A few weeks ago, NOVITAS and FCSO posted a massive new LCD for cancer biomarkers. As I noted at the time, the Final LCD was drastically longer than the proposed version (June 2022), a fact that seems to flaunt Medicare's requirement that LCDs go under notice and comment.
As I pointed out, it grew from 16 page to 68 and from 19 citations to 230. My blog here.
- To almost no one's surprise, I think, CMS has called a halt to that nonsense.
- Specifically, the final LCD did not resemble the proposed LCD.
- Novitas is withdrawing the LCD, and says it will propose a new LCD for notice and comment in a meeting in the near future.
- See news at Genomeweb. Castle stock reported up 42%.
CSTL Stock $25 to $14 to $20
Here's the Novitas remarks:
Did The Massive Changes Run Afoul?
For Medicare regulations, CMS must post them for comment, and any variation in the final versio nmust be "a logical outgrowth" of the options proposed. Otherwise, a new comment period is triggered. While this law applies to CMS regulations, it makes sense that roughly analogous priniciples should apply to LCDs. If you must have a draft, a public comment, and a final, it's "no fair" to hold 95% of the content and denials to appear only in the final.
What Happens Next?
I suspect they will post the entire brontosaurus of an LCD for public comment, for 45 days. This exposes a lot of bloated and/or nonsensical and/or redundant text to public comment.
Will Coverage Change?
Coverage won't necessarily change. If they are opposed to covering certain test, and have the back up that they're not in guidelines or that private payors have mostly ruled "no," they can certainly propose and refinalize the 68 page version - if they want to.
- With complaints on process, CMS can ask teh MAC to re-propose the LCD.
- With complaints on "coverage decisions," historically CMS mostly tells complaining parties that if they dislike an LCD, by all means, apply for an NCD.
- And by the way, they may add that NCDs are only open to FDA-approved tests.
The Novitas BackTrack Announcement
Here is the quote: