Wound Care Physicians, Experts Express Concerns Over the Potential Unfavorable Impact on Patient Care Resulting from the Proposed Draft Cellular, Acellular and Matrix-Like Products (CAMPs) Local Coverage Determinations (LCDs)

METAIRIE, La.--(BUSINESS WIRE)--On April 25, 2024, the following Medicare Administrative Contractors (MACs), CGS Administrators, First Coast Service Options, National Government Services, Noridian Healthcare Solutions, Novitas Solutions, Palmetto GBA and WPS Insurance Corporation, each proposed an ill-drafted Local Coverage Determination (LCD), titled Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Lower Extremity Diabetic Ulcers (LEDUs) and Venous Leg Ulcers (VLUs).

The MACs policy, if adopted in its current form, will cut coverage for over 100 essential skin substitutes, also referred to as cellular, acellular and matrix-like products (CAMPs), and limit treatments to four applications per wound ,which is unacceptable, misaligned with medical standards of care, harmful to patients and neglectful of beneficiaries well-being.

An alarming aspect of the proposed LCD is that it prioritizes the reduction of excessive use of skin substitutes rather than encouraging the adoption of best practices by physicians which would ultimately lead to improved clinical outcomes for their Medicare beneficiaries. Recently, there have been multiple published studies analyzing Medicare claims data from 2015 to 2020 which demonstrates the capability of CAMPs to decrease amputation rates, mitigate overall healthcare costs and, even more dramatic, reduce mortality rates:

• 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 Jul 1;30(Sup7):S5-S16. https://doi.org/10.12968/jowc.2021.30.Sup7.S5. PMID: 34256590
• Tettelbach WH, Armstrong DG, Chang TJ et al. Cost-effectiveness of dehydrated human amnion/chorion membrane allografts in lower extremity diabetic ulcer treatment. J Wound Care. 2022 Feb 1;31(Sup2):S10-S31. https://doi.org/ 10.12968/jowc.2022.31.Sup2.S10. PMID: 35148642
• Tettelbach WH, Driver V, Oropallo A et al. Treatment patterns and outcomes of Medicare enrolees who developed venous leg ulcers. J Wound Care. 2023 Nov 2;32(11):704-718. https://doi.org/10.12968/jowc.2023.32.11.704. PMID: 37907359
• Tettelbach WH, Driver V, Oropallo A et al. Dehydrated human amnion chorion membrane to treat venous leg ulcers: a cost-effectiveness analysis. J Wound Care. 2024 Mar 1;33(Sup3):S7. https://doi.org/ 10.12968/jowc.2024.33.Sup3.S7. PMID: 38457298
• Padula WV, Ramanathan S, Cohen BG et al. 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 Apr 8. https://doi.org/10.1089/wound.2023.0143. Epub ahead of print. PMID: 38588554.

The LCD also removed the ability to treat wounds beyond LEDUs and VLUs by excluding the option to treat them based on ‘medical necessity.’ For practicing healthcare providers, medical necessity is still an evidence-based, decision-making process bolstered by training and clinical experience. As the proposed LCD stands today, a non-diabetic patient with idiopathic peripheral neuropathy who presents with a diabetic-like neuropathic ulcer, which has been refractory to standard of care and is at an increased risk of amputation, will no longer be allowed to be treated with a CAMP based on ‘medical necessity.’

“The proposed LCD will exclude the majority of patients residing in skilled nursing facilities or home bound patients from receiving life changing treatment with a CAMP since the usual hard-to-heal wound type in these settings are neither VLUs nor DFUs,” commented Dr. William H. Tettelbach, a practicing wound care physician and Chief Medical Officer of RestorixHealth. “Given these restrictions, combined with the inability to treat patients based on medical necessity, wound care providers will be stripped of their ability to offer a clinically proven technology to heal their post-acute care patients suffering with chronic wounds.”

In contrast, infectious disease specialists successfully treat infections routinely with antibiotics that do not have an established indication for the targeted diagnosis, especially when other options fail or are unavailable. Given all the existing medical evidence, which appears to have been ignored or misinterpreted by the MACs during the development of the proposed LCD, the authors should reconsider their stance on excluding the option of medical necessity, which, if included, would allow frontline providers to combine their clinical experience with evidence-based decision-making, thus enabling them to strive for best practices in all clinical settings.

It would be prudent for the Medical Directors of the MACs to take the time to review the open letter to the MACs for consideration authored by Dr. William Tettelbach, Martha Kelso and Dr. David Armstrong, which was published online on June 7, 2024, in the Journal of Wound Care.

It is crucial to recognize that Medicare's proposed 'one-size-fits-all' therapy approach is not only misguided but also potentially harmful. Each patient is unique, and their wounds require individualized care. Medicare's attempt to dictate which products will and won’t work and to limit access to potentially life-saving therapies is a grave concern.

About RestorixHealth

Committed to excellence in wound care, RestorixHealth is the wound care solutions company providing programs, services, products and education across the care continuum. From developing and operating wound centers in partnership with hospitals, to delivering professional wound care in nursing facilities and in-home settings, RestorixHealth’s solutions increase access to care, reduce hospital admissions and most importantly, improve patient outcomes and quality of life. For more information, visit www.RestorixHealth.com.