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
    Connecting Kids to Coverage Outreach and Enrollment Cooperative Agreements (CKC) 2025
    Centers for Medicare & Medicaid Services
    The Centers for Medicare & Medicaid Services (CMS) is inviting applications for the Connecting Kids to Coverage (CKC) Outreach and Enrollment Cooperative Agreements program, aimed at enrolling and retaining eligible children in Medicaid and the Children's Health Insurance Program (CHIP). The program seeks to target eligible, unenrolled children while also improving retention rates for those already enrolled, with a total funding pool of $66.3 million available for up to 22 recipients, each potentially receiving up to $3 million. Eligible applicants include state and local governments, educational institutions, and nonprofit organizations, emphasizing the importance of outreach and measurable outcomes over a five-year period. Applications are due by March 7, 2025, and interested parties can contact HealthyKids@cms.hhs.gov for further information.
    Notice of Intent to Publish a Funding Opportunity Announcement for Somatic Cell Genome Editing Translational Coordination and Dissemination Center (U24, Clinical Trial Not Allowed)
    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.
    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)
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for the Ultra-Rare Gene-based Therapy (URGenT) Network Resource Access program under funding opportunity number PAR-25-326. This initiative aims to facilitate access to contract research organizations and subject matter experts to support nonclinical development activities for gene-based therapies targeting ultra-rare neurological and neuromuscular diseases. The program emphasizes the urgency of developing tailored therapies due to the critical nature of these conditions and the lack of existing commercial therapeutic options, encouraging proposals that demonstrate proof of concept data for defined patient populations. Applications are accepted on a rolling basis, with a close date of January 31, 2028, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries. Additional details can be found at the provided link: https://grants.nih.gov/grants/guide/pa-files/PAR-25-326.html.
    Minority Research Grant Program (MRGP) 2025
    Centers for Medicare & Medicaid Services
    The Centers for Medicare & Medicaid Services (CMS) is offering the Minority Research Grant Program (MRGP) for 2025, aimed at funding innovative health equity research projects that improve health outcomes for minority populations. This program encourages research that addresses social determinants of health and aims to reduce health disparities at the healthcare system level, with a total funding pool of $1,275,000 and individual grants available up to $212,500 for projects lasting 24 months. Eligible applicants include various institutions serving minority populations, such as Historically Black Colleges and Universities and Tribal Colleges, and must adhere to specific application guidelines, including a project narrative and a minimum cost-sharing requirement of 1%. Interested parties should submit their applications via Grants.gov by April 1, 2025, with an optional letter of intent due by March 6, 2025; for further inquiries, contact OMHgrants@cms.hhs.gov.
    Translational Efforts to Advance Gene-based Therapies for Ultra-Rare Neurological and Neuromuscular Disorders (U01 - Clinical Trial Optional)
    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" (PAR-25-327), aimed at supporting Investigational New Drug (IND)-enabling studies and preparations for First-in-Human (FIH) clinical trials. This initiative focuses on advancing innovative gene-based therapies, such as oligonucleotides and viral vector approaches, for ultra-rare disorders affecting fewer than 6,000 patients, with an emphasis on projects that demonstrate robust proof of concept data and readiness for clinical trials. Eligible applicants include a wide range of organizations, including higher education institutions and various nonprofit and for-profit entities, with applications requiring detailed project planning and compliance with Good Manufacturing Practices (GMP). The application period opens on January 9, 2025, with a close date of October 8, 2027, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    Hereditary Hemorrhagic Telangiectasia (HHT) Center
    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.
    Medical Monitoring Project
    Centers for Disease Control - NCHHSTP
    The Centers for Disease Control and Prevention (CDC) is forecasting a funding opportunity for the Medical Monitoring Project (MMP), aimed at enhancing the understanding of the experiences and needs of adults diagnosed with HIV in the United States. This initiative involves a comprehensive surveillance system that collects clinical and behavioral data through interviews and medical chart abstractions, providing valuable insights for prevention planning, policy-making, and resource advocacy. With an estimated total program funding of $70.5 million and the expectation of awarding 23 cooperative agreements, eligible applicants include state health departments and select local health departments, with applications due by January 31, 2025. For further inquiries, interested parties can contact Jason Craw at (404) 639-6395 or via email at emf4@cdc.gov.
    Center for Research on Complex Generics (U18) Clinical Trials Optional
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity for the establishment of a Center for Research on Complex Generics through a cooperative agreement. This initiative aims to enhance collaboration with the generic drug industry, focusing on identifying scientific challenges in generic product development and facilitating research that supports the FDA's mission to improve patient access to high-quality, safe, and effective generic drugs. The Center will serve as a hub for coordination among FDA, academia, and industry stakeholders, conducting research, hosting workshops, and providing public access to research outcomes. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or by phone at 240-402-7610. The funding amount is set at $1.5 million, with one award anticipated for the fiscal year 2025.
    Advancing Genomic Medicine Research (R21 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Advancing Genomic Medicine Research (R21 Clinical Trial Optional)" aimed at stimulating innovation in the application of genomic information in clinical care, particularly for populations experiencing health disparities. The initiative seeks to enhance understanding of how to effectively implement and share genomic technologies across diverse communities, including racial and ethnic minorities, underserved rural populations, and sexual and gender minority groups. With an expected total funding of approximately $1.5 million for fiscal year 2024, individual project budgets may reach up to $250,000. Interested applicants must submit their proposals by February 11, 2025, and can find additional details and guidelines at the NIH grants website or contact NIH Grants Information at grantsinfo@nih.gov for further inquiries.