Department Of Veterans Affairs To Pay For Robotic Legs

ReWalk Robotics service engineer Tom Coulter (right) looks on as paralyzed Army veteran Gene Laureano walks using a ReWalk device on Wednesday in the Bronx, N.Y.

ReWalk Robotics service engineer Tom Coulter (right) looks on as paralyzed Army veteran Gene Laureano walks using a ReWalk device on Wednesday in the Bronx, N.Y. Mel Evans/AP hide caption

toggle caption Mel Evans/AP

Eligible veterans with spinal cord injuries may soon be able to walk again.

The Department of Veterans Affairs will now pay for robotic leg devices for eligible paralyzed veterans, VA officials tell The Associated Press.

Dr. Ann Spungen, who led VA research on the device, told AP that the announcement represents a major shift in policy:

“The research support and effort to provide eligible veterans with paralysis an exoskeleton for home use is a historic move on the part of the VA because it represents a paradigm shift in the approach to rehabilitation for persons with paralysis.”

Previously, the $77,000 cost of the device was prohibitively expensive for many injured veterans.

This video from ReWalk, the company that developed and manufactured the robotic legs, shows how its “wearable robotic exoskeleton” works:

[embedded content]

This video from ReWalk, the company producing the robotic legs, shows how they work.

YouTube

The system allows people to stand upright and walk, and uses “wearable brace support, a computer-based control system and motion sensors,” ReWalk says in a statement. The FDA approved the system in 2014 for home use.

ReWalk says that the VA’s decision means that veterans with spinal cord injuries can seek referral and evaluation at training centers around the country. Once an individual receives training, they’ll be considered for a personal unit to use outside the center.

“The policy outlines a sound process to educate, train and importantly, to provide individual veterans with a ReWalk Personal device so that they may walk at home and in the community,” says ReWalk CEO Larry Jasinski in the press release from the company. “We expect this landmark national policy will substantially improve the health and quality of life of many veterans in the years ahead.”

But for most paralyzed veterans, there are more than just financial obstacles. NPR’s Amy Held reported for our Newscast unit that the ReWalk “only works for certain paraplegics who meet height and weight requirements.” That’s only a fraction of the tens of thousands of paralyzed vets, she says.

A ReWalk representative tells Held that the company has so far determined that 45 paralyzed veterans meet the criteria for the device and have begun the process of seeking enrollment in the program.

AP spoke with Gene Laureano, a 53-year-old veteran who was part of a study on the robotic legs. Now, he’s eagerly waiting for a response on his application for the system—and describes how much it meant to him during the study.

” ‘The tears came down,’ said Laureano, who was left paralyzed five years ago after falling off a ladder. ‘I hadn’t spoken to somebody standing up in so long.’

” ‘I just kept remembering the doctor told me it was impossible for me to walk, and then I crossed that threshold from the impossible to the possible.’ “

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Obamacare Enrollment Extended To Accommodate Last-Minute Demand

The deadline to buy health insurance under Obamacare has been extended for two days after high demand clogged the federal government’s exchange.

The Department of Health and Human Services announced Tuesday night, just hours before the original deadline of midnight Dec. 15, that consumers would have 48 hours more to buy a health plan.

Wait times to log in to HealthCare.gov or to get help on the telephone were so long earlier this week that officials said anyone who left a message or email address would be contacted after Tuesday’s deadline and would still be able to get insurance that goes into effect on Jan. 1.

By Tuesday, more than a million people had left telephone messages, so Department of Health and Human Services decided to give people more time.

Andy Slavitt, acting administrator of the Centers for Medicare and Medicaid Services, which oversees HealthCare.gov, said on Twitter that 185,000 people were simultaneously shopping for insurance late Monday.

People may be motivated by higher penalties that kick in next year for not having insurance.

In 2016, an individual who doesn’t buy insurance will owe at least $695 when filing taxes for that year. The fines increase based on income, and can go up to $2,085 for an individual.

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Hepatitis Drug Among The Most Costly For Medicaid

Solvaldi can cure hepatitis C, but the medicine carries a list price of $1,000 a pill. The typical 12-week course of treatment would cost $84,000.

Solvaldi can cure hepatitis C, but the medicine carries a list price of $1,000 a pill. The typical 12-week course of treatment would cost $84,000. Bob Ecker/MCT/Landov hide caption

toggle caption Bob Ecker/MCT/Landov

A drug that cures hepatitis C was one of the top pharmaceutical costs in most states’ Medicaid budgets in 2014.

All told, 33 states spent more than $1 billion to treat the disease with Gilead Sciences’ Sovaldi, according to data released Tuesday by Sens. Charles Grassley, R- Iowa, and Ron Wyden, D-Oregon. Still, the money spent was only enough to treat 2.4 percent of Medicaid patients infected with the virus.

New York spent the most by far. That state’s Medicaid program shelled out more than $360 million for Sovaldi to treat about 4,000 of its nearly 60,000 Medicaid recipients who have hepatitis C.

Pennsylvania was next, spending $98 million last year to treat 1,059 Medicaid recipients with hepatitis C. Another 30,000 Pennsylvanians are infected, the data show.

In a letter to the senators, Pennsylvania’s Secretary of Human Services said the state was suffering from “sticker shock” and said the price affected the state’s decision about whether to treat patients with the hepatitis drug.

“Treatment guidelines recommended prioritizing treatment for the ‘sickest’ patients due to potential costs and access issues,” said Secretary Theodore Dallas in the letter.

Many states also spent smaller amounts on Harvoni, Gilead’s other hepatitis drug, which was approved near the end of 2014.

When Solvaldi was approved in December 2013, it was the first drug that could effectively cure hepatitis C, a virus that attacks the liver and can lead to cirrhosis, cancer and the need for a transplant.

The Centers for Disease Control and Prevention estimated that 2.7 million people in the U.S. had chronic hepatitis C infections in 2013.

Sovaldi became the center of controversy when Gilead set the price at $1,000 a pill, or $84,000 for a course of treatment. Harvoni is even pricier.

In early December, Grassley and Wyden released a report from an 18-month investigation showing that Gilead was fully aware its pricing strategy would be controversial, but decided to stick with it to maximize revenue.

That report said sales of the two drugs since they were launched reached $20.6 billion as of September.

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Obamacare Sign-Ups Could Get A Bump As Higher Penalties Kick In

(Left to right) Martha Lucia, Bienvendida Barreno and Jorge Baquero went to a Miami mall in early November to discuss health insurance options with agents from Sunshine Life and Health Advisors.

(Left to right) Martha Lucia, Bienvendida Barreno and Jorge Baquero went to a Miami mall in early November to discuss health insurance options with agents from Sunshine Life and Health Advisors. Joe Raedle/Getty Images hide caption

toggle caption Joe Raedle/Getty Images

Tuesday is the last day to choose a health plan under the Affordable Care Act if you want insurance coverage to begin by Jan. 1. And officials who have spent the last two years using the carrot of persuasion to get people to buy insurance through the state or federal exchanges say the time has come for the stick.

That stick is a hefty fine.

Penalties for failing to buy insurance will roughly double. A family of four that makes $250,000 a year could face a fine when tax time rolls around in 2017 that approaches $10,000 if they don’t get coverage for 2016.

Kevin Counihan, CEO of the federal insurance exchange HealthCare.gov, says he thinks the high fines will induce people who didn’t have insurance before to at least shop around before deciding to skip coverage again.

Counihan, who was director of marketing for the Massachusetts health exchange 10 years ago, says it was when the fines approached $1,000 that sign-ups jumped.

“It got people’s attention,” he tells Shots. “And there seemed to be more of a discussion in their head about whether it made sense to pay the penalty and not get something for it.”

Research bears out Counihan’s theory. A study published in the American Economic Review in March showed that as fines got higher in Massachusetts, more people opted to buy insurance — and overall medical well-being of that population improved.

In 2016, an individual who doesn’t buy insurance will owe at least $695. The minimum fine for 2015 is only $325. The 2016 penalties could reach the thousands — from as much as 2.5 percent of their income, up to as much as the average annual price of a “bronze-plan,” the lowest-cost health plan available on the insurance exchange.

The Department of Health and Human Services, which runs HealthCare.gov, tried to make as many people aware of the fines last year as it could, without giving too much of a sting to those who didn’t buy plans. The agency allowed people who owed money because they didn’t have insurance in 2014 to sign up for 2015 insurance during a special enrollment period.

Counihan says people shouldn’t plan on another such reprieve.

“We’re not offering that this year,” he says. “The deadline for enrollment is Jan. 1. That’s a solid deadline.”

If you want insurance that kicks in on Jan. 1, however, you have to enroll Tuesday.

That means insurance navigators — the people who help consumers choose a health plan — are busy explaining the fees to consumers.

Katie Nicol is senior manager of public benefits and insurance navigation at Whitman-Walker Health, an LGBT-focused health center in Washington, D.C. She oversees 11 full-time navigators, and says many of the clinic’s clients are shocked to hear how big the penalties are to be for 2016.

“People understand generally that there’s a penalty,” Nicol says. “But the majority of the time they don’t know what that means — definitely not the amount of money that it is. There is a bit of shock of realizing, ‘Wow, if I don’t do this, I will likely be responsible for over $600 in penalties.”

Many of Whitman-Walker’s patients qualify for Medicaid. But because the health center is located in a rapidly gentrifying neighborhood, it also has many clients who are young and single professionals. Doctors, nurses and pharmacists at the clinic refer all their patients without insurance to in-house navigators to help them pick a health plan and enroll.

These navigators try to explain all the costs a patient will face, depending on whether they choose insurance and what type.

“It’s not just about the penalty,” Nicol says. “It’s also [about whether] you need prescriptions, if you need medical care. It’s almost doing a cost-benefit analysis.”

Leighton Ku, who directs the Center for Health Policy Research at George Washington University, says the stakes in 2016 go beyond any one individual’s costs.

“There’s information that clearly shows that the creation of the insurance mandates and the tax penalties bring more people into the insurance market,” Ku says. “That helps bring insurance costs down.”

Bringing down the overall costs of health plans will take time however, he says. In the meantime, the monthly premiums for health plans that take effect on Jan. 1 have gone up — an average of about 7.5 percent over the monthly premiums in 2015.

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You Can Buy Insulin Without A Prescription, But Should You?

Carmen Smith now gets the insulin she needs via her doctor's prescription. When she lacked health insurance, buying a version of the medicine over the counter was cheaper, she says. But it was hard to get the dose right.

Carmen Smith now gets the insulin she needs via her doctor’s prescription. When she lacked health insurance, buying a version of the medicine over the counter was cheaper, she says. But it was hard to get the dose right. Lynn Ischay for NPR hide caption

toggle caption Lynn Ischay for NPR

If you need insulin to treat your diabetes, that usually means regular checkups at the doctor’s office — to fine-tune the dosage, monitor blood-sugar levels and check for complications. But here’s a little known fact: Some forms of insulin can be bought without a prescription.

Carmen Smith did that for six years when she didn’t have health insurance, and didn’t have a primary care doctor. She bought her insulin without a prescription at Wal-Mart.

“It’s not like we go in our trench coat and a top hat, saying, ‘Uh I need the insulin,’ ” says Smith, who lives in Cleveland. “The clerks usually don’t know it’s a big secret. They’ll just go, ‘Do we sell over-the-counter insulin?’ “

Once the pharmacist says yes, the clerk just goes to get it, Smith says. “And you purchase it and go about your business.”

But it’s still a pretty uncommon purchase.

Smith didn’t learn from a doctor that she could buy insulin that way. In fact, many doctors don’t know it’s possible. When she no longer had insurance to help pay for doctors’ appointments or medicine, Smith happened to ask at Wal-Mart if she could get vials of the medicine without a prescription. To figure out the dose, she just used the same amount a doctor had given her years before.

Smith keeps the tools for controlling her diabetes in this kit, which contains metformin, syringes, fast-acting insulin for daytime use and slow-release for overnight.

Smith keeps the tools for controlling her diabetes in this kit, which contains metformin, syringes, fast-acting insulin for daytime use and slow-release for overnight. Lynn Ischay for NPR hide caption

toggle caption Lynn Ischay for NPR

It was a way to survive, she says, but no way to live. It was horrible when she didn’t get the size of the dose or the timing quite right.

“It’s a quick high and then, it’s a down,” Smith says. “The down part is, you feel icky. You feel lifeless. You feel pain. And the cramps are so intense — till you can’t walk, you can’t sit, you can’t stand.”

Smith says her guesswork put her in the emergency room a handful of times over the years.

The availability of insulin over the counter presents a real conundrum. As Smith’s experience shows, without training or guidance from a health care provider, it can be dangerous for a patient to guess at the best dosage and timing from version to version of insulin. On the other hand, being able to afford and easily buy some when she needed it may have saved her life.

There are two types of human insulin available over the counter; one made by Eli Lilly and the other by Novo Nordisk. These versions of the medicine are older, and take longer to metabolize than some of the newer, prescription versions; they were created in the early 1980s, and the prices range from more than $200 a vial to as little as $25 dollars, depending on where you buy them.

Dr. Jorge Calles, an endocrinologist at MetroHealth, Cleveland’s public hospital, is alarmed to think that some people are self-medicating with any sort of insulin.

“It’s a very serious situation if they are selling it over the counter — without any control with a prescription, specifically,” Calles says.

According to the medical consulting firm IMS Health, about 15 percent of people who buy insulin in the growing U.S. diabetes market, purchase it over the counter without a prescription.

The U.S. Food and Drug Administration declined multiple requests by NPR for an interview on this topic. But, in an email, an FDA representative said that the versions of insulin now available over the counter were approved for sale that way because they are based on a less concentrated, older formulation, “that did not require a licensed medical practitioner’s supervision for safe use.”

The broader availability of this form of insulin allows patients with diabetes to obtain it “quickly in urgent situations, without delays,” the FDA says, and is intended to increase patient safety.

Still, some people with diabetes, as well as some doctors, doubt that the benefits of that greater availability outweigh the risks, especially for patients who switch from one type of insulin to another without telling their doctor.

“This is not something that should be done without the help of a professional,” says David Kliff, who has Type 1 diabetes, and writes the Diabetic Investors blog. Kliff has followed and written about the expanding business of diabetes for years.

FDA officials are “basically sticking their heads in the sand” on this issue, Kliff says, and making a lot of assumptions.

“They look at insulin as a drug,” he says, “and say, ‘There’s this enormous body of evidence that shows that the drug is safe.’ But, you know, there’s a little asterisk at the end there. What the little asterisk basically says is: ‘You know, that’s assuming that the patient is trained on it.’ “

When asked about safety concerns, the FDA told NPR that the agency welcomes more research into the safety of over-the-counter insulin.

One state does require prescriptions for all insulin. Dr. Kevin Burke, a health officer for Clark County, Ind., led the effort to require prescriptions in his state.

“I didn’t realize that insulin was over the counter in Indiana until two of my patients, who were in good control, suddenly had increased glucoses,” Burke says. He asked them if they had changed their diet, lost weight, altered their workout routines. They had not.

“They both admitted that they had decided to switch to over-the-counter insulin,” Burke says, “which was different from what I had prescribed.”

Over time, taking the wrong dosages destroys your body, Burke says. Poorly managed diabetes is the cause of a host of complications, such as high blood pressure, kidney disease, nerve damage, loss of eyesight and stroke.

Burke says he took his concerns to the American Medical Association. But the national doctor’s association told him there are no data showing that the drug’s over-the counter availability is a public health hazard. In fact, the AMA’s board noted, getting insulin without a doctor’s prescription may be an important way for some insulin-dependent patients to get access to the medicine they need.

Dr. Todd Hobbs is chief medical officer of Novo Nordisk in North America, which makes Novolin, one of the two versions of insulin sold over the counter. His company partners with Wal-Mart to sell its version under the brand name ReliOn. (Wal-Mart declined to be interviewed for this story.)

Hobbs says Novo Nordisk’s version of insulin is for people who don’t have insurance, or who have to pay a lot for their other prescriptions — “people who just, for whatever, reason have fallen through the cracks and either don’t have insurance coverage at the time, or are without coverage.”

With ever-rising copays and premiums, he says, many patients are turning to nonprescription insulin because it’s cheaper and all they can afford.

“But we hope to try to help them to not have to do that,” Hobbs says.

“We clearly think the newer versions are more close to what the body would do on its own,” he says. The prescription versions are better and safer, he agrees, because they make it easier for patients to avoid wild fluctuations in blood sugar.

Carmen Smith doesn’t blame the insulin she was taking for her emergency room visits.

“Insulin is not the problem,” she says. “It is getting the insulin that is the problem. Once I got connected with my physician, life as a diabetic got a lot less complicated for me.”

Smith is now on Medicaid. She has a doctor — and a prescription for one of the newer generation of insulins.

This story is part of NPR’s reporting partnership with WCPN ideastream and Kaiser Health News.

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California Expands Substance Abuse Treatment For Low-Income Residents

After years fighting a heroin addiction, Danny Montgomery, 33, is receiving inpatient treatment that is being paid for by Los Angeles County.

After years fighting a heroin addiction, Danny Montgomery, 33, is receiving inpatient treatment that is being paid for by Los Angeles County. Anna Gorman/KHN hide caption

toggle caption Anna Gorman/KHN

California is overhauling its substance abuse treatment system for low-income people, embarking on a massive experiment to create a smoother path for addicts from detox through recovery.

The state is the first to receive federal permission to revamp drug and alcohol treatment for beneficiaries of Medicaid, known as Medi-Cal in California. Through what’s known as a drug waiver, state officials will have new spending flexibility as they try to help people get sober and reduce social and financial costs of people with substance abuse disorders.

Under the waiver, the state plans to expand treatment services, including inpatient care, case management, recovery services and added medication. Beginning next year, drug treatment centers will be able to get reimbursed for providing this much wider range of options to people on Medi-Cal.

Only a small fraction of low-income Californians with substance abuse disorders receive treatment, largely because of restrictions on what Medicaid will pay for.

“This was a long time coming,” said Keith Lewis, executive director of Horizon Services, which provides treatment in San Mateo, Santa Clara and Alameda counties. “It’s a win/win for people with substance use issues and their families … and for the people providing those services.”

The changes, which will be phased in starting next year, stem in part from the Affordable Care Act, which required that substance abuse treatment be covered for people newly insured through Medicaid or insurance exchanges. The health law allowed states to expand Medicaid to cover millions more people.

Drug rehabilitation providers say the changes will give addicts a better chance at getting — and staying — clean. But they fear the state won’t raise the traditionally low Medi-Cal reimbursement rates for treatment, making it harder to provide services and produce the outcomes California is hoping for.

Lewis, of Horizon Services, said that under the waiver he expects drug treatment services to be higher quality and the workforce better trained. But he said that “Medi-Cal rates, which have always been too low, have to go up.”

California’s Medi-Cal drug treatment program currently costs about $180 million annually, paid through a combination of state and federal funds. There aren’t any estimates for costs under the new approach. But the idea is that the changes will help health care expenses overall by enabling more people to get sober and healthier so they stop rotating through treatment centers, jails and hospitals.

Nearly 14 percent of Medicaid recipients are believed to have a substance abuse disorder, according to the National Survey on Drug Use and Health.

The five-year pilot project in California was approved by the federal Centers for Medicare & Medicaid Services in August. Under the waiver, counties will approve treatment for Medi-Cal patients based on medical necessity and criteria established by the American Society of Addiction Medicine.

The Tarzana Treatment Centers in Los Angeles County provide outpatient and inpatient care substance use disorders.

The Tarzana Treatment Centers in Los Angeles County provide outpatient and inpatient care substance use disorders. Anna Gorman/KHN hide caption

toggle caption Anna Gorman/KHN

Current federal rules limit drug treatment centers’ ability to get reimbursed under Medicaid for residential care. Clinics with more than 16 beds essentially cannot get paid, except for treating pregnant and postpartum women. That restriction will be dropped for California under the waiver.

As a result Medi-Cal beneficiaries will be able to access up to two 90-day residential stays each year, with the possibility of one 30-day extension if providers determine that it is medically necessary. Certain populations, including those in the criminal justice system, can get approval for longer stays.

The waiver is also designed to provide better coordination between physical, mental health and substance abuse services,” according to John Connolly, deputy director of substance abuse prevention and control for the Los Angeles County Department of Public Health. That along with more access could result in fewer emergency room visits and hospitalizations, he said.

That’s potentially good news for people like Caitlin Knoles, a resident of Orange County who says she gets turned down for treatment of her methamphetamine addiction every time she tells residential centers she’s on Medi-Cal. She has ended up in the hospital more than once because of her addiction.

“It’s hard,” Knoles said. “I can’t get help.”

The only way she can reliably get clean now is in jail, she says.

“It’d be nice to have a job and have my family back and just be normal,” said Knoles, 24, as she sat outside a liquor store in Laguna Hills.

For the first time, substance abuse disorders will be treated like a disease rather than a short-term illness, said Marlies Perez, chief of the substance use disorder compliance division for the state Department of Health Care Services. “Even though we know it’s a chronic condition, we have treated it acutely,” she said.

Much depends, however, on reimbursement rates, which are still being negotiated. Clinic officials say they need higher rates to expand services and handle the anticipated influx of clients, many of whom will be seeking rehab for the first time.

“There is a cost to raising the bar on treatment,” said Albert Senella, president of the California Association of Alcohol and Drug Program Executives. “If the rates aren’t adequate … we are not going to be able to effectively meet the [new requirements] and the needs of the population.”

Senella, who is also CEO of Tarzana Treatment Centers in Tarzana, Calif., said many clinics across the state don’t have money to prepare for the overhaul, which will require improving technology and adding and training staff. For now, no plans are in place to provide counties or clinics with startup funds.

Eli Veitzer, interim CEO of Prototypes, which provides treatment services in Los Angeles, Orange and Ventura counties, said the waiver provides an “incredible opportunity” to transform care.

But in addition to fears about rates, Veitzer said he is also worried that 90 days of residential treatment won’t be enough for many people. Someone may be able to stem their addiction in three months but will still need more time in a treatment facility to prepare for life outside.

“If their ability to function independently in the community is not addressed, they are likely to relapse,” he said.

Danny Montgomery, a 33-year-old patient at Tarzana Treatment Centers, said he needed more than a few months to get clean after nearly a decade on heroin. The addiction, which he estimated cost him up to $100 a day, caused him to lose his job and nearly lose his family.

“The whole thing is a process,” said Montgomery, who lives in the San Fernando Valley. “You get the substance removed from your body, but you have to retrain your mind.” Montgomery said he tried to get a bed in a residential treatment center but couldn’t find one that would take Medi-Cal.

He tried to get clean on his own but it never lasted. Months after beginning his search, Montgomery was finally able to get a spot at Tarzana. He said Los Angeles County is paying for his stay, which began in May.

As worried as they are about reimbursements, clinic operators said a big advantage of the new approach is that it could help stabilize their funding. Providers now depend largely on counties to pay for residential treatment for low-income residents.

“You always suffered the vagaries of the budget cycle,” said Vitka Eisen, CEO of HealthRIGHT 360, which provides drug treatment in the Bay Area.

The waiver also means increased oversight of treatment centers.

Last year, a state audit found widespread fraud and questionable billing among Medi-Cal drug treatment providers. The audit followed reports by the Center for Investigative Reporting that clinics were billing for fake clients.

The new system will include more levels of accountability, Perez says, including more stringent requirements for clinics and more local control over contracting.

Knoles, who is addicted to methamphetamine, said she hopes that more people like her will be able to get treatment.

“I’ve had a lot of friends die from addiction,” she said. “Imagine if they’d gotten the help they wanted and needed. Things would have been different.”

Anna Gorman is a reporter with Kaiser Health News, a nonprofit news organization covering health care policy and politics. A version of this story appeared on KQED’s State of Health blog.

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Limits Urged On The Use Of Codeine To Stop Kids' Coughs And Pain

Cessation of breathing is a rare, but serious risk for some children who take cough syrup or painkillers that contain codeine, research shows. Advisers to the FDA say no one under 18 should take the drug.

Cessation of breathing is a rare, but serious risk for some children who take cough syrup or painkillers that contain codeine, research shows. Advisers to the FDA say no one under 18 should take the drug. iStockphoto hide caption

toggle caption iStockphoto

Medical advisers to the Food and Drug Administration say that prescription drugs containing codeine should not be used to treat children or the majority of teens suffering from pain or a cough.

In their meeting Thursday, the advisers also voted overwhelmingly against the over-the-counter sales of codeine-containing cough syrup for children. Selling such products without a prescription is currently permitted in 28 states and the District of Columbia.

The votes to restrict codeine’s use among children came at the end of a daylong joint meeting of the FDA’s Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, in Silver Spring, Md. The FDA does not have to follow the recommendations of its advisory committees, but it usually does.

“My concern, were I to be prescribing codeine in children, would be that I would, frankly, kill them,” said pharmacist Maria Pruchnicki, of the Ohio State University College of Pharmacy.

Several committee members noted that there are questions about whether codeine is even effective for alleviating children’s coughs, and whether there are potentially safer alternatives for alleviating pain.

Although the administration of products containing codeine to children has dropped sharply over the past decade, doctors often still prescribe medicines that contain the drug, and parents can buy cough remedies that include codeine without a prescription in many parts of the country.

Codeine combined with other painkillers, such as acetaminophen, is also commonly used to alleviate kids’ pain in a variety of situations, such as when they’re recovering from surgery.

But the FDA has been increasingly concerned because codeine has been found to trigger life-threatening breathing problems in some children.

Such complications seem to be fairly rare, but they do occur — especially among children whose bodies are genetically predisposed to quickly convert codeine into morphine.

The FDA convened the panel of outside experts to advise the agency on what action to take, if any, in restricting the drug’s use.

During the daylong hearing, FDA scientists made presentations on dozens of frightening cases in which children stopped breathing after getting codeine, including at least two dozen deaths in the last decade.

Also, representatives from the American Academy of Pediatrics , and the National Center for Health Research, an advocacy group in Washington, D.C., urged the FDA to follow the lead of regulators in Europe, Australia and Canada, who have sharply restricted the drug’s use.

“The use of codeine or any other opioid cannot be recommended for the treatment of cough in children,” said Dr. Constance Houck, an anesthesiologist at Boston Children’s Hospital, speaking on behalf of the academy. The pediatricians’ group recommended against using codeine for pain, and urged the FDA to bar the sale of products containing the drug without a prescription.

The Consumer Healthcare Products Association, which represents companies that make over-the-counter codeine products, urged the FDA to base any decision “on sound scientific evidence.”

The manufacturers’ association reminded the agency that codeine had been deemed earlier “to be generally recognized as safe and effective,” and any decision to remove codeine from over-the-counter sales should go “thorough a multi-step process.”

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Medicare Penalizes 758 Hospitals For Safety Incidents

In response to Medicare's penalty program, UCLA Health has focused on decreasing the use of catheters at its hospitals, including at Ronald Reagan UCLA Medical Center in Los Angeles.

In response to Medicare’s penalty program, UCLA Health has focused on decreasing the use of catheters at its hospitals, including at Ronald Reagan UCLA Medical Center in Los Angeles. Wikipedia hide caption

toggle caption Wikipedia

The federal government is penalizing 758 hospitals with higher rates of patient safety incidents, and more than half of those places had also been fined last year, Medicare records released late Wednesday show.

Among the hospitals getting punished for the first time are some well-known institutions, including Stanford Health Care in Northern California, Denver Health Medical Center and two satellite hospitals run by the Mayo Clinic Health System in Minnesota, according to the federal data.

The fines are based on the government’s assessment of the frequency of several kinds of infections, sepsis, hip fractures and other complications. Medicare will lower all its payments to the penalized hospitals by 1 percent over the course of the federal fiscal year, which runs through September 2016. In total, Medicare estimates the penalties will cost hospitals $364 million.

The penalties, created by the 2010 health law, are the toughest sanctions Medicare has taken on hospital safety, and they remain contentious. Patient safety advocates worry the fines are not large enough to alter hospital behavior and that they only examine a small portion of the types of mistakes that take place. Medicare plans to add more types of conditions in future years.

“I think the penalties are important,” said Helen Haskell, a prominent patient advocate. “I think it’s the only thing that gets people’s attention. My concern is the measures stay strong or even be strengthened.”

Hospitals say the penalties are counterproductive and unfairly levied against places that have made progress in safety but have not caught up to most facilities. They are also bothered that the health law requires Medicare to punish a quarter of hospitals each year.

“What bothers me the most is when people are improving and get that penalty, that’s money that could be invested into better care,” said Dr. Mark Jarrett, chief quality officer for the North Shore-LIJ Health System on Long Island, which had two hospitals penalized this year. “Taking the money away, all you’ve done is to make it harder for hospitals to function.”

The penalties are one prong of the Affordable Care Act’s mandate to leverage taxpayer dollars to improve hospital quality. Each year, Medicare also docks the pay of hospitals with too many patients coming back within a month, and it doles out bonuses and penalties to hospitals based on patient satisfaction scores, death rates and other performance measures.

Nonetheless, Medicare payments to most hospitals continue to be based primarily on the number and nature of the services they conduct, a system that health care experts say encourages hospitals to perform more procedures and focus on complex—and lucrative—ones.

“For hospitals, complications are still profitable,” said Dr. Martin Makary, a pancreatic surgeon and researcher at Johns Hopkins Medicine in Baltimore who studies safety. “Much of what we do in health care still has the incentives aligned the wrong way.”

This second round of the Hospital-Acquired Condition Reduction Program was based on the government’s assessment of the frequency in 2013 and 2014 of infections in patients with central lines inserted into veins, urinary catheters and incisions from colon surgeries and hysterectomies. Those infection rates account for 75 percent of Medicare’s evaluation.

The rest is based on eight other complications, such as surgical tears, collapsed lungs, broken hips and reopened wounds between July 2012 and June 2014. Most of these complications were part of last year’s penalty assessments, but the infections from colon operations and hysterectomies were added to the calculations this year.

In practice, only about 1 in 6 hospitals is being penalized because Congress exempted veterans hospitals, children’s hospitals and so-called critical access hospitals, which are generally the sole providers in their area.

In releasing the numbers, Medicare said average hospital performance improved for two of the three measures that the government relied on for the penalties both last year and this year. Infections from catheters used to collect urine from patients who aren’t mobile increased slightly over the year.

The HAC penalties have come under criticism by the hospital industry and researchers. A paper in JAMA, in the Journal of the American Medical Association examined the first year of the program and found that the hospitals that were penalized were more likely to have characteristics usually associated with quality. These included accreditation by The Joint Commission, the presence of the most extensive types of trauma centers and more nurses per patient.

Daron Cowley, a spokesman for Intermountain Healthcare in Salt Lake City, said in a statement that the penalty evaluation is “flawed and there are clearly refinements and changes needed.” Intermountain’s flagship hospital in Murray, Utah, has been penalized both years. Cowley said the penalty assessments don’t properly consider the “substantial variations in size and number of procedures performed” by different hospitals.

Another paper published in May in the American Journal of Infection Control suggested that while health experts recommend hospitals use urinary catheters as rarely as possible to limit the chance of infections, those same hospitals may look worse because the catheters are mostly used in the sickest patients, who are more prone to infections.

A number of hospitals, such as those run by UCLA Health, have focused on decreasing the use of catheters in response to the penalty program. Both UCLA Medical Center, Santa Monica and Ronald Reagan UCLA Medical Center were penalized this year. Dr. Robert Cherry, chief medical and quality officer of UCLA Health, said in a statement that infection rates decreased this year.

A total of 407 hospitals were penalized both years of the program. (A full list of all penalized hospitals can be viewed here.)

Dr. Ashish Jha, a Harvard researcher, said the penalties are only based on a fraction of the types of medical problems patients can experience. “The most common cause of problems in hospitals is medication errors, which remain absent from this program,” he said. “Ultimately unless we get to clinically based, validated measures of patient safety, we’re not going to be able to move the needle.”

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Celebrities' Medical Records Tempt Hospital Workers To Snoop

A bandaged George Clooney seen in New York in 2007, after he was injured in a motorcycle accident.

Improper access to the medical information of celebrities and people in the news has been a bane of health systems around the country for years. The proliferation of electronic medical records systems has made it easier to track and punish those who peek in records for no legitimate reason.

Below is a partial list of high-profile breaches and the consequences that followed, compiled from news reports.

Celebrity Medical Record Breaches

  • October 2007

    A bandaged George Clooney seen in New York in 2007, after he was injured in a motorcycle accident. Robert Pitts/Landov hide caption

    toggle caption Robert Pitts/Landov

    Palisades Medical Center in New Jersey suspended 27 workers without pay for a month for looking at the medical records of actor George Clooney, who had been treated there after a motorcycle accident.

  • March 2008

    Britney Spears was taken to the neuropsychiatric section of the UCLA Medical Center on Jan. 31, 2008.

    Britney Spears was taken to the neuropsychiatric section of the UCLA Medical Center on Jan. 31, 2008. Valerie Macon/Getty Images hide caption

    toggle caption Valerie Macon/Getty Images

    UCLA Medical Center took steps to fire at least 13 employees and suspended at least six others for snooping in the medical records of pop star Britney Spears during her hospitalization in its psychiatric unit. In addition, six physicians faced discipline.

  • November 2008

    Jacksonville Jaguars player Richard Collier joins his teammates on the sidelines for the national anthem on Dec. 18, 2008.

    Jacksonville Jaguars player Richard Collier joins his teammates on the sidelines for the national anthem on Dec. 18, 2008. Phil Coale/AP hide caption

    toggle caption Phil Coale/AP

    Jacksonville Medical Center in Florida fired 20 workers for looking at the records of Richard Collier, then an offensive tackle for the Jacksonville Jaguars, who was paralyzed in a shooting.

  • March 2009

    Nadya Suleman was dubbed "Octomom" after the birth of her octuplets.

    Nadya Suleman was dubbed “Octomom” after the birth of her octuplets. Barcroft Media/Landov hide caption

    toggle caption Barcroft Media/Landov

    Kaiser Permanente revealed that 21 employees and two doctors inappropriately accessed the medical records of Nadya Suleman, who gave birth to octuplets at its Bellflower, Calif., hospital. Of those workers, 15 were either terminated or resigned under pressure. Eight faced other disciplinary actions. In May 2009, the California Department of Public Health fined the hospital $250,000 for failing to protect Suleman’s records.

  • October 2009

    Guy Cannady, father of Little Rock television news anchor Anne Pressly who was attacked in her home, speaks about his daughter's condition on Oct. 24, 2008.

    Guy Cannady, father of Little Rock television news anchor Anne Pressly who was attacked in her home, speaks about his daughter’s condition on Oct. 24, 2008. Danny Johnston/AP hide caption

    toggle caption Danny Johnston/AP

    An Arkansas doctor and two former workers at St. Vincent Medical Center were sentenced to probation and fined after pleading guilty to federal misdemeanor charges that they illegally accessed the records of a Little Rock television news anchorwoman who died in 2008 after being attacked at her home during a robbery.

  • June 2010

    Police tape hangs across the street near the emergency room dock at UCLA Medical Center in Los Angeles, where Michael Jackson was brought after he stopped breathing.

    Police tape hangs across the street near the emergency room dock at UCLA Medical Center in Los Angeles, where Michael Jackson was brought after he stopped breathing. Mario Anzuoni/Reuters/Landov hide caption

    toggle caption Mario Anzuoni/Reuters/Landov

    Ronald Reagan UCLA Medical Center was fined $95,000 by the California Department of Public Health for failing to stop employees from accessing singer Michael Jackson’s records. Two hospital workers and two contract employees were terminated.

  • January 2011

    Gabrielle Giffords sits with her husband, Mark Kelly, at a Senate Judiciary Committee hearing on in 2013.

    Gabrielle Giffords sits with her husband, Mark Kelly, at a Senate Judiciary Committee hearing on in 2013. J. Scott Applewhite/AP hide caption

    toggle caption J. Scott Applewhite/AP

    University Medical Center in Tucson, Ariz., fired three employees for snooping in records after the shooting that left then-U.S. Rep. Gabrielle Giffords in critical condition. A contract nurse also was terminated.

  • July 2011

    UCLA Medical Center in Los Angeles has many celebrity patients.

    UCLA Medical Center in Los Angeles has many celebrity patients. Lucy Nicholson/Reuters/Landov hide caption

    toggle caption Lucy Nicholson/Reuters/Landov

    UCLA Health System agreed to pay $865,000 to the federal government to resolve allegations that its employees violated federal patient privacy laws by snooping in the medical records of two celebrity patients. Separately, in January 2010, a former UCLA employee pleaded guilty to four counts of illegally reading medical records, mostly from celebrities and other high-profile patients, and was sentenced to four months in federal prison.

  • July 2013

    Kim Kardashian, North West and Kanye West attend a fashion show in February.

    Kim Kardashian, North West and Kanye West attend a fashion show in February. Craig Barritt/Getty Images hide caption

    toggle caption Craig Barritt/Getty Images

    Five workers and a student research assistant were fired for inappropriately accessing records at Cedars-Sinai Medical Center in Los Angeles. One of those was reportedly reality TV star Kim Kardashian, who gave birth to her daughter at the hospital the prior month.

  • September 2014

    Ebola survivor Dr. Rick Sacra speaks to the media about his experience on Sept. 26, 2014, in Worcester, Mass.

    Ebola survivor Dr. Rick Sacra speaks to the media about his experience on Sept. 26, 2014, in Worcester, Mass. Stephan Saviola/AP hide caption

    toggle caption Stephan Saviola/AP

    Nebraska Medical Center in Omaha fired two workers for looking in the records of Dr. Rick Sacra, who had been treated at the hospital for the Ebola virus he contracted while volunteering in Africa.

ProPublica is a nonprofit newsroom based in New York. This story is part of a yearlong examination into the security of medical information. Has your medical privacy been compromised? Help ProPublica investigate by filling out a short questionnaire. You can also read other stories in the Policing Patient Privacy series.

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Small Violations Of Medical Privacy Can Hurt Patients And Corrode Trust

A chance referral led attorney Neal Eggeson into a practice focused on privacy breaches.

A chance referral led attorney Neal Eggeson into a practice focused on privacy breaches. AJ Mast for ProPublica hide caption

toggle caption AJ Mast for ProPublica

“PPL WORLD WIDE,” the Facebook post shouted, using text-speak for the word “people.” “FRANCES … IS HPV POSITIVE!”

The public missive from January 2014 gave Frances’ full name, along with the revelation that she had human papillomavirus, a sexually transmitted disease that can cause genital warts and cancer. It also included her date of birth and ended with a plea to friends: “PLZ HELP EXPOSE THIS HOE!”

Within hours, a friend told Frances that a former high school pal who lived near her in northwest Indiana had shared a secret that only her family and a former boyfriend knew, she later said.

“My heart fell to my stomach,” said Frances, a dental assistant in her late 20s who asked that her last name not be used. “I started crying immediately.”

The Facebook poster was a patient care technician at the local hospital where Frances was treated, but the two were no longer friends.

Frances complained to a nursing supervisor at the hospital, which sent her a letter of apology in March 2014.

Under the federal law called the Health Insurance Portability and Accountability Act, or HIPAA, it’s illegal for health care providers to share patients’ treatment information without their permission. The Office for Civil Rights, the arm of the Department of Health and Human Services responsible for enforcing the law, receives more than 30,000 reports about privacy violations each year.

The bulk of the government’s enforcement — and the public’s attention — has focused on a small number of splashy cases in which hackers or thieves have accessed the health data of large groups of people. But the damage done in these mass breaches has been mostly hypothetical, with much information exposed, but little exploited.

As Frances discovered, it’s often little-noticed smaller-scale violations of medical privacy – the ones that affect only one or two people – that inflict the most harm.

Driven by personal animus, jealousy or a desire for retribution, small breaches involving sensitive health details are spurring disputes and legal battles across the country:

In Tampa, Fla., a nurse snooped in the medical records of her nephew’s partner, learned that she had delivered a baby and had put the child up for adoption. She gave a printout to another family member, and the secret was announced at a family funeral in 2013, the Tampa Bay Times reported. The niece complained to the hospital; the nurse admitted what she did, was fired and relinquished her Florida nursing license.

And in New Jersey, a woman sued a local hospital this fall, alleging that one of its employees shared details about her 11-year-old son’s attempted suicide with people at his school. The boy was subsequently “bullied by his peers, called names and made fun of,” her lawsuit says.

Even when small privacy violations have real consequences, the federal Office for Civil Rights rarely punishes health care providers for them. Instead, the office typically settles for pledges to fix any problems and issues reminders of what the privacy law requires. It doesn’t even tell the public which health providers have reported small breaches — or how many.

Asked about some of the privacy violations highlighted in this report, OCR Director Jocelyn Samuels called them “heartbreaking stories” and “the kinds of harm that HIPAA is intended to address.”

She insisted her agency isn’t afraid to pursue formal sanctions when they are warranted, but said its primary role is helping health providers to follow the law. “Our preference is always to promote voluntary compliance,” Samuels said.

For patients, Samuels’ agency is usually the only place they can seek vindication. HIPAA does not give people the right to sue for damages if their privacy is violated. Patients who seek legal redress must find another cause of action, which is easier in some states than others.

After being attacked on Facebook, Frances contacted Indianapolis lawyer Neal Eggeson. He had won jury verdicts for people whose medical information was improperly disclosed. Eggeson contacted the hospital and, without filing suit, secured a confidential settlement for Frances. (He asked that the facility not be named in this story.) Frances’ former friend no longer works there, she said.

Frances said she still hasn’t fully recovered. She sees a therapist and has a hard time trusting others.

“It’s hard to even still deal with it,” she said. “I’ll spend that extra gas money to go into another city to do grocery shopping or stuff like that just so I don’t have to see anybody from around the neighborhood.”

Ties Of Friendship Lead Lawyer To Privacy Practice

Eggeson, a litigator, was defending insurance companies in car accident cases when a “friend of a friend of a friend” referred a young man to him. The man, who is HIV positive, had been sued over a $326 debt by the medical group that had been treating him. The group’s court filing gave the man’s name, home address, Social Security number and date of birth — and included a billing statement containing the phrase “Last Diagnosis: HIV.”

“His first concern was getting the court record sealed, more than anything else,” Eggeson said. “I don’t think he had any designs or visions beyond that.”

A jury awarded the man $1.25 million.

After that victory, Eggeson represented Abigail Hinchy, who alleged that a Walgreens pharmacist had snooped in her prescription records and shared the information with the father of Hinchy’s child (the man was dating and later married the pharmacist). Among the data shared: Hinchy had stopped taking birth control pills shortly before she became pregnant. A jury ordered Walgreens and the pharmacist to pay Hinchy $1.44 million.

A copy of Walgreens’ check is framed on the wall of Eggeson’s home office, not far from his life-sized Batman costume and Star Wars lightsabers.

Neal Eggeson works out of a tiny office in his suburban Indianapolis home.

Neal Eggeson works out of a tiny office in his suburban Indianapolis home. AJ Mast for ProPublica hide caption

toggle caption AJ Mast for ProPublica

Among Eggeson’s current clients is a couple who claim that when their son was in an ATV accident this August, a hospital worker posted a comment on Facebook before the hospital had told them the teen had died. Panicked relatives who saw the post began calling his parents for updates, adding stress to an already wrenching time.

“It wouldn’t have changed the outcome,” said John Stuck, the boy’s father, “but just the feeling of what in the heck, what do they know that we don’t, that’s what freaked me out I think the most.”

When Eggeson files lawsuits, he argues that privacy breaches amount to medical malpractice.

While Indiana courts have been receptive to such arguments, courts in Ohio, Minnesota and other states have ruled that health providers are not liable for the actions of workers who snoop in medical records outside the scope of their jobs.

This summer, a Los Angeles jury ruled against a patient who sued UCLA and the Regents of the University of California after a romantic rival accessed and shared her medical records. The rival was a temporary worker in the office of a private practice physician affiliated with UCLA’s Santa Monica hospital. The doctor acknowledged improperly sharing his password and settled his part of the lawsuit.

Eggeson said it’s distressing that more states aren’t like Indiana.

“Privacy protections should be the same regardless of what state you’re in,” he said. “There is something wrong with an employer providing the means, providing the access, and providing the tools by which an employee can commit this crime and then being able to hold up their hands and say, ‘It’s not our fault.'”

Federal Focus On Large Breaches Draws Criticism

The vast majority of the federal Office for Civil Rights’ enforcement work has been directed at large-scale medical data breaches, whether or not they result in any demonstrable real-world harm.

Health providers are required to notify the office within 60 days of breaches affecting at least 500 people and also must share details with the media and contact those potentially affected. OCR’s website makes public a list of these cases, highlighting them on what industry insiders dub the Wall of Shame.

Rarely do small privacy breaches get anywhere near the same attention, except when they involve celebrities or high-profile individuals.

Organizations only have to report them to OCR once a year. Even then, the agency doesn’t post them online. HHS has rejected requests under the Freedom of Information Act for information about them.

Since 2009, OCR has received information about 1,400 large breaches. During the same time, more than 181,000 breaches affecting fewer than 500 individuals have been reported.

In September, the HHS inspector general issued a pair of reports that criticized the Office for Civil Rights, including its handling of small breaches. The inspector general said OCR did not investigate the small breaches reported to it or log them in its tracking system.

“OCR does not record that information and therefore it’s not available for staff to be able to look over time” for repeat offenders, said Blaine Collins, regional inspector general for evaluation and inspections in San Francisco. “Boy, that’s critical for monitoring and oversight.”

Samuels said that her agency is implementing the inspector general’s recommendations to improve oversight. “We are constantly looking for ways to better serve the public and improve our operations,” she said.

Pain Doctor Gives Private Investigator Patient’s Records

Peter Brabeck, a 73-year-old retired petrophysicist who had worked for the oil giant BP, turned to OCR in September 2011 when he found himself in the midst of a nightmare.

It began a year earlier when Brabeck’s brother complained to the Medical Board of California that Dr. Steven Mangar, a pain doctor in Salinas, Calif., had overprescribed controlled substances to Peter. The medical board accused Mangar of prescribing drugs without examining him and sought to take disciplinary action against Mangar’s license.

The Medical Board of California accused Peter Brabeck's doctor in 2011 of overprescribing him controlled substances. Afterward, Brabeck, who lives near Carmel, Calif., learned the doctor had hired a private investigator and gave him Brabeck's medical records.

The Medical Board of California accused Peter Brabeck’s doctor in 2011 of overprescribing him controlled substances. Afterward, Brabeck, who lives near Carmel, Calif., learned the doctor had hired a private investigator and gave him Brabeck’s medical records. Ramin Rahimian for ProPublica hide caption

toggle caption Ramin Rahimian for ProPublica

Mangar reacted by hiring a private investigator to dig up dirt on Brabeck — and gave the investigator all of Brabeck’s medical records. When Mangar refused to pay the investigator, he approached Brabeck’s brother and showed him the records. The investigator then offered to sell the records to Peter Brabeck, who within days complained to the Office for Civil Rights.

“Here we have not only a gross violation of [HIPAA] laws protecting the confidentiality of every patient’s medical history, but in my mind far worse,” Brabeck wrote in his complaint. “Here is a deliberate attempt, born of vengeance, with malice aforethought to inflict great harm on his own patient.”

Two years later, the Office for Civil Rights wrote back, saying it was “pleased to inform” Brabeck that his complaint has been resolved. It said it had provided Mangar’s clinic, the Pacific Pain Care Institute, with guidance on how to comply with privacy rules. It said Mangar had acknowledged that he “impermissibly disclosed” Brabeck’s personal health information to the private investigator.

OCR also said that Mangar had agreed to provide Brabeck with free credit monitoring.

Brabeck, who lives near Carmel, Calif., said he never actually received the credit monitoring. More importantly, he was left with a sense that the agency didn’t take his case seriously.

“I made very clear in my letter that I was an act of vengeance and retaliation,” he said. “That’s why I was so surprised at how lightly they dismissed the whole thing.”

Mangar did not return calls for comment. California’s medical board placed his license on probation in 2012 and is now seeking to revoke it, saying he violated his probation and provided negligent care to other patients. Earlier this year, federal and state investigators served search warrants at Mangar’s office and home. Monterey County Deputy District Attorney Amy Patterson said Brabeck’s concerns are part of a much broader investigation that she could not discuss because it is ongoing.

OCR director Samuels said Brabeck’s case predated her arrival at the agency. But she said it was consistent with “our general principles” in terms of the nature of the injury, the number of individuals affected and a provider’s lack of prior HIPAA violations. She also said the doctor agreed to apologize, which “can be very powerful in terms of remedying the damage that has been done.”

Brabeck said he didn’t get an apology: “No. Absolutely not.”

NPR correspondent Alison Kodjak contributed to this report.

ProPublica is a nonprofit newsroom based in New York. This story is part of a yearlong examination into the security of medical information. Has your medical privacy been compromised? Help ProPublica investigate by filling out a short questionnaire. You can also read other stories in the Policing Patient Privacy series.


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