A quarterly newsletter from the Alliance of Wound Care Stakeholders  
In This Issue:

Recent Publications of Interest

Mark your calendars for our in-person Alliance meeting at the Spring SAWC conference 
April 5-9 in San Diego.

Welcome to Alliance Advocacy Update, the  Alliance of Wound Care Stakeholders' quarterly update on our ongoing advocacy initiatives on behalf of our clinical association members to ensure access, coverage and payment to wound care procedures and technologies for patients and providers. 

Below is an update on some of our key areas of focus this past quarter (Q4: Oct.-Dec.), as well as a summary of our 2016 accomplishments.  Please share this update within your specialty society, association or company. 
  Celebrating the Strength of our Collective, Collaborative Voice: 2016 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 the wound care perspective is of paramount 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. Over the past year we identified and took advantage of multiple opportunities for input, advocacy and comment. We worked tireless to ensure that regulatory agencies are aware of the issues and impacts to wound care as policies are 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 issue 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 top accomplishments in 2016 include:
  • We elevated visibility of wound care issues to CMS as it refined regulations guiding implementation of the Medicare Access and CHIP Reauthorization Act (MACRA), ensuring that the agency and its policy-makers heard and 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. Our comments put specific wound care issues "on the record" and set the stage for future advocacy activities.  We will continue to advocate for inclusion of specific wound care quality measures for wound care clinicians to be able to utilize and submit moving forward.
  • We demonstrated to CMS the clinical and economic expenditure impact of chronic wounds to the Medicare program by commissioning health consultants Dobson DaVanzo & Associates to perform an analysis of Medicare claims and payments. The data illustrated that expenditures for treating Medicare wound care patients are larger than recognized, result in a severe clinical burden, impair quality of life for Medicare beneficiaries and are most likely underreported.  The Alliance submitted findings directly to CMS via our MACRA comments, and we are now seeking publication of the data in a respected medical journal.
  • We played a key role in effectively educating the FDA and its advisory panel on real-world use and value of antimicrobial wound care dressings, resulting in the panel's recommendation to the FDA that antimicrobial wound dressings should be classified as a Class II with special controls.  We educated our members on the concerning impact to access/availability/price that a change in classification could mean, and implemented a four pronged approach that included (1) submission of comments in advance of the meeting to provide relevant background information on wound care complexities, (2) submission of post-meeting follow-up comment, (3) mobilization of a team of expert speakers to testify at the open public hearing portion of the meeting and (4) provided Alliance testimony during the panel meeting.
  • We ensured that wound care concerns were articulated and flagged to CMS as it set payment rates and policies via its CY 2017 prospective payment systems (PPS) regulations by submitting written comments on the provisions that impacted wound care within the Hospital Outpatient Services PPS and Home Health PPS, as well as submitted comments to the CY2017 physician fee schedule.
  • We pursued accurate and clinically sound local coverage determinations with our persistent advocacy with A/B MAC and DMEMAC medical directors for fair and equitable LCDs and coverage processes. Advocacy in 2016 focused on LCDs addressing hyperbaric oxygen therapy and cellular and tissue-based products (CTPs) for wounds.
Overall, we built the Alliance's reputation as a proactive, professional voice on wound care policy through the submission of a total of 21  sets of written and oral comments to regulatory agencies and contractors on diverse topics in 2016, including:
  • 6 to FDA,
  • 11 to CMS,
  • 3 to CMS contractors
  • 1 to ARHQ
The breadth and depth of these comments builds the Alliance's reputation as the wound care association that responds quickly and addresses wide range of wound care issues.
We're pleased that we welcomed 4 new members this year: American Diabetes Association┬« Foot Care Interest Group; the Wound, Ostomy and Continence Nurses Society (WOCN); and the National Lymphedema Network (NLN); American Board of Wound Management Foundation. We look forward to continuing to expand our strength and reach. 

Finally, we're proud of the added value that we've provided by convening thought leaders throughout the year to provide insights and info specific to Alliance member needs.  We hosted experts around payment reform (Dr. Paul Radensky and Dr. Sam Nussbaum), legislation (Dave McNitt) and enforcement actions (webinar with Epstein Becker Green). We will continue to provide educational opportunities to members throughout the year ahead.  
A more detailed look at our collective Alliance accomplishments is here

W e have much work ahead of us in 2017 and look forward to continued collaboration and success.
Submitted Comments:  Ensuring Alliance's Clinical Expert Perspective is Heard

Alliance comments to regulatory agencies in Q4 included:

Comments to CMS: 
MACRA Final Rule 
The Alliance responded to CMS's Final Rule on Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) with comments highlighting our two most pressing and important concern: that it fails to encourage the use of qualified clinical data registries (QCDRs) as part of quality measurement and reporting. Also focusing on the rule's quality performance categories. The Alliance advocated that quality development should be "patient centric," or at the very least, problem centric rather than setting-based. "In other words, the measures should follow the patient and not the site of care if patient-centered care is going to exist," we advocated.
Comment Call-Outs:

" We do not think that the Agency fully understands the negative impact that the final rule will have on QCDRs, or in the way in which QCDRs could work to alleviate the burden of MIPS implementation on eligible professionals if given the freedom to do so...We request CMS reconsider the use of QCDRs and allow the quality measures to be used as part of the MIPS quality score and for MIPS quality bonus points."

Comments to FDA: 
"Real-World Evidence" Draft Guidance
The Alliance submitted comments   to FDA draft guidance on "Use of Real World Evidence to Support Regulatory Decision-making for Medical Devices" and voiced its support for the use of data from registries, claims, and electronic health records to support the evaluation of medical devices. Comments noted to FDA the limitations of randomized clinical trials to evaluate the effectiveness of a wound care product or intervention and provided specific examples of how registry data could be used in assessing the safety of a wound care medical device.

"Approximately 75% of real world patients would have been excluded from every major wound healing RCT that brought new products to market over that decade at the "first pass" before study related laboratories or tests would have been performed. RCTs are not able to evaluate the effectiveness of a wound care product or intervention, when more than half of patients are excluded from participation, greatly diminishing the applicability of RCT results to real world populations and evidence based medicine." 

Comments to FDA: 
Classification of Antimicrobial Wound Care Products
The Alliance continued its leadership role in educating the FDA on the role and real-world value of antimicrobial wound dressings. Following FDA's Sept. 20-21 advisory committee meeting, we led the charge in asking for an extension to the comment period so that stakeholders could have sufficient time to respond to the specific issues raised at the meeting.  At the request of Alliance members and others, the comment period was extended from October to November. At that time, the Alliance, and many of our members, submitted comments supporting the FDA panel's recommendation that antimicrobial wound dressings should be classified as a Class II with special controls.  We focused on issues discussed at the meeting that either needed to be emphasized due to their importance, or that needed some additional clarity and context. 

Thanks to all who mobilized around this classification issue with comments and testimony!

"The products containing antimicrobial agents, but not antibiotics, that have been regulated in the FRO category have a long history of use in contributing to the care of chronic wounds... The Alliance believes the panel's recommendation to classify these products into Class II is appropriate and the FDA should move to propose this classification with special controls including the development of a guidance document and class labeling."

Key Q4 Meetings & In-Person Advocacy

Alliance Q4 meetings with stakeholders included: 
Health Care Payment Learning and Action Network: The Alliance attended HCPLAN's Oct. 25 meeting in Washington DC and held  in-person meetings with senior staff at CMS and the Center for Medicare & Medicaid Innovation  (CMMI), including Sean Cavanaugh , Amy Bassano, Matthew Price and Kate Goodrich.  The Alliance is now a "committed partner" to the HCPLAN initiatives, which is focused on payment reform and accelerating the transition already underway by aligning s takeholders across sectors.
MEDPAC: Marcia Nusgart and Karen Ravitz, along with Alliance BOD members Dr. Caroline Fife and Jule Crider met with Medicare Payment Advisory Commission executive director Mark Miller and staff to brief the Commission on our recent data findings on the prevalence and spending for wounds in the Medicare population, our concerns related to current quality measures being put in place, and the value of the U.S. Wound Registry and the role it could play in quality measures.
Alliance in-person meeting at SAWC: The Alliance gathered Oct. 7 as part of the SAWC meeting in Las Vegas. We reviewed our work plan, accomplishments and current advocacy issues; heard from Dr. Greg Bonn, Dr. Caroline Fife and Kara Couch on NPUAP terminology change issues; and we featured guest speakers Dr. Sam Nussbaum on "MACRA and the Path to Alternative Payment Models" and Dave McNitt on "Legislative Initiatives Impacting Wound Care." The Alliance also hosted a de-brief for members who were involved in the FDA meetings and comments surrounding the classification of antimicrobial wound products.

for our next in-person Alliance meeting on April 7 at the upcoming SAWC conference in San Diego. 
Q4 Publications & Policies Relevant to Alliance
  • CMS placed information on its website in 4Q on the 2017 new HCPCS codes - the applications submitted, preliminary coding decisions and final coding decisions.
  • The final rules published in 4Q for CY2017 Hospital Outpatient and Home Health prospective payment systems, as well as for the Physician Fee Schedule
  • CMS released in 4Q the MACRA final rule on its quality payment program, and posted a series of educational pieces for clinicians.
  • PDAC released a correct coding article for pneumatic compression devices: which ones should be used for various clinical conditions. The original article "Correct Coding for Pneumatic Compression Devices" was published in August 2010. This end-of-2016 revision provides additional information regarding the HCPCS coding requirements for these items.
Feb. 2017 Publication Update: Wound Care LCDs
  • New: First Coast and Novitas both recently released draft LCDs on wound care. The Alliance circulated copies to membership. We are reviewing the LCDs and will be reaching out to Alliance membership to prepare comments.  For the Novitas LCD, the comment period is until March 9, 2017 and the Jan. 26 public meeting was attended by the Alliance.  The deadline for comments to the First Coast LCD is also March 9 and the public meeting is Feb 16 in Jacksonville, FL. The Alliance is in the process of developing comments and will be reaching out to collect inputs.
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The Alliance of Wound Care Stakeholders is an association of physician and clinical organizations focused on promoting quality care and access to procedures and technologies for patients with wounds through advocacy and educational outreach in the regulatory, legislative and public arenas. The Alliance unites leading wound care experts to advocate on public policy issues that may create barriers to patients' access to treatments or care, with a focus on reimbursement, wound care research and wound care quality measures.