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Ann Thorac Surg 2001;72:1113-1115
© 2001 The Society of Thoracic Surgeons
a Medical Technology Leadership Forum and National Institute of Health Policy, Washington, DC, and HSRP School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA
Address reprint requests to the Honorable David F. Durenberger, Medical Technology Leadership Fourm, 1001 Pennsylvania Ave, NW, Suite 850N, Washington, DC 20004
Presented at the Thirty-fourth Postgraduate Program of The Society of Thoracic Surgeons, New Orleans, LA, Jan 28, 2001.
Opportunity and possibility
The 2000 election has provided us opportunity and possibility for changing the way we think about health policy, including medical technology policy. First, the Republican candidate for President won while firmly gripping the "third rail" of American politics—Social Security reform and Medicare reform. He is willing to put tough health and entitlement issues on the table. That is opportunity for reform.
Second, while we have the first Republican President and Congress in nearly 50 years, the margin is so close we must conclude that there is no mandate for any specific solution. It is counterintuitive but also true that the absence of a mandate provides greater opportunity for change. The way this President is managing education reform provides an interesting lesson. The President has invited the people of this country, not just special interests, to join in the debate. He is allowing Republicans and Democrats to participate in the crafting of solutions in Congress. That makes change a real possibility.
Leadership
Opportunity and possibility will not bring us change without leadership. There are three critical components of a good political leader. First, leaders must define themselves. President George W. Bush is quickly defining himself in ways that create hope, expectation, and possibility. He is making one of the smoothest transitions in recent history, despite a 36-day delay in the election results. Unlike many people we know in political leadership, the President and Vice President give the impression that they are comfortable with themselves, confident of their election commitments, and not concerned about how they might be perceived. The President has also defined his values, including compassion, conservative, civility, community, and nation. His consistency provides the means to the desired end—confidence on the part of the public that they know where their president stands.
Second, a leader relates to our needs. This is a unique gift. President Clinton was by far the best of his time. We must wait for the new President on this one. Third, leaders help define our choices. The course George W. Bush took on the tough issues in his campaign and his actions so far say he is capable of defining America’s choices in ways his predecessors could not.
Definition of the problem
It is essential that we have consensus on the problem before we demand a solution. The Medicare Catastrophic Act of 1988 and the Clinton Health Security Act of 1993 are two examples where the absence of consensus defeated the proposed solution. Before health reform became as partisan as it is today, President Reagan appointed a Commission to reform the Medicare Program. From the Commission recommendations, Congress added a stop-loss financial catastrophic benefit, a prescription drug benefit, and a long-term care benefit. Along with these new benefits was an income test for the wealthiest beneficiaries. Unfortunately, Congress passed the bill without support from all beneficiaries. We worked below the political radar screen and defined the problem in policy terms. The richer beneficiaries did not buy into our definition of the problem and were unwilling to support our solution. Congress bowed to the public reaction and the law was repealed within a year.
In 1993, the Clintons were so focused on designing a complicated solution to the ill-defined issues of access to and costs of health care that they lost touch with how the public perceived the problem. The Clintons spurned the views of Republican reformers and worked almost exclusively with Democrats. As the details of the plan came out, members of the public were concerned that the plan would not solve the problems that they were experiencing. That is why the Health Insurance Association of America’s "Harry and Louise" advertisements struck such a responsive chord. The Health Security Act failed, the President lost both Houses of Congress to the Republicans, and the First Lady retreated from comprehensive health care reform.
On the other hand, there are successful examples from medical technology policy of the value of clarifying the problem. Having heard from constituents that the National Institutes of Health (NIH) had a bias against basic bioengineering research, we drafted and passed an amendment to the reauthorization of the NIH in 1993. The provision required NIH to report to Congress the sum total of its investment in bioengineering and related research, and to offer ways to increase its support for this important area of science. While the NIH delayed the report by over a year, the final product documented that only 3% of their public appropriations went into medical technology and related scientific research. Once the record was clear, Senator Bill Frist then worked to rectify the situation. Various solutions were floated in Congress and in the NIH. During 2000, the radiologists joined the bioengineers to support the National Institute for Bio-imaging and Bioengineering (NIBIBE) in the recently passed budget bill (Beneficiary Improvement and Protection Act or BIPA). President Bush’s budget includes a $40 million appropriation for the new Institute. Without the definition of the problem, as well as the documentation of it back in 1993, the new Institute would not have become a reality.
Understanding the context
For reasons common to all health policy, changing medical technology policy is a greater challenge at the start of the 21st century than ever before. While the aging of the American people is creating unprecedented demographic pressures, the social insurance and other income security policies to support the demand were invented in 1935 and 1965. Long-term care for elderly and disabled Americans is also threatened by rapidly decreasing capacity to meet predictably escalating needs. The globalization of the economy presents enormous health challenges as well as opportunities for American innovation to solve the problems. The public has a greater appetite for the promise of cures than for the ambiguity and uncertainty of scientific breakthroughs and the limits of the art of medicine.
Our health care delivery system as currently constructed is not up to the task. Most of you have come to think the U.S. has the best health care system in the world. We do not. The superiority of many of our individual physicians and the technology at their disposal is being seriously compromised for many of our citizens by over use, under use, and misuse. The sad thing is that the professional leaders of this dysfunctional system appear incapable of providing the vision for a better system. On many issues, health professionals squabble about the allocation of the health care dollar among and between them, and have provided little leadership on such pressing issues as reform of graduate medical education and its funding, the crisis in health professions work force shortages, the price and value insensitivity of patients, and the cost sensitivity of third-party purchasers.
Getting there
Yogi Berra has been quoted as saying, "if you don’t know where you’re going, any road will get you there." It appears to us that when policymakers call for "incrementalism" it is often an excuse for uncertainty about what road to take. We do not have a consensus on goals or strategy necessary to fashion legislative change. Examples of our policy confusion include the Health Insurance Portability and Accountability Act (HIPAA) in 1996 and the Balanced Budget Act (BBA) of 1997. HIPAA was intended to make private health insurance more portable to reduce the number of uninsured. But, the number of uninsured is rising rapidly. It did not even begin to solve that problem, and created many others. The BBA was a collection of catchall proposals, many of which had been debated for years. Many of the cuts are now being restored in the form of "give-backs," with associations contributing money first to prevent cuts and then to get some of the cuts restored. That process looks more like a full employment act for lobbyists and fundraisers rather than incremental steps to an agreed-upon vision for the future.
The medical technology leadership forum (MTLF)
Five years ago, leaders from the medical technology community, including physicians, bioengineers, manufacturers, patient groups, and academic health centers, came together to discuss the challenges of developing good public policy for medical technology. We determined that a small group of leaders could work to learn more about the policy challenges facing this innovative and critically important part of the health care system. MTLF is neither an ivory tower think tank nor a lobbying organization. We identify issues, define problems, and develop policy options, all in order to inform ourselves and then to inform others. As Jack Matloff reminds STS so often, "we need to learn from each other and learn together." STS and Dr Harold Urschel, who serves on the MTLF Board of Directors, are consistent contributors. Over the years, MTLF has designed a variety of meeting types—larger forums, technically focused summit meetings, and informal task force sessions. The MTLF Reports* that are produced have begun to change the way policy makers think about medical technology issues.
Compelling issues for medical technology policy
The overwhelming challenge for medical technology policy is to properly define the problem. As cost pressures continue to rise, increasingly payers and policy makers are defining medical technology as a "cost driver." If technology is a cost driver, then clearly the solution is to force down its costs through draconian price controls and efforts to ration access to them. MTLF has worked to change the definition of the "problem" of medical technology. Policy makers must see medical technology as an important component of quality health care. The policy challenge is not to close down the pipeline of innovation or to drive innovators out of business. The policy challenge is to ensure that technologies that enhance the value of health through improved quality and access and through increased productivity for the health care delivery system succeed. A related goal is to ensure that public policy is proactive and future oriented rather than reactive to the self-interest of small numbers of stakeholders in the system.
MTLF’s Evidence of Value series focused on improving the way that public policymakers seek evidence of value for new technologies and ways in which evidence can be appropriately and systematically developed and fairly evaluated. After two task force meetings, one focused on evidence of value generally and one on Medicare coverage specifically, MTLF issued two reports in 1998: Evidence of Value: Designing a New Paradigm and Medicare Coverage: Time for A Public Policy Dialogue. These papers were distributed widely to key policy makers and were the subject of a dialogue with current and former HCFA administrators and members of Congress in the U.S. Capitol that year. Subsequent task force meetings have focused on specific Medicare coverage reform proposals for Medicare Coverage Criteria (April 1999 and December 2000). In addition, we have held two technical summits on methods, including a look at how to design better ways of gathering information through more flexible options such as conditional coverage of new technologies. Policy makers have praised our clear thinking and cogent presentation. MTLF believes its work on Evidence of Value has improved the quality of the policy debate.
In an effort to be proactive in our thinking, MTLF embarked on a series of explorations of the impact of information technology on medical technology diagnostics and therapeutics, and the policy implications that flow from this exciting confluence of science and technology. In 1999, we held a forum at Stanford University to educate ourselves about the promise and the challenge of information technology and health care. (Priorities and Challenges in Developing Information Technology in the National Healthcare System, September 1999). At Indiana University the following year, we looked specifically at how information technology was changing device therapeutics and diagnostics. (How Information Technology is Revolutionizing Medical Device Innovation: Implications for Medicine and Public Policy, July 2000). At Duke University in February of 2001, our conference, Reimbursement for Clinical Information Technology, focused exclusively on the policy implications of these innovations. Embedding information technology on implantable, hand-held, and hospital-based technologies has the potential to revolutionize care. It also confronts some of the traditional payment paradigms and the conventional views of physician-patient relationships. We have also looked at other consequences of information technology and device innovation, including the privacy issues that arise when devices are integral sources of patient information. Our report, Patient Confidentiality: An Examination of the Issues and Their Impact on the Development and Use of Medical Technology, has been widely circulated in Washington as the Bush Administration struggles with a redesign of the former Administration’s privacy regulation.
This year we are embarking on a new theme—conflict of interest. As public policy begins to focus on protection of patients in clinical trials, medical fraud and abuse, and financial conflict of interest, the environment for innovation at the university and the collaboration between academic and private sector researchers have been impacted. At Stanford University in July of 2001, MTLF will bring together leaders in government, research, and medical practice to explore these issues from a variety of perspectives.
The goal is for MTLF to be a proactive force to identify emerging and potential problems, to work on defining the problems, to study them in the context of the health care research community and the delivery system, and to develop policy analysis and recommendations where appropriate.
Why MTLF matters to STS
Our friend and health policy expert Dr Walter McClure reminds us that "American medicine is remarkably inventive, pointed in the right direction it will steadily raise effectiveness and reduce cost." Each of you and your patients has a stake in improving the quality of health policy, just as you assume a role to improve the quality of medical practice. You must help change the way others think about medical technology, its role in health care practice, and the public policies that affect it. You must also be willing to change the way you think about public policy. President Bush and leaders such as your own fellow surgeon Senator Frist and his many colleagues offer you an opportunity. The Medical Technology Leadership Forum provides the possibility. Together, we can make a difference.
Footnotes
1 David Durenberger served as United States Senator for Minnesota (1978–1994). He has a public policy practice in Washington, DC and chairs the National Institute for Health Policy, a joint program with the University of Minnesota and the University of St. Thomas. He is President of the Medical Technology Leadership Forum. Susan Bartlett Foote is the Division Head and Associate Professor in the Division for Health Services Research and Policy, School of Public Health, University of Minnesota. She is the author of Managing the Medical Arms Race and serves as Policy Director for the Medical Technology Leadership Forum. Contact information: Susan Bartlett Foote, Medical Technology Leadership Forum, 1001 Pennsylvania Ave, NW, Suite 850N, Washington, DC 20004; (202) 661–3580; e-mail: foote003@tc.umn.edu. 
* The MTLF Reports can be obtained at no charge from the Medical Technology Leadership Forum, 1001 Pennsylvania Ave NW, Suite 850N, Washington, DC 20004.
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