U.S. health insurance companies historically have never given an tinker's damn about patient lives. In a profit-driven system, their only concern has been maximizing those profits. If a treatment or a patient's condition threatened to cut into those profits, they would simply deny or drop coverage and allow the patient to suffer and die.
The Affordable Care Act has done something to curb those abuses, though insurers are still profit-driven, and maximizing profits are still their primary concern. This would seem to be the case in recent calls from the insurance industry to place tight restrictions on the use of morcellators, a device employed in uterine surgery – specifically, hysterectomies and cyst removal. Unfortunately, these devices have been causing more problems than they solve by spreading pre-cancerous tissues throughout the patient's abdominal cavity.
Cancer, particularly when it spreads, is a very expensive disease – and now that insurers are prohibited by law from denying coverage, they are paying a lot more attention to the morcellator issue. In April 2014, the U.S. Food and Drug Administration (FDA) found that as many as 1 in 350 women diagnosed with cystic fibroids actually have cancerous tumors – and use of the morcellator can spread the malignant tissues. Seven months later, the agency announced that the device should not be used in surgery except as a last resort – and issued an advisory calling for a “black box” warning on the tool.
The FDA stopped short of actually requiring such a warning, however.
The federal regulatory agency approved the first power morcellator in 1991. Over the next twenty years, ten more models were “fast tracked” to approval through a dubious process known as 510(k) Pre-Market Clearance. It allows pharmaceutical and medical device manufacturers to by-pass the normally stringent testing and clinical trials normally required if they can demonstrate that the product is “substantially similar” to one already on the market. More often than not, these products wind up causing injuries and even death, resulting in years of litigation. Some infamous examples include metal-on-metal artificial hips and vaginal meshes. Although the medical device industry and their handmaidens at the FDA continue to defend the process, 510(k) Clearance has been the target of increasing criticism from the medical community – and now, the insurance industry.
Several major insurance carriers now have restrictions on coverage for procedures using a morcellator, deeming them “investigational” - meaning they are considered medically unnecessary and therefore ineligible for reimbursement. Other insurers have stopped coverage for morecellator surgery altogether. They're encountering resistance from the American College of Obstetricians and Gynecologists, however, as well as physicians who believe that insurers are not qualified to make medical decisions.
In vast majority of cases, the physicians would be correct – bean-counters at insurance companies have no medical training and should leave such decisions to trained surgeons. However, in this case, with such overwhelming evidence of the dangers of morcellator surgery, it appears that health insurers are doing the right thing for once – even if their motives are self-serving.
For more information on the power morcellator litigation, please visit Levin Papantonio Morcellator Lawsuit web site.