April 2025
IN THIS ISSUE
The Alliance
Insight Series
The Alliance insight series offers critical resources for stakeholders across the donation and transplantation continuum. For each topic, you can find related action items, tools, and references.
The Alliance Insight Series
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A Note About Content
Some legacy resources on this website may refer to UNOS in place of the OPTN, reflecting common usage at the time of publication when the two were often used interchangeably. In recent years, significant work has gone into distinguishing these as separate entities: the OPTN is the nationwide organ transplant network established by federal law, while UNOS is one of several organizations currently under contract to support OPTN operations. We’ve preserved these resources as originally published, but recommend referring to current terminology for the most accurate understanding of each organization’s role.
APRIL 2025
From its inception in 1986 through continuous refinement in 2024, CMS’s oversight of transplant programs is the federal government’s earnest attempt at ensuring high standards of care. While CMS oversight has undoubtedly improved transplant program accountability and patient safety, many transplant centers still struggle with the balance between regulatory compliance and real-world clinical decision-making.
The 2024 updates reflect progress, but transplant leaders continue to advocate for a more streamlined, patient-centered approach that reduces administrative burdens while maintaining high standards of care. The Conditions of Participation (CoPs) and SOM Appendix X serve as an essential tool for transplant programs to be successful in meeting these standards.
1986
LAYING THE REGULATORY FOUNDATION: Early Oversight of Transplant Programs
The Federal Government Steps In
- Following growing concerns over program variability, inconsistent patient outcomes, there was a call for national oversight in the rapidly advancing field of transplantation.
- The Omnibus Budget Reconciliation Act (OBRA) of 1986 mandated that organ transplant programs receiving Medicare and Medicaid funding meet federal quality, safety, and performance standards.
- The Health Care Financing Administration (HCFA, now CMS) was tasked with developing regulatory standards.
- Surveys were conducted by State Survey Agencies under CMS oversight.
- Programs previously varied greatly in eligibility criteria, outcomes, and quality standards.
Impact on Transplant Programs:
- Established a basic regulatory structure and national benchmarks.
- Lack of implementation detail created compliance uncertainty.
- New reporting burdens without standardized metrics.
2007
ESTABLISHING COMPREHENSIVE NATIONAL STANDARDS
CMS Codifies Conditions of Participation (CoPs)
- Regulation introduced to address inconsistent enforcement and disparate outcomes.
- Formalized eligibility, performance measurement, patient safety protocols, and quality improvement requirements.
Key Tenets:
- CMS Certification required for Medicare and Medicaid reimbursement.
- Defined the conditions of transplant program CoPs.
- Programs must track data and implement corrective actions as needed.
Impact on Transplant Programs:
- Created structure and national oversight consistency.
- Programs risk losing certification due to poor results.
- Significant new administrative burden.
2008
ENHANCING SURVEY AND COMPLIANCE PROCESSES
- Appendix X added to the State Operations Manual (SOM) to provide “how to” guidance.
- Interpretive guidelines help ensure consistent evaluations.
- Processes defined for scoring compliance with CoPs.
Impact:
- More consistent surveys, less subjectivity.
- Labor-intensive site visits place demands on staff.
2010–2015
INCREASED SCRUTINY & LIVING DONOR PROTECTIONS
- Focus shifted to prevention rather than punishment.
- CMS initiated targeted surveys and piloted third-party surveyor contracts.
- Living donor protections strengthened.
- QAPI refinements introduced.
Impact:
- Enhanced living donor safety, fewer liability risks.
- Increased administrative burden balancing multiple oversight bodies (CMS, OPTN, IRB).
2017
RESHAPING MODERN OVERSIGHT & FLEXIBILITY IN REGULATIONS
- Revised SOM Appendix X aligned CMS and OPTN guidance.
- Standardized surveyor processes to reduce variability.
- More flexibility in corrective actions.
Impact:
- Improved data clarity and reduced ambiguity.
- Surveyors and programs had clearer expectations.
2019–2021
ALIGNING FOR GREATER FLEXIBILITY IN QUALITY STANDARDS
- CMS signaled flexibility in how programs meet requirements.
- Encouraged programs to use their own data to identify quality gaps.
- Stronger emphasis on QAPI and multidisciplinary team decision-making.
Impact:
- Programs with complex cases felt less penalized.
- State agencies took on more survey responsibility.
December 2024
THE LATEST UPDATES & THE FUTURE OF CMS OVERSIGHT
- CMS updates to Appendix X reflect input from audits, patient safety, and transplant teams.
- Standardized surveyor training and streamlined processes.
- Real-time data reporting and deeper analysis.
- Focus on multidisciplinary collaboration and QAPI accountability.
Impact:
- Improved transparency and clarity.
- Patient safety enhancements for living and high-risk donors.
- Continued burden of administrative documentation remains a challenge.
Survey Reports | Existing Elements: | ADDED Elements |
|---|---|---|
| Active waiting list |
| Total number of individuals on the waiting list |
| Waitlist Removals (non-death) past 12 months |
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| Waitlist Removals due to death or transplant (New Report) |
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| Evaluation Declines past 12 months |
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| Transplanted last 18 months |
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| Living Donors evaluated past 12 months |
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| Currently admitted transplant and living donor patients |
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| Follow-up visits for post-transplant & post-donation (New Report) | ||
| Declined Organ Offers past 18 months (New Report) | List and number of declined offers with decline code |
Survey Reports | What are surveyors looking for? |
|---|---|
Schedule for all multidisciplinary team meetings *including rounding |
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Schedule of Selection Committee meetings |
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Schedule of all QAPI meetings |
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Additional opening survey required documentatioN | |
|---|---|
Organizational chart | Incorporates how the transplant center fits into overall hospital organization |
| Schedule of Selection Committee meetings | Incorporates how the transplant center fits into overall hospital organization |
| Contracts | Incorporates transplant center into hospital organization. Include, but not limited to:
|
| Training schedule for personnel (New Documentation) |
|
| On-call schedule for transplant surgeons and physicians (past 30 days) | |
Quality related documentation | |
|---|---|
Adverse Events for the past 24 months (New extended time frame) | |
Adverse Event/ Occurrence Policy | |
Quality Assessment and Performance Improvement (QAPI) Plan | |
Hospital QAPI Plan | |
QAPI reports, records, minutes |
POLICIES | New / Emphasized requirements: |
|---|---|
Patient Selection Criteria for transplant and living donors | |
ABO Verification Policy Transplant Recipients & Living Donors | Include associated blank forms |
Waiting list management policy | Including patient notification |
Psychosocial Evaluation Policy for transplant candidates and living donors (new policy requirement) | Update policies to include the following:
The method of communicating the psychosocial evaluation findings into the selection process. |
Patient Management Policies for transplant and Discharge |
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Living Donor Management for Pre-donation, donation and discharge phases |
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| Informed Consent policy for transplant recipients and living donors | Policy needs to be updated to include the following:
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| Communication between patients and dialysis centers | |
| Availability of transplant team |
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| Potential unavailability at centers with single surgeon/physician | |
| Emergency Management Preparedness | |
Patient Education: all material used pre and post-transplant and pre and post living donation |
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Additional Regulations for Consideration | |
|---|---|
A request for nutritional and/or social services can also be made by the patient, family member(s)/caretakers, and/or the patient’s multidisciplinary team. |
Living Donor Services Under contract arrangement | |
|---|---|
Have written evidence of a contract or agreement with the living donor transplant program(s). This may be a specific contract or agreement between two hospitals or programs, or it may include participation in a transplant registry for paired donation of living donors and recipients. | |
Have a copy of the Medicare-approval letter for the living donor transplant program with which it has a contract or agreement, or have documented evidence that the CMS website listed below was reviewed prior to accepting the living donor organ to ensure that the program was a Medicare-approved program. | |
Donor record information requirements:
| |
As part of the Quality Assessment and Performance Improvement (QAPI) requirement, ensure that there is a feedback system between the recipient and donor hospital to address any adverse events that occur in the donor or the recipient for a specific donation or transplant. |
A SPECIAL THANKS TO THE TRANSPLANT QUALITY CORNER WORKGROUP
FEEDBACK
If there is content you feel that should be added or was lacking, we would like to hear from you. Positive feedback on what is working for you, is also welcomed. Thank you for taking the time to provide us with your feedback.