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 67
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School-Based Medicaid Services Under Audit
How school districts get audited on Medicaid-billed IEP services, and the documentation and provider-qualification gaps that drive…
Medicare Advantage RADV Audits: Risk Adjustment Exposure
How CMS validates Medicare Advantage HCC diagnoses through RADV chart review, where extrapolation stands after litigation, and whe…
Medicare Audit Defense for Small Practices
A proportionate response to a Medicare overpayment demand protects a small practice's cash flow and appeal rights inside the first…
USP 800 Hazardous Drug Compliance for Pharmacies
Containment requirements, the assessment of risk exception, and the inspection findings that follow a USP 800 compliance gap.
Preparing for a Medicaid Site Visit
How announced and unannounced Medicaid site visits work, what inspectors check, and how to prepare staff and records in advance.
USP 795 Nonsterile Compounding Standards
What USP 795 requires for nonsterile compounding: master formulation records, beyond-use dating, and where FDA and state board ins…
Medicaid Recoupment and Your Cash Flow
How Medicaid payment suspension under 42 CFR 455.23 and prospective recoupment withholds affect cash flow, and how to negotiate re…
The 5 Percent Distribution Rule for Pharmacies
How the 5 percent rule at 21 CFR 1307.11 lets pharmacies transfer controlled substances without a distributor registration, and wh…
Sterility Testing Failures and Your Response
A failed USP <797> sterility test triggers a root cause probe, a recall decision, and separate state board and FDA reporting dutie…