Colorado § 10-16-1401 - Definitions.

§ 10-16-1401. Definitions.

As used in this part 14, unless the context otherwise requires:

(1) "Advisory council" means the Colorado prescription drug affordability advisory council created in section 10-16-1409.

(2) "Affordability review" means an affordability review of a prescription drug performed by the board pursuant to section 10-16-1406.

(3) "All-payer health claims database" means the all-payer health claims database described in section 25.5-1-204.

(4) "Authorized generic drug" has the meaning set forth in 42 CFR 447.502.

(5) "Biological product" has the meaning set forth in 42 U.S.C. sec. 262 (i)(1).

(6) "Biosimilar drug" means a prescription drug that is produced or distributed in accordance with a biological product license issued pursuant to 42 U.S.C. sec. 262 (k)(3).

(7) "Board" means the Colorado prescription drug affordability review board created in section 10-16-1402.

(7.5) "Board activity" means:

(a) Selecting prescription drugs for an affordability review pursuant to section 10-16-1406 (2);

(b) Determining whether a prescription drug is unaffordable pursuant to section 10-16-1406 (3);

(c) Selecting prescription drugs for which the board establishes an upper payment limit pursuant to section 10-16-1407; and

(d) Establishing an upper payment limit for a prescription drug pursuant to section 10-16-1407.

(8) "Brand-name drug" means a prescription drug that is produced or distributed in accordance with an original new drug application approved pursuant to 21 U.S.C. sec. 355. "Brand-name drug" does not include an authorized generic drug.

(9) "Carrier" has the meaning set forth in section 10-16-102 (8).

(10) "Conflict of interest" means an association, including a financial or personal association, that has the potential to bias or appear to bias an individual's decisions in matters related to the board or the advisory council or the conduct of the activities of the board or the advisory council. "Conflict of interest" includes any instance in which a board member; an advisory council member; a staff member; a contractor of the division, on behalf of the board; or an immediate family member of a board member, an advisory council member, a staff member, or a contractor of the division, on behalf of the board, has received or could receive:

(a) A financial benefit of any amount derived from the results or findings of a study or determination that is reached by or for the board; or

(b) A financial benefit from an individual or company that owns or manufactures a prescription drug, service, or item that is being or will be studied by the board.

(11) "Financial benefit" means honoraria, fees, stock, or any other form of compensation, including increases to the value of existing stock holdings.

(12) "Generic drug" means:

(a) A prescription drug that is marketed or distributed in accordance with an abbreviated new drug application approved pursuant to 21 U.S.C. sec. 355 (j);

(b) An authorized generic drug; or

(c) A prescription drug that was introduced for retail sale before 1962 that was not originally marketed under a new drug application.

(13) "Health benefit plan" has the meaning set forth in section 10-16-102 (32).

(14) "Inflation" means the annual percentage change in the United States department of labor's bureau of labor statistics consumer price index for Denver-Aurora-Lakewood for all items paid by all urban consumers, or its applicable predecessor or successor index.

(15) (a) "Large employer" means any person that:

(I) Is actively engaged in business;

(II) Employed an average of more than fifty eligible employees on business days during the immediately preceding calendar year, except as provided in subsection (15)(c) of this section; and

(III) Was not formed primarily for the purpose of purchasing insurance.

(b) For purposes of determining whether an employer is a "large employer", the number of eligible employees is calculated using the method set forth in 26 U.S.C. sec. 4980H (c)(2)(E).

(c) In the case of an employer that was not in existence throughout the preceding calendar quarter, the determination of whether the employer is a large employer is based on the average number of employees that the employer is reasonably expected to employ on business days in the current calendar year.

(16) "Manufacturer" means a person that:

(a) Engages in the manufacture of a prescription drug that is sold to purchasers located in this state; or

(b) (I) Enters into a lease or other contractual agreement with a manufacturer to market and distribute a prescription drug in this state under the person's own name; and

(II) Sets or changes the wholesale acquisition cost of the prescription drug in this state.

(17) "Optional participating plan" means a self-funded health benefit plan offered in Colorado that elects to subject its purchases of or payer reimbursements for prescription drugs for its members in Colorado to the requirements of this part 14, as described in section 10-16-1407 (8).

(18) "Practitioner" has the meaning set forth in section 12-280-103 (40).

(19) "Prescription drug" has the meaning set forth in section 12-280-103 (42); except that the term includes only prescription drugs that are intended for human use.

(20) "Pricing information" means information about the price of a prescription drug, including information that explains or helps explain how the price was determined.

(21) "Small employer" has the meaning set forth in section 10-16-102 (61).

(22) "State entity" means any agency of state government that purchases or reimburses payers for prescription drugs on behalf of the state for a person whose heath care is paid for by the state, including any agent, vendor, contractor, or other party acting on behalf of the state.

(23) "Upper payment limit" means the maximum amount that may be paid or billed for a prescription drug that is dispensed or distributed in Colorado in any financial transaction concerning the purchase of or reimbursement for the prescription drug.

(24) "Wholesale acquisition cost" has the meaning set forth in 42 U.S.C. sec. 1395w-3a (c)(6)(B).

(25) "Wholesaler" has the meaning set forth in section 12-280-103 (55).

Source: L. 2021: Entire part added, (SB 21-175), ch. 240, p. 1257, § 2, effective June 16. L. 2023: (7.5) added, (HB 23-1225), ch. 162, p. 704, § 1, effective August 7. L. 2024: IP(15)(a) and (15)(a)(II) amended, (SB 24-073), ch. 146, p. 592, § 4, effective January 1, 2026.

Editor's note: Subsection (15) is repealed when the conditions under § 10-16-105.1 (3.5)(e)(II) have occured.