Effective Date of Rule: Immediately.
Purpose: The rule explains the commissioner's minimum standard for approval or disapproval of a health benefit plan that includes a prescription drug benefit, in particular as it relates to coverage of generic and brand name drugs, so that the plan does not structure the prescription drug benefit in a way that establishes an unreasonable restriction on the treatment of patients, or that deceptively or unreasonably affects the risk the general coverage of the plan contract or agreement purports to assume. The rule is intended to apply to any health benefit plan with a prescription drug benefit offered or issued in Washington by a health carrier, as defined in RCW 48.43.005. In addition, the rule is being issued to confirm notice to health carriers of the commissioner's approval standard to facilitate their internal work on product design and benefit structure.
Statutory Authority for Adoption: RCW 48.02.060, 48.18.110, 48.18.140, 48.21.200, 48.44.020, 48.44.050, 48.46.060.
Under RCW 34.05.350 the agency for good cause finds that immediate adoption, amendment, or repeal of a rule is necessary for the preservation of the public health, safety, or general welfare, and that observing the time requirements of notice and opportunity to comment upon adoption of a permanent rule would be contrary to the public interest.
Reasons for this Finding: Because some medical conditions require prescription medication for which there is not a therapeutically equivalent generic alternative or for which the generic alternative is not efficacious based on a person's clinical response, a generic only drug benefit prevents a covered person from being able to use their purchased insurance plan to help pay for medically necessary medicine or drugs, unreasonably restricting their treatment. Therefore, the commissioner finds that if a person buys a health benefit plan with a prescription drug benefit where the benefit strictly limits covered drugs to generic products, they are purchasing a plan that offers an illusory benefit. An emergency rule is necessary because some health carriers are continuing to apply a generic only benefit in this way, and have not re-filed their product for the commissioner's approval to correct the problem.
Other carriers have filed products for approval that include a generic only product, which must be disapproved. This rule is necessary to protect the public from being at risk of purchasing a product that provides full medical coverage but insufficient prescription coverage to treat the covered medical condition, and to preclude carriers from unnecessarily preparing a rate and form filing for approval to offer a product that does not meet state standards in this regard.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Initiative: New 1, Amended 0, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.
Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 1, Amended 0, Repealed 0.
Date Adopted: February 15, 2012.
WAC 284-43-817 Prescription drug benefit -- Generic drugs. (1) A health carrier must not offer, renew, or issue a health benefit plan providing a prescription drug benefit after August 1, 2012, that limits the prescription drug benefit to generic drugs or otherwise applies a prescription drug benefit structure, including a formulary, that the commissioner determines results or can reasonably be expected to result, in an unreasonable restriction on the treatment of patients.
(2) This requirement does not prohibit a health benefit plan from:
(a) Using a tiered prescription drug benefit structure that includes a generic tier. The prescription drug benefit must cover brand name drugs when no generic drug is available, when the available generic is not therapeutically equivalent or if the provider determines that the generic is not efficacious based on the patient's clinical response;
(b) Applying lower cost-sharing for generic drugs that are therapeutically equivalent to a prescribed brand name product;
(c) Using a step therapy protocol;
(d) Requiring substitution of a therapeutically equivalent generic drug for a brand name product with the prescribing physician's approval or direction. A carrier must cover a brand name drug if the prescribing provider determines that the generic substitute is not efficacious based on the patient's clinical response or that the brand name drug does not have a therapeutically equivalent generic drug for the patient's condition;
(e) Requiring preauthorization for prescription of a brand name drug based on the patient's clinical response. The preauthorization process must not unreasonably restrict treatment or the health of the patient, and must be fully set forth in the health benefit contract or benefit booklet.
(3) Upon the effective date of this rule, the commissioner must disapprove a health benefit plan if the prescription drug benefit does not comply with this rule, provided that the health benefit plan was filed prior to, on, or after the effective date of this rule and such plan has not been offered or issued in the market.
(4) For purposes of this section, "brand name," "generic name," "substitute," and "therapeutically equivalent," have the meaning set forth in RCW 69.41.110.