Insurance Coverage Increasing for Liquid Biopsies, but Limitations Remain

By Marilynn Larkin

July 15, 2020

NEW YORK (Reuters Health) - Although both private payer and Medicare coverage for liquid biopsies has risen over the past several years, there is room for improvement, particularly by Medicare, researchers say.

"Interest in 'liquid biopsy' tests to help target cancer therapies has skyrocketed in recent years," Michael Douglas of the University of California, San Francisco told Reuters Health by email. "However, no one had previously examined whether insurers are paying for these tests."

Douglas and his colleagues analyzed publicly available private payer policies and Medicare national coverage and local coverage determinations (LCDs) for circulating tumor DNA (ctDNA-based) panel tests for cancer, also known as liquid biopsies.

As reported in the Journal of the National Comprehensive Cancer Network, no providers covered liquid biopsies at the beginning of 2016, but 38% of private payers provided coverage as of July 2019. However, most of that coverage was highly specific: 87% for non-small cell lung cancer, 47% for EGFR gene testing, and 79% for specific brand-name tests.

Coverage increased in scope from 2017-2019, from one cancer type to 12 solid/hematologic cancers, and from a single gene (EGFR) to 73 genes (e.g., the Guardant360 test).

Eight final, two draft, and two future effective final Medicare LCDs (February 3 and March 15, 2020) covered non-FDA-approved tests. The draft and future effective LCDs were the first policies to cover pan-cancer use - i.e., one test result is relevant across many tumor types.

However, 45 payers had specific policies against coverage.

The authors state, "The trend in private payer and Medicare coverage is an increasing number of coverage policies, number of positive policies, and scope of coverage...Given that genomic medicine is rapidly changing, payers and policymakers (e.g., guideline developers) will need to continue to evolve policies."

Douglas noted, "We were surprised that some Medicare policies are covering pan-cancer testing. This is surprising because, until now, insurer coverage has generally been limited to just one type of cancer, such as non-small cell lung cancer."

"What is also really exciting for patients and clinicians - but will be challenging for insurers - is the expected emergence of liquid biopsy tests for cancer screening and early detection, in addition to selecting targeted treatment and monitoring response," he said.

"The adoption of these tests would fundamentally change how cancer screening is done in the U.S.," he said, "and thus will require new and innovative assessments to develop coverage policies that are appropriate and equitable in what genomic tests are covered by insurers, and particularly WHY insurers cover or do not cover tests. "

Dr. Aatur Singhi, a surgical and molecular pathologist at UPMC in Pittsburgh, commented in an email to Reuters Health, "While private payer and Medicare coverage for ctDNA is in its infancy, coverage for solid tumor testing of biopsies and surgical material has been debated and has evolved over the last decade. What we have learned from solid tumor testing is that discussion with the insurance provider and requesting preapproval are now a necessity; otherwise, a patient that has been diagnosed with a potentially lethal cancer is faced with significant financial charges that most cannot afford."

Although the study found an increase in providers covering ctDNA tests, and coverage outside of one specific cancer subtype, he said, "the number of payers covering ctDNA tests is still extremely small and mostly focused on lung cancer patients, as this is the area that is the best studied."

"Coverage by an insurer requires an extensive literature review with testing validation data that demonstrates how it can have an impact on patient care," he noted. "This is not a simple task for smaller providers."

SOURCE: Journal of the National Comprehensive Cancer Network, online July 7, 2020.