In a piece for Morning Consult, BIO’s Jim Greenwood writes that while CAR-T cell therapies are changing the way we treat patients with some types of cancer, policies being considered in Washington could delay access to care for individuals covered under Medicare.
“While CAR-T therapies represent a significant benefit and value for patient health outcomes and overall delivery of care, major reimbursement hurdles could prevent individuals from obtaining treatment. Personalized therapies such as CAR-T don’t typically fit neatly into private payer or government payment models, including Medicare, causing potential delays for patients and complications for providers.”
The Centers for Medicare and Medicaid Services (CMS) has taken steps to establish a national coverage determination (NCD) to ensure patients have consistent coverage for CAR-T therapies across the United States. But the draft NCD, which was released in February, was met with voices from a growing number of stakeholders sharing their concerns with the proposed memo. As Greenwood points out, patients would be much better served if CMS were to consider the following when finalizing their NCD:
Modifying the disease state requirements for coverage to account for all FDA-approved indications for CAR-T cell therapy, both presently on the market and for future therapies, as this will ensure that all Medicare patients eligible for CAR-T therapy are able to receive coverage;
Ensuring that all qualified sites with appropriate training and safety capabilities can deliver CAR-T therapy to Medicare patients, across hospital and non-hospital settings of care; and
Ensuring that care for Medicare beneficiaries eligible for CAR-T therapy is not disrupted based on potential confusion or implementation challenges stemming from the NCD.
A final policy was expected in mid-May. However, on May 17th, CMS announced that the final NCD would be delayed, and no timeline has been provided for its publication.
“This delay provides CMS an opportunity to ensure that Medicare patients can fully benefit from groundbreaking CAR-T therapies by making changes to better accommodate future technological advances and align with the Food and Drug Administration’s approved uses of the treatments,” Greenwood adds.
Read Mr. Greenwood’s full op-ed here.