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While Grand Rounds is normally the highlight of everybody’s week here in the medical blogosphere, this time it’s different. This week, we are all – each and every one of us  – completely distracted by the most wonderful sense of expectation and joy, to the exclusion of virtually every other human emotion. For DrRich, at least, the feeling puts him in mind of the giddy anticipation he experienced on, say, his 5th Christmas eve, when he was still young enough to consider Santa Claus a magical-but-real agent of earthly delights. (This was before DrRich realized that Santa, being obese, is actually a great menace to society.)

For this, dear reader, is the week when President Obama will turn his considerable powers of intellect, at long last, to the issue of jobs. The President indicated to us more than a month ago that he would, in his own good time, present to us his program for fixing the horrific and prolonged unemployment problem which now affects most American families in some way. And thus realizing that a solution is finally at hand, we in the great unwashed masses have waited, as patiently as we could, through earthquakes, hurricanes, Martha’s Vinyard vacations, and numerous pre-season football games, for the President to tell us the Answer. And, summoning together a Joint Session of Congress – a venue most often reserved for declarations of war and similar life-altering policy initiatives, thus confirming the momentous nature of his coming words – he will finally proclaim to us the Good News, a mere two days from now. One can cut the anticipation with a knife.

So, while it is indeed an honor to be hosting Grand Rounds during this historic week. DrRich must admit to finding it a little difficult to concentrate his efforts. No doubt readers will likewise find it a challenge to turn their attention away from the Big Event long enough to peruse the following posts – the best of the medical blogosphere this week.

But be assured that there is good stuff to follow. So, if you find yourself incapable of focusing your attention on Grand Rounds at the moment, simply bookmark this page, and return to it once your sense of soaring happiness returns (as it inevitably must) to a more normal state. Be assured that this week’s entries are timeless enough to outlive your ecstasy (an emotion which – alas! – to be effective, must always be transient).

So let us begin.

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DrRich – having been informed not long ago, by an actual U.S. Attorney who at that moment had him under a form of official duress, that the DOJ is well aware of this blog and the general tenor of its content – always likes to mention early in any long post (so that his minders do not have to read the whole thing) any items that might be helpful to the Administration. Accordingly, we open Grand Rounds this week with the announcement, posted in The Examining Room of Dr. Charles, of the 2011 Charles Prize for Poetry. Dr. Charles has been hosting this prestigious contest – which seeks and awards excellence in poetry touching on health, science or medicine – for some time now, and it has proven to be an exceedingly popular annual event.

In addition to the significant intrinsic merits that accompany the Charles Prize for Poetry, DrRich must note that Dr. Charles is also awarding a not-inconsiderable cash prize to the winners. That is, he is creating what, in our present economic environment, must be considered damned-near jobs. Encouraging employment in the career of poetry is something, DrRich thinks, the President should seriously consider before Thursday night, lest he be tempted to make the huge mistake of attempting to whip up enthusiasm yet again for Green Jobs. (In the wake of the collapse just last week of the heavily-government-subsidized and heavily-Obama-promoted Solyndra Company, and of at least two other companies that received large federal funds for Green Jobs, treading that dead ground again would merely reveal that he is entirely bereft of ideas.) The Administration ought to thank DrRich, and especially Dr. Charles, for this critically important advice. Encouraging poesy, instead of Green Jobs, would demonstrate the kind of new thinking we are all looking for from our President at this critical juncture.

At Dr. Malpani’s Blog, Dr. M. outlines his 3-step approach for helping his patients understand the intricate concepts of in-vitro fertilization. First, you describe how the thing is supposed to work when everything is functioning normally (the “thing” in this case being the human reproductive system). Then, you describe to the patient where the system is breaking down in his/her case. And finally, you describe the options available for mitigating the breakdown. Dr. Malpani’s system, which he points out is generalizable, is aimed at creating a consensus for action when faced with a complex problem.

DrRich will only remark that Dr. M’s system, which works well enough for problems based in human physiology, is proving pretty worthless for problems based in the more social sciences, such as economics. This is because of a fundamental disagreement, among the debaters, on how the economy is “supposed to work when everything is functioning normally.” Progressives and conservatives have very different ideas about this. So Dr. M’s approach, which requires both logic and a fundamental consensus on what constitutes “normal” behavior, is unsuitable to non-physiologic systems.

Dr. Val at Better Health posts a recent interview with Dr. Dori Carlson, president of the American Optometric Association, regarding the importance of screening children for subtle but significant vision problems. (Dr. Val and Dr. Dori are referring here to the kinds of vision problems that involve optics, and not the kind suffered by our political leaders.) The type of gross vision screening which is conducted by most schools misses the majority of these vision problems in children, and those undetected vision problems not infrequently lead to impaired learning. Also, they often lead to misdiagnoses and inappropriate treatment, likely including the misdiagnosis of ADHD. (Missed vision problems constitute only one of the causes for the explosion in ADHD diagnoses in recent years. A more common cause, in our overly-feminized schools, is being a boy. Indeed, as nearly as DrRich can tell, being a boy today is a disease; they have drugs for it and everything.) In any case, if you are a parent of a school-aged child, you should strongly consider having your child’s vision checked by an ophthalmologist or optometrist – especially if somebody wants to put him on Ritalin.

Henry Stern at InsureBlog tells us the good news and bad news about a new study related to heart attacks. He notes that heart attack victims are receiving definitive therapy in American hospitals much more quickly than they were just a few years ago. And when you are having a heart attack, minutes count – the longer that coronary artery is occluded, the more permanent damage is done to your heart, and the higher your odds of death or disability. So the diminished delay to treatment is good news. As usual, though, there is bad news attached. DrRich, always the sunny optimist, does not wish to repeat the bad news. You can go to the InsureBlog to read it for yourself.

The ACP Internist reports a study showing that 80% of today’s doctors look up on-line information in front of their patients. DrRich, who admits to being an Old Fart, does not find this surprising, since young physicians these days are, well, young. And young people are on-line all of the time, reporting their every trivial thought and mundane action instantaneously to the Cloud. (If Andy Warhol were alive today he’d be talking about our 15 minutes of anonymity.) But you don’t have to be a young doctor to take up these new habits. It appears from this new survey that doctors of all age groups have ritualistically placed an LCD screen between themselves and their patients. In so doing, they have awarded to those distant, expert panels – the ones spinning out all those guidelines, pay-for-performance checklists, marching orders, &c – their appropriate and rightful physical position, that is, directly interposed between doctor and patient. This is more than mere symbolism, but the symbolism is delicious.

But, dear reader, please do not be too critical of today’s doctors. If you yourself were a savvy modern physician, realizing that you could go to jail if you do what you think is medically appropriate before checking with the Authorities to find out if it is also allowable, you’d have a computer screen in front of your face too, and you’d be looking stuff up in front of your patients the entire time they were blathering on about their symptoms or whatever. DrRich worries for the 20% of doctors (likely, his fellow Old Farts) who haven’t “gotten it” yet.

Beth Gainer at Calling the Shots makes an important observation about the two classic narratives to which all victims of breast cancer are assigned – the narrative of the triumphant hero, and the narrative of the courageous and noble victim. Ms. Gainer’s observation is that most women with breast cancer do not fit either of these prescribed narratives. Many women are thus left feeling guilty or diminished when they find that their experience is not meeting with society’s expectations. Ms. Gainer is absolutely correct, and indeed, her observation is generalizable. The same thing occurs whenever society’s designated narrative-makers assign a range of permissible attitudes, thoughts and behaviors to any defined group. Mercy on any member of the group who falls outside those designated norms.

David E. Williams at the venerable Health Business Blog addresses the question of how we – society – will cope with the next big trend in the drug industry – the development of “niche” drugs, drugs that are suitable for only a relatively small number of patients and which, therefore, are exceedingly expensive to develop and market. David goes directly to the real question – the problem of niche drugs makes the issue of healthcare rationing unavoidable.

So far, of course, we are doing our healthcare rationing covertly, and in the case of niche drugs that usually means interpreting clinical results in such a way as to minimize their potential benefits. We do this by saying that Drug X “only increases survival by 4 months,” and ignoring the fact that “4 months” is an average value, and that while many patients have no benefit at all, a non-negligible minority may live a lot longer. The question, “Is it worth $50,000 for only four more months of life?” is different from the question, “Is it worth $50,000 to have a realistic shot at living several extra years?” Covert rationing causes us to frame the question in such a way that the answer to any question beginning with “Is it worth. . .” is always, “no.”

At the Road to Hellth, Douglas Perednia, one of the best analysts of health policy writing today, looks at the rationale for the onerous penalties which are required under Obamacare for hospitals whose patients are readmitted at higher than the average readmission rates. Perednia describes the bogus math which the Feds are apparently using to determine what appropriate readmission rates ought to be – and points out the irony of requiring doctors to behave in an “evidence-based” fashion, while the Feds themselves are using frivolous statistics to dole out the equivalent of the NCAA Death Penalty to our hospitals.

Steven Seay, PhD discusses what ought to be second nature to any clinician – applying the principles of the scientific method to clinical practice. That is: gather the necessary data to formulate an hypothesis; institute therapy based on that hypothesis; measure the results of that therapy; revise the hypothesis to reflect this new data; repeat as necessary. This is the way clinical practice should be done. DrRich is happy to learn that it is still apparently OK for clinical psychologists to function in this manner. For physicians, especially PCPs, the scientific method has become forcibly compressed to: make a diagnosis; treat according to the guidelines. While the patient might not do so well with this new method, the physician will be OK, since “quality” will be measured according to one’s compliance with the guidelines. Measuring the actual results of the treatment, of course, would only lead to trouble, and in most cases will be avoided.

James Gault, MD, of the blog Retired Doc’s Thoughts, is a long-time champion of classical medical ethics (as opposed to the New Age medical ethics now formally espoused by all the major professional organizations).  As such, Dr. Gault often deconstructs arguments being published by modern medical ethicists supporting these New Age ethics, which require doctors to act for the benefit of the collective rather than for the benefit of their individual patients. In this post, Dr. Gault gives a very effective what-for to Professor Fuchs of Stanford, who, once again, has published a paper advancing the bankrupt argument that what’s good for the collective is necessarily good for the individual. These kinds of vapid arguments may fool the Whippersnappers, but they’re not fooling us Old Farts.

The ACP Hospitalist notes that, according to the Institute for Safe Medication Practices, a “grey market” is developing for life-saving medications that have been in severe short supply for the past few years. A grey market, DrRich thinks, is like a black market, but less illegal – though it is possible they are referring to Old Farts who are merchants. In any case, the ISMP says the grey market is price-gouging hospitals that need those important drugs, and have nowhere else to buy them. The solution, according to the ISMP, is (among other things) to empower the FDA to manage drug shortages and tighten regulations for drug distribution.

The growing, widespread shortage of important medications is indeed a bad problem. We should look for a solution to this problem. Shortages of any product occur when it costs companies more to make the product than they can get for it in the marketplace. Onerous regulatory policies by the FDA which, in the name of product safety, have greatly increased the cost of doing business for pharmaceutical companies, along with recent de facto price controls on generic drugs, have combined to make it economically unfeasible for drug companies to expend large resources to manufacture these drugs. It seems doubtful that piling on even more regulations will improve the situation. And attacking the grey markets will simply drive them further into the dark (since black markets are nature’s way of providing a product when governments act to limit it). Given the expected 500,000 pages of new regulations being conjured up out of the Obamacare legislation, drug shortages are merely the first of many critical medical shortages we will be seeing in the coming years. So it will be instructive to watch how our leaders handle this problem.

In any case, from the job-creation standpoint, DrRich believes there will be many employment opportunities in coming years in sundry black markets related to healthcare. Many skills will be needed, some of which should be quite exciting!

At the Prepared Patient Forum, Trudy Lieberman writes a post entitled “Health Insurance, Meet the Jolly Green Giant,” in which she discusses the new, patient-friendly labels that are supposed to accompany health insurance policies under Obamacare beginning no later than 2014. The labels sound like a good idea, but as Ms. Lieberman points out, there will be problems. For instance, for the Feds to mandate transparency in labeling is unlikely to be all that helpful when, at the same time, they often mandate utter secrecy on the part of providers (for instance, in creating severe anti-trust penalties for doctors who reveal the fees they have negotiated with insurance carriers). But as always, results are far less important than simply meaning well.

Sharp Incisions, a blog written by a self-described “fledgling” medical student, has sent in an affecting post about scrubbing in on a unique surgical case – the harvesting of six vital organs for transplantation from a patient who has been declared brain dead. DrRich prays that Dr. Incisions will maintain for a long time the same sense of wonder and gratitude, expressed in this post, for the gift of life.

A medical student who blogs anonymously at the D.O.ctor Blog, describes her first experience participating in cardiopulmonary resuscitation when it actually counted. DrRich, who in his days as a cardiac electrophysiologist ran hundreds of these things, and who became convinced over the years that three people was the optimal number to run a “code,” admits to being a little taken aback by this student’s description of the event, which sounds like it must have been as complex to coordinate as a Busby Berkeley production number. No wonder she was a little astonished by her experience. DrRich supposes that this must be the new-style CPR mandated by some new guideline or other, and would not be surprised to learn later this week that CPR procedures requiring 15 participants is part of the President’s new Jobs Plan.

Speaking of sudden death, one of DrRich’s recurrent themes here on the CRB is that sudden death is a great boon to our healthcare system (since not only is sudden death itself very cheap, but also it tends to remove individuals who would otherwise continue collecting Social Security, and who tend to have expensive chronic heart disease), and that therefore the government will tend to stifle the prevention of sudden death any time it can. Accordingly, Dr. Wes tells us that the Feds are about to further limit the use of the Zoll wearable defibrillator. Doctors have taken to using this device in high-risk patients during the first month or so after a heart attack, since guidelines specify that ICDs (implantable defibrillators) must not be implanted during this interval. Since sudden death is particularly likely during that first month, the Zoll device is being used as a “bridge to ICD.” Obviously, sudden death being the healthcare system’s friend, this must not be permitted. And so, Dr. Wes points out, soon it will not be.

At the HealthAGEnda Blog of the John A. Hartford Foundation, Marcus Escobedo describes how his father is coping with the decisions that need to be made as he deals with recurrent prostate cancer. Helping elderly patients deal with health issues is the thrust of Mr. Escobedo’s work at Hartford, and his new personal experience, he tells us, drives home the point. Specifically, Escobedo works to assure that elderly patients are considered to be more than just the sum of their disease and their age. DrRich is sorry to have to point out that no less an expert on American healthcare than President Obama has explicitly disagreed with this approach, and on national television to boot. Perhaps when he said this the President was suffering under the influence of teleprompterpenia, and perhaps if he had an opportunity to meet with Mr. Escobedo over a beer in the Rose Garden, he would possibly begin to revise his position to one that is more compatible with the mission of the Harford Foundation. On behalf of America’s Old Farts, DrRich would certainly hope so.

Dr. Thomas Pane writes in the Business, Surgery & Medicine Blog about tantrums, specifically, the kind occasionally thrown by surgeons in the operating suite. His post carries an important Labor Day lesson for anyone who hopes to make a career in the medical field in the coming years, so pay attention:

Everyone can agree that throwing tantrums in the operating room is never a good thing, and that quite often, it is a very bad thing. But Dr. Pane points out that, counterproductive as tantrums often are, they are nonetheless not the worst possible way in which a surgeon can express his/her utter frustration at a bureaucracy that blithely conspires to disrupt surgical procedures at critical moments. He reminds us, once again, that the biggest handicap one can ever have when working in an environment in which bureaucratic mud has fouled every gear is: giving a sh*t. So, while Dr. Pane may or may not agree, here’s the lesson: If surgeons would simply adopt the apathetic, indifferent attitude that classically characterizes long-term survivors in work environments mired by bureaucracy, all would be well.

Jaqueline writes Laika’s MedLiblog, a blog dedicated to medical information science. She submits a post entitled, “PubMed’s Higher Sensitivity than OVID MEDLINE… & other Published Clichés,” in which she shows how medical researchers doing literature searches for, among other things, meta-analyses, will stumble upon various “anomalies” in their searches of the PubMed and OVID databases, and then write additional, CV-padding papers about those anomalies. Jaqueline points out that these so-called “anomalies” are actually well-documented “clichés,” which are well-known to information specialists and anyone else who is competent in doing comprehensive literature searches. In other words, Jaqueline has documented that these meta-analysis researchers are rank amateurs at doing the most critical step in conducting meta-analyses – searching the literature for all the appropriate published studies. DrRich has always mistrusted meta-analyses, and Jaqueline has helpfully identified yet another reason to justify such mistrust. He thanks Jaqueline, and whoever planted those database anomalies which allow us to identify potentially incompetent meta-analysis researchers.

Nicholas Fogelson of Academic OB/GYN writes about taking care of the dying Jehovah’s Witness patient, or rather, taking care of the Jehovah’s Witness patient whose illness is potentially curable but who is dying because he or she refuses to accept blood products. DrRich can attest to how very difficult it is for a doctor to respect a patient’s religion when doing so results in their death. Dr. Fogelson’s description of his evolving attitude regarding this dilemma is compelling.

Need to be uplifted after reading the above post? Read Jordan Grumet’s submission from his blog, In My Humble Opinion. It’s brief and beautifully written, and it reminds us that sometimes our efforts as doctors – which all too often seem futile – can pay off in unimagined ways.

Pranab at the Scepticemia blog points to a news story about a medical school in Mumbai selling seats (that is, entry to medical school) to the highest bidder. He strongly objects to this practice, even though he postulates that his objection will make some of his readers call him “a leftist commie” (which DrRich finds to be the most common kind). DrRich does not agree with Pranab’s (tongue-in-cheek) conclusion that it is America’s fault that Mumbai medical schools are selling seats. (It is actually only George Bush’s fault.) But DrRich does agree entirely that the practice itself is an abomination. Indeed, we can all agree that entry to any career which requires a high degree of skill, talent, and/or intelligence ought to depend on merit, and nothing but merit. Can we not? Good.

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DrRich will end by noting that he is finishing this Jobs! Jobs! Jobs! Edition of Grand Rounds during the waning moments of Labor Day, which causes him to fondly recall those long-ago days of yesteryear, when the U.S. still had plenty of steel mills and DrRich was a card-carrying member of the United Steelworkers of America, and the thought of attending medical school had not yet penetrated his still-empty head. And he recalls how, while he was working one day as a lowly laborer, a union boss came over to him to explain (after DrRich had complained about it) the utility of his spending three painful days moving a large pile of slag, employing only shovel-and-wheelbarrow technology, from one location to another – AND THEN BACK AGAIN.  Now, those were the days when we knew how to make jobs!

Say, whatever happened to those steel mills, anyway?

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In an article appearing last week in the American Heart Journal, investigators concluded that if American doctors would prescribe for their patients with heart failure each of the six therapies which are most strongly recommended in current heart failure guidelines, 68,000 lives per year could be saved.

The following (for the interest of the reader, and for the convenience of any attorneys who may follow DrRich’s offerings), is an ordered list of these six proven, life-saving heart failure therapies, along with the number of American lives that could be saved each year if only American doctors would stop grossly under-utilizing them in violation of published guidelines:

• aldosterone antagonist therapy – 21,407 lives
• beta blockers – 12,922 lives
• implantable defibrillators (ICDs) – 12,179 lives
• cardiac resynchronization therapy (CRT) – 8317 lives
• hydralazine plus isosorbide – 6655 lives
• ACE inhibitors or angiotensin receptor blockers (ARBs) – 6516 lives

The authors, of course, are careful to point out that their analysis is based on statistical methods, and thus must be counted as merely estimates of the magnitude of the benefit that would actually occur should American doctors suddenly begin managing their heart failure patients appropriately. (Their presentation of these estimates to five significant figures implies a level of precision far in excess of what can be justified, and therefore must be an oversight not only by the authors, but also by the reviewers and the editors. But still, one gets the idea. A lot of preventable deaths are being left on the table.)

Several studies have reported, over and over again, that fewer than half of American patients with heart failure are receiving all the treatments available to them that have been shown to reduce symptoms and/or prolong life. Indeed, DrRich, on his patient-oriented heart disease website at About.com, has long urged patients with heart failure to familiarize themselves with all the recommended therapies for their condition, so that when they are with their doctors at least somebody in the room will bring it up.

(Such advice, DrRich reminds his readers – all of whom are likely to be patients one day – ought to be considered generalizable for all American patients with all medical conditions, in an era when doctors are being coerced to ration healthcare at the bedside by omitting mention of sundry available medical services.)

But DrRich’s purpose here is not to address those unfortunate heart failure patients whose lives are being jeopardized by their physicians’ acts of omission. but rather, is to strategize with his colleagues who treat heart failure patients as to how they should respond to this embarrassing revelation that by failing to follow published guidelines, they are killing so very many patients.

After all, only a few months ago, when another research study showed that 23% of ICDs were being implanted outside of published guidelines (even though the large majority of those “inappropriate” implants turned out to be actually indicated, but were performed within a 40-day waiting period that the guidelines specified), not only was this violation played up on the evening news and splashed across newspaper headlines, but also the Department of Justice immediately launched an investigation to determine whether it could bring criminal charges against implanting physicians. That is, failing to follow recommended guidelines to the letter is now not merely suboptimal medical practice, but also criminal behavior.

And how much worse than implanting indicated ICDs a few days earlier than the government would prefer, is behavior that causes the unnecessary deaths of 68,000 people a year? It seems to DrRich to be quite a bit worse.

So should American doctors who treat patients with heart failure be feeding their Swiss bank accounts, changing their identities, and stocking their lean-tos in the Montana backcountry?

DrRich brings good tidings – there is no need for you to overreact. The Feds cannot possibly prosecute all deviations from all clinical guidelines. Not only would that be unfeasible, it would also be counterproductive. And deviations from the heart failure guidelines are just the kind of deviations from which the Feds are inclined to look the other way.

We must remember that the primary directive of the American healthcare system, whether it is run by insurance companies or the government, is to ration healthcare covertly. Covert rationing means withholding whatever medical services you can, from whatever patients you can, whenever you think you can get away with it. If one remembers this simple rule, one can accurately predict the response of the health insurance companies or the government to any particular guideline violation.

So: When doctors implant expensive ICDs outside of the guidelines, even when the deviation is to place an indicated ICD a few days earlier than specified, it is a potentially criminal offense. Those ICDs cost a lot of money, and worse, prevent inexpensive sudden deaths, so it is clear that steps need to be taken to prevent their usage. Enforcing the guidelines to the letter therefore is imperative.

On the other hand, when deviations of guidelines result in NOT spending money (say, on drugs, ICDs, and CRT devices), those deviations will  be viewed quite differently. And when those same guideline deviations result in the premature deaths of tens of thousands of patients with chronic and expensive medical conditions (and who, had they survived for another five or 10 years, would have consumed lots and lots of extra healthcare dollars and, in most cases, Social Security payments), the last thing you would want to do is to engage in guideline-enforcement activities.

If you doubt DrRich on this point, ask yourself whether you’ve been treated to news stories over the past 10 days on how American doctors are killing 68,000 people each year by failing to follow guidelines. That story, it seems to DrRich, would be much sexier than the one that made a splash in January about ICDs being implanted too early. Yet we’ve heard next to nothing about it. These are not the kinds of guidelines violations we need to put a stop to. These guidelines violations do not fit the narrative.

Also, consider the editorial that accompanied the article in the American Heart Journal last week. It constitutes a strong apologist argument for violating the heart failure guidelines. It points out, rightly, that perhaps there were good reasons that some patients with heart failure do not receive all six of the recommended therapies, and that not all guidelines are applicable to all patients. It also points out that the number 68,000 was estimated by compounding several assumptions together, which would place large error bars around that estimate. So perhaps the guidelines deviations were not as lethal as the authors estimated. But most striking of all, the editorialist argues that it would just be too expensive to follow the guidelines for all patients with heart failure.  If ICDs were used in all patients for whom the guidelines say they should be used, for instance, this alone “would divert most of the money anticipated for all heart-failure care next year to these devices.”

The editorial is correct, and it is honest. It, at least, openly acknowledges that doctors are obligated to ration healthcare, based on costs, at the bedside, and that following these guidelines would violate the imperative to ration. Current guidelines on heart failure would cost a lot of money up front, and would result in the prolonged survival of a lot of very expensive Americans. And therefore, doctors will not be held accountable for failing to follow them.

American doctors can continue deviating from the heart failure guidelines, secure in the knowledge that their activity (or inactivity) will not capture unwanted attention from the Feds. These are not the guidelines our leaders are talking about when they assure the population that they are going to make sure that doctors are doing all the things the experts specify they should be doing.

These are those other kinds of guidelines.

If you are an American patient with any kind of medical problem whatsoever, DrRich begs you to become an expert in your medical condition. The patients with heart failure who are doing so, and who are prepared to challenge their doctors on their treatment, are among the minority who are receiving all the therapies proven to prolong their survival.

The implantable cardioverter defibrillator (ICD), an incredible feat of visionary medical science blended with cutting edge engineering, a device responsible for saving thousands of lives a year, has gone from being a prototypical American success story to a symbol of healthcare excess. Today the ICD is widely castigated by the press, the public, the insurers, the government, and even most doctors as the poster child for expensive and wasteful medical technology. Consequently, the ICD and the doctors who implant them have become fair game for whatever the Central Authority wishes to throw at them. DrRich has explored this fascinating phenomenon in this series of articles;

How ICD Implantation Guidelines Are Being Abused

The DOJ Investigation of ICD Implanters, and What It Means

How the ICD Became an Abomination

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When DrRich decided to become an electrophysiologist over 30 years ago, it was because he wanted to help figure out how to prevent sudden death.  Sudden death from cardiac arrhythmias is estimated to kill over 300,000 Americans each year, and at the time, some of the more recent victims of sudden death had been DrRich’s friends or loved ones. Because cardiac arrhythmias – even the lethal ones – can virtually always be stopped if appropriate interventions are available, these deaths can be prevented, at least in theory. DrRich wanted to help turn the theory into reality.

In 1982, by virtue of being in the right place at the right time rather than by virtue of his own qualities or qualifications, DrRich’s electrophysiology shop at the University of Pittsburgh became the third institution in the world (after Johns Hopkins and Stanford) to gain access to the highly experimental implantable defibrillator. The gradual development of the implantable cardioverter defibrillator (ICD) from a primitive and often dangerous device that was suitable only for the very highest-risk patients, to the finely-tuned life-saving instrument it is today, is an amazing story in itself. Perhaps some day DrRich (who was in the thick of it for two and a half decades) will try to tell it.

But the bottom line is that today we know how to prevent sudden death. And if the evolution of ICDs were permitted to follow the path which is followed by most modern technologies, these devices could, relatively quickly, become small enough, simple enough, safe enough, effective enough, and cheap enough for the kind of widespread usage which would be necessary to actually produce a large reduction in those 300,000 deaths per year. The ICD companies all know how this could be accomplished, and for that matter, so does DrRich.

But alas, this is not going to happen. ICDs will remain extraordinarily complex and expensive devices, which can only be wrestled to ground by highly-trained electrophysiologists (EPs), and which therefore will only be available to a very tiny proportion of the people who could benefit from them. And rather than being celebrated as the typical American success story of harnessing vision, persistence, and innovation to solve a very difficult problem, ICDs instead are widely castigated (by the press, the public, the insurers, the government, and even most doctors) as a symbol of excess, as the poster child for expensive and wasteful medical technology. (And so, when the DOJ goes after ICD companies and the doctors who implant them, the press and the people cheer them on.)

While most EPs and all of the ICD companies refuse to see it, ICDs – a remarkable technology which prevents an all-too-common tragedy – have become an abomination in the eyes of our society.

There are many reasons for this. DrRich will list just three of them, in ascending order of importance.

The third most important reason ICDs are an abomination is: The Toxic Symbiosis Between ICD Companies and Electrophysiologists.

EPs were important during the initial years the ICD was being developed, since expertise regarding complex cardiac arrhythmias had to be translated into engineering language, and then packed into the ICDs, in order for these devices to work the right way. But at some point in the 1990s, ICD companies should have realized that EPs had made their contribution, and were now leading them out on a limb.

Once the fundamental problems in building ICDs were solved, the companies should have been working to make their devices simpler to use, more reliable, and cheaper, so that they could be used by more doctors in more patients. Instead, following MBA Dictum Number One, they “listened to their customers,” the EPs. And the EPs (for whom, like most medical specialists, turf protection is very high up on their priority list), unfailingly counseled the ICD companies to make these devices more and more complex, so that only EPs can understand how to use them. And so, this is what the ICD companies did.

As a result, today’s typical ICD has extra leads (wires) which add appreciably to the difficulty and the risk of implanting these devices, without adding much practical value for most patients; and they have incorporated literally tens of thousands of programming options, ostensibly so that device function can be carefully “tailored” for the individual patient, but which are seldom actually used profitably, and whose chief effect is scaring off non-EPs.

By “listening to their customers,” ICD companies have been led away from simplicity and into unnecessary complexity, and today’s typical ICD is burdened with layers of grotesque tailfins, running lights, oversized tires, and massive engines. In building their vehicles, the ICD companies should have solicited the needs of the typical commuter; instead, they consulted only with monster truck enthusiasts, and so they are producing vehicles that are not suitable for highway use.

The second most important reason ICDs are an abomination is: Government Price Controls (As Usual) Are Keeping Prices High.

The price of ICDs, fundamentally, is determined by Medicare. Way back when ICDs were first approved for use, Medicare determined that a fair price was somewhere in the range of $15,000 – $25,000. This high price was justifiable back in the 1980s, since it cost nearly that much at the time to make one of these things. But the way government price controls seem to operate, ICDs will probably remain in this price range forever.

Now, to be sure, the government does not directly determine what companies get paid for ICDs. Rather, they indirectly determine the price by deciding what hospitals and physicians will be reimbursed for implanting ICDs – and the ICD companies subsequently are paid by the hospital. Those Medicare reimbursement rates apparently vary substantially from region to region and hospital to hospital (who knows how the government determines these things?), and the various rates are not publicly available to DrRich’s knowledge. But ICD manufacturers, at worst, can impute the reimbursement rates by figuring out the top price which specific hospitals are willing to pay them for ICDs (hence the range in prices).

Having determined the top price they can possibly get paid for ICDs, the only logical strategy for manufacturers is to figure out how they can always get paid that top price for every device they sell. They do this by making ICDs specifically aimed at keeping the decision makers happy. And the decision makers, as we have seen, are the EPs.

EPs, having (so far) successfully protected their turf, most often decide which patients get ICDs, and they decide which company’s ICDs to implant. So, to be competitive among their customers, ICD companies must cater to the wants and needs of EPs, and so must produce a steady stream of new, improved ICDs whose novel features are requested by these very high-end, high-maintenance physicians (who again, are dedicated to turf protection through complexity).

Since their product therefore grows more complex with each succeeding generation, in response to the “needs” of their customers, ICD companies have been able to successfully argue to Medicare that ICD reimbursement should be maintained at high levels (and in some cases they have been successful in getting reimbursements to increase even further).

All the ICD manufacturer needs (and wants) to know is: what new geegaws do I need to add to my next generation of ICDs in order to make them even more stupefyingly complex, so as to maintain the loyalty of my EP customers, and to justify high reimbursement rates?

And this is why, despite the fact that ICD technology has been fully mature (says DrRich) for at least a decade now, which in a functional market would cause the price to plummet, the cost of ICDs remains so high. Whatever has developed in the complex interplay between ICD manufacturers, EPs, hospitals and the government, it’s not a functional market.

In fact, there are no market forces at all in play here. Furthermore, there is no evil-doing. The “players” in this scenario – CMS personnel, ICD manufacturers, and EPs – are all simply behaving logically, and are all responding as anyone would to the incentives that have been established within a system which employs government price controlls to keep costs down.

As a result, ICDs remain extraordinarly and unnecessarily expensive.

And the number one reason ICDs are an abomination is: Sudden Death Is Good Public Policy.

A well-known and often-repeated assertion is that 75% (or some similar high proportion) of all healthcare expenditures are consumed during the last six months (or some similar brief interval) of life. Whenever this assertion is made, the clear implication is that some means ought to be found to stop wasting all those healthcare resources, once that six-month clock is found to have started. The debates as to how to go about doing this (since the initiation of the six-month clock can really only be determined retrospectively) often become very nasty, very quickly.

In this light, consider sudden death. Sudden death has the virtue of being completely unexpected – and therefore very cheap. Victims of sudden death will not have spent the last six months of their lives selfishly consuming all our healthcare resources. Likely, they will have spent that time earning money, consuming goods, and paying taxes. These patriots are doing what every healthcare policy expert agrees we should all do – to go directly from being productive citizens to six feet under. For sudden death is free, and if everyone did this we wouldn’t have a healthcare crisis at all.

Furthermore, consider the kind of patient who receives ICDs. Some of these, of course (probably less than 10%) are young individuals with some sort of genetic propensity for sudden, lethal arrhythmias. But by far, most people who get ICDs are older folks, generally in their 60s, who have underlying cardiac disease. These are people who, if their sudden deaths are prevented, will go on consuming large amounts of Medicare dollars for the maintenance of their sundry significant medical conditions, who will go on collecting monthly Social Security payments, and who, when the end finally does come (possibly a decade or more into their ICD-extended life) will do so in the classic American manner – in an ICU, supported by incredibly expensive machines, drugs, and medical professionals. And thus, thanks to their ICDs, 75% of their lifetime healthcare expenditures will also be gobbled up during their last days.

Consider also that there is no constituency for “sudden death.” There is a constituency for breast cancer; a constituency for HIV-AIDS, a constituency for muscular dystrophy; a constituency for autism; and even a constituency for flatulence. But there is no constituency for sudden death. People who die suddenly (all 300,000 of them per year) generally have no idea that they are likely to become victims of arrhythmic death, and don’t care one way or the other if the means are available to prevent this unfortunate event. Until, perhaps, the last five seconds of their life, they are entirely unaware that sudden death is even a remote possibility.

So the path is open to demonize ICDs and those who build or implant them, and to hound them into curtailing – if not stopping entirely – their counterproductive activities.

While ICDs are indeed too expensive and too complex, the chief reason they are an abomination is that they prevent the very kind of death that every health policy expert understands is the ideal. And they convert that ideal death into a years-long orgy of entitlement-consumption, capped off by a typically American, very non-ideal, very expensive kind of death. Small wonder that ICDs are being specifically targeted by the Feds.

Because of what they do, and not because of their cost, the use of ICDs must be curtailed. ICDs would be targeted even if they were as simple, cheap and reliable as DrRich thinks they could and should be.

ICDs would be targeted even if they were FREE.

Heck, the very concept of an ICD is an abomination.

Podcast:

Two weeks ago DrRich wrote about the abuse of implantable defibrillator guidelines, as illustrated by a recent JAMA article claiming that over 22% of ICD (implantable cardioverter defibrillator) implantations are “non-evidence based.” The abuse of the guidelines, DrRich showed, was perpetrated less by ICD implanters, and more by the authors of that article. That fact being interesting but irrelevant, DrRich went on to speculate that perhaps the Feds would rouse themselves to take this issue to the next level.

It certainly did not take long. Indeed, just a days after DrRich’s post (which ought to completely absolve him of having any direct impact on the Feds’ action), it was revealed that the Department of Justice had already launched an investigation of ICD implants, as related to “proper guidelines for clinical decision making.”

This revelation was made on the website of the Heart Rhythm Society, the professional organization of electrophysiologists (EPs). HRS went on to say that it (HRS itself) had “agreed” to assist the DOJ in an advisory role in its investigation. Furthermore: “Because this is an ongoing investigation, HRS Staff or Leadership is not available for further comment. HRS will communicate additional information to its membership when permitted to do so by the DOJ.” (Emphasis DrRich’s.)

So here’s what we know:

1) The DOJ is actively investigating ICD implantations.
2) Their investigation has to do with the “proper use of guidelines” in selecting patients for ICDs.
3) HRS, the professional organization to which EPs pay huge dues each year in order that it might represent their interests, most especially their interests in Washington, has been preemptively co-opted by the Feds, and indeed has been gagged, so that any further communication to its own membership regarding the investigation is forbidden until further notice.

What will HRS tell the DOJ? It hardly matters, since the important thing has already been accomplished, i.e., effectively silencing the sole organization which represents the interests of EPs in Washington. But, while the HRS statement indicates that the organization is “assisting” the DOJ with “information that does not include either identifiable patient or facility level data,” and while DrRich has no doubt that this is the sincere intent of HRS, DrRich also believes it to be a sure thing that, at the end of the day, HRS (if it wishes immunity from any liability it might find itself subject to, regarding the advice, statements, educational materials, &c., it might have produced over the years, relating to clinical guidelines, or to any other matter of interest that might surface during the DOJ’s open-ended investigation), will tell the DOJ Anything It Wants To Know.

DrRich’s fellow bloggers who are also electrophysiolgists, Wes Fisher and John Mandrola, quickly noted the HRS statement on their respective blogs, and each expressed a certain amount of concern as to the implications of the DOJ’s investigation. But Larry Husten, who writes the excellent Cardiobrief blog, offers a calming voice: “I doubt that the DOJ is gearing up to tackle the vast majority of “reasonable” off-guideline implants. I think they will be going for the real outliers, and when and if they reveal the details of their case there will be little sympathy for their targets.”

Some of DrRich’s readers, who not inappropriately consider him to be a bit paranoid about the Central Authority, may find it surprising that, fundamentally, he agrees with Larry on this matter. He does not think the DOJ will round up large numbers (or even moderate numbers) of EPs who have been practicing basically sound electrophysiology, and who likely have reasonable explanations for any off-guideline ICD implantations they may have committed. DrRich agrees that the DOJ instead will go after a few outliers, figures who – very specifically – will garner little sympathy amongst the public, and indeed, who can be held out, with good effect, for public castigation. Preferably, these figures will be individuals about whom the marketing departments of one ICD manufacturer or another will have generated a few embarrassingly glowing e-mails, celebrating the sheer number of sales these doctors have produced, and discussing strategies – offering speaking engagements in exotic locations, putting on pig roasts, &c. – to keep the ball rolling.

In other words, it is likely at the end of the day the DOJ will produce a few doctors who are truly abusing the system, and harming patients to boot, and who will actually deserve what they will get.

There is no guarantee about this, of course. DrRich has written about how he himself, in his pristine innocence, was once the target of a federal investigation of ICD implants. And while he had on his side the virtues of good medical practice, truth, justice, the American Way, ethics, and even the law, and while he eventually was extricated from his situation with an entirely clean record, it was a close thing, and his escape was based more on luck than on being right. More recently, when DrRich had the “opportunity” to testify under oath in a DOJ investigation on another matter (which he is not yet at liberty to discuss, but regarding which, happily, he was only a witness this time, and not a target), DrRich was required by the DOJ to answer several questions about this very blog and its content, which (as far as DrRich could tell) had nothing whatsoever to do with the matter at hand. By this means DrRich was led to know that the Feds are either among his very great fans (Hi, Fellas!) – or something else.

DrRich’s paranoia, you see, is hard-won, not to mention evidence-based.

So it is indeed possible for innocents to get drawn into such matters – collateral damage is always unavoidable when one is at war – but odds are it won’t be You, or You, or You, so like Larry says, not to worry. They are looking for true evil-doers.

DrRich also agrees with Larry that this DOJ investigation is not a direct response to the JAMA article. The JAMA article appeared a mere week or two before HRS made its announcement – and its announcement obviously was so carefully lawyered-up that it must have taken weeks if not months to negotiate just that one detail with the DOJ. This has all been in the works for a while.  But DrRich does not believe for a moment that the DOJ was unaware that the JAMA article was coming out, or that its content, and the subsequent media attention it would create regarding the widespread ICD abuses being perpetrated by EPs, would dovetail nicely with the subsequent revelation by HRS of the DOJ investigation.

ICDs, and their implanters, have long been a target of the payers – both government payers and insurers – and this new enterprise is merely the latest battle in a long war.

As it happens, DrRich spoke at a certain investigators’ meeting just this past weekend, which was attended by a score or so of prominent electrophysiologists. He can report that the JAMA article (which defined off-guideline ICD usage as bad medicine and harmful to patients), followed by the intense publicity in the media this article generated (also emphasizing bad medicine and harm to patients), followed by the DOJ investigation related to the “proper use of guidelines” in ICD implantation, followed by the co-opting and the gagging of the EPs’ own professional organization, is having a delightfully chilling effect on the profession. DrRich thinks it is unlikely that very many off-guideline ICD implants will be performed for the foreseeable future, no matter how much individual patients might benefit from them, at least while this investigation continues. In fact, while the investigation is ongoing, DrRich suspects that even referrals to EPs for ICD implants will drop off. Because, until then, it will remain an open question just how rigorously one must stick to the letter of the guidelines in order for the DOJ to give one a pass, and to not be considered as guilty of crimes against humanity. The profession is duly intimidated.

Whatever the final outcome of this investigation, it has has already had its intended effect.  DrRich respectfully suggests that the DOJ might just as well take its time with it, and let the effect percolate to perfection.

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Note: Further evidence came this afternoon (January 24) that the effect the Central Authority had in mind is being realized, when Wells Fargo Securities downgraded St. Jude Medical from Outperform to Market Perform. The downgrade was based on WFS’ assessment that ICD implants will be reduced by 10% in 2011, thanks to the DOJ investigation. That reduction doesn’t quite do it, of course, but it’s a start.

Podcast:

Last week the newswires hummed with reports that doctors from all over America are grossly over-utilizing implantable cardioverter-defibrillators (ICDs), much to the detriment of patients themselves (whose persons are being physically violated by avaricious and/or ignorant physicians), and to the hard-pressed Medicare budget (ICDs being so incredibly expensive).

These reports were based on a study appearing in the Journal of the American Medical Association, which analyzed data from the National Cardiovascular Data Registry (NCDR) in an attempt to determine the proportion of ICD implants in the US which constitute deviations from government guidelines. CNN put it like this: “Of more than 100,000 people who received ICDs, almost 23% did not need them according to evidence-based guidelines.” As the lead investigator of the JAMA study told CNN, “It’s a lot of people who are getting defibrillators who may not need them.”

Specifically the new study shows that a full 22.5% of patients receiving ICDs in the US from 2006 to 2009 received them outside of guidelines sanctioned by CMS. Furthermore, patients receiving “non-evidence-based” ICDs had a significantly higher rate of in-hospital mortality (0.57% vs 0.18%, p<.001), and of post-procedure complications ((3.23% vs 2.41%; p<0.001). Notably, ICDs implanted by non-electrophysiologists were significantly more likely to be non-evidence-based than ICDs implanted by electrophysiologists (24.8% vs. 20.8%).

The lead author stressed this latter point to theHeart.org: “Electrophysiologists — who do these procedures day in and day out and are more likely to be more familiar with the guidelines and the evidence that supports ICD use — were significantly less likely to use these non-evidence-based devices.” And an accompanying editorial in JAMA, also written by a couple of electrophysiologists, says that the results of this study indicate that the “intensive training” which electrophysiologists undergo “may improve both the preoperative evaluation of patients as well as the operative and immediate postoperative care of patients undergoing ICD implantation.”

So this study purports to tell us several things: A) Doctors who implant ICDs are surprisingly poor at following clear-cut, evidence-based guidelines; B) As a result, patients are receiving unnecessary medical devices, and suffering unnecessary harm; and C) At least one mitigation for this problem would be to make sure all ICD implantations are conducted by electrophysiologists. Further, ominously implied in some of the news stories regarding this study is the notion that, perhaps, so clear-cut an abuse ought to be looked into by federal prosecutors, similar to cases we have heard of lately involving the abuse of coronary artery stenting.

To all this, DrRich has a few observations:

1) Guidelines are No Longer Guidelines. “Guidelines” implies, literally, a guide, a signpost, a general set of factors that one ought to take into account when making specific decisions regarding specific individual patients. Guidelines are a strong set of recommendations which (all other things being equal) one ought to follow in the majority of cases, and when one chooses not to follow them, one ought to have a good reason for making that choice.

When the use of clinical guidelines is considered in view of this now-quaint notion, one does not expect 100% compliance. After all, patients being patients, they bring to the table lots and lots of special considerations one ought to take into account when deciding how to apply guidelines. Depending on the level of evidence upon which a certain set of guidelines were established, and considering the array of variations on the mean which patients still insist on bringing to a doctor’s notice, the optimal applicability of a given set of guidelines to a given population of patients ought to look something like a bell-shaped-curve. It is not immediately obvious, for instance, that a rate of compliance with a set of guidelines of 77.5% is simply too low. Indeed, a rate of compliance with your typical clinical guidelines well north of that number might imply, when one fully considers the matter, an abrogation of the physician’s duty to make informed clinical decisions based on ALL available evidence, including those introduced by an individual patient’s specific circumstances.

As a matter of fact, the very guidelines regarding ICDs which doctors are now accused of abusing admit that “the ultimate judgment regarding care of a particular patient must be made by the physician and the patient in light of all of the circumstances presented by that patient.”

In this light, a very striking feature of this new report is its baseline assertion that the strict following of guidelines is “evidence-based” practice, while any deviation is “non-evidence-based;” that is, by implication at least, it is good medicine vs. bad medicine. And so, “only” 77.5% of ICD implanters are practicing good medicine, and that is clearly a major concern – one for which urgent solutions should be sought.

It is one thing for the government to insist that doctors follow their guidelines to the letter, or face fines or worse; it is another for physicians themselves to internalize the same paradigm. Where does that leave patients who are relying on their doctors to use their clinical judgment for their own, individual benefit?

Anyway, guidelines are no longer guidelines; they are directives. Even the doctors agree with this.

2) Most of the Patients Who Received “Non-Evidence-Based ICDs” In This Study Actually Were Indicated For ICDs. News reports of this study, and public pronouncements from the authors themselves, imply that patients in this study who received ICDs outside of the guidelines were getting devices that were unnecessary; that their ICDs, which are deemed “non-evidence-based ICDs,” should never have been implanted. This is a misapprehension.

In the large majority of cases, the deviation from the guidelines was simply in the timing of ICD implantation. Patients received their indicated ICDs earlier than the guidelines specify. CMS guidelines say that patients who are indicated for ICDs should not receive them for 40 days after a heart attack, or three months after the diagnosis of heart failure. Most deviations occurred when patients who were supposed to get ICDs got them during the 40-day (or three-month) window.

So the doctors who violated the guidelines were deciding that, for one reason or another, their patients who needed ICDs would be better off receiving their potentially life-saving devices now rather than two or three months from now.

DrRich will leave aside for now the relatively weak evidence upon which CMS based its recommendation to delay ICD implantation following a heart attack or heart failure diagnosis, and simply assert that it is probably the least evidence-based portion of the ICD guidelines, and in fact, the language in the guideline’s supporting documentation, provided by CMS itself, admits to a certain amount of aribitrariness here. (Perhaps DrRich will discuss in detail in a future post the very “interesting” process CMS followed in establishing these ICD guidelines in the first place.)

But even if you buy the notion that the delay prescribed by the guidelines is fully legitimate, there are still many good reasons one might choose not to wait. Perhaps the patient also needs a pacemaker, and implanting a pacemaker now, and subsequently removing it and replacing it with an ICD (which also functions as a pacemaker) in less than 40 days makes little sense. Perhaps the patient will soon be losing her health insurance (not an uncommon situation these days). Perhaps there are features suggesting that the heart failure is particularly unlikely to improve during the next 3 months. Perhaps there are features that imply that a patient has a particularly high risk of sudden death in the near term.

Whatever. The point is that this study does not show that 22.5% of ICD implants are unnecessary. It shows that sometimes ICDs which everybody agrees are indicated are being implanted a few weeks earlier than the Central Authority would like. The NCDR database the authors used to determine guideline compliance did not allow them to assess the legitimacy of the doctors’ decisions to implant them earlier than CMS prescribes.

Back in the 1990s, when the enlightened idea of “medicine by guidelines” was first being promulgated, it was taken as a basic tenet that, after sufficient training and education had been accomplished regarding a set of guidelines, if deviations from the guidelines still exceeded expectations, then it is necessary to consider that there may be something amiss about the guidelines themselves, and the rationale behind the guidelines ought to be formally revisited. But that was back when guidelines were still guidelines, and not directives.

3) The Important Outcome Is Conspicuously Absent In This Study. One can surmise that the main reason doctors implanted ICDs earlier than the guidelines recommend, 22.5% of the time, is that they thought their patient might experience sudden death during the waiting period. That is, they wanted to protect their patient from sudden death now, instead of two or three months from now. Maybe they were just being obstinate, or stupid, but that was their rationale.

This being the case, the critical information we would want to know is whether the early implantation of ICDs might have led to an overall difference in survival. But alas, that critical information is also not available in the NCDR database. So we know (because the authors were quick to point out) that patients who received “non-evidence-based” ICDs had a worse in-hospital mortality (a difference of roughly 0.4%), and a worse post-procedure complication rate. But what was the difference in survival at, say, one year? Did the early implantation of ICDs increase overall mortality (which is the impression the authors and the newswires leave us with), or did it reduce overall mortality by offering extended protection from sudden death? An overall reduction in mortality was, after all, what the physicians intended when they selected a subset of patients they thought would benefit from not waiting for their ICDs. And it is entirely possible that their decisions did just that.

It seems to DrRich that we might want to know this information, before we castigate too severely (or submit for prosecution) the physicians who judged that “early” ICD implantation would be the best approach in a certain proportion of their ICD-indicated patients.

4) Electrophysiologists Can Be As Self-serving As Anyone Else. This last observation saddens DrRich, himself an exceedingly humble and self-effacing electrophysiologist, as his many thousands of great admirers will attest.

The authors of this study – and the editorialists who wrote in the same issue of JAMA – are all among DrRich’s brethren electrophysiologists. All of them seem to conclude from their analysis that ICDs ought to be implanted by electrophysiologists pretty much exclusively, since we EPs are demonstrated to be (thanks to this study) more likely to follow the guidelines, presumably because we are more “familiar with the guidelines and the evidence that supports ICD use,” by virtue of our “extensive training,” our vast experience, &c.

But once again, the majority of guideline “deviations” which were seen in this study were in the timing of ICD implantation, and not in the fact of ICD implantation. In effect, therefore, the authors are arguing that electrophysiologists are simply better at counting to 40 than those other kinds of doctors. DrRich does not find this a compelling argument for instigating an amendment to the guidelines aimed primarily at protecting the electrophysiologists’ turf.

Furthermore, DrRich suspects that the better compliance with the guidelines evidenced by electrophysiologists has less to do with their superior guideline-following prowess, and more with the fact that there tends to be a built-in delay when EPs implant ICDs. Patients with fresh heart attacks and recent heart failure diagnoses are under the care of non-electrophysiologists (many of whom can implant ICDs themselves, whenever they think they ought to), while patients seen by electrophysiologists generally have to first be referred – a process that introduces a fortuitous delay, and thus, of better guideline “compliance.”

Indeed, when one considers this built-in advantage enjoyed by EPs, one must wonder at the fact that, even for patients implanted by electrophysiologists, nearly 21% still received “non-evidence-based” (i.e., “early”) ICDs. This value, statistically-speaking, may indeed be significantly less than the overall value of 22.5%. But practically speaking it is pretty much the same rate of non-compliance. Which leaves one wondering: Why are electrophysiologists – who suggest that they alone ought to be doing these procedures – themselves so lousy at following the central directives?

Perhaps they, too, need remedial counting lessons. Or perhaps they, with their superior intellect and experience and so forth, actually agree with their non-EP colleagues that delaying ICD implantation in all patients with recent heart attacks and heart failure diagnoses may sometimes (roughly a fifth of the time) be counterproductive.

But no matter. Guidelines are guidelines, which is to say, they’re directives. Following them to the letter is good. “Interpreting” them is bad. It is now apparent that even sophisticated physicians, who should know better, have completely bought in to this new paradigm on guidelines favored by our Central Authorities, and appear less concerned about the implications of this paradigm on their patients and on the practice of medicine, than about how to turn it to their own, narrow advantage.

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DrRich hates to be so darned prescient.  On January 19, it was revealed that the Department of Justice has launched an investigation regarding ICD implants, as related to “proper guidelines for clinical decision making.”  DrRich tells electrophysiologists, and other ICD implanters, what to make of this rather scary prospect, here.

Podcast:

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.

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Now, read the whole story.

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

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.