Stricken language would be deleted from and underlined language would be added to present law. Act 876 of the Regular Session *ANS097* 04-05-2023 14:59:58 ANS097 State of Arkansas As Engrossed: S4/3/23 H4/5/23 1 94th General Assembly A Bill 2 Regular Session, 2023 SENATE BILL 181 3 4 By: Senator K. Hammer 5 By: Representative Warren 6 7 For An Act To Be Entitled 8 AN ACT TO MANDATE CO VERAGE FOR USE OF IN TRAVENOUS 9 IMMUNOGLOBULIN TO TR EAT PEDIATRIC ACUTE-ONSET 10 NEUROPSYCHIATRIC SYN DROME OR PEDIATRIC A UTOIMMUNE 11 NEUROPSYCHIATRIC DIS ORDERS ASSOCIATED WI TH 12 STREPTOCOCCAL INFECT ION; TO DECLARE AN E MERGENCY; AND 13 FOR OTHER PURPOSES. 14 15 16 Subtitle 17 TO MANDATE COVERAGE FOR USE OF 18 INTRAVENOUS IMMUNOGLOBULIN TO TREAT 19 CERTAIN PEDIATRIC DISORDERS CAUSED BY 20 INFECTIONS; AND TO DECLARE AN EMERGENCY. 21 22 23 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF ARKANSAS: 24 25 SECTION 1. Effective January 1, 2024, Arkansas Code § 23 -79-1903 is 26 repealed. 27 23-79-1903. Arkansas PANS/PANDAS Advisory Council — Creation — 28 Membership — Duties. 29 (a) There is created the Arkansas PANS/PANDAS Advisory Council to 30 consist of the following members: 31 (1) Two (2) members of the House of Representatives appointed by 32 the Speaker of the House of Representatives; 33 (2) Two (2) members of the Senate appointed by the President Pro 34 Tempore of the Senate; 35 (3) One (1) member who is a medical professional with two (2) 36 As Engrossed: S4/3/23 H4/5/23 SB181 2 04-05-2023 14:59:58 ANS097 years of professional experience working with PANS/PANDAS patients, appointed 1 by the Governor; 2 (4) One (1) member who is a medical professional with two (2) 3 years of professional experience working with PANS/PANDAS patients, appointed 4 by the council; 5 (5) The Secretary of the Department of Health or his or her 6 designee, serving as an ex officio nonvoting member; 7 (6) The Insurance Commissioner or his or her designee, serving 8 as an ex officio nonvoting member; 9 (7) Three (3) members appointed by the Governor who are employed 10 by a public school district, one (1) member to be a public school nurse, one 11 (1) member to be a public school counselor, and one (1) member to be a public 12 school teacher; 13 (8) One (1) member who is designated by the Arkansas Hospital 14 Association, Inc.; 15 (9) One (1) member who is designated by the Arkansas State Board 16 of Nursing; 17 (10) One (1) member who is designated by the Arkansas 18 Pharmacist's Association; 19 (11) One (1) member who is designated by the American Academy of 20 Allergy, Asthma, and Immunology; 21 (12) Two (2) members who are parents, appointed by the Governor; 22 and 23 (13) One (1) member who is designated by the Arkansas Medical, 24 Dental, and Pharmaceutical Association, Inc. 25 (b)(1) Upon appointment to the council, the initial members shall draw 26 lots to determine the length of their terms. 27 (2) Appointments shall be for a term of four (4) years. 28 (3) Vacancies on the council shall be filled in the same manner 29 as provided for the initial appointment. 30 (4) The new appointee shall serve for the remainder of the 31 unexpired term. 32 (c) Members shall serve at the pleasure of the organizations they 33 represent or of the Governor, as indicated. 34 (d)(1) The President Pro Tempore of the Senate shall appoint the Chair 35 of the Arkansas PANS/PANDAS Advisory Council who shall be one (1) of the 36 As Engrossed: S4/3/23 H4/5/23 SB181 3 04-05-2023 14:59:58 ANS097 legislative members of the council. 1 (2) The Speaker of the House of Representatives shall appoint 2 the Vice Chair of the Arkansas PANS/PANDAS Advisory Council who shall be one 3 (1) of the legislative members of the council. 4 (e)(1) A majority of the membership shall constitute a quorum. 5 (2) A majority vote of those members present shall be required 6 for any action of the council. 7 (f)(1) The council shall meet as often as is deemed necessary by the 8 chair. 9 (2) The council shall meet at the State Capitol Building in 10 Little Rock, Arkansas. 11 (g) Legislators shall be paid per diem and mileage as authorized by 12 law for attendance at meetings of interim committees of the General Assembly. 13 (h)(1) The council shall receive staff support from the Bureau of 14 Legislative Research. 15 (2) The council shall receive assistance from the Children's 16 Postinfectious Autoimmune Encephalopathy Center of Excellence at the 17 University of Arizona Steele Children's Research Center with the preparation 18 of any reports required by this subchapter. 19 (i) The council may: 20 (1) Make recommendations designed to improve and increase 21 knowledge and develop mechanisms to increase clinical awareness and treatment 22 throughout the state for pediatric acute-onset neuropsychiatric syndrome, 23 also known as “PANS”, and pediatric autoimmune neuropsychiatric disorders 24 associated with streptococcal infections, also known as “PANDAS”, especially 25 for healthcare professionals; 26 (2) Operate along with the interdisciplinary panel on 27 PANS/PANDAS at the University of Arkansas for Medical Sciences to determine 28 quarterly information, including case statistics, outcome measures, and other 29 relevant information; 30 (3) Make recommendations concerning standard practice guidelines 31 for the diagnosis and treatment of PANS/PANDAS for adult and pediatric 32 patients who have been diagnosed with PANS/PANDAS; 33 (4) Provide outreach to educators and parents; 34 (5) Develop a network of volunteer experts on PANS/PANDAS to 35 serve as resources within this state; and 36 As Engrossed: S4/3/23 H4/5/23 SB181 4 04-05-2023 14:59:58 ANS097 (6) Consider any related topics associated with the council's 1 charge. 2 (j)(1) The council shall report to the Senate Committee on Insurance 3 and Commerce, the House Committee on Insurance and Commerce, the Senate 4 Committee on Public Health, Welfare, and Labor, and the House Committee on 5 Public Health, Welfare, and Labor, as requested. 6 (2) The report described in subdivision (j)(1) of this section 7 shall be submitted to the Legislative Council for final review. 8 9 SECTION 2. Arkansas Code § 23 -79-1904 is repealed. 10 23-79-1904. Sunset. 11 This subchapter shall expire on December 31, 2023, unless extended by 12 the General Assembly. 13 14 SECTION 3. Arkansas Code § 23 -79-1905 is amended to read as follows: 15 23-79-1905. Off-label use and coverage of drug treatment to treat 16 pediatric acute-onset neuropsychiatric syndrome and pediatric autoimmune 17 neuropsychiatric disorders associated with streptococcal infection — 18 Legislative findings — Definitions. 19 (a) The General Assembly finds that: 20 (1) Pediatric acute -onset neuropsychiatric syndrome, also known 21 as “PANS”, is a clinically defined disorder characterized by the sudden onset 22 of obsessive-compulsive symptoms or eating restrictions, accom panied by two 23 (2) or more symptoms of acute behavioral deterioration or motor and sensory 24 changes, or both; 25 (2) Pediatric autoimmune neuropsychiatric disorders associated 26 with streptococcal infection, also known as “PANDAS”, is a term used to 27 describe a subset of symptoms affecting children and adolescents within the 28 broader PANS classification; 29 (3) Other states may require coverage for off -label use of drug 30 treatments to treat pediatric acute -onset neuropsychiatric syndrome and 31 pediatric autoimmune n europsychiatric disorders associated with streptococcal 32 infection; and 33 (4) Arkansas does not require coverage for off -label use of drug 34 treatments to treat patients who are diagnosed with pediatric acute -onset 35 neuropsychiatric syndrome and pediatric aut oimmune neuropsychiatric disorders 36 As Engrossed: S4/3/23 H4/5/23 SB181 5 04-05-2023 14:59:58 ANS097 associated with streptococcal infections. 1 (b) As used in this section: 2 (1)(A) “Health benefit plan” means an individual, blanket, or 3 any group plan, policy, or contract for healthcare services issued, renewed, 4 or extended in this state by a healthcare insurer, health maintenance 5 organization, hospital medical service corporation, or self -insured 6 governmental or church plan in this state. 7 (B) “Health benefit plan” includes: 8 (i) A plan offered by a risk -based provider 9 organization as established under the Medicaid Provider -Led Organized Care 10 Act, § 20-77-2701 et seq.; 11 (ii) Indemnity and managed care plans; and 12 (iii) Plans providing health benefits to state and 13 public school employees under § 21 -5-401 et seq. 14 (C) “Health benefit plan” does not include: 15 (i) A plan that provides only dental benefits or eye 16 and vision care benefits; 17 (ii) A disability income plan; 18 (iii) A credit insurance plan; 19 (iv) Insurance coverage issued as a s upplement to 20 liability insurance; 21 (v) Medical payments under an automobile or 22 homeowners insurance plan; 23 (vi) A health benefit plan provided under Arkansas 24 Constitution, Article 5, § 32, the Workers' Compensation Law, § 11 -9-101 et 25 seq., and the Public Employee Workers' Compensation Act, § 21 -5-601 et seq.; 26 (vii) A plan that provides only indemnity for 27 hospital confinement; 28 (viii) An accident-only plan; or 29 (ix) A specified disease plan; and 30 (2)(A) “Healthcare insurer” means any i nsurance company, 31 hospital and medical service corporation, or health maintenance organization 32 that issues or delivers health benefit plans in this state and is subject to 33 any of the following laws: 34 (i) The insurance laws of this state; 35 (ii) Section 23-75-101 et seq., pertaining to 36 As Engrossed: S4/3/23 H4/5/23 SB181 6 04-05-2023 14:59:58 ANS097 hospital and medical service corporations; 1 (iii) Section 23-76-101 et seq., pertaining to 2 health maintenance organizations; or 3 (iv) A risk-based provider organization established 4 under the Medicaid Provider -Led Organized Care Act, § 20 -77-2701 et seq. 5 (B) “Healthcare insurer” does not include an entity that 6 provides only dental benefits or eye and vision care benefits. 7 (c)(1) A Except as provided in subsection (f) of this section, a 8 health benefit plan th at is offered, issued, or renewed in this state, 9 including a plan offered by a risk -based provider organization established 10 under the Medicaid Provider -Led Organized Care Act, § 20 -77-2701 et seq., 11 shall provide coverage for off -label use of intravenous im munoglobulin, also 12 known as “IVIG”, to treat individuals diagnosed with pediatric acute -onset 13 neuropsychiatric syndrome or pediatric autoimmune neuropsychiatric disorders 14 associated with streptococcal infection, or both, on or after January 1, 15 2022, under a patient-specific treatment plan established by the Childhood 16 Post-infectious Autoimmune Encephalopathy Clinic established by the 17 University of Arkansas for Medical Sciences in collaboration with Arkansas 18 Children's Hospital consistent with established pr otocols and rules to be 19 developed by the Insurance Commissioner, in consultation with the Childhood 20 Post-infectious Autoimmune Encephalopathy Center of Excellence. 21 (2) Rules to implement this subdivision have to be promulgated 22 by August 31, 2023. 23 (d) The coverage for off-label use of drug treatment to treat 24 pediatric acute-onset neuropsychiatric syndrome and pediatric autoimmune 25 neuropsychiatric disorders associated with streptococcal infection under this 26 section: 27 (1) May be subject to policy d eductions or copayment 28 requirements and any standard prior authorization review of a healthcare 29 insurer or a health benefit plan; and 30 (2) Does not diminish or limit benefits otherwise allowable 31 under a health benefit plan. 32 (e) The Insurance Commission er shall develop and promulgate rules for 33 the implementation and administration of this section. 34 (f)(1)(A) A health benefit plan that is offered, issued, or renewed in 35 this state shall provide coverage for the use of intravenous immunoglobulin 36 As Engrossed: S4/3/23 H4/5/23 SB181 7 04-05-2023 14:59:58 ANS097 to treat individuals diagnosed with pediatric acute-onset neuropsychiatric 1 syndrome or pediatric autoimmune neuropsychiatric disorders associated with 2 streptococcal infection, or both, on or after January 1, 2024, if the 3 pediatric patient's primary care physician, in consultation with an Arkansas 4 licensed pediatric psychiatrist and an Arkansas licensed physician who 5 practices in at least one (1) pediatric subspecialty, including a 6 neurologist, rheumatologist, or infectious disease physician who has treated 7 the pediatric patient determines and agrees that the treatment is necessary 8 and follows a patient-specific treatment plan. 9 (B) A primary care physician may continue to consult with 10 the Childhood Post-infectious Autoimmune Encephalopathy Center of Excellence. 11 (C) The appeal process for a denial of coverage or adverse 12 determination under this subdivision (f)(1): 13 (i) Shall align with the normal appeal process of 14 any other type of denial under the health benefit plan; and 15 (ii) Applies to all health benefit plans. 16 (2) Upon approval by the United States Food and Drug 17 Administration of the use of intravenous immunoglobulin to treat individuals 18 diagnosed with pediatric acute-onset neuropsychiatric syndrome or pediatric 19 autoimmune neuropsychiatric disorders associated with streptococcal 20 infection, or both, the Insurance Commissioner, with consultation and upon 21 approval of the Arkansas State Medical Board and the Arkansas State Board of 22 Pharmacy, shall adopt by rule a written statewide protocol that provides 23 clarification that the consultation required under subdivision (f)(1) of this 24 section and the patient-specific treatment plan required under subsection (c) 25 of this section are no longer required for coverage under a health benefit 26 plan. 27 (g) A primary care physician who prescribes intravenous immunoglobulin 28 to treat individuals diagnosed with pediatric acute-onset neuropsychiatric 29 syndrome or pediatric autoimmune neuropsychiatric disorders associated with 30 streptococcal infection, or both, shall report the data to the Childhood 31 Post-infectious Autoimmune Encephalopathy Center of Excellence. 32 33 SECTION 4. EMERGENCY CLAUSE. It is found and determined by the 34 General Assembly of the State of Arkansas that certain children in this state 35 who are diagnosed with pediatric acute-onset neuropsychiatric syndrome or 36 As Engrossed: S4/3/23 H4/5/23 SB181 8 04-05-2023 14:59:58 ANS097 pediatric autoimmune neuropsychiatric disorders associated with streptococcal 1 infection, or both, are receiving limited treatment options; that requiring 2 healthcare insurers to provide coverage of intravenous immunoglobulin, also 3 known as “IVIG”, to treat individuals diagnosed with pediatric acute-onset 4 neuropsychiatric syndrome or pediatric autoimmune neuropsychiatric disorders 5 associated with streptococcal infection, or both, could alleviate some 6 symptoms; and that this act is immediately necessary to ensure that children 7 receive the greatest chance to be healthy and live productive lives. 8 Therefore, an emergency is declared to exist, and this act being immediately 9 necessary for the preservation of the public peace, health, and safety shall 10 become effective on: 11 (1) The date of its approval by the Governor; 12 (2) If the bill is neither approved nor vetoed by the Governor, 13 the expiration of the period of time during which the Governor may veto th e 14 bill; or 15 (3) If the bill is vetoed by the Governor and the veto is 16 overridden, the date the last house overrides the veto. 17 18 SECTION 5. TEMPORARY LANGUAGE. DO NOT CODIFY. Rules. 19 (a) The Insurance Commissioner, in consultation with the Staff of the 20 Childhood Post-infectious Autoimmune Encephalopathy Center of Excellence, 21 shall promulgate rules necessary to implement Section 3 of this act. 22 (b)(1) When adopting the initial rules to implement this act, the 23 final rule shall be filed with the Secretary of State for adoption under § 24 25-15-204(f): 25 (A) On or before August 31, 2023; or 26 (B) If approval under § 10-3-309 has not occurred by 27 August 31, 2023, as soon as practicable after approval under § 10-3-309. 28 (2) The commissioner shall file the proposed rule with the 29 Legislative Council under § 10-3-309(c) sufficiently in advance of August 31, 30 2023, so that the Legislative Council may consider the rule for approval 31 before August 31, 2023. 32 33 /s/K. Hammer 34 APPROVED: 4/13/23 35 36