Clinicians Who Learn Of A Patient's Opioid Death Modestly Cut Back On Prescriptions

KFF Health News, August 9, 2018

The ones who knew about the overdose death cut the overall volume of opioids they prescribed by almost 10% over three months, while those who didn’t know prescribed roughly the same amount as before.

This article first appeared August 10, 2018 on Kaiser Health News.

By Anna Gorman

Physicians and other medical providers modestly reduced the volume of opioids they prescribed after being told one of their patients had died of an overdose, according to research published Thursday.

"You can hear a lot of statistics about the crisis," said Jason Doctor, lead author of the study, published Thursday in the journal Science. "But it always feels like it is happening elsewhere if you are not aware of any deaths in your own practice."

The research included more than 800 clinicians — doctors, nurse practitioners, physician assistants and dentists — comparing those who received a letter from the medical examiner about a patient's death and those who didn't. The ones who knew about the overdose death cut the overall volume of opioids they prescribed by almost 10 percent over three months, while those who didn't know prescribed roughly the same amount as before.

The study shows that awareness and education can change prescribing behavior, said Doctor, lead author and associate professor at University of Southern California's Price School of Public Policy. The modest size of the reduction among those who were notified of a death suggests "that clinicians exercised greater caution with opioids rather than abandoning use," according to the study.

The providers in the study who were informed about patients' deaths were also 7 percent less likely to start new patients on opioids.

The letter did not blame providers for the deaths but showed that authorities were paying attention, according to the study.

"We were providing them with important information and also giving them a way to make things better by changing prescribing," Doctor said. "Anyone who got the letter could continue to prescribe as much as they wanted, but we found that they didn't. They became more judicious prescribers."

Over 19,000 people died from prescription opioids in 2016, roughly double the number 14 years earlier, according to the National Institute on Drug Abuse. Most of that increase occurred from 2002 to 2011, and the numbers have been relatively stable since then, according to the NIDA.

Meanwhile, prescriptions of opioids are declining, and health officials are seeking ways to accelerate the trend.

The study did not measure whether the letters from the medical examiner or the changes in prescribing patterns had any effect on patient deaths.

Across the country, physicians have been accused of overprescribing opioids and have even faced charges related to patient overdose deaths. In an effort to better track prescribing patterns, states have started prescription drug monitoring databases.

The CDC recommends that providers avoid opioids if possible, but if they are necessary, they should start with the lowest effective dose.

Pharmacy-Made Pain Creams Flagged On Fears Of Medicare Fraud And Risk

KFF Health News, August 9, 2018

Most of the prescriptions were for pain treatment, made from ingredients such as lidocaine, an anesthetic, or diclofenac sodium, an anti-inflammatory drug.

This article first appeared August 09, 2018 on Kaiser Health News.

By Julie Appleby

Medicare pays hundreds of millions of dollars each year for prescription creams, gels and lotions made-to-order by pharmacies — mainly as pain treatments. But a new report finds that officials are concerned about possible fraud and patient safety risks from products made at nearly a quarter of the pharmacies that fill the bulk of those prescriptions.

"Although some of this billing may be legitimate, all of these pharmacies warrant further scrutiny," concludes the report from the Office of the Inspector General for the Department of Health and Human Services.

In total, 547 pharmacies — nearly 23 percent of those that submit most of the bills to Medicare for making these creams — hit one or more of five red-flag markers set by investigators. Those included what the researchers called "extremely high" prices; large percentages of Medicare members getting identical drugs — 16 of the pharmacies billed for identical drugs for 200 or more customers; "greatly increased" year-over-year billing — 20 pharmacies increased their billing by more than 10,000 percent; or having a single medical provider writing more than 131 prescriptions. More than half of those pharmacies hit two or more measures — and 10 hit all five.

One Oregon pharmacy, for example, submitted claims for 91 percent of its customers. A pharmacy in New York submitted 5,342 prescriptions ordered by one podiatrist, while a Florida pharmacy saw its Medicare billing for such treatments go from $7,468 in 2015 to $1.8 million the following year.

Many of the pharmacies are clustered in four cities: Detroit, Houston, Los Angeles and New York.

The report comes amid ongoing concern by Medicare officials about these custom-made — or compounded — drugs. In addition to questions like those raised in the report about overuse and pricing, safety has been a key issue in recent years. A meningitis outbreak in 2012 was linked to a Massachusetts pharmacy that did not maintain sterile conditions and sold tainted made-to-order injections that killed 64 Americans.

When done safely, pharmacy-made compounded drugs provide a legitimate option for patients whose medical needs can't be met by commercially available products mass-produced by pharmaceutical companies. For example, a patient who can't swallow a commercially available prescription pill might get a liquid version of a drug.

State boards of pharmacy generally oversee compounding pharmacies, and the drugs they produce are not considered approved by the Food and Drug Administration.

The new report focuses on concerns with compounded topical medications.

Medicare spending for such treatments has skyrocketed, rising more than 2,350 percent, from $13.2 million in 2010 to $323.5 million in 2016. Price hikes and an increase in the number of prescriptions written drove the increase, the report said.

It is not the first time the inspector general has looked at compounded drugs. A 2016 report found that overall spending on all types of compounded drugs — not just topical medications — rose sharply. The U.S. Postal Service inspector general and the Department of Defense also have raised concerns about rising spending and possible fraud for compounded drugs.

In response to those previous reports, the International Academy of Compounding Pharmacists, the industry's trade group, has said that legitimately compounded drugs "can dramatically improve a patient's quality of life," noting that proper billing controls need to be in place. The inspector general's report in 2016, it added, found that "such controls are not in place."

This report, which the compounding trade group has not yet reviewed, focuses on topical drugs and a subset of the 15,290 pharmacies that provide at least one such prescription each year. It looked at billing records from the 2,388 pharmacies that do at least 10 such prescriptions a year — providing 93 percent of all compounded topical drugs paid for by Medicare.

Most of the prescriptions were for pain treatment, made from ingredients such as lidocaine, an anesthetic, or diclofenac sodium, an anti-inflammatory drug.

On average, those compounds were more expensive than non-compounded drugs with the same ingredients.

For example, Medicare paid an average of $751 per tube of compounded lidocaine, and $1,506 for the diclofenac, according to the inspector general's report. Non-compounded tubes of those drugs averaged $445 and $128, respectively.

FDA Commissioner Scott Gottlieb recently outlined new efforts his agency is taking to oversee compounded drugs in the wake of legislation passed by Congress following the meningitis outbreak.

"The FDA is inspecting compounding facilities to assess whether drugs that are essentially copies of FDA-approved drugs are being compounded for patients" who could otherwise take a product sold commercially, he said in a statement issued on June 28.

Gottlieb also said the FDA plans to make more information available to patients and their doctors about compounded topical pain creams, including information about their effectiveness and any potential safety risks.

Not being effective is a safety risk, noted Miriam Anderson, a researcher with the inspector general's office who helped write the report.

The report urged the Centers for Medicare & Medicaid Services to clarify some of its policies to emphasize that insurers can limit the use of compounded drugs by requiring prior authorization or other steps. The agency concurred with the recommendations, according to the report, including the need to "follow up on pharmacies with questionable Part D billing and the prescribers associated with these pharmacies."

Anderson said the inspector general's office is continuing to probe the issue.

"We will investigate a number of leads on specific pharmacies and prescribers who were identified as having these questionable patterns," she said. "Whenever we see that kind of increase in spending, it raises concern about fraud, waste and abuse."

Once Its Greatest Foes, Doctors Are Embracing Single-Payer

KFF Health News, August 7, 2018

The battle lines are shifting as younger doctors flip their views, a change that will likely assume greater significance as the next generation of physicians takes on leadership roles.

This article first appeared August 07, 2018 on Kaiser Health News.

By Shefali Luthra

When the American Medical Association — one of the nation's most powerful health care groups — met in Chicago this June, its medical student caucus seized an opportunity for change.

Though they had tried for years to advance a resolution calling on the organization to drop its decades-long opposition to single-payer health care, this was the first time it got a full hearing. The debate grew heated — older physicians warned their pay would decrease, calling younger advocates naïve to single-payer's consequences. But this time, by the meeting's end, the AMA's older members had agreed to at least study the possibility of changing its stance.

"We believe health care is a human right, maybe more so than past generations," said Dr. Brad Zehr, a 29-year-old pathology resident at Ohio State University, who was part of the debate. "There's a generational shift happening, where we see universal health care as a requirement."

The ins and outs of the AMA's policymaking may sound like inside baseball. But this year's youth uprising at the nexus of the medical establishment speaks to a cultural shift in the medical profession, and one with big political implications.

Amid Republican attacks on the Affordable Care Act, an increasing number of Democrats — ranging from candidates to established Congress members — are putting forth proposals that would vastly increase the government's role in running the health system. These include single-payer, Medicare-for-all or an option for anyone to buy in to the Medicare program. At least 70 House Democrats have signed on to the new "Medicare-for-all" caucus.

Organized medicine, and previous generations of doctors, had for the most part staunchly opposed to any such plan. The AMA has thwarted public health insurance proposals since the 1930s and long been considered one of the policy's most powerful opponents.

But the battle lines are shifting as younger doctors flip their views, a change that will likely assume greater significance as the next generation of physicians takes on leadership roles. The AMA did not make anyone available for comment.

Many younger physicians are "accepting of single-payer," said Dr. Christian Pean, 30, a third-year orthopedic surgery resident at New York University.

In prior generations, "intelligent, motivated, quantitative" students pursued medicine, both for the income and because of the workplace independence — running practices with minimal government interference, said Dr. Steven Schroeder, 79, a longtime medical professor at the University of California-San Francisco.

In his 50 years of teaching, students' attitudes have changed: "The 'Oh, keep government out of my work' feeling is not as strong as it was with maybe older cohorts," said Schroeder. "Students come in saying, 'We want to make a difference through social justice. That's why we're here.'"

Though "single-payer" health care was long dismissed as a left-wing pipe dream, polling suggests a slim majority of Americans now support the idea — though it is not clear people know what the term means.

A full single-payer system means everyone gets coverage from the same insurance plan, usually sponsored by the government. Medicare-for-all, a phrase that gained currency with the presidential campaign of Sen. Bernie Sanders (I-Vt.), means everyone gets Medicare, but, depending on the proposal, it may or may not allow private insurers to offer Medicare as well. (Sanders' plan, which eliminates deductibles and expands benefits, would get rid of private insurers.)

Meanwhile, lots of countries achieve universal health care — everyone is covered somehow — but the method can vary. For example, France requires all citizens purchase coverage, which is sold through nonprofits. In Germany, most people get insurance from a government-run "public option," while others purchase private plans. In England, health care is provided through the tax-funded National Health System.

American skeptics often use the phrase "socialized medicine" pejoratively to describe all of these models.

"Few really understand what you mean when you say single-payer," said Dr. Frank Opelka, the medical director of quality and health policy for the American College of Surgeons, which opposes such a policy. "What they mean is, 'I don't think the current system is working.'"

But the willingness to explore previously unthinkable ideas is evident in young doctors' ranks.

Recent surveys through LinkedIn, recruiting firm Merritt Hawkins and trade publication NEJM Catalyst indicate growing support. In the March NEJM survey, 61 percent of 607 respondents said single-payer would make it easier to deliver cost-effective, quality health care.

Delving further, that survey data shows support is stronger among younger physicians, said Dr. Namita Mohta, a hospitalist at Brigham and Women's Hospital and clinical editor at NEJM Catalyst.

But it's unclear whether these findings reflect young doctors' feelings about the policy or whether they are tapping in to broader frustrations with the American health system.

Much like the general public, doctors often use terms like single-payer, Medicare-for-all and universal health care interchangeably.

"Our younger generation is less afraid to come out and say we want universal health care," said Dr. Anna Yap, 26, an emergency medicine resident at UCLA, who served as a medical student delegate to the AMA until this past June. "But how? It's different in what forms we see."

Younger doctors also pointed to growing concern about how best to keep patients healthy. They cited research that broadly suggests having health insurance tracks with better health outcomes.

"Medical students, I would say, are very interested in public health and improving social determinants of health — one of them being access to health insurance," said Dr. Jerome Jeevarajan, 26, a neurology resident at the University of Texas-Houston, referring to non-medical factors that improve health, such as food or housing.

Some of the shift in opinion has to do with the changing realities of medical practice. Doctors now are more likely to end up working for large health systems or hospitals, rather than starting individual practices. Combined with the increasing complexity of billing private insurance, many said, that means contracting with the government may feel like less of an intrusion.

The debate is, at this point, still theoretical. Republicans — who control all branches of the federal government — sharply oppose single-payer. Meanwhile, single-state efforts in California, Colorado and New York have fallen flat.

Also, doctors represent only one part of the sprawling health care industrial complex. Other health care interests — including private insurance, the drug industry and hospital trade groups — have been slower to warm to catchphrases like single-payer or universal health care, all of which would likely mean a drop in income.

But increasingly physicians seem to be switching sides in the debate, and young physicians want to be part of the discussion.

"There's tremendous potential … to be at the table if single-payer becomes a significant part of the political discourse, and create a system that is more equitable," Pean said.

In Weary Post-Storm Puerto Rico, Medicaid Cutbacks Bode New Ills

KFF Health News, August 6, 2018

Physicians, health insurers, and former government officials say the drastic cuts defy actuarial science and provide too little money.

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

By Sarah Varney and Carmen Heredia Rodriguez

SAN JUAN, Puerto Rico — Blue tarps still dot rooftops, homes lack electricity needed to refrigerate medicines, and clinics chip away at debts incurred from running generators. Yet despite the residual effects from last year's devastating hurricanes, Puerto Rico is moving ahead with major cuts to its health care safety net that will affect more than a million of its poorest residents.

The government here needs to squeeze $840.2 million in annual savings from Medicaid by 2023, a reduction required by the U.S. territory's agreement with the federal government as the island claws its way back from fiscal oblivion.

Overall, Puerto Rico faces a crushing debt of more than $70 billion — much of it due to the territory's historically astronomical Medicaid expenses — on an island where the average household earns $20,000 and diabetes and hypertension are widespread.

But physicians, health insurers and former government officials say the drastic cuts demanded defy actuarial science and provide too little money to care for a population still traumatized by Hurricane Maria.

The cutbacks will give private health insurance companies the incentive to shuttle around patients with costly chronic diseases or mental illness, critics warn. And they do nothing to address the underlying fiscal imbalance at the root of Puerto Rico's health care woes, which stem from the fact that the federal government contributes a tiny fraction of the island's Medicaid budget, compared to what it contributes to the 50 U.S. states.

"We are rearranging the chairs on the Titanic," said Dr. Jaime Torres, whose jurisdiction included Puerto Rico when he served as a regional director of the Department of Health and Human Services.

Already health plans have been forced to lay off social workers and nurses like Eileen Calderón, who once visited dozens of chronically ill Puerto Ricans each month, finding them specialists, supervising medicine compliance and arranging rides to doctor appointments.

"These people who have been under our service for the last four or five years, all of a sudden I have to abandon them," said Dr. José Joaquín Vargas, chief medical adviser for VarMed, the Bayamon-based company that operated the program that employed Calderón.

Health Crippled By Debt

If Puerto Rico were a state, the federal government would pay 83 percent of Medicaid costs. (It pays upward of 70 percent of Medicaid expenses in 10 states, according to a formula that takes a state's economy into account.) But because of a 1968 law capping the amount of Medicaid money Washington sends to U.S. territories, the federal government pays only about 19 percent, as a fixed annual payment — a so-called block grant.

In February, Congress approved $4.8 billion in additional funds to help pay the island's Medicaid bills. But the additional payments are widely viewed as a stopgap measure; health economists say that extra money is likely to run out in September 2019, a grim estimate shared by the territory's fiscal oversight board. That's a federal control board established by Congress in 2016 to oversee Puerto Rico's budget, negotiate with its creditors and help restructure at least some of the island's debt.

Gov. Ricardo Rosselló's administration aims to reduce Medicaid spending and improve access to care by putting an end to years of regional monopolies by private health insurance companies. The insurers have locked patients into narrow networks of health care providers. Later this year, under Rosselló's plan, the companies will be forced to offer island-wide insurance plans and compete for customers.

"We do not have the luxury" of continuing to spend inefficiently, said Ángela Ávila Marrero, executive director of Puerto Rico's Health Insurance Administration.

If Rosselló's overhaul fails to achieve adequate savings — as most observers predict — drastic cuts are in the offing. Some 1.1 million Puerto Rican residents on Medicaid — out of 1.6 million enrollees — are at risk of losing coverage next fall, their health held hostage to the island's need to pay back its crippling debt.

Puerto Rico's government effectively defaulted on more than $70 billion in debt. Economists blame a decades-long recession, a corporate tax break that ended in 2006 and reckless spending by a bloated government.

But also to blame, they say, and largely unnoticed in discussions of the debt, is Puerto Rico's staggering Medicaid burden.

Poverty is so pervasive here that nearly 1 in 2 people qualify for public health insurance; Medicaid expenses in 2016 totaled $2.4 billion. Residents suffer from higher rates of chronic conditions like diabetes and asthma, and the percentage of people who are elderly is quickly rising.

Footing medical bills without the kind of federal assistance dispensed to states has effectively doomed the island's fiscal health, health economists say.

Researchers of health care say that, putting aside interest on Puerto Rico's debt, the territory's primary fiscal deficit would have been erased had Congress paid the same share of Medicaid bills that it pays the 50 states and Washington, D.C.

"The main issue is that we are not yet a state," said Rep. Jenniffer González-Colón, the commonwealth's nonvoting member of Congress. The island must pay for Medicaid, she added, "with local funds that we don't have."

Battered Even Before The Storm

Puerto Rico's health care system was already convulsing in September 2017 when Hurricane Maria struck. The federal government had issued warnings that the island would soon run out of additional Medicaid funds provided by the Affordable Care Act and 900,000 Puerto Rican residents would lose coverage.

Insurance companies, hospitals and physicians complained that the government was chronically late paying its bills. That frustration forced hospitals to defer maintenance and investments in new technology and fueled the exodus of thousands of physicians to the mainland in search of better incomes.

Today, Medicaid patients face long waits to see doctors on the island.

"If your kid needs a neurologist, for example, the waiting period is around six to 12 months," said Dr. Jorge Rosado, a pediatrician in San Juan. "For a genetics specialty, it's two to three years."

The $4.8 billion in relief funding from Congress is propping up Medicaid while the Rosselló administration negotiates new contracts with health insurance companies and enacts other measures mandated by the fiscal oversight board. Those include a new Medicaid fraud detection system and enhanced data collection.

Little Time To Waste

Barring the unlikely passage of bills that would eliminate the cap on federal Medicaid spending in Puerto Rico, the disaster relief fund is projected to run out next fall. González-Colón also authored a bill calling for statehood, which would eliminate the federal government's unequal treatment toward the island's Medicaid program.

The fiscal control board established by Congress openly acknowledges the impending disaster. In an April 19 report, the board projects monthly costs per Medicaid patient will rise nearly 40 percent over the next six years, barring any changes, and that Puerto Rico "will hit a 'Medicaid cliff.'"

Beginning this fall, Medicaid patients will be able to pick from at least four insurers, instead of being assigned to the one that had covered their ZIP code.

Puerto Rico has long capped monthly payments insurers receive for Medicaid patients regardless of how many medical services they use, a form of managed care. But the government here believes that the insurers — without their regional monopolies — will be forced to compete, offering better care and more efficient delivery. They could save money by reducing unnecessary emergency room visits or hospital stays and by negotiating discounted payment rates to providers.

The island's government has vowed to pay private insurers extra money to care for those with expensive or chronic medical conditions. Insurers have cautiously welcomed the changes.

"I support the government on what they're trying to do, but they didn't price it properly," said Dr. Richard Shinto, the president and chief executive of InnovaCare, an insurance company that sells plans in Puerto Rico.

He added, "The oversight board is fixated on cuts, but we're never going to improve health care unless more money is put into the system."

Government health officials argue Medicaid patients, especially those outside the San Juan metropolitan area, will gain access to more specialists, who are concentrated in the capital. But the island's clinics and hospitals fear they will be squeezed by insurers seeking to lower costs, just as they are still reeling from hurricane-related expenses.

Hospital General de Castañer spent $5,000 every five days for gasoline to power the generators at its three sites for seven months; Health Pro Med, a community health center, spent at least $2,000 a day in added expenses, including private flights to ferry doctors to the storm-battered island of Vieques.

Many experts are skeptical that managed-care companies will hire the army of social workers and nurses like Calderón needed to trudge up hillsides, knock on doors and do the tedious work that entails solving the daily problems of poverty. Viewed through a narrow lens, with an eye for cutting expenses, such problems can seem far outside the purview of medicine.

Many people displaced by the storm haven't yet been able to return home, and that, too, can complicate health care delivery. Carmen Ramos, executive director of Redes del Sureste, a conglomerate of 22 medical groups in Puerto Rico, says 60 percent of the letters she recently sent to patients on her mailing list were returned.

"The managed-care companies need to produce revenue," said Victoria Sale, a senior director at Camden Coalition, a pioneer of social and health programs for the chronically ill. "That's a setup for concern."

Bottom line? The economic overhaul doesn't rectify Puerto Rico's fundamental problem — it can't sustain its Medicaid program so long as Congress treats the territory differently than it treats states.

"Next year, we will go back to Congress demanding the funding we deserve as U.S. citizens," said Torres. But, he added, "it's time the local government started thinking about a Plan B."

Doctors Reckon With High Rate Of Suicide In Their Ranks

KFF Health News, August 3, 2018

An estimated 300 to 400 doctors kill themselves each year, and the suicide rate is more than double that of the general population.

This article first appeared August 03, 2018 on Kaiser Health News.

By Blake Farmer, Nashville Public Radio

Alarms go off so frequently in emergency rooms, doctors barely notice. And then a colleague is wheeled in on a gurney, clinging to life, and that alarm becomes a deafening wake-up call.

"It's devastating," said Dr. Kip Wenger, recalling a 33-year-old physician and friend who died by suicide in 2015. "This is a young, healthy person who has everything in the world ahead of them."

The medical profession is built on the myth that its workers are all highly conditioned athletes — clocking long hours while somehow staying immune to fatigue and the emotional toll of their jobs.

But there's a dark side to the profession that has been largely veiled — even from doctors themselves: They are far more likely than the general population to take their own lives.

Wenger said his colleague was a confident doctor who worked with him in emergency rooms all over Knoxville, Tenn., and died in one of those same ERs. Wenger is regional medical director for TeamHealth, one of the country's largest emergency room staffing companies, based in Knoxville.

One of the unavoidable dangers of being a doctor is knowing exactly how to kill yourself and having easy access to the tools to do it. There are stories of anesthesiologists found in a hospital, hooked up to an IV. Wenger said his colleague used numbing agents in order to die more painlessly.

"She wrapped herself in a blanket, and she got a Bible," Wenger said. "She wrote a note on the door to her best friend. ‘If you come here, don't come in the door. Call Kip or call Peter and they'll know what to do.' And that's how she checked out."

This young doctor had confided in a few co-workers about recent relationship struggles, but nothing that affected her work. And then she became part of the grim statistics.

"She was very strong-willed, strong-minded, an independent, young female physician," said emergency doctor Betsy Hull, a close friend. "I don't think any of us had any idea that she was struggling as much personally as she was for those several months."

Addressing An Uncomfortable Reality

An estimated 300 to 400 doctors kill themselves each year, and the suicide rate is more than double that of the general population, according to a review of 10 years of literature on the subject presented at the American Psychiatry Association annual meeting in May.

For TeamHealth, the young woman's death in 2015 sparked some deep soul-searching.

"A few of these things happened that were just so sobering," said TeamHealth co-founder Dr. Lynn Massingale. "People don't stab themselves to death. Young people don't stab themselves to death."

It's been an uncomfortable topic to address. A 2018 study from Mayo Clinic finds disenchanted doctors are more likely to make mistakes.

But TeamHealth held listening sessions and realized that burnout was rampant. To start, they began encouraging doctors to work less. Massingale said the company average is now close to 40 hours a week — though there's no avoiding nights and weekends in the ER.

The company also started a new protocol for one of the most stressful times in a physician's career: when doctors are sued. The company then pairs them with someone who has been there.

"We can't change the facts. We're not coaching you to change your memory," Massingale said. "But we can help you deal with the stress of that."

And TeamHealth is trying to reduce some bureaucratic headaches. A significant portion of the required corporate training has been deemed optional. And the company began spending millions of dollars a year to hire scribes — staff members who follow around ER physicians and enter information into sometimes finicky electronic health records.

Technology has become a real source of stress in a career that comes with lots to worry about, even beyond dealing with patients.

Dr. Jeffrey Zurosky, who is an ER director at Parkwest Medical Center in Knoxville, said he's concerned for his youngest doctors who start out with a mountain of med school debt, eager to pick up as many shifts as possible.

"I tell them: Be balanced. Don't overwork yourself. Spend time with your family. Stay married, if you can," Zurosky said.

Yet to some in the medical community, the problem is far more fundamental than "burnout." Pam Wible doesn't even like the term, since it puts the burden on physicians, as if they just have to find a way to cope. The family practitioner from Eugene, Ore., sees it all starting in medical schools. Entrenched ideals, like muscling through long hours on little sleep, are hard to break. Wible calls it abuse.

"These people who have been previously abused are now the teachers," she said. "They're teaching the next generation of doctors."

Too Close To Call For Help

And when physicians do want help, the industry makes it especially difficult. Wible said they can't go see a psychiatrist without jeopardizing their medical license.

"I know a lot of them," Wible said. "They're having to sneak out of town, pay cash and use a fake name to do it. Why are we putting these people in such a situation?"

Wible has collected more than 900 stories of doctor suicides and set up an anonymous help line. She has inspired more physicians to share their experiences, such as an emergency doctor licensed in Ohio.

"You don't focus on the 99 you save," that ER doctor said. "You end up focusing on the one that you lose."

The one he lost was 19 years old and came in with the flu, but tests didn't show anything unusual. He sent her home. She returned in cardiac arrest. When he found out she died, he went to a dark place — despite no history of depression.

"Like all doctors, you put that Superman cape on and you think you can get through it," he said.

The family filed a complaint. And being told he might lose his job pushed him over the edge. He swallowed a lethal overdose. But the police found him, and got him to a hospital where he had to be revived.

This ER doc had treated untold numbers of suicidal patients but never saw himself in their place.

"I didn't know I was at higher risk of suicide than the average person," he said.

Kaiser Health News and NPR are not naming this doctor because his story could affect his future career. But he said he wishes he could speak more freely, thinking it might encourage physicians to seek help sooner than he did.

How Rival Opioid Makers Sought To Cash In On Alarm Over OxyContin's Dangers

KFF Health News, August 2, 2018

The growing cluster of lawsuits argue that drugmakers set out to deceive doctors and the public by claiming their products presented little risk.

This article first appeared August 02, 2018 on Kaiser Health News.

By Fred Schulte

As Purdue Pharma faced mounting criticism over deaths linked to OxyContin, rival drugmakers saw a chance to boost sales by stepping up marketing of similarly dangerous painkillers, such as fentanyl, morphine and methadone, Purdue internal documents reveal.

Purdue’s 1996-2002 marketing plans for OxyContin, which Kaiser Health News made public this year for the first time, offer an unprecedented look at how that company spent millions of dollars to push opioids for growing legions of pain sufferers. A wave of lawsuits demanding reimbursement and accountability for the opioid crisis now ravaging communities has heightened awareness about how and when drug makers realized the potential dangers of their products.

The Purdue documents lay out how the company and its biggest competitors were jockeying for market share. Some of those drugmakers’ sales promotions downplayed or ignored the risks of taking opioids, or made false claims about their safety, federal regulators have asserted in warning letters to the companies.

Purdue first offered OxyContin as a remedy for moderate to severe cancer pain in 1996. Within three years, the company viewed the cancer market as too limited, with $261 million in potential annual sales versus $1.3 billion for a broader range of chronic pain care, the company’s marketing reports said.

“That was a pretty good recipe for a blockbuster,” said Andrew Kolodny, who directs Physicians for Responsible Opioid Prescribing, an advocacy group critical of drug industry marketing.

Purdue has become the most high-profile drugmaker linked to the surging opioid crisis. But other opioid manufacturers didn’t sit by idly as sales of OxyContin skyrocketed, topping $1 billion in 2000, despite reports of overdose deaths and addiction.

Purdue’s marketing reports indicate the company was worried about losing business to fentanyl-laced patches called Duragesic, as well as morphine pills and, to a lesser degree, methadone — which some managed-care groups and Medicaid health plans preferred because it cost much less than OxyContin. Methadone and morphine are made by a variety of drug companies.

In its 1999 marketing report, Purdue noted that Janssen Pharmaceuticals, an arm of drug giant Johnson & Johnson, was making “slow but steady” progress in promoting its Duragesic patches. The patches, which users attach to their skin, deliver a dose of fentanyl, an opioid drug about 50 to 100 times more powerful than morphine, according to the Drug Enforcement Administration.

Purdue estimated that Janssen would spend about $4 million in 1999 on medical journal advertising to persuade doctors to prescribe the patches for “early treatment of non-cancer pain and pain in the more frail elderly.” That is more than triple what Janssen spent the year before, according to the 2000 Purdue marketing report. In a statement to KHN, a Janssen spokesman said the company quit “actively marketing” Duragesic in 2008.

Purdue also spent millions on medical journal ads — and like Janssen, it drew criticism from the Food and Drug Administration for minimizing the dangers of opioids, government records show.

In 2000, the Food and Drug Administration criticized Purdue for exaggerating the benefits of using OxyContin to treat arthritis, while in 2003 the agency found that some other ads had “grossly overstated” OxyContin’s safety.

Janssen also drew the ire of the FDA. In March 2000, the agency called some claims made for Duragesic “false or misleading,” including the suggestion that the drug “has less potential for abuse than other currently available opioids.”

In September 2004, the FDA told Janssen to “immediately cease” making “false or misleading” claims, including saying that Duragesic was “less abused than other opioid drugs.” In its statement to KHN, Janssen said its marketing actions were “appropriate and responsible,” adding that it “acted quickly to investigate and successfully resolve FDA’s inquiries.”

The Purdue marketing reports are part of a cache of documents the company provided to the Florida attorney general’s office in 2002. The Florida attorney general released them to two Florida newspapers in 2003 after Purdue lost a court battle to keep them under wraps.

More than 1,500 groups, mostly cities, counties and states, are suing Purdue Pharma, Janssen and several competitors and drug distributers in federal court in Cleveland demanding reimbursement for treatment costs and other compensation. In a statement to KHN, Purdue said: “We vigorously deny these allegations and look forward to the opportunity to present our defense.”

The growing cluster of lawsuits argue that drugmakers set out to deceive doctors and the public by claiming their products presented little risk.

For its part, Purdue accused Janssen of trying to exploit public alarm over OxyContin-linked deaths to spark new sales of Duragesic.

“It has been reported that Janssen sales representatives are using improper techniques to capitalize on the negative press surrounding OxyContin Tablets and the issue of abuse and diversion,” reads the 2002 Purdue marketing plan.

In fact, opioids made by Purdue’s rivals also contributed to overdose deaths in those years and have continued to do so. In 2016, more than 42,000 people died nationwide from opioid-related causes, according to the Department of Health and Human Services.

Florida was one of the early states to see a rise in overdose deaths tied to prescription drugs. Florida medical examiner’s toxicology reports in 2002 detected oxycodone, the active ingredient in OxyContin, in hundreds of overdose fatalities. Abusers realized they could crush the pills and inject or snort the powder to get high. Many others died after mixing the pills with sedatives also prescribed by their doctors.

Florida medical examiner files also showed that abuse of fentanyl pain patches, methadone and morphine took many lives. Some abusers had figured out how to drain the Duragesic patch of its liquid fentanyl and inject it like heroin, or otherwise ingest it.

In July 2005, the FDA warned health care professionals about abuse of fentanyl patches. In December 2007, FDA cited reports of deaths and “life-threatening adverse events” when the fentanyl patch “was used to treat pain in opioid-naïve patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently and exposed the patch to a heat source.”

Purdue also kept an eye on methadone, noting in a 1999 marketing plan that “market research as well as reports from the sales force indicates that methadone use is increasing in both the management of cancer pain and non-malignant pain due to its low cost.” But as methadone won acceptance for treating pain, it also began to kill with alarming frequency.

The FDA in November 2006 warned of deaths and dangerous side effects among patients “newly starting methadone for pain control and in patients who have switched to methadone after being treated for pain with other strong narcotic pain relievers.”

Patients With Chronic Pain Feel Caught In An Opioid-Prescribing Debate

KFF Health News, August 1, 2018

Faced with skyrocketing drug overdoses, states are cracking down on opioid prescribing. Some patients with chronic pain say they are becoming collateral damage.

This article first appeared August 01, 2018 on Kaiser Health News.

By Will Stone, KJZZ

It started with a rolled ankle during a routine Army training exercise. Shannon Hubbard never imagined it was the prologue to one of the most debilitating pain conditions known to exist, called ­­­­­­­complex regional pain syndrome.

The condition causes the nervous system to go haywire, creating pain disproportionate to the actual injury. It can also affect how the body regulates temperature and blood flow.

For Hubbard, it manifested years ago following surgery on her foot — a common way for it to take hold.

"My leg feels like it's on fire pretty much all the time. It spreads to different parts of your body," the 47-year-old veteran said.

Hubbard props up her leg, careful not to graze it against the kitchen table in her home east of Phoenix. It's red and swollen, still scarred from an ulcer that landed her in the hospital a few months ago.

"That started as a little blister and four days later it was like the size of a baseball," she said. "They had to cut it open and then it got infected, and because I have blood flow issues, it doesn't heal."

She knows it's likely to happen again.

"Over the past three years, I've been prescribed over 60 different medications and combinations; none have even touched the pain," she said.

Hubbard said she's had injections and even traveled across the country for infusions of ketamine, an anesthetic that can be used for pain in extreme cases. Her doctors have discussed amputating her leg because of the frequency of the infections.

"All I can do is manage the pain," she said. "Opioids have become the best solution."

For about nine months, Hubbard was on a combination of short- and long-acting opioids. She said it gave her enough relief to start leaving the house again and do physical therapy.

But in April that changed. At her monthly appointment, her pain doctor informed her the dose was being lowered. "They had to take one of the pills away," she said.

Hubbard knew the rules were part of Arizona's new opioid law, which places restrictions on prescribing and limits the maximum dose for most patients. She also knew the law wasn't supposed to affect her — an existing patient with chronic pain.

Hubbard argued with the doctor, without success. "They didn't indicate there was any medical reason for cutting me back. It was simply because of the pressure of the opioid rules."

Her dose was lowered from 100 morphine milligram equivalents daily (MME) to 90, the highest dose allowed for many new patients in Arizona. She said her pain has been "terrible" ever since.

"It just hurts," she said. "I don't want to walk, I pretty much don't want to do anything."

Hubbard's condition may be extreme, but her situation isn't unique. Faced with skyrocketing drug overdoses, states are cracking down on opioid prescribing. Increasingly, some patients with chronic pain like Hubbard say they are becoming collateral damage.

New Limits On Prescribing

More than two dozen states have implemented laws or policies limiting opioid prescriptions in some way. The most common is to restrict a patient's first prescription to a number of pills that should last a week or less. But some states like Arizona have gone further by placing a ceiling on the maximum dose for most patients.

The Arizona Opioid Epidemic Act, the culmination of months of outreach and planning by state health officials, was passed earlier this year with unanimous support.

It started in June 2017, when Arizona Gov. Doug Ducey, a Republican, declared a public health emergency, citing new data, showing that two people were dying every day in the state from opioid overdoses.

He has pledged to come after those responsible for the rising death toll.

"All bad actors will be held accountable — whether they are doctors, manufacturers or just plain drug dealers," Ducey said in his annual State of the State address, in January 2018.

The governor cited statistics from one rural county where four doctors prescribed 6 million pills in a single year, concluding "something has gone terribly, terribly wrong."

Later in January, Ducey called a special session of the Arizona legislature and in less than a week he signed the Arizona Opioid Epidemic Act into law. He called it the "most comprehensive and thoughtful package any state has passed to address this issue and crisis to date."

The law expands access to addiction treatment, ramps up oversight of prescribing and protects drug users who call 911 to report an overdose from prosecution, among other things.

Initially, Arizona's major medical associations cautioned against what they saw as too much interference in clinical practice, especially since opioid prescriptions were already on the decline.

Gov. Ducey's administration offered assurances that the law would "maintain access for chronic pain sufferers and others who rely on these drugs." Restrictions would apply only to new patients. Cancer, trauma, end-of-life and other serious cases were exempt. Ultimately, the medical establishment came out in favor of the law.

Pressure On Doctors

Since the law's passage, some doctors in Arizona report feeling pressure to lower patient doses, even for patients who have been on stable regimens of opioids for years without trouble.

Dr. Julian Grove knows the nuances of Arizona's new law better than most physicians. A pain doctor, Grove worked with the state on the prescribing rules.

"We moved the needle to a degree so that many patients wouldn't be as severely affected," said Grove, president of the Arizona Pain Society. "But I'll be the first to say this has certainly caused a lot of patients problems [and] anxiety."

"Many people who are prescribing medications have moved to a much more conservative stance and, unfortunately, pain patients are being negatively affected."

Like many states, Arizona has looked to its prescription-monitoring program as a key tool for tracking overprescribing. State law requires prescribers to check the online database. Report cards are sent out comparing each prescriber to the rest of their cohort. Clinicians consider their scores when deciding how to manage patients' care, Grove said.

"A lot of practitioners are reducing opioid medications, not from a clinical perspective, but more from a legal and regulatory perspective for fear of investigation," Grove said. "No practitioner wants to be the highest prescriber."

Arizona's new prescribing rules don't apply to board-certified pain specialists like Grove, who are trained to care for patients with complex chronic pain. But, said Grove, the reality is that doctors — even pain specialists — were already facing pressure on many fronts to curtail opioids — from the Drug Enforcement Agency to health insurers down to state medical boards.

The new state law has only made the reduction of opioids "more fast and furious," he said.

Grove traces the hypervigilance back to guidelines put out by the Centers for Disease Control and Prevention in 2016. The CDC spelled out the risks associated with higher doses of opioids and advised clinicians when starting a patient on opioids to prescribe the lowest effective dosage.

Psychiatrist Sally Satel, a fellow at the American Enterprise Institute, said those guidelines stipulated the decision to lower a patient's dose should be decided on a case-by-case basis, not by means of a blanket policy.

"[The guidelines] have been grossly misinterpreted," Satel said.

The guidelines were not intended for pain specialists, but rather for primary care physicians, a group that accounted for nearly half of all opioids dispensed from 2007 to 2012.

"There is no mandate to reduce doses on people who have been doing well," Satel said.

In the rush to address the nation's opioid overdose crisis, she said, the CDC's guidelines have become the model for many regulators and state legislatures. "It's a very, very unhealthy, deeply chilled environment in which doctors and patients who have chronic pain can no longer work together," she said.

Satel called the notion that new prescribing laws will reverse the tide of drug overdose deaths "misguided."

The rate of opioid prescribing nationally has declined in recent years, though it still soars above the levels of the 1990s. Meanwhile, more people are dying from illicit drugs like heroin and fentanyl than prescription opioids.

In Arizona, more than 1,300 people have died from opioid-related overdoses since June 2017, according to preliminary state numbers. Only a third of those deaths involved just a prescription painkiller.

Heroin is now almost as common as oxycodone in overdose cases in Arizona.

A Range Of Views

Some physicians support the new rules, said Pete Wertheim, executive director of the Arizona Osteopathic Medical Association.

"For some, it has been a welcome relief," he said. "They feel like it has given them an avenue, a means to confront patients." Some doctors tell him it's an opportunity to have a tough conversation with patients they believe to be at risk for addiction or overdose because of the medication.

The organization is striving to educate its members about Arizona's prescribing rules and the exemptions. But, he said, most doctors now feel the message is clear: "We don't want you prescribing opioids."

Long before the law passed, Wertheim said, physicians were already telling him that they had stopped prescribing, because they "didn't want the liability."

He worries the current climate around prescribing will drive doctors out of pain management, especially in rural areas. There's also a fear that some patients who can't get prescription pills will try stronger street drugs, said Dr. Gerald Harris II, an addiction treatment specialist in Glendale, Ariz.

Harris said he has seen an increase in referrals from doctors concerned that their patients with chronic pain are addicted to opioids. He receives new patients — almost daily, he said — whose doctors have stopped prescribing altogether.

"Their doctor is afraid and he's cut them off," Harris said. "Unfortunately, a great many patients turn to street heroin and other drugs to self-medicate because they couldn't get the medications they need."

Arizona's Department of Health Services is working to reassure providers and dispel the myths, said Dr. Cara Christ, who heads the agency and helped design the state's opioid response. She pointed to the recently launched Opioid Assistance and Referral Line, created to help health care providers with complex cases. The state has also released a set of detailed prescribing guidelines for doctors.

Christ characterizes this as an "adjustment period" while doctors learn the new rules.

"The intent was never to stop prescribers from utilizing opioids," she said. "It's really meant to prevent a future generation from developing opioid use disorder, while not impacting current chronic pain patients."

Christ said she just hasn't heard of many patients losing access to medicine.

It's still too early to gauge the law's success, she said, but opioid prescriptions continue to decline in Arizona.

Arizona saw a 33 percent reduction in the number of opioid prescriptions in April, compared with the same period last year, state data show. Christ's agency reports that more people are getting help for addiction: There has been about a 40 percent increase in hospitals referring patients for behavioral health treatment following an overdose.

Shannon Hubbard, the woman living with complex regional pain syndrome, considers herself fortunate that her doctors didn't cut back her painkiller dose even more.

"I'm actually kind of lucky that I have such a severe case because at least they can't say I'm crazy or it's in my head," she said.

Hubbard is well aware that people are dying every day from opioids. One of her family members struggles with heroin addiction and she's helping raise his daughter. But she's adamant that there's a better way to address the crisis.

"What they are doing is not working. They are having no effect on the guy who is on the street shooting heroin and is really in danger of overdosing." she said. "Instead they are hurting people that are actually helped by the drugs."

Some Doctors, Patients Balk At Medicare's 'Flat Fee' Payment Proposal

KFF Health News, July 31, 2018

Many doctors predict that the proposed payment changes would establish a financial incentive to see fewer Medicare patients.

This article first appeared July 31, 2018 on Kaiser Health News.

By Martha Bebinger, WBUR

The Trump administration announced a plan Friday that would affect about 40 percent of the payments physicians receive from Medicare. Not everybody's pleased.

The Centers for Medicare & Medicaid Services calls its proposed plan a historic effort to reduce paperwork and improve patient care. But some doctors and advocates for patients fear it could be a disaster.

The CMS plan, published in Friday's Federal Register, is now open for public comment until early September. It would combine four levels of paperwork required for reimbursement, and four levels of payments, into one form and one flat fee for each doctor's appointment (although there would still be separate filing systems for new and established patients).

In a letter previewing the plan to doctors earlier this month, CMS Administrator Seema Verma said that physicians waste too much time on mindless administrative tasks that take time away from patients.

"We believe you should be able to focus on delivering care to patients," Verma wrote, "not sitting in front of a computer screen."

Initially, that sounded pretty good to Dr. Angus Worthing, a rheumatologist in Washington, D.C. Then he tested the claim with his own analysis.

During a typical 15- to 45-minute appointment with a patient, Worthing figured, "I might spend one to two minutes less in front of the computer, documenting and typing."

Dr. Kate Goodrich, CMS' chief medical officer, noted that "saving one to two minutes per patient adds up pretty quickly over time."

But Worthing said the small savings in time is not worth the reduced payment he'd get. The CMS plan would offer a flat fee for each office visit with a patient, whether the doctor is a primary care physician or a specialist.

Rheumatologists, in general, could expect a 3 percent reduction in Medicare's reimbursement because they typically see and bill for more complicated patients, said Worthing, who chairs the government affairs committee for the American College of Rheumatology.

And he noted that his personal net income from Medicare patients would drop even more — by about 10 percent. That's because 70 percent of his costs — for rent, payroll and other expenses — are fixed or rising.

Worthing is leading efforts by rheumatologists to persuade CMS to adjust its funding formula before the plan goes into effect in January.

"The proposal is well-intentioned but it might cause a disaster," he said, if it leads to fewer medical students going into rheumatology and other specialties that require doctors to manage complex patients. And physicians might stop taking Medicare patients altogether, or avoid those with more difficult problems.

Al Norman, a 71-year-old Medicare patient, said he can see that disaster coming.

"If you're frail or if you are very healthy, you're worth the same to a doctor [under the proposed plan], and obviously that means that the people who are more disabled or frail are less desirable patients," said Norman, who worked on elder care issues in Massachusetts before retiring last year.

Many doctors predict that the proposed payment changes would establish a financial incentive to see fewer Medicare patients. Goodrich, the Medicare official, disagrees.

"That's an unintended consequence we wanted to mitigate on the front end and avoid," Goodrich said. Under the proposed system, doctors who need more time with patients could file for an "add-on" payment of $67 per appointment. That would require a small amount of additional documentation, she admitted, but would still reduce a doctor's keyboard time, according to CMS estimates.

This "add-on" payment is "intended to ensure that physicians are being appropriately compensated for seeing the most complex patients," Goodrich said.

Still, critics of the plan say there are other unintended consequences CMS may not have anticipated.

Dr. Paul Birnbaum, who has been practicing dermatology in the Boston area for 32 years, said he's worried that paying doctors a reduced fee per appointment would translate to lots of short visits.

"You would just see more people," Birnbaum said. "You'd move people through faster. And so you have somebody come back for repeat office visits. And that, over time, would be inflationary."

More frequent trips to the doctor would mean more copays for patients and higher costs for Medicare, he said.

The Trump administration is not suggesting the payment changes would save Medicare money. In her letter to doctors, Verma said some physicians would see their Medicare payments increase.

And it's not just doctors who treat elderly patients who are likely to be affected. If the Medicare payment changes take effect, private insurers might follow suit, in part because it's easier for all insurers to use common billing procedures.

Theoretically, obstetrician-gynecologists would be among the biggest winners; they treat fewer complex Medicare patients. Still, many OB-GYNs are worried about the coming changes, too.

"There will be winners and losers, and my real fear is it's not the physicians [who will lose the most]. My real fear is that it's the Medicare beneficiaries," said Dr. Barbara Levy, vice president for health policy at the American College of Obstetricians and Gynecologists.

Some Medicare advocates are urging CMS to postpone these changes and consider a trial run.

"If we're going to talk about this kind of wholesale, large-scale reconfiguration of the way reimbursement is given to doctors," said Joe Baker, president of the Medicare Rights Center, "it's probably best to do that in a demonstration project where we can closely study the ramifications."

CMS hopes to enact any changes to Medicare fee schedules on Jan. 1, 2019.

The main challenge remains convincing patients and physicians that the changes are worth doing in the first place.

Medicare Reconsiders Paying For Seniors' Spine Operations At Surgery Centers

KFF Health News, July 30, 2018

The plan to re-evaluate the decision to pay for seniors’ spine procedures was announced last week in Medicare’s OPPS proposal for 2019.

This article first appeared July 30, 2018 on Kaiser Health News.

By Christina Jewett

Medicare is reviewing whether seniors should undergo spine surgeries at same-day surgery centers, the government-run health program announced Wednesday, five months after a USA Today Network-Kaiser Health News investigation revealed a spate of patient deaths following the procedures.

The proposal states that Medicare officials will examine whether these procedures "pose a significant safety risk" to patients and continue to "meet the criteria" for Medicare payment.

The news investigation found that in 2015 and in 2017 Medicare approved same-day spine operations for seniors even though at least 14 patients had died since 2008 after such procedures.

Some suffocated from a well-known complication of upper-spine surgery that can generally be reversed if caught immediately and treated properly.

The investigation also found that some medical professionals urging Medicare to pay surgery centers to operate on seniors' spines failed to mention recent incidents of death at their own or an affiliated facility.

Dr. Nancy Epstein, a chief of neurosurgical and spine education at New York University Winthrop Hospital, lauded the proposal, saying patients face extensive risks after spine surgery.

"It's about time," Epstein said of the review proposal, which she expects to rankle some doctors who have a financial stake in a spine surgery center.

Bill Prentice, executive director of the Ambulatory Surgery Center Association, which represents the centers in policymaking discussions, said he supports Medicare stepping up its efforts to perform an internal and external review of the procedures it pays for at surgery centers.

"The more resources they use, the better," Prentice said. "I think that the more data points they have, the more likely they are to make the right decision. … We believe these procedures can be performed very safely in the ambulatory surgery center space."

Medicare announced the plan to re-evaluate its decision to pay for seniors' spine procedures in an annual rule-making document released Wednesday. The agency is accepting comments on the proposed changes through Sept. 24 and is expected to release a final decision late in the year.

The nation's 5,600-plus Medicare-certified surgery centers are required to have an internal governing body that decides which surgeries it will perform on the center's patients. However, the federal agency decides which operations it will pay for in surgery centers, continuously proposing and adding some procedures during annual rule-making.

The recent proposal aims to review 38 procedures added since 2015, of which 25 involve spine surgery, and create an ongoing plan to continually review approved procedures. The proposal says that because "Medicare beneficiaries tend to be frailer and exhibit a higher number of comorbidities than other populations, we believe it may be appropriate to reevaluate recently-added procedures."

The proposal also says Medicare will use "all available data," "prevailing medical practice" and any public comments it receives to assess whether to keep paying for the procedures.

The USA Today-KHN investigation, involving reporters based in California, Indiana, Florida and New Jersey, included a review of thousands of pages of lawsuits, state records and Medicare's own inspection reports. It found that spinal surgery patients suffered tragic complications in surgery centers or soon after they left.

The cases include a Florida man, then 53, whose doctors left soon after an upper-spine surgery. Soon afterward, he had difficulty breathing. A nurse called 911, and paramedics who rushed to the surgery center initially hit a locked door, the family's lawsuit says. The man remains in a vegetative state.

A California woman, Paulina Tam, 56, told a nurse she was having trouble breathing after her upper-spine surgery, a Medicare inspection report says. Her medical team had also left for the day. The doctor who happened to be at the center after 6 p.m. later told a state inspector he "wasn't prepared" to perform an emergency surgery to insert an airway through the front of her throat. Tam died the following morning.

Her son, Dr. Eric Tam, a New York City physician, said Medicare's proposal is "overall very good news — someone is looking into something at least."

However, he said one concern about the effort is that "I'm not really sure how much data they have to examine."

Health databases for many under-65 patients would make it difficult to link injuries that happen after a patient leaves a surgery center. The investigation found court records showing that some upper-spine surgery patients developed fatal complications the day they left a surgery center.

They include a San Diego man whose wife said he gasped "like a fish" waiting for an ambulance after his surgery in 2016, a Dallas man who collapsed in his father's arms in a similar scenario in 2011 and a Portland man who pounded the roof of a car as his wife sped to the hospital.

None of them survived.

In emails sent last year, Medicare officials said when they approved similar spine surgeries for seniors, they did not get any public comments that the procedures would put patients at risk.

Dr. Tony Asher, director of the national neurosurgery quality and outcomes database who is also a surgery center association board member, acknowledged that he was "appalled" by some cases in the news investigation.

He said spine surgeons need to embrace more transparency on safety outcomes related to specific procedures — and specific surgery centers.

"In an optimal setting, it is possible to do these things effectively and safely," he said. "On an ongoing basis, we have to show we are providing that."

Drug Trade Group Quietly Spends 'Dark Money' To Sway Policy And Voters

KFF Health News, July 30, 2018

PhRMA donated $6.1 million in 2016 to the American Action Network, which ran anti-ACA TV ads in 75 congressional districts.

This article first appeared July 30, 2018 on Kaiser Health News.

By Jay Hancock

In 2010, before the Affordable Care Act was passed by Congress, the pharmaceutical industry's top lobbying group was a very public supporter of the measure. It even helped fund a multimillion-dollar TV ad campaign backing passage of the law.

But last year, when Republicans mounted an aggressive effort to repeal and replace the law, the group made a point of staying outside the fray.

"We've not taken a position," said Stephen Ubl, head of the organization, the Pharmaceutical Research and Manufacturers of America, known as PhRMA, in a March 2017 interview.

That stance, however, was at odds with its financial support of another group, the American Action Network, which was heavily involved in that effort to put an end to the ACA, often referred to as Obamacare, spending an estimated $10 million on an ad campaign designed to build voter support for its elimination.

"Urge him to repeal and replace the Affordable Care Act now," one ad running in early 2017 advised viewers to tell their congressman. That and similar material (including robocalls) paid for by the American Action Network ran numerous times last year in 75 congressional districts.

PhRMA was one of AAN's biggest donors the previous year, giving it $6.1 million, federal regulatory filings show. And PhRMA had a substantial interest in the outcome of the repeal efforts. Among other actions, the GOP-backed health bill would have eliminated a federal fee paid by pharmaceutical companies, one estimated at $28 billion over a decade.

But there was no way the public could have known at the time about PhRMA's support of AAN or the identity of other deep-pocketed financiers behind the group.

Unlike groups receiving its funds, PhRMA and similar nonprofits must report the grants in their own filings to the Internal Revenue Service. But the disclosures don't occur until months or sometimes more than a year after the donation.

The conservative-leaning AAN has become one of the most prominent nonprofits for funneling "dark money" — difficult-to-trace funds behind TV ads, phone calls, grass-roots organizing and other investments used to influence politics. Such groups have thrived since the Supreme Court's Citizens United decision in 2010, which loosened rules for corporate political spending, and amid what critics say is nonexistent policing of remaining rules by the IRS.

(It's impossible to know from public records whether PhRMA donated before or after President Donald Trump's victory, which made repealing the health law a substantial possibility. In any case, most donations to dark-money groups are not earmarked for a particular program.)

Generally speaking, dark-money groups are politically active organizations, often nonprofits, that are not required to disclose identities of their donors. Under IRS regulations, donors may fund a nonprofit group such as AAN, which is allowed to engage in political activities and is not required to reveal its funding sources.

Dark-money groups are often chartered under Section 501(c)(4) of the tax law, which grants tax exemption to "social welfare organizations." For those seeking to influence politics but stay in the background, 501(c)(4) designations offer two big advantages: tax exemption and no requirement to disclose donors.

Against the backdrop of high drug prices and its heaviest political expenditures in years, the pharmaceutical industry is directing substantial resources through AAN and other such groups that hide the identity of their donors and have few if any limits on fundraising.

"PhRMA has always been very aggressive and very effective in their influence efforts," said Michael Beckel, research manager at Issue One, a nonprofit devoted to campaign-finance transparency. "That includes using these new, dark-money vehicles to influence policy and elections."

PhRMA's $6.1 million, unrestricted donation to AAN was its single-biggest grant in 2016, dwarfing its $130,000 contribution to the same group the year before. Closely associated with House Republicans — AAN has a former Republican senator and two former Republican House members on its board — the group backed the failed GOP health bill intended to replace the Affordable Care Act. It also supported the successful Tax Cuts and Jobs Act of 2017, which reduced corporate taxes by hundreds of billions of dollars over a decade.

So far in this election cycle, AAN has given more than $19 million to the Congressional Leadership Fund, a Republican super PAC with which it shares an address and staff, according to the Center for Responsive Politics. The fund recently ran ads opposing Democratic candidates in high-profile special congressional elections in Georgia and Pennsylvania.

PhRMA disputes the suggestion that it backs particular actions by the recipients of its donations. "PhRMA engages with groups and organizations that have a wide array of health care opinions and policy priorities," said its spokesman, Robert Zirkelbach. "It is inaccurate and would be inappropriate for you to attribute those grants to a specific campaign."

AAN declined several requests for comment.

Including AAN, PhRMA gave nearly $10 million in 2016 to politically active groups that don't have to disclose donors, its most recent filing with the IRS shows. By contrast, PhRMA and its political action committee, or PAC, made only about $1 million in comparatively transparent political donations in 2015 and 2016 that were disclosed to regulators and reported by the Center for Responsive Politics.

PhRMA's 2016 political activities included support for the Republican National Convention. Rather than directly support the Cleveland convention, which several companies pulled out of after it became clear that Donald Trump was going to be the presidential nominee, PhRMA routed $150,000 through limited liability companies with names like Convention Services 2016 and Friends of the House 2016.

Like 501(c)(4)s, LLCs do not have to disclose their donors. PhRMA's support was revealed in IRS filings more than a year later. (Donations by PhRMA and other groups to Friends of the House, which financed a luxury lounge for convention dignitaries, were first reported by the Center for Public Integrity last fall.)

PhRMA's surge in donations to AAN coincides with the arrival of Ubl, who took over as president and CEO in 2015 and has long-standing ties to Norm Coleman, a former U.S. senator from Minnesota who is now AAN's chairman. Ubl once ran the lobby for makers of knee implants, heart stents and other medical devices, one of whose most powerful members, Medtronic, is based in Minneapolis.

Dues paid by member drug companies rose by 50 percent after he got there. PhRMA's total revenue increased by nearly a fourth in 2016, according to IRS filings.

PhRMA's 2016 dark-money contributions included $150,000 to Americans for Prosperity, a conservative group associated with billionaires Charles and David Koch. Their group has already signaled it will be active in November's elections, running attack ads against Sen. Jon Tester, a vulnerable Montana Democrat, for not supporting ACA repeal.

PhRMA also gave $50,000 to Americans for Tax Reform, run by conservative anti-tax activist Grover Norquist.

PhRMA and other trade associations donate to such groups "to avoid attracting attention" amid the political fray, said Bruce Freed, president of the Center for Political Accountability, which seeks to shed light on corporate political spending. Nevertheless "they're achieving their goals by giving money to these folks and helping elect members that are going to be in support of them."

Mostly smaller amounts went to centrist and liberal groups. Center Forward, which claims to seek bipartisan, common ground on drug policy and other issues, got $300,000 directly from PhRMA and another $179,000 from a PhRMA-backed group called the Campaign for Medical Discovery, according to tax filings.

Zirkelbach disputed the notion that PhRMA donations to AAN and other groups were intended to achieve specific goals, saying, "We seek to work with organizations we agree with as well as those where we have disagreements on public policy issues."

Much of the work by PhRMA-linked, dark-money groups touches health policy and harmonizes with PhRMA's positions.

During debates over the tax overhaul, Center Forward worked to preserve a tax credit for researching rare-disease medicines known as orphan drugs. PhRMA took a similar stance, encouraging Congress "to maintain incentives" for rare-disease drugs.

AAN, which collected total contributions and grants of $14.6 million for fiscal 2016, launched a $2.6 million mass-mailing and ad campaign against letting Medicare lower drug prices through negotiations. PhRMA supported that stance, telling Healthline that such a measure could jeopardize seniors' access to medicine and discourage companies from developing drugs.

Americans for Tax Reform ran similar ads in local markets opposing "price controls" on prescription drugs.

PhRMA's dark-money allies push its agenda without disclosing its role, critics say.

PhRMA is "spending millions of dollars on politics every cycle, and they're splitting it up between the state and federal level," said Robert Maguire, political nonprofits investigator for the Center for Responsive Politics, which tracks political donations. "They're just not running the political ads themselves," which keeps their name off the product, he said.

A group called Caregiver Voices United, which got $720,000 from PhRMA in 2016, backed a secret effort to generate letters opposing a drug-transparency bill in Oregon. The campaign surfaced when an employee leaked phone-script documents to a lawmaker, as reported in February by The Register-Guard newspaper in Eugene.

Caregiver Voices United is "not influenced" by PhRMA or any other outside group, said John Schall, its president.

Dark-money groups received pharmaceutical industry money from individual companies as well, not just the PhRMA trade organization.

In 2016, Amgen gave $7,500 to Third Way, a center-left group that supports reimbursement for drugs and medical devices based on their results, according to the Center for Political Accountability. Johnson & Johnson gave $35,000 that year to the Republican Main Street Partnership, a 501(c)(4) that describes itself as a coalition of lawmakers committed to "conservative, pragmatic government," the CPA data show.

But CPA's research also reveals that many pharmaceutical companies don't disclose donations made to 501(c)(4) organizations, nor are they legally required to.

Corporations "could dump millions into one of these (c)(4)s and nobody would ever know where it came from," said Steven Billet, a former AT&T lobbyist who teaches PAC management at George Washington University.

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