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August 28, 2025 – For some of us (like me and my colleague Kristen O’Brien), this week marks the end of summer vacation and the return to school for our children. One set of questions we typically get from our kids is about the lunch menu: Has it changed from last year? Is there anything new on the menu? Is my school finally going to start serving McDonalds? While school menus are now set (and therefore we should be able to answer those important questions for our kids), the same cannot be said about the federal regulatory “menu.”
This menu, called the unified agenda, usually is released twice a year, in the spring and fall. The Trump administration has yet to release one formally; the last unified agenda was released under the Biden administration in fall 2024. Although we don’t know what items will wind up on the Trump administration’s regulatory menu, the administration has been busy putting out rules, and we know that they are working on releasing more.
Some items on the regulatory menu don’t ever change (“the usual,” so to speak). For example, we have already witnessed the Centers for Medicare & Medicaid Services (CMS) issue many Medicare payment rules (for physicians, hospitals, various facilities, and Medicare Advantage and Medicare prescription drug plans). We also have a window into what rules are about to be released through the Office of Management and Budget’s (OMB’s) Office of Information and Regulatory Affairs (OIRA) website. As we described in a previous Regs & Eggs blog post, OIRA is responsible for handling the White House clearance for rules, which is the final stage in the federal government’s internal clearance process before a rule is released publicly. When a rule reaches this stage, it appears on OIRA’s Executive Order Submissions Under Review web page. Once the White House clears the rule, it is removed from that site and appears on the Executive Order Submissions with Review Completed in Last 30 Days web page. This effectively means that the rule could be released on the Federal Register at any time.
Thus far, the administration has released about 25 healthcare-related rules, including the Medicare rules that we all expected to see. Notable rules besides “the usual” have included an Affordable Care Act program integrity rule, a proposed rule aimed at closing a healthcare-related tax loophole for the Medicaid population, and most recently, a proposed rule that could affect eligibility for student loan forgiveness (which impacts medical students).
We are also keeping an eye out for some key rules that are at the White House review stage. OMB’s website is currently undergoing revisions, and therefore this portion of the menu may not be complete. OMB has been trying to update the menu daily through a PDF document listing the names of the rules in White House clearance. These include:
- A CMS notice called “Medicaid Eligibility Changes Under the Affordable Care Act of 2010; Giving States Freedom to Use Immigration Information to Determine State Residency for Medicaid Eligibility.” OMB’s website includes no description besides the title, but the notice may attempt to give states more leeway to use information regarding individuals’ immigration status to determine Medicaid eligibility.
- A CMS proposed rule called “Medicaid Managed Care-State Directed Payments,” which could carry out an executive order that called on CMS to limit state-directed payment rates at the Medicare rate. It could also implement Section 71116 of the One Big Beautiful Bill Act (OBBBA), which calls on CMS to modify current regulations to cap the state-directed payment ceiling for certain services at 100% of the total published Medicare payment rate in Medicaid expansion states, and at 110% in non-expansion states.
- A CMS proposed rule called “Medicaid Program; Prohibition on Federal Medicaid Funding for Sex Trait Modification Procedures Furnished to Children and Youth.” There is no description of the rule on OMB’s website, but the title implies that the rule would seek to limit the use of Medicaid funding for certain procedures on children.
- A CMS final rule called “Contract Year 2026 Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, and Medicare Cost Plan Programs, and PACE.” This title may look familiar, as CMS already released a Contract Year 2026 Medicare Advantage and Part D final rule. This second final rule could finalize policies that were previously proposed but not addressed in the first final rule.
- A CMS proposed rule that could add new Medicare and Medicaid conditions of participation that prohibit hospitals and facilities from providing certain gender-affirming care procedures for minors. This rule initially appeared on OMB’s website, was temporarily removed, then was put back on the separate PDF document. Specific details about the rule remain unclear.
- A CMS rule called the “Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting,” which would likely unwind the staffing requirements implemented by the Biden administration. The OBBBA delayed implementation, administration, and enforcement of most of the Biden rule’s provisions through September 30, 2034.
- A CMS rule called “Amendments to Rules Governing Organ Procurement Organizations.” This rule could institute changes and clarifications to the competition and decertification process for organ procurement organizations.
- A CMS rule called “Transparency in Coverage.” As discussed in this Regs & Eggs blog post, President Trump issued a price transparency executive order in February 2025 that called on federal agencies to promulgate regulations that would:
- Require disclosure of actual prices of items and services, not estimates.
- Ensure that pricing information is standardized and easily comparable across hospitals and health plans.
- Update enforcement policies designed to ensure compliance with the transparent reporting of complete, accurate, and meaningful data.
This rule would likely carry out some parts of this executive order.
- A CMS rule called “Center for Medicare & Medicaid Innovation Payment Models.” No additional details about the rule are available in the PDF document, so it is unclear whether this rule would implement one or more mandatory models (which must go through rulemaking) or make more general changes to the process the CMS Innovation Center employs to develop or implement models.
- A US Drug Enforcement Administration final rule called “Emergency Medical Services (EMS),” which implements the Protecting Patient Access to Emergency Medications Act of 2017. This law modified how EMS professionals can administer controlled substances to individuals receiving emergency medical services. The proposed rule was issued in 2020, and if finalized as proposed, the rule would authorize EMS professionals to administer controlled substances outside the physical presence of a medical director or authorizing medical professional through standing or verbal orders.
Beyond these, notable items that could still be added to the menu include:
- No Surprises Act (NSA) rules. The Biden administration’s unified agenda included a few NSA rules that the Trump administration may decide to take on, including the following:
- The independent dispute resolution (IDR) operations final rule: The rule, initially proposed in October 2023, would make improvements to the IDR process, update IDR fees, and institute new requirements around batching disputes.
- Implementing the Advanced Explanation of Benefits (AEOB) requirement: The NSA requires health plans to send enrollees an AEOB notification for certain services that includes a good faith estimate of the amount the plan is responsible for paying and the amount of any cost sharing for which the individual is responsible. The federal government has implemented the law’s good faith estimate requirement for individuals without insurance but has not implemented the good faith estimate and AEOB requirements for individuals with insurance. The Trump administration could propose a rule to implement those requirements.
- Interoperability Standards and Prior Authorization for Drugs proposed rule. This rule appeared in the Biden administration’s unified agenda but may align with the Trump administration’s goal to streamline prior authorization processes. The rule would apply some of the same prior authorization requirements that the CMS Interoperability and Prior Authorization final rule established for medical services to drugs as well (as a significant number of public commenters urged CMS to do). The Department of Health and Human Services published some standards on prior authorization under the Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization (HTI-4) final rule, which was embedded in the Inpatient Prospective Payment System final rule.
This is just a taste of the items that are on, and could still be added to, the Trump administration’s regulatory menu. No matter what rules end up being put on the menu, don’t forget to add a side of Regs & Eggs, a tasty complement to any healthcare rule.
Until next week, this is Jeffrey (and Kristen) saying, enjoy reading regs with your eggs.
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