BALTIMORE--CMS issued guidance documents last week that break down Medicare's national coverage determinations process into detailed steps.

According to the agency, the guidance was published as part of its goal of "continuing to make the process more open, transparent and understandable."

NCDs may be opened internally as a result of clinical advances for technologies in existence and new or modified items or services, CMS said. Formal requests can also come from external parties such as a provider, manufacturer or beneficiaries who are "aggrieved parties."

Last year, three guidance document drafts were issued: one on opening an NCD, one on commissioning an external technology assessment, and a third on referring to the Medicare Coverage Advisory Council. The first two final documents were released Tuesday. They outline how CMS determines whether an item or service is reasonable and necessary and the factors CMS considers when initiating a Medicare NCD, and explain how the agency determines whether an external assessment is needed to evaluate a new technology.

CMS plans to issue a final draft of the third document at a later date to explain what the agency considers when referring issues to the MCAC for expert advice and public input on specific clinical topics.

"These guidance documents will provide valuable information about the process we follow in making national Medicare coverage decisions to those who come to us with national coverage requests, as well as to other stakeholders," said CMS Administrator Mark McClellan.

"We hope that as the various stakeholders gain the information they need to become better acquainted with our processes, we will be better able to engage the public in meaningful discussions that will result in improving access to critical medical technologies for all Medicare beneficiaries."

The final versions of these guidance documents are posted online at www.cms.hhs.gov/MedicareCoverageGuideDocs.