How CMS's final organ procurement rule shapes the first round of decertifications and competitions

Most of the country’s organ donation territories are about to be put up for competition. The United States is divided into 55 donation service areas (DSAs), and in each one a single organ procurement organization (OPO) holds the federal designation to recover organs from deceased donors. The Centers for Medicare & Medicaid Services (CMS) now estimates that 35 of those areas will be opened to competing OPOs at the end of the first recertification cycle judged under its 2020 performance standards. In 14 of them the incumbent fell below the minimum standard. In the other 21 it cleared the minimum but did not rank among the top performers.

On October 30, 2026, CMS released the final rule that governs how that process plays out (CMS-3409-F). It was published in the Federal Register on November 3 and takes effect on January 4, 2027. Apart from one change in how transplants are counted, the rule leaves the two outcome measures and the three-tier ranking alone. What it changes comes after a ranking is assigned. An OPO serving more than one territory can now lose one without losing its certification. A mid-ranked OPO that is outcompeted keeps its certification but not its territory. Decertification appeals must move much faster. CMS also gains a defined basis for acting immediately on safety grounds, and it has removed the regulatory bar to certifying organizations that are not already OPOs.

Most of the evidence comes from the rule text and its regulatory impact analysis, which hold the most current official tier counts.

Key takeaways

• The yardstick is essentially unchanged. The consequences are now spelled out. CMS’s impact analysis counts 14 tier 3 and 21 tier 2 service areas in the final assessment period, which puts 35 of 55 DSAs in line for competition once appeals are resolved.
• Tier status now belongs to a service area, not an organization. An OPO serving several DSAs loses only the ones that fall to tier 3 and stays certified if any other DSA is in tier 1 or tier 2. CMS expects as many as 14 OPOs to end up serving more than one territory.
• A tier 2 OPO can be recertified and still lose its territory. Losing a competition is treated as a nonrenewal, not a decertification, so there is no administrative appeal. A federal court ruled in September that tier 2 OPOs can challenge the framework directly in federal court.
• Decertification appeals are compressed. An OPO now has 15 calendar days, down from 40 business days, to request a hearing. The CMS Administrator also gains discretionary review of hearing officer decisions.
• Several proposals did not survive comment. CMS dropped its definition of “medically complex” donors and a broad staff licensure requirement. It removed the regulatory bar to certifying new OPOs but has not yet created a process for doing so.

CMS counts 35 donation service areas in line for competition

OPOs are nonprofits that find potential donors in hospitals and seek authorization from their families. They then recover the organs and arrange delivery to transplant programs. Medicare and Medicaid reimburse their organ procurement costs only while they are certified and designated to a service area, so certification decides whether an OPO can operate at all. According to the final rule, 54 OPOs currently serve the 55 DSAs, with one OPO holding two.

The December 2020 rule replaced self-reported measures with two rates built from federal death records, one for donation and one for transplantation. Each DSA is ranked on both. A DSA lands in tier 1 when both rates reach the top-quartile threshold. Tier 2 means both reach the median without qualifying for tier 1. Tier 3 means either rate falls below the median. The thresholds come from the previous year’s performance, so they rise as the field improves. The first cycle ended July 31, 2026, with 2024 data serving as the final assessment period. Current OPO agreements run through January 31, 2027, and CMS can extend them if appeals or handovers take longer.

The relative design shows up in the counts. In January, CMS reported that between the 2021 and 2023 data years the number of OPOs in tier 1 doubled from 15 to 30 and the number in tier 3 fell from 24 to 10. The final rule’s impact analysis, using the 2026 performance reports, now counts 14 tier 3 DSAs and 21 tier 2 DSAs for 2024. An organization can improve year over year and still land below a median that moved up faster.

Transplant volume has grown. Organ Procurement and Transplantation Network data cited in the rule show 46,634 transplants in 2023 and 49,065 in 2025. At least 100,000 people are on the waiting list at any time. In its announcement, CMS credits the 2020 framework with a 36% rise in donations and a 30% rise in transplants since that rule was issued. That is a before-and-after comparison. It does not separate the rule’s effect from other changes the rule itself describes, such as the growth of donation after circulatory death and wider use of perfusion technology.

The framework has also survived its first merits test in court. On September 29, 2026, in LifeLink Foundation, Inc. v. Kennedy, the U.S. District Court for the Middle District of Florida rejected a challenge by seven OPOs that targeted, among other things, the use of death-certificate data and the 12-month measurement period, according to Hall Render. Other suits remain pending.

Tiers attach to each service area. The survey of process requirements applies to the OPO as a whole, so a failure there can cost an organization every territory it holds.

OPOs can lose one service area without losing certification

The Social Security Act allows only one OPO per service area, but it does not stop one OPO from serving several. The old regulations simply assumed a one-to-one match. The final rule lets an OPO hold more than one DSA, whether it gains the second through a merger, a competition, or a CMS assignment. The OPO can then combine its territories or run them separately. A territory CMS assigns because there was no time for a competition must be kept separate.

The choice has real consequences. When territories are kept separate, CMS judges each one on its own donation and transplantation rates. If one falls to tier 3, CMS removes the OPO’s designation for that territory alone. The OPO stays certified as long as it has another DSA in tier 1 or tier 2, or one still awaiting its first evaluation. The removal can be appealed. If the territories are merged, the combined area is judged as one, and a tier 3 result means decertification of the whole organization.

The process requirements, which cover matters such as hospital agreements and staffing, work the other way. CMS assesses them across the whole OPO, so a serious failure in one territory can put every territory at risk.

CMS’s stated reason is that OPOs told the agency they were reluctant to take over a historically weak area if its numbers would be blended with their own. Separating the scores removes that penalty. CMS also presents the change as a hedge against consolidation, since keeping more territories distinct preserves something to compete for later.

New territories come with a grace period whose length depends on how they were acquired. After a planned merger, CMS holds the OPO accountable once 12 months of data exist. After a competition or a CMS assignment, the new DSA is not judged for recertification until the final assessment period of the following cycle. In CMS’s worked example, an OPO that wins a territory at any point in the 2026 to 2030 cycle will first be judged there on 2032 data, at the 2034 recertification.

CMS added two protections in response to comments. When it assigns a territory because there was no time for a competition, the OPO keeps that territory for the rest of the designation period instead of seeing it reopened, as the proposal would have required. And whenever CMS assigns a territory, whether for lack of time or lack of bidders, the OPO’s territories will not be opened to competition at the end of that cycle merely because they rank in tier 2. A drop to tier 3 still costs the OPO that territory.

Tier 2 OPOs keep their certification but not necessarily their territory

The rule draws a line that will matter for 21 service areas. A tier 2 ranking means the OPO met the minimum standard, so it is recertified if it also passes its survey. But its territory is opened to competition, and the incumbent must win it back. If it loses every competition it enters, CMS will not renew its agreement for designation to a DSA, with at least 90 days’ notice. The OPO remains certified, with no territory, and can bid for other open areas or be assigned one during the next four years. If it still has no DSA when that cycle ends, it has no performance data to show and is decertified then, with appeal rights at that point.

Commenters argued that losing a territory is decertification in all but name and should come with an appeal. CMS declined, holding to its position since 2006 that appeals of competition outcomes would leave the winning OPO and the territory in limbo. The rule therefore codifies that a tier 2 loss carries no administrative appeal.

That gap is the reason the September court decision matters here. In LifeLink, the court held that because CMS offers tier 2 OPOs no administrative route, they may sue in federal court without first exhausting one. Tier 2 OPOs that object to the framework can therefore take their case to a federal judge without passing through CMS’s hearing process.

CMS did not rewrite the selection criteria, but it explained how it will apply them. Tier rank will not be applied mechanically. CMS says it will treat small performance differences between competitors as relatively insignificant, so a marginally better tier 1 challenger does not automatically beat a strong tier 2 incumbent. Incumbency will not be weighed as a separate factor. Applicants must show what barriers to donation they faced at home and what their efforts to overcome them achieved. Contiguity counts but is not decisive.

When a territory does change hands, the incumbent must cooperate and submit a transition plan. The successor files its own plan and progress reports, followed by a final notice within 30 days of completing the handover. Only one OPO can be designated at a time, so the incumbent’s designation ends at the moment the successor’s begins. Apart from voluntary mergers, the main precedent CMS points to is the recent transfer of the South Florida DSA after it decertified Life Alliance Organ Recovery Agency mid-cycle.

OPO decertification hearing requests are due in 15 calendar days

OPOs facing decertification, and now OPOs losing a single tier 3 territory, have a three-stage appeal. CMS first reconsiders its own decision, after which a CMS hearing officer can hold a hearing. The new final stage is a codified, discretionary review by the CMS Administrator. All deadlines are converted to calendar days. The OPO bears the burden of proving, by a preponderance of the evidence, that CMS’s determination should be reversed.

Source: CMS-3409-F, section III.G. Most deadlines run from receipt of the preceding notice or decision, and the regulation text sets each starting point. The hearing date itself must still fall within 60 calendar days of the request.

The sharpest change is the hearing request. Forty business days is roughly eight weeks. The new window is just over two. Commenters said that is too little time to assemble statistical and hospital-level evidence, particularly for smaller OPOs. They also objected that CMS officials may extend their own deadlines while OPOs may not. CMS answered that a hearing request is only a notice. The substantive case can be built afterward, and an OPO can file to preserve its rights and withdraw later.

While an ordinary appeal is pending, the OPO stays certified and continues to be paid. Its territory is not opened to competition until appeals are exhausted. Urgent-need decertification works differently. CMS needs to give only 3 calendar days’ notice rather than 90, and the territory passes to another OPO on the effective date. The OPO then appeals from the outside, without payment in the meantime.

CMS gains a defined basis for immediate decertification

Since 2006, the regulations have let CMS terminate an OPO immediately in cases of urgent need, “such as the discovery of unsound medical practices,” without ever defining the term. The final rule defines it as failures that create an imminent threat to patient health and safety or pose a risk to patients or the public, including failures in governance, in evaluating and managing potential donors, and in procurement, allocation, and transport.

Two points in CMS’s responses to comments shape how the definition will work. First, a single incident can qualify. The test is severity and the need for immediate action, not whether a problem recurs. Second, governance counts. CMS gave the example of a governing board directing staff to act against standards of practice in ways that knowingly endanger patients. Commenters called the definition broad and vague and warned of inconsistent enforcement. CMS said it chose an outcome-based definition so unsafe practices would not slip through gaps, and it plans to issue surveyor guidance. In the same discussion, CMS restated that an OPO must stop the recovery process if signs of life are observed, even after a physician has declared death.

The rule also moves the examples of “adverse events” out of the definition and into the quality improvement requirements, as a list that is explicitly not exhaustive. CMS confirmed that near misses count. Adverse events generally go through an OPO’s own quality program. Unsound medical practices go straight to enforcement.

Research pancreata count as transplants only if islet cells are transplanted

Under the old definitions, a pancreas recovered only for islet cell research counted as a transplanted organ even when no patient received it. The OPO trade group, the Association of Organ Procurement Organizations, had flagged this as a distortion of the rankings, and CMS agreed it could mask weak placement performance. A donor whose only recovered organ is a pancreas sent for islet cell research will still count toward the donation rate, because the Pancreatic Islet Cell Transplantation Act of 2004 requires these pancreata to be counted for certification. The pancreas will count toward the transplantation rate only if islet cells are actually transplanted.

The change applies starting with the 2027 assessment period, which will appear in the 2029 performance reports. To keep the comparison fair, CMS will recalculate the 2026 thresholds without research pancreata. Its internal modeling on preliminary data found minimal effects on tier status.

OPOs must also keep records showing where each organ sent for research ended up, including the institution and principal investigator, along with review board approval where one is required. CMS estimates that about 5,267 organs a year go to research. Roughly 1,650 of them are pancreata that 15 OPOs send for islet cell research.

CMS dropped donor complexity and broad staff licensure proposals

CMS received 129 comment letters on the January proposal. Most of the core enforcement machinery was finalized as proposed. The pieces that would have imposed new clinical or staffing obligations were not.

Source: CMS-3409-F. KDPI is the Kidney Donor Profile Index, a score that estimates how long a donor’s kidney is likely to function compared with kidneys from other donors.

The “medically complex” proposal did not survive disagreement over what the term should cover. Some commenters wanted a KDPI cutoff of 85 rather than 50. Several OPOs said the proposed definition already covered most of their donors and raised concerns about the added burden. Others warned that KDPI-based thresholds could disadvantage underserved communities. CMS concluded there was no consensus on what the term means and said it will revisit the issue if a national standard emerges. Commenters also argued that a requirement on OPOs alone would accomplish little without matching obligations for transplant programs, which decide whether to accept these organs.

The change on new OPOs is a legal reinterpretation rather than an operational one. For years CMS read the OPO Certification Act of 2000 to bar it from certifying any organization that was not already an OPO. CMS now says that is not the best reading of the statute, citing the Supreme Court’s 2024 Loper Bright decision on statutory interpretation. Some commenters argued the statute’s wording plainly limits certification to existing organizations and that only Congress can change that. Until CMS proposes and finalizes a certification process, the field of eligible competitors for the 35 open territories remains the existing OPOs with at least one tier 1 or tier 2 DSA.

CMS puts the added cost at about $16.5 million in the first year

CMS estimates the rule will cost about $16.5 million in its first year ($15.1 million for OPOs and $1.4 million for CMS) and $7.9 million a year after that. These figures are on top of the $126.7 million in annual costs CMS attributed to the 2020 rule. Two assumptions drive most of the total:

• Running more than one territory. CMS assumes up to 14 OPOs will expand into a second DSA and that each will spend about $500,000 a year more on the travel and coordination a second territory requires. That comes to $7.0 million annually.
• Competing. CMS assumes four applicants for each of the 35 open territories, or 140 applications, each taking about 200 staff hours. At a blended $186 an hour, that is $37,200 per application and $5.2 million in total, a one-time cost.

On the benefit side, CMS monetizes only about $0.6 million a year from fewer clarification requests and a one-time $500,000 from avoided transitions. The second figure rests on an illustrative assumption that 5 of 14 successor OPOs will later have mixed results across their territories, and that losing only the weak one saves a $100,000 transition each time.

The analysis does not try to estimate effects on donation or patient outcomes, even though those are the reasons for the policy. It also excludes the general cost of moving a territory from one OPO to another, on the grounds that those costs flow from the 2020 rule. For OPOs, CMS calculates mandatory first-year costs of about $198,000 each, or 0.09% to 2.64% of annual revenue across the 47 independent OPOs, whose revenues range from $7.5 million to $210 million.

OPO competition schedules and territory transfers remain unsettled

Which rules govern the 2026 decisions. The final rule takes effect on January 4, 2027, weeks before current agreements expire on January 31. CMS says it will apply the rule prospectively from its effective date, including to the enforcement actions that close out the 2022 to 2026 cycle, and sees no reason to delay those decisions. Which appeal timelines apply to a particular OPO is likely to turn on when its notice arrives relative to that date. The rule does not spell this out. CMS has said only that it will announce competition schedules in advance.

How many territories actually change hands. Thirty-five is the number of territories CMS expects to open, not the number expected to change hands. Tier 3 incumbents can appeal, and tier 2 incumbents can win their own territories back. CMS’s benefit estimate assumes, for illustration, that the 14 tier 3 territories go to 14 different successors and that no tier 2 territory changes hands.

Whether transitions hold up. For people on the waiting list, the immediate stake is continuity. Hospital referrals and conversations with donor families have to continue without a gap while a new organization takes over. Commenters warned that departing OPOs may struggle to keep staff during a transition. They also worried about losing community trust built over years, including in communities with historically low donation rates. CMS’s view is that a better-performing successor serves those communities better. Evidence on how transitions affect donation is thin, since the main recent precedent is a single territory.

Litigation. LifeLink upheld the 2020 framework, but other lawsuits are pending and the decision could be appealed. The court’s holding that tier 2 OPOs may go directly to federal court makes it more likely that tier 2 OPOs facing the loss of a territory will contest the framework there.

The measurement debate. Many commenters repeated longstanding objections to the measures themselves. They argued that the two rates share a denominator and that the measures disadvantage large OPOs. Others said the measures ignore demographic and geographic differences, or that one year of data is too little. CMS called these objections outside the scope of this rule, and the court rejected some of the same arguments, including the challenge to the 12-month measurement period. Commenters also pressed for shared accountability with donor hospitals and transplant centers, whose acceptance decisions affect whether a recovered organ is transplanted. CMS said it may take that up in future rulemaking.

New entrants. The removal of the 2002 to 2005 requirement matters only once CMS defines how a new organization would be certified, and some commenters dispute that CMS has the authority to do so at all.

About this analysis

Basis. The rule is described from the public inspection version posted October 30, 2026. It was published in the Federal Register on November 3, 2026 (volume 91, number 211), and the effective date is taken from the published version’s DATES section. Page numbers differ between the two versions. Provisions are described as finalized in that text. The court decision is described from a law firm summary, and the opinion itself was not reviewed.

Data notes.

• Tier counts in the final rule are counts of DSAs, based on 2024 performance data published in CMS’s 2026 performance reports. The January 2026 counts (15 to 30 in tier 1, 24 to 10 in tier 3) are counts of OPOs for the 2021 and 2023 data years. Because only one OPO serves two DSAs, the units are nearly but not exactly the same.
• The 35 open territories are CMS’s estimate (14 tier 3 plus 21 tier 2). It is not a count of decertifications or of territories that will change hands.
• Dollar figures are CMS’s nominal estimates. The rule reports first-year costs as both $16.4 million and $16.48 million, and annual quantified benefits as both $598,000 and $583,000. The totals in the rule’s cost tables are the ones used here.
• CMS’s 36% and 30% growth figures come from its October 30 announcement, which does not state the baseline year or data source.
• The published rule states an effective date of January 4, 2027. A plain count of 60 days from publication would give January 2. The official date governs.

Sources

• CMS, Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage, final rule (CMS-3409-F), public inspection document 2026-22381
• Federal Register, Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage, final rule (CMS-3409-F), as published, 91 FR, November 3, 2026
• CMS, Final rule fact sheet, October 30, 2026
• CMS, CMS Finalizes Rule to Help More Organs Reach Patients, press release, October 30, 2026
• CMS, Proposed rule fact sheet (CMS-3409-P), January 28, 2026
• Federal Register, January 2026 proposed rule, 91 FR 4190
• CMS, December 2020 final rule (CMS-3380-F)
• Hall Render, Federal Court Upholds CMS’s OPO Performance Rule but Allows Earlier Judicial Challenges, October 7, 2026
• Association of Organ Procurement Organizations, Statement on lawsuit challenging the CMS OPO final rule
• Becker’s Hospital Review, CMS tightens oversight of organ procurement groups: 7 notes, October 30, 2026

Frequently asked questions

How many organ donation service areas does CMS expect to open to competition?

CMS expects 35 of 55 donation service areas to open to competition, comprising 14 tier 3 areas and 21 tier 2 areas. That is not a count of decertifications or territories that will change hands.

Does a tier 2 OPO lose certification if it loses its territory?

A tier 2 OPO that passes its survey is recertified, but losing its territory in competition results in nonrenewal of its designation agreement, not immediate decertification. There is no administrative appeal of that competition outcome.

What is the hearing request deadline for OPO decertification appeals?

The final rule reduces the deadline to request a hearing from 40 business days to 15 calendar days. It also adds discretionary review by the CMS Administrator after the hearing officer’s decision.

Can an OPO lose one donation service area and keep its certification?

Yes. When territories are evaluated separately, an OPO can lose a tier 3 service area and remain certified if it has another area in tier 1 or tier 2, or one still awaiting its first evaluation.