Evidence-Based Medicine Comes to Washington
By Edward G. Connette, Essex Richards, PA, Charlotte, NC
With a recession sweeping the country, Congress and the Administration went looking for shovel-ready public works projects to fund with the $787 Billion American Reinvestment and Recovery Act (“ARRA”). Predictably, the money will support state and local government infrastructure projects like roads, bridges and public transit. Buried in the deck is a wildcard: a $1.1 billion allocation for comparative effectiveness research ("CER") to study what medical treatment modalities work best for which patients, and under what circumstances.
The CER appropriation suggests that Washington has discovered evidence-based medicine. But the objectives of this appropriation differ in some respects from the outcomes that most clinicians seek as they strive to develop and apply best practices.
CER funding could help advance evidence-based medicine, thereby helping community practitioners and their patients. Much of the money will be used to compare the effectiveness of various drugs, medical devices, and a wide range of treatment protocols and interventions. Under ARRA, the Institute of Medicine (“IOM”) has responsibility for recommending priorities for the research to be conducted with the funds. IOM wasted little time in surveying the medical and health policy community to recommend issues to study. Its preliminary report, issued June 30, 2009, lists one hundred research topics, prioritized in quartiles. Topping the list is comparing the effectiveness of treatment strategies for atrial fibrillation, including surgery, catheter ablation, and pharmacological strategies. Further down the list are topics such as comparing the effectiveness of diagnostic imaging performed by non-radiologists and radiologists.
The IOM report notes that "the most important priority of all should be the building of a broad and supportive infrastructure to carry out a sustainable national CER strategy" and that Congress and the DHHS Secretary "must take concerted steps to establish a robust CER enterprise." The American health care system is notoriously decentralized. Perhaps as a result, the industry’s approach to medical research also is fragmented. Pharmaceutical companies seeking FDA approval for a new drug, for example, may focus on proving the safety and efficacy of the drug based on a relatively homogenous patient population. Various public and private agencies and research hospitals may choose to conduct studies to determine how a drug or procedure works within discrete patient subpopulations, which drugs to include in a formulary, quality of life issues, or other factors. Synthesizing data from these diverse sources often is impossible. With the federal government now interested in CER, this may change. Perhaps by coordinating research or developing ways to share data, for example, more may be learned about an intervention's effectiveness among diverse patient populations administered by clinicians in the real world.
The purpose of evidence-based medicine is to help practitioners make wiser decisions. Washington policy makers appear to be interested in additional issues. In addition to pure medical research, the administration will be comparing the relative costs of various treatment options. The Obama administration and others are concerned that the cost of health care is the largest barrier to access. In 2007, Americans spent $7,421 per person on health care, amounting to 16.2 percent of the gross domestic product. Something must be done to control costs, the argument goes, or universal access to care by all citizens will be unaffordable.
While Americans spent $2.2 trillion on health care in 2007, 45.7 million people between the ages of 18 and 65 were uninsured. When these uninsured folks pay for their health care, they pay more than any of us. Too often, they skip preventive care and then pay the full retail or "rack" rates for emergency treatment without the benefit of negotiated provider discount rates. More often, the uninsured cannot pay the cost of their medical care, and their bills remain unpaid. The cost of providing care to uninsured patients is a burden on community practitioners and hospitals.
With this desire to curb medical costs, CER will focus on two troublesome issues: accounting for the financial cost of treatment in comparing effectiveness of different regimens, and limiting the number of treatment options that might be covered by public benefit programs or private insurance. We can expect the research to be used in making coverage determinations by federally funded health benefit programs, such as Medicare, Medicaid, Veterans Administration and the federal employees' health benefit plans. Given the size of these programs, their coverage decisions likely will inform the design and coverage determinations of private employers' group health plans. In the end, the research could be used to deny coverage for some interventions that are deemed too expensive in relation to other options.
CER could shape the agenda for deciding how, and where, to cut health care costs. As a society, Americans appear uncomfortable with making treatment decisions based on cost. Almost unconsciously, many believe that access to health care is a basic human right. Indeed, the recent grassroots opposition to healthcare reform has focused on threats to cutting benefits or rationing care. Current health care reform proposals have raised the specter of “death review panels” and withholding medical treatment. This political landscape will make it difficult for any health plan – public or private – to make coverage decisions.
Other industrialized countries offering universal health care access are more direct in rationing care and making treatment decisions based on cost. The United Kingdom, for example, uses comparative effectiveness data to make coverage decisions. The National Health Service’s Institute for Clinical Excellence collects data to create guidelines for the use of emerging medical interventions. Under their guidelines, if the intervention will cost more than £30,000 per "quality adjusted life year," it will not be covered. As a result, interventions that are available and covered under insured Americans' health plans may not be covered in the UK.
In choosing medical interventions, American patients are accustomed to considering questions of safety, efficacy and effectiveness. Standing alone, CER will not curb the growth in health costs. But CER may force patients and their health benefit plans to ask the additional question, "Is it worth it?" Whether the United States is ready to ask that question, and to live and die by the answers, remains to be seen.
The ABA Health eSource is distributed automatically to members of the ABA Health Law Section . Please feel free to forward it! Non-members may also sign up to receive the ABA Health eSource.