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In issuing a proposed limited local coverage determination for Opko Health's 4Kscore, Novitas changed course from a previously issued non-coverage determination.
Stakeholders discussed last year's decision by Palmetto to deny coverage for large respiratory panels and discussed the way forward for test developers and labs.
The organizations provided a list of genes they believe are informative in treatment of myeloid disorders and suggested several changes to the coverage policy.
The test is designed to determine whether a patient with a pelvic mass is at high risk of having ovarian cancer and should be referred for surgery.
Interpace Diagnostics' ThyGeNext and ThyraMir thyroid cancer assays are now covered for about 2.5 million patients in Philadelphia and Southeastern Pennsylvania.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors for Noridian for the week of 5/24/19.
The diagnostic will now be a contracted service with Anthem Blue Cross of California and 10 of its affiliated health plans.
While the impact on participants' bottom lines remains to be seen, some lab company leaders said they expect to see other payors explore similar plans.
The government payor asked the public to specifically weigh in on the evidence supporting germline testing to assess treatment benefit for patients with hereditary cancer syndromes.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors for Guardant Health, Natera, Transplant Genomics, and More for the week of 4/26/19.
Key test growth drivers in the quarter included tuberculosis, Cardio IQ, drug monitoring, and hemapathology blood cancer testing, "all of which showed revenue growth" in Q1.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors for Prospera, Noridian, CGS, and more for the week of 4/12/2019.
NantHealth CEO Patrick Soon-Shiong said that the company is seeking a fast-track FDA clearance predicated on Memorial Sloan Kettering's 468-gene panel.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.
The Medicare contractor said in its draft guidance it would provide limited coverage for the cell-free DNA assay, which should be used as a supplemental test.
Medicare contractor Palmetto is proposing to expand coverage to ensure that more patients have access to genomic profiling when tissue-based testing is not possible.
CMS had received significant stakeholder feedback that germline NGS testing is not the same as somatic testing, and that the NCD as written would negatively impact patients.
My Gene Counsel's confirmatory testing program is the latest example of how the healthcare system is adapting to consumers' growing appetite for genetic testing.
Palmetto's MolDx has agreed to cover Myriad's MyPath Melanoma to help rule out the disease when the biopsy can't be definitively classified by standard clinical and histopathological characteristics.
The agency said it is sensitive to stakeholder concerns and is working with MACs to adjust claims processing systems.