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Note: DrRich has issued this warning more than once before. It has always gone unheeded. He will now try one more time, with this updated and hopefully more compelling version, not because he actually believes it will do any more good than similar warnings did those other times, but because he is a humanitarian and time is growing short. American physicians will continue to ignore this warning at their own peril.

The history of Western civilization, from prehistoric times until relatively recently (so recently, in fact, that one cannot be absolutely certain the pattern has been broken), has been marked by successive waves of invasions by wild barbarians from the north. (This explains why DrRich will never completely trust the Canadians.)

Every few hundred years, one group of primitives or another – Scythians, Goths, Vandals, Huns, Avars, Norsemen, Bulgars, Mongols, and others named and unnamed – would sweep down upon their betters, upon the more civilized, more culturally and intellectually advanced people to the south, and by the expediencies of slaughter, rape and pillage, would take their land, possessions, freedom, and their lives. The advancing barbarian wave would eventually play itself out, and individual members of the untamed horde would simply settle in place, and over a few generations would become civilized themselves – until the next group of barbarians, in turn, would fall upon them.

It was a cycle as natural as the seasons.

What drove these irresistible barbarian movements? Historians still argue about it. Likely these violent migrations were caused by several different things – famine, plague, encroachment by even nastier barbarians from even farther north, and climate change (though this latter conjecture is now politically incorrect, since the official and proper view of the earth’s climate is that it was absolutely stable for millions of years, until Henry Ford and George Bush came along and bent the temperature curve upwards, like a hockey stick).

The reason DrRich brings all this up, of course, is: to warn his medical colleagues about the cardiologists.

Dear reader, the cardiologists are on the move. Their home turf is being encroached upon, their livelihoods gravely threatened, by the biggest, most ruthless, and most irresistible force on earth – the Feds. And in response they are gathering themselves into a great wave, and they are preparing to overrun the territories of less robust, less terrifying, more civilized (possibly more effete) medical specialists, and make themselves a new home.

Some medical specialists aside from the cardiologists are of course also predatory by nature, but for the most part their territorial incursions are predictable, localized and contained – the orthopedic surgeons and the neurosurgeons, for instance, will fight over lumbar disc surgery. Not so for the cardiologists.

DrRich is a cardiologist, and he knows that the Board Certification papers wielded by cardiologists do not read: “Certified in the practice of cardiac medicine,” but rather, “Certified in the practice of cardiovascular medicine.” Cardiologists, in other words, are officially certified not merely in the practice of heart disease, but also in the practice of any and all disorders affecting the blood vessels.

And DrRich urges his unsuspecting medical colleagues to please notice that blood vessels are prominent features of every organ system in the body. Cardiologists therefore recognize no natural limits to their rightful turf; if it is supplied by the vascular system, it is theirs. And if some other kind of specialist has traditionally claimed sovereignty over some particular organ – say, the liver – their continued success lies entirely in the fact that the cardiologists have not yet chosen to assert their rightful authority. (As it happens, hepatologists are relatively safe, as most cardiologists think of the liver as a particularly uninteresting organ, which, after all, just sits there doing nothing. Many cardiologists, in fact, persist in getting the liver and the kidneys mixed up.) Still, should it ever become convenient for cardiologists to invade the hepatologists’ space, these relatively intellectual, relatively sedentary specialists don’t stand a chance.

What all this means is that when the cardiologists are on the move, nobody is safe. And they are on the move.

Hide the women and children!

The cardiology settlements have been restless for years, continually expanding and growing, and spilling out across their borders to encroach on the turf of their nearby neighbors. They long ago began driving the formerly proud and powerful cardiothoracic surgeons into a sad state of underemployment. More recently they have usurped the formerly sovereign territory of diabetes specialists. They are currently laying siege to sleep medicine (pulmonary specialists) and bariatrics (weight loss specialists). All of these incursions can be related, within one or two degrees of freedom, to heart disease. So these are localized disputes.

But in the last year or so, cardiologists have moved from a state of mere restlessness to a state of high alarm. The ruthless Feds (a mysterious tribe arising from a dark, inexplicable cauldron of a place where even the laws of physics, economics, and human nature do not apply) have taken to attacking the cardiologists where they live – in their home turf of stents and implantable defibrillators. By conducting secret and extensive DOJ investigations as to whether cardiologists are plying their trade according to “guidelines” (a form of tribute acknowledging their state of thrall to the Central Authority), and by threatening to jail them or fine them into professional oblivion (to the point where even the ubiquitous threat of malpractice suits has become a relatively trivial concern), the Feds have forced cardiologists to recognize that it is time for them to move on. It is time to seek out new territory.

There is no telling where they will show up next. If any of you non-cardiologists think you are safe, think again.

To illustrate just how unpredictable the Great Cardiology Migration is likely to become, DrRich will review a few of their recent incursions into the territory of some of the least likely of the medical specialists – the neurologists and the neurosurgeons.

The cardiologists’ encroachment into the field of neurological medicine is not only surprising in itself (for who would have thought that such shoot-from-the-hip, action-addicted specialists would find anything interesting about the brain?), but especially surprising is its scope and its persistence. Cardiologists actually began this process several years ago, under the radar, when they took to blaming imbalances of the autonomic nervous system (i.e., dysautonomia) on mitral valve prolapse. In more recent years, and somewhat more openly, they have attempted to take ownership of migraine headaches.

And now, in recent months, cardiologists have laid claim to the brass ring of the neurological diseases – Alzheimer’s Disease. If they can wrest this common and expensive disorder away from the neurologists, a disorder which people will pay almost any amount of money to prevent or treat, they can set themselves up for generations.

The typical pattern of behavior employed by the cardiology invaders is easy enough to spot. First, they call attention to an alleged association between some cardiac condition (a condition they will manufacture if necessary), and a neurological disorder. Then, immediately, they will assert that (or at least begin behaving as if) the association proves a cause-and-effect relationship. Finally, since they have demonstrated that the neuro problem is produced by a cardiac condition, it will become necessary to refer patients who have (or might develop) that dreaded neuro problem to cardiologists, who, lo and behold, will have invented a well-paying procedure which they claim will treat it.

The best known example is mitral valve prolapse (MVP), a congenital condition in which the mitral valve partially flops open when it should be closed, thus allowing blood to flow backwards (i.e., to regurgitate) across the mitral valve as the heart contracts. (For anyone interested, here’s a brief description of the heart’s chambers and valves.) Now, significant MVP can be a serious medical problem which requires mitral valve surgery. Fortunately, however, this kind of serious MVP is relatively uncommon.

But happily for cardiologists, echocardiography (a non-invasive test using sound waves to create an image of the beating heart) has become so advanced that some degree of trivial MVP, it seems, can be found in almost anybody. According to some studies, as many as 25 – 35% of healthy individuals – people without any cardiac problems or any symptoms whatsoever – can be said to have some degree of MVP. In fact, whether you have MVP or not depends largely on what criteria the echocardiographer uses to make the call, and how badly the referring doctor wants you to have the diagnosis.

Over the years it has become customary to diagnose MVP in young, apparently normal people who have the temerity to complain about the highly disruptive symptoms of dysautonomia (such as fatigue, weakness, strange pains, dizziness, constipation, diarrhea, cramps or passing out), without supplying the kinds of objective physical or laboratory findings which, doctors insist, patients are always obligated to provide. Such thoughtless patients are now routinely sent for echocardiography, so that MVP can be diagnosed (since it can be diagnosed just about whenever it is looked for). The patient is then given the diagnosis of “mitral prolapse syndrome,” even though: a) the MVP is usually so trivial as to be nonexistent; b) the studies which claim to show an association between MVP and these sorts of symptoms are generally based on a gross over-diagnosis of MVP; and c) there is no credible theory based on actual physiology to explain how MVP – even real MVP, much less the trivial kind – might cause such symptoms.

But no matter. “Rule out MVP” has become one of the most common reasons for young, healthy people to be referred for echocardiography, and has become a stable source of income for cardiologists.

The story is similar for the association between patent foramen ovale (PFO) and migraine headaches.

In the developing fetus, the foramen ovale is a hole that is present in the atrial septum (the thin structure that separates the right atrium from the left atrium). At birth, a flap of tissue imposes itself over the foramen ovale, causing it to close. In some people, however – people with PFO – the tissue flap is still capable of flopping open. In people with PFO, the foramen ovale can open for a few moments if the pressure in the right atrium becomes transiently greater than the pressure in the left atrium, such as with coughing, or straining during a bowel movement.

In rare instances, strokes in healthy young patients have been attributed to PFO. The supporting theory is that a stroke can occur when a blood clot happens to be coursing through the right atrium at the precise moment when a person with PFO is coughing (for instance), allowing the clot to move into the left atrium, and on to the brain. And because this theory is at least plausible, in a young person who has an unexplained stroke and is then found to have a PFO, it makes at least some sense to close the PFO.

But the presence or absence of a PFO is a little like the presence or absence of MVP. Its diagnosis depends to some extent on how hard the echocardiographer looks for it, and on how much the referring doctor would appreciate the diagnosis. With modern echocardiographic equipment, at least some sign of PFO can be found in as many as 25% of normal individuals.

Being able to make this nifty diagnosis would be of little use to cardiologists if the only clinical problem it may cause is a one-in-a-million chance of stroke. One cannot make a living, or even make a decent car payment, doing echocardiograms in those extremely rare young patients with cryptic strokes. So it didn’t take long for cardiologists to draw a more useful association – this time, between PFOs and migraine headaches.

While all the things that have to happen in order for a PFO to cause a stroke are very unlikely, at least one can assemble a string of very unlikely events that, should they all occur simultaneously, might possibly produce a stroke. This is not the case with migraine. No plausible theory has been advanced to explain how PFO might cause migraines. The only reason PFO is being invoked as a cause for migraine is that when patients with migraine have been carefully studied for the presence of PFO, an increased incidence of PFO was found. (But again, when PFO is carefully sought in any population of patients, it is more likely to be found.) The only likely reason PFO has not been associated with cancer, red hair, type A personality, or difficulty in memorizing the multiplication tables is that cardiologists have not thought of looking for it (yet) in these conditions.

For cardiologists, the poorly-supported allegation that PFO causes migraine is particularly compelling, since not only can they get paid for the echocardiograms to look for PFOs in migraine sufferers, but also there is an invasive (and lucrative) procedure they can do to close PFOs, to “treat” the migraines. Studies to date have not been successful in showing that closing PFOs improves migraine headaches, but that hasn’t kept cardiologists from screening migraine patients for PFO, then offering them PFO closure as a therapeutic option.

Migraine sufferers are particularly vulnerable to this and many other unproven therapies, since they are often disabled by their condition, and in many cases medical science (or medical ignorance) offers them insufficient help. Consequently, anecdotal stories abound regarding unorthodox therapies that cure migraines. (DrRich, himself a migraine sufferer for many decades, has heard them all.) One undeniable truth is that merely performing PFO closures on enough migraine suffers is guaranteed to produce a patient here or there who will report a positive response. And despite the continued negativity of actual clinical trials so far, that’s what happened.

So, by anecdote – but not by controlled trial – closing PFOs can cure migraines.

But now it gets even worse for the neurologists. Any who ignored the cardiologist’s usurpation of dysautonomia, and who may have felt only a little more concern when cardiologists began to lay claim to migraine headaches, had best sit up and take notice. Because now, cardiologists are laying claim to Alzheimer’s Disease.

Recently, researchers presented a study suggesting that ablation procedures for atrial fibrillation are associated with a lower risk of subsequent Alzheimer’s disease. (Here’s some information on atrial fibrillation and its treatment if you are interested.) The study was presented as an abstract only, so we know relatively little about the specifics.

But, really. Atrial fibrillation and Alzheimer’s are both disorders associated with aging, so it is not surprising that they are associated with each other – in the same way that atrial fibrillation is associated with gray hair, cataracts, and bunions. Ablation for atrial fibrillation is a relatively lengthy and difficult procedure, whose results are relatively middling, and which carries a substantial risk of some really nasty complications. So these ablation procedures are generally reserved for carefully selected, reasonably ideal candidates – usually, the relatively young, relatively healthy atrial fibrillation patients, who are less likely to get Alzheimer’s disease over the next few years whether they have ablations or not.

So there is a lot to be cautious about in interpreting a preliminary study like this one.

But such objections are just quibbles. When this study was reported, the headlines in the typically discerning American press blared: “Ablation Procedures For Atrial Fibrillation Prevents Alzheimer’s.” Whatever the details and limitations of this study, cardiologists can now treat Alzheimer’s. Mission accomplished.

Then, just last week, the American Heart Association and the American Stroke Association released a formal scientific statement to the effect that vascular disorders are an important cause of Alzheimer’s disease. So this new statement clearly plants the flag for the AHA’s chief constituency – the cardiologists (who, DrRich reminds his readers, own vascular disorders).

Remarkably, the American Academy of Neurology, apparently failing utterly to grasp its significance, endorsed the statement. As a result, American neurologists have formally taken the knee before their new masters.

You see how this works?

Now, having for the last time, with an unerring sense of fair play, called this problem to the attention of his non-cardiologist medical colleagues, DrRich would like to finish by emphasizing an overarching point.

You can’t fight the Feds. When the Central Authority, at the point of a gun, decides to reach down into the world of the medical specialists, and dictate which medical services are no longer going to be feasible (all for the noblest of purposes, of course), the affected medical specialists have a limited range of possible responses. And fighting the Feds is NOT among these available responses. It would be more effective – and certainly safer – for doctors to fight against the change of the seasons.

So the affected specialists have only two options. They can contract their horizons, take what’s left, and try to make the best of it. Or, they can do what the Visigoths did when the people of the steppes fell upon them. Strike out against other, weaker tribes and take what’s theirs.

DrRich is not passing any judgment on his cardiology brethren here. (Would you have him judge a she-bear protecting her cubs?) He is just describing what’s happening. You who lie in their path can do with the information as you see fit.

In the meantime, DrRich remains supremely confident that his cardiology colleagues can find a nearly unlimited supply of plunder in this brave new world. They are very robust barbarians.

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In an earlier post, DrRich offered several potential strategies for doctors and patients to consider should healthcare reformers ultimately succeed in their efforts to make it illegal for Americans to seek medical care outside the auspices of Obamacare. To those readers who persist in thinking that DrRich is particularly paranoid in worrying about such a thing, he refers you to his prior work carefully documenting the efforts the Central Authority has already made in limiting the prerogatives of individual Americans within the healthcare system, and reminds you that in any society where social justice is the overriding concern, individual prerogatives such as these must be criminalized. Indeed, whether individuals will retain the right to spend their own money on their own healthcare is ultimately the real battle. The outcome of this battle will determine much more than merely what kind of healthcare system we will end up with.

DrRich, despite his paranoia on the matter, is a long-term optimist, and believes that the American spirit will ultimately prevail. So, to advance this happy result DrRich (in the previously mentioned post) graciously offered several creative options that could be employed to establish a useful Black Market in healthcare, which will allow individuals to exercise their healthcare-autonomy against the day when such autonomy again becomes legal. His suggestions included offshore, state-of-the-art medical centers on old aircraft carriers; combination Casino/Hospitals on the sovereign soil of Native American reservations; and cutting-edge medical centers just south of the border (which would have the the added benefit of encouraging our government to finally close the borders to illegal crossings once and for all).

As entertaining as it might be to imagine such solutions, a readily available, though much more mundane, option exists today, which is to say, medical tourism.

Medical tourism is where one travels outside one’s own country in order to obtain medical care elsewhere. It is becoming a booming business. A number of superb state-of-the-art medical centers expressly aimed at attracting medical tourists have been established in the Middle East, Singapore, India, China and elsewhere in Asia. These institutions cater to citizens of the world whose own healthcare systems cannot (or will not) provide in a timely fashion (or at all) the level of care patients may desire. Many of these institutions offer modern hospitals, numerous amenities, luxurious accommodations, attentive nursing care, and top-notch doctors – and they do it all for a tiny fraction of what the same care might cost (if you can even find it) in the U.S. and other “first world” nations.

Obviously, medical tourism is not particularly feasible for medical emergencies such as heart attack or stroke, or for chronic illnesses such as diabetes, congestive heart failure, or Parkinson’s disease, which require frequent visits and long-term management.  What is feasible is to become a medical tourist for those one-time medical services that can be scheduled and planned, for which there is a long waiting period at home, or which is simply too expensive in one’s own country. Such medical services often include coronary artery bypass surgery, hip replacements, knee replacements, and numerous minimally-invasive and not-so-minimally-invasive surgical procedures. In other words, medical tourism to a large extent is something one does for elective (i.e., non-emergency) surgery.

These are the very procedures, as DrRich has pointed out, which are now being covertly rationed in the U.S. thanks to the “never events” policy adopted by CMS and private insurers. As a result, certain categories of individuals may soon find it more difficult to obtain elective surgical services than they might have just a few years ago, and medical tourism may accordingly become a more compelling alternative.

It ought not be a surprise, therefore, that the first organization of American physicians to issue a formal policy statement regarding medical tourism is the American College of Surgeons.

The reaction of American surgeons to medical tourism ought to be obvious. They hate it. Elective surgical procedures – the very procedures for which Americans become tourists – are the bread and butter of most surgical specialties. It pains them to think of their prospective patients going off to Singapore for their lucrative bypass surgeries. American cardiac surgeons, for instance (already underemployed, thanks to American cardiologists throwing stents at every tiny coronary artery indentation they they can justify as a “blockage”), are nearly apoplectic at the idea.

It’s always a delight to read formal policy statements which attempt to disguise an entirely self-serving message as a selfless public gesture. The actual message of the surgeon’s policy statement, of course, is, “We hate medical tourism, and if you do it we’ll hate you,” but they say so on a manner which is designed to be polite, politically correct, non-judgmental, helpful and even friendly.

The surgeons in general have made a good effort, as you can see if you’d like to read the policy statement for yourself. It’s pretty much what you would expect – “Go ahead and have your knee replaced in Timbuktu if you want to. It’s your right, so go ahead and devil take the hindmost. Just don’t come crying to me when things go south a month later.”  They do so, however, in an extraordinarily collegial way.

The artful style of their policy statement aside, DrRich is struck by two aspects of the actual substance of the document.

First, the surgeons begin with a litany of dire warnings regarding all the medical considerations one must take into account before trusting one’s health to foreign medical hands:

“Some of the intangible risks include variability in the training of medical and allied health professionals; differences in the standards to which medical institutions are held; potential difficulties associated with treatment far from family and friends; differences in transparency surrounding patient discussions; the approach to interpretation of test results; the accuracy and completeness of medical records; the lack of support networks, should longer-term care be needed; the lack of opportunity for follow-up care by treating physicians and surgeons; and the exposure to endemic diseases prevalent in certain countries. Language and cultural barriers may impair communication with physicians and other caregivers.”

Obviously, these are all very important considerations. What strikes DrRich, however, is that these are the very same considerations (even the warning about endemic diseases, when one considers the MRSA infections which are secretly “endemic” in some American hospitals) which patients must also take into account before agreeing to receive care in any American institution. It may turn out that these considerations are more an issue in top-notch foreign hospitals than in your average American hospital, but DrRich is not convinced this is the case, and the surgeons do not provide any evidence that it is. In other words, DrRich sees this very good advice as being equally applicable whether one is considering becoming a medical tourist, or just a typical American patient.

Second, and more astonishingly, DrRich notes – not so much with interest, but more with awe – that the surgeons are beseeching their patients to consider just how difficult it might be to launch a malpractice suit against foreign doctors. (DrRich himself does not know how difficult this would be. Given that we are being so strongly urged these days to merge the American legal system with several varieties of international law, it might not be such a big problem.) Indeed, a careful reading of this policy statement reveals that the potential difficulty in suing foreign doctors is offered as the chief differentiator, and thus it has become the primary argument in favor of good-old-American-surgery. The surgeons, in essence, are saying, “Let us do your surgery, because we’re easier to sue if we screw up.”

This, from the very body of American physicians who are most at risk for malpractice suits, and who traditionally have been most vociferous in favor of malpractice reform.

DrRich can only shake his head in wonderment. If medical tourism is viewed by surgeons as such a dire threat that they have embraced, as their chief weapon against it, a celebration of the ease of suing American doctors, why, one can only conclude that medical tourism must have caught on far more than most of us realize.

As an American physician who has always been proud of American medicine, DrRich’s innate tendency is to lament the fact that Americans are finding it to their advantage to travel to Mumbai for their hip replacements. But as a patriot, he celebrates the fact that his fellow citizens are willing to go to such lengths to exercise their individual autonomy. He finds it a hopeful sign.

Our would-be oppressors might find it more difficult to hold us down than they may think.

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In 2008, the Centers for Medicare and Medicaid Services (CMS) announced it would no longer pay for the treatment of “never events,” i.e., certain medical conditions in hospitalized patients which the Feds deem to be universally avoidable under all circumstances. These conditions included:

* Decubitus ulcers
* Two kinds of catheter-associated infections
* Air embolism
* Mediastinitis after coronary bypass surgery
* Transfusing patients with the wrong blood type
* Leaving objects inside surgery patients
* In-hospital falls

Then, having been delighted with the results of its original list (or dismayed that healthcare costs continued to skyrocket despite its original list) CMS subsequently proposed declaring several new conditions as “never events,” including:

* Surgical site infections following certain elective procedures
* Legionnaires’ disease
* Extreme blood sugar derangement
* A collapse of the lung resulting from medical treatment
* Delirium
* Ventilator-associated pneumonia
* Deep vein thrombosis or pulmonary embolism
* Staph infection in the bloodstream
* Disease associated with Clostridium difficile infection

Numerous commentators have expounded on the advisability of declaring these particular conditions to be “never events.” All agree that while certain of them clearly should never be permitted to happen (e.g., leaving sundry tools inside a patient’s abdomen, or transfusing the wrong blood), certain other ones are going to continue happening to some patients no matter how high the quality of the institution and the medical professionals.

Because this topic has been so well-covered in the medical blogosphere, DrRich does not need to comment any further on the unfairness of insisting that doctors prevent every single instance of conditions that are often not particularly preventable; or on the fact that insurance companies quickly followed Medicare’s lead and now also refuse to pay for these “never events;” or that hungry attorneys have voraciously begun suing doctors and hospitals for unavoidable complications because those complications have been federally designated as avoidable; or even the fact that, having so deftly expanded the horizons of what can be considered a “never event,” the feds have cleared the path for defining virtually any medical condition they choose as a “never event.”

(As a case in point, DrRich notes that the feds’ own guidelines on preventing delirium, referred to in their own “fact sheet” that purports to justify the expanded list of “never events” admits that there are no effective means of reliably preventing delirium.)

There’s also no point in physicians complaining publicly about this expanded list of “never events,” since the public is foursquare behind the notion that no medical complications should ever occur, and if they do occur it is somebody’s fault, and equally behind the notion that the Feds can squeeze quality into the system simply by demanding it to be so. Therefore, any doctors who openly objects to these new, tough quality measures will reveal themselves to be both anti-quality and low-quality doctors.

Rather, DrRich will refer back to the true mission of this blog, and simply explain to his readers how this new “never event” strategy furthers the true mission of Medicare and the insurers, which is to say, the covert rationing of healthcare.

For covert rationing is the chief operating principle of both the Feds and the private insurers. Indeed, their behavior resembles nothing more than the behavior of the closet, white-collar narcotic addict: while smiling their pasty smiles and desperately pretending to us that all of their new initiatives are only concerned with quality and nothing else, in reality, with every ounce of their being, their devious minds are constantly inventing new schemes to manipulate, deceive and twist each and every opportunity into some means of scoring their next covert-rationing “hit.”

Consequently, we cannot go wrong if we ask, every time we see some new healthcare program ostensibly aimed at quality improvement: Where’s the rationing?

One might think the rationing in this case is easy to spot. After all, if the feds stop paying for “never events” that actually cannot be avoided, they will save dollars right up front simply by refusing to pay for services rendered. But Medicare itself has estimated that its up-front annual savings from its original list of “never events” will be only about $20 million. And that seems hardly worth the effort.

The real savings will come from a place far more sinister than that.

The “never events” initiative – just as the Feds insist to us – is aimed at changing physicians’ behavior. But quite predictably, that behavioral change will not be in the arena of quality improvement (since no amount of quality improvement can stop “never events” that are inevitable). Rather, the behavioral change will be in the arena of risk avoidance.

While it is unlikely that doctors will ever refuse to care for high-risk patients who are experiencing genuine medical emergencies, it is quite likely they will stop recommending elective medical therapy for high-risk patients. Patients who seem particularly prone to infection, bed sores, falls, blood sugar abnormalities, blood clots, delirium, or who seem likely to need intravenous antibiotics (which predispose to C. difficile) will be particularly targeted. Roughly speaking, these patients will include diabetics, the elderly, anyone with a clotting abnormality or a history of blood clots, the obese, people with immune disorders, and the chronically ill. Physicians know by experience and instinct the sorts of patients to whom they ought to avoid offering elective medical services.

But in an era of evidence-based medicine, it is inevitable that savvy doctors will not want to rely on instinct and experience in this important matter. In order to conduct their risk avoidance in the most cost-effective way, they will want to base it on firm statistical evidence.

Accordingly, it is notable that investigators reporting in the Archives of Surgery last year began the important work of providing the kind of evidence-based risk avoidance which today’s physician actually needs. They published a large study designed to show which sorts of patients are most likely to experience post-operative “never events.” To the authors’ credit, their article was not written with the overt goal of providing a roadmap for risk avoidance. Instead it was written to show that “never events” are not really “never events” at all, but rather, are sometimes unavoidable complications; and that in certain readily-identifiable and (and obvious) subpopulations of patients, the incidence of “never events” is particularly high. That is, the authors were trying to convince the Central Authority that its policy on “never events” is far too Draconian, and that some leeway ought to be made for doctors who care for these higher-risk patients.

But of course the Central Authority already knows this, and also knows that the public fully supports its “never events” policy just as it is. The Central Authority, DrRich suspects, will see the Archives article for what it will end up becoming – a roadmap for surgeons who want to avoid the risk of encountering career-threatening “never events.” DrRich thinks Central Authority is quite satisfied with this study, and hopes to see more like it.

Conducting a risk/benefit analysis is nothing new to doctors. Doctors have always computed a risk/benefit analysis before recommending elective services to their patients (such as hip replacement, coronary artery bypass grafting, back surgery, gall bladder surgery, anti-obesity surgery, &c.) And in making those risk/benefit estimates, they have always taken into account the increased risk of complications faced by the elderly, the sick, the fat, and the malnourished.

But now, the “risk” part of the risk/benefit analysis suddenly must include three important new risks, and this time they are risks to the doctor him/herself, and not to the patients: 1) If any of these complications occur, no payment will be made for the (often very expensive) treatment the complication will require; 2) If a complication occurs, another “never event” will be tabulated in the federal database next to the doctor’s (and the hospital’s) name, which will inevitably show up in a public report card; and 3) Such a complication, previously considered a predictable risk, will now engender malpractice suits, based on the declaration by the Feds that these “never events” always constitute, by definition, grievous examples of poor-quality medicine.  The Archives article serves to place this new variety of risk analysis on firmer ground, and as such is an important new addition to the medical literature.

Lest anyone think that doctors would not really stop recommending clinically indicated care to patients just because of the personal risk it would entail, remember that it’s already happened, and is well documented. The government and the insurance companies have already conducted that experiment; it’s been completed, the results have been tabulated, reported, and duly noted. It turns out that doctors, like most other people, respond quite logically to negative incentives.

CMS knows exactly what it’s doing here.

Some might wonder why America needs a new book on fixing our healthcare system, now that the the Patient Protection and Affordable Care Act (i.e., Obamacare) has already done that for us. Well, there are several reasons, so take your pick:

1) Obamacare might be repealed.
2) Obamacare might be found unconstitutional.
3) If Obamacare is permitted to proceed into its full glory, it shouldn’t be long before it leads to social upheaval either by: a) exploding the federal deficit far beyond even what we’re seeing today; or b) alarming a critical mass of Americans regarding the new, oppressive powers which the new law grants to the federal government.

If 1 or 2, the process by which our nation will re-address healthcare reform may look much like the contentious, but deliberative, processes we have used in the past to reform certain aspects of our society. If 3, the process may look a lot more like Egypt.

In any case I think there is a reasonable chance that, in the next few years, we may be looking for a completely new way to reform our healthcare system, one that resembles neither Obamcare, nor the alternate and rather tepid “solutions” that have been proposed by the Republican leadership.

When that day comes, you will be very glad you took the time to read Douglas Perednia’s new book, Overhauling America’s Healthcare Machine – Stop the Bleeding and Save Trillions.

Perednia, something of a polymath, is an internal medicine specialist as well as a dermatologist, an NIH researcher, a writer, and an expert in telemedicine and medical informatics (he is a professor of this latter discipline). While he has founded and directed non-profit organizations, he is also an entrepreneur (which explains how he has become “New Zealand’s sole domestic source of boiler cleaner and glue for beer bottle labels”). He admits also to being a tap dancer (not that there’s anything wrong with that). And, as anyone will know who reads his excellent blog, Road To Hellth, he also knows a lot about the healthcare system.

Perednia’s book is a true tour de force – but don’t let that frighten you away. The author’s writing style is clear and conversational, easy to follow and entertaining to read.

In this style, he tells you everything.

Perednia does not pretend that American healthcare isn’t in dire need of the very kind of fundamental change that President Obama says he wants, nor does he pretend that a little insurance reform will do the trick. The healthcare system, he suggests, is on its last legs. It is a machine that is wearing out and bogging down, and it needs to be completely overhauled.

The healthcare machine is far more complex than it ought or needs to be. It is burdened by all manner of extraneous flywheels, gears, and gewgaws that were glommed on during its long history to please one long-forgotten constituency or another, that do nothing useful, but that consume a lot of fuel and deposit a lot of grime. The healthcare machine’s great creaking clockwork grinds away against all this unnecessary friction and accumulated grunge, and for all its strenuous efforts produces an ever-smaller amount of useful work. What this machine needs is more than some bright new attachments and smarter operators to oversee its churnings. It needs to be torn down and rebuilt.

Perednia does not pull his punches. He starts by showing that the American healthcare system, when its output is analyzed objectively and soberly, does not produce nearly as much good as its present apologists suggest. It certainly does not produce very much good in relation to all the money we spend on it. He then moves on to analyze the roles all the big players have within the healthcare system in producing all this waste. He amply demonstrates how the doctors, the hospitals, the insurers, the government (and, yes, the patients), behaving in a manner that is entirely consistent with the incentives the system has provided for them, with no especial evil in their hearts, and with no more than the natural, baseline amount of greed and self-interest that accompanies any human enterprise, operate in a grotesque ballet of waste and excess. He shows how the healthcare machine has reached the point where it simply cannot go much further, and that, like it or not, we’re going to have to do something about it. (Along the way, Perednia clearly demonstrates how Obamacare, far from representing any kind of fundamental departure, simply exaggerates the pathology.)

The strongest part of this book, however, deals with how to fix all this. Perednia begins by establishing what almost anyone would agree ought to be the goals of the American healthcare system – it must deliver effective and efficient healthcare services in a manner whose fairness to all Americans is commensurate with the contributions all American make to it, and it must be financially sustainable – at least to the point that its cost does not drive us to societal collapse. He then outlines a scheme that can achieve these goals.

I would be less than forthcoming if I did not mention that the broad outline of Perednia’s solution, as he graciously acknowledges, derives from my own book. That outline looks like this:

He proposes a 3-tiered healthcare system. The bottom tier, Tier 1, consists of self-pay healthcare. All individuals would be expected to pay a certain amount each year toward their own healthcare, say $2000 per individual, or $4000 per family. The funds for Tier 1 could reside in a Health Savings Account, which the individual would own. People with low incomes would have HSAs funded by the government. But everyone has the opportunity to own an HSA, and everyone controls the first $2000 of spending on their own healthcare (and keeps what money is not spent).

Once the individual exhausts their annual $2000 limit, their healthcare would default to a publicly-funded Universal Health Insurance Plan (Tier 2). The universal health plan – which would cover every American, even members of Congress – would operate under a system of open healthcare rationing, for the purpose of keeping public spending on healthcare on a reasonable budget. Perednia spells out the details on how such open rationing could be accomplished. Obviously, establishing any system for openly rationing healthcare would be a very difficult and exceedingly painful process. It seems very likely that only after experiencing great gouts of pain from our current healthcare system could we Americans be enticed to tackle such a thing. But Perednia (and I) postulate that such a circumstance may become manifest in the very foreseeable future.

Tier 3 is a completely voluntary, self-funded insurance product. Here, the health insurance industry would offer various levels of additional health insurance to people who want it, which will pay for services not covered under the open rationing in Tier 2. Health insurance in Tier 3 would begin to look like an actual insurance product (i.e., one that protects individuals against unforeseen, potentially catastrophic expenses), instead of the soup-to-nuts coverage of everyone’s heart’s desire that now passes for health “insurance.”

Again, this is just an outline. While my book did not take it much farther than this, Perednia takes his solution to the healthcare problem several steps beyond, and provides a very comprehensive plan. He discusses specifics of insurance reform, physician reimbursement, paying for goods and services, physician credentialing, government regulation, malpractice reform, addressing fraud and abuse, implementing electronic medical records that actually help efficient patient care (a particularly strong section of the book), and assuring that innovations in healthcare are encouraged. If you really want to know how to fix American healthcare, it’s all here.

Once Omamacare is repealed or declared unconstitutional, or once it goes forward in tact to accelerate the final implosion of our already-near-terminal healthcare system, smart people will find themselves looking for new ideas upon which to re-build American healthcare. Amidst all the cacophony about healthcare reform, however, there are really only very a few voices that are offering truly novel solutions. Doug Perednia has thrust himself to the front of that short list of visionaries with Overhauling America’s Healthcare Machine.

Please read this book, so that when the time comes you can tell your Congressperson (or perhaps by that point, your local Commissar) about it.

____

Overhauling America’s Healthcare Machine is available in all bookstores, and at Amazon.

DrRich has said many times that clinical science is among the least exact of the sciences, and therefore, the results of clinical research are particularly susceptible to “spinning” by various interested parties, in order to yield the kind of results they would prefer to see.

Until recent times in American medicine, the parties who have been most interested in spinning clinical research have been the people who run drug companies and medical device companies (who need clinical research which supports the use of their products), and the medical specialists (who are more likely to be paid for performing medical procedures that are supported by clinical research). In writing about such data-spinning abuses, DrRich has particularly targeted his own Cardiology Guild, but only because he knows and loves cardiologists the best. He suspects that other specialists are doing exactly the same thing.

While DrRich has used reasonably gentle humor (laced, to be sure, with sarcasm and irony) to criticize doctors and their industry collaborators for twisting clinical data to their own ends, others have expressed the same concerns in much more indignant terms, and have threatened to employ professional sanctions, civil and criminal penalties, and everlasting perdition, to curtail such behaviors.

(Indeed, DrRich has always suspected that the real reason President Obama has not closed Guantanamo is so he has someplace to send recalcitrant American physicians who persist in accepting logo-ed plastic pens from drug reps, or who refuse to accept reduced Medicare/Medicaid reimbursement schedules, or who engage in the black market healthcare activities the President surely understands he is provoking. The one thing that can torpedo Obamacare completely is if American doctors refuse to go along, and any physician who shows signs of doing so will have to be dealt with harshly – if not by detention in exile, then by some other method.)

There is nothing wrong with a little old-fashioned American Puritanism, of course, and physicians and companies who behave badly ought to be punished. But DrRich begs his readers to understand that the inevitable bias in clinical research is not one-sided; it cuts both ways. And clearing the field, so that the only entities which are left to spin clinical research data will be the government-controlled expert panels, is a very bad idea.

DrRich must remind his readers that Obamacare provides for several distinguished expert panels, to be appointed by the executive branch of the federal government, to direct the studies, interpret the results, and apply the results to official reimbursement policies, of a species of clinical research which is called “comparative effectiveness research.”

Comparative effectiveness research comes in two flavors. First, there is the comparative effectiveness research whose unambiguous goal is to compare the clinical effectiveness among different treatment options, so as to offer physicians objective guidance in making the clinical decisions whose results are more likely to be clinically favorable to their patients. This kind of comparative effectiveness research is an unalloyed good, and it is as unassailable as babies and bunnies. Then there is Comparative Effectiveness Research (CER), which is to be operated by new government bureaucracies, whose agenda regarding what kind of effectiveness is actually to be compared is intentionally ambiguous, but which at the end of the day will be comparing cost effectiveness, as opposed to clinical effectiveness, so that doctors will make the clinical decisions whose results will be more favorable to healthcare cost containment.

Our policymakers have been studiously ambiguous about what they mean by  Comparative Effectiveness Research.

This ambiguity was made clear during the Obamacare debates when Peter Orszag testified on behalf of the administration before the Senate Finance Committee. When queried by skeptical Republicans on the ultimate goal of the proposed CER boards, Mr. Orszag was evasive. Specifically, when asked by Senator Kyle (R-Arizona) whether the CER board would be empowered to make decisions regarding which medical services will be reimbursed, Mr. Orszag finally replied, “Not at this point,” a reply which did not alleviate the suspicions of the minority party.

To state the ambiguity more plainly, it is clear that while the government’s CER panels will mainly be concerned about comparing cost effectiveness, the only kind of effectiveness they are willing to discuss publicly is clinical effectiveness. This studied ambiguity allows proponents of Obamacare to paint opponents of the CER panels as being against the “babies and bunnies” form of comparative effectiveness research, and thus reveal those nay-sayers as being beneath contempt, and unworthy of anyone’s attention. Meanwhile they will be free to advance their real “cost effectiveness” agenda.

Therein, of course, lies the government’s bias regarding clinical research. Since clinical research is the primary mechanism by which Obamacare proposes to cut the cost of healthcare, and since the new government panels provide the chief mechanism for controlling and applying the results of that clinical research, the government will be strongly biased toward research results that point toward the less expensive of the two treatments that are being compared.

The idea that government-controlled expert panels will be unbiased, of course, is so absurd that nobody can plausibly believe it. Where you go wrong, dear reader, is in believing that their bias can only take them so far; that clinical research, being science, will more or less yield the Truth; that while a biased party might shade things a bit in this direction or that, at the end of the day the answer which is reached will approximate the Answer.

In fact, clinical research is inherently biased, from the moment a research study is conceived. And those who conceive of, plan, conduct, and analyze the clinical study have every advantage. (This, indeed, is the very reason why everyone is so indignant about the studies conducted by medical industry and their minions in the medical academy.) That advantage is now, under law, defaulting to the government panels.

To be sure, many clinical researchers believe in their hearts and souls that bias can be eliminated through the use of randomized clinical trials (RCTs). In such trials, “like” groups of research subjects are divided randomly into two or more groups, and each group receives (for instance) a different therapy, whereupon differences in outcomes among the groups are attributed to the different therapies to which they were randomized. Indeed, the widespread belief that RCTs are the necessary and sufficient means to achieve “clinical truth” has become so deeply ingrained within the medical establishment that when anyone (such as DrRich) says otherwise, he immediately reveal himself as a scientific Neanderthal.

DrRich has previously observed that the widespread belief in RCTs has become like a Cult, whose creed can be reduced to three main tenets:

1) Data derived from randomized clinical trials represents Truth.
2) Data derived from non-randomized trials represents Falsity.
3) If you don’t believe this, you are a heathen.

Objective observers will find it at least a little ironic that an attempt to claim the scientific high ground has so obviously resulted in a new religion, replete with its own dogma.

The sad truth is that the results of RCTs are invariably dependent on the bias built into their design, and even if internally they are statistically legitimate, they can often send us down the wrong path.

Those who design RCTs (the smart ones, at least) know this. Like smart trial attorneys, they know the answer before they ever dare to ask the question. So they tailor their “question” in such a way as to yield the answer they want to get. Indeed, if a lawyer should end up asking a question in court that produces an unexpected answer, he or she is completely incompetent and ought to be sued for legal malpractice. In more cases than one might think, the same is true for those who design RCTs.

So, for instance, if you are a payer and want to limit the use of an expensive therapy, you design your RCT so that enrolled patients likely to respond to the therapy are diluted with a broad population of enrolled patients, many of whom are less likely to respond to the therapy, to assure that the average response of the whole population will be quite small. (In many instances the clinical characteristics of the likely responders and the likely non-responders will be reasonably apparent.)

On the other hand, if you are a company that wants to encourage the use of your expensive new product, you design an RCT that preferentially enrolls the relatively small subset of patients who are very likely to respond favorably, and then trust the marketplace (with a tweak from your DTC advertisements) to “extrapolate” the results to broader categories of individuals.

So RCTs do not eliminate statistical bias, as the dogma suggests. Rather, they simply offer an opportunity to control the statistical bias in your favor. Since most doctors (and most regulators, guideline writers, and reporters) don’t seem to get this, it becomes relatively easy to fool them.

What DrRich is saying, with regard to the government panels that will direct and interpret the CER (panels that will determine who gets what, when and how, and who gets paid for it and who doesn’t), is that even if those CER panels were not overtly biased against high-cost medical care, eliminating bias from their clinical research would be impossible. And given that the CER panels are being created expressly for the purpose of reducing high-cost medical care, the bias will likely become extravagant. But since that extravagant bias will be couched within the results of various RCTs, the Cult of Randomization will be invoked as “proof” that this expensive medical treatment is no better than that cheaper one.

DrRich has illustrated numerous times how the results of RCTs can be twisted and spun by interested parties, whether by private or government interests, to achieve the results one wants. The CER panels will (it seems obvious) become masterful at doing this.

The apparently widespread notion that industry-sponsored research is invariably biased, while government-sponsored research is entirely objective – and that therefore, the only thing we need to assure accurate clinical research is to have it all controlled by the government – is astoundingly naive.

DrRich believes that, since we cannot possibly eliminate bias from clinical research, we are more likely to approach the actual Truth if we: a) encourage clinical research by all parties – the government and private entities – so that, at least, we may be more likely to engender a “balance” of results; and b) insist that all clinical research be conducted with complete transparency, so that not only are the results made available to anyone who wants them, but also a complete accounting of all the other aspects of the research – including the study design, conduct of the study, and the analysis of the data.

Since bias cannot be eliminated from CER even if the federal CER panels wanted to (and they decidedly will not want to), then insisting on complete and total transparency (ideally, even to the point of making the raw data itself accessible), will be our chief defense. DrRich assumes, since covert rationing will undoubtedly be the CER board’s main, though unspoken, agenda, that such transparency will not be forthcoming without a fight.

Transparency will be worth fighting for, however. At least some bias in clinical research is unavoidable, so complete transparency is our best defense against the biased application of the results of clinical research, whether it is conducted by companies or CER panels.

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DrRich entered medical school 40 years ago with every intention of becoming a general medical practitioner, and indeed he became one. But after only a year in practice as a generalist, he found himself so frustrated with the frivolous limitations and the superfluous obligations that even then were being externally imposed on these supposedly revered professionals, that DrRich altered course and spent several years re-training to become a cardiac electrophysiologist.

(Electrophysiology is a field of endeavor so arcane as to be mystifying even to other cardiologists. DrRich hoped that the officious regulators and stone-witted insurance clerks would be so confused – and possibly intimidated – by the mysterious doings of electrophysiologists that they would leave him alone. Happily, this ploy worked for almost 15 years.)

Still, DrRich has always held general practitioners (now called PCPs) in the highest regard, if for no other reason than these brave souls – unlike DrRich himself, who cut and ran at his earliest opportunity – have stuck it out.

But, as we all know, the practice of primary care medicine is today in crisis. Today’s PCPs are mostly looking to get out as soon as they can afford to do so, and today’s medical students are avoiding primary care in droves.

But not for the reasons most often claimed.  DrRich’s contention is that doctors are abandoning primary care medicine for reasons that actually have relatively little to do with low pay and high educational debt. The real reasons have much more to do with the fact that primary care medicine has been systematically and purposefully demeaned and diminished, to the point that it has become nearly an untenable choice for most doctors.

Accordingly, every now and then DrRich likes to point out – for the edification of his readers – some of the ways in which this fundamental devaluing of primary care medicine is being accomplished.

And so, here’s another reason it sucks being a PCP:

PCPs whose patients fail to quit smoking are now at risk not only of being publicly labeled as low-quality physicians, but also of being sued.

To see how this works, dear reader, DrRich asks you to place yourself, for a few minutes and for the sake of empathy, in the position of a modern American PCP.

As a PCP, one of the major banes of your existence is the struggle you must make during each and every “patient encounter” to get through a long Pay-for-Performance Checklist (different checklists for different patients, depending on their insurer). Completing these checklists, within the 7.5 minutes that have been graciously allotted to you for such encounters, is of course critical in order to demonstrate to the appropriate healthcare accountants the adequacy of your performance as a modern, high-quality American physician.

One item that invariably appears on each of your mandatory checklists, doctor, has to do with counseling your patient on smoking cessation. It’s likely you may have thought this to be one of the less objectionable mandates you must accomplish during each patient visit. After all, you can get through your well-rehearsed pitch on smoking cessation in 20 seconds or less (unless you are dealing with one of those rare patients who is actually serious about trying to quit), and thereby make up some of the precious time, from your 7.5 minutes, that you have already spent achieving some more challenging check mark (trying, perhaps, to talk a diabetic patient into taking the extraordinary steps necessary to get his hemoglobin A1c down that last 0.5% to target).

So: 20 seconds spent on smoking cessation. Check.

But whoa. Not so fast there, Dr. Welby.

Did you know there are guidelines for physicians on smoking cessation? Did you know that these guidelines were devised under the auspices of the federal government, by a committee of individuals who are anti-smoking zealots (not that there’s anything wrong with that)?

From this latter fact, of course, there are certain things you will already know about these guidelines before you ever see them. You will know that the guidelines must be very long and detailed and tedious, because a) they are federal guidelines, and b) they are devised by people whose one and only mission in life – a mission they clearly believe is far more important than, say, oil spills, terrorism, global warming, jobs, or achieving fine and durable erections upon demand – is to save the world from the scourge of smoking. And now, these zealots have been granted the authority (i.e., the federally-approved authority to generate medical guidelines) to make it your primary mission in life, too.

Now, doctor, have a peek at the actual guidelines, which you can find here. Notice, first, that the federal guidelines for physicians on smoking cessation are 196 pages long. Notice how they step you through the process of counseling, and then step you through each of the measures you must take in order to guarantee that your patient achieves total success. And notice that an early branch point in the process of counseling is the one where the patient informs you whether he/she is willing to go any further with efforts at smoking cessation; and notice further that when the patient concludes that he/she is indeed NOT willing to go any further, thank you very much for your concern, the guidelines do not relieve you of further immediate obligations – no – but instead specify additional interventions you must now, at this moment, embark upon with this unwilling patient, which are “designed to increase their motivation to quit.”

The brash sales techniques required of you by the federally-sanctioned smoking-cessation guidelines would embarrass even a telemarketer, or an annuity salesperson.

This, of course, is all to say: Your 20-second spiel on the evils of smoking just doesn’t cut the mustard, doctor. To really earn that smoking-cessation chit on your P4P checklist, you need to do a lot more than that. The 196 pages of deadly serious federal guidelines detail what that is.

Lest you are tempted to dismiss as an absurdity the expectation that you are actually supposed to cram 2 hours of anti-smoking counseling into a 7.5 minute patient visit, there’s one more thing you ought to know.

One John Banzhaf, Executive Director and Chief Counsel for Action on Smoking and Health (ASH), who bills himself as the “law professor who masterminded litigation against the tobacco industry,” is not taking lightly, doctor, your obvious laxity in following federal guidelines on smoking cessation. Accordingly, some time ago he sent letters to each of the 50 state health commissioners warning them that he will soon begin instigating medical malpractice suits, on behalf of smokers who continue to smoke as the result of their doctor’s refusal to follow federal guidelines to the letter.

Mr. Banzhaf informs the commissioners that “physicians are killing more than 40,000 American smokers each year by failing to follow federal guidelines.” That’s right, doctor, you’re killing them. (Cigarettes don’t kill people; people kill people.) Specifically he invokes your sacred obligation to “warn the smoking patient about the many dangers of smoking and provide effective medical treatment for the majority who wish to quit.” (Emphasis DrRich’s.) That is, it’s your job not just to counsel them and treat them, but also to see that they actually succeed in quitting. If you don’t follow this mandate, you’re killing them. And you must pay.

When the federal government takes the pains necessary to draft detailed management guidelines for physicians, guidelines that, if followed as written, will save tens of thousands of lives each year, then surely society has every right to expect you to follow those guidelines to the letter – and to save those lives.

This is such a brilliant scheme for ending smoking-related death and disability, one must wonder why it hasn’t yet been applied to other intractable medical problems. Just think of all the good that could be accomplished, for instance, by federal guidelines requiring PCPs to assure that each of their patients maintain an optimal body weight, follow an exemplary diet, exercise vigorously for at least an hour a day, maintain unfailingly positive attitudes, and work diligently at their allotted tasks each and every day (secure in the knowledge that adopting right thinking and right behaviors will be invaluable to our dear leaders, as they bravely go forth to assure the good of the whole).

In any case, doctor, consider these anti-smoking guidelines carefully next time you’re putting that little check mark next to “Smoking cessation counseling” on your P4P checklist, and ask yourself: “Have I really done all that I am obligated to do, under the law, to guarantee that this patient has lit up his last smoke?”

Making PCPs responsible for their patient’s personal choices and behaviors, of course, is a time-honored method of covert healthcare rationing. It gives doctors powerful incentives to invent mechanisms for avoiding patients who display obviously unhealthful lifestyles, thus making it relatively inconvenient for these patients to gain access to expensive healthcare services.

But more to the point of this post, it is yet another example of how micromanagement by politicians, activists and bureaucrats has come to infest the practice of primary care medicine, and to relegate PCPs to the diminished role of simply following the checklists continually produced by such as these. If this is what primary care medicine has come to at last, why would you expect anyone who has a choice to take such a career path?

DrRich, for one, does not believe the 10-15% increase in pay hinted at by Obamacare will change the calculus for PCPs very much, and in fact, if it does – given all that is being done to primary care medicine – we should all be very much distressed by the implications.

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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!

DrRich is not smart enough to predict what specific bribes, threats or subversive parliamentary maneuvering will finally win passage of the President’s healthcare reform. However it comes about, DrRich thinks the result will be bad.

DrRich arrived at this opinion through a long process, lasting many years, that changed his thinking on the proper role of our government in our daily lives. One key event within this long process, which he related in his book, first opened DrRich’s eyes regarding the essential benignity of our government as it administers its assumed role as guardian of the people’s healthcare.

DrRich reproduces this vignette here:

One afternoon in June of 1994, I was summoned to a meeting by a vice president of the hospital for which I worked at the time. Meetings, especially unannounced ones, are the bane of employed physicians; but this one, I was led to understand, was mandatory.

I found the meeting room filled with high-ranking hospital administrators, hospital attorneys, and my clinical chairman. A gathering of luminaries such as these, especially on short notice, was decidedly rare. As I walked into the room all eyes were on me. I knew all these people; they’d been my friends and colleagues for years. We’d been fighting the healthcare wars side by side. But now they studied me as if seeing me for the first time.

“Who died?” I asked, just to break the ice.

“To be determined,” responded one of the lawyers.

They got right down to business. The chief hospital attorney explained: The federal government, in the guise of the Office of the Inspector General (OIG), had launched a major investigation of allegedly improper Medicare billing practices related to the use of investigational implantable cardioverter defibrillators (ICDs) in the late 1980s. This investigation, I was told, had begun as a whistleblower law suit out on the west coast, and the feds were now expanding their inquiry. The OIG had just subpoenaed records from approximately 120 of the largest hospitals in the country that implanted ICDs. We were one of the 120.

Now I understood why I was here. As Chief of Cardiac Electrophysiology, research with the ICD was one of the major endeavors of my career. The ICD is a device that is designed to prevent sudden death in patients whose cardiac disease makes them susceptible to such an event. Once implanted, the ICD recognizes the sudden, lethal heart rhythm disturbances that cause nearly instant death, and automatically delivers a shock to the heart to restore it to a normal rhythm. It is a remarkably effective device, and was obviously so from the very beginning. Seldom, in fact, has a more dramatically effective life-saving therapy ever been devised for any illness or disease. For this reason, as long as I had access to these devices I (and most electrophysiologists), felt morally obligated to offer them to any eligible patients who were at high risk for sudden death.

So now I understood why I had been summoned to the meeting. What I didn’t understand was why the Feds thought we’d done anything wrong.

“We shouldn’t have any problems there,” I protested. “You’ll recall that we looked into the legality of billing for ICDs back in ’87 when I first started working here. And Medicare said it was okay.” While I was an employed physician (and so the hospital handled all the billing for my services), I’d had enough concern about billing Medicare for investigational devices that I’d insisted the hospital get clarification from our Medicare Intermediary (the local agent and representative for Medicare) on the matter.

One of the attorneys answered. “That’s right. The Medicare Intermediary indicated at the time that there was nothing illegal about billing for the ICDs, but couldn’t guarantee they’d pay for them. As it turns out, they’ve paid for each one we’ve implanted, and never questioned our using them.”

“Then what’s the problem?”

“Medicare now says we’ve been in violation by sending the bills,” the lawyer replied. “There’s apparently an obscure instruction in the Intermediary’s guidebook that prohibits billing for some investigational devices.”

“But we got clearance from the Intermediary,” I protested.

“And that’s the defense we’ll take. The Intermediary itself didn’t know about this instruction. But unfortunately, Medicare operates a little like the IRS. If you call the IRS with a tax question and they give you bad advice, it’s your fault if you follow that advice. The fact that the Medicare people were unaware of their own rules, and apparently told us the wrong thing, doesn’t absolve us.”

“So what’s the worst case scenario?” someone asked. “That we’ll have to pay all the money back?”

“The monetary penalties are much worse than that,” intoned the CFO. “We’re looking at over 100 investigational ICDs that the good doctor here has implanted,” he said, glaring at me. “And at about $25,000 each, that’s a pretty penny right there. But the Feds are also talking about a $10,000 fine per incident, plus triple damages, so we’re really looking at several tens of millions of dollars we can’t afford. What’s worse, the fact that the OIG joined the whistleblower’s actions suggests that they’re going to claim we intentionally violated Medicare regs – which could mean jail time.” He was looking at me again when he said “jail.”

“Don’t worry,” a vice-president said to me sympathetically. “We’re all in this together. We’ll help you as much as we can.”

“What do you mean, you’ll help me?” I shot back. “I just work here. You do all the billing, keep everything you collect, and pay me a paltry salary.”

“Like I said, we’re all in this together. But those bills do go out under your name, Dr. Fogoros. As far as Medicare is concerned, they’re your bills.” As I’ve since learned, when the feds begin pointing their fickle finger, it’s customary for everybody to dive for cover.

For the next two years my life was plagued by a series of complex machinations – legal probes and parries – made in response to the Feds’ investigation of our supposed “fraudulent” submission of bills. I won’t bore you with the details – I’ll just hit a few highlights.

First, my hospital threw in with two dozen other large hospitals from all over the U.S. that were also affected by the OIG’s subpoena, and together we hired a fancy inside-the-beltway law firm that specialized in healthcare law. These attorneys ultimately determined that the obscure regulation the OIG was invoking against us had itself been illegally promulgated, and therefore should not be enforceable. Accordingly, our hospitals sued Donna Shalala, Secretary of Health and Human Services (HHS) in federal court to prevent her from enforcing this obscure, previously unknown, and (we held) illegal rule. “We have maybe a 50-50 chance of winning this suit,” I was told by one of our attorneys, “but it won’t be settled for years.”

While all this was going on, the subpoenaed hospitals also lobbied Congress to act on the essential unfairness of it all. “Look,” the hospitals said, “we’ve got one agency of the federal government (Medicare) coming after us for doing research that had been duly approved by another agency of the federal government, the Food and Drug Administration (FDA). We need laws to make the Feds behave consistently. When the FDA approves clinical research, Medicare should allow patients to avail themselves of that approved research.” Finally, in November of 1995, Congress passed just such a law. “So we’ve won!” I exulted when the hospital attorney called me with the good news. “Not exactly,” was the reply, “The OIG prevailed on Congress not to make the law retroactive. So the OIG is still coming after us for what they say we did in the 1980s.”

Then, in January of 1996, the Feds launched a new attack. Senator Roth, Chair of the Senate Finance Committee, decided it would be in somebody’s best interest to have a showcase hearing, highlighting the grievous crimes against Medicare that are being promulgated by avaricious physicians and institutions like me and mine. So the Permanent Subcommittee on Investigations sent subpoenas to the CEOs of several hospitals from the OIG’s list of 120, mandating that they appear before that committee on Valentines Day (i.e., heart day) to answer questions regarding the allegations that we’d committed Medicare fraud in our use of the ICD. It was to be a real circus – it was to be covered on C-SPAN, with major networks in attendance and lots of national publicity. The works.

Immediately, there was a mad rush to have the subpoenas quashed. All the hospitals from states whose Senators were members of the Finance Committee managed to be excused from appearing. At the end of the day, only four hospitals remained. Mine was one.

I was sure my career had ended. My family, friends, patients and colleagues were about to see the CEO of my hospital appearing before a hostile Senate Investigational Committee answering questions on the Medicare fraud that I supposedly had committed. I knew it didn’t matter that I hadn’t done anything wrong. Truth is only a compilation of some facts, whereas perception is everything.

I spent two days in Washington helping the fancy beltway lawyers prepare our CEO for his testimony. I failed miserably in my emotional pitch to be allowed to testify in his stead (the CEO had been subpoenaed, not me; and besides, anyone who seemed eager to testify before Congress must be crazy enough to get us in trouble). But at least I managed to convince the CEO that we should take a hard line with the subcommittee. After all, we had truth, righteousness, ethics, and possibly even the law on our side. We shouldn’t allow ourselves to be intimidated.

Each witness was to be permitted to read a statement into the record before the questioning began. Our attorneys had prepared a 10-page statement that was vague, wishy-washy, filled with legalese, and as nearly as I could tell, didn’t deny wrongdoing as much as it promised we’d be more careful next time.

So I prevailed on the CEO to tear up this lawyered-up document and instead use a one page statement that I wrote for him, saying, in essence: 1) We implanted investigational ICDs in Medicare patients because they were at high risk of dying without them, and to withhold such life-saving devices when they were available to us would have been unethical and would have constituted malpractice. 2) Before implanting the investigational ICDs, approval for their use was obtained through the FDA. 3) Before billing for the investigational ICDs we asked for and received clearance to do so from our Medicare Intermediary. 4) The records and documents we sent Medicare in support of our billing for these ICDs clearly indicated that the devices were investigational, and yet Medicare reimbursed us each time, over a period of several years and without questioning our actions or our bills. 5) The rule Medicare is now invoking was unknown to us during this period of time, and also, apparently, was unknown to the Medicare Intermediary. 6) In any case, as we have asserted in federal court, that regulation was illegally promulgated, and is therefore not a legal rule. 7) Congress has agreed that regulation to have been at least an ill-advised one, as evidenced by the fact that Congress recently passed legislation that now renders that regulation illegal, whatever its previous legality. 8] If they now assert that our actions constitute fraud, then the message the OIG, Medicare and the Senate subcommittee is sending to the public is that doctors and hospitals are expected to discriminate against the elderly, and will be called to task by the federal government if they refuse to do so. 9) Thank you for your attention.

The hearing was indeed quite a show. The whistleblower himself was the first witness, and he entered the chamber wearing a hood to hide his face, sat behind a screen, and spoke with his voice electronically distorted. This was the first time in history, I was told, that a witness had appeared before Congress disguised in this way, except in hearings featuring Mafia turncoats, drug lords, and the like. The implication, I presume, was that I and my fellow cardiac electrophysiologists were no less evil or potentially violent than other, more famous sorts of felons; and that if we learned this guy’s identity his life wouldn’t be worth a nickel.

Then it was us perpetrators’ turn to testify. The CEOs of the other three subpoenaed hospitals, after reading their lengthy, lawyerly and seemingly contrite statements into the record, were grilled mercilessly by the Senators of the subcommittee. Our CEO was the last witness. Once he read our brief but much more aggressive statement, the Senators seemed not to have any substantial questions for him. His testimony was over almost before it had started. Our hard line had paid off.

One more blessing occurred on that day. Somebody apparently found some Whitewater documents that weren’t supposed to have existed, so ten minutes before the hearing, C-SPAN pulled out and went running down the hall to televise the Whitewater doings. All the other news media went with them. Our hearing, despite the big build-up, the dramatically disguised whistleblower, and the fact that it was Valentine’s Day, barely made the news. The lack of national news exposure (and as a result, the lack of local news coverage) spared my reputation and that of my hospital.

Then finally, later in 1996, a federal judge ruled in our favor in our suit against HHS – the regulation Medicare was invoking, the judge ruled, had indeed been illegally promulgated. The OIG still didn’t give up, but in the end offered a settlement deal to the hospital for a mere million or two (which, by this time, was less than we had already spent defending ourselves), and nobody would have to admit to wrongdoing or go to jail or have a criminal record.

DrRich is not complaining. This episode could have turned out a lot worse. And the whole ordeal provided him with enough amusing anecdotes to last a lifetime. But having the Feds coming after him for more than two years was truly an eye-opening experience.

As DrRich sees it, the rightness of his actions seemed completely obvious. He had used those ICDs because his high-risk patients needed them, and from every indication their usage was legal and proper. But, in the service of his patients he had failed to discover a vague, obscure and difficult-to-interpret rule that existed in the Medicare Intermediary’s guidebook (a guidebook to which he had no access). As a result DrRich had been caught up in the Fed’s great anti-fraud initiative.

For over two years DrRich could never be sure of what was going to happen to him. There were periods of days at a time, usually just after another round of legal punches and counter-punches, when there was little else he could think of. (Would he lose his job, his career, his reputation, all his worldly possessions – would he go to jail?) During those times DrRich was of little use to anybody – colleagues, family or patients.

Of course, in the end it all turned out just fine – but the reason for the favorable outcome wasn’t that the Feds finally agreed that DrRich’s actions had been appropriate and non-fraudulent. It was because his lawyers had found a legal technicality in the Fed’s own actions. Had it not been for this entirely fortuitous discovery, who knows what might have happened?

So DrRich has seen a side of the Feds that most doctors have not, and he is willing to admit to a more robust paranoia on the subject than most would have at this moment. The way it looks from here, the government – at least sometimes – is willing to go to great lengths to prove just how rife with fraud is our healthcare system, and, once the Feds set their sights on an alleged perpetrator, they are pleased go to equally great lengths to bring that supposed perpetrator down. At least sometimes they’re willing to base their prosecution on bad rules that are poorly written, illegally promulgated, and hidden away in obscure manuals; they’re willing to ignore the fact that the alleged perp had relied on advice from the Feds’ own agents before proceeding; they’re willing to summon that perp before a televised, circus-like inquisition to be publicly humiliated for actions that, just a few months earlier, they themselves had passed explicit laws to endorse; and they’re willing, when all legal justifications for their persecutions have at last been taken away, to make a final demand, that some might consider extortionate, for a cash payment before they’ll go away.

At least, that’s how it looks from here.

It is not DrRich’s position that the Feds have been engaging in an unmitigated orgy of illegitimate anti-fraud activities over the past dozen years or more. He is sure they have not. Indeed, most of the anti-fraud activities the Feds have undertaken have undoubtedly been legitimate and useful. Furthermore, DrRich fully understands that any get-tough government initiative – whether it be anti-fraud or anti-terror – has got to have teeth, and that it is natural if regrettable that occasionally, a few innocents will be ensnared in such efforts. DrRich admits the possibility that his frightening experience may represent nothing more than the collateral damage that will naturally happen whenever the sovereign power finds it necessary to wield its great hammer in the overriding interest of the public good.

But forgive DrRich if he believes it is more likely that the experience he has just related represents instead an early glimpse into the government’s methods of intimidating and controlling doctors who, without these kinds of necessary checks, will, in caring for their patients, simply keep doing whatever they’d like with the government’s money. DrRich happens to believe that the utter unpredictability, arbitrariness, doggedness and seeming absurdity of the government’s actions in his own case was not accidental. These techniques are essential to the Feds’ goal of keeping their prey (i.e., physicians) intimidated, completely off balance, and in their thrall.

As evil as we all know the health insurance industry to be, DrRich (and any physician who knows anything about it) would much rather attempt to appeal to/defy/maneuver against/manipulate private insurers for the benefit of their patients (since the worst these entities can do is withhold payment), than do anything whatever – either for the patient’s benefit or for any other reason – that would risk engendering the enmity of the great, slavering, merciless sovereign authority.

Just a thought, as we embark on our new government-controlled healthcare system.