Submitted Comments
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.
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.
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.
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
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."
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.
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
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
June 27, 2022
The Alliance improved CMS’ understanding of CTPs and their use in real-world clinical practice via an educational seminar customized to key CMS senior policymakers and staff who oversee policies guiding HCPCS coding, the physician fee schedule and hospital outpatient payments. This meeting was the direct result from our March meeting with CMS staff to elevate CTP issues and Alliance recommendations. The June 27 educational session was attended by six CMS Directors or Deputy Directors along with 18 senior staff from these distinct divisions of the Agency: Hospital and Ambulatory Policy Groups (Division of Practitioner Services, Division of Outpatient Care, Division of Ambulatory Services); Technology Coding and Pricing Group (Division of Coding and DRG; Division of Data Analysis and Market Based Pricing); Chronic Care Policy Group (Division of Home Health and Hospice); and Center for Clinical Standards and Quality (Coverage and Analysis Group. In addition to providing much needed education about CTPs and their use, we also took advantage of the advocacy opportunity to demonstrate the unintended impacts being experienced by clinicians and patients under current coding policies and called on the Agency to bring consistency to coding for CTPs and synthetic CTPs. See the slides that guided our presentation and our recommendations to CMS, below.
June 14, 2022
The Alliance submitted comments to the FY 2023 Hospital Inpatient Prospective Payment System (IPPS) proposed rule, specifically supporting the inclusion of Global Malnutrition Composite Score (NQF #3592) in the proposed policy and recommending that CMS move forward with implementing the NQF #3592 Global Malnutrition Composite Score for the Hospital Inpatient Quality Reporting Program.
May 27, 2022
The Alliance submitted detailed comments and recommendations to Novitas on its Draft LCD on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041) and accompanying draft Local Coverage Article (DA54117). In April oral comments submitted at Novitas' public meeting, the Alliance had flagged - among other issues - provisions in the policy not supported by scientific evidence, as well as conflicting and/or clinically incorrect policy language. In written comments, the Alliance submitted a chart (attachment A) detailing the specific provisions/policy language it flagged as problematic, the issues of concern underlying to those provisions, specific language changes to address the concern, and the clinical evidence supporting these recommendations. The chart was accompanied by additional attachments, including HCPCS and ICD-10 Codes to be added and a red-lined mark-up of suggested line edits (attachments B-E). See comments and attachments below.
