FAQs

CR 12177 was implemented on 9/20/2021, specifying that HCPCS 0540T requires a KX modifier on Part B claims for CAR-T, to acknowledge that the service is being performed in an FDA REMS facility. For Part B claims, the logic that was created will accept modifier KX on code 0540T with an effective date of 8/7/19.

Resources

Reviewed: 10/05/22

The KX modifier is not required for Part A CAR-T claims, it is required for Part B CAR-T claims. Part B claims without the KX modifier will be denied. 

Resources

Reviewed: 10/05/22

No, Part A claims are not edited for modifier KX as it is not required in CR 12177. Part A will not deny based on the presence or absence of modifier KX.

Resources

Reviewed: 10/05/22

A REMS is a program to manage known or potential serious risks associated with a drug product and is required by the FDA to ensure that the benefits of the drug outweigh its risks. Certification is determined by the FDA based on their internal criteria.

Resources

Reviewed: 10/05/22

The facility’s site name and address must be identified as an FDA-approved REMS facility.

Part A does not match site name and address exactly, but will look for other related campuses; e.g., if the REMS is for Hospital X in City, State and Hospital X has an oncological hospital 3 blocks down which is the billing hospital, then Hospital X may be considered as having a REMS. The REMS must also be for the specific drug being administered.

Part B claims processing does not review the facility site name and address, since the KX modifier attests to the facility’s REMS status.

Resources

Reviewed: 10/05/22