Medtronic, Inc., Boston Scientific and five other medical device manufacturers have been accused of coordinating a nationwide sales campaign which illegally promoted their surgical devices for off-label uses in a recently unsealed whistleblower lawsuit. According to the lawsuit, the companies encouraged doctors and hospitals to use perform cardiac ablation as an inpatient procedure, greatly increasing the costs and thereby defrauding the federal Medicare reimbursement program. Additionally, the companies urged doctors to use the ablation devices even when less invasive alternatives were appropriate, hospitals were advised how to inflate Medicare reimbursements and cash kickbacks were paid to the doctors and hospitals.
The illegal kickbacks and other means of enticement resulted in inpatient misuse of surgical ablation procedures normally used to create controlled lesions or scar tissue on the heart muscle for treatment of atrial fibrillation. For the majority of patients, cardiac ablation can be performed safely in an outpatient procedure at a much lower cost and inpatient admission was not medically necessary.
As the country debates the need for of health care reform and bringing spiraling medical costs and premiums under control, it is even more imperative for law breakers who add to our health care misery be brought to task for their greed and fraud. Avoidable medical mistakes, profit-at-any-cost pharmaceutical manufacturers and unscrupulous medical device manufacturers are part of the problem; addressing them effectively through regulation, oversight and reform is part of the solution.
Richard J. Arsenault, 2011
