ARIZONA HOUSE OF REPRESENTATIVES

Fifty-fourth Legislature

Second Regular Session

House: HHS DP 9-0-0-0

HB 2420: insurance; prescription drugs; step therapy

Sponsor:  Representative Barto, LD 15

House Engrossed

Overview

Sets forth clinical review criteria for step therapy protocols and outlines the process for exceptions to the protocols.

History

Step therapy, also called step protocol is a type of prior authorization requirement that begins medication for a medical condition with a drug therapy and progresses to other therapies if necessary.

 

Provisions

1.    ☐ Prop 105 (45 votes) ☐ Prop 108 (40 votes) ☐ Emergency (40 votes) ☐ Fiscal NoteApplies this law to any health care plan that provides prescription drug benefits and that includes coverage for a step therapy protocol. (Sec. 1)

Clinical Review Criteria

2.    Establishes that clinical review criteria used by a health care insurer, pharmacy benefits manager (PBM) or utilization review organization (URO) be based on guidelines that:

a)    Recommend prescription drugs be taken in the specific sequence required by the step therapy protocol;

b)    Are developed and endorsed by a multidisciplinary panel of experts that manages conflicts of interest among the members of the writing and review groups by doing all the following:

i.      Requiring the members to disclose any potential conflict of interest with an entity, including a health care insurer or pharmaceutical manufacturer, and recuse themselves from voting if they have a conflict of interest;

ii.     Using a methodologist to work with writing groups to provide objectivity in data analysis and ranking of evidence through preparing evidence tables and facilitation consensus;

iii.    Offering opportunities for public review and comment;

c)    Are based on high quality studies, research and medical practice;

d)    Are created by an explicit and transparent process that does all the following:

i.      Minimizes biases and conflicts of interest;

ii.     Explains the relationship between treatment options and outcomes;

iii.    Rates the quality of the evidence supporting the recommendations;

iv.   Considers relevant patient subgroups and preferences; and

e)    Are continually updated through a review of new evidence and research and newly developed treatments. (Sec. 1)

3.    Allows peer reviewed publications to be used. (Sec. 1)

4.    Requires a utilization review agent to consider the needs of atypical patient populations and diagnoses when considering clinical review criteria for step therapy. (Sec. 1)

5.    Requires each health care insurer, PBM and URO to annually certify to the Arizona Department of Insurance (DOI) that the criteria used in the insurer's, manager's or organization's step therapy protocol meets requirements. (Sec. 1)

6.    Specifies that on request of DOI, the health care insurer, PBM or URO must submit the insurer's, manager's or organization's clinical review for approval. (Sec. 1)

7.    States there is no requirement for a health care insurer to establish a new entity to develop clinical review criteria for step therapy protocols. (Sec. 1)

Exceptions; Process

8.    Allows for a process to request a step therapy exception determination and allows a health care insurer, PBM or URO to use its existing medical exceptions process. The process must be made accessible on the health care insurer's, health benefit plan's, PBM's or URO's website. (Sec. 1)

9.    Requires a step therapy exception be granted if sufficient evidence is submitted to establish any of the following:

a)    The required prescription drug is contraindicated or will likely cause an adverse reaction by or physical or mental harm to the patient;

b)    The required prescription drug is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug regimen;

c)    The patient has tried the required prescription drug while under the patient's current or previous health care plan, or another prescription drug in the same pharmacological class or with the same mechanism of action, and the drug was discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event;

d)    The required prescription drug is not in the best interest of the patient based on medical necessity;

e)    The patient remained stable on a prescribed drug selected by the provider for the medical condition under consideration while on the current or previous health plan. A health care provider may not use a pharmaceutical sample for the purpose of qualifying for an exception to step therapy. (Sec. 1)

10.  Requires the health care insurer, PBM or URO to authorize coverage for the prescription drug prescribed on granting a step therapy exception. (Sec. 1)

11.  Requires the health care insurer, PBM or URO to respond to a request for a step therapy determination within 72 hours after receiving all documentation, unless an exigent circumstance exists. (Sec. 1)

12.  States that if an exigent circumstance exists, the health care insurer, the PBM or the URO must respond to the request within 24 hours after receiving all documentation and disclosures. (Sec. 1)

13.  Stipulates that if the health care insurer, the PBM or the URO does not respond within the time period prescribed, the step therapy exception is deemed granted. (Sec. 1)

14.  Allows for an appeal of an adverse step therapy exception determination. (Sec. 1)

15.  States the foregoing provisions do not prevent either of the following:

a)    A health care insurer, PBM or URO from requiring a patient to try a generic equivalent before providing coverage for the equivalent branded drug; and

b)    A health care provider from prescribing a drug that is determined to be medically appropriate. (Sec. 1)

16.  Exempts, for purposes of this act, the Department of Insurance and Financial Institutions from the rulemaking requirement. (Sec. 2)

17.  Applies this act to any policy, contract or evidence of coverage delivered or renewed effective January 1, 2022. (Sec. 3)

18.  Defines clinical practice guidelines, clinical review criteria, exigent circumstance, health care insurer, health care plan, medically appropriate, pharmaceutical sample, pharmacy benefits manager, step therapy exception, step therapy protocol, utilization review and utilization review organization. (Sec. 1)

 

 

 

 

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Initials IG                     House Engrossed

 

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