CMS Issues Draft Guidance for NCD Process
The best way for drug and device manufacturers to receive the fastest possible coverage decisions from the Centers for Medicare & Medicaid Services (CMS) is to submit all relevant information on their products during the initial request for a Medicare national coverage determination (NCD), the agency states in a new draft guidance.
Although NCD requestors are encouraged to provide additional information and engage in dialogue to clarify issues that arise during the development of an NCD, the process is likely to be completed in the most timely manner when all relevant data is provided to the CMS up front, the agency said.
That recommendation is one of several contained in a draft guidance titled, "Factors CMS Considers in Opening a National Coverage Determination." The document is one of three draft guidances recently released by CMS as part of a broad effort to improve the Medicare NCD process. The draft guidances are the first in a series of guidance documents the CMS plans to release pursuant to Section 731 of the Medicare Prescription Drug Improvement and Modernization Act of 2003.
To view the guidances, go to https://www.cms.hhs.gov/coverage/guidance.asp (https://www.cms.hhs.gov/coverage/guidance.asp).
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