IL Dept of Healthcare and Family Services

The Cell and Gene Therapy (CGT) Access Model aims to improve the lives of people living with rare and severe diseases by increasing access to potentially transformative treatments. It is a multi-year, voluntary model for states and manufacturers to test whether a CMS-led approach to developing and administering outcomes-based agreements (OBAs) for cell and gene therapies increases Medicaid beneficiaries’ access to innovative treatment, improves their health outcomes, and reduces health care costs and burden to state Medicaid programs. The initial focus of the model is on access to gene therapy treatments for people living with sickle cell disease, a genetic blood disorder.

Section 1115A of the Social Security Act

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HFS will use federal award funding to implement the Model, which supports staff, research, and Community-Based Organization (CBO) efforts to improve Medicaid beneficiary access to sickle cell disease (SCD) gene therapies. Funding will expand wraparound services such as patient education, screenings, care coordination, and supports like childcare, nutrition, and lodging to address barriers before and after treatment.

Yes

All relevant program requirements and definitions outlined in HFS federal award will apply to any related subawards and will be incorporated in the terms and conditions of the agreements.

Nonprofit Organizations;

Federal funds were received by HFS as a State Medicaid Agency. HFS will partner with an Illinois community-based organization that serves individuals living with sickle cell disease. Organization must have the capacity to provide educational materials and care coordination services related to CGT Access Model and the treatment of sickle cell disease.

The Cell and Gene Therapy Access Model beneficiaries are Medicaid-eligible individuals with sickle cell disease.

Cooperative Agreements

Healthcare

Registration and pre-qualification through the Grant Accountability and Transparency Act (GATA) Grantee Portal, www.grants.illinois.gov/portal.

Registration and pre-qualification through the Grant Accountability and Transparency Act (GATA) Grantee Portal, www.grants.illinois.gov/portal.

The potential applicant will be contacted directly by the Department and provided additional information regarding the application requirements and necessary documentation needed to submit a complete application packet. The grantee will be required to demonstrate how it will spend the funds received. There is only one experienced nonprofit organization who provides education and care coordination services to individuals with sickle cell disease in Illinois.

The potential applicant will be contacted directly by the Department and provided additional information regarding the application requirements and necessary documentation needed to submit a complete application packet. The grantee will be required to demonstrate how it will spend the funds received. There is only one experienced nonprofit organization who provides education and care coordination services to individuals with sickle cell disease in Illinois.

The Department will make direct contact with Award recipient. There is only one experienced nonprofit organization who provides education and care coordination services to individuals with sickle cell disease in Illinois. Based on the number of eligible entities, this will not be a competitive grant, and a merit-based review would not be necessary.

Application deadline is to be determined

Department approval or disapproval time could take up to 30 business days.

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Grant agreements are subject to appropriations and receipt of federal funds.

None

Applicants may request Implementation Funding for activities that are necessary to implement requirements of the Model, as outlined in Section A6.5 State Requirements. Such activities may include, but are not limited to: • Developing new State statutory authorities or State Plan Amendments (SPAs). • Expanding Medicaid staff capacity/personnel, or hiring subrecipients or contractors to improve the quality, completeness, and timeliness of T-MSIS claims data submissions, or implement other aspects of the Model. • Conducting outreach to and engaging with interested parties, who may be impacted by the Model. • Establishing and maintaining agreements with managed care plans and in-state/out-of-state gene therapy providers. Applicants may also request Implementation Funding for optional activities that would increase access to SCD gene therapy and promote multi-disciplinary, comprehensive care for beneficiaries with SCD who are considering, or undergoing, gene therapy. Such optional activities may include (see Section A6.6 Optional State Activities): • Staff time and infrastructure costs related to expanding or increasing Medicaid benefits or reimbursement rates (including through the Optional Benefit for Sickle Cell Disease). • Staff time and infrastructure costs related to gene therapy for sickle cell disease outreach and education campaigns. • Partnering with CBOs that are designated to carry out optional Model activities (e.g., conducting screening to address access barriers patients may experience; providing peer support; raising awareness and improving education among hematologists and beneficiaries with SCD about gene therapy) Applicants may request Milestone Funding for 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 (see Section A6.8.2 Milestone Funding). Milestone Funding will be restricted and is not guaranteed. If a Recipient meets the requirements to warrant release of Milestone Funding, the funding may be used to reimburse the costs incurred to conduct the research project. Funding cannot be used: • For any direct service provision that is already paid for by another federal, state or local program • To reimburse providers for the provision of Medicaid-funded services. • To duplicate or supplant other funding sources. For example, Cooperative Agreement funding cannot be used in the following ways: o Paying for partnerships with CBOs that already existed prior to participation in the Model (unless, and only to the extent that, the partnerships will be more extensive/costly under the Model). o Paying for CBO activities that the State already carries out (e.g., screening and referral related to access barriers a patient may experience). o Paying for data collection activities and T-MSIS improvements that were planned using alternate funding sources prior to participation in the Model. Prohibited Uses of Award Funds CMS prohibits funds under this award for any of the activities/costs outlined below unless an exception is specifically authorized by statute. • To reimburse for pre-award costs. • To match any other Federal funds. • To provide services, equipment, or supports that are the legal responsibility of another party under Federal, State, or Tribal law (e.g., vocational rehabilitation or education services) or under any civil rights laws. Such legal responsibilities include, but are not limited to, modifications of a workplace or other reasonable accommodations that are a specific obligation of the employer or other party. • To provide goods or services not allocable to the approved project. • To supplant existing State, local, Tribal or private funding of infrastructure or services, such as staff salaries, etc. • To be used by local entities to satisfy state matching requirements. • To pay for construction. • To pay for capital expenditures for improvements to land, buildings, or equipment which materially increase their value or useful life as a direct cost, except with the prior written approval of the Federal awarding agency. • To pay for the cost of independent research and development, including their proportionate share of indirect costs (unallowable in accordance with 45 CFR 75.476). • To expend funds related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive Order proposed or pending before the Congress or any state government, state legislature or local legislature or legislative body in accordance with 45 CFR 75.450 and 45 CFR Part 93. • To pay for certain telecommunications and video surveillance equipment. See 2 CFR 200.216 to make sure this does not apply to any proposed equipment in your application. • To pay for meals unless in limited circumstances such as: o Subjects and patients under study. o Where specifically approved as part of the project or program activity (not grantee specific); and o As part of a per diem or subsistence allowance provided in conjunction with allowable travel. o Under the assurance of transportation, per the assurance of transportation in section 1902(a)(4)(a) of the SSA.41 • To pay for any direct service provision that is already paid for by another federal, state or local program. • To reimburse providers for the provision of Medicaid-funded services already covered by Medicaid. • To duplicate or supplant other funding sources.

The CBO will report activities to HFS monthly and assist with quarterly reporting under this cooperative agreement. The CBO also will provide reporting, as requested, to support the milestone funding under this cooperative agreement that will inform the evolution of the non-Medicaid-covered wraparound services and supports provided by the CBO. Some required reporting metrics include: Awareness, Education, and Access to Specialty Care: - The number of educational meetings and events hosted by the CBO funded by the cooperative agreement to support awareness, education, and access to specialty care. - The number of providers registered with Illinois Medicaid who received training via the CBO in BP1. - The number of managed care staff who received training via the CBO in BP1. - The number of beneficiaries with SCD referred to Medicaid-covered peer support services by the CBO. - CBO activities funded by the cooperative agreement that support connections to and services supporting non-Medicaid covered peer supports for patients with SCD (unrelated to SUD). Access Barriers: - For each service type, the number of beneficiaries with SCD receiving direct, non-Medicaid covered services from the CBO funded under the cooperative agreement to address access barriers to care. - The number of beneficiaries with SCD receiving housing and nutrition support services under the state's 1115 waiver. Care Coordination: - The number of beneficiaries with SCD receiving direct services from or referrals to CHWs, navigators, or peer supports through the cooperative agreement funded CBO. - The number of beneficiaries with SCD receiving Medicaid-covered CHW services after SPA approval and implementation. Family Planning: - The number of beneficiaries with SCD receiving Medicaid-covered fertility preservations services beyond the services covered by participating Manufacturers.

Grantees must comply with the audit requirements listed in 2 CFR 200 and Administrative Rule, 44 Illinois Administrative Code 7000.90.

Grantees must maintain for three (3) years from the date of submission of the final expenditure report, adequate books, all financial records and, supporting documents, statistical records, and all other records pertinent to this Award, adequate to comply with 2 CFR 200.334 and 44 Ill. Admin. Code 7000.430(a) and (b).

TBD

$1,456,400 for Fiscal Year 2026 (estimated)

HFS has received $9.55 million from the Centers for Medicare & Medicaid Services over a 10-year period. Partner agreements will vary for each year of the program.

1. HFS will carry-out the required Model activities in-house for the Model implementation plan. 2. HFS will implement optional initiatives aimed at expanding access to SCD gene therapy and fostering multidisciplinary, comprehensive care for beneficiaries with SCD who are potential candidates for or recipients of SCD CGT. 3. HFS Plans to Expand Medicaid Services, including Policy Changes. 4. The state’s implementation plan encompasses support for populations that live far from hematologists, gene therapy providers, and other providers that are critical to successful completion of the gene therapy journey for individuals with SCD. The CBO scope of work focuses on raising awareness and improving education around sickle cell disease (SCD), addressing access barriers through screening, referrals, and direct services, and financing wraparound supports not covered by Medicaid, such as childcare, transportation, housing, and nutrition. It also includes developing infrastructure, funding community health workers (CHWs) and peer supports, and building capacity within community-based organizations and providers to better serve individuals with SCD.

https://www.cms.gov/cell-and-gene-therapy-cgt-access-model

Statewide

Springfield, IL

Program specific page will be added to https://hfs.illinois.gov/.

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FY 2026 : $1,456,400
FY 2027 : $1,323,200
FY 2028 : $1,323,200
FY 2029 : $1,323,200
FY 2030 : $1,323,200
FY 2031 : $1,323,200