CMS Launches Five New Models at the End of 2025: Looks to Advance ACCESS, BALANCE, MAHA ELEVATE, GLOBE and GUARD in 2026

Background

The Centers for Medicare & Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (CMMI) (Innovation Center) has unveiled a series of new models related to the administration’s focus on improving the health of Americans with chronic illness and lowering drug pricing. Under CMS’ Innovation Center authority, the agency may test payment and service delivery models for the purpose of evaluating whether they will reduce Medicare, Medicaid and Children’s Health Insurance Program expenditures while preserving or enhancing the quality of care furnished to the beneficiaries of such programs. Each of the recently announced models presents opportunities for eligible participants to engage with CMS to gain clarification or finalize details and will be of broad interest to those involved in health care, life sciences and technology as the administration moves forward with implementation. The announcement of these models in the final days of 2025 sets the stage for further action by the Innovation Center to finalize and refine these models in 2026 and beyond. This client alert provides a high-level summary of the ACCESS, BALANCE, MAHA ELEVATE, GLOBE and GUARD Models.

ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model

Initial Application Deadline for Eligible Participants is April 1, 2026, Model Begins July 5, 2026

On December 4, 2025, CMS announced ACCESS, a 10-year voluntary model to test a new payment approach to expand access to technology-supported care for people with common chronic conditions, such as hypertension, obesity, prediabetes, diabetes, chronic kidney disease, cardiovascular disease, chronic musculoskeletal pain, depression or anxiety. Each of the clinical tracks under the model has specific conditions and corresponding outcome aligned payment measures. ACCESS is focused on patients in traditional fee-for-service (FFS) Medicare (not Medicare Advantage) and organizations that are Medicare Part B–enrolled providers or suppliers (excluding durable medical equipment and laboratory suppliers) are eligible to participate. Notably, the Innovation Center signals in the Request for Applications that digital health and digital therapeutics companies could meet the criteria for participating in the model. As part of an ACCESS collaboration, on December 5, 2025, the Food and Drug Administration (FDA) Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a new voluntary pilot that seeks to accelerate innovation and expand access to digital health devices for people living with chronic conditions. ACCESS will begin on July 5, 2026 and run through June 30, 2036. CMS plans to accept applications on a rolling basis beginning in January 2026.

BALANCE (Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth) Model

Deadline for State Medicaid Agencies and Part D plans to Submit a Notice of Intent to Participate is January 8, 2026; State Medicaid Agencies Can Join May 2026 and Part D plans Can Join January 2027

On December 23, 2025, CMS announced BALANCE, a voluntary model under which CMS will negotiate the drug pricing and coverage terms with manufacturers of glucagon‐like peptide‐1 (GLP-1) medications on behalf of state Medicaid agencies and Medicare Part D plan sponsors. Under the model, beneficiaries receiving GLP-1s for weight management will be provided access to a lifestyle support program; however, coverage will depend on participation by drug manufacturers, states or Part D sponsors and patients would be subject to qualifications set by the negotiations. The model will conclude in December 2031. While the coverage for weight loss under BALANCE will launch in Medicaid as early as May 2026 and in Medicare Part D in January 2027, CMS expects Medicare Part D beneficiaries to have access to GLP-1s by July 2026 through a separate short-term demonstration that will serve as a bridge to BALANCE. BALANCE seeks to increase access to select GLP-1 medications and healthy lifestyle interventions to improve the health of both Medicare and Medicaid beneficiaries and lower health spending. Notably, CMS is looking to move very quickly to advance this model—the deadline for State Medicaid agencies and Part D plans to submit a notice of intent to participate is January 8, 2026.

MAHA ELEVATE (Make America Healthy Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence) Model

Notice of Funding Opportunity for Eligible Participants Expected to Be Released Early 2026, Model Begins September 1, 2026

On December 11, CMS announced MAHA ELEVATE, a new, voluntary model to begin on September 1, 2026, which aims to address lifestyle choices and behaviors associated with the prevention of chronic disease and the first CMS model to focus on proactive, holistic, patient-centered functional or lifestyle medicine approaches to care. Key areas of focus under the model include nutrition, physical activity, sleep, stress management, harmful substance avoidance and social connections. Under this model, approximately $100 million will be provided to fund 3-year cooperative agreements for up to 30 proposals that promote health and prevention for beneficiaries enrolled in traditional FFS Medicare and the collection of corresponding quality and cost data. CMS is looking for proposals to include services not already covered by traditional Medicare, but with documented evidence of the intervention’s efficacy, to partner with organizations with experience measuring and documenting improvements in health. CMS plans to work with model awardees on data collection, quality measurement, recruitment and cost containment. Notably, all proposals must incorporate nutrition or physical activity as part of the design and three awards will be reserved for interventions that address dementia. Cooperative agreements will be awarded in two separate cohorts, the first in 2026 and a second cohort in 2027. Those interested in potentially participating in this model should look for further details in early 2026, as CMS intends to release a Notice of Funding Opportunity then for the first cohort.

GLOBE (Global Benchmark for Efficient Drug Pricing) Model

Comments on the Proposed Rule Due February 23, 2026, Model Begins October 1, 2026

On December 19, 2025, a notice of proposed rulemaking for the GLOBE Model displayed in the Federal Register, noting a scheduled publication date of December 23, 2025, with comments due February 23, 2026. This model will be of particular interest to Medicare Part B providers, pharmaceutical manufacturers and beneficiaries enrolled in traditional FFS Medicare, given the potential impacts to each under the proposed model.

As discussed in the proposed rule, GLOBE tests a mandatory model to reduce Medicare Part B FFS drug spending and beneficiary coinsurance amounts using international drug pricing information as a benchmark to an alternative Part B inflation rebate amount calculation for certain single-source drugs and sole-source biological products. The proposed GLOBE Model would encompass a 7-year test period that includes five performance years (beginning October 1, 2026 and ending September 30, 2031), during which the GLOBE Model beneficiary coinsurance and adjusted payments to providers and suppliers could apply and monitoring activities would occur and seven payment years (beginning October 1, 2026 and ending September 30, 2033) during which CMS would calculate, invoice, collect and reconcile the GLOBE Model rebates for a performance year. The proposed model would be implemented in randomly selected geographic areas representing 25% of the country’s Medicare Part B beneficiaries.

Under the proposed GLOBE Model, CMS would identify the GLOBE Model drugs within a subset of separately payable Medicare Part B covered drugs that meet the statutory definition of a Part B rebatable drug, which include outpatient drugs and biologicals provided as part of a physicians’ service and drugs that are not usually self-administered that: (1) have the following listed USP DC categories: Antigout Agents, Antineoplastics, Blood Products and Modifiers, Central Nervous System Agents, Immunological Agents, Metabolic Bone Disease Agents, Ophthalmic Agents; (2) are single-source drugs or sole- source biological products; (3) have a HCPCS Level II code with Medicare Part B FFS spending greater than $100 million over a 12-month period and (4) are not excluded from the GLOBE Model due to having a Maximum Fair Price in effect or meeting other specified exclusion criteria. Manufacturers of GLOBE Model drugs would be subject to new requirements under the proposed model, including new GLOBE Model rebate payment activities and model related evaluation and monitoring activities.

GUARD (Guarding U.S. Medicare Against Rising Drug Costs) Model

Comments on the Proposed Rule Due February 23, 2026, Model Begins January 1, 2027

On December 19, 2025, a notice of proposed rulemaking for the GUARD Model displayed in the Federal Register, noting a scheduled publication date of December 23, 2025, with comments due February 23, 2026. This model will be of particular interest to stand-alone prescription drug plans under Medicare Part D, pharmaceutical manufacturers and beneficiaries enrolled with prescription drug coverage under Part D given the potential impacts to each under the proposed model.

As discussed in the proposed rule, the GUARD Model would test an alternative approach to the Inflation Reduction Act’s (IRA’s) Part D Inflation Rebate Program that would change the calculation of the Part D drug inflation rebates for certain Part D drugs and biological products, including sole-source drugs and sole-source biologics that meet a minimum threshold of prescription drug spend and are in the following therapeutic categories: Analgesics; Anticonvulsants; Antidepressants; Antimigraine Agents; Antineoplastics; Antipsychotics; Antivirals; Bipolar Agents; Blood Glucose Regulators; Cardiovascular Agents; Central Nervous System Agents; Gastrointestinal Agents; Genetic or Enzyme or Protein Disorder: Replacement or Modifiers or Treatment; Immunological Agents; Metabolic Bone Disease Agents; Ophthalmic Agents and Respiratory Tract/Pulmonary Agents.

Under this model, CMS would calculate the Medicare Part D inflation rebate amount using a benchmark derived from international pricing information based on either manufacturer-reported international pricing information or available information to CMS for countries that meet certain gross domestic product per capita and minimum real economy size thresholds. Under the proposed rule, the GUARD Model’s period of performance would start on January 1, 2027 and end on December 31, 2033, and the payment period for the model would run January 1, 2027 through December 31, 2035. The model would be implemented in randomly selected geographic areas representing 25% of beneficiaries who have a Medicare Part D plan. Sole-source generics and any (sole or multi-source) biosimilar biological products are not included in the GUARD Model. Drugs that are selected for Medicare Drug Price Negotiation program will be excluded from the GUARD Model when the negotiated Maximum Fair Price is in effect. Manufacturers of GUARD Model drugs would be subject to new requirements under the proposed model, including new GUARD Model rebate payment activities and model related evaluation and monitoring activities.

Next Steps

Health policy continued to be an active area for policymakers throughout 2025 by both the administration and on Capitol Hill. CMS’ Innovation Center has leaned into testing new models to lower drug pricing and improve the health of Americans with chronic illness and may look to build on these efforts further with additional models, creating opportunities for model participants to engage with the agency. The ACCESS, BALANCE, MAHA ELEVATE, GLOBE AND GUARD Models announced by CMS at the end of 2025 underscore that these policy areas of focus will continue to be active and evolving in the New Year.