I generally portray the US Medicare system as having four approaches to Genomics policy:
- National coverage decisions, of which there are a few important molecular ones
- Exact Sciences FDA approved Cologuard; Foundation Medicine and other FDA CGP tests; a recent NCD that will cover FDA approved future LBx tests for colorectal screening.
- The MOLDX System
- This is an elaborate policy system that operates over several MACs and 29 states.
- The NOVITAS System
- This includes First Coast (Florida) which shares an ownership profile with Novitas.
- Includes PA and nearby states, and TX and nearby states.
- The NGS MAC System
- This includes 3 midwestern states (MN WI IL) and NY and New England
Each of these has distinct features. The NCDs are issued rarely, and only on FDA approved tests.
MOLDX has a very elaborate system that is pretty well known and too large to do justice in a short summary. But a key feature is that new tests and codes generally are nonpayable until after a careful review. There's no "autopay" feature.
The NOVITAS system, I've generally had the impression, had a lot of "uncontrolled" codes that did just autopay (especially Tier 2 codes) at least from 2018 to 2020. In contrast, NGS MAC and MOLDX had almost zero payments for Tier 2 codes. At NOVITAS, they were way over $400M a year, dominating all Medicare spending and sometimes paid to labs featured in Department of Justice investigations (e.g. here).
The NGS MAC system had minimal payments for genomic codes (811xx through 815xx), except they happened to have the geography of two of the largest codes, the Exact Sciences Cologuard test and the Foundation Medicine CGP test.
Changes at NOVITAS
In 2021, 2022, some changes at NOVITAS.
- First, they hired a molecular pathologist medical director in in 2H 2021, Dr. Patrick Mann. Linked In here.
- Second, they produced a unique approach to oncology genomics policy, offering a draft policy that focused directly on paying for genomic tests endorsed by NCCN or a couple other groups. I understand this triggered a lot of "push back" at a public comment meeting, so we'll see where that goes. See DL39365 at CMS. It's described by Novitas in this way:
- Novitas writes, "Multiple reconsideration requests have been received regarding a variety of molecular pathology services. This is a rapidly evolving field and area of study; therefore this LCD addresses testing of DNA and RNA in the context of oncology through the use of multiple evidence-based third-party databases."
- Comment was extended to 9/6/2022.
- I've seen at least three different labs this year that asserted in press releases or websites that they have "Medicare Coverage" - all in Novitas states - but at the least, I myself couldn't find particular verification as to what that coverage was via the Novitas website. (A FOIA request for this information fizzled, too). Hence my guess that Novitas may have a "we pay until we review" policy.
- But it's possible Novitas is backing off of the "tests are covered until we review them" position. Two press releases:
- Pacific Edge Bio issued a press release it was halting stock trading back on July 31, relative to new positioning from Novitas. Entry point here.
- Although it dates back to June, a press release about a large molecular lab in a Novitas stae, Texas, shutting down in Texas and potentially moving operations. Read it - Here. I noted in the CMS 2020 public database by lab, that this lab's payments were substantial $26M. See also another document about this firm.
So overall, a lot of activity occurring around the Novitas MAC and its molecular policies.
I think Novitas is supposed to post a recording or transcript of its open meeting (in June, on DL39365), but I couldn't find that. I know it's supposed to post records of a "CAC" meeting.
THe lab in Point 4.2 above had a press release it was leaving a Novitas state, Texas. I also ran into a press release about a company that was leaving a MolDx state, Alabama, and moving to Florida - here.