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...]

FALSE CLAIMS

Case of the Month: Physicians Come Under Fire for Taking Blood Processing Fee Kickbacks from HDL

Like the tango, it takes two to break the anti-kickback laws: one to offer and pay the kickback and the other to accept it. When a major scheme involving payment of kickbacks for lab testing referrals … [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...]

COURT CASES

Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

Florida Doctor Settles Kickback, False Claims Charges for $911K Case: A Florida doctor settled charges of taking kickbacks for referring patients to Universal Oral Fluid Laboratories, a … [Read more...]

COVERAGE

Medicare Coverage: NGS Testing of Early-Stage Cancer Patients Is Back in Play

The reimbursement outlook for those who provide next generation sequencing (NGS) testing to early-stage cancer of Medicare patients with hereditary risks is far brighter today than it was a few weeks … [Read more...]

COURT CASES

Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

New York Breaks Up Massive $28 Million Medicaid Diagnostics Mill Case: One of the biggest Medicaid diagnostics fraud schemes in recent memory has resulted in multiple convictions, including two … [Read more...]

LAB SAFETY

Changes in hazardous waste management: the Generator Improvement Rule

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio If you haven't heard by now, you should know that the EPA published its Generator Improvement Rule (GIR) in 2016. It is an update to the … [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...]

NEWS

DNA Testing at the Border

The Department of Homeland Security (DHS) is piloting a DNA testing program at the U.S.-Mexico border. The program aims to establish "DNA-based family relationship (kinship) verification to improve … [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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