North Dakota 2025-2026 Regular Session

North Dakota Senate Bill SB2076 Compare Versions

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1		-	Sixty-ninth Legislative Assembly of North Dakota
2		-	In Regular Session Commencing Tuesday, January 7, 2025
	1	+	25.8085.02000
	2	+	Sixty-ninth
	3	+	Legislative Assembly
	4	+	of North Dakota
	5	+	Introduced by
	6	+	Human Services Committee
	7	+	(At the request of the Department of Health and Human Services)
	8	+	A BILL for an Act to amend and reenact section 50-24.6-04 of the North Dakota Century Code,
	9	+	relating to prior authorization and certification of medically necessary medication.
	10	+	BE IT ENACTED BY THE LEGISLATIVE ASSEMBLY OF NORTH DAKOTA:
	11	+	SECTION 1. AMENDMENT. Section 50-24.6-04 of the North Dakota Century Code is
	12	+	amended and reenacted as follows:
	13	+	50-24.6-04. Prior authorization program - Certification program.
	14	+	1.The department shall develop and implement a prior authorization program that meets
	15	+	the requirements of 42 U.S.C. 1396r-8(d) to determine coverage of drug products
	16	+	when a medical assistance recipient's health care provider prescribes a drug that is
	17	+	identified as requiring prior authorization. Authorization must be granted for provision
	18	+	of the drug if:
	19	+	a.The drug not requiring prior authorization has not been effective, or with
	20	+	reasonable certainty is not expected to be effective, in treating the recipient's
	21	+	condition;
	22	+	b.The drug not requiring prior authorization causes or is reasonably expected to
	23	+	cause adverse or harmful reactions to the health of the recipient; or
	24	+	c.The drug is prescribed for a medically accepted use supported by a compendium
	25	+	or by approved product labeling unless there is a therapeutically equivalent drug
	26	+	that is available without prior authorization. The department shall work with the
	27	+	medical assistance recipient's health care provider to assure treatment can be
	28	+	found for diagnoses with no compendia supported medications.
	29	+	Page No. 1 25.8085.02000
3	30		SENATE BILL NO. 2076
4		-	(Human Services Committee)
5		-	(At the request of the Department of Health and Human Services)
6		-	AN ACT to amend and reenact section 50-24.6-04 of the North Dakota Century Code, relating to prior
7		-	authorization and certification of medically necessary medication.
8		-	BE IT ENACTED BY THE LEGISLATIVE ASSEMBLY OF NORTH DAKOTA:
9		-	SECTION 1. AMENDMENT. Section 50-24.6-04 of the North Dakota Century Code is amended and
10		-	reenacted as follows:
11		-	50-24.6-04. Prior authorization program - Certification program.
12		-	1.The department shall develop and implement a prior authorization program that meets the
13		-	requirements of 42 U.S.C. 1396r-8(d) to determine coverage of drug products when a medical
14		-	assistance recipient's health care provider prescribes a drug that is identified as requiring prior
15		-	authorization. Authorization must be granted for provision of the drug if:
16		-	a.The drug not requiring prior authorization has not been effective, or with reasonable
17		-	certainty is not expected to be effective, in treating the recipient's condition;
18		-	b.The drug not requiring prior authorization causes or is reasonably expected to cause
19		-	adverse or harmful reactions to the health of the recipient; or
20		-	c.The drug is prescribed for a medically accepted use supported by a compendium or by
21		-	approved product labeling unless there is a therapeutically equivalent drug that is
22		-	available without prior authorization. The department shall work with the medical
23		-	assistance recipient's health care provider to assure treatment can be found for
24		-	diagnoses with no compendia supported medications.
25		-	2.For any drug placed on the prior authorization program, the department shall provide medical
26		-	and clinical criteria, cost information, and utilization data to the drug use review board for
27		-	review and consideration. The board may consider department data and information from
28		-	other sources to make a decision about placement of the drug on prior authorization.
29		-	3.a.For individuals eighteen years of age and older, exceptExcept for quantity limits that may
30		-	be no less than the pharmaceutical manufacturer's package insert, brand name drugs
31		-	with a generic equivalent drug for which the cost to the state postrebate is less than the
32		-	brand name drugs, generic drugs with a brand name equivalent drug for which the cost
33		-	to the state postrebate is less than the generic drug, or medications that are considered
34		-	line extension drugs, the department may not prior authorize substantially all drugs in the
35		-	following medication classes:
36		-	(1)Antipsychotics;
37		-	(2)Antidepressants;
38		-	(3)Anticonvulsants;
39		-	(4)Antiretrovirals, for the treatment of human immunodeficiency virus;
40		-	(5)Antineoplastic agents; and
41		-	(6)Immunosuppressants, for prophylaxis of organ transplant rejection. S. B. NO. 2076 - PAGE 2
42		-	b.For individuals under eighteen years of age, except for quantity limits that may be no less
43		-	than the pharmaceutical manufacturer's package insert, brand name drugs with a generic
44		-	equivalent drug for which the cost to the state postrebate is less than the brand name
45		-	drugs, generic drugs with a brand name equivalent drug for which the cost to the state
46		-	postrebate is less than the generic drug, or medications that are considered line
47		-	extension drugs, the department may not prior authorize substantially all drugs in the
48		-	following medication classes:
	31	+	SENATE BILL NO. 2076
	32	+	with House Amendments
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	53	+	21 Sixty-ninth
	54	+	Legislative Assembly
	55	+	2.For any drug placed on the prior authorization program, the department shall provide
	56	+	medical and clinical criteria, cost information, and utilization data to the drug use
	57	+	review board for review and consideration. The board may consider department data
	58	+	and information from other sources to make a decision about placement of the drug on
	59	+	prior authorization.
	60	+	3.a.For individuals eighteen years of age and older, exceptExcept for quantity limits
	61	+	that may be no less than the pharmaceutical manufacturer's package insert,
	62	+	brand name drugs with a generic equivalent drug for which the cost to the state
	63	+	postrebate is less than the brand name drugs, generic drugs with a brand name
	64	+	equivalent drug for which the cost to the state postrebate is less than the generic
	65	+	drug, or medications that are considered line extension drugs, the department
	66	+	may not prior authorize substantially all drugs in the following medication classes:
49	67		(1)Antipsychotics;
50	68		(2)Antidepressants;
51	69		(3)Anticonvulsants;
52	70		(4)Antiretrovirals, for the treatment of human immunodeficiency virus;
53	71		(5)Antineoplastic agents; and
54	72		(6)Immunosuppressants, for prophylaxis of organ transplant rejection.
55		-	c.The restrictions of subdivision b do not apply for individuals under eighteen years of age,
56		-	who have five or more concurrent prescriptions for psychotropic medications.
57		-	d.Prior authorization for individuals under eighteen years of age is required for five or more
58		-	concurrent prescriptions for antipsychotics, antidepressants, anticonvulsants,
59		-	benzodiazepines, mood stabilizers, sedative, hypnotics, or medications used for the
60		-	treatment of attention deficit hyperactivity disorder. The department shall grant
61		-	authorization to exceed the limits after a prescriber requesting authorization consults with
62		-	a board certified child and adolescent psychiatrist approved by the department.
63		-	e.The restrictions of this subsection do not apply if prior authorization is required by the
64		-	centers for Medicare and Medicaid services.
65		-	f.c.The restrictions of this subsection do not apply to a medication class in subdivision a if a
66		-	manufacturer of a drug in that class excludes the department from supplemental rebate
67		-	offers or value-based purchasing agreement offers due to the existence of the prior
68		-	authorization exclusion in subdivision a.
69		-	d.As used in this subsection, "line extension drug" means a new formulation of a drug. The
70		-	term does not include an abuse-deterrent formulation of a drug.
71		-	g.e.As used in this subsection, "substantially all" means that all drugs and unique dosage
72		-	forms in the medication classes outlined in paragraphs 1 through 6 of
73		-	subdivisionssubdivision a and b are expected to be covered without prior authorization,
74		-	with the following exceptionsexcept:
	73	+	b.For individuals under eighteen years of age, except for quantity limits that may be
	74	+	no less than the pharmaceutical manufacturer's package insert, brand name
	75	+	drugs with a generic equivalent drug for which the cost to the state postrebate is
	76	+	less than the brand name drugs, generic drugs with a brand name equivalent
	77	+	drug for which the cost to the state postrebate is less than the generic drug, or
	78	+	medications that are considered line extension drugs, the department may not
	79	+	prior authorize substantially all drugs in the following medication classes:
	80	+	(1)Antipsychotics;
	81	+	(2)Antidepressants;
	82	+	(3)Anticonvulsants;
	83	+	(4)Antiretrovirals, for the treatment of human immunodeficiency virus;
	84	+	(5)Antineoplastic agents; and
	85	+	(6)Immunosuppressants, for prophylaxis of organ transplant rejection.
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	117	+	31 Sixty-ninth
	118	+	Legislative Assembly
	119	+	c.The restrictions of subdivision b do not apply for individuals under eighteen years
	120	+	of age, who have five or more concurrent prescriptions for psychotropic
	121	+	medications.
	122	+	d.Prior authorization for individuals under eighteen years of age is required for five
	123	+	or more concurrent prescriptions for antipsychotics, antidepressants,
	124	+	anticonvulsants, benzodiazepines, mood stabilizers, sedative, hypnotics, or
	125	+	medications used for the treatment of attention deficit hyperactivity disorder. The
	126	+	department shall grant authorization to exceed the limits after a prescriber
	127	+	requesting authorization consults with a board certified child and adolescent
	128	+	psychiatrist approved by the department.
	129	+	e.The restrictions of this subsection do not apply if prior authorization is required by
	130	+	the centers for Medicare and Medicaid services.
	131	+	f.c.The restrictions of this subsection do not apply to a medication class in
	132	+	subdivision a if a manufacturer of a drug in that class excludes the department
	133	+	from supplemental rebate offers or value-based purchasing agreement offers due
	134	+	to the existence of the prior authorization exclusion in subdivision a.
	135	+	d.As used in this subsection, "line extension drug" means a new formulation of a
	136	+	drug. The term does not include an abuse-deterrent formulation of a drug.
	137	+	g.e.As used in this subsection, "substantially all" means that all drugs and unique
	138	+	dosage forms in the medication classes outlined in paragraphs 1 through 6 of
	139	+	subdivisionssubdivision a and b are expected to be covered without prior
	140	+	authorization, with the following exceptionsexcept:
75	141		(1)Multisource brands of the identical molecular structure;
76	142		(2)Extended release products when the immediate-release product is included;
77	143		(3)Products that have the same active ingredient or moiety; and
78	144		(4)Dosage forms that do not provide a unique route of administration.
79		-	4.The department may use contractors to collect and analyze the documentation required under
80		-	this section and to facilitate the prior authorization program.
81		-	5.The department shall consult with the board in the course of adopting rules to implement the
82		-	prior authorization program. The rules must: S. B. NO. 2076 - PAGE 3
	145	+	4.The department may use contractors to collect and analyze the documentation
	146	+	required under this section and to facilitate the prior authorization program.
	147	+	5.The department shall consult with the board in the course of adopting rules to
	148	+	implement the prior authorization program. The rules must:
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83	181		a.Establish policies and procedures necessary to implement the prior authorization
84	182		program.
85		-	b.Develop a process that allows prescribers to furnish documentation required to obtain
86		-	approval for a drug without interfering with patient care activities.
87		-	c.Allow the board to establish panels of physicians and pharmacists which provide expert
88		-	guidance and recommendations to the board in considering specific drugs or therapeutic
89		-	classes of drugs to be included in the prior authorization program.
90		-	6.The department may negotiate additional rebates from drug manufacturers to supplement the
91		-	rebates required by federal law governing the medical assistance program. Additionally, the
92		-	department may join a multistate supplemental drug rebate pool, and if the department
93		-	negotiates additional rebates outside this pool, any other manufacturer must be allowed to
94		-	match those rebates.
95		-	7.The department shall develop a certification program to verify the medical necessity of each
96		-	medication in a regimen containing five or more concurrent prescriptions for antipsychotic,
97		-	antidepressant, anticonvulsant, benzodiazepine, mood stabilizer, sedative hypnotic, or
98		-	attention deficit hyperactivity disorder medications.
99		-	a.The certification program shall require each prescriber of a medication in an impacted
100		-	regimen to certify annually the medication prescribed is medically necessary for the
101		-	patient.
102		-	b.If a prescriber does not certify a medication as a medically necessary part of the patient's
103		-	regimen, the department may deny payment of the medication until the medication is
104		-	certified by the prescriber.
105		-	c.The certification program shall apply to individuals under the age of twenty - two and may
106		-	apply to other individuals at the discretion of the department. S. B. NO. 2076 - PAGE 4
107		-	____________________________ ____________________________
108		-	President of the Senate Speaker of the House
109		-	____________________________ ____________________________
110		-	Secretary of the Senate Chief Clerk of the House
111		-	This certifies that the within bill originated in the Senate of the Sixty-ninth Legislative Assembly of North
112		-	Dakota and is known on the records of that body as Senate Bill No. 2076.
113		-	Senate Vote:Yeas 46 Nays 0 Absent 1
114		-	House Vote: Yeas 92 Nays 0 Absent 2
115		-	____________________________
116		-	Secretary of the Senate
117		-	Received by the Governor at ________M. on _____________________________________, 2025.
118		-	Approved at ________M. on __________________________________________________, 2025.
119		-	____________________________
120		-	Governor
121		-	Filed in this office this ___________day of _______________________________________, 2025,
122		-	at ________ o’clock ________M.
123		-	____________________________
124		-	Secretary of State
	183	+	b.Develop a process that allows prescribers to furnish documentation required to
	184	+	obtain approval for a drug without interfering with patient care activities.
	185	+	c.Allow the board to establish panels of physicians and pharmacists which provide
	186	+	expert guidance and recommendations to the board in considering specific drugs
	187	+	or therapeutic classes of drugs to be included in the prior authorization program.
	188	+	6.The department may negotiate additional rebates from drug manufacturers to
	189	+	supplement the rebates required by federal law governing the medical assistance
	190	+	program. Additionally, the department may join a multistate supplemental drug rebate
	191	+	pool, and if the department negotiates additional rebates outside this pool, any other
	192	+	manufacturer must be allowed to match those rebates.
	193	+	7.The department shall develop a certification program to verify the medical necessity of
	194	+	each medication in a regimen containing five or more concurrent prescriptions for
	195	+	antipsychotic, antidepressant, anticonvulsant, benzodiazepine, mood stabilizer,
	196	+	sedative hypnotic, or attention deficit hyperactivity disorder medications.
	197	+	a.The certification program shall require each prescriber of a medication in an
	198	+	impacted regimen to certify annually the medication prescribed is medically
	199	+	necessary for the patient.
	200	+	b.If a prescriber does not certify a medication as a medically necessary part of the
	201	+	patient's regimen, the department may deny payment of the medication until the
	202	+	medication is certified by the prescriber.
	203	+	c.The certification program shall apply to individuals under the age of twenty - two
	204	+	and may apply to other individuals at the discretion of the department.
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