KFF Health News

KFF Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

California Surprise-Billing Law Protects Patients But Aggravates Many Doctors

KFF Health News, December 5, 2019

Physicians say the law's constraints on what insurers now pay has given the companies an unfair advantage in negotiations with doctors, which is leading to major changes in the industry that may affect patients.

This article was published December 5, 2019, by Kaiser Health News.

By Michelle Andrews

More than two years after California's surprise-billing law took effect, there's one thing on which consumer advocates, doctors and insurers all agree: The law has been effective at protecting many people from bills they might have been saddled with from doctors who aren't in their insurance network.

But the consensus stops there.

"In general, the law is working as intended," said Anthony Wright, executive director of Health Access California, a patient advocacy group that pushed for the measure, AB-72. "Patients are protected and the providers are getting paid."

Physicians beg to differ. They say the law's constraints on what insurers now pay has given the companies an unfair advantage in negotiations with doctors, which is leading to major changes in the industry that may affect patients.

Recent analyses by some researchers, however, cast doubt on some of the doctors' dire warnings.

"The problem is that AB-72 is creating imbalances in the health care marketplace that are decreasing access to care," said Dr. Antonio Hernandez Conte, an anesthesiologist whose specialty is among those most affected by the law.

The California law, which took effect in July 2017, protects consumers who use an in-network hospital or other facility from being hit with surprise bills when cared for by a doctor who has not contracted with their insurer. If that happens, consumers are responsible only for the copayment or other cost sharing that they would have owed if they had been seen by an in-network doctor.

Federal lawmakers are eyeing the California law as a possible model as they debate legislative proposals that would address surprise billing at the national level.

The California law applies to nonemergency services, since most state consumers were already protected for emergency care through an earlier court ruling.

It's not unusual for patients who visit a hospital or ambulatory surgical center that is covered by their insurance to encounter specialists who aren't, even in nonemergency situations.

For example, someone who has knee replacement surgery with an in-network surgeon at an in-network hospital may not realize that the anesthesiologist and assistant surgeon also scrubbing in on the operation are not.

Or a couple may be surprised to learn that the neonatologist caring for their baby in intensive care is outside their insurance network, even though the hospital where they gave birth is inside it. Diagnostic specialists like radiologists and pathologists whom patients rarely see may be out-of-network at an in-network hospital as well.

Under the California law, the doctor's payment from an insurer in those situations is based on either the average contracted rate for similar services in the area or 125% of what Medicare would have paid, whichever is greater.

In a California Medical Association online survey released last month ― in which 855 physician practices responded ― nearly 90% of the doctors said that the law allowed insurers to shrink physician networks, thus limiting patients' access to in-network doctors. Physicians blame the new law's reimbursement rates for surprise out-of-network care. The payment standard made insurers less inclined to negotiate payments and reduced doctors' bargaining power, the physicians say.

Those surveyed said they faced insurer payment rate cuts, refusal to renew their contracts and contract termination, among other problems.

This has led some physicians to try to gain leverage by consolidating practices, a move that can drive up health care costs significantly, the doctors warn.

The medical association did not respond to calls for comment on the survey.

Hernandez Conte, who chairs the legislative and practice affairs division of the California Society of Anesthesiologists, also pointed to data from the California Department of Managed Health Care showing that consumer complaints about access to care have risen from 415 in 2016 to 614 in 2018, a 48% jump.

Those complaints represent a minuscule number of consumers in the context of the more than 30 million Californians covered by commercial insurance or Medi-Cal, said Loren Adler, associate director at the University of Southern California-Brookings Schaeffer Initiative for Health Policy. Adler noted that there's no way to know if the complaints had anything to do with the surprise-billing law.

Hernandez Conte also pointed to a study published in August by the research firm Rand Corp. that he said showed the law is eroding doctors' leverage with insurers.

But that study ― a series of 28 interviews with doctors and others about their experiences in the first year after the law took effect ― wasn't definitive, said author Erin Duffy, an adjunct policy researcher at Rand and postdoctoral fellow at the Schaeffer Center for Health Policy and Economics at USC.

"It's more a reflection of what are some of the potential things we should look at down the road," she said.

Aside from individual examples of contracting problems cited by the physician group, researchers cite little evidence that patients are losing access to doctors who accept their insurance because of dwindling insurance networks.

The opposite appears to be true. USC-Brookings researchers published an analysis in September examining more than 17 million specialty claims by California physicians affected by the law. They found the share of services that specialty physicians delivered out-of-network at hospitals and ambulatory surgical centers declined by 17% after the law took effect.

When the law went into effect, there was a "precipitous" movement by affected physicians into insurance networks, said Adler, a co-author of the study.

Similarly, when the trade group America's Health Insurance Plans surveyed 11 large California health insurers about in-network providers during the two years after the law took effect, it found that the numbers grew or remained flat across specialties. There was a 16% increase in the number of in-network physicians overall, including a 26% rise in diagnostic radiologists and an 18% bump in anesthesiologists.

The plight of consumers who go to an in-network facility and, unbeknownst to them, receive treatment from out-of-network doctors has garnered plenty of attention in recent months.

In a typical scenario, the doctor charges the insurance company for services, then turns around and bills the patient for whatever amount the insurance company doesn't pay, a practice called balance billing. With no contract between the insurer and the doctor to set payment rates, the amounts billed by physicians are often higher than market rates, and the balance bills that patients face are many times higher than the regular copayment they would owe for in-network care.

Federal lawmakers are debating a number of measures that would address the issues at the federal level. The leading House and Senate bills would set minimum payment standards based on insurers' median in-network rate for a service for applicable out-of-network care, similar to the California law.

A federal law is key to broadening the surprise-billing protections provided by California's law, Wright said.

More than half of states now provide some level of consumer protection against surprise bills, and the efforts vary. But state surprise-billing laws protect only people insured by state-regulated plans. In California, that means 5.5 million consumers whose employers self-fund workers' health claims directly, rather than through an insurance plan, aren't covered by the law.

Since AB-72 was implemented, the Department of Managed Health Care hasn't taken any enforcement actions against physicians for balance-billing patients in nonemergency situations, according to agency spokeswoman Rachel Arrezola. It has pursued a handful of cases against doctors for out-of-network balance billing in emergency situations, however.

As doctors and patient advocates wrangle over AB-72, lawmakers are pressing new protections for consumers. A state law recently barred balance billing by air ambulance services.

Starting in January, California consumers who are airlifted by an out-of-network air ambulance won't be responsible for any more than their regular cost sharing for in-network providers.

An Atlanta Nonprofit Brings Medical Care And Connection To The Homeless

KFF Health News, December 4, 2019

It's a public health strategy that can be found in dozens of cities in the United States and around the world.

This article was published December 4, 2019, by Kaiser Health News.

By Sam Whitehead, WABE

Herman Ware got his seasonal flu shot while sitting at a small, wobbly table inside a mobile health clinic. The clinic-on-wheels is a large converted van, and on this day it was parked on a trash-strewn, dead-end street in downtown Atlanta where homeless residents congregate.

The van and Ware’s flu shot are part of a “street medicine” program designed to bring health care to people who haven’t been able to pay much attention to their medical needs. For those who struggle to find a hot meal or a place to sleep, health care can take a back seat.

As he anticipated the needle, Ware recalled previous shots and said, “It might sting.” He grimaced slightly as the nurse injected his upper arm.

After filling out paperwork, he climbed down the van’s steps and walked back to a small cluster of tents. Ware lives in the nearby homeless encampment tucked below an interstate overpass, next to a busy rail line.

Mercy Care, a health care nonprofit in Atlanta, operates brick-and-mortar clinics throughout the city that mainly treat poor residents. Since 2013, Mercy has also sent out teams of health care providers to treat homeless people.

It’s a public health strategy that can be found in dozens of cities in the United States and around the world, according to the Street Medicine Institute, which works to spread the practice.

Relationship Leads To Care

Getting homeless patients to accept help, whether it’s a vaccination or something simpler — like a bottle of water — can be challenging. And giving shots and conducting exams outside the walls of a health clinic often requires a different approach to health care.

“When we’re coming out here to talk to people, we’re on their turf,” said nurse practitioner Joy Fernandez de Narayan, who runs Mercy Care’s Street Medicine program.

“We’ll sit down next to someone, like, ‘Hey, how’s the weather treating you?'” she said.

“And then kind of work our way into, like, ‘Oh, you mentioned you had a history of high blood pressure. Do you mind if we check your blood pressure?'”

It can take several encounters to gain someone’s trust and get them to accept medical care, so the outreach workers spend a lot of time forging relationships with homeless clients.

Their persistent encouragement was helpful for Sopain Lawson, who caught a debilitating foot fungus while living in the encampment.

“I couldn’t walk,” Lawson said. “I had to stay off my feet. And the crew, they took good care of my foot. They got me back.”

“This is what street medicine is about — going out into these areas where people are not going to seek attention until it’s an emergency,” said Matthew Reed, who’s been doing social work with the team for two years.

“We’re trying to avoid emergencies, but we’re also trying to build relationships.”

‘Go To The People’

The street medicine team members use the trust they’ve built with patients to eventually connect them to other services, such as mental health counseling or housing.

Access to those services may not be readily available for many reasons, said Dr. Stephen Hwang, who studies health care and homelessness at St. Michael’s Hospital in Toronto.

Sometimes the obstacle — not having money for a bus ticket, for example — seems small, but is formidable.

“It may be difficult to get to a health care facility, and often there are challenges, especially in the U.S., where people [may not] have health insurance,” Hwang said.

Georgia is among a handful of states that have not expanded Medicaid to all low-income adults, which means many of its poorest residents don’t have access to the government-sponsored health care program.

But even when homeless people are able to get health coverage and make it to a hospital or clinic, they can run into other problems.

“There’s a lot of stigmatization of people who are experiencing homelessness,” Hwang said, “and so often these individuals will feel unwelcome when they do present to health care facilities.”

Street medicine programs are designed to break down those barriers, said Dr. Jim Withers.

He’s the medical director of the Street Medicine Institute and started making outreach visits to the homeless in 1992, when he worked at a clinic in Pittsburgh.

“Health care likes people to come to it on its terms,” Withers said, while the central tenet of street medicine is, “Go to the people.”

Help And Respect

Mercy Care in Atlanta spends about $900,000 a year on its street medicine program. In 2018, that sum paid for direct treatment for some 300 people, many of whom got services multiple times. Street clinics can help relieve the care burden of nearby hospitals, which Withers said don’t have a great track record in treating the homeless.

“We’re not dealing with them well,” Withers said, speaking about American health care in general. In traditional health settings, homeless patients do worse compared with other patients, he said.

Those extra days and clinical complications mean additional costs for hospitals. One estimate cited in a 2017 legislative report on homelessness suggested that more than $60 million in medical costs for Atlanta’s homeless population were passed on to taxpayers.

Mercy Care said its program makes homeless people less likely to show up in local emergency rooms and healthier when they do — which saves money.

It’s past sundown when the street medicine team rolls up to the day’s final stop: outside a church in Atlanta where the homeless often gather. A handful of people have settled down for the night on the sidewalk. Among them is Johnny Dunson, a frequent patient of the Street Medicine program.

Dunson said the Mercy Care staffers have a compassionate style that makes it easy to talk to them and ask for help.

“You gotta let someone know how you’re feeling,” Dunson said. “Understand me?

Sometimes it can be like behavior, mental health. It’s not just me. It’s a lot of people that need some kind of assistance to do what you’re supposed to be doing, and they do a wonderful job.”

Along with medical assistance, the staff at Mercy Care give patients doses of respect and dignity.

This story is part of a partnership that includes WABE, NPR and Kaiser Health News.

Medical Device Failures Brought To Light Now Bolster Lawsuits And Research

KFF Health News, December 3, 2019

For nearly two decades, malfunctions and injuries linked to more than 100 medical devices were funneled into an FDA database that few patients, doctors or even FDA officials knew existed.

By Christina Jewett

Lorraine Bonner felt as though she was the only one. The surgical staples used to seal her colon after surgery had leaked, she has alleged in a lawsuit, spurring additional surgeries and a long, difficult recovery.

And then, just over a year after the ordeal, she read a Kaiser Health News investigation that described worse cases. KHN revealed that the Food and Drug Administration had allowed stapler maker Covidien to quietly file tens of thousands of reports of stapler malfunctions into a then-hidden database.

Alarmed that others had been harmed and reports had been hidden, Bonner, a retired Oakland, Calif., doctor, decided to go forward with a lawsuit against the stapler maker.

"If the information had been out there, then maybe Covidien would have changed the design of the staplers and made them safer," she said, "and that would have obviated the problem in the first place."

Bonner's lawsuit is one example of how a vast cache of records that were released this summer are taking on a life of their own.

For almost 20 years, malfunctions and injuries linked to 108 medical devices, including dental implants and pacemaker leads, were funneled into an FDA database that few patients, doctors or even FDA officials knew existed.

In 2016, for example, Covidien reported 84 injuries or malfunctions in the public database known as MAUDE, while nearly 10,000 incidents flowed into the hidden database, KHN reported in March. A few MAUDE reports mentioned the existence of an "alternative summary reporting" program, but until this summer, the FDA made that internal data available only through the Freedom of Information process, which can take up to two years.

KHN's investigation prompted then-FDA commissioner Scott Gottlieb to pledge in a tweet to open the hidden data to the public. The agency released all 5.7 million records in June.

Since then, researchers, lawyers and the FDA's own officials have taken a closer look at the data to learn more about which devices malfunctioned, and how often.

Libbe Englander, the founder and CEO of Pharm3r, a medical data consulting firm, discovered that the devices in the hidden database were much riskier than other devices tracked by the FDA.

Her firm concluded that the hidden reports were "more likely to be associated with life-threatening devices and to contain potentially serious problems."

For example, just 10% of the devices tracked in the MAUDE database are implanted in the body. But 44% of those in the hidden data are lodged in a patient's body, including pacemakers and heart valves.

The Pharm3r report also found that the devices in the hidden data were more likely to be subject to a Class 1 recall, initiated when a device problem could cause serious injury or death. The report also underscored how vast the now-open data is ― accounting for about 40% of the total device-problem reports lodged with the FDA over the past two decades.

The once-hidden reports also figured into the ECRI Institute's annual list of health technology hazards, a list circulated to hospitals and health systems.

ECRI found that this year's No. 1 hazard was misuse of the surgical stapler ― which has been linked to 412 deaths, more than 11,000 serious injuries and nearly 100,000 malfunctions since 2011, according to the FDA.

"Most of these [stapler] reports had not previously been accessible to the public," the ECRI report notes. ECRI has advised doctors to have a backup plan in place in case a stapler malfunctions during surgery.

"If a hazard is getting a lot of attention, hospitals want to have a plan to address that," said Rob Schluth, a senior project officer with the institute.

Bonner says her long, difficult recovery after several surgeries kept her from tending to her garden for about a year. (Heidi de Marco/KHN)[/caption]

For Bonner, the problems with a surgical stapler became apparent just over a week after she had colon surgery in November 2017. Retired from a career as a hospital physician, she knew the steps to take toward recovery. But she felt nauseated all the time and could barely hold down water.

"I was trying to get up and walk," she said. "I was doing everything, but I just got worse and worse."

Doctors went in for a second surgery on Dec. 6 and found infected pus filling her abdomen. They routed her colon's contents to be collected outside her body. It took additional surgeries to restore her colon function and address hernias caused by the procedures.

Bonner's lawsuit alleges that a Covidien stapler caused her bowel leak and that the company, by not reporting malfunctions to the public database for years, "have hidden the true risks of using the device from surgeons and patients."

In court records filed in the ongoing case, Covidien denied all of Bonner's claims but did say that the FDA invited the company in 2001 to submit stapler malfunctions with quarterly "alternative summary" reports.

Medtronic spokesman John Jordan said the company does not have a comment on the pending legal case.

Other devices are under scrutiny. The once-hidden data showed more than 2 million problems with dental implants.

During an October FDA webinar on dental devices, an FDA official said her office was "taking a deeper dive and trying to identify lessons learned" from dental implant incidents.

Dr. Malvina Eydelman, of the Division of Dental Devices in the agency's device branch, acknowledged that the number of events was "very high" and said her team was trying to develop a plan to share information with the public.

Also under scrutiny are the textured breast implants made by Allergan. The company's Biocell implants, recalled in July, have been linked to 12 deaths and 481 of the 573 worldwide cases of "breast implant-associated" lymphoma, according to the FDA. Breast implant injuries and malfunctions accounted for nearly half a million reports in the hidden database, including implants that leaked, deflated or migrated.

Patients in Missouri, California, New York and Illinois have filed federal class action lawsuits against Allergan in recent weeks, each decrying the company's heavy use of the "alternative summary reporting" program to file injury reports ― which were analyzed by the International Consortium of Investigative Journalists.

A class action case filed in Florida notes FDA rules say that alternative summary reports cannot include severe or unexpected events, "yet it is believed that these incidents were kept hidden in ASRs," including at least one lymphoma case.

An ongoing federal securities lawsuit also alleges that Allergan used "inappropriately nonpublic" alternative summary reports, disregarding the "risk that some [lymphoma] cases would go undetected by the FDA."

Allergan has not yet responded to the class action cases or to calls for comment. It denied the "threadbare" allegation in the securities lawsuit, citing the KHN article, which "makes clear that the filing of ASRs was permissible and even encouraged by the FDA to reduce 'redundant paperwork.'"

While the FDA has ended the alternative summary reporting program, it opened the door for makers of more than 5,000 device types to file quarterly summaries of reported malfunctions. In each case, the device maker must file a public report to the MAUDE database noting how many reports were filed directly with the agency.

An FDA spokeswoman said the agency has stopped accepting summary reports of injuries cited in pelvic mesh lawsuits. The agency does continue to accept hundreds of death report summaries under a special exemption for devices tracked in a "registry" held by a specialty medical society.

"We are in the process of reviewing the effects of these changes and will continue working to improve the usability and transparency of information in the MAUDE database — whether that information was submitted as a summary or individual report," FDA spokeswoman Stephanie Caccomo said in an email.

The release has not been as informative as Madris Tomes had hoped, she said, given that the FDA did not disclose data on how the devices harmed patients. Tomes is a former FDA manager who runs the company Device Events, which analyzes FDA data.

For instance, she said a breast implant injury report might say there was a "biocompatibility" problem, but it's unclear what happened to the patient.

"Did it result in lymphoma or the patient needing a device replacement?" asked Tomes. "Without that outcome, we're still a little bit in the dark on what this data means."

'I Feel Like I'm In Jail': Hospital Alarms Torment Patients

KFF Health News, December 2, 2019

Nearly every machine in a hospital is now outfitted with an alarm. The glut of noise means that the medical staff is less likely to respond.

This story, which ran in The Washington Post, was published December 2, 2019, by Kaiser Health News.

By Melissa Bailey, Kaiser Health News

When Kea Turner's 74-year-old grandmother checked into Virginia's Sentara Virginia Beach General Hospital with advanced lung cancer, she landed in the oncology unit where every patient was monitored by a bed alarm.

"Even if she would slightly roll over, it would go off," Turner said. Small movements ― such as reaching for a tissue ― would set off the alarm, as well. The beeping would go on for up to 10 minutes, Turner said, until a nurse arrived to shut it off.

Tens of thousands of alarms shriek, beep and buzz every day in every U.S. hospital. All sound urgent, but few require immediate attention or get it.

Intended to keep patients safe alerting nurses to potential problems, they also create a riot of disturbances for patients trying to heal and get some rest.

Nearly every machine in a hospital is now outfitted with an alarm ― infusion pumps, ventilators, bedside monitors tracking blood pressure, heart activity and a drop in oxygen in the blood. Even beds are alarmed to detect movement that might portend a fall. The glut of noise means that the medical staff is less likely to respond.

Alarms have ranked as one of the top 10 health technological hazards every year since 2007, according to the research firm ECRI Institute. That could mean staffs were too swamped with alarms to notice a patient in distress, or that the alarms were misconfigured. The Joint Commission, which accredits hospitals, warned the nation about the "frequent and persistent" problem of alarm safety in 2013. It now requires hospitals to create formal processes to tackle alarm system safety, but there is no national data on whether progress has been made in reducing the prevalence of false and unnecessary alarms.

The commission has estimated that of the thousands of alarms going off throughout a hospital every day, an estimated 85% to 99% do not require clinical intervention. Staff, facing widespread "alarm fatigue," can miss critical alerts, leading to patient deaths. Patients may get anxious about fluctuations in heart rate or blood pressure that are perfectly normal, the commission said.

And bed alarms, a recent arrival, can lead to immobility and dangerous loss of muscle mass when patients are terrified that any movement will set off the bleeps.

An 'Epidemic Of Immobility'

In the past 30 years, the number of medical devices that generate alarms has risen from about 10 to nearly 40, said Priyanka Shah, a senior project engineer at ECRI Institute. A breathing ventilator alone can emit 30 to 40 different noises, she said.

In addition to triggering bed alarms, patients who move in bed may set off false alarms from pulse oximeters, which measure the oxygen in a patient's blood, or carbon dioxide monitors, which measure the level of the gas in someone's breath, she said.

Shah said she has seen hospitals reduce unneeded alarms, but doing so is "a constant work in progress."

'Cry Wolf Phenomenon'

Maria Cvach, an alarm expert and director of policy management and integration for Johns Hopkins Health System, found that on one step-down unit (a level below intensive care) in the hospital in 2006, an average of 350 alarms went off per patient per day, from the cardiac monitor alone.

She said no international standard exists for what these alarms sound like, so they vary by manufacturer and device. "It's really impossible for the staff to identify by sound everything that they hear," she said.

The flood of alarms creates a "cry wolf phenomenon," Cvach said. The alarms are "constantly calling for help. The staff look at them. They say that's just a false alarm ― they may ignore the real alarm."

Bed alarms, for example, are meant to summon nurses so they can supervise patients to walk safely. But research has shown that the use of alarms doesn't prevent falls. Nursing staffs are often stretched thin and don't reach the bedside before a patient hits the ground.

Meanwhile, patients may feel immobilized at a time when even a few hundred steps per day could significantly improve their recovery. Immobility in the hospital can create other problems for patients, leaving them with often irreversible functional decline, research has shown.

Bed alarms have proliferated since 2008, when the Centers for Medicare and Medicaid Services declared hospital falls should "never" happen and stopped paying for injuries related to those falls. After that policy change, the odds of nurses using a bed alarm increased 2.3 times, according to a study led by Dr. Ronald Shorr, director of the Geriatric Research, Education and Clinical Center at the Malcom Randall Veterans Affairs Medical Center in Gainesville, Fla. The alarms have become a standard feature in new hospital beds.

But Shorr noted that, in contrast, bed alarms are being removed from other settings: In 2017, CMS began discouraging their widespread use in nursing homes, arguing that audible bed or chair alarms may be considered a "restraint" if the resident "is afraid to move to avoid setting off the alarm."

Barbara King, an associate professor at the University of Wisconsin at Madison School of Nursing, who has interviewed patients about their experience with bed alarms, said patients find them "very restrictive."

"They're loud. For some patients, it's frightening. They don't know where it's coming from. It's a source of irritation," she said. "For some patients, they won't move."

Seeking Solutions

Hospitals have turned to "clinical alarm management," bringing in consultants to figure out how many devices have alarms, which go off most frequently and which are the most important for nurses to respond to. Hospitals are also installing sophisticated software to analyze and prioritize the constant stream of alerts before relaying the information to staff members.

The U.S. market size for the management of clinical bed alarms, in hospitals and other settings, has grown from $21.4 million in 2016 to $37.4 million in 2018, according to an analysis by MarketsandMarkets. The firm projects the market size will quadruple to $155.5 million by 2023.

For ventilators, it estimates the U.S. market for clinical alarm management will quadruple from $19.9 million in 2018 to $80.2 million by 2023.

In Virginia, Kea Turner's grandmother grew so frustrated with her bed alarm that she gave up on sleeping and stayed up late watching television during her hospital stay, said Turner, a researcher at the Moffitt Cancer Center in Florida who studies, among other things, patient safety.

Many hospitals, she said, don't seem to have evidence-based strategies to reduce falls and, "in the absence of those, they're using things like bed alarms," she said, which "is not necessarily reducing falls risk and might actually be causing more harm."

Dr. Joel Bundy, chief quality and safety officer at Sentara Healthcare, a not-for-profit health system that includes the Virginia Beach hospital, said nurses in that oncology unit decided to use bed alarms for all patients at night because of a high number of falls. But he said Sentara typically employs bed alarms only for patients who are deemed at a high risk of falling, based on a questionnaire developed at Johns Hopkins.

Meanwhile, some hospitals are trying to quiet the noise.

By customizing alarm settings and converting some audible alerts to visual displays at nurses' stations, Cvach's team at Johns Hopkins reduced the average number of alarms from each patient's cardiac monitor from 350 to about 40 per day, she said.

But that's just one device in one unit; other devices and types of care require different customized settings.

Still, Cvach said, "a lot more can be done."

Dr. Fred Buckhold, an internist at SSM Health St. Louis University Hospital in Missouri, said one patient's experience spurred his hospital to reduce reliance on bed alarms.

A 67-year-old woman was placed on a bed alarm while being treated for a collapsed lung, said Buckhold, who wrote about the case in JAMA.

"I feel like I'm in jail," she protested, Buckhold said. "I can't sit up or go to the bathroom without them coming after me."

"Did the bed alarm help her at all?" Buckhold reflected in a recent interview. "It just made her want to kill us."

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Coping With (Power) Loss: California's Hospitals, Clinics, Patients Face New Reality

KFF Health News, December 2, 2019

The outages are likely to be a long-term problem. Hospitals and clinics must be prepared for this new reality. And so must patients.

This story was published by Kaiser Health News on November 27, 2019.

By Mark Kreidler

We all know that when the power goes out, refrigerators, heaters and air conditioners stop running. Homes go dark, and desktop computers shut down.

But those are mere inconveniences. If you need regular dialysis or chemotherapy at a clinic, or you have an infant in a neonatal intensive care unit or a loved one on a hospital ventilator, a loss of power carries far more dire implications.

California's recurrent power outages this year by Pacific Gas & Electric Co. and Southern California Edison, in response to wildfire threats up and down the state, have forced patients to think about how they get care when the power is cut at hospitals and clinics.

Hospitals that provide critical care are required by state and federal law to have backup generators on-site. In California, hospitals, outpatient clinics and treatment centers have long-standing disaster plans in place, which cover the possibility of temporary power outages.

"But continuous power shut-offs, sometimes lasting for days and then happening again within a week or two, were never what those plans were intended for," said Jan Emerson-Shea, vice president for external affairs at the California Hospital Association. "This is all very new to everybody."

Communities in Northern and Southern California have been subjected this year to numerous outages, often with no assurance of when their power would be restored. The utilities' estimates sometimes miss the mark. The outages are likely to be a long-term problem, given PG&E's 10-year timetable for fixing power transmission risks.

And the fires are not necessarily finished for this season: The Camp Fire, the most deadly in California history, started in the second week of November last year. And the Thomas Fire, a huge blaze that ravaged swaths of Ventura and Santa Barbara counties, erupted in early December 2017 and burned well into January.

The bottom line: Hospitals and clinics must be prepared for this new reality. And so must patients. The following answers to some critical questions will help readers understand what patients' options will be the next time a vital treatment is threatened by a loss of power.

Q: We have a family member on a ventilator in the hospital. What happens to her if the power goes out?

She will likely not be affected. All California hospitals must have backup generators and enough diesel fuel on hand to run for 72 hours without electricity. The generators kick in within 10 seconds of a power shut-off, Emerson-Shea said, so all critical functions — ventilators, heart monitors, surgical procedures — can continue without interruption.

Q: Some recent outages have lasted longer than 72 hours. What happens then?

As long as the hospital has access to diesel fuel, it can run on its generators for as long as it needs to (although air quality issues arise from their prolonged use). But even with generators, hospital administrators must decide which services are absolutely critical and which ones are temporarily dispensable.

Q: What are some examples of both?

If you have elective surgery like a knee replacement scheduled, and power is expected to be cut off that day, there's a chance the hospital will reschedule the operation. The generators are intended primarily to power the critical-care functions of a hospital — operating and emergency rooms; labor centers; the monitoring of patients' heart rates, breathing and blood pressure — and officials will keep those functions going even if it means turning off the building's air conditioning or heat.

Q: I have a chemotherapy treatment scheduled on a day when a power shut-off may occur. Should I still go?

That depends on your provider. Many oncology practices are located within or next to hospitals, so they would retain access to power even in a shut-off. The situation changes, though, if your treatments are normally provided at a free-standing health clinic or private care center, where such backup may not exist. A survey by the disaster-preparedness nonprofit Direct Relief found that only 44% of California's community health centers have a backup energy source in case of electrical failure.

Q: What do clinics without backup energy do, then, if the power goes out?

Phone calls by California Healthline to several such clinics found that most of them had a similar plan: Staffers use their cellphones to contact each patient and cancel his or her session. So be aware that you may see an unfamiliar incoming number that turns out to be your provider. If someone from your treatment team doesn't call you, call them. And if your treatment is canceled, make sure it is rescheduled for immediately after power is restored. A few of the facilities noted that their doctors have privileges at local hospitals, so in cases where the treatment is indispensable, they can send patients there. Emerson-Shea said several hospitals have reported receiving patients who had been directed there by clinics.

Q: How bad is it if I miss a chemo or radiation treatment?

In many cases, a delay of a few days won't hurt you. But missing a session altogether is not good. A study published by the National Institutes of Health showed that missed chemotherapy doses correlated with worse prognoses and higher mortality rates among cancer patients. Missed radiation treatments, likewise, have been linked to a greater risk of cancer recurrence. So it's important to stay on track.

Q: What about dialysis? If my clinic has no power, can I get treatment elsewhere?

Yes. During mandatory fire-related evacuations in Sonoma County last month, some clinics with no formal affiliation functioned as ad hoc cooperatives, cross-referring their patients depending upon which facilities were up and running, said Monica Hannaman, a dialysis social worker at Fresenius Medical Care in Santa Rosa. The goal was to treat patients without having to send them to a hospital, she said, "because the hospitals are already so burdened during emergencies like that."

Also, keep in mind that if your dialysis center is part of a bigger chain, you can go to one of its other locations. Some Sonoma County dialysis patients of San Jose-based Satellite Healthcare, which has multiple locations in California, went as far as Sacramento for treatment last month, said Lanie Borja, manager of the Satellite clinic in Windsor, Calif.

Q: What else can health care providers do to ensure my well-being in the likely case of future power outages?

Hospitals may start rethinking ways to store backup energy, Emerson-Shea said, especially given the long time PG&E has said it will take before it can stop the precautionary outages. Some free-standing medical clinics in areas with high fire and wind risk are considering buying generators large enough to power their operations, despite the big expense. Hannaman said Fresenius is thinking of putting generators in its two Santa Rosa-area clinics, because "this will be happening more often, we're afraid."

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

Coping With (Power) Loss: California's Hospitals, Clinics, Patients Face New Reality

KFF Health News, November 27, 2019

The Golden State's recurrent power outages this year in response to wild fires have forced patients to think about how they get care when the power is cut.

This article was first published on Wednesday, November 27, 2019 in Kaiser Health News.

By Mark Kreidler

We all know that when the power goes out, refrigerators, heaters and air conditioners stop running. Homes go dark, and desktop computers shut down.

Q: We have a family member on a ventilator in the hospital. What happens to her if the power goes out?

Q: Some recent outages have lasted longer than 72 hours. What happens then?

As long as the hospital has access to diesel fuel, it can run on its generators for as long as it needs to (although air quality issues arise from their prolonged use). But even with generators, hospital administrators must decide which services are absolutely critical and which ones are temporarily dispensable.

Q: What are some examples of both?

Q: I have a chemotherapy treatment scheduled on a day when a power shut-off may occur. Should I still go?

Q: What do clinics without backup energy do, then, if the power goes out?

Q: How bad is it if I miss a chemo or radiation treatment?

In many cases, a delay of a few days won't hurt you. But missing a session altogether is not good. A study published by the National Institutes of Health showed that missed chemotherapy doses correlated with worse prognoses and higher mortality rates among cancer patients. Missed radiation treatments, likewise, have been linked to a greater risk of cancer recurrence. So it's important to stay on track.

Q: What about dialysis? If my clinic has no power, can I get treatment elsewhere?

Also, keep in mind that if your dialysis center is part of a bigger chain, you can go to one of its other locations. Some Sonoma County dialysis patients of San Jose-based Satellite Healthcare, which has multiple locations in California, went as far as Sacramento for treatment last month, said Lanie Borja, manager of the Satellite clinic in Windsor, Calif.

Q: What else can health care providers do to ensure my well-being in the likely case of future power outages?

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

Last-Minute Loophole Could Undermine Texas Law Against Surprise Medical Bills

KFF Health News, November 25, 2019

State agencies are writing rules that will let providers send patients bills in nonemergency situations, such as scheduled surgeries.

This story was first published on Monday, November 25, 2019 in Kaiser Health News.

By Ashley Lopez, KUT

Texas' bipartisan effort to shield patients from surprise medical bills could be weaker than lawmakers intended when it takes effect Jan. 1.

Earlier this year, lawmakers from both parties came together on legislation to protect people in state-regulated health plans from getting outrageous bills for out-of-network care. The new law, known as Senate Bill 1264, creates an arbitration process for insurers and providers to negotiate fair prices in those cases. The intention of the law is to establish those fair prices without ever involving patients.

But that protection is at risk of becoming "irrelevant," consumer advocates in Texas say.

"The financial struggle that legislators were trying to remove us from ― trying to protect us from ― patients might be right back in the middle of that situation," said Stacey Pogue, a senior policy analyst with the Center for Public Policy Priorities.

State agencies are writing the rules to implement and enforce the new law. Some of those rules, which will be discussed publicly in early December, will let hospitals and other care providers send patients bills in nonemergency situations, such as scheduled surgeries.

One state agency hashing out how the law will work is the Texas Medical Board, which is run by physicians and regulates other doctors in the state. Pogue said the board has proposed a rule that would expand the use of a narrow exception in the law. SB1264 created an exception for patients who knowingly want to receive nonemergency care from a doctor who is out of their health plan's network. In those cases, patients would sign a waiver with the expectation of paying those out-of-network costs.

The board's proposed rule takes that narrow exemption ― intended to be used only when patients want a particular out-of-network doctor ― and instead would require all out-of-network providers in nonemergency situations to give patients that waiver.

In practice, advocates say, the rule could essentially require out-of-network providers — like anesthesiologists and pathologists — to give patients a confusing form that waives their right to the new law's protection. The form would allow the patients to be balance-billed.

"Now it's a loophole," Pogue said. "It's a loophole in the [law] where legislators wanted to give a protection ― a win-win. And now some patients are going to get a lose-lose."

According to the Texas Medical Board, the proposed rules "require an out-of-network provider to provide written notice and disclosure to a patient no less than 10 business days prior to the date of a nonemergency procedure."

"The patient must have five business days to consider whether to accept, and may not agree prior to three business days after the notice was provided," Jarrett Schneider, a board spokesman, said in a statement. "This allows for a cooling-off period so the patient has adequate time to decide whether to proceed if there are, in fact, out-of-network charges."

Pogue said the rule also forces patients to choose between "two terrible outcomes" ― either paying more for providers they didn't choose or forgoing a needed medical procedure.

The proposed rules are expected to be discussed during the board's meeting early next month and could possibly be adopted at that time.

"It creates a path for any provider that wants to continue to send out-of-network bills [and] continue to balance-bill," Pogue said. "It creates a pathway where they can do that."

Schneider maintains that this is not the intent of the proposed rule.

"The Board's proposed rules do not waive any rights a patient has under Senate Bill 1264 or any statute," he said in a statement. "The Board has put forward proposed rules that it believes provide patients with enough advance notice to make a reasoned, economic decision in regards to the care they are receiving."

Jamie Dudensing, CEO of the Texas Association of Health Plans, said in a statement that he believes the proposed rule "misinterprets the law's intent" and makes surprise-billing protections weaker than they were before the law passed.

"Senate Bill 1264 has been praised as the strongest surprise billing law in the country — now we are in danger of making it almost completely irrelevant," Dudensing said. "Instead of allowing for rare exceptions to surprise billing protections, the proposed rule would mandate the exception, resulting in patients losing all surprise billing protections in nonemergency situations."

Blake Hutson, the associate director for the AARP of Texas, said he's most concerned that the rules are vague about how the waiver would work. He said the state has created a unique exception in an effort to give people more freedom in choosing doctors, but it has come with a lot of confusion.

"Other states that have addressed the surprise medical bill issues haven't created an exception for nonemergency, out-of-network physicians like we did," Hutson said.

Among Hutson's concerns are that the proposed rules do not make it clear that providers should mostly rely on the arbitration process set up under the new law to figure out payments. Instead, it requires them to use the proposed form, which various advocates say is hard to understand.

Hutson said the proposed waiver form also doesn't make it clear that patients don't have to sign it. And, he said, there's no clear process for what happens if patients refuse to sign the waiver. Hutson said the medical board should create a way to ensure people can still receive care even if they refuse to be balance-billed.

"This is totally fixable," Hutson said.

Advocates say they are worried that many of these concerns won't be dealt with during the rulemaking process, though, and instead will have to be addressed during the next state legislative session in 2021.

State Sen. Kelly Hancock, a Republican from North Richland Hills, sponsored SB1264. He said "a rulemaking process that does not protect all patients … is not something we will be willing to accept." Hancock said the intent of the legislation was to protect every Texan with state-regulated health insurance from getting balance-billed by any provider.

"We are trusting the process, but we are also verifying the process to make sure we get the end result we are looking for," Hancock said. "And, frankly, what I think those who support the legislation voted for."

State Rep. Tom Oliverson, a Republican from Cypress who co-sponsored the bill, said he's not as concerned as others about the proposed rules. He said the waiver process included in the bill was supposed to be something that was rarely used and he thinks the board's final rules will honor that.

Oliverson, who is an anesthesiologist in Texas, said he doesn't anticipate providers will abuse the waiver system.

"It was designed to be something that was seldom used, but we are not going to let it become a pathway to avoid the law," Oliverson said. "And if it gets abused, we will come back in 2021 and get rid of it."

Hancock said it is fairly unusual for bills to go through a rulemaking process this bumpy. He said he thinks this is happening because the stakes for this process are high for many entities who may have been relying on surprise billing as a source of income.

"We have no intentions of seeing the efforts and the intentions of legislators being ignored ― just because associations want to get things their way," he said.

Pogue said this situation is particularly disheartening because it was a bipartisan effort in Texas, a rare phenomenon.

"I haven't seen a bill with a scope this big ― that could be this meaningful for the financial security of a family — pass in the 12 years I have been doing this," Pogue said.

Hutson said SB1264 was "painfully created" and lawmakers took the time to find a compromise with both insurers and providers, which is no easy task.

"There's a lot of money in health care ― and so the different interests are going to use whatever they can to collect money on the backs of consumers wherever they can, unfortunately," Hutson said. "It's frustrating."

This story is part of a partnership that includes KUT, NPR and Kaiser Health News.

Ashley Lopez, KUT: alopez@kut.org, @‪AshLopezRa‪dio

UVA Doctors Decry Aggressive Billing Practices By Their Own Hospital

KFF Health News, November 24, 2019

Docs said they had little idea how aggressively the hospital where they practice was billing and pursuing their patients for payment.

This article was first published on Saturday, November 23, 2019, in Kaiser Health News.

By Jay Hancock November 23, 2019

Prominent doctors at UVA Health System are expressing public outrage at their employer's practices to collect unpaid medical debt from its patients.

A Kaiser Health News report in September that showed UVA sued 36,000 patients over six years for more than $100 million, seizing wages and savings and even pushing families into bankruptcy.

Over six years, the state institution filed 36,000 lawsuits against patients seeking a total of more than $106 million in unpaid bills, a KHN analysis finds.

Like many physicians who work at U.S. medical centers, the UVA doctors said they had little idea how aggressively the hospital where they practice was billing and pursuing their patients for payment.

Although the health system has announced some interim measures to scale back collections practices, some of the system's most senior physicians are now calling for UVA to stop suing its patients altogether. And they are urging the pursuit of an "immediate solution" to address the national epidemic of health care debt.

"We were appalled by the revelations of the aggressive, pitiless billing and collections practices" at UVA, Dr. Scott Heysell and two other senior staff members wrote in a letter to KHN published Saturday. "We felt betrayed," they wrote, "and we had, by extension, betrayed those who had relied on us."

Heysell, an infectious-disease specialist and associate professor at UVA School of Medicine, and his co-authors echoed other UVA researchers and clinicians contacted by a reporter who said they were surprised and dismayed by the health system's practices.

UVA initially defended its practices, pointing to the Virginia Debt Collection Act of 1988, which requires state agencies to "aggressively collect" money owed. But within days of the KHN report, UVA said it would reduce its use of the courts and make it easier for patients to qualify for financial assistance.

That's not enough, said the letter's authors, who include Dr. Rebecca Dillingham, director of UVA's Center for Global Health, and Dr. Michael Williams, director of the UVA Center for Health Policy.

They ask "why UVA cannot join other public hospitals that have effectively stopped suing patients altogether?"

Other University of Virginia faculty said the system's practices undermined their efforts to improve care for middle- and lower-income families and was not in keeping with an ethos of putting patients first.

KHN's findings "made me feel utterly hypocritical about my work and efforts to promote health equity," Rajesh Balkrishnan, a UVA public health professor who researches cancer treatment in Appalachia, said in an interview.

"This is a public university with one of the richest endowments in the country," he said. "At least take care of the immediate community you serve."

In September, UVA Health said it would "reduce our reliance on the legal system," suing patients only if their household income is more than 400% of the federal poverty level, or $103,000 for a family of four. It also pledged to increase discounts for the uninsured and upgrade its financial assistance for patients.

Those measures are "a first step," it said. On Oct. 28, it named an advisory council of community leaders, patient advocates and UVA students and staff to consider further changes.

"We are continuing to thoughtfully review our billing and collection practices to find additional ways to better serve our patient as well as improve fairness and transparency," said UVA Health spokesman Eric Swensen. "We are looking at all options to achieve these goals."

Virginia Gov. Ralph Northam, who oversees the state's university system and public hospitals, is a pediatric neurologist.

"As a doctor himself, Gov. Northam agrees with the doctors who have taken a stand against unfair and aggressive medical billing practices," his spokeswoman said. "Much more can and should be done to address this issue."

KHN's report prompted discussions across the campus in Charlottesville about how to treat uninsured patients or those with coverage who still struggle with thousands of dollars in out-of-pocket expenses, doctors and faculty said.

"No physician wants to be responsible for bankrupting a patient — not one physician, not one patient," said Dr. Mohan Nadkarni, UVA's chief of general internal medicine. He is the only physician on the advisory council.

"UVA physicians were completely taken aback by the scale and magnitude of the collections practices," Nadkarni said. Discussion at the council's first meeting reflected "lots of pent-up dissatisfaction from community leaders" about UVA's practices, he said.

But many knew the health system was suing patients, they said. Some had firsthand experience with aggressive tactics from the billing office.

At one "town meeting" of health system employees, held at UVA's Leonard Sandridge Auditorium in response to KHN's report, somebody took the mic and asked, "Who in this room has been taken to collections by UVA?" said Matthew Gillikin, a speech therapist who was there. A quarter to a third of the people raised their hands, he said.

Court data analyzed by KHN showed that UVA Health was suing about 100 of its employees every year.

Also at the town meetings, "we heard many agonizing stories of patients and employees having been sued or having wages garnished," Nadkarni said. "We heard loud and clear from many physicians that they heavily supported significant liberalization" of UVA Health's financial assistance policies.

Family physician Dr. Alex Salomon, who worked at UVA for seven years and now is with Augusta Health in Fishersville, Va., had "a lot of patients" with UVA bill and lawsuit problems, many who had insurance but could not make out-of-pocket payments, he said. Still, he added, "I didn't realize UVA was so much worse" than other hospitals.

As part of the University of Virginia, UVA Health is a state institution that is not subject to taxation. UVA Medical Center, the system's flagship hospital, made a $91 million operating profit on revenue of $1.8 billion in the fiscal year ending in June and held stocks, bonds and other investments worth about $1 billion.

Doctors are realizing that financial barriers to treatment and budget squeezes from bills can be as harmful to patients as disease, said Dr. Marty Makary, a surgeon and researcher at Johns Hopkins Medicine who studies hospital debt collection and is urging UVA alumni to press for further change.

"I have not talked to a single patient or student of UVA or faculty member or alumni who thinks it is reasonable for the hospital to sue patients who cannot afford their bill," he said.

News of UVA collections practices served as a teaching moment for at least one class.

"Many of the students in my class work for the UVA Health System, so the recent media coverage about UVA's billing practices has been painful for them as nurses who care deeply about the patients and families they serve," Kimberly Acquaviva, a professor who teaches health policy at UVA's nursing school, tweeted in September. "As a class, we talked about the power that nurses have to shape the lives of the patients and families" by advocating for system change, she said.

She declined a request for an interview, as did five other doctors or professors. Several referred a reporter to UVA spokesman Swensen. About 20 others did not respond to interview requests.

Dr. Chris Ghaemmaghami, an emergency and internal medicine doctor, became UVA Health's acting CEO after Pamela Sutton-Wallace announced her resignation in September. Her departure was unrelated to KHN's revelations, UVA said at the time.

"I understand the disappointment some fellow physicians felt when our historic billing and collection practices came to light," he said in an email responding to questions from KHN.

Heysell, Williams and Dillingham, the doctors who wrote the letter, go further.

"To be clear, we are outraged," they write. "We stand with those that have been financially injured, whose bank accounts have been looted, whose homes have been swallowed as if they were built on quicksand, whose credit scores were ruined, and whose mental health and energy were spent in a courtroom or in anxious conversations with lawyers — all as a result of having sought our care."

Jay Hancock: jhancock@kff.org, @JayHancock1

No Safety Switch: How Lax Oversight Of Electronic Health Records Puts Patients At Risk

KFF Health News, November 21, 2019

Plans for putting patient safety first — and for building a comprehensive injury reporting and reviewing system — have stalled for nearly a decade.

This article was first published on Thursday, November 21, 2019 in Kaiser Health News.

By Fred Schulte and Erika Fry, Fortune

In fall 2009, several dozen of the best minds in health information technology huddled at a hotel outside Washington, D.C., to discuss potential dangers of an Obama White House plan to spend billions of tax dollars computerizing medical records.

The health data geeks trusted that transitioning from paper to electronic records would cut down on medical errors, help identify new cures for disease and give patients an easy way to track their health care histories.

But after two days of discussions, the group warned that few safeguards existed to protect the public from possible consequences of rolling out the new technology so quickly. Because this software tracks the medicines people take and their vital signs, even a tiny error or omission, or a doctor's inability to access the file quickly, can be a matter of life or death.

The experts at that September 2009 meeting, mainly members of the American Medical Informatics Association, or AMIA, agreed that safety should be a top priority as federal officials poured more than $30 billion into subsidies to wire up medical offices and hospitals nationwide.

The group envisioned creating a national databank to track reports of deaths, injuries and near misses linked to issues with the new technology.

It never happened.

Instead, plans for putting patient safety first — and for building a comprehensive injury reporting and reviewing system — have stalled for nearly a decade, because manufacturers of electronic health records (EHRs), health care providers, federal health care policy wonks, academics and Congress have either blocked the effort or fought over how to do it properly, an ongoing investigation by Fortune and Kaiser Health News shows.

Over the past 10 years, the parties have squabbled over how best to collect injury data, over who has the power to require it, over who should pay for it, and over whether to make public damning findings and the names of those responsible for safety problems.

In 2015, members of Congress derailed a long-planned EHR safety center, first by challenging the government's authority to create it and later by declining to fund it. A year later, Congress stripped the Food and Drug Administration of its power to regulate the industry or even to track malfunctions and injuries.

"A lot of people involved with patient safety and medical informatics were horrified," said Ross Koppel, a University of Pennsylvania sociologist and prominent EHR safety expert. Koppel said the industry won legal status as a "regulatory free zone" when it came to safety, an outcome he called a "scandal beyond belief."

The Electronic Health Record Association, a trade group that represents more than 30 vendors, declined to comment on the safety issue.

Meanwhile, patients remain at risk of harm. In March, Fortune and KHN revealed that thousands of injuries, deaths or near misses tied to software glitches, user errors, interoperability problems and other flaws have piled up in various government-sponsored and private repositories. One study uncovered more than 9,000 patient safety reports tied to EHR problems at three pediatric hospitals over a five-year period.

Allegations of EHR-related injuries or other flaws have surfaced in the courts. KHN/Fortune examined more than two dozen such cases, such as a California woman who mistakenly had most of her left leg amputated because the EHR sent another patient's pathology report indicating cancer to her medical file. A Vermont patient died after a doctor's order to scan her brain for an aneurysm never made it from the computer to the lab.

Despite such incidents, experts believe EHRs have made medicine safer by eliminating errors due to illegible handwriting and in some cases speeding up access to vital patient files. But they also acknowledge they have no idea how much safer, or how much the systems could still be improved because no one — a decade after the federal government all but mandated their adoption — is assessing the technology's overall safety record.

KHN and Fortune found that at least a dozen expert commissions, federal health IT panels and medical associations have echoed AMIA's early call to track EHR safety risks only to be thwarted by objections from the industry or its allies, or by simple bureaucratic inertia. Some critics see the situation as a dispiriting Washington tale of corporate "capture" of government, while others wonder why a warning system to alert health officials to dangers with certain software is even controversial.

"How is it in the public interest for medical records software to have flaws that lead to deaths?" said Joshua Sharfstein, who served as FDA deputy commissioner when the safety issue flared up during President Barack Obama's first term. These incidents "should be fully understood and investigated" and "not be able to be buried."

Support for computerizing medical records has spanned the political spectrum. The health IT industry's aversion to FDA oversight has won support at critical times both with liberals who embraced EHRs as a high-tech magic bullet for reforming the nation's costly health care system and with free-market conservatives skeptical of red tape and government interventions.

The vendors protested they were overburdened with technical requirements that their software had to meet to qualify for the government subsidy program. Those specifications included many relatively small-bore features, like including a check box indicating the doctor had asked about the patient's smoking status — and other tasks likely to have little impact on safety.

Complicating things further, many safety advocates themselves have worried that heavy-handed oversight — such as requiring approval of every software update — could actually make the technology less safe, stalling urgent software updates (not to mention stifling innovation and slowing the marketing of vital new technology).

After a contentious process in which consumer advocacy group Public Citizen accused FDA officials of collaborating with the devices industry to weaken oversight, Congress passed the 21st Century Cures Act. A few sentences buried in the law, signed by Obama in late 2016, all but shut the door on FDA regulation of EHRs.

The bipartisan law, which speeds up approvals for some medical therapies, states flatly that electronic health records are not medical devices subject to FDA scrutiny. Some longtime EHR safety advocates say they have all but given up hope for consensus on any system that would investigate and share findings from adverse events, as happens in other industries, like transportation and aviation.

"We have nothing like that," said Justin Starren, director of the Center for Data Science and Informatics at Northwestern University. "We have the opposite … with vendors saying that customers are explicitly forbidden from publicizing problems they encounter."

Starren noted that health care providers don't like to share safety failures either: "It's the liability fear. If an institution holds up its hand and says, 'Our EHR might be killing people,' the lawyers will be lining up outside the courthouse door."

Less Red Tape Unleashes Red Flags?

In the months before the 2009 AMIA meeting, concern was mounting at the FDA over the rapidly advancing EHR rollout.

Since the mid-1980s, however, the FDA had considered health IT to present a low risk of harm because a "learned intermediary," such as a doctor, was in charge. Most manufacturers agreed and insisted their products were not medical devices, but vehicles for processing and storing medical information.

The legal distinction is critical. While the FDA requires device makers to report adverse events, the policy in place gave EHR manufacturers a pass. At least one major vendor, Cerner Corp., has concluded that EHRs are, in fact, medical devices and has submitted some error reports to FDA's public MAUDE database. But most manufacturers disagree and have not reported data, leaving a sizable gap in the agency's grasp of possible hazards.

Within the FDA, some staffers urged the agency to rethink the hands-off stance given the rush by hundreds of health IT companies — many of them new entrants — to sell medical records software that tens of thousands of doctors, hospitals and patients would rely on.

On Sept. 22, 2009, FDA staff shared their views with deputy commissioner Sharfstein and his boss, commissioner Margaret Hamburg, at a "regulatory strategy" meeting. After hearing the pitch, Hamburg agreed the FDA "needs to be involved in the White House [EHR] initiative," according to an agency memo. Hamburg had no comment for this article.

One former FDA official recalls tension mounting as the agency became more assertive, saying: "It was a big train going down the tracks at 80 miles per hour, and there were concerns that FDA would slow it down."

The FDA sounded a public warning at a February 2010 hearing. The agency's chief devices regulator, Jeffrey Shuren, testified that even with limited surveillance, the FDA had tied six deaths and 44 reported injuries to health information technology failures.

In all, Shuren said, the FDA had logged 260 reports of "malfunctions with the potential for patient harm" over the previous two years. In one case, the software filed results from emergency lab tests to the wrong patient's electronic record.

Shuren described the reports as likely the "tip of the iceberg" and said they suggested "significant clinical implications and public safety issues." He laid out three options for FDA involvement, the least burdensome being registration of EHR software and mandatory reporting of dangerous incidents. Through an agency spokesperson, Shuren declined to be interviewed for this article.

Shuren's 2010 testimony did not appear to carry much weight with David Blumenthal, a Harvard physician chosen as the Obama administration's point man for the digital medical record rollout. Blumenthal declined to comment.

Many in Blumenthal's division, known as the Office of the National Coordinator for Health Information Technology, or ONC, sympathized with the industry's assertion that FDA regulation would discourage innovation, which, in turn, could cripple the president's plans to revolutionize health care and save money. Blumenthal, who was convinced EHRs would make medicine much safer, described the FDA injury reports as "anecdotal."

An obscure outpost of the Department of Health and Human Services in the second Bush administration, ONC under Blumenthal revved up as federal officials laid plans for distributing billions of stimulus dollars.

The stimulus law directed ONC to set up two diverse advisory panels so that no single faction of the health care sector could unduly influence policy. Yet it seemed clear, at least to skeptics, that ONC depended heavily on the goodwill, expertise and guidance of the technology community.

Steven Findlay, who served on one of the panels as a representative of Consumers Union, said industry witnesses often "commandeered" the discussions because they "had the technical knowledge to steer things in a direction that they wanted."

Safety "was not necessarily their first priority. They were building products to serve an industry and designing them to make money," Findlay said in a recent interview.

Dean Sittig, a medical informaticist at the University of Texas Health Science Center at Houston and early researcher on EHR safety, said ONC was "trying to promote" digital records "and there wasn't a lot of interest in talking about things that could go wrong." That conflict persists, he said. "They gave out $36 billion. It's hard for them to say EHRs aren't safe."

The ONC did form a safety "working group." The panel suggested that doctors and hospitals be required to report "potential hazards" and "incidents" to a national database or risk forfeiting government subsidies for purchasing records software, according to minutes from its March 12, 2010, meeting.

That idea never got past the drafting stage, however.

Glitches In The Matrix

In a nod to safety, ONC asked the National Academy of Sciences' Institute of Medicine to weigh in, a move some at the FDA hoped would at the least lend support for nationwide collection of injury data.

When the 18-member expert panel held a public hearing in mid-December 2010, Shuren reappeared with updated FDA figures — about 370 reports of "adverse events or near misses" involving health IT since January 2008. Once again, he called FDA's count a "small percentage of the actual [adverse] events that do occur."

Among the causes he cited: failure of the software to interface properly with other technologies, user errors, design flaws and inadequate pre-market testing.

Shuren suggested EHRs were medical devices over which the FDA "has exercised enforcement discretion; meaning it has not enforced existing requirements," an apparent reference to the hands-off policy. He called for "real-time collection, aggregation and analysis" of reports on the functioning of EHRs.

The Institute of Medicine panel in November 2011 called on HHS to make adverse incident reporting mandatory for vendors and voluntary for users. It also said HHS should ask Congress to approve a government-run injury monitoring system as rigorous as that used to promote airline safety that would both investigate and make its findings public. The FDA might not be the best-equipped agency to take on the task, the group noted.

The panel asserted that EHR vendors face "competing priorities, including maximizing profits and maintaining a competitive edge, which can limit shared learning and have adverse consequences for patient safety."

One member called for even stricter oversight. In an impassioned dissent, Richard Cook, a Chicago radiologist and safety expert, argued EHRs were medical devices that necessitated the scrutiny of the FDA.

"At least a few U.S. citizens — perhaps more than a few — have died or have been maimed because of health IT. The extent of the injuries generated by health IT is unknown because no one has bothered to look for them in a systematic fashion," Cook wrote in his dissent.

Backtracking On Oversight

In 2012, Congress required FDA, ONC and the Federal Communications Commission to propose "risk-based" oversight for health IT that "promotes innovation, protects patient safety, and avoids regulatory duplication."

Two years went by before the agencies did so. In April 2014, they promoted a "limited, narrowly tailored approach" to oversight led by the ONC as well as a "surveillance mechanism" to track adverse events and near misses.

ONC's budget for the 2015 and 2016 fiscal years proposed spending $5 million for such a center, which ONC said would begin "a robust collection and analysis of health IT-related adverse events."

But four House Republicans in June 2014 questioned whether ONC had the legal authority to set up the center.

Energy and Commerce Committee Chairman Fred Upton of Michigan, Vice Chairman Marsha Blackburn of Tennessee, health subcommittee Chairman Joseph Pitts of Pennsylvania and communications and technology subcommittee Chairman Greg Walden of Oregon argued that ONC had failed to satisfy their concerns over what Blackburn termed regulatory "mission creep." At a House hearing in July 2014, Blackburn repeated her worry about "a misguided system of regulation."

Former ONC director Karen DeSalvo said she was five months on the job and felt completely blindsided by the line of questioning — despite the National Academy of Sciences report years earlier that had advised HHS to seek approval from Congress to expand ONC's oversight role. The center's prospects dimmed further when the Congressional Research Service issued a report on the matter in early 2015 that seemed to side with the Republicans.

DeSalvo's team later requested legislative authority to create the center, but the effort was not successful. ONC was granted legislative authority for other requests, however, empowering it to define interoperability and to crack down on vendors who improperly restrict access to medical records.

These days, many of the key players have conflicting opinions and recollections about what went wrong and why.

DeSalvo, now a professor of medicine and population health at Dell Medical School, said she really doesn't know if something sinister torpedoed the safety center or it was just a matter of not enough people caring. "It was really just kind of start and stop," she said. That's perhaps not surprising, considering ONC has had seven directors in its 15 years of existence — and six since 2009, when the government made EHRs a national priority. (And that's not counting four interim directors who collectively helmed the outfit for 16 months.)

Doug Fridsma, who left his role as ONC's chief scientist in 2014, cited other factors that slowed the center's momentum. He said uncertainty over its mission didn't help gain the trust of the industry, while citing other thorny issues, such as who would foot the bill and whether its data might be used to discipline or otherwise harm vendors. Fridsma, now AMIA's chief executive, said that government-sponsored regional patient safety organizations aren't well equipped to conduct national oversight of EHR functions.

"It has resulted in a vacuum around health IT safety," said Fridsma. "Congress has failed to make it a priority."

Shifting Public Attention

Revisiting plans for a full-fledged EHR safety center holds little appeal to Don Rucker, the Trump administration's ONC chief.

Rucker said he sees little value in collecting data on incidents often "years and years" after they occurred. Rapidly evolving technologies are making computer errors easier to recognize and remedy. "We can catch these things a lot earlier," he said.

Rucker argues that the 21st Century Cures Act prohibits the industry from enforcing "gag" clauses that in the past have handcuffed hospitals and doctors from criticizing their EHRs. The Cures law includes fines of up to $1 million for "information blocking," including taking steps to discourage EHR users from reporting adverse events and other problems for review.

New freedom to sound off assures that doctors and hospitals will begin sharing EHR problems, mitigating any need for mandatory reporting, in Rucker's view. Rucker said he hopes to have the regulations in place by the end of the year.

The proposed ONC regulations cite a "strong public interest" in "open communication of information regarding health hazards, adverse events and unsafe conditions." But that information won't be shared with the public. ONC says all reports of problems are exempt from public release under the Freedom of Information Act. Congress gave these records the same legal status as income tax returns as part of the Cures law.

Jacob Reider, a former ONC interim director, said the government's failure to do more to promote public awareness of safety concerns is disappointing — and even irresponsible — given its zeal in bringing EHRs into the mainstream of medicine.

"I remember internal conversations where we talked about 'What is the equivalent of a plane crash that is going to get the attention of people?'" said Reider, who now practices family medicine in upstate New York. "'Is it going to be a congressperson's relative is harmed by health IT that causes the attention to shift?' I would offer that still hasn't happened yet, but someday it will. And gosh, wouldn't it be a horrible thing that we have to wait for that to happen?"

Fred Schulte: fschulte@kff.org, @fredschulte

The Case Of The ACA's Disappearing Taxes

KFF Health News, November 20, 2019

The past decade has shown that it's been relatively easy to make hard-won tax increases go away, suggesting that health-related interest groups, still wield a lot of power on Capitol Hill.

This article was first published on Wednesday, November 20, 2019 in Kaiser Health News.

By Julie Rovner

It was a moment of genuine bipartisanship at the House Ways and Means Committee in October, as Democratic and Republican sponsors alike praised a bill called the "Restoring Access to Medication Act of 2019."

The bill, approved by the panel on a voice vote, would allow consumers to use their tax-free flexible spending accounts or health savings accounts to pay for over-the-counter medications and women's menstrual products.

Assuming it ultimately finds its way into law, the measure would also represent the latest piece of the Affordable Care Act's financing to be undone.

Over-the-counter medication had been eligible for preferred tax status before the ACA. But that treatment was eliminated as part of a long list of new taxes and other provisions to generate revenue. The measures were aimed primarily at higher-income earners to pay the 10-year, roughly $1 trillion cost of the health law.

"It is paid for. It is fiscally responsible," said President Barack Obama as he signed the ACA into law in 2010.

But not so much anymore. Many of those "pay-fors," particularly the taxes, "have been eliminated, delayed or are in jeopardy," said Marc Goldwein of the Committee for a Responsible Federal Budget, a nonpartisan budget watchdog group. "All this stuff, it turns out, is very unpopular," he said.

The first piece of financing to disappear happened before most of the law even took effect. Congress in 2011 repealed a requirement that small businesses report to the IRS any payment of more than $600 to a vendor. The idea was that if more payments were reported to taxing authorities, more taxes due would actually get paid. Small businesses complained — loudly — that the new paperwork requirement would be excessive and Congress (and Obama) eventually agreed. The change eliminated an estimated $17 billion in ACA financing over 10 years.

In 2015, Congress delayed (for the first time) the so-called Cadillac tax, a 40% tax on the most generous employer health plans that was intended to curb excessive use of medical services. Business, labor and patient advocacy groups banded together in a coalition called the Alliance to Fight the 40, and they got Congress to delay its implementation from 2018 to 2020. In 2018, Congress delayed it again, to 2022. This past summer, the House voted overwhelmingly to eliminate the tax, which had been estimated to raise nearly $200 billion over the next decade.

Also on ice, thanks to that 2018 bill, are levies that were supposed to be paid by medical device makers and health insurance companies, originally worth a combined $80 billion in financing during the law's first decade.

Yet another — albeit fairly small — source of financing for the law went away in the GOP tax bill in 2017, which zeroed out the tax penalty for failing to have health insurance. The penalty raised $4 billion in 2018, the last year it was in effect.

Still, the two ACA taxes that generate the most revenue are on the books and collecting money. They are aimed at people with high incomes (more than $200,000 for individuals and $250,000 for couples) and were estimated to bring in more than $200 billion from 2010 to 2019. The measures, which don't deal directly with services or provisions of the ACA, raise Medicare taxes for people at those higher incomes and increase taxes on unearned income.

The durability of these two taxes does not surprise Goldwein. Some are "unpopular to repeal," he said, like "a tax on the rich that funds Medicare."

What Goldwein does find surprising, though, is how durable some of the ACA's reductions in spending have been. The health law, somewhat controversially, reduced Medicare payments to hospitals, insurance companies and a broad array of other health providers.

"The Medicare cuts have been for the most part surprisingly sustainable politically," he said. Even when the GOP took over the House in 2011, their budget maintained the reductions from the ACA. So did the 2017 GOP "repeal and replace" proposal.

On the other hand, the appointed board of experts that was to rein in future Medicare spending, the "Independent Payment Advisory Board," never got off the ground. Congress formally repealed it in 2018.

So what does this all mean? The Congressional Budget Office is no longer estimating the individual budget effect of how the ACA was paid for. But the past decade has shown that it's been relatively easy to make hard-won tax increases go away, suggesting that interest groups, particularly health-related interest groups, still wield a lot of power on Capitol Hill.

That means that going forward, candidates' promises about new benefits financed by new taxes should be viewed with some skepticism, said Goldwein.

Even as presidential candidates on the campaign trail are issuing financing plans, on Capitol Hill "right now everyone wants to cancel a 3% tax on the health insurance industry," Goldwein said. That's a reference to a major advertising campaign underway by an industry coalition of small business and insurance groups called "Stop the HIT." The tax is one of those delayed in 2018 that will resume if Congress does not delay it again or repeal it.

Given that, he said, how likely is it that Congress — even one controlled by Democrats — would really "cancel the whole industry" by passing a "Medicare for All" bill?

Julie Rovner: jrovner@kff.org, @jrovner

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