Insights & Analysis
Practical guidance on PBM audits, federal investigations, compounding defense, DEA enforcement, telehealth compliance, and the regulatory pressures facing pharmacies and providers nationwide.
OIG Self-Disclosure Protocol: What a Submission Requires
What a complete OIG Self-Disclosure Protocol submission must contain, how damages are calculated, and what resolution brings once OIG accepts it.
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Pharmacy Permit Suspension and Revocation
State pharmacy boards can suspend or revoke a store's permit over grounds, notice and hearing rights, and the path back to dispens…
Patient Records When a Telehealth Platform Shuts Down
When a telehealth platform closes, sells, or freezes accounts, HIPAA retention and access duties stay with the treating clinician,…
License Probation Terms and Early Termination
A probationary license carries practice restrictions, chart review requirements, reporting duties, and a path to petition for earl…
FCA Liability for Billing Companies and Management Entities
The False Claims Act reaches billing companies that cause a false claim, and an indemnification clause does not decide who the gov…
Breaching a Corporate Integrity Agreement: Stipulated Penalties and Exclusion
Once a problem surfaces under an existing CIA, escalation runs one way: Reportable Event, Stipulated Penalties, Notice of Breach,…
Joint Defense Agreements in Healthcare Investigations
A joint defense agreement extends privilege across separately represented targets, but only for a genuine legal interest, and only…
Continuing Skin Substitute Applications When a Wound Is Not Healing
When a skin substitute graft does not close a wound on schedule, the record must show why continuing, changing, or stopping the co…
Commercial Payer Audits of Skin Substitute Claims
Commercial plans audit skin substitutes under their own medical policy and provider agreement, not Medicare's LCD, with network te…
Board Disciplinary Hearings: Procedure, Evidence, and Witnesses
Board disciplinary hearings test the burden of proof, the investigative file, and the standard-of-care witness, and procedure diff…