Legislative Update: Alliance of Wound Care Stakeholders

 

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.

 

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.  

 

 

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. 

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.