In Brief: OIG Opens Second Avenue for Anti-Kickback Statute Revisions

Even as we wait for the second draft of the proposed new value-based kickback relief rules—see National Intelligence Report (NIR), Nov. 15, 2019—the OIG issued its annual call for recommendations for … [Read more...]

ENFORCEMENT

Enforcement Trends: Increase in OIG Fraud Recoveries Belies Continued Decline in Enforcement Actions

OIG fraud recovery has been a solid growth business for nearly two decades. So, when the agency announced a decline in FY 2018 recovery figures, it was more than a bit surprising. But things got back … [Read more...]

OIG

Scorecard: OIG Enforcement Actions against Labs in 2019

Labs remain at the top of the OIG’s enforcement hit list, as illustrated by the number of cases involving labs cited in the agency’s new Semiannual Report to Congress for FY 2019: False Billing … [Read more...]

NEWS

The Year in Labs Regulation: The 6 Biggest Stories of 2019

"May you live in interesting times.” This ancient Chinese curse extolling the virtues of stability may resonate with those of you who work in the lab industry and have a stake in federal … [Read more...]

ENFORCEMENT

Enforcement Actions: Doctors Pay $1.1 Million to Settle Genetic Test Kickback Claims

Kickbacks for genetic test referrals has become a focus of recent federal enforcement action. The most recent case involves three doctors and a cardiology practice that allegedly accepted bribes from … [Read more...]

ENFORCEMENT

Enforcement Trends: Investment Return on Fraud Fighting Continues to Decline

Although it's still a profitable endeavor, enforcing federal health care fraud laws isn't providing the investment returns of yesteryears. That's the main takeaway of the new joint HHS and … [Read more...]

COMPLIANCE

DOJ Explains What It Wants from a Compliance Program

While it may not prevent all violations, the right compliance program can help your lab get lighter penalties if things go wrong. But what exactly is "the right compliance program." On April 30, the … [Read more...]

COMPLIANCE

New OIG Report Confirms that Labs Are Still on the Enforcement Radar

After a recent dip, OIG enforcement activity has seemingly rebounded, at least in terms of total recoveries. That's the basic punchline from the newly published OIG Semiannual Report to Congress … [Read more...]

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...]


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