Regulatory Impact Analysis

This guidance, originally published in 2003, contains the following introduction:

The U.S. Department of Health and Human Services (HHS) analyzes the benefits, costs, and other impacts of significant proposed and final rulemakings, consistent with the requirements of several executive orders and statutes. HHS develops these analyses according to technical guidance published by the U.S.

In 2016, the U.S. Department of Health and Human Services finalized its Guidelines for Regulatory Impact Analysis under the leadership of its Assistant Secretary for Planning Evaluation and Analytics Team. The Guidelines discuss strategies for characterizing the uncertainty in quantified effects as well as the potential impacts of non-quantified effects.

This report extends the brief discussion of addressing international effects contained in the Department of Health and Human Service Guidelines for Regulatory Impact Analysis (2016). The purpose of this supplement is to expand that discussion and provide more detailed information on conducting such assessments. Related Products:

This report develops an approach for valuing COVID-19 mortality and morbidity risk reductions based on the U.S. Department of Health and Human Services (HHS) Guidelines for Regulatory Impact Analysis. Valuing risk reductions associated with regulations or other policies that address the novel coronavirus disease 2019 (COVID-19) presents major challenges.

The purpose of this study is to describe and document changes states have made to their Medicaid or other publicly-funded consumer directed home care programs for seniors and individuals with disabilities to comply with the 2013 update to Fair Labor Standards Act (FLSA) regulations.

There are multiple pathways to becoming dually eligible for Medicare and Medicaid. The purpose of this study is to identify the frequency with which these pathways are followed and the beneficiary characteristics and patterns of service use by pathway.

The U.S. Department of Health and Human Services (HHS) is required to assess the benefits and costs of its major regulations prior to promulgation. To support these assessments, in 2016 HHS issued its Guidelines for Regulatory Impact Analyses, developed under the leadership of its Office of the Assistant Secretary for Planning and Evaluation and its Department-wide Analytics Team.

Regulatory impact analyses (RIAs) apply a well-established and widely-used framework for collecting, organizing, and evaluating data on the anticipated consequences of alternative policies.