First Regular Session
Seventy-fourth General Assembly
STATE OF COLORADO
REREVISED
This Version Includes All Amendments
Adopted in the Second House
LLS NO. 23-0867.01 Richard Sweetman x4333
HOUSE BILL 23-1225
House Committees Senate Committees
Health & Insurance Health & Human Services
A BILL FOR AN ACT
C
ONCERNING THE PRESCRIPTIO N DRUG AFFORDABILITY BOARD , AND,101
IN CONNECTION THEREWITH , MODIFYING THE AFFORDABILITY102
REVIEW PROCESS, ALLOWING THE BOARD TO ESTABLISH UPPER103
PAYMENT LIMITS FOR AN ADDITIONAL
NUMBER OF104
PRESCRIPTION DRUGS, CLARIFYING WHICH BOARD FUNCTIONS105
ARE SUBJECT TO JUDICIAL REVIEW , AUTHORIZING AN106
INDIVIDUAL TO REQUEST AN I NDEPENDENT EXTERNAL REVIEW107
OF A DENIAL OF A REQUEST FOR BENEFITS FOR A PRESCRIPTION108
DRUG THAT HAS BEEN WITHDRAWN FROM SALE OR109
DISTRIBUTION IN THE STATE, AND EXTENDING THE REPEAL DATE110
OF THE BOARD.111
Bill Summary
SENATE
3rd Reading Unamended
April 24, 2023
SENATE
Amended 2nd Reading
April 21, 2023
HOUSE
3rd Reading Unamended
March 21, 2023
HOUSE
Amended 2nd Reading
March 20, 2023
HOUSE SPONSORSHIP
deGruy Kennedy and Dickson, Amabile, Bacon, Bird, Brown, Duran, English, Epps,
Froelich, Garcia, Gonzales-Gutierrez, Hamrick, Herod, Jodeh, Joseph, Kipp, Lieder, Lindsay,
Lindstedt, Lukens, Mabrey, Mauro, McCluskie, McCormick, McLachlan, Michaelson Jenet,
Ortiz, Ricks, Sharbini, Sirota, Snyder, Story, Titone, Velasco, Vigil, Weissman, Woodrow,
Young
SENATE SPONSORSHIP
Jaquez Lewis and Buckner, Coleman, Cutter, Priola
Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment.
Capital letters or bold & italic numbers indicate new material to be added to existing law.
Dashes through the words or numbers indicate deletions from existing law. (Note: This summary applies to this bill as introduced and does
not reflect any amendments that may be subsequently adopted. If this bill
passes third reading in the house of introduction, a bill summary that
applies to the reengrossed version of this bill will be available at
http://leg.colorado.gov
.)
In 2021, the general assembly enacted SB 21-175, which created
the prescription drug affordability board (board) in the division of
insurance (division) and an affordability review process whereby the
board may review costs associated with, and establish upper payment
limits for, certain prescription drugs. The bill makes certain changes
concerning the board.
Section 1 defines "board activity", and section 2 states that only
board members, and not staff members or contractors of the division, are
required to recuse themselves from any board activity or vote where they
have a conflict of interest.
Section 3 allows the chair of the board to cancel or postpone a
board meeting for good cause.
Section 4 makes certain changes to the procedure by which the
board identifies prescription drugs that may be subjected to an
affordability review. Section 4 also requires the board to report on its
public web page certain information regarding its considerations.
Section 5 removes language prohibiting the board from
establishing an upper payment limit for more than 12 prescription drugs
within a specified period.
Section 6 establishes that an upper payment limit for a prescription
drug is not a final agency action that is subject to judicial review until the
board promulgates a rule establishing the upper payment limit.
Sections 6 and 7 remove certain language describing an appeals
process for appealing decisions of the board.
Sections 8 and 9 extend the repeal and associated sunset review
of the board from September 1, 2026, to September 1, 2031.
Section 10 establishes that a denial of a request for benefits for a
prescription drug that is unavailable in the state because a manufacturer
has withdrawn the prescription drug from sale or distribution within the
state is an "adverse determination" for which an individual may request
an independent external review.
Be it enacted by the General Assembly of the State of Colorado:1
SECTION 1. In Colorado Revised Statutes, 10-16-1401, add2
(7.5) as follows:3
10-16-1401. Definitions. As used in this part 14, unless the4
1225-2- context otherwise requires:1
(7.5) "B
OARD ACTIVITY" MEANS:2
(a) S
ELECTING PRESCRIPTION DRUGS FOR AN AFFORDABILITY3
REVIEW PURSUANT TO SECTION 10-16-1406 (2);4
(b) D
ETERMINING WHETHER A PRESCRIPTION DRUG IS5
UNAFFORDABLE PURSUANT TO SECTION 10-16-1406 (3);6
(c) S
ELECTING PRESCRIPTION DRUGS FOR WHICH THE BOARD7
ESTABLISHES AN UPPER PAYMENT LIMIT PURSUANT TO SECTION8
10-16-1407;
AND9
(d) E
STABLISHING AN UPPER PAYMENT LIMIT FOR A PRESCRIPTION10
DRUG PURSUANT TO SECTION 10-16-1407.11
SECTION 2. In Colorado Revised Statutes, 10-16-1402, amend12
(3)(c) as follows:13
10-16-1402. Colorado prescription drug affordability review14
board - created - membership - terms - conflicts of interest.15
(3) (c) (I)
Board members staff members, and contractors of the division,16
on behalf of the board, shall recuse themselves from any board activity OR17
VOTE in any case in which they have a conflict of interest.18
(II) S
TAFF MEMBERS AND CONTRACTORS OF THE DIVISION , ON
19
BEHALF OF THE BOARD, SHALL DISCLOSE ANY CONFLICT OF INTEREST20
RELATED TO A PRESCRIPTION DRUG FOR WHICH THE BOARD IS CONDUCTING21
AN AFFORDABILITY REVIEW OR ESTABLISHING AN UPPER PAYMENT LIMIT .22
(III) N
OTWITHSTANDING SUBSECTION (3)(d) OF THIS SECTION AND
23
THE REPORTING REQUIREMENTS SET FORTH IN SECTION 10-16-1414 (1)(f),24
A CONFLICT OF INTEREST DISCLOSED BY A STAFF MEMBER OR BY A25
CONTRACTOR OF THE DIVISION , WHICH DISCLOSURE PERTAINS TO A26
PERSONAL ASSOCIATION, MUST REMAIN CONFIDENTIAL. THE BOARD, UPON27
1225
-3- REVIEW OF SUCH A DISCLOSURE , MAY DIRECT THE STAFF MEMBER OR1
CONTRACTOR TO RECUSE THEMSELF BASED ON THE CONFLICT OF INTEREST .2
SECTION 3. In Colorado Revised Statutes, 10-16-1404, amend3
(1) as follows:4
10-16-1404. Colorado prescription drug affordability review5
board meetings - required to be public - exceptions. (1) The board6
shall hold its first meeting within six weeks after all of the board7
members are appointed and shall meet at least every six weeks thereafter8
to review prescription drugs; except that the chair may cancel or postpone9
a meeting if the board has no prescription drugs to review
OR FOR GOOD10
CAUSE.11
SECTION 4. In Colorado Revised Statutes, 10-16-1406, amend12
(1)(a), (1)(b), and (2) introductory portion; repeal (1)(c); and add (8) as13
follows:14
10-16-1406. Colorado prescription drug affordability review15
board - affordability reviews of prescription drugs. (1) The board may16
conduct affordability reviews of prescription drugs in accordance with17
this section. The board shall identify, for purposes of determining whether18
to conduct an affordability review: any prescription drug that is:19
(a) A brand-name drug or biological product that, as adjusted20
annually for inflation, has ANY PRESCRIPTION DRUG THAT HAS:21
(I) An initial A wholesale acquisition cost of thirty THREE22
thousand dollars or more; for a twelve-month supply or for a course of23
treatment that is less than twelve months in duration; or24
(I.5) A
N INCREASE OF THREE HUNDRED DOLLARS OR MORE ABOVE25
THE WHOLESALE ACQUISITION COST FOR THE PRESCRIPTION DRUG IN THE26
PRECEDING TWELVE MONTHS ;27
1225
-4- (II) An increase in the wholesale acquisition cost of ten percent1
or more during AN INCREASE OF TWO HUNDRED PERCENT OR MORE ABOVE2
THE WHOLESALE ACQUISITION COST FOR THE PRESCRIPTION DRUG IN the3
immediately preceding twelve months; for a twelve-month supply or for4
a course of treatment that is less than twelve months in duration; OR5
(III) A
CURRENT WHOLESALE ACQUISITION COST FOR AN AVERAGE6
COURSE OF TREATMENT PER PERSON PER YEAR OF THIRTY THOUSAND7
DOLLARS OR
MORE; AND8
(b) A ANY biosimilar drug that has an initial wholesale acquisition9
cost that is not at least fifteen percent lower than
THE WHOLESALE10
ACQUISITION COST OF the corresponding biological
product. or11
(c) A generic drug: 12
(I) That, as adjusted annually for inflation, has a wholesale13
acquisition cost of one hundred dollars or more for:14
(A) A thirty-day supply based on the recommended dosage15
approved for labeling by the FDA;16
(B) A supply that lasts less than thirty days based on the17
recommended dosage approved for labeling by the FDA; or18
(C) One dose of the generic drug if the labeling approved by the19
FDA does not recommend a finite dosage; and20
(II) For which the wholesale acquisition cost increased by two21
hundred percent or more during the immediately preceding twelve22
months, as determined by comparing the current wholesale acquisition23
cost to the average wholesale acquisition cost reported during the24
immediately preceding twelve months.25
(2) After identifying prescription drugs as described in subsection26
(1) of this section, the board shall determine whether to conduct an27
1225
-5- affordability review for each AN identified prescription drug by:1
(8) T
HE BOARD SHALL ISSUE A REPORT SUMMARIZING , TO THE2
EXTENT PERMITTED BY SECTION 10-16-1404 (3), THE DATA THAT THE3
BOARD CONSIDERED IN MAKING THE BOARD 'S DETERMINATION AS TO4
WHETHER A PRESCRIPTION DRUG IS UNAFFORDABLE . THE BOARD SHALL5
MAKE THE REPORT AVAILABLE ON ITS PUBLIC WEB PAGE .6
SECTION 5. In Colorado Revised Statutes, 10-16-1407, amend7
(1) and (5) as follows:8
10-16-1407. Colorado prescription drug affordability review9
board - upper payment limits for certain prescription drugs - rules10
- severability. (1) (a) The board may establish an upper payment11
limit for any prescription drug for which the board has performed an12
affordability review pursuant to section 10-16-1406 and determined that13
the use of the prescription drug is unaffordable for Colorado consumers;14
except that:15
(I) The board may not establish an upper payment limit for more16
than twelve prescription drugs in each calendar year for three years17
beginning April 1, 2022,
UNLESS THE BOARD DETERMINES THAT THERE IS
18
A NEED TO ESTABLISH UPPER PAYMENT LIMITS FOR MORE THAN TWELVE19
PRESCRIPTION DRUGS, IN WHICH CASE THE BOARD MAY ESTABLISH AN20
UPPER PAYMENT LIMIT FOR UP TO EIGHTEEN PRESCRIPTION DRUGS SO LONG21
AS THE BOARD HAS SUFFICIENT STAFF SUPPORT TO DO SO ; AND22
(II) F
OR EACH PRESCRIPTION DRUG FOR WHICH THE BOARD
23
ESTABLISHES AN UPPER PAYMENT LIMIT , THE BOARD MAY INCLUDE24
MULTIPLE NATIONAL DRUG CODES , AS DESCRIBED IN 21 CFR 207.33, THAT25
ARE INDICATED FOR THE PRESCRIPTION DRUG .26
(b) The failure of an entity to provide information to the board27
1225
-6- pursuant to section 10-16-1406 (7)(b) does not affect the authority of the1
board to establish an upper payment limit for the A prescription drug.2
(5) An upper payment limit applies to all purchases of and payer3
reimbursements for a prescription drug that is dispensed or administered4
to individuals in the state in person, by mail, or by other means and for5
which an upper payment limit is established. The board shall promulgate6
rules that establish
UPPER PAYMENT LIMITS AND the effective date of any7
upper payment limit established by the board, which effective date is at8
least six months after the adoption of the upper payment limit by the9
board and applies only to purchases, contracts, and plans that are issued10
on or renewed after the effective date.11
SECTION 6. In Colorado Revised Statutes, 10-16-1408, amend12
(1) and (2); and repeal (3) as follows:13
10-16-1408. Colorado prescription drug affordability review14
board - judicial review. (1) A person aggrieved by a decision of the
15
board may appeal the decision within sixty days after the decision is16
made. The board shall consider the appeal and issue a final decision17
concerning the appeal within sixty days after the board receives the18
appeal. THE FOLLOWING BOARD FUNCTIONS ARE NOT FINAL AGENCY19
ACTIONS SUBJECT TO JUDICIAL REVIEW UNDER THE "STATE20
A
DMINISTRATIVE PROCEDURE ACT", ARTICLE 4 OF TITLE 24:21
(a) I
DENTIFICATION OF ELIGIBLE PRESCRIPTION DRUGS PURSUANT22
TO SECTION 10-16-1406 (1);23
(b) S
ELECTION OF A PRESCRIPTION DRUG PURSUANT TO SECTION24
10-16-1406
(2); AND25
(c) D
ETERMINATION THAT A PRESCRIPTION DRUG IS26
UNAFFORDABLE PURSUANT TO SECTION 10-16-1406 (3).27
1225
-7- (2) Not later than March 31, 2022, the board shall promulgate1
rules establishing a process and timeline for the consideration by the2
board of any appeal that is submitted to the board pursuant to subsection3
(1) of this section. The process and timeline must comport with the "State4
Administrative Procedure Act", article 4 of title 24 A RULE OF THE BOARD5
ESTABLISHING AN UPPER PAYMENT LIMIT IS A FINAL AGENCY ACTION6
SUBJECT TO JUDICIAL REVIEW UNDER THE "STATE ADMINISTRATIVE7
P
ROCEDURE ACT", ARTICLE 4 OF TITLE 24. A PARTY SEEKING JUDICIAL8
REVIEW OF A RULE ESTABLISHING AN UPPER PAYMENT LIMIT MAY SEEK9
REVIEW OF WHETHER THE PRESCRIPTION DRUG SATISFIES THE NECESSARY10
CRITERIA IN SECTION 10-16-1406 TO BE ELIGIBLE FOR AN UPPER PAYMENT11
LIMIT.12
(3) In the absence of an appeal, a decision of the board becomes
13
final and ripe for judicial review after sixty days. Any person aggrieved14
by a final decision of the board may petition for judicial review pursuant15
to section 24-4-106.16
SECTION 7. In Colorado Revised Statutes, 10-16-1414, amend17
(1) introductory portion, (1)(b), and (1)(e) as follows:18
10-16-1414. Reports. (1) Notwithstanding section 24-1-13619
(11)(a), on or before July 1, 2023, and on or before July 1 each year20
thereafter, the board shall submit a report to the governor, the health and21
insurance committee of the house of representatives, and the health and22
human services committee of the senate, or to any successor committees,23
summarizing the activities WORK of the board during the preceding24
calendar year. At a minimum, the report must include:25
(b) The number of prescription drugs that were subjected to an26
affordability review by the board pursuant to section 10-16-1406,27
1225
-8- including the results of each affordability review; and the number and1
disposition of any appeals or judicial reviews of the board's decisions;2
(e) A summary of any appeals JUDICIAL REVIEWS of board3
decisions, that were considered by the board pursuant to section4
10-16-1408, including an indication of the outcome of any such appeal5
JUDICIAL REVIEW;6
SECTION 8. In Colorado Revised Statutes, amend 10-16-14167
as follows:8
10-16-1416. Repeal of part. This part 14 is repealed, effective9
September 1, 2026 SEPTEMBER 1, 2031. Before the repeal, the functions10
of the board are scheduled for review in accordance with section11
24-34-104.12
SECTION 9. In Colorado Revised Statutes, 24-34-104, repeal13
(27)(a)(XIX); and add (32)(a)(X) as follows:14
24-34-104. General assembly review of regulatory agencies15
and functions for repeal, continuation, or reestablishment - legislative16
declaration - repeal. (27) (a) The following agencies, functions, or both,17
are scheduled for repeal on September 1, 2026:18
(XIX) The Colorado prescription drug affordability review board19
created in section 10-16-1402.20
(32) (a) The following agencies, functions, or both, are scheduled21
for repeal on September 1, 2031:22
(X) T
HE COLORADO PRESCRIPTION DRUG AFFORDABILITY REVIEW23
BOARD CREATED IN SECTION 10-16-1402.24
SECTION 10. In Colorado Revised Statutes, 10-16-113.5,25
amend (2)(a)(III) and (2)(a)(IV); and add (2)(a)(V) as follows:26
10-16-113.5. Independent external review of adverse27
1225
-9- determinations - legislative declaration - definitions - rules. (2) As1
used in this section, unless the context otherwise requires:2
(a) "Adverse determination" means a denial of:3
(III) A request for benefits on the grounds that the treatment or4
services are experimental or investigational; or5
(IV) A benefit as described in section 10-16-113 (1)(c);
OR6
(V) A
REQUEST FOR BENEFITS FOR A PRESCRIPTION DRUG THAT IS7
UNAVAILABLE IN THE STATE BECAUSE A M ANUFACTURER HAS WITHDRAWN8
THE PRESCRIPTION DRUG FROM SALE OR DISTRIBUTION WITHIN THE STATE9
UNDER SECTION 10-16-1412.10
SECTION 11. Act subject to petition - effective date. Section11
4 of this act takes effect January 1, 2025, and the remainder of this act12
takes effect at 12:01 a.m. on the day following the expiration of the13
ninety-day period after final adjournment of the general assembly; except14
that, if a referendum petition is filed pursuant to section 1 (3) of article V15
of the state constitution against this act or an item, section, or part of this16
act within such period, then the act, item, section, or part will not take17
effect unless approved by the people at the general election to be held in18
November 2024 and, in such case, will take effect on the date of the19
official declaration of the vote thereon by the governor; except that20
section 4 of this act takes effect January 1, 2026.21
1225
-10-