The kidney doctor sat next to Judy Garrett's father, looking into his face, her hand on his arm. There are things I can do for you, she told the 87-year-old man, but if I do them I'm not sure you will like me very much.
The word "death" wasn't mentioned, but the doctor's meaning was clear: There was no hope of recovery from kidney failure. Garrett's father listened quietly. "I want to go home," he said.
It was a turning point for the man and his family. "This doctor showed us the reality of my father's condition," Garrett said, gratefully recalling the physician's compassion. A month later, her father passed away peacefully at home.
This kind of caring is what older adults want when they become seriously ill and move back and forth between the hospital and other settings, according to the largest study ever of patients' and caregivers' experiences with care transitions.
Two other priorities are also crucially important, according to recently published research: Patients and caregivers want to feel prepared to look after themselves or loved ones when they leave the hospital, and they want to know that their needs will be attended to until they stabilize or recover, however long that takes.
What's striking is how often hospitals fail to fulfill these expectations, even though it's been known for decades that care transitions are problematic and strategies to reduce preventable hospital readmissions have been widely adopted.
"Despite millions of dollars of investment and thousands of hours of effort, the health care system still feels very hazardous, unsafe and stressful from the perspective of patients and caregivers," said Dr. Suzanne Mitchell, assistant professor of family medicine at Boston University School of Medicine and lead author of the new report.
She's part of a team of experts spearheading Project ACHIEVE, a five-year, $15 million study investigating the effectiveness of interventions designed to improve care transitions. The focus is on what Medicare patients and caregivers need and want when a hospital stay ends and they return home.
One part of the project involves asking people who undergo these transitions — mostly older adults — about their experiences: what went well, what didn't. In addition to the new report, a survey of more than 9,000 patients and 3,000 caregivers is close to completion. Results will be published this fall.
Another part involves looking at what hospitals are doing to try to improve transitions, such as teaching patients and caregivers how to care for wounds or arranging follow-up phone calls with a nurse, among other strategies. A preliminary research report published last year found common problems with transition programs, including haphazard, uncoordinated approaches and a lack of teamwork and leadership.
Several areas deserve special attention, according to people who participated in focus groups and in-depth interviews for Project ACHIEVE:
Getting Actionable Information
Too often, doctors speak to patients and caregivers in "medicalese" and fail to address what patients really want to know — such as "What do I need to do to feel better?" — said Dr. Mark Williams, Project ACHIEVE's principal investigator and chief transformation and learning officer at the University of Kentucky HealthCare system.
"You really need someone to walk you through what you're going to need, step by step," Williams said.
Nothing of the sort occurred when Anita Brazill's parents, ages 86 and 87, were hospitalized seven times in Scranton, Pa., between Dec. 25, 2016, and Feb. 13, 2017.
First, her mother needed emergency gastrointestinal surgery, then her father became ill with pneumonia. Both went to an understaffed rehabilitation facility after leaving the hospital, and both bounced right back to the hospital — five times altogether — because of complications.
Each time her parents left the hospital, Brazill felt unprepared.
"You're out on the concrete of the discharge pavilion and they send you off by ambulance or car without a guidebook, without any sense of what to expect or who to call," she said.
Planning Collaboratively
Ideally, when preparing to release a patient, hospital staff should inquire about older patients' living circumstances, social support and the help they think they'll need, and discharge plans should be crafted collaboratively with caregivers.
In practice, this doesn't happen very often.
In May, Art Greenfield, 81, was admitted at 3 a.m. to a hospital near his home in Santa Clarita, Calif., with severe food poisoning and dehydration. Less than six hours later, after a sleepless night, a hospitalist he had never met walked into his room and told him she was sending him home because his situation had stabilized. (Hospitalists are physicians who specialize in caring for people in the hospital.)
"She had no idea if he could pee without the catheter they'd put in or get out of bed on his own," said Hedy Greenfield, 76, his wife. "I wasn't there, and no one asked him if there was somebody who could take care of him at home when he got there. Fortunately, he had the presence of mind to say I'm not ready, I need to stay another day."
Expressing Caring
Over and over again, patients and caregivers told Project ACHIEVE researchers how important it was to feel that health professionals care about their well-being.
Simple gestures can make a difference. "It's looking at you, rather than the computer," said Carol Levine, director of the families and health care project at United Hospital Fund in New York. "It's knowing your name and giving you a sense of ‘I'm here for you and on your side.'"
Without this sense of caring, patients and caregivers often feel abandoned and lose trust in health care professionals. With it, they feel better able to handle concerns and act on their doctors' recommendations.
Kathy Rust of Glendale, Calif., remembers walking into a room at an outpatient clinic and seeing a doctor stroking her mother's hair and calming her before reinserting a feeding tube that the 93-year-old woman had pulled out. "He was making sure she was comfortable," Rust said, recalling how moved she was by this doctor's sensitivity.
Anticipating Needs
Few people know what they'll need in the aftermath of a medical crisis: They want doctors, nurses, pharmacists, social workers or care managers to help them figure that out and devise a practical plan.
Under the CARE Act — now enacted in 36 states, the District of Columbia and Puerto Rico — hospital staff are required to ask patients if they want to identify a caregiver (some choose not to do so) and to educate that caregiver about medical responsibilities they'll face at home. But implementation has been inconsistent, Levine and other experts said.
Rust panicked the first time her mother's feeding tube came out, by accident. "I called the transition service at my hospital's outpatient clinic, and they sent someone over in 30 minutes," she said. "They were very reassuring that I had done the right thing in calling them, very calming. It was such a positive experience that I wasn't afraid to contact them with all kinds of questions that came up."
Too often, however, discharges are hurried and caregivers unaware of what they'll face at home. Levine tells of an older woman who was handed a pile of paperwork when her husband was being released from the hospital. "She couldn't read it because she had macular degeneration and no one had thought to ask ‘Do you understand this and do you have any questions?'"
Ensuring Continuity Of Care
"Patients and families tell us that once they leave the hospital, they don't know who's responsible for their care," said Karen Hirschman, an associate professor and NewCourtland Chair in Health Transitions Research at the University of Pennsylvania School of Nursing.
The name of a person to call with questions would be helpful as would round-the-clock access to emergency assistance — for months, if needed.
"It's not just ‘Now you're home and we called you a few times to follow up,'" Hirschman said. "It can take much longer for some patients to recover, and they want to know that someone is accountable for their well-being all the way through."
Judy Garrett found that having cellphone numbers for a home health care nurse and a doctor who made house calls was essential, until hospice took over shortly before her father's death.
"My advice to families is be physically present as much as possible, although I know that's not always easy," she said. "Appoint one person in the family to be the point person for medical professionals to reach out to. Request cellphone numbers, but use them only when you have to. And if you don't understand what professionals are telling you, ask until you do."
The Trump administration's decision Tuesday to slash funding to nonprofit groups that help Americans buy individual health insurance coverage sparked outrage from advocates of the Affordable Care Act. Using words like "immoral" and "cold-hearted," they saw it as the Republicans' latest act of sabotage against the sweeping health law.
But as the ACA's sixth open-enrollment period under the health law approaches in November, the lack of in-person assistance is unlikely to be a disaster for people seeking coverage, insurance and health experts say.
"I think alone it will have a very small impact on enrollment for 2019," said William Hoagland, a senior vice president with the Bipartisan Policy Center in Washington.
But combined with other recent actions by the Trump administration, the decision sets a negative tone, Hoagland said.
"It does send a signal of course that the administration is not promoting enrollment," he said.
The Centers for Medicare & Medicaid Services announced it is cutting money to the groups known as navigators from $36 million to $10 million for the upcoming 45-day enrollment period.
This reduction comes a year after the Trump administration decreased navigators' funding by 40 percent from $62.5 million — and cut advertising and other outreach activities.
CMS Administrator Seema Verma said the navigators that operate in the 34 states that use the federal marketplace — including many health and religious organizations — were ineffective and had outlived their usefulness.
She pointed out that they helped with fewer than 1 percent of enrollments in 2017 — though she counts navigators as "helping" only if consumers sign up in their presence.
CMS also notes that after last year's navigator funding was reduced, the overall enrollment in Obamacare plans increased slightly (when counting people who paid their first month's premiums) to 10.6 million people.
Florida Blue, an insurer that enrolls among the largest number of Obamacare consumers nationwide, said it won't miss the help from the federally funded grass-roots helpers.
"Given our large and unique distribution-channel strategy of utilizing our retail centers along with our telesales efforts, our dedicated field agents and our direct in-market enrollment efforts, we do not depend on navigators to enroll ACA members," said spokesman Paul Kluding.
Greg Fann, a fellow with the Society of Actuaries, said the role of navigators has been overstated.
"I am a numbers guy, and what really matters to people are the numbers and price of the coverage," he said. Nearly 9 in 10 people buying coverage on the ACA exchanges qualify for federal subsidies based on their incomes, and the amount those subsidies rose last year because of an increase in silver-plan premiums.
The navigators, Fann added, were needed more in 2013 and 2014 when the marketplaces were in their first years and millions of people who hadn't bought insurance before were considering the health law's new options.
Insurers and brokers, Fann said, should step in to make up for navigator funding.
Don't count on it, said Steve Israel, a Boynton Beach, Fla., insurance agent and past president of the Florida Association of Health Underwriters. He said most independent brokers want nothing to do with ACA plans because insurers have cut their commissions. "We've been sending people to navigators," Israel said.
Some states that operate their own marketplaces, however, are continuing to invest in these grass-roots aides.
Covered California, for example, is holding its navigator funding steady, dedicating $6.5 million to navigators in this year's budget.
That's more than half of what healthcare.gov is investing in navigators in 34 states.
California has 1.5 million people in Obamacare plans, second highest in the nation behind Florida, which has 1.6 million.
Death By 1,000 Cuts?
Trump spent his first year in office trying to repeal the health law and came within one vote in the U.S. Senate of achieving that goal. Immediately after Sen. John McCain (R-Ariz.) cast the deciding vote to block the dramatic repeal effort, Trump implored Republicans to let the law disintegrate.
"Let ObamaCare implode, then deal," Trump tweeted on July 28, 2017.
But his administration has not stood idly by.
The Republican-controlled Congress in December passed a law that next year will eliminate the requirement that most Americans have insurance, a move likely to drive healthier people out of insurance market and lead to higher prices for those who are left.
Just last week, CMS said because of a pending lawsuit it was suspending a program created by the law to even out the burden on health insurers whose customers are especially unhealthy or sick. That could take millions of dollars away from some insurers, causing them to hike prices or abandon markets.
The Trump administration also issued new rules to try to make it easier for individuals and small businesses to buy health plans that cost less than ACA coverage because they cover fewer medical services. These plans would bypass the law's protections that prevent companies from charging higher prices to women, older people and those with preexisting medical conditions.
Critics deride such plans as "junk insurance."
CMS now wants the navigators to promote these policies in addition to steering people toward ACA-compliant plans and Medicaid.
This adds to the concern about the lack of navigator funding.
The availability of such new types of coverage will increase consumer demand for specially trained navigators, said Elizabeth Hagan, a senior consultant with Transform Health, a consulting firm.
She said the problem with reducing consumer assistance is not so much that fewer people will buy coverage but that people will buy policies that don't fit their needs.
Jodi Ray, who leads the University of South Florida's navigator program — the largest one in the state — said her staffers do much more than help with enrollment. They also help consumers file appeals with insurers.
"This is how health care disparities are exacerbated — we will be put in the awful position of pitting populations that need assistance against each other in order to prioritize how we can use the resources," she said.
Senate Democrats, who are divided on abortion policy, are instead turning to health care as a rallying cry for opposition to President Donald Trump’s Supreme Court nominee.
Specifically, they are sounding the alarm that confirming conservative District Court Judge Brett Kavanaugh could jeopardize one of the Affordable Care Act’s most popular provisions — its protections for people with preexisting health conditions.
“Democrats believe the No. 1 issue in America is health care, and the ability of people to get good health care at prices they can afford,” said Senate Minority Leader Chuck Schumer (D-N.Y.).
The Kavanaugh nomination, he added, “would put a dagger” through the heart of that belief.
Democratic senators spent Tuesday trying to connect the dots between potential threats to health care and Trump’s high court pick.
“President Trump as a candidate made it very clear that his priority was to put justices on the court who would correct for the fatal flaw of John Roberts,” said Sen. Chris Murphy (D-Conn.) on the Senate floor Tuesday. Chief Justice Roberts was the decisive fifth vote to uphold the ACA in a key case in 2012. “[Republicans’] new strategy is to use the court system to invalidate the protections in the law for people with preexisting conditions,” Murphy said.
Murphy — and many of his Democratic colleagues — are referring to a case filed in Texas in February by 20 Republican state attorneys general. The AGs charge that because the tax bill passed by Congress last year eliminated the tax penalty for not having health insurance, it rendered the entire health law void.
Their reasoning was that Roberts based his opinion upholding the ACA on Congress’ taxing power. Without the tax, the AGs argue, the law should be held unconstitutional.
The Trump administration, which would typically defend the ACA because defending federal law is part of what the Justice Department is tasked to do, opted to follow a different course of action.
In a response filed in June, political appointees in the department said eliminating the penalty should not invalidate the entire law. But it should nullify provisions that prevent insurers from refusing to sell insurance to people with preexisting conditions or charging them higher premiums.
If this argument were to be upheld by a newly reconstituted Supreme Court, the health law would be dealt a serious blow.
The lawsuit, however, is only in its earliest stages. And many legal scholars on both sides doubt it will get very far.
In an amicus brief filed with the court in June, five liberal and conservative legal experts who disagreed on previous ACA cases argued that both the Republican attorneys general and the Justice Department are wrong — that eliminating the mandate penalty should have no impact on the rest of the law.
Their position is rooted in something called “congressional intent.” When a court wants to invalidate a portion of a law, it usually also has to determine whether Congress would have considered other aspects of the law unworkable without it.
But that is not a problem in this case, the legal experts argued in their brief. “Here, Congress itself has essentially eliminated the provision in question and left the rest of a statute standing,” they wrote. “In such cases, congressional intent is clear.”
The merits of the lawsuit notwithstanding, the issue works well for Democrats.
For one thing, the health law’s preexisting condition protections are among its most popular parts, according to public opinion polls.
And unlike abortion, defending the health law is something on which all Senate Democrats agree. That includes some vulnerable senators in states that voted for Trump in 2016, including Sens. Joe Manchin (D-W.Va.), Heidi Heitkamp (D-N.D.) and Joe Donnelly (D-Ind.). None are strong supporters of abortion rights. But all have stood firm against GOP efforts to take apart the Affordable Care Act.
Manchin, for example, said in a statement about the nomination, “The Supreme Court will ultimately decide if nearly 800,000 West Virginians with preexisting conditions will lose their health care.”
Manchin’s opponent in November is Republican Attorney General Patrick Morrisey. He is one of the officials who filed the suit against the health law.
Reversing the landmark case would not automatically make abortion illegal across the country. Instead, it would return the decision about abortion legality to the states.
What would the U.S. look like without Roe v. Wade, the 1973 case that legalized abortion nationwide?
That’s the question now that President Donald Trump has chosen conservative Judge Brett Kavanaugh as his nominee to replace retiring Supreme Court Justice Anthony Kennedy.
Reversing the landmark case would not automatically make abortion illegal across the country. Instead, it would return the decision about abortion legality to the states, where a patchwork of laws are already in place that render abortion more or less available, largely depending on individual states’ political leanings.
“We think there are 22 states likely to ban abortion without Roe,” due to a combination of factors including existing laws and regulation on the books and the positions of the governor and state legislature, said Amy Myrick, staff attorney at the Center for Reproductive Rights, which represents abortion-rights advocates in court.
“The threat level is very high now,” Myrick said.
Kavanaugh never opined on Roe v. Wade directly during his tenure on the U.S. District Court in Washington, D.C. In his 2006 confirmation hearing for that position, though, he said he would follow Roe v. Wade as a “binding precedent” of the Supreme Court — which lower-court judges are required to do.
Abortion opponents are buoyed by the pick.
“Judge Kavanaugh is an experienced, principled jurist with a strong record of protecting life and constitutional rights,” said a statement from Susan B. Anthony List President Marjorie Dannenfelser. She spearheaded support for Trump in his presidential campaign after he promised to appoint to the Supreme Court only justices who would overturn Roe v. Wade.
Kennedy, by contrast, was a swing vote on abortion issues. He frequently sided with conservatives to uphold abortion restrictions. However, in key cases in 1992 and 2016, he sided with liberals to uphold Roe’s core finding that the right to abortion is part of a right to privacy that is embedded within the U.S. Constitution.
Even now, with Roe v. Wade’s protections in place, a woman’s ability to access abortion is heavily dependent on where she lives.
According to an analysis by the Guttmacher Institute, a reproductive-rights think tank, 19 states adopted 63 new restrictions on abortion rights and access.
At the same time, 21 states adopted 58 measures last year intended to expand access to women’s reproductive health.
Since 2011, states have enacted nearly 1,200 separate abortion restrictions, according to Guttmacher, making these types of laws far more common.
As of now, four states — Louisiana, Mississippi and North and South Dakota — have what are known as abortion “trigger laws.” Those laws — passed long after Roe was handed down — would make abortion illegal if and when the Supreme Court were to say Roe is no more.
“They are designed to make abortion illegal immediately,” said Myrick.
Another dozen or so states still have pre-Roe abortion bans on the books.
Some have been formally blocked by the courts, but not repealed. Those bans could, at least in theory, be reinstated, although “someone would have to go into court and ask to lift that injunction,” said Myrick.
States could simply begin enforcing other bans that were never formally blocked, like one in Alabama that makes abortion providers subject to fines and up to a year in jail.
At the same time, Myrick said, “there are 20 states where abortion would probably remain safe and legal.”
The Path To The High Court
Several major challenges to state abortion laws are already in the judicial pipeline. One of these will have to get to the Supreme Court to enable a majority to overturn Roe v. Wade.
“It’s not a question of if, it’s a question of what or when,” said Sarah Lipton-Lubet, vice president for reproductive health and rights at the National Partnership for Women and Families.
The cases fall into three major categories.
The first — and most likely type to result in the court taking a broad look at Roe v. Wade — are “gestational” bans that seek to restrict abortion at a certain point in pregnancy, said Lipton-Lubet.
Mississippi has a 15-week ban, currently being challenged in federal court. Louisiana enacted a similar ban, but it would take effect only if Mississippi’s law is upheld. Iowa earlier this spring passed a six-week ban, although that is being challenged in state court, not federal, under the Iowa Constitution.
The second category involves regulations on abortion providers.
One pending case, for instance, involves an Arkansas law that would effectively ban medication abortions. Finally, there are bans on specific procedures, including several in Texas, Arkansas and Alabama that would outlaw “dilation and evacuation” abortions, which are the most common type used in the second trimester of pregnancy.
Myrick and Lipton-Lubet agree that there is no way to predict which abortion case is likely to reach the high court first.
The case that’s actually closest to the Supreme Court, noted Myrick, is a challenge to an Indiana law that would outlaw abortion if the woman is seeking it for sex selection or because the fetus could be disabled. A federal appeals court found that law unconstitutional in April.
Many analysts also agree that even with the court’s likely philosophical shift, Roe v. Wade might not actually be overturned at all.
Instead, said Lipton-Lubet, a more conservative court could “just hollow it out” by allowing restrictive state laws to stand.
“The court cares about things like its own legitimacy,” said Myrick, “and how often a precedent has been upheld in the past.” Given that Roe’s central finding — that the decision to have an abortion falls under the constitutional right to privacy — has been upheld three times, even an anti-abortion court might be loath to overrule it in its entirety.
The day a gunman fired into a crowd of 22,000 people at the country music festival in Las Vegas, hospital nursing supervisor Antoinette Mullan was focused on one thing: saving lives.
She recalls dead bodies on gurneys across the triage floor, a trauma bay full of victims. But "in that moment, we're not aware of anything else but taking care of what's in front of us," Mullan said.
Proud as she was of the work her team did, she calls it "the most horrific evening of my life" — the culmination of years of searing experiences she has tried to work through, mostly on her own.
"I can tell you that after 30 years, I still have emotional breakdowns and I never know when it's going to hit me," said Mullan.
Calamities seem to be multiplying in recent years, including mass shootings, fires, hurricanes and mudslides. Just last week, a gunman burst into the newsroom of the Capital Gazette in Annapolis, Md., killing five journalists and injuring two others.
Many of the men and women who respond to these tragedies have become heroes and victims at once. Some firefighters, emergency medical providers, law enforcement officers and others say the scale, sadness and sometimes sheer gruesomeness of their experiences haunt them, leading to tearfulness and depression, job burnout, substance abuse, relationship problems, even suicide.
Many, like Mullan, are stoic, forgoing counseling even when it is offered.
"I don't have this sense that I need to go and speak to someone," said Mullan. "Maybe I do, and I just don't know it."
In 2017, there were 346 mass shootings nationwide, including the Las Vegas massacre — one of the deadliest in U.S. history — according to Gun Violence Archive, a nonprofit organization that tracks the country's gun-related deaths.
The group, which defines mass shootings as ones in which four or more people are killed or injured, has identified 159 so far this year, through July 3.
Signs that read "Vegas Strong" can be seen all around Las Vegas. "Certain things trigger emotions that I didn't expect," says Antoinette Mullan, nursing supervisor at University Medical Center of Southern Nevada. (Heidi de Marco/KHN)
The "first responders" who provide emergency aid have been hit hard not just by recent large-scale disasters but by the accumulation of stress and trauma over many years, research shows. Many studies have found elevated rates of post-traumatic stress disorder among nurses, firefighters and paramedics. A 2016 report by the International Association of Fire Fighters found that firefighters and paramedics are exhibiting levels of PTSD similar to that of combat veterans.
Experts have found a dearth of research on treatment, insufficient preparation by employers for traumatic events and significant stigma associated with seeking care for the emotional fallout of those events.
"When we have these national disasters or have a guy take a truck and run people over … those are added stressors we aren't prepared for," said Jeff Dill, a former firefighter and licensed counselor.
Dill said the emotional toll of these large-scale horrific events is magnified because everyone is talking about them. They are inescapable and become emotional "trigger points."
"Anniversaries are the hardest," he said.
Some employers are working on developing greater peer support, he said, but it often comes after the fact rather than proactively. "We met a lot of resistance early on because of the [stoic] culture," said Dill, who travels the country teaching mental health awareness workshops for firefighters and other emergency personnel.
He said the culture is slowly shifting — particularly because of the rise in mass public shootings across the country.
‘I Was Scared'
In 2015, Gary Schuelke, a police watch commander, raced to the scene of a holiday party in San Bernardino, Calif., where he and his fellow officers faced a fusillade of gunfire from a pair of homegrown terrorists.
He'd seen a lot on the force over the years, but this call was different — and not just because of the numerous casualties. His son, a young police officer, was there with him.
Schuelke and his son, Ryan, chased the assailants' car as the bullets whizzed by. It was the younger Schuelke's first time exchanging fire with suspects.
The Inland Regional Center (IRC) in San Bernardino, Calif. (Heidi de Marco/KHN)
Afterward, when both were safe, "I asked him, You doing OK?" Gary Schuelke recounted. "If you're not, it's cool. You can talk to me about it. He said, ‘I'm good, Dad. I'm very happy to be part of taking down the bad guys.'"
Ryan was "just like I was when I was in my 20s … chasing bad guys and making arrests," the elder Schuelke said. He said he had decided early in his career to try to "compartmentalize" his work experiences so they wouldn't affect his personal life.
Still, certain calls have stuck with him. Like many first responders, he is particularly affected when kids are hurt or killed. He still recalls his first homicide, a 13-year-old girl shot in the hip.
"She bled out and took her last breath right there in front of me," Schuelke said. "That was the first time I was like, man, this job is real."
Generally, no one focused on officers' mental health back then, he said, but experience has taught him how important it is to do just that. After the 2014 terrorist attack, which left 14 would-be revelers dead, his department quickly set up a "debriefing" meeting for the officers involved.
"I made it a point in that meeting that I was going to talk about the fact that I was scared," said Schuelke. "Not try to be macho in there and act like nothing bothered me about it."
Cumulative Stress
In 25 years as a firefighter, Randy Globerman was called upon time and again to cope with other people's traumas and disasters. He never really took account of how the experiences affected him.
"You spend all your career suppressing that stuff," he said.
Then came the Thomas Fire, considered the largest in California's history, which decimated hundreds of homes in Ventura and Santa Barbara counties. As his fellow firefighters were deployed to save what they could of their community, Globerman faced the real prospect of losing his own home.
For 36 hours, armed only with a bucket and water from his Jacuzzi, he fought to keep the flames back. He was frantic. "I was kind of a mess," said Globerman, 49. "I felt sick, I felt sad. I went through all sorts of crazy emotions."
A memorial sign near the Inland Regional Center (IRC) in San Bernardino honors the 14 people killed and 22 others seriously injured during a shooting on Dec. 2, 2015. (Heidi de Marco/KHN)
In the end, he was successful — his home survived — and he went back to work, responding just months later to mudslides from the denuded, rain-soaked hills.
But Globerman struggled emotionally, and, as experts say is often the case among first responders, it affected his family life.
"My kids would do something silly that would otherwise make me laugh, but instead I would start crying," he said.
He experienced several episodes in which he felt as if he was having a heart attack. "It would come out of nowhere," Globerman said. "I felt like I was losing my mind."
He thinks now that his own near disaster unleashed "demons" he didn't even know he had from incidents throughout his career. And he felt he couldn't ask for help.
"A lot of the support you'd get from a normal incident wasn't there," he said. "Other than a few people, everybody worked on the fire for about a month straight."
He struggled through it on his own. Anxiety medication seemed to help. He said he's not proud of having used it, but "after five months, I can honestly say that the demons don't seem to bother me anymore."
Mullan, the Las Vegas nurse who did not seek counseling, said she is not sure she has "processed" the mass shooting almost a year later.
"Certain things trigger emotions that I didn't expect," Mullan said.
At a recent luncheon she attended, victims from the shooting shared their stories.
"It hit me like a ton of bricks," Mullan said. "And, yes, I did cry."
The effort developed partly out of the realization that untreated mental health conditions negatively affect patients' physical health, thus costing the system more money.
AUSTIN, Texas — Kerstin Taylor fought alcohol and substance abuse problems for two decades. She periodically sought help through addiction and psychiatric treatments to stay sober, but she continued to relapse.
That unrelenting roller coaster, and the emotional and mental fallout, left her with little energy or resources to take charge of her overall health. Taylor, 53, has asthma and doctors told her she was at risk of developing diabetes.
"I wasn't doing anything to help myself," she said about her physical health.
Then an opportunity to get coordinated mental and physical health care services helped turn life around for Taylor, who also lives with bipolar and obsessive-compulsive disorders.
Until recently, health care professionals, in general, treated the mind and body separately and cared for them under different systems. That meant someone like Taylor, who relies on public transportation, had trouble getting to referrals for physical care at locations far away from her psychiatric appointments. That made follow-ups unlikely.
In 2012, Integral Care in Austin offered Taylor a holistic approach, with access to physical health care and a program to manage chronic disease, on top of her regular psychiatric care. Many of the services were available either at the clinic or in her home, and one case manager would help Taylor handle it all.
The seamless care made a big difference, Taylor said, because her recovery depends on addressing all aspects of her health, not just her mental state.
"With chronic-disease [management], resting well, good nutrition, that's a full package right there," Taylor said. "It has really built me up to be a better woman."
Now she has her own efficiency apartment in south Austin and plans to volunteer for a local animal charity. She walks regularly with a chronic-disease case manager and has taken courses to learn how to cook healthful food on a budget.
Efforts to provide integrated care are spreading, especially in public health clinics.
It developed partly out of the realization that untreated mental health conditions negatively affect patients' physical health, thus costing the system more money.
And in 2010, the Affordable Care Act established a mandate to give parity to mental health services.
A desire to reduce costly emergency room visits also is driving the trend.
A 2007 survey conducted by the Agency for Healthcare Research and Quality indicated that 1 in 8 emergency room visits were related to a mental health or substance abuse diagnosis. Those patients were also more than twice as likely to be admitted to the hospital during that visit.
Over the past decade, the federal government has bet on integrated care to help relieve the problem. From 2009 to 2015, the Substance Abuse and Mental Health Services Administration (SAMHSA) awarded 187 grants worth over $162 million to implement integrated care models.
The Centers for Medicare & Medicaid Services also is investing in integrated care. A 2013 report by SAMHSA found that Medicaid is the largest single payer for mental health services, and nearly a quarter of the inpatient hospital stays covered by the program were for mental health and substance abuse issues.
In Texas, 64 of the state's 73 federally qualified health centers offer some mental health services, according to data from the Health Resources and Services Administration. That's a jump from just 36 clinics over a decade ago.
Integrated health care is "fundamental" to achieving state goals such as reducing suicide rates, lowering incarceration rates for people with mental health issues and developing a savvier mental health care workforce, according to the state's behavioral health strategic plan.
Learning To Be Flexible And Multitask
Austin's CommUnity Care is a federally qualified health care clinic that serves mostly low-income and uninsured patients in several locations around the city. Pediatrician Tracy Lama-Briseño sees the benefits and challenges of integrated care there every day.
She said the average person would be surprised to learn how many young children and teens deal with mental health issues.
"We do have some pretty young kids that start to present at an early age with symptoms of anxiety or sadness," she said. "Parents separating … the loss of a loved one. All that can be pretty confusing to a young child."
Lama-Briseño's clinic sees about 23,000 medical patients per year, approximately 1,700 of whom use mental health services.
Sometimes the boundaries of responsibility can get blurred between mental and physical health care, she said. "I feel like I do a little bit more social work than I would like," she said. "But in the end, it's about taking care of the kids and the families."
Addressing mental health in primary care gives access to people who might never seek it out, but it also opens the door to additional responsibilities for Lama-Briseño. For instance, CommUnity Care administers a two-question depression screening to every new patient older than 12 and repeats it for existing patients once a year. The results can prompt further action.
Lama-Briseño describes how her young patients can come in for one thing, like an earache, and then the visit turns into something completely different. She said it all happens quickly.
"You can't say ‘OK, make another appointment,'" she added. "It has to be, you know, dealt with then and there. And so I definitely had to learn how to be flexible and sort of multitask."
Lack Of Mental Health Specialists
One of the challenges for the integrated model is recruiting mental health professionals. Approximately 1 million adults statewide have a "serious mental illness," according to the Texas Health and Human Services Commission, and more than 80 percent of Texas' 254 counties don't have enough mental health professionals to care for patients.
"My concern, actually, is that we don't have a big enough pipeline to fill these jobs that are gonna be available," said Neftali Serrano, executive director of the Collaborative Family Healthcare Association, an advocacy group for integrated care.
Serrano likened the problem to trying to build a plane while flying it. The health care system can't just stop, so people need to be trained in this new way so that, as integrated care becomes more common, they'll be ready to work, he said.
"This is not just about plopping a mental health professional in a primary care setting," he said. "It takes … a certain kind of behavioral health professional, and well-trained physicians and nurse practitioners and [physician assistants] to do this work well."
Buy-in from primary care doctors is another piece to the complicated puzzle of integrated care. While surveys show many support integrating mental health professionals with primary care, some lack the incentive to change their practices.
Dr. Ernest Buck is chief medical officer of Driscoll Health Plan, which serves mostly kids and families on Medicaid in a highly rural area that spans 26,000 square miles from south of San Antonio all the way down to Brownsville. Buck said most practices in his network aren't willing to bring on a therapist.
"It's hard to start a new model where a physician's practice could be put at risk, particularly at Medicaid rates," which tend to be lower than private insurance plan payments, he said.
Also, many primary care doctors simply weren't trained to work this way — collaboratively, on a team with mental health professionals.
Bill Tierney, head of Population Health at the University of Texas-Austin's Dell Medical School, said that when he was a practicing family doctor he rarely worked with mental health professionals.
"For 15 years, I practiced with no mental health support," he said. "If I sent [patients] to the mental health clinic, I didn't know whether they got there. They had a separate information system, I couldn't see how they were being treated, and patients often didn't want to go to see the shrink."
The company's former CEO has been indicted, and it has faced lawsuits from contractors alleging unpaid debts, including suits brought by two of its former doctors.
One of the largest pain management groups in the Southeast is closing multiple clinics amid worsening financial troubles and a federal criminal investigation that targeted its former chief executive.
This week, Tennessee-based Comprehensive Pain Specialists advised patients and employees about clinic closures, leaving patients scrambling to find new doctors willing to prescribe them opioids, according to a report on WSMV television.
Based in the Nashville area, CPS opened in 2005 and quickly grew into a powerhouse, which has treated as many as 48,000 pain patients a month, at more than 50 clinics in Tennessee and other states.
CPS did not respond to numerous requests for comment.
The doctor-owned company has endured a series of recent setbacks, including earlier clinic closures, pending lawsuits over alleged debts and the criminal case against former CEO John Davis.
In April, a federal grand jury in Tennessee indicted Davis on criminal kickback charges. He has pleaded not guilty. CPS also has faced nearly a dozen civil lawsuits from contractors alleging unpaid debts, including suits brought by two of its former doctors. A Justice Department official said the closure was not related to the criminal case against Davis.
The shutdown of the clinics comes amid growing backlash against the use of opioids for treating chronic pain. The opioid crisis has cost the U.S. economy more than $1 trillion since 2001, estimates Altarum, an economic research firm. Since 1999, at least 200,000 people have died nationwide from overdoses, according to the Centers for Disease Control and Prevention.
According to the company's website, CPS now operates 40 clinics in eight states: Arkansas, Illinois, Indiana, Kentucky, Mississippi, North Carolina, Ohio and Tennessee. Half are in Tennessee. The Tennessean reported Tuesday that all 21 clinics in the state would be closing by the end of the month.
CPS was the subject of a November 2017 investigation by Kaiser Health News that scrutinized its Medicare billings for urine drug testing. Medicare paid the company at least $11 million for urine screenings and related tests in 2014, when five of CPS' medical professionals stood among the nation's top such Medicare billers. One nurse practitioner at a CPS clinic in Cleveland, Tenn., generated $1.1 million in urine-test billing that year, according to Medicare records analyzed by KHN.
Peter Kroll, an anesthesiologist and one of CPS' founders, said at the time that the tests were justified to monitor patients against risks of addiction or reduce chances the pills might be sold on the black market. Kroll, who is the company's current CEO and medical director, billed Medicare $1.8 million for urine tests in 2015, agency records showed.
Kroll took charge of the business when Davis left the company abruptly last summer. He could not be reached for comment Tuesday.
Federal prosecutors charged Davis with accepting more than $750,000 in illegal bribes and kickbacks in a scheme that billed Medicare $4.6 million for durable medical equipment.
"As CEO, Davis oversaw the substantial expansion of CPS, recruiting new physicians and clinics to join CPS, as well as directing various aspects of the company's overall treatment of patients," prosecutors wrote in a May court filing.
Davis has pleaded not guilty. The U.S. attorney's office has said in court filings that CPS and its employees are "victims" in the case.
The company also has been hit with civil suits. Anesthesiologist Donald E. Jones sued the company in May 2017, alleging that it failed to honor his employment contracts.
Jones said he joined the firm in 2012 to staff three Tennessee clinics at a salary of $30,000 a month plus a percentage of fees from laboratory and other services. Jones argued that he generated collections in excess of $9 million. In 2016, the clinics served 41,364 patients, the busiest of all the clinics, according to the suit.
But in April 2016, according to the suit, CPS quit paying him and in February 2017 the company began transferring his patients to other clinics and "making disparaging remarks" about him to patients.
CPS countered that Jones failed to deliver "safe and effective medical care, which CPS in court filings attributed to an "ongoing compensation dispute." The suit is pending.
Pain specialist William Wagner also is suing the company. He said he relocated from New Mexico to open a CPS clinic in Anderson, S.C., lured by the promise of $30,000 a month in salary and a share of the profits from urine tests and other services.
Instead, according to Wagner, CPS failed to collect bills for services he rendered and then closed the clinic. CPS denies Wagner's claims and says it fulfilled its obligations under the contract. In a counterclaim, CPS argues that Wagner owes it $190,000. The case is pending.
Several contractors, including companies that leased office space and medical software, also have taken CPS to court alleging unpaid bills and leases, according to court filings. The cases are pending.
Kroll told KHN last year that he and fellow anesthesiologist Steve Dickerson came up with the idea for CPS in August 2005, over a cup of coffee at a Nashville Starbucks. At the time, Tennessee was confronting an emerging opioid epidemic.
Kroll, raised in North Carolina, had moved to Nashville to launch a career in anesthesiology, a specialty he chose after watching his older brother die from an agonizing disease with little help from pain specialists.
Joined by two other doctors, Kroll and Dickerson opened with a single storefront in suburban Hendersonville. Dickerson, who was elected to the Tennessee Senate in 2012, remains at CPS, according to its website. Calls to Dickerson's office were not returned.
A growing number of nurse practitioners—typically, registered nurses who have completed a master's degree in nursing—are adding up to a year of clinical and other training, often in primary care.
The patient at the clinic was in his 40s and had lost both his legs to Type 1 diabetes. He had mental health and substance abuse problems and was taking large amounts of opioids to manage pain. He was assigned to Nichole Mitchell, who in 2014 was a newly minted nurse practitioner in her first week of a one-year postgraduate residency program at the Community Health Center clinic in Middletown, Conn.
In a regular clinical appointment, “I would have been given 20 minutes with him, and would have been without the support or knowledge of how to treat pain or Type 1 diabetes,” she said.
But her residency program gives the nurse practitioners extra time to assess patients, allowing her to come up with a plan for the man’s care, she said, with a doctor at her side to whom she could put all her questions.
A few years later, Mitchell is still at that clinic and now mentors nurse practitioner residents. She has developed a specialty in caring for patients with HIV and hepatitis C, as well as transgender health care.
The residency program “gives you the space to explore things you’re interested in in family practice,” Mitchell said. “There’s no way I could have gotten that training without the residency.”
Mitchell is part of a growing cadre of nurse practitioners — typically, registered nurses who have completed a master’s degree in nursing — who tack on up to a year of clinical and other training, often in primary care.
Residencies may be at federally qualified health centers, Veterans Affairs medical centers or private practices and hospital systems. Patients run the gamut, but many are low-income and have complicated needs.
Proponents say the programs help prepare new nurse practitioners to deal with the growing number of patients with complex health issues. But detractors say that a standard training program already provides adequate preparation to handle patients with serious health care needs. Nurse practitioners who choose not to do a residency, as the vast majority of the 23,000 who graduate each year do not, are well qualified to provide good patient care, they say.
As many communities, especially rural ones, struggle to attract medical providers, it’s increasingly likely that patients will see a nurse practitioner rather than a medical doctor when they need care. In 2016, nurse practitioners made up a quarter of primary care providers in rural areas and 23 percent in non-rural areas, up from 17.6 and 15.9 percent, respectively, in 2008, according to a study in the June issue of Health Affairs.
Depending on the state, they may practice independently of physicians or with varying degrees of oversight. Research has shown that nurse practitioners generally provide care that’s comparable to that of doctors in terms of quality, safety and effectiveness.
But their training differs. Unlike the three-year residency programs that doctors must generally complete after medical school in order to practice medicine, nurse practitioner residency programs, sometimes called fellowships, are completely voluntary. Like medical school residents, though, the nurse practitioner residents work for a fraction of what they would make at a regular job, typically about half to three-quarters of a normal salary.
Advocates say it’s worth it.
“It’s a very difficult transition to go from excellent nurse practitioner training to full scope-of-practice provider,” said Margaret Flinter, a nurse practitioner who is senior vice president and clinical director of Community Health Center, a network of community health centers in Connecticut.
“My experience was that too often, too many junior NPs found it a difficult transition, and we lost people, maybe forever, based on the intensity and readiness for seeing people” at our centers.
Flinter started the first nurse practitioner residency program in 2007. There are now more than 50 postgraduate primary care residency programs nationwide, she said. Mentored clinical training is a key part of the programs, but they typically also include formal lectures and clinical rotations in other specialties.
Not everyone is as gung-ho about the need for nurse practitioner residency programs, though.
“There’s a lot of debate within the community,” said Joyce Knestrick, president of the American Association of Nurse Practitioners. Knestrick practices in Wheeling, W.Va., a rural area about an hour’s drive from Pittsburgh. She said that there could be a benefit if a nurse practitioner wanted to switch from primary care to work in a cardiology practice, for example. But otherwise she’s not sold on the idea.
A position statement from the Nurse Practitioner Roundtable, a group of professional organizations of which AANP is a member, offered this assessment: “Forty years of patient outcomes and clinical research demonstrates that nurse practitioners consistently provide high quality, competent care. Additional post-graduate preparation is not required or necessary for entry into practice.”
“We already have good outcomes to show that our current educational system has been effective,” Knestrick said. “So I’m not really sure what the benefit is for residencies.”
The fallout from Friday's federal court ruling that struck down the Medicaid work requirement in Kentucky was swift.
The decision by Judge James Boasberg immediately blocked Kentucky from enacting the provision in Campbell County, which had been set to start Sunday and roll out statewide later this year.
Within 36 hours, Kentucky Gov. Matt Bevin, a Republican, eliminated vision and dental benefits to nearly 500,000 Medicaid enrollees, saying the state could no longer afford it.
Meanwhile, Arkansas, New Hampshire and Indiana are moving ahead with the implementation of their versions of a Medicaid work requirement. It is not clear how or if Boasberg's ruling invalidating the Trump administration's approval of Kentucky's plan affects these states.
Arkansas is implementing its requirement this summer while New Hampshire and Indiana plan to phase in their rules beginning In January.
Virginia health officials say they still plan to seek federal permission to enact a work requirement but it isn't needed in order to expand Medicaid eligibility on Jan.1.
Virginia lawmakers approved Medicaid expansion in June with the condition the state apply for federal permission to include the new mandate.
"We remain focused on the work necessary to ensure that new health coverage for Virginia adults is available beginning on January 1, 2019," Dr. Jennifer Lee, director of the Virginia Department of Medical Assistance Services, said in a statement. "Developing a waiver is a separate and ongoing process, as described in the final state budget."
Virginia Medicaid is in discussions with the U.S. Centers for Medicare & Medicaid Services about its waiver, which has not yet been submitted.
Many Republican lawmakers in Virginia voted to expand Medicaid only after it was assured new enrollees would have to work or do volunteer service.
Dr. Scott Garrett, a Virginia House member from Lynchburg, Va., said he was under the impression the bill signed in June by Virginia Gov. Ralph Northam, a Democrat, meant the Medicaid expansion would begin only with a work requirement in place.
"The intent of the General Assembly … was that you could not do one absent the other," he said.
Garrett, a Republican, said he long opposed plans to add 400,000 adults to Medicaid because of cost concerns. He said requiring these enrollees to work or do volunteer service would make them healthier and improve their well-being.
Patricia Boozang, senior managing director for Manatt Health, a consulting firm, said she is not surprised states are moving ahead with work requirement plans regardless of the court ruling, which was specific to Kentucky.
She said the decision would cause the Trump administration to review the pending applications more closely so they could withstand a judicial review.
The federal court said Health and Human Services Secretary Alex Azar did not adequately take into account how many people would lose coverage for the work requirement and did not prove such a provision would improve enrollees' health.
"It's going to be challenging for them to make the case that health and well-being is going to be improved by the [work requirement] waiver," she said.
In Arkansas, some Medicaid enrollees face a Thursday deadline to register their status — that they worked, did volunteer service in June or meet one of the state's many exemptions.
"The ruling does not have an immediate effect on Arkansas' work requirement," said spokeswoman Marci Manley.
Advocates for low-income people are weighing whether to file lawsuits to stop the work requirement in other states that have won federal approval.
"We have … partnerships with state legal advocates in these states and are exploring enforcement and litigation options with them," said Jane Perkins, legal director of the National Health Law Program, which filed the suit on behalf of Medicaid enrollees in Kentucky to block the work requirements.
The issue of conflicts of interest has become more pressing in recent years as drug prices soar and health care companies reach out to the academic and policy community for advice.
When Dr. Mark McClellan sat for an in-depth 30-minute question-and-answer session at an April health policy forum, the audience was filled with top researchers, advocates and Capitol Hill staffers eager to hear what insight the former head of the Food and Drug Administration would dispense.
He did not disappoint.
In response to a question about how competition might drive down the cost of new drugs made from living cells, McClellan said, "That is a great example of where more clarity from FDA about what exactly is required could potentially open up more biosimilar competition."
McClellan is director of the Margolis Center for Health Policy at Duke University, the academic position by which he’s commonly identified. But he frequently has not disclosed another position he’s held since late 2013: He earned $285,000 last year on the board of pharmaceutical giant Johnson & Johnson, a company accused of blocking the sale of Pfizer’s Inflectra biosimilar, which competes against J&J’s blockbuster Remicade, a rheumatoid arthritis drug.
According to corporate financial filings, McClellan has been compensated with more than $1 million in cash and stock awards since taking that post.
McClellan also receives compensation as a member of the advisory board of privately held Alignment Healthcare, which employs doctors and provides chronic-care management for Medicare Advantage plans in three states. Alignment Healthcare declined to disclose his compensation.
The issue of conflicts of interest has become more pressing in recent years as drug prices soar and health care companies reach out to the academic and policy community for advice — often with generous payments attached, ethics experts say.
Sen. Claire McCaskill (D-Mo.) introduced a bill in June that would require drugmakers to report payments to patient advocacy groups and professional societies. If passed, it would toughen the Sunshine Act, which requires pharmaceutical companies to report payments to teaching hospitals and physicians, detailing how much was paid annually to doctors for travel, speaking and food.
As a board member to these for-profit health care companies, McClellan has a fiduciary obligation "not to injure them" when writing articles and speaking, said Stephen Bainbridge, law professor at UCLA.
And while there is no legal requirement to disclose board memberships when writing for journals or speaking, Bainbridge and other experts agreed there is an ethical obligation.
"There’s certainly a potential conflict of interest there," Bainbridge said, adding that while serving on the board of Johnson & Johnson "you are dealing with an enormous company that has fingers in a lot of different pies."
McClellan said in an emailed statement that he provides specific disclosures on topics on which his interests might give the appearance of conflict, including in medical journals and at speaking engagements.
"My board memberships are public information and are broadly known within the field, and I stand by the independence and integrity of all my work," McClellan said.
Ellen de Graffenreid, director of communications at the Duke-Margolis Center, said it was "clear that Dr. McClellan disclosed his position on the Johnson & Johnson Board when a potential conflict of interest existed — that is, when the publication mentions drugs or devices that may intersect with J&J’s business." She said that while he serves on the J&J board, he "does not advocate for any positions on behalf the company."
McClellan is a prolific writer and speaker about how the U.S. health care system operates. He left his work at the Brookings Institution to become the founding director of Duke-Margolis in 2015. He ran the FDA from 2002 to 2004 and served as administrator of the U.S. Centers for Medicare & Medicaid Services from 2004 to 2006 before joining Brookings.
In a majority of the articles McClellan wrote for the Journal of the American Medical Association, he did not disclose his corporate connections when he filled out forms concerning potential conflicts of interest. Of 15 papers he wrote since 2013, McClellan disclosed his relationship with Johnson & Johnson three times.
Johnson & Johnson is a Fortune 500 health care giant, with more than $76 billion in annual sales and a range of products including pharmaceuticals, medical devices and consumer products that include brand names Aveeno, Tylenol and Neutrogena.
"I don’t think there’s any reason to cover up or ignore those [corporate] relationships," said Arthur Caplan, a professor of bioethics at New York University School of Medicine. "In general … I would say disclose more."
Journals, conferences and policy forums generally ask contributors to list their potential conflicts of interest — financial relationships that might in some way sway their opinion or color the audience’s perception of information they relay. But the experts themselves decide which connections to list.
At the April forum addressing high drug prices, which was hosted by Kaiser Permanente’s Institute for Health Policy, neither the forum’s agenda, nor the speaker’s introduction at the event mentioned McClellan’s Johnson & Johnson role. (Kaiser Health News is not affiliated with Kaiser Permanente.)
Kaiser Permanente’s John Nelson said speakers at the forums typically have extensive backgrounds and "thus we only provide abbreviated biographies when introducing them." Kaiser Permanente declined to say whether they knew of McClellan’s corporate roles.
Dr. Jerry Avorn, a professor of medicine at Harvard Medical School, said he favors disclosure of corporate roles and thinks "many [people] would argue that it should be for the reader and not the author" to determine whether there is a conflict of interest.
The question of when to disclose industry or nonprofit funding has been debated for decades, said Dr. Sandro Galea, who wrote about conflicts of interest and schools of public health last year in JAMA.
"There are public and private actors and both importantly shape the environment in which we are in," Galea said, adding that it has been "relatively standard practice" for those in academia to determine for themselves whether there is a conflict to disclose.
Bioethics professor Caplan said he could understand why some authors would choose not to disclose a board membership in every article, particularly if the article wasn’t directly related to the company or its products. Caplan serves as an unpaid chair of a compassionate use advisory committee based at New York University and funded by Janssen, which is a division of Johnson & Johnson.
"Just because you have a connection to a company, in my opinion, you don’t necessarily generate a conflict for everything that you do," Caplan said. "We have to get more sophisticated" about conflicts of interest, though he advocates personally for full disclosure.
Elite medical journals, including JAMA and the New England Journal of Medicine, have streamlined the conflicts of interest question by using a standard disclosure form created by the International Committee of Medical Journal Editors.
JAMA media relations manager Deanna Bellandi declined to release McClellan’s ICMJE forms and said, "We publish what authors provide."
The New England Journal of Medicine publishes the ICMJE forms with its manuscripts. McClellan disclosed his role at Johnson & Johnson in a 2015 letter to NEJM about the 21st Century Cures Act, a sweeping law that increases funding for disease research and alters the regulatory system for drugs and medical devices. But he did not disclose any corporate roles in two recent articles for NEJM Catalysts, a separate publication that requires authors to fill out a separate disclosure form. Those 2017 articles focused on payment reform and private-sector entrepreneurship in health care.
When completing the standard ICMJE disclosure form, an author fills out a series of sections. Section 3 notes: "You should disclose interactions with ANY entity that could be considered broadly relevant to the work." And it tells the author to report "all sources of revenue paid (or promised to be paid) directly to you or your institution on your behalf over the 36 months prior to submission of the work."
The Duke-Margolis Center and McClellan have been at the forefront of discussions on the merits of using real-world evidence, a somewhat controversial topic that could alter the way drugs are regulated and approved. The idea is that once a drug is on the market, the patients’ experience might in part supplant rigorous and expensive clinical trials.
Johnson & Johnson, whose executives are open proponents of the use of real-world evidence, did not respond to requests for comment.
McClellan did not disclose his J&J board membership in a 2017 white paper about real-world evidence, which was funded in part by the FDA. In September 2017, McClellan's role at J&J was not disclosed during a public event done in coordination with the FDA. In December, Duke-Margolis announced a Real-World Evidence Collaborative, which is funded by pharmaceutical companies including Johnson & Johnson.
In May, a $4.2 million FDA grant was reposted for bids after concerns that Duke-Margolis was the sole bidder listed on the grant. The grant focuses on the drug approval process and research initiatives in the 21st Century Cures Act, including the potential benefits of using real-world evidence to analyze whether a drug works instead of rigorous and expensive clinical trials.
"Billions of dollars ride on the evidence that the FDA will accept for whether or not a drug is safe and effective," said Avorn, whose center does similar research on drug pricing.