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 10% 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 and in Medicare Part D in January 2027. However, Medicare Part D beneficiaries are expected to have access to GLP-1s by July 2026 through a separate short-term demonstration that will serve as a bridge to BALANCE.

Coverage will depend on participation by drug manufacturers, states or Part D sponsors. Patients would be subject to qualifications set by the negotiations, 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 will be provided 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.

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

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

How will BALANCE affect people with Medicare or Medicaid already prescribed a GLP-1?

People with Medicare or Medicaid who already qualify and receive a GLP-1 drug may be eligible to receive those products at a lower price in participating states and Medicare plans.

How does BALANCE complement the Medicare GLP-1 demonstration beginning in July 2026?

CMS plans to implement a new GLP-1 payment demonstration beginning July 2026 that will serve as a short-term bridge to the BALANCE Model that starts in 2027. This additional payment demonstration means that more Medicare beneficiaries can start accessing these important medications at prices negotiated by the Administration as soon as possible.

The GLP-1 payment demonstration will operate outside of the Medicare Part D benefit’s coverage and payment flow, which means that Part D Plan Sponsors will not carry risk for eligible GLP-1 products furnished under the demonstration. Beneficiaries enrolled in Medicare Part D who meet the negotiated access criteria will have access to these drugs. Eligible Medicare beneficiaries will pay $50 per month of GLP-1 medications.

CMS will provide additional information on the design and implementation of the GLP-1 payment demonstration in early 2026.

Do Part D Plan Sponsors need to take any actions for the Medicare payment demonstration that is starting in July 2026?

The Medicare payment demonstration starting in July 2026 will operate outside of the Part D benefit’s coverage and payment flow. CMS will administer the entirety of the payment demonstration. CMS will communicate further details on the implementation of the payment demonstration in early 2026.

• Press Release: BALANCE Model
• BALANCE Manufacturer RFA
  • Optional Appendix: This excel file may be used to provide the requested information on eligible model drugs for both Medicare and Medicaid coverage.
• State Medicaid Agency Notice of Intent
• Part D plan Notice of Intent
• 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.