Building a Better Skin Substitute Strategy: The Role of Specialty EHRs

By:  Amanda Linderman
Vice President of Sales, Net Health Wound Care

In my 20 years in the wound care industry, I’ve seen some truly remarkable innovations. Quantum leaps in technology have helped to revolutionize our industry, leading to some truly awe-inspiring advancements in areas like skin substitutes. The most meaningful thing to me is the fact that we live in an era where we can help people with painful and debilitating conditions like burns, chronic pressure ulcers, and surgical infections gain back functionality, reduce pain and discomfort, and, in many instances, return to the lives they once had.  

While opening new therapeutic doors, these advancements also raise a number of questions for providers and payers. Which therapies are the best for which patients? What does clinical research show us? Which products are safe, and which are risky? How do we balance the cost-benefit equation? How do we decide which patients get which promising products and when?

These are essential discussions that need to occur across our profession and beyond, and I encourage our industry to explore them fully. However, there are patients that need our help today, and we must better understand and manage routine practice issues and policies to provide the care they need. Let’s look at some of the problems related to the use of skin substitutes wound care providers face and how we can use technology, best practices, and dialogue to help address issues and establish a path forward.

Defining the Category

Skin substitutes are one of those medical miracles thought impossible in previous eras. Clinicians describe them as an “advanced therapy recommended for wounds that fail to [decrease] in size with standard care.” The therapeutic category is defined as medical products replacing missing skin or providing a temporary or permanent covering for damaged skin.

Skin substitutes promote tissue regeneration, reduce the risk of infections, and minimize scarring, all of which helps wound healing. These substitutes can range from biological materials like human or animal-derived tissues (I’ve heard amazing things are happening with fish skin) to synthetic products such as films, foams, or hydrogels. Even more remarkable advancements like nanotechnology and stem cell therapy are.

Skin substitutes fall into classes based on their type. They can belong to Class I, II, or III, depending on their composition and usage. Regulatory bodies determine three classes of medical devices based on their potential risk and intended usage. The highest-risk devices, like implantable ones, fall into Class III. On the other end of the spectrum, low-risk devices are considered Class I. Class III devices are those that could support or sustain life, prevent health problems, or pose significant risks. They require special regulatory approval. Knowing a skin substitute classification is essential for providers in terms of not only clinical utilization but also to ensure safety and regulatory and reimbursement compliance.

Operational and Regulatory Challenges

With all these remarkable advances and regulatory guidelines, one of the first questions facing providers is, what product should I select for a specific patient? Providers should base the choice of substitute on clinically supported evidence, but this can vary depending on the patient’s etiology, age, and overall health status. To further complicate the therapeutic decision-making process, more than 75 skin substitutes are currently available, and that number is rising. According to CMS, 19 new  skin sub-HCPCS codes exist as of the beginning of 2024.

Think that’s enough to make product selection daunting? There’s more. CMS and the Office of Inspector General (OIG) carefully scrutinize the use of skin subs to avoid fraud and abuse, and there are multiple regulatory and plan-specific requirements to consider. A bioengineered skin sub you can order in a hospital setting may not be allowed in a nursing facility. Even the size of the wound impacts reimbursement and setting. In Today’s Wound Care Clinic, Shaun Carpenter, MD, CWSP, WMS, writes, “Wound Care Clinics can treat wounds with skin substitutes of much larger sizes because of its Q-code (per square centimeter) reimbursement structure.”

Determining when, how, and what to use in terms of skin substitutes is a multifaceted process that requires considerable research, experience, and clinical expertise.

How Your EHR and Digital Wound Care Platform Can Help

If you’re ready to throw up your hands, don’t despair yet! While there are multiple issues to understand, there are things you can do today to make sure you take advantage of innovative products and ensure you are within regulatory guidelines. It starts with your electronic health record systems (EHRs) and digital wound care platforms. These tools can streamline processes, enhance decision-making capabilities, and improve patient outcomes.

Specialty EHRs offer several advantages in the management of skin substitutes. They provide:

• A centralized platform for accessing and documenting patient data.
• Technology to ensure wound care providers have real-time access to pertinent information regarding wound status.
• Summaries of previous treatments and outcomes.
• Insights into patient-specific considerations.

Data like this facilitates informed decision-making tailored to the patient’s needs and medical history. EHRs can also help manage the skin substitute process by:

• Ensuring accuracy and completeness for payer billing — coding. Top specialty EHRs integrate and continuously update with ICD-10 (International Classification of Diseases, 10th Revision) and CPT (Current Procedural Terminology) codes. When a provider documents the use of a skin substitute in the EHR, the system can automatically suggest relevant diagnosis and procedure codes based on the documentation, reducing the likelihood of coding errors and ensuring accurate billing.

• Ensuring accuracy and completeness for payer billing — documentation. Documenting the care process is crucial to avoid audits and ensure timely reimbursement. EHRs should include documentation templates with the fields necessary for documentation, including type of wound, size, depth, location, product used, etc. Providers can ensure comprehensive documentation of the patient’s condition and treatment by providing templates and forms that include skin substitutes.

• Supporting continuity of care. EHRs facilitate seamless communication and collaboration among today’s multidisciplinary healthcare teams involved in wound management. Through features like secure messaging functionalities and shared access to patient records, wound care providers can coordinate treatment plans, monitor progress, and promptly address any concerns or changes in the patient’s condition. This interdisciplinary clinical pathway fosters a holistic approach to wound care, enhancing the efficiency and effectiveness of skin substitute utilization.

• Managing clinical oversight. When combined with AI-powered digital wound care platforms, EHRs help to enhance the selection, application, and monitoring of skin substitutes through various features. For instance, digital imaging systems enable accurate assessment and measurement of wounds, allowing healthcare providers to precisely evaluate wound characteristics, such as size, depth, and tissue composition. Data like this empowers clinicians to make evidence-based decisions regarding the type and placement of skin substitutes and healing rates, thereby optimizing wound healing outcomes.

• Facilitating remote wound assessment and virtual consultations. The growth of telemedicine impacts all healthcare areas–including skin substitutes. Providers at rural facilities that may not have a full wound care team can still send information to and from wound care specialists to receive timely guidance and support without needing patients to travel. These telehealth solutions enhance accessibility to wound care services and promote proactive monitoring of wound healing progress, ensuring timely intervention when necessary.

Expect Future Innovations

New advancements are further expanding the use and benefits of skin substitutes. Integrating AI algorithms and predictive analytics into wound care systems holds promise for enhancing treatment algorithms and optimizing patient outcomes. By analyzing vast amounts of clinical data and patient-specific variables, AI-powered platforms can assist wound care providers in predicting wound healing trajectories and identifying risk factors for complications. This data-driven approach empowers clinicians to deliver tailored interventions that address each patient’s unique needs and characteristics, ultimately improving the efficiency and effectiveness of wound care management.

The world of skin substitutes remains promising. The best way to optimize its potential is to encourage dialogue among all stakeholders (from clinicians to payers to the regulatory staff at CMS), conduct and report on meaningful research and adopt and expand advanced wound care technology.

I see daily how innovative wound technology has transformed the landscape of wound care management, particularly in selecting, ordering, and managing skin substitutes. By leveraging breakthrough tools like digital imaging and AI-powered apps, wound care providers can streamline processes, enhance decision-making capabilities, and optimize patient outcomes. Most importantly, the seamless integration of digital health solutions allows healthcare organizations to achieve greater efficiency, effectiveness, and accessibility in wound care delivery, ultimately improving the quality of life for patients with chronic wounds.