Seems like significant news to me.
Palmetto GBA issues Draft Local Coverage Determination Expanding Guardant360 Medicare Coverage to Most Solid Tumor Types
Guardant Health, (GH), announced that Palmetto GBA, a Medicare Administrative Contractor, has posted a draft local coverage determination (LCD) expanding Medicare coverage of the Guardant360 assay from advanced non-small cell lung cancer (NSCLC) to over a dozen advanced solid tumor cancer types with guideline-recommended genomic targets.
The draft LCD would apply to advanced cancer patients who are covered by Medicare for next-generation sequencing of tumor tissue, but have insufficient or unavailable tissue samples. These cases may comprise a significant percentage of advanced cancers, especially those that have spread to the deep viscera, bone, or brain.
“This is an important step toward making sure all Medicare beneficiaries with advanced cancer have timely access to guideline-recommended treatment options,” said Guardant Health co-founder and CEO Helmy Eltoukhy, PhD.
I might be able to shed some light on what this means. The medicare program in the United States is administered through regional contractors (MACs). A MAC sets coverage and payment policies for their region of the country (usually some number of states). Here is somewhat dated list of the MACs:
For any new technology you have to make the case to local MACs that medicare should pay for your technology, under what indications, and how much they should pay.
You can also go for a national coverage decision, but that is very high risk…you either win the whole country if you get a good determination, or you lose the whole country. So I’ve never been part of an organization that has taken that bet (much better to fight it out regionally).
Private insurers usually are heavily influenced by coverage and payment decisions of the MACs.
So this is normal process for new technology and winning each MAC over time is a snowball effect that allows for technology adoption. Watching how this plays out is critical for GH (and any new medical technology).
Now they can get insurance coverage for a wider set of indications in the mid-atlantic states.
I might be able to shed some light on what this means.
Hi Rob, that was very useful indeed. That’s the wonderful thing about our board. People often seem to be able to step forward and explain industry specific important points to us. We really appreciate it.