Stricken language would be deleted from and underlined language would be added to present law. *ANS097* 04-03-2023 13:21:33 ANS097 State of Arkansas As Engrossed: S4/3/23 1 94th General Assembly A Bill 2 Regular Session, 2023 SENATE BILL 181 3 4 By: Senator K. Hammer 5 6 For An Act To Be Entitled 7 AN ACT TO MANDATE CO VERAGE FOR USE OF IN TRAVENOUS 8 IMMUNOGLOBULIN TO TR EAT PEDIATRIC ACUTE-ONSET 9 NEUROPSYCHIATRIC SYN DROME OR PEDIATRIC A UTOIMMUNE 10 NEUROPSYCHIATRIC DIS ORDERS ASSOCIATED WI TH 11 STREPTOCOCCAL INFECT ION; TO DECLARE AN E MERGENCY; AND 12 FOR OTHER PURPOSES. 13 14 15 Subtitle 16 TO MANDATE COVERAGE FOR USE OF 17 INTRAVENOUS IMMUNOGLOBULIN TO TREAT 18 CERTAIN PEDIATRIC DISORDERS CAUSED BY 19 INFECTIONS; AND TO DECLARE AN EMERGENCY. 20 21 22 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF ARKANSAS: 23 24 SECTION 1. Effective January 1, 2024, Arkansas Code § 23 -79-1903 is 25 repealed. 26 23-79-1903. Arkansas PANS/PANDAS Advisory Council — Creation — 27 Membership — Duties. 28 (a) There is created the Arkansas PANS/PANDAS Advisory Council to 29 consist of the following members: 30 (1) Two (2) members of the House of Representatives appointed by 31 the Speaker of the House of Representatives; 32 (2) Two (2) members of the Senate appointed by the President Pro 33 Tempore of the Senate; 34 (3) One (1) member who is a medical professional with two (2) 35 years of professional experience working with PANS/PANDAS patients, appointed 36 As Engrossed: S4/3/23 SB181 2 04-03-2023 13:21:33 ANS097 by the Governor; 1 (4) One (1) member who is a medical professional with two (2) 2 years of professional experience working with PANS/PANDAS patients, appointed 3 by the council; 4 (5) The Secretary of the Department of Health or his or her 5 designee, serving as an ex officio nonvoting member; 6 (6) The Insurance Commissioner or his or her designee, serving 7 as an ex officio nonvoting member; 8 (7) Three (3) members appointed by the Governor who are employed 9 by a public school district, one (1) member to be a public school nurse, one 10 (1) member to be a public school counselor, and one (1) member to be a public 11 school teacher; 12 (8) One (1) member who is designated by the Arkansas Hospital 13 Association, Inc.; 14 (9) One (1) member who is designated by the Arkansas State Board 15 of Nursing; 16 (10) One (1) member who is designated by the Arkansas 17 Pharmacist's Association; 18 (11) One (1) member who is designated by the American Academy of 19 Allergy, Asthma, and Immunology; 20 (12) Two (2) members who are parents, appointed by the Governor; 21 and 22 (13) One (1) member who is designated by the Arkansas Medical, 23 Dental, and Pharmaceutical Association, Inc. 24 (b)(1) Upon appointment to the council, the initial members shall draw 25 lots to determine the length of their terms. 26 (2) Appointments shall be for a term of four (4) years. 27 (3) Vacancies on the council shall be filled in the same manner 28 as provided for the initial appointment. 29 (4) The new appointee shall serve for the remainder of the 30 unexpired term. 31 (c) Members shall serve at the pleasure of the organizations they 32 represent or of the Governor, as indicated. 33 (d)(1) The President Pro Tempore of the Senate shall appoint the Chair 34 of the Arkansas PANS/PANDAS Advisory Council who shall be one (1) of the 35 legislative members of the council. 36 As Engrossed: S4/3/23 SB181 3 04-03-2023 13:21:33 ANS097 (2) The Speaker of the House of Representatives shall appoint 1 the Vice Chair of the Arkansas PANS/PANDAS Advisory Council who shall be one 2 (1) of the legislative members of the council. 3 (e)(1) A majority of the membership shall constitute a quorum. 4 (2) A majority vote of those members present shall be required 5 for any action of the council. 6 (f)(1) The council shall meet as often as is deemed necessary by the 7 chair. 8 (2) The council shall meet at the State Capitol Building in 9 Little Rock, Arkansas. 10 (g) Legislators shall be paid per diem and mileage as authorized by 11 law for attendance at meetings of interim committees of the General Assembly. 12 (h)(1) The council shall receive staff support from the Bureau of 13 Legislative Research. 14 (2) The council shall receive assistance from the Children's 15 Postinfectious Autoimmune Encephalopathy Center of Excellence at the 16 University of Arizona Steele Children's Research Center with the preparation 17 of any reports required by this subchapter. 18 (i) The council may: 19 (1) Make recommendations designed to improve and increase 20 knowledge and develop mechanisms to increase clinical awareness and treatment 21 throughout the state for pediatric acute-onset neuropsychiatric syndrome, 22 also known as “PANS”, and pediatric autoimmune neuropsychiatric disorders 23 associated with streptococcal infections, also known as “PANDAS”, especially 24 for healthcare professionals; 25 (2) Operate along with the interdisciplinary panel on 26 PANS/PANDAS at the University of Arkansas for Medical Sciences to determine 27 quarterly information, including case statistics, outcome measures, and other 28 relevant information; 29 (3) Make recommendations concerning standard practice guidelines 30 for the diagnosis and treatment of PANS/PANDAS for adult and pediatric 31 patients who have been diagnosed with PANS/PANDAS; 32 (4) Provide outreach to educators and parents; 33 (5) Develop a network of volunteer experts on PANS/PANDAS to 34 serve as resources within this state; and 35 (6) Consider any related topics associated with the council's 36 As Engrossed: S4/3/23 SB181 4 04-03-2023 13:21:33 ANS097 charge. 1 (j)(1) The council shall report to the Senate Committee on Insurance 2 and Commerce, the House Committee on Insurance and Commerce, the Senate 3 Committee on Public Health, Welfare, and Labor, and the House Committee on 4 Public Health, Welfare, and Labor, as requested. 5 (2) The report described in subdivision (j)(1) of this section 6 shall be submitted to the Legislative Council for final review. 7 8 SECTION 2. Arkansas Code § 23 -79-1904 is repealed. 9 23-79-1904. Sunset. 10 This subchapter shall expire on December 31, 2023, unless extended by 11 the General Assembly. 12 13 SECTION 3. Arkansas Code § 23 -79-1905 is amended to read as follows: 14 23-79-1905. Off-label use and coverage of drug treatment to treat 15 pediatric acute-onset neuropsychiatric syndrome and pediatric autoimmune 16 neuropsychiatric disorders associated with streptococcal infection — 17 Legislative findings — Definitions. 18 (a) The General Assembly finds that: 19 (1) Pediatric acute-onset neuropsychiatric syndrome, also known 20 as “PANS”, is a clinically defined disorder characterized by the sudden onset 21 of obsessive-compulsive symptoms or eating restrictions, accompanied by two 22 (2) or more symptoms of acute behavioral deter ioration or motor and sensory 23 changes, or both; 24 (2) Pediatric autoimmune neuropsychiatric disorders associated 25 with streptococcal infection, also known as “PANDAS”, is a term used to 26 describe a subset of symptoms affecting children and adolescents withi n the 27 broader PANS classification; 28 (3) Other states may require coverage for off -label use of drug 29 treatments to treat pediatric acute -onset neuropsychiatric syndrome and 30 pediatric autoimmune neuropsychiatric disorders associated with streptococcal 31 infection; and 32 (4) Arkansas does not require coverage for off -label use of drug 33 treatments to treat patients who are diagnosed with pediatric acute -onset 34 neuropsychiatric syndrome and pediatric autoimmune neuropsychiatric disorders 35 associated with streptoco ccal infections. 36 As Engrossed: S4/3/23 SB181 5 04-03-2023 13:21:33 ANS097 (b) As used in this section: 1 (1)(A) “Health benefit plan” means an individual, blanket, or 2 any group plan, policy, or contract for healthcare services issued, renewed, 3 or extended in this state by a healthcare insurer, health maintenance 4 organization, hospital medical service corporation, or self -insured 5 governmental or church plan in this state. 6 (B) “Health benefit plan” includes: 7 (i) A plan offered by a risk -based provider 8 organization as established under the Medica id Provider-Led Organized Care 9 Act, § 20-77-2701 et seq.; 10 (ii) Indemnity and managed care plans; and 11 (iii) Plans providing health benefits to state and 12 public school employees under § 21 -5-401 et seq. 13 (C) “Health benefit plan” does not includ e: 14 (i) A plan that provides only dental benefits or eye 15 and vision care benefits; 16 (ii) A disability income plan; 17 (iii) A credit insurance plan; 18 (iv) Insurance coverage issued as a supplement to 19 liability insurance; 20 (v) Medical payments under an automobile or 21 homeowners insurance plan; 22 (vi) A health benefit plan provided under Arkansas 23 Constitution, Article 5, § 32, the Workers' Compensation Law, § 11 -9-101 et 24 seq., and the Public Employee Workers' Compensation Act, § 21 -5-601 et seq.; 25 (vii) A plan that provides only indemnity for 26 hospital confinement; 27 (viii) An accident-only plan; or 28 (ix) A specified disease plan; and 29 (2)(A) “Healthcare insurer” means any insurance company, 30 hospital and medical service corporat ion, or health maintenance organization 31 that issues or delivers health benefit plans in this state and is subject to 32 any of the following laws: 33 (i) The insurance laws of this state; 34 (ii) Section 23-75-101 et seq., pertaining to 35 hospital and medical service corporations; 36 As Engrossed: S4/3/23 SB181 6 04-03-2023 13:21:33 ANS097 (iii) Section 23-76-101 et seq., pertaining to 1 health maintenance organizations; or 2 (iv) A risk-based provider organization established 3 under the Medicaid Provider -Led Organized Care Act, § 20 -77-2701 et seq. 4 (B) “Healthcare insurer” does not include an entity that 5 provides only dental benefits or eye and vision care benefits. 6 (c)(1) A Except as provided in subsection (f) of this section, a 7 health benefit plan that is offered, issued, or renewed in this state, 8 including a plan offered by a risk -based provider organization established 9 under the Medicaid Provider -Led Organized Care Act, § 20 -77-2701 et seq., 10 shall provide coverage for off -label use of intravenous immunoglobulin, also 11 known as “IVIG”, to treat individual s diagnosed with pediatric acute -onset 12 neuropsychiatric syndrome or pediatric autoimmune neuropsychiatric disorders 13 associated with streptococcal infection, or both, on or after January 1, 14 2022, under a patient -specific treatment plan established by the Ch ildhood 15 Post-infectious Autoimmune Encephalopathy Clinic established by the 16 University of Arkansas for Medical Sciences in collaboration with Arkansas 17 Children's Hospital consistent with established protocols and rules to be 18 developed by the Insurance Comm issioner, in consultation with the Childhood 19 Post-infectious Autoimmune Encephalopathy Center of Excellence. 20 (2) Rules to implement this subdivision have to be promulgated 21 by August 31, 2023. 22 (d) The coverage for off-label use of drug treatment to treat 23 pediatric acute-onset neuropsychiatric syndrome and pediatric autoimmune 24 neuropsychiatric disorders associated with streptococcal infection under this 25 section: 26 (1) May be subject to policy deductions or copayment 27 requirements and any standard prior authorization review of a healthcare 28 insurer or a health benefit plan; and 29 (2) Does not diminish or limit benefits otherwise allowable 30 under a health benefit plan. 31 (e) The Insurance Commissioner shall develop and promulgate rules for 32 the implementation and administration of this section. 33 (f)(1)(A) A health benefit plan that is offered, issued, or renewed in 34 this state shall provide coverage for the use of intravenous immunoglobulin 35 to treat individuals diagnosed with pediatric acute-onset neuropsychiatric 36 As Engrossed: S4/3/23 SB181 7 04-03-2023 13:21:33 ANS097 syndrome or pediatric autoimmune neuropsychiatric disorders associated with 1 streptococcal infection, or both, on or after January 1, 2024, if the 2 pediatric patient's primary care physician, in consultation with an Arkansas 3 licensed pediatric psychiatrist and an Arkansas licensed physician who 4 practices in at least one (1) pediatric subspecialty, including a 5 neurologist, rheumatologist, or infectious disease physician who has treated 6 the pediatric patient determines and agrees that the treatment is necessary 7 and follows a patient-specific treatment plan. 8 (B) A primary care physician may continue to consult with 9 the Childhood Post-infectious Autoimmune Encephalopathy Center of Excellence. 10 (C) The appeal process for a denial of coverage or adverse 11 determination under this subdivision (f)(1): 12 (i) Shall align with the normal appeal process of 13 any other type of denial under the health benefit plan; and 14 (ii) Applies to all health benefit plans. 15 (2) Upon approval by the United States Food and Drug 16 Administration of the use of intravenous immunoglobulin to treat individuals 17 diagnosed with pediatric acute-onset neuropsychiatric syndrome or pediatric 18 autoimmune neuropsychiatric disorders associated with streptococcal 19 infection, or both, the Insurance Commissioner, with consultation and upon 20 approval of the Arkansas State Medical Board and the Arkansas State Board of 21 Pharmacy, shall adopt by rule a written statewide protocol that provides 22 clarification that the consultation required under subdivision (f)(1) of this 23 section and the patient-specific treatment plan required under subsection (c) 24 of this section are no longer required for coverage under a health benefit 25 plan. 26 (g) A primary care physician who prescribes intravenous immunoglobulin 27 to treat individuals diagnosed with pediatric acute-onset neuropsychiatric 28 syndrome or pediatric autoimmune neuropsychiatric disorders associated with 29 streptococcal infection, or both, shall report the data to the Childhood 30 Post-infectious Autoimmune Encephalopathy Center of Excellence. 31 32 SECTION 4. EMERGENCY CLAUSE. It is found and determined by the 33 General Assembly of the State of Arkansas that certain children in this state 34 who are diagnosed with pediatric acute-onset neuropsychiatric syndrome or 35 pediatric autoimmune neuropsychiatric disorders associated with streptococcal 36 As Engrossed: S4/3/23 SB181 8 04-03-2023 13:21:33 ANS097 infection, or both, are receiving limited treatment options; that requiring 1 healthcare insurers to provide coverage of intravenous immunoglobulin, also 2 known as “IVIG”, to treat individuals diagnosed with pediatric acute-onset 3 neuropsychiatric syndrome or pediatric autoimmune neuropsychiatric disorders 4 associated with streptococcal infection, or both, could alleviate some 5 symptoms; and that this act is immedi ately necessary to ensure that children 6 receive the greatest chance to be healthy and live productive lives. 7 Therefore, an emergency is declared to exist, and this act being immediately 8 necessary for the preservation of the public peace, health, and safety shall 9 become effective on: 10 (1) The date of its approval by the Governor; 11 (2) If the bill is neither approved nor vetoed by the Governor, 12 the expiration of the period of time during which the Governor may veto the 13 bill; or 14 (3) If the bill is vet oed by the Governor and the veto is 15 overridden, the date the last house overrides the veto. 16 17 SECTION 5. TEMPORARY LANGUAGE. DO NOT CODIFY. Rules. 18 (a) The Insurance Commissioner, in consultation with the Staff of the 19 Childhood Post-infectious Autoimmune Encephalopathy Center of Excellence, 20 shall promulgate rules necessary to implement Section 3 of this act. 21 (b)(1) When adopting the initial rules to implement this act, the 22 final rule shall be filed with the Secretary of State for adoption under § 23 25-15-204(f): 24 (A) On or before August 31, 2023; or 25 (B) If approval under § 10-3-309 has not occurred by 26 August 31, 2023, as soon as practicable after approval under § 10-3-309. 27 (2) The commissioner shall file the proposed rule with the 28 Legislative Council under § 10-3-309(c) sufficiently in advance of August 31, 29 2023, so that the Legislative Council may consider the rule for approval 30 before August 31, 2023. 31 32 /s/K. Hammer 33 34 35 36