Medicare Releases Final Local Coverage Determination Providing Coverage of Optune® for Newly Diagnosed Glioblastoma
Medicare published the final rule this morning. This is the one that we have been battling for the last few months, trying to get them to remove the proposed restrictions. Medicare listened to every comment we sent. (Their point by point response is in the link on the article below), and removed the worst ones. We can live with it the way it is. Not perfect, but much better than the proposed rule. I call our campaign a win! The brain tumor community came together on this one. There were 301 comments submitted, 5 from advocacy groups (including the Musella Foundation), and 209 from patients or caregivers, 80 from doctors! Very impressive. Thanks!
They removed the big restriction on where you had to go for treatment.
As for surgery, we commented that some people can't get "maximal debulking surgery". So they did not remove that requirement, but did add the words "where feasible". which effectively removes that one!
They did keep the need to start within 7 weeks of the end of concomitant chemotherapy, but did change from "Temodar" to "chemotherapy", so those that are use a different chemotherapy are still covered.
They kept the restriction on using Optune for 18 hours a day but added an exclusion for those days that you have to limit or interrupt treatment,
They did not change the need to have no evidence of progression but in their comments they mentioned the RANO criteria considers pseudoprogression. Reading the RANO criteria closely, for the time period in which the decision needs to be made, it is hard to claim it is progression even if the MRI is
worse - so I do not think this will be much of a problem.
They did not remove the karnofsky score of 70., and the need for it to be a GBM.
They also added a way for people who were already on Optune and then switch to Medicare can continue if they are using the device and show it is helping.
And they opened the door to appeals if you do not meet any of the criteria!
Overall, much better than I thought we would get, and it was much faster than I thought! Thanks to Medicare for conducting the process in the right way.
Posted on: 07/18/2019
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