Thirty-eight percent of private payers now cover some type of ctDNA-based panel testing. Is your lab aware of evolving payment policies?
A recent study released by the Journal of the National Comprehensive Cancer Network (JCCN) confirmed that circulating tumor DNA testing coverage is on the rise, with 65 commercial payers and four MACs covering some type of testing as of mid-2019.
A consortium of researchers from the University of California, San Francisco and City of Hope identified a measurable shift in payer policies from 2015-2019 toward greater coverage and movement toward pan-cancer from cancer-specific applications.
ctDNA is a critical biomarker for cancer
Recent scientific advances have revealed that virtually every cancer produces mutations in tumor cells. As cancer cells die, they release tiny pieces of their DNA into the bloodstream – cell-free circulating tumor DNA (ctDNA). Types and levels of ctDNA found in the blood correlate to the nature and stage of cancer. The higher the concentration of DNA, the more advanced the cancer.
In addition to detecting disease, ctDNA can be used to monitor therapies and help reveal potential treatments. Studies have shown that ctDNA testing is a useful tool at every stage of cancer progression. Since testing is as easy as a blood draw and does not require any invasive procedures such as biopsies, there is great hope in the medical community that payers' coverage will continue to expand.
Coverage of ctDNA testing is good news for labs and patients, but limitations to coverage and inconsistencies exist. The JCCN study – which examined Medicare information as well as data from more than 200 payers covering 75% of private US policies – found that payer reimbursement policies varied widely. Some payers specified the type of technology used in the test, others the cancer type, and some only covered a certain test.
Medicare reimbursement for ctDNA testing
Although Medicare does not have an explicit national coverage determination (NCD) for ctDNA-based tests, there is one for advanced cancer sequencing. This NCD approves coverage for ctDNA-testing panels with one crucial caveat: that the panel has FDA approval. As of now, there are no FDA approved tests. However, the four MACs covering testing are using local coverage determinations (LCDs). The study found that these LCDs expanded from non-small cell lung cancer (NSCLC) to NSCLC plus 12 different cancer types from 2017 to 2019. Significantly, the study notes that Medicare policy is shifting to pan-cancer use of testing.
Commercial reimbursement for ctDNA testing
Of the commercial payers that offered liquid biopsy cancer testing coverage (38% of the study), almost 87% had explicit positive or negative coverage policies. Of the positive policies, 11% had coverage tied to monitoring. Disease covered by private coverage had expanded as well, from lung cancer to multiple cancers. One challenge cited by the study authors involves the complexity of assessing and tracking coverage from commercial payers due to the diversity of each payer’s policy development and structure.
Payer coverage for ctDNA testing, now and in the future
In addition to providing a birds-eye view of payer reimbursement for ctDNA testing, the study points out the main challenge toward its utilization: payer coverage.
There is a disconnect between payer coverage, what the test can evaluate, and what information can be used for documented medical decision making. The study states, "there is a conundrum between what the test actually evaluates, what the payer is willing to cover, and the information that the clinician receives and can use to guide clinical decisions… several payers provide coverage for multigene tests but only allow the analysis of a single gene from those tests.”
Since many patients cannot afford tests that are not covered by their insurance, keeping abreast of the latest reimbursement developments for cancer care is critically important. The right revenue management partner for your lab will keep you updated on payer policies that affect your revenue – and consequently, what the organizations that work with you can provide to their patients. Learn more about how Quadax can ensure optimized billing productivity and profitability for your organization. Let’s take on the revenue cycle together.
Harley Ross is Executive Vice President and Chief Revenue Officer with executive oversight over the Revenue Cycle Services (RCS) division which supports Quadax’s full service revenue cycle platform. Part of his role is to lead and support go to market strategies for both existing and new products for RCS in support of new and existing clients. In his time with Quadax, he has a varied background spanning sales and client services leadership and has worked closely with product and operations to help grow the RCS division. Leveraging his experience and knowledge of software and technology that spans over 20 years, he is a passionate executive leader with a focus on delivering solutions to a variety of market segments which spans the spectrum of finance, revenue cycle, managed care, commercial sales and information technology with a specific focus on the laboratory, medical device, diagnostic and durable medical equipment (DME) segments.