§ 9.673. Plan provision of prescription drug benefits to enrollees.
(a) A plan providing prescription drug benefit coverage to enrollees, either as a basic benefit or through the purchase of a rider or additional benefit package, and using a drug formulary which lists the plan’s preferred therapeutic drugs, shall clearly disclose in its marketing material and enrollee literature that restrictions in drug availability may result from use of a formulary.
(b) An enrollee, a prospective enrollee, or health care provider may make a written or verbal inquiry to a plan asking whether a specific drug is on the plan’s formulary. The plan shall respond in writing to the request within 30 days from the date of its receipt of the request. If the drug that is the subject of the inquiry is not on the plan’s formulary, the plan’s response shall include a listing of the drugs in the same class that are on the formulary or instruct the enrollee how to access the formulary.
(c) A plan utilizing a drug formulary shall have a written policy that includes an exception process by which a health care provider may prescribe and obtain coverage for the enrollee for specific drugs, drugs used for an off-label purpose, biologicals and medications not included in the formulary for prescription drugs or biologicals when the formulary’s equivalent has been ineffective in the treatment of the enrollee’s disease or if the drug causes or is reasonably expected to cause adverse or harmful reactions to the enrollee. The following standards apply when an exception is sought:
(1) Exception requests are to be considered requests for prospective UR decisions and shall be processed within 2-business days.
(2) If the exception is granted, the plan shall provide coverage in the amount disclosed by the plan for the nonformulary alternative under section 2136(a)(1) of the act (40 P. S. § 991.2136(a)(1)).
(3) A letter denying the request shall include the basis and clinical rationale for the denial and instructions on how to file a complaint or a grievance.
(d) The plan shall distribute its policy and process to each participating health care provider who prescribes. A plan shall provide a description of the process to be used to obtain coverage of a drug that is an exception to the formulary to an enrollee or prospective enrollee upon request. If a drug, class of drugs or drugs used to treat a specific condition are specifically excluded from coverage in the enrollee contract, appeals for coverage of specific exclusions shall be considered complaints. If no specific exclusion exists, the appeal of a denial of a physician’s request for an exception to the formulary based on medical necessity and appropriateness, shall be considered to be a grievance.
(e) A plan shall provide at least 30 days notice of formulary changes to health care providers, except when the change is due to approval or withdrawal of approval of the Food and Drug Administration of a drug.
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