Wednesday, March 30, 2011

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appropriately, no one quite knows what to do with their patient's since the government's CMS-directed guidelines are so out of date.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.



Keith said...

Aside from the issue of outdated guidelines, how would you propose Medicare deal with the very real possibility that there are some docs overutilizing this procedure and are not only costing the goverment boodles of money, but possibly endangering patients lives? Especially since one of the principle complaints of Medicare is that it is so subject to fraud and abuse with estimates of huge sums going to inappropriate or downright fraudulent care?

If I am a payer, I want to follow the rule of Willie Sutton and go where the money is, and there is alot of it in cardiology; in particular cardiology procedures. So it is only natural that the feds are doing what I would do in this situation, which is to try and find the biggest puddles of waste and eliminate them.

DrRich said...

"It is certain that of all the forces capable of producing results in public affairs, fear is the most effective, since it can drive everybody to do his duty." - Cardinal Richelieu

Creating fear among EPs has been the obvious goal, and for obvious reasons. As you and Mr. Bush and Mr. Obama all say, mission accomplished.


Dennis said...

In the nearly three years I have had my ICD, I have been shocked more than a dozen times, once multiple times because of SVT... not once did it bring me back from the brink of death. Now this is not to say that might not be in the future, However thankfully my current EP decided to forgo shock from upper chamber origin and let the device stand by for its real purpose. Did I need an ICD? Well, probably yes. My father died of a MI (no doubt a deadly AF) at 48 and I was born with HCM and was suffering Afib and SVT. Good stewardship is a must in any medical field, but I laugh at the governments sorry excuse to save money when we are still spending millions studying the sex habits of gofer frogs...

Frank Sheeder said...

Keith, you say that the DOJ has "imposed a gag order" on the Heart Rhythm Society. As I understand it, the HRS has been voluntarily cooperating with the DOJ; it seems like the HRS would have had to agree to confidentiality. DOJ can't impose "gag orders."

Regardless of how it came about, how do you feel about a medical society cooperating with the DOJ in a national False Claims Act investigation involving its constituents and not being in the position to commmunicate openly about its activities? One school of thought is that it is good to have a professional society advocating for its members' interests and good medicine, while helping to root out "rogue physicians" that give the field a bad name. Another perspective would be that any cooperation should be done publicly.

Incidentally, while my predictions may seem fairly obvious, they are nonetheless based on my experience as an attorney over the last 23 years and specific indicators in the current investigation. I know phyicians work on data and experience-based judgment, not speculation, so I thought I'd clarify that.

Some day I'll recite for you the reasons why lawyers and doctors are really a lot alike, but I'm not sure you and your readers are ready for that yet! I recall back when the Clinton Administration was trying to reform healthcare, the president of the AMA said to the effect, "After we have the lawyers reform the health care system, we should have the doctors reform the legal system." I appreciated both the irony and the sentiment.

Regards, Frank

DrWes said...


I suggested the term "gag order." While HRS is cooperating with the DOJ, we (their membership) still are left in the dark as to what that "cooperation" entails and were told they were not allowed to discuss with us... Pretty close to a gag order...

Anonymous said...


I actually wonder if one cannot argue that the actual subjects of the JAMA study were the implanting physicians and institutions and that their personal information has been violated by this research and that this has caused actual harm to the subjects who are now being targeted by the DOJ.