Information regarding coding, coverage, and payment is provided as a service to our readers. Every effort has been made to ensure accuracy. However, HMP and the author do not represent, guarantee, or warranty that coding, coverage, and payment information is error-free and/or that payment will be received.

Please note this information is accurate as of the time of publication, but health care reimbursement information is fluid, so please consult your local coverage policies for exact details that apply to your practice.

Earlier this year, the Centers for Medicare & Medicaid Services (CMS) issued a new local coverage determination (LCD) impacting wound care providers, originally planned for implementation on October 1, 2023.¹ As part of this update, one could note imposed limits on the number of skin substitute applications over a specified period. For instance, prior to the new proposed LCD, when criteria was met, clinicians could provide 10 applications over 12 weeks for diabetic foot ulcers.¹ However, if the new LCD had gone into effect, these products could only be used 4 times in a 12-week period.¹

What Has Wound Care Professionals Concerned

This proposed LCD was met with debate, including concerns about the appropriateness of the 4-application standard in light of the wide variation of places of service, wound types, sizes, patient comorbidities, and other impactful clinical factors.² One practice submitted data from 289 wounds to CMS that showed that only 19% healed after only 4 applications of cellular-and tissue-based products.² This same data showed that African-American patients were more deeply impacted than Caucasian patients, with only 11% healing after 4 applications, and 73% taking 7 applications or more to heal.² In addition, larger wounds took more applications of these products to heal than smaller wounds. This example illustrates the concern of clinical community about such changes.

What Wound Care Professionals Should Know

However, on September 29, 2023, CMS issued the following statement that now appears at the top of relevant webpages regarding this determination³:

“Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (L35041/A54117) will not become effective on 10/01/2023. A new Proposed LCD will be published for comment and presented at an Open Meeting in the near future. In the meantime, current coverage has not changed, and you are viewing the existing policy in effect."

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As a result, coverage, for now, remains unchanged. However, it reinforces the importance of understanding these policies and how they impact practice and patients. It is worth noting other updates that occurred in the past year, along with key pearls in the reimbursement process, with respect to cellular- and tissue-based products and reimbursement in wound care. It is crucial that providers and anyone involved in the reimbursement process familiarize themselves with their local Medicare Administrative Contractor (MAC) and the associated LCDs and local coverage articles (LCAs). This information can change, so regular consultation and reference to these documents is vital. Items of particular interest include lists of covered and non-covered CTPs. The previously released policy (now on hold) removed coverage for 130 CTPs, so continued consultation of one's local policy is advisable.⁴ Best practices for application and subsequent reimbursement for use of a covered-CTP includes documenting and meeting all of the requirements for coverage, selecting the correct size for minimal waste, and assuring the use of appropriate modifiers.⁵

Proper documentation remains a cornerstone of successful coding and reimbursement for any health care service. Recent and potential future policies are no exception. In general, the following components continue to be some of the necessary inclusions into the medical record to support coding for cellular- and tissue-based products⁶:

• Legibility
• Inclusion of appropriate patient identifiers
• Legible signature of the rendering provider
• The medical record must support the chosen diagnosis code(s)
• The medical record must accurately describe the chosen procedure code(s)
• Medical necessity for the chosen treatment must be established

Clinical information necessary to support medical necessity, along with diagnosis-specific items can be found in one’s LCD, and examples are included in a recent article by Cartwright.⁶ For the latest updates on CTP application policies from Medicare, check back to this Practice Accelerator during the month of December 2023 for more information if it arises. You may also find more reimbursement information at Today’s Wound Clinic on www.todayswoundclinic.com.

References

1. Centers for Medicare & Medicaid Services. Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. Medicare Coverage Database. Accessed October 31, 2023.
2. Carpenter S. Wound size matters: analysis of the new restrictive skin substitute LCD policy. Today’s Wound Clinic. Published September 2023. Accessed October 31, 2023. https://www.hmpgloballearningnetwork.com/site/twc/letter-editor/wound-s…
3. Centers for Medicare & Medicaid Services. Billing and Coding: Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds. Accessed October 31, 2023. https://www.cms.gov/medicare-coverage-database/view/article.aspx?articl…
4. Alliance of Wound Care Stakeholders. Following Tenacious Advocacy from the Wound Care Community, Medicare Administrative Contractors Withdraw Local Coverage Policy that Disrupted Care, Dramatically Restricted Access to CTPs (Skin Substitutes). Published September 28, 2023. Accessed October 31, 2023. https://www.woundcarestakeholders.org/images/Advocacy_Mobilizes_Withdra…
5. Schaum KD. As CTP Coverage Changes, Focus on What You Can and Should Do! Today’s Wound Clinic. Published August 2023. Accessed October 31, 2023.https://www.hmpgloballearningnetwork.com/site/twc/business-briefs/ctp-c…
6. Cartwright D. New LCD and LCA Documentation Requirements for Application of CTPs. Today’s Wound Clinic. Published August 2023. Accessed October 31, 2023. https://www.hmpgloballearningnetwork.com/site/twc/new-lcd-and-lca-docum…