Or. Admin. Code § 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.
Notes
Statutory/Other Authority: ORS 414.320
Statutes/Other Implemented: ORS 414.312 - 414.320
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