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53	53	STATE OF OKLAHOMA
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55	55	1st Session of the 58th Legislature (2021)
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57	57	SENATE BILL 120 By: Standridge
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63	63	AS INTRODUCED
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65	65	An Act relating to prescription drugs; cr eating the
66	66	Prescription Drug Safety and Cost Reduction Pilot
67	67	Program Act; providing short ti tle; directing the
68	68	Oklahoma Health Care Authority to submit certain
69	69	application to the United States Secretary of Health
70	70	and Human Services; requiring the Authority to
71	71	identify and make available certain drugs to
72	72	participating pharmacies ; stipulating criteria for
73	73	drugs; requiring the Authority to purchase drugs from
74	74	certain suppliers; requiring issuance of unique
75	75	identification number to certain drugs for specified
76	76	purposes; limiting importation pilot progr am to
77	77	certain pharmacies; directing creation of certain
78	78	application and license verification process;
79	79	establishing certain fee; requiring the Authority to
80	80	contract with certain entity for administration of
81	81	the importation pilot program; prohibiting use of
82	82	certain entity; providing certain claims and
83	83	reimbursement process; setting reimbursement amounts;
84	84	prohibiting certain reimbursement; providing certain
85	85	appeals process for aggrieved pharmacy; providing for
86	86	certain adjustment and interest; prohibiting certa in
87	87	fees; prohibiting certain actions by pharmaceuti cal
88	88	manufacturer, supplier or other entity; imposing
89	89	certain duties on the Authority; directing the
90	90	Authority to form certain advisory council upon
91	91	approval of pilot program; stating purpose of
92	92	advisory council; directing promulgation of rules;
93	93	providing for codification; providing an effective
94	94	date; and declaring an emergency .
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99	99	BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
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151	151	SECTION 1. NEW LAW A new section of law to be codified
152	152	in the Oklahoma Statutes as Section 3092 of Title 63, unless there
153	153	is created a duplication in numbering, reads as follows:
154	154	A. This section shall be known and may be cited as the
155	155	“Prescription Drug Safety and Cost Reduction Importation Pilot
156	156	Program Act”.
157	157	B. The Oklahoma Health Care Authority shall submit an
158	158	application to the United States Secretary of Health and Human
159	159	Services for the purpose of establishing a prescription drug
160	160	importation pilot program for the state Medicaid program to import
161	161	pharmaceutical drugs from one or more countries approved by the
162	162	United States Food and Drug Administration (FDA). The importation
163	163	pilot program shall comply with the applicable requirements of 21
164	164	U.S.C., Section 384 including, but not limited to, the requirements
165	165	pertaining to safety and cost savings .
166	166	C. The Authority shall identify the top twenty (20) most
167	167	frequently prescribed drugs through the state Medicaid program that
168	168	have a large cost differential between Canadian and United States
169	169	average prices whose importation will create significant cost
170	170	savings in the state Medicaid program . Not less than six (6) months
171	171	following approval of the application described in subsection B of
172	172	this section, the Authority shall make available the top twenty (20)
173	173	highly prescribed drugs as provided in this paragraph to pharmacies
174	174	willing to participate. Prescription drugs identified:
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226	226	1. Shall be legally importable under applicable federal and
227	227	state law;
228	228	2. Shall not include a controlled dangerous substance;
229	229	3. Shall not include a biological product ;
230	230	4. Shall not include an infused drug, including a peritoneal
231	231	dialysis solution;
232	232	5. Shall not include marijuana, medical ma rijuana, cannabidiol
233	233	or related derivatives;
234	234	6. Shall not include an intravenously injected drug; and
235	235	7. Shall be in compliance with applicab le state and federal
236	236	standards for safety and effectiveness.
237	237	D. The Authority shall purchase drugs o nly from suppliers
238	238	approved by FDA in countries approved by FDA. Except for drugs to
239	239	which FDA issues a National Drug Code number, the Authority shall
240	240	issue a unique identification numbe r to each drug in the importation
241	241	pilot program for the purposes of tracking and submitting cl aims to
242	242	the Authority.
243	243	E. Only a retail pharmacy located in this state that has a
244	244	valid license issued by the State Board of Phar macy may participate
245	245	in the importation pilot program. The Authority shall create a
246	246	simple application for applying pharmacie s which shall include a
247	247	field for the pharmacy’s license number. The application shall be
248	248	made available on the website of the Au thority. Upon receipt of a
249	249	completed application, the Authority shall verify the license with
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301	301	the Board and issue a permit to the pharmacy within thirty (30)
302	302	calendar days authorizing the pharmacy to purchase drugs through the
303	303	importation pilot program.
304	304	F. The Authority shall establish a nominal fee -per-unit of
305	305	imported pharmaceutical drug s, not to exceed three percent (3%) of
306	306	the cost of the unit, to cover the costs of administration,
307	307	warehousing and distribution in addition to t he absolute cost of
308	308	importation.
309	309	G. The Authority shall c ontract with the entity currently
310	310	tasked with administering pharmacy b enefits for the state Medicaid
311	311	program on the effective date of this act for the purpose of
312	312	administering the importation pilot program. A pharmacy benefit
313	313	manager shall not be used for the importation pilot program.
314	314	H. 1. A pharmacy participating in the importation pilot
315	315	program shall submit claims to the Authority or the Authority’s
316	316	contracted third-party administrator, and shall be reimbursed
317	317	through the state Medicaid program as provided in this subsection.
318	318	2. The pharmacy shall be reimbursed in an amount equal to:
319	319	a. for a brand-name drug, the cost to the pharmacy of the
320	320	drug, plus fifteen percent (15%), plus Fifteen Dollars
321	321	($15.00), or
322	322	b. for a generic drug, the cost to the pharmacy of the
323	323	drug, plus thirty percent (30%), plus Fifteen Dollars
324	324	($15.00).
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376	376	3. No pharmacy shall be reimbursed in an amount more or less
377	377	than as provided in this subsection. If a pharmacy is reimbursed
378	378	less than as provided in this subsection, the pharmacy shall , upon
379	379	proof of purchase, be reimbursed the differe nce of the amount
380	380	provided in this subsection and the amount of the actual
381	381	reimbursement within thirty (30) days of an appeal and subsequent
382	382	decision by the Authority in favor of the pharmacy . Any adjustments
383	383	not reimbursed to the pharmacy within thirty ( 30) days of the
384	384	favorable decision shall be assessed interest with an annual
385	385	percentage rate of twenty-five percent (25%) of the owed adjustment
386	386	compounded daily until the payment is sent to the pharmacy. The
387	387	accrued interest shall be paid to the pharmacy. Except as provided
388	388	in this section, no fees or other charges shall be assessed to a
389	389	pharmacy in relation to the importation pilot program or any
390	390	purchases executed pursuant to the importation pilot program.
391	391	I. 1. A pharmaceutical manufacturer, supplier or any other
392	392	entity shall not:
393	393	a. give or receive kickbacks or rebates, or participate
394	394	in any other scheme that interferes with the
395	395	transparency of the importation pilot program or
396	396	interferes with pharmacies obtaining the lowest
397	397	possible prices on drugs purchased through the
398	398	importation pilot program,
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450	450	b. take any action, by agreement, unilaterally or
451	451	otherwise, that has the effect of fixing or otherwise
452	452	controlling the price that a pharmaceutical sup plier,
453	453	distributor or dispenser charges or advertises from
454	454	pharmaceuticals in the importation pilot program,
455	455	c. discriminate against a pharmaceutical supplier,
456	456	distributor or dispenser based on whether the
457	457	supplier, distributor or dispenser participates in the
458	458	importation pilot program, or
459	459	d. manipulate the pharmaceutical market in this state or
460	460	adversely affect consumer access to pharmaceuticals
461	461	under the importation pilot program;
462	462	2. The Authority shall:
463	463	a. ensure that savings are passed to consumers and not
464	464	recouped or clawed back, retroa ctively or otherwise,
465	465	by pharmaceutical manufacturers or any other entity,
466	466	b. ensure that the importation pilot program complies
467	467	with the requirements of 21 U.S.C, Section 360eee and
468	468	360eee-1, pertaining to the track and trace
469	469	requirements in Title II of the Drug Security and
470	470	Quality Act before imported prescription drugs come
471	471	into possession of the wholesaler, and
472	472	c. establish a process for seeking all appropriate
473	473	federal approvals, waivers, exemptions or agreements,
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525	525	or a combination thereof, as needed to enable all
526	526	covered entities enrolled in or e ligible for the
527	527	federal 340B Drug Pricing Prog ram to participate in
528	528	the importation pilot program to the fullest extent
529	529	possible without jeo pardizing eligibility in the 340B
530	530	Program.
531	531	J. Upon approval of the application described in subsection A
532	532	of this section, the Authority shall form an advisory council that
533	533	consists of key stakeholders including, but not limited to, consumer
534	534	and patient advocates, pharmacists, contracted providers under the
535	535	state Medicaid program and governmental agencies necessary to
536	536	propose rules and changes in law to enable the Authority to
537	537	implement the provisions of this section.
538	538	K. Upon approval of the application de scribed in subsection A
539	539	of this section, the Oklahoma Health Care Authority Board shall
540	540	promulgate rules to implement the provis ions of this section.
541	541	SECTION 2. This act shall become effective July 1, 2021.
542	542	SECTION 3. It being immediately necessary for the preservation
543	543	of the public peace, health or safety, an emergency is hereby
544	544	declared to exist, by reason whereof this act shall take effect and
545	545	be in full force from and after its passage and approval.
546	546
547	547	58-1-575 DC 12/9/2020 4:44:36 PM

Oklahoma 2022 Regular Session

Oklahoma Senate Bill SB120 Compare Versions