CMS issued a Medicare National Coverage Determination (NCD) on April 30, 2012 which allows coverage of Extracorporeal Photopheresis (ECP) for the treatment of Bronchiolitis Obliterans Syndrome (BOS) following lung allograft transplantation under Coverage with Evidence Development (CED) with certain conditions. The clinical study must address one or more aspects of the following question:
Prospectively, do Medicare beneficiaries who have received lung allografts, developed BOS refractory to standard immunosuppressive therapy, and received ECP, experience improved patient-centered health outcomes as indicated by:
- improved forced expiratory volume in one second (FEV1), or decreased rate of decline of FEV1;
- improved survival after transplant; and/or
- improved quality of life?
The results of additional clinical research may potentially provide sufficient evidence to inform future NCDs on the topic. CMS will maintain a list of all approved studies and post that list on this website.
INSTRUCTIONS FOR SUBMISSION OF APPLICATIONS
Study Title: Extracorporeal Photopheresis for the Management of Progressive Bronchiolitis Obliterans Syndrome in Medicare-Eligible Recipients of Lung Allografts
Sponsor: Washington University School of Medicine
ClinicalTrials.gov Number: NCT02181257
CMS Approval Date: 01/07/2014