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BACKGROUND: The Diabetes Health Plan (DHP), a value-based insurance plan that reduces cost sharing, was previously shown to modestly increase employer-level medication adherence. It is unclear how the DHP might impact individuals with different incomes. OBJECTIVE: To examine the impact of the DHP on individual-level medication adherence, by income level. METHODS: This is a retrospective, quasiexperimental study. An employer-level propensity score match was done to identify suitable control employers, followed by individual-level propensity score weighing. These weights were applied to difference-in-difference models examining the effect of the DHP and the effect of income on changes in adherence to metformin, statins, and angiotensin-converting enzymes/angiotensin receptor blockers. The weights were then applied to a differences-in-differences-in-differences model to estimate the differential impact of DHP status on changes in adherence by income group. RESULTS: The study population included 2,065 beneficiaries with DHP and 17,704 matched controls. There were no significant differences in changes to adherence for any medications between beneficiaries enrolled in the DHP vs standard plans. However, adherence to all medications was higher among those with incomes greater than $75,000 (year 1: metformin: +7.3 percentage points; statin +4.3 percentage points; angiotensin-converting enzymes/angiotensin receptor blockers: +6.2 percentage points; P < 0.01) compared with those with incomes less than $50,000. The differences-in-differences-in-differences term examining the impact of income on the DHP effect was not significant for any comparisons. CONCLUSIONS: We did not find significant associations between the DHP and changes in individual-level medication adherence, even for low-income beneficiaries. New strategies to improve consumer engagement may be needed to translate value-based insurance designs into changes in patient behavior. DISCLOSURES: Drs Ettner and Moin received grants from the Centers for Disease Control and Prevention and National Institute of Diabetes and Digestive and Kidney Diseases (Principal Investigator: Carol Mangione). Mr Luchs received support for attending meetings and/or travel (minimal-mileage and hotel on 2 occasions). Mr Chan has an employee benefit to purchase stock for UnitedHealth Group.

Background: Reducing patient cost-sharing and engaging patients in disease management activities have been shown to increase uptake of evidence-based care., Objective: To evaluate the effect of employer purchase of a disease-specific plan with reduced cost-sharing and disease management (the Diabetes Health Plan/DHP) on medication adherence among eligible employees and dependents., Design: Employer-level "intent to treat" cohort study, including data from eligible employees and their dependents with diabetes, regardless of whether they were enrolled in the DHP., Setting: Employers that contracted with a large national health plan administrator in 2009, 2010, and/or 2011., Participants: Ten employers that purchased the DHP and 191 employers that did not (controls). Inverse probability weighting (IPW) estimation was used to adjust for inter-group differences., Intervention: The DHP includes free or low-cost medications and physician visits. Enrollment strategies and specific benefit designs are determined by the employer and vary in practice. DHP participants are notified up front that they must engage in their own health care (e.g., receiving diabetes-related screening) in order to remain enrolled., Main Outcome Measure: Mean employee adherence to metformin, statins, and ACE/ARBs at the employer level at one year post-DHP implementation, as measured by the proportion of days covered (PDC)., Results: Baseline adherence to the three medications was similar across DHP and control employers, ranging from 64 to 69 %. In the first year after DHP implementation, predicted employer-level adherence for metformin (+4.9 percentage points, p = 0.017), statins (+4.8, p = 0.019), and ACE/ARBs (+4.4, p = 0.02) was higher with DHP purchase., Limitations: Non-randomized, observational study., Conclusions: The Diabetes Health Plan, an innovative health plan that combines reduced cost-sharing and disease management with an up-front requirement of enrollee participation in his or her own health care, is associated with a modest improvement in medication adherence at 12 months.

Background: Prediabetes affects 1 in 3 Americans. Both intensive lifestyle intervention and metformin can prevent or delay progression to diabetes. Over the past decade, lifestyle interventions have been translated across various settings, but little is known about the translation of evidence surrounding metformin use., Objective: To examine metformin prescription for diabetes prevention and patient characteristics that may affect metformin prescription., Design: Retrospective cohort analysis over a 3-year period., Setting: Employer groups that purchased health plans from the nation's largest private insurer., Participants: A national sample of 17 352 working-age adults with prediabetes insured for 3 continuous years between 2010 and 2012., Measurements: Percentage of health plan enrollees with prediabetes who were prescribed metformin., Results: Only 3.7% of patients with prediabetes were prescribed metformin over the 3-year study window. After adjustment for age, income, and education, the predicted probability of metformin prescription was almost 2 times higher among women and obese patients and more than 1.5 times higher among patients with 2 or more comorbid conditions., Limitation: Missing data on lifestyle interventions, possible misclassification of prediabetes and metformin use, and inability to define eligible patients exactly as defined in the American Diabetes Association guidelines., Conclusion: Evidence shows that metformin is rarely prescribed for diabetes prevention in working-age adults. Future studies are needed to understand potential barriers to wider adoption of this safe, tolerable, evidence-based, and cost-effective prediabetes therapy., Primary Funding Source: Centers for Disease Control and Prevention (Division of Diabetes Translation) and the National Institute of Diabetes and Digestive and Kidney Diseases.

Study Objective: To determine the association between enrollment in the Medicare Part D low-income subsidy (LIS) program, which reduces out-of-pocket medication costs, and fill adherence to the antiplatelet drug clopidogrel after coronary stent placement., Design: Retrospective cohort study., Data Source: Pharmacy claims database of a large national Medicare Part D insurer., Patients: We selected a total of 2967 beneficiaries of a national Medicare Part D plan who had a coronary stent placed between April and December 2006 and were prescribed clopidogrel but were not preexisting users of clopidogrel. Of these patients, 504 were enrolled in the LIS program and 2463 were not., Measurements and Main Results: We defined LIS status as enrollment in the LIS program at any point during the 12 months after the procedure. We examined the association between LIS status and good medication fill adherence to clopidogrel, defined as proportion of days covered of 80% or more, or discontinuation of clopidogrel over the 12-month window starting from the date of their stent placement. We also identified patients with claims-based diagnoses of major bleeding events while taking clopidogrel. For those patients, we calculated fill adherence only for the period between medication initiation and the onset of major bleeding and/or did not classify them as having inappropriately discontinued the medication. We created a propensity score predicting the propensity of being eligible for the LIS benefit and used inverse propensity score weighting with regression adjustment to generate estimates of the effect parameters. LIS enrollment was associated with a higher predicted likelihood of good clopidogrel fill adherence after stent placement (54.8% for LIS enrollees vs 47.6% for non enrollees; p=0.008). No significant difference was noted between the two groups in predicted risk of discontinuing clopidogrel after stent placement (18.3% for LIS enrollees vs 21.0% for non enrollees; p=0.21)., Conclusion: The LIS benefit was associated with better clopidogrel fill adherence after stent placement. Although clopidogrel is now available in generic form, our work underscores the need for efforts to identify and enroll patients in the LIS benefit who require costly antiplatelet medications for coronary heart disease., (© 2014 Pharmacotherapy Publications, Inc.)

Background: Drug substitution is a promising approach to reducing medication costs., Objective: To calculate the potential savings in a Medicare Part D plan from generic or therapeutic substitution for commonly prescribed drugs., Design: Cross-sectional, simulation analysis., Participants: Low-income subsidy (LIS) beneficiaries (n = 145,056) and non low-income subsidy (non-LIS) beneficiaries (n = 1,040,030) enrolled in a large, national Part D health insurer in 2007 and eligible for a possible substitution., Measurements: Using administrative data from 2007, we identified claims filled for brand-name drugs for which a direct generic substitute was available. We also identified the 50 highest cost drugs separately for LIS and non-LIS beneficiaries, and reached consensus on which drugs had possible therapeutic substitutes (27 for LIS, 30 for non-LIS). For each possible substitution, we used average daily costs of the original and substitute drugs to calculate the potential out-of-pocket savings, health plan savings, and when applicable, savings for the government/LIS subsidy., Results: Overall, 39 % of LIS beneficiaries and 51 % of non-LIS beneficiaries were eligible for a generic and/or therapeutic substitution. Generic substitutions resulted in an average annual savings of $160 in the case of LIS beneficiaries and $127 in the case of non-LIS beneficiaries. Therapeutic substitutions resulted in an average annual savings of $452 in the case of LIS beneficiaries and $389 in the case of non-LIS beneficiaries., Conclusions: Our findings indicate that drug substitution, particularly therapeutic substitution, could result in significant cost savings. There is a need for additional studies evaluating the acceptability of therapeutic substitution interventions within Medicare Part D.

Background: Although Medicare Part D improved drug benefits for many beneficiaries, its impact on the coverage of Medicare Advantage Part D (MAPD) enrollees depended on their pre-existing benefits and whether they had gap coverage under Part D., Objective: To examine changes in prescription drug utilization and expenditures associated with drug benefit changes resulting from the implementation of Part D., Patients: We studied 248,773 continuously enrolled MAPD patients in eight states. Patients whose insurance product or Census block could not be identified or who had atypical benefits, low-income subsidies or Medicaid coverage were excluded., Main Measures: The main outcomes were changes in prescription drug days supply and expenditures from 2005 to 2006 and 2005 to 2007., Design: We linked Census data with 2005-7 MAPD claims, encounter, enrollment, and benefits data and estimated associations of the outcomes with changes in drug benefits, controlling for 2005 comorbidities, demographics, and Census population characteristics., Key Results: MAPD enrollees whose drug benefits became potentially less generous after Part D had the smallest increases in drug utilization and expenditures (e.g., drug expenditures increased by $130 between 2005 and 2006), while those who potentially gained the most from Part D experienced the largest increases ($302). The differences in benefit design changes had a stronger association with drug utilization and outcomes among patients at high risk of gap entry than among the entire sample., Conclusions: Although Medicare Part D unambiguously improved drug coverage for many elderly, it led to heterogeneous changes in drug benefits among MAPD enrollees, who already had generic and sometimes branded drug benefits. After 2006, benefits were worse for individuals who had branded drug coverage in 2005 but now had a coverage gap, but benefits may have improved for individuals who acquired branded drug coverage. Commensurate with these differential changes in benefits following Part D, changes in drug utilization and expenditures varied substantially as well.

Background: Some Medicare Part D enrollees whose drug expenditures exceed a threshold enter a coverage gap with full cost-sharing, increasing their risk for reduced adherence and adverse outcomes., Objective: To examine comorbidities and demographic characteristics associated with gap entry and exit., Design: We linked 2005-2006 pharmacy, outpatient, and inpatient claims to enrollment and Census data. We used logistic regression to estimate associations of 2006 gap entry and exit with 2005 medical comorbidities, demographics, and Census block characteristics. We expressed all results as predicted percentages., Patients: 287,713 patients without gap coverage, continuously enrolled in a Medicare Advantage Part D (MAPD) plan serving eight states. Patients who received a low-income subsidy, could not be geocoded, or had no 2006 drug fills were excluded., Results: Of enrollees, 15.9% entered the gap, 2.6% within the first 180 days; among gap enterers, only 6.7% exited again. Gap entry was significantly associated with female gender and all comorbidities, particularly dementia (39.5% gap entry rate) and diabetes (28.0%). Among dementia patients entering the gap, anti-dementia drugs (donepezil, memantine, rivastigmine, and galantamine) and atypical antipsychotic medications (risperidone, quetiapine, and olanzapine) together accounted for 40% of pre-gap expenditures. Among diabetic patients, rosiglitazone accounted for 7.2% of pre-gap expenditures. Having dementia was associated with twice the risk of gap exit., Conclusions: Certain chronically ill MAPD enrollees are at high risk of gap entry and exposure to unsubsidized medication costs. Clinically vulnerable populations should be counseled on how to best manage costs through drug substitution or discontinuation of specific, non-essential medications.

Objectives: To examine the association between drug coverage during the Medicare Part D coverage gap and medication cost-cutting behaviors of beneficiaries with diabetes mellitus who use and do not use insulin., Design: The study was cross-sectional., Setting: A network-model health system., Participants: 2007 survey of Medicare Advantage Part D (MAPD) and Prescription Drug Plan (PDP) beneficiaries who entered the gap by October 2006 (N=1,468, 57% response rate)., Measurements: The primary predictor variable was no gap coverage versus generic-only gap coverage. Seven cost-cutting behaviors were examined as dependent variables, including cost-related nonadherence (CRN) to any medication. Covariates included race or ethnicity, education, health status, income, and comorbidities, as well as generic medication use in the first quarter. Logistic regression models were constructed using nonresponse weights to generate predicted percentages., Results: In multivariate analyses, beneficiaries taking insulin were less likely to report CRN if they had generic-only gap coverage than if they had no gap coverage (16% vs 29%, P=.03). No differences in CRN according to type of gap coverage were seen between beneficiaries not taking insulin., Conclusion: Medicare beneficiaries using insulin are at high risk of CRN. Generic-only coverage during the gap is associated with an attenuated risk of CRN in insulin users, possibly because of savings on other, generic medications. Future research should evaluate CRN within alternative benefit designs covering selected brand name medications, such as insulin, during the gap.

Objective: To compare drug costs and adherence among Medicare beneficiaries with the standard Part D coverage gap versus supplemental gap coverage in 2006., Data Sources: Pharmacy data from Medicare Advantage Prescription Drug (MAPD) plans., Study Design: Parallel analyses comparing beneficiaries aged 65+ with diabetes in an integrated MAPD with a gap versus no gap (n=28,780); and in a network-model MAPD with a gap versus generic-only coverage during the gap (n=14,984)., Principal Findings: Drug spending was 3 percent (95 percent confidence interval [CI]: 1-4 percent) and 4 percent (CI: 1-6 percent) lower among beneficiaries with a gap versus full or generic-only gap coverage, respectively. Out-of-pocket expenditures were 189 percent higher (CI: 185-193 percent) and adherence to three chronic drug classes was lower among those with a gap versus no gap (e.g., odds ratio=0.83, CI: 0.79-0.88, for oral diabetes drugs). Annual out-of-pocket spending was 14 percent higher (CI: 10-17 percent) for beneficiaries with a gap versus generic-only gap coverage, but levels of adherence were similar., Conclusions: Among Medicare beneficiaries with diabetes, having the Part D coverage gap resulted in lower total drug costs, but higher out-of-pocket spending and worse adherence compared with having no gap. Having generic-only coverage during the gap appeared to confer limited benefits compared with having no gap coverage.

Objective: To examine drug costs and entry and exit rates into the Part D coverage gap for beneficiaries with diabetes in Medicare Advantage managed care plans., Study Design: Cross-sectional observational study., Methods: Study patients were Medicare Advantage Part D beneficiaries with diabetes from 2 large California health plans who were continuously enrolled in 2006 and had a drug coverage gap starting at $2250. Entry and exit into the gap, total drug costs, and out-of-pocket drug costs were determined using pharmacy databases., Results: In 2006, 26% of the 42,801 beneficiaries with diabetes reached the coverage gap; 2% of beneficiaries exited the gap and qualified for catastrophic coverage. Beneficiaries incurred a mean of $2182 in total drug costs during 2006. Drug expenditures remained stable over the year for beneficiaries who did not enter the gap. For beneficiaries who entered the gap, total drug costs were higher overall and decreased at year's end as out-of-pocket expenses increased., Conclusions: Fewer diabetes patients in this study entered the coverage gap than had been previously estimated, but the entry rate was much higher than that of the general Medicare Advantage Part D population. Patients entering the gap had lower subsequent monthly drug expenditures; this may be due to lower-than-expected drug prices and greater use of generics in managed care, or it may potentially signal poorer drug adherence. Future work should examine these hypotheses and explore risk factors for entering the Part D coverage gap.