Thursday, January 20, 2011

DOJ Investigating Defibrillator Implanters

From the Heart Rhythm Society member's website today:
"The Heart Rhythm Society (HRS) is aware of an ongoing U.S. Department of Justice (DOJ) civil investigation of Implantable Cardioverter Defibrillator (ICD) implants and has agreed to assist in an advisory role to lend expertise concerning proper guidelines for clinical decision making. As an advisor to this investigation, HRS is reviewing information that does not include either identifiable patient or facility level data. Rather, we are providing insight on the field of electrophysiology to the DOJ. Because this is an ongoing investigation, HRS Staff or Leadership is not available for further comment. HRS will communicate additional information to its membership when permitted to do so by the DOJ."
This action comes, no doubt, on the heels of the recent publication in JAMA which reviewed an ICD registry of implantation practices in America from 2006 to 2009 and found 22% of ICD implants were implanted outside published guidelines.

Now all of us know people make money implanting ICD's, including me. Given the time, the expertise, and the management issues involved with the 24/7 care of the patients with these devices, they should.

But no one wants to waste money to our health care system, either, and we must acknowledge there's been a heck of a marketing push to get more devices implanted. This has occurred because many patients who might benefit (legitimately) from these devices remain untreated and, yes, hospitals and medical device companies benefit handsomely from these procedures.

But before witch hunts ensue, we should take a moment and consider the implications of the DOJ's current actions.

First of all, I think most of us would acknowledge that every set of clinical guidelines published has holes. (One only has to look at the latest published atrial fibrillation management guidelines to note that the use of the newly-released anticoagulant dabigatran (Pradaxa) is not mentioned in those guidelines, rendering them already obsolete). Further, the studies upon which recommendations are made in published guidelines are often made on relatively weak data or by people with substantial industry ties. Further, prospective randomized trials are rarely used to make those recommendations.

Simply put, there is no way a published document can cover every clinical circumstance a doctor might encounter when he or she is in the trenches with an individual patient.

So this begs a simple question: If guidelines are not perfect and we must accept that doctors must deviate from them from time to time to work toward the best interest of their patient, what IS the percentage of care (in this case, ICDs) that SHOULD fall outside of guidelines?

Is 0% the correct number?

Clearly, no.

Is 5%, 10%, 15%, 20%, 22%?

The reality of this situation is that no one knows.

But that does not seem to be stopping the DOJ from investigating doctors for their criminal intent...

... based on the guidelines, of course.


Al-Khatib SM, Hellkamp A, Curtis J, et al. Non-evidence-based ICD implantations in the United States. JAMA 2011; 305:43-49.

Dr. Rich over at the Covert Rationing blog appropriately rips the abuse of the ICD guidelines in his must-read essay.

John Mandrola, MD, another EP, gives his take.

Larry Husten, at Cardiobrief, summarizes.

21 Jan 2011: An now, thanks to new SCD-HeFT data, maybe the 40-day wait period post-MI for ICD's is not such a good idea. Oh wait, that's not in the guidelines.


Dennis said...

It is sort of damned if you do and damned if you don't. My father died suddenly at forty-eight in 1964 and had been discharged from the military in his late 20's with 'heart trouble'. My grandfather died at sixty-three of a 'heart attack'... I was diagnosed with HCM at thirty-seven and got away with beta blockers until sixty-eight when Afib and SVT surfaced. A year later my local EP decided I was a ICD candidate. Due to setting problems I have been shocked inappropriately more than appropriately but I suppose its a gamble worth taking considering the shortened life of my family.
I have yet to suffer a Ventricular event but who is to say what the future might bring....

DrWes said...

Dennis -

It is sort of damned if you do and damned if you don't.

I think it's leaning heavily toward the "damned if you do" side of the equation now.

Anonymous said...

Dr. Wes, I'm astounded! "Before witch hunt begins"? How about before seeking some solutions? No perfect guidelines? I should think there are tons of scientific (this is science, isn't it?)papers, practices, theories that aren't perfected. You (EPs) have a problem. I'd like to see you try to tackle them. I'd be happy to see you try to get that number down to 10%. OR, rather than trying to fix the problem, how about we just raise your taxes so docs can continue as custom, but the costs will be covered. I have no idea how you want to approach the issue of the patients that are harmed. Gosh, THAT rings a bell...something about "first do no harm"?

DrWes said...

Anony -

Ah, yes, always love this perspective: that doctors are always out to screw patients and implant ICDs because we're just in it for the money. (As if there is no malpractice concerns and doctors are nothing more than greedy scumbags.)

Look, there are real concerns about cost, and yeah, we need to do a better job educating implanters about ways to be darn sure these devices are indicated, but I'd LOVE to know where you came up with that "10%" number.

Oh, yeah, forgot, you don't have to.

But to be fair, there has been a long-standing effort to understand the current state of affairs in our profession and the NCDR database, mandated by CMS, was part of that effort. Now the results are in and before ANYONE can work toward a solution, here comes the DOJ.


Anonymous said...

Dr. Wes, Where did I say the problem was due to greedy docs that just want to screw the patient? And "scumbag" isn't even this grandma's vocabulary. I don't blame (your words) greedy docs, but I was astounded by the lack of desire to tackle the problem. You seem to shrug your shoulders and - in bold font - end with "nobody knows". Doc, that is one scary attitude for a physician/scientist.
Regarding the "10%" - yes, it was entirely arbitrary. The study says we have a 22% problem. Not expecting perfection (remember the problem with the writing of guidelines), I would be happy if we can reduce that 22% to 10% that fall outside the guidelines. You know... reduce unnecessary harm and start to bend the curve. If those are not reasonable goals, then sir, I am as appalled by your perspective as you are with mine.

Ian said...

I will point out that the DOJ investigation seems to not be about following guidelines per say, but is instead about billing Medicare. When CMS made their ICD coverage decisions, they had very specific timing requirements (>90 days after revascularization, etc...). While these may be irrational in many situations (such as the post CABG patient with a low EF who needs a PPM), we're stuck with them for now. Billing Medicare for an ICD outside these "rules" is technically fraud, and that's what this investigation is about.
When clinical judgement (or guidelines) run into insurance coverage differences, there's no really good answer. Does anyone remember the gap between the ACC/HRS guidelines for SCD-HFT indications and the CMS decision? There was about a year period where you had to recommend ICD implantation to patients and then tell them that they couldn't get one unless they paid for it themselves.

Anonymous said...

Question for Dr. Wes: How would you approach a day three post CABG patient (3VD with a severely decreased EF of 20%) who develops complete heart block requiring a PPM? Would you place an ICD knowing that the EF might improve or place a PPM knowing that it may need to be removed and reimplanted with an ICD?

Anonymous said...

I am an implanting EP & have implanted at different hospitals over the last 5 yrs since the registry was formed. I strive to follow the Guidelines as strictly as clinically reasonable in my judgement, sometimes to the chagrin of referring Cardiologists/other MDs eager to offer ICD therapy for a variety of reasons. I acknowledge much of the complexities of the issues raised by both sides regarding whether implanters as a group are doing a good job or bad, based on the JAMA article/guidelines.
With that said, a strong concern I have is the measurement bias the Registry data has, and thus the JAMA observations are based. Almost all hospitals I have implanted the onerous data calculation responsibilities for the multipage ICD registry form on each patient are completed by a non physician. In filling out the very detailed and rather unwieldy data collection forms, these people usually have not complete knowledge of the clinical data, even what are the specific ICD Guidelines, or sometimes what the exact indication the implanter has identified in any given patient. How many cases in the Registry and thus used in the JAMA article were inaccurately deemed a non-guideline ICD in apt with a borderline + troponin in hospital in the days preceding not due to an acute MI, but labelled an acute MI pt on the Registry forms? How many NICM pts were inaccurately labelled as having Class I CHF just because the chart data was unavailable was incomplete or not easily apparent to the person responsible for completing the form? How many pts labelled as "new" CHF (<3 months on optimal med tx) actually had more a more longstanding CHF/cardiomyopathy which the implanter new and may have even documented but was not correctly recognized by the data collector? It also may be that EPs are not slightly better at following the guidelines as the article and critical readers of the JAMA study suggest but they are slightly better at helping with the correct data entry for the Registry or better at documenting to help other non physicians complete the data collection more accurately. I think the JAMA investigators, the HRS-ACC, the NCDR, and the DOJ should exhaustively investigate this potential bias before making any other conclusions. I fear garbage in equals garbage out.

Jodi said...

Anon 12:37 - Medicine is science, but it is so far from being a black and white science that we can never logically fit all those scientific studies into a workable mold that benefits everyone or the picture as a whole. If you or someone you love does not fit into the workable guidelines, because you have extraordinary circumstances not neatly fitting into those "guidelines", you would want your physician to make their decision based on your clinical picture, not some broad guidelines that you do not fit into. If physicians are forced to follow them by penalty, then they are not "guidelines" at all. Perhaps they could get that number down to 10%, but at what cost to patients lives? Is getting that number down more important than having our medical practitioners make clinical judgments based on their thought processes with the always distinct patient sitting in their office?

As a nurse and an American who pays attention, I completely understand why physicians like Dr. Wes might feel as though the American public views them as greedy. It's all the rage these days. Your statement that THEY should get the tax increase speaks to that mentality, even if you did not mean it that way. Americans too often speak as though they expect at least near perfection from their physicians and how they get paid too much for the most intense and high requirement career choice any human being can possibly make; while too few people can truly grasp either the road and the extensive sacrifices they must make just to become physicians, or the continued incredibly emotional, spiritual, physical, and intellectual challenges they sustain while working as physicians. I feel it for them, and it makes me sad that they appear not only unappreciated these days, but often attacked, including by our president. The consequences of their daily job decisions are extraordinary. If you worked in health care yourself, I am sure you realize that. It is tragic how our physicians are too often treated by people these days. I'm pretty young still, and by the time I reach my golden years, I fear too few will be around to endure the huge sacrifices REQUIRED of that career choice in the face of an ever growing unappreciative and accusing public.


Anonymous said...

Hopefully the HRS involvement can provide the DOJ some clinical context beyond what they would get from media coverage of complicated technical/clinical topics.