Insights & Analysis
Practical guidance on PBM audits, federal investigations, compounding defense, DEA enforcement, telehealth compliance, and the regulatory pressures facing pharmacies and providers nationwide.
Compromise and Settlement of a UPIC Overpayment
CMS can compromise a Medicare overpayment of $100,000 or less, but any indication of fraud removes that option and sends the claim to the Department of Justice.
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Expired Prescriptions and Refills Beyond Authorization in PBM Audits
A PBM audit tests prescription validity and refill counts; the federal controlled-substance limit and the state general limit are…
Practitioner Dispensing of Controlled Substances From the Office
Dispensing controlled substances from the office triggers DEA records, labeling, and state permit duties that prescribing alone do…
Pain Agreements and Urine Drug Screens: What DEA and Boards Expect
Treatment agreements, urine drug screens and PDMP checks build the record DEA and medical boards read to judge legitimate prescrib…
FDA Inspection Classifications for Compounders: NAI, VAI and OAI
What FDA's NAI, VAI and OAI inspection classifications mean for a compounding pharmacy, and what an OAI finding can trigger next.
DME Supplier Standards and Revocation for Noncompliance
DME suppliers can lose Medicare billing privileges for failed site visits, insurance lapses, or hours violations, not just claims…
DME Standard Written Order Requirements
A missing element on a DME order under 42 CFR 410.38 denies the claim outright and can extrapolate into a large recoupment demand.
Advice of Counsel as a Defense in Healthcare Fraud Prosecutions
Advice of counsel can blunt a healthcare fraud case, but asserting it waives privilege and fails without full disclosure and good-…
ERISA Preemption and State PBM Laws: What Pharmacies Can Enforce
Rutledge v. PCMA and PCMA v. Mulready mark where ERISA preempts state PBM audit and network laws, and where a pharmacy can still e…
Disputing a Managed Care Plan Recoupment Notice
A Medicaid MCO recoupment notice starts a dispute under the plan's contract. State review, like New Jersey's PICPA process, follow…