Insights & Analysis
Practical guidance on PBM audits, federal investigations, compounding defense, DEA enforcement, telehealth compliance, and the regulatory pressures facing pharmacies and providers nationwide.
More articles — Page 39
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Insanitary Conditions Findings at Compounding Facilities
FDA uses the insanitary conditions theory under FDCA Section 501(a)(2)(A) to adulterate compounded drugs and drive recalls, withou…
Telehealth Records Requests From Payers
Payers are pulling telehealth platform session logs and timestamps beside the chart note, and a documentation gap can become an ex…
Deciding Whether to Plead in a Healthcare Fraud Case
What a healthcare fraud plea agreement can contain: counts of conviction, loss and restitution stipulations and appeal waivers, an…
FDA Escalation After a Warning Letter: Injunction, Seizure and Consent Decree
What follows an unresolved FDA warning letter: a voluntary recall request, seizure, a civil injunction, and the consent decree tha…
How Far Back a PBM Can Audit Your Claims
The PBM audit lookback comes from the network agreement, then state audit law, then the contract limitations period, never a fixed…
FDA Inspection of a Compounding Pharmacy: Scope, Records and Refusals
The Form 482 notice, 503A versus 503B records-access authority, sampling, photography, and what a refused inspection triggers.
DEA Registration and Change of Pharmacy Ownership
Why a DEA registration does not travel with a pharmacy sale, what the buyer must apply for, and how the closing has to be sequence…
Getting Your Records Back After a Federal Search Warrant
What happens to seized patient records, imaged servers, and privileged files after a federal search warrant, and how a Rule 41(g)…
Filing a Medicare Rebuttal Statement Before Recoupment Begins
What a Medicare rebuttal statement can and cannot do before recoupment begins, its filing window, and why it is not a substitute f…