19.0277.02000
Sixty-sixth
Legislative Assembly SENATE BILL NO. 2290
of North Dakota
Introduced by
Senators J. Lee, Anderson, Hogan
Representatives Dockter, Westlind
1 A BILL for an Act to amend and reenact section 50-24.6-04 of the North Dakota Century Code,
2 relating to authorization of a Medicaid step therapy program based on the Medicare part B step
3 therapy program.
4 BE IT ENACTED BY THE LEGISLATIVE ASSEMBLY OF NORTH DAKOTA:
5 SECTION 1. AMENDMENT. Section 50-24.6-04 of the North Dakota Century Code is
6 amended and reenacted as follows:
7 50-24.6-04. Prior authorization program.
8 1. The department shall develop and implement a prior authorization program that meets
9 the requirements of 42 U.S.C. 1396r-8(d) to determine coverage of drug products
10 whenif a medical assistance recipient's health care provider prescribes a drug that is
11 identified as requiring prior authorization. Authorization must be granted for provision
12 of the drug if:
13 a. The drug not requiring prior authorization has not been effective, or with
14 reasonable certainty is not expected to be effective, in treating the recipient's
15 condition;
16 b. The drug not requiring prior authorization causes or is reasonably expected to
17 cause adverse or harmful reactions to the health of the recipient; or
18 c. The drug is prescribed for a medically accepted use supported by a compendium
19 or by approved product labeling unless there is a therapeutically equivalent drug
20 that is available without prior authorization.
21 2. For anya drug placed on the prior authorization program, the department shall provide
22 medical and clinical criteria, cost information, and utilization data to the drug use
23 review board for review and consideration. The board may consider department data
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1 and information from other sources to make a decision about placement of the drug on
2 prior authorization.
3 3. a. For individuals twenty-one years of age and older, except for quantity limits that
4 may be no less than the pharmaceutical manufacturer's package insert, brand
5 name drugs with a generic equivalent drug for which the cost to the state
6 postrebate is less than the brand name drugs, in the aggregate, or generic drugs
7 with a brand name equivalent drug for which the cost to the state postrebate is
8 less than the generic drug, the department may not prior authorize the following
9 medication classes:
10 (1) Antipsychotics;
11 (2) Antidepressants;
12 (3) Anticonvulsants;
13 (4) Antiretrovirals, for the treatment of human immunodeficiency virus; and
14 (5) Antineoplastic agents, for the treatment of cancer; and
15 (6) Stimulant medication used for the treatment of attention deficit disorder and
16 attention deficit hyperactivity disorder.
17 b. For individuals under twenty-one years of age, except for quantity limits that may
18 be no less than the pharmaceutical manufacturer's package insert, brand name
19 drugs with a generic equivalent drug for which the cost to the state postrebate is
20 less than the brand name drugs, in the aggregate, or generic drugs with a brand
21 name equivalent drug for which the cost to the state postrebate is less than the
22 generic drug, the department may not prior authorize the following medication
23 classes:
24 (1) Antipsychotics;
25 (2) Antidepressants;
26 (3) Anticonvulsants;
27 (4) Antiretrovirals, for the treatment of human immunodeficiency virus; and
28 (5) Antineoplastic agents, for the treatment of cancer; and
29 (6) Stimulant medication used for the treatment of attention deficit hyperactivity
30 disorder.
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1 c. The restrictions of subdivision b do not apply for individuals under twenty-one
2 years of age, who have five or more concurrent prescriptions for psychotropic
3 medications.
4 d. Prior authorization for individuals under twenty-one years of age is required for
5 five or more concurrent prescriptions for antipsychotics, antidepressants,
6 anticonvulsants, benzodiazepines, mood stabilizers, sedative, hypnotics, or
7 medications used for the treatment of attention deficit hyperactivity disorder. The
8 department shall grant authorization to exceed the limits after a prescriber
9 requesting authorization consults with a board certified pediatric psychiatrist
10 approved by the department.
11 4. The prior authorization program may not prior authorize antineoplastic agents for the
12 treatment of cancer, except through step therapy. If the department implements step
13 therapy under this subsection:
14 a. Step therapy is limited to new prescriptions or administrations and may not
15 disrupt ongoing therapies.
16 b. The department shall provide a prescriber an opportunity to submit a request for
17 an expedited exception if the provider believes it is necessary for the recipient to
18 have direct access to a drug that otherwise would be available only after trying an
19 alternative drug. Notwithstanding section 50-24.6-07 and chapter 28-32, the
20 department shall provide an expedited reconsideration process and the office of
21 administrative hearings shall provide an expedited administrative appeal process
22 for step therapy determinations.
23 c. In establishing a prior authorization step therapy program, the department shall
24 model the program on step therapy allowed under Medicare part B plans and the
25 program must comply with the requirements of 42 U.S.C. 1396r-8.
26 5. The department may use contractors to collect and analyze the documentation
27 required under this section and to facilitate the prior authorization program.
28 5.6. The department shall consult with the board in the course of adopting rules to
29 implement the prior authorization program. The rules must:
30 a. Establish policies and procedures necessary to implement the prior authorization
31 program.
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1 b. Develop a process that allows prescribers to furnish documentation required to
2 obtain approval for a drug without interfering with patient care activities.
3 c. Allow the board to establish panels of physicians and pharmacists which provide
4 expert guidance and recommendations to the board in considering specific drugs
5 or therapeutic classes of drugs to be included in the prior authorization program.
6 6.7. The department may negotiate additional rebates from drug manufacturers to
7 supplement the rebates required by federal law governing the medical assistance
8 program. Additionally, the department may join a multistate supplemental drug rebate
9 pool, and if the department negotiates additional rebates outside this pool, any other
10 manufacturer must be allowed to match those rebates.
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Statutes affected: INTRODUCED: 50-24.6-04
FIRST ENGROSSMENT: 50-24.6-04