Amends TCA Title 4; Title 53; Title 68 and Title 71.
This bill requires the department of health, in consultation with interested stakeholders and appropriate federal officials, to design a wholesale prescription drug importation program that complies with the applicable requirements of federal law, including the requirements regarding safety and cost savings. The program design must: (1) Designate a state agency 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 Tennessee consumers; (2) Use Canadian prescription drug suppliers regulated under the laws of Canada or of 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 Tennessee consumers; (5) Ensure that the program complies with the tracking and tracing requirements of federal law to the extent feasible and practical prior to imported drugs coming into the possession of the state wholesaler and that the state wholesaler complies fully after imported drugs are in the possession of the state wholesaler; (6) Prohibit the distribution, dispensing, or sale of imported products outside the borders 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; and (8) Include a robust audit function. This bill requires the commissioner of health to submit, on or before January 1, 2022, the proposed design for a wholesale prescription drug importation program to the health committee of the house, the health and welfare committee of the senate, and the finance, ways and means committees of the house and the senate. This bill further requires the following: (1) The department to consult with the attorney general to identify the potential, and to monitor for anticompetitive behavior in industries that would be affected by a wholesale prescription drug importation program; (2) The commissioner to submit, on or before July 1, 2022, 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; and (3) The department to seek the appropriate federal approvals, waivers, exemptions, or agreements, or a combination thereof, as needed to enable all covered entities enrolled in or eligible for the federal 340B drug pricing program to participate in the state wholesale prescription drug importation program to the fullest extent possible without jeopardizing their eligibility for the 340B program. This bill prohibits the department from implementing the wholesale prescription drug importation program until: (1) The general assembly enacts legislation establishing a charge per prescription or another method of financial support for the program; or (2) Another source of program funding is in place. Upon the last to occur of the general assembly enacting a method of financial support pursuant to the above provisions and receipt of certification and approval by the secretary of the United States department of health and human services, the department will begin implementation of the wholesale prescription drug importation program and will begin operating the program within six months. As part of the implementation process, the department will, in accordance with state procurement and contract laws, rules, and procedures, as appropriate: (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, healthcare providers, and consumers; (5) Develop a registration process for health insurance plans, pharmacies, and prescription drug-administering healthcare providers who are willing to participate in the program; (6) Create a publicly available source for listing the prices of imported prescription drug products that must be made available to all participating entities and consumers; (7) Create an outreach and marketing plan to generate program awareness; (8) No less than 30 days before the program becomes operational, create and staff a hotline to answer questions and address the needs of consumers, employers, health insurance plans, and pharmacists; (9) Establish the audit function and a two-year audit work-plan cycle; and (10) Conduct other activities that the department determines to be important for successful implementation of the program. This bill requires the department to annually deliver a report to the health committee of the house, the health and welfare committee of the senate, the finance, ways and means committees of the house and the senate, and the legislative librarian regarding the operation of the wholesale prescription drug importation program during the previous calendar year, including: (1) Which prescription drugs were included in the wholesale importation program; (2) The number of participating pharmacies, healthcare providers, and health insurance plans; (3) The number of prescriptions dispensed through the program; (4) The estimated savings to consumers, health insurance plans, employers, and this state during the previous calendar year and to date; (5) Information regarding implementation of the audit plan and audit findings; and (6) Other information the department deems relevant.
This bill requires the department of health, in consultation with interested stakeholders and appropriate federal officials, to design a wholesale prescription drug importation program that complies with the applicable requirements of federal law, including the requirements regarding safety and cost savings. The program design must: (1) Designate a state agency 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 Tennessee consumers; (2) Use Canadian prescription drug suppliers regulated under the laws of Canada or of 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 Tennessee consumers; (5) Ensure that the program complies with the tracking and tracing requirements of federal law to the extent feasible and practical prior to imported drugs coming into the possession of the state wholesaler and that the state wholesaler complies fully after imported drugs are in the possession of the state wholesaler; (6) Prohibit the distribution, dispensing, or sale of imported products outside the borders 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; and (8) Include a robust audit function. This bill requires the commissioner of health to submit, on or before January 1, 2022, the proposed design for a wholesale prescription drug importation program to the health committee of the house, the health and welfare committee of the senate, and the finance, ways and means committees of the house and the senate. This bill further requires the following: (1) The department to consult with the attorney general to identify the potential, and to monitor for anticompetitive behavior in industries that would be affected by a wholesale prescription drug importation program; (2) The commissioner to submit, on or before July 1, 2022, 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; and (3) The department to seek the appropriate federal approvals, waivers, exemptions, or agreements, or a combination thereof, as needed to enable all covered entities enrolled in or eligible for the federal 340B drug pricing program to participate in the state wholesale prescription drug importation program to the fullest extent possible without jeopardizing their eligibility for the 340B program. This bill prohibits the department from implementing the wholesale prescription drug importation program until: (1) The general assembly enacts legislation establishing a charge per prescription or another method of financial support for the program; or (2) Another source of program funding is in place. Upon the last to occur of the general assembly enacting a method of financial support pursuant to the above provisions and receipt of certification and approval by the secretary of the United States department of health and human services, the department will begin implementation of the wholesale prescription drug importation program and will begin operating the program within six months. As part of the implementation process, the department will, in accordance with state procurement and contract laws, rules, and procedures, as appropriate: (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, healthcare providers, and consumers; (5) Develop a registration process for health insurance plans, pharmacies, and prescription drug-administering healthcare providers who are willing to participate in the program; (6) Create a publicly available source for listing the prices of imported prescription drug products that must be made available to all participating entities and consumers; (7) Create an outreach and marketing plan to generate program awareness; (8) No less than 30 days before the program becomes operational, create and staff a hotline to answer questions and address the needs of consumers, employers, health insurance plans, and pharmacists; (9) Establish the audit function and a two-year audit work-plan cycle; and (10) Conduct other activities that the department determines to be important for successful implementation of the program. This bill requires the department to annually deliver a report to the health committee of the house, the health and welfare committee of the senate, the finance, ways and means committees of the house and the senate, and the legislative librarian regarding the operation of the wholesale prescription drug importation program during the previous calendar year, including: (1) Which prescription drugs were included in the wholesale importation program; (2) The number of participating pharmacies, healthcare providers, and health insurance plans; (3) The number of prescriptions dispensed through the program; (4) The estimated savings to consumers, health insurance plans, employers, and this state during the previous calendar year and to date; (5) Information regarding implementation of the audit plan and audit findings; and (6) Other information the department deems relevant.
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