Epigenomics AG will challenge CMS’ decision by either appealing or bringing some form of litigation.
In October 2020, CMS created a guideline for blood-based tests to earn NCD approval. In its most recent decision, CMS eliminated a condition that would require the test to be recommended by a professional society guideline, consensus statement or U.S. Preventive Services Task Force recommendation, according to a SeekingAlpha report.
CMS did retain a portion of the guideline that relates to sensitivity and specificity. CMS will only cover a test with a sensitivity of at least 74 percent and a specificity of at least 90 percent.
Greg Hamilton, Epigenomics AG CEO, previously took issue with this portion of the guideline. He said in a release, “Randomly selecting sensitivity, specificity and testing interval values from various tests and assuming it will reduce CRC Mortality is not the appropriate way to make evidence-based care decisions.”
Many people view the guideline as favoring in-development tests by Exact Sciences and Guardant Health. On the news of CMS’ decision, stocks for both companies increased 1.6 percent and 1.1 percent, respectively, SeekingAlpha reports.
More articles on surgery centers:
Ohio health system acquires surgery center for $21M
2 Texas health systems suspend surgeries, others don’t
Stryker’s ASC-focused business: 3 things to know
At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.
