New Medicare rates established under PAMA will cause labs to scale back services, and in some cases shut down, the motion states.
An assessment concluded that Oncotype Dx has not demonstrated a significant enough impact on outcomes or cost effectiveness compared to current practice.
The test was developed by the University of Pittsburgh Medical Center and is marketed in partnership with Sonic Healthcare.
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.
The coverage decision is based on the results of an evidence development study the companies launched last year.
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 suit filed against the acting HHS secretary alleges that a flawed data collection process failed to establish market-based rates.
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.
Payors' demands for clinical utility evidence can be met through greater use of databases and registries, Harold Varmus and Rebecca Eisenberg said.
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.
Smaller labs, hospital outreach labs, and labs servicing high numbers of elderly are thought to face the highest risks.
Piper Jaffray analyst William Quirk said the pricing, which was much higher than expected, will help push CareDx toward profitability.
The biggest losers following the release of the preliminary PAMA rates may be Quest and LabCorp, analysts said today.
The government payor proposed rates that would reduce payment by $670 million, though CMS previously estimated a $390 million cut in 2018.
The study is part of an effort to drive health plan coverage for Exosome's ExoDx Prostate IntelliScore prostate cancer test.
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.
In Science this week: International Wheat Genome Sequencing Consortium publishes the bread wheat cultivar Chinese Spring reference genome, and more.
At his FDA Law Blog, Jeffrey Gibbs discusses FDA's technical assistance for the draft Diagnostic Accuracy and Innovation Act.
The New York Times reports that genetic testing has uncovered unfaithful penguins at a Utah aquarium.
Cancer researcher loses funding under new Wellcome Trust anti-bullying policies, the Guardian reports.