SB1716 - 572R

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_STATUTE20-2001. 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_STATUTE20-2002. 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.

(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_STATUTE31-166. 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_STATUTE31-243. 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_STATUTE36-2903.18. 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.

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.

(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_STATUTE36-2939. 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_STATUTE36-3431. 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.

(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