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STATE OF OKLAHOMA
1st Session of the 58th Legislature (2021)
SENATE BILL 120 By: Standridge
AS INTRODUCED
An Act relating to prescription drugs; cr eating the
Prescription Drug Safety and Cost Reduction Pilot
Program Act; providing short ti tle; directing the
Oklahoma Health Care Authority to submit certain
application to the United States Secretary of Health
and Human Services; requiring the Authority to
identify and make available certain drugs to
participating pharmacies ; stipulating criteria for
drugs; requiring the Authority to purchase drugs from
certain suppliers; requiring issuance of unique
identification number to certain drugs for specified
purposes; limiting importation pilot progr am to
certain pharmacies; directing creation of certain
application and license verification process;
establishing certain fee; requiring the Authority to
contract with certain entity for administration of
the importation pilot program; prohibiting use of
certain entity; providing certain claims and
reimbursement process; setting reimbursement amounts;
prohibiting certain reimbursement; providing certain
appeals process for aggrieved pharmacy; providing for
certain adjustment and interest; prohibiting certa in
fees; prohibiting certain actions by pharmaceuti cal
manufacturer, supplier or other entity; imposing
certain duties on the Authority; directing the
Authority to form certain advisory council upon
approval of pilot program; stating purpose of
advisory council; directing promulgation of rules;
providing for codification; providing an effective
date; and declaring an emergency .
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
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SECTION 1. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 3092 of Title 63, unless there
is created a duplication in numbering, reads as follows:
A. This section shall be known and may be cited as the
“Prescription Drug Safety and Cost Reduction Importation Pilot
Program Act”.
B. The Oklahoma Health Care Authority shall submit an
application to the United States Secretary of Health and Human
Services for the purpose of establishing a prescription drug
importation pilot program for the state Medicaid program to import
pharmaceutical drugs from one or more countries approved by the
United States Food and Drug Administration (FDA). The importation
pilot program shall comply with the applicable requirements of 21
U.S.C., Section 384 including, but not limited to, the requirements
pertaining to safety and cost savings .
C. The Authority shall identify the top twenty (20) most
frequently prescribed drugs through the state Medicaid program that
have a large cost differential between Canadian and United States
average prices whose importation will create significant cost
savings in the state Medicaid program . Not less than six (6) months
following approval of the application described in subsection B of
this section, the Authority shall make available the top twenty (20)
highly prescribed drugs as provided in this paragraph to pharmacies
willing to participate. Prescription drugs identified:
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1. Shall be legally importable under applicable federal and
state law;
2. Shall not include a controlled dangerous substance;
3. Shall not include a biological product ;
4. Shall not include an infused drug, including a peritoneal
dialysis solution;
5. Shall not include marijuana, medical ma rijuana, cannabidiol
or related derivatives;
6. Shall not include an intravenously injected drug; and
7. Shall be in compliance with applicab le state and federal
standards for safety and effectiveness.
D. The Authority shall purchase drugs o nly from suppliers
approved by FDA in countries approved by FDA. Except for drugs to
which FDA issues a National Drug Code number, the Authority shall
issue a unique identification numbe r to each drug in the importation
pilot program for the purposes of tracking and submitting cl aims to
the Authority.
E. Only a retail pharmacy located in this state that has a
valid license issued by the State Board of Phar macy may participate
in the importation pilot program. The Authority shall create a
simple application for applying pharmacie s which shall include a
field for the pharmacy’s license number. The application shall be
made available on the website of the Au thority. Upon receipt of a
completed application, the Authority shall verify the license with
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the Board and issue a permit to the pharmacy within thirty (30)
calendar days authorizing the pharmacy to purchase drugs through the
importation pilot program.
F. The Authority shall establish a nominal fee -per-unit of
imported pharmaceutical drug s, not to exceed three percent (3%) of
the cost of the unit, to cover the costs of administration,
warehousing and distribution in addition to t he absolute cost of
importation.
G. The Authority shall c ontract with the entity currently
tasked with administering pharmacy b enefits for the state Medicaid
program on the effective date of this act for the purpose of
administering the importation pilot program. A pharmacy benefit
manager shall not be used for the importation pilot program.
H. 1. A pharmacy participating in the importation pilot
program shall submit claims to the Authority or the Authority’s
contracted third-party administrator, and shall be reimbursed
through the state Medicaid program as provided in this subsection.
2. The pharmacy shall be reimbursed in an amount equal to:
a. for a brand-name drug, the cost to the pharmacy of the
drug, plus fifteen percent (15%), plus Fifteen Dollars
($15.00), or
b. for a generic drug, the cost to the pharmacy of the
drug, plus thirty percent (30%), plus Fifteen Dollars
($15.00).
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3. No pharmacy shall be reimbursed in an amount more or less
than as provided in this subsection. If a pharmacy is reimbursed
less than as provided in this subsection, the pharmacy shall , upon
proof of purchase, be reimbursed the differe nce of the amount
provided in this subsection and the amount of the actual
reimbursement within thirty (30) days of an appeal and subsequent
decision by the Authority in favor of the pharmacy . Any adjustments
not reimbursed to the pharmacy within thirty ( 30) days of the
favorable decision shall be assessed interest with an annual
percentage rate of twenty-five percent (25%) of the owed adjustment
compounded daily until the payment is sent to the pharmacy. The
accrued interest shall be paid to the pharmacy. Except as provided
in this section, no fees or other charges shall be assessed to a
pharmacy in relation to the importation pilot program or any
purchases executed pursuant to the importation pilot program.
I. 1. A pharmaceutical manufacturer, supplier or any other
entity shall not:
a. give or receive kickbacks or rebates, or participate
in any other scheme that interferes with the
transparency of the importation pilot program or
interferes with pharmacies obtaining the lowest
possible prices on drugs purchased through the
importation pilot program,
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b. take any action, by agreement, unilaterally or
otherwise, that has the effect of fixing or otherwise
controlling the price that a pharmaceutical sup plier,
distributor or dispenser charges or advertises from
pharmaceuticals in the importation pilot program,
c. discriminate against a pharmaceutical supplier,
distributor or dispenser based on whether the
supplier, distributor or dispenser participates in the
importation pilot program, or
d. manipulate the pharmaceutical market in this state or
adversely affect consumer access to pharmaceuticals
under the importation pilot program;
2. The Authority shall:
a. ensure that savings are passed to consumers and not
recouped or clawed back, retroa ctively or otherwise,
by pharmaceutical manufacturers or any other entity,
b. ensure that the importation pilot program complies
with the requirements of 21 U.S.C, Section 360eee and
360eee-1, pertaining to the track and trace
requirements in Title II of the Drug Security and
Quality Act before imported prescription drugs come
into possession of the wholesaler, and
c. establish a process for seeking all appropriate
federal approvals, waivers, exemptions or agreements,
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or a combination thereof, as needed to enable all
covered entities enrolled in or e ligible for the
federal 340B Drug Pricing Prog ram to participate in
the importation pilot program to the fullest extent
possible without jeo pardizing eligibility in the 340B
Program.
J. Upon approval of the application described in subsection A
of this section, the Authority shall form an advisory council that
consists of key stakeholders including, but not limited to, consumer
and patient advocates, pharmacists, contracted providers under the
state Medicaid program and governmental agencies necessary to
propose rules and changes in law to enable the Authority to
implement the provisions of this section.
K. Upon approval of the application de scribed in subsection A
of this section, the Oklahoma Health Care Authority Board shall
promulgate rules to implement the provis ions of this section.
SECTION 2. This act shall become effective July 1, 2021.
SECTION 3. It being immediately necessary for the preservation
of the public peace, health or safety, an emergency is hereby
declared to exist, by reason whereof this act shall take effect and
be in full force from and after its passage and approval.
58-1-575 DC 12/9/2020 4:44:36 PM