Definitions

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 Section 340B of Public Health Law 102-585, the Veterans Health Care Act of 1992. 340B Drug Pricing Program. A program established by Section 340B of Public Health Law 102-585, the Veterans Health Care 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. 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 Section 1860D-31(a) of the Social Security Act 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 (e.g., 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: Rates for 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 nonlegend 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 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.