Transplant & Organ Procurement

Hall Render’s Transplant & Organ Procurement legal team is uniquely positioned to support clients, including hospitals and health systems, organ procurement organizations (OPOs) and related entities, in navigating the complexities of organ donation, procurement and transplantation. With extensive experience and a deep understanding of the regulatory and operational considerations associated with transplant programs, our team provides guidance tailored to each client’s needs.

Our experience includes evaluating and assessing payment for transplant and organ procurement services, such as billing, cost report adjustments/appeals and analysis of data and costs. We routinely support clients in meeting requirements for establishing and credentialing transplant services, advise on Conditions of Participation and Organ Procurement and Transplantation Network (OPTN) standards and compliance, and provide guidance on consents related to transplant services. Additionally, our team assists in investigations of transplant and organ procurement services by federal agencies, including OPTN, CMS, OIG and other federal and state bodies, and works with policy and procedure development related to organ donation, procurement and transplantation. We help create and implement compliance programs for OPOs and related entities; negotiate contracts with OPOs, providers, managed care organizations and vendors for ancillary services and supplies; and address operational challenges such as laboratory testing and equipment sterilization and maintenance.

The team provides accurate and thorough guidance in a wide range of additional transplant and organ procurement services, including:

• Assisting hospital clients in updating and creating policies and procedures to comply with applicable laws governing organ donation and procurement in the hospital setting.
• Assisting a hospital client in creating a centralized organ procurement and transplant center, including coordination with local hospitals and OPOs.
• Negotiating contracts with OPOs for organ procurement, recovery and transplant services.
• Advising on managed care agreements that are specific to transplant program reimbursement.
• Assisting with the investigation of transplant programs by CMS, Health Resources and Services Administration (HRSA) and OPTN.
• Assisting with the appeal of cost report adjustments related to organ acquisition costs and counting organs.
• Assisting clients with other matters related to organ donation issues.
• Negotiating and developing contracts with third-party vendors for the provision of certain supplies and services supporting transplantation programs.
• Drafting compliance program governing documents.

With extensive experience in navigating organ transplant programs and regulatory oversight, our team delivers tailored, strategic support to help clients ensure compliance, mitigate risk and excel in organ donation and transplantation efforts. Contact us today to get started.