III. Undertaking the Initial Retrospective Review
As the first task in the regulatory review, HHS has already asked each agency to inventory its existing, significant regulations to provide information that will assist the Department in structuring an ongoing retrospective review process. Specifically, each agency initially reviewed its existing regulations to develop a proposed list of regulations the agency expected to review over the course of the next two years. HHS then took the agencies individual lists to compile the list of regulations proposed for review and identified in this Plan, including the chart of regulations in Appendix A.
On an ongoing basis, HHS receives suggestions about what regulations need review and possible change. Many of these suggestions come through correspondence, meetings with stakeholders, town hall meetings, public comment on proposed and final regulations, and other activities. Some of these suggestions resulted in the agency determinations about which regulations would be good candidates for a retrospective review in accordance with this retrospective review Plan. HHS has also received suggestions through public comment on this Plan. Those suggestions were shared with the agencies for consideration when revising this Plan and will be used in future regulatory review and development activities. HHS will continue to receive suggestions through these traditional avenues, as well as through various internet portals as it develops its broader regulatory reform capacity over the next few years.
For the initial retrospective review, existing resources do not allow the Department to undertake a detailed analysis on each regulation proposed for review, so the priority was first, to identify regulations that agencies could easily modify, streamline, or rescind to address regulatory burdens or inefficiencies, and second, to identify regulations that may be ripe for review because of changes in circumstance. These proposed candidates for review were then divided into categories in accordance with the guidelines set forth by the President in Executive Order 13563, including those candidate regulations that:
- Require updating in recognition of changing technology;
- May be revised to reduce the reporting and recordkeeping burdens;
- Can be cleaned up to eliminate outdated provisions; or
- Can be modified to increase flexibility and reduce burdens on states.
Integrating Regulatory Analysis into the Retrospective Review Process
For those regulations undergoing an extensive and thorough review, the Department will assist agencies in conducting a sound regulatory analysis to determine whether the regulatory activity is meeting the original objectives or whether an alternative, less prescriptive activity would achieve the same result. In the latter case, the Department will explore other alternatives, including the use of guidelines, incentives, public disclosure, and similar non-regulatory measures that might be used to achieve the same outcome as prescriptive regulations. In addition, the Department will also consider how regulations might be designed and written in ways that facilitate evaluation of their consequences and thus promote retrospective analyses and the measurement of actual results. For example, it may consider the use of experimental or quasi-experimental designs, including randomized controlled trials, when promoting the empirical testing of the effects of rules. Two examples are given immediately below.
Evaluating Regulatory Effectiveness
A good and comprehensive process of retrospective review must contain an evaluation component – a way to evaluate whether the regulation is effective in curbing the behavior it seeks to minimize or in providing incentives for behavior it seeks to enhance. HHS often includes a process for evaluation within a regulation, including two recent regulations:
- Graphic Warning Labels on Cigarette Packs – Integrated into the final rule is a process for evaluating the effectiveness of these Warning Labels at conveying the negative health consequences of smoking, delaying the onset of smoking, and ultimately reducing morbidity and mortality from smoking.
- Accountable Care Organizations (ACOs) – Integrated into the proposed rule are ongoing quality and performance measures for health care service providers participating in Medicare as ACOs, against which CMS will evaluate such organizations to help it determine whether the ACO is eligible for shared savings. Additionally, the Center for Medicare and Medicaid Innovation (CMMI) is statutorily required to evaluate its projects, including its testing of alternate payment models other than those outlined in the proposed rule. The vision is that the CMMI may be helpful in identifying alternative payment models as ACO efforts move forward. If successful, these alternatives may be permitted under revised regulations for ACOs.