The Alliance submitted comments to CMS' Proposed Guidance Document: Study Protocols That Use Real-world Data (RWD) urging that use of RWD for real-world evidence (RWE) be extended to all coverage determinations, not just to the national coverage determination (NCD) coverage with evidence development (CED) process as proposed. "Using RWE only for NCDs with CED is rather limiting as there are very few NCDs based on CED. If the Agency is permitting RWE to be used for coverage purposes, the use should be extended to all coverage determinations," the Alliance advocated to CMS, submitting the recommendation that "any coverage policy should consider RWE as an adjunct to Level 1/Level 2 evidence when determining product coverage since it aligns with the Congressional intent of the 21st Century Cures Act in 2016 encouraging the use and acceptance of RWE. Therefore any guidance offered in terms of appropriate evidentiary standards including the use of RWE should apply not only to NCDs based on CED or NCDs in general but also to Local Coverage Determinations (LCDs)."

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