Dataset Information

Changes in drug utilization during a gap in insurance coverage: an examination of the medicare Part D coverage gap.

ABSTRACT:

Background

Nations are struggling to expand access to essential medications while curbing rising health and drug spending. While the US government's Medicare Part D drug insurance benefit expanded elderly citizens' access to drugs, it also includes a controversial period called the "coverage gap" during which beneficiaries are fully responsible for drug costs. We examined the impact of entering the coverage gap on drug discontinuation, switching to another drug for the same indication, and drug adherence. While increased discontinuation of and adherence to essential medications is a regrettable response, increased switching to less expensive but therapeutically interchangeable medications is a positive response to minimize costs.

Methods and findings

We followed 663,850 Medicare beneficiaries enrolled in Part D or retiree drug plans with prescription and health claims in 2006 and/or 2007 to determine who reached the gap spending threshold, n?=?217,131 (33%). In multivariate Cox proportional hazards models, we compared drug discontinuation and switching rates in selected drug classes after reaching the threshold between all 1,993 who had no financial assistance during the coverage gap (exposed) versus 9,965 multivariate propensity score-matched comparators with financial assistance (unexposed). Multivariate logistic regressions compared drug adherence (? 80% versus >80% of days covered). Beneficiaries reached the gap spending threshold on average 222 d ±79. At the drug level, exposed beneficiaries were twice as likely to discontinue (hazard ratio [HR] ?=?2.00, 95% confidence interval [CI] 1.64-2.43) but less likely to switch a drug (HR ?=?0.60, 0.46-0.78) after reaching the threshold. Gap-exposed beneficiaries were slightly more likely to have reduced adherence (OR ?=?1.07, 0.98-1.18).

Conclusions

A lack of financial assistance after reaching the gap spending threshold was associated with a doubling in discontinuing essential medications but not switching drugs in 2006 and 2007. Blunt cost-containment features such as the coverage gap have an adverse impact on drug utilization that may conceivably affect health outcomes.

SUBMITTER: Polinski JM

PROVIDER: S-EPMC3156689 | biostudies-literature | 2011 Aug

REPOSITORIES: biostudies-literature

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Publications

Changes in drug utilization during a gap in insurance coverage: an examination of the medicare Part D coverage gap.

Polinski Jennifer M JM Shrank William H WH Huskamp Haiden A HA Glynn Robert J RJ Liberman Joshua N JN Schneeweiss Sebastian S

PLoS medicine 20110816 8

<h4>Background</h4>Nations are struggling to expand access to essential medications while curbing rising health and drug spending. While the US government's Medicare Part D drug insurance benefit expanded elderly citizens' access to drugs, it also includes a controversial period called the "coverage gap" during which beneficiaries are fully responsible for drug costs. We examined the impact of entering the coverage gap on drug discontinuation, switching to another drug for the same indication, a ...[more]

PMID: 21857811

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Project description:More than 1 in 5 disabled people with dual Medicare-Medicaid enrollment have schizophrenia or a bipolar disorder (ie, a serious mental illness). The effect of their transition from Medicaid drug coverage, which varies in generosity across states, to the Medicare Part D drug benefit is unknown. Many thousands make this transition annually.To determine the effect of transitioning from Medicaid drug benefits to Medicare Part D on medication use by patients with a serious mental illness and to determine the influence of Medicaid drug caps.In time-series analysis of continuously enrolled patient cohorts (2004-2007), we estimated changes in medication use before and after transitioning to Part D, comparing states that capped monthly prescription fills with states with no prescription limits. We used Medicaid and Medicare claims from a 5% national sample of community-dwelling, nonelderly disabled dual enrollees with schizophrenia (n?=?5554) or bipolar disorder (n?=?3675).Psychotropic treatments included antipsychotics for schizophrenia and antipsychotics, anticonvulsants, and lithium for bipolar disorder. We measured monthly rates of untreated illness, intensity of treatment, and overall prescription medication use.Prior to Part D, the prevalence of untreated illness among patients with a bipolar disorder was 30.0% in strict-cap states and 23.8% in no-cap states. In strict-cap states, the proportion of untreated patients decreased by 17.2% (relatively) 1 year after Part D, whereas there was no change in the proportion of untreated patients in no-cap states. For patients with schizophrenia, the untreated rate (20.6%) did not change in strict-cap states, yet it increased by 23.3% (from 11.6%) in no-cap states. Overall medication use increased substantially after Part D in strict-cap states: prescription fills were 35.5% higher among patients with a bipolar disorder and 17.7% higher than predicted among schizophrenic patients; overall use in no-cap states was unchanged in both cohorts.The effects of transitioning from Medicaid to Medicare Part D on essential treatment of serious mental illness vary by state. Transition to Part D in states with strict drug benefit limits may reduce rates of untreated illness among patients with bipolar disorders, who have high levels of overall medication use. Access to antipsychotic treatment may decrease after Part D for patients with a serious mental illness living in states with relatively generous uncapped Medicaid coverage.

Project description:Policy Points Only a small minority of new drugs in "nonprotected" classes are widely covered by Part D plans nationwide in the year after US Food and Drug Administration (FDA) approval. Part D plans frequently apply utilization management restrictions such as prior authorizations to newly approved drugs in both protected and nonprotected classes. Drug price influences both formulary inclusion (in nonprotected classes) and coverage restrictions (in both protected and nonprotected classes), while other drug characteristics such as therapeutic benefits are not consistently associated with formulary design. Plans do not seem to favor the minority of drugs that are determined to offer added therapeutic benefit over existing alternatives.ContextMedicare Part D is an outpatient prescription drug benefit for older Americans covering more than 46 million beneficiaries. Except for mandatory coverage for essentially all drugs in six protected classes, plans have substantial flexibility in how they design their formularies: which drugs are covered, which drugs are subject to restrictions, and what factors determine formulary placement. Our objective in this paper was to document the extent to which Part D plans limit coverage of newly approved drugs.MethodsWe examined the formulary design of 4,582 Part D plans from 2014 through 2018 and measured (1) the decision to cover newly approved drugs in nonprotected classes, (2) use of utilization management tools in protected and nonprotected classes, and (3) the association between plan design and drug-level characteristics such as 30-day cost, therapeutic benefit, and the US Food and Drug Administration (FDA) expedited regulatory pathway.FindingsThe FDA approved 109 new drugs predominantly used in outpatient settings between 2013 and 2017. Of these, 75 fell outside of the six protected drug classes. One-fifth of drugs in nonprotected classes (15 out of 75) were covered by more than half of plans during the first year after approval. Coverage was often conditional on utilization management strategies in both protected and nonprotected classes: only seven drugs (6%) were covered without prior authorization requirements in more than half of plans. Higher 30-day drug costs were associated with more widespread coverage in nonprotected classes: drugs that cost less than $150 for a 30-day course were covered by fewer than 20% of plans while those that cost more than $30,000 per 30 days were covered by more than 50% of plans. Plans were also more likely to implement utilization management tools on high-cost drugs in both protected and nonprotected classes. A higher proportion of plans implemented utilization management strategies on covered drugs with first-in-class status than drugs that were not first in class. Other drug characteristics, including availability of added therapeutic benefit and inclusion in FDA expedited regulatory approval, were not consistently associated with plan coverage or formulary restrictions.ConclusionsNewly approved drugs are frequently subject to formulary exclusions and restrictions in Medicare Part D. Ensuring that formulary design in Part D is linked closely to the therapeutic value of newly approved drugs would improve patients' welfare.

Project description:Importance:Benzodiazepines, which are associated with safety-related harms for older adults, were not covered when the US Medicare Part D prescription drug benefit began. Coverage was extended to benzodiazepines in 2013. Objective:To examine whether the expansion of benzodiazepine coverage among Medicare Advantage (MA) beneficiaries was associated with increases in fall-related injuries or overdoses among older adults. Design, Setting, and Participants:This ecological study used interrupted time-series with comparison-series analyses of MA claims data from 4?635?312 age-eligible MA beneficiaries and 940?629 commercially insured individuals (comparison group) stratified by age (65-69, 70-74, 75-79, and ?80 years) to separately compare trends in fall-related injury and overdose before (January 1, 2010, to December 31, 2012) and after (January 1, 2013, to December 31, 2015) coverage expansion for benzodiazepines. Data analysis was performed from September 1, 2018, to August 31, 2019. Exposures:Expansion of benzodiazepine coverage in Medicare Part D in 2013. Main Outcomes and Measures:Monthly rate of fall-related injury and overdose. Results:In 2012 (the year before the policy change), women constituted 57.5% of the MA group and 47.4% of the comparison group. A total of 25.8% of individuals in the MA group were aged 65 to 69 years, and 29.3% were 80 years or older (mean [SD], 75.1 [6.4] years); 56.7% of individuals in the comparison group were aged 65 to 69 years, and 15.1% were 80 years or older (mean [SD] age, 70.9 [6.5] years). In the MA group, 4?635?312 individuals contributed 156?754?749 person-months from 2010 through 2015; in the comparison group, 940?629 individuals contributed 25?104?534 person-months. After coverage of benzodiazepines began, the rate (ie, slope) of fall-related injury among MA beneficiaries increased from before to after coverage among all age groups. Compared with the comparison group, the increase in rate was statistically significant for those 80 years or older (rate changes for the MA vs comparison groups: 0.12 [95% CI, 0.07 to 0.17] vs -0.01 [95% CI, -0.11 to 0.10]; P?=?.04 for interaction). The overdose trend changed from decreasing to increasing among MA beneficiaries after coverage for all age groups, with a statistically significant increase compared with the comparison group among those aged 65 to 69 years (rate changes for the MA vs comparison groups: 0.23 [95% CI, 0.17 to 0.30] vs 0.02 [95% CI, -0.06 to 0.11]; P?<?.001 for interaction) and among those 80 years or older (rate changes for the MA vs comparison groups: 0.07 [95% CI, 0.00 to 0.14] vs -0.20 [95% CI, -0.35 to -0.05]; P?=?.002 for interaction). Results among MA beneficiaries were consistent when stratified by sex and when limited to those prescribed opioids. Conclusions and Relevance:Medicare's expansion of benzodiazepine coverage may have been associated with increases in the rates of overdose among adults ages 65 to 69 years and in the rates of overdose and fall-related injury among those 80 years or older.

Dataset Information

Changes in drug utilization during a gap in insurance coverage: an examination of the medicare Part D coverage gap.

Background

Methods and findings

Conclusions

Publications

Changes in drug utilization during a gap in insurance coverage: an examination of the medicare Part D coverage gap.

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