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Quality Briefing Book [1]
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�QUALITY
WORKGROUP 9
BRIEFING BOOK
�FOR OFFICIAL USE ONLY
Table of Contents
I.
Background
U.
Issues
HI.
Recommendations and Rationale
A.
B.
Reporting Standardized Quality Information
D.
Quality Improvement
E.
Conditions of Participation
F.
Strengthening and Streamlining Current Activities
G.
V.
Organization of Quality System
C.
IV.
Summary of Workgroup Proposal
Research/Guidelines/Technology
Assessment
Questions and Answers
Political Considerations
A.
B.
Consumer Groups
C.
Managed Care Industry and Collaborating Business Groups
D.
Accreditation Groups
E.
Quality Experts
F.
Congressional Concerns
G.
VI.
Provider Groups
Medicare Peer Review Organizations
Appendix
�Index to Tabs
A.
Quality Working Group Proposal
B.
Letters from Interested Parties
C.
Reporting Standardized Quality Information
D.
Examples of Comparative Performance Reports
E.
Examples of Consumer Surveys
F.
Standards for Managed Care Organizations
G.
Quality Improvement
H.
Current Quality Activities
I.
Research/Technology Assessment
J.
Examples of Practice Guidelines
K.
List of Consultants
L.
Members of the Quality Work Group
�FOR OFFICIAL USE ONLY
I. BACKGROUND
CURRENT PROBLEMS
A.
Uncertainty pervades medical care.
In many areas of medicine, we simply don't know what works best.
[Tab I , Wennberg, 1990].
The scientific evidence for the effectiveness of many ~ perhaps
most ~ of the most common treatments is either mixed or
nonexistent.
This results in wide variations in professional opinions and in
medical practice. For instance, Bostonians receive almost
twice as much hospital care as New Haven residents, with no
discemable impact on their health.
This uncertainty can confound attempts to manage health care
competition and to control health care costs.
When we don't know what works best to treat a particular
illness, it's impossible to determine which provider treats that
illness best - to measure that provider's "quality of care."
A significant number of costly procedures have been found to
be either inappropriate or of uncertain value, in managed care
settings as well as in fee-for-service medicine. [Tab I ,
Bernstein et al, 1993; Leape et al, 1993; Hiboume et al, 1993].
�FOR OFFICIAL USE ONLY
Too little research is targeted toward reducing that uncertainty. [Tab
I, Wennberg, 1990]
Most efforts to evaluate new treatments do not test them in
realistic settings, or compare them to existing therapies.
Many medical interventions have not been assessed at all,
especially medical treatments that do not use new devices or
drugs.
Even well-documented research findings about appropriate treatments
and patterns of care frequently fail to reach practicing health care
providers or aid them in making clinical decisions. [Tab I , Kosecoff
et al, 1987]. This leads to:
Excessive use of unnecessary and inappropriate services.
Under use of needed and appropriate services, such as
preventive and prenatal care or follow-up visits for chronic
illnesses.
Unnecessary deaths, illness and disability that might have been
prevented with appropriate care. [Tab I , Healthy People 2000]
B.
A marketplace depends on broad availability of information to compare
products. That information has been lacking in health care. [Tab I , Office
of Technology Assessment, 1988].
Until recently, physician and hospital groups have opposed
publication of comparative information on prices and indicators of
quality.
�FOR OFFICIAL USE ONLY
Universal agreement on the best measures of quality has been
lacking.
Health care providers are frequently unaware of their own patterns of
practice, and how they compare to others'.
Consumers are often not informed about various treatment options
and their risks and benefits. [Tab I, Wennberg, 1990]
C.
Techniques used to improve quality have been ineffective. [Tab H, Institute
of Medicine (loM), 1990]
Most quality assurance activities undertaken by health care
institutions, groups or external reviewers do not prevent, identify or
correct quality problems
These methods focus excessively on processes of quality
assurance, such as quality committee meetings, case review or
incident reporting, rather than on achieving actual
improvement.
They focus on inspection of individual cases to detect unusual
events after-the-fact, and on identification of "bad apples"
among practitioners, rather than on identifying and correcting
the root causes of problems within an institution.
•
D.
Most quality assurance and improvement efforts have focused on
hospitals, rather than on the physicians' offices and clinics where
most care is delivered.
The current regulatory systems to assure quality are perceived as creating
more burden on providers than benefits to consumers.
�FOR OFFICIAL USE ONLY
Standards for health care facilities and HMOs include more proxies
for quality than measures of health care and patient outcomes.
Facility standards include hundreds of pages of detailed
requirements for nursing aide qualifications, square footage of
bedrooms, medical record-keeping and the like.
Standards for HMOs include requirements on enrollee
composition, and disenrollment on demand, which hinder
health plan operations.
Facilities and HMOs often undergo multiple surveys each year.
E.
Current protections for consumers vary by State, and they are inadequate to
counter the powerful incentives for underutilization of care that are built
into health reform.
Facilities and HMOs that opt not to participate in Federal programs
are subject to widely varying state licensure programs.
Other types of health plans, such as preferred provider organizations
and indemnity insurance, have been subject to virtually no regulation
intended to protect quality of care.
�FOR OFFICIAL USE ONLY
RECENT DEVELOPMENTS AND PROMISING SOLUTIONS
A.
Recently-developed tools can now support a new approach to assuring
quality of care. [Tab H, Jencks and Wilensky, 1992.]
Large health care data sets are becoming available for analysis, and
there are a number of efforts to develop data sets targeted
specifically for quality assessment. [Tab C: GHAA summary;
"Coalition Quality Initiatives"].
Powerful computing tools and techniques are enabling routine,
inexpensive analysis of these data sets.
Research using these data sets can assess the effectiveness of medical
treatments and reduce medical uncertainty.
Congress established the Agency for Health Care Policy and
Research (AHCPR) in 1989 to increase support for such
research.
The total Federal budget for such research has grown to $150
million in FY 1993.
A new effort to develop scientifically-based practice guidelines has
gathered steam.
AHCPR has developed 6 comprehensive guidelines on
treatment of important medical conditions. 4 more are due out
in FY 93, and 10 annually after that. [See samples in Tab J].
�FOR OFFICIAL USE ONLY
The American Medical Association and its associated specialty
societies are leading an effort that has developed hundreds of
guidelines, though these are of variable quality.
Due to these efforts, measurement of quality in an objective, sciencebased fashion is becoming feasible.
Techniques for measuring appropriateness of care and health
outcomes using data have been developed. [Tab E]
So have survey methods to assess consumer perceptions of
health status, health behavior and satisfaction; [Tab E, survey
instruments and reports]
Lists of quality measures have been compiled, and their ability
to distinguish true differences between providers assessed.
[Tab C: Siu 1991; HEDIS, 1993]
B.
This new, information-based approach is being piloted in a variety of
Federal-, state-, community- and industry-based programs around the
country. [See Tab D for examples.]
Business groups are now joining with providers and managed care
plans, both in localities and nationwide, to produce and publish
comparative quality information. Employers will use this information
to select providers and plans on the basis of both quality and cost.
Dozens of States, according to the National Association of Health
Data Organizations, have formed health data organizations that
publish comparative information on providers' on measures of quality
and cost.
�FOR OFFICIAL USE ONLY
A mass-market magazine providing consumers with helpful articles on
treatments and comparative information on physicians and providers
is currently being test-marketed in Wisconsin. [Health Pages]
C.
Programs have been established to help consumers sort through the new
wealth of information on health insurance, and to protect their interests in
other ways.
In 1990, Congress established programs to counsel Medicare
beneficiaries on the purchase of Medigap (Medicare
supplemental) insurance and long-term care insurance.
•
Under the Older Americans Act, since the late 1970's, each State has
a ombudsman's program for residents of long-term-care facilities.
1992 amendments to that Act will provide for a comprehensive
system of counseling and assistance for all forms of health insurance
for older Americans.
D.
Minimum standards for facilities and health plans are moving toward
assessment of actual performance rather than detailed structure and
process standards.
•
In 1987, Congress reformed Federal standards that nursing homes
must meet to participate in Medicare and Medicaid.
The new requirements are centered on improving the
functional status of nursing home residents.
Under the new regulations, according to the Health Care
Financing Administration (HCFA) use of physical and
chemical restraints in nursing homes has been cut nearly in
half, from 39% of residents in 1990 to 21% in 1992.
�FOR OFFICIAL USE ONLY
•
The Joint Commission on Accreditation of Health Care Organizations
(JCAHO) has been moving its accreditation for hospitals toward use
of specific quality indicators. [Tab B, JCAHO].
The National Committee for Quality Assurance (NCQA) new
accreditation standards for HMOs focus on quality measurement.
[Tab F, NCQA].
£.
Continuous quality improvement principles used in other industries are
beginning to be applied in health care. [Tab G].
These include efforts to collect data systematically, measure a broad
set of outcomes, identify areas for improvement, improve processes,
and regularly assess the effect of those changes on the outcomes
measures.
Successful examples of this approach include:
Latter Day Saints Hospital in Salt Lake City cut its rate of
deep postoperative infections in half, through studies of
surgical antibiotic use. [Tab G, Frontiers, 1991].
West Paces Ferry Hospital in Atlanta reduced its caesarian
section rate from 22% to 12% of births. [Tab G, Nelson,
1992]
The JCAHO and NCQA have implemented new standards that focus
on quality improvement. [Tab B, JCAHO; Tab F, NCQA].
�FOR OFFICIAL USE ONLY
II. Issues
A.
As incentives to control costs are put into place, the new system must
guarantee quality of care.
1.
The information on quality critical for choosing plans, practitioners,
providers and treatments is not yet available.
a.
Consumers
Need comprehensive, accurate and up-to-date
information to make informed decisions about health
care plans, select practitioners, and become more
active in making decisions about their own health care.
For this to happen, the new system must provide new
information and assistance in interpreting that
information, and must also assist consumers in
understanding and using the system itself.
b.
Practitioners
Need immediate access to valid information on what
works best in health care. The flood of information
from pharmaceutical company representatives,
professional organizations and the mass media is often
biased or incomplete, and is not easy to judge or use in
every day practice.
The new system must provide better and more
organized information on appropriate use of services.
The new system must reduce the burden of regulation
so that practitioners can focus on the delivery of care.
c.
Purchasers
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Need to have information that allows them to make
decisions based on quality as well as price. This
information must be comparable across plans.
2.
The new system must be designed to protect consumers from
substandard care.
a.
The system must be able to identify incompetent or impaired
providers, and either restore them to appropriate practice or
remove them.
b.
The system must assure that resource constraints do not
prevent consumers' access to needed services.
c.
The new system must foster an improvement in the average
level of care without imposing a specific approach from the
outside.
d.
The system must allow innovation in activities to improve
quality.
1.
2.
B.
It must not impose a surveillance system that
unnaturally diverts resources away from quality
improvement.
The "excellent" performers must be included in the
system to lead the way.
Without careful planning, collecting the range of quality of care information
needed for informed choice and accountability could become extremely
burdensome.
1.
The challenge is to identify measures that can be used today,
while research continues to develop better measures.
2.
Information on the health of the population and the
effectiveness of the system will require data from a variety of
sources.
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3.
C.
The need for information must not outstrip the availability of
measures nor burden the system with unreasonable data
collection.
The market cannot provide solutions to all quality issues.
1.
Regulation will be necessary to ensure a minimum level of
quality and efficient market function, particularly in areas
where competition is absent, and during the transition, when
the quality measurement and competitive forces will not be
fully in place.
2.
The current regulatory environment is not successful
a.
b.
3.
It involves over-regulation (overlapping Federal and
State mandates in areas of licensure and safety) and
micromanagement (telling labs and providers how to
run their quality management programs).
Producing the paperwork related to unnecessary
regulation diverts resources away from delivering care
and improving quality.
Standard reporting of performance should drive participants to
improve performance on the reported measures.
a.
b.
If quality measures are on target, we have valuable
information. If they are not, we fail to protect
consumers, assist practitioners and purchasers, and
assure accountability.
c.
D.
The new system can focus on measures that are
important for protecting quality and facilitating choice.
But any report will cover only a small fraction of plan
activities. Extrapolation about overall quality of care
must be done with caution.
GOALS FOR REFORM
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These recent developments provide a strong platform for health care reform to
meet its goals for quality:
•
To provide information to support consumer choice
•
To protect consumers
•
To improve the quality of care and services, and
•
To be accountable to policy makers and the public.
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HI. RECOMMENDATIONS AND RATIONALE
A.
SUMMARY OF WORKGROUP PROPOSAL
Recommendations:
The ultimate success of health care reform depends on the ability of the new system
to contain costs while protecting quality. The new system will:
Provide standardized reporting of information on quality.
Foster quality improvement by clinicians and institutions.
Ensure basic protections through Conditions of Participation.
Strengthen and streamline existing quality oversight mechanisms.
Bolster the knowledge infrastructure for quality care through evaluation
research, technology assessment, and patient care guidelines.
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B.
ORGANIZATION OF THE QUALITY MANAGEMENT SYSTEM
Recommendations:
The new system is decentralized and responsibility for quality is embedded at every
level and every organization.
Consumers will:
Be responsible for reporting information relevant to quality of care.
Use comparative information on plans, health care facilities,
practitioners and treatments to inform their decisionmaking.
Practitioners will:
Be held accountable for their comparative performance on quality
measures.
Work cooperatively with health plans to improve the quality of care.
Health care facilities will:
Be required to meet nationally uniform minimum, performance-based
standards.
Be held accountable for their performance on quality measures.
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Continually improve the quality of their care.
Use comparative information on plans, practitioners and treatments to
inform their decision-making.
•
Health plans will:
Protect consumers from poor quality by meeting Conditions of
Participation,
Measure and disclose their performance on quality measures
Disclose all material information, and
Report on, maintain and improve the care their providers and
practitioners deliver.
Health alliances and other purchasers will:
Protect consumers by using information on quality of care in selecting
and negotiating with plans.
Handle appeals of consumer grievances and requests to disenroll.
Collect and update enrollment data.
States will:
Monitor the quality of their State's health care system
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Prepare comparative
practitioners
Quality Reports on plans, providers and
Survey consumers
Establish health ombudsmen's offices
Transmit collected data and report state performance to the Federal
govemment
Provide technical assistance to providers, health plans, and practitioners
Assess health plan compliance with Conditions of Participation
Assess facility compliance with minimum licensure standards.
The National Quality Program (NQP) will:
Develop a core set of quality measures and consumer survey questions
Set goals for performance on those measures
Support research, technology assessments and pilot projects to undergird
quality measurement
Develop performance-based licensing standards for facilities
Set Conditions of Participation for health plans
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Set standards for, fund and monitor State performance
Evaluate the impact of health reform on quality regularly
The National Quality Advisory Council appointed by the President will:
Oversee the National Quality Program and its annual reports on
performance of the national and state programs.
Define the core set of measures annually and establish a five year
priority list for future measures to be included in the core set.
Review all state waivers and development of performance-based
licensing.
Rationale:
a.
Quality assurance and improvement requires commitment through out the
system. Poor quality usually results from failures in the system not
incompetent or uncaring individuals.
•
b.
Under reform State Health Alliances and health plans will be
accountable for the quality of care delivered to their respective
population.
Consumers must have the assurance that quality of care will not vary from
state to state, therefore, the workgroup recommends:
•
Standards for care and service set by the Federal govemment, and
Federal oversight of State performance in assessing compliance with
those standards.
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c.
Health plans and health alliances will have financial pressures that might lead
to quality problems, especially under service. Therefore, we recommend that
quality oversight be conducted, and Quality Reports be prepared, by an agency
independent of the plans and alliances ~ the State Quality Program.
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C.
STANDARDIZED REPORTING OF INFORMATION ON QUALITY
Recommendations:
The new health care marketplace will be driven by information. Our
recommendations ensure that a great deal of new, understandable, comparative
information will be available to facilitate choices of health plans, facilities,
practitioners and treatments, and monitor the performance of the system as a whole.
The National Quality Program will develop and pilot test a core set of
measures that apply to all plans, facilities and/or practitioners nationwide.
Measures will be developed that allow comparison of performance along four
aspects of quality:
Access to care
Appropriateness of care
Outcomes of care
Consumer satisfaction
States will publish QuaUty Reports that compare the performance of health
plans, facilities and practitioners along the national core set of measures, as
well as along measures of the state's choice. [See attached illustrative quality
report]
State health ombudsmen will assist consumers in interpreting this information.
20
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The National Quality Program will publish a national report to compare State
performance along quality measures.
Plans will be held legally accountable for the accuracy of their data. States will
conduct some audits to verify data accuracy.
In selecting measures, the NQP will adhere to high scientific standard, while
minimizing collection burden:
The set of measures will be representative of the range of services
provided by the entity in question,
Pilot testing shows them to be reliable and valid
Pilot testing shows performance on the measures to vary widely.
The data needed are obtainable without significant burden,
Measures will change over a period of years in order to cover a wide range of
quality issues, reflect medical progress and assure that measures remain
representative of plan performance
Measures have already been developed that can serve as a starting point. They
will be refined over time by the National Quality Program.
Rationale:
a.
The cornerstone of health care reform is informed decisionmaking. (Tab C,
OTA, 1988; Tab I , Wennberg, 1990)
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The current availability of information to facilitate choice and protect quality
is limited.
The customers for this information have little experience using what is
available.
•
b.
Plans and providers need accurate data on their performance to gauge their
quality of care, identify areas for improvement and measure their progress.
(Tab C, Siu, et. al., 1991)
The quality measures must meet the highest standards and change frequently.
•
•
c.
•
If the measures are on target, we have valuable information. If they are
not, we fail to protect consumers, assist practitioners and purchasers, and
assure accountability.
Plans will divert resources to improving performance on these measures. If
the measures are static gaming will occur.
If the measures are too burdensome to collect, the system will fail.
22
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D.
QUALITY IMPROVEMENT
Recommendations:
Health care reform will foster effective and efficient internal quality assurance
and quality improvement efTorts by all health plans and facilities in the system.
These programs will:
Address problems of overuse, under use and poor technical and
interpersonal performance
Endeavor to identify and correct problems involving all settings, types
of clinicians and patients within the plans
Strive to eliminate poor care, enhance the average level of quality over
time and identify superior performance, and
Be accountable by documenting and reporting measurable improvement
in quaUty.
To facilitate these efforts, States will arrange for voluntary technical assistance
programs funded by Federal grants which may include:
Fostering collaboration among plans, providers, and consumers to deal
with common problems and share information on improvement
Formation of clearinghouses that maintain information on successful
improvement projects, quality measures, practice guidelines, and
research findings
Feedback of data on performance, particularly by means of
computerized guidelines and expert systems
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Medical record audits to help providers understand problems
Advice on clinical or management strategies that have proven effective in
improving performance, and
Other approaches developed locally or statewide.
Rationale:
a.
Quality improvement is most likely to be achieved when it is internally motivated.
The workgroup believes protecting quality will be accomplished most expeditiously
by providing quality improvement tools, not rules. (See Tab G, Berwick, 1989)
•
b.
External incentives to improve quality will expedite the transition to a quality
system that is internally motivated. Holding plans accountable for the results of
the care delivered and for achieving quality improvement are appropriate
external incentives.
•
c.
Specific structures
and procedures for quality assurance and
improvement are not specified.
This condition requires plans to demonstrate continuous improvement in the
quality of care through results such as improved health outcomes and
increased patient satisfaction.
Solid, meaningful quality improvement (QI) efforts are taking hold across the
country. (Tab G, Frontiers, 1991)
•
•
d.
Many established health care organizations and institutions are implementing
performance based quality improvement programs.
These recommendations assist their efforts by removing some of the
administrative and regulatory barriers to these plans.
Not all health plans are so far along. Most plans will require assistance to
mount credible internal QA/QI efforts.
24
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E.
CONDITIONS OF PARTICIPATION
Health plans must meet the following nationally uniform Conditions of Participation
in order to participate in health care reform:
1.
Fiscal soundness
2.
Truth-in-marketing
3.
Credentialing of practitioners and facilities.
Every 2 years, plans
must:
Check providers against national databases.
Consider credible complaints against the providers.
Drop providers that consistently fail to meet quality standards or
are responsible for fraud or mismanagement.
4.
Enrollee Rights and Responsibilities. A plan must:
Disclose to consumers all material information regarding the plan
and their rights and responsibilities within it.
Provide due process for enrollees to appeal denial, termination
or reduction of coverage.
Allow state health ombudsmen to assist consumers in their
appeals.
Allow unresolved complaints to be appealed to the Health
Alliance then the State.
5.
Confidentiality.
6.
Complaints.
A plan must investigate and attempt to resolve complaints.
7.
Disenrollment for Cause.
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Enrollees must be permitted to disenroll at any time for good
cause.
State health ombudsmen may assist consumers in this process.
The purchaser is responsible for ensuring there is no gap in
coverage.
8.
Utilization Management. A plan must disclose all its protocols for
controlling utilization and costs, including:
Methods used to manage the network of providers, such as the
selection criteria and internal performance standards.
Compensation methods for providers, such as capitation;
Incentives to providers to control utilization;
Utilization review criteria - criteria by which health care services
are determined to be inappropriate; and
Protocols for managing the care of high-cost patients.
9.
Internal Quality Management. A plan will be held accountable for
measurably improving the quality of its care and service, and for
correcting problems.
10.
Data Management and Reporting. A plan must maintain the data
required to determine measures for the quality report and must report
applicable data to the State.
Rationale;
a.
Under health care reform, health plans will be accountable for providing all
necessary health care to their enrollee populations. Therefore, they must be
held accountable for meeting quality goals relating to consumer protection,
consumer information to support choice, and quality improvement.
b.
Consumers' trust in the new health care system must be built. Consumer groups
advocate strong protections that assure the system meets minimum standards.
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c.
Certain kinds of information is particularly reassuring to consumers. For
example:
•
•
Plan utilization management strategies that might limit access to care.
•
d.
Information on providers and treatments
Information on the standards to which the plan holds practitioners
Consumer groups (See Tab B, Consumer Coalition) advised that consumers
must be able to protect themselves through:
Grievance procedures
Appeals of unresolved grievances
If all else fails, disenrollment.
e.
In order to assure consumers an acceptable level of protection, national
standards must encompass and move beyond the various consumer protection
and quality assurance standards in place for managed care organizations today.
(Tab F)
f.
Plans that fail to meet these standards should not be permitted to provide
coverage under health reform. Therefore the standards must be conditions of
participation.
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F.
STRENGTHENING AND
ASSURANCE ACTIVITIES
STREAMLINING
CURRENT
QUALITY
The Health Care Financing Administration (HCFA) now conducts three quality
assurance programs that provide basic consumer protections. However, all three of
these programs have been criticized as placing undue burden on providers and
practitioners.
Health care reform will build on these three programs to achieve the quality goals of
consumer protection, quality improvement and accountability. Each program will be
significantly strengthened and streamlined.
These programs are:
1.
Minimum Standards forHealth Care Facilities. The floor for health care
quality in the United States is established in licensure and certification
standards set by the State and Federal governments. (Tab H, loM, 1990)
•
These standards will be revised to be more effective and based on
performance.
The 1987 Nursing Home Reform requirements are performance
based and will be retained as is. (Tab B, National Citizen's
Coalition)
•
Current standards will be retained until new ones have been fully
promulgated, pilot-tested, evaluated and implemented.
•
The process for assessing compliance will be revised to reduce the
burden on facilities.
Multiple inspections by govemment agencies will be eliminated.
2.
Medicare Peer Review Organizations (PROs). The PRO program, the primary
Federal effort to monitor the quality of health care provided to Medicare
patients, will be retained.
•
This program is already engaged in an effort to make itself more
efficient, effective and accountable; this new effort is highly compatible
with health care reform. (Tab H, Jencks and Wilensky, 1992)
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•
•
3.
PROs will pilot test the quality management techniques proposed under
reform.
The program's effectiveness will be regularly evaluated.
The Clinical Laboratory Improvement Amendments of 1988 (CLIA). Under
CLIA, all labs in the U.S. are regulated. (Tab H, CRS) The burden and cost
of this program will be significantly reduced.
•
Labs performing only waived tests will no longer pay fees and file
registration forms.
•
Maintain regulatory scrutiny of labs that ~
Conduct a comprehensive menu of tests
Conduct a large volume of tests
Engage in cytology tests such as Pap smears
Conduct tests to monitor care while it is being delivered, such as
dialysis labs.
Simplify standards to focus on quality control procedures, test accuracy
and specimen handling.
Immediately eliminate the requirement
proficiency testing.
that all labs engage in
As of the second year of reform, eliminate regulation of any other types
of labs for which experience shows regulation to be unnecessary.
Rationale:
a.
It is critical to maintain a floor for health care quality, below which no health
care provider is permitted to fall. This floor is set by licensure and
certification for most facilities, by CLIA for labs, and is monitored for
Medicare beneficiaries by the PROs.
b.
The current regulatory system has improved health care delivery in some areas.
And there have been some notable successes in improving quality of care, for
instance:
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•
•
c.
Nursing home use of restraints were cut nearly in half between 1990 and
1992 as a result of nursing home reform (HCFA, unpublished data);
Facilities for the mentally retarded were transformed from human
warehouses to providers of active treatment to all residents as a result
of new standards in the 1970s;
Many believe such examples are exceptions rather than the rule, and that the
quality of care overall has not improved as a result of existing standards. (Tab
H, loM, 1990) Problems include:
•
•
The regulations are criticized by consumers and providers as being
ineffective, burdensome, costly and inconsistently enforced.
•
Providers say the cost and burden of compliance stifle creative efforts
to improve quality.
•
d.
The standards often focus on the process of providing care not on
patient outcomes.
PROs have focused on small problems and single cases rather than the
big picture.
Consumer groups and experts advise:
•
Maintaining consumer protections are not removed unless they have
been demonstrated to be inefTective or have been replaced by a program
that is demonstrably more effective.
•
Using standards based on performance.
•
Making the quality assurance system for health care facilities more
efficient to reduce the burden on practitioners and facilities is reduced.
•
Providing facilities are provided incentives to internally, continuously
and measurably improve the quality of their care.
30
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G.
GUIDELINE DEVELOPMENT, TECHNOLOGY ASSESSMENT AND
CLOSELY RELATED RESEARCH
Recommendations; The Federal Govemment will •
Annually list priorities for measuring and assessing the quality of care, over the
next 5 years.
•
Set research priorities will include:
The greatest medical uncertainty in treatment,
the greatest variation in practice patterns,
Significant cost to the health care system, and/or
Significant burden to the population;
•
Support research on methods central to quality improvement.
•
Support health care evaluation research (including medical
effectiveness research, clinical trials of therapies, and other projects).
•
Funding for such projects is recommended to be increased.
•
Establish non-binding, science-based standards for clinical practice guidelines
and procedures for evaluating guidelines according to those standards, and
evaluate any guidelines voluntarily submitted for review.
•
Establish non-binding, science-based standards for and develop procedures for
evaluating the clinical appropriateness of utilization management protocols.
Rationale:
a.
Most of the variation in practice patters is due to uncertainty about diagnostic
indications or effectiveness of particular treatments. Research is needed to
reduce this uncertainty and to systematically improve health care in America.
b.
Better information on appropriate practice as well as effective treatments and
technologies will support consumer choice and lead to quality improvement.
31
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c.
The success of our efforts to assess and improve quality will depend on the
quality of the tools we use.
d.
Setting priorities for research, unlike the current, largely ad hoc process for
approving research proposals, will ensure that m^jor areas of medical
uncertainty that have a great impact on Americans' health will be addressed.
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IV. Questions and Answers
TYPICAL QUESTIONS THAT COULD BE RAISED BY CONSUMERS,
PRACTITIONERS, PLANS, PROVIDERS AND PURCHASERS
Reporting Standardized Quality Data
1.
How can we be sure that the Report on Quality Measures won't be too
burdensome and that important aspects of quality are measured?
a.
The battery of measures will be selected by the National Advisory Committee.
The membership will be balanced to include:
purchasers who will favor more information
plans who will be particularly concerned about the burdens of
data collection
providers who may be most sensitive to the technical aspects of
care
patients who may be more concerned about the interpersonal
aspects of care, and
quality measurement experts who may be more sensitive to
methodologic issues in measurement.
b.
We expect that the expertise on the committee and the balance in membership
will help optimize the selection of measures in the battery.
2.
Won't providers see the report on quality of care as punitive?
a.
Several aspects of the program will reduce this possibility.
•
Quality improvement will be adopted as a condition of participation.
Measurement is the first step in this process and providers will be
involved in the measurement.
33
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Technical assistance will be offered to plans who wish to improve
performance by a nonregulatory agency. This will send a clear message
about the non punitive intent.
Quality measurement will be done by the plans themselves. This will
convey the message that they are part of process, not just the object of
it.
3.
The limited number of measures in the report will make it difficult for
consumers to make an informed choice. This is especially true if the measures
are uncorrelated and present a confusing picture.
a.
It is true that only a portion of the types of care delivered will be measured
and that performance of plans may differ across measures so we need to be
modest in our claims.
b.
Although measurement may be inadequate to make fine distinctions, it still may
be sufficient to identify plans that are delivering truly superior care or very
inferior care.
•
c.
We envision that the use of the quality information may be similar to
that used by Consumer Reports. Products are rated numerically, but
users are advised that small differences in ratings are not meaningful.
Only products which stand out are grouped separately.
Even if measurement
valuable.
doesn't provide tremendous aid for choice, it is still
•
•
d.
Trends will tell us whether we are improving care over time.
Plans that leam the methodology of measurement can use this skill in
improvement activities.
A national measurement system will send a strong message about the
importance of measurement and its role in quality improvement.
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4.
How will public health reporting fit in and how will public health concerns be
balanced?
a.
Public health reporting will continue. Public health trends will provide insight
into things we should measure as part of the quality report.
•
b.
For example if the incidence of active tuberculosis increases, quality
measures might be developed to assess whether plans' testing
procedures and prophylactic treatment is appropriate.
Public health concerns will drive the initial selection of measures and the
development of new measures.
•
The Advisory Committee will have among its principal goals the
reduction of the illness burden in the country.
•
Conditions which have an important impact on the health of a large
number of persons will be preferentially chosen.
QuaUty Improvement
5.
Do we really need a state-run technical assistance program, won't it be too
bureaucratic?
a.
These activities are very important because they send a message that quality
improvement is vital.
b.
The state will merely oversee these activities. We expect technical assistance
to be carried out by a variety of different organizations including private sector
consulting firms, foundation inspired public-private partnerships, consortia of
academic medical centers, innovative state agencies etc.
c.
The large number and diversity of organizations involved will foster innovation
and increased understanding about the effectiveness of different approaches to
quality improvement.
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6.
Don't you think that requiring plans and facilities to meet aU these
prescriptive conditions will stifle innovation, and conflict with the goal of
continuous quality improvement quality under health care reform?
a.
These goals should not conflict. Unlike some past and current standards for
facilities and health plans,
•
the standards imposed under the mature reformed health care system
will be based on actual performance,
•
rather than on restrictive detailed mandates about structures and
processes ~ such as staffing levels, enrollee composition and quality
assurance committees.
b.
The quality management proposal also provides incentives and technical
assistance for plans and facilities to improve the quality of their care.
7.
Doesn't the emphasis on continuous quality improvement activities develop
voluntarily within health plans, place undue reliance on the good will of health
plans and provide inadequate consumer protection?
a.
Many studies show that meaningful improvement occurs when health care
providers are involved in and committed to a process of improvement that is
relevant to their own patients and experiences. This is difficult to legislate or
impose from the outside. We will require disclosure of the results of quality
improvement, however, so this is not an entirely voluntary process.
b.
Furthermore, this is not the only mechanism for quality measurement and
assurance under health care reform. We have included additional provisions,
such as conditions of participation, the requirement for ombudsmen, and the
gathering and publishing of standardized quality measures, that will provide
adequate consumer protection.
8.
Are the States capable of mounting the type of technical assistance
contemplated in this proposal?
a.
Some States we will be able to because they have more experience and existing
resources to draw upon than others. However, the States have the option of
contracting with private sector groups to provide the necessary expertise.
36
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b.
In addition, technical assistance from the Federal level will also be available.
One important role of the Federal govemment will be to gather "lessons
learned" from quality improvement initiatives and disseminate that information
to interested organizations.
9.
Is there any evidence that internal quality improvement efforts in health care
settings are actually effective?
a.
Yes. For example as a result of one hospital's dedication to quality
improvement (See Tab G, Nelson 1992):
•
C-section rates were cut from 22 percent to under
12 percent in three years;
•
the efficiency of treating patients with chest pain improved so that the
percentage of patients admitted who actually had a heart attack vs. those
patients who did not have heart attack related pain increased from 28
percent to 68 percent. This led to savings to one customer of $330,000
in one year;
•
the percentage of non-RN duties that RNs perform was reduced from
40 percent to 24 percent, saving $250,000 annually;
•
Annual operating margin increased from $9 to $20 million.
10.
Is the supply of persons skilled in QA/QI approaches and methods sufficient
for the program you propose?
a.
We believe that the current supply of persons, combined with technical
assistance, is adequate to begin.
b.
However, we need more health professionals trained in epidemiology and
statistical analyses, as well as group processes and the identification of
meaningful hypotheses for quality improvement. Fortunately, there already
exist some relevant training opportunities and professional groups.
11.
Haven't past attempts at quality improvement been largely ineffective?
37
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a.
I don't think one can generalize from experiences 15-20 years ago to the
present for several reasons.
Earlier efforts have been more externally imposed and not focused on
results and quality improvement.
We have better measures and information systems today than we did
h
the past, and a large cadre of health professionals skilled in quality measurement.
b.
The competitive health care system we envisage emphasizes competition based
on value, quality, and cost.
•
It contains mechanisms to hold plans accountable for good health care
outcomes and has better information about medical effectiveness than
previously existed.
Consumer Protection through Conditions of Participation
12.
How can I be sure that restrictions on my right to choose doctors and hospitals
won't harm the quality of my care?
a.
Health plans will be required to ensure that the doctors, hospitals and other
health care providers they use have been licensed or certified as meeting basic
State and Federal standards for the quality of care.
b.
They will be required to reverify these credentials at least every two years, and
to check any disciplinary actions, malpractice history and credible complaints
each time.
13.
a.
What if the health plan I choose makes me wait a long time for an appointment
or necessary treatment, even when I am sick?
You can file a complaint with the plan, which will be required to investigate
and resolve the complaint with the speed appropriate to the urgency of your
medical situation. The State ombudsman's office can help you investigate and
resolve the complaint.
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b.
If the plan does not resolve the complaint to your satisfaction, you can appeal
to your health alliance or employer, which must attempt to resolve the issue.
•
If all attempts to fix the situation fail, you can ask the health alliance to
let you disenroll immediately "forcause."
•
The health alliance is required to enroll you in another plan of your
choice and to ensure there is no gap in coverage.
14.
Setting truth-in-marketing standards is not enough to protect consumers.
Fraudulent information and deceptive marketing are likely to be rampant.
Why haven't you simply banned plans from giving out any information that
hasn't been approved by the State?
a.
Competitive markets work best when consumers have a wide variety of
information on which to base their choices.
•
Rather than banning disclosures, the health reform plan will regulate
them according to the a model similar to that the Securities and
Exchange Commission model uses for corporate stock offerings.
•
Under this model, plans will be held legally responsible for fully and
accurately disclosing all information about the plan to consumers. Plans
that do not meet this requirement will be held liable for that failure.
15.
Why haven't you placed restrictions on the type of utilization review criteria
plans can use?
a.
A key tenet of quality management under health care reform is that standards
of care be scientifically based. However, requiring a "Good Housekeeping Seal
of Approval" for every single review criterion would be unduly burdensome,
both for health plans and the govemment, and would create unacceptable
administrative costs.
b.
Instead, plans will be required to disclose their utilization management
protocols. The Federal govemment will also carry out a program to develop
science-based standards and procedures for evaluating the clinical
39
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appropriateness of utilization management protocols and of the methods for
applying them.
c.
Purchasers, and consumer groups will then be able to use the standards and
procedures in evaluating use of a particular protocol.
16.
Strategies to control utilization are the chief mechanism that a plan has to
compete in the reformed health care system. Requiring disclosure of these
strategies essentially requires them to share trade secrets with competitors.
How can you justify this requirement under managed competition?
a.
Utilization management protocols are "rules" by which care delivery
determinations are made. Consumers, practitioners and purchasers should be
informed of the rules of the care delivery system.
b.
These protocols have the potential to become powerful incentives for
inappropriate underutilization of care. It is important for consumers and
purchasers to have this information when they are choosing plans on the basis
of quality.
c.
Plans will compete on which of the publicly-available utilization management
methods they use, and on how well they apply them.
Strengthening Existing QA Structures
17.
What will the role of voluntary accreditation organizations be in this new
system?
a.
Participation in the voluntary accreditation process will be encouraged under
health care reform for both health plans and facilities.
b.
The Federal govemment will have authority to determine that the accreditation
standards and processes used by a voluntary organization would provide
reasonable assurance that the Conditions of Participation for health plans or
the certification standards for a type of facility are met.
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c.
The requirement for Federal certification of plans accredited by approved
organizations, and the requirement for Federal certification and State licensure
of facilities accredited by approved organizations, would be waived.
18.
My mother needs to find a nursing home. How will health care reform protect
her?
a.
Under health reform the requirements for nursing homes that participate in
Medicare and Medicaid will apply to all nursing homes in the country.
•
These standards were enacted under a 1987 Nursing Home Reform
Law. Since implementation began in 1990, quality in nursing homes has
measurably improved.
•
For instance, the number of nursing home residents who are restrained
physically or chemically has been cut nearly in half.
b.
Under health reform, States will provide technical assistance to nursing homes
and other health care facilities to help them meet the Federal standards and
improve the quality of their care.
19.
How can you ensure that consumers will be protected by national standards
under a system of State flexibility?
a.
The same quality standards and quality measurement system will apply to
health care in all States, whether or not they receive waivers from some other
requirements contained in health care reform. In addition, the Federal
govemment will exercise general oversight over state quality assurance
activities.
b.
With respect to standards for health care facilities the Federal govemment will
assess whether each State's standards are substantially equivalent to the
strengthened essential Federal standards.
41
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c.
If and only if they are substantially equivalent - a criterion that will be strictly
applied ~ will that State be exempted from the requirement for Federal
certification of facilities within its borders.
42
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V. POLITICALCONSIDERATIONS
A.
PROVIDER GROUPS (See Tab B for materials on groups)
1.
We met with the American Medical Association (AMA), and received a
number of policy papers from them.
2.
The AMA is likely to support the following aspects of our proposal,
according to AMA policy papers:
•
•
Reducing the burden on physicians
Review Organization program.
•
3.
Disclosure of utilization review criteria.
Reducing the burden on physicians from the Clinical Laboratory
Improvement Amendments of 1988.
The AMA is likely to offer qualified support for public release of
physician-specific quality measures. The AMA has said it is not opposed
to such release, as long as:
•
•
•
4.
from the Medicare Peer
The data are primarily used for education of consumers and providers;
Physician groups and individual physicians have the opportunity to
review and comment on data releases prior to the release;
All data released is severity-adjusted and collected from carefullyselected studies where it may be deemed accurate, reliable, and
meaningful to physicians, consumers and purchasers.
The AMA would support the following additional proposal related to the
quality working group's efforts:
•
Creation of a national commission to review the multiple regulatory
burdens on the health care system and physicians and recommend
elimination of unnecessary, ineffective and overly costly rules and the
coordination of other regulatory efforts.
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5.
The AMA is likely to oppose the following recommendation,
past actions:
•
based on its
Creation and operation by the govemment of the national
credentialing databases recommended
for use as part of the
Conditions of Participation for health plans. The AMAoperates its own
database containing credentialing information.
44
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B.
CONSUMER GROUPS
1.
We have met with the following consumer groups , who are members of
the Coalition oh Consumer Protection and Quality in Health Care Reform:
American Association of Retired Persons (AARP),
Families USA
Gerontological Society of America
Medicare Advocacy Project
National Committee to Preserve Social Security and Medicare
National Council on the Aging
National Senior Citizens Law Center
National Citizens Coalition for Nursing Home Reform
And with the following other consumer groups:
•
Consumers Union
National Association of Protection and Advocacy Systems
We have also received position papers from the Coalition and some of its
member groups and from the Working Group on Managed Competition,
which includes some consumer groups and consists of advocates of a
single-payer system.
2.
Consumer groups supported these aspects of our proposal:
•
Universal, nationwide application of the uniform quality standards
and methods of assuring quality.
•
Publication of comparative quality information on plans, facilities,
practitioners and treatments.
•
A quality oversight organization that:
Is independent.
Reviews patterns of care
Conducts a consumer survey.
•
A set of minimum standards for health plans , including:
Requirements for broad disclosure of information
A process for appealing decisions to deny or terminate
treatment.
A formal grievance process
Disclosure of utilization management protocols
45
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•
•
3.
An ombudsman program.
Retention of the PRO program.
Individual consumer groups also supported the following aspects of our
proposal:
•
•
4.
AARP supports a continuous quality improvement approach to quality
assurance, as long as that approach is backed-up with enforcement
authority.
The National Citizens Coalition supported retention in full of the
1987 Nursing Home Reform Law.
Consumer groups favored the following other proposals:
•
•
Governmental. authority to act promptly in response to poor quality of
care with a full range of sanctions. [These issues were considered by
a working group on enforcement.]
•
5.
Routine review of individual cases of care by the external quality
oversight agency.
Either heavy representation of consumers on a health plan board, or
a separate consumer board to review utilization management
decisions.
Consumer groups are likely to be concerned about:
•
Our recommendation to change certification standards for health
care facilities other than nursing homes and to provide incentives for
states to revise their licensure standards.
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C.
MANAGED CARE INDUSTRY AND COLLABORATING BUSINESS
GROUPS
1.
We met with:
•
•
•
•
Managed Health Care Association
Aetna Health Plans
Prudential Insurance
Xerox Corp.
We received position documents and other information from some of these
and from:
•
•
•
A group of 30 major managed health care plans, managed care
organizations, businesses and consumer groups.
American Managed Care and Review Association (AMCRA)
Harvard Community Health Plan
2.
In various communities and nationwide, the managed care industry has
joined with groups of medium-to-large corporations in coalitions to develop
database and quality measure and provide comparative quality information
to purchasers.
3.
The managed care industry and its collaborating businesses
supports our recommendation for:
•
strongly
A system of comparative quality information, including a common
set of performance measures, and a "report card" that would provide
comparable information on quality.
Note: These groups are working to develop their own quality
measures and report cards, which they hope will be nationally
adopted.
4.
Managed care-business
•
coalitions are likely to support:
A set of minimum standards for health plans, compliance with which
may be assessed by private, voluntary accreditation organizations.
These groups have been working closely with the National Committee for
Quality Assurance, which was formed by the managed care industry and
accredits HMOs.
5.
AMCRA opposes , and much of the health insurance and managed care
industry can also be expected to oppose, our recommendation for:
47
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•
Public disclosure of utilization management protocols, including
utilization review criteria.
48
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D.
ACCREDITATION GROUPS
1.
We met with the following groups that set standards for segments of the
health care industry and assess compliance with those standards.
•
Joint Commission on Accreditation of Healthcare Organizations
(JCAHO), which accredits hospitals, home health agencies, and other
facilities.
•
National Committee for Quality Assurance (NCQA) which accredits
HMOs.
We also received
organizations:
information from the following other accreditation
•
•
2.
American Accreditation Program Inc., which accredits preferred
provider organizations (PPOs)
The Community Health Accreditation Program
accredits home health agencies.
Accreditation groups will support our recommendations
(CHAP), which
to:
•
•
3.
Set minimum standards for licensure and certification of facilities and
Conditions of Participation for health plans, and
Allow facilities and health plans to demonstrate that they meet
those standards through accreditation by approved private groups.
JCAHO, NCQA and CHAP support our recommendations
•
Development of systems for quality measurement
•
Dissemination of comparative
measures.
•
A strong focus on quality improvement.
for:
49
quality information based on the
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E.
QUALITY EXPERTS
1.
Wc met with the following individuals, each of whom has considerable expertise
on health care quality issues:
Don Berwick, Institute for Healthcare Improvement
David Blumenthal, Massachusetts General Hospital
R. Heather Palmer, Harvard School of Public Health
Ernest Sessa, Pennsylvania Health Care Cost Commission
John Ware, New England Medical Center
Mark Chassin, New York State Health Commissioner
Brent James, Intermountain Health Care, Utah
Susan Horn, Intermountain Health Care, Utah
We also had contact with a large number of other experts on quality either by
telephone or through the audits process.
2.
In general, the quality experts supported our recommendations for:
•
A focus on quality improvement, including:
Provision of technical assistance to plans, providers and
practitioners.
Separating technical assistance from regulation.
Giving State technical assistance programs flexibility.
Requiring plans to demonstrate quality improvement
Focusing consumer protection efforts on vulnerable populations, especially
during the transition
Developing valid measures of various aspects of quality, and feeding their
performance on these measures back to plans and providers.
Uniform national standards for plans and facilities, that are based on
performance.
Disclosure of utilization review criteria.
Targeted effectiveness research and technology assessment.
3.
Some of the quality experts were concerned about our recommendation for:
•
Publishing a "report card" containing comparative quality information
public, on the grounds that this could be viewed as punitive and could
50
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interfere with plans' and providers' cooperative, internal efforts toward
quality improvement.
Other quality experts strongly supported this recommendation.
4.
Various quality experts made the following additional suggestions:
•
That the health care improvement goals of the quality program be
clearly stated, and that reduction in the Nation's burden of illness be
a central goal.
•
That competing plans and providers need to work together for quality
improvement, and that antitrust laws and other barriers to this
collaboration should be removed.
•
Creation of a national quality commission akin to the Physician
Payment Review Commission
•
Presentation of awards to plans and providers that achieve quality
improvement or participate in quality improvement efforts.
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F.
CONGRESSIONAL CONCERNS
1.
Few Congressional health reform bills have addressed quality issues in
a comprehensive manner.
•
2.
Members of Congress
recommendations:
•
3.
The Cooper billH.R. 102nd Congress, adopted the recommendations
of the Jackson Hole Group for publication of comparative quality
measures to support purchaser and consumer choice.
are
likely
to
support
the
following
Sen. David Durenberger, R-Minn., supports a "report card" to make
the health care system accountable for its performance and to support
consumer choice. [See United HealthCare report card press release]
Some members of Congress are likely to be concerned
proposals to modify current Federal quality activities.
about our
•
House Energy and Commerce Committee Chairman John Dingell, DMich., and other Congressional sponsors of the 1988 Clinical
Laboratory Improvement Amendments (CLIA)legislation, are likelyto
strongly oppose any changes to that law.
•
A number of members of Congress, including Senators Jay
Rockefeller , D-W.Va. and David Durenberger , R-Minn., have
expressed concern — though not necessarily opposition — to
Medicare's new direction for the PRO program ,and believe it is being
implemented too fast.
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G.
MEDICARE PEER REVIEW ORGANIZATIONS
1.
We received position papers from representatives
Organizations (PROs), including:
•
•
of Medicare Peer Review
American Medical Peer Review Association
Michigan Peer Review Organization
2.
These papers essentially called for the expansion of the PRO program to
be the quality assurance mechanism for the entire health care system.
3.
PROs are not likelyto favor the quality working group's position, which is that
PROs are free to compete to contract with States to carry out all or part of
State quality programs.
4.
The PROs are likely to oppose the quality working group's
recommendations to amend the PRO legislation to be more consistent
with health care reform, and with Medicare's new direction for the PRO
program.
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VI.
Appendix
54
�HYPOTHETICAL STATE
1996 HEALTH PLAN QUALITY REPORT
DEFINITIONS OF MEASURES
QUALITY MEASURE
DEFINITION
:i;;Acqiss:^;!CARE::::l
Time to obtain initial visit with primary care doctor
j For new enrollees, the average number of days between the time they scheduled their first
j appointment for non-emergency care, and the appointment date.
Percent of enrollees who have never seen a plan provider
J Pet of enrollees whose files register no encounter since the date of enrollment.
Percent of patients with asthma seeing allergists.
1 Pet. of patients with diagnosis of asthma who had one or more consultations with an allergist
| during 1996.
Percent of pregnant women receiving early prenatal care
I Pet. of women diagnosed as more than 3 months pregnant at any time during 1996 with one
| or more prenatal care visits during the first 3 months of pregnancy.
Rate of complete immunization (children age 2-5)
| Pet. of children bom between 1/1/92 and 12/31/94 who have been fully immunized according
! to the recommendations of the Centers for Disease Control and Prevention and the American
! Academy of Pediatrics.
Annual mammography rate for women aged 51 to 75
; Pet. of women bom between 1/1/20 and 1/1/45 who had a mammogram in 1995 or 1996.
Percent of diabetics receiving blood tests to assess
diabetes control
! Pet. of patients diagnosed with diabetes before 1/1/96 who had two or more blood tests for
! hemoglobin A1C during 1996.
Death rate after a heart attack
; Risk-adjusted mortality rate for hospitalized heart attack patients, within 30 days of admission.
Low birthweight babies (percent of all births)
! Percent of all babies born during 1996 weighing less than 2,500 grams, adjusted for the risk
! status of the mother.
Percent of nursing home patients with bedsores
J Risk-adjusted percent of nursing home residents with one or more facility-acquired bedsores.
|
Percent of enrollees satisfied with the plan
; Pet of those surveyed saying they were "satisfied" or "very satisfied" with the plan
|
Percent of enrollees satisfied with primary care physician
! Pet of those surveyed saying they were "satisfied" or "very satisfied" with the doctor who serves
| as their primary source of medical care.
Percent of enrollees leaving the plan (1996 to 1997)
I Pet of those enrollees who neither moved nor changed purchasers who disenrolled from the
! health plan between 1/1/96 and 1/1/97.
Percent of enrollees using out-of-plan services (where
applicablr'^^^
! For plans which have restricted networks or panels of providers, the percent of e n r r " - | s
! having one or ' ^ ^ ^ n c o u n t e r with an out-of-plan provider in 1996.
|
ivCON^ujifl^SATISFACtlO^
w
�Index to Tabs
A.
Quality Working Group Proposal
B.
Letters from Interested Parties
C.
Reporting Standardized Quality Information
D.
Examples of Comparative Performance Reports
E.
Examples of Consumer Surveys
F.
Standards for Managed Care Organizations
G.
Quality Improvement
H.
Current Quality Activities
I.
Research/Technology Assessment
J.
Examples of Practice Guidelines
K.
List of Consultants
L.
Members of the Quality Work Group
�Clinton Presidential Records
Digital Records Marker
This is not a presidential record. This is used as an administrative
marker by the William J. Clinton Presidential Library Staff.
This marker identifies the place of a tabbed divider. Given our
digitization capabilities, we are sometimes unable to adequately
scan such dividers. The title from the original document is
indicated below.
Divider Title:
�Tab A
Quality Working Group Proposal
�A p r i l 23, 1993
FOR OFFICIAL USE ONLY
page 1
PROPOSED QUALITY MANAGEMENT SYSTEM FOR
HEALTH CARE REFORM
A. Overview. Health Care Reform can transform the assurance of health care
quality. The cunent system uses retrospective review to measure compliance with State,
Federal, and private sector rules and with poorly-defined clinical standards, and it
provides little information to consumers and purchasers. The proposed system will apply
to the entire country and to all payers and will
o
give consumers and purchasers information on quality to help them make
better choices among health plans, facilities, and individual practitioners,
o
empower institutions and front-line physicians with information and
technical assistance that helps them provide better care,
o
set essential performance standards for health plans and institutional
providers,
o
give Congress and the public information to assess the success of health
care reform in supporting quality care, and
o
strengthen the knowledge infrastructure for quality care through evaluation
research, technology assessment, and patient care guidelines.
Over the next decade, the system's ability improve quality through information feedback
and consumer demands will increase dramatically as information systems and new
knowledge enhance our ability to apply science to improving and measuring quality.
B. Organization. The proposed system is decentralized.
o
Health plans will measure and disclose their performance on quality
measures (subject to State audit) and be accountable for maintaining and
improving the care their providers and practitioners deliver.
o
Purchasing cooperatives and other purchasers will use information on
quality of care to select and negotiate with plans; they will not be
responsible for collecting or validating the information.
o
State quality programs will gather data from plans, survey consumers,
prepare reports to inform consumers and providers, transmit collected data
to the Federal program, and help providers improve their care. State
licensing programs will assure that institutional providers meet standards
and that health plans meet conditions of participation. Federal contracts
and grants will support the core of State efforts (annual budget $238M).
o
The Federal government (annual budget $70M) will develop quality
measures and consumer surveys, support the research and pilot projects
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necessary for quality measurement, develop performance-based licensing
standards for institutions, prepare annual reports on Federal and State
efforts.
C. Information on quality. The system will measure access to care,
appropriateness of care, outcomes of care, and consumer satisfaction. Information will
come from records routinely generated in the process of providing care and from
consumer surveys. The Federal government will define a core set of measures to be
reported by plans and will define the core of a survey to be conducted by States; States
will add measures and survey questions that fit local priorities. Some validated measures
are available today, but increased research activity and improvements in patient care
data systems will make measures both more accurate and more broadly applicable over
the next few years; for the present, plans will have to abstract some medical records as
well as process automated data in order to apply some measures. The State will
combine information reported by plans with that developed by surveys into a report that
describes plans on perhaps 50 measures and describes institutional providers and
individual practitioners on a smaller number of measures for which adequate
information is available. The State analysis will include trends and other information
indicating the success of quality improvement activities. Each user (such as a purchasing
cooperative) will select and organize this information for its own needs. The measures
will change over a period of years in order to cover a wide range of quality issues, reflect
medical progress, and assure that measures remain representative of overall plan
performance.
D. Technical Assistance. States will give plans, providers, and practitioners
technical assistance to help them to measure their performance accurately and to
improve that performance. Assistance will include convening groups of providers with
similar problems, leading efforts to identify the root causes of problems, suggesting
solutions that have proven successful for other providers, and coordinating community
and provider efforts. Technical assistance in quality improvement will emphasize areas
where there is diminished competition and problems that exist across plans. Plans,
providers, and practitioners will not be required to accept assistance and assistance will
not be tied to licensure or payment. The national program will develop technical
assistance methods and fund State technical assistance programs. Medicare Peer Review
Organizations (PROs) are already piloting important parts of this proposal in their new
contracts and will immediately begin to pilot others; when the Medicare population
comes under protection of the quality management system, PROs will be discontinued.
E. Consumer protection and essential standards. There will be essential standards
for providers in three areas:
1. Health plans. To participate, plans must meet basic conditions including: 1)
fiscal soundness; 2) truth-in-marketing standards; 3) policies for protecting patient
privacy and confidentiality; 4) disclosing their performance and other information;
5) providing formal appeals and grievance procedures; 6) disclosing their
utilization management protocols; 7) promulgating enrollee rights and
responsibilities; 8) achieving quality improvement, and 9) reporting required
quality measures to the State. The conditions will be set by federal legislation,
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but administered and enforced by States.
2. Clinical Laboratories. The Clinical Laboratories Improvement Act (CLIA)
will be dramatically simplified to focus on quality control procedures, test
accuracy, and specimen handling. Mandatory proficiency testing will be
eliminated; labs will no longer pay fees and file forms to be waivered (about a
third of labs). Further exemptions will follow unless 1993 survey results indicate
need for continued surveys.
3. Institutional providers. The Federal government will develop performance
standards, largely based on outcomes, which will operate through State licensure
and will, over the next 5 years, replace both the current program of Medicare and
Medicaid certification and current State licensure. Federal incentives will be the
primary tool for strengthening and simplifying State practices. Focusing surveys
on providers with problems, will reduce both program costs and provider burdens.
F. National oversight. The President will appoint a National Quality Advisory
Committee, which will oversee the national program and its annual reports on
performance of the national and State programs. The Committee will also review the
report card, all State waivers, and development of performance-based licensing. The
Department of Health and Human Services should begin to design an evaluation of the
impact of health care reform on quality of care without waiting for passage of legislation.
G. Guideline Development Utilization Management, and Closely Related
Research. To support activities directly related to the report card and quality
improvement the Federal government will
o
develop the practice guidelines necessary for measures on the report card
and for the measures of institutional performance that will replace existing
requirements for licensure and certification,
o
support research on topics central to quality management, including
dissemination methods, quality measurement, and design of information
systems.
o
develop methodological standards for guidelines and a voluntary evaluation
and certification process for guidelines,
o
develop standards for utilization management protocols,
o
disseminate information on clinically ineffective uses of treatments, and
o
set priorities for evaluation research to support clinical practice guidelines,
define specific research projects related to these priorities and carry out
these projects (year 1: $35M; year 5: 95M).
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DETAILED DESCRIPTION OF QUALITY MANAGEMENT SYSTEM
Tabel of contents
I.
Responsibilities of the Secretary of Health and Human Services
A.
The National Quality Management Program
1.
Purpose.
2.
Governance
a.
National Advisory Committee
b.
3.
4.
B.
C.
D.
E.
II.
Duties of committee
c.
Annual Reports.
Financing & budget
a.
Federal activities
b.
State Quality Programs: contracts & grants to States
c.
Evaluation research
Activities. The NQMP shall a.
Define performance reports
b.
Define standard formats for reporting
c.
Define the sets of measures
d.
Pilot-test the measures
e.
Set the national performance goals
f.
Develop and specify a standard consumer questionnaire
g.
Specify procedures in conducting consumer surveys
h.
Establish the sampling strategies....performance information
i.
Define standards for data plans... must maintain
j.
Set priorities for research to support the report card
k.
Set priorities for evaluation research
I.
Establish standards for SQPs
m.
Monitor the performance of SQPs
n.
Provide technical assistance to SQPs
o.
Carry out activities related to standards for health care facilities
p.
page 1
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Conduct activities related to Conditions of Participation
q.
Standards for clinical practice guidelines
page 9
r.
Carry out a program for evaluating utilization control protocols.
s.
Consumer protection guidelines.
t.
Contracts and grants administration, to support the SQPs.
page 10
Standards for Health Care Facilities.
1.
The NQMP shall oversee a transition
page 11
2.
Federal Standards for Clinics and Practitioners.
page 12
3.
Standards for Clinical Laboratories.
page 13
Oth«r Existing Federal Quality Programs.
page 14
1.
HMO regulation.
2.
Medicare Peer Review Organizations (PROs).
Evaluation Research.
Information for Policy Development.
page 15
State responsibilities.
A.
State Quality Programs
1.
Governance, Financing and Budget.
2.
page 17
Activities.
a.
Educate regarding measures
b.
Develop locally-appropriate
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C.
D.
E.
F.
G.
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c.
Receive and audit reports from health plans
d.
Develop survey questions relevant to local concerns
e.
Conduct consumer surveys.
f.
Receive and review health plan disclosure documents.
g.
Publish the report cards
h.
Educate consumers on the interpretation
i.
Offer technical assistance
j.
Provide a mechanism for appeal of grievances
k.
Maintain a formal policy privacy and confidentiality
I.
Comply with requests for information from the Secretary
m.
Ombudsman program
State Licensure Programs.
Reporting to Secretary.
Each State must make available to the Secretary
Waivered States
Benchmark Plans.
Conditions of Participation for Plans.
Responsibilities of Purchasers
A.
Use comparative information on quality
B.
Distribute the report card
C.
Provide enrollment information requested by the SQP,
D.
Work with the SQP on quality management and improvement projects
E.
Oversee requests by consumers to disenroll for cause
F.
Provide a mechanism for appeal
G.
Comply with requests from the Secretary for information
page 2
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Responsibilities of Health Plans
A.
V.
VI.
Conditions of Participation for health plans.
1.
Fiscal Soundness.
2.
Marketing.
3.
Credentialing.
4.
Enrollee Rights and Responsibilities.
a.
Disclose to consumers
b.
Enrollee Appeal Rights.
5.
Privacy.
6.
Other Complaints.
7.
Disenrollment for Cause
8.
Utilization Management: plan must disclose its protocols.
9.
Internal Quality Management
10. Data Management and Reporting.
B.
Responsibilities of other health plans. Non-participating health plans
C.
Comply with requests for information
Responsibilities of Health Care Facilities
A.
State licensure requirements
B.
Standards established by the NQMP under l.B.
C.
Requests for information
Responsibilities of Practitioners. Requests for information
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DETAILED DESCRIPTION OF QUALITY MANAGEMENT SYSTEM
For Legislative Drafting, Regulation Development, and Administration
(Attachment A-rev discusses several general issues in this design)
I.
Responsibilities of the Secretary of Health and Human Services (the Secretary)
A.
The National Quality Management Program
1.
Purpose. The Secretary shall establish a National Quality Management
Program (NQMP) to develop and annually update the national framework by
which health plans and providers protect consumers, improve quality of
health care, facilitate choice based on quality as well as cost, and maintain
their public accountability.
2.
Governance. The Secretary of the Department of Health and Human
Services shall carry out the activities of the NQMP.
a.
The President shall appoint a National Quality Advisory Committee for
the NQMP, which shall
(1)
have 15 members, who shall be appointed for staggered 5-year
terms,
(2)
include representatives of consumer groups, health care
providers, health plans, purchasers of care, the long-term care
community, the alcohol-drug-mental health community, and
experts in quality of care and related research fields.
(3)
advise the Secretaries of the Department of Health and Human
Services, Defense, Veterans Affairs, and other affected agencies
regarding quality issues in the implementation of National Health
Reform, and review and make recommendations on (a)
(b)
the performance report content and format specified in
4.a..
(c)
the priority lists for research projects developed under 4.j.
and k.
(d)
the reports to Congress and the States in 2.c.
(e)
the research agenda of the NQMP, and
(f)
b.
the NQMP,
all waivers and exceptions granted to States.
Annual Reports.
(1)
The Secretary shall provide an annual report to the Congress on
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the activities of the NQMP and the quality of health care under
health care reform.
(2)
The Secretary shall provide an annual report to the States on the
comparative performance of State Quality Programs (SQPs).
This report shall include, at a minimum:
(a)
Performance along a relevant subset of the measures
defined under 4.a.
(b)
Compilations of responses to a relevant subset of the
nationally uniform measures on the consumer
questionnaire defined under 4.f.
(3)
(4)
not for the law
3.
Jf other sections of the National Health Reform Act provide for
the formation of uniform enrollment and encounter data bases,
to be maintained at the state level and to be connected by an
electronic network, then the Secretary shall make this data
available for internal and external analyses related to quality,
including studies of trends in outcomes, variation in prevalence
of conditions, patterns of services and outcomes of care, and
shall include results of these analyses in the reports to Congress
and the States specified in (1) and (2).
The Secretary should immediately (i.e., June 1993, prior to
passage of health reform legislation) begin design, and any
necessary procurement activities, for the initial evaluation of the
impact of health care reform on quality of care. This will enable
baseline measurement of quality prior to reform and will
accelerate the date when the initial evaluation can be published.
Financing & budget (see Attachment B-rev for a summarv of fiscal impact)
a.
National Quality Management Program. There is authorized to be
appropriated for the purposes of carrying out Federal activities under
the National Quality Management Program, $62 million for FY1, $64
million for FY2, $61 million for FY3, $58 million for FY4 and $60 million
for FYS (see Attachment C-rev for budget detail).
b.
Survey. Certification, and Licensure. The Federal funding of survey
and certification will remain substantially unchanged when some of
these functions are transferred to State licensure (see B.1), but the
allocation of these funds among programs and budget lines cannot be
defined until other organizational decisions are made.
c.
State Quality Programs, (see Attachment D-rev for budget detail)
(1)
There is authorized to be appropriated for the purposes of
Federal contracts with States to carry out State Quality Programs
(SQPs) under II.A., $202.7 million for FY1, $208.8 million for FY2,
$215 million for FY3, $221.5 million for FY4 and $228.1 million
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for FYS.
(2)
(3)
d.
4.
There is authorized to be appropriated for the purposes of
Federal grants to States to carry out State Quality Programs
(SQPs) under II.A., $85.5 million for FY1, $88.1 million for FY2,
$90.7 million for FY3, $93.4 million for FY4 and $96.2 million for
FYS.
There is authorized to be appropriated for the purposes of
Federal grants to States to support innovative approaches within
the State Quality Programs (SQPs) under II.A., $15 million for
FY1, $15.5 million for FY2, $16 million for FY3, $16.5 million for
FY4and $17 million for FYS.
Evaluation research. There is authorized to be appropriated, in
addition to existing authorizations for research evaluating medical
treatments, $35 million in FY1, $50 million in FY2, $65 million in FY3,
$80 million in FY4 and $95 million in FYS for projects under this
section (see Attachment C-rev for budget detail).
Activities. The NQMP shall a
Define (and revise as appropriate) the content and format of
performance reports, to be generated by SQPs and plans, that can be
used by consumers to make comparisons based on quality. The
reports produced by SQPs shall include comparative quality
information on health plans, purchasers, health care facilities and
health care practitioners within a state. The reports must include (see
Attachment E-rev for an estimate of the burden on plans, providers,
and practitioners):
(1)
with respect to health plans, descriptions of organizational
structure, service areas, and locations where various clinical
services are available,
(2)
performance on a selected number of measures of access,
appropriateness, outcomes, and patient satisfaction (including
measures collected through the consumer survey in 0- These
sets of measures will vary depending upon the type of entity for
whom the information is presented.
(a)
With respect to health plans, the NQMP would initially
define a core set of measures that all states would be
required to include on the plan performance report. The
NQMP would also define optional measures that any state
could choose to include on its plan performance report.
(States would also receive funding to develop additional
measures). Both the required and optional sets of
measures would include specialized measures for
assessing the quality of services such as home health
care, long-term care, and mental health, after such
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measures have been developed. (See Attachment F-rev for
an example of the types of measures that might be used
to assess overall plan performance.)
(b)
With respect to facilities, the sets of measures will include
some of the performance measures used for Federal
certification and state licensure of those facilities under the
revised standards established in B.
(c)
With respect to facilities and practitioners, measures
selected to assess their performance will i)
only be made available after experience has shown
the measures to be valid
ii)
only be presented in cases where the sample size is
adequate to enable valid calculation.
(3)
time trends on a subset of the measures in (2).
(4)
performance on the nationally uniform measures collected
through the consumer survey in f.
(5)
Annual goals for national performance along the measures of
access, appropriateness and outcomes.
and, when such measures are available, measures used for licensing
of those health care facilities used by plans.
b.
Define standard formats, which may be electronic, for reporting of the
measures and other information used in the performance report
specified in a. to SQPs and the NQMP.
c.
Define (and revise annually, if appropriate), the sets of measures
referenced in a. and the methods to be used in generating these
measures. The NQMP shall use the following criteria in selecting the
sets of measures:
(1)
The set should be representative of the range of services
provided to consumers by the entities in question, relate to
conditions that occur frequently, and distinct from one another.
(2)
Performance on measures included in the set should vary widely
among the entities on the performance report.
(3)
The measures should be reliable and valid, and data needed for
calculation should be obtainable without undue burden, given
the information systems required under section xxxx of this Act.
(4)
When the measures are rates of processes of care, these
processes should be linked by strong scientific evidence to
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health outcomes.
(5)
When the measures are outcomes of care, there should be
strong scientific evidence that performance on the measures is
within the control of the entities in question and that adequate
risk adjustment is included.
d.
Assure that the measures in c , are tested before making them core or
optional (a.(2)(a)) measures for any performance report.
e.
Set the national performance goals specified in a. (5). The Secretary
shall seek to define goals that are (1)
achievable,
(2)
based on the actual performance of significant numbers of
successful health plans or providers, and
(3)
based on the best scientific evidence about optimal practice
patterns.
f.
Develop and specify a standard consumer questionnaire for use by
SQPs in conducting consumer surveys (see Attachment G-rev for
discussion of questionnaire). The questionnaire should be designed
to obtain a core set of nationally uniform information reflecting
consumer experiences with a reformed health care system. It should
include measures of satisfaction, access and health outcomes.
g.
Specify procedures (general parameters as to sample size, the
manner in which samples are to be drawn, survey administration and
the coding and processing of uniform measures) that SQPs must
follow in conducting consumer surveys which will assure:
(1)
(2)
that information is captured about all settings of care,
(3)
that samples are designed to allow comparisons among plans
and generalization to the entire state population,
(4)
h.
that surveys are population-based and not limited to users of
health care or enrollees of particular heaJth plans,
that conclusions can be drawn regarding populations potentially
vulnerable to problems with access and quality. These
populations may include non-English-speakers, low-income
populations, migrant workers, residents of inner cities and rural
areas, racial and ethnic minorities, the disabled, mental health
patients, nursing home residents, AIDS patients and those who
have recently disenrolled from a health plan.
Establish the sampling strategies (including strategies to oversample
low income, underserved and vulnerable populations as well as those
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(2)
take maximum advantage of information systems improvement
resulting from section xxxx of this Act;
(3)
identify the projects required for the implementation of the
measures in (1), including (a)
(b)
technology assessments
(c)
(4)
projects necessary to develop the measures, such as
evaluations of validity and reliability of alternative quality
measures, determination of the optimal design of
information systems and identification of dissemination
methods,
development or refinement of clinical practice guidelines
identify the market research necessary on consumer use of
comparative information, in order to:
(a)
support development of priorities under (1), for quality
measures that consumers will find useful, and
(b)
support development of usable performance report formats
and supplementary information for inclusion in the
performance reports;
(5)
(6)
k.
identify the projects necessary to identify and measure trends in
quality of care in the nation, to support the annual report to
Congress in A.2.c.
The Secretary shall carry out the activities identified under (3),
(4) and (5) using funds appropriated for the NQMP.
set priorities for health care evaluation research (including medical
effectiveness research, clinical trials of therapies, and other projects)
to support development of clinical practice guidelines. The NQMP,
with the advice of the National Quality Advisory Committee, shall
annually (1)
define priorities for health care evaluation research which targets
areas with:
(a)
(b)
the greatest variation in practice patterns,
(c)
significant cost to the health care system, and/or
(d)
(2)
the greatest medical uncertainty in treatment,
significant burden to the population;
recommend specific research projects to be conducted, related
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to the priorities developed under (1); and
(3)
I.
recommend to the Secretary a level of funding necessary to
carry out the projects under (2). (See section I.D. for
authorization of appropriations).
Establish standards for SQPs (see section II), which must include:
(1)
Organizational independence from purchasers, health plans and
providers.
(2)
A process for receiving input from consumers, providers,
practitioners, health plans and purchasers.
(3)
The SQP must carry out the activities listed in II.A.2.
(4)
Making available to the NQMP information provided by plans,
providers, and practitioners to the SQP on performance
measures, enrollment, and services. The Secretary shall
establish by regulation the way(s) in which this information shall
be made available to the NQMP and shall include protection
against unauthorized disclosure at least as rigorous as those
afforded by the Privacy Act.
m.
monitor the performance of SQPs in carrying out their activities.
n.
Provide technical assistance to SQPs, in areas related to data
integrity, data analysis, development of measures, including measures
for collection through consumer surveys, dissemination of information,
and provision of technical assistance to health plans under II.A.2.i. To
support this technical assistance, the NQMP shall maintain a library of
previously-developed measures, including measures for collection
through consumer surveys, and instruments for collection of
information for determination of the measures.
o.
Carry out activities related to standards for health care facilities, as
specified in B.
p.
Conduct activities related to Conditions of Participation for health
plans, including:
(1)
Setting Conditions of Participation for health plans, as specified
in IV.A., below.
(2)
Contracting with States to certify the compliance of plans within
their borders with conditions of participation and to review plan
disclosure documents.
(3)
Evaluating applications from private accreditation organizations
as to whether their accreditation standards and processes would
provide reasonable assurance that the Conditions established
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under (1) are met.
(4)
Waiving the requirement for Federal certification of facitKies for
those facMes accredited by organizations whose standards are
approvea u'nde? (3).
(5)
Setting rules governing required disclosures of information by
plans, including:
(a)
Defining, and revising annually, standards for required and
permitted disclosure by plans to consumers in annual
enrollment documents. Required disclosure would include
measures in the performance report specified in a.,
descriptions of organizational structure, service areas,
clinical services, utilization control protocols, and other
information. (See Attachment "Legal Framework for
National Quality Management Program"). The Secretary
may reduce disclosure requirements for startup plans.
(b)
Defining standards for advertising and marketing practices
by plans.
(c)
OPTION: Review plan disclosure documents, provide
technical assistance to plans regarding disclosure, and
refer inadequate or fraudulent disclosure to appropriate
enforcement authorities.
q.
Carry out a program to establish non-binding, science-based
standards for clinical practice guidelines and procedures for
evaluating guidelines according to those standards, and evaluate any
guidelines voluntarily submitted for review. (It is anticipated that a
peer review process similar to that used to review research proposals
would be used to evaluate submitted guidelines.)
r.
Carry out a program to establish non-binding, science-based
standards for and develop procedures for evaluating the clinical
appropriateness of utilization control protocols, including methods of
application.
OPTION: Evaluate any protocols voluntarily submitted for review. (It is
anticipated that a peer review process similar to that used to review
research proposals would be used to evaluate submitted guidelines,
and disseminate information on successful, clinically appropriate
utilization control strategies).
s.
Consumer protection guidelines. To protect consumers from use of
services in circumstances in which they are of no value, the Secretary
shall
(1)
develop and regularly update a list of clinical services that are
widely used in circumstances where they provide no benefit to
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patients, ranked by estimated potential benefits from omitting
these sen/ices, and
(2)
t.
develop consumer protection guidelines describing precisely the
clinical circumstances in which evidence shows that the clinical
services identified in (1) are of no benefit to patients.
Contracts and grants administration. The NQMP shall administer a
program of contracts and grants to support the SQPs as described at
I.A.3.C.
(1)
Contracts to SQPs shall be used for:
(a)
education of purchasers, plans and providers, under
II.A.2.a.
(b)
oversight of health plan performance reports, under
II.A.2.C.
(c)
conduct of consumer surveys, under II.A.2.e.
(d)
review of health plan disclosure documents, under II.A.2.f.
(e)
publication and dissemination of performance reports,
under II.A.2.g.
(f)
education on how to interpret the performance reports,
under II.A.2.h.
(g)
A grievance appeals mechanism under II.A.2.j.
(h)
The ombudsman program under II.A.2.m.
The Secretary shall develop a formula for allocation of these
funds among States.
(2)
Grants to SQPs shall be used for:
(a)
Development and pilot-testing of local quality measures,
under II.A.2.b.
(b)
Development and pilot-testing of locally-relevant consumer
sun/ey questions, under II.A.2.d.
(c)
Technical assistance on methods to improve care, under
II.A.2.I.
The Secretary shall develop a formula for allocation of these
funds among States.
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(3)
B.
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The Secretary shall make grants to SQPs to support innovative
approaches to improving quality of care.
Standards for Health Care Facilities.
1.
Correction of deficiencies should be initially and primarily based on
principles of internal quality improvement. Standards will serve as a floor to
assure that severe deficiencies are identified and promptly remedied.
(Because economic incentives in the nursing home industry do not now
reinforce and support internal quality improvement, nothing in this section
shall nullify the standards for long-term care facilities contained in OBRA87.)
The NQMP shall oversee a transition from the current program of Federal
certification of health care facilities participating in the Medicare and
Medicaid programs to a program of State licensure according to
performance-based standards for facilities. This transition shall have three
stages a.
In the first stage, the NQMP shall
(1)
Define a list of types of health care facilities for which
performance standards will be established;
(2)
Develop standards that health care facilities listed under (1) will
be required to meet in order to receive payment from
participating health plans, purchasing alliances, purchasers
receiving Federal tax deductions for their health insurance
premiums, any remaining Federal health insurance programs,
and any long-term care insurance program established under
health care reform. These standards must reflect essential
performance requirements that focus on patient care and
outcomes. All other standards except In the areas of fire
safety, sanitation and patient rights will be phased out.
(3)
Develop methods for certifying that facilities meet these
standards. The method shall eliminate facility surveys except for
(a)
(b)
Response to complaints, and
(c)
(4)
Facilities with aberrant performance,
Random sample validation surveys.
By the beginning of FY4, the NQMP shall complete
demonstration projects of the standards developed under (2),
and shall revise those standards according to the findings of the
demonstration projects. The demonstration projects must
evaluate
(a)
the overall impact of these standards in assuring quality of
care, and in improving care, and
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the cost and burden the standards and the certification
process impose on facilities.
Apply the new standards to Federal certification of all facilities in
a.(1)
In the second stage, when new standards have been piloted,
encourage States to adopt these performance expectations as their
licensing standards.
(1)
(2)
Through its contracts with States and liaison with other
Government agencies, the NQMP shall coordinate all inspection,
certification, and licensing activities pertaining to each facility so
as to minimize the number of inspection visits and the amount of
paperwork required of each facility.
(3)
c.
The NQMP shall provide technical assistance to States in
developing and carrying out licensure using the Federal
essential standards defined under a.
As an incentive to States to adopt the new standards, the
Secretary may pay part or all of the costs of State licensure
programs that meet the objectives of moving to performancebased regulation, reducing total regulatory burden, and
promoting internal facility quality improvement programs.
In the third stage, discontinue Federal certification activities in all
States where State licensure is substantially equivalent and maintain
only sample surveying to assure that equivalence is maintained. The
NQMP shall:
(1)
determine whether State licensure requirements for health care
facilities are substantially equivalent to the essential standards
for Federal certification; and whether a State deems to be
licensed any facility accredited by an accreditation organization
approved by the Secretary under (4).
(2)
waive the requirement for Federal certification of facilities in
States where substantial equivalence and deeming was
determined under (1).
(3)
During the transition, assure that no facility listed in a.1. would
operate without either a Federal certificate or a State license that
had been determined to be substantially equivalent.
(4)
evaluate applications from private accreditation organizations as
to whether their accreditation standards and processes would
provide reasonable assurance that the standards established
under (1) are met, and waive the Federal requirement for
Federal certification/licensure for those facilities accredited by
organizations whose standards are so approved.
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Federal Standards for Clinics and Practitioners. Quality standards for -
a
Rural health clinics
b.
Federally qualified health clinic services
c.
Occupational, physical, and speech therapists
established under Titles XVIII and XIX of the Social Security Act are
repealed.
3.
Standards for Clinical Laboratories.
a.
All requirements under the Clinical Laboratory Improvement Act of
1988 (CLIA) that laboratories engage in proficiency testing are
repealed.
b.
All requirements that apply to waived tests and physician-performed
microscopy (as defined in current regulations) are repealed.
c.
Unless the Secretary of HHS reports to Congress that the rates of
failure to meet CLIA standards justify continued certification of specific
classes of labs, CLIA requirement will be repealed as of FY2 for all
other laboratories except (1)
labs that conduct a comprehensive menu of tests,
(2)
labs that conduct a large volume of tests,
(3)
labs that engage in critical specialized testing (e.g.: Pap
smears), and
(4)
labs that conduct testing to monitor care while it is being
delivered, such as dialysis labs.
Most physician office labs would be deregulated unless current
surveys indicate significant problems.
d.
As of the beginning of FYS, the remaining provisions of CLIA are
superseded by the standards developed under e.-f.
e.
By April 1 of FY2, the Seeretaty shall develop and publish in the
Federal Register standards that the classes of laboratories identified in
a.(1)-(4) must meet in order to receive payment from participating
health plans, purchasing alliances, purchasers receiving Federal tax
deductions for their health insurance premiums, any remaining
Federal health insurance programs, and any long-term care insurance
program established under health care reform. The standards must
include:
(1)
Standards for laboratory quality programs (either adherence to
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the manufacturer's quality control system for equipment or
adherence to a comparable set of internal quality control
procedures; this eliminates such requirements as staff training
levels);
(2)
(3)
C.
Standards for the accuracy of cytology tests, including Pap
smears; and
(4)
f.
Standards for laboratory test accuracy;
Standards for accuracy in handling specimens and reports.
By April 1 of FY2, the Secretary shall also develop and publish in the
Federal Register methods for certifying that facilities meet the
standards in c. These methods are anticipated to include
requirements for on site inspections of labs.
Other Existing Federal Quality Programs.
1.
HMO regulation. At such time as the NQMP has developed Conditions of
Participation for health plans a.
b.
2.
standards for HMOs established under the Federal HMO Act, and
under Titles XVIII and XIX of the Social Security Act shall be
superseded by those Conditions.
the Conditions of Participation for health plans shall apply to HMOs
participating in the Medicare and Medicaid programs.
Medicare Peer Review Organizations (PROs).
a.
b.
Requirements for physician attestation of discharge diagnoses and
procedures, validation of DRG assignment, and annual
acknowledgement of penalties for inaccurate reports are repealed.
c.
HCFA shall report annually to Congress on the implementation of the
PRO program's Health Care Quality Improvement Initiative, (the PRO
ongoing quality improvement program, which is the basis for PRO
contracts beginning in April, 1993) including the progreun's impact in
improving processes of care and patient outcomes.
d.
D.
At such time as the Secretary determines that all Medicare enrollees
are enrolled under the National Health Care Reform Program, Part B
of Title XI of the Social Security Act shall cease to have effect.
The PROs shall conduct pilot projects in Medicare risk HMOs of the
quality assurance methods under the proposed SQPs described in
II.A.
Evaluation Research. The Secretary shall carry out evaluation research projects
(including projects in medical effectiveness research, technology assessments
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clinical trials, and other types of projects) related to the priority areas identified by
the NQMP under A.4.k (see Attachment H-rev for the science base of this activity).
In selecting the projects to be carried out, the Secretary shall take into
consideration the specific projects, and funding levels for those projects,
recommended by the NQMP under A.4.k.
E.
Information for Policv Development.
1.
For the purpose of:
a.
Conducting studies to support:
(1)
Preparation of the annual reports under A.2.C.
(2)
Development of the performance report format specified under
A.4.a.
(3)
Definition and development of quality measures and the
methods to be used in generating those measures
(4)
Development and definition of a consumer questionnaire under
A.4.e.
(5)
Other policy development activities, as specified by the
Secretary through a process of notice and comment.
b.
Establishment of essential standards for Federal certification of
facilities under B.l.b. and B.4.
c.
Revision of clinical laboratory standards under B.3.c.-e.
d.
Conducting look-behind audits of SQP performance under A.4.m.
the Secretary shall have the authority to examine clinical records of SQPs,
purchasers, health plans, providers and practitioners receiving funding or
tax deductions under health care reform.
2.
OPTION: Use of Records for Evaluation Research a.
For Vhe purposes of carrying out the evaluation research projects under
D., the Secretary (and investigators under contract with the Secretary)
shall have the authority to examine clinical records of SQPs,
purchasers, health plans, providers and practitioners receiving funding
or tax deductions under health care reform, subject to the conditions in
c.
b.
The Secretary shall appoint a review board to review all proposals to
use private sector data for evaluation research under this authority.
This board may be the same as, or distinct from, the board that is
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responsible for reviewing requests for computerized data matches
under the Privacy Act
c.
Proposals to examine records under a. must be approved by the
review board established under b. In determining whether to approve
a proposal, the review board must consider (1)
(2)
3.
The burden the data request would place on the SQPs,
purchasers, health plans, providers and practitioners, and
(3)
d.
The priority level given the research project by the NQMP under
A.4.k.
The operational protection for privacy and confidentiality
proposed for the project
Review board decisions must be made in accordance with timeliness
standards established by the Secretary.
Records provided to the Secretary under 1. and 2. -
a.
Shall not be used for the purpose of making any determination with
respect to payment, participation, standards compliance or civil or
criminal penalty about individual providers, plans, practitioners or
patients.
b.
Shall be protected as trade secrets under 18 USC 1905 (which
provides for civil and criminal penalties for disclosure)
c.
Shall be considered as trade secrets for the purposes of the Freedom
of Information Act and shall therefore be exempt from disclosure
under 5 USC 552(b)(4) of that Act.
d.
Shall not be used by any person to his own advantage or revealed,
other than to the Secretary or officers or employees of the Department
of HHS, or to the courts when relevant in any judicial proceeding
related to this Act. (This provision is parallel to a prohibition under the
Food, Drug and Cosmetic Act, 21 USC 331 (j).)
(Note: identifiable information about individuals will also be protected under
the Privacy Act - no special legislative provision needs to be added for
this.)
4.
The provisions under 3. shall not be construed to prohibit the release of
aggregate statistical information which does not identify any individual or
entity.
5.
The Secretary shall make payment for the reasonable cost of retrieving and
providing records provided under 1. and 2.
6.
The Secretary shall allow reasonable time for retrieval and provision of
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records requested under 1. and 2.
7.
II.
Penalties for Failure to Comply. Any purchaser, health plan or health care
provider that refuses or willfully neglects, when requested by the Secretary
to provide information under this section, within the reasonable time
specified under 5. shall be subject to exclusion from programs under this
act, including ineligibility for tax deductibility of payments for care.
State responsibilities.
A.
State Quality Programs
1.
Governance. Financing and Budget. In order to receive any funds under
this act. a State must establish a State Quality Program that meets the
standards established by the NQMP under I.A.4.1.
2.
Activities. The SQPs must a.
Educate purchasers, plans and providers regarding measures
(including those defined under I.A.4.a.) and data collection.
b.
Develop locally-appropriate, scientifically-valid quality measures, to be
included on local performance reports of the type defined in I.A.4.a.,
to supplement the core of measures in I.A.4.a. SQPs may opt to
select these measures from the optional measures defined by the
NQMP under I.A.4.a.
(1)
Define standards for data that purchasers, health plans,
providers, practitioners and groups of practitioners must
maintain in order to support determination of these measures.
(2)
Develop and specify methods for determining these measures.
(3)
Pilot-test the measures.
c.
Receive and audit performance reports from health plans, and provide
technical assistance to improve data accuracy.
d.
Develop survey questions relevant to local concerns , such as
particular health plans within the State, or particular populations and
geographic areas, in order to produce meaningful information to
support consumer choice, for inclusion in the consumer survey
defined by the Secretary under I.A.4.f., and pilot-test the questions.
e.
Conduct consumer surveys. These surveys must:
(1)
include the nationally uniform questions defined by the
Secretary under I.A.4.f.
(2)
comply with any other requirements specified by the Secretary
under I.A.4.f.
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(3)
Be conducted using the sampling strategies specified by the
Secretary under I.A.4.g.
(4)
Include questions relevant to local concerns developed under d.
f.
Receive and review health plan disclosure documents. If the National
Quality Management Program reviews health plan disclosure
documents, States may elect to rely on the Federal review.
g.
Publish the performance reports defined in I.A.4.a., including any
locally-defined measures developed under b. and d., and distribute
the information in the performance reports to purchasers, plans,
providers and practitioners.
h.
Educate consumers, purchasers, providers and practitioners on the
interpretation of information contained in the performance reports.
i.
Offer technical assistance on methods to improve care to plans,
providers, and physicians. Technical assistance may include (1)
fostering collaboration among plans, providers or plans,
providers and consumers to deed with common problems and
sharing information on improvement,
(2)
formation of clearinghouses that maintain information on
successful improvement projects, quality measures, practice
guidelines and research findings,
(3)
feedback of data on performance
(4)
assistance in incorporating consumer feedback mechanisms into
internal quality management activities,
(5)
medical record audits to help providers understand problems,
(6)
advice on clinical or management strategies that have proven
effective in improving performance, and
(7)
other approaches developed locally or Statewide.
(Attachment l-rev provides further information on technical assistance.)
j.
Provide a mechanism for appeal of grievances not resolved at the
purchaser level. Grievances not resolved at the SQP level would be
appealable to the courts.
k.
Maintain a formal policy for protecting patient privacy and
confidentiality that complies with applicable state and federal law,
I.
Comply with requests for information from the Secretary under I.E.
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Operate an ombudsman program analogous to that of the long-term
care ombudsman program in the Older Americans Act and to the
State health insurance counselling program.
B.
State Licensure Programs. In order to receive a waiver under I.B.I .c. and to
receive supplemental funding from the Secretary for licensure and certification
activities under I.B.l.b. a State's licensure requirements for that type of health
care facility must be substantially equivalent to the Federal essential standards for
that type of facility established under I.B.I.a., and the State must deem to be
licensed any facility that is accredited by an accreditation organization approved
by the Secretary, as specified in I.B.I.c.(4).
C.
Reporting to Secretary. Each State must report to the Secretary, in such format
as the Secretary may require 1.
The nationally uniform information required for inclusion in the performance
report defined in I.A.4.a., on each entity within the State for whom a
performance report is required, and the data reported to the SQP on which
that information is based; and
2.
The nationally uniform survey data from the consumer surveys defined
under I.A.4.f.; and
D.
E.
Waivered States: In order to promote alternative quality strategies, the Secretary
may waive State requirements under II except that the State must submit to the
Secretary sufficient information from the core quality measures defined above and
from the core consumer survey defined above to provide information statewide
and for vulnerable populations designated for oversampling in I.
F.
Benchmark Plans. A State must use comparative quality information about health
plans in determining which plan will serve as its benchmark plan for premium
setting purposes, in order for any corporation or individual within the State to be
eligible for federal tax deductions for health insurance premiums.
G.
III.
Each State must make available to the Secretary for inspection, upon request, a
list of any facilities licensed by the State, and information on which licensure
decisions were based.
CondWons of Participation for Plans. Each State must enter into a contract with
the Secretary, as specified in I.A.4.p., under which the State will certify the
compliance of health plans located within its borders with the Conditions of
Participation specified in IV.A., and will review the documents disclosed by each
of these plans under IV.A.11.
Responsibilities of Purchasers (including purchasing edliances) In order for purchasers
and those corporations and individuals for whom they purchase health insurance to be
eligible for Federal tax deductions for their health insurance premiums, each purchaser
must A.
Use comparative information on quality in selecting participating health plans to
offer their consumers,
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B.
C.
Provide enrollment information requested by the SQP,
D.
Work with the SQP on quality management and improvement projects,
E.
Oversee requests by consumers to disenroll for cause, and arrange for the
consumer to immediately enroll in another participating health plan, so there is no
break in coverage, and
F.
Provide a mechanism for consumers, practitioners and providers to appeal
grievances not resolved at the health plan level; provide a mechanism, with full
due process and internal mechanisms for appeal, for grievances against itself (the
purchaser).
G.
IV.
Distribute the performance report specified in II.A.2.g. to all consumers for whom
they purchase,
Comply with requests from the Secretary for information under I.E.
Responsibilities of Health Plans. Health plans have a duty to disclose to enrollees and
potential purchasers all material information that a reasonable person choosing health
coverage would want to know and to file notices of material changes with the NQMP,
SQPs, and purchasing alliances.
A.
Conditions of Participation for health plans. In order to be Federally certified as a
participating health plan meet Conditions of Participation established 'by the
NQMP under I.A.4.p.(1) that relate to quality. These Conditions will include the
following:
1.
Fiscal Soundness. A participating health plan must a
b.
2.
meet minimum financial standards for reserves, loss ratios, etc, and
disclose its financial condition fully to all purchasers.
Marketing. The participating health plan must a
b.
disclose to consumers and SQPs in its annual enrollment document
ail material information regarding the plan, including information
described below in 3-10, and
c.
3.
meet standards for truth-in-marketing and fair marketing practices, and
provide immediate notice of material changes in such information to
the SQP.
Credentialing. The participating health plan must have a credentialing
process that ensures that all practitioners and facilities meet all licensure
standards set by all states in which they operate and practice, and, as
appropriate, by the Federal Drug Enforcement Administration. As part of
the credentialing process participating health plans must -
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a.
b.
check practitioners against the National Practitioner Data Bank,
under discussion with the malpractice group
c.
have a process for reviewing the credentials of practitioners and
licensure status of facilities, including carrying out b., at least every
two years,
d.
drop from the plan practitioners and facilities that fail to meet basic
standards of adequacy of care, or are responsible for fraud or
mismanagement,
e.
consider credible complaints against practitioners or providers,
f.
4.
check and consider the education, hospital privileges and board
certification status of practitioners and accreditation status of facilities,
report any sanctions taken against practitioners to the National
Practitioner Data Bank.
under discussion with the malpractice group
Enrollee Rights and Responsibilities. The participating health plan must
a.
disclose to consumers all material information regarding:
(1)
(2)
any out-of-pocket payments required,
(3)
any restrictions on the use of out-of-plan practitioners and
facilities,
(4)
the laws and regulations governing health plan operations,
(5)
the practitioners, providers and services available,
(6)
their treatment options,
(7)
the health plan grievance process, and
(8)
b.
their benefit coverage,
their rights and responsibilities under the plan.
Enrollee Appeal Rights.
(1)
In general. Each plan shall establish a process whereby
enrollees are notified of their rights of appeal and provided an
opportunity to appeal the denial, termination, or reduction of
coverage or payments for health care products or services.
(2)
Appeals Information. Each plan shall provide, in the major
languages used by its enrollees, written information briefly
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describing their appeal rights and the telephone number to call
for further information on such rights (a)
in information distributed to prospective enrollees;
(b)
in notices prominently posted in public areas of plan
offices and facilities;
(c)
in routine communications with enrollees;
(d)
with written notices described in paragraph (3);
(e)
at any time upon the request of an enrollee;
(3)
Reduction of services. When a significant reduction in services
to a patient is planned, the plan/practitioner shall obtain
informed consent or shall provide written notice of the plan's
intention to reduce services without the patient's consent.
Whether or not the patient consents, the patient shall receive a
written plan for care after the reduction, which shall include
notice of the right to appeal and a telephone number to call for
an appeal.
(4)
Disclosure. With respect to any denial, termination, or reduction
of coverage or payments for any health care product or service,
each plan shall provide to each enrollee upon request (a)
(b)
(5)
A clear statement of the reasons for the denial,
termination, or reduction of coverage or payments and
an explanation of the enrollee'srightof appeal, as well as
anyrightof further review of an appeal, and the process
used by the plan in resolving such appeals and
requirements for further review of an appeal.
Appeal process. The appeal process established by each plan
shall(a)
promptly provide to any enrollee requesting an appeal a
written acknowledgement of the appeal;
(b)
provide a response to the appeal within 10 days of the
date of acknowledging the appeal, except that the
Secretary may provide in regulation for a longer response
time under certain specified circumstances;
(c)
provide a written notice to the enrollee of the plan's
decision in regard to the appeal, with such notice to
include instructions as to how to proceed to a subsequent
level of review within the plan.
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Review of appeal. Each plan shall provide a process for further
review of an appeal upon request of an enrollee, in which (a)
(b)
5.
further review is to be completed within 30 days of
acknowledgment of the request (except the Secretary may
define in regulation circumstances under which completion
of further review may take a longer period of time);
(c)
(7)
a prompt acknowledgment is provided in response to a
request for further review;
a written notice is provided to the enrollee of the plan's
decision in regard to the request for further review of the
appeal, with such notice to include instruction as to how to
proceed to a subsequent level of review outside of the
plan.
Coverage or pavment pending appeal. A decision by a plan to
terminate or reduce coverage or payment for an ongoing
product or service shall be stayed, pending resolution of an
enrollee's appeal of such termination or reduced coverage or
payment, for a period of time to be defined by the Secretary in
regulation, when termination or reduction of coverage or
payment of the product or service would substantially increase
the likelihood of the enrollee's death or loss of function.
Privacy. The participating health plan must a.
maintain a formal policy for protecting patient privacy and
confidentiality that complies with applicable state and federal law, and
b.
allow patients to obtain copies of their medical records upon request.
6. Other Complaints.
a
The participating health plan must maintain a formal grievance
mechanism for receiving, investigating and resolving complaints about
practitioners, providers, treatments, access to care and health plan
policies and procedures.
.; b.
The grievance mechanism must include full due process and avenues
for appeal.
c.
7.
Grievances not resolved by the health plan may be appealed to the
purchaser.
Disenrollment for Cause. Depending on plan contracts with purchasers,
enrollees may be "locked in' to a given health plan for a year or other
period of time. Under this standard, an enrollee may disenroll from one
health plan at any time, for cause (e.g., inability to obtain an appointment
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for primeuy care, inability to obtain acutely-needed medical sen/ices, or
discrimination).
8.
Utilization Management. A participating health plan must disclose all its
protocols for controlling utilization and costs, including (but not necessarily
limited to):
a
b.
Compensation methods (e.g., capitation - not payment rates) for
providers and practitioners,
c.
Incentives to providers and practitioners to control utilization,
d.
Utilization review criteria, and
e.
9.
Methods by which the plan manages its network of practitioners and
providers, including criteria governing which practitioners and
providers are permitted in a network,
Protocols for managing high-resource cases
Internal Quality Management. Each participating health plan must
continuously improve the quality of its care, on measures such as improved
health outcomes and increased patient satisfaction. Each plan must also
correct problems identified through reported measures, internally-identified
patterns, risk management, and other means. The plan must both
cooperate with the SQP in improvement efforts and improve care
independently.
It will accomplish this improvement by (a) identifying problems, analyzing
underlying causes, and implementing and evaluating the impact of
attempted solutions; and/or identifying opportunities for improved
performance from such sources as syntheses of scientific information,
technology assessments and practice guidelines, (b) affirming the scientific
soundness and local applicability of such ideas, and (c) implementing and
evaluating the impact of practice changes.
Compliance with this Condition shall be measured by actual improvement
measures of health outcomes, processes, access and satisfaction.
Information demonstrating that improvement has occurred must be
maintained In auditable form.
(Note: the existence of organizational features such as quality assurance
committees and the operation of processes such as committee meetings
will not be sufficient to demonstrate compliance with this Condition).
10.
Data Management and Reporting. The participating health plan must a
maintain the data on all enrollees and encounters specified by the
NQMP under I.A.4.i. and by the SQP under II.A.2.b.(1), in such form
as the NQMP and SQP specify,
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b.
accurately determine and report the performance measures and other
disclosures.required by the SQP and the NQMP,
c.
report the data on which the measures were based in the format
defined by the NQMP, which will be such form that the SQP can
aggregate these data across plans by provider and practitioner, the
data used for risk adjustment, and the method for ensuring the
accuracy of the data collected,
d.
maintain records of the process for determining the measures in a
form auditable by the SQP.
B.
C.
V.
Responsibilities of other health plans. Non-participating health plans (if any exist)
are required to comply with all the Conditions of Participation specified under A.
All health plans must comply with requests by the Secretary for information under
I.E.
Responsibilities of Health Care Facilities
A.
B.
In order to receive payment trom participating health plans, purchasing alliances,
purchasers receiving Federal tax deductions for their health insurance premiums,
any remaining Federal health insurance programs, and any long-term care
insurance program established under health care reform, a health care facility
must meet the standards established by the NQMP under l.B.
C.
VI.
In order to operate within a State, a health care facility must meet the State
licensure requirements for its facility type.
Health care facilities must comply with requests by the Secretary for information
under I.E.
Responsibilities of Practitioners. Practitioners must comply with requests by the
Secretary for information under I.E.
ll«-A:\TOUJREVJICl
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ATTACHMENT A
KEY PREMISES I N DESIGN OF Q U A L I T Y M A N A G E M E N T SYSTEM
Premise A. The quality management system covers care paid for by all third parties, not
just the HIPC.
Rationale. Although this strategy is costly and virtually precludes placing quality
management entirely within the HIPC, it is important to preventing the
emergence of a two-tier system. Comprehensive measurement allows
comparisons among large programs, introduces competitive elements into them,
and standardizes performance data collection so as to simplify life for all plans
and providers. This approach will provide comparative data to non-HIPC
employers and to HIPC enrollees, reassuring both that their care is comparable to
that of others).
Premise B. The regional quality management program is independent of the HIPC.
Rationale: Although placing the State Quality Program in the HIPC is simple and
might reduce administrative overhead, the SQP is a public resource and should
not be controlled by an entity in the health care business. Non-HIPC purchasers,
some of whom may be in direct competition with the HIPC, are unlikely to accept
quality measurement controlled by the HIPC. The HIPC may have strong
financial reasons for not making AHPs with which it contracts look bad (Medicaid
plans often avoid having inexpensive facilities delicensed).
Premise C. The nation's overall quality strategy is best driven by a centrally determined
core list of quality measures and by a technical support program to help plans, providers,
and physicians to learn TQM from working to improve performance on the core
measures. Absent a technical support program, it is unlikely that publishing measures
alone will produce effective quality management
Rationale; Although focusing on a core list means that many kinds of problems
will be missed, experience indicates that looking at a random sample of care is
not fruitful. A core list allows setting priorities for health issues that need
improvement and developing performance measures in a careful, scientifically
valid way. Such a list also allows development of assistance materials from which
providers can not only learn to improve specific areas of performance but also
can leam TQM by example. A core list common to all States is essential to
making States accountable.
Although the market may be able to meet technical assistance needs, all experts
with whom we have spoken supported our judgment that government support is
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essential to get such efforts off the ground and to promote cooperation among
plans and providers. Improvement and TQM demand some understanding of
solutions to poor performance; many institutional providers and physicians appear
to lack this understanding. Example: for years, HCFA published mortality data
that was ignored by most providers; only when technical support was offered did
providers reduce their denial.
Premise D. Plans and consumers should have access to information at the physician/
provider level.
Rationale: Collecting physician/provider level data is burdensome and costly, and
numbers of cases will sometimes be inadequate to provide accurate measurements
in many categories for individual physicians or providers. Nevertheless,
information that allows choice within plans as well as among plans may be critical
to winning the support of many who distrust plans. There is little evidence that
variation among physicians within plans is less than variation between plans. A
number of groups are beginning to publish such information for the fee-forservice sector; by the time reform is in place, a quality program that does not
provide such detail will not meet commonly accepted standards. Information
should only be released where there are enough cases to support validity. It is
also important to realize that many physicians and providers will hate this, and
many plans may oppose a system that leads consumers to shop within the plan.
Premise E. A substantial investment in technology assessment and patient care
guidelines is necessary; without it quality improvement will stagnate and quality
measurement will become mechanical in 3-5 years.
Rationale: Quality measures must rest on carefully-constructed guidelines, and
the current flood of guidelines includes very few that are rigorous enough to
support quality measures. A very large amount of practice variation and
unnecessary cost comes from uncertainty as to what is effective; practice
guidelines based on good technology assessments are critical to improved care
and cost containment in areas of uncertainty. Quality measures are likely to prod
plans and providers to vigorous action to correcte deficiencies. As a result, the
original measures will become unrepresentative of typical plan/provider
performance in a few years. A steady stream of new measures is needed to keep
the system working.
On the other hand, very large investments have produced very small numbers of
guidelines, and the effect of those on practice is uncertain. Practice guidelines
can be produced with little investment by professional groups, and, despite
charges of conflict of interest, the major limitation of guidelines developed by
professional groups is usually the absence of underlying evaluation research rather
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than limited skill in the guideline writers.
Premise F. Information systems will become increasingly capable of generating quality
data for measures and for the use of providers and physicians, moving to a fully
computerized patient record in 10-15 years. Initial assumed capability: hospitalizaiton
data, problem list, and either abstractable record or complete procedure file.
Rationale. The data capability assumed for implementation of the quality
management system is a minimum for running an internal quality management
system, and most plans that do not have such capability are already working to
develop it for internal reasons or to satisfy other external customers. The
assumption of a steadily improving information system is consistent with current
trends and allows us to plan for quality measures in a few years that would be too
burdensome to collect today.
However, many IPA model systems that capitate their primary care provider have
not solved the problem of reliable encounter reporting and therefore cannot
generate reliable problem lists; compiling an abstractable record is burdensome
for them because their services occur at many sites.
Premise G. A refocused licensure program is necessary for consumer protection.
Rationale: Although licensure and certification are often intrusive and focus on
trivial issues, they also serve important functions:
Medicare certification requirements are a major route for pulling the plug
on financially terminal hospitals that have ceased to provide basic services.
licensure requirements were necessary to reduce restraint rates in nursing
homes from 39 percent to 21 percent (1990-1992).
licensure requirements were necessary to end warehousing and introduce
active treatment into ICF-MRs.
about 10 percent of mammography facilities were unable to meet basic
Medicare licensure requirements; another 10 percent did not even try.
Consumers believe that these industries would revert to prelicensure status if
licensure were removed; licensure for institutional providers is as basic to
consumer protection as licensing physicians. Licensure requirements should,
however, be refocused on performance measures to eliminate unproductive and
burdensome structure and process requirements, to eliminate most inspections, to
eliminate overlap between State and Federal standards, and to produce maximum
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feasible consistency among States. State licensure function rebuilt on these lines
should replace Medicare/Medicaid processes.
Premise H. The PRO program provides important reassurance to Medicare beneficiaries
and can be a valuable pilot of methods for quality management under Health Care
Reform.
Rationale: The PRO program from 1984 to 1992 saved about enough money to
pay for itself through utilization review, and its impact on overall quality of care
was minimal. Nevertheless, advocates for Medicare beneficiaries such as AARP
often describe its case reviews as a primary defense for beneficiaries against poor
care.
DHHS is rebuilding the PRO program under contracts now coming into effect.
The new program decreases case review by two thirds and eliminates several
abrasive forms of case inspection. A 6 percent case inspection sample has been
retained to reassure consumers and for sentinel effect; it has been redirected to
surveillance of patterns of care and outcomes. The new program is sufficiently
similar to the quality management program proposed for health care reform so
that stepping back from it would raise awkward questions.
Limiting case review entirely to support of TQM activities is an option:
1.
Pro: a) Significant, visible reduction of burden to physicians
b) Symbolically, dramatizes movement away from case inspection.
2.
Con: a) Significant net costs (utilization aspect of case review recoups
perhaps $100,000,000 than it costs - somewhat better estimates to
come) and might be scored as costing more through loss of sentinel
effect.
b) Beneficiary advocates will see this as a step back from beneficiary
protection. Would probably require increased review by carriers
and intermediaries, which physicians would also perceive as "hassle".
Sle-AATOLLXMAHCl
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ATTACHMENT B-revised
ESTIMATE OF FISCAL IMPACT
GOVERNMENT PROGRAM COSTS AND ADMINISTRATIVE BURDEN ON PROVIDERS
($ i n millions)
Current status
National program
Program
0
State program(s)
Mature system
0
Survey/cert
(fed&state)
Burden
Program
Burden
60
121
1
250-500
2
Nursing homes
240
130
240
130
A l l others
110
7
10
0
State licensure a c t i v i t y
40
6
100
6
JCAHO
50
100
50
100
CLIA
50
570
46
3
513
Quality/utilization
Medicare b e n e f i c i a r i e s
PROs
Private sector
Total
250
12
4
0
0
1190
845
0
0
200=
627 1199-1449
1. Burdeo ettimated at $1.00 - $2.00 per penonforthe U.S. Population (see Attachment E)
2. Most survey/cerflioensure is conducted by the States; direct Federal activity is minimal
3. CLIA is financed by user fees, so reducing costs has no net effect on Federal budget. Burden estimates are from unregulated labs
without quality programs, which produces a high estimate.
4. New PRO contracts require 600,000 reviews a year. Assume 10 percent of reviews lead to an invitation to comment addressed to
the hospital/physician and that the toul work in comment is equal to 60 minutes of physician time at $200 per hour.
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5. Assumes that all 30,000,000 Medicare enrollees not currently under managed care will move under plans that use utilization
review. Gxt estimate is based on GAO report that the median utilization reviewfirmhad groas revenues attributable to utilization
review of $1,000,000 and had 130,000 lives covered. This estimate nakts DO allowanct for the physician time involved in respondinf
to utilizatkm review Inqalrie* because no reliable estinates are available, but physician* estimate that the burden of responding to
private utilization review activities ia now much greater than tbe burden of responding to PROs.
S l . . A:\TOLL5BU1-HCB
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�AttaohMnt C (rftviaad)
Budget for th* National Progri
(in millions)
Mmmumwant Davelopnent
1. SpecifIcatlona for calculation and pilot testing
4
2. Guideline Davalopnwint
30
3. Technology Assessments
2
4. Nathodologlnal Studiee
10
5. consumer Survey
2
6. Staffing
1.9
25 PTE
Construction of the National Report
7. Staff 4 PTE
Reviews (optional)
8. Submitted guidelines
9. Submitted utilization protocols
10. Staffing
.25
.4
.4
1
11. Early evaluation of Health care Reform
£ 5 ] Q - 10^5"
subtotal for operations
77
12. Effectiveness Studies
35
TOTAL
112
�Juitification
1. Depending on the meaaurc and the need for eoaplex
H«k
adjustment, development of the calculation specifioatlone and
piloting w i l l coet $SO-300K per mcacure. During the f i r s t 3-5
years of the program, we anticipate developing 20 weaeuree per
year. Since very l i t t l e work has boon done on performance measurA*
related to longter* care or mental health, measures within theee
areas are expected to take nore resources.
2. Bach measure w i l l require an underlying c l i n i c a l practice
guideline that i s of sufficient scientific rigor to command
consensus and serve as the basis for developing the measure
specifications.
A sufficient number of guidelines must be
developed to support 15-20 sound measures.
Development of a
comprehensive, multidisciplinary scientifically rigorous guideline
requires 18-24 months and cost $1 million. Because i t i s prudent
to assume that some of the guidelines w i l l not be adequate to
support a national measure, we budgeting an intensive investment in
their development to assure an adequate supply of guidelines and
measures within the f i r s t few years.
3. Technology assessments that evaluate the effectiveness, safety
and cost effectiveness of medical treatments and technologies, like
practice guidelines must forma the foundation of any measures
selected. We anticipate that most of the measures selected w i l l
require one or more technology assessment. They w i l l range from
narrow assessment of particular devices( insulin pumps) to
evaluations of broader categories of technology ( laproscopic
surgery). Depending on the scope these studies cost $50K- $150K to
complete.
4. Using performance measures to improve quality i s common in many
industries, but i s new in health care. The techniques are
rudimentary at Pest. Therefore i t i s essential to make an onooing
investment in understanding how to best measure performance within
this rapidly changina industry including the most effective
measures to use, techniques for adjusting measures for severity of
illness
and pre-existing conditions, and effective ways to
disseminate information that w i l l improve performance. These
studies w i l l have annual costs of 300K-500K each.
5. The consumer survey w i l l be an independent tool within the
proposed quality management system and i s c r i t i c a l fur assuring
accountability of health care reform . As i t evolves, increasing
sophisticated questions on satisfaction, access, and outcomes of
care are to be incorporated. These questions must be developed and
pilot tested. Further, the consumer survey must be culturally
sensitive, reliable in multiple languages and potentially
administered using multiple formats (eg. in person interview,
�telephone survey and paper questionnaire). The estimate i s based on
development oosts for questionnaires of similar length and
oomplaxity as that envisioned.
6. This represents total staffing requirements. Some uf these staff
will be assigned to the advisory committee, but the majority w i l l
work within existing agencies to implement the plan. The total
number i s based on the following assumptions .5-.7S PTE are
required to oversee the production of a guideline: 6-10 PTE will be
required to write the specifications for measures and provide
technical assistanoo to states, 4-5 staff FTE w i l l be required to
oversee research contracts.
7. Producing the National report card and report to Congress w i l l
require analysis of data presented on state report cards,
purchasing cooperative report cards and consumer surveys. Since
these w i l l be secondary analyses, this w i l l require 4 PTE.
8. and 9. Review of guidelines and utilization management protocols
w i l l be accomplished using a peer- review process similar to that
used by the Public Health Service. A panel of reviewers w i l l
examine submitted guidelines and protocols for scientific rigor.
The panels will meet several times a year and review 100
submissions each time. He have budgeted for the review of 1200
submissions each year. The costs are based on current costs to run
peer review panels.
10. Each panel will require 2 PTE to organize the review process,
summarize the reviews and communicate with those making
submissions.
11. Since i t will take several years for the routine reporting
mechanisms to provide adequate data on which to judge the effects
of health care reform, an early population based study i s planned.
The budget assumes a 15,000 household survey, two interviews - one
baseline and a follow up after reform and oversampling of certain
subpopulations such as families with children and the poor. In
order to adequately oversample rural populations and those with
common c l i n i c a l conditions an additional $10 million dollars w i l l
be required*
12. In the f i r s t year, $15 million will be budgeted for c l i n i c a l
t r i a l s to compare the effectiveness of specific therapies to one
another directly. $10 million i s budgeted to fund projects similar
to PORTs - ffctient Outcome Research Teams, and $10 million i s
budgeted to fund 20-30 smaller projects on priority topics. In
order to add new projects to these multi-year projects, $50
million, $65 million, $80 million, and $95 million are budgeted for
PY 02-05 respectively.
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ATTACHMENT D-revised
COST ESTIMATE FOR STATE QUALITY PROGRAMS
I . Assumptions. We assume an average State w i t h 5,000,000
people. We assume t h a t these i n d i v i d u a l s are e n r o l l e d i n 50
d i f f e r e n t plans and there are 120 h o s p i t a l s and 10000 physicians.
(Does not include any l i c e n s u r e f u n c t i o n and assumes no a b i l i t y
t o review records i n a systematic way.) Assume s a l a r i e s as
f o l l o w s w i t h 100% overhead (include budget, a d m i n i s t r a t i o n , e t c ) :
Program d i r e c t o r (MD)
$120,000
Physician
$100,000
Analyst/investigator
$45,000
Nurse
$35,000
Secretary
$25,000
Clerk
$20,000
I I . Contracts program a c t i v i t i e s .
A.
Educate purchasers.
Educate purchasers regarding
measures, data c o l l e c t i o n , and i n t e r p r e t a t i o n o f
i n f o r m a t i o n contained i n the r e p o r t cards.
1 physician program d i r e c t o r , 1 s e c r e t a r y ,
assume m a t e r i a l s provided by n a t i o n a l program.
$145,000
B.
Education regarding data c o l l e c t i o n . Educate plans,
p r o v i d e r s , and physicians regarding data requirement,
provide t e c h n i c a l assistance regarding data c o l l e c t i o n ,
a u d i t accuracy o f data c o l l e c t i o n , receive data,
organize, forward t o HCFA.
1 senior analyst, 2 analysts, 4 i n s t r u c t o r s , 2
a u d i t o r s , 1 ADP s t a f f , 1 secretary
$430,000
C.
Advisory committees on measures. Includes support o f
advisory committee f o r each o f 20 core measures, which
w i l l meet x4 per year t o consider problems, a s s i s t i n
i n t e r p r e t i n g r e s u l t s , suggest improvement s t r a t e g i e s .
Committees unpaid but c h a i r w i l l be paid f o r p a r t - t i m e
work.
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1 senior analyst, 1 secretary, 1 FTE physician
chair
$185,000
D.
Analyze data. Collate and analyze data, prepare and
discuss report card with plans, providers, and
physicians, publish report card, explain report card to
plans, physicians, providers, and public.
1 senior analyst, 1 analyst, 1 clerk,
ADP support
$155,000
publication and dissemination
E.
$30,000
Disclosure information.
Receive and review disclosure
information from plans other than report card measures
(includes u t i l i z a t i o n control materials, other material
facts regarding plan, proposed enrollment information,
advertising).
2 analysts
F.
$90,000
Conduct consumer survey.
1 senior analyst, 1 clerk: assumes high quality
basic work from national program.
$160,000
survey contract (300 enrollees per plan, 50 plans,
15,000 surveys @$25)
$375,000
G.
Grievance appeals. Provide a mechanism f o r appeal of
grievances not resolved a t the purchasing cooperative
level.
4 s t a f f (3 ALJ, 3 i n v e s t i g a t o r s , 3 c l e r k )
H.
$390,000
Plan compliance w i t h c o n d i t i o n s of p a r t i c i p a t i o n .
Conduct surveys every 2 years of 50 plans
3 surveyors § 50,000 plus t r a v e l
§40,000
$150,000
$40,000
I.
Data processing services c o n t r a c t
J• D i r e c t personnel
K. Non-personnel
$200,000
$1,705,000
$645,000
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L . I n d i r e c t c o s t s (equal to d i r e c t )
$1,705,000
M. Estimate f o r t y p i c a l S t a t e .
$4,055,000
N. Estimate f o r 50 S t a t e s .
$202,750,000
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I I I . Grants program activities
A.
Develop local plan measures. Develop 10 locallyappropriate quality measures for collection by plan.
Committee for each measure; members voluntary, chair
receives honorarium because of management time, each
committee meets x6 per year, staff time of 1 week
senior analyst, 1 week clerical support per meeting,
piloting costs
1 senior analyst, 1 c l e r i c a l , 1 physician $245,000
2 nurses
B.
Develop local consumer survey questions.
Local advisory group, unpaid.
Piloting costs.
1 senior analyst
piloting
C.
$60,000
$20,000
Provide technical assistance to plans, providers, and
physicians in improving performance.
8 staff (2 physicians, 4 nurses/analysts, 1 allied
health professional, 1 biostatistician, 1 clerk)
$540,000
D. Direct personnel
E. Non-personnel
F. Indirect costs (equal to direct)
G. Estimate for typical State.
H. Estimate for 50 States.
$845,000
$20,000
$845,000
$1,710,000
$85,500,000
ttl«-A;\TOLL5BUlJlCR
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ATTACHMENT E
BURDEN ESTIMATE FOR R P R CARD
EOT
The attached spreadsheet provides estimates o f the burden i n
hours and cost i n d o l l a r s t o measure q u a l i t y o f care using 13
measures. These estimates r e s t on a s e r i e s o f assumptions and
are intended t o provide comparisons between costs w i t h and
without an encounter data system and between costs when
measurements are made only a t the plan l e v e l and when they are
made a t the physician/provider l e v e l .
I . Assumptions.
A. A l l pavers.
A l l Americans are covered (250,000,000)
B. Average plan size. Average h e a l t h plan enrollment i s
100,000 (assumes t h a t l a r g e r plans w i l l be evaluated a t the l o c a l
u n i t l e v e l r a t h e r than as a n a t i o n a l system); t h a t i s , there w i l l
be 2,500 u n i t s o f comparison a t the plan l e v e l .
C. Average p a t i e n t load. The average primary care physician
has 1000 p a t i e n t s , a c t i v e and i n a c t i v e .
D. Plan models. S t a f f model plans (those whose physicians
are employees a t c e n t r a l s i t e s ) w i l l not have encounter data; IPA
models (those whose primary care providers are c a p i t a t e d b u t
whose other physicians are f e e - f o r - s e r v i c e ) w i l l have encounter
data except f o r a c a p i t a t e d primary care p r o v i d e r f o r each user;
indemnity models ( a l l of whose physicians are c a p i t a t e d ) w i l l
have encounter data. A l l plans keep a s i n g l e c e n t r a l record
( s t a f f model) or can i d e n t i f y a primary care physician f o r each
e n r o l l e e (IPA model) or have encounter data (indemnity model).
E. D i s t r i b u t i o n among plan models. We f u r t h e r assume t h a t
enrollment w i l l be d i s t r i b u t e d as f o l l o w s : S t a f f models 15%
(37,500,000), IPA models 45% (112,500,000), indemnity models 40%
(100,000,000).
F. S t a t i s t i c a l power. We cost a sample o f 100 per plan o r
per p r o v i d e r . This w i l l mean t h a t i f 55 percent performance i s
reported f o r a sample from one plan and 45 percent f o r a sample
from another, the consumer can be 90 percent c o n f i d e n t t h a t t h e
performance o f the former plan i s b e t t e r than t h a t o f the l a t t e r
plan regarding t h i s measure f o r a l l p a t i e n t s i t t r e a t s , should be
b e t t e r than the performance o f the l a t t e r i n 90 percent o f
comparisons. For outcomes o f i n p a t i e n t care, we do not have t h e
data necessary t o c a l c u l a t e power a t t h i s time but have assumed a
sample o f 100.
G. Cost o f data svstem. To c a l c u l a t e the measures a plan
would need an enrollment system and e i t h e r an encounter system o r
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an independently maintained, automated problem l i s t . We do not
c a l c u l a t e the cost o f e i t h e r because an encounter system i s being
proposed by others f o r system reasons and a problem l i s t i s a
standard o f care according t o most a c c r e d i t i n g groups. I f a
problem l i s t i s maintained and must be automated f o r the sole
purpose o f c a l c u l a t i n g measures then there would be an
incremental cost t o copy the l i s t from the medical record and
enter i t once a year; i n p r a c t i c e , almost a l l plans i n d i c a t e t h a t
they would pursue less cumbersome s t r a e g i e s t h a t made the l i s t
more g e n e r a l l y u s e f u l t o t h e i r management.
We also assume t h a t each plan w i l l r o u t i n e l y receive f o r account i n g and c o n t r o l purposes h o s p i t a l discharge i n f o r m a t i o n eq u i v a l e n t t o the UB-82, which h o s p i t a l s provide t o a l l payers a t
present.
CONCLUSIONS. For the 12 q u a l i t y measures, the average cost per
e n r o l l e e t o c o l l e c t and submit p h y s i c i a n - l e v e l data i s no more
than $1.10 per e n r o l l e e or $0.09 per measure per e n r o l l e e . This
suggests a cost under $2.00 f o r 20 comparable measures. This
estimate assumes t h a t s t a f f and IPA plans do not have encounter
data systems; costs are less than $1.00 per e n r o l l e e i f encounter
data systems are present.
A comparison.
For a method t h a t would include the four most
expensive measures, Cleveland i s paying about $0.35 per e n r o l l e e
for data r e l a t i n g t o a l l e n r o l l e e s (not j u s t a sample). This
suggests t h a t our estimates are high.
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ESTIMATED H U S OF BURDEN F R QUALITY MEASURES
OR
O
ENCT M
O
MEASURE D T INFO
AA
STAFF
Train
Sanple Collect
Review
(per case Total
IPA
Train
Sanple Collect
& Review
(per case
Total
INDEMNITY
Train Sanple Collect
1 Review
(per case Total
APPT WAIT
20
30
20
30
0.25
0.25
0.25
0.25
53
163
49
159
20
30
20
30
4
4
4
4
0.5
0.5
0.5
0.5
74
284
74
284
20
30
20
30
4
4
4
4
0.5
0.5
0.5
0.5
74
284
74
264
20
20
20
20
0.16
0.16
20*
20*
40
1624
44
44
20
20
20
20
4
4
4
4
0.16
0.16
20
20
40
1624
44
44
20
20
20
20
4
4
4
4
20
20
20
20
44
44
44
44
20
30
20
30
0.16
0.16
20*
20*
40
114
44
54
20
30
20
30
4
4
4
4
0.16
0.16
20
20
40
1634
44
54
20
30
20
30
4
4
4
4
20
20
20
20
44
54
44
54
20
30
20
30
20*
20*
20*
20*
44
54
44
54
20
30
20
30
4
4
4
4
20
20
20
20
44
54
44
54
20
30
20
30
4
4
4
4
20
20
20
20
44
54
44
54
20
30
20
30
0.25
0.25
20*
20*
49
2534
44
54
20
30
20
30
4
4
4
4
0.25
0.25
20
20
49
2534
44
54
20
30
20
30
4
4
4
4
20
20
20
20
44
54
44
54
20
30
20
30
0.2
0.2
20*
20*
44
2034
44
54
20
30
20
30
4
4
4
4
0.2
0.2
20
20
44
2034
44
54
20
30
20
30
4
4
4
4
20
20
20
20
44
54
44
54
20
30
20
30
0.16
0.16
20*
20*
40
1634
44
54
20
30
20
30
4
4
4
4
20
20
20
20
44
54
44
54
20
30
20
30
4
4
4
4
20
20
20
20
44
54
44
54
20
30
20
30
0.2
0.2
20*
20*
44
2034
44
54
20
30
20
30
4
4
4
4
20
20
20
20
44
54
44
54
20
30
20
30
4
4
4
4
20
20
20
20
44
54
44
54
PCT USERS
CARD CONS
EARLY
PRENATAL
t
C-SECTION
RATES
IWftJNIZE
RATES
(CHILD)
IMMUNIZE
RATES
(ADULT)
MMOR
ANC
RATES
DIABETICS
UITH >3
VISITS
LIMINARY STAFF WORKING PAPER FOR ILLUSTRATIVE PURPOSES ONLY
�FOR OFFICIAL USE ONL1
17, 1993
ESTIMATED H U SO B R E F R QUALITY M A U E
OR F UDN O
ESRS
EC M
NT O
M A U E DATA INFO
ESR
SURVIVAL
AFTER Ml
N
N
Y
Y
SURVIVAL
AFTER C A N
V
N
Y
Y
SURVIVAL
AFTER C F N
H
N
Y
Y
PCT LOU
BIRTHUGHT N
N
Y
Y
P T PTS
C
UITH
N
BDOE
ESRS N
Y
IN NHs
Y
TOTALS
page 4
STAFF
IPA
Train Saaple Collect
Train Sample Collect
t Review
(per case Total & Review
(per case Total
1DM T
NEN Y
Train SwpUi
Collect
t Review
(per case Total
N
Y
N
Y
120
130
120
130
1
1
1
1
224
634
224
634
120
130
120
130
4
4
4
4
1
1
1
1
224
634
224
634
120
130
120
130
4
4
4
4
i
1
1
i
224
634
224
634
N
Y
N
Y
120
130
120
130
1
1
1
1
224
634
224
634
120
130
120
130
4
4
4
4
1
1
1
224
634
224
634
120
130
120
130
4
4
4
4
i
i
1
1
224
634
224
634
N
Y
N
Y
120
130
120
130
1
1
1
1
224
634
224
634
120
130
120
130
4
4
4
4
1
1
1
1
224
634
224
634
120
130
120
130
4
4
4
4
1
1
1
1
224
634
224
634
N
Y
N
Y
20
30
20
30
20*
20*
20*
20«
44
54
44
54
20
30
20
30
4
4
4
4
20
20
20
20
44
54
44
54
20
30
20
30
4
4
4
4
20
20
20
20
44
54
44
54
N
Y
N
Y
20
30
20
30
20*
20*
20*
20*
44
54
44
54
20
30
20
30
4
4
4
4
20
20
20
20
44
54
44
54
20
30
20
30
4
4
4
4
20
20
20
20
44
54
44
54
HUS
OR
1030
10053
1029
2429
DLAS (ERLE
OLR /NOLE
$20,600
S . 21
O
S201.060 S2.01
$20,580
$0.21
$48,580
$0.49
HUS D L A S SERLE
OR
OLR /NOLE
1055 $21,100
$0.21
6614 $132,280
$1.32
1054 $21,080
$0.21
2554 $51,080
$0.51
U I H E A E A E F R P O I E - E E D T W T O T E C U T R D T S S E (N Y) $1.10.
E G T O VRG O R V D R L V L A A IHU NONE AA YTM
Bk-A:\TOLLJBU3HCIl
PRELIMINARY STAFF WORKING PAPER FOR ILLUSTRATIVE PURPOSES ONLY
HUS
OR
1054
2554
1054
2554
DLAS
OLR
$21,080
$51,080
$21,080
$51,080
$ERLE
/NOLE
$0.21
$0.51
$0.21
$0.51
�FOR O F F ^ f e | L USE ONLY
ILLUSTRATIVE EXAMPLES OF PO^HBLE QUALITY MEASURES — page 1
FIRST TWOYEARS OF MEASUREMENT
D T REQUIREMENTS
AA
(see explanatory notes at end)
INFORMATION REQUIRED
* MEASURE
Denominator
definition
Nuaerator data
Cardiology visits
Ophthalmology
visits.
2. Percent of
women getting
prenatal care in
first trimester
3. Pet of child
enrollees 2-5 with
complete immunizations
4. Pet of 9 enrollees > 50yrs
getting mammograms
Sample size
(denominator)
HS/
OP
ENROLL
DT
AA
Days from referral
to visit (medical
record)
100 visits
no
Uomen enrolled 9
months prior to
delivery
Evidence of
prenatal visits
all deliveries
Child enrollees
enrolled 6 months
prior to audit
Evidence of immunization (usually medical
record)
9s >50 yrs old
enrolled for full
year
PROS
LIST
CLINICAL INTERPRETATION
USE IN
CURRENT
SYSTEMS
ENCOUNTER D T
AA
ALWAYS
FOR M
O
yes
no
no
yes
no
yes
yes
100 enrollees
no
no
no
yes
Evidence of m m
amography
(service file or
medical record)
100 enrollees
no
no
no
yes
Pts under 18 with
diagnosis of
asthma
AU admissions
with principal
diagnosis of
asthma
100 patients
under 18 with
diagnosis of
asthma
yes
yes
no
no
fewer is better; hospitalizations for
yes
pediatric asthma can be minimized by
accessible, appropriate ambulatory care;
6. Rate of Emergency room visits
for pediatric
asthma
Pts under 18 with
diagnosis of
asthma
emergency room
visits with first
diagnosis asthma
100 pts under
18 with diagnosis of
asthma
no
yes
and
chart
review
no
yes
fewer is better; hospitalizations for
yes
pediatric asthma can be minimized by
accessible, appropriate anfculatory care;
7. Rate of emergency room visits
AU enrollees
emergency room
visits
100 enrollees
no
no
no
yes
fewer is better; emergency room visits
often indicate barriers to routine or
semi-urgent care
8. Non-user rate
9. Hospital acta,
rate for attempted
suicide
APPROPRIATENESS
All enrollees
Pts with no visits
100 enrollees
yes
no
no
yes
non-use indicate access barriers
yes
All enrollees
hospitalizations
with code for attempted suicide
all enrollees
yes
yes
no
yes
rates by whether psychiatric problem is
established indicate access barrier or
poor results of treatment
yes
10. Percent of
diabetics having
HgbAIC
Diabetics
enrolled for full
year
Persons receiving
test
100 diabetic
patients
no
yea
and
chart
review
no
yes
more is better; a preferred test for
measuring diabetic control; control is
firmly associated with fewer
conpl ications of diabetes
yes
ACCESS
1. Clinic appt
waiting time: cardiology, ophthalmology
1 5. Rate of
1
hospitalization
for pediatric
asthma
I
shorter is better; waits for specialty
not
clinic appointments is limits access to known
care; waits for urgent conditions are a
special concern
higher rate is better; early and regular yes
prenatal care is associated with better
pregnancy outcomes
higher rate is better; completeness of
yes
ionunization among enrollees indicates
how accessible care is and how much the
clinic reaches out to nonusers
more is better; mamnography is effective yes
in reducing death rate from breast cancer; completeness in enrollees indicates
how accessible care is and how much the
clinic reaches out to nonusers
E L I INARY STAFF WORKING PAI R FOR ILLUSTRATIVE PURPOSES ONLY
yes
'|
�FOR OFFICIAL USE ONLY
ILLUSTRATIVE EXAMPLES OF POSSIBLE QUALITY MEASURES —
INFORMATION REQUIRED
1MEASURE
Denominator
definition
Nuaerator data
D T REQUIREMENTS
AA
(see explanatory notes at end)
Sample size
(denominator)
HOSP/
ENROLL
DT
AA
no
PROB
LIST
page 2
USE IN
CURRENT
SYSTEMS
CLINICAL INTERPRETATION
ENCOUNTER D T
AA
ALWAYS
FOR M
D
yes
and
chart
review
no
yes
Diabetics enrolled
for full year with
any abnormal
HgbAIC
Nurtwr of visits
100 diabetic
patients
12. Pet of
diabetic patients
having funduscopy
Diabetics
enrolled for full
year
Evidence of funduscopy from
medical record
100 diabetic
patients
no
yes
and
chart
review
no
no
13. Pet of fenale
users > 50yrs old
getting mamaograms
Female users > 50
yrs old enrolled
for full year
Those who had a
maomogram
100 female
users > 50yrs
no
no
no
yes
more is better; shown to be effective in yes
reducing death rate from breast cancer;
rate in users indicates how we11 clinic
staff follow accepted principles of
prevention
all facilities
used
no
no
no
no
more is better; low surgical vol une for yes
this procedure is associated with higher
rates of complications and mortality
H. Annual vol une
of cardiac bypass
procedures in each
plan facility
more is better; unless a test indicates
diabetes is in control, patient should
be seen regularly to improve control
because control is firmly associated
with fewer complications
more is better; examination of eye i s
essential to detect early signs of
diabetic complications, which can be
treated effectively but lead to
blindness without complications
yea
11. Pet of
diabetics uith >3
OPV visits/year
yes
15. Pet of child
users uith
complete immunizations
Child users enrolled 6 months
prior to audit
Evidence of
ionunization
100 users
no
no
no
yes
more is better; completeness of im- .
munization among users indicates how
well clinic staff follow accepted principles of prevention
16. Pet of hypertensive pts uith 2
visits/yr
Pts with diagnosis
of hypertension
Pts with 2 or more
primary care
visits in year
100 hypertensive patients
no
yes
no
yes
more is better; this is the miniuja
not
nuaber of visits to establish that a
known
patient with hypertension is maintaining
control
17. Inmjnization
rates for adults
Enrollees over 60
and with high risk
problems
Pts immunized for
pneuaococcus and
(maybe) influenza
100 users over
60
no
yes
no
yes
more is better; pneunococcal and
probably influenza vaccines reduce
morbidity and mortality in older and
high risk persons
Uomen over 20
years of age
Pap smear status
consisten with
guideline
100 female
users > 20 yrs
of age
no
no
no
yes
more is better; pap smears lead to early yes
detection of cervical cancer
\lamn delivering
Caesarean
deliveries
all deliveries
yes
no
no
no
exact correct rate ur^iroven, but rates
above 20-25 widely considered too high
and below 10 probably too tow
primary adaissions
for heart attack
date of death
(enrollment file)
risk data from
special abstract
100 hospital
yes
admissions for
heart attack
no
no
no
there are nunerous well-established
_
steps hospitals can take to reduce risk
of death for patients with heart attack;
intensive and routine care are i s s u e ^ ^
18. Pap smears
II consistent uith
NCI guideline
II 19. Caesarian sec1 tion rates
1
yes
yes
yes
OUTCOMES
20. risk-adjusted
ll 30-day survival
1 after heart at1
II tack
PRELIMINARY STAFF WORKING PA
R ILLUSTRATIVE PURPOSES C LY
9
�FOR
OFF|^AL USE ONLY
ILLUSTRATIVE EXAMPLES OF
IT™ MAUE
ESR
POSSBLE
INFORMATION REQUIRED
Denominator
definition
Nuaerator data
QUALITY MEASURES —
DATA REQUIREMENTS
(see explanatory notes at end)
Sanple size
(denominator)
HOSP/
ENROLL
DT
AA
PROB
LIST
page 3
CLINICAL INTERPRETATION
USE IN
CURRENT
SYSTEMS
ENCOUNTER D T
AA
ALWAYS
FOR HO
patients adaitted for stroke are at high yes
risk; Rand has shown that better care
for patients with stroke leads to better
outcomes; intensive and routine care are
issues
patients acfcnitted for heart failure are yes
at high risk for death before and after
discharge; Rand has shown that better
care for patients with failure leads to
better outcomes; intensive and routine
care are issues
21. risk-adjusted
30-day survival
after stroke adnission
primary adaiaaiona
for stroke
date of death
(enrollment file)
risk data from
special abstract
100
yes
no
no
no
22. risk-adjusted
30-day survival
after heart
failure acta
primary adaissions
for congestive
heart failure
date of death
(enrollment file)
risk data from
special abstract
100
yes
no
no
no
23. risk-adjusted
30-day survival
after pneuaonia
adn
24. risk-adjusted
30-day mortality
after bypass
surgery
primary atferissions
for pneumonia
date of death
(enrollment file)
risk data by
special abstract
date of death;
risk data by
special abstract
100
yes
no
no
no
Rand has shown that better care for
yes
patients with pneunonia leads to better
outcomes; intensive and routine care are
issues
100
yes
no
no
no
experience in New York State indicates
yes
that hospitals can reduce high mortality
rates for this condition
25. pet of
patients able to
ualk 6 months
after hip surg.
hip replacement
surgery
ambulation status
from follow-up
phone survey; risk
adjusters
100
yes
no
no
no
angulation status is influenced by postoperative and post-discharge
rehabilitation services
not
known
26. Rate of nursing home stays >6
months after hip
fracture
27. Percent of low
birthweight babies
Pts discharged
from hospital with
diagnosia of hip
fracture
pts in nursing
home 6 months
after admission
100
yes
no
no
no
less is better; patients in a nursing
home 6 months after hospitalization
generally never walk again
not
known
Deliveries
weights below 2500
B. 1500 g
all deliveries
yes
no
no
no
low birthweight is an adverse outcome
strongly associated with future
morbidity and mortality
yes
28. Bedsore rates
for bedridden
population
Bedridden pts in
nursing home or
hoaw health care
Number of pts with
bedsores
100 pts in
nursing home
100 on home
care
yes
no
no
no
bedsores are almost entirely avoidable
with appropriate care
yes
29. Amission rate
following
ambulatory surgery
Pts with selected
types of ambulatory surgery
Hospital adknissions within 24
hours
100 patients
with each of 6
procedures
yes
no
no
no
adnission within 24 hours of anbulatory
surgery almost always indicates an
complication
yes
SATISFACTION
30. Disenrollment
rate
Enrollees
enrollment file or
survey of enrollees
all enrollees
bypass surgeries
PRELIMINARY STAFF WORKING PAI
yes
R FOR
ILLUSTRATIVE PURPOSES ONLY
�FOR OFFICIAL USE ONLY
ILLUSTRATIVE EXAMPLES OF POSSIBLE QUALITY MEASURES —
INFORMATION REQUIRED
MEASURE
(see
Denominator
definition
Nuaerator data
Sanple size
(denominator)
31. Pet of pts
using out-of-plan
services at own
expense
Enrollees
survey or a l l payer billing
system
Enrollees
average score on
survey
to be
determined
PROS
LIST
CLINICAL INTERPRETATION
USE IN
CURRENT
SYSTEMS
ENCOUNTER DATA
ALWAYS
FOR M
D
to be determined
32. Patient
satisfaction
HOSP/
ENROLL
DT
AA
D T REQUIREMENTS
AA
explanatory notes at end)
page 4
yes
several standardized instruaents are
available for surveying patient
satisfaction
NOTES ON DATA REQUIREMENTS: Data requirements column r e f e r s t o minimum data necessary.
Encounter
data c a n provide a l l t h ^ information i n the problem l i s t .
HOSP/ENROLL DATA r e f e r s t o
information a v a i l a b l e e i t h e r from the plan's enrollment f i l e or from data (UB-82T r o u t i n e l y
f u r n i s h e d by h o s p i t a l s t o payers. fROB LIST r e f e r s t o an c e n t r a l e l e c t r o n i c problem l i s t
maintained by t h e plan f o r each p a t i e n t t h a t i s r e g u l a r l y updated with c l i n i c a l changes.
ENCOUNTER DA^A ALWAYS means t h a t encounter data a r e necessary t o i d e n t i f y c a s e s t o which t h i s
measure a p p l i e s . ENCOUNTER DATA FOR MD means t h a t the burden of r e p o r t i n g performance f o r
i n d i v i d u a l p h y s i c i a n s o r h o s p i t a l s would be very high u n l e s s encounter data were p r e s e n t .
PRELI
INARY STAFF WORKI 5 PAP
R ILLUSTRATIVE PURPOS B 0 LY
�4/7/93
CONSUMER SURVEY
Purpose: To measure l e v e l s of s a t i s f a c t i o n , access, and other
aspects of h e a l t h and health care experienced by consumers
under a reformed health care system.
Proposal:
Survey. Require the NHB/DHHS t o create and maintain a survey
process f o r o b t a i n i n g minimal uniform i n f o r m a t i o n r e f l e c t i n g
consumer experiences w i t h a reformed health care system and
make such information a v a i l a b l e f o r s p e c i f i e d purposes.
Need and f e a s i b i l i t y . Routinely assessing consumer experiences
and s a t i s f a c t i o n ' w i t h i n a reformed health care system i s
e s s e n t i a l because of concerns regarding p o t e n t i a l problems w i t h
access and q u a l i t y under managed care. Proven measures are
a v a i l a b l e t h a t can be applied today as more r e f i n e d measures
are developed f o r f u t u r e use.
Responsibilities.
R e s p o n s i b i l i t i e s of the NHB/DHHS include the f o l l o w i n g :
1) Specify the general dimensions t o be measured, as w e l l
as a few s p e c i f i c , mandated measures i n order t o generate
comparable information f o r i n c l u s i o n i n the n a t i o n a l
"report card."
2) Specify general parameters regarding sample s i z e , t h e
manner i n which samples are t o be drawn, survey
a d m i n i s t r a t i o n , and the coding and processing of uniform
measures. At a minimum, the surveys should be p o p u l a t i o n based and not l i m i t e d t o users of h e a l t h care. The
samples should be generalizable. I n f o r m a t i o n should be
captured about a l l care s e t t i n g s and not j u s t i n p a t i e n t .
3) Specify over-sampling, when appropriate, o f
p o t e n t i a l l y vulnerable populations who may experience
problems w i t h access and q u a l i t y . These may i n c l u d e nonEnglish-speaking people, low-income populations,
t r a d i t i o n a l l y under-served groups ( i n inner c i t i e s and
r u r a l areas), the p h y s i c a l l y and mentally challenged,
persons w i t h AIDS, and d i s e n r o l l e s . Require the
t r a n s l a t i o n of survey questions i n t o languages other than
English and the use of s p e c i a l e f f o r t s t o contact and
include such populations, as appropriate. Specify the use
of s p e c i a l questions o r instruments t o assess experiences
w i t h p a r t i c u l a r types of care, such as long-term or mental
h e a l t h , as appropriate.
�4) Compile uniform data, derived from consumer survey
i n f o r m a t i o n submitted by the SQPs, f o r i n c l u s i o n i n the
n a t i o n a l r e p o r t card.
5) Develop and p i l o t t e s t i n c r e a s i n g l y s o p h i s t i c a t e d
measures o f s a t i s f a c t i o n , access, and outcomes t h a t are
c u l t u r a l l y s e n s i t i v e , r e l i a b l e i n m u l t i p l e languages, and
p o t e n t i a l l y administered using m u l t i p l e formats (in-person
i n t e r v i e w s , telephone surveys, paper q u e s t i o n n a i r e s ) .
6) Maintain a l i b r a r y o f consumer measures and provide
sample measures, advice, and t e c h n i c a l assistance t o SQPs
and h e a l t h plans on request.
R e s p o n s i b i l i t i e s o f the SQPs include the f o l l o w i n g :
1) Conduct consumer surveys and analyze the responses
consistent w i t h NHB/DHHS requirements.
2) Forward t o the NHB/DHHS f o r i n c l u s i o n i n the n a t i o n a l
r e p o r t card the mandated i n f o r m a t i o n on consumer
experiences w i t h i n the plans f o r which the SQP has
responsibility.
3) Augment the minimal set o f questions r e q u i r e d by the
NHB/DHHS w i t h a d d i t i o n a l questions o f s p e c i a l relevance t o
the p a r t i c i p a t i n g h e a l t h plans f o r which the SQP has
r e s p o n s i b i l i t y , o r o f s p e c i a l relevance t o the populations
and geographical areas served by those plans, i n order t o
produce meaningful i n f o r m a t i o n t o f a c i l i t a t e consumer
choice.
4) F a c i l i t a t e the use of such i n f o r m a t i o n a t the l o c a l
and r e g i o n a l l e v e l s through such e f f o r t s as working w i t h
h e a l t h plans t o incorporate consumer r e p o r t s and concerns
i n t o i n t e r n a l q u a l i t y management and improvement
activities.
Dimensions t o be measured. The dimensions t o be considered by
the NHB/DHHS f o r i n c l u s i o n i n minimal, uniform measures and by
the SQPs f o r a d d i t i o n a l measures should include the f o l l o w i n g :
a c c e s s i b i l i t y and a v a i l a b i l i t y o f services and providers
( i n c l u d i n g r e f e r r a l s ) ; whether meaningful choice i s provided
among plans and p r o v i d e r s ; whether p a t i e n t s are informed about
treatment options and allowed t o express t h e i r preferences;
c o n t i n u i t y o f care; communication; i n t e r p e r s o n a l aspects o f
care; outcomes and f u n c t i o n a l s t a t u s f o l l o w i n g r e c e i p t o f
h e a l t h care services; t e c h n i c a l q u a l i t y o f care; time spent
w i t h p r o v i d e r s ; s a t i s f a c t i o n w i t h the range o f services
provided; a v a i l a b i l i t y o f p e r t i n e n t i n f o r m a t i o n ; paperwork
burdens; costs o f care; general measures o f o v e r a l l
s a t i s f a c t i o n ; and the l i k e l i h o o d o f (and reasons f o r )
disenrollment. The content and focus o f mandated questions
�should change over time, j u s t as measures of q u a l i t y w i l l
change.
Reporting Requirements. The SQP s h a l l r e p o r t t o the NHB/DHHS
on the minimal, mandated s a t i s f a c t i o n measures at l e a s t
annually, as s p e c i f i e d by the NHB/DHHS.
Uses of the Information. Consumer-reported i n f o r m a t i o n s h a l l
be used by the NHB/DHHS i n compiling annual r e p o r t cards,
reports t o Congress, and such other r e p o r t s as the NHB/DHHS may
issue. Such i n f o r m a t i o n s h a l l be used by the SQPs i n
p u b l i c a t i o n s and other a c t i v i t i e s intended t o f a c i l i t a t e
consumer choice among competing h e a l t h plans, and i n t e c h n i c a l
assistance and other a c t i v i t i e s intended t o f a c i l i t a t e i n t e r n a l
q u a l i t y management and improvement w i t h i n h e a l t h plans. The
plans themselves may have s i m i l a r uses f o r such i n f o r m a t i o n ;
however, i f plans gather and p u b l i c i z e any consumer-reported
i n f o r m a t i o n other than t h a t which i s authorized by the SQP, i t
must be so i d e n t i f i e d .
Funding.
The cost of conducting the survey should be included i n the
annual budget of the SQPs.
There i s authorized an a p p r o p r i a t i o n of $2 m i l l i o n f o r
measurement development by the NHB/DHHS.
NOTE: For cost estimates: Depending on the types of analyses
planned and the degree of p r e c i s i o n desired, most consumer
surveys include samples i n the range of 150-400 people. The
cost per completed questionnaire ranges from $10-20, depending
on the method of a d m i n i s t r a t i o n , extent of follow-up of nonrespondents, amount of analyses performed, e t c .
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1
£.fcVl " b O
Uncertainty in Health Care Contributes Significantly to Uncontrolled Rise in Cost
Executive Summary
The principle causes of the acceleratingrisein health care cost are
(1) lack of a clear definition of the product of the health care enterprise, and
(2) uncertainty about which treatments work in practice and which work best.
Rising administrative costs for oversight resultfrommisguided attempts to control health care
costs without addressing the underlying causes.
The lack of a clear definition of the product of the health care enterprise has provided a context in
which measurement and management toward greater efficiency has not been possible. The lack
of a clear definition of the product of the health care enterprise and the large degree of uncertainty
in heakh care delivery have precluded consumersfrombeing able to recognize and demand best
value. Insufficient consumer protection and informed consent standards have resulted in ongoing
failure to empower consumers to make best value comparisons, recognize the degree of
uncertainty in health care, and participate in their own treatment decision-making.
Recommendations
Establish that the goal of the health care enterprise is to maintain all Americans in maximum
possible health, and restore each individual to health when needed. The goals of health care
reform are to assure that all needed care is available to all Americans, and to assure that this care
is delivered at the lowest possible cost, so that Americans can better afford other necessities such
as food, clothing, and shelter.
Empower all consumers as partners in decisions about their own health through higher standards
of full disclosure and informed consent, with emphasis on portrayal of the extent of uncertainty in
health care.
Put in place those processes necessary to assess all current and future treatments for
effectiveness in actual practice and efficiency compared other treatments in achieving the goals
of the health care enterprise.
Disseminate the results of these assessments to consumers and providers so that the
information can be used during decision-making by comsumers and providers.
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"Technology in most other sectors. . . is associated with decreasing cost or the capacity to
meet certain needs with fewer resources. . . [However,] we count the cost of the new NMR facility
but not the benefit to patients of the improved technology. If the medical sector is to attract more
resources for the continued development and introduction of new technologies, many of which
may reduce cost, we must develop a betterframeworkfor discussing this issue.... Contemporary
public policy discussions indicate that society is no longer willing to passively allocate as much of
its resources as the medical sector deems necessary to fulfill its function. Instead, society is
asking for some accounting of cost and benefits We may even need to evolve a new
understanding of what is meant by health and quality care. Important ethical as well as
economic and medical issues are involved. In short, we not only want to look at cost/benefit
ratios, but also to understand better what is meant by benefits ...The real issues, however, are not
cost containment, . . .the real issues consist in arriving at a better understanding of what
health means and a more efficient and appropriate use of our national resources." (Harold
Shapiro, AJC, 1985).
"...while detached policy analysts mayfindit easy to discourse upon the value of lifefroma safe
distance, no one has yet given the individual physician a publicly sanctioned set of
guidelines under which to make cost-quality tradeoffs at the patient's bedside..." (Uwe Reinhardt,
AJC, 1985).
[Implication for Health Care Reform: Providers and managers cannot guide the
American health care enterprise toward greater production efficiency until the
product of the health care enterprise is clearly defined. Once the product is
defined, progressively more effective and efficient approaches can be devised and
implemented in such a way that information on preferred treatments is available
and used during decision-making by patient and doctor ]
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•
Life expectancy and rising health care costs (Lundberg, JAMA, 1992):
G
o
p
1932 1937 1942 1947 1952 1957 1962 1967 1972 1977 1962 1987 1992
L
i
f
•
E
x
P
•
c
t
n
e
y
60
60-
Pliilllliliilllllll li I
mm^wmmmmmM
wmmmmmmmmmM
1900
1910
1920
1930
1940
1960
1960
1970
1980
1990
Decade of Birth
[Implication for Health Care Reform: While significant advances in life
expectancy occurred in the early part of this decade, rising costs have accelerated
at the end of the decade. This data suggests that Americans are receiving
progressively less value for each dollar invested in the health care enterprise; or
that other measures of the product of the health care enterprise are needed in
addition to life expectancy, in order to manage on a nation-wide basis toward
increasing efficiency in producing that product ]
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1. Only about 20% of "routinely accepted and frequently used" procedures have been tested for
efficacy (Office of Technology Assessment, 1988). "There is a surprising lack of knowledge
about what works in medicine. Many technologies in common use have never been evaluated.
Many that have been evaluated remain of uncertain benefit to large numbers of patients" (GAO,
1992).
2. 25% of all procedures, 25% of admissions, and 40% of medications are of questionable value
or are unnecessary (RAND, 1990).
(Naimark, Medical Device & Diagnostic Industry, Cannon Communications, 1990)
Appropriate Equivocal
Inappropriate
Coronary angiography
74%
8.5%
17.4%
Carotid endarterectomy
35%
32%
32%
UGI Endoscopy
72%
11%
17%
Pacemaker
44%
36%
17%
Categorization of Final Indications for Interventions by Appropriateness (Park, Rand
R-3280-CWF, 1986) (in percent)
Angio Cab CH End CO CE
39
45
67
Inappropriate
14
25
22
25
Equivocal
24
33
33
52
23
37
Appropriate
62
43
22
25
10
Angio=coronary angiography
Cabs= coronary artery bypass surgery,
CH = cholecystectomy
End = upper gastrointestinal endoscopy
€0=fiberopticcolonoscopy
CE = carotid endarterectomy
The impact of presenting relevant information to physicians during decision making has been
studied. A picture is emerging that such presentation is effective in altering utilization. Overall,
charges per admission were shown to be reduced 12.7% (p=0.02) compared to simultaneous
controls. Significant reductions were documented in bed charges, diagnostic test charges, drug
charges, and hospital costs (Tiemey, JAMA, 1993).
[Implication for Health Care Reform: The high percentage of indications for
procedures that are considered equivocal suggests that uncertainty in health care is
a significant problem that can confound judgement of appropriateness by
practitioners and managers. Also, this high level of uncertainty combined with a
fee-for-service context provides the incentive and permissive environment for
uncontrolledrisein utilization and cost. The clarity of the inappropriate cases
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suggests that prartice guidelines based on current knowledge are needed urgently,
and could be immediately useful. Better understanding of the best approaches to
diagnosis and treatment are needed. Substantial control of health care cost can be
achieved by implementing guidelines that emphasize treatments that are already
clearly recognized as appropriate, and discourage those that are equivocal or
inappropriate]
3. Crossover rates in clinical trials for coronary bypass surgery are very high, making
interpretation (for efficacy) controversial (Diamond, Ann Int Med, 1993):
medical
surgical
VA
17%
6
%
ECSS 24%
7
%
CASS 24%
7
%
Crossover rate (in CASS) in the medical group was highly correlated with extent of
coronary artery disease.
Crossover rate (in CASS) in surgical group was highly correlated (inversely) with extent
of coronary artery disease.
The technique to minimize this difficulty is analysis based on treatment assignment (intention to
treat). Such trials aimed at effectiveness require large test populations that are broadly
representative of the population likely to be considered for such treatment in practice.
[Implication for Health Care Reform: technology assessment is critical to
understanding what works; is needed; is expensive; is difficult to do without sound
experimental design including collection of a great deal of patient (test subject)
information over time ]
4. With twelve internists reviewing 675 records, inter-rater reliability was acceptable for overall
quality of care and preventable death in the aggregate, but not for individual records, and not
adequate for such things as timeliness of evaluation, readiness for discharge, appropriateness of
use of ancillary resources (Hayward, AnnlntMed, 1993).
A panel of internists and surgeons reviewed 112 records after classification by the PRO. Panel
found 18% ofrecordsto have quality problems while the PRO found only 6%. PRO failed to
detect 66% of the records the panel felt showed substandard care. In addition, only 33% of the
records the PRO called substandard were judged to be problematic by the panel. Therefore, the
agreement of the panel and the PRO were little better than chance alone would predict (Rubin,
JAMA, 1992).
[Implication for Health Care Reform: Agreement among professionals is poor,
indicating that the level of uncertainty in health care is very high. Therefore,
developing a sufficient understanding of which care is appropriate and which is not
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is key to managing an AHP, so that premiums can be set, planfinancialrisk
quantified, and AHP resources allocated by plan managers to the most effective
and efficient diagnosis and treatment approaches ]
5. US ranks 10th in satisfaction per unit cost even though the use of specialty care is higher in the
US than in the top-ranked country (Netherlands) (Blendon, Health Affairs, 1990).
[Implication for Health Care Reform: we do not understand the optimal mix of
high tech vs low tech treatment to keep patients satisfied. We only think we do, or
use it as an excuse to justify more high-tech intervention, when patient education
alone might do (meaning realistic, detailed "full disclosure" and "informed
consent").]
6. US ranked 6th (out of 7) in health status despite higher use of primary care and some (loose)
control of access to specialty care in the top-ranked country (Netherlands) (Starfield, JAMA,
1991).
[Implication for Health Care Reform: Therightbalance of high tech specialty
care versus low tech primary care is not clear.]
7. Proficiency scores for generalists and specialists within their area of expertise and outside vary
widely. Specialists know their own area better than generalists do, but know other areas much
less well than the generalists. (Rhee, 1975):
high (+50)
low(-50)
specialist
+42 (in specialty)
-39 (out of specialty)
generalist
+20 (in specialty*) -1 l(out of specialty*)
(* specialty for generalist = triage/primary care)
[Implication for Health Care Reform: since 88% of visits are for self-limited
problems, specialists have a significant chance of mismanaging most patient
problems falling outside of their specialty domains, while generalists have a
significant chance of mismanaging the 12% of visits for serious problems that are
beyond their level of expertise. Therefore, practice guidelines are needed for both
generalists and specialists.]
8. 33-64% of patient encounters involve serious errors in diagnosis (Brook, RAND, 1989;
Williamson, QA&UR, 1991; Wu, JAMA, 1991).
[Implication for Health Care Reform: practice guidelines for effective
diagnostic strategies are needed ]
9. Medicare data (1985-88) indicate significant growth in use of advanced imaging (32%),
sonography (25%), endoscopy (17%), and orthopedic procedures (9%) (Berenson, JAMA,
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1992), while other data (Peterson, WJM, 1992) indicate that the most diagnoses (76%) can be
established from the medical history alone, another 12%fromthe physical exam, with only the
last 11% requiring lab tests.
Exercise thallium scintigraphy is an exaple of a high-technology innovation to improve the
diagnosis of coronary artery disease in combination with exercise ECG testing. A review of the
literature found 122 studies relevant to determination of the discriminanat accuracy of exercise
thallium myocardial scintigraphy for the diagnosis and prognosis of patients with known or
suspected coronary artery disease, which reported both test sensitivity and specificity. The
authors conclude that thallium stress testing is useful in diagnosis and prognosis, but add.
"...Because of various shortcomings in the published record, however, the marginal
discriminant accuracy and cost-effectiveness of thallium scintigraphy compared with
conventional clinical assessment and exercise ECG remain controversial." (Kotler TS, Ann
Int Med 1990; 113:684-702)
In addition, to obtain the full value of increasing certainty of this testing, the interpretation of the
results is not simply categorical ("normal", "abnormal", or "borderline"), but in fact continuous on
a spectnim of probability related to either diagnosis or prognosis (Am College Physicians, Ann
Int Med 1990; 113.703-704).
Clinical prediction rules are the subject of analyses published in the medical literature. Prediction
rules could be one important foundation for the development of practice guidelines (Heckerling
PS, Ann Int Med, 1990; 113:664-670). However, there are indications that the impact of rules on
clinical practice is low, with one key reason being that the language of the literature on rule
development is not understood by clinicians generally (Epstein PE, Ann Int Med 1990;
113:646-647). Several additional reasons for this low impact are suggested:
(a) tests are performed for reasons other than clinical (e.g., please the patient) (Brand DA, NEJM,
1982; 306:333-9);
(b) inability or unwillingness of physicians to grasp the quantitative reasoning underlying a
probabilistic model (Detsky AS, J Chronic Dis, 1987; 40:831-6);
(c) least personal discomfort ("chagrin") (Feinstein A, Arch Int Med, 1985; 145:1257-9);
(d) inadequate description in the literature of the clinical impact of use of decision rules (Wasson
JH, NEJM, 1985; 313:793-9).
[Implication for Health Care Reform: given the increasingly broad array of
overlapping tests available, well-studied practice guidelines are needed for
effective and efficient approaches to diagnosis. A certain level of sohpisitication
on the part of the clinician and the patient is required to understand the
implications of the results, especially as related to full disclosure, informed
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consent, and participative decision-making bewteen doctor and patient.]
10. There is significant variation between US and Canada in resource use for health restoration
(Rouleau, NEJM, 1993):
US
Canada
Pts admitted to CCU w MI 35%
51% (pO.001)
similar pts w angiograms
68%
35% (p<0.001)
similar pts w CABG
31%
12%(p<0.001)
mortality
23%
22% (NS)
re-infarction
13%
14% (NS)
angina
27%
33% (p<0.007)
The control of the supply of high-technology treatments in Canada is associated with much lower
rates for CABG than in the US (Anderson, JAMA, 1993):
Rate (per 100K population) (age-adjusted)
Califomia
112.5
New York
88.4
3 Canadian provinces
62.4
There is significant variation in health care cost between US and UK, without evident adverse
health impact and with better access (Grumbach, NEJM, 1993):
US
UK
1990 population(millions)
252
58
% population w no coverage 14
0.
1989 health care cost
%GDP
11.8
5.8
Per capita ($)
2,354
836
% publicly financed 42
87
Life expectancy
women .
78.4
78.3
men , •
71.5
72.6
Infant mortality/1000 live births 10.1
9.2
Annual physician visits/capita 5.3
5.7
GP/general population
1/1769
1/1758
% docs who are generalists 30%*
50-70% (all developed countries)*
(•Schroeder, NEJM, 1993)
In the US fees, price of resources, and the amount of resources to complete a procedure are
higher than Canada. The quantity of services* per capita is on the average lower in the US than
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Canada (even though other studies [see above] show that for specialty procedures this is not
universally true) (Fuch, NEJM, 1990).
1987 Ratio US/Canada
Expenditures/capita 1.75
Fees
2.61
Service*/capita
0.67
Price of resources
1.32
Quantity resource/ 1.98
quantity service
(* Services = all visits, tests, operations, and others services provided by physicians)
Some key features of the Canadian system (Iglehart, NEJM, 1990):
- universal access is provided for all "medically necessary services";
- determination of "medical necessity" is done by the physician;
- there are no upper limits on the provision of care as long as it is deemed medically necessary;
- despite universal coverage, life expectancy varies by income (diflFerence between highest and
lowest: 5.6 yrs for men and 1.9 yrs for women);
- 20-33% of provincial tax revenue goes tofinancinghealth care;
- costs have continued torisedespite attempts at control of technology use:
1977 Ottawa abandons open-ended contribution (equal cost sharing) to provincial plans;
Ottawa's contribution linked to growth in GDP;
Costs haverisenfaster than GDP in 8 of the past 13 years;
1986 Ottawa contribution further reduced to 3 percentage points below GDP increase,
putting the provincial governments at progressively greaterriskfor rising
health care costs;
- hospitals negotiate operating funds with provincial governments annually;
- provincial governments control the difiiision of technology:
- to teachning hospitals only;
- techniques are less available than in the US (per capita) (US/Canada):
MRI units
8/1
lit&otriptors 6/1
best cath labs 3/1
- rationing by inconvenience rather than science-based criteria (at St. Michael's):
1984
1989
number pts on CABG wait list 38
232
waiting time for CABG
3 weeks
4 months
50% physicians have difficulty admitting pts to hospital (bed occupancy =90%);
94% physicians disapprove of provincial gov't handling ofrisingcost problem;
There is slowly growing awareness that appropriateness and efficacy of medical
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interventions will have to be examined.
Geographic variation in payment for physician services across the US is very large with no
evidence of variation in need for service nor outcome (Welch, NEJM, 1993):
mean SD
admission rate/1000
payments/admission
payment s/beneficary
(inpatient)
payment/beneficiary
(outpatient)
payment/beneficiary
(overall)
304 48
$1180 145
$360 81
Coeff
ofvar
15.6
12.3
22.4
min
max
physicians/capita
219 533 NS
$677 $1580 NS
$212 $700 NS
% in prim care
cor coeff (p)
-.11(05)
-.23(001)
-.20(001)
$641
125
19.5
$388 $1388 NS
-.23(001)
$1001 165
16.5
$655
-.27(.001)
$1874 NS
Annual hospital cost for hysterectomy is $5B in the US. Rate of hysterectomy varies 6-fold
across western countries, highest in the US; and varies significantly within the US, highest in the
South and Midwest. Available evidence indictes that professional uncertainty about the
appropriate use of hysterectomy is primary cause of the wide variation in rates. Uncertainty
seems most related to difficulties in diagnosis, lack of information on outcomes and alternatives,
and differences between physician judgement and patient preference (Carlson, NEJM, 1993).
[Implications for Health Care Reform: There is significant variation in the
treatment patterns (utilization) between the US and Canada with little visible
impact of health. There is significant variation in cost of health care between the
US and the UK with no impact on health evident by these measures. While the
ratio of generalists to population is the same for US and UK, the greater
proportion of physicians who are specialists in the US suggests that there is an
excess supply of specialists in the US relative to the actual health care needs of
Americans. These data suggest that specialists (the procedures they perform) in
US add cost out of proportion to the health improvement they provide. High
variation in physician payments (case mix-adjusted) indicates the lack of consensus
among physicians about which services are required. Practice patterns appear to
be best correlated with with the proportion of physicians in primary care versus
specialty care.]
11. In Canada (Ontario) specialized procedures are performed in a relatively small number of
large hospitals, while in the US (Califomia) most community hospitals provide a wide variety of
tertiary care services (Redelmeier, NEJM, 1993):
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- after adjustment for population size (in 1987) US/Canada
- facilities performing open heart surgery: CA/Ontario = 3/1
- facilities w magnetic resonance scanners: CA/Ontario = 5/1
- facilities w extracorporeal lithotriptors. CA/Ontario = 10/1
- lithotriptor treatments/week/facility:
CA/Ontario = 5/50
- 50% CA open-heart programs perform < 200 cases/year
[Implication for Health Care Reform. The US health care industry is in a state
of over-capacity, which adds cost without an equivalent improvement in health of
Americans.]
Uncertainty is expensive: In 1984, for CABG 5% were performed for left main disease to
prolong life; 10% to possibly prolong life in pts w 3-vessel disease and poor ventricular function;
30% for symptoms not relieved by medication; 52% were performed for no clear indications.
CABG in 1984 cost $5B not counting time away from work nor outpatient care costs (see
Harrison, D, AmJCard, 1985 (Preston, Atlantic Monthly, 1984))
"...Bostonians receive almost twice as much hospital care and at twice the cost per capita as do
New Havenites. Yet there is no evidence that the people of Boston need more or that they live
longer or are happier because they receive more. A $300 million annual savings could result if the
Boston figures were reduced to the New Haven level..." (Koop, Laszewski, Wennberg,
Washington Post, 19 Feb 1992).
Medical uncertainty can confound managed competition: CaLPERS premiumriseexceeded
national average (1982-1992), 9.4% national, 9.8% for CalPERS HMOs and 12.9% for CalPERS
fee-for-service PPOs, despite operating in a managed competition framework (The New Republic,
March 1993).
". ..There's mountingriskyour health insurer will fail, leaving you with unpayable bills. The toll is
cutting across every kind of medical payment group. According to S&P, 121 life and health
insurance companies went broke in the past 3 years. Blue Cross/Blue Shield of Charleston W. Va.
collapsed in 1990 leaving $41 million in unpaid bills. At least 131 HMOs failedfrom1986 to
1990...Unknown numbers of'multiple employer welfare arrangements' have gone broke, often
throughfraud..."(Quinn, Washington Post, March IS, 1992).
[Implication for Health Care Reform. Competition based on price alone is
insuflBcient to control cost of health care because the product of health care is not
defined, and consumers are not in a position to guess at what the actual product is
or what its value is. Comparison and shopping by consumers is in effect
impossible. Likewise, accountability for achievement of progressively better value
for the price is not possible since neither the product (outcome, output) of health
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2
care, the quality of that product, nor in fact the productivity (volume, frequency,
prevalence of the desired outcome) of the health care enterprise are measured or
managed in a rigorous way. We do not understand what treatments work to
restore patients to health and keep them well. Given the poor inter-observer
agreement in other studies (see above), it is very difficult to judge whether CABG
appropriateness described above was in fact a big or a small problem. With this
level of uncertainty, how will AHPs be able to predict the utilization rates
necessary to keep their members healthy? How will AHPs be able to manage the
plan and allocate resources among various alternative forms of care? How will
AHPs be able to compute the premiums they will charge if they cannot predict
demand based onrisk-adjustmentof their own membership? What will keep AHPs
from coming back to Congress to ask for bailout?]
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FACILITATING INTERNAL PROVIDER QUALITY IMPROVEMENT IN
NATIONAL HEALTH CARE REFORM
Purpose of this document: To suggest options for stimulating and documenting internal
quality improvement (Le., within provider organizations), as part of the proposed quality
improvement program of the national health carereformbill
Overview: Providers and plans must be accountable for documented improvement of outcomes
(e.g., health status, quality of life, cost containment or reduction and satisfaction) and supporting
quality improvement activity. To achieve impact, providers willrequireresourcesby way of staff,
education, technical assistance, measurement instruments and intervention strategies to effect and
maintain ongoing behavioral and organizational change.
Based on worldwide* experience, evidence shows that the most substantial impact on healthcare
outcomes occurs when local providers are personally committed, empowered, trained, and
providedresourcesto undertake quality improvement.
The proposed legislation will provide strong incentives for All care providers to expend an
appropriate amount of their gross revenues on quality improvement These incentives (e.g.,
receipt of state or federal funding, tax exemptions, or certification as an AHP) will be structured so
that the major portion of these funds be spent on quality improvement projects within the
organization or plan. A small proportion will be dedicated to whatever external reporting
requirements that may be imposed, e.g.,reportcard data. In consultation with consumers,
providers will set their own priorities and pursue whatever quality improvement activities they
consider worthwhile. They may work alone, or collaborate with other providers in networks or
consortia to improve outcomes.
The states will be givenresponsibilityfor facilitating internal quality improvement. The states may
follow various strategies to achieve this goals. The following are two alternative strategies that
might be followed by an individual state to provide theresourcesneeded for facilitating internal QI
success.
• Strategy I: The state encourages the private sector to develop needed training, consultation and
measurement instruments on a fee-for-service basis, with the govemment playing a facilitative role
such as by providing standards for report cards, or electronic data interchange. In this option the
* (* See Proceedings of the International Congress on Healthcare Quality Improvement)
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quality of the resources will judged by: (1) The care plans who purchase them; (2) The ultimate
impact on quality improvement as certified by private sector quality auditors. The cost of this
system will be bome by the health care providers, with no need for govemment funding for these
purposes.
• Strategy II: The state govemment would choose to beresponsiblefor producing and distributing
neededresourcesfor internal quality improvement, such as practice guidelines, training programs,
technical assistance e.g., throughregionalquality improvementresourcecenters. In this option the
quality of theresourceswill assured by govemment accountability. A substantially increased state
budget will berequiredfor this purpose. Health care plans would incur minimal direct expenses
for these resources.
STRATEGY I : PRIVATE ENTERPRISE " Q I " RESOURCE PROVISION
We expect that some health plans will hire, train or contract for theresourcesnecessary to effect
outcome improvement. Given this new demand, we expect the private sector torespondwith
innovative services, information, measures, training, or technical assistance. The public sector
will need to protect consumers (e.g., truth in advertising) and assure accountability (e.g., a report
card of certified accuracy).
Description:
• Finance & Budget: The providers will pay for the cost of improving and documenting quality.
By this model, the expenditures required by the NB/DHHS or HIPC/RQMC to oversee and certify
data and outcome improvementreportswill be small However, expenditures by the provider
plans will be more farreaching,e.g., up to 1% ofrevenues.This cost estimate is based on actual
experience from some of the better managed health care plans.
» Examples of Expected Activities:
1. Top management commitment. Top management would demonstrate their commitment by their
actions. They would have thisresponsibilityin everyone's job description, would pay for
allocated time of staff to fulfill thisresponsibility,provide needed resources, such as training,
measures, or outside technical assistance, and lead the celebration of major improvement success.
2. All staff have a role: To meet accountability standards, each health plan or other provider
would organize specific "process action teams" directlyresponsiblefor the carerelatedto potential
outcome improvement. These teams would be trained to efficiently test the high priority
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improvement hypotheses generated. When the hypothesis was confirmed, appropriate
improvement actions would be implemented and outcomes reassessed to determine impact
3. Role of process action teams: Interdisciplinary teams within the provider plan will generate
improvement hypotheses by a variety of methods, most of which would NOT require large data
sets or electronicrecordsystems immediately. Electronicrecordsystems will greatly facilitate the
process, and plans with a commitment to quality improvement will have strong incentives to
expedite the implementation of these information systems. In the start-up stage the following
methods for identifying QI topics might be used: (a) Inter-disciplinary (including consumers)
generation of ideas from experience by structured group judgment consensus techniques, utilizing
surveyresultsfrom other providers and consumers; (b) Study team analysis of the "Certified
Improvement Success Projects" compendium; (c) Study team analysis of scientific literature for
recent technology assessment information or other validated clinical advances that might effect
immediate improvement, e.g., 2 hr time window for surgical prophylactic antibiotic use; (d) Study
Team analysis of any availablerisk-adjusteddata sets (e.g.,reponcare quality measures) for
variation analysis to identify potential outcome improvement topics; and (e) Study team analysis of
past effort to effect improvement in the light of the new training, and availability of new
assessment tools and measures.
4. Management ofQI: The provider plan would analysis its outcome improvements and the cost
of their attainment to assure continuing improvement of their QI system effort.
5. Private sector initiatives: The private sector would offer a wide variety of resources from
formal courses in quality improvement principles, to guideline selfjction and applications. There
would be active competition among such suppliers to develop and adapt resources to the needs of
local providers.
6. Accountability through audit. Private sector auditors will certify the accuracy of provider plan
information. However, to avoid an appearance of conflict of interest, auditors will not be
permitted to act as consultants to the providers they have audited. (While auditors may identify
deficiencies.tp beremedied,they cannot sell services to effect the remedy.)
STRATEGY II: PUBLIC "QI" RESOURCE PROVISION
Overview: This option is essentially the same as thefirstexcept that theresourcesneeded for
internal quality improvement will be provided primarily by the state government at minimal
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expense to the health care plans. The first model leaves the production of these resources to die
private sector in response to demand. (For example, cunent consulting firms offering Continuous
Quality Improvement, or Total Quality Management training and consultation.) The second model
gives responsibility for developing and distributing these critical resources to the state government
(An example might be the Agricultural Extension Service that offered education, training and
consultation to farmers.)
Description:
• Finance & Budget: The state govemment budget will pay for development and distribution of
quality improvement resources. This could cost the state several million dollars, depending upon
how many quality improvementresourcecenters are needed. The provider plans will continue to
pay their own QI activities using these publicly provided resources.
«Examples of Expected Activities:
1. State supported quality resource centers: Provider plans will be encouraged to join regional
quality improvement resource centers supported primarily by the state govemment These centers
will provide technical assistance, training, guidelines, and technology assessments related
speciflcally to the health care needs of eachregion.The state government would subsidize
purchasing of computer and communications equipment to be dedicated to quality improvement
activity, particularly in rural or impoverished areas.
2. Quality improvement consortia: Provider plans will be encouraged to form quality
improvement consortia, to share quality improvement experience so that all may benefitfromeach
other. Competition willrelateto their accomplishments in improving healthcare outcomes.
3. State provided QI resources: The state would offer a wide variety of resources from formal
courses in quality improvement principles, to practice guidelines, or outcome measures. This
might be more appropriate for small states. The state might contract with outside agencies or firms
to compile these resources
4. Internal QI activities: The activities 1 through 4 for Strategy I wouldremainessentially the
same.
5. Accountability: The state may audit provider plans' information or contract with private sector
auditors to certify this quality improvement information.
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PROPOSED QUALITY MANAGEMENT SYSTEM FOR
HEALTH CARE REFORM
A. Overview. Health Care Reform can transform the assurance of health care
quality. The current system uses retrospective review to measure compliance with State,
Federal, and private sector rules and with poorly-defined clinical standards, and it
provides little information to consumers and purchasers. The proposed system will apply
to the entire country and to all payers and will
o
give consumers and purchasers information on quality to help them make
better choices among health plans, facilities, and individual practitioners,
o
empower institutions and front-line physicians with information and
technical assistance that helps them provide better care,
o
set essential performance standards for health plans and institutional
providers,
o
give Congress and the public information to assess the success of health
care reform in supporting quality care, and
o
strengthen the knowledge infrastructure for quality care through evaluation
research, technology assessment, and patient care guidelines.
Over the next decade, the system's ability improve quality through information feedback
and consumer demands will increase dramatically as information systems and new
knowledge enhance our ability to apply science to improving and measuring quality.
B. Organization. The proposed system is decentralized.
o
Health plans will measure and disclose their performance on quality
measures (subject to State audit) and be accountable for maintaining and
improving the care their providers and practitioners deliver.
o
Purchasing cooperatives and other purchasers will use information on
quality of care to select and negotiate with plans; they will not be
responsible for collecting or validating the information.
o
State quality programs will gather data from plans, survey consumers,
prepare reports to inform consumers and providers, transmit collected data
to the Federal program, and help providers improve their care. State
licensing programs will assure that institutional providers meet standards
and that health plans meet conditions of participation. Federal contracts
and grants will support the core of State efforts (annual budget $238M).
o
The Federal govemment (annual budget $70Nf) wfll develop quality
measures and consumer surveys, support the research and pilot projects
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necessary for quality measurement, develop performance-based licensing
standards for institutions, prepare annual reports on Federal and State
efforts.
C. Information on quality. The system will measure access to care,
appropriateness of care, outcomes of care, and consumer satisfaction. Information will
come from records routinely generated in the process of providing care and from
consumer surveys. Tne Federal govemment will define a core set of measures to be
reported by plans and will define the core of a survey to be conducted by States; States
will add measures and survey questions thatfitlocal priorities. Some validated measures
are available today, but increased research activity and improvements in patient care
data systems will make measures both more accurate and more broadly applicable over
the next few years; for the present, plans will have to abstract some medical records as
well as process automated data in order to apply some measures. The State will
combine information reported by plans with that developed by surveys into a report that
describes plans on perhaps S measures and describes institutional providers and
O
individual practitioners on a smaller number of measures for which adequate
information is available. Hie State analysis will include trends and other information
indicating the success of quality improvement activities. Each user (such as a purchasing
cooperative) will select and organize this information for its own needs. The measures
will change over a period of years in order to cover a wide range of quality issues, reflect
medical progress, and assure that measures remain representative of overall plan
performance.
D. Technical Assistance. States will give plans, providers, and practitioners
technical assistance to help them to measure their performance accurately and to
improve that performance. Assistance will include convening groups of providers with
similar problems, leading efforts to identify the root causes of problems, suggesting
solutions that have proven successful for other providers, and coordinating community
and provider efforts. Technical assistance in quality improvement will emphasize areas
where there is diminished competition and problems that exist across plans. Plans,
providers, and practitioners will not be required to accept assistance and assistance will
not be tied to licensure or payment. The nattonal program will develop technical
assistance methods and fund State technical assistance programs. Medicare Peer Review
Organizations (PROs) are already piloting important parts of this proposal in their new
contracts and will immediately begin to pilot others; when the Medicare population
cviiica undei piulcdiuu of ihc quality managemenl system, PROs will be discontinued.
E. Consumer protection and essential standards. There will be essential standards
for providers in three areas:
1. Health plans. To participate, plans must meet basic conditions including: 1)
fiscal soundness; 2) truth-in-marketing standards; 3) policies for protecting patient
privacy and confidentiality; 4) disclosing their performance and other information;
5) providing formal appeals and grievance procedures; 6) disclosing their
utilization management protocols; 7) promulgating enrollee rights and
responsibilities; 8) achieving quality improvement, and 9) reporting required
quality measures to the State. The conditions will be set by federal legislation,
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but administered and enforced by States.
2. CJinicaj ubwatories, llic Clinical Labwatories Imprwement Art (CLIA)
will be dramatically simplified to focus on quality control procedures, test
accuracy, and specimen handling. Mandatory proficiency testing will be
eliminated; labs will no longer pay fees and file forms to be waivered (about a
third of labs). Further exemptions will follow unless 1993 survey results indicate
need for continued surveys.
3. Institutional providers. The Federal government will develop performance
standards, largely based on outcomes, which will operate through State licensure
and will, over the next 5 years, replace both the current program of Medicare and
Medicaid certification and current State licensure. Federal incentives will be the
primaiy tool for strengthening and simplifying State practices. Focusing surveys
on providers with problems, will reduce both program costs and provider burdens.
F. National oversight. The President will appoint a National Quality Advisory
Committee, which will oversee the national program and its annual reports on
performance of the national and State programs. The Committee will also review the
report card, all State waivers, and development of performance-based licensing. The
Department of Health and Human Services should begin to design an evaluation of the
impact of health care reform pn quality pf care without waitingforpassage of legislation.
G. Guideline Development Utilization Management and Closely Related
Research. To support activities directly related to the report card and quality
improvement the Federal govemment will
o
develop the practice guidelines necessary for measures on the report card
and for the measures of institutional performance that will replace existing
requirements for licensure and certification,
o
support research on topics central to quality management, including
dissemination methods, quality measurement, and design of information
systems.
o
develop methodological standards for guidelines and a voluntary evaluation
and certification process for guidelines,
o
develop standards for utilization management protocols,
o
disseminate information on clinically ineffective uses of treatments, and
o
set priorities for evaluation research to support clinical practice guidelines,
define specific research projects related to these priorities and carry out
these projects (year 1: $35M; year 5: 95M).
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Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
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Health Care Reform
Identifier
An unambiguous reference to the resource within a given context
2006-0810-F
Description
An account of the resource
<p>This collection consists of records related to Hillary Rodham Clinton's Health Care Reform Files, 1993-1996. First Lady Hillary Rodham Clinton served as the Chair of the President's Task Force on National Health Care Reform. The files contain reports, memoranda, correspondence, schedules, and news clippings. These materials discuss topics such as the proposed health care plan, the need for health care reform, benefits packages, Medicare, Medicaid, events in support of the Administration's plan, and other health care reform proposals. Furthermore, this material includes draft reports from the White House Health Care Interdepartmental Working Group, formed to advise the Health Care Task Force on the reform plan.</p>
<p>This collection is divided into two seperate segments. Click here for records from:<br /><a href="http://clinton.presidentiallibraries.us/items/browse?advanced%5B0%5D%5Belement_id%5D=43&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=2006-0810-F+Segment+1"><strong>Segment One</strong></a> <br /><a href="http://clinton.presidentiallibraries.us/items/browse?advanced%5B0%5D%5Belement_id%5D=43&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=2006-0810-F+Segment+2"><strong>Segment Two</strong></a></p>
Provenance
A statement of any changes in ownership and custody of the resource since its creation that are significant for its authenticity, integrity, and interpretation. The statement may include a description of any changes successive custodians made to the resource.
Clinton Presidential Records
Publisher
An entity responsible for making the resource available
William J. Clinton Presidential Library & Museum
Text
A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.
Original Format
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Paper
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
A name given to the resource
Quality Briefing Book [1]
Creator
An entity primarily responsible for making the resource
Health Care Task Force
General Files
Identifier
An unambiguous reference to the resource within a given context
2006-0810-F Segment 1
Is Part Of
A related resource in which the described resource is physically or logically included.
Box 55
<a href="http://clinton.presidentiallibraries.us/items/show/36144" target="_blank">Collection Finding Aid</a>
<a href="https://catalog.archives.gov/id/12090749" target="_blank">National Archives Catalog Description</a>
Provenance
A statement of any changes in ownership and custody of the resource since its creation that are significant for its authenticity, integrity, and interpretation. The statement may include a description of any changes successive custodians made to the resource.
Clinton Presidential Records: White House Staff and Office Files
Publisher
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William J. Clinton Presidential Library & Museum
Format
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Adobe Acrobat Document
Medium
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Preservation-Reproduction-Reference
Date Created
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5/5/2015
Source
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42-t-2194630-20060810F-Seg1-055-001-2015
12090749