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The nation’s largest health insurance provider has issued new rules that are likely to restrict coverage for non-vaginal hysterectomy procedures, due to concerns about the risk of aggressive cancers being spread by power morcellators used during laparoscopic surgery for uterine fibroid removal.
UnitedHealth Group Inc issued a network bulletin to its members recently, which warns that prior authorization from the insurer will be required for any type of non-vaginal hysterectomy, or the procedure will not be covered. The authorization requirement begins in April.
Healthcare experts see the move as a way for the insurer to make sure that doctors only use power morcellation on its members in very limited circumstances, if at all.
“A clinical denial will be issued, and a prior authorization number will not be issued, if it is determined during the clinical coverage review process that the service does not need medical necessity criteria,” the notice warns. “The member cannot be billed for services we determined to be medically unnecessary unless the member, with the knowledge of our determination, agrees in writing to be responsible for the cost of the services.”
Power morcellators are medical devices used during laparoscopic hysterectomy procedures, allowing the surgeon to cut up the uterus and remove the tissue through a small incision in the abdomen. While the device provides a less invasive procedure, which is designed to reduce recovery time and the risk of complications, the devices have been tied to a risk of spreading cancerous tissue throughout the body.
For some women with unsuspected sarcoma, which is hidden cancer that doctors are unable to detect before the procedure, the use of power morcellators during a hysterectomy may rapidly disseminate the cancer to the most advanced and difficult to treat stage.
The new UnitedHealth policy will go into effect one year after the FDA issued a warning urging doctors avoid use of power morcellators during laparoscopic hysterectomy procedures, indicating that about one out of every 350 women with uterine fibroids may have the undiagnosed uterine cancer, such as uterine sarcoma or leiomyosarcoma.
An FDA advisory panel was convened over the summer to evaluate the available data on the controversial devices, which resulted in a determination that there is no way to make power morcellators safer. However, the panel was split on whether to recommend morcellators be recalled or that stronger warnings be placed on the devices.
In a widely criticized move, the FDA announced in November that it will allow hysterectomy morcellators to remain on the market with substantially stronger warnings about the risk of cancer and more limited indications for appropriate use of the devices.
Many hospitals and a growing number of insurance companies have already announced that they will no longer perform or cover a hysterectomy with morcellation, and many experts agree that the vast number of prior procedures performed involving the device are no longer appropriate.
Over the past year, many women and families nationwide have filed laparoscopic hysterectomy cancer lawsuits against the manufacturers of these devices, alleging that inadequate warnings have been provided for patients and the medical community for years.
Plaintiffs allege that the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers may have been avoided if any number of different alternative treatment options available for women with symptomatic uterine fibroids had been used, including traditional surgical hysterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.