Wound Clinics and Wound Care Advocacy: Advocating for Evidence-Based Coverage and Reimbursement

Payer coverage and payment regulations dictate which products and services wound clinics and wound care clinicians can provide to their patients. Yet, the decision-making process is often unclear: Who develops the policies? Why are they too often out of sync with best practices? In addition, how can providers be effective advocates on policy issues?

The Alliance of Wound Care Stakeholders focuses on these questions. Representing more than 20 clinical associations, physician specialty societies, and patient organizations, the Alliance leads advocacy initiatives that are concentrated on Center for Medicare and Medicaid Services (CMS), Medicare Administrative Contractors (MACs), and Food and Drug Administration (FDA) policies that impact coding, coverage, and payment. The Alliance promotes policies that best support evidence-based quality care and access to products and services for people with chronic wounds.

By the time a clinician experiences the impact of a policy (e.g., a product is not covered for a patient), it’s too late to “fix” the process. In most cases, provisions were buried in the fine print of a multi-page proposed policy, which busy clinicians do not have time to read, much less try to change. Of course, so many decisions are driven by formularies that are often based on such policies. This is why unified advocacy on behalf of the wound care community is important—not only to identify the specific provisions impacting wound care but to proactively educate regulators early on, when policies are still in development.  

How Does Advocacy Directly Impact Wound Care Practice?

Advocacy addressing coding, coverage, and payment has real-world impact on patient care. Here are examples of recent Alliance initiatives:

Regulatory flexibilities. Throughout 2020, much advocacy was focused on policies, regulatory waivers, and flexibilities put into place during the COVID-19 public health emergency. The Alliance organized a campaign to ensure that wound care was understood as “essential,” providing support to wound care providers as they sought to keep clinics open. The Alliance advocated for regulatory flexibilities to remove barriers so that wound care could be provided efficiently, effectively, and safely across a range of sites of service with appropriate reimbursement. For example, the Alliance pursued reimbursement for wound care–related telehealth visits and flexibility in documentation requirements; it also launched an online COVID-19 action center to keep practitioners aware of new policies and flexibilities. Going forward, the Alliance will advocate to keep those flexibilities and other changes that its members recommend continuing after the pandemic.

Surgical dressings. CMS’ Durable Medical Equipment Medicare Administrative Contractors (DMEMACs) recently updated its surgical dressings coverage policy to include coverage for secondary and primary use of alginate and other fiber gelling dressings. DMEMACs are the Medicare contractors that process durable medical equipment claims and create the coverage policies that can have a huge impact on access to and use of wound care products. Prior to this policy update, these dressings could only be billed under Medicare as primary dressings, limiting providers’ discretion and choice. This update was a direct result of the Alliance’s advocacy, which included educating the DMEMAC medical directors about how these types of dressings are used, assembling clinical evidence and submitting policy language for consideration. The end result: the updated surgical dressing local coverage article (A54563) that allows expanded indications and greater access to fiber gelling dressings.

Debridement. When CMS contractor Wisconsin Physicians Services (WPS) released a local coverage determination (LCD) that specifically identified a limited number of conditions that must be present in order to provide a debridement, it left out a significant number of conditions that require it. The Alliance jumped into action: submitted comments, testimony at public meetings, calls with WPS leadership and more. The Alliance spearheaded a multiyear campaign that ultimately resulted in WPS reversing course and significantly revising its LCD to one that is more clinically accurate and that now will allow patients to get the procedures they medically need. For example, stage II pressure injury and diabetic foot ulcers are now included in the revised list of conditions that must be present to obtain a debridement.

Payment for CTPs. Medicare may be proposing to change the way that cellular and/or tissue-based products for skin wounds (CTPs, formerly called “skin substitutes”) are reimbursed in the hospital-based outpatient department. Over the past several years, CMS has placed the issue in its annual Hospital Outpatient Prospective Payment System (HOPPs) rules, collecting feedback on Episodic Payment, Single Ambulatory Payment Classification (APC) and Comprehensive APC approaches. Each year the Alliance has submitted detailed feedback and flagged specific issues for the Agency to reconsider. This spring, as CMS began development of proposed rules for CY 2022, the Alliance again proactively submitted recommendations and met with CMS to review concerns. The CY 2022 HOPPs policy is expected to issue shortly, and any proposed CTP payment changes are likely to affect clinicians by next year.

PRP for wounds. In January 2021 comments, the Alliance recommended several changes to CMS’ National Coverage Decision for Autologous Blood-Derived Products for Chronic Non-Healing Wounds. The Alliance supported CMS' decision to provide Medicare coverage for the use of autologous platelet-rich plasma (PRP) for patients with chronic non-healing wounds, it 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.” In the final regulation, that restriction was removed, enabling coverage. The Medicare Administrative Contractor has also released for comment a new proposed LCD draft coverage decision for these products and scheduled a public meeting to solicit feedback.

Clarifying coverage. When Medicare Administrative Contractor Noridian issued a draft wound care LCD this February, the Alliance mobilized to provide feedback to refine the policy. For example, the Alliance flagged that the terms “wound,” “ulcer,” “skin ulceration,” “ulcerated skin” and “skin ulcer” were used interchangeable throughout the policy but, in fact, have very different clinical meanings and definitions. This confusion created a lack of clarity about coverage. Similarly, the policy’s definition of “advanced wound dressings” was inaccurate and incomplete, which could result in important categories of dressings being uncovered and unaddressed. When finalized in the months ahead, this LCD will apply to the 13 states that Noridian covers, and, importantly, is likely to serve as a reference for other MACs across the country as they update their own policies.

Playing the Long Game of Advocacy

Advocacy to policymakers and regulators is a long game. Not all advocacy has immediate results. Educating policy makers and influencing policy change can take years of weighing in, submitting comments, and voicing the needs of the wound care provider and patient community. Many advocacy “wins” are incremental, not always exactly what is asked for but a step in the right direction. Even recommendations that are not ultimately reflected in final policies are important as they put the wound care perspective “on the record,” opening doors for ongoing advocacy and dialogue.

The Important Role of Clinicians in Advocacy

The Alliance unifies the collective voice of wound care providers. Its membership includes physician specialty societies clinical and patient associations spanning the Association for the Advancement of Wound Care; American College of Hyperbaric Medicine; American Podiatric Medical Association; Amputee Coalition; American Venous Forum; Wound Healing Society; Wound, Ostomy, and Continence Nurses Society and many more. As a unified umbrella organization, the Alliance leverages the collective power of its members to ensure that wound care has a strong voice and a seat at the regulatory table when policies are being developed and decisions that impact wound care are made.

Many clinicians are under the impression that the manufacturers carry the most influence with policy makers but in fact that is not the case. Individual clinicians and those who work at wound clinics play an important advocacy role. Policymakers at the CMS and FDA are particularly interested in the voice of healthcare providers and patients. With real-world experience, expertise and credibility, individual clinicians and clinics can convey the nuances of their discipline so policymakers can make well-informed coding, coverage, and payment decisions. Clinicians can effectively explain why a product or treatment is clinically important and the negative impact on patients when lack of coverage denies access to needed care.

Your opinion does matter! The challenge with advocacy is getting those opinions in front of the right policymakers, in the right way, at the right time, proactively and repeatedly. That is what the Alliance tackles every day.

Over the year ahead, the Alliance is focusing not only on restrictive coverage policies that deny or limit patients—and their providers—access to important products/services/procedures, but also on the core issue that appears to drive such restrictions: a lack of shared clarity surrounding wound care evidence. The Alliance will be convening payers, policy experts, regulators, researchers and clinicians on May 19–20, 2022 at the “Evidence Summit” that will focus on building clarity around how much and what type of clinical evidence payers need to give a positive coverage decision for products and procedures.

To learn more about how you can get involved in advocacy, reach out to your reimbursement specialists and/or other experts within your wound care clinic who can brief you on the specific  reimbursement challenges in your state. Follow policy issues and comments submitted, both of which are available to members on the Alliance’s website. Take advantage of comment opportunities. Speak up when policies are out of sync with best practices or clinical evidence. You can, ultimately, help improve patient care through policy change.

Learn more about the Alliance here.

Marcia Nusgart, RPh, is the Executive Director of the Alliance of Wound Care Stakeholders.

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