No Signs of the DOJ Letting Off the Pedal with Medicare Fraud Investigations
However, a new memo instructs federal prosecutors to ‘avoid overreach’ when parties cooperate with authorities
National Lab Reporter
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Articles and Reports
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
LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
Inside the Lab Industry: Q2 Earnings Decline Despite Rebound in Core Business
Though COVID-19 testing declines continue to negatively affect lab industry profits, the latest figures suggest the worst may be over.
October 2023 Labs in Court
Recent cases involve charges and judgments related to COVID-19 add-on tests, genetic testing fraud, and kickbacks.
OIG Sheds Light on Kickback Implications of Online Healthcare Directories
Recent advisory opinion offers insight on how healthcare providers may want to structure arrangements involving online directories.
Enforcement Trends: OIG Calls Out CMS for Not Preventing Medicare Genetic Testing Overpayments
Inadequate CMS oversight resulted in $888.2 million in improper payments for the highest reimbursing molecular pathology genetic tests, report says.
Medicare Reimbursement: CMS Proposes to Cut Part B Payments to Physicians
The proposed PFS rule also includes other changes that will affect physician, lab, and other reimbursements in 2024 and beyond.
New CMS TCET Rule Likely Won’t Hasten Medicare Coverage of Breakthrough Devices
Recently proposed rule seems too stringent to reduce the lag between FDA approval and Medicare coverage.
CMS Provides New Guidance on When International Labs Must Seek CLIA Certification
Recently released Centers for Medicare and Medicaid Services guidance shares when CLIA regulations apply to international labs.
Congress Moves to Require Medicare Coverage of Multi-Cancer Early Detection Tests
Federal lawmakers have renewed efforts to pass legislation ensuring Medicare coverage of multi-cancer early detection (MCED) tests.
Whistleblowers: SCOTUS Gives DOJ Wider Authority to Dismiss Meritless Qui Tam Cases
Ruling could spell good news for labs and other healthcare providers targeted by whistleblowers in False Claims Act qui tam lawsuits.
Enforcement Trends: The Urine Drug Testing Crackdown and Three Ways to Avoid It
False billing of urine drug tests (UDTs) continues to be a focus for enforcement agencies in 2023, here’s how to avoid compliance issues.
