Recommendation: Depending on the outcome of the litigation, the Secretary of Labor should take steps to ensure the agency will be positioned to conduct a meaningful retrospective review consistent with the Executive Order at an appropriate time. These steps should be taken in consultation with the Centers for Medicare & Medicaid Services, and could include, for example, identifying metrics that could be used to evaluate the rule, and implementing a plan to gather and analyze the necessary data.

Agency: Department of Labor
Status: Open

Comments: The Department of Labor's Wage and Hour Division (WHD) agreed with this recommendation and reported that it is working to develop data collection plans and explore a potential evaluation that is focused on the Home Care Rule. As part of this effort, WHD noted that it will continue to work with HHS and other federal partners. In FY16, WHD reported that such an evaluation of how stakeholders and affected industries have responded to the rule would be beneficial. However, litigation has delayed implementation and enforcement of the rule significantly, and WHD believes an evaluation at this stage would be premature and would be unlikely to fully and accurately capture stakeholders' responses to the rule and the resulting impacts. Delaying the evaluation would allow WHD to monitor the results of its own investigations and the effects of ongoing compliance assistance, both of which would be extremely difficult to measure at this early stage. In 2017, WHD reported that it will continue to monitor early implementation to determine the appropriate start for any evaluation and lay the groundwork for future assessment, including a plan for how to identify data that would inform such as an assessment. In 2018, WHD reported that it is too early in the implementation phase of the rule to conduct an evaluation of the rule's impact. The Department and WHD continue to engage with HHS to understand stakeholders' responses to the rule. WHD also continues to lay the groundwork for any future assessment by working to identify data sources that would inform such as an assessment.

Recommendation: To help states identify and address quality-of-care concerns among individuals with developmental disabilities receiving Medicaid HCBS waiver services, the Administrator of CMS should encourage states to (1) include death as a critical incident and conduct mortality reviews if they do not already do so and (2) broaden their mortality review processes if they already include death as a critical incident and conduct mortality reviews.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: As of August 2020, CMS had taken some steps to address this recommendation but additional actions are needed to fully implement it. In June 2018 CMS issued a Medicaid update to states explaining that CMS strongly encourages them to include unexpected deaths in their definition of reportable critical incidents. CMS also stated in the update that states should conduct a preliminary review of all beneficiary deaths and investigations should focus on those deaths determined to be unexpected. Further, CMS has shared with states best practices for state mortality reviews that include, for example, the use of an interdisciplinary review committee and taking actions to address identified quality of care problems. CMS also developed a webinar training (Incident Management 101) to help states improve their incident management systems for the Medicaid HCBS waiver. The webinar outlines the key elements of building a comprehensive incident management system (e.g., establishing a process for conducting investigations of incidents, tracking and trending incidents to help prevent and mitigate incidents from occurring) and reiterates CMS's expectation that states identify and address unexplained deaths on an ongoing basis in order to meet the waiver's health and welfare assurance. In late 2018, CMS planned to include in its revised waiver application questions to determine practices regarding states' review and evaluation of unexpected deaths. In September 2019, CMS officials notified us that it will provide an updated status report on this recommendation in November 2019. As of August 2020, CMS officials have not provided us information regarding its revised waiver application and technical guide. We will update the status of this recommendation when we receive this information.