By Kym McNicholas, CEO, Global PAD Association
A crisis is unfolding in American healthcare that has remained largely hidden from public view despite its staggering human and economic costs. Every year, approximately 150,000 Americans undergo lower limb amputations due to advanced stage peripheral artery disease (PAD)—a condition likened to “cancer of the legs” by medical professionals. With lifetime healthcare costs exceeding $100 billion, these amputations represent both a human tragedy and economic burden. What’s particularly alarming is that PAD affects nearly 20 million Americans, making it more prevalent than breast cancer, prostate cancer, and colon cancer combined, yet it receives a fraction of the attention and research funding.
What most don’t realize is that many of these life-altering surgeries are potentially preventable—if patients could access the advanced care they need. At the center of this crisis is a troubling trend: insurance giants like Humana (NYSE: HUM), Aetna, a CVS Health Company(NYSE: CVS, UnitedHealthcare (NYSE: UNH), and various Blue Cross Blue Shield Association (Especially Blue Cross Blue Shield of Michigan led by CEO Tricia Keith where a patient, Scott, tells me they dropped the CLI Operator who saved his leg) have Medicare Advantage plans that are systematically restricting access to advanced limb-saving procedures while readily funding amputations.
Humana's latest policy limitations I recently obtained, created by a team now led by CEO Jim Rechtin are a great example of what's happening where they target sophisticated techniques that can restore blood flow to dying tissue in the lower legs and feet—the very procedures that represent the last hope for patients facing limb loss.
For investors and industry watchers, this isn’t just a medical issue—it’s a case study in how misaligned incentives create enormous market inefficiencies and human suffering, while simultaneously opening opportunities for disruptive innovation.
The Growing Epidemic Nobody’s Talking About
What makes this situation particularly alarming is the perfect storm brewing in American health. We’re witnessing an unprecedented rise in late-stage peripheral artery disease (PAD), known clinically as critical limb-ischemia (CLI). While PAD traditionally affected larger vessels above the knee, the current epidemic is manifesting as a “bottoms up” disease pattern—primarily targeting the smaller vessels in the foot and calf first.
This shift to predominantly below-knee, smaller vessel disease is critically important because the evidence base and treatment guidelines for these anatomical regions haven’t kept pace with the disease’s evolution. Current treatment protocols were largely developed for larger vessel disease, while this new wave of smaller vessel disease presents unique challenges that require specialized approaches.
Driving this surge are two major risk factors reaching epidemic proportions: diabetes and chronic kidney disease. These conditions specifically damage smaller vessels and often present without the classic progression of leg cramps or intermittent claudication that responds to walking therapy and medication. Instead, patients suddenly appear with non-healing wounds or debilitating nighttime pain when the only remaining options are advanced intervention or amputation.
The tragedy? When insurance restricts coverage for specialized below-knee and foot procedures, they’re effectively removing every option except amputation from the physician’s toolkit.
The Technology Insurance Doesn’t Want You to Access
When PAD advances to critical stages, especially in the smaller vessels below the knee and in the foot, specialized techniques become necessary to restore circulation.
These advanced limb salvage procedures include atherectomy (precision devices that remove arterial plaque), specialized balloon angioplasty, and targeted drug delivery systems. For patients with severe disease, these techniques often represent the difference between keeping a limb and losing it.
The technical challenge of treating these vessels cannot be overstated. The vessels below the knee and in the foot are often no wider than a coffee stirrer, making standard approaches frequently inadequate for restoring blood flow effectively.
But Humana’s policy—citing “insufficient evidence” on the use of these limb salvage tools and techniques—now restricts coverage for these procedures in precisely the anatomical areas where they’re most needed.
Really?
This creates an absurd scenario where insurance will not cover the cost of advanced procedures that might save a limb based on ‘insufficient evidence.’
Yet there’s plenty of evidence that shows that not saving it will increase a patient’s mortality rate.
The Evidence Double Standard
The most troubling aspect of this crisis may be the selective scrutiny of evidence by insurance companies. When it comes to limb-saving procedures, insurers demand gold-standard proof, but when it comes to amputations—which carry significantly higher mortality rates—they require virtually no evidence at all.
Humana’s recent policy limiting coverage for atherectomy in infrapopliteal arteries claims there is an “absence of current, widely-used treatment guidelines or acceptable clinical literature examining benefit and long-term clinical outcomes.” This statement is demonstrably false. A comprehensive systematic literature review presented at VIVA 2024 identified over 300 original research articles on atherectomy outcomes, including high-quality meta-analyses, randomized trials, and multicenter observational studies. One meta-analysis specifically demonstrated that atherectomy followed by drug-coated balloon angioplasty reduced amputation risk by 44% compared to drug-coated balloon angioplasty alone.
Yet Humana and other insurers conveniently ignore this substantial body of evidence while selectively citing research such as by Dr. Caitlin Hicks of Johns Hopkins. Her retrospective analysis of Medicare data suggested a correlation between certain interventional procedures and subsequent amputations. It's important research taken out of context by insurance companies. Insurers have seized on this association to claim that procedures like atherectomy might actually increase amputation risk—despite the fact that the correlation made doesn’t prove causation, especially in retrospective analyses. Plus, the patients in question who are being denied these procedures are already a toe stub away from amputation, not in the early 'intermittent claudication stage.'
What these insurers fail to mention is that Dr. Hicks herself acknowledges that “atherectomy has its time and place” and can be appropriate in certain cases. Her concern was about potential overuse in patients with mild symptoms (which is also a very serious issue), not about denying these procedures to patients facing imminent limb loss. Yet insurance companies have leveraged research like hers to create barriers for all patients, including those for whom these procedures represent the last hope to save a limb.
The insurance double standard becomes even more striking when you look at what they’re willing to approve without question. Research by Dr. Eric A. Secemsky, MD, MSc, RPVI, FACC, FAHA, FSCAI, FSVM of Beth Israel Deaconess Medical Center revealed that more than 60% of amputations are performed without any attempt to restore blood flow in the year prior to amputation, with 90% occurring without a vascular evaluation at all. So, the majority of amputations are performed not due to too many attempts to save the limb, but none at all. Yet these amputation procedures receive automatic insurance approval with no questions asked -- even though this physician behavior does not align with American Heart Association and Society for Vascular Surgery guidelines which state that a full vascular evaluation should be performed AND an attempt to restore inline blood flow should be made prior to any amputation.
It’s important to emphasize that there is absolutely no credible medical evidence suggesting that proceeding directly to amputation without attempting revascularization leads to better outcomes. In fact, all available data points in the opposite direction—patients who receive interventional procedures have better survival rates, better quality of life, and better functional outcomes than those who undergo primary amputation. Yet insurance companies continue to create barriers to these procedures while fast-tracking amputations, a policy stance completely unsupported by medical evidence.
The contrast is impossible to ignore: insurance companies express grave concern about interventional procedures potentially leading to amputation in some cases, yet show zero concern about the vastly more common practice of proceeding directly to amputation without trying any limb-saving measures first.
Humana’s policy even explicitly rejects innovative “last chance” interventions like deep vein arterialization—procedures that may represent the final hope for patients who have exhausted all conventional options. This policy flies in the face of clinical evidence from multiple studies, including the PROMISE I early feasibility study and the ALPS Multicenter Study, which demonstrate that deep vein arterialization significantly improves amputation-free survival by up to 29% in “no-option” patients who would otherwise face certain amputation. When Humana claims there’s “insufficient evidence” for these procedures, they’re deliberately ignoring robust clinical data that could save patients’ limbs and lives.
This approach of applying extraordinarily high evidence standards to limb-saving procedures while requiring virtually no evidence for amputation authorization speaks volumes about the company’s true priorities.
The mortality implications of this double standard cannot be overstated. Research from the Journal of Vascular Surgery shows that patients undergoing primary amputation face mortality rates approaching five times that of the general diabetic population, with a startling 48% mortality rate within just one year of major amputation. Even more concerning, the five-year survival rate after major lower extremity amputation can be as low as 30-35%, worse than many forms of cancer.
These alarming mortality statistics further strengthen the case for limb salvage. Studies consistently demonstrate that patients who receive successful limb-saving procedures have significantly better outcomes, with research showing that 74% of patients maintain or improve their ambulatory status following limb preservation. This improved mobility is critical—especially considering that 3 in 5 people who suffer heart attacks have PAD, and maintaining ambulation significantly reduces cardiovascular mortality.
The situation has become so egregious that it demands a new level of oversight. When insurance companies selectively interpret evidence to deny life-altering procedures—particularly when their policies directly contradict the recommendations of multiple medical societies—patients deserve transparency. At minimum, insurers like Humana should be required to have their evidence standards and policy-making data reviewed by an independent government board, ensuring that coverage decisions aren’t being driven purely by financial considerations.
This isn’t about whether a specific procedure deserves universal approval—it’s about applying consistent evidence standards across all treatment options. When insurance companies readily approve amputations without requiring evidence of attempted limb salvage, while simultaneously denying coverage for procedures that might prevent those same amputations, the message couldn’t be clearer: insurance policies favor immediate amputation over evidence-based limb preservation, regardless of what medical science or professional guidelines recommend.
The Financially Perverse Healthcare Market
When you examine this behavior from a financial perspective, perhaps this “Let’s not bother” mentality versus “Let’s try” to save a leg mentality makes sense for insurance companies.
At first glance, however, it may defy logic.
An amputation costs approximately $30,000 to $40,000 in immediate surgical expenses. However, the lifetime cost of an amputation—including prosthetics, rehabilitation, home modifications, and lost productivity—often exceeds $500,000 per patient.
Advanced limb salvage procedures typically cost between $10,000 and $20,000. Even accounting for potential reinterventions, the cost-benefit analysis overwhelmingly favors attempting limb preservation first.
So why would insurers prefer the more expensive long-term option? The answer reveals troubling incentives within our healthcare system. The financial calculus becomes clearer when examining medical outcomes data. Research shows that patients who undergo amputations face dramatically higher mortality rates—studies document one-year mortality rates between 38.3% to 40%. By three years post-amputation, mortality rates exceed 60%.
This high mortality rate is linked to the significant burden of comorbidities in these patients. Those undergoing major amputations for CLI typically have multiple chronic conditions that are already costly to treat—diabetes, cardiac disease, and renal failure chief among them. The decline in mobility following amputation further accelerates cardiovascular decline.
When a patient dies within a year or two of amputation, the insurer avoids hundreds of thousands in long-term care costs. The math is brutal but straightforward: pay $40,000 for an amputation now, or risk ongoing treatments for a patient with multiple chronic conditions who might live for years with an intact limb.
What’s even more troubling is that now, instead of following through on recent agreements with HHS Secretary RFK Jr. to minimize pre-authorization barriers, insurance companies are simply dropping physicians who specialize in these limb-saving procedures from their networks entirely. This effective elimination of specialists represents a disturbing new tactic—one that circumvents any promise of streamlining approvals by removing patient access to qualified providers in the first place.
The insurance company calculus ignores what any patient would tell you: “I’d rather you give it the grand old try to save my leg versus taking the lazy way out and just cutting it off, even if it means multiple procedures.”
Shouldn’t healthcare be about improving the quality of life for patients?
The Human and Economic Cost: Real Lives at Stake
Behind the statistics and market dynamics are real patients whose lives are permanently altered by these policies. These aren’t just abstract economic calculations—they represent thousands of Americans caught in a system where insurance decisions override physician expertise, often with devastating consequences.
Consider Thomas from Louisiana, whose doctor has successfully kept him ambulatory for three years through periodic minimally invasive procedures—despite his first physician recommending immediate amputation. Thomas maintains an active lifestyle, continuing to work and exercise regularly. Yet each time he needs a procedure—typically when pain already wakes him from sleep—his insurance company forces him to endure weeks or months of waiting for approval.
In his most recent experience, after enduring two months of nightly suffering, his insurer denied the minimally invasive procedure his specialist recommended, instead suggesting a major bypass surgery. This decision came from a doctor who had never examined Thomas, spoken with him, or reviewed his complete medical history—despite clear documentation that Thomas is not a surgical candidate. The only approach that works for him is periodic interventional procedures, combined with walking and medication.
Another patient’s story reveals how delays can be catastrophic. After presenting with a gangrenous toe, her doctor recommended using balloon angioplasty and atherectomy to restore blood flow through the small vessels below her knee. The insurance company initially denied the procedure. Though they eventually approved it after a peer-to-peer review, the delay proved devastating. By the time approval came through, the patient had already undergone a below-knee amputation. The hospital doctor, unfamiliar with below-knee revascularization techniques, had convinced her that saving her leg wasn’t possible.
If only insurance had approved the procedure by a doctor who would at least follow Society for Vascular Surgery and American Heart Association guidelines to at least try to restore inline flow prior to amputation, she might have a better quality of life.
Instead, she is suffering both physically and emotionally enduring a long recovery in a rehabilitation facility away from her family. The emotional and psychological impacts of an amputation are real. Amputations inflict profound psychological wounds that often parallel the physical trauma itself. Approximately 21-35% of amputation patients experience clinical depression, significantly higher than the 10-15% rate in the general population, with many also developing anxiety and post-traumatic stress disorder due to altered body image and perceived loss of independence. The emotional journey mirrors the intense grief experienced after losing a loved one, as patients struggle with a distorted sense of self, social isolation, and the devastating fear of being seen as "incomplete" - psychological effects that can persist long after the physical wounds have healed.
Even worse, for the 85% of patients with diabetes, the amputation often accelerates the decline of other systems. That increases the economic toll far beyond the initial amputation cost -- increasing hospitalization rates and medication requirements. Many amputees also require extensive modifications to their homes and vehicles. Plus, they face significantly reduced earning capacity—over 60% never return to full employment.
So, when we talk about a $100 billion amputation crisis, we’re discussing not just healthcare spending, but the collective human and economic toll on individuals, families, and communities across America.
Policy Solutions and Market Innovation
Addressing this crisis requires a multi-pronged approach, with both policy reforms and market innovations working in concert. The ARC Act represents one important component—by mandating PAD testing for all patients with high-risk factors, it would enable early detection and intervention before patients advance to critical stages. Early detection means early treatment that can stall disease progression, even for those with diabetes and chronic kidney disease.
However, we can’t wait for a single comprehensive solution. We must act now on multiple fronts to address the insurance bottleneck that’s costing patients their limbs and lives. We need to ensure insurance companies support doctors’ efforts to save limbs, even if that means multiple procedures for some patients.
If insurers truly care about evidence-based medicine, they should apply the same rigorous standards to all procedures—including amputations. They should demand vascular evaluation before approving any amputation, in accordance with clinical guidelines. They should eliminate the practice of retroactive denials after providing authorization. Most importantly, they should acknowledge that their primary expertise is in finance, not medicine—and defer to qualified clinicians on complex treatment decisions.
From a policy perspective, Medicare and regulatory agencies should consider:
Requiring adherence to clinical guidelines before amputation approval
Implementing true value-based payment models that reward limb preservation
Creating transparency requirements around network adequacy for limb preservation specialists
Reforming insurance incentives so that the financial burden of poor long-term outcomes from amputation remains with the insurer who denied limb-saving care
For investors and industry leaders, the opportunities lie in:
Value-based care models specifically targeting amputation prevention
Technology innovations that can navigate the challenging below-knee and foot vessels
Telehealth platforms connecting patients with limb preservation specialists regardless of geography
Data analytics solutions that identify high-risk patients before emergent situations develop
These policy and market solutions represent more than just business opportunities—they offer a path to realigning our healthcare system around what should be its primary goal: preserving life and function.
The fundamental question isn’t whether atherectomy or any specific procedure deserves blanket approval. It’s whether we want a healthcare system where insurance companies increasingly control treatment decisions while applying wildly inconsistent evidence standards depending on financial implications.
As I recently wrote to our patient community: “The BIGGEST reason people are losing limbs to amputation is NOT because they’re getting too many endovascular procedures. It’s because they’re getting too few or NONE AT ALL.” This isn’t just my opinion—it’s what the hard data shows.
Would we accept an insurance company telling cancer patients they’ve had too many chances at survival? Of course not. So why is “cancer of the legs” treated differently?
We need accountability on BOTH sides—for those doing too many procedures AND for those too quick to amputate. But dropping dedicated specialists from networks only hurts the patients who need them most.
For those facing limb loss, the stakes couldn’t be higher. Every day that insurance companies delay appropriate care, patients move closer to preventable amputations. Every policy that restricts physician options without meaningful clinical input potentially condemns patients to unnecessary disability.
As patients, investors, and industry leaders, we must demand greater transparency around coverage decisions, question policies that substitute administrative judgment for clinical expertise, and recognize when evidence is being selectively interpreted to justify predetermined financial outcomes.
For PAD patients specifically, we must ensure access to the full range of treatment options appropriate for their individual situations—before it’s too late. Because in the battle between insurance profits and patient limbs, there’s no question which should take priority.
References:
Secemsky EA, et al. Association of Lower Extremity Endovascular Revascularization With Major Adverse Limb Events and Mortality. JAMA Netw Open. 2022;5(8):e2226561.
American Medical Association. 2023 AMA Prior Authorization (PA) Physician Survey. AMA Advocacy Resource Center.
Barshes NR, et al. The contingent value of a lower extremity amputation: a preliminary economic model of clinical and economic factors. Journal of Vascular Surgery. 2019;70(5):1648-1657.
Society for Vascular Surgery. Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. 2019;58(1S):S1-S109.e33.
Creager MA, et al. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease. Circulation. 2019;140:e596–e646.
Carr J, Secemsky E, et al. A Systematic Review of Peripheral Atherectomy: Evidence and the Opportunity for Future Guidance. Presented at VIVA 2024.
Fanelli F, et al. Atherectomy for Lower Limb Revascularization: A Systematic Review and Meta-Analysis. Journal of Endovascular Therapy. 2023;30(2):211-224.
Clair DG, et al. PROMISE I: Early feasibility study of the LimFlow System for percutaneous deep vein arterialization in no-option chronic limb-threatening ischemia: 12-month results. J Vasc Surg. 2021;74(5):1626-1635.
Schmidt A, et al. Midterm outcomes of percutaneous deep venous arterialization with a dedicated system for patients with no-option chronic limb-threatening ischemia: the ALPS Multicenter Study. J Endovasc Ther. 2020;27(4):658-665.
McKechnie, P. S., & John, A. (2014). Anxiety and depression following traumatic limb amputation: A systematic review. Injury, 45(12), 1859-1866. https://doi.org/10.1016/j.injury.2014.09.015.
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