Submitted Comments

September 1, 2016
The Alliance submitted comments to the FDA's General and Plastic Surgery Panel of the Medical Devices Advisory Committee in advance of the panel's September 2016 meeting. The Alliance emphasized that the products that are currently in the FRO category are low to moderate risk, have been in the marketplace for many years, and should be classified by the FDA into either Class I or Class II, most remaining subject to 510(k). The Alliance comments gave perspective on the issue, addressing the following:
  • An overview of wound care relating to the FRO product category
  • The science behind management of chronic wounds
  • Management of chronic wounds using antimicrobial wound care products
  • Products classified in the FRO product category, their indications for use and testing
  • Evidence for safety and effectiveness of products in FRO category/ Low-moderate risk of antimicrobial resistance
View Alliance Comment 
August 29, 2016
The Alliance submitted comments to CMS’s proposed ruleMedicare Program; Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures.”  Comments noted the Alliance’s concern that the MACs (Medicare Administrative Contractor) and Qualified Independent Contractors (QIC) are not equipped to appropriately apply precedential decisions,” and raised concerns about many contractors’ inaccurate application of LCD and NCD criteria. The Alliance recommended that CMS create a process to review and reject outdated precedents and suggested that CMS create a process for interested parties to challenge existing precedent. Additionally, the Alliance suggested that all Medicare providers and contractors be trained and educated by CMS on the proper procedures governing precedential cases. The Alliance recommended that CMS provide its contractors with a summary of each case precedent to simplify the process of applying precedent to future appeals.
View Alliance Comments
August 25, 2016
The Alliance submitted comments to CMS on its proposed policy update “CY 2017 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements.” Alliance comments focused on the proposed rule’s implementation of the newly created statutory benefit to pay home health agencies separately for disposable Negative Pressure Wound Therapy (NPWT). The Alliance requested that the Agency clarify the section regarding payment for the time that the home health agency provides the disposable NPWT. The Alliance recommended that in addition to paying for the disposable NPWT devices, CMS also pay the home health agency the nursing time and travel for initial and subsequent visits to those patients requiring home health services who can benefit from the use of disposable NPWT.
View Alliance Comment
August 12, 2016
The Alliance submitted comments to CMS’s on its draft policy on Patient Relationship Categories and Codes. Comments noted that the proposed rule puts another burden on the clinician for tracking, coding and documentation but adds no value to patient care, or treatment outcomes. The Alliance emphasized to CMS that currently under MIPS, there are no quality measures that a wound care clinician can report for the actual wound care treatment they perform. As such, the obligatory reporting of quality, resource use, and clinical performance measures may not truly be indicative of neither the wound care work wound care practitioners do nor of the resources that they use to treat their patients. Thus, resource use for any wound care clinician will be skewed until this issue is resolved. The Alliance suggested that the Patient Relationship Categories and Codes rule be delayed at least unto 2018 or beyond to allow clinicians sufficient time to adjust to all the other MACRA and MIPS documentation and reporting changes and challenges.
View Alliance Comment
August 8, 2016
The Alliance submitted comments to Cigna Government Services (CGS) on Local Coverage Determination (LCD) for Application of Skin Substitute for Wounds of Lower Extremities (DL36690). The Alliance reminded CGS that the term “skin substitutes” is clinically inaccurate and should be replaced with more inclusive descriptor “Cellular and/or tissue based products for wounds (CTPs).” The comments addressed issues in the draft policy related to the classification of products, utilization instructions, coverage limitations and confusing language in the guidance regarding its distinction when providing coverage for diabetic foot ulcer (DFU) vs. venous leg ulcer (VLU). Comments also highlighted the need for CGS to recognize podiatrists as providers who can and do treat patients with wounds, and the indications for use (IFUs) for products affected by the LCD. 
View Alliance Comment
August 5, 2016
The Alliance submitted comments to Noridian on Local Coverage Determination (LCD) for Hyperbaric Oxygen (HBO) Therapy (DL 36686). The Alliance recommended that Noridian revise the policy to recognize the implicit coverage of skin grafts and flaps and expressed concern about the policy’s wording around adjunctive treatment of the diabetic foot ulcer (DFU). Comments also flagged several areas in the draft policy in which Noridian provided specific dose and frequency parameters that are contrary to current standards of practice. In addition, the Alliance noted that some of the evidence that Noridian has used to substantiate the provisions in this policy is outdated. 
View Alliance Comment
August 3, 2016
As member of the Venous Care Partnership, the Alliance submitted comments to the Agency for HealthCare Research and Quality (AHRQ) on the June 28, 2016 Technology Assessment (TA), “Treatment Strategies for Patients with Lower Extremity Chronic Venous Disease (LECVD).” The comments expressed concern about that the assessment relied solely on research published after the year 2000, as the diagnosis and treatment of venous diseases has a long history and much of the evidence supporting the diagnosis and treatment of venous disease was established before the limited time period covered by this review. 
View Alliance Comment
May 9, 2016
The Alliance submitted comments to CMS on the Medicare Program; Part B Drug Payment Model stating that it “disagrees with a broad sweeping change to the payment methodology for drugs and biologics…since there is no evidence to support the change.” The Alliance noted that it believes that the proposed rule focuses solely on costs rather than on the complexities of patient care. The Alliance urged CMS to go through a formal rulemaking process for Phase 2 instead of a sub-regulatory process – which is insufficient due to the complexity of the models being developed. 
View Alliance Comment
March 1, 2016
The Alliance submitted comments to CMS on MACRA Episode Groups. In its comments, the Alliance reported that chronic wounds and ulcers are reaching epidemic proportions in the United States. Despite their prevalence, this problem remains off the CMS radar screen even though Medicare will devote at least $30 billion dollars to their treatment this year (and by some estimates, twice that amount). The Alliance urged CMS to create episodes of care around the following high resource use conditions:
  • Diabetic foot ulcers
  • Venous stasis ulcers
  • Stage 3 and 4 pressure ulcers
View alliance comment
March 1, 2016
The Alliance submitted comments to CMS on its Quality Measure Development Plan. The Alliance emphasized chronic wound care’s significant economic burden to Medicare and other health care payers. The Alliance encouraged CMS to also adopt measures used in Qualified Clinical Data Registries (QCDR) while also utilizing those under PQRS.
VIEW ALLiance Comment
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