Insights & Analysis
Practical guidance on PBM audits, federal investigations, compounding defense, DEA enforcement, telehealth compliance, and the regulatory pressures facing pharmacies and providers nationwide.
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Selling Compounded Drugs to Other Pharmacies Under 503A
A 503A pharmacy may distribute compounded drugs only against a valid, patient-specific prescription, not as stock to another pharm…
Responding to an FDA Untitled Letter Sent to a Compounder
An FDA untitled letter cites violations below the threshold for a warning letter, but a compounding pharmacy's response still dete…
State Opioid Prescribing Limits and Day-Supply Laws
How acute-pain opioid day-supply caps, exceptions, and counseling rules differ across five states, and what it means for prescribe…
Potency Testing Failures and Out-of-Specification Results for Compounders
What a compounding pharmacy must do when a finished preparation's potency or assay result falls outside its own specification: qua…
Amount in Controversy for Medicare ALJ Hearings and Federal Court
CMS raised the 2026 Medicare amount in controversy to $200 for an ALJ hearing and $1,960 for federal court review of a denial or o…
Filter Teams and Privileged Material in a Healthcare Search Warrant
A DOJ filter team screens privileged material seized in a healthcare search warrant before investigators see it, but circuits spli…
Prescribing Controlled Substances to Family Members and Yourself
Federal and state rules on self-prescribing and treating family members with controlled substances, and how violations surface in…
Personal Exposure for Owners and Ordering Physicians in a UPIC Audit
A UPIC overpayment finding against the billing entity can still reach the practice owner, a buyer, or the ordering physician's own…
RPM Interactive Communication in Facility Settings: What Counts
What qualifies as the interactive communication CPT 99457 and 99458 require in a nursing facility, who may provide it, and what do…