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Updated: Oct 10, 2026

Large-Scale Cell Production Based on GMP-Grade Dissolvable Porous Microcarriers
Published on: July 7, 2023
Consensus guidelines on optimal sizing, administration and documentation of cellular, acellular and matrix-like
Windy Cole1, Shaun Carpenter2, Abigail Chaffin3
1Chair, Director of Wound Care Research, Kent State University College of Podiatrie Medicine, Independence, OH.
Abstract:
In January 2026, the Centers for Medicare & Medicaid Services (CMS) reclassified cellular, acellular and matrixlike products (CAMPs) from 'biologicals' to 'incident-to supplies' under Medicare Part B, introducing a flat-fee reimbursement model. However, there was clinical ambiguity regarding the definition, measurement and documentation of administered and discarded product. This uncertainty has increased audit risk and been associated with reduced confidence among providers in appropriate CAMPs use. In February 2026, a multidisciplinary US panel of wound care and reimbursement specialists convened to establish reco mmendations for CAMPs use consistent with current Medicare policy, addressing three domains: correct clinical use, comprising adequate patient preparation and need for CAMP to conform to both the internal surface area of the wound and an external fixation edge, which combined constitute the therapeutic treatment area (TTA); need for use of drape tracing with planimetry or three-dimensional digital imaging to accurately measure the TTA; and importance of comprehensive documentation of medical necessity and the amount of administered and discarded product, using CMS-aligned terminology. The panel states that traditional length-by-width multiplication is insufficient to measure the TTA.
