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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: NCT01166009This 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
Participating Transplant Centers are required to:
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.
For clinical research questions contact: Sue Logan, CIBMTR-MinneapolisEmail: email@example.comPhone: (763) 406-8575
For Medicare claims questions contact: NMDP/Be The Match Payer Policy teamEmail: firstname.lastname@example.org
For more information about Medicare Coding and Billing
Study Reference Materials:
Study Plan: 17-CMS-SCD