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Medicare Expands Coverage of Molecular Cancer Screening Tests

by Glenn S. Demby | May 4, 2023 | Essential, Laboratory Industry Report, Reimbursement-lir

In terms of Medicare coverage, 2023 is shaping up to be a fruitful year—here are five of the most significant approvals so far.

Big genomic data visualization. DNA test, genome map. Genetic testing concept. — iStock, Nobi_Prizue

Despite their growing popularity among providers and consumers, major payors in the US remain dubious about the clinical value of molecular genetic tests. Securing coverage from Medicare and other insurers has, thus, been a frustratingly difficult task for many test makers. However, 2023 is shaping up to be a fruitful year on the Medicare coverage front, particularly for cancer screening products. Most of the new positive coverage determinations have been for molecular oncology profiling tests issued by leading Medicare Administrative Contractor (MAC) Palmetto GBA through its Molecular Diagnostics Services (MolDX^®) program.¹ Here’s a rundown of five of the year’s most significant new coverage approvals so far.

Strata Oncology’s Strata Select^™ Profiling Test

In late April, precision diagnostics firm Strata Oncology announced that its newly launched Strata Select^™ molecular profiling test obtained Medicare coverage for certain patients with solid tumors. The test uses a multivariate biomarker algorithm called the Immunotherapy Response Score to predict whether a patient will benefit from anti-PD-1/PD-L1 checkpoint inhibitor therapy across all solid tumors.

The new positive coverage determination, which was under the Next-Generation Sequencing for Solid Tumors policy of the Palmetto MolDX^® program,² “is the first immunotherapy biomarker algorithm covered by Medicare across solid tumors meeting specified coverage criteria,” according to the company announcement.³The test will be reimbursed at $3,500, according to an email from a company representative.

Epic Sciences’ Breast Cancer Profiling ctDNA Test

A week earlier, Epic Sciences announced that it received a positive Medicare coverage decision from Palmetto MolDX^® for a 56-gene circulating DNA (ctDNA) panel for genomic profiling of metastatic breast cancer. The Epic test is covered under Palmetto’s foundational local coverage determination (LCD) for Plasma-Based Genomic Profiling in Solid Tumors, which provides coverage for Medicare beneficiaries with metastatic breast cancer for whom tissue-based, comprehensive genomic profiling isn’t feasible.

The newly approved panel is part of Epic’s DefineMBC^™ multiomic liquid biopsy test that uses both cell-based and cell-free analyses to comprehensively profile metastatic breast cancer and monitor tumor evolution and treatment response when a tissue biopsy isn’t feasible to perform. Medicare will reimburse the test at $1,934.21, according to media reports. Meanwhile, the company says it’s working with Medicare to secure coverage for the full range of its DefineMBC^™ blood biopsy tests.⁴

Guardant Health’s Guardant360 Response^™ Test

The same Palmetto LCD covering the Epic panel also provides for coverage of Guardant Health’s Guardant360 Response^™ liquid biopsy test for monitoring patient response to immune checkpoint inhibitors by tracking ctDNA levels in blood samples. According to Guardant Health, the test is the “first blood-only liquid biopsy test for monitoring molecular response to immune checkpoint inhibitors” covered by Medicare for beneficiaries with metastatic or inoperable solid tumors who are on an immune checkpoint inhibitor therapy.

The company also notes that the LCD includes coverage for a Guardant360^® CDx or laboratory-developed test to establish a ctDNA baseline before therapy begins, as well as a Guardant360 Response^™ test administered four to 10 weeks after therapy begins to measure ctDNA level changes.⁵ The Medicare reimbursement rate for the test is $3,500, as confirmed by a company representative via email.

In 2022, Palmetto GBA issued positive coverage determinations for the firm’s Guardant360 TissueNext^™ and Guardant Reveal^™ tests.⁶

MDxHealth’s Select MDx Prostate Cancer Test

Meanwhile, MDxHealth announced that it successfully completed the MolDX^® technical assessment process for its Select mdx for Prostate Cancer test, which will now also be covered by Medicare. Select mdx is a urine-based mRNA test for evaluating a patient’s risk for clinically significant prostate cancer.⁷ Although the Medicare reimbursement rate hasn’t yet been set, the expectation is that the test will be comparable to the Bio-Techne ExoDx^™ prostate test at $760, according to media reports.

Lucence’s LiquidHALLMARK^® Liquid Biopsy Test

The first big Medicare molecular cancer test coverage of the year occurred in February when precision cancer care diagnostics company Lucence announced that Palmetto had issued a new LCD covering the firm’s LiquidHALLMARK^®, a ctDNA liquid biopsy test for use by oncologists in making treatment decisions for advanced lung cancer patients. Under the LCD, Lucence will be able to bill Medicare for the test using the specific Medicare DEX code Z00V8.⁸

New Medicare Transplant Rejection Test Coverage Restrictions Bad News for CareDx and Natera
Unfortunately, recent Medicare molecular test coverage developments haven’t all been positive for test makers. Earlier this year, Palmetto MolDX^® revised its reimbursement guidance for molecular tests used to assess a prospective transplant patient’s risk of rejecting solid organs. The policy adds new restrictions by limiting reimbursement to one test per patient encounter, narrowing the scope of acceptable surveillance testing for which the tests are covered and eliminating reimbursement of for-cause tests unless those tests are used instead of a biopsy or to confirm biopsy results.⁹

The revised guidance is especially bad news for genomics transplant company CareDx to the extent it effectively eliminates reimbursement for multimodal approaches used in tandem with the firm’s AlloMap^® and AlloSure^® applications. A report from Precision Medicine Quarterly cites a Wall Street analyst’s suggestion that the new coverage guidance could lop off about $50 million of CareDx’s $191 million kidney testing business.¹⁰

Another leading provider of transplant risk rejection tests that the new Palmetto coverage policy is likely to hurt is Natera. However, the potential damage won’t be as serious since, unlike CareDx, Natera doesn’t provide multimodal testing.