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Advocacy and Policy
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Alliance of Wound Care Stakeholders

In addition to the efforts taken on by the Society, we have also enjoyed success through our membership in the Alliance of Wound Care Stakeholders (The Alliance). The Alliance is a nonprofit, multidisciplinary, trade association of physician medical specialty societies and clinical associations whose mission is to promote quality care and access to products and services for people with wounds through effective advocacy and educational outreach in the regulatory, legislative and public arenas. Through the Alliance, the Society is able to comment and follow government regulations on multiple fronts and directly impact policy decisions. Recent updates include:

Alliance Advocacy Prompts Changes to HCPCS Coding Updates

Following years of proactive Alliance advocacy to CMS flagging concerns that the Healthcare Common Procedure Coding System (HCPCS) coding process chilled innovation and created barriers to coverage and reimbursement for DMEPOS and other new technologies/products in the wound care space, the Alliance of Wound Care Stakeholders is pleased to report that improvements to the process will be put in place in 2019. The Alliance is a founder and key member of the Alliance for HCPCS Coding Reform who has met regularly with CMS and HHS staff to articulate our concerns with the process.

CMS "heard from stakeholders regarding the public HCPCS application process. CMS is interested in adopting changes to the HCPCS process that facilitate the adoption of new technologies while balancing the burden on payers and providers," the Agency stated.  In a November 2018 update, CMS unveiled key process updates that reflect recommendations we've provided.  Under these new processes, CMS will:

  1. Clarify and update website guidance associated with the application process to promote transparency.

  2. Advance a new electronic application process.

  3. Eliminate the 3 percent (of market) volume criteria as a coding criteria for non-drug items.

  4. Provide more detailed responses to applications in order to provide for greater transparency.

  5. Enable more remote participation in HCPCS Public Meetings.

  6. Increase transparency by including an archive of past years' files/decisions on the HCPCS website, providing a research archive for potential applicants and stakeholders.

In November 2018, CMS released its 2019 HCPCS coding decisions and is now making important new information available such as product name, the preliminary coding decision, final coding decision and rationale.

Many of these updates stem from the specific recommendations we proposed in submitted comments and advocacy meetings.

This illustrates the importance of our ongoing, persistent advocacy and the value of a united voice of wound care practitioners to effect change.

While these certainly do not solve all the issues we have flagged over the years, CMS has said it will "continue to examine this program area." We look forward to continuing our conversations in 2019 on additional reforms to ensure access to quality care, improve coverage and reimbursement policies, and benefit wound care patients and the practitioners who treat them. 

Paving a Payment & Coverage Path for CTPs in 2019 and Beyond

While the Alliance prides itself on representing and advocating for a broad range of wound care specialties, products and interventions, much of the latter part of 2018 - and the early party of 2019 - has been dominated by coverage and payment issues impacting cellular and tissue- based products for skin wounds (CTPs).

On the payment front, the Alliance proactively reached out to CMS to request a meeting to discuss our positions on payment of CTPs in the hospital outpatient setting (HOPPS) in order to influence the Agency's position on this issue as it begins to write the CY 2020 HOPPS proposed rule. We convened the meeting with CMS on February 5, 2019 to specifically share our recommendations on a proposed episodic payment approach - recommendations we forged via a series of one-on-one discussions, conference calls, a webinar (January 10, 2019), and a collaborative group meeting (attended by WOCN Society representative and current President-Elect, Stephanie Yates) on January 25, 2019, to build consensus and prioritize recommendations. CMS was engaged and receptive and valued the Alliance as a resource to be called upon as the Agency has further questions as they write the proposed rule.

Challenged Noridian Policy Article

Noridian's November 2018 policy article, "Use of Amniotic Membrane Derived Skin Substitutes", limited coverage of CTPs to only treating VLU and DFU, stating "we have not received any evidence-based, peer reviewed clinical literature published in the core medical journals to support any other use." The Alliance mobilized members to gather and submit data. We submitted a letter to address legal concerns as well as offering to educate Noridian on CTPs. Noridian's medical director responded quickly and in-person conversations are now being scheduled.

Protected ASTM Standard

The Alliance mobilized individual members who use, or manufacture, CTPs to vote negative on a recently-proposed ASTM ballot addressing a newly proposed standard that we consider clinically inaccurate and that threatened our current landmark CTP standard guide F3163-16. This guide took years of advocacy to put in place to accurately define CTP terminology for payer and coverage purposes. Marcia Nusgart attended ASTM's November 8, 2018 meeting, and other Alliance members such as Dr. Chuck Drueck and Kathleen Schaum participated via conference call.


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