New Guidelines to Help Payers Navigate NGS Testing in Cancer

Roxanne Nelson, RN, BSN

August 19, 2015

Next-generation sequencing (NGS) technologies enable the rapid generation of data by their ability to sequence massive amounts of DNA in parallel, using diverse methodologies.

Some NGS tests are used to identify an elevated risk for certain hereditary cancers (such as the Myriad myRisk Hereditary Cancer test, and tests from Ambry Genetics and GeneDx). However, NGS technology can also be used to identify mutations in cancer patients that could prompt the off-label use of targeted cancer therapeutics.

Although their use could help fulfill the promise of personalized medicine, particularly in oncology, NGS tests are not the standard of care. As a result, insurance coverage is uneven and unpredictable.

To help tackle this problem, the Center for Medical Technology Policy (CMTP) has issued draft guidelines for health insurance coverage of NGS-based testing in oncology.

"The lack of predictable coverage and reimbursement policies that anticipate the rapid emergence of new genomic tools could become a hindrance to cancer care," said Sean Tunis, MD, CEO of CMTP and a former chief medical officer for the Center for Medicare and Medicaid Services (CMS), in a statement.

"Getting agreement on guidelines for coverage of targeted NGS gene panels is a crucial first step toward more comprehensive and forward-looking policies for genomics in clinical medicine," he added.

CMTP is an independent nonprofit organization dedicated to developing an evidenced-based healthcare system that includes input from numerous parties. As part of their Green Park Collaborative, these guidelines were developed through a multistakeholder process that includes NGS testing and technology companies, medical professional societies, patient advocacy groups, and many leading health insurance plans.

There were a number of challenges in putting together these guidelines, according to a CMTP report. One was that some payers voiced concern that the discussion was focusing on standards for the clinical utility of these tests, when questions still persisted about the analytic and clinical validity of NGS testing. Another was about the current lack of evidence of clinical utility, along with the corresponding lack of coverage for even the older methods of genetic and genomic testing.

NGS technology permits the sequencing of large genomic regions, high numbers of genes, and/or high numbers of samples in a single assay that is more efficient, more cost-effective, and more sensitive than traditional techniques. However, the panels can provide information on genetic mutations that are of unclear clinical significance or that would not lead to changes in patient management.

Finally, discussions of standards for the clinical utility of this technology tend to focus on evidence that individual variants or gene mutations can be used in a specific clinical context, but do not directly address the larger question of how to evaluate the clinical benefits and risks of panels or other NGS-based testing approaches that analyze many different genes and variants at one time.

Key Recommendations

The draft guidelines include:

  • a consensus recommendation for payers to cover NGS panels of five to 50 genes when those panels include a subset of constituent genes that are considered to be standard-of-care and medically necessary for the patient

  • a recommendation for payers to rely on the College of American Pathologists (CAP) accreditation program and proficiency testing to ensure the analytic validity of NGS

  • a proposal for payers to cover the larger and more comprehensive NGS cancer panels with preauthorization under circumstances of extenuating medical need

  • proposals that would incentivize laboratory and clinician sharing of data, that would promote patient participation in clinical trials and registries, and that would support robustly designed well-curated data repositories and clinical research initiatives.

"NGS testing methods are potentially important new tools to enable clinical genomics and the realization of personalized medicine," said Donna Messner, PhD, vice president and senior research director at CMTP, who was involved in the development of the draft guidelines. "However, there is currently substantial uncertainty over future health plan coverage policy for genomics and how to accelerate evidence development for this testing, which we hope to clarify through this effort," she said in a statement.

The next phase of these guidelines will begin in the Fall, and will include seeking broader public comment and input, meeting with stakeholders (including the CAP), discussing ways to make the CAP NGS accreditation program more useful to payers, and meeting with major payers (such as the CMS, the US Food and Drug Administration, and pharmaceutical companies) to discuss potential policy options for covering NGS-directed off-label use of targeted cancer therapies under certain circumstances.

There will also be discussions about incentivizing data-sharing, clinical trial participation, and systemic real-world data collection that will enable improved interpretation and clinical utility of gene variant information.

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