CMS Issues Guidance Documents on NCD Process

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.