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    Lessons from the Department of Justice's Investigation of ICD Implants

    September 07, 2012

    Last Friday Modern Healthcare reported many hospitals across the United States have received letters from the Department of Justice (DOJ) about their implantation of ICDs . The letters reportedly asked facilities to assess their compliance with that national coverage policy and assess their liability for non-compliance. Importantly, the DOJ’s focus is not on medical necessity; it is on compliance with the national coverage policy

    The expectation is that many hospitals will be fined for implanting devices outside the parameters of the coverage decision. Lower fines and penalties may be applied to procedures considered medically necessary but not covered, and some procedures performed outside of specified time periods may not be penalized at all. It is likely that the harshest penalties will be applied to procedures that were not covered and also considered to be not medically necessary. SCAI believes the implication of these letters is that hospitals would do better to self-assess any wrongdoing now and settle with the government before the government further investigates, potentially levying heavier fines.

    The take-away for interventional cardiologists and their facilities is to ensure their practices are complying with the two major national coverage decisions applicable to procedures they may perform:

    All participating providers in the Medicare program are legally bound to know the coverage policies before submitting claims. Ignorance of the policies is not considered to be a valid defense. 

    A false claim is a submission for a procedure that one knew, or should have known, was not covered. When a provider knows a procedure is not covered under a national policy, then it may be billed to the patient directly as long as the patient has signed an appropriate Advance Beneficiary Notice. For information on how to use the Advance Beneficiary notices, see SCAI's recent Coding Q&A article, “What to Do When Patients Request Procedures Medicare Doesn’t Cover".

    It is important to note that Medicare beneficiaries have the right to appeal national coverage policies and may receive coverage in this manner, but providers may not appeal coverage policies.