The CMS' plan to offer Medicare coverage nationwide for chimeric antigen receptor T-cell therapy should help hospitals offer the treatment, but hospital groups say it's not a permanent solution.
CAR-T therapy, an immunotherapy that leverages a person's immune cells to fight disease, in 2017 became the first gene therapy to gain regulatory approval from the Food and Drug Administration.
Historically, local Medicare administrative contractors have determined coverage for the therapy, which made it challenging for hospitals and health systems to offer the treatment, as the bundled payments for covering the therapy and its side effects could reach as high as $1.5 million per patient. There are currently two CAR-T treatments on the market, with list prices ranging from $373,000 to $475,000.
Now, the CMS says Medicare will cover the gene therapy nationwide for FDA-approved indications when provided at healthcare facilities enrolled in a related FDA risk evaluation and mitigation strategy. It will also approve the therapy for off-label uses recommended by the CMS-approved compendia.
That's part of a strategy to provide patients with "consistent and predictable patient access" to CAR-T therapies, CMS Administrator Seema Verma said when announcing the decision in early August.
The decision marked the second of two steps the CMS has taken on reimbursement for CAR-T therapy in August. As part of its inpatient payment rule, the CMS increased the maximum add-on payment for CAR-T therapies from 50% of the estimated costs of the treatment to 65%.
That boost may be a step in the right direction for hospitals and health systems looking to offer the treatment, although not as high as some had hoped. "Hospitals and health systems have been taking on this financial burden to ensure access to these lifesaving treatments for patients, and while this proposal is not a permanent solution, it will help in the short term," American Hospital Association Executive Vice President Tom Nickels said after the CMS proposed the payment hike in April.
