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We continue to believe that the use of ASP information for OPPS payment could provide an opportunity to improve payment accuracy for separately payable diagnostic radiopharmaceuticals by applying an established methodology that has already been successfully implemented under the OPPS for other separately payable drugs and biologicals, as well as for therapeutic radiopharmaceuticals

Analytical testing methods provide definitive degradation assessment but require specialized equipment

Virtual and Physical Separation Requirements: Data and workload separation requirements have also seen a revision, with this section clarified as Impact Level Separation Requirements vs the former Cloud Deployment Model Considerations/Separation Requirements. Importantly, the physical separation compute and storage for isolated IL5 workloads in IL4 authorized CSOs is no longer documented as acceptable, which was previously documented under Impact Level 5 Separation in an Impact Level 4 CSO. Firm requirements for physical separation from non-DoD/non-federal government tenants at IL5, and strong virtual isolation at IL4, remains in-scope in the latest SRG

There is no FDA-approved indication, dose, or population