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 Sickle Cell Disease Medicare Study

Patients with Medicare are eligible for coverage of HCT for Sickle Cell Disease (SCD) if they participate in an Coverage with Evidence Determination (CED) clinical trial.

Study Title: Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Sickle Cell Disease (17-CMS-SCD)
 
Clinical trial number: NCT01166009
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: November 28, 2017

 
Study Objectives:

  • The primary objective of this observational study is to prospectively compare survival of patients 15 to 50 years of age with SCD who receive allogeneic transplantation compared to those receiving standard of care treatments. 
  • To study transplant-related complications and disease-free survival in patients who received an allogeneic transplant .
  • To provide a mechanism to Medicare Beneficiaries with SCD 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 Sickle Cell Disease.
  3. Complete Form 2558 (CMS - SCD Eligibility)
  4. Complete Form 2400 (Pre-TED). Select RCI BMT as the study sponsor. Then select 17-CMS-SCD from the list of studies.
  5. Complete Form 2402 indicating the disease is Sickle Cell Disease
  6. Submission of Comprehensive Report Forms will be required for all registered study patients.


 Patient Eligibility:

  • Sickle cell disease (HB SS, HB S beta thalassemia or HB SC) with severe signs or symptoms indicating poor prognosis and warranting transplantation. These could include one or more of include the following:
    • Stroke
    • Neurological deficit lasting > 24 hours
    • Recurrent acute chest syndrome (ACS)
    • Recurrent pain crises
    • Red blood cell (RBC) transfusions to prevent vaso-occlusive clinical complications (i.e. pain, stroke, or ACS)
    • High tricuspid valve regurgitant jet velocity (TRJV)
  • Donors may be HLA-matched siblings, mismatched siblings or other relatives (parent, offspring or another relative mismatched to the recipient at 1 or more HLA loci), HLA-matched or mismatched unrelated donors. Donors may donate bone marrow, peripheral blood or umbilical cord blood.
  • Donors with sickle cell trait are eligible to donate. 
  • Age 15 – 50 years.
  • 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 page.

 

Study Contacts:

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# 17-CMS-SCD in your ticket.

https://nmdp.service-now.com/csm

For more information about Service Now


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-SCD


Last Updated: 7/18/2019 3:10 PM
CIBMTR