It looks like none of the non-MolDx MACs could successfully take on Jurisdiction E, which is being re-bid right now, and take it out of the MolDx policy system. Reasoning follows.
Jurisdiction E (California, Hawaii, Nevada) Is Up For Re-Bid
Jurisdiction E, one of the largest MACs, especially from the perspective of molecular testing, is up for re-bid.
The federal Request for Proposals (RFP) for Jurisdiction E posted on August 20, 2019, with responses due November 4, 2019. See website here, solicitation number 75FCMC19R0023. The anticipated award date for the new contract was posted as August 4, 2020.
(Click through the documents at the bottom of that webpage, 5 at a time, to see the most interesting document, the 150 page statement of work. On my PC, I had to rename as a PDF-type file to open it.)See my cloud copy of the national MolDx statement of work here. Each MAC in the MolDx policy system works with Palmetto under a "Joint Operating Agreement" or JOA; I don't have a copy of that.
Pp. 47-50 describe the medical director duties; there should be 3 FTE medical directors for this MAC.
CMS Caps Contractor at 26% of Workload; Contractor Group at 40%
In 2017/2018, the NGS MAC protested the limit on total share of MAC workload that can be held by any one MAC. It lost. Here. According to the case, CMS caps workload of any one corporate entity to 26% of national MAC workload, and a group of companies shall not hold more than 40% of MAC workload. My understanding is that Palmetto + CGS are a group of companies; and Novitas + FCSO are a group of companies.
Do The Math
Using a table included in the GAO case, I've rearranged the contractors by group.
There are three non-MolDx contractors, NGS MAC, FCSO, and Novitas. Here's my math. FCSO can win California, which has 9.1% of CMS workload, but then the FCSO+Novitas group will have 32%+9% = 41% of CMS workload, more than 40%. So FCSO can't win California, I don't think.
Novitas can't win California, because it already has 25% of CMS workload, basically at its 26% limit.
NGS MAC has 20% of CMS workload, so it can't add 9.1% for California, which would give it 29%, over the 26% limit. However, NGS MAC could spin off into two shell companies under one parent company, and then either NGS MAC company (with 7.8% and 12% respectively) could add the 9% JE MAC.
So, taking this as a sort of puzzle, the only way I see that a non-MolDx MAC could win JE is by NGS MAC splitting into two companies (possibly under a parent company, something discussed in the GAO legal case cited) in which case it could win JE. If that happen, JE might become a non-MolDx MAC. Check back in August 2020 for the result.
See the MolDx federal "Statement of Work" here.
40% of Part B MoPath Claims Are in California
I looked at the national physician/lab/CPT open access database for CY2017 at CMS, which has 9M claim lines. Codes starting with 812xx 813xx 814xx 815xx. This is most of the MoPath codes. In this 2017 data, there were $588M MoPath payments, $244M or 41% in California. $408M or 69% were in MolDx states (29 states). 60% of MolDx payments are in California (244/408).
If you subtract the $118M of payments for Exact Sciences Cologuard, which are paid (1) under an NCD and (2) in a non-MolDx state of Wisconsin, then there are $470M national mopath payments controlled by LCDs, of which $408M or 87% are in MolDx states.
However, if California left the MolDx system, there would be only $164M of payments left in MolDx states ($408M-$244M = $164M; and 164/588 means that MolDx minus California paid 28% of US mopath claims.)
Unrelated to this blog, I noticed in this data for CY2017 that Exact Sciences Cologuard code 81528 is billed primarily by Exact Sciences (231,489 cases for $118,621,908) but also by Mayo in FL, MN, and AZ (FL: 89 cases, $45,606; MN: 18 cases, $8,874; AZ: 158 cases, $79,202.)
If a MAC other than Noridian wins the JE contract, it could go into legal appeal cycles of many months. We know the JE deadline for applications was November 2019; we know the award date is August 2020. I believe that's the go-live date, since I recall the contract review only requires a matter of months. I would expect an announcement of the winner in early spring 2020 and a "go live" date (not just an announcement of the winner) in August 2020.
If a MAC other than Noridian wins the JE contract, it could trigger LCD "stasis" for 6-9 months due to a required harmonization process that suspends issuance of new LCDs.
Many people here about the MolDx "Master Edit File" which is valid for all the MACs participating in MolDx. I was able to get a copy via FOIA. It is an Excel spreadsheet of 13,000 lines - essentially, 13,000 Z codes. 66% of all codes had non-covered status. 4,937 of the 13,000 Z codes were crossed to the unlisted code 81479 (38%). From other data, the use of Unlisted Code 81479 in non-MolDx MACs is almost zero.