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High-deductible health plans (HDHPs) require substantial out-of-pocket spending for most services, although medications may be subject to traditional copayment arrangements. This study examined effects of HDHPs on medication out-of-pocket spending and use and quality of care among individuals with bipolar disorder.This quasi-experimental study used claims data (2003-2014) for a national sample of 3,532 members with bipolar disorder, ages 12-64, continuously enrolled for 1 year in a low-deductible plan (≤$500) and then for 1 year in an HDHP (≥$1,000) after an employer-mandated switch. HDHP members were matched to 18,923 contemporaneous individuals in low-deductible plans (control group). Outcome measures were out-of-pocket spending and use of bipolar disorder medications, psychotropics for other disorders, and all other medications and appropriate laboratory monitoring for psychotropics.Relative to the control group, annual out-of-pocket spending per person for bipolar disorder medications increased 20.8% among HDHP members (95% confidence interval [CI]=14.9%-26.7%), and the absolute increase was $36 (95% CI=$25.9-$45.2). Specifically, out-of-pocket spending increased for antipsychotics (27.1%; 95% CI=17.4%-36.7%) and anticonvulsants (19.2%; 95% CI=11.9%-26.6%) but remained stable for lithium (-3.7%; 95% CI=-12.2% to 4.8%). No statistically significant changes were detected in use of bipolar disorder medications, other psychotropics, or all other medications or in appropriate laboratory monitoring for bipolar disorder medications.HDHP members with bipolar disorder experienced a moderate increase in out-of-pocket spending for medications but preserved bipolar disorder medication use. Findings may reflect individuals' perceptions of the importance of these medications for their functioning and well-being.

Background: Cost-sharing disproportionately affects people with chronic illnesses needing more care. Our qualitative study examined lived experiences navigating insurance benefits and treatment for bipolar disorder, which requires ongoing access to behavioral specialists and psychotropic medications. Methods: Forty semi-structured telephone interviews with individuals with bipolar disorder and employer-sponsored health insurance, or their family caregivers, explored health care needs, coverage details, out-of-pocket (OOP) costs, and perspectives on value. An iterative analytic approach identified salient themes. Results: Most individuals in our sample faced an annual insurance deductible, from $350-$10,000. OOP costs for specialist visits ranged from $0-$450 and for monthly psychotropic medications from $0-$1650. Acute episodes and care for comorbidities, including medication side effects, added to cost burdens. Medication nonadherence due to OOP costs was rare; respondents frequently pointed to the necessity of medications: “whatever it takes to get those”; “it's a life or death situation.” Respondents also prioritized visits to psychiatrist prescribers, though visits were maximally spaced because of cost. Psychotherapy was often deemed unaffordable and forgone, despite perceived need. Interviewees cited limited networks and high out-of-network costs as barriers to specialists. Cost-sharing sometimes led to debt, skimping on nonbehavioral care or other necessities, exacerbated or prolonged mood symptoms, and stress at home. Limitations: Volunteer respondents may not fully represent the target population. Conclusions: Many people with bipolar disorder in US employer-sponsored plans experience undertreatment, hardship, and adverse health consequences due to high cost-sharing. More nuanced insurance benefit designs should accommodate the needs of individuals with complex conditions.

Objectives To determine the impact of high-deductible health plans (HDHPs) on health care use among individuals with bipolar disorder. Study design Interrupted time series with propensity score-matched control group design, using a national health insurer's claims data set with medical, pharmacy, and enrollment data. Methods The intervention group was composed of 2862 members with bipolar disorder who were enrolled for 1 year in a low-deductible (≤$500) plan and then 1 year in an HDHP (≥$1000) after an employer-mandated switch. HDHP members were propensity score matched 1:3 to contemporaneous controls in low-deductible plans. The main outcomes included out-of-pocket spending per health care service, mental health-related outpatient visits (subclassified as visits to nonpsychiatrist mental health providers and to psychiatrists), emergency department (ED) visits, and hospitalizations. Results Mean pre- to post-index date out-of-pocket spending per visit on all mental health office visits, nonpsychiatrist mental health provider visits, and psychiatrist visits increased by 21.9% (95% CI, 15.1%-28.6%), 33.8% (95% CI, 2.0%-65.5%), and 17.8% (95% CI, 12.2%-23.4%), respectively, among HDHP vs control members. The HDHP group experienced a -4.6% (95% CI, -11.7% to 2.5%) pre- to post change in mental health outpatient visits relative to controls, a -10.9% (95% CI, -20.6% to -1.3%) reduction in nonpsychiatrist mental health provider visits, and unchanged psychiatrist visits. ED visits and hospitalizations were also unchanged. Conclusions After a mandated switch to HDHPs, members with bipolar disorder experienced an 11% decline in visits to nonpsychiatrist mental health providers but unchanged psychiatrist visits, ED visits, and hospitalizations. HDHPs do not appear to have a "blunt instrument" effect on health care use in bipolar disorder; rather, patients might make trade-offs to preserve important care.

BACKGROUND High deductible health plans linked to Health Savings Accounts (HSA-HDHPs) must include all care under the deductible except for select preventive services. Some employers and insurers have adopted Preventive Drug Lists (PDLs) that exempt specific classes of medications from deductibles. OBJECTIVE The objective of this study was to examine the association between shifts to PDL coverage and medication utilization among patients with diabetes in HSA-HDHPs. RESEARCH DESIGN A natural experiment comparing pre-post changes in monthly and annual outcomes in matched study groups. SUBJECTS The intervention group included 1744 commercially-insured HSA-HDHP patients with diabetes age 12-64 years switched by employers to PDL coverage; the control group included 3349 propensity-matched HSA-HDHP patients whose employers offered no PDL. MEASURES Outcomes were out-of-pocket (OOP) costs for medications and the number of pharmacy fills converted to 30-day equivalents. RESULTS Transition to the PDL was associated with a relative pre-post decrease of $612 (-35%, P

The effects of high-deductible health plans (HDHPs) on breast cancer diagnosis and treatment among vulnerable populations are unknown. We examined time to first breast cancer diagnostic testing, diagnosis, and chemotherapy among a group of women whose employers switched their insurance coverage from health plans with low deductibles ($500 or less) to plans with high deductibles ($1,000 or more) between 2004 and 2014. Primary subgroups of interest comprised 54,403 low-income and 76,776 high-income women continuously enrolled in low-deductible plans for a year and then up to four years in HDHPs. Matched controls had contemporaneous low-deductible enrollment. Low-income women in HDHPs experienced relative delays of 1.6 months to first breast imaging, 2.7 months to first biopsy, 6.6 months to incident early-stage breast cancer diagnosis, and 8.7 months to first chemotherapy. High-income HDHP members had shorter delays that did not differ significantly from those of their low-income counterparts. HDHP members living in metropolitan, nonmetropolitan, predominantly white, and predominantly nonwhite areas also experienced delayed breast cancer care. Policies may be needed to reduce out-of-pocket spending obligations for breast cancer care.

BACKGROUND: Unaffordability of medications is a barrier to effective treatment. Cost-related nonadherence (CRN) is a crucial, widely used measure of medications access. OBJECTIVES: Our study examines the current national prevalence of and risk factors for CRN (e.g., not filling, skipping or reducing doses) and companion measures in the US Medicare population. RESEARCH DESIGN: Survey-weighted analyses included logistic regression and trends 2006–2016. SUBJECTS: Main analyses used the 2016 Medicare Current Beneficiary Survey. Our study sample of 12,625 represented 56 million community-dwelling beneficiaries. MEASURES: Additional outcome measures were spending less on other necessities in order to pay for medicines and use of drug cost reduction strategies such as requesting generics. RESULTS: In 2016, 34.5% of enrollees under 65 years with disability and 14.4% of those 65 years and older did not take their medications as prescribed due to high costs; 19.4% and 4.7%, respectively, experienced going without other essentials to pay for medicines. Near-poor older beneficiaries with incomes $15–25K had 50% higher odds of CRN (vs >$50K), but beneficiaries with incomes

In an attempt to improve diabetes outcomes, some employers and insurers have adopted Preventive Drug Lists (PDLs) that reduce out-of-pocket costs for antidiabetic and cardioprotective medications to $0. We sought to determine whether shifts to PDL coverage reduce acute diabetes complications and high-acuity outcomes among commercially insured patients with diabetes. Our study design was a natural experiment comparing changes in outcomes 1 year before and after the PDL switch in matched study groups. The Intervention group included 16,174 commercially-insured diabetes patients age 12-64 switched by their employers to PDL coverage; the Control group included 711,085 coarsened exact-matched contemporaneous patients whose employers offered no PDL. We conducted similar analyses in a subset of low-income members switched to PDL plans and their matched controls. Outcomes were acute diabetes complication visits, high-severity emergency department visits, and hospitalization days. Transition to the PDL was associated with a relative pre-post change of 1.6% (95% confidence interval, -7.2% to 10.3%) in acute diabetes complication visits, -3.2% (-14.4% to 8.1%) in high-severity emergency department visits, and 2.2% (-9.8% to 14.1%) in hospitalization days. Findings were similar in the low-income subgroup. We did not find detectable changes in acute diabetes complication visits and high-acuity outcomes among diabetes patients switched to low drug cost sharing health plans. Further research should assess longer-term outcomes and examine effects of reducing financial barriers to outpatient and emergency department care. Disclosure J. Wharam: None. M. Lakoma: None. F. Zhang: None. J. Wallace: None. L.F. Garabedian: None. S.B. Soumerai: None. D. Ross-Degnan: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases; Centers for Disease Control and Prevention (5U18DP006122-05)

Purpose Understanding bicycle-vehicle collisions that result in hit-and-run (HAR) behavior is an important concern for multiple disciplines, such as public health, transportation safety, enforcement, and affected individuals. If bicyclists are injured, this issue has implications for expedient access to medical care and for protection from the financial burden of associated injury and property costs. This study aimed to identify significant predictors of vehicle-bicycle HARs, the results of which help inform interdisciplinary prevention interventions. Method Data were collected from Boston Police Department bicycle collision reports for 2009–2012. The data identified whether a collision was a HAR and other predictor variables including road and bicyclist characteristics. The probability of a HAR was fit to selected variables through logistic regression models. Effects of the predictors were reported as odds ratios. Results Police reported data from Boston, Massachusetts were examined for the years 2009 to 2012. Of the 1646 bike-vehicle collisions, 6% (n=93) resulted in a HAR and 80% (n=1309) involved an injury to the bicyclist. Controlling for all other variables, the odds of a HAR did not differ when the bicyclist was injured versus not injured or male versus female. The odds of a HAR were 2.40 (95% CI: 1.31, 4.23) times more likely when the vehicle was a taxi versus another type of vehicle, 1.65 (95% CI: 1.08, 2.54) times more likely during night as during daylight hours, and 1.74 (95%: 1.07, 2.66) times more likely during the weekend versus during the week. The interactions of male-by-injured, taxi-by-injured, and night-by-weekend were nonsignificant. Conclusion The probability of a HAR partially depends on time, day of the week, and whether the vehicle type was a taxi. We discuss implications for policies and interventions aimed at preventing this type of collision and crime.

RESEARCH OBJECTIVE: Older adults and disabled individuals in Medicare often have limited financial resources and high levels of health care needs. When out‐of‐pocket costs are not affordable, treatment may be delayed or forgone, potentially leading to worse health outcomes. We examined newly available survey data to produce the first national prevalence estimates of problems paying medical bills and delaying care due to costs among Medicare enrollees. STUDY DESIGN: The Medicare Current Beneficiary Survey (MCBS) has enhanced the measurement of health care affordability with new questionnaire items. These include whether enrollees experienced problems paying or were unable to pay any medical bills in the past year, and, if so, whether they currently have medical bills that are being paid off over time and whether they have been contacted by a collection agency in the last year due to problems paying. A separate MCBS question asks whether enrollees have delayed seeking medical care in the past year because of cost worries. Our survey‐weighted analyses estimated the prevalence of payment problems and cost‐related delays among the overall Medicare population and groups defined by demographic and health‐related factors. We further tested predictors using multivariate logistic regression. POPULATION STUDIED: We included community‐dwelling participants in the nationally representative 2017 MCBS: 10,974 older adults aged 65+ years and 2197 adults aged 18‐64 years with long‐term disability status, together representing 53.0 million Medicare enrollees. PRINCIPAL FINDINGS: Overall, the prevalence of problems paying medical bills was 7.4% among older enrollees and 29.8% among disabled enrollees. Among seniors who had problems paying, 48.2% were paying off bills over time, and 44.3% had been contacted by a collection agency; these proportions were higher for disabled individuals (50.5% and 62.2%, respectively). Delayed care due to costs was similarly common (8.3% among those ≥65, 25.2% among

Objective To examine changes in children's albuterol use and out-of-pocket (OOP) costs in response to increased copayments after the Food and Drug Administration banned inhalers with chlorofluorocarbon (CFC) propellants. Setting Four health maintenance organizations (HMOs), two that increased copayments for albuterol inhalers that went from generic CFC-containing to branded CFC-free versions, and two that retained generic copayments for CFC-free inhalers (controls). We included children with asthma aged 4–17 years with commercial coverage from 2007 to 2010. Design Interrupted time series with comparison series. Data We obtained enrollee and plan characteristics from enrollment files, and utilization data from pharmacy and medical claims; OOP expenditures were extracted from pharmacy claims for two HMOs with cost data available. Findings There were no significant differences in albuterol use between the group with increased cost-sharing and controls with respect to changes after the policy change. There was a postpolicy increase of $6.11 OOP per month per child using albuterol among those with increased cost-sharing versus $0.36 in controls; the difference between groups was significant (p

Background The transition from Medicaid-only to dual Medicare/Medicaid coverage has the potential to reduce financial barriers to health care for patients with serious mental illness through increased coverage or expanded access to clinicians as their reimbursement increases. Aims To estimate the effect of dual coverage after Medicaid enrollment during the required waiting period among adults with serious mental illness on health care use, overall and related to mental health and substance use disorders (MHSUD). Methods Data include enrollment and claims from Medicaid and Medicare in Missouri and South Carolina, from January 2004 to December 2007. We used an interrupted time-series design to estimate the effect of dual coverage on average use of outpatient, emergency department (ED), and inpatient care/month. Results After 12 months of dual coverage, the probability of outpatient care use increased in both states from 4% to 9%. In Missouri, the mean probability and frequency of ED visits, total and MHSUD related, increased by 21%-32%; the probability of all-cause and MHSUD-related inpatient admissions increased by 10% and 19%, respectively. In South Carolina, the mean probability of any inpatient admission increased by 27% and of any MHSUD-related inpatient admission by 42%. Discussion The increase in use of outpatient care is consistent with the expected increase in coverage of, and payment for, outpatient services under dual coverage relative to Medicaid-only. Sustained increases in ED and inpatient admissions raise questions regarding the complexity of obtaining care under 2 programs, pent-up demand among beneficiaries pretransition, and the complementarity of outpatient and inpatient service use.

Objective To evaluate the impact of the 2006 Massachusetts health reform, the model for the Affordable Care Act, on short-term enrollment and utilization in the unsubsidized individual health insurance market. Data Source Seven years of administrative and claims data from Harvard Pilgrim Health Care. Research Design We employed pre-post survival analysis and an interrupted time series design to examine changes in enrollment length, utilization patterns, and use of elective procedures (discretionary inpatient surgeries and infertility treatment) among nonelderly adult enrollees before (n = 6,912) and after (n = 29,207) the MA reform. Principal Findings The probability of short-term enrollment dropped immediately after the reform. Rates of inpatient encounters (HR = 0.83, 95 percent CI: 0.74, 0.93), emergency department encounters (HR = 0.85, 95 percent CI: 0.80, 0.91), and discretionary inpatient surgeries (HR = 0.66 95 percent CI: 0.45, 0.97) were lower in the postreform period, whereas the rate of ambulatory visits was somewhat higher (HR = 1.04, 95 percent CI: 1.00, 1.07). The rate of infertility treatment was higher after the reform (HR = 1.61, 95 percent CI: 1.33, 1.97), driven by women in individual (vs. family) plans. The reform was not associated with increased utilization among short-term enrollees. Conclusions MA health reform was associated with a decrease in short-term enrollment and changes in utilization patterns indicative of reduced adverse selection in the unsubsidized individual market. Adverse selection may be a problem for specific, high-cost treatments.

This analysis of survey data presents national estimates of food insecurity prevalence within the Medicare population.

Background: Diabetes is a major cause of morbidity and mortality and a driver of escalating health care costs in the U.S. In attempts to reduce costs, U.S. employers are increasingly offering consumer-directed health plans (CDHPs) that include Health Savings Accounts (HSA) or Health Reimbursement Arrangements (HRA) and high annual deductibles. Recent research has found that CDHPs are associated with concerning impacts on diabetes patients, but growth in CDHP enrollment and their out-of-pocket (OOP) cost trends in this vulnerable population are unknown. Methods: We used a time series design to assess 2005-2014 annual trends among ∼70 million unique members of all ages insured by a large national commercial insurer from 2005-2014. We analyzed mutually exclusive populations of interest, identified by ACG, comprising: (1) diabetes mellitus with no cardiovascular disease (DM), (2) diabetes with co-morbid cardiovascular disease (DM+CVD), and (3) “healthy” (i.e., ACG score Results: CDHP prevalence among DM members increased by 2.5% per year (p Conclusions: CDHP enrollment has increased markedly over the last 10 years among members with and without diabetes. However, diabetes members were less likely than healthier members to be in CDHPs, particularly if they had co-morbid CVD. Among diabetes patients, OOP costs were significantly higher for CDHP than non-CDHP members. Disclosure L.F. Garabedian: Other Relationship; Self; Harvard Pilgrim Health Care. D. Ross-Degnan: None. F. Zhang: None. M.X. Callahan: None. R. LeCates: None. J. Wallace: None. S.B. Soumerai: None. J.F. Wharam: None.

Purpose High-deductible health plans (HDHPs) require substantial out-of-pocket spending and might delay crucial health services. Breast cancer treatment delays of as little as 2 months are associated with adverse outcomes. Methods We used a controlled prepost design with survival analysis to assess timing of breast cancer care events among 273,499 women age 25 to 64 years without evidence of breast cancer before inclusion. Women were included if continuously enrolled for 1 year in a low-deductible ($0 to $500) plan followed by up to 4 years in a HDHP (at least $1,000 deductible) after an employer-mandated switch. Study inclusion was on a rolling basis, and members were followed between 2003 and 2012. The comparison group comprised 2.4 million contemporaneously matched women whose employers offered only low-deductible plans. Measures were times to first diagnostic breast imaging (diagnostic mammogram, breast ultrasound, or breast magnetic resonance imaging), breast biopsy, incident early-stage breast cancer diagnosis, and breast cancer chemotherapy. Outcomes were analyzed by using Cox models and adjusted for age-group, morbidity score, poverty level, US region, index date, and employer size. Results After the index date, HDHP members experienced delays in receipt of diagnostic imaging (adjusted hazard ratio [aHR], 0.95; 95% CI, 0.94 to 0.96), biopsy (aHR, 0.92; 95% CI, 0.89 to 0.95), early-stage breast cancer diagnosis (aHR, 0.83; 0.78 to 0.90), and chemotherapy initiation (aHR, 0.79; 95% CI, 0.72 to 0.86) compared with the control group. Conclusion Women switched to HDHPs experienced delays in diagnostic breast imaging, breast biopsy, early-stage breast cancer diagnosis, and chemotherapy initiation. Additional research should determine whether such delays cause adverse health outcomes, and policymakers should consider selectively reducing out-of-pocket costs for key breast cancer services.

Objective:The study sought to determine the impact of a pediatric behavioral health screening and colocation model on utilization of behavioral health care.Methods:In 2003, Cambridge Health Alliance, a Massachusetts public health system, introduced behavioral health screening and colocation of social workers sequentially within its pediatric practices. An interrupted time-series study was conducted to determine the impact on behavioral health care utilization in the 30 months after model implementation compared with the 18 months prior. Specifically, the change in trends of ambulatory, emergency, and inpatient behavioral health utilization was examined. Utilization data for 11,223 children ages ≥4 years 9 months to

The broader implications of the Medicare prescription drug insurance benefit (Part D) are of national importance because the benefit substantially increased access to prescription drugs for more than 47 million older adults and adults with disabilities (1). Since its implementation in 2006, Part D has become so widespread that even patient groups who previously had drug coverage substantially increased their medication use (1); nonadherence related to difficulties in paying for medication also declined (2, 3). Medication use can influence health; however, little is known about the role of Part D in improving the health of the Medicare population, reducing the need for other medical services, or changing the efficiency of care. Several studies have detected encouraging reductions in spending on nondrug medical services after Part D implementation, but all used data from the early transition years (2006 to 2007) and were limited by a focus on population subgroups, particularly those who voluntarily enrolled to obtain drug coverage or more generous coverage (4). These self-selected enrollees were likely to differ from other subgroups in unmeasured ways and to be better prepared to take advantage of their new coverage. Their experience with Part D is probably more striking than that of the entire Medicare population on average. Medicare beneficiaries with limited or no drug benefits before 2006 saw statistically significant decreases in nondrug medical spending after enrolling in Part D (5, 6). Medicare hospitalizations decreased after Part D implementation in states where preimplementation drug coverage rates had been especially low (7). These associations in selected subgroups may not be generalizable to the larger Medicare population, however, because most of the population previously had drug coverage (8). Nevertheless, the U.S. Congressional Budget Office, partially in response to the subgroup evaluations, recently adopted a new costing method that assumes that increases in prescription fills at the full population level offset overall costs in other Medicare services (9). To address the lack of information about possible population-wide cost offsets associated with Part D, we estimated changes in health outcomes and medical services across the entire community-dwelling Medicare population to determine its comprehensive long-term policy effects. We used 11 years of survey data from the Medicare Current Beneficiary Survey (MCBS) (2000 to 2010 [latest data available]). To our knowledge, this is the only data set with nationally representative information on the health, functioning, and health service use of both the fee-for-service and Medicare Advantage populations. Medicare Advantage enrollees are a large and growing segment of the Medicare population, and they are missing in Medicare claims-based evaluations. We used a longitudinal study design with strong external validity for assessing the national implications of Part D (8). We hypothesized that, in the absence of Part D, population-level trends in health and medical services would have followed previously established trends; any statistically significant and consistent change in those trends after 2006 may be attributable to Part D.

The high prevalence and costs of type 2 diabetes makes it a rapidly evolving focus of policy action. Health systems, employers, community organizations, and public agencies have increasingly looked to translate the benefits of promising research interventions into innovative policies intended to prevent or control diabetes. Though guided by research, these health policies provide no guarantee of effectiveness and may have opportunity costs or unintended consequences. Natural experiments use pragmatic and available data sources to compare specific policies to other policy alternatives or predictions of what would likely have happened in the absence of any intervention. The Natural Experiments for Translation in Diabetes (NEXT-D) Study is a network of academic, community, industry, and policy partners, collaborating to advance the methods and practice of natural experimental research, with a shared aim of identifying and prioritizing the best policies to prevent and control diabetes. This manuscript describes the NEXT-D Study group's multi-sector natural experiments in areas of diabetes prevention or control as case examples to illustrate the selection, design, analysis, and challenges inherent to natural experimental study approaches to inform development or evaluation of health policies.

Purpose In November 2009, the US Preventive Services Task Force (USPSTF) changed its mammography recommendations from every 1 to 2 years among women age ≥ 40 years to personalized screening decisions for women age 40 to 49 years and screening every 2 years for women age 50 to 74 years. Methods We studied mammography trends among 5.5 million women age 40 to 64 years enrolled in a large national health insurer. We used 2005 to 2009 mammography trends to predict 2012 rates. Our primary measure was the estimated difference between observed and predicted 2012 annual and biennial mammography rates. We stratified results by age group and race/ethnicity. Results Among women age 40 to 49 years, 2012 mammography rates declined by 9.9% (95% CI, −10.4% to −9.3%) relative to the predicted 2012 rate. Decreases were lowest among black women (−2.3%; 95% CI, −6.3% to 1.8%) and highest among Asian women (−17.4; 95% CI, −20.0 to −14.8). Annual mammography rates among women age 50 to 64 years declined by 6.1% (95% CI, −6.5% to −5.7%) by 2012. Regarding biennial mammography rates, women age 40 to 49 years experienced a 9.0% relative reduction (95% CI, −9.6% to −8.4%). White, Hispanic, and Asian women age 40 to 49 years demonstrated similar relative reductions of approximately 9% to 11%, whereas black women had no detectable changes (0.1%; 95% CI, −4.0% to 4.3%). Women age 50 to 64 years had a 6.2% relative reduction (95% CI, −6.6% to −5.7%) in biennial mammography that was similar among white, Hispanic, and Asian women. Black women age 50 to 64 years did not have changes in biennial mammography (0.4%; 95% CI, −2.6% to 3.5%). Conclusion Three years after publication of the 2009 USPSTF guidelines, mammography rates declined by 6% to 17% among white, Hispanic, and Asian women but not among black women. Small reductions in biennial mammography might be an unintended consequence of the updated guidelines.

BACKGROUNDPolicymakers may wish to align healthcare payment and quality of care while minimizing unintended consequences, particularly for safety net hospitals.OBJECTIVETo determine whether the 2008 Centers for Medicare and Medicaid Services Hospital-Acquired Conditions policy had a differential impact on targeted healthcare-associated infection rates in safety net compared with non–safety net hospitals.DESIGNInterrupted time-series design.SETTING AND PARTICIPANTSNonfederal acute care hospitals that reported central line–associated bloodstream infection and ventilator-associated pneumonia rates to the Centers for Disease Control and Prevention’s National Health Safety Network from July 1, 2007, through December 31, 2013.RESULTSWe did not observe changes in the slope of targeted infection rates in the postpolicy period compared with the prepolicy period for either safety net (postpolicy vs prepolicy ratio, 0.96 [95% CI, 0.84–1.09]) or non–safety net (0.99 [0.90–1.10]) hospitals. Controlling for prepolicy secular trends, we did not detect differences in an immediate change at the time of the policy between safety net and non–safety net hospitals (P for 2-way interaction, .87).CONCLUSIONSThe Centers for Medicare and Medicaid Services Hospital-Acquired Conditions policy did not have an impact, either positive or negative, on already declining rates of central line–associated bloodstream infection in safety net or non–safety net hospitals. Continued evaluations of the broad impact of payment policies on safety net hospitals will remain important as the use of financial incentives and penalties continues to expand in the United States.Infect Control Hosp Epidemiol 2015;00(0): 1–7

Black patients with diabetes are at greater risk of underuse of antidepressants even when they have equal access to health insurance. This study aimed to evaluate the impact of removing a significant financial barrier to prescription medications (drug caps) on existing black-white disparities in antidepressant treatment rates among patients with diabetes and comorbid depression.We used an interrupted time series with comparison series design and a 5% representative sample of all fee-for-service Medicare and Medicaid dual enrollees to evaluate the removal of drug caps on monthly antidepressant treatment rates. We evaluated the impact of drug cap removal on racial gaps in treatment by modeling the month-to-month white-black difference in use within age strata (younger than 65 years of age or 65 years of age or older). We compared adult dual enrollees with diabetes and comorbid depression living in states with strict drug caps (n = 221) and those without drug caps (n = 1133) before the policy change. Our primary outcome measures were the proportion of patients with any antidepressant use per month and the mean standardized monthly doses (SMDs) of antidepressants per month.The removal of drug caps in strict drug cap states was associated with a sudden increase in the proportion of patients treated for depression (4 percentage points; 95% CI, 0.03-0.05, P0.0001) and in the intensity of antidepressant use (SMD: 0.05; 95% CI, 0.03-0.07, P0.001). Although antidepressant treatment rates increased for both white and black patients, the white-black treatment gap increased immediately after Part D (0.04 percentage points; 95% CI, 0.01-0.08) and grew over time (0.04 percentage points per month; 95% CI, 0.002-0.01; P0.001).Policies that remove financial barriers to medications may increase depression treatment rates among patients with diabetes overall while exacerbating treatment disparities. Tailored outreach may be needed to address nonfinancial barriers to mental health services use among black patients with diabetes.

Background In 2011, Manitoba implemented a province-wide program of physician detailing and free sampling for generic atorvastatin to increase use of this generic statin. We examined the impact of this unique combined program of detailing and sampling for generic atorvastatin on the use and cost of statin medicines, market share of generic atorvastatin, the choice of starting statin for new users, and switching from a branded statin to generic atorvastatin. Methods We conducted a retrospective study of Manitoba insurance claims data for all continuously enrolled patients who filled one or more prescriptions for a statin between 2008 and 2013. Data were linked to physician-level data on the number of detailing visits and sample provision. We used interrupted time series analyses to assess policy-related changes in the use and cost of statin medicines, market share of generic atorvastatin, the choice of starting statin for new users, and switching from a branded statin to generic atorvastatin. Results The detailing program reached 31% (651/2103) of physicians who prescribed a statin during the study period. Collectively, these physicians prescribed 61% of statins dispensed in the province. Free sample cards were provided to 61% (394/651) of the detailed physicians. The program did not change the level or trend in the overall statin use rate and the total cost of statins or increase the number of patients switching from another branded statin to generic atorvastatin. We found the program had a small impact on atorvastatin’s market share of new prescriptions, with a level increase of 2.6%. Conclusions Though physician detailers were skilled at targeting high-prescribing physicians, a combined program of detailing visits and sample provision for generic atorvastatin did not lower overall statin costs or lead to switching from branded statins to the generic. The preceding introduction of generic atorvastatin appeared sufficient to modify prescribing patterns and decrease costs.

Objectives To evaluate the impact of transitioning from Medicaid to Medicare Part D drug coverage on the use of noncancer treatments among dual enrollees with cancer. Methods We leveraged a representative 5% national sample of all fee-for-service dual enrollees in the United States (2004–2007) to evaluate the impact of the removal of caps on the number of reimbursable prescriptions per month (drug caps) under Part D on 1) prevalence and 2) average days' supply dispensed for antidepressants, antihypertensives, and lipid-lowering agents overall and by race (white and black). Results The removal of drug caps was associated with increased use of lipid-lowering medications (days' supply 3.63; 95% confidence interval [CI] 1.57–5.70). Among blacks in capped states, we observed increased use of lipid-lowering therapy (any use 0.08 percentage points; 95% CI 0.05–0.10; and days' supply 4.01; 95% CI 2.92–5.09) and antidepressants (days' supply 2.20; 95% CI 0.61–3.78) and increasing trends in antihypertensive use (any use 0.01 percentage points; 95% CI 0.004–0.01; and days' supply 1.83; 95% CI 1.25–2.41). The white-black gap in the use of lipid-lowering medications was immediately reduced (−0.09 percentage points; 95% CI −0.15 to −0.04). We also observed a reversal in trends toward widening white-black differences in antihypertensive use (level −0.08 percentage points; 95% CI −0.12 to −0.05; and trend −0.01 percentage points; 95% CI −0.02 to −0.01) and antidepressant use (−0.004 percentage points; 95% CI −0.01 to −0.0004). Conclusions Our findings suggest that the removal of drug caps under Part D had a modest impact on the treatment of hypercholesterolemia overall and may have reduced white-black gaps in the use of lipid-lowering and antidepressant therapies.

OBJECTIVE High-deductible health plans (HDHPs) are now the predominant commercial health insurance benefit in the U.S. We sought to determine the effects of HDHPs on emergency department and hospital care, adverse outcomes, and total health care expenditures among patients with diabetes. RESEARCH DESIGN AND METHODS We applied a controlled interrupted time–series design to study 23,493 HDHP members with diabetes, aged 12–64, insured through a large national health insurer from 2003 to 2012. HDHP members were enrolled for 1 year in a low-deductible (≤$500) plan, followed by 1 year in an HDHP (≥$1,000 deductible) after an employer-mandated switch. Patients transitioning to HDHPs were matched to 192,842 contemporaneous patients whose employers offered only low-deductible coverage. HDHP members from low-income neighborhoods ( n = 8,453) were a subgroup of interest. Utilization measures included emergency department visits, hospitalizations, and total (health plan plus member out-of-pocket) health care expenditures. Proxy health outcome measures comprised high-severity emergency department visit expenditures and high-severity hospitalization days. RESULTS After the HDHP transition, emergency department visits declined by 4.0% (95% CI −7.8, −0.1), hospitalizations fell by 5.6% (−10.8, −0.5), direct (nonemergency department–based) hospitalizations declined by 11.1% (−16.6, −5.6), and total health care expenditures dropped by 3.8% (−4.3, −3.4). Adverse outcomes did not change in the overall HDHP cohort, but members from low-income neighborhoods experienced 23.5% higher (18.3, 28.7) high-severity emergency department visit expenditures and 27.4% higher (15.5, 39.2) high-severity hospitalization days. CONCLUSIONS After an HDHP switch, direct hospitalizations declined by 11.1% among patients with diabetes, likely driving 3.8% lower total health care expenditures. Proxy adverse outcomes were unchanged in the overall HDHP population with diabetes, but members from low-income neighborhoods experienced large, concerning increases in high-severity emergency department visit expenditures and hospitalization days.

ObjectiveIn January 2006 insurance coverage for medications shifted from Medicaid to Medicare Part D private drug plans for the six million individuals enrolled in both programs. Dual beneficiaries faced new formularies and utilization management policies. It is unclear whether Part D, compared with Medicaid, relaxed or tightened psychiatric medication management, which could affect receipt of recommended pharmacotherapy, and emergency department use related to treatment discontinuities. This study examined the impact of the transition from Medicaid to Part D on guideline-concordant pharmacotherapy for bipolar I disorder and emergency department use.MethodsUsing interrupted–time-series analysis and Medicaid and Medicare administrative data from 2004 to 2007, the authors analyzed the effect of the coverage transition on receipt of guideline-concordant antimanic medication, guideline-discordant antidepressant monotherapy, and emergency department visits for a nationally representative continuous cohort of 1...

Background.The Centers for Medicare and Medicaid Services (CMS) implemented a policy in October 2008 to eliminate additional Medicare payment for mediastinitis following coronary artery bypass graft (CABG) surgery.Objective.To evaluate the impact of this policy on mediastinitis rates, using Medicare claims and National Healthcare Safety Network (NHSN) prospective surveillance data.Methods.We used an interrupted time series design to compare mediastinitis rates before and after the policy, adjusted for secular trends. Billing rates came from Medicare inpatient claims following 638,761 CABG procedures in 1,234 US hospitals (January 2006-September 2010). Prospective surveillance rates came from 151 NHSN hospitals in 29 states performing 94,739 CABG procedures (January 2007-September 2010). Logistic regression mixed-effects models estimated trends for mediastinitis rates.Results.We found a sudden drop in coding for index admission mediastinitis at the time of policy implementation (odds ratio, 0.36 [95% confidence interval (CI), 0.23-0.57]) and a decreasing trend in coding for index admission mediastinitis in the postintervention period compared with the preintervention period (ratio of slopes, 0.83 [95% CI, 0.74-0.95]). However, we saw no impact of the policy on infection rates as measured using NHSN data. Our results were not affected by changes in patient risk over time, heterogeneity in hospital demographics, or timing of hospital participation in NHSN.Conclusions.The CMS policy of withholding additional Medicare payment for mediastinitis on the basis of claims-based evidence of infection was associated with changes in coding for infections but not with changes in actual infection rates during the first 2 years after policy implementation.

120 Background: High-deductible health plans (HDHP) are associated with breast cancer treatment delays of up to 10 months, but their impact on health outcomes is unknown. We hypothesized that, compared with women in generous plans, HDHP members would present with more advanced disease and thus experience higher total costs of early care. Methods: We studied 2004-2014 claims data from a large US health insurer. We included women aged 25-64 who were in traditional low-deductible (≤$500) health plans for 1 baseline year then experienced either an employer-mandated switch to HDHPs (≥$1000) for up to 4 or years or an employer-mandated continuation in low deductible plans. We defined the HDHP switch date as the index date. We then restricted to women who developed incident breast cancer after the index date. Using baseline characteristics, we closely matched HDHP members with incident breast cancer to contemporaneous women with incident breast cancer who remained in low-deductible plans. We measured total costs of all health care services in the 60 days after incident breast cancer diagnosis as a proxy for the intensity of incident breast cancer care. We used negative binomial regression adjusted for baseline characteristics to compare total 60-day costs among HDHP and control members. We also subset analyses to low-income women. Results: We included 1514 HDHP members and 9283 matched controls. 60-day costs after incident breast cancer diagnosis were $24,151 (95% CI: $22,766, $25,535) among HDHP members and $22,474 ($21,952, $22,996) among controls, an absolute difference of $1677 ($197, $3156) and a relative difference of 7.5% (8.1%, 14.1%). Low-income HDHP members had corresponding absolute and relative differences of $2653 ($368, $4939) and 12.5% (1.5%, 23.5). Conclusions: HDHP members with incident breast cancer had 7.5% higher health care costs in the 60 days after incident breast cancer than women with more generous coverage, a finding driven 12.5% higher costs among low-income HDHP members. Results raise concerns that delays in breast cancer care among HDHP members are associated with more advanced disease and adverse outcomes.

Background:The loss of functional hand skills is a primary characteristic of Rett syndrome. Stereotypies, dyspraxia, and other sensory processing issues severely limit the individual’s ability to reach toward and sustain grasp on objects. This loss of functional reach and grasp severely limits their ability to participate in self-help, play, and school-related activities. We proposed that Ayres Sensory Integration (ASI) treatment would improve sensory processing and motor planning, which would lay the sensory-motor groundwork for improving grasp of objects, an important first step in developing functional hand use.Objective:We examined effects of ASI treatment on rate of reaching and grasping for children with Rett syndrome/Rett-related disorders.Methods:We used an interrupted time series design to measure changes in outcome variables occurring after intervention initiation and cessation. We analyzed daily video observations during baseline, intervention, and post-intervention periods, over a span of 7 months.Results:During baseline, rate of grasping declined moderately. There was a 15% increase in grasping from the end of baseline to end of the post-intervention period. There was no significant change in rate of reaching.Conclusions:This study provides preliminary data showing very small improvements in hand grasp of children with Rett syndrome following ASI treatment; larger studies in diverse settings are needed to establish the effectiveness of this approach. This study shows that an interrupted time series research design provides a valid template for evaluating interventions for children with rare disorders.

Study objective The objective of this study was to evaluate the relationship between self-reported cost-related nonadherence to prescription medications and emergency department (ED) utilization among Medicare beneficiaries. We hypothesized that persons who report cost-related medication nonadherence would have subsequent higher ED use. Methods We conducted a retrospective cohort study of continuously enrolled Medicare beneficiaries in 2006 and 2007. We used multivariate logistic regression to evaluate the relationship between ED use and cost-related medication nonadherence. Our principal dependent variable was any ED visit within a 364-day period after an interview assessing cost-related medication nonadherence. Our principal independent variables both denoted cost-related medication nonadherence: mild cost-related medication nonadherence, defined as a reduction in dose or a delay in filling medications because of cost; and severe cost-related medication nonadherence, defined as not filling a medication at all because of cost. Results Our sample consisted of 7,177 Medicare Current Beneficiary Survey respondents. Approximately 7.5% of respondents reported mild cost-related medication nonadherence only (n=541) and another 8.2% reported severe cost-related medication nonadherence (n=581). Disabled Medicare beneficiaries with severe cost-related medication nonadherence were more likely to have at least 1 ED visit (1.53; 95% confidence interval 1.03 to 2.26) compared with both disabled Medicare beneficiaries without cost-related medication nonadherence and elderly Medicare beneficiaries in all cost-related medication nonadherence categories. Conclusion Our results show an association between severe cost-related medication nonadherence and ED use. Disabled beneficiaries younger than 65 years who report severe cost-related medication nonadherence were more likely to have at least 1 ED visit, even when adjusting for other factors that affect utilization.

Purpose To conduct a synthesis of the literature on methods to evaluate the impacts of FDA regulatory actions and identify best practices for future evaluations. Methods We searched MEDLINE for manuscripts published between January 1948 and August 2011 that included terms related to FDA, regulatory actions, and empirical evaluation; the review additionally included FDA-identified literature. We used a modified Delphi method to identify preferred methodologies. We included studies with explicit methods to address threats to validity and identified designs and analytic methods with strong internal validity that have been applied to other policy evaluations. Results We included 18 studies out of 243 abstracts and papers screened. Overall, analytic rigor in prior evaluations of FDA regulatory actions varied considerably; less than a quarter of studies (22%) included control groups. Only 56% assessed changes in the use of substitute products/services, and 11% examined patient health outcomes. Among studies meeting minimal criteria of rigor, 50% found no impact or weak/modest impacts of FDA actions and 33% detected unintended consequences. Among those studies finding significant intended effects of FDA actions, all cited the importance of intensive communication efforts. There are preferred methods with strong internal validity that have yet to be applied to evaluations of FDA regulatory actions. Conclusions Rigorous evaluations of the impact of FDA regulatory actions have been limited and infrequent. Several methods with strong internal validity are available to improve trustworthiness of future evaluations of FDA policies. Copyright © 2013 John Wiley & Sons, Ltd.

Objective.Economic access to costly medications including biologic agents can be challenging. Our objective was to examine whether patients with rheumatoid arthritis (RA) are at particular risk for cost-related medication nonadherence (CRN) and spending less on basic needs.Methods.We identified a nationally representative sample of older adults with RA (n = 1100) in the Medicare Current Beneficiary Survey (2004–2008) and compared them to older adults with other morbidities categorized by chronic disease count: 0 (n = 5898), 1–2 (n = 30,538), and ≥ 3 (n = 34,837). We compared annual rates of self-reported CRN (skipping or reducing medication doses or not obtaining prescriptions because of cost) as well as spending less on basic needs to afford medications and tested for differences using survey-weighted logistic regression analyses adjusted for demographic characteristics, health status, and prescription drug coverage.Results.In the RA sample, the unadjusted weighted prevalence of CRN ranged from 20.7% in 2004 to 18.4% in 2008 as compared to 18.5% and 11.9%, respectively, in patients with 3 or more non-RA conditions. In adjusted analyses, having RA was associated with a 3.5-fold increase in the risk of CRN (OR 3.52, 95% CI 2.63–4.71) and almost a 2.5-fold risk of spending less on basic needs (OR 2.41, 95% CI 1.78–3.25) as compared to those without a chronic condition.Conclusion.Patients with RA experience a high prevalence of CRN and forgoing of basic needs, more than do older adults with multiple other chronic conditions. The situation did not improve during a period of policy change aimed at alleviating high drug costs.

In 2008, Massachusetts Medicaid implemented a pediatric behavioral health (BH) screening mandate. This study conducted a population-level, longitudinal policy analysis to determine the impact of the policy on ambulatory, emergency, and inpatient BH care in comparison with use of these services in California, where no similar policy exists.With Medicaid Analytic Extract (MAX) data, an interrupted time-series analysis with control series design was performed to assess changes in service utilization in the 18 months (January 2008-June 2009) after a BH screening policy was implemented in Massachusetts and to compare service utilization with California's. Outcomes included population rates of BH screening, BH-related outpatient visits, BH-related emergency department visits, BH-related hospitalizations, and psychotropic drug use. Medicaid-eligible children from January 1, 2006, to December 31, 2009, with at least ten months of Medicaid eligibility who were older than 4.5 years and younger than 18 years were included.Compared with rates in California, Massachusetts rates of BH screening and BH-related outpatient visits rose significantly after Massachusetts implemented its screening policy. BH screening rose about 13 per 1,000 youths per month during the first nine months, and BH-related outpatient visits rose to about 4.5 per 1,000 youths per month (p.001). Although BH-related emergency department visits, hospitalization and psychotropic drug use increased, there was no difference between the states in rate of increase.The goal of BH screening is to identify previously unidentified children with BH issues and provide earlier treatment options. The short-term outcomes of the Massachusetts policy suggest that screening at preventive care visits led to more BH-related outpatient visits among vulnerable children.

Some medical scientists argue that only data from randomized controlled trials (RCTs) are trustworthy. They claim data from natural experiments and administrative data sets are always spurious and cannot be used to evaluate health policies and other population-wide phenomena in the real world. While many acknowledge biases caused by poor study designs, in this article we argue that several valid designs using administrative data can produce strong findings, particularly the interrupted time series (ITS) design. Many policy studies neither permit nor require an RCT for cause-and-effect inference. Framing our arguments using Campbell and Stanley’s classic research design monograph, we show that several “quasi-experimental” designs, especially interrupted time series (ITS), can estimate valid effects (or non-effects) of health interventions and policies as diverse as public insurance coverage, speed limits, hospital safety programs, drug abuse regulation and withdrawal of drugs from the market. We further note the recent rapid uptake of ITS and argue for expanded training in quasi-experimental designs in medical and graduate schools and in post-doctoral curricula.

The ongoing flip-flopping of research findings about the effects of medical or health policies weakens the credibility of health science among the general public, clinicians, members of Congress, and the National Institutes of Health (1–3). Even worse, poorly designed studies, combined with widespread reporting on those studies by the news media, can distort the decisions of policy makers, leading them to fund ineffective, costly, or even harmful policies. Several reports in top medical journals in 2015 (4–6) pronounced that economic incentives in Pioneer Accountable Care Organizations saved medical costs, but the reports did not control for major biases created by unfairly comparing selected high-performing organizations with less-experienced control organizations (7). The result? The US Centers for Medicare & Medicaid Services cited the findings as a reason for expanding the program nationwide. Building on an earlier article in Preventing Chronic Disease (8), this article focuses on a widely accepted but questionably effective (9) health policy that compensates physicians for meeting certain quality-of-care standards, such as measuring or treating high blood pressure. Policy makers often believe that such financial incentives motivate physicians to improve their performance to maintain or increase their incomes, thereby improving patient outcomes (10). Health care systems in the United States, Canada, Germany, Israel, New Zealand, Taiwan, and the United Kingdom have committed billions of dollars to this approach in the hope that such incentives will improve the quality of health care (11). Although this monetary approach sounds good theoretically, international scientific reviews overwhelmingly find little evidence to support it (12). Giving physicians small incremental payments to do things they already do routinely (eg, measuring blood pressure) may be counterproductive and even insulting, may divert their attention from more critical concerns, and does not increase quality of care (13). Some studies even find that such compensation encourages unethical behavior by incentivizing doctors to “cherry-pick” healthy, active, wealthy patients over “costly” sick patients who are less likely to reach the performance targets. Nevertheless, this financial-incentive policy is entrenched in many components of the Patient Protection and Affordable Care Act (colloquially known as Obamacare), including Accountable Care Organizations, patient-centered medical homes, and health information technology (14). In this article, our aim is to help the public and policy makers understand how a pervasive bias can undermine the results of poorly designed studies of pay-for performance programs published in even the world’s leading medical journals. We also point to observational study designs and systematic reviews of the total body of evidence to find more trustworthy conclusions on the efficacy of pay-for-performance (12). Although randomization is frequently not feasible for evaluating such public policies (15), we also present an example of a randomized controlled trial that supports the conclusions drawn from strong observational study designs.

BACKGROUND Little is known about the effect of the Affordable Care Act's (ACA) elimination of out-of-pocket costs for preventive services. This policy likely reduced out-of-pocket colonoscopy costs most for high-deductible health plan (HDHP) members. OBJECTIVES Determine the ACA's impact on colorectal cancer screening among HDHP members. RESEARCH DESIGN Pre-post with comparison group, constructed before and after the ACA. SUBJECTS We studied 2003-2012 administrative claims data of a large national health insurer. HDHP members had 1 year of low-deductible (≤$500) plan enrollment followed by 1 year of HDHP (≥$1000) enrollment after an employer-mandated switch; HDHP enrollment occurred fully after the ACA for 21,605 members and fully before the ACA for 106,609 members. We propensity score-matched contemporaneous low-deductible (≤$500) control group members to both the before-ACA and after-ACA HDHP groups. We examined the 1-year impact of the HDHP switch separately in the before-ACA and after-ACA study cohorts, then compared these changes to estimate ACA effects. MEASURES Overall colorectal cancer screening, colonoscopy, and fecal-occult blood testing annual rates. RESULTS Before the ACA, colorectal cancer screening tests declined by 37/10,000 (-71, -4) among HDHP members versus controls; after the ACA, HDHP members experienced a nonsignificant increase in screening [+52/10,000 (-19,124)]. Corresponding changes in colonoscopy were -55/10,000 (-81, -29) before and +20/10,000 (-38, 78) after the ACA. Thus, the ACA was associated with increased colorectal cancer screening rates [+89/10,000 (11, 168); relative: +9.1% (0.5-17.8)] and screening colonoscopies [+75/10,000 (12-139); relative: +16.4% (2.5-30.3)] among HDHP members. CONCLUSION The ACA was associated with improved colorectal cancer screening among HDHP members.

Objective Recent massive investment in electronic health records (EHRs) was predicated on the assumption of improved patient safety, research capacity, and cost savings. However, most US health systems and health records are fragmented and do not share patient information. Our study compared information available in a typical EHR with more complete data from insurance claims, focusing on diagnoses, visits, and hospital care for depression and bipolar disorder.Methods We included insurance plan members aged 12 and over, assigned throughout 2009 to a large multispecialty medical practice in Massachusetts, with diagnoses of depression ( N = 5140) or bipolar disorder ( N = 462). We extracted insurance claims and EHR data from the primary care site and compared diagnoses of interest, outpatient visits, and acute hospital events (overall and behavioral) between the 2 sources.Results Patients with depression and bipolar disorder, respectively, averaged 8.4 and 14.0 days of outpatient behavioral care per year; 60% and 54% of these, respectively, were missing from the EHR because they occurred offsite. Total outpatient care days were 20.5 for those with depression and 25.0 for those with bipolar disorder, with 45% and 46% missing, respectively, from the EHR. The EHR missed 89% of acute psychiatric services. Study diagnoses were missing from the EHR’s structured event data for 27.3% and 27.7% of patients.Conclusion EHRs inadequately capture mental health diagnoses, visits, specialty care, hospitalizations, and medications. Missing clinical information raises concerns about medical errors and research integrity. Given the fragmentation of health care and poor EHR interoperability, information exchange, and usability, priorities for further investment in health IT will need thoughtful reconsideration.

OBJECTIVE The number of lawsuits accusing pharmaceutical companies of off-label marketing has risen in recent years. The impact of such lawsuits on drug prescribing and spending has not been examined. We evaluated a nationwide sample to determine whether the $430 million gabapentin off-label marketing lawsuit and accompanying media coverage affected gabapentin market share, substitution of other scientifically substantiated and unsubstantiated anticonvulsants, and anticonvulsant spending of Medicare/Medicaid patients diagnosed with bipolar disorder. METHOD Using a national 5% sample of Medicare recipients linked to Medicaid claims, we used an interrupted times series design to evaluate the impact of the lawsuit on monthly market share, utilization, and spending from January 1, 2001, to December 31, 2005. RESULTS The start of the lawsuit was associated with a 28% relative reduction in gabapentin market share (from ∼ 21% to ∼ 15%) and a reduction in the rate of prescribing from 108 prescriptions per 1,000 patients per month before the start of the lawsuit to 90 by the end of follow-up (P < .001). We also observed increases in market share for 3 other anticonvulsants. Total anticonvulsant use and spending per 1,000 patients increased by 13% and 74%, respectively, after the intervention. The increase in anticonvulsant spending was equivalent to $7,554 per 1,000 patients per year higher than expected compared with the baseline trend (P = .01). CONCLUSIONS We conclude that the lawsuit resulted in a reduction in gabapentin market share, increased market share for other anticonvulsants, and substantially increased total anticonvulsant spending to approximately half of the settlement amount, not counting substitutions of newer drugs for other illnesses affected by the lawsuit. These findings support the need for further study of the effects of current lawsuits regarding off-label drug marketing.

In October 2008, the Centers for Medicare and Medicaid Services (CMS) discontinued additional payments for certain hospital-acquired conditions that were deemed preventable. The effect of this policy on rates of health care-associated infections is unknown.Using a quasi-experimental design with interrupted time series with comparison series, we examined changes in trends of two health care-associated infections that were targeted by the CMS policy (central catheter-associated bloodstream infections and catheter-associated urinary tract infections) as compared with an outcome that was not targeted by the policy (ventilator-associated pneumonia). Hospitals participating in the National Healthcare Safety Network and reporting data on at least one health care-associated infection before the onset of the policy were eligible to participate. Data from January 2006 through March 2011 were included. We used regression models to measure the effect of the policy on changes in infection rates, adjusting for baseline trends.A total of 398 hospitals or health systems contributed 14,817 to 28,339 hospital unit-months, depending on the type of infection. We observed decreasing secular trends for both targeted and nontargeted infections long before the policy was implemented. There were no significant changes in quarterly rates of central catheter-associated bloodstream infections (incidence-rate ratio in the postimplementation vs. preimplementation period, 1.00; P=0.97), catheter-associated urinary tract infections (incidence-rate ratio, 1.03; P=0.08), or ventilator-associated pneumonia (incidence-rate ratio, 0.99; P=0.52) after the policy implementation. Our findings did not differ for hospitals in states without mandatory reporting, nor did it differ according to the quartile of percentage of Medicare admissions or hospital size, type of ownership, or teaching status.We found no evidence that the 2008 CMS policy to reduce payments for central catheter-associated bloodstream infections and catheter-associated urinary tract infections had any measurable effect on infection rates in U.S. hospitals. (Funded by the Agency for Healthcare Research and Quality.).

Cancer screening is often fully covered under high-deductible health plans (HDHP), but low socioeconomic status (SES) women still might forego testing.To determine the impact of switching to a HDHP on breast and cervical cancer screening among women of low SES.Pre-post with comparison group.Four thousand one hundred and eighty-eight health plan members enrolled for one year before and up to two years after an employer-mandated switch from a traditional HMO to an HMO-based HDHP, compared with 9418 propensity score matched controls who remained in HMOs by employer choice. Both groups had low outpatient copayments. High-deductible members had full coverage of mammography and Pap smears, but $500 to $2000 individual deductibles for most other services. HMO members had full coverage of cancer screening and low copayments for other services without any deductible. We stratified analyses by SES.Transition to a HDHP.Annual breast and cervical cancer screening rates; rates of annual preventive outpatient visits.In follow-up years 1 and 2, low SES HDHP members experienced no statistically detectable changes in rates of breast cancer screening (ratio of change, 1.14, 95 % CI, [0.93,1.40] and 1.05, [0.80,1.37], respectively) or preventive visits (difference-in-differences, +1.9 %, [-11.9 %,+17.7 %] and +10.1 %, [-9.4 %,+33.7 %], respectively) relative to HMO counterparts. Similarly, among low SES HDHP members eligible for cervical cancer screening, no significant changes occurred in either screening rates (1.01, [0.86,1.20] and 1.08, [0.86,1.35]) or preventive visits (+0.2 %, [-11.4 %,+13.3 %] and -1.4 %, [-18.1,+18.6]). Patterns were statistically similar for high SES members.During two follow-up years, transition to an HMO-based HDHP with coverage of primary care visits and cancer screening did not lead to differentially lower rates of breast and cervical cancer screening or preventive visits for low SES women. Generalizability is limited to commercially insured women transitioning to HDHPs with low cost-sharing for cancer screening and primary care visits, a common design.

Objectives The objective was to explore whether prescribing variation is associated with duration of antidepressant use during the acute phase of treatment. Improving quality of care and increasing the extent to which treatment is patient-centered and customized are interrelated goals. Prescribing variation may be considered a marker of customization, and could be associated with better antidepressant treatment adherence.

The Division of Lung Diseases of the National Heart, Lung, and Blood Institute (NHLBI) held a workshop to develop recommendations on topics, methodologies, and resources for comparative effectiveness research (CER) that will guide clinical decision making about available treatment options for lung diseases and sleep disorders. A multidisciplinary group of experts with experience in efficacy, effectiveness, implementation, and economic research identified (a) what types of studies the domain of CER in lung diseases and sleep disorders should include, (b) the criteria and process for setting priorities, and (c) current resources for and barriers to CER in lung diseases. Key recommendations were to (1) increase efforts to engage stakeholders in developing CER questions and study designs; (2) invest in further development of databases and other infrastructure, including efficient methods for data sharing; (3) make full use of a broad range of study designs; (4) increase the appropriate use of observational designs and the support of methodologic research; (5) ensure that committees that review CER grant applications include persons with appropriate perspective and expertise; and (6) further develop the workforce for CER by supporting training opportunities that focus on the methodologic and practical skills needed.

Context: The full effect of Medicare Part D, after the initial policy transition period and across the United States Medicare population, remains unclear. Objective: To estimate nationally representative changes in prescription drug use and out-of-pocket drug costs 2 years after implementation of Part D. Design, Setting, and Participants: We examined study outcomes over 8 years (2000 to 2007) and estimated changes after Part D, accounting for earlier trends. Our analyses used the communitydwelling sample of the Medicare Current Beneficiary Survey (unweighted unique n=38,798). Actual post-Part D outcomes were compared with projected values using 2000 to 2005 data. Subgroup analyses and standardization weights were used to address population-level shifts over time in health status and demographic characteristics. Main Outcome Measures: Annual prescription drug fills and outof-pocket drug costs. Results: We observed significant average per person increases of 1.8 prescription fills [95% confidence interval (CI), 1.1-2.5] in 2006 and 3.4 prescription fills (95% CI, 2.7-4.1) in 2007 above pre-Part D increases of 0.9 prescription fills per year. Average out-of-pocket drug costs decreased significantly by $143 (95% CI, � 182.5� 103.1) in 2006 and $148 (95% CI, � 181.2- � 114.1) in 2007 above average pre-Part D increases of $12 per year. Prescription fills did not change for beneficiaries with fair to poor health until 2007 when large increases occurred (increases of 3.7 to 11.0 fills above pre-Part D trends). Significant reductions in OOP drug costs occurred in 2006 and persisted into 2007 across all groups except for sick and poor beneficiaries without Medicaid. Conclusions: After the transition year of 2006, the impact of Part D seemed larger and more consistent across the Medicare population. Of note, sick and poor beneficiaries experienced significant improvements in prescription drug use in 2007.

Employers and policy makers are increasingly turning to high-deductible health plans (HDHP) to control rising health care costs (Hilzenrath 2010). From 2006 to 2010 the percentage of employees covered by plans with at least a U.S.$1000 deductible increased from 10 percent to 27 percent (Henry J. Kaiser Family Foundation [KFF] 2010). Some analysts expect that the recently passed health insurance reform legislation will lead to an “explosion” in HDHP growth (Kerber 2010). However, the growing popularity of HDHPs has been accompanied by concern that members might underutilize necessary care due to prohibitive cost sharing (Parente, Feldman, and Christianson 2004; Dixon, Greene, and Hibbard 2008). HDHPs require full cost sharing for most services until an annual deductible is met. In 2010, average deductibles for commercial health plans (i.e., HMO, PPO, POS, and savings option plans) with deductibles ranged from U.S.$601 to U.S.$1903 for individuals and U.S.$1321 to U.S.$3780 for families (KFF 2010). HDHPs associated with tax-advantaged Health Reimbursement Accounts (HRAs) or Health Savings Accounts (HSAs) to pay for qualifying medical expenses generally have higher deductibles than plans without spending accounts. Many HDHPs aim to encourage high-value care such as primary care visits and preventive services by excluding them from the deductible (KFF 2010). Although tax laws require that HSA-associated HDHPs fully subject drugs to the deductible, the majority of HDHPs utilize tiered drug copayment structures similar to traditional health plans (KFF 2010). Previous research provides compelling evidence that increased cost sharing reduces health care utilization (Newhouse 1993). The landmark RAND Health Insurance Experiment of 1971–1986 found that patients facing high-level cost sharing reduced overall utilization by approximately 33 percent (Newhouse et al. 1981) and total spending by about 30 percent (Newhouse 1993). Both appropriate and inappropriate utilization decreased, including hospitalizations, outpatient visits, and preventive services (Lohr et al. 1986; Newhouse 1993). The 2007/2008 National Health Interview Survey found that adults in HDHPs had 70 percent more unmet medical or prescription drug needs than adults in traditional health insurance plans (Cohen 2010). Studies have also demonstrated that HDHPs with full cost sharing for prescription drugs alter the use of essential medications for chronic illness, including antihypertensives, statins, cardiac medications, asthma controllers, hypoglycemics, epilepsy medications, and antiulcerants (Greene et al. 2008; Nair et al. 2009; Chen, Levin, and Gartner 2010). However, no studies have examined whether HDHPs that selectively exclude medications from full cost sharing can mitigate or prevent this reduced utilization. Such reductions could still occur if HDHP members (1) reduce contact with physicians due to cost sharing for services such as laboratory testing and radiology (providing fewer opportunities to receive prescriptions), (2) decide that overall increased levels of out-of-pocket payments for services under the deductible exceed their personal health care budget, causing reduced prescription drug purchasing, (3) are confused by complex benefit structures (Marquis 1981; Reed et al. 2009), or (4) experience “sticker shock” and subsequent decreases in generalized utilization because of a very high cost health care event such as an emergency department visit or hospitalization (Wharam et al. 2007). We studied an HDHP that subjected prescription drugs to cost sharing levels typical of traditional health plans. We examined its impact on drugs that reduce morbidity or mortality among patients with major chronic illnesses, including diabetes, hypertension, hyperlipidemia, and chronic pulmonary disease. This research has major policy relevance because most HDHP members nationally face similar drug cost-sharing arrangements (KFF 2010).

Objective:This study examined the association between a Medicaid prior-authorization policy for second-generation antipsychotic and anticonvulsant agents and medication discontinuation and health service use by patients with bipolar disorder. Methods:A pre-post design with a historical comparison group was used to analyze Maine Medicaid and Medicare claims data. A total of 946 newly treated patients were identified during the eight-month policy (July 2003–February 2004), and a comparison group of 1,014 was identified from the prepolicy period (July 2002–February 2003). Patients were stratified by number of visits to community mental health centers (CMHCs) before medication initiation (proxy for illness severity): CMHC attenders, at least two visits; nonattenders, fewer than two. Changes in rates of medication discontinuation and outpatient, emergency room, and hospital visits were estimated. Results:Compared with nonattenders, at baseline CMHC attenders had substantially higher rates of comorbid mental di...

Little is known about the long-term effects of high-deductible insurance on care for chronic medical conditions.To determine whether a transition from low-deductible to high-deductible insurance is associated with delayed medical care for macrovascular complications of diabetes.Observational longitudinal comparison of matched groups.A large national health insurer during 2003 to 2012.The intervention group comprised 33 957 persons with diabetes who were continuously enrolled in low-deductible (≤$500) insurance plans during a baseline year followed by up to 4 years in high-deductible (≥$1000) plans. The control group included 294 942 persons with diabetes who were enrolled in low-deductible plans contemporaneously with matched intervention group members.Employer-mandated transition to a high-deductible plan.The number of months it took for persons in each study group to seek care for their first major macrovascular symptom, have their first major diagnostic test for macrovascular disease, and have their first major procedure-based treatment was determined. Between-group differences in time to reach a midpoint event rate were then calculated.No baseline differences were found between groups. During follow-up, the delay for the high-deductible group was 1.5 months (95% CI, 0.8 to 2.3 months) for seeking care for the first major symptom, 1.9 months (CI, 1.4 to 2.3 months) for the first diagnostic test, and 3.1 months (CI, 0.5 to 5.8 months) for the first procedure-based treatment.Health outcomes were not examined.Among persons with diabetes, mandated enrollment in a high-deductible insurance plan was associated with delays in seeking care for the first major symptoms of macrovascular disease, the first diagnostic test, and the first procedure-based treatment.National Institute of Diabetes and Digestive and Kidney Diseases.