[Federal Register Volume 76, Number 88 (Friday, May 6, 2011)]
[Rules and Regulations]
[Pages 26490-26547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10568]
[[Page 26489]]
Vol. 76
Friday,
No. 88
May 6, 2011
Part V
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;
Final Rule
Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Rules and
Regulations
[[Page 26490]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 422 and 480
[CMS-3239-F]
RIN 0938-AQ55
Medicare Program; Hospital Inpatient Value-Based Purchasing
Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: This final rule implements a Hospital Inpatient Value-Based
Purchasing program (Hospital VBP program or the program) under section
1886(o) of the Social Security Act (the 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) (as added by section 3001(a) of the Patient Protection and
Affordable Care Act, as amended by the Health Care and Education
Reconciliation Act of 2010 (collectively known as the Affordable Care
Act)). Scoring in the Hospital VBP program will be based on whether a
hospital meets or exceeds the performance standards established with
respect to the measures. By adopting this program, we will reward
hospitals based on actual quality performance on measures, rather than
simply reporting data for those measures.
DATES: Effective Date: These regulations are effective on July 1, 2011.
FOR FURTHER INFORMATION CONTACT: Allison Lee, (410) 786-8691.
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 Final Rule and Response to Comments
A. Overview of the Proposed Rule
B. Overview of the Hospital Value-Based Purchasing Program
C. Performance Period
D. Measures
E. Performance Standards
F. Methodology for Calculating the Total Performance Score
G. Applicability of the Value-Based Purchasing Program to
Hospitals
H. The Exchange Function
I. Hospital Notification and Review Procedures
J. Reconsideration and Appeal Procedures
K. FY 2013 Validation Requirements for Hospital Value-Based
Purchasing
L. Additional Information
M. QIO Quality Data Access
III. Collection of Information Requirements
IV. Economic Analyses
A. Regulatory Impact Analysis
B. Regulatory Flexibility Act Analysis
C. Unfunded Mandates Reform Act Analysis
V. Federalism Analysis
Acronyms
Because of the many terms to which we refer by acronym in this
final rule, we are listing the acronyms used and their corresponding
meanings in alphabetical order below:
ACM Appropriate Care Model
AHRQ Agency for Healthcare Research and Quality
AMI Acute Myocardial Infarction
CCN CMS Certification number
CLABSI Central line-associated bloodstream infections
CMMI Center for Medicare and Medicaid Innovation
CMS Centers for Medicare & Medicaid Services
CV Coefficient of variation
DRA Deficit Reduction Act of 2005
DRG Diagnosis-Related Group
EHR Electronic Health Record
EKG Electrocardiogram
FISMA Federal Information Security and Management Act
HAC Hospital acquired conditions
HAI Healthcare-associated infections
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
IQI Inpatient Quality Indicator
IQR Inpatient Quality Reporting
MMA Medicare Prescription Drug, Improvement and Modernization Act of
2003
NQF National Quality Forum
PMA Patient-mix adjustment
PN Pneumonia
POA Present on Admission
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
SDPS Standard Data Processing System
SES Socioeconomic status
SSI Surgical site infections
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 Reporting program (HOQR),
formerly known as the Hospital Outpatient Quality Data Reporting
Program (HOP QDRP), and for physicians and other eligible professionals
through the Physician Quality Reporting System (formerly referred to as
the Physician Quality Reporting Initiative or 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 incentive program that links payment to
performance.
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) as the next step
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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 quality
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 toward
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 using primarily outcome and patient experience measures.
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 also seeks to develop a focused core-set of measures
appropriate to each specific provider category that reflects the level
of care and the most important areas of service furnished by 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).
To the extent practicable, measures used by CMS should be
nationally endorsed by a multi-stakeholder organization. Measures
should also 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 weighted more
heavily 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.
Comment: A number of commenters expressed their general support for
these principles. One commenter provided additional remarks on the
principles and made a number of comments on the interactions between
the principles, including risk adjustment, measure reliability, patient
experience of care measures, and measure endorsement. For example, this
commenter expressed agreement with our stated principle that public
reporting and value-based payment systems should rely on a mix of
standards, processes, outcome and payment experience measures. In
supporting this principle, the commenter related that health and health
care are complex, which requires a multifaceted accountability
framework. This commenter also supported our statement that scoring
methodologies should be reliable, as straightforward as possible, and
stable over time. The commenter further remarked that VBP relies on the
support of consumers in the marketplace to drive improvement, and that
consumers must understand the measures and how they are used in order
to make informed decisions.
Response: We appreciate the comments and input on these principles,
and will keep them in mind as we continue to enhance, develop and
implement the Hospital VBP program, other quality reporting programs,
and other value-based incentive programs.
Comment: A number of commenters stated that CMS must ensure that
value-based purchasing programs foster the development of innovative,
quality care and provide an adequate level of reimbursement for
innovative medical technologies. One commenter reiterated that value-
based purchasing programs should not place the provision of lower cost
services and products in conflict with what is best for the patient.
Response: We agree that value-based purchasing programs should not
hinder innovation and should result in improved patient care. We
believe that the Hospital VBP program will drive improvements in the
quality of care for Medicare beneficiaries, including the provision of
innovative technologies, because of its financial incentives for
providers to provide high-quality, patient-centered care coupled with
high levels of patient satisfaction. We note that our measure
development and selection activities take into account national
priorities, including those established by the National Priorities
Partnership and the Department of Health and Human Services, as well as
other widely accepted criteria established in the medical literature.
We will continue to seek to align all of our quality initiatives to
promote high-quality care and continued innovation. We intend to
monitor this program over time for unintended consequences.
Comment: One commenter requested that CMS extend the 60-day comment
period.
Response: We decline to extend the comment period. Based on the
volume and depth of comments we received in response to the Hospital
Inpatient VBP proposed rule, we believe that commenters had ample
opportunity to submit meaningful comments on our proposals and did so.
Specifically, we received comments discussing a wide range of issues on
nearly every aspect of that proposed rule, including its potential
impact on the health care system, the provision of high-quality medical
care and effects on patient satisfaction. We received comments from a
wide range of stakeholders, including hospitals, health care providers,
professional associations, trade groups, advocacy organizations,
Medicare beneficiaries, private citizens, and others. We have had a
sufficient opportunity to consider the issues raised by the commenters
and have taken their comments into account in developing this final
rule.
Comment: One commenter stated that ``the specific process for how
the agency proposes to achieve `transparency' is not described or
attained,'' and that the proposed rule did not offer sufficient
information and disclosure of the ``methods and data the agency
proposes to use'' in developing the Hospital VBP program.
Response: We disagree. We believe that we have been transparent in
making public our goals for the Hospital VBP program and numerous
documents that informed our rulemaking on this program, including the
2007 Report to Congress, Congressional testimony and public listening
session transcripts. We also believe that the proposed rule contains
detailed information regarding the data and analyses we considered in
developing our proposals.
However, because we seek to ensure that the continued development
of the Hospital VBP program take place in as transparent a manner as
possible, we will make available additional information regarding our
analyses, study results, and methods and will inform the public
accordingly.
We have addressed specific issues relating to the use of measures,
scoring
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methodology, and other aspects of the Hospital VBP program below.
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 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 applicable 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 2005
IPPS final rule (69 FR 49078) and codified the applicable percentage
increase change in Sec. 412.64(d) of our regulations. We adopted
additional requirements for 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 Applicable 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
amount for hospital inpatient operating costs by adding a 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,
provided in part that the applicable 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 applicable 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 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 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 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 before the effective
date of the change 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, as amended by section
3001(a)(2)(C) of the Affordable Care Act, requires that the Secretary
establish procedures for making information regarding measures
submitted under the Hospital IQR program available to the public after
ensuring a hospital has the opportunity to review its data. To meet
this requirement, we display most Hospital IQR program data on the
Hospital Compare Web site, http://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
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furnish. The Hospital Compare Web site currently makes public
information on a wide range of measures, including 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 http://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 subsection (d)
hospitals. In developing the plan, we were required to consider the on-
going development, selection, and modification process for measures of
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.
On November 21, 2007, we submitted the Report to Congress: Plan to
Implement a Medicare Hospital Value-Based Purchasing Program, which is
available on the CMS Web site. The report discusses options for a plan
to implement a Medicare hospital value-based purchasing 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 value-based purchasing
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
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 Affordable Care Act added a new section
1886(o) to 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 1.0 percent, 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 Final Rule and Response to Comments
A. Overview of the January 7, 2011 Hospital Inpatient VBP Program
Proposed Rule
On January 7, 2011, we issued a proposed rule that proposes to
implement a Hospital VBP program under section 1886(o) of the Act (76
FR 2454, January 13, 2011). Specifically, we proposed 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 measures would be clinical process of
care measures, which we would group into a clinical process of care
domain, and 1 measure would be the HCAHPS survey, which would fall
under a patient experience of care domain. With respect to the clinical
process of care and HCAHPS measures, we proposed to use a three-quarter
performance period from July 1, 2011 through March 31, 2012 for the FY
2013 Hospital VBP payment determination. We proposed to determine
whether hospitals meet the performance standards for the selected
measures by comparing their performance during the performance period
to their performance during a three-quarter baseline period of July 1,
2009 through March 31, 2010. We also proposed to initially adopt for
the FY 2014 Hospital VBP program three outcome measures. With respect
to the outcome measures, we proposed to use an 18-month performance
period from July 1, 2011 to December 31, 2012. Furthermore, for these
outcome measures, we proposed to establish performance standards and to
determine whether hospitals meet those standards by comparing their
performance during the performance period to their performance during a
baseline period of July 1, 2008 to December 31, 2009.
We also proposed to adopt 8 Hospital Acquired Condition measures
and 9 AHRQ Patient Safety Indicator and Inpatient Quality Indicator
outcome measures. We further proposed to begin the performance period
for each of these proposed measures 1 year after we included the
measure on the Hospital Compare Web site.
In general, we proposed to implement a methodology for assessing
the total performance of each hospital based on performance standards,
under which we would score each hospital based on achievement and
improvement ranges for each applicable measure. Additionally, we
proposed to calculate a total performance score for each hospital by
combining the greater of the
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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 proposed to convert each hospital's Total Performance
Score into a value-based incentive payment utilizing a linear exchange
function.
We provided a 60-day public comment period in which we received
approximately 319 timely comments from hospitals, health care
facilities, advocacy organizations, researchers, patients, and other
individuals and organizations. Summaries of the public comments, as
well as our responses to those comments, are set forth below.
Comment: A number of commenters requested clarification on the
interaction between the Hospital IQR program and the Hospital VBP
program. Commenters specifically requested that we explain more fully
how the penalties under the two programs will interact, as well as
clarify if we intend to continue the Hospital IQR program in the
future.
Response: The Affordable Care Act did not repeal section
1886(b)(3)(B)(viii), the statutory authority for the Hospital IQR
program, and that program will continue to exist side-by-side with the
Hospital VBP program. However, we note that beginning in FY 2015, the
reduction to the applicable percentage increase under the Hospital IQR
program changes from a straight 2.0 percentage point reduction to a
reduction equal to ``one quarter of such applicable percentage
increase'' (determined without regard to several other applicable
statutory reductions).
We also note that under section 1886(o)(1)(C)(I), hospitals that
are subject to the Hospital IQR program payment reduction for a fiscal
year are excluded from the definition of ``hospital'' for purposes of
the Hospital VBP program for that fiscal year. We interpret this
provision to mean that a hospital that does not meet the requirements
of the Hospital IQR program with respect to a fiscal year and, as a
result, will receive a reduction to the applicable percentage increase
for that fiscal year, will not be subject to the reduction to its base
operating DRG payment amount under the Hospital VBP program for that
fiscal year or be eligible to receive a value-based incentive payment
for that fiscal year.
Comment: Some commenters requested that CMS delay implementation of
the Hospital VBP program. A number of commenters urged CMS to adopt the
implementation calendar discussed in 2007 Report to Congress, in which
the first performance period would begin April 1, 2013.
Response: We are statutorily required to begin making value-based
incentive payments under the Hospital VBP program to hospitals for
discharges occurring on or after October 1, 2012 under section
1886(o)(1)(B) of the Act. Thus, the first performance period must begin
before April 1, 2013, which is the time suggested by the commenters. As
we stated in the proposed rule, in determining what performance period
to propose to adopt, we were cognizant that hospitals submit data on
the chart abstracted measures adopted for the Hospital IQR Program on a
quarterly basis, and for that reason, we believed that the performance
period should commence at the beginning of a quarter. We also
recognized that we needed to balance the length of the performance
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 proposed July 1, 2011
as the start of the performance period.
Comment: Some commenters requested additional information on how we
will educate consumers about the Hospital VBP program.
Response: We understand how crucial it is to communicate clearly
and consistently with all stakeholders in order to provide accurate and
timely information about the Hospital VBP program. We believe that
communicating in a way that promotes transparency and understanding of
the Hospital VBP program will help reduce confusion and
misunderstanding while enhancing the program's success.
To this end, we will be undertaking an extensive outreach and
education campaign to ensure that all stakeholders understand how the
Hospital VBP program works. In addition to providing information on
www.cms.gov and www.medicare.gov, as well as through other existing
mechanisms that we use to communicate with the public such as
newsletters, e-mail blasts, listserv communications, special forums,
and webinars, an important element of this campaign will be a new
Hospital VBP page on http://www.cms.gov. In addition, as required under
sections 1886(o)(10)(A) and (B), hospital specific and aggregate
information for the Hospital VBP program will be made available on the
Hospital Compare Web site.
Comment: One commenter stated that the Hospital VBP program
statutory authority overlaps with other provisions of the Affordable
Care Act and asked CMS to address the various incentives created by the
Affordable Care Act, how it intends to differentiate among separate
policies, and how it will ensure that incentives will not overlap or be
duplicative. The commenter specifically cited efforts to increase
productivity and efficiency through Accountable Care Organizations,
market basket reductions for productivity, penalties related to
hospital-acquired conditions, and payment reductions for readmissions.
Response: While there may be specific areas of overlap addressed by
the various statutory provisions and policies, the legislative
requirements, programs, and policies cited by the commenter represent
interrelated but distinct areas of efforts to improve quality in the
Medicare program. We will continue to monitor the interactions between
the policies cited by the commenter and will continue discussions with
stakeholders on this topic.
Comment: One commenter stated that all purchaser/payer value-based
strategies and programs should be supported and encouraged through the
Center for Medicare and Medicaid Innovation (CMMI).
Response: Created by the Affordable Care Act and launched on
November 16, 2010, the CMMI will examine new ways of delivering health
care and paying health care providers that can save money for Medicare
and Medicaid while improving the quality of care. CMMI will consult a
diverse group of stakeholders including hospitals, doctors, consumers,
payers, States, employers, advocates, relevant federal agencies and
others to obtain direct input and build partnerships for its upcoming
work. We agree that CMMI is an important contributor in developing
innovative strategies for value-based purchasing programs, and look
forward to continuing to leverage the Center's resources and expertise
in future years of the Hospital VBP program.
Comment: One commenter suggested that we establish a ``Pay to
Share'' pool under which funding would be provided to enable higher-
rated hospitals to instruct lower-rated hospitals on best practices.
Response: While we appreciate the comment, we do not believe we
have the statutory authority under the Act to implement such a program
at this time.
C. 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
[[Page 26495]]
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 basis, and for that
reason, we proposed that the performance period commence at the
beginning of a quarter. We also recognized that we must balance the
length of the period for collecting measure data with the need to
undertake the rulemaking process in order to propose a 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.
Therefore, we proposed to use the fourth quarter of FY 2011 (July
1, 2011 through September 30, 2011) and the first and second quarters
of FY 2012 (October 1, 2011 through March 31, 2012) as the performance
period for the clinical process of care and HCAHPS measures we proposed
to initially adopt for the FY 2013 Hospital VBP program. Under the
proposed approach, hospitals would be scored based on how well they
perform on the clinical process of care and patient experience measures
during this performance period. 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 proposed to adopt for the FY 2014 Hospital VBP program payment
determination, we proposed to establish a performance period of July 1,
2011 to December 31, 2012. We also proposed to begin the performance
period for the 8 proposed HAC measures and 9 proposed AHRQ Patient
Safety Indicator (PSI) and Inpatient Quality Indicator (IQI) outcome
measures 1 year after those measures were included on the Hospital
Compare Web site. The proposed HAC and AHRQ measures were included on
Hospital Compare on March 3, 2011.
Comment: A number of commenters requested that we adopt a 12-month
performance period for the proposed mortality measures rather than the
proposed 18-month performance period. Some were concerned that seasonal
fluctuations in mortality rates would impact the measure rates if an
18-month performance period were used instead of a 12-month period.
Response: We proposed to use an 18-month performance period (July
1, 2011 through December 31, 2012) for the three proposed mortality
measures in order to be able to increase the reliability of the measure
rates by including more cases. However, in response to the commenters'
concern about how the use of a period that is not equal to a year (or
multiple years) could introduce seasonal fluctuations into the measure
rates, we conducted additional reliability analyses on the hospital-
level risk standardized mortality rates for the proposed 30-day
mortality measures using 12 months, 18 months, and 24 months, and have
concluded that 12 months of data provides moderate to high reliability
for the Heart Failure and Pneumonia 30-day mortality measures, and is
sufficiently reliable for the AMI 30-day mortality measure. Therefore,
we are finalizing a 12-month performance period of July 1, 2011 to June
30, 2012 for the three proposed 30-day mortality measures for the FY
2014 Hospital VBP payment determination.
Comment: Some commenters expressed concern about the proposed
baseline period for the FY 2014 mortality outcome measures. Commenters
noted that the proposed 18-month baseline period would lead to data
overlap during each program year.
Response: For the reasons noted above, we are finalizing a 12-month
performance period of July 1, 2011 to June 30, 2012 for the three
proposed 30-day mortality measures for the FY 2014 Hospital VBP payment
determination. In accordance with our proposal that hospital
performance should be evaluated based on how well hospitals performed
during the same quarters in a baseline period, we are finalizing a 12-
month baseline period for the mortality outcomes measures' performance
standards calculations from July 1, 2009 to June 30, 2010. We believe
that this change will address commenters' concerns about seasonal
fluctuations in the data or overlap between program years.
Comment: Some comments requested that we require 2-3 years' worth
of data for outcome measures to ensure that the measures do not result
in any unintended consequences.
Response: As noted above, our reliability analyses for the proposed
30-day mortality measures indicate that using 12-months of data yields
sufficient reliability (moderate to high) for the HF, PN and AMI 30-day
mortality measures. We believe this time frame will enable us to
calculate the measures using reliable data. CMS will monitor this
policy to ensure that negative consequences do not occur as a result of
the shortened performance period and, if indicated, would consider
proposing to lengthen the performance period for future program years.
Comment: Many commenters generally supported our performance period
proposals given the statutory deadlines.
Response: We thank commenters for their support.
Comment: Some commenters suggested that we use 12-month performance
periods for all measures as soon as possible.
Response: We anticipate proposing to use a full year as the
performance period for all measures in the future.
After considering the public comments, we are finalizing a
performance period of July 1, 2011 through March 31, 2012 that will
apply to the clinical process of care and patient experience measures
for the FY 2013 Hospital VBP program. With respect to the FY 2014
Hospital VBP program, we are finalizing a 12-month performance period
of July 1, 2011 through June 30, 2012 that will apply to the three 30-
day mortality measures (AMI, HF, PN) that we are finalizing below. We
are also finalizing our proposal to adopt a performance period that
begins 1 year after any HAC and/or AHRQ measures that are specified for
the Hospital IQR program are included on Hospital Compare, and in
accordance with that finalized policy, the performance period for the 8
finalized HAC measures and 2 finalized AHRQ measures (discussed below)
will begin on March 3, 2012. We intend to propose the end performance
period date for the 8 finalized HAC measures and 2 finalized AHRQ
measures in the CY 2012 Outpatient Prospective Payment System proposed
rule.
D. 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) of the Act requires the Secretary to ensure that the
selected measures for FY 2013 include measures on the following
specified conditions or topics: AMI; HF; PN; surgeries, as measured by
the Surgical Care Improvement Project (SCIP); HAIs; and the HCAHPS
survey. Section 1886(o)(2)(C)(i) of the Act 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 Web
site for at least 1 year prior to the beginning of the performance
period. Section 1886(o)(2)(C)(ii) of the Act provides that a measure
selected under section
[[Page 26496]]
1886(o)(2)(A) of the Act shall not apply to a hospital if the hospital
does not furnish services appropriate to the measure.
In the FY 2011 IPPS/RY 2011 LTCHPPS Final Rule (75 FR 50188), we
stated that in future expansions and updates to the Hospital IQR
program measure set, we will be taking into consideration several
important goals. These goals include: (1) 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; (2) expanding the scope of hospital services to which
the measures apply; (3) considering the burden on hospitals in
collecting chart-abstracted data; (4) harmonizing the measures used in
the Hospital IQR program with other CMS quality programs to align
incentives and promote coordinated efforts to improve quality; (5)
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 (6)
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 stated in the proposed rule our belief that we 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. For this reason, we
proposed 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 proposed 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 proposed to adopt an initial measure set for the Hospital VBP
program. However, we also proposed to add additional measures to the
Hospital VBP program in the future in such a way that their performance
period would 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 proposed 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.
We 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 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.
As discussed in the Hospital Inpatient VBP Program proposed rule
(76 FR 2459), to determine which measures to propose to initially adopt
for the FY 2013 Hospital VBP program, we examined whether any of the
eligible Hospital IQR measures 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 stated our belief that measuring
hospital performance on topped-out measures would have no meaningful
effect on a hospital's total performance score.
We also stated that scoring a topped-out measure for purposes of
the Hospital VBP program would present a number of challenges. First,
as discussed below, we proposed that the benchmark performance standard
for all measures would be performance at the mean of the top decile of
hospital performance during the baseline period. We noted in the
Hospital Inpatient VBP Program proposed rule that, when applied to a
topped-out measure, this proposed 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 would not be 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 stated
that 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, we stated
our belief that data reporting under the Hospital VBP program would not
be the same for all hospitals. To the extent that a hospital could
report a higher proportion of topped-out measures, for which its scores
would likely be high, we stated that we believed 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
[[Page 26497]]
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 (CV) for each of the measures. The 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 5 percent
of hospitals with the lowest scores, and the 5 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 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 analysis of the impact of including the topped-out measures
discussed above indicated that their use would mask true performance
differences among hospitals and, as a result, would fail to advance our
priorities for the Hospital VBP program. We therefore proposed 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 proposed to initially adopt for the FY 2013 Hospital VBP
program. We sought comment on that proposal.
We also examined and sought comment on whether the following
outcome measures adopted for the Hospital IQR program were appropriate
for inclusion in the FY 2013 Hospital VBP program. These measures are
as follows: (1) AHRQ PSIs, IQIs and composite measures; (2) AHRQ PSI
and nursing sensitive care measure; and (3) AMI, HF, and PN mortality
measures (Medicare patients). We stated our belief that these outcome
measures provide important information relating to treatment outcomes
and patient safety. We also stated in the proposed rule that we 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 Hospital Compare for a
least 1 year prior to the beginning of the performance period, we
stated that the AHRQ PSIs, IQIs and composite measures, and the AHRQ
Nursing Sensitive Care measure were not yet eligible for inclusion in
the FY 2013 Hospital VBP program. Although these measures are currently
specified for the Hospital IQR program, we acknowledged that as of the
time we issued the proposed rule, they did not meet the one year
Hospital Compare inclusion requirement.
We also 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. The
eligible clinical process of care measures we considered covered AMI,
HF, PN, and surgeries as measured by the SCIP. Therefore, we believe
that they meet the requirements of section 1886(o)(2)(B)(i)(I)(aa)-(dd)
of the Act, which requires us to include measures covering these
conditions or procedures. Section 1886(o)(2)(B)(i)(ee) of the Act also
requires the Secretary to select for purposes of the FY 2013 Hospital
VBP program measures that cover HAIs ``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 discussed
above were developed to support practices that have demonstrated an
ability to significantly reduce surgical complications such as HAIs.
Compliance with the selected 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 Web site. 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); we proposed to
adopt them for the FY 2013 Hospital VBP program and to categorize them
under the 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 HCAHPS
survey. CMS partnered with AHRQ to develop HCAHPS. The HCAHPS survey is
the first national, standardized, publicly reported survey of patients'
experience of hospital care, and we proposed 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 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
[[Page 26498]]
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 6 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 Web site, http://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 NQF, and in December 2005, the Federal Office of Management and
Budget gave its final approval for the national implementation of
HCAHPS for public reporting purposes. 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 in the
public domain.
As previously discussed, in determining what clinical process of
care measures to propose, we analyzed the impact of including topped-
out measures and determined that their use would mask true performance
differences among hospitals, thus failing to advance our quality
priorities. As a result, we proposed to exclude 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) from the list of measures we proposed to
initially adopt for the FY 2013 Hospital VBP program.
We did not propose 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.
Therefore, we solicited public comment 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.
Finally, we proposed to exclude the PN-5c measure from the Hospital
VBP program. We do not believe that this measure is appropriate for
inclusion because it could lead to inappropriate antibiotic use. We
proposed retiring this measure, as well as several other measures that
we will not adopt for the Hospital VBP program, from the Hospital IQR
program in the FY 2012 IPPS/LTCH PPS proposed rule scheduled for
publication on May 5, 2011.
We proposed to initially select 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
1.
Table 1--Proposed 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.............................. Initial Antibiotic Selection for CAP
in Immunocompetent Patient.
PN-7.............................. Influenza Vaccination.
------------------------------------------------------------------------
Healthcare-associated infections
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
Surgeries
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
[[Page 26499]]
Patient Experience of Care Measures
------------------------------------------------------------------------
HCAHPS............................ Hospital Consumer Assessment of
Healthcare Providers and Systems
Survey.\1\
------------------------------------------------------------------------
In the Hospital Inpatient VBP Program proposed rule, we solicited
public comments on our intention to add measures to the Hospital VBP
Program as rapidly as possible for their availability in future
performance periods. To that end, we proposed 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
proposed 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 Hospital Compare for at least 1 year. We proposed that the
performance period for all of these measures would start exactly 1 year
after the date these measures were publicly posted on Hospital Compare,
consistent with section 1886(o)(2)(C)(i). Under this proposed
subregulatory process for adopting new Hospital VBP program measures,
we would solicit comments from the public on the appropriateness of
adopting 1 or more Hospital IQR measures for the Hospital VBP program.
We would also assess the reported Hospital IQR measure rates using the
criteria we used to select the measures for the initial FY 2013
Hospital VBP measure set and would notify the public regarding our
findings. We stated that we would propose to set performance period end
dates for any measure we selected for future Hospital VBP program years
in rulemaking.
---------------------------------------------------------------------------
\1\ Proposed dimensions of the HCAHPS survey for use in the FY
2013 Hospital VBP program are: Communication with Nurses,
Communication with Doctors, Responsiveness of Hospital Staff, Pain
Management, Communication about Medicines, Cleanliness and Quietness
of Hospital Environment, Discharge Information and Overall Rating of
Hospital.
---------------------------------------------------------------------------
We also proposed to implement a subregulatory process to retire
Hospital VBP measures. Under the proposed process, we would post our
intention to retire measures on the CMS Web site at least 60 days prior
to the date that we would retire the measure. Also, as we do with
respect to Hospital IQR measures that we believe pose immediate patient
safety concerns if reporting on them is continued, we proposed that we
would 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 post 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 made this proposal because it would allow us
to ensure that the Hospital VBP program measure set focuses on the most
current quality improvement and patient safety priorities. We solicited
public comment on our proposals and other methods that allow for the
addition of measures to the Hospital VBP program as rapidly as possible
in order to improve quality and safety for patients.
In addition, we sought public comment on efficiency measures
required for inclusion in the Hospital VBP program for value-based
incentive payments made with respect to discharges occurring during FY
2014 or a subsequent fiscal year. Specifically, we requested comment on
what services should be included and what should be excluded in a
``Medicare spending per beneficiary'' calculation, and what, if any,
type(s) of hospital segmentation or adjustment should be considered in
such a measure. We also solicited comment on approaches for measuring
internal hospital efficiency. We took these comments into account in
the development of the Medicare spending per beneficiary measure that
we proposed to adopt in the FY 2012 IPPS/LTCH PPS proposed rule
scheduled for publication on May 5, 2011, available at http://www.ofr.gov/inspection.aspx?AspxAutoDetectCookieSupport=1).
The public comments we received are set forth below.
Comment: Some commenters agreed with our proposed measure set and
our proposal to exclude PN-5c and structural measures.
Response: We thank the commenters for their support. We believe
that the structural measures we have adopted for the Hospital IQR
program require further development before we can consider adopting
them for the Hospital VBP program, including the development of an
appropriate scoring methodology. We also believe that the inclusion of
PN-5c measure could lead to inappropriate antibiotic use. We also note
that we have proposed to retire the PN-5c measure from the Hospital IQR
program in the FY 2012 IPPS/LTCH PPS proposed rule scheduled for
publication on May 5, 2011 for the same reason that we proposed to not
include it in the Hospital VBP program measure set.
Comments: Some commenters noted that CMS is retiring PN-2
(Pneumococcal Vaccination) and PN-7 (Influenza Vaccination) from the
Hospital IQR Program and asked why these measures were included in the
proposed rule. These commenters wanted to know how the retirement of
these measures from the Hospital IQR Program would affect how these
measures were collected and scored under the Hospital VBP program.
Other commenters were concerned about including pneumonia vaccination
measures in the Hospital VBP program measure set because they stated
that there may be clinical reasons why a physician does not want a
patient to receive the vaccination. The commenters suggested adding an
``allowable value'' or allowable code to the measure specifications to
avoid penalizing the hospital for that situation.
Response: Commenters are correct in that we finalized our
retirement of PN-2 (Pneumococcal Vaccination) and PN-7 (Influenza
Vaccination) beginning with the FY 2014 Hospital IQR program payment
determination (75 FR 50211), and hospitals will no longer be required
to submit data on these measures beginning with January 1, 2012
discharges (75 FR 50221). Because these measures will cease to continue
being Hospital IQR program measures midway through the performance
period we are finalizing for the FY 2013 Hospital VBP program, we do
not believe that we can include them in the FY 2013 Hospital VBP
measure set.
Comment: One commenter requested clarification on whether we
proposed to include SCIP-Inf-6 in the FY 2013 Hospital VBP measure set.
Response: Table 2 of the Hospital Inpatient VBP proposed rule (76
FR 2462) listed our proposed measures for FY 2013, and Table 2 of this
Final Rule lists the finalized measures. As we
[[Page 26500]]
explained in the Hospital Inpatient VBP proposed rule (76 FR 2461), we
proposed not to adopt SCIP-Inf-6 for the Hospital VBP program because
we concluded that the measure had achieved a ``topped out'' status.
Comment: A commenter suggested that the proposed clinical process
of care measures are flawed, suggesting that hospitals might choose not
to submit records that could adversely impact their total performance
score when submitting quality data.
Response: All Hospital VBP program measures must be selected from
the measures specified under the Hospital IQR program, and the data
that we will use to calculate a hospital's total performance score for
the clinical process of care measures will be the same data that the
hospital submitted on those measures under the Hospital IQR program.
We allow hospitals to submit Hospital IQR clinical process of care
measure data either by abstracting the necessary data elements from all
qualifying cases or by submitting data elements taken from a sample of
those cases. If the hospital chooses to submit a sample, the sample
must meet the population and sample requirements outlined in the
Specifications Manual. This Specifications Manual is posted on the CMS
QualityNet Web site at https://www.QualityNet.org/. The purpose of
these requirements is to ensure that the sample is statistically valid.
We also note that we have adopted a process for validating clinical
process of care measure data submitted under the Hospital IQR program,
and we stated in the Hospital Inpatient VBP program proposed rule our
belief that this process will also assure us that the same data is
accurate for purposes of assessing hospital performance under the
Hospital VBP program.
Comment: Several commenters asked if CMS will monitor ``topped-
out'' measures to ensure that they remain ``topped-out''.
Response: At this time, we do not have a mechanism in place to
monitor whether measures we do not adopt for the Hospital VBP program
on the basis that they are topped-out remain topped-out. We will
consider such monitoring in the future.
Comment: Some commenters suggested that CMS include in the Hospital
VBP program measures that meet the definition of ``topped out'' because
some hospitals will still be able to demonstrate improvement on them.
Response: As detailed in the Hospital Inpatient VBP proposed rule
(76 FR 2460), we proposed to define a ``topped out'' measure as a
measure for which hospital performance at the 75th and 90th percentiles
are statistically indistinguishable, and the truncated CV was set at
<0.10. We believe that if a measure is ``topped out,'' there is no room
for improvement for the vast majority of hospitals, and that measuring
hospital performance on that measure will not have a meaningful effect
on a hospital's Total Performance Score. For that reason, we proposed
to exclude 7 topped-out measures from the FY 2013 Hospital VBP measure
set.
Comment: We received several comments asking us to re-run our
analysis of ``topped-out'' measures using more recent data to determine
if any other measures also met that status.
Response: At the time we issued the Hospital Inpatient VBP proposed
rule, the most recent data that was available to assess whether the
proposed measures met our proposed definition of ``topped out'' was
data from July 1, 2008 through March 31, 2009 which was the most recent
validated data available and publicly displayed under the Hospital IQR
program. However, since that time, data from the period that we
proposed to set as the baseline period for the FY 2013 proposed
measures has been validated (that is, data from the period July 1, 2009
to March 31, 2010). Therefore, in response to these comments, we
analyzed all of the proposed FY 2013 measures to see if any of them met
our proposed definition of ``topped out'' using this more recent data.
We determined that three additional measures: AMI-2: Aspirin Prescribed
at Discharge; HF-2: Evaluation of LVS Function; and HF-3: ACEI or ARB
for LVSD meet our proposed definition of ``topped-out'' based on this
more recent data. Because one of our goals for the Hospital VBP program
is to ensure that hospital performance can be meaningfully measured and
distinguished, we believe that it is appropriate to exclude these three
additional measures from the FY 2013 Hospital VBP measure set based on
this more recent analysis.
Comment: Some commenters suggested that we consider SCIP-Inf-2 and
PN-3b for ``topped out'' status. Other commenters stated, generally,
that other measures should be considered for ``topped-out'' status,
particularly those on which the difference between median performance
and top performance is small. One commenter stated that it had
calculated achievement thresholds and benchmark scores for the proposed
measures using data available on Hospital Compare that most closely
matched data from CMS' proposed baseline period. The commenter stated
that its analysis showed that with respect to several measures,
hospital scores were clustered at a high level of achievement, and
suggested that such measures should also be considered as ``topped
out.''
Response: As discussed above, we examined all of the proposed
measures using data from the baseline period that we are finalizing in
this final rule, and determined that three additional measures (AMI-2,
HF-2, HF-3) are topped-out based on this data. As for other measures,
including SCIP-Inf-2 and PN-3b, for which performance is high but which
do not meet the proposed definition of ``topped-out'' based on the more
recent data, the data show that hospital performance on these measures
can still be meaningfully distinguished. For this reason, we believe
that it is appropriate to include these measures in the FY 2013
Hospital VBP measure set.
Comment: One commenter suggested that we not include the HF-1
measure (Discharge Instructions) from the Hospital VBP program because
the measure does not measure clinical care provided, but instead
measures administrative processes. Another commenter suggested that we
exclude AMI-2, HF-1, HF-2 and SCIP-VTE-2 from the Hospital VBP program
because these measures do not represent a significant improvement in
the clinical practices required to deliver high value health care.
Response: We disagree. The HF-1 measure, Discharge Instructions,
assesses several critical elements important to a discharged patient:
Activity level, diet, discharge medications, follow-up appointment,
weight monitoring, and what to do if symptoms worsen. These elements
are critical to ensuring that patients continue to receive appropriate,
high-quality health care services after their discharge from the
hospital. We believe that SCIP-VTE-2 is important for the Hospital VBP
program because the optimal start of pharmacologic prophylaxis in
surgical patients can significantly decrease the mortality and
morbidity associated with blood clot formation.
As described above, we are not finalizing our proposal to include
AMI-2 and HF-2 in the FY 2013 Hospital VBP measure set because based on
an analysis involving data from the proposed baseline period, these
measures meet our proposed definition of ``topped-out.''
Comment: One commenter suggested that we review the technical
specifications for AMI-7a and AMI-8a to ensure that intervention timing
is based on diagnosis by EKG.
[[Page 26501]]
Response: The intervention timing for both AMI-7a and AMI-8a runs
from the time of arrival, not the time of diagnosis by EKG.
Specifically, the specifications for the AMI-7a measure state that AMI
patients with ST-segment elevation or Left bundle branch block (LBBB)
on the EKG closest to arrival time receiving fibrinolytic therapy
during the hospital stay have a time from hospital arrival to
fibrinolysis of 30 minutes or less. Similarly, the specifications for
the AMI-8a measure state that AMI patients with ST-segment elevation or
LBBB on the ECG closest to arrival time receiving primary PCI during
the hospital stay have a time from hospital arrival to PCI of 90
minutes or less. These specifications can be found on the QualityNet
Web site (http://www.qualitynet.org). We note that these specifications
are based on clinical guidelines adopted by the American College of
Cardiology (ACC) clinical guidelines for ST elevation MI.
Comment: Some commenters expressed support for our exclusion of
structural measures. Others suggested that we consider using specific
structural measures in the future such as participation in a systematic
database or registry.
Response: We believe these measures require further analysis of how
they could be scored, and how they would impact a hospital's total
performance score before they can be adopted for the Hospital VBP
program. We intend to consider these issues as the Hospital VBP program
evolves.
Comment: One commenter suggested including the three smoking
cessation measures adopted for the Hospital IQR program (AMI-4, HF-4,
PN-4), despite their ``topped out'' status, because of the risk that
hospitals will not focus on these measures and overall performance
could begin to decline.
Response: These measures meet our proposed definition of topped-out
status. As we have stated, we do not believe that measuring performance
on a topped-out measure produces a meaningful differentiation of
hospital performance. We also note that we have proposed to retire
these measures from the Hospital IQR measure set in the FY 2012 IPPS/
LTCH PPS proposed rule scheduled for publication on May 5, 2011.
Therefore, we are excluding these measures from the Hospital VBP
measure set. We will consider the feasibility of proposing to adopt a
global smoking cessation measure for the Hospital VBP program.
Comment: A number of commenters supported our proposal to include
PN-6 and PN-3b in the Hospital VBP measure set, stating that these
measures encourage use of new technologies after patient diagnosis.
Response: We appreciate the support, and we believe that the
inclusion of these measures will help promote the provision of quality
care by promoting appropriate laboratory testing (taking of blood
cultures to facilitate selection of the most effective antibiotic for
the patient) and actual selection of appropriate antibiotics based on
patient data.
Comment: Some commenters supported our proposal to use SCIP
measures to capture HAIs.
Response: We thank commenters for their support. As discussed in
the Hospital Inpatient VBP Program proposed rule (76 FR 2461), the SCIP
measures were developed to support practices that have demonstrated an
ability to significantly reduce surgical complications such as HAIs.
Compliance with the proposed SCIP infection measures is also included
as a targeted metric in the HHS Action Plan to Prevent Healthcare-
Associated Infections issued in 2009, a copy of which is available on
the HHS Web site.
Comment: One commenter suggested that measures should assess
services regularly provided by rural hospitals and hospitals that do
not perform surgeries.
Response: The measures selected for the Hospital VBP program
address services provided by subsection (d) hospitals, including rural
hospitals and hospitals that do not perform surgeries. For example, the
HCAHPS dimensions measure patients' experiences of care at hospitals;
none of the dimensions are surgery-specific. Additionally, pneumonia
and other conditions such as heart failure and acute myocardial
infarction are treated by rural hospitals.
Comment: A number of commenters called on CMS to use the Joint
Commission's accountability criteria for measure selection, which
include strong scientific evidence of improved outcomes, proximity to
impacted outcomes, accurate assessment of evidence-based processes and
minimal adverse effects.
Response: In August 2010, The Joint Commission published an article
in the New England Journal of Medicine discussing the criteria that
should be used to define a measure that is used for accountability and
public reporting purposes versus criteria that is used to define
measures used strictly for performance improvement. The Joint
Commission identified four criteria a measure must have in order to
have the greatest positive impact on patient outcomes. These criteria
include: Research, Proximity, Accuracy, and Adverse Effects. Further
information on the Joint Commission's accountability criteria may be
found at http://www.jointcommission.org/about/JointCommissionFaqs.aspx?CategoryId=31. We generally agree with the
Joint Commission's list of criteria that would apply to measures used
for accountability purposes and considered this criteria in determining
whether certain measures may warrant retirement from the Hospital IQR
program. However, we do not agree with their exclusion of HF-1 from the
list of accountability measures as we believe HF-1 assesses a
hospital's compliance with providing critical information to patients
at the time of their discharge, including instructions regarding
activity level, diet, discharge medications, follow-up appointment,
weight monitoring, and what to do if symptoms worsen. As stated above,
we believe that this information is critical for hospitals to provide
in order to facilitate appropriate self-care and provider follow up
care after a patient is discharged from the hospital.
Comment: A number of commenters recommended that we analyze
measures against pre-established, agreed-upon criteria to ensure that
they are relevant to value-based purchasing and will improve health
outcomes for patients. Some commenters suggested that our goal should
be to find the most appropriate ways to tie measures to patient
benefits. Some commenters argued that current measures which we have
proposed to adopt for the Hospital VBP program do not sufficiently
impact health outcomes. Other commenters wondered if any measures are
``paper-only'' and do not reflect the actual provision of quality
medical care.
Response: To ensure that measures assess the quality of care
provided to Medicare beneficiaries, we agree that measures should be
scrutinized by experts and evaluated against objective criteria. We
believe that these elements have been incorporated into our measure
selection process in a variety of ways, including through endorsement
by consensus-developing entities and through notice and public comment
rulemaking. For example, most of the measures that we have selected for
the Hospital IQR program, (which make them candidates for the Hospital
VBP program) are endorsed by the NQF, the entity with a contract with
the Secretary under Section 1890(a) of the Act. To the extent that we
have determined that measurement is needed in a specified area for
which there are no NQF endorsed measures, we give due consideration to
measures endorsed or adopted by different consensus
[[Page 26502]]
organizations before specifying the measure. We also consider whether
the measures meet the goals of the National Priorities Partnership,
enable the Department to further its strategic goals and initiatives,
and whether they are adopted by the HQA. This has resulted in our
adoption of meaningful measures that assess the quality of care
furnished by hospitals.
Comment: A few commenters were concerned that the HCAHPS scores
publicly reported on Hospital Compare differ by bed size, type of
hospital and geography and thought the HCAHPS scores should be adjusted
for these factors. These commenters thought HCAHPS needs to be vetted
more to understand these differences to ensure that HCAHPS is a
reliable measure.
Response: Although we recognize that HCAHPS results differ by bed
size and other hospital characteristics, we do not interpret these
differing results to mean that the survey should be risk adjusted.
HCAHPS results also differ among hospitals with the same
characteristics, which we view as evidence that the results account for
differences in the quality of care received by patients. In general,
risk adjustment models control for exogenous factors that are beyond
the control of a hospital, not for hospital characteristics that are
endogenous, or within their control.
We also believe that the HCAHPS survey has been thoroughly vetted,
including through reviews in peer-reviewed journals and through notice
and comment rulemaking when we adopted it for the Hospital IQR program,
and it is endorsed by the NQF.
Comment: One commenter questioned whether top-box responses in the
HCAHPS survey are appropriate for urban, safety net hospitals that
serve culturally diverse patients and may not be able to ``always''
communicate well with their patients.
Response: The ``top-box'' response to HCAHPS survey items is the
most positive response that a patient can provide (often presented in
the survey as ``Always''). Medicare does not have an indicator for a
``safety net hospital.'' However, we have examined the HCAHPS results
submitted by urban hospitals, which we believe can serve as a rough
proxy for a ``safety net hospital.'' Urban hospitals, particularly
large ones, have historically not performed as well on HCAHPS as rural
hospitals. However, our internal studies of HCAHPS results show that
hospitals in the following urban areas scored in the top 25 percent of
hospitals overall: New York City, Boston, Baltimore, Atlanta, Chicago,
Los Angeles, San Francisco, San Diego, Phoenix, Dallas, Houston, and
San Antonio. We believe that these results suggest that urban hospitals
are not being disadvantaged by the HCAHPS measurement.
Comment: Several commenters questioned the reliability of HCAHPS
data. Some suggested that we consider possible negative consequences
associated with its use.
Response: Since its national implementation in October 2006, when
hospitals began to administer the HCAHPS survey, our analyses of HCAHPS
results has shown that this standardized, publicly reported survey of
patients' experience of hospital care is satisfactorily reliable at 100
completed surveys using statistical measures of reliability that
calculate the proportion of the variance in reported hospital scores
that is due to true variation between hospitals, rather than within
hospital variation that reflects limited sample size.
We also note that since public reporting of HCAHPS scores began
under the Hospital IQR program[?] in March 2008 there have been small
but statistically significant improvements in 9 of 10 HCAHPS
dimensions.\2\ In addition, we are aware of abundant anecdotal evidence
that hospitals are engaging in quality improvement efforts aimed at
improving the quality of the inpatient experience. We believe that
HCAHPS, in part, motivates these efforts and expect that hospitals will
continue to improve their patients' experience of care as the
incentives for doing so become more salient.
---------------------------------------------------------------------------
\2\ See ``Hospital Survey Shows Improvements in Patient
Experience.'' M.N. Elliott, W.G. Lehrman, E.H. Goldstein, L.A.
Giordano, M.K. Beckett, C.W. Cohea and P.D. Cleary. Health Affairs,
29 (11): 2061-2067. 2010.
---------------------------------------------------------------------------
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, we also
proposed that, for inclusion in the Hospital VBP program for FY 2013,
hospitals must report a minimum of 100 HCAHPS surveys during the
performance period. Our statistical analyses show that HCAHPS is a
reliable measure of patient experience and, therefore, we see no
negative consequences with its use.
Comment: One commenter provided suggestions for additional items
regarding palliative care that could be added to the HCAHPS instrument;
another commenter suggested that CMS add questions about patient
activation (patients' knowledge, skills, and confidence for self-
management), care coordination, shared decision-making and support for
patient self-management.
Response: As part of our ongoing maintenance activities for the
HCAHPS survey, which include assessing whether it needs to be updated,
we will consider the feasibility of adding the suggested survey items.
Comment: One commenter wanted to exclude the doctor communication
dimension from the HCAHPS measure, reasoning that hospital payment
under the IPPS should not be based in part upon physician behavior that
it cannot control.
Response: We are including the doctor communication dimension as an
HCAHPS dimension because it is a key aspect of care from the
perspective of consumers. In addition, many hospitals employ their own
doctors (hospitalists) who are directly under the hospitals' control.
Comment: Some commenters opposed combining the cleanliness and
quiet items because they are conceptually different and the cleanliness
item is important for patient safety.
Response: We thank commenters for their input. Although these two
items were originally proposed to be one composite in the survey, we
separated them into two individual measures for public reporting prior
to the 2006 national implementation because it made more sense for
consumers to see ``clean'' and ``quiet'' as distinct environmental
aspects of hospitals. The ``clean'' and ``quiet'' HCAHPS measures will
continue to be publicly reported separately on Hospital Compare for the
Hospital Inpatient Quality Reporting program.
For purposes of the Hospital VBP program, these two items were
combined so as not to put more weight on the environmental items
compared to the rest of the HCAHPS items, which are composite measures
(with the exception of Overall Rating). If the environmental items were
separated, quietness of the hospital environment, for example, would
receive as much weight as nurse communication, which includes 3 items
from the HCAHPS survey. The combined ``cleanliness and quietness''
HCAHPS dimension will be publicly reported on Hospital Compare as part
of the Hospital VBP program.
Comment: Some commenters were concerned that the risk adjustment
models for the HCAHPS survey are not adequate and do not control for
the severity of a patient's condition, socio-economic status, and
geographic differences
[[Page 26503]]
Response: HCAHPS dimensions are currently patient-mix adjusted. We
adjust HCAHPS data for patient characteristics that are not under the
control of the hospital that may affect patient reports of hospital
experiences. The goal of adjusting for patient-mix is to estimate how
different hospitals would be rated if they all provided care to
comparable groups of patients. As part of the endorsement process for
HCAHPS, the NQF endorsed the HCAHPS patient-mix adjustment currently in
use.
The HCAHPS patient-mix adjustment (PMA) model incorporates
important and statistically significant predictors of patients' HCAHPS
ratings that also vary meaningfully across hospitals (O'Malley et al.,
2005). The PMA model includes seven variables, as follows: Self-
reported health status, education, service line (medical, surgical, or
maternity care), age, response percentile order (also known as
``relative lag time,'' which is based on the time between discharge and
survey completion), service line by linear age interactions, and
primary language other than English. Initially the model also included
admission through an emergency room, but because admission through an
emergency room is no longer available on the UB-92 Form, this adjuster
is no longer available for the patient-mix model. We are exploring
other options to obtain that information in the future. We have found
that evaluations of care increase with self-rated health and age (at
least through age 74), and decrease with educational attainment.
Maternity service has generally more positive evaluations than medical
and surgical services. Percentile response order (relative lag time)
findings show that late responders tend to provide less positive
evaluations than earlier responders. From research conducted during the
development of HCAHPS, we found little evidence that DRG matters beyond
the service line, which is included in the patient mix model.
To further address specific concerns about the adjustment model, it
is important to note that self-reported health status is a widely
accepted measure of a person's overall health status. In general, ``how
would you rate your health'' is the most widely used single self-
reported health item and is used in a plethora of national health
surveys. Education also captures important aspects of socio-economic
status. Income is generally not available to adjust survey data.
Patient-mix adjustment is based on variation by patient-level
factors within hospitals so that true differences between hospitals are
not included in the adjustment.\3\ Controlling for geographic region (a
hospital-level factor) as part of a patient-mix adjustment model could
mask important differences in quality across the country.
---------------------------------------------------------------------------
\3\ See ``Adjusting Performance Measures To Ensure Equitable
Plan Comparisons.'' Zaslavsky, A.M., L.B. Zaborski, D.J.A. Shaul,
M.J. Cioffi, and P.D. Cleary. Health Care Financing Review'' 22(3):
109-26. 2001.
---------------------------------------------------------------------------
Comment: Several commenters suggested changing the HCAHPS
requirements to reduce the number of required mailings and telephone
attempts, allow survey administration while patients are still in the
hospital, and allow electronic administration of the survey to reduce
the cost of survey administration.
Response: We know from our HCAHPS research that, on average, late
responders report less positive experiences. For this reason, we
believe that allowing hospitals to reduce their effort to obtain
completed surveys by reducing the required number of mailings and
telephone attempts would bias the HCAHPS results. Under the current
HCAHPS requirements, which can be found in the HCAHPS Quality Assurance
Guidelines available at www.hcahpsonline.org, the administration of the
HCAHPS survey begins 48 hours following discharge to ensure that the
patient has had an opportunity to return home or go to an alternative
location. We also believe that allowing a hospital to administer the
survey while the patient is still in the hospital has the potential to
create biased results because the patient might not feel that he or she
can freely answer the questions with hospital staff nearby.
We note that we have tested an Internet version of HCAHPS. However,
at this point, we do not believe that hospitals routinely collect e-
mail addresses or that the Medicare population has enough experience
with the Internet to support allowing hospitals to administer the
survey via the Internet. This is a technology that we will continue to
explore because we agree with the commenters that electronic
administration of the survey would be less expensive for hospitals.
Comment: One commenter was concerned that patients would be more
likely to recommend larger hospitals due to the spectrum of services
offered by them and, thus, smaller and rural hospitals would be
disadvantaged by HCAHPS.
Response: Because HCAHPS focuses on the actual experiences of care
by asking patients about what happened during the hospital stay, the
HCAHPS data are not biased by the perceptions of patients in terms of
the range of services offered by different hospitals. In fact, smaller
hospitals generally tend to do better on HCAHPS relative to larger
ones.
While most HCAHPS survey items assess the patient's actual
experience in the hospital, two survey items ask for the patient's
overall impressions of the hospital stay. Because these items are
highly correlated and potentially draw on wider influences, we have
proposed to include only one global dimension, Overall Rating, in the
Hospital VBP program scoring for the HCAHPS measure.
Comment: Some commenters called on us to make HCAHPS patient mix
adjustment formulas public.
Response: The HCAHPS patient-mix adjustment formulas are publicly
available on http://www.hcahpsonline.org. The data on http://www.hcahpsonline.org regarding the adjustments are updated quarterly.
Comment: Some commenters opposed the use of 30-day mortality rates
in the Hospital VBP program because they are ``all-cause'' measures and
do not exclude deaths that are not attributable to a hospital's quality
of care. One commenter questioned the use of the mortality measures,
citing the possibility of unintended consequences and remarking that,
``unless hospitals are provided with specific interventions which have
been demonstrated to reduce morality, penalizing a hospital for an
increase in mortality (or rewarding one for a decrease in mortality) is
not rationally related to the operations of the hospital.'' Other
commenters argued that the Hospital VBP program should focus on outcome
measures that are risk adjusted to account for extremely ill patients.
Response: We appreciate commenters' input on measures for use in
the Hospital VBP program. The proposed all-cause risk adjusted 30-day
mortality measures are endorsed by the National Quality Forum (NQF).
There are several reasons why we believe it is appropriate for us to
adopt the NQF-endorsed all-cause mortality measures for the Hospital
VBP program.
First, from the patient perspective, death is the key outcome
regardless of its cause. Second, cause of death may be unreliably
recorded. Third, the cause of death may represent a complication
related to the underlying condition. For example, a patient with HF who
develops a hospital-acquired infection may ultimately die of sepsis and
multi-organ failure. It would be inappropriate to consider the death as
unrelated to the care the patient received for HF.
[[Page 26504]]
Another patient might have a complication leading to renal failure,
resulting in death, and yet quality of care could have reduced the risk
of the complication. A patient with PN who did not receive deep vein
thrombosis prophylaxis may ultimately die of a pulmonary embolism. It
would be inappropriate to consider the death as unrelated to the care
the patient received for PN. Although this approach will include some
patients whose death may be unrelated to their care (for example, a
casualty in a motor vehicle accident), events completely unrelated to
the admission are expected to be uncommon and should not be clustered
unevenly among hospitals.
Furthermore the NQF-endorsed measure methodology for all three of
these all-cause mortality measures includes a risk adjustment for
protein-calorie malnutrition, dementia, and metastatic cancer that are
common among extremely ill patients.
Comment: Some commenters suggested that we should ensure that
measures, particularly those added in FY 2014, appropriately capture
services provided by hospitals, as not all hospitals treat all
conditions.
Response: We agree and note that we proposed that hospitals must
have at least 10 cases per measure in order to be scored on that
measure and report on at least 4 measures to be included in the
Hospital VBP program. We also believe that the finalized Hospital VBP
measures capture a broad range of hospital services, which will enable
a large number of hospitals to participate in the program.
Comment: One commenter suggested that we proceed cautiously in
seeking to adopt outcome measures for the Hospital VBP program, and
that we first demonstrate their statistical reliability for low-volume
hospitals.
Response: We agree that acceptable statistical reliability is
important to our analysis in determining what measures to adopt for the
Hospital VBP program. As stated above, we conducted analyses on the 30-
day outcome measures we are adopting for this program and have found
them to be reliable for all hospitals for purposes of Hospital VBP
scoring.
Comment: One commenter suggested that CMS use an error bar or other
visual display of the confidence intervals surrounding mortality rate
performance similar to the displays currently used on Hospital Compare
for mortality measures.
Response: The confidence intervals currently shown on Hospital
Compare are used to classify hospitals into broad categories for
purposes of that display. For the Hospital VBP program, we will score
all of the Hospital VBP measures using the scoring methodology that we
finalize for the program. The use of this scoring methodology will
result in each hospital being assigned a point estimate that reflects
its score on each of the mortality measures, and it is those scores,
rather than broad confidence intervals, that will be used for purposes
of the public reporting.
Comment: Some commenters expressed general support for the 3
proposed 30-day mortality measures.
Response: We thank commenters for their support.
Comment: Some commenters suggested that we exclude some types of
cases, including hospice or palliative care, from the mortality measure
calculations. They also suggested that this ``new'' mortality rate
measurement without hospice and palliative care patients should be
displayed on Hospital Compare for one year prior to implementation.
Response: The risk-adjusted mortality measure methodology excludes
admissions for Medicare fee-for-service patients who elect hospice care
any time in the 12 months prior to the index hospitalization, including
the first day of the index admission. Information on the methodology
used to calculate the measures can be found at http://www.qualitynet.org/dcs/ContentServer?c=Page&pagename=QnetPublic%2FPage%2FQnetTier2&cid=1163010398556.
Comment: Many commenters opposed our proposal to adopt HAC measures
for the FY 2014 Hospital VBP program, arguing that we will be
penalizing hospitals on those measures both under the Hospital VBP
program, the HAC policy required by Section 3008 of the Affordable Care
Act and the Medicaid penalties required by Section 2702 of the
Affordable Care Act.
Response: We view the program authorized by section 3008 of the
Affordable Care Act and the Hospital VBP Program as being related but
separate efforts to reduce HACs. Although the Hospital VBP program is
an incentive program that provides incentive-based payments to
hospitals based on quality performance, the program established by
section 3008 of ACA creates a payment adjustment resulting in payment
reductions for the lowest performing hospitals. We also view programs
that could potentially affect a hospital's Medicaid payment as separate
from programs that could potentially affect a hospital's Medicare
payment, although we intend to monitor the various interactions of
programs authorized by the Affordable Care Act and their overall impact
on providers and suppliers.
Comment: Several commenters requested that we ensure the
harmonization of new programs and any overlay or duplication in the
Affordable Care Act, generally.
Response: We are coordinating the development and implementation of
all of these programs and will continue to monitor their impacts on
providers and suppliers.
Comment: Some commenters argued that CMS should analyze HAC
measures more closely to test the validity of ``present on admission''
(POA) diagnosis coding. The commenters suggested that CMS compare POA
coding to chart-review to test the appropriateness of using claims-
based measures for payment purposes. Commenters more generally argued
that the current measure format does not allow for valid comparisons
due to coding issues and physician behavior.
Response: The purpose of POA coding is to allow better discernment
of whether a diagnosis is a complication of care received in the
hospital or an adverse event occurring in the hospital. Beginning in FY
2007, we have proposed, solicited, and responded to public comments and
have implemented the Hospital Acquired Condition Program under section
1886(d)(4)(D) of the Act and its accompanying POA coding requirement
through the IPPS annual rulemaking process. For specific policies
addressed in each rulemaking cycle, we direct readers to the following
publications: the FY 2007 IPPS proposed rule (71 FR 24100) and final
rule (71 FR 48051 through 48053); the FY 2008 IPPS proposed rule (72 FR
24716 through 24726) and final rule with comment period (72 FR 47200
through 47218); the FY 2009 IPPS proposed rule (73 FR 23547), and final
rule (73 FR 48471); and the FY 2010 IPPS/RY 2010 LTCH PPS proposed rule
(74 FR 24106) and final rule (74 FR 43782). A complete list of the 10
current categories of HACs is included in section II.F.2.of FY 2011
IPPS/RY 2011 LTCH PPS (75 FR 50080 through 50101).
POA coding is also used in the specifications for the component
indicators for the AHRQ Patient Safety composite measure we proposed to
adopt for the Hospital VBP program for FY 2014. This composite measure
consists of 8 component indicators, including PSI-3 (Pressure ulcer),
PSI-6 (Iatrogenic Pneumothorax), PSI-7 (Central venous catheter-related
bloodstream infections), PSI-8 (Postoperative hip fracture), PSI-12
(Postoperative pulmonary embolism or
[[Page 26505]]
deep vein thrombosis), PSI-13 (Postoperative sepsis), PSI-14
(Postoperative wound dehiscence), and PSI-15 (Accidental Puncture or
Laceration). For each of these component indicators, present-on-
admission coding is one of the exclusion criteria used to indicate
whether a condition or an injury occurred before or after the patient
was admitted to the hospital. Please refer to
www.qualityindicators.ahrq.gov for further details about the technical
specifications for these measures. We are using the POA information on
the final adjudicated claim submitted by the hospital. These data are
subject to the same scrutiny as other information on Medicare claims.
We also note that we are currently evaluating the Hospital Acquired
Condition-Present on Admission (HAC-POA) Program. We appreciate the
commenters' interest and will take it into consideration as we proceed
with this evaluation.
Comment: Some commenters noted that the proposed HAC measures are
limited to the Medicare fee-for-service population and suggested that
these measures should not be used in Hospital VBP.
Response: The proposed HAC measures are calculated using only
Medicare fee-for-service data because we do not currently have access
to claims data that is submitted by hospitals to other payers. We also
note that POA codes, which are required to calculate all of the
proposed HAC measures and which must be included on Medicare Part A
claims submitted to CMS by hospitals, may not be required to be
included on inpatient claims submitted by hospitals to other payers.
Despite this data limitation, we believe that the proposed HAC measures
provide important information regarding patient safety events occurring
during hospitalization, which reflect the quality of patient care
provided, and we believe these measures should be included in the
Hospital VBP program.
Comment: Some commenters questioned whether value-based incentive
payments will be available only to Medicare FFS and Medicare cost
payers and not Medicare Advantage Organization (MAO) payers.
Response: Value-based incentive payments made under the Hospital
VBP program can be made only in the form of an adjustment to a
subsection (d) hospital's base operating DRG payment amount under the
IPPS.
Comment: Some commenters noted that the proposed HAC measures do
not capture more than 9 diagnoses.
Response: CMS' current system limitations allow for the processing
of only the first 9 diagnoses and 6 procedures. While CMS accepts all
25 diagnoses and 25 procedures submitted on the claims, we do not
process all of the codes because of these system limitations.
In the FY 2011 IPPS/LTCH-PPS final rule, we discussed our plans to
accept and process up to 25 diagnoses and procedures on the hospital
inpatient claims submitted on the 5010 format beginning January 1, 2011
(75 FR 50127 through 50128). In the FY 2010 IPPS/RY 2010 LTCH PPS final
rule, we responded to hospitals' requests that we process up to 25
diagnosis codes and 25 procedure codes (74 FR 43798). In that FY 2010
IPPS/RY 2010 LTCH PPS final rule, we referred readers to the ICD-10
final rule (74 FR 3328 through 3362) where we discuss the updating of
Medicare systems prior to the implementation of ICD-10 on October 1,
2013. We mentioned that part of the system updates in preparation for
ICD-10 is the ``expansion of our ability to process more diagnosis and
procedure codes.'' In the FY 2009 IPPS final rule (73 FR 48433 through
48444), we also responded to multiple requests to increase the number
of codes processed from 9 diagnosis and 6 procedure codes to 25
diagnosis and 25 procedure codes.
We are currently making extensive system updates as part of the
move to 5010, which includes the ability to accept ICD-10 codes. This
complicated transition involves converting many internal systems prior
to October 1, 2013, when ICD-10 will be implemented. One important step
in this planned conversion process is the expansion of our ability to
process additional diagnosis and procedure codes. We are currently
planning to complete the expansion of this internal system capability
so that we are able to process up to 25 diagnoses and 25 procedures on
hospital inpatient claims as part of the HIPAA ASC X12 Technical
Reports Type 3, Version 005010 (Version 5010) standards system update.
Comment: Many commenters recommended that CMS develop risk
adjustment methods, measure exclusion criteria, or stratified scoring
methods to account for variations in measure rates related to patient
factors or hospital function. Commenters argued that many of the
proposed outcome, patient experience, and other measures including
HCAHPS, HACs, and mortality measures are not valid because they lack
appropriate risk adjustment and exclusion criteria and called for their
exclusion from the Hospital VBP program. One commenter suggested risk
adjustments should specifically be employed for trauma patients. A
number of commenters suggested that CMS consider other risk adjustment
models used by the industry, such as those promulgated by the Society
of Thoracic Surgeons. One commenter suggested that we include ``median
income of ZIP code of residence'' in a risk adjustment methodology for
mortality measures in order to account for socioeconomic variables that
may lead to a greater rate of mortality. Additionally, some commenters
suggested that CMS convene experts to develop a ``population
adjustment'' and adopt only HACs that do not rely on claims data for
the Hospital VBP program.
Response: For the measures that currently employ risk adjustment,
we are using the risk adjustment models that are part of the NQF-
endorsed measure specifications. In developing its risk adjustment
model for the 30-day measures, the NQF performed an extensive
literature review of risk factors employed by other models to inform
the development of its model. We note that the current risk adjustment
methodology for the three proposed mortality measures for FY 2014 was
recently reevaluated and approved by an NQF steering committee. There
is no risk adjustment for race and socioeconomic status, which we
believe is appropriate because we do not want to hold hospitals with
different racial or SES mixes to different performance standards.
Adjusting for race or SES would also obscure differences that are
important to identify if we want to reduce disparities where they do
exist. We note that the NQF has issued guidance recommending against
adjusting for patient characteristics such as socioeconomic status in
outcomes measures, located at: http://www.qualityforum.org/docs/measure_evaluation_criteria.aspx. We welcome collaboration on this
issue with providers that serve unique patient populations and
functions.
Furthermore, while we understand that claims-based measures such as
HAC measures have certain limitations, as discussed below, HAC measures
were defined in prior rulemaking, during which we conducted several
listening sessions and had the benefit of receiving public comment. We
note that some of the HACs are ``never'' events and therefore should
not be risk adjusted. We will consider refinements to the HAC measures
in future years. We will monitor the impact of the Hospital VBP program
on the care provided to
[[Page 26506]]
vulnerable subpopulations of patients, including trauma patients.
Comment: Some commenters argued that the proposed HAC measures
should be risk-adjusted before they are used in Hospital VBP.
Response: Six of the 8 HACs adopted for the Hospital VBP program
are considered ``never events,'' for which risk adjustment would not be
appropriate because, in our view, such events should never happen under
any circumstances. In the event that we do decide that some type of
risk adjustment would be appropriate, we will seek input from the NQF
as to whether or not this constitutes a substantive change to the
measures, in which a formal consensus development process will be
initiated. We will consider further refinements to the HAC measures in
future years. We note that when we adopted the HAC vascular catheter-
associated infection measure and the catheter-associated urinary tract
infection measure in the FY 2008 IPPS final rule with comment period
(72 FR 47202 through 47218), there were no related risk-adjustments
under the DRG payment policy reforms (72 FR 47141).
Comment: Some commenters suggested that measures should be approved
by the Hospital Quality Alliance (HQA) before use in the Hospital VBP
program.
Response: In developing the Hospital VBP program, we took into
account the input of a multitude of stakeholders, including the HQA.
The HQA is a national, public-private collaboration committed to making
meaningful, relevant, and easily understood information about hospital
performance accessible to the public and to informing and encouraging
efforts to improve quality. We will also continue to consider HQA input
as part of our ongoing measure selection process for the Hospital VBP
program.
Comment: Some commenters argued that the low incidence rates of
HACs, particularly in academic medical centers, would lead to unstable
statistics on which to base comparisons between hospitals.
Response: Low incidence of events does not equate to unstable rates
for those events. We acknowledge that the rates of some of the HACs,
particularly the ones measuring `never events', may be rare. However,
because these are considered events that should never happen, reporting
their prevalence, though rare, is still meaningful. We have not found
that HAC incidence is particularly low in academic medical centers. We
believe that all of the proposed HAC measures are important to measure
and report, despite their low incidence rates, and that the public
reporting of the HACs on the Hospital Compare Web site will encourage
improvement. We believe that the Hospital VBP program must emphasize
patient safety and improved quality of health care, and we believe that
holding hospitals accountable for HACs will further those goals.
Comment: Some commenters asked us to discuss the inclusion of HAIs
in HACs. Specifically, the commenters asked us to include additional
detail on how CMS plans to implement HHS's HAI Action Plan.
Response: Two of the eight proposed HAC measures (Vascular
Catheter-Associated Infection and Catheter-Associated Urinary Tract
Infection) capture HAIs. We are considering the feasibility of
proposing to adopt all of the metrics listed in the HAI Action Plan for
the Hospital IQR program in future years. In the FY 2011 IPPS/LTCH PPS
final rule, we adopted two of the HAI measures from the HHS HAI Action
Plan: the central line-associated bloodstream infection measure, for
which reporting began with respect to January 2011 events; and the
surgical site infection measure, which hospitals will begin reporting
with respect to January 2012 events. In addition, we have proposed in
the FY 2012 IPPS/LTCH PPS proposed rule scheduled for publication on
May 5, 2011, to adopt additional HAI measures: Catheter-associated
urinary tract infection measure, central line insertion practices
adherence percentage; Methicillin-resistant Staphylococcus aureus
(MRSA), Clostridium difficile (C-Diff), and Health Care Personnel
Influenza Vaccination measures. All of these measures, if finalized for
the Hospital IQR program, will be eligible for inclusion in the
Hospital VBP program, and would allow CMS to better address the
important topic area of Healthcare Associated Infections.
Comment: Some commenters noted that HACs are not entirely
preventable and argued that they should not be a component of quality
measurement.
Response: We believe that all 8 proposed HAC measures assess the
presence of hospital acquired conditions that are reasonably
preventable if high quality care is furnished to the patient. We also
believe that the incidence of HACs in general raise major patient
safety issues for Medicare beneficiaries. According to the 2010
Department of Health and Human Services Office of the Inspector General
Report, entitled ``Adverse Events in Hospitals: National Incidence
among Medicare Beneficiaries,'' an estimated 13.5 percent of
hospitalized Medicare beneficiaries experienced adverse events during
their hospital stays (OIG, November 2010, OEI-06-09-00090). We proposed
to adopt 8 HAC measures for the Hospital VBP program because they are
outcome measures (which are widely regarded by the provider community
as strongly indicative of quality of medical care) that assess whether
certain adverse events occurred during hospitalization. We believe that
the adoption of these measures will facilitate our on-going efforts to
hold hospitals accountable for these events, as well as reduce the
incidence of these adverse events that result in harm to Medicare
beneficiaries and higher costs of care.
Comment: Some commenters asked us to explain why HACs are
appropriate for quality measurement and scoring given that they are
derived from billing and payment methods.
Response: We believe that public reporting of the HACs on the
Hospital Compare Web site will encourage improvement. We acknowledge
that the incidence of HACs may be rare. However, many of the HACs are
considered events that should never happen; reporting their prevalence,
though rare, is still meaningful.
Medicare fee for service claims data is the source for many
measures that are NQF endorsed. This data source was reviewed as part
of the NQF endorsement process for such measures, and has been found to
be an appropriate data source. We also refer readers to the FY 2008
IPPS final rule with comment period (72 FR 47202 through 47218);
section II.F. of the FY 2009 IPPS final rule with comment period (73 FR
48474 through 48486); and section II.F. of the FY 2010 IPPS/RY 2010
LTCH PPS final rule (74 FR 43782 through 43785) for detailed
discussions regarding the selection of the current 10 HAC categories.
Comment: Some commenters suggested that CMS consider integrating
HACs, complications and other causes of waste into an efficiency domain
rather than in clinical process or outcomes.
Response: We believe that the proposed HAC measures best capture
health care quality outcomes rather than efficiency and are therefore
best included in the outcome domain.
Comment: One commenter suggested that we revise the definition of
Falls and[?] Trauma. Specifically, the commenter suggested that the
definition should be revised to require not only these injury codes,
but also an e-code related to falls that are not POA.
Response: We appreciate the suggestion to refine the definition of
this
[[Page 26507]]
HAC, and will consider refinements for future implementation.
Comment: Some commenters requested that we provide detailed measure
specifications for the proposed HAC measures immediately if we intend
to use them in the Hospital VBP program.
Response: The specifications for these proposed measures were made
available on QualityNet at http://www.qualitynet.org earlier in the
year.
Comment: Some commenters were opposed to the use of Nursing
Sensitive measures in the Hospital VBP measure set while others, noting
that nurses provide numerous services to patients, argued that nursing
sensitive measures are essential quality indicators.
Response: We agree that nurses provide numerous services to their
patients, and we are interested in nursing sensitive measures because
those measures capture many processes and outcomes that are influenced
by nursing practice. Currently, we only have one nursing sensitive
measure in the Hospital IQR Program: Death among surgical inpatients
with serious treatable complications (AHRQ PSI-04). We are also
collecting the structural measure ``Participation in a Systematic
Clinical Database Registry for Nursing Sensitive Care''. We will
consider adopting one or more measures in the nursing sensitive
category for the Hospital IQR and Hospital VBP programs in the future.
Comment: Some commenters opposed the use of any AHRQ PSI and IQI
measures or their composites in Hospital VBP. Others suggested that
those measures should be evaluated for validity and reliability as they
were not developed to be performance measures and are based on claims
data. Others noted that hospitals have encountered technical and
programming issues with respect to the proposed AHRQ measures.
Response: We thank commenters for their input. The AHRQ PSI and IQI
measures that we proposed to adopt for the Hospital VBP measure set are
NQF endorsed. In order to achieve NQF endorsement, measures must meet
all of the criteria of the NQF consensus development process.
Information on this process can be found at: http://www.qualityforum.org/Measuring_Performance/Consensus_Development_Process.aspx. We believe this consensus development process includes
the necessary steps to assure that measures that are NQF endorsed have
been tested for validity and reliability of the data. This endorsement
includes the data source needed to calculate the measures (Medicare fee
for service claims). We believe these measures are appropriate for use
in the Hospital VBP program as they meet the statutory requirements for
inclusion and address the topic of patient safety, which is a high
priority that we believe should be addressed in the Hospital VBP
program. We also note that because these measures are claims-based, no
separate data reporting is needed.
Comment: One commenter objected to the use of PSI 4, arguing that
about 25 percent of surgical patients are admitted with sepsis or acute
illness and multiple organ failure for surgical exploration, then coded
as surgical patients even if the surgery doesn't find anything and
doesn't contribute to death.
Response: We have not proposed to adopt PSI 4, Death among surgical
inpatients with serious, treatable complications, for inclusion in the
Hospital VBP program. However, we note that the specifications for that
measure specifically exclude patients with a diagnosis of sepsis or
infection in the primary diagnosis field and patients who are
immunosuppressed.
Comment: Some commenters argued that the proposed AHRQ measures
amount to double-counting for purposes of scoring, as two of the
proposed AHRQ measures are composites of the other AHRQ measures.
Response: We appreciate commenters' concerns. We agree that the use
of all of the proposed AHRQ measures, including the two composite
measures, would result in ``double-counting'' each of the individual
measures. While each of the individual AHRQ measures capture important
components of quality care, we believe that scoring hospital
performance on the two composite measures simply and clearly captures
the provision of high quality care that we wish to incentivize in the
Hospital VBP program. Therefore, we are only finalizing the 2 proposed
AHRQ composite measures, which will avoid any double-counting.
Comment: Some commenters argued that all outcome, process, and
patient experience measures should be posted on Hospital Compare for
one year prior to use in the Hospital VBP program, and that, during
this year, CMS should provide quarterly hospital preview reports on
qualitynet.org with a percentile ranking for each measure in order to
prepare for public reporting.
Response: In accordance with statutory requirements, all measures
will be included on Hospital Compare for at least one year prior to the
beginning of the performance period for which we propose to adopt them
under the Hospital VBP program. The process of care measures and HCAHPS
are updated quarterly, and facilities that submit data are provided a
30-day preview of their data before public reporting occurs. The
outcomes of care measures are updated annually, usually in July. The
new outcomes data is included in the preview reports for this display
period. As stated below, we will provide details on the information to
be reported on Hospital Compare in future rulemaking. We will consider
commenters' suggestion for quarterly preview reports on qualitynet.org
before public reporting. However, we believe that providing robust
quality information to the public as soon as possible is a desired
outcome of quality reporting and performance scoring.
Comment: One commenter noted that the requirement that measures be
included on Hospital Compare appears to be a significant barrier to
timely adoption of the HAI Action Plan metrics in the Hospital VBP
program. Other commenters encouraged us to accelerate the adoption of
those metrics for the Hospital IQR program, Hospital Compare, and NQF
endorsement.
Response: We agree that the requirement that measures be included
on the Hospital Compare Web site for at least one year before the
performance period for them can begin under the Hospital VBP program
has the potential to limit the speed at which we can adopt measures for
the program, however we intend to propose to adopt measures that drive
quality improvements and improve patient safety, such as the prevention
metrics included in the HHS Action Plan to Prevent HAIs, as quickly as
possible within that constraint.
Comment: Some commenters argued that CMS's data collection system
does not adequately differentiate among conditions acquired in the
hospital and those that are ``present on admission'' (POA) for purposes
of scoring outcome measures. Commenters recommended that CMS allow
hospitals to use POA claims indicators or consider other methods for
outcome measure scoring, particularly since certain types of hospitals
such as trauma centers or tertiary referral centers could be penalized
on those measures because they receive a disproportionate share of
transfers from other hospitals. Some commenters suggested that
transferee and transferor hospitals should share in mortality rates for
transferred patients.
Response: We are currently using the POA indicator to calculate the
proposed HAC and AHRQ patient safety composite measures, and we believe
that the use of this indicator will better enable us to identify
patient safety events, conditions and complications arising during
hospital stays. We also
[[Page 26508]]
note that, under the specifications for the 30-day mortality measures,
if the primary discharge diagnosis at the receiving hospital matches
the primary discharge diagnosis at the transferring hospital, the
patients are included in the transferring hospital's mortality measure
calculations. We believe this approach encourages coordination between
hospitals and their referral networks. Further, we believe that this
approach promotes the best interests of the patient because it does not
create an incentive for hospitals to transfer patients who are
critically ill or at high risk of dying.
Comment: Some commenters were concerned about the accuracy of
claims-based quality measures. In particular, they questioned how
claims-based quality measurements will be accurate given hospitals'
technical and programming issues with the AHRQ measures, which are
claims based rather than chart abstracted.
Response: Both the AHRQ measures and their data source have been
endorsed by NQF. We note that other quality initiatives, such as the
Medicare End-Stage Renal Disease Quality Incentive Program, require
reporting on claims-based measures. While they have certain
limitations, claims-based measures provide important information on
hospital quality of care. We also note that hospitals are not required
to submit data for the AHRQ measures; rather, the calculations are
derived from Medicare fee-for-service claims data. Thus, neither
technical nor programming issues should arise. For the reasons
discussed above, we are only finalizing the two composite AHRQ
measures.
Comment: Some commenters opposed our proposal to implement a
subregulatory process for adding or retiring measures, calling on CMS
to use full notice and comment rulemaking instead. A few commenters
supported the proposed subregulatory process.
Response: We appreciate the comments, and understand that
stakeholder input is critical to ensuring that the Hospital VBP program
and measure set improves the quality of care and patient safety. As
stated in the Hospital Inpatient VBP proposed rule (76 FR 2458 through
2459), we believe that we 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\
---------------------------------------------------------------------------
\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.
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For this reason, we believe that we should 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. Additionally, we believe that we should retire measures from
the Hospital VBP program as quickly as possible to ensure that they do
not detract from other measures that we believe will be more impactful
in improving patient health. We believe that speed of implementation is
a critical factor in the success and effectiveness of this program.
However, we are aware of stakeholders' concerns about the proposed
subregulatory process. We understand commenters' point that notice-and-
comment rulemaking is important to ensure that hospitals are aware of
the applicable measures. In response to those comments, we will not
finalize the proposed subregulatory process for adding or retiring
measures. Instead, we have proposed in the FY 2012 IPPS/LTCH PPS
proposed rule scheduled for publication on May 5, 2011 that we might
choose to propose to simultaneously adopt one or more measures for both
the Hospital IQR Program and the Hospital VBP program. We refer readers
to that proposal for further information.
Comment: Some commenters suggested that we consider adopting
quality measures covering more conditions to ensure that hospitals
improve the quality of care that they furnish to all patients, not just
those diagnosed with conditions covered by current quality measures.
Response: We thank commenters for the suggestion. The Affordable
Care Act specifically names AMI, HF, PN, SCIP, HAIs and HCAHPS as
initial topics to be included in the Hospital VBP program in FY 2013.
We will consider other measures and conditions for inclusion in the
Hospital VBP program for future years.
Comment: Some commenters strongly opposed use of the IQI stroke
mortality measure, arguing that it is not adjusted for stroke severity.
Response: We thank commenters for their suggestion. The current
methodology for this measure, including the risk adjustment methodology
is NQF endorsed.
Comment: A number of commenters asked how hospitals will be scored
and payments will be adjusted when measure specifications change.
Response: We understand that from time to time measure
specifications require updating. We maintain the technical
specifications by updating the 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. While many of these updates or
changes do not impact the calculation of the measures, we are aware
that substantive changes to the specifications for a measure may impact
the score a hospital receives.
Comment: Some commenters asked if measure adoption will expand at a
rate that keeps pace with hospital resources. Other commenters
expressed concern that measure reporting might burden hospitals, while
others suggested that we consider how difficult measures are for
hospitals to improve upon.
Response: We are cognizant of the reporting burden on hospitals
associated with the adoption of new measures under both the Hospital
IQR program and the Hospital VBP program. In proposing to adopt new
measures for the Hospital IQR program, which make them candidates for
the Hospital VBP program, we have emphasized on many occasions that we
take into consideration the burden that additional reporting will have
on hospitals, and we seek, for that reason, to limit our proposals to
adopt chart-abstracted measures. We also carefully consider whether the
benefit that we believe will be realized from adopting additional
measures (such as encouraging hospitals to improve their performance on
those measures) will outweigh the burden associated with their
collection.
Comment: Some commenters asked if 30-day readmission rates will be
included in the Hospital VBP program.
Response: Measures of readmissions are statutorily excluded under
section 1886(o)(2)(A) of the Act and therefore cannot be included in
the Hospital VBP program.
Comment: A commenter asked if measure scores will be based on all-
payer data or Medicare data only. Some commenters argued that the
Hospital VBP program's measures should capture data for all patients,
not Medicare patients only so that hospitals are ranked and
incentivized according to their care for all patients, rather than for
Medicare patients only.
Response: Measures in the clinical process and patient experience
domains are scored using all-patient data while measures in the outcome
domain will be scored using Medicare claims data only. Although we
generally agree that all-patient data would be a preferable
[[Page 26509]]
source of data for purposes of calculating all Hospital VBP measures,
we currently do not have access to claims data submitted by hospitals
to other payers.
Comment: Some commenters suggested that we more forcefully endorse
the NQF process, expressing concern that marginalizing the NQF
endorsement process might discourage hundreds of hard working
volunteers.
Response: We work closely with the NQF on issues related to measure
endorsement because that entity holds the contract under section
1890(a) of the Act. However, we note that in the case of a specified
area or medical topic determined appropriate by the Secretary for which
there is no NQF-endorsed measure, section 1886(b)(3)(B)(viii)(IX)(bb)
of the Act allows us to specify a measure that is not NQF-endorsed so
long as due consideration has been given to measures that have been
endorsed or adopted by a consensus organization identified by the
Secretary.
Comment: Several commenters suggested that we consider adopting a
central line-associated blood stream infections measure, a surgical
site infections measure, and/or the National Database of Nursing
Quality Indicators for the Hospital VBP program.
Response: We thank commenters for their input. We note that we have
adopted a central line-associated blood stream infection measure
(CLABSI) and surgical site infection measure (SSI) for the Hospital IQR
program, and we anticipate proposing to adopt these measures for the
Hospital VBP program in the future. The National Database of Nursing
Quality Indicators (NDNQI) were previously considered for Hospital IQR
program adoption (See 72 FR 47351), and we remain interested in these
measures.
Comment: Some commenters asked us to explain why the current
requirement by CMS for NHSN reporting begins with January 2011 events
for CLABSI and with January 2012 events for SSI.
Response: In response to public comments on the FY 2011 IPPS/LTCH
PPS proposed rule, we adopted one NHSN collected measure (the CLABSI
measure) for the FY 2013 Hospital IQR payment determination (with
reporting beginning with respect to January 2011 events) to allow
hospitals to gain experience with the NHSN collection mechanism for one
year before requiring hospitals to begin reporting a second measure
(SSI) using that mechanism (75 FR 50202).
Comment: Some commenters argued that the FY 2013 measures do not
reflect nurses' contributions to patient care.
Response: We disagree. Many of the process of care measures reflect
the contributions of a broad range of healthcare professionals,
including nurses. Furthermore, a number of measures rely heavily on
nursing input and documentation. Additionally, one of the eight HCAHPS
dimensions focuses exclusively on nurses' role in communicating with
patients regarding their care.
Comment: One commenter suggested that we post measure information
on Hospital Compare for 2 years prior to adopting them in the Hospital
VBP program.
Response: We thank the commenter for the input. Although we
acknowledge that section 1886(o)(2)(C)(i) provides, in part, that
measures must be included on the Hospital Compare Web site for at least
one year prior to the performance period, we believe that a one year
period is sufficient to ensure that hospitals, Medicare beneficiaries
and other stakeholders are fully aware of and familiar with the
measures before they are added to the Hospital VBP program. We also
believe that any further delay would unnecessarily postpone the
adoption of important measures for the Hospital VBP program.
Comment: One commenter noted that care coordination measures are
not included in the Hospital VBP measure set.
Response: We will consider this comment as we seek to expand the
Hospital VBP measure set in the future.
Comment: One commenter called on us not to use the Krumholtz
methodology for mortality measures. The commenter noted that this
methodology has only been applied in very narrow ranges of diagnoses;
may not be useful for comparing mortality rates; has weak explanatory
power; omits variables that should be considered; and would be
difficult if not impossible to generalize.
Response: We disagree. The risk-standardized mortality rates for
the three proposed mortality measures are derived from administrative
data for Medicare patients with a principal discharge diagnosis of AMI,
HF, and PN from all acute care and critical access hospitals in the
nation. The model used for calculation includes several variables and
has a relatively high discrimination rate. As a result we believe this
methodology is appropriate to use. Additionally, this methodology falls
within the scope of the NQF-endorsement for the three proposed
mortality measures.
Comment: One commenter asked us to clarify whether hospital data
reported on Hospital Compare that are also collected by the Joint
Commission will continue to be included on Hospital Compare.
Response: Yes. Many of the AMI, Heart Failure, Pneumonia and SCIP
measures reported to CMS for Hospital IQR and publicly reported on
Hospital Compare are also collected and utilized by the Joint
Commission. In addition, hospitals can voluntarily choose to allow CMS
to publicly report the Joint Commission's children's asthma care
measures, which are not part of Hospital IQR, on Hospital Compare. We
will continue to publicly report all Hospital IQR measures and other
quality information on Hospital Compare.
Comment: One commenter questioned whether the proposed clinical
process of care measures have been tested in older patients and women
to assure applicability to Medicare's patient subpopulations.
Response: The clinical process of care measures proposed for the
Hospital VBP program have been tested and used in all patients 18 years
and older which includes older patients and women if they meet criteria
for inclusion in the measure.
Comment: Some commenters recommended that CMS and outside experts
study the measures' actual impact on patients and caregivers.
Commenters also expressed concern about possible unintended
consequences for patient care due to measure design, such as some
hospitals refusing to admit high-risk patients in an effort to improve
their Total Performance Score.
Response: We thank commenters for their input. We intend to monitor
the initial impacts of the Hospital VBP program, including its impacts
on costs, quality, outcomes, and patient experiences with care. We
believe the Hospital VBP program represents a significant next step in
aligning payment with the quality of care delivered to beneficiaries.
We firmly believe that these efforts will increase the quality of care
provided, resulting in improved health outcomes. However, we will
monitor and evaluate the impact of the Hospital VBP program on access
to and quality of care, including monitoring any unintended
consequences.
Comment: One commenter stated that the proposal to use electronic
submission for measures in future years was misaligned with one of the
potential future measures. The measure, ``median time from admit
decision time to time of departure from the emergency department (ED)
for ED patients admitted to inpatient status'' differs from the
specifications put forth by
[[Page 26510]]
HITSP (Health Information Technology Standards) which specifies the
measure as, Admit Decision Time to ED Departure Time. The difference is
that the former does not allow for the use of Admit Orders Date (or
Admit Orders Time) in the measures specification while the HITSP
specifications do allow the use of this data.
Response: We agree that the measure specifications for ``median
time from admit decision time to time of departure from the emergency
department (ED) for ED patients admitted to inpatient status'' require
manual chart abstraction, and is specified slightly different than
electronic health record version of the measure. This is because of the
availability of the data. When abstracting data manually, a human
abstractor uses specific guidelines for abstraction. Admit order date/
time are not included in the chart abstracted version as the intent of
the measure is to calculate throughput time (that is, how long the
patient is in the ED) which is calculated from admit decision to
departure from the Emergency Department. The admit decision time is
generally found in a note written in the chart, and therefore, a human
abstractor can interpret that data element per the guidelines for
abstractions. In contrast, admit date/time are used in the electronic
specifications as the two fields are readily available in the
electronic health record (EHR), and there is no human interpretation.
At this time, data from a progress note is not considered a discreet
data element and therefore cannot be used for EHR abstraction.
After consideration of public comments, we are finalizing our
proposed definition of ``topped out'' for purposes of measure selection
under the Hospital VBP program. We will use this definition to inform
our measure proposals for future Hospital VBP program years and will
use the most recently available data at the time to conduct our
analysis. Additionally, we are finalizing our proposal to adopt 12 of
the 17 proposed clinical process of care measures for the FY 2013
Hospital VBP program, but for the reasons discussed above, are not
finalizing our proposal to adopt the following measures: PN-2, PN-7,
AMI-2, HF-2 and HF-3.
Table 2 lists the 13 measures we are finalizing for the FY 2013
Hospital VBP measure set.
Table 2--Final Measures for FY 2013 Hospital VBP Program
------------------------------------------------------------------------
Measure ID Measure description
------------------------------------------------------------------------
Clinical Process of Care Measures
------------------------------------------------------------------------
Acute myocardial infarction
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
Pneumonia
------------------------------------------------------------------------
PN-3b............................. Blood Cultures Performed in the
Emergency Department Prior to
Initial Antibiotic Received in
Hospital.
PN-6.............................. Initial Antibiotic Selection for CAP
in Immunocompetent Patient.
------------------------------------------------------------------------
Healthcare-associated infections
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
Surgeries
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
Patient Experience of Care Measures
------------------------------------------------------------------------
HCAHPS............................ Hospital Consumer Assessment of
Healthcare Providers and Systems
Survey.\5\
------------------------------------------------------------------------
With respect to the FY 2014 Hospital VBP measure set, we are
finalizing our proposal to adopt the three 30-day mortality claims-
based measures, MORT-30-AMI, MORT-30-HF, and MORT-30-PN, as well as the
8 proposed HAC measures. In light of the public comments we received
regarding the proposed AHRQ measures and as discussed above, we are
only finalizing the 2 composite measures: Complication/patient safety
for selected indicators (composite) and Mortality for selected medical
conditions (composite). The measures that we are finalizing in this
final rule for the FY 2014 Hospital VBP Program are listed in Table 3
below.
---------------------------------------------------------------------------
\5\ Proposed dimensions of the HCAHPS survey for use in the FY
2013 Hospital VBP program are: Communication with Nurses,
Communication with Doctors, Responsiveness of Hospital Staff, Pain
Management, Communication about Medicines, Cleanliness and Quietness
of Hospital Environment, Discharge Information and Overall Rating of
Hospital.
[[Page 26511]]
Table 3--Finalized Outcome Measures for the FY 2014 Hospital VBP Program
------------------------------------------------------------------------
------------------------------------------------------------------------
Mortality Measures (Medicare Patients):
Acute Myocardial Infarction (AMI) 30-day mortality rate..
Heart Failure (HF) 30-day mortality rate.................
Pneumonia (PN) 30-day mortality rate.....................
AHRQ Patient Safety Indicators (PSIs), Inpatient Quality Indicators
(IQIs) Composite Measures:
Complication/patient safety for selected indicators
(composite)......................................................
Mortality for selected medical conditions (composite)....
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 Infection...................
Catheter-Associated Urinary Tract Infection (UTI)........
Manifestations of Poor Glycemic Control..................
------------------------------------------------------------------------
As noted above, we have proposed in the FY 2012 IPPS/LTCH PPS
proposed rule scheduled for publication on May 5, 2011 to adopt an
additional measure, Medicare spending per beneficiary, for the FY 2014
Hospital VBP program. We also intend to propose to adopt additional
measures for the FY 2014 Hospital VBP program in the CY 2012 OPPS
proposed rule.
E. Performance Standards
To determine what the performance standard for each proposed
clinical process of care measure and the 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 had on each of these
measures by virtue of the Hospital IQR program. Because we proposed to
adopt a performance period that was less than a full year for FY 2013,
we were sensitive to the fact that hospital performance on the proposed
measures could 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 time period in the
applicable 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 stated
our belief that selecting a three-quarter baseline period from July 1,
2009 to March 31, 2010 will enable us to achieve this goal. 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.
We proposed to set the achievement performance standard
(achievement threshold) for each proposed FY 2013 Hospital VBP measure
at the median of hospital performance (50th percentile) during the
baseline period of July 1, 2009 through March 31, 2010. As proposed in
the Hospital Inpatient VBP proposed rule (76 FR 2463 through 2464),
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 and will reward hospitals for meritorious performance on
quality measures. We also proposed to set the improvement performance
standard (improvement threshold) for each measure at each specific
hospital's performance on the measure during the baseline period of
July 1, 2009 through March 31, 2010. We believe that these proposed
improvement performance standards ensure that hospitals will be
adequately incentivized to improve.
We proposed to set the achievement performance standard
(achievement threshold) for each of the proposed FY 2014 Hospital VBP
mortality measures at the median of hospital performance (50th
percentile) during the baseline period. We proposed to set the
improvement performance standard (improvement threshold) for each
mortality measure at each specific hospital's performance on each
measure during the baseline period of July 1, 2008 to December 31,
2009. The comments we received on these proposals and our responses are
set forth below.
Comment: A number of commenters suggested that we publish baseline
achievement thresholds and benchmarks for clinical process measures and
HCAHPS dimensions on Hospital Compare.
Response: The finalized achievement thresholds and benchmarks that
apply to the FY 2013 Hospital VBP program are provided in Table 4 of
this final rule. We will consider the commenters suggestion to publish
baseline achievement thresholds and benchmarks on Hospital Compare in
the future.
Comment: One commenter requested that CMS clarify whether hospitals
lacking the minimum number of patients or measures would be included in
baseline period calculations of thresholds and benchmarks.
Response: The achievement thresholds and benchmarks will be
calculated using data from a baseline period comparable in length to
the performance period. For this reason, we believe that we should also
use the same minimums for purposes of those calculations.
Comment: One commenter suggested that we compare performance among
similar hospitals rather than against
[[Page 26512]]
national data. Other commenters asked if CMS was going to adjust the
baseline period data based on any factors such as geographic region.
Response: We believe that achievement thresholds and benchmarks
based on national data provide balanced, appropriate standards of high
quality care for hospitals to work towards under the Hospital VBP
program. Some groups of hospitals may perform better or worse than
other hospitals on certain measures, but we do not believe it would
appropriate to raise or lower the performance standards based on such
observations. For example, we do not wish to lower the performance
standards for a hospital simply because average performance in its
local region is subpar compared to national performance. Similarly, we
do not wish to raise or lower the performance standards for large
hospitals, teaching hospitals, or others based on any observations that
classes of hospitals differed in their average performance on
individual measures. We note that consumers will be able to compare
geographically and demographically similar hospitals' performance on
measures as they currently do on the Hospital Compare Web site.
Comment: One commenter asked us to clarify the baseline periods for
Hospital VBP program years after FY 2013.
Response: We intend to propose all future baseline periods in
future rulemaking and specifically, intend to propose the FY 2014
Hospital VBP payment determination baseline period in the CY 2012 OPPS
rule.
Comment: One commenter asked how CMS will address hospital mergers
that occur during the performance period.
Response: The issue of how to address the calculation of the total
performance score in the context of hospital mergers will be the
subject of future rulemaking.
After considering the public comments, we are finalizing the
proposed definitions of the achievement performance standard
(achievement threshold) and the improvement performance standard
(improvement threshold) for the FY 2013 Hospital VBP program as
displayed below in Table 4. Because our process for validating the
proposed baseline period of data was not yet complete at the time we
issued the proposed rule, we were unable to provide the precise
achievement threshold values; instead we provided example achievement
performance standards. We also stated that these values would be
specified in the final rule (76 FR 2464), and they are shown below.
Table 4--Achievement Thresholds That Apply to the FY 2013 Hospital VBP
Program Measures
------------------------------------------------------------------------
Performance
standard
Measure ID Measure description (achievement
threshold)
------------------------------------------------------------------------
Clinical Process of Care Measures
------------------------------------------------------------------------
AMI-7a......................... Fibrinolytic Therapy 0.6548
Received Within 30
Minutes of Hospital
Arrival.
AMI-8a......................... Primary PCI Received 0.9186
Within 90 Minutes of
Hospital Arrival.
HF-1........................... Discharge Instructions. 0.9077
PN-3b.......................... Blood Cultures 0.9643
Performed in the
Emergency Department
Prior to Initial
Antibiotic Received in
Hospital.
PN-6........................... Initial Antibiotic 0.9277
Selection for CAP in
Immunocompetent
Patient.
SCIP-Inf-1..................... Prophylactic Antibiotic 0.9735
Received Within One
Hour Prior to Surgical
Incision.
SCIP-Inf-2..................... Prophylactic Antibiotic 0.9766
Selection for Surgical
Patients.
SCIP-Inf-3..................... Prophylactic 0.9507
Antibiotics
Discontinued Within 24
Hours After Surgery
End Time.
SCIP-Inf-4..................... Cardiac Surgery 0.9428
Patients with
Controlled 6AM
Postoperative Serum
Glucose.
SCIP-VTE-1..................... Surgery Patients with 0.9500
Recommended Venous
Thromboembolism
Prophylaxis Ordered.
SCIP-VTE-2..................... Surgery Patients Who 0.9307
Received Appropriate
Venous Thromboembolism
Prophylaxis Within 24
Hours Prior to Surgery
to 24 Hours After
Surgery.
SCIP-Card-2.................... Surgery Patients on a 0.9399
Beta Blocker Prior to
Arrival That Received
a Beta Blocker During
the Perioperative
Period.
------------------------------------------------------------------------
Patient Experience of Care Measures
------------------------------------------------------------------------
HCAHPS......................... Communication with 75.18%
Nurses.
Communication with 79.42%
Doctors.
Responsiveness of 61.82%
Hospital Staff.
Pain Management........ 68.75%
Communication About 59.28%
Medicines.
Cleanliness and 62.80%
Quietness of Hospital
Environment.
Discharge Information.. 81.93%
Overall Rating of 66.02%
Hospital.
------------------------------------------------------------------------
We are also finalizing the achievement thresholds for the three
mortality measures, (displayed as survival rates) in Table 5 below
based on a 12-month baseline period from July 1, 2009 to June 30, 2010:
[[Page 26513]]
Table 5--Achievement Thresholds for the FY 2014 Hospital VBP program
Mortality Outcome Measures (Displayed as Survival Rates)
------------------------------------------------------------------------
Performance
standard
Measure ID Measure description (achievement
threshold)
------------------------------------------------------------------------
Mortality Outcome Measures
------------------------------------------------------------------------
MORT-30-AMI.................... Acute Myocardial 84.8082%
Infarction (AMI) 30-
Day Mortality Rate.
MORT-30-HF..................... Heart Failure (HF) 30- 88.6109%
Day Mortality Rate.
MORT-30 PN..................... Pneumonia (PN) 30-Day 88.1795%
Mortality Rate.
------------------------------------------------------------------------
F. Methodology for Calculating the Total Performance Score
1. Statutory Provisions
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 5 requirements related
to the scoring methodology developed by the 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 Total
Performance Scores receiving the largest value-based incentive
payments.
Section 1886(o)(5)(B)(ii) provides that, under the methodology, the
hospital Total Performance Score must be determined using the higher of
the applicable hospital's 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
As discussed in the Hospital Inpatient VBP Program proposed rule,
in addition to statutory requirements, we also considered several
additional factors when developing the proposed performance scoring
methodology for the Hospital VBP program. First, we stated our belief
that it is important that the performance scoring methodology is
straightforward 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 stated our belief that the scoring methodologies for all
Medicare Value-Based Purchasing programs, including (but not limited
to) the End Stage Renal Disease Quality Incentive Program 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 stated our belief
that differences in performance scores must reflect true differences in
performance. In order to ensure this in the proposed Hospital VBP
Program, we assessed the quantitative characteristics of the measures
we are proposing to use to calculate the Total 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
stated that we must appropriately measure both quality achievement and
improvement in the Hospital VBP program. Section 1886(o)(5)(B)(ii) of
the Act specifies that performance scores under the Hospital VBP
program be calculated utilizing the higher of achievement and
improvement scores for each measure; 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 stated that we wished to eliminate unintended
consequences for rewarding inappropriate hospital behavior and outcomes
to patients in our performance scoring methodology. Sixth, we stated
that we wished 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.
The methodology proposed in the Hospital Inpatient VBP Program
proposed rule for calculating the improvement score relies on a
comparison of the hospital's performance during the performance period
against its performance during a baseline period rather than a
comparison of the hospital's performance during a particular year
against its performance during a previous year (as was outlined in the
2007 Report to Congress).
We stated that we planned 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.
In the Hospital Inpatient VBP Program proposed rule, we solicited
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 welcomed suggestions on improving the simplicity of the Hospital
VBP program performance score methodology and its alignment with other
CMS quality initiatives.
[[Page 26514]]
3. Background
In November 2007, CMS published 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.
---------------------------------------------------------------------------
\6\ The report may be found at http://www.cms.gov/AcuteInpatientPPS/downloads/HospitalVBPPlanRTCFINALSUBMITTED2007.pdf.
---------------------------------------------------------------------------
The Performance Assessment Model provides a methodology for
evaluating a hospital's performance on each 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 the Hospital VBP
program by awarding points for showing improvement on 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
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 the
Hospital VBP incentive payment earned using an exchange function, which
aligns payments with desired policy goals.
4. FY 2013 Hospital VBP Program Scoring Methodology
As stated in the Hospital Inpatient VBP Program proposed rule, we
believe that the Performance Assessment Model presented and analyzed in
the 2007 Report to Congress provides a useful foundation for developing
the 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 discussed in this Final
Rule).
After carefully reviewing and evaluating a number of potential
performance scoring methodologies for the Hospital VBP program, we
proposed to use a Three-Domain Performance Scoring Model, although we
proposed that only two domains would receive weight in FY 2013. This
methodology is very similar to the Performance Assessment Model;
however, it incorporates an outcome measure domain in addition to the
clinical process of care and patient experience of care domains.
While we did not propose to adopt any outcome measures for the FY
2013 Hospital VBP program, we proposed to adopt these measures as part
of an outcome measures domain for FY 2014. The proposed Three-Domain
Performance Scoring Model includes setting benchmarks and thresholds,
scoring hospitals on achievement and improvement for three domains
(clinical process of care, patient experience of care, and outcomes),
weighting the domains, and calculating the hospital Total Performance
Score.
a. Setting Performance Benchmarks and Thresholds
As stated above, section 1886(o)(5)(B)(ii) of the Act requires that
under the Hospital VBP program 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.
In the Hospital Inpatient VBP Program proposed rule, we proposed
that hospitals will 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 proposed
that hospitals will 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 proposed to establish the benchmarks and
achievement thresholds for the FY 2013 Hospital VBP program using
national data from a three-quarter baseline period of July 1, 2009
through March 31, 2010.
To define a high level of hospital performance on a given measure,
we proposed to set the benchmark at the mean of the top decile of
hospital scores on the clinical process of care, and outcome measures
during the baseline period. For the patient experience of care
measures, we proposed to set the benchmark at the 95th percentile of
hospital performance during the baseline period. We stated that this
would ensure that the benchmark represents demonstrably high but
achievable standards of excellence; in other words, the benchmark will
reflect observed scores for the highest-performing hospitals on a given
measure.
We proposed 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 achievement threshold to
earn achievement points.
Comment: We received many comments stating that the proposed
benchmarks were too high. Some commenters stated that this was
evidenced by the fact that for many of the proposed measures,
performance at the benchmark would require hospitals to achieve 100
percent success on the measure. In addition to stating that this level
of performance could be too difficult for some hospitals to achieve,
some commented that this would serve as an inappropriate benchmark in
light of the fact that the measures do not incorporate all clinically
relevant exclusion criteria based on every patient's particular
situation. One commenter supported setting the benchmark at the 80th
percentile in the
[[Page 26515]]
baseline period for the patient experience of care domain to ensure
that every hospital has a chance of exceeding the benchmark.
Response: As we stated in the Hospital Inpatient VBP program
proposed rule, the benchmark is intended to represent an empirically-
demonstrated level of excellent performance during the baseline period
(76 FR 2471), and we believe that this standard represents achievable
excellence for all hospitals during the performance period. We
recognize that some of the proposed clinical process of care measures
do not meet our criteria for topped-out status but still have a
benchmark of 100 percent success.
We consider a benchmark to be an empirically-observed level of
excellent performance to which we believe hospitals generally should
aspire. Using the proposed definition of a benchmark (mean value for
the top 10 percent of hospitals during the baseline period), typically
only about 5 percent of all hospitals will be observed to have achieved
the benchmark level for an individual measure during the baseline
period. However, any number of hospitals could score at or above the
benchmark during the performance period, and under the proposed
performance scoring methodology, such hospitals would receive the full
10 points on the measure. A benchmark level of 100 percent is a special
case in which at least 10 percent of hospitals achieved a 100 percent
success rate on the measure during the baseline period. When a
benchmark for a measure is 100 percent, at least half of all reporting
hospitals will receive at least some achievement points on the measure
(assuming no general degradation of performance among hospitals), which
is the same as every other measure. Arbitrarily setting benchmark
levels (for example, at 80th percentile) would undermine its
empirically-based definition, as would, for example, arbitrarily
setting the benchmark at 100 percent for every measure.
As stated above, when a benchmark is 100 percent, at least 10
percent of hospitals would have to have achieved 100 percent on the
measure during the baseline period; this suggests that achieving 100
percent success on a measure is not prohibitively difficult as a
portion of hospitals will have actually achieved that standard. In rare
instances, a hospital might not provide a process covered by a clinical
process of care measure because none of those measures currently allow
for blanket discretionary exclusions that would enable a hospital to
exclude a case based on any conceivable set of circumstances. As a
result, a measure calculation might capture a rare case that arguably
could have been excluded, such as a case where the patient was allergic
to all indicated drugs, or the patient refused services and/or asked to
be discharged against medical advice. As new information becomes
available concerning possible unintended consequences of measures,
their specifications can be reviewed and revised as necessary,
including the addition of supplemental exclusion criteria. This process
is ongoing and, we believe, is a better way to deal with rare cases
instead of setting a benchmark at an indiscriminate, low value such as
the 80th percentile.
All measures have limitations and it is therefore possible that a
hospital, in the unfortunate but rare instance in which it provides
what it believes is the best quality of care, will fail to achieve the
benchmark. It is partly for this reason that we proposed to set the
achievement performance standard for each measure at the achievement
threshold rather than the benchmark. We also emphasize that a
hospital's value-based incentive payment is based on its Total
Performance Score, not on performance at the benchmark for every
measure. Our analysis indicates that small differences in points on a
single measure caused by missing the benchmark have little impact on
the distribution of incentive payments and rank correlation of
hospitals.
Comment: One commenter argued that high-performing hospitals ``who
already beat national benchmarks'' have incentives to perform poorly
``in the short term'' so that they can then win improvement points and
receive higher payments.
Response: We assume that the commenter is suggesting a scenario in
which a high-performing hospital might attempt to intentionally score
lower on one or more measures during the baseline period in order to
score improvement points during the performance period. First, we
expect all Medicare hospitals to provide high-quality care to their
patients regardless of whether they are included in the Hospital VBP
program or not. Furthermore, we disagree that high-achieving hospitals
would have an incentive to lower their performance in order to win
improvement points in the Hospital VBP program. We note that under the
proposed Three-Domain Scoring Methodology, the maximum number of
achievement points possible on a given measure is higher (10 points)
for achieving the benchmark, than the maximum number of improvement
points possible (9 points). It is difficult to envision a scenario in
which a high-performing hospital would earn more overall points on a
measure (that is, the higher of achievement and improvement points) by
intentionally lowering its performance during the baseline period and
increasing performance during the performance period versus simply
maintaining high performance during the baseline period and seeking to
maintain or improve on that performance during the performance period.
However, we plan to closely monitor and evaluate the impact of the
Hospital VBP program on the quality of care provided to Medicare
beneficiaries.
After consideration of the public comments, we are finalizing as
proposed the definition of the benchmark as the mean of the top decile
of hospital performance during the baseline period for the clinical
process of care and outcome measures. In response to numerous public
comments (further discussed below) requesting greater uniformity
between the scoring of clinical process of care measures, outcome
measures, and HCAHPS dimensions, we are also finalizing the definition
of the benchmark as the mean of the top decile of performance during
the baseline period for the patient experience of care domain.
The finalized benchmarks for the clinical process of care and
patient experience of care domains for the FY 2013 Hospital VBP Program
are provided below in Table 6. The finalized benchmarks for the three
30-day mortality outcome measures for the FY 2014 Hospital VBP Program
are provided below in Table 7.
Table 6--Benchmarks That Apply to the FY 2013 Hospital VBP Program
Measures
------------------------------------------------------------------------
Measure ID Measure description Benchmark
------------------------------------------------------------------------
Clinical Process of Care Measures
------------------------------------------------------------------------
AMI-7a......................... Fibrinolytic Therapy 0.9191
Received Within 30
Minutes of Hospital
Arrival.
AMI-8a......................... Primary PCI Received 1.0
Within 90 Minutes of
Hospital Arrival.
[[Page 26516]]
HF-1........................... Discharge Instructions. 1.0
PN-3b.......................... Blood Cultures 1.0
Performed in the
Emergency Department
Prior to Initial
Antibiotic Received in
Hospital.
PN-6........................... Initial Antibiotic 0.9958
Selection for CAP in
Immunocompetent
Patient.
SCIP-Inf-1..................... Prophylactic Antibiotic 0.9998
Received Within One
Hour Prior to Surgical
Incision.
SCIP-Inf-2..................... Prophylactic Antibiotic 1.0
Selection for Surgical
Patients.
SCIP-Inf-3..................... Prophylactic 0.9968
Antibiotics
Discontinued Within 24
Hours After Surgery
End Time.
SCIP-Inf-4..................... Cardiac Surgery 0.9963
Patients with
Controlled 6AM
Postoperative Serum
Glucose.
SCIP-VTE-1..................... Surgery Patients with 1.0
Recommended Venous
Thromboembolism
Prophylaxis Ordered.
SCIP-VTE-2..................... Surgery Patients Who 0.9985
Received Appropriate
Venous Thromboembolism
Prophylaxis Within 24
Hours Prior to Surgery
to 24 Hours After
Surgery.
SCIP-Card-2.................... Surgery Patients on a 1.0
Beta Blocker Prior to
Arrival That Received
a Beta Blocker During
the Perioperative
Period.
------------------------------------------------------------------------
HCAHPS......................... Communication With 84.70%
Nurses.
Communication With 88.95%
Doctors.
Responsiveness of 77.69%
Hospital Staff.
Pain Management........ 77.90%
Communication About 70.42%
Medicines.
Cleanliness and 77.64%
Quietness of Hospital
Environment.
Discharge Information.. 89.09%
Overall Rating of 82.52%
Hospital.
------------------------------------------------------------------------
Table 7--Final Benchmarks for the FY 2014 Hospital VBP Program Mortality
Outcome Measures (Displayed as Survival Rates)
------------------------------------------------------------------------
Measure ID Measure description Benchmark
------------------------------------------------------------------------
Mortality Outcome Measures
------------------------------------------------------------------------
MORT-30-AMI.................... Acute Myocardial 86.9098%
Infarction (AMI) 30-
Day Mortality Rate.
MORT-30-HF..................... Heart Failure (HF) 30- 90.4861%
Day Mortality Rate.
MORT-30 PN..................... Pneumonia (PN) 30-Day 90.2563%
Mortality Rate.
------------------------------------------------------------------------
b. Calculating Achievement, Improvement Points, and Consistency Points
We proposed a scoring methodology that would assign an achievement
and improvement score to each hospital for each of the clinical process
of care and outcome measures that apply to the hospital, and for each
HCAHPS dimension. We proposed that a hospital will earn 0-10 points for
achievement based on where its performance for the measure fell
relative to the achievement threshold and the benchmark.
We proposed 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 scoring methodology we proposed to implement for HCAHPS
includes achievement, improvement, and consistency points. We proposed
that for the FY 2013 Hospital VBP program hospitals may earn from 0-20
consistency points based on the lowest of its 8 HCAHPS dimension
scores.
We refer readers to the Hospital Inpatient VBP Program proposed
rule (76 FR 2470-2487) for the details of the proposed scoring
methodologies and examples of how hospital total performance scores are
calculated under the Three-Domain Performance Scoring Model.
Our responses to public comments are provided below.
Comment: One commenter asked us to outline the scoring model for
outcome measures before proposing their use.
Response: As detailed in the Hospital Inpatient VBP Program
proposed rule (76 FR 2466), we proposed that the outcome domain would
be scored using the same methodology that we proposed to use to score
the clinical process of care domain. That methodology is finalized in
this final rule.
Comment: We received numerous comments asking CMS to more closely
align the scoring methodologies and formulas used to calculate points
in the clinical process of care and patient experience of care domains.
Commenters specifically suggested that we use percentages rather than
percentiles in the HCAHPS scoring methodology and questioned why we
chose different methodologies to calculate the benchmarks in the
clinical process of care and patient experience of care domains. These
commenters suggested that the patient experience of care scoring model
laid out in the proposed rule was too complex and differed too greatly
from the clinical process of care scoring model. Commenters also
suggested that CMS create greater uniformity in Hospital VBP scoring
formulas across the domains, including the formulation of the
benchmarks.
Response: In the initial analyses of HCAHPS data for the 2007
Report to Congress, which was based on about 500 hospitals and three
quarters of HCAHPS results, we found that a few small hospitals
achieved much higher HCAHPS scores than most. Thus, a non-percentile
approach for HCAHPS would have led to a skewed distribution of
achievement points (most clustered at the low end and few high scores).
At the time of the 2007 Report to Congress, the percentile approach did
a better job of spreading out the achievement points.
[[Page 26517]]
When we re-examined this issue in response to comments to the
Hospital Inpatient VBP Program proposed rule, we found that our current
data, which is based upon over 3,000 hospitals with several years of
experience using HCAHPS, show that the distribution of scores has
changed over time and that there is no longer a skewed distribution of
achievement points using a non-percentile approach.
Therefore, we will abandon the use of percentiles for calculating
the benchmark in HCAHPS in Hospital VBP and instead will finalize the
use of percentages of top-box scores in our HCAHPS calculations. As
stated below, we believe that this change will both simplify the
calculation of HCAHPS scores and will make HCAHPS scoring more
comparable to that of the clinical process of care and outcome measures
in the Hospital VBP program.
In response to numerous comments received, we are finalizing the
definition of the benchmark for each measure in the patient experience
of care domain as the mean of the top decile of hospital performance on
the measure (for purposes of the HCAHPS measure, this would be each
HCAHPS dimension) during the baseline period. We believe this policy
results in more uniform scoring methodologies across domains and
appropriately reflects our decision to abandon the use of percentiles
in the patient experience of care domain. We have made technical
changes to the formulas used to calculate achievement and improvement
points reflecting these finalized policies below.
As shown in Table 8, for each of the 8 HCAHPS dimensions we are
finalizing for the FY 2013 Hospital VBP program, scores will be based
on the publicly-reported proportions of best category (``top-box'')
responses. (As noted above, top-box responses, as publicly reported on
the Hospital Compare Web site, are the most positive responses to
HCAHPS survey questions and are adjusted for patient-mix and survey
mode). Please note that the ``Cleanliness and Quietness'' dimension is
the average of the publicly reported stand-alone ``Cleanliness'' and
``Quietness'' ratings.
Table 8--Eight HCAHPS Dimensions for the FY 2013 Hospital VBP Program
----------------------------------------------------------------------------------------------------------------
Dimension (composite or stand-alone item) Constituent HCAHPS survey items
----------------------------------------------------------------------------------------------------------------
1. Communication with Nurses (% ``Always'')..... Nurse--Courtesy/Respect.
Nurse--Listen.
Nurse--Explain.
2. Communication with Doctors (% ``Always'').... Doctor--Courtesy/Respect.
Doctor--Listen.
Doctor--Explain.
3. Responsiveness of hospital staff (% Bathroom Help.
``Always''). Call Button.
4. Pain management (% ``Always'')............... Pain Control.
Help with Pain.
5. Communication about Medicines (% ``Always''). New Medicine--Reason.
New Medicine--Side Effects.
6. Hospital Cleanliness & Quietness (% Cleanliness and Quietness.
``Always''). Discharge--Help.
I. Discharge Information (% ``Yes'')........
7. Overall rating (% ``9 or 10'')............... Discharge--Systems.
8. Overall Rating of Hospital (% ``9 or 10'')... Overall Rating.
----------------------------------------------------------------------------------------------------------------
Comment: Some commenters recommended that HCAHPS be excluded from
the Hospital VBP program until an examination and public vetting of the
scoring methodology takes place.
Response: The scoring methodology proposed for HCAHPS was part of
the original Report to Congress in 2007 and was subject to stakeholder
input through multiple listening sessions. The final methodology
described in this final rule is more similar to the clinical process of
care scoring methodology since it now uses percentages not percentiles.
The notice and comment rulemaking process for this rule has allowed the
public to vet CMS' proposals. In response to public comments, CMS is
making an additional change to the HCAHPS scoring methodology (this
change is discussed below).
Comment: Many commenters opposed our proposal to use consistency
points in the patient experience of care domain. Others suggested that
we consider using consistency points in the clinical process of care
domain.
Response: For reasons detailed in the 2007 Report to Congress and
the Hospital Inpatient VBP Program proposed rule (76 FR 2472), we
believe that consistency points recognize and reward consistent
achievement across HCAHPS dimensions. By offering hospitals additional
incentives to achieve across all HCAHPS dimensions, consistency points
promote wider systems changes within hospitals to improve quality. We
will consider developing consistency points for the clinical process of
care domain in the future. However, we note that applying consistency
points in that domain would be methodologically challenging. All
hospitals must report all dimensions of the HCAHPS survey, and for that
reason, all hospitals will earn scores on all dimensions on which we
can use to fairly reward consistency. Applying consistency points to
the clinical process of care domain when different numbers of measures
might apply to different hospitals may result in unfair distributions
of consistency points. We welcome input on an appropriate methodology
for clinical process of care consistency points.
Comment: A number of commenters suggested technical changes to the
formulas proposed to be used to calculate achievement and improvement
points. In suggesting these technical changes, commenters pointed out
that under the proposed formulas for clinical process of care and
outcome measure scoring, a hospital with a score equal to the
achievement threshold would receive a score of .5, which rounds to 1,
while a hospital with a score equal to the benchmark would receive a
score of 9.5, which rounds to 10. Commenters pointed out that this
formula effectively creates a scale of 0.5 to 9.5 instead of a scale
from 1 to 10. These commenters urged CMS to modify the formula so that
the scale ``starts'' at 1 instead of 0.5, and urged CMS to make similar
modifications for the formula used to calculate improvement points for
the
[[Page 26518]]
clinical process of care and outcome measures.
Response: The formula for achievement points reflects the
description of how points are assigned to hospitals with scores between
the threshold and benchmark values. For such hospitals, the range
between the achievement threshold and benchmark values is partitioned
into 9 equally spaced intervals and a hospital is awarded from 1 to 9
points, depending on which of the nine equally spaced intervals its
score falls. The offered alternatives satisfy much of this description,
but fail to meet the equal-spacing property. In particular, if we
revised the scale along the lines suggested by the commenters, the
interval of scores needed to receive one point would be only half as
large as the remaining eight intervals. As a result, the number of
hospitals receiving one point would be reduced and our ability to
distinguish among hospitals on the lower end of the scale would also be
reduced.
Regarding the specific comment that the scoring scale starts with
only 0.5, we note that, in fact, hospitals scoring within the
achievement range start with a score of ``round (.5).'' The ``round''
function is part of the formula and cannot be ignored without
significantly altering the resulting calculations, which would prevent
us from implementing equal spacing within the achievement and
improvement ranges as described above. We note that within the formula,
any value that ends in .5 rounds to the next higher integer, so
``round(.5)'' equals 1 and a hospital scoring at the achievement
threshold receives 1 point on that measure. Likewise, a score of 4.5
rounds to 5, and so on.
The formula for improvement points is similar except that it
divides the range between the hospital's baseline score and the
benchmark into 9 equally-spaced intervals and awards a hospital a score
between 0 and 9 improvement points. Again, the round function is part
of the formula and needs to be acknowledged (with the similar
stipulation that values ending in .5 round to the next higher integer).
Thus, a hospital with a score exactly equal to its improvement
threshold receives a score of round (-.5), which would equal 0 points.
Comment: One commenter recommended that the point conversions and
reconversion steps be removed from the mathematical calculations, and
that CMS develop a more direct calculation method rather than scoring
hospitals with points based on measure rates and later converting point
totals into domain scores.
Response: The point calculations used to score hospitals on
performance measures reflect our intent to provide a more[?] robust
measure scoring methodology than[?] is possible with a more direct
score calculation. We believe that the point conversions from raw
measure scores to the 0-10 and 0-9 achievement and improvement ranges,
respectively, enable us to more clearly communicate assessments of
hospital performance to hospitals and the public. We note that the
point calculations allow us to easily calculate and combine points
earned for both achievement and improvement, as well as compare
hospitals earning points on different measures in cases when the
relevant achievement ranges may differ substantially. We will evaluate
the impact of the scoring methodology and will continue to examine
alternative scoring methodologies for future years of the program.
Comment: Some commenters suggested that the proposed scoring
methodology undervalues improvement, and that establishing a lower
``improvement benchmark'' would be more appropriate so that the
improvement range is the same for every hospital.
Response: We believe establishing a lower benchmark would
undervalue achievement by lowering the standard by which hospitals may
achieve 10 points as well as the importance of improving to the highest
level of care. Setting a separate, lower benchmark for the improvement
range might also encourage higher achieving hospitals to underperform,
as they would be rewarded more highly for achieving a lower level of
improvement. A higher benchmark also allows every hospital to improve
as much as possible and to the highest level of care.
Comment: Some commenters agreed with our proposal to exclude the
``Would You Recommend'' item in the HCAHPS performance score and to
include only the Overall Rating because they believe that ``recommend''
is properly characterized as a measure of expectations. Other
commenters thought both the Overall Rating and ``Would You Recommend''
should be included. One commenter thought the Overall Rating should
receive more weight than the other HCAHPS dimensions because the
commenter viewed it as an outcome measure.
Response: We decided to include only the Overall Rating and not the
``Would You Recommend'' item in the HCAHPS measure because the two
global ratings are highly correlated and the ``Would You Recommend''
item is more likely to measure expectations and other factors rather
than the actual patient experience. It is important to note that, while
there is a high correlation between these items overall, there can
still be divergence for some hospitals. Thus for purposes of the
Hospital IQR program, these two dimensions will be reported separately.
With regard to giving greater weight to the Overall Rating item, we
believe that the Overall Rating item is no more of an outcome than the
other HCAHPS items, so it has been given the same weight as the other
HCAHPS dimensions in the Hospital VBP scoring formula. Compared to the
other HCAHPS dimensions, the Overall Rating focuses on the overall
experience, while the other dimensions focus on specific aspects of the
hospital stay.
As discussed above, we are finalizing an HCAHPS scoring approach
that does not use percentiles, and instead will adopt an approach that
uses the percentage of top-box scores for scoring a hospital's HCAHPS
calculations. We believe that this change will both simplify the
calculation of HCAHPS scores and will make the HCAHPS scoring more
comparable to that of the clinical process of care and outcome
measures.
Accordingly, after considering public comments, we are finalizing
the scoring methodology as follows:
Hospitals will receive an achievement and improvement score for
each of the clinical process of care and outcome measures that apply to
them, and for each HCAHPS dimension. Hospital will earn between 0-10
points for achievement based on where its performance for the measure
falls relative to the achievement threshold and the benchmark according
to the following formula:
[9 * ((Hospital's performance period score - achievement threshold)/
(benchmark - achievement threshold))] + .5, where the hospital
performance period score falls in the range from the achievement
threshold to the benchmark
All achievement points will 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 is:
Equal to or greater than the benchmark, the hospital will
receive 10 points for achievement.
Equal to or greater than the achievement threshold (but
below the benchmark), the hospital will receive a score of 1-9 based on
a linear scale established for the achievement range
[[Page 26519]]
(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 will receive 0 points for
achievement.
Hospitals will earn between 0-9 points based on how much their
performance on the measure during the performance period improves from
their performance on the measure during the baseline period 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 will be rounded to the nearest whole number.
If a hospital's score on the measure during the performance period
is:
Greater than its baseline period score but below the
benchmark (within the improvement range), the hospital will 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 will receive 0 points for improvement.
Hospitals will earn between 0-20 consistency points on the HCAHPS
measure based on the lowest of its 8 HCAHPS dimension scores.
A hospital will receive 0 consistency points if its performance on
one or more HCAHPS dimensions during the performance period is at least
as poor as the worst-performing hospital's performance on that
dimension during the baseline period. A hospital will receive a maximum
score of 20 consistency points if its performance on all 8 HCAHPS
dimensions is at or above the achievement threshold.
Based on comments discussed above, consistency points will be
awarded proportionately based on the single lowest of a hospital's 8
HCAHPS dimension scores during the performance period compared to the
achievement threshold (the 50th percentile of the baseline performance
score) for that specific HCAHPS dimension. If the lowest score is less
than the achievement threshold, then the score is based on the distance
between the achievement threshold (50th percentile of baseline) and the
floor (0th percentile of baseline). If all 8 of a hospital's dimension
scores during the performance period are at or above the achievement
threshold (50th percentile of hospital performance in the baseline
period), then that hospital will earn all 20 consistency points. (That
is, if the lowest of a hospital's eight HCAHPS dimension scores is at
or above the 50th percentile of hospital performance on that dimension
during the baseline period, then that hospital will earn the maximum of
20 consistency points). If the lowest score a hospital receives on an
HCAHPS dimension is at or below the floor of hospital performance on
that dimension during the baseline period, then 0 consistency points
will be awarded to that hospital. Otherwise, consistency points will be
awarded proportionately according to the distance of the performance
period score for that dimension between the floor and the achievement
threshold.
We define the lowest dimension score as the lowest value across the
eight HCAHPS dimensions using the following formula:
((Hospital's performance period score--floor)/(achievement threshold--
floor)).
The formula for the HCAHPS consistency points score is as follows:
(20 * (lowest dimension score)-0.5), rounded to the nearest whole
number, with a minimum of zero and a maximum of 20 consistency points.
Consistency points will be rounded to the nearest whole number (for
example, 9.5 consistency points would be rounded to 10 points).
Table 9 below displays floors, achievement thresholds, and
benchmarks for HCAHPS consistency points applicable to FY 2013 using a
baseline period of July 1, 2009-March 31, 2010.
Table 9--HCAHPS \1\ Top-Box Scores \2\ Representing the Floor (Minimum), Achievement Threshold (50th Percentile)
and Benchmark (Mean of Top Decile) for Hospital Value-Based Purchasing: Baseline Period (July 1, 2009-March 31,
2010)
----------------------------------------------------------------------------------------------------------------
Achievement
Floor threshold Benchmark
HCAHPS dimension (minimum) (50th (mean of top
percentile) decile)
----------------------------------------------------------------------------------------------------------------
Communication with Nurses....................................... 38.98 75.18 84.70
Communication with Doctors...................................... 51.51 79.42 88.95
Responsiveness of Hospital Staff................................ 30.25 61.82 77.69
Pain Management................................................. 34.76 68.75 77.90
Communication about Medicines................................... 29.27 59.28 70.42
Hospital Cleanliness & Quietness................................ 36.88 62.80 77.64
Discharge Information........................................... 50.47 81.93 89.09
Overall Rating of Hospital...................................... 29.32 66.02 82.52
----------------------------------------------------------------------------------------------------------------
\1\ Includes IPPS hospitals with 100+ completed surveys from patients discharged between July 2009 and March
2010 (3,211 hospitals). Scores have been adjusted for survey mode and patient-mix.
\2\ ``Top-box'' score is the percentage of patients who chose the most positive response to HCAHPS survey items.
As stated above, we also note that, to achieve greater uniformity
of scoring for all of the domains, we are finalizing the definition of
the benchmark as the mean of the top decile of performance on the
HCAHPS dimensions, rather than the 95th percentile of performance as we
had proposed.
We have provided three examples describing how the clinical process
of care and outcome measures will be scored. These examples are similar
to those that were provided in the Hospital Inpatient VBP proposed rule
(76 FR 2467-2470), but illustrate scoring on a different measure since
PN-2, used in the proposed rule, is now topped-out. Three more examples
illustrate how the
[[Page 26520]]
finalized scoring methodology will be applied to the HCAHPS dimensions.
The clinical process of care examples use AMI-7a ``Fibrinolytic Therapy
Received Within 30 Minutes of Hospital Arrival,'' while the HCAHPS
examples are based on the ``Doctor Communication'' dimension.
Figure 1 shows measure scoring for Hospital B. The benchmark
calculated for AMI-7a in this case was 0.9191 (the mean value of the
top decile during the baseline period), and the achievement threshold
was 0.6548 (the performance of the median or the 50th percentile
hospital during the baseline period). Hospital B's performance rate of
0.93 during the performance period for this measure exceeds the
benchmark, so Hospital B would earn 10 points (the maximum) for
achievement. The hospital's performance rate on a measure is expressed
as a decimal. In the illustration, Hospital B's performance rate of
0.93 means that 93 percent of applicable patients received Fibrinolytic
Therapy within 30 minutes of arrival. (Because Hospital B has earned
the maximum number of points possible for this measure, its improvement
score would be irrelevant.)
[GRAPHIC] [TIFF OMITTED] TR06MY11.045
Figure 2 shows the scoring for another hospital, Hospital I. As can be
seen below, the hospital's performance on this measure went from 0.4297
(below the achievement threshold) in the baseline period to 0.8163
(above the achievement threshold) in the performance period. Applying
the achievement formula, Hospital I would earn 6 points for this
measure, calculated as follows:
[9 * ((0.8163-0.6548)/(0.9191-0.6548))] + 0.5 = 5.5 + 0.5 = 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 formula, based on Hospital I's period-to-period
improvement, from 0.4297 to 0.8163, Hospital I would earn 7 points,
calculated as follows:
[10 * ((0.8163-0.4297)/(0.9191-0.4297))]-0.5 = 7.9-0.5 = 7.4, 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).
[[Page 26521]]
[GRAPHIC] [TIFF OMITTED] TR06MY11.046
In Figure 3 shown below, Hospital L's performance on AMI-7a drops
from 0.72 to 0.64 (a decline of 0.08 points). Because this hospital's
performance during the performance period is lower than the achievement
threshold of 0.6548, it receives 0 points based on achievement. It
would also receive 0 points for improvement, because its performance
during the performance period is lower than its performance during the
baseline period. In this example, Hospital L would receive 0 points for
the measure.
[[Page 26522]]
[GRAPHIC] [TIFF OMITTED] TR06MY11.047
Figure 4 shows Hospital B's scoring on the doctor communication
dimension. It scores a 90 percent, 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.
[[Page 26523]]
[GRAPHIC] [TIFF OMITTED] TR06MY11.048
Figure 5 shows that Hospital I's performance on the doctor
communication dimension rose from 77.19 percent during the baseline
period to 82.07 percent during the performance period. Because Hospital
I's performance during the performance period exceeds the achievement
threshold of 79.42 percent, Hospital I's score would fall within the
achievement range. According to the achievement scale, Hospital I would
earn 3 achievement points, calculated as follows:
[9 * ((82.07-79.42)/(88.95-79.42))] + 0.5 = 2.5 + 0.5 = 3
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 achievement. Applying the improvement scale, Hospital I's
period-to-period improvement from 77.19 percent to 82.07 percent would
earn 3.65 improvement points, which would be rounded to 4 points
calculated as follows:
[10 * ((82.07-77.19)/(88.95-77.19))]-0.5 = 3.65
Using the greater of the two scores, Hospital I would receive 4 points
for this dimension (rounded to the nearest whole number).
[[Page 26524]]
[GRAPHIC] [TIFF OMITTED] TR06MY11.049
In Figure 6, Hospital L's performance in the baseline period was at
11 percent, and its performance declined in the performance period to 6
percent. Because Hospital L's performance during the performance period
is lower than the achievement threshold of 79.42 percent, it would
receive 0 points based on achievement. Hospital L would also receive 0
points for improvement because its performance during the performance
period is lower than its performance during the baseline period.
[[Page 26525]]
[GRAPHIC] [TIFF OMITTED] TR06MY11.050
c. The Total Domain Score and the Total Performance Score
We proposed to group the measures for the Hospital VBP program into
domains, which we proposed to define as categories of measures by
measure type. Because the clinical process of care and outcome measure
performance scores will be based only on the measures that apply to the
hospital, we proposed to normalize the domain scores across hospitals
by converting the points earned for each domain to a percentage of
total points. We proposed 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.
For purposes of the Hospital VBP program in FY 2013, we also
proposed that only two domains will be scored, the clinical process of
care and patient experience of care. In determining how to
appropriately weight quality measure domains, we considered a number of
criteria. Specifically, we considered the number of measures that we
proposed to include in each domain and the reliability of individual
measure data. We also considered the systematic effects of alternative
weighting schemes on hospitals according to their location and
characteristics (for example, by region, size, and teaching status) and
Departmental quality improvement priorities. We strongly believe that
outcome measures are important in assessing the overall quality of care
provided by hospitals. However, for reasons outlined in the Hospital
Inpatient VBP Program proposed rule (76 FR 2461), we did not propose to
include outcome measures in the FY 2013 Hospital VBP program. Taking
all of these considerations into account, we proposed 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
proposed this weighting scheme because the proposed clinical process of
care measures comprise all but one of the measures we proposed to
include in the FY 2013 Hospital VBP program. We believe assigning a 30
percent weight to the patient experience of care domain is appropriate
because the HCAHPS measure is comprised of eight dimensions that
address different aspects of patient satisfaction.
We solicited public comment on the domain weighting approach and
calculation of the total performance score, as well as the utility and
appropriateness of alternative methods.
Comment: Some commenters suggested that we weight Total Performance
scores by ``opportunities to provide care,'' rather than equally
weighting each measure within each domain.
Response: We thank commenters for their suggestion. However, we
believe that weighting each measure within a domain equally will
encourage hospitals to consider each of them equally in their quality
improvement initiatives. We also believe that weighting by the number
of opportunities, the suggested alternative, would overemphasize the
SCIP measures, which often have opportunity counts that are much larger
than the corresponding counts for measures related to other topics or
conditions.
Comment: Many commenters opposed our proposal to weight the patient
experience of care domain at 30 percent, arguing that the HCAHPS survey
composing the domain is subjective, and is not sufficiently risk
adjusted for
[[Page 26526]]
patient characteristics or other factors. Those commenters suggested
various proposed weights but generally called on us to lower the
patient experience of care domain weight. One commenter suggested that
we weight the patient experience of care domain higher than 30 percent
of the Total Performance Score. A few commenters supported our
proposal.
Response: We appreciate the commenters' suggestions. However, we
disagree with weighting the patient experience of care domain either
higher or lower than proposed. As we detailed in the Hospital Inpatient
VBP Program proposed rule (76 FR 2475), we considered many factors when
determining the appropriate domain weights for the FY 2013 program,
including the number of measures in each domain, the reliability of
individual measure data, systematic effects of alternative weighting
schemes on hospitals according to their location and characteristics,
and Departmental quality improvement priorities. We also believe that
delivery of high-quality, patient-centered care requires us to
carefully consider the patient's experience in the hospital inpatient
setting.
Comment: Some commenters suggested that CMS should convene focus
groups of Medicare beneficiaries to determine the relative importance
of clinical process of care and patient experience of care domains for
weighting.
Response: We believe that we have received significant public input
to inform our approach for weighing each domain. Many public comments
on the proposed rule discussed the weighing and relative importance of
the domains, and supported the proposed weighting distribution. We
will, however, continue to monitor the weighing distribution between
domains and will consider commenters' suggestions as the program goes
forward and new measures and domains are added.
Comment: Commenters suggested that we place greater weight on
outcome measures compared to clinical process of care measures and that
we emphasize overall rating dimensions of the HCAHPS survey over other
dimensions.
Response: We will take the commenters' suggestion to weight the
outcome domain more heavily than the clinical process of care domain as
we develop our weighting proposals for the FY2014 Hospital VBP program.
However, as we stated earlier, we believe that all measures within a
domain should be weighted equally in order to encourage hospitals to
improve their performance on all of them.
Based on the comments we received, we are finalizing the
calculation of the clinical process of care and outcome domain scores
as follows:
1. For each domain:
Total earned points for domain = Sum of points earned for all
applicable domain measures
2. Each hospital also has 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
3. For each domain, the total domain score would be calculated as a
percentage, as follows:
Domain score = Total earned points for domain divided by Total possible
points for domain multiplied by 100 percent.
We are also finalizing the calculation of the patient experience of
care domain 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 8 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.
After consideration of public comments, we are finalizing the
calculation of a hospital's Total Performance Score as follows:
Multiply the hospital's performance score for each domain by the weight
for that domain (70 percent clinical process of care, 30 percent
patient experience of care), and add those weighted scores together.
d. Alternative Performance Scoring Models
We discussed our analysis of several alternative performance
scoring models in addition to the model proposed (76 FR 2476-2478). We
solicited public comments on the proposed model as well as the other
potential performance scoring models. The comments we received on these
models and our responses are set forth below.
Comment: While agreeing with the analysis of scoring models
considered in the proposed rule, one commenter asked that CMS consider
including aspects of the Appropriate Care Model (ACM) in the Hospital
VBP program scoring methodology, perhaps by creating a hybrid model in
which a portion of the overall performance score is determined by an
ACM-like measure of patient-level appropriate care.
Response: The ACM, also referred to as the ``all-or-none'' model,
is intended to be a more patient-centric method of assessing hospital
performance on the clinical process of care measures (see 76 FR 2476-
2478).
The ACM creates sub-domains by topic for the clinical process
measures and is distinguished from the other two models described in
the Hospital Inpatient VBP Program proposed rule (namely, the Three-
Domain Performance Scoring Model and the Six-Domain Performance Scoring
Model) 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. As discussed in the proposed rule, 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. 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 stated our belief 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. The ACM is
considered to be ``patient focused'' rather than ``opportunity
focused.'' Due
[[Page 26527]]
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-or-nothing
scoring, the ACM approach captures whether a patient received
appropriate care, but it does not describe the extent of lacking care.
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.
We will continue analyzing alternative performance scoring models,
including the ACM, and will consider proposing to implement scoring
models other than the Three-Domain Performance Scoring Model in the
future. As the industry continues to develop sets of measures that
capture many aspects of quality for various conditions, we will seek to
examine more patient-centered scoring methodologies and measures, and
will certainly consider hybrid models such as the one described by the
commenter.
G. Applicability of the Value-Based Purchasing Program to Hospitals
Section 1886(o)(1)(C) of the Act specifies how the value-based
purchasing program applies 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 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'' because they are hospitals located in one of the 50
states. Therefore we proposed 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 proposed that, for purposes of this provision, we would
adjust payments to hospitals as they are distinguished by provider
number in hospital cost reports. We proposed 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.
Comment: Several commenters, including national and state hospital
associations, expressed their support of our proposal to apply the
Hospital VBP program to subsection (d) hospitals in accordance with the
statutory requirement. Clarification was requested regarding whether
critical access hospitals (CAHs) and subsection (d) hospitals that are
in CMS demonstrations for their inpatient payment, such as the Rural
Community Hospital Demonstration Program, are to be included in the
Hospital VBP program.
Response: 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
District of Columbia.'' This does not include IPPS hospitals in Puerto
Rico. We are finalizing that we shall identify these hospitals by the
CMS Certification Number (CCN) of the main Provider (also referred to
as OSCAR number), calculate, and make the payment adjustments based on
this identification.
CAHs are designated under section 1820(c); therefore, consistent
with section 1886(o)(1)(C)(i), which limits participation in the
Hospital VBP program to subsection (d) hospitals, they are ineligible
to participate in the Hospital VBP program.
Hospitals that participate in the Rural Community Hospital
Demonstration Program are subsection (d) hospitals; therefore, the
Hospital VBP program would apply to them. To the extent there are other
demonstrations involving subsection (d) hospitals, we will need to
evaluate each individual demonstration to determine how it might
potentially overlap with the Hospital VBP program.
Comment: Several commenters requested that CMS exempt hospitals in
Maryland from the Hospital VBP program. Commenters described current
quality efforts in Maryland relating to quality reporting, hospital-
acquired conditions, and readmissions. Some stated that ``requiring
Maryland to comply with the federal program in addition to the existing
State programs would be burdensome and duplicative.'' Several
commenters noted that the State intended to submit a report pursuant to
section 1886(o)(1)(C)(iv).
Response: Our proposal was to apply the Hospital VBP program to
acute care hospitals in Maryland paid under the 1814(b)(3) waiver
unless the Secretary exercised her discretion to exempt these
hospitals. We intend to make this the subject of future rulemaking.
Inpatient acute care hospitals located in the State of Maryland 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,
Maryland hospitals continue to meet the definition of a ``subsection
(d) hospital'' under section 1886(d)(1)(B) of the Act because they are
hospitals located in one of the 50 states. While these hospitals are
not subject to the payment reduction under the Hospital IQR program,
all or nearly all of them submit data to Hospital Compare on a
voluntary basis. Therefore, we do not believe that requiring these
hospitals to participate in the Hospital VBP program would create an
additional or duplicative burden for them. Section
[[Page 26528]]
1886(o)(1)(C)(iv) of the Act grants the Secretary discretion to exempt
hospitals paid under section 1814(b)(3) from the Hospital VBP program,
but only 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.'' To facilitate future
rulemaking on this topic, we believe that this report should be
received prior to the Secretary's consideration of whether to exercise
discretion under section 1886(o)(1)(C)(iv) of the Act.
According to section 1886(o)(1)(B) of the Act, the Hospital VBP
program applies to discharges occurring on or after October 1, 2012.
Therefore, in response to public comment, we are adopting the following
procedure for submission of the state report in order for a hospital
within the state to be exempt from the Hospital VBP program: a State
shall submit, in writing and electronically, a report pursuant to
section 1886(o)(1)(C)(iv) in a timeframe such that allows it to be
received no later than October 1, 2011, which is the beginning of the
fiscal year prior to the beginning of FY 2013. The statute requires the
report to describe 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.'' We
request that the report be as specific as possible in describing the
quality (and other) measures included and in describing the results
achieved over an applicable time period, noting that for the initial
report the applicable time period would likely be before and after
implementation of the State program. In response to commenters'
discussion of readmissions-related quality efforts in Maryland, we
point out that 1886(o)(2)(A) specifically excludes measures of
readmissions from the Hospital VBP program.
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 applicable fiscal year. Therefore, any hospital
that is subject to the Hospital IQR program payment reduction because
it does not meet the requirements for the Hospital IQR program will be
excluded from the Hospital VBP program for such 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
applicable percentage increase for the fiscal year. We intend to track
hospital participation in the Hospital IQR program and welcome public
input on this issue.
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 proposed that these hospitals will
still be included in the Hospital VBP program, but that they will be
scored based only on achievement. We invited public comments on this
approach and requested input on how to score 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 proposed to interpret this provision to mean that any
hospital that is cited by CMS through the Medicare State Survey and
Certification process for deficiencies during the performance period
(for purposes of the FY 2013 Hospital VBP program, the performance
period is 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 also proposed 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 statute requires
the Secretary to 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 through 2008 and 2008 through
2009. The researchers tested different minimum numbers of cases 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 finalized Hospital VBP program scoring methodology
aggregates information across all of the 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 between-hospital
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 clinical process measure, the analysis
compared the reliability of clinical process measure scores for
hospitals according to the
[[Page 26529]]
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 clinical process measure was met. Based on this
analysis, we proposed 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.
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 proposed to exclude from hospitals' Total Performance Score
calculation any measures on which they report fewer than 10 cases. We
also proposed to exclude from the Hospital VBP program any hospitals to
which less than 4 of the measures apply.
We also proposed 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. RAND's analysis indicates that
HCAHPS data does not achieve adequate reliability with a sample of less
than 100 completed surveys to ensure that true hospital performance
rather than random ``noise'' is measured. RAND's analysis indicates
that HCAHPS data are significantly below 85 percent reliability levels
across all HCAHPS dimensions with a sample of less than 100 completed
surveys.
As proposed in the Hospital Inpatient VBP Program proposed rule (76
FR 2481), hospitals reporting insufficient data to receive a score on
either the clinical process of care or HCAHPS domains will not receive
a Total Performance Score for the FY 2013 Hospital VBP program.
We solicited 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.
We also note that the independent analysis conducted by Brandeis
only looked at clinical process of care measures and for that reason,
we intended that our proposal for the 10 case and 4 measure minimums
apply only to those measures. We intend to make a separate proposal on
what specific minimum numbers of cases and measures should apply to the
outcome domain in future rulemaking. To the extent that the comments to
the Hospital Inpatient VBP proposed rule pertained to what specific
minimums would be appropriate for the outcome domain, we will take them
into consideration as we develop our proposal. We will address the
comments in this final rule insofar as they relate to what minimum
numbers would be appropriate for the clinical process of care and
patient experience of care domains.
Comment: Some commenters asked if very small hospitals will be
subjected to the 1.0 percent reduction in base operating DRG amounts
without being eligible for value-based incentive payments.
Response: Hospitals to which the Hospital VBP program does not
apply will not receive a reduction to their base operating DRG amounts.
Comment: Many commenters asked that new hospitals not be included
in the Hospital VBP program until they have sufficient time to
implement all of their quality initiatives and begin meeting the
requirements under the Hospital IQR program, and that new hospitals be
given the opportunity to be scored on improvement during their first
year of participation in the Hospital VBP program. Several other
commenters objected to the inclusion of any hospitals that did not have
sufficient measure data from the baseline period with which to
calculate improvement scores, claiming that it would be unfair to deny
these hospitals the opportunity to receive potentially higher scores
based on improvement points. One commenter asked whether a hospital
assigned a CCN in January 2010 would be scored based on a shorter
baseline period or scored based only on achievement.
Response: We recognize the commenters' concerns regarding the fair
treatment of all hospitals in the Hospital VBP program and the desire
that all hospitals be given the opportunity to earn improvement points.
However, we do not believe that we have authority to exclude these
hospitals from the Hospital VBP program; section 1886(o)(1)(C)(ii) of
the Act sets forth specific exclusions to the term ``hospital'' for
purposes of the program, and none of these exclusions relate to
hospitals that do not have baseline performance measure data. If a
hospital does not have a minimum number of cases on a given measure in
the baseline period, then we interpret the hospital to have ``no
measure data from the baseline period'' with which to calculate an
improvement threshold. In such a case, the hospital would not be scored
on improvement for that measure. If, however, a hospital reports the
minimum number of cases during the applicable baseline period on a
given measure--whether such data was obtained throughout the entire
baseline period or only over a portion of such period--then the
hospital's data during the performance period would be compared to its
baseline period performance for the purpose of determining improvement
points for that measure. Hospitals not scored on improvement for a
given measure will still have the opportunity to score up to 10
achievement points on that measure. As noted above, we believe it is
important to include as many hospitals as possible in order to
successfully implement the Hospital VBP program and succeed in
achieving the Hospital VBP program goals. Thus, the program will apply
to hospitals, as that term is defined in section 1886(o)(1)(C)(i), and
provided that none of the exclusions in section 1886(o)(1)(C)(ii)
apply.
Comment: Commenters suggested that CMS should develop a new value-
based purchasing program specific to cancer centers. Other commenters
suggested that CMS consider promoting disease-specific quality programs
across all care settings.
Response: We thank the commenters for their input. We will
certainly take their suggestions under advisement for future quality
improvement efforts. We note that the Affordable Care Act requires the
Secretary to implement a number of new value-based purchasing and
quality reporting initiatives across various health care settings,
including quality reporting programs for cancer care hospitals and
psychiatric hospitals, as well as to develop plans for value-
[[Page 26530]]
based purchasing efforts in the home health and skilled nursing
settings.
Comment: Several commenters requested improvements to or
clarification of the Medicare State Survey and Certification Process
prior to its use in the Hospital VBP program.
Response: We proposed to interpret the statutory exclusion at
Section 1886(o)(1)(C)(ii)(II) to mean that any hospital that is cited
by CMS through the Medicare State Survey and Certification process for
deficiencies during the performance period that pose immediate jeopardy
to patients will be excluded from the Hospital VBP program for the
fiscal year. We proposed to use the definition of the term ``immediate
jeopardy'' that appears in 42 CFR Sec. 489.3. We intend to further
evaluate the application of this definition to the Hospital VBP context
and may make additional proposals related to the ``immediate jeopardy''
exclusion in section 1886(o)(1)(C)(ii)(II) in future rulemaking.
Comment: Many commenters suggested different numbers of minimum
cases for hospitals to be included in Hospital VBP, arguing that 10
cases per clinical process measure are insufficient to produce reliable
measure scores. A number of commenters argued that CMS should use the
same reliability criteria it uses for purposes of displaying measure
information on Hospital Compare for purposes of defining the minimum
case threshold for the Hospital VBP program.
Response: There are currently no minimum case thresholds for the
clinical process of care measures reported on Hospital Compare, and all
clinical process of care data, regardless of sample size, are made
publicly available. We recognize that there is currently a footnote
added where the Hospital IQR reported clinical process of care measure
rates are based on less than 25 cases, and we note that we originally
believed that this footnote was appropriate based on the work we did in
developing the Hospital Compare display parameters for Hospital IQR
data. However, the more recent independent analysis that was completed
as part of the development of the Hospital Inpatient VBP proposed rule
indicates that the clinical process of care measure data is reliable
with fewer than 25 cases, and we plan to revise the footnote on
Hospital Compare.
Comment: Many commenters called on us to publish the independent
analysis we used to determine the appropriate minimum numbers of cases
and measures for the Hospital VBP program.
Response: To the extent that these analyses are not subject to
privilege, we will make available additional information, including the
study results and methods, and will inform the public when such
information is available.
Comment: One commenter asked whether we had considered the impacts
of the proposed measure and case minimums on hospitals' ability to
compete for value-based incentive payments.
Response: As detailed in the Hospital Inpatient VBP proposed rule
(76 FR 2480), we considered many factors when developing the measure
and case minimums, including the reliability of Total Performance
Scores, the number of hospitals included in the program, and the impact
on small hospitals under various scenarios. We believe that reliable
clinical process of care and patient experience of care domain scores
can be generated based on the proposed minimum numbers of cases,
measures, and completed HCAHPS surveys, and that hospitals will be able
to fairly compete for value-based incentive payments.
Comment: Some commenters suggested that we should consider other
performance measures for hospitals with few cases.
Response: We note that section 3001(b)(2) of the Affordable Care
Act requires the Secretary to establish a value-based purchasing
demonstration program for hospitals that are excluded from the Hospital
VBP program because they do not have the minimum number of cases or
measures.
Comment: One commenter suggested that CMS require hospitals to
submit a minimum of 300 HCAHPS surveys per year in order to be included
in Hospital VBP; another commenter questioned whether 100 completed
HCAHPS surveys will still be the minimum number required in the future
should Hospital VBP move to a 12-month performance period rather than
the 9-month performance period finalized for the FY 2013 Hospital VBP
program. Another commenter was concerned that the HCAHPS exclusion of
patients discharged to a nursing home would not permit hospitals to
achieve a sufficient number of completed surveys.
Response: Because of reliability concerns, if a hospital has less
than 100 completed surveys, we will not calculate an HCAHPS performance
score for the Hospital VBP program (and thus will exclude the hospital
from the Hospital VBP program). The requirement for 100 completed
surveys pertains to both the 9 month and 12 month performance periods
as the 100 survey requirement is based upon the reliability of the
data, not the number of calendar quarters. In either time period, we
want to ensure that we have reliable data to measure performance. Using
statistical measures of reliability that calculate the proportion of
the variance in reported hospital scores that is due to true variation
between hospitals, rather than within hospital variation that reflects
limited sample size, HCAHPS data have been found to be unreliable when
a hospital achieves under 100 survey completes.
Patients that are discharged to nursing homes are excluded from the
survey due to numerous problems that have been encountered by HCAHPS
survey vendors and self-administering hospitals in contacting nursing
home patients. We have also found, based on our own research on this
topic, that the response rate for nursing home residents is extremely
low. By increasing their sampling of patients not discharged to nursing
homes, hospitals can achieve a sufficient number of completed surveys.
Based on the comments we received, we are finalizing our proposals
regarding the applicability of the Hospital VBP program to hospitals,
including calculating and making payment adjustments for this provision
using the CCN of the main provider and making payments to each provider
of record. Further, we adopt the procedures noted above for submission
of the report required under section 1886(o)(1)(C)(iv) and note that we
intend to make the question of whether to exempt Maryland hospitals
from the Hospital VBP program the subject of future rulemaking.
We are also finalizing a policy to exclude from a hospital's total
performance score its score on any clinical process measure for which
it reports fewer than 10 cases, and to exclude from the Hospital VBP
program any hospital to which less than 4 of the clinical process
measures apply. We are also finalizing our proposal to exclude from the
FY 2013 Hospital VBP program a hospital that reports fewer than 100
HCAHPS surveys during the performance period. Finally, we are
finalizing our proposal to score hospitals only based on achievement if
we have measure data from the performance period but no measure data
from the baseline period. However, as discussed above, we will
interpret ``no measure data from the baseline period'' to include data
that does not meet the minimum measure and case thresholds that we are
adopting in this final rule for the clinical process of care and
patient experience of care domains. We believe that calculating an
improvement threshold requires at least as much data
[[Page 26531]]
as is required for calculating measure scores during the performance
period in order to ensure valid comparisons between the two periods. We
further believe that the analyses we commissioned to determine the
minimum number of cases, measures, and completed HCAHPS surveys during
the performance period can be appropriately applied to requiring these
minimums in the baseline period to create an improvement threshold.
H. 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 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 FY 2013, the term ``applicable percent''
is defined as 1.0 percent, but the amount gradually rises to 2.0
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 S-shape (logistic
function).
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[GRAPHIC] [TIFF OMITTED] TR06MY11.051
In determining which of these exchange functions would be most
appropriate for translating a hospital's Total Performance Score 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 value-based 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 interpreted this section to mean that
the redistribution of a portion of the IPPS payments 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 all hospitals. As a 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 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 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 Total Performance Score that is 0.1 higher than
another hospital would receive the same increase in its value-based
incentive payment across the entire Total Performance Score 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
[[Page 26533]]
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 proposed to adopt a
linear exchange function for the purpose of calculating the percentage
of the value-based 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 rewards higher performing
hospitals more aggressively than the cube root function, but not as
aggressively as the logistic and cube functions. We proposed 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) of the Act, that the total
amount of value-based incentive payments equal the estimated amount
available under section 1886(o)(7)(A). In other words, we proposed to
set the slope of the linear exchange function for FY 2013 so that the
estimated aggregate value-based incentive payments for FY 2013 are
equal to 1.0 percent of the estimated aggregate base operating DRG
payment amounts for FY 2013. We proposed that 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 solicited public comments
on our exchange function and the resulting distribution of value-based
incentive payments.
We noted in the Hospital Inpatient VBP Program proposed rule that,
in order evaluate the different exchange functions, we needed to
estimate the value-based incentive payment amount. As stated above,
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 low-volume 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 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
solicited 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 2.0 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 percent as the applicable percent. We multiplied
an estimate (described above) of the total aggregate base operating DRG
payments for hospitals as defined under section 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.
The comments we received on this proposal and our responses are set
forth below.
Comment: The majority of commenters, including MedPAC, expressed
support for our proposed linear exchange function with an intercept of
zero during the initial years of the Hospital VBP program. The reasons
cited by these commenters included that a linear exchange function
appropriately incentivizes both high- and low-performing hospitals; it
is more straightforward than the alternative functional forms discussed
in the Hospital Inpatient VBP Program proposed rule (that is cube, cube
root, and logistic); and it provides a relatively more even
distribution of incentive payments. Many commenters indicated that we
should consider revisiting the issue of the exchange function once we
have actual data and experience under an implemented Hospital VBP
program. Some of these commenters, including MedPAC, suggested that
over time we could consider providing stronger incentives to lower
performing hospitals depending on the initial experience and data.
A few commenters did not support the use of the linear exchange
function with an intercept of zero. These commenters indicated that we
need to provide greater incentives to lower performing hospitals in the
initial implementation, such as through the use of a cube root exchange
function.
Commenters also requested transparency with respect to the slope of
the linear exchange function for FY 2013 and the associated issues of
budget neutrality, payment impacts, and the maximum performance-based
payment adjustment that can be made to a hospital's base operating DRG
payment amount. They also requested additional operational detail on
how CMS will distribute the incentive payment
[[Page 26534]]
amounts to the hospitals once they have been determined.
Response: We agree with the commenters who supported our proposed
linear exchange function. It provides all hospitals with the same
marginal incentive to continually improve. It more aggressively rewards
higher performing hospitals than the cube root function, but not as
aggressively as the logistic and cube functions. It is also the
simplest and most straightforward of the mathematical exchange
functions discussed in the Hospital Inpatient VBP Program proposed
rule.
We disagree with the commenters who stated that we need to provide
greater incentives to lower performing hospitals in the initial
implementation of the Hospital VBP program, such as through the use of
a cube root exchange function. At this time we believe it would be
prudent to examine the experience and data from the initial
implementation of the program before considering increasing the
incentives to lower performing hospitals. We note that increasing the
incentives to lower performing hospitals would result in decreased
incentives for higher performing hospitals due to the requirement in
section 1886(o)(6)(C)(ii)(II) of the Act that the total amount
available for value-based incentive payments under section 1886(o)(6)
for all hospitals for a fiscal year be equal to the total amount of
reduced payments for all hospitals under section 1886(o)(7)(B) for such
fiscal year, as estimated by the Secretary.
With respect to the slope of the linear exchange function for FY
2013, we fully intend to provide the final exchange function slope once
our actuaries have the data necessary to calculate it. As noted in the
Hospital Inpatient VBP Program proposed rule (76 FR 2483), our
actuaries will calculate the slope of the linear exchange function for
FY 2013 so that the estimated aggregate value-based incentive payments
for FY 2013 are equal to 1.0 percent of the estimated aggregate base
operating DRG payment amounts for FY 2013. It is not possible for our
actuaries to calculate the final slope of the linear exchange function
until we have the data from the performance period.
As we have indicated previously, we intend to propose a definition
of the base operating DRG payment amount in future rulemaking. We also
intend to provide additional operational detail concerning how
hospitals will receive the value-based incentive payments in a future
rule.
As requested by many commenters, we would consider revisiting the
issue of the exchange function depending on the actual data and
experience under the implemented Hospital VBP program.
Comment: One commenter argued that an increasing proportion of
hospital payments should be tied to performance, eventually even above
the 2.0 percent margin.
Response: Section 1886(o)(7)(C) of the Act provides for an annual
increase in the funding for available value-based incentive payments
from FY 2013 to FY 2017, adjusting the applicable percent of base
operating DRG payments available for value-based incentive payments as
follows: with respect to FY 2013, 1.0 percent; with respect to FY 2014,
1.25 percent; with respect to FY 2015, 1.5 percent; with respect to FY
2016, 1.75 percent; and with respect to FY 2017 and succeeding fiscal
years, 2 percent. In effect, this will tie an increasing proportion of
hospital payments to performance on quality measures. CMS does not have
authority to increase the base DRG operating payment withhold amount
above 2.0 percent.
After considering the public comments, we are finalizing the
exchange function as proposed.
I. Hospital Notification and Review Procedures
Section 1886(o)(8) of the Act 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 DRG payment amount (section 1886(o)(7)(B)(i)) not
later than 60 days prior to the fiscal year involved. We proposed to
notify hospitals of the 1.0 percent reduction to their respective 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 FY 2013. We expect to propose to incorporate this reduction into our
claims processing system in January 2013, which will allow the 1.0
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 performance period would end only six months prior 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 proposed 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 proposed 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 proposed 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 hospital's Total Performance Score. To meet this
requirement, we proposed to publish hospital scores with respect to
each measure, each hospital's condition-specific score (that is, the
performance score with respect to each condition or procedure, for
example, AMI, HF, PN, SCIP, HAI), each hospital's domain-specific
score, and each hospital's Total Performance Score on the Hospital
Compare Web site. We note that we did not propose to use a hospital's
condition-specific score for purposes of calculating its Total
Performance Score under the Three-Domain Performance Scoring Model.
Section 1886(o)(10)(A)(ii) of the Act 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 proposed to derive
the Hospital VBP measures data directly from measure data submitted by
each hospital under the Hospital IQR program. We proposed that the
procedures we adopt for the Hospital IQR program will also be the
procedures
[[Page 26535]]
that hospitals must follow in terms of reviewing and submitting
corrections related to the information to be made public under section
1886(o)(10) of the Act.
With respect to the FY 2013 Hospital VBP program, we proposed 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
proposed 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 proposed to provide hospitals with 30 calendar
days to review and submit corrections related to their performance
measure scores, condition-specific scores, domain-specific scores and
Total Performance Score.
Section 1886(o)(10)(B) requires the Secretary to periodically post
on the Hospital Compare Web site 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 value-based incentive
payment available for the fiscal year involved and the range and amount
of such payments. We proposed to post aggregate Hospital VBP
information on the Hospital Compare Web site in accordance with Section
1886(o)(10)(B) of the Act. We will provide further details on reporting
aggregated information in the future.
The comments we received on this proposal and our responses are set
forth below.
Comment: Some commenters expressed general support for our
proposals to display 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 for the FY 2013 Hospital VBP program, specifically noting time
limitations in the statutory timeline.
Response: We thank commenters for their support.
Comment: Some commenters called on CMS to translate hospitals'
Total Performance Scores into publicly reported data that is meaningful
to consumers and those employers sponsoring health care coverage for
their employees, specifically by listing data not only for Medicare
patients but for all patients. One commenter additionally requested
that hospitals' performance be evaluated and reported on an individual
basis, even if hospitals are commonly owned and operating upon one
license, and, therefore, reporting as one entity. One commenter asked
if CMS will publish hospital-specific incentive payment percentages or
amounts.
Response: As discussed in the Hospital Inpatient VBP Program
proposed rule (76 FR 2484), 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.
We proposed to publish hospital scores with respect to each measure,
each hospital's condition-specific score, each hospital's domain-
specific score, and each hospital's Total Performance Score on the
Hospital Compare Web site. We will make every effort to make the
information presented as usable and clear for public use as possible.
However, we do not plan at this point to make public hospital-specific
incentive payment percentages or amounts because we believe that the
information required to be publicly reported adequately describes each
hospital's individual performance under the program. With respect to
the request that we report performance information for individual
hospitals that are commonly owned, CMS currently receives and displays
data under the Hospital IQR program by CCN number. One CCN number can
apply to multiple campuses of one hospital. Although hospital owners
have chosen to enroll these campuses in the Medicare program as one
integrated hospital rather than as separate hospitals, we are aware
that members of the public tend to view them as separate hospitals. CMS
is currently exploring best methods to make data publicly available for
each campus of multi-campus hospitals operating under one CCN number
and will take this comment into consideration as it seeks to improve
transparency of hospital performance for consumers.
Comment: One commenter suggested that we develop a composite
quality measurement system for the Hospital Compare Web site similar to
the Society of Thoracic Surgeons' Adult Cardiac Surgery Database.
Response: We thank the commenter for the suggestion. We are
continuing to look for ways to decrease the reporting burden to
hospitals and make the information that we include on Hospital Compare
meaningful for consumers. We will take the suggestion under advisement.
Comment: Commenters questioned how the Hospital VBP program would
ease reporting burdens and aid consumers if, although hospitals are
required to report measure data, some of the data reported would not be
made publicly available on Hospital Compare.
Response: We note that all data used to evaluate hospital
performance in Hospital VBP will also be submitted by hospitals under
the Hospital IQR program. Accordingly, the Hospital VBP program does
not impose reporting requirements on hospitals in addition to or
different from those imposed by the Hospital IQR program. We believe
that the data as reported on Hospital Compare adequately reflects each
hospital's performance without miring the consumer in too much detail.
As discussed above, consumers will be able to see each hospital's score
with respect to each measure, each hospital's condition-specific score,
each hospital's domain-specific score, and each hospital's Total
Performance Score on the Hospital Compare Web site. We are aware that
the score for a measure for purposes of the Hospital VBP program might
differ from the rate we display for that measure for purposes of the
Hospital IQR program based on differing date ranges used for each
program and the fact that the Hospital VBP data will reflect a
hospital's performance score on the measure. We will make every effort
to ensure that these differences are clearly explained to the public.
Comment: Many commenters asked that frequently updated calculations
be provided for each hospital. Some commenters specifically asked for
quarterly hospital preview reports with a percentile ranking for each
hospital. Other commenters suggested CMS make available a report
through QualityNet that would provide constant updates and status about
value-based purchasing scoring calculations and each hospital's
individual and up-to-date scores.
Response: We believe that yearly updates of Hospital VBP
performance information will provide the most simplicity and clarity
for hospitals, although we will certainly consider commenters'
suggestions as the program moves forward. We note that Total
Performance Scores are based on measure data from the entirety of the
performance period, not any subset. We are concerned that providing
hospitals with a calculation of their scores based on only a portion of
the performance period would be misleading because the scores would be
based on insufficient data and could be significantly different from
the hospitals' Total Performance Scores, which will be based on data
from entire performance periods. For
[[Page 26536]]
these reasons, we believe calculating Hospital VBP scores based on the
data from the entire performance period will provide hospitals with the
best and most reliable information for their use.
Comment: Some commenters asked CMS to provide the final, adjusted
DRG payments 30 days before October 1, 2012 to avoid claims
reprocessing for the value-based incentive payments.
Response: 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 proposed to notify hospitals of the 1.0 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 1.0 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 finalized nine-month performance period will end only
six months prior to the beginning of FY 2013, we will not have enough
time to calculate 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
proposed 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 proposed
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 proposed 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.
We made these notification proposals because we concluded that
using a full year as the FY 2013 performance period would not give us
sufficient time to calculate the total performance scores and value-
based incentive payments, notify hospitals regarding their payment
adjustments, and implement the payment adjustments.
While we generally agree with commenters' suggestion, we believe
our finalized performance period and notification policies outlined
above appropriately balance the need for a robust FY 2013 performance
period with hospitals' desire to receive value-based incentive payments
as quickly as possible.
Comment: One commenter asked how often the rankings for each
hospital, based on individual Total Performance Scores, will be
updated. The commenter also asked if there will be a data backlog for
such rankings, and, if so, how great.
Response: We have not proposed to provide ``rankings'' of hospitals
based on their Total Performance Scores. Rather, the hospitals' Total
Performance Scores will be calculated annually at least 60 days prior
to the beginning of the fiscal year. As stated above, because the Total
Performance Scores depend on the entirety of hospitals' data submitted
during the performance period, we do not believe that providing more
frequent updates to the Total Performance Scores than on an annual
basis would be helpful to providers or the public.
While there is a delay between the conclusion of the performance
period and the beginning of the fiscal year in which the corresponding
value-based incentive payments will be made, this time period is
necessary for hospitals to submit the required data, for that data to
be validated, for hospitals to review and submit corrections to
information that will be made public, and for us to calculate Total
Performance Scores. We do not view this delay as a ``backlog,'' which
we would interpret in this context as an extraordinary delay in data
submission, validation, processing and notifications to hospitals.
As noted above, we will provide further details on information to
be made public with respect to hospitals' performance scores in the
future. We will consider the commenter's implicit suggestion that we
should provide rankings in the future.
After considering the public comments, we are finalizing the
notification and review provisions of the Hospital Inpatient VBP
Program proposed rule as proposed.
J. 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) of the Act, 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 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 solicited public comment, in general, on the structure and
procedure of an appropriate appeals process. Specifically, we solicited
comment on the appropriateness of a process that would establish an
agency-level appeals process under which CMS personnel having
appropriate expertise in the Hospital VBP program would decide the
appeal. We sought insight on what qualifications such personnel should
hold. We solicited comment on how the appeals process should be
structured. Finally, we solicited public input on the timeframe in
which these appeals should be resolved.
The comments we received on this proposal and our response are set
forth below.
Comment: Many commenters called on us to establish an appeals
process as soon as possible or prior to FY 2012. Others provided
suggestions on the proper form of an appeals process, including a peer-
reviewed process similar to QIOs or an informal dispute resolution
process such as that outlined in the CMS State Operations Manual, 7212.
[[Page 26537]]
Response: We thank commenters for their input. These comments will
inform future rulemaking on this issue.
K. FY 2013 Validation Requirements for Hospital Value-Based Purchasing
In the FY 2011 Inpatient Prospective Payment System (IPPS) final
rule (75 FR 50225 through 50230), we adopted a validation process for
the FY 2013 Hospital IQR program. We proposed 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,
or a subset of, 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.
We note that we recently proposed to shorten the timeframe for
submitting medical records for purposes of validation under the
Hospital IQR program from 45 days to 30 days. Details regarding that
proposal can be found in the FY 2012 IPPS/LTCH PPS proposed rule
scheduled for publication on May 5, 2011.
The comments we received on this proposal and our responses are set
forth below.
Comment: A number of commenters expressed support for our proposal
on data validation.
Response: We thank the commenters for their input.
Comment: Some commenters requested information on how the data
validation processes for Hospital VBP would be run and, if issues
regarding validation arose, how such problems would be addressed.
Response: We interpret the comments to request more information on
validation scoring, sample selection, medical record request deadlines,
and measures included in the validation process. Details regarding the
validation process that we have adopted for the FY 2013 Hospital IQR
program, as well as the change that we recently proposed to adopt for
that process, can be found in the FY 2011 IPPS/LTCH PPS final rule (75
FR 50225 through 50230) and in the FY 2012 IPPS/LTCH PPS proposed rule
scheduled for publication on May 5, 2011. The public section of the
QualityNet Web site (http://www.qualitynet.org) also contains
additional technical information about the validation process. As we
stated in the Hospital Inpatient VBP Program proposed rule, we believe
that using this process for both the Hospital IQR program and the
Hospital VBP program will be 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
or a subset of 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. The
data validation for the proposed baseline period was completed at the
end of January 2011.
Comment: Some commenters suggested that CMS should conduct targeted
validation, studying the overall accuracy of hospitals' calculation of
measure performance rather than assessing accuracy of every data
element.
Response: As we explain in the FY 2011 IPPS/LTCH PPS Final Rule (75
FR 50225 through 50230), the validation process we have adopted for the
Hospital IQR Program uses every data element used to calculate chart
abstracted quality measures to assess overall measure accuracy. We
interpret the comment to request that we target hospitals for
validation that have attained high measure rates, high performance
scores, and/or a very high number of improvement points as part of
their Hospital VBP total performance score calculation. We believe that
targeting validation on the subset of hospitals achieving high
performance scores and the highest performance score changes from
previous performance periods would improve the data accuracy under the
Hospital VBP program. We will consider this suggestion for future
rulemaking.
Comment: A commenter asked how we will validate data submitted from
hospitals during the initial baseline period.
Response: We interpret this comment to question our validation
process for the FY 2013 proposed baseline period for chart abstracted
clinical process of care measure data from July 1, 2009 to March 31,
2010. We validated the Hospital IQR data for the 3rd calendar quarter
2009 discharges using the validation process that we adopted in the FY
2010 IPPS final rule (73 FR 43882 through 43889) for the FY 2011
payment determination and for 1st calendar quarter 2010 discharges
using the validation process that we adopted in the FY 2011 IPPS final
rule (75 FR 50225 through 50229) for the FY 2012 payment determination.
The 4th calendar quarter of 2009 was not among the quarters of data
that were used for validation of the FY 2011 or FY 2012 payment
determinations. Accordingly, we used the process that we adopted for
the FY 2012 payment determination to validate data from this calendar
quarter. We completed validation of these data in January 2011.
Comment: A number of commenters suggested that we consider the
impact of the ICD-10-CM/PCS reporting implementation on the Hospital
VBP program, measure rates, and quality improvement efforts.
Response: We interpret the comment to request additional
information on the impact of ICD-10/CM/PCS implementation on Hospital
VBP measure populations changing from ICD-9 codes to using ICD-10
codes. While the change in codes used for measure calculation may have
some impact on measure rates, this will not happen until the transition
to ICD-10 on October 1, 2013. We have not modeled this impact on
Hospital VBP measures using statistical analysis at the present time.
We will closely monitor the impact of ICD-10 implementation on the
Hospital VBP program measure achievement and improvement trends and
consider this information in future rulemaking. We agree that this
fundamental change in categorizing diagnoses and procedures could
potentially impact Hospital VBP performance scores through changes in
measure rates due to measure population definition changes and coding
definition changes. Additional information regarding ICD-10
implementation can be found at: http://www.cms.gov/ICD10.
Comment: Some commenters argued that the proliferation of different
electronic reporting requirements and programs and differing chart-
abstraction practices may result in inconsistent data collection by
hospitals.
Response: We appreciate the comment and understand that differences
in abstraction practices and increased use of electronic health records
may result in inconsistent interpretations of measure instructions
among hospitals in terms of data collection. A principal goal of our
validation requirement is to ensure consistency and accuracy in
hospital reported measures. We currently validate the accuracy of
chart-abstracted measure data reported for the Hospital IQR program
and, as explained above, will use this validation process to
[[Page 26538]]
ensure the accuracy of the Hospital VBP chart-abstracted measure data.
After considering the public comments, we are finalizing our
proposal to use the validation process we use for the FY 2013 Hospital
IQR program to ensure that data for the FY 2013 Hospital VBP program
are accurate.
L. Additional Information
1. Monitoring and Evaluation. As part of our ongoing effort to
ensure that Medicare beneficiaries receive high-quality 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 us to
address any disruptions in access or quality that may arise. These
ongoing monitoring and evaluation efforts will be part of our larger
efforts to promote improvements in quality and efficiency, both within
CMS and between CMS and hospitals in the Hospital VBP program.
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 electronic health
records (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)(iii) 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 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. All clinical quality measures selected for the EHR
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. The final rule for the Medicare and
Medicaid EHR Incentive Programs includes 15 clinical quality measures
for eligible hospitals and critical access hospitals (75 FR 44418), two
of which have been selected for the Hospital IQR program under section
1886(b)(3)(B)(viii) of the Act for the FY 2014 payment determination
(75 FR 50210 through 75 FR 50211).
Thus, the Hospital IQR and Hospital VBP programs have important
areas of overlap and synergy with respect to the EHR-based reporting of
quality measures under the HITECH Act. We believe the financial
incentives under the HITECH Act for the adoption and meaningful use of
certified EHR technology by hospitals will encourage greater EHR-based
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 final rule do not implicate or
implement any HITECH statutory provisions. Those provisions are the
subject of separate rulemaking and public comment.
The comments we received on this proposal and our responses are set
forth below.
Comment: Many commenters expressed support or encouragement of EHR
use for quality improvement efforts.
Response: We thank commenters for their support.
Comment: Some commenters argued that EHR use in hospitals does not
mean that quality of care is improving.
Response: We thank commenters for their input. We agree with
commenters' point that possessing electronic health records alone does
not constitute quality improvement. However, the criteria for
``meaningful use'' certified EHR technology are intended to encourage
actual improvements in medical care quality associated with health
information technology rather than simple possession of new systems. As
stated in the Hospital Inpatient VBP proposed rule (76 FR 2485), we
believe that electronic reporting of measure information is a necessary
step towards a more integrated health care system
[[Page 26539]]
and one we intend to encourage in future Hospital VBP rulemaking.
Comment: Some commenters requested clarification on the interaction
of the Hospital VBP program initiatives with the EHR incentive
programs.
Response: We appreciate the commenters' request. We are actively
planning to synchronize the various reporting programs in order to
ensure harmony amongst measures across various settings. We hope to
have all measure data submitted via EHRs in the future.
Comment: One commenter suggested that CMS ensure that value-based
purchasing initiatives foster innovative, quality care with an adequate
level of reimbursement for innovative medical technologies.
Response: We thank the commenter for this observation and believe
that the Hospital VBP program will drive high quality care for Medicare
beneficiaries, including through the provision of innovative
technologies and EHRs. As stated above, we will closely monitor the
Hospital VBP program for effects on the provision of medical care and
on changes to medical practices, including the appropriate use of
medical technologies.
Comment: Many commenters suggested that CMS coordinate with the
Office of the National Coordinator for Health IT (ONC) so that quality
reporting and value-based purchasing data can be collected from
certified EHR technology and related health information systems rather
than manually extracted from medical records and submitted through a
CMS Web site. Many commenters suggested that the first steps in
coordination between CMS and ONC should be to clarify the goals and
harmonize the measure specifications between CMS quality reporting and
value-based purchasing efforts and ``meaningful use.''
Response: We believe that using the same specifications for
similarly-constructed measures for ``meaningful use'' and value-based
purchasing initiatives would reduce confusion from multiple overlapping
measures, reduce the costs of developing measures and could potentially
address the limitations of CMS data collection methods that impact the
ability to risk-adjust measures and distinguish outcomes that are
present on admission.
We agree that data required for quality reporting and value-based
purchasing should be collected primarily from certified EHR technology
rather than manually extracted from medical records when at all
possible. We believe that collecting and transmitting data in this
fashion will, in the long term, reduce provider reporting burden, as
well as improve the reliability of the data used for public reporting
and value-based purchasing. In achieving this objective, we will
continue to engage the ONC on a myriad of operational issues and
challenges that will need to be addressed when aligning value-based
purchasing and ``meaningful use,'' including harmonizing the
specifications of overlapping measures between ``meaningful use'' and
value-based purchasing programs and considering developing new policies
to protect patient privacy when accessing EHR data.
M. QIO Quality Data Access
In the proposed rule (76 FR 2485), we explained the various changes
that have occurred since the QIO program regulations were first issued
in 1985 (see 50 FR 15347, April 17, 1985). These include the
significant technological changes that have occurred in the last 25
years; the addition of new responsibilities performed by QIOs; changes
in the way QIOs-- and CMS--conduct business; the establishment of new
laws to protect data and information, including the Health Insurance
Portability and Accountability Act of 1996 (HIPAA) and the Federal
Information Security and Management Act (FISMA); the need for improved
transparency and focus on quality health care and patient safety; and
the realization that CMS needs improved access to better manage and
oversee the QIOs. We also noted that these same regulations govern data
and information held by End Stage Renal Disease Networks in accordance
with section 1881(c)(8) of the Act.
In light of the above, we proposed several changes to the QIO
regulations. Specifically, we proposed amending the definition of the
QIO review system in Sec. 480.101(b) to include CMS; modifying Sec.
480.130 to clarify the Department's general right to access non-QRS
confidential and non-confidential information; removing the onsite
limitation placed on CMS' access to QIO internal deliberations in Sec.
480.139(a); and similarly modifying Sec. 480.140 to eliminate the
onsite restriction to CMS' access to Quality Review study (QRS) data.
We also proposed making corresponding changes in Sec. 422.153 to
ensure consistency with Sec. 480.140. In addition, we asked for
comments regarding whether the ``onsite'' restriction should be
eliminated entirely from subparagraph (a) of section 480.140 so that
other entities who already have access to this information can obtain
it without going to the QIO's site. We also asked for comments on
whether researchers should be allowed access to QIO information and the
process, including criteria, which should be used to approve or deny
these requests.
The comments we received on these changes and our responses are set
forth below.
Comment: We received comments expressing concern that the changes
to the QIO confidentiality regulations strip many of the
confidentiality safeguards and go against Congress' original intent in
establishing the confidentiality requirements contained in section 1160
of the Social Security Act. These comments included concerns that
making CMS part of the review system and providing CMS with access to
confidential QIO deliberations and QRS information would make the
information subject to the Freedom of Information Act (FOIA); would not
provide ``adequate protection'' as required by section 1160; would
violate other laws, such as the Health Insurance Portability and
Accountability Act (HIPAA); and may result in patient, physician, and
provider information being released much more broadly than Congress
intended, including potential releases of information during discovery
in civil proceedings. Other commenters believed that there could be
serious unintended consequences for patients, physicians, and
providers, including damage to professional reputations.
Response: We thank the commenters for their concerns. While section
1160 does provide a general framework for maintaining the
confidentiality of data or information acquired by QIOs, the section
gives the Secretary broad discretion on when disclosures are necessary
and appropriate. Paragraph (a)(1) provides that disclosures can be made
``to the extent that may be necessary to carry out the purposes of [the
QIO statute], * * *'' Paragraph (a)(2) gives the Secretary authority to
allow disclosures in such cases and under such circumstances as the
Secretary provides for in regulations to assure the adequate protection
of the rights and interests of patients, physicians and providers. As
we discussed in the proposed rule, the initial regulatory framework was
developed at a time when computers were in their infancy and the work
of the QIOs was performed onsite at provider and physician facilities.
However, as technology has advanced and the QIOs' workload has
expanded, what was deemed ``adequate'' 25 years ago is no longer the
case. CMS has
[[Page 26540]]
weighed the concerns of the commenters against the needs of the QIO
program, as well as other benefits CMS will gain from these changes. We
have determined that the benefits resulting from these changes are
extremely important at this time. We believe that these changes are
necessary to modernize the regulations to equate with the manner in
which QIOs carry out their work. In addition, these changes take into
account the increased focus on medical errors and patient safety, which
continue to be a major focus of the QIO program and of CMS. These
changes, particularly the expanded definition of ``QIO review system,''
acknowledge the key role CMS plays in quality improvement, including
CMS' role in the Hospital Value Based Purchasing Program, the Hospital
Inpatient Quality Reporting Program, and the Hospital Outpatient
Quality Data Reporting Program. We also recognize that conveying
additional kinds of QIO confidential information to CMS will result in
the information being subject to the Freedom of Information Act (FOIA);
however, protections remain within FOIA for protecting certain kinds of
confidential information from further disclosure. In obtaining any
information, CMS strives to adhere to all legal requirements, including
those specified in HIPAA and in the Federal Information Security and
Management Act (FISMA). Our goals are, among others, to achieve
improved management and oversight of the QIO program and greater
transparency of physician and provider care. We recognize that these
goals must be accomplished while continuing to ensure that QIOs are
able to effectively develop reliable methods for identifying medical
errors and attain overall improvement in the quality of health care
provided to patients.
Comment: Several commenters expressed concerns regarding the
negative impact the changes to the confidentiality regulations, and in
particular CMS' expanded access to QIO information, could have on the
QIO program. Some commenters suggested that the changes could place the
entire QIO review process--and the QIO program--in jeopardy. Some
believed that the changes are not in line with the original intent of
the confidentiality provisions, which was to ensure ``frank and open
communication'' and that the ability of the QIOs to attain quality
improvement would be undermined. Others believed that the changes could
create an environment where every discussion between the QIO and a
provider or physician would take place in the presence of the
provider's or practitioner's legal counsel in an attempt to ensure that
the provider or practitioner does not reveal potentially damaging
information. Still others believed the changes could result in
attorneys using the QIO process as a ``screening'' tool, gaining access
to QIO information to decide whether a lawsuit against an individual or
entity identified in the information might be appropriate, or whether
the information might bolster an existing suit. The commenters also
mentioned that access to QIO information might subject QIO staff to a
lawsuit when a jury's decision ultimately differs from that of the QIO.
In addition, QIOs attempting to mediate and/or resolve concerns or
complaints could see less willingness by beneficiaries, physicians, and
providers to engage in these discussions in light of concerns that
information and outcomes may become discoverable and that this could
ultimately impact patient safety. In fact, at least one commenter
suggested that providers and physicians could be less likely to
participate in programs associated with other Federal agencies, such as
the Center for Disease Control, and Prevention's work associated with
Healthcare Acquired Infections. Concerns were also raised regarding the
ability of QIOs to hire physician reviewers should the names of
physician reviewers and their conclusions about the quality of care
provided by other physicians and providers become discoverable and that
this could drive up costs associated with hiring these physician
reviewers.
Response: QIOs perform numerous reviews through their contracts
with CMS, including quality of care reviews, medical necessity reviews,
readmission reviews, higher-weighted diagnosis related group reviews,
appropriateness of settings reviews, admission reviews, as well as
appeals of beneficiary discharges from a variety of provider settings.
In carrying out these reviews, the QIOs rely on medical and other
relevant information supplied by providers, physicians and
beneficiaries, and these providers and physicians are required by law
to provide QIOs with relevant information upon request. In fact, the
QIO regulations at Sec. 480.130 already provide, without any
amendments, that the Department of Health and Human Services (including
CMS) has full access to all QIO confidential information--except
information that qualifies as QRS data and internal deliberations. As
such, we do not anticipate that QIO core review operations will be
impacted in any significant way through the changes to the
confidentiality regulations. Moreover, while reference was made to a
potential negative impact on participation in other Federal programs,
the exact nature of this impact was not clear and again, in light of
the Department's existing access, we do not believe that the
commenters' concern is likely. Quality Review Studies is the one area
in which the changes could potentially have an impact on provider and
physician participation; however, we do not believe that the changes
will have the profound impact envisioned by these commenters. In light
of CMS' role in paying claims and the substantial amount of claims data
already in CMS' possession, requestors can already obtain certain
information from CMS's Privacy Act Systems of Records related to
providers and physicians from which conclusions about their performance
could be gleaned. This is in addition to the performance information
that is already made available on providers and physicians through the
various quality reporting programs. CMS' goal is not to serve as the
repository of all QIO data and information. We recognize that
responsibility is best left to the QIOs, and we are cognizant of the
concerns expressed by the commenters. To the extent that we are going
to collect information that will be retrieved by an individual's
personal identifier including name, social security number, etc., we
will publish a CMS Privacy Act System of Record notice in the Federal
Register. However, at this time we have not identified such a need.
Additionally, CMS does not disclose patient identifiable data to third
party FOIA requesters and will protect this information to the extent
allowed by Federal law. As we have noted, one of our major goals is to
improve the management and oversight of the QIOs. We do not intend to
interfere in the relationships between the QIOs and physicians,
providers, etc.
Although providers and physicians could conceivably engage legal
counsel, this does not appear likely, particularly given the nature of
the review process as detailed below. Providers and physicians have
always had the right to consult with their counsel but have not
routinely enlisted such assistance. We believe that this is because of
the QIOs' statutory right to medical information, which is normally
maintained in the medical records. Moreover, while the impact of the
changes will place more emphasis on information in CMS' possession,
section 1157(b) of the QIO statute protects the QIO and its employees
from being held to have violated a criminal law or be civilly
[[Page 26541]]
liable for performing its statutory and contractual responsibilities,
provided due care was exercised. Additionally, while the changes
provide CMS with the right to obtain more data off-site, they do not
mandate that CMS receive every piece of information in the QIOs'
possession, and we will make determinations regarding information
needed in line with our stated goals, as articulated above. As such, we
do not anticipate routinely obtaining the names of physician reviewers
or other information associated with QIO deliberations unless that
information is pertinent to a specific identifiable performance
initiative.
Comment: Some commenters expressed concern that there could be a
lack of control over disclosures once confidential information is
provided to other Federal and state agencies and that robust systems
are needed to prevent inherent dangers associated with multiple ``hand-
offs'' of information from agency to agency so that the necessary level
of responsibility and oversight is maintained and information is not
lost, misused or inappropriately disclosed. In addition, a concern was
raised that QIO information represents only a subset of all data and
information and that CMS and other agencies must consider that the
information does not represent the ``norm.'' In particular, commenters
raised concerns that the expanded access to quality improvement review
activity would allow CMS to use QIO data to determine new methodologies
to reduce or deny payments for other initiatives, such as the expansion
of the Recovery Audit Program.
Response: We appreciate the comments regarding the need for
internal controls related to information provided to other Federal and
state agencies. However, QIOs already have the authority to release
confidential information to Federal and state agencies in certain
instances as defined by the QIO confidentiality regulations in Part 480
(for example, the Office of Inspector General, Federal and State fraud
and abuse agencies, and Federal and State agencies responsible for
risks to the public health), and necessary controls are already in
place to effectuate these provisions and ensure the data is
appropriately protected. We believe that any additional controls
associated with the potential increased access by Federal and state
agencies can be handled through the development of additional program
instructions and policy statements. Moreover, CMS already has a well-
defined process in place to ensure protection of various types of
information, including limited data sets, identifiable data, and claims
data in general, and this includes adherence to specific information
technology requirements, as well as HIPAA and FISMA. As we have noted,
our goal in expanding the access is, in part, to ensure appropriate
oversight and management of the QIO program. However, we recognize that
access to this information could have additional benefits and improve
our understanding of payment related problems. This includes the
ability to use QIO data to determine new methodologies to reduce or
deny payments for other initiatives, such as recovery audits. In
utilizing the data, we also recognize that careful analysis will need
to be conducted to ensure that the scope of the data is clearly
recognized so that inaccurate conclusions are not drawn based on the
particular ``subset'' of data being used.
Comment: We received comments advising that making confidential QIO
information available to researchers would undermine the QIO program
and could drive Hospitals to cease participating in QIO activities.
Some commenters recognized that while sharing this data may be
beneficial and increase opportunities for improvement within our health
care systems, the data and process for obtaining the data could be
easily mismanaged if well-defined parameters are not put into place for
approving these requests, including the establishment of detailed
criteria that ensures the research has value to CMS' and is in line
with CMS' goals, and that the research be conducted by credible
research entities. Still others commented that QIOs should share only
aggregate level data or de-identified data and that rigorous assurances
and safeguards be put in place to ensure patient privacy and
confidentiality.
Response: We appreciate the comments and suggestions regarding the
release of information to researchers. As discussed previously, QIOs
perform numerous reviews through their contracts with CMS, including
quality of care reviews, medical necessity reviews, readmission
reviews, higher-weighted diagnosis related group reviews,
appropriateness of settings reviews, admission reviews, as well as
appeals of beneficiary discharges from a variety of provider settings.
In carrying out these reviews, the QIOs rely on medical and other
relevant information supplied by Medicare providers, physicians and
beneficiaries, and these providers and physicians are required by law
to provide QIOs with medical and other relevant information upon
request. As such, we do not anticipate that most QIO core review
operations will be negatively impacted through the changes to the
confidentiality regulations. As previously mentioned, although there
could be some potential impact on participation in Quality Review
Studies, our hope is that the focus will remain on the patients and the
quality improvements that can be achieved through these studies.
Additionally, the potential benefits attained through the efforts of
researchers are significant, particularly as we aim to improve patient
safety by reducing medical errors. We recognize that these requests
should be thoroughly evaluated, with the release of information based
on well-defined criteria. CMS already employs the CMS Privacy Board to
review researchers' requests for CMS claims data. The Board reviews the
request, and ensures that the request would comply with applicable
privacy and security laws and CMS policies governing data disclosure.
Only after an affirmative finding is the data released to the
researcher. We believe that we should use the CMS Privacy Board to
process research requests for QIO data as well. After consideration of
the public comments, we have added Sec. 480.144 to allow CMS to
approve requests from researchers for access to QIO confidential
information.
Furthermore, even after the Board determines that the disclosure
would comply with applicable laws and CMS' policies, data is only
released upon execution of a data use agreement (DUA). These agreements
spell out the expectations on data transmission, storage, access, use,
re-use and disclosure to downstream entities. CMS conditions research
data disclosures on the researchers' acceptance of these terms. DUAs
therefore provide ongoing protection of the data after it is released.
Moreover, in order to fully leverage the capabilities of these
researchers, it is imperative that full access be given in those
situations in which the CMS Privacy Board deems warranted. Our goal
will be to develop sub-regulatory requirements, including any
additional criteria and requirements necessary to properly evaluate
these requests to coincide with the effectuation of this Final Rule.
Comment: We received comments in support of CMS's proposed changes
to the regulations governing QIOs, including those providing CMS with
broader access to QIO data and the deletion of the ``onsite''
requirement for CMS and other Federal and state agencies having the
right to access the data. These commenters believed that any entity
that is entitled to have access to QIO information should be able to
get the information without going onsite to
[[Page 26542]]
the QIO. The commenters considered the technological advances since
1985 considerable and that new Federal legislation, including HIPAA and
FISMA, have made the ``on-site'' requirement obsolete. Others supported
making CMS an identified part of the definition of a ``QIO review
system'' because this would assist CMS in becoming more efficient in
exchanging data and enable CMS to better manage and respond to new
information. These comments also supported CMS' modification of Sec.
480.139 and Sec. 480.140 to facilitate CMS' communication with, and
awareness of, QIO activities needed to improve the proper oversight and
management of QIOs and the timely access to information.
Response: We thank these commenters for the support. The changes
are designed to improve our oversight and management of the QIOs while
also better utilizing available data to oversee patient care, and where
feasible the Medicare program. We see the recognition of CMS' role in
the QIO review system as an important step towards achieving this goal.
Moreover, as we conveyed in the Hospital Inpatient VBP Program proposed
rule, 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 the elimination of the
restriction that data can only be accessed onsite at the QIO by CMS in
sections 480.139 and 480.140. For the same reasons, we believe that the
onsite restriction should be eliminated for all Federal and state
agencies having access to QIO data as specified in section 480.140. In
implementing these changes and allowing improved access to this
information, CMS will ensure adherence to all legal requirements,
including HIPAA and FISMA, and we will establish policies and
procedures to ensure appropriate protections are in place in response
to the deletion of the onsite requirement from sections 480.139 and
480.140.
Comment: We received several comments in support of giving
researchers access to QIO confidential information. Many believed this
access would enable researchers to study quality issues and obtain
needed insights into ways health care quality could be improved.
Commenters also supported leveraging the current CMS Privacy Board
structure to evaluate these requests. Others suggested that the process
for accessing QIO data be given free of lengthy delays or cumbersome
process requirements for approval of these requests. It was also
suggested that an expedited process be created that would grant
individual QIOs with the authority to independently assess and release
information, would incorporate tightly managed data use agreements and
would also allow requestors to appeal declinations to the CMS Privacy
Board. Alternatively, comments were received suggesting that CMS
utilize a review process similar to ``investigational review boards''
or the ``Limited Data Set Date process.''
Response: We appreciate these comments and agree with the positive
insights that could be attained by allowing researcher access to QIO
data as well as the benefits of using the already established CMS
Privacy Board. Although we have considered other options for evaluating
these requests, we believe that using the existing CMS Privacy Board
gives us the best opportunity to ensure that all requests are
appropriately evaluated in a timely fashion. As necessary, we will
consider potential modifications to the specific criteria and processes
employed by the CMS Privacy Board should circumstances warrant such
changes. Moreover, with regard to the suggestion that QIOs be used to
evaluate these requests, we believe that this would create a
substantial workload burden for QIOs and could potentially result in
different decisions on similar requests, along with the potential for
``forum-shopping'' for those who have had their requests denied by
individual QIOs. While we recognize that other models may exist to
evaluate these data requests, we believe the use of the CMS Privacy
Board represents the best opportunity to ensure requests are properly
and uniformly adjudicated, without placing an undue burden on
individual QIOs.
Comment: One commenter requested a change to the QIO
confidentiality regulations related to the right of an attending
physician to unilaterally decide not to release individual case review
results to beneficiaries if the attending physician determines the
results could ``harm'' the beneficiary. The commenter suggested that
the regulatory requirement be changed to allow providers to comment on
these determinations and that the QIO ``finding'' be available to the
beneficiary in all circumstances and that these changes are important
for improvements to the patient, physician and provider relationships.
Response: While we appreciate this suggestion, we believe that it
is outside the scope of this Final Rule. As such, we are not taking any
action at this time. However, we reserve the right to consider this
issue in future rulemaking.
After consideration of the public comments, we are finalizing the
proposed changes to the QIO program regulations. In addition, we are
eliminating the ``onsite'' restriction on Quality Review Study
information in Sec. 480.140(a) so that all of the entities and
individuals listed in that provision are no longer subject to it. We
are also establishing regulations governing the ability of researchers
to request access to QIO confidential information.
III. Collection of Information Requirements
We will submit a revised information collection and recordkeeping
requirements to incorporate CMS access of information from QIOs. CMS
intends to modify existing information collection requirements approved
on behalf of the Hospital IQR program data collection (OMB 0938-1022)
and supporting the Hospital Value Based Purchasing Program, and the QIO
quality of care complaint form (OMB 0938-1102) to QIO program
confidentiality regulation modification. We estimate that the 53 QIOs
will each require approximately 120 hours per QIO per year to modify
information technology systems necessary to grant CMS access to the
requested information, or a total of 6,360 burden hours per year. We
believe that no additional information will be collected from providers
and Beneficiaries as a result of this information collection.
IV. Economic Analyses
A. Regulatory Impact Analysis
1. Introduction
We have examined the impact of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22,
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4,
1999) and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of
[[Page 26543]]
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This rule has been designated an
``economically'' significant rule, under section 3(f)(1) of Executive
Order 12866, and a major rule under the Congressional Review Act.
Accordingly, the rule has been reviewed by the Office of Management and
Budget.
2. 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 will accomplish these goals by providing
incentive payments based on hospital performance on measures. This
final 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 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.
3. Summary of Impacts
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 payment amount'' in
future rulemaking. For purposes of this final 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), as estimated
by the Secretary, resulting in a net budget-neutral impact. Overall,
the distributive impact of this final rule is estimated at $850 million
for FY 2013.
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 will accomplish these goals by providing
incentive payments based on hospital performance on measures. This
final 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 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.
4. Detailed Economic Analysis
Table 10 displays our analysis of the distribution of possible
total performance scores based on 2009 data, providing information on
the estimated impact of this final rule. Value-based incentive payments
for the estimated 3,092 hospitals that would participate 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, row 8 of Table 10
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.
Table 10--Two-Domain Impact (Clinical Process and HCAHPS): Estimated Incentive Rates by Hospital Characteristic [dagger]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percentile
Hospital characteristic --------------------------------------------------------------------------------------------------
N = 3,092 Mean 5th 10th 25th 50th 75th 90th 95th
--------------------------------------------------------------------------------------------------------------------------------------------------------
Region
--------------------------------------------------------------------------------------------------------------------------------------------------------
New England.......................................... 138 1.083 0.660 0.751 0.935 1.088 1.276 1.391 1.434
Middle Atlantic...................................... 370 0.955 0.542 0.619 0.766 0.963 1.152 1.288 1.352
South Atlantic....................................... 518 1.041 0.551 0.661 0.822 1.039 1.255 1.420 1.499
East North Central................................... 475 1.022 0.555 0.652 0.840 1.025 1.214 1.380 1.472
East South Central................................... 301 1.021 0.550 0.634 0.810 1.023 1.235 1.413 1.482
West North Central................................... 248 1.083 0.638 0.721 0.866 1.075 1.283 1.470 1.567
West South Central................................... 457 1.014 0.477 0.597 0.784 0.997 1.248 1.432 1.563
Mountain............................................. 201 0.980 0.584 0.650 0.822 0.986 1.159 1.336 1.396
Pacific.............................................. 384 0.935 0.434 0.551 0.755 0.951 1.126 1.290 1.383
--------------------------------------------------------------------------------------------------------------------------------------------------------
Urban/Rural
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large Urban.......................................... 1,199 1.008 0.552 0.646 0.815 1.014 1.206 1.370 1.449
Other Urban.......................................... 1,010 1.016 0.551 0.646 0.817 1.015 1.209 1.379 1.484
Rural................................................ 883 1.007 0.487 0.607 0.788 1.009 1.239 1.398 1.499
--------------------------------------------------------------------------------------------------------------------------------------------------------
Capacity (by beds)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 to 99 beds......................................... 1,045 1.044 0.491 0.617 0.814 1.047 1.284 1.456 1.575
100 to 199 beds...................................... 939 1.002 0.500 0.598 0.815 1.015 1.201 1.360 1.452
200 to 299 beds...................................... 481 0.989 0.586 0.662 0.803 0.996 1.175 1.323 1.392
300 to 399 beds...................................... 279 0.995 0.577 0.668 0.821 1.022 1.167 1.293 1.379
[[Page 26544]]
400 to 499 beds...................................... 151 0.985 0.575 0.700 0.837 0.982 1.135 1.307 1.414
500+ beds............................................ 197 0.960 0.562 0.652 0.766 0.960 1.146 1.265 1.314
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medicare Utilization
--------------------------------------------------------------------------------------------------------------------------------------------------------
0 to 25%............................................. 237 0.990 0.542 0.639 0.798 1.012 1.164 1.352 1.451
> 25% to 50%......................................... 1,508 1.016 0.528 0.642 0.818 1.020 1.224 1.381 1.459
> 50% to 65%......................................... 1,148 1.005 0.524 0.637 0.804 1.008 1.206 1.381 1.482
> 65%................................................ 196 1.02 0.52 0.60 0.80 1.02 1.28 1.42 1.53
--------------------------------------------------------------------------------------------------------------------------------------------------------
[dagger] Note: Because sufficient 2009 data was not available at the time of publication of this final 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.
Table 11 below shows the estimated percent distribution by hospital
characteristic of the 1 percent reduction ($850 million) in the base
operating DRG payment for fiscal year 2013.
Table 11--Average Estimated Percentage Withhold Amount (as Required by
Section 1886(o)(7) of the Social Security Act) by Hospital
Characteristic
------------------------------------------------------------------------
Estimated
Hospital characteristic N = 3,092 percent withhold
amount
------------------------------------------------------------------------
Region:
New England....................... 138 5.9
Middle Atlantic................... 370 15.9
South Atlantic.................... 518 19.5
East North Central................ 475 17.5
East South Central................ 301 7.8
West North Central................ 248 7.2
West South Central................ 457 10.3
Mountain.......................... 201 4.8
Pacific........................... 384 11.2
Urban/Rural:
Large Urban....................... 1,199 49.8
Other Urban....................... 1,010 38.2
Rural............................. 883 11.1
Capacity (by beds):
1 to 99 beds...................... 1,045 8.1
100 to 199 beds................... 939 21.2
200 to 299 beds................... 481 20.5
300 to 399 beds................... 279 16.9
400 to 499 beds................... 151 11.0
500+ beds......................... 197 23.4
Medicare Utilization:
0 to 25%.......................... 237 3.9
> 25% to 50%...................... 1,508 60.0
> 50% to 65%...................... 1,148 32.8
> 65%............................. 196 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 12. 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). 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 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 12--Projected Number of Hospitals Not Receiving a Hospital VBP
Score in FY 2013, by Hospital Characteristic
------------------------------------------------------------------------
Number of
hospitals not
receiving
Hospital characteristic hospital VBP
score (N =
353)
------------------------------------------------------------------------
Region:
New England.......................................... 6
[[Page 26545]]
Middle Atlantic...................................... 18
South Atlantic....................................... 14
East North Central................................... 31
East South Central................................... 26
West North Central................................... 17
West South Central................................... 85
Mountain............................................. 25
Pacific.............................................. 26
Puerto Rico.......................................... 34
Missing Region....................................... 71
Urban/Rural:
Large Urban.......................................... 116
Other Urban.......................................... 83
Rural................................................ 83
Missing Urban/Rural.................................. 71
Capacity (by beds):
1 to 99 beds......................................... 213
100 to 199 beds...................................... 47
200 to 299 beds...................................... 11
300 to 399 beds...................................... 8
400 to 499 beds...................................... 2
500+ beds............................................ 0
Missing Capacity..................................... 72
Medicare Utilization:
0 to 25%............................................. 78
> 25% to 50%......................................... 75
> 50% to 65%......................................... 43
> 65%................................................ 28
Missing Medicare Utilization......................... 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.
5. Alternatives Considered
The major alternative performance scoring models considered for
this final rule were the Six-Domain Performance Scoring Model and the
Appropriate Care Model, and both of these models were discussed at
length in the proposed rule (76 FR 2476 through 2478).
The Appropriate Care Model (ACM) creates sub-domains by topic for
the clinical process of care measures and is distinguished from the
Three-Domain Performance Scoring Model 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 is 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.
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 broken down into sub-domains
characterized by condition. We would assign intermediate scores to each
hospital for each of the clinical process sub-domains. Like the Three-
Domain Performance Scoring Model, hospitals would be scored on each
measure in the sub-domain and individual measures 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.
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.
6. Accounting Statement
As required by OMB Circular A-4 (available at http://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 final 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 budget-neutral impact. Overall, the distributive
impacts of this final rule, resulting from the incentive payments and
the 1 percent 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 13--Accounting Statement: Classification of Estimated Expenditures
for FY 2013
------------------------------------------------------------------------
Category Transfers
------------------------------------------------------------------------
Annualized Monetized $0 (Distributive impacts resulting from
Transfers. the incentive payments and the 1 percent
reduction (withhold) in the base
operating DRG payment are estimated at
$850 million.)
From Whom To Whom?........... Federal Government to Hospitals.
------------------------------------------------------------------------
B. Regulatory Flexibility Act Analysis
The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, we estimate that the
great majority of hospitals and most other health care providers and
suppliers are small entities, either by being nonprofit organizations
or by meeting the SBA definition of a small business having revenues of
$7.0 million to $34.5 million or less in any 1 year. For purposes of
the RFA, among the 3,092 hospitals that would be participating in the
Hospital VBP program, we estimate that percent increases in payments
resulting from this final rule will range from 0.0236 percent for the
lowest-scoring hospital to 1.817 percent for the highest-scoring
hospital. When the reduction to base operating DRG payments required
under section 1886(o)(7) (one percent in FY 2013, gradually rising to 2
percent by FY 2017) 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 total Medicare 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
[[Page 26546]]
not preparing an analysis under the RFA because the Secretary has
determined that this final 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 604 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 did not prepare an analysis under section
1102(b) of the Act because the Secretary has determined that this final
rule would not have a significant impact on the operations of a
substantial number of small rural hospitals.
Comment: One commenter disagreed with our analysis, which concluded
that the proposed rule will not have an impact on a substantial number
of small, rural hospitals. The commenter argued that quality
improvement efforts are more costly for small hospitals and was also
concerned about the program's reliability in low volume situations.
Response: As discussed throughout the various sections of this
Regulatory Impact Analysis, including the discussions of the RFA and
section 1102(b), and based on the concluding economic impact findings
and tables presented, we believe there will not be a significant impact
on the operations of a substantial number of small rural hospitals.
Absent any new data, commenters may reference the upcoming
demonstration projects such as those required under section 3001(b) of
the Affordable Care Act as a tool for better understanding any new
economic impacts, including those of small rural hospitals. As
described in section II. G. of this Final Rule, we believe that the
measure and case minimums allow us to include as many hospitals as
possible while calculating reliable Total Performance Scores.
Comment: Another commenter asked for more detail in Table 10,
including data to offer a rationale for the incentive rates identified.
This commenter stated that the ``weights have not been defined or
modeled within the rule to allow hospitals to make projections with
budgeting and other operational issues.'' This commenter recommended
that CMS provide additional information so that hospitals can replicate
the process and calculations for planning purposes.
Response: We believe the data on the two-domain impact of the
Hospital VBP program provided in Table 10 are as detailed as possible,
along with the accompanying narrative and analysis provide a
description of the number of affected entities and the size of the
economic impacts of this final rule, as well as the justification for
the Secretary's certification that this final rule will not have a
significant economic impact on a substantial number of small entities.
We will take the commenter's suggestions for providing additional data
under advisement should additional or more detailed data become
available and as we continue public outreach and education efforts for
the Hospital VBP program.
C. Unfunded Mandates Reform Act Analysis
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2011, that
threshold is approximately $136 million. This rule would not mandate
any requirements for State, local, or tribal governments, nor would it
affect private sector costs.
V. Federalism Analysis
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. As stated above, this final rule would not have a
substantial effect on State and local governments.
List of Subjects
42 CFR Part 422
Administrative practice and procedure, Health facilities, Health
maintenance organizations (HMO), Medicare, Penalties, Privacy,
Reporting and recordkeeping requirements.
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 amends 42 CFR chapter IV as set forth below:
PART 422--MEDICARE ADVANTAGE PROGRAM
0
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
0
2. Section 422.153 is revised to read as follows:
Sec. 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 Sec.
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
0
3. The authority citation for part 480 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Subpart B--Utilization and Quality Control Quality Improvement
Organizations (QIOs)
0
4. Section 480.101(b) is amended by revising the definition of ``QIO
review system'' to read as follows:
Sec. 480.101 Scope and definitions.
* * * * *
(b) * * *
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;
[[Page 26547]]
(3) Health care institutions and practitioners whose services are
reviewed;
(4) QIO reviewers and supporting staff;
(5) Data support organizations; and
(6) CMS.
* * * * *
0
5. Section 480.130 is revised to read as follows:
Sec. 480.130 Disclosure to the Department.
Except as limited by Sec. 480.139(a) and Sec. 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.
0
6. Section 480.139 is amended by revising paragraph (a)(1) to read as
follows:
Sec. 480.139 Disclosure of QIO deliberations and decisions.
(a) * * *
(1) A QIO must not disclose its deliberations except to--
(i) CMS; or
(ii) The Office of the Inspector General, and the Government
Accountability Office as necessary to carry out statutory
responsibilities.
* * * * *
0
7. Section 480.140 is amended by revising paragraphs (a) introductory
text, (a)(1) and paragraph (g) to read as follows:
Sec. 480.140 Disclosure of quality review study information.
(a) A QIO must disclose quality review study information with
identifiers of patients, practitioners or institutions to--
(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.
0
8. Section 480.144 is added to read as follows:
Sec. 480.144 Access to QIO Data and Information.
CMS may approve the requests of researchers for access to QIO
confidential information not already authorized by other provisions in
42 CFR part 480.
Authority: Catalog of Federal Domestic Assistance Program No.
93.773, Medicare--Hospital Insurance; and Program No. 93.774,
Medicare--Supplementary Medical Insurance Program.
Dated: April 14, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
Approved: April 26, 2011.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2011-10568 Filed 4-29-11; 8:45 am]
BILLING CODE 4120-01-P