# Title 50 — Public Welfare

## Chapter 50-24.6 — Medical Assistance Drug Use Review and Authorization

### § 50-24.6-01. Definitions.

As used in this chapter, unless the context otherwise requires:
1. "Board" means the drug use review board.
2. "Compendium" means the American hospital formulary service drug information,
United States pharmacopeia-drug information, the DRUGDEX information system,
American medical association drug evaluations, or nonproprietary peer-reviewed
medical literature.
3. "Department" means the department of health and human services.
4. "Drug use review" means a program as described in 42 U.S.C. 1396r-8(g)(2).
5. "Drug use review criteria" means standards approved by the board for use in
determining whether use of a drug is likely to be medically appropriate, to be medically
necessary, and not result in adverse medical outcomes.
6. "Prior authorization" means a process requiring the prescriber or the dispenser to
verify with the department or the department's contractor that proposed medical use of
a particular drug for a medical assistance program recipient meets predetermined
criteria for coverage by the medical assistance program.
### § 50-24.6-02. Drug use review board.

1. The board is established within the department for the implementation of a drug use
review program.
2. The board consists of seventeen members. The pharmacy administrator of the
department and the medical consultant to the department are ex officio nonvoting
board members who shall provide administrative services to the board. A majority of
the appointed members must be physicians and pharmacists participating in the
medical assistance program. Four or more of the appointed members must have
experience with a drug use review process or have participated in programs in which
prior authorization is used. The appointed members of the board must be:
a. Four physicians licensed in this state and actively engaged in the practice of
medicine, one of whom is a psychiatrist, appointed by the North Dakota medical
association;
b. Two physicians licensed in this state and actively engaged in the practice of
medicine, appointed by the commissioner of the department or the
commissioner's designee;
c. Four pharmacists licensed in this state and actively engaged in the practice of
pharmacy, appointed by the North Dakota pharmaceutical association;
d. Two pharmacists licensed in this state and actively engaged in the practice of
pharmacy, appointed by the commissioner of the department or the
commissioner's designee;
e. One individual who represents consumer interests, appointed by the governor;
f. One pharmacist or physician representing the brand pharmaceutical industry
appointed by the pharmaceutical research and manufacturers of America; and
g. One pharmacist or physician representing the generic pharmaceutical industry
appointed by the association for accessible medicines.
3. Appointed board members shall serve staggered three-year terms. An appointed
member may be reappointed for a period not to exceed three 3-year terms. A vacancy
on the board must be filled for the balance of the unexpired term from the appropriate
board category as provided under subsection 2. The commissioner of the department
or the commissioner's designee may replace an appointed member of the board who
fails to attend three consecutive meetings of the board without advance excuse or who
fails to perform the duties expected of a board member. The pharmaceutical industry
representatives are nonvoting board members.

4. Voting board members shall select a presiding officer and a vice presiding officer on an
annual basis from the board's voting membership. One-half or more of nonvacant
voting board member positions constitutes a quorum.
5. The board shall meet at least once every three months and may meet at other times at
the discretion of the presiding officer. A board member is entitled to receive from the
department or the department's vendor per diem compensation and reimbursement of
expenses as determined by the department or the department's vendor, except that no
compensation under this section may be paid to any board member who receives
compensation or salary as a state employee or official.
6. A board member appointed under subdivisions a through d of subsection 2 is not
subject to the bona fide resident of the state requirement under section 44-03-04 if the
board member is providing services to residents of the state receiving medical
assistance through telemedicine or telepharmacy. The affected association shall
continue to recruit in-state board members for that board member position and will
replace the nonresident board member once the affected association has enough
appointees for all of their board member positions.
7. A board member appointed under subdivision f or subdivision g of subsection 2 is not
subject to the bona fide resident of the state requirement under section 44-03-04.
### § 50-24.6-03. Duties of the board.

The board shall:
1. Cooperate with the department to create and implement a prospective and
retrospective drug use review program for outpatient prescription drugs under the
medical assistance program. This drug use review program must be based on a
compendium and drug use review criteria and must comply with 42 U.S.C. 1396r-8(g)
(3).
2. Advise and make recommendations regarding any rule proposed for adoption by the
department to implement the provisions of state and federal law related to drug use
review.
3. Receive and consider information regarding the drug use review process which is
provided by the department and by interested parties, including prescribers who treat
significant numbers of patients under the department's medical assistance program.
4. Review and recommend to the department any drugs to be included on prior
authorization status.
5. Review no less than once each year the status of the list of drugs that have been
placed on prior authorization.
6. Review and approve the prior authorization program process used by the department,
including the process to accommodate the provision of a drug benefit in an emergency
situation.
7. Propose remedial strategies to improve the quality of care and to promote effective
use of medical assistance program funds or recipient expenditures.
### § 50-24.6-04. Prior authorization program - Certification program.

1. The department shall develop and implement a prior authorization program that meets
the requirements of 42 U.S.C. 1396r-8(d) to determine coverage of drug products
when a medical assistance recipient's health care provider prescribes a drug that is
identified as requiring prior authorization. Authorization must be granted for provision
of the drug if:
a. The drug not requiring prior authorization has not been effective, or with
reasonable certainty is not expected to be effective, in treating the recipient's
condition;
b. The drug not requiring prior authorization causes or is reasonably expected to
cause adverse or harmful reactions to the health of the recipient; or
c. The drug is prescribed for a medically accepted use supported by a compendium
or by approved product labeling unless there is a therapeutically equivalent drug
that is available without prior authorization. The department shall work with the

medical assistance recipient's health care provider to assure treatment can be
found for diagnoses with no compendia supported medications.
2. For any drug placed on the prior authorization program, the department shall provide
medical and clinical criteria, cost information, and utilization data to the drug use
review board for review and consideration. The board may consider department data
and information from other sources to make a decision about placement of the drug on
prior authorization.
3. a. Except for quantity limits that may be no less than the pharmaceutical
manufacturer's package insert, brand name drugs with a generic equivalent drug
for which the cost to the state postrebate is less than the brand name drugs,
generic drugs with a brand name equivalent drug for which the cost to the state
postrebate is less than the generic drug, or medications that are considered line
extension drugs, the department may not prior authorize substantially all drugs in
the following medication classes:
(1) Antipsychotics;
(2) Antidepressants;
(3) Anticonvulsants;
(4) Antiretrovirals, for the treatment of human immunodeficiency virus;
(5) Antineoplastic agents; and
(6) Immunosuppressants, for prophylaxis of organ transplant rejection.
b. The restrictions of this subsection do not apply if prior authorization is required by
the centers for Medicare and Medicaid services.
c. The restrictions of this subsection do not apply to a medication class in
subdivision a if a manufacturer of a drug in that class excludes the department
from supplemental rebate offers or value-based purchasing agreement offers due
to the existence of the prior authorization exclusion in subdivision a.
d. As used in this subsection, "line extension drug" means a new formulation of a
drug. The term does not include an abuse-deterrent formulation of a drug.
e. As used in this subsection, "substantially all" means all drugs and unique dosage
forms in the medication classes outlined in paragraphs 1 through 6 of
subdivision a are expected to be covered without prior authorization, except:
(1) Multisource brands of the identical molecular structure;
(2) Extended release products when the immediate-release product is included;
(3) Products that have the same active ingredient or moiety; and
(4) Dosage forms that do not provide a unique route of administration.
4. The department may use contractors to collect and analyze the documentation
required under this section and to facilitate the prior authorization program.
5. The department shall consult with the board in the course of adopting rules to
implement the prior authorization program. The rules must:
a. Establish policies and procedures necessary to implement the prior authorization
program.
b. Develop a process that allows prescribers to furnish documentation required to
obtain approval for a drug without interfering with patient care activities.
c. Allow the board to establish panels of physicians and pharmacists which provide
expert guidance and recommendations to the board in considering specific drugs
or therapeutic classes of drugs to be included in the prior authorization program.
6. The department may negotiate additional rebates from drug manufacturers to
supplement the rebates required by federal law governing the medical assistance
program. Additionally, the department may join a multistate supplemental drug rebate
pool, and if the department negotiates additional rebates outside this pool, any other
manufacturer must be allowed to match those rebates.
7. The department shall develop a certification program to verify the medical necessity of
each medication in a regimen containing five or more concurrent prescriptions for
antipsychotic, antidepressant, anticonvulsant, benzodiazepine, mood stabilizer,
sedative hypnotic, or attention deficit hyperactivity disorder medications.

a. The certification program shall require each prescriber of a medication in an
impacted regimen to certify annually the medication prescribed is medically
necessary for the patient.
b. If a prescriber does not certify a medication as a medically necessary part of the
patient's regimen, the department may deny payment of the medication until the
medication is certified by the prescriber.
c. The certification program shall apply to individuals under the age of twenty-two
and may apply to other individuals at the discretion of the department.
### § 50-24.6-05. Public notice - Applicability.

1. The department shall provide thirty days' notice of all meetings of the board. The
notice requirement is met if the department provides notice of the meeting on the
department's website and provides, by written or electronic means, individual notice to
each person that has requested such notice. If the meeting agenda includes board
consideration of a change to the prior authorization program, the department shall
include in the notice a list of the affected drugs, and upon request the board shall
provide background information. Any interested party may attend a meeting of the
board and provide information or recommendations related to the inclusion of a drug in
a prior authorization program.
2. The department shall post on the department's website:
a. The most current and applicable list of drugs requiring prior authorization,
together with any limits on coverage of these drugs.
b. In downloadable format, forms necessary to complete prior authorization
requests.
c. Decisions regarding changes to the prior authorization program list. The
department shall allow a period of no less than thirty days for public comment
following posting on the website.
d. Meeting notice.
3. The department may not discontinue the provision of prescription drug benefits being
provided to medical assistance recipients before April 14, 2003, based solely on the
subsequent placement of the drug on the prior authorization program.
### § 50-24.6-06. Grievances.

Expired under S.L. 2003, ch. 430, § 12.
### § 50-24.6-07. Appeals.

A medical assistance recipient who is aggrieved by the placement of a drug on prior
authorization may appeal as authorized under chapter 28-32.
### § 50-24.6-08. Financial incentives prohibited.

The department may not offer or pay, directly or indirectly, any material inducement, bonus,
or other financial incentive to a participating provider based on the denial or delay of medically
necessary and appropriate prescription drug therapy or based on a reduction in the proportion
of recipients who receive prescription drug therapy under the medical assistance program.
### § 50-24.6-09. Maximum allowable costs and use of edits.

1. To promote efficiency and savings in the department's service to eligible medical
assistance program recipients, the department shall create and implement the
broadest possible list of drugs that can be paid at the maximum allowable costs. To
further promote efficiency and savings, the department shall maximize use of edit
programs that pertain to payment of medical assistance program pharmaceutical
claims. Upon request of a member of the legislative assembly, the department shall
provide to that member a summary of edit programs available to the medical
assistance program and a description of the department's progress in implementing
the edit programs.

2. The department shall participate in current and future innovative rebate and other
program options, including value-based purchasing programs, as feasible, reasonable,
and cost-effective for the state.
### § 50-24.6-10. Adoption of rules.

The department shall adopt rules to implement this chapter.
