Bipolar Disorder
Conditions
Keywords
high-deductible health plans, medication adherence
Brief summary
Using eleven years (2004-2014) of claims data from the largest US commercial health insurer, the investigators will assess the impact of switching into high-deductible health plans (HDHPs) on outcomes for patients with bipolar disorder. Patient subgroups will include patients with and without high medication cost-sharing and vulnerable populations (racial/ethnic minorities, poor, rural, major comorbidities). Interviews with patients and caregivers recruited through a major advocacy group will provide further insights into the policy issues with real-life experiences.
Detailed description
Bipolar disorder is a severe mental illness affecting about 3% of the U.S. population that causes personal suffering, morbidity, and premature mortality. Continuous access to medications, close monitoring, and other psychiatric care are crucial for avoiding complications of bipolar disorder such as relapse, hospitalization, and suicide. To control rising costs, payers and employers are increasingly adopting high-deductible health plans (HDHPs) with very high out-of-pocket payments. Federally-defined Health Savings Account HDHPs require full cost-sharing for all non-preventive services, including medications and specialist visits; family deductibles for HSA-HDHPs range from $2,500 to $12,700. Enrollment in HDHPs quadrupled nationally between 2006 and 2013 to 38% of all workers. Analysts expect further explosive growth because of continued health care cost pressure on families and employers. Well-informed patients in HDHPs might reduce use of unnecessary services and more expensive treatment options. However, patients might also choose to forego needed care. There is very little evidence on how particularly vulnerable patients such as those with bipolar disorder or other chronic mental illnesses fare when forced to make complex choices about spending for care under HDHPs. Given their rapid escalation, there is an urgent need to understand how vulnerable patients change their patterns of care and medication adherence under HDHPs. We will compare patients with three types of insurance: traditional plans with low or no deductible; HDHPs in which chronic medications are paid fully out-of-pocket until the deductible is met; and HDHPs where medications are subject to the same co-pays as in traditional plans. OBJECTIVES: Using ten years of data from the largest U.S. commercial health insurer (\ 70 million members in all 50 states), we will assess the impact of HDHPs on key outcomes for patients with bipolar disorder experiencing employer-mandated shifts from traditional insurance to HDHPs. Our specific aims are to evaluate: (1) changes in medication adherence, and in intensity and quality of other health care; (2) changes in adverse events; and, (3) changes in patient out-of-pocket costs. We will compare how these outcomes differ for patients in HDHPs with and without medications subject to the deductible. We will assess effects in the overall population of patients with bipolar illness and in specific vulnerable subgroups, including racial/ethnic minorities, poorer patients, rural patients, and patients with other important comorbidities. METHODS: We will take advantage of an ongoing natural experiment whereby employers have shifted all their employees at once from traditional insurance to HDHPs. We will use the strongest quasi-experimental, longitudinal methods available to compare the experience of patients switched by their employers into HDHPs with contemporaneous patients whose employers remain in traditional plans. A major advantage of our approach is the inclusion of only employers whose employees had no choice of insurance plans, minimizing member-level selection bias. From preliminary data queries, we estimate a study population of \ 160,000 members with bipolar disorder from 2004-2013. Our data include detailed information about insurance type, diagnoses, health services and pharmacy utilization, out-of-pocket payments, individual-level patient characteristics like income, and neighborhood-level factors like racial density. The unprecedented large sample size will allow us to answer questions about how patients from particular vulnerable subgroups respond to HDHPs, including patients who are Black or Hispanic, have low incomes, reside in rural areas, and have major comorbidities. PATIENT OUTCOMES: Our Aim 1 measures of the quality of bipolar treatment will include indicators of patients' access to appropriate care: prevalence and intensity of use of effective medications (antipsychotics, anticonvulsants); medication adherence; and, guideline-recommended clinical monitoring (regular outpatient mental health visits). Adverse events in Aim 2 will include psychiatric hospitalizations, which are potentially avoidable and often viewed as an indicator of suboptimal outpatient care. In Aim 3, we will assess changes under HDHPs in the co-payment amounts faced by patients for specific medical services, such as prescription fills and clinician visits, and the total burden of patient out-of-pocket costs. PATIENT AND STAKEHOLDER ENGAGEMENT: Our longstanding engagement with the National Alliance on Mental Illness (NAMI, the preeminent patient advocacy organization addressing issues around bipolar disorder) has shaped our study aims and our focus on measurable outcomes of particular concern to patients. We will solicit regular input from a local patient and family advisory panel (assembled with NAMI's assistance) on the refinement of methods, interpretation of study findings, shaping of recommendations, and dissemination of results. As study consultant, NAMI Medical Director Dr. Ken Duckworth will guide meetings of the patient panel and contribute perspectives from the broader community of patients and clinicians dealing with bipolar illness. Dr. Greg Simon, Director of the US Mental Health Research Network, will provide national expertise on patient experiences with serious mental illness in health plans. ANTICIPATED IMPACT: Our research will provide empirical data comparing how patients with bipolar illness fare under three insurance designs with vastly different requirements for cost-sharing. At a time when HDHP enrollment is exploding, the experience of patients with serious mental illnesses is largely unexamined. Advocacy groups will be able to use our findings to lobby for more patient-responsive benefit designs; policymakers will have evidence to redesign insurance benefits to better address the needs of vulnerable patients (e.g., by exempting mood stabilizing agents from deductibles).
Interventions
Investigators will conduct in-depth interviews with approximately 40 commercially insured individuals with bipolar disorder or their family caregivers to explore how they navigate deductibles, copayments, and other complex insurance features. Investigators will also determine the health care services that patients most value and assess how they prioritize difficult health care cost tradeoffs.
Sponsors
Study design
Eligibility
Inclusion criteria
(for both study intervention/control groups): \[Intervention Cohort\]: * Traditional plan members with bipolar illness. * Experience an employer-mandated switch to HSA-eligible HDHPs with full drug cost-sharing. \[Control Cohort\]: * Members with bipolar illness. * Members whose employers offered only a traditional plan for the follow-up year.
Exclusion criteria
* Members age 65 years or older who could be eligible for Medicare benefits, including drug coverage through Medicare Part D. * Members whose employer offered a choice of health plan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inpatient Hospitalizations Among Bipolar Patients | Year 3 | Mean number of annual inpatient hospitalizations in the follow-up period among bipolar patients |
| Emergency Department Visits Among Patients With Bipolar Disorder | Year 3 | Mean number of annual emergency department visits in the follow-up period among bipolar patients |
| Medication Adherence for Bipolar Disorder | YEAR 2 | Mean number of annual bipolar medication fills in the follow-up period among bipolar patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Access To Outpatient Services for Bipolar Disorder | YEAR 2 | Mean number of annual outpatient mental health visits for bipolar patients, averaged across baseline and follow-up periods |
| Medication Adherence for Bipolar Disorder - Psychotropic Medications | YEAR 2 | Mean number of annual psychotropic medication fills in the follow-up period among bipolar patients |
Other
| Measure | Time frame | Description |
|---|---|---|
| Annual Patient Out-of-pocket Costs for Patients With Bipolar Disorder | YEAR 2, YEAR 3 | Annual patient out-of-pocket costs (paid deductible, coinsurance, and copayment amounts) for patients with Bipolar Disorder in the baseline period |
Participant flow
Recruitment details
Participants were identified in claims data. Each was required to have one inpatient episode or two outpatient visits with a corresponding diagnosis of bipolar disorder. Patients with schizophrenia or schizoaffective disorder were excluded.
Pre-assignment details
Study participants without either a) two years of continuous enrollment in a low-deductible health plan OR b) one year of enrollment in a low-deductible plan followed by a continuous year of enrollment in a high-deductible plan were excluded. This brought the sample size from 350,823 to 97,302.
Participants by arm
| Arm | Count |
|---|---|
| High-Deductible Health Plan Group Insurance plan members with one year in a low-deductible plan (less than or equal to $500 per year), followed by an employer mandated switch to a high-deductible plan (greater than or equal to $1,000 per year) | 3,517 |
| Control Group Insurance plan members with two consecutive years in employer-mandated low-deductible plans (less than or equal to $500 per year) | 37,776 |
| Total | 41,293 |
Baseline characteristics
| Characteristic | High-Deductible Health Plan Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 38.3 years STANDARD_DEVIATION 13.7 | 38.3 years STANDARD_DEVIATION 14.1 | 38.3 years STANDARD_DEVIATION 14.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 126 Participants | 1584 Participants | 1458 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3391 Participants | 39709 Participants | 36318 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 38 Participants | 557 Participants | 519 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 451 Participants | 422 Participants |
| Race (NIH/OMB) More than one race | 685 Participants | 9386 Participants | 8701 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 166 Participants | 2318 Participants | 2152 Participants |
| Race (NIH/OMB) White | 2599 Participants | 28581 Participants | 25982 Participants |
| Region of Enrollment United States Midwest | 1203 Participants | 12206 Participants | 11003 Participants |
| Region of Enrollment United States Northeast | 253 Participants | 4973 Participants | 4720 Participants |
| Region of Enrollment United States South | 1616 Participants | 17899 Participants | 16283 Participants |
| Region of Enrollment United States West | 445 Participants | 6215 Participants | 5770 Participants |
| Rural Non-Urban | 258 Participants | 2750 Participants | 2492 Participants |
| Rural Urban | 3259 Participants | 38543 Participants | 35284 Participants |
| Sex: Female, Male Female | 2130 Participants | 25283 Participants | 23153 Participants |
| Sex: Female, Male Male | 1387 Participants | 16000 Participants | 14613 Participants |
| Substance Use Disorder Flag No Evidence of Substance Use Disorder | 2879 Participants | 34372 Participants | 31493 Participants |
| Substance Use Disorder Flag Substance Use Disorder | 638 Participants | 6921 Participants | 6283 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3,517 | 0 / 37,776 |
| other Total, other adverse events | 0 / 3,517 | 0 / 37,776 |
| serious Total, serious adverse events | 0 / 3,517 | 0 / 37,776 |
Outcome results
Emergency Department Visits Among Patients With Bipolar Disorder
Mean number of annual emergency department visits in the follow-up period among bipolar patients
Time frame: Year 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-Deductible Health Plan Group | Emergency Department Visits Among Patients With Bipolar Disorder | 0.42 ED visits per year | Standard Deviation 1.26 |
| Control Group | Emergency Department Visits Among Patients With Bipolar Disorder | 0.38 ED visits per year | Standard Deviation 1.09 |
Inpatient Hospitalizations Among Bipolar Patients
Mean number of annual inpatient hospitalizations in the follow-up period among bipolar patients
Time frame: Year 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-Deductible Health Plan Group | Inpatient Hospitalizations Among Bipolar Patients | 0.17 hospitalizations per year | Standard Deviation 0.6 |
| Control Group | Inpatient Hospitalizations Among Bipolar Patients | 0.17 hospitalizations per year | Standard Deviation 0.57 |
Medication Adherence for Bipolar Disorder
Mean number of annual bipolar medication fills in the follow-up period among bipolar patients
Time frame: YEAR 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-Deductible Health Plan Group | Medication Adherence for Bipolar Disorder | 0.57 Medication fills per year | Standard Deviation 3.15 |
| Control Group | Medication Adherence for Bipolar Disorder | 1.42 Medication fills per year | Standard Deviation 4.47 |
Access To Outpatient Services for Bipolar Disorder
Mean number of annual outpatient mental health visits for bipolar patients, averaged across baseline and follow-up periods
Time frame: YEAR 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-Deductible Health Plan Group | Access To Outpatient Services for Bipolar Disorder | 5.54 visits per year | Standard Deviation 8.48 |
| Control Group | Access To Outpatient Services for Bipolar Disorder | 6.15 visits per year | Standard Deviation 9.54 |
Medication Adherence for Bipolar Disorder - Psychotropic Medications
Mean number of annual psychotropic medication fills in the follow-up period among bipolar patients
Time frame: YEAR 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-Deductible Health Plan Group | Medication Adherence for Bipolar Disorder - Psychotropic Medications | 0.73 medication fills per year | Standard Deviation 3.73 |
| Control Group | Medication Adherence for Bipolar Disorder - Psychotropic Medications | 2.57 medication fills per year | Standard Deviation 6.92 |
Annual Patient Out-of-pocket Costs for Patients With Bipolar Disorder
Annual patient out-of-pocket costs (paid deductible, coinsurance, and copayment amounts) for patients with Bipolar Disorder in the baseline period
Time frame: YEAR 2, YEAR 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-Deductible Health Plan Group | Annual Patient Out-of-pocket Costs for Patients With Bipolar Disorder | 1674.61 U.S. Dollars per year | Standard Deviation 1576.04 |
| Control Group | Annual Patient Out-of-pocket Costs for Patients With Bipolar Disorder | 1440.45 U.S. Dollars per year | Standard Deviation 1510.86 |