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OBJECTIVES: To compare Medicare Advantage (MA) and traditional Medicare (TM) performance on quality, health, and cost outcomes in peer-reviewed literature published since 2010. STUDY DESIGN: Systematic review of peer-reviewed papers published between January 1, 2010, and May 1, 2020. METHODS: To identify relevant research papers, we searched MEDLINE, EBSCO, and ProQuest. We excluded any studies that did not meet several inclusion criteria. Titles, abstracts, and full-text articles were independently reviewed by 1 author and several trained research assistants. Disagreements were resolved through discussion. We also reviewed the bibliographies of included studies and consulted subject matter experts to identify additional papers. For each eligible study, we extracted the first author, year published, study design, data sources, study years, sample sizes, relevant measures, and study quality. To ensure consistent and complete data extraction, each article was reviewed by 2 reviewers. Study quality was assessed using a modified Newcastle-Ottawa Scale. RESULTS: Thirty-five studies including 208 analyses were included. All included studies were observational. Two-thirds of studies were of high methodological quality for observational studies, and 49% addressed selection bias. Analyses compared quality of care (41%), health outcomes (44%), and spending (15%). Overall, 65% of analyses found a statistically significant relationship: 52% favored MA and 13% favored TM. CONCLUSIONS: More than half of recent analyses comparing MA and TM find that MA delivers significantly better quality of care, better health outcomes, and lower costs compared with TM. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To evaluate whether one summary metric of calculator performance sufficiently conveys equity across different demographic subgroups, as well as to evaluate how calculator predictive performance affects downstream health outcomes. STUDY DESIGN: We evaluate 3 commonly used clinical calculators--Model for End-Stage Liver Disease (MELD), CHA2DS2-VASc, and simplified Pulmonary Embolism Severity Index (sPESI)--on the cohort extracted from the Stanford Medicine Research Data Repository, following the cohort selection process as described in respective calculator derivation papers. METHODS: We quantified the predictive performance of the 3 clinical calculators across sex and race. Then, using the clinical guidelines that guide care based on these calculators' output, we quantified potential disparities in subsequent health outcomes. RESULTS: Across the examined subgroups, the MELD calculator exhibited worse performance for female and White populations, CHA2DS2-VASc calculator for the male population, and sPESI for the Black population. The extent to which such performance differences translated into differential health outcomes depended on the distribution of the calculators' scores around the thresholds used to trigger a care action via the corresponding guidelines. In particular, under the old guideline for CHA2DS2-VASc, among those who would not have been offered anticoagulant therapy, the Hispanic subgroup exhibited the highest rate of stroke. CONCLUSIONS: Clinical calculators, even when they do not include variables such as sex and race as inputs, can have very different care consequences across those subgroups. These differences in health care outcomes across subgroups can be explained by examining the distribution of scores and their calibration around the thresholds encoded in the accompanying care guidelines. [ABSTRACT FROM AUTHOR]

OBJECTIVES: This paper examines (1) the rate of plan switching among beneficiaries enrolled in a Medicaid managed long-term services and supports (MLTSS) program in Virginia, (2) barriers that prevent beneficiaries from changing plans, and (3) the extent to which a change in plans is associated with greater satisfaction with the current health plan. STUDY DESIGN: Survey data from a representative sample of 1048 members enrolled in Commonwealth Coordinated Care Plus, a Virginia Medicaid MLTSS program. METHODS: The survey ascertained whether beneficiaries changed plans at the previous open enrollment period, whether they wanted to change plans but did not, and reasons for not following through with a plan change. Logistic regression analysis examined the association between the intention to change plans and satisfaction with the current health plan. RESULTS: Seven percent of respondents changed plans during the previous open enrollment. However, twice as many respondents (15%) wanted to change plans but did not. The main reason for not changing plans was uncertainty about whether the new plan would meet their needs better than their current plan. Logistic regression analysis shows that an intention to change plans (realized or not) was associated with higher odds (3.5 times higher) of being dissatisfied with the current health plan compared with beneficiaries who had no intention to change plans. CONCLUSIONS: Greater dissatisfaction after a recent plan change may indicate that these members have specific needs beyond the scope of services offered by managed care organizations. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Because physicians' decisions drive health care costs and quality, there is growing interest in applying behavioral economics approaches, including behavioral nudges, to influence physicians' decisions. This paper investigates adoption of behavioral nudges by health system--affiliated physician organizations (POs), types of nudges being used, PO leader perceptions of nudge effectiveness, and implementation challenges. STUDY DESIGN: Mixed-methods study design (PO leader survey followed by in-depth qualitative interviews). Purposive sample of 30 health system--affiliated POs in 4 states; POs varied in size and quality performance. METHODS: We collected data between October 2017 and June 2019. The survey asked PO leaders to report their organization's use of 5 categories of nudges to influence primary and specialty physicians' actions. We conducted semistructured phone interviews to confirm survey responses, elicit examples of the nudges that POs reported using, understand how nudges were structured, and identify implementation challenges. We present descriptive tabulations of nudge use and effectiveness ratings. We applied thematic analysis to the interview data. RESULTS: Almost all POs in this study reported nudge use. Clinical templates, patient action lists, and altered order entry were most commonly used. However, PO leaders reported that nudge use was limited to a narrow range of clinical applications, not widespread across the organization, and mostly structured as suggestions rather than default actions or hard stops. CONCLUSIONS: Nudge use remains limited in practice. Opportunities exist to expand use of nudges to influence physician behavior; however, expanding use of behavioral nudges will require PO investment of resources to support their construction and maintenance. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Health care payers are increasingly experimenting with interventions to address social risk factors. With enactment of the 2018 Bipartisan Budget Act, Medicare Advantage (MA) plans have new opportunities to offer supplemental benefits that are not "primarily health- related." This article presents findings from interviews conducted with executives from MA plans regarding plan decision-making processes related to new social risk factor benefits. STUDY DESIGN: Semistructured qualitative interviews with MA plan leadership. METHODS: A total of 63 plan representatives from 29 unique MA plans were interviewed about the rationale for social risk-related interventions and how data are used to inform benefits expansion decisions. This paper combines qualitative interview data from 2 separate studies with similar target groups and interview guides. Interview transcripts were qualitatively analyzed to examine underlying themes. RESULTS: Three main themes emerged: (1) Plans use multiple data sources to determine how to target benefits; (2) evidence gaps hinder decision-making to expand or offer new supplemental benefits; and (3) in the absence of sufficient evidence, some plans have their own research and quality improvement processes to maximize effectiveness. CONCLUSIONS: Findings provide insights about opportunities and challenges that MA plans face in making decisions related to supplemental benefits designed to address members' social risk factors. Barriers include collecting, generating, and analyzing data critical to informing investments. Results highlight the need to ensure interoperability of new and existing data sources, foster shared learning opportunities, and narrow evidence gaps about specific social care interventions to inform the design and implementation of effective supplemental benefits. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Emergency department (ED) crowding poses a severe public health threat, and identifying acceptable means of treating medical conditions in alternative sites of care is imperative. We compared patients' experiences with in-home urgent care via mobile integrated health (MIH) vs urgent care provided in EDs. STUDY DESIGN: Survey, completed on paper, online, or by telephone. We surveyed all patients who received MIH care for an urgent health problem (n = 443) and consecutive patients who visited EDs for urgent care (n = 1436). METHODS: Study participants were members of a managed care plan who were dually eligible for Medicare and Medicaid, 21 years or older, and treated either by MIH or in an ED for nonemergent conditions around Boston, Massachusetts, between February 2017 and June 2018. The survey assessed patients' perceptions of their urgent care experiences. RESULTS: A total of 206 patients treated by community paramedics and 718 patients treated in EDs completed surveys (estimated 66% and 62% response rates, respectively). Patients treated by MIH perceived higher- quality care, more frequently reporting "excellent" (54.7%) or "very good" (32.4%) care compared with ED patients (40.7% and 24.3%, respectively; P < .0001), and were significantly more likely to report that decisions made about their care were "definitely right" compared with patients treated in the ED (66.1% vs 55.6%; P = .02). CONCLUSIONS: Patients appear satisfied with receiving paramedic-delivered urgent care in their homes rather than EDs, perceiving higher-quality care. This suggests that in-home urgent care via MIH may be acceptable for patients with nonemergent conditions. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Most transparency tools are provided by individual insurers for enrollees shopping for services within their networks. This paper seeks to understand the impact of a marketwide price transparency tool with an embedded randomized experiment to offer provider-level charge information. STUDY DESIGN: In September 2017, FAIR Health released an independent, publicly accessible statewide consumer shopping tool, New York Healthcare Online Shopping Tool, or NYHOST, that displays individual provider charges (list prices) for common procedures in each of New York State's 3-digit geozips, as well as the estimated insurer-allowed amounts and educational resources. The rollout was accompanied by an extensive, multipronged marketing effort. It also incorporated a randomized experiment: The set of procedures with provider-level information varied across areas. METHODS: We characterized the types of services that were most searched on the consumer shopping tool. Utilizing negative binomial models with procedure and area fixed effects, we report on market and procedural characteristics that influence price search. RESULTS: Consumers utilized the tool strategically, searching more in procedure markets with provider-specific price information availability, more frequent out-of-network utilization, higher charges, significant charge dispersion, and substantial provider competition. We also found that the majority of searches using the tool were for emergent services not usually classified as shoppable, suggesting that consumers may also have used the tool to compare searchable prices against those in bills for services already received. CONCLUSIONS: Our findings confirm aspects of price search theory that have been developed by studying other industries and may prove instructive for further study of price transparency tools. [ABSTRACT FROM AUTHOR]

Individuals with multiple chronic conditions (MCCs) represent a growing proportion of the adult population in the United States, particularly among lower-income individuals and people of color. Despite ongoing efforts to characterize this population and develop approaches for effective management, individuals with MCCs continue to contribute substantially to health care expenditures. Based on a review of recent literature, several identified barriers limit the effectiveness of care for patients with MCCs. Health care delivery system structural limitations, evidence-based care concerns, patient-clinician relationship constraints, and barriers to inclusion of patient-centered priorities may singly or in combination negatively affect outcomes for individuals with MCCs. The COVID-19 pandemic has shed further light on inequities contributing to suboptimal MCC patient management. Awareness of the prevalence and demographic attributes of patients with MCCs and the identified barriers to care may help improve patient engagement and treatment outcomes for this high-cost population. This paper provides recommendations for enhancing MCC patient care outcomes in the current and post--COVID-19 health care delivery settings. [ABSTRACT FROM AUTHOR]

Introduction: Approaches to treating heart failure (HF), understanding of the most timely and effective interventions, and identification of appropriate patient subpopulations must evolve. HF has emerged as a chronic condition that needs to be managed on multiple fronts. Hospital resources are more limited than ever due to various factors that directly impact staff and hospital space available to manage and treat patients with HF. As a result, there is increasing attention to the current state of this progressive disease and ways to improve patient outcomes., Purpose: This paper examines HF and the current and future treatment landscape, the need to reevaluate terms and definitions, and the opportunity to treat HF with the right treatment at the right time. Treatments in development and potential new investigational therapies are also discussed., Conclusion: To meet the current challenge, HF treatment must adapt. For other disease states, we have more personalized, nimble, and timely treatment strategies that harness windows of opportunity to help maximize outcomes and reduce overwhelming costs to the health care system. HF treatment is evolving with new guidelines and treatments that hold the promise of greater personalization through additions to existing treatments that are directed by medical guidelines, since each patient is unique and requires more than a one-size-fits-all approach. In addition, advances in remote monitoring, in-home care, and telemedicine are creating a more individualized treatment approach. Therefore, it becomes critical for all health care decision makers to be aware of the tools and resources available in treatment guidelines, individualized treatment options, telemedicine, and other ways of expanding the existing toolbox to enhance patient centricity in HF treatment.

Objectives: The study's objectives were to explore the impact of personal/organizational knowledge, prior breach status of organizations, and framed scenarios on the choices made by privacy officers regarding the decision to report a breach., Study Design: A survey was completed of 123 privacy officers who are members of the American Health Information Management Association (AHIMA)., Methods: The study used primary data collection through a survey. Individuals listed as privacy officers within the AHIMA were the target audience for the survey. Descriptive statistics, logistic regression, and predicted probabilities were used to analyze the data collected., Results: The percentage of privacy officers who chose to report a breach to the Office for Civil Rights varied by scenario: scenario 1 (general with little information), 39%; scenario 2 (4-factor risk assessment, paper records), 73.2%; scenario 3 (4-factor risk assessment, ransomware case), 91.9%. Several factors affected the response to each scenario. In scenario 1, privacy officers with a Certified in Healthcare Privacy and Security (CHPS) credential were less likely to report; those who previously reported a prior breach were more likely to report. In scenario 2, privacy officers with a bachelor's degree or graduate education were less likely to report; those who held the CHPS or coding credential were less likely to report., Conclusions: Study findings show there are gray areas where privacy officers make their own decisions, and there is a difference in the types of decisions they are making on a day-to-day basis. Future guidance and policies need to address these gaps and can use the insight provided by the results of this study.

Objectives: There is an ongoing policy discussion regarding an adequate breadth of provider networks. Health plans with "restricted networks" of providers have proved surprisingly popular on the Affordable Care Act health insurance exchanges because of a substantial gap in premiums between plans with open networks and closed networks. The objective of this paper is to assess which other attributes of the provider network matter to patients when choosing health insurance., Study Design: We used a discrete choice experiment to analyze the effect of previously unobserved characteristics regarding provider networks on plan choice, including wait time, breadth, travel time, whether the plan covers care for their personal doctor, and monthly premium. Hypothetical plan options were offered to respondents of an online survey using Qualtrics software., Methods: We used mixed multinomial logit models to estimate preference-based utilities for attributes of primary care provider networks and willingness to pay., Results: Coverage of a personal doctor was the most important attribute, followed by premium, wait time to see a primary care provider, the breadth of the network, and travel time to the closest doctor covered by the plan. Respondents were willing to pay $95 per month to have a plan that covers care for their personal doctor, and they were willing to wait 6 days for an appointment to have a plan covering care for their personal doctor., Conclusions: The results of this study provide new insights to federal and state legislators developing new models or standards on network adequacy and patient decision support tools.

The learning health system (LHS) has gained traction as a powerful framework for improving the cost and quality of healthcare. The goal of an LHS is to systematically integrate internal data and experience with external evidence so patients receive higher-quality, safer, and more efficient care. However, if the goal of an LHS is to improve health, as well as healthcare, it must account for and mitigate the negative impact of social and economic factors on health, known as the social determinants of health. In this paper, we discuss the critical role the LHS can play in addressing patients' social risk factors. We also discuss how integrating data on the social determinants and activities to reduce patients' social risk factors could advance the mission of the LHS to enhance patient engagement, improve the delivery of personalized care, and more accurately evaluate the effectiveness of care. Without the collection and integration of data on the social determinants of health, the LHS may fail to reach its full potential to improve health and healthcare.

Objectives: This paper aims to synthesize existing scholarship on quality measures in oncology, with a specific focus on outcome-based quality measures, which are often underutilized. We also present a set of "core outcome measures" that may be considered in future oncology alternative payment models (APMs)., Study Design: Our research consists of a focused literature review, content analysis, and quality measure synthesis and categorization., Methods: We conducted a focused literature review to generate key evidence on quality measures in oncology. We studied 7 oncology quality assessment frameworks, encompassing 142 quality metrics, and synthesized recommendations using the Center for Medicare and Medicaid Innovation APM toolkit, focusing on outcome measures., Results: We present 34 outcome-based oncology quality measures for consideration, which are classified into 5 domains: clinical care (eg, hospital and emergency department visits, treatment effectiveness, mortality), safety (eg, infections, hospital adverse events), care coordination (for hospital and hospice care), patient and caregiver experience, and population health and prevention. Both general and indication-specific outcome measures should be considered in oncology APMs, as appropriate. Utilizing outcome-based measures will require addressing multiple challenges, ranging from risk adjustment to data quality assurance., Conclusions: Oncology care will benefit from a more rigorous approach to quality assessment. The success of oncology APMs will require a robust set of quality measures that are relevant to patients, providers, and payers.

Objectives: We conducted a systematic review of studies reporting the direct healthcare costs of treating older adults with diagnosed Alzheimer disease and related dementias (ADRD) within private Medicare managed care plans., Study Design: A systematic review of all studies published in English reporting original empirical analyses of direct costs for older adults with ADRD in Medicare managed care., Methods: All papers indexed in PubMed or Web of Science reporting ADRD costs within Medicare managed care plans from 1983 through 2018 were identified and reviewed., Results: Despite the growth in Medicare managed care enrollment, only 9 papers report the costs of care for individuals with ADRD within these plans, and only 1 study reports data less than 10 years old. This limited literature reports wide ranges for ADRD-attributable costs, with estimates varying from $3738 to $8726 in annual prevalent costs and $8938 to $38,794 in 1-year immediate postdiagnosis incident costs. Reviewed studies also used varied study populations, case and cost ascertainment methods, and analytic methods, making cross-study comparisons difficult., Conclusions: The expected continued growth in Medicare managed care enrollment, coupled with the large and growing impact of ADRD on America's healthcare delivery and finance systems, requires more research on the cost of ADRD within managed care. This research should use more consistent approaches to identify ADRD prevalence and provide more detail regarding which components of care are included in analyses and how the costs of care are captured and measured.

Objectives: There is robust evidence that implementation of reference-based pricing (RBP) benefit design decreases spending. This paper investigates employer adoption of RBP as a strategy to improve the value of patients' healthcare choices, as well as facilitators and barriers to the adoption of RBP by employers., Study Design: We conducted a qualitative study using 12 in-depth interviews with human resources executives or their representatives at large- or medium-sized self-insured employers., Methods: Interviews were conducted and recorded over the phone between March 2017 and May 2017. Interviewees were asked about their adoption of RBP and facilitators and barriers to adoption. We applied thematic analysis to the transcripts., Results: Despite broad employer awareness of RBP's potential for cost savings, few employers are including RBP in their benefit design. The major barriers to RBP adoption were the complexity of RBP benefit design, concern that employees could face catastrophic out-of-pocket costs, lack of a business case for implementation, and concern that RBP could hurt the employer's competitiveness in the labor market. The few employers that have adopted RBP have implemented extensive, year-round employee education campaigns and invested in multipronged and proactive decision support to help employees navigate their choices., Conclusions: Unless several fundamental barriers are addressed, uptake of RBP will likely continue to be low. Our findings suggest that simplifying benefit design, providing employees protection against very high out-of-pocket costs, understanding which decision-support strategies are most effective, and enhancing the business case could facilitate wider employer adoption of RBP.

Objectives: To characterize the drivers of the use of electronic health information exchange (HIE) by skilled nursing facilities (SNFs) to access patient hospital data during care transitions., Study Design: Explanatory, sequential mixed-methods study. Quantitative data from an audit log captured HIE use by 3 SNFs to retrieve hospitalization information for the 5487 patients discharged to their care between June 2014 and March 2017, along with patient demographic data. Qualitative inquiry included 16 interviews at the discharging hospital and HIE-enabled SNFs., Methods: Multivariate probit models determined patient-level factors associated with SNF HIE use. These models informed subsequent in-depth, semistructured interviews to refine our understanding of usage patterns, as well as facilitators of and barriers to use., Results: HIE was used by SNFs for 46% of patients for whom it was available; 29% of patients had records accessed within 3 days of hospital discharge. Overall HIE use was more likely for new versus returning SNF patients (3.8%; P <.001) and when a patient was discharged from the emergency department rather than an inpatient unit (6.8%; P = .027). HIE use was less likely on weekends (-4.3%; P = .036) and for more complex patients, as measured by length of stay (-0.4% per day; P ≤.001) or number of conditions (-0.3% per diagnosis; P ≤.001). Interviews revealed distinct HIE use cases across SNFs; perceiving ability to access information not otherwise available in paper discharge materials, as well as workflow integration, were critical facilitators of use during transitional care., Conclusions: HIE between hospitals and SNFs is underused. A mixed-methods approach is critical to understanding and explaining variation in implementation and use. Creating value requires hospitals and SNFs to codevelop system design, usage guidelines, and workflows that meaningfully integrate HIE into care delivery.

Objectives: Behavioral health conditions and social problems are common yet underrecognized among emergency department (ED) patients. Traditionally, ED-based behavioral health screening is limited. We evaluated the feasibility of expanded behavioral health screening by a trained nonclinician., Study Design: Prospective observational study of a convenience sample of ED patients., Methods: A research assistant (RA) approached a convenience sample of adult ED patients within an integrated healthcare delivery system. Patients completed a paper screening instrument (domains: mood, anxiety, alcohol use, drug use, sleep, intimate partner violence, and chronic pain) and reviewed responses with the RA, who shared positive screening results with the treating ED physician. We abstracted behavioral health and medical diagnoses from the electronic health record (EHR), comparing the screened cohort with the eligible population. We used χ2 tests to assess differences in demographics and comorbidities between screened patients and the eligible group and differences between self-reported symptoms and EHR diagnoses among screened patients., Results: Among 598 screened patients, the prevalence of self-reported symptoms was higher than that of associated EHR diagnoses in the year prior to the ED visit (anxiety, 45% vs 19% [P <.001]; depression, 40% vs 22% [P <.001]; drug use, 7% vs 4% [P = .011]; risky alcohol use, 12% vs 5% [P <.001]; chronic pain, 47% vs 30% [P <.001]; and sleep problems, 47% vs 4% [P <.001])., Conclusions: A dedicated RA was able to integrate screening into patient idle times in the ED visit. The prevalence of behavioral health problems was higher than indicated in the EHR.

Socioeconomic status (SES), an important determinant of individual health status, has not been widely incorporated into employer benefits strategies. Recent research has characterized significant differences in healthcare utilization patterns and cost among workers in different wage categories, raising the possibility that SES does influence individual healthcare utilization behaviors. In particular, SES may have appreciable impact on the effectiveness of benefits tactics, including value-based insurance design (VBID). This paper sets forth a hypothesis that low wage status negatively influences individual receptivity to VBID offerings, which may blunt the impact of current VBID initiatives. In contrast, high-wage earners may already be compliant with recommended care, and implementation of a VBID design may not yield incremental increases in their treatment compliance. As a result, wage status may be a significant predictor of a favorable response to VBID. Based on these considerations, the authors offer suggestions for employer actions, including evaluation of benefits enrollee response to VBID tactics by employee wage band as an initial step. Employers may also wish to engage benefits enrollees via survey or focus group activities to understand barriers to a more impactful VBID response and consider some of the included benefits design considerations that may result in more equitable and impactful use of VBID. Further research is needed to better understand the relationship between SES and response to VBID offerings.

Objectives: In January 2014, Nevada became 1 of the 32 states that have expanded Medicaid under the Affordable Care Act. As a result of the expansion, 276,400 additional Nevada residents received Medicaid insurance. The objectives of this paper were to examine the impact of Nevada's Medicaid expansion on changes in rates of hospital admissions for ambulatory care-sensitive conditions (ACSCs), which are potentially preventable with good access to outpatient medical care, and to examine the racial/ethnic disparities in such rates., Study Design: We used complete inpatient discharge data (for the years 2012, 2013, and 2014, and the first 3 quarters of 2015) from all nonfederal acute care community hospitals in Nevada., Methods: We employed pooled cross-sectional design with a difference-in-differences approach to identify overall and race/ethnicity-specific changes in admissions for ACSCs, adjusted for secular trends unrelated to expansion. We examined admissions for ACSCs among adults aged 18 to 64 years (those most likely to have been affected by the reform) admitted for overall, acute, and chronic ACSC composites in the 24 months before and 21 months after the date on which expansion was implemented., Results: After adjusting for confounders, we found that Hispanic patients with Medicaid were more likely to be admitted for ACSCs after Nevada's Medicaid expansion (overall quality composite: odds ratio [OR], 1.20; P = .05; chronic quality composite: OR, 1.34; P = .02)., Conclusions: This analysis provides evidence that Medicaid expansion may have limited potential to reduce the disparities in rates of hospital admissions for ACSCs. In Nevada, additional efforts might be needed to improve access to outpatient care and reduce preventable admissions.

A limited distribution network (LDN) restricts the distribution channel for a pharmaceutical drug to 1 or a very small number of distributors. This strategy may allow for more effective allocation of drugs in shortage and is purported to help ensure the safe distribution of high-risk drugs to small patient populations. However, in recent years, some drug companies, including Turing Pharmaceuticals, have used LDNs to prevent generic and biosimilar companies from accessing samples of drug products necessary to perform testing required by the FDA for generic and biosimilar drug applications. LDNs also hamper provider access to pharmaceuticals and facilitate price gouging. This paper synthesizes existing knowledge on the misuse of LDNs to thwart competition, clarifies the relationship between limited distribution and the FDA Risk Evaluation and Mitigation Strategies, discusses proposed federal legislation under consideration to address this issue, and offers several policy options to remedy this anticompetitive practice, including authorizing the FDA to require the sale of approved drug products to generic and biosimilar drug developers.

This supplement showcases the winning papers from the PAN Challenge, which aimed to foster conversations about how to rein in out-of-pocket costs to eliminate barriers between patients and their critical medical treatments.

Objectives: The objectives of this study were to describe the locations in hospitals where data are breached, the types of breaches that occur most often at hospitals, and hospital characteristics, including health information technology (IT) sophistication and biometric security capabilities, that may be predicting factors of large data breaches that affect 500 or more patients., Study Design: The Office of Civil Rights breach data from healthcare providers regarding breaches that affected 500 or more individuals from 2009 to 2016 were linked with hospital characteristics from the Health Information Management Systems Society and the American Hospital Association Health IT Supplement databases., Methods: Descriptive statistics were used to characterize hospitals with and without breaches, data breach type, and location/mode of data breaches in hospitals. Multivariate logistic regression analysis explored hospital characteristics that were predicting factors of a data breach affecting at least 500 patients, including area characteristics, region, health system membership, size, type, biometric security use, health IT sophistication, and ownership., Results: Of all types of healthcare providers, hospitals accounted for approximately one-third of all data breaches and hospital breaches affected the largest number of individuals. Paper and films were the most frequent location of breached data, occurring in 65 hospitals during the study period, whereas network servers were the least common location but their breaches affected the most patients overall. Adjusted multivariate results showed significant associations among data breach occurrences and some hospital characteristics, including type and size, but not others, including health IT sophistication or biometric use for security., Conclusions: Hospitals should conduct routine audits to allow them to see their vulnerabilities before a breach occurs. Additionally, information security systems should be implemented concurrently with health information technologies. Improving access control and prioritizing patient privacy will be important steps in minimizing future breaches.

One in 10 infants in the United States is delivered preterm (ie, before the 37th week of pregnancy), contributing to the significant burden on the national healthcare system. Nevertheless, a lack of agreement continues among obstetric professional societies on guidelines for standardization of the approach to the diagnosis and management of patients with symptoms of preterm labor (PTL). This disparity in consensus has likely resulted in poor identification of women at an increased risk for preterm birth (PTB). This paper presents an overview of several clinical guidelines and recommendations from a variety of studies regarding the use of fetal fibronectin (fFN) testing and transvaginal ultrasound (TVU) cervical length measurement, 2 tools that are used to assess the risk of spontaneous PTB (sPTB) in women with symptoms of PTL. We identify areas of commonality and discord within these publications. Although inconsistencies exist among the published guidelines, algorithms, and studies on how to diagnose and treat women with symptoms of PTL, each of them supports the use of fFN in conjunction with TVU for assessing the risk of sPTB. In addition, we review a case study from a regional hospital system with results demonstrating the benefits to patients and process outcomes when PTL assessment protocols are standardized, incorporating both fFN and TVU test results. In the absence of consensus on this topic, healthcare providers, administrators, and payers must navigate conflicting recommendations and identify areas of agreement for this evaluation within their own local settings.

Objectives: This paper investigates back-transfer: the transfer of patients near the end of their acute hospitalization to a local community hospital for the completion of their medical care. We seek to describe factors contributing to back-transfer, with the goal of elucidating the current use of back-transfer and barriers to its more widespread adoption for rural healthcare regionalization., Study Design: Observational unmatched case-control., Methods: This was a retrospective study of adults hospitalized in Iowa between 2005 and 2013 to identify back-transferred patients. Demographic, geographic, rurality, procedural, and disease information was compared among cases and control groups using univariate analysis and multivariable logistic regression., Results: Over the 9-year period, 172,544 back-transfer eligible patients were admitted to 1 of 5 large Iowa hospitals, of which 287 (0.2%) were back-transferred. Back-transferred patients were more likely than their non-back-transferred counterparts to be older, male, and white; to live in large rural areas; and to have public insurance. As inpatients, they had longer median lengths of stay (15 vs 5 days; P <.001), more medical comorbidities, and were more likely to have a cardiac catheterization procedure than the control group., Conclusions: Back-transfer is a very rare event. While demographic and medical differences between back-transferred patients and controls may partially explain the infrequency, other systematic barriers must exist to limit back-transfer. These barriers likely include legal, financial, logistical, and patient care concerns. Despite the rarity with which it is employed, back-transfer is a promising strategy that could better utilize health resources, especially in rural America.

This supplement showcases the winning papers and case studies from the PAN Challenge, which aimed to stimulate a dialogue on ways to reduce or eliminate the barriers and disparities that Medicare and ACA enrollees face in obtaining medications to treat life-threatening, chronic, and rare diseases.

The United States' decade-long transition from a paper- to technology-based information infrastructure has always been recognized as an initial step-a laying of the foundation-for future changes to the delivery of care. An increasingly important focal area for improvement is population health. Numerous policies and programs now require healthcare organizations to manage the risks, outcomes, utilization, and health of entire groups of individuals. Nonetheless, current health information technology (IT) systems are not ready to support population health improvements effectively and efficiently. Existing health IT systems were designed for organizations that are structurally, operationally, and culturally focused on individual care delivery, rather than improving health for a population. Opportunities exist to align health IT resources and population health management strategies to fill the gaps among technological capabilities, use and the emerging demands of population health. To realize this alignment, healthcare leaders must think differently about the types of data their organizations need, the types of partners with whom they share information, and how they can leverage new information and partnerships for evidence-based action.

Objectives: As the boomer population ages, there is a growing need for integrated care organizations (ICOs) that can integrate both medical care and long-term services and supports in the home. This paper presents a policy proposal to support the creation of ICOs, redesign care, and provide financing for home- and community-based services (HCBS), with the goal of enhancing financial protection for beneficiaries, coordinating care, and preventing costly hospital and nursing home use., Methods: This study used the 2012 Medicare Current Beneficiary Survey (MCBS) Cost and Use File, inflated to 2016 figures, to describe the characteristics of Medicare beneficiaries and their healthcare utilization and spending. The costs of covering up to 20 hours of personal care services a week were estimated using MCBS population counts, participation assumptions based on the literature, and financing design parameters., Results: A targeted HCBS benefit could be added to Medicare and financed with income-related cost sharing ranging from 5% to 50%, a premium paid by Medicare beneficiaries of approximately $42 a month, and payroll taxes estimated at around 0.4% of earnings on employers and employees., Conclusions: Adoption of an HCBS benefit in Medicare would improve financial protection for beneficiaries with physical and/or cognitive impairment and provide the financing for health organizations to better integrate medical and social services. ICOs and delivery models of care emphasizing care at home would improve accessibility of care and avoid costly institutionalization; additionally, it would also reduce beneficiary reliance on Medicaid.

Objectives: This paper analyzes whether hospital participation in an accountable care organization (ACO) impacts a hospital's quality improvement and cost reduction outcomes in other value-based purchasing (VBP) programs, including the Hospital Value-Based Purchasing Program (HVBP), the Hospital Readmissions Reduction Program (HRRP), and the Hospital-Acquired Conditions (HAC) Reduction Program., Study Design: Using VBP performance data and Leavitt Partners' ACO data, 2 analyses were performed: 1) a descriptive comparison of VBP performance of hospital ACOs compared with non-ACO hospitals, and 2) a longitudinal analysis of hospitals that became part of an ACO during the second year of performance data., Methods: In the descriptive analysis, we compared VBP scores for hospital ACOs with non-ACO hospitals. To estimate the effect that becoming an ACO had on a hospital, we evaluated the performance of hospitals that became part of an ACO to all hospitals that never became part of an ACO., Results: For fiscal year 2016, hospital ACOs performed better than non-ACO hospitals for the HRRP, but not on the HVBP and the HAC Reduction Programs. Longitudinal analysis, however, reveals that results are varied, with evidence that hospitals joining ACOs did increasingly better than their peers for the HRRP, but had inconsistent results year-over-year with the HVBP., Conclusions: Despite similar goals, hospital participation in an ACO is not correlated with improved performance in all Medicare VBP programs. Organizations pursuing accountable care and also attempting to maximize Medicare VBP program performance must recognize the differences in program objectives and create strategies unique to each.

Objectives: Prior studies found that tiered provider networks channel patients to preferred providers in certain contexts. This paper evaluates whether the effects of tiered physician networks vary for different types of patients., Study Design: Cross-sectional analysis of fiscal year 2009 to 2010 administrative enrollment and claims data on nonelderly beneficiaries in Massachusetts Group Insurance Commission health plans., Methods: Main outcome measures are physician market share among new patients and the percent of physician's patients who switch away. We utilized estimated fixed effects linear regression models that were stratified by patient characteristics., Results: Physicians with the worst tier rankings had lower market share among new patients who are older and sicker, or male, representing losses in market share of 10% and 15%, respectively, than other tiered physicians. A poor tier ranking did not affect physician market share of new patients who are female or younger. There was no effect of a physician's tier ranking on the proportion of patients who switch to other doctors among any groups of patients., Conclusions: Loyalty to their own physicians is pervasive across groups of patients. Physicians with poor tier rankings lost market share among new patients who are older and sicker, and among new male patients. Together, these findings suggest that tiered network designs have the potential for the greatest impact on value in healthcare over time, as more patients seek new relationships with physicians.

This paper describes the redesign of health benefits at Covered California-the nation's largest health insurance exchange, which covers 1.3 million individuals, and its benefit designs extending to hundreds of thousands more enrollees through insurance products sold outside the exchange-with respect to specialty drugs for the 2016 enrollment year. The catalyst for benefit redesign came from advocacy organizations representing patients suffering from HIV, multiple sclerosis, epilepsy, hepatitis C, and other chronic conditions. The first component of the benefit redesign creates a separate deductible for pharmaceutical expenditures, with a commensurate reduction in the deductible for other (medical) expenditures. The second component requires health plans to assign at least 1 specialty drug for each therapeutic class to a nonspecialty tier, offering patients a treatment option for which they are not exposed to coinsurance. The third component imposes a monthly payment limit of $250 for each specialty drug prescription, thereby buffering patients using these drugs against the $6250 individual, or $13,500 family, annual medical payment limit. The pharmacy deductible and monthly out-of-pocket payment limit are substantially lower for low-income enrollees in the subsidized silver-tier products. The Covered California redesign indicates that patients can be shielded from the most onerous cost-sharing burdens while keeping premiums affordable for the entire enrolled population; however, sustainable access to care requires reductions in the underlying cost of new clinical technologies.

Objectives: Chronic diseases are common, complex, and expensive health conditions that can benefit from innovations in healthcare service delivery enabled by information technology and advanced analytic methods. This paper proposes a data-driven approach, illustrated in the context of chronic kidney disease (CKD), to develop clinical pathways of care delivery from electronic health record (EHR) data., Study Design: We analyzed structured and de-identified EHR data from 2009 to 2013 of 664 CKD patients with multiple chronic conditions., Methods: Machine learning algorithms were used to learn data-driven and practice-based clinical pathways that cluster patients into subgroups and model the co-progression of their encounter types, diagnoses, medications, and biochemical measurements. Given a pattern of biochemical measurements, our algorithm identifies the most probable clinical pathways, and makes predictions regarding future states, with and without temporal information. CKD stages, their complications, and common medications are included in the clinical pathways., Results: Using the EHR data of 664 patients who were initially in CKD stage 3 and hypertensive, we identified 7 patient subgroups-each distinguished primarily by the type of complications suffered by the patients. Our algorithm demonstrates fair accuracy (up to 44% and 75%, respectively) in learning the most probable clinical pathways and predicting future states associated with temporal patterns of biochemical measurements and patient subgroups., Conclusions: Data-driven clinical pathway learning summarizes multidimensional and longitudinal information from EHRs into clusters of common sequences of patient visits that may assist in the efficient review of current practices and identifying potential innovations in the care delivery process.

The management of metastatic melanoma has been revolutionized in recent years with the development of both targeted therapy and immunotherapy. Although potentially extending the life expectancy for patients, these therapies also significantly increase the healthcare expenditure. In this paper, we review the monthly costs for drugs approved by the FDA since 2011. Additionally, factors that affect the cost, such as dosing strategies, biomarkers, combination therapies, and political/legislative issues, will be discussed.

Objectives: To review the literature relating to treatment intensification in diabetes care and provider traits., Study Design: Literature review and synthesis., Methods: A literature search was conducted using PubMed and Google Scholar for papers published in or after 2000 that examined treatment intensification in diabetes care. Results from the searches were combined with a conventional Google search and a supplemental review of papers that were identified from reference lists of identified studies., Results: The majority of papers that were identified used administrative data to assess treatment intensification, and these showed that individuals with diabetes and elevated glucose frequently do not receive timely changes in therapy in response to hyperglycemia. Relatively few reports address provider and practice characteristics associated with these treatment decisions. Many of the studies focusing on the relationship between provider traits and treatment intensification are based on small studies in a limited number of practices. Factors such as practice size, location, or experience in treating patients with diabetes were often not addressed in the literature despite their potentially far-reaching impact on treatment., Conclusions: Our literature search on treatment intensification in diabetes care shows that the majority of papers using administrative data to assess treatment intensification suggest that care is often discordant with recommended guidelines. However, there is a dearth of literature based on large databases examining physician and practice traits related to this discordance. Better understanding physician behavior and practice traits associated with treatment intensification may permit greater targeting of interventions aimed at improving care.

Objectives: About a third of Medicare beneficiaries are covered by Medicare Advantage (MA) plans or accountable care organizations (ACOs). As a result of assuming financial risk for Medicare services and/or being eligible for shared savings, these organizations have an incentive to adopt models of delivering care that contribute to better care, improved health outcomes, and lower cost. This paper identifies innovative care models across the care continuum for high-cost Medicare beneficiaries that MA plans and ACOs could adopt to improve care while potentially achieving savings. It suggests policy changes that would accelerate testing and spread of promising care delivery model innovations., Study Design and Methods: Targeted review of the literature to identify care delivery models focused on high-cost or high-risk Medicare beneficiaries., Results: This paper presents select delivery models for high-risk Medicare beneficiaries across the care continuum that show promise of yielding better care at lower cost that could be considered for adoption by MA plans and ACOs. Common to these models are elements of the Wagner Chronic Care Model, including practice redesign to incorporate a team approach to care, the inclusion of nonmedical personnel, efforts to promote patient engagement, supporting provider education on innovations,and information systems allowing feedback of information to providers. The goal of these models is to slow the progression to long-term care, reduce health risks, and minimize adverse health impacts, all while achieving savings.These models attempt to maintain the ability of high-risk individuals to live in the home or a community-based setting, thereby avoiding costly institutional care. Identifying and implementing promising care delivery models will become increasingly important in launching successful population health initiatives., Conclusions: MA plans and ACOs stand to benefit financially from adopting care delivery models for high-risk Medicare beneficiaries that reduce hospitalization. Spreading these models to other organizations will require provider payment policy changes. Integration of acute and long-term care would further spur adoption of effective strategies for reducing or delaying entry into long-term institutional care.

Objectives: The patient-centered medical home (PCMH) model of primary care is being implemented widely, with unclear effects on healthcare utilization. How much any effect is driven by electronic health records (EHRs), a core component of PCMHs, is unknown. Our objective was to determine any association between the PCMH model and healthcare utilization and to isolate that effect from any by the EHR alone., Study Design: We conducted a prospective cohort study (2008-2010) of 275 primary care physicians and 230,593 patients in the Hudson Valley, a multi-payer region in New York state with predominantly small practices., Methods: We considered 3 groups: physicians who implemented Level III PCMHs in 2009, as per the National Committee for Quality Assurance, all of whom also used EHRs (n = 92); physicians using paper medical records (n = 119); and physicians using EHRs without the PCMH (n = 64). We used negative binomial regression to determine associations between study group and change over time for each of 7 utilization measures, adjusting for 10 physician characteristics., Results: For every 100 patients whose physicians transformed to PCMHs, there were 21 fewer specialist visits over time compared with patients whose physicians used paper records (P = .03), and 22 fewer specialist visits over time compared with patients whose physicians used EHRs without the PCMH (P = .05). There were no significant differences over time in primary care visits, radiology tests, laboratory tests, emergency department visits, admissions, or readmissions., Conclusions: The PCMH was associated with a significant decrease in the rate of specialist visits, the most expensive type of ambulatory visit, 1 year after PCMH implementation.

Objectives: Engaging specialists in accountable care organizations (ACOs) may make them more responsive to pressures to lower costs and raise quality. This paper introduces a novel accountable care design in cardiology., Study Design: Preliminary study using baseline data., Methods: The Accelerating Clinical Transformation for Creating Value and Controlling Cost in Cardiology concept study involved providers employed by the Providence Medical Group, Oregon. First, using claims data from 2009 through 2011, we created a historic budget to capture cardiovascular disease (CVD)-related costs for attributed patients on a per patient per year basis. Second, we introduced a validated quality metric, the Clinical Performance and Value vignette, to a sample of cardiology providers to examine clinical practice variation in treating coronary heart disease (CHD), coronary heart failure (CHF), and atrial fibrillation (AF). Lastly, we analyzed reimbursement claims paid for CHD, CHF, and AF, and forecasted potential cost savings from reductions in clinical variation., Results: Examining historic costs, we found they were stable over time, but variable by provider and disease. Quality scores, measured against evidence-based cardiology guidelines, ranged from 48.9% to 85.4% (mean=66.8%; SD=5.4%), and the prevalence of unnecessary testing was 46% in CHD, 71% in CHF, and 30% in AF. We project that reducing unnecessary care by 15% to 25% would yield $200,000 to $498,000 in savings ($50-$83 per patient visit) annually. And, if the top 10% of providers as determined by CVD-related costs reduced their costs by 25%, savings would be an additional $283,512 per year., Conclusions: This accountable care design framework is timely for cardiology and could be applied for other specialty conditions, such as cancer.

Electronic health records (EHRs) have potential to improve quality and safety of healthcare. However, EHR users have experienced safety concerns from EHR design and usability features that are not optimally adapted for the complex work flow of real-world practice. Few strategies exist to address unintended consequences from implementation of EHRs and other health information technologies. We propose that organizations equipped with EHRs should consider the strategy of "proactive risk assessment" of their EHR-enabled healthcare system to identify and address EHR-related safety concerns. In this paper, we describe the conceptual underpinning of an EHR-related self-assessment strategy to provide institutions a foundation upon which they could build their safety efforts. With support from the Office of the National Coordinator for Health Information Technology (ONC), we used a rigorous, iterative process to develop a set of 9 self-assessment tools to optimize the safety and safe use of EHRs. These tools, referred to as the Safety Assurance Factors for EHR Resilience (SAFER) guides, could be used to self-assess safety and effectiveness of EHR implementations, identify specific areas of vulnerability, and create solutions and culture change to mitigate risks. A variety of audiences could conduct these assessments, including frontline clinicians or care teams in different practices, or clinical, quality, or administrative leaders within larger institutions. The guides use a multifaceted systems-based approach to assess risk and empower organizations to work with internal or external stakeholders (eg, EHR developers) on optimizing EHR functionality and using EHRs to drive improvements in the quality and safety of healthcare.

Objectives: Physicians can help patients quit smoking using the 5 As of smoking cessation. This study aimed to (1) identify the proportion of known smokers that receive smoking cessation services in the course of routine clinical practice; (2) describe demographic and comorbidity characteristics of patients receiving the 5 As in these systems; and (3) evaluate differences in performance of the 5 As across health systems, gender, and age categories., Study Design: Electronic medical records of 200 current smokers from 6 unique health systems (N = 1200) were randomly selected from 2006 to 2010. Primary care encounter progress notes were hand coded for occurrences of the 5 As., Methods: Bivariate comparisons of delivery of the 3 smoking-cessation services by site, gender, and age category were analyzed using χ² tests., Results: About 50% of smokers were advised to quit smoking, 39% were assessed for their readiness to quit, and 54% received some type of assistance to help them quit smoking. Only 2% had a documented plan for follow-up regarding their quitting efforts (arrange). Significant differences were found among sites for documentation of receiving the 5 As and between age groups receiving assistance with quitting. There was no statistically significant difference between genders in receipt of the 5 As., Conclusions: Documentation of adherence to the 5 As varied by site and some demographics. Adjustments to protocols for addressing cessation and readiness to quit may be warranted. Health systems could apply the methodology described in this paper to assess their own performance, and then use that as a basis to guide improvement initiatives.

Objectives: One of the main goals of the Affordable Care Act (ACA) is to control the costs of US healthcare. Channeling patients toward more effective services is one of many approaches being used to control costs while improving health outcomes. This paper reviews value-based insurance design (VBID) concepts and discusses options for states to encourage these designs in the new health insurance exchanges (HIEs)., Methods: We reviewed the literature on VBID as well as the text of the ACA for descriptions of how VBID might be encouraged through the new state health insurance exchanges., Results: States, under healthcare reform, are allowed to promote the use of VBID designs in their exchanges. There are 4 broad approaches a state HIE could pursue with regard to VBID, ranging from establishing a process for recommending high- or low-value services and requiring plans to adhere to the recommendations, to offering no guidance to plans. The evidence surrounding how well VBID designs work is growing, but it is still limited. To date there is no evidence that reducing or eliminating copays for preventive services cuts costs in the long term. However, modeling does suggest the potential for such long-term savings,so states should proceed with caution., Conclusions: Modifying copays, even in small amounts, can send signals to patients about the relative value of drugs and services. However, long-term savings will likely result from higher copays on low-value services. The leadership of each exchange has a unique opportunity to reshape the insurance benefit landscape in its state to improve value and invest in prevention.

Increasing healthcare costs have created an emphasis on improving value, defined as how invested time, money, and resources improve health. The role of emergency departments (EDs) within value-driven health systems is still undetermined. Often questioned is the value of an ED visit for conditions that could be reasonably treated elsewhere such as office-based, urgent, and retail clinics. This paper presents a conceptual approach to assess the value of these low-acuity visits. It adapts an existing analytic model to highlight specific factors that impact key stakeholders' (patients, insurers, and society) assessments of the value of ED-based care compared with care in alternative settings. These factors are presented in 3 equations, 1 for each stakeholder, emphasizing how tangible and intangible benefits of care weigh against direct and indirect costs and how each perspective influences value. Aligning value among groups could allow stakeholders to influence each other and could guide rational change in the delivery of acute medical care for low-acuity conditions.

Objectives: A great deal of research has documented the wide variation in Medicare spending across different geographic regions in the United States. However, little research has been done on spending variation in the commercial sector. The objectives of this paper are (1) to compare variations in spending and inpatient utilization in the Blue Cross Blue Shield of Texas (BCBSTX) population and the Medicare population across 32 Texas regions and (2) to investigate if the pattern of widely varying Medicare spending but similar BCBSTX spending found in a previous analysis of El Paso and Hidalgo/McAllen exists across the state., Study Design: Retrospective study using 2008 BCBSTX and Medicare data. We used total spending per member/enrollee per month and inpatient admissions per 1000 members/enrollees., Methods: After adjusting BCBSTX and Medicare spending for price and adjusting BCBSTX spending and utilization for age and gender, we computed coefficients of variation, standard deviations from the Texas means, and kernel density estimates for standard deviations from the mean to compare variation in BCBSTX and Medicare spending and inpatient utilization., Results: Results indicated that variations across Texas in total spending and inpatient utilization are similar in BCBSTX and Medicare both in level and in direction, as the correlations between Medicare and commercial spending and inpatient utilization are positive after excluding the Hidalgo/McAllen regions., Conclusions: Over the state of Texas, regions of high Medicare spending also tend to be regions of high private insurance spending. McAllen appears to be an outlier for Medicare spending, but not for BCBSTX spending.

Diabetes affects an estimated 25.8 million US adults, or 8.3% of the population. By 2050, the prevalence of type 2 diabetes mellitus (T2DM) in the United States may be as high as 1 in 3 adults. This paper summarizes key national treatment goals, guidelines, and algorithms for T2DM management in a way that clarifies their similarities and areas of disparity, for use by managed care organizations and other healthcare professionals. In addition, the role of long-standing and newer classes of antihyperglycemic agents, including incretin-related agents, bromocriptine, and colesevelam, will be reviewed, as will emerging research on the role of lifestyle intervention in T2DM and prediabetes. Lastly, comparative and long-term clinical efficacy data on incretin therapy, reported at the American Diabetes Association's 2011 71st Scientific Sessions, will be summarized. Although the treatment landscape for T2DM has increased substantially in complexity, major guidelines have similar goals. While established, relatively inexpensive, and thoroughly investigated antihyperglycemic agents maintain popularity, incretin-based agents offer glycemic efficacy along with other benefits relative to weight loss or neutrality and low rates of hypoglycemia. In addition, the feasibility of matching patients to appropriate lifestyle intervention, for both diabetes and diabetes prevention, is increasing.

As the costs of type 2 diabetes mellitus (T2DM) care and related clinical trials continue to rise, economically viable methods are being sought to effectively predict the relative utility of various treatment options. The high price of clinical trials has led to the development of alternative methods to collect and consolidate data. Comparative effectiveness research (CER) synthesizes existing evidence to address knowledge gaps and drive patient-focused clinical decisions and outcomes. CER methods compare the health outcomes and costs associated with interventions to determine the option with the maximum patient benefit at optimal cost. In addition to traditional CER approaches such as systematic reviews, meta-analyses, and retrospective claims analyses, Markov modeling and Bayesian analysis can be applied to predict patient outcomes in scenarios where clinical trials are not feasible. Additionally, cost-benefit, cost-effectiveness, and cost-utility analyses comprise "cost-effectiveness analyses." Cost-benefit analysis looks solely at monetary value, while cost-effectiveness and cost-utility analyses include gains in health and quality of life, providing a ratio of cost to benefit. This paper will discuss a range of approaches to CER including Markov modeling, mixed treatment comparisons, the Archimedes model, and Bayesian statistics, and provide guidance in interpreting data from these studies in a managed care context, with a particular focus on evaluating treatments for T2DM. It will also provide guidance on common indices of comorbidity used in health economics research. Data from these models can be used to reduce treatment costs and improve the overall quality of population-level health.

In recent research, we explored the impact of the Medicare Part D program on hospitalization rates for ambulatory care-sensitive conditions (ACSCs) among elderly Americans.1 Our results indicate that Part D reduced a summary measure of ACSC hospitalization by 20.5 per 10,000, a percentage change of 4.1 percent. This change represents approximately 42,000 admissions, roughly half of the overall reduction in admissions in our 23-state sample during our study period (2005-2007). In this brief, we explore the state-level implications of the findings from our paper, by estimating the number of avoided hospitalizations in each state.

Objectives: To identify potentially low-value services for inclusion in value-based insurance design (VBID) programs and to discuss challenges involved in incorporating such information., Methods: We searched the Tufts Medical Center Cost-Effectiveness Analysis Registry (www.cearegistry.org) to identify examples of low-value services, defined as interventions that make health worse without saving money or those that cost at least $100,000 per quality-adjusted life-year gained. We restricted our attention to papers published since 2000. We supplemented this literature review with a list of services recently rejected by the United Kingdom's National Institute for Health and Clinical Excellence for coverage by the UK's National Health Service., Results: The list of potentially low-value services includes several drugs to treat cancer, as well as other therapies such as left ventricular assist devices and lung volume reduction surgery. Building negative incentives into VBID programs to discourage use of low-value care will involve a number of challenges, including identification of appropriate candidates; the scope of services to be covered (ie, whether VBID should be expanded beyond drugs to address medical devices, procedures, and diagnostics); and whether VBID programs should target specific subgroups., Conclusion: Identifying noncontroversial low-value services and designing VBID programs to discourage their use will not be easy. However, to fulfill their promise of improving value and moderating cost growth, VBID programs should target low-value as well as high-value care.

Objectives: To test the efficacy of an electronic asthma monitoring system (AMS) to reduce pediatric emergency department (ED) visits and hospitalizations for asthma., Study Design: Randomized clinical trial., Methods: Families of pediatric patients with asthma aged 8 to 17 years were recruited at 6 medical centers. Children were randomly assigned to the American Medical Alert Corporation pediatric AMS or a paper diary. The numbers of and costs associated with ED visits and hospitalizations for the 2 groups in the year following randomization were compared using t tests of statistical significance., Results: Of 59 children recruited to the trial, 29 were randomized to the AMS and 30 to the diary. The 2 groups were similar in demographic and clinical characteristics. During their study year, 24 AMS group members logged on a mean (SD) of 211.0 (117.3) days; 13 diary group members provided data on a mean (SD) of 136.6 (128.0) days. During the 32 months that the study was in progress, the case managers logged on a mean (SD) of 171.0 (97.2) days. Overall, 35 children had at least 1 ED visit, but only 7 children were hospitalized. The 2 groups had no statistically significant differences in the numbers of or charges associated with ED visits or hospitalizations., Conclusion: Electronic devices are being developed to make chronic disease management easier for patients and their families, but they should not be adopted without careful study, including randomized trials, to ascertain their use, costs, and benefits.

Objective: To review literature on the impact of bipolar disorder on the workplace, with respect to costs to employers, workplace productivity and functioning, and any employer-initiated programs implemented with the aim of improving work attendance and performance., Study Design: Systematic literature review., Methods: Original studies relating to bipolar disorder in the workplace were identified from PubMed and EMBASE using a reproducible, systematic search strategy in July 2007. There were no constraints on publication dates. Results were first evaluated by title and/or abstract. Full manuscripts of potentially relevant papers then were obtained and assessed for inclusion. Productivity data were extracted in terms of absenteeism, short-term disability, presenteeism, and any associated cost burden to US employers., Results: Seventeen studies met search criteria and were included in this review. The data indicate that bipolar disorder imposes a significant financial burden on employers, costing more than twice as much as depression per affected employee. A large proportion of the total cost of bipolar disorder is attributable to indirect costs from lost productivity, arising from absenteeism and presenteeism. The presence of comorbid conditions and stigma in the workplace may lead to delays in accurate diagnosis and effective management of bipolar disorder., Conclusion: Bipolar disorder among the working population can have a significant, negative effect on work relationships, attendance, and functioning, which can lead to substantial costs to US employers arising from lost productivity. There is a need for workplace initiatives to address the health and cost consequences of bipolar disorder within an employed population.

Although the literature adequately addresses the biologic basis, epidemiology, and management of breakthrough pain (BTP), it does not yet describe the full impact of this troubling, widespread phenomenon. The risks of a scanty understanding of BTP impact are failure to take preventive measures, underdiagnosis, undertreatment, and inappropriate management. Studies to date of the impact of BTP have followed pharmacoeconomic approaches. Building on prior efforts, this paper develops a more comprehensive health economic model that encompasses the full spectrum of costs, outcomes, risks and benefits associated with BTP and its management. The authors provide a rubric within which stakeholders--including providers, institutional leaders, administrators, and policymakers--can systematically balance the myriad potential effects of different treatment scenarios to guide decision-making. The paper then extends this model to the population level, providing a template for health economic analysis of alternate strategies for managing BTP, and delineating steps for accomplishing the analysis.