Unconscious bias can be subtle, but, as this new report shows, it may be one of the factors behind race-linked health disparities seen across the U.S.

This article first appeared January 11, 2019 on Kaiser Health News.

By Kristian Foden-Vencil, Oregon Public Broadcasting

A recent study out of Oregon suggests emergency medical responders — EMTs and paramedics — may be treating minority patients differently from the way they treat white patients.

Specifically, the scientists found that black patients in their study were 40 percent less likely to get pain medication than their white peers.

Jamie Kennel, head of emergency medical services programs at Oregon Health and Science University and the Oregon Institute of Technology, led the research, which was presented in December at the Institute for Healthcare Improvement Scientific Symposium in Orlando, Fla.

The researchers received a grant to produce the internal report for the Oregon Emergency Medical Services department and the Oregon Office of Rural Health.

Outright discrimination by paramedics is rare, the researchers say, and illegal; in these cases, unconscious bias may be at work.

A few years ago, Leslie Gregory was one of a very few black female emergency medical technicians working in Lenawee County, Mich. She said the study's findings ring true based on her experience.

She remembered one particular call — the patient was down and in pain. As the EMTs arrived at the scene, Gregory could see the patient was black. And that's when one of her colleagues groaned.

"I think it was something like: 'Oh, my God. Here we go again,'" Gregory said. She worried — then, as now — that because the patient was black, her colleague assumed he was acting out to get pain medication.

"I am absolutely sure this was unconscious," added Gregory, who now lives and works in Portland, Ore., where she founded a nonprofit to spread awareness about racial disparities in health care. "At the time, I remember, it increased my stress as we rode up on this person. Because I thought, 'Now am I going to have to fight my colleague for more pain medication, should that arise?'"

Unconscious bias can be subtle — but, as this new report shows, it may be one of the factors behind race-linked health disparities seen across the U.S.

The study looked at 104,000 medical charts of ambulance patients from 2015 to 2017. It found that minority patients were less likely to receive morphine and other pain medication compared with white patients — regardless of socioeconomic factors, such as health insurance status.

During a shift change at American Medical Response headquarters in Portland, EMTs and paramedics discussed the issue with a reporter as they got their rigs ready for the next shift.

Jennifer Sanders, who has been a paramedic for 30 years, was adamant that her work is not affected by race.

"I've never treated anybody different — regardless," said Sanders.

Most of the emergency responders interviewed, including Jason Dahlke, said race doesn't affect the treatment they give. But Dahlke also said he and some of his co-workers are thinking deeply about unconscious bias.

"Historically it's the way this country has been," Dahlke said. "In the beginning, we had slavery and Jim Crow and redlining — and all of that stuff you can get lost in on a large, macro scale. Yeah. It's there."

Asked where he thinks unconscious bias could slip in, Dahlke talked about a patient he just treated.

The man was black and around 60 years old. Dahlke is white and in his 30s. The patient has diabetes and called 911 from home, complaining of extreme pain in his hands and feet.

When Dahlke arrived at the patient's house, he followed standard procedure and gave the patient a blood glucose test. The results showed that the man's blood sugar level was low.

"So it's my decision to treat this blood sugar first. Make sure that number comes up," Dahlke said.

He gave the patient glucose — but no pain medicine.

Dahlke said he did not address the man's pain in this case because by the time he had stabilized the patient they had arrived at the hospital — where it was the responsibility of the emergency department staff to take over.

"When people are acutely sick or injured, pain medication is important," Dahlke said. "But it's not the first thing we're going to worry about. We're going to worry about life threats. You're not necessarily going to die from pain, and we're going to do what satisfies the need in the moment to get you into the ambulance and to the hospital and to a higher level of care."

Dahlke said he is not sure whether, if the patient had been white, he would have administered pain medicine, though he doesn't think so.

"Is it something that I think about when I come across a patient that does not look like me? I don't know that it changes my treatment," he said

Asked whether treatment disparities might sometimes be a result of white people being more likely to ask for more medications, Dahlke smiled.

"I wonder that — if, in this study, if we're talking about people of color being denied or not given narcotic medicines as much as white people, then maybe we're overtreating white people with narcotic medicines."

Research has found African-Americans more likely to be deeply distrustful of the medical community, and that might play a role in diminished care, too. Such distrust is understandable and goes back generations, said Gregory.

"How can a person of color not disrespect a system that is constantly studying and talking about these disparities, but does nothing to fix it?" she asked.

Gregory wrote an open letter to the Centers for Disease Control and Prevention in 2015, asking it to declare racism a threat to public health.

Past declarations of crisis — such as those focusing attention on problems such as smoking or HIV — have had significant results, Gregory noted.

But the CDC told Gregory, in its emailed response, that while it supports government policies to combat racial discrimination and acknowledges the role of racism in health disparities, "racism and racial discrimination in health is a societal issue as well as a public health one, and one that requires a broad-based societal strategy to effectively dismantle racism and its negative impacts in the U.S."

Kennel said false stereotypes about race-based differences in physiology that date to slavery also play a role in health care disparities. For example, despite a lack of any supporting science, some medical professionals still think the blood of African-Americans coagulates faster, Kennel said, citing a recent study of medical students at the University of Virginia.

Another question in the survey asked the students whether they thought African-Americans have fewer pain receptors than whites. "An uncomfortably large percentage of medical students said, 'Yes, that's true,'" said Kennel.

On top of that, he said, EMTs and paramedics often work in time-pressured situations, where they are limited to ambiguous clinical information and scarce resources. "In these situations, providers are much more likely to default to making decisions [based] on stereotypes," he said.

Disparities in health care are well-documented. Whites tend to get better care and experience better outcomes, whether they're in a doctor's office or the ER. But before Kennel's study, nobody knew whether the same was true in the back of an ambulance.

And they nearly didn't get to know, because the research required ambulance companies to release highly sensitive data.

"We were prepared to maybe not look that great," said Robert McDonald, the operations manager at American Medical Response in Portland. AMR is one of the nation's largest ambulance organizations, and it shared its data from more than 100,000 charts with Kennel.

Some people chalk up the disparities he found to differences in demography and health insurance status, but Kennel said he controlled for those variables.

So now that AMR knows about disparities in its care, what can the company do?

"My feeling is we're probably going to put some education and training out to our folks in the field," McDonald said.

In addition, he said, AMR is going to hire more people of color.

"We want to see more ethnicities represented in EMS — which has historically been a white, male-dominated workforce," McDonald said.

AMR's policies must change, too, he added. The company has purchased software that will enable patients to read medical permission forms in any of 17 different languages. And the firm is planning an outreach effort to communities of color to explain the role of EMS workers.

'I think this sets the standard for the unique role of Medicaid managed care in bridging health care and social services,' said a George Washington University health law and policy professor.

This article first appeared January 07, 2019 on Kaiser Health News.

By Phil Galewitz

Emilia Ford became pregnant at 15 and, after her daughter was born, dropped out of high school.

As she held down different jobs during the past decade — including housekeeping and working in a relative's retail store — she always thought about going for her GED to show she met high school academic skills.

But the Brookhaven, Pa., woman needed assistance finding tutors and paying for the set of four tests, which cost $20 each.

She found help from an unexpected source: her Medicaid health plan.

AmeriHealth Caritas, a Philadelphia-based insurer with 2 million Medicaid members in Pennsylvania and five other states, helps connect members with nonprofit groups providing GED test preparation classes, offers telephone coaching to keep members on track and pays the testing fees.

Ford is one of 62 plan members who have earned a GED certificate since the benefit began in 2013.

"I could not believe this was something a health insurance company would do," said Ford, 25. "I thought health insurers only paid for medical costs."

Not anymore.

Medicaid health plans are starting to pay for non-traditional services such as meals, transportation, housing and other forms of assistance to improve members' health and reduce medical costs.

That change follows efforts by state Medicaid programs to give health plans financial incentives to control spending, said Jill Rosenthal, senior program director for the National Academy for State Health Policy.

Rather than continue to pay a set fee each month to cover members' health costs, many states are implementing policies that let health plans share in any savings they can demonstrate. That provides motivation for insurers to address factors such as literacy and poor housing, which can drive up health costs.

"Health plans now have incentives for them to find the root causes of problems that will reduce costs that will benefit the plan, its beneficiaries and the states," Rosenthal said.

AmeriHealth Caritas CEO Paul Tufano said studies show people with lower educational levels tend to be in poorer health. "Helping members attain their GED can be incredibly consequential for them to live the kind of life they want to live," he said.

But Tufano acknowledged that only a small fraction of people who need the assistance reach out for it. About 1,000 members have started GED training through the insurer in Pennsylvania, Louisiana, South Carolina and Delaware.

"Many of our members are just surviving to keep their heads over water, holding on to jobs and dealing with issues like safe housing, access to food and transportation to get to work or doctor," he said.

AmeriHealth Caritas is one of just a handful of Medicaid health plans that offer a GED benefit.

WellCare, which covers 2.2 million Medicaid recipients in Missouri, Nebraska, Georgia, Kentucky, Hawaii and Illinois, had 226 members sit for their GED exams since the plan began paying for it in 2012, said spokeswoman Alissa Lawver. The Tampa-based plan does not know how many passed.

A Wellcare survey of its Medicaid adult members in Georgia in 2012 found that about 20 percent did not have a high school diploma or a GED.

"There is a significant relationship between education and health," Wendy Morriarty, president of WellCare's Ohana Health Plan in Hawaii, said when launching the benefit in 2016. "A GED is a tool that can lead to increased opportunities for our members to attend college, seek higher-paying jobs and find stable housing. This benefit has the ability to improve the health and well-being of local families and communities."

Advocates for Medicaid praise the health plans' efforts.

"I think this sets the standard for the unique role of Medicaid managed care in bridging health care and social services," said Sara Rosenbaum, health law and policy professor at George Washington University.

Ford said having a coach at AmeriHealth walk her through the sign-up process for GED classes, help her register for tests and call her twice a week to keep her motivated was vital to her success. The program also offered child care and transportation to the prep classes and exam sites. She started in May 2017, taking two classes a week, and passed her exams last summer.

When she finished, AmeriHealth hired Ford as an intern in its member services department. In December 2017, the insurer hired Ford to a full-time position — with health benefits — to work as a GED coach for other Medicaid members.

The job meant Ford became the first of nine siblings to get off Medicaid and find employer-based coverage.

"I feel like I was saved from the struggle I was going through," Ford said. "This is something big that my family was proud of." While she was growing up, she said, her father drove a school bus and her mom took care of the kids.

In the past year, Ford has helped 12 plan members earn their GEDs and she's coaching 30 more.

"I can tell them I have been where you are on the other side of the phone and can share my experience and it helps give them more trust in me," Ford said.

"The hardest thing is not giving up even after failing a test and being able to get back up and push yourself and get over the discouragement," she said. "There is always something good that you can take from a bad situation."

The FDA is supposed to inspect all factories, foreign and domestic, that produce drugs for the U.S. market. But a review of inspection records, recalls, warning letters, and lawsuits reveals how poorly manufactured or contaminated drugs can reach consumers.

This article first appeared January 04, 2019 on Kaiser Health News.

By Sydney Lupkin

Photos by Heidi de Marco

ANN ARBOR, Mich. — Despite the jackhammer-like rhythm of a mechanical ventilator, Alicia Moreno had dozed off in a chair by her 1-year-old’s hospital bed, when a doctor woke her with some bad news: The common stool softener her son, Anderson, was given months earlier had been contaminated with the bacterium Burkholderia cepacia.

Suddenly, Anderson’s rocky course made medical sense. B. cepacia was the same unusual bacterium mysteriously found in the boy’s respiratory tract, temporarily taking him off the list for a heart transplant. The same bacterium resurfaced after his transplant and combined with a flu-like illness to infect his lungs. He’s been on a ventilator ever since.

The tainted over-the-counter medicine, docusate sodium, routinely prescribed to nearly every hospitalized patient to avert constipation, caused Anderson to suffer "serious and dangerous life-threatening injuries," a lawsuit filed by his family alleges. The drug was eventually recalled, but only after a Texas hospital staff noticed an uptick in B. cepacia infections, prompting a six-month investigation that led back to the tainted drug and its Florida manufacturing plant.

"Something that was supposed to help him hurt him," Alicia Moreno said.

Since the start of 2013, pharmaceutical companies based in the U.S. or abroad have recalled about 8,000 medicines, comprising billions of tablets, bottles and vials that have entered the U.S. drug supply and made their way to patients’ medicine cabinets, hospital supply closets and IV drips, a Kaiser Health News investigation shows. The recalls represent a fraction of the medicines shipped each year. But the flawed products contained everything from dangerous bacteria or tiny glass particles to mold — or too much or too little of the drug’s active ingredient.

Over the same period, 65 drug-making facilities recalled nearly 300 products within 12 months of passing a Food and Drug Administration inspection — as was the case with the stool softener, according to a KHN analysis of recall notices and inspection records kept by the FDA.

Those recalls included more than 39,000 bottles of the HIV drug Atripla laced with "red silicone rubber particulates," nearly 37,000 generic Abilify tablets that were "superpotent," and nearly 12,000 boxes of generic Aleve (naproxen) that were actually ibuprofen, according to the recall data KHN examined.

The medicine alleged to have sickened Anderson Moreno seriously infected at least 63 other people in 12 states, according to reports by the FDA and Centers for Disease Control and Prevention. The drug was made at a PharmaTech plant in Broward County, Fla. That same plant passed an FDA inspection even while it was making bacteria-laced products, according to a KHN review of the inspection records.

PharmaTech did not respond to KHN’s requests for comment. A lawyer for the drugmaker filed a motion to dismiss the lawsuit in April, but it was not granted. In follow-up court records, PharmaTech has denied claims against it.

Like other FDA commissioners before him, Scott Gottlieb has called his agency’s drug oversight program the "gold standard" for safety and effectiveness.

But veteran industry consultant John Avellanet, who has trained FDA inspectors, questions how effective the FDA’s drug plant inspections actually are. "It’s so easy" for FDA inspectors to miss things because they’re working with confusing regulatory terms and standards that are often decades out of date, Avellanet said.

Just how often people are sickened or die from tainted drugs is next to impossible to determine. No government agency tracks cases unless they’re linked to a major outbreak among hospital patients. And sudden, seemingly random illnesses in disparate places are notoriously hard to link to a tainted drug. That’s in part because drugmakers don’t have to divulge which products are made in which manufacturing plants, since that is regarded as proprietary information.

The result: Even someone who buys drugs for a major hospital can’t track down where a potentially dangerous product came from, said Erin Fox, who purchases medicines for University of Utah Health hospitals.

"Patient safety should come first," she said, adding that the KHN analysis indicates "our drug quality is probably not what we think it is," and calling it a "scary" reality. "Something does need to change if this is happening this many times and we’re having patients receiving contaminated products."

The FDA declined to be interviewed for this story, but responded to written questions.

"While the FDA would prefer that no drug be distributed that later is recalled, we do not think that a recall indicates a failure of FDA inspection and surveillance programs," FDA spokesman Jeremy Kahn said in an email. He said inspectors "may not uncover all issues or practices that may eventually result in a problem leading to a recall" and that "not all recalls are the result of poor manufacturing practice."

The PharmaTech Story

"Lucky fin, lucky fin, lucky fin," Alicia Moreno, 30, cheered as she untangled her now 3-year-old son’s stroke-weakened arm from a sweater and his portable ventilator in the back seat of the car for yet another four-hour drive to see doctors in Ann Arbor, Mich. In the Disney movie "Finding Nemo," Nemo’s father calls the young fry’s smaller fin his "lucky fin."

While her husband drives, Alicia pulls out a clear plastic case of syringes and watches the clock on the dashboard. Anderson needs about two dozen different medicines every 24 hours, and Alicia administers them via a port in his belly at designated times.

Alicia Moreno spends the day with her son, Anderson.(Heidi de Marco/KHN)

It wasn’t always like this. Anderson appeared healthy until his 6-month checkup in May 2016, his mother said. Partway through the exam, the Morenos rushed their baby to a nearby hospital and learned he was in heart failure and would need a transplant to survive. That’s where he received the tainted stool softener, his lawyers allege. The hospital where Anderson eventually received his transplant confirmed via email that Anderson tested positive for the same strain of B. cepacia involved in the outbreak traced back to PharmaTech’s contaminated drug.

In July, according to the family, Anderson started to have difficulty breathing and his temperature spiked to 106 degrees, which landed him in the ICU, where doctors and nurses packed him with ice and rushed to find the cause. Their tests turned up positive for B. cepacia, a bacterium found in untreated water that doesn’t typically make healthy people sick. Anderson’s status on the transplant list was put on hold, and his heart condition worsened. He was placed on a machine that transferred blood outside his body, oxygenated it and pumped it back in.

Anderson finally got a heart transplant in November 2016, but four days after doctors closed his chest, his fever was back and his lungs kept getting worse, requiring more complicated machinery. Tests came back positive for a flu-like virus and B. cepacia, according to the hospital.

"Where did he get it?" his parents pleaded. At the time, no one knew.

Anderson Moreno uses a portable ventilator because of his impaired lung capacity.(Heidi de Marco/KHN)

How Tainted Drugs Slip Through the Cracks

The FDA is supposed to inspect all factories, foreign and domestic, that produce drugs for the U.S. market. But a KHN review of thousands of FDA documents — inspection records, recalls, warning letters and lawsuits — offers insight into the ways poorly manufactured or contaminated drugs reach consumers: Inspectors miss serious hazards. Drugmakers fail to meet standards even after the FDA has taken enforcement action. Hundreds of plants haven’t been inspected for years, if ever.

Last July, for example, the FDA announced the first of many voluntary recalls of the blood pressure medicine valsartan because some tablets contain a cancer-causing impurity called N-nitrosodimethylamine (NDMA). They would later find a similar carcinogen, N-nitrosodiethylamine (NDEA), in valsartan pills. Over the prior two years, investigators had detected worrisome problems in two overseas factories involved in the manufacturing of the drug.

In 2017, FDA investigators found rust, chipping paint and deteriorating equipment at a plant run by Zhejiang Huahai Pharmaceutical Co. in Zhejiang, China. Plant staffers weren’t properly testing and investigating "anomalies" in their drugs, dismissing problematic test results, the FDA said at that time. Inspectors also found "black metallic particles" and other problems in some unidentified drugs.

The FDA inspected the plant in July 2018 after complaints about NDMA from a facility further down the drug supply chain. The FDA put the facility on import alert in late September and issued a warning letter in November detailing deficiencies, including "Failure of your quality unit to ensure that quality-related complaints are investigated and resolved."

At a facility of Hetero Labs in India, in 2016, FDA inspectors found colored and white residue in components, some of the factory’s tablets were twice as thick as others, and employees were shredding documents in the middle of the night. The FDA issued a warning letter to the company as a result of the inspection.

Plants making drugs for U.S. consumers are supposed to be inspected every few years, according to a risk-based system. However, in the past decade more than 2,500 facilities, both foreign and domestic, have gone more than five years without an FDA drug-quality inspection, a KHN analysis found. The FDA has no drug-quality inspection records over the past decade for more than 1,200 domestic plants and nearly 400 foreign plants, excluding those that make animal drug products, according to the analysis. Gottlieb said in December that he hopes to clear the backlog of uninspected drug facilities by the end of September 2019.

At best, the inspections are a snapshot in time, and involve looking at processes rather than evaluating the drugs themselves, said drug-quality specialist Dinesh Thakur, who has worked for drugmakers. The inspections might take place while the facility is making only one of a dozen or so drugs that it usually manufactures.

"The implicit assumption … is that if the [manufacturing] processes are sound, the product will be of good quality," said Thakur, who raised the alarm about quality-control problems at generics drugmaker Ranbaxy, resulting in a 2013 guilty plea and a $500 million settlement. "Your data tells us this is not true."

Many inspections, he said, are "stage-managed," so that factories pass on the appointed day, but "once the inspectors leave, it’s a completely different story."

David Gortler, a former FDA medical officer, said most drug plant inspections involve looking over paper records and trusting that they’re real, instead of randomly testing medicines.

"Anybody can write down anything on a piece of paper," said Gortler, who is now a consultant at FormerFDA.com. He added that FDA inspectors aren’t reprimanded — or even told — if they’ve passed a plant that issued a recall shortly thereafter.

A Lucky Break Solves A Mystery

The contaminated stool softener alleged to have sickened Anderson Moreno was one of many drugs recalled by plants shortly after they passed an FDA inspection. The bacteria was detected only after an outbreak of disease — and after a good deal of medical sleuthing.

More than 1,000 miles away from Anderson’s ICU bed in Michigan, staff at Texas Children’s Hospital’s pediatric ICU in Houston had diagnosed three cases of B. cepacia in one week in February 2016, according to a 2017 medical journal article published in Infection Control and Hospital Epidemiology. It was odd because there had been no cases the previous year.

Hospital staff members embarked on a months-long investigation and by July had identified 24 victims, whose median age was under 2 years old. Patients had the same strain of the bacteria in their blood, their respiratory tracts, their urine or their stool, according to the article.

Samples matched the bacteria found in liquid docusate, the stool softener, the researchers wrote.

The hospital alerted the CDC and other public health officials of its findings. The CDC would eventually identify 63 confirmed and 45 suspected serious B. cepacia infections in 12 states tied to the contaminated drug.

A 36-day FDA inspection of PharmaTech in Davie, Fla., that ended Aug. 9, 2016, revealed that the bacteria was in water used to clean equipment and make liquid products. FDA inspectors concluded that the bacterium made it into the facility’s drugs starting in 2015 and was still present in the water.

Anderson was treated with the stool softener in May 2016. His parents filed suit in September 2017 in PharmaTech’s home of Broward Country, Fla., against the drugmaker and others in the drug supply chain, alleging the drug was contaminated and caused him grievous damage. PharmaTech, which did not return KHN’s requests for comment, unsuccessfully filed a motion to dismiss and has denied all charges in a subsequent filing.

A 9-month-old girl in Pittsburgh who had received the stool softener died on May 4, 2016, according to a lawsuit her family filed in July 2017 in the U.S. District Court for the Western District of Pennsylvania. Her mother learned about the drug recall by chance and asked the hospital whether her deceased daughter received the tainted drug, her lawyer told KHN. The family filed charges against PharmaTech and others in the drug supply chain in a wrongful death lawsuit. The court rejected PharmaTech’s motions to dismiss and strike, and the drugmaker denied liability in a subsequent filing. In November 2017, a lawyer representing PharmaTech in that wrongful death case told the Orlando (Fla.) Sun Sentinel that it will defend itself against the allegations and couldn’t comment further "because of the ongoing nature of litigation."

According to federal records, FDA inspectors had a chance to catch the contamination during their March 2016 inspection, but the PharmaTech plant passed with no citations. PharmaTech CEO Ray Figueroa saluted the inspection results in a press release, calling it "a testimony to PharmaTech’s commitment to world-class quality."

How Things Can Go Wrong

The FDA has issued thousands of enforcement actions against drug plants over the years, citing safety violations, issuing warning letters and blocking imports from certain foreign plants. In rare cases, the FDA can also seize drug products and has done so 23 times in the past decade. The last drug seizure was more than two years ago, according to FDA records.

In an emailed statement, FDA chief Gottlieb said the FDA is "taking new steps" to identify problems before they occur and it is "not shy" to use its powers to mitigate risks.

But the system can be stymied or gamed and the FDA’s enforcement abilities are limited. For instance, it doesn’t have the power to issue a mandatory recall, and manufacturing citations don’t come with fines.

Many cases come to light only when a whistleblower sounds an alarm.

Thakur, the Ranbaxy whistleblower, said officials in other countries sometimes tip off plants about "surprise" FDA inspections. And FDA inspectors often have to rely on translators hired by the drug companies, said Avellanet, who has been a drug facility inspection consultant for more than 20 years.

At Nippon Fine Chemical in Japan, employees stood "shoulder-to-shoulder" to keep an FDA official out in December 2015, according to an enforcement letter sent to the plant and published online.

Less than a year later, Vikshara Trading & Investments Ltd. in India allegedly faked a worker strike to block the entrance to the plant, according to an FDA enforcement document that described the manufacturer’s "false statements." When inspectors were eventually allowed in, the lights were kept off.

"Our investigator had to perform parts of the walkthrough in the dark, using a flashlight," the FDA warning letter reads, adding that an unidentified powder was "scattered" and "caked on the floor" in production areas and detected on finished drug products.

Two former employees have filed a whistleblower suit against Gilead Sciences, alleging it lied to the FDA about using a drug-manufacturing facility in South Korea, when it was actually using an unregistered facility in China. According to the civil complaint filed in September 2014 in U.S. District Court for the Northern District of California, the ingredient produced at Synthetics China and used in HIV drugs Truvada and Atripla contained "glass-like shards," "black rubber-like particles," "plastic-like particles," "small stone or pebble-like particles" and "metal shards."

The whistleblowers alleged Gilead’s Alberta, Canada, plant was tasked with sieving contaminants and helping to conceal where the ingredient was made.

They said one batch of the ingredient was contaminated with arsenic, chromium and nickel. Another had a dangerous bacterium called Bacillus cereus, according to the whistleblowers’ suit. Still, Gilead released the product and didn’t initiate a recall, the whistleblowers alleged.

Years after the whistleblowers stopped working for Gilead, the drugmaker issued two voluntary recalls of HIV drugs in 2014, about seven months apart. Both recalls cited contamination with red silicone rubber particulates.

Anderson Moreno uses a portable ventilator because of his impaired lung capacity.(HEIDI DE MARCO/KHN)

Gilead declined to comment. Gilead has fought the lawsuit, alleging that since the government knew of the allegations and did not penalize it by denying drug approvals or payments, the suit could not move forward. In 2015, a federal judge dismissed the case, but a panel from the 9th District Court of Appeals reversed that decision in 2017. Now the Supreme Court may hear it; in April 2018, it invited the solicitor general to file a brief, "expressing the views of the United States." The Justice Department filed a brief in November, saying pursuing the lawsuit is “not in the public interest."

Since the FDA has little power to force a drugmaker to fix problems or issue recalls, FDA inspectors often flag the same violations again and again. A KHN analysis found that over the past decade 70 drug plants — most of them domestic — were penalized for the same violation at least four times. And more than a third of those plants has issued a recall at some point.

Altaire Pharmaceuticals in New York was cited five times by FDA inspectors for inadequate "procedures for sterile drug products." In 2013, it recalled 363,746 bottles of generic eye drops sold at CVS, Target and Walmart over sterility concerns — namely mold — because the preservative in the product "may not be effective" through the expiration date. Overall, Altaire was told to correct 15 violations at least twice.

KHN attempted to contact Altaire Pharmaceuticals, but the company did not reply.

Kept In The Dark

About a year after the initial PharmaTech recall in 2016, the FDA announced another recall for the same drugs and the same bacterium: B. cepacia. When Erin Fox saw the second recall, she thought it was a mistake. The alert said to avoid drugs made by PharmaTech under several labels "and possibly [products from] other companies." What other companies? Fox wondered. How could they not know which ones?

Doctors at the hospital asked Fox to remove all PharmaTech-made products from the shelves, but because of lax labeling laws, she said, she couldn’t be sure which those were. Drug labels need to include only the manufacturer, the packer or the distributor — not all three — so the doctors suggested she call PharmaTech and ask what else it manufactures and for whom.

"Of course," Fox said, "they wouldn’t tell us."

Government oversight fades as taxpayer money filters down through layers of companies eager to seize on Medicaid's substantial growth under the ACA. Medicaid officials say they have authority only over the health plans, not their subcontractors.

This article first appeared January 03, 2019 on Kaiser Health News.

By Chad Terhune

Marcela Villa isn't a big name in health care — but she played a crucial role in the lives of thousands of Medicaid patients in California. Her official title: denial nurse.

Each week, dozens of requests for treatment landed on her desk after preliminary rejections. Her job, with the assistance of a part-time medical director, was to conclusively determine whether the care — from doctor visits to cancer treatment — should be covered under the nation's health insurance program for low-income Americans.

She was drowning in requests, she said, and felt pressed to uphold most of the denials she saw. "If it was a high-dollar case, they tried to deny it," Villa said. "I told them you can't deny it just because it's going to cost $20,000."

Villa, 32, did not work for the government. She did not even work for an insurer under contract with the government. She worked for a company now called Agilon Health. Owned by a private equity firm, it's among the legion of private subcontractors looking to profit from Medicaid patients.

California's Medicaid program, known as Medi-Cal, has determined that the Long Beach company, which was paid to coordinate care for about 400,000 patients, improperly denied or delayed care for at least 1,400 of them, state officials confirmed. The state Department of Managed Health Care is investigating further.

The state findings, along with internal company documents and a whistleblower complaint obtained by Kaiser Health News, shine a light on the potential dangers of outsourcing care for poor people. Government oversight, not rigorous to begin with, fades as taxpayer money filters down through layers of companies eager to seize on Medicaid's substantial growth under the Affordable Care Act. Medicaid officials say they have authority only over the health plans, not their subcontractors.

In an interview, Agilon chief executive Ron Kuerbitz acknowledged that some patients experienced modest delays in care but disputed that any suffered unjustified denials. He noted that an internal investigation by the company found no evidence of "systemic" denials and that most of the problems existed before Agilon took over another firm, Primary Provider Management Co., in 2016.

"We did the right thing when it was identified," Kuerbitz said of the problems. "We disclosed it, we investigated it, and we pursued a remedial path."

Such concerns are not isolated to one company. Last year, KHN reported on similar irregularities at SynerMed, a Medicaid subcontractor that coordinated care for about 650,000 patients in California.

In response to a whistleblower complaint, the state Medicaid program said it found "widespread deficiencies" at SynerMed that put patients "in imminent danger of not receiving medically necessary healthcare services." The company's staffers had falsified documents for years to cover up improper denials of care, according to state officials.

Then SynerMed abruptly shut down, and some of its patients moved to Agilon's medical groups.

Skimping On Services?

Nearly three-quarters of the 73 million low-income Americans on Medicaid are now in managed care, in which states pay health insurers fixed monthly amounts for each enrollee to cover the range of services they need.

Under this system, keeping patients as healthy as possible is one way to make money. Another is to deny or skimp on services.

Increasingly, Medicaid plans outsource the work of managing patients' health and medical treatment to subcontractors like Agilon — passing along a share of the government money coupled with the financial risk posed by a fixed budget.

These firms can be powerful gatekeepers. They run physician groups, bear responsibility for forming doctor networks and judge whether a request for care is necessary.

Agilon is a big player in California — doing business with insurers such as Molina Healthcare and Blue Shield of California — and it's now expanding in other states like Texas and Ohio.

Primary Provider Management Co. ran several medical groups, including Vantage Medical Group with more than 5,000 physicians across Southern California. By building off PPMC's base of Medicaid enrollees in California, the New York private equity firm that owns a majority stake in Agilon — Clayton, Dubilier & Rice — sought to coordinate care in Medicaid and Medicare Advantage plans across the country. (CD&R did not respond to interview requests.)

For several years, the problems at PPMC, and then Agilon, went undetected. Then, in early 2018, Agilon disclosed to the California Department of Managed Health Care its discovery that employees had been altering records prepared for auditors, which it said was not known to top management.

According to an internal report, completed in May and obtained by KHN, staffers had been falsifying documents since at least 2014 to pass audits by health plans. Employees were changing dates, for example, to cover up delays or withholding certain files so they couldn't be reviewed.

That same month, an anonymous whistleblower sent a letter to health plans and government officials, urging them to investigate "illegal, unethical" conduct at the firm. "Senior management delays treatments for cancer patients without any regard of patient's well-being, to save their dollars," the whistleblower wrote in a two-page letter reviewed by KHN. "They brag about how profitable we are."

In response to the allegations raised by the whistleblower and state, Agilon opened another internal investigation. That second report, finished in June, found inadequate staffing to handle the volume of work, various shortcuts and practices outside industry "norms" and improperly denied claims. Both internal reports were released to the state.

A top official Inland Empire Health Plan, one of the largest Medicaid insurers in the country, said the plan also looked into Agilon's conduct and found instances in which its patients were harmed.

In an interview, Inland Empire CEO Bradley Gilbert said Agilon denied a patient's transfusions for anemia, causing the person to be hospitalized. It also improperly denied cardiac rehabilitation to a patient recovering from a heart attack, he said. Inland Empire canceled its contract with Agilon's Vantage Medical Group in August, he said.

A 'Manager Told Me To Do It'

Agilon's June report depicts an operation that was often stretched thin: Nurses were handling 120 to 200 requests for care per day, on average, with no full-time medical director to review the findings.

From 2014 until May, the company relied on a family physician who was working 10 to 12 hours a day running his own medical practice, according to the report.

Dr. Reuel Gaskins was busy seeing his own patients at the Hampton Medical Clinic in Riverside, Calif., where a red neon sign flashes "Open" in the front window. In an interview, Gaskins said he reviewed cases during breaks throughout the day and after normal work hours. He said he left Agilon in April.

Ultimately, Agilon's internal investigation found that patient care may have been denied 439 times since 2014 without a physician's review of the medical records — a potential violation of state law. Under California law, only a licensed physician or health care professional who is "competent to evaluate the specific clinical issues involved" can determine medical necessity.

Gaskins said he was not aware of allegations that medical decisions were made without his review until he was interviewed by Agilon's lawyers.

"That's inappropriate and unacceptable," he said. "It really bothered me when I heard about it."

The June report also found that Villa helped alter 20 files at the request of a supervisor in 2014 so her employer could pass an upcoming audit by an insurer.

A "manager told me to do it," Villa said in an interview. "They were so adamant that everything look perfect for the auditors."

A few days after the company's lawyers made that discovery, Agilon sent Villa home on paid leave, the nurse said. She said that when she returned to work in August, she found she had been replaced as denial nurse, and shortly after that, she was fired.

Meanwhile, in recent months, Agilon has mended its relationships with some insurers and won new Medicaid contracts.

Consumer advocates worry that the concerns surrounding Agilon and SynerMed signal a much larger problem in the burgeoning Medicaid managed-care industry.

"These private entities get very little oversight," said Linda Nguy, a policy advocate at the Western Center on Law & Poverty in Sacramento, "and there's real harm being done to patients."