Texas Gov. Greg Abbott signed legislation shielding patients from getting a huge bill when their insurance company and medical provider can't agree on payment.
This article was first published on Tuesday, June 18, 2019 in Kaiser Health News.
Texas is now among more than a dozen states that have cracked down on the practice of surprise medical billing.
Texas Gov. Greg Abbott, a Republican, signed legislation Friday shielding patients from getting a huge bill when their insurance company and medical provider can't agree on payment.
The bipartisan legislation removes patients from the middle of price disputes between a health insurance company and a hospital or other medical provider.
"We wanted to try to take the patients — get them out of the middle of it, because really it's not their fight," said Republican state Sen. Kelly Hancock, the bill's author.
Under the new law, insurance companies and medical providers can enter into arbitration to negotiate a payment — and state officials would oversee that process.
Surprise medical billing typically happens when someone with health insurance goes to a hospital during an emergency and that hospital is out-of-network. It also occurs if a patient goes to an in-network hospital and their doctors or medical providers are not in-network. Sometimes insurance companies and medical providers won't agree on what's a fair price for that care and patients end up with a hefty medical bill.
Consumer advocates in the state have urged lawmakers to do more to help Texans saddled with surprise medical bills.
Drew Calver is among the many Texans who have dealt with a surprise bill in the past few years. Calver, a high school history teacher in Austin, had a heart attack in 2017. He was rushed to the closest hospital by a friend that day, and doctors implanted stents to save his life.
Even though he had health insurance that paid the hospital more than $55,000 for his care, Calver ended up with a $109,000 bill. Calver and his wife, Erin, fought with the hospital and the insurance company for months with little success.
The Calvers eventually turned to the press. Last summer, he told his story to the "Bill of the Month" investigation from NPR and Kaiser Health News. "CBS This Morning" also covered the story. Shortly afterward, his bill was slashed to just $332. Erin Calver said she has seen her family's story strike a chord.
"For whatever reason, people could relate to us — and be scared that maybe it could happen to them," she said.
Drew Calver said he encounters many people who worry about the issue.
"The doctor that put my stents in — he either just had a baby or is about to have a baby — and he was saying that, 'Yeah that could happen to me, too!'" Calver said.
In fact, getting a steep hospital bill is something many Americans call their biggest financial fear.
"Polling shows us that the top household pocketbook concern for consumers is a surprise medical bill," said Stacey Pogue with the Center for Public Policy Priorities, a think tank that analyzes health and economic issues in Texas. "And that's actually pretty shocking that consumers will say they are more worried about their ability to afford a surprise medical bill than their health insurance premiums [and] their really high deductibles."
Last year, a Kaiser Family Foundation poll found that 67% of people worry about unexpected medical bills — a larger share than those who say they worry about prescription drug costs or basic necessities such as rent, food and gas. (KHN is an editorially independent program of the foundation.)
Pogue said that's a big reason why lawmakers in the state took the issue seriously and passed legislation that she said is now one of the strongest state protections she has seen.
"It is as strong or stronger than any of the protections in the country," Pogue said.
In addition to Texas, neighboring states Colorado and New Mexico also passed legislation in 2019 to address the problem of surprise out-of-network bills. The Commonwealth Fund's most recent report on the issue found about half of states offer some legal protections from surprise bills, but only six states had laws that provide "comprehensive" consumer protections similar to those just passed in Texas.
Texas' new surprise bill law officially takes effect Sept. 1, 2020.
Hancock said the fight over who pays disputed bills will be back where it belongs: with insurance companies, leaving the hospitals, doctors and labs to focus on providing medical care.
"It was just time to get the patient out" of the middle of disputed bills, Hancock said.
Instead, when a hospital and insurer can't agree on a price, the two parties will have to work it out — without ever billing the patient.
"There is still the ability to negotiate," Hancock said. "You didn't have government determining what the price was or determining what the settlement was."
But not all Texans will be protected by the new law. The Texas law does not apply to people who work for large employers whose plans are regulated by the federal government. In Texas, federally regulated plans account for roughly 40% of the state's health insurance market.
In fact, Drew Calver would have been exempt from the state's protections because until recently he had a self-funded health plan regulated by the federal government. However, Drew is now part of wife Erin's health plan, which will be subject to these new protections.
Pogue said people who have federally regulated health plans will be protected only if Congress acts. She predicted the state's action will spur federal lawmakers.
"Texas passing a bill will really help on that front," she said. "There were five states, I think, in 2019 that passed bills that fully protected consumers — and every nudge like that is going to help Congress move."
Texas lawmakers passed separate legislation that could help Texans with federally regulated plans. Senate Bill 1037 prevents a surprise medical bill from affecting someone's credit, regardless of what health insurance plan they have.
Congressional leaders have said they are working on coming up with a fix for people across the country with federally regulated plans. President Donald Trump also recently held an event at the White House, with Drew and Erin Calver standing by his side, announcing his administration's support for banning surprise medical billing in the country.
The committee's chairman, Austin Democrat Lloyd Doggett, said that "federal action is essential" to addressing the issue for many Americans with federally regulated plans. He said he plans to continue to push for legislation that will "finally offer some relief to patients." However, no legislation has been passed, yet.
During his opening statements, Doggett said there is a bipartisan desire to shield patients from surprise bills, but "conflict remains over how to resolve insurer-provider disputes."
This story is part of a partnership that includes KUT, NPR and Kaiser Health News.
Experts caution that as ECMO becomes more available, it is also being used as a last-ditch attempt to buy more time for dying patients with poor chances of survival.
This article was first published on Tuesday, June 18, 2019 inKaiser Health News.
The latest miracle machine in modern medicine — whose use has skyrocketed in recent years — is saving people from the brink of death: adults whose lungs have been ravaged by the flu; a trucker who was trappedunderwater in a crash; a man whose heart had stopped working for an astonishing seven hours.
But for each adult saved by this machine — dubbed ECMO, for extracorporeal membrane oxygenation — another adult hooked up to the equipment dies in the hospital. For those patients, the intervention is a very expensive, labor-intensive and unsuccessful effort to cheat death.
ECMO, the most aggressive form of life support available, pumps blood out of the body, oxygenates it and returns it to the body, keeping a person alive for days, weeks or months, even when their heart or lungs don't work.
The invention is creating "an entirely new paradigm," said Dr. Kenneth Prager, director of clinical ethics at Columbia University Irving Medical Center. "You have a heart that's not working, yet the patient is not dead."
Most commonly used for newborns, ECMO use has been growing dramatically among adults. In the United States, procedures tripled from 2008 to 2014, up to an estimated 6,890, according to the federal Agency for Healthcare Research and Quality.
Experts caution that as ECMO becomes more available, it is also being used as a last-ditch attempt to buy more time for dying patients with poor chances of survival.
ECMO is not designed to be a destination, but a bridge to somewhere — recovery, transplantation or an implanted heart device. But when patients are too sick to reach those goals, ECMO can become a "bridge to nowhere," leaving the patient in limbo, possibly even awake and alert, but with no chance of survival outside the intensive care unit. Medical teams and families can be fiercely divided over when to pull the plug.
ECMO is very expensive, mostly due to the labor involved: A person on ECMO cannot live outside the ICU and must be continuously monitored for complications, such as blood clots, bleeding, infection and loss of blood to the limbs. Median charges for ECMO in 2014 were $550,000, making it the 15th-most-costly procedure that year, according to the AHRQ.
In one recent case, a teaching hospital charged $4.2 million for a 60-day ECMO stay for a 19-year-old man with acute respiratory distress syndrome who was comatose the entire time and did not survive, according to Dr. Merrit Quarum, CEO and founder of WellRithms, a cost-containment company. Quarum said a self-insured health plan is covering the bill.
The number of U.S. hospitals offering ECMO has more than doubled from 108 in 2008 to 264 today, according to a registry run by the Extracorporeal Life Support Organization (ELSO), which tracks most but not all programs.
"In the United States, the competition between hospitals is so intense that every hospital wants the ability to provide this level of care," said Randy Bartilson, president of the ECMO Advantage consulting firm.
But "as ECMO expands, there's still a lot of places that still don't fully understand what it can do and how to use it," he said.
Four patient stories highlight the promise — and complexities — of this game-changing technology.
The Seven-Hour Code
Dr. Jessica Zitter was working in the ICU in an Oakland, Calif., hospital one day when she got summoned for a code blue. A 60-year-old patient had arrived with a heart attack. His heart went into ventricular fibrillation, where it just wiggled like "a bag of worms," she said.
Hospital staff started pumping their palms on the man's chest and put a tube in his throat to help him breathe. Every so often, they stood back and zapped his heart with an electric shock. It didn't work. So, they strapped onto his chest a LUCAS machine, which automatically performs chest compressions like a jackhammer.
The man's oxygen levels were plummeting. At the same time, Zitter recalled, he kept moving, giving her the feeling there was a life to be saved. The medical team decided to go to the next level: ECMO. Everyone waited, with the jackhammering compressions still going, as an ECMO team scrambled to get there from another hospital across the city.
Zitter watched in awe as the ECMO team from the University of California-San Francisco got to work. They stuck one huge tube in a femoral artery and one in a femoral vein. As they pumped his blood out, it was black from deoxygenation. But after it ran through the ECMO machine, she recalled, it transformed into a bright red.
Once on ECMO, the patient didn't need his heart, so it could sit idle and recover. Zitter watched as oxygen returned to his body and brain. He was whisked back to UCSF.
Zitter, who has written about the overuse of modern technology to prolong death, wasn't optimistic. The patient had coded, with people and machines ramming his failing heart, for an astonishing seven hours before ECMO arrived. But as she kept tabs on the patient, she was amazed to learn that he was able to recover and go home.
The case was a "big shocker," Zitter said.
But it was "a crazy, crazy, crazy outlier case with a crazy, crazy, crazy outlier response," she cautioned. "When these kinds of things happen, people tend to look at them and assume that they will have the same odds. The reality is that they won't."
When patients receive ECPR (ECMO for cardiopulmonary resuscitation), only 29% make it out of the hospital alive, according to international statistics from ELSO. Survival rates are higher for people who use ECMO for only the lungs (59%) or only the heart (42%), according to ELSO.
Saving 'Santa'
A more common outcome for ECPR looks something like what Dr. Haider Warraich of Duke University Medical Center came across three or four years ago during his cardiology training.
Warraich was called to the waiting area of a lung transplant clinic, where a man in his 60s had collapsed on the floor due to a heart attack. The man, who had white hair and a scraggly beard, played Santa every Christmas, Warraich later learned. "Santa" — as Warraich refers to him in his upcoming book, "State of the Heart" — had received a new set of lungs after his were wrecked by smoking and lung disease.
The man's heart, starved of oxygen, sped up into a malignant rhythm. CPR and electric shocks didn't bring it back. Motivated to save not only the patient but the new set of lungs he had received, the team called in ECMO.
The ECMO squad arrived with catheters "the size of small javelins," Warraich recalled. Once Santa was hooked up on ECMO, the exhausted CPR team could stop. Cardiologists did surgery on a blocked artery, but they never got his heart back to normal. The man lingered for a month, using ECMO for his heart, a ventilator for his lungs and dialysis for his kidneys, before he died.
In this case, using ECMO felt appropriate, Warraich said. But he said doctors need more guidance to determine which patients would benefit the most and to prevent overuse.
"If you have someone who is dying in front of you, it's really hard to step back and think about it," he said.
The technology, developed in the 1970s, was initially used primarily for newborns. Early clinical trials in adults were discouraging. But in 2009, the CESAR trial in the United Kingdom showed positive results for ECMO in adults with severe respiratory failure. Those findings, combined with improved technology and an epidemic of swine flu, prompted a swift growth of ECMO among adults. The average age for U.S. adults receiving ECMO is 51, one study found. About 1 in 10 ECMO cases are for people over 65.
Warraich and other experts say they are now concerned that new organ-donation rules may inadvertently spur hospitals to place more patients on ECMO: Under guidelinesapproved by the Organ Procurement and Transplantation Network last October, patients on ECMO jump to the front of the heart transplant waiting list.
An 'Unbearable' Choice
Once a patient is on ECMO, deciding when to stop can cause moral distress and division among medical staff, said Dr. Robert Truog, director of the Center for Bioethics at Harvard Medical School.
In one case Truog described in The Lancet, a 17-year-old boy came to the ICU at Boston Children's Hospital, where Truog works as a physician. The boy, who had already had one lung transplantation for cystic fibrosis, was now in end-stage respiratory failure. The only way to save his life was to give him another set of lungs. He started on ECMO as a bridge therapy while he awaited transplantation.
The boy was fully conscious, doing homework, texting friends and visiting with family. But after two months of living in the ICU, he was diagnosed with untreatable cancer that made him ineligible to receive new lungs.
Clinicians were deeply divided over what to do next, Truog said. Some wanted to stop ECMO immediately because its original goal — a bridge to transplantation — was no longer possible.
Others argued that even though he couldn't survive outside the ICU, the boy seemed to have a good quality of life on ECMO, and his family and friends "derived benefits from his continued survival," Truog wrote. They argued that the family should have the right to continue this form of life support, just as with dialysis, ventilation or an artificial heart.
A third argument arose, Truog said: If leaving this patient on ECMO was appropriate, then in fairness "why don't we put everyone with respiratory failure on ECMO?"
For the parents, Truog said, it was "unbearable" to choose a day or moment to turn off ECMO, because they knew their child would immediately die.
Clinicians devised an alternative the family would agree to: They decided not to replace the ECMO oxygenator, a part that needs to be changed every week or two when it develops blood clots. After about a week, the oxygenator gradually failed and the patient lost consciousness and died, Truog said.
The solution "allowed him to die in a way where we didn't feel like we were choosing the moment of his death," he said.
The solution was not optimal, Truog said. But "no matter how you do this, it's going to be very emotionally upsetting to everyone. These are the cases that make some people leave the profession because they're so hard."
A Long Goodbye
Karen Ayoub had never heard of ECMO until her husband became direly ill.
Philip Ayoub, 58, an accountant and former comptroller for the National Football League, was a "huge personality" and a family man; the couple raised twin boys in Greenwich, Conn. Heart disease, which ran in his family, hit him early: He had his first coronary bypass surgery at age 30 and his second at 43, she said.
"He knew that his life might be foreshortened" and "tried to pack as much living into it as possible," said Karen Ayoub, 55. Her husband told her he didn't want any extraordinary lifesaving measures — he was happy with the life he had lived, she said.
In December 2017, he had a third bypass surgery at a hospital on Long Island, and it didn't go well. His heart was weaker than anticipated. He became unconscious, and it wasn't clear if he would ever wake up. He was transferred to Columbia University Irving Medical Center, which has an ECMO program.
Karen Ayoub said it was a fairly easy decision to put her husband on ECMO: "I thought he deserved any chance possible to recover," she said. But she didn't know how he'd react.
"I wasn't sure if he was going to wake up and say, 'Why did you do this? I didn't want any of this!'" she recalled.
When her husband regained consciousness, he mouthed the words: "Why am I here?"
He remained in the ICU for two months, on a feeding tube, breathing tube, ECMO and dialysis. His time there was not easy, she said: Her husband, who had endured a series of mini-strokes during the bypass surgery, began to experience post-traumatic stress disorder, night terrors and side effects from medications.
The only option for further treatment, she said, was to get an implanted device that would help his heart pump. But as he weighed that decision, and the quality of life he would have, the window of time closed when he was eligible for the device, Karen Ayoub said.
When further treatment became out of reach, it was clear her husband was going to die.
"His body was failing him," Karen Ayoub said. "It was time."
She said the two months in the ICU felt like "a gift," because she and her children got to spend extra time with her husband.
"I'll always love you, I'll always be with you," he told his wife over and over during that time.
She said she would make the same choice again to initiate ECMO, but "I don't know about him — he was the one laying in that bed for two months, being tortured by needles and night visions."
After they ran out of treatment options, the family gave permission for the hospital to discontinue life support. Philip wasn't afraid, she said: As his final day approached, he told her, "I can't wait to see what comes next."
Philip was sedated before ECMO was turned off. Karen Ayoub laid her head on her husband's chest and held his hands as he died.
"It was peaceful and respectful," she said, "exactly what he wanted."
'Futile' Care
While the Ayoub family bravely accepted their fate, other families can't bring themselves to let go, said Dr. Shunichi Nakagawa, a palliative care doctor at Columbia who cared for Philip Ayoub.
Some ECMO patients have severe, irreversible brain damage, can't participate in decision-making and bear no chance of making it out of the hospital alive. For them, ECMO represents "the most extreme form of medical futility," Nakagawa argued in an article he and Prager co-authoredwith a colleague in the journal Circulation. They argue that clinicians should have the authority to end or limit life support in such hopeless cases, even if the family objects.
Whether they can do that depends on where they practice: Laws in states such as Idaho, Oklahoma and New York make it difficult to withdraw life-sustaining treatment like ECMO without consent from patients or their families, said Thaddeus Mason Pope, director of the Health Law Institute at Mitchell Hamline School of Law in St. Paul, Minn. But in states like California, Texas and Virginia, clinicians may withdraw ECMO without consent, he said.
Dr. Robert Bartlett, a pioneer of the ECMO field and professor emeritus at the University of Michigan, said he trains doctors that once ECMO becomes a bridge to nowhere, they should tell the family, "We talked about futility, and now we're there. So we're going to turn the circuit off tomorrow."
"It's extremely discourteous to the family to ask the family what to do," he said.
At Cedars-Sinai Medical Center in Los Angeles — where patients with poor chances of survival were being put on ECMO, and families were getting conflicting messages about the potential benefit — staff launched an improvement effort that has created more consensus and consistency around appropriate ECMO care, according to Dr. Michael Nurok, medical director of the cardiac surgery ICU.
At the University of Southern California's Keck Hospital, every family of an ECMO patient meets weekly with palliative care and other clinicians to talk about goals of care — conversations that have been "transformative" for families, said Dr. Sunita Puri, medical director of palliative medicine and supportive care.
In Boston, Dr. Daniela Lamas, a critical care doctor at Brigham and Women's Hospital, said she has seen ECMO's promise and its limitations.
"With every escalation and fancy machine comes a lot of hope," Lamas said. "It's really hard to temper that hope with the realities that with each new thing comes a host of ethical questions and dilemmas."
ECMO, she said, is "a fantastic example of 'just because you can, doesn't mean you should.'"
Spinal surgery made it possible for Liv Cannon to plant her first vegetable garden.
"It's a lot of bending over and lifting the wheelbarrow and putting stakes in the ground," the 26-year-old said as she surveyed the tomatillos, cherry tomatoes and eggplant growing in raised beds behind her house in Austin, Texas. "And none of that I could ever do before."
For as long as she could remember, Cannon's activities were limited by chronic pain and muscle weakness.
"There was a lot of pain in my legs, which I can now recognize as nerve pain," she said. "There was a lot of pain in my back, which I thought was, you know, just something everybody lived with."
Cannon saw many doctors over the years. But they couldn't explain what was going on. She'd pretty much given up on finding an answer for her pain until her fiancé, Cole Chiumento, pushed her to try one more time.
"It never improved, it never got better," Chiumento said. "That just didn't sound right to me."
So about two years ago, Cannon went to a specialist, who ordered a scan of her spine. A few days later, her phone rang.
"We found something on your MRI," a voice said.
The images showed that Cannon had been born with diastematomyelia, a rare disorder related to spina bifida. It causes the spinal cord to split in two.
In Cannon's case, the disorder also led to a tumor that trapped her spinal cord, causing it to stretch as she grew.
In December 2017, a neurosurgeon opened her spinal column and operated for several hours, freeing the cord.
"I think it was day three after my surgery I could feel the difference," Cannon said. "There was just a pain that wasn't there anymore."
As she recovered, Cannon saw lots of huge medical bills go by. They were all covered by her insurance plan. Almost a year had passed since the operation.
Then a new bill came.
Patient: Liv Cannon, 26, of Austin, Texas. At the time of her surgery, she was a graduate student insured with Blue Cross and Blue Shield of Texas through her job at the University of Texas.
Total bill: $94,031 for neuromonitoring services. The bill was submitted to Blue Cross and Blue Shield of Texas, which covered $815.69 of the amount and informed her she was responsible for the balance. The insurer covered all of Cannon's other medical bills, which came to more than $100,000, including those from the hospital, surgeon and anesthesiologist.
Service provider: Traxx Medical Holdings LLC, an Austin company that provides neuromonitoring during spinal surgery. Neuromonitoring uses electrical signals to detect when a surgeon is causing damage to nerves.
Medical service: Cannon was born with a rare spinal condition that had caused chronic pain and muscle weakness since she was a child. In December 2017, she had successful spinal surgery to correct the problem. Her surgeon requested neuromonitoring during the operation.
What gives: Neuromonitoring made sense for the type of surgery Cannon had. The bill did not. Cannon should have been warned long before her surgery that the neuromonitoring company would be an out-of-network provider whose fees might not be covered by her insurer.
At first, she was baffled by the billing information Blue Cross sent her. "It was one of those things from the insurance company that says this is the amount we cover and this is the amount you might owe your provider," she said, referring to her explanation of benefits.
The statement listed four separate charges from the day of her surgery. Each was described as a "diagnostic medical exam." Together, they came to $94,031.
Blue Cross said the covered amount was $815.69 — minus a $750 deductible and $26.27 for coinsurance — and informed Cannon she might have to pay the balance: $93,991.58.
"I was shocked," she said. Chiumento was outraged.
"As soon as I saw that, I thought it was a scam," he said.
The charge came from Traxx Medical Holdings LLC, an Austin company. Traxx did not respond to emails, phone calls and a fax seeking comment on the charge.
The company's websiteshows that Traxx provides a service called intra-operative neuromonitoring, which evaluates the function of nerves during surgery. The goal is to help a surgeon avoid causing permanent damage to the nervous system.
There is an ongoing debate about whether neuromonitoring is needed for all spinal surgery. But it is standard for a complicated operation like the one Cannon had, said Rich Vogel, president of the American Society of Neurophysiological Monitoring.
On the other hand, a $94,000 charge for the service can't be justified, Vogel said.
"You're not going to meet anybody who believes that a hundred thousand dollars or more is reasonable for neuromonitoring," Vogel said.
Most neuromonitoring companies charge reasonable fees for a valuable service and are upfront about their ownership and financial arrangements, he said. But some companies are greedy and submit huge bills to an insurance company, hoping they won't be challenged, he added.
Even worse, "some neuromonitoring groups charge excessive fees in order to gain business by paying the money back to surgeons," Vogel said.
Last year, Vogel's group published aposition statement condemning these "kickback arrangements" and other unethical business practices.
It is unclear whether Traxx has any financial arrangements with surgeons. Cannon's surgeon did not respond to requests for comment.
The size of the fee for Cannon's monitoring was only part of the problem. The other part was that Traxx — unlike her hospital, doctor and anesthesiologist — had no contract with Blue Cross and Blue Shield of Texas. As an out-of-network provider, the company could set its fees and try to collect from Cannon any amount it didn't get from her insurer.
Blue Cross and Blue Shield of Texas said it doesn't comment on problems affecting individual members. But the insurer did offer a general statement by email about the problem:
"Unfortunately, non-contracted providers can expose our members to significantly greater out-of-pocket costs. These charges often have no connection to underlying market prices, costs or quality. If given the opportunity, we will try to negotiate with the provider to reduce the cost."
One thing working against Cannon is that she is pretty sure that, just before surgery, she signed a paper that authorized the out-of-network neuromonitoring.
"It was 4:30 in the morning and you're like, 'OK, let's get this over with,'" she recalled.
Getting consent in the hospital may be legal, but it's not reasonable, said Dr. Arthur Garson Jr., who directs the Health Policy Institute at the Texas Medical Center in Houston.
For example, a patient might be having a heart attack, Garson said. "You got chest pain, you're sweating, sick as you can be, and they hand you a piece of paper and they say, 'Sign here.'"
The Texas Legislature passed a bill in May to protect patients from the sky-high bills this practice can produce. And Congress is considering similar legislation.
These are small steps in the right direction, Garson said.
"Asking the individual patient to make that decision even when they're not sick I think is difficult," he said, "and maybe we ought to think of some better way to do it."
The Texas legislation is expected to take effect later this year but affects only bills that occur after it becomes law. So that $94,000 figure is never far from Cannon's mind, even as she and Chiumento plan their wedding.
"Every time I go out and I collect the mail, I'm wondering, 'Is this the day it's going to show up and we're going to have to deal with this?'" she said.
The Takeaway: Neuromonitoring during complex surgery involving the spine can help prevent inadvertent damage. But monitoring may be unnecessary for lower-risk back operations, like spinal fusion.
It is odd that neuromonitoring is charged as a separate service, rather than part of the spine surgery. Cardiac monitoring is not charged separately during bypass surgery, for example.
When considering spine surgery, ask your doctor whether neuromonitoring will be part of the procedure. If so, will it be billed separately? Try to find out the name of the provider and get an estimate of the cost beforehand.
Check with your insurer to determine if the neuromonitoring provider is within your network and to make sure the estimated charge would be covered.
Bill of the Month is a crowdsourced investigation by Kaiser Health News and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!
In April 2018, 9-year-old Christian Bolling was hiking with his parents and sister in Virginia's Blue Ridge Mountains, near their home in Roanoke. While climbing some boulders, he lost his footing and fell down a rocky 20-foot drop, fracturing both bones in his lower left leg, his wrist, both sides of his nose and his skull.
A rescue squad carried him out of the woods, and a helicopter flew him to a pediatric hospital trauma unit in Roanoke.
Most of Christian's care was covered by his parents' insurance. But one bill stood out. Med-Trans, the air ambulance company, was not part of the family's health plan network and billed $36,000 for the 34-mile trip from the mountain to the hospital. It was greater than the cost of his two-day hospitalization, scans and cast combined.
"When you're in that moment, you're only thinking about the life of your child," said Christian's mother, Cynthia Bolling, an occupational therapist. "I know that I am being taken advantage of. It's just wrong."
The rising number of complaints about surprise medical bills is spurring efforts on Capitol Hill and at the White House to help consumers. Over and over again, the high cost associated with air ambulance service gives patients the biggest sticker shock — the subject has come up at nearly every Capitol Hill hearing and press conference on surprise medical bills.
Yet air ambulance costs are not addressed in any of the proposals introduced or circulating in Congress. Even a congressional decision last year to set up a panel that would study air ambulance billing hasn't gotten off the ground.
"We're doing a disservice to patients if we protect them from hospital bills but bankrupt them on the way there," said James Gelfand, senior vice president for health policy for the ERISA Industry Committee, known as ERIC, a trade association for large employers.
The issue came up again Wednesday at a House Energy and Commerce subcommittee hearing where Rick Sherlock, president and CEO of the Association of Air Medical Services, the industry group for air ambulances, was among eight witnesses.
Rep. Ben Ray Luján (D-N.M.) sharply questioned Sherlock why costs for air ambulance services have risen by 300 percent in his state since 2006.
"I'm trying to get my hands around why this is costing so much and why so many of my constituents are being hit by surprise bills," Luján said.
Sherlock said that reimbursements from Medicare and Medicaid do not cover the cost of providing services, so charges to private patients must make up that difference.
Air ambulances serve more than 550,000 patients a year, according to industry data, and in many rural areas air ambulances are the only speedy way to get patients to trauma centers and burn units. As more than 100 rural hospitals have closed around the country since 2010, the need has increased for air services.
More than 80 million people can get to a Level 1 or 2 trauma center within an hour only if they're flown by helicopter, according to Sherlock.
The service, though, comes at a cost. According to a recent report from the Government Accountability Office, two-thirds of the more than 34,000 air ambulance transports examined were not in the patients' insurance networks. That can leave patients on the hook for the charges their insurers don't cover, a practice known as "balance billing."
In 2017, GAO found that the median price charged nationally by air ambulance providers was around $36,400 for helicopter rides and even higher for other aircraft. The total generally includes the costs for both the transportation and the medical care aboard the aircraft.
Additionally, the ongoing "Bill of the Month" investigativeseries by Kaiser Health News and NPR has received more than a dozen such bills, ranging from $28,000 to $97,000.
Cynthia Bolling said her insurance company paid about a third of Christian's air ambulance bill and the family settled this week with Med Trans by agreeing to pay $4,400 out-of-pocket.
Reid Vogel, director of marketing and communications for Med Trans, said the company cannot talk about a private patient because of privacy rules. But he added that the company works with patients to find "equitable solutions" when their bills are not covered by insurance.
Since nearly three-quarters of flights are for patients insured by low-paying Medicare, Tricare and Medicaid, he said, "providers must shift costs to insured patients."
Private insurers usually will pay only an amount close to what Medicare reimburses, which is around $6,500. That gives air ambulance companies an incentive to remain out-of-network, according to a 2017 GAO report.
"A representative from a large independent provider noted that being out of network with insurance is advantageous to the provider because a patient receiving a balance bill will ask for a higher payment from the insurance company, which often results in higher payment to the air ambulance provider than having a pre-negotiated payment rate with the insurer," the GAO said.
In an interview, Sherlock, of the trade association, disputed the report's findings, saying his members are actively trying to be in-network in more places, although he couldn't provide any specific numbers.
"I think that everywhere they can, they're incentivized to be in-network," he said.
States are hampered in their efforts to ease the strain for residents.
The Airline Deregulation Act of 1978, which was intended to encourage more competition, forbids states to regulate prices for any air carrier, which applies to air ambulances. What's more, many large employers' health insurance is not governed by states but regulated by the federal labor law, known as ERISA.
So a remedy likely has to come from Congress. And it's proven to be a heavy lift.
For example, the committees that deal with regulation of the air industry — the Commerce Committee in the Senate and the Transportation Committee in the House — don't make health policy or regulate health insurance.
Last year, some lawmakers sought to let states regulate air ambulances with a provision in the bill reauthorizing the Federal Aviation Administration.
But that measure was ultimately eliminated. Instead, the bill called for the creation of an advisory committee to study air ambulance prices and surprise bills.
"The air ambulance lobby did a very good job playing defense during FAA authorization," said ERIC's Gelfand.
The panel, which was supposed to be formed within 60 days of the law's enactment date — Oct. 5 — still has not been created.
Representatives from the air ambulance industry don't think congressional action is necessary, although they are calling for higher reimbursements from Medicare.
Chris Eastlee, vice president for government relations for the Association of Air Medical Services, said his group does not favor more congressional regulation of prices but would support mandatory disclosure of costs to the secretary of Health and Human Services. The organization argues that greater transparency will help companies negotiate more in-network contracts.
A fix for surprise bills supported by some researchers and advocates would require every provider within a medical facility to accept any insurance plan that contracts with that hospital. It might also help bring down air ambulance bills, said Loren Adler, associate director of USC-Brookings Schaeffer Initiative for Health Policy.
It would avoid the situation where someone picks an in-network hospital only to find out that a surgeon or anesthesiologist at that hospital doesn't take their insurance. Air transport should also be included in the rule, he said.
"It's the exact same situation as with the out-of-network emergency facility rates," Adler said. "The same solutions should apply."
Gelfand suggested also that the House Ways and Means Committee mandate that air ambulance companies seeking to participate in Medicare must charge in-network rates.
That would require only a small tweak of the legislative language, as he sees it. "Every proposal that includes something to address surprise bills for emergency care, all you have to do is add in the words 'air ambulances,'" Gelfand said.
Right now, the closest any surprise billing proposal has come to addressing air ambulances is a draft legislative plan on medical costs from Sen. Lamar Alexander (R-Tenn.) and Sen. Patty Murray (D-Wash.). They would require bills for air ambulance trips to be itemized to show both medical charges and the transportation charges so patients and health plans can understand them better.
The man was out of his wheelchair and lay flat on his back just off San Francisco's Market Street, waiting for the hypodermic needle to pierce his skin and that familiar euphoric feeling to wash over him.
The old-timer, who appeared to be in his 60s, could not find a viable vein, so a 38-year-old man named Daniel Hogan helped him. Hogan, a longtime drug user originally from St. Louis, leaned over the older man, eyeing his neck as he readied a syringe loaded with the powerful synthetic opioid fentanyl.
Hogan called the man a "jellyfish" because most of his veins had collapsed from years of intravenous drug use and he rarely bled when pricked. But the older guy still had his jugular vein, and for Hogan that would work just fine.
Hogan's hands were pink and swollen, bearing scars and scabs from years of daily drug use and the harshness of life on the streets. But those hands were skilled in the art of street phlebotomy. He slid the needle into the man's neck and pushed the plunger.
Hogan, who said he had taken fentanyl every day for the past two months, explained that he'd developed a tolerance for the drug, and the dose he gave himself would kill a less experienced user. So, he gave the older man only a fraction of that amount.
In case it was too much, Hogan was ready with a vial of naloxone, the overdose-reversal drug.
Grim drug scenes like this play out every day on the streets surrounding San Francisco's Civic Center — an area that spans the hard-luck sidewalks of the Tenderloin district and the transitional Mid-Market neighborhood, home to tech titans Twitter and Uber.
The area has become a beachhead for fentanyl, which has killed tens of thousands across the United States and is beginning to make itself felt in California.
The drug, which can shut down breathing in less than a minute, became the leading cause of opioid deaths in the United States in 2016. It is increasingly sought out by drug users, who crave its powerful high.
They feel a measure of security because many of their peers carry naloxone, which can quickly restore their breathing if they overdose.
Data suggests that in San Francisco the users may be reversing as many overdoses as paramedics — or more. In both cases, numbers have risen sharply in recent years.
In 2018, San Francisco paramedics administered naloxone to 1,647 people, up from 980 two years earlier, according to numbers from the city's emergency response system.
That compares with 1,658 naloxone-induced overdose reversals last year by laypeople, most of them drug users, according to self-reported data from the DOPE Project, a Bay Area overdose prevention program run by the publicly funded Harm Reduction Coalition. That's nearly double the 2016 figure.
"People who use drugs are the primary witnesses to overdose," said Eliza Wheeler, the national overdose response strategist for the coalition. "So it would make sense that when they are equipped with naloxone, they are much more likely to reverse an overdose."
The widespread availability of naloxone has radically changed the culture of opioid use on the streets, Hogan said. "In the past, if you OD'd, man, it was like you were really rolling the dice." Now, he said, people take naloxone for granted.
"I feel like as long as there is Narcan around, the opiates can't kill you," said Nick Orlick, 26, referring to one of the brand names for the overdose reversal drug.
As he huddled in the recess of a building along Mission Street, around the corner from high-rise luxury apartments, Orlick explained that he'd been revived with naloxone 15 times in recent years.
Despite fentanyl's growing presence in San Francisco and other parts of California, it has not hit the Golden State nearly as hard as the rest of the country.
In 2017, 28,466 people across the U.S. died from overdoses involving synthetic opioids, which include fentanyl and related compounds, according to data from the Kaiser Family Foundation. California, which represents 12% of the country's population, had 536 of those deaths — fewer than 2% of the total. (Kaiser Health News, which produces California Healthline, is an editorially independent program of the foundation.)
However, use of fentanyl is likely to grow in San Francisco and Los Angeles, as people get accustomed to it and begin to prefer its more intense high, said Ricky Bluthenthal, professor of preventive medicine at the Keck School of Medicine of the University of Southern California, who researches injection drug use.
In California, as in many other states west of the Mississippi, heroin is smuggled in the form of a gooey or hard black tar. This "black tar" heroin, "a well-known garbage drug," is diluted with fillers, which induces some users to seek out the much more powerful effects of fentanyl, said Kristen Marshall, manager of the DOPE Project.
Fentanyl is dangerous not only because it is up to 50 times more potent than heroin, but also because people often take it unknowingly when their dealers mix it in with street drugs such as heroin. However, the black tar is difficult to mix with fentanyl, and that may help protect drug users who might otherwise ingest it unwittingly, experts say.
But even if they overdose on fentanyl, it's not necessarily a death sentence. The widespread practice by community organizations in San Francisco and Los Angeles of distributing naloxone to the drug-using population also helps explain California's lower rate of deaths from fentanyl and other opioids, harm reduction workers and researchers say.
On the streets around San Francisco's Civic Center, homeless drug users gather on sidewalks with their dogs, some huddling under blankets to smoke their white, powdered fentanyl through hollowed-out pens. Others inject it, often ducking into alcoves, alleys or tents for a fleeting moment of privacy amid the bustle of government employees, tourists and tech workers. Some of them overdose in plain sight.
They employ various methods to reduce the overdose risk. Some, like Daniel Hogan, take methamphetamine or smoke crack between injections to keep themselves alert. Another technique is to delay the full dose by pushing the plunger only partway down.
If gathered as a group, they often stagger their fentanyl use so one of them will be physically able to administer naloxone.
One recent May afternoon near Market Street, a thin man in his early 40s who called himself Bud slid a needle into his arm and slowly pushed the plunger down, stopping every so often to gauge the effects of the fentanyl.
"Hey, stop there. Pull it out," said his friend Seth Carus, 55. Bud's eyes were vacant and his mouth drooped — telltale signs the fentanyl had taken hold.
Bud, wearing tight clothing and a blue beret, didn't listen. He pushed the plunger all the way. Five minutes later, the color drained from his face, his eyes opened wide, his jaw locked and his entire body went stiff as he lay on the sidewalk.
Carus, living on the streets and a fentanyl user himself, sprang into action. He prepared a shot of naloxone and told a bystander to call 911.
But before Carus could administer the overdose reversal drug, Bud began to stir. Carus cradled him in his arms as the police arrived, followed quickly by the paramedics, who put Bud in an ambulance.
Carus blamed himself as he bent over and cried. The fentanyl was his, and he had been trying to do Bud a favor by getting him high.
A while later, Bud emerged from the ambulance and embraced his friend. "You did the right thing, man," he told Carus. "I did the shitty drug addict thing. You said to stop, and I didn't listen."
A new Trump administration proposal would change the civil rights rules dictating whether providers must care for patients who are transgender or have had an abortion. Supporters of the approach say it protects the freedom of conscience, but opponents say it encourages discrimination.
The sweeping proposal has implications for all Americans, though, because the Department of Health and Human Services seeks to change how far civil rights protections extend and how those protections are enforced.
Roger Severino, the director of the HHS Office for Civil Rights, has been candid about his intentions to overturn an Obama-era rule that prohibited discrimination based on gender identity and termination of a pregnancy. In 2016, while at the conservative Heritage Foundation, he co-authored a paper arguing the restrictions threaten the independence of physicians to follow their religious or moral beliefs.
His office unveiled the proposed rule on May 24, when many people were focused on the start of the long Memorial Day holiday weekend.
The rule is the latest Trump administration proposal to strip protections for transgender Americans, coming the same week another directivewas proposed by the Department of Housing and Urban Development that would allow homeless shelters to turn away people based on their gender identity.
The public was given 60 days to comment on the HHS proposal. Here's a rundown of what you need to know about it.
What would this proposal do?
Fundamentally, the proposed rule would overturn a previous rule that forbids healthcare providers who receive federal funding from discriminating against patients on the basis of their gender identity or whether they have terminated a pregnancy.
The Trump administration proposal would eliminate those protections, enabling providers to deny these groups care or insurance coverage without having to pay a fine or suffer other federal consequences.
That may mean refusing a transgender patient mental healthcare or gender-confirming surgery. But it may also mean denying patients care that has nothing to do with gender identity, such as a regular office visit for a bad cold or ongoing treatment for chronic conditions like diabetes.
"What it does, from a very practical point of view, is that it empowers bad actors to be bad actors," Mara Keisling, executive director of the National Center for Transgender Equality, told reporters.
The proposal would also eliminate protections based on sexual orientation and gender identity from several other healthcare regulations, like non-discrimination guidelines for the healthcare insurance marketplaces.
Does it affect only LGBTQ people?
The proposal goes beyond removing protections for the LGBTQ community and those who have had an abortion.
It appears to weaken other protections, such as those based on race or age, by limiting who must abide by the rules. The Trump proposal would scrap the Obama-era rule's broad definition of which providers can be punished by federal health officials for discrimination, a complicated change critics have said could ease requirements for insurance companies, for instance, as well as the agency itself.
And the proposal erases many of the enforcement procedures outlined in the earlier rule, including its explicit ban on intimidation or retaliation. It also delegates to Severino, as the office's director, full enforcement authority when it comes to things like opening investigations into complaints lodged under the non-discrimination rule.
Why did HHS decide to change the rule?
The Obama and Trump administrations have different opinions about whether a healthcare provider should be able to refuse service to patients because they are transgender or have had an abortion.
It all goes back to a section in the Affordable Care Act barring discrimination on the basis of race, color, national origin, age, disability or sex. President Barack Obama's health officials said it is discrimination to treat someone differently based on gender identity or stereotypes.
It was the first time Americans who are transgender were protected from discrimination in healthcare.
But President Donald Trump's health officials said that definition of sex discrimination misinterprets civil rights laws, particularly a religious freedom law used to shield providers who object to performing certain procedures, such as abortions, or treating certain patients because they conflict with their religious convictions.
"When Congress prohibited sex discrimination, it did so according to the plain meaning of the term, and we are making our regulations conform," Severino said in a statement. "The American people want vigorous protection of civil rights and faithfulness to the text of the laws passed by their representatives."
Much of what the Office for Civil Rights has done under Severino's leadership is to emphasize and strengthen so-called conscience protections for healthcare providers, many of which existed well before Trump was sworn in. Last year, Severino unveiled a Conscience and Religious Freedom Division, and his office recently finalized another rule detailing those protections and their enforcement.
The office also said the proposed rule would save about $3.6 billion over five years. Most of that would come from eliminating requirements for providers to post notices about discrimination, as well as other measures that cater to those with disabilities and limited English proficiency.
The rule would also save providers money that might instead be spent handling grievances from those no longer protected.
The office "considers this a benefit of the rule," said Katie Keith, co-founder of Out2Enroll, an organization that helps the LGBTQ community obtain health insurance. "Organizations will have lower labor costs and lower litigation costs because they will no longer have to process grievances or defend against lawsuits brought by transgender people."
Why does this matter?
Research shows the LGBTQ community faces greater health challenges and higher rates of illness than other groups, making access to equitable treatment in healthcare all the more important.
Discrimination, from the misuse of pronouns to denials of care, is "commonplace" for transgender patients, according to a 2011 report by advocacy groups. The report found that 28% of the 6,450 transgender and gender non-conforming people interviewed said they had experienced verbal harassment in a healthcare setting, while 19% said they had been refused care due to their gender identity.
The report said 28% had postponed seeking medical attention when they were sick or injured because of discrimination.
Critics fear the rule would muddy the waters, giving patients less clarity on what is and is not permissible and how to get help when they have been the victims of discrimination.
Jocelyn Samuels, the Obama administration official who oversaw the implementation of the Obama-era rule, said that for now, even though the Trump administration's HHS will not pursue complaints against those providers, Americans still have the right to challenge this treatment in court. Multiple courts have said the prohibition on sex discrimination includes gender identity.
"The administration should be in the business of expanding access to healthcare and health coverage," Samuels told reporters on a conference call after the rule's release. "And my fear is that this rule does just the opposite."
PORTLAND, Ore. — After nearly 40 years as an internist, Dr. Ron Naito knew what the sky-high results of his blood test meant. And it wasn't good.
But when he turned to his doctors last summer to confirm the dire diagnosis — stage 4 pancreatic cancer — he learned the news in a way no patient should.
The first physician, a specialist Naito had known for 10 years, refused to acknowledge the results of the "off-the-scale" blood test that showed unmistakable signs of advanced cancer. "He simply didn't want to tell me," Naito said.
A second specialist performed a tumor biopsy, and then discussed the results with a medical student outside the open door of the exam room where Naito waited.
"They walk by one time and I can hear [the doctor] say '5 centimeters,'" said Naito. "Then they walk the other way and I can hear him say, 'Very bad.'"
Months later, the shock remained fresh.
"I knew what it was," Naito said last month, his voice thick with emotion. "Once [tumors grow] beyond 3 centimeters, they're big. It's a negative sign."
The botched delivery of his grim diagnosis left Naito determined to share one final lesson with future physicians: Be careful how you tell patients they're dying.
Since August, when he calculated he had six months to live, Naito has mentored medical students at Oregon Health & Science University and spoken publicly about the need for doctors to improve the way they break bad news.
"Historically, it's something we've never been taught," said Naito, thin and bald from the effects of repeated rounds of chemotherapy. "Everyone feels uncomfortable doing it. It's a very difficult thing."
Robust research shows that doctors are notoriously bad at delivering life-altering news, said Dr. Anthony Back, an oncologist and palliative care expert at the University of Washington in Seattle, who wasn't surprised that Naito's diagnosis was poorly handled.
"Dr. Naito was given the news in the way that many people receive it," said Back, who is a co-founder of VitalTalk, one of several organizations that teach doctors to improve their communication skills. "If the system doesn't work for him, who's it going to work for?"
Up to three-quarters of all patients with serious illness receive news in what researchers call a "suboptimal way," Back estimated.
"'Suboptimal' is the term that is least offensive to practicing doctors," he added.
The poor delivery of Naito's diagnosis reflects common practice in a country where Back estimates that more than 200,000 doctors and other providers could benefit from communication training.
Too often, doctors avoid such conversations entirely, or they speak to patients using medical jargon. They frequently fail to notice that patients aren't following the conversation or that they're too overwhelmed with emotion to absorb the information, Back noted in a recent article.
"[Doctors] come in and say, 'It's cancer,' they don't sit down, they tell you from the doorway, and then they turn around and leave," he said.
That's because for many doctors, especially those who treat cancer and other challenging diseases, "death is viewed as a failure," said Dr. Brad Stuart, a palliative care expert and chief medical officer for the Coalition to Transform Advanced Care, or C-TAC. They'll often continue to prescribe treatment, even if it's futile, Stuart said. It's the difference between curing a disease and healing a person physically, emotionally and spiritually, he added.
"Curing is what it's all about and healing has been forgotten," Stuart said.
The result is that dying patients are often ill-informed. A 2016 study found that just 5% of cancer patients accurately understood their prognoses well enough to make informed decisions about their care. Another study found that 80% of patients with metastatic colon cancer thought they could be cured. In reality, chemotherapy can prolong life by weeks or months, and help ease symptoms, but it will not stop the disease.
Without a clear understanding of the disease, a person can't plan for death, Naito said.
"You can't go through your spiritual life, you can't prepare to die," Naito said. "Sure, you have your [legal] will, but there's much more to it than that."
The doctors who treated him had the best intentions, said Naito, who declined to publicly identify them or the clinic where they worked. Reached for verification, clinic officials refused to comment, citing privacy rules.
Indeed, most doctors consider open communication about death vital, research shows. A 2018 telephone survey of physicians found that nearly all thought end-of-life discussions were important — but fewer than a third said they had been trained to have them.
Back, who has been urging better medical communication for two decades, said there's evidence that skills can be taught — and that doctors can improve. Many doctors bridle at any criticism of their bedside manner, viewing it as something akin to "character assassination," Back said.
"But these are skills, doctors can acquire them, you can measure what they acquire," he said.
It's a little like learning to play basketball, he added. You do layups, you go to practice, you play in games and get feedback — and you get better.
For instance, doctors can learn — and practice — a simple communication model dubbed "Ask-Tell-Ask." They ask the patient about their understanding of their disease or condition; tell him or her in straightforward, simple language about the bad news or treatment options; then ask if the patient understood what was just said.
Naito shared his experience with medical students in an OHSU course called "Living With Life-Threatening Illness," which pairs students with ill and dying patients.
"He was able to talk very openly and quite calmly about his own experience," said Amanda Ashley, associate director of OHSU's Center for Ethics in Healthcare. "He was able to do a lot of teaching about how it might have been different."
Alyssa Hjelvik, 28, a first-year medical student, wound up spending hours more than required with Naito, learning about what it means to be a doctor — and what it means to die. The experience, she said, was "quite profound."
"He impressed upon me that it's so critical to be fully present and genuine," said Hjelvik, who is considering a career as a cancer specialist. "It's something he cultivated over several years in practice."
Naito, who has endured 10 rounds of chemotherapy, recently granted the center$1 million from the foundation formed in his name. He said he hopes that future doctors like Hjelvik — and current colleagues — will use his experience to shape the way they deliver bad news.
"The more people know this, it doesn't have to be something you dread," he said. "I think we should remove that from medicine. It can be a really heartfelt, deep experience to tell someone this, to tell another human being."
Spravato maker Janssen provided the FDA modest evidence that it worked and only in limited trials. It presented no information about the use of Spravato beyond 60 weeks.
This article was first published on Tuesday, June 11, 2019 in Kaiser Health News.
Ketamine is a darling of combat medics and clubgoers, an anesthetic that can quiet your pain without suppressing breathing and a hallucinogenic that can get you high with little risk of a fatal overdose.
For some patients, it also has dwelled in the shadows of conventional medicine as a depression treatment — prescribed by their doctors, but not approved for that purpose by the federal agency responsible for determining which treatments are "safe and effective."
That effectively changed in March, when the Food and Drug Administration approved a ketamine cousin called esketamine, taken as a nasal spray, for patients with intractable depression. With that, the esketamine nasal spray, under the brand name Spravato, was introduced as a miracle drug — announced in press releases, celebrated on the evening news and embraced by major healthcare providers like the Department of Veterans Affairs.
The problem, critics say, is that the drug's manufacturer, Janssen, provided the FDA at best modest evidence it worked and then only in limited trials. It presented no information about the safety of Spravato for long-term use beyond 60 weeks. And three patients who received the drug died by suicide during clinical trials, compared with none in the control group, raising red flags Janssen and the FDA dismissed.
The FDA, under political pressure to rapidly greenlight drugs that treat life-threatening conditions, approved it anyway. And, though Spravato's appearance on the market was greeted with public applause, some deep misgivings were expressed at its day-long review meeting and in the agency's own briefing materials, according to public recordings, documents and interviews with participants, KHN found.
Dr. Jess Fiedorowicz, director of the Mood Disorders Center at the University of Iowa and a member of the FDA advisory committee that reviewed the drug, described its benefit as "almost certainly exaggerated" after hearing the evidence.
Fiedorowicz said he expected at least a split decision by the committee. "And then it went strongly in favor, which surprised me," he said in an interview.
Esketamine's trajectory to approval shows — step by step — how drugmakers can take advantage of shortcuts in the FDA process with the agency's blessing and maneuver through safety and efficacy reviews to bring a lucrative drug to market.
Step 1: In late 2013, Janssen got the FDA to designate esketamine a "breakthrough therapy" because it showed the potential to reverse depression rapidly — a holy grail for suicidal patients, such as those in an emergency room. That potential was based on a two-day study during which 30 patients were given esketamine intravenously.
Step 2: But discussions between regulators and drug manufacturers can affect the amount and quality of evidence required by the agency. In the case of Spravato, they involved questions like, how many drugs must fail before a patient's depression is considered intractable or "treatment-resistant"? And how many successful clinical trials are necessary for FDA approval?
Step 3: Any prior agreements can leave the FDA's expert advisory committees hamstrung in reaching a verdict. Fiedorowicz abstained on Spravato because, though he considered Janssen's study design flawed, the FDA had approved it.
The expert panel cleared the drug according to the evidence that the agency and Janssen had determined was sufficient. Dr. Matthew Rudorfer, an associate director at the National Institute of Mental Health, concluded that the "benefits outweighed the risks." Explaining his "yes" vote, he said: "I think we're all agreeing on the very important, and sometimes life-or-death, risk of inadequately treated depression that factored into my equation."
But others who also voted "yes" were more explicit in their qualms. "I don't think that we really understand what happens when you take this week after week for weeks and months and years," said Steven Meisel, the system director of medication safety for Fairview Health Services based in Minneapolis.
A Nasal Spray Offers A Path To A Patent
Spravato is available only under supervision at a certified facility, like a doctor's office, where patients must be monitored for at least two hours after taking the drug to watch for side effects like dizziness, detachment from reality and increased blood pressure, as well as to reduce the risk of abuse. Patients must take it with an oral antidepressant.
Despite those requirements, Janssen, part of Johnson & Johnson, defended its new offering. "Until the recent FDA approval of Spravato, healthcare providers haven't had any new medication options," Kristina Chang, a Janssen spokeswoman, wrote in an emailed statement.
Esketamine is the first new type of drug approved to treat severe depression in about three decades.
Although ketamine has been used off-label for years to treat depression and post-traumatic stress disorder, drugmakers saw little profit in doing the studies to prove to the FDA that it worked for that purpose. But a nasal spray of esketamine, which is derived from ketamine and (in some studies) more potent, could be patented as a new drug.
Although Spravato costs more than $4,700 for the first month of treatment (not including the cost of monitoring or the oral antidepressant), insurers are more likely to reimburse for Spravato than for ketamine, since the latter is not approved for depression.
Shortly before the committee began voting, a study participant identifying herself only as "Patient 20015525" said: "I am offering real-world proof of efficacy, and that is I am both alive and here today."
The drug did not work "for the majority of people who took it," Meisel, the medication safety expert, said in an interview. "But for a subset of those for whom it did work, it was dramatic."
Concerns About Testing Precedents
Those considerations apparently helped outweigh several scientific red flags that committee members called out at the hearing.
Although the drug had gotten breakthrough status because of its potential for results within 24 hours, the trials were not persuasive enough for the FDA to label it "rapid-acting."
The FDA typically requires that applicants provide at least two clinical trials demonstrating the drug's efficacy, "each convincing on its own." Janssen provided just one successful short-term, double-blind trial of esketamine. Two other trials it ran to test efficacy fell short.
To reach the two-trial threshold, the FDA broke its precedent for psychiatric drugs and allowed the company to count a trial conducted to study a different topic: relapse and remission trends. But, by definition, every patient in the trial had already taken and seen improvement from esketamine.
What's more, that single positive efficacy trial showed just a 4-point improvement in depression symptoms compared with the placebo treatment on a 60-point scale some clinicians use to measure depression severity. Some committee members noted the trial wasn't really blind since participants could recognize they were getting the drug from side effects like a temporary out-of-body sensation.
Finally, the FDA lowered the bar for "treatment-resistant depression." Initially, for inclusion, trial participants would have had to have failed two classes of oral antidepressants.
Less than two years later, the FDA loosened that definition, saying a patient needed only to have taken two different pills, no matter the class.
Forty-nine of the 227 people who participated in Janssen's only successful efficacy trial had failed just one class of oral antidepressants. "They weeded out the true treatment-resistant patients," said Dr. Erick Turner, a former FDA reviewer who serves on the committee but did not attend the meeting.
Six participants died during the studies, three by suicide. Janssen and the FDA dismissed the deaths as unrelated to the drug, noting the low number and lack of a pattern among hundreds of participants. They also pointed out that suicidal behavior is associated with severe depression — even though those who had suicidal ideation with some intent to act in the previous six months, or a history of suicidal behavior in the previous year, were excluded from the studies.
In a recent commentary in the American Journal of Psychiatry, Dr. Alan Schatzberg, a Stanford University researcher who has studied ketamine, suggested there might be a link due to "a protracted withdrawal reaction, as has been reported with opioids," since ketamine appears to interact with the brain's opioid receptors.
Kim Witczak, the committee's consumer representative, found Janssen's conclusion about the suicides unsatisfying. "I just feel like it was kind of a quick brush-over," Witczak said in an interview. She voted against the drug.
Public health departments are redirecting scarce resources to try to control the spread of measles. Their success relies on shoe-leather detective work.
This article was first published on Monday, June 10, 2019 in Kaiser Health News.
On any given day, more than 4,000 people pass through the library at California State University-Los Angeles.
On April 11, one of them had measles. The building has only one entrance, which means that anyone who entered or exited the library within two hours of that person's visit potentially was exposed to one of the most contagious diseases on Earth.
It's the stuff of public health nightmares: Everyone at the library between 11 a.m. and 3 p.m. that day had to be identified, warned and possibly quarantined. Measles is so contagious that up to 90% of people close to an infected person who are not protected by a vaccine or previous case of the disease will become infected. But how could the university figure out who had been in the library during that time frame? And which of those people were vulnerable to infection?
Rooting out answers to such questions is the job of the public health detectives who work at health departments across the country.
In 2000, the United States declared the measles eradicated, thanks to widespread use of vaccines. But the virulent disease is back, with more than 1,000 cases confirmed nationwide this year through June 3 — the greatest number since 1992. For every thousand cases, 1 to 3 people with measles will die, even with the best of care, according to the Centers for Disease Control and Prevention. So public health departments are redirecting scarce resources to try to control the spread.
Using basic techniques in place for over 100 years, public health investigators work to control an outbreak before it balloons. Such investigations have evolved with new technologies but remain among the best defenses against infectious disease outbreaks — and among the great untold costs of an epidemic.
The New York City Department of Health and Mental Hygiene, which has confirmed 566 measles cases since September, has spent more than $2.3 million on related investigations. The Los Angeles County Department of Public Health estimates spending as much as $2,000 to track down each contact of a confirmed patient — and it has made hundreds of such efforts in recent months.
"Public health departments across the country have had their budgets tightened in a sustained fashion over the past 15 years," said Dr. William Schaffner, an infectious-disease specialist at Vanderbilt University. "There are no public health departments that are like firemen playing pinochle and waiting for an outbreak. They have other things to do, and they have to put aside those tasks to deal with an outbreak."
Bottom of Form
At Cal State LA, public health officials visited the library and tried to figure out exactly where the infected student had gone — the photocopy area, for example — to determine who might have been exposed. They worked with the school to identify which library employees were present. They scoured library records to find anyone who had checked out books or logged onto a library computer during the specified time period.
But they realized they were missing others who may have come in to browse, work or eat at a library cafe. So, school officials sent out emails and posted on Facebook, Twitterand Instagramto ask anyone who may have been at the library to come forward.
Working together, Cal State and county health officials came up with a list of 1,094 people who were exposed; all were required to present proof they had been vaccinated or had immunity.
At one point during the investigation, 887 people were under a blanket quarantine order from the Los Angeles County Department of Public Health until they could establish their immunity status.
Public health departments regularly employ this sort of shoe-leather detective work to track and control outbreaks of sexually transmitted diseases and foodborne illnesses like salmonella. But there is a palpable sense of frustration that sets the measles apart: It is easily preventable.
"We shouldn't have to be using these ancient techniques. We should have everybody immunized," said Dr. Alan Melnick, director of public health in Clark County, Wash., which logged 71 measles cases during a two-month outbreak that ended in February. "That's what keeps me up at night. If we stop vaccinating, we can turn the clock back to the Middle Ages."
In the course of Clark County's outbreak, 237 people spent 19,071 hours doing outreach, investigation and monitoring the health of people exposed, at a cost of more than $864,000. They investigated 53 exposure sites, including 15 schools and the arena where the Portland Trail Blazers play just across the state line in Oregon.
All this work meant delays in other programs, including restaurant health inspections and a home-visit program for high-risk pregnant women and infants.
"Just because the measles outbreak is going on, it doesn't mean other communicable diseases are taking a holiday," Melnick said.
There was a time public health officials wouldn't have bothered. Before the late 19th century, officials "were busy trying to control diseases like typhoid, cholera and smallpox," which had much higher death rates than measles, said Graham Mooney, an associate professor at Johns Hopkins University who studies the history of medicine. But as other infectious diseases declined, officials focused more intently on measles.
By the early 20th century, schools began noting which students had already had the measles, and who might be vulnerable. When a child fell ill, he might be sent home with a card to be signed by a physician before he could return. A school medical inspector often would visit the home to make sure the child remained isolated.
During an epidemic involving thousands of cases, officials placed warnings in newspapers and later on the radio, describing likely symptoms and asking parents to keep sick children at home. "Now it's Twitter; before, it would have been The Baltimore Sun or the Chicago Tribune or the L.A. Times. But the actual information may not have changed," said Mooney.
Today, public health departments almost invariably learn of a measles case through a healthcare provider. Measles is a reportable disease, which means that any provider who suspects a case has to warn local health officials. Someone from the department visits the patient to conduct an interview and determine precisely where they might have gone while contagious. For the measles, that's four days before the rash appears, and four days after, for a total of nine days.
The interviews are rigorous. "We have to assess their hangouts, their friends, their hobbies, which grocery store do they go to, do they take Lyft or Uber?" explained L.A. County public health nurse Adarsh Almalvez.
For most people, it's hard to remember everywhere they went days earlier. Some patients are reluctant to share details. Almalvez said she starts by building a rapport, asking them about their favorite foods and where they get their hair cut. She said it's crucial to get the patient's cooperation.
She looks for clues around the house that could tell her who else might be living there. Extra pairs of shoes in the hallway, for example, might indicate other residents. If she's interviewing a woman and finds the toilet seat up, she knows a man likely has been there as well.
The goal is to come away with a list of all possible contacts and locations the patient visited while contagious. The results can read like a bizarrely intimate window into one person's day. L.A. County recentlypublished a patient's itinerary in April; in one enviable day, that patient visited Peet's Coffee, Fratelli Café, TART restaurant, The Grove, the Los Angeles Farmers Market, Whole Foods and the La Brea Tar Pits.
Public health officials visit each site to gather more information. They reach out to ride-sharing services to locate drivers and other passengers who might have been in the same car during the infectious period. At restaurants, employees are easily identified, but customers can be hard to find. Officials don't routinely look at surveillance video or track down people through credit card receipts. Instead, they mainly rely on news releases and social media to spread the word. They also look to schools and businesses to do outreach.
This can be a lot of work, especially for medical clinics where a measles patient initially sought care. During a 2017 outbreak, Children's Minnesota, a hospital system in the Twin Cities, spent $300,000 on their emergency response. Part of that was tracking down everyone in the waiting room within two hours of a measles patient.
Patsy Stinchfield, who directs the Children's Minnesota's infection prevention and control program, has worked on three measles outbreaks, in 1989, 2011 and 2017. She said the work has gotten more efficient because of electronic health records and the state's electronic vaccination registry. With the click of a few buttons, investigators can determine who was in the waiting room with a measles patient, and which people were unvaccinated.
Still, Stinchfield said, measles outbreaks remain a source of great frustration. "If we can get people to use the [measles] vaccine, we won't have to spend all these healthcare dollars, all of this time and energy on follow-up," she said. "And we won't have to have all these miserable, sick children."
In a program called My Life, My Story, volunteer writers seek out vets at the VA hospitals, ask them all about their lives, and write up a thousand-word biography.
This story was first published on Monday, June 10, 2019 in Kaiser Health News.
Bob Hall was recovering from yet another surgery in March 2014 when a volunteer walked into his hospital room. It had been a rocky recovery since his lung transplant three months earlier at the William S. Middleton Memorial Veterans Hospital in Madison, Wis.
The volunteer wasn't there to check on his lungs or breathing. Instead, she asked Hall if he wanted to tell his life story.
Hall served in the Marine Corps during the Vietnam War. After the war, he had a political career as a Massachusetts legislator, and then led professional associations for 30 years.
"I'm anything but a shy guy, and I'm always eager to share details about my life," Hall said, half-jokingly.
Hall, who was 67, spoke to the volunteer for over an hour about everything from his time as a D student in high school ("I tell people I graduated in the top 95% of my class") to his time in the military ("I thought the Marines were the toughest branch and I wanted to stop the communists"). He finished with the health problems that finally landed him in the hospital, and brought him to the present day.
The interview was part of a program called My Life, My Story. Volunteer writers seek out vets at the hospital like Hall, and ask them all about their lives. Then they write up a thousand-word biography, and go over it with the patient, who can add more details or correct any mistakes.
"Of course, being a writer I rewrote the whole thing," Hall confessed with a smile.
When the story is finished, it's attached to the patient's electronic record, where a doctor or nurse working anywhere in the Veterans Affairs medical system can read it.
Today more than 2,000 patients at the Madison VA have shared their life stories.
Project organizers say it could change the way providers interact with patients.
Personalizing Impersonal Medical Records
Clinicians can access a lot of medical data through a patient's electronic medical record, but there's nowhere to learn about a patient's personality or learn about her career, passions or values, said Thor Ringler, who has managed the My Life, My Story project since 2013.
"If you were to try to get a sense of someone's life from that record, it might take you days," Ringler said.
The idea for My Life, My Story came from Dr. Elliot Lee, a medical resident who was doing a training rotation at the Madison VA in 2012. The typical rotation for medical residents lasts only about a year, so Lee wanted to find a way to bring new, young doctors up to speed on the VA patients. He wanted a way for them to absorb not just their health histories, but more personal pieces of knowledge.
"It seemed to make sense that the patient might know a lot about themselves, and could help provide information to the new doctor," Lee said.
Lee and colleagues tried having patients fill out surveys, which were useful but still left the team wanting more. Next, they tried getting patients to write down their life stories themselves, but not many people really wanted to.
Finally, an epiphany: hire a writer to interview patients, and put it all down on paper.
It wasn't hard to find a good candidate: There was a poet in Madison, Thor Ringler, who had just finished his training as a family therapist. He was good at talking to people, and also skilled at condensing big thoughts into concise, meaningful sentences.
"I applied for it," Ringler said. "I was like, 'Well, of course! I was made for that!'"
Under Ringler's guidance, the project has developed a set of training materials to allow other VA hospitals to launch storytelling programs. About 40 VA hospitals around the country are currently interested, according to Ringler.
In California, there's a program at the Fresno VA, and volunteers at the Los Angeles VA are scheduled for training this summer.
Ringler estimates hospitals would need to hire just one writer — working half or full time, depending on the hospital's size — to manage a similar storytelling program. That means the budget could be as low as $23,000 a year.
The program aims to address a perennial patient complaint that Ringler summed up this way: "I don't get to see anybody for very long, and nobody [at the hospital] knows who I am."
In addition to the interest from within the VA system, the idea has spread farther, to hospitals like Brigham and Women's Hospital in Boston and Regions Hospital in St. Paul, Minn.
A 'Gift' To Doctors And Nurses
There is research that suggests when caregivers know their patients better, those patients have improved health outcomes.
One study found that doctors who scored higher on an empathy test have patients with better-controlled blood sugar. Another study found that in patients with a common cold, the cold duration was nearly a full day shorter for those patients who gave their doctor a top rating for empathy.
University of Colorado assistant professor Heather Coats studies the health impact of biographical storytelling. She notes that a 2008 study found striking improvement in care when radiologists were simply provided with a photo of the patients whose scans they were reading.
"They improved the accuracy of their radiology read," Coats said, "meaning less misspelled words, a better report that's more detailed." Current research is investigating whether storytelling might have a similar effect on clinical outcomes.
And, Coats said, the benefits of the kind of storytelling happening at the VA don't just accrue for the patients' benefit.
"I consider it a gift to the nurses and the doctors who are caring for the patient," she said.
A survey of clinicians conducted by the Madison VA backed that up: It showed 85% of clinicians thought reading the biographies of patients produced by Thor Ringler's team of writers was "a good use" of clinical time and also helped them improve patient care.
"It gives you a much better understanding about the entirety of their life and how to help them make a decision," said Dr. Jim Maloney, the surgeon who performed Bob Hall's lung transplant in 2013.
Maloney says knowing more about a patient's life story makes it easier for the doctor to have difficult but necessary conversations with a patient — to learn, for example, how aggressively to respond if a complication occurs.
Maloney says the stories generated by My Life, My Story let the entire transplant team connect quickly with patients and family members, and start conversations about sensitive issues or difficult choices about end-of-life care.
Dr. Tamara Feingold-Link, a second-year medical resident at Brigham and Women's Hospital in Boston, first spotted a My Life, My Story biography when she was on rotation at a Boston-area VA.
When her attending physician asked Feingold-Link to run a meeting with a patient she barely knew — a man who was so sick he could hardly talk — his story became a powerful tool.
"It brought me to tears," she said. "When I met his family, I could connect with them immediately."
"It made his transfer to hospice much smoother for everyone involved," she said.
Now Feingold-Link has started a similar program at Brigham and Women's Hospital.
Beyond Medical Care
Hall has learned the stories can be meaningful to caregivers even when they're not working. During one of his stays at the Madison VA, a nursing aide stopped by for a visit.
"She came in one night and sat down on my bed just to talk to me for a while because she'd read my story," Hall said. "I found out later she wasn't on the clock."
It's been five years since Hall's lung transplant, and he's doing well. He even found a part-time job putting his writing skills to work as part of the My Life, My Story team. In two years, Hall has written 208 capsule biographies of veterans.
This story is part of a partnership that includes Wisconsin Public Radio, NPRand Kaiser Health News.