American Heart Association comment: Proposed Department of Justice Settlement Framework
Washington, D.C., — The American Heart Association supports the Centers for Medicare and Medicaid Services (CMS) and the Department of Justice (DOJ) in their efforts to eliminate billing fraud for implantable cardioverter defibrillators. But, it also is critical that such efforts not compromise quality of patient care, or infringe on a physician’s legitimate medical judgment concerning what is best for the patient. To that end, efforts to eliminate billing fraud must be balanced with allowing physicians to make expert judgments and determine care in consultation with their patients.
The American Heart Association appreciates the Department of Justice’s novel approach to resolving this matter. Rather than focus exclusively on reflexive enforcement for violations, the DOJ sought input from both individual experts and prominent cardiovascular organizations including the American Heart Association, American College of Cardiology, and the Heart Rhythm Society in shaping the terms of 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.
However, this proposed settlement framework, as we understand it, does leave one area that may be problematic. The American Heart Association believes that some situations, categorized in the DOJ’s proposed settlement as “previously qualified,” would be justified even though technically in violation of the National Coverage Determination. In this category, a patient meets criteria to have an ICD implanted but it is not implanted. 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. Also, CMS could consider re-opening the National Coverage Determination to further discussion and review of any relevant interim data specifying the particular area(s) of needed change.
The American Heart Association is committed to participate in an ongoing dialogue with CMS and other cardiovascular organizations to help address such issues. The experience we bring, based on our effective interaction in the area of performance measures, would allow this to be feasible. Ultimately, all such efforts, including the recent efforts to deal with inappropriate and/or wasteful use of limited resources, would improve physicians’ abilities to provide quality patient care.
Media contact: Tagni McRae, (214) 706-1383; firstname.lastname@example.org