General Model FAQs
What is the status of the Cell and Gene Therapy (CGT) Access Model?
Following a successful negotiation period, the two drug manufacturers of gene therapies for treating sickle cell disease — bluebird bio, Inc. and Vertex Pharmaceuticals, Incorporated — have each entered into separate agreements with CMS to participate in the Cell and Gene Therapy Access Model. Under the model, these manufacturers offer outcomes-based arrangements (OBAs) to state Medicaid agencies. Upon application and acceptance into the model, 33 states, along with the District of Columbia and Puerto Rico, representing 84% of Medicaid beneficiaries with SCD, are now beginning participation in the model on a rolling basis between March 1, 2025 and January 1, 2026. In addition, seven of the participating states and the District of Columbia received Cooperative Agreement awards beginning on August 1, 2025. CMS is continuing to provide technical assistance to all participating states to help onboard them to the model and implement the OBAs.
What entities were eligible to apply for participation in the CGT Access Model?
There are two types of participants in the model: states and pharmaceutical manufacturers. All states and U.S. territories that participate in the Medicaid Drug Rebate Program (MDRP) were eligible to apply to participate in the model. Pharmaceutical manufacturers that participate in the MDRP and market U.S. Food & Drug Administration (FDA)-approved or -licensed gene therapies for the treatment of severe sickle cell disease were also eligible to participate in the model. Participation in the CGT Access Model is voluntary for both manufacturers and states.
What is an outcomes-based agreement and how does it work in the model?
An outcomes-based agreement (OBA) ties payment to the manufacturer to patients’ health outcomes over a certain time period. Under the model, if the gene therapy is less successful at improving health outcomes than expected, the drug manufacturer will reimburse the health care payer some portion of what was paid for the therapy. Agreements may also include other price concessions, such as guaranteed rebates.
CMS has negotiated with manufacturers on behalf of states for cell and gene therapies that are administered to beneficiaries for whom Medicaid is the primary payer. Instead of each state creating and implementing its own OBAs with manufacturers, the model will allow CMS to bring states together and negotiate on a multi-state basis. CMS will also be responsible for establishing financial and clinical outcome measures, reconciling data, and evaluating results. Participating states will still be responsible for their share of the cost of the cell and gene therapy, but at a pricing rebate tied to specific outcomes, as negotiated by CMS.
Why does the CGT Access Model begin with a focus on sickle cell disease?
Before December 8, 2023, there was only one cure: allogenic hematopoietic stem cell transplantation, which requires a close donor match (typically from a healthy sibling). There are other FDA-approved therapies used to treat the symptoms associated with sickle cell disease, but they do not hold the same transformative potential as gene therapies.
In December 2023, the FDA approved two gene therapies for the treatment of certain patients with sickle cell disease. CASGEVY™ from Vertex Pharmaceuticals, Incorporated was listed at $2.2 million per patient and LYFGENIA™ from bluebird bio, Inc was listed at $3.1 million per patient. These potentially life-changing therapies have shown great promise in improving patients’ health, preventing further organ damage, and boosting quality of life. Between 50% and 60% of people living with sickle cell disease have Medicaid coverage and the high price of these treatments may strain state Medicaid agencies’ budgets.
This model will help make it easier for states to provide access to such therapies to people with Medicaid who are eligible for such treatments.
Is CMS considering adding outcomes-based arrangements for other disease areas to the model?
CMS is continuing to explore ways to include additional conditions in the model as additional cell and gene therapies are approved by the FDA. Please reach out to the CGT Access Model Team at CGTModel@cms.hhs.gov using the subject line “Future Model Considerations” to provide input on future conditions the model might include as a focus area, or other directions the CGT Access Model might consider.
When did the model start and when will results be published?
The CGT Access Model went live with a “rolling start” in January 2025; states could choose to begin participation at a time of their choosing between January 2025 and January 2026. The first state began participating in the model on March 1, 2025. If additional disease conditions are added to the model in future years, states will be permitted to apply for model participation for that condition.
The model is expected to consist of eleven Performance Years (PYs). For all participating states, the model performance period is anticipated to conclude at the end of PY11 on December 31, 2035, unless the state’s participation in the model is terminated earlier. The performance period of the model includes an administration period; a measurement period; and a reconciliation period to allow for data to flow in, and for payments under the OBA to be made. A series of evaluation reports will be produced starting in 2027 and concluding after the model ends in 2035 to allow for final model reconciliations and data lags.
Does this model qualify as an Advanced or MIPS Alternative Payment Model (APM)?
No, health care providers are not participants in the model and thus it does not qualify as an Advanced or MIPS APM under the Quality Payment Program (QPP).
State Application and Participation FAQs
More information on the application process can be found in the State Request for Applications (RFA) (PDF) published on June 28, 2024, and updated on February 18, 2025.
When did states apply to participate in the model? Which states were eligible to apply to participate in the model and how many states applied?
CMS released a State Request for Applications (RFA) in June 2024. Key Terms were shared with states in December 2024, and applicants had until March 2025 to apply. All states, the District of Columbia, and U.S. territories that participate in the Medicaid Drug Rebate Program (MDRP) were eligible to apply to participate in the model. 33 states, along with the District of Columbia and Puerto Rico, applied, were accepted, and signed State Agreements to participate in the model. Participation in the Cell and Gene Therapy (CGT) Access Model is voluntary for both manufacturers and states.
Do participating states have to enter into supplemental rebate agreements (SRAs) with both participating manufacturers?
No. Participating states select at least one Model Drug from a participating manufacturer as their “State-Selected Model Drug(s)” and adopt the Key Terms associated with that therapy. States may change their State-Selected Model Drug(s) during the model performance period, so long as they continue to meet the participation requirements with respect to maintaining at least one Model Drug and associated Key Terms at all times.
What are the requirements of states that participate in the model?
Participating states must implement policy, operational, and system requirements to support the model. These include having or obtaining the necessary authority to implement the model, including CMS approval of a state plan amendment (SPA) to enter into a value-based purchasing (VBP) SRA; establishing a standardized State-Selected Model Drug access policy, consistent with the CMS-Manufacturer negotiated Key Terms; carving State-Selected Model Drugs out of an inpatient payment bundle, if necessary; and aligning with their managed care plans by 2026, to name a few.
For more details, see Section 3 of the State RFA. All requirements are detailed in the State Agreement.
Can a state use its existing value-based purchasing (VBP) supplemental rebate agreement (SRA) template to establish SRAs with the participating manufacturers? Does it have the option of using a different template?
Yes; participating states have two options: (a) use an existing, CMS-approved template with modifications to the appendices to align with model-negotiated Key Terms, or (b) use the CGT Access Model SRA template.
- If a state’s existing VBP SRA template has language that allows for modifications or amendments, that state may leverage that language to make changes in the appendices to the template, such as adding additional appendices (like the CMS-negotiated Key Terms), or clarifying that the provisions of the Key Terms govern in the event of any conflict or inconsistency between the Key Terms and the body of the template. This path would not require going back to the Center for Medicaid and CHIP Services (CMCS) for a State Plan Amendment (SPA) submission or any additional approvals.
- CMS released to states a CGT Access Model SRA Template, which is intended to fit neatly with the CMS-negotiated Key Terms. Any state that has an existing approved VBP SPA may use the CGT Access Model SRA Template without additional approvals from the Center for Medicaid and CHIP Services. The template we have created is designed so that states may attach the CGT Access Model Key Terms in their entirety (as uploaded into the Medicaid Drug Pricing (MDP) system) as Appendix A to the template. States may use Appendix B to include any additional provisions that are needed by the state for legal or implementation purposes, or any permissible state-specific variation from the CMS-negotiated Key Terms. Please note that this template may only be used as part of the CGT Access Model for states with an existing VBP SPA.
States are encouraged to select the option that works best for them and the relevant manufacturer. States can reach out to the model team at cgtmodel@cms.hhs.gov for questions.
What are the model requirements related to managed care alignment?
States must join the model with both their fee-for-service (FFS) and managed care populations.
States must coordinate with their managed care plans to ensure alignment with all model requirements, but they are free to choose how to manage their relationships with managed care plans. For example, adjusting kick payments (i.e., one-time, fixed, supplemental payments made to plans) or capitation rates, or carving the gene therapies out of their managed care contracts.
For more detail, see Section 3.1.6 of the State RFA. All requirements will be detailed in the State Agreement.
Can states start with their fee-for-service population and managed care population on different dates?
Yes. States have the flexibility to start with either population, so long as both populations are in the model by January 1, 2026. For example, states may choose to start with their fee-for-service beneficiaries first and bring their managed care beneficiaries into the model as late as January 1, 2026, if they need more time to coordinate with managed care entities. States may also start with both populations at the same time.
How is CMS helping states implement model requirements?
CMS is providing technical assistance to all state participants to support them in implementing model requirements. States can also reach out to their pharmacy contact at the Center for Medicaid and CHIP Services (CMCS) for technical assistance. Additionally, states were able to apply for funding for activities related to model implementation (among other things) through the optional Notice of Funding Opportunity (NOFO).
Does the model change the share of state Medicaid costs funded by the state or federal government?
The model will not alter the division of financial responsibility between states and the federal government. States will continue to be responsible for their share of the cost of the model gene therapy, but subject to supplemental rebates negotiated by CMS. States will be obligated to pay for the gene therapy and will receive Medicaid matching funds from the federal government at the current Federal Medical Assistance Percentage (FMAP), consistent with current Medicaid policy.
Can CMS provide more guidance about the model requirement to make a separate payment to health care providers for the gene therapy?
States participating in the CGT Access Model (and their managed care plans) must make payments to providers for a State-Selected Model Drug in the form of direct reimbursement. If a state typically pays for inpatient drugs as part of a bundled payment (e.g., Diagnosis-Related Groups (DRGs); Ambulatory Payment Classifications (APCs)), it must carve the State-Selected Model Drug out of the inpatient payment bundle. This allows the Model Drug to be considered a "covered outpatient drug" and included in the MDRP. For more information, states can reach out to their pharmacy contact at the Center for Medicaid and CHIP Services.
If a state chooses to participate in the model, can it attempt to negotiate additional discounts or terms other than those negotiated by CMS?
No. If a state opts to participate in the model, it must enter into an agreement with the manufacturer that reflects the terms negotiated by CMS. Limited state-to-state variation may be permitted by CMS, as may be necessary in certain situations for a state to comport with their legislative and regulatory requirements.
For participating states, does separate billing for an included gene therapy mean that a hospital could purchase a Model Drug under the 340B program?
Under the model, administration of gene therapy for sickle cell disease will be for individuals who are inpatient. The 340B program does not apply to drugs used for individuals who are inpatient. Please see the Health Resources and Services Administration (HRSA) website for additional information.
Are states required to pay for fertility preservation services under the model?
No. Under the CGT Access Model, participating manufacturers will be required to financially support a defined scope of fertility preservation services that includes collection, cryopreservation, and storage of reproductive material (i.e., eggs, sperm, ovarian tissue, and testicular tissue) for at least five years and up to 15 years. These services would be provided at no cost to beneficiaries receiving treatment within the model and at no cost to other payers. State participants must not claim any costs for services paid for by a manufacturer as state expenses for purposes of federal financial participation (FFP). States may (but are not required to) provide additional fertility preservation services (not covered by manufacturer participants) through the Medicaid family planning benefit.
How does the model facilitate access to out-of-state treatment?
States participating in the model must ensure beneficiaries have access to at least one qualified SCD gene therapy provider, either in-state or out-of-state. If a state does not have an in-state SCD gene therapy provider, it must pay for out-of-state services as per 42 CFR § 431.52.
Several model requirements are designed to help states plan more proactively for their beneficiaries to be able to receive out-of-state treatment, thus reducing delays in care for individual beneficiaries (see section 3.3.1 of the State RFA). For example, states must maintain a contract with a treatment center qualified to administer each State-Selected Model Drug and must ensure that at least one qualified SCD gene therapy provider in each contracted treatment center is enrolled in the state Medicaid program.
CMS is continuing to provide technical assistance to participating states. For more guidance, states are encouraged to review CMCS guidance on coordinating care from out-of-state providers (while the guidance is in the context of care for children with medically complex conditions, it includes information that applies more broadly). For assistance with out-of-state provider enrollment questions, states may contact the Center for Program Integrity at MedicaidProviderEnrollment@cms.hhs.gov.
What data will states be required to track and submit to CMS?
Participating states will be required to submit Medicaid claims data to CMS, primarily through the Transformed Medicaid Statistical Information System (T-MSIS). States will be expected to meet (or have a plan to meet) the data quality standards outlined in the T-MSIS Outcomes Based Assessment methodology. States will also have to submit quarterly reports related to model implementation.
For more detail on data and reporting requirements, see Section 3.4 of the State RFA. All requirements will be detailed in the SA.
What is the CMS-designated patient registry for the model, and how can treatment centers join?
Participating states (and their managed care plans) must condition payment for the administration of State-Selected Model Drugs to Model Beneficiaries on provider adherence to the following requirement: the provider must be a member of the CMS-designated patient registry for the model and participate in the study related to this model. CMS will communicate to model-participating states if any treatment center authorized by participating Manufacturers to administer the Model Drug(s) fails to meet this requirement. The CMS-designated registry for the model is the Center for International Blood and Marrow Transplant Research (CIBMTR). CIBMTR member centers will receive information about the CGT Access Model study directly from CIBMTR. For more information about the CIBMTR study, please contact Lexi Finck, CIBMTR Research Program Coordinator, lfinck@mcw.edu.
What types of data will be collected in the CIBMTR study?
The study will include collection of a standard set of clinical data and patient-reported outcomes (PROs) data from people with Medicaid receiving gene therapy for SCD, which CIBMTR will share with CMS. For patients who volunteer and consent to participate in the study, CIBMTR will administer surveys containing PROs on a number of relevant topics, including: anxiety; depression; pain; fatigue; sleep disturbance; economic and financial burden; sociodemographic information; and cognitive, social, and physical function. PRO surveys will be administered to patients prior to infusion, 30 days post-infusion, 100 days post-infusion, 180 days post-infusion, 1-year post-infusion, and annually thereafter, up to five years post-infusion. In addition, the study will collect a broad set of clinical data that researchers have identified as important to gene therapy treatment for SCD, such as lab values related to the percentage of hemoglobin that is not abnormal.The outcomes data for both model beneficiaries as well as a comparison group (people with Medicaid who receive gene therapy for SCD living in states that do not participate in the CGT Access Model) will enhance the understanding of the patient care journey, the clinical outcomes of the SCD population, and the impacts of the model. CMS plans to share aggregate data related to these studies in published reports as the data becomes available.
What CMS learning support is provided to states implementing the model?
CMS is committed to supporting model participants through learning and collaboration opportunities. The learning framework will include:
- Virtual peer networking: Opportunities for participants to connect and share experiences, challenges, and promising practices.
- Knowledge sharing: Dissemination of effective implementation and improvement strategies informed by real-world participant successes.
- Targeted support: While many events and resources will be designed to support participants across many models, select learning resources will be tailored and promoted specifically to CGT participants.
CMS will continue to assess participant feedback and model implementation experiences to inform the development of learning support offerings. More details about specific learning opportunities will be shared as they become available.
State Cooperative Agreement Funding FAQs
More information can be found in the Notice of Funding Opportunity (NOFO) published on August 15, 2024, and updated on February 18, 2025
When was the funding application available, and what entities were eligible to apply?
CMS released a Notice of Funding Opportunity (NOFO) in August 2024. Applicants had until March 14, 2025 to apply. CMS issued awards in August 2025.
Eligible applicants were states, the District of Columbia, and any U.S. Territory participating in the Medicaid Drug Rebate Program (MDRP). To be considered for Cooperative Agreement funding, the applicant must have submitted an application to the State RFA and signed a State Agreement with CMS.
Were all states that were interested in participating in the CGT Access Model required to respond to the NOFO?
No. States that are interested in participating in the CGT Access Model are only required to respond to the State RFA. Only states that are interested in optional Cooperative Agreement funding are required to respond to the NOFO.
Cooperative Agreement funding, available to states that successfully apply to the NOFO, is intended to support state model implementation activities and to support states that take steps to improve access to gene therapy and multi-disciplinary, comprehensive care in conjunction with the model test.
What is the funding amount and duration of award for the CGT Access Model?
Selected applicants will receive up to $9.55 million in Cooperative Agreement funding over a period of 10 years and 5 months. The Model Performance Period and the Cooperative Agreement Period of Performance are anticipated to conclude on December 31, 2035.
How were states selected for funding?
States interested in receiving optional model funding had to apply during the NOFO period. This was a competitive application process, including a merit review of all applications. A merit review committee evaluated each application using the criteria described in Section E1 of the NOFO.
What is the difference between Implementation and Milestone Funding?
Implementation Funding and Milestone Funding are two distinct types of financial support available under the Cooperative Agreement in the CGT Access Model. Implementation Funding is designed to support required and optional model activities that involve staff/contractor time and infrastructure costs. Milestone Funding is designed to support states that successfully complete research projects related to increasing access to SCD gene therapy and promoting multi-disciplinary, comprehensive care for beneficiaries with SCD who are considering or receiving SCD gene therapy.
How can Implementation Funding be used?
Implementation Funding, as outlined in Section A6.8.1 of the NOFO, is designed to support required and optional model activities that involve staff/contractor time and infrastructure costs. States can use these funds to engage in a variety of activities such as data collection, coordination with managed care plans and out-of-state providers, and partnerships with CBOs.
Specifically, states may collaborate with CBOs to provide enhanced services focusing on increasing awareness and education about gene therapy among patients and healthcare providers, improving access to supportive services necessary for receiving gene therapy (like transportation and lodging), providing services related to addressing health-related social needs, and providing community health worker/patient navigator and peer supports. As detailed in Section F5.1.1, states are required to report at least quarterly on how Implementation Funding is utilized, ensuring accountability and alignment with the overall objectives of the model.
How can Milestone Funding be used?
Milestone Funding, as outlined in Section A6.8.2 of the NOFO, is designed to support research projects related to increasing access to SCD gene therapy and promoting multi-disciplinary, comprehensive care for beneficiaries with SCD who are considering or receiving SCD gene therapy. Milestone Funding is restricted (unavailable) unless the state demonstrates satisfactory completion of the research project in a submitted performance report. Unrestricted Milestone Funding can only be used for cost-based reimbursement of completed Milestone Funding projects. This means that the funds are specifically allocated to cover the expenses related to the research activities once the project is satisfactorily completed and reported.
Are there restrictions on the use of funds?
CMS prohibits the use of Cooperative Agreement funding to reimburse pre-award costs or to supplant existing state, local, tribal, or private funding of state costs.
For a full list of all the applicable limitations on the use of funds, please review Sections D6 and F2 of the NOFO. These sections provide comprehensive guidelines to ensure the funds are used appropriately and in alignment with the overall objectives of the CGT Access Model.
What are the reporting requirements for the award?
Recipients will be required to comply with both federal reporting requirements and model-specific reporting requirements. For example, states will be required to submit quarterly progress reports on activities for which Implementation Funding is used and performance reports to demonstrate completion of Milestone Funding research projects. For a detailed list of all reporting requirements, including specific conditions and procedures, refer to Section F5 of the NOFO.
How can states partner with organizations under this NOFO?
States can use Implementation Funding to partner with CBOs with a focus on providing services to individuals with SCD who are considering or undergoing gene therapy for SCD. Implementation Funding can be used to pay CBOs for any of the following purposes: increasing awareness and education of gene therapy among patients and health care providers, increasing awareness and access to supportive ancillary services necessary for beneficiaries to receive gene therapy, providing services related to addressing access barriers, and providing community health worker/patient navigator and peer supports.
States can also partner with organizations to conduct Milestone Funding research projects. Partner organizations may include CBOs, treatment centers qualified to administer gene therapy for SCD, or academic institutions.
What are the terms and conditions for partnerships with CBOs?
Partnerships with CBOs have specific terms and conditions under the NOFO. Recipients seeking funding for these partnerships are required to include specific items in their reporting submissions. Furthermore, recipients must submit a full performance report of all funded CBOs on an annual basis. In each quarterly progress report, recipients must submit an updated Partnership List that includes details of all funded CBOs such as their name, mailing address, primary contact details, and amount of award. This ensures transparency, accountability, and effective monitoring of the funded CBOs.
States can also stay informed about upcoming webinars and events hosted by CMS by joining the CGT Access Model listserv.
For any questions, states can reach the CGT Access Model team at CGTModel@cms.hhs.gov.