CTPs: Can We Do the Right Thing for the Right Patients?

The Centers for Medicare and Medicaid services (CMS) recently issued a proposed rule for the 2023 Physician Fee Schedule (PFS) that makes sweeping changes to the way that cellular- and tissue-based products (CTPs)—often incorrectly called “skin substitutes”—are paid for in the office space setting.¹ Some of these changes will affect the hospital-based outpatient department (HOPD), too.
 
As part of the proposed changes, CMS would change the terminology “skin substitutes” to “wound care management products,” saying this would accurately reflect how clinicians use these products.² They argue that the changes will “provide a more consistent and transparent approach to coding for CTPs.” The proposed rule would treat and pay for CTPs as “incident to” supplies under the PFS beginning on January 1, 2024.
 
Comments are due to the CMS by Sept. 6. Click here to comment.
 
I will be quick to say I think office-based wound care has a great future. The problem here is not the site in which the care takes place. The problem is that you get exactly the system that you design. CMS created a system in which expensive CTPs could be used in the absence of appropriate basic care like arterial screening and offloading. Doctors who provide high quality care end up billing fewer CTP applications because they first correct underlying impediments to healing. CMS decided to place controls in the HOPD by limiting payment for CTPs to a fixed price regardless of the cost of the product. Even though utilization of CTPs in the hospital-based setting dropped, CMS focused most of its audits in the HOPD anyway.
 
Meanwhile, in the doctor’s office setting, CMS continued to separately reimburse the cost of the product and as far as I can see, made little effort at recoupment for improper use. CTPs became the cash cow for many doctor’s offices, some of which offer wound care only as a lucrative “side business.” The manufacturers were happy with the dramatic increase in utilization, the practitioners increased their revenue, and no doubt some patients got helped. However, a lot of patients did not get appropriate basic care first, and many patients paid large copays for treatments that they did not need or could not benefit from.
 
Medicare does not come up with these rulings in a vacuum. Dramatic changes in CMS policy are always in response to dramatic increases in utilization that do not appear to provide commensurate benefit to Medicare beneficiaries. Apparently, what has happened in my community is not an anomaly.
 
Naturally, great concern has been expressed about the impact these changes will have on vulnerable patients. However, we currently do not have any policies aimed at helping the patients who really need CTPs. Why? Because we’ve never identified who they are. The current overuse of CTPs reflects some patients who likely did not need CTPs to heal, and some patients who could not benefit from them because they needed other types of care that were not provided.
 
Somewhere in the mix are the patients who both needed and could benefit from CTPs. We currently have the data to identify which patients need and can benefit from CTPs, but there’s been no desire to identify this subset because it might mean reducing unnecessary use. To fix the lack of appropriate basic care, the US Wound Registry even had a CMS-approved quality measure focused on the appropriate use of CTPs (meaning using CTPs only on patients who’d had proper arterial screening and offloading) but doctors had no reason to report a burdensome quality measure when they got paid for CTPs regardless of the quality of care provided. Audits don’t seem to impact bad behavior since (as best I can tell) Medicare and the local contractors keep auditing the HOPDs.
 
CMS only has blunt tools to stop what appears to be abuse. While the mechanism is complex, they change behavior by changing payment. So, I’ll ask you the question. How would you protect access to CTPs for patients who really need them and who can also benefit from them because they’ve first had appropriate basic care? What percentage of patients do you think that is?
 
Caroline E. Fife is Chief Medical Officer at Intellicure Inc., The Woodlands, TX; executive director of the U.S. Wound Registry; medical director of St. Luke’s Wound Clinic, The Woodlands; and co-chair of the Alliance of Wound Care Stakeholders. Click here for Dr. Fife’s original blog.

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References
 
1. Centers for Medicare and Medicaid Services. Physician Fee Schedule.
2. Centers for Medicare and Medicaid Services. Calendar Year (CY) 2023 Medicare Physician Fee Schedule Proposed Rule.