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Morcellation Media Monitoring 3/12/2015
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A remarkable paradigm of free-market self-regulation: UnitedHealth regulates gynecologists
Mar 9, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm, MD, PhD, and Amy J. Reed, MD, PhD
The recent move by UnitedHealth was triggered by our yearlong campaign to enforce a ban on a widely used gynecological practice, known as morcellation. Because for over 2 decades, minimally invasive gynecologists across the world, had been spreading and upstaging unsuspected and deadly cancers by using this practice. Out of the Hundreds and thousands of women undergoing uterine resection for symptomatic fibroids annually worldwide, somewhere around one out of every 150-350 were falling victim to a deadly hazard. -
UnitedHealth to require special OK for most inpatient hysterectomies
Mar 12, 2015 | St. Louis Post-Dispatch
By Danielle Paquette
UnitedHealth, the country’s largest insurer, will soon require doctors to get permission before performing most types of inpatient hysterectomies, a procedure in which the uterus is removed, often to prevent or treat cancer. -
Morcellation Foe Presses On Despite Return of Cancer
Mar 10, 2015 | MedScape
By Robert Lowes
Amy Reed, MD, PhD, nevertheless comes across as nothing but resilient. The anesthesiologist whose occult uterine cancer was upstaged as a result of laparoscopic power morcellation during a hysterectomy remains a staunch patient-safety advocate despite the recent return of her disease. Her high-profile case already has spurred a retreat from the use of the tissue-shredding devices, abetted by strong warnings from the US Food and Drug Administration (FDA) about the risk of dispersing occult cancer in abdominal cavities. However, she and her husband, Hooman Noorchashm, MD, PhD, hope to persuade gynecologic surgeons to abandon the technology entirely. -
Women’s Health Devices Taken to Task by Citizen Petitions
Mar 9, 2015 | Medical Device And Diagnostic Industry
By Marie Thibault
Recent citizen petition letters find fault with two female health devices—the laparoscopic power morcellator and a permanent birth control insert. Both devices have been the subject of recent heated debate and the petitioners lobby for FDA to yank them from the market. -
UnitedHealth decision sparks debate over payers as 'watchdogs'
Mar 11, 2015 | Health Care Dive
By Heather Caspi
UnitedHealth's recent decision to require special approval for certain types of inpatient hysterectomies, citing medical evidence, has raised eyebrows in the medical community over the insurer expanding its role in medical decision-making.
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A remarkable paradigm of free-market self-regulation: UnitedHealth regulates gynecologists
Mar 9, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm, MD, PhD, and Amy J. Reed, MD, PhD
Recently, UnitedHealth the largest health insurer in the United States made a very dramatic move. This insurance provider joined a chorus of others around the country by announcing its decision to sharply curtail and scrutinize its coverage of uterine resection operations performed by gynecologists across the nation.
Indeed, the gynecological industry finds itself “externally regulated”.
Why is that? Simply put, because the gynecological leadership failed to appropriately “self-regulate” when faced with the reality of a catastrophic public health hazard.
The recent move by UnitedHealth was triggered by our yearlong campaign to enforce a ban on a widely used gynecological practice, known as morcellation. Because for over 2 decades, minimally invasive gynecologists across the world, had been spreading and upstaging unsuspected and deadly cancers by using this practice. Out of the Hundreds and thousands of women undergoing uterine resection for symptomatic fibroids annually worldwide, somewhere around one out of every 150-350 were falling victim to a deadly hazard.
Why? Because the specialty of gynecology was assuming that tumors of the uterus, widely known as fibroids, are benign.
We highlighted and publicized this severe and negligent error in practice using the free press to inform the populace – because almost all our colleagues in medicine stood on academic ceremony and failed to fight alongside us. Certainly most gynecologists fought back and characterized our alarm as an “overblown publicity campaign”. And leading gynecological industry trade groups mounted a vigorous defense, which continues to date.
Why? Because, an entrenched and well-marketed practice was generating a large revenue-stream for many a gynecological practice across the nation. Of course it hurts to be forced into giving up such a comfortable thing – it is tough to give up “steak off one’s plate”. So the professional defense was vigorous, and it continues straight from the top, draped in false claims of “majority benefit”, “women’s choice” and even “patient safety”.
But the simple and powerful truth is that this avoidable practice has led to the unnecessary or premature deaths of many hundreds of unsuspecting women.
It is a pure truth that men and women of common sense, reason and ethics see with clarity - but not the professionals who are fully invested in making a living from this practice. And, very certainly, not the FDA regulators who see these professionals as equal stakeholders to the American patient, to the consumer and to those harmed.
So in November 2014 the Food and Drug Administration, after what was likely a significant internal battle, only managed to put a “black-box” label on this power morcellator device - despite overwhelming evidence of avoidable harm to many women.
The FDA commissioner, Margaret Hamburg, was too soft and failed to protect the public from a very clear hazard. This failure of Dr. Hamburg’s was a result of two factors: 1) her own inability to act with urgency in the face of a clear women’s health hazard and 2) corruption of mission at the FDA's Center for Devices and Radiological Health (CDRH). This federal failure to protect patient safety in the medical device space will be remembered as a historic one on the part of FDA commissioner, Hamburg. And we believe it will soon lead to the ouster of the current CDRH leadership by Congressional oversight – certainly Dr. Margaret Hamburg, herself, is now gone.
But most remarkably for us as believers in free-market economics and responsible federal regulation, the recent move by UnitedHealthcare points to the capacity of our economy to self-correct and heal – where both professional and federal regulation have failed the people. But such effective market self-regulation only results when the people’s voice interacts with the free press with efficacy – as did the campaign to end morcellation. After all, as is widely known to the agents of our free press, “the light of day is the best disinfectant”.
Incredibly, where gynecological surgery trade organizations have failed to effectively self-regulated to protect their patients, where a group of medical device manufacturers have failed to protect their costumers and where federal public health agents failed to protect public health – a third industry is regulating them all.
Why? Because the insurance industry “bean-counters” looked in their databases and came face-to-face with a terrifying reality: That for over 2 decades our limited insurance dollars have been funding a practice that devastates one in 156-350 unsuspecting women. Every upstaged cancer not only represents an irrecoverable human loss, it triggers a large downstream cost of care for the harmed patient. Neither cost is acceptable to insurance actuaries and the industry’s executives – or to any people of reason and ethics.
The beauty of free market capitalism interacting with the free press and democratic forces in America is that when an industry ethically misbehaves or fails, it is regulated actively – either by our federal government or by other industries!
The gynecological surgery industry has brought this level of external regulation, over its most commonly performed procedure, upon itself. Gynecological surgeons and their leaders failed to take measure of our warnings in November 2013 from Boston, when the avoidable upstaging of cancer was made visible beyond a doubt. So their vociferous objections over this external restraint and oversight are akin to those of a 2-year old.
We know that soon, the United States Congress will act with definition - to Protect and to serve, the people from ethical, corporate and FDA failures - as is its framing purpose.
But for now, our kudos and high cheers go to UnitedHealth and its executives for acting in the best interest of public health. -
UnitedHealth to require special OK for most inpatient hysterectomies
Mar 12, 2015 | St. Louis Post-Dispatch
By Danielle Paquette
UnitedHealth, the country’s largest insurer, will soon require doctors to get permission before performing most types of inpatient hysterectomies, a procedure in which the uterus is removed, often to prevent or treat cancer.
The move follows lengthy debate over a surgical device believed by many medical researchers to spread cancer in patients — and highlights how insurers can also play watchdog.
Sharper limits on procedures are an old cost-cutting tool in the insurance business, said Sabrina Corlette, a senior research fellow at the Center on Health Insurance Reform at Georgetown University. But they typically apply to new or elective surgeries. Hysterectomies are often necessary for patients with life-threatening tumors.
So it’s natural to wonder: Does your insurer really know better than your physician?
“These decisions are best made between a physician and a patient, not a third-party administrative decision-maker,” the American College of Obstetricians and Gynecologists told the Wall Street Journal.
“I don’t really want them telling me what type of hysterectomy I should be doing,” added Mike Norgard, a gynecologist, in the same story.
Hysterectomies are the second most common surgical procedure for women, though the number of inpatient hysterectomies has declined sharply over the past 15 years, according to a 2013 study.
UnitedHealth will now require special approval for all nonvaginal hysterectomies. Vaginal hysterectomies, which tend to cost less, account for less than one-third of total hysterectomies performed each year.
But UnitedHealth says it is limiting the procedure to vaginal hysterectomies because they produce better outcomes and fewer complications. The company aims to curb use of laparoscopic power morcellators, or electric blades used to extract tissue through abdominal incisions. Scientists say the devices can miss bits of cancerous tissue that grow into new tumors, boosting the risk of cancer fatality.
The Food and Drug Administration has also weighed in, recently declaring that doctors shouldn’t use the device — commonly used during abdominal procedures — on most women. The FDA started investigating morcellators two years ago, after a Wall Street Journal story shed light on a prominent cancer case in Boston. Dozens more patients have since reported that morcellation might have worsened their cancers. (Young women who wish to preserve their fertility may request the procedure to remove harmful tissue without undergoing a full hysterectomy.)
But beyond the immediate health concerns, some worry about insurance companies limiting the procedures. Aetna and Cigna, two other major insurers, are not following suit.
“Is it appropriate for the insurance company to stand in the shoes of the doctor and say, ‘We know better?’” Corlette said. “Well, evidence has built up over years that suggests — as much as we hate to think this — that doctors are motivated by financial reasons. When doctors are paid per procedure, you see they perform lots of procedures.”
UnitedHealth will start enforcing its stricter hysterectomy rules next month.
Vaginal hysterectomies performed on an outpatient basis won’t require preauthorization by UnitedHealth. The method, which does not use morcellators, is considered by many doctors as a cheaper and less invasive option.
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Morcellation Foe Presses On Despite Return of Cancer
Mar 10, 2015 | MedScape
By Robert Lowes
During a telephone interview, her voice at times sounded weak.
Granted, a tired tone might be expected of a woman who had undergone surgery just 2 weeks earlier to remove metastatic cancer. And who, with her husband, is raising six children — four boys and two girls, ages 13 to 2.
Amy Reed, MD, PhD, nevertheless comes across as nothing but resilient. The anesthesiologist whose occult uterine cancer was upstaged as a result of laparoscopic power morcellation during a hysterectomy remains a staunch patient-safety advocate despite the recent return of her disease. Her high-profile case already has spurred a retreat from the use of the tissue-shredding devices, abetted by strong warnings from the US Food and Drug Administration (FDA) about the risk of dispersing occult cancer in abdominal cavities. However, she and her husband, Hooman Noorchashm, MD, PhD, hope to persuade gynecologic surgeons to abandon the technology entirely.
In addition, Dr Reed plans to conduct bench research on how to curb her particular cancer's growth. Dr Noorchashm, a cardiothoracic surgeon, will join her in the laboratory. Both are experienced researchers with doctorates in immunology and have joint publication credits.
But first comes the matter of recovery.
"Right now, I'm focusing on my health," the 41-year-old Dr Reed told Medscape Medical News.
Leg Numbness, Then Discovery of a New Tumor
A power morcellator shreds the uterus and fibroids into pieces that can be easily removed through the vagina or a laparoscopic incision, averting the need for a larger incision to remove the tissue intact.
Dr Reed underwent a laparoscopic hysterectomy with morcellation in October 2013 to remove uterine fibroids thought to be benign. After discovering that the procedure had resulted in the upstaging of a previously undiagnosed uterine leiomyosarcoma to stage 4, Dr Reed underwent cytoreduction and hyperthermic intraperitoneal chemotherapy, followed by six rounds of systemic chemotherapy. Subsequent MRI and CT scans indicated that she was cancer free.
Then, back on the job at the Hospital of the University of Pennsylvania in February, she noticed numbness in her upper left leg. Dr Reed initially chalked it up to long work hours on her feet, but a routine MRI pelvic screening revealed a tumor behind her left kidney that impinged on her spine and the second lumbar nerve. On February 20, a neurosurgeon excised the tumor and performed a laminectomy and lumbar fusion.
The tumor turned out to be cancerous, similar to the one in her uterus.
Now Dr Reed faces several rounds of radiation treatment ASAP. "This is a really aggressive cancer," she said. "We would be deluding ourselves if we think we can sit back and wait."
The medical couple recognizes that the cancer, now having metastasized, may be a lifetime foe.
"We're in for a big fight," said Dr Noorchashm in a separate interview with Medscape Medical News. "We're assuming that this disease is present in microscopic form elsewhere, and we're going after it. It's hard to predict where it will return."
"I'm hoping it takes more of a chronic-type route (in which) it comes up occasionally and we...deal with it," said Dr Reed.
The couple has assembled a team of medical colleagues to help chart a path forward after the end of radiation treatment. One option under consideration is treating Dr Reed with mammalian target of rapamycin (mTOR) inhibitors, which curb runaway cell growth and proliferation. Another possibility is T-cell therapy to goad these bloodstream guard dogs into attacking the cancer cells. Both treatments are largely experimental.
"We're going with extreme, outside-of-the-box thinking," said Dr Noorchashm, an assistant professor of surgery at the Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia. "Amy and I intend to cure this thing. It's not outside the range of our capacity. It's a clump of dividing cells. We should be able to get this."
The couple also intends to play a direct role in this battle by eventually working in the laboratory together to find a therapy or regimen "to keep the cancer at bay," said Dr Reed. "We will pour all our resources into looking at these tumors and things that inhibit their growth. mTOR inhibition is definitely one of the things we're going to look at."
A String of Victories
Dr Reed and Dr Noorchashm can point to a string of victories since they went public with their criticism of power morcellators as too dangerous for gynecologic surgery. In April 2014, the FDA recommended that surgeons stop using the devices for hysterectomy or myomectomy in most women with uterine fibroids because of the risk of dispersing occult cancer. One in 350 women who undergo morcellation to remove fibroids have an unsuspected uterine sarcoma such as leiomyosarcoma, the FDA reported. The agency added an even tougher boxed warning 7 months later.
The healthcare industry last year quickly responded to the FDA alarm bells. Johnson & Johnson voluntarily withdrew its morcellators from the market because of cancer "uncertainty." Giant hospital chain HCA Holdings banned the use of power morcellators for removing uterine fibroids at its facilities. Highmark, a health insurer in the eastern United States, stopped paying for laparoscopic power morcellation in gynecologic procedures.
Still another insurer joined the backlash in February. UnitedHealthcare said that it would requirepreauthorization for all hysterectomies other than vaginal procedures performed on an outpatient basis. The company said that the FDA's warnings about the risk for morcellation dispersing occult cancer contributed to its decision.
These trends bode well for fewer procedures performed with power morcellation, said Dr Reed. However, she and her husband would like to bring that number down to zero. Otherwise, the number of women who have died from upstaged occult cancer such as Dr Reed's will only increase, they argue.
"We want the gynecologic community to collectively say, ‘This is something we should not be doing,' " she said.
The couple has not been able to convince the FDA to ban power morcellators outright, but they hope at least to reform the FDA's process for approving medical devices. Power morcellators were cleared through the agency's 510(k) process, which requires that a manufacturer need only prove that its product is substantially the same as a device already approved by the agency. Dr Reed and Dr Noorchashm contend that patients are ill served by a process that does not require premarket safety testing and lacks a mechanism for monitoring adverse outcomes. They are trying to persuade members of Congress to hold hearings on the deficiencies of the 510(k) approval pathway.
Dr Noorchashm, who has been a far more vocal advocate of eliminating gynecologic morcellation than his ailing wife, is eager to testify. "All I need is 5 minutes," he said.
"Look at What's in Front of You Today"
In taking their stand against laparoscopic morcellators, the couple has clashed with several medical societies that believe the devices still have a place in the surgeon's toolbox. The AAGL, formerly known as the American Association of Gynecologic Laparoscopists, holds that "appropriately performed" power morcellation outweighs the risk for open surgery in low-risk patients, provided there is informed consent and careful patient selection. Capturing and removing shredded tissue in an endobag appears to minimize the risk for dispersal, the AAGL states. The Society of Gynecologic Oncology takes a similar position, as does the American College of Obstetricians and Gynecologists, which expects preoperative screening for uterine cancer to improve.
The controversy has gotten personal at times. SeveralMedscape Medical News readers have commented that although they wish the best for Dr Reed, they think that Dr Noorchashm's understandably emotional response to her plight gets the best of his reasoning on clinical issues. He begs to differ.
"We have four doctorates between us and a record that says we're not just crazy people," said Dr Noorchashm. "The results of what we've done (such as the FDA warnings and product withdrawals} speak for themselves."
People who are harmed by something, he added, "have the most clarity on what's wrong."
Family conversations about her cancer have produced another kind of clarity, said Dr Reed. She and her husband have learned to be very honest with their children as well as with themselves. And to keep it simple.
"In the beginning, it was hard," she said. "We didn't know what to say. When you're talking to a kid, it forces you to state things very bare-bones. It's even somewhat comforting because you strip away a lot of the fear and the what-if's.
"They ask you questions like, 'Are you going to die?' I say, 'Well, everybody dies. I feel okay today.'
"They say, 'Is the cancer going to come back?' I say, 'I hope not. If it does, we'll deal with it.' "
"You don't go down all those horrible, what-if pathways with the kids. And I don't think we should do that as adults.
"Look at what's in front of you today."
Such as the 2-year-old boy who woke up from a nap and interrupted the phone interview. What Dr Reed's son said was hard to make out, except for the word "Mommy."
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Women’s Health Devices Taken to Task by Citizen Petitions
Mar 9, 2015 | Medical Device And Diagnostic Industry
By Marie Thibault
Recent citizen petition letters find fault with two female health devices—the laparoscopic power morcellator and a permanent birth control insert. Both devices have been the subject of recent heated debate and the petitioners lobby for FDA to yank them from the market.
In a February 20 petition, lawyers from the Law Office of Koch Parafinczuk & Wolf, P.A. in Fort Lauderdale, FL take issue with Essure permanent birth control, saying they represented hundreds of women who received the Essure inserts. The petitioners claim that medical data was fraudulently fixed during the premarket approval process, and that conditions of the approval order and federal laws have been violated several times. Included in the letter is a request for FDA to suspend the device’s approval.
The Essure system, now owned by Bayer after its 2013 acquisition of Conceptus, involves hysteroscopic placement of nickel-titanium alloy inserts into the fallopian tubes, which, with tissue ingrowth, block the fallopian tubes and result in permanent birth control.
The petitioners maintain that the device has led to adverse events including device migration and organ perforation. The petitioners claim that“medical records of trial participants were altered to reflect (1) favorable data, including less pain then [sic] was experienced and (2) certain birth dates,” and that the company did not follow several requirements of the Essure approval order and of federal laws, including timely approval reports and notices of adverse events.
Essure has been the subject of controversy before. In 2013, famous consumer advocate Erin Brockovich took uphttp://www.essureprocedure.net/ ">a campaign against Essure procedure, documenting the side effects women were reporting.
In response to a request for comment, a Bayer spokesperson said in an e-mailed statement, "The Citizen’s Petition regarding Essure was submitted to the FDA by a law firm that has filed five Essure product liability lawsuits naming Bayer as a defendant. The allegations made in the Citizens Petition are similar to those stated in the lawsuits. Bayer stands behind the safety and efficacy of Essure and will aggressively defend itself in Court. Bayer will also continue to work with the FDA on this issue and will respond to any questions the agency may have related to this Citizen’s Petition."
The company's statement went on to address two specific claims in the petition. First, the petition states that FDA was not notified of an internal Excel file with over 16,000 complaints since 2011. Bayer said, "We can confirm that in 2013 prior to the acquisition, Conceptus provided the FDA with a CD-ROM that included 16,047 complaints in an Excel file. FDA acknowledged receipt of the CD-ROM in an Establishment Inspection Report sent to Bayer on June 26, 2013. There was no failure to notify FDA of these complaints as alleged by the petitioner."
On the alleged alteration of clinical data, Bayer said, "Although we cannot discuss individual clinical trial participants, we have seen the materials submitted with the Citizen’s Petition and strongly disagree with those allegations. Based on good clinical practice (GCP), it is not uncommon for investigators to make edits prior to finalization on investigational reports."
Another recent citizen petition, filed on March 4, came directly from a patient, Sarah Salem-Robinson. She calls for FDA to ban laparoscopic power morcellators, which are under fire for potentially spreading and seeding rare uterine cancers. In her letter, Salem-Robinson argues that though FDA has published an advisory against use of the devices, many gynecologists continue to use power morcellators and to minimize the risk of spreading unknown cancer.
“As a victim of the power morcellator myself, (one in a list of over 400 known women, some alive and many deceased) and also an OB/GYN Physician Assistant for eleven years, I am appalled and find it ‘criminal’ that this faulty oncologic designed device which promotes seeding of cancer, has grown in popularity within the GYN community over the past two decades,” Salem-Robinson wrote.
The laparoscopic power morcellator has been hotly debated over the past year. A physician couple, Dr. Hooman Noorchashm and Dr. Amy Reed, have been loud advocates for banning the devices. Dr. Reed had a hysterectomy with the device and found out soon after that she had uterine sarcoma. Last year, FDA published safety communications about the devices and maker Johnson & Johnson issued a voluntary recall of its power morcellators in July 2014. Health insurers Highmark and United Healthcare have said they will not cover use of the laparoscopic power morcellators during hysterectomies, and a few health systems and hospital chains have stopped using the devices.
Makers of laparoscopic power morcellators did not immediately return requests for comment.
FDA has acknowledged receipt of both citizen petitions, but has not taken any other action.
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UnitedHealth decision sparks debate over payers as 'watchdogs'
Mar 11, 2015 | Health Care Dive
By Heather Caspi
UnitedHealth's recent decision to require special approval for certain types of inpatient hysterectomies, citing medical evidence, has raised eyebrows in the medical community over the insurer expanding its role in medical decision-making.
The company says it is promoting vaginal hysterectomies over the use of laparoscopic power morcellators on the basis that they result in better outcomes and not because they are also less expensive.
Sam Ho, chief medical officer for UnitedHealth's insurance business, told the Wall Street Journal, "We needed to do more on behalf of our members to ensure that they would get the safest and most effective method" of hysterectomy.
The Food and Drug Administration is in the same camp, having recentlywritten that physicians should not use morcellators on most women.
While insurers have long been limiting procedures to control medical costs, those limits typically apply to new or elective surgeries, Sabrina Corlette, senior research fellow at the Center on Health Insurance Reform at Georgetown University, told the Washington Post.
"We believe this is best left up to the physician and patient based on clinical circumstances."
Among other major insurers, Anthem is the only other company that requires pre-authorization for hysterectomies. An Anthem spokeswoman told the WSJ that the company began to limit hysterectomies just last year due to concerns that physicians were jumping to them as a solution to treat fibroids, without fully considering other options.
Cigna and Aetna do not require any insurer authorization for hysterectomies. "We believe this is best left up to the physician and patient based on clinical circumstances," an Aetna spokeswoman told the WSJ.Impact on insurance industry
Is it appropriate for the insurance company to stand in the shoes of the doctor and say, We know better?
The question now is whether any insurers will continue to push limits in driving medical choices alongside physicians and patients—essentially developing a role as medical watchdogs—and whether there will be push-back or appreciation if they do.
As for whether it's appropriate for an insurer to take a watchdog role, experts are voicing concerns, but also some potential benefits.
Corlette said that she can't say whether UnitedHealth's decision is setting a precedent.
"Is it appropriate for the insurance company to stand in the shoes of the doctor and say, 'We know better?'" Corlette told the Post. "Well, evidence has built up over years that suggests—as much as we hate to think this—that doctors are motivated by financial reasons. When doctors are paid per procedure, you see they perform lots of procedures."
Mark Miller, director of business development at Marina Del Rey Hospital in California, does not see the decision as a precedent given that prior authorization guidelines are very common and that this new policy is based on ACOG recommendations.
"Payers, like UnitedHealth, are protectors of the member's premium dollar and take the role of appropriate procedures and payments very seriously," Miller tells Healthcare Dive. "I believe providers appreciate clear prior authorization guidelines versus no guidelines at all. Also, a guideline or policy can also be viewed as the catalyst for a healthy discussion about this procedure."
Miller suggests that while this may appear as a "watchdog" approach, the physician still has the opportunity to help set policy through advocacy if any confusion exists regarding procedures and outcomes.
"It's a huge deal."
Experts suggest that UnitedHealth's policy is indeed likely to drive physicians toward selecting vaginal hysterectomies, though it will also depend on how the policy is implemented.
Catherine Matthews, a board member for the American Urogynecologic Society, suggests there could be both pros and cons to the decision.
She told the WSJ that while she has reservations about an insurer guiding physicians' choices, this move could drive training improvements, because gynecologists often receive insufficient instruction on vaginal procedures.
"It's a huge deal," Matthews said. "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."
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