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
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 (bethematchclinical.org) Medicare patients with Myelodysplastic Syndrome (MDS), Sickle Cell Disease, Myelofibrosis, and Multiple Myeloma are eligible for HCT coverage under special clinical trials.
- Jason Carter Clinical
Trials Program (jcctp.org) A program created to help patients with blood cancers or blood
disorders and their families find and join clinical trials.
- Clinicaltrials.gov: 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.
Transplant Alliance for Research (curesicklecellnow.org) Non-profit organization that conducts research to create better
transplant approaches to safely achieve cure for children suffering from sickle
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 (asco.org),
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.
- Guidelines for Defining and Implementing Standard Episodes of HSCT Patient Care within the Context of Clinical Trials (BBMT article): Journal article with consensus guidelines to assist investigators, trial sponsors, and transplantation centers in planning for HCT clinical trials, and to inform payers providing coverage for HCT.
- National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1) (CMS.gov) details Medicare coverage for clinical trials costs.
- Insurance Guide for Navigating Access to STRIDE2 Medicare CED Clinical Trial (PDF): Guide to help navigate common issues around access to the Medicare-approved STRIDE2 Clinical Trial.