A Lawyer's Perspective on the DOJ's Investigation of Implantable Cardiac Defibrillator Use

From the lawyer-published "Healthcare Compliance Blog:"

I predict that the DOJ will be:

1.Continuing its efforts to deal with providers in an open and collaborative manner.
2.Notifying more hospitals that they are under investigation relating to ICD billing.
3.Making additional inquiries of hospitals regarding this matter.
4.Investigating doctors who have patterns of high ICD implantation rates, coupled with a potential lack of medical necessity. The medical necessity issue poses risks to both physicians and hospitals.

These are not really hard predictions to make, though I would argue that the DOJ has been anything but "open and collaborative" as they have imposed a gag order on the Heart Rhythm Society during their current investigation.

But we must acknowledge there are implanters who have scammed the system and they should be held accountable for their actions. But for the myriad of physicians who are implanting devices appropriately, no one quite knows what to do with their patient's since the government's CMS-directed guidelines are so out of date. As I mentioned before, CMS wants doctors to use their ICD guidelines based on data from 2005 that ignores the more recently published (and less restrictive) guidelines published in 2008.

We are now seeing the Draconian and covert methods that will be used to impose restrictions on our patient's care. This model will serve the government operatives for other expensive technologies, too, like hip replacements, spinal fusions, and the like.

Whether the government begins to prosecute doctors for using the newer ICD implantation guidelines remains to be seen, but the mere specter that they're looking has already achieved the government's goal since no one wants the expense and notariety of a legal investigation to contend with and as a result, ICD implantation rates are currently dramatically reduced.

Mission accomplished.

-Wes

The MRI-Safe Pacemaker

Magnetic resonance imaging (MRI) scanners are one of the most effective ways to follow soft-tissue and vascular diseases in the body. Unfortunately, sometimes these patients also have heart disease that requires that a permanent pacemaker or implantable defibrillator be installed for control of heart rhythm abnormalities. For these patients, follow-up of their soft tissue tumors is impaired because MRI-safe pacemakers and defibrillators are not available on the market, especially for patients who are dependent on their pacemaker for their heart to beat at all. Fortunately, some investigators (in the US and Europe) have devised special protocols for non-pacemaker dependent patients to undergo MRI scans when they are clinically required. The FDA still frowns on this practice, however.

Studies presented by Sommer et al and Nazarian et al in this issue of Circulation offer further promising evidence in this regard. As with the previous studies, however, the authors acknowledge a multitude of limitations that prevent broad applicability of the results. Furthermore, one of these studies was not entirely free from concerning outcomes with the potential for serious clinical events. We view these results as consistent with our previous message that, on a case-by-case basis, the diagnostic benefit from MRI outweighs the presumed risks for some pacemaker and ICD patients. However, the FDA remains firm in its belief that those risks have not yet been characterized and mitigated sufficiently to justify the routine use of MRI in those populations.

In February of this year, Medtronic began a trial overseas with a new MRI-safe pacemaker called Enrhythm MRI. The was trial recently announced in Canada as well. It will probably be a bit longer before we see the trial spread to the United States, although it looks like the centers have been selected that will participate.

There are several issues with MRI's that can cause problems with conventional pacemaker and defibrillator systems:

• Usually the most common is interference with sensing the patient's underlying rhythm (oversensing, usually of noise, causes the pacemaker to inhibit its output, or undersensing causes the pacemaker or defibrillator to not be able to see the underlying rhythm and may cause pacing at inappropriate times)


• Alteration in programming (like reverting to a power-on reset mode of pacing or actual damage to the circuitry)


• Changes in pacing thresholds, perhaps due to lead movement (torque) or local heating.

A short review of these issues (with references) can be found from this piece from the University of Utah.

Medgadget also has a an even better overview of Medtronic's study and the technology in place to counteract these issues.

I just hope that someday MRI-safe capabilities will eventually become a standard feature in all cardiac devices marketed. After all, patients may have their pacemakers for years before the need for an MRI arises.

-Wes

Oral Communication in the Wireless Era

I was shooting hoops with my son behind our garage, the other day. He demonstrated how ridiculous and old man can look next to an adolescent with spring-loaded knees and an eagle eye for the basket. It was humbling to say the least.

Our basketball setup is one of those portable units, set up right next to the garage. We were deeply involved in a game of “HORSE” when suddenly, just as I was planning a perfect “swish” from the corner, the electric garage door opened behind me. The sudden unexpected nature of this event startled me and I watched my perfect “swish” transition into an “air ball.” After the brief adrenaline rush subsided, my wife drove up and asked, “How’s it going?” with a big smile on her face – not realizing that her wireless transmission to the garage door mechanics had precipitated, at least in part, my basketball demise at the hands of my son.

It dawned on me that a similar event probably occurs daily in operating rooms and electrophysiology labs around the country with the advent of wireless implantable defibrillators. You see, both Medtronic and Boston Scientific have defibrillators that can communicate wirelessly with their respective programming computers. It’s a handy feature, in many respects.

But today, as I was replacing an older defibrillator with a new wireless model, a subtle, yet significant event occurred.

First, let me say that no one perished as a result of what happened. No one was initially aware that anything had even occurred. But I suddenly realized it.

At first, I became aware of a subtle background sound across the room: * tap * * tap * * tap * * tap *. I kept working and had just replaced an old defibrillator with a new wireless model. * tap * * tap * * tap * * tap * *tap *. And then I looked up at the monitor. Much to my surprise a dramatic change in the EKG characteristic was there. I hadn’t expected that. It seems the person controlling the wireless programmer was testing different parameters on the device quietly in the background and this person was pacing only one lead rather than both leads as part of the device checking process. This programming change dramatically changed how the EKG appeared to this startled surgeon.

Checking these parameters, by the way, is perfectly appropriate. Every device has a series of tests that are performed on the device to assure that it is receiving signals from the leads within the heart correctly, that no lead was damaged during the device change, etc. No, this was not my gripe. That’s what you WANT people doing.

What bothered me was the lack of verbal communication between the person performing those tests and the operating physician. You see, the doctor performing the surgery should know when a programming change is being made to their patient’s device, just in case something is NOT done correctly or if there was a problem discovered. It avoids that startled rush of adrenaline that occurs when the garage door suddenly activates without your knowledge. Doctors don’t like it when things happen they don’t know about while their operating on a patient. Trust me on this.

So if you are a device representative or nurse in a lab or operating room responsible for performing programming of any wireless device, let the doctor know what you’re about to do before you do it. Tell him something like “I’m going to test the threshold of the right ventricular lead now, OK?” and wait for the doctor to acknowledge he is aware that changes are being made. Always, always, always keep the oral communication going when wirelessly communicating with these new medical devices.

Doctors will appreciate it, and patients will certainly benefit.

-Wes