McDermott+ 2026 healthcare preview: Key regulatory themes - McDermott+

McDermott+ 2026 healthcare preview: Key regulatory themes

McDermott+ 2026 healthcare preview: Key regulatory themes


McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey DavisClick here to subscribe to future blog posts.

January 22, 2026 – Earlier this week, we released a +Insight called “Healthcare in 2026: A preview” that lays out major legislative and regulatory healthcare actions that we expect to see in 2026. While Congress certainly has a lot on its plate, especially with January 30, 2026, continuing resolution deadline coming up and a new funding bill and healthcare package to consider, the administration will be equally busy on the regulatory side. As laid out in our +Insight, here are some of the key regulatory areas we are monitoring this year.

Implementation of the One Big Beautiful Bill Act


The One Big Beautiful Bill Act (OBBBA), signed into law on July 4, 2025, introduces significant changes to the healthcare landscape, with provisions impacting Medicaid, Medicare, the Affordable Care Act (ACA), and other healthcare programs. Implementation of significant OBBBA provisions is set to take place in 2026 and 2027, so the Centers for Medicare & Medicaid Services (CMS) will likely release regulations throughout 2026, including:

Subregulatory guidance, such as informational bulletins and state Medicaid director letters, also is expected.

OBBBA also created the Rural Health Transformation Program (RHTP), a five-year $50 billion program that awards funds to states to invest in transformational rural health initiatives. Under the law, $10 billion will be available each fiscal year (FY) from 2026 to 2030. On December 29, 2025, CMS announced that all 50 states received first-year awards. Award amounts ranged from $147 million to $281 million. CMS also launched the Office of Rural Health Transformation (ORHT) to oversee the RHTP, assist states in implementing their plans, provide technical assistance, and coordinate federal and state partnerships. Expect to hear more this year from the ORHT and from states directly regarding the implementation of their plans, including at the CMS Rural Health Summit scheduled for March 2026.

Medicare payment policies


During 2026, CMS will propose and finalize policies for 2027 for Medicare fee-for-service (FFS) providers and facilities and Medicare Advantage (MA) plans.

Regulations impacting Medicare FFS providers and facilities follow either FY or calendar year (CY) schedules.

Regulatory calendar Examples Proposed Finalized Effective date
FY Hospital inpatient, skilled nursing facility, and hospice payments Around April 2026 By August 1, 2026 October 1, 2026
CY Physician and hospital outpatient payments June or July 2026 By November 1, 2026 January 1, 2027

Some of these Medicare FFS payment regulations may expand upon policies and priorities that CMS included in the 2026 rulemaking cycle, such as:

  • Promoting payment accuracy and reducing fraud, waste, and abuse.
  • Reducing administrative burden through the introduction of deregulatory reforms.
  • Leveraging new technologies to improve chronic diseases.
  • Supporting primary care clinicians and other clinicians who deliver services in rural areas.
  • Enhancing Make America Healthy Again (MAHA) initiatives, including by encouraging nutrition education and adding wellness and nutrition measures to CMS quality programs.
  • Promoting site neutral and “site neutral lite” policies by continuing to phase out the inpatient only list and expanding the covered procedures list for procedures permitted in ambulatory surgery centers.

For MA, the 2027 rate notice cycle will begin with CMS’s release of the 2027 MA and Part D advance rate notice, expected by early February 2026. Key issues in the notice will include the size of the proposed increase to benchmark payment rates, given concerns about rising utilization and costs for payers, and whether CMS proposes changes to the risk adjustment model or methodology. CMS will finalize payment rates and policies for 2027 in early April 2026. CMS also is expected to finalize its November 2025 proposed policy and technical changes to the MA and Part D programs in advance of the 2027 bid deadline of June 1, 2026.

CMS Innovation Center models


In 2025, the CMS Innovation Center expanded its model portfolio, demonstrating an aggressive posture toward continued testing and incubation. The center released nine new models spanning multiple clinical domains, payment approaches, and participant types. We detailed many of these and other model developments in a recent Regs & Eggs blog post. 2026 will see the launch of many of these models, as well as additional model announcements.

Artificial intelligence and technology


The Trump administration began to articulate its artificial intelligence (AI) strategy at the end of 2025. On December 11, 2025, the White House issued an executive order (EO) attempting to restrict state-level AI laws. The administration’s stated goal is to maintain “global AI dominance” through a “minimally burdensome” framework. The EO sets out several measures and efforts in furtherance of the administration’s desire to avoid a patchwork of state laws and regulations, to reduce barriers to innovation, and to ensure consistent oversight of interstate commerce.

Several agencies are currently seeking stakeholder feedback on specific issues related to AI use in healthcare. For example, CMS has asked for comments on how to appropriately and adequately address Medicare reimbursement for the use of AI in healthcare through the annual Physician Fee Schedule (PFS). The US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) issued a request for information (RFI) in December 2025 asking for feedback on accelerating the use of AI in clinical care. Several models recently announced by the CMS Innovation Center also heavily emphasize the use of AI. In 2026, we should start to see how the administration will tackle these issues and whether stakeholder feedback will impact the direction of any new regulatory efforts.

On the technology front, ASTP is in the process of refining standards for what counts as “certified electronic health record technology” and heightening enforcement of information blocking requitements. At the end of 2025, ASTP issued a proposed rule, the Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity (HTI-5), which could be finalized this year. ASTP also published a separate notice withdrawing yet-to-be finalized proposals from the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule. Together, the proposed changes would reduce the circumstances under which actors may deny requests for access, exchange, or use of electronic health information (EHI), suggesting this administration will push to provide broader access to EHI.

Drug pricing


The Trump administration took many actions in 2025 on prescription drug pricing. One such action included negotiating price agreements directly with drug manufacturers. We expect to learn more about these agreements in 2026. President Trump also announced a new TrumpRx website intended to connect patients with direct-to-consumer purchasing programs offered by drug manufacturers. TrumpRx is expected to launch in January 2026. To date, nine drug manufacturers have agreed to offer some of their drugs at a reduced price when patients buy them directly from the manufacturer through TrumpRx. Negotiations with additional drug manufacturers are ongoing. These agreements are separate from agreements made with the same drug manufacturers to offer most-favored nation pricing to state Medicaid programs.

In 2026, the administration’s drug pricing strategy will move from policy to execution. In particular, the administration, through the CMS Innovation Center, will test a coordinated set of drug pricing models:

  • The Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) model pairs GLP-1 drug affordability (via negotiated rates) with lifestyle-modification and obesity-management programming to improve health outcomes. Manufacturers interested in participating in the model had to respond to the request for applications (RFA) by January 8, 2026. State Medicaid agencies and Part D plans also had to submit a notice of intent to participate by January 8, 2026. Medicaid coverage will begin as early as May 2026, while Part D coverage will occur in January 2027 (Part D beneficiaries are expected to have access to GLP-1s by July 2026 through a separate short-term Section 402 Medicare demonstration).
  • The Global Benchmark for Efficient Drug Pricing (GLOBE), Guarding US Medicare Against Rising Drug Costs (GUARD), and GENErating cost Reductions fOr US Medicaid (GENEROUS) models operationalize the administration’s most-favored nation (i.e., international reference pricing) framework across Medicare Part B, Medicare Part D, and Medicaid, respectively. These models target certain high-cost drugs whose US prices exceed international benchmarks. Because the GLOBE and GUARD models are mandatory for manufacturers, CMS had to go through notice-and-comment rulemaking. The comment period for the proposed rule closes on February 23, 2026. If finalized, GLOBE is expected to begin October 1, 2026, while GUARD would launch January 1, 2027. Manufacturers interested in participating in GENEROUS have until March 31, 2026, to submit a response to the manufacturer RFA, and states have until July 31, 2026, to respond to the state RFA.

President Trump also included drug pricing as one of his major policy priorities in his January 15, 2026, Great Healthcare Plan announcement. As part of the plan, he called on Congress to codify the most-favored-nation deals.

Private insurance reforms


Every year, CMS establishes policies for the Affordable Care Act (ACA) marketplace, and the agency will soon release the ACA proposed Notice of Benefit and Payment Parameters for 2027. This rule could focus on the Trump administration’s ongoing effort to crack down on perceived fraud and abuse within the marketplace, and explore ways to drive down health insurance premiums and out-of-pocket costs. It will be interesting to see if the rule references the Great Healthcare Plan, since the plan aims to drive down premiums by promoting policies that would send “money directly to eligible Americans to allow them to buy the health insurance of their choice.”

The administration also may finalize the Transparency in Coverage rule that was proposed in December 2025. The rule would impose on health plans new requirements that aim to improve the standardization, accuracy, and accessibility of information by addressing three main barriers to full price transparency:

  • Inaccessibility due to the large size of machine-readable files.
  • Data ambiguity due to a lack of contextual information.
  • Areas of misalignment with the hospital price transparency requirements that make comparing data across disclosures challenging.

Price transparency in general will remain a top priority, as the Great Healthcare Plan would also require certain health plans to publish:

  • Rate and coverage comparisons on their website in plain English.
  • The percentage of their revenues that are paid out to claims versus overhead costs and profits on their websites.
  • The percentage of insurance claims they reject and average wait times.
  • Prices and fees, to avoid surprise medical bills.

Congress may need to adopt these additional requirements, which cannot be included in the final Transparency in Coverage rule since they were not explicitly proposed.

MAHA


HHS Secretary Robert F. Kennedy, Jr., will likely continue to pursue MAHA policies to address chronic disease through lifestyle medicine and structural changes. In 2025, an EO created the MAHA Commission and directed the release of its first report, which focused on identifying key drivers of children’s declining mental and physical health, including poor diet, chemical exposure, lack of physical activity, chronic stress, and overmedicalization. The commission released its MAHA strategy later in the year. Several HHS policy initiatives throughout 2025 included MAHA priorities, and HHS likely will continue to find ways to implement the concept further in 2026.

CMS included several RFIs in formal rulemaking, signaling future action. In the CY 2026 Medicare PFS proposed rule, CMS sought feedback on expanded treatment options and flexibility for insurance coverage, as well as on benefits around lifestyle changes and disease prevention. Although CMS did not finalize specific policies related to the RFI, the topic will likely come up again in CY 2027 rulemaking. CMS also included an RFI on well-being and nutrition in the CY 2027 MA and Part D proposed rule. Comments are due on January 26, 2026. The CMS Innovation Center included MAHA initiatives in various models that will be implemented throughout 2026.

This month, HHS and the US Department of Agriculture (USDA) released revised dietary guidelines. The accompanying scientific review emphasized the need for a uniform definition of highly processed foods. A joint USDA and US Food and Drug Administration effort is underway to establish this definition and may see progress in 2026.


These are just some of the areas we are monitoring for 2026, and our +Insight goes into a lot more detail! Please give it a read, and feel free to reach out if you have any questions or want to discuss any issues further.

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


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