Alan Kaye, MD

There is another perspective on the analysis of proposed CMS regulations as described in your article 

CMS plan could take a bite out of teleradiology night reads

, published July 29. 

   The analysis of the regulations correctly states that motivated teleradiology companies will work hard to get their radiologists privileges at a hospital where it has contracted to provide extensive services. It also notes that hurdles to privileging might have the perverse effect of invoking resistance on the parts of hospitals when an incumbent radiology group seeks to obtain outsourced services. 

   But there is a problem with hospitals accepting the credentials of others (The Joint Commission, teleradiology companies, or other hospitals). That approach bypasses normal medical staff oversight. This is inimical to patient care and undermines the security of all medical staff: now radiologists-next, someone else. 

  At a time when there appears to be a reckless attitude on the part of shortsighted hospital CEOs and their boards of directors toward radiology service providers, many consultants and well-known radiologists are appropriately advising radiology practices to make medical staffs their allies. The benefits of these efforts are compounded because the medical staff has a strong role in credentialing. 

  Removing the local oversight of credentialing weakens what are potentially the only allies that patients and radiologists might have. 

  I submit that the benefits of medical staff involvement outweigh the potential disincentives to introducing teleradiology when a radiology practice seeks them out. In fact, the ACR has a policy that states, “The American College of Radiology regards care by onsite radiologists preferable to teleradiology, the latter being most useful as a supplement to onsite care for purposes such as subspecialty consultation and to provide coverage for underserved areas where the physical presence of a radiologist is not feasible.” 

  A decision to introduce outsourced providers to a hospital should be taken very seriously, and hurdles are appropriate. 




Dr. Kaye chairs the radiology department at Bridgeport Hospital, Yale New Haven Health System, in Bridgeport, CT.

Articles

There is another perspective on the analysis of proposed CMS regulations as described in your article "CMS plan could take a bite out of teleradiology night reads," published July 29. There is a problem with hospitals accepting the credentials of others. That approach bypasses normal medical staff oversight. This is inimical to patient care and undermines the security of all medical staff: now radiologists-next, someone else.

Comment: Hurdles to remote credentialing protect radiologists and quality of care

    On Dec. 13, 2007, the Centers for Medicare and Medicaid Services issued a proposed national coverage decision on cardiac CT. Among its provisions was a decision not to reimburse for coronary CT angiography except for two indications, and those only when done within approved clinical trials. 

    The national coverage decision (NCD) supersedes all local coverage decisions by regional Medicare carriers. This decision, among the most restrictive ever issued by CMS, is at once surprising yet understandable. CMS finds itself caught in a dilemma, between technological advancement and fiscal responsibility.   

    We have been performing CCTA in our practice on a strictly referral basis for three years. Our radiologists find the test to be accurate, demonstrating coronary anatomy extremely well. Over these past three years, the literature has corroborated the benefits of the examination. Nevertheless, our referrals are scant, because the cardiologists in our community are loath to adopt CCTA, as they are all imaging modalities that they do not control and for which they do not bill. 

    The literature has also been clear in another aspect of which CMS is surely aware: Economic self-interest frequently dictates referrals for examinations, corroborating our practice’s experience. As has been the case with other cardiac imaging studies, CCTA is especially susceptible to self-referral and its attendant overutilization. If this examination is inappropriately utilized, the economic cost could be catastrophic to our fragile Medicare Trust Fund.  

    Over the past year, the body of data demonstrating the effects of self-referral has been supplemented by several published research studies and comments to CMS regarding other proposed rules. 

    Research by economist Jean Mitchell, a professor of public policy at Georgetown University, on specialty hospitals and imaging showed that investment in hospitals and imaging affects practice patterns. Different physicians in the same region practice differently depending on whether they have ownership interest in the process. The same physicians’ practice patterns changed coincident with their acquisition of ownership interest in specialty hospitals and imaging equipment. 

    A  New York Times  article on Dec. 1, 2006, “Profit and questions on prostate cancer therapy,” described how urologists who get a $40,000-plus “machine fee” for prostate radiation therapy have abruptly changed their patterns of practice. The article quotes Leslie Norwalk, Medicare’s chief administrator, “. . . because of the potential conflicts, urologist-owned in tensity-modulated radiation the rapy is the type of arrangement that Medicare should be watching.” 

    Comments submitted to CMS on the differential use of certain tests suggest that their referral is often tied to the referring physicians’ ownership of the technology. That is, if they don’t own it, they don’t use it. On the other hand, frequently only doctors who own the equipment order the test. Following is one example:  

    The first situation involves an independent diagnostic testing facility providing cardiac PET/CT. This IDTF immediately embarked on a dual business model, leasing time to cardiology groups who would provide services as if the machine belonged to them and the rest of the time acting as an independent provider of the service. Data from three large private payers in the region show the following over the 18-month period through June 2007: 

Two hundred eighteen cardiac PET examinations were done in the entire state by three payers. 

Two of the sites are the two largest hospitals in the state, which own and bill for the examinations done on their scanners. 

A majority-134 of the 218 (63%)-were done at the site where the two cardiology practices  provide services on leased time. These are the only two cardiology practices that have the ability to bill for PET, by virtue of being in the same building. These two practices make up less than 20% of the cardiologists in the stated service area of the IDTF, yet virtually all the examinations in the service area were referred by them, and none was referred anywhere by any of the other cardiologists. Even though they are a small percentage of the cardiologists in the state, they perform nearly two-thirds of the total studies.  

All patients examined at the IDTF’s address were performed by the physicians in those two practices as the providers.  

None of the examinations was billed by the IDTF entity on patients referred by the general medical community. This raises serious questions as to the need for this examination if the other cardiologists never order it from the IDTF. 

One hundred eighteeen of the 134 (96%) were referred by physicians with same tax ID or practice address. This means only six of 134 examinations might have been in non-self-referred category. Even those might have been referred at the suggestion of the cardiologists.  

    Thus, we see the only demand comes from self-referring practices. No other cardiology practices in the area ever order the test, which is readily available at an independent facility.  

    Anecdotes reveal changes in patterns of care before and after acquisition of in-office imaging equipment: If owned, it is used by practitioners  more than it was before ownership. An example of this is shown in Figure 1. 

    Research by Drs. David Levin and Vijay Rao in the  Journal of the American College of Radiology  points out that noncardiac thoracic imaging has shown very little growth in recent years. The authors conclude the reason is that nonradiologists haven’t gotten very involved in doing it (JACR 2007;4[12]:886-889). 

    Another paper by the same authors reports the shift among radiologists from the invasive and expensive diagnostic catheter angiography to safer and lower cost MR angiography and CT angiography. At the same time, the utilization of diagnostic catheter angiography by nonradiologists has increased markedly, thereby allowing them to bill for the expensive, outdated procedure (The effect of the introduction of MR and CT angiography on the utilization of catheter angiography for peripheral arterial disease. JACR 2007;4[7]:457-460). 

    These examples show how economic interest not only increases utilization but also leads to changes in patterns of care based on the economic interest of the referring physicians.  

    The differential growth of imaging by radiologists and nonradiologists is well known to CMS. In addition, a 2007 Office of Inspector General report on the growth of imaging by the various specialties clearly shows that certain specialties are exponentially increasing their billing for imaging procedures. This growth cannot be sustained.  

    CCTA is a test whose dose of radiation to the patient can vary considerably, with higher doses in the range being among the highest of any examination we perform. Responsible physicians, organized medicine, and regulatory bodies must be vigilant about the unfettered proliferation of its use. A recent article in  The New England Journal of Medicine  highlighted concerns about the potential dangers associated with medical radiation from diagnostic tests. While the methodology of the research is in some question, radiologists have always had a healthy respect for the tests we oversee, and we strive for lowest dose and appropriate exams.  

    In reaction to the  NEJM  paper, nonradiologist Dr. Timothy Johnson, the well-known ABC medical commentator, railed against the added utilization that is causing patients to be exposed to potentially damaging radiation by physicians who are not qualified to oversee this machinery and who overorder because they have an economic interest. 

    We frequently see reports of situations in which financial investments by physicians affect their judgment with respect to research and patient care. In January 2008, three such situations were documented in the media. The Office of Inspector General reported that many physician-owned specialty hospitals do not meet Medicare guidelines, with inadequate staffing and substandard emergency facilities and processes. An NBC news report on overuse of coronary intervention was entitled “Conveyor-belt cardiology puts profits first.” On Jan. 30, The New York Time s reported on how spine surgeons participate in clinical studies on the effectiveness of devices in which they have investments.   

    Such is the environment in which CMS must determine coverage for a new and expensive test, and one with a strong likelihood of being billed by the same physicians who order it. Thus, CMS’s decision that coronary CT angiography not be covered at this time is both unfortunate and understandable. The clinical data clearly support its validity. Those of us who know the potential benefits of the test believe that the decision will restrict availability of the procedure  and at the same time retard further refinement of the technique and technological enhancements.  

    On the other hand, those of us who are aware of the situations described, who have seen self-referral thwart patient care and cause undue cost and radiation exposure, understand the underlying dilemma at CMS. That this may be the beginning of an unfortunately restrictive stance on new technology is, perhaps, the most distressing aspect of the NCD.  

    CMS, along with responsible physicians of every specialty, must recognize that we cannot continue to allow the in-office ancillary services exception in the Stark laws, whose huge costs have such an overbearing effect on the advancement of patient care. The cost of in-office imaging is driving decisions on coverage that  impede the development and adoption of innovations to the detriment of patients. 

Restrictions on coronary CT angiographypayments respond to self referral, utilization

CMS decision didn’t  come   out of the blue

A recent move by a market-leading teleradiology services provider may signal the beginning of unstoppable momentum for a disruptive technology, with significant consequences for our specialty. The provider filed a registration statement with the Securities and Exchange Commission for a proposed initial public offering of its common stock.

A "disruptive technology" is an innovation, product, or service that, through a series of cascading events, eventually overturns the existing dominant technology. By contrast, the term "sustaining technology" refers to the successive incremental improvements to performance that are incorporated into an existing product.

The ability to transmit large amounts of data rapidly over great distances is a disruptive technology. Its application to medical imaging data spawned the teleradiology industry, which may turn out to be disruptive or sustaining.

Many of our colleagues harbored optimistic notions that teleradiology would be benign to radiologists because the founders of many of these companies were radiologists. We saw the ability to enhance our lifestyles and provide more timely interpretations as winning solutions for our patients and for ourselves. Some small and rural radiology practices welcomed the access to subspecialty radiologists. These benefits of teleradiology are indisputable.

Even before the birth of the first "wet read" company, however, some radiologists recognized the potential disadvantages associated with teleradiology. One drawback is the disconnect between offshore radiologists and the immediate community from which the images originate. Although teleradiologists may have credible training, they likely do not have the same level of involvement in the medical community and the same degree of commitment to interpretation of all examinations for all patients as do local radiology practices.

Another concern is the potential for bidding wars in response to the search for the lowest price available for preliminary and final interpretations. The provision of intermittent subspecialty overreads to a small hospital requires technology similar to that required for interpretation of all cases, an observation a hospital CEO is likely not to miss. The rapidly proliferating self-referred in-office imaging performed by nonradiologists-permissible under loopholes in the Stark laws and creative permutations in their interpretation-is particularly receptive to bids from low-cost, geographically diverse practitioners.

Because they do not have the same overhead as local radiology practitioners, teleradiology providers charge less than local competition, thereby facilitating the spread of teleradiology ventures and making them more profitable. They also lack the same business considerations, attention to patterns of local care, access to follow-up, or accountability for the clinical consequences of the examinations or their interpretations.

As imaging moves into the crosshairs of payers-both governmental and private-pressure is mounting to reduce its associated costs. During the last presidential campaign, a conversation on "Meet the Press" about the Medicare crisis featured political pundits touting the potential savings from outsourcing radiological interpretations to India.

As more imaging is brokered by nonradiologists and people who have no appreciation for the science provide services that they delegate to others, the imperative to maximize profits will come to the forefront. Independent imaging centers and increasing hordes of self-referrers will also want to maximize profits. Consequently, payers will seek to decrease their expenses. These scenarios promote the evolution of radiological interpretations to become more like commodities that are subject to ready exchange or exploitation within the market.

The Internet has already begun a revolution in many markets: eBay comes to mind. There is no stopping these kinds of disruptions to the status quo, and a commoditized radiology may be no different. Market forces, along with the imperative to reduce costs and the brokering of imaging, will engender a change in the way radiology is practiced.

We can prepare now for imminent change. With the entry of public money and the control exerted by venture capitalists, underwriters, and others, we can expect aggressive and predatory pursuit of market share. As the market for night-time wet reads becomes saturated and the competition heats up, Wall Street managers of these and new companies will turn to supplemental sources of revenues, including daytime reads.

Public teleradiology companies will not be the only predators. Numerous radiologist-owned entities already solicit primary interpretation opportunities from self-referring nonradiologists. Advertisements already appear in general medical management journals from certain prestigious radiology departments offering their services to nonradiologists. They say, "Let us bring world-class imaging to your doorstep. If you are sending your patients down the street, you may be losing potential revenue and inconveniencing your patients." Some also solicit work directly from hospital administrators, essentially striving to displace local radiologists. The entry of Wall Street, however, will ensure a more forceful and pervasive push as the governance includes more savvy and aggressive investor-managers.

If I am correct, the disruptive technology has reached a tipping point. Absent regulatory relief or restriction, we radiologists will have to either compete on price or demonstrate that radiological interpretation is not a commodity and that local radiologists bring value to the process that cannot be accomplished via long-distance communication. Otherwise, we will provide services whose prices are determined by an international wage scale.

A full discussion of the spectrum of potential preparations that radiologists can make to deal with this threat is beyond the scope of this column. Briefly, to avoid teleradiology-induced obsolescence, we must take the following steps to make the disruptive technology a sustaining technology:

- demonstrate our value to the healthcare process, thereby precluding the need for outside assistance;

- create the local capabilities to deliver a product that is better than what can be supplied by the faceless providers;

- become familiar with existing laws and regulations that would serve to limit the operational alternatives of the teleradiology companies; and

- strive to ensure that the legislative, regulatory, and hospital governance environments are favorable to us.

Although teleradiology has many benefits for patients and radiologists, the implementation of the technology is fraught with potentially deleterious consequences for radiology as a profession and business and for patient care. Radiologists accustomed to the protection of an exclusive arrangement with hospitals, a dominant position in their local markets, or other apparent positions of strength should not rest easy. The reaction of incumbent radiologists may determine whether the technology is disruptive or sustaining.

Dr. Kaye is radiology chair at Bridgeport Hospital and president of Advanced Radiology Consultants in Bridgeport, CT.

Alan Kaye, MD

Articles

Comment: Hurdles to remote credentialing protect radiologists and quality of care

CMS decision didn’t come out of the blue

Stock offering signals technology tipping point