Comparative Effectiveness Research:  Understanding What It Is and Helping to

Shape the Future Course

Debra NessCo-Chair, Consumer-Purchaser Disclosure Project

President, National Partnership for Women & Families

Peter V. LeeCo-Chair, Consumer-Purchaser Disclosure Project

Executive Director, National Health PolicyPacific Business Group on Health

Invitational Working SessionMay 5, 2009

2

AgendaWelcome and Introductions

– Debra Ness, Disclosure Project and NPWF

Setting the Context for Comparative Effectiveness Research – Peter V. Lee, JD, Disclosure Project and PBGH

Overview of CER and Key Issues– Steven Pearson MD, MSc, FRCP, Institute of Clinical and

Economic Review

Use of CER by CMS and Private Payers – Sean Tunis MD, MSc, Center for Medical Technology Policy

Roundtable Discussion– Peter Lee, JD, Disclosure Project and PBGH

3

Problem 1: Much of Care Today is Not Based on Scientific Evidence

Robert Califf, IOM Meeting on Evidence-based Medicine, December 2007

Less than 20% of AHA/ACC heart disease management recommendations are based on a high level of evidence and over 40% are based on the lowest level of evidence AND proportionof recommendations with high evidence levels has not increased over time

4

Problem 2: When There Is Evidence, It Is Frequently Not Followed…

Regional variation in quality and cost

US: 10th in life expectancy; 27th in infant mortality

Avoidable harm: 99,000 deaths in hospitals from health care acquired infection

Overuse: 13 million unneeded antibiotic RX

Adults receive about half of recommended care:

54.9% = Overall care 54.9% = Preventive care 53.5% = Acute care56.1% = Chronic care

5

If care provided nationally AS IT IS to 4 million Medicare beneficiaries, we could save 29% of Medicare spending

WITH coordinated care – risk of heart disease mortality reduced 30% (example of Kaiser No.Cal)

Thousands of hospitals participating in the 5 Million Lives Campaign – many hospitals proving ZERO infections is doable

If all health plans performed at the NCQA’s 90th percentile – over 40,000 lives would be saved each year and over $2 billion

…But We Do Know Following Evidence Can Dramatically Improve Care

6

Problem 3: Rising Costs Are Unsustainable for All

2007 2012 2017 2022 2027 2032 2037 2042 2047 2052 2057 2062 2067 2072 2077 2082

0

5

10

15

20

25

30

35

40

45

50

All Other Health Care

Medicaid

Medicare

Percen

t

Source: Congressional Budget Office, 2008

Projected Spending on Health Care as a Percentage of Gross Domestic Product

7

Health Reform ElementsMajor Policy Area Critical Value Policies

Coverage expansion and Financing

1. Align public and private policies2. Connector or Exchange promoting value

Benefits 3. Assure core benefits promote affordable “right care” 

System Reforms 4. Full measures and public reporting (including release Medicare data)

5. Promote wellness 6. Consumer and provider incentives for

shared decisions7. Payment reform – Change payments AND

the decision process 

Infrastructure 8. Patient-centered comparative effectiveness 

9. HIT that promotes better care10. Foster innovation

8

Comparative Effectiveness Research: Different perspectives on what it is…

“Comparative-effectiveness analysis evaluates the relative value of drugs, devices, diagnostic and surgical procedures, diagnostic tests, and medical services.” MedPAC

“Assessing the comparative effectiveness of health care treatments and strategies, through efforts that: (1) conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions.” ARRA 2009

“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.” Congressional Budget Office

• Head-to-head comparisons of drugs

• Drugs vs. surgical procedures

• Drugs vs. surgical procedures vs. public health interventions

• Physician outcomes vs. physician outcomes

9

Current CER Activity• American Recovery and Reinvestment Act of 2009 funded $1.1 billion

–$400 million NIH, $300 million AHRQ, $400 million HHS–Federal coordinating council to advise on priorities–IOM to produce priorities by June 30

• Triggered significant manufacturer pushback• Encourages the development and use of clinical registries, clinical networks, and other forms of electronic health

data • Role of costs/cost-effectiveness left unclear

• Congressional Proposals (e.g., Senate Finance Committee Options Paper)–Fund existing HHS entities through annual appropriations–Establish private, non-profit corporation• Fund through annual appropriations or by mix of public and private

–Coming this Summer -- comparative effectiveness legislation 2.0

10

Doing Comparative Effectiveness Right: Big Money, Big Interests and Bad Messaging

11

Comparative Effectiveness Research: Big Issues• Individualized Care vs. One-size Fits All• Ensuring Disparities Are Not Exacerbated (or ignored)• Common Conditions vs. Rare Diseases• Inclusion of Cost and/or Cost-Effectiveness• Paying for Unproven Care vs. “Rationing” or Denial of

Coverage• Rewarding What Works vs. Stifling of Innovation• Rigor of Scientific Evidence• Who Decides – what to research; what to do with the

results

12

Consumer-Purchaser Principles on Doing Comparative Effectiveness Right: Discussion Draft – May 5, 20091. Public investment: comparative effectiveness research is an important public good

that warrants substantial and ongoing public investment

2. Independence and governance: oversight of CER should be as removed as possible from political influence, with processes assuring patient, clinician, purchaser and other input.

3. Total transparency: determination of what to research and the research itself must be totally transparent

4. Effective coordination: there should be coordination across public and private funders of CER to assure that the right mix of questions are being asked, the right mix of methodologies are being used, and resources are being used efficiently

5. Prioritization: CER research should be prioritized on those areas with highest potential to assure patients get the right care (e.g., variation, overall poor performance, etc)

6. Scope: CER should assess multiple treatment types and interventions

7. Results: CER should generate results in areas that matter – outcomes, functional status, patient experience, utilization, expense of all care delivered based on treatment options and differences across populations

8. Dissemination: results of CER should be disseminated broadly for use by patients, clinicians, researchers and purchasers (and there should not be restrictions on use)

9. Health IT: health information infrastructure should be funded and aligned with CER

13

The Consumer-Purchaser Disclosure Project is an initiative that is improving health care quality and affordability by advancing public reporting of provider performance information so it can be used for improvement, consumer choice, and as part of payment reform. The Project is a collaboration of leading national and local employer, consumer, and labor organizations whose shared vision is for Americans to be able to select hospitals, physicians, and treatments based on nationally standardized measures for clinical quality, consumer experience, equity, and efficiency. The Project is funded by the Robert Wood Johnson Foundation along with support from participating organizations.

Previous Discussion Forums are available at: http://healthcaredisclosure.org/activities/forums/

For More Information Contact:Jennifer Eames, MPHAssociate Director415-281-8660jeames@healthcaredisclosure.org

About the Disclosure Project