FOCUS ON

FDA Says LOINC Coding of IVD Tests Is Voluntary, Not Mandatory

On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro┬ádiagnostic tests. There are four key takeaways for IVD test makers and labs: 1. No Mandatory … [Read more...]

BILLING & CODING

Medicare Reimbursement: CMS Begins Implementing New HOPPS Date of Service Rules for ADLTs & Molecular Pathology Tests

CMS has begun implementing the new rules that exempt advanced diagnostic laboratory tests (ADLTs) and molecular pathology tests from Medicare Hospital Outpatient Prospective Payment System (HOPPS) … [Read more...]

COURT CASES

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

Cancer Center Hit with $4.3 Million HIPAA Fine for Failure to Encrypt Case: The University of Texas MD Anderson Cancer Center was on the wrong end of the fourth largest HIPAA fine ever dished out by … [Read more...]

ACQUISITIONS

Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month

Mid-May to mid-June was the busiest period of the year for diagnostic deal making in terms of both volume and magnitude. Here is a look at the highlights. M&A Dollar value-wise, the biggest lab … [Read more...]

COMPLIANCE

OIG Semiannual Report: Opioid Crackdown Is Making Labs a Prime Enforcement Target Once Again

Once the favorite whipping boy of federal enforcers, labs have been demanding less and less of the OIG's attention in recent years. But the newly published OIG Semiannual Report to Congress (covering … [Read more...]

FALSE CLAIMS

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

Insurer Sues Florida Lab and California Hospital for Toxicology Test Billing Scam Case: Anthem Blue Cross Blue Shield is suing Reliance Laboratory Testing for allegedly conspiring with … [Read more...]

INDUSTRY BUZZ

FDA Watch: Agency Offers a Modicum of Relief on DTC Marketing of Genetic Tests

Last November, the FDA raised eyebrows with a notice for public comment proposing to make it easier to bring new genetic health risk (GHR) assessment tests to market. The message to GHR test … [Read more...]

HEALTH INSURANCE

Industry Buzz: LabCorp and Quest Swept Up in Insurance Contract Partner Swap

Can you imagine Scarlett and Rhett swapping partners with Romeo and Juliet? Something like the laboratory industry equivalent of that scenario took place on May 25 when two of the nation's largest … [Read more...]

CONSUMER FRAUD

The End May Be Near for Theranos & Elizabeth Holmes

Four years ago, Theranos was a $10 billion company poised to turn a breakthrough blood testing technology into a diagnostics dynamo to the tune of $70 billion in annual sales. Today, the company and … [Read more...]

ACCREDITATION

Top of the News: ANDE Rapid DNA Platform First to Win FBI Approval

"Great news! The FBI just called." --Extremely rare phrase almost never uttered except sarcastically One of the very few exceptions to the above principle is ANDE (previously known as NetBio), a … [Read more...]


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