Why So Many Donor Organs Are Lost and How CMS Plans to Fix the System
The Centers for Medicare and Medicaid Services (CMS) has proposed a new rule to revise how Organ Procurement Organizations (OPOs) are overseen in the United States. This is not a minor administrative update. It targets long-standing weaknesses in performance accountability, quality systems, and consistency across the organ procurement network.
At its core, the proposal is an attempt to fix a structural problem in the transplant supply chain: wide variation in OPO performance, preventable loss of usable organs, and uneven safety and quality practices across regions.
CMS is signaling that the current oversight model is no longer sufficient for a system that supports more than 40,000 transplants a year and affects hundreds of thousands of patients on waiting lists.
The problem CMS is trying to solve
Multiple federal reviews and investigative reports over the past decade have documented large differences in how OPOs perform. Some recover and place far more organs per potential donor than others. Some consistently underperform. Some struggle with quality and process controls.
The problem, in numbers:
~20% of recovered organs are never used (over 9,000 in 2022).
~1 in 5 organs (especially kidneys) recovered are discarded.
100,000+ people are waiting for a transplant.
Main causes: system failures, not just medical reasons.
These are not abstract metrics. Lower recovery and placement rates translate directly into:
Fewer organs available for transplant
Higher discard rates of potentially usable organs
Longer waiting times for patients
Greater regional inequity in access to transplantation
The current regulatory framework has not reliably corrected these gaps. CMS certifies and oversees OPOs, but enforcement tools, performance benchmarks, and quality requirements have lagged behind the realities of modern transplant medicine.
The proposed rule is an attempt to modernize that framework.
What CMS is proposing, in practical terms
The rule focuses on three operational pillars:
Clear performance scorecards: CMS would judge each Organ Procurement Organization (OPO) using specific, comparable metrics, such as how many donors are identified, how many organs are recovered, and how many are actually transplanted. This makes it harder to hide behind paperwork or vague process claims.
Real consequences for low performers: OPOs that repeatedly miss these benchmarks could face penalties, loss of certification, or replacement. In practice, this means poor performance would no longer be allowed to continue year after year without risk.
Mandatory quality systems, not optional ones: OPOs would be required to run formal quality programs that track delays, missed donors, organ damage, transport problems, and failed handoffs. They would have to document problems, fix them, and show proof of improvement.
Process checks across the entire chain: The rule targets the points where organs are often lost, such as late donor referral, slow evaluation, poor coordination with hospitals, and breakdowns in transport or matching. OPOs would be expected to standardize and monitor these steps instead of relying on local habits.
Pressure to reduce “default discards”: By tightening oversight and performance tracking, CMS is pushing OPOs to improve how organs are evaluated and offered, including medically complex organs, so fewer are dropped from the system before transplant centers even see them.
Data tied to enforcement: Performance data would no longer be just for reports. It would be directly tied to whether an OPO is allowed to keep operating, creating a financial and operational incentive to fix weak processes instead of tolerating them.
What this changes in the transplant system
If finalized and enforced as intended, this rule could shift incentives and behavior across the procurement network in several ways:
More pressure on consistently low-performing OPOs to improve processes, staffing, and coordination
Greater standardization of quality systems across regions
More attention to organ utilization pathways, not just recovery counts
Closer alignment between oversight, performance data, and enforcement
In practical terms, this is about tightening the weakest links in the organ supply chain. The goal is not simply to increase numbers on paper, but to move more usable organs safely from donor to recipient.
What this does and does not mean for patients
This proposal does not change how transplant centers decide whether an organ is appropriate for a specific patient. Clinical judgment, risk assessment, and patient consent remain central.
What it does target is the upstream system that determines:
Whether potential donors are identified
Whether organs are recovered efficiently and safely
Whether recoverable organs are lost due to process failures or weak coordination
In other words, this is a supply-side reform. Its success will be measured not by rhetoric, but by whether fewer viable organs are lost before they ever reach a transplant offer.
For clinicians and transplant programs
The proposed revisions to the OPO Conditions for Coverage signal tighter regulatory scrutiny of procurement operations, quality systems, and performance management.
Programs should expect:
Increased emphasis on documented quality assurance and process control
Greater visibility of OPO performance variation in regulatory oversight
More direct linkage between performance metrics and compliance consequences
Continued policy pressure to improve utilization of medically complex organs without compromising safety
While the rule targets OPOs, its downstream effects will likely be felt across transplant center operations, particularly in coordination, logistics, and organ acceptance workflows.
Why this is a meaningful policy shift
For years, transplant policy has struggled with a basic contradiction: demand for organs continues to rise, yet significant numbers of potentially usable organs never reach transplantation due to system inefficiencies, inconsistent performance, and uneven oversight.
This CMS proposal is an explicit attempt to treat organ procurement as critical national health infrastructure rather than a loosely regulated regional service network.
Whether it succeeds will depend on three things:
How strong the final performance standards and enforcement mechanisms are
Whether CMS follows through on consistent oversight
Whether improvements show up in utilization and safety data, not just compliance reports
The rule itself will not fix the organ shortage. But it does aim to reduce preventable losses inside the system that exists today.
What to watch next
This is a proposed rule, not a final one. The next phases to watch:
Public and stakeholder comment and how CMS responds
The final performance and quality benchmarks adopted
How enforcement is applied to persistently underperforming OPOs
Whether organ utilization and discard rates actually improve over time
The real test will be simple and measurable: does the system deliver more usable organs, more reliably, and more safely to patients who need them?
That is the standard this policy should be held to.
Summary
Centers for Medicare & Medicaid Services: CMS Proposes Rule to Strengthen Oversight of Organ Procurement Organizations and Protect Patients
Associated Press / ABC News: Medicare proposes new transplant system rules that might spur use of less-than-perfect organs
MedicalXpress / HealthDay: New federal plan aims to use more donor organs, improve transplant safety
Rheumatology Advisor / EMPR (health news outlets): New federal plan aims to use more donor organs, improve transplant safety
Federal Register (U.S. Government rulemaking): Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage Revisions to CMS-3409-P Proposed Rule