HOUSE OF REPRESENTATIVES
THIRTIETH LEGISLATURE, 2020
STATE OF HAWAII
A BILL FOR AN ACT
relating to prescription drugs.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:
SECTION 1. The Hawaii Revised Statutes is amended by adding a new chapter to be appropriately designated and to read as follows:
wholesale importation of prescription drugs
§ -1 Wholesale prescription drug importation program; established. The department of health shall administer in consultation with relevant state stakeholders and federal offices and agencies a wholesale prescription drug importation program that will meet the requirements of 21 U.S.C. section 384, including requirements regarding safety and cost savings. In developing a wholesale prescription drug importation program for federal certification, the department of health shall ensure that:
(1) The department of health either becomes a licensed wholesaler or licenses an entity to become a wholesaler for the purpose of seeking federal certification and approval to import safe prescription drugs that will provide savings to consumers;
(2) The program uses Canadian suppliers who are regulated under the appropriate Canadian laws;
(3) The program has a process in place to sample the purity, chemical composition, and potency of imported prescription drugs;
(4) The program only imports those prescription drugs that are expected to generate substantial savings for consumers;
(5) Imported prescription drugs shall not be distributed, dispensed, or sold outside of the borders of this State;
(6) Pharmacies and health care providers charge individual consumers and health plans not more than the actual acquisition cost of the imported, dispensed prescription drug;
(7) Health plan payments of the prescription drug component of pharmacy and health care provider billing reimburses not more than the actual acquisition cost of the dispensed, imported prescription drug;
(8) Participating health plans keep their formularies and claims payment systems up to date with the prescription drugs that are provided through the wholesale prescription drug importation program;
(9) Participating health plans base patient cost-sharing upon not more than the actual acquisition cost of the dispensed, imported prescription drug;
(10) Participating health plans demonstrate to the satisfaction of the director of health how savings on imported prescription drugs are reflected in premiums;
(11) The profit margin of any participating wholesaler or distributor of imported prescription drugs is limited to a specified amount to be established by the department of health;
(12) The program does not import generic prescription drugs that would violate federal patent laws for federally-branded prescription drugs;
(13) The program complies with the requirements of 21 U.S.C. sections 360eee and 360eee-1, pertaining to the track and trace requirements as enacted in Title II of the Drug Security and Quality Act (Public Law 113-54) to the extent practical and feasible before imported prescription drugs come into possession of the State wholesaler, and complies fully after imported prescription drugs are in the possession of the State wholesaler;
(14) The program is adequately financed through a fee on each prescription or other appropriate approach, but the size of the fee shall not jeopardize significant consumer savings; and
(15) The program includes an audit function to ensure that:
(A) The department of health has a sound methodology by which to determine the most cost-effective prescription drugs to include on an ongoing basis in the prescription drug importation program;
(B) The department of health has processes in place to select Canadian suppliers of high quality and performance, and that are in full compliance with Canadian law and regulation;
(C) Imported prescription drugs under the state program are not shipped, sold, or dispensed outside the State once in the possession of the State;
(D) Imported prescription drugs are pure, unadulterated, potent, and safe;
(E) Participating pharmacies and administering providers are not charging more than the actual acquisition cost to any consumer or any participating health plan;
(F) Participating health plan formularies and claims processing systems remain up to date with all relevant aspects of the prescription drug importation program;
(G) Participating health plans base patient coinsurance and other cost sharing upon the actual acquisition cost of covered, imported prescription drugs;
(H) Participating health plans reimburse participating pharmacies and administering providers actual acquisition cost for imported, dispensed prescription drugs;
(I) The program is adequately financed to support all administrative functions while generating significant consumer savings;
(J) The program does not put consumers at higher risk than if the program did not exist; and
(K) The program continues to provide consumers in the State with substantial savings on prescription drugs.
§ -2 Monitoring for anti-competitive behavior. The department of health shall coordinate with the attorney general to identify the potential for anti-competitive behavior in industries that would be affected by a program of prescription drug importation.
§ -3 Submission of request for federal certification and approval. The department of health shall submit a formal request to the Secretary of the United States Department of Health and Human Services for certification of the State's wholesale prescription drug importation program.
§ -4 Implementation and additional administrative requirements. Upon certification and approval by the Secretary of the United States Department of Health and Human Services, the department of health shall begin implementation of the wholesale prescription drug importation program and have the program operational within six months of the date of the Secretary's certification. As part of the implementation process, the department of health shall:
(1) Become licensed as a wholesaler or license an entity to become a wholesaler;
(2) Contract with a state-licensed distributor or distributors;
(3) Contract with a licensed or regulated Canadian supplier or suppliers;
(4) Engage health plans, employers, pharmacies, providers, and consumers;
(5) Develop a registration process in which health plans, pharmacies, and administering providers are willing to participate;
(6) Create a publicly available source for listing prices of imported prescription drugs that will be available to all participating entities and consumers;
(7) Create an outreach and marketing plan to generate program awareness;
(8) Create and staff a hotline to answer questions from any affected sector starting in the weeks before the program becomes operational, which can address the needs and questions of consumers, employers, plans, pharmacies, and providers;
(9) Establish an audit function and a two-year audit work plan cycle; and
(10) Conduct any other activities determined to be important to successful implementation as determined by the department of health.
§ -5 Report to the governor and the legislature. The department of health shall provide an annual report to the governor and the legislature, that includes:
(1) The prescription drugs covered in the wholesale prescription drug importation program;
(2) The number of participating pharmacies, providers, and health plans;
(3) The number of prescriptions dispensed under the program in the reporting period;
(4) The estimated savings to consumers, health plans, and employers that resulted from the program in the reporting period;
(5) In the first three reporting periods, information on the implementation of the audit plan and audit findings for the reporting period; and
(6) Any other information as determined by the department of health."
SECTION 2. This Act shall take effect upon its approval.
DOH; Prescription Drugs; Importation
Authorizes the Department of Health to implement a program for wholesale drug importation.
The summary description of legislation appearing on this page is for informational purposes only and is not legislation or evidence of legislative intent.