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1.  Cholinesterase Inhibitor and Memantine Use in Newly Admitted Nursing Home Residents with Dementia 
To quantify the use of cholinesterase inhibitors (ChEIs) and memantine in nursing home (NH) residents with dementia upon NH admission and 3 months later and to examine factors associated with reduction in therapy.
Retrospective cohort study.
Nationwide sample of U.S. NHs.
Three thousand five hundred six NH residents with dementia newly admitted in 2006.
Data from pharmacy dispensing records were used to determine ChEI and memantine medication use upon NH admission and at 3-month follow-up. The Minimum Data Set was used to determine resident- and facility-level characteristics. Severity of dementia was defined using the Cognitive Performance Scale (CPS).
Overall, 40.1% (n =1,407) of newly admitted NH residents with dementia received ChEIs and memantine on NH admission. Use of ChEIs and memantine on admission was significantly greater in residents with mild to moderately severe dementia (41.2%) than in those with advanced dementia (33.3%, P =.001). After 3 months, ChEI and memantine use decreased by about half in both groups (48.6% with mild to moderately severe dementia vs 57.0% with advanced dementia, P<.05). NH residents with advanced dementia were significantly more likely reduce their use of ChEIs and memantine than those with mild to moderately severe dementia (odds ratio =1.44, 95% confidence interval =1.03–2.01, P =.04).
Many NH residents with advanced dementia receive ChEIs and memantine upon NH admission, and approximately half of these decrease their medication use over the ensuing months. Further study is required to optimize use of ChEIs and memantine in NH populations and to determine the effects of withdrawing therapy on resident outcomes.
PMCID: PMC4841243  PMID: 21668913
dementia; nursing homes; cholinesterase inhibitor; memantine
2.  Identifying Patients With Osteoporosis or at Risk for Osteoporotic Fractures 
To test the validity of using administrative data to identify patients with osteoporosis or low bone mineral density (BMD) and high risk for osteoporotic fractures.
Study Design
We conducted a retrospective cohort study.
We analyzed data from a managed care plan in Massachusetts. We developed 6 case-identification algorithms based on number of osteoporosis (OP) diagnoses, clinical setting of the OP diagnosis, timing of the OP diagnosis relative to BMD test, and clinical fracture risk factors adapted from the World Health Organization Fracture Risk Assessment Tool. We validated the algorithms against BMD results and calculated sensitivity, specificity, and positive predictive value (PPV) against 2 diagnostic criteria (T-score ≤−2.5 and T-score ≤−2.0).
When compared against the first criterion (T-score ≤−2.5), the sensitivity of algorithm (35% to 80%), specificity (65% to 93%), PPV (44% to 63%), and adding fracture risk factors did not improve case identification. When compared against the expanded criterion (T-score ≤−2.0), we found the sensitivity of the algorithms ranged from 23% to 63%, specificity from 72% to 95%, and PPV from 67% to 83%. Including fracture risk in the expanded OP criterion improved case identification, and the algorithms achieved the highest PPV: 70% to 85%.
Identifying patients with OP or low BMD and high risk for osteoporotic fractures is possible in administrative data if using information about both OP diagnoses and fracture risk profile.
PMCID: PMC4841251  PMID: 22435886
3.  Did Medicare Part D Affect National Trends in Health Outcomes or Hospitalizations? 
Annals of internal medicine  2015;162(12):825-833.
Medicare Part D increased economic access to medications, but its effect on population-level health outcomes and use of other medical services remains unclear.
To examine changes in health outcomes and medical services in the Medicare population after implementation of Part D.
Population-level longitudinal time-series analysis with generalized linear models.
Nationally representative sample of Medicare beneficiaries (n = 56 293 [unweighted and unique]) from 2000 to 2010.
Changes in self-reported health status, limitations in activities of daily living (ADLs) (ADLs and instrumental ADLs), emergency department visits and hospital admissions (prevalence, counts, and spending), and mortality. Medicare claims data were used for confirmatory analyses.
Five years after Part D implementation, no clinically or statistically significant reductions in the prevalence of fair or poor health status or limitations in ADLs or instrumental ADLs, relative to historical trends, were detected. Compared with trends before Part D, no changes in emergency department visits, hospital admissions or days, inpatient costs, or mortality after Part D were seen. Confirmatory analyses were consistent.
Only total population-level outcomes were studied. Self-reported measures may lack sensitivity.
Five years after implementation, and contrary to previous reports, no evidence was found of Part D’s effect on a range of population-level health indicators among Medicare enrollees. Further, there was no clear evidence of gains in medical care efficiencies.
PMCID: PMC4841503  PMID: 26075753
4.  Pain Management Among Nursing Home Residents with Cancer 
In the mid-1990s, 29.4% of nursing home (NH) residents with cancer suffered from daily pain, and among them 26% failed to receive any analgesics.
To assess improvements in pain management of NH residents with cancer since the implementation of pain management quality indicators.
Cross-sectional study.
1,382 US NHs.
8,094 newly-admitted, Medicare-eligible NH residents with cancer.
Nationwide data on NH resident health from the Minimum Data Set 2.0 linked to all-payer pharmacy dispensing records (February 2006–June 2007) were used to determine prevalence of pain, including frequency and intensity, and receipt of non-opioid and opioid analgesics. Multinomial logistic regression evaluated resident-level correlates of pain and binomial logistic regression identified correlates of untreated pain.
More than 65% of NH residents with cancer had any pain (28.3% daily, 37.3% less than daily), among whom 13.5% had severe and 61.3% had moderate pain. Women, residents admitted from acute care or who were bedfast, and those with compromised activities of daily living, depressed mood, indwelling catheter, or terminal prognosis were more likely to have pain. More than 17% of residents in daily pain (95% confidence interval [CI]: 16.0–19.1%) received no analgesics, including 11.7% with daily severe pain (95% CI: 8.9–14.5%) and 16.9% with daily moderate pain (95% CI: 15.1–18.8%). Treatment was negatively associated with age >85 years (adjusted odds ratio [aOR]=0.67, 95% CI: 0.55–0.81 versus aged 65–74), cognitive impairment (aOR=0.71, 95% CI: 0.61–0.82), presence of feeding tube (aOR=0.77, 95% CI: 0.60–0.99), and restraints (aOR=0.50, 95% CI: 0.31–0.82).
Untreated pain is still common among NH residents with cancer and persists despite pain management quality indicators.
PMCID: PMC4408881  PMID: 25900481
nursing home; cancer; pain; analgesics
5.  Use of Atypical Antipsychotics in Nursing Homes and Pharmaceutical Marketing 
Many nursing home (NH) residents are prescribed atypical antipsychotics despite US Food and Drug Administration warnings of increased risk of death in older adults with dementia. Aggressive pharmaceutical marketing has been cited as a potential cause, although data are scarce. The objectives of this study were to describe the current extent and type of pharmaceutical marketing in NHs in one state, and to provide preliminary evidence for the potential influence of pharmaceutical marketing on the use of atypical antipsychotics in NHs.
Nested mixed-methods, cross-sectional study of NHs in a cluster randomized trial.
41 NHs in Connecticut.
NH administrators, directors of nursing and medical directors (n = 93, response rate 75.6%).
Quantitative data, including prescription drug dispensing data (September 2009–August 2010) linked with Nursing Home Compare data (April 2011), were used to determine facility-level prevalence of atypical antipsychotic use, facility-level characteristics, NH staffing and NH quality. Qualitative data, including semi-structured interviews and surveys of NH leaders conducted in the first quarter of 2011, were used to determine encounters with pharmaceutical marketing.
Leadership at 46.3% of NHs (19/41) reported pharmaceutical marketing encounters, consisting of educational training, written/Internet-based materials and/or sponsored training. No association was detected between the level of atypical antipsychotic prescribing and reports of any pharmaceutical marketing by at least one NH leader.
NH leaders frequently encounter pharmaceutical marketing through a variety of ways, although the impact on atypical antipsychotic prescribing is unclear.
PMCID: PMC4332626  PMID: 25688605
nursing homes; pharmaceutical marketing; atypical antipsychotics
6.  Use of Medications of Questionable Benefit in Advanced Dementia 
JAMA internal medicine  2014;174(11):1763-1771.
Advanced dementia is characterized by severe cognitive impairment and complete functional dependence. Patients’ goals of care should guide the prescribing of medication during such terminal illness. Medications that do not promote the primary goal of care should be minimized.
To estimate the prevalence of medications with questionable benefit used by nursing home residents with advanced dementia, identify resident- and facility-level characteristics associated with such use, and estimate associated medication expenditures.
Cross-sectional study of medication use by nursing home residents with advanced dementia using a nationwide long-term care pharmacy database linked to the Minimum Data Set (460 facilities) between October 1, 2009, and September 30, 2010.
Use of medication deemed of questionable benefit in advanced dementia based on previously published criteria and mean 90-day expenditures attributable to these medications per resident. Generalized estimating equations using the logit link function were used to identify resident- and facility-related factors independently associated with the likelihood of receiving medications of questionable benefit after accounting for clustering within nursing homes.
Of 5406 nursing home residents with advanced dementia, 2911 (53.9%) received at least 1 medication with questionable benefit (range, 44.7% in the Mid-Atlantic census region to 65.0% in the West South Central census region). Cholinesterase inhibitors (36.4%), memantine hydrochloride (25.2%), and lipid-lowering agents (22.4%) were the most commonly prescribed. In adjusted analyses, having eating problems (adjusted odds ratio [AOR], 0.68; 95% CI, 0.59–0.78), a feeding tube (AOR, 0.58; 95% CI, 0.48–0.70), or a do-not-resuscitate order (AOR, 0.65; 95% CI, 0.57–0.75), and enrolling in hospice (AOR, 0.69; 95% CI, 0.58–0.82) lowered the likelihood of receiving these medications. High facility-level use of feeding tubes increased the likelihood of receiving these medications (AOR, 1.45; 95% CI, 1.12–1.87). The mean (SD) 90-day expenditure for medications with questionable benefit was $816 ($553), accounting for 35.2% of the total average 90-day medication expenditures for residents with advanced dementia who were prescribed these medications.
Most nursing home residents with advanced dementia receive medications with questionable benefit that incur substantial associated costs.
PMCID: PMC4689196  PMID: 25201279
7.  Persistent medication affordability problems among disabled Medicare beneficiaries after Part D, 2006–2011 
Medical care  2014;52(11):951-956.
Disabled Americans who qualify for Medicare coverage typically have multiple chronic conditions, are highly dependent on effective drug therapy, and have limited financial resources, putting them at risk for cost-related medication nonadherence (CRN). Since 2006, the Part D benefit has helped Medicare beneficiaries afford medications.
To investigate recent national trends in medication affordability among this vulnerable population, stratified by morbidity burden.
Design and Subjects
We estimated annual rates of medication affordability among nonelderly disabled participants in a nationally representative survey (2006–2011, n = 14,091 person-years) using multivariate logistic regression analyses.
Survey-reported CRN and spending less on other basic needs to afford medicines.
In the six years following Part D implementation, the proportion of disabled Medicare beneficiaries reporting CRN ranged from 31.6% to 35.6%, while the reported prevalence of spending less on other basic needs to afford medicines ranged from 17.7% to 21.8%. Across study years, those with multiple chronic conditions had consistently worse affordability problems. In 2011, the prevalence of CRN was 37.3% among disabled beneficiaries with three or more morbidities as compared to 28.1% among those with fewer morbidities; for spending less on basic needs, the prevalence was 25.4% versus 15.7%, respectively. There were no statistically detectable changes in either measure when comparing 2011 to 2007.
Disabled Medicare beneficiaries continue to struggle to afford prescription medications. There is an urgent need for focused policy attention on this vulnerable population, which has inadequate financial access to drug treatments, despite having drug coverage under Medicare Part D.
PMCID: PMC4539257  PMID: 25122530
adherence; costs; disability; drug policy; Medicare
8.  Antidepressant Use and Cognitive Decline: The Health and Retirement Study 
The American journal of medicine  2015;128(7):739-746.
Depression is associated with cognitive impairment and dementia, but whether treatment for depression with antidepressants reduces the risk for cognitive decline is unclear. We assessed the association between antidepressant use and cognitive decline over 6 years.
Participants were 3714 adults aged 50 years or more who were enrolled in the nationally representative Health and Retirement Study and had self-reported antidepressant use. Depressive symptoms were assessed using the 8-item Center for Epidemiologic Studies Depression Scale. Cognitive function was assessed at 4 time points (2004, 2006, 2008, 2010) using a validated 27-point scale. Change in cognitive function over the 6-year follow-up period was examined using linear growth models, adjusted for demographics, depressive symptoms, comorbidities, functional limitations, and antidepressant anticholinergic activity load.
At baseline, cognitive function did not differ significantly between the 445 (12.1%) participants taking antidepressants and those not taking antidepressants (mean, 14.9%; 95% confidence interval, 14.3–15.4 vs mean, 15.1%; 95% confidence interval, 14.9–15.3). During the 6-year follow up period, cognition declined in both users and nonusers of antidepressants, ranging from −1.4 change in mean score in those with high depressive symptoms and taking antidepressants to −0.5 change in mean score in those with high depressive symptoms and not taking antidepressants. In adjusted models, cognition declined in people taking antidepressants at the same rate as those not taking antidepressants. Results remained consistent across different levels of baseline cognitive function, age, and duration of antidepressant use (prolonged vs short-term).
Antidepressant use did not modify the course of 6-year cognitive change in this nationally representative sample.
PMCID: PMC4618694  PMID: 25644319
Antidepressants; Cognition; Depression; Epidemiology
9.  Gains in medication affordability following Medicare Part D are eroding among elderly with multiple chronic conditions 
Health affairs (Project Hope)  2014;33(8):1435-1443.
Elderly Americans, especially those with multiple chronic conditions, face difficulties paying for prescriptions, resulting in worse adherence and discontinuation of therapy (“cost-related medication nonadherence” or CRN). We investigated whether the gains in medication affordability attributable to Medicare Part D implementation in January 2006 persisted during the six years that followed. Overall, we found continued incremental improvements in medication affordability in the early years of Part D (2007–2009), which then eroded during more recent years (2009–2011). Among elderly beneficiaries with four or more chronic conditions, we observed an increase in the prevalence of CRN from 14.4% in 2009 to 17.0% in 2011, reversing previous downward trends. Similarly, the prevalence of forgoing basic needs in order to purchase medicines among the sickest elderly decreased from 8.7% in 2007 to 6.8% in 2009, then rose to 10.2% in 2011. Our findings highlight the need for targeted policy efforts to alleviate the persistent burden of drug treatment costs in this vulnerable population.
PMCID: PMC4340076  PMID: 25092846
10.  Antipsychotic Use in Nursing Homes Varies by Psychiatric Consultant 
Medical care  2014;52(3):267-271.
The relationship between psychiatric consultation and antipsychotic prescribing in nursing homes (NH) is unknown.
To identify the association between psychiatric consultant groups and NH-level antipsychotic prescribing after adjustment for resident case-mix and facility characteristics.
Research Design & Subjects
Nested cross-sectional study of 60 NHs in a cluster randomized trial. We linked facility leadership surveys to October 2009-September 2010 Minimum Data Set, Nursing Home Compare, U.S. Census and pharmacy dispensing data.
The main exposure is the psychiatric consultant group and the main outcome is NH-level prevalence of atypical antipsychotic use. We calculated annual means and interquartile ranges of NH-level antipsychotic use for each consultant group and arrayed consultant groups from lowest to highest prevalence. Generalized linear models were used to predict antipsychotic prescribing adjusting for resident case-mix and facility characteristics. Observed versus predicted antipsychotic prescribing levels were compared for each consultant group.
Seven (7) psychiatric consultant groups served a range of 3 to 27 study facilities. Overall mean facility-level antipsychotic prescribing was 19.2%. Mean prevalence of antipsychotic prescribing ranged from 12.2% (SD 5.8) in the lowest consultant group to 26.4% (SD 3.6) in the highest group. All facilities served by the highest-ranked consultant group had observed antipsychotic levels exceeding the overall study mean with half exceeding predictions for on-label indications, while most facilities served by the lowest-ranked consultant group had observed levels below the overall study and predicted means.
Preliminary evidence suggests that psychiatric consultant groups affect NH antipsychotic prescribing independent of resident case-mix and facility characteristics.
PMCID: PMC3948216  PMID: 24374410
antipsychotics; nursing homes; quality of care; case-mix; inappropriate drug use
11.  A Critical Review of Methods to Evaluate the Impact of FDA Regulatory Actions 
Pharmacoepidemiology and drug safety  2013;22(9):10.1002/pds.3480.
To conduct a synthesis of the literature on methods to evaluate the impacts of FDA regulatory actions, and identify best practices for future evaluations.
We searched MEDLINE for manuscripts published between January 1948 and August 2011 that included terms related to FDA, regulatory actions, and empirical evaluation; the review additionally included FDA-identified literature. We used a modified Delphi method to identify preferred methodologies. We included studies with explicit methods to address threats to validity, and identified designs and analytic methods with strong internal validity that have been applied to other policy evaluations.
We included 18 studies out of 243 abstracts and papers screened. Overall, analytic rigor in prior evaluations of FDA regulatory actions varied considerably; less than a quarter of studies (22%) included control groups. Only 56% assessed changes in the use of substitute products/services, and 11% examined patient health outcomes. Among studies meeting minimal criteria of rigor, 50% found no impact or weak/modest impacts of FDA actions and 33% detected unintended consequences. Among those studies finding significant intended effects of FDA actions, all cited the importance of intensive communication efforts. There are preferred methods with strong internal validity that have yet to be applied to evaluations of FDA regulatory actions.
Rigorous evaluations of the impact of FDA regulatory actions have been limited and infrequent. Several methods with strong internal validity are available to improve trustworthiness of future evaluations of FDA policies.
PMCID: PMC3825208  PMID: 23847020
FDA; Regulatory Actions; Evaluation Methodology
12.  The Challenge of Changing Nursing Home Prescribing Culture 
PMCID: PMC3910400  PMID: 22264855
Nursing home; prescription drugs; antipsychotics; intervention study; prescribing culture
13.  Caution in Generalizing Part D Results to Medicare Population 
Archives of internal medicine  2011;171(4):10.1001/archinternmed.2011.9.
PMCID: PMC3828644  PMID: 21357816
14.  Cost-Related Medication Nonadherence in Older Rheumatoid Arthritis Patients 
The Journal of rheumatology  2013;40(2):10.3899/jrheum.120441.
Economic access to costly medications including biologic agents can be challenging. Our objective was to examine whether patients with rheumatoid arthritis (RA) are at particular risk for cost-related medication nonadherence (CRN) and spending less on basic needs.
We identified a nationally-representative sample of older adults with RA (n=1100) in the (2004–2008) Medicare Current Beneficiary Survey and compared them to older adults with other morbidities categorized by chronic disease count: 0 (n=5,898), 1–2 (n=30,538), and ≥ 3 (n=34,837). We compared annual rates of self-reported CRN (skipping or reducing medication doses or not obtaining prescriptions due to cost) as well as spending less on basic needs to afford medications and tested for differences using survey-weighted logistic regression analyses adjusted for demographic characteristics, health status, and prescription drug coverage.
In the RA sample, the unadjusted weighted prevalence of CRN ranged from 20.7% in 2004 to 18.4% in 2008 as compared to 18.5% and 11.9% respectively in patients with 3 or more nonRA conditions. In adjusted analyses having RA was associated with a 3.5-fold increase in the risk of CRN (OR: 3.52; 95% CI: 2.63–4.71) and almost 2.5-fold risk of spending less on basic needs (OR: 2.41; 95% CI 1.78–3.25) as compared to those without a chronic condition.
Patients with RA experience a high prevalence of CRN and forgoing basic needs that is greater than that of older adults with multiple chronic conditions and did not improve during a period of policy change aimed at alleviating high drug costs.
PMCID: PMC3815617  PMID: 23322458
rheumatoid arthritis; biologics; disease modifying anti-rheumatic drugs; costs; adherence
15.  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
17.  Time Trends in Medication Use and Expenditures in Older Rheumatoid Arthritis Patients 
The American journal of medicine  2012;125(9):937.e9-937.e15.
We sought to examine how expansions in insurance coverage of nonbiologic and biologic disease modifying anti-rheumatic drugs (DMARDs) impacted the access, costs and health status of older patients with rheumatoid arthritis.
We identified a nationally-representative sample of older adults with rheumatoid arthritis in the 2000–2006 Medicare Current Beneficiary Survey (unweighted n=1051). We examined changes in DMARD use, self-reported health status, functional status (activities of daily living [ADL]), and total costs and out-of-pocket costs for medical care and prescription drugs. Tests for time trends were conducted using weighted regressions.
Between 2000 and 2006, the proportion of older adults with rheumatoid arthritis who received biologics tripled (4.6% vs. 13.2%, p=0.01), while the proportion of people that used a nonbiologic did not change. During the same period, the proportion of older rheumatoid arthritis patients rating their health as excellent/good significantly increased (43.0% in 2000 to 55.6% in 2006; p=0.015). Significant improvements occurred in activities of daily living measures of functional status. Total prescription drug costs (in 2006 US dollars) increased from $2645 in 2000 to $4685 in 2006, p=0.0001, while out-of-pocket prescription costs remained constant ($842 in 2000 vs. $832 in 2006; p=0.68). Total medical costs did not significantly increase ($16563 in 2000 vs. $19510 in 2006; p=0.07).
Receipt of biologics in older adults with rheumatoid arthritis increased over a period of time where insurance coverage was expanded without increasing patients’ out-of-pocket costs. During this time period concurrent improvements in self-reported health status and functional status suggest improved arthritis care.
PMCID: PMC3432666  PMID: 22682794
Rheumatoid Arthritis; Disease Modifying Anti-Rheumatic Drugs (DMARD); Biologic Response Modifiers; Medication; Costs
18.  Medicare Part D and Quality of Prescription Medication Use 
Drugs & aging  2011;28(10):797-807.
In 2006, the United States Centers for Medicare and Medicaid Services implemented Medicare Part D to provide outpatient prescription drug insurance to disabled and older adults. In creating Part D, a key provision to address quality included medication therapy management (MTM) programs designed to increase proper and safe use of medications among targeted Part D beneficiaries. A preponderance of evidence shows that Part D has increased medication affordability and accessibility; however, what remains less clear is whether it has improved the quality of medication use and optimized health outcomes. Now in its sixth year, Part D is undergoing its first major revision with the gradual elimination of the coverage gap by 2020. Therefore, now is a good time to review the accumulated evidence on the impact of Part D and MTM programs on quality of medication use to help inform future policy decisions and research directions. In this review, we find that Part D’s net effect on quality of medication use mainly has been positive. Cost-related medication nonadherence improves moderately and treatment interruptions happen less than expected. However, vulnerable subgroups, such as sicker and dual-eligible beneficiaries, experienced lags in improvement. Beneficiaries who entered the coverage gap consistently experienced interruptions and displayed worsening medication adherence after entering the gap, with generic-only gap drug coverage offering only suggested limited benefit. Such findings can serve as baseline information as the coverage gap phases out. Limited availability of data is the biggest barrier to research in Part D. Part D’s overall effect on health outcomes and adverse medical events, such as hospitalizations, is inconclusive because of inadequate evidence to date. Similarly, no evaluation of quality of medication use is available on utilization management strategies and MTM programs delivered under Part D. Future research will need to further examine the added value of Part D and address whether it optimizes health outcomes in the Medicare population. As the current economic recession increases the pressure to cut costs, the effect of future spending restrictions, such as restrictions on coverage subsidies, will also be of special concern.
PMCID: PMC3298545  PMID: 21970307
19.  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
20.  Use of Instrumental Variable in Prescription Drug Research with Observational Data: A Systematic Review 
Journal of clinical epidemiology  2010;64(6):687-700.
Instrumental variable (IV) analysis may offer a useful approach to the problem of unmeasured confounding in prescription drug research if the IV is: 1) strongly and unbiasedly associated to treatment assignment; and 2) uncorrelated with factors predicting the outcome (key assumptions).
Study Design and Methods
We conducted a systematic review of the use of IV methods in prescription drug research to identify the major types of IVs and the evidence for meeting IV assumptions. We searched MEDLINE, OVID, PsychoInfo, Econlit and economic databases from 1961 to 2009.
We identified 26 studies. Most (n=16) were published after 2007. We identified five types of IVs: regional variation (n=8), facility prescribing patterns (n=5), physician preference (n=8), patient history/financial status (n=3) and calendar time (n=4). Evidence supporting the validity of IV was inconsistent. All studies addressed the first IV assumption; however, there was no standard for demonstrating that the IV sufficiently predicted treatment assignment. For the second assumption, 23 studies provided explicit argument that IV was uncorrelated with the outcome, and 16 supported argument with empirical evidence.
Use of IV methods is increasing in prescription drug research. However, we did not find evidence of a dominant IV. Future research should develop standards for reporting the validity and strength of IV according to key assumptions.
PMCID: PMC3079803  PMID: 21163621
21.  Self-reported colorectal cancer screening of Medicare beneficiaries in family medicine vs. internal medicine practices in the United States: a cross-sectional study 
BMC Gastroenterology  2012;12:23.
The benefit of screening for decreasing the risk of death from colorectal cancer (CRC) has been shown, yet many patients in primary care are still not undergoing screening according to guidelines. There are known variations in delivery of preventive health care services among primary care physicians. This study compared self-reported CRC screening rates and patient awareness of the need for CRC screening of patients receiving care from family medicine (FPs) vs. internal medicine (internists) physicians.
Nationally representative sample of non-institutionalized beneficiaries who received medical care from FPs or internists in 2006 (using Medicare Current Beneficiary Survey). The main outcome was the percentage of patients screened in 2007. We also examined the percentage of patients offered screening.
Patients of FPs, compared to those of internists, were less likely to have received an FOBT kit or undergone home FOBT, even after accounting for patients' characteristics. Compared to internists, FPs' patients were more likely to have heard of colonoscopy, but were less likely to receive a screening colonoscopy recommendation (18% vs. 27%), or undergo a colonoscopy (43% vs. 46%, adjusted odds ratios [AOR], 95% confidence interval [CI]-- 0.65, 0.51-0.81) or any CRC screening (52% vs. 60%, AOR, CI--0.80, 0.68-0.94). Among subgroups examined, higher income beneficiaries receiving care from internists had the highest screening rate (68%), while disabled beneficiaries receiving care from FPs had the lowest screening rate (34%).
Patients cared for by FPs had a lower rate of screening compared to those cared for by internists, despite equal or higher levels of awareness; a difference that remained statistically significant after accounting for socioeconomic status and access to healthcare. Both groups of patients remained below the national goal of 70 percent.
PMCID: PMC3352176  PMID: 22436107
Colorectal cancer screening; Primary care physicians; Colonoscopy; Fecal occult blood test
22.  Methodological Issues in Using Multiple Years of the Medicare Current Beneficiary Survey 
Medicare & Medicaid Research Review  2012;2(1):002.01.a04.
The analysis presented in this paper examines the multi-year capacity of the Medicare Current Beneficiary Survey (MCBS).
We systematically reviewed the literature for methodological approaches in research using multiple years of the MCBS and categorized the studies by study design, use of survey sampling weights, and variance adjustments. We then replicated the approaches in an empirical demonstration using functional status (activities of daily living (ADL) and 2005-2007 MCBS data.
In the systematic review, we identified 22 pooled, 17 repeated cross-sectional, and 17 longitudinal studies. Less than half of these studies explicitly described the weighting approach or variance estimation. In the empirical demonstration, we showed that different study designs and weighting approaches will yield statistically different estimates.
There is a variety of methodological approaches when using multiple years of the MCBS, and some of them provide biased results. Research needs to improve in describing the methods and preferred approaches for using these complex data.
PMCID: PMC4006385  PMID: 24800135
Medicare current beneficiary survey; Health Care Surveys; Survey design; Survey sampling weight; Systematic review; SAS; SUDAAN
23.  Adherence and Occurrence of Fractures after Switching to Once-Monthly Oral Bisphophonates 
Pharmacoepidemiology and drug safety  2010;19(12):1233-1240.
Reducing dosing demands of medications generally increases adherence, although this relationship has not been demonstrated with the once-monthly oral bisphosphonates (BP). The study aim is to test whether switching from once-weekly BPs to once-monthly BPs improves adherence and fracture risk.
This is an interrupted times-series analysis of new users of once-weekly BPs in a nationwide administrative health database from 2003–2007. Participants include 1835 individuals who switched to once-monthly BPs and two propensity-matched comparator groups: 1835 individuals who switched to a different once-weekly BP, and 1835 who did not switch. We measured changes in adequate adherence pre- and post-switch as monthly medication possession ratio >0.80, and calculated incidence rate ratios [IRR] of osteoporotic fractures.
All study groups experienced major adherence failure in the first year of therapy: the proportion of adequate adherers was 42% among once-monthly switchers, 47% among once-weekly switchers, and 37% among nonswitchers. However, the once-monthly switch was associated with less adherence failure (4% fewer adherers per month pre-switch vs. 1% fewer adherers per month post-switch, p<.000). There was no statistically significant change in adherence rates for the other groups. We did not detect significantly reduced fracture risk with once-monthly switch: 1 year post-switch, the fracture incidence risk ratios for once-monthly switchers relative to once-weekly switchers were IRR 0.83, 95% CI: 0.50–1.36, and IRR 0.90, 95% CI: 0.54–1.49, relative to nonswitchers).
Reducing the dosing demands of oral bisphosphonates from once-weekly to once-monthly decreased adherence failure but had an uncertain impact on fracture risk.
PMCID: PMC3079953  PMID: 21108489
patient compliance; bisphosphonates; osteoporosis; osteoporotic fractures; medication adherence
24.  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
25.  Can Pay-for-Performance Take Nursing Home Care to the Next Level? 
PMCID: PMC3089058  PMID: 18771454

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