![]() ![]() We are specifically interested in public comments on the evidence we cited in this decision, comments containing any new evidence that has not been considered, and comments on whether a study could be developed that would support coverage with evidence development (CED), which would only cover gender reassignment surgery for beneficiaries who choose to participate in a clinical study. ![]() ![]() We are requesting public comments on this proposed decision memorandum pursuant to section 1862(l)(3)(a) of the Act. Based on the gaps identified in the clinical evidence, these studies should focus on which patients are most likely to achieve improved health outcomes with gender reassignment surgery, which types of surgery are most appropriate, and what types of physician criteria and care setting(s) are needed to ensure that patients achieve improved health outcomes. While we are not issuing a NCD, CMS encourages robust clinical studies that will fill the evidence gaps and help inform the answer to the question posed in this proposed decision memorandum. ![]() Subject: Proposed Decision Memorandum on Gender Reassignment Surgery for Medicare Beneficiaries with Gender Dysphoria We are specifically interested in public comments on the evidence we cited in this decision, comments containing any new evidence that has not been considered, and comments on whether a study could be developed that would support coverage with evidence development (CED), which would only cover gender reassignment surgery for beneficiaries who choose to participate in a clinical study.Äeputy Director, Coverage and Analysis Group Of physician criteria and care setting(s) are needed to ensure that patients achieve improved health outcomes. Based on the gaps identified in the clinical evidence, these studies should focus on which patients are most likely to achieve improved health outcomes with gender reassignment surgery, which types of surgery are most appropriate, and what types In the absence of a NCD, initial coverage determinations under section 1862(a)(1)(A) of the Social Security Act (the Act) and any other relevant statutory requirements will be made by the local Medicare Administrative Contractors (MACs) on an individual claim basis. The low number of clinical studies specifically about Medicare beneficiaries’ health outcomes for gender reassignment surgery and small sample sizes inhibited our ability to create clinical appropriateness criteria for cohorts of Medicare beneficiaries. Our review of the clinical evidence for gender reassignment surgery was inconclusive for the Medicare population at large. The Centers for Medicare & Medicaid Services (CMS) proposes to continue this practice and not issue a National Coverage Determination (NCD) at this time on gender reassignment surgery for Medicare beneficiaries with gender dysphoria. Currently, the local Medicare Administrative Contractors (MACs) determine coverage of gender reassignment surgery on an individual claim basis. ![]()
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