Section 2218.81 - DefinitionsAs used in this article, the terms defined below have the following meanings.
(a) "Coverage document" means a health insurance policy, evidence of coverage, certificate of coverage, schedule of benefits, or any other contract for health coverage.(b) "Dosage form" means the physical form in which a prescription drug is produced and dispensed, such as a tablet, a capsule, or an injectable.(c) "Established name" means the official, nonproprietary name for a drug, as defined in section 111225 of the Health and Safety Code, which must appear on the label pursuant to section 111355 of the Health and Safety Code.(d) "Exception request" means the process by which an insured requests and gains access to coverage for a clinically appropriate non-formulary drug pursuant to subdivision (i) of section 10123.191 of the Insurance Code.(e) "Exigent circumstances" means when an insured is suffering from a health condition that may seriously jeopardize the insured's life, health, or ability to regain maximum function, or when an insured is undergoing a current course of treatment using a non-formulary drug.(f) "Formulary" means the complete list of prescription drugs preferred for use and eligible for coverage under a health insurance product, and includes all drugs covered under the outpatient prescription drug benefit of the product.(g) "Health insurance" has the same meaning as defined in section 106 of the Insurance Code.(h) "Non-formulary drug" means any prescription drug for which an insured's copayment or out-of-pocket costs are different than the copayment for a formulary prescription drug, except as otherwise provided by law or regulation and when a prescription drug that is not listed on the formulary is covered pursuant to an exception request.(i) "Plan" means, with respect to a product, the pairing of the health benefits under a product with a particular cost sharing structure, provider network, and service area.(j) "Prescription drug" or "drug" means a drug, as that term is defined in section 109925 of the Health and Safety Code, which is limited to prescription use by law. As used in this article, the term "prescription drug" or "drug" also includes: (1) Disposable devices that are medically necessary for the administration of a covered prescription drug, such as spacers and inhalers for the administration of aerosol outpatient prescription drugs;(2) Syringes for self-injectable prescription drugs that are not dispensed in pre-filled syringes;(3) Drugs, devices, and FDA-approved products covered under the outpatient prescription drug benefit of the product pursuant to sections 10112.2, 10123.196, and 10176.61 of the Insurance Code, including any over-the-counter drugs, devices, and FDA-approved products that must be covered pursuant to those sections; and(4) At the option of a health insurer, any vaccines or other health benefits covered under the outpatient prescription drug benefit of the product.(k) "Product" means a discrete package of health benefits (including variable benefit choices offered within a package in the large group market) that a health insurer offers using a particular product network type, such as preferred provider organization, exclusive provider organization, point of service, or indemnity, within a service area.(l) "Quantity limit" means a restriction on the number of doses of a prescription drug covered by a health insurance product during a specific time period, or any other limitation on the quantity of a drug that is covered.(m) "Strength" means the amount of active ingredient or active ingredients that is present in each dose of a prescription drug.Cal. Code Regs. Tit. 10, § 2218.81
1. New section filed 8-31-2018; operative 10-1-2018 (Register 2018, No. 35).
2. Change without regulatory effect amending NOTE filed 8-18-2023 pursuant to section 100, title 1, California Code of Regulations (Register 2023, No. 33). Note: Authority cited: Section 10123.192, Insurance Code. Reference: Sections 106, 10112.2, 10112.27, 10123.191, 10123.192, 10123.193, 10123.1932, 10123.196, 10123.201 and 10176.61, Insurance Code.
1. New section filed 8-31-2018; operative 10/1/2018 (Register 2018, No. 35).
2. Change without regulatory effect amending NOTE filed 8-18-2023 pursuant to section 100, title 1, California Code of Regulations (Register 2023, No. 33).