Arizona 2024 Regular Session

Arizona House Bill HB2659 Compare Versions

Only one version of the bill is available at this time.

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1	1	REFERENCE TITLE: prescription drugs; importation program State of Arizona House of Representatives Fifty-sixth Legislature Second Regular Session 2024 HB 2659 Introduced by Representatives Shah: Biasiucci, Carbone, Pingerelli; Senators Shamp, Shope An Act amending title 36, Arizona Revised Statutes, by adding chapter 33; relating to prescription drugs. (TEXT OF BILL BEGINS ON NEXT PAGE)
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9	9	REFERENCE TITLE: prescription drugs; importation program
10	10	State of Arizona House of Representatives Fifty-sixth Legislature Second Regular Session 2024
11	11	HB 2659
12	12	Introduced by Representatives Shah: Biasiucci, Carbone, Pingerelli; Senators Shamp, Shope
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14	14	REFERENCE TITLE: prescription drugs; importation program
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40	40	HB 2659
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46	46	Representatives Shah: Biasiucci, Carbone, Pingerelli; Senators Shamp, Shope
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64	64	An Act
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68	68	amending title 36, Arizona Revised Statutes, by adding chapter 33; relating to prescription drugs.
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74	74	(TEXT OF BILL BEGINS ON NEXT PAGE)
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78	78	Be it enacted by the Legislature of the State of Arizona: Section 1. Title 36, Arizona Revised Statutes, is amended by adding chapter 33, to read: CHAPTER 33 WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM ARTICLE 1. GENERAL PROVISIONS START_STATUTE36-3301. Definitions In this article, unless the context otherwise requires: 1. "Department" means the department of health services. 2. "Program" means the wholesale prescription drug importation program. 3. "340B covered entity" and "340B drug pricing program" have the same meanings prescribed in section 36-2930.03.END_STATUTE START_STATUTE36-3302. Importation of prescription drugs; program design; funding design; submittal A. The department, in consultation with interested stakeholders and appropriate federal officials, shall design a wholesale prescription drug importation program that complies with the applicable requirements of 21 United States code section 384, including the requirements regarding safety and cost savings. The program design shall: 1. Require the department to either become a licensed drug wholesaler or contract with a licensed drug wholesaler in order to seek federal certification and approval to import safe prescription drugs and provide significant prescription drug cost savings to consumers. 2. Use Canadian prescription drug suppliers that are regulated under the laws of Canada or one or more Canadian provinces, or both. 3. Ensure that only prescription drugs meeting the United States food and drug administration's safety, effectiveness and other standards are imported by or on behalf of this state. 4. Import only those prescription drugs that are expected to generate substantial savings for consumers in this state. 5. Ensure that the program complies with the tracking and tracing requirements of 21 United States Code sections 360eee and 360eee-1 to the extent feasible and practicable before imported drugs come into the possession of this state's wholesaler and that the program fully complies with these requirements after imported drugs are in the possession of this state's wholesaler. 6. Prohibit the distribution, dispensing or sale of imported drugs outside of this state. 7. Recommend a charge per prescription or another method of support to ensure that the program is adequately funded in a manner that does not jeopardize significant consumer savings. 8. Include a robust audit protocol. B. The department shall recommend a funding design for the program and submit the funding design and the program design to the governor, the president of the senate and the speaker of the house of representatives. END_STATUTE START_STATUTE36-3303. Attorney general consultation; certification request; federal approval; limit on implementation The department shall: 1. Consult with the attorney general's office to identify the potential for and to monitor anticompetitive behavior in industries that would be affected by a wholesale prescription drug importation program in this state. 2. Submit a formal request to the secretary of the United States department of health and human services for certification of this state's wholesale prescription drug importation program. 3. Seek the appropriate federal approvals, waivers, exemptions or agreements as needed to enable 340B covered entities that are enrolled in or eligible for the federal 340B drug pricing program to participate in this state's wholesale prescription drug importation program to the fullest extent possible without jeopardizing their eligibility for the 340B drug pricing program. 4. Not implement the wholesale prescription drug importation program until the legislature enacts legislation that establishes either a charge per prescription or another source of program funding. END_STATUTE START_STATUTE36-3304. Program implementation The department shall begin implementing and operating the program within six months after the later of either the legislature enacting a method of program funding pursuant to section 36-3303, paragraph 4 or the program receiving certification and approval by the secretary of the United States department of health and human services pursuant to section 36-3303, paragraph 2. As part of the implementation process, the department, in accordance with state procurement and contract laws, rules and procedures, shall: 1. Become licensed as a wholesaler or enter into a contract with a state-licensed wholesaler. 2. Contract with one or more state-licensed distributors. 3. Contract with one or more licensed and regulated Canadian suppliers. 4. Engage with health insurance plans, employers, pharmacies, health care providers and consumers. 5. Develop a registration process for health insurance plans, pharmacies and prescription drug-administering health care providers that are willing to participate in the program. 6. Create a publicly available source for listing the prices of imported prescription drug products that is available to all participating entities and consumers. 7. Establish an outreach and marketing plan to generate program awareness. 8. Establish and staff a hotline to answer questions and address the needs of consumers, employers, health insurance plans and pharmacies. 9. Establish the audit function and a two-year audit work-plan cycle. 10. Conduct any other activities that the department determines to be important to successfully implement the program. END_STATUTE START_STATUTE36-3305. Annual report The department shall annually report to the governor, the president of the senate and the speaker of the house of representatives and provide a copy of the report to the secretary of state regarding the operation of the wholesale prescription drug importation program during the previous calendar year. The report shall include information regarding all of the following: 1. Which prescription drugs were included in the program. 2. The number of participating pharmacies, health care providers and health insurance plans. 3. The number of prescriptions dispensed through the program. 4. The estimated savings to consumers, health plans, employers and this state during the previous calendar year and to date. 5. The implementation of the audit plan and audit findings. 6. Any other information the department deems relevant. END_STATUTE Sec. 2. Short title This act may be known as the "Safe, Low-cost Prescription Drugs Program Act".
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80	80	Be it enacted by the Legislature of the State of Arizona:
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82	82	Section 1. Title 36, Arizona Revised Statutes, is amended by adding chapter 33, to read:
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84	84	CHAPTER 33
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86	86	WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM
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88	88	ARTICLE 1. GENERAL PROVISIONS
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90	90	START_STATUTE36-3301. Definitions
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92	92	In this article, unless the context otherwise requires:
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94	94	1. "Department" means the department of health services.
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96	96	2. "Program" means the wholesale prescription drug importation program.
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98	98	3. "340B covered entity" and "340B drug pricing program" have the same meanings prescribed in section 36-2930.03.END_STATUTE
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100	100	START_STATUTE36-3302. Importation of prescription drugs; program design; funding design; submittal
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102	102	A. The department, in consultation with interested stakeholders and appropriate federal officials, shall design a wholesale prescription drug importation program that complies with the applicable requirements of 21 United States code section 384, including the requirements regarding safety and cost savings. The program design shall:
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104	104	1. Require the department to either become a licensed drug wholesaler or contract with a licensed drug wholesaler in order to seek federal certification and approval to import safe prescription drugs and provide significant prescription drug cost savings to consumers.
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106	106	2. Use Canadian prescription drug suppliers that are regulated under the laws of Canada or one or more Canadian provinces, or both.
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108	108	3. Ensure that only prescription drugs meeting the United States food and drug administration's safety, effectiveness and other standards are imported by or on behalf of this state.
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110	110	4. Import only those prescription drugs that are expected to generate substantial savings for consumers in this state.
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112	112	5. Ensure that the program complies with the tracking and tracing requirements of 21 United States Code sections 360eee and 360eee-1 to the extent feasible and practicable before imported drugs come into the possession of this state's wholesaler and that the program fully complies with these requirements after imported drugs are in the possession of this state's wholesaler.
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114	114	6. Prohibit the distribution, dispensing or sale of imported drugs outside of this state.
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116	116	7. Recommend a charge per prescription or another method of support to ensure that the program is adequately funded in a manner that does not jeopardize significant consumer savings.
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118	118	8. Include a robust audit protocol.
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120	120	B. The department shall recommend a funding design for the program and submit the funding design and the program design to the governor, the president of the senate and the speaker of the house of representatives. END_STATUTE
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122	122	START_STATUTE36-3303. Attorney general consultation; certification request; federal approval; limit on implementation
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124	124	The department shall:
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126	126	1. Consult with the attorney general's office to identify the potential for and to monitor anticompetitive behavior in industries that would be affected by a wholesale prescription drug importation program in this state.
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128	128	2. Submit a formal request to the secretary of the United States department of health and human services for certification of this state's wholesale prescription drug importation program.
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130	130	3. Seek the appropriate federal approvals, waivers, exemptions or agreements as needed to enable 340B covered entities that are enrolled in or eligible for the federal 340B drug pricing program to participate in this state's wholesale prescription drug importation program to the fullest extent possible without jeopardizing their eligibility for the 340B drug pricing program.
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132	132	4. Not implement the wholesale prescription drug importation program until the legislature enacts legislation that establishes either a charge per prescription or another source of program funding. END_STATUTE
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134	134	START_STATUTE36-3304. Program implementation
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136	136	The department shall begin implementing and operating the program within six months after the later of either the legislature enacting a method of program funding pursuant to section 36-3303, paragraph 4 or the program receiving certification and approval by the secretary of the United States department of health and human services pursuant to section 36-3303, paragraph 2. As part of the implementation process, the department, in accordance with state procurement and contract laws, rules and procedures, shall:
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138	138	1. Become licensed as a wholesaler or enter into a contract with a state-licensed wholesaler.
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140	140	2. Contract with one or more state-licensed distributors.
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142	142	3. Contract with one or more licensed and regulated Canadian suppliers.
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144	144	4. Engage with health insurance plans, employers, pharmacies, health care providers and consumers.
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146	146	5. Develop a registration process for health insurance plans, pharmacies and prescription drug-administering health care providers that are willing to participate in the program.
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148	148	6. Create a publicly available source for listing the prices of imported prescription drug products that is available to all participating entities and consumers.
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150	150	7. Establish an outreach and marketing plan to generate program awareness.
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152	152	8. Establish and staff a hotline to answer questions and address the needs of consumers, employers, health insurance plans and pharmacies.
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154	154	9. Establish the audit function and a two-year audit work-plan cycle.
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156	156	10. Conduct any other activities that the department determines to be important to successfully implement the program. END_STATUTE
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158	158	START_STATUTE36-3305. Annual report
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160	160	The department shall annually report to the governor, the president of the senate and the speaker of the house of representatives and provide a copy of the report to the secretary of state regarding the operation of the wholesale prescription drug importation program during the previous calendar year. The report shall include information regarding all of the following:
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162	162	1. Which prescription drugs were included in the program.
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164	164	2. The number of participating pharmacies, health care providers and health insurance plans.
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166	166	3. The number of prescriptions dispensed through the program.
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168	168	4. The estimated savings to consumers, health plans, employers and this state during the previous calendar year and to date.
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170	170	5. The implementation of the audit plan and audit findings.
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172	172	6. Any other information the department deems relevant. END_STATUTE
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174	174	Sec. 2. Short title
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176	176	This act may be known as the "Safe, Low-cost Prescription Drugs Program Act".