All the CMS cooks are back in the kitchen: What’s on the regulatory menu?

All the CMS cooks are back in the kitchen: What’s on the regulatory menu?

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October 30, 2025 – For those of you who haven’t heard the news, the Centers for Medicare & Medicaid Services (CMS) was able to find funding through research user fees to bring back all of its staff starting this Monday (October 27) in the midst of the ongoing government shutdown. While many CMS staff were already considered excepted and were working on key policy priorities (including some regulations), now that all the CMS cooks are back in the kitchen, CMS may be able to work on even more initiatives and policy areas despite the shutdown. It is still unclear if CMS can function as it normally does, but CMS will have all its staff in place to be able to focus on the critical work that the agency does on behalf of millions of Americans.

Some key deadlines are coming up. Open enrollment for the Affordable Care Act (ACA) Exchanges opens on November 1, 2025, and state applications for the Rural Health Transformation Program are due on November 5, 2025. Open enrollment for Medicare is also ongoing. Although staff working on these activities could be excepted during the shutdown, having staff in place from all CMS support functions, including budget, grants management, and communications, will help ensure a smooth rollout. There are a lot of cooks in the kitchen when it comes to operating government programs, and furloughing even some of them could impact the quality of the meal.

On the regulatory side, CMS may be able to start meaningfully working through the rules that stakeholders have been expecting. Some rules are statutorily required, and CMS has continued to work on them during the shutdown, while others are not explicitly required by law. Here are some key rules we’ve been tracking (many of which were included in the Trump administration’s spring unified agenda).

Statutorily required rules

• Calendar year (CY) 2016 Medicare payment final rules. By law, the CY 2026 final Medicare payment rules must be released by November 1, 60 days prior to the start of the calendar year. These final rules include the following:
  • End-Stage Renal Disease Prospective Payment System
  • Home Health Prospective Payment System
  • Physician Fee Schedule (PFS)
  • Outpatient Prospective Payment System (OPPS)

Stakeholders have been inquiring whether the rules will come out on time or be delayed because of the shutdown. While all of the rules are now with the Office of Management and Budget (OMB) for review, it remains to be seen when they will be released. OMB is the last stage of the internal government clearance process, but there is no minimum or maximum amount of time that a rule can be in this stage before it is issued. Now that all of CMS is back, there could be a slightly greater chance that the rules will come out relatively on time (October 31 is a Friday and November 3 is a Monday for those of you paying attention!) However, there is also a chance that some of the rules could be delayed several days or weeks.

Regardless of when the rules are released, having all the cooks in the kitchen could allow CMS to simultaneously release fact sheets and press releases that help explain the rules as the agency typically does (it was unclear before if there would be fact sheets and press releases for these rules during the government shutdown).

These Medicare payment rules have major implications for stakeholders. As discussed in previous Regs & Eggs blog posts, CMS received thousands of comments on the PFS and OPPS proposed rules. Proposals such as the efficiency adjustment and indirect practice expense reallocations in the PFS proposed rule and the site neutral and site-neutral-lite proposals in the OPPS rule are complicated, and it’s important for all the regulatory cooks at CMS to be actively involved in reviewing the comments and shaping the final policies.

• Medicare and Medicaid Programs; Repeal of Minimum Staffing Standards for Long-Term Care Facilities. This interim final rule, currently at OMB for review, will unwind the staffing requirements implemented by the Biden administration. The One Big Beautiful Bill Act (OBBBA) delayed implementation, administration, and enforcement of most of the Biden rule’s provisions through September 30, 2034.
• Medicare premium notices for CY 2026. CMS by law must set premium and deductible rates for Medicare Part A (including inpatient services) and Part B. Stakeholders are waiting to see whether Medicare cost-sharing amounts will rise in 2026, and if so, by how much. These notices are currently at OMB for review.
• Notice of Benefit and Payment Parameters for 2027. This rule proposes payment rates and policies for the ACA Exchanges for 2027. While the target date is November 2025, the rule is not yet in OMB clearance, so it is unclear when it will be released.
• 2027 Medicare Advantage and Part D rate notice. As explained in a previous Regs & Eggs blog post, when it comes to Medicare Advantage (MA), the annual advance and final rate notices are the only regulatory items with statutory deadlines. At least 60 days prior to the first Monday in April, CMS must put out an advance notice of proposed payment rates and policies that MA plans must adhere to when submitting bids for the coming year. CMS must give stakeholders at least 30 days to review and comment. By the first Monday in April each year, CMS must put out the final notice establishing these payment rates and policies. That way, MA plans have enough time to review the final rates and policies before bids are due on the first Monday in June.

Other expected rules

Most of the following rules are not statutorily required, so it’s unclear where they fall in the regulatory queue, whether CMS has been (or will be) working on them in any capacity during the shutdown, and when they might be released.

• CMS Innovation Center models. Three proposed rules are at OMB for review:
  • Center for Medicare & Medicaid Innovation Payment Models
  • Global Benchmark for Efficient Drug Pricing (GLOBE) Model
  • Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model

While it is unclear what the first model rule will propose, both the GLOBE Model and the GUARD Model may carry out the administration’s most favored nation policy. GLOBE may impact payments for Medicare Part B drugs (GLOBE for Part B) and GUARD may affect Part D drug payments (GUARD for Part D). Since they are to be proposed in rules, it is expected that the models will mandate participation in some way. However, most of the details of the models, including their scope and structure, will remain unknown until the rules are released.

CMS Innovation Center staff were not furloughed during the shutdown so they may have continued to work on the rules in the first few weeks of the shutdown.

• Medicaid rules. Two Medicaid proposed rules are at OMB for review:
  • Medicaid Managed Care State Directed Payments. This proposed rule could carry out an executive order that called on CMS to limit state-directed payment rates to the Medicare rate. It could also implement Section 71116 of OBBBA, which calls on CMS 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. There is no statutory deadline listed on OMB’s website for when the rule must be released.
  • Medicaid Program; Prohibition on Federal Medicaid Funding for Sex Trait Modification Procedures Furnished to Children and Youth. There is no description of the proposed rule on OMB’s website, but the title implies that it would seek to limit the use of Medicaid funding for certain procedures on children.
• Medicare conditions of participation. This proposed rule, titled Medicare and Medicaid Programs; Hospital Condition of Participation: Limiting Participation Based on the Performance of Sex Trait Modification Procedures on Children, has been at OMB since August 7, 2025 (before the shutdown started).
• 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 proposed rule would likely carry out some parts of this executive order.

• Contract Year 2027 Policy and Technical Changes to Medicare Advantage, Medicare Prescription Drug Benefit, Medicare Cost Plan, and Programs of All-Inclusive Care for the Elderly Programs. This rule, currently at OMB for review, would propose policy changes for MA and Part D for contract year 2027.
• Ensuring Safety through Domestic Security with Made in America Personal Protective Equipment (PPE) and Essential Medicine Procurement by Medicare Providers and Suppliers. As described on OMB’s website, this rule would “detail program incentives and requirements for Medicare providers and suppliers to invest and phase-in the procurement of American made personal protective equipment (PPE) and essential medicine to secure our nation’s health and safety.”
• Amendments to Rules Governing Organ Procurement Organizations. This proposed rule could include changes and clarifications to the competition and decertification process for organ procurement organizations. It is at OMB for review.
• No Surprises Act (NSA). The Trump administration is working on a couple of rules related to the NSA:
  • Independent Dispute Resolution (IDR) Operations. This rule, initially proposed in October 2023, would make improvements to the IDR process, update IDR fees, and institute new requirements around batching disputes.
  • Requirements Related to Advanced Explanation of Benefits and Other Provisions Under the Consolidated Appropriations Act 2021. The NSA requires health plans to send enrollees an advanced explanation of benefits (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. While the NSA established an implementation deadline for the AEOB provision of January 1, 2022, the federal government has repeatedly delayed its implementation because of technical and operational challenges. Thus, although the rule is technically statutorily required, since it’s already been delayed nearly four years, there is no longer a practical statutory deadline that CMS is planning to meet.
• Interoperability Standards and Prior Authorization for Drugs. This proposed 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 US Department of Health and Human Services (HHS) 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 fiscal year 2026 Inpatient Prospective Payment System final rule.

These are a lot of rules to keep track of, so here is a table that lays them all out:

All in all, rules that are statutorily required will continue to be prioritized, and CMS will try its best to get those out on time or as soon as possible. However, even with all the CMS cooks back the kitchen, the timing for all the rules, even those statutorily required, remains up in the air. Beyond CMS, other HHS cooks typically get involved in the regulatory review and clearance process, and some of these cooks have, and will continue to be, furloughed for the remainder of the government shutdown.

Until next week, this is Jeffrey saying, enjoy reading regs with your eggs.

For more information, please contact Jeffrey Davis. To subscribe to Regs & Eggs, please CLICK HERE.

Authors

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Jeffrey Davis

Washington, DC

Email / +1 (202) 204-1467
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