Guidance for Coding and Reimbursement for Cell Therapies (25EL-581)

Please note: AABB reserves the right to make updates to this program.

• Educational Track: Technical/Clinical
• Topic: Biotherapies
• Intended Audience: CEOs, CFOs, COOs, Directors, Donor Recruitment Staff, Hospital Blood Banks, Hospitals, Laboratory Staff, Managers/Supervisors, Medical Directors, Nurses, Physicians, Research Scientists, Residents/Fellows, Scientists, Students (MD, MT, SBB), Technologists
• Teaching Level: Advanced, Intermediate

• Director/Moderator: Wanxing Cui, PhD, CABP(H), Director, Cell Therapy Manufacturing Facility, MedStar Georgetown University Hospital, Washington, DC
  Speakers:

  • Susan Leppke, MPH, Senior Director, Public & Strategic Partnerships, Association for the Advancement of Blood & Biotherapies, Bethesda, MD
  • Ronit Slotky, PhD, MSc, CABP, Director, Cell Therapy Manufacturing Facility, Hackensack University Medical Center, Hackensack, NJ

• Program Description

  This program will provide an in-depth exploration of coding and reimbursement for cellular therapies, with a focus on CAR-T, stem cell, and tumor-derived therapies like AMTAGVI. Participants will learn how to navigate the latest CMS rule changes and address reimbursement challenges through case studies from healthcare facilities. The program will equip attendees with practical tools like prior authorization checklists, appeal templates, and medical necessity resources to improve reimbursement processes. Additionally, the program will highlight AABB's ongoing advocacy efforts and discuss potential regulatory changes that could impact future reimbursement strategies.

  Learning Objectives

  After participating in this educational activity, participants should be able to:

  • Explain coding frameworks for various cell therapies, including CAR-T, stem cell, and tumor-derived therapies like AMTAGVI.
  • Interpret the latest CMS rule changes affecting coding and reimbursement.
  • Apply case studies from healthcare facilities to address common challenges and solutions in cell therapy billing.
  • Utilize resources such as prior authorization checklists, appeal letters, and medical necessity templates to streamline reimbursement processes.
  • Discuss AABB's advocacy role and the future impact of regulatory changes on cell therapy reimbursement.

  Registration

  Registration includes access to both the live and on-demand version of this eCast.

  If you are a facility interested in participating in this eCast, simply complete the Group Viewing registration form and AABB will provide detailed instructions to share with your team approximately one week prior to the live program (each team member to register for the program utilizing a promocode). For single viewers, simply click on the Register button below to register.

  Please note: registration for the live eCast will close 1 hour prior to the eCast start time. If you register after this time, you will receive access to the on-demand eCast when it is available.

  Single Viewer	Register
  Group Viewing	Register

  Continuing Education Credit

  This activity is eligible for one (1) continuing education credit/contact hour for Physicians, Nurses (including California-based nursing professionals through CBRN), California Lab Personnel, Florida Lab Personnel and General Participation credit. AABB reserves the right to reduce or increase the number of credits granted based on the final activity duration. For more information on each credit type please visit our Continuing Education Credits webpage.

  There is no financial support for this activity.

  

  In support of improving patient care, this activity has been planned and implemented by the Association for the Advancement of Blood & Biotherapies (AABB) and CME Outfitters, LLC. CME Outfitters LLC. is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

  Physicians (ACCME): CME Outfitters, LLC, designates this live activity for a maximum of one (1) AMA PRA Category 1 Credit^TM. CME Outfitters, LLC, designates this enduring activity for a maximum of one (1) AMA PRA Category 1 Credit^TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

  Claiming Credit
  Live Activity - Upon completion of the live activity, you will receive instructions to complete your evaluation, which is necessary to claim credit and receive your certificate of attendance/completion (credit must be claimed by the date provided in the instructions). The evaluation can be found by logging into the AABB Education Platform.

  Enduring Activity - Once the enduring (on-demand) program is available, you will receive instructions to access the AABB Education Platform. Upon completion of viewing the enduring activity, you will need to complete the evaluation, which is necessary to claim credit and receive your certificate of completion (credit must be claimed by the date provided in the AABB Education Platform).

  Program & Credit Expiration Dates:

  • Live Activity Program Date: October 1, 2025; Credit Expiration Date: November 1, 2025
  • Enduring Activity Program Dates: October 1, 2025 – September 30, 2028; Credit Expiration Date: September 30, 2028

  Disclosure Declaration

  It is the policy of CME Outfitters, LLC, and the Association for the Advancement of Blood & Biotherapies to ensure independence, balance, objectivity, and scientific rigor and integrity in all of their CE activities. Faculty must disclose to the participants any relationships with commercial companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. CME Outfitters, LLC, has evaluated, identified, and mitigated any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process. The following information is for participant information only. It is not assumed that the presence of such relationships will have a negative impact on the presentations.

  Disclosures for the planners of this event can be found here. Disclosures for the program faculty, peer reviewers, and CME Outfitters, LLC. personnel are provided at the beginning of the program.

  Faculty Biographies

  Dr. Wanxing Cui is the Director of the Cell Therapy Manufacturing Facility at MedStar Georgetown University Hospital, where he oversees an FDA-registered operation adhering to standards set by the AABB, CAP, and FACT. With over 27 years of experience in pancreatic islet transplantation, he has significantly contributed to the Pancreatic Islets and Stem Cell Transplant and Cellular Immunotherapy programs at the hospital. Dr. Cui earned his PhD in Molecular Medicine from Kyoto University, Japan, focusing on developing a bioartificial pancreas. He has authored over 70 peer-reviewed publications and holds several biotechnological patents. An active AABB assessor and FACT inspector, he contributes to advancing cell therapy standards. Additionally, he participates in the ISCT's iPSC Joint and Lab Practice Committees and serves as a mentor in ISCT's Professional Education Program (PEP) and AABB's Early Stage Professionals (ESP) programs. Dr. Cui is also a member of the AABB Cellular Therapies Section Coordinating Committee (CTSCC), furthering advancements in cell therapy.

  
  

  Susan Leppke, MPH is the senior director of public policy and strategic partnerships for the Association for the Advancement of Blood & Biotherapies (AABB) where she is responsible for advancing advocacy and driving public policy initiatives on improving access to transfusion medicine and biotherapies. Ms. Leppke has over 15 years of experience in health care management, reimbursement, access-to-care policy and analysis, and stakeholder engagement. Prior to her role at AABB, Ms. Leppke served as the Director of Public and Payer Policy at the National Marrow Donor Program where she led multi-stakeholder teams to successfully pass federal and state policies to protect access to cellular therapies for patients with blood cancer and other blood diseases and disorders. Prior to that, Ms. Leppke managed and led efforts in organ transplant policy where she provided strategic leadership and direction on organ allocation policy, transplant research, and payment analysis, strategically engaging with external stakeholders. Her experience includes leading government affairs and policy teams to drive change in the federal, state, and local legislative and regulatory settings. Ms. Leppke has her master’s degree in public health administration and policy from the University of Minnesota.

  
  

  Ronit Slotky, PhD, MSc, CABP is a professor of oncology at Hackensack Median Health School of Medicine and the Director of the Cell Therapies Manufacturing Facility at the Hackensack University Medical Center. She earned her PhD at the Technion, Israel Institute of Technology in Israel, and completed her post doctorate at Columbia University Medical Center studying proteins’ structure and function, as well her MSc in Biostatistics at Columbia University Mailman School of Public Health in New York. Dr. Slotky has been working in the cellular therapy field for over 15 years and has published numerous scientific articles in the field of cell processing. She is the chair of the AABB Cellular Therapy Section Coordinating Committee and a member of the FACT Quality Management Standards Committee. Her current work and research efforts focus on improving cell processing methods and patients’ outcomes and providing education opportunities for clinicians and researchers.