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
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 Registration Form 2554 which is an On-Demand form which you will need to create and complete.
a. Select disease option for Multiple myeloma
b. Indicate Yes for question 2; Has the recipient signed an IRB / Ethics Committee-approved consent form for participation in the study?
c. Indicate Yes for question 4; Does the recipient have Medicare coverage?
3. Complete Form 2400 (Pre-TED)
a. Indicate Yes for question 6; Is the Recipient participating in a clinical trial?
b. Select RCI BMT for question 7; Select Study Sponsor.
c. Select 17-CMS-MM for question 9; Select the Study ID Number
d. If Research Database consent signed, select Yes
4. Complete Form 2402
a. Indicate disease classification for question 232; 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
b. Indicate response for Durie-Salmon staging question 235
c. Indicate response for I.S.S. staging question 239; patient must be stage II or stage III for at least one of the staging questions.
5. Submission of Comprehensive Report Forms will be required
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. Participants who wish to receive coverage from CMS must sign the existing IRB approved CMS consent for the research observational database. Additional protocol or consent forms are not required for this study.
The Research Database protocol, consent form, and CIBMTR/NMDP IRB approvals, can be found on the Observational Database and Protocol and Consent Forms 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
Coding and Billing:
There is not a prior authorization process for Medicare CED studies. The patient must be clinically eligible for the study and have their transplant at a participating center. When the claim is filed, it must have an approved ICD-10 Diagnosis code and National Clinical Trial number (NCT03127761) listed on the claim.
View initial coding guidance information.
Study Reference Materials:
