On November 2, 2019, the Lymphoma Research Foundation sent a letter to Donald Thompson, Director, Division of Acute Care at the Centers for Medicare and Medicaid Services requesting for MS-DRG reclassification for certain cases involving the use of chimeric antigen receptor T-cell (CAR T-cell) therapies. Find request letter below:
The Lymphoma Research Foundation (LRF) is the nation’s largest non-profit organization devoted exclusively to funding innovative lymphoma research and providing patients and healthcare professionals with up-to-date information about this type of cancer. LRF’s mission is to eradicate lymphoma and serve those touched by this disease. It is this commitment to people with lymphoma that motivates us to submit comments regarding the reclassification of Chimeric Antigen Receptor (CAR) T cell therapies from their current Medicare Severity-Diagnosis Related Group (MS-DRG) to a new MS-DRG for fiscal year 2021.
The two CAR T cell therapies which have been approved by the U.S. Food and Drug Administration (FDA) are used by physicians to treat people with large-B-cell lymphoma whose disease has progressed after receiving at least two prior treatment regimens. The FDA noted upon the approval for the first CAR T cell therapy that this treatment marks a milestone in the development of a whole new scientific paradigm for the treatment of serious diseases and that, “gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer.”
It is in this vein and with the affected patient population in mind that we ask CMS to consider the establishment of a specific MS-DRG which reflects the true expenses associated with the administration of this novel therapy outside of the context of a clinical trial. Patients must be afforded the opportunity to access the most effective treatments recommended by their healthcare providers. Inadequate reimbursement can limit an institution’s ability to offer CAR T cell therapy, thereby limiting patient access. Because this therapy is often utilized after a lymphoma patient exhausts all other treatment options, any limitation could be life threatening. This issue must be addressed and ameliorated prior to the expiration of the new technology add-on payment mechanism, which could have the unintended result of impacting an institution’s capacity to treat Medicare beneficiaries with CAR T cell therapy.
We appreciate this opportunity to provide comments to CMS and remain eager to work together to ensure that beneficiaries’ access to this innovative and potentially life-saving therapy is not compromised.
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