California Code of Regulations › Title 28 - Managed Health Care › Division 1 - The Department of Managed Health Care › Chapter 2 - Health Care Service Plans › Article 7 - Standards › Section 1300.67.205 - Standard Prescription Drug Formulary Template

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The following standards are minimum standards, and unless
					 otherwise noted, apply to all health plan formularies subject to section
					 1367.205
					 of the Health and Safety Code. A health plan may implement additional
					 provisions exceeding these requirements.
(a) Definitions.
(1) "Coverage document" is a health plan
				  contract, evidence of coverage, certificate of coverage, schedule of benefits,
				  or any other contract for health coverage between an enrollee or subscriber and
				  health plan.
(2) "Dosage form" is
				  the physical form in which a prescription drug is produced and dispensed, such
				  as a tablet, a capsule, or an injectable.
(3) "Established name" is the official
				  nonproprietary name for a prescription 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.
(4)
				  "Exception request" is the process by which an enrollee requests and gains
				  access to clinically appropriate nonformulary drugs as set forth in sections
				  1367.24,
				  1367.241,
				  and
				  1367.244
				  of the Health and Safety Code.
(5)
				  "Exigent circumstances" is when an enrollee is suffering from a health
				  condition that may seriously jeopardize the enrollee's life, health, or ability
				  to regain maximum function or when an enrollee is undergoing a current course
				  of treatment using a nonformulary drug.
(6) "Formulary" is the complete list of
				  prescription drugs preferred for use and eligible for coverage under a health
				  plan product, and includes all drugs covered under the outpatient prescription
				  drug benefit of the health plan product.
(7) "Nonformulary drug" is any prescription
				  drug where an enrollee's copayment or out-of-pocket costs are different than
				  the copayment or out-of-pocket costs for a formulary prescription drug, except
				  as otherwise provided by law or regulation.
(8) "Prescription drug" or "drug" is a drug
				  approved by the federal Food and Drug Administration (FDA) for sale to
				  consumers that requires a prescription and is not provided for use on an
				  inpatient basis. The term "drug" or "prescription drug" includes:
(A) 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;
(B) syringes for
				  self-injectable prescription drugs that are not dispensed in pre-filled
				  syringes;
(C) drugs, devices, and
				  FDA-approved products covered under the prescription drug benefit of the
				  product pursuant to sections
				  1367.002,
				  1367.25,
				  and
				  1367.51
				  of the Health and Safety Code, including any such over-the-counter drugs,
				  devices, and FDA-approved products; and
(D) at the option of the health plan, any
				  vaccines or other health care benefits covered under the prescription drug
				  benefit of the health plan product.
(9) "Product" is a discrete package of health
				  care coverage benefits that a health plan offers for a particular policy with a
				  specific network service area.
(10)
				  "Quantity Limit" is a restriction on the number of doses or any other
				  limitations on the quantity of a prescription drug a health plan will cover
				  during a specific time period.
(11)
				  "Strength" is the amount of active ingredient or ingredients present in each
				  dose of a prescription drug.