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Ambulance Company Pays $65,000 to Settle Allegations of Longstanding HIPAA Noncompliance

HHS Gov News - December 30, 2019

West Georgia Ambulance, Inc. (West Georgia), has agreed to pay $65,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and to adopt a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Security Rule. West Georgia is an ambulance company that provides emergency and non-emergency ambulance services in Carroll County, Georgia.

OCR began its investigation after West Georgia filed a breach report in 2013 concerning the loss of an unencrypted laptop containing the protected health information (PHI) of 500 individuals. OCR’s investigation uncovered long-standing noncompliance with the HIPAA Rules, including failures to conduct a risk analysis, provide a security awareness and training program, and implement HIPAA Security Rule policies and procedures. Despite OCR’s investigation and technical assistance, West Georgia did not take meaningful steps to address their systemic failures.

“The last thing patients being wheeled into the back of an ambulance should have to worry about is the privacy and security of their medical information,” said OCR Director Roger Severino. “All providers, large and small, need to take their HIPAA obligations seriously.”

In addition to the monetary settlement, West Georgia will undertake a corrective action plan that includes two years of monitoring. The resolution agreement and corrective action plan may be found at https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/westgeorgia/index.html.

A Reality Check On Artificial Intelligence: Are Health Care Claims Overblown?

Health products powered by artificial intelligence, or AI, are streaming into our lives, from virtual doctor apps to wearable sensors and drugstore chatbots.

IBM boasted that its AI could “outthink cancer.” Others say computer systems that read X-rays will make radiologists obsolete.

“There’s nothing that I’ve seen in my 30-plus years studying medicine that could be as impactful and transformative” as AI, said Dr. Eric Topol, a cardiologist and executive vice president of Scripps Research in La Jolla, Calif. AI can help doctors interpret MRIs of the heart, CT scans of the head and photographs of the back of the eye, and could potentially take over many mundane medical chores, freeing doctors to spend more time talking to patients, Topol said.

Even the Food and Drug Administration ― which has approved more than 40 AI products in the past five years ― says “the potential of digital health is nothing short of revolutionary.”

Yet many health industry experts fear AI-based products won’t be able to match the hype. Many doctors and consumer advocates fear that the tech industry, which lives by the mantra “fail fast and fix it later,” is putting patients at risk ― and that regulators aren’t doing enough to keep consumers safe.

Early experiments in AI provide a reason for caution, said Mildred Cho, a professor of pediatrics at Stanford’s Center for Biomedical Ethics.

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Systems developed in one hospital often flop when deployed in a different facility, Cho said. Software used in the care of millions of Americans has been shown to discriminate against minorities. And AI systems sometimes learn to make predictions based on factors that have less to do with disease than the brand of MRI machine used, the time a blood test is taken or whether a patient was visited by a chaplain. In one case, AI software incorrectly concluded that people with pneumonia were less likely to die if they had asthma ― an error that could have led doctors to deprive asthma patients of the extra care they need.

“It’s only a matter of time before something like this leads to a serious health problem,” said Dr. Steven Nissen, chairman of cardiology at the Cleveland Clinic.

Medical AI, which pulled in $1.6 billion in venture capital funding in the third quarter alone, is “nearly at the peak of inflated expectations,” concluded a July report from the research company Gartner. “As the reality gets tested, there will likely be a rough slide into the trough of disillusionment.”

That reality check could come in the form of disappointing results when AI products are ushered into the real world. Even Topol, the author of “Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again,” acknowledges that many AI products are little more than hot air. “It’s a mixed bag,” he said.

(Lynne Shallcross/KHN Illustration; Getty Images)

Experts such as Dr. Bob Kocher, a partner at the venture capital firm Venrock, are blunter. “Most AI products have little evidence to support them,” Kocher said. Some risks won’t become apparent until an AI system has been used by large numbers of patients. “We’re going to keep discovering a whole bunch of risks and unintended consequences of using AI on medical data,” Kocher said.

None of the AI products sold in the U.S. have been tested in randomized clinical trials, the strongest source of medical evidence, Topol said. The first and only randomized trial of an AI system ― which found that colonoscopy with computer-aided diagnosis found more small polyps than standard colonoscopy ― was published online in October.

Few tech startups publish their research in peer-reviewed journals, which allow other scientists to scrutinize their work, according to a January article in the European Journal of Clinical Investigation. Such “stealth research” ― described only in press releases or promotional events ― often overstates a company’s accomplishments.

And although software developers may boast about the accuracy of their AI devices, experts note that AI models are mostly tested on computers, not in hospitals or other medical facilities. Using unproven software “may make patients into unwitting guinea pigs,” said Dr. Ron Li, medical informatics director for AI clinical integration at Stanford Health Care.

AI systems that learn to recognize patterns in data are often described as “black boxes” because even their developers don’t know how they have reached their conclusions. Given that AI is so new ― and many of its risks unknown ― the field needs careful oversight, said Pilar Ossorio, a professor of law and bioethics at the University of Wisconsin-Madison.

Yet the majority of AI devices don’t require FDA approval.

“None of the companies that I have invested in are covered by the FDA regulations,” Kocher said.

Legislation passed by Congress in 2016 ― and championed by the tech industry ― exempts many types of medical software from federal review, including certain fitness apps, electronic health records and tools that help doctors make medical decisions.

There’s been little research on whether the 320,000 medical apps now in use actually improve health, according to a report on AI published Dec. 17 by the National Academy of Medicine.

If failing fast means a whole bunch of people will die, I don’t think we want to fail fast. Nobody is going to be happy, including investors, if people die or are severely hurt.

Oren Etzioni, chief executive officer at the Allen Institute for AI in Seattle

“Almost none of the [AI] stuff marketed to patients really works,” said Dr. Ezekiel Emanuel, professor of medical ethics and health policy in the Perelman School of Medicine at the University of Pennsylvania.

The FDA has long focused its attention on devices that pose the greatest threat to patients. And consumer advocates acknowledge that some devices ― such as ones that help people count their daily steps ― need less scrutiny than ones that diagnose or treat disease.

Some software developers don’t bother to apply for FDA clearance or authorization, even when legally required, according to a 2018 study in Annals of Internal Medicine.

Industry analysts say that AI developers have little interest in conducting expensive and time-consuming trials. “It’s not the main concern of these firms to submit themselves to rigorous evaluation that would be published in a peer-reviewed journal,” said Joachim Roski, a principal at Booz Allen Hamilton, a technology consulting firm, and co-author of the National Academy’s report. “That’s not how the U.S. economy works.”

But Oren Etzioni, chief executive officer at the Allen Institute for AI in Seattle, said AI developers have a financial incentive to make sure their medical products are safe.

“If failing fast means a whole bunch of people will die, I don’t think we want to fail fast,” Etzioni said. “Nobody is going to be happy, including investors, if people die or are severely hurt.”

Relaxing Standards At The FDA

The FDA has come under fire in recent years for allowing the sale of dangerous medical devices, which have been linked by the International Consortium of Investigative Journalists to 80,000 deaths and 1.7 million injuries over the past decade.

Many of these devices were cleared for use through a controversial process called the 510(k) pathway, which allows companies to market “moderate-risk” products with no clinical testing as long as they’re deemed similar to existing devices.

In 2011, a committee of the National Academy of Medicine concluded the 510(k) process is so fundamentally flawed that the FDA should throw it out and start over.

Instead, the FDA is using the process to greenlight AI devices.

The FDA, headquartered just outside Washington, D.C., has long focused its attention on devices that pose the greatest threat to patients.(Al Drago/CQ Roll Call via AP Images)

Of the 14 AI products authorized by the FDA in 2017 and 2018, 11 were cleared through the 510(k) process, according to a November article in JAMA. None of these appear to have had new clinical testing, the study said. The FDA cleared an AI device designed to help diagnose liver and lung cancer in 2018 based on its similarity to imaging software approved 20 years earlier. That software had itself been cleared because it was deemed “substantially equivalent” to products marketed before 1976.

AI products cleared by the FDA today are largely “locked,” so that their calculations and results will not change after they enter the market, said Bakul Patel, director for digital health at the FDA’s Center for Devices and Radiological Health. The FDA has not yet authorized “unlocked” AI devices, whose results could vary from month to month in ways that developers cannot predict.

To deal with the flood of AI products, the FDA is testing a radically different approach to digital device regulation, focusing on evaluating companies, not products.

The FDA’s pilot “pre-certification” program, launched in 2017, is designed to “reduce the time and cost of market entry for software developers,” imposing the “least burdensome” system possible. FDA officials say they want to keep pace with AI software developers, who update their products much more frequently than makers of traditional devices, such as X-ray machines.

Scott Gottlieb said in 2017 while he was FDA commissioner that government regulators need to make sure its approach to innovative products “is efficient and that it fosters, not impedes, innovation.”

Under the plan, the FDA would pre-certify companies that “demonstrate a culture of quality and organizational excellence,” which would allow them to provide less upfront data about devices.

Pre-certified companies could then release devices with a “streamlined” review ― or no FDA review at all. Once products are on the market, companies will be responsible for monitoring their own products’ safety and reporting back to the FDA. Nine companies have been selected for the pilot: Apple, FitBit, Samsung, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Tidepool and Verily Life Sciences.

High-risk products, such as software used in pacemakers, will still get a comprehensive FDA evaluation. “We definitely don’t want patients to be hurt,” said Patel, who noted that devices cleared through pre-certification can be recalled if needed. “There are a lot of guardrails still in place.”

But research shows that even low- and moderate-risk devices have been recalled due to serious risks to patients, said Diana Zuckerman, president of the National Center for Health Research. “People could be harmed because something wasn’t required to be proven accurate or safe before it is widely used.”

Johnson & Johnson, for example, has recalled hip implants and surgical mesh.

In a series of letters to the FDA, the American Medical Association and others have questioned the wisdom of allowing companies to monitor their own performance and product safety.

“The honor system is not a regulatory regime,” said Dr. Jesse Ehrenfeld, who chairs the physician group’s board of trustees.

In an October letter to the FDA, Sens. Elizabeth Warren (D-Mass.), Tina Smith (D-Minn.) and Patty Murray (D-Wash.) questioned the agency’s ability to ensure company safety reports are “accurate, timely and based on all available information.”

Scott Gottlieb said in 2017 while he was FDA commissioner that government regulators need to make sure its approach to innovative products “is efficient and that it fosters, not impedes, innovation.”(Francis Ying/KHN)

When Good Algorithms Go Bad

Some AI devices are more carefully tested than others.

An AI-powered screening tool for diabetic eye disease was studied in 900 patients at 10 primary care offices before being approved in 2018. The manufacturer, IDx Technologies, worked with the FDA for eight years to get the product right, said Dr. Michael Abramoff, the company’s founder and executive chairman.

The test, sold as IDx-DR, screens patients for diabetic retinopathy, a leading cause of blindness, and refers high-risk patients to eye specialists, who make a definitive diagnosis.

IDx-DR is the first “autonomous” AI product ― one that can make a screening decision without a doctor. The company is now installing it in primary care clinics and grocery stores, where it can be operated by employees with a high school diploma. Abramoff’s company has taken the unusual step of buying liability insurance to cover any patient injuries.

Yet some AI-based innovations intended to improve care have had the opposite effect.

A Canadian company, for example, developed AI software to predict a person’s risk of Alzheimer’s based on their speech. Predictions were more accurate for some patients than others. “Difficulty finding the right word may be due to unfamiliarity with English, rather than to cognitive impairment,” said co-author Frank Rudzicz, an associate professor of computer science at the University of Toronto.

Doctors at New York’s Mount Sinai Hospital hoped AI could help them use chest X-rays to predict which patients were at high risk of pneumonia. Although the system made accurate predictions from X-rays shot at Mount Sinai, the technology flopped when tested on images taken at other hospitals. Eventually, researchers realized the computer had merely learned to tell the difference between that hospital’s portable chest X-rays ― taken at a patient’s bedside ― with those taken in the radiology department. Doctors tend to use portable chest X-rays for patients too sick to leave their room, so it’s not surprising that these patients had a greater risk of lung infection.

While it is the job of entrepreneurs to think big and take risks, it is the job of doctors to protect their patients.

Dr. Vikas Saini, a cardiologist and president of the nonprofit Lown Institute, which advocates for wider access to health care

DeepMind, a company owned by Google, has created an AI-based mobile app that can predict which hospitalized patients will develop acute kidney failure up to 48 hours in advance. A blog post on the DeepMind website described the system, used at a London hospital, as a “game changer.” But the AI system also produced two false alarms for every correct result, according to a July study in Nature. That may explain why patients’ kidney function didn’t improve, said Dr. Saurabh Jha, associate professor of radiology at the Hospital of the University of Pennsylvania. Any benefit from early detection of serious kidney problems may have been diluted by a high rate of “overdiagnosis,” in which the AI system flagged borderline kidney issues that didn’t need treatment, Jha said. Google had no comment in response to Jha’s conclusions.

False positives can harm patients by prompting doctors to order unnecessary tests or withhold recommended treatments, Jha said. For example, a doctor worried about a patient’s kidneys might stop prescribing ibuprofen ― a generally safe pain reliever that poses a small risk to kidney function ― in favor of an opioid, which carries a serious risk of addiction.

As these studies show, software with impressive results in a computer lab can founder when tested in real time, Stanford’s Cho said. That’s because diseases are more complex ― and the health care system far more dysfunctional ― than many computer scientists anticipate.

Many AI developers cull electronic health records because they hold huge amounts of detailed data, Cho said. But those developers often aren’t aware that they’re building atop a deeply broken system. Electronic health records were developed for billing, not patient care, and are filled with mistakes or missing data.

A KHN investigation published in March found sometimes life-threatening errors in patients’ medication lists, lab tests and allergies.

In view of the risks involved, doctors need to step in to protect their patients’ interests, said Dr. Vikas Saini, a cardiologist and president of the nonprofit Lown Institute, which advocates for wider access to health care.

“While it is the job of entrepreneurs to think big and take risks,” Saini said, “it is the job of doctors to protect their patients.”

Hospital Group Mum As Members Pursue Patients With Lawsuits And Debt Collectors

The American Hospital Association, the biggest hospital trade group, says it promotes “best practices” among medical systems to treat patients more effectively and improve community health.

But the powerful association has stayed largely silent about hospitals suing thousands of patients for overdue bills, seizing homes or wages and even forcing families into bankruptcy.

Atlantic Health System, whose CEO is the AHA’s chairman, Brian Gragnolati, has sued patients for unpaid bills thousands of times this year, court records show, including a family struggling to pay bills for three children with cystic fibrosis.

AHA, which represents nearly 5,000, mostly nonprofit hospitals and medical systems, has issued few guidelines on such aggressive practices or the limited financial assistance policies that often trigger them.

In a year when multiple health systems have come under fire for suing patients, from giants UVA Health System and VCU Health to community hospitals in Oklahoma, it has made no concrete move to develop an industry standard.

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“There could be a broader message coming out of hospital leadership” about harsh collections, said Erin Fuse Brown, a law professor at Georgia State University who studies hospital billing. “It seems unconscionable if they are claiming to serve the community and then saddling patients with these financial obligations that are ruinous.”

Nonprofit hospitals are required to provide “community benefit,” including charity care in return for billions of dollars in government subsidies they get through tax exemptions. But the rules are lax and vague, experts say, especially for bill forgiveness and collections.

The Affordable Care Act requires nonprofit hospitals to have a financial assistance policy for needy patients but offers no guidance about its terms.

“There is no requirement” for minimum hospital charity under federal law, said Ge Bai a health policy professor at Johns Hopkins. “You design your own policy. And you can make it extremely hard to qualify.”

Practices vary sharply, a review of hospital policies and data from IRS filings show. Some hospitals write off the entire bill for a patient from a family of four making up to $77,000 a year. Others give free care only if that family makes less than $26,000.

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The law does not substantially limit harsh collections, either. IRS regulations require only that nonprofit hospitals make “reasonable efforts” to determine if patients qualify for financial assistance before suing them, garnishing their wages and putting liens on their homes.

Gaping differences in both collections and financial assistance show up in the policies of health systems represented on AHA’s board of trustees.

This year, AHA board chairman Gragnolati’s Atlantic Health System, in northern New Jersey, sued patients for unpaid bills more than 8,000 times, court records show.

Atlantic Health sued Robert and Tricia Mechan of Maywood, N.J., to recover $7,982 in unpaid bills for treatment of their son Jonathan at the system’s Morristown Medical Center.

Three of the Mechans’ four children have cystic fibrosis, a chronic lung disease, including Jonathan, 18. Tricia Mechan works two jobs — full time as a manager at Gary’s Wine & Marketplace and part time at Lowe’s — to try to pay doctor and hospital bills that pile up even with insurance.

“I have bill collectors call me all the time,” Tricia Mechan said. “You’re asking me for more, and all I’m doing is trying to get the best care for my children. I didn’t ask to have sick children.”

She closed a savings account and borrowed money to settle Jonathan’s bill for $6,000. Another son with cystic fibrosis, Matthew, owes Atlantic Health $4,200 and is paying it off at $25 a month, she said.

Marna Borgstrom, CEO of Yale New Haven Health, also sits on AHA’s board. Yale almost never sues families like the Mechans.

“I have not signed off on a legal action since 2015” against a patient, Patrick McCabe, the system’s senior vice president of finance, said in an interview. “People are coming to us when they are at their most vulnerable, and we truly believe we need to work with them and not create any additional stress that can be avoided.”

Yale has treated Nicholas Ruschmeyer, 30, a Vermont ski mountain manager, for recurring cancer. He has been careful to maintain insurance, but a few years ago the hospital performed a $12,000 genetic test that wasn’t covered.

“Yale completely absorbed the cost,” said his mother, Sherrie Ruschmeyer. Yale is “wonderful to work with, not at all aggressive,” she said.

Atlantic Health bars families from receiving financial assistance if they have more than $15,000 in savings or other assets. Yale never asks about savings. Even families who own homes without a mortgage qualify if their income is low enough.

Atlantic Health’s policies including seizing patient wages and bank accounts through court orders to recoup overdue bills. Yale says it does not do this.

In some ways, Atlantic Health’s policies are more generous than those of other systems.

It forgives bills exceeding 30% of a family’s income in many cases, the kind of “catastrophic” assistance some hospitals lack. It also bills many uninsured patients only slightly more than Medicare rates. That’s far less than rates charged by other hospitals in the same situation that are substantially higher than the cost of treatment.

“Atlantic Health System’s billing policy complies with all state and federal guidelines,” said spokesman Luke Margolis. “While we are willing to assist patients no matter their financial situation, those who can pay should do so.”

After a reporter inquired about its practices, Atlantic Health said it “is actively engaged in refining our policies to reflect our patients’ realities.”

AHA also is considering changing its position on billing in the wake of recent reports on aggressive and ruinous hospital practices.

Previously AHA said billing offices should “assist patients who cannot pay,” without giving specifics, and treat them with “dignity and respect.” Queried this month, association CEO Rick Pollack said, “We are reevaluating the guidelines [for collections and financial assistance] to ensure they best serve the needs of patients.”

Kaiser Health News found that the University of Virginia Health System sued patients 36,000 times over six years, taking tax refunds, wages and property and billing the uninsured at rates far higher than the cost of care. Richmond-based VCU Health’s physicians group sued patients 56,000 times over seven years, KHN also found.

In Memphis, Methodist Le Bonheur Healthcare sued patients for unpaid bills more than 8,000 times over five years, ProPublica reported. In South Carolina, hospitals have been taking millions in tax refunds from patients and their families, an examination by The Post and Courier showed.

In response, VCU pledged to stop suing all patients. UVA promised to “drastically” reduce lawsuits, increase financial assistance and consider further steps. Methodist erased debt for 6,500 patients and said it would overhaul its collections rules.

Yale’s less aggressive policies also came in response to journalism — a 2003 Wall Street Journal report on how the system hounded one family. Yale still sends overdue bills to collections, McCabe said. But it balks at the last, drastic step of asking a court to approve seizing income and assets.

For patients with unpaid bills, he said, “if you’re willing to play a game of chicken, you will win.”

Hospitals say they see more and more patients who can’t pay, even with insurance, as medical costs rise, family incomes plateau and out-of-pocket health expenses increase. In particular, they blame widespread high-deductible coverage, which requires patients to pay thousands before the insurance takes over.

“More consumers pay far more with fewer benefits,” Pollack said.

Some states go beyond federal rules for charity care and collections. In California, patients with an income of less than $90,000 for a family of four must be eligible for free or discounted care. New Jersey requires Atlantic Health and other systems to give free care to patients from families of four with income less than $51,000.

The National Consumer Law Center, a nonprofit advocacy group, suggests all states adopt that standard for large medical facilities. Its model medical debt law also would require substantial discounts for families of four with income below $103,000 and relief for patients with even higher incomes facing catastrophic bills.

The AHA should consider similar changes in its own guidelines, NCLC attorney Jenifer Bosco said.

“I would be interested in seeing them taking a more active role in creating some standard for hospitals about what’s too much,” she said. “What’s going too far? Given that this is a helping profession, what would be some appropriate industry standards?”

KHN senior correspondent Jordan Rau contributed to this report.

Coping With Loss Of Hospital, Rural Town Realizes: We Don’t Need A Hospital

Eliza Oliver helps her daughter, Taelyn, step down from the exam table after her wellness check at Community Health Center. The child’s doctor, who worked at the now-closed hospital, has been given a medical scribe who takes notes. The visit this time seemed more “personal,” Oliver says.(Sarah Jane Tribble/KHN)

This story also ran on NPR. This story can be republished for free (details). FORT SCOTT, Kan. ― Dr. Max Self grabbed a sanitary wipe and cleaned off the small flashlight in his hands. More than 20 years as a family doctor in rural Fort Scott, Kan., has taught him a few tricks: “I’ve got my flashlight. See? Look, you want to hold it?”

Read More From Our 'No Mercy' Series

Exploring what happens when the closure of one beloved rural hospital disrupts a community’s health care, economy and equilibrium. Read KHN’s year-long series, No Mercy.

Two-year-old Taelyn’s brown eyes grow round and her tiny hand reaches out. But, first, Self makes sure she opens her mouth wide and he peers down. Behind him sits another staff member ― a medical scribe. Self’s scribe gives him the ability to “focus on people,” rather than toggling between a computer screen and the patient. It’s a new perk he didn’t have when he worked at Mercy Hospital.

That beloved hospital closed one year ago and, in the passing months, the small town’s anger and fear evolved into grief, nervousness and ― lately ― pragmatic hope. Most of the handful of physicians in town stayed, taking jobs at a regional federally qualified health care center that took over much of the clinic work from Mercy. The emergency department, after closing for 18 days, was reopened temporarily ― run by a hospital 30 miles south.

It’s not “all gloom and doom, although we all wish we had a hospital ― no doubt about it,” insurance agent Don Doherty said during the town’s weekly Chamber of Commerce coffee on Dec. 12.

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Nationwide, death rates have been higher in rural America compared with urban areas since the 1980s, and the gap continues to widen. More rural residents live with chronic conditions, like diabetes, that affect their daily lives, and there is a higher percentage of older residents. Rates of smoking and premature births are relatively high, and people often die younger here than the national average.

Since 2010, 120 rural hospitals have closed across the country ― 19 in this year alone, according to data from the University of North Carolina’s Cecil G. Sheps Center for Health Services Research. A national analysis of Medicare cost reports found that 21% of the nation’s remaining rural hospitals are at high risk of closing.

“Frankly, it’s not getting better,” said Dr. Daniel DeBehnke, study co-author and a managing director with Navigant’s health care practice.

A year ago, after Mercy gave a 90-day notice that it would close, City Manager Dave Martin said the betrayal felt by city leaders led to lawyers and calls with other health care systems about taking over the facility. Now, Martin has realized “we will not have ― or do we need ― a hospital.”

But, if not a hospital to care for rural communities like Fort Scott with its 7,800 residents, what is needed? The answers to that question play out every day here and could hold lessons for the rest of the country.

For months after Mercy Fort Scott Hospital closed, patients couldn’t get appointments with Dr. Max Self quickly. “I don’t like to hear that,” Self says. His new employer, Community Health Center of Southeast Kansas, assigned him a medical scribe, who does his computer work. Now, Self says, he can see more patients.(Sarah Jane Tribble/KHN)

‘You Will Be Taken Care Of’

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Self has cared for his share of struggling patients in this town, where 1 in 4 children live in poverty, and its main corridor ― U.S. 69 ― is lined with fast-food restaurants. But Fort Scott is “not far off” from what it needs to be healthy. Sure, residents have to travel south 30 miles to Pittsburg, Kan., or north 90 miles to the Kansas City, Kan., area to be hospitalized, but “you will be taken care of,” he said.

Self’s new employer is Community Health Center of Southeast Kansas, which as a federally qualified health center gets a higher level of government reimbursement for Medicare and Medicaid patients than Mercy did, said Jason Wesco, executive vice president at CHC.

The center can also gain grants to take care of the uninsured, which is important in states like Kansas that did not expand Medicaid, though Wesco said it has not received any for Fort Scott.

Wesco estimates 90-95% of the health care offered before the hospital closed is still available locally. And services have been added, including a much-needed therapist on-site for behavioral health and telehealth access to a psychiatrist and substance abuse services.

“Drive up there, go into the parking lot, you’re like ‘There’s a lot of people here,’” Wesco said. CHC’s Fort Scott facilities have filled more prescriptions and done more mammograms in a month than the hospital “ever did,” he said.

Jason Wesco, executive vice president of Community Health Center, says he believes “the best people in the world” are from southeastern Kansas, where the federally qualified health center he helps run is based. Since the center took over clinics in Fort Scott, Wesco says, the primary care services they provide can “lift up this place. … We can fix it, we just need time.” (Sarah Jane Tribble/KHN)

Community Health Center’s Fort Scott facilities have filled more prescriptions and done more mammograms in a month than the hospital “ever did,” Wesco says.(Sarah Jane Tribble/KHN)

Local residents like 28-year-old Eliza Oliver, whose daughter, Taelyn, easily passed her annual wellness check with Dr. Self, said it’s much less expensive to get care and prescriptions at the new health center. That part is great, Oliver said, but she still worries about the future of emergency care in town and where people can deliver babies.

Another Catholic hospital chain, Ascension Via Christi, which has a facility 30 miles away in Pittsburg, Kan., stepped in at the last minute to operate Mercy’s old emergency room, signing a two-year agreement. This was vital: While much of the rest of Mercy Hospital Fort Scott had been underused and patient rooms sat empty, the ER handled nearly 9,000 people the year before it closed.

Mercy Hospital delivered more than 230 babies between July 2017 and June 2018. A few months ago ― after the hospital closed ― Oliver drove a friend who was in labor across the Missouri border more than 20 miles to deliver. “We had to jet over there and even though we made it in time, it’s nerve-wracking,” Oliver said.

Another Catholic hospital chain, Ascension Via Christi, stepped in at the last minute to operate Mercy’s old emergency room, signing a two-year agreement.(Sarah Jane Tribble/KHN)

Not having a community hospital does require a new mindset. The community still has an obstetrician, but doctors send patients out of town to have their babies. By June this year, Ascension’s Fort Scott ER staff had delivered three babies for expectant mothers who didn’t leave enough time.

Randy Cason, president at Ascension’s Pittsburg hospital, drove to Fort Scott to tell the weekly chamber coffee that doctors needed to “counsel and educate” mothers that it’s no longer a 10-minute drive to the hospital.

Sherise Beckham, a former Mercy dietitian, was anxious on bed rest this spring while awaiting a baby. “You’re on a two-lane highway; a lot of times you get behind a semi, behind a tractor,” Beckham laughed. “Sometimes, you are lucky if you have cell service.”

Beckham’s delivery did not go as planned. After driving to Ascension’s Pittsburg hospital to meet her family doctor, she had an unexpected cesarean section, and the baby, whose heart rate dropped dramatically, was transferred to a neonatal intensive care unit an hour away from home in Joplin, Mo. Now, eight months later, the baby is healthy though he continues to see a physical therapist who monitors his developmental progress.

Dietitian Sherise Beckham cooks dinner with her family — husband Tanner, 8-month-old Barrett and 2-year-old Warren.(Sarah Jane Tribble/KHN)

Recent research by Katy Backes Kozhimannil, an associate professor at the University of Minnesota School of Public Health found that rural residents have a 9% greater chance of dying or suffering complications such as heart failure, stroke and the need for blood transfusions during childbirth compared with non-rural residents.

Federal policymakers have said they want to do better. President Donald Trump’s administration this year set new Medicare payment policies that included more telehealth services and changed some payments for rural hospitals. Seema Verma, the administrator for the Centers for Medicare & Medicaid Services, also promised a new rural health payment model and “a lot of people are waiting with bated breath,” said George Pink, a senior research fellow at UNC’s Sheps Center.

CMS declined to comment on the timing of the proposal.

Congress, too, has made overtures to passing legislation. Maggie Elehwany, lead federal lobbyist for the National Rural Health Association, said the Affordable Care Act’s promise that hospitals would have more insured patients and less bad debt “never really unfolded in rural America.” The 14 states that have not adopted Medicaid expansion are largely rural and many are in the South, where the greatest number of hospitals have closed.

Sisters of Mercy nuns founded the Fort Scott hospital in 1886. A mantra etched in stone over the entrance of one old Mercy hospital building read: “Dedicated to suffering humanity.”(Sarah Jane Tribble/KHN)

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As Fort Scott deals with the trauma of losing a beloved institution, deeper national questions underlie the struggle: Do small, rural communities need a traditional hospital at all? And if not, how will they get the health care they need?

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Catholic nuns founded the Fort Scott hospital more than a century ago and 89-year-old Fred Campbell still recalls a mantra etched in stone over the entrance of one old Mercy hospital building: “Dedicated to suffering humanity.”

“We always felt that, man, come hell or high water, you’re gonna be with us and you’re not going to abandon us,” Campbell said.

But exactly a year ago, its then-owner, St. Louis-based Mercy, a major health care conglomerate with more than 40 hospitals, declared it no longer financially viable.

Within weeks of Mercy closing, a newly built $9 million grocery store closed. A few weeks later, the cancer center closed and, by October, the town’s dialysis center had closed, too. John Leatherman, professor for the department of agricultural economics at Kansas State University, said there’s no doubt Bourbon County took “a big hit” when the hospital was shuttered.

Roxine Poznich lost her income when her job at Mercy ended. After more than 20 years at the hospital, the 73-year-old said she now finds herself paying for groceries with her credit card ― even though she is unsure whether she can pay the bill at the end of the month. “I’m scared,” Poznich said.

Roxine Poznich, owner of Books & Grannies in Fort Scott, Kan., was a 27-year employee of Mercy Hospital in Fort Scott. She lost her job when the hospital closed and now manages her bookstore full time.(Christopher Smith for KHN)

But Fort Scott economic development director Rachel Pruitt said the loss of the hospital has not affected the city’s sales tax revenue. Manufacturers like the community’s largest employer, Peerless Architectural Windows and Doors, with its 400 jobs, continue to expand ― just down the road from where Mercy’s 177,000-square-foot hospital building still stands.

City leaders say ideally the community would “right-size” its health care. That would include keeping the current outpatient clinics that provide primary care and an emergency department but also adding some inpatient beds, allowing residents with short-term hospitalization to stay local. Pruitt said there has even been talk of adding a wound center that could treat injuries among the town’s industrial workers.

And, though the mostly empty Mercy Hospital building feels like a white elephant, that too may soon change: Mercy recently announced it would donate land in a repurposed corner of its property to Community Health Center. Health center leaders have hired an architect for a new building that will probably be about 30,000 square feet. Wellness, imaging, walk-in care, a women’s health center, dental care and expanded primary and specialty care would be available.

Fort Scott City Manager Dave Martin says he knows the town will never have another full-service hospital, and it doesn’t need one. Instead, Martin and his staff believe they need “right-sized” health care. (Christopher Smith for KHN)

Reta Baker was the president of Mercy Hospital Fort Scott when it closed. She has since sold her house and moved closer to her new job at CHC headquarters in Pittsburg, Kan.(Sarah Jane Tribble/KHN)

ER operator Ascension declined requests for interviews, but spokeswoman Michelle Kennedy said the Pittsburg leadership team is “working on plans related to our presence in Fort Scott in the near future” but could not release details. City leaders say they are confident an ER will remain.

In the background, there is Reta Baker. Residents here denounced the former president of Mercy Hospital Fort Scott at the time of the closure. She sold her house and moved closer to her new job with CHC, at its headquarters in Pittsburg, Kan.

Baker, who started her career as a nurse at Fort Scott’s hospital in 1981 and grew up nearby, said she continues to “be engaged in a lot of conversations” about the community’s future. The next year will have growing pains, she said, but she believes the health care needed for residents is there.

“Now, we need to cement it,” she said.

This is the fifth installment in KHN’s year-long series, No Mercy, which follows how the closure of one beloved rural hospital disrupts a community’s health care, economy and equilibrium. Coming in 2020, a podcast from KHN with more voices and stories from Fort Scott, Kansas.

Reports Of Patients’ Deaths Linked To Heart Devices Lurk Below Radar

The Food and Drug Administration continues to file thousands of reports of patients’ deaths related to medical devices through a reporting system that keeps the safety data out of the public eye.

The system is similar to a vast program exposed earlier this year by KHN that kept device-injury reports effectively hidden within the agency. The FDA shuttered the program after the article about it was published and released millions of records.

Hidden Harm Read More

The result of this remaining so-called registry exemption program is that key death data about heart devices sits in inaccessible FDA reports that can take up to two years for the public to see under open-records laws. Device-related death reports are typically open, allowing researchers to track and alert their peers about safety concerns.

The FDA carved out the exemption in 2010 and it covers six devices, a spokeswoman said. Doctors tend to report extensive data on patients for certain medical devices that are closely monitored in registries. Private medical societies tend to administer the registries and act as gatekeepers to the data.

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The registry leaders, in turn, have reported data to device makers, who sent the FDA spreadsheets detailing what they know about more than 8,000 patient deaths. Those spreadsheets are also inaccessible to the public.

Under standard FDA reporting rules, the device maker is bound to investigate and send the agency a detailed public report about each patient death believed to be device-related.

Device makers say the registries strip key data they need to fully investigate each death, most of them related to heart valves threaded through a catheter and implanted in faulty hearts.

“It’s crazy,” said Diana Zuckerman, president of the National Center for Health Research. “I have to say, there’s not a particular reason I can think of why you put [summary reports] behind some kind of firewall where no one can see it.”

An FDA spokeswoman said the agency just got additional funding from Congress that it plans to use to make “more information readily available and easier to access.”

“We agree that the public should have access to more information about reports of adverse events for medical devices,” the agency said in an email, noting that its current public device database called MAUDE is outdated and “has limited functionalities.”

Earlier this year, the FDA shut down other so-called exemptions to its device-reporting rules that put millions of device harm or malfunction reports out of public reach. Doctors, researchers and even device-safety experts were unaware that for 20 years the FDA accepted 5.7 million reports through its “alternative summary reporting” program.

The FDA released the data ― and the identity of 108 devices that had been quietly “exempted” from public reporting ― in June after KHN reported on the scope of the program.

The FDA also said in December that it is no longer accepting “litigation” summary reports, also highlighted in the KHN report, which makers of pelvic mesh and surgical robots used to file thousands of reports on spreadsheets straight to the agency.

The FDA said it left the registry exemption in place to support the massive datasets being built around certain devices. The registry data helps the agency “act quickly with manufacturers and health care professionals to make more timely, evidence-based decisions to mitigate device problems and keep patients safe,” the statement said.

The FDA accepts hundreds of death reports on spreadsheets kept within the agency from the TVT Registry, which tracks valves threaded through a patient’s vessel in a catheter and implanted in the heart.

The devices have been hailed as lifesaving for patients too fragile for open-heart surgery. They have also been controversial because they have created a need in some patients for an additional device ― a pacemaker ― compounding their risk. Experts have also questioned whether the devices will be durable, particularly as they’re increasingly implanted in younger patients.

Such a heart valve made by Medtronic called CoreValve amassed the most reports, with more than 5,800 death incidents reported since 2014, according to Medtronic. The device was initially approved for patients too sick for open-heart surgery.

The device helped boost survival in fragile, elderly heart patients, with nearly three-quarters still alive and free of major strokes a year after the valve was implanted. It and a competing, similar valve have since been approved for use in younger, healthier patients.

The quarterly summary reports filed with the FDA note hundreds of deaths and thousands of injuries. They say the “anonymized” registry data did not have enough information for Medtronic to determine whether the event was previously reported to the company or the FDA’s public device-injury database called MAUDE. The spreadsheet sent straight to the FDA includes “observations related to patient deaths.”

Medtronic filed far fewer stand-alone public device-death reports, about 900, many summarizing valve-related deaths mentioned in published research. While device companies are required to report patient deaths to the FDA if they have enough information to investigate, doctors are not ― explaining some of the reporting gap.

Medtronic said in a statement that it strives to eliminate malfunctions in all of its devices, but, when they occur, “we make every effort to inform regulators, the healthcare community and the public in a timely … manner.” The company said about 40% of deaths reported from the registry data list no cause, so it’s unclear if they were related to the device.

The maker of the competing device approved in 2011, the Sapien 3 Transcatheter valve, also files death reports under the registry exemption. Edwards Lifesciences filed spreadsheets since 2016 reflecting 2,400 death incidents and individual reports on about 400 deaths.

Edwards’ reports describe possible device-related deaths in patients who had too little or too much calcification in their hearts or whose deaths were attributed to fragility and age. Edwards also notes in its summary filings that “device information is not included in the data received from the registry.”

Edwards spokeswoman Sarah Huoh said that 600,000 patients worldwide have benefited from transcatheter valve surgery. She noted that the Sapien 3 valve used in healthier, younger patients showed a “remarkably low” 1% death or disabling stroke rate a year after surgery. 

Dr. Steven Nissen, chief academic officer at the Cleveland Clinic, said the number of deaths is not alarming, given the frailty of the patients initially undergoing the procedures. But he said the underlying data sent to the FDA should be open.

“To understand safety of devices, we need to have access to all of the data,” he said.

The valve business is brisk and growing, with much of the money coming from the taxpayer-funded Medicare program. Edwards reported $700 million in sales for one quarter of this year for its Sapien valves and predicts a $7 billion market in 2024.

In all, the FDA said it has granted registry exemptions to six devices tracked in three registries. Makers of the MitraClip, which is also threaded in a catheter to clip together flaps in the heart, have filed spreadsheets reflecting more than 500 deaths.

The FDA said it has also given the registry exemption for a cardiac device called the Watchman and to Medtronic’s Valiant Thoracic Stent Graft and a Medtronic catheter used to reopen blocked leg arteries.

Electronic Health Records Creating A ‘New Era’ Of Health Care Fraud

The federal government funneled billions in subsidies to software vendors who overstated or deceived the government about what their products could do, according to whistleblowers.(Lydia Zuraw/KHN)

This story also ran on Fortune. This story can be republished for free (details). Derek Lewis was working as an electronic health records specialist for the nation’s largest hospital chain when he heard about software defects that might even “kill a patient.”

The doctors at Midwest (City) Regional Medical Center in Oklahoma worried that the software failed to track some drug prescriptions or dosages properly, posing a “huge safety concern,” Lewis said. Lewis cited the alleged safety hazards in a whistleblower lawsuit that he and another former employee of Community Health Systems (CHS) filed against the Tennessee-based hospital chain in 2018.

The suit alleges that the company, which had $14 billion in annual revenue in 2018, obtained millions of dollars in federal subsidies fraudulently by covering up dangerous flaws in these systems at the Oklahoma hospital and more than 120 others it owned or operated at the time.

The whistleblowers also allege that Medhost, the Tennessee firm that developed the software, concealed defects during government-mandated reviews that were supposed to ensure safety.

Both CHS and Medhost have denied the allegations and moved to dismiss the suit. The motions are pending. Last month, Department of Justice lawyers wrote in court filings that they were still investigating the matter and had not yet decided whether to take over the case.

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The lawsuit is one of dozens filed by whistleblowers, doctors and hospitals alleging that some electronic health records (EHR) software used in hospitals and medical offices has hidden flaws that may pose a danger to patients — and that a substantial chunk of the $38 billion in federal subsidies went to companies that deceived the government about the quality of their products, an ongoing Fortune-KHN investigation shows. The subsidies were designed to persuade hospitals and doctors’ offices to install software that would track the medical history of every patient and share the information seamlessly with other health care providers.

But the software makers allegedly gamed the system, repeatedly. Three major EHR vendors have made multimillion-dollar settlement deals — totaling $357 million — over Justice Department investigations which include allegations that they rigged or otherwise gamed the government’s certification test. At least two other companies are under investigation.

Beyond those cases, federal officials have paid hundreds of millions of dollars in subsidies to doctors and hospitals that could not show they were even qualified to receive them, according to federal officials. Nearly 28% of doctors and 5% of hospitals who attested to meeting government standards later failed audits. Federal officials told Fortune and KHN that they have clawed back $941 million in improper subsidies.

“We’re entering an entirely new area of health care fraud,” John O’Brien, senior counsel with the Department of Health and Human Services Office of Inspector General, said in a July 2017 video announcing a $155 million False Claims Act settlement with eClinicalWorks, one of the nation’s leading sellers of EHRs for physicians.

The concern is not just over wasteful spending of tax dollars. EHRs monitor the medicines people take and their vital signs, so software glitches that prevent doctors from accessing files quickly, that mix up patients or send vital test results to the wrong file can contribute to serious injuries, or even deaths.

In March, Fortune and KHN revealed that thousands of injuries, deaths or near misses tied to software defects, user errors and other problems have piled up in various government-sponsored and private repositories.

“Ultimately, it’s about patients getting the right care,” Andrew Vanlandingham, the HHS inspector general’s senior counselor for health information technology, said in an interview. He said that investigators are “gearing up” for more scrutiny of the important industry, including closer monitoring to make sure that records software is safe.

The Justice Department accused eClinicalWorks, an EHR company whose medical software is used by 130,000 providers, of rigging the government’s certification test, claims the company has denied. eCW settled the case for $155 million in 2017.

Leaping Into The Digital Era

In 2009, Congress committed billions of dollars in economic stimulus funds to bring the era of paper medical records to a close. Officials hoped to cut down on medical errors caused by illegible paper records and draw on the power of massive troves of medical data to drive down the cost of health care and help develop improved treatments for disease.

The hastily devised plan offered Medicare doctors and other medical professionals up to $44,000 and $64,000 in subsidies if they bought the software and accepted patients on Medicaid, the federal health care program for low-income people.

The money was intended to help them pay vendors to install EHRs in their offices. Hospitals, which required more sophisticated and costlier software, could receive millions in subsidies, based on the number of inpatients treated. To give them a nudge, officials warned doctors and hospitals that failure to wire up would trigger gradual cuts in their Medicare payments. EHR vendors had to meet certification standards set by the HHS Office of the National Coordinator for Health Information Technology, or ONC.

Providers had to attest that their EHR software could perform a variety of functions, which the government described as making “meaningful use” of the technology.

Certification was essentially an open-book test in which the government gave vendors the questions in advance — for instance, the names of 16 or so drugs the system would have to prescribe electronically to pass. The Justice Department has alleged that some vendors simply doctored their software to pass the test — for example, programming the required codes for just the specified 16 drugs they would be tested on, rather than all medicines — as officials had expected.

Frank Poggio who recently retired from a 45-year career in health technology, saw the cases of fraud coming, he said, because the tests “were superficial, and if you wanted to game it, you could game it.”

Poggio said there were many weaknesses in the system that allowed a vendor to show a “prototype” as opposed to live software.

Dr. Scott Monteith, a Michigan psychiatrist who served as an early certification juror, said he saw some limitations firsthand. He said one vendor took 30 minutes to produce a list of patients who had diabetes and also smoked, data he figured any computer program should be able to spit out in seconds. The vendor passed.

“That’s an example of how poorly thought-out the whole thing was,” said Monteith, who noted he was then, and still is, a big booster of EHRs.

Jeffery Daigrepont, a senior vice president at Coker Group, a firm that advises health providers on business decisions, said the government erred by handing out too much money in the early stages of the program, when many doctors and hospitals had not yet done much more than agree to participate.

“It was an upside-down pyramid,” he said. “You got the bulk of the money for doing the least amount of effort.”

Dr. John Halamka, a physician and Harvard Medical School professor who chaired the ONC standards committee, which wrote the certification rules, defended the process.

“The only problem [with certification] is that it presupposed that the product the vendor certified would be the same product they sold,” Halamka said. “It presupposes that people will go into the certification process and participate in good faith.”

That did not always happen in the rush to snatch up subsidy dollars, according to the whistleblowers’ suits. The Justice Department case against eClinicalWorks, which has 130,000 providers, accused the company of rigging tests to win certification, claims the company has denied. The company did not respond to numerous requests for comment.

The government accused Greenway Health, a Florida-based EHR developer with 75,000 providers, of doing the same thing. The DOJ’s complaint included a number of instant-message exchanges between Greenway employees in which they allegedly discuss their plan for gaming the certification process by “shortcutting some functionality” of the software. In February, Greenway Health settled with the government for just over $57 million without admitting wrongdoing.

The whistleblower case filed by Lewis and former co-worker Joey Neiman accuses the CHS hospital chain of submitting more than $385 million in false claims for EHR stimulus payments between 2012 and 2014.

The government accused Greenway Health, a Florida-based electronic health records company, of gaming the government’s certification process. In 2019, the company settled those allegations for $57.25 million without admitting wrongdoing.

Visiting the Oklahoma hospital as part of a troubleshooting team in June 2015, Lewis heard that physicians worried flaws in the system could result in patients being sent home “with the wrong drugs, doses or instructions,” according to the suit.

Things got so bad that local doctors were threatening to admit patients elsewhere unless the hospital fixed the software problems, according to the suit.

In a statement, CHS said it had “complete confidence” in its records systems. “The allegations made in the lawsuit against our hospitals are completely without merit,” the company said. Medhost denied its software has flaws, noting in its statement: “Hundreds of facilities have successfully used our software over the years and continue to do so today.”

Few in the industry seemed surprised by such allegations. When news of the eClinicalWorks case broke, Farzad Mostashari, who led the ONC from 2011 to 2013, tweeted: “Let me be plain-spoken. eClinicalWorks is not the only EHR vendor who ‘flouted certification/misled’ customers. Other vendors better clean up.”

The Electronic Health Record Association, a trade group that represents more than 30 vendors, did not respond to a request for comment. However, vendors have argued that they faced a tangle of regulations that required them to meet constantly shifting standards that government officials often could not explain.

ONC officials declined to answer written questions. But in a statement, ONC said it takes steps to ensure that products “are safe for patients and usable by providers.”

System Glitches And Accusations Of ‘Gaming’ The System

While the ONC sets the standards, the federal Centers for Medicare & Medicaid Services (CMS) had the job of paying doctors and hospitals that attested to meeting the “meaningful use” criteria. As of September 2018, CMS had paid out $38.4 billion in these funds.

In 2012, CMS hired accounting firm Figliozzi and Co. of Garden City, N.Y., which audited almost 50,000 medical professionals. Nearly 28% failed, despite the fact that they had previously attested to meeting the standards. Hospitals did better, posting a 5% failure rate. CMS officials said they have recovered some $941 million in these improper payments. The losses to the Treasury are likely far higher because only 14% of the medical professionals and 40% of the hospitals receiving payments were audited.

(Lydia Zuraw/KHN)

Michael Arrigo, who has served as an expert witness in health IT-related fraud and medical malpractice cases, said that in some cases EHR vendors misled hospitals about the challenges of replacing paper records with computers.

Others rolled the dice, apparently hoping the program was so large and complicated that they were unlikely to be targeted for audit. “Sometimes [providers] got away with it until a whistleblower found out,” Arrigo said.

Reviewing state and federal court filings, Fortune and KHN found more than two dozen cases, many filed by hospitals against vendors, which depict chaotic EHR installations and safety concerns as they pursued meaningful-use dollars.

Parrish Medical Center, a 210-bed public hospital on Florida’s Space Coast, is one. In December 2010, the Titusville hospital contracted with McKesson’s Enterprise Information Solutions. One of America’s largest companies, McKesson said its product would be easy for doctors and nurses to learn and help them “deliver high-quality, safe patient care.”

But the deal collapsed, prompting a bitter court battle in which the hospital repeatedly assailed McKesson’s competence. For instance, the hospital alleged that bugs in the software caused it to create more than one record for the same patient, a flaw dubbed a “major safety issue.”

An expert hired by Parrish said he contacted eight other hospitals, including three in Florida, which had dumped McKesson due to what he called “poor or unsatisfactory customer service.”

The medical staff at one of those hospitals was “up in arms” because it took 63 mouse clicks to look up a patient’s lab results, according to the expert’s report.

Parrish later signed on with another EHR vendor and the suit has since been settled. Both Parrish and McKesson declined to comment for this story. McKesson sold its health IT business to Allscripts in October 2017. Earlier this year, Allscripts reported to the Securities and Exchange Commission that government attorneys have requested documents from the company as part of an investigation into McKesson’s certification.

In another lawsuit, Weirton Medical Center, a hospital in West Virginia, stated in a court filing that it submitted “inaccurate” meaningful-use data to the government ― though it blamed the vendor. The hospital alleged the system failed to identify a patient who was critically ill and in the hospital. The hospital declined to comment to KHN and Fortune about the case, which has been settled.

Hamstrung By Technology?

ONC officials said they keep no log of complaints they receive.

A study published in JAMA this month found that 40% of the software that ONC singled out for post-marketing review had flaws that could lead to patient harm, including inaccurate drug codes, information displaying incorrectly and decimal points gone missing.

That’s “a concerning number, and we have to do something to address that,” said researcher Raj Ratwani, the director of the MedStar Health National Center for Human Factors in Healthcare and a co-author of the study. These systems were used in 786 hospitals and by 37,365 provider organizations, according to Ratwani, who said there’s no way to know how many defects have been fixed.

ONC has “decertified” about 100 pieces of once-approved software products. But most were tiny market players that had few or no users and went out of business. PlatinumMD, which had just 48 “meaningful” users, is an example. In a 2014 whistleblower lawsuit, San Diego urologist Dr. Scott Brown alleged that PlatinumMD filed for $18,000 in subsidies on his behalf even though it had not yet fully installed his EHR. In February 2016, the defunct company’s owners settled the case without admitting liability by paying the government $180,000.

Another 132 government-certified products have been flagged for corrective action due to “non-conformities.” As for the technology that the government alleges was fraudulently certified, it’s still used in health care settings across the country.

While those vendors faced multimillion-dollar settlements and now must operate under the oversight of a government monitor, their technology was not taken off the market. Nor were they dumped by many customers who, for the most part, however dissatisfied, were stuck with it.

ONC seemed to acknowledge that decertifying a large vendor would cause a major disruption, noting in an October 2016 regulation: “Our first and foremost desire would be to work with developers to address any problems.”

In the regulations, ONC cited the costs medical providers would face should their EHR vendor shut down as ranging from $33,000 to as much as $650 million.

“It is very difficult to switch product,” said Steve Waldren, chief medical informatics officer for the American Academy of Family Physicians. “You couldn’t just go down the street and pick up another EHR, put it in and move your data over.”

He noted that beyond the considerable cost of the technology, providers would have to take time to learn a new system.

“ONC does seem to have a stance that removing some of these players from the market would be very disruptive,” said Brad Ulrich, a Tennessee health IT expert. “They are almost too big to fail.”

Texas Law Highlights Dilemma Over Care For Patients With No Hope Of Survival

FORT WORTH, Texas ― Critically ill Tinslee Lewis ― a Fort Worth baby embroiled in a dispute between her family and a hospital over whether to continue life-sustaining treatment ― is the most recent public face of the heartbreaking and intractable dilemmas often confronted quietly in intensive care units. But her circumstances are complicated by a rare law that Texas enacted two decades ago, which critics say gives hospitals the upper hand on whether to stop treatment.

Just 15 to 20 years ago, disputes between doctors and families over the futility of further medical care flared once or twice each year, said Dr. Robert Truog, a pediatric intensive care physician at Boston Children’s Hospital. But these conflicts have become increasingly common to the point that “it’s actually rare for us not to have a patient or two in this situation in the ICU,” he said.

“Many ICUs are paralyzed by dilemmas where families are demanding continued intensive care for patients with no hope of survival beyond the intensive care unit or with a quality of life that is not acceptable even to the patient,” said Truog, who also directs Harvard Medical School’s Center for Bioethics. “And we lack a pathway for being able to refuse these demands from families without prolonged court battles that have an uncertain outcome.”

While some physician groups prefer to talk about “potentially inappropriate” rather than futile care, the underlying quandary remains. What’s the definition of “inappropriate,” who can make that determination and how best to strike a balance between family members — if the patient is typically too ill or injured to weigh in — and the doctors and nurses who can become distressed providing care indefinitely without seeing any benefit?

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The physicians treating Tinslee at Cook Children’s Medical Center in Fort Worth describe her condition as fatal without life-sustaining treatment and say that even routine care, like bathing and feeding, “can cause her little body to experience a medical crisis, which causes even more intervention and pain for her,” according to a hospital statement. The 10-month-old girl was born prematurely with a rare heart defect and other complications. In July, she was put on an extracorporeal membrane oxygenation (ECMO) machine to function in the place of her heart and lungs.

Under the Texas Advance Directives Act, when hospitals like Cook Children’s decide treatment is futile, they must see if another hospital will accept the patient. If none does, they can stop treatment after 10 days. As of Dec. 4, the hospital reported that they had unsuccessfully approached more than 20 hospitals and children’s heart specialists.

Tinslee’s mother, with financial legal support from the Texas Right to Life organization, has been seeking delays under the Texas law, as well as more broadly getting the law declared unconstitutional on due process grounds. The judge said that she would extend the temporary restraining order against the hospital until Jan. 2, according to a Texas Right to Life spokeswoman.

In the meantime, 16 state lawmakers sent a letter to Gov. Greg Abbott on Thursday urging him to call an emergency session of the legislature to consider changing the law. That prompted a letter from the Texas Hospital Association and the Catholic Health Association of Texas, which represents Catholic hospitals in the state, to the governor detailing some of the steps taken in Tinslee’s case and supporting the law. “We stand by the medical team’s efforts to lessen her pain and the ultimate recommendation to end her ongoing suffering,” wrote Stephen Wohleb, senior vice president and general counsel for the hospital association.

Contacted this month, a family member described the baby as conscious and responding to lullabies and television. The 10-day transfer deadline “literally puts an expiration date on human life,” said Tye Brown, who was referred by Texas Right to Life and identified herself as a cousin of the baby’s mother, Trinity.

Texas is one of several states, including California and Virginia, that have enacted laws enabling doctors to withdraw life-sustaining treatment even if family members disagree, said Thaddeus Pope, who directs the Health Law Institute at Mitchell Hamline School of Law in St. Paul, Minn. These laws don’t have a reporting requirement, so it’s unknown how often the legal process is pursued, he said.

The Texas law, which passed in 1999, initially was a compromise brokered between medical professionals and pro-life groups to establish a process through which a patient could be transferred elsewhere if the treating physician refused to provide further life-sustaining treatment. But in recent years the law has become more controversial, with Texas Right to Life pushing for its repeal, saying it violates due process.

While Pope supports a legal mechanism to resolve these conflicts over when care becomes futile, he argues that the Texas law should be amended because it concedes too much power to hospitals and clinicians. One problem is that the hospital serves as the judge in these disputes, and yet they are also one of the key players, he said.

Texas Attorney General Ken Paxton made a similar argument in an amicus brief in Tinslee’s case.

Among Pope’s other critiques: The act states that an ethics or medical committee shall review the medical inappropriateness decision but does little to specify the composition of the members. Also under the law, an outside judge can’t do more than extend the 10-day window for the family to find another hospital.

The law’s structure “is the worst that you can possibly design it from a fairness or due process perspective,” Pope said. “You are giving the hospital absolute, complete discretion to do whatever they want.”

Defining ‘Futility’

Researchers have attempted to capture how often clinicians perceive medical care as futile. In one California study, doctors described the treatment they provided for 11% of their ICU patients as futile, and probably futile for an additional 8.6%. Among the reasons they gave: the burdens of the treatment grossly outweighed the benefits or the patient was unable to live outside the ICU, according to the findings, published in 2013 in JAMA Internal Medicine.

Generally, physicians concur when life-sustaining treatment shouldn’t be continued, said Dr. Neil Wenger, an author of the 2013 study who also chairs the ethics committee at the UCLA Medical Center in Los Angeles. “What they disagree on is how much effort should be placed in overriding a family,” he said.

Doctors don’t want to be thrust into an adversarial role with patients and family members whom they’re striving to help, Wenger said. Plus, negotiating the ethics committee and other processes can be difficult, he said. “It’s an enormous effort.”

At the same time, these heart-wrenching cases can cause doctors, nurses and other clinicians significant distress to provide care they feel is not only inappropriate, but also may cause patient suffering, said Mary Faith Marshall, who directs the Center for Health Humanities and Ethics at the University of Virginia School of Medicine. “Health care clinicians are not robots and they’re not automatons,” she said. “And they have professional ethics requirements not to harm their patients.”

The cost of critical care treatment plays little role in these conflicts, said Marshall, a former critical care nurse. Clinicians “at the bedside generally don’t know and they don’t care what the patient’s payer source is,” she said. When asked if Tinslee has insurance coverage, a Cook Children’s spokeswoman said that she didn’t know and such information wouldn’t be publicly released.

In 2018, the Virginia legislature passed some changes to its existing statute, allowing life-sustaining care to be withdrawn if determined to be “medically or ethically inappropriate” and the patient couldn’t be transferred to another hospital within 14 days. (The Virginia law, unlike in Texas, does allow an outside judge to weigh in on the hospital’s determination, Pope noted.)

Resolving Intractable Conflicts

More such end-of-life conflicts will likely occur, said Pope, citing in part a shift in end-of-life views. In 1990, 15% of Americans agreed that doctors should do everything possible in all circumstances to save a patient’s life, according to Pew Research Center data. By 2013, the most recent data available, 31% of Americans expressed that desire.

Meanwhile, medicine has advanced to the point “that we can keep almost anybody alive in the ICU at this point,” Truog said. “And I mean that quite literally because we can take over heart and lung function, kidney function, everything. It’s very difficult to die in the ICU if we don’t let you.”

Still, better protections for the family should be part of any legal mechanism, including the option for a review by an outside judge, Truog said. A hospital ethics committee also is not the appropriate decision-maker, he added. Not only are the members typically employed by or aligned with the hospital, but they also may not have the same educational, socioeconomic or racial/ethnic background as those impacted.

To better level the playing field, a regional committee of independent experts could instead play that decision-making role, Truog suggested.

As technology advances, there needs to be some type of mechanism so physicians don’t flinch from starting treatments in high-risk cases, Wenger said. Take the patient who has suffered a massive heart attack and it’s unknown when he arrives in the emergency room how long his brain has been deprived of oxygen, he said.

With an ECMO machine, a physician can support the patient’s heart and lungs until brain activity is assessed. If the results are dismal, Wenger said, continuing the ECMO would be medically inappropriate. “You need the ability then to stop that ECMO, so you are not perpetuating the dying process.”

Paying It Forward: ‘Bill Of The Month’ Series, A Vital Toolkit For Patients, Wraps Year 2

Use Our Content This story can be republished for free (details). Send Us Your Medical Bill

Do you have an exorbitant or baffling medical bill? Join the KHN and NPR ‘Bill of the Month’ Club and tell us about your experience. We’ll feature a new one each month.

Submit Your Bill

In 2018, KHN and NPR launched “Bill of the Month,” a crowdsourced investigation in which we dissect, investigate and explain medical bills you send us. In telling the story behind one patient’s bill each month, our goal is to understand the genesis of the often exorbitant and baffling charges that pervade the American medical system.

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This year, we’ve delved into patients’ predicaments from pricey treatments for cat bites and snakebites, to the crippling costs of medical gear ($882 for a knee brace) and high-priced high tech (a $540,842 bill for dialysis, $4,836 for laughing gas during childbirth).

The lessons learned each month help “pay it forward” ― arming future health system pilgrims with the tools they need to avoid surprises or fight back against unfair charges. KHN assembled a user-friendly toolkit to help patients understand some of the ins and outs of medical billing, what to do if you receive a surprise medical bill and things to keep in mind before getting medical care.

Choosing from thousands of reader submissions, we examine each case at khn.org, in print and on NPR’s “Morning Edition” or “All Things Considered,” where you can hear the voices of the patients affected. You can also catch segments on “CBS This Morning.”

Take a spin through our coverage and consider sharing your own medical-billing horror stories. Here’s to a wiser, healthier and wealthier – with more money staying in patients’ pockets ⁠— new year for all our readers.

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Government-Funded Day Care Helps Keep Seniors Out Of Nursing Homes And Hospitals

Kaiser Health News:Medicaid - December 23, 2019

SAN MARCOS, Calif. — Two mornings a week, a van arrives at the Escondido, Calif., home of Mario Perez and takes him to a new senior center in this northern San Diego County town, where he eats a hot lunch, plays cards and gets physical therapy to help restore the balance he lost after breaking both legs in a fall.

If he wants, he can shower, get his hair cut or have his teeth cleaned. Those twice-weekly visits are the highlights of the week for Perez, a 65-year-old retired mechanic who has diabetes and is legally blind.

“The people here are very human, very nice,” he said. “I’m gonna’ ask for three days a week.”

The nonprofit Gary and Mary West PACE center, which opened in September, is California’s newest addition to a system of care for frail and infirm seniors known as the Program of All-Inclusive Care for the Elderly.

The services provided by PACE, a national program primarily funded by Medicaid and Medicare, are intended to keep people 55 and older who need nursing home levels of care at home as long as possible and out of the hospital.

The program is more important than ever as baby boomers age, its proponents say.

“The rapidly growing senior population in California and across the country will put enormous strain on our current fragmented, and often inefficient, health care delivery system,” said Tim Lash, president of Gary and Mary West PACE. California officials consider PACE an integral part of the state’s strategy to upgrade care for aging residents.

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The National PACE Association said data it collected for 2019 shows seniors enrolled in PACE cost states 13% less on average than the cost of caring for them through other Medicaid-funded services, including nursing homes.

Perez, like 90% of PACE enrollees nationwide, is a recipient of both Medicaid and Medicare. He’s part of a population that typically has low income and multiple chronic conditions.

PACE participants who do not receive government medical benefits can pay out of their own pockets. At Gary and Mary West, the tab ranges from $7,000 to $10,000 a month, depending on the level of care.

Nationally, 50,000 enrollees participate in PACE programs at over 260 centers in 31 states. In California, PACE serves nearly 9,000 vulnerable seniors at 47 locations.

PACE programs nationally offer all services covered by Medicare and Medicaid, and staff members include nurses, primary care doctors, social workers, dietitians, drivers and personal care attendants, as well as physical, occupational and recreational therapists. PACE enrollees commonly have conditions such as vascular disease, diabetes, congestive heart failure, depression and bipolar disorder.

About two-thirds of PACE participants have some degree of cognitive impairment. The Gary and Mary West center is no exception, which is why it has alarms on all the doors. If participants become agitated, they are led to the “tranquility room,” a softly lit space with an ocean soundtrack and a recliner.

The center is California’s newest addition to a holistic system of care for frail and infirm seniors known as the Program of All-Inclusive Care for the Elderly. (Credit: Tim Ingersoll, West Health)

On weekdays, participants can arrive at the center as early as 8 a.m. and stay until 4:30 p.m. A PACE driver provides transportation to and from the center, as well as to appointments with outside specialists.

The center goes a step further than most other PACE programs: It offers dental care. Staff dentist Karen Becerra said some of her patients have cried for joy when they learned they were going to have their teeth fixed or replaced.

“These are folks who have terrible teeth,” Becerra said. “And if they have painful mouths, they have poor nutrition.”

Perez is missing teeth, but he was all smiles when he talked about his upcoming dental appointment. “They’re going to put new ones in,” he said.

The center opened with money donated by San Diego billionaires Gary and Mary West, telemarketing and telecommunications entrepreneurs. They’ve donated about $11 million to establish PACE centers around the country.

The center in San Marcos is spacious and cheery, with sofas and chairs scattered about and plenty of natural light. It’s meant to feel “like a friendly inviting living room,” said Dr. Ross Colt, a retired Army colonel who joined Gary and Mary West PACE a year ago as the primary care physician on staff.

Enrollees can repair to a patio to get fresh air or tend herbs in planter boxes. And they can participate in activities such as bingo, coloring and Trivial Pursuit, led by a recreational therapist.

Just down the hall from the main lounge are patient exam rooms decorated with photographic murals of sunsets and seascapes.

Center participants can get physical and occupational therapy in a rehabilitation gym, and the facility has a spa where they can shower or get their hair done.

Dr. Ross Colt, a retired Army colonel, joined Gary and Mary West PACE a year ago as the primary care physician on staff. (Credit: Tim Ingersoll, West Health)

The executive director, Renata Smith, recalled a woman whose husband had been bathing her with a garden hose before she joined PACE. “We’re talking about basic human dignity here,” Smith said. “The spa makes participants feel good about themselves.”

PACE programs also send personal health care aides to the homes of participants.

Twice a week, an aide named Sylvia Muro picks up Perez at his home and takes him out to shop for groceries. Sometimes they stop at McDonald’s for pancakes and sausage.

Colt said participants come to him for checkups about once a month, but he can see anyone with a medical problem on a moment’s notice.

Unlike doctors in private practices, “I have the luxury of seeing them for an hour if I need to. And I can bring them back tomorrow if I need to,” he said.

Such access can save a diabetes patient from missing an insulin injection and avoid a costly hospital admission.

“That’s what the benefit of this model is,” Colt said. “The patient doesn’t want to go stay in the hospital, the family doesn’t want them to, and society doesn’t want them to.”

Smith, the center’s executive director, noted another important benefit: “the comfort of social interaction and something to wake up to every day.”

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

For Her Head Cold, Insurer Coughed Up $25,865

Alexa Kasdan had a cold and a sore throat.

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The 40-year-old public policy consultant from Brooklyn, N.Y., didn’t want her upcoming vacation trip ruined by strep throat. So, after it had lingered for more than a week, she decided to get it checked out.

Kasdan visited her primary care physician, Dr. Roya Fathollahi, at Manhattan Specialty Care just off Park Avenue South, and not far from tony Gramercy Park.

The visit was quick. Kasdan got her throat swabbed, gave a tube of blood and was sent out the door with a prescription for antibiotics.

She soon felt better and the trip went off without a hitch.

Then the bill came.

Patient: Alexa Kasdan, 40, a public policy consultant in New York City, insured by Blue Cross and Blue Shield of Minnesota through her partner’s employer.

Total Bill: $28,395.50 for an out-of-network throat swab. Her insurer cut a check for $25,865.24.

Service Provider: Dr. Roya Fathollahi, Manhattan Specialty Care.

Medical Service: Lab tests to look at potential bacteria and viruses that could be related to Kasdan’s cough and sore throat.

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What Gives: When Kasdan got back from the overseas trip, she said, there were “several messages on my phone, and I have an email from the billing department at Dr. Fathollahi’s office.”

The news was her insurance company was mailing her family a check ― for more than $25,000 ― to cover some out-of-network lab tests. The actual bill was $28,395.50, but the doctor’s office said it would waive her portion of the bill: $2,530.26.

“I thought it was a mistake,” she said. “I thought maybe they meant $250. I couldn’t fathom in what universe I would go to a doctor for a strep throat culture and some antibiotics and I would end up with a $25,000 bill.”

The doctor’s office kept assuring Kasdan by phone and by email that the tests and charges were perfectly normal. The office sent a courier to her house to pick up the check.

How could a throat swab possibly cost that much? Let us count three reasons.

First, the doctor sent Kasdan’s throat swab for a sophisticated smorgasbord of DNA tests looking for viruses and bacteria that might explain Kasdan’s cold symptoms.

Dr. Ranit Mishori, a professor of family medicine at the Georgetown University School of Medicine, said such scrutiny was entirely unnecessary. There are cheap rapid tests for strep and influenza.

“In my 20 years of being a doctor, I’ve never ordered any of these tests, let alone seen any of my colleagues, students and other physicians, order anything like that in the outpatient setting,” she said. “I have no idea why they were ordered.”

The tests might conceivably make sense for a patient in the intensive care unit, or with a difficult case of pneumonia, Mishori said. The ones for influenza are potentially useful, since there are medicines that can help, but there’s a cheap rapid test that could have been used instead.

“There are about 250 viruses that cause the symptoms for the common cold, and even if you did know that there was virus A versus virus B, it would make no difference because there’s no treatment anyway,” she said.

(Kasdan’s lab results didn’t reveal the particular virus that was to blame for the cold. The results were all negative.)

Kasdan’s insurance company mailed her family a check for more than $25,000 to cover most of the lab tests, and the doctor’s office said it wouldn’t collect the leftover $2,530.26 from Kasdan. The insurer since has stopped payment on the check it issued and is investigating.(Shelby Knowles for KHN)

The second reason behind the high price is that the doctor sent the throat swab to an out-of-network lab for analysis. In-network labs settle on contract rates with insurers. But out-of-network labs can set their own prices for tests, and in this case the lab settled on list prices that are 20 times higher than average for other labs in the same ZIP code.

In this case, if the doctor had sent the throat swab off to LabCorp ― Kasdan’s in-network provider ― it would have billed her insurance company about $653 for “all the ordered tests, or an equivalent,” LabCorp told NPR.

The third reason for the high bill may be the connection between the lab and Kasdan’s doctor. Kasdan’s bill shows that the lab service was provided by Manhattan Gastroenterology, which has the same phone number and locations as her doctor’s office.

Manhattan Gastroenterology is registered as a professional corporation with the state of New York, which means it is owned by doctors. It may be the parent company of Manhattan Specialty Care, but that is not clear in its filings with the state.

Fathollahi, the Manhattan Specialty Care physician, didn’t respond to requests for comment. Neither did Dr. Shawn Khodadadian, listed in state records as the CEO of Manhattan Gastroenterology.

The pathologist listed on the insurance company’s “explanation of benefits” is Dr. Calvin L. Strand. He is listed in state records as the laboratory director at Manhattan Gastroenterology, as well as at Brookhaven Gastroenterology in East Patchogue, N.Y. We tried to reach him for comment, as well.

“I couldn't fathom in what universe I would go to a doctor for a strep throat culture and some antibiotics and I would end up with a $25,000 bill,” Kasdan says.(Shelby Knowles for KHN)

LabCorp, Kasdan’s in-network provider, said that they would have billed Kasdan’s insurance company about $653 for “all the ordered tests, or an equivalent.” (Shelby Knowles for KHN)

Even though Kasdan wasn’t stuck with this bill, practices like this run up the cost of medical care. Insurance companies base premiums on their expenses, and the more those rise the more participants have to pay.

More From Our Bill Of The Month Series

“She may not be paying anything on this particular claim,” said Richelle Marting, a lawyer who specializes in medical billing at the Forbes Law Group in Overland Park, Kan., who looked into this case for NPR. “But, overall, if the group’s claims and costs rise, all the employees and spouses paying into the health plan may eventually be paying for the cost of this.”

Marting said this is a common problem for insurance companies. Most claims processing is completely automated, she said. “There’s never a human set of eyes that look at the bill and decide whether or not it gets paid.”

Kasdan did pay her usual $25 copay for the office visit, and a $9.61 fee to LabCorp for a separate set of lab tests.

Resolution: “I made it very clear [to the doctor’s office] that I was unhappy about it,” Kasdan said. In fact, she told them she would report the doctor to the New York State Office of Professional Medical Conduct. Next, she reached out to “Bill of the Month,” a joint project of NPR and Kaiser Health News.

After a reporter started asking questions about the bill, BCBS of Minnesota stopped payment on the check it issued and is now investigating.

Jim McManus, director of public relations for Blue Cross and Blue Shield of Minnesota, said the company has a process to flag excessive charges. “Unfortunately, those necessary reviews did not happen in this case,” he wrote in an email.

Despite the sophisticated DNA tests and resulting $28,395.50 bill, Kasdan’s lab results didn’t reveal the particular virus that was to blame for her cold. The results were all negative.(Shelby Knowles for KHN)

The Takeaway: Surprise bills often arise when an in-network doctor or hospital involves another provider who isn’t in the patient’s insurance network, without the patient’s consent. But it is often nearly impossible for a patient to detect when that is occurring.

Patients can try to protect themselves from surprise bills by asking for details at their doctor’s appointments.

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“I always ask where they’re sending my labs or where they’re sending my images [like X-rays], so I can make sure that’s in-network with my insurance company,” attorney Marting said.

They can also probe why a test is being ordered:

“It is OK to ask your doctor, ‘Why are you ordering these tests and how are they going to help you come up with a treatment plan for me?’” said Georgetown’s Mishori. “I think it’s important for patients to be empowered and ask these questions, rather than be faced with unnecessary testing, unnecessary treatment and also, in this case, outrageous billing.”

If you’re sitting on the exam table thinking, “I won’t ask. … How much could it be?” The answer could be a lot.

New York state has a law to protect patients from surprise bills. The law requires doctors’ offices to warn patients in advance that they are using an out-of-network provider and that patients may be responsible for excess charges. If a patient doesn’t consent to the involvement of an out-of-network doctor, then they must be financially held harmless for the bill. But it doesn’t prevent the out-of-network providers from sending a bill or collecting from an insurer.

Kasdan said she was not told that the throat swab was being sent out of network at the time of her appointment, though it’s possible one of the many papers she signed included a broad caveat that some services might not be in-network.

People who suspect a bill is the result of a violation of law can report that to state authorities. In this case, the New York State Department of Financial Services investigates complaints.

You can contact NPR science correspondent Richard Harris at rharris@npr.org.

Bill of the Month is a crowdsourced investigation by Kaiser Health News and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

California AG Details ‘Historic’ Settlement Agreement In Sutter Health Antitrust Case

[Updated at 7 p.m. ET to reflect news developments.]

Sutter Health will pay $575 million to settle a closely watched antitrust case filed by California Attorney General Xavier Becerra, whose office had accused the nonprofit health care giant of using its market dominance in Northern California to illegally drive up prices.

Under terms of the agreement, Sutter will continue to operate as an integrated system. But it has agreed to end a host of practices that Becerra alleged unfairly stifled competition, including all-or-nothing contracting deals demanding that an insurer that wanted to include any one of the Sutter hospitals or clinics in its network must include all of them — even if some of those facilities were more expensive than a competitor.

The agreement includes the appointment of a jointly approved special monitor who will be charged with ensuring that Sutter is following the terms of the agreement for at least the next 10 years.

Becerra announced details of the settlement, which he termed “historic,” at a news conference in Sacramento on Friday.

“When one health care provider can dominate the market, those who shoulder the cost of care — patients, employers, insurers — are the biggest losers,” Becerra said. “Today’s settlement will be a game-changer for restoring competition in our healthcare markets.

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The terms of the agreement are subject to approval by San Francisco Superior Court Judge Anne-Christine Massullo, who is expected to rule preliminarily on the agreement in February. Among other terms, the settlement requires Sutter to:

  • Limit what it charges patients for out-of-network services
  • Increase transparency by allowing insurers and employers to give patients pricing information
  • Cease bundling services and products, and instead offer stand-alone pricing

The case is expected to have nationwide implications on how hospital systems negotiate prices with insurers.

While a settlement does not set a legal precedent, “it is strong guidance that the kinds of behavior Sutter engaged in are not going to be allowed going forward,” said Jaime King, associate dean and a professor of law at UC Hastings College of the Law. “This really opens the door for attorneys general in other states to begin examining their own health systems for similar behaviors.”

Sutter stood accused of violating California’s antitrust laws by using its market power to drive up prices. Health care costs in Northern California, where Sutter is dominant, are 20% to 30% higher than in Southern California, even after adjusting for cost of living, according to a 2018 study from the Nicholas C. Petris Center at the University of California-Berkeley that was cited in the complaint.

The case was a massive undertaking, encompassing years of work and millions of pages of documents. Had the plaintiffs prevailed in court, Sutter might have faced damages of up to $2.7 billion.

In agreeing to the terms, Sutter did not admit wrongdoing. In a statement, General Counsel Flo Di Benedetto described Sutter’s care as “affordable” and “high quality.” She also noted that Sutter had invested nearly $10 billion in new technologies and state-of-the-art facilities over the past decade.

“As an organization, we will have to evaluate future capital investments based on the impact of the settlement,” Di Benedetto said. “Despite the increasing cost of care and operating in high-wage markets, we remain focused on making healthcare more affordable for our patients.”

The case initially was filed as a class-action lawsuit in 2014 by the United Food and Commercial Workers International Union & Employers Benefit Trust (UEBT), representing multiple employers, unions and local governments whose workers use Sutter services. Becerra’s office joined the case in 2018.

“Our settlement with Sutter represents an extraordinary result for working people, their employers, and every Californian who has struggled with the high cost of healthcare,” UEBT Chair Jacques Loveall said in a statement. “From the outset, our goal has been to not only achieve justice for the members of the class, but to also put an end to the anticompetitive behavior that has allowed Sutter to charge inflated prices.”

The $575 million in damages will be distributed among the self-funded employers and union trusts that brought the case, to defray overcharges they argued they paid Sutter for worker health care. A portion will also go to lawyer fees.

As far as what consumers will see, Becerra indicated that the changes will play out in the long term as insurers are able to negotiate lower prices.

Glenn Melnick, a health care economist at the University of Southern California, said premiums are likely to drop in Northern California, though perhaps not significantly.

“It’s the first volley, the first winning point in restoring some competition to the market,” said Melnick. “Everyone is focused on the insurance companies as the bad guys, but the reason premiums are going up is because the amount they have to pay hospitals every year increases.”

In a statement, the American Hospital Association criticized the agreement, saying it would increase the cost of health care by benefiting insurers to the detriment of patients in rural and vulnerable communities.

“Unfortunately, it will be several dominant commercial health insurance companies — not consumers — that will benefit from terms that will allow those insurers to cherry-pick the hospitals with which they contract, as well as eliminate incentives for them to work with hospitals to develop and sustain value-based care,” said AHA General Counsel Melinda Hatton.

Sutter has 24 hospitals, 34 surgery centers and 5,500 physicians across Northern California, with $13 billion in operating revenue in 2018. The state’s lawsuit alleged Sutter has aggressively bought up hospitals and physician practices throughout the Bay Area and Northern California, and exploited that market dominance for profit.

Sutter Health consistently denied the allegations, saying its large, integrated health system offers tangible benefits for patients, including more seamless, high-quality care and increased access for residents in rural areas. Sutter also disputed that its prices are higher than other major health care providers, saying its internal analyses tell a different story.

Must-Reads Of The Week From Brianna Labuskes

The Friday Breeze

Newsletter editor Brianna Labuskes, who reads everything on health care to compile our daily Morning Briefing, offers the best and most provocative stories for the weekend.

Happy Friday, at last! A quick programming note: This is the last Breeze of the month (year/decade!). I’ll see you guys back here in 2020!

Since everyone seemed determined to fit at least two weeks’ of news into this past five days, though, I’m thinking today’s edition will hold you over. Let’s get to it!

In some kind of poetic timing, the long-awaited court decision about the constitutionality of the health law dropped on Wednesday — the day open enrollment ended (since it was extended because of technical glitches). I would guess one or two health wonks who are also betting aficionados won their pools with that prediction.

The big decision itself was a bit anticlimatic: The appeals court did rule that the individual mandate that requires people to have coverage was unconstitutional since Congress zeroed out the penalty so it could no longer be thought of as a tax. But the judges kicked it back to the lower court for a closer review of the whether that invalidated other portions of the law.

Out of all the things this does, the most notable is that it buys Republicans some political breathing room. GOP lawmakers were facing a repeat of the midterms where Dems capitalized on their attacks of popular provisions in the health law to sweep into the House on a blue wave. Had the ruling instead immediately struck down the law — and its guarantees of coverage for people with preexisting medical conditions — it could have been used as a potent political weapon in 2020.

For now, the health law’s fate remains in limbo — which seems to be its natural state even as it nears its 10-year anniversary.

The New York Times: 3 Legal Experts On What The Obamacare Ruling Really Means

The New York Times: Obamacare Ruling May Spare Republicans Some Political Pain

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For once, lawmakers didn’t act like college students with a term paper due at midnight— they announced their spending deal on Monday, the House passed it on Tuesday and the Senate even voted at a reasonable hour Thursday to send it to President Donald Trump.

Here are some of the health highlights:

— The smoking age will be raised to 21.

— Gun violence research is being funded for the first time in more than two decades.

— Three health law taxes, including the highly unpopular “Cadillac Tax,” are being repealed. (An early Christmas gift to insurers if ever there was one.)

— Puerto Rico’s Medicaid funding is being slashed (apparently because of personal intervention from President Donald Trump).

What was missing? Any proposals to curb surprise medical bills, which left many to think that out of the winners and losers in this deal (and there were plenty of both), patients were firmly slotted into that second category.

The New York Times: Spending Deal To Avert Shutdown Carries Key Priorities For Both Parties

The Washington Post: House Passes $1.4 Trillion Spending Bill With Trump Support That Would Gut Key Parts Of Affordable Care Act

The Associated Press: Spending Deal Would End Two-Decade Freeze On Gun Research

Modern Healthcare: Healthcare Consumers Are The Big Losers In Year-End Funding Deal

Health care was no longer the belle of the ball at the last presidential candidate debate of the decade (yes, I am that annoying person who keeps making note of that). There was a brief clash between Vice President Joe Biden and Sen. Bernie Sanders (I-Vt.) where teasing escalated to shouting — both covering well-worn ground with their points (“Medicare for All costs a lot! Not doing anything isn’t good either!). For the most part though, health care — and coverage especially — took a back seat.

Politico: The 5 Most Brutal Onstage Brawls From The Sixth Democratic Debate

Trump unveiled his plan to allow states to import drugs from Canada — which critics say looks good on paper politically but does little in reality to cut costs for patients. Mainly because Canada is over there being like, “Excusez-moi, you want to do what now?” Officials there aren’t supper jazzed about the idea of becoming America’s pharmacy, and even if they were, the supply likely could not meet our demand. Apart from that, regulation costs would certainly cut into savings and drugmakers would have to cooperate (which is even more absurd than thinking Canada wants to get on board this train).

Politico: 4 Reasons Why Trump’s Drug Importation Bill Won’t Work

Meanwhile, with their sweeping drug prices bill that passed the House, the Democrats have put Republicans  between a rock and a hard place (aka angering the powerful pharma lobby or angering voters). Things are getting tense as the GOP tries not to wind up holding the bag when drug prices are brought up on the campaign trail.

Politico: Democrats Box In Republicans On Drug Pricing

An intensive investigation by USA Today reveals widespread and startling incidents of sexual violence, routine use of physical force, poor medical care and deaths at facilities overseen by the U.S. Immigration and Customs Enforcement agency. Under the Trump administration there have been at least 29 fatalities at these facilities, including seven  suicides. With most of the country focused on the separation crisis at the border, this detention system can fly under the radar.

USA Today: Deaths in custody. Sexual violence. Hunger strikes. What we uncovered inside ICE facilities across the US

How much money does the Sackler family — which owns the firm that made Oxycontin — really have? It’s a question that’s been plaguing anyone paying attention to the opioid crisis lawsuits. The problem is, no one really knows that answer (except, I presume, the family themselves). That message was driven home once more when it was revealed that the Sacklers transferred $1.36 billion to overseas accounts and affiliated companies after 2008, part of $10.3 billion in total profits distributed out of the company.

Currently, the Sacklers have agreed to pay $3 billion as a way to settle lawsuits over their role in the opioid crisis. But when tidbits like this come out, critics of the deal are left wondering how much that would even hurt the family’s coffers.

The Washington Post: The Sackler Family Transferred $1.36 Billion In Purdue Pharma Profits Overseas, Company Says

Meanwhile, it seems undeniable at this point that another meth crisis is brewing and ready to bubble over — this time with an even more potent form of the drug. (One expert explains the difference between today’s meth and the kind from the ’90s: “It’s like they were drinking Mountain Dew and now they are injecting Red Bull.) But advocates, cities and states are struggling to hold the epidemic at bay. Why? Because public health funding these days is locked up fighting the opioid crisis.

The New York Times: A New Drug Scourge: Deaths Involving Meth Are Rising Fast

In the miscellaneous file for the week:

— What would happen if there were no restrictions on the specialists that insurance plans would cover? It sounds great for patients in theory, but a closer look at a plan for New Jersey teachers paints a grim picture of just how out-of-control that kind of strategy can get.

ProPublica: What Happens When A Health Plan Has No Limits? An Acupuncturist Earns $677 A Session.

— Even in the midst of the lung disease outbreak linked to e-cigarettes, the rates of teens who vape marijuana are skyrocketing. There is some good news, though: their use of hard drugs and alcohol is dropping off.

The New York Times: Teen Marijuana Vaping Soars, Displacing Other Habits

— There’s only one federal law that protects children who are not in state custody who are neglected and abused. Not a single state fully complies with that law — and the consequences can be deadly.

ProPublica/Boston Globe: The Law Says She Should Have Been Protected From Birth. Instead, She Was Left In The Care Of Her Drug-Addicted Mother, Who Killed Her.

— For a good, long holiday-travel read, check out this piece on the movement to have family and friends care for the body of loved ones after they die instead of having them whisked off to the funeral parlor to deal with.

The New York Times: The Movement To Bring Death Closer

And with that, I wish you a restful, joyous, wonderful last two weeks of the decade! (See, I told you I’m that person.)

Watch And Listen: The ACA In Limbo Again

Kaiser Health News:The Health Law - December 20, 2019

A decision this week from a federal appeals court in New Orleans has cast doubt again on the future of the Affordable Care Act. The court agreed with a district court judge that the law’s provision requiring people to have coverage ― called the individual mandate ― is unconstitutional now that Congress has repealed the penalty. The appeals court judges, however, sent the case back to the district judge to determine what other provisions of the law are now not valid.

Julie Rovner, chief Washington correspondent for Kaiser Health News, discusses the developments with William Brangham on PBS NewsHour on Thursday, reviewing the wide array of health initiatives that could be affected if the entire ACA is struck down and looking at the strategy for ACA advocates.

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Also, Rovner spoke with Jeremy Hobson on NPR’s “Here & Now” Thursday about the case. At risk are 20 million people who got health care coverage through the ACA and another 50 million who have preexisting conditions. The ACA requires insurers to offer coverage to people with medical problems.

Rovner also answered consumers’ questions Friday on C-SPAN’s “Washington Journal.”

HHS Secretary Azar Statement on ACA Exchange Program Integrity Final Rule

HHS Gov News - December 20, 2019

Today, the Centers for Medicare & Medicaid Services issued the Exchange Program Integrity Final Rule, which implements policies aimed at protecting taxpayer dollars by ensuring that Exchange enrollees are accurately determined eligible for premium subsidies.

HHS Secretary Alex Azar issued the following statement:

“Being good stewards of taxpayer dollars and faithfully implementing the law are among the most important duties HHS has, and that’s what we’re doing with this rule. The rule is part of much broader efforts at CMS, under Administrator Verma, to improve program integrity and reduce improper payments.

“In addition, when an exchange plan covers abortions for which public funding is prohibited by federal law, this rule requires that customers receive separate bills for that abortion coverage and for the rest of their insurance. Providing these separate bills is an essential step in implementing the Affordable Care Act’s bar on tax credits going toward coverage of abortions for which public funding is prohibited. The separate billing requirement fulfills Congress’ intent and reflects President Trump’s strong commitment to preventing taxpayer funding of abortion coverage.”

Read CMS’s press release here: https://www.cms.gov/newsroom/press-releases/cms-announces-enhanced-program-integrity-efforts-exchange

California Attempts To Revive Compassionate Cannabis Programs

Kaiser Health News:States - December 20, 2019

For years, Richard Manning knew what he needed to cope with his physical pain, rage and PTSD — much of which he traced to a career-ending knee injury he suffered while on a domestic security detail with the Marines.

Cannabis may not have been a cure-all, but it was the closest thing he’d ever had to one.

Manning, a resident of Elk Grove, Calif., didn’t have enough money to buy the daily amount of cannabis he needed, but he was able to get it through a network of charitable donors spawned by the Compassionate Use Act, a 1996 California law that allowed marijuana to be used for medical purposes.

In the wake of that law’s enactment, growers and distributors began donating part of their cannabis crop to often-tiny nonprofit collectives — and later to dispensaries —which passed it along free to low-income patients.

Using cannabis regularly helped Manning kick prescription opioids and alcohol and get back on his feet, he said.

But the donations he relied on virtually dried up after the 2016 passage of Proposition 64, which legalized marijuana for recreational use in California and began taxing it at every stage of production and distribution — no matter its ultimate destination.

It treated any cannabis leaving a shop as a sale.

That meant cannabis was taxed the same — at rates that sometimes exceeded 38% — whether it was donated or sold for profit.

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When the taxes and the heavy regulations that accompanied them took full effect in 2018, the impact on the compassionate care movement was immediate and profound. Manning and others in his situation saw their options dwindle.

Today, “the prices at dispensaries are out of reach if you need daily medicine, and the taxes are about to go up again,” said Manning, 44. “So the black market is where a lot of veterans and low-income people turn.”

The prospect of poor and sick patients being driven underground for cannabis, or losing access to it altogether, was a major impetus behind a new law, SB-34, that will remove the cultivation, retail and excise taxes on cannabis donated through compassionate care programs.

The law, signed by Gov. Gavin Newsom in October, eliminates much of the financial liability that cannabis growers and distributors face for giving their products away.

As a result, some compassionate care groups that curtailed or entirely halted their charitable ventures in the wake of Proposition 64 are now thinking about rekindling them. But even some of those who plan to participate say it’s unclear whether the full network can be revived.

“It’s a little bit hard to see right now,” said Lindsey Friedman, who runs the Shelter Project, a charitable cannabis operation belonging to Inglewood-based Jetty Extracts. “It’s a weird, gray area.”

The original intent of the Compassionate Use Act was to get cannabis to patients battling cancer, AIDS, glaucoma and other illnesses. The high cost of using it regularly was — and still is — a critical factor.

“It’s expensive, and it’s not covered by insurance,” said Kimberly Cargile, CEO of A Therapeutic Alternative, a Sacramento dispensary.

San Francisco’s Sweetleaf Collective was one of the first mom-and-pop nonprofits to collect cannabis donations and distribute them to people in need. It started in 1996, immediately after the passage of the medical marijuana law, delivering cannabis via bicycle to five AIDS patients that year.

In time, dispensaries such as Cargile’s started donation programs, and large-scale manufacturers of cannabis products jumped in.

“It’s part of the core of our company,” said Friedman, noting that Jetty began employing couriers in 2014 to deliver free cannabis each week to hundreds of cancer patients statewide, regardless of their income. Some other groups did the same.

Most non-cancer patients needed a medical card, a doctor’s recommendation or diagnosis and proof of low income to qualify for free cannabis.

The San Francisco Bay Area was a hotbed of such compassion programs, especially in neighborhoods where the bank accounts of HIV and AIDS patients had been decimated by medical costs.

Sweetleaf founder Joe Airone told of patients who said they would have died without the cannabis, which for many not only relieved pain but also restored appetites that had been diminished by heavy use of pharmaceuticals.

Veteran Richard Manning says that using cannabis regularly to cope with his physical pain, rage and PTSD helped him kick prescription opioids and alcohol. (Courtesy of Richard Manning)

The Sacramento-based Weed for Warriors Project, founded in 2014, took cannabis donations from growers and gave it to veterans. Sean Kiernan, an ex-Army airborne infantry soldier and former Wall Street hedge fund manager who heads the group, said many veterans — himself included — found relief in cannabis and were able to kick the prescription medications they took for service-related injuries, PTSD, depression and other disabilities.

Proposition 64 changed the economics. It once cost Jetty Extract about $10 a patient each month to donate cannabis, Friedman said. After Proposition 64, it cost $100 a patient, which would have saddled Jetty with a monthly tax bill of $50,000 per month for the 500 patients it served at its peak, she said.

So the company closed the Shelter Project in 2018, Friedman said. It reopened this year and now serves about 50 patients a month. Sweetleaf drastically cut its service and had to seek donations to cover taxes on the limited amount of free cannabis it did provide.

Now, with the new law set to take effect in early 2020, some of the midsize and larger players in the compassionate cannabis movement are taking tentative first steps to resuscitate their charitable operations.

Kiernan wants Weed for Warriors to begin partnering directly with small growers, creating a brand — “like Newman’s Own,” he said — that would roll proceeds into cannabis relief for veterans.

Cargile said A Therapeutic Alternative will resume the cannabis care packages it halted in 2018, with a planned donation in spring 2020 of about $40,000 worth, and Jetty Extracts is exploring whether to expand the Shelter Project.

But the era of mom-and-pop nonprofits that kick-started the movement in the 1990s may be over.

“You might be facing $15,000 in licensing fees or more,” said Manning, who formed his own collective so he could donate cannabis to family members and fellow vets, but abandoned it after the passage of Proposition 64. “How are you going to operate like that?”

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

A Veteran Started Vaping THC To Cope With Chronic Pain. Then He Got Very Sick.

Kaiser Health News:States - December 20, 2019
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As vaping has grown more popular in recent years, the trend has been fueled by the habit’s pleasurable allure: Compared with smoking cigarettes or pot, vaping is discreet and less smelly. Vaping fluids come in hundreds of flavors. There’s no tar or other byproducts of burning. And vape pens are high-tech, customizable and sleek.

But none of that mattered to Paul Lubell when he decided to try vaping. He wasn’t thinking about pleasure; he was trying to avoid pain. The retired Navy veteran turned to vaping marijuana, hoping it would help him cope with his chronic, debilitating musculoskeletal pain.

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Unfortunately, it wasn’t long before he became part of the national statistics tracking an outbreak of a vaping-related lung illness that has killed more than 50 Americans and sickened 2,400. Lubell ended up in the hospital, seriously ill from vaping an oily liquid containing extracts of THC, the psychoactive ingredient in marijuana.

Lubell, who lives in the Cleveland suburb of Beachwood, is older than most of those who have contracted what is now being called “e-cigarette or vaping associated lung injury,” or EVALI.

Three-quarters of patients with the condition have been under age 35; Lubell is 59.

Lubell during his time in the Navy in the late 1970s.(Mary Fecteau/ideastream)

But like patients in the majority of those cases, he used THC. And the latest information from the Centers for Disease Control and Prevention suggests that it’s some added ingredient in THC vapes — likely vitamin E acetate — that is causing the lung disease. The CDC is warning people to stop vaping altogether, given the risk of lung illness, which puts people who vape to manage pain in a tough position.

‘My Pain Would Be Gone’

Lubell suffers from pain in his back, neck and knees. He is not sure when his problems started, but he wonders if they are related to his days on a Navy helicopter rescue team.

“It was fun. I was indestructible and good at what I did. Everybody wanted me,” he recalled, while looking at photos of his much younger self posing on top of one of the helicopters.

Lubell sometimes jumped out of the helicopter and smacked into the water during training and rescue missions. That could have been the genesis of some of his back pain, he said. Lubell has had two back surgeries, and he also suffers from serious neck pain. Every day is a struggle, he said.

Looking for relief, he has tried many medications, including opioids such as hydrocodone, but that drug is no longer an option. Lubell is a patient at Louis Stokes Cleveland VA Medical Center, and in the wake of the national opioid addiction epidemic, the VA has revised its pain-treatment protocols.
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“The VA is not a friend of opioids at all,” Lubell said. “Unless you’re coming out of the hospital for surgery or something like that, they do not give vets opioids.”

“It leaves someone who is in chronic pain in a very tough situation, having to decide how to deal with it,” he added.

Lubell started using an electronic cigarette device paired with prefilled THC cartridges. Medical marijuana is legal in Ohio, as it is in 32 other states, plus the District of Columbia.

“When I say it took away pain — it was almost instantaneous,” he said. “Within the span of 10 minutes, my pain would be gone. … It made me capable of doing my daily activities.”

Lubell described his old vaping cartridges as tiny sticks that screwed on top of the vaping pen. When he inhaled at one end of the pen, it pulled the THC extract and other liquids in the cartridge over a heating element. Vaping was different from when he had smoked marijuana, Lubell said.

It doesn’t have a stench to it. You could do it out on the streets. It doesn’t have that — what’s the word I’m looking for? — stigma,” he said.

Hospitalized With Cough And Fever

Lubell purchased the THC cartridges from a friend at what he described as a below-market price. A few months later, in July, Lubell started running a very high fever and went to the Cleveland VA Medical Center.

“He had this cough that was persistent. He just looked very, very sick,” recalled Dr. Amy Hise, who was on the team of physicians that treated Lubell.

He was put on very strong broad-spectrum antibiotics, and yet he continued to have fevers. He continued to feel unwell. He had very flu-like symptoms,” Hise said.

Lubell waits for his doctor in an examination room at the Louis Stokes Cleveland VA Medical Center.(Mary Fecteau/ideastream)

After a few days, Lubell seemed to improve and was released, according to Hise. But then, he grew ill again.

Hise said she was surprised when he came back to the emergency department in late August.

By then, however, she had seen a new alert from the CDC about the vaping illness. Lubell had also seen reports in the media about health problems related to vaping.

“He was forthright that he had been vaping, and indeed what had happened is when he was in the hospital before, he’d stopped vaping,” Hise said. “He stopped for a period of time until he started to feel better. And then he started it up again, and that’s when his lung disease came back.”

The doctors at the VA switched tactics, taking Lubell off antibiotics and starting him on steroids, based on information provided by the CDC. Lubell was soon released and on the road to recovery.

No More Vaping

Even though vaping eased his pain, those two bouts of respiratory sickness were too much. Lubell said he won’t vape again, and his doctor endorsed that decision.

“I think there’s just too much that’s not known about what’s in these products to safely use them,” Hise said.

But Lubell is not alone in having turned to marijuana for pain management. Dr. Melinda Lawrence, a pain management specialist at University Hospitals, said many patients have told her they are trying marijuana to see if it will help.

“That is probably something that I get from patients every day,” Lawrence said. “And it’s not just people who are young, in their 20s. [There are] people in their 80s who are telling me they are looking to try anything to help with their pain.”

Even though some patients say marijuana helps their pain, there is not enough research to prove it’s broadly and reliably effective, Lawrence said.

“Personally, I don’t recommend it for my patients. But maybe after we have more studies, it can be something in the future” she said.

Lubell, who has an Ohio medical marijuana card, is still planning to use marijuana — but he won’t vape it. He turned over his equipment and leftover THC cartridges to health officials for analysis.

Yang And Sanders Use Maternal Mortality Stats To Talk About Race

“If you’re a black woman, you’re 320% more likely to die from complications in childbirth.”

Andrew Yang, businessman and Democratic presidential candidate, in comments made during the Dec. 19 Democratic presidential primary debate

In an exchange about racial inequality at December’s Democratic presidential primary debate, businessman Andrew Yang  highlighted jaw-droppingly different health outcomes between black and white women, and Vermont Sen. Bernie Sanders picked up that thread.

This story was produced in partnership with PolitiFact.

This story can be republished for free (details). “If you’re a black woman, you’re 320% more likely to die from complications in childbirth,” Yang said in a discussion about racial disparities between black and white Americans.

Sanders returned moments later, arguing, “Black women die three times at higher rates than white women.”

Those figures, which are roughly equivalent, would speak to glaring inequities in the health care system. So we decided to dig in.

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We reached out to both the Yang and Sanders campaigns for comment.

The Yang campaign referred us to data from a May 2019 report on maternal mortality disparities from the Centers for Disease Control and Prevention.

The Context, And The Data

Based on the context of the debate, we also interpreted Sanders as discussing maternal mortality gaps between black and white women — an issue that public health researchers say is a major concern, and one that’s garnered sizable attention on Capitol Hill.

The best data comes from the CDC report Yang’s team cited. The May report outlines maternal mortality disparities, using data from 2011 to 2015 and select data from 2013 to 2017. Per the CDC, 700 women in the United States were reported to die from pregnancy-related complications each year.

Non-Hispanic black women were 3.3 times as likely as non-Hispanic white women to die from complications in childbirth — data that roughly tracks with both Yang and Sanders’ stat.

So, while their phrasing may have been inelegant, the point is correct.

What’s At Stake

Experts say most of these deaths are preventable.

One issue: Hospitals that predominantly serve black women are often worse-performing than those that serve mostly white women — and that, researchers say, contributes to the gap.

Sources:

Centers for Disease Control and Prevention, “Vital Signs: Pregnancy-Related Deaths, United States, 2011-2015, and Strategies for Prevention, 13 States, 2013-2017”, May 10, 2019

Creanga, et al., “Performance of racial and ethnic minority-serving hospitals on delivery-related indicators,” American Journal of Obstetrics and Gynecology”, June 5, 2014

American College of Obstetrics and Gynecologists, “ACOG Releases Comprehensive Guidance on How to Treat the Leading Cause of U.S. Maternal Deaths: Heart Disease in Pregnancy”, May 3, 2019

Email interview with Dr. Neel Shah, Assistant Professor of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School, Dec. 19, 2019

Another issue comes from the American College of Obstetricians and Gynecologists. It released a comprehensive guide in May on preventing maternal mortality, which provided data showing that cardiovascular disease is the leading cause of pregnancy-related death, and it disproportionately affects women of color.

“Most of these deaths are preventable, but we are missing opportunities to identify risk factors prior to pregnancy and there are often delays in recognizing symptoms during pregnancy and postpartum, particularly for black women,” said ACOG former president Dr. Lisa Hollier in a press release about the guide.

Black women’s risk of dying from cardiovascular disease while pregnant is 3.4 times higher than that of white women. The American College of Obstetricians and Gynecologists said this disparity is in part due to racial bias and overt racism in the medical system, with black women’s cardiovascular disease risk not being addressed before they become pregnant.

Dr. Neel Shah, an assistant professor of obstetrics, gynecology and reproductive biology at Harvard Medical School, said that both candidates reported the CDC statistics accurately. He also reiterated that this disparity persists irrespective of education or income and stems from medical providers’ implicit bias.

“When black women express concerning symptoms, particularly pain, the health system is slower to respond,” Shah wrote via email. “The reasons are surprising but also apparent to nearly everyone who works in health care. Clinicians are trained to profile people by race — nearly every exam question in medical school tells you the race of the patient and reinforces race-based associations.”

Our Ruling

Yang said black women are 320% more likely to die from complications in childbirth, as part of his explanation of disparities between black and white Americans.

The point tracks with non-partisan expert research. We rate it True.

Warren’s Argument That Millions Can’t Afford Their Rx Drugs Holds Up

“Last year, 36 million Americans didn’t have a prescription filled because they couldn’t afford it.”

Sen. Elizabeth Warren (D-Mass.) during the Dec. 19 Democratic presidential primary debate. 

During a heated exchange over health reform during the December Democratic presidential primary debate Thursday, Sen. Elizabeth Warren turned to the topic of high prescription drug prices.

This story was produced in partnership with PolitiFact.

This story can be republished for free (details). “Last year, 36 million Americans didn’t have a prescription filled because they couldn’t afford it,” the Massachusetts senator said.

Drug prices are a persistent hot-button issue, and one of the health issues voters say they most want Washington to take on. So we decided to take a closer look.

We contacted the Warren campaign, which directed us to a February survey from the Commonwealth Fund, a highly regarded, nonpartisan think tank in Washington.

The Data

The Commonwealth data supports Warren’s point; in fact, it’s a slightly larger number than she said on the debate stage.

In 2018, the researchers estimate, 37 million non-elderly adults went without filling a prescription because they could not afford it. That’s almost 1 in 5 of the U.S. population.

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Having coverage, the researchers note, doesn’t guarantee you’ll afford medication. The survey makes a point of noting the 87 million non-elderly adults are uninsured, experienced a gap in coverage or are “underinsured” — which means they had coverage the entire year, but still faced out-of-pocket costs (excluding premiums) that imposed a substantial financial burden.

That’s another point Warren — and other candidates — repeated during the debate’s health care portion.

Sources:

PBSNewsHour/Politico Presidential Debate, Dec. 19, 2019

Email interview with Warren for President, Dec. 19, 2019

The Commonwealth Fund, “Health Insurance Coverage Eight Years After the ACA,” Feb. 2019.

Kaiser Family Foundation, “KFF Health Tracking Poll – February 2019: Prescription Drugs,” March 2019.

Kaiser Family Foundation, “Public Opinion on Prescription Drugs and Their Prices,” Nov. 20, 2019.

Gallup, “Millions in U.S. Lost Someone Who Couldn’t Afford Treatment,” Nov. 12, 2019.

“Those are people with health insurance, as well,” Warren added. “People who can’t do the copays, people without can’t do the deductibles.”

The Commonwealth paper suggests much of this “underinsurance” issue comes from deterioration of health plans Americans get through work, which is the way most non-elderly Americans get coverage.

Commonwealth isn’t the only organization to look at this question of prescription drug affordability. A November poll from Gallup surveyed more than 1,000 adults, asking them if, in the past 12 months, they had not had enough money to afford a doctor-recommended medication.

About 23% of respondents reported such an issue — a figure Gallup extrapolated to suggest 58 million Americans experiencing what it called “medication insecurity.”

Meanwhile, a February poll from the Kaiser Family Foundation found that of adults taking prescription drugs, about 1 in 4 reported some difficulty in affording that medication. (KHN is an editorially independent program of the foundation.)

The findings drive home a crucial point: Broadly, Warren’s number matches what the data shows. If anything, it could be even worse than she suggested.

Our Ruling

Warren said that last year 36 million Americans forwent a prescription because of the cost barrier.

The data supports her claim. And other research further paints a picture of widespread affordability problems.

We rate this claim True.

Democrats Debate Whether ‘Medicare For All’ Is ‘Realistic’

In the end, literally, the candidates returned to health care.

The sixth Democratic presidential debate on Thursday is likely to be best remembered for its sharp exchanges over campaign finance and a glistening fundraiser in a Napa Valley wine cave. But just before their closing statements, after lengthy discussions of impeachment, climate change and human rights in China, the seven candidates who qualified for the last debate of 2019 talked about the practicality of sweeping health care reform — specifically, “Medicare for All.”

In light of the Obama administration’s challenges passing the Affordable Care Act nearly a decade ago, former Vice President Joe Biden was asked about the likelihood of being able to replace the nation’s existing health care with a single-payer system.

“I don’t think it is realistic,” he replied.

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Biden noted that Americans are already paying taxes for a relatively small portion of the population to be covered by Medicare, suggesting taxes would skyrocket under a single-payer system.

Yes, Sen. Bernie Sanders of Vermont replied, taxes would go up under his Medicare for All plan. But premiums, deductibles and out-of-pocket expenses would disappear, he said, and there would be an annual cap on prescription drug costs.

“The day has got to come, and I will bring that day about, when we finally say to the drug companies and the insurance companies, the function of health care is to provide it for all people in an effective way,” Sanders said, “not to make profits for the drug companies and the insurance companies.”

Sen. Amy Klobuchar of Minnesota, who, like Biden, has proposed adding a public option to the existing system, took a folksier approach to criticizing Medicare for All.

“If you want to cross a river over some troubled waters, you build a bridge,” she said. “You don’t blow one up.”

It was an encore of an argument over health care reform that has become familiar to anyone who watched, well, any of the previous five debates.

But with six Democratic debates to go in the primary season, the candidates also waded into topics that focused more on care: the startling racial disparities in maternal mortality rates and the treatment of those with disabilities.

Andrew Yang, a businessman who is mostly running on his proposal to institute a universal basic income of $1,000 a month, noted that black women are 320% more likely to die in childbirth.

That disparity has prompted calls to extend Medicaid coverage, ensuring many new moms are not kicked off their health care shortly after giving birth.

And speaking as the parent of a child with special needs, Yang noted his universal basic income plan could help shift more of the responsibility for caring for those with disabilities away from cash-strapped local governments.

“We’re going to take this burden off of the communities and off of the schools who do not have the resources to support kids like my son, and make it a federal priority, not a local one, so they’re not robbing Peter to pay Paul,” he said.

Sen. Elizabeth Warren of Massachusetts, who taught children with special needs, vowed to fully fund the Individuals with Disabilities Education Act, a law passed in 1975 that was intended to provide free, specialized education to those with disabilities.

She added that she would also focus on supporting those with disabilities in housing and the workplace.

“You’ve got to go at it at every part of what we do,” Warren said. “Because as a nation, this is truly a measure of who we are.”

The seventh debate is scheduled for Jan. 14, with three more to follow in February and another two yet to be announced.

HHS Secretary Azar Statement on FDA Approval of Ebola Vaccine

HHS Gov News - December 19, 2019

On Thursday, December 17, 2019, the Food and Drug Administration approved a vaccine made by Merck for the Zaire strain of the Ebola virus, which caused more than 11,000 deaths during the 2014 West Africa outbreak and has caused more than 2,000 deaths in the current outbreak in the eastern Democratic Republic of the Congo. This is the first FDA approval of a vaccine for the prevention of this deadly virus, and HHS’s Biomedical Advanced Research and Development Authority (BARDA) provided significant support for the development of the vaccine.

HHS Secretary Alex Azar issued the following statement:

“The first-ever FDA approval of a vaccine for the prevention of Ebola is a triumph of American global health leadership. From research and development to support for manufacturing, the U.S. government played an integral role in advancing the development of Merck’s vaccine. The newly approved vaccine, as well as investigational therapeutics and other tools supported by the U.S. government, is playing a huge role in saving lives during the current Ebola outbreak in the Democratic Republic of the Congo. When I led the U.S. delegation to Central Africa in September to learn more about the situation on the ground, we underscored that ending the Ebola outbreak is one of the top global health priorities for the Trump administration. We will continue strongly supporting the DRC government, other governments in the region, and the World Health Organization in their work until the Ebola outbreak is brought to an end, and we will continue working with governments around the world to prepare for and prevent such infectious disease outbreaks in the future.”

Read the FDA’s press release here: https://www.fda.gov/news-events/press-announcements/first-fda-approved-vaccine-prevention-ebola-virus-disease-marking-critical-milestone-public-health

Read Secretary Azar, CDC Director Robert Redfield, and Director of the National Institute of Allergy and Infectious Diseases Anthony Fauci’s op-ed about their trip to Central Africa in September and the U.S. commitment to ending the Ebola outbreak: https://www.hhs.gov/about/leadership/secretary/op-eds/on-front-lines-trump-administrations-ebola-response.html

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