Olympus Told U.S. Executives No Broad Scope Warning Needed Despite Superbug Outbreaks

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Faced with superbug outbreaks in three countries by early 2013, Japanese device giant Olympus Corp. told U.S. executives not to warn American hospitals about potentially deadly infections from tainted medical scopes, internal emails show.

After two dozen infections were reported in French and Dutch hospitals, the company alerted European customers in January 2013 that a scope it manufactured could become contaminated.

A top Olympus executive in the U.S. grew concerned because the company was investigating a similar outbreak at a Pittsburgh hospital.

“Should [we] also be communicating to our users the information that [Olympus Europe] is communicating to their European users?” Laura Storms, vice president of regulatory and clinical affairs in Center Valley, Pa., asked in an email to Tokyo headquarters on Jan. 31, 2013.

No, that’s not necessary, said Susumu Nishina, the company’s chief manager for market quality administration in Tokyo in a Feb. 6, 2013, reply.

It is “not need[ed] to communicate to all the users actively,” Nishina wrote, because a company assessment of the risk to patients found it to be “acceptable.” However, he added that Storms should respond to questions from a customer.

Outbreaks of infection at hospitals in Los Angeles, Milwaukee, Denver and other cities followed over the next three years. All told, at least 35 people at U.S. hospitals have died since 2013 after suffering infections from contaminated gastrointestinal scopes manufactured by Olympus, according to hospitals and public health officials.

Olympus’ actions — and inaction — are being closely examined in lawsuits by American patients and their families who contend that the manufacturer was negligent and might have prevented the outbreaks and deaths had it been more forthcoming. In addition, federal prosecutors are investigating Olympus’ handling of the infections — and the emails could become crucial evidence in any future case.

The company’s internal emails, filed in a Pennsylvania court this month as part of a patient lawsuit, reveal conflicts inside Olympus over how to respond to a growing threat to patient safety, pitting U.S. executives against their superiors in Japan who had the final say.

Olympus, which controls 85 percent of the U.S. market for gastrointestinal scopes, declined to comment on the emails, citing the pending litigation. It also declined to discuss the ongoing investigation by the U.S. attorney’s office in New Jersey.

Storms, Nishina and other company officials named in the emails didn’t respond to requests for comment.

In a statement, the company said “patient safety is our top priority. The duodenoscope issue continues to receive the highest level of attention at Olympus, and we remain committed to working with the proper authorities and our stakeholders to understand and address the potential root causes.” The company declined to address why it didn’t feel it was necessary to inform U.S. hospitals when it was alerting those in Europe.

This story also ran in the Los Angeles Times. It can be republished for free (details).

At the time of the safety alert in Europe, Olympus was already aware that design flaws could make it difficult to clean its duodenoscope for the next patient. Used in about 700,000 procedures annually in the U.S., the snake-like device is put down a patient’s throat to diagnose and treat problems in the digestive tract such as cancers and blockages in the bile duct.

As the Los Angeles Times reported in December, an investigator hired by Olympus and a Netherlands hospital concluded in a June 2012 report that the scope’s design could allow blood and tissue to become trapped, spreading bacteria from one patient to another. The independent expert called on Olympus to conduct a worldwide investigation and recall all its scopes if similar problems turned up.

A Senate report released this year said Olympus knew about at least three outbreaks — at hospitals in the Netherlands, France and Pittsburgh — affecting an estimated 46 patients when the European alert went out in early 2013.

Inside Olympus, the debate about how to respond to the emerging outbreaks in the U.S. came to a head on Feb. 6, 2013, the emails show.

Just a few hours after her exchange with the Tokyo official, Storms was confronted by her own U.S. staff.

Donny Shapiro, a director of regulatory affairs for Olympus in San Jose, Calif., sent an email to Storms and seven other employees with “Duodenoscope safety recall??” in the subject line. He cited the problems in Europe and results from the company’s microbiology lab showing Olympus scopes had tested positive for bacteria at the University of Pittsburgh Medical Center.

“Why was the alert only issued in Europe?” Shapiro asked his colleagues.

Six minutes later, Storms wrote back: “Donny, [Olympus Japan] has determined that a global communication is not required.”

In these emails, Storms seemed to accept the decision by the corporate office. But in other messages to headquarters that same day, she challenged Japan executives’ handling of the investigation into the University of Pittsburgh Medical Center, or UPMC, outbreak. The hospital initially linked one contaminated scope to 18 sickened patients but later downgraded that total to one case.

In a follow-up email to Nishina, Storms questioned the company’s determination that the hospital was at fault by failing to clean the scopes properly — known as “insufficient reprocessing.”

“Can you please explain how OMSC [Olympus Japan] reached the conclusion that insufficient reprocessing was the cause for this MDR [medical device injury report]? Since OMSC was not on-site at UPMC and did not investigate this facility, how is OMSC reaching this conclusion?” she asked.

“Specifically what evidence does OMSC have that supports inadequate reprocessing by UPMC? You do not cite any objective findings, testing, etc. for this endoscope model,” Storms wrote.

Nishina replied that the company’s cleaning instructions work when followed and “no major observations were noted during the inspection” of the scope in question. In the emails, he discounted lab results showing bacterial growth on Olympus scopes, suggesting that contaminants could have been introduced during testing.

This became the company’s standard response in the U.S. after each outbreak over the next two years, according to federal injury reports, company documents and interviews with hospitals. Olympus contended that its scopes did not cause the infections and blamed the hospitals for not cleaning the reusable instruments properly. The company treated each case as an isolated incident, not telling hospitals about outbreaks elsewhere in the U.S.

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Pressure on the company increased in January 2014 when physicians representing the American Society for Gastrointestinal Endoscopy asked Olympus to fund testing at hospitals on the effectiveness of scope cleaning against antibiotic-resistant bacteria. Though Olympus months later contributed to the research, the initial response was cautious.

In Tokyo, Shigeki Okuno, who worked in regulatory affairs and quality assurance, expressed concern about getting a “negative result” due to improper testing procedures. Okuno suggested that the company have a hand in the testing by providing the data itself or working closely with the medical society.

In March 2014, an infection-control expert at the University of North Carolina’s School of Medicine raised more red flags in an email to Olympus, according to the correspondence filed in court.

William Rutala, a UNC professor of infectious diseases, notified the company that 40 percent of scopes tested at his academic medical center were contaminated, even after following the company’s cleaning protocol.

“This is a critical issue for U.S. hospitals to resolve/understand to ensure patient safety and I need your input,” Rutala wrote to Mary Ann Drosnock, head of infection control at Olympus in the U.S. at the time. “Despite substantial time and effort we have been unable to discover the exact cause of these positive cultures and implement a strategy to prevent contamination.”

Drosnock shared the information with officials at Olympus under the subject line “Urgent: Confidential.”

Rutala declined to comment for this story on the test results at North Carolina or the company’s response.

The U.S. Food and Drug Administration began looking into reports of scope-related infections in September 2013. By May 2014, the government investigation was intensifying and the agency requested information from Olympus on a “potential safety concern involving infections,” according to FDA records and the company emails.

Storms forwarded the notice to the Tokyo headquarters and labeled it “urgent.”

“I am respectfully requesting that [Olympus Japan] assign their best English writers to work on this letter draft,” she wrote in her email. “Please give this FDA letter urgent priority. This letter is a clear indication of the FDA’s concern.”

As Olympus carried out its decision not to warn American hospitals, the number of patient infections linked to dirty scopes continued to climb. Overall, as many as 350 patients at 41 medical facilities worldwide were infected or exposed to contaminated scopes made by Olympus or two other companies from January 2010 to October 2015, according to the FDA.

Eventually, in February 2015 — more than two years after Olympus first warned European hospitals — the FDA issued a safety alert saying that patients had become infected even when the manufacturer’s cleaning instructions were followed correctly.

At the same time, Olympus notified customers that it was aware of 95 infection complaints in the U.S. about its newest duodenoscope model, and the scope required “careful attention to cleaning.”

The FDA alert came one day after an outbreak was reported at the Ronald Reagan UCLA Medical Center. Three patients died and 12 more were sickened after being treated with Olympus scopes there, according to UCLA.

Olympus didn’t announce a U.S. recall of its duodenoscopes until January 2016 — two days after a congressional report criticized the company for failing to notify patients, doctors and hospitals sooner about a serious safety hazard.

The Olympus devices remain on the market and in use while the company recalls them for repairs. The recall is expected to be completed nationwide next month.

Some doctors and researchers say the problems will persist unless Olympus completely redesigns the duodenoscope to keep bacteria from becoming trapped in tiny crevices at the tip.

In the meantime, U.S. hospitals are trying a variety of new cleaning and surveillance methods to prevent more infections.

And patients are continuing to wage their legal fight against Olympus. The internal emails were filed in the pending Philadelphia County Court case of Daniel Nietzold, a patient in Gastonia, N.C.

Nietzold, who sued Olympus in February for negligence, said he was exposed to a contaminated scope during multiple procedures at Carolinas Medical Center in Charlotte between January 2013 and July 2015. The hospital declined to comment.

The company is fighting Nietzold in court, saying Nietzold had “failed to allege particular facts.” This month, the Philadelphia judge dismissed the Japanese headquarters as a defendant on jurisdictional grounds but allowed the case to proceed against the company’s U.S. unit.

Pete Kaufman, a Los Angeles attorney representing Nietzold and nearly 20 other patients in scope-related lawsuits around the country, said the internal documents show that Olympus knew patients were in jeopardy but chose not to act.

Charles McIntyre of Waxhaw, N.C., another Kaufman client, said he suffered a superbug infection after being treated with an Olympus scope in February 2015 at the Charlotte hospital. The 61-year-old auto mechanic, who sued the device maker earlier this year in Philadelphia, said he’s still struggling to regain his strength after spending much of last year in the hospital fighting the infection.

“Olympus had plenty of time to tell everybody in the U.S. that they had an issue with the scope,” McIntyre said. “I feel betrayed.”

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

Case Study: My Experience With Surrogates

What You Need to Know About Surrogate Mothers When it comes to having a child, it can be one of the most exciting and emotional experiences of your entire life. It may be one of the happiest times of your life, but it does come with a wealth of responsibilities that you and your companion must carry for your entire life. If you are incapable of bearing your own child, you now have the ability to work with various fertility treatments, as well as work with a surrogate mother of your choosing to assist with the process of carrying and birthing your child. Some of the reasons you may not be able to have your own kids include the following, but are not limited to: infertility, any type of physical disability or abnormality, and same-sex couples. If you and your partner desire to have kids, but cannot have them on your own for any of the reasons listed above, we are here to educate you on the various options available to you in terms of surrogacy. Many people may not know this already, but you have four different kinds of surrogacy options. We will begin by explaining traditional surrogacy. A traditional surrogacy involves the mother in your union being the genetic mother for your child. If you elect to have this type of surrogacy, it involves natural conception or conception through fertility treatments through intrauterine insemination and intracervical insemination, which will be handled at a fertility clinic and will be performed by doctors that you trust. You also have the option of gestational surrogacy, which is the use of a surrogate mother, who typically does not have a genetic link to you or your family, unless you are capable of having a family member carry for you, and happens when a doctor transfers an embryo of your eggs and your husband’s sperm into the uterus of surrogate mother. Couples’ third option is to pursue commercial surrogacy, which is when you hire a surrogate mother for compensation to carry and deliver a child. The final surrogacy option available to you is called altruistic surrogacy, and it involves a woman choosing to surrogate a child from another father for no payment, handing over care to you once she delivers the child. As you can see, there are many ways to deliver a child, that do not involve personal childbearing on your part. For couples who wish to bring kids into the world, but are unable to do so on their own for a number of reasons, it is nice to know you have a wealth of alternative options and treatments available to you, that will allow you to do so. Your final recommendation is to conduct an adequate amount of research before you make a decision!Why People Think Agencies Are A Good Idea

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Discovering The Truth About Wellness

Health: Some Basic Facts So what is health and why is health something that is so important? And even though health is something that is so important, many people actually do not even think about it until they get really sick or until they get injured. Health is such an important consideration and the definition for health is your social, your mental, and also your physical well being, so that is an important thing that you will want to make sure that you are able to keep into account of when you are talking about health. But now there are some other factors to think about as well including spiritual and emotional health, which are just as important. And each category of health is connected to one another, so when you are looking at one aspect of health, then you will also need to look at a different aspect as well, so that is an important consideration for you to keep into account. And there is many different solutions in order to solve a wide range of different kinds of health problems as well, so that is something you will want to make sure you are able to keep into account of as well. Health is touches every part of our lives and even though the treatments are different, we have to look at the larger picture because if someone’s health is not good in regards to emotion, then this can cause other kinds of issues as well, that are not very good such as getting hurt physically. Health is very important and there is so many things that you will have to keep into thought such as physical health, which is everything about your body so as you can imagine this is the kind of health that will be most talked about. Physical health is critical because this basically allows us to live normal lives and a lot of people are making sure that they have excellent physical health nowadays through diets or even through working out. If you are completely healthy, then this will basically mean that your organs and every other part of your body is working properly and in order to maintain this you will have to do exercise, you will need to eat right, and you will also need to get some good rest every night as well. Remaining in good health is a simple process but it can be challenging though, so just take that into mind. And that is the basic facts and the basic information that you may want to keep inside your mind of when it comes down to health.

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Medicare Prepares To Go Forward With New Hospital Quality Ratings

Despite objections from Congress and the hospital industry, the Obama administration said it will soon publish star ratings summing up the quality of 3,662 hospitals. Nearly half will be rated as average, and hospitals that serve the poor will not score as well overall as will other hospitals, according to government figures released Thursday.

The government says the ratings, which will award between one and five stars to each hospital, will be more useful to consumers than its current mishmash of more than 100 individual metrics, many of which deal with technical matters. The hospital industry, however, fears the ratings will be misleading and oversimplify the many types of care at the institutions.

The Centers for Medicare & Medicaid Services said it would release the ratings “shortly.” In a preemptive effort to rebut criticisms, it noted its analysis showed “hospitals of all types are capable of performing well on star ratings and also have opportunities for improvement.”

The stars are based on 64 individual measures of hospitals that are already public on the government’s Hospital Compare website. Those include mortality rates, the number of readmissions, patient opinions, infection rates and frequency of medical scans like MRIs.

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Medicare said that based on its current data, 102 hospitals would receive the best rating of five stars, 934 would get four stars, 1,770 would receive three stars, 723 would be awarded two-stars and 133 would get the lowest rating of one star. Another 937 hospitals would not be rated because the government did not have enough data to properly evaluate them.

“The star ratings provide people a broader picture,” Medicare officials said in a statement. “CMS used a similar approach to simplify complex quality information on other healthcare quality reporting websites, such as Nursing Home Compare, Home Health Compare, Dialysis Facility Compare and Medicare Plan Finder.”

The ratings factor in the mix of patients at a hospital, so those with a high proportion of sicker patients are not supposed to rate lower than those that handle more run-of-the-mill cases. The analysis showed hospitals of different sizes also did about the same, and critical access hospitals — small, mostly rural facilities — performed slightly better overall.

Medicare did not consider the relative wealth of patients. Its analysis showed hospitals serving large swaths of low-income people tended to receive lower star ratings. An analysis by Kaiser Health News of the hospitals that CMS rates shows 22 percent of safety-net hospitals were rated above average — four or five stars — compared with 30 percent of hospitals overall. Twenty-nine percent of safety-net hospitals were rated as below average, with just one or two stars, while 22 percent of other hospitals received those lower ratings.

Teaching hospitals also received lower scores on average. A third were rated with only one or two stars, while only a fifth of other hospitals received fewer than three stars, according to the KHN analysis. The teaching hospitals include large academic medical centers that often top the lists of best hospitals put together by groups like Healthgrades and U.S. News & World Report.

Dr. Janis Orlowski, an executive at the Association of American Medical Colleges, said the fact that so many prestigious hospitals fare poorly in the star ratings is a signal that Medicare’s methods are flawed.

“These are hospitals that everyone in the know tries to get into, so we need to be careful about the consequences, that this star rating can be misleading,” Orlowski said. “Putting the information out at this time is not in the patient’s interest.”

The American Hospital Association also expressed continued concerns.

The government originally planned to release the star ratings in April but postponed it after a majority of members of Congress echoed the industry’s concerns. Debra Ness, the president of the National Partnership for Women & Families, a nonprofit in Washington, urged Medicare to post the ratings before the end of the month.

“We believe great thought and care went into development of the Hospital Star Ratings Program,” she wrote on the group’s website. If needed, the program can be adjusted over time. But now is the time to move forward and give consumers a tool that will allow them to assess which hospitals do the best job of providing the care they need.”

Diabetes Linked To Risk Of Mental Health Hospitalization In Young Adults: Study

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Young people with diabetes were four times more likely to be hospitalized for mental health or substance use treatment in 2014 than were young adults without the disease, according to a recent study that shines a harsh light on the psychological toll the disease can take on this group.

For every 1,000 young adults aged 19 through 25 who had diabetes, 37 were hospitalized for mental health/substance use, compared to nine young adults without diabetes. The study by researchers at the Health Care Cost Institute also found the incidence of such hospitalizations is on the rise for these patients. The 2014 rate was 68 percent higher than two years earlier, when the rate of mental health/substance use hospitalizations per 1,000 for that group was 22.

“It was definitely not something that we were expecting,” said Amanda Frost, a senior researcher at HCCI, who worked on the recently published study. HCCI researchers will examine the trend more closely in future work, she said.

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The study analyzed the insurance claims of more than 40 million people younger than age 65 from 2012 through 2014 with work-place provided coverage from three major health insurers. No other age group showed such high rates of hospitalization for mental health or substance use, according to the study. The rate for children up to age 18 with diabetes was second highest, at 21 per 1,000 in 2014.

One possible contributor to the rise in hospitalizations may be the health law, which permitted young people to stay on their parents’ health insurance until they turn 26, said Frost.

In 2014, “we saw a big jump in employer-sponsored insurance coverage for those young folks,” she said. In addition, “we could see an increase in young adults’ mental health hospital admissions at that time.”

Depression is two to three times more common among young people with diabetes than those that don’t have the disease, said Tina Drossos, a clinical psychologist at the University of Chicago Medicine Kovler Diabetes Center.

Managing the disease is tough at any age, but young people may find it particularly challenging. “It’s a 24/7 disease,” she said, requiring kids to continually test their blood, monitor their carbohydrates, and take more insulin if their blood sugar gets too high. In contrast, some other chronic conditions require someone to take a pill once a day, nothing more.

Young people may feel their condition sets them apart. “Everybody wants to fit in, and this is something that doesn’t fit in,” she said, noting that young people with diabetes can be subject to bullying and teasing.

But that doesn’t explain the increase in hospitalizations for mental health issues, she said. Typically, young people would be hospitalized if they tried to commit suicide or had seriously entertained the idea of suicide and formed a plan to carry it out.

“Most people who are depressed don’t commit suicide,” she noted.

Please contact Kaiser Health News to send comments or ideas for future topics for the Insuring Your Health column.

Montana’s ‘Pain Refugees’ Leave State To Get Prescribed Opioids

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Federal authorities say about 78 Americans die every day from opioid overdose. In Montana, health care officials report that abuse there is worse than the national average. But the casualties of the opioid epidemic are not all drug abusers.

On a recent night, three Montana residents, who call themselves pain refugees, boarded an airplane from Missoula to Los Angeles. They say that finding doctors willing to treat chronic pain in Montana is almost impossible, and the only way they can get relief is to fly out of state.

Before Gary Snook dropped into his seat, he paused in the aisle, pressing his fingertips into his upper thigh. He bent his knees slightly and moved his hips side to side. He was getting in one final stretch before takeoff.

“My pain, it’s all from my waist down,” he said. “It’s like being boiled in oil 24 hours a day.” Snook has been taking opioids since he had spine surgery for a ruptured disk 14 years ago. After the operation, he says he was in so much pain he couldn’t work. He’s tried all kinds of things to get better.

“I got a surgery, epidural steroid injections, acupuncture, anti-inflammatories, physical therapy, pool exercises,” he said. “I’ve tried anything that anyone has ever suggested me to try. Unfortunately what I do right now is the only thing that works.”

This story is part of a partnership that includes Montana Public Radio, NPR and Kaiser Health News. It can be republished for free. (details)

Snook says though he might seem desperate like someone who is addicted to pain killers, he’s not. He’s not craving a quick fix. He leaves his home for treatment because he has no confidence in the doctors in Montana and he wants to be healed.

“I believe pain control is a fundamental human right, or at least an attempt at pain control,” he said. “To deny someone with a horrible disease like me access to pain medications is the worst form of cruelty.”

It was dark outside when Snook, his wife and the two other pain patients got off the plane in Los Angeles. They wheeled their suitcases to a rented SUV. When they got to the hotel, they smiled and greeted the lobby clerk by name.

The trip has become routine. Every 90 days, they come here to see a doctor who gives them the care and prescriptions they say they can’t get at home.

Fear Among Montana Doctors

Montana is a tough state to find many options for any medical care. Because much of the state is rural, residents often travel long distances, including out of state, for specialty care.

In the past several years, the Montana Board of Medical Examiners has taken on several high-profile cases of doctors it suspects of overprescribing opioids. At least two Montana doctors have had their licenses suspended since 2014.

Executive Officer Ian Marquand said his organization doesn’t play favorites. “The board does not encourage particular kinds of doctors, it does not discourage particular kinds of doctors. The door is open in Montana for any qualified, competent physician to come in and practice.”

But Marc Mentel acknowledged that there’s fear around prescription painkillers in Montana’s medical community. He chairs the Montana Medical Association’s committee on prescription drug abuse, and he said he does hear of doctors being more wary.

Mentel, who started practicing medicine in the 1990s, said that when he was training, medical education didn’t include treating long-term pain.

“The perfect tool, the perfect medicine that would take away a person’s pain and allow them to function normally does not yet exist,” he said. “So we are trying to use any tool, any means we can to help lessen the severity of their pain.”

Mentel said opioids do help some patients, but he hopes his generation of doctors will learn more about pain and understand ways to treat it beyond opioids.

In March, the Centers for Disease Control and Prevention published long-awaited guidelines that said opioids should be the treatment of last resort for pain, and if used, should be combined with other treatments such as exercise therapy.

“Patients are in pain,” Mentel said. “We don’t have great tools for them and we need to recognize that this is going to be a chronic-disease state. They may be in pain for the rest of their lives. So … how do we treat them without actually harming them?” he said.

The California Solution

For Snook, relief is found at a small strip-mall clinic in suburban Los Angeles run by Dr. Forest Tennant, a former Army physician who says he has consulted for the National Institute on Drug Abuse, the National Football League and NASCAR.

Tennant says that doctors need to specialize in pain management to reduce the risk of improperly prescribing opioids.

Tennant says that doctors need to specialize in pain management to reduce the risk of improperly prescribing opioids. (Corin Cates-Carney/Montana Public Radio)

He has about 150 patients, half of them from out of state.

Tennant says there are legitimate reasons to be concerned about opioids, and that’s why doctors need to specialize in pain management.

To an untrained physician, Tennant said, addicts and pain patients can look similar. “Doctors can get conned,” he said. “I think that it is true that we’ve had a lot of opioids that get out on the street, and people get them … whether it is heroin or a prescription opioid.”

But opioids can also help people, Tennant said. Because of that, he said, the drugs shouldn’t be stigmatized, but used responsibly.

“They are the last resort, when there is no other option. You don’t use them until everything else has failed,” he said.

Tennant is lobbying for a Montana bill to guarantee more access to opioids for pain patients, so people like Snook don’t need to travel so far for a prescription.

“Had I stayed in Montana, I would have killed myself,” said Snook. “I just want humanitarian care, and I get that in California.”

This story is part of a reporting partnership with NPR, Montana Public Radio and Kaiser Health News.

How A Caribbean Island Became Prime Source Of U.S. Zika Cases

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More than 1,400 Americans contracted Zika while traveling outside the U.S. this year and a Caribbean-island nation is one of the top destinations where they caught the virus.

Visitors to the Dominican Republic account for more than a fifth of the confirmed Zika cases in the U.S. through mid-July, according to data from state health departments. New York, Florida and California alone tally 304 cases linked to the country, the data show.

As Florida officials investigate what may be the first non-travel-associated case of Zika infection in the U.S., Kaiser Health News looked more deeply into the origins of the 1,404 travel-related cases reported by all states to the Centers for Disease Control and Prevention.

For most people, Zika causes flu-like symptoms. Pregnant women are considered especially at risk of the threat because Zika can cause severe birth defects, such as microcephaly.

The CDC does not break out the cases it tracks by country of origin — only by the infected person’s state of residency. It said in June that 48 percent of the travel-associated cases for all of 2015 and through May of this year originated in the Caribbean, 26 percent in Central America and 23 percent in South America. The cases numbered 591 at that time.

This KHN story also ran in the Miami Herald. It can be republished for free (details).

Data from the four health departments that have reported more than half of the national case total — New York state, New York City, Florida and California — provide additional detail.

More people who visited the Dominican Republic in 2016 returned with Zika than did U.S. residents who traveled to Puerto Rico, Colombia, Jamaica, El Salvador, Haiti, Guyana and Venezuela combined, the four departments’ figures show.

What’s the explanation? In part, it reflects travel patterns between people living in the U.S. with family members in the Caribbean nation, public health officials say.

“It’s not really tourists going back and forth,” said Chris Barker, a researcher in the School of Veterinary Medicine’s Department of Pathology, Microbiology and Immunology at the University of California, Davis.

Dominican Republic immigrants are the fifth-largest Hispanic group in the United States, numbering 960,000 in 2012, according to the Migration Policy Institute. Their highest population concentrations are in New York, New Jersey and Florida. Dominicans comprise New York City’s largest Hispanic group and “have a significant travel exchange with the Dominican Republic,” according to the city’s health department.

It counts 207 travel-associated cases linked to the republic, followed by 27 to Puerto Rico and 20 to Jamaica.

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“Dominicans, Puerto Ricans and Guyanese do not have a higher risk of transmission for Zika infection,” the department said in a statement. “The data we have released simply reflects New York City’s demographics and travel patterns.”

People who travel outside the U.S. to visit family tend to make longer visits and often stay in residential locations, instead of “more sanitized areas made for tourists,” and that may increase their chances of getting bitten by a Zika-infected mosquito, Barker said.

Travel-related Zika cases are a function of both travel volume and how active the virus is in countries being visited, according to Barker. “When there is a high level of both, that is where you have the most cases,” he said.

Knowing which countries account for the most Zika travel cases helps drive public education efforts, said Vicki Kramer, chief of the vector-borne disease section at the California Department of Public Health.

As in New York City and Florida, California’s Zika statistics are also linked to immigrant populations there. Of California’s 77 cases, the greatest numbers resulted from travel to El Salvador, Honduras and Guatemala, all countries where state residents go to see family and often make extended visits, Kramer said.

New York City’s Health Department said it has done “extensive outreach” to local communities with strong ties to countries where Zika is active.

“These data could mean that Dominican New Yorkers are paying attention and testing more than other groups, which, in a way, is encouraging for us,” a statement from the department said.

With a population of about 10 million, the Dominican Republic shares the island of Hispaniola with Haiti.

Comparing U.S. data with a dataset from an international public health group indicates many more American visitors to the Dominican Republic have contracted Zika than residents of the island. The Pan American Health Organization reports 101 locally acquired cases there.

Brazil’s cases — 64,311 in total — account for almost 80 percent of the Zika infections in the Western Hemisphere through July 14, according to the organization. The country is so vast that infections are more spread out than in other areas of Central and Latin America, Barker said.

Public health sources for Zika statistics for the same country can vary. Puerto Rico’s tally is 2,162 on the Pan American Health Organization’s site. The CDC reports 2,843 locally acquired cases.

But among American travelers to both Brazil and Puerto Rico, the numbers appear to be far smaller, according to KHN’s analysis.

Those figures show 80 travel-related cases linked to Puerto Rico and six to Brazil. Colombia was at 46 and El Salvador at 31.

Mike Pence’s Health Policy Record Is A Mixed Bag

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Indiana Gov. Mike Pence is in the spotlight this week as the man Donald Trump has picked to be his running mate. Pence’s decisions about health and health care in Indiana have drawn attention from within and outside the state. His record could be important in November, because Trump doesn’t have a legislative record at all.

Here’s a quick look at the governor’s history in terms of health policy in Indiana.

Medicaid Expansion

Pence has always been a vocal opponent of the Affordable Care Act, even after the federal law passed in 2010 and was upheld by the Supreme Court.

But when faced with the choice of whether to expand Medicaid to cover Indiana residents who earn incomes that are 138 percent or below the federal poverty level — a key part of the ACA — Pence made a compromise. He debuted a conservative-friendly version of the expansion, one that requires Medicaid recipients to pay a monthly contribution, based on income, into a health savings account. Recipients who miss a payment can be bumped to a lower level of coverage, or lose it entirely, for six months.

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Now, after a year and a half, the Healthy Indiana Plan, or HIP 2.0, has enrolled about 190,000 more people into health coverage.

Caitlin Priest, director of public policy at Covering Kids & Families of Indiana, said the plan has helped many people get health insurance for the first time in their lives.

“It’s really been a wonderful way to move the needle both on health care access and ultimately on long-term health outcomes,” Priest said.

Pence took criticism from the right for accepting a component of Obamacare, but his conservative tweaks to Medicaid have other Republican-led states looking at that model.

HIV Outbreak

Pence drew criticism from local and national infectious disease experts for his response to an urgent health crisis in Indiana. In February 2015, the state reported an outbreak of HIV in Scott County, blamed on opioid addiction and needle sharing.

It got so bad — growing to more than 80 cases in the month after the announcement, and more than 190 to date — that the CDC came to Indiana to investigate, and public health experts began calling for a needle exchange. At the time, syringe exchanges were illegal in the state and Pence was opposed to changing that, at first.

He later signed an emergency declaration allowing Scott County to start a needle exchange program. Rather than legalize such exchanges statewide, Pence signed a bill that forces counties to ask permission to start a needle exchange.

Only a few counties have done it, so far, because the process takes a lot of planning, local support and money, which the state doesn’t provide, said Carrie Lawrence, a researcher with the Rural Center for AIDS/STD Prevention.

“If you’re the health department with only two part-time staff, and a full-time health director, who’s going to do this, and when is it going to happen?” Lawrence said.

Public Health Budgets

The HIV crisis also brought some attention to Indiana’s lack of public health funding in general, Lawrence said.

“I think we are dealing with the consequences of the fact that that we don’t have a strong infrastructure for public health in the state,” she said.

As governor, Pence signed legislation that slashed Indiana’s budget for public health programs, despite the state’s many pressing public health problems. Indiana has a high smoking rate, high obesity rate, and high infant mortality rate. The state is ranked nearly last for both federal and state public health funding. According to Trust for America’s Health, Indiana spends just $12.40 per resident on public health. West Virginia, in contrast, spends more than $220.

As a member of Congress from 2001 to 2013, Pence voted against funding for health programs such as the State Children’s Health Insurance Program and the Prevention and Public Health Fund.

Abortion Access

As a congressman, Pence was an early advocate for defunding Planned Parenthood, and this year, women’s health advocates have clashed with him again.

In March, the governor signed a bill that’s been cited as one of the most restrictive in the U.S., barring abortion on the basis of disability, gender or race of the fetus. It also requires women to get an ultrasound at least 18 hours before the procedure and requires that the fetal remains be buried or cremated.

Some Indiana women responded by updating the governor’s office with (sometimes graphic) news on their menstrual cycles by phone and on social media with hashtag #periodsforpence. The social media backlash mirrors #periodsarenotaninsult, which took aim at Donald Trump last year.

The Indiana ACLU brought a lawsuit against the state’s abortion restrictions — and a judge has since blocked portions of that law. “What the state of Indiana has attempted to do here … grossly flies in the face of existing law,” saidACLU attorney Ken Falk.

This story is part of a reporting partnership that includes Side Effects Public Media, NPR and Kaiser Health News.

Frustrated You Can’t Find A Therapist? They’re Frustrated, Too

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There are a lot of people suffering from a mental health condition who need therapy. And there are a lot of therapists who want to help them. But both sides believe the insurance companies that are supposed to bring them together are actually keeping them apart.

Insurance companies, for their part, say there’s a shortage of therapists.

But it’s not that simple. Especially in urban areas, there are lots of therapists. They just don’t want to work with the insurance companies.

Take Michael Klein, a psychologist practicing in San Francisco for more than 20 years. He considers it his spiritual calling to help people calm their social anxiety and to help couples stop fighting and build trust.

“With the right kind of support, they blossom,” he said.

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Klein doesn’t accept insurance. In fact, nearly half of therapists in California don’t take insurance, according to a recent survey from the California Association of Marriage and Family Therapists. The same is true of psychiatrists. There are two reasons why, Klein says.

“One, because the reimbursement rates don’t provide a living wage,” Klein said. “You can’t own a home and drive a car and survive on what in-network providers pay you.”

Most insurance companies pay therapists in their networks between $60 and $80 per session. In the San Francisco area and Los Angeles, therapists say the market rate for therapy is more like $150 to $200 a session.

“The second thing is the paperwork. For an hour of psychotherapy you spend a half-hour on paperwork,” Klein said. “I got into this field because I don’t like paperwork,” he said, laughing.

On that first point — money — insurance companies acknowledge that they may have to raise their rates to attract more therapists, particularly in rural areas. But they also say it’s on therapists to compromise.

“I think it’s unrealistic to expect either the state of California taxpayers or for health plans to just pay providers whatever they ask to be paid,” said Charles Bacchi, CEO of the California Association of Health Plans, a trade group for the insurance industry.

“That’s not sustainable,” he continued. “So you’re either in the system, and you want to be part of our health care system. Or you want to do concierge service outside of it and just pretend our health care system doesn’t exist. That’s your choice as a provider. Our job is to find providers that are willing to be part of the solution and willing to provide coverage to those of low and moderate income.”

That’s exactly how San Francisco psychologist Jonathan Horowitz feels. He wants to take insurance, but he has hit roadblock after roadblock. He sent out 10 applications to insurance companies and got nowhere.

“I might knock on Cigna’s door and say, ‘Hey, are you guys accepting any new therapists in 94105?’ ” he said, referring to his ZIP code. “And they might say, ‘No, we’re not doing that. We’re totally full.’ ”

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The Business of Therapy

Six different companies told Horowitz their networks were full.

So even though a patient might call seven therapists in her insurance network and not be able to get an appointment, insurance companies are telling new and willing therapists that there’s no demand for them.

“I definitely think it’s to control costs,” Horowitz said. “That’s very clear.”

He says he tried for a year, and one company finally said yes. Sort of. Horowitz never got a formal notice saying his clinic was admitted to the network.

“It was just like, ‘Oh wait, it looks like we’re suddenly getting a couple referrals from them. I wonder if we’re in their directory,’ ” he explained.

They were. Sort of. The clinic was listed in the directory. But the therapists who work at the clinic weren’t approved yet, meaning there was no one who was allowed to see the clients calling the clinic.

So Horowitz tried to call the insurance company to clear things up. He tried many, many times. I sat with him during a recent attempt to navigate the automated phone system:

Insurance company automated attendant: First I’ll need your provider identification number. If you need a moment, say, hold on.

Horowitz: Hold on.

Sound familiar? Turns out therapists get the automated run around as much as patients do. Horowitz persevered.

Insurance company: OK, please say or enter your PIN.

Horowitz: My PIN? Is this my PIN?

He enters a few numbers.

Insurance company: I’m sorry I couldn’t find an account using the info you gave me. Do you already belong to the network?

Horowitz: I think so?

Insurance company: Sorry, yes or no.

Horowitz: Um, I don’t know … yes?

Insurance company: All right. And have you already requested a credentialing application?

Horowitz: Yes.

Insurance company: Sorry, could you repeat that?

These experiences didn’t bode well. “Honestly, I got a really bad feeling about it,” he said.

Horowitz figured, if this is what it’s like just finding out if he’s in the network, how’s it going to be when he has a problem with a claim?

“I could just see that getting out of hand really quickly,” he said. “So at that point we just said, do we really even want to do this?”

Furthermore, he says, the reimbursement rate was even lower than he expected, and the billing was so complicated that he was going to have to hire someone to do it. He says he couldn’t afford that.

“We made the decision that we’re just going to cancel the contract and continue to go with cash,” he said.

Easier said than done. Horowitz hasn’t been able to get through to anyone on the phone to cancel the contract. In the meantime, prospective patients are finding his name on the directory and are calling for appointments. Horowitz says he just has to say no.

This story is part of a partnership that includes KQED, NPR and Kaiser Health News.

Tracking Cancer In Real Time

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California is overhauling the way it collects information for its massive cancer database in the hope of improving how patients are treated for the disease.

Pathologists at a dozen hospitals in the state are part of a pilot project — the first of its kind in the United States — in which they are reporting cancer diagnoses in close to real-time to the California Cancer Registry. And they are using standardized electronic forms to make their reporting more consistent and accurate.

That represents a significant change for the registry, which traditionally relies on data up to two years old.

Physicians and researchers say the state’s partnership with St. Joseph Health in Orange County and UCSF Benioff Children’s Hospital in Oakland could become a model for cancer registries in other states. The changes in California are in line with Vice President Joe Biden’s “cancer moonshot,” which is intended, among other things, to facilitate cures through better data sharing, they said.

California’s registry, run by the state Department of Public Health, has amassed data on more than 4.5 million cancer patients since it began collecting information in 1988. It contains data on cancer diagnoses, including the type and extent of the cancer, screening, patient demographics, initial treatments and outcomes.

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If the cancer registry had current information from around the state, medical providers could see what treatments were most effective and make more informed and timely decisions with their patients, said Dr. Lawrence D. Wagman, executive medical director of the Center for Cancer Prevention and Treatment at St. Joseph Hospital in Orange. That, he said, could improve outcomes.

Eventually, doctors could also use it to direct patients to suitable clinical trials, said Michelle Woodley, chief nursing information officer at St. Joseph Health System.

“Our driving force is making sure we can get the patient to the right treatment, the right trials as quickly as possible,” she said.

Real-time reporting in cancer registries might eventually make it easier for doctors to obtain important information on their patients if they go to different places for radiology, oncology and surgery — or if they switch physicians or hospitals. Currently, however, the data does not include patients’ identities.

Researchers regularly use the California database to search for trends, confirm potential cancer clusters and identify disparities in screening and outcomes.

They’ve used the information to determine that cancer patients on Medi-Cal have lower survival rates than those privately insured, that the risk of childhood cancers may vary depending on where the mothers were born, and that the social benefits of marriage could help patients live longer.

State cancer registries across the nation report data to the Centers for Disease Control and Prevention, where it is compiled into an annual report used for research.

But pathologists and medical providers said the lack of consistency and timeliness of the registries in California and elsewhere limits their value in helping individual patients. Registries have been used primarily for research and surveillance of cancer trends based on historic data.

“The current system is not working as well as it should,” said Bob Achermann, executive director of the California Society of Pathologists. “There are long delays … You would assume that a program that has been around as long as it has would be more sophisticated, but it is not.”

State law requires hospitals and cancer centers to report nearly all cancer diagnoses to the state registry. Only about five percent of diagnostic data is currently being sent in real-time, but California health officials plan to expand that to as much as 10 percent by next June and 65 percent by 2022. The ultimate goal is for 100 percent of reporting to be in real time, though there is no specific time frame for achieving it.

Pathologists say the technological groundwork is already there, in part because of the electronic medical records used by most hospitals. But public health officials said that hospitals and cancer centers also may have to upgrade their information systems.

Assemblywoman Susan Bonilla (D-Concord) has proposed legislation that would require pathologists, beginning in 2019, to use an electronic medical record or a web portal when they report cancer diagnoses to the state registry. Currently, most pathologists report new diagnoses with written paragraphs about a patient, and specific information is pulled out of the text. Supporters of the bill argue that the registry needs to be updated so it can be used by oncologists making critical decisions about treatments.

The electronic reporting forms used by hospitals in the pilot project, developed by the College of American Pathologists, are checklists that ask for specific information about patients and their cancer diagnoses.

The checklists can be much more easily analyzed than written paragraphs about a patient, said Robert Hiatt, chair of the department of epidemiology and biostatistics at the University of California, San Francisco. “You don’t have to … try to interpret texts,” he said. “It is collecting data from the get-go that is standardized. That is a very good thing.”

The pilot project is a collaboration among the hospitals, the College of American Pathologists, software developer mTuitive Inc., and the public health department, which is the primary funder.

Having access to current and standardized data could change the way registries are used, said Samantha Spencer, director of structured reporting at the College of American Pathologists. In addition to being used for surveillance, the registries — a “warehouse of critical information” — could also improve patient care, she said.

“It is not just having the information,” Spencer said. “It is acting on it.”

California public health officials said they will be able to generate real-time surveillance statistics, identify cases for ongoing research and implement a statewide program to improve the quality of cancer treatment.

“The environment within health care provider organizations and specifically cancer reporting facilities has changed significantly in the last 10-plus years,” the California Department of Public Health said in a statement. “As technology in every aspect of our lives has drastically changed, so has the expectation of physicians, laboratories, facilities and facility groups about what types of data they need.”

Blue Shield of California Foundation helps fund KHN coverage in California.