Submitted Comments

November 4, 2022
The Alliance submitted feedback to CMS' Request for Information seeking public input on accessing healthcare and related challenges, understanding provider experiences, advancing health equity, and assessing the impact of waivers and flexibilities provided in response to the COVID-19 Public Health Emergency. The Alliance focused on the profound healthcare disparities in the outcome of chronic wounds – which disproportionately affect minority populations, and primarily affect persons with multiple comorbid conditions. Comments highlighted specific policy issues in the wound care space that negatively impacting access to care and offered recommendations and policy fixes to address these issues. Addressing the Agency's request for input on COVID 19 PHE Waivers and Flexibilities, the Alliance also specifically provided a wound care perspective on areas including telehealth and remote patient monitoring.

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October 26, 2022
The Alliance elevated its concerns with CGS's proposed LCD/LCA on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers by providing oral testimony at the Medicare Administrative Contractors' public meeting. The Alliance emphasized its concern that a thorough evaluation and independent review of the evidence had not been undertaken by CGS, as this LCD mirrors the recently-issued Novitas and FCSO LCDs. The Alliance focused its comments on four main areas of concern.
  1. Many of the statements and limitations in the policy do not seem to have the scientific evidence to support them.
  2. Utilization parameters in the draft LCD seem arbitrary, will negatively impact patient care and are not supported in the evidence provided.
  3. There is conflicting/confusing information contained in the draft LCD that in some cases is clinically incorrect.
  4. There are significant procedural issues with the process in which the draft LCD was developed and released.
See the Alliance's full testimony and accompanying slides below. 

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September 24, 2022
The Alliance sent a letter to Guidewell Source, the parent company of Medicare Administrative Contractors Novitas Solutions and First Coat Service Options, requesting that the two MACs withdraw their proposed  LCDs on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041 and DL36377) and the accompanying Local Coverage Articles (DA54117 and DA57680). "As the parent company to both Novitas and FCSO, we are calling to your attention that statements in the draft LCDs and LCAs are contrary to wound care clinical practice guidelines and scientific research and they also violate several aspects of statutory and regulatory laws... the Alliance strongly recommends that this policy be withdrawn before it negatively impacts patient care."

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September 23, 2022

When Novitas and First Coast Service Option re-issued for comment draft LCDs (DL35041 / DL36377) and LCAs (DA54117 / DA57680), the Alliance questioned why little previously-provided stakeholder input was reflected in the re-posted policies. “We identified many issues in our oral testimony given at April and August 2022 public meetings and in our extensive comments dated May 27. Therefore, it is baffling that First Coast and Novitas have reissued the same draft policies – without taking into consideration ANY of our or other stakeholders’ comments,” the Alliance wrote in its most recent comments submitted to the MACs in September The Alliance again took issue with the shift of 40+ products from the covered to non-covered list, flagged numerous clinical inaccuracies, and recommended that the MACSs withdraw these draft LCD/LCAs and work with their Carrier Advisory Committees (CACs) and stakeholders to craft a more accurate policy.

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September 13, 2022
The Alliance submitted comments to CMS' proposed CY 2023 Hospital Outpatient Prospective Payment System expressing significant concerns with several provisions within the "skin substitute" section of the proposed rule. In its detailed feedback to CMS, the Alliance:  
  • Opposed CMS' renaming the term "skin substitutes" to "wound care management products."
  • Opposed CMS' proposal to change CTP's HCPCS codes from “Q” codes to “A” codes (supply codes). Called out some of the concerning cross-over issues from the proposed 2023 Physician Fee Schedule and recommended that the Agency publish ASPs and continue to accept ASP pricing for inclusion in payment methodology for all CTPs in order to achieve savings and consistency.
  • Urged CMS to remove patient access barriers by correcting inadequacies in CTP payments. The Alliance once again submitted the recommendation that CMS make policy updates to (1) Enable Provider-Based Departments to be reimbursed for an adequate amount of CTP products for larger wounds and (2) Equalize payment for the application of CTPs wounds of the same size, no matter where they are on the body.

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September 6, 2022
In comments to CMS's draft 2023 Physician Fee Schedule, the Alliance alerted the Agency that the proposed changes to reclassify all CTPs as “supplies incident to a physician service” and package payment into practice expenses will create barriers to care that could ultimately lead to increased amputations and infection for patients with chronic non-healing wounds. The Alliance urged CMS to remove the proposed CTP provisions from the final 2023 Physician Fee Schedule that will issue later this year, or, at very least, delay implementation until patient access issues can be further studied and policy implications vetted with key stakeholders.

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August 25, 2022
The Alliance made its voice heard to First Coast Service Option and Novitas by providing oral testimony at the Medicare Administrative Contractors' public meetings to collect stakeholder input on their draft LCDs and LCAs on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. One of 15 presenters specifically providing oral comments on these policies, the Alliance reiterated recommendations expressed in its April comments and May comments, and questioned why no inputs had been addressed. "If First Coast and Novitas were interested in further comments, then releasing a draft policy taking into consideration our already provided comments would have been a more useful exercise," the Alliance said, reminding the MACS of the key focus of our previously submitted comments: Many of the statements and limitations in the policy do not have the scientific evidence to support them, arbitrary utilization parameters, and clinically incorrect information in the policies

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August 11, 2022
The Alliance submitted comments to CMS's proposed 2023 Home Health Prospective Payment System Rate Update focused on gaining clarity to provisions related to Lymphedema. The Alliance also urged the Agency not to make many of its proposed cuts in payment to home health agencies. "Since the pandemic has started, home health providers took on the brunt of patient care. Their work load went up exponentially."

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July 19, 2022
Together with more than 20 other members of the Clinical Labor Coalition, the Alliance co-signed a letter to Members of Congress expressing concerns about the significant cuts in physician reimbursement as part of the proposed 2023 Physician Fee Schedule. The cuts in the proposed rule "undermine the long-term financial viability of physician practices and seniors’ access to critical treatments and procedures, by implementing significant cuts in physician reimbursement. Community-based office setting specialty care is a critical part of the nation’s healthcare infrastructure, and we are certain CMS’ reimbursement policy will have repercussions for the future, impacting access and value." The letter, posted below, urged Congress to begin immediate deliberations to identify and advance policies to mitigate the forthcoming reimbursement cuts. 

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June 28, 2022
The Alliance submitted a second set of comments to the FDA following its April Wound Healing Workshop. Our first set of comments were submitted right before the April 28-29 Workshop in response to the Agency's request for information heading into the meeting. Those comments centered around answering the questions FDA posed related to providers, product developers/researchers and reimbursement.
This second set of comments addressed the consistent themes from both the FDA Wound Healing Workshop and the Alliance of Wound Care Stakeholders Wound Care Evidence Summit™ as well as provided recommendations for the FDA to consider adopting. Topics addressed in these comments include: Real world data/real world evidence; primary and secondary clinical endpoints; funding of clinical trials; mechanisms for modifying and expanding claims, new technology innovations in wound care and. more

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