Will Your Prescription Meds Be Covered Next Year? Better Check!

Express Scripts assures patients it has a policy of not putting cancer medicine or mental health drugs on the list of products it excludes from its formulary.

Express Scripts assures patients it has a policy of not putting cancer medicine or mental health drugs on the list of products it excludes from its formulary. Fuse/Getty Images hide caption

toggle caption Fuse/Getty Images

The battle continues to rage between drug companies that are trying to make as much money as possible and insurers trying to drive down drug prices. And consumers are squarely in the middle.

That’s because, increasingly, prescription insurers are threatening to kick drugs off their lists of approved medications if the manufacturers won’t give them big discounts.

CVS Caremark and Express Scripts, the biggest prescription insurers, released their 2017 lists of approved drugs this month, and each also has long lists of excluded medications. Some of the drugs newly excluded are prescribed to treat diabetes and hepatitis. The CVS list also excludes some cancer drugs, along with Proventil and Ventolin, commonly prescribed brands of asthma inhalers, while Express Scripts has dropped Orencia, a drug for rheumatoid arthritis.

Such exclusions can take customers by surprise, says Lisa Gill, an editor at Consumer Reports‘ “Best Buy Drugs.”

“We’ve talked to dozens and dozens of people who find themselves at the pharmacy counter, shocked to find out that the drug is no longer covered,” she tells Shots. Patients can appeal the decision in individual cases, but that process can be arduous.

CVS Caremark has been the more aggressive of the two prescription insurers, listing roughly 130 drugs on its “we won’t pay” list. Express Scripts lists 85 and has a policy of not banning cancer drugs or mental health medications.

The threat of kicking drugs off their covered lists — which are known as formularies — is a powerful way to drive discounts, says Adam Fein, CEO of the Drug Channels Institute and author of a blog on prescription drug markets.

“Exclusions are one reason why discounts have been growing,” he tells Shots.

Express Scripts and CVS Caremark only started actively using their lists this way in 2012. Both firms claim they’ve already extracted huge savings for their customers: the health insurance companies and private corporations who hire them to manage their prescription drug plans.

CVS says its formulary management will save its customers $9 billion over the next five years.

For 2017, the company has excluded nine drugs that it deems “hyper-inflationary” — defined as “products with egregious cost inflation that have readily available, clinically appropriate and more cost-effective alternatives,” says Carolyn Castel, a spokeswoman for CVS Caremark.

The company specifically looks at drugs whose prices more than triple over three years, Castel says.

Those drugs include three skin creams that combine an over-the-counter ingredient, such as hydrocortisone or aloe, with a generic prescription drug to make a new and expensive brand name medication.

CVS manages prescription coverage for about 75 million people. For the first time in 2017 it is dropping from its list two so-called biologic drugs — the diabetes drug Lantus and Neupogen, a medicine commonly given to patients undergoing chemotherapy to help boost white blood cells and immunity. Instead, the company will pay for alternatives known as biosimilars. It was an important move; because of the way these drugs are made, biosimilars aren’t exact equivalents of the medications they replace.

But that’s part of the strategy of formulary exclusions. The managers of pharmacy benefits pit brand-name drugs that treat the same condition against each other, rather than waiting for generic drugs to come on the market and drive prices down.

Express Scripts covers about 85 million people, according to a recent investor presentation. Spokesman David Whitrap says the company tried to avoid excluding drugs; he recognizes the exclusions are an inconvenience to patients.

“Express Scripts will only ask members to switch their medication if there is a clinically equivalent alternative,” he tells Shots, “and only if that switch delivers a significant cost savings for their employer.”

For patients, the inconvenience can be minor, or it can be a real medical issue.

“From a consumer standpoint, you can wind up with a much bigger headache, with a lot more time invested in trying to sort out your prescriptions,” says Gill.

That’s because when the excluded medications don’t have generic alternatives that pharmacists can substitute automatically, patients have to go back to their doctor to get a prescription for a new drug.

“It’s a tricky trade-off,” says Jack Hoadley, a professor and researcher at Georgetown University’s Institute for Health Policy. “Am I getting enough of a discount to offset the inconvenience?”

Sometimes the drug on the approved list doesn’t work as well for some patients as the one that’s been kicked off.

“You end up having to switch to a drug that your prescriber thinks is less than optimal for treating your particular health condition,” Hoadley says.

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Where Lead Lurks And Why Even Small Amounts Matter

Katherine Du for NPR

Katherine Du for NPR

Lead problems with the water in Flint, Mich., have prompted people across the country to ask whether they or their families have been exposed to the toxic metal in their drinking water, too.

When it comes to assessing the risk, it’s important to look in the right places.

Even when municipal water systems’ lead levels are considered perfectly fine by federal standards, the metal can leach into tap water from lead plumbing.

Kate Gilles moved to the District of Columbia from Rhode Island for a job in international public health six years ago. When she was pregnant with her son, now 3, and her daughter, who turned 1 in July, she says paid close attention to her health.

She ate better. She exercised. She followed her doctor’s orders. Gilles checked off every task on the long list of things that she was supposed to do to help protect her babies.

But, that was before Flint, and it never occurred to her to test her drinking water for lead.

No one — not her pediatrician, not authorities at her local water utility and not the realtor who sold her the home she lives in — suggested that she might have a problem with lead.

In April, she learned that her home is one of more than an estimated 6 million in America that gets its water delivered through a lead service line.

When There’s Lead Underground

When there is a problem with lead in drinking water, service lines are the most likely culprit. Service lines are like tiny straws that carry water from a utility’s water main, usually running below the street, to each building.

In older cities, many of them in the Midwest and Northeast, these service lines can be made of pure lead.

Katherine Du for NPR

Katherine Du for NPR

Wherever lead service lines are in place, there is a risk of water contamination. The toxic metal can leach into the water whenever something jostles the pipes, like nearby construction, a heavy truck coming down the road or when the water just sits still for too long.

Civil engineer Marc Edwards, the Virginia Tech professor who helped document the lead problems with water in Flint, calls lead service lines “ticking time bombs.”

The Risks of Low-Level Lead Exposure

Dr. Bruce Lanphear has spent decades researching low-level lead exposure and his work is often cited by the Centers for Disease Control and Prevention. He says that while blood lead levels have been reduced drastically in recent decades, even levels as low as 5 micrograms per deciliter, can lower IQs and increase the risk of attention and behavioral problems in children. For adults, lead exposure can cause kidney problems and high blood pressure.

Other research documented a higher incidence of miscarriages during DC’s lead-in-water crisis as well as problems for fetuses when pregnant women are exposed to lead.

Because it would be unethical to expose people to a known toxin, clear data are lacking on exactly how much lead a person must be exposed to before it shows up in the blood or triggers health and behavioral problems. Public health officials say that removing all lead from a person’s environment is the best course of action.

Wherever lead service lines or other lead plumbing fixtures exist, there are precautions people can take to protect themselves — if they know they are risk. They can flush their pipes every morning. They can purchase a filter certified for lead removal. Ultimately, they can replace lead service lines and lead plumbing in the house, though those replacements can be costly.

Still, there aren’t any federal notification laws for the presence of lead plumbing as there are for lead paint. Checking the service line isn’t part of typical home inspections. Landlords aren’t required to warn tenants about lead pipes, and realtors don’t need to tell potential buyers.

Gilles, who has a master’s degree in public health, said she felt silly for not looking into lead risks from pipes. “But I also feel really angry that there’s nothing that flags it for homeowners,” she says.

Lead Regulations: “Illusion Of Safety” Or Protection?

After learning that her house has lead pipes, she ordered a test kit from DC Water, the local authority. When she got the results, she was more confused than relieved. The test showed 0.7 parts per billion of lead in the water, far below the EPA’s so-called action level, set at 15 parts per billion.

But what did the results mean? “I’m marveling at the total lack of lucidity of this letter,” she says. “Because it doesn’t say whether or not we need to be concerned. I’m guessing that the EPA decided that the margin of safety was this 15 parts per billion, and we’re under that.”

Except that isn’t at all what the EPA decided.

The EPA seeks to control lead in the drinking water with its Lead and Copper Rule, created in 1991. The rule says that, depending on factors like how big a city is and how long it has been since high lead levels were last detected, water utilities have to test the water in between 50 and 100 homes with lead service lines every six months to nine years.

If 90 percent of homes have lead below the 15 parts per billion action level, the water utility passes the test. Nothing has to change. If the utility fails the test, it has to take follow-up action, including more testing and possibly changing water treatment methods.

But, critics say, there are several problems with the EPA’s rule. For one, the most severe cases are essentially tossed out of the utilities’ reports.

Also, according to the EPA’s own research, the current lead sampling protocol requires water be collected immediately after the water has been stagnant for six hours. That means they are likely capturing the water that has been sitting inside the house, rather than the water that has been sitting in the lead service line. In other words, the utilities aren’t capturing the full extent of the problem.

In addition, critics say, the EPA’s trigger for action — or so-called action level — is set too high, at 15 parts per billion of lead in the water. Too many tests results above that threshold are a red flag for water utilities, a sign that they might have a lead problem.

The number is often cited as a threshold for public health, but no amount of lead is considered safe for human consumption.

Jeff Cohen helped develop the EPA’s Lead and Copper Rule back in the late ’80s. He says that the action level didn’t come from medical research; it came from water utilities.

“It was based on the little data was available at that time from water utilities in the U.S. that had installed different levels of corrosion control treatment,” he says.

Cohen points to the goal written into the rule, which is zero lead in drinking water. The action level, he says, is “not really designed to identify a safe level of lead in drinking water. It’s simply one of many pieces of data that should be used to determine whether corrosion control treatment is working or not.”

In June, the American Academy of Pediatrics called on federal regulators to tighten lead oversight, including lowering the action level. The Academy claimed that lead thresholds are set too high, they aren’t based on science and they create an “illusion of safety.” Dr. Lanphear was the lead author on the AAP policy.

“We’ve consistently said that no level of lead is safe,” says Joel Beauvias, the deputy assistant administrator for the EPA’s Office of Water. He said that the 15 parts per billion action level isn’t meant to be a threshold for public health.

The Safe Drinking Water Act says that the rule has to be updated every six years. The agency has been discussing possible revisions since 2010 and is looking at making improvements to the rule. But an agency spokesperson said it is too early to speculate on exactly what the agency will propose or when.

While the ultimate fix would be to replace all lead service lines and lead plumbing, that’s a daunting task. In the meantime, there is a call for greater transparency about where lead service lines are in use so that people can reduce their risks.

The EPA wrote governors in February across the country encouraging, but not requiring, disclosure.

After multiple inquiries from NPR, DC’s water utility published a map of the lead service lines it knows about. The map is incomplete; there are more than 13,000 homes on the map that may or may not have lead pipes. Still, the map gives residents — particularly renters – easier access to the utility’s records. In most cities, the information is still considered private and available only to the person paying the water bill.

George Hawkins, the general manager for DC Water, said it is in everyone’s best interest to make lead service line inventories public. The information helps homeowners manage risks in the short term and can encourage them to replace lead service lines

Although lead levels have gone down significantly in D.C. since the 2004 crisis, the majority of homes the utility has tested in recent years have still shown small amounts of lead in the water – 1 or 2 parts per billion.

Hawkins says that might be a problem, for certain households. “Were I [in] a household with a wife who was pregnant or small children, I’d want that number at zero or as close to zero as it can be,” Hawkins said.

Gillis decided that even small amounts of sporadic lead release wasn’t OK for her two children. She and her husband decided to have their lead service line replaced in May. It cost them $1,400.

She’s had both of her children tested for lead and is reassured by the results. But she’s still angry that no one told her about the lead service line – or the potential risk — earlier.

“The argument can be made that the onus was on us,” she says. “But we didn’t even know to look at it. This should really be the duty, the responsibility of the government.”

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In Battle Of Health Care Titans, Should Insurers Act Like Wal-Mart?

Who has the upper hand in health care prices?

Lorenzo Gritti for NPR

Retail giant Wal-Mart uses its market dominance to inflict “ruthless,” “brutal” and “relentless” pressure on prices charged by suppliers, business writers frequently report.

What if huge health insurance companies could push down prices charged by hospitals and doctors in the same way?

The idea is getting new attention as already painful health costs accelerate and major medical insurers seek to merge into three enormous firms.

Now that hospitals have themselves combined, in many cases, into companies that dominate their communities, insurance executives argue the only way to fight bigness is bigness.

No. 2 health insurer Anthem’s proposed marriage to No. 6 Cigna would let the combined company “manage the cost drivers that negatively impact affordability for consumers,” Anthem CEO Joseph Swedish told Congress last year. The bigger company could “negotiate better reimbursement rates” with medical providers, says Anthem spokeswoman Jill Becher.

In metro areas with only a few big insurers, hospital and doctor bills tend to be lower than economists would otherwise expect. If only one or two insurers are bidding to include providers in their networks, hospitals and doctors must submit to the offered deal or risk getting shut out of a huge piece of business.

“There’s some literature out there that does show that when you have relatively concentrated insurance markets, they tend to keep actual hospital costs down,” said Yevgeniy Feyman, a researcher at Harvard T.H. Chan School of Public Health and a fellow with the Manhattan Institute.

The American Hospital Association as well as the American Medical Association, trade groups for hospitals and doctors respectively, have long worried that insurance mergers do just that. Now that Anthem is trying to buy Cigna, and No. 3 health insurer Aetna wants to buy No. 5 Humana, they’re even more concerned.

Both deals “have the very real potential to reduce competition substantially” and “diminish the insurers’ willingness to be innovative partners with providers and consumers,” AHA lawyer Melinda Reid Hatton wrote to antitrust authorities after the combos were announced.

But hospitals have built their own market power through numerous mergers, giving them broad ability to raise prices paid by employers, taxpayers and consumers beyond what a competitive market would allow, economists argue.

Hospitals “are much more concentrated than insurance markets,” said Glenn Melnick, a health care economist at the University of Southern California who has researched the subject. “They face a lot less competition than the [health] plans do.”

Why not give hospital giants somebody their own size to negotiate with?

For one thing, insurers might just pocket higher profits from low provider prices instead of passing the savings to consumers and employers.

“I don’t find any evidence that reduction in provider payment leads to reduction in insurance premiums, and I don’t know of any study that does,” said Leemore Dafny, an expert in insurance markets and an economist at Harvard Business School.

Feyman suggests requiring insurers in concentrated areas to spend 90 percent of their revenue on medical care. That might reduce their ability to boost profits with premium increases while preserving their ability to hold down hospital and doctor costs, he said.

But he sees such a measure as only a “worst-case scenario” for the most monopolized insurance markets, not a recipe to allow the Anthem and Aetna deals to go through.

Antitrust regulators are siding with the hospitals and doctors.

In late July, the Justice Department sued to block both insurance mergers, arguing that competition is important to keep premiums down and that the deals “would leave much of the multitrillion-dollar health insurance industry in the hands of three mammoth insurance companies.”

They also rejected the Wal-Mart argument, which is related to what economists call “monopsony,” a concentration of buying power.

Monopsony is the opposite of monopoly: Instead of using market dominance to raise prices for consumers, huge buyers force down prices from suppliers. Wal-Mart is often described as holding monopsony-like power.

But critics of the insurance deals say monopsony can go too far. If the buyer pushes prices too low, suppliers stop producing, making needed goods and services unavailable.

“As a result of the merger, Anthem likely would reduce the rates that … providers earn by providing medical care to their patients,” the Justice Department argued. “This reduction in reimbursement rates likely would lead to a reduction in consumers’ access to medical care.”

Accepting Wal-Mart logic for health care might bolster arguments for an even bigger, more powerful buyer of medical services: the government.

A single-payer, government health system, of the type advocated by Democratic presidential candidate Bernie Sanders, would be the ultimate monopsony: one buyer, negotiating or dictating prices for everybody.

Neither the hospitals nor the insurance companies want that.

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Neither of them is affiliated with health insurer Kaiser Permanente. You can follow Jay Hancock on Twitter: @jayhancock1

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Social Security Data Errors Can Turn People Into The Living Dead

Bad data in means bad data out.

Bad data in means bad data out. Gary Waters/Ikon Images/Getty Images hide caption

toggle caption Gary Waters/Ikon Images/Getty Images

A few months ago, when Dr. Thomas Lee logged in to his patients’ electronic medical records to renew a prescription, something unexpected popped up. It was a notice that one of them had died.

Lee, a primary care doctor at Brigham and Women’s Hospital in Boston, was scheduled to see the patient in three days.

“I was horrified,” he says. The patient had been in his 80s, and his wife had died a few months before. “And everyone in medicine knows that when someone dies, there’s an increase in risk of death for their spouse over the next six months.”

He wanted to know what had happened, but he couldn’t find anything in the medical records or in a Web search. “I just felt really guilty that I had not pushed harder to get him in sooner,” says Lee. When he couldn’t find out anything, he decided to phone the man’s house to offer condolences — maybe even to apologize.

“So I called, and to my shock he answered,” says Lee. It was the patient, a retired professor living in Boston.

“I assume you’re calling about my death,” the man said.

“It gave me goose bumps,” says Lee. “I said, ‘Yeah, I guess I am.’ And then he explained to me what had happened.”

The professor explained that he’d been dealing with his own death for the past two weeks. It all started when he went to the ATM, only to find that he no longer had access to his bank account. When he went to the pharmacy to pick up his medicine, he found he no longer had health insurance.

Soon after, he got a letter in the mail from the Social Security Administration offering condolences about his recent loss of life and informing him that his monthly payments would end and that payments made since his “death” a few months prior would be removed from his bank account.

Because of a clerical error, the Social Security Administration believed he had died in December. That information had quickly spread to banks, pharmacies, hospitals. His doctor’s appointments had been wiped out and other patients had taken his place. Essentially, he’d been locked out of his life.

“It was a major nuisance, let’s put it that way,” he says. And to add insult to death, says the professor, “Social Security actually gave my date of death as the same date as my wife’s, which was really creepy. Not pleasant to see.”

He spent weeks on the phone trying to correct it all. In the process (which was reminiscent of a certain Monty Python skit), the man learned that because he had supposedly died, all his information — his full name, Social Security number, birthday and supposed death date — had been released to the public in a document called the Death Master File.

The publication of the file is a measure taken to prevent fraud, such as someone taking out a credit card in a deceased person’s name. But for those who are still living, the file is a recipe for identity theft. (That’s why we’re not naming the man.)

“I’m keeping an eye out fairly carefully to see if anything goes awry,” he says. “But it’s also somewhat amusing to know that you really are alive when everybody thinks you’re dead.” He even got a hug from a surprised doctor who didn’t expect him to show up for his canceled appointment, let alone in relatively good health.

It took about two months to resurrect him in the federal system.

And as Lee wrote this week in the New England Journal of Medicine, what happened to the professor happens to thousands of people each year.

“When we called the information system folks to bring him back to life, the response that we got was, ‘Oh no! Not another one,’ ” says Lee. There’s even a frequently asked question about it on the Social Security Administration’s website.

“And this is where I made the transition from thinking about this as something funny to something important,” says Lee. “We have a society where information travels quickly and there are many great things about it, but what if that information is wrong? There just is no process in most information systems for saying ‘Oops, we were wrong.’ “

In 2011, an audit found that about 1,000 people a month in the U.S. were marked deceased when they were very much alive. Rona Lawson, who works in the Office of the Inspector General at the Social Security Administration, says that number has gone down. It’s now around 500 people a month.

“But for those 500 people, it’s still a big impact on their lives, so we’d like to see the number even lower,” she says. Because most of them are Social Security clients, she says, they likely tend to be retired and over the age of 60.

Lawson says 90 percent of the time, the cascade of misinformation starts with an input error by Social Security staff — a regular mistake on a regular office day that just happens to kill a person off, at least on paper.

And she says the professor’s case, where someone is given the death date of their spouse, is fairly common.

“Oh, yes,” says Lawson. “That was a very common cause for the errors that we saw.”

In 2011, Congress passed legislation to remove a few pieces of information from the Death Master File – the state, county and ZIP code where a person lives or lived. And in 2013, based on recommendations by Lawson and her colleagues, Congress passed another piece of legislation to keep a person’s information from becoming public until 3 years after their death date. The change will kick in in late November.

“So, that’s an improvement — more time to get it right before it gets into the public domain and starts spreading to all the different websites and so forth,” says Lawson.

She says the information would still go to authorized users like banks and credit reporting agencies, so while the change might keep back identity thieves, it wouldn’t do much to prevent the headache that the retired academic went through.

“At least we can keep the information restricted to those who have a right to know it and not just everybody that has an Internet access point,” says Lawson.

But wait a minute. Putting aside the headache of having to convince everyone you’re still alive just so you can withdraw cash from an ATM, or pick up your prescriptions, might a fake death be seen as an opportunity? Maybe to disappear to a tropical island and start a new life?

“I never thought of that,” says the professor. “But that might have been an interesting way to proceed.”

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Hikes In Employees' Health Premiums To Outpace Raises Again

Imagezoo/Getty Images

Imagezoo/Getty Images

Large employers expect health costs to continue rising by about 6 percent in 2017, a moderate increase compared with historical trends that nevertheless far outpaces growth in the economy, two new surveys show.

“These cost increases, while stable, are both unsustainable and unacceptable,” said Brian Marcotte, CEO of the National Business Group on Health, a coalition of very large employers that got responses from 133 companies.

Employers are changing tactics to address the cost trend, slowing the shift to worker cost sharing and instead offering video or telephone links to doctors, scrutinizing costs of specialty drugs and steering patients to hospitals with records of lower costs and better results.

Most employees at large companies should expect a 5 percent increase in their premiums next year and, in contrast to previous years, “minimal changes” to plan designs, NBGH said.

The portion of employers offering high-deductible health plans next year — 84 percent — is essentially unchanged from 2016, according to the NBGH report. So is the percentage of companies offering high-deductible plans — 35 percent — as the only choice for workers and families.

Patients with high-deductible coverage pay thousands of dollars in medical costs before the insurance kicks in.

The idea is that sharing the pain makes employees smarter shoppers, prompting them to forgo unneeded tests and find the best price. But critics say available tools to shop for care are grossly inadequate.

Counting cost-control measures, companies responding to NBGH’s survey expect their net health expenses to rise by 5 percent next year. A survey of hundreds of employers by consultants Willis Towers Watson showed similar results.

“This is well above the cost-of-living increase,” said Julie Stone, health care practice leader at Willis Towers Watson. To control costs, “our clients are willing to do things that a few years ago employers might have been reluctant to do,” she said.

For what it’s worth, 5 percent or 6 percent is moderate compared with medical-cost growth in the early 2000s, when annual percentage increases reached double digits.

But it’s still far greater than recent increases in corporate profits and economic output. And it’s greater than the 3 percent increases in workers’ pay that many groups expect for 2017.

Economists partly blame the skimpy raises workers have received over the past decade on the ballooning resources employers had to devote to health spending.

Moderate cost trends in the large-employer market seemingly contrast with those in the Affordable Care Act’s online marketplaces, where plans sold to individuals are seeking premium increases of 10 percent or more.

But the variation has more to do with volatility in how insurance companies price their plans than with big differences in underlying costs, said Larry Levitt, a senior vice president with the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

Many marketplace plans underestimated costs for their members this year, forcing catch-up increases for 2017, he said.

New kinds of spending are driving health cost increases.

Even as hospital use has moderated, employers point to specialty drugs to fight cancer or hepatitis C that can cost tens or hundreds of thousands of dollars per patient as a new major contributor to health expense.

Nearly 1 in 3 companies said specialty drugs are the main factor in cost increases, according to the NBGH survey. Nine of 10 employers plan to install programs to manage specialty-drug costs, according to the Willis Towers Watson study.

Approaches include shifting drug coverage to large pharmacy benefit firms, which can deploy better buying power against the manufacturers, and infusing drugs at patients’ homes rather than in expensive hospitals, Stone said.

Employers are increasingly steering workers toward hospitals with records of higher quality results and fewer complications for expensive procedures such as fertility treatments and bariatric surgery. Until now companies have promoted such “centers of excellence” mainly for organ transplants.

They’re also encouraging remotely delivered preventive care by offering nurse coaches for the chronically ill via telephone and video conferencing to extend the hours of primary care clinicians.

Nine out of 10 large employers will offer such telehealth services next year in states that allow it, up from 70 percent this year, the NBGH survey shows.

Employers continue to shrink coverage for workers’ spouses, especially if spouses have access to a medical plan through their own workplace.

By 2018 Willis Towers Watson expects nearly half of large companies to charge an extra $100 or so a month to carry a working spouse on the plan — in addition to the regular premium contributions.

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. You can follow Jay Hancock on Twitter: @jayhancock1.

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Young Inventors Work On Secret Proteins To Thwart Antibiotic-Resistant Bacteria

Christian Choe, Zach Rosenthal, and Maria Filsinger Interrante, who call themselves Team Lyseia, strategize about experiments to test their new antibiotics.

Christian Choe, Zach Rosenthal, and Maria Filsinger Interrante, who call themselves Team Lyseia, strategize about experiments to test their new antibiotics. Linda A. Cicero/Stanford News /Courtesy of Stanford University hide caption

toggle caption Linda A. Cicero/Stanford News /Courtesy of Stanford University

Three college-age scientists think they know how to solve a huge problem facing medicine. They think they’ve found a way to overcome antibiotic resistance.

Many of the most powerful antibiotics have lost their efficacy against dangerous bacteria, so finding new antibiotics is a priority.

It’s too soon to say for sure if the young researchers are right, but if gumption and enthusiasm count for anything, they stand a fighting chance.

I met Zach Rosenthal, Christian Choe and Maria Filsinger Interrante in the lower level of the Shriram Center for Bioengineering & Chemical Engineering on the campus of Stanford University.

Filsinger Interrante just graduated from Stanford and is now in an M.D./Ph.D. program. Rosenthal and Choe are rising seniors.

Last October, Stanford launched a competition for students interested in developing solutions for big problems in health care. Not just theoretical solutions, but practical, patentable solutions that could lead to real products.

The three young scientists thought they had figured out a way to make a set of proteins that would kill antibiotic resistant bacteria.

They convinced a jury of Stanford faculty, biotech types and investors that they were onto something, and got $10,000 to develop their idea.

“And we want to see if our proteins are more effective at killing these resistant bacteria than what’s currently available,” says Filsinger Interrante.

Choe says there’s a reason industry hasn’t solved the antibiotic crisis.

Christian Choe seals a plate with E. coli bacteria that contain a ring of genetic material to produce the antibiotic protein.

Christian Choe seals a plate with E. coli bacteria that contain a ring of genetic material to produce the antibiotic protein. Linda A. Cicero/Stanford News /Courtesy of Stanford University hide caption

toggle caption Linda A. Cicero/Stanford News /Courtesy of Stanford University

“Big pharmaceutical companies aren’t that interested in pursuing antibiotics,” he says, “largely because the market size is small, and because bacteria develop resistance relatively quickly.”

But these young entrepreneurs think they’ve licked the resistance problem.

“The way that our proteins operate, that if the bacteria evolve resistance to them, actually the bacteria can no longer live anymore,” says Rosenthal. “We target something that’s essential to bacterial survival.”

Bacteria have managed to evolve a way around even the most sophisticated attempts to kill them, so I was curious to know more about how the proteins these young inventors say they’ve found worked.

“We’re not able to disclose, unfortunately,” says Filsinger Interrante. It’s their intellectual property, she explains, that they hope will attract investors. “We think that our protein has the potential to target very dangerous, multidrug-resistant bacteria.”

“I’ve been working in the field of antibiotics for the past 25 years and this is as good as any an idea as I’ve heard,” says Chaitan Khosla, a professor of chemical engineering and chemistry at Stanford. He’s also the director of a new program called ChEM-H, for Chemistry, Engineering & Medicine for Human Health, that’s supporting the students’ hunt for a new antibiotic.

But Khosla warns that many good ideas fall by the wayside, and even if the team’s proteins clear the initial hurdles, it would be years or decades before there’s a product ready to bring to market.

The trio are aware of the long odds. But for now, Rosenthal says they’re going to give it all they’ve got, even it means working late into the night, after classes and other commitments are finished.

“I lose some sleep, but I love what I’m doing, so it’s worth it,” he says.

The team reports preliminary results for their new antibiotic proteins are looking good, so all that work may be paying off.

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Hospital Units Tailored To Older Patients Can Help Prevent Decline

Nurse specialist Annelie Nilsson checks on patient Janet Prochazka, during her stay at the Zuckerberg San Francisco General Hospital, after Prochazka took a bad fall in March.

Nurse specialist Annelie Nilsson checks on patient Janet Prochazka, during her stay at the Zuckerberg San Francisco General Hospital, after Prochazka took a bad fall in March. Heidi de Marco/Kaiser Health News hide caption

toggle caption Heidi de Marco/Kaiser Health News

Until March of this year, Janet Prochazka was active and outspoken, living by herself and working as a special education tutor. Then a bad fall landed her in the Zuckerberg San Francisco General Hospital.

Doctors cared for her wounds and treated her pneumonia. But Prochazka, who is 75, didn’t sleep or eat well in the hospital, and became confused and agitated. Then she contracted a serious stomach infection.

Patients over 65 tend to be less resilient during a hospital stint than younger patients, research finds, and more vulnerable to mental or physical deterioration, even if they recover from the illness or injury that sent them there. One study published in 2011 found that about a third of patients older than 70 and more than half of patients over 85 left the hospital more disabled than when they arrived.

As a result, many previously independent seniors are unable to care for themselves after discharge, and need assistance with daily activities such as bathing, dressing or even walking.

“The older you are, the worse the hospital is for you,” says Dr. Ken Covinsky, a physician and researcher at the University of California, San Francisco’s division of geriatrics. “A lot of the stuff we do in medicine does more harm than good. And sometimes with the care of older people, less is more.”

As hospital staffs focus on treating the acute injury or illness, they may fail to ensure that older patients get adequate nutrition, he says, or fail to get them out of bed enough or control their pain adequately.

Hospital patients are often inadvertently restricted in their movements because of tethers to oxygen tanks and IV poles. They are subjected to various procedures and medications, and are often in noisy rooms, where careful monitoring means checking their vital signs at all hours of the night.

Ron Schwarz, 79, was hospitalized after falling in the shower. He spent time healing the Acute Care for Elders unit at San Francisco General, one of about 200 such units nationwide.

Ron Schwarz, 79, was hospitalized after falling in the shower. He spent time healing the Acute Care for Elders unit at San Francisco General, one of about 200 such units nationwide. Heidi de Marco/Kaiser Health News hide caption

toggle caption Heidi de Marco/Kaiser Health News

And if the drug side-effects, interrupted sleep, unappetizing food and long days in bed are annoying when we’re young, they can cause lasting damage as we get older, Covinsky says. Studies find that elderly patients often process medications differently than younger people, for example, and frequently have multiple medical problems, not just one.

Their needs are particular enough that some hospitals have established separate medical units to treat elderly patients.

San Francisco General is one such hospital. Its Acute Care for Elders ward, which opened in 2007, is staffed by a health team trained in geriatrics. They focus less on the original diagnosis and more on how to get patients back home, living as independently as possible.

Early on, for example, the staff tests patients’ memory and assesses how well they can walk and care for themselves at home. Patients are also encouraged from the start to do things for themselves as much as they are able throughout their stay. The health team removes catheters and IV tethers as soon as medically advisable, and supports patients in getting out of bed and eating in a communal dining area.

“Bed rest is really, really bad,” says the unit’s medical director, Dr. Edgar Pierluissi. “It sets off an explosive chain of events that are very detrimental to people’s health.”

Such units are still rare — there are only about 200 around the country. And even where they exist, not every elderly patient is admitted, in part because space is limited.

Prochazka initially went to the emergency room, and was admitted to the intensive care unit from there. She was transferred to ACE about a week later.

Though the move to the specialized unit helped Prochazka, her doctor says, it couldn’t completely restore her former health.

“She will not leave here where she started,” Pierluissi said several days before Prochazka was discharged. “She is going to be weaker and unable to do the things you really need to do to live independently.”

Still, the unit’s staff — a team that includes a doctor, a nurse, a pharmacist and a social worker — came up with a plan specifically for Prochazka’s needs that helped her heal. They weaned her off some of her medications. They got her up and walking. They also limited the disorienting night-time checks.

Prochazka says that, once on the unit, she got “the first good night of sleep I have had.” Ultimately, she was able to return home, and her health has continued to improve as she slowly regains strength.

How hospitals handle the old and very old is a pressing problem, geriatricians say. Nearly 13 million seniors are hospitalized each year — a trend that will only accelerate as baby boomers age.

Yet hospitals face few consequences if elderly patients become more impaired or less functional during their stay, Covinsky points out. The federal government penalizes hospitals when patients fall, get preventable infections, or return to the hospital within 30 days of their discharge, but the institutions aren’t held accountable if patients lose their memory while there or become so weak they can’t walk. As a result, most hospitals don’t measure those things.

“If you don’t measure it, you can’t fix it,” Covinsky says. The extra investment needed to create specialized units would pay off in the long run, he believes — for patients, hospitals and for the U.S., as it works to bring down health care spending.

ACE units have been shown to reduce hospital-inflicted disabilities in older patients, decrease lengths of stay and reduce the number of patients discharged to nursing homes. In one 2012 study published in the journal Health Affairs, researchers found that hospital units for the elderly saved about $1,000 per patient visit.

Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

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In Boston's 'Safe Space,' Surprising Insights Into Drug Highs

Tommy, a repeat patient at the Supportive Place for Observation and Treatment in Boston, says the room has saved lives.

Tommy, a repeat patient at the Supportive Place for Observation and Treatment in Boston, says the room has saved lives. Jesse Costa/WBUR hide caption

toggle caption Jesse Costa/WBUR

Some arrive on their own, worried about what was really in that bag of heroin. Some are carried in, slumped between two friends. Others are lifted off the sidewalk or asphalt of a nearby alley and rolled in a wheelchair to what’s known as SPOT, or the Supportive Place for Observation and Treatment, at the Boston Health Care for the Homeless Program.

Nine reclining chairs have been full most days, especially during peak midday hours. It may be the only room in the country when patients can ride out a heroin or other high under medical supervision.

“It’s a safe place to be,” says Tommy, 39, who’s been using heroin for at least 21 years. “It’s a lot safer than being out on the street, possibly walking into traffic. I might OD if I was alone out there.”

Tommy is looking for a job and housing, and we’ve agreed not to use his full name. He’s one of 180 people who’ve come to this former conference room to ride out an opioid or other drug high since SPOT opened in late April. Nurses have logged almost 900 visits. At least half of the patients have come more than once.

If the person can speak, a nurse will ask what they took before settling them in a chair, wrapping a blood pressure cuff around one arm and placing an oxygen monitor over a finger.

“The monitors are really convenient,” Dr. Jessie Gaeta, chief medical officer for BHCHP, says as she pulls the Velcro edges of a blood pressure cuff apart. “It takes a lot of the guessing out of understanding how far someone is into an overdose syndrome.”

Gaeta coined the term “overdose syndrome” to describe what’s happening to patients in this room. In many cases, she is surprised by what she’s seeing.

“A classic opiate overdose is characterized by a person who stops breathing,” Gaeta says. “They have central nervous system depression. So it’s mostly respiratory depression and respiratory arrest.”

But Gaeta says about 75 percent of her SPOT room patients show something different. “What we’re seeing in this room is more depression of heart rates and blood pressures as actually the primary — sometimes the only — abnormalities,” Gaeta says. So the patient may be unconscious with low blood pressure, but have nearly normal breathing.

Dr. Jessie Gaeta, chief medical officer of the Boston Health Care for the Homeless Program, stands at a setup where heroin users would be monitored while riding out a high.

Dr. Jessie Gaeta, chief medical officer of the Boston Health Care for the Homeless Program, stands at a setup where heroin users would be monitored while riding out a high. Jesse Costa/WBUR hide caption

toggle caption Jesse Costa/WBUR

Patients tell Gaeta they may start the day with heroin or another opioid and then, a few hours later, take pills that will enhance the high.

“People are talking about that a lot here,” Gaeta says, “about the layering of this cocktail of medications and that’s really reflected in the vital signs that we’re seeing, which is not indicative of pure opiate overdoses. I’m not sure that we’d have seen that without doing this kind of monitoring.”

Gaeta describes a typical combination or cocktail of four drugs: heroin or another opioid, clonidine (which lowers blood pressure), Klonopin (to control for anxiety) and gabapentin (used to treat seizures or nausea).

The observations are just a snapshot based on a small number of addiction patients in one area of Boston. But what Gaeta is seeing in is reflected in overdose death reports and is changing the way she and her staff respond to these patients who look like they are falling into a deep sleep. To boost sinking blood pressures, for example, they’ve brought IV fluid equipment into the room. They are going through many more tanks of oxygen than expected.

Dr. Barbara Herbert, president of the Massachusetts chapter of the American Society of Addiction Medicine, says she’s never heard anyone use the term overdose syndrome. “But I think it’s a great phrase, and I suspect it will move into more conversations. Because we created a safe space, can now think about what’s in front of us with more science than we could before we had this,” she says. “So while all of us knew this cocktail could produce overdose, few of us have ever had the opportunity of seeing people after they use and monitoring their blood pressure or their heart rate. So, this is an unexpected positive for us, coming to understand the disease better from that safe space.”

SPOT nurse April Donahue says some patients in the room appear so sedated that they don’t respond when she speaks loudly in their ear or raps on their sternum. But, she says, some of those people, “have rock solid vital signs, better than mine.” So, she says, “What you see subjectively looking at someone and what their vital signs are, don’t always match up.”

If Donahue weren’t monitoring the vital signs, she says she’d be racing to inject naloxone, the drug that reverses the effects of opioids. But Donahue found she can sometimes avoid using naloxone, which is very harsh on the body, by giving patients oxygen or fluids to keep patients alive.

The facility is going through many more tanks of oxygen than expected because of what medical staff are learning about what's going on in the body while people are high.

The facility is going through many more tanks of oxygen than expected because of what medical staff are learning about what’s going on in the body while people are high. Jesse Costa/WBUR hide caption

toggle caption Jesse Costa/WBUR

The nurses speak to each patient about addiction treatment. Getting patients into treatment is their top priority after keeping people safe while high.

“I think what’s struck me the most is the gratitude — just to get out of that environment, even for a little while, to get off the street and be cared for,” Donahue says. “I mean, so many of our participants don’t have anyone who’s caring for them.”

It’s one reason Tommy is becoming a repeat client. “This is just a great start,” Tommy says. “I think it will slow down a lot of overdoses and could save a lot of lives. It will save a lot of lives in the long run.”

And Tommy knows. He went into respiratory failure a few weeks ago while at SPOT and was brought back with naloxone.

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

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Federal Officials Seek To Stop Social Media Abuse Of Nursing Home Residents

An inspection found that at one Los Angeles nursing home an employee took video of a co-worker "passing gas" on the face of a resident and posted it on Instagram.

Editor’s note: This story contains language that some may find offensive.

An inspection found that at one Los Angeles nursing home an employee took video of a co-worker “passing gas” on the face of a resident and posted it on Instagram. Universal Images Group/Getty Images hide caption

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Federal health regulators have announced plans to crack down on nursing home employees who take demeaning photographs and videos of residents and post them on social media.

The move follows a series of ProPublica reports that have documented abuses in nursing homes and assisted living centers using social media platforms such as Snapchat, Facebook and Instagram. These include photos and videos of residents who were naked, covered in feces or even deceased. They also include images of abuse.

The Centers for Medicare and Medicaid Services, which oversees nursing homes, said in a memo to state health departments on Friday that they should begin checking to make sure that all nursing homes have policies prohibiting staff from taking demeaning photographs of residents. The memo also calls on state officials to quickly investigate such complaints and report offending workers to state licensing agencies for investigation and possible discipline. State health departments help enforce nursing home rules for the federal government.

“Nursing homes must establish an environment that is as homelike as possible and includes a culture and environment that treats each resident with respect and dignity,” said the memo signed by David Wright, director of the CMS survey and certification group. “Treating a nursing home resident in any manner that does not uphold a resident’s sense of self-worth and individuality dehumanizes the resident and creates an environment that perpetuates a disrespectful and/or potentially abusive attitude towards the resident(s).”

CMS said that nursing homes have a responsibility to protect residents’ privacy, to prohibit abuse, to provide training on how to prevent abuse and to investigate all allegations of abuse. If homes fail to do so, they can face citations, fines and theoretically even termination from the Medicare program.

Also last week, Sen. Charles Grassley, R-Iowa and chairman of the Senate Judiciary Committee, called on other federal agencies to take action on the problem. He sent letters to the Department of Justice and to the Office for Civil Rights within the Department of Health and Human Services asking whether “rules and protections are in place to prevent and punish these types of abuses.” He also has sent letters to social media companies, calling on them to pay more attention to this. The Office for Civil Rights is working on its own guidance related to social media but hasn’t released it yet.

In a statement to ProPublica, Grassley praised the new CMS memo. “This guidance is welcome and necessary,” he wrote. “Nursing homes are obligated under the law to keep their residents free from abuse. Exploitation on social media is a form of abuse, and the agency memo makes that clear. We need to prevent it, and we need to punish it when it happens.”

ProPublica has identified 47 instances since 2012 in which workers at nursing homes and assisted-living centers shared photos or videos of residents on social media networks. This includes three discovered in recent weeks. At one Los Angeles nursing home, an employee took video of a co-worker “passing gas” on the face of a resident and posted it on Instagram, according to a May inspection report.

“An interview was conducted with Resident 1 and the resident stated that facility employees pass gas in his face as often as every month,” the report said. One employee resigned and a police report was filed.

While some states have taken harsh steps against nursing homes at which social media abuse occurs, other states have not. We reported last month that Iowa health officials recently discovered it wasn’t against state law for a nursing home worker to share a photo on Snapchat of a resident covered in feces because his genitals weren’t visible. Officials are trying to change the law when the Iowa Legislature reconvenes early next year.

The federal government memo sets uniform standards for how such abuse should be written up by inspectors and the severity of sanctions that should be levied. In the past, there was great variability.

Last month, the industry’s trade group issued its own suggestions for dealing with such situations, encouraging training and swift responses by these facilities when allegations are brought to light. The group also is holding training events around the country. While many facilities ban the use or possession of cell phones by employees when in resident areas, some have also found such rules impractical to enforce.

Greg Crist, a spokesman for the American Health Care Association, the trade group, said the CMS memo dovetails with the industry’s effort to stop social media abuse.

“The two words in that CMS directive that stand out most to me are ‘privacy’ and ‘responsibility,’ ” Crist wrote in an email Monday. “That’s why we have taken responsibility and made a concerted, nationwide effort to educate and share best practices with our centers not only on how to detect and root out this abuse, but also proactive steps to ensure it doesn’t happen in the first place.

“It’s not an issue that is conquered overnight,” he wrote, “but every day, we get smarter about it.”

Has your medical privacy been compromised? Help ProPublica investigate by filling out a short questionnaire. You can also read other stories in our Policing Patient Privacy series.

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Zika Cases Surge In Puerto Rico As Mosquitoes Flourish

A health department pickup truck sprays insecticide against mosquitoes in a San Juan, Puerto Rico, neighborhood in January.

A health department pickup truck sprays insecticide against mosquitoes in a San Juan, Puerto Rico, neighborhood in January. Alvin Baez/Reuters hide caption

toggle caption Alvin Baez/Reuters

The Zika outbreak in Puerto Rico is expanding rapidly.

Recently, the island has been reporting more than a thousand new cases of Zika each week.

The situation is expected to get worse before it gets better.

“We are right now probably in the month or 6 weeks of peak transmission,” says Tyler Sharp the lead epidemiologist for the Centers for Disease Control and Prevention’s Zika operation in Puerto Rico.

Previous outbreaks of dengue fever and chikungunya, which are transmitted by the same mosquito as Zika, Aedes aegypti, suggest the hot, wet summer months in Puerto Rico now are just right for Zika to flourish, Sharp says.

“The more rains you get, the more mosquitoes you get. The more mosquitoes, the higher the rate of transmission,” he says. “And also the mosquitoes like warmer temperatures and are able to replicate the virus more efficiently at at least slightly higher temperatures.”

He calls August in Puerto Rico the “Goldilocks zone” for Zika virus replication.

The island has already had more than 8,000 confirmed cases of Zika. The CDC predicts that by the end of the year, 20 percent to 25 percent of the roughly 3.5 million people on the island could be infected with the virus.

Many of those people would have mild symptoms or even none at all. But such a widespread outbreak means that thousands of pregnant women could be exposed and their babies might be at risk of having severe Zika-related birth defects.

And the tools to fight Zika are limited.

Public health officials weren’t able to stop previous outbreaks of dengue and chikungunya while they were in progress, Sharp notes. Zika is even more complicated because it’s transmitted by both mosquitoes and sexually activity.

“So we have things that we think can be effective,” he says. “We know that individuals can take approaches to reduce their risk of infection. But in terms of breaking the epidemic, or stopping transmission, there’s nothing that we know about that’s been scientifically evidenced to show that this will work, that this is the solution.”

There’s no silver bullet.

Even the insecticides that are being used to spray homes or fog some high-risk neighborhoods have been losing their punch. Mosquitoes have been developing resistance to them.

“What we’ve seen in Puerto Rico, as we see in many regions, is that there is a wide variety of resistance not to all insecticides but to many of them,” Sharp notes. “And that [resistance] can change over time depending on what’s being used in the communities, in the population.”

A plan for aerial spraying of an insecticide called Naled caused an uproar here. San Juan’s mayor called the plan “environmental terror” and late last month the governor blocked the proposal. Naled is the same chemical that’s being sprayed from planes over parts of Miami to combat Aedes aegypti mosquitoes there.

Sharp says the efforts against Zika in Puerto Rico rely primarily on people. People protecting themselves from mosquito bites and people attacking mosquito breeding grounds. The only good news is that if previous outbreaks of dengue and chikungunya are any guide, the high levels of Zika transmission here should start to fall in September or October.

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