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REFERENCE TITLE: prescription drugs; importation program |
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State of Arizona Senate Fifty-fourth Legislature Second Regular Session 2020
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SB 1600 |
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Introduced by Senators Rios: Alston, Bradley, Contreras, Dalessandro, Gonzales, Mendez, Navarrete, Otondo, Peshlakai, Quezada, Steele
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AN ACT
Amending title 36, Arizona Revised Statutes, by adding chapter 16; relating to prescription drugs.
(TEXT OF BILL BEGINS ON NEXT PAGE)
Be it enacted by the Legislature of the State of Arizona:
Section 1. Title 36, Arizona Revised Statutes, is amended by adding chapter 16, to read:
CHAPTER 16
WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM
ARTICLE 1. GENERAL PROVISIONS
36-1801. 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.
36-1802. Importation of prescription drugs; program 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. Designate a state agency that shall 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 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 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 funded adequately 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.
36-1803. 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.
36-1804. 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 36‑1803, paragraph 4 or receiving certification and approval by the secretary of the United States department of health and human services pursuant to section 36-1803, 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.
36-1805. 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. Information regarding implementation of the audit plan and audit findings.
6. Any other information the department deems relevant.
36-1806. Program termination
The program established by this chapter ends on July 1, 2030 pursuant to section 41‑3102.
Sec. 2. Short title
This act may be known as the "Safe, Low‑cost Prescription Drugs Program Act".