When we make an NCD, we provide a clear statement of the basis for the NCD as well as responses to the comments received from the public. The NCD process also considers public comments. The public is afforded the opportunity to comment on a proposed determination as set forth in section 1862(l). NCDs concerning whether a particular item or service is reasonable and necessary under section 1862(a)(1)(A) are based on information including clinical experience, and medical, technical, and scientific evidence. The Centers for Medicare & Medicaid Services' (CMS) procedures for issuing guidance documents under this authority are set forth in 69 Fed. Section 1862(l)(1) of the Social Security Act (the Act) requires that the Secretary of Health and Human Services (the Secretary) make available to the public theįactors that are considered in making national coverage determinations (NCDs) of whether an item or service is reasonable and necessary. Importance of Control Groups and Blinding in CED Studies Clinical Study Standards for CED under Section 1862(a)(1)(E) Principles governing the application of CED: Purpose of this Proposed Guidance Document Proposed Guidance Document Issued on JContents
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