What Happened?

If you or a loved one is waiting for an organ transplant, the federal system that finds and delivers donated organs is about to face new competition rules that could change which organization serves your region, according to a Legis1 review of a new federal rule. The U.S. Department of Health and Human Services (HHS) published the rule, which takes effect Jan. 4, 2027, revising requirements for organ procurement organizations (OPOs). ​

Under new Medicare and Medicaid rules effective Jan. 4, 2027, CMS estimates that 35 of 55 donation service areas (DSAs) will open to competing organ procurement organizations (OPOs): 21 in tier 2 and 14 in tier 3, where the current organization faces removal only after appeals. The final rule also dropped two provisions from the January proposal: definitions of "medically complex donor" and "medically complex organ," and a licensure requirement for clinical personnel.

Why Does it Matter to Me?

At least 100,000 people are on the waiting list for a lifesaving organ transplant at any given time, and another person is added every eight minutes, according to organdonor.gov. The competition rules are meant to push underperforming OPOs to improve or risk losing their territory.

The rule builds on the tiered outcome-measure framework established in the December 2020 OPO final rule, under which a tier 3 service area can lose its designation after appeals, and a tier 2 service area can be opened for competition without decertifying the OPO. Up to 14 OPOs may expand to serve multiple service areas under the new rule.

Both Sides, Now

Many OPOs and associations argued in the 129 comments HHS's Centers for Medicare & Medicaid Services (CMS) received that the performance metrics are biased against larger organizations and measure factors outside their control; CMS responded that those concerns fall outside the scope of this rule and that it stands by the 2020 framework.

A December 2024 study in the American Journal of Transplantation found that the CMS methodology systematically identified larger OPOs as underperforming independently of quality; a separate letter in the same journal challenged that finding, arguing the study's simulation introduced uncertainty that could cause OPOs to be misassigned to tiers.

The Centers for Medicare & Medicaid Services says the rule implements Executive Order 13879, "Advancing American Kidney Health," and it changes Medicare and Medicaid rules for all 54 organ procurement organizations.

What Happens Next?

First-year implementation costs are estimated at approximately $16.4 million, about 13 percent above the $126.7 million annual baseline the 2020 rule established. OPOs that apply to serve additional areas face an estimated total application cost of approximately $5.21 million across the competition cycle, based on 140 applications at $37,200 each.

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