80th OREGON LEGISLATIVE ASSEMBLY Regular Session. Senate Bill 572

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0th OREGON LEGISLATIVE ASSEMBLY--0 Regular Session Senate Bill Sponsored by Senator HANSELL, Representative SMITH G; Senator LINTHICUM (at the request of Oregon State Pharmacy Coalition) (Presession filed.) SUMMARY The following summary is not prepared by the sponsors of the measure and is not a part of the body thereof subject to consideration by the Legislative Assembly. It is an editor s brief statement of the essential features of the measure as introduced. Imposes new requirements on pharmacy benefit managers registered in this state. Declares emergency, effective on passage. 0 0 0 A BILL FOR AN ACT Relating to pharmacy benefit managers; creating new provisions; amending ORS.0 and.; and declaring an emergency. Be It Enacted by the People of the State of Oregon: SECTION. Section of this 0 Act is added to and made a part of ORS.0 to.. SECTION. A pharmacy benefit manager registered in this state: () May not require an enrollee to fill or refill prescriptions at a mail order pharmacy. () May require drugs that are specialty drugs to be dispensed at a network pharmacy that is a specialty pharmacy. () May not require a specialty drug to be dispensed at a specialty pharmacy based on the cost of the drug. () Shall allow a network pharmacy to choose to mail, ship or deliver prescription drugs to its patients. () May not require a patient signature as proof of delivery of a mailed or shipped prescription drug if the network pharmacy maintains a mailing or shipping log signed by a representative of the pharmacy or maintains each notification of delivery provided by the United States Postal Service or a package delivery service. () May not impose unreasonable requirements with respect to specialty pharmacies that seek to contract with the pharmacy benefit manager. () May require a specialty pharmacy to be accredited by no more than one nationally recognized accrediting body. A specialty pharmacy that has an accreditation from any nationally recognized accrediting body must be considered to have met the requirement for accreditation and a pharmacy benefit manager may not require additional accreditation. SECTION. ORS.0 is amended to read:.0. As used in ORS.0 to.: () Claim means a request from a pharmacy or pharmacist to be reimbursed for the cost of filling or refilling a prescription for a drug or for providing a medical supply or service. () Enrollee means an individual who is a beneficiary under a policy or certificate of health insurance or covered by a self-insured health benefit plan for which a pharmacy benefit manager reimburses claims submitted by pharmacies for the costs of prescription drugs. NOTE: Matter in boldfaced type in an amended section is new; matter [italic and bracketed] is existing law to be omitted. New sections are in boldfaced type. LC

SB 0 0 0 0 ()(a) Generally available for purchase means a drug is available for purchase by similarly situated pharmacies from a national or regional wholesaler at the time a claim for reimbursement is submitted by a network pharmacy. (b) A drug is not generally available for purchase if the drug: (A) Must be dispensed at a hospital or in an institutional setting; (B) Is available at a price that is at or below the maximum allowable cost only if purchased in quantities that materially exceed the dispensing needs of similarly situated pharmacies; (C) Is available at a price that is at or below the maximum allowable cost only if purchased at a discount due to a short expiration date on the drug; or (D) Is the subject of a recall notice. [()] () Insurer has the meaning given that term in ORS.0. () List means the list of drugs for which maximum allowable costs have been established. () Mail order pharmacy means a pharmacy for which the primary business is to receive prescriptions by mail, telephone or electronic transmission and dispense drugs to patients through the use of the United States Postal Service, a package delivery service or home delivery. () Maximum allowable cost means the maximum amount that a pharmacy benefit manager will reimburse a pharmacy for the cost of a drug. () Multiple source drug means a therapeutically equivalent drug that is available from at least two manufacturers. () Network pharmacy means a retail drug outlet registered under ORS.0 that contracts with a pharmacy benefit manager. [()] (0) Pharmacist has the meaning given that term in ORS.00. [()] () Pharmacy includes: (a) A pharmacy as defined in ORS.00; and (b) An entity that provides or oversees administrative services for two or more pharmacies. [()(a)] ()(a) Pharmacy benefit manager means a person that contracts with pharmacies on behalf of an insurer, a third party administrator or the Oregon Prescription Drug Program established in ORS. to: (A) Process claims for prescription drugs or medical supplies or provide retail network management for pharmacies or pharmacists; (B) Pay pharmacies or pharmacists for prescription drugs or medical supplies; or (C) Negotiate rebates with manufacturers for drugs paid for or procured as described in this paragraph. (b) Pharmacy benefit manager does not include a health care service contractor as defined in ORS 0.00. () Similarly situated pharmacies means pharmacies that: (a) Are located in this state; (b) Are similar in size and in the same type of trade, such as independent, retail chain, supermarket, mass merchandiser, mail order or specialty; and (c) Have contracted with a pharmacy benefit manager on the same terms. () Specialty drug means a drug, regardless of cost: (a) That requires difficult or unusual: []

SB 0 0 0 0 (A) Preparation; (B) Handling; (C) Storage; (D) Inventory; or (E) Distribution; (b) That has difficult or unusual data collection or administrative requirements associated with it; (c) For which the United States Food and Drug Administration requires a Risk Evaluation and Mitigation Strategy; or (d) That requires a pharmacist to manage the patient s use of the drug by: (A) Monitoring; or (B) Providing disease or therapeutic support systems. () Specialty pharmacy means a pharmacy capable of meeting the requirements applicable to specialty drugs. () Therapeutically equivalent has the meaning given that term in ORS.. [()] () Third party administrator means a person licensed under ORS.0. () Wholesale acquisition cost has the meaning given that term in U.S.C. w-a(c)()(b). SECTION. ORS. is amended to read:.. [() As used in this section:] [(a) List means the list of drugs for which maximum allowable costs have been established.] [(b) Maximum allowable cost means the maximum amount that a pharmacy benefit manager will reimburse a pharmacy for the cost of a drug.] [(c) Multiple source drug means a therapeutically equivalent drug that is available from at least two manufacturers.] [(d) Network pharmacy means a retail drug outlet registered under ORS.0 that contracts with a pharmacy benefit manager.] [(e) Therapeutically equivalent has the meaning given that term in ORS..] [()] () A pharmacy benefit manager: (a) May not place a drug on a list unless there are at least two [therapeutically equivalent,] multiple source drugs, or at least one generic drug generally available for purchase [from only one manufacturer, generally available for purchase by network pharmacies from national or regional wholesalers]. (b) Shall ensure that all drugs on a list are generally available for purchase [by pharmacies in this state from national or regional wholesalers]. (c) Shall ensure that [all drugs] no drug on a list [are not] is obsolete. (d) Shall make available to each network pharmacy at the beginning of the term of a contract, and upon renewal of a contract, the [sources utilized] specific authoritative industry sources, other than proprietary sources, the pharmacy benefit manager uses to determine the maximum allowable cost [pricing of] set by the pharmacy benefit manager. (e) Shall make a list available to a network pharmacy upon request in a format that [is readily accessible to and usable by the network pharmacy.]: (A) Is electronic; (B) Is computer accessible and searchable; (C) Identifies all drugs for which maximum allowable costs have been established; and []

SB 0 0 0 0 (D) For each drug specifies: (i) The national drug code; (ii) The maximum allowable cost; and (iii) The date and time when the maximum allowable cost goes into effect. (f) Shall update each list maintained by the pharmacy benefit manager every seven business days and make the updated lists, including all changes in the price of drugs, available to network pharmacies in [a readily accessible and usable format] the format described in paragraph (e) of this subsection. (g) Shall ensure that dispensing fees are not included in the calculation of maximum allowable cost. [()] () A pharmacy benefit manager must establish a process by which a network pharmacy may appeal [its reimbursement for a drug subject to maximum allowable cost pricing. A network pharmacy may appeal a maximum allowable cost if the reimbursement for the drug is less than the net amount that the network pharmacy paid to the supplier of the drug. An appeal requested under this section must be completed within 0 calendar days of the pharmacy making the claim for which appeal has been requested] the reimbursement paid by the pharmacy benefit manager if the reimbursement is less than the pharmacy s net cost of the drug as reflected on the invoice from the supplier of the drug. The process must allow a pharmacy no less than 0 days after the claim is reimbursed to file the appeal. () A pharmacy benefit manager shall allow a network pharmacy to submit the documentation in support of its appeal in paper or electronically and may not: (a) Refuse to accept an appeal submitted by a person acting on behalf of the network pharmacy; (b) Refuse to accept an appeal for the reason that the appeal is submitted along with other claims or appeals; or (c) Impose requirements or establish procedures that have the effect of unduly obstructing or delaying an appeal. () A pharmacy benefit manager must provide as part of the appeals process established under subsection [()] () of this section: (a) A telephone number at which a network pharmacy may contact the pharmacy benefit manager and speak with an individual who is responsible for processing appeals; (b) A final response to an appeal of a maximum allowable cost within seven business days; and (c) If the appeal is denied[,]: (A) The reason for the denial and the national drug code of a multiple source drug or generic drug that may be purchased by similarly situated pharmacies at a price that is [equal to or less than] at or below the maximum allowable cost. (B) If the reason for the denial is that the drug was generally available for purchase at a price that was at or below the maximum allowable cost, the location where the drug was available at that price when the claim for reimbursement was submitted by the network pharmacy. ()(a) If an appeal is upheld under this section, the pharmacy benefit manager shall [make an adjustment for the pharmacy that requested the appeal from the date of initial adjudication forward]: (A) Reimburse the network pharmacy s claim as submitted; (B) Allow the network pharmacy to submit an adjusted claim and reimburse the adjusted claim without any additional charges; and []

SB 0 (C) Increase the reimbursement to equal to the network pharmacy s net cost of the drug, as reflected on the invoice from the supplier of the drug, for all subsequent claims for the drug by the network pharmacy and all similarly situated pharmacies under the same ownership, until the wholesale acquisition cost of the drug changes. (b) If the request for an adjustment has come from a critical access pharmacy, as defined by the Oregon Health Authority by rule for purposes related to the Oregon Prescription Drug Program, the adjustment approved under paragraph (a) of this subsection shall apply only to critical access pharmacies. () This section does not apply to the state medical assistance program. SECTION. Section of this 0 Act and the amendments to ORS.0 and. by sections and of this 0 Act apply to contracts between pharmacies or pharmacists and pharmacy benefit managers that are entered into, renewed or extended on or after the effective date of this 0 Act. SECTION. This 0 Act being necessary for the immediate preservation of the public peace, health and safety, an emergency is declared to exist, and this 0 Act takes effect on its passage. []