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OREGON HEALTH AUTHORITY

OREGON PRESCRIPTION DRUG PROGRAM







 

DIVISION 121
OREGON PRESCRIPTION
DRUG PROGRAM
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) “Critical Access
Pharmacy (CAP)” means a pharmacy in Oregon 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.
(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.
Stat. Auth.: ORS 414.320
Stats. Implemented: ORS 414.312
- 414.320
Hist.: 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. 2-18-15
431-121-2005
General Administration
(1) The Administrator, or designee,
may:
(a) Negotiate price discounts
and rebates on prescription drugs with prescription drug manufacturers and GPOs;
(b) Purchase prescription
drugs on behalf of participating programs;
(c) Contract with a PDCP
or PBM to adjudicate pharmacy claims and transmit program prices to pharmacies;
(d) Determine program prices
and reimburse or replenish pharmacies for prescription drugs dispensed or transferred;
(e) Adopt and implement a
PDL for the OPDP;
(f) Develop a system for
allocating and distributing the operational costs of the program and any rebates
obtained to participating programs; and
(g) Cooperate with any state
or regional consortia in bulk purchasing of prescription drugs.
(2) The Administrator or
designated entity shall oversee the implementation of the OPDP, including review
of member eligibility information, participating program information, and pharmacy
provider compliance with program requirements. The Administrator, or designated
entity, shall review records or other information, including health information,
necessary to perform oversight responsibilities.
(3) The Administrator shall
establish processes, terms, and conditions describing how the entities identified
in ORS 414.312(4) may participate in the OPDP as a participating program, including
entities otherwise subject to ORS 731.036(6).
(4) The Administrator or
designated entity may contract with a PBM and directly or indirectly with pharmacy
providers as the Administrator or designated entity considers necessary to maintain
statewide access for OPDP members including consideration for CAP providers.
(5) The Administrator or
designated entity may contract with replenishment administrators, GPO’s, 340B
providers, and pharmacy providers as necessary to utilize discount purchasing programs.
(6) Annually, no later than
November 1, the Office of Rural Health shall determine any Oregon pharmacies that
meet CAP status and report them to the OPDP for CAP designation. OPDP shall send
the current list of all Oregon retail pharmacies to the Office of Rural Health no
later than October l each year.
(7) Pursuant to ORS 414.312(5),
the state agency that receives federal Medicaid funds and is responsible for implementing
the state’s medical assistance program may not participate in the program.
The phrase “state agency” for this purpose means the Authority, which
is the state Medicaid agency that administers funds from Title XIX of the Social
Security Act, and is responsible for implementing the state’s Medicaid program.
State agency does not include other programs or functions within the Authority that
do not receive federal Medicaid funds, such as the Public Employees’ Benefit
Board and the Oregon Educators Benefit Board.
Stat. Auth.: ORS 414.320
Stats. Implemented: ORS 414.312
- 414.320
Hist.: OHP 1-2004, f. &
cert. ef. 9-24-04; OHP 2-2006(Temp), f. & cert. ef. 11-28-06 thru 5-23-07; Administrative
Correction, 6-16-07; OHP 3-2007, f. & cert. ef. 8-3-07; OHP 3-2009, f. &
cert. ef. 10-1-09; Renumbered from 409-030-0005 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 410-121-2005,
OPDP 1-2015, f. & cert. ef. 2-18-15
431-121-2010
Pharmacy Providers
(1) The pharmacy shall contract with
the Authority, or its designated entity, and must be licensed with their state Board
of Pharmacy to be a pharmacy provider for the OPDP.
(2) The pharmacy provider
must sign a pharmacy provider contract and comply with all applicable state and
federal laws, regulations, rules, and the terms and conditions of the contract.
The contract authorizes the pharmacy provider to serve members in the OPDP and outlines
program compliance requirements.
(3) A contract may be issued
to a qualified pharmacy provider upon:
(a) Completion and signature
of the contract by the pharmacy provider or a person authorized by the pharmacy
provider to bind the organization;
(b) Verification of Pharmacy
licensing with their State Board of Pharmacy; and
(c) Approval of the contract
by the Authority or its designated entity.
(4) To contract for the OPDP,
the pharmacy provider must:
(a) Accept the program price
in effect on the date of the transaction as established by the Administrator or
designated entity including but not limited to dispensing fees which may be charged
to the member;
(b) Maintain sufficient documentation
of transactions to resolve disagreements with the member or participating program
about the amount charged for the prescription drugs;
(c) Reimburse the member
or participating program directly for overcharges as determined by program price
in effect on the date of the transaction;
(d) Provide access to records
and data required by the designated entity to administer claims, reimbursement,
and other tasks as necessary for OPDP claims processing; and
(e) Not charge members for
costs incurred by the pharmacy provider for the electronic transmittal of the program
price from the Authority to the pharmacy.
(5) Pharmacy providers may
advertise participation in the OPDP, provided that:
(a) Advertising or marketing
materials must be accurate and not misleading or confusing to members or the public
about participation in the OPDP or the savings offered by the pharmacy provider.
(b) The pharmacy provider
must cease all advertisements pertaining to participation in the program if the
Authority suspends or terminates the contract.
(6) The Administrator or
designated entity shall, at its discretion, suspend or remove a pharmacy provider
from the OPDP if the pharmacy provider loses licensure or fails to comply with applicable
state and federal laws, rules, and regulations, and the terms and conditions of
the contract.
Stat. Auth.: ORS 414.320
Stats. Implemented: ORS 414.312
- 414.320
Hist.: OHP 1-2004, f. &
cert. ef. 9-24-04; 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 409-030-0010 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 410-121-2010, OPDP 1-2015, f. & cert.
ef. 2-18-15
431-121-2020
Program Price
(1) The price for a prescription drug
a pharmacy provider may charge a member under the OPDP is the lesser of the following
on the date of the transaction:
(a) The program price, or
(b) The pharmacy provider’s
usual and customary price, including program cost and dispensing fee.
(2) The designated entity
shall transmit the price of the prescription drugs to the pharmacy providers electronically.
(3) The OPDP is limited to
prescription drugs prescribed in the name of and for the use by the member, except
as otherwise provided in section (7) of this rule.
(4) Prescription drug benefit
access shall be available on member identification cards.
(5) The OPDP does not include
prescriptions for over-the-counter drugs.
(6) The Administrator, or
designated entity, may establish different program prices for CAP providers in rural
areas to maintain statewide access to the OPDP.
(7) Unique pricing arrangements
may be agreed upon between pharmacy providers and designated entity to accommodate
group purchasing or 340B pricing for qualified entities.
Stat. Auth.: ORS 414.320
Stats. Implemented: ORS 414.312
- 414.320
Hist.: 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 409-030-0020
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 410-121-2020, OPDP 1-2015, f. & cert. ef. 2-18-15
431-121-2030
Preferred Drug List
(1) The Administrator shall consider
any PDL developed and recommended by OHPR that identifies preferred choices of prescription
drugs within therapeutic classes for particular diseases and conditions, including
generic alternatives, for use in the OPDP by participating programs.
(2) The OPDP shall develop
a PDL that participating programs may choose to adopt for beneficiaries of their
prescription drug benefit program. The PDL shall include the most effective prescription
drugs at the lowest possible prices, taking into account negotiated price discounts
and rebates available to the OPDP, while allocating and distributing the operational
costs of the OPDP.
(3) If a participating program
uses the PDL developed by the OPDP, it must be used in conjunction with that participating
program’s benefit plan including all pharmacy management programs the participating
program has or adopts.
(4) OPDP shall make the PDL
available to individuals enrolled in the OPDP.
Stat. Auth.: ORS 414.320
Stats. Implemented: ORS 414.312
- 414.320
Hist.: OHP 1-2004, f. &
cert. ef. 9-24-04; OHP 3-2009, f. & cert. ef. 10-1-09; Renumbered from 409-030-0030
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 410-121-2030, OPDP 1-2015, f. & cert. ef. 2-18-15
431-121-2050
Enrollment
(1) Participating programs, other than
the DCP, shall enroll for participation through the designated entity chosen by
the OPDP to administer the participating program’s enrollment and claims processing.
(a) Eligibility for members
of a participating program shall be maintained electronically between the participating
program and designated entity.
(b) Participating programs
or designated entities shall issue identification cards to members at initial enrollment
and renewal, and between those times as needed.
(2) Residents of Oregon who
do not have prescription drug coverage or who are underinsured for prescription
drug coverage may be individually enrolled by the designated entity.
(a) The designated entity
shall issue identification cards to members.
(b) Individuals who are eligible
for Medicare Part D prescription drug coverage may participate in the program.
(3) The OPDP may charge a
nominal fee to participate in the program.
Stat. Auth.: ORS 414.320
Stats. Implemented: ORS 414.312
- 414.320
Hist.: 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 409-030-0050
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 410-121-2050, OPDP 1-2015, f. & cert. ef. 2-18-15
431-121-2065
Contracted Services
(1) The Administrator may procure goods
and services to perform any of the functions of OPDP.
(2) The Administrator shall
delegate procurement authority to the Authority’s designated Procurement Officer
for OPDP goods and services, except as the Administrator determines to retain such
authority in a particular case and as otherwise provided in section (4) of this
rule.
(3) The Administrator shall
act as the Authority’s representative for each contract. The Administrator
may delegate in writing the representative's responsibilities to a designee. The
agency's representative may participate with the Authority’s designated Procurement
Officer in all aspects of procurement.
(4) OPDP's mechanism for
and administration of the enrollment of participating groups shall not constitute
procurements subject to this rule.
Stat. Auth.: ORS 414.312
Stats. Implemented: ORS 414.312,
414.314, 414.316 & 414.318
Hist.: OHP 3-2007, f. &
cert. ef. 8-3-07; OHP 3-2009, f. & cert. ef. 10-1-09; OHP 2-2010(Temp) f. 4-20-10,
cert. ef. 4-21-10 thru 10-17-10; OHP 6-2010, f. 9-23-10, cert. ef. 10-1-10; Renumbered
from 409-030-0065 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 410-121-2065, OPDP 1-2015, f. & cert.
ef. 2-18-15




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