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US health insurers covering around about 93 million Americans are moving to restrict laparoscopic power morcellators (LPMs) amid recent concerns that use of the devices may inadvertently spread cancer in some women, reported The Wall Street Journal. Last April, the FDA warned against using LPMs during hysterectomy or myomectomy in women with uterine fibroids due to the risk of spreading undiagnosed gynaecologic malignancies within the abdominal cavity, and later recommended that manufacturers update product labelling to include a boxed warning to that effect.
Johnson & Johnson, which was the largest morcellator manufacturer, moved to implement a global market withdrawal of the products in 2014, although other LPMs remain available and insurers are influencing how much the tools are still used, according to the report. Karen Ignagni, chief executive of America's Health Insurance Plans, noted that "plans are looking very seriously at this." The group is in the process of compiling insurer actions at the request of a US lawmaker, who has asked for details about how insurance companies were dealing with the risk from LPMs.
Earlier this year, UnitedHealth Group said it will implement a policy as of April 6 requiring that physicians obtain prior authorisation from the insurer for all hysterectomies except outpatient vaginal procedures, which do not require morcellators. Health Care Service recently proposed labeling power morcellation as "not medically necessary," while Aetna is exploring changes in its coverage of the device. Cynthia Michener, a spokesperson for Aetna, said its review should be completed later this month with a new policy that is consistent with the FDA's most recent warning.
Meanwhile, Blue Shield of California in November classified power morcellation for fibroids as "investigational," which typically indicates the procedure will not be covered in most cases. However, Cigna spokesman Mark Slitt noted that "while there are risks to using power morcellation, there are also risks to stopping as some women need a less invasive procedure for hysterectomy." He added that Cigna is monitoring medical literature to determine if a policy change is warranted.
Earlier this year, two published studies further questioned the use of LPMs. However, study data published last month in the American Journal of Obstetrics & Gynecology suggested laparoscopic hysterectomy with morcellation may be safer than abdominal surgery in certain women being treated for presumed uterine fibroids.
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