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1.  Potential Savings Associated with Drug Substitution in Medicare Part D: The Translating Research into Action for Diabetes (TRIAD) Study 
Drug substitution is a promising approach to reducing medication costs.
To calculate the potential savings in a Medicare Part D plan from generic or therapeutic substitution for commonly prescribed drugs.
Cross-sectional, simulation analysis.
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.
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.
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.
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.
PMCID: PMC3889972  PMID: 23975059
pharmacoeconomics; Medicare; health care policy
2.  Patterns of prescription drug expenditures and medication adherence among medicare part D beneficiaries with and without the low-income supplement 
The association between the Medicare Part D low-income subsidy (LIS), gap coverage, and outcomes such as medical expenditures, prescription fills, and medication adherence is not well understood. The purpose of this study was to examine the relationship between the LIS and these measures for patients within a large, national Part D plan in the United States.
In this cross-sectional, retrospective analysis, we compared total and plan expenditures, out-of-pocket costs, and medication fills and adherence for three categories of Medicare beneficiaries: non-LIS beneficiaries without gap coverage (non-LIS/non-GC), non-LIS beneficiaries with gap coverage (non-LIS/GC), and LIS beneficiaries (LIS).
LIS beneficiaries, relative to non-LIS/non-GC and non-LIS/GC beneficiaries, had higher total expenditures ($1,887 vs. $1,360 vs. $1,341); lower out-of-pocket costs ($148 vs. $546 vs. $570); more expenditures exceeding the gap threshold (27.6% vs. 18.4% vs. 16.9%); and slightly higher adherence to blood pressure (65.6% vs. 64.2% vs. 62.4%); diabetes (62.5% vs. 57.7 vs. 57.4%); and lipid-lowering (59.6% vs. 57.0 vs. 55.6%) medications.
LIS beneficiaries had higher total expenditures, lower out-of-pocket costs, and modestly better adherence to diabetes medications than non-LIS/non-GC and non-LIS/GC beneficiaries.
PMCID: PMC4302141  PMID: 25526892
Medicare Part D; Low-income subsidy; Gap coverage; Health care expenditures; Adherence to medications
3.  Evaluation of the Diabetes Health Plan to Improve Diabetes Care and Prevention 
Investigators from the University of California, Los Angeles (UCLA), and members of the leadership and data analysis teams at UnitedHealthcare (UHC) are partnering to evaluate the Diabetes Health Plan (DHP), an innovative disease-specific insurance product designed by UHC specifically for patients with prediabetes or diabetes. The DHP provides improved access to care management, telephone coaching, and enhanced Internet-based communication with enrollees. The evaluation will use a quasi-experimental design, comparing patients from employer groups that offer the DHP with patients from groups that do not, to determine the effect of the DHP on incidence of diabetes, adherence to metformin, and costs of care among patients with prediabetes. Other factors studied will be cardiovascular risk factor control, adherence to preventive services, health care use, and costs of care among patients with existing diabetes.
PMCID: PMC3562175  PMID: 23369769
4.  Drug Benefit Changes Under Medicare Advantage Part D: Heterogeneous Effects on Pharmaceutical Use and Expenditures 
Journal of General Internal Medicine  2011;26(10):1195-1200.
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.
To examine changes in prescription drug utilization and expenditures associated with drug benefit changes resulting from the implementation of Part D.
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.
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.
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.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-011-1766-x) contains supplementary material, which is available to authorized users.
PMCID: PMC3181315  PMID: 21710313
medicare part D; benefit design; drug and medical expenditures
5.  Falling into the Coverage Gap: Part D Drug Costs and Adherence for Medicare Advantage Prescription Drug Plan Beneficiaries with Diabetes 
Health Services Research  2010;45(2):355-375.
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.
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.
PMCID: PMC2838150  PMID: 20050931
Medicare; prescription drugs; diabetes
6.  Generic-only Drug Coverage in the Medicare Part D Gap and Effect on Medication Cost-Cutting Behaviors for Patients with Diabetes: The Translating Research into Action for Diabetes (TRIAD) Study 
Medicare Part D beneficiaries with diabetes are at risk of medication non-adherence and forgoing necessities due to cost pressures. Generic drug coverage during the Part D gap may attenuate these potentially adverse behaviors.
To examine the association between drug coverage during the gap and medication cost-cutting behaviors among insulin users and non-users.
Participants and Setting
2007 survey of Medicare Advantage Part D (MAPD) and Prescription Drug Plan (PDP) beneficiaries within a network-model health system who entered the gap by October 2006 (N=1,468, 57% response rate).
The study was cross-sectional.
The primary predictor variable was no gap coverage versus generic-only gap coverage. We examined seven cost-cutting behaviors as dependent variables, including cost-related non-adherence (CRN) to any medication. Covariates included race/ethnicity, education, health status, income, and comorbidities, as well as generic medication use in the first quarter. We constructed logistic regression models using non-response weights, to generate predicted percentages.
In multivariate analyses, beneficiaries taking insulin were less likely to report CRN if they had generic-only gap coverage compared to no gap coverage (16% vs. 29%, p=0.03). No differences in CRN by type of gap coverage were seen among beneficiaries not taking insulin.
Medicare beneficiaries using insulin are at high risk of CRN. Generic-only coverage during the gap is associated with an attenuated risk of CRN among insulin users, possibly due to 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.
PMCID: PMC3125132  PMID: 20406312
Medicare Part D; pharmaceutical use; diabetes
7.  Sex differences in the relationship between maternal negative life events and children’s laboratory pain responsivity 
Prior research has demonstrated links between psychosocial factors, including negative life events (NLE) and pain in children. The present study examined sex differences in the relationship between mother-reported NLE, child NLE, mother somatization and children’s laboratory pain responses for heat, cold and pressure pain tasks. We predicted that maternal NLE would be moderately associated with girls’ pain responses, but would not be associated with boys’ pain responses.
Participants were 176 non-clinical children (89 boys) aged 8–18 years (mean = 12.2, SD = 2.7) and their mothers. Mothers and children completed questionnaires assessing their perceptions of NLE experienced in the previous 12 months.
Contrary to predictions, maternal NLE were related to pain responses in both boys and girls, although in opposite directions. Thus, increased maternal stress was associated with increased pain responses in girls but with decreased pain responses in boys. In addition, the impact of maternal NLE was only apparent for heat and pain tasks, indicating differential effects for various types of pain.
The current findings underscore the importance of family variables in understanding sex differences in children’s pain. Future research is needed to examine the mechanisms within the parent-child relationship that contribute to sex-differentiated pain outcomes, particularly under conditions of exacerbated parental stress.
PMCID: PMC2813770  PMID: 19668092
negative life events; children’s laboratory pain; sex differences
8.  Entering and Exiting the Medicare Part D Coverage Gap: Role of Comorbidities and Demographics 
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.
To examine comorbidities and demographic characteristics associated with gap entry and exit.
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.
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.
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.
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.
PMCID: PMC2869422  PMID: 20217267
medicare; health insurance; health care costs; health services research; health economics
9.  The Medicare Part D Coverage Gap and Diabetes Beneficiaries 
Patients with chronic illnesses are particularly vulnerable to drug coverage gaps. We examined drug costs and entry and exit rates into the Part D coverage gap for beneficiaries with diabetes in two large California Medicare Advantage managed care plans.
Study Design
Cross-sectional observational study.
Medicare Advantage Part D beneficiaries with diabetes from two large California health plans who were continuously enrolled in 2006 and had a drug coverage gap starting at $2,250. Entry and exit into the gap, total drug costs, and out-of-pocket drug costs were determined using pharmacy databases.
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 $2,182 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.
Fewer diabetes patients in this study entered the coverage gap than had been previously estimated, but 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 higher use of generics in managed care, or potentially signal lower drug adherence. Future work should examine these hypotheses and explore risk factors for entering the Part D coverage gap.
PMCID: PMC2824425  PMID: 19298100
Medicare Part D; diabetes; coverage gap
10.  Parent and child anxiety sensitivity: Relationship to children’s experimental pain responsivity 
Anxiety sensitivity (AS) or fear of anxiety sensations has been linked to childhood learning history for somatic symptoms, suggesting that parental AS may impact children’s responses to pain. Using structural equation modeling (SEM), we tested a conceptual model in which parent AS predicted child AS, which in turn predicted a hypothesized latent construct consisting of children’s pain intensity ratings for three laboratory pain tasks (cold pressor, thermal heat and pressure). This conceptual model was tested in 211 non-clinical parent-child pairs (104 girls, mean age = 12.4 years; 178 mothers). Our model was supported in girls only indicating that the sex of the child moderated the hypothesized relationships. Thus, parent AS was related to child laboratory pain intensity via its contribution to child AS in girls but not in boys. In girls, 42% of the effect of parent AS on laboratory pain intensity was explained via child AS. In boys, there was no clear link between parent AS and child AS, although child AS was predictive of experimental pain intensity across sex. Our results are consistent with the notion that parent AS may operate via healthy girls’ own fear of anxiety symptoms to influence their responses to laboratory pain stimuli.
Perspective-The present study highlights sex differences in the links among parent and child anxiety sensitivity (AS; fear of anxiety sensations) and children’s experimental pain responses. Among girls, childhood learning history related to somatic symptoms may be a particularly salient factor in the development of AS and pain responsivity.
PMCID: PMC1540407  PMID: 16632321
anxiety sensitivity; laboratory pain; children; adolescents; parent; sex differences

Results 1-10 (10)