FDA Resounds the Alarm on Biotin Test Interference

In early November 2019, the FDA undated a previous safety communication about the potential of biotin to significantly interfere with diagnostic tests. The update reiterates the warning to lab … [Read more...]

Genetic Testing: CMS Proposes Expanding NGS Testing Eligibility

In a reversal, CMS is now proposing to cover FDA-approved or -cleared germline NGS testing for breast and ovarian cancer patients who have risk factors that suggest they should receive testing to … [Read more...]

CLIA: CMS Revises State Operations Manual for Labs

In late September, the Centers for Medicare and Medicaid Services (CMS) released QSO-19-20-CLIA: Revisions to State Operations Manual (SOM), Chapter 6—Special Procedures for Laboratories. The release, … [Read more...]

CMS

Hospital Labs: CMS Pushes Forward with Controversial Price Transparency Rules

Brushing aside the intense objections and negative feedback, CMS pressed forward with price transparency by including as part of the 2020 Outpatient Prospective Payment System final rules the … [Read more...]

NEWS

The Year in Labs Regulation: The 6 Biggest Stories of 2019

"May you live in interesting times.” This ancient Chinese curse extolling the virtues of stability may resonate with those of you who work in the lab industry and have a stake in federal … [Read more...]

ANTI-KICKBACK

Alabama Doctors, Cardio Practice, Settle Genetic Testing Kickback Claims for $1.1 Million 

Case: Three doctors and a cardiology practice, all based in Alabama, have agreed to shell out $1.1 million for allegedly taking bribes from a now-bankrupt genetic testing company in the Seattle area. … [Read more...]

LABS IN COURT

Texas Scammer Gets 20 Years for Role in $50 Million Lab Test Ripoff

Case: The plot unfolded 10 years ago when a then 26-year-old woman and three co-conspirators set up 24 phony diagnostic testing centers in Houston. Offices were rented in 28 locations even though none … [Read more...]

LABS IN COURT

Feds Take Down Florida Substance Abuse Clinic Principles for Drug Test Fraud

Case: A trio of individuals associated with a Miami substance abuse facility were charged with taking part in a scheme to bill private insurers for tests that weren’t medically necessary or, in some … [Read more...]

LABS IN COURT

Urgent Care Centers Settle E/M Upcoding Charges for $2 Million

Case: The owners/operators of CareWell urgent care centers in Massachusetts and Rhode Island have agreed to shell out $2 million for improper coding of Evaluation and Management services. CPT code … [Read more...]

COMPLIANCE PLANS

OIG Work Plan: Agency to Focus on Collection of Medicare Advantage Ordering Provider Identifiers

OIG needs ordering provider identifiers in the Medicare Advantage (MA) encounter data to be available so it can use the data to identify and prevent potential fraud, waste and abuse. However, although … [Read more...]


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