Aetna has joined the ranks of insurers sharply restricting use of morcellators, a technology that has come under fire from the Food and Drug Administration (FDA) because of concern about the potential for seeding of uterine sarcomas undetected during laparoscopic hysterectomy.
In a policy statement issued on May 5, Aetna said that “myomectomy and hysterectomy procedures that use a power morcellator will not be covered in most circumstances because the safety and efficacy of this approach has not been demonstrated.” As of May 15, precertification will be required for any myomectomies or hysterectomies performed with the device.
A “clinical exception” to the new policy can be requested for premenopausal patients who want to maintain their fertility and for whom another surgical procedure would not be effective and/or women with severe comoribidities where risk of death or severe morbidity with another procedure outweighs the risk of an undiagnosed sarcoma.
The tightening of controls by Aetna—the country’s third largest health insurer—comes in the wake of a warning from the FDA in November 2014 about the use of morcellators during laparoscopic hysterectomies. The FDA estimates that approximately 1 in 350 women undergoing hysterectomy or myomectomy for treatment of fibroids has an unsuspected uterine sarcoma. In April, the country’s largest insurer, UnitedHealthCare, began requiring prior authorization for abdominal laparoscopic, vaginal, and laparoscopic-assisted vaginal hysterectomy. Morcellation is not performed during vaginal hysterectomy and the UnitedHealthCare restriction does not apply to outpatient vaginal surgeries.
According to a report in The Wall Street Journal, to date, “health plans covering 93 million Americans have either curtailed use of morcellators or are considering limits.” As noted in that report, the FDA has not banned morcellators but the largest manufacturer, J&J, is no longer selling the devices.