On May 27, 2020, Noridian dropped another bombshell in announcing they were deleting a proposed MolDx LCD - which had undergone public comment at Noridian. See the Noridian article here.
Noridian states that draft LCDs DL36323 and draft article DA57410 are being retired (without ever having been made effective LCDs).
Then there is an ambiguity. There is a single sentence that states: "This is a limited coverage policy for GeneSight®, NeuroIDGenetix, and other combinatorial pharmacogenomics panels in the treatment of psychiatric illness when ordered by a psychiatrist. GeneSight® and NeuroIDGenetix are covered for patients in whom a two gene panel consisting of CYP2C19 and CYP2D6 is reasonable and necessary." Basically, that means that coverage requires a psychiatrist (not any other kind of clinician) to state he/she is considering at least one psychiatric drug metabolized by CYPC219 and at least one psychiatric drug metabolized by CYP2D6. At that point, when 2 genes must be testing, Noridian will cover a panel of genes (not limited to 2 genes).
Since this is only a web article, it contains to feedback regarding public comments on the policy (Congress requires MACs to post feedback on LCDs) and it contains no rationale for the decision, or Genesight and NeuroIDGenetix were called out and not other panels or brands. (Congress requires LCD coverage decisions to post rationales.)
The article refers the refer to Draft LCD DL38335, as having additional requirements, but it is unusual for a "draft" and unfinished document to be listed as holding the necessary legal requirements.
Finally, three important points:
1) A reader pointed out to me, it's ambiguous whether the statement "This is a limited coverage policy..." applies solely as a description to the reader of the LCD being deleted, or, if it represents the new coverage position adopted by this article. I read the statement about psychiatrists as being the coverage policy positioned by THIS article, but it may be mereley descriptive of the prior thing being deleted.
2) Myriad/Genesight bills from Ohio, not under a west coast policy of any kind. Though there are west coast genetics labs the Noridian decisions, whatever they are, apply to.
3) The article has an effective date of "August 20, 2020" which is weird (neither 30 nor 45 days nor immediate, the more likely effective dates.) It's not related to the one-year rule for draft LCDs, since the draft appeared 10/19/2019.
There is also a legacy, several year old Genesight LCD; not clear what is happening to that, or when.
Noridian Web Article Text
Noridian Web Article Text
MolDX: Combinatorial Pharmacogenomics Limited Coverage Proposed LCD and Billing and Coding: MolDX: Combinatorial Pharmacogenomics Limited Coverage Retirement - Effective August 16, 2020
This proposed Local Coverage Determination (LCD) has been retired under contractor 01112 (NCA), 01182 (SCA), 01212 (AS, GU, HI, NMI), and 01312 (NV).
Medicare Coverage Database (MCD) Number: DL36323 and DA57410
LCD Title: MolDX: Combinatorial Pharmacogenomics Limited Coverage
LCA Title: Billing and Coding: MolDX: Combinatorial Pharmacogenomics Limited Coverage
Effective Date: August 16, 2020
This proposed policy is being retired because it does not provide additional coverage information beyond what is contained in other existing articles. This is a limited coverage policy for GeneSight®, NeuroIDGenetix, and other combinatorial pharmacogenomics panels in the treatment of psychiatric illness when ordered by a psychiatrist. GeneSight® and NeuroIDGenetix are covered for patients in whom a two gene panel consisting of CYP2C19 and CYP2D6 is reasonable and necessary. The policy MolDX: Pharmacogenomics Testing DL38335 contains complete information. All requirements contained in MolDX: Pharmacogenomics Testing DL38335 must be met.