How The Implantable Defibrillator Became An Abomination

DrRich | January 28th, 2011 - 10:52 am

Podcast:

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.

10 Responses to “How The Implantable Defibrillator Became An Abomination”

  1. Milan Seth says:

    I just discovered your blog and really enjoy it.
    What do you think of the Cameron Health leadless ICD – do you think this or similar products are likely to break the market failure situation you describe so well?

    I have to say I think your third point is a little cynical, it seems to me that the argument often made is that SCD spares some patients a truly awful death from CHF pump failure.

    • DrRich says:

      Milan,

      I think the concept of a leadless ICD is potentially very disruptive to the current ICD market, particularly to point 1. “Potentially” because it depends a lot on how the device is marketed, and on what stipulations the FDA ends up placing in its use.

      When I first started expressing point 3, about 15 years ago, it was largely in the way of satire. However, in observing the body of evidence that has accumulated during that interval, I have come to feel there is a lot more truth in this view than I ever would have believed possible.

      Rich

  2. Hugo Campos says:

    DrRich,

    The points you make here are hard to take. As a patient advocate and ICD recipient, my first reaction was a defensive one. Unfortunately, I must agree with you on the toxic symbiosis between doctors and industry and on government price controls.

    However, believing in lack of constituency for sudden death is too out there even for me. But if you’re right, it only points out the collective failure of health activists like myself, patient groups and many NPOs to effectively raise awareness of sudden cardiac arrest. I simply cannot imagine there’s a deliberate interest in allowing 300,000+ lives a year to be lost to sudden cardiac arrest in part because it makes economic sense.

    Furthermore, if the ICD has become an abomination, doctors and the CRM industry only have themselves to blame.

    The way out of this mess is to bring transparency to cardiac rhythm industry (and health care in general). It is also by educating and empowering patients to become true stakeholders every step of the way.

    Hugo Campos
    ICD User Group

    • DrRich says:

      Hugo,

      You said, “I simply cannot imagine there’s a deliberate interest in allowing 300,000+ lives a year to be lost to sudden cardiac arrest in part because it makes economic sense.”

      Fundamentally I agree with you here. There is no deliberate interest in doing so. Instead, the interest is subtle. It’s an alignment of incentives from top to bottom, without any individual or group in power making an overt policy decision on the matter. I am simply pointing out the final result of this alignment of interests, and interpreting what that alignment looks like from 10,000 feet.

      When the chief purpose of a healthcare system is to ration healthcare covertly, the rationing occurs not by overt policies made by some sinister board of death panelists, but by whatever means you can get away with. Establishing these “whatever means you can get away with” almost requires that certain segments of the medical community, or their activities, be demonized. Once demonized, everything they do can be interpreted, by the press, public and Central Authority, in the “proper” light, and any actions against them justified. Just so happens that those actions will curtail the expensive medical activity, however useful it may be to many patients.

      The CRM example is just one of many. It is the one that I am the most familiar with, and the most saddened by. Whoever is to “blame,” the industry and the doctors are probably beyond being able to act in a useful way to extricate themselves. As I see it, empowered patients are the only hope. But patients had better not wait for “empowerment.” They will have to go get it themselves.

      Best of luck in your endeavors to do so, and if I can help in any way just let me know. Having left practice more than 10 years ago, my chief encounters with the healthcare system in that interval, and into the future, have been and will be as a patient, or the loved one of a patient.

      Rich

  3. Amy Carroll says:

    I am only in my 30′s and I have one of these ICD’s. It is also one that is on high alert because of a faulty lead. I just want to say that the #1 last reason for this being an abomination sounds really cold hearted and cruel to someone. I am probably misunderstanding alot of this and I wished I understood it all. Thanks for the Pod cast. It gives us a good look at our how government stands on improving medical technology.

  4. cory says:

    Aside from in-hospital treatments, it would be great if there was some way that people could just get medical evaluations outside of the industry since there are apparently a lot of individuals out there who want people to go without health insurance by charging outrageous fees for care.

    It would be awesome if there was some kind of online application that people could use that offered free prognoses that were automatically generated online. People could just take an online quiz where they fill in certain information and an automated response detailing what medication or device works best to alleviate their pain or discomfort could pop up.

    There’s already a similar app: http://mindflashad.com/branding-concept-quiz/posts

    but it does free business branding concepts instead.

    That’s all most doctors or physicians do anyhow – is just look symptoms up in a book. So an automated online application could just do the work for them and save people the trip and money.

  5. drsergio says:

    The leadless ICD is potentially disruptive, but likely to be coopted by industry.

  6. [...] Rich of The Covert Rationing Blog explains how the implantable defibrillator became an abomination.  Dr Rich was one of the early pioneers who worked with implantable cardioverter defibrillators [...]

  7. TR says:

    $25000 for an electronic medical device is just too high. Certainly this device’s chips and wires don’t cost as much as a New Lexus and probably less then an iPad. Why do payers let such prices go unchallenged.

    • DrRich says:

      TR,

      Right you are. Indeed, I’d be willing to sell you all the components of an ICD for a few hundred dollars (some assembly required). Of course, there may be some incidental overhead costs you’ll also have to factor in when you decide how much you’ll need to charge your patients for it.

      As for the payers, if you’ll re-read my post you’ll see it’s they who are setting the price, and keeping it so high. Imposed price control measures always do that.

      And if you like your incredibly inexpensive and incredibly useful iPad, then thank God it’s not a regulated medical device. (I was about to say that if it was, it too would cost $25,000. But actually, if it was, it never would have been built in the first place.)

      Rich

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