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HHS/CMS RIN: 0938-AU02 Publication ID: Fall 2019 
Title: Organ Procurement Organizations (OPOs) (CMS-3380-P) 

This rule would propose changes to the standards used to evaluate OPOs and ensure proper data on available organs and transplants is collected.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
EO 13771 Designation: Regulatory 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 42 U.S.C. 1395hh   
Legal Deadline:  None

Statement of Need:

The Executive Order (EO) on Advancing American Kidney Health requires CMS to, within 90 days of the date of the order, propose a regulation to enhance the procurement and utilization of organs available through deceased donation by revising Organ Procurement Organization (OPO) rules and evaluation metrics to establish more transparent, reliable, and enforceable objective metrics for evaluating an OPO’s performance.

Summary of the Legal Basis:

OPOs are required to meet CMS’s Conditions for Coverage (CfCs) under 42 CFR 486.301-360, as well as requirements of the Organ Procurement and Transplantation Network (OPTN), which is operated under a contract managed by HRSA and governed by regulations at 42 CFR part 121. Since OPOs are part of a larger system, the work of an OPO may be affected by changes in OPTN by-laws or requirements, changes in OPTN regulations or contracts that govern the OPTN, and changes in the CfCs or hospital Conditions of Participation (CoPs). In light of existing concerns and the Executive Order, we are developing a proposed rule to establish new outcome measures that will be used to evaluate OPOs for recertification.


This rule is required by the July 10, 2019, Executive Order on Advancing American Kidney Health.

Anticipated Costs and Benefits:

This rule is expected to increase the number of organ transplants through new outcome measures that will be more consistently applied across all OPOs, and further incentivize OPOs to pursue potential donors that previously might have become missed opportunities for donation as well as reduce the discard of transplantable organs. As a result, preliminary data on OPO performance suggest the potential for several thousand additional lifesaving organ transplants per year. We anticipate there will be costs to public and private insurers due to increased transplantations and immunosuppressive drug therapy. Quantifiable cost savings from averted dialysis for kidney transplant recipients and averted end-of-life care might somewhat, but not entirely, offset those costs. We also expect there to be costs if OPOs are de-certified because they cannot meet the outcome measures required by the proposed rule.


OPOs have expressed concerns about the potential outcome measures and made some recommendations for alternatives.

Action Date FR Cite
NPRM  11/00/2019 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Federal 
Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Diane Corning
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Clinical Standards and Quality, MS: S3-02-01, 7500 Security Boulevard,
Baltimore, MD 21244
Phone:410 786-8486