CMS launches voluntary BALANCE Model to expand access to GLP-1 medicines in Medicare and Medicaid

The US Centers for Medicare & Medicaid Services (CMS) has launched a new voluntary payment and coverage model aimed at expanding access to GLP-1 medicines across Medicare and Medicaid. The BALANCE Model will test whether CMS-led price negotiations, combined with evidence-based lifestyle supports, can improve cardiometabolic outcomes while managing program spending.

The Centers for Medicare & Medicaid Services (CMS), through its Innovation Center (CMMI), has announced a new voluntary drug pricing and coverage initiative designed to expand access to GLP-1 medications while testing whether negotiated pricing and lifestyle support can improve health outcomes and manage costs across Medicare and Medicaid.

Positioned as a further step in CMMI’s recent drug pricing activity, the Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) Model will test whether CMS-led negotiations with drug manufacturers, paired with access to evidence-based lifestyle interventions, can preserve or enhance quality of care while reducing or maintaining program expenditures. The model is scheduled to launch for state Medicaid agencies as early as May 2026, and for Medicare Part D plans in January 2027, with testing running through December 2031.

Under BALANCE, CMS will negotiate directly with manufacturers of eligible GLP-1 therapies on behalf of participating state Medicaid agencies and Medicare Part D plan sponsors. Negotiated terms may include guaranteed net pricing, standardized coverage criteria, potential out-of-pocket limits for beneficiaries, and manufacturer-provided lifestyle support programs. Participation will be voluntary for manufacturers, states, and plans.

Eligible beneficiaries will be those enrolled in participating plans or states who meet negotiated access requirements, including defined BMI thresholds and, where applicable, evidence of metabolic dysfunction such as heart failure, uncontrolled hypertension, or pre-diabetes, in line with FDA-approved labeling.

Qualifiable products must have an active ingredient approved by the US FDA for weight management or be expected to receive such approval by January 1, 2027. Products must act as, or include, a GLP-1 receptor agonist, GIP receptor agonist, glucagon receptor agonist, or a combination thereof, and demonstrate an average weight reduction of at least 9.5% at an FDA-approved dose in a randomized clinical trial.

Beyond drug pricing, the model places emphasis on expanding access to evidence-based lifestyle support, including nutrition and physical activity programs. These are consistent with FDA labeling, which recommends that GLP-1 therapies be used alongside appropriate lifestyle modification. CMS says the supports are intended to improve uptake, adherence, and long-term cardiometabolic outcomes for beneficiaries.

CMS will also take a central role in data collection, monitoring, and evaluation, with the CMMI supporting participants in implementation and oversight. The model will assess impacts on health outcomes, medication adherence, beneficiary experience, and program spending. To facilitate participation and generate potential federal savings, CMS is exploring rebate options and statutory or program instruction waivers, including exemptions related to Maximum Fair Price effectuation for certain claims under the model.

Announcing the initiative, CMS Administrator Mehmet Oz said the model builds on broader drug pricing reforms aimed at improving access to medicines that have historically been out of reach for many patients. “With the BALANCE Model, we’re pairing breakthrough science with healthy living to cut costs while empowering Americans to take control of their health,” he said.

Manufacturers interested in participating must respond to the BALANCE Request for Applications by January 8, 2026, with notices of intent from state Medicaid agencies and Medicare Part D plans due on the same date. CMS has indicated that additional operational guidance will be released in early 2026, alongside details of a separate Medicare GLP-1 payment demonstration intended to serve as a short-term bridge ahead of full BALANCE implementation.