The short answer: Competition doesn't do its traditional job of tamping down costs.

This article first appeared March 08, 2018 on Kaiser Health News.

By Jenny Gold

YUBA CITY, Calif. — When Landon Morris was diagnosed with hemophilia shortly after birth, his mother, Jessica Morris, was devastated. “It was like having your dreams — all the dreams you imagined for your child — just kind of disappear,” she recalled.

Hemophilia, a rare bleeding disorder caused by a gene mutation that prevents blood from clotting properly, is typically passed from mother to son. Morris’ grandfather had it, and she remembered hearing how painful it was. “It was almost like he was bubble-wrapped,” she said. “He was coddled, because his mom didn’t want him to get hurt.”

But Landon’s life turned out much different than she expected.

“He’s wild. He’s probably sometimes the roughest of them all,” she said, as she watched the 6-year-old race around a park. “He leads a totally normal life. He plays T-ball. He’ll start soccer in the fall. He runs and jumps and wrestles with his brothers.”

That’s due almost entirely to his medication — the kind that wasn’t available in his grandfather’s day. For the Morris family, this type of drug — broadly known as clotting factor — is a miracle, helping Landon’s blood clot normally. And its cost is almost entirely covered by his father’s federal employee health plan.

But for the health care system, such drugs are enormously expensive, among the priciest in the nation. Medications to treat hemophilia cost an average of more than $270,000 annually per patient, according to a 2015 Express Scripts report. If complications arise, that annual price tag can soar above $1 million. The U.S. hemophilia drug market, which serves about 20,000 patients, is worth $4.6 billion a year, according to the investment research firm AllianceBernstein.

Examining the stubbornly high cost of these medications opens a window into why some prescription drugs the United States — especially those for rare diseases — have stratospheric prices. The short answer: Competition doesn’t do its traditional job of tamping down costs.

Vying For Patients

The market for hemophilia medicines in the United States is flooded with 28 different drugs, with another 21 drugs in development. Because blood factor drugs are biological products — in this case, a protein — there are no cheaper copies, called biosimilars, available. Not only do prices rise steadily as each new product comes on the market, demand is growing — and pushing costs upward — as more and more clotting factor is used to prevent bleeding episodes, not just to treat them.

Yet competition has not brought prices down in the way someone “operating at the level of undergrad Econ 101 would expect,” said Jerry Avorn, a professor at Harvard Medical School who studies prescription drug costs.

The problem is that companies have no incentive to lower prices. Patients generally don’t push back because insurers pay the bulk of the cost. And insurers tend not to object because the market for the drugs — expensive as they are — is small and the patients are especially vulnerable.

For drug companies, Avorn said, “it’s a magical formula: Lifesaving drug, child at risk of bleeding to death — it kind of casts anybody who looks at costs into the role of some evil Scrooge-like person.”

“The insurers don’t want to end up on the front page of the newspaper saying Little Timmy bled to death because his drug wasn’t covered,” he said.

Also, because prices are high across the hemophilia market, no drug company wants to be the one to blink first. “They don’t want to get a price war started and end up at a super low price point,” said Edmund Pezalla, a consultant to pharmaceutical companies and former executive at Aetna.

So, these drugmakers compete not on price but clinical benefits — such as how long the drugs’ effects last — and through intensive marketing. The pool of potential customers is so valuable that companies often vie directly for individual patients.

Manufacturers, as well as specialty pharmacies that sell the drugs, hire patients and parents as recruiters and advisers, hold dinners and holiday parties, offer scholarships to patients and even run summer camps for children with the disease. The Morris family regularly receives such invitations.

Dr. Jonathan Ducore, a pediatric hematologist-oncologist at the University of California-Davis Hemophilia Treatment Center in Sacramento, said some of his patients are persuaded by drug company presentations to switch medications. ”But the real differences between the drugs are limited,” he said.

Ducore said he tells patients if he thinks they are being misled by drugmakers about what a product will do. “But even though the tactics may seem a little smarmy, if it's the patient’s choice, you have to go with it,” said Ducore, who has been Landon’s doctor since the boy was born.

The first clotting factor products, which came onto the market in the mid-1960s, were derived from human blood plasma, with thousands of donations combined to create one batch. This proved disastrous in the 1980s, when donors unwittingly spread HIV into the blood supply. An estimated 4,000 people with hemophilia — about 40 percent of the patient population in the U.S. — died from AIDS as a result.

In the 1990s, manufacturers introduced a product that did not carry the disease risk of plasma-based drugs — made by cloning human clotting proteins in animal cells. Companies charged a premium for this ever-more-popular “recombinant factor.”

Recombinant factor is difficult and delicate to make, said Steve Garger, a development scientist at Bayer, which produces two popular factor products at its Berkeley, Calif., plant — including Landon Morris’ drug, Kogenate.

Inside a concrete building on the campus, kidney cells from baby hamsters are grown in stainless-steel vessels called bioreactors, and the clotting factor they produce is then purified in steel tanks kept in cold rooms. Working at full capacity, this factory produces less than a pound of clotting factor each year — but when diluted with other ingredients, it’s enough to treat thousands of patients in 80 countries.

The investment in manufacturing and marketing is only part of the reason for the high cost of the drugs, said Kevin O’Leary, vice president of pricing and contracting at Bayer. Bayer does not simply add up the costs, slap on a profit margin and come up with the price, O’Leary explained.

Instead, he said, the company begins by talking to insurers, doctors and patients to get a sense of what value its products bring to the market, especially compared to drugs already available. Bayer then sets a price based on both its investment and the product’s perceived worth. In the end, he said, “we're charging a price that's competitive with the other factor products on the market.”

Bayer’s annual sales from its hemophilia drugs were 1.166 billion euros in 2016. That’s the equivalent of about $1.45 billion in the U.S.

Pushing Back On Costs

In Europe, hemophilia drugs cost less than half what they cost in the U.S. That’s because payers — usually governments — request bids and pick products based on cost and quality.

Without pushback from insurers in the U.S., “the price of any drug in the U.S. is whatever the market will bear as seen by the manufacturer,” said Avorn of Harvard.

Recently, a few insurance companies have quietly started to push back on costs. Bayer’s O’Leary said several insurers have approached the company and demanded rebates in exchange for offering the drug to their customers. O’Leary would not discuss the details because he said the contracts are confidential.

State Medicaid programs, which provide health insurance to low-income Americans and cover about half of hemophilia patients, already receive significant rebates from hemophilia drug manufacturers.

Michelle Rice, a senior vice president at the National Hemophilia Foundation, said she has been working with several insurers to help them manage costs safely. “We understand the need to control costs, but they can’t impede access to the product a patient needs,” she said.

It is not yet clear whether such efforts will work, let alone spread.

Sitting at a picnic bench at a park, Jessica Morris pages through Landon’s insurance documents. Over the past year, his care cost over $120,000. She wonders sometimes what would happen if they lost their coverage.

“How much would you be willing to pay to have your child lead a normal life?” she said. “I don't think that there's anything we wouldn't pay or sacrifice for him.”

It’s a problem she prays they’ll never have to face.

Brigham Health in Boston is one of a slowly growing number of health systems that encourage selected acutely ill emergency department patients who are stable and don't need intensive, round-the-clock care to opt for hospital-level care at home.

This article first appeared March 06, 2018 on Kaiser Health News.

By Michelle Andrews

Phyllis Petruzzelli spent the week before Christmas struggling to breathe. When she went to the emergency department on Dec. 26, the doctor at Brigham and Women’s Faulkner Hospital near her home in Boston’s Jamaica Plain neighborhood said she had pneumonia and needed hospitalization. Then the doctor proposed something that made Petruzzelli nervous. Instead of being admitted to the hospital, she could go back home and let the hospital come to her.

As a “hospital-at-home” patient, Petruzzelli, 71 this week, learned doctors and nurses would come to her home twice a day and perform any needed tests or bloodwork.

A wireless patch a little bigger than her index finger would be affixed to her skin to track her vital signs and send a steady stream of data to the hospital. If she had any questions, she could talk face-to-face via video chat anytime with a nurse or doctor at the hospital.

Hospitals are germy and noisy places, putting acutely ill, frail patients at risk for infection, sleeplessness and delirium, among other problems. “Your resistance is low,” the doctor told her. “If you come to the hospital, you don’t know what might happen. You’re a perfect candidate for this.”

So Petruzzelli agreed. That afternoon, she arrived home in a hospital vehicle. A doctor and nurse were waiting at the front door. She settled on the couch in the living room, with her husband, Augie, and dog, Max, nearby. The doctor and nurse checked her IV, attached the monitoring patch to her chest and left.

When Dr. David Levine arrived the next morning, he asked why she’d been walking around during the night. Far from feeling uncomfortable that her nocturnal trips to the bathroom were being monitored, “I felt very safe and secure,” Petruzzelli said. “What if I fell while my husband was out getting me food? They’d know.”

After three uneventful days, she was “discharged” from her home hospital stay, and the equipment removed from her home. “I’d do it again in a heartbeat,” Petruzzelli said.

Brigham Health in Boston is one of a slowly growing number of health systems that encourage selected acutely ill emergency department patients who are stable and don’t need intensive, round-the-clock care to opt for hospital-level care at home.

In the couple of years since Brigham and Women’s Hospital started testing this type of care, hospital staff who were initially skeptical have generally embraced it, said Levine.

“They very quickly realize that this is really what patients want, and it’s really good care,” he said.

This approach is quite common in Australia, England and Canada but it’s faced an uphill battle in the United States.

A key obstacle, clinicians and policy analysts agree, is getting health insurers, whose systems aren’t generally set up to cover hospital care provided in the home, to pay for it.

At Brigham Health, the hospital can charge an insurer for a physician house call, but the remainder of the hospital-at-home services are covered by grants and funding from Partners HealthCare’s Center for Population Health, which is affiliated with Brigham Health, said Levine.

Health insurers don’t have a position on hospital-at-home programs, said Cathryn Donaldson, a spokeswoman for America’s Health Insurance Plans, an industry trade group.

“Overall, health insurance providers are committed to ensuring patients have access to care they need, and there are Medicare Advantage plans that do cover this type of at-home care,” Donaldson said in a statement.

Levine, a clinician-investigator at Brigham and Women’s Hospital and an instructor at Harvard Medical School, was the lead author of a study published last month that reported the results of a small, randomized, controlled trial comparing the health care use, experience and costs of Brigham patients who either received hospital-level care at home or in the hospital in 2016.

The 20 patients analyzed in the trial had one of several conditions, including infection, heart failure, chronic obstructive pulmonary disease or asthma. The trial found that while there were no adverse events in the home-care patients, their treatment costs were significantly lower, about half that of patients treated in the hospital.

Why? For starters, labor costs for at-home patients are lower than for patients in a hospital, where staff must be on hand 24/7. Home-care patients also had fewer lab tests and visits from specialists.

The study found that both groups of patients were about equally satisfied with their care, but the home-care group was more physically active.

Brigham Health is conducting further randomized controlled trials to test the at-home model for a broader range of diagnoses.

Dr. Bruce Leff began exploring the hospital-at-home concept more than 20 years ago, conducting early studies at Veterans Affairs medical centers and Medicare Advantage plans that found fewer patient complications, better outcomes and lower costs in home-care patients.

Caregivers reported less stress, Leff’s research found. For caregivers, traveling to an unfamiliar hospital, finding and paying for parking and trying to time bedside meetings with clinical staff, all the while worried about a loved one’s health, is wearing, experts note.

Hospitals, accustomed to the traditional “heads-and-beds” model that emphasizes filling hospital beds in a brick-and-mortar facility have been slow to embrace change, however.

There are practical hurdles, too.

“It’s still easier to get Chinese food delivered in New York City than to get oxygen delivered at home,” said Leff, a professor of medicine and director of Johns Hopkins Medical School’s Center for Transformative Geriatric Research.

Since Mount Sinai’s seven-hospital system launched its Hospital-at-Home program in New York City in 2014, more than 700 patients have chosen home over hospital care. Patients can be referred to the program from selected emergency departments as well as some Mount Sinai primary care practices and urgent care centers. And they have fared well on a number of measures.

The average length of stay for acute care was 5.3 days in the hospital versus 3.1 days of treatment for home-care patients, while 30-day readmission rates for home-based patients were about half of those in the hospital: 7.8 percent versus 16.3 percent for the two-year period ending December 2016.

Begun with a three-year, $9.6 million grant from the federal Center for Medicare & Medicaid Innovation in 2014, Mount Sinai’s program initially focused on Medicare patients with six conditions, including congestive heart failure, pneumonia and diabetes. Since then, the program has expanded to include dozens of conditions, including asthma, high blood pressure and serious infections like cellulitis, and is now available to some privately insured and Medicaid patients.

The health system has also partnered with Contessa Health, a company with expertise in home care, to negotiate contracts with insurers to pay for hospital-at-home services.

Among other things, insurers are worried about the slippery slope of what it means to be hospitalized, said Dr. Linda DeCherrie, clinical director of the mobile acute care team at Mount Sinai Health System.

“[Insurers] don’t want to be paying for an admission if this patient really wouldn’t have been hospitalized in the first place,” DeCherrie said.

Oklahoma's agency in charge of funding opioid treatment has seen more than $27 million dollars chipped away from its budget in just three years.

This article first appeared March 05, 2018 on Kaiser Health News.

By John Daley, Colorado Public Radio and Jackie Fortier, Stateimpact Oklahoma

Opioids were on the White House agenda Thursday — President Trump convened a summit with members of his administration about the crisis. And Congress authorized funds for the opioid crisis in its recent budget deal — but those dollars aren't flowing yet, and states say they are struggling to meet the need for treatment.

The Oklahoma agency in charge of substance abuse has been told by the state's legislature to cut more than $2 million from this fiscal year's budget.

"Treatment dollars are scarce," said Randy Tate, president of the Oklahoma Behavioral Health Association, which represents addiction treatment providers.

It's like dominoes, Tate said. When you cut funding for treatment, other safety net programs feel the strain.

"Any cuts to our overall contract," he said, "really diminish our ability to provide the case management necessary to advocate for homes, food, shelter, clothing, primary health care and all the other things that someone needs to really be successful at tackling their addiction."

In just three years, Oklahoma's agency in charge of funding opioid treatment has seen more than $27 million dollars chipped away from its budget — thanks to legislative gridlock, slashed state taxes and a drop in oil prices (with the additional loss in state tax revenue that resulted).

Jeff Dismukes, a spokesman for Oklahoma's Department of Mental Health and Substance Abuse Services, says the already lean agency has few cost-cutting options left.

"We always cut first to administration," he said, "but there's a point where you just can't cut anymore."

The agency may end up putting off payments to treatment providers until July — the next fiscal year. Tate says that could be devastating.

"Very thinly financed, small rural providers are probably at risk of going out of business entirely — up to and including rural hospitals," he said.

Getting treatment providers to open up shop in rural areas is really hard, even in good times, and more financial uncertainty could make that problem worse. In the meantime, according to an Oklahoma state commission's opioid report, just 10 percent of Oklahomans who need addiction treatment are getting it.

That statistic is similar in Colorado. And as 2018 began, Colorado's escalating opioid crisis got worse, when the state's largest drug and alcohol treatment provider, Arapahoe House, shut its doors.

The facility provided recovery treatment to 5,000 people a year. Denise Vincioni, who directs another treatment center, the Denver Recovery Group, says other facilities have scrambled to pick up the patients.

Most of Arapahoe's clients were on Medicaid. Autumn Haggard-Wolfe, a two-time Arapahoe House client who is now in recovery, worries the facility's closing will have dire consequences, especially for people who need inpatient care, as she did.

"I feel like the only other option right now in therapy would be jail for people," she said, "and people die in there from withdrawing."

Arapahoe House's CEO blamed its closure on the high cost of care and poor government reimbursement for services.

The mother of Colorado state lawmaker Brittany Pettersen struggled with addiction, and was treated at Arapahoe House. Pettersen says treatment centers rely on a crazy quilt of funding sources and are chronically underfunded — often leaving people with no treatment options.

"We have a huge gap in Colorado," Pettersen said, "and that was before Arapahoe House closed."

She is pushing legislation in the state to increase funding for treatment. But to get tens of millions of dollars in federal matching funds, Colorado lawmakers need to approve at least $34 million a year in new state spending.

That price tag may simply be too high for some lawmakers. But either way, she added, "It's going to take a lot to climb out of where we are."

Colorado did get new federal funds to fight the opioid crisis through the 21st Century Cures Act, passed in December of 2016, but it was just $7.8 million a year for two years — divvied up among a long list of programs.

An investigation by Kaiser Health News and the USA TODAY Network has discovered that more than 260 patients have died since 2013 after in-and-out procedures at surgery centers across the country.

This article first appeared March 2, 2018, on Kaiser Health News.

By Christina Jewett, Kaiser Health News and Mark Alesia, USA TODAY Network

The surgery went fine. Her doctors left for the day. Four hours later, Paulina Tam started gasping for air.

Internal bleeding was cutting off her windpipe, a well-known complication of the spine surgery she had undergone.

But a Medicare inspection report describing the event says that nobody who remained on duty that evening at the Northern California surgery center knew what to do.

In desperation, a nurse did something that would not happen in a hospital.

She dialed 911.

By the time an ambulance delivered Tam to the emergency room, the 58-year-old mother of three was lifeless, according to the report.

If Tam had been operated on at a hospital, a few simple steps could have saved her life.

But like hundreds of thousands of other patients each year, Tam went to one of the nation’s 5,600-plus surgery centers.

Such centers started nearly 50 years ago as low-cost alternatives for minor surgeries. They now outnumber hospitals as federal regulators have signed off on an ever-widening array of outpatient procedures in an effort to cut federal health care costs.

Thousands of times each year, these centers call 911 as patients experience complications ranging from minor to fatal. Yet no one knows how many people die as a result, because no national authority tracks the tragic outcomes. An investigation by Kaiser Health News and the USA TODAY Network has discovered that more than 260 patients have died since 2013 after in-and-out procedures at surgery centers across the country. Dozens — some as young as 2 — have perished after routine operations, such as colonoscopies and tonsillectomies.

Reporters examined autopsy records, legal filings and more than 12,000 state and Medicare inspection records, and interviewed dozens of doctors, health policy experts and patients throughout the industry, in the most extensive examination of these records to date.

The investigation revealed:

• Surgery centers have steadily expanded their business by taking on increasingly risky surgeries. At least 14 patients have died after complex spinal surgeries like those that federal regulators at Medicare recently approved for surgery centers. Even as the risks of doing such surgeries off a hospital campus can be great, so is the reward. Doctors who own a share of the center can earn their own fee and a cut of the facility’s fee, a meaningful sum for operations that can cost $100,000 or more.
   
• To protect patients, Medicare requires surgery centers to line up a local hospital to take their patients when emergencies arise. In rural areas, centers can be 15 or more miles away. Even when the hospital is close, 20 to 30 minutes can pass between a 911 call and arrival at an ER.
   
• Some surgery centers are accused of overlooking high-risk health problems and treat patients who experts say should be operated on only in hospitals, if at all. At least 25 people with underlying medical conditions have left surgery centers and died within minutes or days. They include an Ohio woman with out-of-control blood pressure, a 49-year-old West Virginia man awaiting a heart transplant and several children with sleep apnea.
   
• Some surgery centers risk patient lives by skimping on training or lifesaving equipment. Others have sent patients home before they were fully recovered. On their drives home, shocked family members in Arkansas, Oklahoma and Georgia discovered their loved ones were not asleep but on the verge of death. Surgery centers have been criticized in cases where staff didn’t have the tools to open a difficult airway or skills to save a patient from bleeding to death.

Most operations done in surgery centers go off without a hitch. And surgery carries risk, no matter where it’s done. Some centers have state-of-the-art equipment and highly trained staff that are better prepared to handle emergencies.

But Kaiser Health News and the USA TODAY Network found more than a dozen cases where the absence of trained staff or emergency equipment appears to have put patients in peril.

And in cases similar to Tam’s, upper-spine surgery patients have been sent home too soon, with the risk of suffocation looming.

In 2008, a 35-year-old Oregon father of three struggled for air, pounding the car roof in frustration while his wife sped him to a hospital. A Dallas man collapsed in his father’s arms waiting for an ambulance in 2011. Another Oregon man began to suffocate in his living room the night of his upper-spine surgery in 2014. A San Diego man gasped “like a fish,” his wife recalled, as they waited for an ambulance on April 28, 2016.

None of them survived.

Spinal surgery patient McArthur Roberson, 60, lost more than a quart of blood during the operation and struggled to breathe after surgery, his family claimed in a lawsuit. He died on the way home.

If he “had been observed in a hospital overnight,” said Dr. Daniel Silcox, an Atlanta spine surgeon and expert for the family in their lawsuit, “his death would not have occurred.”

The surgery center denied wrongdoing in the case, which reached a confidential settlement in 2017.

Many in the health care field — from doctors to private insurance companies to Medicare — have dismissed the mounting deaths as medical anomalies beyond the control of physicians.

USA TODAY Network and KHN reporters contacted 24 doctors and surgery center administrators about patient deaths and none would answer questions about what went wrong, citing patient privacy laws, or referring reporters to attorneys. Responding to lawsuits around the nation, surgery centers have argued that fatal complications were among the known outcomes of such surgeries. Two centers blamed patients for negligence in their own demise.

Bill Prentice, chief executive of the Ambulatory Surgery Center Association, declined to speak about individual cases but said he has seen no data proving surgery centers are less safe than hospitals.

“There is nothing distinct or different about the surgery center model that makes the provision of health care any more dangerous than anywhere else,” Prentice said. “The human body is a mysterious thing, and a patient that has met every possible protocol can walk in that day and still have something unimaginable happen to them that has nothing to do with the care that’s being provided.”

However, Dr. Kenneth Rothfield, board member of the Physician-Patient Alliance for Health & Safety, said many surgery centers and physicians push the envelope on how much can be done in outpatient centers.

“It’s important to realize that surgery centers are not hospitals,” he said. “They have different resources, different equipment.”

At a hospital, doctors and nurses … know how they are going to respond. These guys at the surgery centers are walking on a tightrope with no safety net.

The explosive growth of surgery centers — which receive $4.1 billion a year from Medicare — has taken place under circumstances some medical experts consider unseemly.

Federal law allows surgery center doctors — unlike others — to steer patients to facilities they own, rather than the full-service hospital down the street. In some cases, doing so could increase the risk to a patient, but double a physician’s profits.

Prentice said physician ownership of surgery centers is a good thing.

“The physicians who practice there are responsible for everything that happens in that surgery center from the moment the patient walks out of their car in the parking lot to the moment they leave,” he said.

But several studies have shown that surgery center doctors who are owners perform operations more frequently. And in lawsuits across the country, surgery center doctors have been accused of taking risks with patients.

Even some who’ve made their living in the surgery center industry have expressed concerns. Dr. Larry Teuber, a South Dakota neurosurgeon who worked as an executive in the surgery center industry for 22 years, said he has watched surgery center owners take on increasingly complex — and lucrative — orthopedic and spinal surgeries, undercutting a nearby hospital’s profits for their own gain.

“When you’re making money doing [complex surgeries] you get on a slippery ethical slope,” Teuber said. “The money overshadows everything.”

The History

The first surgery center in the U.S. opened in Phoenix in 1970, a place “squeezed between neighborhood shops and a Baptist church,” where, for $90, a child could receive an incision to relieve pressure on the inner ear, The Arizona Republic reported at the time.

The pioneering doctors, John Ford and Wallace Reed, didn’t see why patients needed to be hospitalized for such minor surgeries.

Taking the procedures out of hospitals reduced the cost for patients and insurers because surgery centers don’t require the same level of staffing or lifesaving equipment.

Medicare helped drive the expansion of surgery centers when it began paying for procedures in 1982.

Then in 1993, Congress encouraged doctors to open surgery centers by exempting them from the second Stark Law, which prevents doctors from steering patients to other businesses they own.

Doctors-turned-entrepreneurs drove early growth, urging their patients to give the centers a chance. Seeing lucrative elective surgeries moving away, hospitals increasingly bought centers of their own. Last year, insurance giant UnitedHealth Group spent $2.3 billion buying a national surgery center chain.

The centers have been popular with patients, who enjoy the convenience and personalized care. Doctors say they like the ease of planning operations without unexpected trauma surgeries upending the schedule. And surgery centers have thrived even as hospitals have battled to contain the spread of infections.

Today, there are 5,616 Medicare-certified centers. The expansion has come despite lingering safety concerns. In 2007, Medicare noted that surgery centers “have neither patient safety standards consistent with those in place for hospitals, nor are they required to have the trained staff and equipment needed to provide the breadth of intensity of care. …” Some procedures are “unsafe” to be handled at surgery centers, the report concluded.

Medicare advised the centers to transfer patients to hospitals when emergencies arise. Only a third of surgery centers participate in a voluntary effort to report how often that happens. They sent at least 7,000 patients to the hospital in the year that ended in September 2017, a KHN analysis of surgery center industry data shows. Not all survive the trip.

In the 21st century in the USA, a doctor doing a surgery on a patient has to call 911? Give me a break. … It’s just absolutely ignorant.

They include James Long, 56, who had no pulse when an ambulance came to the Colorado surgery center where he’d undergone more than five hours of lower-spine surgery in 2014, according to the center’s medical records provided to the family’s attorney.

The state reviewed the case and cited no deficiencies. Jen Kenitzer, the Minimally Invasive Spine Institute administrator, said the center has “extensive procedures in place to respond quickly and appropriately” in emergencies.

Yet Long’s loved ones remain troubled by the case.

“In the 21st century in the USA, a doctor doing a surgery on a patient has to call 911?” said Robin Long, his ex-wife, who did not sue the center. “Give me a break. … It’s just absolutely ignorant.”

Preparation Under Par

Patients enter hospitals with heart attacks, gunshot wounds and traumatic injuries. There, doctors and nurses become skilled at saving lives in emergencies.

Doctors in surgery centers may excel at the procedures they perform most often. But the centers aren’t always prepared and sometimes struggle in a crisis, according to a review of Medicare records and more than 70 lawsuits.

Health inspectors working on behalf of Medicare have discovered 230 lapses in rescue equipment or training regulations at surgery centers since 2015.

A center in California had empty oxygen tanks. One operating on children in Arkansas didn’t have a pediatric tracheotomy set to restore breathing; another lacked pediatric defibrillator pads to shock hearts back into rhythm.

In an ongoing lawsuit against her and the center, anesthesiologist Dr. Yoori Yim testified that she came up empty-handed on Dec. 23, 2015, when grappling to find the right-sized airway tube to save a patient who had stopped breathing.

Rekhaben Shah, 67, had come to Oak Tree Surgery Center in Edison, N.J., for a simple colonoscopy.

Yim tried a variety of methods to help Shah breathe, with limited success. From the moment Shah stopped breathing on the operating table, 33 minutes passed before a paramedic effectively inserted a breathing tube, according to medical and EMS records.

Paramedics responding to the center’s 911 call had to use a video GlideScope to see inside the patient’s throat, equipment the surgery center didn’t have, court testimony says.

By then it was too late. Shah was removed from life support at a nearby hospital on Christmas Day.

Neither Yim nor the center returned calls for comment. In court records, an expert for the surgery center said Shah’s airway was obstructed and it was cleared around the time the paramedics arrived. He said the GlideScope is not required in New Jersey, nor would it likely have made a difference. An expert for Yim, however, said her actions were appropriate and if a GlideScope had been at the center, “we would probably not be discussing this case at all.”

When emergency crews arrive, surgery centers are not always prepared to receive them.

In Yim’s case, paramedics testified that she refused to move away from Shah and allow them to attempt lifesaving measures.

In Florida, paramedics who rushed to a surgery center after its usual operating hours hit a locked door while a patient inside gasped for breath. The 55-year-old remains in a vegetative state.

In 2016, paramedics arrived at West Lakes Surgery Center in Iowa as staff tried to revive 12-year-old Reuben Van Veldhuizen after he experienced complications during a tonsillectomy, according to a Medicare inspection report.

One paramedic told state inspectors she had to ask who was in charge of the resuscitation efforts. No one replied, the inspection report says.

The boy made it to the hospital 37 minutes after the surgery center staff called 911. There, he was pronounced dead.

The family filed suit, alleging that the center and anesthesiologist erred in giving the boy an anesthetic that carries a warning about cardiac arrest risk in young boys.

In court records responding to the lawsuit, the surgery center and anesthesiologist said Reuben’s death was a result of “pre-existing conditions, acts of others, or conditions over which (Defendants) had no control or responsibility.”

Yet lawyers who sue the centers and scrutinize their internal records say they often see deadly delays in care.

Pedro Maldonado, 59, went to Ambulatory Care Center in New Jersey to have his upper digestive tract scoped. He was discovered unresponsive 10 minutes after the seven-minute procedure, according to his widow’s lawsuit.

It took surgery center staff 25 more minutes to start CPR, according to a lawsuit that Philadelphia attorney Glenn Ellis filed on behalf of Maldonado’s widow. Twenty-seven more minutes passed before Maldonado was wheeled into an ER, the widow’s ongoing suit alleges. Maldonado never regained consciousness.

Reached by phone, a center administrator declined to comment. In a legal filing, the center denied claims of wrongdoing.

“At a hospital, doctors and nurses … know how they are going to respond,” Ellis said. “These guys at the surgery centers are walking on a tightrope with no safety net.”

Conveyor Belt Of Care

While the thrum of a hospital continues through the night, some surgery center doctors keep banker’s hours. That means patients whose surgeries end later in the day are sometimes left in the care of one or two nurses for up to 23-hour stays. Some patients have been sent home to grapple with complications on their own.

Sondra Wallace went to the Surgery Center of Oklahoma in early 2017 for a sinus procedure.

After the procedure, doctors saw her blood-oxygen level sinking. They realized she had had a reaction to the anesthesia and at 2 p.m. gave her a drug to reverse the effects, an ongoing lawsuit filed by her husband says.

Then, an hour later, they sent her home with her husband, Larry, the lawsuit says.

It was 3 p.m. on the Friday before Presidents Day weekend.

“I just think they wanted to start their three-day weekend,” said daughter Casey Podoll.

Larry Wallace alleges in the suit that the center gave him no hint that Sondra had a reaction to the anesthesia.

So, Wallace thought nothing of her napping in the back seat as he drove for more than two hours through Oklahoma pastures on his way home. When he arrived, he discovered his wife cold in the back seat. She was pronounced dead at Jackson County Memorial Hospital at 6:30 p.m. that day.

“They didn’t give any indication … that there were any red flags whatsoever,” Podoll said.

Craig Buchan, attorney for the Surgery Center of Oklahoma, said Wallace met discharge criteria and her cause of death has not been determined. He said the center did not close any earlier “than often occurs after the last patient is discharged.”

Cecilia Aldridge said she also felt as if the staff at a surgery center was rushing her out the door, after her 2-year-old daughter’s tonsil surgery in Arkansas in 2015.

A lawsuit filed by the parents said the surgery center “discharged Abbygail too early because a snow storm was moving into the area.”

Abbygail turned blue in the car on the way home. Her mother said she raced into an emergency room, shouting for help, her toddler in her arms.

“She never woke up,” Aldridge said tearfully in an interview.

Abbygail’s parents now question whether the surgery center ever should have been willing to treat their daughter.

Risky Patients

Because surgery centers have less safety equipment and staffing than hospitals, industry leaders stress the importance of selecting patients healthy enough to fare well. Their predictions, though, are not always correct.

Abbygail, who loved her hand-me-down blanket and the film “Frozen,” had sleep apnea, an irregular heartbeat and was very heavy for her age, according to the lawsuit.

Sleep apnea increases the risk of serious complications in surgery and the night after, medical research shows. Given her condition, Abbygail “should have been admitted [to a hospital] and monitored post-procedure,” said Dr. Charles Cote, a retired Harvard pediatric anesthesiology professor who was not involved in the family’s lawsuit.

The lawsuit says Abbygail’s risk factors “were documented and known by the Defendants,” including the doctor. It said the toddler should have been operated on “in an inpatient setting under hospital care and monitored overnight.”

Dr. Michael Marsh performed Abbygail’s tonsillectomy at Executive Park Surgery Center in Fort Smith, Ark.

The surgery center’s lawyer declined to comment. The doctor’s lawyer did not return email and voice messages. In court documents responding to the lawsuit, Marsh and the center denied wrongdoing.

In the court filing, Marsh said the toddler’s injuries were “the natural progression” of her illness. Executive Park Surgery Center said in a court filing that “no action on their part … was a proximate cause of any damages or injury.” The case was settled.

In at least 25 cases, surgery centers opened their doors to ailing and fragile patients who died after simple procedures, such as tonsillectomies, retinal repairs or colonoscopies, KHN and USA TODAY Network found.

Medicare asks surgery centers to assess each patient’s risk, but inspectors flagged 122 surgery centers in 2015 and 2016 alone for lapses in risk assessments. Some centers failed to gauge risk at all. Others overlooked their own policies.

Doctors can use an anesthesia risk assessment to screen out fragile patients — healthy patients get a score of 1, and a score of 5 means a person is nearly dead.

A few states, including Pennsylvania and Rhode Island, bar certain surgery centers from operating on patients with an anesthesia risk score of 4. But most states don’t go that far. They leave such decisions up to doctors.

And some of those decisions have been cited in tragic outcomes. Sabino Sifuentes, 74, had survived triple-bypass surgery. But on March 23, 2015, nine minutes after the start of anesthesia for an eye procedure, he became unresponsive, never to be revived, according to a Medicare inspection report. A nurse anesthetist who reviewed the case at Eye-Q Vision Care’s surgery center in Fresno, Calif., told state health inspectors that Sifuentes should have been given a risk score of 4 and his care was “completely mismanaged,” the inspection report says.

In response to the family’s lawsuit, the surgery center said Sifuentes’ injury was caused by his own negligence and others’.

Five other patients with the same risk score died after routine procedures at surgery centers across the U.S.

A Widening Niche

Such tragedies rarely find their way into the discussion when Medicare decides whether to approve new procedures at surgery centers.

Take spinal surgery.

Until 2015, Medicare wouldn’t pay for it at surgery centers. Then, the industry’s trade association urged the agency to make the change, and encouraged a letter-writing campaign from surgery centers across the nation.

Letter writers included Dr. Alan Villavicencio, a Colorado surgeon who said he’d been doing such surgeries for 12 years and found that his patients “appreciate the convenience and cost savings.” He did not mention that James Long, 56, had died three weeks earlier at a Lafayette, Colo., surgery center where he is an owner, a review of Colorado health department and medical board records shows.

United Surgical Partners International, a surgery center chain, also weighed in urging even more procedures to be approved, not mentioning a patient death hours after a spine surgery at one of its affiliate centers several months before, according to court records and securities filings. The chain said in a statement that it stands behind its comments in support of the proposal.

Such letters carry weight with Medicare, which approves procedures to be done in surgery centers based on the invasiveness and complexity of the surgery and on input from stakeholders.

Robert Beatty-Walters, a Portland, Ore., attorney who has represented the families of three people who died after surgery center spine procedures, said Medicare’s decision-making process is not even-handed.

“The stakeholders — they call them — during these regulatory proceedings are the profit-makers, not the people who are being provided the service,” he said. “The spine centers just want to have more people come. They make more money. I hate to be that cynical about it, but that’s just what I’ve seen.”

Medicare approved 10 spine-surgery codes to be billed at surgery centers starting in 2015 and added more spinal procedures for 2017. A Medicare spokesman denied a request for a telephone interview. In an email, a spokeswoman said Medicare opened the spine proposal to the public and received no comments suggesting the procedures would pose a threat to Medicare patients. She said the final decision about where a patient will have surgery is up to a doctor and patient.

By 2017, at least 14 patients had died soon after spine operations at surgery centers, according to the KHN/USA TODAY Network investigation.

The 14 spine-surgery deaths have gleaned little recognition in the industry or beyond. Only one made headlines in local newspapers. The rest are documented in places like the Macon, Ga., courthouse or in obscure regulatory reports. And there may be far more because some states, including New York, Illinois and Florida, disclose no details about surgery center deaths.

Paulina Tam’s death at Fremont Surgery Center was a tragic example. At 58, the mother of three had finished careers as a nurse and an educator. Next, she planned to travel the world with her husband of 32 years.

“She was the driving force of the family, the spirit I guess,” said her son, Eric Tam, a doctor in New York City, said. “We didn’t expect the worst to happen.”

The care she received at the center is documented in court records, EMS reports and a Medicare inspection report that concluded that the center “failed to provide a safe environment for surgery.”

Tam’s doctor scheduled her for a procedure to replace two discs in her upper spine on April 7, 2014. Pain from a car crash had bothered her for years. Any such surgery — entering the front of the neck to address pain in the spine — comes with a risk of suffocation, according to the Medicare inspection report.

Yet, with her surgeon and anesthesiologist already gone, the only doctor on-site was a digestive health specialist, the inspection report shows. About four hours after her procedure, Tam told a nurse that her surgical collar felt too tight. Then, that she couldn’t breathe.

The nurse called a “code blue” just after 6:30 p.m., records say.

Medical experts say the first step in helping such patients is removing the surgical staples so the pooled blood can disperse, allowing the patient to breathe.

In Tam’s case, staff repeatedly tried and failed to insert a breathing tube through her mouth and into her airway, the inspection report shows. A last-ditch remedy would have been to punch a hole through the front of her throat to restore breathing, but the gastroenterologist later told an inspector that he was “not prepared” to do so.

The inability to perform the suffocation-rescue maneuver, the inspection report says, amounted to the center’s “failure to ensure patient safety.”

From the time a nurse called 911, it took 24 minutes to get Tam to the nearest hospital, EMS records show. She arrived without a pulse and remained on life support overnight, as her children raced to her bedside to say goodbye.

The center did not return calls and denied wrongdoing in the court case. Tam’s surgeon declined to discuss the case but filed pleadings in court saying Tam’s “carelessness and negligence” caused her death. It’s unclear what the defense meant by negligence. The case reached a confidential settlement.

After Tam’s death, the center told Medicare inspectors that a qualified doctor would stay on-site after all upper-spine cases.

Dr. Nancy Epstein, chief of neurosurgical and spine care at New York University Winthrop Hospital, said surgery centers doing delicate work near the spinal cord, windpipe and esophagus in a same-day procedure is “pretty revolting.” But she said the centers are making so much money — “reeling it in hand over fist” that the potential dangers are being ignored.

“Medically, it should not be tolerated,” she said, “but it is.”