In a July 17, 2025 blog, I noted that MolDx had rolled out a new proposed solid organ transplant policy, for molecular tests to detect rejection (e.g. DL40058).
The comment period is wrapping up soon, August 31, 2025.
All the MolDx MACs (WPS, CGS, Palmetto, Noridian) have the same dates on this one.
Original blog here:
https://www.discoveriesinhealthpolicy.com/2025/07/new-clia-policies-at-cms-new-moldx.html
Find the LCD with comment instructions, here.
My comments -
- ALL NEW LCD
- MolDx is rolling out an entirely new LCD on this topic.
- Presumably, when this is finalized, the "current" LCD will be deleted.
- Rolling out an entirely new LCD makes it harder to judge changes in coverage, since you can't just redline the older and newer versions against each other.
- BILLING ARTICLE
- The billing article is very important - at the LCD, at bottom, see DA60146.
- TWO SCENARIOS
- The billing article makes it very clear that there are two scenarios, testing-for-cause and testing-per-protocol (aka surveillance.) Also, tests in this field are often given two Z codes, one for surveillance and one for cause.
- The LCD itself could be more clearly structured around "for cause" and "surveillance" testing.
- Why make the billing article clear about 2 scenarios but not the LCD??
- For example, For Cause testing means XYZ and it is covered when (5 bullet points).
- For example, Surveillance testing means XYZ and it is covered when (5 bullet points).
- "SURVEILLANCE"
- I would suggest using "surveillance" quarterly testing, as this term is also used in post-op cancer surveillance ("MRD" testing) and, in Z code definitions (at DEX Registry).
- Surveillance directs the reader's mind to one kind of testing and is intrinsically meaningful.
- "Per protocol" can mean anything (McDonald's makes Big Macs per protocol.)
