HOUSE BILL 23-1225
BY REPRESENTATIVE(S) 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, McCormick, McLachlan,
Michaelson Jenet, Ortiz, Ricks, Sharbini, Sirota, Snyder, Story, Titone,
Velasco, Vigil, Weissman, Woodrow, Young, McCluskie;
also SENATOR(S) Jaquez Lewis and Buckner, Coleman, Cutter, Priola.
C
ONCERNING THE PRESCRIPTION DRUG AFFORDABILITY BOARD , AND, IN
CONNECTION THEREWITH
, MODIFYING THE AFFORDABILITY REVIEW
PROCESS
, ALLOWING THE BOARD TO ESTABLISH UPPER PAYMENT
LIMITS FOR AN ADDITIONAL NUMBER OF PRESCRIPTION DRUGS
,
CLARIFYING WHICH BOARD FUNCTIONS ARE SUBJECT TO JUDICIAL
REVIEW
, AUTHORIZING AN INDIVIDUAL TO REQUEST AN INDEPENDENT
EXTERNAL REVIEW OF A DENIAL OF A REQUEST FOR BENEFITS FOR A
PRESCRIPTION DRUG THAT HAS BEEN WITHDRAWN FROM SALE OR
DISTRIBUTION IN THE STATE
, AND EXTENDING THE REPEAL DATE OF
THE BOARD
.
Be it enacted by the General Assembly of the State of Colorado:
SECTION 1. In Colorado Revised Statutes, 10-16-1401, add (7.5)
NOTE: This bill has been prepared for the signatures of the appropriate legislative
officers and the Governor. To determine whether the Governor has signed the bill
or taken other action on it, please consult the legislative status sheet, the legislative
history, or the Session Laws.
________
Capital letters or bold & italic numbers indicate new material added to existing law; dashes
through words or numbers indicate deletions from existing law and such material is not part of
the act. as follows:
10-16-1401. Definitions. As used in this part 14, unless the context
otherwise requires:
(7.5) "B
OARD ACTIVITY" MEANS:
(a) S
ELECTING PRESCRIPTION DRUGS FOR AN AFFORDABILITY REVIEW
PURSUANT TO SECTION
10-16-1406 (2);
(b) D
ETERMINING WHETHER A PRESCRIPTION DRUG IS
UNAFFORDABLE PURSUANT TO SECTION
10-16-1406 (3);
(c) S
ELECTING 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.
SECTION 2. In Colorado Revised Statutes, 10-16-1402, amend
(3)(c) as follows:
10-16-1402. Colorado prescription drug affordability review
board - created - membership - terms - conflicts of interest.
(3) (c) (I) Board members staff members, and contractors of the division,
on behalf of the board, shall recuse themselves from any board activity OR
VOTE
in any case in which they have a conflict of interest.
(II) S
TAFF 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) N
OTWITHSTANDING 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
PAGE 2-HOUSE BILL 23-1225 CONTRACTOR TO RECUSE THEMSELVES BASED ON THE CONFLICT OF
INTEREST
.
SECTION 3. In Colorado Revised Statutes, 10-16-1404, amend (1)
as follows:
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.
SECTION 4. In Colorado Revised Statutes, 10-16-1406, amend (1)
introductory portion, (1)(a), (1)(b), and (2) introductory portion; repeal
(1)(c); and add (8) as follows:
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: any prescription drug that is:
(a) A brand-name drug or biological product that, as adjusted
annually for inflation, has ANY PRESCRIPTION DRUG THAT HAS:
(I) An initial A wholesale acquisition cost of thirty THREE thousand
dollars or more; for a twelve-month supply or for a course of treatment that
is less than twelve months in duration; or
(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 in the wholesale acquisition cost of ten percent or
more during AN INCREASE OF TWO HUNDRED PERCENT OR MORE ABOVE THE
WHOLESALE ACQUISITION COST FOR THE PRESCRIPTION DRUG IN
the
immediately
preceding twelve months; for a twelve-month supply or for a
course of treatment that is less than twelve months in duration; OR
PAGE 3-HOUSE BILL 23-1225 (III) A CURRENT WHOLESALE ACQUISITION COST FOR AN AVERAGE
COURSE OF TREATMENT PER PERSON PER YEAR OF THIRTY THOUSAND
DOLLARS OR MORE
; AND
(b) A 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. or (c) A generic drug:
(I) That, as adjusted annually for inflation, has a wholesale
acquisition cost of one hundred dollars or more for:
(A) A thirty-day supply based on the recommended dosage approved
for labeling by the FDA;
(B) A supply that lasts less than thirty days based on the
recommended dosage approved for labeling by the FDA; or
(C) One dose of the generic drug if the labeling approved by the
FDA does not recommend a finite dosage; and
(II) For which the wholesale acquisition cost increased by two
hundred percent or more during the immediately preceding twelve months,
as determined by comparing the current wholesale acquisition cost to the
average wholesale acquisition cost reported during the immediately
preceding twelve months.
(2) After identifying prescription drugs as described in subsection
(1) of this section, the board shall determine whether to conduct an
affordability review for each
AN identified prescription drug by:
(8) T
HE 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
.
SECTION 5. In Colorado Revised Statutes, 10-16-1407, amend (1)
and (5) as follows:
PAGE 4-HOUSE BILL 23-1225 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 the
A prescription drug.
(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.
SECTION 6. In Colorado Revised Statutes, 10-16-1408, amend (1)
and (2); and repeal (3) as follows:
10-16-1408. Colorado prescription drug affordability review
board - judicial review. (1) A person aggrieved by a decision of the board
may appeal the decision within sixty days after the decision is made. The
PAGE 5-HOUSE BILL 23-1225 board shall consider the appeal and issue a final decision concerning the
appeal within sixty days after the board receives the appeal. 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) I
DENTIFICATION OF ELIGIBLE PRESCRIPTION DRUGS PURSUANT TO
SECTION
10-16-1406 (1);
(b) S
ELECTION OF A PRESCRIPTION DRUG PURSUANT TO SECTION
10-16-1406 (2); AND
(c) DETERMINATION THAT A PRESCRIPTION DRUG IS UNAFFORDABLE
PURSUANT TO SECTION
10-16-1406 (3).
(2) Not later than March 31, 2022, the board shall promulgate rules
establishing a process and timeline for the consideration by the board of any
appeal that is submitted to the board pursuant to subsection (1) of this
section. The process and timeline must comport with the "State
Administrative Procedure Act", article 4 of title 24 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) In the absence of an appeal, a decision of the board becomes
final and ripe for judicial review after sixty days. Any person aggrieved by
a final decision of the board may petition for judicial review pursuant to
section 24-4-106.
SECTION 7. In Colorado Revised Statutes, 10-16-1414, amend (1)
introductory portion, (1)(b), and (1)(e) as follows:
10-16-1414. Reports. (1) Notwithstanding section 24-1-136
(11)(a), on or before July 1, 2023, and on or before July 1 each year
thereafter, the board shall submit a report to the governor, the health and
insurance committee of the house of representatives, and the health and
PAGE 6-HOUSE BILL 23-1225 human services committee of the senate, or to any successor committees,
summarizing the activities WORK of the board during the preceding calendar
year. At a minimum, the report must include:
(b) The number of prescription drugs that were subjected to an
affordability review by the board pursuant to section 10-16-1406, including
the results of each affordability review; and the number and disposition of
any appeals or judicial reviews of the board's decisions;
(e) A summary of any appeals JUDICIAL REVIEWS of board decisions,
that were considered by the board pursuant to section 10-16-1408, including
an indication of the outcome of any such appeal JUDICIAL REVIEW;
SECTION 8. In Colorado Revised Statutes, amend 10-16-1416 as
follows:
10-16-1416. Repeal of part. This part 14 is repealed, effective
September 1, 2026 SEPTEMBER 1, 2031. Before the repeal, the functions of
the board are scheduled for review in accordance with section 24-34-104.
SECTION 9. In Colorado Revised Statutes, 24-34-104, repeal
(27)(a)(XIX); and add (32)(a)(X) as follows:
24-34-104. General assembly review of regulatory agencies and
functions for repeal, continuation, or reestablishment - legislative
declaration - repeal. (27) (a) The following agencies, functions, or both,
are scheduled for repeal on September 1, 2026:
(XIX) The Colorado prescription drug affordability review board
created in section 10-16-1402.
(32) (a) The following agencies, functions, or both, are scheduled
for repeal on September 1, 2031:
(X) T
HE COLORADO PRESCRIPTION DRUG AFFORDABILITY REVIEW
BOARD CREATED IN SECTION
10-16-1402.
SECTION 10. In Colorado Revised Statutes, 10-16-113.5, amend
(2)(a)(III) and (2)(a)(IV); and add (2)(a)(V) as follows:
PAGE 7-HOUSE BILL 23-1225 10-16-113.5. Independent external review of adverse
determinations - legislative declaration - definitions - rules. (2) As used
in this section, unless the context otherwise requires:
(a) "Adverse determination" means a denial of:
(III) A request for benefits on the grounds that the treatment or
services are experimental or investigational; or
(IV) A benefit as described in section 10-16-113 (1)(c); OR
(V) 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
UNDER SECTION
10-16-1412.
SECTION 11. Act subject to petition - effective date. Section 4
of this act takes effect January 1, 2025, and the remainder of this act takes
effect at 12:01 a.m. on the day following the expiration of the ninety-day
period after final adjournment of the general assembly; except that, if a
referendum petition is filed pursuant to section 1 (3) of article V of the state
constitution against this act or an item, section, or part of this act within
such period, then the act, item, section, or part will not take effect unless
approved by the people at the general election to be held in November 2024
PAGE 8-HOUSE BILL 23-1225 and, in such case, will take effect on the date of the official declaration of
the vote thereon by the governor; except that section 4 of this act takes
effect January 1, 2026.
____________________________ ____________________________
Julie McCluskie Steve Fenberg
SPEAKER OF THE HOUSE PRESIDENT OF
OF REPRESENTATIVES THE SENATE
____________________________ ____________________________
Robin Jones Cindi L. Markwell
CHIEF CLERK OF THE HOUSE SECRETARY OF
OF REPRESENTATIVES THE SENATE
APPROVED________________________________________
(Date and Time)
_________________________________________
Jared S. Polis
GOVERNOR OF THE STATE OF COLORADO
PAGE 9-HOUSE BILL 23-1225