Health insurer Aetna announced that effective May 15, 2015, in most circumstances, it will not cover hysterectomies and myomectomies (procedures to remove uterine fibroid tumors) that are performed using a surgical device known as a power morcellator, stating that “the safety and efficacy of this approach has not been demonstrated.” Aetna’s policy change comes in response to a Food and Drug Administration (FDA) safety warning issued in April 2014 about laparoscopic power morcellation and its potential to spread cancer cells throughout the body.
The FDA safety communication states:
If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.
We commend Aetna for making this evidence-based decision that will protect women with rare uterine cancers that are not detected before surgery.
Aetna’s coverage policy change precedes recent news that the FBI is now looking into whether device manufacturers failed to report information about deaths and serious injuries associated with power morcellators to the FDA as required by law. Hayes will continue to monitor the issue and report on any new developments.
Read our earlier blog entitled FDA Addresses Potential Cancer Risk Associated with Laparoscopic Device to learn more about the FDA warning on power morcellation and the FDA approval process for power morcellators.