Transcript Slide 1

Comparative Effectiveness Research:
The Consumer and Patient Perspective
Moderator:
Debra L. Ness, President
National Partnership for Women & Families
Co-Hosts:
National Partnership for Women & Families
Community Catalyst
Leadership Conference for Civil Rights
AARP
Consumers Union USPIRG
Agenda

Welcome and Context


How CER can Improve Care


Steve Findlay, Consumers Union
Communicating Effectively About CER


Katie Maslow, Alzheimer’s Association
CER in Federal Policy


Dr. Garth Graham, Office of Minority Health
CER and Older Americans


Dr. James King, AAFP
CER and Minority Health


Debra Ness, National Partnership for Women & Families
David Mermin, Lake Research Partners
Key Issues for Consumers and Patients

Debra Ness, NPWF
What is CER?

Congressional Budget Office:
“Comparative effectiveness is simply a rigorous evaluation of
the impact of different options that are available for treating a
given medical condition for a particular set of patients.”

MedPAC:
“Comparative-effectiveness analysis evaluates the relative
value of drugs, devices, diagnostic and surgical
procedures, diagnostic tests, and medical services.”

Federal Coordinating Council:
“CER is the conduct and synthesis of systematic research comparing
different interventions and strategies to prevent, diagnose, treat and
monitor health conditions.”
More Simply:

Information about what works and what doesn’t

Information that helps clinicians and patients choose the
options that best fit patients’ needs and preferences



Better targeting of treatments to the patients who will benefit
Takes into account that patients respond to treatments differently
Can include a range of treatments, services, drugs,
devices, interventions, and models of care
Why is CER Important Now?

Current System: Quality and cost problems abound


“Health Care Reform”


According to the IOM, as much as 1/2 of the care provided in the US is not based on
adequate evidence
Better information can help us drive toward “better care”




Need to get more for our health care dollars
Lack of evidence


Disparities, variations in care, safety
Key to truly patient-centered care
Expands choice
Enables care to be more “individualized”
Federal legislation


ARRA – $1.1B
Proposals in health care reform
Comparative Effectiveness
Research
Jim King, MD, FAAFP
Board Chair, AAFP
July 16, 2009
Background
• The AAFP has more than 94,600
members and is the only medical society
devoted solely to primary care.
• Nearly 1 in 4 of all office visits are made to
family physicians - 208 million visits each
year.
• In our fragmented world of health care,
family physicians treat the whole person,
across all ages.
AAFP’s Strong Support for CER
• AAFP strongly supports comparativeness
effectiveness research
• If we want to improve patient care and
control costs in the US, CER is crucial.
• The AAFP has supported CER before
Congress, Institute of Medicine, Agency
for Healthcare Policy and Research.
Current Problems
• Family physicians see patients with
common problems every day for which
there is no solid clinical evidence.
• This is true despite the many randomized
clinical trials that are conducted each year.
• Due to our broad scope of practice, we
deal constantly with gaps in medical
knowledge.
Better Care for Patients
• CER means careful analysis of the relative
benefits and costs of various treatments
across populations and illnesses.
• AAFP does not believe that more
knowledge about how various treatments
and products compare with each other will
lead to rationing, as some have said.
Better Care for Patients (cont.)
• The Academy believes that the more
objective information physicians and
patients have about health care issues the
better their choices will be.
Health of the Public is Key
• We know that as CER develops, some
therapies will be proven to work better
than others and some will challenge the
results.
• We believe the health of the public should
trump individual business concerns.
• Healthcare cannot be the only decision
consumers make without taking cost into
account.
Health of the Public (cont.)
• Nevertheless, we oppose limits on
physician-prescribed interventions if it is
the most appropriate therapy for our
patient.
• Our primary concern is the health of our
patients and the public.
Your Questions = Better Care
•
•
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Which treatments adds the most value?
How soon should I repeat the lab?
How soon should I increase medicines?
Do I have support when I say no?
When do I stop?
Policy Recommendations
• The AAFP is supporting the CER
provisions in the health reform bills.
• We believe that the Agency for Healthcare
Quality and Research is the right agency
to do this.
• We need research on the conditions family
physicians see each day in their practices.
Policy Recommendations (Cont.)
• CER requires consideration of different
patient populations, comorbidities, cultural
differences and values.
• Funding for CER must be ongoing. We
will not answer all the questions over the
next few years.
CTEP – FDA Concept Review
Comparative Effectiveness
Research Webinar: CER and
Minority Health
Garth N. Graham, M.D., MPH
Deputy Assistant Secretary for Minority Health
HHS/Office of Minority Health
July 16, 2009
As of April
2004
17
Highlighting Critical Topics
• Disparities in care among minority populations
• Strategies to strengthen current research to
address the needs of minority populations
• Concerns about CER among minority groups
• Policy implications for consumer advocacy
As of April
2004
Disparities in Health Care
Demonstrated
substantial racial and
ethnic variation in
quality of health care
Highlighted health care
disparities
Advanced key disparity
issues to forefront of the
nation’s health policy
agenda
As of April
2004
2008 National HealthCare Disparities Report (AHRQ)
Provides a snapshot of health
care delivery
Indicates the biggest gaps in
care
Shows National and State
trends
Helps align measures across
public and private quality
initiatives
As of April
2004
Health Disparities
• Racial/ethnic minorities more likely to possess
risk factors for obesity & high cholesterol and
increased rates for cardiovascular disease
• American Indians, African Americans, and
Latinos noted as rating their health as fair or
poor compared to Whites/Asians
• Latinos accounted for 67% of newly reported
AIDS cases
Source: Key-Facts-Race-Ethnicity-Medical Care Chart book-Kaiser Family
Foundation, June 2003; State of Disparities in Cardiovascular Health in the U.S,
Circulation 111 (March 2005).
As of April
2004
Health Disparities
• African American women are 34% more likely
to die from breast cancer, although they are
diagnosed 10% less frequently than White
women
• Asian/Pacific Islander children were 3.4 times
more likely than White children to be
diagnosed with acute Hepatitis B virus
• More than 10 percent of Hispanics aged 20
years and older have diagnosed diabetes
As of April
2004
Strategies to Strengthen Current Research
• Increase data sources for evidenced based
studies in diverse populations
• Monitor race and data collection
• Include linguistic and cultural attributes of
patients
• Utilize more community based participatory
research studies
As of April
2004
Strategies (cont.)
• Prepare the field upstream to have a more
diverse generation of researchers
• Improve the numbers of researchers who
focus on underserved populations
• Increase minority participation in research
protocols
- use promotoras to assist with
recruitment and retention
As of April
2004
Concerns About CER Among Minority Groups
• Recognize and account for the variation in outcomes of
medical treatments
• Address the comparative effectiveness of different health
system strategies in order to reduce health disparities and
close the gap between care that we know works well and
care patients actually receive
• Bolster and expand information and knowledge about
quality without restricting access to care
As of April
2004
Policy Implications for Consumer Groups
• Engage in activities to increase the
awareness of health disparities
• Work with local and community based
organizations on grass roots strategies
• Maximize partnerships at all levels
As of April
2004
Contact Information
Garth N. Graham, MD, MPH
Deputy Assistant Secretary for Minority Health
HHS/Office of Minority Health
(240) 453-2882
www.omhrc.gov
As of April
2004
Illustrating the Problem and How
CER Can Help:
CER and Older Americans
Katie Maslow
Alzheimer’s Association
July 16, 2009
Three Defining Features of CER

Focus on real people

Focus on answers that are needed to make
decisions about care at the individual or
population level

Focus on care delivery systems
Problem: Lack of Research on Care for
People with More than One Disease

72% of older people have more than one chronic
disease, and many also have acute diseases

Research is generally not available to make
decisions about care of people with more than one
disease – it’s hard to do this research

Older people with more than one disease are more
likely to be hospitalized, more likely to have
potentially preventable hospitalizations, and more
likely to have poor health outcomes
CER Focus on Real People/Real
Decisions

Federal Coordinating Commission Report: 6/30/09
“The priority populations specifically include …. the
elderly and patients with multiple chronic conditions.”

IOM Report: 6/30/09
“Compare the effectiveness of aggressive medical
management and percutaneous coronary interventions
in treating stable coronary disease for patients of
different ages and with different comorbidities”
Problem: Lack of Research on How to
Deliver Care Effectively

Most older people see several different physicians and
other health care professionals, receive many different
prescriptions, and need and use health-related
community and long-term care services

Fragmented care – lack of coordinated delivery
systems -- results in serious gaps in care,
unnecessary duplication of tests, medication errors,
and poor health outcomes and quality of life
CER Focus on Care Delivery Systems

IOM Report: 6/30/09
“Compare the effectiveness of coordinated care
(supported by reimbursement innovations) and usual
care in long-term and end-of-life care of the elderly”
“Compare the effectiveness of diverse models of
transition support services for adults with complex
health care needs (e.g., the elderly, homeless, mentally
challenged) after hospital discharge”
Benefits for Non-Elderly Adults
and Children

Most non-elderly adults with one chronic disease have
more than one: e.g., 2/3 of non-elderly adults with
chronic lung disease have 1 or more other diseases

Most children with one chronic disease have only one,
but most children with a serious, debilitating chronic
disease have more than one chronic disease

CER on real people, real decisions and care delivery
systems will also benefit non-elderly adults and
children
Examples of Recommended CER Topics

IOM Report: top 100 out of 2,600 proposed topics*

Effectiveness of different models of comprehensive support for
infants and families after discharge from neonatal intensive
care
Effectiveness of school-based interventions to prevent and treat
obesity in children
Effectiveness of literacy-sensitive management programs in
reducing health disparities in children and adults with chronic
disease
Effectiveness of different mindfulness-based interventions (e.g.,
yoga, meditation) to treat anxiety, depression, and pain


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*List of 100 topics at http://www.iom.edu/CMS/3809/63608/71025/71032.aspx
Concerns of Older People About CER

? Like other people, many older people probably
don’t know what CER is, and most are probably
susceptible to messages about government
controlling their health care choices

Possible responses:
– Information to inform many different health care choices,
including choices you will need to make for yourself or your
family members, is not available now
– Examples of recommended topics for CER research
– Other ?
Consumer Advocacy
1.
The Federal Coordinating Council and IOM reports contain
strong, repeated messages about consumer involvement in
all phases of CER: advocates need to be sure this
involvement happens and is meaningful
2.
This kind of research is difficult: advocates need to be sure
the money is spent on research about real people, real
decisions, and coordinated delivery of care
3.
All of us are susceptible to messages about who controls our
health care choices: advocates need to understand and
convey the messages about why this kind of research is
essential
Comparative Effectiveness Research
Steven Findlay
Consumers Union
July 16, 2009
CER and Health Care Reform
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ARRA (the stimulus legislation) – $1.1B
Will be spent over many years
NIH got $10B for basic and applied research
Mandated IOM and Fed Council Reports released June 30
Sebelius plan for HHS $400M due on July 30
“Infrastructure” but also initial research projects
Initial set of research priorities from IOM
So, got the ball rolling, as intended. But still early
Key Points of Debate
• Independent entity or housed within HHS/AHRQ
• How will this be paid for?
• Role of cost information
The Bills
• Three: House Tri-Committee, Senate Finance, and
Senate HELP
• Some big differences but major thrust the same
• Consistent with ARRA
• Main Point: establish a permanent federal program
• Also: reposition federal medical research enterprise
• And: dramatically ratchet up “patient care” oriented
research
The House Bill
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•
•
•
•
•
•
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Sec. HHS to establish a new Center in AHRQ for CER research
Meld with existing MMA (“Sec 1013”) program at AHRQ
“full spectrum of health care services”
Sec. to establish independent CER Commission to “oversee and evaluate”
the activities of the new Center
17 members, multi-stakeholder. Usual suspects. One Consumer. 3 to 4
year terms. Sec. to appoint with consult of IOM and GAO. COI must be
taken into account. Full disclosure.
Sec. establishes a “clinical perspective advisory panel” for each research
priority
$$$ - Trust fund at Treasury - $300M 2010-2012. Then “all payer”
contributions based on a per capita assessment of insurers, and self
insured plans, and Medicare (various pots of $ there). To yield $375M in
2013.
No restrictions/limits on use of findings for payment/coverage - !!
The Senate HELP Bill
• New program at AHRQ: Center for Health Outcomes and
Evaluation
• A multi-stakeholder CER Advisory Council.
• 20 members. One consumer. Sec. appoints. 2-4 years
• Requirements around dissemination
• COI provisions quite weak – one sentence.
• Has restriction-of-use language: “recommendations shall
not be construed as mandates for payment, coverage or
treatment”
• $$$: No jurisdiction. Left to Finance Committee
The Senate Finance Bill
• No language on entire bill, but CER portion (“Conrad-Baucus”
2008) pre-existed. New version June 9
• 65 pages. Contrasts sharply with HELP bill
• Sets up independent public-private CER entity that is “neither
an agency or establishment of the U.S. government”
• Latest name: “Patient-Centered Outcomes Research Institute”
• Led by a multi-stakeholder board appt. by Sec.
• $$$. Trust fund: general revenues then, starting in 20132015: $2 per Medicare beneficiary/yr from MTF and $2 per
covered life from insurers and self-insured plans. $600B/yr
after five years.
• No restriction-of-use language per se, but some constraints
The Debate
• HELP mark-up already batted down amendments to restrict
use for coverage or payment decision in federal programs
• Expect same or worse in House and in Senate Finance. Also
possibly on floor. Already being circulated.
• Retrospective to the ARRA $$$!!
• Also expect: language on “treatment response,” “personalized
medicine,” treatment preferences” and “the unique needs of
health disparity populations”
• We need to be on top of this and fight hard to prevent any
restrictive language
• “Why?” Congress should not be dictating the specifics of how
CER results/findings should or should not be used to improve
care. That has to evolve.
Voter Attitudes on Comparative
Effectiveness Research
National Partnership for Women & Families
CER Webinar
July 16, 2009
Presented by David Mermin, Partner of Lake Research Partners
Herndon Alliance
202.776.9066 | www.lakeresearch.com
Methodology
•
Lake Research Partners designed and administered this survey that
was conducted by telephone using professional interviewers between
February 2-8, 2009.
•
The survey reached a total of 800 likely voters nationwide.
•
Telephone numbers for the sample were generated by random digit dial
(RDD) methodology. The margin of error for this survey is +/- 3.5%.
47
Voters tend to trust their doctors’ judgment over scientific
research. This presents a challenge for comparative
effectiveness reform advocates.
Which of these two statements comes closer to describing your own views?
-21
points
While a doctor’s personal experience treating
patients is important, sometimes the best
evidence about health care treatments comes
from scientific studies, even if it conflicts with
your doctor’s experience.
30%
While evidence from studies is important,
sometimes the best recommendations about
care come from your doctor’s experience and
observations, even if they conflict with the
scientific evidence.
Both/Neither/Don’t know
51%
18%
48
Instituting comparative effectiveness reforms to
supplement doctors’ clinical knowledge has solid support.
Voters need to be reassured that scientific research does
not replace nor challenge their doctor’s judgment.
We should create an independent national organization that
supports health care providers by giving them information
about the most effective treatments. This information would
be based on the best available evidence from scientific
research and would help ensure that doctors are relying on
independent evidence as well as their own personal
judgment when making decisions about a patient’s care.*
73%
+56
points
We should create an independent national organization that
supports health care providers by giving them information
about the most effective treatments. This information would
be based on the best available evidence from scientific
research about clinical benefits and costs, and would help
ensure that doctors are relying on independent evidence
about the best and most cost effective treatments, as well
as their own personal judgment when making decisions
about a patient’s care.*
70%
+51
points
45%
45%
19%
17%
11%
9%
11%
7%
Favor
Oppose
Undecided
Favor
Darker color indicates intensity
* Asked of half of sample.
Oppose
Undecided 49
However, voters are mixed over comparative effectiveness
research if it means their health insurance coverage will be
based on it.
What if this evidence were used to decide what is and isn’t covered by your health insurance plan?
Would you support or oppose this proposal, or are you undecided?
41%
43%
26%
21%
Support
Oppose
16%
Undecided
50
Darker color indicates intensity
Messages in favor of reform test very strongly, especially
messages that reinforce giving doctors information to
provide good care.
Now I am going to read you a series of statements people have made in support of health system changes
like those we have been discussing. Please tell me whether each is a very convincing, somewhat
convincing, not very convincing or not at all convincing reason to support these changes to the health
care system.
% Convincing (intensity in dark)
Comparative
Effectiveness w/out
costs*
Comparative
Effectiveness
w/costs*
Evidence-based
Medicine*
46%
40%
36%
84%
81%
78%
51
* Asked of half of sample.
Text of Most Effective Messages
[Comparative Effectiveness w/out Costs] We need to make sure doctors have
access to the latest research that compares the effectiveness of different types of
treatments, such as comparing which drugs work best. That will help doctors and
patients choose the best treatment for their patients’ situation and make more
informed choices rather than risk receiving less effective treatments.
[Comparative Effectiveness w/Costs] We need to make sure doctors have
access to the latest research that compares the clinical and cost effectiveness of
different types of treatments, such as comparing which drugs work best. That will
help doctors and patients choose the best treatment for their patients’ situation
and make more informed choices rather than waste money on less effective
treatments.
[Evidence-Based Medicine] Advances in health care occur so fast we need to
provide doctors with constantly updated information based on the most current
scientific evidence available. The best information should be available to your
doctor and only effective health services should be covered. This would help your
doctor do what’s right for you and give you the best quality care.
52
Second tier messages about reducing over-use of the
health care system and helping doctors avoid malpractice
suits are still strong, but lack intensity.
Now I am going to read you a series of statements people have made in support of health system changes
like those we have been discussing. Please tell me whether each is a very convincing, somewhat
convincing, not very convincing or not at all convincing reason to support these changes to the health
care system.
% Convincing (intensity in dark)
Less is More*
33%
Evidence-Based
Medicine w/Liability*
33%
80%
77%
53
* Asked of half of sample.
Text of Second Tier Messages
[Evidence-Based Medicine w/Liability] Advances in health care occur so fast we
need to provide doctors with constantly updated information based on the most
current scientific evidence available. The best information should be available to
your doctor and only effective health services should be covered. This would
reduce doctors’ risk of malpractice lawsuits and help your doctor do what’s right for
you by protecting doctors and enabling them to give the best quality care.
[Less is More] We have amazing advanced technology in health care, but just
because it’s there doesn’t mean we have to use it every time. Over-use of the
health care system contributes to the high cost of tests and treatments for everyone,
and often does nothing to improve our health and can actually harm it. We need to
support doctors with the best information about prevention, and the treatments that
actually work the best for patients.
54
In head-to-head statements, CER holds up against attack
when placed in a context of helping doctors focus on
providing high quality care.
Now here are two different statements about our health care system. Which statement comes closer to
describing your own views, even if neither is exactly right?
Doctor Relationship*
We need to overhaul how we pay for and deliver health care so that
doctors can focus on providing high quality care for you and your
family and so that patients have the best information necessary to
manage their own health and focus more on prevention. The health
care system should provide the right information and incentives for
doctors not just to provide more health care, but the most effective
high quality health care based on scientific evidence. This will make
the health care system more responsive to patient needs, more
convenient, and give us peace of mind.
56%
America has high quality health care because we allow doctors and
patients the freedom to choose the treatments and medicines that are
right for them, not faceless government bureaucrats. This so-called
reform is about putting the government in charge of our personal
health care decisions, tying the hands of your own doctor and
creating a one-size fits all health care system run by a huge, costly
new bureaucracy that we can’t afford in these tough economic times.
Both/Neither/Don’t Know
27%
17%
55
* Asked of half of sample.
A frame focused more on cost effectiveness is slightly
weaker against the attack.
Now here are two different statements about our health care system. Which statement comes closer to
describing your own views, even if neither is exactly right?
Economic*
We need to overhaul how we pay for and deliver health care so that we
get our money’s worth. The health care system wastes billions of dollars
on ineffective tests and treatments because doctors don’t have access to
updated medical records or the latest information on the most effective
treatments. We need a system that encourages high quality, costeffective health care that helps patients and doctors make the best
choices to promote good health, not decide based on what insurance
companies tell them to do.
53%
America has high quality health care because we allow doctors and
patients the freedom to choose the treatments and medicines that are
right for them, not faceless government bureaucrats. This so-called
reform is about putting the government in charge of our personal health
care decisions, tying the hands of your own doctor and creating a onesize fits all health care system run by a huge, costly new bureaucracy
that we can’t afford in these tough economic times.
Both/Neither/Don’t Know
31%
16%
56
* Asked of half of sample.
Key Consumer & Patient Issues

Independence

Transparency

Multi-stakeholder Input


Priority Setting, Methodology, Dissemination, Use
Scope



Include treatments, interventions, models of care
Compare similar and different approaches
Address benefits, harm, and resources

Address specific needs and differences among different populations and
patient types

Infrastructure


HIT
Workforce