Oregon Administrative Rules › Chapter 410 - OREGON HEALTH AUTHORITY, HEALTH SYSTEMS DIVISION: MEDICAL ASSISTANCE PROGRAMS › Division 121 - PHARMACEUTICAL SERVICES › Section 410-121-0000 - Foreword and Definition of Terms

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The Health Systems Division (Division)
			 Oregon Administrative Rules (OAR) are designed to assist providers in preparing
			 claims for services provided to the Division's fee-for-service clients.
			 Providers must use Pharmaceutical OARs in conjunction with the General Rules
			 OARs (chapter 410, division 120) for Oregon Medical Assistance
			 Programs.
(2) Pharmaceutical
			 services delivered through a managed care plan or a Coordinated Care
			 Organization (CCO) contracted with the Division under the Oregon Health Plan
			 (OHP) are subject to the policies and procedures established in the OHP
			 administrative rules (chapter 410, division 141) and by the specific managed
			 care plan or CCO.
(3) Definition of
			 Terms:
(a) "Actively Practicing" means the
			 active practice of medicine as described in ORS chapter 689 or the active
			 practice of pharmacy as described in ORS chapter 677.
(b) "Authority" means the Oregon Health
			 Authority. See the Oregon Health Authority definition in General Rules (chapter
			 410, division 120);
(c) "Average
			 Manufacturer's Price (AMP)" means the average price that manufacturers sell
			 medication to wholesalers and retail pharmacies, as further clarified in  42 CFR
			 447 ;
(d) "Bulk Dispensing" means
			 multiple doses of medication packaged in one container labeled as required by
			 pertinent federal and state laws and rules;
(e) "Centers for Medicare and Medicaid
			 Services (CMS) Basic Rebate" means the quarterly payment by the manufacturer of
			 a drug pursuant to the manufacturer's CMS Medicaid Drug Rebate Agreement made
			 in accordance with Section 1927(c) of the Social Security Act (42 U.S.C.
			 1396r-8(c)). See
			 410-121-0157;
(f) "CMS Consumer
			 Price Index (CPI) Rebate" means the quarterly payment by the manufacturer
			 pursuant to the manufacturer's CMS Medicaid Drug Rebate Agreement made in
			 accordance with Section 1927(c)(2) of the Social Security Act (42 U.S.C.
			 1396r-8(c));
(g) "Compendia" means those resources widely
			 accepted by the medical profession in the efficacious use of drugs, including
			 the following sources:
(A) The American
			 Hospital Formulary Service Drug information;
(B) The United States Pharmacopeia Drug
			 Information (or its successor publications);
(C) The American Medical Association drug
			 evaluations;
(D) Peer-reviewed
			 medical literature;
(E) Drug
			 therapy information provided by manufacturers of drug products consistent with
			 the federal Food and Drug Administration requirements.
(h) "Community Based Care Living Facility"
			 means for the purposes of the Division's Pharmacy Program, a home, facility, or
			 supervised living environment licensed or certified by the State of Oregon that
			 provides 24-hour care, supervision, and assistance with medication
			 administration. These include but are not limited to:
(A) Supportive living facilities;
(B) Twenty-four hour residential
			 services;
(C) Adult foster
			 care;
(D) Semi-independent living
			 programs;
(E) Assisted living and
			 residential care facilities;
(F)
			 Group homes and other residential services for people with developmental
			 disabilities or needing mental health treatment; and
(G) Inpatient hospice.
(i) "Compounded Prescription" means the
			 following:
(A) A prescription that is
			 prepared at the time of dispensing and involves the weighting of at least one
			 solid ingredient that must be a reimbursable item or a legend drug in a
			 therapeutic amount;
(B) Compounded
			 prescription further defined to include the Oregon Board of Pharmacy definition
			 of compounding (see OAR 855-006-0005).
(j) "Dispensing" means issuance of a
			 prescribed quantity of an individual drug entity by a licensed
			 pharmacist;
(k) "Director" means
			 the director of the Authority;
(l)
			 "Drug Order/Prescription" means the following:
(A) A medical practitioner's written or
			 verbal instructions for a patient's medications; or
(B) A medical practitioner's written order on
			 a medical chart for a client in a nursing facility.
(m) "Durable Medical Equipment and Supplies
			 (DME)" means equipment and supplies as defined in OAR 410-122-0010, Durable
			 Medical Equipment, Prosthetics, Orthotics, and Supplies;
(n) "Intermediate Care Facility" means a
			 facility providing regular health-related care and services to individuals at a
			 level above room and board, but less than hospital or skilled nursing levels as
			 defined in ORS
			 442.015;
(o) "Legend Drug" means a drug limited by
			 Section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act to being
			 dispensed by or upon a medical practitioner's prescription because the drug is:
(A) Habit-forming;
(B) Toxic or having potential for harm;
			 or
(C) Limited in its use to being
			 used under a practitioner's supervision by the new drug application for the
			 drug:
(i) The product label of a legend drug
			 is required to contain the statement: "CAUTION: FEDERAL LAW PROHIBITS
			 DISPENSING WITHOUT A PRESCRIPTION;"
(ii) A legend drug includes prescription
			 drugs subject to the requirement of Section 503(b)(1) of the federal Food,
			 Drug, and Cosmetic Act that shall be exempt from Section 502(F)(1) if certain
			 specified conditions are met.
(p) "Long Term Care Facility" means skilled
			 nursing facilities and intermediate care facilities with the exclusions found
			 in ORS
			 443.400 to
			 443.455;
(q) "Maintenance Medication" means drugs that
			 have a common indication for treatment of a chronic disease, and the
			 therapeutic duration is expected to exceed one year. This is determined by a
			 First DataBank drug code maintenance indicator of "Y" or "1;"
(r) "Mental Health Drug" means a type of
			 legend drug defined by the Oregon Health Authority (Authority) by rule that
			 includes but is not limited to those drugs classified by First DataBank in the
			 following Standard Therapeutic Classes:
(A)
			 Therapeutic Class 7 ataractics-tranquilizers and Therapeutic Class 11
			 psychostimulants-antidepressants;
(B) Depakote, Lamictal, and their generic
			 equivalents and other drugs that the Division specifically carved out from
			 capitation from CCOs, Fully Capitated Health Plans (FCHPs) in accordance with
			 OAR 410-141-3070  and 410-141-0070.
(s) "Narrow Therapeutic Index (NTI) Drug"
			 means a drug that has a narrow range in blood concentrations between efficacy
			 and toxicity and requires therapeutic drug concentration or pharmacodynamic
			 monitoring;
(t) "National Average
			 Drug Acquisition Cost (NADAC)" means the rate that is established by CMS or its
			 contractor by rolling surveys of pharmacies nationwide to verify the actual
			 invoice amount paid by the pharmacy or corporate entity to wholesalers,
			 manufacturers, or distribution centers for the product. The NADAC is the
			 average of invoice amounts for individual drug products based on the Generic
			 Sequence Number (GSN);
(u) "Net
			 Price" means the amount a drug costs the Division and is calculated using the
			 following formula: OR-AAAC, minus CMS Basic Rebate, minus CMS CPI Rebate, minus
			 State Supplemental Rebate;
(v)
			 "Nominal Price" means sales at less than 10 percent of the Average
			 Manufacturer's Price (AMP);
(w)
			 "Non-Preferred Products" means any medication in a class that has been
			 evaluated and that is not listed on the Practitioner-Managed Prescription Drug
			 Plan Preferred Drug List in OAR 410-121-0030;
(x) "Nursing Facility" means an establishment
			 that is licensed and certified by the Department's Aging and People with
			 Disabilities Division (APD) as a Nursing Facility;
(y) "Oregon Average Actual Acquisition Cost
			 (OR-AAAC)" means the rate that is established by the Division or its contractor
			 by rolling surveys of enrolled pharmacies to verify the actual invoice amount
			 paid by the pharmacy or corporate entity to wholesalers, manufacturers, or
			 distribution centers for the product. The AAAC is the average of invoice
			 amounts for individual drug products based on the Generic Sequence Number
			 (GSN);
(z) "Pharmacist" means an
			 individual who is licensed as a pharmacist under ORS chapter 689;
(aa) "Physical Health Drug" means all other
			 drugs not included in the definition of a "mental health drug" according to
			 this rule;
(bb) "Point-of-Sale
			 (POS)" means a computerized, claims submission process for retail pharmacies
			 that provides on-line, real-time claims adjudication;
(cc) "Preferred Drug List (PDL)" means the
			 list of prescription drugs in selected classes that the Authority in
			 consultation with the Pharmacy & Therapeutics Committee (P & T) has
			 determined represent the most effective drugs available at the best possible
			 price. (See details for the Division's PMPDP PDL in OAR 410-121-0030.)The
			 following are two types of preferred drug lists:
(A) "Enforceable Physical Health Preferred
			 Drug List" means the list of "preferred" drug products used to treat physical
			 health conditions. The "preferred" drugs may nevertheless require prior
			 authorization (PA) for clinical reasons. Drugs prescribed that do not appear on
			 the PDL (non-preferred products) shall be subject to PA;
(B) "Voluntary Mental Health Preferred Drug
			 List" means the list of "preferred" drug products used to treat mental health
			 conditions. Any drug prescribed for the treatment of mental health diagnosis
			 shall be exempt from non-clinical PA requirements by the Division.
(dd) "Preferred Products" means
			 products in classes that have been evaluated and placed on the Practitioner
			 Managed Prescription Drug Plan (PMPDP) PDL in OAR 410-121-0030;
(ee) "Prescriber" means any person authorized
			 by law to prescribe drugs;
(ff)
			 "Prescription Splitting" means any one or a combination of the following
			 actions:
(A) Reducing the quantity of a drug
			 prescribed by a licensed practitioner for prescriptions not greater than 34
			 days, except as needed for Prescription Synchronization (see OAR
			 410-121-0146);
(B) Billing the
			 agency for more than one dispensing fee when the prescription calls for one
			 dispensing fee for the quantity billed, except as needed for Prescription
			 Synchronization (see OAR 410-121-0146);
(C) Separating the ingredients of a
			 prescribed drug and billing the agency for separate individual ingredients,
			 with the exception of compounded medications (see OAR 410-121-0146);
			 or
(D) Using multiple 30-day cards
			 to dispense a prescription when a lesser number of cards will
			 suffice.
(gg)
			 "Prescription Synchronization" means the process of, at the client's direction,
			 aligning the refill dates of a client's prescription drugs so drugs that are
			 refilled at the same frequency may be refilled concurrently;
(hh) "Prior Authorization Program (PA)" means
			 the prior authorization program is a system of determining, through a series of
			 therapeutic and clinical protocols, which drugs require authorizations prior to
			 dispensing:
(A) OAR 410-121-0040  lists the
			 drugs or categories of drugs requiring PA;
(B) The practitioner or practitioner's
			 licensed medical personnel listed in OAR 410-121-0060  may request a
			 PA.
(ii) "State
			 Supplemental Rebates" means the Division and CMS approved discounts paid by
			 manufacturers per unit of drug. These rebates are authorized by the Social
			 Security Act section
			 42 USC
			 1396r-8(a)(1) and are in
			 addition to federal rebates mandated by the Omnibus Budget Rehabilitation Act
			 (OBRA 90) and the federal rebate program;
(jj) "Unit Dose" means a sealed, single unit
			 container of medication so designed that the contents are administered to the
			 patient as a single dose, direct from the container, and dispensed following
			 the rules for the unit dose dispensing system established by the Oregon Board
			 of Pharmacy;
(kk) "Urgent Medical
			 Condition" means a medical condition that arises suddenly, is not
			 life-threatening, and requires prompt treatment to avoid the development of
			 more serious medical problems;
(ll)
			 "Usual and Customary Price" means a pharmacy's charge to the general public
			 that reflects all advertised savings, discounts, special promotions, or other
			 programs including membership based discounts initiated to reduce prices for
			 product costs available to the general public, a special population, or an
			 inclusive category of customers;
(mm) "Wholesale Acquisition Cost (WAC)" means
			 the price paid by a wholesaler for drugs purchased from the wholesaler's
			 supplier, typically the manufacturer of the drug. WAC is the price of a covered
			 product by the National Drug Code (NDC) as published by First DataBank,
			 MediSpan, or Red Book;
(nn) "340B
			 Pharmacy" means a federally designated community health center or other
			 federally qualified covered entity that is listed on the Health Resources and
			 Services Administration (HRSA) website.