Insurers raise questions about medical device approval process
Insurers have raised concerns about the regulation and approval process of medical devices in the wake of a recent advisory notice issued by the FDA on the risks of laparoscopic power morcellators.
A recent advisory notice issued by the U.S. Food and Drug Administration (FDA) on the risks of laparoscopic power morcellators is raising concerns about the regulation and approval process of medical devices.
In addition to industry concern, the Wall Street Journal reported in late May that the Federal Bureau of Investigation (FBI) is investigating whether providers and medical device makers broke the law by failing to report problems linked to morcellator use.
In November 2014, FDA issued a notice that laparoscopic power morcellators could spread previously undetected cancers in women undergoing hysterectomy for the treatment of fibroids. The notice followed growing questions about the safety of the devices voiced by the medical community and insurance industry.
Shortly after, United-Healthcare began requiring prior authorization for certain hysterectomy procedures.
Marc Sanchez, an attorney for Contract In-House Counsel and Consultants, LLC, a boutique law firm focused on FDA and U.S. Department of Agriculture regulation, says it is not surprising that health insurers are speaking up about device safety concerns. “When the risks that become associated with a device are so severe that it outweighs the benefits of using it, insurance companies know its use will lead to greater costs down the road,” he says. “Based on what we have seen for this particular device, that seems to be the case.”
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