Alliance Advocacy Update: Caring About Wound Care

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. The quarterly newsletter includes: current action items for our members, updates on our key areas of focus for this past quarter (Q3: July – Sept. 2015), and future issues we are tracking that are of importance to the wound care community. Please feel free to share this update within your specialty society, clinical association or company.

In this issue:

1. Alliance Call to Action: Draft LCDs addressing CTPs, Pneumatic Compression 
   • Submit Comments on Palmetto’s Draft CTP LCD by Nov. 27
   • Submit comments now on problematic DMEMAC pneumatic compression LCD before it goes into effect Dec. 1
2. News to note: Welcoming new members AANP & VNAA, draft FDA guidance on homologous use, draft debridement LCD, final Medicare Physician Fee Schedule/HOPPS
3. Submitted Comments: Ensuring our Expert Perspective is Heard
4. Key Meetings: Building Relationships with In-Person Advocacy

LCDs addressing CTPs, Pneumatic Compression:

Alliance Call to Action

When fall arrives, many of us send our kids back to school, plan a fall foliage road trip or work on setting the upcoming year’s plans and budgets.  In our Alliance world, we have been tackling issues on two fronts: cellular and/or tissue based products for wounds (CTPs) and pneumatic compression devices. Both issues are highlighted via new draft Medicare local coverage determinations (LCDs) that merit our collective concern, attention and comment.

CTP LCD: Engage CMS via Comments, Proactive Education 

In September, just when we were boarding planes to head to the SAWC meeting in Las Vegas, Medicare Administrative Contractor Palmetto GBA issued a new draft Local Coverage Determination (LCD) on the Application of Skin Substitutes – a draft policy that is very different from the previous draft policy we had reviewed and commented on back in July.  This new draft is a restrictive prescriptive policy that covers only 11 CTP products, eliminates access to CTPs for clinicians to use on their Medicare patients, and contains a rather limited outdated bibliography.  Alarmingly, the LCD also mistakenly classifies most CTP products as wound dressings, entirely missing the distinction and unique benefits of CTPs.

The Alliance’s advocacy action quickly kicked in to gear. The Alliance’s Marcia Nusgart and Karen Ravitz spoke at two out of the four open public meetings focused on this LCD and alerted our members to attend and speak at the meetings held in Virginia, West Virginia, North Carolina and South Carolina. 

The Alliance is now in the process of submitting formal written comments. We ask for not only your inputs and perspective as we draft Alliance comments for submission, but also encourage individual member organizations to develop and submit your own set of comments on this issue. Deadline for comments submission is Nov. 27.

With the mis-characterization of products, glaring clinical inaccuracies and an incomplete biography of sources, it is clear the Alliance is again taking a leadership role on this issue beyond comment submission. As such, we are working with the Palmetto medical directors to provide them with the following initiatives to ensure the wound care provider voice is heard:

1. Drafting of a “model” CTP LCD to submit to Palmetto: Together with our colleagues, the Coalition of Wound Care Manufacturers, we will develop a “model” CTP LCD to submit to Palmetto. The medical director has expressed openness to receiving and reviewing a model document from both the clinical and manufacturer communities. We will be convening calls and asking for input over the weeks ahead.
2. Educational in-service: We have offered to assemble a team of clinical experts to convene an educational session for the Palmetto medical team in order to help them gain a better understanding of clinical decision making surrounding the application of CTPs. This would be structured similarly to the one we presented to CMS staff in 2012 on this issue. We will be reaching out for speakers if/when we are able to get a date for this program.
3. Published study submission/bibliography: After we expressed our frustration with the incomplete bibliography that accompanied the LCD, Palmetto medical staff invited the Alliance and Coalition to submit a comprehensive list of studies for their review and potential inclusion. The Alliance will collaborate in the development of a more robust bibliography of supportive studies. We request our members to submit hard copies of the relevant studies.  

We will be reaching out for member review and inputs over the weeks ahead, so stay tuned. This not the only topic that has our collective feathers ruffled….

Pneumatic Compression Devices Call to Action: Make Your Voice Heard NOW Before Policy is Implemented in December

Last year, the Alliance was successful in having the Durable Medical Equipment Medicare Administrative Contractors (DMEMACs) delay the implementation of a very problematic pneumatic compression LCD issued last year. Unfortunately, the DMEMACs released recently a new LCD on pneumatic compression devices which is equally as problematic on a legal, procedural and clinical basis. While there are some updates we had advocated for - such as now finally enabling podiatrists to prescribe - the final policy is still very restrictive and merits Alliance member attention in terms of follow-up comments, letters and meetings.

This LCD goes into effect on Dec. 1st unless action is taken, and we encourage members to leverage your communication channels with CMS and DMEMACs. As example, the Alliance has been proactive with the following activities:

• The Alliance has sent letters to both CMS’ senior leadership and the DMEMACs to address our legal, procedural and clinical concerns. Our goal is to have this LCD withdrawn. CMS responded quickly and will be convening a meeting with the Agency's senior leadership on Nov. 16. 
• The Alliance also has met directly with one of the DMEMAC medical directors to discuss our concerns with the policy.

Our work is cut out for us. We’ll continue to rely on the perspectives and expertise of membership as we draft additional comments and engage with CMS on this issue. We encourage member organizations to complement the Alliance work with additional submission of comments representing your own unique clinical perspective. We thank you in advance for your inputs and involvement. 

Alliance News to Note

• Please join us in welcoming two new Alliance clinical association members: American  Association of Nurse Practitioners (AANP) and Visiting Nurses Association of America (VNAA).
• CMS has recently issued its final 2016 Medicare Physician Fee Schedule and final 2016 Medicare Hospital Outpatient/ Ambulatory Surgical Center Payment Systems rules. A more detailed summary of the implications of these rules to wound care will be forthcoming.
• National Government Services issued a draft LCD addressing debridement services in October. The comment period extends until Dec. 12. Review the draft policy here.
• On Oct. 29, the FDA issued a draft guidance “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products.”  The agency will be convening a public meeting  on this and related draft guidance on April 13, 2016. The comment period extends through April 29, 2016. 

Q3 Activities & Accomplishments (July-Sept.)