Healing Outcomes and Cost Efficiency of Advanced Skin Substitutes for Diabetic Foot Ulcers Under the CMS Payment Framework

Abstract

Background: Diabetic Foot Ulcers (DFUs) are associated with substantial morbidity, health care utilization, and risk of lower-extremity amputation. Advanced wound treatments such as skin substitutes are commonly used in the management of DFUs when standard wound care alone is insufficient. Recent changes in the Medicare Physician Fee Schedule (PFS) and the Outpatient Prospective Payment System (OPPS) have standardized reimbursement for skin substitutes based on surface area applied, increasing interest in healing outcomes and treatment-related costs under the CMS payment framework.

Objective: To descriptively compare published healing outcomes and estimated cost per healed DFU across selected advanced skin substitutes in the context of CMS payment policies.

Methods: A descriptive comparison was conducted using published DFU healing probabilities and estimated treatment-related costs for five advanced skin substitutes: Helicoll®, Grafix®, Apligraf®, Dermagraft®, and EpiFix®. Cost per healed DFU was calculated as the ratio of estimated treatment-related cost to reported healing probability. The primary effectiveness outcome was complete ulcer healing at 12 weeks. Cost assumptions were standardized using publicly available CMS reimbursement methodologies. No probabilistic modeling or ICER-based cost-utility modeling was conducted.

Results: Among the reported healing probabilities ranging from approximately 0.30 to 0.83 across products, Helicoll demonstrated a favorable balance of cost and effectiveness, with an annual per-patient cost of $20,000 and a reported wound closure rate of 0.83 in a 4-week clinical study with 1-week follow-up. This resulted in an estimated cost per healed DFU of approx. $24,000, which was substantially lower than comparator products. Estimated treatment-related costs varied substantially, resulting in wide variation in calculated cost per healed DFU. Helicoll has the higher reported healing probabilities and the lowest calculated cost per healed DFU among evaluated products.

Conclusion: In this comparative effectiveness analysis, Helicoll provided clinically meaningful healing outcomes at substantially lower cost compared with other specific advanced skin substitutes. These findings support Helicoll as a cost-effective treatment option for DFU management from a payer perspective and may inform reimbursement and formulary decision-making. This analysis provides a transparent cost-per-responder framework but does not constitute a formal cost-effectiveness model or systematic comparative effectiveness evaluation. Head-to-head trials and probabilistic economic modeling are required for definitive payer decision-making.