Medicare moves to improve NCD process

March 14, 2005 WASHINGTON -- The Centers for Medicare & Medicaid Services last week 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 in an agency press release. "We want comments on these draft guidance documents to help us make sure that Medicare beneficiaries get prompt access to technologies that can improve their health, and that technology developers have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." These draft guidance documents detail certain steps in the process CMS uses in determining whether an item or service is reasonable and necessary for coverage as a Medicare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 began March 9. CMS held an open door forum in the fall of 2004 to begin discussions on developing guidance documents under the Medicare program and another forum on Feb. 14 featured discussion of possible guidance concerning Medicare coverage decisions associated with data collection requirements. CMS also hosted an open door forum on March 10, 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. Final guidance documents should be completed within 90 days after the close of the initial 60-day comment period.