Originally Published MDDI November 2003NEWSTRENDSCMS Clarifies Process for National Coverage DecisionsErik Swain

Erik Swain

November 1, 2003

2 Min Read
CMS Clarifies Process for National Coverage Decisions

Originally Published MDDI November 2003


Erik Swain

The Centers for Medicare & Medicaid Services (CMS) has clarified the process by which it makes national coverage decisions. The agency hopes it will enable industry to better track the progress of pending deci-sions, and encourage more public participation.

In a recently released notice, the agency explained, among other things, that firms with a device pending FDA approval can contact CMS about possible coverage before FDA makes its decision. It also noted, however, that FDA approval alone does not entitle a device to coverage.

The notice, published in the September 26, 2003 Federal Register [68 FR: 55634-55641], also covers a number of procedural issues. It took effect on October 27, 2003. It in part implements the Medicare, Medicaid, and State Children's Health Insurance Program Benefits Improvement and Protection Act of 2000.

The document defines what constitutes a complete, formal initial request for a national coverage decision, and differentiates the process from a request for reconsideration. It also describes the ways in which an initial request can be generated. The primary path can be initiated by any party, whether manufacturer, healthcare provider, supplier, or patient. This path generally takes 90 days but can take longer if questions arise or clarifications are needed. 

A second path is open to “aggrieved parties” who are in need of the products or services in question. This path ensures a national coverage decision, and a decision memorandum will be issued in 90 days. The actual effective coverage date could be later if claims processing systems must be changed. 

The 90-day clock begins only when the agency has accepted a complete, formal request. The acceptance will be posted to the CMS Web site, and the public has 30 days to comment on it. CMS will respond to the comments in the decision memorandum. 

The notice also explains what firms must do to trigger the reconsideration process. A request will be considered if it offers new scientific or medical evidence, or argues that the initial decision misinterpreted the evidence. 

The document also outlines the role of the Medical Coverage Advisory Committee (MCAC). It provides independent, expert advice on some of the tougher coverage decisions. CMS states in the notice that it will involve MCAC when a coverage issue is the subject of significant scientific or medical controversy or of public controversy, or when it could have a major impact on those aged 65 and over.

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