Will CMS' CAR T-Cell Therapy Payment Plan Leave Out Community Practices?

CMS’ proposal last month that any patients seeking cancer treatment with chimeric antigen receptor (CAR) T-cell therapy be enrolled in clinical trials or registries has drawn a variety of responses. But there’s a single word that could mean plenty for patients in large swaths of the country:

Hospital.

Repeat references to the “hospital” setting in the proposed National Coverage Determination (NCD), issued February 15, 2019, concerns representatives for the biotechnology industry and community oncology practices. They fear that highly trained community oncologists already involved in clinical trials could be left out under CMS’ reimbursement plan, which would, in turn, limit which patients gain access to CAR T-cell therapy in the future.

Cancer centers that administer these life-saving therapies, which cost at least $393,000 just for the customized cell-based treatment, have waited nearly a year for CMS to devise a way to pay them. CMS endorsed a value-based plan when Novartis’ tisagenlecleucel (Kymriah) was first approved in August 2017. But by May 2018, officials had backed out of that concept and launched a full NCD process, leaving cancer centers in limbo and limiting access to care. While CAR T-cell therapies are currently approved for a handful of blood cancers, they are being studied in many more, including some solid tumors. A comment period on the proposal ends March 17, 2019.

Representatives for the Biotechnology Innovation Organization (BIO), a trade group for the biotechnology industry, and the Community Oncology Alliance (COA), which represents community oncology practices, told The American Journal of Managed Care^® (AJMC^®) that the wording of the NCD proposal could exclude community practices from Medicare reimbursement for CAR T-cell therapy, even though some practices are already giving patients access to treatment through clinical trials.

Ted Okon, MBA, executive director of COA, told AJMC^® in a recent podcast that it appears CMS wants to gather data that it currently lacks on how seniors respond to CAR T-cell therapy. While this is not a bad idea, Okon said a COA working group convened to address the NCD is concerned that it only mentions “the use of hospitals and outpatient hospital facilities, and not community clinics—not the very sophisticated community practices that do bone marrow transplants and other types of complex procedures.”

BIO has several concerns about the proposed NCD, of which the apparent limit on reimbursement to hospitals is just one. Mallory O’Connor, director of healthcare policy and federal programs, told AJMC^® in an interview that the use of “hospital” throughout the proposal document suggests that site of service will be a potential issue. “This needs clarifying,” she said, echoing Okon’s observation that clinical trials with CAR T-cell therapy are already happening in the community setting.

When asked, Okon said community practices have legitimate concerns about being left with no ability to receive Medicare reimbursement for CAR T-cell therapy. As one reads the NCD proposal, “The disconcerting part is, it’s all about hospitals.”

O’Connor said that besides the need to clarify which sites of service can be reimbursed, BIO’s Transformative Therapy Working Group has identified 3 other broad concerns with the proposal:

• The current proposal says CMS will only pay for CAR T-cell therapy in relapsed/refractory cancer, which reflects current FDA approvals. However, in the future, CAR T-cell or similar therapies may be used as the initial treatment for certain cancers. Already, discussions during the American Society of Clinical Oncology meeting have suggested the therapy may be more successful (and cost-effective) if patients’ immune systems are not weakened by prior rounds of treatment.
• There is great need to clarify implementation dates and requirements, and whether this NCD will serve as a model for treatments similar to CAR T-cell therapy.
• Besides many technical questions around the reporting requirements, there are privacy issues: What if a patient needs treatment but does not want to share their data in a clinical trial or a registry?

Okon told AJMC^® his members also had some concerns about the data reporting requirements. When the NCD proposal was released, Joseph Alvarnas, MD, of the City of Hope, in Duarte, California, and editor-in-chief for Evidence-Based Oncology™, said he feared that the reporting requirements might prove so burdensome that some cancer centers would opt not to offer CAR T-cell therapy to patients.