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 Physician-Industry Relationships – What Is Appropriate? [21:13m]: Play Now | Play in Popup | Download (185)

The following is a close approximation of a talk DrRich gave to a gathering of some of the world’s most promising young cardiac electrophysiologists, in Nice, France, on June 15, 2010. He was asked to talk to these young physicians about physician-industry relationships. The organizers of this gathering apparently did not know, as anyone who reads this blog would know, that DrRich should never, ever be allowed an opportunity to influence promising young physicians.  But, what’s done is done.

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A worldwide controversy is now roiling over the appropriate relationship between physicians and industry. Superficially at least, this controversy has to do with the undisputed fact that a physician’s relationship with industry can unduly influence his or her behavior.

That is, this controversy is said to be related to the conflicts of interest (COI) that are always inherent, to some degree, in such relationships.

I believe there is a deeper, and far more disturbing, reason behind this controversy, and I will address it in a short while.  But let’s first talk about COI, because it is ostensibly the chief concern, and it is in fact a very important issue.

A COI is present when an individual has a sacred, fiduciary duty (i.e., a duty of trust) to Entity A, but then develops a secondary relationship with Entity B, which (by creating self-interest, competing loyalties, or even just an inability to be objective), threatens to interfere with the primary duty to Entity A.

Physicians, especially academic physicians, have (at various times) at least three primary fiduciary duties that must take priority. These are: a duty to patients when practicing medicine; a duty to students (i.e., actual students, colleagues, or the public) when teaching; and a duty to society (and truth itself) when conducting medical research.  It is clear that ties with specific companies and their products can easily create important COI that may interfere with each of these primary fiduciary duties, and it is equally clear that physicians have commonly allowed this interference to happen.

Far more often than we like to imagine, doctors have allowed bias to creep in when recommending a course of action for their patients, in imparting knowledge to trainees, colleagues or the public, or when designing, analyzing or reporting results of clinical trials. And typically, most doctors who exercise inappropriate bias have convinced themselves that they are really acting in the best interests of their patients, students or society at large. For it is quite difficult to be objective about one’s own COI.

And there is no question that industry has become adept at the gentle art of creating COI among physicians (subliminally whenever possible), and have carefully incorporated the creation of such conflicts into their business models.

Obvious abuses we have all seen include doctors “shilling” for companies or their products at national meetings; clinical guidelines committees seeded with biased members; unbelievable amounts of money (well above “fair market value) being paid to key doctors for consulting services; long advertisements disguised as CME events; and ghost-writing scientific papers, then recruiting prominent physicians to sign on as “authors” after the fact. There are many others.

Such ongoing abuses of our fiduciary duties ought to be deeply embarrassing to us in the medical profession.

And if it’s not embarrassing, it is at least becoming painful. In the US, physicians who are discovered doing some of these things are being called out publicly, being investigated by Congress if not the Justice Department, losing their prestigious academic positions, and having their reputations destroyed. It is hard to be sympathetic toward them.

Despite all the negative attention – both public and legal – that such COI have brought to our profession in recent years, many of us continue to have tin ears.  A recent example, which has caused a stir in the blogosphere if nowhere else, happens to relate to the EP community. (Thanks to Larry Huston of Cardiobrief who did the heavy lifting on this one. )

Recently, the ACC/HRS collaborated in the launch of a new website, called AFibProfessional.org, which is described as “a unique collaboration to address atrial fibrillation for the cardiology community.” The site has only one corporate sponsor – Sanofi, the maker of Multaq.

At the time of launch, all the content on this new website consisted merely of old, recycled material from older ACC and HRS websites, with a single exception. The single exception was a slide lecture by a prominent electrophysiologist, who we all know and love, on “Managing Atrial Fibrillation.”  This lecture makes a strong case for the off-label, off-guideline use of Multaq. The lecture was posted without any COI disclosure statements, though the lecturer, it turns out, has significant financial ties to Sanofi.  When the matter became a public issue, the lecture was pulled from the site, and the ACC promised to investigate. A few days later, the investigation apparently completed to the ACC’s satisfaction, the lecture was reposted, this time with a COI disclosure.

While one hesitates to suggest malfeasance here, it certainly looks bad.  For the ACC and HRS to co-sponsor a brand new website that , by all appearances, is chiefly a vehicle for advertising Multaq suggests, if nothing else, that we in the medical profession, and our professional organizations, still don’t get it. If we don’t police our own COI, it will be policed for us.

What remedy should be applied?  A reasonable approach would be to recognize that physician-industry ties will always bring at least some COI, and to manage the problem by strictly limiting inappropriate COI, and fully disclosing any that remain.

Accordingly, a number of groups – most prominently the Institute Of Medicine – have recently made formal, and tough, recommendations regarding physician-industry relationships. The final “rules” under which we will all have to live are still being negotiated.

But it is highly likely that they will include many if not all of the following:

-    Doctors should not accept any gifts, no matter how small, from industry. These include trivialities such as pens and notepads, and more substantial gifts such as meals and travel.
-    Doctors should not give presentations in which content is controlled or influenced by industry.
-    Doctors should not consult for industry without a written contract, nor should they receive more than “fair market value” for consulting activities.
-    Doctors should not accept drug samples from industry.
-    Doctors who have a financial interest in a product or company should not participate in clinical trials in any capacity that involve that product or company, including patient enrollment, data collection, analysis or reporting.
-    Doctors who have industry ties should not participate in the development of clinical guidelines.
-    Medical schools and professional organizations should not accept direct funding, or attributable funding, for CME.
-    Any interaction with industry will be fully disclosed, and made publicly available.

What this “full disclosure” will look like can be seen in the Physician Payment Sunshine Act, a law which is pending in the US. Under this act,  all “transfers of value” totaling $100 or more in a year to any physician will be reported by each company to the government annually, along with each physician’s identifying information. Such “TOV” includes food, trinkets, entertainment or gifts; travel; consulting fees or honoraria; funding for research or education; stocks or stock options; ownership or investment interest, and any other economic benefit.  This information will be posted on a public, searchable government website. Companies will be fined $10,000 for each incident of an unreported TOV.

You younger physicians will be spending your careers in a COI environment that is significantly different from that which we, your elders, have experienced. Activities that have been acceptable, and even encouraged, will now cause you to be publicly stigmatized, or worse. This matter is in great flux, and you need to pay close attention to it as the rules are changing. In the meantime, you need to choose your interactions with industry very carefully, and very circumspectly.

Everything I have just discussed assumes that the real issue regarding doctor-industry relationships is COI. Indeed, everything I have discussed assumes a particular way of looking at industry relationships, which I will call Theory A. Theory A, goes as follows:

Theory A:

-  Medical progress is Good, and benefits mankind.
-  Industry is responsible for a high proportion of medical progress.
-  Industry-driven progress requires the active participation of physicians.
-  Therefore, a well-managed cooperation between industry and physicians is beneficial to mankind, and ought to be encouraged.

If you subscribe to Theory A you believe that, because well-managed physician-industry relationships benefit mankind, these relationships are good. So, fundamentally, it’s the management of these relationships which is at issue. These beneficial relationships produce unavoidable COI, which we must manage by strictly limiting their extent, and fully disclosing the ones that are left.

On the surface, at least, that’s what the debate is about – where to draw the necessary limits.  But just below the surface, the debate is about something else entirely. Beneath the surface, Theory A is rejected outright.

Today we hear prominent voices telling us that merely managing COI does not go far enough. No amount of COI is acceptable, and ALL physician-industry ties should be prohibited.  Among these is Jerome Kassirer, former editor of the New England Journal of Medicine, who says, “The ideal handling of COI is not to have them at all.” For these voices, Theory A simply does not apply. Rather, (I submit) they subscribe to Theory B:

Theory B:

-    The greed of medical industry creates excessive costs, and produces far more harm to society than good.
-    Physician-industry alliances strengthen industry, and increase the harm.
-    Therefore, crippling these unholy alliances is critical to the interests of society.

A corollary of Theory B is that it can only be the State’s job to cripple these alliances.

Proponents of Theory B, noting, not incorrectly, that medical industry is chiefly concerned with profits rather than the public good, conclude that industry will always behave in ways that are counter to the interests of society.  While many proponents of Theory B will agree that industry provides at least some benefits, they are convinced that these benefits are far outweighed by the harm they produce. Therefore, Theory B proposes to stifle, if not cripple, medical industry. And a very useful strategy for achieving this goal is to de-legitimize any practical relationships whatsoever between medical industry and physicians.

Proponents of Theory B rarely say what their real goal is. Most of them give lip service to Theory A. One must discern their real motives from their behavior.

Much of that behavior, in practical terms, has to do with controlling the flow of information. Let industry develop whatever it wants (perhaps), but don’t let profit-drunk industry – or its greedy physician spokespersons – instruct doctors and patients on who gets to use industry’s products, or when and how.

That kind of information can only be managed by unbiased sources. Proponents of Theory B invariably refer to government-appointed panels of experts to determine which products of industry are good and bad, and to manage the flow of information about them. Information coming from anywhere else is to be regarded as being charged with bias and greed, and should be ignored, or even suppressed.

Inherent in this viewpoint is the notion that the State is an honest broker, with no bias of its own, except to do what is best for the population. The State, in its disinterested beneficence, is the only civil entity which can pass judgment on which medical information is suitable for general consumption.

But even as a general proposition, no government is an unbiased and honest broker. Politics, according to Harold Lasswell, an early Progressive political scientist, is determining who gets what, when and how. Government officials do not cancel their own human nature when they put on a government name tag. As they go about the business of determining who gets what, when and how, they inevitably – and most often intentionally – create various favored constituencies, fiefdoms, and clienteles to suit their own goal. That goal is to consolidate and expand their own authority. In this way, in the exercise of its political mandate the government always creates co-dependencies, and determines winners and losers. So even in the general case, the government cannot be an honest broker.

But with regard to healthcare, government bias goes far beyond the general case. Healthcare spending is the chief problem governments face today. In the US, projected Medicare expenditures over the next 30 – 40 years will be $35-55 trillion. Numbers like this are deeply destabilizing, and simply cannot be abided, and promise nothing but chaos, revolution, and societal disintegration.

To the State, controlling healthcare spending is an existential problem, a matter of life and death, an issue that justifies any solution that has even a slight chance of working.

Why is the cost of healthcare rising so rapidly? Fundamentally, it is medical progress. Medical progress has greatly increased overall healthcare expenditures. Simply consider, for instance, the many fatal illnesses we have converted to chronic, and chronically expensive diseases – coronary artery disease, kidney disease, HIV/AIDS, various forms of cancer, and heart failure, to name a few.  Medical progress has made great strides in early detection and prevention, and preventive medicine always increases the cost of care.  And thanks at least partly to medical progress, life expectancies are on the rise, and people have many more years to consume healthcare.

Medical progress is very expensive, and the more we have of it the more it costs. The State can only look at medical progress and say, “Medical progress is killing us.”

But it is not politically feasible to come right out and say that stifling medical progress is necessary to the survival of the State. Rather, the State must assert that what it is stifling is greed.

Hillary Clinton gave us the State’s operative formulation in 1993: “There are just too many greedy doctors using too much expensive technology.”  So, to control costs, the State must control the doctors; and the State must control the technology, which is to say, industry.

I submit that an underlying theme within the debate over doctor-industry relationships is a desire to greatly slow or even stop the real threat to the State: medical progress, and the vast expenditures which medical progress produces.

The State has several means for stifling medical progress.  The State can institute increasingly oppressive regulations, which can have the effect of hamstringing industry, but more importantly, has the effect of converting industry to a client of the State, dependent on the State’s favors for its success. The State can demonize industry, trying to convince the public that drug companies and medical device companies are evil entities that would just as soon harm them as help them, and indeed, without the strong hand of the State would prefer to distribute pain and suffering as the more favored pathway to windfall profits. But more to the point of today’s discussion, the State can stifle the doctor-industry relationships that are so critical in steering medical progress in a clinically relevant direction.

So the  interests of industry must be represented as being fundamentally counter to the interests of society, and the doctors who have relationships with industry must be painted as their evil (or, at best, deluded) minions.

Yes, industry is biased, and industry will act on that bias whenever they can get away with it. Industry just can’t help itself. That’s just the way it is.

But the State is also biased. And the State will also act on that bias whenever they can get away with it. The State can’t help itself. That’s just the way it is.

Industry will try to exercise its influence over us by data-driven persuasion, and when that fails they will try to sweeten the persuasion, perhaps even with subtle or not-so-subtle bribes.

But the exercise of persuasion is even more dangerous when done by the State. While the State may also try to influence us with data-driven persuasion, it is very quick to resort instead to propaganda (i.e., the art of information-control by which the unwashed masses are told only what the specialized classes have determined is best for them), and when that fails, the State will resort to its ultimate form of persuasion – the enforcement of new and suppressive regulations at the point of a gun.

So, while industry is indeed biased, and needs to be kept at arms length, de-legitimizing industry altogether would be disastrous.  It would create an open field for extraordinarily powerful forces which are at least as biased, but in the opposite direction. If we value medical progress, we need the balance that industry provides – and that includes not only industry’s products, but its voice.

Medical progress driven by industry-physician collaboration is good for mankind. But that collaboration inevitably creates conflicts. We physicians need to control those conflicts, or the collaboration will be forcibly terminated altogether. Our professional history to date is bleak in this regard, and we only have one chance left to get it right, if that.

But in controlling our COI, we should not allow ourselves to be pushed too far. We should agree to reasonable limits on conflicts, and on full disclosure of any conflicts that remain. But we should draw the line when we are urged to forgo all relationships with industry altogether. We must recognize that industry and its selfish goals provide a necessary counterbalance to even more powerful forces whose goal is to stifle medical progress.

I don’t ask that you accept my synthesis of this problem at face value. I simply ask that you listen to what I am suggesting, and observe for yourself what is happening out in the wild. Then challenge yourself to come up with a better explanation for what you see happening out there. I sincerely hope you can, as I would much rather that my conclusions were not true. So if you do come up with a better explanation, I will greatly appreciate hearing about it.

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Now, read the whole story.

DrRich explains it all in, Fixing American Healthcare – Wonkonians, Gekkonians and the Grand Unification Theory of Healthcare.

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 Let Us All Praise Medical Woo [13:35m]: Play Now | Play in Popup | Download (667)

It is quite popular for certain medical bloggers who count themselves as scientifically sophisticated to disparage so-called “alternative medicine.”

Indeed, some have built entire websites to demonstrate (Penn-and-Teller-like) that various forms of alternative medicine – such as homeopathy, therapeutic touch, the medical application of crystals, Reiki, naturopathy, water therapy, bio-photons, mindfulness training, energy healing and a host of others – are completely devoid of any scientific merit whatsoever; are pablum for the uneducated masses; are, in short, irreducibly and irredeemably woo.

These same bloggers are scandalized into virtual apoplexy by the fact that the NIH has funded an entire section to “study” alternative medicine, and worse, that some of the most respected university medical centers in the land now seem to have embraced alternative medicine, and have established well-funded and heavily-marketed “Centers for Integrative Medicine,” or other similarly-named op-centers for pushing medically suspect alternative “services”.

(An astounding list of prestigious institutions of medical science now sporting Centers of Woo is maintained by Orec.)

Until quite recently, DrRich counted himself among the stalwarts of scientific strict constructionism. He was truly dismayed that the NIH and some of our most well-regarded academic centers (under the guise of wanting to conduct objective “studies” of alternative medicine) have lent an aura of respectability and legitimacy to numerous bizarre ideas and fraudulent claims masquerading as legitimate medical practices. To DrRich, such developments were yet another clear and unmistakable sign of the End Times.

Furthermore, DrRich (a well-known paranoid when it comes to covert rationing) saw a more sinister advantage to the official and well-publicized support that government-funded institutions were giving to the alternative medicine movement. Namely, fostering a widespread impression among the unwashed rabble that alternative medicine is at least somewhat worthwhile (and plenty respectable) advances the cause of covert rationing. That is, the more you can entice people to seek their diagnoses and their cures from the alternative medicine universe, the less money they will soak up from the real healthcare system. With luck, real diagnoses can be delayed and real therapy put off until it’s far too late to achieve a useful outcome by more traditional (and far more expensive) medical means.

So, for several years alternative medicine was seen by DrRich pretty much as it is seen by all of the anti-woo crowd – as an unvarnished evil.

But in recent days the scales have fallen from DrRich’s eyes. He now realizes he was sadly mistaken. Rather than a term of opprobrium, “alternative medicine” may actually be our most direct road to salvation. Indeed, DrRich thinks that far from damning alternative medicine, we should be blessing it, nurturing it, worrying over it, in the precise manner that a mountaineer trapped in a deadly blizzard would worry over the last embers of his dying campfire.

What turned the tide for DrRich was a recent report, issued by the U.S. Centers for Disease Control and Prevention, estimating that in 2007, Americans spent a whopping $34 billion on alternative medicine. That’s $34 billion, for healthcare (in a manner of speaking), out of their own pockets.

The implications of this report should be highly encouraging to those of us who lament the impending creation of a monolithic government-controlled healthcare system, and who have been struggling to imagine ways of circumventing the legions of stone-witted, soul-eating bureaucrats now being prepared (Sauron-like) to descend upon us all, doctor and patient alike.

This is why DrRich has urged primary care physicians to break the bonds of servitude while they still can, strike out on their own, and set up practices in which they are paid directly by their patients. Such arrangements are the only practical means by which individual doctors and patients can immediately restore the broken doctor-patient relationship, and place themselves within a protective enclosure impervious to the slavering soul-eaters.

One reason so few primary care doctors have taken this route (choosing instead to retire, to change careers and become deep-sea fishermen, or simply to give up and become abject minions of the forces of evil) is that they do not believe patients will actually pay them out of their own pockets.

Well, ladies and gentlemen, this new report from the CDCP demonstrates once and for all that Americans will, indeed, pay billions of dollars from their own pockets for their own healthcare – even the varieties of healthcare whose only possible benefits are mediated by the placebo effect. DrRich believes that many of the people buying homeopathic remedies are doing so less because they believe homeopathy works, and more because they feel abandoned by the healthcare system and by their own doctors, and realize they have to do SOMETHING. The CDCP report, in DrRich’s estimation, reflects the magnitude of the American public’s pent-up demand for doctors whose chief concern is for them, and not for the demands of third party payers.

Perhaps more importantly, this new report implies that it may be somewhat more difficult than DrRich has thought for the government to outlaw private-sector healthcare activities. As DrRich has carefully documented, a government-controlled healthcare system will require the authorities to make it illegal for Americans to spend their own money on their own healthcare, thus rendering direct-pay medical practices illegal, and putting the final stake into the heart of the doctor-patient relationship.

But the rousing success of the alternative medicine universe will make such laws difficult to enact.

To see why, consider just how encouraging this new CDCP report must be to the third-party payers. Thanks in no small part to the efforts of the government (and the academy) to legitimize alternative medicine, Americans are spending $34 billion a year on woo. This amount indicates tremendous savings for the traditional healthcare system. The actual amount saved, of course, is impossible to measure, but has to be far greater than just $34 billion. Some substantial proportion of patients spending money on alternative medicine, had they chosen traditional medical care instead, might have consumed expensive diagnostic tests, surgery, expensive prescription drugs, and other legitimate medical services. Furthermore, those legitimate medical services (as legitimate medical services are wont to do) often would have generated even more expenditures – by extending the survival of patients with chronic diseases, by identifying the need for even more diagnostic and therapeutic services, and by causing side effects requiring expensive remedies. (While alternative medicine is famous for being useless, it is also most often pretty harmless, and tends to produce relatively few serious side effects – except, of course, for causing a delay in making actual diagnoses and administering useful therapy, but if you’re a payer, that’s a good thing.) So the amount of money the payers actually save thanks to alternative medicine must be some multiplier of the amount spent on the alternative medicine itself.

What this means is that payers (which, let’s face it, will soon mean the government) will be loathe to do anything that might discourage the success and growth of alternative medicine, and this fact alone may stop them from making it illegal for Americans to pay for their own healthcare.

Still, we musn’t be too sanguine about these prospects. Under a government-controlled system, the imperative to control every aspect of healthcare (in the name of fairness) will be very, very strong, and it will be very tempting to the Feds to declare at least some varieties of alternative medicine to be covered services.

But the alternative medicine establishment (bless it) will be largely impervious to government control. Practitioners of alternative medicine are expert at designing vague products and services whose techniques, theories, processes and protocols are fluid, nebulous and ill-defined. So if the Feds declare, say, homeopathy and therapeutic touch to be legitimate, covered services under the Fed’s health plan, why, the alternative medicine gurus will simply come up with entirely new forms of alternative medicine, specifically to remain outside the government plan. (New varieties of alternative medicine already appear with dizzying speed, and can be invented at will. No bureaucracy could ever hope to keep up.)

Therefore, as long as the central authorities depend on alternative medicine as a robust avenue for covertly rationing healthcare, the purveyors of woo will always be able to flourish outside the real healthcare system. And this, DrRich believes, represents the ultimate value of woo, and establishes why we should all be encouraging and nurturing woo instead of disparaging it.

DrRich has speculated on various black market approaches to healthcare which could be attempted by American doctors (and investors) should restrictive, government-controlled healthcare become a reality. But now, thanks to the success of alternative medicine, there is a direct and straightforward path for American primary care physicians to re-establish a form of now-long-gone “traditional” American medicine, replete with a robust doctor-patient relationship, right out in the open – the kind of practice where patients pay their doctors themselves.

Simply declare this kind of practice to be a new variety of alternative medicine. Likely, PCPs will need to come up with a new name for it (such as “Therapeutic Allopathy,” or “Reciprocal Duty Therapeutics”), and perhaps invent some new terminology to describe what they’re doing. But what’s clear is what they will be doing is so fundamentally different from what PCPs will be doing under government-controlled healthcare as to be unrecognizable, and nobody will be able to argue it’s not alternative medicine. In fact, it will seem nearly as wierd as Reiki.

The success of medical woo, in other words, can provide American doctors who want to practice the kind of medicine they should be practicing with the cover they need to do so. And this is why we must support medical woo, and celebrate its continued growth and success.

________________________________

Now, read the whole story.

DrRich explains it all in, Fixing American Healthcare – Wonkonians, Gekkonians and the Grand Unification Theory of Healthcare.

Now on Kindle!

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 Mediating An Electrophysiology Dispute (With Bias) [13:31m]: Play Now | Play in Popup | Download (169)

A minor dispute – and an extraordinarily (almost disturbingly) polite one – has developed between the only two other electrophysiologists, that DrRich knows of at least, in the blogosphere. DrRich, being the third, ought to weigh in – not because his “vote” would break the tie, but because (as always) DrRich knows best.

Dr. Wes started it all off with a post noting, with some degree of dismay, that “(b)oth the Department of Justice (DOJ) and the Recovery Audit Contractors (RAC) are focusing investigations on Medicare billing for implantable cardiac defibrillator (ICD) surgery.”  Wes, with an appropriate degree of paranoia, concludes,”Consider yourself warned, criminals,” then recalls the halcyon days when the prospect of spending time in court conjured up for physicians nothing worse than malpractice suits.

Dr. John M. counters with a post whose purpose is to “welcome the upcoming policing of cardiac device implants.” John goes on to chronicle several examples he has witnessed of physicians implanting ICDs when, clearly, they should not have. The investigations of ICD implants by the Feds – and their private counterparts, the RACs – John posits, will serve to root out the bad eggs.

To his credit, John allows right off that his post is published “at the risk of exposing my naivete.”

To which DrRich replies, “Indeed.”

When DrRich was young, his grandmother, an immigrant from the Old Country who never shed her rustic habits, and not owning a motor vehicle, kept an illegal henhouse in her garage, buying the silence of her neighbors with eggs. It was from her that DrRich learned that if a rooster is behaving badly – engaging in hen abuse, for instance, or perhaps chasing grandchildren around the yard – one does not deal with it by sending Uncle George’s pit bull into the henhouse to take care of the offender. While the nasty rooster (never one to avoid a confrontation) might well be taken down, so would a lot of innocent bystanders.

John, you are laboring under the charming delusion that the purpose of these new investigations is to carefully review ICD implants and tease out only those unethical and/or poorly-trained device implanters, who are clearly and habitually engaging in untoward medical practices. If this were the case, then you and Wes and all those other honest EPs would have nothing to be concerned about, and the audits would indeed make the world a better place.

But alas, DrRich must tell you otherwise.

First, he urges you to read about his own experience. DrRich is a bit older than you, John, and was around the first time the Feds decided to conduct such an “audit” of ICD implantations. DrRich – like you, as pure as the driven snow – was absolutely certain he had nothing to worry about. But as matters unfolded, the fact that DrRich is not today writing this blog from a federal prison (do they let you do blogs in the penitentiary?) is more a matter of luck than anything else.

This new “audit” is much more intimidating than the one DrRich endured. That one was done by the relatively benign Office of the Inspector General (part of HHS). This one is being done by the Justice Department. So if they finger you, you are by definition, as Wes suggests, a criminal.

DrRich has talked about the Regulatory Speed Trap many times. Regulations inevitably become obtuse by evolution if not by design, so that, if you are practicing medicine, it is likely that somewhere – in the hundreds of thousands of pages of indecipherable and self-contradictory Medicare regulations – you are guilty of failing to comply with a regulation somewhere or other, and thus are guilty of healthcare fraud – which is a federal crime. The only thing that likely separates you from a convicted (or, more likely, self-confessed as part of a plea bargain) criminal is that the Feds haven’t decided to “audit” you yet.

The Feds know this, of course. The fact that they know it is documented in a recent GAO report entitled “Improvements Needed in Provider Communications and Contracting Procedures.” The GAO report notes that the bulletins which Medicare carriers are required to send doctors periodically (to make sure they understand the regulations) are filled with dense, lengthy and poorly organized prose sufficient to make them unreadable. Even if they were readable, the GAO continues, these bulletins would do doctors little good since they routinely announce new regulatory policies well after the implementation date, when doctors will already have been guilty of violating such policies (and thus committing fraud). Finally, the GAO finds that when confused doctors contact the Medicare call centers for clarification on the regulations, they get the correct answer only 15% of the time. (Even the IRS does substantially better than that.) And the Medicare websites, required under the regulations to clarify everything for the providers, universally lack “logical organization and navigational tools,” and as a consequence are nearly unusable.

So even when a doctor prospectively asks for instruction on how to comply with Medicare regulations (so as to avoid committing healthcare fraud and incurring huge fines and jail time), nobody is able to give him/her a straight answer. For, while it’s easy to look at a provider’s actions retrospectively (as the auditors are about to do), and find something in the dense regulations that makes those actions imperfect, it’s not so easy to tell providers ahead of time how to navigate those regulations in pristine fashion. As the GAO report reveals, nobody knows how to do that.

Now, DrRich is not calling the DOJ evil. The Feds are not being evil when they set out to conduct audits of physicians’ compliance with uninterpretable regulations; indeed, from their way of looking at it they are being humane.

They are only doing what they have to do, which is find a way – any way – to reduce healthcare costs. In this instance they do not really want to label hundreds or thousands of electrophysiologists as criminals, and ruin their careers and their reputations and their lives. They just want to ruin a few, and make sure the other ones know about it. This limited-bloodshed approach will accomplish their goal, which is, to make all the other electrophysiologists think twice (or thrice) before using ICDs again, in anyone, ever.

But in this instance it gets even worse. With this audit, in addition to dealing with the relatively-restrained Feds, electrophysiologists will also be dealing with the slavering RACs.

The RACs are a fun tidbit brought to us by the Medicare Prescription Drug Act of 2003. Under the RAC initiative, private contractors are to be sent out to perform audits of billing already done by insurers, health plans and physicians. The objective is to find “overbillings,” which the providers will have to repay along with penalties. Further, the act explicitly allows for prosecutions to be brought for “fraud and abuse,” even if the providers have repaid any overbillings.

The purpose of the Recovery Audit Contractors is, well, recovery. During the 3-year pilot of the RAC initiative, which took place in only 3 states, over $300 million were recovered. This wonderful success is the reason RACs are being turned loose elsewhere.

The RACs are paid by commission. Essentially they are bounty hunters, and they get to keep 20% of whatever they collect. According to the Associated Press, hospitals and providers are just a tad worried that these contractors, being so generously incented, will prove a little overzealous in their enthusiasm to find fraud. But worried auditees should not look for sympathy from the public. “A little zealotry is what we’re looking for on the part of the taxpayers,” said Leslie Paige, spokeswoman for Citizens Against Government Waste. “We think it’s about time.” Indeed – everybody can get behind fighting fraud, which is what makes the fraud gambit such a powerful tool for covert rationing.

DrRich surmises that it is good to be a RAC, and thinks you should consider buying stock in these companies, if you can. These outfits are about to harvest the vast bounty of obfuscation that Medicare has been carefully cultivating in its regulations for over 40 years, and has been carefully fashioning as fraud-traps for a somewhat shorter period of time. The RACs see the vast herds of physicians (violators one and all) placidly grazing all across the fruited plains, just waiting to be harvested. Their chief problem will be in pacing themselves; showing some restraint so they don’t use up their resources all at once.

And so, in addition to the dogged, officious, unsympathetic countenances of the lawyers employed by the DOJ, electrophysiologists this time around can also look forward to seeing the leering faces of the RACs’ commission-drunk forensic accountants. Electrophysiologists will experience the worst excesses of both worlds – the excesses of the state, and the excesses of unfettered for-profit outfits.

John M. can welcome this if he wants, and DrRich will wish him the very best good luck. DrRich, though, is still a little shell-shocked 15 years after his own encounter with federal audits of medical practices, and is very glad he’s only a spectator, and not a participant, this time around.

________________________________

Now, read the whole story.

DrRich explains it all in, Fixing American Healthcare – Wonkonians, Gekkonians and the Grand Unification Theory of Healthcare.

Now on Kindle!

Podcast:

 

 DrRich's Global Solution To All Our Problems [8:47m]: Play Now | Play in Popup | Download (65)

Dr. Marya Zilberberg has an interesting post on Kevin,MD, speculating on the effect a worldwide oil shortage will have on healthcare, and what we ought to do about it. Marya is herself a notable blogger who has commented here several times (but whose comments, alas, were among those lost when the catastrophe struck), and she is one of the more thoughtful critics of DrRich. Her criticisms are always fact-based rather than ad hominem, and thus she always gets DrRich to thinking. Her post on Kevin, MD had that typical effect.

So DrRich hopes his readers will give Marya at least a little of the credit for what follows.

We as a nation face several apparently intractable problems at the present moment. Indeed, the problems individually seem so unsolvable that it will obviously take some major “outside of the box” thinking to solve any one of them, let alone the whole mess.

DrRich refers, of course, to the following five problems:

1. We as a nation face more than $50 trillion in debt obligations over the next several decades, thanks to Social Security and Medicare alone. This is an obligation we have no prayer of meeting.

2. Thanks to that massive accumulation of debt, we as a nation are mortgaging our futures to foreign nations, principally China. In fact, this totalitarian power will soon have veto authority on any initiative the US proposes to take.

3. We face an apparently growing threat of terrorist attacks whose base of operations (while it may be insensitive to say so) is in the Middle East.

4. Thanks to our profligate use of oil products, we are causing runaway global warming (and anyone mentioning the past decade of global cooling is a global warming denier).

5. As Marya points out, we appear to be drawing ever closer to a worldwide oil shortage that will threaten every aspect of our lives, even our healthcare.

Marya’s post was the key for DrRich.

DrRich, being a conservative American, has previously subscribed to a “Drill, Baby Drill” sort of philosophy. After all, we have oil in the ground, and we need oil to run our economy – so let’s go get it ourselves, instead of paying all that money to Middle Eastern and Venezuelan dictators, who just turn around and give it to terrorists.

But now DrRich sees the error of his ways.

There is a simple and straightforward solution that addresses all five of our intractable problems, indirectly if not directly.

Here it is: Stop drilling altogether. Leave American oil in the ground. And buy up all those other peoples’ oil (and take physical possession of it) – as fast as we can.

The estimated worldwide oil reserve is about 1 trillion barrels. Let’s buy as much as we can of those reserves, and bring it here. At $100 a barrel that’s only 100 trillion dollars, or only twice what we’re obligated to pay for our old farts over the next few decades. But the difference is, when we spend all that money on Social Security and Medicare, all we’ve got to show for it is old farts who are even older. But when we spend that money buying up the world’s oil, we’ve got a corner on the market.

Where are we going to put all that oil, skeptics might ask? Why, we’re going to store it in the rapidly-depleting Ogallala Acquifer, which is capable of holding up to 978 trillion gallons. The world’s oil reserves, if we choose to follow DrRich’s plan, will be right under Kansas and Nebraska – the heartland.

Even if the price of oil rises to substantially higher than $100 per barrel (which it certainly will as the world’s supplies become sequestered beneath Lincoln and Dodge City), it will still be a bargain for us to buy it up. It will be a bargain at any price. After all, we’re already in a debt hole so deep we cannot possibly get out of it. If we’re destined to perish in a sea of debt, we might just as well drown in $500 trillion as $50 trillion of debt. We’ll be just as dead either way.

So we should be delighted to accumulate whatever amount of debt is required in order to corner the world’s oil market. It’s our only hope.

Because, when the only oil left in the world is American oil, we strike back. Our oil will be a precious, life-sustaining commodity, which nobody in the world can do without. Even if energy technology develops to the point where people can really fly around in airships powered by solar batteries, oil will remain precious. Just try building those solar batteries without petroleum products. Marya herself points out that it’s only petroleum products which allow us to do all the remarkable stuff we do every day in healthcare, as well as in every other modern endeavor.

We’ll be able to charge whatever we want for our oil – DrRich (a humanitarian) is thinking merely $1000 a barrel, as a nice round number. We’ll be able to pay China back, and any other of our debt holders, in a trice. And in another trice they will all owe money to us (like in the good old days).

The Middle Eastern terrorists will become defunded.

Since nobody else in the world will be able to engage in hydrocarbon pollution any longer without our say so, we can control worldwide carbon emissions as we see fit, and “tune” the earth’s temperature like a fine clock.

Best of all, since (according to the current plans of our leaders) the American government will remain permanently in the hands of benign progressives, who by definition care very deeply about the people of the world, all this will be done with the most beneficent of intents, which will assure the very best of outcomes.

Of course, none of this will work if it turns out the world’s oil reserves are vastly greater than current official estimates. This might be something to think about, considering that today’s oil reserves are twice what they were in 1980, even though we’ve burned through (and, of course, spilled) 30 years of oil since then. Thankfully, the experts assure us that this time they’re correct. And if we’re not going to listen to the experts, what the heck are we paying them for?

Besides, given our current situation, we have nothing to lose by trying. So: Cap, Baby, Cap!

________________________________

Now, read the whole story.

DrRich explains it all in, Fixing American Healthcare – Wonkonians, Gekkonians and the Grand Unification Theory of Healthcare.

Now on Kindle!

Podcast:

 

 Even Dermatologists Have Skin In This Game [15:44m]: Play Now | Play in Popup | Download (176)

Recently, DrRich wrote a series of posts detailing how the American healthcare system – even before the new reforms kick in – is taking steps to prevent individual citizens from being allowed to spend their own money on their own healthcare. Part of that effort, of course, is to restrict physicians from offering direct-pay medical services to their patients.

DrRich may have given the impression that only primary care doctors are affected by efforts to restrict their practices in this way. If so, he apologizes.

He particularly owes an apology to his friends the dermatologists. Indeed, DrRich has been reminded of an article that appeared in the New York Times a while back, which castigated dermatologists for the sin of establishing direct-pay practices, and in particular, for creating their own brand of a two-tiered healthcare system – one for patients with skin disorders, and one for “cosmetic dermatology.”

As the Times describes it, patients who wish to see a dermatologist for, say, possible skin cancer are put on a waiting list, and when their appointed time finally arrives (generally several months later) they are subjected to modern medical hell. To wit: Upon arriving in a lackluster office, the patient is shelved for a while in an unattractive, poorly lit waiting room equipped with a broken TV, fuzz balls on the floor, old magazines, the unruly children of other patients, and surly office personnel. Eventually the now-even-more-disheartened patient’s name is called by an indifferent nurse practitioner, who, operating from a checklist of questions, will “triage” her to the appropriate patient-category (e.g., acne, fungus, cancer, warts- you know, dermatology stuff), then have her strip in order to fully expose the large organ (i.e., the skin) for which she has sought assistance, hand her a scratchy yellow paper gown to cover her nakedness, and have her wait for some time in a chilly exam room to see His Holiness, the actual doctor. At last the dermatologist arrives, mutters a greeting (or some other ritual uttering), glances at a clipboard, and announces, “Show me your [acne, fungus, cancer, warts];” whereupon, having regarded the cause of cutaneous concern, and having made a professional determination, he either signs the prescription that has been pre-written for him by the nurse practitioner, or schedules a procedure. Then, placing her bundle of clothing into her arms and wishing her a good day, the doctor shoves her out into the hall to finish dressing, as the formal interview is completed, and the exam room is at a premium.

Presumably, one hopes, some dermatology practices not visited by the New York Times might not be quite so bad. Still, anyone who’s been seen by an American PCP lately will nod sympathetically at the dermatology patient’s ordeal.

Now observe what the Times observes when the patient, instead of having an actual skin problem, merely is sagging here and there and wishes to be shorn up. That is, the patient has a cosmetic issue. That is, the patient wants Botox.

The same dermatologist will often have an entirely different setup for these patients. This time the patient is seen immediately, possibly the same day, as dermatologists are sensitive to the needs of their clients who have an impending public engagement, and thus need to look their best. If this patient is to wait at all, she will wait in a modern, tastefully decorated private room. She will then be seen not by a mere nurse practitioner but by an aesthetician, who will do a careful assessment of the sagging parts, and, aside from suggesting more injection sites than the patient might originally have had in mind, will offer a complete program for long-term cosmetic maintenance, which naturally will include quarterly Botoxification. At just the proper moment the dermatologist comes in, greets the patient warmly and reassuringly; then reviews the recommendations of the aesthetician and discusses those recommendations at length with both the aesthetician and the patient, studying the patient’s face in depth as he does so, pointing, nodding, studying, adjusting, all the while smiling confidently. Yes, he indicates, we will all be very happy indeed with the results. Finally the doctor begins to make the now-thoroughly-discussed-and-agreed-upon injections, doing so with the greatest solicitude and sensitivity. The patient is then given as much time as she needs to collect herself, and is invited to “recover” in a room set aside for this purpose, with flattering lighting, soft music, a cappuccino machine, and perhaps a glass of wine. She leaves the office a new person. And, just as the dermatologist has promised, all are indeed very happy with the outcome.

Naturally, the New York Times is scandalized by the dichotomy which its discerning readers will note here. Why should a patient with a mere cosmetic issue be treated so well, when a patient with an actual medical problem, possibly even skin cancer, is treated so shabbily? How can dermatologists openly encourage such a two-tiered system?

DrRich has a word of advice for the scandalized reporters of the New York Times, and any other concerned Americans who are worried that dermatologists, by setting up separate-but-not-equal practices for their two kinds of patients, are moving us one step closer to the dreaded two-tiered healthcare system we all abhor. That word is: Chill.

Allow DrRich to support this friendly recommendation with two observations.

1) We already have a multi-tiered healthcare system, and little or none of it is the fault of dermatologists. It is the fault of human nature. All countries have at least a two-tiered healthcare system, including countries (like Cuba and China) that have specifically embraced egalitarianism (rather than individual autonomy) as the fundamental operating principle. A second tier is necessary if for no other reason than political leaders and other individuals critically important to the collective effort must have somewhere to go for their healthcare.  The second tier, like the poor, will always be with us.

2) When a dermatologist spends Tuesday afternoon in her run-down office, treating people who come to her for bona fide skin disorders like they’re not really patients but widgets on an assembly line, then spends Wednesday in her other, much more amenable offices, treating the merely cosmetically-challenged like they are minor nobility, she is not really engaging in two-tiered healthcare. Not at all. Instead, on Tuesday she is practicing real, true, prescribed-by-society, by-the-book American healthcare, just as our leaders (in their wisdom) have carefully set it up for us, and on Wednesday she is doing Something Altogether Different.

Injecting Botox is officially and formally not part of American healthcare. How do we know this? Because it is not covered by Medicare or health insurance. If you want Botox you’ve got to pay for it your own self, just as you do if you want a TV or a car. So by all that is sacred, injecting Botox is NOT American healthcare.

Furthermore, when one looks at it objectively, injecting Botox is not even really practicing medicine, at least not in any true sense. In actual truth, it takes very little training or expertise to inject Botox. There’s no reason one must go to college, graduate from medical school, or do several additional years of training in dermatology (or any other specialty) to do this. Anyone with a needle and syringe, an alcohol wipe, and access to Botox could do as well. Just find the wrinkle and stick it. If they made the materials available over-the-counter, most folks would do just fine with it.

The sheer arbitrariness by which injecting Botox is deemed by the authorities to constitute the practice of medicine can also be illustrated by considering a somewhat different, equally well-known cosmetic procedure, one that also involves injecting substances through the skin via needles, and that has much more to do with the actual skin itself than Botox injections (which do not really affect the skin itself, but only the muscles under the skin). DrRich speaks, obviously, of the tattoo. But unlike making Botox injections, tattooing requires real skill, knowledge, training, expertise and artistic talent. Most dermatologists simply could not manage a highly technical skill like that.  The point being, of course, that if you were to describe Botox injections and tattooing to a visitor from Mars, then ask him/her/it which of these two dermatological procedures ought to require a medical license and board certification, the Martian would get it wrong every time.

DrRich understands, of course, that while administering Botox is, in practical and objective terms, no more practicing medicine than is applying an ice-pack to a bruised knee, legally it is indeed deemed to be the practice of medicine. Accordingly, doctors in general (and dermatologists in particular), relying on this nonsensical designation, have legally cornered the market on Botox injections. So it’s not like you could just set up a booth at the Mall and hire high school students to do this (as you can for, say, ear-piercing – which, in contrast to Botox injections, is an actual surgical procedure which is intended to result in a permanent structural change in a body part). If you set up a chain of Botox Booths, you would be practicing medicine without a license, which is a serious crime.

But fundamentally, while performing Botox injections may have a certain legal status, in any true sense it is not really practicing medicine.  Not when ear-piercing and tattooing are not. Rather, in real life, injecting Botox is simply an activity some dermatologists may choose to do when they’re not doing real dermatology.

To say it another way, when the dermatologist goes to her “other office” to cater to a self-paying variety of clientele, she is practicing medicine only from the most arbitrary and strictly legalistic viewpoint. In real life, she is doing Something Else. She is engaging in a Pastime.

Doctors, of course, often have Pastimes. That is, they partake in activities other than practicing medicine when they could, in fact, be seeing more patients. Some have taken up golf. Others have started side businesses such as restaurants or software companies. Some do charity work, or go to graduate school for an MBA. Still others have opted to work part time in order to raise their families.

Society generally finds such activities acceptable, and – to this point – does not insist that all doctors forgo all other human endeavors in order to see as many patients as humanly possible, during all their waking hours. While society seems to be moving closer to declaring that doctors owe this duty to the collective, it has not reached this point quite yet.

Until society sees fit to legislate otherwise (which, DrRich supposes, could happen really very soon now), doctors will continue to spend some of their time engaging in hobbies and business or family activities outside of the formal healthcare system. Some may even leave the formal healthcare system altogether in favor of these other activities. DrRich himself has done this. And until society renders it officially illegal for doctors to do so, DrRich respectfully asks that doctors be left alone to celebrate their individual autonomy as granted to them under America’s founding documents, whether it’s by establishing authentic Indian restaurants, setting up Botox clinics, or even becoming direct-pay practitioners.

One last word of advice for DrRich’s dermatology friends: Have fun with your Botox clinics for now, fellas and ladies, but please don’t become too invested in them.  This is definitely a shallow-moat line of business, and the only thing that gives you any protection at all is your aura as highly trained specialists, with special and secret knowledge about an organ (i.e., the skin) which visibly droops when the underlying muscles become lax with age and gravity. A single action by forces entirely out of your control – say, Congress or the FDA – could render your monopoly entirely moot overnight, and you will be instantly priced out of business by hordes of PCPs, nurse practitioners, Botox booths in Walmart, and even home Botox injection kits. So please remember to at least keep your hand in genuine dermatology, or get your MBA, or perfect your long iron shots, or even learn a real skill, like tattooing – but do something that will provide you with a Plan C. Because Plan Botox is definitely a high risk endeavor over the long term.

________________________________

Now, read the whole story.

DrRich explains it all in, Fixing American Healthcare – Wonkonians, Gekkonians and the Grand Unification Theory of Healthcare.

Now on Kindle!

Richard N. Fogoros, M.D. (DrRich) is a former professor of medicine and a longtime practitioner, researcher and author in the fields of cardiology and cardiac electrophysiology. He currently makes his living as a consultant in research and development with biomedical companies, and as a writer.

In addition to all the fine prose you’ll find here on the Covert Rationing Blog, you can revel in even more of DrRich’s stuff at the Heart Disease site at About.com (which is a New York Times Company, making DrRich one of the few conservative Americans who wishes the NYT great success), and on the “parent” website of this blog, The Grand Unification Theory of Healthcare.

His award-winning book, Fixing American Healthcare – Wonkonians, Gekkonians and the Grand Unification Theory of Healthcare (Publish or Perish DBS, Pittsburgh, 2007), is quite entertaining (for a policy book), has won lots of accolades – and would still be worth reading if President Obama hadn’t come along and solved all our healthcare difficulties with a flick of his pen.

You can reach DrRich by e-mail here:  drrich at covertrationingblog.com

Now that President Obama’s healthcare reform has become the law of the land, it is time for us to prepare ourselves for the real fight. Namely, will individual Americans ultimately be restrained, by law or by subterfuge, from using their own resources to pay for their own medical care?  This notion is not as far-fetched as you might think. In this series of posts, DrRich explores this question, and demonstrates just how far we’ve already come in limiting the healthcare prerogatives of individuals.

Limiting Individual Prerogatives:

Part 1: The Real Fight Is Just Beginning

Part 2: Hillary Started It

Part 3: Breaking the Doctor-Patient Relationship

Part 4: Medicare Already Does It

Podcast:

 

 Medicare Already Does It (Limiting Individual Prerogatives, Part 4) [12:33m]: Play Now | Play in Popup | Download (32)

Part 1 of Limiting Individual Prerogatives

Part 2 of Limiting Individual Prerogatives

Part 3 of Limiting Individual Prerogatives
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DrRich could go on and on about how our government is intent on restricting the right of individuals to spend their own money on their own healthcare, but (for now, at least) this will be the final post in this series. DrRich has made his point.

Even some of his critics, who have accused DrRich in the past of being overly paranoid on this topic, seem to have gotten it. Some who previously were quite vocal have remained suspiciously silent. Others have fallen back to quasi ad hominem accusations (suggesting, for instance, that DrRich must be a follower of Mr. Beck, with all the horrific connotations that condition entails). And then there is the esteemed Praveen (author of the excellent True Cost Blog), who conceded as follows: “Massachusetts’ attempt to ban direct pay is both unfortunate and unconstitutional. Perhaps you’re right, and the bureaucrats are sneakier than I think.”

So maybe DrRich should just declare victory and move on.

But it is important to make one final point, namely: the notion that our government is intent on limiting our individual healthcare prerogatives is far more than just one of DrRich’s theoretical constructs. Indeed, our government has been acting on this intent for over 15 years. The main case in point, of course, is Medicare.

It has always been recognized that every American citizen “is the proper guardian of his own health,” (Supreme Court Justice Joseph Story, 1873), and accordingly, has a natural right to employ his own individual resources to that end. Roe v. Wade, for instance, was a particularly explicit recognition that a woman has a fundamental right to purchase medical services which she determines to be necessary for her own well-being.

Indeed, when Medicare became law in 1965, Congress also explicitly recognized this right, stipulating that nothing in the new law “shall be construed to preclude [an individual] from purchasing or otherwise securing protection against the cost of any health services.” (DrRich reminds his readers once again that a bold, restrictive statement like this, appearing in legislation, generally heralds an outcome opposite to the statement itself.)

DrRich has already pointed out that under Hillarycare, private medical practice would have been nearly criminalized out of existence. So one ought to expect that the Clinton administration would view an individual right to purchase healthcare as a threat. And indeed, it did. But, as it happens, the erosion of the rights of Medicare “beneficiaries” began even before the Clinton administration. (And even again, DrRich must remind his readers that any universal healthcare plan, even under a Republican administration, will always tend to limit individual liberties.)

In 1991, Medicare administrators published a “carrier bulletin” warning physicians that direct-pay contracts between patients and doctors were strictly prohibited, unless the contract was initiated solely by the patient, and even then, payment rates must be set by Medicare, and further, if the patient later became dissatisfied with that (patient-initiated) contract, Medicare would severely (and retroactively) sanction the physician.

When physicians sued Medicare to prevent this odious new policy from being implemented (Stewart et al. v. Sullivan), the government took the position that it had, in fact, not made any new policy after all, arguing that stuff that shows up in its “carrier bulletin” doesn’t really count. But once this argument was successful in having the lawsuit thrown out in a summary judgment in 1992, Medicare then cynically turned around and immediately made that selfsame new policy “official,” by publishing it in their 1993 Medicare Carrier’s Manual.

But the Feds were still not satisfied. The new, restrictive policy technically still allowed private-pay contracts, as long as the patient initiated them. So the Clinton administration engineered an amendment to the Balanced Budget Act of 1997 – Section 4507 – which prohibited any self-pay contracts whatsoever between Medicare patients and their doctors for medical services which are covered under Medicare. Under Section 4507, which is still the law today, if a doctor provides even one self-pay medical service to a single Medicare patient, that doctor is punished by complete banishment from the Medicare program for at least two years.

The federal government was eventually challenged again in court over Section 4507, but that lawsuit was also thrown out in a summary judgment. The rationale the government offered to the court in justifying its restrictions on individuals’ prerogatives, however, is instructive: “…what you will have is a system whereby the rich can buy what they want and those many beneficiaries who are on fixed income will not be able to afford those services” (United Seniors Association et al. v. Shalala). So again, the interest of the collective (“social justice”) was invoked to justify a law which stifles an individual’s fundamental right to purchase medical services he or she determines to be necessary for his/her well-being.

In any case, since 1997 Medicare patients have been able to purchase Medicare-covered services for themselves ONLY if they obtain that service from a doctor who agrees to opt out of Medicare entirely. This severely limits a patient’s opportunity to self-pay for covered services. The fact that Medicare patients can still buy these medical services from direct-pay physicians, however, is one reason the government hates direct-pay practices, and wishes to stamp them out. More importantly, while some primary care physicians have indeed opted out of Medicare in order to establish direct-pay practices, this path is not a realistic option for medical specialists. So in practical terms, the only “covered services” available for self-pay by Medicare patients, on even a limited basis, are primary care services.

There are several legitimate reasons a Medicare patient might want to self-pay for a medical service that is covered by Medicare. If Medicare “covers” heart valve surgery, for instance, a patient might want to pay for a new, minimally-invasive surgical approach that is inadequately reimbursed by Medicare, rather than the big, open-heart surgery that Medicare reimburses fully. Or, one might want to self-pay for “covered” psychiatric care, or for treatment for a venereal disease, in order to keep embarrassing or harmful medical records out of government-controlled databases.

Furthermore, it is important to recognize that just because a healthcare service is “Medicare-covered” does not mean that it will be covered for a given patient. Whether a specific individual is covered is often determined by a “medical necessity” ruling, made by a bureaucrat. Section 4507 essentially precludes a patient’s ability to purchase a denied (but “covered”) medical service, no matter how badly they want it, or believe they need it.

One can argue, and with some merit, that at this juncture denials of medically necessary services by Medicare have been relatively judicious, and therefore that the “Section 4507 rule” has not had much of an actual impact. In fact, it is likely that most Medicare beneficiaries do not even know that this rule exists.

But while its impact might be relatively small so far, the Section 4507 rule has now been in place for 13 years – it is well-established. So, once Medicare begins reducing reimbursements to physicians and hospitals, to the point where they can no longer afford to offer certain services to Medicare patients (and Medicare has just recently begun doing so, specifically, for some cardiac imaging studies), those patients will be left in the cold. Services which are officially “covered” by Medicare, but which are reimbursed at such a low rate that they cannot actually be provided to them, will become unavailable even to Medicare patients who are willing and able to pay for those services.

DrRich’s main point, once again, is that our government has a deep and abiding need to limit our individual prerogatives when it comes to our healthcare, and has been acting on that need for a long time. The principle for these limitations on our individual liberties, the principle of social justice, has already been established, and has survived court challenges.

Extending these limitations on personal liberties to Obamacare, and broadening their usage, will not require any major changes in direction, or principles, or policy, but will merely require an expansion of already existent – and even “venerable” – rules, rules which have been an established part of Medicare for many years.

DrRich has expressed the idea that such restrictions by our government on such fundamental individual liberties are a very big deal indeed, and, in fact, signal an end to the Great American Experiment. His critics admonish him, however, that he makes too much of it, that, presumably, our government in its benign wisdom is just doing what’s best for us.

DrRich begs his readers to forgive him if he sees, in such a reply, even more evidence that the only nation in the history of mankind to be founded on the principles of individual freedom is well on the way to abandoning those exceptional principles, for the sake of the same, soothing-but-empty blandishments that have been offered, throughout human history, by well-meaning people who end up producing – or becoming – tyrants.

Podcast:

 

 Breaking the Doctor-Patient Relationship (Limiting Individual Prerogatives, Part 3) [20:54m]: Play Now | Play in Popup | Download (14)

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Part 1 of Limiting Individual Prerogatives

Part 2 of Limiting Individual Prerogatives

____________

The thing about Progressives is that the characteristic which makes them most endearing (and, which makes them most attractive to the unaware), is the very characteristic which makes them the most dangerous.

Fundamentally, Progressives believe in the perfectibility of mankind, or at least, of society. Indeed, they have discovered the very Program which will lead to the perfect society, a society which will maximize the good of the whole. Their vision is so compelling, and their ends so utterly and undeniably right, that it becomes legitimate for them to engage in whatever means are necessary to achieve it. (Indeed, for those who have been paying attention, “By Whatever Means Necessary” appears to have supplanted “Hope and Change” as the catchphrase of our current political leaders.)

The thing that always trips up Progressives (and their more revolutionary cousins, the Communists), is, of course, human nature. In order for their Program to work, it is necessary for each individual to behave in the prescribed fashion. And, at the end of the day, a substantial proportion of the population (any population) will insist on striving for their own individual benefit, rather than (as the Program requires) for the benefit of the collective.

The major competing system of societal organization – capitalism – recognizes this facet of human nature (i.e., the essential imperfectability of mankind, as manifested by the non-suppressibility of self-interest), and attempts to channel it into relatively productive and non-destructive (but still competitive and individually-directed) behaviors that limit the damage, and maximize the public good to a reasonable degree.

In contrast, Progressives attempt to change human nature to fit their inherently superior Program.

The fact that you cannot change human nature to fit the Program is what makes them dangerous. Their initial wide-eyed optimism that us folks will just “get it,” once they explain it to us, invariably evolves to an essential contempt for our limited intellectual capacity. This contempt justifies all manner of prevarications, to fool us into going along. Even in societies where the tyranny of correct-thinking has gone so far as to elicit the cooperation of the people at the point of a gun (rather than through the preferred methods of “education” or misdirection), the achievement of the predicted perfect society is invariably prevented by the recalcitrance of human nature. (The final realization that not even an all-powerful central authority can make people behave in the prescribed way always produces a nearly psychotic frustration that – in virtually every Communist country – has led to atrocities against various subsets of the recalcitrant people.)

DrRich does not believe there will ever be pogroms in the United States.

But this does not mean that the Progressives will always be kind and gentle as they attempt to achieve their goals. As DrRich sees it, in the U.S. the Progressives have clearly evolved to the “contempt for the masses” phase of their Program, a phase which justifies all manner of techniques – just this side of violence – to get us all to cooperate. Currently they are intent on demonizing their opponents as being racist, stupid, uneducated, selfish, overly dependent on outmoded supernatural beings, violent, and (of course) obese. This demonization is quite useful, since there is obviously no need to address any actual ideas put forth by such as these, even if they were capable of the feat of “ideas.”

Healthcare is, at present, the chief battleground in the war between Progressives vs. non-Progressives in the U.S., and the outcome of this battle will likely determine the success or failure of the entire Progressive Program. And the most fundamental (and emblematic) aspect of this battle is over what to do about the “doctor-patient relationship.”

The classic doctor-patient relationship was a celebration of the primacy of individual rights. And, for over 2000 years (at least since the advent of the Hippocratic Oath) guaranteeing the sanctity of that relationship was the basis of all medical ethics.

Until very recently doctors, patients, philosophers and ethicists recognized that, when you are sick, you are no more capable of navigating a complex and hostile healthcare system than are accused felons a complex and hostile legal system, and you are no less in peril if you run afoul of that system. And, just as the felon has a right to a personal advocate, a professional whose job is to protect his individual interests against the conflicting aims of the “system,” so does the patient. That is (quaint conventional wisdom held), when you are sick, you should be entitled to at least the same protections as when you rob a convenience store. And the doctor-patient relationship was supposed to guarantee you that right.

This is why, throughout the ages, the basic precepts of medical ethics were aimed at guaranteeing the sanctity of the doctor-patient relationship. Fundamentally, these ethical precepts required the physician to place the needs of his or her individual patient above all other considerations.

It should be clear to everyone that, under either our “old” healthcare system or the one that Obamacare promises us, this formulation of the doctor-patient relationship cannot be allowed to stand. Neither the insurance executives nor government officials can allow spending decisions – that is, decisions on how to spend their money – to be made by individual patients (and their personal advocates). For this reason, the classic doctor-patient relationship had to go.

And so, in 2002, official medical ethics was formally amended to require physicians (while still giving lip service to their obligation to individual patients) to strive for a “just distribution of healthcare resources.” That is, official medical ethics now makes it ethical for physicians to ration healthcare, covertly, at the bedside – and indeed, makes it unethical for them to fail to do so.

The New Ethics has been enthusiastically supported by medical ethicists worldwide (a field which now seems to be dominated by utilitarians), and worse, has been embraced by all the world’s major medical professional organizations. DrRich has not embraced the New Ethics (on the grounds that it places individual patients at great peril, and destroys the profession of medicine), and neither have many (possibly a majority) of older physicians. But it has been taught in medical schools around the world for over a decade, and in another decade it is likely that the vast majority of practicing physicians will accept as a matter of course that their primary obligation is to control healthcare costs, and only secondarily to try to meet the needs of their individual patients.

The plan, therefore, is for Obamacare to provide physicians with directives from expert panels on which medical services to supply to which patients and when, and for the New Ethics to allow physicians who go along with such directives to live with themselves. The feasibility of this plan depends entirely on physicians acceding to the program.

So, incentives are being put in place to “help” doctors cooperate. Quality measures will be implemented, with “quality” being defined as doctors doing what they’re told, and reimbursement will be tied to one’s quality rating. Possibly more persuasive will be the fact that the Feds can construe the failure to follow handed-down rules, regulations and guidelines, at any time, as a federal crime. (Even doctors who don’t mind being labeled as “substandard quality” – perhaps even considering the label as a badge of honor – will mind going to jail.)

But by whatever means necessary, the happiness of the government is to be the doctor’s first consideration, and not the happiness of their individual patients. The classic doctor-patient relationship is being terminated with extreme prejudice.

To see just how important it is to destroy the doctor-patient relationship, one merely has to observe what is happening to primary care doctors who have the audacity to leave the system, and set up a direct-pay medical practice.

Part of the problem, to be sure, was caused by these doctors themselves. The first few to do so unabashedly catered to rich patients, and to attract the rich, referred to themselves as “concierge” practitioners. This name (and its elitist connotations) have been forcibly affixed to all direct-pay practitioners, even as this style of practice has evolved into a much more democratic form. Today, more and more doctors are starting direct-pay practices (in which patients pay the doctors out of their own pockets) which are easily affordable to anyone who can afford a cell phone or cable TV contract.

While many direct-pay practices offer patients certain benefits they can usually not get from primary care doctors who remain in the approved system (such as phone and e-mail access, same-day appointments, appointments lasting as long as necessary instead of the allotted 7.5 minutes, etc.), the fundamental benefit, to both the patient and the doctor, is that it restores the classic doctor-patient relationship. The physician’s primary obligation is no longer to the 3rd-party overlord, or to the Progressive ideal of social justice, but to the patient.

And while critics (who abound) attack direct-pay practitioners for their elitism, laziness, and greed, their real issue is that direct-pay practitioners are acting as if their primary duty is to their individual patients, and not to the needs of society. This latter fault simply cannot be tolerated.

Having gained nearly complete control over the behavior of primary care practitioners, it is critical for Progressives – in making sure that practice by handed-down “guidelines” is not simply the only legal way to practice, but also the only ethical way to practice – to shut the door to any alternative forms of primary care. Direct-pay practitioners are a menace because they threaten to raise the expectations of both doctors and patients. Perhaps, doctors and patients might tell themselves, there really is a way to maintain individual autonomy within the healthcare system.

The attacks on direct-pay practitioners have followed the usual scheme Progressives follow when they discover a faction they need to suppress. First, they were ridiculed. “For a Retainer, Lavish Care by ‘Boutique Doctors,’” said a headline in the New York Times in 2005. Then, they were demonized, widely attacked for their elitism, laziness, greed, and lack of fundamental medical ethics. In this latter effort, it was not difficult to find fellow physicians – generally, from the medical organizations which promulgated the New Ethics – to lead the attacks. There are countless examples. DrRich will give just two.

Anthony DeMaria, then President of the American College of Cardiology, criticized the practice of direct-pay medicine in an article in the JACC in 2005, saying, “Personally, I do not mind if people acquire yachts or personal trainers if they have enough money, nor would I object if they secured a physician at their beck and call. However, unlike yachts, health care is not discretionary, and everyone should be entitled to the same quality.” As a matter of social justice, direct-pay physicians improve healthcare quality for only some patients, and so have no place in the healthcare system.

In an article in the New England Journal of Medicine, Troyen A. Brennan (M.D., J.D., and M.P.H., so we know we’re in trouble) really gets to the point. Referring to direct-pay practices as “luxury primary care,” he notes that “traditional medical ethics is rather poorly equipped to address issues related to luxury primary care.” That is, while “traditional” medical ethics always places the individual patient first, that kind of thinking is now outmoded. “(M)ost ethicists now agree that the financial structure of health care is an important subject for ethical consideration. Access to health care, in particular, is a salient ethical issue.” Direct-pay practitioners threaten (by their elitism and the limited size of their practices), to limit access to primary care, and thus are in fundamental violation of medical ethics.

The argument here, for those who missed it (advanced by fellow physicians no less), is that, of the two competing ethical precepts now established by New Medical Ethics (i.e., the physician’s obligation to the individual patient vs. the physician’s obligation to society), clear primacy is to be given to the physician’s obligation to society. Physicians must (like it or not) participate in covert bedside healthcare rationing. Physicians who take the only path remaining to them that allows them to make the individual patient their primary obligation are to be castigated as ethically deficient.

When ridicule and demonization fail to suppress their opposition, Progressive dogma indicates it’s time to resort to force. The first pass in this regard, of course, is always to render the opposition illegal. (Actual violence is reserved for criminals who persist in their misbehavior, despite more polite efforts to get them to behave lawfully.)

Making direct-pay medical practice illegal has not been accomplished yet, but clear efforts have been made in this regard. Noting with alarm the rise of direct-pay primary care, numerous Congresspersons have issued statements of concern, suggesting that perhaps Congress should look into the propriety of such activities.

Indeed, the first step by Congress has already been taken. In 2003, as part of the Medicare Prescription Drug, Improvement, and Modernization Act, Congress directed the GAO to study and report on the effect of direct-pay practices on Medicare patients. The GAO did so in 2005, and a fair paraphrase of its report is as follows: “The practice of direct-pay medicine is not currently a threat to Medicare patients, because the direct-pay movement is not large enough yet to have an impact. If it does begin to have an impact on Medicare patients, action will have to be taken.” That is, direct-pay medicine was considered OK in 2005 not because it was inherently an ethical and legal form of medical practice, but simply because there were not enough practitioners at that time to significantly affect Medicare patients. The clear implication is that Congress stands ready to pass laws outlawing – or, at least, severely limiting – direct-pay practices, as soon as those practices begin to “impact” the system.

Certain state governments are not waiting for Congress to ban direct-pay practices. The state of Maryland (and a few others) have taken the creative position that, because many direct-pay practices work on a retainer basis, they meet the definition of a health insurance company. And as a health insurance company, to be considered legal entities, they have to have millions of dollars set aside to pay for unforeseen “claims.” (Interestingly, this same argument was not applied to Maryland lawyers, who also often work on a retainer model.) According to the Baltimore Sun, the state’s stance in this regard has already successfully caused several primary care physicians to abandon their plans to become retainer practitioners.

Less devious (but more draconian) than the state of Maryland is the state of Massachusetts (whose universal healthcare system, we’ve all heard, is a preview of Obamacare circa 2015). A bill is under consideration in the Massachusetts Senate (Bill 2170) which requires doctors, as a condition of their licensure, to accept payment rates as determined by the government. If it passes, it will be the first actual legislation in the U.S. to ban direct-pay medicine, if only by making it completely impracticable. (Thanks to Dr. Wes for pointing out this important development.)

Since medical licensing is controlled by the various states, of course, it would take 50 bills like the one in Massachusetts to really get rid of direct-pay healthcare. But there are other ways for the Feds to accomplish the same thing. Now that the federal government directly controls all student loans, for instance, it would be a simple matter to make those loans contingent on agreeing to become primary care doctors working strictly within the government controlled system, or to offer loan forgiveness for doctors who agree to do so, or to rescind favorable re-payment conditions (retroactively, and decades after the fact, if necessary) for doctors who go to a direct-pay model later in life.

DrRich does not really know how the Progressives will actually place the final nail in the coffin of the doctor-patient relationship. All he knows is that they have – well, more than the desire – the deep and abiding need to kill that relationship, once and for all. Unless we the people decide we ought to stop them, this is going to happen.

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Part 4 of Limiting Individual Prerogatives

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 The Real Fight is Just Beginning (Limiting Individual Prerogatives, Part 1) [12:52m]: Play Now | Play in Popup | Download (5)

Unlike many of those who actually supported President Obama’s healthcare reform, DrRich always remained confident (even during the darkest days, such as right after the Scott Brown election) that Obamacare would pass.

DrRich’s confidence stemmed from the simple fact that the health insurance industry required this outcome. That industry, having clearly reached the end of its life-cycle and having nowhere else to turn, desperately needed the government to provide it with a graceful exit strategy. And Obamacare, which promised to convert the health insurance industry into a public utility, was as good a deal as they were going to get. And so, while the President and his supporters traveled the land, painting insurers as the very embodiment of all healthcare evil, with sundry hapless victims of insurance industry atrocities in tow (for demonstration purposes), we Americans were treated to the spectacle of the insurers themselves not only declining to defend themselves, but actively adding fuel to the fire whenever necessary to keep reform moving along, and gratefully embracing their assigned role as the villains of the set piece. And in the end we got the healthcare reform the insurers desperately needed.

So, dear readers, now that this thing has finally come to pass, it is time to prepare ourselves for the real fight, the fight whose outcome is actually in question, and which will determine not merely what kind of healthcare system we will finally end up with, but more importantly, what kind of society we will be. That question, of course, is whether individual Americans ultimately will be restrained from using their own resources to provide for their own medical care.

DrRich has said many times that this was to be our real battle. And whenever he has said this, loyal (but misguided) readers have questioned his sanity – or at least, his judgment. There is simply no reason (these critics insist) for our leaders to attempt to prevent individuals from buying some of their own healthcare with their own money. There is nothing in the bill (they go on) that explicitly does so. And besides (they offer as a clincher), we’re Americans, and even our clueless political leaders know that we’d never stand for it. The very notion that our government would try such a thing amounts to simple paranoia.

DrRich sincerely hopes his critics are right, and that his fear over such a restriction to our personal liberties is just one more manifestation of his paranoid psychosis. For, if his critics are right, not only do we have drugs for that, but also DrRich would be allowed to buy them.

DrRich is sorry to say, however, that if we Americans are to suffer no restrictions on our ability to purchase healthcare services with our own money (and, ultimately, on our ability to expend any individual resources for any individual benefit), this outcome will likely result solely from enough of us remaining vigilant, and vigorously fighting oppressive efforts whenever we find them. It will not result from our complacency, or from placing our trust in the beneficence, the common sense, or the respect for fundamental American precepts, of our political leaders.

This will truly be a momentous fight. Its outcome will determine, to a very great extent, what kind of country we will be, and more importantly, whether the Great American Experiment – arguably the greatest secular endeavor in human history – will continue, or will end in a whimper.

In this and in the next few posts, DrRich will attempt to explain himself by addressing three specific questions. 1) Why must individual prerogatives be restrained in our new healthcare system? 2) What evidence do we have that such restraining efforts are already in the works? 3) How have such restraining efforts already become ingrained in our current, pre-reform healthcare system?

Why Individual Prerogatives Must Be Restrained

It is natural and unavoidable for universal healthcare systems to strive to limit individual prerogatives.*

These healthcare systems are “universal” in two senses. First, they attempt to cover all people. Second, almost by definition they cover “all” healthcare services. Under America’s new healthcare law, for instance, our new health insurance utilities (formerly health insurance companies) are required to issue policies (which every American must have) that cover everything. “Qualified” health plans under our new law MUST cover (as laid out in Section 1302): ambulatory patient services, emergency services, hospitalization, maternity and newborn care, mental health and substance use disorder services, including behavioral health treatment, prescription drugs, rehabilitative and habilitative services and devices, laboratory services, preventive and wellness services and chronic disease management, pediatric services, including oral and vision care.

Fundamentally, this “universality of features” reflects a particular philosophy. The central authority is telling the individual that “everything” will be taken care of for them, from soup to nuts. So no need to worry your pretty little heads. But, as always when the central authority assumes all responsibility for providing some aspect of security (in this case, healthcare security), it also assumes all control.

It is important for the government to control all healthcare spending not only because it is the natural state of governments to continually accrue all the power they can (see: Thomas Jefferson), but also because, in the case of healthcare, controlling all expenditures is essential for the purpose of covert rationing.

Allowing individuals to spend their own money fundamentally undermines such a system. It implies that the central authority is actually not supplying all useful healthcare services (when, by definition, it is), and thus implies that the government may be doing some kind of rationing. When one is dedicated to rationing covertly, such an implication cannot be permitted.

Perhaps more importantly, when individuals are allowed to purchase “extra” healthcare, that’s a graphic admission to the unwashed masses that there is extra healthcare to be had. That is, it raises expectations for everybody, and these higher expectations make it that much more difficult for the central authority to pull its covert rationing strings.

(The official reason the central authority will always give for restricting individual prerogatives is one of “fairness.” Allowing the rich to go outside the system would create an unfair, two-tiered healthcare system, etc., etc. But the real reason is that individual healthcare spending undermines the government’s control, and that control is essential for covert rationing.)

The critical importance of controlling the expectations of the masses is nicely illustrated by some of the problems being experienced by the British and the Canadian healthcare systems. In both of these systems, the very visible progress that has been made in the American healthcare system – new drugs, new techniques and new technology – has created new demands and new expectations among Canadian and British citizens. Essentially, seeing what was possible, enough of the population demanded better care that something had to change.

The inability of these universal healthcare systems to ignore such increased expectations has led to an acceleration in expenditures, and even to loosening up the restrictions on individuals. (Both of these universal systems started out, as a simple matter of course, by strictly forbidding individuals from purchasing “extra” healthcare with their own funds.)

Some of DrRich’s critics have argued that such “loosening up” shows that any restrictions on individuals simply will not stand – so we don’t really have anything to worry about. For, if such restrictions cannot be maintained in Canada or Great Britain, how will they ever be maintained in the U.S.? Perhaps. But DrRich suggests that, to the contrary, the fact that restrictions on individuals in Canada and Great Britain systems had to be revised simply illustrates the critical necessity, in any universal healthcare system, of managing expectations. For a failure to manage expectations, obviously, leads to a loss of control. Had it not been for the very visible example of American healthcare to show them what was possible, citizens of Canada and Great Britain quite possibly never would have agitated for “more.” As it is, thanks to the unfortunate example of high-cost healthcare their citizens saw in the U.S., British and Canadian officials were simply unable to manage the expectations of their citizenry.

Now that we too will soon have mandated universal healthcare (much to the relief, no doubt, of Canadian and British healthcare bureaucrats), it will become critically important for our government to manage the expectations of American citizens. Since American healthcare bureaucrats won’t have an annoying external healthcare system to worry about, continually displaying more effective, and more expensive, healthcare options,the job will be somewhat easier for them than it was for their counterparts in Canada and England. For American bureaucrats, managing public expectations will mainly mean restraining individual American citizens from going outside the system, and buying extra healthcare with their own money. This makes restricting individual prerogatives in the U.S. critical, even more critical than it was in our cousin nations. And we should not be surprised if our bureaucrats employ some very devious and even draconian maneuvers to do so.

DrRich believes that they will pull out all the stops to restrict individuals. Whatever methods they employ will, of course, be conducted only for the best of reasons – to have the fairest healthcare system possible, to have the most ethical healthcare system we can devise, and to protect misled Americans from throwing their hard-earned money away on unproven medical services. Whatever the reasons they might offer, their attempt to restrict individual prerogatives will become deadly serious, because doing so is absolutely essential to their real aims.

Covert rationing demands it.

*This is the case in practice, but not necessarily in theory. In his book, DrRich proposed a kind of universal healthcare system in which each American would be provided with catastrophic universal health insurance (which would operate under a system of open and transparent rationing), and in which Americans would then be expected to buy their more routine healthcare, as well as any non-covered healthcare they might want, themselves. (Poor Americans would be subsidized to do so.) But a system like DrRich’s encourages – even demands – individual responsibility, and is therefore philosophically objectionable.

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Part 2 of Limiting Individual Prerogatives

Part 3 of Limiting Individual Prerogatives

Part 4 of Limiting Individual Prerogatives