SECTION 1. (a) For the purposes of this section:
1)“wholesale importation program” shall mean a state-administered wholesale importation program where the state is the licensed wholesaler, importing drugs from a licensed, regulated Canadian supplier, solely for distribution to voluntarily participating, state-licensed, in-state pharmacies and administering providers for the exclusive purpose of dispensing state residents with a valid prescription
2)“department” shall mean the executive office of health and human services
(b) Notwithstanding any general or special law to the contrary, the executive office of health and human services, 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 U.S.C. 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 the commonwealth’s consumers;
2)use Canadian prescription drug suppliers regulated under laws of Canada or of one or more Canadian provinces, or both;
3)include a process to sample the purity, chemical composition, and potency of the imported products;
4)import only those prescription drugs expected to generate substantial savings for the commonwealth’s consumers;
5)ensure that only prescription drugs meeting the U.S. Food and Drug Administration’s safety, effectiveness, and other standards shall be imported by or on behalf of the commonwealth;
6)ensure that the program complies with the tracking and tracing requirements of 21 U.S.C. 360eee and 360eee-1 to the extent feasible and practical prior to imported drugs coming into the possession of the state wholesaler and that it complies fully after imported drugs are in the possession of the state wholesaler;
7)prohibit the distribution, dispensing, or sale of imported products outside the commonwealth’s borders;
8)ensure the voluntary participant, state-licensed pharmacies and administering providers charge individual consumers and health plans the actual acquisition cost of the imported, dispensed product;
9)ensure health plan payment of the product component of pharmacy and provider billing reimburses no more than the actual acquisition cost of the dispensed, imported product;
10)ensure participating health plans keep their formularies and claims payment systems up to date with the prescription drugs provided through the wholesale importation program;
11)ensure participating health plans base patient cost sharing on no more than the actual acquisition cost of the dispensed, imported product;
12)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;
13)require participating health plans to demonstrate to the department how savings on imported drugs are reflected in premiums;
14)enlist the assistance of the attorney general to identify the potential for anticompetitive behavior in industries that would be affected by a program of importation;
15)limit the profit margin of any participating wholesaler and/or distributor(s) of imported pharmaceutical products to a specified amount established by the department; and
16)ensure the program does not import generic products that would violate the U.S. patent laws on U.S. branded products.
(c) The department shall enlist the assistance of the attorney general to identify the potential for anticompetitive behavior in industries that would be affected by a program of importation.
(d) The department shall submit the proposed design for a wholesale prescription drug importation program to the house and senate committees on ways and means, the joint committee on health care financing, and the clerks of the house of representatives and the senate within [six months from the passage of this act].
(e) Upon approval of the importation program from the general court, the department shall submit a formal request to the Secretary of the U.S. Department of Health and Human Services for certification of the commonwealth’s wholesale prescription drug importation program. The department shall 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 commonwealth’s wholesale prescription drug importation program to the fullest extent possible without jeopardizing their eligibility for said drug pricing program.
(f) The department shall not implement the wholesale prescription drug importation program until the general court enacts legislation establishing a charge per prescription or another method of financial support for the program.
(g) Upon the last to occur of the general court enacting a method of financial support pursuant to subsection (f) of this section and receipt of certification and approval by the U.S. Department of Health and Human Services, the department shall begin implementation of the wholesale prescription drug importation program and shall begin operating the program within six months. As part of the implementation process, the department shall, in accordance with state procurement and contracting and rules 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, health care providers, and consumers;
5)develop a registration process for health insurance plans, pharmacies, and prescription drug-administering health care 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 shall be made available to all participating entities and consumers;
7)create an outreach and marketing plan to generate program awareness;
8)starting in the weeks before the program becomes operational, create and staff a hotline to answer questions and address the needs of consumers, employers, health insurance plans, pharmacies, health care providers, and other affected sectors;
9)establish the audit function and a two-year audit work-plan cycle; and
10)conduct any other activities that the department determines to be important for successful implementation of the program.
(h) Biannually, commencing with either the first June or December after implementation, whichever is the nearest date to the date that is six months following program implementation, the department shall report to the house and senate committees on ways and means, the joint committee on health care financing, and the clerks of the house of representatives and the senate regarding the operation of the wholesale prescription drug importation program, including:
1)which prescription drugs were included in the wholesale importation 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 the commonwealth during the previous calendar year and to date;
5)information regarding implementation of the audit plan and audit findings; and
6)any other information the department deems relevant.
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