{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,30]],"date-time":"2026-03-30T22:00:40Z","timestamp":1774908040911,"version":"3.50.1"},"reference-count":35,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2025,1,22]],"date-time":"2025-01-22T00:00:00Z","timestamp":1737504000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Advances in Wound Care"],"published-print":{"date-parts":[[2026,1,1]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>\n                      Lower-extremity diabetic ulcers (LEDUs) affect more than 500,000 U.S. Medicare beneficiaries each year. Dehydrated human amnionic and chorionic allografts (DHACAs) are clinically effective complements to standard of care (SoC;\n                      <jats:italic toggle=\"yes\">e.g.,<\/jats:italic>\n                      surgical debridement, offloading, infection, and moisture control) when treating LEDUs. However, Medicare and commercial payer coverage have restricted access to DHACAs. Our objective was to compare the effectiveness of DHACAs versus SoC among Medicare beneficiaries with LEDUs for reduction of adverse outcomes such as mortality, recurrency, and major amputation.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Approach:<\/jats:title>\n                    <jats:p>We analyzed a retrospective cohort of U.S. Medicare claims for LEDUs between 2018 and 2022. LEDU claims were collapsed into episodes of care (EOC). Frequency distribution of characteristics was compared using univariate and bivariate statistics. Zero-inflated binomial regression with 1:1 nearest-neighbor propensity score matching evaluated six main outcome measures: mortality; wound recurrence; major amputation; minor amputation; emergency department (ED) utilization; and readmission.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>There were 25,760 Medicare EOCs between 2018 and 2022 representing 12,880 matched samples in the DHACA and SoC cohorts. DHACAs were associated with a 20% reduction in 30-day mortality (95% confidence interval [CI]:10%, 29%), 28% reduction in risk of major amputation (95% CI: 19%, 36%), 9% reduction in ED utilization (95% CI: 3%,14%), and 8% reduction in 30-day readmission (95% CI: 2%, 13%). DHACAs were noninferior for minor amputation rates and wound recurrence compared to SoC cohort.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Beneficiaries with LEDUs benefit significantly from DHACAs on multiple outcomes, including a lower risk of mortality. Providers should examine the appropriateness of DHACAs for patients with LEDU as part of wound management. Medicare and commercial payers should consider improved outcomes when defining coverage policies that restrict access to DHACAs given the observed benefits.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/wound.2024.0141","type":"journal-article","created":{"date-parts":[[2025,1,22]],"date-time":"2025-01-22T10:00:54Z","timestamp":1737540054000},"page":"41-49","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Comparative Effectiveness of Amniotic and Chorionic Grafts in the Treatment of Lower-Extremity Diabetic Ulcers Using U.S. Medicare Real-World Evidence (2018\u20132022): A Retrospective Observational Cohort"],"prefix":"10.1177","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1161-6954","authenticated-orcid":false,"given":"William V.","family":"Padula","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical &amp; Health Economics, Alfred E. Mann School of Pharmacy &amp; Pharmaceutical Sciences, University of Southern California, Los Angeles, California, USA."},{"name":"The Leonard D. Schaeffer Center for Health Policy &amp; Economics, University of Southern California, Los Angeles, California, USA."},{"name":"Stage Analytics, Suwanee, Georgia, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8620-6584","authenticated-orcid":false,"given":"Swetha","family":"Ramanathan","sequence":"additional","affiliation":[{"name":"Stage Analytics, Suwanee, Georgia, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benjamin G.","family":"Cohen","sequence":"additional","affiliation":[{"name":"Stage Analytics, Suwanee, Georgia, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francine","family":"Chingcuanco","sequence":"additional","affiliation":[{"name":"Stage Analytics, Suwanee, Georgia, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Steel","sequence":"additional","affiliation":[{"name":"Stage Analytics, Suwanee, Georgia, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kurt R.","family":"Herzer","sequence":"additional","affiliation":[{"name":"Rubrum Advising, Fort Washington, Pennsylvania, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,1,22]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1080\/13696998.2023.2232256"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2017.07.007"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12902-018-0327-2"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13047-020-00383-2"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.12404"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamasurg.2020.3845"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.10578"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.12968\/jowc.2022.31.Sup9.S16"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.48152"},{"issue":"7","key":"e_1_3_3_11_2","first-page":"1","article-title":"Skin Substitutes for Adults With Diabetic Foot Ulcers and Venous Leg Ulcers: A Health Technology Assessment","volume":"21","author":"Ontario Health (Quality)","year":"2021","unstructured":"Ontario Health (Quality). Skin Substitutes for Adults With Diabetic Foot Ulcers and Venous Leg Ulcers: A Health Technology Assessment. Ont Health Technol Assess Ser, 2021; 21(7):1\u2013165.","journal-title":"Ont Health Technol Assess Ser"},{"key":"e_1_3_3_12_2","unstructured":"US Congress. The Public Health Services Act 42 U.S.C. \u00a7\u00a7 361. 1952. Available from: https:\/\/www.loc.gov\/item\/uscode1952-004042006a\/"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.4103\/0970-0358.70712"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1089\/wound.2021.0123"},{"key":"e_1_3_3_15_2","unstructured":"Code of Federal Regullations \u00a7 1270-1271. Available from: https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/cfrsearch.cfm [Last accessed: December6 2024]."},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0204060"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1089\/wound.2018.0931"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.actbio.2019.06.002"},{"key":"e_1_3_3_19_2","unstructured":"Boulton AJ Armstrong DG Kirsner RS et al. Diagnosis and Management of Diabetic Foot Complications. Available from: https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK538977\/ [Last accessed: June7 2024]."},{"key":"e_1_3_3_20_2","unstructured":"Mohammed YA Farouk HK Gbreel MI et al. Human amniotic membrane products for patients with diabetic foot ulcers. do they help? A systematic review and meta-analysis. Available from: https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC9472416\/ [Last accessed: June7 2024]."},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.12968\/jowc.2021.30.Sup7.S5"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1089\/wound.2023.0143"},{"key":"e_1_3_3_23_2","unstructured":"Centers for Medicare and Medicaid Services. Proposed LCD DL35041. Skin Substitute Grafts\/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. Available from: https:\/\/www.cms.gov\/medicare-coverage-database\/view\/lcd.aspx?LCDId=35041 [Last accessed: November14 2024]."},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1089\/wound.2023.0150"},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.1111\/wrr.12645"},{"key":"e_1_3_3_26_2","unstructured":"Snyder D Sullivan N Margolis D et al. Skin Substitutes for Treating Chronic Wounds. 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