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DrRich has written a lot on this blog about the intentional destruction of the classic doctor-patient relationship. That relationship, of course, was a fiduciary one, under which the patient was encouraged and expected to place full trust in the doctor’s sacred duty to put the patient’s own best interests above all other considerations.

Obviously, such a thing is incompatible with a healthcare system in which doctors are expected to covertly ration healthcare at the bedside. Indeed, it was the ethical tension between what the classic doctor-patient relationship required and the new duties of physicians in the real world, that led professional medical organizations to formally re-define medical ethics in 2002.

And today, of course, under these New Age medical ethics, doctors are no longer expected to place the needs of their individual patient first. Rather, they are required to make the needs of the collective – that is, social justice – their chief consideration.

When the needs of the individual and the needs of the collective coincide, of course, so much the better. But when they do not – and they frequently do not – the needs of the collective take precedence. And “the needs of the collective” are now being determined by panels of experts created under Obamacare, which are busily devising the “guidelines” for treatment that physicians must follow to the letter, or risk their careers, life savings, and freedom from incarceration.

Lest you think DrRich is making this up, allow him to remind his readers of this excerpt, from the ominously-titled book, “New Rules,” co-authored by none other than Donald Berwick MD, who has run CMS for the past 18 months:

“Today, this isolated relationship [between doctor and patient] is no longer tenable or possible. . . Traditional medical ethics, based on the doctor-patient dyad, must be reformulated to fit the new mold of the delivery of health care. . . The primary function of regulation in health care. . .is to constrain decentralized individualized decision making.”

Having thus terminated the classic doctor-patient relationship with extreme prejudice, the same political and medical leaders who conducted this assassination immediately realized they had to fill the void – for how can you have no such thing as the doctor-patient relationship? The solution to this problem, of course, was easy. Just as you can create a New Age medical ethics to fit modern exigencies, you can create a new doctor-patient relationship that will do the same thing.

So, what medical students are being taught today about the doctor-patient relationship has nothing to do with fiduciary responsibilities or ethical obligations. Rather, the New Age doctor-patient relationship is all about the interpersonal relationship between doctor and patient. Doctors are admonished: Be compassionate, be empathetic, be nice. And there’s nothing wrong with crying in front of your patients.

Not being an asshole, of course, has always been a useful trait for physicians. Doctors who can relate to their patients, displaying and actually feeling a certain amount of compassion and empathy, have always been more effective at communicating with their patients – and thus have been more effective physicians – than those who are arrogant, self-centered, aloof, or just plain mean*.

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*DrRich has already pointed out the following irony: many of the doctors who washed out of clinical medicine, possibly because they were too arrogant, self-centered, rigid, and/or aloof to be effective physicians, are now populating the expert panels which are writing the guidelines which will dictate the behavior of doctors who might otherwise be actually useful.
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The benefits of being a nice person are not exclusive to the medical profession. The same rules hold for anyone who makes his/her living by engaging in personal interactions with fellow humans. And so, until recent years, the medical profession categorized this fact (that doctors ought to have decent interpersonal skills) within the realm of common sense, common decency, and common knowledge – and the idea of the doctor-patient relationship meant something else entirely.

Every medical school now has formal training on the doctor-patient relationship, under which young physicians are taught to be compassionate, empathetic, and nice. To the extent that such traits can be taught – and DrRich has his doubts – there’s nothing inherently wrong with emphasizing interpersonal skills. There are, however, two problems that come to mind when emphasizing interpersonal skills becomes a substitute for emphasizing the real and true obligations of a professional.

First, teaching young doctors that a good doctor-patient relationship simply means being nice will result in newer generations of physicians having no concept of any fiduciary obligation to their individual patients. They will address the needs of the collective first, as a matter of course. (But as they withhold information on available treatments about which their patients are not to be informed, we can count on them to be extremely nice about it.)

Second, there is a growing school of thought, amongst those who are responsible for teaching this New Age doctor-patient relationship, that not only should doctors avoid stoicism at the bedside, but they also ought to openly display their emotions, so as to further reinforce their compassion, empathy, niceness, &c. By graphically displaying the deep empathy the physician has for his (or more likely, her) patients, he or she can really bond with them, and thus establish a really strong doctor-patient relationship.

And what better way to openly display one’s emotions than to cry?

Just as a general proposition, DrRich is against crying in front of patients. Certainly, there may be rare occasions when emotions rise up unexpectedly at the bedside – when a patient relates a particularly affecting personal story for instance. But in general, DrRich is convinced that doctors should not make a habit of expressing their emotions too frequently or too luxuriously to their patients.

Empathy and compassion are fine, but what sick patients really need is a doctor who can maintain some sense of composure even when things are the bleakest, some sense that, as bad as things are, this situation is not beyond the doctor’s experience. Even if the outcome is destined to be very bad, the patient deserves a doctor who acts like he or she has been there before, and who they can trust to remain at their side and help guide them through the ordeal that remains.

But DrRich is concerned that the faculty of our medical schools, who are busily training America’s Obamacare Doctors of Tomorrow, have reached the following epiphany: A particularly wonderful way to repair the failing doctor-patient relationship would be to indoctrinate young future physicians (most of whom these days, once again, are said to be women – not that there’s anything wrong with that) that crying at the bedside – indeed, openly displaying their every emotion at the bedside – is a marvelously therapeutic act. Such an open display of the doctor’s emotions conveys a powerful message to the patient, namely, “I care.”

Perhaps. But DrRich thinks crying at the bedside actually conveys two powerful messages to patients:

First Message: I empathize with you. I feel your pain.

Second Message: Your medical condition is so unbelievably dire that not even I can face it with any amount of composure. You, my friend, are well and truly screwed. I cannot imagine the agony you’re in for, without falling apart myself.  May God help you.

It is the conveyance of this latter message that, in the opinion of DrRich, ought to make most doctors on most occasions relatively circumspect about crying in front of their patients.

It is also this latter message that offers to make crying doctors a convenient tool for covert rationing.

When the doctor is reduced to tears (thus graphically demonstrating to the patient that the game’s about up; that there’s pretty much nothing, really, that’s going to change this bleak outcome; and how very sad it all is) – well! Talk about reducing your patient’s expectations!

A chief tenet of covert rationing is that patients who can be made to expect little will be satisfied with little. In most cases this is accomplished by simply coercing doctors to withhold from their patients all of their medical options. But if they can be encouraged to cry when delivering bad news, doctors can destroy patients’ expectations in a much more definitive fashion.

Furthermore, the traditional role of the doctor when a patient’s outlook is poor is to take charge of a very bad situation, and with great empathy, patience and fortitude attempt to guide the patient through that situation with as much skill and courage as possible, even if the final destination looks very bleak. If the doctor instead becomes just one more of the people who gather about the bedside crying about it, then the patient immediately perceives themselves to be abandoned and alone, placed into a position irremediably desolate, with no sense of direction, and no sense of control over their own destiny. Patients fighting illness from such a position do more than merely lose their expectations; they will also die much sooner and in greater despair than necessary.

So obviously, our modern healthcare system under Obamacare will see immediate advantages to encouraging emotional outbursts on the part of doctors. In the name of advancing empathetic physicians and fixing a broken doctor-patient relationship, we could, more easily and more often, get those folks who are in the infamous last six months of life to simply stop striving for a medical miracle – or even for non-miraculous but expensive therapies that actually exist, and that (alas!) might actually extend their survival – and thus effect the sick patient’s demise more quickly and more economically.

Certainly, now that medical schools are teaching forms of alternative medicine that in former years would have made real doctors blush, for courses on the doctor-patient relationship to encourage young doctors to let their emotions free is a good and natural fit.

Young doctors should not be taken in by such ploys. They should empathize with their patients, but remain strong, and lead their patients gently and resolutely through their medical ordeals. They should try to avoid allowing a free display of their emotions to break their patient’s spirit. Their job, instead, is to use their expertise to fortify their patient’s spirit, even in the worst of times. And above all they should not allow themselves to become the trained tools of an ultimately cynical healthcare system, that uses every ploy at its disposal to covertly ration medical care.

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Last week, President Obama took unilateral Presidential action to fix the drug shortages that have been plaguing American hospitals since 2005.

He has been taking unilateral Presidential action quite a lot lately, in his effort to publicly emphasize the recent unwillingness of Congress to do his bidding, and to illustrate to us in the great unwashed how much better things would be if only the President could just go ahead and do all the stuff that needs to be done, without having to take the legislature into account.

For problems like this (i.e., drug shortages, lack of jobs, loss of “spirit,” &c.) are the price we pay when we insist on holding our leaders to the constraints imposed by some old, dusty, outdated document, written by someone else’s ancestors. (For how many of us, really, descend from either the Roundheads or the Cavaliers who wrote the thing?)

There are other ways one might run an enterprise, you know, that Adams or Jefferson probably never thought of.

In any case it is somewhat surprising that this time the President failed to take full advantage of the occasion. Namely, he did not blame George Bush for the drug shortages. He missed a real opportunity there, because had he done so he would have been more correct than usual.

Shortages of certain critical drugs have become a serious problem over the past six years or so. Generally speaking the drug shortages have involved sterile, injectable generic drugs. Sterile injectables are relatively expensive to make, and because the requirement for sterility dictates they must have a finite (and relatively short) shelf life, they are relatively expensive to manage logistically after they are made.

The shortages are in some of the more important and critical drugs used in medicine, including “crash cart” cardiovascular drugs, antibiotics, and important chemotherapy agents used for cancer. In recent years increasing numbers of patients with life-threatening illnesses have not been able to receive the drugs they need to optimize their odds of survival, and they have had to receive some substitute therapy, that is, instead of getting the drug they ought to have, they get a drug that is available. When your life is in the balance this is not a pleasant thing.

The FDA keeps an on-line list of current drug shortages, which can be found here. The list is impressively long.

Many experts (the usual suspects) have looked into the problem of drug shortages, and have come up with many explanations for it. Typically, after analysis, the reason for the shortages is said to be “multifactorial,” and includes: insufficient production space, disruptions in the supply of raw materials, several drug makers opting out of the generic drug business, and a spate of manufacturing quality issues that have resulted in prolonged production interruptions. The term “drug company greed” often hovers just beneath the surface of such explanations, and sometimes actually breaches.

Here is the formal position the FDA has taken to explain the growing drug shortages. Readers will note that it invokes all of the above multifactorials.  (And since none of these manifold causes are under the direct control of the FDA, the agency concludes, clearly it is not to blame.)

This sort of scattershot explanation for the drug shortages seems unsatisfying. It seems unfocused and random. We are to believe that a series of disparate, unfortunate events suddenly began happening to the drug industry six years ago (since prior to that there was no particular problem with these drugs), with no underlying explanation, and that all these unwanted happenstances, quite miraculously, mainly affected only one kind of product – sterile, injectable generic medications. Go Figure.

Must be one of those Black Swan deals.

Undeterred by the lack of a unifying theory to explain the problem, the President has now taken action.

He decreed the following steps.  He told the FDA to ask drug companies for earlier notice when there will be a new shortage. He asked the FDA, after the agency has ordered a halt in production of a drug due to quality issues, to speed up its reviews when the drug company says it is ready to get back on line.  And he asked the DOJ to crack down on “grey markets” that have now appeared to provide these critical drugs to hospitals for exorbitant prices.

See what kind of quick action we would get if we would just suspend the Constitution?

The problem is that the things the President is doing won’t help much, and the things that would help a lot the President is not doing.

It should not be this difficult to figure out why we are having drug shortages. Yes, DrRich agrees that the proximate reasons are multifactorial. But the proximate reasons for product shortages are always multifactorial, because when the root cause of a shortage is itself beyond their control, the product-makers will always try multiple, marginally effective and often counterproductive ways to mitigate the root cause, thus creating a multitude of potential proximate causes for problems. And if an analyst does not look beyond those proximate causes he might not see the root. This often happens when seeing the root would be inconvenient or embarrassing.

The root cause of any persistent product shortage is almost always the same. For one reason or another, the cost of providing the product has outstripped the price the product-maker can get for selling the finished product.

In a free market, when the cost of production goes up the price of the finished product rises accordingly. As long as the customers can pay the higher price there will be no shortage of the product. If the price rises so high that customers won’t pay it, the demand for the product drops – and production is adjusted to reduce the supply in accordance with that reduced demand. But even in this case, there is no product shortage, because even if more product were available nobody would buy it.

Sometimes a sudden increase in demand for a product will create a product shortage. But the higher prices enabled by this new demand will entice the product-makers (greedy bastards!) to increase their manufacturing capacities, and will attract new product-makers to go into business, and eventually the shortage will be resolved. In free markets, shortages are usually temporary and self-adjusting.

In general, truly persistent shortages will only occur when the product-makers cannot increase the price they get for their finished product sufficiently to keep up with a rising cost of production. In this case profit margins shrink or even become negative, and the incentive to expand production, or even to stay in that business, disappears. This is a true shortage – the demand is still there, and customers are willing and able to pay the price being asked, but the product-makers are no longer able to supply the product at that price. Unless the mismatch between the cost of production and the price of the finished product is repaired, the product shortage becomes persistent or even permanent.

Such a persistent cost/price mismatch does not occur in a free market. It occurs when some Central Authority acts to control prices (often, to be sure, while simultaneously acting to increase the cost of production). A Central Authority can cap effective price a product-maker can get for his/her product by implementing overt or hidden price controls; by increasing marginal tax rates high enough to push the product-maker’s risk/reward calculation to favor inaction; and by instituting windfall profit taxes that do the same thing. DrRich is certain that Progressives have thought up a number of other ways to bolix-up the supply/demand relationship as well.

We do not need to know anything in particular about manufacturing generic, sterile injectable drugs to know that it is very likely that the persistent shortages we are seeing in these products are probably due to a persistent, externally-imposed mismatch between the cost of production, and the prices the companies can get for selling these drugs. And whatever caused that mismatch must have occurred before 2005.

And lo and behold! We find that a recent Medicare law (Section 303(c) of the Medicare Modernization Act of 2003) strictly limits the price Medicare will pay for “injectable” generic drugs. Prices for these drugs can still rise, but only by 6% or less, and only once every six months.  Congress (in its great wisdom and expertise in matters economic) made the judgment that this kind of price rise would be sufficient to balance market forces. But Congress was wrong.

This law took effect January 1, 2005.

The margins companies get for generic drugs are already low. And the cost of making (and managing the distribution of) sterile, injectable drugs is inherently higher than for most generic drugs. So the profit margins for these drugs, already low, was severely challenged by these new price controls.

The industry reacted quite rationally and predictably to this new law.  The big companies, which could maximize their profits by devoting their manufacturing space to other products, got out. And new, generic drug companies got in. These generic drug companies do not have to bear the cost of research and development, so their overall cost of production is substantially lower than for the big companies – their business models indicated they could pull a reasonable profit even with the price controls, if all went well. But to do so, they had to employ cheaper manufacturing processes, with less quality control and less production redundancy. So, quite predictably, there were quality issues, and when these issues occurred there was no redundant production capacity available to pick up the slack. And stringent new FDA standards meant that each time such an issue occurred, their production would be off-line for months, or even a year or longer.

But for DrRich to belabor the story from this point would only be to elaborate on the multitude of proximate causes for the drug shortages, all of which are merely artifacts of the ways the industry chose to respond to the root cause – i.e., to government-imposed price controls.

The President’s executive order ostensibly aimed at fixing the drug shortages will of course be ineffectual. While it implies new regulatory zeal which will further increase the cost of production and worsen the cost/price mismatch, it does not acknowledge let alone address the root cause.

In this light, the President’s attitude toward the grey market that has sprung up in response to the drug shortages is particularly instructive.  A grey market, as DrRich understands it, is like a black market but less illegal.  And we know a lot about black markets.

A black market acts outside the legal economy to provide customers with products they cannot get within the legal economy. The price a black market dealer gets for the product simply reflects current market forces, given the product shortages which exist within the legal economy, the risk the black marketeer takes in providing the product extra-legally, the additional “security” they require, &c.  So the customer pays through the nose, but at least he can get the product he wants or needs.

The very presence of grey/black markets generally indicates that the shortages which are present within the legal economy are not inherent but artificial – that is, the products are demonstrably available, for the right price. That product’s abundance would increase and the price would adjust to some more reasonable value if only the customer were permitted to pay what the market will bear. (The true free-market price for any black market product will always be far higher than the legal economy allows, but far lower than the black market demands.)

Fulminating about the greed of the grey marketeers does not hide this truth.

No wonder the President’s new decree attempts to convert the grey market for sterile injectables into a true black market, and in this way aims to snuff out this extremely embarrassing, all-too revealing, spectacle.

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In the speech President Obama gave responding to Congressman Ryan’s budget plan (the one in which he lured Ryan to sit in the front row in order to be publicly pilloried), the President did something DrRich did not think he would do before the next election. He openly invoked, and openly embraced, the Independent Payment Advisory Board (IPAB) as the chief mechanism by which Obamacare will control the cost of American healthcare.

“IPAB” might be a new term to many Americans, but DrRich pointed his readers to this entity, within a few weeks of the passage of Obamacare, as the lynchpin (and a very scary lynchpin at that) of the whole enterprise.

Until President Obama’s recent “outing” of IPAB, however, this new board has been almost entirely ignored by most commentators. Since the President’s speech, of course, many have written about it, either to celebrate it or to castigate it. (Of all these commentaries, DrRich most highly recommends the analysis provided by Doug Perednia at the Road to Hellth. In fact, DrRich recommends Perednia in general, as he is regularly producing some of the most insightful commentary, anywhere, on health policy.)

DrRich does not wish to simply repeat here all the observations that have lately been made by others regarding the IPAB. Rather, he will emphasize three particular features of the IPAB, features which are remarkable indeed, and which will tell us something very important about our Progressive leaders.

Three Remarkable Features of the IPAB

1) It has dictatorial powers.

The IPAB is a 15-member board appointed by the President.  Section 3403 of the Obamacare legislation tells us that the purpose of this board is to “reduce the per capita rate of growth in Medicare spending,” a noble goal indeed. Furthermore, in a superficial reading of Section 3403, one might think of the IPAB as a sort of Mr. Rogers of healthcare – a mild-mannered, friendly, always-helpful, but ultimately undemanding agent for good. This is the impression imparted by the first few paragraphs of the Section, which paint the new entity as an “advisory” board, whose main task is to develop “proposals” and “advisory reports,” which “proposals” and “advisory reports” would solely consist of various “recommendations,” that ought to be “considered” for the purpose of cost reduction.

Indeed, one might get the impression that the main difference between the IPAB and DrRich (another Mr. Rogers-like, mild mannered and undemanding personage) is that the former is appointed by the President and has a travel budget.

Nothing could be further from the truth. The IPAB is actually all-powerful.

Once the Chief Actuary of CMS determines that the projected per capita growth rate for Medicare exceeds a certain target growth rate (which it inevitably will), the IPAB is required to submit a so-called “proposal” which will cut healthcare costs sufficiently to bring the growth rate back in line; which is to say, the IPAB will determine what will be paid for and what will not. Then, the Secretary of HHS is required to implement that “proposal” in its entirety, unless Congress acts to block implementation. However, Congress is hamstrung.  The representatives of the people are forbidden from taking any action “that would repeal or otherwise change the recommendations of the Board,” unless it replaces those “recommendations” with its own legislation that would cut healthcare spending to the same target level.

For all practical purposes, then, the cost-cutting “recommendations” which the IPAB would “propose” for “consideration” will be implemented nearly automatically, with the full authority of the Federal government.

And, for all practical purposes, the IPAB will become a new agency of the executive branch, with near-dictatorial authority to cut healthcare spending where and when and for whom it sees fit.

2) It will control all healthcare spending, not just Medicare spending.

A common accusation, heard these past few weeks from conservative commentators, is that the secret desire of the President and his supporters is to make it so that the IPAB will have these same dictatorial powers over not just Medicare, but over all healthcare spending – public or private. DrRich believes these conservative commentators are unnecessarily accusing the President of being conspiratorial. In truth, no conspiracy is necessary, as this result is already law.

DrRich recommends that these conspiracy theorists read the actual legislation. It is a bit difficult to sort out, but in fact the IPAB is already granted the authority to control private as well as public healthcare spending.  It got this authority in a suitably convoluted way.

Those who paid attention to the remarkable process that brought us our new and transformational healthcare system might recall that the Senate bill, which ultimately became law of the land, was never designed to be actually implemented. It was designed solely to assure 60 votes in the Senate, after which the Joint Conference with the House was to meld the House Bill and the Senate Bill into a workable law.

As part of the negotiations to gain those original 60 votes in the Senate, five or six Democrat Senators went behind closed doors to cobble together a list of amendments to the original Senate Bill – the so-called Manager’s Amendments. It is in the Manager’s Amendments that one can find such famous niceties as the bribes paid to Nebraska in order to obtain an extra vote. But the Manager’s Amendments (which, contrary to the expectations of the actual Managers, are now part of our new healthcare law) contained lots of other stuff as well.

One of the more interesting parts of the Manager’s Amendments (Section 10320) is entitled, “Expansion Of The Scope Of, And Additional Improvements To, The Independent Medicare Advisory Board.” (The original language in Section 3403 did not actually create something called an IPAB – it created an IMAB. The Manager’s Amendments re-christened it as the IPAB, as explained below.)

Section 10320 (which can be found way down on page 2210 of the new law) grants the IPAB (beginning in 2015) the authority to limit all healthcare expenditures, that is, all healthcare expenditures, and not just expenditures by Medicare or government-run programs.

To emphasize this expanded authority, Section 10320 changes the name of the “Independent Medicare Advisory Board” (created in Section 3403) to the “Independent Payment Advisory Board.” It directs the IPAB, at least every two years, to “submit to Congress and the President recommendations to slow the growth in national health expenditures” for private (non-Federal) healthcare programs. Furthermore, it designates that these “recommendations” may be implemented by the Secretary of HHS or other Federal agencies “administratively” (that is, without the interference of Congress).

The justification for this expansion of the IPAB’s authority is that controlling private healthcare expenditures will directly impact Medicare, since the “target” Medicare growth rate which the IPAB is charged with achieving will be determined by overall healthcare expenditures. Therefore, it is necessary to control those private expenditures. More practically, if Medicare patients (who are subjected to arbitrary cost-cutting measures) see their younger counterparts enjoying less restricted healthcare, we old farts are likely to become inconveniently rowdy.

Once the Managers had devised enough paybacks in the Managers’ Amendments to get the needed 60 votes, and the law finally passed in the Senate, President Obama and his Congressional allies, Mr. Reid and Ms. Pelosi, determined that allowing the new law to go to Joint Conference would be counterproductive (in particular, they would undoubtedly have lost Section 10302 if the House Democrats ever saw it). So the entire Congress was coerced into voting on the bill as passed by the Senate – including all the Managers’ Amendments – under the reasoning that passing the law right then was a manifest emergency.  And Congress, like the rest of us, could find out what was in it after it became law.

We are likely to hear grumbling from even some House Democrats as the real implications of the IPAB become more apparent to the public, since the House Democrats really didn’t get an opportunity to vote on (or read) this provision, except as part of an “all or nothing” healthcare reform bill.

Whatever. While the IPAB may begin by only controlling the cost of Medicare, it already has the authority to control all healthcare spending, including private spending. That’s you, dear reader. No further legislative action is needed.

3) It is an immutable entity.

Section 3403, the section that creates the IPAB and spells out its functions, contains some remarkable language that, DrRich suspects, has never been seen before in American legislative history. To wit:

“It shall not be in order in the Senate or the House of Representatives to consider any bill, resolution, amendment, or conference report that would repeal or otherwise change this subsection.”

So, the astounding truth, dear reader, is that the IPAB and all its designated dictatorial functions are in force for perpetuity. Our Congress has passed legislation that purports to bind all future Congresses from altering it in any way.

We can surmise from this fact that those who wrote this law must consider the IPAB to be very, very important. Of course, we know this because President Obama said so just the other week. However, what many Americans may not yet realize is that the IPAB provision of Obamacare must necessarily be not only the most important feature of our new healthcare system, but also the most important legislative provision ever written. We know this because no other provision has ever received such extraordinary protections from any future alterations whatsoever.

DrRich asks his readers to bask in the utter audacity of our current crop of leaders, leaders who are so sure they know what’s best for us that they were willing to engage in all manner of legislative legerdemain to pass Obamacare, not only against the apparent expressed will of the people, but also (as it turns out) against the objections any future American Congress may have that is sent to Washington by those people.

Not even our Constitution itself – a document that attempted to establish a government for all time – was as audacious as this. For the Constitution, at least, provided a mechanism for its own alteration.

As DrRich racked his brain to think of the last time a law was promulgated with such audacity – not with the audacity of hope, but the audacity of perpetuity – he initially drew a blank. Even monarchs who purported to reign under Divine Right understood that future monarchs, who would also rule under the same God-given right, might thus alter any laws they made.

DrRich believes we need to go all the way back to Moses, coming down from Mt. Sinai and holding aloft his awesome Tablets filled with divine writ, to find a law or set of laws that, from the moment they were written, were decreed to remain in force for ever and ever.

Only God has ever tried this before.

What Does This Tell Us About Progressives?

DrRich has gone on at some length about the Progressive program and the Progressive mindset. The creation of the IPAB, its configuration, and the manner in which it was created, simply reflects that program and that mindset.

Progressives are dedicated to “progressing” to a perfect society, and they know just how to achieve it. Unfortunately, a whole bunch of people – not merely right-wingers and a few Republicans, but most of the masses – just don’t see it their way. Specifically, the Progressive program requires individuals to subsume their own individual interests to the overriding interests of the collective – and human nature just doesn’t function that way.

Thus, the Progressive program inevitably relies on a cadre of elites – those who have dedicated themselves to furthering the Progressive program – to set things up the right way for the rest of us, while manipulating we in the teeming masses to let them. And the rest of us, once the correct programs and systems are in place, will at last understand that it was all for our own good. (Those of us who still don’t get it, to extrapolate from the actions of various collectivist governments of the past century, will either have to be re-educated or eliminated.)

The IPAB would serve as an ideal poster child for the Progressive program. It is an all-powerful commission of experts, appointed by Progressive leaders, which will make decisions based on only the “best” available data (and they are the determinants of what is “best”), that deeply affects the lives of every individual American, whatever the decisions might be that individuals would have made for themselves.

The manner in which the IPAB was created is a model for the Progressives. It involved manipulating the body of government that the Progressives find most problematic – the Congress, the voice of the people – and entirely marginalizing it.

The immutability of the IPAB is also a Progressive dream. Congress was manipulated into creating an all-powerful entity which it (the voice of the people) is enjoined from ever altering, down into perpetuity.  The IPAB is forever within the control of the executive branch, which the Progressives, of course, intend to hang on to at all costs.  (And, if lost, is relatively easy to regain.)

The fact that President Obama has at last brought the IPAB out of the closet, and has deemed it to be ready for public scrutiny, indicates that he is confident that the people will not understand the profound nature of what has been accomplished by the establishment of such an entity, or if they understand, will still be indifferent about it.

DrRich dearly hopes the President is wrong about this.

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A well-known Progressive blogger has taken issue with this post – and with DrRich.  See DrRich’s reply to said well-known blogger, here.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Podcast:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

CMS knows exactly what it’s doing here.

Podcast:

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This is the second in a series of articles on End-of-Life Care and Covert Rationing.  The first article can be found here.

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In the summer of 2008, the Oregon Health Plan (the Medicaid plan in Oregon) injudiciously sent a letter to lung-cancer patient Barbara Wagner denying coverage for the expensive chemotherapy her doctor had recommended, and offering instead to cover palliative care “including doctor-assisted suicide.”

Despite the fact that there were plenty of distractions at the time (including a presidential election and the world’s economy on the brink of Armageddon), that letter unleashed a firestorm of public outrage. (If you have forgotten the outrage, simply Google the search terms “Barbara Wagner” and “suicide.”) Indeed, the outrage was sufficient to penetrate even the dulled sensibilities of the Oregon Health Plan’s executives. One Jim Sellers, a spokesman for the Oregon Health Plan, admitted to ABC News that “the letter to Wagner was a public relations blunder and something the state is ‘working on.’”

It is clear that the Oregon Health Plan executives were at least a little blindsided by the general reaction to their ham-handed denial letter. Denial letters, after all, are a routine activity, and they always list (as an aid to the patient) services which the third party payer judges to be reasonable alternatives to the denied care. While in this case the denied service which Ms. Wagner sought offered some reasonable hope for prolonged survival, and the service being held out by the Oregon Health Plan as an alternative (to say the least) did not, that’s really not so much different from the content of more “routine” denial letters. The difference is one of degree, and not of substance. So, Oregon Health Plan executives must surely have wondered, “What’s the big deal?”

One must try to be understanding of such insensitivity. It is a fundamental task of health plans – whether run by Medicare, Medicaid, or private insurance companies – to deliver unpleasant news to people whose lives are at stake, and it is normal (even necessary) for those who are charged with this task either to grow thick skin or to develop the traditional indifference of bureaucrats. It is perfectly predictable that such thick skin or indifference might dull one’s ability to discern subtle differences in degree among various denials of services, subtle differences that might call for more artful phraseologies than those employed in this instance by the Oregon Health Plan. The failure to recognize the need for a more artful denial letter, Mr. Sellers appeared to say, was the only problem in the case of Ms. Wagner. The solution, he therefore suggested, is certainly not a substantive change in any policy, but better public relations.

Those who ran the Oregon Health Plan must have been particularly disheartened to learn that even vocal proponents of physician-assisted suicide immediately began criticizing their ill-considered denial letter. To so blatantly juxtapose the reality of healthcare rationing with the “option” of assisted suicide seriously undermines the chief argument advanced publicly by the end-of-life movement, namely, that assisted suicide is merely an individual autonomy play, and is not in any way a cost-saving tool.*

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*Preserving the ethical precept of individual autonomy is the basis upon which modern utilitarian ethicists always build their defense of doctors ending the lives of their patients, whether it be by physician-assisted suicide, passive euthanasia, active euthanasia, and even involuntary active euthanasia. DrRich will elaborate on this ethical defense in a future posting.
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In other words, whether or not you embrace physician-assisted suicide, everyone seems to agree that offering it up as a covered medical service at the same time you are denying potentially life-prolonging therapy is both insensitive and unseemly.

And so – as a public service to those in the government and the private sector alike who are running healthcare organizations and thus who are (as a matter of course) severely challenged in trying to understand simple human emotions, to patients like Ms. Wagner who may suffer true physical harm by exposure to such institutional callousness, and to the rest of us who simply would appreciate not being confronted so blatantly by the dark abyss that underlies our healthcare system – DrRich offers the Central Authority and private insurers some friendly advice on the right way to sell physician-assisted suicide.

1) Don’t Seem So Anxious.

Sure it’s easy to get excited about physician-assisted suicide. All you need to do is look at your own data. Whether you are trying to make ends meet over at CMS, or running a private health plan, it’s likely that a huge proportion of your spending goes to patients who are in the last year of life. Enticing these end-of-lifers to choose assisted suicide (which you can accomplish in a sufficiently tasteful way for about $100) is such an attractive proposition that it’s indeed become very hard to make yourself appear reasonably circumspect about it. At the very least, if you run an organization like the Oregon Health Plan, where assisted suicide is “available” at no additional cost to patients who choose it, it’s difficult not to push the idea when the opportunity arises. Otherwise how can you be sure the patients will know all their options for end-of-life care?

But doing even that much is a mistake. If you don’t believe that, simply look at the small firestorm the Oregon Health Plan created with their straightforward and helpful “reminder” letter to Ms. Wagner. As a result of the Oregon Health Plan’s inept attempt at informing patients of their options, neighboring states that appeared ready to pass their own assisted-suicide laws immediately had second thoughts about it. It should now be clear even to health plan bureaucrats that seeming overly interested in assisted suicide, or even mentioning the option to patients (at least while simultaneously denying potentially lifesaving therapy) is a very counterproductive idea.

A much more subtle approach is required.

2) Publicly Disavow Any Interest In Assisted Suicide.

Think about Tom Sawyer whitewashing the picket fence. Ole Tom didn’t get all his friends to paint that fence for him by asking for their help, or by overtly trying to sell or cajole them on the idea. Instead, he got them to do the job by pretending he wasn’t the least bit interested in having them do it, by ignoring them altogether, and making himself seem completely absorbed in the delightful task. By the time Tom was done, his friends were begging for a turn, and even giving him wondrous gifts (such as dead cats on a string) to bribe him for a chance to participate.

What you need to do is pretend that encouraging assisted suicide – even if it’s a covered service that patients ought to be made aware of – is the farthest thing from your mind. Instead, you are completely invested in and insistent upon providing full-service end-of-life care, with all the bells and whistles and no holds barred; and – while patients of course have the option to exercise their individual autonomy as they see fit – you take great pride in squeezing every last instant of life out of those elderly, used-up, chronically ill bodies that present themselves in your ICU, no matter what the cost to the patient and family in terms of pain, suffering, humiliation and anguish. It is your mission to stave off death to the bitter end, come what may, and you’re proud of it.

3) Have Somebody Else Push It.

In the meantime, clear the path for agencies and interest groups which are dedicated to the end-of-life movement. There are plenty of them out there. Have them do the selling for you.

Make sure they have access to your patients and patients’ families, especially in the ICU setting. Allow them space for educational displays; provide them some private space where they can talk to interested patients and families; see that hospital social workers are aware of and will enable their activities. In the meantime, make it clear that you do not endorse or encourage their efforts, and indeed wish they would go away, but you are providing such groups with access in your dedicated interest of full transparency, and your commitment to patient choice. If patients choose to avail themselves of such information, you will do nothing to stop them.

4) Make the Advantages To Assisted Suicide Seem Real.

There’s no need for you to talk up the advantages of assisted suicide – let the end-of-life proselytizers do the talking for you. All you have to do is to make their arguments seem accurate. The great part is, that’s just a matter of maintaining business as usual.

The end-of-life zealots will tell patients that assisted suicide is a way of asserting some measure of control over the dying process, of holding on to some level of personal dignity at the very end. So simply make sure your end-of-life care continues robbing patients of any semblance of dignity and control.

They’ll tell patients that assisted suicide will end pain and discomfort and suffering when all hope of recovery is gone. So simply continue with inadequate pain control** and half-hearted comfort measures, and keep the ICU as hectic, loud, scary and impersonal as possible.

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**Maintaining inadequate pain control will continue as a matter of course as long as the Central Authority continues sending the DOJ after the occasional pain-management doctor. Whether the target physician is actually engaging in analgesic excesses is unimportant to the goal of making any American doctor afraid of aggressively controlling their patients’ pain, for fear of becoming a target themselves.
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The end-of-life proponents will tell the patients themselves that assisted suicide will finally bring comfort to their long-suffering family and friends, whose lives have been “so disrupted by your prolonged illness.” And make sure all those family and friends continue suffering long, by keeping those ICU waiting rooms hot, cramped, noisy, uncomfortable and smelly.

You get the idea. Simply make sure the arguments of the end-of-life proponents have teeth. You’re good at that.

5) Tell Patients to Consult With Their Doctors First.

That’s right. Refer patients to their doctors, their supposed personal advocates, the selfsame individuals you yourself have long since fatally compromised (by grabbing control of their individual professional viability). Assuming you have placed sufficient cost-cutting pressures on doctors, then their willingness to encourage (or at least not discourage) assisted suicide will be substantial. So when patients do consult with their doctors, the doctors will not undermine your subtle efforts, but will become your partners in convincing those approaching end-of-life to just be reasonable.

6) Make Physician-Assisted Suicide Legal, But Not Reimbursable.

You’re going for the Botox model here. You do not want physician-assisted suicide to be merely another hush-hush medical procedure, conducted quietly and almost secretly in a typical doctor’s office, so that people can pretend it doesn’t exist. Rather, you want to establish it as something that’s front and center, something people will want and ask for and go out of their way to seek. You want to encourage doctors to establish inventive business models for assisted suicide,  just as the dermatologists have done with their Botox clinics.

Accomplishing this, of course, will require assisted suicide to be made legal everywhere (and not just in Oregon and a few other progressive states), but at the same time will require you to NOT make it a reimbursable medical service. For once it’s made reimbursable it will become subject to typical Medicare price controls, which thus will keep prices high and limit innovation. And in this once instance, you will not want to limit innovation.

Just think of the possibilities: One envisions physician-assisted suicide becoming established as a “life cycle event” like a wedding or Bar Mitzvah, where the right atmosphere, the right spirituality, and the right tone come together to create an unforgettable, uplifting experience for everyone. Some assisted suicides will take place in a doctor’s office, of course, but why not in a place of worship, a favorite city, a resort, a mountain top, a rocky coast – a casino? Why not allow the prospective decedent to actually hear the eulogies and experience the tearful tributes before actually engaging (ritually) in the Act? Why not partner with the new deathcare industry you will be unleashing (talk about job creation!) to wrap this final “healthcare service” into a comprehensive package along with funeral services, grave sites and headstones, elaborate obituaries, and full coverage on Facebook, Twitter, and UTube?  Why not engage American media to celebrate the event with a new mode of reality programming (one that is sure to garner a massive share of viewers)? Why not, at last, GUARANTEE every American their 15 minutes of fame (even if it’s their last 15 minutes)? Why not convert what is today an antiseptic, impersonal and frightening process into one that makes everybody say, “Yes! That’s the only way to go!”

The beauty is that this sort of model will convert what is today, at best, merely the option for assisted suicide into something that’s expected – a true destination event, a natural part of life. Indeed, not opting for assisted suicide, at a certain point in one’s life, will come to be seen as unusual, unreasonable, greedy and selfish. And when granny begins to spend more time in a doctor’s office or (worse) in a hospital, where frequent visitation is expected and other family inconveniences are generated, some loving grandchild will pat her precious wrinkled hand, and say, “Granny, you know, it’s getting to be about that time. Wouldn’t a last weekend in Vegas be just the thing?”

So, if you play your cards right – passively encouraging the end-of-life movement in its effort to spread the word, while making the alternative (i.e., not committing suicide) as nasty and foul an option as possible, and also while coercing doctors and encouraging families to view assisted suicide as the most advantageous modus exodus one could ever imagine – well, the “right” to assisted suicide will shortly become the expectation and even the duty for assisted suicide.

If you who run government or private health plans will just follow DrRich’s simple program, you will have accomplished all this without seeming crass and self-serving, as you most certainly do each time you send somebody a letter like the one you sent the unfortunate Ms. Wagner.

Podcast:

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This is the first in a series of articles on End-of-Life Care and Covert Rationing.  The second article can be found here.

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It is easy to have missed it, because it went by so quickly.

On January 1, the White House announced a new policy that would have paid doctors for discussing end-of-life planning during their Medicare patients’ annual “wellness visit.” Under this policy, physicians would be paid to encourage their patients to establish an advance directive, which would guide medical care if the patient became incapacitated from illness, and could no longer make medical decisions for him/herself.

But on January 5, the new policy was suddenly revoked. It was revoked, CMS lamely explained, because it had not been implemented using the correct process. But, as anyone would know who watched Congress make Obamacare the law of the land, this could not possibly have been the real reason.

The real reason, of course, has to do with the firestorm this new policy threatened to unleash, just as the House of Representatives was about to be taken over by the cretinous opposition party.

As regular readers will recall, the Obamacare bill originally included similar language on advance directives. Physicians were supposed to urge their patients, repeatedly if necessary, to establish advance directives, and their success in extracting advance directives from their patients was to be one of the “performance measures” by which doctors would be judged to be in good or bad standing with the Central Authority.

But then Sarah Palin said “death panels,” and a furor ensued. The provision on advance directives was quickly removed from the Obamacare legislation, as if Congress was admitting that Ms. Palin had been correct and they had been caught out.* Similarly, the effort last month to reinstate the provision failed to stick for fear of criticism at a bad time.

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*The original advance directive provision in Obamacare, of course, had nothing whatsoever to do with “death panels,” since there are no panels of any sort involved in establishing advance directives. Rather, the entities that some might call death panels, and which DrRich has chosen to call GOD panels (Government Operatives Deliberating) – that is, panels of distinguished experts that will determine, by means of “guidelines,” which patients will get what, when and how – remain fully operative within Obamacare.
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DrRich has nothing against advance directives, and indeed, thinks they are a good idea – in concept, at least. Advance directives allow patients to establish beforehand, usually by a written document, what kinds of medical treatment they would or would not want should they fall victim to a serious, life-threatening illness that leaves them unable to express their wishes. Advance directives are supposed to work by providing guidance to their physicians, who, in their fiduciary capacity, are charged with acting in the patient’s best interest.

A well-constructed advance directive allows patients to choose to spare themselves from demeaning, undignified, painful or otherwise undesirable medical procedures and treatments, should they become incapacitated at a later date. “Well-constructed” implies that the advance directives are clearly and concisely written, that they honor the ethical and legal norms approved by society, and that they provide the physician with clear guidance.

But it is more difficult to write a “well-constructed” advance directive than might at first meet the eye. The major problems are two-fold: Advance directives often express imperfect knowledge, and they are often imperfectly expressed. These limitations mean that in appropriately exercising an advance directive, often the physician cannot follow them to the letter, but must interpret them according to the circumstances at hand.

A healthy and relatively robust individual cannot always know how he or she will feel years into the future, when illness strikes and it is time to exercise an advance directive. Every doctor has seen critically ill patients who, despite having advance directives to the contrary, unhesitatingly choose to be attached to a ventilator when the time comes, for instance, rather than face certain imminent death. So experienced doctors know that advance directives do not always indicate what patients will actually choose to do when the time to make a choice is upon them.

They also know that, while conscious patients have the opportunity to repeal their advance directives, unconscious or incapacitated patients do not.** So, in exercising an advance directive, the conscientious physician interprets that directive in light of many other factors, such as, her personal knowledge of the patient, the opinions of family as to what the patient would want done, and the chances of a long-term recovery if the therapy being considered is used. Then she will negotiate with responsible family members an approach that appears to meet the patient’s presumed desires.

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**Conscious patients can repeal their advance directives in theory. DrRich has witnessed actual doctors, however, arguing vociferously against using a medical therapy that a sick patient now desperately wants, because years ago the patient signed an advance directive expressing aversion to that therapy.
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Therefore the advance directive in many cases is an important part of the decision-making process, but it is not the only part. The appropriate use of an advance directive requires the doctor to behave as a true patient advocate, to selflessly place the desires expressed in the directive in context with everything else that might affect the patient’s true and current wishes, and then make a recommendation that, to the best of his or her ability, honors those wishes.

Unfortunately, doctors can no longer act primarily as their individual patient’s advocate. Indeed, physicians are officially enjoined (by the New Ethics formally adopted by their own professional organizations) to give the needs of society at least equal consideration. And so, as has demonstrably happened with other “guidelines” in medicine, it is inevitable that advance directives will be reduced to a legal edict, which must be followed to the letter if the physician wishes to remain clear of the Department of Justice.

The likelihood that there will be no room for interpretation means that constructing just the right kind of advance directive for yourself – one that will be precisely suitable to any contingency that may occur – has become extremely difficult. If you get the details just a little bit wrong for the circumstances that actually arise, the price you pay may be very heavy. It would be better to have no advance directive at all than to have one that is misleading or ambiguous. Advance directives must be written with extreme care, and only after long, thoughtful consideration.

That is not how the government would have it, however. For many years now, the Feds, under the Patient Self-Determination Act, requires hospitals to inform patients about advance directives at the time of every hospital admission, and to invite them to sign one. To say this is a less than ideal time to implement an advance directive would be something of an understatement. Asking a patient to sign an advance directive at the time of hospital admission, often by including it in the pile of routine and mind-numbing legalistic documents which patients must sign if they want to receive medical care, and often with no more guidance than that provided by the admissions clerk (who might explain, “This tells the doctors you don’t want to be kept alive on a machine like a vegetable,”) tells us something about whether the true motive for advance directives is to protect the patient’s autonomy – or to reduce costs.

Having the discussion in a doctor’s office these days, sadly, might not be much better. The Central Authority knows that squeezing what really ought to be at least a 30-minute discussion into a 10-15 minute office visit already packed with Pay for Performance requirements (while providing the added threat of punishment if the physician fails to extract an advance directive from the patient), will yield, at best, a signature on a boiler-plate document.

But despite the slap-dash method by which such a document may be implemented, it is a document whose language – when the time comes – will be exercised with all the legalistic exactitude of a contract attorney by any doctor who knows what’s good for him.

DrRich thinks that Americans are right in being suspicious of the big push they are seeing to urge advance directives upon them. Invoking “death panels” in this regard is utterly inappropriate, but the end result will suffice. It is good that we have all been given pause.

Still, the concept of advance directives is a good one, and DrRich thinks most Americans might do well to have one. Despite the damage that is being done to them, DrRich thinks advance directives can be salvaged. To this end, DrRich suggests several steps we can all take in executing an advance directive that will actually do what we want it to do:

1) Don’t be pressured into implementing an advance directive by anybody whose career depends on keeping the Central Authority happy. Unfortunately, this likely includes your doctor if you are not paying your doctor yourself.

2) Don’t sign a boiler-plate document. These likely will have been drafted with the interests of the Central Authority in mind, with the help of very smart lawyers, and when these documents are called into use in all probability they will be interpreted for the convenience of the Central Authority.

3) Try to keep your advance directive from showing up in an electronic medical record. Write it yourself, and store it where your loved ones can find it when they need it. Give a copy to your spouse, your children, and perhaps (if you have a direct-pay doctor who works only for you) your physician. This way, since your advance directive will not be immediately available to hospital personnel if you are suddenly incapacitated, no unfortunate and irreversible decisions regarding the aggressiveness of your medical care can be made until your loved ones are notified.

4) Write your advance directive as a general guideline, with as few specifics regarding particular types of medical care as possible. You should assume that any type of treatment you mention in a negative light will be withheld under any and all circumstances, including circumstances you may not be aware of in which you would want that treatment.

5) You are not writing your advance directive for the doctors (it is most tragic that we can no longer trust doctors in this regard!); you are writing it to help your loved ones make the right decisions for you, perhaps despite the doctors. So your goal should be to clarify your general desires for your loved ones. Discuss your advance directive with your loved ones after you have written it, and ideally, before you have written it. Your written words will remind them of your wishes when the time is right.

Lest you think, Dear Reader, that  DrRich is merely being sarcastic  here (and why would anyone think so?), he is not. DrRich himself has an advanced directive that attempts to follow these rules. The document is stored at home with his important papers. Mrs. DrRich knows where to find it, and knows DrRich’s general feelings regarding these matters. With the guidance he has provided, DrRich trusts her and his children to make these important decisions for him. For anyone who is interested, DrRich’s advance directive is reproduced, in its entirety, at the end of this post. (The general language, which has been adapted and revised by DrRich for his own use, was originally suggested to him by a good friend who is a superb internal medicine practitioner.)

So. Advance directives are a very good idea, but unfortunately, have been identified by the Central Authority as a potentially powerful cost-cutting tool. Even before Obamacare, certain HMOs were refusing to reimburse hospitals or doctors that provided medical care that seemed to go against specific language contained in an advance directive. That, of course, was child’s play. Now that the Central Authority has gotten hold of them, advance directives will likely be treated the same way as other guidelines are now treated in medicine, that is, as edicts, and thus as vehicles for the criminal prosecution of medical personnel who deign to “interpret” them.

This means that if you wish to take advantage of the benefits which advance directives can provide, you will have to proceed very, very carefully.

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DrRich’s Advance Directive:

If I am able to communicate my wishes by any means whatsoever, then I wish to make my own decisions regarding my own healthcare. If, despite my ability to communicate, my condition makes it inconvenient to fully inform me of my situation and all my treatment options, then until such time as it becomes sufficiently convenient to do so, I want everything possible to be done to sustain my life and effect a recovery.

In the event of an incapacitating illness in which I cannot communicate, the basic guideline initially should be to do everything possible to sustain my life and effect a recovery.

After a reasonable period of time (in general, I would consider a week to be reasonable) if no progress has been made in the recovery of my mental function, and the likelihood of mental recovery is judged to be small, then withdrawal of life-sustaining care should be strongly considered. To help my wife and/or children with this decision, I would like to have an evaluation by a neurologist to help clarify the prognosis.

If improvement in my mental status has been made, then efforts to sustain my life and affect a recovery should be continued.

If at any point in my care there is a period of at least two weeks in which I am persistently unable to carry out meaningful communications sufficient to make my own wishes known (in the opinion of my family members and the neurologist), and the likelihood of mental recovery is judged to be small, then I would consider the withdrawal of life-sustaining care to be a blessing.

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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.

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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.

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In his last post (and in several past discussions) DrRich asserted that the Hippocratic Oath has been declared formally and officially obsolete by the medical profession itself, and that as a result of this action, the medical profession has voluntarily placed the professional viability of all physicians entirely into the hands of the government. Hence, DrRich has postulated, the Amish Bus Driver Rule is thereby activated, which permits (and probably compels) the government to use the leverage of medical licensure to control and direct the behavior of physicians – even their ethical behavior.

Lest anyone think DrRich is exaggerating about this, let us listen to the words of some of the physician-intellectuals who now hold positions of official responsibility, within the Central Authority itself, for determining the behavior of American doctors. DrRich asks his readers to notice both the content and the tone of these words, as both are important.

First, listen carefully to Donald Berwick, MD, recent recess-appointee to the position of head of CMS, in a passage from his ominously-titled book “New Rules,” (co-written with our old friend Troyen Brennan, MD):

“Today, this isolated relationship [between doctor and patient] is no longer tenable or possible… Traditional medical ethics, based on the doctor-patient dyad must be reformulated to fit the new mold of the delivery of health care…Regulation must evolve. Regulating for improved medical care involves designing appropriate rules with authority…Health care is being rationalized through critical pathways and guidelines. The primary function of regulation in health care, especially as it affects the quality of medical care, is to constrain decentralized individualized decision making.”

(Thanks to Dr. Gaulte of the excellent blog, Retired Doc’s Thoughts, for pointing us to this valuable passage.)

Dr. Berwick’s views on the need to constrain individualized decision-making in the practice of medicine is echoed by none other than Ezekiel Emanuel, MD, PhD. Dr. Emanuel is a bioethicist at the National Institutes of Health, and a fellow at The Hastings Center (a bioethics research institution). He is the brother of former White House Chief of Staff Rahm Emanuel (himself an expert in political ethics). Dr. Emanuel was brought in to the Obama administration as a high-ranking adviser on healthcare reform, and is widely expected to have a strong hand in determining who will sit on the GOD panels and how those panels will operate.

Regular readers will recall that Dr. Emanuel is also the co-author of that infamous paper recently accepted for publication in the Annals of Internal Medicine (and whose editors, thereby, formally auditioned for seats on those GOD panels) which called upon American physicians to abandon their ancient tradition of primarily serving their patients, and instead embrace their true destiny, which is assimilating into the Borg.

DrRich has found two instances in Dr. Emanuel’s writings in which he specifically commented on the obsolescence of the Hippocratic Oath.

In the May 16, 2007 issue of the Journal of the American Medical Association, in an article entitled, “What Cannot Be Said on Television About Health Care,” Emanuel expresses the following complaint about American physicians: “Reasoning based on cost has been strenuously resisted; it violated the Hippocratic Oath, was associated with rationing, and derided as putting a price on life, akin to the economist who knew the price of everything but the value of nothing.”

In the June 18, 2008 issue of the same journal, in an article on healthcare “overutilization,” he discussed seven factors that drive the overuse of medical services. He identifies one of these factors as a “culture of unwarranted thoroughness” on the part of American doctors, which serves to drive up cost. “This culture is further reinforced by a unique understanding of professional obligations, specifically, the Hippocratic Oath’s admonition to ‘use my power to help the sick to the best of my ability and judgment’ as an imperative to do everything for the patient regardless of cost or effect on others.”

Thus, Emanuel finds that it is a stubborn adherence to outdated medical ethics, which causes doctors to strictly place their individual patient’s interests above society’s interests, that accounts for a substantial proportion of unnecessary healthcare costs.

These passages from the very physicians who are directly driving healthcare policy through the auspices not of professional medical organizations, but through the auspices of the Central Authority itself, are striking in two ways.

First, their directness is striking. Doctors no longer work for the good of their patients; they work for the good of the collective. And heretofore they are obligated to follow the rules which are promulgated centrally, rules backed by the righteous force of the Central Authority, rules whose primary function is to make sure that decisions on medical care will be directed centrally, rather than at the doctor-patient level.

Second, the indignation these passages reflect is striking. The obligation of physicians to follow central directives is not an item of negotiation or persuasion – it is a DONE DEAL. Physicians’ own elected leadership of their own professional organizations – all of them – have formally signed on to the New Ethics, ethics which obligate doctors to practice medicine in a way that follows the dictates of remote panels guarding the interests of the collective  (rather in a way that jealously guards the needs of individual patients). And while this abandonment of an ethical precept that had been in force for over two millennia was promulgated with little fanfare, and while most practicing physicians seem not to realize that it has even happened (though we can be sure that all medical students everywhere are being steeped in it), it is a DONE DEAL.

And doctors who persist in practicing the “old way,” are not only acting in a manner that is “no longer tenable or possible,” but they are also violating the very ethical precepts which their own profession has now voluntarily adopted. They are behaving unethically. They are being evil.

No wonder our physician leaders are indignant. No wonder they have little choice but to divine the necessary “rules with authority” to force these recalcitrant physicians to do their self-admitted duty to the collective. By persisting with their old fashioned ideas in the face of that which medical ethics now prescribes, doctors are forcing the Central Authority to take strong action. Fortunately, since (we all know) our government is a benign entity, it will begin gently, with tough central rules and regulations (backed by authority) to “constrain decentralized individualized decision making.” The Central Authority will only invoke the Amish Bus Driver Rule (or worse) if these kinder, gentler steps fail.

As for the doctors who do not like this new reality, DrRich has a harsh message. You brought this on yourselves, by allowing your professional organizations to propose, write, and adopt these “New Medical Ethics.” For all the statements of Berwick, and Emanuel, and other health policy experts, castigating you for your inadherence to these new ethics, are predicated on the fact that you have a formally-adopted obligation to follow them.

It does no good to protest that you yourself were unaware that your profession has taken this formal action. Just as President Obama is your President whether you voted for him or not, the New Ethics is your formal rule whether you agreed with it (or were aware of it) or not.

And if you do not like the idea that the details of your behavior as a practicing physician are going to be handed down from on-high, and that you are not to be permitted any longer to primarily advocate for your patient, against the competing interests of the slavering Central Authority, you have nobody to blame except yourself.

And what this tells us is that if you are going to change things, you cannot hope to seek relief from legislators, or from your medical leadership (which has already assimilated with the Borg). Your only hope is to begin by reclaiming your profession yourselves, and re-asserting your primary obligation to your patient. There are several ways to undertake such a course, all of which will require standing up to the government and to your own leadership, and all of which will be difficult and dangerous at this late stage.  But it is the only path that remains open to you for your professional salvation.

Just keep this undeniable fact in mind: Obamacare, or any other form of centralized control over the practice of medicine, can only be achieved with the active acquiescence of physicians themselves. If physicians decide they simply will not allow themselves to be coerced to unethical medical actions, and insist on reestablishing the doctor-patient covenant as the guiding precept of their profession, the entire house of cards will fall. Physicians are far from powerless, if they would only dare to act.

We will still need healthcare reform, to be sure, but physicians have the power to insist that it can only be a kind of healthcare reform which fully honors and guarantees that covenant.