Recent MD Labs Ruling Has Implications for Test Requisitions and Commissions
A federal appeals court upheld the idea that clinical laboratories can rely on physician orders to justify medical necessity
Labs in Court-nir
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Articles and Reports
Federal Appellate Decision on EKRA Spells Out How Lab Marketers Can Violate the Law
If clinical lab managers instruct marketing personnel to engage in kickback practices, they also could be held legally accountable
FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
Next Steps: With LDT Final Rule Now Null, Industry Groups Urge Lab Managers and Pathologists to Advocate for Change
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
Labs in Court: Alleged Stark Law Violations Lead to $10m Settlement with DOJ
Other recent legal actions include a self-disclosure settlement and punishment for alleged improper diagnostic test add-ons
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”
Reimbursement: ABN’s Failure to Include List Prices for Denied Lab Tests Is Not Consumer Fraud
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.
Holmes May Get a New Trial on Basis of Witness Tampering
Sentencing has been postponed for one month to explore possible government mishandling of key witness testimony.
Theranos in Court: Jury Finds Balwani Guilty on All 12 Counts
Federal San Jose jury finds ex-Theranos COO guilty of all 10 ten counts of wire fraud and two counts of conspiracy to commit wire fraud.
Alleged Violation of Medicare’s 14-Day Rule Costs Company $2.8 Million
Caris Life Sciences agrees to pay $2.8 million to settle claims that it purposely delayed submitting lab tests to get around Medicare’s 14-day rule.
Ellume Faces Lawsuit for Not Refunding Costs of Recalled COVID-19 Tests
Company involved in recent Class 1 recalls of COVID-19 rapid tests now faces further fallout by not refunding customers for faulty tests.
It Was All Elizabeth Holmes’ Fault, Sunny’s Lawyers Claim
amesh “Sunny” Balwani’s legal team makes the case that Holmes is solely responsible for Theranos misdoings.
Website Ad Doesn’t Bar Qui Tam Suit for Rewards Program Fraud
A new case from the US Court of Appeals for the Ninth Circuit tests how far the public disclosure bar goes.
