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Morcellation Media Monitoring 3/2/2015
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UnitedHealth places tighter controls on hysterectomies
Mar 26, 2015 | Reuters
By Deena Beasley
UnitedHealth Group Inc, the largest health insurer in the United States, is placing tighter controls on its coverage of hysterectomies after a device called a morcellator was linked to the spread of undiagnosed cancer cells. -
UnitedHealth Restricts Use of Nonvaginal Hysterectomies
Feb 27, 2015 | MedScape
By Robert Lowes
Giant insurer UnitedHealthcare will require prior authorization for all hysterectomies except those performed vaginally on an outpatient basis beginning April 6. -
Largest US insurer tightens hysterectomy guidelines amid cancer fears
Feb 27, 2015 | Al Jazeera
The U.S.’s largest health insurer has announced it is to place stricter controls on its coverage of hysterectomies amid ongoing concerns that a once popular device used in laparoscopic surgeries can spread undetected cancer. -
Largest Health Insurance Company Announces New Rules For Hysterectomy Coverage
Feb 27, 2015 | Tech Times
By Sumit Passary
UnitedHealth Group, which is the largest health insurance company in the U.S., has announced new rules for hysterectomy coverage. -
UnitedHealth puts restrictions on hysterectomies
Feb 27, 2015 | Minneapolis/St. Paul Business Journal
By Mark Reilly
UnitedHealthcare, the nation's largest health insurer, is telling doctors to get clearance before performing most hysterectomies, saying it is concerned about the dangers of a tool used in the procedures. -
UnitedHealth Group becomes tough on hysterectomies
Feb 27, 2015 | News Maine
By Daria Morozova
UnitedHealth Group Inc, a health care company headquartered in Minnetonka, Minnesota, US, is toughening controls on its coverage of hysterectomies. The company has taken this decision following the association of a device called a morcellator with the spread of undiagnosed cancer cells. -
UnitedHealth limits coverage for most popular hysterectomies
Feb 27, 2015 | KSAT News
By Chris Isidore
The nation's largest insurer is putting sharp limits on the most common form of hysterectomies, saying the procedure poses a health threat and that a different form of the surgery has been found to be safer.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
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UnitedHealth places tighter controls on hysterectomies
Mar 26, 2015 | Reuters
By Deena Beasley
UnitedHealth Group Inc, the largest health insurer in the United States, is placing tighter controls on its coverage of hysterectomies after a device called a morcellator was linked to the spread of undiagnosed cancer cells.
In an update to its reimbursement guidelines, UnitedHealth said that, starting April 6, it will require physicians to obtain authorization before carrying out certain types of hysterectomies, a procedure in which a woman's uterus is removed for reasons ranging from fibroids or endometriosis to chronic pelvic pain.
UnitedHealth said it will not require prior authorization for vaginal hysterectomies, in which the uterus is removed through the vagina, when done on an outpatient basis.
In its update, the insurer cites the American Congress of Obstetricians and Gynecologists as identifying vaginal hysterectomies as the preferred method.
The Food and Drug Administration issued an advisory nearly a year ago recommending that surgeons avoid the use of surgical morcellators in performing hysterectomies because of evidence the technique could spread cancerous tissue. Morcellators are devices used in laparoscopic surgery to cut up tissue so that it can be removed through small incision sites.
The FDA said a vaginal hysterectomy usually yields comparable or better results with fewer complications than laparoscopic or abdominal hysterectomies.
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UnitedHealth Restricts Use of Nonvaginal Hysterectomies
Feb 27, 2015 | MedScape
By Robert Lowes
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 toMedscape 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 Newslast 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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Largest US insurer tightens hysterectomy guidelines amid cancer fears
Feb 27, 2015 | Al Jazeera
The U.S.’s largest health insurer has announced it is to place stricter controls on its coverage of hysterectomies amid ongoing concerns that a once popular device used in laparoscopic surgeries can spread undetected cancer.
UnitedHealth Group said that from April 6, it would require physicians to obtain authorization before carrying out certain types of the procedure, namely laparoscopic “keyhole” surgeries and the removal of the uterus via the abdomen. These types of hysterectomies will not be approved unless deemed to be medically necessary, the insurer said in an update to its reimbursement guidelines.
The company, which provides health coverage for 70 million Americans, said its new stance was based on recommendations from the American Congress of Obstetricians and Gynecologists (ACOG), which concluded that vaginal hysterectomies should be favored over other types of the procedure as they are associated with better outcomes and fewer complications. It also comes amid concerns over the link between a surgical tool used in laparoscopic surgery and the spread of cancerous tissue.
A hysterectomy is a procedure in which a woman's uterus is removed for reasons ranging from fibroids or endometriosis to chronic pelvic pain, and is one of the most frequently performed surgeries in the U.S. Based on reports from the early 2000s, the U.S. Centers for Disease Control say around 600,000 hysterectomies are performed every year in the U.S.
The uterus can be removed through the vagina or abdomen, the later being associated with a larger incision and longer recovery time.
Surgeons sometimes use laparoscopic tools to allow for a less invasive operation that involves only a few small incisions. The move in UnitedHealth’s policy comes after research suggested a link between laparoscopic morcellators — once popular devices used in keyhole surgeries to cut up tissue — and cancer.
Scientists have said that the surgical devices can leave behind bits of undiagnosed malignant tissue that grow into new tumors.
The U.S. Food and Drug Administration (FDA) issued an advisory last April recommending that surgeons avoid the use of surgical morcellators in hysterectomies as a result of evidence that the technique could spread cancerous tissue. It issued a stronger warning in November, saying morcellators should not be used in the “vast majority” of cases.
The ACOG has likewise warned against their use, suggesting the device should not be a first or even second choice for most women. The group said vaginal operations allow women to leave the hospital just as quickly and don't cost nearly as much.
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Largest Health Insurance Company Announces New Rules For Hysterectomy Coverage
Feb 27, 2015 | Tech Times
By Sumit Passary
UnitedHealth Group, which is the largest health insurance company in the U.S., has announced new rules for hysterectomy coverage.
Hysterectomy involves surgical removal of the uterus and may sometimes also involve removal of the fallopian tubes, cervix and ovaries. Around 500,000 hysterectomies are performed each year in the U.S., which makes the medical procedure one of the most common amongst U.S. women. The reasons for hysterectomies range from fibroids, pelvic pain or endometriosis.
Recently, UnitedHealth announced tighter coverage rules for hysterectomies procedures. The health insurers reveal that from Apr. 6 this year, healthcare professionals and facilities will have to inform the company in advance before performing certain hysterectomies. UnitedHealth has also revealed that it will not approve the procedure if believed medically unnecessary.
Market observers believe that UnitedHealth's tighter coverage rules are mainly a result of the problems that arise from a tool called laparoscopic power morcellators, which is often used for hysterectomies. The device was previously linked for the spread of undiagnosed cancer cells in patients.
In April 2014, the U.S. Food and Drug Administration (FDA) also released a statement that discouraged the use of morcellators for a hysterectomy procedure.
"The FDA's primary concern as we consider the continued use of these devices is the safety and well-being of patients," said William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health. "There is no reliable way to determine if a uterine fibroid is cancerous prior to removal."
FDA also suggested that patients should discuss the benefits and the risks involved with the use of morcellators for hysterectomies with their doctors.
UnitedHealth also revealed that the new coverage rules do not apply to vaginal hysterectomies, a procedure when the uterus is removed via the vagina. Vaginal hysterectomies are normally conducted on an outpatient basis.
The FDA also recommends vaginal hysterectomy in comparison to abdominal or laparoscopic hysterectomies. The FDA suggests that vaginal hysterectomy involves fewer complications and also yields better results.
However, many doctors prefer laparoscopic, which is less invasive and requires a small incision in comparison to abdominal hysterectomies. The recovery time following an abdominal hysterectomy is longer when compared to laparoscopic hysterectomies.
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UnitedHealth puts restrictions on hysterectomies
Feb 27, 2015 | Minneapolis/St. Paul Business Journal
By Mark Reilly
UnitedHealthcare, the nation's largest health insurer, is telling doctors to get clearance before performing most hysterectomies, saying it is concerned about the dangers of a tool used in the procedures.
The Wall Street Journal reports on the new policy from the insurer, a unit of Minnetonka-based UnitedHealth Group Inc. (NYSE: UNH), which could mean big changes in women's health care. Hysterectomies are one of the most common surgeries for women, with 500,000 procedures performed each year.
It follows a long debate over the safety of laparoscopic power morcellator, which was commonly used to cut up and remove fibrous growths in the abdomen during hysterectomies. But the Food and Drug Administration has said that the fibrous tissue is hard to distinguish from cancerous growths, and chopping it up could spread malignancy. The Wall Street Journa l had first raised concerns about the procedure in 2013.
In its letter to doctors, UnitedHealth is telling doctors that vaginal hysterectomies — which remove the uterus without abdominal surgery — won't need authorization. Vaginal hysterectomies are also less expensive, but are rarely performed because many doctors aren't trained to do it.
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UnitedHealth Group becomes tough on hysterectomies
Feb 27, 2015 | News Maine
By Daria Morozova
UnitedHealth Group Inc, a health care company headquartered in Minnetonka, Minnesota, US, is toughening controls on its coverage of hysterectomies. The company has taken this decision following the association of a device called a morcellator with the spread of undiagnosed cancer cells.
UnitedHealth said that from April 6, doctors will have to get permission prior to performing certain types of hysterectomies. This procedure involves removal of a woman's uterus due to different reasons such as endometriosis and chronic pelvic pain.
According to the healthcare company, prior authorization will not be needed for vaginal hysterectomies. In vaginal hysterectomies, the uterus is removed through the vagina, when it is performed on an outpatient basis.
Catherine Matthews, a University of North Carolina gynecologic surgeon and board member for the American Urogynecologic Society, provides training to doctors in hysterectomy techniques. She said that gynecologists usually provide inadequate instruction on vaginal procedures and the latest decision could help improve training.
"It is a concern about precedent that an insurance company will be dictating mode of access without knowing all the details about the case, but at the heart of the matter, it's interesting that an insurance company may be driving evidence-based medicine", she said.
An advisory was released by the Food and Drug Administration about a year ago. In the advisory the agency recommended that physicians should avoid using surgical morcellators while performing hysterectomies due to evidence that this could spread cancerous tissue. Morcellators are used in laparoscopic surgery for cutting up tissue in order that it can be taken out through small incision sites.
According to FDA, a vaginal hysterectomy often gives better results and there are fewer complications associated with it.
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UnitedHealth limits coverage for most popular hysterectomies
Feb 27, 2015 | KSAT News
By Chris Isidore
The nation's largest insurer is putting sharp limits on the most common form of hysterectomies, saying the procedure poses a health threat and that a different form of the surgery has been found to be safer.
UnitedHealthcare has sent out a bulletin to physicians saying that it will start denying coverage for laparoscopic or abdominal hysterectomies in April unless the doctor gets pre-authorization.
The insurer says it believes vaginal hysterectomies, which account for only 22% of the more than 500,000 hysterectomies a year, are the preferred form and will not require pre-authorization.
The insurer cited the finding of the American Congress of Obstetricians and Gynecologists that "evidence demonstrates that, in general, vaginal hysterectomy is associated with better outcomes and fewer complications than laparoscopic or abdominal hysterectomies."
The Food and Drug Administration has also warned against the laparoscopic or abdominal hysterectomies.
The FDA said the device used in those procedures, the laparoscopic power morcellators, risks "spreading unsuspected cancer" even in women who are having non-cancerous fibroid tissue removed, let alone those who are having the procedure in an effort to remove the cancer.
The FDA and the College of Obstetricians and Gynecologists acted after a story and an e-book by the Wall Street Journal, which called public attention the risks posed by the morcellators.
United Healthcare's notice said physicians who do not get preauthorization for the procedure will have their claim for compensation denied. It said the doctors will not be allowed to bill their patients for the procedure.
That will essentially stop physicians from performing the procedure for most of the more than 40 million female members covered by the insurer, since their inability to bill those patients will mean they can't even pay out of pocket for the procedure.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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