CMS Releases 2023 Medicare Physician Fee Schedule

The Centers for Medicare and Medicaid Services (CMS) recently released its 2023 Physician Fee Schedule, which does not include any of the proposed seismic payment changes for cellular- and/or tissue-based products for skin wounds (CTPs, also known as skin substitutes) that could have caused a significant barrier to access.
 
Thanks to the tenacious advocacy of the wound care community, led by the Alliance of Wound Care Stakeholders, CMS’ proposal to treat and pay for CTPs as “incident to supplies” under the practice expense was not included in the Agency’s final 2023 Medicare Physician Fee Schedule that was issued in early November.
 
Here’s an overview of the Physician Fee Schedule final rule, policies, advocacy, outcomes, and opportunities for you to have your voice heard.

What Was Proposed

There were many hundreds of policy provisions in the 2,000+ page draft of the 2023 Medicare Physician Fee Schedule issued in June for public comment. Most relevant to wound care was CMS’ proposal to reclassify all CTP products as “supplies incident to a physician service” and package payment into the physicians’ practice expense. In short, CMS would no longer pay physician offices separately for CTPs under the traditional Average Sales Price (ASP) +6% payment methodology but would instead reassign all CTP products which have HCPCS “Q” codes to “A” codes (supply codes) and then pay for CTPs as “supplies incident to a physician service.” CMS also proposed to change its “skin substitutes” nomenclature to “wound care management products.”

What Advocacy Focused On

The Alliance, our members, and many allies submitted numerous comments, each flagging the unintended barriers to care and the patient access impacts of the proposed new payment provisions. With the compression of payment, we and many others felt that physicians would likely not be able to absorb the cost of purchasing CTPs if they’re not receiving adequate reimbursement to provide this advanced therapy. This would create a barrier to care for patients who could benefit from receiving a CTP, in turn resulting in a potential increase in infections and amputations.
 
We urged CMS to remove or delay the proposed CTP provisions until patient access issues could be further studied and vetted. We escalated the issue to select members of Congress, who in turn sent letters to the CMS Administrator—elevating the concerns that in the same rule where CMS specifically called amputation avoidance in patients with diabetes a “priority clinical topic,” the Agency proposed policy changes that are likely to lead to more patients receiving amputations. We questioned the shift in nomenclature to “wound care management products,” an overly broad a term that would cause confusion with evaluation and management (E/M) coding.

What We Won With a Unified Wound Care Voice

CMS ultimately heard and acted on the concerns of the wound care community. The Agency’s final 2023 Medicare Physician Fee Schedule, issued in early November, did not include the proposed CTP payment changes nor the change in nomenclature—a huge advocacy win for wound care providers and the patients we treat. Instead of taking action now, CMS will convene a Town Hall with interested parties in early CY 2023 to discuss alternative potential payment approaches for skin substitute products prior to CY 2024 rulemaking.  
 
In its summary of the final 2023 Physician Fee Schedule, CMS stated: “After reviewing comments on the [skin substitute] proposals, we understand that it would be beneficial to provide interested parties more opportunity to comment on the specific details of changes in coding and payment mechanisms prior to finalizing a specific date when the transition to more appropriate and consistent payment and coding for these products will be completed. We plan to conduct a Town Hall in early CY 2023 with interested parties to address commenters’ concerns as well as discuss potential approaches to the methodology for payment of skin substitute products” for future rulemaking.” During the Town Hall meeting, CMS is interested in hearing about nomenclature as well as changes to their payment approach.

Problems Avoided (for Now)

o   Inadequate CTP payment that would limit ability to provide CTPs to patients—AVOIDED:
The Agency’s proposed payment approach would have significantly limited the ability of clinicians to purchase, provide, and get adequately reimbursed for CTPs for their Medicare patients. Packaging payment for CTPs as supplies “strips the very payment mechanism that currently allows these advanced therapies to be provided in physician offices,” which currently receive invoice or ASP +6% as a separate payment, the Alliance had alerted CMS. “Physicians will not be able to absorb the cost of purchasing CTPs by not receiving adequate payment to provide this advanced therapy. 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.”
 
o   Payment policies that fly in the face of amputation prevention—AVOIDED:
Studies show that when advanced therapies such as CTPs are used, there are lower incidence of minor and major amputations for patients with lower extremity diabetic ulcers.¹ Yet without adequate reimbursement, many physicians will no longer be able to afford to provide these medically necessary advanced treatments to their patients with chronic, nonhealing wounds. This would deprive patients of these valuable treatment options which, in turn, could ultimately result in an increase in infections and amputations for patients with chronic non-healing wounds.

What’s Next

The removal of the problematic CTP payment provisions from the 2023 Medicare Physician Fee Schedule is an important example of an advocacy “win” shared across the many stakeholders in the wound care community who made their voices heard by submitting comments to CMS. This included the Alliance, clinical associations, medical specialty societies, manufacturers, wound clinics, wound care provider groups, and individual clinicians. These issues will need to continue to be explored and active dialogue continued with CMS as the Agency has indicated its intention to still move forward in creating a consistent payment approach for the suite of products they referred to as skin substitutes.

Your voice matters. Weigh in as policies move forward.

The Alliance will continue to advance and elevate wound care issues and will ensure that CMS fully understands the impacts of the policies it proposes, including and especially evolving CTP payment policies. We will be in dialogue with CMS about the Town Hall meeting it intends to convene in 2023, and will no doubt be there armed with numerous policy recommendations and solutions. Importantly, CMS always takes serious comments from clinicians—be it from professional clinician groups and/or from individual clinicians who see and treat patients with wounds every day.

Follow the Alliance on LinkedIn for updates on policies and opportunity to comment. Your voice is needed. Your voice is important. Your voice has impact.
 
Marcia Nusgart, RPh, is the Chief Executive Officer 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.

Reference
 
1. Armstrong DG, Tettelbach WH, Chang TJ, et al. Observed impact of skin substitutes in lower extremity diabetic ulcers: lessons from the Medicare Database (2015–2018). J Wound Care. 2021; 30(7).