C.M.R. 10, 144, ch. 101, ch. II, 144-101-II-80, subsec. 144-101-II-80.01

Current through 2024-51, December 18, 2024

Subsection 144-101-II-80.01 - DEFINITIONS

80.01-1Authorized Representative refers to the Department's authority per 22 M.R.S.A. §§3174-II and LD 1325 to enroll and reenroll MaineCare members into a Medicare Part D plan, apply for Medicare Part D benefits and subsidies on their behalf, and at the Department's discretion, file exceptions and appeals on their behalf. The Department may also identify a designee for this function.

80.01-2Acute pain is pain, whether related to disease, injury, or recent surgery, that is the normal, predicted physiological response and is time-limited, usually diminishing with soft tissue healing.

80.01-3Brand-Name Drug is defined as a single-source drug, a cross-licensed drug, or an innovator drug.

80.01-4Buprenorphine is used in Medication-Assisted Treatment (MAT) to help people reduce or quit their use of heroin or other opiates, such as pain relievers like morphine. Buprenorphine and all products containing buprenorphine are controlled in Schedule III of the Controlled Substances Act.

80.01-5Caloric Supplements/Substitutes are over-the-counter products that contain fats, and/or proteins, and/or carbohydrates and are prescribed by a licensed provider for the express purpose of enhancing caloric intake to address an illness or condition.

80.01-6Chronic Pain is Pain that persists beyond the usual course of an acute disease or healing of an injury that causes continuous or intermittent pain over months or years and involves neurological, emotional, and behavioral features that often impact a patient's quality of life and function.

80.01-7Compound Prescription is any product for which two (2) or more ingredients are extemporaneously mixed in usually accepted therapeutic doses. This requires the pharmacist's skill in weighing, measuring, levigating, etc., at the time of dispensing. The allowable compounding fee applies to the preparation of an individual prescription. It does not apply to prescriptions dispensed from a previously prepared stock supply (i.e., premixing a special lotion or ointment in gallons or pounds).

80.01-8Controlled Substances are drugs that come within the scope of the Controlled Substances Act and are divided into five schedules- I, II, III, IV and V.

80.01-9Covered Drugs are drugs that are reimbursable pursuant to Section 80.05.

80.01-10Creditable Coverage is when the actual value of coverage equals or exceeds the actuarial value of standard Medicare prescription drug coverage, as demonstrated through the use of generally accepted actuarial principles and in accordance with CMS actuarial guidelines.

80.01-11DESI means the Drug Efficacy Study Implementation Program of the Food and Drug Administration (FDA).

80.01-12Dispensing Practitioner is a licensed practitioner who, within the scope of his or her license, prepares and dispenses medication, instructs patients to self-administer medication on a regular basis, and is located no less than fifteen (15) miles from a licensed pharmacy.

80.01-13Drug Utilization Review (DUR) means a process designed to ensure that prescriptions are appropriate, medically necessary and not likely to result in adverse medical results.

80.01-14Drug Utilization Review Committee (DUR Committee) means an advisory committee to the Department of Health and Human Services for the MaineCare program and other State prescription benefits administered by the Office of MaineCare Services (OMS), comprised of physicians and pharmacists who are licensed to prescribe or dispense drugs in Maine. The DUR Committee conducts drug utilization review for the Department.

80.01-15Food and Drug Administration (FDA) Orange Book, referred to as the "Orange Book" in this Section, is the FDA Approved Drug Products with Therapeutic Equivalence Evaluations, which rates the therapeutic equivalence of generic drugs.

80.01-16Formulary is a list of medicines that includes all Legend (prescription) Drugs, to comply with OBRA 90 as amended, except those excluded by these regulations and those over-the-counter drugs listed in Section 80.05-1.

80.01-17Generic drugs are drugs other than those defined as brand-name drugs.

80.01-18Legend Drug is a drug bearing the statement "CAUTION: Federal Law Prohibits Dispensing Without a Prescription" or "Rx Only," as allowed by the Food and Drug Administration.

80.01-19Lock-in, for the purpose of this Section, is when members are restricted to obtaining all or specific prescriptions from only one provider and/or pharmacy.

80.01-20Mail Order Pharmacy Provider is a pharmacy provider that dispenses prescription medications by U.S. mail or private carrier. Mail order pharmacy providers must have a NABP (National Association of Boards of Pharmacy) provider number uniquely identifying the provider as a mail order pharmacy for purposes of billing. Mail order pharmacy providers must be licensed by the Maine Board of Pharmacy, enrolled as Medicare and MaineCare providers, and be operating under contract with the Department. Mail order pharmacy providers must dispense prescription medications from within the United States. Mail order pharmacy providers must process claims through the State's electronic claims processing system to the standards required by the Department.

80.01-21Maine Drugs for the Elderly Benefit (DEL) provides low-cost prescription and limited over-the-counter drugs and medical supplies to certain elderly and disabled members pursuant to 22 M.R.S.A. §254-D. The DEL Benefit, which is not a MaineCare benefit, is further described in Chapter 104, Section 2.

80.01-22Maine Maximum Allowable Cost (MMAC) is the maximum cost allowed by the Maine Department of Health and Human Services for some multiple source drugs and other non-drug covered products provided through the pharmacy point of service system (POS).

80.01-23Maintenance Drugs are drugs that are used to treat conditions that are usually chronic or long-term. Maintenance drugs include caloric supplements/substitutes, medical foods, and specialty drugs.

80.01-24Maximum Allowable Cost (MAC) is the Federal Upper Limit (FUL) established by the federal government for certain prescription drugs. The MaineCare program reimbursement to a pharmacy may not exceed the MAC for any such drugs.

80.01-25Medical Food is a product prescribed by a licensed provider for a member with special nutrient needs, in order to manage a disease or health condition, when the member is under the provider's on-going care. The label must clearly state that the product is intended to manage a specific medical disorder or condition. An example of a medical food is a food for use by persons with phenylketonuria, i.e., foods formulated to be free of the amino acid phenylalanine. Medical foods are limited to formula only.

80.01-26Medicare Part D means the prescription drug benefit provided under the Medicare Prescription Drug Improvement and Modernization Act of 2003, Public Law 108-173.

80.01-27Medicare Part D Excluded Drugs are those drugs not covered by Medicare Part D pursuant to Title XIX, Section 1927, which the Department will continue to reimburse if otherwise covered under this Section.

80.01-28Medi-Span is a nationally recognized published drug database. The Department uses the designations in this database to create its State drug file to determine which drugs are brand-name (single-source, cross-licensed or innovator) and which drugs are generic (multiple-source) drugs for the purposes of calculating reimbursement.

80.01-29Metropolitan Statistical Area (MSA) is a federal standardized designation using postal zip codes to define rural areas. The Department will define rural by applying MSA/Non-MSA designation to the zip code of the member's residence.

80.01-30National Drug Code (NDC) is a universal drug coding system for human drugs established by the Federal Food and Drug Administration (FDA). The FDA assigns each drug a unique identifier specifying the labeler/vendor, product, and package.

80.01-31New Drugs are drugs that receive a New Drug Application (NDA) from the Food and Drug Administration after November 1, 1990.

80.01-32Non-Preferred Drugs are covered drugs that are not preferred drugs.

80.01-33OBRA 90 is the Omnibus Budget Reconciliation Act of 1990 as amended.

80.01-34Opioid Medication is a controlled substance containing an opioid and included in 21 United States Code, Section 812 or 21Code of Federal Regulations, Part 1308.

80.01-35Over-ride is a situation where unusual circumstances warrant the Department to authorize a pharmacy to waive a standard condition or requirement for dispensing a medication in order to process a claim.

80.01-36Over-The-Counter Drug (OTC) is a drug that can be purchased without a prescription.

80.01-37Pharmacy Provider is, for the purposes of determining the proper reimbursement charge, a corporation, association, partnership, or individual that either provides pharmacy services pursuant to a provider agreement or is related by ownership or control to an entity that provides MaineCare pharmacy services, and also accepts Medicare assignment. This definition of provider applies only to Section 80, "Pharmacy Services", in the MaineCare Benefits Manual.

80.01-38Preferred Drugs are covered drugs that have a lower net cost and/or advantages in clinical efficacy within a therapeutic category as determined by the Department after reviewing the recommendation of the Drug Utilization Review Committee.

80.01-39Preferred Drug List (PDL) is a listing of covered drugs setting forth such information as their status as preferred or non-preferred, whether prior authorization is required, step order, and any other information as determined by the Department to be helpful to members, pharmacists, prescribers and other interested parties.

80.01-40Prescription Monitoring Program (PMP) the Controlled Substances Prescription Monitoring Program, established under 22 M.R.S.A. §7248, is a database of transactions for controlled substances dispensed in the State of Maine.

80.01-41Retail Pharmacy Provider is a pharmacy that possesses a valid outpatient pharmacy license issued by the Board of Pharmacy, accepts Medicare assignment, and which serves MaineCare members. Out-of-state domestic retail pharmacy providers within fifteen (15) miles of the Maine/New Hampshire border are treated the same as Maine retail pharmacy providers, as provided in MaineCare Benefits Manual, Chapter I, Section 1.03.

80.01-42Specialty Drugs are covered drugs that, due to their high cost, short shelf life, special handling requirements and instruction, or other factors, are obtained from Specialty Pharmacy Providers. Specialty drugs are prescribed for a limited number of usually chronic conditions that generally affect a relatively small portion of the population.

80.01-43Specialty Drug List is a list established by the Department of covered drugs consisting of certain specialty drugs that the Department has determined may be obtained through Department-approved Specialty Pharmacy Providers. The Department will post and update the Specialty Drug List on the designated website.

80.01-44Specialty Pharmacy Providers are those pharmacies approved by the Department to dispense specialty drugs. Specialty pharmacy providers must have a separate MaineCare provider number uniquely identifying the provider as a specialty pharmacy for purposes of billing. Specialty pharmacy providers must be approved by the Department, unless the pharmacy provider already has an approved written agreement with the Department as of April 1, 2005 to dispense growth hormones or synagis only.

80.01-45State Drug File is the drug file database used by the Department for the purpose of managing the pharmacy benefit.

80.01-46Telepharmacy is a method of delivering prescriptions dispensed by a pharmacist to a remote site. Pharmacies using telepharmacy delivery of prescriptions must follow all applicable State and Federal regulations and Maine State Board of Pharmacy rules, including using staff qualified to deliver prescriptions through telepharmacy.

80.01-47Therapeutic Category is a grouping of drugs by comparable therapeutic effect, as determined by the Department.

80.01-48Usual & Customary Charge is the reimbursement amount the general public is requested to pay for the goods or services provided.

C.M.R. 10, 144, ch. 101, ch. II, 144-101-II-80, subsec. 144-101-II-80.01