- See the rule from August 12, 2020, Federal Register here.
- See the CMS fact sheet for the proposed rule here.
- See CMS data files that support the proposed rule here.
CMS Updates DOS for Lab Tests
CMS bundles all lab tests related to outpatient services, EXCEPT for human genomic tests, which it accomplishes by artful digressions written into its lab date of service rule (aka 14 day rule). Currently, human molecular tests can be billed by the lab that performs them, whether it be the hospital lab or an outside reference lab.[FN1] This was a change finalized in January 2020 after several years of variations.
Interestingly, CMS does not define "molecular pathology test" very clearly in regulation (414.510), but provides a spreadsheet of tests separately billing, making clear by example what is in or out (billable tests have "Status A" on the spreadsheet.)
Discussions of policy history, and changes, runs from page 49032ff. At page 49035 they get to the point: They want to add cancer-based protein MAAA tests to the tests that are not bundled but may be billed by the laboratory. They believe the format of MAAA CPT codes will allow easy distinction between protein MAAA tests for cancer and other non-protein or non-cancer MAAA tests. The new position will allow payment for protein cancer MAAA tests that in the past weren't separately payable because they weren't MAAA ADLTs. (Whew). At 414.502.510, they add the phrase " ^or a test that is a cancer-related protein-based MAAA test."
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FN1. Tests are paid separately if they are (1) the only service on a claim, (2) preventive services, (3) molecular pathology test [sic], or (4) an ADLT when the ADLT status is based on being a MAAA test and not ADLT status based on FDA approval. By the way, any avenue to billing is allowed; the FMI test is an FDA-approved ADLT, but can be billed separately under the clause it is also a "molecular test." Review of the "Status A" assignments show that microbiology DNA tests are not generally separately billable (not Status A).