OAR 836-200-0440: Market Conduct Requirements for Pharmacy Benefit Managers

(1) A pharmacy benefit manager shall allow a network pharmacy to mail, ship or deliver prescription drugs to its patients as an ancillary service. A contract between a pharmacy benefit manager and a network pharmacy may establish limits and parameters on the pharmacy’s mail, shipment and/or delivery of prescription drugs on the request of enrollees based on the pharmacy’s total prescription volume. A pharmacy benefit manager is not required to reimburse a delivery fee charged by a network pharmacy unless the fee is specified in the contract between the pharmacy benefit manager and the pharmacy. (2) Except as provided in subsection (6) of this rule, a pharmacy benefit manager may require a prescription for a specialty drug to be filled or refilled at a specialty pharmacy as a condition for the reimbursement of the cost of a drug. (3) For the purposes of subsection (2) of this section, the department will consider a prescription drug to meet the definition of “specialty drug” under ORS 735.530 if, to be properly dispensed according to standard industry practice, the drug: (a) Requires specialized preparation, administration, handling, storage, inventory, reporting or distribution; (b) Is associated with difficult or unusual data collection or administrative requirements; or (c) Requires a pharmacist to manage the patient’s use of the drug by monitoring, provide disease or therapeutic support systems, provide care coordination including collaboration with patients or other health care providers to manage adherence, identify side effects, monitor clinical parameters, assess responses to therapy, or document outcomes. (4) For the purposes of subsection (2) of this section, a pharmacy may demonstrate to the department that it meets the definition of “specialty pharmacy” under ORS 735.530 by showing that: (a) Its business is primarily providing specialty drugs and specialized, disease-specific clinical care and services for people with serious or chronic health conditions requiring complex medication therapies; or (b) It has been validated for meeting quality, safety and accountability standards for specialty pharmacy practice through accreditation in specialty pharmacy by a nationally recognized, independent accreditation organization such as URAC or the Accreditation Commission for Health Care (ACHC). (5) Nothing in subsection (4) of this section shall be construed to prohibit a pharmacy benefit manager from specifying additional terms and conditions for a specialty pharmacy network contract, including terms and conditions related to reimbursement. (6) A pharmacy benefit manager shall reimburse the cost of a specialty drug that is filled or refilled at a network pharmacy that is a long term care pharmacy, provided that the specialty drug is dispensed to an enrollee who is a resident of a long term care facility served by the long term care pharmacy. (7) A pharmacy benefit manager may not require a prescription to be filled or refilled by a mail order pharmacy as a condition for reimbursing the cost of the drug. (8) A network pharmacy may appeal its reimbursement from a pharmacy benefit manager for a drug subject to maximum allowable cost pricing on the basis that the reimbursement for the drug is less than the net amount that the network pharmacy paid to the supplier of the drug. (a) If the pharmacy benefit manager denies a pharmacy’s appeal under this rule, it must provide the reason for the denial and identify a national drug code for the drug, generally available for purchase by similarly situated pharmacies, and national or regional wholesalers where that national drug code was listed at a price equal to or less than the maximum allowable cost for the drug at the time that the claim in question was adjudicated. (b) For the purposes of this rule, “generally available for purchase” means a drug is available for purchase in this state by a pharmacy from a national or regional wholesaler at the time a claim for reimbursement is submitted by a network pharmacy. A drug is not “generally available for purchase” if the drug: (A) May only be dispensed in a hospital or inpatient care facility; (B) Is unavailable due to a shortage of the product or an ingredient; (C) Is available to a pharmacy at a price at or below the maximum allowable cost only if purchased in substantial quantities in excess of its business needs. For the purposes of this subsection, a quantity in excess of the business needs of a network pharmacy is defined as a purchase quantity greater than a 3-month supply based on the pharmacy’s total dispensing history over the most recent rolling 12 months. A pharmacy benefit manager may require a network pharmacy appealing its reimbursement for a drug in accordance with this subsection to submit applicable evidence of its dispensing history to the pharmacy benefit manager as part of the appeal process. (D) Is sold at a discount due to a short expiration date on the drug; or (E) Is the subject of an active or pending recall. (c) The appeals process required by ORS 735.534(4) must provide the pharmacy the opportunity to rebut an appeal on the basis that the NDC provided in the denial is not generally available for purchase for similarly situated pharmacies for one of the reasons described in subsection (8)(b) of this rule. (d) If an appeal is upheld under this rule, the pharmacy benefit manager must make an adjustment for the appealing pharmacy from the date of initial adjudication forward and allow the pharmacy to reverse the claim and resubmit an adjusted claim without any charges. (e) If a prescription drug subject to a specified maximum allowable cost is available at that price if purchased in quantities that are consistent with the business needs of some pharmacies but inconsistent with the business needs of others, nothing in subsection (8) shall be construed to prohibit a pharmacy benefit manager from applying the maximum allowable cost to pharmacies that can purchase the drug in the necessary quantities consistent with their business needs. (f) If the request for an adjustment has come from a “critical access pharmacy”, as defined by the Oregon Health Authority in OAR 431-121-2000, the adjustment approved under subsection (8) of this rule is only required to apply to critical access pharmacies. (9) A pharmacy benefit manager may not retroactively deny or reduce payment on a claim for reimbursement of the cost of services after the claim has been adjudicated by the pharmacy benefit manager unless the: (a) Adjudicated claim was submitted fraudulently. For the purposes of this section, “fraud” has the meaning defined in ORS 735.540; (b) The payment was incorrect because the pharmacy had already been paid for the services; (c) Services were improperly rendered by the pharmacy in violation of state or federal law; or (d) The payment was incorrect due to an error that the pharmacy and pharmacy benefit manager agree was a clerical error. (10) A pharmacy benefit manager may not impose a fee for a particular claim on a pharmacy after the point of sale. For the purposes of this subsection, “point-of-sale” means the time that the claim was adjudicated. (11) A pharmacy benefit manager may not penalize a network pharmacy for: (a) Appealing the reimbursement of a drug to the pharmacy benefit manager; (b) Filing a complaint against the pharmacy benefit manager with the department; (c) Engaging in the legislative process; or (d) Challenging the pharmacy benefit manager’s practices or agreements. (12) For the purposes of subsection (11) of this rule, “penalize” includes but is not limited any of the following actions if applied to a network pharmacy that has engaged in the protected conduct described in subsections (11)(a) to (d) of this rule differently from similarly situated pharmacies that have not engaged in said protected conduct: imposing charges or fees, requiring contract amendments, canceling or terminating contracts, demanding recoupment, or conducting an unnecessary or unwarranted audit of a pharmacy. (13) A pharmacy benefit manager may not charge a fee to a pharmacy for submitting claims or for the adjudication of claims. (14) Nothing in subsections (9) and (11) of this rule shall be construed as limiting a pharmacy benefit manager from conducting a pharmacy claims audit that is in compliance with the requirements of ORS 735.540 to 735.552.