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Invention to Practice
EDITORIAL
Invention to Practice Bruce J. Hillman, MD You never change things by fighting the existing reality. To change something, build a new model that makes the existing model obsolete. —R. Buckminster Fuller
The advance of medical imaging technology over the past 30 years has been extraordinary. Innovations such as computed tomography, magnetic resonance imaging, positron emission tomography, and a host of image-guided interventional procedures have made health care safer and improved outcomes. The continuous arrival of new imaging modalities is overwhelmingly the reason our specialty of radiology has flourished, both intellectually and financially. Most of us who use these technologies in our practices have come to accept the continued development of imaging as our due without much considering where these advances come from and the barriers they encounter on their way to the medical marketplace. I hope that the articles by Raab and Parr in this issue and the 2 succeeding ones will change that. In 3 excellent articles, the authors take us on a remarkable excursion into the Byzantine world of how new imaging technologies gain acceptance in the marketplace, including the roles of assessment, achieving appropriate coding, coverage decisions, and reimbursement. This is required reading for those of us who would better understand why some technologies end up being adopted by our practices while others fall by the wayside. Early in the first article, the one published in this issue, the authors state their principal premise, setting the groundwork for the 3-article series: “Reimbursement shapes med-
ical practice, it creates ‘winners’ and ‘losers,’ and it is complicated.” I agree. Most of us would like to believe that there is more science in it than that, but Raab and Parr present an irrefutable argument to the contrary. For a technology to survive and become broadly adopted, it not only must provide an additional benefit beyond what already exists at a sustainable cost, but it must have the financial and political staying power behind it to weather a protracted period of regulatory approval, credible scientific evaluation, consideration of coding, and payment coverage decisions. This is particularly the case for truly innovative, or what the authors call “breakthrough,” technologies, because they are subjected to greater regulatory scrutiny, may not be adaptable to existing Current Procedural Terminology® codes, and without existing reimbursement face difficulties securing sufficient numbers of adopting providers to be eligible for consideration of reimbursement. Imaging technologies pose special problems. Most notably, as opposed to many devices that have only a single use for a single condition, imaging technologies tend to be applicable to a host of disease processes in a variety of different organ systems. What’s more, we rarely know the extent of the possible use of an imaging modality when it first makes its entrance into practice. That is to say that imaging technology presents a “moving target” for assessment. As Raab and Parr properly point out, it is a real quandary for a manufacturer of imaging devices to decide when to invest in the level of technology as-
© 2006 American College of Radiology 0091-2182/06/$32.00 ● DOI 10.1016/j.jacr.2006.06.008
sessment activities that may be necessary for reasonable consideration by payers. At any given time, the technology may still be progressing in its development, so that it will not perform to the necessary level or its full range of potential applications may not be realized. Once a technology has failed initial evaluation, it may be difficult to overcome negative prejudices, even if further development improves its capabilities. The other side of that coin is that iterative improvements and their marketing may lead to the perception that an imaging device performs better when, actually, the improvement offers little if any patient benefit. It is, in fact, benefit to patients that represents the bottom line for payer decision making. Unfortunately, with regard to new imaging technologies, this may be extremely difficult to determine. In most instances, an imaging examination is only a single node in a chain of diagnostic and treatment steps taken to improve a patient’s health. Even in well-designed clinical trials, it can be very difficult to tease out the role of imaging from all of the other medical procedures in improving health. Because most coverage decisions are made by local carriers, the variable stringency with which these carriers apply the need to demonstrate how an imaging test improves patients’ health outcomes results in considerable heterogeneity in coverage from payer to payer and across geographic regions. Too many adverse coverage decisions means few adopters and the relegation of what might be a potentially useful imaging test to the trash heap. 643
644 Editorial
Some of the statistics offered by Raab and Parr are staggering to consider: 8,000 new medical devices marketed each year, up to 5 years after US Food and Drug Administra-
tion approval to achieve coverage in the Medicare program, 5 billion health insurance claims processed annually. This article and the 2 that will follow in October and November
provide comprehensive insight into a topic of critical importance to radiologists. As always, I look forward to hearing your comments on these articles.
Bruce J. Hillman, MD, Department of Radiology, University of Virginia Health System, PO Box 800170, Charlottesville, VA 22908;e-mail: [email protected].
Invention to Practice Bruce J. Hillman, MD You never change things by fighting the existing reality. To change something, build a new model that makes the existing model obsolete. —R. Buckminster Fuller
The advance of medical imaging technology over the past 30 years has been extraordinary. Innovations such as computed tomography, magnetic resonance imaging, positron emission tomography, and a host of image-guided interventional procedures have made health care safer and improved outcomes. The continuous arrival of new imaging modalities is overwhelmingly the reason our specialty of radiology has flourished, both intellectually and financially. Most of us who use these technologies in our practices have come to accept the continued development of imaging as our due without much considering where these advances come from and the barriers they encounter on their way to the medical marketplace. I hope that the articles by Raab and Parr in this issue and the 2 succeeding ones will change that. In 3 excellent articles, the authors take us on a remarkable excursion into the Byzantine world of how new imaging technologies gain acceptance in the marketplace, including the roles of assessment, achieving appropriate coding, coverage decisions, and reimbursement. This is required reading for those of us who would better understand why some technologies end up being adopted by our practices while others fall by the wayside. Early in the first article, the one published in this issue, the authors state their principal premise, setting the groundwork for the 3-article series: “Reimbursement shapes med-
ical practice, it creates ‘winners’ and ‘losers,’ and it is complicated.” I agree. Most of us would like to believe that there is more science in it than that, but Raab and Parr present an irrefutable argument to the contrary. For a technology to survive and become broadly adopted, it not only must provide an additional benefit beyond what already exists at a sustainable cost, but it must have the financial and political staying power behind it to weather a protracted period of regulatory approval, credible scientific evaluation, consideration of coding, and payment coverage decisions. This is particularly the case for truly innovative, or what the authors call “breakthrough,” technologies, because they are subjected to greater regulatory scrutiny, may not be adaptable to existing Current Procedural Terminology® codes, and without existing reimbursement face difficulties securing sufficient numbers of adopting providers to be eligible for consideration of reimbursement. Imaging technologies pose special problems. Most notably, as opposed to many devices that have only a single use for a single condition, imaging technologies tend to be applicable to a host of disease processes in a variety of different organ systems. What’s more, we rarely know the extent of the possible use of an imaging modality when it first makes its entrance into practice. That is to say that imaging technology presents a “moving target” for assessment. As Raab and Parr properly point out, it is a real quandary for a manufacturer of imaging devices to decide when to invest in the level of technology as-
© 2006 American College of Radiology 0091-2182/06/$32.00 ● DOI 10.1016/j.jacr.2006.06.008
sessment activities that may be necessary for reasonable consideration by payers. At any given time, the technology may still be progressing in its development, so that it will not perform to the necessary level or its full range of potential applications may not be realized. Once a technology has failed initial evaluation, it may be difficult to overcome negative prejudices, even if further development improves its capabilities. The other side of that coin is that iterative improvements and their marketing may lead to the perception that an imaging device performs better when, actually, the improvement offers little if any patient benefit. It is, in fact, benefit to patients that represents the bottom line for payer decision making. Unfortunately, with regard to new imaging technologies, this may be extremely difficult to determine. In most instances, an imaging examination is only a single node in a chain of diagnostic and treatment steps taken to improve a patient’s health. Even in well-designed clinical trials, it can be very difficult to tease out the role of imaging from all of the other medical procedures in improving health. Because most coverage decisions are made by local carriers, the variable stringency with which these carriers apply the need to demonstrate how an imaging test improves patients’ health outcomes results in considerable heterogeneity in coverage from payer to payer and across geographic regions. Too many adverse coverage decisions means few adopters and the relegation of what might be a potentially useful imaging test to the trash heap. 643
644 Editorial
Some of the statistics offered by Raab and Parr are staggering to consider: 8,000 new medical devices marketed each year, up to 5 years after US Food and Drug Administra-
tion approval to achieve coverage in the Medicare program, 5 billion health insurance claims processed annually. This article and the 2 that will follow in October and November
provide comprehensive insight into a topic of critical importance to radiologists. As always, I look forward to hearing your comments on these articles.
Bruce J. Hillman, MD, Department of Radiology, University of Virginia Health System, PO Box 800170, Charlottesville, VA 22908;e-mail: [email protected].