It's a cliche' that Medicare makes coverage decisions and pricing decisions in separate silos. People ask, will it matter how much clinical impact and HEOR data to MolDx (or CMS?) Usually no.
Here's a fresh example. In a recent blog, I noted that MolDx had released a draft non-coverage decision on the Castle squamous cancer test (a 40 gene, gene expression MAAA). DL39614. (See also here, here.)
Nonetheless, MolDx has offered a gapfill price of $3159 in its April 28 gapfill proposed prices (comment open to late June). So clearly, they didn't assign a price based on the value of the covered test, but on other factors (e.g. prices of similar tests).
- So if your test is non-covered, it may still fare well through the crosswalk/gapfill prices.
- On the down side, if you have hard-won coverage and top-flight HEOR data (let's say you avoid a $20,000 surgery), that may be off the table during pricing, as well.
Extra Nerd Note
MolDx publishes locally-set prices in its Dex registry.
However, the squamous test price is simply not listed there, since it is not covered by MolDx (N for coverage, N for price). It is however listed in MolDx's gapfill filing above.
I've said that the 0315U PLA code, though right not non-covered by MolDx, was priced OK at $3159. Note, however, that Castle's other tests have ADLT pricing, based on being MAAA tests that are covered by Medicare ($7000 range for 81552, 81529). If Castle does get a MAC to cover its squamous test 0315U, it could apply for ADLT pricing [re-pricing] which would then pop to its list price.
