CMTP Press Release:
Collaborative Issues Initial Guidelines for Health Insurance Coverage of Next Generation Sequencing (NGS) Testing in Oncology
Multi-stakeholder group recommends coverage for NGS panels of 5-50 genes (including all standard of care genes); 23 pages; online here.
Press release after the break.
Baltimore, MD (August 17, 2017)
The Center for Medical Technology Policy (CMTP) has released initial health insurance coverage guidelines for Next Generation Sequencing based testing in Oncology (look for PDF here). The draft guidelines, which are now available for public comment, were developed by CMTP's Green Park Collaborative, (GPC), through a multi-stakeholder process that includes NGS testing and technology companies, medical professional societies, patient advocacy groups, and many of the nation's leading health plans.
"NGS testing methods are potentially important new tools to enable clinical genomics and the realization of personalized medicine," said Donna Messner, Vice President and Senior Research Director, who led the GPC guideline development effort. "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."
"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, the CEO of CMTP and a former Chief Medical Officer for the Center for Medicare and Medicaid Services (CMS). "Getting agreement on guidelines for coverage of targeted NGS gene panels is a crucial first step towards more comprehensive and forward-looking policies for genomics in clinical medicine."
The initial draft NGS coverage guidelines include:
1. A consensus recommendation for payers to cover NGS panels comprising between 5 and 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; 2. A recommendation for payers to rely on the College of American Pathologists (CAP) accreditation program and proficiency testing to assure the analytic validity of NGS; 3. A proposal for payers to cover larger, more comprehensive NGS cancer panels with preauthorization under circumstances of extenuating medical need; and 4. Proposals to incentivize laboratory and clinician sharing of data, to promote patient participation in clinical trials and registries; to support robustly designed, well-curated data repositories as well as clinical research initiatives such as the Medical Evidence Consortium (MED-C), the American Society for Clinical Oncology’s (ASCO) TAPUR study and others.
The release of this recommended coverage policy framework concludes the initial phase of GPC's efforts in this topic area.
The next phase of work for the Green Park Collaborative, which commences in the fall of 2015, will include:
1. Seeking broader public comment and input on this initial coverage policy framework; 2. Meetings with College of American Pathology (CAP), CMS, Palmetto, major payers, and other stakeholders to discuss ways to make the CAP NGS accreditation program more useful to payers; 3. Meetings with major payers, CMS, FDA, and pharmaceutical companies to discuss potential policy options for covering NGS-directed off-label use of targeted cancer therapies under certain circumstances; 4. Discussion of options to incentivize data-sharing, clinical trial participation and systemic, real-world data collection to enable improved interpretation and clinical utility of gene variant information; and 5. Discussion of conditions under which comprehensive NGS cancer panels (larger than 50 genes), as well as whole genome and whole exome sequencing panels may be covered.
About the Green Park Collaborative
GPC, a major initiative CMTP, is a multi-stakeholder forum that was established to guide the generation of clinical evidence needed to inform healthcare treatment and coverage decisions in the United States. GPC members include a diverse mix of payers, life sciences companies, patients, clinicians, researchers, and regulators. GPC convenes working groups to develop condition and technology-specific study design recommendations that focus on real-world effectiveness and value, meet the evidence expectations of payers, and are informed by the views of patients and clinicians.
For additional information: