Rep. Norm Thurston — Voting Record

Bill

Number

H.B. 267 (2019GS)

Sponsor

Rep. Thurston, N.  (Thurston’s own bill)

Final action

House/ filed 3/14/2019

Outcome

Failed / filed without passage

Summary

What it does

• This bill:
• defines terms;
• requires the Department of Health to:
• design a prescription drug importation program;
• apply for approval of the prescription drug importation program;
• if the program is approved, implement the provisions of the program; and
• if approval is denied, study how the state can obtain approval for the program;
• describes the requirements of the prescription drug importation program;
• modifies the Utah Antitrust Act to make certain anticompetitive activities illegal; and
• creates a sunset date for the provisions of this bill.

Every vote on this bill

Bill text

PRESCRIPTION DRUG IMPORTATION PROGRAM
GENERAL SESSION
STATE OF UTAH
Chief Sponsor: Norman K. Thurston
Senate Sponsor: 
 Curtis S. Bramble
LONG TITLE
General Description:
This bill creates a program and reporting requirements relating to prescription drugs
and the importation of prescription drugs.
Highlighted Provisions:
This bill:
▸ defines terms;
▸ requires the Department of Health to:
• design a prescription drug importation program;
• apply for approval of the prescription drug importation program;
• if the program is approved, implement the provisions of the program; and
• if approval is denied, study how the state can obtain approval for the program;
▸ describes the requirements of the prescription drug importation program;
▸ modifies the Utah Antitrust Act to make certain anticompetitive activities illegal;
and
▸ creates a sunset date for the provisions of this bill.
Money Appropriated in this Bill:
None
Other Special Clauses:
None
Utah Code Sections Affected:
AMENDS:
63I-1-226
, as last amended by Laws of Utah 2018, Chapters 180, 281, 384, 430, and
468
63I-1-276
, as enacted by Laws of Utah 2014, Chapter 226
76-10-3104
, as renumbered and amended by Laws of Utah 2013, Chapter 187
ENACTS:
26-66-101
, Utah Code Annotated 1953
26-66-102
, Utah Code Annotated 1953
26-66-201
, Utah Code Annotated 1953
26-66-202
, Utah Code Annotated 1953
26-66-301
, Utah Code Annotated 1953
26-66-302
, Utah Code Annotated 1953
26-66-303
, Utah Code Annotated 1953
26-66-304
, Utah Code Annotated 1953
26-66-305
, Utah Code Annotated 1953
26-66-401
, Utah Code Annotated 1953
Be it enacted by the Legislature of the state of Utah:
Section 1. Section 
26-66-101
 is enacted to read:
CHAPTER 66. PRESCRIPTION DRUG AFFORDABILITY ACT
Part 1. General Provisions
 26-66-101.
Title.
This chapter is known as the "Prescription Drug Affordability Act."
Section 2. Section 
26-66-102
 is enacted to read:
 26-66-102.
Definitions.
As used in this chapter:
(1) "Drug" means the same as that term is defined in Section 
58-17b-102
.
(2) "Health insurer" means:
(a) an insurer who offers health care insurance as that term is defined in Section
31A-1-301
;
(b) for health benefits offered to state employees under Section 
49-20-202
, the Public
Employees' Benefit and Insurance Program created in Section 
49-20-103
; or
(c) a workers' compensation insurer:
(i) authorized to provide workers' compensation insurance in the state; or
(ii) that is a self-insured employer as defined in Section 
34A-2-201.5
.
(3) "Pharmaceutical manufacturer" means:
(a) a person that is engaged in the manufacturing of drugs or pharmaceutical devices
that are available for purchase by residents of the state; or
(b) a person that is responsible for setting the price of a drug or device that is available
for purchase by residents of the state on behalf of a person described in this Subsection (3).
(4) "Prescription drug importation program" means the Canadian Prescription Drug
Importation Program established under Section 
26-66-301
.
(5) "Secretary" means the secretary of the United States Department of Health and
Human Services.
Section 3. Section 
26-66-201
 is enacted to read:
Part 2. Application and Certification
 26-66-201.
Application for approval of prescription drug importation program
and certification of Canadian drug importation.
(1) The department shall submit to the secretary:
(a) no later than July 31, 2019, a brief letter of intent to seek approval for a program to
allow for the importation of prescription drugs from Canada into the state under the provisions
of 21 U.S.C. Sec. 384(l); and
(b) no later than December 31, 2019, an application for:
(i) the approval of a program to allow for the importation of prescription drugs from
Canada into the state under the provisions of 21 U.S.C. Sec. 384(l); and
(ii) certification by the secretary to the United States Congress, in accordance with 21
U.S.C. Sec. 384(l), that importation of Canadian prescription drugs will:
(A) pose no additional risk to the public's health and safety; and
(B) result in a significant reduction in the cost of covered products to the American
consumer.
(2) The application described in Subsection (1)(b) shall contain:
(a) the findings of the prescription drug importation study described in Section
26-66-202
;
(b) a description of the prescription drug importation program designed by the
department in accordance with the provisions of this chapter, including measures that will be
taken to:
(i) comply with existing state and federal law; and
(ii) reduce the risk to the public's health and safety; and
(c) an estimate of the reduction in the cost of covered products and health insurance
premiums to Utah consumers.
(3) If the department does not believe that the department will be able to submit the
application described in Subsection (1)(b) before December 31, 2019, the department shall
report to the Health and Human Services Interim Committee before December 31, 2019, on:
(a) the reason for the delay in submitting the application;
(b) any steps that the department has taken to prepare the application; and
(c) when the department believes that the application will be ready for submission.
(4) If the application for the prescription drug importation program is not approved by
the secretary, the department shall submit a new application in accordance with the
requirements in Subsection (2) on or before December 1 of each year until the earlier of:
(a) approval of the prescription drug importation program by the secretary; or
(b) January 1, 2024.
(5) On or before December 1 of each year that the department submits an application
under Subsection (2) or (4), the department shall submit a written report to the Health and
Human Services Interim Committee regarding the results of the application and any updated
findings and recommendations.
Section 4. Section 
26-66-202
 is enacted to read:
 26-66-202.
Prescription drug importation study.
(1) As funding is available, the department shall study how to gain approval by the
secretary for the state to import certain prescription drugs from Canada for eventual use by
Utah consumers.
 (2) The study described in Subsection (1) shall include:
 (a) a plan for operating the prescription drug importation program;
 (b) a plan to ensure that prescription drugs imported into the state under the
prescription drug importation program meet applicable United States federal and state
standards for safety and effectiveness;
 (c) examples of prescription drugs with the highest potential for consumer savings
through importation at the time of the study;
 (d) an estimate of the total potential consumer savings attributable to importation of
prescription drugs;
 (e) a list of potential wholesalers with whom the state could contract to distribute
imported prescription drugs;
 (f) proposed amendments to state law to facilitate importation by the state; and
 (g) in coordination with the Office of the Attorney General, proposed amendments to
state law to inhibit pharmaceutical manufacturers from manipulating the pharmaceutical
market in the state or adversely affecting consumer access to pharmaceuticals under the
prescription drug importation program.
 (3) The department shall consult with the Utah State Board of Pharmacy,
representatives of the pharmaceutical industry, patient advocates, health insurers, and others
representing persons who could be affected by the prescription drug importation program in
conducting the study in this section.
 (4) No later than November 1, 2019, the department shall submit a written report to the
Health and Human Services Interim Committee on the findings and recommendations of the
study described in this section.
(5) The department shall seek grant funding to conduct the study described in this
section.
Section 5. Section 
26-66-301
 is enacted to read:
Part 3. Canadian Prescription Drug Importation Program
 26-66-301.
Canadian Prescription Drug Importation Program.
The department shall establish a Canadian Prescription Drug Importation Program in
accordance with the provisions in this chapter.
Section 6. Section 
26-66-302
 is enacted to read:
 26-66-302.
Program requirements.
The prescription drug importation program established under Section 
26-66-301
 shall:
 (1) only allow for the importation of prescription drugs that have been identified by the
department in the pharmaceutical importation list described in Section 
26-66-303
;
 (2) monitor consumer prices to ensure that market competition and routine health plan
administration provide significant savings for Utah consumers;
 (3) specify the actions that the department, the Insurance Department, and the
Department of Commerce will take if market competition and routine health plan
administration does not result in significant savings for Utah consumers;
 (4) only use Canadian suppliers regulated under relevant Canadian federal or provincial
laws;
 (5) if required by the secretary, establish a process to ensure the purity, chemical
composition, and potency of imported products;
 (6) ensure that imported prescription drugs will not be distributed, dispensed, or sold
outside of the state;
 (7) ensure that the program does not import a generic prescription drug that would
violate United States patent laws;
 (8) comply with the track and trace requirements in Title II of the Drug Security and
Quality Act, 4 U.S.C. Sec. 360eee, et seq., before imported prescription drugs come into
possession of the wholesaler;
 (9) ensure that the supply and distribution chain is in compliance with applicable
United States federal and state law after imported prescription drugs are in the possession of
the wholesaler;
 (10) ensure that the prescription drug importation program is adequately financed
through an efficient approach that does not jeopardize significant consumer savings;
 (11) require publication of a wholesaler's acquisition cost of each imported prescription
drug;
 (12) for an imported prescription drug, require a participating pharmacy to disclose
upon request the price of the drug that the participating pharmacy will charge to a patient who
is not covered by a health plan or contract;
 (13) include an audit function described in Section 
26-66-304
; and
(14) ensure that participation by a wholesaler, health insurer, health care provider, or
consumer is voluntary.
Section 7. Section 
26-66-303
 is enacted to read:
 26-66-303.
Pharmaceutical importation list.
(1) (a) The department shall coordinate with the Utah State Board of Pharmacy to
develop and periodically revise a pharmaceutical importation list in accordance with this
section.
 (b) The department may coordinate with a working group created under the direction of
the Utah State Board of Pharmacy to satisfy the requirement in Subsection (1)(a).
 (2) The pharmaceutical importation list described in Subsection (1)(a):
 (a) shall include prescription drugs that:
 (i) may be imported from Canada under applicable United States federal and state law;
and
 (ii) are expected to generate substantial savings for Utah consumers; and
 (b) may not include a prescription drug that may not be imported under applicable
United States federal and state law.
 (3) A participating health insurer shall provide the department and the Utah State
Board of Pharmacy or the designees of the Utah State Board of Pharmacy with any information
requested by the department regarding the net per unit cost of the health insurer's top 20
high-cost drugs and the quantity of those drugs dispensed by the health insurer to covered
individuals.
 (4) The information described in Subsection (3):
 (a) shall only be requested and used for the purpose of developing the pharmaceutical
importation list or enforcing provisions of this chapter;
 (b) is proprietary information that the department, the Utah State Board of Pharmacy,
or a designee of the Utah State Board of Pharmacy may not disclose to any person;
 (c) is a private record for the purpose of Title 63G, Chapter 2, Government Records
Access and Management Act; and
 (d) may not contain personally identifiable personal health care information that is
protected by the Health Insurance Portability and Accountability Act as defined in Section
31A-1-301
.
 (5) The department shall:
 (a) review the pharmaceutical importation list every three months to ensure that the
pharmaceutical importation list continues to meet the requirements in Subsection (2); and
 (b) establish policies and procedures by rule made in accordance with Title 63G,
Chapter 3, Utah Administrative Rulemaking Act, for updating the pharmaceutical importation
list in accordance with Subsection (5)(a).
Section 8. Section 
26-66-304
 is enacted to read:
 26-66-304.
Audits.
(1) The prescription drug importation program established under Section 
26-66-301
shall include audits of suppliers, importers, wholesalers, retail pharmacies, health insurers, and
other persons who participate in the prescription drug importation program as appropriate and
necessary.
 (2) The audit function in Subsection (1) shall:
 (a) include a review of the:
 (i) methodology used to determine the prescription drugs with the greatest potential for
savings;
 (ii) process used to ensure that Canadian suppliers are of high quality, high
performance, and in full compliance with Canadian laws;
 (iii) methods used to ensure that imported prescription drugs under the prescription
drug importation program are not shipped, sold, or dispensed outside the state once in the
possession of the wholesaler or the wholesaler's contractors; and
 (iv) processes used to ensure that imported prescription drugs are pure, unadulterated,
potent, and safe; and
 (b) ensure that Utah consumers benefit from significant savings by verifying that:
 (i) participating pharmacies and administering providers are not charging rates that
jeopardize significant consumer savings to any consumer or participating health plan;
 (ii) the prescription drug importation program is adequately financed to support all
administrative functions while generating significant consumer savings;
 (iii) the prescription drug importation program does not put consumers at a higher
health and safety risk than if the program did not exist;
 (iv) the prescription drug importation program continues to provide Utah consumers
with substantial savings on imported prescription drugs; and
 (v) a participating pharmacy's ability to negotiate professional fees is not impeded.
 (3) The department shall coordinate with the Insurance Department and the
Department of Commerce to conduct audits in accordance with this section and to enforce the
provisions of this chapter.
Section 9. Section 
26-66-305
 is enacted to read:
 26-66-305.
Implementation.
(1) The department is responsible for implementing the provisions of the prescription
drug importation program upon:
(a) certification by the secretary to the United States Congress, in accordance with 21
U.S.C. Sec. 384(l), that importation of Canadian prescription drugs will:
(i) pose no additional risk to the public's health and safety; and
(ii) result in a significant reduction in the cost of covered products to the American
consumer;
(b) approval by the secretary of the prescription drug importation program;
(c) satisfying any other requirements of state and federal law for the importation of
prescription drugs from Canada; and
(d) collecting fees under Subsection (3)(a) sufficient to cover the startup costs of the
prescription drug program.
(2) The department shall implement the prescription drug importation program by
contracting with any wholesale pharmacy that:
(a) is licensed to operate in the state as a class C pharmacy under Section 
58-17b-302
;
(b) complies with the program requirements described in Section 
26-66-302
; and
(c) agrees to any additional conditions of participation that may be established by the
department in accordance with the requirements of federal law and this chapter.
(3) (a) The department shall establish fees, in accordance with Section 
63J-1-504
, on
an entity that participates in the prescription drug importation program to cover all startup and
implementation costs of the prescription drug program.
(b) The Insurance Department may establish fees, in accordance with Section
63J-1-504
, on an insurer that participates in the prescription drug importation program to take
an action specified by the department under Subsection 
26-66-302
(3) or Subsection
26-66-304
(3).
(c) (i) A fee collected by the department under Subsection (3)(a) is a dedicated credit
for use by the department to implement this chapter.
(ii) A fee collected by the Insurance Department under Subsection (3)(b) is a dedicated
credit for use by the Insurance Department to perform the functions described in Subsection
(3)(b).
(d) The fees in Subsections (3)(a) and (b) may not exceed the amount necessary to
cover the cost the department incurs to implement this chapter.
(e) The department shall deposit into the General Fund the fees described in Subsection
(3)(a) as a dedicated credit to be used solely to pay for the cost of implementing this chapter.
(4) Before the conditions described in Subsection (1) are satisfied, the department:
(a) may, to the extent allowed under United State federal and state law:
(i) design the prescription drug importation program; and
(ii) negotiate with wholesalers in Canada and the United States regarding the potential
implementation of the prescription drug importation program; and
(b) may not:
(i) allow the importation of any prescription drugs under this chapter; or
(ii) implement any provisions of the prescription drug importation program that would
violate United States federal or state law.
Section 10. Section 
26-66-401
 is enacted to read:
 26-66-401.
Pharmaceutical manufacturer -- Prohibited conduct -- Penalties.
(1) A pharmaceutical manufacturer may not:
(a) take any action, by agreement, unilaterally, or otherwise, that has the effect of
fixing or otherwise controlling the price that a pharmaceutical supplier, distributor, or dispenser
charges or advertises for pharmaceuticals in the drug importation program; or
(b) discriminate against a pharmaceutical supplier, distributor, or dispenser based on
whether the supplier, distributor, or dispenser participates in the prescription drug importation
program.
(2) The attorney general may bring a civil action or seek an injunction against any
person who violates a provision of this section, and may seek any remedy available to the
attorney general for violations of Title 76, Chapter 10, Part 31, Utah Antitrust Act.
Section 11. Section 
63I-1-226
 is amended to read:
63I-1-226.
Repeal dates, Title 26.
(1) Section 
26-1-40
 is repealed July 1, 2019.
(2) Title 26, Chapter 9f, Utah Digital Health Service Commission Act, is repealed July
1, 2025.
(3) Section 
26-10-11
 is repealed July 1, 2020.
(4) Subsection 
26-18-417
(3) is repealed July 1, 2020.
(5) Title 26, Chapter 33a, Utah Health Data Authority Act, is repealed July 1, 2024.
(6) Title 26, Chapter 36b, Inpatient Hospital Assessment Act, is repealed July 1, 2024.
(7) Title 26, Chapter 36c, Medicaid Expansion Hospital Assessment Act, is repealed
July 1, 2024.
(8) Title 26, Chapter 36d, Hospital Provider Assessment Act, is repealed July 1, 2019.
(9) Title 26, Chapter 56, Hemp Extract Registration Act, is repealed January 1, 2019.
(10) Title 26, Chapter 63, Nurse Home Visiting Pay-for-Success Program, is repealed
July 1, 2026.
(11) Title 26, Chapter 66, Prescription Drug Affordability Act, is repealed July 1, 2029.
Section 12. Section 
63I-1-276
 is amended to read:
63I-1-276.
Repeal dates, Title 76.
(1)
 Subsection 
76-10-526
(15) is repealed July 1, 2018.
(2) Subsection 
76-10-3104
(3), referencing anticompetitive activities regarding
prescription drugs, is repealed July 1, 2029.
Section 13. Section 
76-10-3104
 is amended to read:
76-10-3104.
Illegal anticompetitive activities.
(1) Every contract, combination in the form of trust or otherwise, or conspiracy in
restraint of trade or commerce is declared to be illegal.
(2) It shall be unlawful for any person to monopolize, or attempt to monopolize, or
combine or conspire with any other person or persons to monopolize, any part of trade or
commerce.
(3) For purposes of the importation of prescription drugs under Title 26, Chapter 66,
Prescription Drug Affordability Act, in addition to the activities described in Subsections (1)
and (2), a unilateral act in the form of a trust or otherwise, in restraint of trade or commerce, is
unlawful.