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Policy Priorities

Today, we spend 85 cents of every healthcare dollar managing the symptoms of chronic illnesses over a patient’s lifetime. Gene therapies are potential one-time treatments that offer long-lasting benefits for patients and the healthcare system alike. We must think anew about how they are covered and paid for.

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IGT ADVOCATES FOR:

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Ensuring Patient Access to Gene Therapies

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Modernizing the Reimbursement for Gene Therapies

Preserving & Strengthening FDA’s Accelerated
Approval Pathway

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Improving Access to Newborn Screening

Equipping the FDA to Advance Gene Therapies

Understanding the Value of Gene Therapies

The FDA has prioritized the acceleration of gene and cell therapy approvals and expects to receive over 200 investigational new drug applications (INDs) each year.

The current reimbursement system will not be able to accommodate the influx of approvals, which will adversely impact patient access. To help ensure these transformational therapies can be approved in a timely way and patients can access them when they are available, novel development pathways need to be embraced and new value-based arrangements must be tested.

IGT COMMENTS ON POLICY PROPOSALS

2024

IGT/ARM Stakeholder Letter to Congress on reauthorization of the Rare Pediatric Disease Priority Review Voucher Program, the Medicaid Value-Based Payments for Patients (MVP) Act, and the Accelerating Kids’ Access to Care Act (November 13, 2024)

IGT Comments on CMS FY 2025 IPPS Proposed Rule (June 10, 2024)

2023

IGT Comments on CMMI Cell and Gene Therapy (CGT) Access Model Considerations
(December 19, 2023)
IGT Comments on Discrimination on the Basis of Disability in Health and Human Service Programs or Activities [HHS–OCR–2023–0013] (November 13, 2023)
IGT Comments on Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program [CMS-2434-P]
(July 25, 2023)
IGT Comments on FY 2024 IPPS Proposed Rule [CMS-1785-P]
(June 9, 2023)
IGT Applauds Introduction of the Medicaid VBPs for Patients Act, or the MVP Act (H.R. 2666)(April 24, 2023)
IGT Comments on the EEOC Draft Strategic Enforcement Plan for FYs 2023-2027
[EEOC-2022-0006](February 9, 2023)

2022

IGT Comments to the FDA on the FDA CBER OTAT Patient-Focused Drug Development Listening Meeting – Patient Perspectives on Gene Therapy Products (December 15, 2022)
IGT Comments to the US EEOC Strategic Plan 2022-2026; Preliminary Draft
(December 5, 2022)
IGT Comments on the Nondiscrimination in Health Programs and Activities Proposed Rule (RIN 0945-AA17) (October 3, 2022)
IGT Comments to CMS re: Establishing IGT Gene Therapy Policy Proposal for the Fiscal Year 2023 Medicare Inpatient Prospective Payment System Proposed Rule
(July 20, 2022)
IGT Comments on Fiscal Year 2022 Hospital Inpatient Prospective Payment System Proposed Rule (June 16, 2022)
IGT Comments to CMS on Application for Renewal and Amendment to the Oregon Health Plan Section 1115 Demonstration Waiver (April 13, 2022)

2021

IGT Comments on 21st Century Cures 2.0 Discussion Draft (July 23, 2021)
IGT Gene Therapy Policy Proposal for the Fiscal Year 2022 Medicare Inpatient Prospective Payment System Proposed Rule (June 28, 2021)
IGT Considerations for NIH NCATS RFI “Facilitating the Early Diagnosis and Equitable Delivery of Gene-Targeted Therapies to Individuals with Rare Diseases” (May 28, 2021)
MACPAC’s Draft Recommendations on Accelerated Approval Drugs (April 5, 2021)
IGT Comments on Most Favored Nation Model Interim Final Rule with Comment Period
(CMS-5528-IFC) (January 26, 2021)

2020

IGT Gene Therapy Policy Proposal for CMS Fiscal Year 2021 Medicare Inpatient Prospective Payment System Proposed Rule (December 18, 2020)
IGT Comments on CMS Proposed Rule on MCIT and Definition of “Reasonable and Necessary” (November 2, 2020)
IGT Comments on CMS Proposed Rule on Value-based Purchasing Arrangements
(July 20, 2020)
IGT Comments on 21st Century Cures 2.0 Concept Paper (June 12, 2020)
IGT Feedback to CMS re: RFI on “Coordinating Care from Out-of-State Providers for Medicaid-Eligible Children with Medically Complex Conditions.” (June 1, 2020)

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