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1.  Rapid Rise of Breast Magnetic Resonance Imaging Use: Trends from 2000-2011 
JAMA internal medicine  2014;174(1):114-121.
Breast MRI is highly sensitive for detecting breast cancer. Low specificity, high cost and little evidence regarding mortality benefits, however, limit recommendations for its use to high risk women. How breast MRI is actually used in community settings is not known.
To describe breast MRI trends and indications in a community setting.
Retrospective cohort study.
Large not-for-profit health plan and multi-specialty group medical practice, both in New England.
: 10,518 women age 20 and older enrolled in the health plan for at least one year who had ≥ 1 breast MRIs between January 1, 2000 and December 31, 2011.
Main outcomes
Breast MRI counts were obtained from claims data. Clinical indication (screening, diagnostic evaluation, staging/treatment, or surveillance) for each MRI in the claims data was determined by a prediction model developed from electronic medical records on a subset of participants. Breast cancer risk status was assessed using claims data and, for the subset, also through electronic medical record review.
: Breast MRI use increased more than 20-fold from 6.5 per 10,000 women in 2000 to its peak of 130.7 per 10,000 in 2009. Use declined and stabilized to 104.8 per 10,000 by 2011. Screening and surveillance, rare indications in 2000, together accounted for nearly 60% of MRI use by 2011; 30% had claims-based personal and 50% family history of breast cancer, while 4% of women had a genetic mutation noted. In the subset of women who had electronic medical records and received screening or surveillance MRIs, only 21% had evidence of meeting the American Cancer Society's (ACS's) criteria for breast MRI. Conversely, only half of women with documented deleterious genetic mutations received breast MRI screening.
Breast MRI use rose steeply over ten years and then stabilized, especially for screening and surveillance among women with family or personal history of breast cancer; the majority of women receiving screening and surveillance breast MRIs did not have evidence in their medical records meeting ACS criteria and many women with mutations were not screened. Efforts are needed to ensure that breast MRI use and documentation are focused on those women who will benefit most.
PMCID: PMC4145846  PMID: 24247482
2.  Effect of the economic recession on pharmaceutical policy and medicine sales in eight European countries 
To identify pharmaceutical policy changes during the economic recession in eight European countries and to determine whether policy measures resulted in lower sales of, and less expenditure on, pharmaceuticals.
Information on pharmaceutical policy changes between 2008 and 2011 in eight European countries was obtained from publications and pharmaceutical policy databases. Data on the volume and value of the quarterly sales of products between 2006 and 2011 in the 10 highest-selling therapeutic classes in each country were obtained from a pharmaceutical market research database. We compared these indicators in economically stable countries; Austria, Estonia and Finland, to those in economically less stable countries, Greece, Ireland, Portugal, Slovakia and Spain.
Economically stable countries implemented two to seven policy changes each, whereas less stable countries implemented 10 to 22 each. Of the 88 policy changes identified, 33 occurred in 2010 and 40 in 2011. They involved changing out-of-pocket payments for patients in 16 cases, price mark-up schemes in 13 and price cuts in 11. Sales volumes increased moderately in all countries except Greece and Portugal, which experienced slight declines after 2009. Sales values decreased in both groups of countries, but fell more in less stable countries.
Less economically stable countries implemented more pharmaceutical policy changes during the recession than economically stable countries. Unexpectedly, pharmaceutical sales volumes increased in almost all countries, whereas sales values declined, especially in less stable countries.
PMCID: PMC4208566  PMID: 25378754
3.  Quality use of medicines within universal health coverage: challenges and opportunities 
Medicines are a major driver of quality, safety, equity, and cost of care in low and middle-income country health systems. Universal health coverage implementers must explicitly address appropriate use of medicines to realize the health benefits of medicines, avoid wasting scarce resources, and sustain the financial viability of universal health coverage schemes.
Medicines are major contributors to the health and well-being of individuals and populations when used appropriately, and they waste resources and endanger health when used unnecessarily or incorrectly. Stakeholders need to balance inherently competing objectives in the pharmaceutical sector. Emerging and expanding UHC schemes provide potential levers to balance competing system objectives.
To use these levers, sustainable universal coverage programs will require a) information systems that can track medicines utilization, expenditures, and quality of medicines use; b) routine monitoring of indicators of medicines availability, access, affordability, and use; c) policies and programs that facilitate appropriate medicines use by prescribers, dispensers, and patients; d) transparency in setting priorities for medicines coverage under resource constraints; and e) a system perspective to engage diverse actors.
As they operationalize paths toward universal health coverage and include targeted medicines coverage policies and programs, systems can build on, and innovate, pharmaceutical policy frameworks and management tools from different countries’ settings.
Ensuring that medicines which achieve important health outcomes are available, accessible to all, used appropriately, and sustainably affordable is essential for realizing universal health coverage. Stakeholder cooperation and use of information and financing system levers provide opportunities to work toward this goal.
PMCID: PMC4158132  PMID: 25164588
Universal health coverage; Medicines; Pharmaceutical benefit; Financial incentives; Health systems; Quality of care
4.  Impact of pharmaceutical policy interventions on utilization of antipsychotic medicines in Finland and Portugal in times of economic recession: interrupted time series analyses 
To analyze the impacts of pharmaceutical sector policies implemented to contain country spending during the economic recession – a reference price system in Finland and a mix of policies including changes in reimbursement rates, a generic promotion campaign and discounts granted to the public payer in Portugal – on utilization of, as a proxy for access to, antipsychotic medicines.
We obtained monthly IMS Health sales data in standard units of antipsychotic medicines in Portugal and Finland for the period January 2007 to December 2011. We used an interrupted time series design to estimate changes in overall use and generic market shares by comparing pre-policy and post-policy levels and trends.
Both countries’ policy approaches were associated with slight, likely unintended, decreases in overall use of antipsychotic medicines and with increases in generic market shares of major antipsychotic products. In Finland, quetiapine and risperidone generic market shares increased substantially (estimates one year post-policy compared to before, quetiapine: 6.80% [3.92%, 9.68%]; risperidone: 11.13% [6.79%, 15.48%]. The policy interventions in Portugal resulted in a substantially increased generic market share for amisulpride (estimate one year post-policy compared to before: 22.95% [21.01%, 24.90%]; generic risperidone already dominated the market prior to the policy interventions.
Different policy approaches to contain pharmaceutical expenditures in times of the economic recession in Finland and Portugal had intended – increased use of generics – and likely unintended – slightly decreased overall sales, possibly consistent with decreased access to needed medicines – impacts. These findings highlight the importance of monitoring and evaluating the effects of pharmaceutical policy interventions on use of medicines and health outcomes.
PMCID: PMC4126811  PMID: 25062657
Finland; Portugal; Antipsychotic medicines; Interrupted time series; Utilization of medicines
5.  Some Families Who Purchased Health Coverage Through The Massachusetts Connector Wound Up With High Financial Burdens 
Health affairs (Project Hope)  2013;32(5):974-983.
Health insurance exchanges created under the Affordable Care Act will offer coverage to people who lack employer-sponsored insurance or have incomes too high to qualify for Medicaid. However, plans offered through an exchange may include high levels of cost sharing. We surveyed families participating in unsubsidized plans offered in the Massachusetts Commonwealth Health Insurance Connector Authority, an exchange created prior to the 2010 national health reform law, and found high levels of financial burden and higher-than-expected costs among some enrollees. The financial burden and unexpected costs were even more pronounced for families with greater numbers of children and in families with incomes below 400 percent of the federal poverty level. We conclude that those with lower incomes, increased health care needs, and more children will be at particular risk after they obtain coverage through exchanges in 2014. Policy makers should develop strategies to further mitigate the financial burden for enrollees who are most susceptible to encountering higher-than-expected out-of-pocket costs, such as cost calculators or price transparency tools.
PMCID: PMC4103655  PMID: 23595500
6.  Improving adherence to antiretroviral treatment in Uganda with a low-resource facility-based intervention 
Global Health Action  2014;7:10.3402/gha.v7.24198.
To assess the effects of facility-based interventions using existing resources to improve overall patient attendance and adherence to antiretroviral therapy (ART) at ART-providing facilities in Uganda.
This was an interventional study which tracked attendance and treatment adherence of two distinct cohorts: experienced patients who had been on treatment for at least 12 months prior to the intervention and patients newly initiated on ART before or during the intervention. The interventions included instituting appointment system, fast-tracking, and giving longer prescriptions to experienced stable patients. Mixed-effects models were used to examine intervention effects on the experienced patients, while Cox proportional hazards models were used to determine the intervention effects on time until newly treated patients experienced gaps in medication availability.
In all, 1481 patients’ files were selected for follow-up from six facilities – 720 into the experienced cohort, and 761 into the newly treated cohort. Among patients in the experienced cohort, the interventions were associated with a significant reduction from 24.4 to 20.3% of missed appointments (adjusted odds ratio (AOR): 0.67; 95% confidence interval (CI): 0.59–0.77); a significant decrease from 20.2 to 18.4% in the medication gaps of three or more days (AOR: 0.69; 95% CI: 0.60–0.79); and a significant increase from 4.3 to 9.3% in the proportion of patients receiving more than 30 days of dispensed medication (AOR: 2.35; 95% CI: 1.91–2.89). Among newly treated patients, the interventions were associated with significant reductions of 44% (adjusted hazard rate (AHR): 0.56, 95% CI: 0.42–0.74) and 38% (AHR: 0.62; 95% CI: 0.45–0.85) in the hazards of experiencing a medication gap of 7 and 14 days or more, respectively.
Patients’ adherence was improved with low-cost and easily implemented interventions using existing health facilities’ resources. We recommend that such interventions be considered for scale-up at national levels as measures to improve clinic attendance and ART adherence among patients in Uganda and other low-resource settings in sub-Saharan Africa.
PMCID: PMC4049133  PMID: 24909408
antiretroviral therapy; adherence; management; staff motivation; intervention; Uganda
7.  The Effect of Medicare Part D on Guideline-Concordant Pharmacotherapy for Bipolar I Disorder among Dually Enrolled Beneficiaries 
In January 2006 drug insurance coverage shifted from Medicaid to Medicare Part D private drug plans for the 6 million individuals enrolled in both programs. Beneficiaries faced new formularies and utilization management policies. It is uncertain if Part D, when compared to 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.
Using interrupted time series and Medicaid and Medicare administrative data from 2004–2007, the authors analyzed the effect of the coverage transition on receipt of guideline-concordant anti-manic medication, guideline-discordant antidepressant monotherapy, and emergency department visits for a nationally-representative continuous cohort of 1,431 adults diagnosed with bipolar I disorder.
Sixteen months after the transition, the proportion of the population with any recommended anti-manic use was an estimated 3.1 percentage points higher than expected controlling for baseline trends. The monthly proportion of beneficiaries with 7+ days of antidepressant monotherapy was 2.1 percentage points lower than expected. The number of emergency department visits per month increased by 19% immediately post-transition.
Increased receipt of guideline-concordant pharmacotherapy for bipolar I disorder may reflect relatively less restrictive management of anti-manic medications under Part D. The clinical significance of these changes is unclear given the small effect sizes. However, increased emergency department visits merit attention for the Medicaid beneficiaries who continue to transition to Part D.
PMCID: PMC4038978  PMID: 24337444
To examine how enrollment in high-deductible health plans (HDHPs) affects use of well-child visits relative to traditional plans, in plans where preventive care is exempt from the deductible.
Study Design
Pre-post comparison between groups.
We selected children aged ≤ 18 years enrolled in a large Massachusetts health plan through employers offering only one type of plan. Children were in traditional plans for a 12-month baseline period between 2001 and 2004, then were either switched by a decision of the parent’s employer to an HDHP or kept in the traditional plan (controls) for a 12-month follow-up period. Preventive and other office visits were exempt from the deductible and subject to co-payments as in traditional plans. The primary outcome was whether the child received well-child visits recommended for the 12-month period. Using generalized linear mixed models, we compared the change in receipt of recommended well-child visits between baseline and follow-up for the HDHP group relative to controls.
We identified 1,598 children who were switched to HDHPs and 10,093 controls. Between baseline and follow-up, the mean proportion of recommended well-child visits received by HDHP children decreased slightly from 0.846 to 0.841, and from 0.861 to 0.855 for controls. In adjusted models, there was no significant difference in the change in probability that recommended well-child visits were received for HDHP children relative to controls (p=0.69).
Receipt of recommended well-child visits did not change for children switching to HDHPs which exempt preventive care from the deductible compared to those remaining in traditional plans.
PMCID: PMC3984915  PMID: 21348554
consumer-directed healthcare; cost sharing/co-payments; benefit design; insurance type; pediatrics; healthcare utilization
9.  Impact of Prior Authorization on the Use and Costs of Lipid-Lowering Medications Among Michigan and Indiana Dual Enrollees in Medicaid and Medicare: Results of a Longitudinal, Population-Based Study 
Clinical therapeutics  2011;33(1):135-144.
Some Medicaid programs have adopted prior-authorization (PA) policies that require prescribers to request approval from Medicaid before prescribing drugs not included on a preferred drug list.
This study examined the association between PA policies for lipid-lowering agents in Michigan and Indiana and the use and cost of this drug class among dual enrollees in Medicare and Medicaid.
Michigan and Indiana claims data from the Centers for Medicare and Medicaid Services were assessed. Michigan Medicaid instituted a PA requirement for several lipid-lowering medications in March 2002; Indiana implemented a PA policy for drugs in this class in September 2002. Although the PA policies affected some statins, they predominantly targeted second- line treatments, including bile acid sequestrants, fibrates, and niacins. Individuals aged ≥18 years who were continuously dually enrolled in both Medicare and Medicaid from July 2000 through September 2003 were included in this longitudinal, population-based study, which included a 20-month observation period before the implementation of PA in Michigan and a 12-month follow-up period after the Indiana PA policy was initiated. Interrupted time series analysis was used to examine changes in prescription rates and pharmacy costs for lipid-lowering drugs before and after policy implementation.
A total of 38,684 dual enrollees in Michigan and 29,463 in Indiana were included. Slightly more than half of the cohort were female (Michigan, 53.3% [20,614/38,684]; Indiana, 56.3% [16,595/29,463]); nearly half were aged 45 to 64 years (Michigan, 43.7% [16,921/38,684]; Indiana, 45.2% [13,321/29,463]). Most subjects were white (Michigan, 77.4% [29,957/ 38,684]; Indiana: 84.9% [25,022/29,463]). The PA policy was associated with an immediate 58% reduction in prescriptions for nonpreferred medications in Michigan and a corresponding increase in prescriptions for preferred agents. However, the PA policy had no apparent effect in Indiana, where there had been little use of non-preferred medications before the policy was implemented (3.3%). The policies were associated with an immediate reduction of $24,548 in prescription expenditures in Michigan and an immediate reduction of $16,070 in Indiana.
The PA policy was associated with substantially lower use of nonpreferred lipid-lowering drugs in Michigan, offset by increases in the use of preferred medications, but there was less change in Indiana. Data limitations did not permit the evaluation of the impact of policy-induced switching on clinical outcomes such as cholesterol levels. The monetary benefit of PA policies for lipid-lowering agents should be weighed against administrative costs and the burden on patients and health care providers.
PMCID: PMC3980661  PMID: 21397779
drug expenditure; drug utilization; lipid-lowering drugs; Medicaid; prior authorization; statins
10.  The Experience Of Massachusetts Shows That Consumers Will Need Help In Navigating Insurance Exchanges 
Health affairs (Project Hope)  2013;32(1):78-86.
In 2022 twenty-five million people are expected to purchase health insurance through exchanges to be established under the Affordable Care Act. Understanding how people seek information and make decisions about the insurance plans that are available to them may improve their ability to select a plan and their satisfaction with it. We conducted a survey in 2010 of enrollees in one plan offered through Massachusetts’s unsubsidized health insurance exchange to analyze how a sample of consumers selected their plans. More than 40 percent found plan information difficult to understand. Approximately one-third of respondents had help selecting plans—most commonly from friends or family members. However, one-fifth of respondents wished they had had help narrowing plan choices; these enrollees were more likely to report negative experiences related to plan understanding, satisfaction with affordability and coverage, and unexpected costs. Some may have been eligible for subsidized plans. Exchanges may need to provide more resources and decision-support tools to improve consumers’ experiences in selecting a health plan.
PMCID: PMC3950973  PMID: 23297274
11.  Impact of Two Medicaid Prior-Authorization Policies on Antihypertensive Use and Costs Among Michigan and Indiana Residents Dually Enrolled in Medicaid and Medicare: Results of a Longitudinal, Population-Based Study 
Clinical therapeutics  2010;32(4):10.1016/j.clinthera.2010.04.007.
In response to rising pharmaceutical costs, many state Medicaid programs have implemented policies requiring prior authorization for high-cost medications, even for established users. However, little is known about the impact of these policies on the use of antihypertensive medicines in the United States.
The aim of this longitudinal, population-based study was to assess comprehensive prior-authorization programs for antihypertensives on drug use and costs in a vulnerable Medicaid population in Michigan and Indiana.
A prior-authorization policy for anti-hypertensives was implemented in Michigan in March 2002 and in Indiana in September 2002; Indiana also implemented an antihypertensive stepwise-therapy requirement in July 2003. Our study cohort included individuals aged ≥18 years in Michigan and Indiana who were continuously enrolled in both Medicaid and Medicare from July 2000 through September 2003. Claims data were obtained from the Centers for Medicare and Medicaid Services. We included all antihypertensive medications, including diuretics, angiotensin-converting enzyme inhibitors, calcium channel blockers, β-blockers, α-blockers, and angiotensin II receptor blockers. We used interrupted time-series analysis to study policy-related changes in the total number and cost of anti-hypertensive prescriptions.
Overall, 38,684 enrollees in Michigan and 29,463 in Indiana met our inclusion criteria. Slightly more than half of our cohort in both states was female (53.29% in Michigan and 56.32% in Indiana). In Michigan, 20.23% of patients were aged ≥65 years; 77.44% were white, 20.11% were black, and the remainder were Hispanic, Native American, Asian, or of other or unknown race. In Indiana, 20.07% were aged ≥65 years; 84.93% were white, 13.64% were black, and the remainder were Hispanic, Native American, Asian, or of other or unknown race. The implementation of both policies was associated with large and immediate reductions in the use of nonpreferred medications: 83.33% reduction in the use of such drugs in Michigan (−84.30 prescriptions per 1000 enrollees per month; P < 0.001) and 35.76% in Indiana (−64.45 prescriptions per 1000 enrollees per month; P < 0.001). As expected, use of preferred medications also increased substantially in both states (P < 0.001). Overall, antihypertensive therapy immediately dropped 0.16% in Michigan (P = 0.04) and 1.82% in Indiana (P = 0.02). Implementation of the policies was also associated with reductions in pharmacy reimbursement of $616,572.43 in Michigan and $868,265.97 in Indiana in the first postpolicy year.
Prior authorization was associated with lower use of nonpreferred antihypertensive drugs that was largely offset by increases in the use of preferred drugs. The possible clinical consequences of policy-induced drug switching for individual patients remain unknown because the present study did not include access to medical record data. Further research is needed to establish whether large-scale switches in medicines following the inception of prior-authorization policies have any long-term health effects.
PMCID: PMC3844690  PMID: 20435243
prior authorization; Medicaid; anti-hypertensive; drug utilization; costs
12.  Access to medicines for acute illness in middle income countries in Central America 
Revista de Saúde Pública  2013;47(6):1069-1079.
To analyze the main predictors of access to medicines for persons who experienced acute health conditions.
This was a cross-sectional analytic study, based on data from household surveys. We examined the predictors of: (1) seeking care for acute illness in the formal health care system and (2) obtaining all medicines sought for the acute condition.
The significant predictors of seeking health care for acute illnesses were urban geographic location, head of household with secondary school education or above, age under 15, severity of illness perceived by the respondent, and having health insurance. The most important predictor of obtaining full access to medicines was seeking care in the formal health care system. People who sought care in the formal system were three times more likely to receive all the medicines sought (OR 3.0, 95%CI 2.3;4.0). For those who sought care in the formal health system, the strongest predictors of full access to medicines were seeking care in the private sector, having secondary school education or above, and positive perceptions of quality of health care and medicines in public sector health facilities. For patients who did not seek care in the formal health system, full access to medicines was more likely in Honduras or Nicaragua than in Guatemala. Urban geographic location, higher economic status, and male gender were also significant predictors.
A substantial part of the population in these three countries sought and obtained medicines outside of the formal health care system, which may compromise quality of care and pose a risk to patients. Determinants of full access to medicines inside and outside the formal health care system differ, and thus may require different strategies to improve access to medicines. 
PMCID: PMC4206104  PMID: 24626545
Pharmaceutical Preparations; Health Services Accessibility; Communicable Disease Control; Health Surveys, utilization; Cross-Sectional Studies
13.  Methods for estimating confidence intervals in interrupted time series analyses of health interventions 
Journal of clinical epidemiology  2008;62(2):10.1016/j.jclinepi.2008.08.007.
Interrupted time series is a strong quasi-experimental research design that is increasingly applied to estimate the effects of health services and policy interventions. We describe and illustrate two methods for estimating confidence intervals around absolute and relative changes in outcomes calculated from segmented regression parameter estimates.
Study Design and Setting
We used multivariate delta and bootstrapping methods to construct confidence intervals around relative changes in level and trend and around absolute changes in outcome based on segmented linear regression analyses of time series data corrected for auto-correlated errors.
Using previously published time series data, we estimated confidence intervals around the effect of prescription alerts for interacting medications with warfarin on the rate of prescriptions per 10,000 warfarin users per month. Both the multivariate delta method and the bootstrapping method produced similar results.
The bootstrapping method is preferred for calculating confidence intervals of relative changes in outcomes of time series studies since it does not require large sample sizes when parameter estimates are obtained correctly from the model. Caution is needed when sample size is small.
PMCID: PMC3828652  PMID: 19010644
Interrupted time series; Segmented regression; Confidence interval; Relative change; Bootstrapping; Delta method
14.  The Relationship Between Emergency Department Use and Cost-Related Medication Nonadherence Among Medicare Beneficiaries 
Annals of emergency medicine  2013;62(5):10.1016/j.annemergmed.2013.04.013.
The objective of this study was to evaluate the relationship between self reported cost-related nonadherence to medications and emergency department utilization among a population of Medicare beneficiaries. We hypothesized that persons who reported cost-related medication nonadherence (CRN) would have higher emergency department (ED) use.
We conducted a retrospective cohort study of continuously enrolled Medicare beneficiaries from in 2006 and 2007. We used multivariate logistic regression to evaluate the relationship between ED use and CRN. Our principal dependent variable was any emergency department visit within a 364-day period after the initial interview assessing CRN. Our principal independent variables were two variables to denote CRN: mild CRN, defined as a reduction in medication dose or delay in getting medications because of cost, and severe CRN, defined as a medication not being filled at all due to cost.
Our sample consisted of 7177 Medicare Cost Beneficiary Survey (MCBS) MCBS respondents. Approximately 7.5 percent of these respondents reported mild CRN only (n=541) and another 8.2 percent reported severe CRN (n=581). Disabled Medicare beneficiaries with severe CRN were more likely to have at least one ED visit (1.53, 95% CI 1.03–2.26) as compared to both disabled Medicare beneficiaries without CRN and elderly Medicare beneficiaries in all CRN categories.
Our results show an association between severe CRN and emergency department use. Disabled beneficiaries under age 65 who report severe CRN were more likely to have at least one emergency department visit, even when adjusting for other factors that impact utilization.
PMCID: PMC3812390  PMID: 23726522
15.  Effect of Switching to a High-Deductible Health Plan on Use of Chronic Medications 
Health Services Research  2011;46(5):1382-1401.
To examine whether high-deductible health plans (HDHPs) that exempt prescription drugs from full cost sharing preserve medication use for major chronic illness, compared with traditional HMOs with similar drug cost sharing.
Data Sources/Study Setting
We examined 2001–2008 pharmacy claims data of 3,348 continuously enrolled adults in a Massachusetts health plan for 9 months before and 24 months after an employer-mandated switch from a traditional HMO plan to a HDHP, compared with 20,534 contemporaneous matched HMO members. Both study groups faced similar three-tiered drug copayments. We calculated daily medication availability for all prescription drugs and four chronic medication classes: hypoglycemics, lipid-lowering agents, antihypertensives, and chronic obstructive pulmonary disease (COPD)/asthma controllers.
Study Design
Interrupted time-series with comparison group study design examining monthly level and trend changes in prescription drug utilization.
Principal Findings
The HDHP and control groups had comparable changes in the level and trend of all drugs after the index date; we detected similar patterns in the use of lipid-lowering agents, antihypertensives, and COPD/asthma controllers. Some evidence suggested a small relative decline in hypoglycemic use among diabetic patients in HDHPs.
Switching to an HDHP that included modest drug copayments did not change medication availability or reduce use of essential medications for three common chronic illnesses.
PMCID: PMC3207183  PMID: 21413983
High-deductible health plans; pharmaceutical use; chronic disease; differential cost-sharing
16.  Cost-Related Medication Nonadherence and Spending on Basic Needs Following Medicare Part D 
Cost-related medication nonadherence (CRN) has been a persistent problem for elderly and disabled Americans. The impact of Medicare prescription drug coverage (Part D) on CRN is unknown.
To estimate changes in CRN and forgoing basic needs to pay for drugs following Part D implementation.
Design, Setting, and Participants
In a population-level design, we compared changes in study outcomes from 2005 to 2006, before and after Part D, to historical changes from 2004 to 2005. We used the community-dwelling sample of the nationally representative Medicare Current Beneficiary Survey (unweighted unique n=24,234, response rate =72.3%) Logistic regression analyses controlled for demographic characteristics, health status, and historical trends.
Main Outcome Measures
Self-reports of cost-related nonadherence (skipping or reducing doses, not obtaining prescriptions) and spending less on basic needs in order to afford medicines.
The unadjusted, weighted prevalence of CRN was 15.2% in 2004, 14.1% in 2005, and 11.5% after Part D in 2006; the prevalence of spending less on basic needs was 10.6% in 2004, 11.1% in 2005, and 7.6% in 2006. Adjusted analyses comparing 2006 to 2005, controlling for historical changes (2005 versus 2004), demonstrated significant decreases in the odds of CRN (OR ratio, 0.85; 95% CI, 0.74–0.98; P = .03) and spending less on basic needs (OR ratio, 0.59; 95% CI, 0.48–0.72; P < .000). No significant changes in CRN were observed among beneficiaries with fair-to-poor health (OR ratio, 1.00; 95% CI, 0.82–1.21; P = .97), despite high baseline CRN prevalence for this group (22.2% in 2005) and significant decreases among those with good-to-excellent health (OR ratio, 0.77; 95% CI, 0.63–0.95; P = .02). However, we did detect significant reductions in spending less on basic needs in both groups (OR ratio, 0.60; 95% CI, 0.47–0.75; P < .000, for fair-to-poor health; OR ratio, 0.57; 95% CI, 0.44–0.75; P < .000 for good-to-excellent health).
In this survey population, there was evidence for a small but significant overall decrease in cost-related nonadherence and forgoing basic needs following Part D implementation. However, we detected no net decrease in CRN after Part D among the sickest beneficiaries, who continued to experience higher rates of CRN.
PMCID: PMC3781951  PMID: 18430911
18.  Cost-Related Medication Nonadherence and Cost-Saving Strategies Used by Elderly Medicare Cancer Survivors 
To compare cost-related medication nonadherence among elderly Medicare enrollees with and without cancer, and to describe the strategies cancer survivors used to offset the costs of medications.
Using the 2005 Medicare Current Beneficiary Survey and Medicare claims, we compared self-reported cost-related medication nonadherence (CRN), spending less on basic needs to afford medicines, and cost-reduction strategies among elderly beneficiaries with and without cancer. Descriptive statistics and logistic regression models were used to characterize and compare these populations.
In a nationally representative sample of 9818 non-institutionalized elderly Medicare enrollees, 1392 (14%) were classified as cancer survivors based on Medicare claims. Cancer survivors were older, more highly educated, more likely to be male and non-Hispanic, and more likely to have multiple co-morbidities, poorer health status, and employer-paid medication coverage. While 10% of cancer survivors and 11% without cancer reported CRN; about 6% and 9% (p=0.004) of those with and without cancer, respectively, reported spending less on basic needs to offset the costs of medications. Cancer survivors who reported CRN (n=143) had lower income (62.2% versus 48.6%, p=0.11), and were more likely to be African-American (13.0% versus 6.4%, p=0.033), and have non-employer-based medication insurance (p=0.002) compared to those who did not report CRN. In adjusted analyses, CRN among the two groups was similar, but with some subgroup differences noted by gender and cancer type. Use of cost-reduction strategies was mostly similar among cancer survivors and those without cancer.
Cost-related medication nonadherence medication is common among elderly Medicare beneficiaries, but appears to be similar among those with and without cancer.
PMCID: PMC3767465  PMID: 21800053
cancer survivorship; cost; adherence; Medicare; elderly
19.  Delayed and Forgone Care for Families with Chronic Conditions in High-Deductible Health Plans 
Journal of General Internal Medicine  2012;27(9):1105-1111.
High-deductible health plans (HDHPs) are an increasingly common strategy to contain health care costs. Individuals with chronic conditions are at particular risk for increased out-of-pocket costs in HDHPs and resulting cost-related underuse of essential health care.
To evaluate whether families with chronic conditions in HDHPs have higher rates of delayed or forgone care due to cost, compared with those in traditional health insurance plans.
This mail and phone survey used multiple logistic regression to compare family-level rates of reporting delayed/forgone care in HDHPs vs. traditional plans.
We selected families with children that had at least one member with a chronic condition. Families had employer-sponsored insurance in a Massachusetts health plan and >12 months of enrollment in an HDHP or a traditional plan.
Main Measures
The primary outcome was report of any delayed or forgone care due to cost (acute care, emergency department visits, chronic care, checkups, or tests) for adults or children during the prior 12 months.
Respondents included 208 families in HDHPs and 370 in traditional plans. Membership in an HDHP and lower income were each independently associated with higher probability of delayed/forgone care due to cost. For adult family members, the predicted probability of delayed/forgone care due to cost was higher in HDHPs than in traditional plans [40.0% vs 15.1% among families with incomes <400% of the federal poverty level (FPL) and 16.0% vs 4.8% among those with incomes ≥400% FPL]. Similar associations were observed for children.
Among families with chronic conditions, reporting of delayed/forgone care due to cost is higher for both adults and children in HDHPs than in traditional plans. Families with lower incomes are also at higher risk for delayed/forgone care.
PMCID: PMC3514993  PMID: 22249829
health insurance; deductible; cost sharing; utilization; health policy
20.  Two-year Trends in Cancer Screening Among Low Socioeconomic Status Women in an HMO-based High-deductible Health Plan 
Journal of General Internal Medicine  2012;27(9):1112-1119.
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.
PMCID: PMC3515008  PMID: 22544705
high-deductible health plans; cancer screening; vulnerable populations; women’s health
21.  Health care payments in the asia pacific: validation of five survey measures of economic burden 
Many low and middle-income countries rely on out-of-pocket payments to help finance health care. These payments can pose financial hardships for households; valid measurement of this type of economic burden is therefore critical. This study examines the validity of five survey measures of economic burden caused by health care payments.
We analyzed 2002/03 World Health Survey household-level data from four Asia Pacific countries to assess the construct validity of five measures of economic burden due to health care payments: any health expenditure, health expenditure amount, catastrophic health expenditure, indebtedness, and impoverishment. We used generalized linear models to assess the correlations between these measures and other constructs with which they have expected associations, such as health care need, wealth, and risk protection.
Measures of impoverishment and indebtedness most often correlated with health care need, wealth, and risk protection as expected. Having any health expenditure, a large health expenditure, or even a catastrophic health expenditure did not consistently predict degree of economic burden.
Studies that examine economic burden attributable to health care payments should include measures of impoverishment and indebtedness.
PMCID: PMC3716807  PMID: 23822552
Out-of-pocket payment; Economic burden; Valid measurement; World Health Survey
22.  Facility-level intervention to improve attendance and adherence among patients on anti-retroviral treatment in Kenya—a quasi-experimental study using time series analysis 
Achieving high rates of adherence to antiretroviral therapy (ART) in resource-poor settings comprises serious, but different, challenges in both the first months of treatment and during the life-long maintenance phase. We measured the impact of a health system-oriented, facility-based intervention to improve clinic attendance and patient adherence.
This was a quasi-experimental, longitudinal, controlled intervention study using interrupted time series analysis. The intervention consisted of (1) using a clinic appointment diary to track patient attendance and monitor monthly performance; (2) changing the mode of asking for self-reported adherence; (3) training staff on adherence concepts, intervention methods, and use of monitoring data; (4) conducting visits to support facility teams with the implementation.
We conducted the study in 12 rural district hospitals (6 intervention, 6 control) in Kenya and randomly selected 1894 adult patients over 18 years of age in two cohorts: experienced patients on treatment for at least one year, and newly treated patients initiating ART during the study. Outcome measures were: attending the clinic on or before the date of a scheduled appointment, attending within 3 days of a scheduled appointment, reporting perfect adherence, and experiencing a gap in medication supply of more than 14 days.
Among experienced patients, the percentage attending the clinic on or before a scheduled appointment increased in both level (average total increase immediately after intervention) (+5.7%; 95% CI = 2.1, 9.3) and trend (increase per month) (+1.0% per month; 95% CI = 0.6, 1.5) following the intervention, as did the level and trend of those keeping appointments within three days (+4.2%; 95% CI = 1.6, 6.7; and +0.8% per month; 95% CI = 0.6, 1.1, respectively). The relative difference between the intervention and control groups based on the monthly difference in visit rates increased significantly in both level (+6.5; 95% CI = 1.4, 11.6) and trend (1.0% per month; 95% CI = 0.2, 1.8) following the intervention for experienced patients attending the clinic within 3 days of their scheduled appointments.
The decrease in the percentage of experienced patients with a medication gap greater than 14 days approached statistical significance (-11.3%; 95% CI = -22.7, 0.1), and the change seemed to persist over 11 months after the intervention. All facility staff used appointment-keeping data to calculate adherence and discussed outcomes regularly.
The appointment-tracking system and monthly performance monitoring was strengthened, and patient attendance was improved. Scale-up to national level may be considered.
PMCID: PMC3704969  PMID: 23816278
Appointment-keeping; Medication gaps; Self-reported adherence; Indicators; Monitoring performance
23.  Need for and Access to Health Care and Medicines: Are There Gender Inequities? 
PLoS ONE  2013;8(3):e57228.
Differences between women and men in political and economic empowerment, education, and health risks are well-documented. Similar gender inequities in access to care and medicines have been hypothesized but evidence is lacking.
We analyzed 2002 World Health Survey data for 257,922 adult respondents and 80,932 children less than 5 years old from 53 mostly low and middle-income countries. We constructed indicators of need for, access to, and perceptions of care, and we described the number of countries with equal and statistically different proportions of women and men for each indicator. Using multivariate logistic regression models, we estimated effects of gender on our study outcomes, overall and by household poverty.
Women reported significantly more need for care for three of six chronic conditions surveyed, and they were more likely to have at least one of the conditions (OR 1.41 [95% CI 1.38, 1.44]). Among those with reported need for care, there were no consistent differences in access to care between women and men overall (e.g., treatment for all reported chronic conditions, OR 1.00 [0.96, 1.04]) or by household poverty. Of concern, access to care for chronic conditions was distressingly low among both men and women in many countries, as was access to preventive services among boys and girls less than 5 years old.
These cross-country results do not suggest a systematic disadvantage of women in access to curative care and medicines for treating selected chronic conditions or acute symptoms, or to preventive services among boys and girls.
PMCID: PMC3591435  PMID: 23505420
24.  Impact of Emerging Health Insurance Arrangements on Diabetes Outcomes and Disparities: Rationale and Study Design 
Consumer-directed health plans combine lower premiums with high annual deductibles, Internet-based quality-of-care information, and health savings mechanisms. These plans may encourage members to seek better value for health expenditures but may also decrease essential care. The expansion of high-deductible health plans (HDHPs) represents a natural experiment of tremendous proportion. We designed a pre–post, longitudinal, quasi-experimental study to determine the effect of HDHPs on diabetes quality of care, outcomes, and disparities. We will use a 13-year rolling sample (2001–2013) of members of an HDHP and members of a control group. To reduce selection bias, we will limit participants to those whose employers mandate a single health insurance type. The study will measure rates of monthly hemoglobin A1c, lipid, and albuminuria testing; availability of blood glucose test strips; and rates of retinal examinations, high-severity emergency department visits, and preventable hospitalizations. Results could be used to design health plan features that promote high-quality care and better outcomes among people who have diabetes.
PMCID: PMC3562172  PMID: 23369764
25.  Impact of universal health insurance coverage in Thailand on sales and market share of medicines for non-communicable diseases: an interrupted time series study 
BMJ Open  2012;2(6):e001686.
In 2001, Thailand implemented the Universal Coverage Scheme (UCS), a public insurance system that aimed to achieve universal access to healthcare, including essential medicines, and to influence primary care centres and hospitals to use resources efficiently, via capitated payment for outpatient services and other payment policies for inpatient care. Our objective was to evaluate the impact of the UCS on utilisation of medicines in Thailand for three non-communicable diseases: cancer, cardiovascular disease and diabetes.
Interrupted time-series design, with a non-equivalent comparison group.
Thailand, 1998–2006.
Quarterly purchases of medicines from hospital and retail pharmacies collected by IMS Health between 1998 and 2006.
UCS implementation, April–October 2001.
Outcome measures
Total pharmaceutical sales volume and percent market share by licensing status and National Essential Medicine List status.
The UCS was associated with long-term increases in sales of medicines for conditions that are typically treated in outpatient primary care settings, such as diabetes, high cholesterol and high blood pressure, but not for medicines for diseases that are typically treated in secondary or tertiary care settings, such as heart failure, arrhythmias and cancer. Although the majority of increases in sales were for essential medicines, there were also postpolicy increases in sales of non-essential medicines. Immediately following the reform, there was a significant shift in hospital sector market share by licensing status for most classes of medicines. Government-produced products often replaced branded generic or generic competitors.
Our results suggest that expanding health insurance coverage with a medicine benefit to the entire Thai population increased access to medicines in primary care. However, our study also suggests that the UCS may have had potentially undesirable effects. Evaluations of the long-term impacts of universal health coverage on medicine utilisation are urgently needed.
PMCID: PMC3533018  PMID: 23192243
Essential Medicines; Cardiology; Diabetes & Endocrinology; Oncology

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