10-for-1 Deregulation Executive Order: Key Health Policy Issues to Watch

At a Glance

• The significance of the order to health care stakeholders will come into focus in the coming weeks, as it directs the Office of Management and Budget (OMB) to provide implementation guidance on key issues.
• The “10-for-1 order” symbolizes the intensity by which President Trump seeks to outdo his first term. Future implementing guidance from OMB, a potential new executive order on “significant” rulemaking, and the Spring 2024 Unified Regulatory Agenda will clarify some of what is to come from now until September 30.

On January 31, 2025, President Trump signed Executive Order 14192 which is formally titled, “Unleashing Prosperity Through Deregulation,” but could gain notoriety as the “10 for 1 Order.” The Order has several parallels to a January 30, 2017, Executive Order (E.O. 13771), but is intended to build on — and expand upon — the deregulatory agenda that was a key part of President Trump’s first term.

Like the 2017 Order, the 2025 Order imposes a two-fold regulatory performance metric for executive branch agencies, intended to reduce the volume and cost of regulations to promote fiscal responsibility and alleviate “unnecessary” regulatory burdens:

• First, for each regulation that is publicly proposed for notice and comment, or otherwise promulgated, by an individual executive department or agency, the agency “shall identify” at least 10 existing regulations to be repealed.
• Second, beginning with Fiscal Year 2025, the total incremental cost of all new regulations must be “significantly less than zero,” as determined by the Office of Management and Budget (OMB).

Significance of the 2025 Order

The significance of the Order to health care stakeholders will come into focus in the coming weeks, as it directs the Office of Management and Budget (OMB) to provide implementation guidance on key issues. We highlight a few of these issues we are analyzing below.

Regulation as a Unit Measure

Perhaps the most significant unknown about the Order is how the administration intends to define a “regulation” for purposes of calculating the 10-for-1 ratio. As a starting point, the 2025 Order defines a “regulation” or “rule” broadly. As would be expected, the Order applies to traditional rules promulgated through the standard rulemaking processes subject to the Administrative Procedure Act and more informal statements of general or particular applicability such as FDA guidance documents. However, the Order also applies to statements used to describe the procedure or practice requirements of an agency, which will be an easier target, especially for Department of Health and Human Services’ (HHS) program subregulatory guidance.

Given that rulemaking takes time, it would seem a decent portion of HHS’s implementation of the Order — at least in fiscal year 2025 — could come in the form of reduced administrative burdens through rollbacks of subregulatory guidance applicable to health providers, plans or drug manufacturers. For regulations, a key question is if a single “regulation” means an individual provision in the Code of Federal Regulations (e.g., a special enrollment period opportunity) or the bundle of provisions often part of a larger rulemaking vehicle published in the Federal Register (e.g., the annual Notice of Benefit and Payment Parameters) Moreover, the magnitude of any regulation varies significantly.

Timing

There are eight months remaining in Fiscal Year 2025, ending September 30, 2025, and many agency heads are just beginning to be installed in their posts following applicable U.S. Senate confirmation processes. This — combined with the current regulatory freeze order and the 2025 Order’s requirement for any regulation (unless required by law) to be included in the most recent version or update of the published Unified Regulatory Order — means that the agencies will be intentional, deliberate and perhaps more transparent about which regulations will be issued or repealed.

In addition, if congressional Republicans pursue a reconciliation package in fiscal year 2025, Congress may repeal or delay through legislation regulations that might otherwise be part of the executive branch’s “10-for-1” strategy. Congress may do so for multiple reasons, but particularly to achieve budgetary savings that could be used to pay for new spending, like extended or larger tax cuts. We saw this with the continued delay of the HHS Office of the Inspector General’s anti-kickback rebate rule safe harbor regulations through 2031 imposed by the Inflation Reduction Act of 2022, which was also passed through the reconciliation process. Coordination between the two branches on potential deregulatory targets — like the Centers for Medicare & Medicaid Services’ (CMS) nursing home staffing final rule — will be critical.

Interaction With Mandatory Programs and Regulations

Rules that are required by law are treated differently by the 2025 Order in important ways.

First, the traditional Medicare annual payment rules — such as the Inpatient Prospective Payment System (IPPS), Hospital Outpatient Prospective Payment System (OPPS), etc.; the Medicare Advantage Annual Notice; and other rules required by statute such as the ongoing rulemaking implementing parts of the Inflation Reduction Act’s Medicare Part D prescription drug reforms and the Consolidated Appropriations Act, 2021’s No Surprises Act provisions — are expected by the Trump administration. However, these large rulemaking vehicles could house multiple “deregulatory” actions. While Medicaid, like Medicare, is a mandatory spending program, the 10-for-1 order may provide additional policy rationale to roll back changes to several Medicaid regulations issued by the Biden administration that generally strengthen beneficiary protections and impose greater federal and state costs, at least in the short term.

Second, as a general matter, deregulatory or regulatory actions that are required by law could be exempt from the transparency requirements set forth in the Order, meaning that stakeholders may not receive a preview of unexpected actions via the Unified Regulatory Agenda, which usually comes out each spring and fall.

What’s Coming

The “10-for-1 order” symbolizes the intensity by which President Trump seeks to outdo his first term — even if it is impossible to make any apples-to-apples comparisons between “regulatory” and “deregulatory” actions and as foregone benefits of withdrawn or rolled back rules are not part of the 10:1 ratio. Future implementing guidance from OMB, a potential new executive order on “significant” rulemaking, and the Spring 2024 Unified Regulatory Agenda will clarify some of what is to come from now until September 30. Stay tuned.