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The progress toward more effective cell therapies for cancer in recent years has been astounding. Leading the way are chimeric antigen receptor T-cell (CAR-T) therapies. The exploration of CAR-T has opened new doors for treating numerous forms of cancer and other diseases. Recently, the FDA approved TecartusTM. This CAR-T therapy is intended to treat relapsed or refractory mantle cell lymphoma, which an area of high unmet medical need. But clinical advancements in CAR-T development have also introduced a myriad of challenges, including how to pay for these inherently expensive treatments. The cost of the therapy is compounded by factors that vary from patient to patient, such as lengthy hospital stays and the level of care each patient receives. On average, CAR-T therapy reimbursement from the Centers for Medicare & Medicaid Services (CMS) is much lower than the cost of the treatment. This causes hospitals to lose an average of $50,000 each time they treat a patient with CAR-T, according to STAT. Through the work of the National Marrow Donor Program® (NMDP)/Be The Match® and Be The Match BioTherapies®, we have insight into the entire cell therapy process. That insight includes the review of reimbursement rules from CMS. This allows our Health Policy and Reimbursement team to offer a unique perspective to CMS. Ellie Beaver, Manager, Health Policy and Reimbursement, NMDP/Be The Match “People who comment on the work that CMS does are usually commenting from the provider side or the patient side or maybe the manufacturing side. We really have visibility into the whole process,” said Ellie Beaver, Manager, Health Policy and Reimbursement, NMDP/Be The Match. “We’re able to make recommendations based on that 10,000-foot view of the cell therapy process.” In October 2018, we covered the CAR-T reimbursement landscape. At that time, CMS was dealing with a labyrinth of increasing costs for the recently approved therapies Kymriah® and Yescarta®. Our NMDP/Be The Match team was working diligently to advocate for a more comprehensive and inclusive Medicare payment model by coordinating with all of the stakeholders involved — from drug manufacturers to providers to patients. Since then, CMS and its affiliates have made important progress reforming the payment structure for CAR-T therapies. Evolving coverage of CAR-T treatments In August 2019, CMS released a decision to cover CAR-T treatment across the U.S. for those receiving Medicare benefits. The landmark decision followed numerous discussions around reimbursement policy and was the first time a national decision had been introduced. “Because of the work that NMDP/Be The Match did, as well as other organizations who advocated for changes, the coverage decision ended up being much broader than initially proposed, which we think serves our patients better,” Ellie said. While that milestone was highly significant, it did not change Medicare’s payment rates for CAR-T treatments. Those payment rates are determined according to CMS’s Inpatient Prospective Payment System (IPPS) rules. IPPS rules establish payment policies for most hospitals. Currently, CAR-T payment rates are set based on the autologous hematopoietic cell transplant (HCT) costs the hospitals report to CMS, and adjusted by hospital-specific factors to arrive at the final payment rate. This generally results in a much lower payment than the actual cost of the CAR-T therapy. Consequently, more specific payment rules are needed to enable more complete reimbursement for CAR-T therapies. Thanks to a recent CMS decision, more specificity related to CAR-T therapies in the payment policy seems likely. In May 2020, CMS released its proposed FY2021 IPPS rule. The rule includes a separate Medicare Severity-Diagnosis Related Group (MS-DRG) for CAR-T treatment. This means that payment rate for CAR-T therapy will no longer be evaluated based on HCT costs, hopefully leading to a much clearer payment process. “It gets the payment closer to the actual cost of CAR-T therapy,” Ellie explained. The comment period on the proposed rule closed on July 10. The final rule will be released by Sept. 1 and take effect on Oct. 1, 2020. The NMDP/Be The Match is among the groups that evaluated the IPPS rule and provided comments, including support for the creation of an MS-DRG for CAR-T cases. The NMDP/Be The Match comments regarding CAR-T Therapy begin on page 9 of the comment letter. Crucial progress for multiple stakeholders While challenges in the CAR-T reimbursement landscape remain, these recently proposed changes in payment bode well for future development of CAR-T therapies. The changes are encouraging for drug development companies, whose teams can now visualize a roadmap for coverage of cell therapies currently in development. They are essential to hospitals, which now have a much greater chance of recouping their cost for administering cell therapy. And, they are transformative for patients whose access to much-needed therapies has previously been hindered by reimbursement challenges. Most importantly, Ellie notes, the changes are indicative of a growing understanding of cell therapy among all stakeholders. She hopes the new rule will set a precedent that will pave the way for years of accessible and affordable treatment. “These decisions are showing that we don’t have to panic about the high cost of these therapies,” Ellie said. “We can figure out a way to pay for them and get the products to the patients who need them.”

How CAR-T reimbursement discussions help advance the field