Dynamic List Information
Dynamic List Data
Title
Outcome Requirements for Initial Transplant Program Approval
Memo #
QSO-25-04-Transplant
Posting Date
2024-10-10
Fiscal Year
2025
Title
Memorandum Summary
• Outcome requirements: The transplant program Conditions of Participation (CoPs) for initial approval at 42 C.F.R. §488.61 require compliance with all data submission, clinical experience, and outcome requirements under §482.80, with limited exceptions.
• Data delay: Since the outcome requirements §482.80(c) must include one-year post transplant data, there may be a delay in the availability of the outcomes data at the time of the applicant program’s request for initial Medicare approval.
• Data availability: Centers for Medicare & Medicaid Services (CMS) and State Survey Agencies (SA) must confirm the availability of outcomes data before initiating an onsite survey. If the outcomes data is not available, an onsite survey cannot be initiated and the SA should notify the prospective provider that the initial survey will occur once the data becomes available.
• Outcome requirements: The transplant program Conditions of Participation (CoPs) for initial approval at 42 C.F.R. §488.61 require compliance with all data submission, clinical experience, and outcome requirements under §482.80, with limited exceptions.
• Data delay: Since the outcome requirements §482.80(c) must include one-year post transplant data, there may be a delay in the availability of the outcomes data at the time of the applicant program’s request for initial Medicare approval.
• Data availability: Centers for Medicare & Medicaid Services (CMS) and State Survey Agencies (SA) must confirm the availability of outcomes data before initiating an onsite survey. If the outcomes data is not available, an onsite survey cannot be initiated and the SA should notify the prospective provider that the initial survey will occur once the data becomes available.