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The design of a randomized controlled trial to evaluate multi-dimensional effects of a section 1115 Medicaid demonstration waiver with community engagement requirements.

ABSTRACT: Section 1115 demonstration waivers provide a mechanism for states to implement changes to their Medicaid programs. While such waivers are mandated to include evaluations of their impact, randomization - the gold standard for assessing causality - has not typically been a consideration. In a critical departure, the Commonwealth of Kentucky opted to pursue a two-arm randomized controlled trial (RCT) for their controversial 2018 Medicaid Demonstration waiver, which included work requirements as a condition for the subset of beneficiaries deemed able-bodied to maintain eligibility for benefits. Beneficiaries were randomized 9:1 to the new waiver program or a control group who would retain their current benefits as part of the existing Medicaid expansion program. To address potential bias from differential attrition from the Medicaid program that would accrue from solely analyzing administrative data, our team designed a rich, prospective, longitudinal survey to collect primary and secondary outcomes from six categories of interest to policymakers: insurance coverage, health care utilization and quality, health behaviors, socioeconomic measures, personal finances, and health outcomes. At baseline, a subset of survey participants was invited to participate in the collection of biometric samples via in-person follow-up visits, and a cross-section were also invited to participate in qualitative interviews. While the demonstration waiver was terminated before the program began, our study design illustrates that it is possible for other researchers and state agencies seeking to evaluate Medicaid demonstration waivers and other demonstration policies to work together to implement high quality randomized trials - even for controversial policies.

SUBMITTER: Linn KA

PROVIDER: S-EPMC7538873 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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The design of a randomized controlled trial to evaluate multi-dimensional effects of a section 1115 Medicaid demonstration waiver with community engagement requirements.

Linn Kristin A KA Underhill Kristen K Dixon Erica L EL Bair Elizabeth F EF Ferrell William J WJ Montgomery Margrethe E ME Volpp Kevin G KG Venkataramani Atheendar S AS

Contemporary clinical trials 20201007

Section 1115 demonstration waivers provide a mechanism for states to implement changes to their Medicaid programs. While such waivers are mandated to include evaluations of their impact, randomization - the gold standard for assessing causality - has not typically been a consideration. In a critical departure, the Commonwealth of Kentucky opted to pursue a two-arm randomized controlled trial (RCT) for their controversial 2018 Medicaid Demonstration waiver, which included work requirements as a c ...[more]

PMID: 33038505

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Project description:ImportanceStates are pursuing Section 1115 Medicaid demonstration waiver authority to apply community engagement (CE) requirements (eg, participation in work, volunteer activities, or training) to beneficiaries deemed able-bodied as a condition of coverage. Understanding the size and characteristics of the populations included in these requirements can help inform policy initiatives and anticipate effects.ObjectiveTo estimate the number and characteristics of Kentucky Medicaid beneficiaries who would have to meet CE requirements.Design, setting, and participantsCross-sectional study in which administrative records for the entire population of Medicaid beneficiaries in Kentucky as of February 2018 and original survey data, based on responses from 9396 Medicaid beneficiaries included in the waiver program, were analyzed.ExposuresEligibility for Kentucky's Medicaid demonstration waiver as of the originally planned implementation date (July 2018).Main outcomes and measuresNumber of beneficiaries included in CE requirements, including those already meeting vs not meeting hour quotas and those who may qualify for medical frailty exemptions.ResultsAmong the 9396 individuals included in the Section 1115 waiver program who participated in the survey, the mean weighted (SD) age was 36.1 (11.9) years; a weighted 47.2% of respondents were female, and most beneficiaries (weighted percentage, 78.2%) were non-Hispanic white participants. We estimated that 132 790 (95% CI, 129 132-136 449) beneficiaries would have been required to meet CE requirements in July 2018, amounting to 40.2% of Medicaid beneficiaries included in the demonstration waiver. Of this group, 25 422 (95% CI, 23 135-27 710) beneficiaries may have qualified for a medical frailty exemption either by self-attestation (after confirmation by their Medicaid insurer) or by being identified as eligible by physicians or their insurer. Another 58 943 (95% CI, 55 687-62 196) beneficiaries likely would have met CE hour requirements and been required to report compliance. Ultimately, 48 427 (95% CI, 45 281-51 574) individuals would have had to add new activities to meet CE requirements, amounting to 14.7% of those included in the demonstration waiver as a whole and 36.3% of those included in the CE component of the waiver. Beneficiaries in the potentially medically frail group reported worse socioeconomic status, poorer health outcomes, and higher rates of hospital admission and emergency department use than those meeting CE requirements. Similarly, the group currently not meeting and not exempt from CE hour requirements reported worse socioeconomic status than those meeting the CE requirements, although magnitudes of the differences were smaller.Conclusions and relevanceFindings suggest that most beneficiaries who would be included in CE programs either already meet activity requirements, which they will be required to proactively report, or may qualify for a medical frailty exemption. Consequently, the outcomes of CE programs will depend on states' processes for addressing health-related, socioeconomic, and administrative barriers to participating in and reporting CE activities and identifying medical frailty.

Project description:ImportanceLocal-level data are needed to understand whether the relaxation of X-waiver training requirements for prescribing buprenorphine in April 2021 translated to increased buprenorphine treatment.ObjectiveTo assess whether relaxation of X-waiver training requirements was associated with changes in the number of clinicians waivered to and who prescribe buprenorphine for opioid use disorder and the number of patients receiving treatment.Design, setting, and participantsThis serial cross-sectional study uses an interrupted time series analysis of 2020-2022 data from the HEALing Communities Study (HCS), a cluster-randomized, wait-list-controlled trial. Urban and rural communities in 4 states (Kentucky, Massachusetts, New York, and Ohio) with a high burden of opioid overdoses that had not yet received the HCS intervention were included.ExposureRelaxation of X-waiver training requirements (ie, allowing training-exempt X-waivers) on April 28, 2021.Main outcomes and measuresThe monthly number of X-waivered clinicians, X-waivered buprenorphine prescribers, and patients receiving buprenorphine were each summed across communities within a state. Segmented linear regression models to estimate pre- and post-policy change by state were used.ResultsThe number of individuals in 33 participating HCS communities included 347 863 in Massachusetts, 815 794 in Kentucky, 971 490 in New York, and 1 623 958 in Ohio. The distribution of age (18-35 years: range, 29.4%-32.4%; 35-54 years: range, 29.9%-32.5%; ≥55 years: range, 35.7%-39.3%) and sex (female: range, 51.1%-52.6%) was similar across communities. There was a temporal increase in the number of X-waivered clinicians in the pre-policy change period in all states, which further increased in the post-policy change period in each state except Ohio, ranging from 5.2% (95% CI, 3.1%-7.3%) in Massachusetts communities to 8.4% (95% CI, 6.5%-10.3%) in Kentucky communities. Only communities in Kentucky showed an increase in the number of X-waivered clinicians prescribing buprenorphine associated with the policy change (relative increase, 3.2%; 95% CI, 1.5%-4.9%), while communities in other states showed no change or a decrease. Similarly, only communities in Massachusetts experienced an increase in patients receiving buprenorphine associated with the policy change (relative increase, 1.7%; 95% CI, 0.8%-2.6%), while communities in other states showed no change.Conclusions and relevanceIn this serial cross-sectional study, relaxation of X-waiver training requirements was associated with an increase in the number of X-waivered clinicians but was not consistently associated with an increase in the number of buprenorphine prescribers or patients receiving buprenorphine. These findings suggest that training requirements may not be the primary barrier to expanding buprenorphine treatment.

Dataset Information

The design of a randomized controlled trial to evaluate multi-dimensional effects of a section 1115 Medicaid demonstration waiver with community engagement requirements.

Publications

The design of a randomized controlled trial to evaluate multi-dimensional effects of a section 1115 Medicaid demonstration waiver with community engagement requirements.

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