First Regular Session
Seventy-fourth General Assembly
STATE OF COLORADO
INTRODUCED
LLS NO. 23-0867.01 Richard Sweetman x4333
HOUSE BILL 23-1225
House Committees Senate Committees
Health & Insurance
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 UNLIMITED NUMBER OF PRESCRIPTION104
DRUGS, CLARIFYING WHICH BOARD FUNCTIONS ARE SUBJECT TO105
JUDICIAL REVIEW, AUTHORIZING AN INDIVIDUAL TO REQUEST AN106
INDEPENDENT EXTERNAL REVIEW OF A DENIAL OF A REQUEST107
FOR BENEFITS FOR A PRESCRIPTION DRUG THAT HAS BEEN108
WITHDRAWN FROM SALE OR DISTRIBUTION IN THE STATE , AND109
EXTENDING THE REPEAL DATE OF THE BOARD .110
Bill Summary
(Note: This summary applies to this bill as introduced and does
HOUSE SPONSORSHIP
deGruy Kennedy and Dickson,
SENATE SPONSORSHIP
Jaquez Lewis,
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. 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
HB23-1225-2- 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) Board members staff members, and contractors of the division, on
16
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
SECTION 3. In Colorado Revised Statutes, 10-16-1404, amend19
(1) as follows:20
10-16-1404. Colorado prescription drug affordability review21
board meetings - required to be public - exceptions. (1) The board22
shall hold its first meeting within six weeks after all of the board23
members are appointed and shall meet at least every six weeks thereafter24
to review prescription drugs; except that the chair may cancel or postpone25
a meeting if the board has no prescription drugs to review
OR FOR GOOD26
CAUSE.27
HB23-1225
-3- SECTION 4. In Colorado Revised Statutes, 10-16-1406, amend1
(1) and (2) introductory portion; and add (8) as follows:2
10-16-1406. Colorado prescription drug affordability review3
board - affordability reviews of prescription drugs. (1) The board may4
conduct affordability reviews of prescription drugs in accordance with5
this section. The board shall identify, for purposes of determining whether6
to conduct an affordability review: any prescription drug that is:7
(a) A brand-name drug or biological product that, as adjusted8
annually for inflation, has ANY PRESCRIPTION DRUG THAT HAS:9
(I) An initial A wholesale acquisition cost of thirty THREE10
thousand dollars or more; for a twelve-month supply or for a course of11
treatment that is less than twelve months in duration; or12
(I.5) A
N INCREASE OF THREE HUNDRED DOLLARS OR MORE ABOVE13
THE WHOLESALE ACQUISITION COST FOR THE PRESCRIPTION DRUG IN THE14
PRECEDING TWELVE MONTHS ;15
(II) An increase in the wholesale acquisition cost of ten percent
16
or more during AN INCREASE OF TWO HUNDRED PERCENT OR MORE ABOVE17
THE WHOLESALE ACQUISITION COST FOR THE PRESCRIPTION DRUG IN the18
immediately preceding twelve months; for a twelve-month supply or for19
a course of treatment that is less than twelve months in duration; OR20
(III) A
CURRENT WHOLESALE ACQUISITION COST FOR AN AVERAGE21
COURSE OF TREATMENT PER PERSON PER YEAR OF THIRTY THOUSAND22
DOLLARS OR MORE.23
(b) A biosimilar drug that has an initial wholesale acquisition cost24
that is not at least fifteen percent lower than
THE WHOLESALE25
ACQUISITION COST OF the corresponding biological product; or
AND26
(c) A generic drug: OTHER PRESCRIPTION DRUGS THAT ARE27
HB23-1225
-4- REFERRED TO THE BOARD AS POSING POTENTIAL AFFORDABILITY1
CHALLENGES.2
(I) That, as adjusted annually for inflation, has a wholesale3
acquisition cost of one hundred dollars or more for:4
(A) A thirty-day supply based on the recommended dosage5
approved for labeling by the FDA;6
(B) A supply that lasts less than thirty days based on the7
recommended dosage approved for labeling by the FDA; or8
(C) One dose of the generic drug if the labeling approved by the9
FDA does not recommend a finite dosage; and10
(II) For which the wholesale acquisition cost increased by two11
hundred percent or more during the immediately preceding twelve12
months, as determined by comparing the current wholesale acquisition13
cost to the average wholesale acquisition cost reported during the14
immediately preceding twelve months.15
(2) After identifying prescription drugs as described in subsection16
(1) of this section, the board shall determine whether to conduct an17
affordability review for each AN identified prescription drug by:18
(8) T
HE BOARD SHALL ISSUE A REPORT SUMMARIZING , TO THE19
EXTENT PERMITTED BY SECTION 10-16-1404 (3), THE DATA THAT THE20
BOARD CONSIDERED IN MAKING THE BOARD 'S DETERMINATION AS TO21
WHETHER A PRESCRIPTION DRUG IS UNAFFORDABLE . THE BOARD SHALL22
MAKE THE REPORT AVAILABLE ON ITS PUBLIC WEB PAGE .23
SECTION 5. In Colorado Revised Statutes, 10-16-1407, amend24
(1) and (5) as follows:25
10-16-1407. Colorado prescription drug affordability review26
board - upper payment limits for certain prescription drugs - rules27
HB23-1225
-5- - severability. (1) The board may establish an upper payment limit for1
any prescription drug for which the board has performed an affordability2
review pursuant to section 10-16-1406 and determined that the use of the3
prescription drug is unaffordable for Colorado consumers. except that the4
board may not establish an upper payment limit for more than twelve5
prescription drugs in each calendar year for three years beginning April6
1, 2022. The failure of an entity to provide information to the board7
pursuant to section 10-16-1406 (7)(b) does not affect the authority of the8
board to establish an upper payment limit for the prescription drug.9
(5) An upper payment limit applies to all purchases of and payer10
reimbursements for a prescription drug that is dispensed or administered11
to individuals in the state in person, by mail, or by other means and for12
which an upper payment limit is established. The board shall promulgate13
rules that establish
UPPER PAYMENT LIMITS AND the effective date of any14
upper payment limit established by the board, which effective date is at15
least six months after the adoption of the upper payment limit by the16
board and applies only to purchases, contracts, and plans that are issued17
on or renewed after the effective date.18
SECTION 6. In Colorado Revised Statutes, 10-16-1408, amend19
(1) and (2); and repeal (3) as follows:20
10-16-1408. Colorado prescription drug affordability review21
board - judicial review. (1) A person aggrieved by a decision of the
22
board may appeal the decision within sixty days after the decision is23
made. The board shall consider the appeal and issue a final decision24
concerning the appeal within sixty days after the board receives the25
appeal. THE FOLLOWING BOARD FUNCTIONS ARE NOT FINAL AGENCY26
ACTIONS SUBJECT TO JUDICIAL REVIEW UNDER THE "STATE27
HB23-1225
-6- ADMINISTRATIVE PROCEDURE ACT", ARTICLE 4 OF TITLE 24:1
(a) I
DENTIFICATION OF ELIGIBLE PRESCRIPTION DRUGS PURSUANT2
TO SECTION 10-16-1406 (1);3
(b) S
ELECTION OF A PRESCRIPTION DRUG PURSUANT TO SECTION4
10-16-1406
(2); AND5
(c) D
ETERMINATION THAT A PRESCRIPTION DRUG IS6
UNAFFORDABLE PURSUANT TO SECTION 10-16-1406 (3).7
(2) Not later than March 31, 2022, the board shall promulgate
8
rules establishing a process and timeline for the consideration by the9
board of any appeal that is submitted to the board pursuant to subsection10
(1) of this section. The process and timeline must comport with the "State11
Administrative Procedure Act", article 4 of title 24 A RULE OF THE BOARD12
ESTABLISHING AN UPPER PAYMENT LIMIT IS A FINAL AGENCY ACTION13
SUBJECT TO JUDICIAL REVIEW UNDER THE "STATE ADMINISTRATIVE14
P
ROCEDURE ACT", ARTICLE 4 OF TITLE 24. A PARTY SEEKING JUDICIAL15
REVIEW OF A RULE ESTABLISHING AN UPPER PAYMENT LIMIT MAY SEEK16
REVIEW OF WHETHER THE PRESCRIPTION DRUG SATISFIES THE NECESSARY17
CRITERIA IN SECTION 10-16-1406 TO BE ELIGIBLE FOR AN UPPER PAYMENT18
LIMIT.19
(3) In the absence of an appeal, a decision of the board becomes
20
final and ripe for judicial review after sixty days. Any person aggrieved21
by a final decision of the board may petition for judicial review pursuant22
to section 24-4-106.23
SECTION 7. In Colorado Revised Statutes, 10-16-1414, amend24
(1) introductory portion, (1)(b), and (1)(e) as follows:25
10-16-1414. Reports. (1) Notwithstanding section 24-1-13626
(11)(a), on or before July 1, 2023, and on or before July 1 each year27
HB23-1225
-7- thereafter, the board shall submit a report to the governor, the health and1
insurance committee of the house of representatives, and the health and2
human services committee of the senate, or to any successor committees,3
summarizing the activities WORK of the board during the preceding4
calendar year. At a minimum, the report must include:5
(b) The number of prescription drugs that were subjected to an6
affordability review by the board pursuant to section 10-16-1406,7
including the results of each affordability review; and the number and8
disposition of any appeals or judicial reviews of the board's decisions;9
(e) A summary of any appeals JUDICIAL REVIEWS of board10
decisions, that were considered by the board pursuant to section11
10-16-1408, including an indication of the outcome of any such appeal12
JUDICIAL REVIEW;13
SECTION 8. In Colorado Revised Statutes, amend 10-16-141614
as follows:15
10-16-1416. Repeal of part. This part 14 is repealed, effective16
September 1, 2026 SEPTEMBER 1, 2031. Before the repeal, the functions17
of the board are scheduled for review in accordance with section18
24-34-104.19
SECTION 9. In Colorado Revised Statutes, 24-34-104, repeal20
(27)(a)(XIX); and add (32)(a)(X) as follows:21
24-34-104. General assembly review of regulatory agencies22
and functions for repeal, continuation, or reestablishment - legislative23
declaration - repeal. (27) (a) The following agencies, functions, or both,24
are scheduled for repeal on September 1, 2026:25
(XIX) The Colorado prescription drug affordability review board26
created in section 10-16-1402.27
HB23-1225
-8- (32) (a) The following agencies, functions, or both, are scheduled1
for repeal on September 1, 2031:2
(X) T
HE COLORADO PRESCRIPTION DRUG AFFORDABILITY REVIEW3
BOARD CREATED IN SECTION 10-16-1402.4
SECTION 10. In Colorado Revised Statutes, 10-16-113.5,5
amend (2)(a)(III) and (2)(a)(IV); and add (2)(a)(V) as follows:6
10-16-113.5. Independent external review of adverse7
determinations - legislative declaration - definitions - rules. (2) As8
used in this section, unless the context otherwise requires:9
(a) "Adverse determination" means a denial of:10
(III) A request for benefits on the grounds that the treatment or11
services are experimental or investigational; or
12
(IV) A benefit as described in section 10-16-113 (1)(c);
OR13
(V) A
REQUEST FOR BENEFITS FOR A PRESCRIPTION DRUG THAT IS14
UNAVAILABLE IN THE STATE BECAUSE A M ANUFACTURER HAS WITHDRAWN15
THE PRESCRIPTION DRUG FROM SALE OR DISTRIBUTION WITHIN THE STATE16
UNDER SECTION 10-16-1412.17
SECTION 11. Act subject to petition - effective date. This act18
takes effect at 12:01 a.m. on the day following the expiration of the19
ninety-day period after final adjournment of the general assembly; except20
that, if a referendum petition is filed pursuant to section 1 (3) of article V21
of the state constitution against this act or an item, section, or part of this22
act within such period, then the act, item, section, or part will not take23
effect unless approved by the people at the general election to be held in24
November 2024 and, in such case, will take effect on the date of the25
official declaration of the vote thereon by the governor.26
HB23-1225
-9-