The hidden costs of limiting access: clinical and economic risks of Medicare's future effective cellular, acellular and matrix-like products (CAMPs) Local Coverage Determination.

Abstract

Objective: To evaluate the impact of Medicare's future effective Local Coverage Determination (LCD) for cellular, acellular and matrix-like products (CAMPs), which, while informed by a literature review and expert input, was finalised without incorporating a detailed statistical or cost analysis of its projected clinical and economic impact across diverse wound care delivery settings (e.g., hospital-affiliated, private practice, and post-acute care). This analysis focuses on the clinical consequences for Medicare beneficiaries with chronic or hard-to-heal lower extremity diabetic ulcers (LEDUs) and venous leg ulcers (VLUs). Additionally, it aims to assess the economic implications of implementing a capitated or fixed-fee schedule on CAMPs' use, Medicare expenditures and associated medical outcomes.

Method: A review of retrospective analyses of Medicare claims (2015-2020) was conducted, comparing treatment outcomes for LEDUs and VLUs using CAMPs plus medically accepted standard of care (SoC) versus SoC without CAMPs. Clinical endpoints included rates of hard- to-heal ulcer healing, amputation rates, hospitalisations and healthcare resource use. Cost-effectiveness models evaluated the impact of CAMP reimbursement structures on overall Medicare costs. Analysing the impact of a fixed-fee schedule involved evaluating Medicare claims data from 2016-2023 to determine the number of commercially available CAMPs, along with the most up-to-date average sales price (ASP). A comparative cost analysis model using an activity-based costing approach and a prospective payment system comparison was applied to evaluate two distinct reimbursement structures: an ASP fee-for- service model versus a fixed-fee schedule model.

Results: Medicare beneficiaries receiving SoC plus CAMPs for stalled wounds demonstrated significantly lower amputation rates, reduced hospitalisations and improved wound healing times compared with those receiving SoC without a CAMP during the episode of care. Beneficiaries receiving CAMPs also realised annual cost savings of $3670 USD per patient and a five-year net benefit of $5003 USD per patient. When evaluating over a 12-month window, restricting CAMPs to eight applications in the treatment of hard-to-heal VLUs and LEDUs resulted in estimated treatment failure rates of 10.9% and >30%, depending on the area of investigation. Moreover, the non-real-world restriction of a 16-week treatment episode in the future effective CAMP LCD, which fails to account for care delays (e.g., cellulitis, hospital admissions), will likely drive treatment failure rates even higher. Among failed LEDU cases receiving a CAMP, 1% require an amputation at a reimbursement rate of $23,435 USD per case, 37% are readmitted at a rate of $2079 USD per admission, and 30% seek emergency care at a reimbursement rate of $8292 USD per visit. These complications could result in hundreds of millions of dollars in additional annual Medicare expenditures, eroding any expected savings from the future effective CAMP LCD. Implementing a fixed CAMPs fee schedule instead of the traditional ASP reporting system could potentially reduce Medicare expenditures on CAMPs by >51% while still enabling wound care providers to determine medical necessity on evidence-based decision-making.

Conclusion: The proposed CAMPs LCD could negatively impact outcomes for Medicare beneficiaries who experience adverse outcomes when treatment is prematurely limited to eight applications over a fixed 16-week episode of care. While this subset of patients represents a relatively small proportion, they are at high risk of costly complications, which are likely to escalate when effective and medically necessary CAMPs treatment, ordered, selected and applied by their healthcare provider, is denied. Implementing a fixed-fee schedule for CAMPs without an absolute eight-application cap could enhance access by allowing healthcare providers to treat a greater proportion of hard-to-heal ulcers to closure with the goal of limb preservation, while maintaining cost controls. Policy adjustments should incorporate real-world evidence demonstrating the effectiveness of CAMPs rather than relying solely on randomised controlled trials.