"Reasonable and necessary" redefined for Medicare
This article was originally published in Clinica
The US Centers for Medicare and Medicaid Services (CMS) is having another stab at defining what criteria it uses for determining whether a product is "reasonable and necessary", and thus fit to be covered by Medicare. But this time, CMS intends to address the subject as a guidance document similar to those issued by the FDA. In 1989 and again in 2000, the agency proposed addressing the issue through regulation, but backed off both times because of industry's objections to the use of cost effectiveness as an important criteria.