Seven years ago, Robert Kerley, who makes his living as a truck driver, was loading drywall when a gust of wind knocked him off the trailer. Kerley fell 14 feet and hurt his back.
For pain, a series of doctors prescribed him a variety of opioids: Vicodin, Percocet and OxyContin.
In less than a year, the 45-year-old from Federal Heights, Colo., said he was hooked. "I spent most of my time high, laying on the couch, not doing nothing, falling asleep everywhere," he said.
Kerley lost weight. He lost his job. His relationships with his wife and kids suffered. He remembers when he hit rock bottom: One night hanging out in a friend's basement, he drank three beers, and the alcohol reacted with an opioid.
"I was taking so much morphine that I [experienced] respiratory arrest," Kerley said. "I stopped breathing."
An ambulance arrived, and EMTs administered the overdose reversal drug naloxone. Kerley was later hospitalized. As the father of a 12-year-old boy, he knew he needed to turn things around. That's when he signed up for Kaiser Permanente's integrated pain service. (Kaiser Health News is not affiliated with Kaiser Permanente.)
"After seven years of being on narcotics and in a spiral downhill, the only thing that pulled me out of it was going to this class," he said. "The only thing that pulled me out of it was doing and working the program that they ask you to work."
The program he refers to is an eight-week course, available to Kaiser Permanente members in Colorado for $100. It's designed to educate high-risk opioid patients about pain management. A recent class met at Kaiser's Rock Creek medical offices in Lafayette, Colo., a town east of Boulder. Will Gersch, a clinical pharmacy specialist, taught several patients learning to battle addiction the science behind prescription drugs.
"So, basically the overarching message here is the higher the dose of the opioids, the higher the risk," he told the group, as he jotted numbers on a whiteboard. "If you're over these two doses, that's a risk factor."
Amanda Bye, a clinical psychologist, works as part of an integrated medical team to treat people with chronic pain. (John Daley/Colorado Public Radio)
Upstairs, Gersch's colleague Amanda Bye, a clinical psychologist, highlighted a key element of the program: It's integrated. For patient care, there's a doctor, a clinical pharmacist, two mental health therapists, a physical therapist and a nurse — all on one floor. Patients can meet with this team, either all at once or in groups, but they do not have to deal with a series of referrals and appointments in different facilities. A spokesperson for Kaiser Permanente said researchers tracked more than 80 patients over the course of a year and found the group's emergency room visits decreased 25 percent. Inpatient admissions dropped 40 percent, and patients' opioid use went way down.
"We brought in all these specialists. We all know the up-to-date research of what's most effective in helping to manage pain," Bye said. "And that's how the program got started."
Bye said the team helps patients use alternatives like exercise, meditation, acupuncture and mindfulness. Some patients, though, do need to go to the chemical dependency unit for medication-assisted treatment for their opioid addiction. Benjamin Miller is an expert on integrated care with the national foundation Well Being Trust. Kaiser is on the right track, he said.
"The future of health care is integrated and, unfortunately, our history is very fragmented, and we're just now catching up to developing a system of care that meets the needs of people," he said.
Similar projects in California showed a reduction in the number of prescriptions and pills per patient, said Dr. Kelly Pfeifer, director of high-value care at the California Health Care Foundation. Her group released case studies of three programs similar to Kaiser's Colorado program. (Kaiser Health News produces California Healthline, an editorially independent publication of the California Health Care Foundation.)
"We've seen great success with these models that are integrating complementary therapy, physical therapy, behavioral health and medical care," Pfeifer said. A key strategy is to gradually decrease the amount of opioids a patient takes, rather than cut them off before they're ready. "It works so much better when the patients have access to these complementary therapies," she said. "And it works even better when those complementary therapies are part of an integrated team."
But it can be difficult to implement universally. One challenge is scale: Big systems like Kaiser Permanente have ample resources and enough patients to make the effort work. Another issue is payment. Some insurers won't pay for some alternative treatments; others have separate payment streams for different kinds of care.
"Frequently, behavioral health and medical health are paid for by entirely different systems," Pfeifer said.
Robert Kerley is recovering from an opioid addiction with help from Kaiser Permanente's pain management program in Colorado. (John Daley/Colorado Public Radio)
The need for programs like Kaiser's is urgent. In 2016, a record 912 people died from an overdose in Colorado, according to data recently released by the state health department. Of those, 300 people died from an opioid overdose. Opioid use often leads to an addiction to heroin, which claimed another 228 lives last year in the state. Those two causes together now rival the number of deaths from car accidents in the state.
Colorado faces a severe shortage of treatment options. Making matters worse, the state's largest substance abuse treatment provider, Arapahoe House, decided to close as of Jan. 2.
Kaiser's integrated pain service has given some patients a second chance.
Robert Kerley, now a veteran of the program, recently shared his story with other patients. "I got my life back. I can sleep. I can eat. I can enjoy things," Kerley told them.
To cope with pain, Kerley starts his morning with stretching and a version of tai chi that he calls "my chi." He practices deep breathing. His advice to others suffering from pain or addiction?
"Do whatever it takes to walk away from it, like no matter what," Kerley said. "Trust me, it gets better. It gets 100 percent better than where you're at right now."
Better for Kerley means his relationships with his family have improved. And he's back at work, once again able to make a living as a truck driver.
When a hepatitis C treatment called Harvoni was released in 2014, Dr. Ronald Cirillo knew it was a big deal.
"It"s the reason that dragged me out of retirement!" he said.
Cirillo specialized in treating hepatitis C for more than 30 years in Stamford, Conn., before retiring to Bradenton, Fla. During his time in Connecticut, the only available treatment for hepatitis C had terrible side effects and didn"t work well. It cured the viral infection less than half the time. But the newer drugs, Harvoni and Sovaldi, cure almost everybody, with few adverse reactions.
"In my lifetime, I"ve seen it change from a horrible treatment to a manageable treatment," Cirillo says.
His mission is finding the patients.
"The disease is out there," he said. "My job is to get the disease in here, so we can follow them and treat them."
Last year, Cirillo joined the Turning Points free clinic in Bradenton, about an hour south of Tampa. The clinic primarily serves uninsured Floridians who fall into what many call a coverage gap in states like Florida that chose not to expand Medicaid. These are people who make less than about $12,000 a year.
Cirillo is trying to test every high-risk patient he encounters. On a recent weekday in the clinic, his assistant pricked a patient"s finger, and squeezed blood onto the end of a small plastic tube.
"And this little measuring tool goes into the blood and solution mix there," Cirillo said. "We are going to time it — 20 minutes and that"s it. That"s the test."
Nearly 30,000 people in Florida were found to have hepatitis C in 2016. It"s likely that many more are infected, because the virus can lie dormant for decades.
Cirillo spearheaded a partnership with Harvoni"s maker, Gilead Sciences, and that partnership has provided treatment to about 100 patients.
"We treat people without any insurance, that have no hope," Cirillo said."If you qualify to be a patient here, you"ll get tested."
A 57-year-old patient named Patricia discovered she had hepatitis C a few months ago during a trip to the clinic. NPR and Kaiser Health News are not using her last name because the virus is sometimes associated with illegal IV drug use. It can also spread via sex. Patricia said she"s not sure how she got it.
"So, just because of my age, I guess, they went ahead and tested me for it and it blew my mind that I actually had hep C," she said. "And the levels ended up being relatively high."
The virus had started to scar and inflame her liver. But she lacked insurance and a job; the $94,000 Harvoni treatment would have been out of reach if she hadn"t had financial help from the drugmaker.
"I would never have been able to afford that treatment," she said. "Never."
Staff at the clinic help patients fill out the complicated application from Gilead. Only patients who don"t have insurance, have been drug-free for at least six months and who meet income requirements are eligible.
Patricia was able to get the treatment — one pill a day for 12 weeks — and will be tested again in three months to determine whether she is free of hepatitis C.
"Had they not discovered it and gotten me onto the program — really, who knows?" she said.
They cite several reasons, including low public awareness, heavy workloads, fear that they won't be adequately paid and reluctance to treat drug-addicted people.
Gale Dunham, a pharmacist in Calistoga, Calif., knows the devastation the opioid epidemic has wrought, and she is glad the anti-overdose drug naloxone is becoming more accessible.
But so far, Dunham said, she has not taken advantage of a California law that allows pharmacists to dispense the medication to patients without a doctor’s prescription. She said she plans to take the training required at some point but has not yet seen much demand for the drug.
“I don’t think people who are heroin addicts or taking a lot of opioids think that they need it,” Dunham said. “Here, nobody comes and asks for it.”
In the three years since the California law took effect, pharmacists have been slow to dispense naloxone, which reverses the effects of an overdose. They cite several reasons, including low public awareness, heavy workloads, fear that they won’t be adequately paid and reluctance to treat drug-addicted people.
In 48 states and Washington, D.C., pharmacists have flexibility in supplying the drug without a prescription to patients, or to their friends or relatives, according to the National Alliance of State Pharmacy Associations. But as in California, pharmacists in many states, including Wisconsin and Kentucky, have divergent opinions about whether to dispense naloxone.
“The fact that we don’t have wider uptake … is a public health emergency in and of itself,” said Virginia Herold, executive officer of the California State Board of Pharmacy. She said both pharmacists and the public need to be better educated about the drug.
Pharmacists are uniquely positioned to identify those at risk and help save the lives of patients who overdose on opioids, said Talia Puzantian, a pharmacist and associate professor of clinical sciences at Keck Graduate Institute School of Pharmacy in Claremont, Calif.
“There’s a Starbucks on every corner. What else is on every corner? A pharmacy. So we are very accessible,” Puzantian told a group of pharmacy students recently as she trained them on providing naloxone to customers. “We are interfacing with patients who may be at risk. We can help reduce overdose deaths by expanding access to naloxone.”
Talia Puzantian, associate professor of clinical sciences at Keck Graduate Institute School of Pharmacy in Claremont, Calif., teaches students about naloxone, which reverses the effects of an opioid overdose. Puzantian got a federal grant to teach more pharmacists around California about naloxone. (Ivan Alber/Keck Graduate Institute)
Opioid overdoses killed 2,000 people in California and 15,000 nationwide in 2015.
Naloxone can be administered via nasal spray, injection or auto-injector. Prices for it vary widely, but insurers often cover it. The drug binds to opioid receptors, reversing the effect of opioids and helping someone who has overdosed to breathe again.
At least 26,500 overdoses were reversed from 1996 to 2014 because of naloxone administered by laypeople, according to the National Institute on Drug Abuse. Since then, the drug has become much more widely available among first responders, law enforcement officers and community groups. The drug is safe and doesn’t have serious side effects, apart from putting someone into immediate withdrawal, according to the institute.
Information on how many pharmacists are dispensing naloxone is limited, but one study last year showed access to the drug at retail pharmacies increased significantly from 2013 to 2015 from previously small numbers.
Interviews and available evidence from around the U.S. indicate that pharmacists have varying perspectives. In Kentucky, for example, one study found that 28 percent of pharmacists surveyed were not willing to dispense naloxone.
In Pennsylvania, pharmacists weren’t exactly lining up to hand out naloxone when the state passed a law in 2015 allowing them to do it, said Pat Epple, CEO of the Pennsylvania Pharmacists Association. She said there were some initial obstacles, including the cost of the drug and pharmacists’ limited awareness of the law. The association worked with state health officials to raise awareness of naloxone among patients and pharmacists and reduce the stigma of dispensing it, Epple said.
Wisconsin is also among the states that allow pharmacists to dispense naloxone. Sarah Sorum, a vice president at the Pharmacy Society of Wisconsin, said the state’s pharmacists want to expand their public health role and help curb the opioid epidemic. But reimbursement has been a challenge, she said.
Not all health plans across the nation cover the full cost of the drug, and pharmacists also are concerned about getting paid for the time it takes to counsel patients or their relatives.
California and other states require pharmacists to undergo training before they can dispense naloxone to patients who don’t have a doctor’s prescription. Puzantian and others say that in California not enough pharmacists are getting the training, which can be taken online or in person and can cost a few hundred dollars.
So far, the California State Board of Pharmacy has trained between 450 and 500 pharmacists, and the membership-based California Pharmacists Association has added an additional 170. Other smaller organizations offer the naloxone training, according to the association. There are about 28,000 licensed pharmacists in the state.
Once trained, California pharmacists who provide naloxone must screen patients to find out if they have a history of opioid use. They also must counsel people requesting the drug on how to prevent, recognize and respond to an overdose.
Some say training requirements are an unnecessary barrier, especially given the high level of education already required to become a pharmacist.
Some of the bigger pharmacy chains, including CVS, Rite Aid and Walgreens, have made the drug available without a prescription in the states that allow it. Walgreens has announced that it would stock the nasal spray version of naloxone at all of its pharmacies. It said it offers the drug in 45 states without requiring the patient to have a prescription.
Peter Lurie, president of the Center for Science in the Public Interest, said not every pharmacy has to dispense naloxone for people to have access to it. “But the greater the number of dispensing pharmacies the better,” he said, adding that it is “especially important in more sparsely populated areas.”
Corey Davis, deputy director of the Network for Public Health Law, said making naloxone available over the counter would also increase access, since people could buy it off the shelf without talking to a pharmacist.
Bryan Koschak, a community pharmacist at Shopko in Redding, Calif., said people should go to a hospital or doctor’s office for naloxone. “I am not champing at the bit to do it,” he said. “It is one more thing on my plate that I would have to do.”
Michael Creason, a pharmacist in San Diego expressed a different view. He did the training after his employer, CVS, required it. He said pharmacies are a great vehicle for expanding access to naloxone because patients often develop a rapport with their pharmacists and feel comfortable asking for it.
Pharmacy associations should educate their members about the laws that allow naloxone to be provided without a doctor’s prescription and persuade more of them to provide the drug to customers who need it, Lurie said. Others say more pharmacists should put up signs to make customers aware that naloxone is available in their shops.
The California Pharmacists Association said it is trying to raise awareness through newsletters and emails to pharmacists in the state. “We want to see every pharmacy be able to furnish naloxone and every person at risk have access to it,” said Jon Roth, the association’s CEO.
The state’s pharmacy schools also include the training in their curriculum. One day recently, Puzantian explained to a classroom full of pharmacy students that naloxone is effective, safe and can prevent death.
“You can’t get a dead addict into recovery,” she told the students. Drug users “might have multiple overdoses, but each overdose reversal is a chance for them to get into recovery.”
The searing abdominal pain came on suddenly while Dr. Rana Awdish was having dinner with a friend. Soon she was lying in the back seat of the car racing to Henry Ford Hospital in Detroit, where Awdish was completing a fellowship in critical care.
On that night nearly a decade ago, a benign tumor in Awdish’s liver burst, causing a cascade of medical catastrophes that nearly killed her. She nearly bled to death. She was seven months pregnant at the time, and the baby did not survive. She had a stroke and, over the days and weeks to come, suffered multiple organ failures. She required several surgeries and months of rehabilitation to learn to walk and speak again.
Helpless, lying on a gurney in the hospital’s labor and delivery area that first night, Awdish willed the medical staff to see her as a person rather than an interesting case of what she termed “Abdominal Pain and Fetal Demise.” But their medical training to remain clinically detached worked against her. Later, in the intensive care unit, she overheard her case being discussed by the surgical resident during morning rounds.
“She’s been trying to die on us,” he said. It made her angry, she said, because she was trying desperately not to die. “I felt he was positing me as an adversary. If my care team didn’t believe in me, what possible hope did I have?”
When a benign tumor in Dr. Rana Awdish’s liver burst, it caused a cascade of medical catastrophes that nearly killed her. Her experiences made her rethink how care should be delivered. (Courtesy of Henry Ford Health System)
Awdish survived and returned to her work at Henry Ford Hospital, but her perspective was indelibly altered. In her recently published book, “In Shock,” she describes her through-the-looking-glass experience as a critically ill patient. The ordeal opened her eyes to communication lapses, uncoordinated care and at times a total lack of empathy at an institution that says on its home page that health care there "should be built around just one person: you."
The health system has embraced many of her suggestions for change.
Today, she splits her time working as a critical care physician and as the medical director of care experience for the Henry Ford Health System. In the past five years, she and three colleagues have developed a program to improve empathy and communication with patients, called Clear Conversations. At retreats that typically last two days, Henry Ford Hospital staff practice having difficult conversations with improvisational actors who act as their patients. The program also trains providers in fundamental patient communications skills and offers real-time physician “shadowing” to provide feedback.
Awdish regularly speaks about her work around the country at conferences and medical schools, “trying to capture the students a bit upstream,” she said.
“To listen to our patients with a generous ear does require a willingness to relinquish control of the narrative,” she said in her book. “Our questions allow for the possibility that we do not already know the answers. By not dominating the flow of information, we allow the actual history to emerge.”
Awdish spoke with me recently about her book. The following interview has been edited for length and clarity.*
Q: What about being a patient surprised you?
What surprised me the most about being a critically ill patient was how much what I needed as a patient was different than what as a physician I would have thought I needed. As a physician, I was truly focused on trying to provide the best medical care possible. I thought that meant trying to treat people and bring them back to health as fast as possible, not staying in emotional spaces. As a patient, I realized that someone could treat me but if I didn’t feel they really saw me, that somehow I didn’t feel healed. That emotional space is really where healing occurs.
Q: Through the Clear Conversations program, you’re trying to address the lack of effective communication and empathy you experienced as a patient. Did it help or hinder you that you were bringing this idea to your own hospital?
What helped me in my patient experience was that as much as I saw what was missing, I also saw myself in every failure. And it was very clear that as a physician I was a product of my training. We all are. That removed much of the shame. That very much helped.
Though I believed we were doing this for the patients, what was shocking for me was how valuable the physicians found the training. As physician and author Atul Gawande said, “We all need a coach.” Once we go into practice, where do you go for guidance?
Q: Do the changes really “take” after a two-day workshop?
By immersing departments, by training not only senior staff physicians in how to have these conversations with patients but also their fellows and residents, we gain traction. Because if residents don't see the communication tools valued by their mentors, they won’t value it. And everyone holds each other accountable. Everyone’s ears are attuned to the same thing. It does start to create change in the sense that expectations have changed for everybody.
Q: How is insurance a barrier to change?
The system is not set up to facilitate conversation, to facilitate time spent with patients. It doesn’t facilitate things that are of value. The need to see patients so often to keep up productivity, and the limitations on time because we’re so caught up in electronic medical record charting — all those things pull you away from patients. It’s up to physicians to keep that space sacred against the competing priorities.
Q: Is there anything that patients can do to help connect with a physician?
What I most wish people knew is that while the system is broken, the people are good. The system actually obstructs things like communication and access. So, it’s up to us to figure out the best way to communicate on a one-on-one basis and create that sacred space between ourselves.
The deduction that allows people with very high medical costs to shrink their taxable income by subtracting some out-of-pocket medical expenses was a moving target during the congressional debate this fall.
Patients scored a victory in the tough negotiations over the Republicans’ overhaul of the tax code.
The deduction that allows people with very high medical costs to shrink their taxable income by subtracting some out-of-pocket medical expenses was a moving target during the congressional debate this fall. Some lawmakers wanted to repeal it, but people with serious illnesses or who need long-term care said that eliminating the tax break would be a serious financial blow.
Congress has come around to their way of thinking, at least for now. The tax bill passed this month preserves and expands it.
Under the new law, people whose unreimbursed medical expenses exceed 7.5 percent of their adjusted gross income can claim a deduction for those expenses in 2017 and 2018. Then it is scheduled to revert to 10 percent for everyone, said Tara Straw, a senior policy analyst at the Center on Budget and Policy Priorities, a nonpartisan research institute in Washington, D.C.
That’s a lower threshold than current rules, which had required that people’s medical expenses exceed 10 percent of their income to take the deduction in 2017 if they’re younger than 65. For people 65 or older, the threshold already was set at 7.5 percent.
Yet even at the lower threshold, relatively few people can take the deduction because their medical expenses aren’t high enough, Straw said.
To start with, health insurance premiums for employer-sponsored coverage that many people pay for with pretax dollars generally don’t qualify, she said. “For many people, their premium is their biggest medical expense, and for most people, it can’t be deducted as a medical expense.”
In 2015, roughly 8.8 million taxpayers took the medical expense deduction, according to the Internal Revenue Service.
The House version of the tax reform bill eliminated the medical expense deduction, setting off alarm bells among consumer advocates for seniors and others. Lawmakers initially maintained that tax breaks such as the medical expense deduction weren’t necessary because their tax bill would provide so many other overall tax benefits to families.
The Senate version of the bill included the medical expense deduction and moved the threshold to 7.5 percent, at the behest of Sen. Susan Collins (R-Maine), who was concerned about high health care costs for seniors.
For the final bill, lawmakers settled on the Senate version.
Recent revelations that a U.S. researcher injected Americans with his experimental herpes vaccine without routine safety oversight raised an uproar among scientists and ethicists.
Not only did Southern Illinois University researcher William Halford vaccinate Americans offshore, he injected other participants in U.S. hotel rooms without Food and Drug Administration oversight or even a medical license. Since then, several participants have complained of side effects.
But don’t expect the disclosures after Halford’s death in June to trigger significant institutional changes or government response, research experts say.
“A company, university or agency generally does not take responsibility or take action on their own to help participants, even if they’re hurt in the trial,” said Carl Elliott, a professor in the Center for Bioethics at the University of Minnesota. “These types of cases are really a black hole in terms of accountability.”
The federal government once scrutinized or even froze research at universities after learning of such controversies. Now, experts said, the oversight agencies tend to avoid action even in the face of the most outrageous abuses.
Experts said the U.S. regulatory agencies are especially unprepared to deal with off-the-grid experiments like Halford’s. He recruited subjects through Facebook and in some cases didn’t require signed consent forms, or informed participants outright that the experiments flouted FDA oversight. These patients, many who struggle with chronic, painful herpes, proceeded anyway in their quest for a cure. After Halford’s offshore trial, Peter Thiel, a libertarian and adviser to President Donald Trump, pitched in millions of dollars for future research.
“This is experimentation in the 21st century: heavily embedded in social media and combined with a hostility to regulatory oversight,” said Arthur Caplan, director of the Division of Medical Ethics at New York University’s School of Medicine. “How is the government going to manage subjects, researchers and investors who don’t like regulations?”
SIU officials initially brushed off any questions about Halford’s methods, saying the university did not have responsibility for the offshore vaccinations of the 20 participants in the trial because he formed an independent company to conduct the trial in St. Kitts and Nevis.
SIU eventually launched an inquiry last August, more than a month after Kaiser Health News began asking questions about Halford’s methods. The investigation is ongoing, although a preliminary inquiry found Halford’s methods to be in “serious noncompliance” with university rules and U.S. regulations.
Experts say the university should contact all participants who were injected with the vaccine and offer help to those who are suffering from side effects. But they point out that the university has potential conflicts of interest when scrutinizing its role in Halford’s research. SIU shared in the vaccine patent with Halford’s company, and medical school administration officials touted his work when Rational Vaccines benefited from Thiel’s investment.
In ongoing reporting, KHN learned that Halford injected a group of people in two hotel rooms near his lab in Springfield, Ill., in 2013, three years before he began experiments offshore. According to emails and one of the participants, many email exchanges with participants were sent from Halford’s university email account. He used the university phone and referred to a graduate student as assisting in the experiment and using the lab.
One participant has told the FDA he believes he suffers from adverse effects from the vaccine.
Yet Rational Vaccines continues to assert the vaccine is safe and effective, even though Halford’s data from his human subject experiments have not been published in a reputable scientific journal. Since the controversy, the company has taken down its website.
“This researcher basically violated all of the regulatory requirements and ethical principles guiding human subject research,” said Michael Carome, a doctor who directs the health research group for the nonprofit advocacy group Public Citizen. “Unfortunately, it seems everyone is trying to distance themselves here to avoid legal liability and a public relations embarrassment.”
The FDA, which has declined to comment on this case, could have jurisdiction, but it rarely takes aggressive action on behalf of human subjects, experts said. The FDA has had limited contact with two participants who have filed complaints alleging side effects from the vaccine.
“The FDA is just not set up to handle this,” NYU’s Caplan said.
The federal Office for Human Research Protections (OHRP), which monitors how human subjects are treated in trials, could choose to conduct an independent investigation. The agency would have jurisdiction because the university had pledged to follow human subject safety protocols for all research, even if it was funded privately.
Experts, however, remain skeptical that OHRP, an agency in the Department of Health and Human Services, would assume a prominent role in investigating the case based on the agency’s track record.
OHRP asked the university for an explanation after KHN first reported that Halford didn’t ask for routine safety oversight from an institutional review board.
OHRP once took on human subject violations that occurred during non-federally funded research and in cases where the FDA asserted jurisdiction, Carome said.
Now, the agency often chooses to stay out of non-federally funded trials and defers to the FDA, he said.
As a result, its public response to allegations of research abuse has plummeted, experts said.
The agency’s public assessments of research misconduct peaked in 2002, when it issued more than 100 “determination letters.” That number has steadily declined. This year, it has issued one.
“A single letter in one year is extraordinary,” said Carome, who was the agency’s associate director for regulatory affairs from 2002 to 2010. “OHRP’s compliance oversight activities are moribund.”
“The end result is the federal watchdog for human subject protections is ineffective in its role in investigating complaints” and preventing violations, he said.
OHRP maintains it has been using other “more efficient” approaches. Rather than automatically opening a case and issuing a determination letter, the agency is “working more closely with complainants and institutions to address some of the concerns raised about human subject research,” said an HHS spokesperson, who declined to be named citing agency policy.
“But … in situations where something seriously wrong occurred, or subjects were harmed, OHRP does take action,” the spokesperson said.
OHRP hasn’t taken high-profile, aggressive action in years, said experts who pointed to the government’s suspension of federally funded research at Duke University and Johns Hopkins University more than a decade ago.
The federal government’s unresponsiveness in cases of privately funded research became more pronounced under the Obama administration, experts said.
In the waning days of the Obama administration, the federal government approved the first major overhaul of regulations surrounding human trials in 40 years. The resulting changes to federally funded trials included making consent forms more concise and clear.
Laura Stark, associate professor at Vanderbilt University’s Center for Medicine, Health and Society, said that in federally funded trials the measure “shifts the balance towards protecting research participants rather than protect[ing] institutions against liability.”
However, the rule does not address privately funded trials.
“If [the] organization and studies are privately funded, then they are not beholden to the law,” Stark said
As more universities began dropping their pledges to follow safety protocols for all research, it had already become difficult for the agency to assert jurisdiction. Meanwhile, OHRP’s compliance staff dwindled from six employees in 2008 to two in 2017. The lack of accountability for privately funded research is unlikely to change, experts say.
Stark called Halford’s research “a potential harbinger of the future of medical research given the increase in private funding and the unlikely prospect of updating the regulations again anytime soon.”
Compounding the problem, the United States is the only developed nation that does not guarantee medical care for those injured in clinical trials, experts said.
When participants claim injury, they often are told to file claims with their insurance companies, an impossible endeavor, said NYU’s Caplan.
“We still haven’t figured out how to compensate people who say they are injured in research,” he said. “In cases like these, in which subjects are claiming harm from a cuckoo experiment, the system is set up to punish the institution rather than give redress to the subject. Their only route then is to sue.”
Elena Altemus is 89 and has dementia. She often forgets her children’s names, and sometimes can’t recall whether she lives in Maryland or Italy.
Yet Elena, who entered a nursing home in November, was screened for breast cancer as recently as this summer. “If the screening is not too invasive, why not?” asked her daughter, Dorothy Altemus. “I want her to have the best quality of life possible.”
But a growing chorus of geriatricians, cancer specialists and health system analysts are coming forth with a host of reasons: Such testing in the nation’s oldest patients is highly unlikely to detect lethal disease, hugely expensive and more likely to harm than help since any follow-up testing and treatment is often invasive.
And yet such screening — some have labeled it “overdiagnosis” — is epidemic in the United States, the result of medical culture, aggressive awareness campaigns and financial incentives to doctors.
By looking for cancers in people who are unlikely to benefit, “we find something that wasn’t going to hurt the patient, and then we hurt the patient,” said Dr. Sei Lee, an associate professor of geriatrics at the University of California-San Francisco.
Nearly 1 in 5 women with severe cognitive impairment — including older patients like Elena Altemus — are still getting regular mammograms, according to the American Journal of Public Health — even though they’re not recommended for people with a limited life expectancy. And 55 percent of older men with a high risk of death over the next decade still get PSA tests for prostate cancer, according to a 2014 study in JAMA Internal Medicine.
Among people in their 70s and 80s, cancer screenings often detect slow-growing tumors that are unlikely to cause problems in patients’ lifetimes. These patients often die of something else — from dementia to heart disease or pneumonia — long before their cancers would ever have become a threat, said Dr. Deborah Korenstein, chief of general internal medicine at New York’s Memorial Sloan Kettering Cancer Center. Prostate cancers, in particular, are often harmless.
“It generally takes about 10 years to see benefit from cancer screening, at least in terms of a mortality benefit,” Korenstein said.
Enthusiasm for cancer screenings runs high among patients and doctors, both of whom tend to overestimate the benefits but underappreciate the risks, medical research shows.
In some cases, women are being screened for tumors in organs they no longer have. In a study of women over 30, nearly two-thirds who had undergone a hysterectomy got at least one cervical cancer screening, including one-third who had been screened in the past year, according to a 2014 study in JAMA Internal Medicine.
Even some patients with terminal cancers continue to be screened for other malignancies.
Nine percent of women with advanced cancers — including tumors of the lung, colon or pancreas — received a mammogram and 6 percent received a cervical cancer screen, according to a 2010 study of Medicare recipients over age 65. Among men on Medicare with incurable cancer, 15 percent were screened for prostate cancer.
Although screenings can extend and improve lives for healthy, younger adults, they tend to inflict more harm than good in people who are old and frail, Korenstein said. Testing can lead to anxiety, invasive follow-up procedures and harsh treatments.
“In patients well into their 80s, with other chronic conditions, it’s highly unlikely that they will receive any benefit from screening, and more likely that the harms will outweigh the benefits,” said Dr. Cary Gross, a professor at the Yale School of Medicine.
By screening patients near the end of life, doctors often detect tumors that don’t need to be found and treated. Researchers estimate that up to two-thirds of prostate cancers are overdiagnosed, along with one-third of breast tumors.
“Overdiagnosis is serious,” Gross said. “It’s a tremendous harm that screening has imposed. … It’s something we’re only beginning to reckon with.”
In November, a coalition of patient advocates, employers and others included prostate screenings in men over age 75 in its list of the top five “low-value” medical procedures. Dr. A. Mark Fendrick, co-director of the coalition, referred to the five procedures as “no-brainers,” arguing that health plans should consider refusing to pay for them.
Prostate cancer screening in men over 75 cost Medicare at least $145 million a year, according to a 2014 study in the journal Cancer. Mammograms in this age group cost the federal health plan for seniors more than $410 million a year, according to a 2013 study in JAMA Internal Medicine.
Taxpayers usually foot the bill for these tests, because most seniors are covered by Medicare.
And while cancer screenings generally aren’t expensive — a mammogram averages about $100 — they can launch a cascade of follow-up tests and treatments that add to the total cost of care.
Most spending on unnecessary medical care stems not from rare, big-ticket items, such as heart surgeries, but cheaper services that are performed much too often, according to an October study in Health Affairs.
A Hard Habit To Break
Many older patients expect to continue getting screened, said Dr. Mara Schonberg, an associate professor at Harvard Medical School and Boston’s Beth Israel Deaconess Medical Center.
“It’s jarring for someone who’s been told every year to get screened and then at age 75 you tell them to stop,” she said.
John Randall, 78, says he plans to live into his 90s. He sees no reason to skip cancer screening.
“I, for one, do not like to hear what my life expectancy is,” said Randall, who lives near Madison, Wis. He plans to have his next colonoscopy in January. He feels healthy and walks 2 miles at a stretch several days a week. “No one knows when I am going to die.”
Decades of public awareness campaigns have convinced patients that cancer screenings are essential, said Dr. Lisa Schwartz, a professor at the Dartmouth Institute for Health Policy and Clinical Practice. Her research found that many people see cancer screening as a moral obligation and can’t imagine a day when they would stop getting screened.
Such campaigns have convinced many women that “mammograms saves lives.”
But those campaigns don’t mention that doctors need to screen 1,000 women for a decade in order to prevent one death from breast cancer, said Schonberg.
Yet screenings can have dire consequences. Medical complications during colonoscopies — such as intestinal tears — are almost twice as common in patients ages 75 to 79 compared with those 70 to 74, according to a study published in January in Annals of Internal Medicine.
Colonoscopies, which require extensive bowel cleansing before the procedure, also can leave many older people dehydrated and prone to fainting.
PSA tests can lead to prostate biopsies — in which doctors use needles to sample tissue — that cause infections in about 6 percent of men. These infections send about 1 in 100 men who undergo the procedure to the hospital, according to a 2014 study in the Journal of Urology.
Even removing nonfatal skin cancers can cause problems for older patients, said Dr. Eleni Linos, an associate professor at the University of California-San Francisco School of Medicine. Frail patients can struggle to care for surgical wounds and change dressings; their wounds are also less likely to heal well, Linos said. More than 1 in 4 patients with nonfatal skin cancers report a complication of treatment, Linos’ research shows.
Yet most of the 2.5 million slowest-growing skin cancers found each year are diagnosed in people over 65, according to Linos’ 2014 study. More than 100,000 of these nonfatal skin cancers are treated in patients who die within one year.
Screenings, follow-up tests and treatments can cause emotional trauma as well.
“For a woman of that generation who doesn’t have the cognitive ability to understand what’s going on, having private parts of their body exposed and pressed against a machine can be very agitating and upsetting,” Lee said.
Among older women, about 70 percent report significant stress at the time of a biopsy, Schonberg said. Simply lying on a table for a 45-minute biopsy can cause pain for women with significant arthritis, she said.
Instead of spending time and effort on things that are hurtful and never going to help them, why not direct time and energy on things that will help them live longer and better?
Virtually all older women with breast cancer wind up getting surgery, which poses additional hardships, Schonberg said. Many are prescribed hormonal therapies that can cause bone pain, fatigue and increase the risk of stroke.
With prostate cancer, doctors today try to reduce the harm from overdiagnosis by offering men with early-stage disease “active surveillance” instead of immediate treatment. A study published last year in the New England Journal of Medicine found that men are just as likely to survive 10 years whether they choose to be treated or monitored.
Jay Schleifer, 74, of Wellington, Fla., was diagnosed with a low-risk prostate cancer last year. Since then, his doctor has monitored him with additional tests. He’ll be treated only if tests suggest his cancer has become more aggressive.
This less aggressive approach aims to spare Schleifer from long-term side effects.
Among men who have had prostate cancer surgery, 14 percent lose control of their bladders and 14 percent develop erectile dysfunction, according to a 2013 study in JAMA Internal Medicine.
In a study published in July in the Journal of Clinical Oncology, Dr. Richard Hoffman found 15 percent of prostate cancer survivors regretted their treatment decision. Those treated with surgery and radiation were about twice as likely to regret their choice compared with those who opted to monitor their disease.
Men are more likely to regret their prostate cancer treatment decisions if they don’t understand the risks beforehand, said Hoffman, director of general internal medicine at the University of Iowa Carver College of Medicine/Iowa City VA Medical Center.
Harold Honeyfield, 87, said he didn’t fully understand the risks when he had prostate cancer surgery 12 years ago. Although he is glad he was treated, the surgery caused irreversible erectile dysfunction, which has caused stress and sadness for him and his wife of 47 years.
“When a man has no erections, that is paralysis,” said Honeyfield, of Davis, Calif., who started a support group for other men dealing with prostate cancer. “You’ve lost the ability to be a man.”
A Tough Sell
Doctors have a number of incentives to continue ordering screening tests as people age.
“It’s a lot easier to say, ‘Fine, get your regular mammogram this year,’ than to have the much more difficult conversation that it’s not helpful when life expectancy is limited,” Gross said.
Schonberg said she tries to be diplomatic when talking to patients about halting screening.
In patients well into their 80s, with other chronic conditions, it’s highly unlikely that they will receive any benefit from screening.
“It’s hard to tell people, ‘You’re not going to live long enough to benefit,’” Schonberg said. “That doesn’t go over well.”
Many physicians continue screening older people because they’re afraid they’ll be sued if they miss a cancer, Schonberg said. And she notes that some health systems award bonuses to clinicians whose patients have high screening rates.
In addition, “doing less can be perceived as a lack of caring or as ageism,” Schonberg said. “It can be uncomfortable for a physician to explain why doing less is more.”
Doctors should prioritize what they can do to help patients be healthier, said Dr. Louise Walter, chief of geriatrics at the University of California-San Francisco and a geriatrician at the San Francisco VA Medical Center. For many older patients, screening for cancer is not their most pressing need.
“Instead of spending time and effort on things that are hurtful and never going to help them, why not direct time and energy on things that will help them live longer and better?” Walter asked.
For example, Walter might tell a patient, “‘Right now, you have really bad heart failure and we need to get that under control,’” Walter said.
Other key issues for many older people include preventing falls, treating depression and alleviating stress in their caregivers, Walter said. Gross said he urges patients to take steps shown to improve their health, such as getting a flu shot or exercising at least 15 minutes a day.
“These are things that can help them feel better very quickly,” Walter said. “Screenings can take years to have a benefit, if at all.”
Facing bipartisan hostility over high drug prices in an election year, the pharma industry's biggest trade group boosted revenue by nearly a fourth last year and spread the millions collected among hundreds of lobbyists, politicians and patient groups, new filings show.
It was the biggest surge for the Pharmaceutical Research and Manufacturers of America, known as PhRMA, since the group took battle stations to advance its interests in 2009 during the run-up to the Affordable Care Act.
"Does that surprise you?" said Billy Tauzin, the former PhRMA CEO who ran the organization a decade ago as Obamacare loomed. Whenever Washington seems interested in limiting drug prices, he said, "PhRMA has always responded by increasing its resources."
The group, already one of the most powerful trade organizations in any industry, collected $271 million in member dues and other income in 2016. That was up from $220 million the year before, according to its latest disclosure with the Internal Revenue Service.
PhRMA spent $7 million last year to prepare its ubiquitous "Go Boldly" ad campaign and gave millions to politicians who were up for election in both parties in dozens of states. It lavished more than $2 million on scores of groups representing patients with various diseases — many of them dealing with high drug costs.
Some of the biggest patient-group checks went to the American Autoimmune Related Disease Association, for $260,000; the American Lung Association, for $110,000; the Juvenile Diabetes Research Foundation, for $136,150; and the Lupus Foundation of America, for $253,500.
PhRMA also gave big money to national political groups financing congressional, presidential and state candidates. The conservative-leaning American Action Network got $6.1 million. The Republican Governors Association got $301,375. Its Democratic counterpart got $350,000.
PhRMA's state and federal lobbying spending rose by more than two-thirds from the previous year, to $57 million.
"That's PhRMA. They do it all" to protect drug companies from potential policy risks, said Sheila Krumholz, executive director of the Center for Responsive Politics, which tracks political financing. "And they're going to marshal even more resources when they perceive that these threats or opportunities are most imminent."
Threats seemed especially dire last year. Storms of bad publicity hit the industry in the form of stories about arrogant executives and thousand-dollar pills.
Democratic presidential candidate Hillary Clinton said some pharma companies were "making a fortune off of people's misfortune." Then-candidate Donald Trump, a Republican, suggested he could save $300 billion annually by requiring drugmakers to bid on business.
Nonprofit organizations such as PhRMA must file detailed disclosures with the IRS. PhRMA, which submitted its 2016 report in early November, shared a copy with Kaiser Health News.
The group also aimed dollars at states where policymakers were considering drug-related measures such as price limits or greater price transparency, the document shows.
It gave $64 million to a California fund established to defeat a proposal requiring state agencies to pay no more for drugs than does the federal Department of Veterans Affairs. Also supported by direct contributions from drug companies, the fund spent $110 million last year to defeat the initiative, California regulatory filings show.
This year, California established a less comprehensive law requiring drug firms to give notice and explanation when they substantially raise prices. PhRMA recently sued to block that measure.
In Louisiana, where policymakers were considering proposals to make drug prices clearer to consumers, PhRMA gave campaign contributions directly to scores of state legislators last year. The group also gave hundreds of thousands of dollars to help defeat a ballot proposal for single-payer health care in Colorado.
Last year's massive mobilization underscores how besieged the industry felt over complaints about soaring medicine prices and high profits.
PhRMA's $271 million in revenue for the year represented its biggest budget since 2009, when it recorded $350 million in dues and other revenue.
The $57 million it spent on lobbying was also the most since 2009, when the lobbying bill was $70 million. So was the $7 million spent on advertising, a cost that should rise this year, since the "Go Boldly" ads aired in 2017. PhRMA employed 237 people last year, up from fewer than 200 in 2011.
The association's 37 members include the biggest and best-known drug companies including Johnson & Johnson, Celgene, Merck, Pfizer, Eli Lilly and Amgen. Holly Campbell, a PhRMA spokeswoman, declined to make an executive available to discuss the report, saying it doesn't comment on contributions.
"PhRMA engages with stakeholders across the health care system to hear their perspectives and priorities," she said in an email. "We work with many organizations with which we have both agreements and disagreements on public policy issues."
Patient groups receiving PhRMA money often deny that it influences their policies or keeps them from criticizing high drug prices.
The Lupus Foundation has policies to ensure there is no conflict of interest, a spokeswoman said. At the Juvenile Diabetes Research Foundation, donors such as PhRMA "have no role" in the group's decision-making process, a spokeswoman said.
"No funder influences our position, agenda or science-based messages" at the American Lung Association, its spokeswoman said.
The American Autoimmune Related Disease Association did not respond to requests for comment.
During negotiations over Obamacare, PhRMA agreed to support overhauling health care relatively early in the process, in mid-2009. Then it threw its muscle into promoting the measure, which promised billions in new revenue for members. President Barack Obama signed it into law in March 2010.
PhRMA shrank substantially after that, taking in around $205 million for several years in a row starting in 2010.
Last year it agreed to increase dues by 50 percent to raise an extra $100 million, Politico reported. In an attempt to distance itself from drug companies earning bad headlines, it also decided to bar members that didn't invest a minimum in pharmaceutical research.
TORONTO — For Dr. Peter Cram, an American internist who spent most of his career practicing in Iowa City, Iowa, moving here about four years ago was almost a no-brainer.
He’s part of a small cohort of American doctors who, for personal or professional reasons, have moved north to practice in Canada’s single-payer system. Now when he sees patients, he doesn’t worry about whether they can afford treatment. He knows “everyone gets a basic level of care,” so he focuses less on their finances and more on actual medical needs.
Cram treats his move as a sort of life-size experiment. As a U.S.-trained physician and a health system researcher, he is now studying what he says is still a little-understood question: How do the United States and Canada — neighbors with vastly different health systems — compare in terms of actual results? Does one do a better job of keeping people healthy?
For all of the political talk, in many ways it is still an open question.
“The Canadian system is not perfect. Neither is the United States’,” Cram said over coffee in Toronto’s Kensington Market. “Anyone who gives you a sound bite and says this system should be adopted by this country … I think they’re being almost disingenuous.”
Still, American support for government-run, single-payer health care, once a fringe opinion, is picking up momentum.
Sen. Bernie Sanders, the Vermont independent who emphasized single-payer health care in his 2016 presidential bid, helped move Canada into the U.S. spotlight.
Lawmakers in California and New York have taken steps toward such programs on a statewide level, and the concept is a hot topic in gubernatorial campaigns in both Illinois and Maryland.
In addition, polling finds doctors and patients increasingly supportive, though the percentages in favor typically drop when questions are focused on the taxpayer costs of such a system.
Although Canada spends less per person on health care than the United States does, many Canadian experts worry that growing health costs pose a serious challenge. (Shefali Luthra/KHN)
In Canada, medical insurance comes through a publicly funded plan. And, while covering everyone, Canada still spends far less on health care than the United States does: just over 10 percent of its GDP, compared with the United States’ 16 percent.
To many American advocates, Canada’s health system sounds like the answer to the United States’ challenges.
But in Toronto, experts and doctors say the United States first must address a more fundamental difference. In Canada, health care is a right. Do American lawmakers agree?
“The U.S. needs to get on with the rest of the world and get an answer on that issue before it answers others,” said Dr.Robert Reid, a health quality researcher at the University of Toronto, who has practiced medicine in Seattle.
It’s an obvious disconnect, said Dr. Emily Queenan, a family doctor now practicing in rural Ontario. Queenan, 41, grew up in the United States and did her residency in Rochester, N.Y. By 2014, after about five years of frustrating battles with insurance companies over her patients’ coverage, she had enough. She found herself asking, why not Canada?
She moved north. Gone, she said, are the reams of insurance paperwork she faced in America. Her patients don’t worry about affording treatment.
“We have here a shared value that we all deserve access to health care,” said Queenan. “That’s something I never saw in the States.”
Sanders has pushed the discussion, with a “Medicare-for-All” bill in Congress and in a visit to Toronto this fall. It was part fact-finding mission and part publicity tour. On that trip, doctors, hospital leaders and patients painted a rosy picture where everyone gets top-notch care, with no worries about its cost to them.
Sanders and Ontario Premier Kathleen Wynne meet with doctors and patients at Toronto General Hospital. (Shefali Luthra/KHN)
“They have managed to provide health care to every man, woman and child without any out-of-pocket cost,” Sanders told reporters while speaking on the ground floor of Toronto General Hospital. “People come to a facility like this, which is one of the outstanding hospitals in Canada. They undergo a complicated heart surgery, and they leave without paying a nickel.”
It sounds idyllic. But the reality is more complicated.
While progressives tout the Canadian system for efficiently providing universal health care, the Commonwealth Fund, a nonprofit research group, puts it just two spots above the United States — which ranks last — in its health system assessment. It suggests that in timeliness, health outcomes and equitable access to care, Canada still has much to improve.
“If you deny there are trade-offs, I think you’re living in wonderland,” Cram said.
The Canadian Vibe
In Canada, everyone gets the same government-provided coverage. Provinces use federal guidelines to decide what’s covered, and there’s no cost sharing by patients.
“Come to our waiting room,” said Dr. Tara Kiran, a family doctor at St. Michael’s Hospital, in Toronto. “You will see people who are doctors or lawyers alongside people who are homeless or new immigrants. People with mental health issues or addiction issues together with people who don’t.”
But that insurance — which accounts for 70 percent of health spending in Canada —addresses only hospitals and doctors. Prescription medications, dentists, eye doctors and even some specialists aren’t covered. Most Canadians get additional private insurance to cover those.
The Canadian health care system guarantees that doctors and hospital visits are covered. But it doesn’t include a prescription drug benefit, an omission advocates are pushing to change. (Shefali Luthra/KHN)
In countries such as Britain or Germany people can opt out to buy private insurance. Canada prohibits private insurers from offering plans that compete with the government, a restriction some doctors are suing to lift. It’s not a popular view in Canada, experts said, but the implications are significant.
Here, the debate focuses more on bringing down health spending — a concern in the United States, too, but one often overtaken by politics.
Canada’s provinces put, on average, 38 percent of their budgets into health care, according to a 2016 report from the Canadian Institute for Health Information, a nonprofit organization. Canada’s single-payer system is supported by a combination of federal and provincial dollars, mostly raised through personal and corporate income taxes. (A few provinces charge premiums, which are income-based and collected with taxes.)
“We make improvements or change things only to have additional debates about other things. Those debates are constant, and they should be,” Reid said. “[But] most of what you hear in the U.S. is back to the tenor of the insurance framework, whether [they] should have Obamacare or not.”
Taxes in Canada are generally higher than in the United States. Canada, for instance, collects a levy on goods and services and also taxes wealthier citizens at a higher income tax rate.
But many here call that a concession worth making, and also note that they don’t have to pay separate premiums for health care as people in the United States do.
“We can’t have what we have if we don’t pay the taxes,” said Brigida Fortuna, a 50-year-old Toronto resident and professional dog groomer, while on her way to a medical appointment. “But you have to take care of your people. … If you don’t have good health care, you’re not going to have a good society.”
The Trade-Offs
That said, it’s not a perfect system. Canadian health care doesn’t cover prescriptions, physical therapy and psychotherapy. And there’s the concern that Canadians wait longer for health care than would Americans with robust health coverage.
There are cases, Reid said, when cancer care in Canada is delayed enough to yield health problems. Ex-pat Cram pointed to research that suggests low-income people are likely to wait longer for medical care — which can result in worse health outcomes.
“We do have a two-tiered system,” he said. “Most know it. Few will admit it.”
Typically, experts said, people with serious medical needs will jump to the front of the line for medical care. Kathleen Wynne, Ontario’s Liberal Party premier, said the Canadian government is actively trying to improve wait times.
But so far, it’s unclear how effective that’s been. A 2017 report from the nonprofit Canadian Institute for Health Information found that wait times had dropped for hip fracture repairs. But waits for, say, MRIs and cataract surgery have actually gotten worse. Depending on their province, the average wait for cataract removal ranged from 37 days to 148 days.
Many patients, though, said the waits were a trade-off they were willing to make. Toronto-based Nate Kreisworth, a 37-year-old music composer and producer, called it an obvious choice.
“You are not going to die because you’re waiting,” he said on a recent sunny morning while walking with his dog near Kensington Market. “Better wait times for everything? Sure, why not. But as long as the major issues are being covered, then I don’t think it’s really much of an issue.”
As Fortuna put it: “If you go for a headache and someone else is going to lose their arm, of course they’re going to take care of that person. I’m OK with that, because someday that could be me, too.”
Waits aren’t the only concern, though. There’s financing — and what it would cost for the United States to implement a system like Canada’s.
Because Americans have higher expectations about what a health plan should cover, it would be more expensive to adapt a Canadian approach, said Dr. Irfan Dhalla, an internist and health quality researcher in Toronto. And the quality may differ from what they are used to.
And in Canada, “everyone gets Kmart care,” Cram said. “There’s no Neiman Marcus care.”
Of course, some amenities that drive up costs — fancier food, softer gowns or private rooms — don’t necessarily produce better results.
A 2017 study found that patients with cystic fibrosis fared better in Canada than in the United States. But on the other hand, 2015 research comparing surgical outcomes found better results in the United States than in Canada. The Commonwealth Fund’s most recent ranking places Canadian health outcomes above America’s, but only by two slots.
Even so, many Canadians said they couldn’t imagine living with an American system. It’s a question not just of efficiency, but of fairness. Kreisworth compared his experience to that of family members in the United States.
“I talk to my brother’s girlfriend who is a part-time worker who has no [health] benefits — who would just be sick and not go to the doctor because she couldn’t afford to pay,” he said. “I can’t imagine that here. It seems like — it’s so wrong. It just seems utterly wrong.”
At least six clinical labs are mired in bankruptcy court after Medicare alleged they improperly billed the government for unnecessary urine, genetic, or heart disease tests.
Five years ago, Companion DX Reference Lab hoped to cash in on cutting-edge genetic tests paid for by Medicare.
The Houston lab marketed a test to assess how a person’s genes affect tolerance for drugs such as opiates used to treat chronic pain. It also ran DNA tests to help treat cancer and urine screens to monitor drug abuse.
But the lab went bust last year after Medicare ordered it to repay more than $16 million for genetic tests health officials said were not needed.
Companion Dx is one of at least six clinical labs mired in bankruptcy court after Medicare alleged they improperly billed the government for unnecessary urine, genetic or heart disease tests expected to cause hundreds of millions dollars in losses to taxpayers, an investigation by Kaiser Health News found.
As the nation’s bill for drug and genetic tests has climbed to an estimated $8.5 billion a year, there’s mounting suspicion among health insurers that some testing may do more to boost profit margins than help treat patients.
Medicare has slashed fees for urine tests and tightened coverage of some genetic screens, which can cost Medicare $1,000 or more per person. Private insurers, who mostly have paid these bills without question, also are taking a more penetrating look at spending on the controversial lab work.
Yet, getting these firms to repay Medicare and private insurers remains a formidable challenge. While some doctor-owned labs have dodged collection efforts for years, several testing firms deeply in debt to Medicare appear to have few assets to repay overcharges dating back years, court records show.
“Medicare shouldn’t be paying for dubious tests, but the time to catch that is in the very beginning when [labs] are asking for payment,” said Steve Ellis, vice-president of Taxpayers for Common Sense, a budget watchdog group. “They need to increase oversight so the dollars don’t go out the door in the first place.”
A spokesman for the federal Centers for Medicare & Medicaid Services (CMS) had no comment. Neither did the Department of Justice, which represents the government’s interests in court.
Labs can run a range of genetic and drug tests using a saliva sample, blood or urine specimen. The price tag to Medicare can mount quickly, especially when doctors order highly specialized tests for large numbers of patients. Two bankrupt labs that federal officials say routinely overused tests to detect rare heart ailments in the elderly, for instance, could end up owing the government a total of more than $200 million, court records show.
Some labs have kept operating in bankruptcy while others liquidated equipment and sold off assets. Several bankruptcy trustees, whose duty is to ferret out assets, are suing suppliers, insurers and some doctors to recover funds.
Whether they can raise the pile of cash needed to repay Medicare is doubtful.
Companion Dx, according to bankruptcy records, had $117,497 cash on hand at the end of September. Medicare is seeking the return of $16.2 million paid to the company for services “not considered medically necessary,” according to a January court filing.
The Texas lab had no comment, but in court filings has blamed its collapse on disagreements with Medicare over the merits of its tests and government audits that retroactively disallowed claims. Medicare pays only for services it deems “medically necessary,” and audits typically take many years to complete.
Companion Dx opened in January 2012 expecting to “capture favorable profit margins that existed in connection with this cutting edge technology,” the company wrote in its bankruptcy filing.
However, starting in 2013, Medicare began having second thoughts about the validity of some tests and ultimately decided to cover them on just 1 percent of patients, according to the company. The lab declared bankruptcy in July 2016. The case is pending.
Iverson Genetic Diagnostics Inc. is another lab that turned to bankruptcy court as Medicare tried to reclaim $19.7 million, court records show. The case is pending.
Medicare took aim at the Seattle firm in November 2013 after reviewing “numerous” complaints of billings for genetic tests that patients “had not actually received,” federal officials wrote in a court filing.
A later federal audit concluded that Iverson had charged Medicare for tests that were “not reasonable and necessary.” In September 2015, about two months after Medicare called for the refund, the lab filed for bankruptcy.
Iverson denied overbilling Medicare and is appealing the Medicare decision, which it said in a court filing “was not based upon sufficient or proper evidence.” And Iverson denied wrongdoing in court filings.
Neither the lab, now located in Charleston, S.C., nor its lawyers would comment.
In another case, Pharmacogenetics Diagnostic Laboratory LLC in Louisville exited bankruptcy in late October without repaying Medicare $26.3 million for disallowed genetic tests. The lab, set up in 2004 by two University of Louisville professors, strongly disputed Medicare’s findings but said they were the “primary reason” for the bankruptcy, court records show.
Charity Neukomm, a lawyer for the lab, said another medical group agreed to purchase all its assets “free and clear of liens.” That left nothing for the government.
There’s also little chance that Natural Molecular Testing Corp., a defunct genetic testing lab, will repay the $71 million it owes Medicare, according to John Kaplan, an attorney for the bankruptcy trustee.
Kaplan said the lab near Seattle, which opened in 2010, was “printing money from billing Medicare” until the government suspended payments in April 2013. The company filed for bankruptcy in 2013 in the face of a Medicare audit of its billing and concern over its business practices, such as paying some doctors who ordered its tests as much as $10,000 a month in consulting fees, according to court records.
Five years in, the bankruptcy case is expected to settle next year, but there’s likely to be “no cash left” to repay Medicare, Kaplan said.
Critics argue that Medicare has been slow to assess the benefits of new and controversial tests and technologies — even when soaring costs signaled a warning of possible overuse.
Spending on genetic testing, for example, shot up from about $167 million in 2013 to more than $466 million a year later, according to Medicare billing data. In 2015, the program spent about $317 million on the tests and some $165 million last year. Government auditors credit tighter oversight for the sharp decline in billing.
Ellis, the budget watchdog, said the “huge jump” in these bills should have “sent out a red flag.”
Medicare officials don’t routinely verify that the sales claims labs make to doctors are rooted in scientific evidence. Some labs have hawked genetic tests as a tool for making pain management safer. The labs contend the tests can pinpoint the proper drugs and dosage for each patient based on their genetic makeup, thus reducing the threat of overdose or other injury.
However, many experts argue that the science hasn’t caught up to the sales pitch — and that some high-priced tests may do little to diagnose or treat illness.
Genetic tests “are not ready for prime time,” said Charles Argoff, professor of neurology at Albany Medical College in New York. He said their impact on medical care “hasn’t been measured.”
Court records show that the legal battles to recover assets from failed labs often plod on for years, especially when trustees believe labs paid illegal fees or other kickbacks to persuade doctors to order dubious tests.
“Some of these cases never go away,” said David Schumacher, a Boston health care lawyer who has defended doctors against these claims. Still, he said that even after years of legal wrangling Medicare often is unlikely to “be made whole and fully repaid.”
The trustee for Heart Diagnostic Laboratory, which marketed a panel of blood tests to detect heart disease and other illnesses before its June 2015 bankruptcy, has filed more than three dozen lawsuits to recover money paid to doctors and medical offices, including suspect consulting fees.
“Our analysis is that all of these payments were tainted and therefore we’re entitled to go after them,” said Richard Kanowitz. He added: “It’s an uphill battle.”