ENFORCEMENT

Case of the Month: $33.2 Million Alere Settlement Sends Warning Shot Across Bow of LDT & DX Device Makers

One of the reasons Abbott Laboratories got cold feet about consummating the $5.3 billion Alere acquisition was concern over the legal proceedings against the target firm. Now one of those cases … [Read more...]

COMPLIANCE

Physician Referrals: New Rules Offer Some Stark Law Relief but Not Nearly Enough

Like most budget bills, the new federal Bipartisan Budget Act of 2018 includes a number of changes to Medicare fraud and enforcement requirements. One set of changes affects the current physician … [Read more...]

FOCUS ON

New Laws: Very Quietly, Congress Doubles Penalties for Medicare Fraud & Abuse

Sneaky may be too strong a word. But what is fair to say is that the new hikes in federal health care fraud violation penalties have flown totally under the radar despite their obvious and immediate … [Read more...]

OPIOIDS

Enforcement Trends: Labs Getting Swept into the Opioid Crackdown Vortex

Best known for its employment applications, urine drug testing is also medical protocol for patients prescribed opioid drugs. Urine tests are used to ensure patients are not developing addictions and … [Read more...]

FOCUS ON

DOJ to Prosecutors: Show Tough Love to Whistleblowers with Weak Cases

A newly leaked internal Justice Department memo signals a new prosecution policy that may make it harder for whistleblowers to bring qui tam whistleblower lawsuits under the False Claims Act (FCA). … [Read more...]

ENFORCEMENT

EHR: Private Whistleblowers Getting in on “Meaningful Use” Crackdown

Wrongful payment of electronic health records (EHR) "meaningful use" incentives has become a growth area in federal health care fraud enforcement. And now private whistleblowers are getting … [Read more...]

COMPLIANCE

Labs Figure Prominently in OIG’s Newest Top 10 Challenges List

Although the OIG has its flaws, lack of transparency is not among them. Exhibit A: the agency's ongoing list of top 10 management and performance challenges facing the Department of Health and Human … [Read more...]

QUALITY OF CARE

New Lawsuit Tests Limits of Medical Malpractice in Age of Precision Medicine

Is a health care provider's failure to refer a cancer patient for genetic counseling grounds for medical malpractice? One patient claims it is and wants $1.8 million in damages because she never … [Read more...]

ENFORCEMENT

Enforcement Trends: 5 Takeaways from OIG’s New Semiannual Report

Veteran OIG semiannual report aficionados will find little in the most recent edition to distinguish it markedly from its predecessors. But while a new administration has done little to change the … [Read more...]

PRECISION MEDICINE

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

Using Nuclear Stress Tests as Screening Procedure = Medical Necessity Violation Case: A California cardio clinic and its physician owners will pay $1.2 million to settle charges of falsely billing … [Read more...]


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