FDA Approval Does Not Mean What You Think It Does!

The Department of Health and Human Services’ (DHHS) Food and Drug Administration (FDA) is well known to Americans, as are their terms “FDA approval” and “off-label usage.” Unfortunately, the inappropriate usage of these terms has created confusion because of misinterpretation, which has damaged the doctor-patient relationship, as well as the incorrect conclusion that FDA approval enabled product use and insurance (Medicare) reimbursement for both the product and physician rendered services. The unintended consequences of misuse of these terms by companies, the media, and individuals have inappropriately interfered with the delivery of health care. Furthermore, FDA approval does not determine product reimbursement, which is solely determined by CMS [Centers for Medicare and Medicaid; formerly, Health Care Financing Administration (HCFA)], which, after FDA product approval, determines whether or not reimbursement should be provided. However, CMS’ non-uniform regional reimbursement policy enables Medicare contractors’ to use selective and indiscriminate reimbursement, which limits patient access to selective FDA approved products, according to their area of domicile. Fortunately, these issues, which have adversely affected patient care, are identifiable.

To read the rest of the article, please download the PDF. Reprinted with permission from the August 2010 issue of The Journal of Invasive Cardiology.