For a number of years, the Novitas MAC has used an old LCD "Biomarkers for Oncology," which has undergone repeated revisions. Find L35396 here. (The current update is labeled, "R31," the 31st revision.)
On June 9, 2022, Novitas posted what I assume is a new version of the LCD, for 45 days public comment. Find it here: DL39365. Comment info is posted near the bottom of the LCD, comment open until July 23. There's also a new draft billing article, DL59125 here. The LCD also links to a second, existing billing article, MoPath and Genetic Testing, A58917, here.
"Compliance Through Audits"
Novitas says in the opening sentence that compliance will be monitored through post payment ("pay & chase") data analysis or through medical review audits. The policy also states, at the bottom, under "Rationale," that it will allow automated edits.
The LCD views tests as falling in 3 buckets, Diagnostic, Prognostic, Predictive, Therapeutic. (It's unclear to me how the last two differ, even reading their definitions, which seem to overlap)
In the coverage rules, #1 always applies: the patient must have cancer, or a significant suspicion of cancer, AND, genetic testing would be the next step in the clinical management which would directly impact the management.
Then, the test must meet one of several pathways to coverage. #2 has five different criteria which must be met, or (#3) the test is endorsed by NCCN. or (#4) the test is actionable via the OncoKB database, and meets another chain of criteria such as FDA approval or NCCN status.
Pretty Complex
The multiple layers of intersecting rules and chains of OR statements is kind of baffling.
You tend to want to hang on to a few concrete statements (such as endorsement by NCCN). I count at least 16 or more individual statements to verify working through the chain of sections and bullets and sub bullets.
The discussion section describes the three external databases, CLINGEN, NCCN, and ONCOKB, in some detail. (Another one that I'd consider important, but not mentioned, are ASCO guidelines for biomarkers, such as a Summer 2022 ASCO guideline for therapy selection in advanced breast cancer here.)
FCSO
Novitas has two MAC regions, one around Pennsylvania, and one surrounding Texas. It makes decisions in tandem through joint LCDs with FCSO, which is the MAC for Florida and Puerto Rico. Novitas and FCSO are both parts of a complex chain of management entities that are ultimately related to Florida BCBS.
