CNN Exclusive: California launches investigation following stunning admission by Aetna medical director

(CNN)California’s insurance commissioner has launched an investigation into Aetna after learning a former medical director for the insurer admitted under oath he never looked at patients’ records when deciding whether to approve or deny care.

“If the health insurer is making decisions to deny coverage without a physician actually ever reviewing medical records, that’s of significant concern to me as insurance commissioner in California — and potentially a violation of law,” he said.
Aetna, the nation’s third-largest insurance provider with 23.1 million customers, told CNN it looked forward to “explaining our clinical review process” to the commissioner.
    The California probe centers on a deposition by Dr. Jay Ken Iinuma, who served as medical director for Aetna for Southern California from March 2012 to February 2015, according to the insurer.
    During the deposition, the doctor said he was following Aetna’s training, in which nurses reviewed records and made recommendations to him.
    Jones said his expectation would be “that physicians would be reviewing treatment authorization requests,” and that it’s troubling that “during the entire course of time he was employed at Aetna, he never once looked at patients’ medical records himself.”
    “It’s hard to imagine that in that entire course in time, there weren’t any cases in which a decision about the denial of coverage ought to have been made by someone trained as a physician, as opposed to some other licensed professional,” Jones told CNN.
    “That’s why we’ve contacted Aetna and asked that they provide us information about how they are making these claims decisions and why we’ve opened this investigation.”
    The insurance commissioner said Californians who believe they may have been adversely affected by Aetna’s decisions should contact his office.
    Members of the medical community expressed similar shock, saying Iinuma’s deposition leads to questions about Aetna’s practices across the country.
    “Oh my God. Are you serious? That is incredible,” said Dr. Anne-Marie Irani when told of the medical director’s testimony. Irani is a professor of pediatrics and internal medicine at the Children’s Hospital of Richmond at VCU and a former member of the American Board of Allergy and Immunology’s board of directors.
    “This is potentially a huge, huge story and quite frankly may reshape how insurance functions,” said Dr. Andrew Murphy, who, like Irani, is a renowned fellow of the American Academy of Allergy, Asthma and Immunology. He recently served on the academy’s board of directors.

    The Gillen Washington case

    The deposition by Aetna’s former medical director came as part of a lawsuit filed against Aetna by a college student who suffers from a rare immune disorder. The case is expected to go to trial later this week in California Superior Court.
    Gillen Washington, 23, is suing Aetna for breach of contract and bad faith, saying he was denied coverage for an infusion of intravenous immunoglobulin (IVIG) when he was 19. His suit alleges Aetna’s “reckless withholding of benefits almost killed him.”
    Aetna has rejected the allegations, saying Washington failed to comply with their requests for blood work. Washington, who was diagnosed with common variable immunodeficiency, or CVID, in high school, became a new Aetna patient in January 2014 after being insured by Kaiser.
    Aetna initially paid for his treatments after each infusion, which can cost up to $20,000. But when Washington’s clinic asked Aetna to pre-authorize a November 2014 infusion, Aetna says it was obligated to review his medical record. That’s when it saw his last blood work had been done three years earlier for Kaiser.
    Despite being told by his own doctor’s office that he needed to come in for new blood work, Washington failed to do so for several months until he got so sick he ended up in the hospital with a collapsed lung.
    Once his blood was tested, Aetna resumed covering his infusions and pre-certified him for a year. Despite that, according to Aetna, Washington continued to miss infusions.
    Washington’s suit counters that Aetna ignored his treating physician, who appealed on his behalf months before his hospitalization that the treatment was medically necessary “to prevent acute and long-term problems.”
    “Aetna is blaming me for what happened,” Washington told CNN. “I’ll just be honest, it’s infuriating to me. I want Aetna to be made to change.”
    During his videotaped deposition in October 2016, Iinuma — who signed the pre-authorization denial — said he never read Washington’s medical records and knew next to nothing about his disorder.
    Questioned about Washington’s condition, Iinuma said he wasn’t sure what the drug of choice would be for people who suffer from his condition.
    Iinuma further says he’s not sure what the symptoms are for the disorder or what might happen if treatment is suddenly stopped for a patient.
    “Do I know what happens?” the doctor said. “Again, I’m not sure. … I don’t treat it.”
    Iinuma said he never looked at a patient’s medical records while at Aetna. He says that was Aetna protocol and that he based his decision off “pertinent information” provided to him by a nurse.
    “Did you ever look at medical records?” Scott Glovsky, Washington’s attorney, asked Iinuma in the deposition.
    “No, I did not,” the doctor says, shaking his head.
    “So as part of your custom and practice in making decisions, you would rely on what the nurse had prepared for you?” Glovsky asks.
    “Correct.”
    Iinuma said nearly all of his work was conducted online. Once in a while, he said, he might place a phone call to the nurse for more details.
    How many times might he call a nurse over the course of a month?
    “Zero to one,” he said.
    Glovsky told CNN he had “never heard such explosive testimony in two decades of deposing insurance company review doctors.”

    Aetna’s response

    Aetna defended Iinuma, who is no longer with the company, saying in its legal brief that he relied on his “years of experience” as a trained physician in making his decision about Washington’s treatment and that he was following Aetna’s Clinical Policy Bulletin appropriately.
    “Dr. Iinuma’s decision was correct,” Aetna said in court papers. “Plaintiff has asserted throughout this litigation that Dr. Iinuma had no medical basis for his decision that 2011 lab tests were outdated and that Dr. Iinuma’s decision was incorrect. Plaintiff is wrong on both counts.”
    In its trial brief, Aetna said: “Given that Aetna does not directly provide medical care to its members, Aetna needs to obtain medical records from members and their doctors to evaluate whether services are ‘medically necessary.’ Aetna employs nurses to gather the medical records and coordinate with the offices of treating physicians, and Aetna employs doctors to make the actual coverage-related determinations.
    “In addition to applying their clinical judgment, the Aetna doctors and nurses use Aetna’s Clinical Policy Bulletins (‘CPBs’) to determine what medical records to request, and whether those records satisfy medical necessity criteria to support coverage. These CPBs reflect the current standard of care in the medical community. They are frequently updated, and are publicly available for any treating physician to review.”
    Jones, the California insurance commissioner, said he couldn’t comment specifically on Washington’s case, but what drew his interest was the medical director’s admission of not looking at patients’ medical records.
    “What I’m responding to is the portion of his deposition transcript in which he said as the medical director, he wasn’t actually reviewing medical records,” Jones told CNN.
    He said his investigation will review every individual denial of coverage or pre-authorization during the medical director’s tenure to determine “whether it was appropriate or not for that decision to be made by someone other than a physician.”
    If the probe determines that violations occurred, he said, California insurance code sets monetary penalties for each individual violation.
    CNN has made numerous phone calls to Iinuma’s office for comment but has not heard back. Heather Richardson, an attorney representing Aetna, declined to answer any questions.
    Asked about the California investigation, Aetna gave this written statement to CNN:
    “We have yet to hear from Commissioner Jones but look forward to explaining our clinical review process.
    “Aetna medical directors are trained to review all available medical information — including medical records — to make an informed decision. As part of our review process, medical directors are provided all submitted medical records, and also receive a case synopsis and review performed by a nurse.
    “Medical directors — and all of our clinicians — take their duties and responsibilities as medical professionals incredibly seriously. Similar to most other clinical environments, our medical directors work collaboratively with our nurses who are involved in these cases and factor in their input as part of the decision-making process.”

    ‘A huge admission’

    Dr. Arthur Caplan, founding director of the division of medical ethics at New York University Langone Medical Center, described Iinuma’s testimony as “a huge admission of fundamental immorality.”
    “People desperate for care expect at least a fair review by the payer. This reeks of indifference to patients,” Caplan said, adding the testimony shows there “needs to be more transparency and accountability” from private, for-profit insurers in making these decisions.
    Murphy, the former American Academy of Allergy Asthma and Immunology board member, said he was “shocked” and “flabbergasted” by the medical director’s admission.
    “This is something that all of us have long suspected, but to actually have an Aetna medical director admit he hasn’t even looked at medical records, that’s not good,” said Murphy, who runs an allergy and immunology practice west of Philadelphia.
    “If he has not looked at medical records or engaged the prescribing physician in a conversation — and decisions were made without that input — then yeah, you’d have to question every single case he reviewed.”
    Murphy said when he and other doctors seek a much-needed treatment for a patient, they expect the medical director of an insurance company to have considered every possible factor when deciding on the best option for care.

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    “We run into the prior authorization issues when we are renewing therapy, when the patient’s insurance changes or when an insurance company changes requirements,” he said.
    “Dealing with these denials is very time consuming. A great deal of nursing time is spent filling and refilling out paperwork trying to get the patient treatment.
    “If that does not work, then physicians need to get involved and demand medical director involvement, which may or may not occur in a timely fashion — or sometimes not at all,” he said. “It’s very frustrating.”

    Read more: http://www.cnn.com/2018/02/11/health/aetna-california-investigation/index.html

    Swiss pharma company Roche is buying Flatiron Health for $1.9 billion

    Roche, the global pharmaceutical company from Switzerland, today announced it will scoop up Flatiron Health, a startup analyzing real-time oncology data to help cancer patients and doctors, in a $1.9 billion deal.

    Flatiron has also confirmed the deal to TechCrunch.

    Two years ago, Roche led a $175 million deal in the startup at a $1.2 billion valuation. At the time of the deal, Roche agreed to buy several of Flatiron’s subscription-based software products, positioning the company for an eventual initial public offering.

    Flatiron CEO and co-founder Nat Turner said back then he planned to IPO in “two to three years,” according to The New York Times. The plan was to raise yet another round of funding before doing so. However, it seems Roche has other plans.

    “This is an important step in our personalised healthcare strategy for Roche, as we believe that regulatory-grade real-world evidence is a key ingredient to accelerate the development of, and access to, new cancer treatments,” Roche CEO Daniel O’Day said in a press release regarding the acquisition today. “As a leading technology company in oncology, Flatiron Health is best positioned to provide the technology and data analytics infrastructure needed not only for Roche, but for oncology research and development efforts across the entire industry.”

    O’Day mentioned in a company release the need to preserve Flatiron’s autonomy as a subsidiary. Turner also mentioned to CNBC that all employees, including the founding team, would stay on with the company.

    Founding members Turner and Zach Weinberg both hailed from Google before pitching into healthcare, and it’s important to note this is the first big return for GV’s healthcare bets. In total, Flatiron was able to raise more than $313 million before Roche offered to buy the startup.

    The $1.9 billion deal, which will be on a fully diluted basis and subject to certain conditions, is expected to close in the first half of this year, according to Flatiron.

    Read more: https://techcrunch.com/2018/02/15/swiss-pharma-company-roche-is-buying-flatiron-health-for-1-9-billion/

    German cities to trial free public transport to cut pollution

    Plan to be tested in five cities in effort to meet EU air pollution targets and avoid big fines

    German cities to trial free public transport to cut pollution

    Plan to be tested in five cities in effort to meet EU air pollution targets and avoid big fines

    Read more: https://www.theguardian.com/world/2018/feb/14/german-cities-to-trial-free-public-transport-to-cut-pollution

    Koch-backed group fights paid sick leave laws as flu sweeps US

    The lobbying group that led the assault on Obamacare has targeted movements across the US to ensure workers can get needed time off

    Koch-backed group fights paid sick leave laws as flu sweeps US

    The lobbying group that led the assault on Obamacare has targeted movements across the US to ensure workers can get needed time off

    Read more: https://www.theguardian.com/us-news/2018/feb/11/paid-sick-leave-koch-brothers-nfib

    This Swedish fitness trend combines running with picking up litter

    Image: Getty Images

    Forget about Hygge, Lagom, and Ikea’s attempt to start a twin duvet revolution. There’s a new Scandinavian trend in town. 

    This trend encourages people to pick up litter while out running. So, it’s not just good for your health, it’s also good for the environment. 

    It’s called ‘plogging’—a portmanteau of jogging and the Swedish plocka upp, meaning ‘pick up.’ 

    So hot is this new trend that fitness app Lifesum is allowing its users to log and track their plogging activity as a workout. 

    Plogging combines going for a run with intermittent squatting or lunging (to collect rubbish), which actually sounds like a pretty satisfying workout. According to Lifesum, a typical user will burn 288 calories in 30 minutes of plogging, which is more or less the same as what’s burned off while jogging.  

    As with all fitness trends, there are plenty of #plogging pics on Instagram, offering a glimpse of what this trend looks like IRL. Ploggers take plastic bags along with them so they can store the collected litter they find along their route.

    Swedish fitness app Lifesum claims it’s the first health app to allows its 25 million users to log their plogging activity. Those using the health app can log plogging as a fitness activity, in the same way that they would log running or walking, and the app will estimate how many calories have been burned. 

    Image: lifesum / rachel thompson

    Lifesum has also teamed up with the non-profit Keep America Beautiful to provide an online resource for ploggers who want to log the rubbish they’ve collected. 

    Mike Rosen, senior vice president at Keep America Beautiful, thinks plogging is a great way to encourage people to make a difference in their local environment. 

    “Plogging is brilliant because it is simple and fun, while empowering everyone to help create cleaner, greener and more beautiful communities,” Rosen said in a statement. “All you need is running gear and a bag for trash or recyclables, and you are not only improving your own health, but your local community too.”

    Plog away!

    Read more: https://mashable.com/2018/02/13/plogging-fitness-trend/

    Sony apologises for making light of food allergies in ‘Peter Rabbit’

    Sony Pictures and the Peter Rabbit filmmakershave apologised for making light of allergies following calls to boycott the movie, which hit U.S. cinemas over the weekend. 

    A scene in the new adaptation of Beatrix Potter’s classic shows character Tom McGregor, who’s allergic to blackberries, being pelted with the berries by Peter and his friends. One of the berries lands in Tom’s mouth, and he has to use an EpiPen to treat his allergic reaction. 

    The scene prompted a massive outcry on social media, and many parents called on people to boycott the film, which they deemed to find “humor in bullying” people living with allergies. 

    Brittany Dye, a parent of a child with a severe food allergy, penned an open letter calling on Sony Pictures to pull the film, which she said “mocks children with disabilities.” 

    “If someone launched green peas, or lentils, or any of the other 6 foods my son is allergic to into his mouth the way the rabbits did to McGregor in the movie with blackberries, he would need timely epinephrine. If he did not receive it, he would likely die,” wrote Dye in the letter. 

    One parent of a daughter with allergies called the scene “sickening.” 

    “Please stop showing anaphylaxis as something that is funny,” wrote another person on Twitter. 

    Another parent of a child with “severe food allergies” called the film “absolutely disgusting.” 

    In a Facebook post, the Kids With Food Allergies (KFA) Foundation wrote that the scene “may be disturbing to young viewers” with food allergies. 

    “KFA believes that food allergy ‘jokes’ are harmful to our community,” read the post. “During a reaction, patients require the life-saving drug epinephrine and must go to the nearest hospital for follow-up treatment.” 

    They added that the scene was harmful to those living with allergies. “Making light of this condition hurts our members because it encourages the public not to take the risk of allergic reactions seriously, and this cavalier attitude may make them act in ways that could put an allergic person in danger,” the post continued. 

    A spokesperson for Sony Pictures said in a statement that the film “should not have made light” of the character’s allergy “even in a cartoonish, slapstick way.” 

    “We sincerely regret not being more aware and sensitive to this issue, and we truly apologize,” the statement continued.

    Read more: https://mashable.com/2018/02/12/peter-rabbit-movie-allergies/

    Huge levels of antibiotic use in US farming revealed

    Concerns raised over weakened regulations on imports in potential post-Brexit trade deals

    Huge levels of antibiotic use in US farming revealed

    Concerns raised over weakened regulations on imports in potential post-Brexit trade deals

    Read more: https://www.theguardian.com/environment/2018/feb/08/huge-levels-of-antibiotic-use-in-us-farming-revealed

    Spread of breast cancer linked to compound in asparagus and other foods

    Using drugs or diet to reduce levels of asparagine may benefit patients, say researchers

    Spread of breast cancer linked to compound in asparagus and other foods

    Using drugs or diet to reduce levels of asparagine may benefit patients, say researchers

    Read more: https://www.theguardian.com/science/2018/feb/07/cutting-asparagus-could-prevent-spread-of-breast-cancer-study-shows

    The Second Coming of Ultrasound

    Before Pierre Curie met the chemist Marie Sklodowska; before they married and she took his name; before he abandoned his physics work and moved into her laboratory on Rue Lhomond where they would discover the radioactive elements polonium and radium, Curie discovered something called piezoelectricity. Some materials, he found—like quartz and certain kinds of salts and ceramics—build up an electric charge when you squeeze them. Sure, it’s no nuclear power. But thanks to piezoelectricity, US troops could locate enemy submarines during World War I. Thousands of expectant parents could see their baby’s face for the first time. And one day soon, it may be how doctors cure disease.

    Ultrasound, as you may have figured out by now, runs on piezoelectricity. Applying voltage to a piezoelectric crystal makes it vibrate, sending out a sound wave. When the echo that bounces back is converted into electrical signals, you get an image of, say, a fetus, or a submarine. But in the last few years, the lo-fi tech has reinvented itself in some weird new ways.

    Researchers are fitting people’s heads with ultrasound-emitting helmets to treat tremors and Alzheimer’s. They’re using it to remotely activate cancer-fighting immune cells. Startups are designing swallowable capsules and ultrasonically vibrating enemas to shoot drugs into the bloodstream. One company is even using the shockwaves to heal wounds—stuff Curie never could have even imagined.

    So how did this 100-year-old technology learn some new tricks? With the help of modern-day medical imaging, and lots and lots of bubbles.

    Bubbles are what brought Tao Sun from Nanjing, China to California as an exchange student in 2011, and eventually to the Focused Ultrasound Lab at Brigham and Women’s Hospital and Harvard Medical School. The 27-year-old electrical engineering grad student studies a particular kind of bubble—the gas-filled microbubbles that technicians use to bump up contrast in grainy ultrasound images. Passing ultrasonic waves compress the bubbles’ gas cores, resulting in a stronger echo that pops out against tissue. “We’re starting to realize they can be much more versatile,” says Sun. “We can chemically design their shells to alter their physical properties, load them with tissue-seeking markers, even attach drugs to them.”

    Nearly two decades ago, scientists discovered that those microbubbles could do something else: They could shake loose the blood-brain barrier. This impassable membrane is why neurological conditions like epilepsy, Alzheimer’s, and Parkinson’s are so hard to treat: 98 percent of drugs simply can’t get to the brain. But if you station a battalion of microbubbles at the barrier and hit them with a focused beam of ultrasound, the tiny orbs begin to oscillate. They grow and grow until they reach the critical size of 8 microns, and then, like some Grey Wizard magic, the blood-brain barrier opens—and for a few hours, any drugs that happen to be in the bloodstream can also slip in. Things like chemo drugs, or anti-seizure medications.

    This is both super cool and not a little bit scary. Too much pressure and those bubbles can implode violently, irreversibly damaging the barrier.

    That’s where Sun comes in. Last year he developed a device that could listen in on the bubbles and tell how stable they were. If he eavesdropped while playing with the ultrasound input, he could find a sweet spot where the barrier opens and the bubbles don’t burst. In November, Sun’s team successfully tested the approach in rats and mice, publishing their results in Proceedings in the National Academy of Sciences.

    “In the longer term we want to make this into something that doesn’t require a super complicated device, something idiot-proof that can be used in any doctor’s office,” says Nathan McDannold, co-author on Sun’s paper and director of the Focused Ultrasound Lab. He discovered ultrasonic blood-brain barrier disruption, along with biomedical physicist Kullervo Hynynen, who is leading the world’s first clinical trial evaluating its usefulness for Alzheimer’s patients at the Sunnybrook Research Institute in Toronto. Current technology requires patients to don special ultrasound helmets and hop in an MRI machine, to ensure the sonic beams go to the right place. For the treatment to gain any widespread traction, it’ll have to become as portable as the ultrasound carts wheeled around hospitals today.

    More recently, scientists have realized that the blood-brain barrier isn’t the only tissue that could benefit from ultrasound and microbubbles. The colon, for instance, is pretty terrible at absorbing the most common drugs for treating Crohn’s disease, ulcerative colitis, and other inflammatory bowel diseases. So they’re often delivered via enemas—which, inconveniently, need to be left in for hours.

    But if you send ultrasound waves waves through the colon, you could shorten that process to minutes. In 2015, pioneering MIT engineer Robert Langer and then-PhD student Carl Schoellhammer showed that mice treated with mesalamine and one second of ultrasound every day for two weeks were cured of their colitis symptoms. The method also worked to deliver insulin, a far larger molecule, into pigs.

    Since then, the duo has continued to develop the technology within a start-up called Suono Bio, which is supported by MIT’s tech accelerator, The Engine. The company intends to submit its tech for FDA approval in humans sometime later this year.

    Ultrasound sends pressure waves through liquid in the body, creating bubble-filled jets that can propel microscopic drug droplets like these into surrounding tissues.
    Suono Bio

    Instead of injecting manufactured microbubbles, Suono Bio uses ultrasound to make them in the wilds of the gut. They act like jets, propelling whatever is in the liquid into nearby tissues. In addition to its backdoor approach, Suono is also working on an ultrasound-emitting capsule that could work in the stomach for things like insulin, which is too fragile to be orally administered (hence all the needle sticks). But Schoellhammer says they have yet to find a limit on the kinds of molecules they can force into the bloodstream using ultrasound.

    “We’ve done small molecules, we’ve done biologics, we’ve tried DNA, naked RNA, we’ve even tried Crispr,” he says. “As superficial as it may sound, it all just works.”

    Earlier this year, Schoellhammer and his colleagues used ultrasound to deliver a scrap of RNA that was designed to silence production of a protein called tumor necrosis factor in mice with colitis. (And yes, this involved designing 20mm-long ultrasound wands to fit in their rectums). Seven days later, levels of the inflammatory protein had decreased sevenfold and symptoms had dissipated.

    Now, without human data, it’s a little premature to say that ultrasound is a cure-all for the delivery problems facing gene therapies using Crispr and RNA silencing. But these early animal studies do offer some insights into how the tech might be used to treat genetic conditions in specific tissues.

    Even more intriguing though, is the possibility of using ultrasound to remotely control genetically-engineered cells. That’s what new research led by Peter Yingxiao Wang, a bioengineer at UC San Diego, promises to do. The latest craze in oncology is designing the T-cells of your immune system to better target and kill cancer cells. But so far no one has found a way to go after solid tumors without having the T-cells also attack healthy tissue. Being able to turn on T-cells near a tumor but nowhere else would solve that.

    Wang’s team took a big step in that direction last week, publishing a paper that showed how you could convert an ultrasonic signal into a genetic one. The secret? More microbubbles.

    This time, they coupled the bubbles to proteins on the surface of a specially designed T-cell. Every time an ultrasonic wave passed by, the bubble would expand and shrink, opening and closing the protein, letting calcium ions flow into the cell. The calcium would eventually trigger the T-cell to make a set of genetically encoded receptors, directing it it to attack the tumor.

    “Now we’re working on figuring out the detection piece,” says Wang. “Adding another receptor so that we’ll known when they’ve accumulated at the tumor site, then we’ll use ultrasound to turn them on.”

    In his death, Pierre Curie was quickly eclipsed by Marie; she went on to win another Nobel, this time in chemistry. The discovery for which she had become so famous—radiation—would eventually take her life, though it would save the lives of so many cancer patients in the decades to follow. As ultrasound’s second act unfolds, perhaps her husband’s first great discovery will do the same.

    Read more: https://www.wired.com/story/the-second-coming-of-ultrasound/

    For the first time in its history, the Gerber spokesbaby is a child with Down syndrome

    (CNN)This cutie with a contagious smile is 18-month-old Lucas Warren and on Wednesday he made history: He’s the first child with Down syndrome to become Gerber’s “Spokesbaby of the year” in its 91-year history.

    Lucas is from Dalton, Georgia. Gerber picked him from more than 140,000 entries to its photo search contest. The initiative to find the “Gerber Baby” began soon after the company was founded in 1927, when it put out a call looking for a baby to feature in its ads.
    The title means Lucas’ parents will get a $50,000 prize and Lucas will appear on Gerber’s social media channels and will be featured in Gerber ads through the year.
      “We hope this opportunity sheds light on the special needs community and educates people that with acceptance and support, individuals with special needs have the potential to change the world — just like our Lucas,” his mom said.

      Read more: http://www.cnn.com/2018/02/07/health/first-gerber-baby-down-syndrome-trnd/index.html