Colo. Rev. Stat. § 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) [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).

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.

10-16-1402. Colorado prescription drug affordability review board - created - membership - terms - conflicts of interest. (1) The Colorado prescription drug affordability review board is created in the division. The board is a type 1 entity, as defined in section 24-1-105. The board exercises its powers and performs its duties and functions under the department of regulatory agencies and is allocated to the division of insurance. The board is a body politic and corporate and is an instrumentality of the state. The board is an independent unit of state government, and the exercise by the board of its authority under this part 14 is an essential public function.

(2) (a) The board consists of five members, who must each have an advanced degree and experience or expertise in health-care economics or clinical medicine.

(b) The governor shall appoint each board member, subject to confirmation by the senate. All of the initial members of the board must be appointed by October 1, 2021.

(c) The term of office of each board member is three years; except that, as to the terms of the members who are first appointed to the board, two such members shall serve three-year initial terms, two such members shall serve two-year initial terms, and one such member shall serve a one-year initial term, to be determined by the governor. The governor may remove any appointed member of the board for malfeasance in office, for failure to regularly attend meetings, or for any cause that renders the member incapable or unfit to discharge the duties of the member's office, and any such removal is not subject to review.

(d) The governor shall designate one member of the board to serve as the chair. A majority of the board constitutes a quorum. The concurrence of a majority of the board in any matter within its powers and duties is required for any determination made by the board.

(3) (a) An individual who is being considered for appointment to the board shall disclose any conflict of interest to the individual's potential appointing authority. When appointing a member of the board, an appointing authority shall consider any conflict of interest disclosed by the prospective member.

(b) A board member must not be an employee, board member, or consultant of:

(I) A manufacturer or a trade association of manufacturers;

(II) A carrier or a trade association of carriers; or

(III) A pharmacy benefit manager or a trade association of pharmacy benefit managers.

(c) (I) Board members shall recuse themselves from any board activity or vote in any case in which they have a conflict of interest.

(II) Staff members and contractors of the division, on behalf of the board, shall disclose any conflict of interest related to a prescription drug for which the board is conducting an affordability review or establishing an upper payment limit.

(III) Notwithstanding subsection (3)(d) of this section and the reporting requirements set forth in section 10-16-1414 (1)(f), a conflict of interest disclosed by a staff member or by a contractor of the division, which disclosure pertains to a personal association, must remain confidential. The board, upon review of such a disclosure, may direct the staff member or contractor to recuse themselves based on the conflict of interest.

(d) On and after January 1, 2022, the division shall maintain a page on its public website for the board to use for its purposes. The board shall disclose on the page each conflict of interest that is disclosed to the board pursuant to subsection (3)(c) of this section and section 10-16-1409 (5)(b).

(e) Board members, staff members, contractors of the division, on behalf of the board, and immediate family members of board members, staff members, or contractors shall not accept a financial benefit or gifts, bequests, or donations of services or property that suggest a conflict of interest or have the appearance of creating bias in the work of the board.

(4) The attorney general shall assign an assistant attorney general to provide legal counsel to the board. Any assistant attorney general assigned to the board pursuant to this subsection (4) shall disclose any conflict of interest to the board.

Source: L. 2021: Entire part added, (SB 21-175), ch. 240, p. 1260, � 2, effective June 16. L. 2022: (1) amended, (SB 22-162), ch. 469, p. 3390, � 102, effective August 10. L. 2023: (3)(c) amended, (HB 23-1225), ch. 162, p. 705, � 2, effective August 7.

Cross references: For the short title (the Debbie Haskins 'Administrative Organization Act of 1968' Modernization Act) in SB 22-162, see section 1 of chapter 469, Session Laws of Colorado 2022.

10-16-1403. Colorado prescription drug affordability review board - powers and duties - rules. (1) To protect Colorado consumers from excessive prescription drug costs, the board shall:

(a) Collect and evaluate information concerning the cost of prescription drugs sold to Colorado consumers, as described in section 10-16-1405;

(b) Perform affordability reviews of prescription drugs, as described in section 10-16-1406;

(d) Make policy recommendations to the general assembly to improve the affordability of prescription drugs for Colorado consumers, as described in section 10-16-1414 (1)(h).

(2) The board may establish ad hoc work groups to consider matters related to the work of the board pursuant to this part 14. Ad hoc work groups may include members of the public.

(3) The division, on behalf of the board, may enter into a contract with a qualified, independent third party for any service necessary to carry out the powers and duties of the board. A third party with which the division contracts pursuant to this subsection (3), including any of the third party's directors, officers, employees, contractors, or agents, shall not release or publish any information that the third party acquires pursuant to its performance under the contract. Any third party with which the division contracts pursuant to this subsection (3) shall disclose any conflict of interest to the board.

(4) In carrying out its duties pursuant to this part 14, the division, when performing its duties on behalf of the board, is exempt from the state Procurement Code, articles 101 to 112 of title 24.

(5) The board shall promulgate rules as necessary, pursuant to article 4 of title 24, for the implementation of this part 14.

(6) (a) The division, on behalf of the board, may seek, accept, and expend gifts, grants, and donations from private or public sources for the purposes of this part 14, and any such gifts, grants, and donations are continuously appropriated to the department of regulatory agencies; except that the division shall not accept any gift, grant, or donation that creates a conflict of interest or the appearance of any conflict of interest for any board member.

(b) The general assembly finds that the implementation of this part 14 does not rely entirely on the receipt of adequate funding through gifts, grants, or donations. Therefore, the board is not subject to the reporting requirements described in section 24-75-1303.

Source: L. 2021: Entire part added, (SB 21-175), ch. 240, p. 1261, � 2, effective June 16.

10-16-1404. Colorado prescription drug affordability review board meetings - required to be public - exceptions. (1) The board shall hold its first meeting within six weeks after all of the board members are appointed and shall meet at least every six weeks thereafter to review prescription drugs; except that the chair may cancel or postpone a meeting if the board has no prescription drugs to review or for good cause.

(2) The board is a state public body for purposes of section 24-6-402, and the board's meetings and the meetings of ad hoc work groups of the board are public meetings.

(3) The board shall meet in executive session to discuss proprietary information. The board and any board members, officers, directors, employees, contractors, and agents shall not disclose or otherwise make available to the public any materials or information containing trade-secret, confidential, or proprietary data that is not otherwise available to the public. Electronic recordings of such executive sessions are not permitted if they would result in the disclosure of any materials or information containing trade-secret, confidential, or proprietary data, and in no case shall minutes from such executive sessions disclose or include materials or information containing trade-secret, confidential, or proprietary data. The board shall not take any of the following actions while meeting in executive session:

(a) Deliberations concerning whether to subject a prescription drug to an affordability review as described in section 10-16-1406;

(b) Votes concerning whether to establish an upper payment limit on a prescription drug; or

Source: L. 2021: Entire part added, (SB 21-175), ch. 240, p. 1262, � 2, effective June 16. L. 2023: (1) amended, (HB 23-1225), ch. 162, p. 705, � 3, effective August 7.

10-16-1405. Colorado prescription drug affordability review board - reports from carriers and pharmacy benefit management firms required - confidential materials. (1) Beginning in the 2022 calendar year, for all prescription drugs dispensed at a pharmacy in this state and paid for by a carrier pursuant to a health benefit plan issued under part 2, 3, or 4 of this article 16 during the immediately preceding calendar year, including brand-name drugs, authorized generic drugs, biological products, and biosimilar drugs:

(a) Each carrier and each pharmacy benefit management firm acting on behalf of a carrier shall report to the all-payer health claims database the following information:

(I) The top fifteen prescription drugs by volume, calculated by unit, for which the carrier paid;

(II) The fifteen costliest prescription drugs for which the carrier paid, as determined by total annual plan spending;

(III) The fifteen prescription drugs paid for by the carrier that accounted for the highest increase in total annual plan spending when compared with the total annual plan spending for the same prescription drugs in the year immediately preceding the year for which the information is reported;

(IV) The fifteen prescription drugs that caused the greatest increases in the carrier's premiums;

(V) The fifteen prescription drugs for which the carrier paid most frequently and for which the carrier received a rebate from manufacturers;

(VI) The fifteen prescription drugs for which the carrier received the highest rebates, as determined by percentages of the price of the prescription drug;

(VII) The fifteen prescription drugs for which the carrier received the largest rebates;

(VIII) The total spending for each of the following categories of prescription drugs:

(A) Brand-name drugs purchased from retail pharmacies;

(B) Authorized generic drugs purchased from retail pharmacies;

(D) Authorized generic drugs purchased from mail-order pharmacies;

(E) Prescription drugs dispensed by a practitioner in accordance with section 12-280-120 (6);

(F) Prescription drugs administered in an inpatient hospital setting; and

(G) Prescription drugs administered in an outpatient hospital setting; and

(IX) The total spending for the prescription drugs described in subsection (1)(a)(VIII) of this section paid for by a carrier pursuant to a health benefit plan issued under part 2, 3, or 4 of this article 16 during the immediately preceding calendar year for each of the following market sectors:

(A) Individual;

(B) Small employer; and

(b) If the all-payer health claims database does not collect and maintain the data that is required to be reported to the database pursuant to subsection (1)(a) of this section, the administrator of the all-payer health claims database shall amend the requirements regarding the data to be submitted to the database pursuant to section 25.5-1-204 (5) to include the data required by subsection (1)(a) of this section during the next update of such requirements, but no later than June 1, 2022.

(2) The administrator of the all-payer health claims database shall provide to the commissioner, in a form and manner determined by the commissioner, the information that is reported to the database by carriers and pharmacy benefit management firms pursuant to subsection (1)(a) of this section.

(3) (a) Except as provided in subsection (3)(b) of this section, the commissioner shall:

(I) Post the information reported by carriers and pharmacy benefit management firms pursuant to this section on the division's website; and

(II) Provide the information reported by carriers and pharmacy benefit management firms pursuant to this section to the board, in a form and manner prescribed by the board.

(b) If a carrier or pharmacy benefit management firm claims that information submitted pursuant to this section is confidential or proprietary, the commissioner shall review the information and redact specific items that the carrier or pharmacy benefit management firm demonstrates to be confidential or proprietary. The commissioner shall not disclose redacted items to any person; except that the commissioner may disclose redacted items:

(I) As may be required pursuant to the Colorado Open Records Act, part 2 of article 72 of title 24; and

(II) To employees of the division, as necessary.

(4) The requirement in this section to report information relating to the cost of prescription drugs is intended to create transparency in prescription drug pricing and does not:

(a) Prohibit a manufacturer of a prescription drug from making pricing decisions about its prescription drugs; or

(b) Prohibit purchasers, both public and private, or pharmacy benefit management firms from negotiating discounts and rebates consistent with existing state and federal law.

Source: L. 2021: Entire part added, (SB 21-175), ch. 240, p. 1263, � 2, effective June 16.

10-16-1406. Colorado prescription drug affordability review board - affordability reviews of prescription drugs. (1) The board may conduct affordability reviews of prescription drugs in accordance with this section. The board shall identify, for purposes of determining whether to conduct an affordability review:

(a) Any prescription drug that has:

(I) A wholesale acquisition cost of three thousand dollars or more;

(I.5) An increase of three hundred dollars or more above the wholesale acquisition cost for the prescription drug in the preceding twelve months;

(II) An increase of two hundred percent or more above the wholesale acquisition cost for the prescription drug in the preceding twelve months; or

(III) A current wholesale acquisition cost for an average course of treatment per person per year of thirty thousand dollars or more; and

(b) Any biosimilar drug that has an initial wholesale acquisition cost that is not at least fifteen percent lower than the wholesale acquisition cost of the corresponding biological product.

(1.1) Repealed.

(2) After identifying prescription drugs as described in subsection (1) of this section, the board shall determine whether to conduct an affordability review for an identified prescription drug by:

(a) Evaluating the class of the prescription drug and whether any therapeutically equivalent prescription drugs are available for sale;

(b) Evaluating aggregated data;

(d) Considering the average patient's out-of-pocket cost for the prescription drug; and

(e) Considering whether the drug has an approved orphan drug designation for one or more rare diseases and no other indications and, if so, considering input from consumers and the Colorado rare disease advisory council created in section 25-1-1503.

(3) If the board conducts an affordability review of a prescription drug, the affordability review must determine whether use of the prescription drug consistent with the labeling approved for the prescription drug by the FDA or with standard medical practice is unaffordable for Colorado consumers.

(4) In performing an affordability review, to the extent practicable, the board shall consider:

(a) The wholesale acquisition cost of the prescription drug;

(b) The cost and availability of therapeutic alternatives to the prescription drug in the state;

(d) The relative financial effects on health, medical, or social services costs, as the effects can be quantified and compared to baseline effects of existing therapeutic alternatives to the prescription drug;

(e) The patient copayment or other cost sharing that is associated with the prescription drug and typically required pursuant to health benefit plans issued by carriers in the state;

(f) The impact on safety net providers if the prescription drug is available through section 340B of the federal Public Health Service Act, Pub.L. 78-410;

(g) Orphan drug status;

(h) Input from:

(I) Patients and caregivers affected by the condition or disease that is treated by the prescription drug that is under review by the board;

(II) Individuals who possess scientific or medical training with respect to a condition or disease treated by the prescription drug that is under review by the board; and

(III) The Colorado rare disease advisory council created in section 25-1-1503;

(i) Any other information that a manufacturer, carrier, pharmacy benefit management firm, or other entity chooses to provide; and

(j) Any other factors as determined by rules promulgated by the board pursuant to section 10-16-1403 (5).

(5) Trade-secret, confidential, or proprietary information obtained by the board pursuant to this section may be accessed only by board members and staff or by a qualified independent third party that has contracted with the division pursuant to section 10-16-1403 (3) and is subject to a nondisclosure agreement prohibiting disclosure of such information. Any person with access to such information shall protect the information from direct or indirect publication or release to any person.

(6) In performing an affordability review of a prescription drug, the board may consider any documents and information relating to the manufacturer's selection of the introductory price or price increase of the prescription drug, including documents and information relating to:

(a) Life-cycle management;

(b) The average cost of the prescription drug in the state;

(d) Projected revenue;

(e) The estimated cost-effectiveness of the prescription drug; and

(f) Off-label usage of the prescription drug.

(7) (a) To the extent practicable, the board may access pricing information for prescription drugs by:

(I) Accessing publicly available pricing information from a state to which manufacturers report pricing information;

(II) Accessing available pricing information from the all-payer health claims database and from state entities; and

(III) Accessing information that is available from other countries.

(b) To the extent that there is no publicly available information with which to conduct an affordability review, the board may request that a manufacturer, carrier, or pharmacy benefit management firm provide pricing information for any prescription drug identified pursuant to subsection (1) of this section. The failure of an entity to provide pricing information to the board for an affordability review does not affect the authority of the board to conduct the affordability review, as described in this section.

(8) The board shall issue a report summarizing, to the extent permitted by section 10-16-1404 (3), the data that the board considered in making the board's determination as to whether a prescription drug is unaffordable. The board shall make the report available on its public web page.

Source: L. 2021: Entire part added, (SB 21-175), ch. 240, p. 1265, � 2, effective June 16. L. 2023: IP(1), (1)(a), (1)(b), and IP(2) amended and (8) added, (HB 23-1225), ch. 162, p. 705, � 4, effective January 1, 2025; (1.1) added by revision, (HB 23-1225), ch. 162, pp. 705, 709, �� 4, 11. L. 2024: (2)(c), (2)(d), and (4)(h) amended and (2)(e) added, (SB 24-203), ch. 454, p. 3150, � 1, effective August 7.

Editor's note: (1) Section 97 of HB 23-1301 amended the effective date of HB 23-1225 from January 1, 2026, to January 1, 2025. (See L. 2023, p. 1848.)

(2) Subsection (1.1) provided for the repeal of subsections (1)(c) and (1.1), effective January 1, 2025. (See L. 2023, pp. 705, 709.)

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.

Source: L. 2021: Entire part added, (SB 21-175), ch. 240, p. 1268, � 2, effective June 16. L. 2023: (1) and (5) amended, (HB 23-1225), ch. 162, p. 706, � 5, effective August 7.

10-16-1408. Colorado prescription drug affordability review board - judicial review. (1) The following board functions are not final agency actions subject to judicial review under the State Administrative Procedure Act, article 4 of title 24:

(a) Identification of eligible prescription drugs pursuant to section 10-16-1406 (1);

(b) Selection of a prescription drug pursuant to section 10-16-1406 (2); and

(2) A rule of the board establishing an upper payment limit is a final agency action subject to judicial review under the State Administrative Procedure Act, article 4 of title 24. A party seeking judicial review of a rule establishing an upper payment limit may seek review of whether the prescription drug satisfies the necessary criteria in section 10-16-1406 to be eligible for an upper payment limit.

(3) Repealed.

(4) Notwithstanding any provision of law to the contrary:

(a) An individual may request an expedited review, as described in section 10-16-113.5, of access to a prescription drug that is unavailable to the individual because a manufacturer refuses to make the drug available as a result of an upper payment limit established for the prescription drug by the board; and

(b) A carrier may disregard the upper payment limit if the independent external review entity that performs the expedited review determines pursuant to such review that the prescription drug should be covered for and available to that individual.

Source: L. 2021: Entire part added, (SB 21-175), ch. 240, p. 1270, � 2, effective June 16. L. 2023: (1) and (2) amended and (3) repealed, (HB 23-1225), ch. 162, p. 707, � 6, effective August 7.

10-16-1409. Colorado prescription drug affordability advisory council - created - membership - powers and duties. (1) (a) The Colorado prescription drug affordability advisory council is created in the division to provide stakeholder input to the board regarding the affordability of prescription drugs. The advisory council is a type 2 entity, as defined in section 24-1-105. The advisory council exercises its powers and performs its duties and functions under the department of regulatory agencies and is allocated to the division of insurance. The advisory council includes fifteen members as follows:

(I) The executive director of the department of health care policy and financing or the executive director's designee; and

(II) Fourteen members appointed by the board as follows:

(A) Two members who are health-care consumers or who represent health-care consumers;

(B) One member representing a statewide health-care consumer advocacy organization;

(D) One member representing a labor union;

(E) One member representing employers;

(F) One member representing carriers;

(G) One member representing pharmacy benefit management firms;

(H) One member representing health-care professionals with prescribing authority;

(I) One member who is employed by an organization that performs research concerning prescription drugs, including research concerning pricing information;

(J) One member representing manufacturers of brand-name drugs;

(K) One member representing manufacturers of generic drugs;

(L) One member representing pharmacists; and

(M) One member representing wholesalers.

(b) To the extent possible, the board shall appoint council members who have experience serving underserved communities and reflect the diversity of the state with regard to race, ethnicity, immigration status, income, wealth, disability, age, gender identity, and geography. In considering geographic diversity, the board shall ensure at least one council member resides on the eastern plains and one member resides on the western slope, and the board shall attempt to appoint members from each congressional district in the state.

(2) Each member of the advisory council must possess knowledge of at least one of the following subject matters:

(a) The pharmaceutical business model;

(b) Supply chain business models;

(d) Health-care consumer or patient perspectives;

(e) Health-care cost trends and drivers;

(f) Clinical and health services research; or

(g) The state's health-care marketplace.

(3) The term of each member of the advisory council is three years; except that the members initially appointed to the advisory council pursuant to subsections (1)(a)(II)(A) to (1)(a)(II)(E) of this section shall each serve initial terms of two years.

(4) The chair of the board shall designate one member of the advisory council to serve as chair of the advisory council.

(5) (a) An individual who is being considered for appointment to the advisory council shall disclose any conflict of interest to the board in a form and manner prescribed by the board. When appointing a member of the advisory council, the board shall consider any conflict of interest disclosed by the prospective member.

(b) The chair of the advisory council shall report to the board any conflict of interest that is disclosed to the advisory council. The board shall include information concerning such disclosures on its public website pursuant to section 10-16-1402 (3)(d).

(6) The advisory council shall meet at least once every three months; except that the chair may cancel or postpone a meeting.

(7) (a) Except as described in subsection (7)(b) of this section, the advisory council shall conduct all of its meetings in public.

(b) Notwithstanding section 24-6-402, the advisory council may meet privately in groups of three or fewer members for the following purposes, so long as no formal action is taken at the meeting:

(I) To gather and understand data; or

(II) To establish, organize, and plan for the business of the advisory council.

Source: L. 2021: Entire part added, (SB 21-175), ch. 240, p. 1271, � 2, effective June 16. L. 2022: IP(1)(a) amended, (SB 22-162), ch. 469, p. 3390, � 103, effective August 10.

Cross references: For the short title (the Debbie Haskins 'Administrative Organization Act of 1968' Modernization Act) in SB 22-162, see section 1 of chapter 469, Session Laws of Colorado 2022.