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) [ Editor's note: This version of the introductory portion to subsection
(15)(a) is effective until January 1, 2026. ] Large employer means any person, firm,
corporation, partnership, or association that:
(15) (a) [ Editor's note: This version of the introductory portion to subsection
(15)(a) is effective January 1, 2026. ] Large employer means any person that:
(I) Is actively engaged in business;
(II) [ Editor's note: This version of subsection (15)(a)(II) is effective until
January 1, 2026. ] Employed an average of more than one hundred eligible
employees on business days during the immediately preceding calendar year,
except as provided in subsection (15)(c) of this section; and
(II) [ Editor's note: This version of subsection (15)(a)(II) is effective January 1,
2026. ] 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).