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Alliance members speaking at Sept 2016 FDA meeting on antimicrobial products; Alliance members speaking at Alliance seminar on “Current State of World Wound Care” at Sept 2016 World Union of Wound Healing Societies meeting

2016 Activities & Accomplishments

With the ongoing shifts in the U.S. healthcare landscape under a new Presidential administration, the unpredictable future of the Affordable Care Act, and the implementation of Medicare payment reform, having a voice in draft policies and regulations to represent a unified wound care perspective is of increasing importance. The Alliance’s 2016 work focused not only on the regulatory guidances and local coverage determinations that we’ve always focused on, but also on the value-based care payment initiatives that are dramatically changing the U.S. healthcare delivery system. We identified and took advantage of multiple opportunities for input, advocacy and comment. We worked tirelessly to ensure that regulatory agencies were aware of the issues and impacts to wound care as policies were crafted and considered. Our comments put us “on the record,” build credibility and open doors for ongoing advocacy and dialogue. Our visibility at key meetings and proactive conversations on targeted issues strategically continue to entrench the Alliance as an effective communicator on wound care issues and key “go-to” resource for government agencies and policy makers.

Several of our key accomplishments in 2016 include:
  • Elevated visibility of wound care issues with a united, proactive wound care voice to CMS as it refined regulations guiding implementation of the Medicare Access and CHIP Reauthorization Act (MACRA).
  • Demonstrated the clinical and economic expenditure impact of chronic wounds to CMS.
  • Played an effective, impactful role educating the FDA and its Advisory Panel by providing the relevant information and perspective which allowed the Panel to vote to recommend to the FDA that antimicrobial wound dressings should be classified as “Class II (with special controls),” thus protecting access and availability of antimicrobial wound care dressings for patients and providers.
  • Ensured wound care clinical community concerns were articulated to CMS by submitting comments to the Agency’s proposed rules for its CY 2017 Physician Fee Schedule and CY 2017 prospective payment systems (PPS) regulations on Hospital Outpatient Services PPS and Home Health PPS.
  • Pursued accurate and clinically-sound local coverage determinations via our persistent advocacy with A/B MAC and DMEMAC medical directors.
  • Built the Alliance’s reputation as a proactive, professional voice on wound care policy through the submission of 21 sets of comments in 2016.
    • 6 to FDA on Homologous Use of HCTPs, Minimal Manipulation of HCTPs, Classification of Antimicrobial Wound Care Products, Use of Real World Evidence.
    • 11 to CMS on Hospital Outpatient PPS, Home Health PPS, MACRA, Physician Fee Schedule, Patient Relationship Classification, Appeals Process, Drug Payment Model, Quality Measurement Plan, MACRA Episode Groups, Contractor Reform, Quality Physician Payment Programs.
    • 3 to CMS contractors on HBOT, CTPs, Pneumatic Compression.
    • 1 to ARHQ on Treatment Strategies for Patients with Lower Extremity Chronic Venous Disease.
  • Expanded and deepened relationships with key CMS and health care reform policy makers via in-person meetings with senior staff at CMS, CMMI and MEDPAC.
  • Educated Alliance members on MACRA, legislative issues and health care fraud investigations and other emerging issues by hosting expert speakers and convening webinars to directly address Alliance-specific questions and concerns.
  • Mobilized Alliance member organizational action on key advocacy issues by keeping members briefed on concerning policies, potential impacts and opportunities to comment. This role of the Alliance as an activation-agent enables member organization to have a greater voice on key issues and enhance their own visibility and advocacy efforts for their memberships.
  • Expanded the strength and reach of the Alliance with 4 new members welcomed in 2016.
  • Increased visibility of Alliance to greater wound care community by speaking at wound care and clinical association meetings and contributing articles on key advocacy issues in wound care publications, websites and blogs (including articles in: OWM, Today’s Wound Clinic, Advances in Skin & Wound Care, Wound Source).

For more information on 2016 activities and accomplishments, as well as information from previous years, click the links below:

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