Press Releases

CMS ISSUES TWO FINAL GUIDANCE DOCUMENTS RELATED TO NATIONAL COVERAGE PROCESS

The Centers for Medicare & Medicaid Services (CMS) today issued the first two in a series of final guidance documents about Medicare’s national coverage determinations (NCD) process as part of its goal of continuing to make the process more open, transparent, and understandable.

“These guidance documents will provide valuable information about processes 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 B. McClellan, MD, PhD.

“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,”  Dr. McClellan said.

In March 2005, CMS issued draft versions of three guidance documents with a 60-day public comment period, and encouraged all interested stakeholders to comment on these drafts.  CMS received over 20 comments from various stakeholders, and incorporated those comments as appropriate.  We believe that the final guidance documents balance the interests represented by the public comments, while maintaining an objective NCD process.

The two guidance documents released today detail certain steps in the NCD process concerning CMS’ determinations of whether an item or service is reasonable and necessary, and explain the factors CMS considers when: 1) initiating a Medicare NCD; and 2) determining whether to commission an external health technology assessment (HTA) to evaluate a new health care technology.

CMS plans to issue a final draft of a third guidance document to explain the factors the Agency considers when  referring issues to the Medicare Coverage Advisory Committee (MCAC) for independent, expert advice and public input on specific clinical topics.

While the documents outline major components of the NCD process, they continue to be non-binding documents intended to communicate CMS’ current thinking on these topics.  The final versions of these guidance documents are posted online at http://www.cms.hhs.gov/MedicareCoverageGuideDocs/.