Term

1.

Definition Acute care is a branch of secondary health care where a patient receives active but short-term treatment for a severe injury or episode of illness, an urgent medical condition, or during recovery from surgery. In medical terms, care for acute health conditions is the opposite from chronic care, or longer term care. Acute care services are generally delivered by teams of health care professionals from a range of medical and surgical specialties. Acute care may require a stay in a hospital emergency department, ambulatory surgery center, urgent care center or other short-term stay facility, along with the assistance of diagnostic services, surgery, or follow-up outpatient care in the community. Hospital-based acute inpatient care typically has the goal of discharging patients as soon as they are deemed healthy and stable. Acute care settings include but are not limited to: emergency department, intensive care, coronary care, cardiology, neonatal intensive care, and many general areas where the patient could become acutely unwell and require stabilization and transfer to another higher dependency unit for further treatment. Adherence describes the degree to which a patient correctly follows medical advice or, in the case of a prescription, the patient obtains / purchases the prescribed medication in a timely fashion. Ancillary products mean products or equipment necessary to administer a Specialty Medication (needles, syringes, alcohol swabs, sharps containers, infusion related supplies, other medical supplies, etc.). Assignment of Benefits (AOB) is a legally binding agreement between the patient and their insurance company that authorizes the patients reimbursement money to be sent directly to their health care provider from the insurance company. Often used by SPPs as an alternative to buy and bill for physician clinics that do not want to take on the risk of seeing reimbursement for dispensed product.

Acute Care

2.

Adherence

3.

Ancillary Products

4.

Assignment of Benefits (AOB)

5.

ASP

Average Sales Price (ASP) is a reimbursement methodology introduced by the Medicare Modernization Act of 2003. It requires a manufacturer to report actual sales figures (to CMS within 30 days of the close of the quarter every calendar quarter) net of any discounts, rebates, free goods, etc. Manufacturers must complete the ASP Certification Form (Addendum B) to certify that their data submissions are accurate, true, and current. CMS uses these reports to recalculate drug reimbursement to eligible providers on a quarterly basis using the then in force multiplier (e.g., ASP = +6%). That price is used to reimburse providers for dispensed products under Medicare Part B and for other payors that have adopted the same reimbursement methodology. (also see Pricing) Average Wholesale Price means the published price of a drug on the date the prescription is dispensed by a Provider based on the Medi-Span Electronic Drug File. Medi-Span is a codified drug dictionary, drug vocabulary, and drug pricing index for prescription drugs and includes Product names , Dose form Route of administration, Strength, Proprietary drug identifiers, including Generic Product Identifier (GPI), Drug Descriptor Identifier (DDID) and the Generic Product Packaging Code (GPPC), Pricing files, Average Wholesale Price (AWP), Wholesale Acquisition Price (WAC). Direct Price (DP), Centers for Medicare & Medicaid Services, Federal Upper Limit (CMS FUL), Average Average Wholesale Price (AAWP), and Generic Equivalent Average Price (GEAP) (also see Pricing) Basic Compliance Program means refill follow-up to promote timely shipment and encourage continuity off therapy (call/text/email). May or may not be accompanied by patient counseling.

6.

AWP

7.

Basic Compliance Program

8.

Benefits Investigation / Benefits verification

Benefits Investigation / Benefits Verification (terms used interchangeably) - The process of confirming the patients benefits, applicable deductibles and/or copayments by contacting the health insurer / payor of record or through online verification of eligibility and benefit levels.

9.

Biologics

Biologics are biologic medical products, or more simply as a biologic or biological, is a medicinal product such as a vaccine, blood or blood component, allergenic, somatic cell, gene therapy, tissue, recombinant therapeutic protein, or living cells that are used as therapeutics to treat diseases. Biologics are created by biologic processes, rather than being chemically synthesized. Biosimilars, also known as follow-on biologics, are biologic products whose active drug substances are made from a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods. Biosimilars, or follow-on biologics, are terms used to describe officially-approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Biosimilars require a full FDA review process prior to approval for marketing and must successfully pass rigorous trials to obtain an interchangeable rating with the innovator product. Brand Name Drug means an FDA approved and prescribed drug designated as brand according to the FDA, or another mutually agreed upon nationally recognized source. A brand-name drug product is originally discovered and developed by a pharmaceutical company. In order for the company to market and sell their product they must first gain approval from the Food and Drug Administration (FDA) by submitting a New Drug Application. In this documentation the company submits data to establish a drug's clinical safety and efficacy. Other studies determine the characteristics of the drug dosage form, including the manufacturing process, drug stability, purity, strength, and how it dissolves. Once the drug receives FDA approval, the innovator company can then exclusively market and sell this 'brand-name' product for as long as the company has patent protection.

10.

Biosimilar

11.

Brand Name Drug

12.

Brown Bagging

Brown Bagging refers to a specialty medication dispensed directly to patients who then carry the product to a physicians office clinic, etc. for administration by a physician or licensed clinician. Buy and Bill is a reimbursement process whereby a physician (or clinic, etc.) purchase medicine for administration by a physician or clinician. Once administered, medications are typically billed by the physician to the patient or the patients payor of record for the cost of the drug plus a markup (fee schedule).

13.

Buy and Bill

14.

Class of Trade

Class of Trade means a customer category for which a business may be eligible and for which specific pricing is assigned by a manufacturer. As pertains to drugs, various classes of trade include, but are not limited to physicians, hospitals, clinics & other health facilities, and pharmacies. Each class may be assigned a unique price for a specific product as deemed by the manufacturer. Clean Claim means a claim for a medical procedure, drug, or other request for payment that meets all minimum criteria for payment by a payor with no further documentation required. Closed Door Pharmacy means a licensed specialty pharmacy that ships prescriptions to patients with no general public access. Pharmaceutical manufacturers may require that a specialty pharmacy be Closed Door as an eligibility criterion for access to a particular drug or program. Coordination of Benefits (COB) means the process of determining and reconciling individual payor liability for reimbursement when a patient is eligible for benefits coverage under more than one insurance company or other payor type (e.g., Medicare / Medicaid). Terms and conditions within the Summary of Benefits for each plan will generally dictate which payor is primary or secondary and any mathematical formula associated for calculating each payors portion of coverage. Coinsurance is the patients financial liability as a percentage of the payers total reimbursement for a service or drug, after any applicable deductible is met and usually up to a certain limit (e.g., $2000 annually). It must be paid before any policy benefit is payable by the insurance company or payor of record. Copayments may or may not contribute towards any policy out-of-pocket maximums. Cold Chain Handling means a process that ensures adherence to storage conditions according to the requirements identified on the FDA approved drug label (e.g., must be stored at Refrigerated storage 2-8 degrees C, 36-46 degrees F) throughout the distribution process (i.e., from manufacturer, to distributor, to pharmacy, to patient or physician ) which includes medium (e.g., ice, gel packs, etc.) and a means to measure adherence.

15.

Clean Claim

16.

Closed Door Pharmacy

17.

COB

18.

Coinsurance

19.

Cold Chain Handling

20.

Contract Price

Contract Price in contract law is a material term and means the price for the goods or services to be received / provided in the contract. The contract price helps to determine whether a contract may exist. Upon litigation, if the contract price is not included in the written contract, the court may hold that a contract did not exist. In litigation, the contract price is a factor for determining damages upon a party forsaking its contractual obligations. The contract price as a point of reference may help determine the expectancy interest of the party suffering damages as well as the reliance interest along with damages under promissory estoppel. Compliance describes the degree to which a patient faithfully complies with the dosing instructions as specified by a prescribing physician consistent with the products FDA approved label. Compounded Medication means the professional practice of extemporaneous compounding includes the creation of customized medications (dose adjusted, alternate forms, etc.) from FDA approved chemical ingredients for patients whose healthcare needs cannot be met by FDA regulated and manufactured medications, or medications that are no longer in production. Controlled Access occurs when a manufacturer sells product to a limited number of licensed specialty distributors and / or a limited number of specialty pharmacies directly for sale to specific classes-of-trade and dispensing to patients respectively, under a program services agreement Controlled Distribution exists when a manufacturer sets specific criteria for specialty pharmacy vendors to be eligible to purchase a drug (e.g., training, facilities, storage, distribution, shipping & handling, etc.) Copayment (or copay) is the patients financial liability as defined by the insurance carrier or payer of record in the patients Summary of Benefits. It is technically a form of coinsurance, but is defined differently in health insurance where a coinsurance is a percentage payment after the deductible up to a certain limit. It must be paid before any policy benefit is payable by an insurance company. Copayments may or may not contribute towards any policy out-of-pocket maximums.

21.

Compliance

22.

Compounded Medication

23.

Controlled Access

24.

Controlled Distribution

25.

Copayment

26.

Covered Services

Covered Services means those Medically Necessary pharmaceutical services provided under the terms of this Agreement including Prescription Biologicals, Drugs and Medications normally provided by a Pharmacy to its patients, excluding those pharmacy services which are not benefits for Members under a Certificate of Coverage, provided that all services are furnished by a Pharmacy only upon order of a Physician or other licensed provider authorized to prescribe medications within the limits of their licensure (may include PAs, RNs, Dentists, etc.).

27.

Diagnostic Test / Companion Diagnostic Test is any kind of medical test performed to aid in the diagnosis or detection of disease. For example, to Diagnostics
diagnose diseases, and preferably sub-classify it regarding, for example, severity and treatability or to confirm that a person is free from disease Companion Diagnostics have also been developed to preselect patients for specific treatments based on their own biology. Such targeted therapy holds great promise in the treatment of diseases such as cancer. (also see Genetic Test) Dispensing Fee means a charge levied by pharmacists and added to the price of a drug, which compensates them for their time and pharmaceutical expertise relating to prescription fulfillment including; the selection of the right drug, in the right strength, in the right quantity, with the right labeling for use, and patient consultation (not to include disease therapy management services) Electronic Health Record (EHR) is a digital version of a patients health record, containing medical data, to be shared within a healthcare network. The EHR is created within a healthcare institution providing patient information to the patient, physicians, and payers. The patient controls access to the EHR through a series of permissions. Electronic Medical Record (EMR) is a legal record of a patients medical data. The patients medical data is input to the EHR. (see Electronic Health Record) Enhanced Compliance Program means a pro-active program designed to ensure continuity of therapy and adherence to dosing regimen. May include patient stratification, mid-fill outreach, late to fill intervention, patient mailings, educational materials, specialized packaging, etc.

28.

Dispensing Fee

29.

Electronic Health Record (EHR)

30.

Electronic Medical Record (EMR) Enhanced Compliance Program

31.

32.

Exclusive / semi-exclusive / Participating Provider (contract status)

Exclusive / semi-exclusive / Participating Provider contracts are created when a specialty pharmacy contracts with payors exclusively (1 provider only), semi-exclusively (preferentially based on the payors criteria or more than one), or as a Participating Provider (any willing provider that meets general criteria). Exclusive Distribution means that a drug is available through one sole specialty pharmacy usually coupled with a set of specific support services. Experimental Drug means a substance that has been tested in a laboratory and has obtained approval from the FDA to be tested in humans. A drug may be approved for use in one disease or condition but be considered experimental or investigational in other diseases or conditions. Explanation of Benefits (commonly referred to as an EOB form) is a statement sent by a health insurance company to covered individuals explaining what medical treatments, drugs, and/or services were paid for on their behalf. An EOB typically describes: the service performed the date of the service the description and/or insurer's code for the service the name of the person or place that provided the service the name of the patient the applicable fee for the service, drug, etc. and what the insurer allows (the allowable or the amount initially claimed by the doctor, hospital, or pharmacy minus any reductions applied by the insurer the amount for which the patient is responsible There normally also will be at least a brief explanation of any claims that were denied, along with a point to start an appeal.

33.

Exclusive Distribution

34.

Experimental Drug

35.

Explanation of Benefits

36.

Fair Market Value

Fair Market Value means the estimate of the market value of property, or an asset, that a knowledgeable, willing and unpressured buyer would be willing to pay to a knowledgeable, willing and unpressured seller in the market place. FMV is most commonly used by the pharmaceutical industry to assess the value of Bona Fide Service Fees (i.e. when contracting with a third party to offer services to a patient). Per the regulations, Bona Fide Service Fees are: fees paid by a manufacturer to an entity; that represent fair market value for a bona fide, itemized service actually

performed on behalf of the manufacturer that the manufacturer would otherwise perform (or contract for) in the absence of the service arrangement; and that are not passed on in whole or in part to a client or customer of an entity, whether or not the entity takes title to the drug. 37.

Fee for Service

Fee For Service (FFS) Traditional provider reimbursement, whereby the physician or pharmacy is paid for the service performed. Formulary means a list of prescription drugs covered under a particular prescription drug plan. Patients will pay varying copays and premiums for drugs based on the drugs formulary placement and the particulars of the insureds health plan. Formulary placement is tiered and the patients co-pay is commensurate with the formulary tier - the lower the formulary tier, the lower the co-pay. Tier 1 formulary includes generic products and has the lowest co-pay. Tier 2 describes the preferred products category, tier 3 houses non-formulary products and tier 4 encompasses specialty products. For products on tiers 3 and 4, the co-pays are high and the patient may pay a large percentage, up to 100%, for those products. Most formularies include one drug in each drug class. The responsibility of choosing which drugs to include on a given health plans formulary belongs to the P & T Committee (Pharmacy & Therapeutics Committee). The P&T Committee is an independent medical advisory group within each health plan that reviews new and existing drugs and selects medications to be included in a health plans formulary based on the drugs safety and efficacy profile. The committee selects the most cost-effective drugs for use in each therapeutic class. The committee is comprised of pharmacists and physicians of various specialties. General Distribution means that a product is accessible to any retail or specialty pharmacy. Associated with low compliance, no uniformity of services and typically high inventory levels

38.

Formulary

39.

General Distribution

40.

Generic Drug

Generic Drug means an FDA approved and prescribed drug designated as generic or having an A/B rating according to the Orange Book, or another mutually agreed upon nationally recognized source. A generic drug (generic drugs, short: generics) is a drug defined as a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use. It has also been defined as a term referring to any drug marketed under its chemical name without advertising. A generic drug must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand-name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use. A generic drug of biological type (e.g. monoclonal antibodies), is different to chemical drugs because of its biological nature and it is regulated under an extended set of rules as defined in federal legislation (see Biosimilars).

41.

Genetic Test

Genetic Test (also called DNA-based tests) means a sophisticated technique used to test for genetic disorders involving the direct examination of a persons DNA molecule itself. In specialty pharmacy, genetic tests can confirm the efficacy of a particular medication or eliminate the use of a medication if the results indicate that the required conditions of use are not met. Genetic tests are used for several reasons, including: identifying unaffected individuals who carry one copy of a gene for a disease that requires two copies for the disease to be expressed, for example Huntington's disorder. preimplantation genetic diagnosis prenatal diagnostic testing newborn screening Genealogical DNA test (for genetic genealogy purposes) presymptomatic testing for predicting adult-onset disorders such as Huntington's disease presymptomatic testing for estimating the risk of developing adult-onset cancers and Alzheimer's disease confirmational diagnosis of a symptomatic individual

forensic/identity testing.

The Genetic Information Nondiscrimination Act (GINA) of 2008 and subsequent regulations established detailed privacy requirements that create a firewall between the test information and any payor to prevent potential discrimination based on genetic markers that indicate a potential beneficiary has a disease or might foretell costly diseases. Since genetic testing may open up ethical or psychological problems, genetic testing is often accompanied by genetic counseling (also see Diagnostic Testing) Gross to Net is a term that refers to the percentage of net product sales to gross product sales. Gross product sales are recorded by manufacturers at the time of a sale of product. Net sales is recorded and reported by a manufacturer in their financial statements and is a financial performance indicator focused on by investors, shareholders and financial analysts. There are several categories that could be recorded by a manufacturer as a reduction of gross product sales with the end result being net product sales. Examples of these categories include, but are not limited to: prompt payment discounts, product returns, chargebacks, Medicaid rebates, Medicare Part D rebates, Managed Care rebates, etc. The accounting principles adopted by the manufacturer govern the categories and the methodology to quantify the value of each category of such reductions to gross product sales. The GTN ratio is used by manufacturers to assess their profitability. Guideline in pharmacy means a document that details appropriate drug use criteria based on diagnosis, management, and treatment. Home Health Care (also referred to as domiciliary care or social care), is health care or supportive care provided in the patient's home by healthcare professionals. Often, the term home care is used to distinguish non-medical care or custodial care, which is care that is provided by persons who are not nurses, doctors, or other licensed medical personnel, as opposed to home health care that is provided by licensed personnel. In specialty pharmacy, home health care generally refers to drug administration in the home usually through intravenous infusion requiring nursing services that possess the expertise required to manage more complex administration requirements as well as potential side-effects and adverse

42.

Gross to Net

43.

Guideline

44.

Home Health Care

drug reactions (ADS). Additionally, home health care includes, but is not limited to, educational support to patients and caregivers (e.g., injection training), compliance management, storage and handling of medications, admixing of drugs for self-administration, and nutritional and supportive consultation. Licensed personnel and other persons who assist the individual may be referred to as caregivers. Caregivers may help the individual with such daily tasks as bathing, eating, cleaning the home and preparing meals. For terminally ill patients, home care may include hospice care. For patients recovering from surgery or illness, home care may include rehabilitative assistance (also see Home Infusion) 45.

Home Infusion

46.

Injectable Drug

Home Infusion means the process of infusing a medication via intravenous or other means of administration under the supervision of a professional, licensed clinician. (also see Home Health Care) Injectable Drug means a drug or other aqueous solution injected into the body, usually with a hollow needle and a syringe which is pierced through the skin to a sufficient depth for the material to be forced into the body. An injection follows a parenteral route of administration; that is, administered other than through the digestive tract. There are several methods of injection, including intradermal, subcutaneous, intramuscular, intraocular and intra-articular. Long-acting forms of subcutaneous/intramuscular injections are available for various drugs, and are called depot or bolus injections. Injectables may be administered by a health professional or, when appropriate, by the patient (self-injected) or by a nonhealth professional caregiver.

47.

Infusible Drug

Infusible Drug means a drug or other aqueous solution injected into the body, usually with a hollow needle, through the skin for the material to be forced into the body usually under the direction of a medical professional over a prescribed timeframe and rate of administration. An infusible follows a parenteral route of administration; that is, administered other than through the digestive tract. There are several methods of infusion including intravenous, intraosseous, and intraperitoneal. In specialty pharmacy, infused medications are managed to ensure adherence to strict administration guidelines and minimize the risk of sideeffects and adverse drug reactions (ADR).

48.

Investigational New Drug

Investigational New Drug (IND) means a drug in early stage development whereby a pharmaceutical company obtains permission from the FDA to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The FDA reviews the IND application for safety to assure that research subjects will not be subjected to unreasonable risk. If the application is cleared, the candidate drug usually enters a Phase 1 clinical trial. Key Opinion Leader (KOLs) are scientific, medical, and pharmacology experts who, through their professional reputation, influence the way medicine / pharmacy is practiced and medications are prescribed. Pharmaceutical, biotech, and medical device companies collaborate with, and compensate, KOLs for their involvement in a host of activities including drug discovery and development processes, clinical trial development, advocacy and marketing, to name a few. In 2003, the OIG issued regulations for KOL involvement with drug manufacturers which stated that KOL compensation must be offered in writing and at fair market value. Limited Distribution exists when a manufacturer defines a network (1 or more vendors) as Authorized Distributors of Record or Authorized Pharmacy of Record. Only these entities have the authority to purchase the named drug. Long-Term Care (LTC) Services typically provided for in a

49.

Key Opinion Leader (KOL)

50.

Limited Distribution

51.

Long Term

skilled nursing, intermediate care, personal care, supervisory care, or elder care facility.

52.

Managed Access

53.

Maximum Allowable Cost MAC

Managed Access in specialty pharmacy occurs when a manufacturer sells product to a limited number of licensed specialty distributors or any properly licensed pharmacy, but limits the class of trade a specialty distributor or pharmacy may respectfully sell to or dispense to. Managed Access programs often have sub-networks of authorized purchasers denoted by a manufacturer using its established criteria. Maximum Allowable Cost (MAC) is used by state Medicaid agencies (and other organizations such as PBMs) to determine the payment ceiling for multiple source drugs. These are drugs that are available both from a brand manufacturer, as well as the generic equivalents available from different manufacturers. The MAC is not permitted to be higher in price than the Federal Upper Limit (FUL). The MAC sets a maximum price on drugs within a specific therapeutic class based on the

most cost effective, therapeutically equivalent member of that class. 54.

Medical Management

Medical Management means a program as it relates to the payor or its designee approving and coordinating Covered Services to help ensure quality and efficiency in care delivery, including but not limited to, preauthorization, notification, utilization review, concurrent review and discharge/case management planning through the review of Members clinical information against Medical Necessity Criteria. Medically Necessary means medical or pharmaceutical services that a Member requires in accordance with generally accepted medical practice standards in effect at the time of treatment and in accordance with Medical Necessity Criteria. Medication Therapy Management (MTM) means a distinct service or group of services that optimizes drug therapy with the intent of improved therapeutic outcomes for individual patients. Eleven national pharmacy organizations adopted this definition in 2004. Medication therapy management includes a broad range of professional activities, including but not limited to; performing patient assessment and/or a comprehensive medication review, formulating a medication treatment plan, monitoring efficacy and safety of medication therapy, enhancing medication adherence through patient empowerment and education, and documenting and communicating MTM services to prescribers in order to maintain comprehensive patient care. Medication therapy management includes five core components: a medication therapy review (MTR), personal medication record (PMR), medication-related action plan (MAP), intervention and/or referral, and documentation and follow-up. A MTR is a systematic process of collecting patient and medication-related information which occurs during the pharmacist-patient encounter. In addition, the MTR assists in the identification and prioritization of medication-related problems. During the MTM encounter, the pharmacist develops a PMR for use by the patient. The PMR includes all prescription and nonprescription products and requires

55.

Medically Necessary

56.

Medication Therapy Management

updating as necessary. After assessing and identifying medication-related problems, the pharmacist develops a patient-specific MAP. The MAP is a list of self-management actions necessary to achieve the patients specific health goals. In addition, the patient and pharmacist utilize the MAP to record actions and track progress towards health goals. During the MTM session, the pharmacist identifies medication-related problem(s) and determines appropriate intervention(s) for resolution. Often, the pharmacist collaborates with other health care professionals to resolve the identified problem(s). Following the patient encounter and/or intervention, the pharmacist must document his/her encounter and determine appropriate patient follow-up.

57.

Open Access

Open Access in specialty pharmacy occurs when a manufacturer sells a product to a licensed wholesaler or licensed pharmacy for the eventual use in all appropriate patients, allowing for maximal choice of procurement. Open Door Specialty Pharmacy means a licensed specialty pharmacy that receives prescriptions and patient via a referral model. Open door specialty pharmacies do not offer a retail line of business (e.g., non-specialty products). Patients may pick up their prescriptions and receive pharmacist consultations at the pharmacy or have their prescriptions shipped to a designated location and receive pharmacist consultation remotely. For select products, pharmaceutical manufacturers may or may not specify whether a specialty pharmacy is Open Door or Closed Door as an eligibility criterion for access to a particular drug or program. (see Closed Door Pharmacy) Open network means that a specialty pharmacy vendor has access to a drug from a manufacturer or is eligible for reimbursement by a payor for a drug supplied to a member. A closed network means that the specialty pharmacy does not have access to the drug or the payors network of eligible vendors.

58.

Open Door Specialty Pharmacy

59.

Open Network

60.

Outcome

Outcome means the result of a course of medical and / or pharmacological care that describes the health status of the patient following the course of care. Metrics may be utilized to measure the impact of a course of care and may include survival rates, physiological changes, quality of life (QOL), and more. An outcome may therefore be measured in clinical terms or may be self-reported (i.e., viewed through the eyes of patient) to support informed decisions on the need and course of future care. Outpatient Services means those clinical services that are administered in the ambulatory care setting which includes, but is not limited to, physician offices, clinics, infusion suites, and hospital outpatient clinics.

61.

Outpatient Services

62. `

Pathway

Pathway in pharmacy is a document that details a complex care plan often requiring a progression of drug options based on patient non-response / response to therapy.

63.

Pedigree

Pedigree in pharmacy refers to a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to the transaction(s) thereby establishing a reliable chain-of-custody. As the product moves down the supply chain, each company is required to carry forward all previous pedigree information. In this way, the final point of sale has the complete lineage of every unit. Persistence describes the degree to which a patient refills a prescription according to the course of therapy as written by a prescribing physician (e.g., 30 day supply with 3 refills). Pharmaceutical mean medicinal substances, or Federal Legend Drugs, the original packaging labels of which, under the Federal Food, Drug, and Cosmetic Act, are required to bear the legend: "Caution Federal Law Prohibits Dispensing Without a Prescription", or those substances designated by the State Board of Pharmacy as ones which may only be dispensed pursuant to a prescription. Pharmacist means an individual licensed under state law or governmental unit to engage in the Practice of Pharmacy. (also see Practice of Pharmacy)

64.

Persistence

65.

Pharmaceutical

66.

Pharmacist

67.

Pharmacy And Therapeutics Committee (P&T)

Pharmacy And Therapeutics Committee (P&T) means a panel of physicians, pharmacists, and other health care experts who advise organizations (e.g., a managed care plan, a PBM, CMS, etc.) on the safe and effective use of medications. P&T committees also make recommendations on whether a drug will be included on the organizations formulary as a covered / noncovered benefit and whether other conditions may apply including, but not limited to, prior-authorization and steptherapy criterion, off-label utilization, companion diagnostic / genetic testing, etc. Practice of Pharmacy means the provision of drug dispensing and related services by a licensed Pharmacist according to professional standards, laws, and regulations. Professional functions associated with the Practice of Pharmacy include, but are not limited to, the following: the interpretation and evaluation of a prescription; drug product selection; the procurement, safe storage and dispensing or distribution of drugs and devices; the maintenance of legally required records; advising the prescriber and the patient, as required, as to contents, therapeutic action, utilization and possible adverse reactions and interactions of drugs; For each new prescription, for each Member(or care giver of such Member) who presents a prescription, the Pharmacist must offer to discuss matters, which in the exercise of the Pharmacist's professional judgment and consistent with State law the Pharmacist deems significant, including the following: name of drug; Physician directions for use (dosage), including length and time of therapy; directions and special precautions for preparation, administration and use by the patient; major possible side effects; potential drug interactions; proper storage; refill information; and action to be taken in the case of a missed dose. Preferred Drug List means a subset of the entire formulary, reserved for those products that are being especially promoted by the PBM, based upon proprietary value formulas known only by the PBM.

68.

Practice Of Pharmacy

69.

Preferred Drug List

70.

Prescription Drug Monitoring Program (PDMP) targeted Prescription Drug Monitoring Program (PDMP) management of appropriate use for opioid drugs.

71.

Pricing

Pricing means the manufacturers price for a product depending on class of trade and/or the methodology of calculating the price. Average Wholesale Price (AWP) means the published price of a drug on the date the prescription is dispensed by a Provider based on the Medi-Span Electronic Drug File. Medi-Span is a codified drug dictionary, drug vocabulary, and drug pricing index for prescription drugs and includes Product names , Dose form Route of administration, Strength, Proprietary drug identifiers, including Generic Product Identifier (GPI), Drug Descriptor Identifier (DDID) and the Generic Product Packaging Code (GPPC), Pricing files, Average Wholesale Price (AWP), Wholesale Acquisition Price (WAC). Direct Price (DP), Centers for Medicare & Medicaid Services, Federal Upper Limit (CMS FUL), Average Average Wholesale Price (AAWP), and Generic Equivalent Average Price (GEAP) Wholesale Acquisition Cost (WAC) - represents the manufacturer's (for purposes of this Drug Price Policy, the
term "manufacturer" includes manufacturers, repackagers, private labelers and other suppliers) published catalog or list

price for a drug product to wholesalers as reported by the manufacturer. WAC does not represent actual transaction prices and does not include prompt pay or other discounts, rebates or reductions in price. Average Manufacturer Price (AMP) refers to the average price paid by wholesalers to manufacturers for products distributed to U.S. retail pharmacy class of trade, net certain prompt pay discounts. The AMP calculation is based on actual sales transactions. Manufacturers are required to report AMP data for all Medicaid-covered drugs to CMS on a quarterly basis for the Medicaid Drug Rebate Program. AMP is used to calculate the Federal Upper Limit (FUL) reimbursement of generic drugs by Medicaid. FULs are updated bi-annually. AMP data is not shared with state Medicaid agencies, however. Average Selling Price (ASP) is the manufacturers unit sales of a product to all U.S. purchasers within a calendar quarter divided by the total number of units of the product sold by the manufacturer in that same quarter. The ASP is net of any discounts such as volume, prompt pay, rebates, free-goods, and cash. Average Wholesale Price (AWP) is the price that has been in common use for many years as a basis for calculating reimbursement. For reimbursement of drugs dispensed

at retail pharmacies and specialty pharmacies AWP is calculated by the pricing compendium as follows: manufacturers submit list of WAC prices to the pricing compendium for publication. The pricing compendium takes the submitted list price of the product (WAC), (generally) marks up the WAC price by 20% price and publishes the new value as the AWP. Because manufacturers sales contracts with purchasers are confidential, payers have no other access to real market pricing information. Average Acquisition Cost (AAC) is the cost at which pharmacies within a state purchase a drug, as defined, calculated and reported by the relevant state Medicaid program. Not all states report an AAC. Federal Upper Limit (FUL) as published by HCFA (now CMS) limits the amount Medicaid can reimburse for multi-source drugs, and are established for products if there are three or more versions of the product rated therapeutically equivalent. The Centers for Medicare & Medicaid Services (CMS) maintains and publishes the FUL prices. Direct Price represents the manufacturer's published catalog or list price for a drug product to non-wholesalers. Direct Price does not represent actual transaction prices and does not include prompt pay or other discounts, rebates or reductions.

72.

Prior Authorization

Prior Authorization means the process of obtaining any necessary approval under a specific payors Medical Management program before an approval for payment is issued. Protocol in pharmacy means a treatment plan, care plan, or drug therapy regimen as prescribed by a physician. Protocols are typically a subset of compendia, nationally recognized reference sources, FDA labeling, and society guidelines. For example, in Oncology, protocols are a subset of compendium, NCCN, FDA Label, and ASCO guidelines. Quality Improvement Program means a systematic approach to continuously monitoring, evaluating, and improving the quality and safety of the care and Covered Pharmacy Services provided to Members. This program includes, but is not limited to, licensing, practitioner performance measurement and improvement, clinical practice guidelines, health and lifestyle management and disease management programs.

73.

Protocol

74.

Quality Improvement Program

75.

Risk Evaluation and Mitigation Strategy (REMS)

Risk Evaluation and Mitigation Strategy (REMS) means a program enacted in law under The Food and Drug Administration Amendments Act of 2007 which gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. Manufacturers are required to comply with specific FDA requirements that may include medication use guides, Black box warnings / patient package insert language, a communication plan to health care providers, and potentially the implementation of Elements to Ensure Safe Use (ETASU) and associated reporting. The ETASU is a monitoring system, at both the prescribing and dispensing points, to ensure safe product usage. It includes the following elements: that prescribers are trained or certified, the drug dispensers are certified, the drug is only dispensed to patients in controlled settings, the drug is dispensed with appropriate safe-use documentation, and that patients be monitored and enroll in a patient registry.

76.

Rebate / Rebate Contract

REBATE means any price concession, refund, discount, etc. that may be predicated on purchases and/or dispenses. REBATE CONTRACT is For specialty pharmacies, a contract between the specialty pharmacy and/or the group purchasing organization (GPO) and a pharmaceutical manufacturer to compensate the specialty pharmacy and/or GPO if the specialty pharmacy and/or GPO attain performance criteria that may include, but are not limited to, meeting / exceeding utilization or market share targets, adherence / persistence targets, compliance targets, clinical outcome targets, satisfaction targets, etc. In the context of managed care, a contract between a PBM and pharmaceutical manufacturer to compensate the PBM by the manufacturer if the PBM can guarantee certain levels of use of particular drug products. Restricted Access occurs when a manufacturer sells product to one licensed specialty distributor a limited number of SP directly for sale to specific classes-of-trade and dispensing to patients respectively, under a program services agreement usual requiring REMS or RiskMAP criteria Restricted Distribution means that a drug is accessible only through qualified pharmacies; ensures that patients receive specific services. (See Restricted Access)

77.

Restricted Access

78.

Restricted Distribution

79.

Side-effect / Side-effect Management

Side-effect means a peripheral or secondary effect, especially an undesirable secondary effect of a drug or therapeutic regimen. Side-effect Management means a clinical response or intervention with a patient to a potential or perceived sideeffect. Such response could include patient education (e.g., how to treat an injection site reaction) or instruction to the patient to seek immediate medical attention (e.g., severe reaction to a drug). Site of Care is a facility where a patient receives treatment or testing such as a doctors office, clinic, hospital, laboratory, ambulatory infusion center, radiology center, etc. A pharmacy can also be a site of care if administration of a drug is provided on premises. Specialty Dispensing is the professional practice of prescription fulfillment based on a valid prescription written by a licensed physician or other licensed health practitioner authorized in their jurisdiction. Specialty dispensing practices include expert therapy management services, coupled with patient education and counseling, that collectively drive adherence, compliance & persistence, manage dosing, and monitor appropriate medication use and safety. Specialty Distribution is the model wherein a specialty distributor takes physical possession and title to the product(s) sold directly to specialty pharmacies, physician offices, specialty groups, clinics, occupational health facilities, government health departments, and other licensed practitioners. Specialty distributors commonly stock innovative products that do not meet the full-line wholesale structure and/or stock a complete line of products including vaccines and biologicals, brand name & generic injectables, and pharmaceuticals. Additionally, specialty distributors often sell diagnostic test kits and reagents; medical & surgical supplies to the alternate care market. Specialty distributors must be licensed by each state in which they transact business. Specialty Pharmaceutical means a typically high cost injectable/infused/oral and other form of therapy that may require special handling, refrigeration, and/or adherence to treatment protocols. (also see SPAARx Board Approved Definition of Specialty Pharmacy ) See SPAARx Board Approved Definition of Specialty Pharmacy

80.

Site of Care (SOC)

81.

Specialty Dispensing

82.

Specialty Distribution (SD)

83.

Specialty Pharmaceutical

84.

Specialty Pharmacy

85.

Standard of Care

Standard of Care is the degree of prudence and caution required of a pharmacist who is under a duty of care for an established patient. A pharmacists duty of care is explicitly defined under Medication Therapy Management and Practice of Pharmacy. Step Therapy is an approach to prescription intended to control the costs and risks posed by prescription drugs. The practice begins medication for a medical condition with the most cost-effective and safest drug therapy and progresses to other more costly or risky therapies only if necessary. Also called step protocol or a fail first requirement. Summary Plan Description is a document that details the medical and pharmacy benefit schedule for a particular individual through an insurance company or other payor. Utilization Management means the evaluation of the appropriateness, medical need and efficiency of health care services, procedures, drugs, and facilities according to established criteria or guidelines and under the provisions of an applicable health benefits plan. Typically it includes new activities or decisions based upon the analysis of a case. Utilization management describes proactive procedures, including discharge planning, concurrent planning, precertification, clinical case appeals, and drug regimen protocols or pathways. It also covers proactive processes, such as concurrent clinical reviews and peer reviews, as well as appeals introduced by the provider, payer or patient. Utilization management is the precursor to Utilization Review and are not synonymous (although the terms are often used interchangeably). Utilization Management is prospective and intends to manage health care cases efficiently and cost effectively before and during health care administration. Utilization Review is more retrospective considering whether health care was appropriately applied after it was administered.

86.

Step Therapy

87.

Summary Plan Description

88.

Utilization Management / Utilization Review

89.

Wholesale Acquisition Cost WAC

Wholesale Acquisition Cost (WAC) - Manufacturers develop wholesale acquisition prices for wholesalers and distributors and submit their WAC prices for commercial publication in the Pharmaceutical Pricing Compendium (pricing compendium), which details product pricing and reimbursement. WAC does not represent actual sales prices and does not include any discounts, rebates or price reductions. (also see Pricing)

90.

White Bagging

White Bagging is the term that describes a shipment of a medication to a physician or other licensed practitioner for patient administration in response to a patient-specific prescription.