Aetna Won't Pay for Most Fibroid Removal Using Morcellators

May 06, 2015

Health insurer Aetna will no longer cover most hysterectomies and myomectomies that utilize power morcellators to remove uterine fibroid tumors "because     the safety and efficacy of this approach has not been demonstrated," the company said yesterday.

The new policy, which takes effect May 15, is the latest backlash against a medical device in the toolbox of gynecologic surgeons that they once took for     granted.

Power morcellators shred uterine tissue into pieces for easier removal, typically through laparoscopic incisions.

Aetna spokesperson Cynthia Michener told Medscape Medical News that the company based its decision in part on a recommendation last year by the US     Food and Drug Administration (FDA) that physicians should stop using power morcellators for hysterectomies and myomectomies to remove fibroid tumors in     most women because they can disperse undiagnosed uterine cancer. The agency later that year ordered a boxed warning for the devices.

Michener said that the company's decision also factored in guidance from medical societies such as the American College of Obstetricians and Gynecologists.

Physicians can request an exception to the coverage ban if the patient is premenopausal and wants to maintain her fertility, and if another treatment would     not be effective. Likewise, Aetna may cover a procedure using a power morcellator for patients with severe comorbidities whose risk for death or severe     morbidity posed by an alternative procedure would outweigh the risk for an undetected sarcoma, put by the FDA at one in 350 women undergoing morcellation.

In addition, physicians now must precertify all hysterectomies and myomectomies that involve power morcellation with the insurer. Michener said the     rationale for this requirement is that insurance claims for these operations don't indicate whether the surgeon used a power morcellator.

Couple Campaigning Against Morcellators to Receive Award

Power morcellators have been under intense scrutiny since the well-publicized case of anesthesiologist Amy Reed, MD, PhD, who underwent a hysterectomy at    Brigham and Women's Hospital in Boston, Massachusetts, for fibroid removal in October 2013. Dr Reed, a mother of six, then discovered that power     morcellation had dispersed an occult uterine leiomyosarcoma. She and her husband, cardiothoracic surgeon Hooman Noorchashm, MD, PhD, have asked gynecologic     surgeons to stop using the devices, and the FDA to ban them.

The FDA's warnings last year triggered a widescale retreat from tissue morcellation. Johnson & Johnson voluntarily withdrew its morcellators from the market     because of cancer "uncertainty." The hospital chain HCA Holdings prohibited their use at its facilities for removing uterine fibroids. Highmark, a health     insurer in the eastern United States, stopped paying for laparoscopic power morcellation in gynecologic procedures. And in February 2015, UnitedHealthcare     announced that, in light of     the FDA's actions, it would require preauthorization for all hysterectomies other than vaginal procedures performed on an outpatient basis.

"There has been a major reduction in the use of laparoscopic power morcellators in today's market," the head of America's Health Insurance Plans (AHIP), a trade group, reported to Sen. Robert Casey Jr (D-PA), in a recent letter.

The AHIP letter sought tighter processes for approving all medical devices and monitoring their safety in light of the morcellation issue. Dr Reed and Dr     Noorchashm are lobbying members of Congress to hold a hearing on this matter.

Dr Noorchashm, the point person in the couple's campaign, thanked Aetna in an email for its decision to limit coverage of procedures involving     morcellators.

However, he told Medscape Medical News that the insurer had "fallen short" by making coverage exceptions instead of banning payment for any and     all morcellator-related procedures. He noted that Aetna's decision came a little over a month after he had emailed its executives saying that their     continued coverage of these procedures was an "act of corporate irresponsibility."

"You can judge for yourself if these were linked," he said.

This Friday, Dr Noorchashm and his wife, who live in the Philadelphia area, will be honored by the National Center for Health Research (NCHR), an advocacy     group that focuses on women, children, and families. The couple will receive the NCHR's Health Policy Heroes award for their efforts to ban the use of     power morcellators.

Dr Reed is recovering from her second cancer surgery and preparing to return to work next month at the Hospital of the University of Pennsylvania,     according to Dr Noorchashm.

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