Friday, June 16, 2023

Nerd Note: Coverage vs Pricing: MolDx Non Covers Test, Then Prices It at $3159

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.