Anti-Kickback

Special Report: Long Awaited Kickback Relief Rules Keep Labs in the Cold

They’re finally here! After years of talking about adapting the decades-old kickback laws to modern medical market conditions, CMS and OIG proposed new rules (the Proposal) on Oct. 9, 2019. Whether it … [Read more...]

You Make the Call: Does Lab Manager Have a Valid Claim for Age Discrimination?

What’s At Stake As lab manager involved in personnel decisions, you have a responsibility to ensure your lab complies with the Age Discrimination in Employment Act (ADEA), which bans taking … [Read more...]

Compliance Perspectives: Avoid HIPAA Violations When Denying Patient Requests to Amend PHI

On Sept. 9, 2019, the HHS Office for Civil Rights (OCR), the agency that enforces HIPAA rules, announced that it had done something it has never done before: settle an enforcement action for not … [Read more...]

COMPLIANCE

Compliance Perspectives: What to Do When Respiratory Safety & Religious Rights Collide

THE SCENARIO A lab requires all employees who work with or near materials emitting toxic vapors to wear respirators with tight-fitting facepieces. Since facial hear interferes with a tight seal, … [Read more...]

CYBERSECURITY

Compliance Perspectives: Complying with HIPAA Isn’t Enough to Manage Data Breach Liability Risks

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...]

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...]

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...]

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...]


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