HRSA Tweaks Transplant Network Membership Paperwork Again
Published Date: 12/9/2025
Notice
Summary
HRSA is updating the membership forms for the Organ Procurement and Transplantation Network (OPTN), which hospitals and transplant centers use to join and follow important transplant rules. They’re asking the public to comment on these changes by January 8, 2026. This update helps keep the transplant system running smoothly without adding extra costs or delays.
Analyzed Economic Effects
5 provisions identified: 2 benefits, 3 costs, 0 mixed.
Hospitals Must Follow OPTN Rules
If a hospital performs transplants by Organ Procurement and Transplantation Network (OPTN) members, Section 1138 of the Social Security Act (42 U.S.C. 1320b-8) requires the hospital to follow OPTN rules as a condition of participation in Medicare and Medicaid. This means transplant hospitals must submit membership materials and comply with OPTN-approved requirements to keep Medicare/Medicaid participation.
Lab–OPO Written Agreement Requirement
Transplant histocompatibility laboratories must maintain written agreements with each Organ Procurement Organization (OPO) they serve, unless clinical urgency prevents such an agreement. These agreements must set out the responsibilities and procedures to meet OPTN membership standards per OPTN Bylaw C.2.D (OPO Affiliation).
New Info Security Contact Form Added
A new Information Security Contact Management Form was added to the OPTN membership materials in 2025; this role is required for accessing the OPTN Computer System. Transplant hospitals, OPOs, laboratories, businesses, and individuals who access the OPTN system must provide this new contact information.
Estimated Paperwork Burden Reduced
HRSA estimates the total annualized burden hours for the OPTN membership information collection are 3,548 hours, a decrease of 2,062 hours from the currently approved package. The decrease reflects familiarity with the 2022 forms and committee consultation used to estimate burden.
Application Updates for Labs and Businesses
OPTN membership applications for histocompatibility laboratories and businesses were updated to align with new requirements, and non-substantive edits were made to improve clarity and efficiency. These revisions are intended to streamline submission and review of membership applications.
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