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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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…
Common FDA Form 483 Observations at 503A Compounding Pharmacies
The categories of observation FDA investigators record on 503A Form 483s, from gowning and airflow to component records and beyond…
CID Oral Testimony: Preparing for a DOJ Examination
A civil investigative demand can compel sworn oral testimony, with set rules on who attends, transcript review, and the privilege…
DEA Inspections of Physician Practices: What Investigators Review
How DEA diversion investigators inspect physician practices, what they review, and when it becomes a legitimate medical purpose in…
DEA Form 224 Liability Questions: Answering Them Accurately
DEA Form 224's liability questions reach convictions, program exclusions, and license or registration history, and a false answer…
CMS and the UPIC: Which Contractor Actions Need CMS Approval
A UPIC requests records and makes review findings itself. Payment suspension and revocation need CMS approval first, per CMS's own…
Ampules, Single-Dose Vials and Multiple-Dose Containers Under USP 797
USP 797 assigns a different in-use time to ampules, single-dose vials and multiple-dose containers, a separate clock from a prepar…
AWP, WAC, NADAC and MAC: Pharmacy Pricing Benchmarks Compared
AWP, WAC, NADAC and MAC are set by different parties and measure different things. Here is what each means for a pharmacy's reimbu…
DAW 1 and DAW 2 Findings in a PBM Audit
A PBM audit can recoup a DAW-1 or DAW-2 brand claim when the file has no prescriber notation that the brand is medically necessary…