2023 Colorado Revised Statutes › Title 10 - INSURANCE (§§ 10-1-101 — 10-23-110) › HEALTH CARE COVERAGE (§§ 10-16-101 — 10-16.5-101) › Article 16 - HEALTH-CARE COVERAGE (§§ 10-16-101 — 10-16-1506) › Part 14 - COLORADO PRESCRIPTION DRUG AFFORDABILITY REVIEW BOARD (§§ 10-16-1401 — 10-16-1416) › Section 10-16-1407 - Colorado prescription drug affordability review board - upper payment limits for certain prescription drugs - rules - severability

(1)
(a)
The board may establish an upper payment limit for any prescription drug for which the board has performed an affordability review pursuant to section
10-16-1406
and determined that the use of the prescription drug is unaffordable for Colorado consumers; except that:
(I)
The board may not establish an upper payment limit for more than twelve prescription drugs in each calendar year for three years beginning April 1, 2022, unless the board determines that there is a need to establish upper payment limits for more than twelve prescription drugs, in which case the board may establish an upper payment limit for up to eighteen prescription drugs so long as the board has sufficient staff support to do so; and
(II)
For each prescription drug for which the board establishes an upper payment limit, the board may include multiple national drug codes, as described in
21 CFR 207.33
, that are indicated for the prescription drug.
(b)
The failure of an entity to provide information to the board pursuant to section
10-16-1406 (7)(b)
does not affect the authority of the board to establish an upper payment limit for a prescription drug.
(2)
The board shall determine by rule the methodology for establishing an upper payment limit for a prescription drug to protect consumers from the excessive cost of prescription drugs and ensure they can access prescription drugs necessary for their health. The methodology must include consideration of:
(a)
The cost of administering or dispensing the prescription drug;
(b)
The cost of distributing the prescription drug to consumers in the state;
(c)
The status of the prescription drug on the drug shortage list published by the drug shortage program within the FDA; and
(d)
Other relevant costs related to the prescription drug.
(3)
The methodology determined by the board pursuant to subsection (2) of this section must consider the impact to older adults and persons with disabilities and shall not place a lower value on their lives.
(4)
The methodology determined by the board pursuant to subsection (2) of this section:
(a)
Shall not consider research or methods that employ a dollars-per-quality adjusted life year, or similar measure, that discounts the value of a life because of an individual's disability or age; and
(b)
Must authorize a pharmacy licensed by the state board of pharmacy to charge reasonable fees, to be paid by the providing health benefit plan of the consumer, for dispensing or delivering a prescription drug for which the board has established an upper payment limit.
(5)
An upper payment limit applies to all purchases of and payer reimbursements for a prescription drug that is dispensed or administered to individuals in the state in person, by mail, or by other means and for which an upper payment limit is established. The board shall promulgate rules that establish upper payment limits and the effective date of any upper payment limit established by the board, which effective date is at least six months after the adoption of the upper payment limit by the board and applies only to purchases, contracts, and plans that are issued on or renewed after the effective date.
(6)
The board shall promulgate rules to notify consumers of any decision to establish an upper payment limit pursuant to this section.
(7)
Any information submitted to the board in accordance with this section or section
10-16-1405
or
10-16-1406
is subject to public inspection only to the extent allowed under the "Colorado Open Records Act", part 2 of article
72
of title
24
, and in no case shall trade-secret, confidential, or proprietary information be disclosed to any person who is not authorized to access such information pursuant to section
10-16-1406
.
(8)
Notwithstanding any provision of this part 14 to the contrary, with respect to an entity providing or administering a self-funded health benefit plan and its plan members, the requirements of this part 14 apply only if the plan elects to be subject to this part 14 for its members in Colorado. Such a plan is an optional participating plan for the purposes of this part 14.
(9)
If any provision of this section or its application to any person or circumstance is held invalid, the invalidity does not affect other provisions or applications of this section that can be given effect without the invalid provision or application, and to this end the provisions of this section are severable.
(10)
For any upper payment limit established by the board pursuant to this section, the board shall:
(a)
Inquire of manufacturers of the prescription drug as to whether each such manufacturer is able to make the prescription drug available for sale in the state and request the rationale for the manufacturer's response; and
(b)
Submit annually to the health and human services committee of the senate and the health and insurance committee of the house of representatives, or to any successor committees, the response of each manufacturer to the inquiry described in subsection (10)(a) of this section.
Amended by 2023 Ch. 162,§ 5, eff. 8/7/2023.
Added by 2021 Ch. 240, § 2, eff. 6/16/2021.
2023 Ch. 162, was passed without a safety clause. See Colo. Const. art. V, § 1(3).