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January 27, 2020 - Today, the Centers for Medicare and Medicaid Services released its final National Coverage Determination (NCD) on next-generation sequencing (NGS) for Medicare beneficiaries. The policy paves the way for national coverage of tumor/biomarker testing and multigene panel testing for hereditary cancer under specific circumstances. It also allows for local Medicare regions to establish policies for NGS-based testing for hereditary cancer mutations.
The NCD is the result of a two-year effort. In late November, numerous organizations joined us in submitting comments urging substantive changes to the policy. We met with staff from the Medicare Coverage and Analysis Group to discuss our concerns on January 16. The final policy shows that the majority of our concerns were heard.
Nationally covered services include:
Somatic/Tumor Testing - when the patient has:
The diagnostic laboratory test using NGS must have:
Multigene Testing for Hereditary Cancer - when the patient has:
The diagnostic laboratory test using NGS must have all of the following:
The policy also allows the MACs to develop Local Coverage Determinations (LCDs) for NGS-based hereditary cancer testing for patients with any type of cancer who meet specified criteria. This is important because currently, there are no FDA-approved or -cleared tests for hereditary cancer (germline) gene mutations. As such, coverage will fall to the MACs.
See the "Advanced Reading" tab for further background on this policy.
FORCE supports genetic testing for all Medicare beneficiaries who have a known mutation in their family or meet established guidelines for hereditary cancer risk assessment. Beneficiaries without a personal history of cancer have never qualified for coverage of genetic testing under Medicare because the program is very specific about the preventive services it provides. We would like to change this.
We are working to introduce federal legislation aimed at changing the Medicare statutes to allow for genetic counseling, testing, and related evidence-based preventive and risk-reducing services for anyone who meets national guidelines—survivors and previvors.
Check back for updates on our efforts around this important issue...
In late 2017, the Centers for Medicare Medicaid Services (CMS) issued a “Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer.” We submitted comments in January 2018 and the National Coverage Determination (NCD) was finalized in March 2018. All indications were that the policy only applied to genomic tumor (somatic) testing, which is very different from hereditary (germline) testing. However, on November 30, 2018, CMS released guidance that clarifies the rule, ultimately eliminating coverage of germline tests except in advanced cancer settings where the patient is seeking further treatment. Medicare is comprised of about a dozen local regions managed by the Medicare Area Contractors (MACs); these tests have historically been covered by local coverage determinations (LCDs). National policies take precedence over local policies.
In January 2019, we coordinated a stakeholder letter to Seema Verma, Administrator of CMS, signed by over 60 patient advocacy groups, health professional organizations, labs and other industry groups explaining why this interpretation of the NCD is faulty. A press statement further elucidated the issue.
In February 2019, FORCE organized a group of stakeholders representing patient and health care professional organizations, and met with the leadership of Medicare’s Coverage and Analysis Group (CAG) to discuss application of the NCD for Next Generation Sequencing (NGS) to hereditary cancer genetic testing in addition to tumor (somatic) testing. See our blog on the meeting.
CMS ultimately opened the policy for reconsideration and in May 2019, over two dozen organizations joined FORCE in submitting comments outlining concerns and urging changes. Unfortunately, the resulting proposal falls significantly short of providing reasonable and necessary care.