DOJ

Compliance Perspectives: Use New DOJ Criteria to Vet the Effectiveness of Your Lab Compliance Program

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

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...]

ENFORCEMENT

Compliance Perspectives: Feds Using Medicare Laws to Prosecute Non-Medicare Arrangements

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...]

SELF-DISCLOSURE

Compliance Perspectives: How the New OIG Fraud Risk Indicator System Heightens the Imperative of Self-Disclosure

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

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

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

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

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

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...]

HEALTH CARE REFORM

Compliance Perspectives: PAMA Pitfalls & Survival Strategies

PAMA's deep Medicare reimbursement cuts have had a devastating impact on the lab industry. Recent CMS changes in the 2019 Final Rule should provide a degree of pricing relief but not until 2021. In … [Read more...]


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