By focusing too heavily on family history, the Preventive Services Task Force is missing many opportunities for prevention, patient advocates, industry players, and researchers say.
The agency said it is sensitive to stakeholder concerns and is working with MACs to adjust claims processing systems.
The diversity of the organizations that have signed the letter to CMS demonstrates widespread concern over this policy.
CMS's move to restrict coverage could limit test access for early-stage cancer patients and negatively impact lab revenues.
In a letter to CMS, AMP made a case for crosswalking existing CPT codes for BRCA1/2 testing to codes that more accurately reflect the work required to analyze these genes.
The test is now approved as a CDx for advanced ovarian cancer patients considering Lynparza as a first-line maintenance treatment.
While almost 57,000 labs received Medicare payments for labs performed last year, just three labs received 15 percent of the total Medicare lab payments.
The FDA will consider the companion diagnostic application alongside data for Pfizer's talazoparib in BRCA-mutated advanced breast cancer.
The Center for Genomic Interpretation and NSGC want payors to cover confirmatory testing for patients with positive results from 23andMe's FDA-cleared test.
The funding will be available to members of the Association of Community Cancer Centers, a cancer care provider advocacy group.