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ARIZONA HOUSE OF REPRESENTATIVESFifty-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).
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 Committee (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;
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)
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HB 2449
Initials AG/MT Page 0 House Engrossed
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