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

Participation in BALANCE is voluntary for manufacturers, state Medicaid agencies, and Part D plans. Who can take part:

• Eligible manufacturers are those that are eligible for the initial negotiations or expect to market an eligible product by January 1, 2027. An eligible product must have an active ingredient that has been approved by the FDA for weight management (or products with the same active ingredient that have been previously approved for weight management or, have an active ingredient that is expected to be approved by the FDA for weight management by no later than January 1, 2027); be, or act as, a gastric inhibitory polypeptide (GIP) receptor agonist, GLP‐1 receptor agonist, glucagon receptor agonist, or in any combination; and have clinical evidence that, at an FDA-approved dose, the product reduces body weight by at least 9.5% on average, according to the primary or secondary endpoint in a randomized clinical trial.
• States and territories that participate in the Medicaid Drug Rebate Program (MDRP).
• Part D sponsors in all states and territories will be eligible to participate in the model, through Prescription Drug Plans (PDPs) or through Medicare Advantage (MA) coordinated care plans (i.e., HMO, HMOPOS, and Local and Regional PPO plans) that offer prescription drug coverage (MA-PD plans), including Special Needs Plans (SNPs) and all employer/union group waiver plans (EGWPs) that offer Part D.

When will GLP-1s for weight loss be available under BALANCE?

The coverage for weight loss under the BALANCE Model will launch in Medicaid as early as May 2026.

Eligible Medicare Part D beneficiaries are expected to have access to GLP-1s by July 2026 through a separate short-term demonstration, the Medicare GLP-1 Bridge.

Coverage in the Medicaid program will depend on participation by drug manufacturers and states. Patients would be subject to qualifications set by the negotiations between CMS and participating manufacturers, including certain prior authorization requirements. Therefore, this model will not guarantee coverage for any individual.

What lifestyle interventions are available through this model?

All beneficiaries receiving GLP-1s for weight management under the BALANCE model in Medicaid will be provided with access to a lifestyle support program, provided by the manufacturer at no cost. The lifestyle intervention offers education on how to maintain weight loss and make positive health choices to help improve health and will be available to patients during and after medication treatment.

As new drugs receive FDA approval, will they be included in the model?

The CMS Innovation Center expects to renew negotiations given the dynamic nature of the drug landscape, including when new products enter the market and as prices change over time. Full details of eligibility for the model test were outlined in the Manufacturer RFA.

What drugs are included in the BALANCE Model?

All formulations of Mounjaro®, Ozempic®, Rybelsus®, and Wegovy®, the KwikPen formulation of Zepbound®, and Foundayo™. These are included for both currently covered indications (ex: type 2 diabetes) as well as weight management indications.

Will the Medicare GLP-1 Bridge continue into 2027?

Yes. The Medicare GLP-1 Bridge has been extended through December 31, 2027. More information on the Medicare GLP-1 Bridge can be found on the Medicare GLP-1 Bridge webpage; please direct any technical questions related to the Medicare GLP-1 Bridge at to glp1demo@cms.hhs.gov.

What is the impact of the BALANCE Model not launching in Medicare in 2027 on the Medicare GLP-1 Bridge?

The Medicare GLP-1 Bridge will be extended through December 31, 2027, providing eligible Medicare Part D beneficiaries with access to certain GLP-1 drugs and allowing CMS to collect additional data on GLP-1 utilization to share with Part D plan sponsors ahead of potential implementation of BALANCE in Part D.

• Press Release: BALANCE Model
• BALANCE Manufacturer RFA (PDF)
  • Optional Appendix: This excel file may be used to provide the requested information on eligible model drugs for both Medicare and Medicaid coverage.
• BALANCE State Medicaid RFA (PDF)
• BALANCE Part D Sponsor RFA (PDF)
• Appendix A: Part D Applications Template (XLSX)
• CY 2027 BALANCE Model PDE and Bid Submission Guidance (PDF)

Additional information on the CMS Medicare GLP-1 payment demonstration will be made available before its implementation. Contact the GLP-1 Payment Demonstration team at glp1demo@cms.hhs.gov.