Entering a New Era of Evidence

With a busy summer predicted for those involved with health care reform on Capitol Hill, the National Pharmaceutical Council (NPC) brought together key stakeholders to address the issues around the current CER landscape.

Overview

A range of experts at the NPC forum provided important insights on a variety of issues around CER and several themes emerged:

• CER is only one part of health care reform. Speakers and panelists agreed that successful implementation of CER is a key piece of health care reform, but that CER does not “cure” the issues we face in health care. Marc Berger, MD, Vice President, Global Health Outcomes, Eli Lilly and Company, said that our health care system must be an evolving “learning system” that uses CER as a basis for provider/patient-centered decision-making. Eugene Rich, MD, Scholar-in-Residence, Association of American Medical Colleges, challenged the audience to envision a system in which every decision made by a physician is evidence-based. He suggested that, while it is only one piece of reform, it is a critical piece that could transform the way health care is delivered and reduce the tremendous variation that exists today. Marc Boutin, Executive Vice President and Chief Operating Officer, National Health Council (NHC), level-set expectations by asserting that CER will likely do nothing to change health care in the short-term, but that in the long term, a well-implemented approach could help address the 20 percent of the population that is driving 80 percent of the costs.

• Dissemination is key. Dr. Rich noted that CER is necessary, but not sufficient, to transform health care in the U.S. CER can be valuable in creating a strong foundation of knowledge, from which physicians and patients can make decisions. But the challenge has been, and will continue to be, dissemination of that information to patients and providers so that the “right treatment, for the right patient, is delivered at the right time,” noted Boutin. Boutin continued that, for patients with chronic conditions, “best in class” is not always the right treatment for them and that personalized care is needed. Dr. Rich noted that it is critical to send consistent signals to care providers and promote value-based payment reform.

• Generating quality evidence is imperative. Jean Slutsky, PA, MSPH, Director, Center for Outcomes and Evidence at the Agency for Healthcare Research and Quality (AHRQ), emphasized the importance of developing evidence that gets to the key issues. How good is the evidence? How will treatments work in the real world? What are the potential benefits and potential harms and costs? She also emphasized that all evidence needs to be filtered through the needs of patients and their own personal values. Adrian Levy, Ph.D., Director, Oxford Outcomes, discussed international models of CER and highlighted that the key lesson for the U.S. is that incentives must align with providing access and value. He said that simple cost-containment is not achieved through CER.

• CER must be used to improve value, not ration care. Lindy Hinman, Vice President of Federal Policy at America’s Health Insurance Plans (AHIP), noted that, while the health insurance industry feels that cost must be intertwined with CER, the insurance industry’s support of CER is not about rationing care. She explained that the industry is already making coverage decisions, but not always based on evidence. She suggested that CER could help support better decision-making and possibly reduce coverage variation from plan to plan. Additionally, quality research on patient subpopulations could lend to insurance companies’ better tailoring their coverage plans for patients. Boutin said that CER does indeed have the potential to ration care, and because patients with chronic conditions rely on health technology and innovations in care, emphasized the importance of building in mechanisms to ensure patient access. He also noted the role that patient groups have in partnering with manufacturers to bring needed products to market.

• The time is now. Slutsky predicted that the future of CER would be decided over the summer. Indeed, with several pieces of legislation in play right now, policymakers are working to ensure they can meet President Obama’s goal of passing health reform this year. Berger said that the $1.1 billion for CER within the American Recovery and Reinvestment Act is just a “down payment,” and other speakers agreed.

Representative Kurt Schrader, (D-OR), noted growing consensus on Capitol Hill about the need to reduce costs and improve quality. As the sponsor of HR 2502, he reviewed the bill’s key features. He pointed out that the legislation would create transparency, emphasize the physician-patient bond, and ensure all stakeholders are at the discussion table. He articulated that the key goal of his legislation is not to simply rein in over-utilization, but to drive quality. Schrader also outlined his vision of a CER institute that would have a stable funding source, would work with industry to establish standards of research, have clear conflict of interest rules, and would contract out research that would be open to public comment. He said he is optimistic about the chances his legislation will get a public hearing.

Shawn Bishop, senior staffer on the U.S. Senate Finance Committee, shared her insights into the legislative process that supporters of CER are likely to face this summer. She discussed the Baucus-Conrad bill, which has been reintroduced as “The Patient-Centered Outcomes Research Act” to highlight the importance of providing quality research to patients and their providers. She emphasized the importance of having manufacturers involved in the discussion as debate continues.

Dr. Robert Kocher, Special Assistant to the President on the National Economic Council, also emphasized how fast-moving the legislative process is right now and the critical importance of seeking value for patients in all efforts. He suggested that any legislation would likely be continually refined, but that working to build consensus on CER now will create something more promising than the current health care system. He reiterated President Obama’s goal of having legislation ready to sign by the end of the year.