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| 49 | 64 | | An Act |
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| 53 | 68 | | establishing the prescription digital therapeutics pilot program in the department of health services; appropriating monies. |
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| 59 | 74 | | (TEXT OF BILL BEGINS ON NEXT PAGE) |
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| 63 | 78 | | Be it enacted by the Legislature of the State of Arizona: Section 1. Prescription digital therapeutics pilot program; requirements; report; delayed repeal; definition A. The prescription digital therapeutics pilot program is established in the department of health services. The department shall contract with a vendor to procure FDA-authorized prescription digital therapeutics that are approved for the treatment of substance use disorder and opioid use disorder to explore the effectiveness of the prescription digital therapeutic. Under the pilot program, the department shall provide the prescription digital therapeutic to patients who have been diagnosed with a substance use disorder or opioid use disorder and prescribed an FDA-authorized prescription digital therapeutic as part of treatment by treating health care providers who are participating in the pilot program. B. The use of FDA-authorized prescription digital therapeutics by participating patients may be in addition to any other treatment for substance use disorder and opioid use disorder, including medication-assisted treatment and other behavioral health services. C. The pilot program shall begin not later than October 1, 2023 and shall be operated until October 1, 2025 or until the monies appropriated for the program are spent, whichever occurs first. D. Within six months after the termination of the pilot program, the department of health services shall prepare a report, using data supplied by the contracted vendor of the FDA-authorized prescription digital therapeutics and aggregated claims data, describing the department's findings regarding the impact of the pilot program. The department shall submit the report to the chairpersons and ranking minority party members of the health and human services committees of the senate and the house of representatives, or their successor committees. A copy of the report shall be provided to the secretary of state. The report shall describe at least all the following: 1. The population included in the pilot program. 2. The successes and challenges of the pilot program. 3. Participant treatment goals and whether those goals were achieved. 4. A comparison of hospitalization for program participants as compared to other patients of the participating treating health care providers who are being treated for substance use disorders and opioid use disorders. 5. An explanation of whether and how the prescription digital therapeutics prescribed to pilot program participants improved their access to treatment. E. This section is repealed from and after December 31, 2026. F. For the purposes of this section, "FDA-authorized prescription digital therapeutic" or "prescription digital therapeutic" means a product, device, internet application or other technology that meets all of the following requirements: 1. Is intended to prevent, manage or treat a medical disease, condition or disorder. 2. Is approved, cleared or classified by the United States food and drug administration under section 510(k), 513(f) or 515 of the federal food, drug, and cosmetic act for such intended use. 3. Uses both cognitive behavioral therapy and contingency management in the product to treat substance use disorder or opioid use disorder. 4. Requires a prescription under 21 Code of Federal Regulations section 801.109 or any successor regulation. Sec. 2. Appropriation; prescription digital therapeutics pilot program; exemption A. The sum of $10,000,000 is appropriated from the monies that are governed by the One Arizona Distribution of Opioid Settlement Funds Agreement in fiscal year 2023-2024 to the department of health services to purchase prescription digital therapeutics that are authorized by the United States food and drug administration to treat substance abuse disorder and opioid use disorder for the prescription digital therapeutics pilot program established by this act. B. The monies appropriated pursuant to subsection A of this section are exempt from the provisions of section 35-190, Arizona Revised Statutes, relating to lapsing of appropriations, except that any monies remaining unexpended and unencumbered on December 31, 2026 revert to the state general fund. |
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| 65 | 80 | | Be it enacted by the Legislature of the State of Arizona: |
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| 66 | 81 | | |
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| 67 | 82 | | Section 1. Prescription digital therapeutics pilot program; requirements; report; delayed repeal; definition |
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| 68 | 83 | | |
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| 69 | 84 | | A. The prescription digital therapeutics pilot program is established in the department of health services. The department shall contract with a vendor to procure FDA-authorized prescription digital therapeutics that are approved for the treatment of substance use disorder and opioid use disorder to explore the effectiveness of the prescription digital therapeutic. Under the pilot program, the department shall provide the prescription digital therapeutic to patients who have been diagnosed with a substance use disorder or opioid use disorder and prescribed an FDA-authorized prescription digital therapeutic as part of treatment by treating health care providers who are participating in the pilot program. |
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| 70 | 85 | | |
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| 71 | 86 | | B. The use of FDA-authorized prescription digital therapeutics by participating patients may be in addition to any other treatment for substance use disorder and opioid use disorder, including medication-assisted treatment and other behavioral health services. |
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| 72 | 87 | | |
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| 73 | 88 | | C. The pilot program shall begin not later than October 1, 2023 and shall be operated until October 1, 2025 or until the monies appropriated for the program are spent, whichever occurs first. |
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| 74 | 89 | | |
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| 75 | 90 | | D. Within six months after the termination of the pilot program, the department of health services shall prepare a report, using data supplied by the contracted vendor of the FDA-authorized prescription digital therapeutics and aggregated claims data, describing the department's findings regarding the impact of the pilot program. The department shall submit the report to the chairpersons and ranking minority party members of the health and human services committees of the senate and the house of representatives, or their successor committees. A copy of the report shall be provided to the secretary of state. The report shall describe at least all the following: |
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| 76 | 91 | | |
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| 77 | 92 | | 1. The population included in the pilot program. |
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| 78 | 93 | | |
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| 79 | 94 | | 2. The successes and challenges of the pilot program. |
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| 80 | 95 | | |
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| 81 | 96 | | 3. Participant treatment goals and whether those goals were achieved. |
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| 82 | 97 | | |
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| 83 | 98 | | 4. A comparison of hospitalization for program participants as compared to other patients of the participating treating health care providers who are being treated for substance use disorders and opioid use disorders. |
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| 84 | 99 | | |
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| 85 | 100 | | 5. An explanation of whether and how the prescription digital therapeutics prescribed to pilot program participants improved their access to treatment. |
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| 86 | 101 | | |
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| 87 | 102 | | E. This section is repealed from and after December 31, 2026. |
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| 88 | 103 | | |
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| 89 | 104 | | F. For the purposes of this section, "FDA-authorized prescription digital therapeutic" or "prescription digital therapeutic" means a product, device, internet application or other technology that meets all of the following requirements: |
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| 90 | 105 | | |
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| 91 | 106 | | 1. Is intended to prevent, manage or treat a medical disease, condition or disorder. |
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| 92 | 107 | | |
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| 93 | 108 | | 2. Is approved, cleared or classified by the United States food and drug administration under section 510(k), 513(f) or 515 of the federal food, drug, and cosmetic act for such intended use. |
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| 94 | 109 | | |
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| 95 | 110 | | 3. Uses both cognitive behavioral therapy and contingency management in the product to treat substance use disorder or opioid use disorder. |
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| 96 | 111 | | |
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| 97 | 112 | | 4. Requires a prescription under 21 Code of Federal Regulations section 801.109 or any successor regulation. |
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| 98 | 113 | | |
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| 99 | 114 | | Sec. 2. Appropriation; prescription digital therapeutics pilot program; exemption |
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| 100 | 115 | | |
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| 101 | 116 | | A. The sum of $10,000,000 is appropriated from the monies that are governed by the One Arizona Distribution of Opioid Settlement Funds Agreement in fiscal year 2023-2024 to the department of health services to purchase prescription digital therapeutics that are authorized by the United States food and drug administration to treat substance abuse disorder and opioid use disorder for the prescription digital therapeutics pilot program established by this act. |
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| 102 | 117 | | |
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| 103 | 118 | | B. The monies appropriated pursuant to subsection A of this section are exempt from the provisions of section 35-190, Arizona Revised Statutes, relating to lapsing of appropriations, except that any monies remaining unexpended and unencumbered on December 31, 2026 revert to the state general fund. |
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