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.

Some 450 million patient visits to primary care clinics occur in the United States each year. And as the shortage of doctors grows larger each year, primary care teams face increasing pressure both during patient encounters and outside the examining room.

The growing time constraints on primary care clinics — conducting patient consults faster, logging results in EMRs sooner, keeping up with regulatory changes — are worrying patients and physicians alike. 

Stanford Health Policy’s Kathryn M. McDonald and colleagues wanted to better understand the organizational influences of time stressors and the impact they are having on patients.

“Patients get interrupted often when doctors and their care teams are rushed,” said McDonald, MM, PhD, executive director of the Center for Health Policy and Center for Primary Care and Outcomes Research. “They worry about whether their concerns and needs will be addressed adequately. Getting the right diagnosis, treatment and support are all important to patients, so any risk of experiencing suboptimal care due to time stressors is worth understanding better.”

In a study published in the American Public Health Association journal, Medical Care, McDonald and her colleagues wrote that despite concern about the impact time pressure has on the delivery of health care, “scant evidence exists about types of time stress, the organizational factors that shape such stressors in routine care settings, and consequences for patients and practitioners alike.” 

So the researchers analyzed cross-sectional survey data collected from January to August 2016 from primary care teams at 16 randomly selected primary care practices associated with two large Accountable Care Organizations (ACOs) and their patients with cardiovascular disease, diabetes, or both. Through April 2016, they gathered data from 353 physicians and staff members of the clinics.

Then from May to August 2016, the researchers surveyed 1,291 patients by mail and telephone follow-up calls to ask about their concerns.

They determined that the responses translated into two types of stressors related to the lack of time: practice-level time pressure and encounter-level time pressure.

“The stressor condition is similar to the weather—determined by both barometric pressure and temperature — in potentially different way,” they posited.

They found that different organizational factors are associated with each form of time pressure. A patient-centered culture, for example, may include specific patient engagement initiatives, and is associated with reductions in encounter-level time pressure. Similarly, health information systems that provide true support for clinical workflow and good teamwork also corresponded with less encounter-level time pressure. A different organizational influence — leaders that are responsive to the clinic teams — was associated with reductions in practice-level time pressure.

The potential consequences for patients are missed opportunities in patient care and inadequate chronic care support — two very important factors behind successful health care.

“The findings underscore the importance of linking all levels and aspects of physician practice organizations to mitigate  the negative effects of time pressure on patient care” said Stephen Shortell, principal investigator of the Patient Centered Outcomes Research Institute (PCORI) grant that funded the study.  Their other co-author is Hector Rodriguez at the UC Berkeley School of Public Health.

They discovered that one-third of medical team respondents indicated they work in a chaotic practice atmosphere, juggling patient calls, documentation, quality reporting, and many other tasks. The more senior the staff member was, reports of working in a chaotic environment lessened.

Only 31 percent of those respondents said that during patient visits, it was very unlikely for the team to miss all seven specific opportunities related to screening, diagnosis or treatments. 

“Doctors’ offices may increase their chances of preventing adverse effects of time stressors by becoming more patient-centered, coordinating care among team members better and assuring that information technologies make work easier,” McDonald said in an interview about how the results might lead to some solutions. 

“I was struck by the importance of leadership’s responsiveness to their frontline team’s input about changes needed when doctor’s offices are more chaotic,” she said. “Likewise, for clinics that are part of larger groups, like Accountable Care Organizations, the corporate office’s decisions seem to play a role in the perception of time stressors at the practice level.”

The United States is in the grip of an opioid epidemic, which is affecting millions of Americans and claiming thousands of lives. Many trace their opioid dependence back to their doctor’s office, the drugs prescribed for pain after an injury, surgery, or dental procedure. Were these painkillers over prescribed? Did drug manufacturers exaggerate opioids’ effectiveness while deliberately underplaying their danger? Did drug distributors and retailers take necessary steps to ensure that pills weren’t falling in to the wrong hands?  

In this Q&A, Stanford Law Professors Michelle Mello, an expert in health law and core faculty member at Stanford Health Policy, and Nora Freeman Engstrom, an expert in tort law and complex litigation, explain the scope of the opioid problem and discuss the latest cases and legal challenges.

Just how big of a problem is the opioid crisis in the United States? Can you describe the problem’s scope and seriousness? 

Engstrom: The opioid problem is monstrous. Some 2.4 million Americans have an opioid use disorder, and the epidemic has already claimed 300,000 American lives, including 42,000 in 2016 alone. Worse, if the problem isn’t addressed, death tolls will rise: opioids are on track to claim the lives of another half-million Americans within the next decade. That’s like wiping out the entire city of Atlanta. The economic cost is also astronomical. The Council of Economic Advisors has estimated that, in 2015, “the economic cost of the opioid crisis was $504.0 billion, or 2.8 percent of GDP.”

Mello: If there’s one picture that brings home the shocking toll, it’s this one, showing trends in U.S. deaths based on data from the Centers for Disease Control and Prevention.  Nearly all of the “Poisoning” deaths shown here are opioid related. In terms of what’s killing Americans, opioids dwarf car crashes and guns.

Opioid lawsuits are now making news . Some of the actions are criminal, pursued by the states and federal government. Others of those suits are being initiated by cities, counties, and even states. What do those latter suits allege and what damages are the public plaintiffs trying to recover?

Engstrom: In the past four years, roughly 400 cities, counties, and states have initiated lawsuits seeking recovery for their additional public spending traceable to the opioid epidemic. The governmental entities claim they have been injured because defendants—typically, opioid manufacturers, distributors, and big retail pharmacies—have pumped opioids into the hands of their citizens and, in so doing, increased their spending for governmental services. Everything from policing, education, foster care, the provision of health care, even the operation of coroner’s officers, have all been made more expensive because, as compared to a healthy citizenry, an opioid-addicted populace is far less productive and needs much more by way of government help. Facing these spiraling costs, the governmental plaintiffs contend that the opioid defendants—who, they contend, caused and profited from this crisis—should foot the bill.

So, the typical defendants in these cases are opioid manufacturers, distributors, and big retail pharmacies. What is it that the plaintiffs are alleging these defendants did wrong?

Mello: There are some variations state to state, but for manufacturers, plaintiffs are typically claiming that they made false statements to prescribers and others that the drugs were safer and less addictive than alternatives, even when mounting evidence showed otherwise; that they failed to warn physicians and patients about the risks; and that the products were defectively designed—for example, because manufacturers didn’t make the pills tamper-resistant. For distributors and retailers, the claims are that these defendants failed to monitor, detect, investigate, and report suspicious orders of prescription drugs, even though reasonably prudent suppliers would have done so and the federal Controlled Substances Act requires suppliers to maintain effective controls against diversion of controlled substances to illicit markets.

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There is a wealth of data that could help hospitals cut costs while still providing high-quality service for patients, if physicians were willing to join forces with administrators to truly understand how much their services cost, according to a new article by Stanford researchers.

The Centers for Medicare and Medicaid Services (CMS) has been pushing physicians and providers toward population-based payment, which requires that providers reduce their internal costs below payment levels.

In this effort, the beleaguered health-care payer for the elderly has been undertaking innovative payment models, such as accountable care organizations (ACOs) and bundled payment that require providers to better coordinate care and reduce reimbursements and unnecessary or redundant patient procedures.

“However, it has proven challenging for the models, which focus on costs from the payer perspective, to achieve the desired effect of reduced Medicare spending,” writes Merle Ederhof, PhD, in this Health Affairs Blog. The researcher who focuses on issues at the intersection of health-care and accounting is with Stanford’s Clinical Excellence Research Center.

Her co-authors, Alexander L. Chin, MD, MBA and Jeffrey K. Jopling, MD, MSHS, are also at the center, which is dedicated to discovering, testing and evaluating cost-saving innovations in clinical care.

Changing old patterns at hospitals and among physicians

“Highly detailed cost data generated by internal cost accounting systems already exist in a large, and growing, number of health-care organizations,” says Ederhof. 

As Ederhof wrote in this New England Journal of paper last year, the data collected by the Healthcare Information and Management Systems Society shows that more than 1,300 U.S. hospitals have adopted sophisticated internal cost accounting systems.

The authors argue that the cost data produced by these accounting systems can be used in hospitals internally to lower their costs of providing services to all their patients, both within and outside the Medicare system. But physicians must get on board.

“The high adoption rate of these cost-measurement systems is not surprising, considering that the systems are designed around the existing data infrastructure that providers must have in place for billing purposes,” the authors write. “However, while provider administrators have used such cost accounting systems for some time, we are only now beginning to see them being used by interdisciplinary teams involving physicians to restructure clinical processes.”

Some large health-care systems have already started using these accounting systems alongside teams of physicians.

Partners HealthCare in Boston has started to use this approach to analyze costs for a set of services, for example, in a recent project a team of spine surgeons reviewed and discussed unblinded comparisons at the episode and cost-category levels. 

“Analysis of the costs in the individual categories revealed variation in clinical processes across surgeons, which was very illuminating to the team,” the authors wrote.

Leaders at NYU Langone Health have also started to use the cost data in the organization’s “Value-Based Management” initiative. A key feature of the initiative, the authors write, is a dashboard that is accessible to all physicians. For each specific diagnosis-related group (DRG), the dashboard shows cost averages for each physician performing the procedure, at the procedure level and at the level of individual cost categories, such as the ICU, laboratory, operating room and therapies.

“Physicians have been highly engaged and interested in the dashboard since it allows them to compare their costs to their peers and external benchmarks, and to learn how they can restructure clinical processes to lower their costs,” the authors write.

This Value Based Management initiative at NYU, which incorporates cost savings targets, development-level incentives and quality components, has apparently resulted in substantial cost savings for the organization.

Stanford Health Care has also joined the movement to promote value-based care, recently launching its Cost Savings Reinvestment Program. 

Compare, for example, the average cost for a hip replacement surgery among five surgeons who perform the surgery in the same hospital. Then take the “positive outlier,” or the surgeon with the lowest cost for the surgery.

“Once positive outliers are identified, detailed analysis that combines physicians’ clinical expertise and administrators’ insight can uncover ways in which clinical processes can be restructured to deliver high-quality care at lower total episode cost,” the authors wrote.

Then the interdisciplinary team of physicians and administrators must try to understand why that surgeon’s costs are lower and what he or she does differently. Did she order physical therapy sooner after the hip-replacement surgery? Did he use a different anesthesia approach that resulted in a shorter recovery for the patient? 

But you still have to get those four, more expensive surgeons to adopt the less-expensive treatments. And that can go to the heart of a physician’s identity.

“Even just a few years ago concern for the cost of providing health-care services still heavily clashed with physicians’ professional identity,” Ederhof said in an interview. 

The authors believe there is no turning back.

“In my view, the shift in recent years is attributable to the fact that physicians are starting to realize that the rising costs of the U.S. health-care system are no longer sustainable and that things will have to change — with or without their collaboration,” Ederhof 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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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.

*****

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.

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.