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Statement from ASH President Roy Silverstein, MD, on Medicare Coverage for CAR T-Cell Therapy

Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers a positive step, but institutions are still not being adequately reimbursed for this therapy

(WASHINGTON, August 8, 2019) — The Centers for Medicare and Medicaid Services (CMS) yesterday announced that it will cover CAR T-cell therapy (CAR-T) for Medicare beneficiaries as long as certain criteria are met. The announcement follows a proposed decision memo CMS released in February. ASH’s comments on the proposal are posted online.

2019 American Society of Hematology (ASH) President Roy Silverstein, MD, of the Medical College of Wisconsin issued the following statement:

“The American Society of Hematology commends CMS for issuing a broad coverage policy for this innovative, potentially life-saving treatment for Medicare beneficiaries and resolving to move forward in a way that limits additional burden on provider institutions and allows for coverage that can include future indications of CAR-T.

In particular, the Society is pleased that the final decision does not include a coverage with evidence development requirement, which ASH strongly opposed because it would have put additional burdens on institutions and allowed them to legally opt out of providing CAR-T while still participating in Medicare. Data are already required to be reported to a central repository. Additionally, ASH is pleased that CMS will expand coverage of approved CAR-T for both the approved indication and for off-label uses supported in one or more CMS-approved compendia. In particular, it was wise to expand coverage to include any FDA-approved indication instead of only relapsed or refractory cancers, which was specifically suggested by ASH. It is important that the criteria for coverage are broad to accommodate more CAR-T products as they are approved for different indications – including for use earlier in the treatment protocol.

It cannot be overlooked that Medicare has now put providers in a difficult position. They are required to provide this therapy, but the Administration is providing very little help to cover its high costs. The Administration’s final inpatient rule, announced last week, does not do enough to adequately reimburse institutions for the cost of care or the cost of the product.

Innovative CAR-T therapies can be the difference between life and death for our patients. We must continue to explore new approaches for ensuring they receive the care they need.”

The American Society of Hematology (ASH) (www.hematology.org) is the world’s largest professional society of hematologists dedicated to furthering the understanding, diagnosis, treatment, and prevention of disorders affecting the blood. For more than 50 years, the Society has led the development of hematology as a discipline by promoting research, patient care, education, training, and advocacy in hematology. ASH publishes Blood (www.bloodjournal.org), the most cited peer-reviewed publication in the field, which is available weekly in print and online. In 2016, ASH launched Blood Advances (www.bloodadvances.org), an online, peer-reviewed open-access journal. 

Amanda Szabo, American Society of Hematology 
[email protected]; 202-552-4914