Q&A: Staying Ahead of LCD Updates for Skin Substitutes

Expert answer from Donna J. Cartwright, MPA, RHIA, CCS, RAC, FAHIMA:

While we still do not know whether the future effective local coverage determinations (LCD) for cellular and/or tissue-based products (CTPs) will take effect on January 1, 2026, there are many activities that providers should review, regardless of whether the LCD becomes effective or not. Currently, providers should be aware that, during the creation of the future effective LCD, Medicare contractors conducted an extensive literature review of all CTPs for diabetic and venous ulcers of the lower extremity. These literature reviews are already tools used by Medicare contractors to determine if a CTP is reasonable and necessary for the disease state. 

Providers must be aware that Medicare contractors cover services that meet the reasonable and necessary criteria for coverage. This coverage does not necessarily mean that if a product is FDA-approved, cleared, or registered as a tissue with the FDA, the contractor will be paid for it. Part of the review may include an examination of peer-reviewed, published clinical articles on the product. Please make a point of reviewing the literature summaries and citations in future effective LCDs to see what peer-reviewed evidence is available for a product. 

It is also suggested that providers conduct internal or friendly audits to ensure compliance with all documentation requirements surrounding the use of CTPs. All Medicare contractors have a detailed list of documentation from the LCDs that they are looking for during the audits. Additionally, the utilization criteria for considering these products for treatment are outlined in the LCDs. Some products may have limitations that restrict their use to specific indications, a limited number of applications, and other required application criteria, such as a 4-week treatment period before considering a CTP application. 

As many of you are already aware, there have been multiple Office of Inspector General (OIG) actions regarding CTP use, as well as articles published in the NY Times. It is essential to stay current and read these types of reports when they are released. They tend to give excellent insight into the issues of concern for CMS. 

Additionally, remember that the provider is responsible for all claims submitted under their Medicare ID, regardless of who performs the coding. If you have not done so recently, you may want to review the LCDs against your current documentation and billing practices to ensure compliance with the numerous requirements outlined in the coding and billing practices for CTPs. It is always a good idea to involve the entire team in reviewing charts so that everyone is on the same page. 

Lastly, stay tuned, as the final rules for payment in hospital outpatient departments, ambulatory surgery centers (ASCs), physician offices, and provider-based departments will be released toward the end of October.  Be sure to read these in detail once they are published.