Remove Patient Access Barriers by Correcting Inadequacies in CTP Payments in the 2023 Hospital OPPS Proposed Rule

The Alliance of Wound Care Stakeholders recently urged the Centers for Medicare and Medicaid Services (CMS) to update inadequate payment methodologies for cellular and/or tissue-based products for skin wounds (CTPs, or “skin substitutes”) to ensure appropriate access to care in the hospital outpatient/provider-based department (PBD) site of service.
 
In comments submitted to CMS’s proposed FY 2023 Hospital Outpatient Prospective Payment System (OPPS) updates, the Alliance forwarded specific recommendations to correct policy and payment challenges that are negatively impacting access to CTPs in provider-based departments.
 
“Currently, provider-based departments are not adequately paid for the CTP products for larger wounds,” the Alliance wrote in comments to CMS. “PBDs cannot nor should they incur prohibitive costs and financial losses if they provide CTPs to patients with larger medically necessary wounds or ulcers. As a result, many Medicare patients with larger wounds are not able to receive CTP treatment in the PBD setting. With the policy fixes recommended by the Alliance, PBDs would be fairly paid for the CTPs purchased to apply to all wound sizes and locations, and clinicians will be able to treat all of their wound care patients with the most appropriate treatment, independent of wound size.”

What the Alliance Urges CMS to Do

Enable provider-based departments to be reimbursed for an adequate amount of CTP products for larger wounds. To do this, the Alliance advised CMS to make the following policy change: assign the existing CPT add-on codes (15272 and 15276; 15274 and 15278) to an appropriate ambulatory payment classification (APC) group allowing for payment and issue an exception for the payment of CTP add-on codes.
 
Why this matters to wound care: Currently, the OPPS packages CTPs into the base application code. The add-on codes that are packaged into the bundled rates are not adequate to allow the PBDs to purchase the sizes of CTPs necessary to apply to all wound sizes, forcing PBDs to absorb the cost of additional CTP product themselves to treat larger wound. As a result, many cannot offer CTPs for larger wounds (between 26 and 99 sq. cm and over 100 sq. cm), creating an access issue. Medicare patients with large wound are often now being treated in either the operating room (defined as same day surgery in which the “two-midnight” rule would apply for packaging) or they are referred and treated with CTPs in physician offices. However, physician offices are also now also facing a concerning reduction in CTP payments under the proposed 2023 Physician Fee Schedule, which will further exacerbate patient access to these advanced wound therapies.
 
Equalize payment for the application of CTPs on wounds/ulcers of the same size. The Alliance recommended that CMS assign APCs for the same size wound regardless of anatomical location.
 
Why this matters to wound care: CMS currently has assigned the application of CTPs applied to 100 sq. cm or greater wounds on the feet to a lower paying APC group than the same size wounds/ulcers on the legs. As a result, PBDs receive unequal amount of reimbursement when treating wounds of the same size in different parts of the body. This has been problematic in PBDs since the identical amount of CTP product must be purchased regardless of the anatomic location of the wound. With this policy change, all anatomic locations of the same size wound be paid equally because they require the same amount of product to be purchased and inequities in payment would be corrected.
 
“If these policy updates are accepted and implemented by CMS, barriers will be removed and Medicare patients will have much improved access to CTPs in Provider-Based Departments regardless of the size or location of their wounds,” the Alliance noted to CMS. Both recommendations above have been approved by CMS’ Advisory Panel on Hospital Outpatient Payment twice—in 2021, and again in 2022.

Issue only HCPCS “Q” codes for CTPs, not “A” codes that mischaracterize CTPs as “supplies.” The Alliance adamantly opposed CMS’ proposal to change HCPCS coding for CTPs from “Q” codes to “A” codes (supply codes)—a cross-over issue from the Agency’s proposed 2023 Physician Fee Schedule that will also have significant impact in the hospital outpatient setting.
 
Why this matters to wound care: The proposal to transition to A codes “not only creates unneeded work and confusion in light of the many years of the use of Q codes for such products, but A codes for skin substitutes do not capture the therapeutic significance of these treatments. CTPs are not supplies—based both on technological reasons and on how they are used clinically.” Opposition to the coding change—and its detrimental impact to patient access and care – was also a focus of the Alliance’s recently submitted comments to the 2023 Physician Fee Schedule.
 
The Alliance identified additional crossover issues of concern: if the Fee Schedule proposal to no longer require manufacturers of CTPs to submit average sales price (ASP pricing) is finalized, “the Agency would be bound by this decision and therefore would not accept ASP pricing for inclusion in the payment methodology in the outpatient setting. We believe that not including ASP for calculating payment in the outpatient setting will be detrimental to the Agency and will move away from long standing requirements placed on CTPs to report ASP,” the Alliance told CMS.

Don’t change the “skin substitutes” nomenclature to “wound care management products”; use “CTPs” instead. The Alliance expressed disagreement with CMS’s proposal to rename “skin substitutes” as “wound care management products”—which the Alliance characterized as a “confusing and overly broad” term.
 
Why this matters to wound care: CMS has indicated that the reason for the change of nomenclature is to provide a “more accurate and meaningful term” to help address confusion among interested parties about how these products are described and how they are paid for. “Yet, CMS goes through great lengths describing this term by stating what is and is not included … If the Agency has to go through such lengths to explain what the nomenclature means—it will not help to provide any clarity especially when clinically the term includes more products than the class of products it is meant to describe,” the Alliance noted.
 
The Alliance recommends that CMS instead use the more clinically accurate term “cellular- and/or tissue-based products for skin wounds (CTPs)” or “cellular, synthetic and/or tissue-based products (CSTPs).”
 
See the Alliance’s full comments submitted to CMS on Sept. 13, 2022.
 
About The Alliance of Wound Care Stakeholders
 
As the leading voice of wound care advocacy for the past 20 years, the Alliance unites leading wound care organizations and experts through advocacy and educational outreach in the regulatory, legislative and public arenas to advocate on public policy issues that may create barriers to patient access to treatments or care. With a key focus on coding, coverage and reimbursement, quality measures, and wound care research, the Alliance has enabled the wound care clinical community to collaborate, elevating the visibility and united voice of wound care providers to regulators and policymakers. For more information visit www.woundcarestakeholders.org.
 
Marcia Nusgart, RPh, is the executive director of the Alliance of Wound Care Stakeholders—an association of medical specialty societies, clinical and patient associations whose mission is to promote quality care and access to products and services for people with wounds. Through advocacy and educational outreach in the regulatory, legislative, and public arenas, the Alliance unites leading wound care organizations and experts to advocate on public policy issues that may create barriers to patient access to treatments or care.

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