In the United States, a national coverage determination (NCD) is a set of guidelines published by the Centers for Medicare and Medicaid Services (CMS) that defines the level of coverage that Medicare and Medicaid will allow for medical procedures, services, or supplies. The Medicare National Coverage process occurs over a nine-month period, with the services and procedures restricted to items that are deemed medically necessary and appropriate. In addition to the research undertaken by CMS itself, expert testimony and clinical evidence from outside sources that are relevant to the items under consideration are studied by the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) for the first six months. The final three months encompass a 30-day period for public comments and a 60-day planning session for implementation. CMS then publishes the national coverage determination guidelines, which are binding on all Medicare providers and vendors.
The Medicare Prescription Drug, Improvement, and Modernization Act, enacted by the United States Congress in 2003, changed several aspects of the national coverage determination process. Each year, CMS must issue a report describing the national coverage determinations that it completed during the preceding year. All NCD requests for covered items or services that require clinical trials or external assessments must be completed within nine months of the request. For those services that do not require additional evidentiary analysis, the process must be completed within six months. CMS must register all decisions on its website and solicit public comment and opinion, which it must include in the final report.
A national coverage determination does not set forth the dollar amount that CMS will pay for a service or item, nor does it specify a code for billing. It simply determines whether and to what extent CMS will provide coverage. When a particular service, procedure, or product is not addressed by a national coverage determination, the individual Medicare contractors may determine coverage under a local coverage determination (LCD), which only pertains to the geographic region and patient population served by that contractor. LCDs are not universally binding on other contractors and providers.
Any person may apply for or request a national coverage determination for a procedure, service, or item. CMS places its first priority on Medicare and Medicaid patients, who are already enrolled and eligible to receive services. A Department Appeals Board exists to provide a way to appeal the CMS decision within 60 days of its final decision. Both the Department Appeals Board and the Medicare Coverage Advisory Committee, which advises CMS on whether certain services are reasonable and medically necessary, consist of members selected for their expertise and training in a wide range of technical, medical, and scientific areas.