FDA

Case of the Month: FDA Issues Warning Letter for Unapproved Changes to Approved Assay

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. So, when the product undergoes significant changes, it often triggers … [Read more...]

FALSE CLAIMS

Enforcement Trends: Feds Targeting Commercial & Private-Pay, Not Just Medicare Fraud

Risk of federal prosecution for health fraud and abuse applies only when you deal with Medicare, TRICARE or other federal health programs. Right? Wrong! While that used to be true, the times they … [Read more...]

ENFORCEMENT

Case of the Month: Milwaukee Clinic the Latest MD-Owned Lab Busted for Urine Drug Test Abuses

Fraudulent utilization and billing of urine drug screening has become a priority for federal enforcers since the $256 million Millennium settlement of 2016. Subsequent cases have targeted abuses … [Read more...]

OIG

Medicaid Fraud Enforcement Trends By the Numbers

A new report from OIG details Medicare Fraud Control Unit (MCFU) enforcement activity in fiscal year 2018. Bottom Line on Top: The numbers were pretty consistent with previous trends with little in … [Read more...]

ENFORCEMENT

From Blood Screen to Silver Screen: The Theranos Story Goes Hollywood

Clinical labs are not usually the stuff of Hollywood. But the story of Theranos and its charismatic leader has attracted filmmakers the way regular law-abiding labs never do, spawning not one but a … [Read more...]

COMPLIANCE

Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory

By Danielle Sloane¬†bio and Elaine Naughton¬†bio Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests … [Read more...]

DRUG TESTING

Enforcement Trends: CMS Looks to Recover $66.3 Million in Improper Specimen Validity Test Payments

The opioid crackdown has made urine drug testing an even greater priority for federal health fraud enforcers. One principle target is specimen validity testing (SVT) billed in combination with urine … [Read more...]

HIPAA

Enforcement Trends: Record Breaking Year for HIPAA Fines

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 $28.7 million in fines, easily surpassing the old … [Read more...]

COMPLIANCE

Enforcement Trends: After 2017 Decline, False Claims Act Healthcare Recoveries Bounce Back

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 healthcare sector. But that short-term trend could be in … [Read more...]

ENFORCEMENT

New Law: EKRA Makes Drug Addiction & Rehab Labs Potential Targets for Federal Prosecution

Recent federal legislation addressing the opioid crisis may have unintended consequences on the lab industry. The idea was to allow the feds to prosecute a certain kind of abuse banned by the … [Read more...]


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