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Myelofibrosis Medicare Study

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Myelofibrosis Medicare Study

Patients with Medicare are eligible for coverage of HCT for myelofibrosis if they participate in a CED clinical trial.
Study Title: Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Myelofibrosis (16-CMS-MF)
Clinical trial number: NCT02934477
Opened: December 1, 2016
Study Objectives:
  • The primary objective of this study is to compare the five-year survival probabilities from DIPSS assessment between the two study arms: alloHCT recipients and non-HCT therapies (ruxolitinib / best supportive care) recipients. In addition to estimate the five-year overall survival probabilities with haploidentical HCT from DIPSS assessment.
  • To provide a mechanism to Medicare Beneficiaries with MF 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.  
    • Select disease option for Myelofibrosis
  3. Complete Form 2555 (CMS - MF Eligibility) 
  4. Complete Form 2400 (Pre-TED) Select  RCI BMT as the study sponsor, and then select 16-CMS-MF from the list of studies.
  5. Complete Form 2402 indicating the disease is Myelofibrosis.
  6. Submission of Comprehensive Report Forms will be required for all myelofibrosis recipients regardless of age at transplant.
  7. Submission of Supplemental MF forms will be required for all myelofibrosis recipients regardless of age at time of transplant
    • Myelofibrosis Pre-HCT form 2556
    • Myelofibrosis Post-HCT form 2557

Patient Eligibility:

  • Primary myelofibrosis, post- essential thrombocythemia myelofibrosis, or post- polycythemia vera myelofibrosis.
  • Int-2 or high-risk disease as determined by the DIPSS.
  • Age ≥55 at the time of Dynamic International Prognostic Scoring System (DIPSS) assessment.
  • For the patients receiving an allogeneic transplant:
    • Donors must be a 6/6 HLA-matched related donors, defined by Class I (HLA-A and -B) intermediate resolution or high resolution DNA-based typing and Class II (HLA-DRBI) at high resolution DNA-based typing (but not monozygotic twins) OR an 8/8 HLA-A, -B, -C, and -DRB1 at high resolution DNA-based typing matched unrelated donor identified through the National Marrow Donor Program (NMDP)/Be The Match. Donors must meet institutional or NMDP/Be The Match selection criteria; there is no age restriction for sibling donors.
    • The planned product must not be umbilical cord blood unit(s) or HLA-mismatched adult donors (< 6/6 HLA alleles for related and < 8/8 HLA alleles for unrelated).
  • If a matched related or unrelated donor cannot be identified, patients may proceed to alloHCT with a suitable haploidentical donor.
  • The patient does not have overlap syndrome
  • 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, 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:
  • 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:
16-CMS-MF Study Plan

Last Updated: 10/15/2018 10:24 AM
CIBMTR