Oklahoma 2024 Regular Session

Oklahoma House Bill HB3379 Compare Versions

Version 1 (Old)

Version 2 (New)

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3		-	HB3379 HFLR Page 1
4		-	BOLD FACE denotes Committee Amendments. 1
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29		-	HOUSE OF REPRESENTATIVES - FLOOR VERSION
30		-
31	53		STATE OF OKLAHOMA
32	54
33	55		2nd Session of the 59th Legislature (2024)
34	56
35		-	HOUSE BILL 3379 By: McEntire, Deck, and West
36		-	(Tammy) of the House
37		-
38		-	and
39		-
40		-	Howard of the Senate
41		-
	57	+	HOUSE BILL 3379 By: McEntire
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47	63		AS INTRODUCED
48	64
49	65		An Act relating to prescriptions; creating the
50	66		Oklahoma Health Care Safety Net and Affordable
51	67		Prescriptions Accessibility Act ; defining terms;
52	68		prohibiting certain discriminatory actions related to
53	69		reimbursement of certain entities; prohibiting
54	70		certain discriminatory actions by a manufacturer or
55	71		distributor related to certain entities ; providing
56	72		for enforcement by the Attorney General and Insurance
57	73		Commissioner; providing for violations; providing for
58	74		federal preemption; providing for codification; and
59	75		providing an effective date .
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65		-
66		-
67	81		BE IT ENACTED BY THE PEOPLE OF T HE STATE OF OKLAHOMA:
68	82		SECTION 1. NEW LAW A new section of law to be codified
69	83		in the Oklahoma Statutes as Se ction 5400 of Title 36, unless there
70	84		is created a duplication in numbering, reads as follows:
	85	+	This act shall be known and may be cited as the "Oklahoma Health
	86	+	Care Safety Net and Affordable Pr escriptions Accessibility Act ".
	87	+	SECTION 2. NEW LAW A new section of law to be codified
	88	+	in the Oklahoma Statutes as Section 5401 of Title 36, unless there
	89	+	is created a duplication in numbering, reads as follows:
	90	+	As used in this act:
71	91
72		-	HB3379 HFLR Page 2
73		-	BOLD FACE denotes Committee Amendments. 1
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98		-	This act shall be known and may be cited as the "Oklahoma Health
99		-	Care Safety Net and Affordable Prescriptions Accessibility Act ".
100		-	SECTION 2. NEW LAW A new section of law to be codified
101		-	in the Oklahoma Statutes as Se ction 5401 of Title 36, unless there
102		-	is created a duplication in numbering, reads as follows:
103		-	As used in this act:
104	142		1. "340B drug" means a drug that has been subject to any offer
105	143		for reduced prices by a manufacturer purs uant to Section 256b of
106	144		Title 42 of the United States Code and is purchased by a covered
107	145		entity as defined in Section 256b(a)(4) of Title 42 of the Uni ted
108	146		States Code;
109	147		2. "340B entity" means an entity participating or authorized to
110	148		participate in the federal 340B drug discount program, as described
111	149		in Section 256b of Title 42 of the United States Code, including its
112	150		pharmacy, or any pharmacy contracted with the participating entity
113	151		to dispense drugs purchased through the 340B drug discount program;
114	152		3. "Pharmacy" means a pharmacy licensed by the Oklahoma State
115	153		Board of Pharmacy, except that patients who are provided pharmacy
116	154		care shall be physically located in the state; and
117	155		4. "Pharmacy benefit manager " means a person that performs
118	156		pharmacy benefits management and any other person acting for such
119	157		person under a contractual or employment relationship in the
120	158		performance of pharmacy benefits m anagement for a managed care
121	159		company, nonprofit hospital, medical service orga nization, insurance
	160	+	company, third-party payor or a health program administered by a
	161	+	department of this state .
	162	+	SECTION 3. NEW LAW A new section of law to be codified
	163	+	in the Oklahoma Statutes as Section 5402 of Title 36, unless there
	164	+	is created a duplication in numbering, reads as follows:
122	165
123		-	HB3379 HFLR Page 3
124		-	BOLD FACE denotes Committee Amendments. 1
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149		-	company, third-party payor or a health program administe red by a
150		-	department of this state .
151		-	SECTION 3. NEW LAW A new section of law to be codified
152		-	in the Oklahoma Statutes as Section 5402 of Title 36, unless there
153		-	is created a duplication in numbering, reads as follows:
154	216		A. 1. With respect to reimbursement to a 340B entity for 340B
155	217		drugs, a health insurance issuer, pharmacy benefit manager, other
156	218		third-party payor, or its agent shall not:
157	219		a. reimburse a 340B entity for 340B drugs at a rate lower
158	220		than that paid for the same drug to entities that are
159	221		not 340B entities or lower reimbursement for a claim
160	222		on the basis that the claim is for a 340B drug,
161	223		b. impose any terms or conditions on any 340B entity with
162	224		respect to any of the following that differ from such
163	225		terms or conditions applied to non -340B entities on
164	226		the basis that the entity participates in the federal
165	227		340B drug discount program set fo rth in Section 256b
166	228		of Title 42 of the United St ates Code or that a drug
167	229		is a 340B drug including, without limitation, any of
168	230		the following:
169	231		(1) fees, charges, clawbacks, or other adjustments or
170	232		assessments. For purposes of this subsection,
171	233		the term "other adjustments" includes placing any
172	234		additional requirements, restrictions, or
	235	+	unnecessary burdens upon the 340B entity that
	236	+	result in administrative costs or fees to the
	237	+	340B entity that are not placed upon other
	238	+	entities that do not participate in the 340B dru g
	239	+	discount program, including affiliate pharmacies
173	240
174		-	HB3379 HFLR Page 4
175		-	BOLD FACE denotes Committee Amendments. 1
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200		-	unnecessary burdens upon the 340B entity that
201		-	result in administrative costs or fees to the
202		-	340B entity that are not placed upon other
203		-	entities that do not participate in the 340B dru g
204		-	discount program, including affiliate pharmacies
205	291		of the health insurance issuer, pharmacy benefit
206	292		manager, or other third-party payor,
207	293		(2) dispensing fees that are less than the dispensing
208	294		fees for non-340B entities,
209	295		(3) restrictions or requirements r egarding
210	296		participation in standard or pref erred pharmacy
211	297		networks,
212	298		(4) requirements relating to the frequency or scope
213	299		of audits of inventory management s ystems,
214	300		(5) requirements that a claim for a drug include any
215	301		identification, billing modifier, attestation, or
216	302		other indication that a drug is a 340B drug in
217	303		order to be processed or resubmitted unless it is
218	304		required by the Centers for Medicare and Medicaid
219	305		Services or the Oklahoma Health Care Authority
220	306		for the administration of the Oklahoma Medicaid
221	307		program, or
	308	+	(6) any other restrictions, conditions, practices, or
	309	+	policies that are not imposed on non-340B
	310	+	entities.
	311	+	c. require a 340B entity to reverse, resubmit, or clarify
	312	+	a claim after the initial adjudication unless these
	313	+	actions are in the normal course of pha rmacy business
	314	+	and not related to 340B drug pricing,
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223		-	HB3379 HFLR Page 5
224		-	BOLD FACE denotes Committee Amendments. 1
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249		-	(6) any other restrictions, conditions, practices, or
250		-	policies that are not imposed on non-340B
251		-	entities.
252		-	c. require a 340B entity to revers e, resubmit, or clarify
253		-	a claim after the initial adjudication unless these
254		-	actions are in the normal course of pharmacy business
255		-	and not related to 340B drug pricing,
256	366		d. discriminate against a 340B entity in a manner that
257	367		prevents or interferes with any patient 's choice to
258	368		receive such drugs from the 340B entity, including the
259	369		administration of such drugs. For purposes of this
260	370		subsection, it is considered a discriminatory prac tice
261	371		that prevents or interferes with a patient 's choice to
262	372		receive drugs at a 340B entity if a health insurance
263	373		issuer, pharmacy benefit manager, or other third -party
264	374		payor places any additional requirements,
265	375		restrictions, or unnecessary burdens upon the 340B
266	376		entity that results in administrative costs or fees to
267	377		the 340B entity, including but not limited to ,
268	378		requiring a claim for a drug to include any
269	379		identification, billing modifier, attestatio n, or
270	380		other indication that a drug is a 340B drug in order
271	381		to be processed or resubmitted unless it is required
272	382		by the Centers for Medicare and Medicaid Services or
	383	+	the Oklahoma Health Care Authority in administration
	384	+	of the Oklahoma Medicaid program,
	385	+	e. include any other provision in a contract between a
	386	+	health insurance issuer, pharmacy benefit manager, or
	387	+	other third-party payor and a 340B entity that
	388	+	discriminates against the 340B entity or prevents or
	389	+	interferes with an individual 's choice to receive a
273	390
274		-	HB3379 HFLR Page 6
275		-	BOLD FACE denotes Committee Amendments. 1
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300		-	the Oklahoma Health Care Authority in administration
301		-	of the Oklahoma Medicaid program,
302		-	e. include any other provision in a contract between a
303		-	health insurance issuer, pharmacy benefit manager, or
304		-	other third-party payor and a 340B e ntity that
305		-	discriminates against the 340B entity or prevents or
306		-	interferes with an individual 's choice to receive a
307	441		prescription drug from a 340B entity, including the
308	442		administration of the drug, in person or via direct
309	443		delivery, mail, or other form of shipment, or creation
310	444		of a restriction or additional charge on a patient who
311	445		chooses to receive drugs from a 340B enti ty,
312	446		f. require or compel the submission of ingredient costs
313	447		or pricing data pertaining to 340B drugs to any health
314	448		insurance issuer, pharmacy benefit manager, or other
315	449		third-party payor,
316	450		g. exclude any 340B entity from the health insurance
317	451		issuer, pharmacy benefit manager, or other third -party
318	452		payor network on the basis that the 340B entity
319	453		dispenses drugs subject to an agreement under Section
320	454		256b of Title 42 of the United State Code , or refusing
321	455		to contract with a 340B entity for reasons other than
322	456		those that apply equally to non -340B entities.
	457	+	B. Nothing in this section applies to the Oklahoma Medicaid
	458	+	program as payor when Medicaid provides reimbursement for covered
	459	+	outpatient drugs as defined in section 1396r -8(k) of Title 42 of the
	460	+	United States Code.
	461	+	SECTION 4. NEW LAW A new section o f law to be codified
	462	+	in the Oklahoma Statutes as Section 5403 of Title 36, unless there
	463	+	is created a duplication in numbering, reads as follows:
323	464
324		-	HB3379 HFLR Page 7
325		-	BOLD FACE denotes Committee Amendments. 1
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350		-	B. Nothing in this section applies to the Oklahoma Medicaid
351		-	program as payor when Medicaid provides reimbursement for covered
352		-	outpatient drugs as defined in section 1396r -8(k) of Title 42 of the
353		-	United States Code.
354		-	SECTION 4. NEW LAW A new section o f law to be codified
355		-	in the Oklahoma Statutes as Section 5403 of Title 36, unless there
356		-	is created a duplication in numbering, reads as follows:
357	515		A. A manufacturer or distributor shall not deny, re strict,
358	516		prohibit, or otherwise interfere with, either direc tly or
359	517		indirectly, the acquisition of a 340B drug by, or delivery of a 340B
360	518		drug to, a pharmacy that is under contract with a 340B entity and is
361	519		authorized under such contract to receive and dispen se 340B drugs on
362	520		behalf of the covered entity unless such r eceipt is prohibited by
363	521		the United States Department of Health and Human Services.
364	522		B. A manufacturer or distributor shall not interfere with a
365	523		pharmacy contracted with a 340B entity.
366	524		SECTION 5. NEW LAW A new section of law to be co dified
367	525		in the Oklahoma Statutes as Section 5404 of Title 36, unless there
368	526		is created a duplication in numbering, reads as follows:
369	527		The Attorney General may make rules and regulations interpreting
370	528		the provisions of this act, and shall make recommendations t o the
371	529		Oklahoma Insurance Commissioner for enforcement with the
372	530		jurisdiction of the Insurance Commissioner.
	531	+	The Insurance Commissioner may censure, suspend, revoke , or
	532	+	refuse to issue or renew a lic ense of or levy a civil penalty
	533	+	against any person licensed under the insurance laws of this state
	534	+	for any violation of this act.
	535	+	In addition to or in lieu of any applicable censure, suspension
	536	+	or revocation of a license, a manufacturer, distributor, health
	537	+	insurance issuer, pharmacy benefit manager, other third -party payor,
	538	+	or its agent may be subject to a civil fine of not less than One
373	539
374		-	HB3379 HFLR Page 8
375		-	BOLD FACE denotes Committee Amendments. 1
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400		-	The Insurance Commissioner may censure, suspend, revoke , or
401		-	refuse to issue or renew a license of or levy a civil penalty
402		-	against any person licensed under the insurance laws of this state
403		-	for any violation of this act.
404		-	In addition to or in lieu of any applicable censure, suspension
405		-	or revocation of a license, a manufacturer, distributor, health
406		-	insurance issuer, pharmacy benefit manager, other third -party payor,
407		-	or its agent may be subject to a civil fine of not less than One
408	590		Hundred Dollars ($100.00) and not greater than Ten Thousand Dollars
409	591		($10,000.00) for each violation of the provisions of this act.
410	592		A violation occurs each time a prohibited act is committed.
411	593		SECTION 6. NEW LAW A new section of law to be codified
412	594		in the Oklahoma Statutes as Section 5405 of Title 36, unless there
413	595		is created a duplication in numbering, reads as follows:
414	596		A. Nothing in this section is to be construed or applied to be
415	597		less restrictive than federal law for a person or entity regulated
416	598		by this act.
417	599		B. Nothing in this act is to be construed or applied to be in
418	600		conflict with any of the following:
419	601		1. Applicable federal law and related regulations ; or
420	602		2. Other laws of this state if the state law is compatible with
421	603		applicable federal law.
422	604		C. Limited distribution of a drug required under section 355-1
423	605		of Title 21 of the Unite d States Code is not to be construed as a
424		-
425		-	HB3379 HFLR Page 9
426		-	BOLD FACE denotes Committee Amendments. 1
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451	606		violation of this section.
452	607		SECTION 7. This act shall become effective November 1, 2024.
453	608
454		-	COMMITTEE REPORT BY: COMMITTEE ON APPR OPRIATIONS AND BUDGET, dated
455		-	02/29/2024 - DO PASS, As Coauthored.
	609	+	59-2-9195 TJ 01/06/24