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Health Care Policy
Lights flash, a siren wails and an ambulance races to help a person whose heart has stopped beating.
In most cases, a 911 dispatcher will have sent an advanced life support, or ALS, ambulance to the scene, equipped with sophisticated gear and staffed with a crew of highly trained paramedics who can deliver specialized care in the field, including intubations and IV interventions.
Unfortunately, according to a new study by health policy researchers at Harvard, those advanced techniques actually increase the patient’s risk of death.
People with out-of-hospital cardiac arrest who were treated by an ALS ambulance are more likely to die and to have poor neurological outcomes than those treated by basic life support, or BLS, ambulances, which use less-sophisticated treatment techniques, the study finds. The results are published today in JAMA Internal Medicine.
“Our study suggests BLS saves more lives than ALS, and therefore, the principles of BLS should be a priority for treating and transporting out-of-hospital cardiac arrest patients,” said Prachi Sanghavi, a PhD student in the Evaluative Science and Statistics concentration of the Harvard Program in Health Policy, and lead author of the study.
BLS ambulances provide a more limited set of treatments in the field and instead focus on rapidly transporting patients to the nearest emergency department. For example, instead of waiting to intubate a patient, they might provide air using a simple, hand-pumped ventilation bag.
“We know that community training, rapid and appropriate delivery of pre-hospital care, and high-quality hospital cardiac care may substantially improve these survival rates,” said study author Alan Zaslavsky, professor of health care policy at Harvard Medical School. “This study provides important insight about the choice between providing more care in the field and bringing patients as quickly as possible to hospital treatment.”
Since the 1970s, ALS has grown to become the predominant form of care for cardiac arrest and other medical emergencies in the US, but there is little evidence that ALS saves lives compared with BLS, and some research has suggested that the treatments and additional time associated with ALS may harm patients. In the current study, the researchers found that patients who received BLS instead of ALS were more likely to survive to hospital discharge, to 30 days, and to 90 days.
Of an estimated 380,000 cases of out-of-hospital cardiac arrest annually, 90 percent do not survive to hospital discharge, the researchers said. But at 90 days, BLS patients were nearly 50 percent more likely to survive than ALS patients. Basic life support was also associated with better neurological functioning among hospitalized patients, with fewer incidents of coma, vegetative state or brain death.
The researchers obtained a large, random sample of Medicare claims for patients in nonrural counties for ambulance services that occurred between 2006 and 2011. They compared survival and other outcomes between patients who received ALS and those who received BLS, using statistical methods to balance the two groups for characteristics such as age and other factors that might impact both the type of ambulance dispatched and the chances for survival. For example, older patients might be both more likely to receive ALS and more likely to die from cardiac arrest. The study adjusted for these possible sources of bias by studying comparable populations.
Other co-authors included Anupam Jena, HMS assistant professor of health care policy and assistant professor of medicine at Massachusetts General Hospital, and Joseph Newhouse, John D. MacArthur Professor of Health Policy and Management at Harvard University, director of the Division of Health Policy Research and Education, chair of the Committee on Higher Degrees in Health Policy, and director of the Interfaculty Initiative in Health Policy.
This research was funded by a National Science Foundation Graduate Research Fellowship and a Health Services Research Dissertation Award from the Agency for Healthcare Research and Quality, and by an Early Independence Award from the National Institutes of Health.
Health Reform Progress
Health care reform is a delicate balancing act: How can we cut costs while also improving patient experiences and patient health? That’s the trillion dollar question.
Many key reform models hope to achieve those three goals by changing the way care is paid for by moving away from traditional fee-for-services arrangements, where providers are paid more for each service they deliver. Under these payment reforms, providers are offered a share of whatever savings they generate through more efficient care delivery (providing more high-value services and fewer low-value services).
This week, two Harvard Medical School studies published in the New England Journal of Medicine provide cautious optimism that these efforts may be starting to work.
A study of reforms embedded in the Affordable Care Act found that patient experiences with care improved in the first year of the Accountable Care Organization programs in Medicare, and a study of the private-payer global budget model found cost savings and improved quality of care in the first four years of the commercial Alternative Quality Contract of Blue Cross and Blue Shield of Massachusetts.
“The health care system is transforming as we move to new payment models,” said Michael Chernew, Leonard D. Schaeffer Professor of Health Care Policy at HMS and an author on both papers. “While there’s certainly more to learn, preliminary results suggest that this transformation may improve quality and, at least in some settings, reduce spending.”
The two ACO programs under the ACA, the Pioneer program and the Medicare Shared Savings Program, launched in 2012, expanded rapidly through 2013 and 2014, and now serve about 5.6 million Medicare beneficiaries, representing about 11 percent of the Medicare population.
The NEJM study is the first to measure the early impact of the program on the experiences of patients enrolled in ACOs, which continue to reimburse providers on a fee-for-service basis, but offers providers a share of the savings earned by more efficient use of services.
“As payment moves away from fee-for-service toward incentives to limit health care spending, we found no evidence of deteriorating patient experiences in ACOs. In fact, ACOs achieved meaningful improvements for patients in some key areas,” said lead author of the ACO study J. Michael McWilliams, associate professor of health care policy and medicine at HMS and Brigham and Women’s Hospital. “The improvements that we found in patient experiences constitute important initial progress in fostering high-quality, patient-centered care in Medicare.”
The improvements were concentrated in areas that organizations may more easily modify though the implementation of new scheduling, referral or information systems. For example, beneficiaries served by ACOs reported significant improvements in timely access to care, perceived coordination of their care and access to their medical information.
The greatest improvements occurred among the most medically complex quarter of patients, those with multiple illnesses who are the focus of ACO efforts to improve quality and lower costs. In this group, improvements in overall ratings of care were equivalent to moving an ACO from average performance to being in the top 4 to 18 percent of ACOs.
“While these early findings are encouraging, there is a pressing need for regulatory and legislative changes to strengthen ACO incentives, expand provider participation in new payment models and address potential downsides of provider integration, such as higher prices,” McWilliams said. “Our study suggests a promising start, but there is a long road ahead.”
Savings in commercial care
For the AQC study, the researchers found that the plan, which uses global budgets for health care, has improved the quality of patient care and lowered costs during the four years since it was first implemented. Health care provider organizations were given a budget to care for patients insured under the health care plan, in contrast to the widely used fee-for-service system, where providers are reimbursed for each medical service they deliver.
“These results are encouraging, because, throughout our health care system, spending is growing at an unsustainable rate and our quality of health care is not as high as it should be,” said study author Zirui Song, HMS clinical fellow in medicine and resident at Massachusetts General Hospital. “Global budgets and other payment reform initiatives provide incentives for physicians and hospitals to think collectively about population health and to focus on coordination of care.”
The study compares Blue Cross members who have a primary care physician as part of an AQC contract to a control group of commercially insured individuals across eight northeastern states (Connecticut, Maine, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island and Vermont) who also have designated PCPs in their health plans.
Comparing the financial and quality results of the AQC with this control group was important, the researchers said, because it accounts for more general trends locally and nationally—showing that the AQC achieved savings over and above what was happening in similar health care environments.
Though trends were similar prior to the AQC, from 2009 to 2012 Massachusetts AQC enrollees had smaller increases in medical spending over the first four years of the contract than similar individuals in other states, researchers said. Patients who received care under the AQC also experienced larger improvements in measures of quality of care such as the percentage of diabetes patients who received eye exams or blood sugar monitoring, or measures of how well patients controlled their blood pressure or cholesterol, the researchers said. Although providers generally captured the savings in the early years of the AQC, by the end of 4 years estimates suggest savings for the payer as well, relative to what otherwise would have been spent.
The ACO paper was funded by grants from the National Institute on Aging (P01 AG032952), John and Laura Arnold Foundation, Doris Duke Charitable Foundation (Clinical Scientist Development Award #2010053) and Beeson Career Development Program (National Institute on Aging K08 AG038354 and the American Federation for Aging Research).
The AQC paper was funded by the Commonwealth Fund and the National Institute on Aging (F30-AG039175), the National Bureau of Economic Research Fellowship in Aging and Health Economics (T32-AG000186) and the Charles H. Hood Foundation.
Are Reduced Residency Hours Risky?
Cutting resident physician work hours has not led to lower-quality physicians.
Amid rising concerns about medical errors, residents’ hours were capped at 80 per week in 2003 with shift lengths not to exceed 30 consecutive hours. To assess whether shortened residency training resulted in lower-quality physicians upon completion of residency (as measured by health outcomes of patients treated by newly independent physicians), Anupam Jena, assistant professor of health care policy at Harvard Medical School and colleagues at Stanford School of Medicine studied data from more than 4 million Florida patients between 2000 and 2009.
The findings, published today in the October issue of Health Affairs, show that the reforms did not adversely affect the quality of physicians who trained during that period, as measured by their patients’ hospital length of stay or inpatient mortality.
“This is perhaps the most hotly debated question in medical education,” Jena said, “with many believing that doctors trained with fewer hours are less well-prepared for independent practice after the completion of residency.”
The movement to limit residents’ hours began in New York State in 1989 following a patient death that was attributed, in part, to mistakes made by exhausted medical residents. Proponents of the reform also believed that sleep-deprived residents were not able to learn at full capacity, thus wasting many of the hours they spent in training by working below their full potential.
Opponents of the reform feared that physicians trained with fewer hours of work or shorter shifts would lose important experience by seeing fewer types of conditions and missing out on crucial context from observing patient care over a lengthy admission that might last longer than the maximum allowable shift length under the new restrictions.
Following the reforms, studies were conducted that showed some reduction in medical errors committed by residents and demonstrated improvements in resident quality of life, but no study had been done to assess how the modification in training might have changed the quality of doctors after they had completed their training and had begun their independent practice.
“A major reason why we have no evidence on the long-term effects of duty-hour reductions on the quality of physicians completing residency is that data linking patient outcomes to physician training history has simply been unavailable,” Jena said.
The researchers created a unique data set by linking patient information from hospitals with a physician licensure registry that included details about the timing of each doctor’s education. The study compared patients’ in-hospital mortality rates and average length of stay among three categories of physicians: those who completed their residency before 2003, those who experienced partial exposure to duty-hour reforms (completing residency in 2004 or 2005) and those whose entire residency occurred after the duty-hour reforms of 2003.
One hurdle to studying outcomes of newly independent physicians who completed residency prior to the 2003 reforms is that hospital care has improved substantially in the last 15 years, meaning that one would expect hospital mortality to have improved over the study period even without changes in residency work hours and training. To address this issue, Jena and his colleagues used “senior physicians” —those with more than ten years of post-residency experience—as a control group for comparison to newly independent physicians to account for declines in hospital mortality that would be expected to affect new or experienced physicians alike.
After adjusting for improved hospital care, the study found that hospital mortality among patients whose physicians completed internal medicine residency in 2003 or earlier (zero exposure to reduced work hours) was 3.3 percent compared to 3.2 percent among patients whose physicians completed residency in 2006 or later (three years’ exposure to reduced work hours).
Interestingly, high-risk patients—those with predicted hospital mortality in the top quarter of all hospitalized patients—whose physicians were trained after 2006, actually had better outcomes. Hospital mortality among high-risk patients whose physicians completed residency in 2003 or earlier was 7.7 percent; this is statistically greater than 7.3 percent for high-risk patients whose physician completed residency in 2006 or later. This suggests that reduced work hours may even have improved the quality of training of physicians caring for high-risk hospitalized patients.
Jena acknowledged that hospital mortality is a very crude measure of quality and that the study looked only at internists. Because the patients were anonymous, the researchers couldn’t track readmissions, and richer data would be necessary to measure subtler characteristics like diagnostic skills, procedural outcomes and physician efficiency.
“Mortality, however, is the first and most important measure to evaluate, although there are many other things to consider,” Jena said. “We are just scratching the surface.”
Co-authors of the study included Lena Schoemaker and Jay Bhattacharya, both of Stanford Medical School. Support was provided by the Office of the Director, National Institutes of Health (Grant No. 1DP5OD017897-01) and the National Institute on Aging (Grant No. R21 AG041112-02).
Consequences of Consolidation
A basic principal of market-based economic systems is that competition drives value. But the surge in mergers and acquisitions within the health care industry is causing a drastic reduction in competition among entities such as insurance companies, hospitals, physicians’ practices and even suppliers of services such as dialysis.
“In order for markets to work, you need many small buyers and sellers. What we’re actually seeing is consolidation,” said Leemore Dafny, professor of management and strategy and the Herman Smith Research Professor in Hospital and Health Services at Kellogg School of Management at Northwestern University in Chicago. Dafny delivered the 14th annual Marshall J. Seidman Lecture on the costs of health care consolidation.
Health care joint ventures, partnerships, mergers and acquisitions are front-page news around the country, including here in Boston, where a proposed acquisition of three community hospitals by Partner’s HealthCare has been postponed until November by a recent court order.
Dafny was one of 21 national anti-trust experts and health economists to sign a report calling on a Massachusetts judge to block Partner’s planned takeovers of South Shore Hospital and the two hospitals that make up the Hallmark Health System, based on her studies of competitive interactions among payers and providers of health care services and the intersection of industry and public policy.
In 2012-2013, Dafny served as Deputy Director for Healthcare and Antitrust in the Bureau of Economics at the Federal Trade Commission in Washington, D.C., where she oversaw investigations into anti-competitive practices in the industry.
Mergers can create value, from economies of scale or the convergence in a single system or network of providers with a multitude of sub-specialists covering diverse patient needs. But they can gain market share or revenue through anti-competitive practices like price-fixing, Dafny said.
Studies of hospitals, physicians groups, dialysis providers and health insurance mergers have shown that it is often the latter. Price and overall spending tends to increase, while quality in hospital and outpatient care show no increase, or even slight decreases, she said.
Dafny called on researchers and industry leaders to study the interactions between consolidations, benefit design and care delivery as a key aspect of efforts to create financially sustainable, high-value and high-quality health care systems and noted the need for innovative systems that promote integration without consolidation. The goal should be improved quality without the anticompetitive practices.
Should we have large-volume, discount-price providers for most things—like a Walmart for health—and boutique specialists for more complicated cases?
“Ideally, we would like the market to decide,” Dafny said. “The problem is, we’re going to need better shoppers.”
In 2000, on the occasion of his 50th reunion from Harvard Law School, Marshall J. Seidman provided endowment support to the Harvard Medical School Department of Health Care Policy to support research related to health care costs and quality and to host an annual meeting by a leading policy maker on issues related to costs and quality of health care with a particular emphasis on activities that are most likely to impact on federal and state approaches to these problems. The department has sponsored the lectures yearly since 2001.
The Science of Reform
In the midst of a transformation of health care in the United States, the Department of Health Care Policy at Harvard Medical School has launched the Health Care Markets and Regulation Lab to provide policy makers and industry leaders with the scientific evidence and analytical tools necessary to create a fiscally sustainable, high-quality health care system.
The lab’s first major initiative, supported by a $9.96 million grant from the Laura and John Arnold Foundation, officially begins on Oct. 1. Faculty in the lab will conduct seven research projects in the areas of health care payment reform, consumer engagement, delivery system reform, health care exchanges, quality measurement and risk adjustment. In addition, they will also directly engage both public sector and private industry leaders to help apply the best available science to reform efforts.
“We hope to not only provide scientific evidence about the effectiveness of reform efforts that are underway but to speed the translation of that science into action, shaping the implementation of regulations and guiding future iterations of reforms,” said Michael Chernew, HMS Leonard D. Schaeffer Professor of Health Care Policy, who will serve as director of the lab. “Ultimately, the goal is to create a higher quality, more efficient health care system.”
Barbara McNeil, Ridley Watts Professor of Health Care Policy and chair of the Department of Health Care Policy noted, “This funding puts us in the forefront of suggesting changes in the health care system by drawing together faculty from many parts of Harvard as well as individuals in the private and public sectors.”
The mission of the new lab is to provide the critical evidence and tools necessary to generate high-quality health care at a sustainable cost. To do this, faculty from the Department of Health Care Policy will join with experts from throughout the university, including a governance board that includes leaders in health care policy from the Harvard Business School, the Harvard School of Public Health, the Harvard Faculty of Arts and Sciences and the Harvard Kennedy School of Government.
The U.S. health care system is widely regarded as inefficient, with spending too high and quality too low. The leaders of the new lab note that this situation is due, in part, to the fee-for-service system of payment dominant in the U.S., which encourages providers to increase the volume of services rather than increasing the value of those services. In other words, rather than earning more by making patients healthier, providers earn more by doing more procedures.
At the same time, consumers—protected from the real costs of care by insurance that is subsidized by employers—have little incentive to shop for good deals in coverage or care.
Taken together, these inefficiencies have led to calls for reform of payment systems and development of better tools, such as insurance exchanges, to support markets and patient engagement, including those in the Affordable Care Act and various state and private reforms.
Supported by the Laura and John Arnold Foundation and other funders, members of the lab will lead studies in key reform areas and proactively engage policy makers and industry leaders to guide the implementation of reform.
“I don’t think any of us went into health care policy just to write papers,” Chernew said. “At core, we’re researchers, but in a world in the midst of great transformations, researchers must find new ways to make sure their work contributes to finding the best possible solutions. We want to be a part of transforming health care in a tangible way.”
“It's easy to complain about the failings of the health care system,” Chernew added. “Everybody knows there are problems. It’s much more important to figure out how to fix them.”
A new paper in Academic Medicine shows that a Harvard Medical School team-based primary care initiative at 19 local practices resulted in substantial improvement across all identified areas of transformation.
This novel, two-year learning collaborative, launched by the Harvard Medical School Center for Primary Care, consists of hospital- and community-based primary care teaching practices that serve more than 260,000 patients and train more than 450 residents in the greater Boston area.
In 2012, in response to a rapidly changing health care landscape, the Center for Primary Care, in partnership with local academic medical centers, established an academic innovations collaborative (AIC) to spur practice transformation across 6 Harvard-affiliated entities: Beth Israel Deaconess Medical Center, Brigham and Women’s Hospital, Cambridge Health Alliance, Boston Children’s Hospital, Massachusetts General Hospital and Mount Auburn Hospital.
The center built a collaborative structure and learning model in concert with Qualis Health and the Institute for Healthcare Improvement that has made a demonstrable change in the ways that practices function and engage patients and trainees in transformation.
“In two years we have successfully created a dynamic learning community that promotes team-based care and has fundamentally transformed care at 19 complex academic medical practices that serve diverse patients populations in the greater Boston area,” said Andrew Ellner, co-director of the Center for Primary Care and HMS assistant professor of medicine at Brigham and Women's.
“This level of collaboration across hospital systems is unprecedented in our community and holds tremendous promise for the future,” Ellner said.
Through the AIC, practices made substantial (more than 25 percent) and statistically significant improvement in scores across all areas of practice function on the validated Patient-Centered Medical Home Assessment tool including:
- Team-based primary care
- Leadership engagement
- Quality improvement
- Evidence-based care
- Patient engagement
- Care coordination
Important factors for success included leadership development, practice-level resources, and engaging patients and trainees.
“Lately, some health experts have been debating whether the patient-centered medical home is ‘the answer’ to the challenges primary care faces. Our work suggests that the AIC model of change shows promise as a path for academic medical centers to catalyze health system transformation through primary care improvement,” said Asaf Bitton, faculty lead for transformation strategy and design in the academic innovations collaborative and assistant professor of medicine at Brigham and Women's.
In addition to next steps for further evaluating the impact of practice transformation on quality measures and costs, expansion of the AIC model will require support from academic medical centers and payers, and the application of similar approaches on a broader scale in other medical training environments.
“The work of the AIC is not done. We are now entering a second phase, in partnership with CRICO/Risk Management Foundation of the Harvard Medical Institutions, in which we will focus on expanding team-based care to further optimize patient safety and care,” said Ellner. “We look forward to learning how a novel collaborative of this nature can help us provide the highest possible standard of primary care.”
About the Center for Primary Care
The HMS Center for Primary Care was launched on October 28, 2010. The center’s mission is to improve the health of our communities through transformation in primary care practice and education. Learn more at: https://primarycare.hms.harvard.edu/
Unintended Danger from Antidepressant Warnings
Researchers have found that U.S. Food and Drug Administration warnings about a potential danger for young people taking antidepressants may have backfired, causing an increase in suicide attempts by teens and young adults.
The 2003 warnings drew intense and possibly exaggerated media coverage that led to a sudden, steep decline in the number of prescriptions for antidepressants without offsetting increases in other effective treatments. In a study published in BMJ, researchers at Harvard Medical School’s Department of Population Medicine and the Harvard Pilgrim Health Care Institute report that in the year following the warnings, when antidepressant prescriptions fell by more than a fifth among young people, there was a relative increase of 21.7 percent in suicide attempts by overdose with psychotropic drugs, and 33.7 percent among young adults.
“This study is a one of the first to directly measure a health outcome driven by the interaction of public policy and mass media,” said Christine Lu, HMS instructor in population medicine at Harvard Pilgrim Health Care Institute and lead author of the study. “The FDA, the media and physicians need to find better ways to work together to ensure that patients get the medication that they need, while still being protected from potential risks.”
“This is an extraordinarily difficult public health problem, and if we don’t get it right, it can backfire in serious ways,” said co-author Stephen Soumerai, HMS professor of population medicine at Harvard Pilgrim Health Care Institute.
In 2003, an analysis that combed through all the existing clinical trials noted that approximately 1 percent of adolescents and young adults taking antidepressants experienced an increase in thinking about suicide.
The original warning, which was heavily publicized in news reports, mentioned only this potential risk of antidepressants to patients without noting the potential risk of undertreatment of depression.
These well-intended safety warnings became frightening alarms to clinicians, parents and young people, the researchers note, with many prominent media outlets warning that these drugs raised the risk of suicide. However, the FDA-cited studies showed only an increase in the risk of suicidal thoughts, not in attempted or completed suicide. In fact, as more young people were prescribed antidepressants in the years before the warning was issued, suicide attempts by young people were stable, the researchers said.
The FDA later revised the warning to recommend that physicians consider both the risk of prescribing the medication and the risk of not prescribing the medication, monitoring patients for thoughts of suicide and treating them as needed.
“These drugs can be very effective,” Soumerai said. “The media concentrated more on the relatively small risk than on the significant upside.”
The risks cited by the FDA were about 1 percent of those treated, but antidepressant use dropped suddenly by about a relative 20 percent, unintentionally leaving many depressed young people without appropriate treatment, which likely drove the accompanying hospital and emergency department admissions for suicide attempts, he said.
The researchers analyzed claims data for the years 2000 to 2010 from 11 health plans in the U.S. Mental Health Research Network, using a “virtual data warehouse” with anonymous patient data organized to facilitate sharing and data comparison between health systems. The study cohorts included 1.1 million adolescents, 1.4 million young adults and 5 million adults.
The researchers used overdose with psychotropic drugs as a conservative measure of suicide attempts. Completed suicides are very rare, so the researchers were not surprised to find no change in their 7.5 million patient sample.
The researchers noted that suicide attempts with drug overdose are very serious, resulting in long-term hospitalization and significant disruption to the lives of patients and their families.
“We need to do a better job of understanding and communicating the risks of taking—and not taking—medications,” Lu said.
This research was supported by a cooperative agreement (U19MH092201) with the U.S. National Institute of Mental Health.
All authors have support from the National Institute of Mental Health for the submitted work. Individual authors also report receiving grants and personal fees from Policy Analysis Inc. and Bristol-Myers Squibb outside this work.
$1.9 Billion in Medicare Waste: ‘Tip of the Iceberg’
In the first large-scale study to directly measure wasteful spending in Medicare, researchers found that Medicare spent $1.9 billion in 2009 for patients to receive any of 26 tests and procedures that have been shown by empirical studies to offer little or no health benefit.
By analyzing Medicare claims data, researchers in the Harvard Medical School Department of Health Care Policy found that at least one in four Medicare recipients received one or more of these services in 2009. What’s more, those 26 services are just a small sample of the hundreds of services that are known to provide little or no medical value to patients in many circumstances.
The researchers said that the methods utilized in the study will provide useful tools for measuring the effectiveness of reform efforts, like those in the Affordable Care Act, aimed at reducing wasteful spending in Medicare and across the health care system.
Health care spending in America is at an all-time high and continues to rise. Efforts to curb wasteful spending in Medicare and throughout the health care system are crucial to attempts to reduce spending while improving or at least preserving quality of care.
“We were surprised that these wasteful services were so prevalent,” said Aaron Schwartz, an MD/PhD student in the HMS Department of Health Care Policy and lead author of the study. “Even just looking at a fraction of wasteful services and using our narrowest definitions of waste, we found that one quarter of Medicare beneficiaries undergo procedures or tests that don’t tend to help them get better.”
Previous attempts to measure waste in Medicare and other health care systems have relied on comparing overall spending rates between matched patient populations in different geographical areas. The difference between the higher and lower spending areas is attributed to waste. In addition to giving researchers and policy makers a tool to more precisely measure existing waste, the methods used by the researchers can also provide important feedback on reforms designed to curb waste.
Hard to define
Some of the services studied—like arthroscopic debridement for knee osteoarthritis and a form of back surgery that involves filling collapsed disks with cement—almost never provide any health benefit to patients, and are almost always wasteful, according to recent empirical studies of the effectiveness of the procedures. Others are often wasteful but can provide profound benefits for patients in particular clinical circumstances. Lower back imaging for general back pain offers little benefit to patients with muscle soreness, but it can be lifesaving when used to identify cancer or a spinal abscess.
Choosing from hundreds of services that have been found to have little clinical value, the researchers identified 26 that would be detectable using the kind of information available in Medicare claims data. They then searched for examples of the 26 services that were likely wasteful among the claims records of 1,360,908 Medicare beneficiaries from 2009.
The researchers found that varying the criteria used to count wasteful instances of a service can substantially influence the amount of waste measured. A narrower definition would exclude likely beneficial cases but would miss counting some instances of waste. A broader definition would capture more instances of wasteful use, but would also inadvertently count some services that were medically beneficial.
The estimate of overall waste with the narrower criteria found that 25 percent of beneficiaries received at least one of the wasteful services, resulting in a total of $1.9 billion in Medicare spending. The broader version found that 42 percent of beneficiaries were affected at a cost of $8.5 billion in potentially wasteful spending.
“One of the things we learned from this study is that measuring waste is hard,” Schwartz said. “How much waste you find varies greatly depending on how you define it. Removed from the clinical details of a particular patient, it is hard to know whether a given procedure might be useful or not.”
“Because the value of a service depends on the patient, it is challenging to devise payment and coverage policies that limit wasteful care but not valuable care. Some tests and treatments that are wasteful across the board are easy targets—we can stop paying for them. But for most services, incentives that allow providers greater discretion at the point of care may be needed to cut significant amounts of waste while minimizing unintended consequences,” said McWilliams, who is also a practicing general internist at Brigham and Women’s Hospital
Instead of limiting care through coverage design or payment restrictions, the researchers see potential in global payment models that replace fee-for-service reimbursement with incentives to keep spending within a global budget and improve quality of care. These models could allow physicians and provider organizations to use more detailed clinical information to identify many more low-value services while encouraging their elimination. There are numerous low-value services—identified for example by specialty societies through campaigns like Choosing Wisely—that are difficult to measure well with claims data but could nevertheless be targeted by such broader payment reforms.
“That’s the theory behind reform experiments being implemented under the Affordable Care Act and through private insurers,” Schwartz said. “It’s exciting that we now have a tool to measure how well global budgets and similar reforms perform at the specific task of cutting wasteful spending.”
Funding: Supported by grants from the Beeson Career Development Award Program (National Institute on Aging K08 AG038354 and the American Federation for Aging Research), Doris Duke Charitable Foundation (Clinical Scientist Development Award #2010053), National Institute on Aging (P01 AG032952), Agency for Healthcare Research and Quality Institutional Training Grant (2T32HS000055-20), Harvard University (Christopher G.P. Walker Fellowship), and the Australian National Health and Medical Research Council Sidney Sax Public Health Fellowship (627061).
The Mammography Dilemma
A comprehensive review of 50 years’ worth of international studies assessing the benefits and harms of mammography screening suggests that the benefits of the screening are often overestimated, while harms are underestimated. And, since the relative benefits and harms of screening are related to a complex array of clinical factors and personal preferences, physicians and patients need more guidance on how best to individualize their approach to breast cancer screening.
The results of the review by researchers at Harvard Medical School’s Department of Health Care Policy and Brigham and Women’s Hospital are published today in JAMA.
The American Cancer Society estimates that about 40,000 U.S. women will die of breast cancer this year. In 2009, based on evidence that the benefit-risk ratio for mammography screening is higher among women over 50 and with less frequent screening, the U.S. Preventive Services Task Force (USPSTF) reversed its previous recommendation of mammography every one to two years beginning at age 40, and recommended routine screening every two years starting at age 50, the researchers noted. The recommendations remain controversial among the general public and the medical community. Recent evidence suggests that use of mammography in the U.S. has not changed following the updated recommendations.
“What I tell my patients is that the mammogram is not a perfect test,” said Nancy Keating, co-author of the report, associate professor of Health Care Policy at HMS and associate professor of medicine at Brigham and Women’s. “Some cancers will be missed, some people will die of breast cancer regardless of whether they have a mammogram, and a small number of people that might have died of breast cancer without screening will have their lives saved.”
The authors report that the best estimate of the reduction in mortality from breast cancer due to annual screening for women overall is about 19 percent. For women in their 40s, the reduction in risk was about 15 percent, and for women in their 60s, about 32 percent. But how much a woman benefits depends on her underlying risk of breast cancer. Moreover, mammography is associated with harms that may be shared by all women who receive the screening tests, not just the women who eventually benefit from them.
The researchers estimated that among 10,000 women in their 40s who undergo annual mammography for 10 years, about 190 will be diagnosed with breast cancer. Of those 190, the researchers estimate that about 5 will avoid death from breast cancer due to screening. About 25 of the 190 would die of breast cancer regardless of whether they have a mammogram or not. The rest will survive, thanks largely to advances in breast cancer treatment.
However, according to Keating, the chief harm associated with mammography is the risk of overdiagnosis. This is the diagnosis of cancers that never would have become clinically evident during a woman’s lifetime, either because the cancer never grew or because the patient died first of another cause. While it is impossible with current techniques to know which cancers we could safely observe and which need to be treated, the review cites findings that roughly 19 percent of women who are diagnosed based on findings from a mammogram are overdiagnosed. That means that roughly 36 of the 190 women who received annual mammography for 10 years and were diagnosed with breast cancer would receive unnecessary surgery, chemotherapy or radiotherapy.
In addition, more than half of women who get annual screenings for 10 years can expect to have a false positive mammogram that requires additional images, and about 20 percent of these false positives result in unnecessary biopsies. Studies show these false positives cause some short-term anxiety, but there is not consensus about lasting harm.
“While we need more research on mammography’s benefits and harms today, existing data suggest that we have been overestimating the benefits of mammography and underestimating the harms over the years,” said co-author Lydia Pace, research fellow in Women’s Health at Brigham and Women’s. “It is really important to have informed discussions with our patients to help them understand the chances that a mammogram will benefit them as well as the possible downsides of getting a mammogram, so that they can incorporate their own values and preferences in making the right decision for themselves.”
Breast cancer risk rises with age, so women in their 50s and 60s receive more benefit relative to the risk of harm. Other factors, including family history and whether and when a woman has given birth, also change a woman’s risk/benefit ratio.
Keating emphasized the importance of individualizing screening recommendations based on a patient’s personal profile. Overdiagnosis is a particular concern among women with limited life expectancies, either due to age or some other condition. “I have 80-year-olds in my practice with life expectancies of 15 or 20 years, and 60-year-olds who will likely only live another year or two,” she said. “Those two kinds of patients need different recommendations about whether to continue screenings, and it can’t be based simply on the patient’s age.”
The researchers said that they hope that this systematic review of the literature on the risks and rewards of mammography for patients will help physicians understand the complex data, and will encourage the development and use of tools for customizing the information they share with their patients to meet each patient’s individual needs. The researchers also noted that more work needs to be done to fully understand the harms of mammography.
Pace’s effort on this review was funded by the Global Women’s Health Fellowship at Brigham and Women’s Hospital.
Suicidal Ideation Among U.S. Soldiers Precedes Enlistment
Nearly 60% of soldier suicide attempts can be traced to pre-enlistment mental disorders, which are much more common among nondeployed U.S. Army soldiers than demographically similar populations of civilians (25.1% vs. 11.6%), according to a major new study. The vast majority (76.6%) of soldiers with mental disorders say their conditions started before enlistment, researchers found.
These are among the initial results published online today in JAMA Psychiatry based on a survey carried out as part of the Army Study to Assess Risk and Resilience in Servicemembers (Army STARRS), the largest study of mental health risk and resilience ever conducted among U.S. Army personnel.
Although the suicide death rate in the U.S. Army has historically been below the civilian rate, the Army rate began climbing at the beginning of the Iraq and Afghanistan conflicts, and by 2008, it exceeded the demographically matched civilian rate (20.2 suicide deaths per 100,000 vs. 19.2). Concerns about this increase led to Army STARRS, a partnership between the Army and the NIMH designed to help understand and address this issue. The initial findings published today include three papers that use different strategies to evaluate suicide risk and protective factors among service people, including an analysis comparing the prevalence of mental disorders among Army and civilian populations.
“Some of the differences in disorder rates are truly remarkable,” said Ronald Kessler, McNeil Family Professor of Health Care Policy at Harvard Medical School and senior author of the paper on mental disorder prevalence. “The rate of major depression is 5 times as high among soldiers as civilians, intermittent explosive disorder 6 times as high, and PTSD nearly 15 times as high.”
The most common disorders in the Army STARRS survey were attention deficit hyperactivity disorder (ADHD) and intermittent explosive disorder (IED), or recurrent and uncontrollable anger attacks, Kessler said.
The findings suggest that soldiers did not have higher rates of most “internalizing disorders” (anxiety disorders and depression) than civilians before enlistment, but rather developed high rates of these disorders only after they enlisted in the Army. The situation was different, though, for “behavioral disorders” (ADHD, IED and substance abuse), which were much more common among young people who subsequently enlisted in the Army than those who did not. Rates for these disorders increased even more after enlistment. Nearly half of current soldier internalizing disorders and 80% of behavioral disorders started before enlistment.
“These results are a wake-up call highlighting the importance of outreach and intervention for new soldiers who enter the Army with pre-existing mental disorders,” said Robert Ursano, Chair of the Department of Psychiatry at the Uniformed Services University of the Health Sciences and co-principal investigator of Army STARRS.
A second Army STARRS paper appearing today in JAMA Psychiatry revealed that 13.9% of soldiers considered suicide at some point in their lifetime, 5.3% had made a suicide plan, and 2.4% had attempted suicide, with between 47% to 60% of these outcomes first occurring prior to enlistment. Pre-existing mental disorders were found to be by far the strongest predictors of these suicidal behaviors.
“It is striking that nearly 50% of the soldiers who attempted suicide made their first attempt before joining the Army, as applicants are asked about any history of suicide attempts in recruitment interviews and those who report such a history typically are excluded from service,” said Matthew Nock, professor of psychology at Harvard University and lead author of this report on soldier suicidality.
Nock noted that the most practical implication of this finding might be that the Army should develop outreach and intervention programs for new soldiers based on the realization that a nontrivial proportion of new soldiers come into the Army with a history of mental disorder and suicidality, and that applicants are not always forthcoming about these concerns during the recruitment process.
The researchers added that intermittent explosive disorder is of special importance because it was the only disorder found to predict suicide attempts after developing suicidal thoughts, which has important implications for screening and prevention. This important finding shows that it is not only depression and PTSD that predict suicide attempts.
A third JAMA Psychiatry article by lead author Michael Schoenbaum of NIMH examined the suicide and accident death rates in relation to basic sociodemographic and Army experience factors in the 975,057 regular Army soldiers who served between Jan. 1, 2004, and Dec. 31, 2009, charting variations in the rates based on a variety of factors including sex, race, education level and rank.
The Army Study to Assess Risk and Resilience in Servicemembers (Army STARRS) is funded by the U.S. Army and the National Institute of Mental Health. The study is led by co-principal investigators Robert J. Ursano (Uniformed Services University of the Health Sciences) and Murray B. Stein (University of California, San Diego), with site investigators Steven G. Heeringa (University of Michigan) and Ronald C. Kessler (Harvard Medical School), and with collaborating scientists Lisa J. Colpe (NIMH), and Michael Schoenbaum (NIMH). More information at: http://www.armystarrs.org/media_room