Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage
Published Date: 1/30/2026
Proposed Rule
Summary
This new rule updates the rules for Organ Procurement Organizations (OPOs) that help collect and share organs for transplants. It adds clearer guidelines, new quality checks, and updates how OPOs compete and appeal decisions to boost organ donations and save more lives. OPOs and transplant patients will feel the impact, with comments open until March 31, 2026, and no new costs announced yet.
Analyzed Economic Effects
9 provisions identified: 3 benefits, 2 costs, 4 mixed.
New Rules for DSA Designation and Competition
CMS would allow an OPO to be designated to more than one Donation Service Area (DSA) and would evaluate each DSA separately on outcome measures while evaluating process performance measures across the OPO's entire organization. CMS would also enable selective removal of an OPO's designation for a DSA where it underperforms and would open tier 2 DSAs for competition from other OPOs.
New QAPI Rules for Complex Organs
OPOs would be required to include medically complex donors and medically complex organs in their Quality Assessment and Performance Improvement (QAPI) programs. Each OPO must annually count medically complex donors from whom it obtained consent, the number of organs recovered from those donors, and the number of medically complex organs transplanted, and must act to improve performance when it finds opportunities.
CMS May Certify New OPOs
CMS proposes to remove Sec. 486.303(e) so the Secretary may certify new Organ Procurement Organizations (OPOs) after January 1, 2000, reversing CMS's prior interpretation. This change would allow certification of new OPO entities.
New Definition for Unsound Medical Practices
CMS proposes to define "unsound medical practices" as failures by OPOs that create an imminent threat to patient health and safety or pose a risk to patients or the public, including failures in governance; donor evaluation and management; and procurement, allocation, and transport practices. Such practices are examples of circumstances that could lead CMS to de-certify an OPO under "urgent need."
Estimated Sector Costs and Benefits
CMS estimates the proposed rule would impose $19.1 million in Year 1 and $6.3 million in subsequent years. Year 1 costs are estimated at $17.9 million for OPOs and $1.2 million for CMS; recurring annual costs are approximately $6.2 million for OPOs and $331,000 for CMS. Quantified benefits are estimated at $884,000 annually plus a one-time benefit of $300,000.
When Successor OPOs Are Held Accountable
The proposed rule would revise when CMS will hold an OPO accountable on outcome measures after it takes over another OPO's DSA and discusses factors CMS would consider when selecting a successor OPO during competition under the tiered re-certification approach.
How Pancreas Research Counts Toward Rates
The proposal would count an individual whose pancreas is procured and used for islet cell research as a "donor" for the donation rate outcome measure, but would remove pancreata used for research from the definition of "organ" and thus exclude them from the organ transplantation rate outcome measure. OPOs would also be required to keep records for organs procured for research, including pancreata used for islet cell research.
Appeals Process and Timing Changes
The proposed rule revises Sec. 486.314 to allow appeals of de-certification and removal of designation to a tier 3 DSA without de-certification, changes all time periods from "business days" to "calendar days," shortens some timeframes, and would codify a CMS Administrator discretionary review with set review periods and possible remand.
Staff Licensure and Scope Requirements
OPOs would be required to assure current State or local licensure, certification, or registration of staff who furnish clinical services, and ensure personnel performing clinical duties act within the scope of that licensure, certification, or registration.
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Key Dates
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