(1) Data Provided to ASM Participants (a) Legal Authority To Share Beneficiary-Identifiable Data and Applicability to ASM Data Sharing Processes As discussed in the CY 2026 PFS proposed rule (90 FR 32619), we believe that an ASM participant may need access to certain Medicare beneficiary-identifiable data for the purposes of evaluating its performance, conducting quality assessment and improvement activities, conducting population-based activities relating to improving health or reducing health care costs, or conducting other health care operations listed in the first or second paragraph of the definition of health care operations under the HIPAA Privacy Rule, 45 CFR 164.501

Key Takeaways If youre short on time, heres a quick summary to understand the key differences between 503As and 503Bs right away: 503A compounding pharmacies compound medications according to individual patient prescriptions, which may be intended for either at-home use or administration in a healthcare setting, while 503B outsourcing facilities compound drugs in larger batch sizes under cGMP with or without patient-specific prescriptions to be distributed (generally) to healthcare facilities for office use
Elo IT, Luck A, Stokes AC, Hempstead K, Xie W, Preston SH
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