Under current policy, a local Medicare administrative contractor decides whether to cover the therapy, but a national coverage determination would require Medicare to pay for the therapy.
A sticking point for some is that the CMS proposal restricts coverage of CAR-T to hospitals.
While CAR-T is now only administered in hospitals, there are clinical studies exploring administering the treatment in outpatient settings. Oncology providers are very worried that the restriction to only reimburse facilities with a hospital ID could hamper patient access.
“Probably half of oncology providers in the U.S. fall under a hospital management system and the other half are independent of hospitals,” said Dr. Jeff Sharman, an oncologist with a private practice in Oregon and director of hematology research for U.S. Oncology, a McKesson Corp. company that assists physicians with cancer treatment. “It almost divides the medical economics halfway through.”
There are now two CAR-T treatments: Novartis’ Kymriah, with a list price of $475,000; and Gilead Sciences’ Yescarta, which costs $373,000. Both are highly toxic and require administration in the hospital because of the potential for quick onset of negative side effects. Hospitalization and administration costs can push the price tag for the treatments to around $1 million for some patients.
However, Sharman said, the technology behind CAR-T is still being fine-tuned. “As technology evolves and develops, there are ones that have side effects much later and ones that are much less” toxic, Sharman said in an interview. “In those circumstances, it doesn’t make sense that they are administered in a hospital-based setting.”
Drugmaker Celgene, which is pursuing its own CAR-T treatment, said in comments submitted to the CMS that it is conducting multiple studies in outpatient sites, including those that don’t bill Medicare as hospitals.
But in their comments, several systems said they were concerned that the CMS won’t factor in added costs of administering CAR-T when determining coverage. Northwestern Medical Center in St. Albans, Vt., urged the CMS to “factor in costs associated with the administrative, regulatory and training components necessary for the safe delivery of high-quality CAR-T therapy as it develops its Medicare reimbursement model.”
The CMS proposal calls for hospitals to deliver patient-reported outcomes to the agency, but it’s not clear about reporting requirements, cancer centers and hospitals said. “There are still administrative and operational challenges that would need to be defined in order to effectively implement this coverage policy,” according to the University of Texas MD Anderson Cancer Center’s comments.
The center added in its comments that it can be difficult to track patient-reported outcomes if a patient comes to a CAR-T provider for treatment and goes back to its referring facility immediately after the treatment is done.
The Dana-Farber Cancer Institute called for the CMS to eliminate the requirement for patient-reported outcomes for outpatient administration.
“We fail to understand how CMS access to (patient-reported outcomes) data helps answer the questions of whether CAR-T therapy is reasonable and medically necessary,” the center said in comments.
Sharman said that he doesn’t mind the requirement for patient-reported outcomes data collection, but cautioned the CMS to be broad.
“The devil is in the details,” he said. “If this is used as a tool to exclude or bar access to certain locations, then it is problematic.”