Press release



The Centers for Medicare & Medicaid Services (CMS) today issued the first three drafts in a series of guidance documents to improve the Medicare National Coverage Determination (NCD) process.


“This is the continuation of our ongoing efforts to make the Medicare coverage decision process more transparent, responsive, and effective,” said CMS Administrator Mark B. McClellan, M.D., Ph.D.  “We want comments on these draft guidance documents to help us make sure that Medicare beneficiaries get prompt access to technologies that can improve their health, and that technology developers have a clear understanding of our coverage process.”


The draft guidance documents, posted today on, are the first in a series of guidance documents that will be made pursuant to section 731 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA).


These draft guidances detail certain steps in the process CMS uses in determining whether an item or service is reasonable and necessary for coverage as a Medicare benefit. They explain the factors CMS considers when deciding to open an issue for Medicare national coverage; determining when to commission an external health technology assessment to evaluate the risks and benefits of a health care technology; and referring issues to the Medicare Coverage Advisory Committee for independent, expert advice and public input on specific clinical topics.


CMS is encouraging stakeholders to comment on these drafts during the 60-day comment period that begins today.


CMS held an open door forum in the fall of 2004 to begin discussions on developing guidance documents under the Medicare program.  Another forum on Feb. 14, 2005, featured discussion of possible guidance concerning Medicare coverage decisions associated with data collection requirements.  CMS also will host an open door forum on March 10, 2005, to obtain further input.  CMS plans to hold additional open door forums and solicit additional public input as needed.


CMS is also requesting assistance in prioritizing other topics for additional guidance documents.  Other guidance documents under development include guidance on evidence development through coverage.


“Over the past five years, CMS has made important improvements to the national coverage process, including establishment of the Medicare Coverage Advisory Committee, publication of detailed decision memos to describe the scientific basis for coverage decisions, and significantly increasing access to CMS coverage staff,” said Sean R. Tunis, M.D., CMS’ chief medical officer.  “These draft guidance documents demonstrate the agency’s commitment to continually improve the transparency and predictability of the coverage process.”


Final guidance documents should be completed within 90 days after the close of the initial 60-day comment period.


McClellan also announced today that the CMS Website has been expanded to provide an Internet home for the Council on Technology and Innovation (CTI). 


The CTI is comprised of senior level CMS leaders and experts on clinical, coverage and payment issues. The Council’s mission is to coordinate policy development within CMS to ensure faster and more efficient coverage and payment of new medical technologies and to support improved methods for developing practical information about the clinical benefits of new medical technologies.


The council’s new Website,, is designed to keep providers and other stakeholders, interested in Medicare coverage, coding and payment, apprised of council activities through up-to-date information and a CTI mailing list.


In addition to information about the guidance documents CMS is developing, the CTI Website also contains information on upcoming open door forums, town halls and other meetings related to CTI activities, as well as updates on other important CTI initiatives. The CTI Website, along with special open door forums and other public announcements are among the many ways that the CTI encourages public participation in technology policy development.