Definitions

Section 2030.30  Definitions "Accident and health insurance" has the meaning ascribed in Section 4, Class 1(b) and 2(a) of the Code. "Biological product" has the meaning ascribed in Section 19.5 of the Pharmacy Practice Act [225 ILCS 85]. "Brand name drug" means a drug that has been approved under 21 U.S.C. 262 or 21 U.S.C. 355(c), as applicable, and is marketed, sold, or distributed under a proprietary, trademark-protected name. "CMS" means the Illinois Department of Central Management Services. "Code" means the Illinois Insurance Code [215 ILCS 5]. "Cost-sharing" means a copayment, coinsurance, or deductible that a health product requires a covered individual to pay for covered health care services. "Coverage document" means a policy, contract, evidence of coverage, certificate of coverage, schedule of benefits, outline of coverage, summary plan description, or any other policy form for a health product. "Covered individual" means an individual enrolled in, subscribed to, or insured under a health product, whether directly or as a dependent or beneficiary. "Department" means the Illinois Department of Insurance. "Director" means the Director of the Department. "Dosage form" is the physical form in which a drug is produced and dispensed, such as a tablet, a capsule, or an injectable. "Drug" has the meaning ascribed in Section 3 of the Pharmacy Practice Act and includes biological products. "Established name" has the meaning ascribed in Section 15(e)(2) of the Illinois Food, Drug and Cosmetic Act [410 ILCS 620]. "Exception request" is the process set forth in Section 45.1 of the Managed Care Reform and Patient Rights Act [215 ILCS 134] by which a covered individual requests and gains or renews access to clinically appropriate nonformulary drugs, clinically appropriate drugs being removed from the formulary, clinically appropriate quantities of a drug in excess of a quantity limit, or a drug that is clinically appropriate for the covered individual before a step therapy requirement otherwise would allow. "Exception request" also is any similar process that a health product not subject to Section 45.1 may make available to covered individuals. "Exigent circumstances" means circumstances when a covered individual is suffering from a health condition that may seriously jeopardize the covered individual's life, health, or ability to regain maximum function or when a covered individual is undergoing a current course of treatment using a nonformulary drug. "Exigent circumstances" includes "urgent medication needs" under Section 364.3 of the Code. "Formulary" means the complete list of drugs preferred for use and eligible for coverage under the outpatient or pharmacy drug benefit of a health product, regardless of whether the health product is a separate pharmaceutical policy or a policy that integrates drug benefits with other benefits for the diagnosis and treatment of the underlying health condition. "Formulary drug" means a drug listed on a health product's formulary, other than a nonformulary drug that a health insurance issuer has listed to provide additional information. "Generic drug" means a drug that has been approved under 21 U.S.C. 262 or 21 U.S.C. 355(c), as applicable, and is marketed, sold, or distributed directly or indirectly to the retail class of trade with labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trademark that differs from that of the brand name drug. "Health care plan" has the meaning ascribed in Section 1-2(7) of the Health Maintenance Organization Act [215 ILCS 125]. "Health insurance issuer" has the meaning ascribed in Section 5 of the Illinois Health Insurance Portability and Accountability Act [215 ILCS 97]. In this Part, "health insurance issuer" also includes CMS with respect to its State employee health plans. "Health product" means a discrete package of benefits for health care services under a particular policy, contract, certificate, or other evidence of coverage issued to covered individuals for any of the following: accident and health insurance, a health care plan, a limited health care plan, a voluntary health services plan, or a State employee health plan. "Limited health care plan" has the meaning ascribed in Section 1002 of the Limited Health Service Organization Act [215 ILCS 130]. "Nonformulary drug" means a drug for which a covered individual's cost-sharing or other out-of-pocket costs are different than the cost-sharing or other out-of-pocket costs for a formulary drug, except as otherwise provided by law or regulation. "Non-grandfathered health insurance coverage" means a health product other than a grandfathered health plan as defined in 42 U.S.C. 18011. "Out-of-pocket cost" means cost-sharing and all other costs for health care services that the health product does not cover for a covered individual. "Plain language" means "plain writing" as provided in the federal Plain Writing Act of 2010 (Pub. Law 111-274) and subsequent guidance documents, including the "Federal Plain Language Guidelines" published by the Plain Language Action and Information Network with support from the United States General Services Administration, 1800 F Street, NW, Washington, DC  20405 (rev. 1, May 2011) (no later editions or amendments), available online at: https://www.plainlanguage.gov/media/FederalPLGuidelines.pdf. "Plan" means, with respect to a health product, the pairing of the health benefits under a product with a particular cost-sharing structure, provider network, and service area. "Quantity limit" is a restriction on the number of doses or any other limitations on the quantity of a drug a health product will cover during a specific time period. "State employee health plan" means any coverage under the program of health benefits administered by CMS under the State Employees Group Insurance Act of 1971 [5 ILCS 375]. "Strength" is the amount of active ingredient or ingredients present in each dose of a drug. "Utilization review" has the meaning ascribed in Section 10 of the Managed Care Reform and Patient Rights Act. "Voluntary health services plan" has the meaning ascribed in Section 2 of the Voluntary Health Services Plans Act [215 ILCS 165].