Query: Proposed Cellular Tissue Product (CPT) Regulations Have Been Delayed: Now What?
Federal agencies often delay implementation of proposed regulations at the last minute. The current policies were drafted quite some time ago, with some so ancient that the carriers, such as NGS, pulled them altogether. The current chaos is partially due to conflict between the CMS HCPCS committee, which approves new HCPCS codes for new products after approval of peer review studies and the LOCAL MAC. While these studies are accepted by HCPCS Medical Directors and policy personnel they are not acceptable by others the local MAC medical directors. Thus, despite having an approved HCPCS code, they were going to be denied being included in the now proposed policy postponed LCD until January 2026.
This is just one example as to what to do until a new policy is effective.
1) If you practice in a MAC which has an existing policy, you will continue to follow that LCD.
2) If your MAC does not have a policy, find the LCD in an adjacent MAC for guidance or follow the FDA guidelines for the specific graft material(s) you use.
3) Apply judicious use of the Standard of Care in your community. What are other wound care providers doing with respect to use of CTP and is it similar to yours? If there is no policy and you are abiding by an adjacent MAC's policy and what others in your community are using, it will be very difficult for your MAC to claim abuse.
4) Services performed should always demonstrate medical necessity as it is the over-arching reason why you provide your services.
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