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.
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.
ACLA alleges that HHS and CMS interpreted the Protecting Access to Medicare Act in a way that resulted in 2018 payment rates that are much lower than Congress intended.
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 final guidance is an update to an agreement between the FDA and CMS, which uses the FDA's policy in determining coverage for investigational devices.
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 US Attorney's Office, District of New Jersey said the cardiologist and his wife operated a test-referral bribery scheme with Biodiagnostic Laboratory Services
Ahmed El Soury was sentenced for his role in a scheme perpetrated by now-defunct Biodiagnostic Laboratory Services to bribe doctors in return for testing referrals.
