Clinical Trials

The ACA requires payers to cover routine costs of approved clinical trials for the treatment of cancer or other life-threatening diseases, including transplant. Learn which costs are covered, the type of trials that are approved, and trials open to your patients.

Routine Costs are Covered

Routine costs include all services and treatment that would be covered if the patient were not in the trial. (Note: Medicaid and grandfathered plans do not have to comply with this provision of the ACA.) These may include:

  • Transplantation consultation
  • HLA typing of related and, if applicable, unrelated donors
  • Evaluation of disease status and organ function, psychosocial assessments and any other evaluations performed by the center to determine recipient and donor suitability

Patient Must be Enrolled in an Approved Clinical Trial

Approved clinical trials are Phase I, II, III and IV trials that must be approved or funded by one of the following organizations:

  • National Institutes of Health
  • National Cancer Institute
  • Centers for Disease Control and Prevention
  • Agency for Health Care Research and Quality
  • Centers for Medicare and Medicaid Services
  • Food and Drug Administration 

Clinical Trials Open to Your Patients

In addition to your own center’s clinical trials, you can learn more about other clinical trials below:

  • BMT CTN Multi-Center Trials (BMT CTN website) The Blood and Marrow Transplant Clinical Trials Network (BMT CTN), is a federally funded project that conducts large multi-institutional clinical trials addressing important issues in HCT.

  • Medicare Clinical Trials ( Medicare patients with Myelodysplastic Syndrome (MDS), Sickle Cell Disease, Myelofibrosis, and Multiple Myeloma are eligible for HCT coverage under special clinical trials. 

  • A registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Maintained by the U.S. National Institutes of Health.

  • Sickle Transplant Alliance for Research ( Non-profit organization that conducts research to create better transplant approaches to safely achieve cure for children suffering from sickle cell disease. 

How to Appeal a Denial of Coverage for a Clinical Trial

If a patient at your center is denied coverage for a clinical trial, ensure that the patient is eligible for the trial and that it is an approved clinical trial. Contact the patient’s payer to better understand the specific reason for denial.

Use this Clinical Trial Participation Attestation Form (, developed by the American Society of Clinical Oncology, to clarify patient and trial eligibility under the ACA standard with your payers. Learn more about appeals.