UnitedHealth Restricts Use of Nonvaginal Hysterectomies

February 27, 2015

Giant insurer UnitedHealthcare will require prior authorization for all hysterectomies except those performed vaginally on an outpatient basis beginning April 6.

By creating this restriction, the insurer has joined the backlash against the use of laparoscopic power morcellators that have been shown to disperse undiagnosed uterine cancer in abdominal cavities. The devices shred tissues so they can be removed piecemeal through laparoscopic incisions.

In its January 2015 bulletin to network providers, the insurer said that the American College of Obstetricians and Gynecologists "has identified the preferred method for hysterectomies to be vaginal." It quoted the college as stating that "evidence demonstrates that in general, vaginal hysterectomy is associated with better outcomes and fewer complications than laparoscopic or abdominal hysterectomies."

The need for prior authorization extends to abdominal and laparoscopic hysterectomies, and vaginal procedures performed with a laparoscope. Without a prior authorization, UnitedHealth will automatically deny a claim for reimbursement.

When clinicians do request authorization, the insurer will issue a clinical denial if it is determined...that the service does not meet medical necessity criteria."

"We consistently review our guidelines to make sure we are following evidence-based medical guidelines," said UnitedHealth spokesperson Tracey Lempner in an email to Medscape Medical News. Lempner added that warnings about power morcellators from the US Food and Drug Administration (FDA) in 2014 "further compelled us to take action in support of our members."

Taking Their Cue from the FDA

The announcement by UnitedHealth is the latest example of how laparoscopic power morcellation is falling out of favor. In April 2014, the FDA recommended that surgeons no longer use these devices for hysterectomy or myomectomy in most women with uterine fibroids because of the risk of dispersing occult cancer. The agency estimated that 1 in 350 women undergoing the procedures to remove fibroids has an unsuspected uterine sarcoma such as leiomyosarcoma.

Seven months later, the agency toughened its warning by saying that power morcellation is contraindicated for removing uterine tissue with suspected fibroids in patients who are perimenopausal or postmenopausal or in those who are candidates for removing tissue intact through the vagina or a minilaparotomy incision. The devices also should not be used in gynecologic procedures to shred tissue either known or suspected to contain cancer.

Various segments of the healthcare industry responded to the government's guidance in domino fashion last year. Johnson & Johnson's Ethicon division announced it was pulling its morcellators from the market because of cancer "uncertainty." Highmark, a health insurer in the Eastern United States, stopped paying for laparoscopic power morcellation in gynecologic procedures. And HCA Holdings, the largest for-profit hospital chain in the nation, banned the use of power morcellators at its facilities for removing uterine fibroids.

Meanwhile, recent research also has underlined the cancer risk of the technology. A retrospective review published online in the American Journal of Obstetrics and Gynecology in December 2014, for example, showed that 0.6% of women who underwent laparoscopic hysterectomy with power morcellation were later diagnosed with uterine sarcoma.

Power morcellation came under intense scrutiny after a high-profile case in late 2013 involving anesthesiologist Amy Reed, MD, PhD, who underwent a hysterectomy for uterine fibroids at Brigham and Women's Hospital in Boston, Massachusetts. Her surgeon used a power morcellator to shred her fibroids, thought to be benign, for easy laparoscopic removal.

A week later, Dr Reed's physicians told her that she had an aggressive uterine leiomyosarcoma, and that morcellation may have spread the previously unknown cancer throughout her abdomen, according to her husband, cardiothoracic surgeon Hooman Noorchashm, MD. A subsequent operation confirmed that morcellation had advanced the cancer to stage IV, Dr Noorchashm told Medscape Medical News last summer. Since Dr Reed was first diagnosed with cancer, he has waged a relentless public campaign to have the FDA ban the use of power morcellators in gynecologic procedures.

In an interview today with Medscape Medical News, Dr Noorchashm said his wife, a mother of six, has recovered well enough after chemotherapy to return to work recently on a part-time basis.

He called the decision by UnitedHealth to subject laparoscopic hysterectomies to preauthorization "fascinating."

"You have [the gynecologic] specialty basically defending morcellation," said Dr Noorchashm. "The FDA is incapable of doing the correct thing and removing the product from the market. But the insurance industry has looked at the math and the risk statistics and said, 'This is unacceptable.' Where government and the healthcare industry have failed, a third industry has come in and regulated both.

"[UnitedHealth] decided that the cost will be too great and risk to patients too high. These people don't come in and randomly shut things down."


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