HB 2449
Initials AG/MT Page 1 House Engrossed
ARIZONA HOUSE OF REPRESENTATIVES
Fifty-sixth Legislature
Second Regular Session
House: HHS DPA/SE 10-0-0-0
HB 2449: mental health conditions; medications; prohibitions
NOW: medication; authorization; mental illness
Sponsor: Representative Montenegro, LD 29
House Engrossed
Overview
Prohibits medications that are covered by AHCCCS and prescribed to address a mental
disorder from being subject to prior authorization or step therapy protocols unless certain
criteria are met. Applies these restrictions to contracts entered into, amended, extended or
renewed by October 1, 2025.
History
Step Therapy Protocol
Laws 2021, Chapter 431, established step therapy protocol, which is a protocol or program
that establishes the specific sequence in which prescription drugs that are for a specified
medical condition and are medically necessary for a particular patient are covered by a health
care insurer under a health care plan (A.R.S. § 20-3651). Step therapy protocol applies to any
health care plan that is subject to state law regulating insurance, provides prescription drug
benefits and includes coverage for a step therapy protocol regardless of how that coverage is
described. As well as a contractor, agent or similar entity that implements coverage for a step
therapy protocol on behalf of a health care plan, including a pharmacy benefit manager or
utilization review agent (A.R.S. § 20-3652).
Clinical Review Criteria
Clinical review criteria are the written screening procedures, decision abstracts, clinical
protocols and practice guidelines that are used by a health care insurer, pharmacy benefit
manager or utilization review agent to determine the medical necessity and appropriateness
of health care services. Clinical review criteria used by a health care insurer, pharmacy
benefit manager or utilization review agent to establish a step therapy protocol must be based
on clinical practice guidelines that: 1) recommend that the prescription drugs be taken in the
specific sequence required by the step therapy protocol; 2) are developed and endorsed by a
multidisciplinary panel of experts that manages conflicts of interest among the members of
the writing and review groups; 3) are based on high quality studies, research and medical
practice; 4) are created by an explicit and transparent process; and 5) are regularly updated
at least once a year through a review of new evidence and research and newly developed
treatments.
If no clinical practice guidelines exist, peer reviewed publications may be used. Each health
care insurer, pharmacy benefit manager and utilization review agent must annually certify
to the Department of Insurance and Financial Institutions that the clinical review criteria
used in the insurer's, manager's or agent's step therapy protocol for prescription drugs meet
the prescribed requirements (A.R.S. §§ 20-3651 and 20-3653). HB 2449
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Prior Authorization
Prior authorization requirement is: 1) a practice implemented by a health care services plan
or its utilization review agent in which coverage of a health care service is dependent on an
enrollee or a provider obtaining approval from the health care services plan before the service
is performed, received or prescribed, as applicable; 2) includes preadmission review,
pretreatment review, prospective review or utilization review procedures conducted by a
health care services plan or its utilization review agent before providing a health care service;
and 3) does not include case management or step therapy protocols.
Currently, a health care services plan or its utilization review agent may impose a prior
authorization requirement for health care services provided to an enrollee, except for
emergency ambulance services and emergency services, health care services arising after the
initial medical screening examination and immediately necessary stabilizing treatment. A
health care services plan must allow at least one modality of medication-assisted treatment
to be available without prior authorization (A.R.S. §§ 20-3401 and 20-3402).
Arizona Health Care Cost Containment System (AHCCCS)
Established in 1981, AHCCCS is Arizona's Medicaid program that oversees contracted health
plans for the delivery of health care to individuals and families who qualify for Medicaid and
other medical assistance programs. Through contracted health plans across the state,
AHCCCS delivers health care to qualifying individuals including low-income adults, their
children or people with certain disabilities. Current statute outlines covered health and
medical services offered to AHCCCS members (A.R.S. § 36-2907).
The AHCCCS Pharmacy and Therapeutics Com mittee (P&T Committee) is advisory to the
AHCCCS administration and is responsible for evaluating scientific evidence of the relative
safety, efficacy, effectiveness and clinical appropriateness of prescription drugs. The P&T
Committee makes recommendations to AHCCCS on developing and maintaining a statewide
drug list and prior authorization criteria as appropriate. The P&T Committee may also
evaluate individual drugs and therapeutic classes of drugs. Meetings are open to the public.
Provisions
1. Specifies that medications that are prescribed to address a mental disorder are not subject
to prior authorization or step therapy protocols, except that AHCCCS may impose step
therapy protocols that requires a member to try not more than one prescription drug
before receiving coverage for the drug prescribed by the member's physician or primary
care provider for persons who are at least 18 years of age and meet certain criteria.
(Sec. 1 and 2)
2. Specifies that AHCCCS can impose a step therapy protocol for members who are at least
18 years of age if all of the following apply:
a) the prescribed medication is either on the system's approved behavioral health drug
list or is currently available under the Medicaid Drug Rebate Program;
b) the medication is prescribed to prevent, assess or treat any of the specified qualifying
mental disorders as determined by the person's health care provider; and
c) the prescription does not exceed labeled dosages approved by the United States Food
and Drug Administration (FDA). (Sec. 1)
3. Specifies, for behavioral health services, AHCCCS can impose a step therapy protocol for
members who are at least 18 years of age if all of the following apply:
a) the medication is prescribed to prevent, assess or treat any of the specified qualifying
mental disorders as determined by the person's health care provider; HB 2449
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b) the prescribed medication is a covered benefit; and
c) the prescription does not exceed labeled dosages approved by FDA. (Sec. 2)
4. Requires AHCCCS when developing a preferred drug list for prescription drug coverage
to ensure that the P&T Committee reviews any drug that is newly approved by the FDA
to treat a qualifying mental disorder at the first committee meeting following the date of
the drug's approval. (Sec. 1)
5. Allows the drug to be reviewed at the second P&T Committee meeting following the date
of the drug's approval if there is not adequate time to review the newly approved drug.
(Sec. 1)
6. Contains an applicability clause. (Sec. 3)
7. Defines step therapy protocol. (Sec. 1 and 2)
8. Makes technical and conforming changes. (Sec. 1)