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

Recent Publications of Interest

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 our key areas of focus in Q3 2016.  Please share this update within your specialty society, association or organization. 

We look forward to seeing many of you on Friday, Oct. 7 at our in-person meeting at the SAWC conference in Las Vegas.
  FDA September Meetings Put Wound Care Front and Center;
Alliance Mobilizes Expert Voices to Address Wound Dressing Classification & CTP Regulation 

The Alliance of Wound Care Stakeholders played a key role in educating the FDA and its advisory panel on the role and real-world value of antimicrobial wound care dressings, as the FDA considered a regulatory classification of these products that could impact access and availability to wound care providers and patients.
FDA Panel Recommends Class II for Antimicrobial Wound Dressings
On Sept. 20-21, the FDA convened its General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee regarding the classification of devices that are wound dressings combined with drugs. These products currently are classified under the "FRO" product code category and include but are not limited to: solid wound dressings, gels, creams, ointments, and liquid wound washes. FDA held the meeting to obtain input on the risks and benefits of wound dressings combined with drugs (antimicrobial wound dressings), and asked the panel for recommendations whether such wound dressings should be classified into Class III (subject to Premarket Approval), Class II (subject to General and Special Controls), or Class I (subject only to General Controls).
Though commonly used across a multitude of wound care applications, many antimicrobial wound dressings pre-date the FDA's classification system, so are currently unclassified. However, as FDA undertakes formal classification of these products, their designation could have a significant impact on the accessibility of these products by clinicians, the speed of bringing new wound dressing products to market, and the price of such products if they are determined by FDA to be Class III. As such, heading into the meeting, the Alliance took an active role in protecting access to this important category of wound care products by educating FDA and its advisory panel that the products in this FRO category are low to moderate risk, have been proven in the marketplace for many years, don't play a meaningful role in antibiotic resistance, and should be classified by the FDA into either Class I or Class II, most remaining subject to 510(k).
The Alliance took a 3-prong advocacy approach to educate FDA and its panel: (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 (in progress, due Oct. 20), and (3) mobilization of a team of expert speakers to testify at the open public hearing portion of the meeting to proactively address issues that the panel needed to consider to make a well-informed decision. In addition to testimony from Alliance executive director Marcia Nusgart, speakers mobilized by the Alliance included:
  • Dot Weir, on the management of chronic wounds
  • Dr. Gregory Schultz, on the biology of wound healing
  • Dr. Caroline Fife, on the value of wound care registries and registry data
  • Dr. Marissa Carter, on trial design and endpoints
  • Dr. Randall Wolcott, on clinical aspects of antimicrobial agents and antimicrobial resistance
  • Dr. Susan Alpert, on classifying medical devices
  • Dr. Eric Lullove, representing the Association for the Advancement of Wound Care
  • Judy O'Grady, providing industry perspective from Integra LifeSciences
  • Angela Bunn, providing industry perspective from Mölnlycke Healthcare
  • Karen Ravitz, representing industry input from the Coalition of Wound Care Manufacturers
In its concluding votes, the advisory panel ultimately concurred with the Alliance's position, recommending to the FDA that antimicrobial wound dressings should be classified as a Class II with special controls. While the Agency is not obligated to follow the recommendations of its advisory committees, it does tend to.
The Alliance will be hosting a working session at the SAWC meeting in Las Vegas next week to debrief on this meeting and collect inputs for formal written comment submission. Contact Marcia Nusgart if you'd like to attend.
Alliance Weighs In as FDA Collects Input on the Regulation of HCTPs
Also in September, the FDA held a public hearing to obtain input on its four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps). While much of the public testimony from the 100+ registered speakers focused on issues related to the more controversial area of stem cell therapies, the implications of these guidance documents for wound care were addressed by the Alliance as well as by the Coalition of Wound Care Manufacturers and other stakeholder groups. HCT/Ps are of particular benefit to chronic non-healing wounds as they help provide an environment for the patient's own cells to rebuild tissues, provide a protective barrier and wound cover, and decrease the risk of bacterial contamination.
The draft FDA guidance documents have potential to help provide clarity regarding pathways forward for the development of additional innovative HCTPs, and promote the safe use of these products. However, the Alliance focused its  testimony and written comments on specific areas of the "minimal manipulation" and "homologous use" guidances that need additional clarity to make them clinically meaningful, clinically accurate, and consistent with - rather than contradictory to - existing regulations.
 "There are many significant new requirements within the minimal manipulation document which not only conflict with the homologous use document, they conflict with current regulatory language," the Alliance - represented by Dr. Paul Kim - informed the FDA in oral testimony, highlighting a number of specific examples: (1) the term "main function" introduced in the minimal manipulation document conflicts with the current definition of homologous use, and (2) the change regarding how minimal manipulation is determined - specifically the focus on the "main function" of the tissue in the donor rather than what is written in current law: by the function of the tissue in the recipient.
The Alliance and other commenters emphasized that the draft guidances in fact make material changes to current regulatory language, so should be subject to the notice-and-comment rule making process. It is unclear at this time whether the FDA will issue a proposed rule as a next step, or simply take some of the recommendations provided to them and revise the draft guidance documents. We'll track the issue and keep you informed.
Submitted Comments:  Ensuring Alliance's Clinical Expert Perspective is Heard

Alliance advocacy continued at a frenetic pace throughout Q3 with the submission of 10 comments to key stakeholders to protect patient and provider access to wound care procedures and technologies:

Comments to CMS:

Patient Relationship Categories 
The Alliance submitted comments in early August to the proposed rule regarding patient relationship categories.  This proposal was issued as part of CMS efforts to create mechanisms to ensure that the costs of care allocated to a physician are truly those over which the physician can influence utilization. The Alliance provided several clinical vignettes for CMS to understand the complexities of treating a wound patients, demonstrating how wound care patients tend to bounce between settings, between acute and non acute episodes and are treated in a multi-disciplinary approach.

Comment Call-Outs:

"The way in which CMS has crafted resource use measures has the perverse effect for wound care physicians of measuring resource use in one group of patients while the physician reports quality measures in an entirely separate group of patients....As long as cost and quality are entirely unrelated to each other in the area of wound care, the goals of MACRA cannot be achieved."
CY 2017 Hospital Outpatient Prospective Payment System
The Alliance continued to focus attention on the concerning issue that no measures in the Hospital Outpatient Quality Reporting program are specific to wound care. The Alliance reminded CMS in submitted comments that there are 21 quality measures specific to the practice of wound care, fully programmed as electronic clinical quality measures available within the U.S. Wound Registry Qualified Clinical Data Registry. Furthermore the Alliance focused comments on the flawed methodology CMS uses to calculate payment for CTPs.  

"The Alliance continues to maintain that it is the responsibility of CMS to ensure that these products are coded and billed appropriately so that the APC Group assignments are assigned correctly.  The Alliance submits that these products are not being coded and billed correctly: the claims data are inaccurate and the APC Group assignments are negatively impacted. It is the responsibility of CMS to ensure that hospitals are not only reporting the correct CPT application code, but also that the number of units applied align with the number of units reported with the CPT code."  

CY 2017 Home Health Prospective Payment System 
The Alliance focused its comments on the implementation of the newly created statutory benefit to pay home health agencies separately for disposable Negative Pressure Wound Therapy. 

"Our recommendation is that in addition to paying for the disposable NPWT device, CMS also pay the home health agency the nursing time and travel for initial and subsequent visits to those patients requiring home health services who can benefit for the use of disposable NPWT...We do not believe home health agencies should absorb the cost of that care."   

CY 2017 Physicians Fee Schedule
The Alliance commented on a range of issues, noting erroneous calculations and flawed methodology in the hyperbaric oxygen therapy section, objecting to CMS's proposals to eliminate the 10 and 90-day global surgical periods, and advocating for more appropriate valuation of electrical stimulation and ultrasound therapy.

"Many Alliance members provide HBOT to treat their patients. As such, the Alliance respectfully requests that CMS review the methodology used to determine the total oxygen consumption during a hyperbaric treatment, and accept the RUC recommendation."

Changes to the Medicare Appeals Procedures
The Alliance's August comments focused on the backlog of CMS contractor appeal decisions.

"The Alliance recommends that any proposed remedies to the Medicare appeals backlog include evaluation of Contractor appeal decisions...Erroneous contractor decisions clog the appeals systems and expend unnecessary resources for all stakeholders including CMS and providers." 
Co mments to A/B MACs:

Noridian: LCD for Hyperbaric Oxygen (HBO) Therapy 
In August comments, the Alliance expressed concern about inconsistent and incorrect information in the draft policy. 

"There are several areas in the draft policy in which Noridian provides specific dose and frequency parameters which are contrary to current standards of practice. Some of the evidence used is outdated, contradicts existing evidence and is not relied upon by those physicians that perform HBOT for the treatment of covered HBOT indications. We recommend that Noridian revisit this draft LCD and clear up inconsistencies, confusing language, inaccurate information, and outdated evidence." 

Cigna Government Services: LCD for Application of Skin Substitute for Wounds of Lower Extremities
T he Alliance reminded CGS in comments that the term "skin substitutes" is clinically inaccurate and should be replaced with more inclusive descriptor "Cellular and/or tissue based products for wounds (CTPs)." The Alliance also expressed concern that CGS would not be providing coverage for the service or the product when they are applied by a podiatrist or other clinicians when their state practice act permits this procedure to be done. 
"The Alliance urges CGS to recognize podiatrists as providers who can and do treat patients with wounds - especially diabetic foot ulcers, as well as any other qualified health care professional in which this service is permitted to be performed within their state practice act."

Comments to FDA Draft Guidance:

Minimal Manipulation and Homologous Use of CTPs
Following oral testimony at FDA's September public hearing seeking input on its proposed guidances to regulate CTPs (see lead story above), the Alliance submitted formal written comments to FDA's Minimal Manipulation and Homologous Use draft guidances for industry and FDA staff.  

Comments to AHRQ:

Technology assessment: 
As a member of the Venous Care Partnership, the Alliance helped develop comments to ARHQ's technology assessment "Treatment Strategies for Patients with Lower Extremity Chronic Venous Disease." 

Key Q3 Meetings & In-Person Advocacy

Alliance meetings with stakeholders this quarter addressed the following issues: 

World Union of Wound Healing Societies (WUWHS) Congress: the Alliance participated in the presentation " Current State of Wound Care in Europe and the U.S.-Clinicians and Manufacturers Challenges of Balancing Good Clinical Practice with Government Policy Changes" on Sept. 25. 


American Podiatric Medical Association: Alliance staff attended the APMA annual meeting in Philadelphia in July and updated its public policy committee on the activities of the Alliance.


Upcoming meetings: We look forward to seeing many of you on Fri., Oct. 7 at our in-person meeting at SAWC! Also, mark your calendars for the Health Care Payment Learning and Action Network's Oct. 25 meeting in Washington DC. The HCPLAN focuses on payment reform and accelerating the transition already underway by aligning stakeholders across sectors. Registration is free. The Alliance is a "committed partner" to LAN initiatives.


R ecent Publications & Policies Relevant to Alliance
Webinar Replay
Alliance Webinar on "Health Care Fraud Investigations: What to Do When the Government Knocks" - Available to Listen to Now!
  • The Alliance recently teamed up with speakers from Epstein Becker and Green for a complimentary webinar addressing the risks and risk management tools for wound care practitioners and manufacturers related to federal and state health care fraud enforcement under the federal False Claims Acts, including its "whistleblower" provisions. We had an excellent response from our members. If you had a schedule conflict and were not able to participate you can click here to access the webinar when it is convenient for you.
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.