Use of menopausal hormone therapy beyond age 65 years and its effects on women's health outcomes by types, routes, and doses.

OBJECTIVES: The study aims to assess the use of menopausal hormone therapy beyond age 65 years and its health implications by types of estrogen/progestogen, routes of administration, and dose strengths. METHODS: Using prescription drug and encounter records of 10 million senior Medicare women from 2007-2020 and Cox regression analyses adjusted for time-varying characteristics of the women, we examined the effects of different preparations of menopausal hormone therapy on all-cause mortality, five cancers, six cardiovascular diseases, and dementia. RESULTS: Compared with never use or discontinuation of menopausal hormone therapy after age 65 years, the use of estrogen monotherapy beyond age 65 years was associated with significant risk reductions in mortality (19% or adjusted hazards ratio, 0.81; 95% CI, 0.79-0.82), breast cancer (16%), lung cancer (13%), colorectal cancer (12%), congestive heart failure (CHF) (5%), venous thromboembolism (3%), atrial fibrillation (4%), acute myocardial infarction (11%), and dementia (2%). For the use of estrogen and progestogen combo-therapy, both E+ progestin and E+ progesterone were associated with increased risk of breast cancer by 10%-19%, but such risk can be mitigated using low dose of transdermal or vaginal E+ progestin. Moreover, E+ progestin exhibited significant risk reductions in endometrial cancer (45% or adjusted hazards ratio, 0.55; 95% CI, 0.50-0.60), ovarian cancer (21%), ischemic heart disease (5%), CHF (5%), and venous thromboembolism (5%), whereas E+ progesterone exhibited risk reduction only in CHF (4%). CONCLUSIONS: Among senior Medicare women, the implications of menopausal hormone therapy use beyond age 65 years vary by types, routes, and strengths. In general, risk reductions appear to be greater with low rather than medium or high doses, vaginal or transdermal rather than oral preparations, and with E2 rather than conjugated estrogen.

Trends in Racial Disparities in Healthcare Expenditures Among Senior Medicare Fee-for-service Enrollees in 2007-2020.

Despite the universal healthcare coverages, racial disparities in healthcare expenditures among senior Medicare beneficiaries exist. A few studies explored how racial disparities in healthcare expenditures changed over past decades and how it affected differently across 4 minoritized races, by type of Medicare and poverty levels. We conducted a longitudinal study of 21 healthcare expenditures from senior Medicare fee-for-service enrollees to determine overall and secular trends in racial disparities in healthcare expenditures between 2007 and 2020, during which the Affordable Care Act (ACA) came into full force and the COVID-19 pandemic had begun. We found important disparities in healthcare expenditures across 4 minoritized races compared to Whites, even after adjusting for possible confounders for such disparities. Disparities between Hispanics/Asians and Whites were much greater than disparities between Blacks and Whites, in all Parts A, B, and D expenditures. This reality has not been sufficiently emphasized in the literature. Importantly, Black-White disparities in total Part B expenditure gradually worsened between 2007 and 2020, and Hispanic-White and Asian-White disparities worsened greatly during that time window. Health planners need to focus on these large disparities and develop methods to shrink them.

Prevalence and characteristics of long COVID in elderly patients: An observational cohort study of over 2 million adults in the US.

BACKGROUND: Incidence of long COVID in the elderly is difficult to estimate and can be underreported. While long COVID is sometimes considered a novel disease, many viral or bacterial infections have been known to cause prolonged illnesses. We postulate that some influenza patients might develop residual symptoms that would satisfy the diagnostic criteria for long COVID, a condition we call "long Flu." In this study, we estimate the incidence of long COVID and long Flu among Medicare patients using the World Health Organization (WHO) consensus definition. We compare the incidence, symptomatology, and healthcare utilization between long COVID and long Flu patients. METHODS AND FINDINGS: This is a cohort study of Medicare (the US federal health insurance program) beneficiaries over 65. ICD-10-CM codes were used to capture COVID-19, influenza, and residual symptoms. Long COVID was identified by (a) the designated long COVID code B94.8 (code-based definition), or (b) any of 11 symptoms identified in the WHO definition (symptom-based definition), from 1 to 3 months post-infection. A symptom would be excluded if it occurred in the year prior to infection. Long Flu was identified in influenza patients from the combined 2018 and 2019 Flu seasons by the same symptom-based definition for long COVID. Long COVID and long Flu were compared in 4 outcome measures: (a) hospitalization (any cause); (b) hospitalization (for long COVID symptom); (c) emergency department (ED) visit (for long COVID symptom); and (d) number of outpatient encounters (for long COVID symptom), adjusted for age, sex, race, region, Medicare-Medicaid dual eligibility status, prior-year hospitalization, and chronic comorbidities. Among 2,071,532 COVID-19 patients diagnosed between April 2020 and June 2021, symptom-based definition identified long COVID in 16.6% (246,154/1,479,183) and 29.2% (61,631/210,765) of outpatients and inpatients, respectively. The designated code gave much lower estimates (outpatients 0.49% (7,213/1,479,183), inpatients 2.6% (5,521/210,765)). Among 933,877 influenza patients, 17.0% (138,951/817,336) of outpatients and 24.6% (18,824/76,390) of inpatients fit the long Flu definition. Long COVID patients had higher incidence of dyspnea, fatigue, palpitations, loss of taste/smell, and neurocognitive symptoms compared to long Flu. Long COVID outpatients were more likely to have any-cause hospitalization (31.9% (74,854/234,688) versus 26.8% (33,140/123,736), odds ratio 1.06 (95% CI 1.05 to 1.08, p < 0.001)), and more outpatient visits than long Flu outpatients (mean 2.9(SD 3.4) versus 2.5(SD 2.7) visits, incidence rate ratio 1.09 (95% CI 1.08 to 1.10, p < 0.001)). There were less ED visits in long COVID patients, probably because of reduction in ED usage during the pandemic. The main limitation of our study is that the diagnosis of long COVID in is not independently verified. CONCLUSIONS: Relying on specific long COVID diagnostic codes results in significant underreporting. We observed that about 30% of hospitalized COVID-19 patients developed long COVID. In a similar proportion of patients, long COVID-like symptoms (long Flu) can be observed after influenza, but there are notable differences in symptomatology between long COVID and long Flu. The impact of long COVID on healthcare utilization is higher than long Flu.

Effect of common maintenance drugs on the risk and severity of COVID-19 in elderly patients.

BACKGROUND: Maintenance drugs are used to treat chronic conditions. Several classes of maintenance drugs have attracted attention because of their potential to affect susceptibility to and severity of COVID-19. METHODS: Using claims data on 20% random sample of Part D Medicare enrollees from April to December 2020, we identified patients diagnosed with COVID-19. Using a nested case-control design, non-COVID-19 controls were identified by 1:5 matching on age, race, sex, dual-eligibility status, and geographical region. We identified usage of angiotensin-converting enzyme inhibitors (ACEI), angiotensin-receptor blockers (ARB), statins, warfarin, direct factor Xa inhibitors, P2Y12 inhibitors, famotidine and hydroxychloroquine based on Medicare prescription claims data. Using extended Cox regression models with time-varying propensity score adjustment we examined the independent effect of each study drug on contracting COVID-19. For severity of COVID-19, we performed extended Cox regressions on all COVID-19 patients, using COVID-19-related hospitalization and all-cause mortality as outcomes. Covariates included gender, age, race, geographic region, low-income indicator, and co-morbidities. To compensate for indication bias related to the use of hydroxychloroquine for the prophylaxis or treatment of COVID-19, we censored patients who only started on hydroxychloroquine in 2020. RESULTS: Up to December 2020, our sample contained 374,229 Medicare patients over 65 who were diagnosed with COVID-19. Among the COVID-19 patients, 278,912 (74.6%) were on at least one study drug. The three most common study drugs among COVID-19 patients were statins 187,374 (50.1%), ACEI 97,843 (26.2%) and ARB 83,290 (22.3%). For all three outcomes (diagnosis, hospitalization and death), current users of ACEI, ARB, statins, warfarin, direct factor Xa inhibitors and P2Y12 inhibitors were associated with reduced risks, compared to never users. Famotidine did not show consistent significant effects. Hydroxychloroquine did not show significant effects after censoring of recent starters. CONCLUSION: Maintenance use of ACEI, ARB, warfarin, statins, direct factor Xa inhibitors and P2Y12 inhibitors was associated with reduction in risk of acquiring COVID-19 and dying from it.

Association between tendon ruptures and use of fluoroquinolone, and other oral antibiotics: a 10-year retrospective study of 1 million US senior Medicare beneficiaries.

OBJECTIVES: To assess the association of fluoroquinolone use with tendon ruptures compared with no fluoroquinolone and that of the four most commonly prescribed non-fluoroquinolone antibiotics in the USA. DESIGN: Retrospective observational study. SETTING: US seniors enrolled in the federal old-age, survivor's insurance programme. PARTICIPANTS: 1 009 925 Medicare fee-for-service beneficiaries and their inpatient, outpatient, prescription drug records were used. INTERVENTIONS: Seven oral antibiotics, fluoroquinolones (ciprofloxacin, levofloxacin, moxifloxacin) and amoxicillin, amoxicillin-clavulanate, azithromycin and cephalexin. PRIMARY AND SECONDARY OUTCOME MEASURES: All tendon ruptures combined, and three types of tendon ruptures by anatomic site, Achilles tendon rupture, rupture of rotator cuff and other tendon ruptures occurred in 2007-2016. RESULTS: Of three fluoroquinolones, only levofloxacin exhibited a significant increased risk of tendon ruptures-16% (HR=1.16; 95% CI 1.06 to 1.28), and 120% (HR=2.20; 95% CI 1.50 to 3.24) for rotator cuff and Achilles tendon rupture, respectively, in the ≤30 days window. Ciprofloxacin (HR=0.96; 95% CI 0.89 to 1.03) and moxifloxacin (HR=0.59; 95% CI 0.37 to 0.93) exhibited no increased risk of tendon ruptures combined.Among the non-fluoroquinolone antibiotics, cephalexin exhibited increased risk of combined tendon ruptures (HR=1.31; 95% CI 1.22 to 1.41) and modest to large risks across all anatomic rupture sites (HRs 1.19-1.93) at ≤30 days window. Notably, the risk of levofloxacin never exceeded the risk of the non-fluoroquinolone, cephalexin in any comparison. CONCLUSIONS: In our study, fluoroquinolones as a class were not associated with the increased risk of tendon ruptures. Neither ciprofloxacin nor moxifloxacin exhibited any risk for tendon ruptures. Levofloxacin did exhibit significant increased risk. Cephalexin with no reported effect on metalloprotease activity had an equal or greater risk than levofloxacin; so we question whether metalloprotease activity has any relevance to observed associations with tendon rupture. Confounding by indication bias may be more relevant and should be given more consideration as explanation for significant associations in observational studies of tendon rupture.

Independent effects of 15 commonly prescribed drugs on all-cause mortality among US elderly patients with type 2 diabetes mellitus.

OBJECTIVE: Most patients with type 2 diabetes mellitus (T2DM) also have hypertension and hyperlipidemia. Consequently, they are taking medications for all three conditions concurrently and the effect of one drug could be confounded with that of another. This study aimed to determine the independent effects of 15 commonly prescribed medications for three conditions on the risk of all-cause mortality among elderly patients with T2DM. RESEARCH DESIGN AND METHODS: A cohort of 360 437 elderly patients with T2DM from 2007 to 2016 US Medicare data was traced along with cumulative uses of 8 diabetes, 6 hypertension and 1 hyperlipidemia drugs. The relative risk of all-cause mortality for each study drug was estimated using an extended Cox regression analysis adjusting for the concurrent use of other study drugs. RESULTS: Compared with the no use of each study medication, mortality risk declined with use of 3 diabetes drugs, sodium-glucose cotransporter-2 inhibitors (HR=0.73; 95% CI 0.64 to 0.84), glucagon-like peptide-1 receptor agonists (HR=0.75; 95% CI 0.70 to 0.80) and dipeptidyl peptidase-4 inhibitors (HR=0.94; 95% CI 0.91 to 0.98), the use of 3 blood pressure medications, diuretics (HR=0.89; 95% CI 0.87 to 0.92), angiotensin receptor blockers (HR=0.86; 95% CI 0.84 to 0.89), ACE inhibitors (HR=0.98; 95% CI 0.95 to 1.01) as well as statins (HR=0.83; 95% CI 0.80 to 0.85). It increased moderately with insulin (HR=1.55; 95% CI 1.51 to 1.59), sulfonylureas (HR=1.16; 95% CI 1.13 to 1.20), a small inconsistent amount with metformin (HR=1.05), beta-blockers (HR=1.07), dihydropyridine calcium-channel blockers (HR=0.99) and non-dihydropyridine calcium-channel blockers (HR=1.05). The use of thiazolidinedione had no effect. CONCLUSION: Among older patients with diabetes, mortality risk decreased importantly with three new diabetes drugs, 3 blood pressure drugs and statins. It increased moderately with sulfonylurea and insulin. Studies of aggressive use of new T2DM drugs instead of sulfonylureas and insulin are needed. Our statin results empirically validate two national guidelines for using statins in older patients with diabetes. However, 23% of study patients never took a statin, suggesting missed opportunities for prevention.

Simulating Variation in Families' Spending across Marketplace Plans.

OBJECTIVE: To examine variations in premium and cost-sharing across marketplace plans available to eligible families. DATA SOURCES: 2011-2012 Medical Expenditure Panel Survey (MEPS), 2014 health plan data from healthcare.gov, and the 2011 Medicare Part D public formulary file. STUDY DESIGN: We identified a nationally representative cohort of individuals in the MEPS who would have been eligible for marketplace coverage. For each family, we simulated the total out-of-pocket payment (premium plus cost-sharing) under each available plan in their county of residence, assuming their premarketplace use. DATA COLLECTION/EXTRACTION METHODS: Confidential state and county of residence identifiers were merged onto MEPS public use files and used to match MEPS families to the plans available in their county as reported in the publicly available data from healthcare.gov. PRINCIPAL FINDINGS: We found substantial variation in total family health care spending, especially premium component, across marketplace plans. This is true even within a plan tier of the same minimum actuarial value, and for families eligible for subsidies. Variation among families with income below 250 percent of the FPL is larger than variation among families with higher income. CONCLUSIONS: Our simulations show substantial variations in net premium and out-of-pocket payments across marketplace plans, even within a plan tier.

Risk of Alzheimer's Disease Among Senior Medicare Beneficiaries Treated With Androgen Deprivation Therapy for Prostate Cancer.

Purpose To assess the relative risk of Alzheimer's disease (AD) among patients with prostate cancer who received androgen deprivation therapy (ADT), after adjustment for other cancer therapies. Methods Data from demographics, survival, diagnoses codes, procedure codes, and other information about beneficiaries age 67 years or older in the Medicare claims database was assessed to determine the unadjusted and adjusted risks of AD and of dementia from ADT. The prespecified survival analysis method was competing risk regression. Results Of the 1.2 million fee-for-service Medicare beneficiaries who developed prostate cancer in 2001 to 2014, 35% received ADT. Of these, 109,815 (8.9%) and 223,765 (18.8%) developed AD and dementia, respectively, and 26% to 33% died without either outcome. Unadjusted rates of AD and all-cause mortality per 1,000 patient-years were higher among ADT recipients; the unadjusted rates of AD were 17.0 and 15.5 per 1,000 person-years in recipients and nonrecipients, respectively, and the unadjusted rates of all-cause mortality were 73.0 and 51.6 per 1,000 person-years, respectively. The unadjusted rates for dementia in ADT recipients versus nonrecipients were 38.5 and 32.9, respectively, and the unadjusted rates of mortality were 60.2 versus 40.4, respectively. However, after analysis was adjusted for other cancer therapies and other covariates, patients with ADT treatment had no increased risk of AD (subdistribution hazard ratio [SHR], 0.98; 95% CI, 0.97 to 0.99) and had only a miniscule (1%) risk of dementia (SHR, 1.01; 95% CI, 1.01 to 1.02); patients treated with ADT were more likely to die before progression to AD (SHR, 1.24; 95% CI, 1.23 to 1.24) or dementia (SHR, 1.26; 95% CI, 1.25 to 1.26). The risks of AD and dementia were not associated with duration of ADT (ie, no dose effect). Other secondary analyses confirmed these results. Conclusion These data suggest that ADT treatment has no hazard for AD and no meaningful hazard for dementia among men age 67 years or older who are enrolled in Medicare.

Trends in Off-Label Use of Second-Generation Antipsychotics in the Medicare Population From 2006 to 2012.

OBJECTIVE: The study evaluated trends in the off-label use of second-generation antipsychotics in the Medicare population, a practice that has been identified as lacking adequate supporting evidence for many indications. METHODS: Medicare claims data from 2006 to 2012 were used to identify beneficiaries who filled at least one prescription for any second-generation antipsychotic. Any use that was not associated with a medical claim for an approved indication in a given year was classified as off-label use. Rates of off-label use and of diagnoses associated with off-label use were compared over time. Fill counts standardized for 30-day supply and costs were compared by type of use. RESULTS: On the basis of a sample of 490,314 patient-years, the rate of off-label use among beneficiaries prescribed a second-generation antipsychotic declined from 51% to 45%. Fill counts were 16% lower for off-label users compared with on-label users. Off-label users had higher out-of-pocket costs but lower total costs for second-generation antipsychotics. Off-label users most commonly had claims related to dementia, minor depression, anxiety disorders, and other psychosis. The proportion of off-label users without any claims for the most common off-label uses of second-generation antipsychotics declined from 45% in 2006 to 30% in 2012. CONCLUSIONS: Off-label use of second-generation antipsychotics has declined, especially among persons without any of the common off-label conditions. The diagnoses accompanying off-label use did not systematically reflect changes in the evidence base for the use of these drugs, suggesting a mismatch between evidence supporting the use of off-label second-generation antipsychotics and prescribing practices.

Trends in Use of Medications for Smoking Cessation in Medicare, 2007-2012.

INTRODUCTION: Smoking-related disease accounts for 10% of Medicare expenditures. Although clinical guidelines recommend smoking-cessation medications, they are subject to safety warnings from the U.S. Food and Drug Administration (FDA). This study investigated trends in utilization of smoking-cessation medications in Medicare from 2007 to 2012. METHODS: Data on medical claims and prescription drugs for a nationally representative sample of Medicare beneficiaries were used to study trends from 2007 to 2012 in use of smoking-cessation medications (bupropion, nicotine-replacement therapy, varenicline), among beneficiaries who used tobacco (N=205,675). Analyses were conducted in 2015. Multinomial logistic regression was used to examine differences in use of bupropion, nicotine-replacement therapy, varenicline, or more than one medication, relative to none, by beneficiaries' health and demographic characteristics. Binary logistic regression calculated average predicted probabilities of cardiovascular disease or depression among medication users before and after FDA safety warnings related to those conditions. RESULTS: Sixteen percent of tobacco users ever filled a prescription for a smoking-cessation medication. The proportion of beneficiaries who filled prescriptions for varenicline increased in 2007 but sharply declined corresponding to public warnings about adverse effects, although the same trends did not occur for bupropion or nicotine-replacement therapy. After FDA safety concerns were published, the average predicted probability of beneficiaries filling varenicline prescriptions with cardiovascular disease declined by 31%, although the average predicted probability of depression did not decline. CONCLUSIONS: Use of smoking-cessation medications among Medicare beneficiaries remains low. Health effects of Medicare policies that increase coverage for medical support for smoking cessation may be limited by low utilization of effective medications.

Evaluating the Initiation of Novel Oral Anticoagulants in Medicare Beneficiaries.

BACKGROUND: As alternatives to warfarin, 2 novel oral anticoagulants (NOACs), dabigatran and rivaroxaban, were approved in 2010 and 2011 to prevent stroke and other thromboembolic events in patients with atrial fibrillation. It is unclear how patient characteristics are associated with the initiation of anticoagulants. OBJECTIVE: To evaluate how patient demographics, clinical characteristics, types of insurance, and patient out-of-pocket spending affect the initiation of warfarin and 2 NOACs--dabigatran and rivaroxaban. METHODS: We used pharmacy claims data from a 5% random sample of Medicare beneficiaries to identify patients who were newly diagnosed with atrial fibrillation between October 1, 2010, and October 31, 2012, and who were prescribed an oral anticoagulant within 60 days of diagnosis. We identified key predictors of initiation of NOACs using a multinomial logistic regression model with generalized logit link. RESULTS: Patients who were black and who had a history of acute myocardial infarction, stroke or transient ischemic attack, chronic kidney disease, or congestive heart failure were significantly associated with lower odds of receiving NOACs compared with warfarin. Age greater than 65 years, a history of hypertension, and use of nonsteroidal anti-inflammatory drugs were positively associated with the initiation of NOACs. Rivaroxaban was most likely to be initiated among women, followed by warfarin and dabigatran. Individuals receiving a low-income subsidy were more likely to initiate warfarin than NOACs, even though they paid little copayment. Individuals with supplemental Part D drug coverage, such as national Programs for All-Inclusive Care for the Elderly or employer-sponsored plans, were more likely to initiate NOACs compared with warfarin. CONCLUSIONS: We found that race, sex, type of Part D plans, and some clinical conditions were associated with the initiation of NOACs relative to warfarin. But patient demographic and clinical characteristics did not appear to affect which particular NOAC patients initiated.

Analysis of Healthcare Cost and Utilization in the First Two Years of the Medicare Shared Savings Program Using Big Data from the CMS Enclave.

The Medicare Shared Savings Program (MSSP) is the larger of the first two Accountable Care Organization (ACO) programs by the Centers for Medicare and Medicaid Services (CMS). In this study we assessed healthcare cost and utilization of 1.71 million Medicare beneficiaries assigned to the 333 MSSP ACOs in the calendar years of 2013 and 2014, in comparison to years 2010 and 2011, using the official CMS data. We employed doubly robust estimation (propensity score weighting followed by generalized linear regression) to adjust the analyses to beneficiary personal traits, history of chronic conditions, previous healthcare utilization, ACO administrative region, and ZIP code socioeconomic factors. In comparison to the care delivered to the control cohort of 17.7 million non-ACO beneficiaries, we found that the care patterns for ACO beneficiaries shifted away from some costly types of care, but at the expense of increased utilization of other types, increased imaging and testing expenditures, and increased medication use, with overall net greater increase in cost instead of smaller increase.

Part D Plan Switching Among Medicare Beneficiaries With Schizophrenia.

OBJECTIVE: Most Medicare schizophrenia patients were randomly assigned in 2006 to one of 409 benchmark plans. This study examined plan switching and factors affecting switching among beneficiaries with schizophrenia. METHODS: The data were 2006 Medicare pharmacy data for three groups of schizophrenia patients: those with Medicaid coverage ("dual eligibles"; N=93,705), Medicare beneficiaries with a low-income subsidy (N=56,148), and Medicare beneficiaries without the subsidy (N=36,107). Switching frequency and how patient and plan characteristics affected switching were examined. RESULTS: Beneficiaries who switched their Part D plan at least once included 10.7% of the dual eligibles, 9.8% of those with a subsidy, and 5.5% of those without. Several factors affected likelihood of switching, including age, geographic region, and proportion of prescriptions filled by beneficiaries who were covered or whose prescriptions required utilization review in the original plan. CONCLUSIONS: Plan switching among Medicare beneficiaries with schizophrenia was relatively infrequent but may be driven by the need for better drug coverage and less restrictive utilization policies.

Use of intelligent assignment to Medicare Part D plans for people with schizophrenia could produce substantial savings.

Medicare insures about half of the people in the United States diagnosed with schizophrenia. More than 90 percent of these beneficiaries are eligible for a low-income subsidy for their Part D prescription drug benefit, and the great majority of them are randomly assigned to a stand-alone drug plan. We simulated savings from replacing random assignment with an "intelligent assignment" algorithm that would assign beneficiaries to the least expensive plan in 2010 based on their drug usage in the previous year. Doing so generated projected annual drug savings of $379 per dual-eligible (those enrolled in both Medicaid and Medicare) beneficiary with a low-income subsidy; $404 per non-dual eligible with the subsidy; and $604 per beneficiary for those without the subsidy who chose their own plans. This translates into savings of $466 per beneficiary with schizophrenia. Intelligent assignment could have saved about $150 million for Medicare and beneficiaries with schizophrenia combined in 2010. We recommend that Medicare use intelligent assignment as the default approach for all beneficiaries with schizophrenia who receive a low-income subsidy, and consider it as an option for all Part D beneficiaries, regardless of their income.

Risk of bleeding with dabigatran in atrial fibrillation.

IMPORTANCE: It remains unclear whether dabigatran etexilate mesylate is associated with higher risk of bleeding than warfarin sodium in real-world clinical practice. OBJECTIVE: To compare the risk of bleeding associated with dabigatran and warfarin using Medicare data. DESIGN, SETTING, AND PARTICIPANTS: In this retrospective cohort study, we used pharmacy and medical claims in 2010 to 2011 from a 5% random sample of Medicare beneficiaries. We identified participants as those newly diagnosed as having atrial fibrillation from October 1, 2010, through October 31, 2011, and who initiated dabigatran or warfarin treatment within 60 days of initial diagnosis. We followed up patients until discontinued use or switch of anticoagulants, death, or December 31, 2011. EXPOSURES: Dabigatran users (n = 1302) and warfarin users (n = 8102). MAIN OUTCOMES AND MEASURES: We identified any bleeding events and categorized them as major and minor bleeding by anatomical site. Major bleeding events included intracranial hemorrhage, hemoperitoneum, and inpatient or emergency department stays for hematuria, gastrointestinal, or other hemorrhage. We used a propensity score weighting mechanism to balance patient characteristics between 2 groups and Cox proportional hazards regression models to evaluate the risk of bleeding. We further examined the risk of bleeding for 4 subgroups of high-risk patients: those 75 years or older, African Americans, those with chronic kidney disease, and those with more than 7 concomitant comorbidities. RESULTS: Dabigatran was associated with a higher risk of bleeding relative to warfarin, with hazard ratios of 1.30 (95% CI, 1.20-1.41) for any bleeding event, 1.58 (95% CI, 1.36-1.83) for major bleeding, and 1.85 (95% CI, 1.64-2.07) for gastrointestinal bleeding. The risk of intracranial hemorrhage was higher among warfarin users, with a hazard ratio of 0.32 (95% CI, 0.20-0.50) for dabigatran compared with warfarin. Dabigatran was consistently associated with an increased risk of major bleeding and gastrointestinal hemorrhage for all subgroups analyzed. The risk of major bleeding among dabigatran users was especially high for African Americans and patients with chronic kidney disease. CONCLUSIONS AND RELEVANCE: Dabigatran was associated with a higher incidence of major bleeding (regardless of the anatomical site), a higher risk of gastrointestinal bleeding, but a lower risk of intracranial hemorrhage. Thus, dabigatran should be prescribed with caution, especially among high-risk patients.

A simple change to the Medicare Part D low-income subsidy program could save $5 billion.

Medicare Part D provides a subsidy to beneficiaries with incomes below 150 percent of the federal poverty level. Enrollees with the low-income subsidy accounted for 75 percent of the $60 billion in total federal Part D spending in 2013. The government randomly assigns any new beneficiary who automatically qualifies for the subsidy, or who successfully applies for it without indicating a preferred plan, to a stand-alone Part D plan whose premium is equal to or below the average premium for the basic Part D benefit in the region. We used an intelligent reassignment algorithm and 2008-09 Part D drug use and spending data to match enrollees to available plans according to their medication needs. We found that such a reassignment approach could have saved the federal government over $5 billion in 2009, for mean government savings of $710 (median: $368) per enrollee with a low-income subsidy. Implementing that simple change to reassign beneficiaries would have also lowered the proportion of prescriptions that required utilization review from 29 percent to 20 percent, and the proportion of prescriptions with quantity limits from 27 percent to 19 percent.

Race/Ethnicity, disability, and medication adherence among medicare beneficiaries with heart failure.

BACKGROUND: Recent and national data on adherence to heart failure drugs are limited, particularly among the disabled and some small minority groups, such as Native Americans and Hispanics. OBJECTIVE: We compare medication adherence among Medicare patients with heart failure, by disability status, race/ethnicity, and income. DESIGN: Observational study. SETTING: US Medicare Parts A, B, and D data, 5% random sample, 2007-2009. PARTICIPANTS: 149,893 elderly Medicare beneficiaries and 21,204 disabled non-elderly beneficiaries. MAIN MEASURES: We examined 5% of Medicare fee-for-service beneficiaries with heart failure in 2007-2009. The main outcome was 1-year adherence to one of three therapeutic classes: ß-blockers, diuretics, and angiotensin-converting enzyme inhibitors (ACEIs)/angiotensin II receptor blockers (ARBs). Adherence was defined as having prescriptions in possession for ≥ 75% of days. KEY RESULTS: Among aged beneficiaries, 1-year adherences to at least one heart failure drug were 63%, 57%, 53%, 50%, and 52% for Whites, Asians, Hispanics, Native Americans and Blacks, respectively; among the disabled, 1-year adherence was worse for each group: 57%, 53%, 48%, 44% and 43% respectively. The racial/ethnic difference persisted after adjustment for age, gender, income, drug coverage, location and health status. Patterns of adherence were similar among beneficiaries on all three therapeutic classes. Among beneficiaries with close-to-full drug coverage, minorities were still less likely to adhere relative to Whites, OR = 0.61 (95% CI 0.58-0.64) for Hispanics, OR = 0.59 (95% CI 0.57-0.62) for Blacks and OR = 0.57 (95% CI 0.47-0.68) for Native Americans. CONCLUSION: After the implementation of Medicare Part D, adherence to heart failure drugs remains problematic, especially among disabled and minority beneficiaries, including Native Americans, Blacks, and Hispanics. Even among those with close-to-full drug coverage, racial differences remain, suggesting that policies simply relying on cost reduction cannot eliminate racial differences.

Medication adherence and readmission after myocardial infarction in the Medicare population.

OBJECTIVES: To examine the relationship between 6-month medication adherence and 1-year downstream heart disease-related readmission among patients who survived a myocardial infarction (MI). STUDY DESIGN: Retrospective, nested case-control analysis of Medicare fee-for-service beneficiaries who were discharged alive post MI in 2008 (n = 168,882). METHODS: Patients in the case group had their first heart-disease-related readmission post MI discharge during the 6-to-9-month period or the 9-to-12-month period. We then used propensity score matching to identify patients in the control group who had similar characteristics, but did not have a readmission in the same time window. Adherence was defined as the average 6-month medication possession ratio (MPR) prior to the first date of the time-window defining readmission. RESULTS: After controlling for demographics, insurance coverage, and clinical characteristics, patients who had a heart-disease-related readmission had worse adherence, with MPRs of 0.70 and 0.74 in the case and control groups, respectively. Odds ratio of MPR ≥ 0.75 was 0.79 (95% CI, 0.75-0.83) among those with a readmission relative to those without. CONCLUSIONS: Our study shows that better 6-month medication adherence may reduce heart-disease-related readmissions within a year after an MI.

Effects of Medicare Part D coverage gap on medication adherence.

OBJECTIVES: To evaluate the effects of the Medicare Part D coverage gap on pharmacy use among a national sample of Medicare beneficiaries and on medication adherence among 2 subsamples with heart failure and/or diabetes. STUDY DESIGN: Pre-post design, with comparison group and propensity score weighting. METHODS: We used a 5% random sample of elderly Medicare beneficiaries enrolled in stand-alone Part D plans in 2007. The comparison group had full coverage in the gap, whereas the 2 study groups had either no coverage or generic-only coverage in the gap. Main outcomes included probability of filling a prescription, monthly pharmacy spending and number of prescriptions filled, and adherence measured by medication possession ratios. RESULTS: Relative to the comparison group, beneficiaries without drug coverage in the gap reduced the number of prescriptions filled per month by 16.0% (95% confidence interval [CI], 15.5%-16.5%); those with generic drug coverage in the gap reduced it by 10.8% (95% CI, 10.3%-11.4%). Most of the reduction was attributable to reduced use of brand-name drugs. Beneficiaries with heart failure reduced adherence to heart failure drugs by 3.6% (95% CI, 2.9%-4.2%) and beneficiaries with diabetes reduced antidiabetic medication adherence by 10.3% (95% CI, 9.4%-11.3%). CONCLUSIONS: Medicare beneficiaries reduced medication use (mainly brand-name drugs) after entering the coverage gap. This result suggests that while beneficiaries' financial burden would continue because of the coverage gap, the gap would not result in a large reduction in medication adherence for essential drugs for diabetes and heart failure.