COURT CASES

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

Texas Pathology Lab Settles EHR Consulting Kickback Claims for $63.5 Million Case: In 2006, HHS implemented an AKS safe harbor and Stark exception letting non-physician providers pay up to 85% … [Read more...]

COMPLIANCE CORNER

Cybersecurity: The 10 Things HHS Says You Should Be Doing to Stop Phishing, Ransomware and Other Threats

HHS published guidance on cybersecurity for healthcare organizations. Even though it's voluntary, the new HHS Guidance is significant to the extent it lays out the agency's expectations of the … [Read more...]

FLSA

Case of the Month: Hospital Employees’ Wage Class Action Lawsuit Goes Terribly Wrong

It wasn't the outcome the four hospital employees envisioned when they filed their lawsuit charging the University of Pittsburgh Medical Center of violating the federal Fair Labor Standards Act (FLSA) … [Read more...]

DIAGNOSTIC DEALS

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

A government shutdown, ongoing tensions with China and concerns about continued economic growth have marked the beginning of 2019. Against this backdrop, diagnostic deals continue to move forward. … [Read more...]

LEGISLATION

From DAIA to the VALID ACT: The Latest Chapter in FDA Diagnostic Test Oversight Reform

While FDA oversight over new diagnostic tests is perfectly acceptable, what is objectionable is the agency's continued reliance on a regulatory regime designed not for lab tests but medical devices. … [Read more...]

INDUSTRY BUZZ

FDA Watch: Agency Floats Plan to Simplify 510(k) Premarket Review

Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including diagnostics. Here's a quick … [Read more...]

WORKING WITH PAYERS

Billing & Coding: Pathology Group Asks CMS to Raise Medicare Prices for BRCA1/2 Sequencing Tests

The Association for Molecular Pathology (AMP) thinks the final 2019 Clinical Laboratory Fee Schedule payment amounts shortchanges labs that provide BRCA genetic testing and is calling on CMS to … [Read more...]

NEWS

Government Shutdown: The Impact on the Agencies that Regulate Labs

As we go to press, the longest U.S. government shutdown in history drags on with no end in sight. And while it may not affect your lab directly, the shutdown will have an indirect impact to the extent … [Read more...]

REIMBURSEMENT

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

Tennessee Pain Doctor Faces Jail for Opioid Abuses, Medicare Fraud Case: The doctor is facing 45 charges, including 22 counts of illegal distribution of a controlled substance for routinely … [Read more...]

PAMA

Medicare Reimbursement: CMS Provides Needed PAMA Relief—But Newly Covered Hospital Labs Must Report in 2019

The battle between CMS and the lab industry over Medicare Part B pricing for lab tests could be on the road to resolution notwithstanding the ACLA's recent court loss. But even as the legal battle … [Read more...]


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