FDA’s Overreach on Compounded Peptides: Legal Battles and How Clinics Can Push Back
Introduction: Peptide therapies like BPC-157, TB-500 (Thymosin Beta-4), CJC-1295, and other short proteins have exploded in popularity across med spas, […]
Regulatory Compliance
WOUND CARE UPDATE: CY 2026 Medicare Physician Fee Schedule Final Rule (CMS1832F)
Published November 5, 2025 • Effective January 1, 2026 This update explains the new Medicare rule in clear terms and
Advanced Wound Care Products, Big Medicare Dollars & The Kickback Trap
From audits resulting in significant overpayment demands to indictments for alleged violations of the Anti-Kickback Statute, wound care providers are
FDA’s “Held for Sale” Interpretation: Device Reuse in Physician Offices and FDCA Liability
Practicing and hospital-based physicians may be surprised to learn that the Federal Food, Drug, and Cosmetic Act (FDCA) can extend
False Claims Act Statistical Sampling & Extrapolation: Case Law and Guidance
Statistical sampling and extrapolation are methods used by the Office of Inspector General (OIG) and Medicare Administrative Contractors (MACs) to
How Local Coverage Determinations (LCDs) Should Be Handled as Evidence Under the Bondi Administration
The weight of Local Coverage Determinations (LCDs) in False Claims Act (FCA) litigation has been a recurring legal battleground, and
Wound Care Healthcare Fraud is On the Rise – What You Need to Know About Protecting Your Practice
As the U.S. Department of Justice continues to crack down on healthcare fraud, wound care providers must take heed. As
Building a Culture of Healthcare Compliance: Step-by-Step Guidance
Elevating Healthcare Standards through Comprehensive Compliance Training and Best Practices In the intricate world of healthcare, compliance is more than
Making Sense of the Anti-Kickback Statute (AKS)
Intent and Purpose of the AKS The Anti-Kickback Statute (AKS) is fundamentally designed to safeguard the healthcare system by preventing:
