Treating Domestic Violence As A Medical Problem

KFF Health News, January 29, 2018

More doctors now screen their patients for signs of abuse and more agencies place victims' advocates inside health centers. Education and counseling for people experiencing violence is also more widely available in clinics and hospitals.

This article first appeared January 29, 2018 on Kaiser Health News.

By Anna Gorman

Fanny Ortiz, a mother of five who lives just east of downtown Los Angeles, spent nearly a decade married to a man who controlled her and frequently threatened her. Then, she said, his abuse escalated. “He would physically hit me in the face, throw me on the wall,” she recalled.

Ortiz, 43, eventually left the marriage, taking her children with her. A few years later, she learned that the East Los Angeles Women’s Center offered domestic violence services at the Los Angeles County-USC Medical Center, near her home. Now she goes to the hospital campus for weekly therapy sessions, which she said have helped stop her suicidal thoughts.

“I was afraid to talk,” Ortiz said. “Now I am more open to talk about things that I was holding in.”

Nearly 1 in 4 women have experienced serious physical violence at the hands of a partner. They often end up in the emergency room or the doctor’s office. But they don’t typically volunteer the reason for their injuries, and doctors don’t always ask about abuse in the home. That failure of communication means the patients may miss out on the help they need.

Yet a growing number of health providers and anti-abuse agencies in California and around the country are collaborating to identify victims and get them help. More doctors now screen their patients for signs of abuse and more agencies place victims’ advocates inside health centers. Education and counseling for people experiencing violence is also more widely available in clinics and hospitals.

About four years ago, the East Los Angeles Women’s Center opened offices on the campus of L.A. County-USC, a busy public hospital. Since then, center staff members have trained more than 2,500 doctors, nurses, social workers and others to identify victims of domestic violence. They also respond quickly to calls from the medical center’s emergency room, inpatient hospital and outpatient facilities to help patients in crisis.

Today, the women’s center has embarked on an innovative approach: In February, it plans to open a short-term shelter for abuse victims on the medical center grounds. The 10-bed shelter fills a serious need, said Deirdre Anglin, an emergency room physician at L.A. County-USC.

“We sometimes have patients in the emergency department who don’t have a place to go, and in the evenings and nights all the shelters in L.A. will be filled,” Anglin said.

Victims of abuse can suffer long-term health problems, including chronic pain, frequent headaches, depression, diabetes and asthma. And they have higher health costs than people who have not experienced abuse. So “it makes complete sense to have the health care providers acting as allies and partners in treating domestic violence,” said Peter Long, CEO of the Blue Shield of California Foundation. (The foundation provides support for Kaiser Health News coverage in California.)

The foundation has funded 19 partnerships between health centers and domestic violence agencies around the state, including the L.A. County-USC office of the East Los Angeles Women’s Center. Similar partnerships operate in Illinois, Maryland and other states.

Last year, the East Los Angeles Women’s Center served 600 victims of domestic violence at the L.A. County-USC hospital campus. Nearly one-third were homeless or couldn’t go back home for safety reasons.

Advocates say that hospitals and clinics are ideal settings to respond to the needs of abused women.

The East Los Angeles Women’s Center is opening a domestic violence shelter on the Los Angeles County-USC Medical Center campus. The proximity makes it easier for doctors to ask patients about violence, said Rebeca Melendez, director of wellness at the center’s hospital office. “They don’t need to know all the answers,” she says. “They just need to call us.” (Anna Gorman/KHN)

In the San Gabriel Valley, the YWCA sponsors domestic violence support groups at a community clinic, while the clinic offers health education for survivors of abuse at the YWCA. In Sacramento, a Native American health center works closely with a domestic violence group a few blocks away.

Doctors have an “unprecedented opportunity to promote prevention and to respond because they are seeing patients that may not ever reach out to a domestic violence agency or police for help,” said Lisa James, director of health for Futures Without Violence, which runs a national resource center dedicated to improving the response of medical professionals to domestic violence. “They can provide this critical lifesaving intervention.”

The proximity of the East Los Angeles Women’s Center to the hospital and clinic buildings on the L.A. County-USC campus makes it easier for doctors to ask their patients about violence, said Rebeca Melendez, director of programs for the center’s office at the medical center. The medical providers know where to turn for guidance – and that the help is nearby.

“They don’t need to know all the answers,” she said. “They just need to call us.”

This growing collaboration between the medical profession and anti-abuse agencies is driven in part by the Affordable Care Act, which requires that health plans cover domestic violence screening and counseling.

The U.S. Preventive Services Task Force recommends doctors routinely question women about violence in the home and refer them to services if needed. The task force concluded in 2013 that intervention could reduce violence and abuse as well as mental and physical health problems.

Organizations such as the American Congress of Obstetricians and Gynecologists and the American Medical Association also recommend routine screening and counseling for domestic violence.

In the past, patients would go to health centers with such problems, but providers did not feel comfortable asking questions about abuse at home, said Long, of the Blue Shield of California Foundation.

“They didn’t feel they had the time and they didn’t feel they had the resources to do something about it,” he said. Nor did they always have a place to send patients who were abuse victims.

Treating patients who are in abusive relationships is “very challenging,” said Anglin, the ER physician. “There is no pill to give.” But asking about violence needs to be part of a physician’s job, she said.

“Part of what we need to do is try to identify patients who may be in a dangerous situation … so we are not just sending these patients back to the same situation they were in only to come back worse off another time.”

Death In The Family: An Uncle's Overdose Spurs Medicaid Official To Change Course

KFF Health News, January 29, 2018

Hampered by political ideology from the White House that has spurred a focus on overhauling Medicaid benefits, for instance, Medicaid's former CMO says CMS is 'ill-equipped' right now to handle the opioid epidemic.

This article first appeared January 29, 2018 on Kaiser Health News.

By Emmarie Huetteman

Andrey Ostrovsky’s family did not discuss what killed his uncle. He was young, not quite two weeks past his 45th birthday, when he died, and he had lost touch with loved ones in his final months. Ostrovsky speculated he had committed suicide.

Almost two years later, Ostrovsky was Medicaid’s chief medical officer, grappling with an opioid crisis that kills about 115 Americans each day, when he learned the truth: His uncle died of a drug overdose.

His family knew the uncle’s life had been turbulent for a while before his death, watching as he divorced his wife and became estranged from his 4-year-old daughter and eventually lost his job as a furniture store manager. But Ostrovsky wanted to understand what happened to his uncle, his stepfather’s younger brother. So, last fall when he found himself in southeastern Florida, where his uncle died in 2015, he contacted one of his uncle’s friends for what he thought would be a quick cup of coffee.

Instead the friend “let loose,” revealing that they had been experimenting with a variety of drugs the night his uncle died — the tragic culmination of more than a decade of substance abuse much of his family knew nothing about. An autopsy showed there were opiates and cocaine in his system, Ostrovsky later learned.

The revelation shook Ostrovsky, a pediatrician appointed to the Centers for Medicare & Medicaid Services in 2016. He had championed better drug treatment programs for the 74 million people on Medicaid — an increasingly uphill battle after Republicans signaled they would trim the program under President Donald Trump.

Within his own agency, Ostrovsky already felt that he was something of a pariah. After he’d posted a tweet against a Republican plan to repeal and replace the Affordable Care Act, he was reprimanded and removed from his major projects. A conservative group known as America Rising filed a Freedom of Information Act request for his email correspondence, a move seen as an attempt to intimidate Ostrovsky.

But that revelation over coffee in Florida made the drug crisis deeply personal for Ostrovsky and his family, prompting him to act. He realized that solutions were not just about money, but also about combating stigma, that stain he says prevented his uncle from getting help. So, he quit his government job last month and is speaking publicly about his family’s experience, to remove the shame of drug addiction.

“It’s not what killed him,” Ostrovsky says, referring to the stigma. “But that’s what killed him.”

Last fall, the Trump administration declared the opioid crisis a public health emergency, stopping short of allocating more funding for an “epidemic” that killed more than 42,000 in 2016 — more than any year on record, according to the Centers for Disease Control and Prevention. That declaration was extended last week. Early data indicate 2017 may have outpaced 2016 in drug deaths.

In one of the latest attempts to manage the crisis, Democratic Gov. Tom Wolf of Pennsylvania recently declared the opioid epidemic a statewide disaster emergency. For the first time, Pennsylvania officials will direct emergency resources toward a public health crisis in the same way they would a natural disaster.

The uncle’s story offers an intimate look at a crisis that has vexed officials on the local, state and national level, strained public health resources — and infiltrated not just America’s streets and drug dens, but also workplaces and successful middle-class families like Ostrovsky’s. KHN agreed not to disclose the uncle’s name out of respect for his family’s privacy.

The uncle immigrated to the United States from Azerbaijan when he was 16, seeking a brighter future than the one stretched before him in the crumbling Soviet Union, Ostrovsky recalled. His family settled in Baltimore, where he married and started his own family. When he wasn’t working, he grilled lamb kebabs and danced to music from his home country. He was a warm, welcoming host, insisting guests have at least a cup of tea.

“Even when he had nothing, he would take that last piece of bread and offer it to you,” Ostrovsky says.

Andrey Ostrovsky (Courtesy of Andrey Ostrovsky)

To Ostrovsky, he was the “cool uncle,” always bringing his nephew trinkets from his travels. When Ostrovsky was in seventh grade, his uncle returned from Jamaica with a shirt that read: “See no evil, hear no evil, speak no evil, s— happens mon.” Ostrovsky wore it to school — and happily suffered the inevitable punishment. “I love him for that and was proud to get in trouble,” he wrote in an email.

Sometime around the early 2000s, the uncle and his wife divorced. He began drinking more, a vice Ostrovsky attributed in part to his cultural heritage but that he suspects grew into alcoholism.

It is unclear to the family when, exactly, drugs came into his life, though his problems seem to have escalated in his 30s. His drug of choice was cocaine, Ostrovsky learned from his uncle’s friend, who frequently took drugs with him over the years.

His inability to function at work and other financial strains eventually drove him to crack cocaine, an especially addictive, cheaper form that produces an instant, intense high when smoked. Months before his death, he lost his job and grew depressed. He began using more heavily and trying new drugs. He dabbled in benzodiazepines, a class of psychoactive drugs like Xanax and Valium, and opioids.

Opioids, which broadly include both illegal drugs like heroin and prescription painkillers like OxyContin, are particularly perilous when misused because they suppress the ability to breathe. Those who use opioids also build up a tolerance over time, encouraging them to use more to achieve a high. These facts are especially problematic considering street drugs are often cut with more powerful opioids — such as fentanyl, a fast-acting painkiller — to create a more intense high.

Eventually, Ostrovsky’s uncle began living with his drug dealer. On the night of his death, he and his friend went through the dealer’s stash when he was out, trying pills and other drugs. When the dealer returned, after the friend had left, the uncle didn’t answer the door.

They found him on the couch, looking “at peace,” his friend recounted to Ostrovsky. They tried to resuscitate him and called for help. Sitting on the curb outside, his friend watched the paramedics carry him away.

The friend says he quit using drugs and is enrolled in a methadone program, a treatment option that uses another opioid to reduce withdrawal symptoms.

Hampered by political ideology from the White House that has spurred a focus on overhauling Medicaid benefits, for instance, Ostrovsky says his former agency, CMS, is “ill-equipped” right now to handle this problem. So, for now, he’s working outside the government.

This month, Ostrovsky announced he is joining Concerted Care Group, an addiction treatment program based in Baltimore whose patients are mostly covered by Medicaid, where he will serve as CEO as the organization looks to expand.

Ostrovsky first noticed Concerted Care Group when it was part of a CMS pilot program, a standout because it eschewed the surreptitious-feeling grab-and-go approach of most outpatient addiction centers. “This can’t be a methadone clinic,” Ostrovsky thought when he first heard about it.

It offered patients private spaces to take their medicine; security guards to ensure their safety; even coffee while they wait, preserving at least a modicum of patient dignity. In the same spirit, Ostrovsky hopes that sharing his personal story about his uncle will combat the stigma that makes patients and their loved ones ashamed to reach out for help.

“I think this is really important, that people hear about his story and talk,” he says, “and get over that feeling of not wanting to have that uncomfortable conversation with my family member who needs help.”

Big Pharma Greets Hundreds Of Ex-Federal Workers At the 'Revolving Door'

KFF Health News, January 25, 2018

Former congressional staffers who now work for drug companies often return to the Hill to lobby former co-workers or employees. This raises concerns that pharmaceutical companies could wield undue influence.

This article first appeared January 25, 2018 on Kaiser Health News.

By Sydney Lupkin

Alex Azar’s job hop from drugmaker Eli Lilly to the Trump administration reflects ever-deepening ties between the pharmaceutical industry and the federal government.

A Kaiser Health News analysis shows that hundreds of people have glided through the “revolving door” that connects the drug industry to Capitol Hill and to the Department of Health and Human Services.

Azar was confirmed Wednesday as HHS secretary, joining other former drug industry alumni in top positions.

Nearly 340 former congressional staffers now work for pharmaceutical companies or their lobbying firms, according to data analyzed by KHN and provided by Legistorm, a nonpartisan congressional research company. On the flip side, the analysis showed, more than a dozen former drug industry employees now have jobs on Capitol Hill — often on committees that handle health care policy.

“Who do they really work for?” said Jock Friedly, Legistorm’s president and founder, who called that quantity “substantial.” “Are they working for the person who is paying their bills at that moment or are they essentially working on behalf of the interests who have funded them in the past and may fund them in the future?”

In many cases, former congressional staffers who now work for drug companies return to the Hill to lobby former co-workers or employees. The deep ties raise concerns that pharmaceutical companies could wield undue influence over drug-related legislation or government policy.

“You’ll take the call because you’ve got a friendly relationship,” said Diana Zuckerman, president of the nonprofit National Center for Health Research and a former congressional staffer. “You’ll take the call because these people are going to help you in your future career [and] get you a job making three times as much.”

A 2012 Sunlight Foundation investigation found that, on average, a chief of staff on the Hill could increase his or her salary 40 percent by moving to the private sector.

Experts say the cozy relationships don’t necessarily mean congressional staffers do favors for lobbyists they know, but the access doesn’t hurt.

When John Stone left the House Energy and Commerce Committee last fall to join lobbying firm BGR, he told Politico that he had consulted with two lobbyists at BGR “for advice on basically everything that came across my desk.”

KHN’s review of Legistorm data indicates that one of the lobbyists, BGR’s Ryan Long, overlapped with Stone on the House panel. Brent Del Monte preceded them both on the committee and then spent 10 years at the Biotechnology Innovation Organization (BIO), a trade group for the biologic drug industry, before joining BGR in 2015. BGR’s clients include PhRMA, Celgene and other pharmaceutical firms.

Like Stone, Long and Del Monte, many ex-Hill staffers working in some way for the pharmaceutical industry came from key committees, including the Senate Committee on Health, Education, Labor and Pensions (HELP) and the House Energy and Commerce Committee, which in 2016 shepherded the 21st Century Cures Act into law. The law faced criticism from watchdogs who feared it would make drug approval cheaper and easier but could lead to unsafe approvals.

Tim LaPira, a James Madison University associate professor who co-authored a book about the revolving door published in June, said the practice of leaving government service to lobby for industry isn’t as corrupt as it seems. Rather, as congressional staffs have shrunk over time, they’ve been forced to essentially outsource expertise to lobbyists, he said.

“Don’t tell the private sector to stop doing it. Tell Congress to stop relying on the private sector so much,” LaPira said, adding that Congress spends just 0.5 percent of the discretionary budget on itself.

The number of congressional employees declined by more than 7,000 people — about 27 percent — from 1979 to 2015, according to data compiled by the Brookings Institution, a nonprofit research group.

While there’s a fear that lobbyists are slipping industry-friendly language into legislation, LaPira explained, more often they’re monitoring what’s happening inside government.

The reverse-revolving door, in which former pharmaceutical employees enter public service, is not as clearly understood. Neither is the flow of serial revolvers, who go from industry to government and back.

Some of those Hill staffers, according to financial disclosures, maintain drug industry pensions and stock, Kaiser Health News found. They are not required to divest and are required to disclose those connections only if they hold key positions.

Reverse revolvers may not realize they’re doing Big Pharma’s bidding, Friedly said, but they’ve been so exposed to the industry’s point of view that their implicit biases may seep into their legislative work.

The revolving door operates beyond the Hill, however, LaPira said

In addition to Azar, several former drug industry officials have landed key jobs in Trump’s Cabinet and administration, including Food and Drug Administration Commissioner Scott Gottlieb, a former venture capitalist with deep ties to the pharmaceutical industry.

Gottlieb disclosed serving on boards of several pharmaceutical companies, including GlaxoSmithKline and Daiichi Sankyo, prior to returning to government for his third trip through the revolving door.

KHN also reviewed the résumés of more than 100 HHS appointees, obtained via a Freedom of Information Act request by American Oversight, a nonprofit founded to hold government officials accountable. Although only a handful of recent appointees were employed directly by drug companies, more than a dozen had worked as lobbyists, consultants and lawyers on behalf of pharmaceutical firms.

The high-level HHS appointees include: Keagan Lenihan, a former lobbyist for drug distributor McKesson who now serves as senior counselor to the secretary at HHS; former PhRMA lobbyist John O’Brien, now deputy assistant secretary of health policy for the agency’s Planning and Evaluation arm; and former Bristol-Myers Squibb lobbyist Mary-Sumpter Lapinski, an attorney in the HHS secretary’s office.

Sen. Elizabeth Warren expressed concerns about the revolving door during Azar’s confirmation hearing before the HELP committee in November. Not long after telling Azar that his “résumé reads like a how-to manual for profiting from government service,” she asked him whether drug industry CEOs should be held accountable when the companies they run break the law. He did not answer yes or no.

His reply: “I’m satisfied with our discussion.”

METHODOLOGY

Kaiser Health News obtained revolving-door and lobbying disclosure data from Legistorm, a for-profit, nonpartisan congressional research firm based in Washington, D.C.

The revolving-door data include congressional staffers’ jobs on and off Capitol Hill. It is current through August 2017 and dates to 2001. For lobbyists who did not directly work for pharmaceutical firms but worked for lobbying firms on behalf of pharmaceutical companies and their trade groups, Kaiser Health News used lobbying disclosure data to identify individuals registered to lobby on behalf of these clients. Reporters then tracked down these lobbyists in Legistorm’s revolving door data and checked them by hand.

The HHS appointee résumés obtained by American Oversight covered individuals appointed from Jan. 20 to July 12, 2017.

Hospitals' Best-Laid Plans Upended By Disaster

KFF Health News, January 24, 2018

An unusual number of calamities plagued America's hospitals in 2017: fires in California; hurricanes in Texas, Florida, and Puerto Rico; the deadliest mass shooting in modern history; and even attacks within hospital walls.

This article first appeared January 24, 2018 on Kaiser Health News.

By Ana B. Ibarra

It was 3:35 a.m. and flames from a massive Northern California wildfire licked at the back of a Santa Rosa hospital.

Within three hours, staffers evacuated 122 patients to other facilities — something they’d never come close to doing before. Ambulances sped off with some of the sickest patients; city buses picked up many of the rest.

With phone lines charred and communication restricted, doctors and nurses struggled to figure out who was sent where — forced to keep their wits even as some of their own homes burned and their families fled.

This was not exactly covered in their meticulously executed drills and disaster-preparedness videos.

“You never know how you’ll react until it comes your way … until fate taps you on the shoulder,” said Dr. Josh Weil, an emergency medicine physician at Kaiser Permanente in Santa Rosa who led the hospital evacuation operation on Oct. 9.

America’s hospitals were beset by an unusual number of calamities in 2017: The fires that raged in Northern and Southern California; hurricanes that displaced thousands in Houston, Florida and Puerto Rico; the deadliest mass shooting in modern history that killed 58 people and wounded more than 500 others in Las Vegas; and the attack at a Bronx hospital in which a doctor turned a gun on his former colleagues, killing one and injuring six.

Across the country, natural disasters have become more frequent and more deadly; the carnage from mass shootings resembles that on a battlefield. In some cases, these crises are more severe and elaborate than most hospitals — particularly smaller ones — are prepared for, and experts say it is time to bring facilities up to speed.

“The probability that any individual hospital will be involved in an unusual event is increasing,” said Dr. Carl Schultz, professor emeritus of emergency medicine and public health at the University of California-Irvine. “All hospitals are potentially vulnerable,” he said, and “there is more pressure for hospitals to be prepared.”

That’s the case, he added, even though hospitals often lack the resources and funding to upgrade their disaster plans.

In the new year, hospitals that responded to outsized tragedies in 2017 are reassessing their plans in light of their painful experiences. Below are some instructive examples:

Keeping Track Of Patients

In Northern California, staffers from the Kaiser hospital in Santa Rosa rushed to clear out their wards as the ferocious Tubbs Fire approached. (Kaiser Health News, which produces California Healthline, is not affiliated with Kaiser Permanente.)

The original plan was to jot down details from each displaced patient’s identification bracelet so that the hospital could later confirm that patients arrived at other hospitals safely. But with the fire coming fast upon them, it became clear this would take too long, Weil said.

On the fly, one staffer suggested taking photos of patient wristbands with smartphones, he said.

“That was a brilliant idea that really saved us,” Weil said.

The hospital is now considering whether smartphones might be of greater use in future emergencies, or if there’s a more efficient way to track patients who must be rapidly whisked away.

Eight days earlier, another tracking issue surfaced at Sunrise Hospital & Medical Center in Las Vegas — this one concerning incoming patients. The facility was suddenly inundated by people shot or otherwise injured during the tragedy at the outdoor country music festival; 212 patients were admitted in a two-hour window, 124 of them with gunshot wounds.

Of those, 92 had no official photo identification on them.

Families dashed desperately from one hospital to another searching for their loved ones, said Alan Keesee, the hospital’s chief operations officer. Without IDs for patients, it was a challenge to confirm whether they were at the hospital, let alone whether they would be OK.

Enterprising staffers listed their unidentified patients’ physical traits and unique features, such as tattoos, to help match people with the descriptions family members provided. In turn, many relatives pulled up social media profile photos of their loved ones to give the hospital something to go by.

The chaotic process of patient identification exposed a desperate need for a centralized data hub where descriptions of unidentified patients in a massive emergency could be uploaded and accessed by all area hospitals, Keesee said.

And indeed, he said, his hospital is working with the Nevada Hospital Association and other local health agencies to determine whether the hub can be created.

Communication And Coordination

Last June, a former doctor stormed Bronx-Lebanon Hospital armed with a semiautomatic rifle.

Staff members had trained for just this kind of incident. But they had not anticipated how restricted their movements would be once police took over, said Dr. Sridhar Chilimuri, the physician-in-chief that day.

“Shooting victims need blood transfusions, so you need to get from the blood bank to the operating rooms quickly,” Chilimuri said.

But the hospital lockdown blocked access to elevators. Doctors and nurses also had to fetch surgical instruments and move patients, he added, but they couldn’t do so without approval from police.

Because it was an internal shooting, police had to clear staffers of suspicion before they could return to work — even the doctors needed for lifesaving operations.

The hospital has since updated its drills to include an accelerated process of police screening — targeting the medical staff most urgently needed — and its training videos now show an attacker armed with an assault weapon rather than a small handgun.

“Hopefully that will help us cut down on the time we are crippled,” Chilimuri said.

Running Low On Supplies

When Hurricane Irma barreled into South Florida in September, the 10 Tenet Health hospitals in the region felt ready.

They had beefed up their disaster plans after Hurricane Matthew landed a year earlier, said Cathy Philpott, a director of nursing practice and clinical operation for the hospital system. They also brought in staff from other states and rolled in backup generators, she said.

Even so, they faced an unexpected challenge: a shortage of platelets, cells that help the body form clots to stop bleeding.

Until sister hospitals in Boston could airlift platelets in, the hospitals had to work with local blood banks to conserve the supply and prioritize their use for trauma patients. When hurricanes are forecast in the future, the hospitals will reach out to local blood banks and host platelet drives as the storms approach, Philpott said.

“That’s the lesson learned,” she said.

States Face Costly Conundrum: How To Treat Inmates With Hepatitis C

KFF Health News, January 23, 2018

While the disease is common among the incarcerated, treatment with the latest hepatitis drugs isn't.

This article first appeared January 23, 2018 on Kaiser Health News.

By Alex Smith, KCUR

In a corner of Jymie Jimerson's house in the town of Sparta, in southwestern Missouri, she has set up a kind of shrine. It has Native American art representing her Cherokee heritage alongside Willie Nelson albums, books and photos in remembrance of her late husband.

There's a copy of Nelson's mid-'70s LP "Red Headed Stranger."

"When Steve was young, he had red hair and a red beard, so he always really identified with Willie's ‘Red Headed Stranger,'" Jimerson said. "I try to keep it up there as a reminder of better days."

Her husband, Steve Jimerson, was sentenced to life in prison in 1996 for his role in the shooting deaths of two men. Jimerson said her husband's life had been ravaged by drug abuse. But after he entered prison, he got off drugs and become a mentor for other inmates.

"Once he got inside, recovery became his life," Jimerson said. "And that was his passion until the day he died."

Steve Jimerson died on Jan. 6, 2017, of complications from hepatitis C, a liver infection that's especially widespread among prison inmates. He was 59.

While the disease is common among the incarcerated, treatment with the latest hepatitis drugs isn't.

Civil liberties groups in Missouri and at least seven other states are now suing to get more inmates treated with new-generation hepatitis C drugs that are highly effective but also costly.

After Steve Jimerson was diagnosed with hepatitis C in prison, his widow said, he was on the lookout for news of treatment advances.

In 2013, Gilead Sciences introduced Sovaldi, the first of a new generation of drugs called direct-acting antivirals that can cure hepatitis C and with fewer side effects than the previous treatments. But the excitement was dampened by the drug's price. A full course of treatment carried an $84,000 price tag.

In 2016, around 5,000 inmates in Missouri's prisons had hepatitis C, and no more than 14 of them received the drugs, according to internal state data obtained by the Roderick & Solange MacArthur Justice Center in St. Louis. That's about 15 percent of the 32,000 people incarcerated in Missouri's prisons.

Jimerson said that her husband wasn't given direct-acting antivirals. By the fall of 2016, his health was deteriorating rapidly, and he grew pessimistic about the prospects for a cure.

"He told me that if someone had to die to get the DOC [Department of Corrections] to change their policy, he was OK with it being him," she said.

As recently as 2012, scores of Missouri inmates were being treated with older hepatitis C drugs, including one called interferon that is notorious for its debilitating side effects. But in 2013, the Federal Bureau of Prisons started changing treatment guidelines to replace the old hepatitis C drugs with new ones.

Many states follow those guidelines, including Missouri, according to a spokesperson from Corizon Health, the private company that provides health care for Missouri's inmates.

But the updated guidelines gave prisons more leeway to decide when it's appropriate to provide treatment. And as Missouri phased out the old drugs, it hasn't used the new drugs nearly as often. That has left only a handful of inmates getting any hepatitis C drug treatment at all.

In December 2016, the American Civil Liberties Union and MacArthur Justice Center sued to get the Missouri Department of Corrections to provide direct-acting antiviral drugs to inmates with hepatitis C who qualify for treatment.

ACLU lawyer Tony Rothert said the state's current treatment practices violate the U.S. Constitution's Cruel and Unusual Punishments Clause, part of the Eighth Amendment.

"The Supreme Court has said that in the context of medical care, that means that prisons cannot be deliberately indifferent to serious medical needs," Rothert said. "Hepatitis C fairly easily satisfies this test, because if left untreated, there's a fair chance that you will die."

Advocates making this argument got a big boost for their case in November 2017, when a federal judge in Florida ordered that state's prisons start providing direct-acting drugs to its inmates at least until that state's case goes to trial in August.

"It was a great victory for people who are incarcerated and have hepatitis C because now we have a federal judge who said, ‘Look, this is just unconscionable,' and the state is going to have to do something about it," said Elizabeth Paukstis, public policy director of the National Viral Hepatitis Roundtable.

In July 2017, the Missouri lawsuit took a leap forward when the judge overseeing the case certified it as a class action on behalf of state inmates with hepatitis C. The Missouri Department of Corrections and Corizon, which are defendants in the lawsuit, have appealed that ruling.

Both the Missouri Department of Corrections and Corizon declined to comment on the suit or answer questions about their hepatitis C treatment protocols beyond saying they are following federal guidelines.

But if Missouri and other states are required to offer the new drugs, they would face a huge problem, said Gregg Gonsalves, an assistant professor of epidemiology at the Yale School of Public Health. "Even if they wanted to treat patients, they would break the bank. They would run out of money to treat every other medical condition," he said.

For example, if Missouri gave the 2,500 inmates that the ACLU says are candidates for Harvoni, the direct-acting antiviral drug it now uses, the cost would exceed $236 million, based on its list price. That far exceeds the Department of Corrections' entire budget for inmate health.

Gonsalves said the emergence of newer, cheaper drugs could help, and some state prison systems have managed to negotiate discounts.

Even at a lower cost, though, providing these drugs on a large scale could still cost states a fortune. But advocates insist it's worth it to stop the disease from spreading. And a 2015 study showed that as many as 12,000 lives would be saved if inmates across the country were screened and treated; preventing liver transplants and liver disease would save money in the long run.

"The impetus for treating infectious disease in the prison system is that it's a population you can reach, it's a population you can cure, and it's a population you can help prevent onward infections from," Gonsalves said.

Jymie Jimerson understands that many people might be skeptical about providing expensive health care for prison inmates. But she hopes they can see them as more than people convicted of crimes, she said.

"I'm not condoning what they did. I'm not condoning criminals," Jimerson said. "What I'm saying is, they're human beings. And there are hundreds, hundreds of first-time offenders that this medication would cure them. So that when they went home, they could actually spend time and enjoy a little bit of life with their families."

It's In The Mail: Aetna Agrees To $17M Payout In HIV Privacy Breach

KFF Health News, January 19, 2018

The insurer also said it is 'implementing measures designed to ensure something like this does not happen again as part of our commitment to best practices in protecting sensitive health information.'

This article first appeared January 18, 2018 on Kaiser Health News.

By Elana Gordon, WHYY

Aetna settled a lawsuit for $17 million Wednesday over a data breach that happened in the summer of 2017. The privacy of as many as 12,000 people insured by Aetna was compromised in a very low-tech way: The fact that they had been taking HIV drugs was revealed through the clear window of the envelope.

"I was shocked," said Sam, who distinctly recalls the day he received the notice in August. (Kaiser Health News and NPR agreed not to use his full name because he worries about how going public with his HIV status might affect his work.) The letter came to his mailbox in an apartment complex in New Jersey. He wasn't directly involved in the lawsuit but says the letter hit a level of vulnerability he had never felt before.

"I haven't disclosed my HIV status to my parents," said Sam, 36, who is a civil rights attorney. "Let's say that letter had gotten forwarded to their house and someone happened to open the mail. Those were the types of things going through my mind."

In a statement, Aetna wrote: "Through our outreach efforts, immediate relief program and this settlement we have worked to address the potential impact to members following this unfortunate incident."

The insurer also said it is "implementing measures designed to ensure something like this does not happen again as part of our commitment to best practices in protecting sensitive health information."

In an ironic twist, the letters were sent in response to a settlement over previous privacy violation concerns. Aetna had required members to obtain HIV medications through mail-order pharmacies. The affected people had taken medication to treat HIV or to lower the risk of becoming infected with the virus, an approach called PrEP, or pre-exposure prophylaxis.

Lawsuits filed in 2014 and 2015 alleged that policy was discriminatory, that it prevented patients taking HIV medicine from receiving in-person counseling from a pharmacist and that it jeopardized members' privacy.

Aetna settled with the individual plaintiffs, changed its policy to allow members to fill HIV prescriptions in person at retail pharmacies, and, in turn, sent out notification letters to anyone who had filled prescriptions for HIV medications.

It was those notification letters that contained a large envelope window that exposed sensitive HIV information.

While the stigma surrounding HIV may be less severe than it used to be and treatments have improved greatly, Ronda Goldfein, director of the AIDS Law Project of Pennsylvania, said the reality is that serious discrimination still exists. That means protecting patient confidentiality is critical to ensuring people feel safe getting care.

As hundreds of calls from people who received the Aetna letter started coming into Goldfein's office and others around the country, she learned of more harrowing and devastating experiences. She said she heard from one man who had homophobic slurs painted on his door when neighbors saw the letter. Other letter recipients felt the need to move out of their neighborhoods. For one woman, whose status became known in her tight-knit immigrant community, "she stopped being able to function, she stopped being able to go to work, and she lost her job," Goldfein said.

The AIDS Law Project of Pennsylvania and the Legal Action Center initially issued a demand letter in late August that the insurer stop the mailings. The company responded, setting up a relief fund for affected people and apologizing. "This type of mistake is unacceptable, and we are undertaking a full review of our processes to ensure something like this never happens again," the health insurer said.

Goldfein and others soon discovered that the mailing was more widespread than first thought: Up to 12,000 people had received it. Her agency, the Legal Action Center and Berger & Montague PC filed a lawsuit and sought class-action status.

The privacy breach as outlined in the proposed settlement was twofold: Aetna released the names of 13,480 people to its legal counsel and a vendor without proper authorization. Of those, 11,875 got the letter that revealed they were taking HIV medication.

The proposed settlement is awaiting approval in federal court, but in it Aetna has agreed to pay $17 million and set up new "best practices" to prevent something like this from happening again.

As part of the payout, the law firms are setting aside at least $12 million for payments of at least $500 to the estimated 11,875 people who may have received a letter exposing that information, acknowledging that "the harm was in the status being disclosed," Goldfein said. Plus, people won't have to file additional paperwork and go through more mailings pertaining to their HIV medications.

A fund will be set up for those who experienced additional financial or emotional distress. Individuals will be able to claim up to $20,000. The rest of the money will go toward legal fees and costs.

"It's a much bigger settlement than ordinary identity theft scenarios, where an online database has been breached and the main injury people are claiming is that they might be victims of identity theft and maybe have their financial information compromised," said William McGeveran, a specialist in privacy law and data breaches at the University of Minnesota.

The amount may be unusual, but McGeveran also said low-level breaches like this aren't. Companies may be so focused on IT security that they overlook other ways that privacy can be breached.

"They're more common than people realize," McGeveran said. "There's so much attention to cybersecurity, and rightly so, but a lot of medical privacy concerns are much more analog than that. They're about things being overheard, they're about paper records and in this case it's about a paper mailing."

Beyond the payout itself, she hopes the suit helps change the culture of companies when it comes to the attention paid to medical privacy, and the rights of people with HIV in particular. To highlight that, lawyers used "Andrew Beckett" as the pseudonym for the original plaintiff in the case, a Pennsylvania man from Bucks County.

It's a nod to the Tom Hanks character in the 1993 film "Philadelphia," who was fired after his law firm found out he had HIV. This "Beckett" is taking PrEP.

"HIV still has a negative stigma associated with it, and I am pleased that this encouraging agreement with Aetna shows that HIV-related information warrants special care," the man known as Beckett said in statement.

Home Care Agencies Often Wrongly Deny Medicare Help To The Chronically Ill

KFF Health News, January 18, 2018

Medicare does cover home care services for patients who qualify, but incentives intended to combat fraud and reward high quality care are driving some home health agencies to avoid taking on long-term patients.

This article first appeared January 18, 2018 on Kaiser Health News.

By Susan Jaffe/Photos by Heidi de Marco

Colin Campbell needs help dressing, bathing and moving between his bed and his wheelchair. He has a feeding tube because his partially paralyzed tongue makes swallowing “almost impossible,” he said.

Campbell, 58, spends $4,000 a month on home health care services so he can continue to live in his home just outside Los Angeles. Eight years ago, he was diagnosed with amyotrophic lateral sclerosis, or “Lou Gehrig’s disease,” which relentlessly attacks the nerve cells in his brain and spinal cord and has no cure.

The former computer systems manager has Medicare coverage because of his disability, but no fewer than 14 home health care providers have told him he can’t use it to pay for their services.

Campbell has ALS, which attacks the nerve cells in the brain and the spinal cord. The former computer systems manager uses a walker, wheelchair and built-in fixtures to help him get around. (Heidi de Marco/KHN)

That’s an incorrect but common belief. Medicare does cover home care services for patients who qualify, but incentives intended to combat fraud and reward high quality care are driving some home health agencies to avoid taking on long-term patients such as Campbell, who have debilitating conditions that won’t get better, according to advocates for seniors and the home care industry. Rule changes that took effect this month could make the problem worse.

"We feel Medicare coverage laws are not being enforced and people are not getting the care that they need in order to stay in their homes," said Kathleen Holt, an attorney and associate director of the Center for Medicare Advocacy, a nonprofit, nonpartisan law firm. The group is considering legal action against the government.

Campbell developed drop foot due to his ALS and needs to wear a brace. He relies on help from a home health worker to get dressed and bathed every day. (Heidi de Marco/KHN)

Federal law requires Medicare to pay indefinitely for home care — with no copayments or deductibles — if a doctor ordered it and patients can leave home only with great difficulty. They must need intermittent nursing, physical therapy or other skilled care that only a trained professional can provide. They do not need to show improvement. Those who qualify can also receive an aide’s help with dressing, bathing and other daily activities. The combined services are limited to 35 hours a week.

Medicare affirmed this policy in 2013 when it settled a key lawsuit brought by the Center for Medicare Advocacy and Vermont Legal Aid. In that case, the government agreed that Medicare covers skilled nursing and therapy services — including those delivered at home —to maintain a patient's abilities or to prevent or slow decline. It also agreed to inform providers, bill auditors and others that a patient's improvement is not a condition for coverage.

Campbell said some home health care agencies told him Medicare would pay only for rehabilitation, "with the idea of getting you better and then leaving," he said. They told him that Medicare would not pay them if he didn’t improve, he said. Other agencies told him Medicare simply did not cover home health care.

Medicaid, the federal-state program for low-income adults and families, also covers home health care and other home services, but Campbell doesn’t qualify for it.

Campbell needs to use a ventilator to help him breathe and depends on a home health worker to put it on. (Heidi de Marco/KHN)

Securing Medicare coverage for home health services requires persistence, said John Gillespie, whose mother has gone through five home care agencies since she was diagnosed with ALS in 2014. He successfully appealed Medicare's decision denying coverage, and afterward Medicare paid for his mother’s visiting nurse as well as speech and physical therapy.

"You have to have a good doctor and people who will help fight for you to get the right company," said Gillespie, of Orlando, Fla. "Do not take no for an answer."

Yet a Medicare official did not acknowledge any access problems. "A patient can continue to receive Medicare home health services as long as he/she remains eligible for the benefit," said spokesman Johnathan Monroe.

A home health worker administers meals to Campbell through a feeding tube three times a day. (Heidi de Marco/KHN)

But a leading industry group contends that Medicare’s home health care policies are often misconstrued. “One of the myths in Medicare is that chronically ill individuals are not qualified for coverage," said William Dombi, president of the National Association for Home Care and Hospice, which represents nearly half of the nation’s 12,000 home care providers.

Part of the problem is that some agencies fear they won’t be paid if they take on patients who need their services for a long time, Dombi said. Such cases can attract the attention of Medicare auditors who can deny payments if they believe the patient is not eligible or they suspect billing fraud. Rather than risk not getting paid, some home health agencies “stay under the radar” by taking on fewer Medicare patients who need long-term care, Dombi said.

And they may have a good reason to be concerned. Medicare officials have found that about a third of the agency's payments to home health companies in the fiscal year ending last September were improper.

Campbell's adjustable wheelchair allows him to recline, which makes breathing easier. (Heidi de Marco/KHN)

Shortages of home health aides in some areas might also lead an overburdened agency to focus on those who need care for only a short time, Dombi said.

Another factor that may have a negative effect on chronically ill patients is Medicare’s Home Health Compare ratings website. It includes grades on patient improvement, such as whether a client got better at walking with an agency’s help. That effectively tells agencies who want top ratings “to go to patients who are susceptible to improvement,” Dombi said.

This year, some home care agencies will earn more than just ratings. Under a Medicare pilot program, home health firms in nine states will start receiving payment bonuses for providing good care and those who don't will pay penalties. Some criteria used to measure performance depend on patient improvement, Holt said.

Another new rule, which took effect last Saturday, prohibits agencies from discontinuing services for Medicare and Medicaid patients without a doctor’s order. But that, too, could backfire.

"This is good," Holt said. "But our concern is that some agencies might hesitate to take patients if they don't think they can easily discharge them."

When Food Stamps Pass As Tickets To Better Health

KFF Health News, January 17, 2018

The goal of the four-year program, like that of its counterparts in other states, is to improve diets and overall health by making fresh produce more affordable.

This article first appeared January 17, 2018 on Kaiser Health News.

By Courtney Perkes

Rebeca Gonzalez grew up eating artichokes from her grandmother’s farm in the central Mexican state of Tlaxcala. But for years after emigrating to the U.S., she did not feed them to her own kids because the spiky, fibrous vegetables were too expensive on this side of the border.

When she prepared meals at her family’s home in Garden Grove, Calif., Gonzalez would also omit avocados, a staple of Mexican cuisine that is often costly here.

“I saw the prices and I said, ‘No, never mind,’” said Gonzalez, a 47-year-old child care worker who receives about $500 a month in food stamps.

But those items are no longer out of reach for her family. Since enrolling last year in a program that rewards food stamp beneficiaries for buying more fresh produce, Gonzalez has regularly filled her shopping cart with the fruits and vegetables of her childhood — not only avocados and artichokes, but pomegranates, various types of squash and more.

Participation in the program, called “Más Fresco,” or “More Fresh” in English, gives Gonzalez an additional $40 a month to spend on produce, allowing her to broaden the palates of her three U.S.-born children. “The good thing is my family likes to try the new vegetables,” she said. “Now I can buy them because I have the extra money.”

The University of California-San Diego is administering Más Fresco and studying its results with a $3.4 million grant from the U.S. Department of Agriculture, which has funded similar efforts in other states, including Illinois, Georgia, Pennsylvania, Minnesota and New Mexico. The dollars invested in those states have been aimed at inducing food stamp recipients to buy more produce at farmers markets or at mobile markets that visit low-income neighborhoods.

Más Fresco is open to Southern Californians in Los Angeles, Orange and San Diego counties who are enrolled in the Supplemental Nutrition Assistance Program, or SNAP — the official name for food stamp benefits.

The goal of the four-year program, like that of its counterparts in other states, is to improve diets and overall health by making fresh produce more affordable.

“We know food insecurity and, unfortunately, chronic disease go hand in hand,” said Joe Prickitt, a UC-San Diego dietitian who is senior director of Más Fresco. “For SNAP participants, there’s a real cost barrier to buying fruits and vegetables. They say they’re just too expensive.”

Rebeca Gonzalez holds a copy of her grocery receipt and her Northgate González loyalty card. The loyalty card tracks her purchases and redemptions through Más Fresco, a program that urges food stamp recipients to buy produce. (Courtney Perkes for KHN)

Since Más Fresco began in February 2017, it has enrolled 1,153 participants, who receive an average of $329 a month in food stamps and typically live in households of five or six people. Ninety percent of them are Latinos, but adults from any ethnic background can join provided they are willing to shop at a participating Northgate González Market – an Anaheim, Calif.-based Latino grocery chain that is Más Fresco’s retail partner.

For every dollar worth of food stamps enrollees spend on fresh produce in a given month, they receive a one-to-one match, up to $10, $20 or $40, which they can spend only on more fruits and vegetables. The UC-San Diego researchers who are studying the program varied the maximum reward amounts and assigned them randomly to participants to help determine the optimal dollar level for changing people’s dietary habits.

The six participating Northgate stores — two in each of the three participating counties — use loyalty cards to tally produce purchases and distribute the credits. The amount of credit participants have earned and redeemed is itemized at the bottom of their receipts, and the credit carries over from month to month.

Research has shown that affordability is an obstacle to healthier eating for people of modest means. A 2013 study by researchers at Harvard and Brown universities estimated that a healthful diet costs about $550 a year more per person than an unhealthy one. “For many low-income families, this additional cost represents a genuine barrier to healthier eating,” the authors concluded. “Yet, this daily price difference is trivial in comparison with the lifetime personal and societal financial burdens of diet-related chronic diseases.”

A 2016 report by the U.S. Department of Agriculture revealed that food stamp recipients spend a smaller percentage of their grocery budgets on fruits and vegetables than other Americans do.

Financial incentives like the ones being tested in California can help narrow that gap.

A 2011 study of an incentive program in Massachusetts found that people on food stamps who got an extra 30 cents for every dollar they spent on fruits and vegetables consumed nearly a quarter-cup, or 26 percent, more fresh produce per day than recipients who did not get such an incentive.

Last week, Más Fresco began to enroll a second round of up to 2,000 people who will receive the incentive for one year. The current participants will continue in the program through June.

Prickitt said he hopes that even after their financial incentives end, participants will retain what they have learned about healthy eating and continue buying produce.

Rebeca Gonzalez says she can now afford pomegranates for her family because of the extra money she receives through Más Fresco, an incentive program for purchasing produce. (Courtney Perkes for KHN)

Food policy experts note that many other factors can influence a family’s food choices, including lack of time.

“If parents are working more than one job or children are in more than one school or activity, how do you teach the skills of how you can prepare food, even on a busy weeknight?” said Dean Sidelinger, a pediatrician and child health medical officer for San Diego County.

Some advocates for healthful diets have argued that government should not only encourage people to buy healthier food but also discourage unhealthful habits.

A 2014 Health Affairs study by Stanford University researchers showed that banning the purchase of soda with food stamps would reduce rates of obesity and diabetes, while a credit of 30 cents on the dollar for buying fresh produce alone would not.

In 2017, more than a dozen researchers from different universities urged SNAP to eliminate diet-related health disparities among programs for low-income people. They noted, for example, that the federal food-assistance program known as Women, Infants and Children, or WIC, excluded soda and candy but that people could still buy those products with food stamps.

“There are generations of unhealthy people who are overweight with diabetes and hypertension,” said Jim Floros, president and CEO of the San Diego Food Bank, which has advertised the Más Fresco program to its clients. “That’s completely linked back to a poor diet, which is linked back to poverty.”

Rebeca Gonzalez, who moved to the U.S. at age 18, decided to overhaul her family’s eating habits after her husband, Javier Landeros, was diagnosed with diabetes two years ago. Instead of buying cookies, she now keeps chopped fruits and veggies in the fridge for snacks.

She said she wants to instill the same healthy habits her grandmother passed on to her.

“I know she gave us good food,” Gonzalez said, “because she lived 105 years.”

In Wisconsin, Hopes Rise For Production Of A Lifesaving Radioactive Isotope

KFF Health News, January 16, 2018

Delays that pose an inconvenience for other commercial goods are existential threats in the daily global relay race of medical isotopes that disappear hour by hour.

This article first appeared January 16, 2018 on Kaiser Health News.

By Sarah Varney

JANESVILLE, Wis. — In a cornfield here, past the shuttered General Motors plant and the Janesville Terrace trailer home park, a facility not seen in the United States in three decades could soon rise: a manufacturing plant that will make a vital radioactive isotope used to detect cancer and other potentially fatal maladies in millions of people every year.

Nuclear medicine imaging, a staple of American health care since the 1970s, runs almost entirely on molybdenum-99, a radioisotope produced by nuclear fission of enriched uranium that decays so rapidly it becomes worthless within days. But moly-99, as it’s called, is created in just six government-owned nuclear research reactors — none in North America — raising concerns about the reliability of the supply and even prompting federal scientists to warn of the possibility of severe shortages.

Some 50,000 Americans each day depend on a strange and precarious supply chain easily disrupted by a variety of menaces: shipments grounded by fog in Dubai, skittish commercial airline pilots who refuse to carry radioactive material and unplanned nuclear reactor shutdowns, including one in South Africa when a mischievous baboon sneaked into a reactor hall.

Delays that pose an inconvenience for other commercial goods are existential threats in the daily global relay race of medical isotopes that disappear hour by hour. “It’s like running through the desert with an ice cream cone,” said Ira Goldman, senior director of global strategic supply at Lantheus Medical Imaging in North Billerica, Mass.

But that race may soon be shortened. Propelled by persistent supply problems and fears that terrorists could seize American uranium en route to foreign facilities, President Barack Obama signed legislation in 2013 prodding American companies into the medical-isotope business.

The $100 million Janesville plant, in the hometown of Rep. Paul Ryan, speaker of the House, is the first construction project to pass through the labyrinthine nuclear regulatory approval process since 1985 and is being built by SHINE Medical Technologies with $25 million in federal funds.

Greg Piefer, the company’s founder and a nuclear engineer (he drives a Tesla with the license plate “NEUTRON”), has big plans for the cornfield: a plant that could manufacture up to 50,000 doses of imaging agent a week. “Ryan called me out of the blue and he said, ‘We really want you here,’” Piefer said.

Still, it could be years before moly-99 is manufactured in the United States. SHINE still needs more money to complete its manufacturing plant, and investors are wary of the many problems that can arise during construction. Already, construction deadlines promised by SHINE have come and gone. Other competitors, meanwhile, that received tens of millions of dollars in federal grants to build their own moly-99 manufacturing plants have been thwarted by protracted drug approvals and nuclear regulatory hurdles, and some have given up.

European rivals have also cautioned the American upstarts. At industry presentations, Goldman said, the producers have warned, “This is more difficult than it looks. You can’t come up with a fancy slide that says, ‘I’m going to be producing moly-99 in a couple of years.’”

Birth Of An Isotope

The radioactive isotope injected into the veins of potential heart attack victims or bone cancer patients begins its journey in the heavily guarded American nuclear stockpile.

The Department of Energy’s National Nuclear Security Administration ships Cold War-era uranium overseas, where the containers — sought by terrorists for dirty bombs — are secretively trucked to government-owned nuclear research reactors in the Netherlands, Belgium, Czech Republic and Poland. (South Africa and Australia also use American uranium to produce moly-99 in research reactors.)

Private companies rent time in the reactors to irradiate enriched uranium targets, producing an atomic alphabet soup. Nearby processing facilities fish out the moly-99, and the radioactive material is loaded onto commercial airline flights bound for the United States in protective containers.

Three companies dominate the American market for moly-99 — Lantheus, Curium and GE Healthcare. They distribute the material to specialized pharmacies around the country, where technicians process it into a diagnostic imaging agent called technetium-99. The companies work against a ticking clock: Because of its short half-life, just 66 hours for moly-99 and six hours for the imaging agent, the material must be quickly delivered to hospitals and administered to patients.

“The whole industry is like a duck going on a fast-flowing river,” said Kevin Charlton, an analyst at the Organization for Economic Cooperation and Development’s Nuclear Energy Agency in Paris. “On the surface, it looks like things are going very smoothly, but under the water, their legs are going really fast.”

Countless things can go wrong, starting with the first step.

The worldwide supply of moly-99 relies on a fleet of government-subsidized nuclear research reactors built mostly during the Khrushchev-Eisenhower era.

Regular maintenance and major repairs can shutter the reactors, sometimes for months, and so-called scrams — caused by anything from a hiccup in a reactor’s cooling system to an errant lightning strike — frequently halt production. “It’s a nuclear reactor,” Charlton said. “The only thing you can do is shut it off.”

Even the Mayo Clinic in Rochester, Minn., a prestigious cancer treatment center, can be left waiting for shipments of the generators that contain the imaging agent. “We’ve had days when no generator comes in at all, or it’s been cut in half,” said Andrew Paulsen, supervisor of the clinic’s radiopharmaceutical laboratory.

And the ephemeral nature of moly-99 always looms. On a recent afternoon, inside a locked laboratory at Stanford Hospital’s nuclear medicine department in Palo Alto, Calif., a technician held a lead-lined, plastic cylinder containing a syringe of fragile atoms that had traveled around the globe.

Once the imaging agent is injected into a patient’s body, it emits gamma rays that can be detected by gamma cameras that look like X-ray machines. The radioactive tracer lights up on a computer monitor wherever the heart’s blood vessels are blocked or bones are riddled with potentially cancerous tumors. The imaging agent was first used in medical applications in the 1960s because its short half-life meant that patients were getting less exposure to radioactivity than from other diagnostic tracers.

But at Stanford’s nuclear medicine department that day, a patient had missed his appointment. This meant the dose — which cost the hospital an irretrievable $500 — had decayed and was now useless. The technician threw the syringe in the trash.

The supply chain’s vulnerability, acutely felt during a severe worldwide shortage in 2009 and 2010 when two reactors shut down unexpectedly, has led some doctors to shift to more dependable, but more toxic, imaging agents. “For cardiac imaging, we had to shift to a more expensive agent and expose patients to more radiation,” said Dr. Andrei Iagaru, chief of the division of nuclear medicine at Stanford Health Care.

After the worldwide shortage, the volume of nuclear medicine tests went down, and stayed down. “It definitely had an impact on the way many practices run their cardiac stress tests,” Iagaru said.

Depending On Other Countries

American patients consume nearly half of the world’s supply of moly-99. And despite plans to ramp up production in Australia, reactor construction is notoriously tricky. In addition, reactors that are converting for security reasons to low-enriched uranium have lower yields and more waste, according to nuclear scientists.

Concerns about moly-99 shortages heightened in October 2016, when the Canadian government mothballed a reactor in Chalk River, Ontario, that supplied about 40 percent of the American market. The government’s decision to shutter the plant was, in part, due to frustration that Canada had had to spend $70 million in 2009 to repair the facility — in effect, subsidizing the American health care industry. That is a complaint of European governments as well.

William Magwood, director of the Nuclear Energy Agency in Paris, said that moly-99 production at Chalk River “went from being incidental to being the only reason to operate the reactor.”

“Canadians didn’t want to continue to operate a high-cost reactor to sell isotopes to the U.S.,” he said.

Some European governments have begun charging moly-99 producers higher rates to rent reactor time, and prices are expected to rise sharply when governments strip for-profit companies of subsidies originally meant to support academic research.

“How much will get passed on to the health care providers?” said Leah Gannon, senior portfolio executive of radiopharmaceutical distribution sourcing for Vizient, a company that negotiates contracts for hospitals. “Probably almost all of it.”

With no source of moly-99 anywhere in North America, American nuclear medicine specialists appointed by the National Academies of Sciences, Engineering and Medicine warned in a 2016 report commissioned by Congress of a more than 50 percent likelihood of another severe shortage in the coming years.

Moly-99 suppliers refute the report’s findings, a position echoed by the Nuclear Energy Agency, which has fostered closer ties among producing nations. Reactor operators, the suppliers say, work closely to stagger maintenance shutdowns to minimize shortages and respond to disruptions in production, and producers have increased the number of uranium targets.

“We’re describing a glass that is half-full,” Charlton said, “whereas the National Academy of Sciences sees the glass looking half empty.”

Still, nuclear medicine physicians and nuclear pharmacists charged with filling patient orders each day say the supply remains fragile, especially for smaller pharmacies where the moly-99 imaging agent can account for 95 percent of their business. “It is inconceivable to believe that an outage will never occur on any of these old reactors in the future,” said Dr. Joseph Hung, director of radiopharmaceutical operations at the Mayo Clinic and a member of the government committee.

Wendy Galbraith, a clinical associate professor at the University of Oklahoma College of Pharmacy in Oklahoma City who runs the university’s pharmacy, said she frequently doesn’t know if moly-99 is going to be available until the wee hours of the morning. Even when there are no major outages, she said, “it’s a scramble.”

That uncertainty means delays and on-the-fly triage for patients. “If we have a patient who can wait two days for their cardiac stress test, we’ll put them off,” Galbraith said.

Suppliers want to tamp down fears about reliability, physicians and pharmacists say, to dissuade them from seeking alternative imaging methods when possible, like positron emission tomography, a costly and complex type of medical scan.

“It’s hard to stay relevant in an environment when things are not available every now and then,” said Iagaru at Stanford.

Even more troubling, critics say, is the lack of redundancy in the supply chain. Of the four global suppliers, two rely on a single reactor. “If anything goes wrong with the reactors in South Africa and Australia,” Dr. Hung said, “it will be déjà vu again like in 2009.”

The Wisconsin Project

If the United States is to grow a domestic moly-99 supply, it will probably rise from the corn and soybean fields in America’s Dairyland.

Rock County, Wis., has become the unexpected home to two of the three companies vying for control: NorthStar Medical Radioisotopes in Beloit, which has been awarded $50 million in federal grants, and SHINE, or Subcritical Hybrid Intense Neutron Emitter, in Janesville.

Backed by $25 million in federal support, Piefer, SHINE’s chief executive, has promised to build a nuclear accelerator and produce moly-99 by 2020. (The previous deadline was 2015.) In early 2017, the company opened its headquarters in Janesville above the Time Out Pub & Eatery and down the street from a fishing tackle shop and Speaker Ryan’s district office.

Nuclear engineers have moved en masse to Janesville in recent months, decorating their cubicles with hand-painted signs with sayings like, “Think like a proton, stay positive.”

Piefer zips along Highway 90 in his Model S Tesla between Janesville and Monona, a Madison suburb where his research lab, Phoenix Nuclear Labs is located. There, engineers have built a ghostly particle beam that looks like a giant, purple lightsaber.

Eight particle accelerators have been designed for the Janesville plant, which the Nuclear Regulatory Agency approved for construction in 2016. Piefer still needs to raise considerable private capital, a challenge with eager entrants like NorthStar and Nordion, an Ottawa-based company also with aggressive plans to enter the Moly-99 market.

“If we don’t have significant production soon, we will continue to export highly enriched uranium,” Piefer said. “And the National Nuclear Security Administration will have failed their mission.”

The city of Janesville is banking on Piefer. Its economy reeling from the closing of the General Motors plant in 2008, the City Council aggressively pursued SHINE with a generous economic development package, besting two other Wisconsin cities.

In 2011, over the objections of some residents opposed to a nuclear facility in the town, the council authorized $1.53 million to buy 84 acres of farmland, which it has agreed to turn over to SHINE for $1. The city has also agreed to pay $345,000 to extend utilities to the site, provide $2 million in forgivable loans and co-sign a bank loan with SHINE for up to $4 million that it would have to pay should the company fail, a first for the city.

Gale Price, economic development director for the city of Janesville, said that although it was unusual to put public money into a startup, the city expected to recoup its investment within 10 years. “That’s how we measure whether we’re giving away the farm,” he said.

Ryan has championed the project and spoke at a celebration marking nuclear regulatory approval. But Piefer said, except for the initial phone call urging him to come to Janesville, Ryan has played no part in the federal grant and construction approvals.

SHINE jumped at the chance at federal money for the private plant. But Piefer isn’t solely focused on the need in American hospitals. The company has already announced lucrative deals to ship moly-99 to Chinese hospitals.

But first, it needs to start producing.

“You cannot just open a shop down the street and start nuclear medicine,” said Iaragu, of Stanford. “The public comes with an expectation that if my oncologist wants me to get a bone scan, it’s not big deal. But the truth is, it’s a big deal.”

Kentucky Is First State Granted Approval For Medicaid Work Requirements

KFF Health News, January 15, 2018

The approval comes one day after the Trump administration released guidance to states on how to design and test programs that require work as a condition of receiving Medicaid.

This article first appeared January 12, 2018 on Kaiser Health News.

By Phil Galewitz

Thousands of poor adults in Kentucky will have to find jobs and pay monthly premiums to retain their Medicaid coverage as a result of drastic changes to the state’s health insurance program approved Friday by the Trump administration.

With the long-expected decision, Kentucky becomes the first state to win federal approval to test a new work requirement in Medicaid, a controversial policy shift likely to result in a court battle over whether the administration overstepped its legal authority.

“I was raised by a father who said, ‘Don’t take something that is not earned,’” said Republican Gov. Matt Bevin in announcing the approval of Kentucky’s Medicaid waiver. “The vast majority of able-bodied men and women, able-bodied Kentuckians, they want the dignity associated with being able to earn and have engagement in the very things they are receiving, and an opportunity not to be put in a dead-end entitlement trap but given a path forward and upward.”

Radio story by Jake Harper, Side Effects Public Media, a news collaborative covering public health.

Conservatives say the work requirement can help lead people to employment and off the state-federal health program. Democrats, health providers and patient groups say the measure adds another stumbling block for people to keep their coverage.

“By lessening dependence on government assistance and promoting individual self-sufficiency, Kentucky’s efforts should also help to promote the fiscal sustainability of the program to better protect services for the Commonwealth’s most vulnerable,” Demetrios Kouzoukas, principal deputy administrator of the Centers for Medicare & Medicaid Services, wrote in his Kentucky approval letter. “Overall, CMS believes that Kentucky HEALTH [Helping to Engage and Achieve Long Term Health] has been designed to empower individuals to improve their health and well-being.”

The approval comes one day after the Trump administration released guidance to states on how to design and test programs that require work as a condition of receiving Medicaid.

A study by the Kaiser Family Foundation found that 6 in 10 non-disabled adults on Medicaid already work at least part time, although they often aren’t offered health benefits through those jobs or can’t afford them. (Kaiser Health News is an editorially independent program of the foundation.)

Surveys show that many Medicaid enrollees who don’t work are in job training, go to school or are taking care of a child or an elderly relative, conditions that would make them exempt from the new mandate, according to the CMS guidelines.

Kentucky’s program would require non-disabled adults each month to participate in 80 hours of work, job training, education or other qualified “community engagement.”

Those who are exempted include children and former foster care kids, pregnant women, senior citizens, people who are the primary caretakers for a child or a disabled adult, those who are deemed medically frail or diagnosed with an acute medical condition that would prevent them from working, and full-time students.

Officials acknowledge that the work requirement — coupled with other changes in its waiver request — would lead to about 95,000 fewer people enrolled after five years. But many of those would drop out not because of finding work but because they can’t overcome the new bureaucratic hurdles, say advocates for the poor.

“We expect that fewer people will be able to stay enrolled in coverage due to all of the red tape and penalties they’ll encounter,” said Emily Beauregard, executive director for Kentucky Voices for Health, an advocacy group. “Keeping up with the reporting requirements alone will be enough of a burden on people who have two or three part-time jobs that they’ll either lose coverage at some point or may decide it’s not worth enrolling to begin with.”

The Kentucky approval brings other major changes to the state’s Medicaid program, which has doubled in enrollment to 1.2 million people since the state expanded eligibility in 2014 under the federal Affordable Care Act.

The revisions would cut dental and vision coverage for many adults, although they can regain it by completing health-related activities, such as taking a disease management class or volunteering.

Individuals with income above the poverty level ($12,060) who do not pay their premiums in 60 days will be kicked out of coverage for six months. Enrollees can return to the program earlier if they pay two months of missed premiums and make one new premium payment. They also must complete a financial or health literacy course.

The state also eliminates its non-emergency transportation benefit for some adults in the program.

Under Kentucky HEALTH, enrollees will make a monthly payment ranging from $1 to $15 depending on income. Pregnant women and children will be exempt from that cost sharing.

The Kentucky Medicaid changes generally mimic those of neighboring Indiana, which altered its program in 2015 under then-Gov. Mike Pence.

CMS Administrator Seema Verma recused herself from the Kentucky decision because she had worked with state officials on the waiver request when she was a consultant before joining the Trump administration.

Kentucky is one of 10 states that have applied to CMS to enact a work requirement.

The work requirement is one of the biggest changes in the history of Medicaid, which covers more than 74 million people, or about 1 in 5 Americans. It is the nation’s largest health insurance program.

The majority of enrollees in Medicaid are children, pregnant women and elderly nursing home residents. But the expansion under President Barack Obama led to millions of non-disabled low income adults added to the program.

Update: This story was updated on Jan. 12 to add information from the governor and more details on the Kentucky waiver once they were released.

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