Changing Policy Through Advocacy: 20 Years of Elevating the Voice of Wound Care Provider

The upcoming new year marks the 20th anniversary of the Alliance of Wound Care Stakeholders’ founding. Its mission is to stand as the unified voice of wound care and protect access to products and services for people with wounds and the clinicians who treat them. Through its advocacy and education campaigns, the Alliance works tenaciously to influence and improve policies from the Centers for Medicare and Medicaid Services (CMS), the U.S. Food and Drug Administration, and other regulatory agencies that affect the delivery of wound care.

You may have played a role in the Alliance’s advocacy through one or more of the associations to which you belong. More than 20 clinical associations are members of the Alliance, including the Association for the Advancement of Wound Care, American Podiatric Medical Association, American Professional Wound Care Association, Wound Healing Society, and Wound, Ostomy and Continence Nurses Society. Together, we have elevated the wound care voice and influenced policy on a broad range of coding, coverage, and payment issues. Our work has protected access to—and reimbursement for—wound treatments and services spanning antimicrobial wound dressings, cellular- and tissue-based products for wounds (eg, skin substitutes), compression, debridement, hyperbaric oxygen therapy, negative pressure wound therapy (NPWT), surgical dressings, and more.

How has this affected everyday practice? The following are several recent examples of the real-world impact Alliance advocacy has had.

IMPACTS

Disposable NPWT (dNPWT) national payment rate.

Real-world impact. Outpatient clinics have fair reimbursement for dNPWT.

Advocacy initiative. The Alliance saw years of advocacy work come to fruition when the CMS finally increased reimbursement from $100 to $208 for dNPWT in the physician’s office in the 2020 CMS physician fee schedule.¹ As the CMS was determining the reimbursement rate, the Alliance flagged concerns with the supply price that was being referenced and urged the CMS to rely on objective third-party data sources or actual invoices showing prices paid by physicians for dNPWT devices for office-based care. The reimbursement was raised significantly because of Alliance members’ submission of actual invoices.

Surgical dressings coverage.

Real-world impact. Clinicians have a broader choice in surgical dressings for Medicare patients for primary and now secondary purposes.

Advocacy initiative. Alginate and fiber gelling dressings previously could only be billed under Medicare as primary dressings. This limited health care providers’ discretion and choices in properly treating patients with wounds. The Alliance convened multiple calls with Medicare Administrative Contractors’ medical directors, assembled clinical evidence, and educated CMS staffers. The result was that the CMS released an updated policy article in October 2020² that expanded coverage of alginate and fiber gelling dressings for both primary and secondary purposes.

Debridement coverage.

Real-world impact. Clinicians are not restricted from performing debridement on patients with stage 2 pressure injuries and diabetic foot ulcers.

Advocacy initiative. When the Wisconsin Physicians Insurance Corporation, a Medicare administrative contractor, released a local coverage determination that dangerously limited the coverage of debridement in the 6 states it covers, the Alliance worked to remove restrictions. For example, the policy included stage 2 pressure injuries and diabetic foot ulcers on the list of conditions that must be present to perform debridement. The Alliance spearheaded a multiyear advocacy campaign that ultimately resulted in the Wisconsin Physicians Insurance Corporation significantly revising its local coverage determination to one that now allows patients with these types of wounds to receive the procedures they need.³

COVID-19 leadership.

Real-world impact. Many wound clinics stayed open to treat patients during the public health emergency due to COVID-19 because of Alliance efforts.  Regulatory relief and flexibilities were enacted during the rapidly evolving emergency to address some of the on-the-ground realities of wound care amid the pandemic.

Advocacy initiative. Within hours of the March 2020 shutdowns and stoppage of elective health services, the Alliance established a rapid-response team that launched an advocacy initiative to ensure that wound care was identified as essential. A cornerstone of that campaign was the position statement, Wound Care is an Essential–Not Elective– Service that Prevents Hospital Admissions and ED Visits Among a Fragile Cohort of Patients at High-Risk of COVID-19.⁴ Many hospital administrators were able to keep wound clinics open as a result of Alliance advocacy. The Alliance then pursued regulatory flexibilities to enable clinicians to provide wound care in a variety of settings. This work allowed select wound care services to be provided via telehealth and having a patient’s home be considered an extension of the hospital for billing and reimbursement purposes.

Value-based payment for wound care providers.

Real-world impact. Wound care clinicians have more relevant options for quality reporting, which in turn enables payments under the new Medicare value-based care payment structure.

Advocacy initiative. As the CMS moves from fee-for-service reimbursement to value-based care, the Alliance has been instrumental in voicing the concerns of wound care providers to be fairly recognized and appropriately paid. In 2017, the CMS began a new method for determining Medicare payment to health professionals that requires, among other things, the reporting of quality data for a score to be developed for payment.⁵ It was concerning that none of the obligatory quality, resource use, and clinical performance reporting measures in the 2 quality payment program reimbursement pathways—the Merit-Based Incentive Payment System and Alternative Payment Models—were specific to wound care. While nearly every medical specialty launched qualified clinical data registries to facilitate participation in the former and develop quality measures relevant to practice, wound care clinicians were at a disadvantage because wound management is not a recognized specialty. After much advocacy, the CMS agreed that the Alliance could act in lieu of a specialty society, given its role as a convener of all the clinical associations relevant to wound management. Together with the U.S. Wound Registry, the Alliance had developed a series of quality measures relevant to wound care⁶ that were then recognized by the CMS as a qualified clinical data registry, an important step forward. As quality payment programs evolve, the Alliance will continue to advocate for not only wound care–relevant quality measures that reflect and reward the real-world care that wound care clinicians provide, but also care measures and chronic care models to drive better health outcomes and smarter spending in the wound care space.

A LOOK AHEAD AT 2022: REAL-WORLD EVIDENCE AND PAYER COVERAGE

Real-world evidence, and the relationship between wound care evidence and payer coverage, will take center stage in 2022 as the Alliance undertakes a major initiative to proactively combat the increasing number of restrictions in payer coverage policies that create barriers to patient and provider access to wound care treatments and services. The Alliance believes that many of today’s coverage restrictions stem from a lack of transparency and shared clarity about the type and quantity of clinical evidence necessary for commercial and government payers to provide favorable coverage decisions for devices and procedures.

In May 2022, the Alliance will convene payers, policymakers, researchers, clinicians, and manufacturers at its inaugural Wound Care Evidence Summit. This meeting will address challenges and build a collaborative understanding regarding how clinical evidence and clinical guidelines are considered in coverage decisions. It will also address how real-world evidence might be considered moving forward. The time is right for a multidisciplinary look at state-of-the-art research and the reimbursement landscape because both directly affect patient access and health outcomes.

NEW OPPORTUNITIES FOR REAL-WORLD EVIDENCE

The Alliance has long advocated for the acceptance and inclusion of real-world evidence in wound care policies. Currently, Medicare contractors request randomized controlled trials (RCTs) for coverage of products. However, in the wound care space, RCTs cannot truly evaluate the effectiveness of wound care products in the real-world setting. That is because patients with chronic wounds tend to have serious comorbid conditions, and these conditions commonly eliminate these patients from participating in RCTs. As a result, RCT populations do not reflect patients who require wound care. Methods of evaluation that include real-world data are much more valuable in assessing wound care products and interventions, but regulators and payers do not yet accept them.

In late 2021, the U.S. Food and Drug Administration issued 2 promising new draft guidance documents on real-world evidence that opened the door for acceptance of registries, electronic health records, and medical claims data to support regulatory decision-making. In the year ahead, the Alliance will focus on supporting these policies, clarifying their application to wound care, and working to open the doors to broader acceptance of real-world evidence in the wound care space.

The Alliance will also seek support of real-world evidence on Capitol Hill as part of evolving legislation referred to as Cures 2.0,⁷ which builds on the 21st Century Cures Act passed in 2015.⁸ Although the original legislation sought to improve how new drugs and treatments were researched and developed in the United States, Cures 2.0 aims to improve the delivery of those new treatments and therapies to patients. Early drafts of the legislation include specific provisions to expand the use of real-world evidence. The Alliance has weighed in with letters to Congress and will continue to provide the wound care perspective on Cures 2.0 provisions such as those addressing real-world evidence.

As it has been doing for the past two decades, the Alliance will continue to serve as a vocal, visible, and effective advocate on a broad range of wound care issues. As we embark on our 20th year, we have created new member categories to invite more wound care stakeholders to the table. Learn more and keep up with Alliance advocacy, track relevant policies, review submitted comments, and read more about the Evidence Summit at www.woundcarestakeholders.org.

REFERENCES

1. Department of Health and Human Services. 42 CFR Parts 403, 409, 410, 411, 414,415, 416, 418, 424, 425, 489, and 498. Federal Register. November 15, 2019. Vol. 84. No. 221. https://www.federalregister.gov/documents/2019/11/15/2019-24086/medicare-program-cy-2020-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other. Accessed November 16, 2021.

2. Centers for Medicare & Medicaid Services. Surgical Dressings-Policy Article. A54563. https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=54563&ver=38&KeyWord=SURGICAL+DRESSING&KeyWordLookUp=Title&KeyWordSearchType=Exact&bc=CAAAAAAAAAAA. Accessed November 16, 2021.

3. Centers for Medicare & Medicaid Services. Wound Care. L37228. https://tinyurl.com/yjzjwc9h. Accessed November 16, 2021.

4. Alliance of Wound Care Stakeholders. Wound Care is an Essential–Not Elective–Service that Prevents Hospital Admissions and ED Visits Among a Fragile Cohort of Patients at High-Risk of COVID-19. https://www.woundcarestakeholders.org/images/Final2_Statement_-_Wound_Care_as_Essential.pdf. Accessed November 16, 2021.

5. Centers for Medicare & Medicaid Services. Quality Payment Program. https://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program Accessed November 17, 2021.

6. U.S. Wound Registry, U.S. Podiatry Registry. Quality Measures: Provided by the US Wound & Podiatry Registries, Developed With Clinical Associations Wound Care Quality Measures. https://uswoundregistry.com/quality-measures/Accessed November 16, 2021.

7. Cures 2.0, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes. 117th Cong (2021). https://degette.house.gov/sites/degette.house.gov/files/CURES%202.0%20Text.pdf. Accessed November 18, 2021.

8. 21st Century Cures Act, HR 6, 114th Cong (2015). https://www.congress.gov/bill/114th-congress/house-bill/6. Accessed November 17, 2021.

Ms Nusgart is the Executive Director of the Alliance of Wound Care Stakeholders. The Alliance of Wound Care Stakeholders is a nonprofit multidisciplinary trade association of physician specialty societies, clinical and patient associations whose mission is to promote evidence-based quality care and access to products and services for people with chronic wounds through advocacy and educational outreach in the regulatory, legislative, and public arenas. Contact: marcia@woundcarestakeholders.org. The opinions and statements expressed herein are specific to the respective author and not necessarily those of Wound Management & Prevention or HMP Global. This article was not subject to the Wound Management & Prevention peer-review process.