Cellular Tissue Product Policy Effective Date Changed True?

Federal agencies often rescind implementation of proposed regulations until the last minute. The current effect policies were often drafted quite some time ago, with some so ancient, that their carriers, such as NGS, pulled them altogether.

The current chaos is partially due to conflicts between the CMS HCPCS committee, which approves new HCPCS codes for new products after approval of peer review studies. Yet those same studies are not acceptable by others at CMS and the local MAC medical directors. Thus, despite having an approved HCPCS code they were denied inclusion in the now proposed policy postponed until January 2026. This is just one example and there are others.

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 policy. Currently that may be difficult to find as some MACs actually pulled the current policy from their website in anticipation of the proposed policy shortly being enacted. That may take a few days to correct.

2) If your MAC does not have a policy, find the LCD in an adjacent MAC and/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 including medical necessity guidelines. This includes failure to adequate progress from the wound’s baseline. Be sure you are following similar or the same parameters of other wound care providers with respect to their use of CTP.

If there is no policy and you are abiding by an adjacent MAC’s and what others in your community are using, it will be very difficult for your MAC to claim abuse.