Peter Lee 11/28/2018 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 Executive Director, National Health Policy Pacific Business Group on Health Invitational Working Session May 5, 2009 NBCH - NHCL

Agenda Welcome and Introductions Peter Lee 11/28/2018 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 NBCH - NHCL

Problem 1: Much of Care Today is Not Based on Scientific Evidence Peter Lee 11/28/2018 Problem 1: Much of Care Today is Not Based on Scientific Evidence 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 Robert Califf, IOM Meeting on Evidence-based Medicine, December 2007 NBCH - NHCL

Problem 2: When There Is Evidence, It Is Frequently Not Followed… Peter Lee 11/28/2018 Problem 2: When There Is Evidence, It Is Frequently Not Followed… Regional variation in quality and cost Adults receive about half of recommended care: 54.9% = Overall care 54.9% = Preventive care 53.5% = Acute care 56.1% = Chronic care Avoidable harm: 99,000 deaths in hospitals from health care acquired infection Overuse: 13 million unneeded antibiotic RX US: 10th in life expectancy; 27th in infant mortality NBCH - NHCL

…But We Do Know Following Evidence Can Dramatically Improve Care Peter Lee 11/28/2018 …But We Do Know Following Evidence Can Dramatically Improve Care If care provided nationally AS IT IS to 4 million Medicare beneficiaries, we could save 29% of Medicare spending If all health plans performed at the NCQA’s 90th percentile – over 40,000 lives would be saved each year and over $2 billion 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 NBCH - NHCL

Problem 3: Rising Costs Are Unsustainable for All Peter Lee 11/28/2018 Problem 3: Rising Costs Are Unsustainable for All Projected Spending on Health Care as a Percentage of Gross Domestic Product Percent Source: Congressional Budget Office, 2008 NBCH - NHCL

Health Reform Elements Peter Lee 11/28/2018 Health Reform Elements Major Policy Area Critical Value Policies Coverage expansion and Financing Align public and private policies Connector or Exchange promoting value Benefits 3. Assure core benefits promote affordable “right care”  System Reforms Full measures and public reporting (including release Medicare data) Promote wellness Consumer and provider incentives for shared decisions Payment reform – Change payments AND the decision process  Infrastructure 8. Patient-centered comparative effectiveness  9. HIT that promotes better care 10. Foster innovation NBCH - NHCL

Peter Lee 11/28/2018 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 NBCH - NHCL

Peter Lee 11/28/2018 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 NBCH - NHCL

Peter Lee 11/28/2018 Doing Comparative Effectiveness Right: Big Money, Big Interests and Bad Messaging NBCH - NHCL

Comparative Effectiveness Research: Big Issues Peter Lee 11/28/2018 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 NBCH - NHCL

Peter Lee 11/28/2018 Consumer-Purchaser Principles on Doing Comparative Effectiveness Right: Discussion Draft – May 5, 2009 Public investment: comparative effectiveness research is an important public good that warrants substantial and ongoing public investment Independence and governance: oversight of CER should be as removed as possible from political influence, with processes assuring patient, clinician, purchaser and other input. Total transparency: determination of what to research and the research itself must be totally transparent 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 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) Scope: CER should assess multiple treatment types and interventions 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 Dissemination: results of CER should be disseminated broadly for use by patients, clinicians, researchers and purchasers (and there should not be restrictions on use) Health IT: health information infrastructure should be funded and aligned with CER NBCH - NHCL

About the Disclosure Project Peter Lee 11/28/2018 About the Disclosure Project 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 NBCH - NHCL