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...]

SAFETY

Diagnostic danger in the lab: Time to reform how we process orders

By Oleg Bess, M.D.  bio I don't know about you, but I was stunned by the findings from a recent report published by Coverys, a national liability insurer, which I feel should put the entire … [Read more...]

FALSE CLAIMS

Enforcement Trends: Feds Turn Up the Heat on False Billing of Nuclear Stress Tests

While the federal enforcement community has made urine drug testing of opioid drug patients its number one target for lab-related False Claims Act (FCA) charges for the time being, nuclear stress … [Read more...]

MEDICAL NECESSITY

Genetic Testing: Natera Settles Prenatal DNA Testing False Billing Claims for $11.4 Million

Before the opioid crackdown, false billing of genetic tests was the hottest thing in federal fraud enforcement against clinical labs. But while drug testing related to prescription opioids has stolen … [Read more...]

TECHNOLOGY

Tech Wars: Guardant & Foundation Make Sweet Lemonade Out of False Advertising Lemons

In June 2017, Guardant Health sued Foundation Medicine for making false statements about the Guardant360 test in its advertisements for the FoundationACT liquid biopsy genomic profiling test. … [Read more...]

FOCUS ON

Emerging Tests: Medicare to Cover Next Gen-Sequencing Tests for Advanced Cancer

In the PAMA era, there are two salient trends in Medicare Part B lab reimbursements: Sharply lower prices for traditional tests; and Wider coverage of newly emerging tests, including some that … [Read more...]

ANTI-KICKBACK

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

Theranos & Its CEO Settle Stock Fraud Charges with SEC Case: Having settled with CMS, Walgreen's and the Arizona State Attorney General, Theranos has made peace with what may be the scariest of all … [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...]

LAB SAFETY

FDA Watch: Agency Approves DTC Genetic Breast Cancer Test—But Attaches Strings

On March 6, the FDA announced its first ever approval of a direct-to-consumer breast cancer gene test—23andMe's genetic health risk report for detecting BRCA1 and BRCA2 genetic mutations most commonly … [Read more...]


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