The Positive Side of the Local Coverage Determination Changes

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Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of Wounds or HMP Global, their employees, and affiliates.

Dear Readers:

Over the last year, all of us involved in the treatment of chronic wounds have heard a great deal about the local coverage determination (LCD) changes. For many, the discussion may feel overly focused on cost, policy, and utilization. For some clinicians, “skin substitutes” represent only a small part—or no part—of their therapeutic armamentarium.

If you have little “skin in the game” regarding the actual cost of these products, your questions are straightforward: Does it work? Where can I use it? How easy is it to use? For another segment of the wound care world, however, the “skin substitute” market has been a major economic driver for years. That market has attracted substantial investment and has consumed significant clinical research time and energy. I have been personally involved in this work for quite some time.

I am not going to use this platform to argue where the therapeutic road should intersect with regulatory and industry roads. Instead, I want to highlight one hopeful, unintended consequence of the current clear-cut changes—and the possibility of additional, less certain changes—in coverage for “skin substitutes.” Ongoing uncertainty in this market may redirect scientific and economic capital toward other potentially helpful diagnostic and therapeutic interventions that are currently less readily reimbursed.

Our field continues to face a persistent lack of adequate diagnostics. Over the last half decade, multiple imaging systems have become available, and many clinicians have heard about them or begun using them. Yet reimbursement for these technologies—and the scientific evidence supporting them—continues to lag behind clinical need. If we redistribute our economic and scientific energies, we may be able to advance diagnostic approaches without having to tie them to “skin substitutes.”

The same may be true for other adjunctive technologies that merit continued exploration and may benefit from increased financial and clinical investment. A noncomprehensive list includes cold plasma, light therapy, ultrasound, and shockwave therapy—energy-based modalities with potential roles in wound care. In addition, topical antimicrobials that are simpler than some products we currently use may prove to be highly efficacious. At present, these lower-reimbursing options may be sidelined because of limited economic viability. With appropriate advocacy, however, reimbursement for effective, low-cost therapies could improve the overall health economics of the field in which we all work.

In closing, I do not view the LCD changes as a “sky is falling” event. Rather, they may create a Cloudy With a Chance of Meatballs moment—an opportunity to look for alternative pathways and adjunctive therapies that may be more cost-efficient. Ultimately, our goal should be to heal patients as quickly and as cost-efficiently as possible. This LCD “roadshow” that we created for ourselves is a chance to ensure that we move forward by doing the right thing.