Code of Massachusetts Regulations › 130 CMR - DIVISION OF MEDICAL ASSISTANCE › Title 130 CMR 406.000 - Pharmacy Services › Section 406.402 - Definitions

Current through Register 1525, July 5, 2024
The following terms used in
				130 CMR
				406.000 have the meanings given in
				130
				CMR 406.402, unless the context clearly
				requires a different meaning. The reimbursability of services defined in
				130 CMR
				406.000 is not determined by these definitions, but by
				application of regulations elsewhere in
				130 CMR
				406.000, and in
				130 CMR
				450.000:
Administrative and Billing
				Regulations
.
340B-covered Entities
. Facilities and
				programs eligible to purchase discounted drugs through a program established by
				Public Health Law 102-585, § 340B of the Veterans Health Act of
				1992.
340B Drug Pricing Program
. A program
				established by Public Health Law 102-585, § 340B of the Veterans Health
				Act of 1992.
Compounded Drug
. Any drug, excluding
				cough preparations, in which two or more active ingredients, at least one of
				which is a drug, are extemporaneously mixed by a registered pharmacist.
Controlled Substance
. A drug listed in
				Schedule II, III, IV, V or VI of the Massachusetts Controlled Substances Act
				(M.G.L. c. 94C).
Durable Medical Equipment Specialty
. A
				designation by the MassHealth agency for pharmacy providers whose primary
				business is not providing durable medical equipment, but that nevertheless are
				qualified pursuant to the applicable requirements of
				130 CMR
				409.000:
Durable Medical Equipment
				Services
to provide durable medical equipment not listed on the
				Non-drug Product List to MassHealth Members.
Drug
. A substance as defined by the
				Food, Drug, and Cosmetic Act, containing one or more active ingredients in a
				specified dosage form and strength. Each dosage form and strength is a separate
				drug.
Electronic Prescription
. A
				prescription transmitted electronically in compliance with applicable state and
				federal law.
Gross Cost Per Utilizer Per Year.
Annual cost per utilizer projected by EOHHS based on factors including actual
				or expected utilization, dosing information, duration of therapy, and the
				National Average Drug Acquisition Cost (NADAC) or Wholesale Acquisition Cost
				(WAC) (when NADAC is not available) of the covered drug prior to any federal or
				supplemental rebate.
Health Insurer
. A private or public
				entity, including Medicare, that has a health plan or policy under which it
				pays for medical services provided to a member. An endorsed discount card
				issued in accordance with the Social Security Act § 1860D-31(a) is not
				considered a health insurance plan or policy.
Interchangeable Drug Product
. A
				product containing a drug in the same amounts of the same active ingredients in
				the same dosage form as another product with the same generic or chemical name
				that has been determined to be therapeutically equivalent (that is, "A"-rated)
				by the Food and Drug Administration Center for Drug Evaluation and Research
				(FDA CDER), or by the Massachusetts Drug Formulary Commission.
MassHealth Drug List
. A list of
				commonly prescribed drugs and therapeutic class tables published by MassHealth.
				The MassHealth Drug List specifies the drugs that are payable under MassHealth.
				The list also specifies which drugs require prior authorization. Except for
				drugs and drug therapies described in
				130
				CMR 406.413(B), any drug
				that does not appear on the MassHealth Drug List requires prior authorization,
				as otherwise set forth in
				130 CMR
				406.000.
Multiple-source Drug
. A drug marketed
				or sold by two or more manufacturers or labelers, or a drug marketed or sold by
				the same manufacturer or labeler under two or more different names.
Non-drug Product List
. A section of
				the MassHealth Drug List comprised of those products not classified as drugs
				(
i.e.
, blood testing supplies) that are payable by the
				MassHealth agency through the Pharmacy Program. Except as designated by
				Pharmacy Facts, provider bulletin, or other written issuance from the
				MassHealth agency, payment for these items is in accordance with rates
				published in EOHHS regulations at
				101 CMR
				322.00:
Durable Medical Equipment, Oxygen, and
				Respiratory Therapy Equipment
and
				101 CMR
				317.00
: Rates for Medicine Services
.
				The MassHealth Non-drug Product List also specifies which of the included
				products require prior authorization.
Over-the-counter Drug
. Any drug for
				which no prescription is required by federal or state law. These drugs are
				sometimes referred to as non-legend drugs. The MassHealth agency requires a
				prescription for both prescription drugs and over-the-counter drugs
				(
see
130
				CMR 406.411(A)).
Oxygen and Respiratory Therapy Equipment
				Specialty
. Designation by the MassHealth agency for pharmacy
				providers whose primary business is not the provision of oxygen and respiratory
				therapy equipment, but that nonetheless are qualified pursuant to the
				applicable requirements of
				130 CMR
				427.000:
Oxygen and Respiratory Therapy
				Equipment
(excepting any requirement that the provider primarily
				engage in the in the business of supplying oxygen and respiratory therapy
				equipment to the public) to provide oxygen and respiratory therapy equipment
				not listed on the Non-drug Product List to MassHealth Members.
Pharmacy Covered Professional Services
				List
. A section of the MassHealth Drug List comprised of those
				professional services that are payable by the MassHealth agency through the
				Pharmacy Program.
Pharmacy Online Processing System
				(POPS)
. The online, real-time computer network that adjudicates
				pharmacy claims, incorporating prospective drug utilization review, prior
				authorization, and member eligibility verification.
Prescription Drug
. Any drug for which
				a prescription is required by applicable federal or state law or regulation,
				other than MassHealth regulations. These drugs are sometimes referred to as
				legend drugs.
Retail Establishment
. A physical place
				of business at which the provider dispenses prescription and over-the-counter
				drugs; a business conducted by mail, telephone, the internet, or any other
				remote means does not constitute a "retail establishment".
Step Therapy Protocol
. A utilization
				management policy or program that establishes the specific sequence in which a
				prescription drug for a specified medical condition is covered by the
				MassHealth agency.