May 12th, 2012
HRS 2012: More Clarity on DOJ ICD Investigation, ‘Incidental PCIs’ Still Excluded
Thursday morning at Heart Rhythm Scientific Sessions 2012, Suneet Mittal MD of Columbia University gave a detailed account of his group’s experience with a Department of Justice investigation of ICD implantation outside of NCD guidelines. The talk served to amplify and clarify points made in his perspective in JACC written with Jonathan Steinberg MD, in March 2012.
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 CardioExchange.
In his HRS discussion, Mittal was careful to distinguish between a CMS audit and a DOJ investigation. CMS is responsible for enforcing National Coverage Determinations (NCD). He indicated that the NCD for ICD implants is unique: “this is the first time in the history of US medicine that a National Coverage Decision is being nationally enforced.” To CMS, the NCD is “analogous to the 10 Commandments” with little room for nuance or interpretation.
In contrast, the Department of Justice serves as a bridge between CMS and clinicians, and has the ability to exercise what Mittal termed “incredible prosecutorial discretion.” Their charge is enforcement of the False Claims Act and Mittal found them to exercise more flexibility than CMS.
Mittal’s group was asked to defend 8.7% of one of their institution’s ICD implants that had been flagged as falling outside the NCD. After individual case review, they were able to classify most of the cases into five “buckets” that they felt represented medically indicated procedures that fell outside the NCD. This discussion is detailed in theirJACC article.
Thursday’s talk gave some inkling of “the rest of the story” not revealed in their JACC account. Mittal was able to discuss the instances in which the DOJ seemed to agree or dispute the physician justifications for ICD implant.
Justice agreed with some but not all of Mittal’s group’s interpretations. Acceptable ICD indications to the DOJ reviewers included:
- Pacing indication in patients in ICD “waiting period,” i.e. post CABG heart block with preexisting LV dysfunction.
- Recent troponin leak misclassified in coding as a myocardial infarction in patients otherwise indicated for ICD.
- Sustained VT at EP study – the study must however not be performed per a routine pattern, i.e. after all CABGs. One must also be able to supply documentation of the induced arrhythmia.
- Genetic conditions predisposed to sudden cardiac arrest.
- Bridge to cardiac transplant – the patient must have clear plan for transplant, ideally with the patient already listed.
- Generator replacements – these are “likely to be no problem.”
Unacceptable indications for ICD implant to the DOJ reviewers included:
- Near syncope rather than true syncope in high risk patients
- Recent “incidental PCI” in a patient otherwise indicated for primary prevention ICD. Mittal gave the example of an established heart failure patient with LV systolic dysfunction getting a stent in a distal coronary vessel, who is then promptly sent for ICD: “that will be subject to the full exclusionary rule” necessitating a 90 day waiting period.
Mittal said that penalties for unacceptable deviations are still being determined. Penalties under the false claim act can recover up to treble the monetary damages of the event. He added the DOJ would consider prior patterns of infraction and ongoing hospital corporate integrity agreements in assessing penalties.
Mittal’s institution has established a system of education and review to prevent further deviations to the NCD that are not clinically justifiable. This includes instructions to coders, morning peer review conference call prior to all ICD implants, formal implanter standardized documentation, and post-hoc nursing reviews.
To get at the issue of ICD exclusion due to incidental PCI, he urged communication between ICD implanters and coronary interventionalists: “this begs for collaborative medicine.”
Based on his experience, Mittal made a few broader recommendations:
- ACC and HRS should request reevaluation and update of current NCD for ICD implant.
- Trials should be implemented to “close the gap” between NCD and commonly observed clinical situations.
- A national discourse is needed to add “clinical nuance” to the inflexibility of the NCD.