North Dakota 2025-2026 Regular Session

North Dakota Senate Bill SB2370 Compare Versions

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Version 2 (New)

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1		-	25.1364.03000
	1	+	25.1364.01002
	2	+	Title.02000
	3	+	Adopted by the Human Services
	4	+	Committee
2	5		Sixty-ninth
	6	+	February 10, 2025
3	7		Legislative Assembly
4	8		of North Dakota
5	9		Introduced by
6	10		Senators Cleary, Dever, Mathern
7	11		Representative McLeod
8		-	A BILL for an Act to create and enact a new chapter to title 26.1 of the North Dakota Century
9		-	Code, relating to prescription drug transparency reporting under the federal drug discount
10		-	program; to provide for a report; to provide a penalty; and to provide for application.
	12	+	A BILL for an Act to create and enact a new section to chapter 26.1-36 of the North Dakota
	13	+	Century Code, relating to individual and group health insurance coverage of insulin drugs and
	14	+	supplies; and to amend and reenact section 54-52.1-04.18 of the North Dakota Century Code,
	15	+	relating to health insurance benefits coverage of insulin drugs and supplies.
11	16		BE IT ENACTED BY THE LEGISLATIVE ASSEMBLY OF NORTH DAKOTA:
12		-	SECTION 1. A new chapter to title 26.1 of the North Dakota Century Code is created and
13		-	enacted as follows:
14		-	Definitions.
15		-	For purposes of this chapter:
16		-	1."Contract pharmacy" means a pharmacy that has a contract with a covered entity to
17		-	receive and dispense drugs to the covered entity's patients on its behalf.
18		-	2."Covered entity" means an entity participating or authorized to participate in the
19		-	program.
20		-	3."Department" means the insurance department.
21		-	4."Drug manufacturer" means the entity that holds the national drug code for a drug,
22		-	which is engaged in the production, preparation, propagation, compounding,
23		-	conversion, or processing of the drug or which is engaged in the packaging,
24		-	repackaging, labeling, relabeling, or distribution of the drug. The term does not include
25		-	a wholesale drug distributor or retail pharmacy licensed in this state.
26		-	5."Health care facility" means those facilities licensed under chapter 23-16.
27		-	6."Health insurer" means any entity that provides health insurance in this state. The term
28		-	includes an insurance company, prepaid limited service corporation, a fraternal benefit
29		-	society, a health maintenance organization, a nonprofit health service corporation, and
30		-	Page No. 1 25.1364.03000
31		-	ENGROSSED SENATE BILL NO. 2370
32		-	FIRST ENGROSSMENT
33		-	with House Amendments
	17	+	SECTION 1. A new section to chapter 26.1-36 of the North Dakota Century Code is created
	18	+	and enacted as follows:
	19	+	Health insurance benefits coverage - Insulin drug and supply out - of-pocket
	20	+	limitations.
	21	+	1. As used in this section:
	22	+	a. "Insulin drug" means a prescription drug that contains insulin and is used to treat
	23	+	a form of diabetes mellitus. The term does not include an insulin pump, an
	24	+	electronic insulin-administering smart pen, or a continuous glucose monitor, or
	25	+	supplies needed specifically for the use of such electronic devices. The term
	26	+	includes insulin in the following categories:
	27	+	(1) Rapid-acting insulin;
	28	+	(2) Short-acting insulin;
	29	+	(3) Intermediate-acting insulin;
	30	+	(4) Long-acting insulin;
	31	+	(5) Premixed insulin product;
	32	+	Page No. 1 25.1364.01002
	33	+	SENATE BILL NO. 2370
	34	+	PROPOSED AMENDMENTS TO
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57		-	any other entity providing a plan of health insurance or health benefits subject to state
58		-	insurance regulation.
59		-	7."Pharmacy benefits manager" has the same meaning as in section 19-03.6-01.
60		-	8."Program" means the federal drug discount program under 42 U.S.C. 256b.
61		-	Prescription drug transparency - Report.
62		-	1.The commissioner shall:
63		-	a.Prescribe the manner in which required reports under this section are submitted
64		-	to the department.
65		-	b.Beginning May 1, 2027, publish annually on the department's website a summary
66		-	of the information in the reports received by the department under this section.
67		-	c.Beginning June 1, 2027, report annually to the legislative management a
68		-	summary of findings of the reports received by the department.
69		-	2.The commissioner may adopt rules to carry out the responsibilities of this chapter.
70		-	3.A health care facility, contract pharmacy, or federally qualified health center
71		-	participating in the program shall report annually to the department:
72		-	a.Information describing how the entity's participation in the program benefits its
73		-	community by using savings from the program to fund, in whole or in part,
74		-	services that support community access to care, which the entity could not
75		-	continue without savings from the program. The report must include information
76		-	relating to charity care, prescription assistance programs, investments in health
77		-	care workforce development, the total annual costs in excess of Medicaid and
78		-	Medicare payments, examples of subsidized services, and the entity's
79		-	low - income and uninsured volume.
80		-	b.An accounting of any amount of program savings not used within this state.
81		-	c.The annual estimated savings from the program to the entity, comparing the
82		-	acquisition price of drugs under the program to the group purchasing
83		-	organization pricing. If the group purchasing organization pricing is not available
84		-	for a drug under the program, the acquisition price for that drug must be
85		-	compared to a price from another pricing source.
86		-	d.A comparison of the entity's estimated savings under the program to the entity's
87		-	total drug expenditures.
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121		-	e.A description of the entity's internal review and oversight of the program, which
122		-	must meet the requirements of federal rules and compliance guidelines.
123		-	f.The total aggregated payments made by the entity to contract pharmacies for
124		-	program services, if any.
125		-	4.A drug manufacturer participating in the program shall report annually to the
126		-	department:
127		-	a.The aggregate rebate, discount, or other financial incentive amounts or payments
128		-	provided to health insurers.
129		-	b.All trial data, including negative results and effects for any program drug.
130		-	c.Any government subsidy, tax incentive, or grant received for each drug approved
131		-	for sale in the United States.
132		-	5.If a drug manufacturer participating in the program denies a program discount or alters
133		-	drug pricing, the drug manufacturer shall submit a written explanation of the activity to
134		-	the department and all affected covered entities.
135		-	6.If a drug manufacturer overcharges a covered entity, the drug manufacturer shall
136		-	disclose the overcharge to the department and fully reimburse the covered entity.
137		-	7.A pharmacy benefits manager participating in the program shall report annually to the
138		-	department the:
139		-	a.Aggregate amount charged to employer plans for all drugs listed on respective
140		-	formularies.
141		-	b.Aggregate amount paid to pharmacies that are owned by or affiliated with the
142		-	pharmacy benefits manager.
143		-	c.Aggregate amount paid to pharmacies that are not owned by or affiliated with the
144		-	pharmacy benefits manager.
145		-	d.Aggregate savings from mail order pharmacies, specialty mail order pharmacies,
146		-	and community pharmacies or hospitals owned by or affiliated with the pharmacy
147		-	benefits manager.
148		-	e.Contract policies that reduce reimbursement to pharmacies for participating in the
149		-	program.
150		-	f.Aggregate amount of program contract rate reductions to pharmacies.
151		-	Page No. 3 25.1364.03000
	56	+	(6) Premixed insulin/GLP - 1 RA product; and
	57	+	(7) Concentrated human regular insulin.
	58	+	b. "Medical supplies for insulin dosing and administration" means supplies needed
	59	+	for proper insulin dosing, as well as supplies needed to detect or address medical
	60	+	emergencies in an individual using insulin to manage diabetes mellitus. The term
	61	+	does not include an insulin pump, an electronic insulin-administering smart pen,
	62	+	or a continuous glucose monitor, or supplies needed specifically for the use of
	63	+	such electronic devices. The term includes:
	64	+	(1) Blood glucose meters;
	65	+	(2) Blood glucose test strips;
	66	+	(3) Lancing devices and lancets;
	67	+	(4) Ketone testing supplies, such as urine strips, blood ketone meters, and
	68	+	blood ketone strips;
	69	+	(5) Glucagon, in injectable and nasal forms;
	70	+	(6) Insulin pen needles; and
	71	+	(7) Insulin syringes.
	72	+	c. "Pharmacy or distributor" means a pharmacy or medical supply company, or
	73	+	other medication or medical supply distributor filling a prescription.
	74	+	2. An insurance company, nonprofit health service corporation, or health maintenance
	75	+	organization may not deliver, issue, execute, or renew any health insurance policy,
	76	+	health service contract, or evidence of coverage on an individual, group, blanket,
	77	+	franchise, or association basis unless the policy, contract, or evidence of coverage
	78	+	provides benefits for insulin drug and medical supplies for insulin dosing and
	79	+	administration which complies with this section.
	80	+	3. The health benefit plan must limit out - of-pocket costs for a thirty - day supply of:
	81	+	a. Covered insulin drugs, which may not exceed twenty-five dollars per pharmacy or
	82	+	distributor, regardless of the quantity or type of insulin drug used to fill the
	83	+	covered individual's prescription needs.
	84	+	b. Covered medical supplies for insulin dosing and administration, the total of which
	85	+	may not exceed twenty-five dollars per pharmacy or distributor, regardless of the
	86	+	Page No. 2 25.1364.01002
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183		-	g.Difference in program rates for pharmacies owned or affiliated with the pharmacy
184		-	benefits manager compared to pharmacies that are not owned or affiliated with
185		-	the pharmacy benefits manager.
186		-	h.Average dispensing fee paid to pharmacies owned or affiliated with the pharmacy
187		-	benefits manager, including mail order pharmacies, compared to the Medicaid
188		-	rate of dispensing.
189		-	i.Average dispensing fee paid to pharmacies that are not owned or affiliated with
190		-	the pharmacy benefits manager, including mail order pharmacies, compared to
191		-	the Medicaid rate of dispensing.
192		-	8.A health insurer participating in the program shall report annually to the department:
193		-	a.The total of premium dollars collected annually from insured individuals and
194		-	employers.
195		-	b.The total of approved medical claims and prescription claims paid annually.
196		-	c.The health insurer's method for using excess revenues to reduce premiums and
197		-	patient out-of-pocket expenses.
198		-	d.Rebates, price protection payments, discounts, and other similar remunerations
199		-	received from drug manufacturers.
200		-	e.Any ownership interest the health insurer has in a pharmacy benefits manager,
201		-	and if a health insurer has an ownership interest, the amount of revenue the
202		-	pharmacy benefits manager provides to the health insurer.
203		-	f.A description of the health insurer's participation in the program, and to what
204		-	degree each business segment of the health insurer participates in the program.
205		-	g.Aggregate revenue generated from participation in the program.
206		-	h.Historical data and trends for employers and patients related to premiums,
207		-	deductibles, coinsurance, copayments, and any other out-of-pocket expenses.
208		-	i.Annual savings from claim denials in the program.
209		-	Confidentiality - Exception.
210		-	1.A report, document, material, or other information that is provided by a reporting entity
211		-	to the commissioner in accordance with this chapter is confidential and not subject to
212		-	section 44 - 04 - 18, a subpoena to the department, or a discovery request, or admissible
213		-	as evidence in a private civil action.
214		-	Page No. 4 25.1364.03000
	118	+	quantity or manufacturer of supplies used to fill the covered individual's
	119	+	prescription needs.
	120	+	4. The health benefit plan may not allow a pharmacy benefits manager or the pharmacy
	121	+	or distributor to charge, require the pharmacy or distributor to collect, or require a
	122	+	covered individual to make a payment for a covered insulin drug or medical supplies
	123	+	for insulin dosing and administration in an amount exceeding the out - of-pocket limits
	124	+	under subsection 3.
	125	+	5. The health benefit plan may not impose a deductible, copayment, coinsurance, or
	126	+	other cost-sharing requirement that causes out - of-pocket costs for prescribed insulin
	127	+	or medical supplies for insulin dosing and administration to exceed the amount under
	128	+	subsection 3.
	129	+	6. Subsection 3 does not require the health benefit plan to implement a particular cost-
	130	+	sharing structure and does not prevent the limitation of out - of-pocket costs to less than
	131	+	the amount specified under subsection 3. This section does not limit whether the
	132	+	health benefit plan classifies an insulin pump, an electronic insulin-administering smart
	133	+	pen, or a continuous glucose monitor as a drug or as a medical device or supply.
	134	+	7. If application of subsection 3 would result in the ineligibility of a health benefit plan that
	135	+	is a qualified high-deductible health plan to qualify as a health savings account under
	136	+	section 223 of the Internal Revenue Code [26 U.S.C. 223], the requirements of
	137	+	subsection 3 do not apply with respect to the deductible of the health benefit plan until
	138	+	after the enrollee has met the minimum deductible under section 26 U.S.C. 223.
	139	+	8. This section does not apply to the Medicare part D prescription drug coverage plan.
	140	+	SECTION 1. AMENDMENT. Section 54-52.1-04.18 of the North Dakota Century Code is
	141	+	amended and reenacted as follows:
	142	+	54-52.1-04.18. Health insurance benefits coverage - Insulin drug and supply out-of-
	143	+	pocket limitations. (Expired effective July 31, 2025)
	144	+	1.As used in this section:
	145	+	a."Insulin drug" means a prescription drug that contains insulin and is used to treat
	146	+	a form of diabetes mellitus. The term does not include an insulin pump, an
	147	+	electronic insulin-administering smart pen, or a continuous glucose monitor, or
	148	+	Page No. 3 25.1364.01002
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247		-	2.The commissioner may disclose on its website a summary of the information in the
248		-	reports and a summary of the findings of the reports, and use the document, material,
249		-	or other information submitted in a regulatory or legal action brought as a part of the
250		-	official duties of the commissioner.
251		-	3.A privilege or claim of confidentiality in the document, material, or information is not
252		-	waived as a result of disclosure to the commissioner under this chapter or as a result
253		-	of providing or disclosing information to the commissioner.
254		-	Civil penalty.
255		-	A health care facility, contract pharmacy, federally qualified health center, health insurer,
256		-	drug manufacturer, or pharmacy benefits manager that violates this chapter is subject to the
257		-	imposition by the attorney general of a civil penalty not to exceed ten thousand dollars for each
258		-	violation. The attorney general may waive or reduce a fine under this section upon a finding of
259		-	good cause, such as excusable neglect or other extenuating circumstances. The fine may be
260		-	collected and recovered in an action brought in the name of the state.
261		-	SECTION 2. APPLICATION. This Act applies to health care facilities beginning on
262		-	January 1, 2026, and to drug manufacturers, health insurers, and pharmacy benefits managers
263		-	beginning on January 1, 2027.
264		-	Page No. 5 25.1364.03000
	180	+	supplies needed specifically for the use of such electronic devices. The term
	181	+	includes insulin in the following categories:
	182	+	(1)Rapid-acting insulin;
	183	+	(2)Short-acting insulin;
	184	+	(3)Intermediate-acting insulin;
	185	+	(4)Long-acting insulin;
	186	+	(5)Premixed insulin product;
	187	+	(6)Premixed insulin/GLP-1 RA product; and
	188	+	(7)Concentrated human regular insulin.
	189	+	b."Medical supplies for insulin dosing and administration" means supplies needed
	190	+	for proper insulin dosing, as well as supplies needed to detect or address medical
	191	+	emergencies in an individual using insulin to manage diabetes mellitus. The term
	192	+	does not include an insulin pump, an electronic insulin-administering smart pen,
	193	+	or a continuous glucose monitor, or supplies needed specifically for the use of
	194	+	such electronic devices. The term includes:
	195	+	(1)Blood glucose meters;
	196	+	(2)Blood glucose test strips;
	197	+	(3)Lancing devices and lancets;
	198	+	(4)Ketone testing supplies, such as urine strips, blood ketone meters, and
	199	+	blood ketone strips;
	200	+	(5)Glucagon, in injectable and nasal forms;
	201	+	(6)Insulin pen needles; and
	202	+	(7)Insulin syringes.
	203	+	c."Pharmacy or distributor" means a pharmacy or medical supply company, or
	204	+	other medication or medical supply distributor filling a covered individual's
	205	+	prescriptions.
	206	+	2.The board shall provide health insurance benefits coverage that provides for insulin
	207	+	drug and medical supplies for insulin dosing and administration which complies with
	208	+	this sectionas provided under section 1 of this Act .
	209	+	3.The coverage must limit out-of-pocket costs for a thirty-day supply of:
	210	+	Page No. 4 25.1364.01002
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	242	+	a.Covered insulin drugs which may not exceed twenty-five dollars per pharmacy or
	243	+	distributor, regardless of the quantity or type of insulin drug used to fill the
	244	+	covered individual's prescription needs.
	245	+	b.Covered medical supplies for insulin dosing and administration, the total of which
	246	+	may not exceed twenty-five dollars per pharmacy or distributor, regardless of the
	247	+	quantity or manufacturer of supplies used to fill the covered individual's
	248	+	prescription needs.
	249	+	4.The coverage may not allow a pharmacy benefits manager or the pharmacy or
	250	+	distributor to charge, require the pharmacy or distributor to collect, or require a
	251	+	covered individual to make a payment for a covered insulin drug or medical supplies
	252	+	for insulin dosing and administration in an amount that exceeds the out-of-pocket limits
	253	+	set forth under subsection 3.
	254	+	5.The coverage may not impose a deductible, copayment, coinsurance, or other cost-
	255	+	sharing requirement that causes out-of-pocket costs for prescribed insulin or medical
	256	+	supplies for insulin dosing and administration to exceed the amount set forth under
	257	+	subsection 3.
	258	+	6.Subsection 3 does not require the coverage to implement a particular cost-sharing
	259	+	structure and does not prevent the limitation of out-of-pocket costs to less than the
	260	+	amount specified under subsection 3. Subsection 3 does not limit out-of-pocket costs
	261	+	on an insulin pump, an electronic insulin-administering smart pen, or a continuous
	262	+	glucose monitor. This section does not limit whether coverage classifies an insulin
	263	+	pump, an electronic insulin-administering smart pen, or a continuous glucose monitor
	264	+	as a drug or as a medical device or supply.
	265	+	7.If application of subsection 3 would result in the ineligibility of a health benefit plan that
	266	+	is a qualified high-deductible health plan to qualify as a health savings account under
	267	+	section 223 of the Internal Revenue Code [26 U.S.C. 223], the requirements of
	268	+	subsection 3 do not apply with respect to the deductible of the health benefit plan until
	269	+	after the enrollee has satisfied the minimum deductible under section 26 U.S.C. 223.
	270	+	8.This section does not apply to the Medicare part D prescription drug coverage plan.
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