Both sides have filed competing arguments requesting the judge rule on the case without a trial.
The lab industry's appeal to CMS follows Missouri's Medicaid agency's reduction of lab reimbursements from 100 percent to 80 percent of Medicare rates.
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.
At the ACLA conference this week, FDA Commissioner Gottlieb outlined his vision for the agency in the realm of LDTs.
The new recommendation is a positive for Qiagen and Oxford Immunotec, both of which market interferon gamma-release assays.
US civil surgeons screening immigrants for TB will need to perform an IGRA from Qiagen or Oxford Immunotec, instead of the decades-old tuberculin skin test.
The registry from the American Society for Clinical Pathology aims to eventually collect metrics on how lab services impact patient outcomes.
Lab industry groups hope to change CMS's controversial 2016 decision allowing nurses to perform complex lab tests.
The FDA's draft document noted that it is providing additional clarity to help itself and manufacturers better apply the concepts in a 2003 guidance document.
Lipid panel prices and prices for tests formerly bundled together as automated testing profiles are expected to rise in 2018, but fall in 2019.
Project would be managed by the US Centers for Disease Control and Prevention and would require tests from different manufacturers produce the same results.
ACLA urged the court to reconsider its ruling, arguing that it would be impossible for laboratories to comply with it.
OIG will evaluate data to assess whether PAMA pricing results in market-based rates
With only one test FDA-approved for primary hrHPV screening, groups express concern about feasibility of moving away from co-testing
Smaller labs, hospital outreach labs, and labs servicing high numbers of elderly are thought to face the highest risks.
The biggest losers following the release of the preliminary PAMA rates may be Quest and LabCorp, analysts said today.
Genetic counselors and patient advocates say more people are refusing genetic testing because they're uncertain of how it will impact their insurance.
Project Santa Fe, formed last year by five health system-based labs, aims to share strategies and lab-driven programs for improving patient care with labs in other health systems.
The PHG Foundation's report calls for raising clinician awareness about ctDNA testing technology in order to improve patient access to targeted therapies.
The group is proposing women ages 30 to 65 be screened with cervical cytology every three years or receive testing for high-risk HPV every five years.