The Inappropriate Appropriateness Argument

Dr. Ron in the last post has done away with the convenience argument, as far as I'm concerned. But don't worry, our friends the self-referrers have more justifications up their sleeves. Even Tim Trysla, head of AMIC, voiced the "Appropriateness" argument when discussing an article by Dr. Jean Mitchell:

We have reviewed the article in Health Affairs on equipment leasing and are hopeful that the author will release the underlying study data so that her peers can replicate her analysis. Since its inception, the Access to Medical Imaging Coalition (AMIC) has worked with policymakers with the goal of ensuring appropriate utilization of medical imaging services. Unfortunately, the Health Affairs article does not offer any data on the appropriateness of the imaging procedures it analyzes -- which is the key to crafting responsible and sustainable policies on access to medical imaging services.

Without having access to the author's data, it is impossible to know if the conclusions she has drawn are reflective of the facts. However, if the arrangements described in the Health Affairs article are in violation of federal or state law, those violations of the law should be prosecuted.

AMIC looks forward to continuing to work with the Congress to enact a reasonable Medicare imaging policy that preserves and strengthens beneficiary access to the right imaging procedure at the right time.

This opens up an ethical minefield, which is mostly controlled by the self-referring clinicians themselves. They are the ones who determine which patients deserve a scan and which do not. These are "their patients" after all, and who are we to second-guess their judgement? If a patient walks in with a headache, should they not be scanned to rule out a subdural? Well??? Bottom line here is that the clinicians win the appropriateness argument, since in a real sense, they set the rules for it.

But wait. This logic can be turned on its head and thrown right back at them.

We know without any real doubt that those with imaging equipment in their offices order more scans than those who don't self-refer. This is pretty much a given. Let's say that they order twice as many studies, which is really underestimating the problem, but that's OK for the moment. AND, let's assume that all of those scans are appropriate. We wouldn't want to question the judgement of our friends, now would we? With me so far? Now, we turn back to the behavior of those who DON'T have scanners in their offices. They are ordering at One-HALF the rate of their colleagues. Therefore, if the self-referrers are ordering appropriately, the non-self-referrers are jilting their patients, not utilizing the life-saving services available right down the street at their local hospital.

The truth cannot fall both ways, can it? Either the self-referrers are ordering inapproriately, most likely due to the fact that they will make a profit doing so, or the non-self-referrers are restricting their ordering inappropriately. One group is harming their patients, and I'll leave it to you to figure out which one that is.

Is something that is convenient always good for you?

A reader named Ron put a comment on the last post, and it is so well-written, I thought it deserved full exposure.

Is something that is convenient always good for you?

Imaging studies are used to confirm a diagnosis and these studies should only be done after a full evaluation by a physician, never before. I find it inconceivable that any physician office could provide an in office imaging service immediately after the physician evaluation without wait. I’m willing to say that there will be either a considerable wait, or a reschedule to come back at a later time to the self referring physician’s office for the exam. If no wait for the exam, I'm sure there will be a wait for the results.

If this was all about convenience, then the same self referring doctors that offer in office imaging would also offer immediate no wait walk-in service 24/7. That would be most convenient for me. It would also be very convenient for me as Dr. Harold states above, to also have available child care and a full hot breakfast or a meal in general available for me when I arrive. In fact, it would be even more convenient for me if the doctor could meet me at my place of work at 5PM when I finish and provide my exam for me there. It would be convenient for him to also bring his mobile scanning equipment with him, just in case I may really need an imaging study. If I needed a specialist from Sloan Kettering, it would be convenient to bring them to his office also.

If this was all about convenience then why did all of the self referring physicians offering in office mammography stop offering the service? For what it matters, my question is why do the same self referring physicians that offer in office imaging not provide the one test that would be of most convenience to women, a mammogram, also in their offices?

Really, how inconvenient is it to make an appointment for a Radiology exam at your local hospital or Radiologist’s outpatient center? Most have after hours and weekend appointments and some could even see you the same day. If you go to your family practice doctor and they feel you need an orthopedic specialist, you make an appointment with the Orthopod and see him wherever his office is when you are scheduled. Why does the self referring family doctor not have an in house orthopedic doctor there for your convenience? What is the difference in convenience to the patient where in town they make an appointment to be seen by a Radiologist; the self referring doctor’s office (no Radiologist) or the local hospital?

Personally, I think it would be worth any inconvenience to be seen where the specialist Radiologist is present, overseeing the center and exams. Where does convenience play a factor when it comes to getting the best medical care by the best trained physicians? You wouldn’t go to the OBGYN to get your brain surgery? Why would you go to a cardiologist to get your Cat Scan of your liver? When you need an imaging study, anything from an Xray to an Ultrasound to an MRI, you want to be evaluated by the specialist, the Radiologist. You want a radiologist who is in town and known to your medical community, not some unknown name half way across the world somewhere reading scans on the cheap for the self referring doctor.

It seems that those with in office equipment have it only for their best paying patients. Those are the ones that seem to need to be less inconvenienced than the rest of us. If you have good insurance, then you are scanned by these self referrers. If you have Medicare, Medicaid, or Tricare (those in society that really cannot afford the inconvenience of the travel expenses etc.) it would be more convenient for you to be seen elsewhere. For the self referring doctor it appears it is convenient for these folks with “bad” insurance to go elsewhere. For patients without good insurance, their convenience is not at issue here.

A physician has a sworn duty to see that his patients get the best possible care irrespective of their insurance. A doctor who is not a trained radiologist who performs radiology exams is doing a disservice to patients in the name of enriching their own bank accounts. Better yet, patients have the right, and the responsibility to themselves to be seen by the best available physician for the job. In the case of imaging, it is the Radiologist. A patient should not feel obligated to help fill the coffers of a self referring doctor, by having their imaging done at his office or the center he gets a kickback from just because that is what he tells them to do.

Patients must always ask their doctor if he has a financial stake in services he offers or performs outside of his professional capacity. (Can you imagine the outcry that would come from surgeons giving money to their referring doctors for sending them patients to do unnecessary surgery on?) If a doctor has a financial stake in doing or sending you for any imaging study then you cannot trust that this study is necessary, that the study is the best study for you, or that it will be performed and interpreted under the direction of a board certified radiologist.

A self referring doctor is not interested in convenience, but rather lining his pockets at the expense of patients and the US health system. Self referring doctors are one of the main causes of increased health care costs. A self referring doctor’s patients will have more unnecessary exams, more poor quality exams, and more poor quality exam interpretations then the patients of other doctors who do not self refer. Patients being seen at the hospital or at a center where there are radiologists will always get better and more cost effective care than at a self referring doctor’s office. At worse, unnecessary exams provided by self referring doctors could lead to serious problems including increased unnecessary radiation exposure, increased unnecessary risk of contrast reactions that could lead to NFS, kidney failure and death. Self referral also has a way of leading towards additional unnecessary studies, unnecessary biopsies and unnecessary surgeries.

Self referring doctors typically have little oversight of their work. Typically their equipment is substandard and most times the people performing the exams are not certified technologists. There is no peer review or accountability for their findings from your exam. Most times, the actual images from the studies and reports are not shared with other physicians. If only the self referrer sees the study and the results and not a board certified radiologist, then who is to know what was missed and if the findings are correct. For patients, are you finding that you are getting additional imaging for the same problems because the self referring doctor got it wrong the first time or because he has a financial interest in you getting more exams?

There is nothing like the convenience of paying out a $5000 deductible and getting unnecessary exams just to make some self referring doctor rich.

Since September of 2006, Harold, the test of time has not proven you wrong. I bet hundreds more cars, boats and McMansions could be added to your list. Self referrers are still laughing all the way to the bank and the amounts of imaging tests and in office machinery is increasing exponentially.

Patients are lining up like rats behind the Pied Piper in supporting these self referring schemes. Insurance companies still seem willing to throw money at these guys. And the government....

Self-Referring Physicians Order More Scans

Jean M. Mitchell, PhD, a professor of public policy at Georgetown University, has written extensively about self-referral, and I have discussed one of her earlier articles in a previous message. Dr. Mitchell has published another article in the journal Medical Care, titled, "Utilization Trends for Advanced Imaging Procedures: Evidence From Individuals With Private Insurance Coverage in California." Apparently mining further information from the data utilized in the earlier article, she concludes:

"Use of highly reimbursed advanced imaging, a major driver of higher health care costs, should be based on clear clinical practice guidelines to ensure appropriate use."

This conclusion seems to be pointed at Tim Trysla's criticism of her earlier article, wherein the AMIC leader questioned her results because she didn't address "the appropriateness of the imaging procedures it analyzes -- which is the key to crafting responsible and sustainable policies on access to medical imaging services."

Since I'm too cheap to pay for the article itself, I'm working from reviews and from the abstract. The results cited by Dr. Mitchell note that PET utilization has increased 400%, while MRI and CT have increased over 50% between 2000 and 2004. But wait, this refers to outpatient imaging! The changes for imaging within hospitals were "small". And for what it's worth, rates were much higher in Southern California than in Northern California.

From a review of the article in the US News and World Report, "The bulk of the increase was seen in patients with private insurance that provided the physician with a fee for service reimbursement."

Well, this doesn't really surprise anyone, does it? We all know what self-referral in this setting is, and what it does, although it is always nice to have the data to back up our impressions.

Commentary about the article from Vivian Ho, PhD, professor of medicine at Baylor College of Medicine, and associate professor of economics at neighboring Rice University, furthers the argument. The review is itself reviewed on the Baylor website. Dr. Ho (DON'T go there) reiterates,

"Increases in utilization rates were substantially higher for scans performed by self-referring physicians than for images that originated from a referral to a radiologist or hospital."

"Physicians seem to choose the self referral option, meaning they do the imaging in their own office, because they are reimbursed by private insurance companies," Ho said. "The other option would be to refer the patient to a radiologist or an outside diagnostic center."

Ho cites other studies of a trend toward manufacturing and marketing cheaper, lower quality imaging instruments. However, the level of reimbursement, regardless of the cost or quality of the equipment used, remains the same.

She writes, "The current reimbursement system lacks incentives to provide high quality imaging in a cost effective manner."

Dr. Ho also addresses the problem of leasing:

"This (leasing) creates revenue for both parties involved," Ho said. "But it also raises a lot of questions such as would it have mattered if another test had been done, one that didn't receive a reimbursement?"

So what to do?

"Unfortunately, the legal system, the method of reimbursing physicians, and our lack of tools to monitor appropriateness of testing have led to significant increases in diagnostic imaging, which likely provide little health benefit to patients."

The solution should involve policy makers, insurers, physicians and health service researchers.

"Only then can we insure that advanced imaging technologies yield a benefit, rather than become a burden to the health care system," said Ho.

I certainly agree with that. But I have to end on a slight sour note. Dr. Ho cautions:

"Doing away with the reimbursements will only penalize those physicians who are actually providing imaging in-office as a convenience to their patients," Ho said.

Now, I have to wonder just what percentage of clinicians actually fall into this category. Probably all of them if they were asked. But really, this argument is getting lamer by the minute. If the docs were so terribly concerned about their patients' convenience, they certainly wouldn't stop at providing services that maybe 5-10% of their patients actually use. Gee, what would I like to see at my doc's office? What about an in-office pharmacy? I'll bet more patients walk out with prescriptions for drugs than a slip to get a CT. How about valet parking? How about a car-wash and dry-cleaning service? The list goes on. The "convenience" excuse is nothing more than rationalization for taking advantage of the loopholes in the system. Period. And someone tell me how sending patients to a scanner leased from some other self-referrer is more convenient. It isn't.

The only answer to the situation is to make absolutely sure that our state and federal governments understand the depth and breadth of the situation, and insist that something be done. Until then, the self-referrers will continue to go about their merry, convenient way.

The NEMA Code of Ethics

NEMA, the National Electronic Manufacturers Association, is an organization of technology companies that includes most of the manufacturers of medical imaging equipment. Their "Code of Ethics" is a long document outlining the sorts of interactions their members should and should not have with health care professionals and institutions in the business of selling things to them. The underlying principle is:

Members shall encourage ethical business practices and socially responsible industry conduct and shall not use any unlawful inducement in order to sell, lease, recommend, or arrange for the sale, lease, or prescription of, their products.

Most of the rest of the document talks about things they can sponsor in the realm of training and so on, and things they can't do, such as take a client to a concert or a golf game. Gifts are a no-no, and hospitality should be "modest," i.e., if they put you up in a hotel, it should be in neither the best nor the worst room available.

This is all well and good, as far as it goes. The problem lies in the fact that there is such a tremendous amount of money to be made on the sale of a scanner, for example, that sometimes the approach is bent a little. Of course, I'm thinking about the scanners sold to those who self-refer. Think about it. Is self-referral an "ethical business practice"? Is selling the 10th MRI scanner in a small town that already has nine others "socially responsible"? I don't think so, personally. I guess it all depends on your point of view, doesn't it?

And "unlawful inducements"? Every scanner manufacturer will be glad to show the self-referrer just how much he can make with their scanner. Yes, I understand that this isn't an "unlawful inducement", but it is going right up to the border of the gray zone.

I'm not quite sure where NEMA's lobbying of Congress as part of AMIC falls in their code, but it seems to have been acceptable to those in charge.

A code of ethics is great so long as it isn't reinterpreted for each particular situation. Is that happening with NEMA? I'll leave that up to you.

"The Politics of Greed"

Eradicator, over on AuntMinnie.com, found an incredible article in ImagingBiz.com, written by Curtis Kauffman-Pickelle, who is "a strategic business consultant to more than 30 imaging centers and radiology practices and CEO of the Imaging Center Institute." Obviously, Mr. Kauffman-Pickelle knows his way around the outpatient imaging world. He decries the "pollution" of this sector by the "dark attraction of greed":

What is difficult to control, however (and extremely difficult to train salespeople to penetrate), is the political referral that clearly falls within the category of an expected quid pro quo: I will send you my scans if you give me something in return.

Kauffman-Pickelle goes on to describe the ways in which unscrupulous operators will go around the law and regulations trying to bribe their way into a full schedule. He goes on to say,

Back to the fundamental question: How do you compete with this greed?

You don’t. Greed is as old as civilization itself, and money—as a manifestation of this one of the seven deadly sins—has been changing behavior and sinking people for centuries.

What ethical and honest businesses need to do is rise above the temptation, knowing that those operating sleazy businesses are really in the minority and that they stand a very good chance of being caught and punished; they are not likely to be happy with themselves and their lives, and are not respected members of the medical community. You need to be able to look at yourself in the mirror each day and know that you are helping people, running a clean and effective operation, and inspiring your staff and teammates to achieve success through your leadership. Your ethics, values, and character will win in the long term.

This is good business as well. Never apologize for your success or for making a good living at your chosen craft. You have earned it, and our society is based on the hard work and commitment of entrepreneurs in all kinds of professions, including medical imaging. Don’t be distracted by those who seem to be getting away with illegal behavior. You really would not want to trade places with them, so leave them to their own devices.

This is of course very good advice, and an excellent analysis. I would carry it over to the problem of imaging self-referral, which is really the same sort of greed-based pursuit of money as described above.

Mr. Kauffman-Pickelle's approach makes sense for those who are of high moral and ethical fiber. Naturally, they are not going to lower themselves to borderline or overtly illegal activities to make an extra dollar. Sadly, those who do participate probably don't care. I would have to disagree with the author about the perpetrators being unhappy and not respected in the community, at least as far as physician self-referrers are concerned. They are happy as clams, wallowing in their ill-gotten gains. They feel completely immune from penalty, that they deserve every cent. Very few of their colleagues care about the source of the revenue in the least; they are only envious of the parade of Mercedes and BMWs and the other swag flaunted by those who abuse the system.

This is why the government will eventually have to step in; there isn't much self-policing going on here. The politics of greed rule.

There ARE Some Ethical Docs Out There

You might think from reading this blog, as well as any other media source, that many doctors are greedy S.O.B.'s, trying to make an extra buck anywhere they can. While that might be true in some cases, there is a growing movement away from such avaricious behavior.

Gina Kolata, writing in the New York Times today, notes a trend of doctors rejecting pay from industry. It seems that several very prominent physicians have sworn off the dole from pharmaceutical companies and the like.

The scientists say their decisions were private and made with mixed emotions. In at least one case, the choice resulted in significant financial sacrifice. While the investigators say they do not want to appear superior to their colleagues, they also express relief. At last, they say, when they offer a heartfelt and scientifically reasoned opinion, no one will silently put an asterisk next to their name.

They are part of a group responding to accusations of ethical conflicts inherent in these arrangements, and their decisions repudiate decades of industry influence, says Dr. Jerome P. Kassirer, a professor at the Tufts School of Medicine, who has written a book on conflicts of interest. . .

(Kassirer) attributes the change to publicity about conflicts and what can be almost a public shaming when researchers’ conflicts are published. “Finally, it’s gotten to people,” Dr. Kassirer said.

Well, if that's what it takes, maybe we need to provide a public shaming for our self-referring friends. How about taking out an ad in every newspaper in every major city (or maybe just one big one in USA Today) listing every self-referring physician that owns his/her own imaging equipment? Of course, the case has to be made in the introductory paragraphs that this is a bad thing. The convenience arguments and so forth have to be destroyed before they are even uttered. People have to be made aware of what is really happening. No doubt they will be angry when they finally understand.

The NYT article does give me hope that the self-referrers (and the radiologists that read for them) can be made to do the right thing. It would be nice if they all grasped the problem without being forced to do so, but that doesn't seem too likely. Now, who is going to take out that ad?

A Cardiologist "Gets It"

You never know what you will find when you Google "Self-Referral". The list generally includes numerous discussions of Stark laws and CMS rulings.

Today, I stumbled across this very insightful piece from Anthony N. DeMaria, MD, MACC, Editor-in-Chief, Journal of the American College of Cardiology. This would be someone pretty well respected among cardiologists, yes?

At first, Dr. DeMaria pays the usual lip-service to self-referral:

That the increase in medical imaging procedures raises the issue of self-referral should be no surprise. Several studies have demonstrated that diagnostic imaging services are rendered with greater frequency and at greater cost when performed by non-radiologists using equipment in their offices (2). In fact, data suggest that the bulk of the increased use of imaging has been attributable to physicians who self-refer (3). However, it must be recognized that the provision of diagnostic services by attending physicians has many advantages. Many non-radiologists have gained expertise with the imaging procedures in their specialty and have contributed important research findings to advance the field. These specialists can interpret the imaging tests in the context of physiologic and pathophysiologic knowledge of the organ system involved and can integrate the findings with the clinical variables present in any individual patient. The ability to perform an imaging test at the same time and in the same place as the overall evaluation is also an advantage. Thus, although the potential financial incentives of self-referral cannot be ignored, the practice of rendering diagnostic imaging by knowledgeable attending physicians has considerable rationale.

But, he then zeroes in on the problem:

The issue, therefore, is how to maintain the laudable attributes of cardiology practice while guarding against the undesirable incentives of self-referral. In my opinion, at least as a first step, we must acknowledge the potential bias that self-referral can introduce into decision making. It seems foolish to me to just deny that self-referral can have any possible influence in decision-making . . . We ought to guard against providing services for which we have little experience. We invite criticism if we undertake to perform procedures for which we have had little training, scant experience, or very low volumes. We should avoid obtaining equipment for our offices for which there is little demonstrated need or advantage. Given the emerging shortage of cardiologists, there would seem to be little reason to work hard at generating business.

Well, Dr. DeMaria, the problem with your brethren isn't generating business so much as generating income. But Dr. DeMaria concludes:

The recent explosion of medical imaging procedures has again focused attention on the general issue of self-referral in cardiology. Diagnostic imaging has come to play a central role in the management of cardiovascular diseases, and cardiologists have often been responsible for the development and validation of clinical applications. We take pride in the improved level of care that imaging has enabled us to deliver. However, we must remain cognizant of the potential for inappropriate usage inherent in these techniques. The nature of contemporary cardiovascular medicine makes self-referral for imaging and other procedures a natural and advantageous aspect of our practice. It would be tragic if either our application or the perceptions about our application of these procedures resulted in any impediments to their use.

This would be funny if it wasn't so prophetic. Everyone almost lost out on CCTA reimbursement, and that is mainly (although not officially) because CMS was petrified that the cardiologists would abuse it like they have been abusing most of the rest of their toys.

Maybe the solution to the self-referral problem lies in alerting those with some moral authority in the clinical camps to what is happening. But they probably know about it anyway. One lone voice gets lost in the woods, at least most of the time.

Welcome, Aunt Minnie Readers

Looks like someone named eradicator found this blog, and let everyone on Aunt Minnie know about it. Thanks for the promo!

Please read through the posts and see if they make sense to you. I would really like to hear your comments and suggestions as to how we can fight against the problem of imaging self-referral.

Harold

(I'm not going to say much about who I am for obvious reasons. I'm just a guy that thinks self-referral has to stop. That's all.)