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SB1716 - 572R - I Ver
REFERENCE TITLE:
clozapine; access; monitoring modifications
State of Arizona
Senate
Fifty-seventh Legislature
Second Regular Session
2026
SB 1716
Introduced by
Senators
Kuby: Alston, Diaz, Gonzales, Hatathlie, Miranda, Ortiz
AN
ACT
amending
title 20, Arizona Revised Statutes, by adding chapter 10; amending title 31,
chapter 1, article 4, Arizona Revised Statutes, by adding section 31-166;
amending title 31, chapter 2, article 2, Arizona Revised Statutes, by adding
section 31-243; amending title 36, chapter 29, article 1, Arizona Revised
Statutes, by adding section 36-2903.18; amending sections 36-2939
and 36-3431, Arizona Revised Statutes; relating to mental health
services.
(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 10, to read:
CHAPTER 10
HEALTH INSURER TREATMENT FOR PSYCHIATRIC
DISORDERS
ARTICLE 1. CLOZAPINE TREATMENT
START_STATUTE
20-2001.
Definitions
In this article, unless the context otherwise
requires:
1. "Health insurer" means a
disability insurer, group disability insurer, blanket disability insurer,
health care services organization, hospital service corporation, medical
service corporation or hospital, medical, dental and optometric service
corporation and includes the health insurer's designee.
2. "Participating provider"
means a provider that has been credentialed by a health insurer
or its designee to provide health care items or services to subscribers in at
least one of the health insurer's provider networks.
3. "Provider" means a
physician, hospital, behavioral health facility or other person or health care
institution that is licensed in this state or that is otherwise authorized to
furnish health care services in this state.
4. "Subscriber" means a
person who is eligible to receive health care benefits pursuant to a health
insurance policy or coverage issued or provided by a health insurer.
END_STATUTE
START_STATUTE
20-2002.
Clozapine; access; hematological monitoring; alternative means;
waiver or modification; prohibitions; definition
A. A health insurer shall provide
reimbursement for clozapine and may not deny, discontinue, interrupt, delay or
ration clozapine for a subscriber for whom clozapine has been prescribed by a
participating provider.
B. A subscriber who is prescribed
clozapine shall be provided access to reasonable and clinically appropriate
alternative means of hematological monitoring, including:
1. Mobile phlebotomy services.
2. Point-of-care or
nonvenous absolute neutrophil count testing methods, including individual
devices, if requested by the subscriber.
3. Clinical assistance and supplies
necessary to complete hematological monitoring, including in-home
services for homebound subscribers when clinically indicated.
C. Coverage for services, devices and
supplies prescribed pursuant to subsection B of this section may not be denied
solely based on cost, site of service, nontraditional testing modality or
administrative convenience if the method is approved by the United States food
and drug administration or is otherwise clinically accepted.
D. An insurer may not deny, delay,
interrupt or ration access to clozapine for a subscriber who is currently
prescribed or has previously been prescribed clozapine solely due to:
1. The absence of recent
hematological laboratory results.
2. Inability to comply with a
particular method, location or frequency of blood testing.
3. Institutional, payer or
administrative policies, including pharmacy benefits manager or utilization
management vendor policies that are unrelated to the subscriber's current
clinical condition.
E. A health insurer shall prohibit
dispensing practices that limit the quantity of clozapine solely to enforce
laboratory compliance.
F. A subscriber who is prescribed
clozapine has the right through written informed consent to waive or modify
recommended routine hematological monitoring requirements, including monitoring
referenced in United States food and drug administration-approved
prescribing information.� Before the waiver or modification of recommended
routine hematological monitoring requirements under this subsection:
1. The subscriber or the subscriber's
legal guardian shall be counseled by the subscriber's provider regarding:
(
a
) The purpose
and clinical value of hematological monitoring.
(
b
) Recommended
monitoring schedules referenced in prescribing information.
(
c
) The risks
of agranulocytosis and other hematological adverse effects.
(
d
) The risks
and benefits of reduced, modified or suspended monitoring.
2. The subscriber or the subscriber's
legal guardian shall provide written informed consent acknowledging these
risks.
3. The subscriber or the subscriber's
legal guardian shall agree to seek immediate medical evaluation if symptoms
consistent with infection, fever or hematologic abnormality occur.
G. A health insurer shall not impose
or enforce any requirement that results in a participating provider denying,
discontinuing or withholding clozapine solely because a subscriber elects to
waive or modify routine hematological monitoring pursuant to subsection F of
this section.� Clozapine may be withheld only if the participating provider
determines, based on an individualized clinical assessment, that continuation
presents an imminent and serious risk of medical harm and documents the
specific medical basis for that determination in the subscriber's medical
record.� For the purposes of this subsection, a participating provider's
generalized concerns regarding liability exposure, institutional policy,
deviation from customary monitoring practices or administrative convenience do
not constitute an imminent and serious risk of medical harm.
H. A subscriber shall not be subject
to more restrictive access standards, monitoring enforcement or medication
rationing for clozapine than for other medications with known serious medical
risks solely because of diagnosis, disability or perceived liability risk.
I. If a participating provider
withholds clozapine pursuant to subsection G of this section, the subscriber
has the right to both:
1. A clear explanation of the medical
basis for the decision.
2. Documentation of the determination
in the subscriber's medical record.
J. A provider may not discharge a
subscriber from care or transfer, penalize or otherwise retaliate against a
subscriber for exercising any right under this section, including informed
refusal or modification of routine hematological monitoring.
K. A provider who acts in good faith
in accordance with this section is not considered to have deviated from the
standard of care solely for providing or continuing clozapine treatment with
modified or waived hematological monitoring.
L. For the purposes of this section,
"imminent and serious risk of medical harm" means a condition that,
in the absence of immediate medical intervention, poses a substantial
likelihood of death or serious physical injury and is supported by current
clinical findings or symptoms.
END_STATUTE
Sec.2. Title 31, chapter 1, article 4, Arizona
Revised Statutes, is amended by adding section 31-166, to read:
START_STATUTE
31-166.
Inmates with psychiatric disorders; clozapine; access; treatment
protocols
A. A county jail shall provide an
inmate who is prescribed clozapine with access to clozapine treatment,
including during booking, intake, transfer and temporary housing, consistent
with section 36-2903.18.
B. A county jail shall allow for the
modification or waiver of routine hematological monitoring for clozapine in
accordance with section 36-2903.18 and may not deny, discontinue or
withhold clozapine except as prescribed by section 36-2903.18.
END_STATUTE
Sec. 3. Title 31, chapter 2, article 2, Arizona
Revised Statutes, is amended by adding section 31-243, to read:
START_STATUTE
31-243.
Inmates with psychiatric disorders; clozapine; access; treatment
protocols
A. The department or a private prison
provider that is contracted by the department shall provide an inmate who is
prescribed clozapine with access to clozapine treatment, including during
intake, transfer and relocation, consistent with section 36-2903.18.
B. The department or a private prison
provider shall allow for the modification or waiver of routine hematological
monitoring for clozapine in accordance with section 36-2903.18 and may
not deny, discontinue or withhold clozapine except as prescribed by section 36-2903.18.
END_STATUTE
Sec. 4. Title 36, chapter 29, article 1,
Arizona Revised Statutes, is amended by adding section 36-2903.18, to read:
START_STATUTE
36-2903.18.
Clozapine; access; hematological monitoring; alternative means;
waiver or modification; prohibitions; definition
A. The administration and its contractors
shall provide reimbursement for clozapine and may not deny, discontinue,
interrupt, delay or ration clozapine for a member for whom clozapine has been
prescribed by the member's provider.
B. A member who is prescribed
clozapine shall be provided access to reasonable and clinically appropriate
alternative means of hematological monitoring, including:
1. Mobile phlebotomy services.
2. Point-of-care or
nonvenous absolute neutrophil count testing methods, including individual
devices, if requested by the member.
3. Clinical assistance and supplies
necessary to complete hematological monitoring, including in-home
services for homebound members when clinically indicated.
C. Coverage for services, devices and
supplies prescribed pursuant to subsection B of this section may not be denied
solely based on cost, site of service, nontraditional testing modality or
administrative convenience if the method is approved by the United States food
and drug administration or is otherwise clinically accepted.
D. The administration or its
contractors may not deny, delay, interrupt or ration access to clozapine for a
member who is currently prescribed or has previously been prescribed clozapine
solely due to:
1. The absence of recent
hematological laboratory results.
2. Inability to comply with a
particular method, location or frequency of blood testing.
3. Institutional, payer or
administrative policies, including pharmacy benefits manager or utilization
management vendor policies that are unrelated to the member's current clinical
condition.
E. The administration and its
contractors shall prohibit dispensing practices that limit the quantity of
clozapine solely to enforce laboratory compliance.
F. A member who is prescribed
clozapine has the right through written informed consent to waive or modify
recommended routine hematological monitoring requirements, including monitoring
referenced in United States food and drug administration-approved
prescribing information. Before the waiver or modification of
recommended routine hematological monitoring requirements under this
subsection:
1. The member or the member's legal
guardian shall be counseled by the member's provider regarding:
(
a
) The purpose
and clinical value of hematological monitoring.
(
b
) Recommended
monitoring schedules referenced in prescribing information.
(
c
) The risks
of agranulocytosis and other hematological adverse effects.
(
d
) The risks
and benefits of reduced, modified or suspended monitoring.
2. The member or the member's legal
guardian shall provide written informed consent acknowledging these risks.
3. The member or the member's legal
guardian shall agree to seek immediate medical evaluation if symptoms
consistent with infection, fever or hematologic abnormality occur.
G. The administration or its
contractors shall not impose or enforce any requirement that results in a
provider denying, discontinuing or withholding clozapine solely because a
member elects to waive or modify routine hematological monitoring pursuant to
subsection F of this section.� Clozapine may be withheld only if the provider
determines, based on an individualized clinical assessment, that continuation
presents an imminent and serious risk of medical harm and documents the
specific medical basis for that determination in the member's medical
record. For the purposes of this subsection, a provider's
generalized concerns regarding liability exposure, institutional policy,
deviation from customary monitoring practices or administrative convenience do
not constitute an imminent and serious risk of medical harm.
H. The rights and protections
established by this section apply to members who are capable of providing
informed consent and to members who lack decisional capacity.� If a member
lacks decisional capacity, informed consent or authorization for continuation
of clozapine and any modification or waiver of routine hematological monitoring
may be provided by any of the following:
1. A court-appointed guardian.
2. A parent, legal guardian or other
authorized decision-maker, if the member is a minor.
3. A health care power of attorney or
other legally authorized surrogate.
4. If no such person is available,
the treating provider acting in good faith and in the member's best interests,
consistent with applicable state law.
I. The absence of a court-appointed
guardian or formal surrogate does not, by itself, constitute a basis to deny,
discontinue or withhold clozapine.
J. If a provider withholds clozapine
pursuant to subsection G of this section, the member has the right to both:
1. A clear explanation of the medical
basis for the decision.
2. Documentation of the determination
in the member's medical record.
K. A provider may not discharge a
member from care or transfer, penalize or otherwise retaliate against the
member for exercising any right under this section, including informed refusal
or modification of routine hematological monitoring.
L. A provider who acts in good faith
in accordance with this section is not considered to have deviated from the
standard of care solely for providing or continuing clozapine treatment with
modified or waived hematological monitoring.
M. A violation of this section
constitutes a failure to provide medically necessary services and is subject to
administrative sanctions, contractual remedies and other enforcement actions
available under this article.
N. This section applies during
transitions of care between settings and providers.
O. This section shall be construed to
ensure continuity of clozapine treatment for all members, including members
receiving services pursuant to article 2 of this chapter and members who are
minors.� This section does not allow the denial of treatment based on setting,
age or disability status.
P. For the purposes of this section,
"imminent and serious risk of medical harm" means a condition that,
in the absence of immediate medical intervention, poses a substantial
likelihood of death or serious physical injury and is supported by current
clinical findings or symptoms.
END_STATUTE
Sec. 5. Section 36-2939, Arizona Revised
Statutes, is amended to read:
START_STATUTE
36-2939.
Long-term care system services; definitions
A. The following services shall be provided by the
program contractors to members who are determined to need institutional
services pursuant to this article:
1. Nursing facility services other than services in
an institution for tuberculosis or mental disease.
2. Notwithstanding any other law, behavioral health
services if these services are not duplicative of long-term care services
provided as of January 30, 1993 under this subsection and are authorized
by the program contractor through the long-term care case management
system. If the administration is the program contractor, the
administration may authorize these services.
3. Hospice services. For the purposes of
this paragraph, "hospice" means a program of palliative and
supportive care for terminally ill members and their families or caregivers.
4. Case management services as provided in section
36-2938.
5. Health and medical services as provided in
section 36-2907.
6. Dental services as follows:
(a) Except as provided in subdivision (b) of this
paragraph, in an annual amount of not more than $1,000 per member.
(b) Subject to approval by the centers for medicare
and medicaid services, for persons treated at an Indian health service or
tribal facility, adult dental services that are eligible for a federal medical
assistance percentage of one hundred percent and that are in excess of the
limit prescribed in subdivision (a) of this paragraph.
7. Pursuant to the terms and conditions that are
approved by the centers for medicare and medicaid services and subject to
available funding, traditional healing services if both of the following apply:
(a) The member qualifies for services through the
Indian health service or a tribal facility pursuant to the conditions of
participation outlined in 42 Code of Federal Regulations section 136.12.
(b) The traditional healing service is delivered by
or through the Indian health service or a tribal facility.
8. Clozapine access and treatment
protocols as prescribed in section 36-2903.18 for members who are
prescribed clozapine.
B. In addition to the services prescribed in
subsection A of this section, the department, as a program contractor, shall
provide the following services if appropriate to members who have a
developmental disability as defined in section 36-551 and who are
determined to need institutional services pursuant to this article:
1. Intermediate care facility services for a member
who has a developmental disability as defined in section 36-551. For
purposes of this article, a facility shall meet all federally approved
standards and may only include the Arizona training program facilities, a state
owned and operated service center, state owned or operated community
residential settings and private facilities that contract with the department.
2. Home and community based services that may be
provided in a member's home, at an alternative residential setting as
prescribed in section 36-591 or at other behavioral health alternative
residential facilities licensed by the department of health services and
approved by the director of the Arizona health care cost containment system
administration and that may include:
(a) Home health, which means the provision of
nursing services, licensed health aide services, home health aide services or
medical supplies, equipment and appliances, that are provided on a part-time
or intermittent basis by a licensed home health agency within a member's
residence based on a physician's or allowed practitioner's orders and in
accordance with federal law. Physical therapy, occupational therapy,
or speech and audiology services provided by a home health agency may be
provided in accordance with federal law. Home health agencies shall
comply with federal bonding requirements in a manner prescribed by the
administration.
(b) Licensed health aide services, which means a
home health agency service provided pursuant to subsection G of this section
that is ordered by a physician or an allowed practitioner on the member's plan
of care and provided by a licensed health aide who is licensed pursuant to
title 32, chapter 15.
(c) Home health aide, which means a service that
provides intermittent health maintenance, continued treatment or monitoring of
a health condition and supportive care for activities of daily living provided
within a member's residence.
(d) Homemaker, which means a service that provides
assistance in the performance of activities related to household maintenance
within a member's residence.
(e) Personal care, which means a service that
provides assistance to meet essential physical needs within a member's
residence.
(f) Day care for persons with developmental
disabilities, which means a service that provides planned care supervision and
activities, personal care, activities of daily living skills training and
habilitation services in a group setting during a portion of a continuous
twenty-four-hour period.
(g) Habilitation, which means the provision of
physical therapy, occupational therapy, speech or audiology services or
training in independent living, special developmental skills, sensory-motor
development, behavior intervention, and orientation and mobility in accordance
with federal law.
(h) Respite care, which means a service that
provides short-term care and supervision available on a twenty-four-hour
basis.
(i) Transportation, which means a service that
provides or assists in obtaining transportation for the member.
(j) Other services or licensed or certified settings
approved by the director.
C. In addition to services prescribed in subsection
A of this section, home and community based services may be provided in a
member's home, in an adult foster care home as prescribed in section 36-401,
in an assisted living home or assisted living center as defined in section 36-401
or in a level one or level two behavioral health alternative residential
facility approved by the director by program contractors to all members who do
not have a developmental disability as defined in section 36-551 and are
determined to need institutional services pursuant to this
article. Members residing in an assisted living center must be
provided the choice of single occupancy. The director may also
approve other licensed residential facilities as appropriate on a case-by-case
basis for traumatic brain injured members. Home and community based
services may include the following:
1. Home health, which means the provision of nursing
services, home health aide services or medical supplies, equipment and
appliances, that are provided on a part-time or intermittent basis by a
licensed home health agency within a member's residence based on a physician's
or allowed practitioner's orders and in accordance with federal law.� Physical
therapy, occupational therapy, or speech and audiology services provided by a
home health agency may be provided in accordance with federal
law. Home health agencies shall comply with federal bonding
requirements in a manner prescribed by the administration.
2. Licensed health aide services, which means a home
health agency service provided pursuant to subsection G of this section that is
ordered by a physician or an allowed practitioner on the member's plan of care
and provided by a licensed health aide who is licensed pursuant to title 32,
chapter 15.
3. Home health aide, which means a service that
provides intermittent health maintenance, continued treatment or monitoring of
a health condition and supportive care for activities of daily living provided
within a member's residence.
4. Homemaker, which means a service that provides
assistance in the performance of activities related to household maintenance
within a member's residence.
5. Personal care, which means a service that
provides assistance to meet essential physical needs within a member's
residence.
6. Adult day health, which means a service that
provides planned care supervision and activities, personal care, personal
living skills training, meals and health monitoring in a group setting during a
portion of a continuous twenty-four-hour period. Adult
day health may also include preventive, therapeutic and restorative health
related services that do not include behavioral health services.
7. Habilitation, which means the provision of
physical therapy, occupational therapy, speech or audiology services or
training in independent living, special developmental skills, sensory-motor
development, behavior intervention, and orientation and mobility in accordance
with federal law.
8. Respite care, which means a service that provides
short-term care and supervision available on a twenty-four-hour
basis.
9. Transportation, which means a service that
provides or assists in obtaining transportation for the member.
10. Home delivered meals, which means a service that
provides for a nutritious meal that contains at least one-third of the
recommended dietary allowance for an individual and that is delivered to the
member's residence.
11. Other services or licensed or certified settings
approved by the director.
D. The amount of monies expended by program
contractors on home and community based services pursuant to subsection C of
this section shall be limited by the director in accordance with the federal
monies made available to this state for home and community based services
pursuant to subsection C of this section. The director shall
establish methods for allocating monies for home and community based services
to program contractors and shall monitor expenditures on home and community
based services by program contractors.
E. Notwithstanding subsections A, B, C, F and G of
this section, a service may not be provided that does not qualify for federal
monies available under title XIX of the social security act or the section 1115
waiver.
F. In addition to services provided pursuant to
subsections A, B and C of this section, the director may implement a
demonstration project to provide home and community based services to special
populations, including persons with disabilities who are eighteen years of age
or younger, are medically fragile, reside at home and would be eligible for
supplemental security income for the aged, blind or disabled or the state
supplemental payment program, except for the amount of their parent's income or
resources. In implementing this project, the director may provide
for parental contributions for the care of their child.
G. Consistent with the services provided pursuant to
subsections A, B, C and F of this section and subject to approval by the
centers for medicare and medicaid services, the director shall implement a
program under which licensed health aide services may be provided to members
who are under twenty-one years of age, who are eligible pursuant to
section 36-2934, including members with developmental disabilities as
defined in chapter 5.1, article 1 of this title, and who require continuous
skilled nursing or skilled nursing respite care services. The
licensed health aide services may be provided only by a parent, guardian or
family member who is a licensed health aide employed by a medicare-certified
home health agency service provider. Not later than sixty days after
the approval of the rules implementing section 32-1645, subsection C, the
director shall request any necessary approvals from the centers for medicare
and medicaid services to implement this subsection and to qualify for federal
monies available under title XIX of the social security act or the section 1115
waiver. The reimbursement rate for services provided under this
subsection shall reflect the special skills needed to meet the health care
needs of these members and shall exceed the reimbursement rate for home health
aide services.
H. Subject to section 36-562, the
administration by rule shall prescribe a deductible schedule for programs
provided to members who are eligible pursuant to subsection B of this section,
except that the administration shall implement a deductible based on family
income. In determining deductible amounts and whether a family is
required to have deductibles, the department shall use adjusted gross
income. Families whose adjusted gross income is at least four
hundred percent and less than or equal to five hundred percent of the federal
poverty guidelines shall have a deductible of two percent of adjusted gross
income.� Families whose adjusted gross income is more than five hundred percent
of adjusted gross income shall have a deductible of four percent of adjusted
gross income.� Only families whose children are under eighteen years of age and
who are members who are eligible pursuant to subsection B of this section may
be required to have a deductible for services. For the purposes of
this subsection, "deductible" means an amount a family, whose
children are under eighteen years of age and who are members who are eligible
pursuant to subsection B of this section, pays for services, other than
departmental case management and acute care services, before the department
will pay for services other than departmental case management and acute care
services.
I. For the purposes of this section:
1. "Allowed practitioner" means a nurse
practitioner who is certified pursuant to title 32, chapter 15, a clinical
nurse specialist who is certified pursuant to title 32, chapter 15 or a
physician assistant who is certified pursuant to title 32, chapter 25.
2. "Tribal facility" has the same meaning
prescribed in section 36-2981.
END_STATUTE
Sec. 6. Section 36-3431, Arizona Revised
Statutes, is amended to read:
START_STATUTE
36-3431.
Comprehensive behavioral health service system for children;
administration's duties
A. The administration shall develop and implement a
comprehensive behavioral health service system for children that includes the
following:
1. Annual needs assessment and resource assessment
studies.
2. Annual planning to develop policy issues, programs
and services.
3. Community education to increase public awareness
of the needs of children.
4. Centralized and coordinated screening and intake.
5. Coordinated case management.
6. A continuum of treatment services, which may
include the following:
(a) Home-based services.
(b) Prevention and early intervention.
(c) Psychological evaluation and consultation.
(d) Ancillary support services.
(e) Crisis intervention.
(f) Outpatient counseling.
(g) Independent living services.
(h) Secure residential treatment services for
seriously emotionally disturbed children.
(i) Residential treatment services for children's
substance abuse.
(j) Psychiatric hospitalization services.
7. Clozapine access and Treatment
protocols as prescribed in section 36-2903.18 for children who are
prescribed clozapine.
7.
8.
Evaluation that determines both cost
effectiveness and client outcome.
B. Subject to
legislative appropriation, the administration shall maintain the system
identified in subsection A of this section.
C. For the purposes of developing needs assessments
and resource assessments and for planning, the administration may consult and
coordinate with any state agency established for that purpose.
END_STATUTE