Medicare beneficiaries nationwide could soon have access to innovative CAR-T cancer therapies – under certain stipulations.
The therapies reboot cancer patients’ immune cells through an infusion process that can save lives – and can cost nearly half a million dollars. The Food and Drug Administration has approved the drugs for certain types of non-Hodgkin lymphoma and leukemia, yet gaps in billing and reimbursement have made some hospitals and clinics wary of providing the drugs.
Now, in a proposed national coverage determination, the Centers for Medicare and Medicaid Services announced its intention to reimburse for CAR-T through a carefully monitored process known as Coverage with Evidence. In short, hospitals or clinics that administer CAR-T therapies must participate in Medicare’s registry, following patients for two years after treatment and reporting details to CMS. Medicare officials can then compare patients’ experiences with clinical trials data as well as standard of care.
As CMS Administrator Seema Verma explained, this allows Medicare to “ensure that it is paying for CAR-T cell therapy for cases in which the benefits outweigh the risks.”
But what about patient access?
The proposal could be an improvement over current policy, a piecemeal approach that has local Medicare administrators making decisions about coverage for CAR-T. And the promise of reimbursement may embolden hospitals and physicians to consider CAR-T for more patients.
But the data collection requirement could pose a challenge. While academic medical centers may have the technology and manpower to accommodate Medicare’s requirements, not all clinics will. That means that CAR-T may become available to patients close to an academic hospital – yet remain out of reach for cancer patients living in rural areas or those who cannot muster the finances to travel for CAR-T treatment. The issue could deepen existing disparities.
CMS’ coverage proposal highlights the promise of innovative medicine in cancer care. But the question of access is one that policymakers must continue to grapple with as immuno-therapies play an increasingly pivotal role in treatment.