Washington Administrative Code › Title 182 - Health Care Authority › WASHINGTON APPLE HEALTH › Chapter 182-530 - Prescription drugs (outpatient) › Section 182-530-1050 - Definitions

Current through Register Vol. 24-14, July 15, 2024
In addition to the definitions and abbreviations found in
				  chapter 182-500 WAC, Medical definitions, the following definitions apply to
				  this chapter.
"340B program"
- The federal program that
				  requires drug manufacturers participating in the medicaid drug rebate program
				  (MDRP) to provide covered outpatient drugs to enrolled "covered entities" at or
				  below the ceiling price, as described in
				  42 U.S.C. §
										256b. This requirement is described in
				  section 340B of the Public Health Service Act and codified in
				  42 U.S.C. §
										256b.
"340B provider"
or
"PHS-qualified covered
				  entity"
- Any provider including, but not limited to, a clinic,
				  facility, hospital, pharmacy, or program listed in
				  42 U.S.C. §
										256b as eligible to purchase, dispense, or
				  administer outpatient drugs through the 340B program, has submitted its valid
				  medicaid provider number(s) or national provider identification (NPI) number to
				  the public health service (PHS), health resources and services administration
				  (HRSA), office of pharmacy affairs (OPA), and has registered with and been
				  approved by OPA.
"340B maximum allowable cost (340B MAC)"
- The
				  maximum amount the medicaid agency reimburses a participating 340B public
				  health services (PHS)-qualified covered entity to purchase, dispense, or
				  administer a covered outpatient drug, device, or drug-related supply.
"Active ingredient"
- The chemical component of
				  a drug responsible for a drug's prescribed/intended therapeutic effect. The
				  medicaid agency or the agency's designee limits coverage of active ingredients
				  to those with an 11-digit national drug code (NDC) and those specifically
				  authorized by the agency or the agency's designee.
"Actual acquisition cost (AAC)"
- The true cost
				  paid for a specific drug or product in the package size purchased, including
				  discounts, rebates, charge backs that affect the provider's invoice price, and
				  other adjustments to the price of the drug, device, or drug-related supply,
				  excluding dispensing fees.
"Administer"
- Includes the direct application
				  of a prescription drug or device by injection, insertion, inhalation,
				  ingestion, or any other means, to the body of a patient by a practitioner, or
				  at the direction of the practitioner.
"Appointing authority"
- The following people
				  acting jointly: The director of the Washington state health care authority and
				  the director of the Washington state department of labor and industries.
"Authorized generic drug"
- Any drug sold,
				  licensed, or marketed under a new drug application (NDA) approved by the Food
				  and Drug Administration (FDA) under section 505(c) of the Federal Food, Drug
				  and Cosmetic Act (FFDCA) that is marketed, sold or distributed under a
				  different labeler code, product code, trade name, trademark, or packaging
				  (other than repackaging the listed drug for use in institutions) than the brand
				  name drug.
"Automated authorization"
- Adjudication of
				  claims using submitted NCPDP data elements or claims history to verify that the
				  medicaid agency's or its designee's authorization requirements have been
				  satisfied without the need for the medicaid agency or its designee to request
				  additional clinical information.
"Average manufacturer price (AMP)"
- The average
				  price paid to a manufacturer by wholesalers for drugs distributed to retail
				  pharmacies.
"Average sales price (ASP)"
- The weighted
				  average of all nonfederal sales to wholesaler's net of charge backs, discounts,
				  rebates, and other benefits tied to the purchase of the drug product, whether
				  it is paid to the wholesaler or the retailer.
"Average wholesale price (AWP)"
- A reference
				  price of a drug product that is published at a point in time and reported to
				  the medicaid agency or its designee by the agency's drug file
				  contractor.
"Brand name drug"
- A single-source or innovator
				  multiple-source drug.
"Compendia of drug information"
- Includes the
				  following:
(1) The American Hospital
				Formulary Service Drug Information;
(2) The United States Pharmacopeia Drug
				Information; and
(3) DRUGDEX
				Information System.
"Compounding"
- The act of combining two or more
				  active ingredients or adjusting therapeutic strengths in the preparation of a
				  prescription.
"Deliver or delivery"
- The transfer of a drug
				  or device from one person to another.
"Dispense as written (DAW)"
- An instruction to
				  the pharmacist forbidding substitution of a generic drug or a therapeutically
				  equivalent product for the specific drug product prescribed.
"Dispensing fee"
- Means professional dispensing
				  fee. See professional dispensing fee.
"Drug file"
- A list of drug products, pricing
				  and other information provided to the medicaid agency or its designee and
				  maintained by a drug file contractor.
"Drug file contractor"
- An entity which has
				  been contracted to provide regularly updated information on drugs, devices, and
				  drug-related supplies at specified intervals, for the purpose of pharmaceutical
				  claim adjudication. Information is provided specific to individual national
				  drug codes, including product pricing.
"Drug-related supplies"
- Nondrug items
				  necessary for the administration, delivery, or monitoring of a drug or drug
				  regimen.
"Drug use review (DUR)"
- A review of covered
				  outpatient drug use that assures prescriptions are appropriate, medically
				  necessary, and not likely to result in adverse medical outcomes.
"Effectiveness"
- The extent to which a given
				  intervention is likely to produce beneficial results for which it is intended
				  in ordinary circumstances.
"Efficacy"
- The extent to which a given
				  intervention is likely to produce beneficial effects in the context of the
				  research study.
"Emergency kit"
- A set of limited
				  pharmaceuticals furnished to a nursing facility by the pharmacy that provides
				  prescription dispensing services to that facility. Each kit is specifically set
				  up to meet the emergency needs of each nursing facility's client population and
				  is for use during those hours when pharmacy services are unavailable.
"Endorsing practitioner"
- A practitioner who
				  has reviewed the Washington preferred drug list (Washington PDL) and has
				  enrolled with the health care authority (HCA), agreeing to allow therapeutic
				  interchange (substitution) of a preferred drug for any nonpreferred drug in a
				  given therapeutic class on the Washington PDL.
"Estimated acquisition cost (EAC)"
- The
				  medicaid agency's estimate of the price providers generally and currently pay
				  for a drug marketed or sold by a particular manufacturer or labeler.
"Evidence-based drug reviews"
- The application
				  of a set of principles and methods for comprehensive independent and objective
				  evaluation of clinical evidence provided in well-designed and well-conducted
				  studies and objective clinical data to determine the level of evidence that
				  proves to the greatest extent possible, that a health care service is safe,
				  effective, and beneficial when making population-based coverage policies or
				  individual medical necessity decisions. Classifying evidence by its
				  epistemologic strength and requiring that only the strongest types (coming from
				  meta-analyses, systematic reviews, and randomized controlled trials) can yield
				  strong recommendations; weaker types (such as from case-control studies) can
				  yield weak recommendations.
"Evidence-based practice center"
or
"EPC"
- A research organization that has been designated by the
				  Agency for Healthcare Research and Quality (AHRQ) to develop evidence reports
				  and technology assessments on topics relevant to clinical and other health care
				  organization and delivery issues, specifically those that are common,
				  expensive, or significant for the medicare and medicaid populations.
"Federal drug rebates"
- Dollars returned to
				  medicaid from pharmaceutical manufacturers under the terms of the
				  manufacturers' national rebate agreement with the federal Department of Health
				  and Human Services (DHHS).
"Federal upper limit (FUL)"
- The maximum
				  allowable reimbursement set by the Centers for Medicare and Medicaid Services
				  (CMS) for a multiple-source drug.
"Generic drug"
- A drug that is approved by the
				  Food and Drug Administration (FDA) under an abbreviated new drug
				  application.
"Inactive ingredient"
- A drug component that
				  remains chemically unchanged during compounding but serves as the:
(1) Necessary vehicle for the delivery of the
				therapeutic effect; or
(2) Agent
				for the intended method or rate of absorption for the drug's active therapeutic
				agent.
"Ingredient cost"
- The portion of a
				  prescription's cost attributable to the covered drug ingredients or chemical
				  components.
"Innovator multiple-source drug"
- A
				  multiple-source drug that was originally marketed under a new drug application
				  (NDA) approved by the Food and Drug Administration (FDA), including an
				  authorized generic drug. This includes:
(1) A drug product marketed by any
				cross-licensed producers, labelers, or distributors operating under the NDA;
				or
(2) A covered outpatient drug
				approved under a biologics license application (BLA), product license
				application (PLA), establishment license application (ELA), or antibiotic drug
				application (ADA).
"Less than effective drug"
or
"DESI"
- A drug for which:
(1) Effective approval of the drug
				application has been withdrawn by the Food and Drug Administration (FDA) for
				safety or efficacy reasons as a result of the drug efficacy study
				implementation (DESI) review; or
(2) The secretary of the federal Department
				of Health and Human Services (DHHS) has issued a notice of an opportunity for a
				hearing under section 505(e) of the federal Food, Drug, and Cosmetic Act on a
				proposed order of the secretary to withdraw approval of an application for such
				drug under such section because the secretary has determined the drug is less
				than effective for some or all conditions of use prescribed, recommended, or
				suggested in its labeling.
"Maximum allowable cost (MAC)"
- The maximum
				  amount the medicaid agency or its designee reimburses for a drug, device, or
				  drug-related supply.
"Medicaid preferred drug list (medicaid PDL)"
-
				  The list of all drugs in drug classes approved for inclusion by the Washington
				  medic-aid drug use review (DUR) board and each drug's preferred or nonpreferred
				  status as approved by the agency director or designee. The list includes at
				  minimum all drugs and drug classes on the Washington PDL and may include
				  additional drugs and drug classes recommended by the DUR board and approved by
				  the agency director or designee.
"Medically accepted indication"
- Any use for a
				  covered outpatient drug:
(1) Which is
				approved under the federal Food, Drug, and Cosmetic Act; or
(2) The use of which is supported by one or
				more citations included or approved for inclusion in any of the compendia of
				drug information, as defined in this chapter.
"Modified unit dose delivery system"
(also known
				  as blister packs or "bingo/punch cards") - A method in which each patient's
				  medication is delivered to a nursing facility:
(1) In individually sealed, single dose
				packages or "blisters"; and
(2) In
				quantities for one month's supply, unless the prescriber specifies a shorter
				period of therapy.
"Multiple-source drug"
- A drug for which there
				  is at least one other drug product sold in the United States that is
				  pharmaceutically equivalent and bioequivalent, as determined by the Food and
				  Drug Administration (FDA).
"National drug code (NDC)"
- The 11-digit
				  numerical code that includes the labeler code, product code, and package
				  code.
"National rebate agreement"
- The agreement
				  developed by the Centers for Medicare and Medicaid Services (CMS) to implement
				  section 1927 of the Social Security Act, and entered into by a manufacturer and
				  the federal Department of Health and Human Services (DHHS).
"Noninnovator multiple-source drug"
- A drug
				  that is:
(1) A multiple-source drug
				that is not an innovator multiple-source drug or a single-source
				drug;
(2) A multiple-source drug
				marketed under an abbreviated new drug application (ANDA) or an abbreviated
				antibiotic drug application;
(3) A
				covered outpatient drug that entered the market before 1962 and was originally
				marketed under a new drug application (NDA); or
(4) Any drug that has not gone through a Food
				and Drug Administration (FDA) approval process but otherwise meets the
				definition of a covered outpatient drug.
If any of the drug products listed in this definition of a
				  noninnovator multiple-source drug subsequently receive an NDA or ANDA approval
				  from the FDA, the product's drug category changes to correlate with the new
				  product application type.
"Nonpreferred drug"
- A drug within a
				  therapeutic class of drugs on the medicaid preferred drug list (medicaid PDL)
				  that has not been selected as a preferred drug.
"Obsolete NDC"
- A national drug code replaced
				  or discontinued by the manufacturer or labeler.
"Over-the-counter (OTC) drugs"
- Drugs that do
				  not require a prescription before they can be sold or dispensed.
"Peer reviewed medical literature"
- A research
				  study, report, or findings regarding the specific use of a drug that has been
				  submitted to one or more professional journals, reviewed by experts with
				  appropriate credentials, and subsequently published by a reputable professional
				  journal. A clinical drug study used as the basis for the publication must be a
				  double blind, randomized, placebo or active control study.
"Pharmacist"
- A person licensed in the practice
				  of pharmacy by the state in which the prescription is filled.
"Pharmacy"
- Every location licensed by the
				  state board of pharmacy in the state where the practice of pharmacy is
				  conducted.
"Pharmacy and therapeutic (P&T) committee"
-
				  The independent Washington state committee created by
				  RCW
				  41.05.021 (1)(a)(iii)  and
				  70.14.050. At the election of the
				  medicaid agency or its designee, the committee may serve as the drug use review
				  board provided for in WAC
				  182-530-4000.
"Point-of-sale (POS)"
- A pharmacy claims
				  processing system capable of receiving and adjudicating claims online.
"Practice of pharmacy"
- The practice of and
				  responsibility for:
(1) Accurately
				interpreting prescription orders;
(2) Compounding drugs;
(3) Dispensing, labeling, administering, and
				distributing of drugs and devices;
(4) Providing drug information to the client
				that includes, but is not limited to, the advising of therapeutic values,
				hazards, and the uses of drugs and devices;
(5) Monitoring of drug therapy and
				use;
(6) Proper and safe storage of
				drugs and devices;
(7) Documenting
				and maintaining records;
(8)
				Initiating or modifying drug therapy in accordance with written guidelines or
				protocols previously established and approved for a pharmacist's practice by a
				practitioner authorized to prescribe drugs; and
(9) Participating in drug use reviews and
				drug product selection.
"Practitioner"
- An individual who has met the
				  professional and legal requirements necessary to provide a health care service,
				  such as a physician, nurse, dentist, physical therapist, pharmacist, or other
				  person authorized by state law as a practitioner.
"Preferred drug"
- A drug within a therapeutic
				  class of drugs on the medicaid preferred drug list (medicaid PDL) that has been
				  selected as a preferred drug.
"Prescriber"
- A physician, osteopathic
				  physician/surgeon, dentist, nurse, physician assistant, optometrist,
				  pharmacist, or other person authorized by law or rule to prescribe drugs. See
				  WAC 246-863-100 for pharmacists' prescriptive authority.
"Prescription"
- An order for drugs or devices
				  issued by a practitioner authorized by state law or rule to prescribe drugs or
				  devices, in the course of the practitioner's professional practice, for a
				  legitimate medical purpose.
"Prescription drugs"
- Drugs required by any
				  applicable federal or state law or regulation to be dispensed by prescription
				  only or that are restricted to use by practitioners only.
"Professional dispensing fee":
(1) The fee the medicaid agency or its
				designee pays pharmacists and dispensing providers for covered prescriptions.
				The fee pays for costs in excess of the ingredient cost of a covered outpatient
				drug when a covered outpatient drug is dispensed; and
(2) Includes only costs associated with
				ensuring that possession of the appropriate covered outpatient drug is
				transferred to a medic-aid beneficiary. Pharmacy and dispensing provider costs
				include, but are not limited to, reasonable costs associated with a
				prescriber's time in checking the computer for information about an
				individual's coverage, performing drug utilization review and preferred drug
				list review activities, measurement or mixing of the covered outpatient drug,
				filling the container, beneficiary counseling, physically providing the
				completed prescription to the medicaid beneficiary, delivery, special
				packaging, and overhead associated with maintaining the facility and equipment
				necessary to operate the dispensing entity.
"Prospective drug use review (Pro-DUR)"
- A
				  process in which a request for a drug product for a particular client is
				  screened, before the product is dispensed, for potential drug therapy
				  problems.
"Reconstitution"
- The process of returning a
				  single active ingredient, previously altered for preservation and storage, to
				  its approximate original state. Reconstitution is not compounding.
"Retrospective drug use review (Retro-DUR)"
-
				  The process in which drug utilization is reviewed on an ongoing periodic basis
				  to identify patterns of fraud, abuse, gross overuse, or inappropriate or not
				  medically necessary care.
"Single-source drug"
- A drug produced or
				  distributed under an original new drug application (NDA) approved by the Food
				  and Drug Administration (FDA) with an approved new drug application (NDA)
				  number issued by the FDA. This includes:
(1) A drug product marketed by any
				cross-licensed producers, labelers, or distributors operating under the NDA;
				or
(2) A drug approved under a
				biologics license application (BLA), product license application (PLA),
				establishment license application (ELA), or antibiotic drug application (ADA).
For the purposes of this definition, an ANDA is not an
				  NDA.
"Systematic review"
- A specific and
				  reproducible method to identify, select, and appraise all the studies that meet
				  minimum quality standards and are relevant to a particular question. The
				  results of the studies are then analyzed and summarized into evidence tables to
				  be used to guide evidence-based decisions.
"Terminated NDC"
- An 11-digit national drug
				  code (NDC) that is discontinued by the manufacturer for any reason. The NDC may
				  be terminated immediately due to health or safety issues or it may be phased
				  out based on the product's shelf life.
"Therapeutic alternative"
- A drug product that
				  contains a different chemical structure than the drug prescribed, but is in the
				  same pharmacologic or therapeutic class and can be expected to have a similar
				  therapeutic effect and adverse reaction profile when administered to patients
				  in a therapeutically equivalent dosage.
"Therapeutic class"
- A group of drugs used for
				  the treatment, remediation, or cure of a specific disorder or disease.
"Therapeutic interchange"
- To dispense a
				  therapeutic alternative to the prescribed drug when an endorsing practitioner
				  who has indicated that substitution is permitted, prescribes the drug. See
				  therapeutic interchange program (TIP).
"Therapeutic interchange program (TIP)"
- The
				  process developed by participating state agencies under
				  RCW
				  69.41.190 and
				  70.14.050, to allow prescribers to
				  endorse a Washington preferred drug list, and in most cases, requires
				  pharmacists to automatically substitute a preferred, equivalent drug from the
				  list.
"Therapeutically equivalent"
- Drug products
				  that contain different chemical structures but have the same efficacy and
				  safety when administered to an individual, as determined by:
(1) Information from the Food and Drug
				Administration (FDA);
(2) Published
				and peer-reviewed scientific data;
(3) Randomized controlled clinical trials;
				or
(4) Other scientific
				evidence.
"Tiered dispensing fee system"
- A system of
				  paying pharmacies different dispensing fee rates, based on the individual
				  pharmacy's total annual prescription volume and/or the drug delivery system
				  used.
"True unit dose delivery"
- A method in which
				  each patient's medication is delivered to the nursing facility in quantities
				  sufficient only for the day's required dosage.
"Unit dose drug delivery"
- True unit dose or
				  modified unit dose delivery systems.
"Usual and customary charge"
- The fee that the
				  provider typically charges the general public for the product or
				  service.
"Washington preferred drug list (Washington
				  PDL)"
- The list of drugs selected by the appointing authority to be
				  used by applicable state agencies as the basis for purchase of drugs in
				  state-operated health care programs.
"Wholesale acquisition cost"
- Refers to either
				  the actual wholesale cost paid by a wholesaler for drugs purchased from a
				  manufacturer or a list price published as wholesale acquisition
				  cost.
Statutory Authority:
					 RCW
					 41.05.021 and section 1927 of the Social
					 Security Act. WSR 12-18-062, §
											182-530-1050, filed 8/31/12,
					 effective 10/1/12. WSR 11-14-075, recodified as §
											182-530-1050, filed 6/30/11,
					 effective 7/1/11. Statutory Authority:
					 RCW
					 74.04.050,
					 74.08.090,
					 74.09.700, 2008 c 245. WSR
					 08-21-107, § 388-530-1050, filed 10/16/08, effective 11/16/08. Statutory
					 Authority:
					 RCW
					 74.04.050,
					 74.08.090,
					 74.09.530, and
					 74.09.700. WSR 07-20-049, §
					 388-530-1050, filed 9/26/07, effective 11/1/07. Statutory Authority:
					 RCW
					 74.08.090,
					 70.14.050,
					 69.41.150,
					 69.41.190,
					 chapter
					 41.05 RCW. WSR 05-02-044,
					 § 388-530-1050, filed 12/30/04, effective 1/30/05. Statutory Authority:
					 RCW
					 74.09.080,
					 74.04.050 and 42 C.F.R. Subpart K,
					 subsection 162.1102. WSR 02-17-023, § 388-530-1050, filed 8/9/02,
					 effective 9/9/02. Statutory Authority:
					 RCW
					 74.08.090,
					 74.04.050. WSR 01-24-066, §
					 388-530-1050, filed 11/30/01, effective 1/2/02; WSR 01-01-028, §
					 388-530-1050, filed 12/7/00, effective 1/7/01. Statutory Authority:
					 RCW
					 74.08.090. WSR 96-21-031, §
					 388-530-1050, filed 10/9/96, effective
					 11/9/96.