Submitted Comments
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.
May 27, 2022
The Alliance submitted detailed comments and recommendations FCSO on its Draft LCD on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL36377) and accompanying draft Local Coverage Article (DA57680). In April oral comments submitted at FCSO's public meeting, the Alliance had flagged - among other issues - concerns about several 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 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 its 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. See comments and attachments below.
April 29, 2022
The Alliance provided oral testimony at the April 29, 2022 public meeting to provide inputs to Novitas on its Draft LCD on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041).
For the purposes of this public meeting, the Alliance focused on four primary concerns:
1) Many of the statements and limitations in the policy do not have the scientific evidence to support them. Old evidence is cited and often the evidence cited contradicts statements in the policy that the evidence was used to support. 2) Utilization parameters in this draft LCD seem arbitrary, will negatively impact patient care and are not supported in the evidence provided by Novitas. 3) There is conflicting, confusing and/or incorrect information contained in the draft LCD which is not only problematic but at times also clinically incorrect. 4)The Alliance flagged significant procedural issues with the release of this draft LCD - as Novitas did not engage any stakeholders nor convene a meeting of its CAC to create questions and discuss the evidence for this draft LCD. The Alliance's perspective will be expanded in submitted written comments.
For the purposes of this public meeting, the Alliance focused on four primary concerns:
1) Many of the statements and limitations in the policy do not have the scientific evidence to support them. Old evidence is cited and often the evidence cited contradicts statements in the policy that the evidence was used to support. 2) Utilization parameters in this draft LCD seem arbitrary, will negatively impact patient care and are not supported in the evidence provided by Novitas. 3) There is conflicting, confusing and/or incorrect information contained in the draft LCD which is not only problematic but at times also clinically incorrect. 4)The Alliance flagged significant procedural issues with the release of this draft LCD - as Novitas did not engage any stakeholders nor convene a meeting of its CAC to create questions and discuss the evidence for this draft LCD. The Alliance's perspective will be expanded in submitted written comments.
April 28, 2022
The Alliance provided oral testimony at the April 28, 2022 public meeting to provide inputs to FCSO on its Draft LCD on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL36377). In its brief oral comments, the Alliance focused on four primary concerns: (1) Many of the statements and limitations in the policy do not have the scientific evidence to support them; Old evidence is cited and often the evidence cited contradicts statements in the policy that the evidence was used to support. (2) Utilization parameters in this draft LCD seem arbitrary, will negatively impact patient care and are not supported in the evidence provided by FCSO. (3) There is conflicting, confusing and/or incorrect information contained in the draft LCD which is not only problematic but at times also clinically incorrect. (4) There are procedural issues with the release of this draft LCD as FCSO did not engage any stakeholders nor convene a meeting of its CAC to create questions and discuss the evidence for this draft LCD. The Alliance's perspective will be expanded in submitted written comments to FCSO.
April 26, 2022
The Alliance submitted detailed responses to the questions posed by the FDA as it sought feedback and input heading into its April 28-29, 2022 Wound Healing Scientific Workshop. The Alliance provided responses to FDA's questions for wound care providers, questions for product developers/researchers and questions specific to reimbursement. Alliance staff, and many of our members, not only attended the virtual conference, but also participated as speakers.
See Alliance responses to FDA questions
See Alliance responses to FDA questions
April 3, 2022
The Alliance submitted a follow-on letter to CMS and its National Correct Coding Initiative (NCCI) Contractor continuing to urge consideration of our requests for edits. While through our advocacy efforts we successfully achieved an update to the NCCI manual in 2021 allowing for debridement and compression to be provided on the same day, the correlating changes to the edits table were not made at that time. The Aliance has again advocated for this change, emphasizing that "making this change without deleting the corresponding procedure-to-procedure edits does not sufficiently address the problem of Medicare beneficiaries being denied access to these important, limb and life-saving services. With the edits still in place, providers are discouraged from performing both services when performed on the same limb, despite the fact they are completely separate services with no overlap in the time, work, effort, or risk associated with the performance of the two. Making the above changes without deleting the corresponding procedure-to-procedure edits has caused confusion [and] uncertainty regarding how to interpret this." Together with the letter the Alliance submitted a table of the existing edits and our requested corrections so that the language in the Policy Manual be consistent with the edit table.
March 15, 2022
On March 15, the Alliance met with three divisions of CMS – Hospital and Ambulatory Policy Groups (Division of Practitioner Services and Division of Outpatient Care), Technology Coding and Pricing Group (Division of Coding and DRG) – to discuss how the inconsistent HCPCS code assignments for CTPs ("skin substitutes") have led to problematic issues in both the physician office setting and in hospital outpatient provider-based departments. The Alliance alerted CMS to the unintended consequences in the physician’s office and the hospital outpatient provider based departments when CMS began assigning “A” and “C” codes instead of the traditional Q codes to skin substitutes, and presented six specific recommendations for CMS consideration to bring consistency to coding for CTPs and synthetic CTPs and correct the unintended impacts being experienced under current coding policies. We called on the Agency to bring consistency to coding for CTPs and synthetic CTPs and correct the unintended impacts being experienced under current coding policies.
To illustrate how the impact of decisions made in one division impacts the others, the Alliance also provided to CMS a detailed chart showing the chronology of skin substitute policies, providing context and timelines as to how HCPCS coding decisions have impacted the physician fee schedule and hospital outpatient policies. See Alliance presentation, recommendations and CTP policy chart below.
To illustrate how the impact of decisions made in one division impacts the others, the Alliance also provided to CMS a detailed chart showing the chronology of skin substitute policies, providing context and timelines as to how HCPCS coding decisions have impacted the physician fee schedule and hospital outpatient policies. See Alliance presentation, recommendations and CTP policy chart below.
