In accordance with the announcement of CareDx, Inc., Palmetto GBA has issued a draft local coverage determination (LCD) for AlloSure. AlloSure is the first and mere non-invasive test that uses donor derived cell free DNA as a biomarker to straightly measure allograft injury and recognize the probability of active rejection.
Peter Maag, Chief Executive Officer at CareDx said, "This marks a significant milestone in making AlloSure available to kidney transplant sufferers. We’re tracking against a commercial inauguration of AlloSure later in the year of 2017 following the completion of reimbursement discussions. The draft LCD release underscores our leadership role in partnering with the transplant community on novel diagnostic solutions to make better patient management and long-term outcomes.”
The draft local coverage decision was released following completion of the MolDx (Molecular Diagnostics) Technical Assessment procedure by Palmetto GBA. Meanwhile during the technical assessment procedure, subject matter experts and the MolDx team evaluate if an assay indicates clinical utility and fulfills the CMS (Centers for Medicare & Medicaid Services) ‘reasonable and necessary’ criteria. In case to get favorable review outcomes, the assay must also meet analytical and clinical validity standards.
The Centers for Medicare and Medicaid Services (CMS) has granted Palmetto GBA with the administration of the Molecular Diagnostics Program. The MolDx group at Palmetto has collected a wealth of knowledge on the clinical utilization of high value diagnostics. Other Medicare Administrative Contractors that engage in the Palmetto GBA MolDX Program are hoped to also release LCDs for AlloSure in the near future.
In the year of 2016, there were over 19,000 kidney transplants in the US, but about 20 percent will experience rejection in the first 5 years. With a long waiting list to get a kidney transplant, graft loss is devastating. Jim Gleason, TRIO National President claimed, “Once kidney disease sufferers get a transplant, their quality of life primarily improves. Better diagnostics that support the patient management and rejection detection are required. The transplant community looks forward to having the AlloSure test available to support those long-term post-transplant life advantages.”
To find the draft LCD online, please visit https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=37265&ContrId=381&ver=6&ContrVer=1&CntrctrSelected=381*1&Cntrctr=381&name=&DocType=AllProposed&s=34%7c48%7c53%7c58&bc=AggAAAQAAAAAAA%3d%3d&