A Critical Medicare Policy Has Been Delayed. Let’s Use This Opportunity to Get It Right

It’s an exciting time for medical innovation. The next generation of breakthroughs has arrived, and the way we treat and cure the world’s most devastating diseases is advancing before our eyes.

But challenges remain, including the way we pay for these medical marvels.

One such category of treatments is known as CAR-T cell therapies. In CAR-T treatment, immune system cells from a patient are extracted, re-programmed to fight cancer, and then infused back into the patient. For many patients, the results have been extraordinary.

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.

To address this hurdle, the Centers for Medicare and Medicaid Services has taken steps to establish a national coverage determination for CAR-T cell therapies for Medicare patients. Typically, NCDs are used by CMS to ensure consistent coverage for therapies across the United States.

The draft NCD, or proposed decision memo, was released in February, and a final policy was expected in mid-May. However, on May 17, 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.

To meet this goal, the final NCD should do the following:

— Modify 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. While the draft NCD would only provide for coverage of CAR-T for patients with a relapsed or refractory cancer diagnosis, clinical trials are currently underway using CAR-T as a first-line treatment, and it may reasonably be expected that new products or new indications of already marketed products for broader uses will gain FDA approval in the future. Unless the final NCD is modified to include all FDA-approved uses, Medicare patients will not be able to benefit from these advances.

— Ensure 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. For certain patients, the non-hospital setting will represent an important additional site of service. What’s more, clinical trials of CAR-T therapies have taken place in non-hospital settings, demonstrating their capability of administering these treatments and their vital role in ensuring that patients are able to access treatment without unduly burdensome travel requirements.

— Ensure that care for Medicare beneficiaries eligible for CAR-T therapy is not disrupted based on potential confusion or implementation challenges stemming from the NCD.

And these concerns join a growing number of stakeholders working to ensure adequate coverage of Medicare’s cancer patients.

For those living with cancer, CAR-T therapies are their best hope. That’s why CMS should recognize the innovative and transformative nature of the therapy and its benefits to Medicare patients and society. Ultimately, this decision hinges on whether Medicare patients deserve access to the latest cancer therapies at treatment centers in their own communities. Let’s hope that CMS gets it right.


Jim Greenwood is president and CEO of the Biotechnology Innovation Organization, and he represented Pennsylvania’s 8th Congressional District in the U.S. House of Representatives from 1993 to 2005.

Morning Consult welcomes op-ed submissions on policy, politics and business strategy in our coverage areas. Updated submission guidelines can be found here.

Morning Consult