Could Proposed Policy Changes in the 2023 Physician Fee Schedule Increase Amputations and Infections in Patients With Wounds?

The Alliance of Wound Care Stakeholders alerted the Centers for Medicare and Medicaid Services (CMS) last week that changes to the way cellular- and/or tissue-based products for skin wounds (CTPs, also known as “skin substitutes”) are coded and paid for in the physician office under the proposed 2023 Physician Fee Schedule will create barriers to care that could ultimately lead to increased amputations and infections for patients with chronic non-healing wounds. The Alliance urged CMS to remove or delay implementation of the proposed CTP provisions from the final 2023 Physician Fee Schedule until patient access issues can be further studied.
 
“Under the proposed 2023 policy, payments for CTPs and their application will simply not cover the costs to physician offices. Without this adequate reimbursement many physicians will no longer be able to afford to provide these medically necessary and successful advanced treatments to their patients. This would deprive patients these valuable treatment options which, in turn, could ultimately result in an increase in infections as well as amputations” the Alliance told CMS in comments submitted Sept. 6.

A Closer Look at the CTP Provisions and Their Impacts

CMS’ proposed policy reclassifies all CTPs as “supplies incident to a physician service,” and packages payment for these “supplies” into the practice expense associated with that service. This means:
·      CMS would no longer pay physician offices separately for CTPs under the traditional methodology of Average Sales Price +6% payment.
·      CTPs would be removed from the Medicare Part B pricing data file as pricing would now fall under the Physician Fee Schedule.
·      CMS would discontinue all existing CTP products’ Healthcare Common Procedure Coding System (HCPCS) “Q” codes (which are among the codes used to identify drugs and biologicals in Medicare billing). All CTP products would instead be assigned HCPCS “A” codes (supply codes) and paid as “supplies incident to a physician service.”
 
The impacts are significant to wound care providers and our patients in the following ways:
 
Policy ignores the therapeutic significance of CTPs. Reclassifying CTP as “supplies” ignores the therapeutic significance of CTPs. “CTPs are not supplies both for technological reasons and also on how they are used clinically,” the Alliance emphasized to CMS. “First, CTPs are affixed to a wound and become incorporated into the wound bed. This demonstrates that they are not supplies that are used and disposed of…Furthermore, CTPs have regulatory requirements placed on them that no other supply has, specifically, tissue tracking requirements. No supply has the same type of documentation requirements as CTPs or have any specifically identified Joint Commission accreditation requirements as stringent as those for CTPs. The reason: CTPs are not supplies.”
 
The Alliance questioned why CMS “has not offered any data, analysis, or evidence of any type that supports CMS’s proposed position to now classify all CTPs as supplies incident to a physician service, packaged into the practice expense associated with that service, rather than their longstanding treatment as biological products.” The Alliance adamantly opposes the proposed shift to “A” codes (supply codes) and strongly recommended that CMS continue to assign a Q code to CTPs when the requirements of the HCPCS application have been met.
 
Packaging payment for CTPs as “supplies” removes adequate payment, limits patient access. Concerningly, packaging payment for CTPs as supplies strips the very payment mechanism that currently allows these advanced therapies to be provided in the physician office, which currently receive invoice or ASP +6% as a separate payment. “Physicians will not be able to absorb the cost of purchasing CTPs by not receiving adequate payment to provide this advanced therapy,” the Alliance noted to CMS. “Mid-level providers will realize an even greater impact of this change, as they will only get reimbursed at 85% of the proposed packaged rate for physicians. This will result in a lack of access for patients who could benefit from receiving a CTP when provided in the physician office and as a result an increase in infections as well as amputations—both major and minor.”
 
Policy creates an access barrier at sites of service where outpatient facilities refer patients. Limited access in the physician office site of service is particularly concerning, as previous CMS policies have already created barriers to CTPs in provider-based departments (PBDs). In 2014, when CMS’ Outpatient Prospective Payment System (OPPS) packaged payment for CTPs, there was no payment for the add-on codes that were included into the bundled rates so that the PBDs could purchase the sizes of CTPs necessary to apply to all wound sizes. This resulted in an OPPS payment system that fails to provide adequate payment for PBDs to purchase a sufficient amount of CTP products for large wounds between 26 and 99 sq. cm, and over 100 sq. cm. To avoid prohibitive costs and financial losses, many PBDs as a result have not been offering these treatments and more frequently refer these patients to physician’s offices.

“Outpatient facilities under the current prospective payment system are losing money on these larger wounds … Thus the steady shift/increase in the number of claims submitted in this physician office setting, largely due to physicians being able to treat larger and more complex wounds in the office and being reimbursed appropriately for their work,” the Alliance wrote.

With the proposed changes to the 2023 Fee Schedule, the physicians’ office will also now face Medicare payments for CTP products that won’t match their costs, resulting in the reduced ability to offer CTP treatments in this site of service as well.

Now, physicians will also, like PBDs, “no longer be able to afford to provide these successful treatments to their patients. Therefore, patients may be pushed to seek access in the hospital emergency department—creating a cost burden to CMS—or have very limited access to this treatment in yet another site of service.”

Policy change is at odds with CMS’ priority to address amputations. In the FY2023 Physician Fee Schedule proposed rule, CMS expressly called out its concern with the number of amputations in patients with diabetes and included a specific Request for Information seeking quality measures to address amputation avoidance. “CMS has specifically stated that ‘amputation avoidance in diabetic patients is a priority clinical topic.’… Studies show that when advanced therapies such as CTPs are used on patients with diabetes there are lower incidence of minor and major amputations for patients with lower extremity diabetic ulcers. As such, it is particularly concerning that the Agency, in the same rule, proposes CTP policy changes that are likely to lead to more patients receiving amputations,” wrote the Alliance, as part of its recommendation that CMS remove, or at least delay implementation of, the CTP changes until the impacts are more fully vetted.
 
The Alliance also objected to CMS’ proposal to rename the term “skin substitutes” as “wound care management products” which the Alliance flagged as “misleading,” “confusing” and “overly broad.” Comments also addressed other provisions in the proposed policy impacting wound care, including the global surgical package, remote therapeutic monitoring, telehealth, and the clinical labor update. See the Alliance’s full comments submitted to CMS.
 
The Alliance of Wound Care Stakeholders is the leading voice of wound care advocacy, uniting leading wound care organizations and experts 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 enables the wound care clinical community to elevate the visibility and united voice of wound care providers to regulators and policymakers. Click here for more information.
 
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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