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Advocacy in Action
1st Quarter 2022
Advocacy Updates In This Issue:

  • Convened meeting with 5 CMS directors across 3 divisions to emphasize the unintended consequences of inconsistent HCPCS coding for CTPs
  • Called for NCCI contractor to fully implement new updates allowing for debridement and compression to be performed on the same day
  • Pressed for greater transparency and uniformity in coverage policy development and implementation of coverage policies in a co-signed letter to CMS 
  • Sought legislative fix to payment cuts impacting non-facility/office-based procedures in letter to Congress with the Clinical Labor Coalition
  • Urged Noridian to fix unclear, inaccurate language in its Wound and Ulcer Care LCD
  • Paved the way for Noridian’s release of stalled claims
  • Welcomed five new members
  • Be in the Know: Updates from the Alliance’s policy tracker
  • THIS WEEK: FDA’s virtual Wound Healing Workshop, April 28-29
  • LAST CHANCE TO REGISTER: The Wound Care Evidence Summit, May 19-20
  • and more...
A Message from Our Co-Chairs:

We are very proud to begin 2022 – our 20th anniversary year! – with a great demonstration of the Alliance’s influence and ability to convene key regulators and policymakers to address issues and collaboratively problem solve with us.

In March, we brought together five directors from three divisions of CMS for a meeting focused on how inconsistent HCPCS code assignments for CTPs and synthetic CTPs have led to problematic issues in both the physician office setting and in hospital outpatient provider-based departments. We highlighted the impact of policies from one division on the policies from another division and illustrated how providers and patients were caught in the policy confusion. Thanks to the help of our hard-working CTP Work Group, we of course also presented detailed recommendations to address issues.

We are pleased to report that CMS directors and their staff were highly engaged, asked clarifying questions, and left the door open for us to come in and lead educational sessions on CTPs. We will be following up on that opportunity over the months ahead, once the Wound Care Evidence Summit (May 19-20 in Bethesda, Md) is behind us.

Speaking of next month's Summit, we are thrilled that so many key influencers in our space will be speaking at this collaborative event. Panelists include payer medical directors (Humana, UnitedHealthcare, Aetna, BlueCross/BlueShield, Medicare), Federal policymakers (FDA, NIH, AHRQ), evidence analysis experts (Hayes, Change Healthcare), leading researchers, medical societies and manufacturers.

If you haven’t registered yet, don’t miss the opportunity to have a seat at this very influential table as we identify shared issues and build clarity around the question: How much and what type of clinical evidence do regulators and payers need to give a positive approval and coverage decision for wound care products & services? 

We at the Alliance are proud to provide this critically important collaboration opportunity to our members, colleagues and peers. We hope you will join usFinally, we’re pleased to report that we welcomed five new members over the past few months (see below) as well as officially opened new membership categories: Hospital Operated Wound Care Clinics, Clinical Wound Care Provider Groups, Wound Care Business Entity Start-Ups, and Professional Service Firms: Associate Membership.

Below is a summary of our many advocacy initiatives this past quarter. Thank you to everyone for your hard work and continuing support. Stay tuned for updates on how we will commemorate and celebrate our 20th anniversary, the organization we've proudly built and the collective success we've achieved. .

Caroline E. Fife MD and Matthew G. Garoufalis DPM;
Co-chairs, Alliance of Wound Care Stakeholders
We emphasized to CMS the unintended consequences of inconsistent HCPCS coding for CTPs (“skin substitutes”)
In March, the Alliance met with 5 CMS directors and their staff across 3 divisions – the Division of Practitioner Services, the Division of Outpatient Care, and Division of Coding and DRG (who have responsibility for the coding and payment of CTPs) – to discuss how the inconsistent HCPCS code assignments for CTPs and synthetic CTPs has led to problematic issues in both the physician office setting and in hospital outpatient provider-based departments. Under new 2022 policies, which included the assignment of “C” codes and/or “A” codes, there is confusion about how to bill services and products - especially in the HOPD. The Alliance presented six specific recommendations supported by a 35-page chart of relevant HCPCS coding history along with HOPPS & Physician Fee Schedule policies to show how they impact each other. We called on the Agency to bring consistency to coding for CTPs and synthetic CTPs and correct the unintended impacts being experienced under current coding policies.
  • Most recently, CMS issued a document in which they placed all CTPs issued an A code into the low-cost bucket (except for Restrata) to reinforce that all CTPs should be treated the same. However, there are still significant issues with the issuance of the A codes and the Alliance will continue to focus advocacy in this area.
We urged NCCI contractor to fully implement recent updates
Following tenacious Alliance advocacy throughout 2021, CMS’ National Correct Coding Initiative (NCCI) contractor updated its policy manual in December to allow for debridement and compression to be provided on the same day. However, they failed to make changes to the accompanying edit tables. Through this quarter, the Alliance has engaged in ongoing discussions with CMS and its contractor, convened a January meeting with senior staff, and submitted letters and a detailed table showing the specific corrections requested in order to have the newly updated language in the edit table be consistent with the Policy Manual.

We pressed for greater transparency and uniformity in development and implementation of coverage issues in co-signed letter to CMS
Led by APMA, the Alliance signed on with more than 18 other organizations to a letter to CMS’ Center for Clinical Standards and Quality addressing issues with LCD/LCA development, CAC issues and the overall lack of transparency and uniformity in stakeholder engagement. Following receipt of the letter, CMS scheduled a meeting to discuss the issues raised. The Alliance collaborated with APMA to help write the letter to include CAC meeting issues that the Alliance had raised in a previous meeting with CMS. Alliance representatives also participated in the February meeting with CMS staff.
We signed on to a Clinical Labor Coalition letter to Congress addressing payment cuts to non-facility/office-based procedures
The Alliance had opposed payment cuts in the CY2022 Physician Fee Schedule by collaborating with the Clinical Labor Coalition in letters and in our own submitted comments. Although several key payment cuts were minimized in the final rule as a result of this advocacy, the Coalition continues to address the range of issues that negatively impact physician practices, including steep Medicare cuts to numerous non-facility/office-based procedures. The Alliance signed on to a new letter from the Coalition aimed to muster additional Congressional support to find a legislative fix.
✓ We urged Noridian to fix incorrect and outdated terminology in its Wound and Ulcer Care LCD 
The Alliance had spent a substantial amount of time in early 2021 developing comprehensive comments to Noridian’s draft Wound and Ulcer Care LCD. When the final LCD issued in October, we flagged concerns. In response, we were instructed by Noridian to submit a Reconsideration Request. However, the Alliance believes that many of our recommended changes (i.e., fixes to incorrect descriptions of CTP codes and outdated language) are “non-substantive,” meaning that they are clarifying updates that do not change the policy itself and, therefore, can be incorporated without going through the reconsideration process. Our most recent communique to Noridian included a detailed chart of these small but important changes to show how the corrections would add accuracy and clarity to the LCD.
✓ We successfully paved the way for Noridian’s release of stalled claims
When the Alliance heard from members about suspensions of claims for amniotic skin substitute products or those with a “Q” code, we reached out to the Noridian medical directors to seek clarity on the rationale for the suspension. As a result of our organized advocacy, in February Noridian published an article on its website providing clarity regarding amniotic and/or placental derived products and reporting that “claims that have been pending will be released in the upcoming days for processing.”
Influential wound care trade publications featured more policy coverage and advocacy updates via a series of by-lined pieces contributed by the Alliance. These recently included:
Attended MedPAC virtual meeting in January; alerted members to agenda items that addressed assessing payment adequacy and updating payments.

Participated on CMS “listening sessions” on transitional coverage for emerging technologies, held Feb. 17 & March 31 to help inform CMS’ development of an alternative coverage pathway to provide transitional coverage for emerging technologies. The Alliance had submitted multiple comments to the Agency when the 2021 Medicare Coverage of Innovative Technologies and Reasonable and Necessary proposed rule was being shaped, when the final rule issued, when it was delayed and when it was subsequently repealed. These recent meetings are, we hope, a step forward to help CMS better achieve the goals of timely and predictable Medicare coverage of devices while ensuring that Medicare covers items and services on the basis of sound clinical evidence and with appropriate safeguards.

Alerted to Noridian educational sessions in March on Negative Pressure Wound Therapy and Pneumatic Compression.

Convened in-person Alliance meeting for the first time since the start of the pandemic, with an April 7 gathering for members and guests timed to the Spring SAWC meeting in Phoenix.
FDA Wound Healing Workshop April 28-29 (virtual)

We've been working closely with the FDA to serve as a resource in planning for its “Wound Healing Scientific Workshop,” which will focus on chronic non-healing wounds. The FDA’s virtual Workshop on April 28-29 will be synergistic with our Alliance Wound Care Evidence Summit.

As part of the workshop, the Agency and wound-healing experts aim to outline the landscape of and review current standards for product development in non-healing chronic wounds, as well as identify challenges to implementing and conducting clinical trials, discuss potential solutions to overcome these challenges, and explore how current research can be applied to promote product development. 

Many Alliance members will speak at the FDA Workshop, including board Co-Chair Dr. Caroline Fife and Executive Director Marcia Nusgart.

Wound Care Evidence Summit
May 19-20

We at the Alliance appreciate that even with progress made at the April FDA Workshop and the Agency’s acceptance of expanded evidence, endpoints and real-world data will have little impact if PAYERS don’t also accept these as a basis for coverage decisions. 

To align thinking across payers AND federal policymakers, researchers, practitioners and manufacturers, the Alliance is convening the Wound Care Evidence Summit – building on topics addressed at the FDA Workshop and layering the perspectives of payers.

Take advantage of this unprecedented opportunity to build shared clarity and construct collaborative solutions to evidence and coverage challenges. See our agenda and impressive speaker list. We urge all members to attend and encourage you to extend an invitation to your professional networks so that we have a diverse range of stakeholders and perspectives around the table.
Registration closes shortly.
Don't go unrepresented in these critical & collaborative conversations.
  • FCSO and Novitas issued in April proposed LCDs on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. The LCDs address the medically reasonable and necessary threshold for coverage of skin replacement surgery for application of skin substitute grafts for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). The reason stated for the draft LCD is “Creation of Uniform LCDs With Other MAC Jurisdiction.” Comments will be accepted until 5/28/2022. 

  • CGS updated in April its local coverage article on “Billing and Coding: Wound Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities” to add Q4253 to Group 2 codes, retroactive to 10/01/2021. 

  • DMEPOS Relief Act of 2022: This draft legislation, introduced in February, would apply a 90/10 blended Medicare reimbursement rate for home medical equipment in former competitive bidding areas. The Alliance’s government affairs workgroup is evaluating the legislation and its impact. 

  • Medicare Claims Processing Manual: To clarify the instructions to contractors, CMS released revisions to the Medicare Claims Processing Manual transmittal and a Medicare National Coverage Determinations Manual on Blood-Derived Products for Chronic, Non-Healing Wounds. (Jan.)

For more information, visit our members-only
Alliance of Wound Care Stakeholders' Policy Tracker.
Welcome to these new business entity members who recently joined the Alliance.
We look forward to working together!

See our full list of current members and our newly expanded membership categories.
Learn more about the value of membership.
Please join us in thanking the sponsors of the upcoming Wound Care Evidence Summit for supporting the Alliance and enabling us to convene this important and unique solution-building opportunity.
The Alliance of Wound Care Stakeholders