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
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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.
The Year in Labs Regulation: The 6 Biggest Stories of 2019
"May you live...
Enforcement Actions: Doctors Pay $1.1 Million to Settle Genetic Test Kickback Claims
From - National Intelligence Report
Kickbacks for genetic test referrals has become a focus of recent federal enforcement action. The most recent case involves…
Enforcement Trends: Investment Return on Fraud Fighting Continues to Decline
From - National Intelligence Report
Although it's still a profitable endeavor, enforcing federal health care fraud laws isn't providing the investment returns of yesteryears…
DOJ Explains What It Wants from a Compliance Program
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New OIG Report Confirms that Labs Are Still on the Enforcement Radar
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Case of the Month: FDA Issues Warning Letter for Unapproved Changes to Approved Assay
From - National Intelligence Report
As a rule of thumb, FDA approvals are a snapshot applicable only to the product as it exists at the time of review and approval…
Enforcement Trends: Feds Targeting Commercial & Private-Pay, Not Just Medicare Fraud
From - National Intelligence Report
Risk of federal prosecution for health fraud and abuse applies only when you deal with Medicare, TRICARE or other federal health programs…
Case of the Month: Milwaukee Clinic the Latest MD-Owned Lab Busted for Urine Drug Test Abuses
From - National Intelligence Report
Fraudulent utilization and billing of urine drug screening first became a priority for federal enforcers since the…
Medicaid Fraud Enforcement Trends By the Numbers
From - National Intelligence Report
A new report from OIG details Medicare Fraud Control Unit (MCFU) enforcement activity in fiscal year…
From Blood Screen to Silver Screen: The Theranos Story Goes Hollywood
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