What To Do When Federal Investigators Knock On The Door

For more than a year now the federal investigation of hospitals suspected of improperly implanting ICDs has been the subject of considerable rumor and speculation. Now, two cardiologists who were involved in a federal audit at one hospital have published a detailed account of their experience.

Jonathan Steinberg and Suneet Mittal are Columbia University-affiliated electrophysiologists who also direct the EP program at a large suburban nonteaching hospital. In a special article published in the Journal of the American College of Cardiology, the two authors describe the audit process and subsequent events in the hope that their experience “might provide valuable lessons” to others involved in similar cases.

The initial government analysis had found that 229 cases, representing 8.7% of all de novo ICD implants for primary prevention between 2003 and 2010, did not warrant coverage. Following a more detailed review of the medical records, the authors report that a much smaller number of cases, 34, representing 1.3% of all implants, were truly not indicated. These cases mostly occurred after bypass surgery in the setting of non sustained VT and/or a positive EP study, according to the authors. By contrast, a small number of cases had a clear secondary prevention indication, but the records for the earlier cardiac arrest or VT event were at another hospital.

Most of the cases were somewhat more ambiguous. Steinberg and Mittal list five common types of cases which were difficult to categorize and which “highlighted the complexity of adjudicating between clinical practice and the contemporary regulatory environment.”

1) secondary prevention indication when the presentation was syncope in the setting of cardiomyopathy;

2) concurrent trivial cardiac enzyme leak or enzyme elevation for non-MI reasons but coded as acute MI;

3) ICD implantation when the precipitating acute device need was bradycardia and pacemaker indication;

4) incomplete or incidental percutaneous revascularization not anticipated to have any meaningful effect on chronic LV dysfunction; and

5) ICD implantation near the end of the 90-day post-revascularization period when the patient was admitted for heart failure.

The authors help dispel fears about government intransigence:

We found the government legal team highly knowledgeable and informed. The lawyers listened thoughtfully to our presentation about the results of our review and how we viewed the balance between complying with the letter of claims regulations and the subtleties of clinical practice. They were quite sensitive to avoiding situations that could present harm to the patients simply to satisfy the coding guidelines and, in large part, were receptive to the “exceptions” that are detailed in the preceding text.

Following the review, coding procedures were changed and implanting EPs now carefully document the indication for the ICD  and include all relevant mitigating circumstances. All cases are preceded by a “concurrent peer review during a morning conference call of practicing EPs” and quality assurance reviews are performed afterwards.


  1. Edward J. Schloss MD says


    Key point not addressed above: We still don’t know the outcome of the DOJ investigation.

    If DOJ agrees with Steinberg and Mittal and approve the “gray area” implants, the EP community should be happy. If they disagree and level severe sanctions, a new era of government oversight is confirmed and the game changes.

    Until the outcome is reported, we really don’t know where we are. The written perspective alone should not be misinterpreted as something that “dispel(s) fear of government intransigence.”

    Ethical electrophysiologists are not at all interested in putting ICDs in patients that do not need them. We are, however, best equipped to make these decisions in the context of a private doctor-patient relationship. Delivering quality medical care is nuanced and needs to adapt to changing data. Rigid government imposed guidelines take away this flexibility and can put our patients at risk.



  1. […] Not long after Al-Khatab and colleagues published their account of “non-evidence based” ICD implants in JAMA in January 2011, the US Department of Justice launched an investigation of numerous US hospitals looking for ICD implants outside NCD rules.  This action appeared to have a “chilling effect” on ICD market growth.  Steinberg and Mittal’s account of their experience with a DOJ investigation was a topic of discussion in the blogosphere and was covered by Cardiobrief. […]

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