Observed impact of skin substitutes in lower extremity diabetic ulcers: lessons from the Medicare Database (2015-2018)

Introduction: A particularly concerning complication of diabetes is chronic diabetic foot ulcers (DFUs), which affects approximately three million patients annually in the US. Management of DFUs accounts for $0.6-$4.5 billion in Medicare spending, rising to $6-$18.7 billion when infection management is included.1

The objective of this investigation of Medicare claims data was to assess the outcomes in patients receiving advanced treatment (AT) with skin substitutes for lower extremity diabetic foot ulcers (LEDUs) versus no AT (NAT) during a treatment episode.

Methods: A Medicare Limited Dataset (10/01/2015-10/02/2018) was used to retrospectively analyze individuals receiving care for a LEDU treated with AT or NAT (propensity- matched Group 1). AT was defined as high-cost skin substitute products reported under CPT codes 15271-15278 and the applicable Healthcare Common Procedure Coding System (HCPCS) Q-code. The analysis included major and minor amputations, emergency department (ED) visits and hospital readmissions. In addition, AT following parameters for use (FPFU)* was compared with AT not FPFU (propensity-matched Group 2). A paired t-test was used for comparisons of the two groups. A Bonferroni correction was performed when multiple comparisons were calculated.*FPFU = initiating AT within 30-45 days from the first visit of the episode of care and applying AT within the range of every 7-14 days.

Results: There were 9,738,760 patients with a diagnosis of diabetes, of whom 909,813 had a LEDU. In propensity-matched Group 1 (12,676 episodes per cohort), AT patients had statistically fewer minor amputations (p=0.0367), major amputations (p< 0.0001), ED visits (p< 0.0001), and readmissions (p< 0.0001) compared with NAT patients. In propensity-matched Group 2 (1131 episodes per cohort), AT FPFU patients had fewer minor amputations (p=0.002) than those in the AT not FPFU group.

Discussion: AT for the management of LEDUs was associated with significant reductions in major and minor amputation, ED use, and hospital readmission compared with LEDUs managed with NAT.