The MolDx MACs have posted a final LCD for infectious disease testing. The draft LCD was in comment period around May 2021 and finalized at all four MACs on March 3, 2022. This triggers a 45 day "notice" period (effective date April 17, 2022). The LCD numbers are L38988 (Palmetto), L39044 (WPS), L39038 (CGS), and L39001/39003 (Noridian).
See the draft LCD here.
See the final LCD here.
See the billing/coding article here. It's pretty complex at 52 pages.
A "response to comments" was posted a week later, entry point here.
See the "Technical Assessment" guidance document (in Excel) here. Appeared April 1, 2022.
I have posted a PDF "redline" version of the draft versus final. There are quite a few changes in the final in this LCD. (In contrast, a number of LCDs are finalized with minimal if any changes).
Find the PDF redline version here.
I've also put the documents in a single ZIP file here.
The policy notes it is "not a coverage policy for metagenomic next generation sequencing," or for mass spec or FISH testing. The policy distinguishes FDA and non FDA tests. Most of the LCD focuses on when limited panel testing is required (that is, when more than 1 pathogen is tested.) The LCD also strongly carves out special rules for "expanded" panel testing where "expanded" panel is described as more than 5 pathogens (that is, 6 or more pathogens).
For example, in the >5 pathogens section, bloodstream infection panels are covered "when there is clinical concern for bacteremia" AND ALSO "microbes were seen on a gram stain of blood" AND ALSO the patient is managed in a critical care facility (includes emergency room) AND personnel will rapidly tailor therapy to the result. Note that from a Medicare Part A, Part B, policy perspective, this seems to limit testing to the hospital and ER setting, where microbial tests are bundled to the DRG or the E.R. facility service anyway (there is no separate payment for MolDx to decide to pay or not pay). Om tje Q&A document, they insist "This is not a Part A coverage policy" concurrently stating, "Patients must be in a critical care facility." (?!).
For UTI panels, the patient must be at high risk for UTI complications (e.g. elderly) AND (OR) seen in a specialty urologic care setting.
There are also quite strict, and fairly elaborate, rules for the use of panels in GI or pulmonary disease. Again, for respiratory panels, "the patient must be treated in an appropriate critical care facility," suggesting the patient is already in a hospital or ER, where the microbiology testing would be a bundled service for Medicare patients.
CPT Watchers Note
The policy uses the newest infectious disease panel code, a 2022 AMA CPT code for blood pathogen detection, 6 or more targets, 87154. This was crosswalked last fall to $218.
MolDx Watchers Note
I think this is the first time the four MolDx MACs have released a draft or final policy all on the same day across the several MACs.
MAC Watchers Note
I've commented previously that the Novitas MAC issued an extremely vague draft and final LCD for infectious panels (they're covered if timely and expected to affect care). That might seem like a license to cover anything, but I've warned, the vague wording could also be applied too narrowly by auditors and recoupment entities, creating big headaches for labs. In contrast, the MolDx LCDs here are quite rule-oriented and granular.