Memo to lab managers and compliance officers: It may be time to rethink your data breach response strategy. This directive is the result not of any substantive changes to the HIPAA rules but rather to … [Read more...]
CYBERSECURITY
Compliance Perspectives: Complying with HIPAA Isn’t Enough to Manage Data Breach Liability Risks
August 5, 2019
ENFORCEMENT
Compliance Perspectives: Feds Using Medicare Laws to Prosecute Non-Medicare Arrangements
July 28, 2019
Myth: Risk of federal prosecution for health fraud and abuse applies only when you deal with Medicare, TRICARE or other federal health programs. Truth: While that used to be true, the times they are … [Read more...]
DOJ
Compliance Perspectives: Use New DOJ Criteria to Vet the Effectiveness of Your Lab Compliance Program
June 28, 2019
One of the primary responsibilities of a lab manager is to ensure that the lab's compliance program is effective. There's a lot on the line. Having an effective compliance program can help prevent … [Read more...]
COMPLIANCE
New OIG Report Confirms that Labs Are Still on the Enforcement Radar
June 24, 2019
After a recent dip, OIG enforcement activity has seemingly rebounded, at least in terms of total recoveries. That's the basic punchline from the newly published OIG Semiannual Report to Congress … [Read more...]
SELF-DISCLOSURE
Compliance Perspectives: How the New OIG Fraud Risk Indicator System Heightens the Imperative of Self-Disclosure
April 23, 2019
As hard as you try to keep your lab 100% compliant with healthcare fraud and abuse laws, you may discover that an inadvertent violation has occurred. At that point, the compliance imperative switches … [Read more...]
COMPLIANCE
Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
April 15, 2019
By Danielle Sloane bio and Elaine Naughton bio Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests … [Read more...]
FALSE CLAIMS
Compliance Perspectives: How to Spot & Avoid Kickback Risks under New EKRA Law
April 1, 2019
A new law passed to deal with the opioid epidemic has significant ramifications for labs including but not limited to those involved in drug addiction and recovery programs. Specifically, the … [Read more...]
COMPLIANCE PERSPECTIVES
Compliance Perspectives: CMS Reviews PAMA Reporting Basics for Hospital Outreach Labs
February 25, 2019
PAMA reporting is tricky business in which mistakes and omissions carry the risk of civil monetary penalties of up to $10,000 per day. So, whether you're with a freestanding lab that's been through … [Read more...]
OSHA
Compliance Perspectives: A 10-Step Compliance Strategy for OSHA Recordkeeping Rules
February 5, 2019
January is the season when employers must compile their OSHA logs for the previous year. The good news is that many labs are exempt from these requirements. Here's an overview of the OSHA … [Read more...]
LEGISLATION
New Broad All-Payor Kickback Law Impacting Laboratories, Commission-based Compensation and more
January 14, 2019
By Danielle Sloane bio and Chris Climo bio In a recent piece of federal legislation intended to address the opioid crisis across the United States, Congress enacted a new all-payor kickback … [Read more...]
