Alliance Update: Wound Care Policy News and Comments for Q4 2018 Protection Status
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Alliance Advocacy Prompts Changes to HCPCS Coding Updates

Following years of Alliance of Wound Care Stakeholder (Alliance) advocacy to the Centers for Medicare and Medicaid Services (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 their 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 Nov. 2018 update, CMS unveiled key process updates that reflect recommendations the Alliance has 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 three 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.

Also in November, 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 the Alliance proposed in submitted comments and advocacy meetings. This illustrates the importance of the Alliance’s ongoing, persistent advocacy and the value of a united voice of wound care practitioners to effect change.

While these certainly do not solve all of the issues the Alliance has flagged over the years, CMS has said it will "continue to examine this program area." The Alliance looks forward to continuing their 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 reached proactively out to CMS to request a meeting to discuss their 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. The Alliance convened the meeting with CMS on Feb. 5 to specifically share their recommendations on a proposed episodic payment approach—recommendations they forged via a series of one-on-one discussions, conference calls, a Jan. 10 webinar, and a collaborative group meeting Jan. 25 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.

In addition to work focused on CTP payment, the Alliance also addressed additional CTP coverage issues in 4Q.

  • Noridian policy article. Noridian's November 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. They 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 the Alliance considers clinically inaccurate and that threatened their current landmark CTP standard guide F3163-16 - which took years of advocacy to put in place to accurately define CTP terminology for payer and coverage purposes. Marcia Nusgart attended ASTM's Nov. 8 meeting, and other Alliance members such as Dr. Chuck Drueck and Kathleen Schaum participated via conference call. ASTM members expressed their concerns about this issue and staff was planning to speak with the ASTM chair to address any next steps.

Additional Q4 Submitted Comments:

WPS Coding Companion
Alliance continued its advocacy to WPS following its spring issuance of "Wound Care Coding Companion for Wound Care L37228" - a debridement policy that eliminated coverage. In a Q4 email to WPS, the Alliance requested, again, the literature that WPS reviewed to eliminate coverage of the codes identified. The Alliance offered to submit additional literature for consideration. The Alliance is in the process of reviewing the evidence that they have received from members for potential submission to WPS. Similarly, their colleagues at the American Podiatric Medical Association (APMA) have also weighed in with a reconsideration request to WPS.

"In making this coverage determination, WPS eliminated coverage yet did not provide any of the evidence that WPS reviewed which resulted in this determination. In order to have a more transparent process, the 21st Century Cures Act requires MACs to provide the evidence utilized in making coverage decisions and in eliminating coverage. WPS has not provided that information. While we are happy to provide evidence to support the reinstatement of these codes, we would like to request the evidence reviewed to eliminate coverage."

Key Q4 Meetings & In-Person Advocacy

  • SAWC: The Alliance convened at the November 2018 SAWC meeting in Las Vegas to cover key work plan issues/updates. Attendees gained strategic political and policy insights from guest speaker Dave McNitt of National Health Advisors.
  • RUC Meeting: With several clinical association members, Marcia Nusgart attended the October meeting of the Relative Value Units (RVUs) Update Committee (RUC) in Chicago to monitor and address relevant wound care issues raised.
  • Member conferences:
    • Diabetic Foot Global Conference (DFCon), Oct. 11-13, Houston
    • American College of Wound Healing and Tissue Repair, Oct. 5-6, Chicago (Alliance leadership attended)
    • American Vein and Lymphatic Society (formerly the American College of Phlebology) annual meeting, Nov 8-11, Nashville (Alliance leadership attended)
  • UPCOMING - Spring SAWC: Mark your calendars for the Spring SAWC meeting in San Antonio, Tx on May 7-11. The Alliance will convene an in-person meeting during that time—stay tuned for the date/time!

Recent Publications & Policies Relevant to Alliance

  • Revisions to the LCD process: In October, CMS released revisions to its Medicare Program Integrity Manual as mandated under the 21st Century Cures Act to increase transparency to the LCD process Summarized in a CMS fact sheet and MedLearn Matters, these are the first changes to this process in a very long time. The Alliance has long advocated for process changes to ensure CMS contractors be more transparent in the development of/changes to LCDs and policy articles. CMS set up an email account ( to collect feedback on how the revisions are working.
  • The Alliance was busy developing and submitting comments in Q3 on the multiple CMS CY2019 PPS policies that impact wound care. In Q4, CMS issued final rules and policy updates, including:
    • Physician Fee Schedule Final Rule. The final reflected a number of inputs the Alliance submitted in their comments. See CMS fact sheet on quality and payment provision changes for 2019.
    • ESRD/DMEPOS Final Rule. Additionally, CMS invited comments on potential new product categories for the next round of DMEPOS competitive bidding.
    • Hospital Outpatient PPS Final Rule. The Alliance continues to be in dialogue with CMS on payment methodologies put forward in this rule.
  • New leadership at PDAC Announced: Palmetto GBA won the Medicare's Pricing, Data Analysis and Coding (PDAC) contract. The transition went into effect Jan. 15, 2019. Doran Edwards, M.D., was named the Medical Director for the PDAC. Dr. Paul Hughes, former PDAC Medical Director will remain with Noridian to help on coverage issues.

About the Alliance of Wound Care Stakeholders
The Alliance of Wound Care Stakeholders: The Alliance is a nonprofit multidisciplinary trade association of health care professional and patient organizations 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.

The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.

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