surgery End Time.
SCIP-Inf-4........................ Cardiac Surgery Patients with
Controlled 6AM Postoperative Serum
Glucose.
SCIP-Inf-6........................ Surgery Patients with Appropriate
Hair Removal.
SCIP-Card-2....................... Surgery Patients on a Beta Blocker
Prior to Arrival That Received a
Beta Blocker During the
Perioperative Period.
SCIP-VTE-1........................ Surgery Patients with Recommended
Venous Thromboembolism Prophylaxis
Ordered.
SCIP-VTE-2........................ Surgery Patients Who Received
Appropriate Venous Thromboembolism
Prophylaxis Within 24 Hours Prior
to Surgery to 24 Hours After
Surgery.
------------------------------------------------------------------------
Outcome Measures
------------------------------------------------------------------------
MORT-30-AMI....................... Acute Myocardial Infarction (AMI) 30-
Day Mortality Rate.
MORT-30-HF........................ Heart Failure (HF) 30-Day Mortality
Rate.
MORT-30-PN........................ Pneumonia (PN) 30-Day Mortality
Rate.
------------------------------------------------------------------------
Survey Measures
------------------------------------------------------------------------
HCAHPS............................ Hospital Consumer Assessment of
Healthcare Providers and Systems
Survey.
------------------------------------------------------------------------
To determine which measures we would propose to initially adopt for
the FY 2013 Hospital VBP program, we then examined whether any of the
eligible Hospital IQR measures (table above) should be excluded from
the Hospital VBP program measure set because hospital performance on
them is ``topped out,'' meaning that all but a few hospitals have
achieved a similarly high level of performance on them. We believe that
measuring hospital performance on topped-out measures will have no
meaningful effect on a hospital's total performance score. Scoring a
topped-out measure for purposes of the Hospital VBP program would also
present a number of challenges. First, as we discuss below, we are
proposing that the benchmark performance standard for all measures will
be the performance at the mean of the top decile (defined in section
II. E. of this proposed rule). Applied to a topped-out measure, the
benchmark would be statistically indistinguishable from the highest
attainable score for the measure and, in our view, could lead to
unintended consequences as hospitals strive to meet the benchmark.
Examples of unintended consequences could include, but are not limited
to, inappropriate delivery of a service to some patients (such as
delivery of antibiotics to patients without a confirmed diagnosis of
pneumonia), unduly conservative decisions on whether to exclude some
patients from the measure denominator, and a focus on meeting the
benchmark at the expense of actual improvements in quality or patient
outcomes. Second, we have found that for topped-out measures, it is
significantly more difficult to differentiate among hospitals
performing above the median. Third, because a measure cannot be applied
to a hospital unless the hospital furnishes services appropriate to the
measure, data reporting under the Hospital VBP program will not be the
same for all hospitals. To the extent that a hospital can report a
higher proportion of topped-out measures, for which its scores would
likely be high, we believe that such a hospital would be unfairly
advantaged in the determination of its total performance score.
To determine whether an eligible Hospital IQR measure is topped
out, we initially focused on the top distribution of hospital
performance on each measure and noted if their 75th and 90th
percentiles were statistically indistinguishable. Based on our
analysis, we identified 7 topped-out measures: AMI-1 Aspirin at
Arrival; AMI-5 Beta Blocker at Discharge; AMI-3 ACEI or ARB at
Discharge; AMI-4 Smoking Cessation; HF-4 Smoking Cessation; PN-4
Smoking Cessation; and SCIP-Inf-6 Surgery Patients with Appropriate
Hair Removal. We then observed that two of these measures identified as
topped out (AMI-3 ACEI or ARB at Discharge and HF-4 Smoking Cessation)
had significantly lower mean scores than the others, which led us to
question whether our analysis was too focused on the top ends of
distributions and whether additional criteria that could account for
the entire distribution might be more appropriate. To address this, we
analyzed the truncated coefficient of variation for each of the
measures. The coefficient of variation (CV) is a common statistic that
expresses the standard deviation as a percentage of the sample mean in
a way that is independent of the units of observation. Applied to this
analysis, a large CV would indicate a broad distribution of individual
hospital scores, with large and presumably meaningful differences
between hospitals in relative performance. A small CV would indicate
that the distribution of individual hospital scores is clustered
tightly around the mean value, suggesting that it is not useful to draw
distinctions between individual hospital performance scores. We used a
modified version of the CV, namely a truncated CV, for each measure, in
which the five percent of hospitals with the lowest scores, and the
five percent of hospitals with highest scores were first truncated (set
aside) before calculating the CV. This was done to avoid undue effects
of the highest and lowest outlier hospitals, which if included, would
tend to greatly widen the dispersion of the distribution and make the
measure appear to be more reliable or discerning. For example, a
measure for which most hospital scores are tightly clustered
[[Page 2461]]
around the mean value (a small CV) might actually reflect a more robust
dispersion if there were also a number of hospitals with extreme
outlier values, which would greatly increase the perceived variance in
the measure. Accordingly, the truncated CV was added as an additional
criterion requiring that a topped-out measure also exhibit a truncated
CV < 0.10. Using both the truncated CV and data showing whether
hospital performance at the 75th and 90th percentiles was statistically
indistinguishable, we reexamined the available measures and determined
that the same seven measures continue to meet our proposed definition
for being topped-out.
Our priorities for the Hospital VBP program are to transform how
Medicare pays for care and to encourage hospitals to continually
improve the quality of care they furnish. Our analysis of the impact of
including the topped-out measures discussed above shows that their use
would mask true performance differences among hospitals and, as a
result, would fail to advance these priorities. Therefore, we are
proposing to not include these 7 topped-out measures (AMI-1 Aspirin at
Arrival; AMI-5 Beta Blocker at Discharge; AMI-3 ACEI or ARB at
Discharge; AMI-4 Smoking Cessation; HF-4 Smoking Cessation; PN-4
Smoking Cessation; and SCIP-Inf-6 Surgery Patients with Appropriate
Hair Removal) in the list of measures we are proposing to initially
adopt for the FY 2013 Hospital VBP program.
We examined whether the following outcome measures adopted for the
Hospital IQR program are appropriate for inclusion in the FY 2013
Hospital VBP program. These measures are as follows: (1) AHRQ patient
safety indicators (PSIs), inpatient quality indicators (IQIs) and
composite measures; (2) AHRQ PSI and nursing sensitive care measure;
and (3) AMI, HF, and PN mortality measures (Medicare patients). We
believe that these outcome measures provide important information
relating to treatment outcomes and patient safety. We also believe that
adding these outcome measures would significantly improve the
correlation between patient outcomes and Hospital VBP performance.
However, because under section 1886(o)(2)(C)(i) of the Act, we may only
select measures if they have been included on the Hospital Compare
Internet website for a least one year prior to the beginning of the
performance period, we believe that the AHRQ Patient Safety Indicators
(PSI) and Inpatient Quality Indicators (IQI) and composite measures,
and the AHRQ Nursing Sensitive Care measure are not yet eligible for
inclusion in the FY 2013 Hospital VBP program. These measures are
currently specified for the Hospital IQR program but have not yet been
included on Hospital Compare. Because of the urgency to act quickly to
improve patient safety, we plan to adopt them for use in the Hospital
VBP Program as rapidly as possible and will continue working to develop
additional robust outcome measures for the Hospital VBP program. We
invite comments on the addition of the AHRQ PSI, IQI, and Nursing
Sensitive Care measures for Hospital VBP program inclusion in FY 2014
and future years.
We considered whether the current publicly-reported 30-day
mortality claims-based measures (Mort-30-AMI, Mort-30-HF, Mort-30-PN)
should be included in the FY 2013 Hospital VBP program. The mortality
measures assess hospital-specific, risk-standardized, all-cause 30-day
mortality rates for patients hospitalized with a principal diagnosis of
heart attack, heart failure, and pneumonia. All-cause mortality is
defined for purposes of these measures as death from any cause within
30 days after the index admission date, regardless of whether the
patient died while still in the hospital or after discharge. On July 1,
2009, the specifications for these measures were changed from a one-
year reporting period to a three-year rolling average. This was done to
address concerns regarding the reliability of the measures, and the
three-year rolling average allows us to include a larger number of
cases in the measure calculations, although our analysis shows that
eighteen months of these data is also reliable. We do not believe that
the three-quarter performance period we are proposing to use for the
initial clinical process of care and HCAHPS measures for the FY 2013
Hospital VBP program would be appropriate to use for these mortality
outcome measures because we do not believe that the data collected for
these mortality measures during those three quarters will provide us
with sufficiently accurate information about a hospital's outcomes on
which to score hospitals on these measures and base payment. The
detailed methodology for the 30-day risk standardized mortality
measures is available on https://www.qualitynet.org.
However, we propose to adopt these currently reported 30-day
mortality claims-based measures (MORT-30-AMI, MORT-30-HF, and MORT-30-
PN) as measures for the FY 2014 Hospital VBP program and, as proposed
above, to establish a performance period with respect to these measures
of July 1, 2011 to December 31, 2012.
The eligible clinical process of care measures that have not been
excluded for reasons previously discussed cover acute myocardial
infarction, heart failure, pneumonia, and surgeries (as measured by the
Surgical Care Improvement Project (SCIP)). Therefore, we believe that
they meet the requirements in section 1886(o)(2)(B)(i)(I)(aa)-(dd) of
the Act. Section 1886(o)(2)(B)(i)(ee) of the Act requires the Secretary
to also select for purposes of the FY 2013 Hospital VBP program
measures that cover healthcare-associated infections (HAI) ``as
measured by the prevention metrics and targets established in the HHS
Action Plan to Prevent Healthcare-Associated Infections (or any
successor plan) of the Department of Health and Human Services.'' The
SCIP measures that we discuss above were developed to support practices
that have demonstrated an ability to significantly reduce surgical
complications such as HAIs. Compliance with these SCIP infection
measures is also included as a targeted metric in the HHS Action Plan
to Prevent Healthcare-Associated Infections issued in 2009, available
on the HHS website. As a result, we believe that the SCIP-Inf-1; SCIP-
Inf-2; SCIP-Inf-3; and SCIP-Inf-4 measures we have adopted for the
Hospital IQR program meet the requirement in section
1886(o)(2)(B)(i)(I)(ee) and we propose to categorize them under a HAI
condition topic instead of under the SCIP condition topic.
Under section 1886(o)(2)(B)(i)(II), the Secretary must select
measures for the FY 2013 Hospital VBP program related to the Hospital
Consumer Assessment of Healthcare Providers and Systems survey
(HCAHPS). CMS partnered with the Agency for Healthcare Research and
Quality (AHRQ) to develop HCAHPS. The HCAHPS survey is the first
national, standardized, publicly reported survey of patients'
experiences of hospital care, and we propose to adopt it for the FY
2013 Hospital VBP program. HCAHPS, also known as the CAHPS[supreg]
Hospital Survey, is a survey instrument and data collection methodology
for measuring patients' perceptions of their hospital experience.
The HCAHPS survey asks discharged patients 27 questions about their
recent hospital stay that are used to measure the experience of
patients across 10 dimensions in the Hospital IQR program. The survey
contains 18 core questions about critical aspects of patients' hospital
experiences (communication with nurses and doctors, the responsiveness
of hospital staff, the cleanliness and quietness of the hospital
environment, pain
[[Page 2462]]
management, communication about medicines, discharge information,
overall rating of the hospital, and whether they would recommend the
hospital). The survey also includes four items to direct patients to
relevant questions if a patient did not have a particular experience
covered by the survey, such as taking new medications or needing
medicine for pain. Three items in the survey are used to adjust for the
mix of patients across hospitals, and two items related to race and
ethnicity support congressionally-mandated reports on disparities in
health care.
The HCAHPS survey is administered to a random sample of adult
patients across medical conditions between 48 hours and six weeks after
discharge; the survey is not restricted to Medicare beneficiaries.
Hospitals must survey patients throughout each month of the year. The
survey is available in official English, Spanish, Chinese, Russian and
Vietnamese versions. The survey and its protocols for sampling, data
collection and coding, and file submission can be found in the HCAHPS
Quality Assurance Guidelines, Version 5.0, which is available on the
official HCAHPS website, https://www.hcahpsonline.org.
AHRQ carried out a rigorous, scientific process to develop and test
the HCAHPS instrument. This process entailed multiple steps, including:
A public call for measures; literature review; cognitive interviews;
consumer focus groups; stakeholder input; a three-state pilot test;
small-scale field tests; and soliciting public comments via several
Federal Register notices. In May 2005, the HCAHPS survey was endorsed
by the National Quality Forum (NQF). CMS adopted the entire HCAHPS
survey as a measure in the Hospital IQR program in October 2006, and
the first public reporting of HCAHPS results occurred in March 2008.
The survey, its methodology and the results it produces are available
on the HCAPHS website at https://www.hcahpsonline.org/home.aspx. With
respect to our display of the HCAHPS measure on Hospital Compare for
purposes of the Hospital IQR program, we publicly report the measure as
10 separate items. The ``cleanliness of hospital environment,''
``quietness of hospital environment,'' ``overall rating of the
hospital,'' and ``recommend the hospital'' survey items are displayed
as stand-alone items. The remaining 6 items (communication with nurses,
communication with doctors, responsiveness of hospital staff, pain
management, communication about medicines, discharge information) are
composites of the remaining survey items.
Finally, we propose to not include the PN-5c measure in the
Hospital VBP program. We do not believe that this measure is
appropriate for inclusion because it could lead to inappropriate
antibiotic use. We intend to propose to retire this measure, as well as
several other measures that we are not proposing to adopt for the
Hospital VBP program, from the Hospital IQR program in the near future.
Accordingly, we propose to initially select the following 17
clinical process of care measures, and the HCAHPS measure, for
inclusion in the FY 2013 Hospital VBP program. The proposed list of
initial measures is provided in Table 2.
Table 2--Proposed Initial Measures for FY 2013 Hospital VBP Program
------------------------------------------------------------------------
Measure ID Measure description
------------------------------------------------------------------------
Clinical Process of Care Measures
------------------------------------------------------------------------
Acute myocardial infarction:
AMI-2............................. Aspirin Prescribed at Discharge.
AMI-7a............................ Fibrinolytic Therapy Received Within
30 Minutes of Hospital Arrival.
AMI-8a............................ Primary PCI Received Within 90
Minutes of Hospital Arrival.
Heart Failure:
HF-1.............................. Discharge Instructions.
HF-2.............................. Evaluation of LVS Function.
HF-3.............................. ACEI or ARB for LVSD.
Pneumonia:
PN-2.............................. Pneumococcal Vaccination.
PN-3b............................. Blood Cultures Performed in the
Emergency Department Prior to
Initial Antibiotic Received in
Hospital.
PN-6.........................