Over the past year, the Alliance of Wound Care Stakeholders once again proved that the unified voice of the wound care community has power. In 2022, we successfully persuaded the CMS to remove problematic provisions in the proposed CY2023 Physicians Fee Schedule that would have created significant barriers to advanced wound care treatments. We joined voices with aligned stakeholders to engage members of Congress on legislation directly impacting wound care, ultimately resulting in the Better Wound Care at Home Act and the Lymphedema Treatment Act being enacted into law in the final days of the year. Together, we tenaciously advocated for improved access to wound care products and services, and that advocacy continues in 2023.
Below is a summary of key policy issues impacting wound care today and the current initiatives of the Alliance-which unites clinical associations and medical specialty societies representing the broad array of healthcare providers who treat wounds-to provide a collective advocacy voice to regulators and legislators as policies are shaped.
TACKLING LEGISLATIVE POLICY ISSUES THAT DIRECTLY IMPACT PATIENT CARE
To understand some of the legislative policy issues in play now, we first have to look back. In 2022, advocacy to members of Congress and Congressional committees played a critical role in ensuring that two wound care legislative policy priorities-the Better Wound Care at Home Act and the Lymphedema Treatment Act-were included in the Consolidated Appropriations Act 2023 that President Biden signed into law on December 29, 2022. Considering the small size of the wound care industry compared to other healthcare sectors, this was an important win for the wound care community to get two provisions included and, most importantly, an important win for wound care patients.
The Lymphedema Treatment Act requires Medicare to pay for compression garments, bandages, and supplies to reduce lymphedema-related swelling and prevent recurrence. Because lymphedema is known to delay wound healing, this will facilitate wound healing and prevent recurrent infections. Similarly, the Better Wound Care at Home Act removes a number of bureaucratic barriers, making it easier for home health agencies to provide disposable negative pressure wound therapy to the patients they serve.
Although this was a win, the devil is in the details, as the expression goes: in this case, the implementation and operationalization details that will be put in place by the CMS. The CMS is now in the process of developing regulations to implement the coding, coverage, and payment mandated by this legislation, and the Alliance has been focused on educating policymakers about specific issues that should be addressed. For example, we convened meetings with CMS staffers to ensure they are well-informed about the broad range of compression garments and their associated fitting and application needs as coding, coverage and payment issues are considered and set. We also highlighted the need for additional Current Procedural Terminology* procedure codes for medical and allied health providers to account for the time and expertise required. A proposed rule from CMS is expected in mid-2023.
PROTECTING PATIENT ACCESS TO CELLULAR AND/OR TISSUE-BASED PRODUCTS IN THE PHYSICIAN'S OFFICE
In mid-2022, CMS proposed seismic changes to how cellular and/or tissue-based products for skin wounds (CTPs, also known as skin substitutes) would be coded and paid for in the physician's office setting. In the draft 2023 Physician Fee Schedule, the Agency proposed reclassifying all CTPs as "supplies incident to a physician service" and bundling payment into practice expenses-a change that could negatively impact patient access.
The Alliance kicked into gear with advocacy focused on the implications on patient access, emphasizing that payments for CTPs and their application would simply not cover the costs to physician offices under that proposed policy. Without adequate reimbursement, many physicians could not absorb the cost of purchasing CTPs to provide to patients. The resulting lack of patient access to these advanced wound care treatments could then result in an increase in infections as well as amputations. The Alliance and its members urged CMS to delay implementation of the proposed CTP provisions until patient access issues can be further studied and vetted.
The wound care community's voice was heard and acted on! Following tenacious advocacy, the provisions were removed from the final 2023 Fee Schedule. Further, CMS convened a "Skin Substitute Town Hall" meeting in January 2023 to solicit additional public input as it considers ways to move forward with a consistent payment approach for CTPs across different sites of service. This issue is very much still in play as CMS prepares its proposed CY2024 Fee Schedule, expected to publish over summer 2023.
The Alliance not only remains in dialogue with CMS on this matter but has also engaged directly with members of Congress. We met with staffers from the House Ways & Means Health Subcommittee and the Senate Finance committee to elevate concerns about CMS policy proposals to bundle CTPs in the physician office setting and the impact that could have to patient access and outcomes. Most recently, we submitted a statement to the House Appropriations Subcommittee on Labor, Health and Human Services, Education & Related Agencies asking for legislative language protecting average sales price pricing for CTPs to be included in the upcoming CMS Program Management Account appropriations bill. Dialogue and proactive advocacy continue.
PROTECTING PROVIDER PAYMENT
Over 2022 and into 2023 the Alliance has co-signed multiple letters to Congress with the Clinical Labor Coalition and the Conversion Factor Coalition voicing concerns about continued, significant year-over-year cuts in physicians' Medicare reimbursements and clinical labor payments. These letters articulate and escalate concerns that declining Medicare payments and ongoing cuts not only impact patient access to care, but also undermine the long-term financial viability of physician practices. The Alliance, together with 100+ aligned clinical associations and medical specialty societies representing more than one million healthcare providers, have urged Congress to tackle substantive Medicare payment reforms to sustain America's medical practices and medical practitioners.
DRIVING CLINICALLY ACCURATE, EVIDENCE-BASED COVERAGE POLICIES
Decisions about which wound care products and services are (or are not) covered under Medicare are made either at the national level or by regional Medicare Administrative Contractors that each make local coverage determinations (LCD) for the parts of the country they cover. The impact of these policies is significant. If something is not covered, one cannot get reimbursed for it. As a result, many clinical treatment decisions must be guided by Medicare coverage decisions, which are not always consistent with best clinical practices.
The Alliance monitors LCDs and focuses advocacy on correcting clinical inaccuracies and provisions in LCDs that are unsubstantiated by evidence and/or that may negatively impact patient access. In 2022, the Alliance aggressively pursued revision of a particularly egregious "Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers" LCD from three different Medicare administrative contractors that contained restrictive and arbitrary utilization parameters that would negatively impact patient care. These revised LCDs are expected to issue this year. Advocacy continues.
MAKE WOUND CARE BETTER: MAKE YOUR VOICE HEARD IN 2023
Advocacy has impact, both short-term and long-term. Much like 2022, 2023 has shaped up to be a year of challenge, change, and opportunity. Beyond the issues above, CMS has released a proposal to improve Medicare Prior Authorization Processes and correct some long-standing issues surrounding Medicare Advantage. The Food & Drug Administration convened a "Wound Healing Workshop" in Spring 2022 that we hope may soon open doors to future FDA guidance expanding the use of real-world data and evidence in wound care clinical trials. Health equity issues are being elevated across government agencies.
Policymakers are particularly interested in the voices of healthcare providers. Individual clinicians, clinical associations, specialty societies, wound clinics, and health systems all have valuable perspectives to share. We encourage our clinician colleagues to take advantage of opportunities to share real-world experiences by adding your voice and submitting letters and comments. Articulating the realities and complexities of wound care helps policymakers and payers forge better-informed policies, and that makes wound care better.