Insights & Analysis
Practical guidance on PBM audits, federal investigations, compounding defense, DEA enforcement, telehealth compliance, and the regulatory pressures facing pharmacies and providers nationwide.
Any Willing Provider Laws and PBM Network Exclusion
Any willing provider laws can force a PBM to reinstate an excluded pharmacy, but ERISA preemption limits how far the statute reaches.
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Change of Ownership and Medicare Enrollment Risk
A Medicare change of ownership can transfer the seller's overpayment liability to the buyer. What CHOW mechanics and CMS-855 timin…
Corresponding Responsibility: The Pharmacist's Duty
Under 21 CFR 1306.04, pharmacists share legal responsibility for every controlled substance prescription, including how they resol…
DEA Biennial Inventory Requirements: Getting It Right
DEA biennial inventory rules govern timing, exact counts by schedule, and retention. What a pharmacist-in-charge needs to get righ…
Allergenic Extract Compounding Rules for Pharmacists
FDA's prescription-set framework and USP 797 Section 21 set separate rules for allergenic extract compounding, and state boards of…
Adverse Event Reporting for Compounded Preparations
Compounded-drug adverse events trigger different FDA reporting duties for 503A pharmacies and 503B outsourcing facilities, plus re…
UPIC Audits of Wound Care Practices: What Triggers Them
UPICs select wound care practices through data analysis, not complaints. What the outliers look like, and the compliance check tha…
Skin Substitute FCA Enforcement: The Government's Theories
DOJ's $309M Apex Medical settlement maps three theories driving skin substitute enforcement: pricing spreads, medical necessity, a…
Wound Care Prepayment Review: Documentation That Releases Claims
CMS prepayment review holds wound care claims until the record proves medical necessity. The ADR deadline and what reviewers check…
Physician Office Wound Care Billing: Site-of-Service and Supply Audits
Physician office wound care billing faces two audit vectors: place-of-service mismatches and skin substitute supply-line errors.