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Series: Nationwide Audits of Organ Procurement Organizations and Certified Transplant Centers

Announced on  | Last Modified on  | Series Number: SRS-A-25-031
Status
Active
Agency
Centers for Medicare and Medicaid Services

OBJECTIVE

Organ Procurement Organizations (OPOs) are not-for-profit organizations that perform or coordinate the procurement, preservation, and transportation of organs to hospitals for transplantation into patients who are on a waiting list to receive a transplant. Certified Transplant Centers (CTCs) are components within transplant hospitals that provide transplantation of particular types of organs. CTCs are reimbursed by Medicare for certain costs associated with the acquisition of organs from OPOs or other CTCs for transplants involving Medicare patients. Federal regulations (42 CFR part 486, subpart G) include Medicare conditions for coverage for OPOs, and other Federal statutes, regulations, and guidance specify Medicare requirements for the acquisition of organs. Prior OIG audits determined that OPOs did not comply with Medicare requirements for reporting overhead costs, administrative and general costs, and organ statistics. We will determine whether costs reported by OPOs and CTCs were allowable, reasonable, and according to Medicare requirements, and whether OPOs met required process performance and outcome measures

There are 5 projects in this series.

Project titles will remain unpublished until projects are complete and reports are posted.

ACTIVE PROJECTS IN THIS SERIES (4)

Project A-07-24-00643 • Announced on May 3, 2024

Project A-09-24-03009 • Announced on Aug 6, 2024

Project A-09-24-03010 • Announced on Aug 8, 2024

Project OAS-25-07-123 • Announced on Jun 18, 2025

COMPLETED PROJECTS IN THIS SERIES (1)

Review of Medicare Usable Organs at Certified Transplant Centers

Project OAS-25-07-124 • Completed on September 1, 2026

TIMELINE

  • May 3, 2024
    Series Number SRS-A-25-031 Assigned
  • May 3, 2024
    Project Announced

    Project A-07-24-00643

  • August 6, 2024
    Project Announced

    Project A-09-24-03009

  • August 8, 2024
    Project Announced

    Project A-09-24-03010

  • June 18, 2025
    Projects Announced

    Project OAS-25-07-123

  • Review of Medicare Usable Organs at Certified Transplant Centers - OAS-25-07-124

  • September 1, 2026
    Project Complete - OAS-25-07-124

    Review of Medicare Usable Organs at Certified Transplant Centers complete. This audit resulted in 2 recommendations.

  • Today
    4 Audits In-Progress
  • Est FY2027
    Estimated Fiscal Year for Series Completion

1 REPORT PUBLISHED

Conflicting CMS Guidance and Federal Statutory Requirements Cost Medicare $380 Million Over a 6-Year Period for Organs Not Transplanted Into Medicare Enrollees (OAS-25-07-124)

Medicare did not, in some instances, reimburse CTCs for organ acquisition costs for organs that CTCs reported as Medicare usable organs in accordance with Federal statutory and regulatory requirements.

  • Of the 180 reported Medicare usable organs in our sample, Medicare reimbursed CTCs a total of $2.8 million for 43 organs that were not used in Medicare-covered transplants and 12 organs that were not transplanted at all. Based on Federal statutory requirements, Medicare should not have reimbursed the costs for these 55 organs. CMS guidance conflicts with Federal statutory requirements.
  • On the basis of our sample results, we estimated that Medicare paid CTCs about $380 million for the costs of acquiring organs that were not used in Medicare-covered transplants during our 6-year audit period.

In addition, two CTCs could not provide any documentation to support a total of five organs, totaling $154,210 in unallowable Medicare reimbursement, that they reported as Medicare usable organs.

26-A-07-095.01 to CMS - Open Unimplemented
Update expected on 02/28/2027
We recommend that CMS direct the relevant MAC to recover $154,210 in Medicare reimbursement paid to two CTCs that could not provide documentation to support the numbers of Medicare usable organs that they reported on their Medicare cost reports.

26-A-07-095.02 to CMS - Open Unimplemented
Update expected on 02/28/2027
We recommend that CMS revise Medicare guidance to CTCs to align with Federal statutory requirements to count and report as Medicare usable organs only those organs transplanted into Medicare enrollees, which could have saved Medicare $379,895,793 during our audit period.

View in Recommendation Tracker
Work Plan Type
Office of Audit Services
HHS Agencies
Centers for Medicare and Medicaid Services
Issue Areas
Hospitals Financial Stewardship
Target Groups
-
Financial Groups
Medicare A