Bass, Berry & Sims Launches Advanced Wound Care Task Force Amid Heightened Scrutiny

Bass, Berry & Sims has launched a dedicated, multidisciplinary task force aimed at assisting companies in the advanced wound care sector. The initiative comes as the industry faces increased regulatory scrutiny and government investigations following a period of rapid growth.

The task force will provide guidance to clients, including manufacturers of advanced wound care products and healthcare providers, on navigating complex areas such as reimbursement policies, regulatory compliance, government enforcement actions, and False Claims Act matters. The significant expansion of the market for skin substitutes and cellular and tissue-based products has drawn substantial attention from federal agencies.

Recent government actions, including the U.S. Department of Justice's National Health Care Fraud Takedown, have prominently featured the wound care industry. Notably, Medicare and Medicaid reimbursement for skin substitutes has seen dramatic increases, prompting intensified oversight and recoupment efforts. A DOJ announcement highlighted that wound care fraud cases represented a large portion of significant fraud charges filed.

Attorneys Denise M. Barnes and Kristin M. Bohl, co-chairs of the task force, stated that the industry is "squarely in the crosshairs of federal enforcement agencies." They emphasized the critical need for strong documentation, internal auditing, and compliance programs to address evolving regulations and enforcement priorities. The firm anticipates the task force will help clients effectively manage the complex and changing legal and regulatory landscape.