Prostate cancer is the second leading cause of death among American men, after heart disease.

Yet ever since the prostate-specific antigen (PSA) screening was approved by the FDA in 1986, there has been a debate in the health-care community about the efficacy of the test. The American Urological Association had until 2013 recommended routine testing but did an about-face not long after the U.S. Preventive Services Task Force recommended against regular screening.

The Task Force — and independent, volunteer panel of national experts in prevention and evidence-based medicine — concluded in 2012 that there was “moderate certainty” the benefits of the screening did not outweigh the potential harms. The biggest risks included a false positive that leads to a biopsy that could cause infection, pain and bleeding, as well as surgery and radiation that can provoke impotence or problems with the bladder or bowels.

But the Task Force is now recommending that men aged 55 to 69 talk to their physicians about whether to get the test. New evidence indicates screening in this age group can reduce the risk of metastatic cancer and the chance of dying from prostate cancer.

“Prostate cancer is one of the most common cancers to affect men and the decision whether to be screened is complex,” said Task Force vice chair Alex H. Krist, MD. “Men should discuss the benefits and harms of screening with their doctor, so they can make the best choice for themselves based on their values and individual circumstances.”

Stanford Health Policy’s Douglas K. Owens, director of the Center for Health Policy and the Center for Primary Care Outcomes and Research, said there is also new information on active surveillance — a way of monitoring prostate cancer that may allow some men with low-risk prostate cancers to delay or, in some cases, avoid treatment with radiation or surgery.

Active surveillance, he said, has become a more common choice for men with lower-risk prostate cancer over the past several years and may reduce the chance of overtreatment.

“For men who are more interested in the small potential benefit and willing to accept the potential harms, screening may be the right choice for them,” said Owens, MD, a professor at Stanford Medicine and another vice chair of the Task Force. “Men who place more value on avoiding the potential harms may choose not to be screened.”

The Task Force still recommends men 70 and older do not get the test as a matter of routine.

The panel released its recommendation on the Task Force website on May 8. The final recommendation and evidence reviews were published in the Journal of the American Medical Association (JAMA), along with several editorials.

The guidelines issued by the 16-member Task Force impact virtually every primary care patient and practice in the United States. They make letter grade recommendations and have now bumped the “D” against screening up to a “C,” which recommends screening decisions for prostate cancer be based on professional judgment and patient preference. 

The new recommendation now aligns with those of the American Cancer Society and the American Urological Association. Peter R. Carroll, MD, writes in an accompanying editorial in JAMA that the final recommendation by the Task Force “has restarted a national discussion on prostate cancer early detection.”

“The Task Force deserves credit for this more balanced, fairer approach,” said Carroll, a professor and chair of the Department of Urology at the University of California, San Francisco, who opposed the “D” grade the Task Force had given PSA screens in 2012. “The message now is not ‘no screening,’ but ‘smarter screening,’ preserving benefits and reducing harms.”

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The recommendation also addresses men who are at increased risk, particularly African-American men and patients with a family history of prostate cancer.

“For African-American men or those with a family history of prostate cancer, informing these men of their higher risk for developing prostate cancer should be a part of the conversation,” wrote two researchers from the Cleveland Clinic in another accompanying JAMA editorial.

“The U.S. health care delivery system needs a structure that not only allows, but encourages, a space for physicians and patients to engage in meaningful conversations where shared decision making has the opportunity to take place,” wrote Anita D. Misra-Herbert, MD, and Michael W. Kattan, PhD. “What the updated USPSTF recommendations for prostate cancer screening are asking of physicians is to take time to pause, explain what is currently known, understand patient preferences, and make the screening decision together.”

When a close relative dies, the stress can be overwhelming. But for many adults and children, mourning and grief often give way to healing.

A pair of Stanford scholars now focuses on the impact that loss has on often-overlooked family members: babies. A new publication by Petra Persson and Maya Rossin-Slater indicates that losing a loved one during pregnancy may actually impact the mental health of the child as he or she grows into adulthood.

“We find that prenatal exposure to the death of a maternal relative increases take-up of ADHD medications during childhood and anti-anxiety and depression medications in adulthood,” the researchers wrote in the April edition of the American Economic Review.

Petra Persson

Both are faculty fellows at the Stanford Institute for Economic Policy and Research (SIEPR); Rossin-Slater is an assistant professor of health research and policy with Stanford Medicine and Persson is an assistant professor of economics in the Department of Economics.

“Of course, you cannot prevent family members from dying, and we certainly do not want our findings to constitute yet another source of stress for expecting mothers, who already face rather intense pressure to eat the right foods, avoid activities deemed harmful, and experience an avalanche of health advice,” Persson said. “But our findings potentially point to the importance of generally reducing stress during pregnancy, for example through prenatal paid maternity leave and programs that provide resources and social support to poor, pregnant women.”

Their research focused specifically on singleton children in Sweden born between 1973 and 2011 whose mother lost a close relative during her pregnancy. They used population registers to construct family trees that span four generations, from the children to their maternal great-grandparents. Their sample included all children whose mother lost a close relative — a sibling, parent, maternal grandparent, the child’s father or her own older child — in the nine months after the child’s date of conception or the year after the child’s birth. The study did not account for the quality of those relationships.

Their analysis compared the outcomes of children whose mothers experienced a relative’s death while they were pregnant with those of children whose maternal relatives died in the year after birth. They were thus able to isolate the impacts of fetal exposure to maternal stress from bereavement from all other consequences associated with a family member’s passing, such as changes to family resources or household composition, which affect all children in their sample.

Additionally, by considering the deaths of different relatives, their approach presents a new measure of intensity of stress exposure: the closeness between the mother and the relative who passed in the family tree.

The researchers merged the Swedish data with information about the children’s health throughout childhood and into adulthood, using birth and medical records. They were aided by Sweden’s novel prescription drug registry, which contains all prescription drug purchases and the exact substances and doses prescribed in the country.

“Our research suggests that policies that can reduce stress during pregnancy can have substantial benefits for the next generation,” Rossin-Slater said in an interview. “Moreover, since poor families are more likely to experience stress than more advantaged ones, our results imply that stress-reducing policies that target low-income pregnant women could play a role in mitigating the persistence of socio-economic inequality across generations.”

Persson and Rossin-Slater said they were initially inspired by two recent economic studies using data from Uganda and Iraq, which found that fetal exposure to malnutrition has adverse consequences for adult mental illness.

“Our study offers complementary evidence linking early-life circumstance to adult mental health, but breaks new ground by focusing on stress,” the authors wrote, “which may be more pertinent than malnutrition in modern developed countries such as the United States and Sweden, and by tracing health outcomes throughout the time period between the fetal shock and adulthood.”

Mental illness results in great financial and social costs. In 2008, the market for prescription drugs treating depression totaled $9.6 billion in the United States alone, a sales volume exceeded only by cholesterol and pain medications.

In 2013, one in seven school-age boys were treated with prescription drugs for Attention Deficit Hyperactivity Disorder, fueling a $9 billion market, five times larger than the $1.7 billion market just a decade earlier. The authors note that estimates also suggest that mental illness accounts for more than one-half of the rise in disability costs among men in the last two decades.

Moreover, in Sweden — the setting for their paper – mental illness accounts for a larger share of health expenditures on prescription drugs than any other therapeutic class.

The scholars said that their study contributes to the research in this area by documenting a causal link between fetal stress exposure and mental health later in life. Moreover, by following the same children from birth to adulthood, they were able to observe the onset of adverse effects of exposure to maternal bereavement in utero.

“In sum, our results show that the death of a relative up to three generations apart during pregnancy has far-reaching consequences for mental health during childhood and adulthood,” Persson and Rossin-Slater said.

Their findings suggest large welfare gains of preventing fetal exposure to severe stress: For example, based on the 2008 figure for the U.S. market, the 8 percent decrease in the consumption of prescription drugs treating depression alone can be valued at around $800 million annually.

They conducted a back-of-the-envelope calculation to understand how exposure to economically induced stress during pregnancy might affect the mental well-being of the next generation by relying on past research estimating cortisol responses to grief and to economic shocks like unemployment and poverty.

“Our calculation suggests that in-utero exposure to stress from unemployment may lead to a 17.3 percent increase in the likelihood of ever purchasing a drug to treat ADHD in middle childhood,” they concluded, “and a 9 percent and 5.5 percent increases in the likelihoods of ever purchasing drugs to treat anxiety and depression in adulthood, respectively.”

The newly published findings can inform one way by which policymakers and the medical community can tackle the prevalence and rising costs of mental health issues: by considering ways to make pregnancy — an inherently stressful time — a little easier to manage.

As millions marched against gun violence across the country on Saturday, research by Stanford Health Policy experts about the impact of gun ownership on public health was also in the spotlight.

The Washington Post published an in-depth story about how the work of gun researchers is finally getting attention — an unfortunate consequence of the recent mass shootings in the United States.

David Studdert — a professor of medicine and law — and Yifan Zhang, a biostatics and data analyst with Stanford Health Policy, along with seasoned gun researcher Garen Wintemute of UC Davis’s Violence Prevention Research Program, are trying to answer the question: Are you more or less likely to die if you own a firearm?

“The explosion of national interest in the problem of gun violence since the Parkland shooting has been remarkable,” said Studdert, who is also a core faculty member at Stanford Health Policy.  “And it is inspiring to hear students’ voices — that is definitely a new twist in the politics around this issue. I think there is momentum for change, but I remain pessimistic that we will see the enactment of any substantial reforms at the federal level.”

The Post wrote:

Studdert’s group is using a data set unique to California because of the state’s strict gun laws. Every time a gun is sold in California, a background check logs the purchase and purchaser with California authorities, who also have been unique in their willingness to share such politically fraught data with academic researchers.

Using a sample of 25 million people (taken from California’s voter registration records), Studdert’s team plans to identify handgun owners with the firearm sales records, then compare that against state death records.

The resulting data in theory will help them determine the relationship — whether good or bad — between gun ownership and death.

They call the project LongSHOT, a nod to the project’s scale and ambition.

Academic researchers who were studying the impact of gun violence on public health were dealt a huge financial and political blow in 1996, when the so-called Dickey Amendment was passed by Congress under pressure from gun lobbyists. The law forbids the Centers for Disease Control and Prevention to fund research that might be seen as advocating for gun control. This choked off federal grant money and essential data-gathering on gun violence.

But tucked into the government spending bill in Congress last week was language that indicates the CDC now has the authority to conduct research on the causes and effects of gun violence. Though gun researchers are skeptical that the change in tone will lead to any significant support or funding, some believe that it’s a start. The $1.3 trillion government funding measure also includes efforts to improve state compliance with the national background check system, as well as funding for school counseling and safety programs.

Again, from The Post story:

Yifan Zhang was finishing her PhD in biostatistics at Harvard five years ago when news broke of the Sandy Hook Elementary School shooting.

As a graduate student from China, specializing in highly technical design of clinical drug trials, she had little connection to America’s long-running debate over gun violence. But even now, she said, the anguished faces of those parents she saw on television remain seared in her memory.

So when she heard about a gun-violence research project at Stanford University that could use the statistical skills she had honed on pharmaceuticals, she jumped at the chance.

“I have a son who just turned 1,” said Zhang, 31. “When I think about what I will need to teach him about protecting himself, I think about that school shooting.”

Zhang hopes the Stanford team can one day have an impact.

“I think there are going to be some big decisions that the whole country has to make together, and I’m hoping that our research can help provide evidence and information for the decision making,” she said.

New research finds that even though members of an advisory committee for Medicare are biased toward physician specialties, the partiality often bridges across specialty lines and may improve the quality of its price-setting recommendations.

For the first time, David Chan a core faculty member at Stanford Health Policy and faculty fellow at the Stanford Institute for Economic Policy Research, and his colleague Michael Dickstein from New York University, gained access to more than 4,000 fee proposals that were reviewed over a 21-year span by the committee, which is part of the American Medical Association (AMA). Their independent analysis is in a working paper just released by the National Bureau of Economic Research.

The finding is a surprising insight. Until now, behind-closed-doors deliberations meant nobody has known for sure how the physician-based committee reaches its recommendations for health-care service prices, which Medicare typically adopts. And longstanding criticisms of conflicts of interest have been largely based on anecdotal evidence and the assumption that tasking doctors with setting their own prices must be the equivalent of the fox guarding the henhouse.

But according to the empirical research, even if committee members were entirely neutral, only 1.9 percent of the $70 billion Medicare spends annually on physician care would be redistributed across all services.

“Though the analysis is not a complete vindication of the AMA committee, we find that committee bias has subtle implications for different medical fields and for Medicare,” said Chan, an assistant professor of medicine at Stanford.

“Primary care doctors once thought to be disadvantaged by the presence of specialty physicians on the committee actually benefit from shared interests with other types of physicians,” he says. “And overall, Medicare gets higher-quality information when the committee has connections with specialties.”

Benefits of bias

In their research, Chan and Dickstein, an assistant professor of economics at NYU, set out to uncover whether committee members exhibit bias in their recommendations and, if they do, how much it affects overall prices.

Since 1992, Medicare has tasked the AMA committee, formally known as the Relative Value Scale Update Committee (RUC), with calculating the time and effort component which, together with service costs, accounts for 96 percent of the Medicare reimbursement rate. Most private insurers also establish their payment rates based on Medicare pricing.

The lopsided composition of the committee – specialists significantly outnumber primary care physicians – has also fueled suspicions that prices for complex procedures are rising quickly because doctors on the committee are inclined to increase the cost of the procedures that either fall under or are closely related to their practice areas.

After reviewing internal deliberations on 4,423 fee proposals from 1992 to 2013, the researchers found an increased likelihood that committee members will recommend higher prices for specialties they are connected with. For example, a spinal surgeon on the committee is likely to agree with a price increase for a hand surgery procedure because both share revenue from orthopedic procedures.

The researchers then measured how closely connected a proposed price change was to the specialties represented on the committee and the effect that affiliation had on the recommended reimbursement. They found that the more connected the overall committee was to specialties representing a procedure, the more likely it was to go along with a suggested rate increase.

So why would Medicare rely on a biased industry group to determine its prices? The evidence, Chan said, suggests an explanation: The lack of impartiality on the committee is offset by the finding that the information members contribute to the price-setting process is of higher quality than input from neutral advisers.

“There is this trade-off between bias and the quality of information,” Chan explained. “An unbiased but very imprecise price may be worse than a biased price that is closer to the truth.”

Positive impact on primary care

Contrary to common perception, the researchers also suggest that primary care doctors are not always harmed by these biases. They found that services performed by primary care doctors and specialists often overlap, which means that Medicare pricing policies affect them in similar ways more often than people think. For example, primary care physicians who are internists and family medicine doctors perform some procedures that cardiologists and radiologists do. So, if the price of an electrocardiogram goes up, primary care doctors stand to gain financially from the procedure as much as cardiologists and cardiothoracic surgeons.

And because primary care specialties already benefit from affiliations with other specialties, doubling the number of internists on the committee and quadrupling the number of family medicine practitioners would increase their specialty revenues by less than 1 percent.

Further, the analysis showed that such shared interests — and the closer connection between committee members and the specialties communicating the costs of a procedure — helped boost the overall quality of information behind committee decisions.

“There are very likely several features in Medicare’s pricing structure that disadvantage primary care,” Chan said. “But our research suggests that the arrangement of the RUC is not one of them.”

At age 94, with an extensive collection of health policy research and publications under his belt, Victor Fuchs has a lot to say about the health care system.

The high cost. The uninsured. The fragmentation.

During a speech at the Stanford Institute for Economic Policy Research (SIEPR), the pioneering health economist narrowed his gaze to whether a single-payer system is the fix to those problems.

The answer is complicated, and it depends on the questions behind the question, said Fuchs, a SIEPR Senior Fellow and the Henry J. Kaiser, Jr., Professor of Economics and Health Research and Policy, emeritus. He is also a senior fellow at the Freeman Spogli Institute for International Studies and a core faculty member at Stanford Health Policy.

Recent challenges to the Affordable Care Act have rekindled a debate over the merits of a single-payer health care system — where one entity, namely the federal government, would foot the bill for essential services for all — and Fuchs spoke at SIEPR to succinctly explain what a single-payer system could achieve, what would probably never happen, and why.

The problem, Fuchs pointed out, is that the United States spends the most of any high-income country on health care, yet Americans are not achieving better health outcomes. Part of the solution would have to address the nation’s higher administrative costs, higher prices for prescription drugs, and the expensive increasing mix of services and specialists.

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Fuchs contended a single-payer system would lower costs. For one, it would create the bargaining power needed to offset the monopolistic powers of those providing the drugs, medical services and equipment.

To control costs, “we must move to something like a single-payer plan, but that alone will not be sufficient,” Fuchs said. “It will depend on what kind of single-payer plan it is.”

Even as it provides for universal health care insurance coverage, a single-payer system could take on various forms, including a blend of private and public controls.

And to have any chance at success, Fuchs said, the single-payer system would have to be simple, require minimum bureaucracy, and provide choice.

Then comes the rub, of course: The political will has historically tread against single-payer.

Americans are not willing to provide subsidies for those too poor to afford health insurance; neither do they have a compulsion for everyone to acquire coverage and contribute to those subsidies.

“The country as a whole has not been willing to fully embrace these two principles,” he said. “And I feel you need to have a strong majority of both if you’re going to have universal coverage.”

And unfortunately, Fuchs added, he does not believe universal health coverage would necessarily improve health outcomes. Many other socio-economic and environmental factors also play a role there.

In leading a brief discussion with Fuchs, Mark Cullen, a SIEPR Senior Fellow and professor of medicine, asked what makes him think the federal government would work to control costs under a single-payer system — when it has thus far chosen to exert little buying power under the current structure.

“I have not discussed the political feasibility of this, deliberately,” Fuchs quipped.

You can learn more about Fuchs’ viewpoint in The Journal of the American Medical Association.

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In April 2016 the Equal Employment Opportunity Commission (EEOC) sued Mission Hospital, a large North Carolina health system, after it denied employee requests for religious exemptions from an influenza-vaccination requirement. The lawsuit, which alleges that the hospital violated Title VII of the Civil Rights Act of 1964, is one of a trio of lawsuits in the past two years in which the EEOC has intervened to challenge vaccination mandates for health-care workers. Facing a full-blown trial in February, the hospital agreed to settle the case on January 12, compensating the employees and revising its vaccination mandate policy.

Michelle Mello, PhD, JD, a professor of health research and policy and professor of law, and her colleague James A. Sonne, JD, an associate professor of law and director of Stanford Law School’s Religious Liberty Clinic, write in this week’s New England Journal of Medicine that the EEOC litigation “is cause for unease” among the growing number of hospitals with mandatory influenza-vaccination policies. Their article is co-authored with Douglas J. Opel, MD, MPH, an assistant professor of pediatrics at the University of Washington.

“These policies are an important public-health strategy since vaccination rates for health-care workers continue to fall short of the Healthy People 2020 target of 90 percent,” the authors write. “But they create thorny problems when it comes to exemptions. In particular, when and how must health-care workers’ religious objections be accommodated to conform to the law?”

The paper comes during what could be the worst flu season since the 2009 swine flu pandemic. The Centers for Disease Control and Prevention reports that this influenza season has claimed the lives of 37 children and is on track to rival the 2014-2015 flu season. The CDC estimates that 34 million Americans got the flu that season; more than 700,000 were hospitalized and about 56,000 people died.

So far this season, an influenza A virus called H3N2 has been the most common form of influenza. Preliminary estimates suggest that this season’s influenza vaccine is about 40 percent effective. Yet antibodies made in response to vaccination with a certain set of influenza viruses can sometimes provide protection against different but related viruses.

Stanford Health Policy asked Mello and Sonne questions about their research and findings.

Q: What prompted you to undertake this research and write about the subject?                                   

Mello: More and more hospitals are mandating their employees get vaccinated against influenza. This is good policy: influenza is a serious disease and voluntary programs have had disappointing results. Having a policy that requires health-care workers to be vaccinated helps protect employees themselves but also the patients they take care of, who are often at high risk of serious complications from influenza. We wrote this article to help make hospitals aware of potential legal challenges based on religious discrimination claims and help them ensure their own mandates are well-written and reasonably applied in order to avoid legal challenge and maintain a healthy and productive workplace. 

Q: Did anything surprise you while conducting your research?

Mello: Yes. First, the Equal Employment Opportunity Commission filed the three latest lawsuits on behalf of the employee. That’s unusual; the EEOC typically only injects itself into an individual employee’s dispute when it perceives that the employee’s case presents an issue of public concern.

Second, there have been about 15 cases filed between 2011 and 2016 that have challenged hospital influenza vaccination mandates on religious grounds, and most of them didn’t get thrown out by the judge—they were settled, or are heading toward trial. This indicates a need to understand the claims made by these lawsuits so that hospitals can avoid future legal challenges. When we looked at the plaintiffs’ grievances, we saw some pitfalls that can be easily avoided if hospitals are attentive to what the law requires and what seems to provoke employees to sue. For example, some hospitals were unduly rigid, to the point of seeming arbitrary, in enforcing deadlines or reviewing exemption requests.

Q: Is it common for hospitals to have influenza vaccination requirements for their employees?

Mello: Many hospitals do, and some states require it. Evidence suggests that these requirements are effective at increasing vaccination rates of their employees. However, hospitals’ requirements vary, with some allowing their employees to opt out of getting the influenza vaccine for religious reasons and others only allowing opt-outs if the employee has a medical contraindication to influenza vaccination, such as having experienced a severe allergic reaction to a prior dose of the vaccine or having an allergy to a component of the vaccine.

Q: Why allow religious exemptions to employer vaccination requirements at all?

Sonne: One reason might simply be to defuse perceptions of coercion and enhance the sustainability and acceptability of the requirements. In addition, Title VII of the Civil Rights Act of 1964 requires employers to reasonably accommodate employees’ religious practices unless doing so presents an undue hardship for the employer. Carefully crafted religious exemptions to influenza-vaccination requirements are a strategy that employers might need to use to avert religious-discrimination claims.

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A small proportion of workers may want to serve in the health-care field but nonetheless feel very strongly about not receiving the vaccine as a matter of their religious faith. Depending on the context, accommodating those sincere beliefs doesn’t necessarily impact public health and, arguably, it’s a better use of hospitals’ time and resources to focus on getting the vaccine to the vast majority of unvaccinated workers who don’t object but just haven’t gotten around to being vaccinated. Again, we’re not talking about a large group of people who both work in the industry and have these religious conflicts.

Q: A new civil rights division at the Department of Health and Human Services aims to protect health-care workers who refuse to provide services that violate their religious beliefs. Will there be more support now for health-care workers wanting to opt out from influenza vaccine for religious reasons?

Sonne: This is a good question, but the answer is unclear so far. The “Conscience and Religious Freedom Division” will be part of HHS’s already-established Office of Civil Rights. It will be charged with enforcing laws in the health-care field that forbid religious discrimination or require accommodation of religion—which certainly expresses an enforcement priority in this area of law. That said, the division doesn’t appear to create any additional legal duties but is meant only to enforce existing laws. And its creation also appears to have been motivated more by concerns about having to provide services that some clinicians find morally objectionable, like abortion, which arguably is a different situation. We’ll see.

Q: Are health-care organizations struggling to get their employees vaccinated against influenza?

Mello: HHS’s Healthy People 2020 goal is to have 90 percent or more of health-care personnel vaccinated against influenza. Recent estimates show that only about 78 percent of health-care personnel got vaccinated during the flu 2016-17 season, so we are falling short of that goal. The CDC recommends that all health-care personnel receive an annual influenza vaccination.

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Mello: Studies have shown that some of the primary deterrents to immunization are concerns related to the safety and efficacy of the influenza vaccine, despite the fact that each year the vaccine undergoes a review by FDA to assure its safety and potency before it is approved for immunization of the public.  Health-care workers also may underestimate their risk of getting the flu or the risk they pose to their patients if they get sick—or they may simply be busy enough that they don’t prioritize getting vaccinated.

The fact is that healthy adults can pass the influenza virus to someone else one day before symptoms begin, and they can continue to infect others up to five days after getting sick. Therefore, it is possible for a healthy adult to unknowingly spread the virus to patients at high risk for serious complications from influenza.

Q: What did you find in your analysis of the lawsuits?

Mello: We found some clarity regarding the type of belief that qualifies for a religious exemption under Title VII. One court that dismissed a lawsuit, for example, stated that a religious belief can't simply be a personal moral code or something specific to vaccines. Rather, it must relate to ultimate questions about life, purpose and death. Providing a religious belief definition in hospital policy and explaining what does and doesn’t qualify should help reduced misguided requests and lawsuits.

Sonne: We also found that employers can satisfy their legal obligation to reasonably accommodate workers’ religious beliefs in a variety of ways aside from granting exemptions from vaccination, but should try to find the least onerous option that still protects patients. Tailoring accommodations to the specific individual based on, for example, how much contact they have with patients is good policy.

Finally, we found that, as in so many other litigation contexts, lawsuits in this area are often inspired by a feeling by the affected employees that the processes used to weigh their opt-out requests just weren’t fair. Hospitals can, therefore, avert problems by affording employees a reasonable opportunity to explain their deeply held religious beliefs, avoiding unnecessary or overly rigid administrative procedures and rules, explaining their reasons for denying exemptions and treating religious objectors with respect.

The federal Centers for Medicare & Medicaid Services (CMS) sent a letter to state Medicaid directors on January 11 announcing a policy change that allows states to experiment with how they deliver the public health insurance for low-income residents of their states. The provision that prompted headlines was its suggestion that state officials seek a waiver to Medicaid regulations allowing them to attach work requirements, or what CMS calls “community engagement,” for eligibility among able-bodied adults.

CMS Administrator Seema Verma said the work requirement among eligible adults would “make a positive and lasting difference in the health and wellness of our beneficiaries.”

In a speech to Medicaid officials in November, Verma criticized the Obama administration for focusing on expanding Medicaid enrollment under the Affordable Care Act, rather than helping the poor move out of poverty and into jobs that provide health insurance.

“Believing that community engagement does not support or promote the objectives of Medicaid is a tragic example of the soft bigotry of low expectations consistently espoused by the prior administration,” she said. “Those days are over.”

So far, the states that have applied for the Medicaid waiver that would allow them to impose the work requirement are Arizona, Arkansas, Indiana, Kansas, Kentucky, Maine, New Hampshire, North Carolina, Utah and Wisconsin. The Kentucky waiver application said it would require most nondisabled Medicaid beneficiaries age 19 to 64 to work at least 20 hours a week.

Medicaid was created in 1965 for families on public assistance and low-income seniors. It is now the nation’s largest health-insurance program and covers 70 million people, or about one in five Americans, and includes pregnant women and newborns, the elderly in nursing homes and people with disabilities.

Opponents of the work requirement say it demonizes the poor and that low-income people will fall through the cracks and could be denied coverage because of technicalities or errors in their paperwork.

We asked FSI senior fellow and Stanford Health Policy faculty member Jay Bhattacharya — a professor of medicine and health economist who is an expert on government policies designed to benefit vulnerable populations — a few questions about the new policy.

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Stanford Health Policy: A study by the Kaiser Family Foundation found that among nonelderly adults with Medicaid coverage — the group of enrollees most likely to be in the workforce — nearly 8 in 10 live in a working family and a majority are working themselves. They also found most Medicaid enrollees who work are working full time but their annual incomes are still low enough to qualify for Medicaid. So who are the Medicaid recipients that the Trump administration is targeting — and to what end?

Bhattacharya: The CMS decision permits states to experiment with work requirements for able-bodied Medicaid enrollees. That is, it does not permit state experiments with work requirements for Medicaid enrollees who qualify because of a disability, or qualify because they are pregnant, or otherwise qualify because of physical or medical incapacity to work. At least as a first cut, the CMS decision permits states to impose work requirements for Medicaid enrollees who qualify through the expansion in Medicaid induced by the Affordable Care Act and does not permit work requirements on traditional Medicaid population who qualified in ways permitted before the ACA. States can also require alternatives to work, including volunteering, caregiving, education, job training and even treatment for a substance abuse problem.

The end goal as stated in the CMS letter is to improve the health and well-being of the able-bodied poor. The logic is that (1) for able-bodied individuals, regular work is an important component of overall health, and (2) all income-linked welfare programs (Medicaid included) induce incentives not to work, or to work less. There is a literature in economics that documents this incentive (see this paper by Aaron Yelowitz.) The mid-1990s welfare reform law required this sort of linking of work and welfare, and CMS argues this decision permits states to align Medicaid with other income-linked welfare programs. If the KFF study is right, the decision will have an effect on a minority (perhaps a substantial minority) of able-bodied Medicaid recipients, since the majority are already working.

Stanford Health Policy: Under current law, can states impose a work requirement as a condition of Medicaid eligibility?

Bhattacharya: For a state to impose a work requirement, they must request a waiver from the Social Security Act to conduct a demonstration project. These waivers are permitted under current law, but are provided at the discretion of the appropriate executive agencies, in this case, CMS. A different administration might decide not to permit these waivers, and I think in general the Obama administration was more reluctant to permit this kind of state experimentation. The main substance of the CMS decision is to broadly signal to states that they will now be willing to provide such waivers.

Stanford Health Policy: Do critics of the work-requirement waiver have valid fears that low-income elderly or disabled people will fall through the cracks on technicalities or challenging paperwork?

Bhattacharya: Paperwork mistakes and problems caused by bureaucratic indifference are always possible when it comes to a program like Medicaid, which has such a complicated variety of paths to qualify. It is an empirical question whether such considerations would be more salient were a state to impose work requirements for a subset of Medicaid enrollees on top of the existing requirements.  Every state has experience with similar work requirements for qualification for other welfare programs, such as temporary assistance for needy families (TANF). Given that, it seems unlikely to me that — because of technicalities or paperwork — additional work requirements would be incorrectly applied to many elderly or disabled people applying for Medicaid.

Stanford Health Policy: Some states have proposed tying Medicaid eligibility to work requirements using waiver authority that may be approved by the Trump administration. What could this mean for Medicaid recipients in those states? In Kentucky, which expanded Medicaid, some state officials have said work requirements could lessen the program’s impact on the state budget.

Bhattacharya: I suppose it could have some effect on state budgets by reducing the number of people who qualify for Medicaid. I anticipate only a small effect on state budgets, though, because through the ACA, the Feds pay 100 percent of Medicaid costs for people who qualify via the ACA’s income provision, although that gradually phases down to 90 percent in 2020 and remains at that level.

Stanford Health Policy: How will the states that do not apply for the waiver, such as the large-population states of California and New York, be impacted by this change in Medicaid policy?

Bhattacharya: States that do not apply for a waiver will maintain their existing requirement for Medicaid qualification, including no work requirements for able-bodied Medicaid enrollees who qualify through the ACA’s Medicaid provisions.

At least 91 Americans die every day from an opioid overdose. The epidemic has claimed more than 300,000 lives since 2000 and is expected kill another half million over the next decade.

So perhaps it’s time to step up lawsuits against the drug manufacturers that sell the opioids to the tune of $13 billion per year, Stanford Health Policy’s Michelle Mello argues in a commentary in the current issue of The New England Journal of Medicine.

Mello, a professor of law and of health research and policy, and co-author Rebecca L. Haffajee, an assistant professor of health management and policy at University of Michigan School of Public Health, note that although heroin and illicitly manufactured fentanyl account for an increasing proportion of opioid overdoses, the majority of people who are addicted to opioids get hooked on prescribed painkillers.

While clinicians and health-care providers are trying to prescribe fewer opioids, Mello and Haffajee believe litigation is another crucial method to fight the crisis.

“The search for solutions has spread in many directions, and one tentacle is probing the legal accountability of companies that supply opioids to the prescription market,” the authors write.

The final report of President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis details decades of aggressive marketing of oxycodone from 1997-2002 that led to a tenfold rise in prescriptions to treat moderate to severe pain. “To this day, the opioid pharmaceutical industry influences the nation’s response to the crisis,” the report said, noting the industry had sponsored some 20,000 conferences for physicians on managing pain with opioids while claiming their potential for addiction was low.

Mello and Haffajee argue that similar to the early cigarette promotions by Big Tobacco, opioid manufacturers have failed to adequately warn patients about addition risks on drug packaging and in their marketing campaigns.

“Some recent claims allege that opioid manufacturers deliberately withheld information about their products’ dangers, misrepresenting them as safer than alternatives,” they write.

Early attempts to bring class-action suits against opioid manufacturers have encountered procedural barriers. Judges typically find that proposed class members lack sufficiently common claims because of different circumstances surrounding opioid use and clinical conditions.

But the tide may be turning. There has been an uptick in litigation against Big Pharma since Purdue Pharma, the maker of the blockbuster painkiller, OxyContin, agreed in 2007 to pay $600 million to settle charges that it misled federal regulators, doctors, and patients about the drug’s risk of addiction and its potential to be abused.

“As the population harmed by opioids grows and more information about the population is documented, it becomes easier to identify subgroups with similar factual circumstances and legal claims — for example, newborns with neonatal abstinence syndrome,” they said.

Perhaps most promising, the authors write, is the “advent of suits brought against drug makers and distributors by the federal government and dozens of states, counties, cities, and Native American tribes.

“Because the government itself is claiming injury and seeking restitution so that it can repair social systems debilitated by opioid addiction, these suits avoid defenses that blame opioid consumers or prescribers,” they said. “They also garner substantial publicity.”

The government is borrowing from the playbooks used to sue tobacco and firearms companies, relying on four strategies:

• Focus on the “public scourge” created by the opioid manufacturers due to their oversaturation of the market, arguing that opioids constitutes a public nuisance;
• Paint the opioid companies’ business practices as deceptive;
• Call out the manufacturers’ lax monitoring of suspicious opioid orders; and
• Ask courts to make companies disgorge the “unjust enrichment” they have reaped at the government’s expense through their unfair business practices.

Two large settlements have occurred in state cases that included unjust enrichment claims, the authors note, although the pharmaceutical companies avoided admitting fault. The Commonwealth of Kentucky settled with Purdue Pharma for $24 million in 2015 over allegations that it had profited while Kentucky was left paying associated medical and drug costs of those who became addicted.

Earlier this year, drug wholesaler Cardinal Health Inc. agreed to pay $20 million to settle a lawsuit brought by West Virginia’s attorney general over accusations that it flooded the market with opioids in a state that now has the highest opioid overdose rate in the nation.

Such lawsuits have garnered a lot of media attention and contributed to pressure on the U.S. government to take action against the abusive practices of drug manufacturers and distributors.

“Win or lose, lawsuits that very publicly paint the opioid industry as contributing to the worst drug crisis in American history put wind in the sails of agencies and legislatures seeking stronger oversight,” Mello and Haffajee write. “Together, litigation and its spillover effects hold real hope for arresting the opioid epidemic.”

Listen to a podcast with Haffajee talking about the opioid crisis.