More on the DOJ ICD Investigation

Edward J Schloss, MD reviews comments made at HRS regarding the recent DOJ investigation of ICD implantation indications on Cardiobrief :

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.

...


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 said that penalties for unacceptable deviations are still being determined.  Penalties under the false claim act can recover up to triple 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.

Good stuff.  Read the whole thing.

-Wes