Welcome to the First AST Advocacy Brief
Choose your topic: OPTN | CMS | FDA | OMB | HRSA | Legislative & Congressional Updates | AST Updates
The AST is committed to keeping members informed about the policy issues that shape transplantation and affect the patients and professionals we serve. As part of that commitment, we are pleased to introduce our first Advocacy Brief, a new resource designed to provide timely updates on legislative, regulatory, and advocacy developments, while offering greater transparency into the AST's advocacy efforts on behalf of our community.
Advocacy is a core pillar of the AST's mission. Whether we are meeting with federal agencies, responding to proposed regulations, submitting formal comments, or engaging with Congress, our goal is to ensure the voice of the transplant community is represented in the policies that impact our field. Through this brief, we hope to keep you informed not only about what is happening in Washington, but also about the work the AST is doing to advocate for you and your patients.
Your voice matters. We invite you to complete our Public Policy Survey and share your perspectives on the legislative and regulatory issues impacting transplantation. Your feedback will help guide the AST's advocacy priorities and ensure our efforts reflect the needs of our members and the patients we serve.
OPTN Update
OPTN Leadership Provides Update to AST Board and Joint Council
Dr. John Magee, President of the OPTN, and Dr. Shelley Hall, OPTN Vice President, joined the AST Board of Directors and Joint Council meetings during ATC to provide updates on current OPTN activities and engage in discussion with AST leadership on key issues affecting the transplant community.
HRSA Proposes New Rule to Strengthen OPTN Oversight
HRSA has released a Notice of Proposed Rulemaking (NPRM) intended to strengthen oversight and accountability within the OPTN.
According to HRSA, the proposed rule addresses concerns identified through agency investigations, Congressional hearings, and external reporting regarding noncompliance with OPTN policies that have harmed patients and families. The proposal also seeks to align existing regulations with the Securing the U.S. Organ Procurement and Transplantation Act of 2023.
The AST is reviewing the proposal and plans to submit comments during the public comment period.
CMS Update
Medicaid Program; Community Engagement Requirement for Certain Individuals
The AST is preparing comments in response to the Centers for Medicare & Medicaid Services' (CMS) interim final rule, Medicaid Program; Community Engagement Requirement for Certain Individuals. The Society is reviewing the potential implications for transplant patients and will advocate for policies that protect access to care and support equitable transplantation.
FDA Update
AST Meets with FDA to Advance Innovation in Transplant Immunosuppression
AST and ASTS leadership recently met with Dr. Mary T. Thanh Hai, Director of the FDA's Office of New Drugs, to discuss opportunities to advance innovation in transplant immunosuppression.
The discussion focused on qualifying iBox as a Reasonably Likely Surrogate Endpoint (RLSE) to support the evaluation of immunosuppressive therapies through the FDA's Accelerated Approval Program. Establishing validated surrogate endpoints has the potential to accelerate the development and availability of new therapies for transplant recipients.
As part of these efforts, AST and ASTS submitted a joint letter to the FDA supporting the qualification of iBox as an RLSE.
Drug Repurposing for Unmet Medical Needs
The AST submitted comments in response to the U.S. Food and Drug Administration's (FDA) Request for Information on Drug Repurposing for Unmet Medical Needs. Through its comments, the AST provided recommendations to help advance the evaluation and availability of repurposed therapies for serious conditions, ensuring the unique needs of transplant recipients are considered as the FDA explores strategies to accelerate access to promising treatments.
Office of Management and Budget (OMB) Update
AST Responds to Proposed Changes to Federal Grant Regulations
On May 29, 2026, the White House Office of Management and Budget (OMB) released a proposed rule, "Regulation for Federal Financial Assistance," that would significantly change the federal grant-making process.
The AST submitted comments outlining the potential impact of the proposal on the transplant research community and advocating for policies that continue to support scientific innovation and federally funded research.
HRSA Update
HRSA Seeks Public Comment on Living Organ Donation Reimbursement Program
The Health Resources and Services Administration (HRSA) has opened a 30-day public comment period on proposed updates to the eligibility guidelines for the Living Organ Donation Reimbursement Program (LODRP) to implement the Honor Our Living Donors (HOLD) Act. The proposed changes were published in the Federal Register on July 1, 2026.
The AST is preparing formal comments to ensure the transplant community's perspective is represented.
AST Calls for Greater Federal Coordination of Kidney Health
The AST recently submitted a letter to the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) supporting the creation of an Office of Kidney Health and Transplantation within HHS.
The proposed office would improve coordination of kidney disease and transplantation initiatives across federal agencies, helping strengthen national efforts to improve patient outcomes and access to transplantation.
Legislative & Congressional Updates
Congressional Inquiry Focuses on Pediatric Organ Transplantation
Senator Chuck Grassley (R-IA), Chair of the Senate Judiciary Committee, has requested that the U.S. Government Accountability Office (GAO) investigate challenges facing children awaiting organ transplantation.
The requested review includes:
- Wait times for pediatric transplant candidates
- Mortality rates among children on the transplant waiting list
- Federal efforts to increase the availability of organs for pediatric patients
The AST will continue to monitor this effort and provide updates as additional information becomes available.
Organ Transplant Discrimination Prevention Act Advances
The Charlotte Woodward Organ Transplant Discrimination Prevention Act has advanced out of the Senate Health, Education, Labor, and Pensions (HELP) Committee.
The legislation would prohibit discrimination against individuals with disabilities in access to organ transplantation and has already passed the House in a slightly different form. The bill will next be considered by the full Senate. If passed, differences between the House and Senate versions will be reconciled before the legislation is sent to the President for signature.
The AST continues to support policies that promote equitable access to transplantation.
New AST Initiatives
Physician Payment & Workforce Initiative
The AST has launched a new initiative to explore opportunities to strengthen physician payment and valuation for transplant services. Working collaboratively with key organizations and stakeholders, the Society is evaluating long-term strategies to better understand physician work, support appropriate valuation of transplant care, and advance advocacy efforts that strengthen the transplant workforce.
Physician Compensation Survey
As part of this initiative, the AST is developing a physician compensation survey to better understand compensation models and practice patterns across transplantation. The survey findings will help inform future advocacy efforts and support data-driven initiatives to advance the transplant workforce.
We hope this brief becomes a valuable resource for keeping you informed about the policy landscape affecting transplantation. The AST remains committed to advocating on behalf of our members and patients, and we look forward to sharing regular updates on the issues and initiatives shaping the future of our field.
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