1. Comparative Effectiveness Research: Understanding What It Is and Helping to Shape the Future Course Debra Ness Co-Chair, Consumer-Purchaser Disclosure Project President, National Partnership for Women & Families Peter V. Lee Co-Chair, Consumer-Purchaser Disclosure Project Executive Director, National Health Policy Pacific Business Group on Health Invitational Working Session May 5, 2009

2. 1 Agenda Welcome 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. 2 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 proportion of recommendations with high evidence levels has not increased over time

4. 3 Problem 2: When There Is Evidence, It Is Frequently Not Followed… Regional variation in quality and cost US: 10 th in life expectancy; 27 th 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 care 56.1% = Chronic care

5. 4 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 90 th 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. 5 Problem 3: Rising Costs Are Unsustainable for All Percent Source: Congressional Budget Office, 2008 Projected Spending on Health Care as a Percentage of Gross Domestic Product

7. 6 Health Reform Elements Major Policy AreaCritical Value Policies Coverage expansion and Financing 1. Align public and private policies 2. 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 decisions 7.Payment reform – Change payments AND the decision process Infrastructure 8. Patient-centered comparative effectiveness 9. HIT that promotes better care 10. Foster innovation

8. 7 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. 8 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. 9 Doing Comparative Effectiveness Right: Big Money, Big Interests and Bad Messaging

11. 10 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. 11 Consumer-Purchaser Principles on Doing Comparative Effectiveness Right: Discussion Draft – May 5, 2009 1.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. 12 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, MPH Associate Director 415-281-8660 jeames@healthcaredisclosure.org About the Disclosure Project