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UnitedHealthcare Expands Coverage of Genetic Cancer Tests

by Glenn S. Demby | Feb 28, 2023 | Essential, Laboratory Industry Report, Reimbursement-lir

The health plan issued a new policy expanding coverage of molecular genetic tests for personalized cancer diagnosis, prognosis, and treatment.

Close up of test tubes with blue illustration of DNA strands inside. Genetic testing concept. iStock image. — iStock, undefined

On Feb. 9, UnitedHealthcare (UHC), the largest private health plan in the US, issued a new policy expanding coverage of molecular genetic tests for personalized cancer diagnosis, prognosis, and treatment. The new Medical Policy, which officially takes effect on April 1, covers all UHC Commercial benefit plans, as well as UHC Individual Exchange benefit plans in every state except Colorado, Massachusetts, Nevada, and New York.¹ Although it addresses a broad range of cancer types and testing technologies, most of the provisions are carryovers from previous policy. However, the coverage rules for multi-gene sequencing tests for molecular profiling of solid tumors contain changes that are significant, not to mention extremely positive for certain precision oncology lab test companies including Foundation Medicine, Guardant Health, and MDxHealth. Here’s a briefing on the key takeaways.

Lung Cancer

As before, UHC will cover multi-gene molecular profiling of solid tumor tissue in metastatic non-small cell lung cancer (NCSLC), provided that: (i) molecular profiling hasn’t already been performed on the same tumor; and (ii) the test is either under 50 genes, or meets the criteria for approved companion diagnostic (CDx) for testing on that particular patient.

Solid Tumor Profile Tests Used as a CDx

UHC will also now cover CDx-approved solid tumor profiling tests for lung and other cancers when treatment with an agent with biomarker confirmation is required by its U.S. Food and Drug Administration (FDA)-approved prescribing label. The UHC policy specifically says that Foundation Medicine’s FoundationOne CDx assay will be considered proven and medically necessary if all the following conditions are met:

The individual has an unresectable or metastatic primary solid tumor (other than primary central nervous system tumors in individuals under age 18)

Immune checkpoint inhibitor therapy is being considered for treatment

There has been progression of disease and there are no satisfactory alternative treatment options

No comprehensive genomic profiling (CGP) has been previously performed for this primary tumor type

However, the policy also notes that repeat testing with FoundationOne CDx on tumor tissue after initial use of FoundationOne CDx is unproven and not medically necessary “due to insufficient evidence of efficacy.” It also lists examples of other CGP tests for solid tumors that are unproven due to insufficient evidence of efficacy and thus not covered for use as a CDx:

Oncomap ExTra (Exact Sciences)

NeoTYPE Discovery Profile for Solid Tumors (NeoGenomics)

MSK-IMPACT (Memorial Sloane Kettering Cancer Center)

TheraMap Solid Tumor (Intermountain Healthcare)

CANCERPLEX (KEW Inc.)

Solid Tumor Profile Plus (Genomic Testing Cooperative)

Tempus xT (Tempus)

Liquid Biopsy Sequencing Tests

According to UHC, liquid biopsy cell-free DNA (cfDNA) or circulating tumor DNA (ctDNA) molecular profiling tests of NSCLC are proven and medically necessary when:

No prior molecular profiling has been performed on the same tumor

The patient isn’t medically fit for invasive biopsy or tumor tissue testing isn’t feasible

Either the multigene next-generation sequencing panel has 50 genes or fewer, or the patient meets the criteria for CDx testing set out in the policy

Medicare to Cover Lucence Liquid Biopsy Test for Lung Cancer Treatment

Genetic testing companies have also been making progress on the Medicare coverage front. For example, on Feb. 22, Lucence announced that a revised local coverage determination (LCD) from Medicare Administrative Contractor (MAC) Palmetto GBA provides for Medicare coverage of the firm’s LiquidHALLMARK, a ctDNA liquid biopsy test for use by oncologists in making treatment decisions for advanced lung cancer patients.² The original LCD (L38043) was issued to provide coverage for Guardant Health’s Guardant360 liquid biopsy and other liquid biopsies demonstrating similar performance for the same indications.³

Lucence has been hard at work to demonstrate LiquidHallmark’s non-inferiority versus Guardant360 by performing a head-to-head comparison trial called LIQUIK.⁴ In interim results on 60 LIQUIK participants, the Lucence laboratory-developed test detected at least one of nine actionable genes (G9) in 24 of 33 patients with tissue-confirmed G9 biomarkers while Guardant360 detected at least one such biomarker in 21 of 33 patients. LiquidHallmark also demonstrated concordance with tissue-based profiling of between 94.5 percent and 100 percent, depending on the particular G9 biomarker.⁵

The LIQUIK trial is ongoing but the new LCD is a very encouraging development for Lucence. Under the LCD, Lucence will be able to bill Medicare and Medicare Advantage plans for the test using the specific Medicare DEX code Z00V8.

The policy adds that blood-based sequencing tests with CDx indications will be covered when indicated by a drug’s FDA label. That includes FoundationOne Liquid CDx in advanced or metastatic breast cancer, metastatic NSCLC, metastatic castration-resistant prostate cancer, or recurrent ovarian, fallopian tube, or primary peritoneal cancer as long as:

Patients haven’t previously had CGP testing,

Patients aren’t medically fit for biopsy or tissue testing, and

Treatment with a CDx-labeled drug is being considered

UHC will also cover Guardant Health’s Guardant360 CDx for patients with recurrent, relapsed, refractory, metastatic, or advanced NCSLC under the same patient criteria that apply to FoundationOne Liquid CDx listed immediately above.

According to UHC, circulating tumor cell testing and other liquid biopsy sequencing tests are unproven and not medically necessary. As examples of the latter, the policy lists:

ColonSentry (StageZero Life Sciences)

Epi proColon (Epigenomics)

FoundationOne Heme (Foundation Medicine)

Tempus xF (Tempus)

Prostate Cancer Gene Expression Profiling

The other headliner from the new UHC policy is that it extends coverage for prostate cancer gene expression profiling, specifically naming the MDxHealth Genomic Prostate Score (GPS) test, formerly called Oncotype DX GPS, that MDxHealth recently acquired from Exact Sciences. According to the policy, the test is proven and medically necessary for patients with biopsy-proven, untreated, localized adenocarcinoma, provided that the ordering urologists or oncologists intend to use the test results to assist in their treatment decision-making.