Affordability and Access: The Barriers to Noninvasive Therapies for Women

Written by Jessica Foley, PhD

Key Points

  • In this blog, the Foundation’s Chief Scientific Officer discusses factors affecting women’s healthcare, using uterine fibroids as a model.
  • Focused ultrasound has been approved to treat fibroids for 20 years, so why aren’t more patients able to receive this noninvasive treatment?
Woman talks to their doctor in an office

A new Congressional resolution has been introduced to formally recognize May as National Menstrual Health Awareness Month. The designation is being supported by leading women’s health organizations, including The Fibroid Foundation and the American College of Obstetricians and Gynecologists (ACOG). The stigma that persists around menstruation impacts many aspects of life for half of the world’s population. At the Foundation, we feel passionately that focused ultrasound can offer women relief from the symptoms of uterine fibroids, the main one of which is debilitating menstruation. However, 20 years after the technology was approved to treat the disease, we have seen little impact on lives.  

What often-debilitating condition affects up to 75 percent of women and has long been ignored in the US healthcare system?  

The answer is uterine fibroids. And while there are minimally invasive fibroid treatment options, most doctors only offer their patients complex, invasive surgical treatments such as hysterectomy or myomectomy that can require up to six weeks of recovery time and end the patient’s fertility forever.  

Yet almost 20 years ago, the US Food and Drug Administration (FDA) approved focused ultrasound as a noninvasive procedure to treat uterine fibroids. The treatment lets women return to work and daily activities in just a few days while leaving fertility undisturbed.  

Since the early 2000s, focused ultrasound has been used to successfully treat over 175,000 fibroid patients globally, including over 25,000* in 2021 alone. During a procedure, the physician uses imaging guidance (ultrasound or MRI) to aim beams of ultrasound energy precisely at the fibroid tumor. Where the beams converge, they heat and destroy the fibroid, leaving surrounding healthy tissue untouched. Complications are rare.  

A 2013 survey published in the  American Journal of Obstetrics and Gynecology and the Journal of Women’s Health reported that when 1,000 US women with fibroids were presented with treatment descriptions, the majority (60%) rated focused ultrasound as their top treatment choice.  

So why is focused ultrasound awareness in the US so low, and why aren’t more physicians talking to their patients about it?  

The answer is simple and disturbing: affordability and access. Few private insurers cover focused ultrasound for fibroids, and Medicare and Medicaid rarely do. Most insurance companies would rather pay for hysterectomies – a “definitive” treatment for fibroids since the uterus is removed. Also, they claim that not enough physicians practice the procedure to warrant covering it. Yet, why would doctors recommend a non-reimbursed treatment to their patients when there are reimbursable options, even though often unnecessarily “invasive”? It’s a catch-22 in which patients always lose.  

The result is that only those who can afford to pay out of pocket can receive focused ultrasound, and usually they must first learn about it – and then find a treatment center – completely on their own. 

Adding to the equation, uterine fibroids disproportionately affect Black women, who already experience more substantial barriers to healthcare. And on average Black women are younger at fibroid onset, have larger and more numerous tumors, experience more severe symptoms, and are more likely to require surgery and hospital stays.  

Expanding access to focused ultrasound would provide an additional treatment option for all women, so that geographic location and socioeconomic status aren’t determining who receives which treatment.  

The personal and societal costs of diminished quality of life, lost work time, and continual healthcare expenditures for all fibroid sufferers are substantial. While some medications can provide symptom relief, they do not treat the fibroids. Surgical options to remove fibroids, such as hysterectomy and myomectomy, require significant downtime that many women simply can’t afford.  An incisionless procedure offers significant benefits, such as markedly decreased recovery times leading to less lost wages, less disruption of normal life activities, and potential cost savings for our health care system.  

So, despite long-standing FDA approval, focused ultrasound remains inaccessible for most women. Blue Cross/Blue Shield, AETNA, and United have all approved cases on an individual basis, but no major US insurance company provides consistent coverage and reimbursement. Medicaid, Medicare, the VA healthcare system, and the Military Health System are no better. Fibroid treatments are a prime example of insurers determining treatment practices despite the expressed needs and best interests of the patient.  

All women should be able to choose a safe, effective, and noninvasive treatment option that ends pain and suffering, allows a quick return to work and normal life, and safeguards their ability to have children. While advocates push for broader coverage from both public and private payers, women everywhere who suffer from fibroids should be aware of focused ultrasound – and then ensure doctors and insurance companies hear their desire for noninvasive options.  

As women, our diverse and persistent voices may be our best tools to bring about equitable and comprehensive treatment for this otherwise frightening and painful condition. 

 Jessica Foley, PhD, is the Chief Scientific Officer and a Managing Director for the Focused Ultrasound Foundation. 

*Based on data from the Foundation’s 2022 State of the Field Report.