Marthe R. Gold, M.D. M.P.H.
Arthur C. Logan Professor and Chair
Department of Community Medicine and Social Medicine
City University of New York Medical School
Member, Committee on Medicare Coverage Extensions
Division of Health Care Services
Institute of Medicine
Subcommittee on Oversight and Investigations
Committee on Energy and Commerce
U.S. House of Representatives
May 23, 2002
Good morning, Mr. Chairman and members of the Committee. My name is Marthe Gold. I am Logan Professor and Chair of the Department of Community Health and Social Medicine at the City University of New York Medical School and served as a member of the Institute of Medicine’s Committee on Medicare Coverage Extensions. The Institute of Medicine is part of the National Academy of Sciences, a private, nonprofit organization that was chartered by Congress in 1863 to advise the government on matters and technology. The committee report on its findings and recommendations was published in 2000.
My closing comments ("Report Findings") will cover certain conclusions of the IOM report that are relevant to this hearing. I will also draw on my background in cost-effectiveness analysis, clinical preventive services, and patient care as a family practitioner, currently seeing patients in a community health center in East Harlem, in New York City.
It would be lovely if we could live long lives without disability or illness, and slip off softly in our sleep somewhere in our 9th or 10th decade. Second best is to catch illness early, and intervene in a manner that reasonably maintains health and longevity. Prevention supports both of these scenarios. Primary prevention is directed towards averting a health problem, e.g., we immunize to prevent infectious illness, we fluoridate to prevent tooth decay, we stop people from smoking and avoid heart and lung disease. Primary prevention can occur at the population health level -- in communities through public health educational campaigns -- or it can occur in clinical settings. Primary prevention leads us toward scenario one. Secondary prevention is aimed at discovering existing abnormalities before they do us harm; hopefully before they interfere too much with quality of life and life span. We catch cervical cancer early with Pap tests, or decrease the risk of heart disease by lowering cholesterol or blood pressure. Secondary prevention occurs in the medical care setting. Tertiary prevention, in reality a form of treatment, aims to prevent worsening of complications for patients who already have a specific disease. Examples of tertiary prevention include controlling blood sugar in diabetic patients and performing coronary artery bypass grafting on individuals with narrowed coronary arteries to prevent heart attacks.
Medically delivered prevention has been under subscribed in this country. There are many reasons for this, a number of which will have been discussed by others at this hearing, but certainly a major factor historically has had to do with insurance coverage. As insurance coverage has improved through Medicare and other insurers, so has uptake of preventive services. Low income individuals and uninsured persons whose health is known to be poorer and whose life expectancy shorter, have lower levels of uptake of preventive services. We know from the health services research literature that as insurance covers preventive services, more low income persons make use of them.
Although an ounce of prevention is held to be worth a pound of cure, there is always fine print to be read. Preventive interventions, by definition, occur in asymptomatic people. They can cause uncomfortable side effects (e.g. pain or perforation associated with colonoscopy, untoward effects of immunizations); precipitate worry, pain and unnecessary further testing in association with false positive results (e.g., a mammogram detects a mass that after biopsy turns out not to be malignant); interfere with peoples’ self perception by assigning them a disease "label" (people assigned a diagnosis have been found to miss more work post-labeling); and use up financial resources. On a population basis, preventive services should, at minimum, create more good than harm. In addition, they should represent a reasonable investment of resources. Money used in one place is not available for use elsewhere. Certainly the IOM committee was mindful during its deliberations of Congress’s budget rules for itself that require that decisions to increase most types of federal spending be accompanied by explicit decisions to reduce spending elsewhere, or to raise taxes.
Medicare Coverage (and lack thereof) of Preventive Services
Medicare extends coverage to Americans age 65 or over and to some individuals with disabilities or permanent kidney failure. From the outset, the program has focused on coverage for hospital, physician and certain other services that are "reasonable and necessary for the diagnosis or treatment of illness or injury, or to improve the function of a malformed body member" (section 1862 of the Social Security Act.) With certain exceptions, Congress explicitly excluded coverage for primary and secondary prevention and outpatient prescription drugs, among other services. Over the years, selected preventive services have been added on a case-by-case basis through Congressional action.
Given the considerations outlined, sensible policy making would favor that all services that are insured and promoted by Medicare are ones that are known to be appropriate and effective in increasing the health of Americans. This is not currently the case. For example, in 1998, Congress extended Medicare coverage to bone densitometry (to screen for osteoporosis) and in 2000, to prostate-specific antigen (PSA) and digital rectal examination (to screen for prostate cancer) despite evidence-based recommendations by scientific and professional bodies such as the U.S. Preventive Services Task Force (USPSTF), the American College of Physicians, the American College of Preventive Medicine, and the Canadian Task Force on Preventive Health Care. In the case of PSA, for example, the combination of no known survival advantage and the not infrequent serious side effects associated with treatment of prostate cancer, led the USPSTF to specifically recommend against the use of routine screening by PSA. Two studies conducted a decade ago estimated that an initial screening of PSA would cost 6 to 28 billion dollars (Kramer et al, 1993; Optenberg SA and Thompson IM, 1990.)
From the other side, sensible policy would favor Medicare coverage of all appropriate and effective preventive services. This, also is not the case. For example, the USPSTF recommends blood pressure screening, and screening for vision and hearing impairment, depression and problem drinking. In addition it recommends that patients be educated and/or counseled about tobaccos cessation, diet, alcohol, dental hygiene, physical activity, fall prevention and other safety-related issues. None of these are currently covered by Medicare. A 2001 prioritization project that ranked preventive services on the basis of burden of disease prevented and cost-effectiveness placed tobacco cessation counseling and screening for vision impairment among adults aged >64 in the top three services. The report was co-authored by prevention specialists and researchers from the Centers for Disease Control, the Agency for Healthcare Research and Quality, and Partnership for Prevention (Coffield et al, 2001.)
The priorities project ranked blood pressure and cholesterol screening equivalently with vaccination for influenza -- a Medicare covered service. Priority scores for screening for blood pressure and cholesterol were predicated on pharmaceutical treatment of elevations of blood pressure and cholesterol to bring them to normal levels. And yet, as you are well aware, Medicare does not provide coverage for drugs. Low and moderate income individuals are often left with highly treatable risk factors for diseases that they lack the economic wherewithal to control.
Prevention, wisely accomplished, should save pain, mental anguish, and cost. Why then would a public program pay $75,000 (Peigh, 1994) for coronary artery bypass surgery and decline to pay for the smoking cessation counseling and blood pressure and cholesterol lowering agents that would obviate the need for some of these surgeries. Why would Medicare pay for the hip fractures suffered by elder Americans, and not cover the screening and counseling that could substantially decrease the falls that cause the fractures?
Coverage determinations for the Medicare program currently take in a range of considerations, many of them non-aligned. When Congress considers preventive care and other interventions that are now statutorily excluded from Medicare coverage, costs are routinely weighed as part of the decision making. When CMS makes coverage determinations about new technologies that fit under existing categories of covered services, its decisions are not directly governed by the "budget neutrality" rules that Congress has adopted for itself. Instead, CMS applies criteria of effectiveness. These, in turn, are not applied to established technologies and interventions.
Congress has been restrained in its addition of new services to the Medicare package. A major component of the Balanced Budget Act of 1997 was a set of measures intended to slow the growth in program spending and at least delay the date at which Medicare spending is projected to exceed revenues. The cost-accounting that supported IOM committee recommendations on coverage of the services we examined was that used by the Congressional Budget Office, which looks at costs and off-sets over a five year period of time. Often, however, a short time horizon will not permit an adequate evaluation of the long-term costs or savings associated with an intervention. For example, smoking cessation treatment or cholesterol lowering medications may not show their benefit till a decade or two after the intervention has occurred. Formal cost-effectiveness analysis, where the health effects of differing interventions are compared over an appropriate time frame and evaluated along with their costs, provides a truer picture of both the economic and health impacts of medical care.
During the first three decades following the establishment of Medicare, Congress was highly sensitive to issues of clinical effectiveness and cost-effectiveness. For example, at the behest of Congress, the now defunct Office of Technology Assessment (OTA) undertook state-or the-art analyses of the cost-effectiveness of several preventive services. A study of congressional coverage decisions from 1965-1990 identified evidence of favorable cost-effectiveness ratios as one factor differentiating preventive services approved for coverage from those not approved.
The IOM committee strongly endorsed the utility of evidence-based reviews of health services for guiding clinical and policy decisions. For both new technologies and current practices, these reviews help make clear the extent to which there is good evidence about the benefits and harms of a particular intervention. At the same time they highlight important health problems for which good evidence is still missing and point the way toward needed research. Reviews place pressure on clinicians to abandon practices that are clearly not beneficial and to apply and recommend practices that are identified as worthwhile. They support governments and others who pay for care in revising coverage, reimbursement, quality assessment, and related policies to discourage nonbeneficial services and encourage effective care.
The committee also favored more extensive reliance on formal cost-effectiveness analyses for informing coverage determinations. Our point was not that cost-effectiveness analyses should be conducted on all currently covered services Medicare services (a massive task) nor that cost-effectiveness should be the only criterion for coverage decisions. It was, rather, that the status quo coverage apparatus makes it difficult to compare the expected benefits, harms, and costs of different health care decisions. The procedure relied on by Congress for estimating the costs to Medicare of covering a new service -- the one adopted for the report of the committee -- provides an incomplete picture of the value for money of such an action.
The committee’s endorsement of the tools of evidenced-based medicine and cost-effectiveness analysis led it to be strongly concerned by the fluctuating policy support for technology assessment and evidence-based recommendations for clinical practice and coverage policy. Ironically, at a time when the methodology for assessing effectiveness and cost-effectiveness has been strengthened by the health services research community, the coordination of decision making for coverage appears to have eroded.
The committee believed that it is possible to take some steps toward rationalizing coverage policy for preventive and other services. For example, a modest step in this direction would be for Congress to encourage and provide funding support for AHRQ, CMS, and other relevant agencies in preparing evidence evaluations and cost-effectiveness analyses. With respect to preventive services, Congress could direct CMS through the Secretary of Health and Human Services to assess the services recommended by the USPSTF in the context of the Medicare program and to make coverage recommendations. The systematic analyses of the potential benefits, harms, and costs of covering additional services would protect against the piece-meal addition of less valuable services at the expense of more important ones. At the clinical level, this is likely to play out with doctors and other health professionals placing emphasis on higher priority services for their patients.
Enlarging the apparatus for systematic evaluations of the effectiveness and cost-effectiveness of health care interventions and using that information to inform coverage decisions will create a more effective and efficient health care system that will better meet the needs of Americans. For those of us in the prevention community, who have long been troubled by the practice of scrupulously holding preventive interventions to various form of accountability, while leaving many extant interventions unexamined, a more systematic approach to coverage policy would indeed be a breath of fresh air.
Thank you for the opportunity to present these views. I would be pleased to answer any questions.
Coffield AB, Maciosek MV, McGinnis JM, et al. Priorities among recommended clinical preventive services. Am J Prev Med 2001;21:1-9
Institute of Medicine. Extending Medicare Coverage for Preventive and other Services. Field MJ, Lawrence RL, Zwanziger, L (eds). 2000. National Academy Press. Washington, D.C.
Kramer BS, Brown ML, Protok PC et al. Prostate cancer screening: what we know and what we need to know. Ann Intern Med 1993;119:914-923
Optenberg SA and IM Thompson. Economics of screening for carcinoma of the prostate. Urol Clin North Am 1990;17:719-737
Peigh PS, Swartz MT, Vaca KJ, et al. Effect of advancing age on cost and outcome or coronary artery bypass grafting. Ann Thorac Surg. 1994;58:1362-1366