The medical device payment controversy rages on

Who will pay for investigational research? This seemingly endless debate assumes different guises as different aspects of the health care industry come under scrutiny. The latest wrinkle in the debate involves reimbursement for devices that are not FDA approved. My September column discussed the issue of funding investigational cancer therapies, specifically high-dose therapy and bone marrow transplant, as treatments for various malignancies. That controversy was centered on the use of FDA-approved drugs in settings beyond the labeled indications. However, the issue with medical devices is different. It involves implantable devices that the FDA says have not proven to be safe and effective.