CED Clinical Trials
Certain indications for Allogeneic transplant
are only covered in the context of a Medicare-approved, prospective clinical
study, which is known as Coverage with Evidence Development (CED).
What is Coverage with Evidence Development (CED)?
CED is a way for Medicare to provide coverage
of transplant for beneficiaries that are diagnosed with specific indications
and who are enrolled in a CMS-approved clinical trial that meets federal
guidelines. CED clinical trials are multicenter studies and provide a robust
mechanism for Medicare to systematically collect outcomes and cost data to
measure effectiveness of transplant. Medicare uses this information to develop
national coverage through National Coverage Determination (NCD) policies. CED
clinical trial enrollment is not limited to only Medicare beneficiaries, but
Medicare coverage of CED clinical trials is limited to only Medicare
CEDs for Allogeneic HCT
The graphic below depicts the indications for which there are open Medicare-approved clinical trials for allogeneic HCT. The National Clinical Trials number (NCT #) is how you identify the clinical trial.
- MDS CED (CIBMTR, open for enrollment)
- Sickle Cell Disease CED (CIBMTR, open for enrollment)
- Sickle Cell Disease CED (BMT CTN, open for enrollment)
- Myelofibrosis CED (CIBMTR, open for enrollment)
- Multiple Myeloma CED (CIBMTR, open for enrollment)
Track the status and details of the studies on
the left hand side of the CMS CED website.
Resources for CED Studies
Though prior authorization approval is not necessary for eligible Medicare beneficiaries, Medicare still has the authority to reject claims that are improperly coded. To avoid claim rejection, it is important to remain informed about any changes to the study protocol and billing guidance. Be sure to include the National Clinical Trials number (NCT #) on all clinical trial claims, including those for post-transplant follow-up care.
- Refer to the guidelines in the current CMS Claims Processing Manual (CMS.gov) for general billing guidance.
- View Medicare coding guidance (CMS.gov) for patients in these studies: Multiple Myeloma, Myelofibrosis, Sickle Cell Disease, and Myelodysplastic Syndromes.
- View Insurance Guide for Navigating Access to STRIDE2 (BeTheMatchclinical.org) to address common issues such as eligibility, coverage, and reimbursement for this Medicare-approved clinical trial.
- Refer potential clinical research study participants, who are Medicare beneficiaries, to the CMS Medicare & Research Studies pamphlet for general questions regarding cost.
If the patient has Medicare Advantage, all
services covered under the CED should be billed to the Medicare Advantage plan
unless CMS determines that the significant cost threshold is exceeded. If you
have questions on the significant cost threshold, contact CMS. To learn more,
view clarifications from CMS with regard to Medicare billing of clinical trials (CMS.gov).
If you receive a denial notice for a patient enrolled in a clinical trial, the best initial course of action is to work with your local Medicare contractor to understand the reason for the denial and the possible course of action or appeal. If you need additional assistance, contact firstname.lastname@example.org.