Submitted Comments
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The Alliance submitted comments to the FDA on its draft guidance "Use of Real World Evidence to Support Regulatory Decision-making for Medical Devices."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The Alliance submitted comments to the FDA draft guidance "Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products."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.
September 27, 2016
The Alliance submitted comments to the FDA on its "Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products - draft guidances for industry and FDA staff." The Alliance highlighted a number of issues with regard to "main function" and "basic function" terminology in the guidance. Comments also identified multiple inconsistencies between the "Minimal Manipulation" guidance and the "Homologous Use" guidance. The Alliance encouraged the FDA should work with stakeholders to develop an appropriate guidance document that is consistent with guidances and current regulatory language and that provides needed clarity.
September 12, 2016
The Alliance delivered oral comments at the FDA's September 2016 Public Hearing on Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products. The Alliance express concern with the narrow definition of homologous use of amnion tissue and how that will impact wound care, as there are many basic functions of amniotic tissue that should be used for wound healing. The Alliance noted that there are many significant new requirements within the minimal manipulation document which not only conflict with the homologous use document, they conflict with current regulatory language.
September 6, 2016
The Alliance submitted comments to CMS on the CY 2017 Hospital Outpatient Prospective Payment System noting that no measures in the Hospital Outpatient Quality Reporting program are specific to wound care. The Alliance reminded CMS that there are 21 quality measures specific to the practice of wound care, fully programmed, as electronic clinical quality measures available within the U.S. Wound Registry Qualified Clinical Data Registry. Furthermore the Alliance expressed concerns on the flawed methodology CMS uses to calculate the payment for cellular and tissue-based products for wounds (CTPs, referred to in the policy as skin substitutes).
September 6, 2016
The Alliance submitted comments to CMS on its proposed Physician Fee Schedule update: "CMS-1654-P: Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model." Alliance comments focused on wound care services it viewed as improperly/inaccurately valued by the fee schedule. The Alliance also called for increased transparency on how CMS will use global service data. Additional, the Alliance requested that CMS review its criteria for the expansions of the upcoming Diabetes Prevention Program model as the Medicare Diabetes Prevention Program (MDPP).
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 product 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
August 29, 2016
The Alliance submitted comments to CMS’s proposed rule “Medicare 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.
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.
