Looks like being first ( rare) may be the delay. See reference to Car T reimbursement
Reg
With respect to Medicare Parts A and B, most coverage determinations are made by MACs on a case-by-case basis or through LCDs to determine whether a given product will be covered in the MAC’s jurisdiction. CMS also can issue NCDs to determine coverage of a drug product nationwide; while NCDs for drugs are rare, recent notable examples include the NCD for CAR-T therapies and the NCD with coverage with evidence development for monoclonal antibodies that target amyloid (or plaque) for the treatment of Alzheimer’s disease.[lxxv]
https://www.globallegalinsights.com/practice-areas/pricing-reimbursement-laws-and-regulations/usa/
Ann: Ryoncil Commercial Launch Update and Product Pipeline, page-210
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