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On August 26, Judge Thad Balkman delivered a $572 million judgment against pharmaceutical giant Johnson & Johnson for the company’s role in fueling the opioid epidemic in Oklahoma. In the discussion that follows, Stanford Law Professors Michelle Mello and Nora Freeman Engstrom discuss the decision and how other cases tied to the national opioid crisis are developing.

The Oklahoma decision took many onlookers by surprise. How did the case unfold? And what did Judge Balkman find? On Monday, Cleveland County District Judge Thad Balkman of Oklahoma issued a judgment that capped off a long and closely-scrutinized trial wherein the Oklahoma Attorney General faced off against Johnson & Johnson (J&J), claiming that J&J contributed to the opioid epidemic that has devastated the state of Oklahoma.

 

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Stanford Law Professors Michelle Mello and Nora Freeman Engstrom

To understand the verdict, a bit of background is helpful. When Oklahoma initially sued, it cast the net broadly, asserting claims against several defendants under several causes of action.  Certain defendants (namely, Purdue and Teva) chose to settle rather than roll the dice at trial. (Purdue, the maker of OxyContin, agreed to pay Oklahoma $270 million and Teva, one of the world’s leading providers of generic drugs, $85 million; neither admitted wrongdoing.)  Further, over time, Oklahoma’s various causes of action got winnowed down to the singular claim that J&J had created a public nuisance by aggressively and deceptively marketing opioid products to Oklahoma’s doctors and patients.  This posture meant that Oklahoma’s victory at trial was far from a foregone conclusion, as public nuisance claims can be very hard to prove, particularly in cases that relate to dangerous products.

With that table set, the trial began on May 28, 2019.  In a crowded courtroom in Cleveland County, it stretched on for nearly seven weeks and featured dozens of witnesses and more than 800 exhibits. The trial was a bench trial, meaning there was no jury, but there was a written opinion explaining the judge’s decision.  Judge Balkman’s 42-page opinion offers a cogent summary of the evidence and governing law and, broadly, vindicates Oklahoma’s litigation strategy. The opinion finds that J&J engaged in a deceptive marketing campaign designed to convince Oklahoma doctors and the public that opioids were safe and effective for the long-term treatment of chronic, non-malignant pain. Further, this “false, misleading, and dangerous marketing” caused “exponentially increasing rates of addiction [and] overdose death,” which ravaged the Sooner State. The picture Judge Balkman draws is stark and, for J&J, devastating.

Are individuals suing drug companies too? Are there class action cases that are relevant?

There are some suits by individuals, but we don’t believe that’s where the big money damages—and the real social impact of the litigation—will be.  More important is the pending federal multi-district litigation (MDL), which consolidates nearly 2,000 individual federal lawsuits brought by cities, counties, municipalities, and tribal governments in a single action before Judge Dan Polster in Cleveland, Ohio. Additionally, 48 states have initiated separate litigation, with a lineup of claims and defendants similar to the MDL.

Does this win for Oklahoma mean these other plaintiffs have an easy road ahead?

Not easy, but potentially easier. The Oklahoma case is what we call a bellwether. Like the ram that leads the other sheep this way or that, the bellwether trial doesn’t control the path of future litigation. But it does go first, and it helps to indicate trends.

As a bellwether, the big verdict here is very reassuring to the many states, counties, municipalities, and tribes suing opioid makers, distributors, and retailers, and it is, correspondingly, very disturbing for those who made and sold opioids to the American public.  The verdict suggests that this litigation has legs, and that judges and juries may be willing to pin blame not just on Purdue, the maker of OxyContin, but on others who played an arguably less central role in fueling this public health crisis.

What is striking is how damning Judge Balkman’s factual conclusions about J&J’s conduct are, and how similar they are to the allegations made against other opioid manufacturers in other cases.  All the things he objected to regarding J&J’s marketing practices are things that others, too, allegedly have done. Some of them are things that multiple companies banded together to do. Plaintiffs’ attorneys should be feeling pretty confident about their chances of persuading other courts that those practices are problematic.

Is Oklahoma free to use the award as it wishes? Will the state share some of the award with the people who died or suffered in the opioid crisis (if the decision is upheld on appeal)?

The damages, in this case, are intended to fund Oklahoma’s “nuisance abatement plan.”  That’s the remedy in a public nuisance case: The defendant has to pay to clean up the mess it made. In this case, Oklahoma provided a detailed plan laying out what would be needed to abate the opioid problem in the state. The costs added up to $572 million for the first year, and that’s what the judge awarded—not the $17 billion Oklahoma sought for a multi-year abatement effort.

The plan specifies that the money will be used for opioid use disorder screening, prevention and treatment ($292 million), housing and other services for those in recovery ($32 million), continuing medical education programs ($108 million), a pain management benefit program ($103 million), treatment of neonatal abstinence syndrome ($21 million), and other services.  Individuals won’t be direct recipients of the funds, though they may receive the services funded.

Legally, what happens next?

J&J has vowed to appeal the “flawed” Oklahoma judgment, and we expect that the judgment will be appealed, first to Oklahoma’s intermediate, and then, likely, to its supreme, court.  More immediately, though, attention will turn from Oklahoma to Ohio.  The first bellwether trial in the MDL, involving claims from Ohio’s Cuyahoga and Summit counties, is scheduled to begin on October 21.

Even as they prepare for trial, however, lawyers for both plaintiffs and defendants are also, no doubt, continuing to work toward reaching a broad and encompassing settlement.  When Judge Polster was first assigned the MDL back in January 2018, he made no bones about his desire to do “something meaningful to abate this crisis”—and to do it quickly.  It hasn’t been easy to execute on that, which isn’t surprising given the unprecedented magnitude and complexity of the litigation.

Still, we expect that, sooner or later, the opioid litigation will settle.  Indeed, even as we write, news is breaking that Purdue and the Sacklers may be in the midst of a negotiation whereby Purdue would declare bankruptcy and the Sacklers would contribute a cash payment of roughly $4.5 billion-plus relinquish ownership of the company, in return for peace with plaintiffs.

But even forging a settlement involving just those two entities is tricky—and forging a broader settlement will be exponentially harder for a number of reasons.  One is that any truly global agreement needs to pass muster with a range of defendants, some of whom have comparatively shallow pockets, and all of whom sold (or made or distributed) different products, at different times, in different quantities, in different states.  And, on the other side of the table, any settlement agreement needs to get buy-in from both those plaintiffs in the MDL and also state attorneys’ general, who have their own distinct set of priorities and interests relating to their separate lawsuits.  Further, because only a small proportion of eligible cities and counties have joined the MDL to date, any global settlement needs to somehow—equitably but firmly—close the courthouse door on those potential future plaintiffs.  None of this will be easy to accomplish.  But whenever new information reduces uncertainty about how courts would resolve a legal dispute, settlement becomes more likely—and, here, the Oklahoma verdict makes a significant contribution.

 

Nora Freeman Engstrom, Professor of Law and Deane F. Johnson Faculty Scholar, is a nationally-recognized expert in tort law, legal ethics, and complex litigation. Her work explores the day-to-day operation of the tort system—particularly its interaction with alternative compensation mechanisms. Michelle Mello, Professor of Law and Professor of Health Research and Policy (School of Medicine), is a leading empirical health scholar and the author of more than 150 book chapters and articles, including “Drug Companies’ Liability for the Opioid Epidemic,” recently published in the New England Journal of Medicine.  

 

 

 

 

 

 

 

 

 

 

 

 

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A task force of national health experts has released a draft recommendation to screen all adults 18 to 79 years for the hepatitis C virus (HCV), noting the opioid epidemic has fueled what has become the most common chronic bloodborne pathogen in the United States.

Cases of acute HCV have increased 3.5-fold over the last decade, particularly among young, white, injection drug users who live in rural areas. Women aged 15 to 44 have also been hit hard by the virus that is spread through contaminated blood.

The U.S. Preventive Services Task Force, which makes recommendations followed by primary care clinicians nationwide, has until now recommended that people who are at high risk be tested for hepatitis C, as well as “baby boomers” born between 1945 and 1965.

“Unfortunately, HCV now affects a broader age range than previously with three times as many new infections per year,” said Stanford Health Policy’s Douglas K. Owens, chair of the independent, voluntary panel of national experts in prevention and evidence-based medicine.

The Task Force now recommends that clinicians encourage all their adult patients, even those with no symptoms or known liver disease, get a blood test for the virus. Pregnant women should also be screened; from 2009 to 2014, the prevalence of HCV infection among women giving birth has nearly doubled.

“The explosive growth in HCV has been fueled by the opioid epidemic, with the spread of HCV into younger populations,” said Owens, director of the Center for Health Policy and the Center for Primary Care and Outcomes Research. “HCV now kills more Americans than all other reportable infectious diseases combined, including HIV.”

An estimated 4.1 million people in the United States are carrying HCV antibodies; about 2.4 million are living with the virus, according to the Task Force. The HCV infection becomes chronic in 75% to 85% of cases and some of those people develop symptoms such as chronic fatigue and depression, and liver diseases that can range from cirrhosis to liver cancer.

Approximately one-third of people ages 18 to 30 who inject drugs are infected with the virus; 70% to 90% of older injection-drug users are infected.

There currently is no vaccine for hepatitis C although research in the development of a vaccine is underway. But there are effective oral direct-acting antiviral (DAA) medications that can clear the virus from the body, particularly if caught early.

“The good news is that treatment for HCV is far better, and far better tolerated than in the past, offering a cure to most people,” Owens said. “Early identification of HCV is important to prevent long-term complications of HCV including liver failure, liver cancer, and death.”

The Task Force said in a release that there are several key research gaps that could inform the benefit of screening for HCV infection:

  1. ·     Research is needed on the yield of repeat vs. one-time screening for HCV.
  2. ·     Research is needed to identify labor management practices and treatment of HCV infection prior to pregnancy to reduce the risk of mother-to-child transmission.
  3. ·     Trials and cohort studies that measure effects on quality of life, function, and extrahepatic effects of HCV infection (such as renal function, cardiovascular effects or diabetes) would be helpful for evaluating the impact of DAA regimens on short-term health outcomes.
  4. ·     Additional studies are needed to examine the epidemiology of HCV infection and the effectiveness of DAA regimens in adolescents.

 

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Surprise, out-of-network charges billed to privately insured Americans who received inpatient care at in-network hospitals more than doubled between 2010 and 2016, according to a study by researchers at the Stanford University School of Medicine.

Many have heard the stories of patients hit with massive, unexpected medical bills after an emergency-room visit or routine surgery, even if that hospital is in their insurance network. News organizations, including Vox.com, have reported on the problem, and both houses of Congress will continue debating draft legislation to tackle unexpected bills after members return from summer recess.

Yet there has been little data-driven research about the financial consequences of out-of-network billing on patients.

 “Our paper is one of the first to spell out just how big the problem really is,” said Eric Sun, MD, PhD, an assistant professor of anesthesiology.

 he paper was published Aug. 12 by JAMA Internal Medicine. Sun is the lead author. The senior author is Laurence Baker, PhD, professor of health research and policy and core faculty member at Stanford Health Policy.

Co-author Michelle Mello, PhD, JD, professor of law and of health research and policy, said news coverage has tended to focus on the real horror stories: patients who got surprise bills for tens or hundreds of thousands of dollars.

“Our study asked what a typical patient who goes to a hospital they’re supposed to go to can expect,” said Mello, who is also a core faculty member at Stanford Health Policy. “And what we found was that although typical out-of-network bills are lower than the horror stories, they’re still high enough to create enormous stress for families — and they’re also really common.”

The authors pointed to a recent survey that found 4 in 10 Americans would not be able to pay an unexpected expense of $400 without selling something or borrowing money. 

Yet the average amount of balance bills sent to patients in the study exceeded that: $2,040 for inpatient admissions and $628 for emergency visits in 2016. Further, 10% of the patients in the study faced an average of  $4,112 for inpatient admissions and $1,364 for ED visits.

Why is this happening?

Mello said there are two potential explanations behind the significant rise in out-of-network bills: insurers may be excluding more physicians from their provider networks, even when they essentially have no choice but to include the hospital; and hospitals may be increasingly tempted to make use of physician staffing groups that have market power and can resist pressure to come in-network at lower rates. 

Balance billing may also occur because insurers pay doctors too little to practice at one given hospital, so to make ends meet, they bill patients directly for additional amounts, Sun said.

“It certainly may be the case that consolidation among insurers has resulted in reduced payments to physicians, and that out-of-network billing is a way to compensate for this,” he said.

The classic example, Sun said, of how surprise billing works can be found at community hospitals that are not run by a multispecialty organization, such as Stanford Health Care or Kaiser Permanente. In that community hospital, everyone is in business for themselves. So, for example, when a patient comes to the emergency department and needs an operation, even if the patient’s chosen surgeon is in-network, all the specialists helping the patient through the surgery may not be. It is often difficult for patients who are in- or out-of-network to walk away if he or she doesn’t like the arrangement, particularly in emergencies.

“The bottom line is this: In a lot of situations, patients can’t choose the doctor, and the doctors can’t choose the patient,” Sun said. “It’s an especially big problem for hospital-based physicians, such as emergency room physicians, anesthesiologists, and radiologists.”

Even if a patient schedules a procedure, such as knee-replacement surgery or the delivery of a baby, accidents or the unknown often occur.

“What if something goes horribly wrong and you have to go to the ICU?” Sun said. “Now everyone seeing you, from the cardiologist or a neurologist, could be out-of-network.”

Crunching the numbers

The researchers examined 5.5 million inpatient admissions and 13.6 million emergency room admissions between 2010 and 2016, using data from the Clinformatics Data Mart, which comprises private health insurance claims from all 50 states from a large commercial insurer. The individuals in the database represent about 19% of all American who have commercial health insurance.

The researchers found the percentage of emergency department visits resulting in one or more out-of-network bills increased from 32.3% to 42.8% and that the average amount billed nearly tripled from $220 to $628. A whopping 85.6% of ambulance rides to emergency departments resulted in an out-of-network bill..

The proportion of inpatient admissions with out-of-network bills increased by almost 60% over that period, from 26.3% to 42%, with the average out-of-network bill more than doubling from $804 to $2,040.

The study found out-of-network billing was common among ambulance services and hospital-based physicians — such as emergency physicians, radiologists and anesthesiologists — providing care at in-network hospitals. “In some circumstances, patients could easily assume that the entire hospital team is in-network and thus the balance billing may come as a surprise,” the authors wrote. “Further, in these contexts, patients may have limited ability to choose.”

The authors note that the findings support current efforts in Congress and the states to limit balance billing in contexts where surprise is likely to be involved. They also note that patients may succeed in getting out-of-network bills reduced in some circumstances.

Still, Mello added: “This is not the way to run a health-care system. Avoiding outrageous bills shouldn’t require a PhD in health policy.” 

The other co-author of the study is Jasmin Moshfegh, a graduate student in the Health Policy PhD program.

 

 

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A new study by Stanford economists shows that giving fathers flexibility to take time off work in the months after their children are born improves the postpartum health and mental well-being of mothers.

In the study, slated for release by the National Bureau of Economic Research on June 3, Petra Persson and Maya Rossin-Slater examined the effects of a reform in Sweden that introduced more flexibility into the parental leave system. The 2012 law removed a prior restriction preventing a child’s mother and father from taking paid leave at the same time. And it allowed fathers to use up to 30 days of paid leave on an intermittent basis within a year of their child’s birth while the mothers were still on leave.

The policy change resulted in some clear benefits toward the mother’s health, including reductions in childbirth-related complications and postpartum anxiety, according to their empirical analysis.

“A lot of the discussion around how to support mothers is about mothers being able to take leave, but we often don’t think about the other part of the equation — fathers,” says Rossin-Slater, an assistant professor of health research and policy.

“Our study underscores that the father’s presence in the household shortly after childbirth can have important consequences for the new mother's physical and mental health,” says Persson, an assistant professor of economics.

Rossin-Slater and Persson are both faculty fellows at the Stanford Institute for Economic Policy Research.

Among their main findings of effects following the reform: Mothers are 14 percent less likely to need a specialist or be admitted to a hospital for childbirth-related complications — such as mastitis or other infections — within the first six months of childbirth. And they are 11 percent less likely to get an antibiotic prescription within that first half-year of their baby’s life.

There is also an overall 26 percent drop in the likelihood of any anti-anxiety prescriptions during that six-month postpartum period — with reductions in prescriptions being most pronounced during the first three months after childbirth.

What’s more, the study found that the average new father used paid leave for only a few days following the reform — far less than the maximum 30 days allowed — indicating how strong of a difference a couple of days of extra support for the mother could make.

“The key here is that families are granted the flexibility to decide, on a day-to-day basis, exactly when to have the dad stay home,” said Persson. “If, for example, the mom gets early symptoms of mastitis while breastfeeding, the dad can take one or two days off from work so that the mom can rest, which may avoid complications from the infection or the need for antibiotics.”

These indirect benefits from giving fathers workplace flexibility are not trivial matters when you consider the health issues mothers often face after childbirth and after they get home from the hospital, says Rossin-Slater, who is also a faculty member of Stanford Health Policy.

Infections and childbirth complications lead to one out of 100 women getting readmitted to the hospital within 30 days in the United States, according to the study.

Meanwhile, postpartum depression occurs for about one out of nine women, and maternal mortality has also been a rising trend over the past 25 years in the U.S.

The study comes as a growing number of lawmakers in the United States vocalize support for paid family leave but have failed to pass federal legislation.

Washington, D.C., and six states have adopted various paid family leave laws, but the U.S. remains the only industrialized nation in the world that does not have a national mandate guaranteeing a certain amount of paid parental leave.

Some federal lawmakers are working on family leave measures and have proposed such legislation over the past few years — including The Family Act, The New Parents Act — but none of them have ever gained enough traction to proceed in Congress.

This new study can help broaden the policy discussions, the researchers say.

The larger context around paid family leave policies is often framed today as a way to help narrow the gender wage gap by giving women more workplace flexibility and fewer career setbacks.

This study, however, shines a light on maternal health costs and how a policy on paid family leave — that includes workplace flexibility for the father — offers more benefits than previously thought, Rossin-Slater says.

“It's important to think not only about giving families access to some leave, but also about letting them have agency over how they use it,” she says.

And when it comes to concerns that fathers might use paid parental leave to goof off instead of spending the time as intended, the researchers say their study should assuage those worries.

“It's not like fathers are going to end up using a whole month to just stay home and watch TV. We don't find any evidence of that,” Rossin-Slater says. “Instead they only use a limited number of days precisely when the timing for that seems most beneficial for the family.”

“For all these reasons,” Persson says, “giving households flexibility in how to use paternity leave makes a lot of sense.”

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Fourteen years ago, Stanford Health Policy’s Douglas K. Owens and colleagues published a cost-effectiveness analysis that would change the face of HIV prevention. Their landmark study in The New England Journal of Medicine showed that expanding HIV screening would increase life expectancy and curb transmission of the disease — and was cost effective in virtually all health-care settings.

Not long after their model-based results were published, their findings became key evidence in the decision to expand screening by the Centers for Disease Control and Prevention. Their work has been used in HIV screening guidelines from the U.S. Preventive Services Task Force — which Owens now chairs — the American College of Physicians and the Department of Veterans Affairs, among others.

Owens and his Stanford colleague Margaret Brandeau, professor of management science and engineering, have led this team of decision scientists who have been at the forefront of developing scientific models for the screening and prevention of HIV for two decades now. This modeling team — which also includes colleagues from UCSF and Yale — has published nearly 250 peer-reviewed studies and is one of the most experienced and respected in the world.

But today, the opioid epidemic is threatening the hard-fought gains in the prevention and control of HIV and hepatitis C virus (HCV). In support of their continued work to address the opioid epidemic, Owens received a highly prestigious MERIT award from the National Institute on Drug Abuse (NIDA),which provides up to 10 years of funding for the team.

“We are extremely grateful to NIDA for this support and to our colleague at NIDA, Dr. Peter Hartsock, who has worked with us for over 20 years to mitigate the harms from HIV and HCV,” said Owens.

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The team will now turn its sights on the complex interplay of the opioid epidemic, and HIV and hepatitis C virus (HCV) transmission. The transmission of HCV has been fueled by the opioid epidemic, and HCV now kills more Americans than all other infectious diseases combined.  

“The unfolding opioid epidemic is a defining challenge for the public health and medical systems in the United States,” Owens, the principal investigator of the team, and his colleagues wrote in their grant proposal. “The reversal of life expectancy growth in the demographic groups most affected by the opioid epidemic represents the aggregation of a complex web of harmful public health and population trends, including a rise in overdoses, suicides, mental health afflictions, economic disadvantages, and infectious disease outbreaks.”

Indeed, for the first time since the 1960s, the U.S. life expectancy has contracted for the second year in a row; drug overdoses have been the leading cause of death for Americans under age 50, with an estimated two-thirds of those deaths resulting from opioids.

Since the last renewal of their NIDA-funding grant in 2013, the team has watched the dramatic rise of opioid overuse, injection drug use, and overdose become a national public health crisis, with more than 60,000 drug overdose deaths in the United States reported by the CDC.

“The growing use of needle-based opioids increases the likelihood of accelerating HIV and HCV transmission,” said co-investigator Jeremy Goldhaber-Fiebert, an associate professor of medicine and core faculty at Stanford Health Policy. “Identifying the best combination of approaches to reduce HIV and HCV transmissions stemming from the opioid epidemic is of critical public health importance.”

The other co-investigators on the team of the project, “Making Better Decisions: Policy Modeling for AIDS and Drug Abuse,” are:

  1. Eran Bendavid, an infectious diseases physician and associate professor of medicine at Stanford who is another a seasoned HIV modeler and outcomes expert;
  2. Keith Humphreys, professor of psychiatry and behavioral sciences at Stanford and a former senior policy advisor in the White House Office of National Drug Control Policy; 
  3. David Paltiel, a Yale School of Public Health professor who pioneered policy options for mitigating the impact of HIV in the United States and abroad;
  4. Gregg Gonsalves, an assistant professor of epidemiology at Yale and a 2018 MacArthur Foundation Fellow who will focus on developing new algorithms to detect and predict opioid-related outbreaks of HIV and HCV;
  5. James Kahn of the Institute for Health Policy Studies at UCSF, professor of epidemiology and biostatistics and an expert on the individual and population impact of prevention and treatment for HIV, HCV and opioid use.

The End of AIDS? 

Toward 2012, a series of scientific advances led to calls for “the end of AIDS.” The two big factors were the cost of the “triple cocktail” of antiretrovirals plunging in developing countries and then huge donations from wealthy countries began pouring in to fight the disease.

Yet the researchers say successes have been too few and that the incidence of HIV remains far too high. About 40 million people were living with HIV around the world in 2017; an estimated 940,000 people died from AIDS-related illnesses that same year.

The year 2015 marked the first time in two decades that the number of HIV diagnoses tied to opioids increased.

"Although it was started by prescription opioid overprescribing, the epidemic has evolved to include significant injection opioid use which is now threatening to significantly increase the spread of infectious diseases like HIV and Hepatitis C,” said Humphreys.

The most visible example of an opioid-related HIV outbreak took place in Scott County, IN, in 2014-2015. A single infection introduced into the community resulted in nearly 200 new HIV cases within six months, largely related to oxymorphone injections. In 2017 and again in March 2018, two additional substantial outbreaks occurred in Scott County, likely linked to both risky sex and needle sharing. 

In addition, the CDC has identified 220 counties in 26 states that are uniquely vulnerable to HIV and HCV outbreaks related to opioid injections.

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“Developing models that forecast high-risk areas for HIV and HCV is essential for aligning surveillance and public health interventions with risk,” said Brandeau, a leader in designing models for the prevention of HIV and hepatitis, especially in drug abuse disorders.

There have also been striking increases in the injection of opioids and heroin that are closely linked to the spread of viral hepatitis. In the demographic areas most affected by opioids, the researchers found, diagnoses of acute hepatitis have more than quadrupled — reversing trends of the previous decade. And in the country as a whole, the number of new HCV cases has nearly tripled since 2010. 

“For any type of contact with an infected source such as a dirty needle, or even cocaine straws, HCV is by far the most rapidly transmissible of the blood-borne infections,” said Bendavid. “One of the challenging issues with hepatitis C is that its major health manifestations do not appear for many years after infection."

What’s the Plan? 

In the next five years, the team intends to evaluate how strategies to prevent and mitigate the harms of opioid use can decrease the spread of HIV and HCV and thereby reduce morbidity and mortality from opioid use. They have four specific goals: 

  1. Model the effect of the opioid epidemic on transmission of HIV and HCV.
  2. Model the epidemiological and population impacts of individual strategies to prevent and mitigate the harms of opioids and drug injection on HIV and HCV outcomes by evaluating prevention strategies;
  3. Model the epidemiologic and population impact of portfoliosof strategies to mitigate the harms of opioid use and drug injection on HIV and HCV outcomes;
  4. And model the impact of barriers to implementation of effective strategies to reduce the harms of opioid use on HIV and HCV.

“We will perform novel analyses assessing intervention impacts singly and in combination assessing outcomes for HIV, HCV and opioid use disorder,” the researchers wrote in their grant proposal.

Then, the researcher will model new methods for building complex multi-intervention and multi-disease models and developing adaptive testing algorithms for identifying outbreaks.

Finally, the team intends to assess the barriers and intervention approaches “that more realistically reflect implementation issues than current models and hence identify resource needs for system planning.”

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Researchers at Stanford University released findings of a study examining what happens to physicians who experience multiple malpractice claims. Where do physicians with poor malpractice liability records go? Where do they practice? Who would hire them? Stanford professors David Studdert and Michelle Mello, both core faculty members at Stanford Health Policy, wanted to know.

The answers to these questions are described in a new study released March 27 in the New England Journal of Medicine. After reviewing more than a decade’s worth of data from nearly half a million physicians, Studdert and Mello found that physicians who were sued repeatedly were no more likely to relocate their clinical practices than colleagues who had no claims. However, they were more likely to either cease practice or, if they continued to practice, to shift to smaller practice groups or solo practice.

“There is an emerging awareness that a small group of ‘frequent flyers’ accounts for an impressively large share of all malpractice lawsuits,” said Studdert, the lead researcher and professor at both Stanford Law School and Stanford University School of Medicine. “This study confirms that, and begins to shed light on the professional trajectories of these physicians.”

In a 2016 study, also published in the New England Journal of Medicine, Studdert and Mello examined demographic characteristics of claim-prone physicians. “When we presented that work, people kept asking us questions about this group that we couldn’t answer, like who would ever hire or insure them,” Studdert said. “Now we have a better idea.”

A small group with many lawsuits

The research team reviewed data from 480,894 physicians who had 68,956 claims paid against them between 2003 and 2015. The researchers estimated that 2 percent of practicing physicians had two or more paid malpractice claims. Those physicians account for nearly 40 percent of all paid claims, confirming results from their earlier study.

“Our main goal was to follow these multi-claim practitioners over time as they accumulated claims and see where they went and what kind of changes they made to their practices,” said Mello, professor of law and professor of health research and medicine at Stanford and a co-author of the study. “One surprising result was that they were no more likely to relocate than their colleagues.”

In the late 1980s, widespread concerns that physicians with poor liability records were moving interstate to put their reputations behind them led Congress to establish the National Practitioner Data Bank. When a malpractice claim is paid on behalf of a health practitioner, or the practitioner is subjected to certain forms of disciplinary action, the information must be reported to the Data Bank. Employers, such as hospitals, are then required to check the Data Bank.

“Given the policy history here, it was gratifying to find that physicians prone to malpractice claims were not flight risks,” Mello said, noting that it is clearly harder for physicians with bad records to escape their past than it once was.

They don’t move, but many go solo

The study also found that claim-prone physicians were more likely than their peers to quit practicing. Nonetheless, more than 90 percent of physicians who racked up five or more paid claims continued to practice medicine.

The study also showed that claim-prone physicians were much more likely than their peers to shift into smaller practice settings. For example, physicians with five or more claims were more than twice as likely as physicians with no claims to switch to solo practice.

“Compared to practicing in large group practices or hospitals, physicians in small or solo practices are subject to less oversight from administrators and peers,” Mello said. “Quality problems with solo practitioner may be more difficult to detect and report. From a patient safety standpoint, this is the study’s most troubling finding. Frankly, solo practice is the last place we want practitioners who pose patient safety risks to be working.”

While a single malpractice claim is a weak signal that there’s a quality problem, when there are repeated paid claims over a relatively short period of time, that sends an important signal about patient safety risk, Studdert said.

“We think the study’s main message is that regulators and the companies that provide physicians with liability insurance should be paying closer attention to this signal,” Studdert said. “I wouldn’t want my family members to be treated by a physician who had paid out six malpractice claims in the past few years. Who would?”

Additional authors on the study include Matthew J. Spittal from the Melbourne School of Population and Global Health, University of Melbourne; Yifan Zhang from Stanford’s Center for Health Policy; and Derek S. Wilkinson and Harnam Singh from the Health Resources and Services Administration in the U.S. Department of Health and Human Services.

Learn More in this Stanford Law School Q&A with Studdert and Mello

The study was supported by a grant from SUMIT Insurance, a company that is wholly owned by Stanford Hospital and Clinics and Lucile Packard Children’s Hospital, and a Future Fellowship to Spittal from the Australian Research Council.

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Americans know that choosing a health insurance plan can tough. And once you’re retired and possibly on a limited or fixed income, it can become downright brutal.

Stanford Health Policy’s M. Kate Bundorf and Maria Polyakova and their colleagues set out to develop an online decision-support tool to test whether machine-based expert recommendations would influence choice among Medicare Part D enrollees — and make it easier.

“The use of technology seems like a natural way to address the challenges of choosing among plans,” they write in their study published in Health Affairs.

Medicare beneficiaries have been choosing among Medicare Advantage and Part D prescription drug plans for years, and more recently the Affordable Care Act established health insurance marketplaces for those who are younger than 65.

All that choice is supposed to create incentives for plans to offer a variety of low-cost, high-quality products that allow people to choose the plan that best meets their needs.

But sometimes too many good choices can lead to bad outcomes.

“Health insurance is a complex financial product with complicated cost-sharing rules, and the implications of different benefit designs for out-of-pocket spending and health care use vary across consumers depending on their needs,” wrote Bundorf, chief of the Department of Health Research and Policy and an associate professor of medicine at Stanford Medicine.

Another researcher in the study was Albert Chan, chief of digital patient experience and an investigator at Sutter Health, in Palo Alto, as well as an adjunct professor at the Stanford Center for Biomedical Informatics ResearchMing Tai-Seale, a professor of family medicine and public health at University of California San Diego, was also a principal investigator of the study.

Choosing Health Plan is Complicated

“Consistent with these challenges, researchers have documented that many consumers, both young and old, do not understand the characteristics of their plans,” they wrote in the March issue of Health Affairs, which is holding a public briefing on patients-as-consumers at the National Press Club on March 5th. Bundorf will present their research at the briefing in Washington, D.C., which will be streamed live and will be posted here once it has aired.

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Kate Bundorf

“(Patients) often make decisions that may signal inaccurate evaluation of the costs and benefits of coverage — such as staying in their plan when better options are available, not enrolling in the plan that provides the best coverage for their drugs, or enrolling in plans that are objectively inferior to other available choices,” the authors wrote.

The Centers for Medicare and Medicaid Services (CMS) offers a tool to help beneficiaries choose among plans, but older adults — even those with high levels of formal education — find it difficult to use.

So, the research team developed a decision-support software tool called CHOICE to assist Medicare beneficiaries in choosing a Part D prescription plan. The software automatically imported the user’s list of current drugs from their electronic medical records (allowing users to adjust the list if desired); the algorithm would then crunch the numbers to come up with three recommended plans which were likely to be the least expensive for the user.

The team then conducted a randomized trial of this software tool among 1,185 patients of the Palo Alto Medical Foundation (PAMF), a large health-care provider in Northern California. Fifty-four percent of those patients were women, 65 percent were white, and 54 percent were married. Living in the Bay Area, their income and education levels were fairly high: They lived in areas in which the median income is $106,808 and 54 percent of the population has a college degree or more education.

While not representative of the general population of seniors in the United States, the researchers emphasized that it was important to conduct this study among these potential users, who are more likely to respond positively to an interaction with a computer. If these users didn’t find this software helpful or user friendly, it would not likely be a useful tool to roll out across the country as a whole.

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The study participants received access to one of two versions of the CHOICE tool: expert recommendations or individual analysis. Both versions automatically imported information on patients’ prescription drugs from their electronic health records and combined it with information on plan benefit design to provide individually customized information on users’ likely spending on both premiums and prescription drugs in each of the stand-alone Part D plans available in their area. The version of CHOICE that offered expert recommendations combined this information with an explicit recommendation on which plans were best for the user.

Willing and Able

The researchers found that providing an online tool not only increased older adults’ satisfaction with the process of choosing a prescription drug plan, but they also spent more time choosing that plan.

“The most significant finding of our trial is that individually customized information alone didn’t seem to be enough,” Bundorf, who is also a senior fellow at the Stanford Institute for Economic Policy Research (SIEPR), said in an interview. “The tool we developed was most effective when individually customized information paired with a clear-cut algorithmic expert recommendation that highlighted three plans that the computer thought were the best for the user based on total spending for prescription drugs.”

She said she was surprised to see that people spent more time choosing a plan and were more satisfied with the process when they had access to the CHOICE tool.

“Prior to our trial, I thought people might spend less time choosing a plan when they had access to expert recommendations because it would make the process easier,” Bundorf said. “But taken together, these results suggest that people are more engaged in decision-making when they have access to a patient-centered tool.”

Polyakova, who is also a faculty fellow at SIEPR, said a key takeaway from the trial is that people who are likely to use sophisticated tools are already more likely be more sophisticated shoppers of health care and prescription plans.

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Beth Duff-Brown
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The national opioid epidemic has grown at such breakneck speed that public health experts have been left scrambling to keep up. Though they understand the reasons behind the abuse — the solutions are complicated and costly.

Yet there appears to be some success at reducing at least one area of opioid abuse.

In new research by Health Research and Policy’s Eric Sun, the risk for chronic opioid use among patients with musculoskeletal pain actually decreased slightly between 2008 and 2014. 

The Stanford Medicine assistant professor of anesthesiology and pain medicine found that measures such as avoiding opioid use soon after diagnosis can further reduce the risk of addiction, especially among patients at highest risk for chronic opioid use.

"We found that early opioid use after diagnosis is predictive of opioid use longer term, suggesting that it may be prudent to minimize opioid use where possible for patients with musculoskeletal pain,” said Sun, whose research was published earlier this week in the Annals of Internal Medicine.

His co-authors are Jasmin Moshfegh, who is working on her PhD in health policy, and Steven Z. George, director of musculoskeletal research at Duke University School of Medicine.

Patients with lower back or chronic neck, shoulder and knee pain are at the highest risk for opioid abuse since pain meds are typically prescribed to help ease their spasms. 

Patients who suffer musculoskeletal pain may unwittingly transition to chronic opioid use, which means filling 10 or more prescriptions or having a supply for at least 120 days. The prescription drugs include hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and/or oxycodone. Those don’t include heroin and synthetic opioids such as fentanyl.

Sun and his fellow researchers at the Stanford University School of Medicine used a large health-care database to assess the risk and risk factors for chronic opioid use among more than 400,000 “opioid-naïve” patients — those who have never been prescribed painkillers before — recently diagnosed with pain in the knee, neck, lower back or shoulder. 

The sample was restricted to privately insured patients, thereby excluding other policy-relevant populations, such as those who were prescribed pain medications under Medicare or Medicaid.

They found that risk for chronic opioid use ranged from 0.3 percent for knee pain to 1.5 percent for multiple-site pan and decreased for some anatomical regions during the timeframe studied. They discovered a relative decline of 25 to 50 percent across all pain types from 2008 to 2014.

Opioid Abuse

Opioid abuse has its roots in the late 1990s when pharmaceutical companies assured the medical community that patients would not become addicted to pain relievers. Clinicians began prescribing them at greater rates because they worked so well and seemed safe.

Today, more than 130 people die every day from opioid-related drug overdoses from prescription pain relievers, heroin and synthetic opioids such as fentanyl, according to the U.S. Department of Health and Human Services, From 2002 to 2017, there was more than a fourfold increase in opioid deaths, with some 49,000 people dying in 2017.

The Centers for Disease Control and Prevention estimates that the total economic burden of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of health care, lost productivity, addiction treatment and criminal justice involvement.

“While our research found that only about 1 percent of patients with musculoskeletal pain progress to chronic opioid use, this is potentially concerning because it’s an extremely common diagnosis,” Sun said. “By pointing out the scope of the issue and identifying factors that place patients at risk, we hope this research will guide further efforts aimed at reducing opioid use among patients with musculoskeletal pain.” 

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The Trump administration has proposed a new rule that would require direct-to-consumer TV advertisements for prescription drugs to disclose the price of their products.

The Centers for Medicare & Medicaid Services (CMS) said the disclosures would help consumers “make informed decisions that minimize not only their out-of-pocket costs, but also expenditures borne by Medicare and Medicaid, both of which are significant problems.”

The idea enjoys broad public support, since medical care and drug costs continue to skyrocket.  A U.S. Senate report earlier this year revealed that the cost of the 20 most commonly prescribed brand-name drugs have risen tenfold in the past five years.

In a June 2018 poll, 76 percent of Americans favored required drug advertisements to include a statement about how much the drugs cost.

But Michelle Mello, a Stanford Law School professor and Stanford Medicine professor of health research and policy, writes in this New England Journal of Medicine perspective that the proposed rule raises substantial public health and legal concerns.

A potential unintended consequence of price disclosure may be to dissuade patients from seeking care, writes Mello and her co-author, Stacie B. Dusetzina of Vanderbilt University School of Medicine, because of the perception that they cannot afford treatment. For example, Trulicity, a widely advertised drug for type 2 diabetes has a list price of $730 a month.

“Patients who could benefit from diabetes treatment may assume that they cannot afford it, when in fact insured patients’ costs for Trulicity may be much lower, and cheaper treatment options available,” they write. Metformin, for instance, costs $4 per month for patients who pay cash.

CMS would demand drug makers use the list prices from the Wholesale Acquisition Cost (WAC) in their television ads, including that costs “may be different” for those who are insured.

“This wording doesn’t communicate that costs to patients are probably much lower than the WAC,” writes Mello, a core faculty member at Stanford Health Policy.

This could have important legal implications as well, as compelled disclosures in advertising impinge on commercial speech protected by the First Amendment. Furthermore, they write, “disagreement about whether the WAC accurately represents a drug’s price could affect how courts assess the rule when constitutional challenges are inevitably filed.”

The researchers say three aspects of the proposed rule undercut the government’s ability to argue that it would improve patient decision-making and reduce drug spending: 

  1. Price information does little to inform consumer decisions if it inaccurately represents actual cost.
  2. Consumers can already obtain information on cash prices online and their own cost from their insurer.
  3. The rule contains no meaningful enforcement mechanism; CMS plans only to list violators on its website, calling into question whether companies will comply.

“We think that a better alternative would be making patient-specific cost information accessible at the point of prescribing, “ the authors write. 

The cost of prescription drugs should become a routine part of clinician-patient discussions, although they acknowledge that this would put more time constraints on medical practices.

“Providing salient cost information at the right time could help reduce drug spending while preserving patient choice, but we believe that direct-to-consumer advertising is the wrong vehicle,” they write.

 

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Research by Stanford Health Policy’s Michelle Mello looks at what happens when a group of hospitals started systematically acknowledging adverse outcomes in care by apologizing and proactively offering compensation where substandard care caused serious harm. 

Hospitals have traditionally “crouched in a deny-and-defend posture when things go wrong in medical care,” said Mello, a professor of law at Stanford Law School and a professor of health research and policy. The new approach, called “a communication-and-resolution program,” or CRP, is being adopted by an increasing number of health-care facilities.

“None of the hospitals experienced worsening liability or trends after CRP implementation, which suggests that transparency, apology, and proactive compensation can be pursued without adverse financial consequences,” Mello and her co-authors write in the study published Monday in Health Affairs. However, despite the growing consensus that CRPs are the right thing to do, concerns over liability risks remain.”

Stanford Health Policy asked Mello some questions about the research:

Could this new approach to resolving patient conflict be a thing of the future?

Hospitals that adopt CRPs believe they will help improve patient safety and are consistent with the ethical obligation to disclose medical errors; they also hope they will reduce liability costs. However, there is a lot of uncertainty about their effects on costs. On the one hand, being honest with patients could avoid the anger that prompts patients to sue, and compensating injured patients early on saves on litigation expenses. On the other hand, in the traditional system, very few patients injured by substandard care ever get compensated. Offering up admissions of error and early compensation could mean a lot more patients receive payment, raising total costs. Uncertainty about this issue continues to be a barrier to widespread adoption of the CRP approach.

What were the key findings in your study?

We evaluated the liability effects of CRP implementation at four Massachusetts hospitals by examining before-and-after trends in malpractice claims, volume, cost, and time to resolution. We then compared those to trends among similar hospitals in the state that did not adopt CRPs. We found that CRP implementation was associated with improved trends in the rate of new claims and legal defense costs at the two big hospitals that implemented these programs — favorable developments that were not seen at comparison hospitals with no communication-and-resolution programs in place. CRP implementation was not associated with significant changes upward or downward in trends of new claims receiving compensation, compensation costs, total liability costs, or average compensation per paid claim, nor was it associated with a significant change in time to resolution.

So then why are the findings important?

The study helps resolve uncertainty about the liability effects of admitting and compensating medical errors, especially since the study design was much stronger than that of previous studies. We found that the CRP approach does not expand liability risk and may, in fact, improve some liability outcomes. Therefore, hospitals can “do the right thing” — be honest about errors, apologize, and compensate patients who are injured by negligence — without adverse financial consequences.

Who began the CRP approach and what is the average payment proactively made to patients who did not receive proper care?

The approach dates to the late 1990s and was first publicized by a Veterans Affairs hospital in Kentucky and then by the University of Michigan Health System, both of which reported very positive outcomes.  Stanford was also an early adopter.

The model calls for patients to be compensated at about what the hospital estimates their claim would be worth in traditional litigation. In our study in Massachusetts, the median payment to patients was $75,000. That’s a lot lower than the median payment in the tort system, but the mix of injuries is different. In traditional litigation, 85 percent of claims involve very serious injuries or deaths, because smaller claims aren’t attractive to plaintiff attorneys. They just go uncompensated. In CRPs, it’s easier for patients with moderate-severity injuries to have access to justice.

 

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