The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires that the Secretary make available to the public the factors that are considered in making National Coverage Determinations (NCDs) of whether an item or service is reasonable and necessary. To do this, CMS is producing guidance documents similar to those used by the U.S. Food and Drug Administration. These guidance documents give the public - particularly individuals or organizations that might request an NCD - detailed information on the NCD process and related evaluation and decision-making factors.
Guidance documents represent the Agency's current thinking on a particular topic. They do not create or confer any rights for or on any person and do not operate to bind CMS or the public.