Focus On

FDA Takes Unprecedented Measures to Promote Rapid Development of Coronavirus Diagnostic Tests

The FDA is following a two-prong strategy to promote and expedite development and validation of a test capable of safe, rapid and reliable detection of novel coronavirus (COVID-19), the disease caused … [Read more...]

NEW LAW

New Laws: Proposed Kickback Changes Would Provide Needed Relief But Also Largely Exclude Labs

In what could be the most significant story in health care fraud and abuse compliance of the past several years, the CMS and OIG proposed new rules (the Proposal) to adapt 20th century kickback laws … [Read more...]

PRECISION MEDICINE

Myriad Genetics Pays $9.1 Million to Settle Hereditary Cancer Test False Billing Claims

In March 2018, Myriad Genetics got a piece of mail no lab provider ever wants to see in its inbox: an OIG subpoena asking for billing records in connection with "an investigation into possible false … [Read more...]

FOCUS ON

ACLA Court Win May Tip the Battle Over PAMA Pricing

Take that, CMS! The American Clinical Laboratory Association (ACLA) can sue to get the agency's PAMA lab pricing scheme struck down after all. So ruled the US Court of Appeals for the District of … [Read more...]

FOCUS ON

Data Breaches Leave Labs and Patients Exposed

Two recent data breaches at major labs may have compromised the personal health information of approximately 19.6 million patients. No wonder the industry and privacy experts are revisiting best … [Read more...]

ENFORCEMENT

Focus On: State AGs Break New Ground by Teaming Up to Enforce HIPAA

Lab managers and compliance officers take note: For the first time ever, state attorneys general (AGs) have banded together to go after a health care provider for HIPAA violations. Although the … [Read more...]

FOCUS ON

State Law Round-up: New Privacy Breach Notification Laws Potentially Affecting Labs

As illustrated by the recent MIE settlement (click here for the story), security breaches involving patients' electronic protected health information (ePHI) exposes your lab to liability risks under … [Read more...]

FOCUS ON

Surviving PAMA: Keep an Eye on Industry Disruptors

A talking point of a G2 Lab Institute 2018 presentation deserves closer attention, especially given its implications for the lab industry. "Advantages and Disadvantages Confronting Labs in a … [Read more...]

FOCUS ON

New Project Aims to Provide Legal Guidance Needed to Do Business in Genomics

Technology changes faster than the laws designed to regulate it. Thus, while DNA testing has changed medicine and fueled growth in the lab industry, it has also created new legal challenges that few … [Read more...]

COMPLIANCE

DOJ Explains What It Wants from a Compliance Program

While it may not prevent all violations, the right compliance program can help your lab get lighter penalties if things go wrong. But what exactly is "the right compliance program." On April 30, the … [Read more...]


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