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 in Kaiser Health News.

By Barbara Feder Ostrov

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 law barring 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 been reported 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.

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Barbara Feder Ostrov: barbarao@kff.org, @barbfederostrov

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.

This article was first published April 2, 2019, by Kaiser Health News.

By Liz Szabo, Kaiser Health News

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.

Swedish is one of a growing number of respected hospitals and health systems — including the Mayo Clinic, the Cleveland Clinic and the University of Miami — that have entered the lucrative business of stem cells and related therapies, including platelet injections. Typical treatments involve injecting patients' joints with their own fat or bone marrow cells, or with extracts of platelets, the cell fragments known for their role in clotting blood. Many patients seek out regenerative medicine to stave off surgery, even though the evidence supporting these experimental therapies is thin at best, Knoepfler said.

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."

A 2017 study of PRP found it relieved knee pain slightly better than injections of hyaluronic acid. But that's nothing to brag about, Rickert said, given that hyaluronic acid therapy doesn't work, either. While some PRP studies have shown more positive results, Rickert notes that most were so small or poorly designed that their results aren't reliable.

In its 2013 guidelines for knee arthritis, the American Academy of Orthopaedic Surgeons said it is "unable to recommend for or against" PRP.

"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."

The Missouri Hospital Association called on state Medicaid officials to investigate findings about children covered by the state-federal program for low-income families.

This article was first published Monday, April 1, 2019 in Kaiser Health News.

By Phil Galewitz

After more than 2,000 Missouri children diagnosed with mental illness were shifted from traditional Medicaid into three for-profit managed-care companies, the state's hospitals noticed an alarming trend: a doubling in the percentage who had thoughts of suicide or attempted suicide.

Additionally, the average length of stay for these children in psychiatric hospitals dropped from 10 days to seven following the Medicaid change in May 2017, according to a study released this month by the Missouri Hospital Association.

The hospital association called on state Medicaid officials to investigate the study's findings about children covered by the state-federal program for low-income families. The group acknowledged that factors other than the move to managed care could have played a role behind the increase, including social media, cyberbullying and lack of access to specialized mental health care.

While children with suicidal thoughts are at higher risk of suicide, the hospital association said it had no evidence that more children were taking their own lives after the move to managed care.

The growing number of suicides among children and youths has prompted national concern. The suicide rate in Missouri has doubled from 2.8 per 100,000 children in 2003 to 6.4 per 100,000 children in 2017, according to the hospital association. In that same time period, 735 Missouri children died by suicide.

The Missouri Health Plan Association, which represents the three Medicaid managed-care plans in the state, slammed the report. "This study is not peer-reviewed, it is based on a very small sample size and was clearly commissioned to attempt to further a predetermined hypothesis," the group said in a statement.

Despite finding the study "fundamentally flawed," the health plan association added that it was taking the findings "very seriously."

Joan Alker, director of the Georgetown University Center for Children and Families, called the Missouri report "extremely troubling." She said the new data set doesn't prove managed care has caused any problem but does raise questions over whether children are getting adequate treatment.

"Managed care is an effort to save money and that is done by getting rid of unnecessary care or coordinating care better, but a lot of managed-care organizations cut corners," she said.

Missouri's top Medicaid official said he was aware that youth suicides had increased in the state since 2003, but he reacted cautiously to the report's implied connection to the growing use of managed care since 2017. Missouri Medicaid shifted to managed care in the more populous areas of the state around St. Louis and Kansas City nearly a decade ago.

"We welcome collaborative conversations on how to address these problems, but cannot let those conversations devolve into finger pointing," Missouri Medicaid Director Todd Richardson said in a statement. More research is needed into other factors, he said, such as access to follow-up care, medication compliance and differences in outcomes at facilities around the state.

Angela Kimball, national director of advocacy and public policy at the National Alliance on Mental Illness, said Medicaid managed care can be helpful in coordinating treatments and providing special services such as team-based care. But it can also "mean denying access to care or not approving services that are needed."

Managed care works best when states provide strong oversight and clarity about the health plans' goals, she said.

Kimball said that the move to managed care could play a role in more children acknowledging suicidal thoughts or attempts, but that greater awareness of mental health conditions and of suicide could factor in.

The study looked at the impact of the state's shift of 160,000 low-income children living in 61 mostly rural counties from traditional fee-for-service Medicaid to managed care in 2017.

That included 2,152 children ages 5 to 19 who received inpatient mental health services before and after the switch to managed care. The study used hospital insurance claims data for the 18 months before the shift and 19 months after.

When these children were getting coverage through traditional Medicaid, about 10 percent had suicidal thoughts or made a suicide attempt in the 90 days after being discharged from an inpatient psychiatric hospital. That figure rose to nearly 19 percent after the move to managed care.

A similar increase was found analyzing children both 30 days and 60 days after discharge, according to the study.

Paul Gionfriddo, CEO of Mental Health America, a nonprofit that advocates for better care, said if managed care was working it would be making children healthier — meaning children with mental health issues would be less likely to think about suicide or attempt it.

"If this was my state where I was a public policy maker, I would be very nervous and concerned and open a public inquiry to examine what is happening," said Gionfriddo, a former Connecticut state lawmaker.

Missouri hospitals and psychiatrists for years have speculated that the state's move to require Medicaid enrollees to get coverage through private managed-care plans reduced their access to mental health services.

That's because many private health plans have tightened the criteria for patients seeking inpatient care or reduced the length of their admission.

Alyson Wysong-Harder, a co-author of the study, called the data shocking. She is the CEO of Heartland Behavioral Health Services, a psychiatric facility in Nevada, Mo., which treats children and is about 90 miles south of Kansas City.

"We get these kids readmitted on a regular basis," she said. "These are very vulnerable patients."

Wysong-Harder said the lack of child psychiatrists in many communities means it's vital that children get adequate time in the hospital to deal with their mental illness.

"They have this one opportunity often to get this critical care and to get their medications done right," she said.

The lack of child psychiatrists is a problem for all health insurers, including Medicaid.

Although about 71 percent of physicians accept new Medicaid patients, only about one-third of psychiatrists do, according to a study released this year by the Medicaid and CHIP Payment and Access Commission.

If you know a child who has talked about contemplating suicide, get help by calling the National Suicide Prevention Lifeline at 1-800-273-8255, or use the online Lifeline Crisis Chat, both available 24 hours a day, seven days a week.

Phil Galewitz: pgalewitz@kff.org, @philgalewitz

Home-based recovery appears to be best if the procedure is elective, friends and family are available to help and someone doesn't have serious conditions that could lead to complications.

This article was first published on March 28,2019 in Kaiser Health News.

By Judith Graham

Older adults and their families often wonder: Where's the best place to recover after a hip or knee replacement — at home or in a rehabilitation facility?

Increasingly, the answer appears to be home if the procedure is elective, friends and family are available to help and someone doesn't have serious conditions that could lead to complications.

This trend is likely to accelerate as evidence mounts that recuperating at home is a safe alternative and as hospitals alter medical practices in response to changing Medicare policies.

The newest data comes from a March study in JAMA Internal Medicine of 17 million Medicare hospitalizations of people from 2010 to 2016. All the patients were older adults and went home or to a skilled nursing facility after a medical procedure or a serious illness. Knee and hip replacements were the most common reason for these hospitalizations.

People who were sent home with home health care services demonstrated the same level of functional improvement as those who went to a skilled nursing facility (assessments examined their ability to walk and get up and down stairs, among other activities), the study found. And they were no more likely to die 30 days after surgery (a very small percentage in each group). Overall, costs were significantly lower for patients who went home, while hospital readmissions were slightly higher — a possible signal that home health care services needed strengthening or that family caregivers needed better education and training.

"What this study tells us is it's certainly safe to send people home under many circumstances," said Dr. Vincent Mor, a professor of health services, policy and practice at Brown University's School of Public Health who wrote an editorial accompanying the study.

The new report expands on previous research that came to a similar conclusion. In 2017, experts from New York City's Hospital for Special Surgery published a study that examined 2,400 patients who underwent total knee replacements and were discharged home or to a skilled nursing facility for rehabilitation between May 2007 and February 2011. There were no differences in complication rates at six months or in functional recovery and patient-reported outcomes at two years.

"As a result of these findings, we are encouraging all of our patients to consider home discharge after TKA [total knee replacement]," the authors wrote.

The year before, researchers at New York University reported in JAMA Internal Medicine that from 2009 to 2012 and 2013-14, discharges to rehabilitation facilities fell from 68 to 34 percent for patients undergoing hip and knee replacements, from 71 to 22 percent for patients with cardiac valve replacement surgeries, and from 40 to 30 percent for patients who'd had spinal fusion surgery. Instead, more people were sent home to recover. During this period, NYU Langone Medical Center assumed financial responsibility for "episodes of care" for joint replacements that include the post-hospital recovery period — a policy that Medicare is now promoting.

Diane Rubin, 67, who lives on Long Island, had a hip replacement at the NYU medical center in January. Before the surgery, she got a list of things she'd need to do to prepare for her recovery; afterward, a nurse and physical therapist visited her at home regularly for about three weeks. "I was more comfortable recuperating at home and I've had absolutely no complications," she said.

How do physicians decide where to send patients? "In general, we tend to send patients to skilled nursing facilities who are older, sicker, more deconditioned after surgery, and who have no spouse or caregiver, fewer resources and little social support," said Dr. Leora Horwitz, a co-author of that study and associate professor of population health and medicine at New York University School of Medicine.

Though it's widely believed that people who live alone might not do well going home, last year researchers at The Rothman Orthopaedic Institute at Thomas Jefferson University in Philadelphia published research showing that isn't necessarily the case. At their institution, patients are assigned a nurse navigator who provides assistance before and after hip or knee replacements. Patients who lived alone stayed in the hospital longer and received more home health care services than those who lived with others.

When they recuperated at home, the Rothman Orthopaedics patients didn't have higher rates of medical complications, returns to the hospital or emergency room visits than those who went to rehabilitation facilities. Nearly 90% of people who lived alone said they'd again choose a home discharge.

Dr. William Hozack, a co-author of the study and professor of orthopedic surgery at Thomas Jefferson University Medical School, acknowledged that patients who go to rehabilitation are probably sicker and more debilitated than those who go home, potentially biasing research results. Still, practices have changed considerably. Today, he and his colleagues send 95% of patients who get hip and knee replacements home to recover, instead of directing them to institutions.

People shouldn't underestimate how much help they may require at home, especially in the first few weeks after surgery, said Carol Levine, director of the United Hospital Fund's families and health care project, who has had two hip replacements. The potential downsides to going home include a greater burden on caregivers and the possibility that complications won't be identified as quickly, needs will go unmet if friends and family can't pitch in, and people won't follow through on recommended rehabilitation regimens. And outcomes may not be as favorable if services that support people at home aren't readily available

Utah's Intermountain Healthcare, a health system that operates 23 hospitals and nearly 170 medical clinics, is bringing an array of services — palliative care, dialysis, primary care and hospital care — into the home through its new Intermountain at Home program. Recovering at home after a hospital procedure is also a focus, and Intermountain has created standardized procedures for hip and knee replacements over the past few years, according to Rajesh Shrestha, the system's chief operating officer of community-based care.

Every joint-replacement patient going home after surgery now gets a thorough assessment to determine the resources that are needed. A care plan is created and a case manager, usually a registered nurse, makes sure that physical therapy, durable medical equipment and home health care are supplied. The case manager also coordinates postoperative care with orthopedic surgeons and makes sure that patients reconnect post-surgery with their primary care physicians. And a team of providers is available 24/7.

During the past few years, discharges to rehabilitation facilities have declined by half at most of Intermountain's Utah facilities, with no notable increase in complications or hospital readmissions, Shrestha said. During 2018, 85 percent of knee replacement patients and 88 percent of hip replacement patients went home after surgery, respectively.

At Kaiser Permanente, a health plan with more than 12 million members, a substantial number of patients who get elective hip and knee replacements are skipping a hospital stay altogether and going home the same day. In Kaiser's Southern California region, same-day joint replacement home discharges now total about 50%, according to Dr. Nithin Reddy, who oversees joint replacements for the region. (Kaiser Health News is not affiliated with Kaiser Permanente.)

Kaiser Permanente has made this possible by changing how procedures are done (an anterior approach for hip replacements, for example), introducing new protocols for pain management (opioids are used less frequently), altering anesthesia protocols (less general anesthesia and more regional anesthesia), reducing blood transfusions and hiring "total joint coordinators" (typically nurses) to help with the transition from the hospital to home. All patients go home with home health care, receive two outreach calls the week after surgery and get comprehensive handbooks with checklists of what to do before and after surgery and common concerns to look out for.

"We have very robust discharge criteria: Patients have to have well-managed pain and be able to get in and out of bed by themselves and in and out of the restroom by themselves. And they need to be able to walk 50 to 75 feet unassisted, using a walker," Reddy said. "If they can't do those things, they aren't safe for a home discharge and [rehabilitation at] a skilled nursing facility would come into play."

Magdalena Ritayik, 66, one of the doctor's patients, had a knee replacement last September after cortisone shots stopped working and pain became a constant companion. Six years before, her husband had both knees replaced, separately, and stayed in the hospital three days each time. By contrast, Ritayik went home the afternoon after her surgery, only to find a nurse and physical therapist waiting there for her.

"The nurse went over all the medications, when to take them and how much. The physical therapist showed me how to do bending and stretching with a chair in the living room and to raise [my leg] while I was lying on the bed," Ritayik said. "The first week you have to stay home. After the second week, I was walking almost like regular. A month after the surgery, I was at full extension and full bending."

We're eager to hear from readers about questions you'd like answered, problems you've been having with your care and advice you need in dealing with the health care system. Visit khn.org/columnists to submit your requests or tips.

Judith Graham: @judith_graham