Healthcare Stakeholders Ask CMS Not to Limit Access to NGS Hereditary Cancer Risk Tests

NEW YORK (GenomeWeb) – A group of 60 diverse healthcare companies and organizations has written to the Centers for Medicare & Medicaid Services, requesting the agency change its decision to restrict coverage of next-generation sequencing-based testing for hereditary cancer risk.

In early January, Medicare contractor Palmetto updated a local coverage decision for BRCA1 and BRCA2 testing to align with CMS' national coverage determination for NGS testing for advanced cancer. That NCD was triggered by Foundation Medicine's bid to garner regulatory approval and national coverage for FoundationOne CDx, an NGS test that analyzes tumor samples for mutations in hundreds of genes in order to personalize cancer treatment. CMS agreed to cover this and similar tests for patients with recurrent, relapsed, refractory, metastatic, or advanced stage III or IV disease who are seeking treatment. 

Aligning local coverage for NGS germline testing for cancer risk mutations with a national policy largely designed for NGS somatic testing means that early-stage cancer patients will not be covered for hereditary cancer risk testing. Some have estimated that approximately 60 percent of cancer patients have stage I or II disease. 

"We believe that the new interpretation will restrict patients’ access to medically necessary and relevant testing of germline mutations in cancer patients and will adversely impact cancer patients’ care and outcomes," the 63 organizations stated in the letter, addressed to CMS Administrator Seema Verma. 

Stakeholders have pointed out that somatic mutation testing is largely for informing treatment while germline testing is for assessing the risk of cancer, though information about germline BRCA mutations can also inform breast and ovarian cancer treatment in advanced patients. The NCD criteria should not comprise germline NGS testing, they argue, because knowledge of cancer risk is most beneficial for early-stage patients when the results can inform preventive strategies to avoid advanced disease, relapse, or recurrence later on, as well as testing of family members who might be at risk. 

"It is our understanding that despite the NCD being requested for a somatic-based test, CMS has instructed Medicare Administrative Contractors to apply the terms of the NCD to both somatic and germline NGS-based testing for patients with cancer," the letter states. "The implication of this interpretation is both germline and somatic tumor NGS-based testing will become non-covered for Medicare beneficiaries with early-stage cancer." 

Initially, only Palmetto incorporated language in an LCD to restrict germline NGS testing coverage for early-stage cancer patients. But since then, at least one other Medicare contractor, Noridian, has included similar language in an updated LCD for BRCA1/2 testing. 

The diversity of the organizations that have signed the letter to CMS demonstrate widespread concern over this policy. The signees including trade groups, like the Association for Molecular Pathology, AdvaMedDx, the American Clinical Laboratory Association, as well as the Personalized Medicine Coalition. Numerous cancer and patient advocacy groups have signed the letter, too, including the American Society of Clinical Oncology, Bonnie J. Addario Lung Cancer Foundation, Facing Our Risk of Cancer Empowered, Susan G. Komen, and Sharsheret. 

Julie Khani, president of ACLA, told Verma that "it is essential that CMS unequivocally maintain coverage for medically necessary NGS-based tests." 

Also adding their names to the letter are large reference labs, including the Laboratory Corporation of America, Quest Diagnostics, BioReference Laboratories; NGS platform providers Illumina and Thermo Fisher Scientific; genetic testing providers Myriad Genetics, Invitae, and Ambry Genetics; and personalized medicine-focused healthcare providers, such as Intermountain Precision Genomics and Columbia University Irving Medical Center. 

A number of organizations have also written separately to Verma to relay similar worries. The Society for Women's Health Research expressed its concerns that the agency’s broad interpretation of the NCD will negatively affect women and inhibit investment in women’s health innovations. "This rendering also is counter to the primary goals of personalized medicine and public health," wrote SWHR CEO Amy Miller. 

These companies and groups pointed out that Medicare contractors have long had LCDs that provide coverage for germline genetics testing, including via NGS panel testing, and that this has been an important covered benefit for beneficiaries with hereditary breast and ovarian cancer syndromes and Lynch syndrome. To take away these established benefits would be a "significant policy overreach," the 60 organizations wrote. 

CMS made this coverage change, which could have such broad impact, without granting stakeholders a notice and comment period and without any discussion of this in the original NCD. "Consequently, only tests utilizing older, less-advanced, and more expensive non-NGS methods will be eligible for Medicare coverage," the letter states. Most labs have transitioned away from using older technologies like Sanger sequencing and now use NGS panels to assess hereditary cancer risk. 

"Rather than creating additional barriers, we urge CMS to consider the collective comments from this diverse community of health care organizations and reinstate coverage for these medically necessary hereditary cancer tests," Mary Williams, executive director of AMP, said in a statement.