Cell and Gene Therapy (CGT) Access Model
ID: 354875Type: Posted
Overview

Buyer

Centers for Medicare & Medicaid Services (HHS-CMS)

Award Range

$0 - $10M

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/354875

Additional Information

https://www.grantsolutions.gov/gs/preaward/previewPublicAnnouncement.do?id=110782
Timeline
    Description

    The Centers for Medicare & Medicaid Services (CMS) has announced a funding opportunity for the Cell and Gene Therapy (CGT) Access Model, aimed at enhancing access to innovative gene therapies for Medicaid beneficiaries, particularly those suffering from sickle cell disease (SCD). Eligible applicants include States, the District of Columbia, and U.S. territories participating in the Medicaid Drug Rebate Program, with the initiative focusing on implementing outcomes-based agreements between CMS and gene therapy manufacturers to improve health outcomes and reduce healthcare costs. Each recipient may receive up to $9.55 million in cooperative agreement funding, with applications due by February 28, 2025, and the program spanning from July 1, 2025, to December 31, 2035. For further inquiries, interested parties can contact the Grants.gov Customer Support at support@grants.gov or call 1-800-518-4726.

    Point(s) of Contact
    support@grants.gov
    Files
    Title
    Posted
    CGT
    CGT.pdf
    The U.S. Department of Health and Human Services has announced a funding opportunity for the Cell and Gene Therapy (CGT) Access Model, aimed at enhancing Medicaid beneficiaries' access to innovative gene therapies for sickle cell disease (SCD). This initiative invites states, including the District of Columbia and U.S. territories participating in the Medicaid Drug Rebate Program, to apply for cooperative agreement funding. Each recipient may receive up to $9.55 million over the program span from July 1, 2025, to December 31, 2035. The model will implement outcomes-based agreements (OBAs) negotiated between the Centers for Medicare & Medicaid Services (CMS) and gene therapy manufacturers to ensure improved access and health outcomes for Medicaid recipients. State participation involves detailed requirements, including signing state agreements and submitting applications by February 28, 2025. The program is designed to address care delivery gaps, promote equitable access to treatment, and alleviate the complexities of negotiating contractual arrangements for gene therapies. Through these efforts, the CGT Access Model aims to reduce healthcare costs and improve patient outcomes for those afflicted with SCD in the United States.
    Similar Opportunities
    Health Home for Children with Medically Complex Conditions
    Active
    Centers for Medicare & Medicaid Services
    The Centers for Medicare & Medicaid Services (CMS) has announced a funding opportunity titled "Health Home for Children with Medically Complex Conditions," aimed at enhancing care coordination for Medicaid-eligible children under 21 with complex health needs. This initiative seeks to award planning grants to state governments for the development of a Section 1945A State Plan Amendment (SPA), which will facilitate comprehensive health home services, including care management and coordination across various healthcare providers. With a total funding amount of $5 million available, individual grants can reach up to $100,000, and the program is designed to improve health outcomes through structured care coordination that addresses medical, social, and support needs. Interested applicants must submit their proposals via Grants.gov by October 1, 2024, and can reach out to the Grants.gov Customer Support at support@grants.gov for assistance.
    Section 206 of the Consolidated Appropriations Act, 2024: State Planning Grants to Promote Continuity of Care for Medicaid and CHIP Beneficiaries Following Incarceration
    Active
    Centers for Medicare & Medicaid Services
    The Centers for Medicare & Medicaid Services (CMS) is offering planning grants under Section 206 of the Consolidated Appropriations Act, 2024, aimed at promoting continuity of care for Medicaid and CHIP beneficiaries following incarceration. Eligible applicants, including state governments and territorial agencies, are invited to develop operational capabilities to ensure that individuals who are inmates of public institutions and eligible for medical assistance receive necessary services during their transition back into the community. This initiative is critical for maintaining healthcare access for vulnerable populations and aligns with statutory requirements effective January 1, 2025, regarding service provision and eligibility retention for incarcerated individuals. The total estimated funding for this program is $106.5 million, with individual awards ranging from $0 to $5 million, and applications are due by February 14, 2025. Interested parties can reach out to PlanningGrantsPCC@cms.hhs.gov for further information.
    Health Home for Individuals with Chronic Conditions
    Active
    Centers for Medicare & Medicaid Services
    The Centers for Medicare & Medicaid Services (CMS) has announced a funding opportunity titled "Health Home for Individuals with Chronic Conditions," aimed at supporting state governments in planning health home initiatives for Medicaid-eligible individuals with chronic conditions. This grant program, which falls under the category of discretionary funding, seeks to enhance care coordination and improve integrated care for at-risk populations through strategic planning and implementation efforts. States can apply for individual awards up to $500,000, with a total funding pool of $15 million available, and applications are due electronically by October 1, 2024, at 11:59 PM Eastern Standard Time. For further inquiries, applicants can contact the Grants.gov Customer Support at support@grants.gov or call 1-800-518-4726.
    Transforming Maternal Health (TMaH) Model
    Active
    Centers for Medicare & Medicaid Services
    The Centers for Medicare & Medicaid Services (CMS) is inviting applications for the Transforming Maternal Health (TMaH) Model, a cooperative agreement aimed at enhancing maternal health care outcomes for individuals enrolled in Medicaid and the Children's Health Insurance Program (CHIP). This initiative seeks to engage state Medicaid agencies in implementing evidence-informed interventions over a ten-year period to reduce adverse pregnancy outcomes, such as low-risk cesarean sections and severe maternal morbidity, while improving program efficiencies and reducing costs. The TMaH Model is structured around three primary pillars: Access, Quality Improvement, and Whole-Person Care Delivery, with a total funding opportunity of up to $255 million available for up to 15 selected recipients. Applications are due by September 20, 2024, with the performance period commencing in January 2025; for further inquiries, interested parties can contact tmahmodel@cms.hhs.gov.
    Notice of Intent to Publish a Funding Opportunity Announcement for Somatic Cell Genome Editing Translational Coordination and Dissemination Center (U24, Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is forecasting a funding opportunity for the establishment of a Somatic Cell Genome Editing Translational Coordination and Dissemination Center (TCDC) as part of its Somatic Cell Genome Editing (SCGE) program. The objective of this initiative is to accelerate the development of genome editing therapeutic agents by facilitating Investigational New Drug (IND) application enabling studies, establishing regulatory approval pathways, and disseminating successful strategies for initiating first-in-human clinical trials. This funding opportunity is crucial for advancing innovative therapeutic approaches in health, with an estimated total program funding of $2 million and the expectation of one award. Interested applicants can reach out to Dr. Marrah Lachowicz-Scroggins at SCGEprogram@od.nih.gov or by phone at 301-827-8229 for further details, with the anticipated application due dates in Summer 2022 and an estimated award date of April 1, 2023.
    Improving well-being for individuals living with a blood disorder through evidence-based programs.
    Active
    Centers for Disease Control - NCBDDD
    The Centers for Disease Control - NCBDDD is offering a federal grant opportunity aimed at improving the well-being of individuals living with blood disorders through evidence-based programs. The initiative seeks to enhance the emotional, social, and physical health of affected individuals by promoting mental health literacy and adapting programs that build psychosocial skills, ultimately aiming to reduce morbidity and improve quality of life. With an estimated total program funding of $5,925,000, the agency plans to award four cooperative agreements, with individual awards ranging from $135,000 to $450,000. Interested applicants can reach out to Dr. Fiona Bethea at gvu0@cdc.gov or by phone at 404-639-4033, with applications due by May 15, 2025, and awards expected to be announced by September 1, 2025.
    Ultra-Rare Gene-based Therapy (URGenT) Network Resource Access (X01, Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through its National Institute of Neurological Disorders and Stroke (NINDS), has announced a funding opportunity titled "Ultra-Rare Gene-based Therapy (URGenT) Network Resource Access" (X01), aimed at facilitating research in gene-based therapies for ultra-rare neurological disorders affecting fewer than 6,000 individuals in the U.S. This initiative provides investigators with access to contract research organizations (CROs) and subject matter experts to assist in planning, manufacturing, and nonclinical therapeutic development, specifically for the preparation of Investigational New Drug (IND) applications without involving clinical trials. The program emphasizes collaboration and strategic planning to address the unmet medical needs of patients with ultra-rare diseases, encouraging multidisciplinary project teams to outline development plans and regulatory considerations. Interested applicants must submit their proposals by January 24, 2025, and can direct inquiries to the NIH OER Webmaster at OERWebmaster03@od.nih.gov. Additional information can be found at http://grants.nih.gov/grants/guide/pa-files/PAR-22-028.html.
    Translational Efforts to Advance Gene-based Therapies for Ultra-Rare Neurological and Neuromuscular Disorders (U01 - Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Translational Efforts to Advance Gene-based Therapies for Ultra-Rare Neurological and Neuromuscular Disorders" (U01), aimed at supporting Investigational New Drug (IND)-enabling studies and clinical trial planning for innovative gene-based therapeutics targeting ultra-rare diseases affecting fewer than 6,000 individuals. The program seeks to advance promising therapeutic candidates through robust proof-of-concept data and facilitate the submission of IND applications to the FDA, thereby addressing significant unmet medical needs within the ultra-rare disease community. Eligible applicants include higher education institutions, nonprofits, and governmental agencies, with a project period not exceeding two years and application deadlines ranging from October 2023 to February 2025. For further inquiries, interested parties can contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov, and additional details can be found at the provided NIH link.
    Innovation in Behavioral Health (IBH) Model
    Active
    Centers for Medicare & Medicaid Services
    The Centers for Medicare & Medicaid Services (CMS) is offering a funding opportunity for the Innovation in Behavioral Health (IBH) Model, aimed at integrating behavioral health care with physical health services through a cooperative agreement. This initiative seeks to test a value-based payment model for adult beneficiaries experiencing moderate to severe mental health conditions and substance use disorders, with the goal of improving care quality, access, and equity while reducing unnecessary healthcare expenditures. Up to eight state Medicaid agencies will be selected to participate, each receiving up to $7.5 million over an eight-year period starting January 1, 2025, with applications due by September 9, 2024. For further inquiries, interested applicants can contact the grantor at IBHModel@cms.hhs.gov.
    Hereditary Hemorrhagic Telangiectasia (HHT) Center
    Active
    Health Resources and Services Administration
    The Health Resources and Services Administration (HRSA) is forecasting a grant opportunity titled "Hereditary Hemorrhagic Telangiectasia (HHT) Center," aimed at reducing morbidity and mortality associated with HHT. The program's objectives include expanding access to care for HHT patients and developing a de-identified patient data registry to enhance understanding of this rare disease and its treatment outcomes. This cooperative agreement is crucial for improving health outcomes for affected individuals and is open to various domestic public or private entities, including faith-based organizations. The estimated total program funding is $2,000,000, with one award expected, and interested applicants should note that the synopsis is anticipated to be posted on January 10, 2025, with a closing date of April 11, 2025. For further inquiries, applicants can contact Nordia Williams at (240) 475-3310 or via email at Nwilliams1@hrsa.gov.