Part 1 – The Issue
Picture the following scenario:
Your 17-year-old daughter is in her last semester of high school. Last week, the letter came that announced she had been accepted on early decision to her top college choice, Stanford. The family is riding high, and your daughter is now alternating between studying hard and floating on a cloud. This morning at breakfast, she announces that she thinks she might need to go to the doctor because she has a lump in her right breast. When questioned, she says she’s pretty sure she noticed it well before Christmas and perhaps even last summer, but she kept assuming it would just go away. She stresses that she’s been busy with homework, tennis, the yearbook and all of her other activities, and she didn’t pay it much attention. This morning in the shower, however, she realized that it is larger and is now sore to the touch. You keep asking her gentle questions, trying to be sensitive and not freak her out. Inside, you are freaking out. You tell her you’ll make an appointment with the doctor today.
Ten weeks later, a lot of progress has been made, but many questions and issues still remain. A gynecologist has examined her, performed an ultrasound and referred her to an imaging center for a mammogram in preparation for a biopsy. The mammogram confirmed that she had a 1.9mm tumor in her right breast. Two weeks later, she went back for a needle biopsy of the lesion. Her doctor called her three days later to tell her that she had a benign fibroadenoma and suggested she see a breast surgeon to discuss treatment options. You and your daughter immediately start searching the internet to gain more knowledge and look at all possible treatments for this fibroadenoma.
You then both went to the breast surgeon’s office to discuss what happens next. The doctor explained that fibroadenoma is a disease of adolescent girls and women of child-bearing age, that while the lesion is benign and not malignant it will most likely continue to grow, and that women who have a fibroadenoma tend to have multiple tumors develop over their lifetime. In many cases, no treatment is necessary, but most women choose to have their fibroadenomas treated for their comfort and peace of mind. About 75% of women have their fibroadenoma treated within 5 years of diagnosis. The doctor outlined a choice of treatment alternatives:
- Watch and wait – The doctor explained that many women choose to simply watch the tumor, returning to the doctor at 6-month intervals to evaluate the progress of the fibroadenoma. In your daughter’s case, because the site of her lesion is very tender, this would likely not be an option.
- Surgical excision – The next option is to remove the tumor with a surgical procedure. This option would be 100% effective in removing the tumor but would leave a ½-1” scar and may result in a slight dimpling in her breast because of the tissue removal.
- Va cuum-assisted “debulking” – This option would involve placing a vacuum probe through a small incision in her breast and sucking out much of the fibroadenoma in small pieces. The procedure would take 40-60 minutes under local anesthesia, but there is a 30-40% recurrence rate in tumors larger than 1.5mm.
Your daughter brings up a fourth option she read about online, a process called cryoablation, which freezes and destroys the tumor without any tissue removal and with only a 1/8” skin nick instead of a larger scar. She says that she understands the procedure takes 10-15 minutes in a doctor’s office instead of an operating room, needs only local anesthesia, is minimally invasive, and is 100% effective in the destruction of the tumor without removing any breast tissue or changing the shape or appearance of her breast—obviously a higher priority for her. After some discussion with the doctor, she is referred to a doctor who can perform the cryoablation. [In the interests of full disclosure, I should note that my company makes equipment used in cryoablation. But the issue about insurance companies and new technologies is much broader; cryoablation is just an example.]
You both then visited the new doctor and were informed that your daughter was an excellent candidate for cryoablation. You learned that cryoablation unleashes the body’s natural healing process, that it’s been used in other parts of the body for more than two decades, that cryoablation for the breast was developed by a company in California in 2000 and that their systems had successfully been used to treat more than 4,000 cases of breast tumors. You also learned that the procedure had been cleared by the FDA since 2001 for the treatment of fibroadenoma as well as for the treatment of cancerous and malignant tissue, and that the American Society of Breast Surgeons had issued a consensus statement in 2005 that stated, “Several multi-institutional trials have demonstrated cryoablation to be a successful option for the resolution of fibroadenomas without surgical excision. The FDA has approved the use of cryoablation as a safe and effective therapy for fibroadenomas. Results of cryoablation have been followed out to 4 years and demonstrate the procedure to be safe, efficacious and durable.” There has also been a breast cancer trial using the cryoablation system, and results for breast cancer cryoablation treatment would be published next year. The doctor also stated that while your daughter would still be able to feel a palpable lump in her breast for a number of months after the treatment while her body reabsorbed the treated tissue, 69% of cryoablated fibroadenomas ≤ 2 cm were non-palpable within 6 months and nearly all would resolve within 2 1/2 years, with a 97% patient satisfaction rate. You are both convinced that this sounds like the treatment of choice.
You stopped at the front desk to make sure the doctor’s office has all the necessary insurance information. You were told that they would have to get a pre-authorization. Your daughter is leaving for college in five weeks, so time is of the essence. Then the waiting began; a week later you called the doctor, but no approval yet.
On day 13, you feel like you stepped into the Twilight Zone. You receive a call from the doctor’s office telling you your insurer has denied coverage for the cryoablation. When, in disbelief, you ask why, you are told that the insurer considers the procedure “investigational.” You immediately call your insurer, who politely repeats the investigational mantra, and talking to the supervisor gets you no further. You call the doctor’s office and are told that you could appeal the denial with the insurance company and with an Independent Medical Review, or pay cash for the treatment. Because all of the family’s cash is going into the college fund, paying cash is not an option.
You are both left questioning why a safe and effective, minimally invasive treatment wouldn’t immediately be embraced by the insurance company. You head back to the internet and find that United Healthcare, some of the Blue Cross plans and numerous smaller insurers around the U.S. had been covering the procedure for nearly eight years, but your insurance plan does not. You are blowing a gasket at this point. You could change plans but not in time to get the cryoablation treatment before your daughter left for college. You could choose another treatment option, but she has her heart set on preserving the look and shape of her breast. Why, you wonder, if women can get free birth control pills and men can get Viagra covered by all insurers, why couldn’t you get a breast-saving procedure for your daughter paid by your healthcare insurer?
It just doesn’t make sense. Finally, in anger and disgust, you write a letter to your insurer protesting the denial of coverage and resolve to follow the path of Independent Medical Review to get the denial overturned. Your daughter leaves for college with the increasingly painful fibroadenoma untreated.
Unfortunately, this scenario and many more like it play out in the U.S far too frequently. In the U.S., 700,000 cases of benign fibroadenoma are diagnosed annually. These fibroadenomas will continue to grow, are frequently unsightly, and often cause pain and considerable emotional trauma and suffering for the affected women. More than 500,000 cases are treated within five years, often at a larger size and with more physical damage and disruption to the breast. Cryoablation is FDA 510k-cleared and has been a safe and effective treatment for more than a dozen years, yet many health insurers continue to deny their insureds a superior treatment option for a frequently disfiguring disease. One wonders why? Why are many insurance companies so slow to adopt new technologies?
NEXT: This is the first of a 3-part series. Next, we will look at the technology and treatment process, and Part 3 will examine the economics of various treatment options.