I have been addressing the Department of Justice’s national investigation into hospitals’ Medicare billings for Implantable Cardioverter Defibrillators (ICDs) in recent posts. I predict that the DOJ will be:
- Continuing its efforts to deal with providers in an open and collaborative manner.
- Notifying more hospitals that they are under investigation relating to ICD billing.
- Making additional inquiries of hospitals regarding this matter.
- Investigating doctors who have patterns of high ICD implantation rates, coupled with a potential lack of medical necessity. The medical necessity issue poses risks to both physicians and hospitals.
Here are the takeaways:
- The government’s collaborative approach is a good thing. But there are nuances and themes, especially with respect to the application of the elements of the National Coverage Decision, about which hospitals and physicians must be aware. Doing a self-audit without understanding the background and context, especially without the assistance of professionals who are well-versed in the intricacies of the investigation, can result in wasted efforts and perhaps even a false sense of security.
- Hospitals that have not received notice that they are under investigation should not take that as a sign that they will not receive notice in the future.
- This issue will not be limited to hospitals. Physicians and others who take the position that this is solely a hospital billing issue are mistaken.
- Hospitals and physicians that are not currently under investigation can take proactive steps to diminish their legal, financial and reputational risks going forward.
Stay tuned on this investigation! As always, comments and questions are welcome.
Frank Sheeder, chair of DLA Piper's 
