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Oregon Bulletin

March 1, 2011

 

Oregon Health Authority,
Division of Medical Assistance Programs
Chapter 410

Rule Caption: Renumber of Oregon Prescription Drug Program rules.

Adm. Order No.: DMAP 1-2011

Filed with Sec. of State: 2-10-2011

Certified to be Effective: 3-1-11

Notice Publication Date:

Rules Renumbered: 409-030-0000 to 410-121-2000, 409-030-0005 to 410-121-2005, 409-030-0010 to 410-121-2010, 409-030-0020 to 410-121-2020, 409-030-0030 to 410-121-2030, 409-030-0050 to 410-121-2050, 409-030-0065 to 410-121-2065

Subject: Renumber of Oregon Prescription Drug Program rules to update references consistent with agency organization from the Office of Oregon Health Policy and Research (409) to the Division of Medical Assistance Programs (410).

Rules Coordinator: Darlene Nelson—(503) 945-6927

410-121-2000

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) “Critical Access Pharmacy (CAP)” means a sole Oregon pharmacy in a community within a ten-mile radius from other pharmacies. If a pharmacy’s ten-mile radius intersects with another sole pharmacy’s ten-mile radius, both shall be considered a CAP if either pharmacy’s closure could result in impaired access for rural communities.

(4) “Department” means the Department of Human Services.

(5) “Designated Entity” means an entity contracted by the Department to perform administrative duties of the program including but not limited to determining program prices, processing and paying claims, issuing identification cards, maintaining eligibility files, 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) “Group Enrollee” means any individual who is issued an OPDP identification card through a participating group.

(7) “Group Purchasing Organization (GPO)” means any organization purchasing on a group basis for purchasers whose drug purchasing is exempt from the federal price discrimination law known as the Robinson Patman Act, 15 USC 13 and satisfies the Nonprofit Institutions Act, 15 USC 13c, or is that of a governmental entity performing traditional government functions.

(8) “Enrollee” means an individual who meets the eligibility requirements of the OPDP according to ORS 414.312(e), pays the applicable enrollment fee, and is issued an enrollment card.

(9) “Participating Group” means agencies or institutions eligible to participate in the OPDP according to ORS 414.312(4).

(10) “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.

(11) “Pharmacy Provider” means retail drug outlets that volunteer to participate in the OPDP and that contract with the Department or a designated entity as a pharmacy provider.

(12) “Prescription Drug” means drugs whose sale without a prescription is prohibited by law.

(13) “Prescription Drug Claims Processor” means an entity that processes and pays prescription drug claims, transmits prescription drug prices and claims data between pharmacies and the OPDP, and processes payments to pharmacies.

(14) “Program Price” means the reimbursement rates and prescription drug prices established by the OPDP Administrator directly or through a contract with a designated entity, including program cost, dispensing fee, and all applicable manufacturers discounts and rebates.

(15) “Rebate” means promotional or volume related refunds pre-arranged with manufacturers on certain prescription drugs used to reduce the cost to the purchaser.

(16) “Replenishment Administration” means tracking GPO or 340B program usage by pharmacy 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.

(17) “Third Party Administrator (TPA)” means an entity that, in addition to being a prescription drug claims processor, 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 groups; maintaining enrollment and issuing identification cards; and processing payments to pharmacies. The TPA may be contracted through the Department 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

410-121-2005

General Administration

(1) The Administrator, or designee, may:

(a) Negotiate price discounts and rebates on prescription drugs with prescription drug manufacturers;

(b) Purchase prescription drugs on behalf of enrollees and participating groups;

(c) Contract with a prescription drug claims processor or PBM to adjudicate pharmacy claims and transmit program prices to pharmacies;

(d) Determine program prices and reimburse pharmacies for prescription drugs;

(e) Adopt and implement a preferred drug list for the program;

(f) Develop a system for allocating and distributing the operational costs of the program and any rebates obtained to participants of the program; and

(g) Cooperate with any state or regional consortia in bulk purchasing of prescription drugs.

(2) The Administrator shall oversee the implementation of the OPDP, including review of enrollee eligibility information, participating group 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 group, including entities otherwise subject to ORS 731.036(6).

(4) The Administrator may contract with a pharmacy benefit manager directly or indirectly for pharmacy networks that provide statewide access for OPDP members including consideration for CAP providers.

(5) The Administrator may contract with replenishment administrators, GPO’s or 340B 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.

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

410-121-2010

Pharmacy Providers

(1) The pharmacy shall contract with the Department, or its designated entity, and must be licensed with their state Board of Pharmacy to be a pharmacy provider under the OPDP.

(2) The pharmacy provider shall 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 to serve enrollees 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 the Oregon Board of Pharmacy; and

(c) Approval of the contract by the Department 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 including but not limited to dispensing fees which may be charged to the enrollee;

(b) Maintain sufficient documentation of transactions to resolve disagreements with the enrollee about the amount charged for the prescription drugs;

(c) Reimburse the enrollee or participating group 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 enrollees for costs incurred by the pharmacy provider for the electronic transmittal of the program price from the Department to the pharmacy.

(5) Pharmacy providers may advertise participation in the OPDP;

(a) Advertising or marketing materials must be accurate and not misleading or confusing to enrollees 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 Department suspends or terminates the contract.

(6) The Administrator 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

410-121-2020

Program Price

(1) The price for a prescription drug a pharmacy provider may charge an enrollee 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 enrollee, except as otherwise provided in section (7) of this rule.

(4) Prescription drug benefits shall be outlined on enrollee and group enrollee 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) Certain participating groups may receive the program price based on other reimbursement arrangements with the OPDP, where the prescription drug is not being dispensed by a pharmacy provider to a group enrollee. The designated entity shall approve and arrange such reimbursement.

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

410-121-2030

Preferred Drug List

(1) The Office for Oregon Health Policy and Research shall develop and recommend to the Administrator a PDL 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 groups.

(2) The OPDP shall develop a PDL that participating groups 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 group uses the PDL developed by the OPDP, it must be used in conjunction with that group’s benefit plan including all pharmacy management programs the group has or adopts.

(4) The PDL shall also be made 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

410-121-2050

Enrollment

(1) Participating groups shall enroll for participation through the designated entity chosen by the OPDP to administer the participating group’s enrollment and claims processing.

(a) Eligibility for group enrollees of a participating group shall be maintained electronically between the group and designated entity.

(b) Participating groups shall issue identification cards to group enrollees at initial enrollment and renewal, and to group enrollees 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 enrollees.

(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

410-121-2065

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 Department’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 Department’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 Department’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 409.050 & 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

Notes
1.) This online version of the OREGON BULLETIN is provided for convenience of reference and enhanced access. The official, record copy of this publication is contained in the original Administrative Orders and Rulemaking Notices filed with the Secretary of State, Archives Division. Discrepancies, if any, are satisfied in favor of the original versions. Use the OAR Revision Cumulative Index found in the Oregon Bulletin to access a numerical list of rulemaking actions after November 15, 2010.

2.) Copyright 2011 Oregon Secretary of State: Terms and Conditions of Use

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