|Thomas G. Dehn, MD, FACR|
Authors Victor Fuchs and Harold Sox, Jr, recently reported on a survey of leading general internists regarding their opinion on the relative importance of 30 medical innovations.1 Their results, published in the prestigious journal Health Affairs, should interest all readers with a penchant for diagnostic imaging technology. Of the 387 internists surveyed, a surprising 73% or 274 responded. Three of the five innovations considered most important were directly related to diagnostic imaging. Together, MRI and CT scanning was considered the most important, balloon angioplasty was third, and mammography was fifth (ACE inhibitors were second and “statins” were fourth). This fall, coincident with the annual frenzy of new product/new technology introduction, it seems appropriate to briefly discuss how innovative technologies are incorporated into practice (diffusion). This discussion is not to be confused with how new products make it to market as the technical and regulatory challenges are truly a world apart. That is to say, a product may be innovative, safe, and even useful (market) but may never see widespread use (practice).
Costs and Benefits
The seminal treatise on the subject remains the work of Peter Neumann and Milton Weinstein entitled “The Diffusion of New Technology: Costs and Benefits to Health Care,” written in 1991 as part of an Institute of Medicine study on “The Changing Economics of Medical Technology.”2 Little has changed in the five principles they cited a decade ago. First, new technologies do, on average, improve the quality of medical care by improving health outcomes. This is not true of every technology in every clinical use, but is true on average. Second, many new technologies are ineffective or redundant and do not improve health outcomes. The trouble is that it is not always easy to discriminate between effective and ineffective technologies at the time they are introduced. Third, new technologies do, on balance, add to health care costs. Some technologies may actually reduce costs by replacing more expensive alternatives or preventing expensive health consequences, but the overall effect is to increase costs. Fourth, the incentives and regulations built into the American health care sector lead to inappropriate diffusion of technologies, both underdiffusion of effective and cost-effective technologies, and overdiffusion of ineffective and cost-ineffective technologies.? Reimbursement systems, professional reward structures, legal considerations, and patient demands all contribute to the problem. The fifth inescapable fact about new medical technology is that the American public cannot get enough of it. We demand the newest and best from our providers, and they are, in general, happy to oblige. Little has changed in the past decade to disprove their hypothesis; in fact, all have now been historically proven.
We are aided in our current consideration by the work of Alan Garber who has recently revisited the subject in his report on “Evidence-Based Coverage Policy.”3 Further, we are fortunate that the principles have been tirelessly championed in the work done by Bruce Hillman and embodied in the American College of Radiology’s research initiative reported in its August 2001 Bulletin.4
It is important that at this point we bifurcate the discussion of technology diffusion into administrative advances and clinical innovations. While they share the common denominator of the need for evidence-based return on investment, the evidence arises from two distinct sources. An individual or group contemplating the purchase of a PACS or new transcription technology cannot expect a public pass-through for payment based on improved clinical outcomes but rather the standard advantages outlined by good business practices. While one can argue that a state-of-the-art PACS improves quality, it would be a challenging sell. In short, try to keep in mind that any purchase of an administrative or clinical support nature should just about pay for itself. Clinical purchases, however, must be supported by evidence-based value.
The Five Theses
Let us therefore review Neumann and Weinstein’s five theses in the light of the past decade of diagnostic imaging experience.
First, new technologies do, on average, improve the quality of medical care by improving health outcomes. Irrespective of cost, this suggests that new clinical technologies have reduced morbidity and/or mortality. We can safely affirm success in this category, recognizing, for example, that while we failed with laser angioplasty, balloon angioplasty coupled with stent insertion has undeniably improved the outcome of a typical patient presenting with large vessel disease. Thermography of the breast did not deliver on its early promise, but improved mammographic equipment and standardization have truly improved quality.
|Table 1. Percent of 71250 isolated chest CT’s without 30-day antecedent chest x-ray.|
Second, many new technologies are ineffective or redundant and do not improve health outcomes. The trouble is that it is not always easy to discriminate between effective and ineffective technologies at the time they are introduced. While the first example cited somewhat validates this point, a more current example might be the use and incremental improvement of PET scanning relative to other modalities. At the time of writing, coverage decisions, essentially absent cost consideration, are generally determined by two prestigious groups. Typically known as “Evidence-Based Coverage Policy,” the most commonly accepted research in the private sector is led by the BlueCross BlueShield Association’s Technology Evaluation Center (TEC), administered in partnership with Kaiser Permanente. In short, the determination “whether an intervention has proven effective for a specific clinical use is now the key to coverage determinations,”5 and they typically impose the burden of proof on the proponents of a new intervention.
Since most of their work involves a meta-analysis, this is particularly challenging due to early-publication bias [inordinately positive, resulting from studies written by principal investigators with an intentional/unintentional bias-enthusiasm]. In the example of PET scanning, there is high-quality clinical evidence of its value in the detection and staging of lymphoma and malignant melanoma, while the evidence is somewhat less clear with respect to other neoplasms. Opinions such as these are then forwarded to the member associations for local review. While in most cases they are uniformly adopted, it is not always the case, as each individual plan has its own decision-making body.
Medicare Gets Involved
While other large health insurers conduct similar endeavors, most piggyback on the work of the TEC group. In the public sector the Medicare Coverage Advisory Group (MCAC) conducts a parallel process. This group was established in 1999 and has been somewhat slow in developing their approach. MCAC has thus far considered less than half of the technologies considered by the TEC group in a single year. At present, most Medicare coverage decisions are made by local Medicare Carriers. Only about a third of all coverage decisions made since the establishment of MCAC have actually gone through the process. The important point is that as you consider purchase of clinical equipment, look not only at the technology but also at the quality of the supporting literature. Heed Hillman’s advice: the most important factor in technology diffusion in the current market is radiology’s contribution to published, sound clinical and socioeconomic research.
Third, new technologies do, on balance, add to health care costs. Some technologies may actually reduce costs by replacing more expensive alternatives or preventing expensive health consequences, but the overall effect is to increase costs. You need only to look at the history of health care cost in the past decade. Despite the remarkable innovations in diagnostic imaging and other disciplines, per-capita health care costs have exceeded the general inflation rate in every year and in some years more than doubled the rate.?
Fourth, the incentives and regulations built into the American health care sector lead to inappropriate diffusion of technologies, both underdiffusion of effective and cost-effective technologies, and overdiffusion of ineffective and cost-ineffective technologies.Reimbursement systems, professional reward structures, legal considerations, and patient demands all contribute to the problem. Our experience at National Imaging Associates (NIA), now working with clients representing more than 5 million covered enrollees, provides data that more than proves this point. Few would argue that CT of the abdomen far exceeds even the most skilled examiners’ senses when presented with patients who have troublesome abdominal pain or malady. Small lesions, nonpalpable nodes, and congenital anomalies are now virtually always apparent upon a patient’s first visit if examined with adjunctive CT. Time is saved and in nearly all cases morbidity and mortality are reduced.
Now take the case of the screening chest CT. Controversial at best, according to the TEC group and the MCAC, the outcomes do not justify either the radiation exposure or the expense. Furthermore, most other health insurance carriers and health policy organizations currently consider chest CT for lung cancer screening investigational (good technology, ineffective use).5 The medical literature documents that helical chest CT is more sensitive than routine chest radiography or sputum cytology for detecting small pulmonary nodules in asymptomatic patients at high risk for lung cancer. However, the false-positive rate of the study is high, and there is no evidence that lung cancer screening with helical chest CT is cost-effective or reduces lung cancer mortality.6,7
The issue has spawned a whole new era of retail radiology, where potential patients, in many cases through subtle innuendo, are induced to pay cash for an as-yet unproven procedure. If this were simply the case, one could build an argument that this overdiffusion is revenue neutral to the system. Unfortunately, it is not that simple. Based on a belief that these studies were being performed and, in fact, billed to the insurers under false pretenses (true overdiffusion), NIA worked in collaboration with several of our client-health plans to assess the extent of possible abuse. The NIA Helical Chest CT for Lung Cancer Screening Provider Profile7 uses claims data to determine the percentage of chest CT scans that were stand-alone noncontrast scans (71250) without evidence of a conventional chest x-ray within the previous 30 days for all major rendering providers. Most readers will agree that these would be suspect as truly representing screening examinations. The following results were calculated for all imaging providers submitting claims for greater than 30 chest CT examinations of all types performed during the study period:
- The number of patients undergoing noncontrast chest CT (71250) who did not have any of the following:
A previous chest CT during the study period
Any other imaging studies done on the day of service
Any antecedent chest X-ray (71000 series code) during the preceding 30 days
- The total number of chest CTs of all types performed
As expected, there has been a substantial increase in the utilization of noncontrast chest CT scanning in the reviewed population during the 1999 to 2000 period.? This coincides with intense public interest in the use of this technology for screening for lung cancer and other abnormalities. (See Table 1; the vertical line indicates the approximate time when the lay press published the data on screening chest CT.)?
|Table 2. Top 50 high-volume providers. Percent of 71250 isolated chest CTs without 30-day antecedent chest x-ray.|
The scattergram depicted in Table 2 shows that at small sample sizes there is some variation between providers due to random events. However, inspection suggests that providers with percentages of 71250 studies greater than 30% to 40% demonstrate a variation in practice that cannot be explained by random variation. Further analysis of the data in Tables 1 and 2 allows us to make the following provider-specific comments: About 20% of all chest CT studies appear to appropriately fall into this category, likely related to chronic fibrotic changes or other known disease while several providers are fraudulently eliciting payment for clinically based disease when, in fact, they are actually doing screening studies.
The fifth inescapable fact about new medical technology is that the American public cannot get enough of it. We demand the newest and best from our providers, and they are, in general, happy to oblige. This decade-old observation needs little amplification as evidenced by the earlier cited chest CT scenario.
When considering an equipment purchase, administrative and practice support technology has to make good simple business sense. When considering purchase of clinical technology, be certain that the preponderance of good-quality, published research supports its value. Finally, when your sales representative quotes the number of studies necessary for an adequate return on investment (ROI), be certain that the projected volume quoted is not based on unsupportable and nonreimbursed overdiffusion of an otherwise proven technology.
Thomas G. Dehn, MD, is executive vice president and chief medical officer, National Imaging Associates Inc, Hackensack, NJ.
- Fuchs VR, Sox HC. Physicians? views of the relative importance of thirty medical innovations. Health Affairs. 2001; 20(5):30-42.
- Neumann PJ, Weinstein MC. The diffusion of new technology: costs and benefits to health care. An Institute of Medicine study. Medical Innovations at the Crossroads. Vol II. Washington, DC: National Academy Press; 1991.
- Garber AM. Evidence-based coverage policy. Health Affairs. 2001;20(5):62-82.
- The value of contributing to clinical and socioeconomic research. ACR Bulletin. 2001;57(8):27-31.
- Helical Computed Tomography (CT) for Lung Cancer Screening for Asymptomatic Patients. A report from the Minnesota Health Technology Advisory Committee. Available at: http://www.health.state.mn.us/htac/ctdr.htm. Accessed October 2000.
- Guide to Clinical Preventive Services (11. Screening for Lung Cancer). Available at: http://text.nlm.nih.gov/cps/www/cps.17.html. Undated. Accessed March 13, 2001.
- Thygeson M. Lead investigator, chest CT analysis, National Imaging Associates, personal communication, June 2001.