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 beneficiaries.

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.

Medicare Advantage

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). 

Denials     

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 payerpolicy@nmdp.org.