Skip Navigation LinksHome   |   Studies   |   Clinical Trials   |   Medicare Clinical Trials   |   Myelofibrosis Medicare Study
  • Print
  • Share

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 Registration Form 2554. On-Demand form which you will need to create and complete.
    • Select disease option for Myelofibrosis
  3. Form 2555 will become due and must be completed to fully register the patient
  4. Complete Form 2400 (Pre-TED)  
    • Indicate Yes for question 6; Is the Recipient participating in a clinical trial?
    • Select RCI BMT for question 7; Select Study Sponsor.
    • Select 16-CMS-MF for question 9; Select the Study ID Number
    • If Research Database consent signed, select Yes 
  5. Submission of Comprehensive Report Forms will be required for all myelofibrosis recipients regardless of age at transplant.
  6. 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
  • 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. 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:

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 (NCT02934477) listed on the claim. A separate communication will be sent from the NMDP Payer Policy team with more information once CMS issues the technical guidance.

  
The following link provides some initial coding guidance information: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM9620.pdf
 
Study Reference Materials:
Study Plan

Last Updated: 1/31/2017 6:12 AM