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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Turning Whistleblower Lemons into Compliance Lemonade
A False Claims Act whistleblower lawsuit can do significant damage to your lab and its reputation, even if the case lacks truth and merit.
Medicaid Fraud Recoveries Drop Significantly in 2022
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
Congress Offers New Hopes of PAMA Reform
On March 28, the 118th Congress raised lab industry hopes once more by reintroducing the Saving Access to Laboratory Services Act (SALSA).
OIG OKs Offering Patients Gift Cards for Returning At-Home Test Kits
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.
SCOTUS to Decide Monumental Question Affecting Providers’ FCA Liability
It’s not just billions of dollars on the line, but the very future of whistleblower lawsuits and FCA enforcement.
FCA Enforcement Activity Is Up but Recovery Dollars Are Down
The DOJ’s recent report on FCA enforcement statistics for FY 2022 shows that while actions are dramatically up, recoveries are way down.
OTC COVID-19/Influenza Test Approval Comes Too Late to Save Lucira Health
No company better embodies the vicissitudes of running a COVID-19-focused diagnostics business during the pandemic period than Lucira Health.
FDA Keeps COVID-19 EUA Pipeline Open While Working toward Transition
HHS secretary takes action to ensure that EUAs remain in effect until the “significant potential” for a COVID-19 PHE no longer exists.
Lab Companies Turn to Product Integrations to Cut Costs, Risks, & Time
Product integration collaborations have become increasingly common, with five such deals being announced between February and mid-March.
Med-Tech Startups Survive SVB Collapse but Face New Concerns
While only time will tell how bad the ultimate damage turns out to be, it appears for now at least that the industry has dodged a bullet.
