CMS postpones CAR T-cell therapy coverage decision

CMS on Friday announced it is postponing a final policy decision that will outline how Medicare will cover CAR T-cell immunotherapies nationwide.

Read our take on CMS' proposed CAR T coverage decision

Background: CMS proposes national coverage policy for CAR T-cell therapies

CAR T-cell immunotherapies are a precision cancer treatment that entails extracting immune system T-cells from a patient's blood. The T-cells then are frozen and shipped to the drugmakers' facility, where they are genetically modified to attack the patient's cancerous cells. Physicians then infuse the T-cells back into the patient, at which point the cells begin fighting the cancer.

To date, FDA has approved two CAR T-cell therapies, Kymriah and Yescarta, to treat certain relapsed or refractory leukemias and lymphomas. A full course of treatment—not including hospital stay costs—can cost hundreds of thousands of dollars.

CMS currently does not have a national policy for covering the treatments. As such, coverage decisions are made by individual regional Medicare contractors. When Medicare does cover the therapies, it often only covers a portion of the price.

CMS last year set Medicare Part B reimbursements for CAR T-cell therapies at $400,000 for Yescarta and $500,000 for Kymriah in the outpatient setting. However, most CAR T-cell therapies are administered in the inpatient setting. As such, CMS in its fiscal year 2019 inpatient final rule approved a DRG code for the procedure as well as technology add-on payments that result in a maximum payment of $186,500 per case. However, the current payment does not cover the full cost of what a hospital pays to deliver the treatment, which means hospitals often lose money on the procedure. In addition, patients are expected to pay an average of $36,000 before payment adjustments per case.

CMS in February proposed a national policy under which Medicare would cover CAR T-cell immunotherapies that treat cancer.

Under the proposal, Medicare would be required to cover Kymriah and Yescarta if beneficiaries receiving the treatments agree to participate in a CMS-approved registry or clinical trial for at least two years to assess the treatments' long-term effects. CMS said it would use the data collected on the beneficiaries' outcomes to determine under which cases Medicare will cover CAR T-cell therapies in the future.

But experts said the proposal might further limit Medicare beneficiaries' access to CAR T-cell therapies by placing new administrative burdens on facilities that administer the therapies. That could slow the pace at which beneficiaries can receive the treatments, the experts argued.

About 70 to 80 cancer centers in the United States currently are authorized to administer CAR T-cell immunotherapies, but most of the centers are not actively providing the treatment. There are a number of barriers to more facilities offering the treatment, including the therapy's cost and the expertise required to administer the therapies.

CMS postpones decision on whether to cover CAR T-cell therapies

CMS was scheduled to release the final policy determination on Friday, but the agency instead announced that it "will not be issuing a final National Coverage Determination on CAR T-cell therapy for cancer today."

CMS did not provide a reason for the delay, but said "a decision is forthcoming," Inside Health Policy reports. A CMS spokesperson declined to comment on why the agency postponed the decision, according to Inside Health Policy (King, Modern Healthcare, 5/17; Wilkerson, Inside Health Policy, 5/17 [subscription required]; Dearment, MedCity News, 5/19).

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