An assessment concluded that Oncotype Dx has not demonstrated a significant enough impact on outcomes or cost effectiveness compared to current practice.
Several of the top molecular diagnostic firms presented at the JP Morgan Healthcare Conference on Monday discussing product portfolios, FDA clearances, and plans for 2018.
Companies in the life science tools and molecular diagnostics spaces provided updates on their businesses at the 36th annual JP Morgan Healthcare Conference this week in San Francisco.
Some industry players are accusing CMS of advancing backdoor LDT regulation by proposing to cover NGS tests with FDA approval/clearance, except in a limited setting.
This is Biocept's third BCBS contract and enables cancer patients to access the company's testing services in network under their Wellmark health plans.
The investment bank said that an edit to CMS guidelines impacts payments for hereditary cancer testing, and could present Myriad with revenue and EPS headwinds.
The government payor made some adjustments in finalizing the 2018 clinical lab fee schedule, but the industry continues to feel CMS is ignoring its most salient concerns.
The agency is excluding certain advanced diagnostic lab tests and molecular pathology tests from a billing regulation that created administrative headaches for many labs.
Anthem said the automated system is an efficient way to ensure coverage for medically necessary genetic tests, but that's not what genetic counselors have described.
Since last year the AMA has issued 23 PLA codes for firms that want to better track use of their tests, but the effect of the codes on improving reimbursement remains to be seen.
