Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 101 - MAINECARE BENEFITS MANUAL (FORMERLY MAINE MEDICAL ASSISTANCE MANUAL) › Chapter II - Specific Policies By Service › Section 144-101-II-80 - Pharmacy Services › Subsection 144-101-II-80.01 - DEFINITIONS

Current through 2024-29, July 17, 2024
80.01-1
Authorized
					 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.
80.01-2
Acute 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.
80.01-3
Brand-Name Drug
is
					 defined as a single-source drug, a cross-licensed drug, or an innovator
					 drug.
80.01-4
Buprenorphine
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
.
80.01-5
Caloric 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.
80.01-6
Chronic 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.
80.01-7
Compound 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).
80.01-8
Controlled
					 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.
80.01-9
Covered Drugs
are drugs that are reimbursable pursuant to Section
					 80.05.
80.01-10
Creditable 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.
80.01-11
DESI
means the Drug Efficacy Study Implementation Program of the
					 Food and Drug Administration (FDA).
80.01-12
Dispensing 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.
80.01-13
Drug Utilization Review (DUR)
means a process designed to ensure
					 that prescriptions are appropriate, medically necessary and not likely to
					 result in adverse medical results.
80.01-14
Drug 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.
80.01-15
Food
					 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.
80.01-16
Formulary
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.
80.01-17
Generic drugs
are drugs
					 other than those defined as brand-name drugs.
80.01-18
Legend 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.
80.01-19
Lock-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.
80.01-20
Mail 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.
80.01-21
Maine 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.
80.01-22
Maine 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).
80.01-23
Maintenance 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.
80.01-24
Maximum 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.
80.01-25
Medical
					 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.
80.01-26
Medicare Part D
means
					 the prescription drug benefit provided under the
Medicare Prescription
					 Drug Improvement and Modernization Act of 2003
,
					 Public Law
					 108-173.
80.01-27
Medicare 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.
80.01-28
Medi-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.
80.01-29
Metropolitan 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.
80.01-30
National 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.
80.01-31
New Drugs
are drugs that receive a New Drug Application (NDA) from
					 the Food and Drug Administration after November 1, 1990.
80.01-32
Non-Preferred Drugs
are
					 covered drugs that are not preferred drugs.
80.01-33
OBRA 90
is the
Omnibus Budget Reconciliation Act of 1990
as
					 amended.
80.01-34
Opioid
					 Medication
is a controlled substance containing an opioid and included
					 in 21
United States Code
, Section 812 or
					 21
Code of Federal
					 Regulations
, Part 1308.
80.01-35
Over-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.
80.01-36
Over-The-Counter Drug
					 (OTC)
is a drug that can be purchased without a prescription.
80.01-37
Pharmacy 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
.
80.01-38
Preferred 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.
80.01-39
Preferred 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.
80.01-40
Prescription 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.
80.01-41
Retail
					 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.
80.01-42
Specialty 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.
80.01-43
Specialty 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.
80.01-44
Specialty 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.
80.01-45
State Drug File
is the
					 drug file database used by the Department for the purpose of managing the
					 pharmacy benefit.
80.01-46
Telepharmacy
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.
80.01-47
Therapeutic Category
is
					 a grouping of drugs by comparable therapeutic effect, as determined by the
					 Department.
80.01-48
Usual
					 & Customary Charge
is the reimbursement amount the general public is
					 requested to pay for the goods or services provided.