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Dr. Samuel R. Nussbaum, former Chief Medical Officer of Anthem, speaks with Deanna Eaves, Coalition co-chair and Marcia Nusgart before presenting at the Coalition’s 2016 strategic planning meeting; Coalition of Wound Care Manufacturer members at its 2016 strategic planning meeting; Amy Bassano, Director of the Patient Care Models Group in CMS’ Center for Medicare & Medicaid Innovation (CMMI) with Coalition co-chairs Deanna Eaves and Randall Carson and Executive Director Marcia Nusgart at the Coalition’s 2016 meeting; Patient Centered Outcome Research Institute (PCORI) staff Greg Martin at 2015 Coalition meeting; CMS Director Dr. James Rollins at 2015 Coalition meeting.

2016 Coalition Achievements

With the ongoing shifts in the U.S. healthcare landscape under a new Presidential administration, coupled with the uncertain 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 industry perspective is of increasing importance. The Coalition’s work in 2016 focused on voicing the impacts to wound care and the wound care industry on FDA efforts to reclassify antimicrobial wound dressings and of CMS policies, including its CY2017 prospective payment systems, Medicare Administrative Contractors (MAC) contracting process, Part B Drug Payment Model, Competitive Bidding and others. The Coalition identified and took advantage of multiple opportunities for input, advocacy and comment. Our comments put us “on the record,” built credibility across our industry and opened doors for ongoing advocacy and dialogue.

Key Coalition accomplishments and activities in 2016 include:

  • Advocated on issues impacting wound care and wound care manufacturers via 14 submitted comments in 2016.
  • 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 care dressings should be classified as “Class II (with Special Controls),” thus protecting access and availability of antimicrobial wound care dressings for patients and providers.
  • Provided a united wound care industry voice to FDA on guidance documents addressing the Agency’s regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products by voicing collective concerns and recommendations.
  • Encouraged CMS with a unified industry voice to put mechanisms in its Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program to better vet vendors, ensure vendor quality and adequately monitor access to products.
  • Recommended to Pricing, Data Analysis and Coding (PDAC) leadership specific changes and updates that could address coding verification issues, and mobilized contractor to take action.
  • Pointed much needed attention to the recurring flaws in the Medicare Administrative Contractor (MAC), Qualified Independent Contractor and Recovery Audit Contractor medical review processes.
  • Sought great transparency and accountability for MACs and PDAC contractors via submitted comments to CMS’ Medicare Administrative Contractor (MAC) contract awards and incentives guidance.
  • Ensured concerns of wound care manufacturers were articulated to CMS by submitting comments to the Agency’s proposed rules for its CY 2017 Prospective Payment Systems for Hospital Outpatient Services and Home Health.
  • Informed and educated Coalition members on Medicare payment reform, MACRA and key issues and policies impacting wound care by convening and hosting expert speakers.
  • Mobilized Coalition’s members to take company-specific action on key advocacy issues by keeping members briefed on concerning policies, potential impacts and opportunities to comment.
  • Served as an active supporter and participant in Alliance of Wound Care Stakeholders activities to ensure that the wound care provider clinical expert voice is proactively speaking to the impact of policies on patients and providers (See 2016 Alliance accomplishments.)

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

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