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ARIZONA STATE SENATE
Fifty-Sixth Legislature, First Regular Session
prescription digital therapeutics; pilot program
Purpose
Establishes the Prescription Digital Therapeutics Pilot Program (Program) to explore the effectiveness of the U.S. Food and Drug Administration (FDA) authorized prescription digital therapeutics (therapeutics). Appropriates $10,000,000 from the monies governed by the One Arizona Distribution of Opioid Settlement Funds Agreement (Agreement), in FY 2024, to the Department of Health Services (DHS) to purchase therapeutics to treat substance abuse disorder and opioid use disorder under the Program.
Background
DHS's mission is
to promote, protect and improve the health and wellness of individuals and
communities in Arizona. DHS operates programs in the following areas to achieve
this mission: 1) disease prevention and control; 2) health promotion; 3)
community public health;
4) environmental health; 5) maternal and child health; 6) emergency
preparedness; and
7) regulation of healthcare institutions and facilities (DHS).
In 2021, 90 cities and towns and all 15 counties signed the Agreement which ensures that Arizona will receive the maximum amount of money available from future opioid settlements. The Agreement provides funding for programs to address and ameliorate opioid abuse and includes reporting requirements for greater transparency of how money is used. The Agreement requires that 56 percent of the total settlement go to local governments for opioid amelioration programs and 44 percent of the total settlement go to a state fund for opioid amelioration programs. Funds must be spent in accordance with approved, nationally recognized strategies to pay for future costs incurred by the state and local governments to address the opioid epidemic, including transparent reporting requirements for fund usage to ensure compliance with approved purposes. Lastly, fund monies provide flexibility for local governments to pool resources to increase the impact of settlement funds (Agreement).
The Federal Food, Drug and Cosmetic Act (Act) allows a person to submit, to the U.S. Secretary of the Department of Health and Human Services (Secretary), an application or submission for a product to receive an FDA classification for regulation. Within 60 days of the receipt of the request, the Secretary must determine the classification of the product that the FDA will then regulate (Act).
H.B. 2451 appropriates $10,000,000 from the monies governed by the Agreement, in FY 2024, to DHS.
Provisions
1. Establishes the Program within DHS to provide therapeutics to patients that have been diagnosed with a substance use disorder or opioid use disorder and been prescribed therapeutics as part of treatment by treating health care providers who are participating in the Program.
2. Requires DHS to contract with a vendor to procure therapeutics that are approved for the treatment of substance use disorder and opioid use disorder to explore the therapeutic effectiveness.
3. Allows the use of therapeutics to be in addition to any other treatment for substance use disorder and opioid use disorder, including medication-assisted treatment and other behavioral health services.
4. Requires the Program to begin by October 1, 2023, and operate until October 1, 2025, or until the monies appropriated for the Program are spent, whichever occurs first.
5. Requires DHS, within six months after the Program's termination, to prepare a report describing DHS's findings regarding the Program's impact using data supplied by the therapeutics contracted vendor and aggregated claims data.
6. Requires DHS to submit the DHS report to the Chairpersons and Ranking Minority Party Members of the Senate and the House of Representatives Health and Human Services Committees, or their successor committees, and a provide copy of the report to the Secretary of State.
7. Requires the DHS report to describe, at least:
a) the population included in the Program;
b) Program successes and challenges;
c) participant treatment goals and whether those goals were achieved;
d) a comparison of hospitalization for Program participants compared to other patients of the participating treating health care providers who are being treated for substance use disorders and opioid use disorders; and
e) an explanation of whether and how the therapeutics prescribed to Program participants improved their access to treatment.
8. Repeals the Program on January 1, 2027.
9. Defines FDA-authorized prescription digital therapeutic or prescription digital therapeutic as a product, device, internet application or other technology that:
a) is intended to prevent, manage or treat a medical disease, condition or disorder;
b) is approved, cleared or classified by the FDA under the Act for such intended use;
c) uses both cognitive behavioral therapy and contingency management in the product to treat substance use disorder or opioid use disorder; and
d) requires a prescription under FDA regulation or any successor regulation.
10. Appropriates $10,000,000 from the monies that are governed by the Agreement, in FY 2024, to DHS to contract with a vendor to purchase therapeutics that are approved for the treatment of substance abuse disorder and opioid use disorder under the Program.
11. Exempts the appropriation from lapsing.
12. Reverts any remaining unexpended and unencumbered monies on December 31, 2026, to the state General Fund.
13. Becomes effective on the general effective date.
House Action
HHS 2/6/23 DP 8-1-0-0
3rd Read 2/22/23 37-23-0
Prepared by Senate Research
March 10, 2023
MM/MC/slp