Monday, May 20, 2019

In Unusual Move, CMS Delays Final NCD For CAR-T Therapies

In a very uncommon move, CMS announced on May 17 that it was delaying release of a final version of its National Coverage Determination on CAR-T therapies.

CMS made the announcement in a press release that was only a few words long, here.  They simply state, "A decision is [still] forthcoming."

See coverage at Fierce Healthcare, here.  At Modern Healthcare here.  For a May 10 speech on CMS CAR-T policy by prior FDA commissioner Dr. Scott Gottleib, here.


CMS released a proposed CAR-T decision on February 15, with a final decision normally appearing in 90 days or less, but usually on the 90th day.  See the proposed decision here.

NCDs can include a puzzling mix of obvious and subtle criteria.  For example, the CMS NCD for next generation sequencing requires testing to be provided via a CLIA-certified lab, but other parts of national law also require that.   The NCD proposal for CAR-T requires provision "when prescribed by the treating oncologist" and must have "one physician experienced in cellular therapy" and "a designated care area that protections the patient from transmission of infectious agents."

More to the point, even when the therapy is FDA-on-label, the inpatient or outpatient beneficiary must be enrolled in a registry with follow-up at 3, 6, 12, and 24 months.  Patient-related outcomes must be measured, as well as metrics like disease free survival and overall survival.  If patients are under an indication with NCCN (but not FDA) endorsement, the patient must be in "a CMS approved trial."

Policy Issues

Commenters have raised issues as to whether CMS can/should require clinical trials for patients getting an on-label FDA-approved therapy.   Commenters have also raised issues as to whether the clinical studies required would limit access.   For an open access article on CMS CAR-T policies, here.

CMS determined to pay for inpatient CAR-T via the "New Technology Add-on Payment" process, which pays 50% of the additional costs of a new, costly technology.   Numerous articles have pointed out this may leave hospitals in the red for over $150,000 per patient.  In April 2019, CMS proposed to raise the payment from 50% to 65% beginning with the October 2019 fiscal year (CY2020).  Article at BioPharmaDive here.  Scott Gottlieb discussed CAR-T including CMS policy at some length in a May 10 speech, here.


The tracking sheet for the NCD is here.  The NCD was requested by United Healthcare here.

To read a summary of a May 2019 speech by CMS administrator Seema Verma on Medicare's approach to new technologies and innovation, here.