This is the second article in a four-part series examining America’s preventable amputation crisis. Read part 1 HERE.
“We’re sorry, but we cannot approve this procedure. There is insufficient evidence to support its use in your case.”
For Thomas from Louisiana, these words—delivered via a cold form letter—weren’t just a bureaucratic decision. They were effectively a sentence to amputation. (Watch: Faces of denial: When an insurance company played coctor, Thomas suffered)
With worsening peripheral artery disease (PAD) and a history of failed bypass surgeries, Thomas was running out of options. His treating vascular specialist recommended a minimally invasive endovascular procedure—his last hope to avoid amputation given his documented history of surgical failures.
The insurance company’s response? Denial. The reason? A vascular surgeon who had never examined or even spoken to Thomas reviewed his case and recommended denial of the minimally invasive procedure, suggesting instead an axillary bifemoral bypass—despite Thomas’s extensive history of bypass failures and other surgeons explicitly stating he was not a surgical candidate.
The reviewer’s recommendation ignored critical details in Thomas’s medical history, effectively leaving him with only one path forward: “walk till amputation.”
Thomas’s case illustrates a disturbing reality in America’s healthcare system. In my previous article, I described how the phrase “nothing more we can do” too often means “nothing more we’re willing to try” for PAD patients facing amputation. But there’s an even more troubling dimension to this crisis: even when doctors are willing to try limb-saving procedures, insurance companies increasingly respond with their own devastating message: “Even if you could save this limb, we won’t let you.”
For readers just joining this series, peripheral artery disease (PAD) affects approximately 20 million Americans, gradually restricting blood flow to the limbs. In its advanced stage—critical limb-threatening ischemia (CLI)—patients face imminent limb loss without intervention. As I outlined in Part 1, PAD is increasingly presenting as a “bottoms up” disease, starting in the smallest vessels of the feet, making it more difficult to diagnose and treat with conventional approaches.
This evidence double standard isn’t just a bureaucratic inconsistency—it’s costing Americans their limbs, livelihoods, and often their lives.
The insurance playbook: Four strategies to block limb-saving care
Insurance companies have created systematic barriers to limb-saving interventions while fast-tracking amputation approvals. The result is a healthcare system that often defaults to amputation even when limb preservation might be possible. These companies employ sophisticated strategies that effectively block access to limb-saving care while maintaining plausible deniability about their motivations.
Their playbook consistently follows four key tactics:
Delay: This is perhaps their most effective strategy—postponing care under the guise of pre-authorization requirements. While patients suffer in pain watching their tissue die, insurers create bureaucratic mazes that physicians must navigate. These delays aren’t accidental; they’re calculated to push patients closer to the point where amputation becomes inevitable. By the time approval finally comes through—often weeks or months later—the window for successful intervention has narrowed or closed entirely.
Deny: When delay isn’t enough, insurance companies simply reject procedures outright. They calculate—correctly—that many physicians won’t have the time, resources, or energy to appeal these decisions, especially after previous rounds of paperwork and peer-to-peer reviews. Each denial represents not just an administrative decision but potentially a death sentence for a patient’s limb.
Destroy: Perhaps most disturbing is how these companies systematically undermine the entire limb salvage ecosystem. They employ tactics from dropping physicians who specialize in these procedures from their networks to delaying payments to hospitals and providers who perform them frequently. This financial strangulation may eventually bankrupt healthcare systems or providers unless they comply with insurer-dictated treatment protocols—regardless of what’s best for patients.
Deploy: This final strategy involves creating sets of guidelines based on cherry-picked evidence that supports their predetermined conclusions. They selectively choose research that aligns with their financial interests while ignoring the vast body of evidence supporting interventional approaches. These manufactured guidelines then become the justification for denying care to thousands of patients nationwide.
Of all these tactics, perhaps the most insidious is this manipulation of medical evidence—creating a system where limb-saving procedures face extraordinarily high evidentiary barriers while amputations sail through with minimal scrutiny.
The policy that pushed physicians over the edge
Humana recently provided the most explicit example of how insurance companies are tilting the playing field against limb preservation. I obtained their new coverage policy for peripheral interventions rolled out in early 2024, and the details are deeply troubling for patients with PAD.
This Humana policy, buried in bureaucratic language that most patients would never see, specifically restricts coverage for atherectomy—a precision technique for removing arterial plaque—in smaller vessels below the knee. The justification? “Insufficient evidence” on its effectiveness.
For patients with the increasingly common “bottoms up” pattern of PAD I described in my previous article, this restriction effectively removes one of the most important tools in the limb preservation arsenal precisely where it’s needed most—in the small vessels of the lower leg and foot.
What makes Humana’s policy particularly disturbing is its selective reading of the medical literature. The company claims there is an “absence of current, widely-used treatment guidelines or acceptable clinical literature examining benefit and long-term clinical outcomes” for these procedures.
This statement contradicts the substantial body of evidence that exists. A comprehensive systematic review presented at the 2023 Vascular Interventional Advances (VIVA) conference identified hundreds of original research articles on atherectomy outcomes, including meta-analyses, randomized trials, and multicenter observational studies.
Atherectomy for Lower Limb Revascularization: A Systematic Review and Meta-Analysis, published in the Journal of Endovascular Therapy, demonstrated that atherectomy followed by drug-coated balloon angioplasty reduced amputation risk by 44% compared to drug-coated balloon angioplasty alone—a significant finding for patients with complex below-knee disease.
Yet Humana and other insurers conveniently ignore this substantial body of evidence while selectively citing research that supports their restrictive policies. And Humana isn’t alone—they’re simply the most recent and explicit example of a troubling industry-wide trend.
The research insurance companies used to justify amputation
When insurance companies justify restricting access to limb-saving procedures, they frequently cite retrospective analyses that suggest correlations between certain interventional procedures and subsequent amputations.
This research is valuable and raises important questions about appropriate patient selection. However, insurers have seized on these associations to claim that procedures like atherectomy might actually increase amputation risk—despite the fact that correlation doesn’t prove causation, especially in retrospective analyses that can’t account for all variables.
What’s missing from these policy decisions is context. Researchers themselves acknowledge the limitations of retrospective studies and emphasize that specialized techniques have appropriate applications, particularly for patients facing imminent limb loss.
Yet insurance companies have leveraged selective research interpretations to create barriers for all patients, including those for whom these procedures represent the last hope to save a limb.
The unexamined amputation: No evidence required
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 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.
Even more concerning, approximately 90% occur without a vascular evaluation at all.
Let that sink in: 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, no prior authorization, and no evidence review.
There is no credible medical evidence suggesting that proceeding directly to amputation without attempting revascularization leads to better outcomes. In fact, available data through a study in the Journal of Vascular Surgery [Long-term outcomes of diabetic patients undergoing endovascular infrainguinal interventions] indicates the opposite—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 unsupported by medical evidence.
The contrast is impossible to ignore: insurance companies express concern about interventional procedures potentially leading to amputation in some cases, yet show minimal concern about the vastly more common practice of proceeding directly to amputation without trying any limb-saving measures first.
When “Last chance” options are denied by insurance
Perhaps the most egregious example of this double standard appears in how insurance companies handle innovative “last chance” interventions for patients who have exhausted conventional options.
Deep vein arterialization (DVA) represents one such approach. For patients with no remaining arteries suitable for conventional treatment, DVA creates an alternative pathway for blood to reach the foot by connecting an artery to a vein, effectively bypassing the damaged arterial system entirely.
This technique represents a true innovation in limb salvage—one that could save thousands of limbs each year among patients previously considered “no option” cases.
The clinical evidence is compelling. The PROMISE I early feasibility study demonstrated a 12-month amputation-free survival rate of 76% in patients who would otherwise face certain amputation. The ALPS Multicenter Study showed similarly impressive results, with a 60% amputation-free survival rate at one year among “no-option” CLI patients.
Yet Humana’s policy explicitly denies coverage for DVA, citing—you guessed it—“insufficient evidence.” This is despite their own policy document acknowledging these positive clinical outcomes. For patients who have exhausted all other options, this denial isn’t just a bureaucratic decision—it’s essentially a mandate for amputation.
Humana also restricts other promising “last chance” procedures like intravascular lithotripsy (IVL), which uses acoustic pressure waves to break up calcified plaque that traditional methods can’t treat effectively. Similarly, they restrict percutaneous transmural arterial bypass (PTAB), an FDA-approved procedure designed specifically for long-segment blockages that are difficult to treat with other approaches.
For each of these innovative techniques, Humana applies the same “insufficient evidence” standard while readily approving amputations—which carry significantly higher mortality rates—without requiring any evidence of prior attempts at limb preservation. This directly contradicts established medical guidelines from both the Society for Vascular Surgery and the American Heart Association, which explicitly state that a full vascular evaluation should be performed AND an attempt to restore inline blood flow should be made prior to any amputation. Yet insurance companies continue to automatically approve amputations without requiring any adherence to these clinical practice guidelines.
This is perhaps the clearest example of the double standard in evidence requirements. Insurance companies claim they need overwhelming evidence before covering a procedure that might save a limb, yet require no evidence whatsoever before covering an amputation—despite knowing amputation carries staggering mortality rates.
The mortality reality insurance companies ignore
This selective evidence standard becomes even more troubling when you consider what we know about post-amputation outcomes.
Research from the Journal of Vascular Surgery [Comparative effectiveness of endovascular and surgical revascularization for patients with peripheral artery disease and critical limb ischemia: systematic review of revascularization in critical limb ischemia.] shows that patients undergoing major amputation face mortality rates approaching five times that of the general diabetic population. The one-year mortality rate after major amputation exceeds 40% in many studies, with a startling 48% mortality rate documented in some populations.
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. That’s according to a study in the Journal of Vascular Surgery [High amputation rates among patients with peripheral arterial disease and kidney failure].
These mortality statistics further strengthen the case for attempting limb salvage before proceeding to amputation. Studies consistently demonstrate that patients who receive successful limb-saving procedures have significantly better outcomes, with research [Functional outcomes following revascularization for critical limb ischemia] presented in the Journal of Vascular Surgery showing that the majority 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.
Yet insurance policies increasingly force physicians to proceed directly to amputation without attempting the very procedures that might preserve not just limbs, but lives.
Inconsistent standards across procedures for PAD
The evidence double standard becomes even more apparent when comparing PAD interventions to other medical procedures.
Many widely accepted medical interventions—from coronary stenting in stable angina to spine surgeries for chronic back pain—continue to be routinely covered by insurance despite ongoing debates about their effectiveness in certain populations.
Even experimental cancer treatments often receive coverage under compassionate use provisions when patients have exhausted conventional options. Insurers recognize that in life-threatening situations, patients deserve access to treatments that might help, even if definitive evidence is still evolving.
Yet for PAD patients facing limb loss—a condition with devastating physical, psychological, and economic consequences—insurers apply a standard of evidence that would disqualify many commonly covered procedures in other specialties.
The inconsistency is striking. Insurance companies readily approve procedures with similar or less evidence in other specialties while demanding impossibly high evidence standards for limb-saving interventions.
This inconsistency raises uncomfortable questions about whether certain patient populations are valued differently within our healthcare system.
The human cost of evidence standards for PAD
Behind these abstract discussions of evidence standards are real patients whose lives are permanently altered by these policies.
At the Global PAD Association, I regularly hear from patients who were denied potentially limb-saving procedures only to end up with an amputation that could have been prevented. One patient presented to a hospital with a gangrenous toe. Her vascular specialist recommended using balloon angioplasty and atherectomy to restore blood flow through the small vessels below her knee. The insurance company initially denied the procedure, citing—once again—insufficient evidence.
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.
This story reflects broader patterns confirmed by research. A study in the Journal of the American Heart Association [Disparities in Limb Salvage for Patients With Critical Limb Ischemia: Role of Income and Insurance Status] found that insurance status significantly affects limb salvage rates, with uninsured and Medicaid patients experiencing amputation rates 38% and 48% higher, respectively, than privately insured patients.
These disparities suggest that evidence standards aren’t being applied equally across patient populations—raising troubling questions about equity in our healthcare system.
The importance of true evidence-based policy
If insurance companies truly care about evidence-based medicine, they should apply the same rigorous standards to all procedures—including amputations. This would mean:
- Requiring documented vascular evaluation before approving any lower extremity amputation
- Ensuring patients receive consultation with a vascular specialist trained in advanced limb salvage techniques before proceeding to amputation
- Requiring documentation of why revascularization attempts would not be beneficial before approving primary amputation
- Developing coverage policies through collaboration with specialists actively performing these procedures, not just academic researchers
- Acknowledging the growing body of evidence supporting below-knee interventions rather than selectively citing literature that supports coverage restrictions
We’re not asking for universal approval of any specific procedure. We’re asking for consistent evidence standards that prioritize limb preservation when possible and recognize the devastating consequences of unnecessary amputations.
The way forward: Transparency and accountability
The situation has become so concerning 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 should be required to have their evidence standards and policy-making data reviewed by an independent board, ensuring that coverage decisions aren’t being driven purely by financial considerations.
Congress has previously taken similar action regarding mammography coverage, recognizing that certain preventive care is too important to be subject to inconsistent coverage standards. The same principle should apply to limb-saving procedures.
The fundamental question isn’t whether atherectomy or any specific procedure deserves universal 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 patients, physicians, and policymakers, 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 outcomes.
Because in the battle between evidence standards and patient limbs, there’s no question which should take priority.
The evidence double standard we’ve explored in this article raises a disturbing question: Why would insurers demand gold-standard evidence for limb-saving procedures while requiring none for amputations? The answer, as we’ll see in Part 3 of this series, lies in the economics of amputation. Behind America’s amputation crisis lurks a shocking truth—our healthcare system often makes more money by cutting off limbs than by saving them.
