{"id":28970,"date":"2012-05-12T17:47:00","date_gmt":"2012-05-12T21:47:00","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=voices&p=28970"},"modified":"2012-05-14T15:02:31","modified_gmt":"2012-05-14T19:02:31","slug":"hrs-2012-more-clarity-on-doj-icd-investigation-incidental-pcis-still-excluded","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/05\/12\/hrs-2012-more-clarity-on-doj-icd-investigation-incidental-pcis-still-excluded\/","title":{"rendered":"HRS 2012: More Clarity on DOJ ICD Investigation, ‘Incidental PCIs’ Still Excluded"},"content":{"rendered":"

Thursday morning at Heart Rhythm Scientific Sessions 2012, Suneet Mittal MD of Columbia University gave a detailed account of his group\u2019s experience with a Department of Justice investigation of ICD implantation outside of NCD guidelines.\u00a0 The talk served to amplify and clarify points made in his\u00a0perspective in\u00a0JACC<\/em>\u00a0written with Jonathan Steinberg MD, in March 2012<\/a>.<\/p>\n

Not long after Al-Khatab and colleagues published\u00a0their account of \u201cnon-evidence based\u201d ICD implants in\u00a0JAMA<\/em><\/a>\u00a0in\u00a0January 2011, the US Department of Justice launched an investigation of numerous US hospitals looking for ICD implants outside NCD rules.\u00a0 This action appeared to have a \u201cchilling effect\u201d on ICD market growth.\u00a0 Steinberg and Mittal\u2019s account of their experience with a DOJ investigation was a topic of discussion in the\u00a0blogosphere<\/a>\u00a0and was covered by\u00a0CardioExchange<\/a>.<\/p>\n

In his HRS discussion, Mittal was careful to distinguish between a CMS audit and a DOJ investigation.\u00a0 CMS is responsible for enforcing National Coverage Determinations (NCD).\u00a0 He indicated that the NCD for ICD implants is unique:\u00a0 \u201cthis is the first time in the history of US medicine that a National Coverage Decision is being nationally enforced.\u201d\u00a0 To CMS, the NCD is \u201canalogous to the 10 Commandments\u201d with little room for nuance or interpretation.<\/p>\n

In contrast, the Department of Justice serves as a bridge between CMS and clinicians, and has the ability to exercise what Mittal termed \u201cincredible prosecutorial discretion.\u201d\u00a0 Their charge is enforcement of the False Claims Act and Mittal found them to exercise more flexibility than CMS.<\/p>\n

Mittal\u2019s group was asked to defend 8.7% of one of their institution\u2019s ICD implants that had been flagged as falling outside the NCD.\u00a0 After individual case review, they were able to classify most of the cases into five \u201cbuckets\u201d that they felt represented medically indicated procedures that fell outside the NCD.\u00a0 This discussion is detailed in theirJACC<\/em>\u00a0article.<\/p>\n

Thursday\u2019s talk gave some inkling of \u201cthe rest of the story\u201d not revealed in their\u00a0JACC\u00a0<\/em>account.\u00a0 Mittal was able to discuss the instances in which the DOJ seemed to agree or dispute the physician justifications for ICD implant.<\/p>\n

Justice agreed with some but not all of Mittal\u2019s group\u2019s interpretations.\u00a0 Acceptable ICD indications to the DOJ reviewers included:<\/p>\n