DOJ Hands Heart Rhythm Society and Hospitals Its Decision on Defibrillators

Today, the Heart Rhythm Society issued the following cryptic email to its membership explaining the results of the three-year investigation by the Department of Justice (DOJ) audit of implantable cardiac defibrillator (ICD) implantation procedures:

Over the past three years, the Heart Rhythm Society (HRS) has served as an advisor to the Department of Justice (DOJ) on the issue of implantable cardiac defibrillator (ICD) procedures. We made this difficult decision to work with the DOJ to protect patient access to life saving therapies, and to ensure that the federal government was aware of and considered evidence-based medicine and the realities of clinical practice during their investigation. Given that this process would have proceeded with or without HRS involvement, we believe that acting in this capacity was in the best interest of our members, patients and of the profession.

As a result of input from HRS and others, the DOJ has created several categories that contain clinical scenarios that fall outside of those covered by the National Coverage Determination (NCD) for ICD therapy but that the DOJ will be excluding from enforcement in this investigation. Unfortunately, in some circumstances our counsel was not accepted, and we are troubled by some aspects of the final decision. However, we believe the receptiveness to our counsel regarding the application of ACC/AHA/HRS guidelines for ICD implantation helped to mitigate the number of clinical scenarios considered inappropriate and therefore, subject to penalties.

Our priority moving forward will be to assist the heart rhythm care community to manage the patient care pathway in the post-DOJ decision environment and address its limitations. The misalignment between the Medicare NCD and the ACC/AHA/HRS guidelines creates gaps between the payment policy and clinical decision making and places our physicians and their patients in an untenable position. We will continue to work in partnership with the American College of Cardiology (ACC) and other key stakeholders to address this problem and to align payment policy with evidence-based medicine.

Changing Medicare policy is a lengthy process. In the meantime, we encourage physicians to work with their hospitals to improve transparency and documentation of clinical decision making. Our guiding principles should be accurate documentation; clear thinking about alternative strategic approaches; and working with our hospitals to ensure our patients' needs is the first priority. HRS will keep you informed in the months ahead on our progress to address the clinical indications that permit payment for these life-saving therapies as well as make educational tools available to respond effectively.

So what have doctors like me learned from this notice? 

First, the investigation of ICD implantation criteria and the Heart Rhythm Society's involvement in the investigation began long before it was announced to the general HRS membership on 20 January 2011.

Second, specifics of what the DOJ's actual decision were lacking in this email.  After doing a bit of digging on the interwebs I found a copy of this e-mail (pdf) that was sent to hospitals by the DOJ.  In it, we find that the DOJ was willing to permit certain clinical scenarios outside the 2005 National Coverage Decision for ICDs, provided doctors clearly document the rationale for the ICD and it falls within one of their clinically reasonable "buckets."  If not, penalties will be likely forthcoming.

Third, the American Heart Association (AHA) noted there were problems clarifying the DOJ's decision, stating:

However, this proposed settlement framework, as we understand it, does leave one area that may be problematic.  The American Heart Association believes that some situations, categorized in the DOJ's proposed settlement as "previously qualified," would be justified even though technically in violation of the National Coverage Determination.  In this category, a patient meets criteria to have an ICD implanted but it is not implanted.  Subsequently, the patient has a new cardiovascular event that resets the NCD's time limitation but the physician makes the medical judgment that implantation of the ICD is medically necessary and justified even if not within the NCD timeline.

Fourth, the message for the ICD market in particular and other expensive medical technologies is chilling.  It is clear that any high-cost technology that is utilized outside a National Coverage Decisions may be subject to DOJ audit, irrespective of a local physician judgement or updated professional society guideline recommendations.

Most concerning for doctors in general, however, is how the DOJ made up its own new rules that it calls clinical "buckets" (with the secretive help of chosen "professional" societies) to apply on top of outdated Center for Medicaid and Medicare Services (CMS) MS National Coverage Decision rules, rather than asking CMS to update its anitquated rules to reflect changes in the current standards of care.  While the DOJ's Resolution model claims their model "does not replace, update or interpret NCD 20.4 and should not be relied upon or utilized in any manner to determine whether an ICD is payable by Medicare," it most certainly does.  With this new secretive rule-making approach, doctors are rendered powerless to adapt their practice medicine to its latest state of the art without later fear of retribution from the long arm of the law.

So dot your i's and cross your t's, good doctor.  Document everything, not once, but twice, and scan the strips of the arrhythmias into the medical record.  After all, if it ain't in the old CMS National Coverage Decisions or now, one of the DOJ's specially-created new "buckets," it ain't getting paid for.  Capisce?

And patients, expect to hear some more strange rules as to why you can't that defibrillator even though your doctor says, based on evidenced-based medicine, you need it, okay?  This is the way things are likely to be from now on it seems...

... more hoops, more random jumping, for all of us.

-Wes

Addendum 14 Sep 2012:  When the Feds Come Knocking - prior piece outlining my concerns with the DOJ's actions.