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HCT for MDS Medicare Study (CMS)

Study Title: Assessment of Allogeneic Hematopoietic Stem Cell Transplantation in Medicare Beneficiaries with Myelodysplastic Syndrome and Related disorders - Part I. (10-CMSMDS-1)
**The Center for Medicare Services has approved the CIBMTR HCT study for Medicare patients with MDS as eligible for Coverage with Evidence Development (CED).** 
Opened:  December 15, 2010
Study Objectives: 
  • The primary objective of this study is to prospectively examine outcomes of allogeneic HCT in adults >= 65 years of age with MDS to determine whether their outcomes are similar to those in younger patients.
  • To provide a mechanism to Medicare Beneficiaries with MDS for claims coverage for allogeneic HCT.
  • To provide data requested by Medicare under its CED to make payment on claims for HCT using the existing research observational database of the CIBMTR.

Patients with Medicare will be eligible for claims coverage from CMS under the Coverage with Evidence Development ( CED) mechanism if they participate in this study.


Participating Transplant Center are Required to:

  • Submit the subject registration form-  This form is required for each subject enrolled. CMSMDS Subject Registration Form​.pdf
  • Complete Form 2400 (Pre-TED) with the RCI BMT box checked, and the
  • Study ID# entered as "10-CMSMDS-1".
  • Submit Comprehensive Report Forms to CIBMTR for all registered study patients.

Patient Eligibility:

  • Diagnosis of MDS related disorders, including CMML and therapy-related MDS.
  • Age >= 65 or age <65 and Medicare beneficiary.
  • Willingness to participate and sign informed consent for NMDP/CIBMTR's "Protocol for a Research Database for Hematopoietic Stem Cell Transplantation and Marrow Toxic Injuries (NCT-01166009)"

​Consent Forms: 

 **This study uses the existing research observational database of the CIBMTR to collect data requested by CMS as part of its payment policy.  Participants who wish to receive coverage from CMS must sign the existing IRB approved standard consent for the research observational database.  ( See below).  Additional protocol or consent forms are not required for this study.**

The Research Database protocol and CIBMTR/NMDP IRB approvals, can be found on the Observational Database and Protocol and Consent Forms page.


Study Reference Materials:

To be certain the data collected by the CIBMTR meets the expectations of CMS with regard to the CED, the CIBMTR has created a study plan which can be found here:

Study PlanAssessment of HCT for MDS in Medicare Beneficiaries-Part-1pdf

Guidance for Providers:

The inpatient and outpatient billing manuals provide information on how to bill for search & procurement /donor charges.

For any additional questions regarding Medicare claims, please contact NMDP Payer Policy at:


Study Contact:

Christine Johnson, CIBMTR-Minneapolis, 763-406-4386

Charney Petroske, CIBMTR-Minneapolis, 763-406-8752

Last Updated: 1/21/2016 12:39 PM