§ 50-24.6-04 — Prior authorization program - Certification program

North Dakota § 50-24.6-04

• Jurisdiction: North Dakota
• Title 50: Public Welfare
• Ch. 50-24.6: Medical Assistance Drug Use Review and Authorization

Text

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.