October 3, 2022

Volume XII, Number 276

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September 30, 2022

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Here We Go Again – DOJ Investigating ICD Implants

If you were involved with a kyphoplasty audit, this may sound familiar. A number of hospitals and health systems have recently been served with subpoenas by the United States Department of Justice regarding Medicare billing for implantable cardioverter defibrillators (“ICDs”). The DOJ is investigating whether hospitals billed Medicare for ICDs for patients who did not satisfy coverage National Coverage Determination criteria. For example, NCD criteria provides that Medicare does not cover implantation of ICDs in patients who lack a history of arrhythmia, even if their heart function indicates that they are at an elevated risk of sudden death due to arrhythmia, if the implantation occurred within 40 days of an acute myocardial infraction or within three months of a bypass surgery or angioplasty. The DOJ also is investigating the three largest ICD manufacturers regarding their communication with providers regarding Medicare billing – much like the DOJ’s past investigation of Kyphon as part of their kyphoplasty investigation.

The National Coverage Determination criteria can be found in the NCD Manual Section 20.4.

©2022 von Briesen & Roper, s.cNational Law Review, Volume I, Number 39
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About this Author

von Briesen & Roper’s Health Law Section provides comprehensive legal services to the health care industry nationwide as both general counsel and special project counsel. Our clients include integrated delivery systems, academic medical centers, community hospitals, Catholic-sponsored hospitals, rural and critical access hospitals, imaging centers, physicians and multi-specialty clinics, specialty hospitals, ancillary suppliers, home health agencies, nursing homes, hospices, assisted living facilities, mental health and AODA facilities, DME suppliers, laboratories,...

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