Devices inserted into narrow or totally obstructed coronary arteries, to avoid the need for open-heart surgery, and which force the vessels to remain open, are referred to as “stents.” Major questions have been raised concerning the overuse of stents. In particular, there has emerged evidence of illegal kickbacks from stent manufacturers to physicians to incentivize stent placements, when appropriate medical justification was missing for a given patient. Such evidence prompted a formal investigation by the United States Senate Committee on Finance. The Committee concluded in 2010 that, at a single hospital, a single practitioner was responsible for the placement of as many as 585 unnecessary stents without clear medical indications, and were thus clear examples of fraud, waste, and abuse.
Indications for appropriate use of stents have been widely published, both in Europe and the United States. Generally speaking, there must be clear evidence for current, active coronary artery disease, either with usual patient physical exertion or inducible in the setting of stress testing. There should also be evidence of blockage in arteries which nourish those portions of the heart that have so far not sustained damage.
In addition to the cardiac stent fraud reported by the US Senate Finance Committee, in November 2011 the US Attorneys’ Office for the District of Maryland reported the conviction and sentencing of a Cardiologist to 97 months in prison. The sentencing was the result of an alleged scheme in which a physician submitted insurance claims of inserting unnecessary cardiac stents, ordered unnecessary tests and made false entries in patient medical records, in order to defraud Medicare, Medicaid and private insurers.
Failure to subject patients to appropriate selection criteria for invasive or non-invasive procedures, as well as failure to secure informed consent, constitute serious neglect of a physician’s obligations to practice safe medicine. Moreover, serious specific concerns have been raised on the practice of coronary stent placement, in particular, the value of stents in managing coronary artery disease, and whether adequate patient education and informed consent are consistently provided for this procedure.
Therefore, coronary stenting has gained the attention of regulators for safety, appropriate patient selection, compliance with patient education, and potential healthcare fraud under the False Claims Act.