Insights & Analysis
Practical guidance on PBM audits, federal investigations, compounding defense, DEA enforcement, telehealth compliance, and the regulatory pressures facing pharmacies and providers nationwide.
Medicaid Audit Preparation Checklist for Provider Offices
A practical checklist for logging the notice, preserving records, reading the provider manual, and bringing in counsel before signing any certification.
All articles
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EKRA Explained: Kickback Rules for Labs and Treatment Centers
EKRA reaches commercial insurance, not just federal programs, and its exceptions differ sharply from the Anti-Kickback Statute's f…
REMS Requirements for Pharmacies: Certification, Checks and Audits
A Risk Evaluation and Mitigation Strategy can require pharmacy certification, an authorized representative, staff training, and a…
Florida Permits for Compounding Pharmacies and Outsourcing Facilities
Florida requires its own permits, separate from FDA registration, for sterile compounding pharmacies, outsourcing facilities, and…
DAW Codes 0 Through 9: What Each Code Tells the PBM
How DAW codes 0 through 9 tell a PBM who chose a brand over a generic, and what the hard copy has to show to back up the code.
Health Law Alliance Protects Independent Pharmacy from Network Termination After PBM Audit
Health Law Alliance defended a community pharmacy facing potential OptumRx network termination after an audit. The pharmacy kept i…
How a Minor PBM Audit Finding Can Put Your Pharmacy’s Network Status at Risk
A single PBM audit finding, such as a missing invoice or an incomplete signature log, can become the basis for a network terminati…
When PBM Audit Findings Escalate: CMS Referrals, UPIC Audits, and Broader Pharmacy Risk
Adverse PBM audit findings can lead to CMS referrals, UPIC audits and Board of Pharmacy scrutiny. Why the first response and the a…
Appealing a Medicare Revocation: Reconsideration and DAB Review
A Medicare revocation appeal runs through reconsideration, an ALJ hearing at the DAB, and further review, with billing stopped thr…
DME Fraud Charges: How Supplier Cases Are Built
Nominee ownership, enrollment misstatements, and billing after a refusal can turn a DME supplier audit into a criminal referral to…