Certifying To Medical Necessity Under FDA

Foley Partners Lawrence Vernaglia and Nathan Beaver authored an article that appeared in Health Law360 on April 21, 2011 titled “Certifying To Medical Necessity Under FDA.” The authors discuss Certificate of Medical Necessity (CMN) in the context of the U.S. Food and Drug Administration (FDA), including a detailed summary of the implications and consequences of signing a CMN. They state that recent regulatory actions against drug and device manufacturers have demonstrated the FDA’s increased use of consent decrees to address regulatory violations. The authors add that health care providers should confer with internal risk management and conduct due diligence into the medical necessity and lack of alternatives for a recalled drug or device before executing a CMN.