Real-world outcomes of cellular, acellular, and matrix-like products (CAMPs) in Stage 3 pressure injury ulcers: A matched Medicare claims analysis (2016–2024)

Authors

DOI:

https://doi.org/10.63676/dj8g4218

Keywords:

Medicare, Pressure ulcer, comorbidity, Delivery of health care

Abstract

Background: Stage 3 pressure injuries (PIs) are full-thickness wounds associated with high morbidity, frequent infection-related complications, and substantial healthcare utilization in adults with compromised mobility. Real-world outcomes of cellular, acellular, and matrix-like products (CAMPs) for Stage 3 PIs in Medicare populations have not been well characterized.

Methods: We conducted a retrospective, matched-cohort study using Medicare claims data (2016–2024). Stage 3 PI ulcer treatment episodes were constructed using a 90-day clean period (defined as ≥90 days without wound-related services) and a 90-day episode definition and evaluated in a hospital outpatient department (HOPD)/inpatient-only sample. Episodes receiving CAMPs (identified by Q- and A- Healthcare Common Procedure Coding System (HCPCS) codes) were matched 1:1 to standard-of-care (SOC) episodes (which included sharp debridement without CAMPs) using a prespecified set of exact and range-based covariates including demographics, comorbidity burden, PI location markers, and timing measures. Outcomes included episode characteristics, complications (including sepsis), healthcare utilization, costs, and mortality (death within 90 days of episode end). Two minimum-duration cohorts were analyzed (90 and 120 days).

Results: For the 90-day minimum cohort (n=7223 matched episodes per group), CAMP episodes had lower mean PI-associated spending ($36,397 vs $39,886; p=0.0003) and lower mean total all-cause spending ($46,905 vs $50,686; p=0.0006). Compared with SOC, CAMP episodes were associated with lower complications and healthcare resources utilization, including lower sepsis (26.1% vs 36.1%; p<0.0001), lower major amputation (2.2% vs 3.1%; p=0.0004), fewer emergency department (ED) visits (1.34 vs 2.04; p<0.0001) and inpatient visits (1.52 vs 2.24; p<0.0001), and lower mortality (17.8% vs 22.3%; p<0.0001). Episode length was longer with CAMPs (323.8 vs 302.1 days; p<0.0001).

Findings were consistent in the 120-day minimum cohort (n=6139 per group), including lower mean total all-cause spending ($51,585 vs $56,865; p<0.0001), lower sepsis (28.8% vs 39.9%; p<0.0001), lower major amputation (2.4% vs 3.3%; p=0.0041), fewer ED visits (1.50 vs 2.29; p<0.0001) and inpatient visits (1.70 vs 2.49; p<0.0001), and lower mortality (18.4% vs 22.8%; p<0.0001). Episode length remained longer with CAMPs (359.6 vs 339.1 days; p<0.0001).

Conclusions: In matched Medicare Stage 3 PI episodes managed in the HOPD setting, CAMP use was associated with lower rates of sepsis, acute-care utilization, major amputations, mortality, total and PI ulcer–associated spending despite longer episode duration. These results further support confirmatory work incorporating greater clinical granularity and direct healing endpoints.

References

Zaidi SRH, Sharma S. Pressure ulcer. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing. 2025. https://www.ncbi.nlm.nih.gov/books/NBK553107/ (accessed 10 March 2026)

Russo CA, Steiner C, Spector W. Hospitalizations related to pressure ulcers among adults 18 years and older, 2006. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US). 2008. https://www.ncbi.nlm.nih.gov/books/NBK54557/ (accessed 10 March 2026)

Pang Y, Du Y, Zhou W, Liu S, Yuan Y. Trend analysis of pressure ulcers in adults 60 years and older from 1990 to 2021 using jointpoint regression and Bayesian age period cohort models. Sci Rep. 2025;15(1):25198. https://doi.org/10.1038/s41598-025-11027-5 DOI: https://doi.org/10.1038/s41598-025-11027-5

McAuliffe PB, Winter EE, Talwar AA, Desai AA, Broach RB, Fischer JP. Pressure Ulcer Trends in the United States: A Cross-Sectional Assessment from 2008-2019. Am Surg. 2023;89(12):5609-5618. https://doi.org/10.1177/00031348231158691 DOI: https://doi.org/10.1177/00031348231158691

Padula WV, Delarmente BA. The national cost of hospital-acquired pressure injuries in the United States. Int Wound J. 2019;16(3):634-640. https://doi.org/10.1111/iwj.13071 DOI: https://doi.org/10.1111/iwj.13071

Padula WV, Makic MB, Wald HL, et al. Hospital-Acquired Pressure Ulcers at Academic Medical Centers in the United States, 2008-2012: Tracking Changes Since the CMS Nonpayment Policy. Jt Comm J Qual Patient Saf. 2015;41(6):257-263. https://doi.org/10.1016/s1553-7250(15)41035-9 DOI: https://doi.org/10.1016/S1553-7250(15)41035-9

Padula WV, Black JM, Davidson PM, Kang SY, Pronovost PJ. Adverse Effects of the Medicare PSI-90 Hospital Penalty System on Revenue-Neutral Hospital-Acquired Conditions. J Patient Saf. 2020;16(2):e97-e102. https://doi.org/10.1097/PTS.0000000000000517 DOI: https://doi.org/10.1097/PTS.0000000000000517

Armstrong DG, Tettelbach WH, Chang TJ, et al. Observed impact of skin substitutes in lower extremity diabetic ulcers: lessons from the Medicare Database (2015-2018). J Wound Care. 2021;30(Sup7):S5-S16. https://doi.org/10.12968/jowc.2021.30.Sup7.S5 DOI: https://doi.org/10.12968/jowc.2021.30.Sup7.S5

Tettelbach WH, Driver V, Oropallo A, et al. Treatment patterns and outcomes of Medicare enrolees who developed venous leg ulcers. J Wound Care. 2023;32(11):704-718. https://doi.org/10.12968/jowc.2023.32.11.704 DOI: https://doi.org/10.12968/jowc.2023.32.11.704

Padula WV, Ramanathan S, Cohen BG, Rogan G, Armstrong DG. Comparative Effectiveness of Placental Allografts in the Treatment of Diabetic Lower Extremity Ulcers and Venous Leg Ulcers in U.S. Medicare Beneficiaries: A Retrospective Observational Cohort Study Using Real-World Evidence. Adv Wound Care (New Rochelle). 2024;13(7):350-362. https://doi.org/10.1089/wound.2023.0143 DOI: https://doi.org/10.1089/wound.2023.0143

Desvigne M, Tettelbach WH, Davenport T, et al. Cellular, Acellular And Matrix-Like Products (CAMPS) In Pressure Injuries. J Wound Care. 2025;34(Sup12d):S1-S20. https://doi.org/10.12968/jowc.2025.34.Sup12d.S1 DOI: https://doi.org/10.12968/jowc.2025.34.Sup12d.S1

Tettelbach WH, Armstrong DG, Kapp D, Johnson J, Niezgoda JA, Dirks R, et al. Regulatory and reimbursement reform for cellular, acellular, and matrix-like products (CAMPs): expert opinion consensus document. International Journal of Tissue Repair. 2025. https://doi.org/10.63676/wjhaj519 DOI: https://doi.org/10.63676/wjhaj519

Tettelbach WH, Armstrong DG, Tucker T, et al. Rethinking regulatory tiers: Medicare real-world evidence shows CAMP outcomes are independent of FDA regulatory classification. J Wound Care. 2026;35(1):35-46. https://doi.org/10.12968/jowc.2025.0609 DOI: https://doi.org/10.12968/jowc.2025.0609

Tettelbach WH, Cazzell SM, Hubbs B, Jong JL, Forsyth RA, Reyzelman AM. The influence of adequate debridement and placental-derived allografts on diabetic foot ulcers. J Wound Care. 2022;31(Sup9):S16-S26. https://doi.org/10.12968/jowc.2022.31.Sup9.S16 DOI: https://doi.org/10.12968/jowc.2022.31.Sup9.S16

Lyder CH, Ayello EA. Pressure Ulcers: A Patient Safety Issue. In: Hughes RG (ed). Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008. Chapter 12. https://www.ncbi.nlm.nih.gov/books/NBK2650/ (accessed 10 March 2026)

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Published

2026-03-17

Data Availability Statement

Data that support the findings of this study are available from the CMS. Restrictions apply to the availability of these data—used under a data use agreement between Tiger Biosciences and CMS for the current study— and therefore are not publicly available. However, data may be available from the authors upon a reasonable request and with permission from CMS.

How to Cite

Real-world outcomes of cellular, acellular, and matrix-like products (CAMPs) in Stage 3 pressure injury ulcers: A matched Medicare claims analysis (2016–2024). (2026). International Journal of Tissue Repair, 2(1). https://doi.org/10.63676/dj8g4218