Wound Care Providers and Businesses
At Frier Levitt, we understand the complex regulatory and transactional landscape that wound care providers and businesses face. Our team of experienced healthcare attorneys is dedicated to helping wound care professionals, including mobile wound care providers, navigate state and federal regulatory compliance, business transactions and payment audits by third-party payors.
The wound care sector continues to evolve rapidly in 2025, presenting both significant opportunities and complex legal challenges for providers. With an aging population, rising prevalence of chronic conditions like diabetes, and the growing demand for home-based care services, wound care has become an increasingly vital healthcare specialty. However, wound care providers face a uniquely complex regulatory environment that requires specialized legal guidance to navigate successfully.
Regulatory Compliance: Navigating the Changing Landscape
Wound care practices and providers must remain vigilant with respect to their compliance with federal fraud and abuse laws, particularly the Anti-Kickback Statute (AKS), the Stark Law, and the False Claims Act. These laws significantly impact common wound care arrangements, including:
- Referral Relationships: The complex nature of wound care often involves multiple specialists, creating potential Stark Law and AKS concerns when referrals are made between providers with financial relationships. Marketing activities in wound care also tend to be fraught with regulatory risk, particularly if they are commission or productivity based.
- Product and Equipment Relationships: Arrangements with wound care product manufacturers or equipment suppliers must be carefully structured to avoid implications of improper inducements.
- Mobile Wound Care Services: As mobile wound care expands, particular attention must be paid to arrangements between visiting providers and facilities or home health agencies.
The OIG has increasingly scrutinized wound care arrangements. In fact, Medicare Part B payments for skin substitutes are so ripe for fraud due to the high reimbursement for these products, that these claims have made their way to OIG’s work plan (i.e., OIG is dedicating specific resources to evaluate these billing practices). Similarly, the Centers for Medicare & Medicaid Services (CMS) and private payors have intensified their focus on wound care, emphasizing the importance of adherence to regulatory standards to prevent fraudulent activities. We have already begun to see, and predict even more widespread, federal investigations of wound care practices and businesses that have not been vigilant in ensuring that their business relationships meet federal Anti-Kickback laws and regulations. Providers are urged to consult with counsel to implement robust compliance programs that include regular training, documentation protocols, and periodic internal audits to identify and address potential compliance issues before they attract regulatory attention.
Learn more about federal fraud and abuse laws.
Wound care providers must navigate varying state requirements for licensure and scope of practice, particularly challenging for those operating across multiple states. Mobile wound care providers face additional complexity, as they must ensure compliance with:
- Each state’s specific requirements for mobile healthcare services
- Scope of practice limitations for nurse practitioners and physician assistants performing wound care
- Corporate practice of medicine considerations that impact ownership and the overall structure of wound care practices
- Supervision requirements that may differ by location and provider type
- Facility licensure considerations for wound care centers
Frier Levitt regularly assists providers to navigate these complex issues and develop and implement compliant business structures, policies, and solutions for their business models.
Business Structuring for Wound Care Practices
The structure of a wound care practice must comply with state corporate practice of medicine doctrines while facilitating operational efficiency. Frier Levitt assists clients to evaluate and solve for the following key considerations when developing or restructuring relevant arrangements:
- Professional Entity Requirements: Many states require wound care practices to be structured as professional corporations (PCs) or professional limited liability companies (PLLCs) owned by licensed clinicians, or otherwise operate as a licensed facility.
- Management Services Organizations (MSOs): For non-licensed individuals, including private equity funds, seeking to participate in the wound care sector, MSOs can provide a compliant structure to support clinical operations while maintaining appropriate separation from clinical decision-making.
- Multi-state Operations: Practices operating across state lines must consider varying state requirements regarding ownership, supervision, and scope of practice.
We assist clients in developing and implementing effective wound care models while navigating complex business structures. Our support includes establishing new models, structuring participation through operating agreements, employment agreements, and vendor contracts, as well as facilitating mergers, acquisitions, and joint ventures to ensure long-term success that aligns with client goals.
Reimbursement Challenges and Audit Defense
Payors are making adverse coverage determinations for certain wound-care-related services. Understanding how to navigate medical necessity requirements and proper coding practices is critical for providers seeking reimbursement for the services they provide.
Proper documentation and accurate coding remain essential for wound care providers. Medicare and other payers require detailed documentation of:
- Wound measurements and characteristics
- Medical necessity for each treatment modality
- Progress notes demonstrating improvement or medical justification for continued care
- Appropriate use of advanced wound care products and therapies
Common areas of scrutiny include inadequate documentation of medical necessity for debridement procedures, inappropriate use of modifier codes, and insufficient documentation to support the level of service billed.
Wound care practices are facing increasing audit activity from Medicare contractors, Medicaid, and commercial insurers. When facing an audit:
- Develop a strategic response with experienced healthcare counsel
- Respond promptly to all requests for information
- Conduct internal reviews before submitting documentation
- Identify potential issues and consider disclosure options when appropriate
- Preserve appeal rights by meeting all deadlines
Proactively implementing a compliance program focused on documentation and coding can significantly reduce audit risk and prepare practices to respond effectively when audits do occur.
Mobile Wound Care
The growth of mobile wound care services helps address access challenges, particularly for homebound patients and those in long-term care facilities. Key legal considerations include:
- Transportation and Storage of Supplies: Ensuring compliance with requirements for transporting, storing, and disposing of medical supplies and waste
- Documentation Systems: Implementing secure, HIPAA-compliant mobile documentation systems
- Staffing Models: Developing compliant supervision structures for non-physician providers
- Facility Agreements: Creating clear contractual relationships with nursing homes, assisted living facilities, and other locations served
Mobile wound care providers must also address scope of practice limitations, as different states have varying requirements for physician supervision and independent practice authority for nurse practitioners and physician assistants. Our firm has extensive experience with mobile wound care models, helping clients tackle challenges and implement effective solutions with confidence.
The integration of telehealth into wound care presents both opportunities and regulatory challenges:
- State Telehealth Laws: Requirements for licensure, informed consent, and modalities of care delivery vary by state
- Reimbursement Policies: While telehealth reimbursement has expanded, policies differ significantly among payers and continue to evolve
- Remote Monitoring Compliance: Home-based wound monitoring technologies must meet HIPAA requirements and be sufficient to not only adhere to the applicable standard of care, but also to relevant billing guidelines
Practices implementing telehealth should develop comprehensive policies addressing these issues and regularly review them as regulations change.
Wound care providers are well-positioned to benefit from the continued shift toward value-based care models. Potential opportunities include:
- Bundled Payment Programs: Participating in episode-based payment models for surgical wound care and diabetic ulcer management
- Accountable Care Organizations (ACOs): Joining or partnering with ACOs to provide specialized wound care services
- Direct Contracting: Developing relationships with self-insured employers to provide cost-effective wound care services
- Pay-for-Performance Initiatives: Participating in programs that reward providers for achieving improved healing rates and reduced hospitalizations
A well-structured wound-care service can save payors money and improve the quality of care by avoiding emergency room visits, decreasing mortality and morbidity, and reducing post-surgical recovery times and hospital readmissions. Leveraging these outcomes by entering into favorable value-based payment models requires a law firm experienced in structuring alternative payment models because successfully engaging in these models requires careful contract review, data analysis capabilities, and compliant structures for sharing any resulting savings. Frier Levitt has represented many providers and third party administrators in navigating these issues and developing legally compliant payment arrangements with self-insured employers and other payors.
Why Choose Frier Levitt?
The legal landscape for wound care providers is complex and is subject to increasing scrutiny, necessitating specialized legal guidance to navigate successfully. By proactively addressing regulatory compliance, reimbursement challenges, and business structuring considerations, wound care providers can focus on delivering high-quality patient care while protecting their practices from legal and financial risk.
Frier Levitt’s healthcare attorneys bring decades of experience working with wound care providers to address these challenges. By partnering with knowledgeable legal counsel, wound care practices can develop strategies to mitigate risk, enhance compliance, and position themselves for sustainable growth in this dynamic healthcare sector.
How Frier Levitt Can Help
Frier Levitt provides strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you.
