NCT03602456

Evaluation of the Health and Economic Consequences of Kentucky's Section 1115 Demonstration Waiver

Terminated Last updated 5 February 2020

What this trial tests

trial testing Kentucky HEALTH in Health Insurance in 378,828 participants. Terminated before completion.

Timeline

1 April 2018

Primary endpoint
16 December 2019

16 December 2019

Quick facts

Lead sponsor	University of Pennsylvania
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	378,828
Start date	1 April 2018
Primary completion	16 December 2019
Estimated completion	16 December 2019
Sites	2 locations across United States

Drugs / interventions tested

• Kentucky HEALTH

Conditions studied

• Health Insurance — all drugs for Health Insurance →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 64, any sex, with Health Insurance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Kentucky HEALTH was an 1115 Medicaid waiver that was approved by the Centers for Medicare and Medicaid Services (CMS) in January 2018. In what was initially planned to be a 5-year demonstration, KY HEALTH aimed to modify the traditional Medicaid program to improve health behaviors, health outcomes, and socioeconomic outcomes in the waiver-eligible population through several innovations. In brief, these included introducing Community Engagement requirements (i.e. work requirements), monthly premiums, MyRewards accounts for dental and vision services, and annual recertification. If beneficiaries failed to complete these requirements, some penalties included suspension and 6-month lockouts from the Medicaid program.

The Commonwealth of Kentucky had chosen to implement this program in a randomized fashion, where 10% of the target population was randomly assigned to continue receiving traditional Medicaid while 90% would receive Kentucky HEALTH benefits and be subject to the requirements discussed above. Randomization was conducted by the state, through their separate contract with a non-profit research firm (National Opinion Research Center, NORC). The NORC also engaged in primary data collection to support the analysis of the project. The University of Pennsylvania team served as the non-partisan, independent evaluators of this randomized intervention conducted by the Commonwealth of Kentucky. The analysis would measure the impact of KY HEALTH compared to traditional Medicaid.

Due to ongoing legal challenges and a change in administrations, the implementation of Kentucky HEALTH was delayed and eventually cancelled. On March 27, 2019, the DC District Court Judge concluded that the approvals did not address how the requests would align with Medicaid's core objectives. At that point, data collection was ongoing although Kentucky HEALTH was delayed until further notice. Kentucky's 2019 gubernatorial election took place on November 5th and resulted in the election of a new governor. On December 16, 2019, a termination request was sent to CMS as a notification of the new administration's intention to cancel Kentucky HEALTH. On December 18, 2019, a clarification letter was sent to CMS to notify them that the termination did not apply to the SUD program and NEMT portion (among others) of the waiver. While the Penn team will continue conducting a separate evaluation of the ongoing SUD program, the randomized controlled trial and data collection described in this study will end with the terminated components of the waiver.

As a result of the legal challenges, the implementation of Kentucky HEALTH was delayed before being cancelled altogether. The study start and end dates above reflect the beginning of data collection and the termination letter that was sent to CMS, respectively.

A total of 9,396 surveys (KHES), 127 beneficiary semi-structured interviews, and 40 provider interviews were conducted.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The design of a randomized controlled trial to evaluate multi-dimensional effects of a section 1115 Medicaid demonstration waiver with community engagement requirements.
   Linn KA, Underhill K, Dixon EL, Bair EF, et al · · 2020 · cited 1× · PMID 33038505 · DOI 10.1016/j.cct.2020.106173