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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Ketamine Marketing Risks for Mental Health Providers
Ketamine marketing is under increasing regulatory scrutiny, with providers facing risk over claims, off-label promotion, and patie…
Peptides: Legal and Regulatory Risks 503A Compounding Pharmacies Must Understand
FDA scrutiny of peptide compounding is intensifying, and 503A pharmacies are squarely in focus. If you compound, source, or dispen…
HLA Wins Full Reversal of PBM Credentialing Denial for an Independent Pharmacy
This week, Health Law Alliance achieved full reversal of a PBM credentialing denial for a New York pharmacy, mere weeks after it r…
Building a Regulatory Compliance Checklist for Ketamine Therapy Providers
Ketamine providers face growing regulatory scrutiny across prescribing, marketing, and care models. A focused compliance checklist…
CMS Skin Substitute Reimbursement Limitations Signal Continued Scrutiny of Wound Care Providers in 2026
CMS’s 2026 reimbursement overhaul for skin substitutes signals more than cost control. It marks a sharp rise in audits, enforcemen…
From Prior Authorization to Network Termination: The PBM Audit Trend Independent Pharmacies Must Watch
PBMs are increasingly targeting pharmacies over their role in the prior authorization process, using vague allegations to justify…
Why PBMs are Investigating Provider-Patient Relationships: And What it Means for Your Pharmacy
PBMs are ramping up audit pressure in 2026, now targeting provider-patient relationships to justify recoupments and even network t…
FDA and Novo’s Uncharted Waters to Exert Pressure on Hims & Hers and GLP-1 Compounders
Novo’s lawsuit against Hims & Hers, coupled with FDA’s referral to the DOJ, marks a direct escalation against 503A compounded sema…
The 2025 Healthcare Fraud Takedown Is a Warning Shot for Wound Care Providers
Wound care is now an enforcement priority. The 2025 fraud takedown targets skin substitute billing, graft utilization, and Medicar…