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)
June 18 2024 - 10:00AM
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.
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