Final guidance clarifying the factors leading CMS to open a national Medicare coverage decision, released April 11, stops short of outlining precise threshold criteria for initiating assessments internally, as had been requested by device manufacturers.

Consistent with a draft document published last year, CMS writes that it will initiate a national coverage determination (NCD) if "evidence suggests that local variation is not warranted" (¹ [A#01310110018], p. 18). However, the final guidance fails to specifically address industry concerns about the proliferation of internally generated requests.

AdvaMed and the Medical Device Manufacturer's Association (MDMA) were among the more than 20 stakeholders who commented on the draft. The trade groups said internally generated requests could result in premature national assessments and undermine the local coverage process, which facilitates swift adoption of a company's technology (² Also see "AdvaMed, MDMA Stress Local Coverage Preservation In Guidance Comments" - Medtech Insight, 2 May, 2005., p. 30).

Whereas a positive NCD could be a windfall for a medical technology company, opening the NCD process before sufficient evidence has been collected leaves a product vulnerable to a national non-coverage determination, which wipes out any previous regional Medicare coverage.

The final NCD guidance clarifies that CMS "will provide advance notice to the public regarding the potential topics that we are considering," a stipulation recommended by both AdvaMed and MDMA. The agency also removed language pertaining to "safety and effectiveness" in response to stakeholder comments that such issues should remain under FDA's jurisdiction.

Also on April 11, CMS released a finalized version of a guidance on how the agency considers whether to consult with a health technology assessment from an external group, which was largely unchanged from the draft version issued in March 2005.

The two guidances are part of a CMS effort to makes its NCD process more transparent. The agency also plans to issue a final version of a third guidance document describing the agency's considerations for referring issues to the Medicare Coverage Advisory Committee.

- Katherine Thomas

CMS Issues Two Of Three Final Guidances On The National Coverage Process

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