Health & Wellness

340b drug pricing program compliance for hospital pharmacy directors, cfos, and compliance officers. covers covered-entity eligibility requirements under 42 usc §256b, the gpo prohibition for inpatient drugs, patient definition, contract pharmacy oversight, duplicate discount prohibition, orphan drug exclusion, and hrsa audit exposure. institutional-level 340b program integrity posture, not individual-transaction guidance only.

institutional anti-kickback statute compliance analysis for hospital compliance directors, cfos, and in-house counsel. maps compensation and referral arrangements to aks one-purpose test under 42 usc §1320a-7b(b), applies safe harbor regulations under 42 cfr §1001.952, analyzes oig advisory opinion precedent, and quantifies criminal and civil exposure including false claims act overlay. system-level institutional arrangement audit, not individual physician guidance only.

corporate practice of medicine doctrine analysis for health system counsel, private equity acquirers, and mso operators structuring physician employment and management relationships. covers state-by-state cpom prohibition analysis, friendly professional corporation (pc) / management services organization (mso) structure permissibility, employment vs. independent contractor distinctions, and enforcement risk from state medical boards and ag offices. institutional-level transaction and structure audit.

institutional emtala compliance for hospital cmos, cnos, and compliance officers navigating the medical screening exam duty, stabilization obligation, and transfer prohibition under 42 usc §1395dd. covers dedicated emergency department triggers, on-call physician obligations, appropriate-transfer certification elements, and cms enforcement exposure including per-day civil money penalties and medicare termination. system-level, not individual-encounter only.