Off-label use and coverage of drug treatment to treat pediatric acute-onset neuropsychiatric syndrome and pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection — Legislative findings — Definitions.
Ark. Code Ann. § 23-79-1905
in effect(a) The General Assembly finds that:
(1) Pediatric acute-onset neuropsychiatric syndrome, also known as “PANS”, is a clinically defined disorder characterized by the sudden onset of obsessive-compulsive symptoms or eating restrictions, accompanied by two (2) or more symptoms of acute behavioral deterioration or motor and sensory changes, or both;
(2) Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, also known as “PANDAS”, is a term used to describe a subset of symptoms affecting children and adolescents within the broader PANS classification;
(3) Other states may require coverage for off-label use of drug treatments to treat pediatric acute-onset neuropsychiatric syndrome and pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection; and
(4) Arkansas does not require coverage for off-label use of drug treatments to treat patients who are diagnosed with pediatric acute-onset neuropsychiatric syndrome and pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections.
(b) As used in this section:
(1)(A) “Health benefit plan” means an individual, blanket, or any group plan, policy, or contract for healthcare services issued, renewed, or extended in this state by a healthcare insurer, health maintenance organization, hospital medical service corporation, or self-insured governmental or church plan in this state.
(B) “Health benefit plan” includes:
(i) A plan offered by a risk-based provider organization as established under the Medicaid Provider-Led Organized Care Act, § 20-77-2701 et seq.;
(ii) Indemnity and managed care plans; and
(iii) Plans providing health benefits to state and public school employees under § 21-5-401 et seq.
(C) “Health benefit plan” does not include:
(i) A plan that provides only dental benefits or eye and vision care benefits;
(ii) A disability income plan;
(iii) A credit insurance plan;
(iv) Insurance coverage issued as a supplement to liability insurance;
(v) Medical payments under an automobile or homeowners insurance plan;
(vi) A health benefit plan provided under Arkansas Constitution, Article 5, § 32, the Workers' Compensation Law, § 11-9-101 et seq., and the Public Employee Workers' Compensation Act, § 21-5-601 et seq.;
(vii) A plan that provides only indemnity for hospital confinement;
(viii) An accident-only plan; or
(ix) A specified disease plan; and
(2)(A) “Healthcare insurer” means any insurance company, hospital and medical service corporation, or health maintenance organization that issues or delivers health benefit plans in this state and is subject to any of the following laws:
(i) The insurance laws of this state;
(ii) Section 23-75-101 et seq., pertaining to hospital and medical service corporations;
(iii) Section 23-76-101 et seq., pertaining to health maintenance organizations; or
(iv) A risk-based provider organization established under the Medicaid Provider-Led Organized Care Act, § 20-77-2701 et seq.
(B) “Healthcare insurer” does not include an entity that provides only dental benefits or eye and vision care benefits.
(c)(1) Except as provided in subsection (f) of this section, a health benefit plan that is offered, issued, or renewed in this state, including a plan offered by a risk-based provider organization established under the Medicaid Provider-Led Organized Care Act, § 20-77-2701 et seq., shall provide coverage for off-label use of intravenous immunoglobulin, also known as “IVIG”, to treat individuals diagnosed with pediatric acute-onset neuropsychiatric syndrome or pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, or both, on or after January 1, 2022, under a patient-specific treatment plan consistent with established protocols and rules to be developed by the Insurance Commissioner, in consultation with the Childhood Post-infectious Autoimmune Encephalopathy Center of Excellence.
(2) Rules to implement this subdivision have to be promulgated by August 31, 2023.
(d) The coverage for use of drug treatment to treat pediatric acute-onset neuropsychiatric syndrome and pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection under this section:
(1) May be subject to policy deductions or copayment requirements of a healthcare insurer or a health benefit plan; and
(2) Does not diminish or limit benefits otherwise allowable under a health benefit plan.
(e) The Insurance Commissioner shall develop and promulgate rules for the implementation and administration of this section.
(f)(1)(A) A health benefit plan that is offered, issued, or renewed in this state shall provide coverage for the use of intravenous immunoglobulin to treat individuals diagnosed with pediatric acute-onset neuropsychiatric syndrome or pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, or both, on or after January 1, 2024, if the pediatric patient's primary care physician, in consultation with an Arkansas licensed pediatric psychiatrist and an Arkansas licensed physician who practices in at least one (1) pediatric subspecialty, including a neurologist, rheumatologist, or infectious disease physician who has treated the pediatric patient determines and agrees that the treatment is necessary and follows a patient-specific treatment plan.
(B) A primary care physician may continue to consult with the Childhood Post-infectious Autoimmune Encephalopathy Center of Excellence.
(C) The appeal process for a denial of coverage or adverse determination under this subdivision (f)(1):
(i) Shall align with the normal appeal process of any other type of denial under the health benefit plan; and
(ii) Applies to all health benefit plans.
(2) Upon approval by the United States Food and Drug Administration of the use of intravenous immunoglobulin to treat individuals diagnosed with pediatric acute-onset neuropsychiatric syndrome or pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, or both, the Insurance Commissioner, with consultation and upon approval of the Arkansas State Medical Board and the Arkansas State Board of Pharmacy, shall adopt by rule a written statewide protocol that provides clarification that the consultation required under subdivision (f)(1) of this section and the patient-specific treatment plan required under subsection (c) of this section are no longer required for coverage under a health benefit plan.
(g) A primary care physician who prescribes intravenous immunoglobulin to treat individuals diagnosed with pediatric acute-onset neuropsychiatric syndrome or pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, or both, shall report the data to the Childhood Post-infectious Autoimmune Encephalopathy Center of Excellence.
Source: Arkansas General Assembly, Acts of 2021-2026 (arkleg.state.ar.us)URL: https://arkleg.state.ar.us/Acts/FTPDocument?path=%2FACTS%2F2023R%2FPublic%2F&file=876.pdf&ddBienniumSession=2023%2F2023RFetched: 11/8/2026