Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Weekly Enforcement Report: Unlicensed Professionals
Last week’s lone lab-related enforcement action involved a prison sentence for a woman posing as a licensed physician’s assistant.
FCA Recoveries Decline despite Increase in Enforcement Activity
The DOJ's 2022 Fraud Statistics Overview shows it raked in less than 50 percent of what it recovered in FY 2021.
Illegal Marketing Commissions Arrangements Cost Toxicology Lab $5.9 Million
Recent case shows that toxicology labs and drug testing remain a primary target for federal enforcement agencies.
Senators to HHS: Keep Covering At-Home COVID-19 Tests After PHE Ends
Group of 18 senators says ending Medicare coverage for at-home COVID-19 tests would undo efforts to contain spread of the coronavirus.
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.
Medical Device Executives Nailed with Fraud Charges
The three Magellan Diagnostics executives are accused of FDA violations, as well as wire fraud and conspiracy.
Theranos’ Holmes Won’t Avoid Jail While Her Appeal Is Pending
On Monday, federal Judge Edward Davila denied the disgraced Theranos CEO’s motion to remain free while she appeals her conviction.
