The Artificial Heart Prototypes, Policies, and Patients (1991) / Chapter Skim
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7. The Appropriate Use of Technology
7. The Appropriate Use of Technology
Pages 121-134
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From page 121... ...
The past three decades have seen the development of numerous examples of high-technology health care that have yielded important patient care gains. Yet some appear to have been used inappropriately to varying degrees including, in the cardiovascular arena, percutaneous transluminal coronary angioplasty and coronary artery bypass surgery (Cardiology Working Group, 1991~.
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From page 122... ...
Clinical trials and technology assessments help to define what works by determining efficacy, effectiveness, risks, and cost-effectiveness. All of these are important measures in providing quality care or, as the Institute of Medicine (IOM)
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From page 123... ...
First, capital spending for costly equipment is likely to be more constrained than at any time since the Medicare program's enactment in 1965. Tightening limits on revenue from Medicare prospective payment and similar systems of paying for inpatient care on a per-admission basis directly affect the hospital "operating profits" that are a major source of capital-budget funds.
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From page 124... ...
93-641 did not mandate that states require nonhospital facilities (e.g., freestanding diagnostic imaging centers, physician offices) to obtain a CON before acquiring costly technologies, it had only limited impact on the diffusion of costly technologies such as computed tomography scanners and magnetic resonance imaging systems (Hillman, 19861.
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From page 125... ...
WAYS TO PROMOTE APPROPRIATE USE OF MECHANICAL CIRCULATORY SUPPORT DEVICES Because of the cost of implanting a long-term MCSS, this technology is likely to receive at least as much attention from third-party payers, health care providers, and others as any previous technology has received. Even that degree of scrutiny, however, may not suffice to prevent inappropriate use that could have an adverse impact on the quality of care and also increase aggregate health care costs substantially, because of the high perpatient cost.
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From page 126... ...
will represent another means of achieving quality-of-care gains, as will increased levels of scrutiny that can be expected from pretreatment payment authorization programs of Medicare and other third-party payers. Practice guidelines for long-term MCSS use might be developed by the existing Task Force of the American College of Cardiology and American Heart Association that has developed a number of guidelines for the use of cardiovascular technologies; other organizations in the cardiothoracic surgery or cardiology field might also be involved.
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From page 127... ...
It suggests further that appropriate organizations such as the congressional Office of Technology Assessment and AHCPR be charged with conducting such assessments or ensuring that they are carried out. Postmarketing Surveillance Postmarketing surveillance of safety and effectiveness after FDA approval for general use, one aspect of scrutiny of a technology, occurs to a limited extent with both new pharmaceuticals and medical devices but not with new surgical procedures that do not involve specific devices.
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From page 128... ...
A 1990 law requires manufacturers of implanted devices to submit a formal postmarketing surveillance protocol for FDA approval after review by an independent review group. One manner in which routine surveillance can be accomplished is through the use of a patient registry to which physicians who use the device submit data pertaining to specific patients, both at time of implantation and after each follow-up visit.
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From page 129... ...
Patients cannot be required to provide such information but, if the benefits to society at large from their participation are explained adequately, most patients would likely agree to cooperate. Follow-Up Studies Clinical trials of new implantable medical devices typically provide for a two-year postimplantation follow-up period, but this is not long enough, with life-sustaining technologies such as an MCSS, to reveal all possible problems.
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From page 130... ...
Selective Coverage The Medicare program and several third-party payers in the private sector have developed selective coverage programs applicable to heart transplantation and other high-cost technologies, in effect an extension of the physician credentialing concept to the hospitals in which they practice. These programs achieve a quality-related goal by limiting payment for technology use to specific institutions, sometimes referred to as "centers of excellence," that meet explicit staffing requirements and can document experience (e.g., patient volumes, specific minimum survival rates)
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From page 131... ...
Certainly, the clinicians and researchers involved in developing MCSSs and in clinical trials are important participants in guideline development because of their intimate knowledge of the devices' impact on patient care. Other less obvious participants should include other physicians and allied health professionals, personnel from NHLBI's artificial heart program, representatives of third-party payers, health services researchers, economists, ethicists, and either MCSS patients themselves or others (e.g., family members, caregivers)
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From page 132... ...
MCSS developers and clinical trial investigators have a particularly difficult task ahead, as trials of longterm devices begin. The privacy of patients and their relatives must be respected, but somehow balanced with the public's interest in each patient's day-to-day progress.
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From page 133... ...
The timetable for MCSS development does, however, permit other sectors of the health care community to respond to the concerns and suggestions expressed here. Ample time exists before the first model of a long-term VAD goes into wide use in the late 1990s, and the TAH in perhaps 2005 or 2010, to formulate and implement mechanisms that promote appropriate MCSS use and reduce the likelihood of inappropriate use.
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From page 134... ...
1989. Heart transplantation may not improve quality of life for patients with stable heart failure.
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