The Department of Justice (DOJ) provided guidelines to hospitals on Aug. 30 in an effort to resolve claims related to the DOJ’s implantable cardioverter-defibrillator (ICD) investigation.
The document contains instructions to review claims for questionable implantation surgeries and estimate the potential penalties. According to the American Heart Association (AHA), the DOJ consulted with individual experts and professional cardiovascular organizations, including the AHA, the American College of Cardiology and the Heart Rhythm Society, to determine the DOJ's proposed settlement framework.
“We believe that this approach will lead to a major reduction in the implantation of medically unnecessary or inappropriate ICDs,” the AHA wrote in a release.
The AHA expressed concern about one aspect of the proposed settlement framework: that is, some situations categorized in the DOJ's proposed settlement as previously qualified, which it wrote would be justified even though technically in violation of the National Coverage Determination (NCD).
“In this category, a patient meets criteria to have an ICD implanted but it is not implanted,” according to the AHA. “Subsequently, the patient has a new cardiovascular event that resets the NCD’s time limitation but the physician makes the medical judgment that implantation of the ICD is medically necessary and justified even if not within the NCD timeline.
“This issue could be addressed moving forward by conducting new clinical trials to provide sufficient scientific evidence to support implanting ICDs in ‘previously qualified’ patients," stated the association. "Also, CMS [Centers for Medicare & Medicaid Services] could consider re-opening the NCD to further discussion and review of any relevant interim data specifying the particular area(s) of needed change.”
The DOJ investigation is designed to eliminate billing fraud related to Medicare beneficiaries who received implantable devices. The proposed resolution model does not replace the CMS’ NCD, the DOJ wrote, and it is to be used only to facilitate the settlement of claims from its ICD investigation.