Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Non-Hodgkin's lymphoma.
Treatment: Laboratory Test (86152).
The insurer denied the Laboratory Test (86152).
The denial is upheld.

The patient is a male with grade 102 follicular non-Hodgkin lymphoma. He presented with diffuse adenopathy found on chest CT (computed tomography) when being evaluated for pulmonary emboli. An axillary lymph node biopsy was performed on grade 1-2 follicular lymphoma.

The patient sought non-standard treatments in other country. A BIOFOCUS circulating tumor cell assay was performed.

The patient was treated with gemcitabine, which is not recommended for the treatment of follicular lymphoma. He was treated with a dose of 60 mg (milligrams).

Coverage for the testing was denied by the health plan as being investigational. This was appealed by the patient's provider, as he has a long experience with treating patients.

No, the health plan should not cover the Laboratory Test (86152).
The patient had newly diagnosed grade 1-2 follicular lymphoma. A BIOFOCUS circulating tumor cell test was performed on the blood.

This test is not normally used in the United States as it is performed in Germany (BIOFOCUS). The test is not approved by the FDA (United States Food and Drug Administration), and the laboratory performing the test is not CLIA (Clinical Laboratory Improvement Amendments) or CAP (College of American Pathologists) certified.

The test is billed as a test for circulating tumor cells; the provider was using the test as a liquid biopsy. There was no need to perform a liquid biopsy when the patient had an excisional lymph node biopsy with adequate material for any molecular testing from a lymph node biopsy.

The NCCN (National Comprehensive Cancer Network) Guidelines do not support liquid biopsy testing of follicular lymphoma (NCCN Lymphoma, page FOLL-1).

Reviews consider this practice to be investigational, "Although there is still a lack of standardization today, it is important that we begin to incorporate these techniques into clinical practice, given the valuable information they can offer us about the lymphoma." (Bastos-Oreiro)

The test was not medically appropriate and should not be covered.

No, the Laboratory Test (86152) is not more beneficial than any standard treatment for the insured's condition or disease.
The standard treatment for grade 1-2 follicular lymphoma is to observe without treatment until an indication for treatment occurs (NCCN Lymphoma, page FOLL-4). There are no studies that basing treatment on liquid biopsy/measurement of circulating tumor cells will improve health outcomes.

On the basis of the test, the provider is treating with gemcitabine. Gemcitabine monotherapy is well-tolerated, but is not standard of care for the treatment of follicular lymphoma in the United States (NCCN Lymphoma, page FOLL-B 1 OF 5).

On the basis of the BIOFOCUS test, the provider chose to treat with gemcitabine. The records indicate that the dose of gemcitabine used to treat the patient was 60 mg (milligrams). The dose of gemcitabine that is normally used to treat cancer and was studied to treat follicular lymphoma was 1,250 mg/m2 (milligrams per meters squared) (Ganjoo). This trial was stopped due to lack of response.

The patient has an indolent lymphoma and the standard of care for this patient is observation off treatment. The testing in this case is not consistent with the standard of care.