CMS Crackdown on Cellular and Tissue-Based Products: A Clinician’s Perspective on Evidence, Access, and Prevention
As CMS seeks to tighten coverage and utilization controls for cellular and tissue-based products (CTPs), clinicians are being asked to balance evidence, access, and administrative burden in real-world wound care. In this Q&A, a wound care clinician weighs in on where regulators are getting it right, where policies may go too far, and how payment reform could shift the focus from advanced therapies to true prevention.
Key Takeaways
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Evidence will determine survival: CMS policy, FDA pathways, and stronger evidence expectations are likely to shrink the CTP market to a smaller, more rigorously studied group of products—pushing “me-too” offerings out and encouraging meaningful innovation.
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Rigid utilization controls carry risk: While evidence-based thresholds and healing trajectory expectations are needed to curb overuse, uniform caps and narrowing of coverage categories may unintentionally limit access for patients whose wounds are healing more slowly but appropriately.
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Prevention must be financially rewarded: Sustainable reform will require payment models that incentivize diabetic foot ulcer prevention—such as surveillance, early intervention, and limb preservation—at least as much as downstream procedures like CTP application.
From your perspective as a clinician who has used cellular and tissue-based products (CTPs), how do you view recent Centers for Medicare and Medicaid Services (CMS) actions aimed at tightening coverage, utilization controls, and product eligibility—and wh
Throughout my career, I have used CTPs extensively, and I am appreciative for the role they have played in helping heal wounds among the patients I have treated. I have practiced in the Veterans Administration, where it traditionally was very easy to utilize CTPs, as well as in an academic facility where access is dependent upon formulary regulations and insurance approval. Frankly, I am thankful that there has been recent thought given by CMS to this topic as, unfortunately, we are all aware of past overuse and abuse of these products for financial gain.
Where I think CMS is on the right track on this issue is potentially requiring an evidence-based, standardized approach to CTPs in the future. I believe that linking coverage to products that have peer-reviewed data would be helpful. In my opinion, there are too many “me too” products in the CTP world and linking coverage to evidence-based medicine may actually weed-out the unnecessary “extra” products, but more importantly, potentially foster true innovation for future products. Another area that I think heads us in the right direction is a focus on the trajectory of healing after CTP application. As clinicians, we have evidence-based guidelines about the lack of 50% healing at 4 weeks1 suggesting the use of CTPs but there are no guidelines or expectations for wound progress after application. In my opinion, this has been a “miss” in the wound care community and likely contributed to the overuse seen. I do believe some of the burden in this case should fall back to industry to help support trials on CTP “dosing” outcomes.
Where I feel CMS may potentially go too far is if they enact a very narrow coverage category to the exclusion of some products which may in fact, have evidence-based medicine support. Going to consolidated, lower payment models will likely, in my estimation, affect hospital-based wound centers who will be unwilling to “go through the hoops” at a financial loss. Additionally, previously proposed, and later withdrawn uniform caps and iron-clad guardrails on use were too rigid and potentially may have halted progression of a wound that is in fact, on a healing trajectory but slower than the “every patient must fit into a box” algorithm. I strongly feel that the point-of-care approach should be individualized to the patient case. And, as always, the explicit documentation and administrative burden for approval, under many circumstances (such as in the WISeR program), is always a negative factor that I observe in patient care.
The explicit goal statements from CMS of maintaining access, rewarding clinically-effective care, and incentivizing products that improve outcomes while lowering long‑term costs make a lot of sense to me. In a perfect world, I think there would be evidence-based guidelines on when to apply, clinical expectations and guidelines for repeat applications, and a pathway for some flexibility for the provider in “edge cases.” Incentivizing providers and wound clinics to heal wounds using these products through a value-based approach may prove most advantageous.
You’ve acknowledged both the clinical value of CTPs and the reality that there are “too many products on the market.” In your view, what role should evidence standards, FDA pathways, and Medicare coverage policies play in determining which CTPs remain via
I feel that evidence-based standards, FDA pathways, and Medicare policy will likely become the main market‑shaping forces for CTPs, favoring a much smaller group of well‑studied, clearly regulated products while pushing many “me‑too” out of practical viability. I have always placed a lot of value on those products that have solid evidence-based studies behind them. I appreciate the time, effort, and financial backing many companies have put into research and those products have always been my “go-to.” We don’t need more products, we need more data on who, when, and how to use these products. Large registry data can help. New RCTs specifically focused on high-risk patients like end-stage renal disease (ESRD) patients as well as underrepresented minority populations, could have a significant effect on reducing healthcare disparities and give us better knowledge of appropriate expectations for this category of products. I personally think a smaller formulary of well-studied products is completely appropriate. What I would like to see is an expansion of knowledge around the products we have, not more products and I think the new model may promote that action.
As your practice has shifted toward greater emphasis on DFU prevention, how do you think payment policy and regulatory frameworks could better incentivize prevention strategies rather than downstream advanced therapies like CTPs—and what would meaningful
I am reminded that one way to lower amputation rates is to not have a surgeon available. When patients refuse amputation or it is not an option, in my observation we try harder at limb salvage. Maybe CTPs have a significant role in this population. However, if we prevented more wounds, the need for CTP use would naturally decrease. Prevention is the answer, especially with literature supporting the fact that 75% of DFU are preventable.2 I don’t think most of our practices are meeting that mark for a myriad of reasons inclusive of the patient, provider, and healthcare system perspectives. I feel that prevention will only be prioritized when payment and regulatory rules reward limb preservation outcomes and early‑risk management at least as much as they currently reward procedures like CTP application. In a fee-for-service model, the incentive will always remain on downstream interventions. CTP use, debridements, and even amputation have clear fee‑for‑service codes and relatively predictable payment, whereas DFU prevention strategies such as remote foot temperature monitoring, proactive shoe and orthotic interventions, and nurse‑driven surveillance are either not coverd, time‑limited, or inconsistently available. The potential framework allowing committed providers or clinics to fully lean into prevention requires unique payment models. Providers and clinics need to be rewarded for keeping patients out of the emergency room and hospital with diabetes-related complications. Keeping patients at home, including adoption of technology to promote access and surveillance, will be critical. We have the statistics with known financial models of what this population can cost the healthcare system so potentially benchmarking shared savings opportunities with providers and clinics would be motivating to keep people wound-free. Instead of a bonus based on revenue which generally promotes procedural work, we should consider quality‑linked bonuses for providers and systems that document high rates of preventive care including annual comprehensive foot exams, therapeutic footwear, neuropathy assessment, timely vascular referral and low major amputation rates. Prevention is possible and should be rewarded – it is both clinically effective and cost effective.
Dr. Rothenberg is a dually appointed Adjunct Clinical Associate Professor of Surgery in the Division of Vascular Surgery and Internal Medicine in the Division of Metabolism, Endocrinology, and Diabetes at the University of Michigan Medical School. He currently serves as the Director of Fellowship Training in Limb Preservation Research at Michigan Medicine and is the newly installed President of the American College of Podiatric Medicine.
Dr. Rothenberg discloses that he is the Director of Medical Affairs for Podimetrics.
References
1. Serena T, Sadia Y, Yaakov R, King E, Driver VR. Percentage area reduction at week 4 as a prognostic indicator of complete healing in patients treated with standard of care: a post hoc analysis. J Wound Care. 2024;33(Suppl 9):S36-S42. doi:10.12968/jowc.2024.0141
2. Bus SA, van Netten JJ. A shift in priority in diabetic foot care and research: 75% of foot ulcers are preventable. Diabetes Metab Res Rev. 2016;32(Suppl 1):195-200. doi:10.1002/dmrr.2738
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