LEGISLATIVE SERVICES AGENCY
OFFICE OF FISCAL AND MANAGEMENT ANALYSIS
200 W. Washington St., Suite 301
Indianapolis, IN 46204
(317) 233-0696
iga.in.gov
FISCAL IMPACT STATEMENT
LS 6360 NOTE PREPARED: Dec 11, 2023
BILL NUMBER: HB 1184 BILL AMENDED:
SUBJECT: Breakthrough Therapies.
FIRST AUTHOR: Rep. Moed BILL STATUS: As Introduced
FIRST SPONSOR:
FUNDS AFFECTED:XGENERAL IMPACT: State & Local
XDEDICATED
XFEDERAL
Summary of Legislation: This bill establishes the Breakthrough Therapies Research Fund. It provides that
a drug, biological product, or medical device that has been designated as a breakthrough therapy under
federal law may be made available to a qualified patient and offered by a physician as a part of the patient's
medical treatment. It also specifies that a civil or criminal cause of action is not created against a
manufacturer or health care provider for any harm to a qualified patient resulting from use of an
investigational drug, biological product, or device.
Effective Date: July 1, 2024.
Explanation of State Expenditures: Breakthrough Therapies Research Fund: This bill establishes the non-
reverting Breakthrough Therapies Research Fund (fund) to provide financial assistance to research
institutions in Indiana to study breakthrough therapies for treating serious mental illness. The fund will be
administered by the Indiana Department of Health (IDOH) and may consist of appropriations from the
General Assembly, as well as donations or gifts made to the fund. Expenses for administering the fund are
to be paid from money in the fund.
Any increase in General Fund expenditures will depend upon appropriations made to the fund by the General
Assembly. Administering the fund is within the IDOH’s routine administrative functions and should be able
to be implemented with no additional appropriations, assuming near customary agency staffing and resource
levels. [The IDOH’s administrative expenditures are currently paid from the Tobacco Master Settlement
Fund, a dedicated fund.]
Medicaid and State Employee Health Plan: This bill is silent with regard to the routine care costs for when
HB 1184 1 a breakthrough therapy is provided to an individual covered by Medicaid or the state employee health plan.
Any potential impact to state expenditures for Medicaid or the state employee health plan would depend on
the number and frequency of use of breakthrough therapies and the difference in cost between a breakthrough
therapy and the therapy that would have otherwise been provided.
Medical Licensing Board: The Medical Licensing Board will need to develop protocols for the use of
breakthrough therapies in a setting other than an inpatient or outpatient hospital setting. This requirements
may be completed within the regularly scheduled meetings of the board.
Additional Information: Current state law allows the use of investigational or experimental drugs, biological
products, and medical devices that have successfully completed Phase I of a federal Food and Drug
Administration (FDA) approved clinical trial but have not been approved for general use by the FDA.
This bill does not require an insurer, fraternal benefit society, nonprofit corporation, health maintenance
organization, preferred provider arrangement, or limited service health maintenance organization to provide
coverage or make payments beyond the terms and conditions of their contracts for medical treatment.
On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into
law. FDASIA Section 902 provides for the new designation of Breakthrough Therapy, which includes a drug
that is (1) intended to treat a serious or life threatening disease or condition and (2) preliminary clinical
evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one
or more clinically significant endpoints, such as substantial treatment effects observed early in clinical
development. From July 9, 2012, through December 31, 2022, the FDA received a total of 1,289 requests
for Breakthrough Therapy designation with 502 being granted.
Explanation of State Revenues:
Explanation of Local Expenditures: The governing board for a locally owned hospital must approve the
types of experimental or non-conventional medical treatments that may be provided at the hospital on an
inpatient or outpatient basis. This is a routine administrative function of hospitals.
Explanation of Local Revenues:
State Agencies Affected: Indiana Department of Health; Medical Licensing Board, Professional Licensing
Agency; Office of Medicaid Policy and Planning, Family and Social Services Administration; State
Personnel Department.
Local Agencies Affected: Locally owned hospitals.
Information Sources: Food and Drug Administration;
https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdas
ia/frequently-asked-questions-breakthrough-therapies.
Fiscal Analyst: Jason Barrett, 317-232-9809.
HB 1184 2