3 Colo. Code Regs. § 702-9-1.1
The statutory authority for this rule includes but is not limited to section 10-16-1403(5), C.R.S.
The purpose of this rule is to provide necessary definitions of terms used throughout the rules.
"Advisory Council" has the same meaning set forth in section 10-16-1401(1), C.R.S.
"Affordability Review" means a review of a as prescription drug performed by the Board pursuant to section 10-16-1406(3) -(7), C.R.S., to determine whether use of the prescription drug consistent with the labeling approved for prescription drug by the FDA or with standard medical practice is unaffordable for Colorado consumers.
"All-Payer Health Claims Database" or "APCD" has the same meaning as set forth in section 10-16-1401(3), C.R.S.
"Authorized Generic Drug" has the same meaning as set forth in section 10-16-1401(4), C.R.S.
"Average Sales Price" has the same meaning as set forth in section 42 U.S.C. § 1395w-3a(c).
"Biological Product" has the same meaning as set forth in section 10-16-1401(5), C.R.S.
"Biosimilar Drug" has the same meaning as set forth in section 10-16-1401(6), C.R.S.
"Board Activity" has the same meaning as set forth in section 10-16-1401 (7.5), C.R.S.
"Board" has the same meaning as set forth in section 10-16-1401(7), C.R.S.
"Board Staff" means any individual employed by the Division of Insurance providing support to and/or doing work on behalf of the Board.
"Brand-name Drug" has the same meaning as set forth in section 10-16-1401(8), C.R.S.
"Carrier" has the same meaning as set forth in section 10-16-102(8), C.R.S.
"Days" means calendar days.
"Division" or "Division of Insurance" means the Colorado Division of Insurance or any successor entity.
"FDA" has the same meaning as set forth in section 10-16-102 (27.5), C.R.S.
"Generic Drug" has the same meaning as set forth in section 10-16-1401(12), C.R.S.
"HCPF" means the Colorado Department of Health Care, Policy & Financing or any successor entity.
"Health Benefit Plan" has the same meaning as set forth in section 10-16-102(32), C.R.S.
"Inflation" has the same meaning as set forth in section 10-16-1401(14), C.R.S.
"Initial WAC" means the earliest listed WAC for a prescription drug.
"Manufacturer" has the same meaning as set forth in section 10-16-1401(16), C.R.S.
"Medicare Maximum Fair Price" has the same meaning as determined by section 42 U.S.C. § 1320f(c)(3).
"National Drug Code" or "NDC" means the numeric code associated with a finished drug product or unfinished drug that identifies its labeler, product, and package size and type.
"Off-label usage" means the use of a prescription drug for a disease or medical condition that is outside the FDA-approved indication(s).
"Optional Participating Plan" has the same meaning as set forth in section 10-16-1401(17), C.R.S.
"Out-of-Pocket Costs" means the amount a covered person is required to pay in the form of cost-sharing for covered benefits in a plan year, including deductibles, coinsurance, and copayments.
"Person" includes an individual, limited liability company, partnership, corporation, association, county, and public or private organization of any character other than an agency.
"Pharmacist" has the same meaning as set forth in section 12-280-103(35), C.R.S.
"Pharmacy Benefit Management Firm" or "PBM" has the same meaning as set forth in section 10-16-102(49), C.R.S.
"Plan ID" means the unique health benefit plan identifier, including number and/or name, and, as applicable, the plan identification number used for Centers for Medicare and Medicaid Services' Health Insurance and Oversight System
"Plan Year" means a consecutive 12 month period during which a health plan provides coverage for health benefits. A plan year may be a calendar year or otherwise.
"Prescription Drug" has the same meaning as set forth in section 10-16-1401(19), C.R.S.
"Pricing Information" has the same meaning as set forth in section 10-16-1401(20), C.R.S
"Priority Populations" means people experiencing homelessness; people involved with the criminal justice system; black people, indigenous people, and people of color; American Indians and Alaska natives; veterans; people who are lesbian, gay, bisexual, transgender, queer, or questioning; people of disproportionately affected sexual orientations, gender identities, or sex assigned at birth; people who have AIDS or HIV; older adults; children and families; and people with disabilities, including people who are deaf and hard of hearing, people who are blind and deafblind, people with brain injuries, people with intellectual and developmental disabilities, people with other co-occurring disabilities; and other populations as deemed appropriate by the Prescription Drug Affordability Board.
"Provider" has the same meaning as set forth in section 10-16-102(56), C.R.S.
"State Entity" has the same meaning as set forth in section 10-16-1401(22), C.R.S.
"Therapeutic Alternative" means a drug product that contains a different therapeutic agent than the drug in question, but is the same pharmacological or therapeutic class and has been shown through peer-reviewed studies to have similar therapeutic effects, safety profile, and expected outcome when administered to patients in a therapeutically equivalent dose or has been recommended as consistent with standard medical practice by medical professional association guidelines.
"Therapeutically Equivalent" means approved drug products that are pharmaceutical equivalents for which bioequivalence has been demonstrated, and that can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.
"Upper Payment Limit" has the same meaning as set forth in section 10-16-1401(23), C.R.S.
"Wholesale Acquisition Cost" ("WAC") has the same meaning as set forth in section 10-16-1401(24), C.R.S.
"Wholesaler" has the same meaning as set forth in section 12-280-103(55), C.R.S.
3 CCR 702-9-1.1