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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
2.  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
3.  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
4.  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
5.  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
6.  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
7.  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
8.  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
10.  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
11.  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
12.  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
13.  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
14.  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
15.  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
16.  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
17.  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
18.  Medicare Part D and Changes in Prescription Drug Use and Cost Burden: National Estimates for the Medicare Population, 2000–2007 
Medical care  2011;49(9):834-841.
The full effect of Medicare Part D, after the initial policy transition period and across the U.S. Medicare population, remains unclear.
To estimate nationally-representative changes in prescription drug use and out-of-pocket drug costs two years after implementation of Part D.
Design, Setting, and Participants
We examined study outcomes over 8 years (2000–2008) and estimated changes after Part D, accounting for prior trends. Our analyses used the community-dwelling sample of the Medicare Current Beneficiary Survey (unweighted unique n=38,798). Actual post-Part D outcomes were compared to projected values using 2000–2005 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 out-of-pocket drug costs.
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). Poor beneficiaries without Medicaid had no reductions in out-of-pocket drug costs in 2006 or 2007.
After the transition year of 2006, the impact of Part D appeared larger and more consistent across the Medicare population. Of note, sick and poor beneficiaries experienced significant improvements in prescription drug use in 2007.
PMCID: PMC3151472  PMID: 21544002
19.  Evaluating quality of care for patients with type 2 diabetes using electronic health record information in Mexico 
Several low and middle-income countries are implementing electronic health records (EHR). In the near future, EHRs could become an efficient tool to evaluate healthcare performance if appropriate indicators are developed. The aims of this study are: a) to develop quality of care indicators (QCIs) for type 2 diabetes (T2DM) in the Mexican Institute of Social Security (IMSS) health system; b) to determine the feasibility of constructing QCIs using the IMSS EHR data; and c) to evaluate the quality of care (QC) provided to IMSS patients with T2DM.
We used a three-stage mixed methods approach: a) development of QCIs following the RAND-UCLA method; b) EHR data extraction and construction of indicators; c) QC evaluation using EHR data from 25,130 T2DM patients who received care in 2009.
We developed 18 QCIs, of which 14 were possible to construct using available EHR data. QCIs comprised both process of care and health outcomes. Several flaws in the EHR design and quality of data were identified. The indicators of process and outcomes of care suggested areas for improvement. For example, only 13.0% of patients were referred to an ophthalmologist; 3.9% received nutritional counseling; 63.2% of overweight/obese patients were prescribed metformin, and only 23% had HbA1c <7% (or plasma glucose ≤130 mg/dl).
EHR data can be used to evaluate QC. The results identified both strengths and weaknesses in the electronic information system as well as in the process and outcomes of T2DM care at IMSS. This information can be used to guide targeted interventions to improve QC.
PMCID: PMC3437217  PMID: 22672471
20.  Association Between Prior Authorization for Psychiatric Medications and Use of Health Services Among Medicaid Patients With Bipolar Disorder 
Prior authorization policies are commonly used by Medicaid programs to control psychotropic drug expenditures. This study examined the association of a prior-authorization policy for atypical antipsychotic and anticonvulsant agents with medication discontinuation and use of health services among patients with bipolar disorder.
A pre-post-with-historical-comparison-group design was used to analyze Maine Medicaid and Medicare claims data. Newly treated patients were identified during the policy (Jul 2003–Feb 2004; N=946) and a comparison group from the pre-policy period (Jul 2002–Feb 2003; N=1,014). Patients were stratified according to their pre-initiation visits to community mental health centers (CMHCs) that target those with the most serious mental illness: CMHC-attenders (at least 2 visits) and non-attenders (fewer than 2 visits). Changes in rates of medication discontinuation, outpatient, emergency room and hospital visits before and after drug initiation were estimated.
CMHC-attenders had substantially higher rates of comorbidity and use of medications and health services than non-attenders. The policy was associated with increased medication discontinuation in both groups; reductions in psychiatric visits after discontinuing medication among CMHC-attenders (−64/100 patients/month; p<.05); and increases in emergency room visits after discontinuing medication among non-attenders (16/100 patients/month; p<.05). During the 8-month follow-up, the policy had no detectable impact on risk of hospitalization.
The Maine prior-authorization policy was associated with increased medication discontinuation and subsequent changes in use of health services. Though small, these unintended policy effects raise quality of care concerns for a group of very vulnerable patients. Long-term consequences of prior-authorization policies on patient outcomes warrant further investigation.
PMCID: PMC3053119  PMID: 21285097
prior authorization; bipolar disorder; policy evaluation; Medicaid; health services research
21.  Improving Diabetes Care Among Patients Overdue for Recommended Testing: A Randomized Controlled Trial of Automated Telephone Outreach 
Diabetes Care  2010;33(7):1452-1453.
The study's objective was to assess the effects of automated telephone outreach with speech recognition (ATO-SR) on diabetes-related testing.
We identified 1,200 health plan members who were overdue for diabetes-related testing and randomly allocated 600 to ATO-SR and 600 to usual care (no intervention). The intervention included three interactive calls encouraging recommended testing. The primary outcome was retinopathy testing, since this was the health plan's principal goal. Tests for glycemia, hyperlipidemia, and nephropathy were secondary outcomes.
In total, 232 participants (39%) verbally responded to the calls. There was no difference between the intervention and the usual care groups in the primary outcome (adjusted hazard ratio 0.93 [95% CI 0.71–1.22]) and no effect of the intervention on any of the secondary outcomes.
Fewer than 40% of the patients randomized to ATO-SR interacted verbally with the system. The intervention had no effect on the study's outcomes.
PMCID: PMC2890338  PMID: 20357376
22.  Out-of-Pocket Burden of Health Care Spending and the Adequacy of the Medicare Part D Low-Income Subsidy 
Medical care  2010;48(6):503-509.
Little is known about how much Medicare families can afford to pay for health care and whether the Medicare prescription drug program (Part D) will provide financial protection. In this paper we assess total out-of-pocket health care spending of Medicare families in the context of their available resources in the year prior to Part D. We find that high health spending burdens are common. Medicare families with incomes up to 250% of the Federal Poverty Level are at high risk for incurring burdensome health care costs, and this includes many who would not be eligible for Part D Low-income subsidy assistance.
PMCID: PMC3084515  PMID: 20473197
23.  Effect of pay for performance on the management and outcomes of hypertension in the United Kingdom: interrupted time series study 
Objective To assess the impact of a pay for performance incentive on quality of care and outcomes among UK patients with hypertension in primary care.
Design Interrupted time series.
Setting The Health Improvement Network (THIN) database, United Kingdom.
Participants 470 725 patients with hypertension diagnosed between January 2000 and August 2007.
Intervention The UK pay for performance incentive (the Quality and Outcomes Framework), which was implemented in April 2004 and included specific targets for general practitioners to show high quality care for patients with hypertension (and other diseases).
Main outcome measures Centiles of systolic and diastolic blood pressures over time, rates of blood pressure monitoring, blood pressure control, and treatment intensity at monthly intervals for baseline (48 months) and 36 months after the implementation of pay for performance. Cumulative incidence of major hypertension related outcomes and all cause mortality for subgroups of newly treated (treatment started six months before pay for performance) and treatment experienced (started treatment in year before January 2001) patients to examine different stages of illness.
Results After accounting for secular trends, no changes in blood pressure monitoring (level change 0.85, 95% confidence interval −3.04 to 4.74, P=0.669 and trend change −0.01, −0.24 to 0.21, P=0.615), control (−1.19, −2.06 to 1.09, P=0.109 and −0.01, −0.06 to 0.03, P=0.569), or treatment intensity (0.67, −1.27 to 2.81, P=0.412 and 0.02, −0.23 to 0.19, P=0.706) were attributable to pay for performance. Pay for performance had no effect on the cumulative incidence of stroke, myocardial infarction, renal failure, heart failure, or all cause mortality in both treatment experienced and newly treated subgroups.
Conclusions Good quality of care for hypertension was stable or improving before pay for performance was introduced. Pay for performance had no discernible effects on processes of care or on hypertension related clinical outcomes. Generous financial incentives, as designed in the UK pay for performance policy, may not be sufficient to improve quality of care and outcomes for hypertension and other common chronic conditions.
PMCID: PMC3026849  PMID: 21266440
24.  The population-level impacts of a national health insurance program and franchise midwife clinics on achievement of prenatal and delivery care standards in the Philippines 
Adequate prenatal and delivery care are vital components of successful maternal health care provision. Starting in 1998, two programs were widely expanded in the Philippines: a national health insurance program (PhilHealth); and a donor-funded franchise of midwife clinics (Well-Family Midwife Clinics). This paper examines population-level impacts of these interventions on achievement of minimum standards for prenatal and delivery care.
Data from two waves of the Demographic and Health Surveys, conducted before (1998) and after (2003) scale up of the interventions, are employed in a pre/post study design, using longitudinal multivariate logistic and linear regression models.
After controlling for demographic and socioeconomic characteristics, the PhilHealth insurance program scale up was associated with increased odds of receiving at least four prenatal visits (OR 1.04 [95% CI 1.01–1.06]) and receiving a visit during the first trimester of pregnancy (OR 1.03 [95% CI 1.01–1.06]). Exposure to midwife clinics was not associated with significant changes in achievement of prenatal care standards. While both programs were associated with slight increases in the odds of delivery in a health facility, these increases were not statistically significant.
These results suggest that expansion of an insurance program with accreditation standards was associated with increases in achievement of minimal standards for prenatal care among women in the Philippines.
PMCID: PMC2719679  PMID: 19327862
maternal health; prenatal and delivery care; national health insurance program; social franchising; Philippines
25.  Reducing the Prescribing of Heavily Marketed Medications: A Randomized Controlled Trial 
Prescription drug costs are a major component of health care expenditures, yet resources to support evidence-based prescribing are not widely available.
To evaluate the effectiveness of computerized prescribing alerts, with or without physician-led group educational sessions, to reduce the prescribing of heavily marketed hypnotic medications.
Cluster-randomized controlled trial.
We randomly allocated 14 internal medicine practice sites to receive usual care, computerized prescribing alerts alone, or alerts plus group educational sessions.
Proportion of heavily marketed hypnotics prescribed before and after the implementation of computerized alerts and educational sessions.
Main Results
The activation of computerized alerts held the prescribing of heavily marketed hypnotic medications at pre-intervention levels in both the alert-only group (adjusted risk ratio [RR] 0.97; 95% CI 0.82–1.14) and the alert-plus-education group (RR 0.98; 95% CI 0.83–1.17) while the usual-care group experienced an increase in prescribing (RR 1.31; 95% CI 1.08–1.60). Compared to the usual-care group, the relative risk of prescribing heavily marketed medications was less in both the alert-group (Ratio of risk ratios [RRR] 0.74; 95% CI 0.57–0.96) and the alert-plus-education group (RRR 0.74; 95% CI 0.58–0.97). The prescribing of heavily marketed medications was similar in the alert-group and alert-plus-education group (RRR 1.02; 95% CI 0.80–1.29). Most clinicians reported that the alerts provided useful prescribing information (88%) and did not interfere with daily workflow (70%).
Computerized decision support is an effective tool to reduce the prescribing of heavily marketed hypnotic medications in ambulatory care settings.
Trial Registration Identifier: NCT00788346.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-009-1013-x) contains supplementary material, which is available to authorized users.
PMCID: PMC2710467  PMID: 19475459
prescription drugs; effectiveness; marketed medications; prescribing; decision support; computerized alerts

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