Alliance Advocacy Update
In This Issue: Q4 2019
The Alliance’s Inaugural Evidence Summit:
Speakers Announced
We are excited to kick-off 2020 by proactively tackling a critical issue with impact across the wound care community:

What and how much clinical evidence do payers need to cover wound care products and procedures?

At our April Wound Care Evidence Summit in Washington D.C., we will convene payers, policymakers, and regulators to address this question and collaboratively build solutions to common challenges.

SPEAKERS JUST ANNOUNCED! Our experts include:
Payers – Medical Directors:
  • Aetna / US Healthcare’s Dr. Raymond Fabius (retired)
  • Anthem’s Dr. Alan Rosenberg (retired)
  • Humana’s Dr. Charles Stemple
  • Noridian’s Dr. Laurence Clark

Policy makers & regulators:
  • AHRQ’s Dr. Elise Berliner
  • FDA’s Dr. Cynthia Chang
  • NIH’s Dr. Marcel Salive
Evidence Experts & Researchers:
  • Dr. David Armstrong, University of Southern California; Southwestern Academic Limb Salvage Alliance
  • Dr. Joseph Mills, Baylor College of Medicine; Baylor St. Luke's Medical Center Diabetic Foot and Wound Care Center
  • Dr. Vickie Driver, Brown University
  • Dr. Marissa Carter, Strategic Solutions
Alliance Advocacy Results in Significant Revision to
WPS Wound Care LCD
We are thrilled to announce that due to the Alliance and our members’ fierce advocacy and collaborative efforts, WPS re-wrote its wound care final LCD . WPS listened to our testimony and comments to significantly revise what had been an extremely egregious coverage policy regarding debridement coverage and dNPWT utilization parameters. The key issues we flagged were directly addressed – and corrected – in the final wound care LCD:

  • Pressure injury, stage II and diabetic foot ulcers are now included in the list of conditions that must be present to obtain a debridement

  • CPT codes related to debridement of other chronic non-pressure ulcers when the severity is classified as “limited to breakdown of skin” were placed back into the policy.

  • dNPWT utilization parameters that conflicted with the existing DMEMAC policy have now been removed

This late-December policy update from WPS is the long-fought result of our three-year dedicated advocacy initiative . Since initial publication of this policy in 2017, the Alliance has submitted multiple comments and letters of clarifications, testified at two WPS public meetings, and engaged in numerous phone and email correspondences.

Special thanks to the American Podiatric Medical Association, the Alliance member who led the recent LCD reconsideration request that provided the opportunity for this current round of comments. Together, we galvanized the submission of 40+ comments, driving the changes we see today and demonstrating the value of collective, coordinated advocacy on behalf of the wound care community.

While there are still several clinical inaccuracies in the final LCD that we will address, the WPS response to our comments and correction of key issues now ensures that clinicians are able to provide debridement and disposable Negative Pressure Wound Therapy to patients with the appropriate conditions. Most importantly, patients can derive the wound healing benefits these treatments offer. 
Long-Sought HCPCS Reforms Implemented in
 2020 Coding Cycles
Together with the Alliance for HCPCS Coding Reform, we achieved a long-sought HCPCS reform advocacy “win” when CMS unveiled in December a “ comprehensive strategy to foster innovation for transformative medical technologies” that included allowing medical device manufacturers to submit Healthcare Common Procedure Coding System code applications twice a year rather than once a year, and drug and biologics applications four times a year .

These process reforms are important because they can help speed the time in which new wound care products can come to market.

See more updates on Alliance accomplishments in our 2019 annual report, arriving to your inbox in the weeks ahead!
Q4 2019 Submitted Comments
WPS Wound Care LCD
The Alliance took issue with WPS policy’s inclusion of only a limited number of conditions that must be present in order to provide debridement, ignoring current standards of practice. The Alliance submitted comprehensive clinical evidence and clinical practice guidelines. We also voiced concerns at WPS’ October public meetings. Our advocacy led to a huge victory for patients and providers - with significant revisions in the final LCD that directly addressed the concerns we raised ( see article above ).

Letter to Congress on “Cures 2.0”
The lead authors of the 21 st Century Cures Act, Rep. Diana DeGette (D-CO) and Rep. Fred Upton (R-MI), solicited input from stakeholders on modernizing how new medical products are covered by public and private health insurance (an initiative dubbed “Cures 2.0”). The Alliance submitted a December letter focused on contractor coverage issues, transparency issues, and the importance of real-world evidence. Development of “Cures 2.0” will be a long process and our comments put us on the record early, opening the door for continued conversations and advocacy as legislation moves forward.

USP Medicare Model Guidelines
The Alliance submitted comments in October to the United States Pharmacopeia's (USP) draft Medicare Model Guidelines. Our comments supported the creation of a new subcategory for wound care products. This would help to distinguish the chronic wound products from other subcategories, which would better protect coverage of wound care products under Medicare Part D.
Key Q4 2019 Meetings
  • SAWC Fall: Alliance executive director Marcia Nusgart, together with APMA’s Dr. Jeff Lehrman, presented a session titled “How to keep on top of government regulations that might impact the treatment of your wound care patients.Overlapping with the meeting, Alliance members convened in-person for a work session focused on developing consensus comments to address the WPS draft LCD on wound care.

  • Diabetic Foot Global Conference (DFCon): Marcia Nusgart, on a panel in the role of “Regulatory Hurdler,” shared perspectives at the session “Toe-ward A More Perfect Union: The State of Diabetic Foot Research in 2019.”

  • Health Care Payment and Learning Action Network: Alliance staff and members participated in the Fall Summit featuring speakers from CMS, CMMI, Anthem, Humana, PCORI, National Quality Forum and more. 
Welcome to New Members!
Welcome to our newest business entity member: Healogics .