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Industry Collaboration Win: CMS Reviewing National Coverage Determination on Next Generation Sequencing Panels for Cancer Risk

  • Rina Wolf

The Centers for Medicare & Medicaid Services (CMS) has agreed to revisit the national coverage determination (NCD) on next-generation sequencing (NGS) panels to address concerns about the impact of the current policy on patients and their ability to affordably access testing for hereditary cancer risk.

This is an accomplishment of industry collaboration. Laboratories, specialty groups, and patient advocacy organizations came together to voice concerns that the NCD failed to take into consideration how physicians use these tests in clinical practice as part of the current standard of care to help treat patients diagnosed with earlier stages of disease. The community’s request was that CMS reopen this discussion to ensure that as an industry we are aiding the majority of patients who can benefit from the advantages of NGS panels.

As reported in GenomeWeb on March 27, this discussion started earlier this year when one Medicare contractor, at CMS’ direction, revised a local coverage determination (LCD) to restrict coverage for NGS panels for BRCA1 and BRCA2 for patients with early-stage disease. According to GenomeWeb:

Rina Wolf, Vice President Commercialization Strategies, Consulting & Industry Affairs, XIFIN

Medicare contractors historically have covered such tests for patients who already had cancer but didn't limit testing depending on cancer stage. Knowledge of one's genetic risk for cancer is most useful for guiding prevention strategies if this information is known earlier in the disease trajectory.


Subsequently, 60 different organizations, including the American Clinical Laboratory Association (ACLA), contacted CMS to articulate the concerns of limiting the value of NGS panels to those with late-stage breast and ovarian cancers. The industry presented a united front on this issue, and as a result, CMS has agreed to revisit the NCD.

Industry Collaboration Works

This success underscores the power of the collective group’s focus on ensuring CMS decisions consider the advice and guidance of clinical experts. Although CMS has an agreement to reopen this discussion, it is still moving forward with the implementation of the revised LCD on BRCA testing, scheduled for April 8th. Unfortunately, the announcement, made by the Director of the CMS Coverage and Analysis Group, Tamara Syrek-Jenken, at the ACLA annual meeting last month, did not include any details as to the timing and logistics of the additional review. 

The important thing to keep in mind is that if laboratories, specialty societies, and patient advocacy groups continue to work together with a common goal of providing patients with affordable access to the right tests to answer diagnostic questions and determine appropriate treatment plans in a timely manner, patient outcomes will continue to improve. There is no doubt that these are complex issues and only by tapping appropriate expert clinical resources can we make the best decisions for the industry and patients alike. It is important that coverage determinations are reflective of the constantly changing best practices in real-world clinical care. I believe that CMS agreeing to revisit this NCD is the right decision for patients, and I’m pleased that CMS issued a statement that this is something that they will address promptly. Every day that goes by without access to NGS panels for early-stage breast and ovarian cancer patients puts lives at risk.

If you want to read more on the evolving policy structure for genomic medicine, Bruce Quinn has written an excellent white paper on “How the CMS NCD for Oncology Genomics Went Sideways: 2017-2019.”

To stay up to date on these and other important industry changes, subscribe to The Billing Beat, XIFIN’s curated monthly newsletter.

Published by XIFIN
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