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

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.