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
Enforcement-nir
Subscribe today for access to
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
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.
Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
Enforcement Trends: CMS Looks to Recover $66.3 Million in Improper Specimen Validity Test Payments
From - National Intelligence Report
The opioid crackdown has made urine drug testing an even greater priority for federal health fraud enforcers. One principle target is specimen validity testing…
Enforcement Trends: Record Breaking Year for HIPAA Fines
From - National Intelligence Report
The federal Office for Civil Rights (OCR) reports that 2018 was a record year for HIPAA enforcement, with 10 settlements and one judgment bringing in…
Enforcement Trends: After 2017 Decline, False Claims Act Healthcare Recoveries Bounce Back
From - National Intelligence Report
Although the False Claims Act (FCA) remains a federal enforcement cash cow, the growth rate has fallen off in recent years, at least in the…
Already a member? Log in here
Already a member? Log in here
Feds Continue Roundup of Physicians on Receiving End of Millennium Labs Test Cups Freebie
From - National Intelligence Report
The Millennium Laboratories free point of care test (POCT) cups scandal has been described as the biggest kickback scandal involving…
Florida Doctor Jailed 5 Months for Lying to a Medicare Auditor
From - National Intelligence Report
Lying to a Medicare auditor or otherwise obstructing a Medicare audit is a crime that can get you jailed…
Case of the Month: Fraud or Legitimate Rural Hospital Lab Outreach Business?
...
Already a member? Log in here
Case of the Month: Alabama Hospital Lab Settles Data Breach Class Action Suit
From - National Intelligence Report
Class action lawsuits by patients victimized by data breaches have become increasingly common. And, more often than not, they prove unsuccessful…