On Friday morning, February 15, 2019, CMS released its proposed national coverage determination on CAR-T therapies. Therapies (whether inpatient or outpatient), are covered, but there are some (commonsensical) requirements on the hospital and the patient must be in a CAR-T outcomes registry.
There is also a clause for coverage that is not necessarily on-label, but endorsed in a compendium.
Early press from Reuters here. Trade press at Biopharma Dive, here. Modern Healthcare, here. MedCity News here.
The full NCD is online at CMS, here.
Full text of the decision is clipped below the break. For the full NCD, which prints at 56 PDF pages, see online. Comment is open for 30 days (to 3/17/2019).
Kymriah and Yescarta CAR-T's are not the most expensive CMS drugs; Luxturna is, at $900,000 (here).
The NCD appears to cover autologous treatment (patient's own cells, re-engineered), but there are efforts underway to potentially use non-autologous CAR-T cells also (MedCity, here; companies include San Diego's Allogene Therapeutics).
[Section 4 is boilerplate that is used and re-used for all CMS NCD CED studies:]
4. All CED studies must adhere to the following standards of scientific integrity and relevance to the Medicare population: