CMS rewrites organ procurement rules and opens failing agencies to competition

The Centers for Medicare & Medicaid Services published a final rule that rewrites the conditions for coverage governing the 54 organ procurement organizations that supply transplantable organs across the United States. The rule, identified as CMS–3409–F under RIN 0938–AU54, appears in the Federal Register of Tuesday, 3 November 2026, and takes effect on January 4, 2027.

Fifty-four agencies, fifty-five service areas

The regulation amends 42 CFR Part 486 and was signed by Robert F. Kennedy, Jr., Secretary of the Department of Health and Human Services. The 54 organizations currently serve 55 Donation Service Areas, since one of them holds more than one area. Each area can have only one designated organization at a time, giving the holder a mandated monopoly over procurement in that geography.

CMS framed the rule as a clarification exercise rather than a new accountability regime. It expressly leaves untouched the outcome measures and the three-tier structure created by the December 2020 organ procurement final rule (85 FR 77898), and it does not revisit risk adjustment, data sources or the number of years used to judge compliance.

The agency cited 49,065 organ transplants in 2025, against 48,150 in 2024 and 46,634 in 2023, while at least 100,000 people remain on waiting lists and another name is added roughly every eight minutes. It received 129 comments on the January 2026 proposal (91 FR 4190).

Tiers, competition and removal of designation

The final text sets out what happens to each donation service area once the outcome measures are scored at the close of the agreement cycle:

• Tier 1: the organization keeps its designation for another agreement period, is re-certified if compliant with the survey conditions, and may compete for any open area.
• Tier 2: the organization must win a competition to keep the area; losing every competition triggers a notice of non-renewal.
• Tier 3: designation is removed at the end of the agreement period, and an organization whose areas all fall in this tier cannot compete for any open area at all.

The rule also creates a separate action, removal of designation to a Tier 3 area without de-certification, which an organization can appeal. CMS estimates that 35 areas will be opened for competition in the coming cycle, calculated as 14 Tier 3 areas plus 21 Tier 2 areas, generating roughly four applications per area and about 140 applications overall. It stressed that this is not a forecast that 35 organizations will lose their contracts.

Faster appeals, urgent removals

Appeals are recast in calendar days. An organization will have 20 calendar days from a de-certification notice to seek reconsideration, up from 15 business days, and CMS will issue a written reconsidered determination within 15 calendar days. A request for a hearing before a CMS hearing officer must be filed within 15 calendar days, down sharply from 40 business days, with a decision due within 90 calendar days of the hearing and discretionary review by the CMS Administrator capped at 45 calendar days.

Except in urgent cases, CMS must give written notice of de-certification at least 90 calendar days before it takes effect; when urgent need is invoked, notice can come as little as 3 calendar days ahead, and Medicare and Medicaid payment stops at the effective date.

The rule adds two definitions to § 486.302: “urgent need,” meaning non-compliance that has caused or is likely to cause serious injury, harm, impairment or death to a donor or recipient, and “unsound medical practices,” which now explicitly includes failures in governance. CMS declined to finalize proposed definitions of “medically complex donor” and “medically complex organ,” and dropped a proposed staff licensure requirement, while keeping a rule that the medical director be a licensed physician.

Cost and recordkeeping

CMS puts the rule’s cost at about $16.5 million in the first year and $7.9 million annually thereafter, against roughly $598,000 a year in benefits from reduced compliance-interpretation burden. Organizations must also keep records on organs recovered for research, including institutional review board approval, the research institution, the principal investigator and study contacts, and must report a wider set of adverse events under the quality assessment program.

The change matters because the organizations sit between grieving families and every patient on a transplant list: how quickly a weak performer is replaced, and how much process it gets before removal, determines whether an area’s donors are recovered at all. With 35 of 55 service areas slated to go out to competition, the practical effect of the rule will be felt less in the standards than in the calendar.

Source: Federal Register, Vol. 91, No. 211, 3 November 2026, Rules and Regulations, p. 69390 (official reference: CMS–3409–F, RIN 0938–AU54).