Or. Admin. Code § 431-121-2000

Current through Register Vol. 63, No. 12, December 1, 2024

Section 431-121-2000 - Definitions

(1) "340B" means Section 340B of the Public Health Service Act, "Limitation on Prices of Drugs Purchased by Covered Entities," and any and all related rules, guidance, interpretations, and operational directives adopted by the federal Health Resources and Services Administration (HRSA) or any other governmental agency with jurisdiction over the enforcement of Section 340B.

(2) "Administrator" means the Administrator of the Oregon Prescription Drug Program (OPDP).

(3) "Authority" means the Oregon Health Authority.

(4) A "Critical Access Pharmacy (CAP)" is defined as a pharmacy in Oregon that provides pharmacy services in communities at greatest risk of experiencing a pharmacy closure. To qualify as a CAP, except for (a) and (d) below, the pharmacy must have Oregon-based ownership, be public facing, and provide access to immunizations and either medication therapy management or pharmacist protocol-based prescribing. All pharmacies located on tribal lands or serving tribal communities will be designated as a CAP. In alignment with urban, rural, and frontier designations determined by the Office of Rural Health (ORH), a critical access pharmacy will meet the following criteria:

(a) In a frontier county, a critical access pharmacy is one that is further than a ten-mile radius from any other pharmacy. (If one CAP's ten-mile radius intersects with that of another CAP, both shall be considered a CAP if either CAP's closure could result in impaired access for rural areas.) Additionally, if a county has three or fewer pharmacies, all pharmacies, regardless of ownership, will be considered a CAP.

(b) In a rural zip code, a critical access pharmacy is one that is further than a ten-mile radius from any other pharmacy. (If one CAP's ten-mile radius intersects with that of another CAP, both shall be considered a CAP if either CAP's closure could result in impaired access for rural areas.) Additionally, if the pharmacy has Oregon based ownership and is located in a high poverty census tract (as defined by the US census bureau), it will be considered a CAP.

(c) In an urban zip code, a pharmacy may be considered a CAP if the pharmacy has Oregon based ownership and is the sole pharmacy located in a high poverty census tract (as defined by the US census bureau).

(d) A pharmacy may be designated as a CAP at the discretion of the Director of the OPDP accounting for factors related to pharmacy access.

(e) Assessment of CAP designation will be conducted quarterly. Pharmacies that previously qualified as a CAP, but no longer meet the aforementioned criteria, will have 12 months before losing this designation.

(5) "Designated Entity" means an entity contracted by the Authority to perform administrative duties of the OPDP including but not limited to determining program prices, processing and paying claims, issuing identification cards, maintaining eligibility files, network development maintenance, and performing replenishment administration. Designated entities may include but are not limited to pharmacy benefits managers, third party administrators, insurance carriers, health maintenance organizations (HMOs), mail order and specialty drug suppliers, replenishment administrators, group purchasing organizations, and wholesalers.

(6) "Discount Card Program" or "DCP" means a state pharmacy benefit program for eligible uninsured individuals pursuant to ORS 414.312(4)(e) administered by the OPDP.

(7) "Group Purchasing Organization (GPO)" means any organization purchasing on a group basis established to meet the criteria of the Nonprofit Institutions Act, 15 USC 13c, or that is exempt under the Robinson Patman Antidiscrimination Act, 15 USC 13, or is a governmental entity performing traditional government functions.

(8) "Mail Order Pharmacy" means a pharmacy that fulfills prescriptions by mail or other delivery service.

(9) "Member" means individuals enrolled in a participating program to receive services under the OPDP.

(10) "Participating Program" means:

(a) A group, facility, or entity that is eligible to participate in the OPDP pursuant to ORS 414.312(4) and has a participation agreement with the OPDP; or

(b) A DCP for individual Oregon residents who lack or are underinsured for prescription drug coverage pursuant to ORS 414.312(4)(e).

(11) "Pharmacy Benefit Manager (PBM)" means an entity that negotiates and executes contracts with pharmacies, manages Preferred Drug Lists (PDL), negotiates rebates with prescription drug manufacturers, and serves as an intermediary between the Administrator, prescription drug manufacturers, and pharmacies.

(12) "Pharmacy Provider" means retail, mail order, and specialty drug outlets that participate in the OPDP and that contract with the Authority or a designated entity as a pharmacy provider.

(13) "Preferred Drug List (PDL)" means a list of preferred prescription drugs in selected classes that the Authority, in consultation with the Office for Oregon Health Policy and Research (OHPR), has determined represent the most effective drugs available at the best possible price.

(14) "Prescription Drug" means:

(a) A drug prescribed by a prescribing practitioner;

(b) Supplies necessary to administer a prescription drug in a safe and effective manner, including but not limited to inhaler, spacers, diabetic test strips, syringes, and meters.

(15) "Prescribing Practitioner" means a physician or other practitioner authorized by law to prescribe prescription drugs.

(16) "Prescription Drug Claims Processor" (PDCP) means an entity that processes and pays prescription drug claims, adjudicates pharmacy claims, transmits prescription drug prices and claims data between pharmacies and the OPDP, and processes payments to pharmacies.

(17) "Program Price" means the reimbursement rates and prescription drug prices established by the OPDP Administrator directly or indirectly through a contract with a designated entity, including program cost, dispensing or administration fees, and all applicable manufacturers discounts and rebates.

(18) "Rebate" means all payments or discounts whether retrospective or not, including promotional or volume-related refunds, incentives or other credits however characterized, pre-arranged with pharmaceutical companies on certain prescription drugs, which are paid to or on behalf of OPDP or a designated entity, and are directly attributable to the utilization of certain drugs by members including administrative fees and software or data fees paid by pharmaceutical companies to OPDP or a designated entity. Rebate includes all rebates, discounts, payments or benefits (however characterized) generated by participating program's claims, or derived from any other payment or benefit for the dispensing of prescription drugs or classes or brands of drugs within participating program or arising out of any relationships OPDP or designated entity has with pharmaceutical companies, including but not limited to rebate sharing, market share allowances, educational allowances, gifts, promotions, or other form of revenue.

(19) "Replenishment Administration" means tracking GPO or 340B program usage by pharmacy providers and ordering replacement inventory including associated reporting; GPO and 340B retail and mail order pharmacy contracting; GPO and 340B contracting; or as otherwise defined by contract.

(20) "Retail Pharmacy" means a pharmacy in a retail store and excludes any mail order pharmacy or specialty pharmacy.

(21) "Specialty Pharmacy" means a pharmacy provider where specialty drugs are dispensed and delivered to members or to prescribing practitioners for members.

(22) "Third Party Administrator (TPA)" means an entity that, in addition to being a PDCP, facilitates program management including processing and paying prescription drug claims; transmitting prescription drug prices and claims and enrollment data between pharmacies and the OPDP and its participating programs; maintaining enrollment and issuing identification cards; and processing payments to pharmacies. The TPA may be contracted through the Authority or PBMs, or other designated entities.

Or. Admin. Code § 431-121-2000

OHP 1-2004, f. & cert. ef. 9-24-04; OHP 2-2006(Temp), f. & cert. ef. 11-28-06 thru 5-23-07; OHP 2-2007(Temp), f. & cert. ef. 5-16-07 thru 11-6-07; OHP 3-2007, f. & cert. ef. 8-3-07; OHP 3-2009, f. & cert. ef. 10-1-09; Renumbered from 409-030-0000 by DMAP 1-2011, f. 2-10-11, cert. ef. 3-1-11; DMAP 10-2012, f. 3-6-12, cert. ef. 3-13-12; Renumbered from 410-121-2000, OPDP 1-2015, f. & cert. ef. 2/18/2015; OPDP 1-2024, amend filed 05/17/2024, effective 5/17/2024

Statutory/Other Authority: ORS 414.320

Statutes/Other Implemented: ORS 414.312 - 414.320