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 66
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Medicare Telehealth Audits After the Flexibilities Expired
Medicare telehealth flexibilities lapsed twice in five months before Congress extended them through 2027. What changed, what staye…
When a Medicaid Audit Becomes a Criminal Investigation
The concrete signals that a civil Medicaid audit has become a criminal referral, from a payment suspension to an MFCU interview re…
Medicare Overpayment Demand Letters: Reading Yours Correctly
How to read a Medicare overpayment demand letter correctly: the required contents, the extrapolation sample behind the number, and…
Veterinary Compounding Under the New FDA Guidance
GFI #256 narrows when compounded veterinary office stock is lawful, and state veterinary and pharmacy boards add a second layer of…
Writing an FDA Warning Letter Response That Works
A compounding pharmacy's FDA warning letter response has to show root cause analysis, a dated corrective action plan, and commitme…
Getting Off UPIC Prepayment Review
There is no published error-rate threshold that ends UPIC prepayment review. What actually determines exit, and how practices mana…
Central Fill and Audit Documentation Gaps
How DEA rules split prescription records between originating and central fill pharmacies, and where PBM audits find the gap betwee…
Challenging Extrapolation in a UPIC Audit
How CMS's extrapolation rules work, where UPIC sampling methodology breaks down, and the deadline that decides whether providers c…
Challenging Extrapolation in a PBM Audit
How PBM extrapolation turns a small audit sample into a recoupment demand covering claims that were not reviewed, and the statisti…