CMS Announces Plans to Expand Voluntary Cell and Gene Therapy Access Model Beyond Sickle Cell Disease

On October 27, 2026, the Centers for Medicare & Medicaid Services (CMS) announced plans to expand its voluntary Cell and Gene Therapy (CGT) Access Model (Model) beyond sickle cell disease (SCD) to include manufacturers of other CGTs. CMS states that the expansion could include manufacturers of both existing and future Food and Drug Administration (FDA)–approved CGTs. The announcement follows an initial evaluation report regarding the model, which concluded that CMS-led negotiations of outcomes-based rebate agreements between CGT manufacturers and state Medicaid agencies can provide an efficient alternative to individual state-by-state negotiations for high-cost therapies.

CMS’s announcement leaves several key questions unanswered, including which categories of CGTs will be prioritized under the expanded Model. The agency’s initial evaluation report and other publications provide certain insights into its potential direction and considerations for CGT manufacturers.

1. Overview of Existing SCD Model. As previously discussed here, CMS announced in February 2024 that the Model would initially focus on SCD. CMS stated that it selected SCD based on its relatively high prevalence among Medicaid beneficiaries, the limitations of existing treatment options, and the anticipated introduction of new therapies.
   
   CMS identified two primary objectives for the Model: (i) reducing CGT costs for state Medicaid agencies and (ii) improving patient access while preserving patient choice. CMS subsequently explained that given the significant difference in the initial prices of the two participating SCD therapies, it sought to minimize price disparities that could otherwise incentivize states to favor the less expensive product.
   Following approximately nine months of negotiations, CMS executed participation agreements with the two SCD manufacturers establishing key terms for reimbursement by participating state Medicaid agencies, including rebate structures, coverage criteria, access policies, and manufacturer payment for fertility preservation services. Ultimately, 34 Medicaid programs, representing approximately 84% of Medicaid beneficiaries with SCD nationwide, elected to participate in the Model.¹

Key Findings From CMS’s Initial Evaluation Report. In August 2026, CMS released an initial evaluation report assessing the effectiveness and efficiency of its process for negotiating outcomes-based agreements with CGT manufacturers and securing state Medicaid agency participation. Based on interviews with CMS personnel, both participating SCD manufacturers, and representatives of state Medicaid agencies, the report concluded that CMS-led agreement development can provide an effective and efficient alternative to individual state-by-state negotiations.

The report identified several advantages of the Model, including:

• Reduced negotiation burden. Both manufacturers and state Medicaid agencies generally viewed the centralized negotiation process as more efficient than negotiating separate agreements with individual states.
• Greater reimbursement certainty. Manufacturers viewed the Model as providing qualified treatment centers with greater assurance of timely and adequate reimbursement for CGTs.
• Support for fertility preservation services. Both manufacturers and state Medicaid agencies identified the ability for manufacturers to fund fertility preservation services under the Model as an appealing feature.

However, the report also identified challenges that may inform CMS’s approach to future negotiations, including the following:

• Administrative complexity. Both manufacturers and state Medicaid agencies characterized the Model agreements as more detailed and administratively intensive than typical value-based agreements.
• Protracted negotiations. CMS and manufacturers acknowledged that reaching agreement required extensive discussions and compromise, with manufacturers reporting that negotiations were more protracted than anticipated.
• Uncertainty regarding state participation. The report identified an inherent structural tension between manufacturers’ desire for greater certainty regarding the number of patients who would receive treatment under the Model and states’ preference to review negotiated agreement terms before committing to participation.

Despite these challenges, the report concluded that CMS successfully established a centralized framework for developing outcomes-based agreements while identifying opportunities to improve the efficiency of future negotiations.

3. CMS Announces Plans to Expand the Model. On October 27, 2026, CMS announced plans to broaden the Model beyond SCD to include manufacturers of other CGTs, citing the positive findings of its initial evaluation report. CMS stated that it expects to issue a request for applications (RFA) in the coming months and indicated that the expanded framework would facilitate negotiations for both existing FDA-approved therapies and therapies following FDA approval or licensure.

Although CMS has not yet identified the specific therapies or disease states that will be eligible for the expanded Model, earlier agency publications offer insight into its potential priorities.

In particular, a March 2026 article published by CMS officials in the New England Journal of Medicine, titled “The Cell and Gene Therapy Access Model — A Vision for Future Development," outlined several considerations that could shape future expansion:

• Priority CGT categories. CMS indicated that it would initially prioritize CGTs that
• Benefit substantial numbers of Medicaid beneficiaries
• Carry high costs or otherwise impose significant financial burdens on Medicaid programs
• Treat conditions for which multiple CGT market entrants are anticipated or where the Model could facilitate competition among available therapies
• Potential expansion to Medicare beneficiaries. Future iterations of the Model could extend beyond Medicaid to include Medicare beneficiaries.
• Alternative financing arrangements. CMS may consider additional financing mechanisms, including pay-over-time arrangements and subscription-based payment models.

These considerations remain distinct from CMS's October 27 announcement, which did not establish eligibility criteria or discuss whether additional beneficiary populations or financing arrangements would be included in the forthcoming expansion.

4. Potential Implications for CGT Manufacturers. CGT manufacturers, particularly those with approved or pipeline therapies expected to have significant Medicaid utilization, should monitor forthcoming CMS guidance regarding the scope of the expanded Model, manufacturer eligibility, and application timelines. Manufacturers may also wish to begin coordinating among internal stakeholders to evaluate the potential benefits and challenges of participation, including anticipated Medicaid utilization, potential pathways fertility preservation or similar support, rebate and outcomes-measurement requirements, and the implications for existing or planned state Medicaid agreements.
   
   The forthcoming RFA should provide greater clarity regarding whether the expanded Model presents an attractive opportunity for individual CGT manufacturers and to what extent CMS intends to incorporate lessons learned from the initial SCD implementation. 

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1See https://www.cms.gov/priorities/innovation/innovation-models/cgt; https://www.cms.gov/priorities/innovation/data-and-reports/2026/cgt-first-eval-report.