How Four MACs Un-Deny a Test They Refused for Eleven Years

On October 1, 2015, Palmetto GBA and CGS put a local coverage determination on the books saying that Factor V Leiden testing was not reasonable and necessary for anyone. WPS joined the following April, Noridian that June.

The policy does not hedge. Genetic testing for the F5 Leiden variant, the F2 prothrombin G20210A variant and MTHFR is "non-covered except for pregnant patients", and the document is candid about what that exception is worth: pregnant patients "likely represent a very small group of potential Medicare (disabled) patients," their claims "will deny per the policy," and the remedy on offer is an appeal with records attached.

Eleven years later, on October 12, that ends.

"What does eleven years of blanket non-coverage actually do to a code, and what happens the morning it lifts?"

What Replaces It

L40238 at Palmetto, L40242 at Noridian, L40259 at CGS and L40274 at WPS all take effect the same day. Palmetto's record says the request was MAC initiated. What lands is a limited-coverage policy where a non-coverage one stood.

Testing is now covered when the patient presents with VTE tied to non-surgical major transient or hormonal risk factors as ASH defines them, or with cerebral or splanchnic venous thrombosis where the result decides whether anticoagulation continues. There is a third door, and it is the one that moved during comment: a current cancer diagnosis, systemic therapy in the ambulatory setting, low or intermediate VTE risk on a validated tool, and a first-degree relative with VTE.

The scope line is broader than the old code list. The policy covers LDTs, FDA-cleared and FDA-approved tests for hereditary thrombophilia "including Next Generation Sequencing (NGS) tests."

Two organizations commented on the draft.

The College of American Pathologists agreed with the criteria as written. The Association for Molecular Pathology asked for four things.

AMP got one of them. MolDX's response says so plainly: "this LCD now covers hereditary thrombophilia testing for patients with cancer who are receiving systemic therapy in the ambulatory setting and who have a low-to-intermediate risk of VTE and a first-degree relative with a history of VTE." The asymptomatic-family-history ask was refused on statutory grounds, because "coverage by an LCD cannot extend to populations that do not fit within that framework." The request to delete Criterion 4 as duplicative of CLIA was refused too.

That one granted comment is why the billing article has the strange rule it has. If your claim carries only Group 2 diagnoses, you need two of them: a malignant neoplasm code plus Z82.49 or Z83.2 for the family history.