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REFERENCE TITLE: insurance;
prescription drugs; step therapy |
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State of
Arizona House of
Representatives Fifty-fourth
Legislature Second Regular
Session 2020 |
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HB 2420 |
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Introduced by Representatives Barto: Blackman, Cobb, Shah |
AN ACT
Amending title
20, Arizona Revised Statutes, by adding chapter 28; relating to prescription
drugs.
(TEXT OF BILL BEGINS ON NEXT PAGE)
Be it enacted by the Legislature of the State of Arizona:
Section 1. Title 20, Arizona Revised Statutes, is amended by adding chapter 28, to read:
CHAPTER 28
STEP THERAPY
ARTICLE 1. GENERAL PROVISIONS
20-3501. Definitions
In this article, unless the context otherwise
requires:
1. "Clinical practice
guidelines" means a systematically developed statement to assist health
care providers and patients in making decisions about appropriate health care
for specific clinical circumstances and conditions.
2. "Clinical review
criteria" means the written screening procedures, decision abstracts,
clinical protocols and practice guidelines that are used by a health care
insurer, pharmacy benefits manager or utilization review organization to
determine the medical necessity and appropriateness of health care services.
3. "Exigent circumstance"
means an insured, enrollee or subscriber is either:
(a) Experiencing
a health condition that could seriously jeopardize the insured's, enrollee's or
subscriber's life, health or ability to regain maximum function.
(b) Undergoing
a current course of treatment.
4. "Health care insurer"
means a disability insurer, group disability insurer, blanket disability
insurer, health care services organization, hospital service corporation,
medical service corporation or hospital and medical service corporation.
5. "Health care plan" means
a policy, contract or evidence of coverage that a health care insurer,
including a contractor pursuant to title 36, chapter 29, article 1, issues to
an insured, enrollee or subscriber.
6. "Medically appropriate"
means appropriate under the applicable standard of care:
(a) To improve
or preserve health, life or function.
(b) To slow the
deterioration of health, life or function.
(c) For the
early screening, prevention, evaluation, diagnosis or treatment of a disease,
condition, illness or injury.
7. "Pharmaceutical sample"
means a unit of a prescription drug that is not intended to be sold but is
intended to promote the sale of the prescription drug.
8. "Pharmacy benefits
manager" means a person who administers pharmacy benefits for a health
care insurer.
9. "Step therapy exception"
means a step therapy protocol that is overridden in favor of immediate coverage
of a health care provider's selected prescription drug.
10. "Step therapy protocol"
means a protocol or program that establishes the specific sequence in which
prescription drugs that are for a specified medical condition and that are
medically appropriate for a particular patient are covered by a health care
insurer under a health care plan.
11. "Utilization review"
means a system for reviewing the appropriate and efficient allocation of
inpatient hospital resources, inpatient medical services and outpatient surgery
services that are being given or are proposed to be given to a patient and of
any medical, surgical and health care services or claims for services that may
be covered by a health care insurer depending on determinable contingencies,
including without limitation outpatient services, in office consultations with
medical specialists, specialized diagnostic testing, mental health services,
emergency care and inpatient and outpatient hospital services. Utilization review does not include elective
requests for the clarification of coverage.
12. "Utilization review organization" means an entity that conducts utilization review, other than a pharmacy benefits manager or health care insurer performing utilization review pursuant to its own health care plans.
20-3502. Applicability
This article applies to any health care plan
that provides prescription drug benefits and that includes coverage for a step
therapy protocol regardless of how that coverage is described.
20-3503. Clinical review
criteria
A. Clinical review criteria that are used by a health
care insurer, pharmacy benefits manager or utilization review organization
to establish a step therapy protocol shall 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. Except
as provided in subsection B of this section, 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 of the following:
(a) 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.
(b) Using a
methodologist to work with writing groups to provide objectivity in data
analysis and ranking of evidence through preparing evidence tables and
facilitating consensus.
(c) Offering
opportunities for public review and comments.
3. Are based on high quality studies, research and medical
practice.
4. Are created by an explicit and transparent process
that does all of the following:
(a) Minimizes biases and
conflicts of interest.
(b) Explains the
relationship between treatment options and outcomes.
(c) Rates the quality of the
evidence supporting recommendations.
(d) Considers relevant
patient subgroups and preferences.
5. Are continually updated through a
review of new evidence and research and newly developed treatments.
B. If no clinical practice guidelines
exist that meet the requirements prescribed in subsection A, paragraph 2 of
this section, peer reviewed publications may be used.
C. When considering clinical review
criteria to establish a step therapy protocol, a utilization review agent shall
also consider the needs of atypical patient populations and diagnoses.
D. Each health care insurer, pharmacy
benefits manager and utilization review organization shall annually certify to
the department that the clinical review criteria used in the insurer's,
manager's or organization's step therapy protocol for prescription drugs meet
the requirements prescribed by this article.
On the department's request, the health care insurer, pharmacy benefits
manager or utilization review organization shall submit the insurer's,
manager's or organization's clinical review criteria for approval.
E. This section does not require a
health care insurer or this state to establish a new entity to develop clinical
review criteria used for a step therapy protocol.
20-3504. Exceptions; process
A. Notwithstanding any other law, if
coverage of a prescription drug for the treatment of any medical condition is
restricted for use by a health care insurer, pharmacy benefits manager or
utilization review organization through the use of a step therapy protocol, the
patient and prescribing practitioner shall have access to a clear and
convenient process to request a step therapy exception determination. A
health care insurer, pharmacy benefits manager or utilization review
organization may use its existing medical exceptions process to satisfy this
requirement. The process shall be made
easily accessible on the health care insurer's, health benefit plan's, pharmacy
benefits manager's or utilization review organization's website.
B. A step therapy exception determination request shall
be granted if sufficient evidence is submitted to establish any of the
following applies:
1. The
required prescription drug is contraindicated or will likely cause an adverse
reaction by or physical or mental harm to the patient.
2. 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.
3. 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 pharmacologic class or with the same mechanism of
action, and the prescription drug was discontinued due to lack of efficacy or
effectiveness, diminished effect or an adverse event.
4. The required prescription drug is not in the best
interest of the patient based on medical necessity.
5. The patient remained stable on a prescription drug
selected by the patient's health care provider for the medical condition under
consideration while on the patient's current or previous health care plan. This paragraph is not intended to encourage
the use of a pharmaceutical sample for the sole purpose of meeting the
requirements for a step therapy exception determination.
C. On
granting a step therapy exception determination, the health care insurer, pharmacy benefits manager or utilization review organization shall authorize coverage for the
prescription drug prescribed by the patient's treating health care provider.
D. Unless an exigent circumstance
exists, a health care insurer, pharmacy benefits manager or utilization review
organization shall respond to a request for a step therapy exception
determination within seventy‑two hours after receiving all documentation
the health care insurer, pharmacy benefits manager or utilization review
organization requires and DISCLOSEs pursuant to subsection A of this
section. If an exigent circumstance
exists, The health care insurer, pharmacy benefits manager or utilization
review organization shall respond to the request within twenty‑four hours
after receiving all documentation the health care insurer, pharmacy benefits
manager or utilization review organization requires and DISCLOSEs pursuant to
subsection A of this section. If the
health care insurer, pharmacy benefits manager or utilization review
organization does not respond within the time period prescribed by this
subsection, the step therapy exception is deemed granted.
E. An insured, enrollee or subscriber
may appeal an adverse step therapy exception determination.
F. This section does not prevent either of the following:
1. A
health care insurer, pharmacy benefits manager or utilization review organization
from requiring a patient to try a generic equivalent before providing coverage
for the equivalent branded prescription drug.
2. A health care provider from prescribing a prescription drug that is determined to be medically appropriate.
Sec. 2. Department of insurance and financial institutions; rulemaking exemption
For the purposes of this act, the department of insurance and financial institutions is exempt from the rulemaking requirements of title 41, chapter 6, Arizona Revised Statutes, for one year after the effective date of this act.
Sec. 3. Applicability
This act applies to any policy, contract or evidence of coverage
delivered, issued for delivery or renewed on or after December 31, 2021.