Patients with Medicare are eligible for coverage of HCT for multiple myeloma if they participate in a CED clinical trial.
Study Title: Assessment of Allogeneic Hematopoietic Cell Transplantation in Medicare Beneficiaries With Multiple Myeloma (17-CMS-MM)
Clinical trial number: NCT03127761
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: July 25, 2017
Study Objectives:
The primary outcome is to compare five-year OS probabilities between the alloHCT cohort and an age and disease risk matched cohort of autoHCT patients. OS is calculated for all patients from the date of transplant until death from any cause.
To provide a mechanism to Medicare Beneficiaries with multiple myeloma 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
Participating Transplant Centers are required to:
1. Create a CRID in FormsNet following standard CIBMTR process.
2. Complete Form 2554 (CMS Registration Form, an on-demand form) in
FormsNet3.
a. Select disease option for Multiple Myeloma
3. Complete Form 2400 (Pre-TED). Select RCI BMT as the study sponsor, and then
select 17-CMS-MM from the list of studies.
4. Complete Form 2402 indicating the disease is Multiple Myeloma.
a. Eligible classifications include
i. MM-IgG
ii. MM-IgA
iii. MM-IgD
iv. MM-IgE
v. MM-IgM (not Waldenstrom)
vi. MM-light chain only
vii. MM-non secretory
5. Submission of Comprehensive Report Forms will be required for all registered
study patients.
Patient Eligibility:
Medicare beneficiaries
Have Stage II or III multiple myeloma
Are eligible to receive an alloHCT from any suitable allogeneic donor (as determined by the transplant center) including umbilical cord blood
Being treated in a US transplant center
Provide informed consent to participate in the study
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. 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 and Protocol and Consent Forms web page.
Study Contacts:
For clinical research questions contact:
Sue Logan, CIBMTR-Minneapolis
slogan@nmdp.org
763-406-8575
For Medicare claims questions contact:
NMDP/Be The Match Payer Policy team
payerpolicy@nmdp.org
For more information about Medicare Coding and Billing
Study Reference Materials:
Study Plan: 17-CMS-MM
