TITLE X
PUBLIC HEALTH

Chapter 126-CC
WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM

Section 126-CC:1

    126-CC:1 Definitions. –
In this chapter:
I. "Commissioner" means the commissioner of the department of health and human services.
II. "Department" means the department of health and human services.
III. "Program" means the wholesale prescription drug importation program.

Source. 2020, 13:6, eff. Sept. 14, 2020.

Section 126-CC:2

    126-CC:2 Design of Program: Rulemaking. –
I. There is hereby established the wholesale prescription drug importation program, referred to in this chapter as the "program," to provide for the wholesale importation of prescription drugs from Canada by or on behalf of the state.
II. The department, in consultation with appropriate federal and other state agencies and interested parties, shall design the program to comply with the applicable requirements of 21 U.S.C. section 384, including requirements regarding safety and cost savings. The program design shall:
(a) Designate a state agency to become a licensed drug wholesaler or to contract with a licensed drug wholesaler in order to seek federal certification and approval, pursuant to RSA 126-CC:3, to import safe prescription drugs and provide cost savings to consumers in the state.
(b) Use prescription drug suppliers in Canada regulated under the laws of Canada or of one or more Canadian provinces, or both.
(c) Ensure that only prescription drugs that can meet the federal Food and Drug Administration's safety, effectiveness and other standards are imported by or on behalf of the state.
(d) Import only those prescription drugs expected to generate substantial cost savings for consumers in the state.
(e) Ensure that the program complies with the transaction and tracing requirements of 21 U.S.C. sections 360eee and 360eee-1 to the extent feasible and practical prior to imported prescription drugs coming into the possession of the licensed United States drug wholesaler and that the program complies fully with those federal requirements after imported prescription drugs are in the possession of the licensed drug wholesaler.
(f) Prohibit the distribution, dispensing, or sale of imported prescription drugs outside of the state.
(g) Recommend a method to finance the program which will not jeopardize consumer cost savings.
(h) Include an audit function.
III. The commissioner shall adopt rules pursuant to RSA 541-A, to design the program in accordance with this chapter.
IV. The department shall submit a request for approval and certification of the program to the United States Department of Health and Human Services on or before February 1, 2021.

Source. 2020, 13:6, eff. Sept. 14, 2020.

Section 126-CC:3

    126-CC:3 Requirements of Program. –
Prior to operating the program, the state agency designated to oversee the program pursuant to this chapter shall:
I. Become a licensed drug wholesaler or enter into a contract with a licensed drug wholesaler in the state.
II. Contract with one or more distributors licensed in the state.
III. Contract with one or more licensed and regulated prescription drug suppliers in Canada.
IV. Seek the appropriate federal approvals, 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 program to the fullest extent possible without jeopardizing their eligibility for the 340B Program.
V. Consult with health insurance carriers, employers, pharmacies, pharmacists, health care providers, and consumers.
VI. Develop a registration process for health insurance carriers, pharmacies, and health care providers authorized to prescribe and administer prescription drugs that are willing to participate in the program.
VII. Create a publicly accessible website for listing the prices of prescription drugs to be imported under the program.
VIII. Create an outreach and marketing plan to work with health carriers and provider associations to generate public awareness of the program.
IX. Develop a 2-year audit work plan.
X. Conduct any other activity determined necessary to successfully implement and operate the program.

Source. 2020, 13:6, eff. Sept. 14, 2020.

Section 126-CC:4

    126-CC:4 Annual Report. –
Beginning November 1, 2021, and each November 1 thereafter, the department or other designated state agency shall submit an annual report to the chairperson of the health, human services and elderly affairs committee, the speaker of the house of representatives, the president of the senate, the house clerk, the senate clerk, the governor, and the state library relative to:
I. The prescription drugs included in the program.
II. The number of participating pharmacies, health care providers, and health insurance carriers.
III. The number of prescription drugs dispensed through the program.
IV. The estimated cost savings to consumers, health insurance carriers, employers, and the state during the previous calendar year and to date.
V. Information regarding implementation of the audit work plan and audit findings.
VI. Any other information the department, or other state agency designated to oversee the program pursuant to this chapter, deems relevant.

Source. 2020, 13:6, eff. Sept. 14, 2020.