A national coverage determination (NCD) is a United States nationwide determination of whether Medicare will pay for an item or service.

In August 2013, the Centers for Medicare & Medicaid Services (CMS) published a Federal Register notice, (78 FR 48164-69), updating the process used for opening, deciding or reconsidering NCDs under the Social Security Act.¹

Medicare coverage is limited to items and services that are reasonable and necessary for the diagnosis or treatment of an illness or injury. The 2013 notice further outlined an expedited administrative process to remove certain NCDs older than 10 years since their most recent review, thereby enabling local Medicare contractors to determine coverage.¹

The Secretary of the Department of Health and Human Services determines whether a particular item or service is covered nationally by Medicare, which essentially grants, limits or excludes national coverage to all Medicare beneficiaries. NCDs are made through an evidence-based process, with opportunities for public participation. In the absence of a national coverage policy, an item or service may be covered at the discretion of the Medicare contractors based on a local coverage determination.²

NCD formal requests can be internal, meaning it was initiated by CMS, or external meaning it was initiated by an individual or entity (e.g., manufacturer). Typically, a requester is a Medicare beneficiary, a manufacturer, a physician or a physician professional association.¹ A request may be to establish, limit, or remove coverage. In general, NCD formal requests should: 

• Not be marked as a draft document, and be clearly identified as “A Formal Request for a National Coverage Determination.”¹ 

• Identify the benefit category (Medicare Part A or Part B) to which the requester believes the item or service applies and contains enough information for us to make a benefit category determination.

• Contain sufficient, supporting documentation, with a complete description of the item or service in the request and scientific evidence supporting the clinical indications for the item or service. 

• Describe the proposed use of the item or service, including the target Medicare population, the medical indication(s), and whether the item or service is intended for use by health care providers or beneficiaries.

• Include information regarding the use of an item or service subject to FDA regulation as well as the status of current FDA regulatory review of the item or service involved. An FDA regulated item or service would include the labeling submitted to FDA or approved by the FDA for that article, together with an indication of whether the article for which review is being requested is covered under the labeled indication(s).¹ 

If a requester submitted an application to the FDA for premarket approval or 510(k) clearance, a copy of the ‘‘integrated summary of safety data’’ and ‘‘integrated summary of effectiveness data’’, or the combined ‘‘summary of safety and effectiveness data’’ portions of the FDA application would also be included in the NCD request. Items or services that are eligible for a 510(k) clearance by the FDA, the request must include identification of the predicate devices to which the item or service is claimed to be substantially equivalent.¹

After CMS receives a complete, formal request, publication of a tracking sheet on the CMS website enables interested individuals to participate in and monitor the progress of the review. The tracking sheet contains a reference number, the name of the issue under consideration, requests for public comments, and summarizes the significant actions we have taken. A formal evidence review to determine whether or not an unbiased interpretation of the available evidence base supports or refutes the requested coverage in whole or in part. A proposed decision is normally issued for public comment within six months of opening the NCD review. CMS provides 30 days for public comment on the proposal. Within 60 days of the public comment period, a final NCD is issued.¹ 

90 percent of Medicare policies are established at the local level, providing contractors with immense authority over payment policy in a given state.²

NCD decision timeframes can vary depending on whether or not CMS commissions a technology assessment from an outside entity, or convenes the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to discuss the quality of the evidence, or whether a clinical trial is requested.¹

1. Department of Health and Human Services. Revised Process For Making National Coverage Determinations. Baltimore Maryland: Centers for Medicare & Medicaid Services; 2013.

2. National and Local Coverage Determinations. Acr.org. https://www.acr.org/Advocacy-and-Economics/Radiology-Economics/Medicare-Medicaid/Coverage.