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.
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.
The Medicare contractor said in its draft guidance it would provide limited coverage for the cell-free DNA assay, which should be used as a supplemental test.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 test is designed to determine which early-stage, estrogen receptor-positive breast cancer patients are likely to benefit from extended endocrine therapy.
Data from the GUIDED study will be central to commercial payor discussions, a Medicare LCD reconsideration request, and eventually expansion into the primary care market.
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.
New drugs, tests, and policies suggest steady and continued future growth in the space, though public awareness of personalized medicine continues to lag.
Dan Rather, the former CBS Evening News anchor and executive producer of a new documentary, writes at the Guardian that everyone needs to know about CRISPR.
In PNAS this week: analysis of FOXA1 upregulation in ER-positive breast cancer, gene editing to correct recessive dystrophic epidermolysis bullosa, and more.
