836-053-1020 Drug Formularies (1) For purposes of OAR 836-053-0000 to 836-053-1200: (a) "Open formulary" means a method used by an insurer to provide prescription drug benefits in which all prescribed FDA approved prescription drug products are covered except for any drug product that is excluded by the insurer pursuant to the insurer's policy regarding medical appropriateness or by the terms of a specific health benefit plan, or except for an entire class of drug product that is excluded by the insurer. (b) "Closed formulary" means a method used by an insurer to provide prescription drug benefits in which only specified FDA approved prescription drug products are covered, as determined by the insurer, but in which medical exceptions are allowed. Maximum benefits or coverage may be limited to formulary drugs in a health benefit plan with a closed formulary. (c) "Mandatory closed formulary" means a method used by an insurer to provide prescription drug benefits in which only specified FDA approved prescription drug products are covered, as determined by the insurer, and in which no exceptions are allowed. (2) An insurer that uses an open formulary must have a written procedure that includes the written criteria or explains the review process established by the insurer for determining when an item will be limited or excluded pursuant to the insurer's policy regarding medical appropriateness. (3) An insurer that uses a closed formulary must have a written procedure stating that FDA approved prescription drug products are covered only if they are listed in the formulary. The procedure must also describe how the insurer determines the content of the closed formulary and how the insurer determines the application of a medical exception. The procedure must describe how a provider may request inclusion of a new item in the closed formulary and must ensure that the insurer will issue a timely written response to a provider making such a request. (4) An insurer that uses a mandatory closed formulary must have a written procedure stating that FDA approved prescription drug products are covered only if they are listed in the formulary and that no exception is allowed. The procedure must describe how the insurer determines the content of the mandatory closed formulary. The procedure must also describe how a provider may request inclusion of a new item in the formulary and must ensure that the insurer will issue a timely written response to a provider making such a request. (5) An insurer must furnish a copy of the procedures it has adopted under section (2), (3) or (4) of this rule to a provider with authority to prescribe drugs and medications, upon the request of the provider. (6) Except as provided in section (7) of this rule, a formulary must comply with the requirements of 45 CFR 156.122 and include the greater of: (a) At least one drug in every United States Pharmacopeia therapeutic category and class; or (b) The same number of drugs in each United States Pharmacopeia category and class as the prescription drug benefit of the plan described in OAR 836-053-0008(1)(a). (7) An insurer that issues a small group or individual health benefit plan formulary that does not comply with the requirements of section (6) of this rule must file with the director of the Department of Consumer and Business Services the form entitled “Formulary-Inadequate Category/Class Count Justification” as set forth on the website of the Department of Consumer and Business Services at dfr.oregon.gov. The director, in the director’s discretion, may consider approval of a formulary that does not meet the requirements of section (5) of this rule if: (a) Drugs in a category or class have been discontinued by the manufacturer; (b) Drugs in a category or class have been deemed unsafe by the Food and Drug Administration or removed from market by the manufacturer due to safety concerns; (c) Drugs in a category of class have a Drug Efficacy Study Implementation classification; (d) Drugs in a category or class have become available as generics; or (e) Drugs in a category or class are provided in a medical setting and are covered under the medical provisions of the plan. (8) An insurer that issues a small group or individual health benefit plan formulary does not comply with the nondiscrimination requirements of OAR 836-053-0012 if most or all drugs to treat a specific condition are placed in the highest cost tier. (9) A health benefit plan providing essential health benefits must have procedures in place that allow an enrollee to request and gain access to clinically appropriate prescription drugs not covered by the health plan. (10) An insurer may file a Bronze or Silver standard plan that substitutes a different prescription drug benefit from the prescription drug benefit described in the benchmark plan, provided that the insurer demonstrates that its proposed benefit complies with the prescription drug formulary requirements and will have a Bronze or Silver actuarial value. Statutory/Other Authority: ORS 731.244 & ORS 731.097 Statutes/Other Implemented: ORS 731.097 & ORS 743.804 History: ID 19-2023, minor correction filed 06/23/2023, effective 06/23/2023 ID 5-2016, f. & cert. ef. 4-26-16 ID 14-2015(Temp), f. & cert. ef. 12-17-15 thru 5-1-16 ID 12-2013, f. 12-31-13, cert. ef. 1-1-14 ID 1-1998, f. & cert. ef. 1-15-98