A federal judge in March invalidated large chunks of the law that created association health plans. But many of the plans are still operating and waiting to see if the Trump Administration appeals the ruling.
This article was first published on Thursday, April 25, 2019, in Kaiser Health News.
When the Trump administration in June issued rules making it easier for small employers to band together to buy health insurance, "we started looking immediately," recalled Scott Lyon, a top executive at the Small Business Association of Michigan.
Although he offered traditional small-group health insurance to his association's employees and members, Lyon liked adding a new option for both: potentially less expensive coverage through an association health plan, which doesn't have to meet all the rules of the Affordable Care Act.
Now, a few months in, "we've got 400 companies and a couple of thousand workers signed up," said Lyon last week.
Nationally, an estimated 30,000 people are in such association health plans, a type of health insurance seeing a nascent resurgence following an initial drop-off after the ACA took effect in 2014.
Most of the new enrollees joined through groups like Lyon's or local chambers of commerce, farm bureaus or agriculture-based cooperatives. Such groups see the plans not only as a way to offer insurance, but also as an enticement to boost membership.
In the first legal test, however, U.S. District Judge John Bates at the end of March sided with 11 states and the District of Columbia challenging the law. He invalidated a large chunk of those June rules, saying the administration issued them as an "end-run around the Affordable Care Act."
So what now?
Unless the government seeks — which it has yet to do — and is granted a stay of the judge's order, "plans formed under the vacated sections of the rule are illegal," said Timothy Jost, an emeritus health law professor from Washington and Lee University.
Still, that won't mean anything for existing plans if the states or federal regulators choose not to enforce the ruling, Jost said.
And that could cause more confusion in the marketplace.
While the states that brought the challenge are expected to enforce the ruling, some other states support broader access to association health plans, said Christopher Condeluci, an attorney who represents several such plans, including the one formed by Lyon's group.
"These plans are not an end run around the ACA," said Condeluci.
Association health plans already established under the administration's rules cover "virtually" all the federal law's essential health benefits, he said, with the exception of dental and vision care for children.
Local chamber of commerce plans are mainly continuing business as usual while watching to see if the government will appeal, said Katie Mahoney, vice president of health policy at the U.S. Chamber of Commerce.
A few, including a plan offered through the Las Vegas chamber, may limit new enrollment for sole proprietors, she said, as the judge sharply questioned whether they qualified as "employers" under federal laws.
Sole proprietors are generally individuals who own and operate their own businesses without any employees.
Bates wrote that, in the regulation, the Department of Labor "stretches the definition of employer" beyond what federal law allows. The rule was designed to increase access to plans that "avoid the most stringent requirements" of the ACA.
The opinion by Bates, who was appointed by President George W. Bush, is widely expected to be appealed, although the government has not yet done so.
The decision affects one pillar of a broader effort by the Trump administration to expand access to less expensive health insurance. Association plans have long been a favorite of Republicans, existing before the ACA. Supporters say they are one way to pool groups of businesses together to get better premium rates.
Still, some plans faced problems in the past, including bankruptcy or complaints that they misled consumers by not fully informing them about what is covered.
After the ACA took effect, enrollment fell, partly because many small businesses were buying new ACA plans and many existing association plans had to comply with ACA rules for small-group coverage anyway. People who ran their own businesses and had no employees qualified only for coverage through the ACA's individual market.
But the Trump administration in June broadened the definition of those eligible to buy insurance through employer-based associations to include sole proprietors and also made it easier to form associations to offer coverage.
In addition, the changes allowed more association plans to be classified as large-employer coverage, which exempts them from some of the ACA's requirements. For example, association plans don't have to include all 10 of the ACA's "essential" health benefits, such as mental health care and prescription drug coverage.
Also, unlike ACA plans, association insurers can set premium rates based on an employer's industry, as well as taking into account the age range and gender makeup of their workforce.
In other words, association plans can charge less for companies with workforces that are generally younger and male in occupations that involve mainly desk work than for firms with mostly older workers or companies doing riskier work, such as cutting down trees or roofing.
Still, such plans must abide by other ACA provisions, including accepting people with preexisting medical conditions.
Critics, including the states that sued, say the new rules and other administration-backed changes will weaken the market for ACA plans by drawing out younger and healthier people. The states also argued that the new rules would be costly for them to administer, alleging they would have to devote more resources to preventing consumer fraud.
In Michigan, Lyon said the association his group formed, called Transcend, offers coverage to small employers and sole proprietors that is just as generous as large-group plans. It is a fully insured plan through the state's Blue Cross Blue Shield carrier that covers a broad array of benefits, except children's dental and vision.
"One thing we don't want to do is sell a bag of air to our members," said Lyon.
While some new members have reported large savings by enrolling, Lyon said association plans are not necessarily less expensive than small-group coverage. It all depends on the demographic and occupational makeup of the small business, he said.
"Our best estimate was association health plans would be the right solution for 30 to 35% of the small-group world," said Lyon. "It all has to come together. Age matters. Gender matters. It's so specific to each company."
About 1 in 4 people in the U.S. have fatty liver disease. But among Latinos, especially of Mexican and Central American descent, the rate is significantly higher.
Saira Diaz uses her fingers to count the establishments selling fast food and sweets near the South Los Angeles home she shares with her parents and 13-year-old son. "There's one, two, three, four, five fast-food restaurants," she says. "And a little mom and pop store that sells snacks and sodas and candy."
In that low-income, predominantly Latino neighborhood, it's pretty hard for a kid to avoid sugar. Last year, doctors at St. John's Well Child and Family Center, a nonprofit community clinic seven blocks away, became alarmed by the rising weight of Diaz's son, Adrian Mejia. They persuaded him to join an intervention study run by the University of Southern California and Children's Hospital Los Angeles (CHLA) that weans participants off sugar in an effort to reduce the rate of obesity and diabetes among children.
It also targets a third condition fewer people have heard of: fatty liver disease.
Linked both to genetics and diets high in sugar and fat, "fatty liver disease is ripping through the Latino community like a silent tsunami and especially affecting children," said Dr. Rohit Kohli, chief of gastroenterology, hepatology and nutrition at CHLA.
Recent research shows about 1 in 4 people in the U.S. have fatty liver disease. But among Latinos, especially of Mexican and Central American descent, the rate is significantly higher. One large study in Dallas found that 45% of Latinos had fatty livers.
The USC-CHLA study is led by Michael Goran, director of the Diabetes and Obesity Program at CHLA, who last year made an alarming discovery: Sugar from sweetened beverages can be passed in breast milk from mothers to their babies, potentially predisposing infants to obesity and fatty livers.
Called HEROES, for Healthy Eating Through Reduction of Excess Sugar, his program is designed to help children like Adrian, who used to drink four or more sugary drinks a day, shed unhealthy habits that can lead to fatty liver and other diseases.
Fatty liver disease is gaining more attention in the medical community as lawmakers ratchet up pressure to discourage the consumption of sugar-laden drinks. Legislators in Sacramento are mulling proposals to impose a statewide soda tax, put warning labels on sugary drinks and bar beverage companies from offering discount coupons on sweetened drinks.
"I support sugar taxes and warning labels as a way to discourage consumption, but I don't think that alone will do the trick," Goran said. "We also need public health strategies that limit marketing of sugary beverages, snacks and cereals to infants and children."
William Dermody, a spokesman for the American Beverage Association said: "We understand that we have a role to play in helping Americans manage consumption of added sugars, which is why we are creating more drinks with less or no sugar."
In 2016, 45 deaths in Los Angeles County were attributed to fatty liver disease. But that's a "gross underestimate," because by the time people with the illness die, they often have cirrhosis, and that's what appears on the death certificate, said Dr. Paul Simon, chief science officer at the L.A. County Department of Public Health.
Still, Simon said, it was striking that 53% of the 2016 deaths attributed to fatty liver disease were among Latinos — nearly double their proportion of total deaths in the county.
Medical researchers consider fatty liver disease a manifestation of something called metabolic syndrome — a cluster of conditions that include excess belly fat and elevated blood pressure, blood sugar and cholesterol that can increase the risk of heart disease, stroke and diabetes.
Until 2006, few doctors knew that children could get fatty liver disease. That year Dr. Jeffrey Schwimmer, a professor of pediatrics at the University of California-San Diego,reviewed the autopsies of 742 children and teenagers, ages 2 to 19, who had died in car crashes or from other causes, and he found that 13% of them had fatty liver disease. Among obese kids, 38% had fatty livers.
After Schwimmer's study was released, Goran began using MRIs to diagnose fatty liver in living children.
A 2008 study by another group of researchers nudged Goran further. It showed that a variant of a gene called PNPLA3 significantly increased the risk of the disease. About half of Latinos have one copy of that high-risk gene, and a quarter have two copies, according to Goran.
He began a new study, which showed that among children as young as 8, those who had two copies of the risky gene and consumed high amounts of sugar had three times as much fat in their livers as kids with no copy of the gene. Now, in the USC-CHLA study, he is testing whether reduced consumption of sugar decreases the fatty liver risk in children who have the PNPLA3 gene variant.
At the start of the study, he tests kids to see if they have the PNPLA3 gene, uses an MRI to measure their liver fat and catalogs their sugar intake. A dietitian on his team educates the family about the impact of sugar. Then, after four months, they measure liver fat again to assess the impact of the intervention. Goran expects to have results from the study in about a year.
More recently, Goran has been investigating the transmission of sugar from mothers to their babies. He showed last year that in nursing mothers who drank beverages sweetened with high-fructose corn syrup — the primary sweetener in standard formulations of Coca-Cola,Pepsi and other sodas — the fructose level in their breast milk rose and stayed elevated for several hours, ensuring that the baby ingested it.
This early exposure to sugar could be contributing to obesity, diabetes and fatty livers, based on previous research that showed fructose can enhance the fat storage capacity of cells, Goran said.
At Torrance Memorial Medical Center, Dr. Karl Fukunaga meets with a patient, Margarita Marrou, a retired medical clerk originally from Peru. She was diagnosed several years ago with a severe form of fatty liver disease and has cut down her sugar consumption and lost weight. (Rob Waters for KHN)
In neighborhoods like South Los Angeles, where Saira Diaz and Adrian Mejia live, a lack of full-service markets and fresh produce makes it harder to eat healthily. "Access to unhealthy food options — which are usually cheaper — is very high in this city," Derek Steele, director of health equity programs at the Social Justice Learning Institute in Inglewood, Calif., told Kaiser Health News.
The institute has started farmers markets, helped convert two corner stores into markets with healthier food options and created 109 community gardens on public and private lands in South L.A. and neighboring Inglewood, which has 125 liquor and convenience stores and 150 fast-food outlets.
At Torrance Memorial Medical Center, 10 miles down the road, Dr. Karl Fukunaga, a gastroenterologist with Digestive Care Consultants, said he and his colleagues are seeing so many patients with fatty liver disease that they plan to start a clinic to address it. He urges his patients to avoid sugar and cut down on carbohydrates.
Adrian Mejia and his mother received similar advice from a dietitian in the HEROES program. Adrian gave up sugary beverages, and his liver fat dropped 43%. Two months ago, he joined a soccer league.
"Before, I weighed a lot and it was hard to run," he said. "If I kept going at the pace I was going, probably later in my life I would be like my [diabetic] grandma. I don't want that to happen."
Compared with urban hubs, rural populations tend to have less access to public health resources, less experience with syphilis and less willingness to address it because of socially conservative views.
This article was first published on Thursday, April 18, 2019 in Kaiser Health News.
When Karolyn Schrage first heard about the "dominoes gang" in the health clinic she runs in Joplin, Mo., she assumed it had to do with pizza.
Turns out it was a group of men in their 60s and 70s who held a standing game night — which included sex with one another. They showed up at her clinic infected with syphilis.
That has become Schrage's new normal. Pregnant women, young men and teens are all part of the rapidly growing number of syphilis patients coming to the Choices Medical Services clinic in the rural southwestern corner of the state. She can barely keep the antibiotic treatment for syphilis, penicillin G benzathine, stocked on her shelves.
Public health officials say rural counties across the Midwest and West are becoming the new battleground. While syphilis is still concentrated in cities such as San Francisco, Atlanta and Las Vegas, its continued spread into places like Missouri, Iowa, Kansas and Oklahoma creates a new set of challenges. Compared with urban hubs, rural populations tend to have less access to public health resources, less experience with syphilis and less willingness to address it because of socially conservative views toward homosexuality and nonmarital sex.
In Missouri, the total number of syphilis patients has more than quadrupled since 2012 — jumping from 425 to 1,896 cases last year — according to a Kaiser Health News analysis of new state health data. Almost half of those are outside the major population centers and typical STD hot spots of Kansas City, St. Louis and its adjacent county. Syphilis cases surged at least eightfold during that period in the rest of the state.
At Choices Medical Services, Schrage has watched the caseload grow from five cases to 32 in the first quarter of 2019 alone compared with the same period last year. "I've not seen anything like it in my history of doing sexual healthcare," she said.
Back in 1999, the Centers for Disease Control and Prevention had a plan to eradicate the sexually transmitted disease that totaled over 35,000 cases nationwide that year. While syphilis can cause permanent neurological damage, blindness or even death, it is both treatable and curable. By focusing on the epicenters clustered primarily throughout the South, California and in major urban areas, the plan seemed within reach.
Instead, U.S. cases topped 101,500 in 2017 and are continuing to rise along with other sexually transmitted diseases. Syphilis is back in part because of increasing drug use, but health officials are losing the fight because of a combination of cuts in national and state health funding and crumbling public health infrastructure.
"It really is astounding to me that in the modern Western world we are dealing with the epidemic that was almost eradicated," said Schrage.
Grappling With The Jump
Craig Highfill, who directs Missouri's field prevention efforts for the Bureau of HIV, STD and Hepatitis, has horror stories about how syphilis can be misunderstood.
"Oh, no, honey, only hookers get syphilis," he said one rural doctor told a patient who asked if she had the STD after spotting a lesion.
In small towns, younger patients fear that their local doctor — who may also be their Sunday school teacher or basketball coach — may call their parents. Others don't want to risk the receptionist at their doctor's office gossiping about their diagnosis.
Some men haven't told family members they're having sex with other men. And still more have no idea their partner may have cheated on them — and their doctors don't want to ask, according to Highfill.
It's even hard to expect providers who haven't seen a case of syphilis in their lifetime to automatically recognize the hallmarks of what is often called the "great imitator," Highfill said. Syphilis can manifest differently among patients, but frequently shows up for a few weeks as lesions or rashes — often dismissed by doctors who aren't expecting to see the disease.
Since 2000, the current syphilis epidemic was most prevalent among men having sex with men. Starting in 2013, public health officials began seeing an alarming jump in the number of women contracting syphilis, which is particularly disturbing considering the deadly effects of congenital syphilis — when the disease is passed from a pregnant woman to her fetus. That can cause miscarriage, stillbirth or birth deformities.
Among those rising numbers of women contracting syphilis and the men who were their partners, self-reported use of methamphetamines, heroin or other intravenous drugs continues to grow, according to the CDC. Public health officials suggest that increased drug use — which can result in a pattern of risky sex or trading sex for drugs — worsens the outbreaks.
That perilous trend is playing out particularly in rural Missouri, argues Dr. Hilary Reno, an assistant professor of medicine at Washington University School of Medicine in St. Louis who is researching syphilis transmission and drug use in the state. Tracking cases from 2015 through June 2018, she found that more than half of patients outside of the major metropolitan areas of Kansas City and St. Louis reported using drugs.
Less Money, More Problems
Federal funding for STD prevention has stayed relatively flat since 2003, with $157.3 million allocated for fiscal year 2018. But that amounts to a nearly 40% decrease in purchasing power over that time, according to the National Coalition of STD Directors.
In Missouri, CDC annual funding has been cut by over $354,000 from 2012 to 2018 — a 17% decrease even as the number of cases quadrupled, Highfill said.
Iowa, too, has seen its STD funding cut by $82,000 over the past decade, according to Iowa Department of Health's STD program manager George Walton.
"It is very difficult to get ahead of an epidemic when case counts are steadily — sometimes rapidly — increasing and your resources are at best stagnant," Walton said. "It just becomes overwhelming."
Highfill bemoaned that legislatures in Texas, Oregon and New York have all allocated state money to raise awareness or provide transportation to local clinics. Missouri has not allocated anything.
A New Playing Field
In the digital age, fighting syphilis is much harder for public health responders, said Rebekah Horowitz, a senior program analyst on HIV, STDs and viral hepatitis at the National Association of County and City Health Officials.
The increased use of anonymous apps gives people greater access to more sexual partners, she said. Tracking down those partners is now much harder than camping out at the local bar in town.
"We can't get inside of Grindr and do our traditional public health efforts," she said.
That's not to say Highfill's department hasn't tried. It has engineered a series of educational ads on Instagram, Grindr and Facebook displaying messages such as "Knowledge looks good on you."
Highfill would love to do more — if Missouri had the money.
Public health clinics nationwide have also had to limit hours, reduce screening and increase feesthat can reach $400. And some run by health departments across the country have been forced to close — at least 21 in 2012 alone, according to CDC data.
In Missouri, restrictions on Planned Parenthood's Medicaid reimbursements that were passed last year in the legislature, and are again under debate, mean the nonprofit organization cannot be reimbursed for STD treatment for some patients.
That is another crack in the already failing public health infrastructure, said Reno, the Washington University professor who also serves as the medical director of the St. Louis County Sexual Health Clinic.
"We have a system that's not even treading water," she said. "We are the ship that is listing to the side."
Workers in the wellness programs self-reported healthier behavior, but saw no differences in health measures, such as improved blood sugar, how much they spent on healthcare, or how often they missed work.
This article was first published on Tuesday, April 16, 2019 byKaiser Health News.
Workplace wellness programs have become an $8 billion industry in the U.S. But astudy published Tuesday in JAMA found they don't cut costs for employers, reduce absenteeism or improve workers' health.
Most large employers offer some type of wellness program — with growth fueled by incentives in the federal Affordable Care Act.
A host of studies over the years have provided conflicting results about how well they work, with some showing savings and health improvements while others say the efforts fall short.
Many studies, however, faced a number of limitations, such as failing to have a comparison group, or figuring out whether people who sign up for such wellness programs are somehow healthier or more motivated than those who do not.
Now researchers from the University of Chicago and Harvard may have overcome these obstacles with one of the first large-scale studies that is peer-reviewed and employs a more sophisticated trial design.
They randomly assigned 20 BJ's Wholesale Club outlets to offer a wellness program to all employees, then compared results with 140 stores that did not.
The big-box retailer employed nearly 33,000 workers across all 160 clubs during the test.
After 18 months, it turned out that yes, workers participating in the wellness programs self-reported healthier behavior, such as exercising more or managing their weight better than those not enrolled.
But the efforts did not result in differences in health measures, such as improved blood sugar or glucose levels; how much employers spent on health care; or how often employees missed work, their job performance or how long they stuck around in their jobs.
"The optimistic interpretation is there is no way we can get improvements in health or more efficient spending if we don't' first have changes in health behavior," said one study author, Katherine Baicker, dean of the Harris School of Public Policy at the University of Chicago. (Dr. Zirui Song, an assistant professor of health policy and medicine at Harvard Medical School, was its co-author.)
"But if employers are offering these programs in hopes that health spending and absenteeism will go down, this study should give them pause," Baicker said.
The study comes amid widespread interest in wellness programs.
The Kaiser Family Foundation's annual survey of employers found that 53% of small firms and 82% of large firms offer a program in at least one of these areas: smoking cessation, weight management and behavioral or lifestyle change. (Kaiser Health News is an editorially independent program of the foundation.)
Some programs are simple, offering gift cards or other small incentives to fill out a health risk assessment, take a lunch-and-learn class or join a gym or walking group. Others are far more invasive, asking employees to report on a variety of health-related questions and roll up their sleeves for blood tests.
A few employers tie financial incentives to workers actually lowering risk factors, such as high blood pressure or cholesterol — or making concerted efforts to participate in programs that might help them do so over time.
The Affordable Care Act allowed employers to offer financial incentives worth up to 30% of the cost of health insurance, leading some employers to offer what could be hundreds or even thousands of dollars off workers' deductibles or premiums to get them to participate. That led to court challenges about whether those programs are truly voluntary.
In the study reported in JAMA, the incentives were modest. Participants got small-dollar gift cards for taking wellness courses on topics such as nutrition, exercise, disease management and stress control. Total potential incentives averaged $250. About 35% of eligible employees at the 20 participating sites completed at least one module.
Results from those workers — including attendance and tenure data, their self-reported health assessment and results from lab blood tests — were specifically compared with similar reports from 20 primary comparison sites where workers were not offered the wellness gift cards and classes. Overall employment and health spending data from all worksites were included in the study.
Wellness program vendors said details matter when considering whether efforts will be successful.
Jim Pshock, founder and CEO of Bravo Wellness, said the incentives offered to BJ's workers might not have been large enough to spur the kinds of big changes needed to affect health outcomes.
Amounts of "of less than $400 generally incentivize things people were going to do anyway. It's simply too small to get them to do things they weren't already excited about," he said.
An accompanying editorialin JAMA noted that "traditional, broad-based programs like the one analyzed by Song and Baicker may lack the necessary intensity, duration, and focus on particular employee segments to generate significant effects over a short time horizon."
In other words, don't give up entirely on wellness efforts, but consider "more targeted approaches" that focus on specific workers with higher risks or on "health behaviors [that] may yield larger health and economic benefits," the editorial suggested.
It could be, the study acknowledges, that 18 months isn't enough time to track such savings. So, Baicker and Song also plan to publish three-year results once they are finalized.
Still, similar findings were recently reported in another randomized control trial conducted at the University of Illinois, where individuals were randomly selected to be offered wellness programs.
In one interesting point, that study found that wellness-program participants were likely already healthier and more motivated, "thus a primary benefit of these programs to employers may be their potential to attract and retain healthy workers with low medical spending."
Everyone involved in studying or conducting wellness agrees on one thing: Changing behavior — and getting people motivated to participate at all — can be difficult.
Steven Aldana, CEO of WellSteps, a wellness program vendor, said that for the efforts to be successful they must cut across many areas, from the food served in company cafeterias to including spouses or significant others to help people quit smoking, eat better or exercise more.
"Behavior is more complicated than simply taking a few wellness modules," said Aldana. "It's a lifestyle matrix or pattern you have to adopt."
Hospitals and nursing homes in California and Illinois are testing a surprisingly simple strategy against the dangerous, antibiotic-resistant superbugs that kill thousands of people each year: washing patients with a special soap.
The efforts — funded with roughly $8 million from the federal government's Centers for Disease Control and Prevention — are taking place at 50 facilities in those two states.
This novel approach recognizes that superbugs don't remain isolated in one hospital or nursing home but move quickly through a community, said Dr. John Jernigan, who directs the CDC's office on healthcare-acquired infection research.
"No healthcare facility is an island," Jernigan said. "We all are in this complicated network."
At least 2 million people in the U.S. become infected with an antibiotic-resistant bacterium each year, and about 23,000 die from those infections, according to the CDC.
People in hospitals are vulnerable to these bugs, and people in nursing homes are particularly vulnerable. Up to 15% of hospital patients and 65% of nursing home residents harbor drug-resistant organisms, though not all of them will develop an infection, said Dr. Susan Huang, who specializes in infectious diseases at the University of California-Irvine.
"Superbugs are scary and they are unabated," Huang said. "They don't go away."
Some of the most common bacteria in 'healthcare facilities are methicillin-resistant Staphylococcus aureus, or MRSA, and carbapenem-resistant Enterobacteriaceae, orCRE, often called "nightmare bacteria." E. coli and Klebsiella pneumoniae are two common germs that can fall into this category when they become resistant to last-resort antibiotics known as carbapenems. CRE bacteria cause an estimated 600 deaths each year, according to the CDC.
CREs have "basically spread widely" among healthcare facilities in the Chicago region, said Dr. Michael Lin, an infectious-diseases specialist at Rush University Medical Center, who is heading the CDC-funded effort there. "If MRSA is a superbug, this is the extreme — the super superbug."
Containing the dangerous bacteria has been a challenge for hospitals and nursing homes. As part of the CDC effort, doctors and healthcare workers in Chicago and Southern California are using the antimicrobial soap chlorhexidine, which has been shown to reduce infections when patients bathe with it. Though chlorhexidine is frequently used for bathing in hospital intensive care units and as a mouthwash for dental infections, it is used less commonly for bathing in nursing homes.
In Chicago, researchers are working with 14 nursing homes and long-term acute care hospitals, where staff are screening people for the CRE bacteria at admission and bathing them daily with chlorhexidine.
The Chicago project, which started in 2017 and ends in September, includes a campaign to promote handwashing and increased communication among hospitals about which patients carry the drug-resistant organisms.
The infection-control work was new to many nursing homes, which don't have the same resources as hospitals, Lin said.
In fact, three-quarters of nursing homes in the U.S. received citations for infection-control problems over a four-year period, according to a Kaiser Health News analysis, and the facilities with repeat citations almost never were fined. Nursing home residents often are sent back to hospitals because of infections.
In California, health officials are closely watching the CRE bacteria, which are less prevalent there than elsewhere in the country, and they are trying to prevent CRE from taking hold, said Dr. Matthew Zahn, medical director of epidemiology at the Orange County healthcare Agency. "We don't have an infinite amount of time," he said. "Taking a chance to try to make a difference in CRE's trajectory now is really important."
The CDC-funded project in California is based in Orange County, where 36 hospitals and nursing homes are using the antiseptic wash along with an iodine-based nose swab. The goal is to prevent new people from getting drug-resistant bacteria and keep the ones who already have the bacteria on their skin or elsewhere from developing infections, said Huang, who is leading the project.
Huang kicked off the project by studying how patients move among different hospitals and nursing homes in Orange County, and discovered they do so far more than imagined. That prompted a key question: "What can we do to not just protect our patients but to protect them when they start to move all over the place?" she recalled.
Her previous research showed that patients with the MRSA bacteria who used chlorhexidine for bathing and as a mouthwash, and swabbed their noses with a nasal antibiotic, could reduce their risk of developing a MRSA infection by 30%. But all the patients in that study, published in February in the New England Journal of Medicine, already had been discharged from hospitals.
Now the goal is to target patients still in hospitals or nursing homes and extend the work to CRE. The traditional hospitals participating in the new project are focusing on patients in intensive care units and those who already carried drug-resistant bacteria, while the nursing homes and the long-term acute care hospitals perform the cleaning — also called "decolonizing" — on every resident.
One recent morning at Coventry Court Health Center, a nursing home in Anaheim, Calif., 94-year-old Neva Shinkle sat patiently in her wheelchair. Licensed vocational nurse Joana Bartolome swabbed her nose and asked if she remembered what it did.
"It kills germs," Shinkle responded.
"That's right — it protects you from infection."
In a nearby room, senior project coordinator Raveena Singh from UC-Irvine talked with Caridad Coca, 71, who had recently arrived at the facility. She explained that Coca would bathe with the chlorhexidine rather than regular soap. "If you have some kind of open wound or cut, it helps protect you from getting an infection," Singh said. "And we are not just protecting you, one person. We protect everybody in the nursing home."
Coca said she had a cousin who had spent months in the hospital after getting MRSA. "Luckily, I've never had it," she said.
Coventry Court administrator Shaun Dahl said he was eager to participate because people were arriving at the nursing home carrying MRSA or other bugs. "They were sick there and they are sick here," Dahl said.
Results from the Chicago project are pending. Preliminary results of the Orange County project, which ends in May, show that it seems to be working, Huang said. After 18 months, researchers saw a 25% decline in drug-resistant organisms in nursing home residents, 34% in patients of long-term acute care hospitals and 9% in traditional hospital patients. The most dramatic drops were in CRE, though the number of patients with that type of bacteria was smaller.
The preliminary data also shows a promising ripple effect in facilities that aren't part of the effort, a sign that the project may be starting to make a difference in the county, said Zahn of the Orange County Healthcare Agency.
"In our community, we have seen an increase in antimicrobial-resistant infections," he said. "This offers an opportunity to intervene and bend the curve in the right direction."
Many presidential hopefuls, even official co-sponsors of Sanders' Medicare-for-All proposal, are at the same time edging toward a more incremental approach, called 'Medicare for America.'
As Democratic presidential primary candidates try to walk a political tightrope between the party's progressive and center-left wings, they face increasing pressure to outline the details of their health reform proposals.
On Wednesday, Sen. Bernie Sanders (I-Vt.) reaffirmed his stance by reintroducing a "Medicare-for-all" bill, the idea that fueled his 2016 presidential run.
As with its previous iterations, Sanders' latest bill would establish a national single-payer "Medicare" system with vastly expanded benefits, prohibit private plans from competing with Medicare and eliminate cost sharing. New in this version is a universal provision for long-term care in home and community settings (but Medicaid would continue to cover institutional care).
Already, it has an impressive list of Senate cosponsors — including Sanders' rivals for the Democratic presidential nomination, Cory Booker (D-N.J.), Kirsten Gillibrand (D-N.Y.), Kamala Harris (D-Calif.) and Elizabeth Warren (D-Mass.).
But many of the candidates — even official Medicare-for-all co-sponsors — are at the same time edging toward a more incremental approach, called "Medicare for America." Proponents argue it could deliver better health care to Americans while avoiding political, budgetary and legal objections.
It comes as politicians tread carefully over the political land mines a Medicare-for-all endorsement could unleash, while seeking to capitalize on a growing appetite for health reform.
During the 2018 midterm election campaigns, some congressional candidates talked about allowing people older than 55 to join Medicare, or allowing people younger than 65 to buy into it if they choose (the "public option"). Many aren't eager to face the industry opposition that a full-on Medicare expansion would surely trigger.
From the consumer perspective, sweeping reform poses a risk. Despite Medicare's popularity with its beneficiaries, the majority of Americans express satisfaction with their health care, and many are nervous about giving up private options. Also, many analysts are worried that a generous Medicare-for-all plan that promises everything would break the bank without any patient payments.
That tension is pushing a number of candidates toward an emerging option called "Medicare for America." The bill was introduced last December to little fanfare by two Democrats, Rep. Rosa DeLauro (Conn.) and Rep. Jan Schakowsky (Ill.). It hasn't been reintroduced in the new Congress.
This proposed system would guarantee universal coverage, but leaves job-based insurance available for those who want it. Unlike Medicare-for-all, though, it preserves premiums and deductibles, so beneficiaries would still have to pay some costs out-of-pocket. It allows private insurers to operate Medicare plans as well, a system called Medicare Advantage that covers about a third of the program's beneficiaries currently, and which would be outlawed under Medicare-for-all.
"Before policies get defined, what you see is people endorsing a plan that is a little, perhaps, less subject to early attack," said Celinda Lake, a Democratic pollster. "A lot of candidates feel if they endorse a plan that leaves some private insurance, they get more time to say what their ideas are about."
Medicare for America got its first high-profile endorsement from former Texas Rep. Beto O'Rourke, who launched his own 2020 bid in mid-March. Other candidates — including Warren, Gillibrand and Pete Buttigieg, the mayor of South Bend, Ind. — have tiptoed toward it without making any endorsements, suggesting they back Medicare-for-all in theory but also support a system that retains private insurance, at least temporarily.
Such an approach is perhaps unsurprising. Polling indicates voters want strong health reform. Candidates, election experts say, need something powerful to deliver.
Improving the Affordable Care Act, an idea backed by Sen. Amy Klobuchar, a Minnesota Democrat running in the primary's moderate lane, may not suffice.
"The ACA is popular at the 50 percent level, but it's not energetic. It doesn't get people who really like it," Blendon said. "What they're looking for is something that is exciting but isn't threatening."
Both Medicare-for-all and Medicare for America, experts noted, offer something that presidential candidates can campaign on and a health alternative that at first blush sounds appealing to many. But the latter could skirt some potential obstacles.
Approval for Medicare-for-all drops when people learn that, under such a program, they would likely lose their current health plan (even if the government-offered plan could theoretically provide more generous coverage).
The cost-sharing element of Medicare for America, meanwhile, would ostensibly quiet some of the concerns about paying for Medicare's expansion, though critics on the left worry it would mean some people would still be unable to afford care.
This also tracks with recent polling which suggests that, while Medicare-for-all support can be swayed, voters of all political stripes favor some sort of way to extend optional Medicare coverage, without necessarily eliminating the private industry altogether.
Employers would have to offer plans that were at least as generous as the government program, or direct employees to Medicare. Employers who stop offering health benefits would have to pay a Medicare payroll tax.
For now, most candidates are still avoiding a concrete stance on Medicare for America. Despite signs of interest, the Buttigieg, Gillibrand and Warren campaigns all declined to directly answer questions about whether they endorse Medicare for America. The campaigns of other candidates in the race — Harris, Klobuchar, Booker, former Housing and Urban Development Secretary Julian Castro and Washington Gov. Jay Inslee — similarly declined to comment.
Reading between the lines, though, their promises to achieve universal health care by expanding Medicare — while retaining private insurance — leaves them few options besides something like Medicare for America, argued one of its main architects.
"There are variations besides this particular plan, but once you start to actually dig into this, if you want universal coverage you're going to have to do the kinds of things" spelled out in Medicare for America, argued Jacob Hacker, a political scientist at Yale University, who played a lead role in devising this proposal.
Still, though, it has prompted objections from both the left and the right.
On the far left, the cost sharing is a dominant concern. (Under Medicare for America, an individual would have a $3,500 out-of-pocket limit; a family would have a $5,000 limit. Premiums would be capped at almost 10% of a household's income.) Those critics also say the plan's accommodations to private insurance limit the government's ability to negotiate lower prices.
Conservatives repeat many of the arguments levied against Medicare-for-all — too expensive, too disruptive.
Hospitals, insurance, drugmakers and doctors, who have already mobilized against Medicare-for-all, also can be expected to make just as strong a showing against Medicare for America, political analysts said. More Medicare means less revenue for the medical industry.
Said David Blumenthal of the Commonwealth Fund: "The fact of expanded Medicare will be the focus of attacks."
The CVS Caremark plan wasn't popular with customers, and CVS Health, which owns CVS Caremark, was quick to point this out as evidence that consumers prefer the current rebate system.
This article was first published on Tuesday, April 4, 2019, inKaiser Health News.
Unraveling how much of a prescription drug price gets swallowed by "middlemen" is at the forefront of Tuesday's drug price hearing in the Senate. One thing bound to come up: rebates.
Both major political parties have shown interest in remedying high drug prices, and drugmakers have bemoaned how rebates to middlemen keep them from reaping every dollar associated with those price tags.
Pharmacy giant CVS Health criticized the Trump administration's proposal to end these post-transaction discounts as they apply to Medicare. Yet, in January the company rolled out a Medicare drug plan that experts say is similar "in spirit" to the administration's proposal.
The CVS Caremark plan wasn't popular with customers, and CVS Health, which owns CVS Caremark, was quick to point this out as evidence that consumers prefer the current rebate system.
"We had a very, I would say, small number of seniors enroll in that program," Larry Merlo, CVS Health's CEO said on a February earnings call with investors. "And we think one of the barriers to that was the increase that we saw in the monthly premium."
The CVS plan's premium was $80 a month, which is about doublethe average Medicare Part D monthly charge. But since it is designed to pass on a portion of rebates directly to patients at the pharmacy counter, certain patients would wind up with smaller out-of-pocket costs than they previously paid.
"Even very well-informed consumers would not necessarily understand that a higher premium plan in this case means that they're incurring smaller amounts at the point of sale," said Rachel Sachs, an associate law professor at Washington University in St. Louis who specializes in healthcare.
So why did only 25,000 people sign up for the plan, called SilverScript Allure? Either consumers didn't want the plan or perhaps they just didn't understand it?
We'll break it down for you.
Untangling Jargon: The Way Things Are And How They Could Change
A pharmacy benefit manager, or PBM, handles drug claims for health insurance companies. The big ones are Express Scripts, CVS Caremark and OptumRx. Every time you fill a prescription and use your drug plan, your PBM is involved in paying the claim and determining how much money you owe the cashier.
A rebate is a discount the PBM negotiates with a drug manufacturer off the price the drugmaker sets, which is called a list price. Rebates are not made public, and they typically don't get passed on to the patient at the pharmacy counter in the form of a lower copayment, experts say.
When the drugmaker eventually pays the rebate back to the PBM, the PBM often uses this money to lower premiums, which are the monthly fees that Medicare Part D plans charge beneficiaries. They differ for each drug plan.
In a way, patients taking drugs with high list prices and big rebates wind up subsidizing other patients' premiums, said Erin Trish, the associate director of the University of Southern California Schaeffer Center for Health Policy and Economics. Premiums on average haven't substantially increased in more than a decade, but it may be "unfair" to the patients paying higher prices for drugs at the pharmacy counter.
"Some may argue, 'They're sicker… Maybe they should [pay more],'" Trish said. "Look. We decided everyone should pay the same premium in this market. [Rebates] shouldn't be a roundabout way to make a subset of beneficiaries pay more."
That could all change under a new Trump administration proposal that would ban rebates as they exist today. The negotiated discounts would be applied at the pharmacy counter, meaning discounts would be passed on to patients as out-of-pocket costs that are calculated based on the discounted price, not the higher list price.
For patients taking drugs with high list prices and large rebates, like insulin, it could mean noticeable savings, Sachs said. For patients taking drugs without big rebates, like generics or brand-name drugs without other branded competition, they're not likely to see much change at the pharmacy counter.
Everyone, however, will see premiums go up. It's unclear yet how much, but Trish said the SilverScript Allure plan CVS Caremark is offering isn't necessarily the best indicator. Consultants hired by the Department of Health and Human Services estimatedpremiums will go up $3.20 to $5.64 per month if the rule takes effect in 2020.
The average Medicare Part D premium for 2019 was $41.21, according to the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)
So Why Didn't Patients Want The CVS Caremark Plan?
It's not clear how well seniors shopping for drug plans understood the SilverScript Allure plan, among their many options. They could see it had a high premium, but no deductible. They might not have realized it required smaller payments on drugs at the pharmacy counter.
Research shows that the premium is the most important factor seniors consider when choosing a plan, Sachs said.
On top of that, people are unlikely to leave their current plans even if there's a better one available.
What's more, we don't know how well CVS Caremark marketed the plan to seniors who would benefit. They wouldn't tell us, despite multiple calls and emails.
OptumRx, a competing PBM, started offering customers similar discounts at the pharmacy counter — but for people with commercial insurance, not Medicare or Medicaid. Unlike CVS Caremark, it has a web page with basic language, like "point of sale discounts mean lower costs," and a link to request more information about switching. OptumRx did not respond to a request for comment.
PBMs: Helping Or Hurting?
Rebates for individual plans and drugs are confidential, but in Medicare Part D, they've increased on average from 9.6% of total spending in 2007 to 19.9% in 2016, according to annual reports to the Medicare boards of trustees.
So it's perhaps unsurprising the brand-name drug trade group, the Pharmaceutical Research and Manufacturers of America, said it "applaud[s]" the proposal to overhaul the rebate system. PhRMA says it pushes them to raise prices in order to offer larger rebates, because drugs with larger rebates often get preferential treatment by PBMs.
Still, PBMs offer the benefit of batting down net prices (the price after rebate), and keeping down drug spending overall.
There are multiple estimates on how much the rebate proposal would cost the Centers for Medicare & Medicaid if it took effect, and they indicate that unless there are other changes to Medicare Part D, it would likely cost more money than the current system, Sachs said.
"It is startling to see the administration moving forward so rapidly with this proposal without a better understanding of how different actors might respond," she said. As a result, there's a "huge amount of uncertainty" over how this could all play out.
Parents have found end runs around the new law requiring vaccinations. And they have done so, often, with the cooperation of doctors — some not even pediatricians.
This article was first published on Friday, April 5, 2019 inKaiser Health News.
SAN JOSE, Calif. — At two public charter schools in the Sonoma wine country town of Sebastopol, more than half the kindergartners received medical exemptions from state-required vaccines last school year. The cities of Berkeley, Santa Cruz, Nevada City, Arcata and Sausalito all had schools in which more than 30% of the kindergartners had been granted such medical exemptions.
Nearly three years ago, with infectious disease rates ticking up, California enacted a fiercely contested lawbarring parents from citing personal or religious beliefs to avoid vaccinating their children. Children could be exempted only on medical grounds, if the shots were harmful to health.
Yet today, many of the schools that had the highest rates of unvaccinated students before the new measure continue to hold that alarming distinction. That's because parents have found end runs around the new law requiring vaccinations. And they have done so, often, with the cooperation of doctors — some not even pediatricians. One prolific exemption provider is a psychiatrist who runs an anti-aging clinic.
Doctors in California have broad authority to grant medical exemptions to vaccination, and to decide the grounds for doing so. Some are wielding that power liberally and sometimes for cash: signing dozens — even hundreds — of exemptions for children in far-off communities.
"It's sort of the Hail Mary of the vaccine refusers who are trying to circumvent SB 277," the California Senate bill signed into law by Gov. Jerry Brown in 2015, said Dr. Brian Prystowsky, a Santa Rosa pediatrician. "It's really scary stuff. We have pockets in our community that are just waiting for measles to rip through their schools."
The number of California children granted medical exemptions from vaccinations has tripled in the past two years.
Across the nation, 2019 is shaping up to be one of the worst years for U.S. measles cases in a quarter-century, with major outbreaks in New York, Texas and Washington state, and new cases reported in 12 more states, including California. California's experience underlines how hard it is to get parents to comply with vaccination laws meant to protect public safety when a small but adamant population of families and physicians seems determined to resist.
When Senate Bill 277 took effect in 2016, California became the third state, after Mississippi and West Virginia, to ban vaccine exemptions based on personal or religious beliefs for public and private school students. (The ban does not apply to students who are home-schooled.)
In the two subsequent years, SB 277 improved overall child vaccination rates: The percentage of fully vaccinated kindergartners rose from 92.9% in the 2015-16 school year to 95.1% in 2017-18.
But those gains stalled last year due to the dramatic rise in medical exemptions: More than 4,000 kindergartners received these exemptions in the 2017-18 school year. Though the number is still relatively small, many are concentrated in a handful of schools, leaving those classrooms extremely vulnerable to serious outbreaks.
Based on widely accepted federal guidelines, vaccine exemptions for medical reasons should be exceedingly rare. They're typically reserved for children who are allergic to vaccine components, who have had a previous reaction to a vaccine, or whose immune systems are compromised, including kids being treated for cancer. Run-of-the-mill allergies and asthma aren't reasons to delay or avoid vaccines, according to the U.S. Centers for Disease Control and Prevention. Neither is autism.
Before California's immunization law took effect, just a fraction of 1% of the state's schoolchildren had medical exemptions. By last school year, 105 schools, scattered across the state, reported that 10% or more of their kindergartners had been granted medical exemptions. In 31 of those schools, 20% or more of the kindergartners had medical exemptions.
Seesawing Exemptions
As of July 2016, California no longer allows parents to exempt their children from state-required vaccinations based on personal beliefs. Many of the same schools that once had the highest percentage of students with personal belief exemptions now lead the state in student medical exemptions.
The spike in medical exemptions is taking place amid a politically tinged, often rancorous national conversation over vaccines and personal liberty as measles resurges in the U.S. and worldwide. At least 387 cases of measles had beenreported nationwide through March 28, according to the CDC. In California, 16 cases had been reported, two of them requiring hospitalization.
The problem in California, state officials say, is how the immunization law was structured. It removed the ability of parents to cite "personal belief" as a reason for exempting their children from vaccine requirements in day care and schools. Exemptions now must be authorized by a licensed physician who provides a written statement citing a medical condition that indicates immunization "is not considered safe."
But the law does not specify the conditions that qualify a student for a medical exemption, nor does it require physicians to follow federal guidelines.
The wording has led to a kind of gray market in which parents share names of "vaccine-friendly" doctors by word of mouth or in closed Facebook groups. And some of those doctors are granting children blanket exemptions — for all time and all vaccines — citing a range of conditions not supported by federal guidelines, such as a family history of eczema or arthritis.
Amid growing concerns about suspect exemptions, the California Department of Public Health recently launched a review of schools with "biologically unlikely" numbers of medical exemptions, said the agency's director, Dr. Karen Smith. Doctors who have written questionable exemptions will be referred to the Medical Board of California for possible investigation.
The medical board, which licenses doctors, has the authority to levy sanctions if physicians have not followed standard medical practice in examining patients or documenting specific reasons for an exemption.
In recent years, however, the board has sanctioned only one doctor for inappropriately writing a medical vaccine exemption in a case that made headlines. Since 2013, the board has received 106 complaints about potentially improper vaccine exemptions, including nine so far this year, said spokesman Carlos Villatoro.
One pending case involves Dr. Ron Kennedy, who was trained as a psychiatrist and now runs an anti-aging clinic in Santa Rosa.
Medical board investigators took the unusual step of subpoenaing 12 school districts for student medical records after receiving complaints that Kennedy was writing inappropriate exemptions. They found that Kennedy had written at least 50 exemptions, using nearly identical form letters, for students in multiple communities, including Santa Rosa, Fremont and Fort Bragg, saying that immunizations were "contraindicated" for a catchall list of conditions including lupus, learning disability, food allergies and "detoxification impairment."
Dr. Dean Blumberg, chief of pediatric infectious diseases at UC Davis Children's Hospital and the medical board's expert witness, said that the exemptions issued by Kennedy appear to have been provided "without an appropriate evaluation," according to court documents.
Kennedy has refused to respond to the board's subpoenas seeking the medical records of three of his patients, according to court documents. The board has yet to file a formal accusation against Kennedy, and he continues to practice.
Like Kennedy, many of the doctors granting unorthodox exemptions cite their belief in parental rights or reference concerns not supported by conventional medical science. Kennedy is suing the medical board and its parent agency, the California Department of Consumer Affairs, saying the state did not have the legal right to subpoena school districts for his patients' medical records without first informing him so he could challenge the action in court. The case is ongoing.
Kennedy declined comment to Kaiser Health News. "I don't want to be out in the open," he said in a brief phone exchange. "I've got to go. I've got a business to run."
In Monterey, Dr. Douglas Hulstedt is known as the doctor to see for families seeking medical exemptions. In a brief phone interview, he said he was worried about being targeted by the state medical board. "I have stuck my neck way out there just talking with you," he said. Hulstedt does not give exemptions to every child he examines, he said, but does believe vaccines can cause autism — a fringe viewpoint that has been debunked by multiple studies.
In March, the online publication Voice of San Diego highlighted doctors who write medical exemptions, including one physician who had written more than a third of the 486 student medical exemptions in the San Diego Unified School District. District officials had compiled a list of such exemptions and the doctors who provided them.
State Sen. Richard Pan (D-Sacramento), a pediatrician who sponsored California's vaccine law, has been a vocal critic of doctors he says are skirting the intent of the legislation by handing out "fake" exemptions. Last month, he introduced follow-up legislation that would require the state health department to sign off on medical exemptions. The department also would have the authority to revoke exemptions found to be inconsistent with CDC guidelines.
"We cannot allow a small number of unethical physicians to put our children back at risk," Pan said. "It's time to stop fake medical exemptions and the doctors who are selling them."
California Healthline digital reporter Harriet Blair Rowan and California politics correspondent Samantha Young contributed to this report.
As California hospitals contend with the dramatic growth in homeless patients, a new state law requires them to provide homeless patients a meal, clothes and vaccine screenings before discharge.
This article was first published on Wednesday, April 3, 2019 inKaiser Health News.
SAN JOSE, Calif. — After they amputated the second toe on John Trumbla's right foot last summer, doctors sent him to a nursing home because he still needed medical care — but not necessarily a hospital bed.
The proud, burly Army veteran resisted at first, but he didn't have a choice. Before his hospitalization at Santa Clara Valley Medical Center, Trumbla, 56, and his wife had been homeless, crashing in his boss's construction shop or living out of their station wagon.
Trumbla spent six months at the nursing home, Skyline Healthcare Center, while social workers sought housing vouchers and scouted rental leads. But nothing panned out. When he finally left Skyline in mid-February, he stayed at a motel for a night before heading back to his boss's shop.
"We might just have to leave this area. I don't want to, but I also don't want to live on the streets," Trumbla said from his bed at Skyline in early February, citing the San Francisco Bay Area's astronomical rents.
Skyline allocates 15 beds to the Santa Clara hospital for patients who are homeless or have no one to care for them at home. It's part of a year-old partnership born of necessity. Santa Clara Valley Medical Center, like many other hospitals in the state, has struggled to find suitable accommodations for a growing number of homeless patients who need follow-up medical attention after they're discharged, said Dr. Raymond Chan, co-director of the hospital's program at Skyline.
In Santa Clara County, the number of homeless patient discharges from hospitals jumped 42% from 2015 to 2017, according to data from the Office of Statewide Health Planning and Development.
Statewide, hospitals discharged homeless patients nearly 100,000 times in 2017, a 28% increase over 2015. The discharges include 2,608 deaths in hospitals from 2015 to 2017.
As hospitals contend with the dramatic growth in homeless patients, they must comply witha new state law, implemented in January, which requires them to provide homeless patients a meal, clothes and vaccine screenings before discharging them.
Hospitals also must try to find the patients a bed at a safe destination, offer them transportation there and document the steps they have taken to do so.
If a hospital cannot find a bed for a patient, or if the patient refuses help, he can go to a location of his choice, including back to the streets.
The requirements expand on July 1. Starting then, hospitals will have to keep a log of the homeless patients they discharge and where they go, among other mandates.
Legislators passed the law in response to reports that hospitals were dumping homeless patients on the streets with little more than their hospital gowns. One Sacramento woman who had undergone a double mastectomy was sent to a Salvation Army shelter after her discharge, only to find there were no available beds. She had to sleep in her car, The Sacramento Bee reported.
Several California hospitals have settled lawsuits in response to such allegations.
But finding a suitable place for each patient isn't as easy as calling a shelter and securing a cot. There simply aren't enough places — or, in some cases, the right places — to send these individuals, hospitals say.
Some patients need more follow-up care and monitoring than might be available in a basic shelter.
"We knew that the challenge for our hospitals would be what to do with patients who require services when there are few programs, spaces and beds available for post-acute care," said Peggy Wheeler, vice president of rural health at the California Hospital Association, which initially opposed the legislation.
If appropriate settings aren't available for homeless patients who need to heal from a wound or require follow-up treatment, some of them may stay in the hospital longer than necessary, Wheeler said.
"This puts hospitals in a situation where they don't have a bed available for someone who does need acute care," she said.
Homeless patients with complex medical needs are especially difficult to place in rural communities because of a lack of adequate services, said Brenda Robertson, care management regional director for Adventist Health hospitals in central California.
"Most shelters will not accept a patient on oxygen, and a subset of younger, aggressive behavioral health patients are not appropriate to be placed in a skilled nursing facility amongst frail elders," Robertson said.
Many of these patients need transitional care where they can rest and recover before being on their own again, she said. "But in central California there really isn't much."
Bigger cities have more resources — but also more homeless patients.
Last year, the nonprofit National Health Foundation opened a 62-bed facility in downtown Los Angeles for discharged hospital patients who need less intensive medical oversight than a nursing home provides. Patients at that facility have access to case managers who arrange for transportation and food, and try to find them permanent housing.
Area hospitals often reserve beds at the facility for discharged homeless patients, said Jennifer Bayer, vice president of external affairs at the Hospital Association of Southern California. At least one health plan also leases beds there for its enrollees.
During that period, Skyline discharged 42 of the patients, the majority into long-term housing programs or to family members and friends, said Ngo. Of those, six were readmitted to the hospital — a low number for this population, Ngo said.
That was encouraging, he said, but "we know 15 beds don't even begin to meet the needs" of the homeless population in Santa Clara County.
Thehomeless count in 2017 showed 7,394 homeless people in the county, with the majority in San Jose.
A month after his discharge, Trumbla still lives in his boss's shop. But his toe has healed, and he credits the six months at the nursing home for helping him control his diabetes. He planned to start working again in construction this month.
But his wife, Manda Upham, is now in a hospital because of chronic obstructive pulmonary disease and congestive heart failure, Trumbla said. It's possible she might be transferred to a hospital outside of San Jose.
"More hospitals and no housing in sight yet," Trumbla lamented. "It's getting complicated again."
Hospitals say they're providing options to patients who have exhausted standard treatments. But critics suggest the hospitals are exploiting desperate patients and profiting from trendy but unproven treatments.
The online video seems to promise everything an arthritis patient could want.
The six-minute segment mimics a morning talk show, using a polished TV host to interview guests around a coffee table. Dr. Adam Pourcho extols the benefits of stem cells and "regenerative medicine" for healing joints without surgery. Pourcho, a sports medicine specialist, says he has used platelet injections to treat his own knee pain, as well as a tendon injury in his elbow. Extending his arm, he says, "It's completely healed."
Brendan Hyland, a gym teacher and track coach, describes withstanding intense heel pain for 18 months before seeing Pourcho. Four months after the injections, he says, he was pain-free and has since gone on a 40-mile hike.
"I don't have any pain that stops me from doing anything I want," Hyland says.
The video's cheerleading tone mimics the infomercials used to promote stem cell clinics, several of which have recently gotten into hot water with federal regulators, said Dr. Paul Knoepfler, a professor of cell biology and human anatomy at the University of California-Davis School of Medicine. But the marketing video wasn't filmed by a little-known operator.
It was sponsored by Swedish Medical Center, the largest nonprofit health provider in the Seattle area.
Hospitals say they're providing options to patients who have exhausted standard treatments. But critics suggest the hospitals are exploiting desperate patients and profiting from trendy but unproven treatments.
The Food and Drug Administration is attempting to shut down clinics that hawk unapproved stem cell therapies, which have been linked to several cases of blindness and at least 12 serious infections. Although doctors usually need preapproval to treat patients with human cells, the FDA has carved out a handful of exceptions, as long as the cells meet certain criteria, said Barbara Binzak Blumenfeld, an attorney who specializes in food and drug law at Buchanan Ingersoll & Rooney in Washington.
Hospitals like Mayo are careful to follow these criteria, to avoid running afoul of the FDA, said Dr. Shane Shapiro, program director for the Regenerative Medicine Therapeutics Suites at Mayo Clinic's campus in Florida.
'Expensive Placebos'
While hospital-based stem cell treatments may be legal, there's no strong evidence they work, said Leigh Turner, an associate professor at the University of Minnesota's Center for Bioethics who has published a series of articles describing the size and dynamics of the stem cell market.
"FDA approval isn't needed and physicians can claim they aren't violating federal regulations," Turner said. "But just because something is legal doesn't make it ethical."
For doctors and hospitals, stem cells are easy money, Turner said. Patients typically pay more than $700 a treatment for platelets and up to $5,000 for fat and bone marrow injections. As a bonus, doctors don't have to wrangle with insurance companies, which view the procedures as experimental and largely don't cover them.
"It's an out-of-pocket, cash-on-the-barrel economy," Turner said. Across the country, "clinicians at elite medical facilities are lining their pockets by providing expensive placebos."
Some patient advocates worry that hospitals are more interested in capturing a slice of the stem-cell market than in proving their treatments actually work.
"It's lucrative. It's easy to do. All these reputable institutions, they don't want to miss out on the business," said Dr. James Rickert, president of the Society for Patient Centered Orthopedics, which advocates for high-quality care. "It preys on people's desperation."
In a joint statement, Pourcho and Swedish defended the online video.
"The terminology was kept simple and with analogies that the lay person would understand," according to the statement. "As with any treatment that we provide, we encourage patients to research and consider all potential treatment options before deciding on what is best for them."
But Knoepfler said the guests on the video make several "unbelievable" claims.
At one point, Dr. Pourcho says that platelets release growth factors that tell the brain which types of stem cells to send to the site of an injury. According to Pourcho, these instructions make sure that tissues are repaired with the appropriate type of cell, and "so you don't get, say, eyeball in your hand."
Knoepfler, who has studied stem cell biology for two decades, said he has never heard of "any possibility of growing eyeball or other random tissues in your hand." Knoepfler, who wrote about the video in February on his blog, The Niche, said, "There's no way that the adult brain could send that kind of stem cells anywhere in the body."
The marketing video debuted in July on KING-TV, a Seattle station, as part of a local lifestyles show called "New Day Northwest." Although much of the show is produced by the KING 5 news team, some segments — like Pourcho's interview — are sponsored by local advertisers, said Jim Rose, president and general manager of KING 5 Media Group.
After being contacted by KHN, Rose asked Swedish to remove the video from YouTube because it wasn't labeled as sponsored content. Omitting that label could allow the video to be confused with news programming. The video now appears only on the KING-TV website, where Swedish is labeled as the sponsor.
"The goal is to clearly inform viewers of paid content so they can distinguish editorial and news content from paid material," Rose said. "We value the public's trust."
Increasing Scrutiny
Federal authorities have recently begun cracking down on doctors who make unproven claims or sell unapproved stem cell products.
In October, the Federal Trade Commission fined stem cell clinics millions of dollars for deceptive advertising, noting that the companies claimed to be able to treat or cure autism, Parkinson's disease and other serious diseases.
In a recent interview Scott Gottlieb, the FDA commissioner, said the agency will continue to go after what he called "bad actors."
With more than 700 stem cell clinics in operation, the FDA is first targeting those posing the biggest threat, such as doctors who inject stem cells directly into the eye or brain.
"There are clearly bad actors who are well over the line and who are creating significant risks for patients," Gottlieb said.
Gottlieb, set to leave office April 5, said he's also concerned about the financial exploitation of patients in pain.
"There's economic harm here, where products are being promoted that aren't providing any proven benefits and where patients are paying out-of-pocket," Gottlieb said.
Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said there is a broad "spectrum" of stem cell providers, ranging from university scientists leading rigorous clinical trials to doctors who promise stem cells are "for just about anything." Hospitals operate somewhere in the middle, Marks said.
"The good news is that they're somewhat closer to the most rigorous academics," he said.
The Mayo Clinic's regenerative medicine program, for example, focuses conditions such as arthritis, where injections pose few serious risks, even if that's not yet the standard of care, Shapiro said.
Rickert said it's easy to see why hospitals are eager to get in the game.
The market for arthritis treatment is huge and growing. At least 30 million Americans have the most common form of arthritis, with diagnoses expected to soar as the population ages. Platelet injections for arthritis generated more than $93 million in revenue in 2015, according to an article last year in The Journal of Knee Surgery.
"We have patients in our offices demanding these treatments," Shapiro said. "If they don't get them from us, they will get them somewhere else."
Doctors at the Mayo Clinic try to provide stem cell treatments and similar therapies responsibly, Shapiro said. In a paper published this year, Shapiro described the hospital's consultation service, in which doctors explain patients' options and clear up misconceptions about what stem cells and other injections can do. Doctors can refer patients to treatment or clinical trials.
"Most of the patients do not get a regenerative [stem cell] procedure," Shapiro said. "They don't get it because after we have a frank conversation, they decide, 'Maybe it's not for me.'"
Lots Of Hype, Little Proof
Although some hospitals boast of high success rates for their stem cell procedures, published research often paints a different story.
The Mayo Clinic website says that 40 to 70% of patients "find some level of pain relief." Atlanta-based Emory Healthcare claims that 75 to 80% of patients "have had significant pain relief and improved function." In the Swedish video, Pourcho claims "we can treat really any tendon or any joint" with PRP.
The strongest evidence for PRP is in pain relief for arthritic knees and tennis elbow, where it appears to be safe and perhaps helpful, said Dr. Nicolas Piuzzi, an orthopedic surgeon at the Cleveland Clinic.
But PRP hasn't been proven to help every part of the body, he said.
PRP has been linked to serious complications when injected to treat patellar tendinitis, an injury to the tendon connecting the kneecap to the shinbone. In a 2013 paper, researchers described the cases of three patients whose pain got dramatically worse after PRP injections. One patient lost bone and underwent surgery to repair the damage.
"People will say, 'If you inject PRP, you will return to sports faster,'" said Dr. Freddie Fu, chairman of orthopedic surgery at the University of Pittsburgh Medical Center. "But that hasn't been proven."
"PRP is sort of a 'buyer beware' situation," said Dr. William Li, president and CEO of the Angiogenesis Foundation, whose research focuses on blood vessel formation. "It's the poor man's approach to biotechnology."
Tests of other stem cell injections also have failed to live up to expectations.
Shapiro published a rigorously designed study last year in Cartilage, a medical journal, that found bone marrow injections were no better at relieving knee pain than saltwater injections. Rickert noted that patients who are in pain often get relief from placebos. The more invasive the procedure, the stronger the placebo effect, he said, perhaps because patients become invested in the idea that an intervention will really help. Even saltwater injections help 70% of patients, Fu said.
A 2016 review in the Journal of Bone and Joint Surgery concluded that "the value and effective use of cell therapy in orthopaedics remain unclear." The following year, a review in the British Journal of Sports Medicine concluded, "We do not recommend stem cell therapy" for knee arthritis.
Shapiro said hospitals and health plans are right to be cautious.
"The insurance companies don't pay for fat grafting or bone-marrow aspiration, and rightly so," Shapiro said. "That's because we don't have enough evidence."
Rickert, an orthopedist in Bedford, Ind., said fat, bone marrow and platelet injections should be offered only through clinical trials, which carefully evaluate experimental treatments. Patients shouldn't be charged for these services until they've been tested and shown to work.
Orthopedists — surgeons who specialize in bones and muscles — have a history of performing unproven procedures, including spinal fusion, surgery for rotator cuff disease and arthroscopy for worn-out knees, Turner said. Recently, studies have shown them to be no more effective than placebos.
Misleading Marketing
Some argue that joint injections shouldn't be marketed as stem cell treatments at all.
Piuzzi said he prefers to call the injections "orthobiologics,"noting that platelets are not even cells, let alone stem cells. The number of stem cells in fat and bone marrow injections is extremely small, he said. In fat tissue, only about 1 in 2,000 cells is a stem cell, according to a March paper in The Bone & Joint Journal. Stem cells are even rarer in bone marrow, where 1 in 10,000 to 20,000 cells is a stem cell.
Patients are attracted to regenerative medicine because they assume it will regrow their lost cartilage, Piuzzi said. There's no solid evidence that the commercial injections used today spur tissue growth, Piuzzi said. Although doctors hope that platelets will release anti-inflammatory substances, which could theoretically help calm an inflamed joint, they don't know why some patients who receive platelet injections feel better, but others don't.
So, it comes as no surprise that many patients have trouble sorting through the hype.
Florida resident Kathy Walsh, 61, said she wasted nearly $10,000 on stem cell and platelet injections at a Miami clinic, hoping to avoid knee replacement surgery.
When Walsh heard about a doctor in Miami claiming to regenerate knee cartilage with stem cells, "it seemed like an answer to a prayer," said Walsh, of Stuart, Fla. "You're so much in pain and so frustrated that you cling to every bit of hope you can get, even if it does cost you a lot of money."
The injections eased her pain for only a few months. Eventually, she had both knees replaced. She has been nearly pain-free ever since. "My only regret," she said, "is that I wasted so much time and money."