The nation's largest insurer may be setting a precedent with restrictions on a risky, though recently popular approach to the most common gynecological surgical procedure.
Starting in April, UnitedHealthcare will require a prior authorization before its members can receive most kinds of hysterectomies, after a new body of evidence suggesting that laparoscopic power morcellation to remove benign uterine fibroids can actually spread hidden cancerous tissue.
In the recent past, power morcellators became a popular way for women to have the benign fibroids removed laparoscopically, rather than having a vaginal surgery. But in the past two years, it it became clear that morcellation posed its own risks if the women happened to have cancerous tissue such as uterine sarcomas, which can't be found prior to surgery but can end up being spread by the morcellator.
Last spring, that risk became widely acknowledged after Amy Reed, MD, a 40-year-old anesthesiologist in Boston, was diagnosed with leiomyosarcoma, a malignant cancer that may have been driven by an earlier morcellator fibroid removal. Reed and her cardiologist husband launched a campaign to raise awareness of the risks, garnering attention in the Wall Street Journal and eventually the broader public.
Last fall, the Food and Drug Administration released a new warning and an estimate that one in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids has an unsuspected uterine sarcoma (including leiomyosarcoma) that can spread after laparoscopic power morcellation. The agency "discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids," especially in women with suspected or known uterine cancer.
Now, numerous law firms are planning class action cases in women who also have been diagnosed with cancer following a morcellator hysterectomy, many hospitals have pulled back, and insurers may be mulling changes in coverage rules
UnitedHealthcare cites the FDA warning in its new hysterectomy prior authorization policy, which is required for all but vaginal hysterectomies performed in outpatient clinics. The insurer also cited the American College of Obstetrics and Gynecology, which has said that "in general, vaginal hysterectomy is associated with better outcomes and fewer complications than laparoscopic or abdominal hysterectomies."
Vaginal hysterectomy, though, is used in only about 20 percent of the 500,000 hysterectomies performed each year, making UnitedHealthcare's policy a potential incentive to increase the older, cheaper method--and maybe spurring other insurers to adopt similar guidelines.
The nation's second largest insurer, Anthem, also has currently has a hysterectomy prior authorization, although Aetna and Cigna do not, according to the Wall Street Journal's analysis.
The problem is many ob-gyn surgeons may not be all that familiar with gold standard hysterectomy United's policy will be encouraging. "We've developed a generation of surgeons who don't know how to do vaginal surgery, quite frankly," as Neil Finkler, MD, the CMO at Florida Hospital Orlando, told the WSJ.
The American College of Obstetricians and Gynecologists also argues that morcellation needs to remain as an option. "Power morcellation can make it possible for some women to undergo less-invasive laparoscopic hysterectomy or myomectomy, sparing them the longer recovery time and higher mortality rates associated with a total abdominal procedure," said Hal Lawrence, MD, CEO of the ACOG.
"The FDA's clarification of contraindications for morcellation will help to ensure that only women at low risk for an occult malignancy will undergo laparoscopic hysterectomy or myomectomy with morcellation."