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
October 17, 2019
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
August 26, 2019
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
August 5, 2019
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
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...]
