Alliance of Wound Care Stakeholders: Wound Care Advocacy and Policy Updates Protection Status
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By Industry News

In this update:

  • Providing Expert Input to Noridian Draft Wound Care LCD
  • Enhancing Transparency & Predictability of HCPCS Process
  • Supporting Global Malnutrition Composite Score for Quality Measure Endorsement
  • Shaping Hospital Outpatient CTP Payment Methodology
  • Clarifying the Role of Commercial Policies in CMS Decisions About Coverage of Innovative Technology
  • Launching New Members-Only Website Portal (Have You Set Up Your Login Yet?).
  • And more…

Board Perspectives

A Message from the Alliance of Wound Care Stakeholders Co-Chairs
We are thrilled that, like us, so many of our patients are getting vaccinated against COVID-19. Soon, we hope, the pandemic will no longer be a significant barrier to providing in-person services.

We are extraordinarily thankful to our busy members who joined us this winter and spring in call after call, working through revision after revision, as we created comments to Noridian’s draft wound care LCD/LCA. Marcia Nusgart and Karen Ravitz led a tireless effort to gather the vast expertise only the Alliance can from the leaders who literally wrote the books on wound treatment: from clinicians at the frontlines to leading researchers to the manufacturers and innovators of the whole gamut of products and services needed to best treat our patients. Together, we have been tenacious, combing through every detail, finding and correcting inaccuracies, and requesting clarifications. We are hopeful that our comments will be included in the final LCD.

In this update are the details of this quarter’s work. We crafted and submitted several public comments to help shape CMS policy, re-convened the CTP work group, and we are seeing the impact of our educational efforts. So far, the new Administration’s regulatory review process has only had a minor impact on our efforts as CMS pushed back its decision making and comment periods. We will update membership as changes occur. And, keep your eyes on our website as we will be announcing the dates, agenda and speakers for our 2022 Wound Care Evidence Summit.

We are happy to begin the new year by welcoming several new members: National Pressure Injury Advisory Panel, Acera Surgical, Kerecis and Sanara MedTech.

One last note, please make sure that you have created your member account on the Alliance website. Much of the important content – such as our policy tracker and the full text of our comments – is now “members only.” If you haven't already, we suggest that you set up your login (see instructions below) as soon as possible.

Caroline E. Fife MD and Matthew G. Garoufalis DPM; Co-chairs
Alliance of Wound Care Stakeholders

Advocating Leadership: Influencing Policy

The Alliance shaped wound care coverage policies via comments to Noridian.
When Noridian issued a draft wound care LCD in February, the Alliance quickly mobilized to provide feedback and recommendations to refine the final policy. Ensuring that this draft policy was correct clinically is important to Alliance members as it could be used by other AB MACs in the future. The policy as initially issued was well-rounded and, we are happy to report, reflected some of the feedback the Alliance has previously provided to Noridian (for example, recognition of the importance of biofilm in wound healing). However, the policy also included areas with inaccurate information, outdated terminology, and inconsistent language. The Alliance convened a workgroup to bring together the vascular, diabetic foot, pressure and venous stasis ulcer, and biofilm expertise of Alliance membership to develop extensive comments to the draft LCD and its accompanying policy article (LCA). The Alliance also testified at Noridian’s February 24 public meeting. We are pleased that Noridian has the stated focus of making the LCD comprehensive, and we will continue our conversations with the MAC as it works to finalize the policy. Read Alliance comments.

The Alliance recommended hospital outpatient CTP payment methodology reforms
Over the past four years, CMS has placed the issue of reforming the hospital outpatient CTP payment methodology in the OPPS proposed/final rules. In March, as CMS began development of proposed rules for CY 2022, the Alliance convened its CTP working group to create recommendations for CTP payment methodology that were then submitted to the Agency. The Alliance then convened an April meeting with the Agency to discuss recommendations and answer questions. CTPs will remain a key focus area of the Alliance and the CTP working group is addressing Medicare coding, payment, and coverage issues as well as those related to FDA guidance documents. Read Alliance letter to CMS.

The Alliance advocated for enhanced transparency in the HCPCS process
As part of the Alliance's ongoing advocacy to make the HCPCS coding process more transparent, understandable and predictable, the Alliance submitted comments to “CMS' Medicare CY 2021 Durable Medical Equipment, Prosthetics, Orthotics and Supplies Policy Issues and Healthcare Common Procedure Coding System Level II Proposed Rule” focused on code cycles, application re-submissions and other key areas to increase the speed of new products receiving codes so that patients have access to the latest products more quickly. Read Alliance comments to CMS.

The Alliance promoted expanded use of PRP in wounds
In its January comments, the Alliance recommended several changes to the National Coverage Decision for Autologous Blood-Derived Products for Chronic Non-Healing Wounds. While the Alliance supported CMS' decision to provide Medicare coverage for the use of autologous platelet-rich plasma (PRP, a blood-derived product prepared from the patient’s own blood to be used as a wound covering) for patients with chronic non-healing wounds, the Alliance recommended that CMS remove the policy provision stating that PRP would not be covered when used for the treatment of “chronic, non-healing, cutaneous wounds.” Read Alliance letter to CMS.

The Alliance supported global malnutrition composite score inclusion
In support of colleagues at the Academy of Nutrition and Dietetics (“Academy”), the Alliance supported the Malnutrition Quality Improvement Initiative by submitting comments to the National Quality Forum (NQF) in favor of including the Global Malnutrition Composite Score (MUC20-0032) in the Hospital Inpatient Quality Reporting program. This would improve patient care outcomes through standardized identification and treatment of malnutrition. The Alliance will continue to work with the Academy to advance its support through the NQF process. Read Alliance comments to NQF.

The Alliance worked to clarify the role of commercial policies in CMS decisions about Medicare Coverage of Innovative Technology (MCIT)
In January, CMS released its final rule on Medicare Coverage of Innovative Technology (MCIT), which reflected many of the comments the Alliance submitted last year that raised concerns about the lack of transparency in commercial coverage policies. The final rule outlines specific circumstances when CMS can consider commercial coverage policies impacting Medicare coverage, including “if there is insufficient evidence regarding appropriateness for National or Local Coverage Determinations, CMS can look to commercial insurer policies to see how they have addressed coverage.” The policy also stipulates that if Medicare coverage is different from the majority of commercial insurers, CMS will include its reasoning for different coverage in its determinations.

Update: In mid-March under the Biden Administration’s regulatory review policy, CMS issued an interim final rule and delayed the effective date of the final rule for 60 days (to May 15, 2021) to allow a new comment period, with specific questions posed to stakeholders. The Alliance developed comments to CMS on the questions posed.

The Alliance expanded policymakers’ understanding of wound care
The Government Accountability Office (GAO) released two reports this quarter: “Medicare Severe Wound Care: Spending Declines May Reflect Site of Care Changes” and “Medicare Part B: Payments and Use for Selected New, High-Cost Drugs.” As you may recall, GAO staff had come to the Alliance several times to gain insights into a selection of specific wound care issues as they developed these reports. The results of the Alliance's educational efforts with GAO staff are reflected.

Advocacy Leadership: Meetings, Speaking Engagements and Alliance Visibility

American College of Wound Healing and Tissue Repair: Alliance Executive Director, Marcia Nusgart, and Alliance Board Co-Chair, Dr. Caroline Fife, presented an ACTWTR Live! session on wound care advocacy.

HMP/Wound Care Learning Network: Marcia Nusgart and Karen Ravitz joined Dr. Paul Kim on a panel addressing the Impact of COVID-19 on Reimbursement and Governmental Policies.

Wound Management and Prevention published two articles bylined by Marcia Nusgart in January and February issues: Alliance of Wound Care Stakeholders’ Year in Review and Advocating for the Wound Care Community.

UHMS' Pressure: The Alliance’s 2020 achievements were highlighted in an article in Undersea & Hyperbaric Medical Society’s quarterly newsletter, Pressure (p.10).

WoundCon: The Alliance’s accomplishments and activities were highlighted at our virtual booth at WoundCon Spring 2021.

Be Up To Speed: Recent Policy Updates Relevant to Wound Care

  • The FDA Center for Biologics Evaluation and Research (CBER) posted the CBER 2021-2025 Strategic Plan. One of their priorities is facilitating compliance with human cells, tissues, and cellular and tissue-based product regulations: “building on the regulations governing human cells, tissues, and cellular and tissue-based products (HCT/Ps) and key provisions in the 21st Century Cures Act.” CBER’s proposed new work plan and its potential impacts will be a topic to be addressed on Alliance calls over the months ahead.
  • MedPAC released its March 2021 Report to the Congress. Of particular interest: the chapter focused on telehealth in Medicare after the coronavirus public health emergency.

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