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The Medicare contractor said in its draft guidance it would provide limited coverage for the cell-free DNA assay, which should be used as a supplemental test.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.
The agency said its aim is to analyze the way CMS has chosen to implement PAMA and to estimate the potential financial impact to Medicare as a result of those choices.
After a GAO report found that CMS may be overpaying for lab tests, the legislator is asking the government payor to explain how it will ensure appropriate use of taxpayer funds.
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.
Smaller labs that serve large Medicare populations, such as skilled nursing facility labs, have cut services and expressed concerns about their survival.
New drugs, tests, and policies suggest steady and continued future growth in the space, though public awareness of personalized medicine continues to lag.
The group recommends Myriad Genetics' EndoPredict, NanoString's Prosigna, and Genomic Health's Oncotype DX tests for guiding chemotherapy decisions if certain conditions are met.
