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Your Medical Devices Are Not Keeping Your Health Data to Themselves

[Editor's note: today's guest post, by reporters at ProPublica, is part of a series which explores data collection, data sharing, and privacy issues within the healthcare industry. It is reprinted with permission.]

By Derek Kravitz and Marshall Allen, ProPublica

Medical devices are gathering more and more data from their users, whether it’s their heart rates, sleep patterns or the number of steps taken in a day. Insurers and medical device makers say such data can be used to vastly improve health care.

But the data that’s generated can also be used in ways that patients don’t necessarily expect. It can be packaged and sold for advertising. It can anonymized and used by customer support and information technology companies. Or it can be shared with health insurers, who may use it to deny reimbursement. Privacy experts warn that data gathered by insurers could also be used to rate individuals’ health care costs and potentially raise their premiums.

Patients typically have to give consent for their data to be used — so-called “donated data.” But some patients said they weren’t aware that their information was being gathered and shared. And once the data is shared, it can be used in a number of ways. Here are a few of the most popular medical devices that can share data with insurers:

Continuous Positive Airway Pressure, or CPAP, Machines

What Are They?

One of the more popular devices for those with sleep apnea, CPAP machines are covered by insurers after a sleep study confirms the diagnosis. These units, which deliver pressurized air through masks worn by patients as they sleep, collect data and transmit it wirelessly.

What Do They Collect?

It depends on the unit, but CPAP machines can collect data on the number of hours a patient uses the device, the number of interruptions in sleep and the amount of air that leaks from the mask.

Who Gets the Info?

The data may be transmitted to the makers or suppliers of the machines. Doctors may use it to assess whether the therapy is effective. Health insurers may receive the data to track whether patients are using their CPAP machines as directed. They may refuse to reimburse the costs of the machine if the patient doesn’t use it enough. The device maker ResMed said in a statement that patients may withdraw their consent to have their data shared.

Heart Monitors

What Are They?

Heart monitors, oftentimes small, battery-powered devices worn on the body and attached to the skin with electrodes, measure and record the heart’s electrical signals, typically over a few days or weeks, to detect things like irregular heartbeats or abnormal heart rhythms. Some devices implanted under the skin can last up to five years.

What Do They Collect?

Wearable ones include Holter monitors, wired external devices that attach to the skin, and event recorders, which can track slow or fast heartbeats and fainting spells. Data can also be shared from implanted pacemakers, which keep the heart beating properly for those with arrhythmias.

Who Gets the Info?

Low resting heart rates or other abnormal heart conditions are commonly used by insurance companies to place patients in more expensive rate classes. Children undergoing genetic testing are sometimes outfitted with heart monitors before their diagnosis, increasing the odds that their data is used by insurers. This sharing is the most common complaint cited by the World Privacy Forum, a consumer rights group.

Blood Glucose Monitors

What Are They?

Millions of Americans who have diabetes are familiar with blood glucose meters, or glucometers, which take a blood sample on a strip of paper and analyze it for glucose, or sugar, levels. This allows patients and their doctors to monitor their diabetes so they don’t have complications like heart or kidney disease. Blood glucose meters are used by the more the 1.2 million Americans with Type 1 diabetes, which is usually diagnosed in children, teens and young adults.

What Do They Collect?

Blood sugar monitors measure the concentration of glucose in a patient’s blood, a key indicator of proper diabetes management.

Who Gets the Info?

Diabetes monitoring equipment is sold directly to patients, but many still rely on insurer-provided devices. To get reimbursement for blood glucose meters, health insurers will typically ask for at least a month’s worth of blood sugar data.

Lifestyle Monitors

What Are They?

Step counters, medication alerts and trackers, and in-home cameras are among the devices in the increasingly crowded lifestyle health industry.

What Do They Collect?

Many health data research apps are made up of “donated data,” which is provided by consumers and falls outside of federal guidelines that require the sharing of personal health data be disclosed and anonymized to protect the identity of the patient. This data includes everything from counters for the number of steps you take, the calories you eat and the number of flights of stairs you climb to more traditional health metrics, such as pulse and heart rates.

Who Gets the Info?

It varies by device. But the makers of the Fitbit step counter, for example, say they never sell customer personal data or share personal information unless a user requests it; it is part of a legal process; or it is provided on a “confidential basis” to a third-party customer support or IT provider. That said, Fitbit allows users who give consent to share data “with a health insurer or wellness program,” according to a statement from the company.

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You Snooze, You Lose: Insurers Make The Old Adage Literally True

[Editor's note: today's guest post, by reporters at ProPublica, is part of a series which explores data collection, data sharing, and privacy issues within the healthcare industry. It is reprinted with permission.]

By Marshall Allen, ProPublica

Last March, Tony Schmidt discovered something unsettling about the machine that helps him breathe at night. Without his knowledge, it was spying on him.

From his bedside, the device was tracking when he was using it and sending the information not just to his doctor, but to the maker of the machine, to the medical supply company that provided it and to his health insurer.

Schmidt, an information technology specialist from Carrollton, Texas, was shocked. “I had no idea they were sending my information across the wire.”

Schmidt, 59, has sleep apnea, a disorder that causes worrisome breaks in his breathing at night. Like millions of people, he relies on a continuous positive airway pressure, or CPAP, machine that streams warm air into his nose while he sleeps, keeping his airway open. Without it, Schmidt would wake up hundreds of times a night; then, during the day, he’d nod off at work, sometimes while driving and even as he sat on the toilet.

“I couldn’t keep a job,” he said. “I couldn’t stay awake.” The CPAP, he said, saved his career, maybe even his life.

As many CPAP users discover, the life-altering device comes with caveats: Health insurance companies are often tracking whether patients use them. If they aren’t, the insurers might not cover the machines or the supplies that go with them.

In fact, faced with the popularity of CPAPs, which can cost $400 to $800, and their need for replacement filters, face masks and hoses, health insurers have deployed a host of tactics that can make the therapy more expensive or even price it out of reach.

Patients have been required to rent CPAPs at rates that total much more than the retail price of the devices, or they’ve discovered that the supplies would be substantially cheaper if they didn’t have insurance at all.

Experts who study health care costs say insurers’ CPAP strategies are part of the industry’s playbook of shifting the costs of widely used therapies, devices and tests to unsuspecting patients.

“The doctors and providers are not in control of medicine anymore,” said Harry Lawrence, owner of Advanced Oxy-Med Services, a New York company that provides CPAP supplies. “It’s strictly the insurance companies. They call the shots.”

Insurers say their concerns are legitimate. The masks and hoses can be cumbersome and noisy, and studies show that about third of patients don’t use their CPAPs as directed.

But the companies’ practices have spawned lawsuits and concerns by some doctors who say that policies that restrict access to the machines could have serious, or even deadly, consequences for patients with severe conditions. And privacy experts worry that data collected by insurers could be used to discriminate against patients or raise their costs.

Schmidt’s privacy concerns began the day after he registered his new CPAP unit with ResMed, its manufacturer. He opted out of receiving any further information. But he had barely wiped the sleep out of his eyes the next morning when a peppy email arrived in his inbox. It was ResMed, praising him for completing his first night of therapy. “Congratulations! You’ve earned yourself a badge!” the email said.

Then came this exchange with his supply company, Medigy: Schmidt had emailed the company to praise the “professional, kind, efficient and competent” technician who set up the device. A Medigy representative wrote back, thanking him, then adding that Schmidt’s machine “is doing a great job keeping your airway open.” A report detailing Schmidt’s usage was attached.

Alarmed, Schmidt complained to Medigy and learned his data was also being shared with his insurer, Blue Cross Blue Shield. He’d known his old machine had tracked his sleep because he’d taken its removable data card to his doctor. But this new invasion of privacy felt different. Was the data encrypted to protect his privacy as it was transmitted? What else were they doing with his personal information?

He filed complaints with the Better Business Bureau and the federal government to no avail. “My doctor is the ONLY one that has permission to have my data,” he wrote in one complaint.

In an email, a Blue Cross Blue Shield spokesperson said that it’s standard practice for insurers to monitor sleep apnea patients and deny payment if they aren’t using the machine. And privacy experts said that sharing the data with insurance companies is allowed under federal privacy laws. A ResMed representative said once patients have given consent, it may share the data it gathers, which is encrypted, with the patients’ doctors, insurers and supply companies.

Schmidt returned the new CPAP machine and went back to a model that allowed him to use a removable data card. His doctor can verify his compliance, he said.

Luke Petty, the operations manager for Medigy, said a lot of CPAP users direct their ire at companies like his. The complaints online number in the thousands. But insurance companies set the prices and make the rules, he said, and suppliers follow them, so they can get paid.

“Every year it’s a new hurdle, a new trick, a new game for the patients,” Petty said.

A Sleep Saving Machine Gets Popular

The American Sleep Apnea Association estimates about 22 million Americans have sleep apnea, although it’s often not diagnosed. The number of people seeking treatment has grown along with awareness of the disorder. It’s a potentially serious disorder that left untreated can lead to risks for heart disease, diabetes, cancer and cognitive disorders. CPAP is one of the only treatments that works for many patients.

Exact numbers are hard to come by, but ResMed, the leading device maker, said it’s monitoring the CPAP use of millions of patients.

Sleep apnea specialists and health care cost experts say insurers have countered the deluge by forcing patients to prove they’re using the treatment.

Medicare, the government insurance program for seniors and the disabled, began requiring CPAP “compliance” after a boom in demand. Because of the discomfort of wearing a mask, hooked up to a noisy machine, many patients struggle to adapt to nightly use. Between 2001 and 2009, Medicare payments for individual sleep studies almost quadrupled to $235 million. Many of those studies led to a CPAP prescription. Under Medicare rules, patients must use the CPAP for four hours a night for at least 70 percent of the nights in any 30-day period within three months of getting the device. Medicare requires doctors to document the adherence and effectiveness of the therapy.

Sleep apnea experts deemed Medicare’s requirements arbitrary. But private insurers soon adopted similar rules, verifying usage with data from patients’ machines — with or without their knowledge.

Kristine Grow, spokeswoman for the trade association America’s Health Insurance Plans, said monitoring CPAP use is important because if patients aren’t using the machines, a less expensive therapy might be a smarter option. Monitoring patients also helps insurance companies advise doctors about the best treatment for patients, she said. When asked why insurers don’t just rely on doctors to verify compliance, Grow said she didn’t know.

Many insurers also require patients to rack up monthly rental fees rather than simply pay for a CPAP.

Dr. Ofer Jacobowitz, a sleep apnea expert at ENT and Allergy Associates and assistant professor at The Mount Sinai Hospital in New York, said his patients often pay rental fees for a year or longer before meeting the prices insurers set for their CPAPs. But since patients’ deductibles — the amount they must pay before insurance kicks in — reset at the beginning of each year, they may end up covering the entire cost of the rental for much of that time, he said.

The rental fees can surpass the retail cost of the machine, patients and doctors say. Alan Levy, an attorney who lives in Rahway, New Jersey, bought an individual insurance plan through the now-defunct Health Republic Insurance of New Jersey in 2015. When his doctor prescribed a CPAP, the company that supplied his device, At Home Medical, told him he needed to rent the device for $104 a month for 15 months. The company told him the cost of the CPAP was $2,400.

Levy said he wouldn’t have worried about the cost if his insurance had paid it. But Levy’s plan required him to reach a $5,000 deductible before his insurance plan paid a dime. So Levy looked online and discovered the machine actually cost about $500.

Levy said he called At Home Medical to ask if he could avoid the rental fee and pay $500 up front for the machine, and a company representative said no. “I’m being overcharged simply because I have insurance,” Levy recalled protesting.

Levy refused to pay the rental fees. “At no point did I ever agree to enter into a monthly rental subscription,” he wrote in a letter disputing the charges. He asked for documentation supporting the cost. The company responded that he was being billed under the provisions of his insurance carrier.

Levy’s law practice focuses, ironically, on defending insurance companies in personal injury cases. So he sued At Home Medical, accusing the company of violating the New Jersey Consumer Fraud Act. Levy didn’t expect the case to go to trial. “I knew they were going to have to spend thousands of dollars on attorney’s fees to defend a claim worth hundreds of dollars,” he said.

Sure enough, At Home Medical, agreed to allow Levy to pay $600 — still more than the retail cost — for the machine.

The company declined to comment on the case. Suppliers said that Levy’s case is extreme, but acknowledged that patients’ rental fees often add up to more than the device is worth.

Levy said that he was happy to abide by the terms of his plan, but that didn’t mean the insurance company could charge him an unfair price. “If the machine’s worth $500, no matter what the plan says, or the medical device company says, they shouldn’t be charging many times that price,” he said.

Dr. Douglas Kirsch, president of the American Academy of Sleep Medicine, said high rental fees aren’t the only problem. Patients can also get better deals on CPAP filters, hoses, masks and other supplies when they don’t use insurance, he said.

Cigna, one of the largest health insurers in the country, currently faces a class-action suit in U.S. District Court in Connecticut over its billing practices, including for CPAP supplies. One of the plaintiffs, Jeffrey Neufeld, who lives in Connecticut, contends that Cigna directed him to order his supplies through a middleman who jacked up the prices.

Neufeld declined to comment for this story. But his attorney, Robert Izard, said Cigna contracted with a company called CareCentrix, which coordinates a network of suppliers for the insurer. Neufeld decided to contact his supplier directly to find out what it had been paid for his supplies and compare that to what he was being charged. He discovered that he was paying substantially more than the supplier said the products were worth. For instance, Neufeld owed $25.68 for a disposable filter under his Cigna plan, while the supplier was paid $7.50. He owed $147.78 for a face mask through his Cigna plan while the supplier was paid $95.

ProPublica found all the CPAP supplies billed to Neufeld online at even lower prices than those the supplier had been paid. Longtime CPAP users say it’s well known that supplies are cheaper when they are purchased without insurance.

Neufeld’s cost “should have been based on the lower amount charged by the actual provider, not the marked-up bill from the middleman,” Izard said. Patients covered by other insurance companies may have fallen victim to similar markups, he said.

Cigna would not comment on the case. But in documents filed in the suit, it denied misrepresenting costs or overcharging Neufeld. The supply company did not return calls for comment.

In a statement, Stephen Wogen, CareCentrix’s chief growth officer, said insurers may agree to pay higher prices for some services, while negotiating lower prices for others, to achieve better overall value. For this reason, he said, isolating select prices doesn’t reflect the overall value of the company’s services. CareCentrix declined to comment on Neufeld’s allegations.

Izard said Cigna and CareCentrix benefit from such behind-the-scenes deals by shifting the extra costs to patients, who often end up covering the marked-up prices out of their deductibles. And even once their insurance kicks in, the amount the patients must pay will be much higher.

The ubiquity of CPAP insurance concerns struck home during the reporting of this story, when a ProPublica colleague discovered how his insurer was using his data against him.

Sleep Aid or Surveillance Device?

Without his CPAP, Eric Umansky, a deputy managing editor at ProPublica, wakes up repeatedly through the night and snores so insufferably that he is banished to the living room couch. “My marriage depends on it.”

In September, his doctor prescribed a new mask and airflow setting for his machine. Advanced Oxy-Med Services, the medical supply company approved by his insurer, sent him a modem that he plugged into his machine, giving the company the ability to change the settings remotely if needed.

But when the mask hadn’t arrived a few days later, Umansky called Advanced Oxy-Med. That’s when he got a surprise: His insurance company might not pay for the mask, a customer service representative told him, because he hadn’t been using his machine enough. “On Tuesday night, you only used the mask for three-and-a-half hours,” the representative said. “And on Monday night, you only used it for three hours.”

“Wait — you guys are using this thing to track my sleep?” Umansky recalled saying. “And you are using it to deny me something my doctor says I need?”

Umansky’s new modem had been beaming his personal data from his Brooklyn bedroom to the Newburgh, New York-based supply company, which, in turn, forwarded the information to his insurance company, UnitedHealthcare.

Umansky was bewildered. He hadn’t been using the machine all night because he needed a new mask. But his insurance company wouldn’t pay for the new mask until he proved he was using the machine all night — even though, in his case, he, not the insurance company, is the owner of the device.

“You view it as a device that is yours and is serving you,” Umansky said. “And suddenly you realize it is a surveillance device being used by your health insurance company to limit your access to health care.”

Privacy experts said such concerns are likely to grow as a host of devices now gather data about patients, including insertable heart monitors and blood glucose meters, as well as Fitbits, Apple Watches and other lifestyle applications. Privacy laws have lagged behind this new technology, and patients may be surprised to learn how little control they have over how the data is used or with whom it is shared, said Pam Dixon, executive director of the World Privacy Forum.

“What if they find you only sleep a fitful five hours a night?” Dixon said. “That’s a big deal over time. Does that affect your health care prices?”

UnitedHealthcare said in a statement that it only uses the data from CPAPs to verify patients are using the machines.

Lawrence, the owner of Advanced Oxy-Med Services, conceded that his company should have told Umansky his CPAP use would be monitored for compliance, but it had to follow the insurers’ rules to get paid.

As for Umansky, it’s now been two months since his doctor prescribed him a new airflow setting for his CPAP machine. The supply company has been paying close attention to his usage, Umansky said, but it still hasn’t updated the setting.

The irony is not lost on Umansky: “I wish they would spend as much time providing me actual care as they do monitoring whether I’m ‘compliant.’”

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Data Breach Affects 75,000 Healthcare.gov Users

On Friday, the Centers For Medicare and Medicaid Services (CMS) announced a data breach at a computer system which interacts with the Healthcare.gov site. Files for about 75,000 users -- agents and brokers -- were accessed by unauthorized persons. The announcement stated:

"Earlier this week, CMS staff detected anomalous activity in the Federally Facilitated Exchanges, or FFE’s Direct Enrollment pathway for agents and brokers. The Direct Enrollment pathway, first launched in 2013, allows agents and brokers to assist consumers with applications for coverage in the FFE... CMS began the initial investigation of anomalous system activity in the Direct Enrollment pathway for agents and brokers on October 13, 2018 and a breach was declared on October 16, 2018. The agent and broker accounts that were associated with the anomalous activity were deactivated, and – out of an abundance of caution – the Direct Enrollment pathway for agents and brokers was disabled."

CMS has notified and is working with Federal law enforcement. It expects to restore the Direct Enrollment pathway for agents and brokers within the next 7 days, before the start of the sign-up period on November 1st for health care coverage under the Affordable Care Act.

CMS Administrator Seema Verma said:

"I want to make clear to the public that HealthCare.gov and the Marketplace Call Center are still available, and open enrollment will not be negatively impacted. We are working to identify the individuals potentially impacted as quickly as possible so that we can notify them and provide resources such as credit protection."

Sadly, data breaches happen -- all too often within government agencies and corporations. It should be noted that this breach was detected quickly -- within 3 days. Other data breaches have gone undetected for weeks or months; and too many corporate data breaches affected millions.

 


Aetna To Pay More Than $17 Million To Resolve 2 Privacy Breaches

Aetna logo Aetna inked settlement agreements with several states, including New Jersey, to resolve disclosures of sensitive patient information. According to an announcement by the Attorney General for New Jersey, the settlement agreements resolve:

"... a multi-state investigation focused on two separate privacy breaches by Aetna that occurred in 2017 – one involving a mailing that potentially revealed information about addressees’ HIV/AIDS status, the other involving a mailing that potentially revealed individuals’ involvement in a study of patients with atrial fibrillation (or AFib)..."

Connecticut, Washington, and the District of Columbia joined with New Jersey for both the  investigation and settlement agreements. The multi-state investigation found:

"... that Aetna inadvertently disclosed HIV/AIDS-related information about thousands of individuals across the U.S. – including approximately 647 New Jersey residents – through a third-party mailing on July 28, 2017. The envelopes used in the mailing had an over-sized, transparent glassine address window, which revealed not only the recipients’ names and addresses, but also text that included the words “HIV Medications"... The second breach occurred in September 2017 and involved a mailing sent to 1,600 individuals concerning a study of patients with AFib. The envelopes for the mailing included the name and logo for the study – IMPACT AFib – which could have been interpreted as indicating that the addressee had an AFib diagnosis... Aetna not only violated the federal Health Insurance Portability and Accountability Act (HIPAA), but also state laws pertaining to the protected health information of individuals in general, and of persons with AIDS or HIV infection in particular..."

A class-action lawsuit filed on behalf of affected HIV/AIDS patients has been settled, pending approval from a federal court, which requires Aetna to pay about $17 million to resolve allegations. Terms of the multi-state settlement agreement require Aetna to pay a $365,211.59 civil penalty to New Jersey, and:

  • Implement policy, processes, and employee training reforms to both better protect persons' protected health information, and ensure mailings maintain persons' privacy; and
  • Hire an independent consultant to evaluate and report on its privacy protection practices, and to monitor its compliance with the terms of the settlement agreements.

CVS Health logo In December of last year, CVS Health and Aetna announced a merger agreement where CVS Health acquired Aetna for about $69 billion. Last week, CVS Health announced an expansion of its board of directors to include the addition of three directors from its Aetna unit. At press time, neither company's website mentioned the multi-state settlement agreement.


Health Insurers Are Vacuuming Up Details About You — And It Could Raise Your Rates

[Editor's note: today's guest post, by reporters at ProPublica, explores privacy and data collection issues within the healthcare industry. It is reprinted with permission.]

By Marshall Allen, ProPublica

To an outsider, the fancy booths at last month’s health insurance industry gathering in San Diego aren’t very compelling. A handful of companies pitching “lifestyle” data and salespeople touting jargony phrases like “social determinants of health.”

But dig deeper and the implications of what they’re selling might give many patients pause: A future in which everything you do — the things you buy, the food you eat, the time you spend watching TV — may help determine how much you pay for health insurance.

With little public scrutiny, the health insurance industry has joined forces with data brokers to vacuum up personal details about hundreds of millions of Americans, including, odds are, many readers of this story. The companies are tracking your race, education level, TV habits, marital status, net worth. They’re collecting what you post on social media, whether you’re behind on your bills, what you order online. Then they feed this information into complicated computer algorithms that spit out predictions about how much your health care could cost them.

Are you a woman who recently changed your name? You could be newly married and have a pricey pregnancy pending. Or maybe you’re stressed and anxious from a recent divorce. That, too, the computer models predict, may run up your medical bills.

Are you a woman who’s purchased plus-size clothing? You’re considered at risk of depression. Mental health care can be expensive.

Low-income and a minority? That means, the data brokers say, you are more likely to live in a dilapidated and dangerous neighborhood, increasing your health risks.

“We sit on oceans of data,” said Eric McCulley, director of strategic solutions for LexisNexis Risk Solutions, during a conversation at the data firm’s booth. And he isn’t apologetic about using it. “The fact is, our data is in the public domain,” he said. “We didn’t put it out there.”

Insurers contend they use the information to spot health issues in their clients — and flag them so they get services they need. And companies like LexisNexis say the data shouldn’t be used to set prices. But as a research scientist from one company told me: “I can’t say it hasn’t happened.”

At a time when every week brings a new privacy scandal and worries abound about the misuse of personal information, patient advocates and privacy scholars say the insurance industry’s data gathering runs counter to its touted, and federally required, allegiance to patients’ medical privacy. The Health Insurance Portability and Accountability Act, or HIPAA, only protects medical information.

“We have a health privacy machine that’s in crisis,” said Frank Pasquale, a professor at the University of Maryland Carey School of Law who specializes in issues related to machine learning and algorithms. “We have a law that only covers one source of health information. They are rapidly developing another source.”

Patient advocates warn that using unverified, error-prone “lifestyle” data to make medical assumptions could lead insurers to improperly price plans — for instance raising rates based on false information — or discriminate against anyone tagged as high cost. And, they say, the use of the data raises thorny questions that should be debated publicly, such as: Should a person’s rates be raised because algorithms say they are more likely to run up medical bills? Such questions would be moot in Europe, where a strict law took effect in May that bans trading in personal data.

This year, ProPublica and NPR are investigating the various tactics the health insurance industry uses to maximize its profits. Understanding these strategies is important because patients — through taxes, cash payments and insurance premiums — are the ones funding the entire health care system. Yet the industry’s bewildering web of strategies and inside deals often have little to do with patients’ needs. As the series’ first story showed, contrary to popular belief, lower bills aren’t health insurers’ top priority.

Inside the San Diego Convention Center last month, there were few qualms about the way insurance companies were mining Americans’ lives for information — or what they planned to do with the data.

The sprawling convention center was a balmy draw for one of America’s Health Insurance Plans’ marquee gatherings. Insurance executives and managers wandered through the exhibit hall, sampling chocolate-covered strawberries, champagne and other delectables designed to encourage deal-making.

Up front, the prime real estate belonged to the big guns in health data: The booths of Optum, IBM Watson Health and LexisNexis stretched toward the ceiling, with flat screen monitors and some comfy seating. (NPR collaborates with IBM Watson Health on national polls about consumer health topics.)

To understand the scope of what they were offering, consider Optum. The company, owned by the massive UnitedHealth Group, has collected the medical diagnoses, tests, prescriptions, costs and socioeconomic data of 150 million Americans going back to 1993, according to its marketing materials. (UnitedHealth Group provides financial support to NPR.) The company says it uses the information to link patients’ medical outcomes and costs to details like their level of education, net worth, family structure and race. An Optum spokesman said the socioeconomic data is de-identified and is not used for pricing health plans.

Optum’s marketing materials also boast that it now has access to even more. In 2016, the company filed a patent application to gather what people share on platforms like Facebook and Twitter, and link this material to the person’s clinical and payment information. A company spokesman said in an email that the patent application never went anywhere. But the company’s current marketing materials say it combines claims and clinical information with social media interactions.

I had a lot of questions about this and first reached out to Optum in May, but the company didn’t connect me with any of its experts as promised. At the conference, Optum salespeople said they weren’t allowed to talk to me about how the company uses this information.

It isn’t hard to understand the appeal of all this data to insurers. Merging information from data brokers with people’s clinical and payment records is a no-brainer if you overlook potential patient concerns. Electronic medical records now make it easy for insurers to analyze massive amounts of information and combine it with the personal details scooped up by data brokers.

It also makes sense given the shifts in how providers are getting paid. Doctors and hospitals have typically been paid based on the quantity of care they provide. But the industry is moving toward paying them in lump sums for caring for a patient, or for an event, like a knee surgery. In those cases, the medical providers can profit more when patients stay healthy. More money at stake means more interest in the social factors that might affect a patient’s health.

Some insurance companies are already using socioeconomic data to help patients get appropriate care, such as programs to help patients with chronic diseases stay healthy. Studies show social and economic aspects of people’s lives play an important role in their health. Knowing these personal details can help them identify those who may need help paying for medication or help getting to the doctor.

But patient advocates are skeptical health insurers have altruistic designs on people’s personal information.

The industry has a history of boosting profits by signing up healthy people and finding ways to avoid sick people — called “cherry-picking” and “lemon-dropping,” experts say. Among the classic examples: A company was accused of putting its enrollment office on the third floor of a building without an elevator, so only healthy patients could make the trek to sign up. Another tried to appeal to spry seniors by holding square dances.

The Affordable Care Act prohibits insurers from denying people coverage based on pre-existing health conditions or charging sick people more for individual or small group plans. But experts said patients’ personal information could still be used for marketing, and to assess risks and determine the prices of certain plans. And the Trump administration is promoting short-term health plans, which do allow insurers to deny coverage to sick patients.

Robert Greenwald, faculty director of Harvard Law School’s Center for Health Law and Policy Innovation, said insurance companies still cherry-pick, but now they’re subtler. The center analyzes health insurance plans to see if they discriminate. He said insurers will do things like failing to include enough information about which drugs a plan covers — which pushes sick people who need specific medications elsewhere. Or they may change the things a plan covers, or how much a patient has to pay for a type of care, after a patient has enrolled. Or, Greenwald added, they might exclude or limit certain types of providers from their networks — like those who have skill caring for patients with HIV or hepatitis C.

If there were concerns that personal data might be used to cherry-pick or lemon-drop, they weren’t raised at the conference.

At the IBM Watson Health booth, Kevin Ruane, a senior consulting scientist, told me that the company surveys 80,000 Americans a year to assess lifestyle, attitudes and behaviors that could relate to health care. Participants are asked whether they trust their doctor, have financial problems, go online, or own a Fitbit and similar questions. The responses of hundreds of adjacent households are analyzed together to identify social and economic factors for an area.

Ruane said he has used IBM Watson Health’s socioeconomic analysis to help insurance companies assess a potential market. The ACA increased the value of such assessments, experts say, because companies often don’t know the medical history of people seeking coverage. A region with too many sick people, or with patients who don’t take care of themselves, might not be worth the risk.

Ruane acknowledged that the information his company gathers may not be accurate for every person. “We talk to our clients and tell them to be careful about this,” he said. “Use it as a data insight. But it’s not necessarily a fact.”

In a separate conversation, a salesman from a different company joked about the potential for error. “God forbid you live on the wrong street these days,” he said. “You’re going to get lumped in with a lot of bad things.”

The LexisNexis booth was emblazoned with the slogan “Data. Insight. Action.” The company said it uses 442 non-medical personal attributes to predict a person’s medical costs. Its cache includes more than 78 billion records from more than 10,000 public and proprietary sources, including people’s cellphone numbers, criminal records, bankruptcies, property records, neighborhood safety and more. The information is used to predict patients’ health risks and costs in eight areas, including how often they are likely to visit emergency rooms, their total cost, their pharmacy costs, their motivation to stay healthy and their stress levels.

People who downsize their homes tend to have higher health care costs, the company says. As do those whose parents didn’t finish high school. Patients who own more valuable homes are less likely to land back in the hospital within 30 days of their discharge. The company says it has validated its scores against insurance claims and clinical data. But it won’t share its methods and hasn’t published the work in peer-reviewed journals.

McCulley, LexisNexis’ director of strategic solutions, said predictions made by the algorithms about patients are based on the combination of the personal attributes. He gave a hypothetical example: A high school dropout who had a recent income loss and doesn’t have a relative nearby might have higher than expected health costs.

But couldn’t that same type of person be healthy? I asked.

“Sure,” McCulley said, with no apparent dismay at the possibility that the predictions could be wrong.

McCulley and others at LexisNexis insist the scores are only used to help patients get the care they need and not to determine how much someone would pay for their health insurance. The company cited three different federal laws that restricted them and their clients from using the scores in that way. But privacy experts said none of the laws cited by the company bar the practice. The company backed off the assertions when I pointed that the laws did not seem to apply.

LexisNexis officials also said the company’s contracts expressly prohibit using the analysis to help price insurance plans. They would not provide a contract. But I knew that in at least one instance a company was already testing whether the scores could be used as a pricing tool.

Before the conference, I’d seen a press release announcing that the largest health actuarial firm in the world, Milliman, was now using the LexisNexis scores. I tracked down Marcos Dachary, who works in business development for Milliman. Actuaries calculate health care risks and help set the price of premiums for insurers. I asked Dachary if Milliman was using the LexisNexis scores to price health plans and he said: “There could be an opportunity.”

The scores could allow an insurance company to assess the risks posed by individual patients and make adjustments to protect themselves from losses, he said. For example, he said, the company could raise premiums, or revise contracts with providers.

It’s too early to tell whether the LexisNexis scores will actually be useful for pricing, he said. But he was excited about the possibilities. “One thing about social determinants data — it piques your mind,” he said.

Dachary acknowledged the scores could also be used to discriminate. Others, he said, have raised that concern. As much as there could be positive potential, he said, “there could also be negative potential.”

It’s that negative potential that still bothers data analyst Erin Kaufman, who left the health insurance industry in January. The 35-year-old from Atlanta had earned her doctorate in public health because she wanted to help people, but one day at Aetna, her boss told her to work with a new data set.

To her surprise, the company had obtained personal information from a data broker on millions of Americans. The data contained each person’s habits and hobbies, like whether they owned a gun, and if so, what type, she said. It included whether they had magazine subscriptions, liked to ride bikes or run marathons. It had hundreds of personal details about each person.

The Aetna data team merged the data with the information it had on patients it insured. The goal was to see how people’s personal interests and hobbies might relate to their health care costs. But Kaufman said it felt wrong: The information about the people who knitted or crocheted made her think of her grandmother. And the details about individuals who liked camping made her think of herself. What business did the insurance company have looking at this information? “It was a dataset that really dug into our clients’ lives,” she said. “No one gave anyone permission to do this.”

In a statement, Aetna said it uses consumer marketing information to supplement its claims and clinical information. The combined data helps predict the risk of repeat emergency room visits or hospital admissions. The information is used to reach out to members and help them and plays no role in pricing plans or underwriting, the statement said.

Kaufman said she had concerns about the accuracy of drawing inferences about an individual’s health from an analysis of a group of people with similar traits. Health scores generated from arrest records, home ownership and similar material may be wrong, she said.

Pam Dixon, executive director of the World Privacy Forum, a nonprofit that advocates for privacy in the digital age, shares Kaufman’s concerns. She points to a study by the analytics company SAS, which worked in 2012 with an unnamed major health insurance company to predict a person’s health care costs using 1,500 data elements, including the investments and types of cars people owned.

The SAS study said higher health care costs could be predicted by looking at things like ethnicity, watching TV and mail order purchases.

“I find that enormously offensive as a list,” Dixon said. “This is not health data. This is inferred data.”

Data scientist Cathy O’Neil said drawing conclusions about health risks on such data could lead to a bias against some poor people. It would be easy to infer they are prone to costly illnesses based on their backgrounds and living conditions, said O’Neil, author of the book “Weapons of Math Destruction,” which looked at how algorithms can increase inequality. That could lead to poor people being charged more, making it harder for them to get the care they need, she said. Employers, she said, could even decide not to hire people with data points that could indicate high medical costs in the future.

O’Neil said the companies should also measure how the scores might discriminate against the poor, sick or minorities.

American policymakers could do more to protect people’s information, experts said. In the United States, companies can harvest personal data unless a specific law bans it, although California just passed legislation that could create restrictions, said William McGeveran, a professor at the University of Minnesota Law School. Europe, in contrast, passed a strict law called the General Data Protection Regulation, which went into effect in May.

“In Europe, data protection is a constitutional right,” McGeveran said.

Pasquale, the University of Maryland law professor, said health scores should be treated like credit scores. Federal law gives people the right to know their credit scores and how they’re calculated. If people are going to be rated by whether they listen to sad songs on Spotify or look up information about AIDS online, they should know, Pasquale said. “The risk of improper use is extremely high. And data scores are not properly vetted and validated and available for scrutiny.”

As I reported this story I wondered how the data vendors might be using my personal information to score my potential health costs. So, I filled out a request on the LexisNexis website for the company to send me some of the personal information it has on me. A week later a somewhat creepy, 182-page walk down memory lane arrived in the mail. Federal law only requires the company to provide a subset of the information it collected about me. So that’s all I got.

LexisNexis had captured details about my life going back 25 years, many that I’d forgotten. It had my phone numbers going back decades and my home addresses going back to my childhood in Golden, Colorado. Each location had a field to show whether the address was “high risk.” Mine were all blank. The company also collects records of any liens and criminal activity, which, thankfully, I didn’t have.

My report was boring, which isn’t a surprise. I’ve lived a middle-class life and grown up in good neighborhoods. But it made me wonder: What if I had lived in “high risk” neighborhoods? Could that ever be used by insurers to jack up my rates — or to avoid me altogether?

I wanted to see more. If LexisNexis had health risk scores on me, I wanted to see how they were calculated and, more importantly, whether they were accurate. But the company told me that if it had calculated my scores it would have done so on behalf of their client, my insurance company. So, I couldn’t have them.

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The DIY Revolution: Consumers Alter Or Build Items Previously Not Possible. Is It A Good Thing?

Recent advances in technology allow consumers to alter, customize, or build locally items previously not possible. These items are often referred to as Do-It-Yourself (DIY) products. You've probably heard DIY used in home repair and renovation projects on television. DIY now happens in some unexpected areas. Today's blog post highlights two areas.

DIY Glucose Monitors

Earlier this year, CNet described the bag an eight-year-old patient carries with her everywhere daily:

"... It houses a Dexcom glucose monitor and a pack of glucose tablets, which work in conjunction with the sensor attached to her arm and the insulin pump plugged into her stomach. The final item in her bag was an iPhone 5S. It's unusual for such a young child to have a smartphone. But Ruby's iPhone, which connects via Bluetooth to her Dexcom monitor, allowing [her mother] to read it remotely, illustrates the way technology has transformed the management of diabetes from an entirely manual process -- pricking fingers to measure blood sugar, writing down numbers in a notebook, calculating insulin doses and injecting it -- to a semi-automatic one..."

Some people have access to these new technologies, but many don't. Others want more connectivity and better capabilities. So, some creative "hacking" has resulted:

"There are people who are unwilling to wait, and who embrace unorthodox methods. (You can find them on Twitter via the hashtag #WeAreNotWaiting.) The Nightscout Foundation, an online diabetes community, figured out a workaround for the Pebble Watch. Groups such as Nightscout, Tidepool and OpenAPS are developing open-source fixes for diabetes that give major medical tech companies a run for their money... One major gripe of many tech-enabled diabetes patients is that the two devices they wear at all times -- the monitor and the pump -- don't talk to each other... diabetes will never be a hands-off disease to manage, but an artificial pancreas is basically as close as it gets. The FDA approved the first artificial pancreas -- the Medtronic 670G -- in October 2017. But thanks to a little DIY spirit, people have had them for years."

CNet shared the experience of another tech-enabled patient:

"Take Dana Lewis, founder of the open-source artificial pancreas system, or OpenAPS. Lewis started hacking her glucose monitor to increase the volume of the alarm so that it would wake her in the night. From there, Lewis tinkered with her equipment until she created a closed-loop system, which she's refined over time in terms of both hardware and algorithms that enable faster distribution of insulin. It has massively reduced the "cognitive burden" on her everyday life... JDRF, one of the biggest global diabetes research charities, said in October that it was backing the open-source community by launching an initiative to encourage rival manufacturers like Dexcom and Medtronic to open their protocols and make their devices interoperable."

Convenience and affordability are huge drivers. As you might have guessed, there are risks:

"Hacking a glucose monitor is not without risk -- inaccurate readings, failed alarms or the wrong dose of insulin distributed by the pump could have fatal consequences... Lewis and the OpenAPS community encourage people to embrace the build-your-own-pancreas method rather than waiting for the tech to become available and affordable."

Are DIY glucose monitors a good thing? Some patients think so as a way to achieve convenient and affordable healthcare solutions. That might lead you to conclude anything DIY is an improvement. Right? Keep reading.

DIY Guns

Got a 3-D printer? If so, then you can print your own DIY gun. How did this happen? How did the USA get to here? Wired explained:

"Five years ago, 25-year-old radical libertarian Cody Wilson stood on a remote central Texas gun range and pulled the trigger on the world’s first fully 3-D-printed gun... he drove back to Austin and uploaded the blueprints for the pistol to his website, Defcad.com... In the days after that first test-firing, his gun was downloaded more than 100,000 times. Wilson made the decision to go all in on the project, dropping out of law school at the University of Texas, as if to confirm his belief that technology supersedes law..."

The law intervened. Wilson stopped, took down his site, and then pursued a legal remedy:

"Two months ago, the Department of Justice quietly offered Wilson a settlement to end a lawsuit he and a group of co-plaintiffs have pursued since 2015 against the United States government. Wilson and his team of lawyers focused their legal argument on a free speech claim: They pointed out that by forbidding Wilson from posting his 3-D-printable data, the State Department was not only violating his right to bear arms but his right to freely share information. By blurring the line between a gun and a digital file, Wilson had also successfully blurred the lines between the Second Amendment and the First."

So, now you... anybody with an internet connection and a 3-D printer (and a computer-controlled milling machine for some advanced parts)... can produce their own DIY gun. No registration required. No licenses nor permits. No training required. And, that's anyone anywhere in the world.

Oh, there's more:

"The Department of Justice's surprising settlement, confirmed in court documents earlier this month, essentially surrenders to that argument. It promises to change the export control rules surrounding any firearm below .50 caliber—with a few exceptions like fully automatic weapons and rare gun designs that use caseless ammunition—and move their regulation to the Commerce Department, which won't try to police technical data about the guns posted on the public internet. In the meantime, it gives Wilson a unique license to publish data about those weapons anywhere he chooses."

As you might have guessed, Wilson is re-launching his website, but this time with blueprints for more DIY weaponry besides pistols: AR-15 rifles and semi-automatic weaponry. So, it will be easier for people to skirt federal and state gun laws. Is that a good thing?

You probably have some thoughts and concerns. I do. There are plenty of issues and questions. Are DIY products a good thing? Who is liable? How should laws be upgraded? How can society facilitate one set of DIY products and not the other? What related issues do you see? Any other notable DIY products?


New Jersey to Suspend Prominent Psychologist for Failing to Protect Patient Privacy

[Editor's note: today's guest blog post, by reporters at ProPublica, explores privacy issues within the healthcare industry. The post is reprinted with permission.]

By Charles Ornstein, ProPublica

A prominent New Jersey psychologist is facing the suspension of his license after state officials concluded that he failed to keep details of mental health diagnoses and treatments confidential when he sued his patients over unpaid bills.

The state Board of Psychological Examiners last month upheld a decision by an administrative law judge that the psychologist, Barry Helfmann, “did not take reasonable measures to protect the confidentiality of his patients’ protected health information,” Lisa Coryell, a spokeswoman for the state attorney general’s office, said in an e-mail.

The administrative law judge recommended that Helfmann pay a fine and a share of the investigative costs. The board went further, ordering that Helfmann’s license be suspended for two years, Coryell wrote. During the first year, he will not be able to practice; during the second, he can practice, but only under supervision. Helfmann also will have to pay a $10,000 civil penalty, take an ethics course and reimburse the state for some of its investigative costs. The suspension is scheduled to begin in September.

New Jersey began to investigate Helfmann after a ProPublica article published in The New York Times in December 2015 that described the lawsuits and the information they contained. The allegations involved Helfmann’s patients as well as those of his colleagues at Short Hills Associates in Clinical Psychology, a New Jersey practice where he has been the managing partner.

Helfmann is a leader in his field, serving as president of the American Group Psychotherapy Association, and as a past president of the New Jersey Psychological Association.

ProPublica identified 24 court cases filed by Short Hills Associates from 2010 to 2014 over unpaid bills in which patients’ names, diagnoses and treatments were listed in documents. The defendants included lawyers, business people and a manager at a nonprofit. In cases involving patients who were minors, the lawsuits included children’s names and diagnoses.

The information was subsequently redacted from court records after a patient counter-sued Helfmann and his partners, the psychology group and the practice’s debt collection lawyers. The patient’s lawsuit was settled.

Helfmann has denied wrongdoing, saying his former debt collection lawyers were responsible for attaching patients’ information to the lawsuits. His current lawyer, Scott Piekarsky, said he intends to file an immediate appeal before the discipline takes effect.

"The discipline imposed is ‘so disproportionate as to be shocking to one’s sense of fairness’ under New Jersey case law," Piekarsky said in a statement.

Piekarsky also noted that the administrative law judge who heard the case found no need for any license suspension and raised questions about the credibility of the patient who sued Helfmann. "We feel this is a political decision due to Dr. Helfmann’s aggressive stance" in litigation, he said.

Helfmann sued the state of New Jersey and Joan Gelber, a senior deputy attorney general, claiming that he was not provided due process and equal protection under the law. He and Short Hills Associates sued his prior debt collection firm for legal malpractice. Those cases have been dismissed, though Helfmann has appealed.

Helfmann and Short Hills Associates also are suing the patient who sued him, as well as the man’s lawyer, claiming the patient and lawyer violated a confidential settlement agreement by talking to a ProPublica reporter and sharing information with a lawyer for the New Jersey attorney general’s office without providing advance notice. In court pleadings, the patient and his lawyer maintain that they did not breach the agreement. Helfmann brought all three of these lawsuits in state court in Union County.

Throughout his career, Helfmann has been an advocate for patient privacy, helping to push a state law limiting the information an insurance company can seek from a psychologist to determine the medical necessity of treatment. He also was a plaintiff in a lawsuit against two insurance companies and a New Jersey state commission, accusing them of requiring psychologists to turn over their treatment notes in order to get paid.

"It is apparent that upholding the ethical standards of his profession was very important to him," Carol Cohen, the administrative law judge, wrote. "Having said that, it appears that in the case of the information released to his attorney and eventually put into court papers, the respondent did not use due diligence in being sure that confidential information was not released and his patients were protected."

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Several States Updated Their Existing Breach Notification Laws, Or Introduced New Laws

Given the increased usage of data in digital formats, new access methods, and continual data breaches within corporations and governments, several state governments have updated their data breach notification laws, and/or passed new laws:

Alabama

The last state without any breach notification laws, Governor Kay Ivey signed in March the state's first data breach law: the Alabama Data Breach Notification Act of 2018 (SB 318), which became effective on June 1, 2018. Some of the key modifications: a) similar to other states, the law defined the format and types of data elements which must be protected, including health information; b) defined "covered entities" including state government agencies and "third-party agents" contracted to maintain, store, process and/or access protected data; c) requires notification of affected individuals within 45 days, and to the state Attorney General; and d) while penalties aren't mandatory, the law allows civil penalties up to $5,000 per day for, "each consecutive day that the covered entity fails to take reasonable action to comply with the notice provisions of this act."

Arizona

Earlier this year, Arizona Governor Doug Ducey signed legislation updating the state's breach notification laws. Some of the key modifications: a) expanded definitions of personal information to include medical or mental health treatment/diagnosis, passport numbers, taxpayer ID numbers, biometric data, e-mail addresses in combination with online passwords and security questions; b) set the notification window for affected persons at 45 days; c) allows e-mail notification of affected persons; d) and if the breach affected more than 1,000 persons, then notification must provided to the three national credit-reporting agencies and to the state Attorney General.

Colorado

Colorado Governor John Hickenloope signed on May 29th several laws including HB-1128, which will go into effect on september 1, 2018. Some experts view HB-1128 as the strongest protections in the country. Some of the key modifications: a) expanded "covered entities" to include certain "third-party service providers" contracted to maintain, store, process and/or access protected data; b) expanded definitions of "personal information" to include biometric data, plus e-mail addresses in combination with online passwords and security questions; c) allows substitute notification methods (e.g., e-mail, post on website, statewide news media) if the cost of basic notification would exceed $250,000; d) allows e-mail notification of affected persons; e) sets the notification window at 30 days, if the breach affected more than 500 Colorado residents; and f) expanded requirements for companies to protected personal information.

Louisiana

Louisiana Governor John Edwards signed in May 2018 an amendment to the state’s Database Security Breach Notification Law (Act 382) which will take effect August 1, 2018. Some of the key modifications: a) expanded definition of ‘personal information’ to include a state identification card number, passport number, and “biometric data” (e.g., fingerprints, voice prints, eye retina or iris, or other unique biological characteristics used to access systems); b) removed vagueness and defined the notification window as within 60 days; c) allows substitute notification methods (e.g., e-mail, posts on affected company's website, statewide news media); and d) tightened required that companies utilizing "computerized data" better protect the information they archive.

South Dakota

The next-to-last state without any breach notification laws, Governor Dennis Daugaard signed into law in March the state’s first breach notification law (SB 62). Like breach laws in other states, it provides definitions of what a breach is, personal information which must be protected, covered entities (e.g., companies, government agencies) subject to the law, notification requirements, and conditions when substitute notification methods (e.g., e-mail, posts on the affected entity's website, statewide news media) are allowed.

To Summarize

New Mexico enacted its new breach notification law (HB 15) in March, 2017. With the additions of Alabama and South Dakota, finally every state has a breach notification law. Sadly, it has taken 16 years. California was the first state to enact a breach notification law in 2002. It has taken that long for other states to catch up... not only catch up with California, but also catch up with technological changes driven by the internet.

California has led the way for a long time. It banned RFID skimming in 2008, co-hosted privacy workshops with the U.S. Federal Trade Commission in 2008, strengthened its existing breach law in 2011, and introduced in 2013 privacy guidelines for mobile app developers. Other states' legislatures can learn from this leadership.

Want to learn more? Detailed reviews of new and updated breach laws are available in the National Law Review website.


Why Your Health Insurer Doesn’t Care About Your Big Bills

[Editor's note: today's guest post, by the reporters at ProPublica, discusses pricing and insurance problems within the healthcare industry, and a resource most consumers probably are unaware of. It is reprinted with permission.]

By Marshall Allen, ProPublica

Michael Frank ran his finger down his medical bill, studying the charges and pausing in disbelief. The numbers didn’t make sense.

His recovery from a partial hip replacement had been difficult. He’d iced and elevated his leg for weeks. He’d pushed his 49-year-old body, limping and wincing, through more than a dozen physical therapy sessions.

NYU Langone Health logo The last thing he needed was a botched bill.

His December 2015 surgery to replace the ball in his left hip joint at NYU Langone Medical Center in New York City had been routine. One night in the hospital and no complications.

Aetna Inc. logoHe was even supposed to get a deal on the cost. His insurance company, Aetna, had negotiated an in-network “member rate” for him. That’s the discounted price insured patients get in return for paying their premiums every month.

But Frank was startled to see that Aetna had agreed to pay NYU Langone $70,000. That’s more than three times the Medicare rate for the surgery and more than double the estimate of what other insurance companies would pay for such a procedure, according to a nonprofit that tracks prices.

Fuming, Frank reached for the phone. He couldn’t see how NYU Langone could justify these fees. And what was Aetna doing? As his insurer, wasn’t its duty to represent him, its “member”? So why had it agreed to pay a grossly inflated rate, one that stuck him with a $7,088 bill for his portion?

Frank wouldn’t be the first to wonder. The United States spends more per person on health care than any other country. A lot more. As a country, by many measures, we are not getting our money’s worth. Tens of millions remain uninsured. And millions are in financial peril: About 1 in 5 is currently being pursued by a collection agency over medical debt. Health care costs repeatedly top the list of consumers’ financial concerns.

Experts frequently blame this on the high prices charged by doctors and hospitals. But less scrutinized is the role insurance companies — the middlemen between patients and those providers — play in boosting our health care tab. Widely perceived as fierce guardians of health care dollars, insurers, in many cases, aren’t. In fact, they often agree to pay high prices, then, one way or another, pass those high prices on to patients — all while raking in healthy profits.

ProPublica and NPR are examining the bewildering, sometimes enraging ways the health insurance industry works, by taking an inside look at the games, deals and incentives that often result in higher costs, delays in care or denials of treatment. The misunderstood relationship between insurers and hospitals is a good place to start.

Today, about half of Americans get their health care benefits through their employers, who rely on insurance companies to manage the plans, restrain costs and get them fair deals.

But as Frank eventually discovered, once he’d signed on for surgery, a secretive system of pre-cut deals came into play that had little to do with charging him a reasonable fee.

After Aetna approved the in-network payment of $70,882 (not including the fees of the surgeon and anesthesiologist), Frank’s coinsurance required him to pay the hospital 10 percent of the total.

When Frank called NYU Langone to question the charges, the hospital punted him to Aetna, which told him it paid the bill according to its negotiated rates. Neither Aetna nor the hospital would answer his questions about the charges.

Frank found himself in a standoff familiar to many patients. The hospital and insurance company had agreed on a price and he was required to help pay it. It’s a three-party transaction in which only two of the parties know how the totals are tallied.

Frank could have paid the bill and gotten on with his life. But he was outraged by what his insurance company agreed to pay. “As bad as NYU is,” Frank said, “Aetna is equally culpable because Aetna’s job was to be the checks and balances and to be my advocate.”

And he also knew that Aetna and NYU Langone hadn’t double-teamed an ordinary patient. In fact, if you imagined the perfect person to take on insurance companies and hospitals, it might be Frank.

For three decades, Frank has worked for insurance companies like Aetna, helping to assess how much people should pay in monthly premiums. He is a former president of the Actuarial Society of Greater New York and has taught actuarial science at Columbia University. He teaches courses for insurance regulators and has even served as an expert witness for insurance companies.

The hospital and insurance company may have expected him to shut up and pay. But Frank wasn’t going away.

Patients fund the entire health care industry through taxes, insurance premiums and cash payments. Even the portion paid by employers comes out of an employee’s compensation. Yet when the health care industry refers to “payers,” it means insurance companies or government programs like Medicare.

Patients who want to know what they’ll be paying — let alone shop around for the best deal — usually don’t have a chance. Before Frank’s hip operation he asked NYU Langone for an estimate. It told him to call Aetna, which referred him back to the hospital. He never did get a price.

Imagine if other industries treated customers this way. The price of a flight from New York to Los Angeles would be a mystery until after the trip. Or, while digesting a burger, you’d learn it cost 50 bucks.

A decade ago, the opacity of prices was perhaps less pressing because medical expenses were more manageable. But now patients pay more and more for monthly premiums, and then, when they use services, they pay higher co-pays, deductibles and coinsurance rates.

Employers are equally captive to the rising prices. They fund benefits for more than 150 million Americans and see health care expenses eating up more and more of their budgets.

Richard Master, the founder and CEO of MCS Industries Inc. in Easton, Pennsylvania, offered to share his numbers. By most measures MCS is doing well. Its picture frames and decorative mirrors are sold at Walmart, Target and other stores and, Master said, the company brings in more than $200 million a year.

But the cost of health care is a growing burden for MCS and its 170 employees. A decade ago, Master said, an MCS family policy cost $1,000 a month with no deductible. Now it’s more than $2,000 a month with a $6,000 deductible. MCS covers 75 percent of the premium and the entire deductible. Those rising costs eat into every employee’s take-home pay.

Economist Priyanka Anand of George Mason University said employers nationwide are passing rising health care costs on to their workers by asking them to absorb a larger share of higher premiums. Anand studied Bureau of Labor Statistics data and found that every time health care costs rose by a dollar, an employee’s overall compensation got cut by 52 cents.

Master said his company hops between insurance providers every few years to find the best benefits at the lowest cost. But he still can’t get a breakdown to understand what he’s actually paying for.

“You pay for everything, but you can’t see what you pay for,” he said.

Master is a CEO. If he can’t get answers from the insurance industry, what chance did Frank have?

Frank’s hospital bill and Aetna’s “explanation of benefits” arrived at his home in Port Chester, New York, about a month after his operation. Loaded with an off-putting array of jargon and numbers, the documents were a natural playing field for an actuary like Frank.

Under the words, “DETAIL BILL,” Frank saw that NYU Langone’s total charges were more than $117,000, but that was the sticker price, and those are notoriously inflated. Insurance companies negotiate an in-network rate for their members. But in Frank’s case at least, the “deal” still cost $70,882.

With a practiced eye, Frank scanned the billing codes hospitals use to get paid and immediately saw red flags: There were charges for physical therapy sessions that never took place, and drugs he never received. One line stood out — the cost of the implant and related supplies. Aetna said NYU Langone paid a “member rate” of $26,068 for “supply/implants.” But Frank didn’t see how that could be accurate. He called and emailed Smith & Nephew, the maker of his implant, until a representative told him the hospital would have paid about $1,500. His NYU Langone surgeon confirmed the amount, Frank said. The device company and surgeon did not respond to ProPublica’s requests for comment.

Frank then called and wrote Aetna multiple times, sure it would want to know about the problems. “I believe that I am a victim of excessive billing,” he wrote. He asked Aetna for copies of what NYU Langone submitted so he could review it for accuracy, stressing he wanted “to understand all costs.”

Aetna reviewed the charges and payments twice — both times standing by its decision to pay the bills. The payment was appropriate based on the details of the insurance plan, Aetna wrote.

Frank also repeatedly called and wrote NYU Langone to contest the bill. In its written reply, the hospital didn’t explain the charges. It simply noted that they “are consistent with the hospital’s pricing methodology.”

Increasingly frustrated, Frank drew on his decades of experience to essentially serve as an expert witness on his own case. He gathered every piece of relevant information to understand what happened, documenting what Medicare, the government’s insurance program for the disabled and people over age 65, would have paid for a partial hip replacement at NYU Langone — about $20,491 — and what FAIR Health, a New York nonprofit that publishes pricing benchmarks, estimated as the in-network price of the entire surgery, including the surgeon fees — $29,162.

He guesses he spent about 300 hours meticulously detailing his battle plan in two inches-thick binders with bills, medical records and correspondence.

ProPublica sent the Medicare and FAIR Health estimates to Aetna and asked why they had paid so much more. The insurance company declined an interview and said in an emailed statement that it works with hospitals, including NYU Langone, to negotiate the “best rates” for members. The charges for Frank's procedure were correct given his coverage, the billed services and the Aetna contract with NYU Langone, the insurer wrote.

NYU Langone also declined ProPublica’s interview request. The hospital said in an emailed statement it billed Frank according to the contract Aetna had negotiated on his behalf. Aetna, it wrote, confirmed the bills were correct.

After seven months, NYU Langone turned Frank’s $7,088 bill over to a debt collector, putting his credit rating at risk. “They upped the ante,” he said.

Frank sent a new flurry of letters to Aetna and to the debt collector and complained to the New York State Department of Financial Services, the insurance regulator, and to the New York State Office of the Attorney General. He even posted his story on LinkedIn.

But no one came to the rescue. A year after he got the first bills, NYU Langone sued him for the unpaid sum. He would have to argue his case before a judge.

You’d think that health insurers would make money, in part, by reducing how much they spend.

Turns out, insurers don’t have to decrease spending to make money. They just have to accurately predict how much the people they insure will cost. That way they can set premiums to cover those costs — adding about 20 percent to for their administration and profit. If they’re right, they make money. If they’re wrong, they lose money. But, they aren’t too worried if they guess wrong. They can usually cover losses by raising rates the following year.

Frank suspects he got dinged for costing Aetna too much with his surgery. The company raised the rates on his small group policy — the plan just includes him and his partner — by 18.75 percent the following year.

The Affordable Care Act kept profit margins in check by requiring companies to use at least 80 percent of the premiums for medical care. That’s good in theory but it actually contributes to rising health care costs. If the insurance company has accurately built high costs into the premium, it can make more money. Here’s how: Let’s say administrative expenses eat up about 17 percent of each premium dollar and around 3 percent is profit. Making a 3 percent profit is better if the company spends more.

It’s like if a mom told her son he could have 3 percent of a bowl of ice cream. A clever child would say, “Make it a bigger bowl.”

Wonks call this a “perverse incentive.”

“These insurers and providers have a symbiotic relationship,” said Wendell Potter, who left a career as a public relations executive in the insurance industry to become an author and patient advocate. “There’s not a great deal of incentive on the part of any players to bring the costs down.”

Insurance companies may also accept high prices because often they aren’t always the ones footing the bill. Nowadays about 60 percent of the employer benefits are “self-funded.” That means the employer pays the bills. The insurers simply manage the benefits, processing claims and giving employers access to their provider networks. These management deals are often a large, and lucrative, part of a company’s business. Aetna, for example, insured 8 million people in 2017, but provided administrative services only to considerably more — 14 million.

To woo the self-funded plans, insurers need a strong network of medical providers. A brand-name system like NYU Langone can demand — and get — the highest payments, said Manuel Jimenez, a longtime negotiator for insurers including Aetna. “They tend to be very aggressive in their negotiations.”

On the flip side, insurers can dictate the terms to the smaller hospitals, Jimenez said. The little guys, “get the short end of the stick,” he said. That’s why they often merge with the bigger hospital chains, he said, so they can also increase their rates.

Other types of horse-trading can also come into play, experts say. Insurance companies may agree to pay higher prices for some services in exchange for lower rates on others.

Patients, of course, don’t know how the behind-the-scenes haggling affects what they pay. By keeping costs and deals secret, hospitals and insurers dodge questions about their profits, said Dr. John Freedman, a Massachusetts health care consultant. Cases like Frank’s “happen every day in every town across America. Only a few of them come up for scrutiny.”

In response, a Tennessee company is trying to expose the prices and steer patients to the best deals. Healthcare Bluebook aims to save money for both employers who self-pay, and their workers. Bluebook used payment information from self-funded employers to build a searchable online pricing database that shows the low-, medium- and high-priced facilities for certain common procedures, like MRIs. The company, which launched in 2008, now has more than 4,500 companies paying for its services. Patients can get a $50 bonus for choosing the best deal.

Bluebook doesn’t have price information for Frank’s operation — a partial hip replacement. But its price range in the New York City area for a full hip replacement is from $28,000 to $77,000, including doctor fees. Its “fair price” for these services tops out at about two-thirds of what Aetna agreed to pay on Frank’s behalf.

Frank, who worked with mainstream insurers, didn’t know about Bluebook. If he had used its data, he would have seen that there were facilities that were both high quality and offered a fair price near his home, including Holy Name Medical Center in Teaneck, New Jersey, and Greenwich Hospital in Connecticut. NYU Langone is one of Bluebook’s highest-priced, high-quality hospitals in the area for hip replacements. Others on Bluebook’s pricey list include Montefiore New Rochelle Hospital in New Rochelle, New York, and Hospital for Special Surgery in Manhattan.

ProPublica contacted Hospital for Special Surgery to see if it would provide a price for a partial hip replacement for a patient with an Aetna small-group plan like Frank’s. The hospital declined, citing its confidentiality agreements with insurance companies.

Frank arrived at the Manhattan courthouse on April 2 wearing a suit and fidgeted in his seat while he waited for his hearing to begin. He had never been sued for anything, he said. He and his attorney, Gabriel Nugent, made quiet conversation while they waited for the judge.

In the back of the courtroom, NYU Langone’s attorney, Anton Mikofsky, agreed to talk about the lawsuit. The case is simple, he said. “The guy doesn’t understand how to read a bill.”

The high price of the operation made sense because NYU Langone has to pay its staff, Mikofsky said. It also must battle with insurance companies who are trying to keep costs down, he said. “Hospitals all over the country are struggling,” he said.

“Aetna reviewed it twice,” Mikofsky added. “Didn’t the operation go well? He should feel blessed.”

When the hearing started, the judge gave each side about a minute to make its case, then pushed them to settle.

Mikofsky told the judge Aetna found nothing wrong with the billing and had already taken care of most of the charges. The hospital’s position was clear. Frank owed $7,088.

Nugent argued that the charges had not been justified and Frank felt he owed about $1,500.

The lawyers eventually agreed that Frank would pay $4,000 to settle the case.

Frank said later that he felt compelled to settle because going to trial and losing carried too many risks. He could have been hit with legal fees and interest. It would have also hurt his credit at a time he needs to take out college loans for his kids.

After the hearing, Nugent said a technicality might have doomed their case. New York defendants routinely lose in court if they have not contested a bill in writing within 30 days, he said. Frank had contested the bill over the phone with NYU Langone, and in writing within 30 days with Aetna. But he did not dispute it in writing to the hospital within 30 days.

Frank paid the $4,000, but held on to his outrage. “The system,” he said, “is stacked against the consumer.”

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Medicare Scams Still Operate. How To Avoid Getting Your Identity Information Stolen

To minimize fraud, the new Medicare cards display a unique 11-digit identification number instead of patients' Social Security numbers. However, scammers have created a new tactic to trick patients into revealing their sensitive Medicare information. The Oregon Department of Justice warned:

"If someone calls and asks you for your personal information, money to activate the new card, or threatens to cancel your Medicare benefits if you don’t share your personal information, just hang up! It is a scam," said Attorney General Ellen Rosenblum.

Medicare will not call you nor ask for your Social Security number or bank information. That's good advice for patients nationwide. Experts estimate that Medicare loses about $60 billion yearly to con artists via a variety of scams.

Oregon residents suspecting healthcare fraud or wanting to report scammers, should contact Oregon's Department of Justice’s Consumer Protection (hotline: 1-877-877-9392 or www.oregonconsumer.gov). Consumers in other states should contact their state's attorney general, and/or report suspected fraud directly to Medicare.

The video below from 2017 includes advice about how patients should protect their Medicare cards.


Connecticut And Federal Regulators Announce $1.3 Million Settlement With Substance Abuse Healthcare Provider

Connecticut and federal regulators recently announced a settlement agreement to resolve allegations that New Era Rehabilitation Center (New Era), operating in New Haven and Bridgeport, submitted false claims to both state and federal healthcare programs. The office of George Jepsen, Connecticut Attorney General, announced that New Era:

"... and its co-founders and owners – Dr. Ebenezer Kolade and Dr. Christina Kolade – are enrolled as providers in the Connecticut Medical Assistance Program (CMAP), which includes the state's Medicaid program. As part of their practice, they provide methadone treatment services for patients dealing with opioid addiction. Most of their patients are CMAP beneficiaries.

During the relevant time period, CMAP reimbursed methadone clinics by paying a weekly bundled rate that included all of the services associated with methadone maintenance, including the patient's doses of methadone; the initial intake evaluation; a physical examination; periodic drug testing; and individual, group and family drug counseling... The state and federal governments alleged that, from October 2009 to November 2013, New Era and the Kolades engaged in a pattern and practice of billing CMAP weekly for the methadone bundled service rate and then also submitting a separate claim to the CMAP for virtually every drug counseling session provided to clients by using a billing code for outpatient psychotherapy. The state and federal governments further alleged that those psychotherapy sessions were actually the drug counseling sessions already included and reimbursed through the bundled rate."

These actions were part of the State of Connecticut's Inter-agency Fraud Task Force created in 2013 to investigate and prosecute healthcare fraud. The joint investigation included the Connecticut AT's office, the office of Connecticut U.S. Attorney John H. Durham, and the U.S. Health and Human Services, Office of Inspector General – Office of Investigations.

Connecticut Fight Fraud logo Terms of the settlement agreement require NERC to pay $1,378,533 in settlement funds. Of that amount, $881,945 will be returned to CMAP.

Connecticut residents suspecting healthcare fraud or abuse should contact the Attorney General’s Antitrust and Government Program Fraud Department (phone at 860-808-5040, or email at ag.fraud@ct.gov), or the Department of Social Services fraud (hotline at 1-800-842-2155, online at www.ct.gov/dss/reportingfraud, or email at providerfraud.dss@ct.gov). Residents in other states can contact their state's attorney general's office.


Fresenius Medical Care To Pay $3.5 Million For 5 Small Data Breaches During 2012

Logo-fresenius-medical-careFresenius Medical Care Holdings, Inc. has agreed to a $3.5 million settlement agreement regarding five small data breaches the Massachusetts-based healthcare organization experienced during 2012. Fresenius Medical Care Holdings, Inc. does business under the name Fresenius Medical Care North America (FMCNA). This represents one of the largest HIPAA settlements ever by the U.S. Department of Health & Human Services (HHS).

The five small data breaches, at different locations across the United States, affected about 521 persons:

  1. Bio-Medical Applications of Florida, Inc. d/b/a Fresenius Medical Care Duval Facility: On February 23, 2012, two desktop computers were stolen during a break-in. One of the computers contained the electronic Protected Health Information (ePHI) of 200 persons, including patient name, admission date, date of first dialysis, days and times of treatments, date of birth, and Social Security number
  2. Bio-Medical Applications of Alabama, Inc. d/b/a Fresenius Medical Care Magnolia Grove: On April 3, 2012, an unencrypted USB drive was stolen from a worker's car while parked in the organization's parking lot. The USB device contained the ePHI of 245 persons, including patient name, address, date of birth, telephone number, insurance company, insurance account number (a potential social security number derivative for some patients) and the covered entity location where each patient was seen.
  3. Renal Dimensions, LLC d/b/a Fresenius Medical Care Ak-Chin: On June 18, 2012, an anonymous phone tip reported that a hard drive was missing from a desktop computer, which had been taken out of service. The hard drive contained the ePHI of 35 persons, including name, date of birth, Social Security number and Zip code. While the worker notified a manager about the missing hard drive, the manager failed t notify the FMCNA Corporate Risk Management Department.
  4. Fresenius Vascular Care Augusta, LLC: On June 16, 2012, a worker's unencrypted laptop was stolen from her car while parked overnight at home. The laptop bag also include a list of her passwords. The laptop contained the ePHI of 10 persons, including patient name, insurance account number (which could be a social security number derivative) and other insurance information.
  5. WSKC Dialysis Services, Inc. d/b/a Fresenius Medical Care Blue Island Dialysis: On or about June 17 - 18, 2012, three desktop computers and one encrypted laptop were stolen from the office. One of the desktop computers contained the ePHI of 31 persons, including patient name, dates of birth, address, telephone number, and either full or partial Social Security numbers.

Besides the hefty payment, terms of the settlement agreement (Adobe PDF) require FMCNA to implement and complete a Corrective Action Plan:

  • Conduct a risk analysis,
  • Develop and implement a risk management plan,
  • Implement a process for evaluating workplace operational changes,
  • Develop an Encryption Report,
  • Review and revise internal policies and procedures to control devices and storage media,
  • Review and revise policies to control access to facilities,
  • Develop a privacy and security awareness training program for workers, and
  • Submit progress reports at regular intervals to HHS.

The Encryption report identifies and describes the devices and equipment (e.g., desktops, laptops, tables smartphones, etc.) that may be used to access, store, and transmit patients' ePHI information; records the number of devices including which utilize encrypted information; and provides a detailed plan for implementing encryption on devices and media which should contain encrypted information and currently don't.

Some readers may wonder why a large fine for relatively small data breaches, since news reports often cite data breaches affecting thousands or millions of persons. HHS explained that the investigation by its Office For Civil Rights (OCR) unit:

"... revealed FMCNA covered entities failed to conduct an accurate and thorough risk analysis of potential risks and vulnerabilities to the confidentiality, integrity, and availability of all of its ePHI. The FMCNA covered entities impermissibly disclosed the ePHI of patients by providing unauthorized access for a purpose not permitted by the Privacy Rule... Five breaches add up to millions in settlement costs for entity that failed to heed HIPAA’s risk analysis and risk management rules.."

OCR Director Roger Severino added:

"The number of breaches, involving a variety of locations and vulnerabilities, highlights why there is no substitute for an enterprise-wide risk analysis for a covered entity... Covered entities must take a thorough look at their internal policies and procedures to ensure they are protecting their patients’ health information in accordance with the law."


Health Experts To Facebook: Turn Off Messenger Kids

Facebook logo In December 2017, Facebook launched its Messenger Kids service for children ages six to 13. The service includes a free video calling and messaging app where children can connect only with parent-approved contacts. The ad-free service includes masks, frames, stickers and GIFs for children to, "ids can create fun videos and decorate photos to share moments with loved ones."

Pediatricians and health experts are very concerned. Earlier today, dozens of health professionals sent a letter to Facebook (Adobe PDF) urging the social networking giant to terminate Messenger Kids. The letter stated in part:

"Given Facebook’s enormous reach and marketing prowess, Messenger Kids will likely be the first social media platform widely used by elementary school children. But a growing body of research demonstrates that excessive use of digital devices and social media is harmful to children and teens, making it very likely this new app will undermine children’s healthy development.

Younger children are simply not ready to have social media accounts. They are not old enough to navigate the complexities of online relationships, which often lead to misunderstandings and conflicts even among more mature users. They also do not have a fully developed understanding of privacy, including what’s appropriate to share with others and who has access to their conversations, pictures, and videos.

At a time when there is mounting concern about how social media use affects adolescents’ well being, it is particularly irresponsible to encourage children as young as preschoolers to start using a Facebook product. Social media use by teens is linked to significantly higher rates of depression, and adolescents who spend an hour a day chatting on social networks report less satisfaction with nearly every aspect of their lives. Eighth graders who use social media for 6 - 9 hours per week are 47% more likely to report they are unhappy than their peers who use social media less often. A study of girls between the ages of 10 and 12 found the more they used social networking sites like Facebook, the more likely they were to idealize thinness, have concerns about their bodies, and to have dieted. Teen social media use is also linked to unhealthy sleep habits. Messenger Kids is likely to increase the amount of time pre-school and elementary age kids spend with digital devices. Already, adolescents report difficulty moderating their own social media use: 78% check their phones at least hourly, and 50% say they feel addicted to their phones. Almost half of parents say that regulating their child’s screen time is a constant battle. Messenger Kids will exacerbate this problem... Encouraging kids to move their friendships online will interfere with and displace the face-to-face interactions and play that are crucial for building healthy developmental skills, including the ability to read human emotion, delay gratification, and engage with the physical world..."

The letter contains footnotes to citations with supporting research about the above health concerns. Reportedly, Facebook consulted with the National PTA and several academics before introducing the app. Messenger Kids is a separate service, so children using it can't be found using Facebook's search mechanism.

The letter from health professionals to Facebook also addressed safety concerns:

"Facebook claims that Messenger Kids will provide a safe alternative for the children who have lied their way onto social media platforms designed for teens and adults. But the 11- and 12-year-olds who currently use Snapchat, Instagram, or Facebook are unlikely to switch to an app that is clearly designed for younger children. Messenger Kids is not responding to a need – it is creating one. It appeals primarily to children who otherwise would not have their own social media accounts. It is disingenuous to use Facebook’s failure to keep underage users off their platforms as a rationale for targeting younger children with a new product."

Earlier this month, Facebook's CEO acknowledged problems and promised to do better. We shall see if Facebook's management listens to the documented concerns of pediatricians and health professionals.

What are your opinions about children ages 6 to 13 using social media? About Messenger Kids? Should Facebook terminate Messenger Kids?

Facebook-messenger-kids-how-to


Some U.S. Hospitals Don’t Put Americans First for Liver Transplants

[Editor's note: today's guest blog post, by the reporters at ProPublica, discusses a largely unknown practice by some hospitals in the health care industry. Is this practice right? Ethical? Today's post is reprinted with permission.]

By Charles Ornstein, ProPublica

Earlier this fall, a leader of the busiest hospital for organ transplants in New York state — where livers are particularly scarce — pleaded for fairer treatment for ailing New Yorkers.

“Patients in equal need of a liver transplant should not have to wait and suffer differently because of the U.S. state where they reside,” wrote Dr. Herbert Pardes, former chief executive and now executive vice president of the board at NewYork-Presbyterian Hospital.

But Pardes left out his hospital’s own contribution to the shortage: From 2013 to 2016, it gave 20 livers to foreign nationals who came to the United States solely for a transplant — essentially exporting the organs and removing them from the pool available to New Yorkers.

That represented 5.2 percent of the hospital’s liver transplants during that time, one of the highest ratios in the country.

Little known to the public, or to sick patients and their families, organs donated domestically are sometimes given to patients flying in from other countries, who often pay a premium. Some hospitals even seek out foreign patients in need of a transplant. A Saudi Arabian company, Ansaq Medical Co., whose stated aim is to “facilitate the procedures and mechanisms of ‘medical tourism,’” said it signed an agreement with Ochsner Medical Center in New Orleans in 2015.

The practice is legal, and foreign nationals must wait their turn for an organ in the same way as domestic patients. Transplant centers justify it on medical and humanitarian grounds. But at a time when President Donald Trump is espousing an “America First” policy and seeking to ban visitors and refugees from certain countries, allocating domestic organs to foreigners may run counter to the national mood.

Even beyond the realm of health care, some are questioning whether foreigners should be able to access limited spots that might otherwise be available to U.S. citizens. For instance, public colleges compensate for reductions in state funding by accepting more foreign students paying higher tuition, and critics say in-state students are being denied opportunities as a result.

Dr. Sander Florman, director of the transplant institute at the Mount Sinai Hospital in New York, said he struggles with “in essence, selling the organs we do have to foreign nationals with bushels of money.”

Mount Sinai has not performed any transplants on patients who came to this country specifically for that purpose, but it has done so for international patients here for other reasons.

Between 2013 and 2016, 252 foreigners came to the U.S. purely to receive livers at American hospitals. In 2016, the most recent year for which data is available, the majority of foreign recipients were from countries in the Middle East, including Saudi Arabia, Kuwait, Israel and United Arab Emirates. Another 100 foreigners staying in the U.S. as non-residents also received livers.

All the while, more than 14,000 people, nearly all of them American citizens, are waiting for liver transplants, a figure that has remained stubbornly high for decades. By comparison, fewer than 8,000 liver transplants were performed last year in the United States — and that was an all-time high. The national median wait time for a liver is more than 14 months, and in states like New York, the wait is far longer. (The wait for livers varies from one state to the next, depending on such factors as the number of organ donors, and the resourcefulness of organ procurement agencies.)

Many patients die before reaching the front of the line. In 2016, more than 2,600 patients were removed from waiting lists nationally because they either died or were too sick to receive a liver transplant.

Most transplant centers only serve American citizens or residents, either by happenstance or by design. Foreign transplants are concentrated among a handful of centers, including NewYork-Presbyterian, Memorial Hermann-Texas Medical Center in Houston (31 such transplants from 2013 to 2016), Ochsner (30), and Cleveland Clinic in Ohio (21).

“When you take people from other parts of the world and provide an organ transplant to them rather than someone who’s here, there’s a real cost, there’s a real life that’s lost,” said Jane Hartsock, a visiting assistant professor of medical humanities and health studies at the Indiana University School of Liberal Arts. Hartsock and her colleagues wrote a journal article published last year saying foreigners should be last in line for a transplant.

NewYork-Presbyterian said it does not advertise its transplant program to foreign patients and that the majority of the transplants it performed on foreign nationals traveling to New York for that reason — 11 of the 20 — were on children under 18.

In a statement, the hospital and its academic partner Columbia University said they follow federal guidelines. “We strongly support efforts that aim to address the critical issue of equitable distribution of livers for transplant and are working closely with a wide range of stakeholders to help increase the number of organ donor registrations in New York State.”

A spokeswoman for the Cleveland Clinic, Eileen Sheil, said her hospital does not actively seek out foreign national business and has a “thoughtful and ethical approach that is well within the rules and aligned with our overall mission for taking care of patients.” Ochsner similarly said, “patients seek out Ochsner’s expertise because of our relentless commitment to provide the highest-quality, complex care.” Memorial Hermann did not respond to requests for comment.

To be sure, the proportion of available livers that go to foreigners is tiny — slightly less than 1 percent of liver transplants nationwide from 2013 to 16. The figure appears to be dropping further in 2017. Even if all recipients were Americans, wait times would still be substantial. Moreover, foreigners queue up on the waitlist like everybody else — although it may be easier for them, since they aren’t rooted in any particular state, to choose a hospital in an area with a shorter wait, such as Ochsner. And some Americans discouraged by the lengthy wait in this country have gone abroad for transplants.

The transplant figures in this article do not include transplants involving living donors, meaning a relative or friend who donates part of his or her liver to a patient. No one interviewed for this story said it is inappropriate for a foreign national to come to the U.S. for a procedure with a living donor.

There’s also an important distinction between giving an organ to a foreigner who happens to be in the U.S. — someone on a student visa or even an undocumented immigrant — and giving one to someone flying over just for surgery. Someone in the first group would be eligible to donate an organ if something happened to them in this country; someone in the latter group would not because livers must be transplanted quickly and there wouldn’t be enough time to ship them.

“If you live in the United States, no matter what your [citizenship] status is, you could potentially be an organ donor if you get hit by a car or something happens to you,” said Dr. Gabriel M. Danovitch, medical director of the kidney and pancreas transplant program at Ronald Reagan UCLA Medical Center, who previously led the UNOS international relations committee. “But if your home is somewhere else, a long way away, there’s no way that you can be a donor or your family or your friends could be donors.

“And in some respects, when you then come to the United States, you are using up a valuable resource that is in great shortage here.”

Foreign patients generally are not entitled to the same discounts as those with private insurance or Medicare, the federal insurance program for seniors and the disabled. In 2015, for instance, the average sticker price for a liver transplant at NewYork-Presbyterian was $371,203, but the average payment for patients in Medicare was less than one-third of that, $112,469, according to data from the Centers for Medicare and Medicaid Services, which runs Medicare. In the case of Saudi Arabia, its embassy in Washington often guarantees payment for patients.

The topic is emerging now because the nation’s transplant leaders will meet next month to consider rewriting the rules governing how livers are distributed, giving programs in New York City, Los Angeles, Chicago and other areas greater access to organs from people who die in nearby regions. The proposal by a committee of the United Network for Organ Sharing, the federal contractor that runs the national transplant system, faces opposition from programs and regions that stand to lose organs. Pardes’ comments were posted in an online comment forum devoted to the proposal, which does not address the issue of transplants for foreigners.

UNOS said it has worked to get better data on foreigners that receive transplants in this country but ultimately, federal law doesn’t prohibit these transplants.

“This is an individual medical decision that the individual transplant hospital makes,” spokesman Joel Newman said. “If we addressed citizenship or residency as a particular reason for whether to accept a patient or not, then that would open up the door to lots of other nonmedical criteria — religion, race, political preference, any number of things that as a community we have decided from an ethical standpoint not to consider.”

UNOS has the authority to ask questions of transplant centers about surgeries on foreign nationals, but Newman said UNOS committees are still trying to figure out what information they would want, and, in any event, the transplant centers don’t have to answer the questions.

The federal rules governing the transplant system, written more than three decades ago, say organ allocation decisions must be based on medical criteria, which would exclude consideration of a person’s nationality or citizenship. While centers can perform as many transplants on foreigners as they want, many programs have tried to keep them below 5 percent of all transplants for each organ type. Until several years ago, 5 percent was the threshold above which UNOS could audit a program. No programs were ever formally audited, and the cutoff was eventually eliminated.

It’s time to revisit the rules, some lawmakers say.

“As a general rule, you’ve got to take care of Americans first as long as you have more demand than supply,” said Sen. John Kennedy, R-La., whose state is home to Ochsner, a leader in transplants for foreign nationals. Kennedy said he would favor curbing transplants for foreigners, while creating a national board that could make exceptions. “But what you don’t want to get into, it seems to me, is subjective areas like well, ‘If this person could live an extra few years, what could they contribute to society?’”

There have been scandals in the past about foreigners and organ transplants. In 2005, a liver transplant center in Los Angeles shut its doors after disclosing that its team had taken a liver that should have gone to a patient at another hospital and instead had implanted it in a Saudi national. The hospital said its staff members falsified documents to cover up the incident.

The University of California, Los Angeles, came under fire in 2008 for performing liver transplants on a powerful Japanese gang boss and other men linked to Japanese gangs, and then receiving donations afterward from at least two of the men. The hospital and its surgeon said they do not make moral judgments about patients.

Further complicating matters is a 2008 document endorsed by transplant organizations around the world, called the Declaration of Istanbul, which seeks to eliminate organ trafficking and reduce transplant tourism internationally. One concern was that patients went to China and received transplants using organs from prisoners. (China said it was stopping the practice in 2015, but experts question whether that has happened.) Another concern was that if a country’s wealthiest or most powerful residents could get transplants overseas, its leaders may not have an incentive to set up a system of their own.

The non-binding declaration also says that there should be a ban on “soliciting, or brokering for the purpose of transplant commercialism, organ trafficking, or transplant tourism.” It was endorsed by UNOS and other national transplant groups.

Former Ochsner employees say they recall Saudi nationals coming for transplants, some wealthy and some not. A New Orleans bar posted a photo on Facebook in 2015 of a young man who brought his mom from Saudi Arabia for a transplant.

Ochsner said in a statement that it was proud of its liver transplant program, which is the nation’s largest. It said that it is willing to accept donated organs that other centers turn down for medical reasons, expanding its ability to help patients while keeping its survival rate high. And it noted that the median waiting time for its patients is only 2.1 months, far below the national median.

“UNOS does not have any restrictions preventing transplant for international patients and they are subject to the same guidelines as domestic patients,” the statement said.

Still, many American candidates for livers don’t make Ochsner’s waiting list. It refused to put Brian “Bubba” Greenlee Jr. on its list right after Christmas in 2015, because of his “poor insight into his drinking and lack of proper social support,” his medical records show. He had cirrhosis and died weeks later at age 45.

His sister, Theresa Greenlee-Jeffers, said Ochsner led her brother to believe that he would get a new liver. Her brother had stopped drinking and she had volunteered to take care of him after a transplant, but then the hospital suddenly reversed course.

“His last Christmas, he was given false hope that he was going to get a transplant. That’s not OK. You don’t play with somebody’s emotions like that,” Greenlee-Jeffers said.

Ocshner did not answer questions about Greenlee’s care but said in its statement, “Not every patient is a candidate for transplant.” It said its criteria are similar to those of other liver transplant centers.

“At Ochsner, we are caregivers, dedicated to providing our patients with high-quality care, improved outcomes and the gift of a second chance at life,” its statement said.

Greenlee-Jeffers wonders if Ochsner excluded her brother and other Americans to make room for foreigners willing to pay more. “It’s not OK,” she said. “We need to take care of our people here at home first. We don’t have enough of this to go around.”

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Consequences And New Threats From The Massive Equifax Breach

Equifax logo To protect themselves and their sensitive information, many victims of the massive Equifax data breach have signed up for the free credit monitoring and fraud resolution services Equifax arranged. That's a good start. Some victims have gone a step further and placed Fraud Alerts or Security Freezes on their credit reports at Equifax, Experian, and TransUnion. That's good, too. But, is that enough?

The answer to that question requires an understanding of what criminals can do with the sensitive information accessed stolen during the Equifax breach. Criminals can commit types of fraud which credit monitoring, credit report alerts, and freezes cannot stop. Consumer Reports (CR) explained:

"Freezing your credit report specifically at Equifax will also prevent crooks from registering as you at the government website, my Social Security, and block them from attempting to steal your Social Security benefits. But taking these steps won't protect you against every identity fraud threat arising from the Equifax data breach."

Sadly, besides credit and loan fraud the Equifax breach exposed breach victims to tax refund fraud, health care fraud, and driver's license (identity) fraud. This is what makes the data breach particularly nasty. CR also listed the data elements criminals use with each type of fraud:

"With your Social Security number, crooks can file false income tax returns in your name, take bogus deductions, and steal the resulting refund. More than 14,000 fraudulent 2016 tax returns, with $92 million in unwarranted refunds, were detected and stopped by the Internal Revenue Service (IRS) as of last March... Data from the Equifax breach can be used to steal your benefits from private health insurance, Medicare, or Medicaid when the identity thief uses your coverage to pay for his own medical treatment and prescriptions... Using your driver’s license number, identity thieves can create bogus driver’s licenses and hang their moving violations on you...."

The CR article suggested several ways for consumers to protect themselves from each type of fraud: a) request an Identity Protection PIN number from the IRS; b) request copies of your medical file from your providers and review your MIB Consumer File each year; and c) request a copy of your driving license record and get your free annual consumer report from ChexSystemsCertegy, and TeleCheck -  the three major check verification companies.

Never considered reviewing your tax account with the IRS? You can. Never heard of a Consumer MIB File? I'm not surprised. Most people haven't. I encourage consumers to read the entire CR article. While at the CR site, read their review of TrustedID Premier service which Equifax arranged for breach victims. It's an eye-opener.

Do these solutions sound like a lot of preventative work? They are. You have Equifax to thank for that. Will Equifax help breach victims with the time and effort required to research and implement the solutions CR recommended? Will Equifax compensate breach victims for the costs incurred with these solutions? These are questions breach victims should ask Equifax and TrustedID Premier.

Consumers and breach victims are slowly learning the consequences of a data breach are extensive. The consequences include time, effort, money, and aggravation. You might say breach victims have been mugged. Worse, consumers are saddled the burden from the consequences. That isn't fair. The companies making money by selling consumers' credit reports and information should be responsible for the burdens. Things are out of balance.

What are your opinions?


'If You Hemorrhage, Don't Clean Up': Advice From Mothers Who Almost Died

[Editor's note: today's guest post is part of the ongoing "Lost Mothers" investigation by ProPublica because, "The U.S. has the highest rate of deaths related to pregnancy and childbirth in the developed world. Half of the deaths are preventable, victimizing women from a variety of races, backgrounds, educations and income levels." It is reprinted with permission.]

by Adriana Gallardo and Nina Martin, ProPublica, and Renee Montagne, NPR

Four days after Marie McCausland delivered her first child in May, she knew something was very wrong. She had intense pain in her upper chest, her blood pressure was rising, and she was so swollen that she barely recognized herself in the mirror. As she curled up in bed that evening, a scary thought flickered through her exhausted brain: "If I go to sleep right now, I don't know if I'm gonna be waking up."

What she didn't have was good information about what might be wrong. The discharge materials the hospital sent her home with were vague and confusing -- "really quite useless," she said. Then she remembered a ProPublica/NPR story she'd recently read about a New Jersey nurse who died soon after childbirth. Lauren Bloomstein had developed severe preeclampsia, a dangerous type of hypertension that often happens during the second half of her pregnancy. But it can also emerge after the baby is delivered, when it is often overlooked -- accounting for dozens of maternal deaths a year. McCausland realized that she might have preeclampsia, too.

The 27-year-old molecular virologist and her husband bundled up their newborn son and raced to the nearest emergency room in Cleveland. But the ER doctor told her that she was feeling normal postpartum symptoms, she said. Even as her blood pressure hovered at perilous heights, he wanted to send her home. Several hours passed before he consulted with an OB-GYN at another hospital and McCausland's severe preeclampsia was treated with magnesium sulfate to prevent seizures. Without Bloomstein's story as a warning, McCausland doubts she would have recognized her symptoms or persisted in the face of the ER doctor's dismissiveness. "I had just come home with the baby and really didn't want to go back to the hospital. I think I probably would have just wrote it off." In that case, she added, "I don't know if I'd be here. I really don't."

McCausland's experience is far from unique. In the months since ProPublica and NPR launched our project about maternal deaths and near-deaths in the U.S., we've heard from 3,100 women who endured life-threatening pregnancy and childbirth complications, often suffering long-lasting physical and emotional effects. (Tell us your story.)

The same themes that run though McCausland's story echo through many of these survivors' recollections. They frequently told us they knew little to nothing beforehand about the complications that nearly killed them. Even when the women were convinced something was terribly amiss, doctors and nurses were sometimes slow to believe them. Mothers especially lacked information about risks in the postpartum period, when medical care is often disjointed or difficult to access and the baby is the focus of attention. "Every single nurse, pediatrician, and lactation consultant dismissed my concerns as hormones and anxiety," wrote Emily McLaughlin, who suffered a stroke and other complications after giving birth in Connecticut in 2015.

These survivors make up an important, and largely untapped, source of knowledge about the dangers that expectant and new mothers may face -- and how to avoid disaster. Every day in the U.S., two to three women die from pregnancy- or childbirth-related causes, including preeclampsia, hemorrhage, infection, blood clots and cardiac problems -- the highest rate of maternal mortality among wealthy nations. As many as 60 percent of these deaths are preventable, a new report suggests; more than half occur after delivery. (See our story on the lost mothers of 2016.) Each day, another 175 women suffer complications severe enough to require major medical intervention such as massive transfusions, emergency surgery or admission to an intensive care unit -- equivalent to about 65,000 close calls annually, according to the Centers for Disease Control and Prevention.

Hospitals, medical organizations and maternal safety groups are introducing a host of initiatives aimed at educating expectant and new mothers and improving how providers respond to emergencies. But as McCausland's experience illustrates, self-advocacy is also critically important.

We asked survivors: What can people do to ensure that what happened to Lauren Bloomstein doesn't happen to them or their loved ones? How can they help prevent situations like Marie McCausland's from spiraling out of control? What do they wish they had known ahead of their severe complications? What made a difference in their recovery? How did they get medical professionals to listen? Here is a selection of their insights, in their own words.

Choosing a Provider

"A lot of data on specific doctors and hospitals can be found publicly. Knowing how your physician and hospital rates as compared to others (cesarean rates, infection rates, readmission rates) can give you valuable insight into how they perform. 'Liking' your doctor as a person is nice, but not nearly as important as their and their facility's culture and track record."

-- Kristen Terlizzi, 35, survivor of placenta accreta (a disorder in which the placenta grows into or through the uterine wall) in 2014 and cofounder of the National Accreta Foundation

"Key pieces of information every woman should know before choosing a hospital are: What are their safety protocols for adverse maternal events? No one likes to think about this while pregnant, and providers will probably tell you that it's unlikely to happen. But it does happen and it's good to know that the hospital and providers have practiced for such scenarios and have proper protocols in place."

-- Marianne Drexler, 39, survived a hemorrhage and emergency hysterectomy in 2014

"Ask your doctors if they have ever experienced a case of an amniotic fluid embolism [an abnormal response to amniotic fluid entering the mother's bloodstream] or other severe event themselves. If a birthing center is your choice, discuss what happens in an emergency -- how far away is the closest hospital with an ICU? Because a lot of hospitals don't have them. Another thing many women don't realize is that not every hospital has an obstetrician there 24/7. Ask your doctors: If they're not able to be there the whole time you're in labor, will there be another ob/gyn on site 24 hours a day if something goes wrong?"

-- Miranda Klassen, 41, survivor of amniotic fluid embolism in 2008 and founder/executive director of the Amniotic Fluid Embolism Foundation

"While my doctor was amazing, we live in a smaller town and they don't carry enough blood/platelets on hand for very emergent situations. They have patients shipped to larger hospitals when they need more care. Had I been aware of that we would have decided to deliver at a larger hospital so in case something happened to me or our daughter we wouldn't be separated, which we were when I was life-flighted out."

-- Kristina Landrus, 26, survived a hemorrhage in 2013

"My best advice for getting a medical professional to listen is to keep searching for one that is willing to listen. Because of my insurance and personal circumstances at the time I felt I had no option but to take whoever my providers [assigned] me, despite several red flags even before my delivery. I was not aware of my right to change providers until it was too late."

-- Joy Huff, 39, survived a blood infection in 2013

Preparing for an Emergency

"A conversation about possible things that could go wrong is prudent to have with your doctor or in one of these childbirth classes. I don't think that it needs to be done in a way to terrify the new parents, but as a way to provide knowledge. The pregnant woman should be taught warning signs, and know when to speak up so that she can be treated as quickly and accurately as possible."

-- Susan Lewis, 33, survived multiple blood clots and severe hemorrhage in 2016

"Always have somebody with you in a medical setting to ask the questions you might not think of and to advocate on your behalf if your ability to communicate is compromised by being in poor health. ... And get emotional support to steel you against the naysayers. It may feel really unnatural or difficult to push back [against doctors and nurses]. Online forums and Facebook groups can be helpful to ensure you're not losing your mind."

-- Eleni Tsigas, survivor of preeclampsia in 1998 and 1999 and executive director of the Preeclampsia Foundation

"Know your rights. Know what kind of decisions you might have to make and what you want to do before you go. Doctors and nurses are there to make quick decisions, they're not worried about how you will feel about it afterward. They are worried about a lawsuit, whether they can get you stable quickly so they can move on. I'm not saying they are heartless, far from it. My mother is a nurse, I know what sort of heart goes into that profession. But they have a lot to do and a lot to worry about, your feelings are not at the top of that list. At least not as far as they are concerned in the moment."

-- Carrie Anthony, 36, survived two pregnancies with placenta accreta and hemorrhage in 2008 and 2015

"It isn't just important to know how you feel about blood transfusions and life-saving measures 2014 you have to communicate these things to your spouse or family member. I was given six blood transfusions, but I was barely conscious when asked if I wanted them. Of course, I wanted any life-saving measures, but my husband should have been consulted, given that I was not of a clear mind."

-- Rachel Stuhler, 36, survived a hemorrhage in 2017

"In case you ever are unable to respond, someone needs to step in and be your voice! Know as much thorough medical history as possible, and let your spouse or support person know [in depth] your history as well."

-- Kristina Landrus

"Also be sure your spouse and your other family members, like your parents or siblings, are on the same page about your care. And if you aren't married, who will be making the decisions on your behalf? You should put things in order, designate the person who will be the decision maker, and give that person power of attorney. Other important things to have are a medical directive or a living will 2014 be sure to bring a copy with you to the hospital. I also recommend packing a journal to record everything that happens."

-- Miranda Klassen

"Make a list of your questions and make sure you get the full answer. I went to every appointment the second time around with a notebook. I would apologize for being 'that patient,' but I had been through this before and I wasn't going to be confused again. I wanted to know everything. Honestly, it was as harmful as it was helpful. I knew what I was getting into, which made it much scarier. The first time, my ignorance was bliss. I didn't realize I almost died until two weeks after I had left the hospital. I didn't even start researching what had happen to me until months later. The second time I was an advocate for myself. Medical journals and support groups were a part of every single visit. And thankfully, I was in good hands."

-- Carrie Anthony

"Write down what each specialty says to you. When I was hospitalized for six weeks prior to giving birth, I was visited 2-3 times a week by someone from each department that would be involved in my life-saving surgery. This means that I saw someone from the neonatal intensive care unit as well as reps from gynecologic oncology, maternal fetal medicine, interventional radiology and anesthesiology. They paraded in on a schedule, checked up on me, asked if I had any questions. I always did, but I regret not writing down what each said each time (along with names!). I got so many different answers regarding how I would be anesthetized, and on the day it all had to happen in an emergency, there were disagreements above me in the OR. between the specialists. It was like children arguing on a playground and my life was in danger. Had I kept a more vigilant record of what each specialty reported to me, perhaps prior to the day I could have confronted each with the details that weren't matching up."

-- Megan Moody, 36, survived placenta percreta (when the placenta penetrates through the uterine wall) in 2016

"People should know that they have a right to ask for more time with the doctor or more follow up if they feel something is not right. The ob-gyns (at least in Pennsylvania) are so busy and sometimes appointments are quite quick and rushed. Make the doctors slow down and take the time with you."

-- Dani Leiman, 37, survived HELLP syndrome (a particularly dangerous variant of preeclampsia) in 2011

"You have a legal right to your medical records throughout pregnancy and anytime afterwards. Get a copy of your lab results each time blood is drawn, and a copy of your prenatal and hospital reports. Ask about concerning or unclear results."

-- Eleni Tsigas

Getting Your Provider to Listen

"Understand the system. Ask a nurse or a trusted loved one in the 'industry' how it all works. I've found that medical professionals are more likely to listen to you if you demonstrate an understanding of their roles and the kind of questions they can/cannot answer. Know your 'silos.' Don't ask an anesthesiologist how they plan on stitching up your cervix. Specialists are often incredibly impatient. You need to get the details out of them regarding their very specific roles."

-- Megan Moody

"Let doctors know you care about your health and safety as much as they do. Tell them you want to be a partner in your health care. Do not act as an adversary to your doctor."

-- Tricia Fitzgerald, 40, survived a hemorrhage caused by severe preeclampsia in 2014

"First you have to be armed with concrete knowledge with examples about your illness and have a firm attitude. This is why it is important to know your body. Do your research before your appointment, but make it personal. Do not present your case as if you just went on WebMD for the information. Create a log of your health activities. This log should contain all illnesses you are concerned about, when they occurred and how did you feel. Have your questions and concerns written down. You should always carry a list of your medications, dosage, and milligrams. Include any side effects. Ask concrete questions and have the doctors present their findings to you in a language you can understand. If you do not agree [with what one doctor tells you], ask another doctor. Remember, knowledge is power and you must have that power."

-- Anner Porter, 55, survivor of peripartum cardiomyopathy in 1992 and founder of the advocacy organization Fight PPCM

"If your provider tells you, 'You are pregnant. What you're experiencing is normal,' remember -- that may be true. [But it's also true] that preeclampsia can mimic many normal symptoms of pregnancy. Ask, 'What else could this be?' Expect a thoughtful answer that includes consideration of 2018differential diagnoses' -- in other words, other conditions that could be causing the same symptoms."

-- Eleni Tsigas

"They only listen if the pain is a 10 or higher. Most of us don't understand what a 10 is. I'd always imagined a 10 would feel like having a limb blown off in combat. When asked to evaluate your pain on a scale of 1 to 10, when you are in your most vulnerable moment, it is very hard to assess this logically, for you and for your partner witnessing your pain. I later saw a pain chart with pictures. A 10 was demonstrated with an illustration of a crying face. You may not actually be shedding tears, but you are most likely crying on the inside in pain, so I suggest to always say a 10. My pain from the brain hemorrhage was probably a 100, but I'm not sure if I even said 10 at the time."

-- Emily McLaughlin, 34, survived a postpartum stroke in 2015

"Crying! I'm only slightly kidding. I truly think the only way to get them to listen is to be adamant and don't back down. I had a situation where I felt no one was paying attention to me, and I cried out of frustration over the phone. Then they listened to me and snapped into action."

-- Dani Leiman

"So many women do speak up about the strange pain they have, and a nurse may brush it off as normal without consulting a doctor and running any tests. Be annoying if you must, this is your life. ... Thankfully, I never had to be so assertive. I owe my life to the team of doctors and nurses who acted swiftly and accurately, and I am eternally grateful."

-- Susan Lewis

"If you have a hemorrhage, don't clean up after yourself! Make sure the doctor is fully aware of how much blood you are losing. I had a very nice nurse who was helping to keep me clean and helping to change my (rapidly filling) pads. If the doctor had seen the pools of blood himself, rather than just being told about them, he might not have been so quick to dismiss me."

-- Valerie Bradford, 30, survived hemorrhage in 2016

Paying Attention to Your Symptoms

"I had heard of preeclampsia but I was naïve. [I believed] that it was something women developed who didn't watch what they ate and didn't focus on good health prior and/or during pregnancy. I was in great health and shape prior to getting pregnant, during my pregnancy I continued to make good food choices and worked out up until 36 hours before the baby had to be taken. I gained healthy weight and kept my BMI at an optimum number. I thought due to my good health, I was not susceptible to anything and my labor would be easy. So although I had felt bad for 1 1/2 weeks, I chalked it up to the fact that I was almost 8 months into this pregnancy, so you're not supposed to feel great. 2026 I walked into my doctor's office that Friday and not one hour later I was in an emergency C-section delivering a baby. I had to fully be put under due to the severity of the HELLP, so I didn't wake up until the next day."

-- Kelli Davis, 31, survived HELLP syndrome in 2016

"Understand that severe, sustained pain is not normal. So many people told me that the final trimester of pregnancy is sooo uncomfortable. It was my first pregnancy, I have a generally high threshold for pain, and my son was breech so I thought his head was causing bad pain under my ribs [when it was really epigastric pain from the HELLP syndrome]. I kept thinking it was normal to be in pain and I let it go until it was almost too late."

-- Dani Leiman

"I wish I would have known what high blood pressure numbers were. I had a pharmacist take my blood pressure at a pharmacy and let me walk out the door with a blood pressure of 210/102. She acted like it was no big deal ('it's a little high'), and so I believed her. Even after telling my husband, we really thought nothing of it."

-- Melissa McFadden, 36, survived preeclampsia in 2013

"Know the way your blood pressure should be taken. And ask for the results. Politely challenge the technician or nurse if it's not being done correctly or if they suggest 'changing positions to get a lower reading.' Very high blood pressure (anything over 160/110) is a 'hypertensive crisis' and requires immediate intervention."

-- Eleni Tsigas

"Please ask for a heart monitor for yourself while in labor, not just for the baby. I think if I had one on, seconds or minutes could have been erased from reaction time by the nurses. They were alerted to an issue because the baby's heart stopped during labor, and while the nurse was checking that machine, my husband noticed I was also non-responsive. That's when everything happened (cardiac arrest due to AFE)."

-- Kristy Kummer-Pred, 44, survived amniotic fluid embolism and cardiac arrest in 2012

After the Delivery

"My swelling in my hands and feet never went away. My uterus hadn't shrunk. I wasn't bleeding that bad, but there was a strange odor to it. My breasts were swollen and my milk wasn't coming in. I was misdiagnosed with mastitis [a painful inflammation of the breast tissue that sometimes occurs when milk ducts become plugged and engorged]. The real problem was that I still had pieces of placenta inside my uterus. Know that your placenta should not come out in multiple pieces. It should come out in one piece. If it is broken apart, demand an ultrasound to ensure the doctors got it all. If you have flu-like symptoms, demand to be seen by a doctor. If you don't like your doctor, demand another one."

-- Brandi Miller, 32, survived placenta accreta and hemorrhage in 2015

"There is a period in the days and weeks after delivery where your blood pressure can escalate and you can have a seizure, stroke, or heart attack, even well after a healthy birth. You should take your own blood pressure at home if your doctor doesn't tell you to. ... Unfortunately, I went home from [all my postpartum] appointments with my blood pressure so high that I started having a brain hemorrhage. Not one single person ever thought of taking my blood pressure when I was complaining about my discomfort and showing telltale warning signs of [preeclampsia]."

-- Emily McLaughlin

"The ER doctor that I had was not treating me as a postpartum case. He was just thinking of me as a 27-year-old with high blood pressure. I think, if you have the opportunity, the ideal thing would be to go back to the same hospital where you had your baby, because they have a labor and delivery unit and they have your records. But if the closest emergency room isn't at the hospital where you delivered, then you have to be more vigilant. Make sure they know you just gave birth. If you know something is wrong with you, don't take no for an answer. Just keep saying, 'I think this is something serious' and don't let them discharge you, especially if it's someone who isn't familiar with pregnant women."

-- Marie McCausland

"The postpartum period is when a lot of pregnancy-related heart problems like cardiomyopathy emerge. If there is still difficulty breathing, fluid buildup in ankles, shortness of breath and you are unable to lie flat on your back, go see a cardiologist ASAP. If you have to go to an emergency room, request to have the following tests performed: echocardiogram (echo) test, ejection fraction test, B-type natriuretic peptides (BNP), EKG test and chest x-ray test. These tests will determine if your heart is failing and will save your life."

-- Anner Porter

"Rest as much as possible -- for as long as possible. Being in too big a rush to get 'back to normal' can exacerbate postpartum health risks. Things that are not normal: heavy bleeding longer than 6 weeks, or bleeding that stops and starts again, not producing milk, fevers, severe pain (especially around incision sites), excessive fatigue, and anxiety/depression. If you don't feel like yourself, get help."

-- Amy Barron Smolinski, 37, a survivor of preeclampsia, postpartum hemorrhage and other complications in three pregnancies in 2006, 2011 and 2012 and executive director of Mom2Mom Global, a breastfeeding support group

"Know that your preexisting health conditions may be impacted by having a baby (hormone changes, sleep deprivation, stress). Record your health and your baby's in a journal or app to track any changes. Reach out to the nurse or doctor when there are noticeable changes that you have tracked."

-- Noelle Garcia, 33, survived placental abruption (placenta separating from the uterine wall during pregnancy) in 2007

"If your hospital discharges you on tons of Motrin or pain killers, be aware that this can mask the warning signs of headache, which is sometimes the only warning sign of preeclampsia coming on postpartum."

-- Emily McLaughlin

Grappling With the Emotional Fallout

"I wish I had known that postpartum PTSD was possible. Most people associate PTSD with the effects of war, but I was diagnosed with PTSD after my traumatic birth and near-death experience. Almost 6 years later, I still experience symptoms sporadically."

-- Meagan Raymer, 31, survived severe preeclampsia and HELLP syndrome in 2011

"I recommend therapy with a female therapist specializing in trauma. Honestly, I avoided it for 8 months. I was then in therapy for 12 months. I still have ongoing anxiety... but I would be in a very bad place (potentially depression and self-harm due to self-blame) were it not for therapy. It was so hard to admit [what was happening]. I started to get a suspicion when I heard an NPR story about a veteran with PTSD. I thought... that sounds like me. And I started Googling."

-- Jessica Rae Hoffman, 28, survived severe sepsis and other complications in 2015

"The emotional constructs our society puts around pregnancy and childbirth make the ideas of severe injury and death taboo. Childbirth is a messy, traumatic experience. ... Many women don't seek care even when they instinctively believe something is wrong because they're supposed to 'be happy.' Awareness and transparency are so important."

-- Leah Soule, 33, survived a hemorrhage in 2015

"Having an incredible support network made the greatest impact with my near-death experience, but my family and friends needed their own support as they coped. My mom didn't leave my side, but she also had a team of friends supporting her so that she could let her guard down and cry when she needed to do so. My husband was at my bedside or with the baby constantly that first week, but he was also suffering from the trauma of everything and was having a really hard time coping and needed to leave the hospital environment. My best friend is an ICU nurse and quickly became the person everyone asked clarifying questions, but she didn't want to be a nurse in that moment but rather someone who was scared for her friend."

-- Susan Lewis

"I wish I had understood how significant the impact was on my husband. Emotionally, the experience was much more difficult and long-lasting for him than for me, and it continued to affect his relationship with both me and our baby for quite a while, at a time when I didn't think it was a thing at all."

-- Elizabeth Venstra, 44, survived HELLP syndrome in 2014

"I would suggest establishing yourself ahead of time with a doula or midwife that can make postpartum visits to your home, which can promote health even if everything goes smoothly. Many communities have those services available if you can't afford them. [A doula] wasn't covered through our insurance, but the social worker at the hospital arranged for someone paid for by [San Diego County] to come and do several checks on me and my son, which was very reassuring to both my husband and me."

-- Miranda Klassen

"If you're given a diagnosis of a life-threatening pregnancy complication, line up a therapist immediately so can start getting the support you need as soon as you give birth. Don't wait until your six-week [postpartum] appointment when they do a depression screen and you realize you're not coping well. You'll have to wait at least another week for the appointment to be made. Why not have that in place? I wish I did."

-- Megan Moody

"Don't assume everyone gets it. Don't assume everyone wants to hear it. My story is scary. Some soon-to-be moms have looked horrified by my story. Some already moms have been scared away by it. Most people are happy to listen, like to be informed. But some do not. Some people are happier thinking it's all going to be ok, not me, I'll be fine. They should at least know, but that's their choice. You can't force people to open their eyes. Be there. Offer help. But don't force it."

-- Carrie Anthony

Other Resources

  • The Leapfrog Group provides performance data on more than 1,800 hospitals and publishes an annual Maternity Care Report. Consumer Reports offers C-section data from more than 1,300 hospitals by ZIP code.
  • The California Maternal Quality Care Collaborative's "toolkits" of protocols to treat life-threatening obstetric complications include infographics, checklists and lengthy backup materials but require (free) registration for access. The Alliance for Innovation on Maternal Health's "bundles" offer similar information in a condensed, easily downloadable form.
  • The Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN)'s Health4Mom site has a "Save Your Life" campaign, including a one-page checklist, to help new mothers recognize post-birth warning signs.
  • Childbirth Connections provides evidence-based information on maternity care. The Preeclampsia Foundation's "Wonder Woman" posts (here and here) put the U.S. maternal mortality numbers in context and offer more strategies for self-advocacy.
  • Postpartum Support International offers many resources for women suffering from pregnancy-related depression, anxiety and mood disorders.
  • Facebook is a gathering place for thousands of women who've experienced life-threatening complications, but many groups are condition-specific and/or closed to non-survivors. One open group worth checking out: The Unexpected Project.
  • Social justice groups are also becoming active around the issue of maternal deaths and near-deaths, with a focus on why African-American women are disproportionately affected. They include the Black Mamas Matter Alliance and Moms Rising.

Correction, August 4, 2017: In an earlier version of this story, a quote was incorrectly attributed to Kristy Kummer-Pred. It has been deleted.

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The Myth Of Drug Expiration Dates

[Editor's Note: some politicians and pundits repeatedly claim that the private sector is more efficient than the public sector. Today's blog post explores waste in the healthcare industry. Today's post is reprinted with permission.]

By Marshall Allen, ProPublica

The box of prescription drugs had been forgotten in a back closet of a retail pharmacy for so long that some of the pills predated the 1969 moon landing. Most were 30 to 40 years past their expiration dates -- possibly toxic, probably worthless.

But to Lee Cantrell, who helps run the California Poison Control System, the cache was an opportunity to answer an enduring question about the actual shelf life of drugs: Could these drugs from the bell-bottom era still be potent?

Cantrell called Roy Gerona, a University of California, San Francisco, researcher who specializes in analyzing chemicals. Gerona had grown up in the Philippines and had seen people recover from sickness by taking expired drugs with no apparent ill effects.

"This was very cool," Gerona says. "Who gets the chance of analyzing drugs that have been in storage for more than 30 years?"

The age of the drugs might have been bizarre, but the question the researchers wanted to answer wasn't. Pharmacies across the country -- in major medical centers and in neighborhood strip malls -- routinely toss out tons of scarce and potentially valuable prescription drugs when they hit their expiration dates.

Gerona and Cantrell, a pharmacist and toxicologist, knew that the term "expiration date" was a misnomer. The dates on drug labels are simply the point up to which the Food and Drug Administration and pharmaceutical companies guarantee their effectiveness, typically at two or three years. But the dates don't necessarily mean they're ineffective immediately after they "expire" -- just that there's no incentive for drugmakers to study whether they could still be usable.

ProPublica has been researching why the U.S. health care system is the most expensive in the world. One answer, broadly, is waste -- some of it buried in practices that the medical establishment and the rest of us take for granted. We've documented how hospitals often discard pricey new supplies, how nursing homes trash valuable medications after patients pass away or move out, and how drug companies create expensive combinations of cheap drugs. Experts estimate such squandering eats up about $765 billion a year -- as much as a quarter of all the country's health care spending.

What if the system is destroying drugs that are technically "expired" but could still be safely used?

In his lab, Gerona ran tests on the decades-old drugs, including some now defunct brands such as the diet pills Obocell (once pitched to doctors with a portly figurine called "Mr. Obocell") and Bamadex. Overall, the bottles contained 14 different compounds, including antihistamines, pain relievers and stimulants. All the drugs tested were in their original sealed containers.

The findings surprised both researchers: A dozen of the 14 compounds were still as potent as they were when they were manufactured, some at almost 100 percent of their labeled concentrations.

"Lo and behold," Cantrell says, "The active ingredients are pretty darn stable."

Cantrell and Gerona knew their findings had big implications. Perhaps no area of health care has provoked as much anger in recent years as prescription drugs. The news media is rife with stories of medications priced out of reach or of shortages of crucial drugs, sometimes because producing them is no longer profitable.

Tossing such drugs when they expire is doubly hard. One pharmacist at Newton-Wellesley Hospital outside Boston says the 240-bed facility is able to return some expired drugs for credit, but had to destroy about $200,000 worth last year. A commentary in the journal Mayo Clinic Proceedings cited similar losses at the nearby Tufts Medical Center. Play that out at hospitals across the country and the tab is significant: about $800 million per year. And that doesn't include the costs of expired drugs at long-term care pharmacies, retail pharmacies and in consumer medicine cabinets.

After Cantrell and Gerona published their findings in Archives of Internal Medicine in 2012, some readers accused them of being irresponsible and advising patients that it was OK to take expired drugs. Cantrell says they weren't recommending the use of expired medication, just reviewing the arbitrary way the dates are set.  

"Refining our prescription drug dating process could save billions," he says.

But after a brief burst of attention, the response to their study faded. That raises an even bigger question: If some drugs remain effective well beyond the date on their labels, why hasn't there been a push to extend their expiration dates?

It turns out that the FDA, the agency that helps set the dates, has long known the shelf life of some drugs can be extended, sometimes by years.

In fact, the federal government has saved a fortune by doing this.

For decades, the federal government has stockpiled massive stashes of medication, antidotes and vaccines in secure locations throughout the country. The drugs are worth tens of billions of dollars and would provide a first line of defense in case of a large-scale emergency.

Maintaining these stockpiles is expensive. The drugs have to be kept secure and at the proper humidity and temperature so they don't degrade. Luckily, the country has rarely needed to tap into many of the drugs, but this means they often reach their expiration dates. Though the government requires pharmacies to throw away expired drugs, it doesn't always follow these instructions itself. Instead, for more than 30 years, it has pulled some medicines and tested their quality.

The idea that drugs expire on specified dates goes back at least a half-century, when the FDA began requiring manufacturers to add this information to the label. The time limits allow the agency to ensure medications work safely and effectively for patients. To determine a new drug's shelf life, its maker zaps it with intense heat and soaks it with moisture to see how it degrades under stress. It also checks how it breaks down over time. The drug company then proposes an expiration date to the FDA, which reviews the data to ensure it supports the date and approves it. Despite the difference in drugs' makeup, most "expire" after two or three years.

Once a drug is launched, the makers run tests to ensure it continues to be effective up to its labeled expiration date. Since they are not required to check beyond it, most don't, largely because regulations make it expensive and time-consuming for manufacturers to extend expiration dates, says Yan Wu, an analytical chemist who is part of a focus group at the American Association of Pharmaceutical Scientists that looks at the long-term stability of drugs. Most companies, she says, would rather sell new drugs and develop additional products.

Pharmacists and researchers say there is no economic "win" for drug companies to investigate further. They ring up more sales when medications are tossed as "expired" by hospitals, retail pharmacies and consumers despite retaining their safety and effectiveness.

Industry officials say patient safety is their highest priority. Olivia Shopshear, director of science and regulatory advocacy for the drug industry trade group Pharmaceutical Research and Manufacturers of America, or PhRMA, says expiration dates are chosen "based on the period of time when any given lot will maintain its identity, potency and purity, which translates into safety for the patient."

That being said, it's an open secret among medical professionals that many drugs maintain their ability to combat ailments well after their labels say they don't. One pharmacist says he sometimes takes home expired over-the-counter medicine from his pharmacy so he and his family can use it.

The federal agencies that stockpile drugs -- including the military, the Centers for Disease Control and Prevention and the Department of Veterans Affairs -- have long realized the savings in revisiting expiration dates.

In 1986, the Air Force, hoping to save on replacement costs, asked the FDA if certain drugs' expiration dates could be extended. In response, the FDA and Defense Department created the Shelf Life Extension Program.

Each year, drugs from the stockpiles are selected based on their value and pending expiration and analyzed in batches to determine whether their end dates could be safely extended. For several decades, the program has found that the actual shelf life of many drugs is well beyond the original expiration dates.

A 2006 study of 122 drugs tested by the program showed that two-thirds of the expired medications were stable every time a lot was tested. Each of them had their expiration dates extended, on average, by more than four years, according to research published in the Journal of Pharmaceutical Sciences.

Some that failed to hold their potency include the common asthma inhalant albuterol, the topical rash spray diphenhydramine, and a local anesthetic made from lidocaine and epinephrine, the study said. But neither Cantrell nor Dr. Cathleen Clancy, associate medical director of National Capital Poison Center, a nonprofit organization affiliated with the George Washington University Medical Center, had heard of anyone being harmed by any expired drugs. Cantrell says there has been no recorded instance of such harm in medical literature.

Marc Young, a pharmacist who helped run the extension program from 2006 to 2009, says it has had a "ridiculous" return on investment. Each year the federal government saved $600 million to $800 million because it did not have to replace expired medication, he says.

An official with the Department of Defense, which maintains about $13.6 billion worth of drugs in its stockpile, says that in 2016 it cost $3.1 million to run the extension program, but it saved the department from replacing $2.1 billion in expired drugs. To put the magnitude of that return on investment into everyday terms: It's like spending a dollar to save $677.

"We didn't have any idea that some of the products would be so damn stable -- so robustly stable beyond the shelf life," says Ajaz Hussain, one of the scientists who formerly helped oversee the extension program.

Hussain is now president of the National Institute for Pharmaceutical Technology and Education, an organization of 17 universities that's working to reduce the cost of pharmaceutical development. He says the high price of drugs and shortages make it time to reexamine drug expiration dates in the commercial market.

"It's a shame to throw away good drugs," Hussain says.

Some medical providers have pushed for a changed approach to drug expiration dates -- with no success. In 2000, the American Medical Association, foretelling the current prescription drug crisis, adopted a resolution urging action. The shelf life of many drugs, it wrote, seems to be "considerably longer" than their expiration dates, leading to "unnecessary waste, higher pharmaceutical costs, and possibly reduced access to necessary drugs for some patients."

Citing the federal government's extension program, the AMA sent letters to the FDA, the U.S. Pharmacopeial Convention, which sets standards for drugs, and PhRMA asking for a re-examination of expiration dates.

No one remembers the details -- just that the effort fell flat.

"Nothing happened, but we tried," says rheumatologist Roy Altman, now 80, who helped write the AMA report. "I'm glad the subject is being brought up again. I think there's considerable waste."

At Newton-Wellesley Hospital, outside Boston, pharmacist David Berkowitz yearns for something to change.

On a recent weekday, Berkowitz sorted through bins and boxes of medication in a back hallway of the hospital's pharmacy, peering at expiration dates. As the pharmacy's assistant director, he carefully manages how the facility orders and dispenses drugs to patients. Running a pharmacy is like working in a restaurant because everything is perishable, he says, "but without the free food."

Federal and state laws prohibit pharmacists from dispensing expired drugs and The Joint Commission, which accredits thousands of health care organizations, requires facilities to remove expired medication from their supply. So at Newton-Wellesley, outdated drugs are shunted to shelves in the back of the pharmacy and marked with a sign that says: "Do Not Dispense." The piles grow for weeks until they are hauled away by a third-party company that has them destroyed. And then the bins fill again.

"I question the expiration dates on most of these drugs," Berkowitz says.

One of the plastic boxes is piled with EpiPens -- devices that automatically inject epinephrine to treat severe allergic reactions. They run almost $300 each. These are from emergency kits that are rarely used, which means they often expire. Berkowitz counts them, tossing each one with a clatter into a separate container, " 'that's 45, 46, 47' " He finishes at 50. That's almost $15,000 in wasted EpiPens alone.

In May, Cantrell and Gerona published a study that examined 40 EpiPens and EpiPen Jrs., a smaller version, that had been expired for between one and 50 months. The devices had been donated by consumers, which meant they could have been stored in conditions that would cause them to break down, like a car's glove box or a steamy bathroom. The EpiPens also contain liquid medicine, which tends to be less stable than solid medications.

Testing showed 24 of the 40 expired devices contained at least 90 percent of their stated amount of epinephrine, enough to be considered as potent as when they were made. All of them contained at least 80 percent of their labeled concentration of medication. The takeaway? Even EpiPens stored in less than ideal conditions may last longer than their labels say they do, and if there's no other option, an expired EpiPen may be better than nothing, Cantrell says.

At Newton-Wellesley, Berkowitz keeps a spreadsheet of every outdated drug he throws away. The pharmacy sends what it can back for credit, but it doesn't come close to replacing what the hospital paid.

Then there's the added angst of tossing drugs that are in short supply. Berkowitz picks up a box of sodium bicarbonate, which is crucial for heart surgery and to treat certain overdoses. It's being rationed because there's so little available. He holds up a purple box of atropine, which gives patients a boost when they have low heart rates. It's also in short supply. In the federal government's stockpile, the expiration dates of both drugs have been extended, but they have to be thrown away by Berkowitz and other hospital pharmacists.

The 2006 FDA study of the extension program also said it pushed back the expiration date on lots of mannitol, a diuretic, for an average of five years. Berkowitz has to toss his out. Expired naloxone? The drug reverses narcotic overdoses in an emergency and is currently in wide use in the opioid epidemic. The FDA extended its use-by date for the stockpiled drugs, but Berkowitz has to trash it.

On rare occasions, a pharmaceutical company will extend the expiration dates of its own products because of shortages. That's what happened in June, when the FDA posted extended expiration dates from Pfizer for batches of its injectable atropine, dextrose, epinephrine and sodium bicarbonate. The agency notice included the lot numbers of the batches being extended and added six months to a year to their expiration dates.

The news sent Berkowitz running to his expired drugs to see if any could be put back into his supply. His team rescued four boxes of the syringes from destruction, including 75 atropine, 15 dextrose, 164 epinephrine and 22 sodium bicarbonate. Total value: $7,500. In a blink, "expired" drugs that were in the trash heap were put back into the pharmacy supply.

Berkowitz says he appreciated Pfizer's action, but feels it should be standard to make sure drugs that are still effective aren't thrown away.

"The question is: Should the FDA be doing more stability testing?" Berkowitz says. "Could they come up with a safe and systematic way to cut down on the drugs being wasted in hospitals?"

Four scientists who worked on the FDA extension program told ProPublica something like that could work for drugs stored in hospital pharmacies, where conditions are carefully controlled.

Greg Burel, director of the CDC's stockpile, says he worries that if drugmakers were forced to extend their expiration dates it could backfire, making it unprofitable to produce certain drugs and thereby reducing access or increasing prices.

The 2015 commentary in Mayo Clinic Proceedings, called "Extending Shelf Life Just Makes Sense," also suggested that drugmakers could be required to set a preliminary expiration date and then update it after long-term testing. An independent organization could also do testing similar to that done by the FDA extension program, or data from the extension program could be applied to properly stored medications.

ProPublica asked the FDA whether it could expand its extension program, or something like it, to hospital pharmacies, where drugs are stored in stable conditions similar to the national stockpile.

"The Agency does not have a position on the concept you have proposed," an official wrote back in an email.

Whatever the solution, the drug industry will need to be spurred in order to change, says Hussain, the former FDA scientist. "The FDA will have to take the lead for a solution to emerge," he says. "We are throwing away products that are certainly stable, and we need to do something about it."

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How Two Common Medications Became One $455 Million Specialty Pill

[Editor's Note: today's guest post, by the reporters at ProPublica, explores reasons for the high cost of prescription drugs for patients in the United States. Today's post is reprinted with permission.]

by Marshall Allen, ProPublica

Everything happened so fast as I walked out of the doctor's exam room. I was tucking in my shirt and wondering if I'd asked all my questions about my injured shoulder when one of the doctor's assistants handed me two small boxes of pills.

"These will hold you over until your prescription arrives in the mail," she said, pointing to the drug samples.

Strange, I thought to myself, the doctor didn't mention giving me any drugs.

I must have looked puzzled because she tried to reassure me.

"Don't worry," she said. "It won't cost you any more than $10."

I was glad whatever was coming wouldn't break my budget, but I didn't understand why I needed the drugs in the first place. And why wasn't I picking them up at my local CVS?

At first I shrugged it off. This had been my first visit with an orthopedic specialist and he, Dr. Mohnish Ramani, hadn't been the chatty type. He'd barely said a word as he examined me, tugging my arm this way and bending it that way before rotating it behind my back. The pain made me squirm and yelp, but he knew what he was doing. He promptly diagnosed me with frozen shoulder, a debilitating inflammation of the shoulder capsule.

But back to the drugs. As an investigative reporter who has covered health care for more than a decade, the interaction was just the sort of thing to pique my interest. One thing I've learned is that almost nothing in medicine 2014 especially brand-name drugs 2014 is ever really a deal. When I got home, I looked up the drug: Vimovo.

The drug has been controversial, to say the least. Vimovo was created using two readily and cheaply available generic, or over-the-counter, medicines: naproxen, also known by the brand Aleve, and esomeprazole magnesium, also known as Nexium. The Aleve handles your pain and the Nexium helps with the upset stomach that's sometimes caused by the pain reliever. The key selling point of this new "convenience drug"? It's easier to take one pill than two.

But only a minority of patients get an upset stomach, and there was no indication I'd be one of them. Did I even need the Nexium component?

Of course I also did the math. You can walk into your local drugstore and buy a month's supply of Aleve and Nexium for about $40. For Vimovo, the pharmacy billed my insurance company $3,252. This doesn't mean the drug company ultimately gets paid that much. The pharmaceutical world is rife with rebates and side deals 2014 all designed to elbow ahead of the competition. But apparently the price of convenience comes at a steep mark-up.

Think about it another way. Let's say you want to eat a peanut butter and jelly sandwich every day for a month. You could buy a big jar of peanut butter and a jar of grape jelly for less than 10 bucks. Or you could buy some of that stuff where they combine the peanut butter and grape jelly into the same jar. Smucker's makes it. It's called Goober. Except in this scenario, instead of its usual $3.50 price tag, Smucker's is charging $565 for the jar of Goober.

So if Vimovo is the Goober of drugs, then why have Americans been spending so much on it? My insurance company, smartly, rejected the pharmacy's claim. But I knew Vimovo's makers weren't wooing doctors like mine for nothing. So I looked up the annual reports for the Ireland-based company, Horizon Pharma, which makes Vimovo. Since 2014, Vimovo's net sales have been more than $455 million. That means a lot of insurers are paying way more than they should for their Goober.

And Vimovo wasn't Horizon's only such drug. It has brought in an additional $465 million in net sales from Duexis, a similar convenience drug that combines ibuprofen and famotidine, AKA Advil and Pepsid.

This year I have been documenting the kind of waste in the health care system that's not typically tracked. Americans pay more for health care than anyone else in the world, and experts estimate that the U.S. system wastes hundreds of billions of dollars a year. In recent months I've looked at what hospitals throw away and how nursing homes flush or toss out hundreds of millions of dollars' worth of usable medicine every year. We all pay for this waste, through lower wages and higher premiums, deductibles and out-of-pocket costs. There doesn't seem to be an end in sight 2014 I just got a notice that my premiums may be increasing by another 12 percent next year.

With Vimovo, it seemed I stumbled on another waste stream: overpriced drugs whose actual costs are hidden from doctors and patients. In the case of Horizon, the brazenness of its approach was even more astounding because it had previously been called out in media reports and in a 2016 congressional hearing on out-of-control drug prices.

Health care economists also were wise to it.

"It's a scam," said Devon Herrick, a health care economist with the National Center for Policy Analysis. "It is just a way to gouge insurance companies or employer health care plans."

Unsurprisingly, Horizon says the high price is justified. In fact, the drug maker wrote in an email, "The price of Vimovo is based on the value it brings to patients."

Thousands of patients die and suffer injuries every year, the company said, because of gastric complications from naproxen and other non-steroid anti-inflammatory drugs (NSAIDs). Providing pain relief and stomach protection in a single pill makes it more likely patients will be protected from complications, it said.

And Horizon stressed Vimovo is a "special formulation" of Aleve and Nexium, so it's not the same as taking the two separately. But several experts said that's a scientific distinction that doesn't make a therapeutic difference. "I would take the two medications from the drugstore in a heartbeat 2014 therapeutically it makes sense," said Michael Fossler, a pharmacist and clinical pharmacologist who is chair of the public-policy committee for the American College of Clinical Pharmacology. "What you're paying for with [Vimovo] is the convenience. But it does seem awful pricey for that."

Public outrage is boiling over when it comes to high drug prices, leading the media and lawmakers to scold pharmaceutical companies. You'd think a regulator would monitor this, but the Food and Drug Administration told me they are only authorized to review new drugs for safety and effectiveness, not prices. "Prices are set by manufacturers and distributors," the FDA said in a statement.

Horizon acquired Vimovo in November 2013 from the global pharmaceutical giant AstraZeneca. Horizon knew it faced challenges trying to get top dollar for inexpensive ingredients. "Use of these therapies separately in generic form may be cheaper," it said in its 2013 report to investors. But the company executed a shrewd strategy to give everyone -- insurers, patients, doctors and pharmacies -- the incentive to use Vimovo. It's instructive to review its playbook.

To get Vimovo covered, Horizon made deals with insurance payers and pharmacy benefit managers -- the intermediaries who help determine which drugs get reimbursed. The contracts generally included special rebates and even administrative fees for these intermediaries, the Horizon reports said, so the drug maker got paid much less than the sticker price, though it wouldn't say how much. But the company's net sales show the deals worked.

Horizon put boots on the ground to get the prescriptions rolling, expanding its sales force by the hundreds and focusing its marketing and sales efforts on doctors who already liked to prescribe brand-name drugs. The company's message to doctors emphasized the convenience of prescribing the two ingredients in a single pill and that the single pill protected patients by making it more likely they would take their medication as directed.

Horizon also primed the medical community by giving donations totaling $101,000 to the American Gastroenterology Association, a specialty nonprofit for physicians. Some doctors refuse drug-industry money, if only to at least avoid the appearance of a conflict of interest. ProPublica has done loads of stories showing why doctors taking money is indeed problematic, including one about drug makers' influence on physician specialty groups. When I went on the American Gastroenterology Association's website, the first thing I saw was a pop-up ad from a drug company. Several of the association's board members have received drug-company money, too. Horizon has made clear in its annual reports that donations to the group "help physicians and patients better understand and manage" the risks of pain relievers causing gastric problems.

Horizon also zeroed in on patients' worries about drug costs. To encourage them to fill their prescriptions, Horizon covered all or most of their out-of-pocket costs. That's why my doctor's office could promise me I wouldn't spend too much for my Vimovo. The program, Horizon told investors in reports, addressed the impact of pharmacies switching to less expensive alternatives and could "mitigate" the effect of payers searching for cheaper alternatives.

The strategy worked on me. I didn't even know why I was getting the prescription, but when they told me it wouldn't cost more than I would spend on lunch with a friend, I gave it the OK. A pharmacy I'd never heard of sent me a bottle of Vimovo for $10, even though my insurance company rejected the claim.

Turns out paying the patient's costs motivated my doctor, too. I waited until the end of my next visit to bring up Vimovo, and then we had a follow-up conversation on the phone. Ramani didn't know the price of the drug and found it "disturbing" when I told him. That was a surprise to me, but not to him. He said he leaves billing to his staff and doesn't even know how much he gets paid for a lot of the procedures he performs, let alone how much insurers are being charged for drugs. The marketing arms of companies like Horizon must count on this sort of blindness.

Ramani doesn't receive money or gifts from Horizon. (I confirmed this on ProPublica's Dollars for Docs website, which lists drug-company payments.) He said he likes Vimovo because Horizon covers the patient's out-of-pocket costs, entirely in many cases. Prescribing the generics or over-the-counter medications separately would actually cost more, he said. Which of course is exactly the company's plan. But Ramani agreed that the high cost of the drug to insurers ultimately raises overall health care costs for all Americans.

Knowing Vimovo's price, I asked him if he would continue to prescribe it. "It changes my thought process," he said. "But at the end of the day, I have to think about the patient and whether the patient will be able to pay out of pocket or not."

Ramani said the Horizon drug rep told him Vimovo prescriptions had to go through a particular pharmacy for the patient to receive financial assistance. In its 2016 annual report, Horizon wrote that prescriptions for its drugs might not be filled by certain pharmacies because of insurance-company exclusions, co-payment requirements, or incentives to use lower-priced alternatives. So that's why they didn't give me the option of picking up my pills at my neighborhood drugstore.

Instead, my Vimovo was mailed to me from White Oak Pharmacy in Nutley, New Jersey, which is about 45 minutes from my house. I drove there to find out why. The neighborhood pharmacy is on the bottom floor of a two-story brick building on a street corner, next to a hair salon.

Vishal Chhabria, the pharmacist who owns White Oak, told me the drug company sets the price of Vimovo. He insisted his pharmacy has no special relationship or contract with Horizon. Maybe the drug company steers prescriptions his way, he said, because his pharmacy will process the coupons that reduce or eliminate the patient costs, which some pharmacies don't.

Chhabria said there is no approved generic alternative to Vimovo, so he can't suggest one to patients. And while other drugs, like over-the-counter medications, would be cheaper for the health system overall, they are more expensive for the individual patient, he said.

In poring through Horizon's financial filings, it appears the drug's run may be ending. Horizon said in its report for the first quarter of 2017 that fewer insurance companies have been willing to cover Vimovo and many that do have demanded larger rebates. As a result, Horizon has been eating more of the costs of providing the drug to patients, as they must have in my case. The prescriptions have still been coming in, but net sales were just under $5 million in the first quarter of this year, down 81 percent from the first quarter of 2016.

Critics of Vimovo say that's still more than patients should be spending on the drug. "That number should be zero," said Linda Cahn, an attorney who advises corporations, unions and other payers to help reduce their costs. "If you want to talk about waste, that's waste."

Herrick, the health care economist, said Horizon cashed in by eliminating many of the barriers in the system that are meant to control costs. The company got patients on board by covering their out-of-pocket costs. It appealed to doctors by promoting the benefits to patients. And it did an end-run around chain pharmacies, which typically might suggest a lower-priced alternative, by steering prescriptions to pharmacists who would participate in their patient-assistance program.

"Somebody brainstormed: 'How can we nullify any consumer check and balance in this supply chain? What can we do to keep the customer from asking questions?'" Herrick said.

The scheme that played out with Vimovo is bound to happen again, Herrick said. Maybe it already is. Drug companies are always on the lookout to deploy similar strategies.

I dutifully took my Vimovo for several days, until I noticed it kept me awake until 3 in the morning 2014 a rare side effect. (Perhaps they need to add a third drug to the combo.) I probably have more than 50 pills left in the bottle on my bedside table. Maybe I could sell it back to Horizon for $1,500.

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3 Strategies To Defend GOP Health Bill: Euphemisms, False Statements and Deleted Comments

[Editor's Note: today's guest post is by the reporters as ProPublica. Affordable health care and coverage are important to many, if not most, Americans. It is reprinted with permission.]

by Charles Ornstein, ProPublica

Earlier this month, a day after the House of Representatives passed a bill to repeal and replace major parts of the Affordable Care Act, Ashleigh Morley visited her congressman's Facebook page to voice her dismay.

"Your vote yesterday was unthinkably irresponsible and does not begin to account for the thousands of constituents in your district who rely upon many of the services and provisions provided for them by the ACA," Morley wrote on the page affiliated with the campaign of Representative Peter King (Republican, New York). "You never had my vote and this confirms why."

The next day, Morley said, her comment was deleted and she was blocked from commenting on or reacting to King's posts. The same thing has happened to others critical of King's positions on health care and other matters. King has deleted negative feedback and blocked critics from his Facebook page, several of his constituents say, sharing screenshots of comments that are no longer there.

"Having my voice and opinions shut down by the person who represents me -- especially when my voice and opinion wasn't vulgar and obscene -- is frustrating, it's disheartening, and I think it points to perhaps a larger problem with our representatives and maybe their priorities," Morley said in an interview.

King's office did not respond to requests for comment.

As Republican members of Congress seek to roll back the Affordable Care Act, commonly called Obamacare, and replace it with the American Health Care Act, they have adopted various strategies to influence and cope with public opinion, which polls show mostly opposes their plan. ProPublica, with our partners at Kaiser Health News, Stat and Vox, has been fact-checking members of Congress in this debate and we've found misstatements on both sides, though more by Republicans than Democrats. The Washington Post's Fact Checker has similarly found misstatements by both sides.

Today, we're back with more examples of how legislators are interacting with constituents about repealing Obamacare, whether online or in traditional correspondence. Their more controversial tactics seem to fall into three main categories: providing incorrect information, using euphemisms for the impact of their actions, and deleting comments critical of them. (Share your correspondence with members of Congress with us.)

Incorrect Information

Representative Vicky Hartzler (Republican, Missouri) sent a note to constituents this month explaining her vote in favor of the Republican bill. First, she outlined why she believes the ACA is not sustainable -- namely, higher premiums and few choices. Then she said it was important to have a smooth transition from one system to another.

"This is why I supported the AHCA to follow through on our promise to have an immediate replacement ready to go should the ACA be repealed," she wrote. "The AHCA keeps the ACA for the next three years then phases in a new approach to give people, states, and insurance markets plenty of time to make adjustments."

Except that's not true.

"There are quite a number of changes in the AHCA that take effect within the next three years," wrote ACA expert Timothy Jost, an emeritus professor at Washington and Lee University School of Law, in an email to ProPublica.

The current law's penalties on individuals who do not purchase insurance and on employers who do not offer it would be repealed retroactively to 2016, which could remove the incentive for some employers to offer coverage to their workers. Moreover, beginning in 2018, older people could be charged premiums up to five times more than younger people -- up from three times under current law. The way in which premium tax credits would be calculated would change as well, benefiting younger people at the expense of older ones, Jost said.

"It is certainly not correct to say that everything stays the same for the next three years," he wrote.

In an email, Hartzler spokesman Casey Harper replied, "I can see how this sentence in the letter could be misconstrued. It's very important to the Congresswoman that we give clear, accurate information to her constituents. Thanks for pointing that out."

Other lawmakers have similarly shared incorrect information after voting to repeal the ACA. Representative Diane Black (Republican, Tennessee) wrote in a May 19 email to a constituent that "in 16 of our counties, there are no plans available at all. This system is crumbling before our eyes and we cannot wait another year to act."

Black was referring to the possibility that, in 16 Tennessee counties around Knoxville, there might not have been any insurance options in the ACA marketplace next year. However, 10 days earlier, before she sent her email, BlueCross BlueShield of Tennessee announced that it was willing to provide coverage in those counties and would work with the state Department of Commerce and Insurance "to set the right conditions that would allow our return."

"We stand by our statement of the facts, and Congressman Black is working hard to repeal and replace Obamacare with a system that actually works for Tennessee families and individuals," her deputy chief of staff Dean Thompson said in an email.

On the Democratic side, the Washington Post Fact Checker has called out representatives for saying the AHCA would consider rape or sexual assault as pre-existing conditions. The bill would not do that, although critics counter that any resulting mental health issues or sexually transmitted diseases could be considered existing illnesses.

Euphemisms

A number of lawmakers have posted information taken from talking points put out by the House Republican Conference that try to frame the changes in the Republican bill as kinder and gentler than most experts expect them to be.

An answer to one frequently asked question pushes back against criticism that the Republican bill would gut Medicaid, the federal-state health insurance program for the poor, and appears on the websites of Representative Garret Graves (Republican, Louisiana) and others.

"Our plan responsibly unwinds Obamacare's Medicaid expansion," the answer says. "We freeze enrollment and allow natural turnover in the Medicaid program as beneficiaries see their life circumstances change. This strategy is both fiscally responsible and fair, ensuring we don't pull the rug out on anyone while also ending the Obamacare expansion that unfairly prioritizes able-bodied working adults over the most vulnerable."

That is highly misleading, experts say.

The Affordable Care Act allowed states to expand Medicaid eligibility to anyone who earned less than 138 percent of the federal poverty level, with the federal government picking up almost the entire tab. Thirty-one states and the District of Columbia opted to do so. As a result, the program now covers more than 74 million beneficiaries, nearly 17 million more than it did at the end of 2013.

The GOP health care bill would pare that back. Beginning in 2020, it would reduce the share the federal government pays for new enrollees in the Medicaid expansion to the rate it pays for other enrollees in the state, which is considerably less. Also in 2020, the legislation would cap the spending growth rate per Medicaid beneficiary. As a result, a Congressional Budget Office review released Wednesday estimates that millions of Americans would become uninsured.

Sara Rosenbaum, a professor of health law and policy at the Milken Institute School of Public Health at George Washington University, said the GOP's characterization of its Medicaid plan is wrong on many levels. People naturally cycle on and off Medicaid, she said, often because of temporary events, not changing life circumstances -- seasonal workers, for instance, may see their wages rise in summer months before falling back.

"A terrible blow to millions of poor people is recast as an easing off of benefits that really aren't all that important, in a humane way," she said.

Moreover, the GOP bill actually would speed up the "natural turnover" in the Medicaid program, said Diane Rowland, executive vice president of the Kaiser Family Foundation, a health care think tank. Under the ACA, states were only permitted to recheck enrollees' eligibility for Medicaid once a year because cumbersome paperwork requirements have been shown to cause people to lose their coverage. The American Health Care Act would require these checks every six months -- and even give states more money to conduct them.

Rowland also took issue with the GOP talking point that the expansion "unfairly prioritizes able-bodied working adults over the most vulnerable." At a House Energy and Commerce Committee hearing earlier this year, GOP representatives maintained that the Medicaid expansion may be creating longer waits for home- and community-based programs for sick and disabled Medicaid patients needing long-term care, "putting care for some of the most vulnerable Americans at risk."

Research from the Kaiser Family Foundation, however, showed that there was no relationship between waiting lists and states that expanded Medicaid. Such waiting lists pre-dated the expansion and they were worse in states that did not expand Medicaid than in states that did.

"This is a complete misrepresentation of the facts," Rosenbaum said.

Graves' office said the information on his site came from the House Republican Conference. Emails to the conference's press office were not returned.

The GOP talking points also play up a new Patient and State Stability Fund included in the AHCA, which is intended to defray the costs of covering people with expensive health conditions. "All told, $130 billion dollars would be made available to states to finance innovative programs to address their unique patient populations," the information says. "This new stability fund ensures these programs have the necessary funding to protect patients while also giving states the ability to design insurance markets that will lower costs and increase choice."

The fund was modeled after a program in Maine, called an invisible high-risk pool, which advocates say has kept premiums in check in the state. But Senator Susan Collins (Republican, Maine) says the House bill's stability fund wasn't allocated enough money to keep premiums stable.

"In order to do the Maine model 2014 which I've heard many House people say that is what they're aiming for -- it would take $15 billion in the first year and that is not in the House bill," Collins told Politico. "There is actually $3 billion specifically designated for high-risk pools in the first year."

Deleting Comments

Morley, 28, a branded content editor who lives in Seaford, New York, said she moved into Representative King's Long Island district shortly before the 2016 election. She said she did not vote for him and, like many others across the country, said the election results galvanized her into becoming more politically active.

Earlier this year, Morley found an online conversation among King's constituents who said their critical comments were being deleted from his Facebook page. Because she doesn't agree with King's stances, she said she wanted to reserve her comment for an issue she felt strongly about.

A day after the House voted to repeal the ACA, Morley posted her thoughts. "I kind of felt that that was when I wanted to use my one comment, my one strike as it would be," she said.

By noon the next day, it had been deleted and she had been blocked.

"I even wrote in my comment that you can block me but I'm still going to call your office," Morley said in an interview.

Some negative comments about King remain on his Facebook page. But King's critics say his deletions fit a broader pattern. He has declined to hold an in-person town hall meeting this year, saying, "to me all they do is just turn into a screaming session," according to CNN. He held a telephonic town hall meeting but only answered a small fraction of the questions submitted. And he met with Liuba Grechen Shirley, the founder of a local Democratic group in his district, but only after her group held a protest in front of his office that drew around 400 people.

"He's not losing his health care," Grechen Shirley said. "It doesn't affect him. It's a death sentence for many and he doesn't even care enough to meet with his constituents."

King's deleted comments even caught the eye of Andy Slavitt, who until January was the acting administrator of the Centers for Medicare and Medicaid Services. Slavitt has been traveling the country pushing back against attempts to gut the ACA.

.@RepPeteKing, are you silencing your constituents who send you questions? Assume ppl in district will respond if this is happening.

-- Andy Slavitt (@ASlavitt) May 12, 2017

Since the election, other activists across the country who oppose the president's agenda have posted online that they have been blocked from following their elected officials on Twitter or commenting on their Facebook pages because of critical statements they've made about the AHCA and other issues.

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America's Other Drug Problem

[Editor's Note: today's guest blog post, by reporters at ProPublica, explores the waste problem in the health care industry, and the accompanying pollution. It is reprinted with permission.]

by Marshall Allen, ProPublica

Every week in Des Moines, Iowa, the employees of a small nonprofit collect bins of unexpired prescription drugs tossed out by nursing homes after residents died, moved out or no longer needed them. The drugs are given to patients who couldn't otherwise afford them.

But travel 1,000 miles east to Long Island, New York, and you'll find nursing homes flushing similar leftover drugs down the toilet, alarming state environmental regulators worried they'll further contaminate the water supply.

In Baltimore, Maryland, a massive incinerator burns up tons of the drugs each year -- for a fee -- from nursing homes across the Eastern seaboard.

If you want to know why the nation's health care costs are among the highest in the world, a good place to start is with what we throw away. Across the country, nursing homes routinely toss large quantities of perfectly good prescription medication: tablets for diabetes, syringes of blood thinners, pricey pills for psychosis and seizures.

At a time when anger over soaring drug costs has perhaps never been more intense, redistributing discarded drugs seems like a no-brainer. Yet it's estimated that American taxpayers, through Medicare, spend hundreds of millions of dollars each year on drugs for nursing home patients -- much of which literally go down the tubes.

"It would not surprise me if as much as 20 percent of the medications we receive we end up having to destroy," said Mark Coggins, who oversees the pharmacy services for Diversicare, a chain of more than 70 nursing homes in 10 states. "It's very discouraging throwing away all those drugs when you know it can benefit somebody."

No one tracks this waste nationwide, but estimates show it's substantial. Colorado officials have said the state's 220 long-term care facilities throw away a whopping 17.5 tons of potentially reusable drugs every year, with a price tag of about $10 million. The Environmental Protection Agency estimated in 2015 that about 740 tons of drugs are wasted by nursing homes each year.

This is, of course, part of a bigger problem. The National Academy of Medicine estimated in 2012 that the United States squanders more than a quarter of what it spends on health care 2014 about $765 billion a year.

ProPublica is investigating the types of waste in health care that academics and politicians typically overlook. Our first installment examined the tens of millions worth of equipment and brand new supplies that hospitals jettison.

Today we look at the wasteful, and potentially harmful, ways nursing homes dispose of leftover meds -- and how some states, like Iowa, have found a solution.

On a recent Wednesday in Des Moines, Ami Bradwell, a certified pharmacy technician, popped open the lids of several 31-gallon bins full of prescription drugs. In each were hundreds of what are known as "bingo cards" filled with rows of pills in sealed bubbles.

"Metformin -- for diabetics," Bradwell said, holding up a card of large white pills. "It's not crazy expensive, but it's in high demand."

She held up an entire box of the anti-nausea drug Ondansetron. It goes for about $5 a pill, according to the website drugs.com. "Expensive."

Another card had three large pills stuffed in each chamber, a find Bradwell called "a 'jackpot' card. You can't live without it because it's a seizure medication."

Image from SafeNetRx Drug Donation Repository Bradwell works for the nonprofit SafeNetRx. Each week the group takes in dozens of bins full of such drugs, as well as boxes mailed in from across Iowa and several other states -- pharmaceutical trash that exists because, for convenience and cost, long-term care pharmacies often dispense nursing home patients' medications in bulk, a month's worth at a time.

Should a patient die, leave or stop taking the drug, what's left is typically tossed. The drugs have already been paid for, by Medicare in most cases, so there's little incentive to try to recycle them. In some states, such reuse is against the law.

Some of the cards Bradwell examined that day were missing only a few pills. One card had been thrown out even though it only lacked one of its 31 doses of oxybutynin, which reduces muscle spasms of the bladder. The remaining 30 are worth more than $13.

"There are literally millions of dollars of prescription medications thrown away every day in this country," said John Forbes, an Iowa pharmacist who dispenses SafeNetRx's recovered drugs to his low-income patients.

Although most states technically allow some leftover drugs to be recycled, Iowa is one of the few rescuing a significant percentage of the drugs from destruction. The state funds the program for about $600,000 a year, said SafeNetRx CEO Jon Rosmann, who calls it a "common sense" solution. In fiscal 2016 the program recovered and distributed drugs valued at about $3.4 million. This year it's on pace to top $5 million.

Forbes, who is also an Iowa state representative, said there are additional savings when low-income patients have access to the drugs they need. Patients who don't take their drugs "end up in the emergency room," he said, "which will wind up costing our health care system way more money."

At SafeNetRx, the drugs are sorted and organized in a 1,500-square-foot room lined with shelves stacked with bins of drugs. In the center, folding tables hold hundreds of bingo cards, sorted alphabetically by generic drug name, from the blood pressure drug acebutolol to the antipsychotic ziprasidone. None of the medications are controlled substances, though those may be included in the future.

Pharmacy officials say there may be a million dollars' worth of drugs in this small room. The 30 mg syringes of the blood thinner Enoxaparin are used by patients for weeks before and after heart surgery. They can go for $13 per dose.

One box contains scores of doses of Spiriva, inhalation capsules for chronic obstructive pulmonary disease that would sell for about $18 each. The antipsychotic Abilify runs about $46 per pill.

The biggest ticket items are the cancer drugs. They are typically donated directly from patients or their families. Those can run $8,000 or more per month.

The cancer drugs are passed on to people like Amber Judge, a patient advocate at Medical Oncology and Hematology Associates, a cancer clinic in Des Moines. Judge is accustomed to patients coming into her office in a panic. They've just learned they have cancer, only to find out they can't afford the drugs they need to battle the disease. That's when Judge opens one of the file drawers in her office, which are filled with tens of thousands of dollars' worth of the drugs recovered by SafeNetRx.

In one filing drawer she has about 30 boxes of Tasigna, which costs about $100 per pill. In another drawer she has a gallon-sized plastic bag with bottles of Stivarga, about $188 per pill.

The process is similar to patients receiving drug samples at a doctor's office. They leave her office with the drugs they need -- for free.

"I give them a month's supply if I have it," Judge said. "They're so thankful. They're incredulous."

In many places in the United States, however, these leftover drugs meet a very different end, one that is not only wasteful, but potentially harmful.

In recent years, scientists have detected something disturbing in the Long Island's aquifer: low levels of pharmaceuticals.

Though consumers have been warned not to flush their drugs down the toilet because sewer waste can contaminate groundwater, many still do it; more worrisome still, flushing remains a common practice at nursing homes in New York and across the country. The effects of such contamination on humans are unclear, but it has been shown to slow the metamorphosis of frogs and increase the feminization of fish.

Three years ago, New York's Department of Environmental Conservation started an annual program, funded by the state legislature, to scoop up unused medications before they were flushed. Even though the pickup service is free to facilities, only two dozen of 169 eligible Long Island nursing homes participated this February, turning over 660 pounds of drugs.

Those valuable medications didn't go into the water supply, but they didn't go to needy patients, either, though such recycling is now allowed in New York. Instead, they went to an incinerator company. Experts, including the EPA, have recommended incineration for getting rid of pharmaceuticals.

Destroying the unused drugs is always going to have environmental implications, said Carrie Meek Gallagher, region 1 director for the department. "It's always a trade-off of what's most harmful. For us, anything getting into the water is the worst solution."

The National Conference of State Legislatures said 39 states had passed laws that allowed the donation of drugs. But almost half of these states with laws lack programs to get the drugs safely from one appropriate user to another, and many of those that do have programs are focused on cancer drugs, the analysis showed.

There hasn't been a lot of public opposition to redistributing the drugs, even among drugmakers. Most concerns circle around logistics, although in Illinois trial attorneys have lobbied against a proposed program, saying it muddies liability issues.

Richard Cauchi, program director for health for the conference of state legislatures, said just passing laws doesn't guarantee success. A state agency or organization needs to oversee the program, encouraging participation and streamlining its administration so it's not a burden for pharmacies and nursing homes.

"It's a lot of work, and from a retail point of view, an expense," Cauchi said. "How do you accept these drugs? How do you confirm their safety? How do you know they meet the proper standards?"

Federal agencies are of little help, each pursuing their own, often contradictory, agendas.

The EPA discourages flushing drugs because they contaminate the water supply. But it doesn't have the authority to prohibit "sewering" the medications. Only local authorities can take that stance. It has, however, proposed reclassifying the unused drugs as hazardous waste, which would then prohibit flushing them.

The Food and Drug Administration says certain medications are so dangerous that they should be disposed of immediately, even if that means flushing them. It even provides a list of drugs recommended for flushing, mostly controlled substances like diazepam, better known as Valium, and the potent painkiller fentanyl.

The Drug Enforcement Administration wants to ensure controlled substances, like narcotic painkillers, aren't diverted to the illegal drug market. It has recommended that long-term pharmacies collect leftover drugs by placing boxes in nursing homes that must be emptied at least every three days, but that creates expense, hassle and potential liability.

Some advocates say the makers of the drugs should be responsible for disposing or recycling them. Scott Cassel, CEO of the Product Stewardship Institute, a nonprofit organization dedicated to reducing the environmental impact of consumer products, said the producers of batteries, electronics, paint and other products are required by law in some areas to pay for the safe disposal of their products. Similar laws require drug makers to pay for the destruction of leftover household drugs in two states and about a dozen counties, but no laws address nursing homes.

Coggins, who leads the pharmacy services for the Diversicare chain, said people in the nursing home industry would like to do something about the waste. But their options are dictated by laws and regulations, and there's been a lack of investment in cost-effective solutions like the one in Iowa.

About half the states where Diversicare operates allow the donation of unused drugs, but the programs required too much work sorting and inventorying the drugs without any reimbursement, he said. "It's like people have created legislation and it's a feel-good thing, but nobody's come back to see why it's not working."

Diversicare avoids flushing drugs whenever possible, Coggins said, but it still occurs sometimes. The organization has switched to a product called Rx Destroyer that chemically deactivates the medication so it can be put in the trash, he said, but even that is controversial because it goes into a landfill.

In many nursing homes, flushing is just part of the routine.

"Oh my goodness, it's so sad," said Jennifer Ramsey, a nurse who formerly worked as a house supervisor for a nursing home in South Haven, Mississippi. Once a month she and another nurse would gather all the unused blister packs of medication, she said, piles of them, probably worth tens of thousands of dollars. Then they would pop the pills one by one into the toilet.

"You would spend almost your whole eight-hour day doing it," Ramsey recalled.

Ramsey now works for the nonprofit Good Shepherd Pharmacy in Memphis. In Tennessee, the law requires nursing homes to destroy unused drugs on site. Good Shepherd's founder is pressing to change the law so the drugs can be saved and donated.

In March, state Rep. Cameron Sexton, a Republican whose wife is a pharmacist, introduced a bill that would allow unexpired medications to be donated in Tennessee. "Unfortunately, we don't have a process set up to do that so all these drugs have to be destroyed," he said.

Perhaps the most graphic way to see the waste firsthand is a visit to the Curtis Bay Medical Waste facility on the south side of Baltimore, home of the largest incinerator of its kind in the country.

Here Curtis Bay's fleet of trucks delivers load after load of unused, unexpired drugs from hundreds of nursing homes and other facilities and clinics up and down the East Coast. Drugs also come from medical waste companies like SteriCycle and Daniels Sharpsmart. In 2015, 204 tons of non-hazardous pharmaceutical waste came from the Daniels location in the Bronx, according to records filed in New York. Such waste includes not only drugs tossed by nursing homes, but also those from hospitals, doctors' offices and other facilities.

Inside Curtis Bay, the drugs are processed and destroyed in an area the size of several hockey rinks. A conveyor belt about 15 feet off the ground snakes through the facility loaded with hundreds of boxes of pharmaceutical and medical waste 2014 all leading to the two incineration chambers.

On a recent visit, the chamber was over 2,000 degrees, a heat that could be felt from 20 feet away.

From a platform above the incinerator's maw, you can watch as thousands of dollars of potentially lifesaving pills and medications tumble, box by box, into the steaming opening. Then they are shoveled into the blaze.

Experts say incineration is the least environmentally objectionable end-of-life option for unused drugs. But it's also the most expensive destruction method -- from 50 cents to a dollar per pound, paid for by the facilities themselves -- which is why many nursing homes resort to flushing.

Nursing homes save the disposal fees in Iowa, because they can donate them to SafeNetRx, where they benefit needy patients like Max Armstrong.

The 82-year-old suffers from multiple chronic conditions -- emphysema, congestive heart failure and more. The ailments were manageable until 2015, when he suffered blood clots in his leg and lung. Doctors put him on the generic blood thinner warfarin, but it "almost killed me," he said, so he switched to Xarelto, a newer brand name drug that costs about $700 a month.

The total tab for the Xarelto and the other 14 medications Armstrong must take each month would cost at least $1,200, according to his daughter. Armstrong, whose savings took a hit during the financial crisis, lives on $1,158 a month in Social Security.

It's "stupid" to throw away drugs that can keep so many other people healthy, Armstrong said. "There's a lot of people out there in this world who need help."

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