A private payor survey by ClearView Healthcare Partners found that medical directors viewed CMS's decision with caution; half had no plans to align commercial plan coverage.
Under the draft determination, the test would be covered to help assess which treatments to use in patients with advanced prostate cancer.
The policy states that lab tests without FDA's blessing may pursue local coverage via Medicare contractors, but national coverage requires premarket approval or clearance.
The final determination also adds coverage for FDA-approved tests in stage III patients, and for repeat testing if patients receive a new primary diagnosis.
These lobbying efforts aim to shore up willingness among legislators to step in and halt implementation of the NCD if certain provisions remain in the final version.
Interpace said that its two thyroid tests are now covered for over 280 million patients nationwide including Medicare, Medicare Advantage, and national and regional health plans.
A perspective that hasn't gotten as much attention is that the CMS draft coverage decision could be bad for patients by increasing off-label drug use based on the results of NGS panels.
The payor has agreed to cover Interpace's ThyGenX and ThyraMir, for thyroid nodules deemed indeterminate by standard cytopathological analysis.
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.
Researchers in the UK and Australia uncover genetic links between BMI and depression, the Guardian reports.
The Verge details the account of an academic who alleges her university retaliated against her after she complained of sexual harassment by her supervisor.
The New York Times writes that natural history museums are helping round out genetic studies with older specimens.
In PNAS this week: artemisinin resistance mutations in malaria parasites, ant-plant interactions over time, and more.