HCT for MDS Medicare Study (CMS)
Patients with Medicare will be eligible for claims coverage from CMS if they participate in this study. View clinical, billing, and reimbursement information below.
Study Title: Assessment of Allogeneic Hematopoietic Stem Cell Transplantation in Medicare Beneficiaries with Myelodysplastic Syndrome and Related disorders - Part I. (10-CMSMDS-1)
Clinical trial number: NCT #01166009
This study is a sub-study under the CIBMTR Protocol for a Research Database for Hematopoietic Cell Transplantation, Other Cellular Therapies, and Marrow Toxic Injuries NCT01166009
Opened: December 15, 2010
- Primary objective: To prospectively examine outcomes of allogeneic HCT in adults at least 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 CIBMTR.
Participating Transplant Centers are Required to:
- Create a CRID in FormsNet following standard CIBMTR process.
- Complete Form 2554 (CMS Registration Form, an on-demand form) in FormsNet3 for each subject to be enrolled. Select disease option for Myelodysplastic Syndrome.
- Complete Form 2400 (Pre-TED). Select CIBMTR CRO Services as the study sponsor, and then select 10-CMSMDS-1 from the list of studies.
- Complete Form 2402 indicating the disease is Myelodysplastic Syndrome.
- Submit Comprehensive Report Forms (CRF) or Transplant Essential Data Forms (TED) to CIBMTR for all registered study patients.
- Diagnosis of MDS-related disorders, including RA; RARS; RAEB-1; RAEB-2; RCMD; RCMD-RS; isolated 5q– syndrome; CMML; MDS-EB-1; MDS-EB-2; MDS-RS-SLD; MDS-RS-MLD; MDS/MPN; unclassifiable; and therapy-related MDS.
- Age at least 65 or age <65 and Medicare beneficiary.
- Being treated in a US transplant center.
- Provide informed consent to participate in the study.
- Transformation to AML prior to HCT (Medicare will pay for AML)
This study uses the existing research observational database of CIBMTR to collect data requested by CMS as part of its payment policy. Patients enrolled on CIBMTR studies for indications under CED will sign a separate CMS consent form under the Research Database Protocol for participation in a CMS CED-approved study. These patients will be invited to participate in both the CMS CED study and the Research Database protocol. Patient participation in the CMS CED study is not dependent on their participation in the Research Database Protocol. Additional protocol or consent forms are not required for this study.
The Research Database protocol, CMS consent form and CIBMTR / NMDP IRB approvals, can be found on the Observational Database Protocol page.
For clinical research questions, contact:
Beginning May 22, 2019, all questions from centers must be submitted via Center Support in the ServiceNow application. Please include the study ID# 10-CMSMDS in your ticket.
Learn more about Center Support.
For Medicare claims questions, contact:
NMDP Payer Policy team, firstname.lastname@example.org
Learn more about Medicare Coding and Billing.
Study Reference Materials:
10-CMSMDS Study Plan