FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
Keeps You Up-to-Date on Federal & State Laws, Regulations, New Legislation, and Court Cases that Affect Your Diagnostic Lab or Pathology Practice
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
CMS recently issued long-awaited guidance on post-PHE changes to Medicare coverage of SARS-CoV-2 diagnostic tests.
An overview and analysis of the recently proposed changes and how they could affect your medical laboratory.
Recent case shows why failing to disclose to individuals the lab test list prices they may need to pay doesn’t count as consumer fraud.
At $1.1 billion, total recoveries in 2022 did exceed $1 billion for the fourth year in a row, but dropped from $1.7 billion in FY 2021
On March 28, the 118th Congress raised lab industry hopes once more by reintroducing the Saving Access to Laboratory Services Act (SALSA).
A new OIG Advisory Opinion sheds some light on when it’s permissible for a lab to offer customers a gift card for returning their at-home testing kit.
It’s not just billions of dollars on the line, but the very future of whistleblower lawsuits and FCA enforcement.
The DOJ’s recent report on FCA enforcement statistics for FY 2022 shows that while actions are dramatically up, recoveries are way down.
Resolution process put on hold after federal court again strikes down parts of the regulation as being unfairly weighted in favor of insurers.
Hopes are high that something will finally be done to resolve the LDTs situation this year, however that action may not come from Congress.