In this JAMA commentary, Stanford Health Policy's Victor Fuchs asks whether a single-payer system is an answer to the embattled U.S. health-care industry.

Fuchs, the Henry J. Kaiser, Jr., Professor of Economics and of Health Research and Policy, Emeritus, is also a senior fellow at the Freeman Spogli Institute for International Studies.

Considered one of the greatest thinkers on U.S. health-care policy and reform, Fuchs discusses three key problems for health care for Americans: the uninsured, poor health outcomes (relative to other high-income countries) and high cost. In discussing costs, he said, it will be critical to consider the form that a single-payer health-care system might take. 

"The recent challenges to the Affordable Care Act (ACA), which has increased the number of individuals with health insurance in the United States but has had little effect on cost, has revived the debate about a single-payer health care system. Whether a single-payer system is the answer or not depends on what question is being asked and what form single payer will take. Single payer can take many forms, and many questions can be asked. This Viewpoint considers 3 problems of US health care: the uninsured, poor health outcomes (relative to other high-income countries), and high cost. In discussing cost, it will be critical to consider the form that a single-payer health care system might take."

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The high cost of prescription drugs in the United States came under scrutiny in a new report from the National Academies of Sciences, Engineering, and Medicine, “Making Medicines Affordable: A National Imperative,” co-authored by Stanford Law Professor Michelle Mello, who is also a professor of health policy and a core faculty member at Stanford Health Policy. Published on November 30, the report aims to increase both affordability and accessibility to crucial—often lifesaving—drugs for Americans, with recommendations such as better government negotiated prices, quicker turnaround for generic drugs, and increased financial transparency for biopharmaceutical companies.

In the discussion that follows, Mello explains some of the key challenges facing Americans in need of prescription drugs and key recommendations in the report.

You note in the report that Americans are paying significantly more for their healthcare but are significantly less healthy when compared to developed countries. Do we also pay more for prescription drugs?

Yes. In fact, many countries use “reference pricing” schemes, through which the price that their national health programs pay for prescription drugs is actually calculated as a percentage of what we pay!  One of the ethical issues that weighed on the Committee as we deliberated was that interventions that tamp down prices in the U.S. could have ripple effects in other, less wealthy countries if drug makers seek to recoup their losses by giving fewer price concessions elsewhere.

What is the most important factor leading to higher prescription drug costs in the U.S.? 

The old adage that “every system is perfectly designed to get the result it gets” really came to mind as we investigated why drugs cost so much.  It’s not just one factor, but a whole ecosystem in which multiple actors and factors are contributing.  At the root of it, though, is that there are distortions in the market for drugs that permit things to happen that wouldn’t occur in a truly competitive market.

Which of the 27 action points recommended in the report stand out to you as a priority—and achievable? 

We view our recommendations as a package that should be implemented together, but there are three that we think are especially promising. First, the federal government should directly negotiate drug prices on behalf of all federal programs (and any state programs that want to join in). To create leverage in these negotiations, federal programs should have the flexibility to exclude certain drugs, such as when less costly drugs provide similar clinical benefit.  Second, to improve transparency about where the money is going and where opportunities exist to recapture some of it, biopharmaceutical companies and insurance plans should make public information about the net prices they receive and pay for drugs, including discounts and rebates. Third, insurance plans—especially Medicare plans— should provide better protection against out-of-pocket drug costs. There should be limits on total out-of-pocket costs, and patients’ deductibles and coinsurance payments should be based on the net price of the drug, not the list price.

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A number of the recommendations seem quite procedural, such as eliminating misapplication of funds and inefficiencies in federal discount programs, ensuring financial incentives are not extended to widely sold drugs, and increasing information sharing about reimbursement incentives. Is part of the high cost we pay due to bureaucracy and inefficiency?  

We identified ways in which federal programs are being misused, to the detriment of consumers. One example is what is known as the “340B program,” which was intended to ensure that hospitals and other facilities that serve low-income populations receive deep discounts on drug prices, but is being used by a broad range of facilities that don’t necessarily pass those savings on to patients. Another example is the orphan drug program, which provides very valuable financial incentives for manufacturers to develop drugs for rare diseases.  Companies have obtained these rewards even when they also sell their drug for other indications for which there is a huge market, and in some cases have gotten the rewards multiple times for the same drug.  These problems aren’t about bureaucracy, they’re about gaming the system.  These programs were good ideas that have been very successful in achieving their goals, but have had unintended effects that need to be addressed.

Biopharmaceutical companies have gotten a bad rap in the press, but you note that the cost of developing drugs is very high, and success rates low, with 9 out of 10 investigational products never making it to market. So there is an acknowledgment of the high stakes, high-cost nature of the sector. The report recommends accelerating market entry and use of generic and biosimilar drugs. How can this be implemented without discouraging development of new drugs?

Ensuring affordability of drugs while not discouraging innovation is the central tension that our committee had to grapple with. It’s not easy.  The recommendations in the report strike a balance between these two important objectives.  With regard to generics, our patent system creates a workable deal with drug innovators: create a useful new product, and we’ll give you a period of market exclusivity; generics can’t enter until after that period is up. One problem that our report addresses, though, is that companies have developed ways to extend that period of exclusivity. One is to pay generic companies to delay market entry. Another is to seek follow-on patents on incremental changes to their drug. For example, one company got a new patent by demonstrating their drug could be administered by crushing it up and mixing it with applesauce. The use of this tactic, called “evergreening”, should be curbed.

One recommendation in the report is that the federal government consolidate and apply its purchasing power to directly negotiate prices with the producers and suppliers of medicine, and strengthen formulary design and management. Do government-sponsored medical plans, such as Medicaid and Medicare, already do this? 

By law, the federal agency that runs these programs isn’t allowed to negotiate directly for drug prices for Medicare patients. Instead, all the individual, private plans that provide drug coverage under Medicare Part D do the negotiating. They get discounts, but we think the discounts would be deeper if the bargaining was consolidated in one mighty purchaser.

You noted that private investment is increasingly important to drug development. How much of drug development is supported by public funding, via grants to universities, etc., that then go on to become small startups with private investment? If it is significant, does the public get a good deal on its seed investments?

American taxpayers foot the lion’s share of the bill for the basic-science research that generates information about which molecules are promising to pursue. Private companies pay most of the development costs—that is, testing the molecule in clinical trials to see if it’s safe and effective. The public has gotten a great return on investment in the sense that the industry, particularly in the last decade or so, has been turning out a lot of very innovative, useful products. The work that remains to be done is ensuring that those products are financially accessible to everyone who needs them.

One recommendation is that biopharmaceutical companies and insurance plans disclose net prices received and paid, including all discounts and rebates, at a National Drug Code level. Would this cover all international transactions too, so that we could see costs/prices in other countries? 

No, our recommendation relates to the drug supply chain in the U.S., which is highly complex and highly opaque.

Can you talk about this a bit—why this transparency is important?

One of the things that was frustrating about studying drug affordability is that the various players in our system—such as drug manufacturers, health insurance plans, and intermediary organizations called pharmacy benefit managers, or PBMs—all point fingers at one another when you ask them who is responsible for consumers’ high drug costs.  Yet, there’s very little information available by which to assess their claims. Is the problem that drug makers launch their products at excessive list prices? Or that PBMs buy them at a discounted price, which is kept confidential, and don’t pass those savings along to health plans? Or that health plans get drugs at a deep discount but make subscribers pay cost-sharing (for example, the 20% coinsurance you pay at the pharmacy) as though the drug’s cost was the list price?  Nobody will cough up the data necessary to make these judgments.  Our recommendation addresses that problem.

Are there any next steps for you and the authors of this report? Will there be subsequent research by the group—or coordination with policy makers?

We are working hard to make sure policy makers, journalists, and key stakeholders understand our recommendations and the evidence behind them.  This week, for example, our report was presented to a packed room of Senate staffers.  We have also identified some areas where additional research is needed, and hope that research sponsors will respond to that need.  There is a lot of work to be done.

Sometimes a straightforward explanation and an apology for what went wrong in the hospital goes a long way toward preventing medical malpractice litigation and improving patient safety.

That’s what Michelle Mello, JD, PhD, and her colleagues found in a study published Oct. 2 in Health Affairs.

Mello, a professor of health research and policy and of law at Stanford University, is the lead author of the study. The senior author is Kenneth Sands, former senior vice president at Beth Israel Deaconess Medical Center.

Medical injuries are a leading cause of death in the United States. The lawsuits they spawn are also a major concern for physicians and health-care facilities. So hospital risk managers and liability insurers are experimenting with new approaches to resolving these disputes that channel them away from litigation.

The focus is on meeting patients’ needs without requiring them to sue. Hospitals disclose accidents to patients, investigate and explain why they occurred, apologize and, in cases in which the harm was due to a medical error, offer compensation and reassurance that steps will be taken to keep it from happening again.

Positive results

The study reports on the outcome of a so-called communication-and-resolution program at two large Massachusetts hospital systems. Mello and her co-authors found that the program not only yielded positive results in terms of liability costs but also led to significant patient safety improvements.

“In these programs, hospitals scrutinize every serious harm event to answer the question, ‘What can we learn?’” Mello said. “Traditionally, a risk manager’s focus has been on the patients who complain about the care or threaten to sue. But every patient deserves to know that what happened to them is being taken seriously.”

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Despite concerns that telling patients about errors and proactively offering compensation could cause liability costs to skyrocket, of the 989 adverse events reviewed for the study from 2013 to 2015, only 5 percent led to malpractice claims or lawsuits. And when the program did lead to compensation, the median payment was $75,000. By comparison, the median payment nationwide in 2015 when plaintiffs prevailed in malpractice lawsuits was about $225,000, Mello noted.

“Our findings suggest that communication-and-resolution programs will not lead to higher liability costs when hospitals adhere to their commitment to offer compensation proactively,” the authors wrote.

Pilot program

The authors focused on a program called CARe — Communication, Apology and Resolution — at six Massachusetts hospitals: Beth Israel Deaconess Medical Center and Baystate Medical Center, and two of each center’s community hospitals.

The hospitals demonstrated good adherence to the program protocol, the authors found. Physicians were supportive of the approach but did ask for better communication about the program and what was happening with their patients.

The low percentage of events that led to litigation should reassure hospitals concerned about the risks of being honest with patients, the authors wrote. A likely explanation, according to Mello, is that explaining why adverse events occurred defused patients’ anger. About three-quarters of the time, adverse events were not actually due to error, the study said. Rather, malpractice claims frequently arise when plaintiffs perceive that the health care providers communicated poorly or attempted to cover up negligence, the authors noted.

“Given the rarity with which communication-and-resolution events resulted in settlements, it is reasonable to wonder whether the programs are worth the time they require,” the authors wrote, “but risk managers in our study thought they were. By providing explanations and expressions of sympathy for harms not arising from negligence, communication-and-resolution programs may avert lawsuits springing from misunderstanding.”

Objectives and improved safety

The CARe objectives are to improve transparency surrounding events, improve patient safety, reduce lawsuits and support clinicians in disclosing error or injury.

Medical events were bumped to a CARe evaluation if they met a severity threshold of either causing permanent or temporary harm that led to an extended hospitalization, required an invasive procedure or led to at least three outpatient visits.

Of the 989 total events studied by the authors, 60 of them entered the CARe program because the hospital received notice that the patient intended to sue. Another 929 entered the program when an adverse event was reported that allegedly exceeded the severity threshold, or that met other criteria.

The protocol called for compensation to be proactively offered whenever a violation of the standard of care caused serious harm. Only 9 percent of cases met these criteria. The largest payment made was $2 million. In 181 events, in which compensation criteria weren’t met, hospitals offered to waive medical bills or made other modest gestures, like giving the patients meal vouchers and gift cards. About three-quarters of injuries didn’t qualify for compensation because the standard of care was judged to have been met — a proportion that is consistent with prior studies of medical injuries. About a third of the injuries weren’t caused by the medical care: For example, a patient contracted an infection in the hospital but died from other causes.

“These programs are usually talked about as a way to resolve cases of medical error, but what they do more often is encourage communication with patients about non-error events — as well as systematic evaluation of each event for patient-safety lessons,” Mello said.

The authors also noted that communication-and-resolution programs “can help hospitals foster a culture of transparency by supporting clinicians in making disclosures.”

The safety interventions identified in the CARe investigations included new labeling for high-risk medications, color-coded socks for patients at risk for falls, radio frequency identification tags for surgical sponges, improved interpreter services, improvements for managing the selection of implantables after surgery, and a multidisciplinary checklist for breech deliveries.

Other authors of the study are affiliated with Harvard, Tufts, Baystate Medical Center, and Beth Israel Deaconess Medical Center.

Rural areas of China have made remarkable progress in reducing adult mortality within the past 15 years yet broadened health insurance was not a casual factor in that decline, according to a new study by an international research team that includes Asia Health Policy Program Director Karen Eggleston.

The New Cooperative Medical Scheme (NCMS), a government-subsidized insurance program that began in 2002-03, expanded to cover all of rural China within a decade. Examining NCMS and cause-specific mortality data for a sample of 72 counties between 2004 and 2012, the researchers found that there were no significant effects of health insurance expansion on increased life expectancy.

The study, published in the September issue of Health Affairs, showed results consistent with previous studies that also did not find a correlation between insurance and survival, although much research confirms NCMS increased access to healthcare, including preventive services, and shielded families from high health expenditures.

Commenting on the study, Eggleston said population health policies remain central to China’s efforts to increase life expectancy and to bridge the gap between rural and urban areas.

Eggleston also noted that multiple factors beyond the availability of health care determine how long people live, and anticipates the research team will continue to explore the impacts of NCMS by extending the study to look at infants and youth.

Read the study (may require subscription) and view a related article on the Stanford Scope blog.

Stanford Health Policy’s newest faculty member, Joshua Salomon, believes that one urgent need in global health research is to improve forecasts of the patterns and trends that are the major causes of death and disease.

Salomon, who is leaving leaving his position as professor of global health at the Harvard T.H. Chan School of Public Health to join Stanford on Aug. 1, works on modeling of infectious and chronic diseases and their associated intervention strategies, as well as methods for economic evaluation of public health programs and ways to measure the global burden of disease.

And he looks at the potential impact and cost effectiveness of new health technologies.

“Projections of future trends in health are crucial to formulating policy,” said Salomon, who has a PhD from Harvard. “To think strategically about the technologies and policies that would make the biggest impact on health over the next 20 to 50 years, we really need to start by understanding the range of likely trends in major health challenges over the coming decades.”

Stanford, he said, offers him a “rich collaborative environment” to better learn from advances in forecasting across a range of other disciplines, such as economics, political science, and environmental science.

“With a better picture of what the world is likely to look like over the next 50 years — and what are going to be the most pressing health problems — we can invest wisely and put ourselves in a position to respond more effectively.”

Salomon is also the director of the Prevention Policy Modeling Lab, which is funded by a five-year award from the Centers for Disease Control and Prevention. The consortium represents the collaborative research of experts from Massachusetts General Hospital, Boston Medical Center, Dana Farber Cancer Institute, Yale School of Public Health, Brown University School of Public Health, and the Massachusetts Department of Public Health and.

He will continue directing the lab from Stanford and intends to bring in new research threads from his colleagues here on the Farm. The lab works on a wide range of projects dealing with policy analysis for hepatitis, sexually transmitted infections and diseases such as HIV, and tuberculosis.

“It’s a rewarding grant for me to work on because, unlike a lot of modeling projects, the work that we do really starts from urgent public health questions that policymakers have,” he said. “All of the questions that we are working on are questions that originated directly from discussions with CDC and other public health partners.”

With Salomon’s move to Stanford, the university gains a dynamic duo.

Grace Lee joins Stanford as the Associate Chief Medical Officer at Lucile Packard Children's Hospital in the fall, 2017.

His wife, Grace Lee, MD, MPH, joins in the fall as the Associate Chief Medical Officer at Lucile Packard Children’s Hospital. As a professor of population medicine at Harvard Pilgrim Health Care Institute & Harvard Medical School, Lee has led research in vaccine safety in the FDA-funded Post-licensure Rapid Immunization Safety Monitoring (PRISM) program and the CDC-funded Vaccine Safety Datalink, which monitors the safety of vaccines and studies rare and adverse reactions from immunizations.

She has also examined the impact of financial penalties on rates of healthcare-associated infections, as the principal investigator of an AHRQ-funded study, as well as developed novel surveillance definitions for ventilator-related events in neonates and children.

While at Stanford, Lee said, she intends “to find opportunities to enhance the learning health system approach to improve patient outcomes and population health.”

Salomon has spent his entire career as a collaborator on the Global Burden of Disease project, the world’s most comprehensive epidemiological study commissioned by the World Bank in 1990, which tracks mortality and morbidity from major diseases, injuries and risks factors.

“The study has made a major contribution to global public health because before this study we just didn’t have a comprehensive, systematic understanding of the things that cause death and disability in low- and middle-income countries. But now we do,” he said. “It’s hugely ambitious and very sweeping in scope — and a lot of my work is around providing the evidence we need to inform policy.”

Much of Salomon’s work is global in nature. He’s most recently focused on older adults in one rural South African community, which has a high prevalence of HIV and one of the world’s highest levels of hypertension. His research there aims to inform urgent prevention initiatives tailored to older adults where HIV and cardiovascular risks are moderate or high, as in similar communities in sub-Saharan Africa.

“People don’t expect a high level of ongoing HIV transmission in older adults,” he said. “The double burden that we find, with a very high level of HIV, as well as the high prevalence of diabetes and heart disease, creates enormous strains on the health-care system.”

Tens of thousands of Americans die from drug overdoses every year — around 50,000 in 2015 — and the number has been steadily climbing for at least the last decade and a half, according to the National Institute on Drug Abuse. Yet a team of Stanford neuroscientists and legal scholars argues that the nation’s drug policies are at times exactly the opposite from what science-based policies would look like.

Stanford Health Policy affiliate Keith Humphreys, a professor of psychiatry and behavioral science, and colleagues argue in the journal Science that basing public policy on neuroscience rather than on a desire to punish addicts would improve lives, including those of the victims of drug-related crimes.

“We have an opioid epidemic that looks like it’s going to be deadlier than AIDS, but the criminal justice system handles drug addiction in almost exactly opposite of what neuroscience and other behavioral sciences would suggest,” said Keith Humphreys, a professor of psychiatry and behavioral sciences and one of the leaders of the Stanford Neurosciences Institute’s Neurochoice Big Idea Initiative.

A central problem, the authors argue, is that drug use warps the brain’s decision-making mechanisms, so that what matters most to a person dealing with addiction is the here and now, not the possibility of a trip up the river a few months or years from today.

“We have relied heavily on the length of a prison term as our primary lever for trying to influence drug use and drug-related crime,” said Robert MacCoun, a professor of law and senior fellow at the Freeman Spogli Institute for International Studies. “But such sanction enhancements are psychologically remote and premised on an unrealistic model of rational planning with a long time horizon, which just isn’t consistent with how drug users behave.”

What might work better, Humphreys said, is smaller, more immediate incentives and punishments – perhaps a meal voucher in exchange for passing a drug test, along with daily monitoring.

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About two-thirds of American patients see doctors who receive payments from drug companies, but almost none of them know it.

In a collaborative study between Drexel, Stanford and Harvard, researchers found that 65 percent of participants had visited a doctor within the last year who had received payments or gifts from pharmaceutical or medical device firms.

Payments to physicians can take the form of meals, travel, gifts, speaking fees and research.

Only 5 percent of participants knew that their doctor had received these payments.

“The concern is that physicians with financial ties to drug and device companies may be more likely to recommend those companies' products to their patients, even when other choices would be better for the patient, or just as good but less costly,” said Michelle Mello, the Stanford author and a professor of law and of health research and policy.

Open Payments, which reports pharmaceutical and device industry payments to physicians, was set up as part of the Physician Payment Sunshine Act, a provision of the Affordable Care Act (ACA). The website exists to make industry payment information available to the public.

But the study found that only 12 percent of patients knew this information was accessible. The authors stated that the act’s impact is highly dependent on whether patients know about it.

“Transparency can act as a deterrent for doctors to refrain from behaviors that reflect badly on them and are also not good for their patients,” said Genevieve Pham-Kanter, the lead author and an assistant professor at Drexel’s Dornsife School of Public Health.

Drug and device companies tend to target “key opinion leaders” who are likely to influence the choices of other physicians. During the year studied, the average American physician received $193 in payments. However, the median payment for doctors visited by patients in the study was much higher, $510 for the year.

“We may be lulled into thinking this isn’t a big deal because the average payment amount across all doctors is low,” said Pham-Kanter. “But that obscures the fact that most people are seeing doctors who receive the largest payments.”

Payments vary widely across specialties. Among patients surveyed, 85 percent of those who saw an orthopedic surgeon saw a doctor who had received payments. The next highest was obstetrics and gynecology physicians at 77 percent.

“Drug companies have long known that even small gifts to physicians can be influential, and research validates the notion that they tend to induce feelings of reciprocity,” said Mello.

Despite potential changes to the ACA, Mello believes the Sunshine Act is here to stay. The current version of the American Health Care bill, which would repeal and replace the ACA, does not dismantle it.

This leaves the question of how policymakers can make information about payments to physicians more visible to patients. The authors suggested that the Centers for Medicare and Medicaid Services (CMS) could provide a one-stop shop for patients to view industry payments and other information about their providers online. Mello added that private insurers could make this information available on their “Find a Physician” websites.

“Finding the physician who is right for you depends on a lot of factors,” said Mello. “Whether a physician accepts money from industry may or may not be important to you, but my general view is that the more informed these choices are, the better they will be for patients.”