Arkansas Administrative Code › Agency 003 - DEPARTMENT OF COMMERCE › Division 22 - Insurance Department › Rule 003.22.21-006 - Regulation of Medication Step Therapy Protocals

Current through Register Vol. 49, No. 6, June, 2024
SECTION 1.
PURPOSE
This Rule implements Act 97 of 2021 and Act 645 of 2021, which
				amends a definition within Act 97. Act 97 requires healthcare insurers to base
				medication step therapy protocols on appropriate clinical practice guidelines
				or peer-reviewed data developed by independent experts with knowledge of the
				condition or conditions under consideration. Act 97 also ensures that patients
				have access to a fair, transparent, and independent process for requesting a
				step therapy protocol exception when the patient's physician deems it
				appropriate.
SECTION 2.
AUTHORITY
This Rule is issued pursuant to the authority granted the
				Arkansas Insurance Commissioner ("Commissioner") by Act 97 of 2021, codified at
				Ark. Code Ann. § 23-79-2101 et seq., which provides the Commissioner with
				authority necessary to promulgate rules to implement Section 7 of Act 97 of
				2021.
SECTION 3.
APPLICABILITY
This subchapter applies to a group health benefit plan or
				health insurance coverage offered in connection with a group health plan that
				provides coverage of a prescription drug under a policy that meets the
				definition of a medication step therapy protocol whether or not the policy is
				described as a step therapy protocol.
SECTION 4.
DEFINITIONS
(1) "Clinical practice guidelines" means a
			 systematically developed statement derived from peer-reviewed published medical
			 literature, evidence-based research, and widely accepted medical practice to
			 assist decision-making by healthcare providers and patients about appropriate
			 healthcare for specific clinical circumstances and conditions.
(2) "Clinical review criteria" means the
			 written screening procedures, decision abstracts, clinical protocols, and
			 clinical practice guidelines used by a healthcare insurer, health benefit plan,
			 or utilization review organization to determine the medical necessity and
			 appropriateness of healthcare services.
(3) "Generic equivalent" means a drug rated
			 "A" or "B" by the United States Preventive Taskforce that is pharmaceutically
			 and therapeutically equivalent to the drug prescribed.
(4)
(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:
(1) Indemnity and managed care
			 plans;
(2) Plans providing health
			 benefits to state and public school employees under Ark. Code Ann. §
											21-5-401
			 et seq.; and
(3) Individual
			 qualified health insurance plans under Ark. Code Ann. §
											23-61-1001
			 et seq.
(c) "Health
			 benefit plan" does not include:
(1) A
			 disability income plan;
(2) A
			 credit insurance plan;
(3)
			 Insurance coverage issued as a supplement to liability insurance;
(4) Medical payments under an automobile or
			 homeowner insurance plan;
(5) A
			 health benefit plan provided under Arkansas Constitution, Article 5, § 32,
			 the Workers' Compensation Law, Ark. Code Ann. §
											11-9-101 et seq.,
			 and the Public Employee Workers' Compensation Act, Ark. Code Ann. §
											21-5-601 et
			 seq.;
(6) A plan that provides only
			 indemnity for hospital confinement;
(7) An accident-only plan;
(8) A specified disease plan;
(9) A plan that provides only dental benefits
			 or eye and vision care benefits; or
(10) A program or plan authorized under
			 42 U.S.C. §
												1396a et seq., as it existed on January 1,
			 2021, as approved by the United States Secretary of Health and Human Services,
			 excluding individual qualified health plans under Ark. Code Ann. §
											23-61-1001
			 et seq.
(5)
(a) "Healthcare insurer" means an insurance
			 company, a hospital medical service corporation, or a health maintenance
			 organization that issues or delivers health benefit plans in this state and is
			 subject to any of the following laws:
(1) The
			 insurance laws of this state;
(2)
			 Ark. Code Aim. §
											23-75-101
			 et seq., pertaining to hospital and medical service corporations; or
(3) Ark. Code Aim. §
											23-76-101 et
			 seq., pertaining to health maintenance organizations.
(b) "Healthcare insurer" does not include an
			 entity that provides only dental benefits or eye and vision care
			 benefits.
(6)
			 "Interchangeable biological product" means a biological product that is
			 interchangeable, as "interchangeable" is defined by
			 42 U.S.C. §
										262(i)(3), as it existed on
			 January 1, 2021.
(7) "Medically
			 necessary" means healthcare services and supplies that, under the applicable
			 standard of care, are appropriate:
(a) To
			 improve or preserve health, life, or function;
(b) To slow the deterioration of health,
			 life, or function; or
(c) For the
			 early screening, prevention, evaluation, diagnosis, or treatment of a disease,
			 condition, illness, or injury.
(8) "Step therapy protocol" means a protocol,
			 policy, or program that establishes the specific sequence in which prescription
			 drugs for a specified medical condition that are medically appropriate for a
			 patient are covered by a healthcare insurer or health benefit plan.
(9) "Step therapy protocol exception" means
			 that a step therapy protocol is overridden in favor of immediate coverage of
			 the healthcare provider's selected prescription drug.
(10)
(a)
			 "Utilization review organization" means an individual or entity that performs
			 step therapy for at least one (1) of the following:
(1) A healthcare insurer;
(2) A preferred provider organization or
			 health maintenance organization; or
(3) Any other individual or entity that
			 provides, offers to provide, or administers hospital, outpatient, medical, or
			 other health benefits to a person treated by a healthcare provider in this
			 state under a policy, health benefit plan, or contract.
(b) A healthcare insurer is a utilization
			 review entity if the healthcare insurer performs step therapy.
(c) "Utilization review organization" does
			 not include an insurer of automobile, homeowner, or casualty and commercial
			 liability insurance or the insurer's employees, agents, or
			 contractors.