Submitted Comments
May 1, 2017
The Alliance provided oral testimony at the Wisconsin Physician Services (WPS) public meeting on its draft wound care LCD (DL37228). The Alliance voiced concern that WPS has created arbitrary parameters without clinical or scientific basis. In its submitted comments, the Alliance requested that WPS provide the evidence for the utilization parameters identified with respect to debridement as well as Negative Pressure Wound Therapy (NPWT).
March 9, 2017
The Alliance submitted comments to FCSO’s wound care draft LCD (DL37166). Comments noted that the LCD lacked a foundation in medical evidence and clinical practice guidelines in regards to utilization parameters for both debridement and NPWT. Furthermore, the Alliance noted that the LCD lacks sufficient evidence for the change in coverage for disposable negative pressure (dNPWT) products. The Alliance expressed concerned that FCSO may be using problematic proprietary claims data as a rationale in crafting this policy. The comments also pointed to inaccurate information and confusing/conflicting language found throughout the policy.
March 9, 2017
The Alliance submitted comments to Novitas Solutions on wound care draft LCD (DL35125). Comments noted that the LCD lacks compelling medical evidence and clinical practice guidelines support for the utilization parameters proposed for debridement and negative pressure wound therapy (NPWT). The Alliance also expressed concern about the changes in coverage for disposable NPWT (dNPWT). The comments point out that FCSO may be relying on problematic proprietary claims data as a main source in crafting the draft regulation. The comments also note inaccurate information and confusing/conflicting language found throughout the policy.
March 9, 2017
The Alliance submitted comments to Novitas Solutions on draft LCD (DL34924) regarding the treatment of varicose veins of the lower extremities. Alliance comments support those submitted by the American College of Phlebology and the American Venous Forum and Society of Vascular Surgeons. Each of these groups expressed concern that the proposed regulation arbitrarily limits access to care for patients with clinically significant disease and selectively applies certain clinical practice guidelines while ignoring others. The Alliance expressed concerns that the draft LCD goes against prior LCDs from other Medicare administrative contractors (MACs) as well as most commercial carriers.
February 16, 2017
The Alliance provided oral testimony at the FCSO public meeting on wound care LCD (DL37166). Testimony focused on: the lack of coverage for disposal negative pressure wound therapy (dNPWT); utilization parameters proposed for NPWT; utilization guidelines that limited debridement; and concerns with policies surrounding the application of Unna Boots or a multi-layer compression system.
January 26, 2017
The Alliance provided oral testimony at the Novitas Solutions public meeting convened to collect feedback on its wound care LCD (DL35125). Alliance testimony focused on several key issues: the lack of coverage for disposal negative pressure wound therapy (dNPWT); utilization parameters proposed for NPWT that are not based on evidence or clinical practice; utilization guidelines that limited debridement; and concerns with policies surrounding the application of Unna Boots or a multi-layer compression system.
December 19, 2016
The Alliance submitted comments to CMS on its rule: Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models. Comments focused on ensuring that CMS considered of the impacts of the evolving value-based care/payment reform policies to wound care. The Alliance submitted comments to MACRA's quality physician payment proposed rule as well as on the "quality measures development plan," "patient relationships categories and codes," and "episode groups" draft policies.
November 21, 2016
The Alliance submitted detailed comments advocating that solid wound dressings combined with drugs that are formulated as cream, gel, or ointment, should be classified as Class II with special controls, following FDA's Sept. 16, 2016 advisory committee meeting on the issue. The Alliance also expressed its agreement with the FDA's use of multiple product classification categories for antimicrobial products currently regulated in the FRO category (i.e., solids, cream/gel/ointment and liquid washes). The Alliance clarified that the wound care products in the FRO category containing such items as silver, PHMB, Cadexomer iodine and honey under discussion at the Panel meeting should be categorized as antiseptics and do not appear to contribute to antibiotic resistance. These comments build on the previous comment the Alliance submitted in advance of the September FDA panel meeting, and clarify that antimicrobial wound care dressings are not intended to treat or heal the wound. Instead the specific claims made in the labeling for these products include: maintain a moist wound environment, covers and protects the wounds, provides a barrier to penetration of microbes to the wound, which may reduce the risk of infection, etc.
October 24, 2016
The Alliance submitted comments to the FDA on its draft guidance "Use of Real World Evidence to Support Regulatory Decision-making for Medical Devices." The Alliance voiced support for the use of data from registries, claims, and electronic health records when evaluating medical devices. Comments also addressed the limitations of randomized clinical trials in evaluating the effectiveness of a wound care product. The Alliance provided specific examples of how registry data could be used in assessing the safety of a wound care medical device.
September 27, 2016
The Alliance submitted comments to the FDA draft guidance "Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products." Comments identified specific areas of the regulation that needed additional clarity and alignment across guidances in order to make them clinically meaningful, accurate, and consistent with - rather than contradictory to - existing regulations.
