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 70
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Specialty Drug Audit Defense for Pharmacies
Why specialty pharmacies face heavier PBM audit scrutiny, and the network, accreditation, and REMS documentation that defends agai…
Recalling a Compounded Drug: Process and Exposure
How compounded drug recalls are classified and reported, and the licensure and liability exposure a pharmacy faces once one starts…
DME Medicare Audits: Proof of Delivery and Orders
How RAC and UPIC auditors reconstruct the DME documentation chain, from the standard written order to the proof of delivery on fil…
Medicaid Pharmacy Audits: State Program Integrity
How state Medicaid program integrity units audit pharmacy dispensing records, and how that process differs from a commercial PBM a…
Telemedicine Controlled Substance Prescribing Rules
The Ryan Haight in-person exam rule, the DEA's fourth extension through 2026, and what pharmacists must verify before dispensing.
Medicaid Enrollment Denials and Provider Screening
How the federal risk-level screening framework and ownership disclosure rules under 42 CFR Part 455 drive Medicaid enrollment deni…
Registering as a 503B Outsourcing Facility
The FDA registration mechanics, annual re-registration window, fees, and cGMP obligations a pharmacy takes on by converting to 503…
Suspicious Order Reporting: Beyond Monitoring
What 21 CFR 1301.74(b) requires beyond a monitoring system, the current DEA reporting channel, and how to document due diligence o…
Diagnostic Imaging Medicare Audits
Ordering physicians face signed-order documentation demands, a paused AUC penalty phase, and Stark Law self-referral exposure in i…