Colorado 2023 Regular Session

Colorado House Bill HB1225 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
	1	+	First Regular Session
	2	+	Seventy-fourth General Assembly
	3	+	STATE OF COLORADO
	4	+	REREVISED
	5	+	This Version Includes All Amendments
	6	+	Adopted in the Second House
	7	+	LLS NO. 23-0867.01 Richard Sweetman x4333
1	8		HOUSE BILL 23-1225
2		-	BY REPRESENTATIVE(S) deGruy Kennedy and Dickson, Amabile,
3		-	Bacon, Bird, Brown, Duran, English, Epps, Froelich, Garcia,
4		-	Gonzales-Gutierrez, Hamrick, Herod, Jodeh, Joseph, Kipp, Lieder, Lindsay,
5		-	Lindstedt, Lukens, Mabrey, Mauro, McCormick, McLachlan,
6		-	Michaelson Jenet, Ortiz, Ricks, Sharbini, Sirota, Snyder, Story, Titone,
7		-	Velasco, Vigil, Weissman, Woodrow, Young, McCluskie;
8		-	also SENATOR(S) Jaquez Lewis and Buckner, Coleman, Cutter, Priola.
	9	+	House Committees Senate Committees
	10	+	Health & Insurance Health & Human Services
	11	+	A BILL FOR AN ACT
9	12		C
10		-	ONCERNING THE PRESCRIPTION DRUG AFFORDABILITY BOARD , AND, IN
11		-	CONNECTION THEREWITH
12		-	, MODIFYING THE AFFORDABILITY REVIEW
13		-	PROCESS
14		-	, ALLOWING THE BOARD TO ESTABLISH UPPER PAYMENT
15		-	LIMITS FOR AN ADDITIONAL NUMBER OF PRESCRIPTION DRUGS
16		-	,
17		-	CLARIFYING WHICH BOARD FUNCTIONS ARE SUBJECT TO JUDICIAL
18		-	REVIEW
19		-	, AUTHORIZING AN INDIVIDUAL TO REQUEST AN INDEPENDENT
20		-	EXTERNAL REVIEW OF A DENIAL OF A REQUEST FOR BENEFITS FOR A
21		-	PRESCRIPTION DRUG THAT HAS BEEN WITHDRAWN FROM SALE OR
22		-	DISTRIBUTION IN THE STATE
23		-	, AND EXTENDING THE REPEAL DATE OF
24		-	THE BOARD
25		-	.
26		-
27		-	Be it enacted by the General Assembly of the State of Colorado:
28		-	SECTION 1. In Colorado Revised Statutes, 10-16-1401, add (7.5)
29		-	NOTE: This bill has been prepared for the signatures of the appropriate legislative
30		-	officers and the Governor. To determine whether the Governor has signed the bill
31		-	or taken other action on it, please consult the legislative status sheet, the legislative
32		-	history, or the Session Laws.
33		-	________
34		-	Capital letters or bold & italic numbers indicate new material added to existing law; dashes
35		-	through words or numbers indicate deletions from existing law and such material is not part of
36		-	the act. as follows:
37		-	10-16-1401. Definitions. As used in this part 14, unless the context
38		-	otherwise requires:
	13	+	ONCERNING THE PRESCRIPTIO N DRUG AFFORDABILITY BOARD , AND,101
	14	+	IN CONNECTION THEREWITH , MODIFYING THE AFFORDABILITY102
	15	+	REVIEW PROCESS, ALLOWING THE BOARD TO ESTABLISH UPPER103
	16	+	PAYMENT LIMITS FOR AN ADDITIONAL
	17	+	NUMBER OF104
	18	+	PRESCRIPTION DRUGS, CLARIFYING WHICH BOARD FUNCTIONS105
	19	+	ARE SUBJECT TO JUDICIAL REVIEW , AUTHORIZING AN106
	20	+	INDIVIDUAL TO REQUEST AN I NDEPENDENT EXTERNAL REVIEW107
	21	+	OF A DENIAL OF A REQUEST FOR BENEFITS FOR A PRESCRIPTION108
	22	+	DRUG THAT HAS BEEN WITHDRAWN FROM SALE OR109
	23	+	DISTRIBUTION IN THE STATE, AND EXTENDING THE REPEAL DATE110
	24	+	OF THE BOARD.111
	25	+	Bill Summary
	26	+	SENATE
	27	+	3rd Reading Unamended
	28	+	April 24, 2023
	29	+	SENATE
	30	+	Amended 2nd Reading
	31	+	April 21, 2023
	32	+	HOUSE
	33	+	3rd Reading Unamended
	34	+	March 21, 2023
	35	+	HOUSE
	36	+	Amended 2nd Reading
	37	+	March 20, 2023
	38	+	HOUSE SPONSORSHIP
	39	+	deGruy Kennedy and Dickson, Amabile, Bacon, Bird, Brown, Duran, English, Epps,
	40	+	Froelich, Garcia, Gonzales-Gutierrez, Hamrick, Herod, Jodeh, Joseph, Kipp, Lieder, Lindsay,
	41	+	Lindstedt, Lukens, Mabrey, Mauro, McCluskie, McCormick, McLachlan, Michaelson Jenet,
	42	+	Ortiz, Ricks, Sharbini, Sirota, Snyder, Story, Titone, Velasco, Vigil, Weissman, Woodrow,
	43	+	Young
	44	+	SENATE SPONSORSHIP
	45	+	Jaquez Lewis and Buckner, Coleman, Cutter, Priola
	46	+	Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment.
	47	+	Capital letters or bold & italic numbers indicate new material to be added to existing law.
	48	+	Dashes through the words or numbers indicate deletions from existing law. (Note: This summary applies to this bill as introduced and does
	49	+	not reflect any amendments that may be subsequently adopted. If this bill
	50	+	passes third reading in the house of introduction, a bill summary that
	51	+	applies to the reengrossed version of this bill will be available at
	52	+	http://leg.colorado.gov
	53	+	.)
	54	+	In 2021, the general assembly enacted SB 21-175, which created
	55	+	the prescription drug affordability board (board) in the division of
	56	+	insurance (division) and an affordability review process whereby the
	57	+	board may review costs associated with, and establish upper payment
	58	+	limits for, certain prescription drugs. The bill makes certain changes
	59	+	concerning the board.
	60	+	Section 1 defines "board activity", and section 2 states that only
	61	+	board members, and not staff members or contractors of the division, are
	62	+	required to recuse themselves from any board activity or vote where they
	63	+	have a conflict of interest.
	64	+	Section 3 allows the chair of the board to cancel or postpone a
	65	+	board meeting for good cause.
	66	+	Section 4 makes certain changes to the procedure by which the
	67	+	board identifies prescription drugs that may be subjected to an
	68	+	affordability review. Section 4 also requires the board to report on its
	69	+	public web page certain information regarding its considerations.
	70	+	Section 5 removes language prohibiting the board from
	71	+	establishing an upper payment limit for more than 12 prescription drugs
	72	+	within a specified period.
	73	+	Section 6 establishes that an upper payment limit for a prescription
	74	+	drug is not a final agency action that is subject to judicial review until the
	75	+	board promulgates a rule establishing the upper payment limit.
	76	+	Sections 6 and 7 remove certain language describing an appeals
	77	+	process for appealing decisions of the board.
	78	+	Sections 8 and 9 extend the repeal and associated sunset review
	79	+	of the board from September 1, 2026, to September 1, 2031.
	80	+	Section 10 establishes that a denial of a request for benefits for a
	81	+	prescription drug that is unavailable in the state because a manufacturer
	82	+	has withdrawn the prescription drug from sale or distribution within the
	83	+	state is an "adverse determination" for which an individual may request
	84	+	an independent external review.
	85	+	Be it enacted by the General Assembly of the State of Colorado:1
	86	+	SECTION 1. In Colorado Revised Statutes, 10-16-1401, add2
	87	+	(7.5) as follows:3
	88	+	10-16-1401. Definitions. As used in this part 14, unless the4
	89	+	1225-2- context otherwise requires:1
39	90		(7.5) "B
40		-	OARD ACTIVITY" MEANS:
	91	+	OARD ACTIVITY" MEANS:2
41	92		(a) S
42		-	ELECTING PRESCRIPTION DRUGS FOR AN AFFORDABILITY REVIEW
43		-	PURSUANT TO SECTION
44		-	10-16-1406 (2);
	93	+	ELECTING PRESCRIPTION DRUGS FOR AN AFFORDABILITY3
	94	+	REVIEW PURSUANT TO SECTION 10-16-1406 (2);4
45	95		(b) D
46		-	ETERMINING WHETHER A PRESCRIPTION DRUG IS
47		-	UNAFFORDABLE PURSUANT TO SECTION
48		-	10-16-1406 (3);
	96	+	ETERMINING WHETHER A PRESCRIPTION DRUG IS5
	97	+	UNAFFORDABLE PURSUANT TO SECTION 10-16-1406 (3);6
49	98		(c) S
50		-	ELECTING PRESCRIPTION DRUGS FOR WHICH THE ~~BOARD~~
51		-	ESTABLISHES AN UPPER PAYMENT LIMIT PURSUANT TO ~~SECTION~~
	99	+	ELECTING PRESCRIPTION DRUGS FOR WHICH THE BOARD7
	100	+	ESTABLISHES AN UPPER PAYMENT LIMIT PURSUANT TO SECTION8
52	101		10-16-1407;
53		-	~~AND~~
54		-	(d) ~~ESTABLISHING AN UPPER PAYMENT LIMIT FOR A PRESCRIPTION~~
55		-	~~DRUG PURSUANT TO SECTION~~
56		-	10-16-1407.
57		-	SECTION 2. In Colorado Revised Statutes, 10-16-1402, ~~amend~~
58		-	(3)(c) as follows:
59		-	10-16-1402. Colorado prescription drug affordability ~~review~~
60		-	board - created - membership - terms - conflicts of interest.
61		-	(3) (c) (I) ~~Board members staff members, and contractors of the division,~~
62		-	~~on behalf~~ of the ~~board~~, ~~shall recuse themselves from any board activity OR~~
63		-	~~VOTE~~
64		-	in any case in which they have a conflict of interest.
	102	+	AND9
	103	+	(d) E
	104	+	STABLISHING AN UPPER PAYMENT LIMIT FOR A PRESCRIPTION10
	105	+	DRUG PURSUANT TO SECTION 10-16-1407.11
	106	+	SECTION 2. In Colorado Revised Statutes, 10-16-1402, amend12
	107	+	(3)(c) as follows:13
	108	+	10-16-1402. Colorado prescription drug affordability review14
	109	+	board - created - membership - terms - conflicts of interest.15
	110	+	(3) (c) (I)
	111	+	Board members staff members, and contractors of the division,16
	112	+	on behalf of the board, shall recuse themselves from any board activity OR17
	113	+	VOTE in any case in which they have a conflict of interest.18
65	114		(II) S
66	115		TAFF MEMBERS AND CONTRACTORS OF THE DIVISION , ON
67		-	BEHALF OF THE BOARD
68		-	, SHALL DISCLOSE ANY CONFLICT OF INTEREST
69		-	RELATED TO A PRESCRIPTION DRUG FOR WHICH THE BOARD IS CONDUCTING
70		-	AN AFFORDABILITY REVIEW OR ESTABLISHING AN UPPER PAYMENT LIMIT
71		-	.
	116	+	19
	117	+	BEHALF OF THE BOARD, SHALL DISCLOSE ANY CONFLICT OF INTEREST20
	118	+	RELATED TO A PRESCRIPTION DRUG FOR WHICH THE BOARD IS CONDUCTING21
	119	+	AN AFFORDABILITY REVIEW OR ESTABLISHING AN UPPER PAYMENT LIMIT .22
72	120		(III) N
73	121		OTWITHSTANDING SUBSECTION (3)(d) OF THIS SECTION AND
74		-	THE REPORTING REQUIREMENTS SET FORTH IN SECTION
75		-	10-16-1414 (1)(f), A
76		-	CONFLICT OF INTEREST DISCLOSED BY A STAFF MEMBER OR BY A
77		-	CONTRACTOR OF THE DIVISION
78		-	, WHICH DISCLOSURE PERTAINS TO A
79		-	PERSONAL ASSOCIATION
80		-	, MUST REMAIN CONFIDENTIAL. THE BOARD, UPON
81		-	REVIEW OF SUCH A DISCLOSURE
82		-	, MAY DIRECT THE STAFF MEMBER OR
83		-	PAGE 2-HOUSE BILL 23-1225 CONTRACTOR TO RECUSE THEMSELVES BASED ON THE CONFLICT OF
84		-	INTEREST
85		-	.
86		-	SECTION 3. In Colorado Revised Statutes, 10-16-1404, amend (1)
87		-	as follows:
88		-	10-16-1404. Colorado prescription drug affordability review
89		-	board meetings - required to be public - exceptions. (1) The board shall
90		-	hold its first meeting within six weeks after all of the board members are
91		-	appointed and shall meet at least every six weeks thereafter to review
92		-	prescription drugs; except that the chair may cancel or postpone a meeting
93		-	if the board has no prescription drugs to review
94		-	OR FOR GOOD CAUSE.
95		-	SECTION 4. In Colorado Revised Statutes, 10-16-1406, amend (1)
96		-	introductory portion, (1)(a), (1)(b), and (2) introductory portion; repeal
97		-	(1)(c); and add (8) as follows:
98		-	10-16-1406. Colorado prescription drug affordability review
99		-	board - affordability reviews of prescription drugs. (1) The board may
100		-	conduct affordability reviews of prescription drugs in accordance with this
101		-	section. The board shall identify, for purposes of determining whether to
102		-	conduct an affordability review: any prescription drug that is:
103		-	(a) A brand-name drug or biological product that, as adjusted
104		-	annually for inflation, has ANY PRESCRIPTION DRUG THAT HAS:
105		-	(I) An initial A wholesale acquisition cost of thirty THREE thousand
106		-	dollars or more; for a twelve-month supply or for a course of treatment that
107		-	is less than twelve months in duration; or
108		-	(I.5) AN INCREASE OF THREE HUNDRED DOLLARS OR MORE ABOVE
109		-	THE WHOLESALE ACQUISITION COST FOR THE PRESCRIPTION DRUG IN THE
110		-	PRECEDING TWELVE MONTHS
111		-	;
112		-	(II) An increase in the wholesale acquisition cost of ten percent or
113		-	more during AN INCREASE OF TWO HUNDRED PERCENT OR MORE ABOVE THE
114		-	WHOLESALE ACQUISITION COST FOR THE PRESCRIPTION DRUG IN
115		-	the
116		-	immediately
117		-	preceding twelve months; for a twelve-month supply or for a
118		-	course of treatment that is less than twelve months in duration; OR
119		-	PAGE 3-HOUSE BILL 23-1225 (III) A CURRENT WHOLESALE ACQUISITION COST FOR AN AVERAGE
120		-	COURSE OF TREATMENT PER PERSON PER YEAR OF THIRTY THOUSAND
121		-	DOLLARS OR MORE
122		-	; AND
123		-	(b) A ANY biosimilar drug that has an initial wholesale acquisition
	122	+	23
	123	+	THE REPORTING REQUIREMENTS SET FORTH IN SECTION 10-16-1414 (1)(f),24
	124	+	A CONFLICT OF INTEREST DISCLOSED BY A STAFF MEMBER OR BY A25
	125	+	CONTRACTOR OF THE DIVISION , WHICH DISCLOSURE PERTAINS TO A26
	126	+	PERSONAL ASSOCIATION, MUST REMAIN CONFIDENTIAL. THE BOARD, UPON27
	127	+	1225
	128	+	-3- REVIEW OF SUCH A DISCLOSURE , MAY DIRECT THE STAFF MEMBER OR1
	129	+	CONTRACTOR TO RECUSE THEMSELF BASED ON THE CONFLICT OF INTEREST .2
	130	+	SECTION 3. In Colorado Revised Statutes, 10-16-1404, amend3
	131	+	(1) as follows:4
	132	+	10-16-1404. Colorado prescription drug affordability review5
	133	+	board meetings - required to be public - exceptions. (1) The board6
	134	+	shall hold its first meeting within six weeks after all of the board7
	135	+	members are appointed and shall meet at least every six weeks thereafter8
	136	+	to review prescription drugs; except that the chair may cancel or postpone9
	137	+	a meeting if the board has no prescription drugs to review
	138	+	OR FOR GOOD10
	139	+	CAUSE.11
	140	+	SECTION 4. In Colorado Revised Statutes, 10-16-1406, amend12
	141	+	(1)(a), (1)(b), and (2) introductory portion; repeal (1)(c); and add (8) as13
	142	+	follows:14
	143	+	10-16-1406. Colorado prescription drug affordability review15
	144	+	board - affordability reviews of prescription drugs. (1) The board may16
	145	+	conduct affordability reviews of prescription drugs in accordance with17
	146	+	this section. The board shall identify, for purposes of determining whether18
	147	+	to conduct an affordability review: any prescription drug that is:19
	148	+	(a) A brand-name drug or biological product that, as adjusted20
	149	+	annually for inflation, has ANY PRESCRIPTION DRUG THAT HAS:21
	150	+	(I) An initial A wholesale acquisition cost of thirty THREE22
	151	+	thousand dollars or more; for a twelve-month supply or for a course of23
	152	+	treatment that is less than twelve months in duration; or24
	153	+	(I.5) A
	154	+	N INCREASE OF THREE HUNDRED DOLLARS OR MORE ABOVE25
	155	+	THE WHOLESALE ACQUISITION COST FOR THE PRESCRIPTION DRUG IN THE26
	156	+	PRECEDING TWELVE MONTHS ;27
	157	+	1225
	158	+	-4- (II) An increase in the wholesale acquisition cost of ten percent1
	159	+	or more during AN INCREASE OF TWO HUNDRED PERCENT OR MORE ABOVE2
	160	+	THE WHOLESALE ACQUISITION COST FOR THE PRESCRIPTION DRUG IN the3
	161	+	immediately preceding twelve months; for a twelve-month supply or for4
	162	+	a course of treatment that is less than twelve months in duration; OR5
	163	+	(III) A
	164	+	CURRENT WHOLESALE ACQUISITION COST FOR AN AVERAGE6
	165	+	COURSE OF TREATMENT PER PERSON PER YEAR OF THIRTY THOUSAND7
	166	+	DOLLARS OR
	167	+	MORE; AND8
	168	+	(b) A ANY biosimilar drug that has an initial wholesale acquisition9
124	169		cost that is not at least fifteen percent lower than
125		-	THE WHOLESALE
126		-	ACQUISITION COST OF
127		-	the corresponding biological product. or (c) A generic drug:
128		-	(I) That, as adjusted annually for inflation, has a wholesale
129		-	acquisition cost of one hundred dollars or more for:
130		-	(A) A thirty-day supply based on the recommended dosage approved
131		-	for labeling by the FDA;
132		-	(B) A supply that lasts less than thirty days based on the
133		-	recommended dosage approved for labeling by the FDA; or
134		-	(C) One dose of the generic drug if the labeling approved by the
135		-	FDA does not recommend a finite dosage; and
136		-	(II) For which the wholesale acquisition cost increased by two
137		-	hundred percent or more during the immediately preceding twelve months,
138		-	as determined by comparing the current wholesale acquisition cost to the
139		-	average wholesale acquisition cost reported during the immediately
140		-	preceding twelve months.
141		-	(2) After identifying prescription drugs as described in subsection
142		-	(1) of this section, the board shall determine whether to conduct an
143		-	affordability review for each
144		-	AN identified prescription drug by:
	170	+	THE WHOLESALE10
	171	+	ACQUISITION COST OF the corresponding biological
	172	+	product. or11
	173	+	(c) A generic drug: 12
	174	+	(I) That, as adjusted annually for inflation, has a wholesale13
	175	+	acquisition cost of one hundred dollars or more for:14
	176	+	(A) A thirty-day supply based on the recommended dosage15
	177	+	approved for labeling by the FDA;16
	178	+	(B) A supply that lasts less than thirty days based on the17
	179	+	recommended dosage approved for labeling by the FDA; or18
	180	+	(C) One dose of the generic drug if the labeling approved by the19
	181	+	FDA does not recommend a finite dosage; and20
	182	+	(II) For which the wholesale acquisition cost increased by two21
	183	+	hundred percent or more during the immediately preceding twelve22
	184	+	months, as determined by comparing the current wholesale acquisition23
	185	+	cost to the average wholesale acquisition cost reported during the24
	186	+	immediately preceding twelve months.25
	187	+	(2) After identifying prescription drugs as described in subsection26
	188	+	(1) of this section, the board shall determine whether to conduct an27
	189	+	1225
	190	+	-5- affordability review for each AN identified prescription drug by:1
145	191		(8) T
146		-	HE BOARD SHALL ISSUE A REPORT SUMMARIZING , TO THE
147		-	EXTENT PERMITTED BY SECTION
148		-	10-16-1404 (3), THE DATA THAT THE BOARD
149		-	CONSIDERED IN MAKING THE BOARD
150		-	'S DETERMINATION AS TO WHETHER A
151		-	PRESCRIPTION DRUG IS UNAFFORDABLE
152		-	. THE BOARD SHALL MAKE THE
153		-	REPORT AVAILABLE ON ITS PUBLIC WEB PAGE
154		-	.
155		-	SECTION 5. In Colorado Revised Statutes, 10-16-1407, amend (1)
156		-	and (5) as follows:
157		-	PAGE 4-HOUSE BILL 23-1225 10-16-1407. Colorado prescription drug affordability review
158		-	board - upper payment limits for certain prescription drugs - rules -
159		-	severability. (1) (a) The board may establish an upper payment limit for
160		-	any prescription drug for which the board has performed an affordability
161		-	review pursuant to section 10-16-1406 and determined that the use of the
162		-	prescription drug is unaffordable for Colorado consumers; except that:
163		-	(I) The board may not establish an upper payment limit for more
164		-	than twelve prescription drugs in each calendar year for three years
	192	+	HE BOARD SHALL ISSUE A REPORT SUMMARIZING , TO THE2
	193	+	EXTENT PERMITTED BY SECTION 10-16-1404 (3), THE DATA THAT THE3
	194	+	BOARD CONSIDERED IN MAKING THE BOARD 'S DETERMINATION AS TO4
	195	+	WHETHER A PRESCRIPTION DRUG IS UNAFFORDABLE . THE BOARD SHALL5
	196	+	MAKE THE REPORT AVAILABLE ON ITS PUBLIC WEB PAGE .6
	197	+	SECTION 5. In Colorado Revised Statutes, 10-16-1407, amend7
	198	+	(1) and (5) as follows:8
	199	+	10-16-1407. Colorado prescription drug affordability review9
	200	+	board - upper payment limits for certain prescription drugs - rules10
	201	+
	202	+	- severability. (1) (a) The board may establish an upper payment11
	203	+	limit for any prescription drug for which the board has performed an12
	204	+	affordability review pursuant to section 10-16-1406 and determined that13
	205	+	the use of the prescription drug is unaffordable for Colorado consumers;14
	206	+	except that:15
	207	+	(I) The board may not establish an upper payment limit for more16
	208	+	than twelve prescription drugs in each calendar year for three years17
165	209		beginning April 1, 2022,
166		-	UNLESS THE BOARD DETERMINES THAT THERE IS A
167		-	NEED TO ESTABLISH UPPER PAYMENT LIMITS FOR MORE THAN TWELVE
168		-	PRESCRIPTION DRUGS
169		-	, IN WHICH CASE THE BOARD MAY ESTABLISH AN UPPER
170		-	PAYMENT LIMIT FOR UP TO EIGHTEEN PRESCRIPTION DRUGS SO LONG AS THE
171		-	BOARD HAS SUFFICIENT STAFF SUPPORT TO DO SO
172		-	; AND
173		-	(II) FOR EACH PRESCRIPTION DRUG FOR WHICH THE BOARD
174		-	ESTABLISHES AN UPPER PAYMENT LIMIT
175		-	, THE BOARD MAY INCLUDE MULTIPLE
176		-	NATIONAL DRUG CODES
177		-	, AS DESCRIBED IN 21 CFR 207.33, THAT ARE
178		-	INDICATED FOR THE PRESCRIPTION DRUG
179		-	.
180		-	(b) The failure of an entity to provide information to the board
181		-	pursuant to section 10-16-1406 (7)(b) does not affect the authority of the
182		-	board to establish an upper payment limit for the
183		-	A prescription drug.
184		-	(5) An upper payment limit applies to all purchases of and payer
185		-	reimbursements for a prescription drug that is dispensed or administered to
186		-	individuals in the state in person, by mail, or by other means and for which
187		-	an upper payment limit is established. The board shall promulgate rules that
188		-	establish
189		-	UPPER PAYMENT LIMITS AND the effective date of any upper
190		-	payment limit established by the board, which effective date is at least six
191		-	months after the adoption of the upper payment limit by the board and
192		-	applies only to purchases, contracts, and plans that are issued on or renewed
193		-	after the effective date.
194		-	SECTION 6. In Colorado Revised Statutes, 10-16-1408, amend (1)
195		-	and (2); and repeal (3) as follows:
196		-	10-16-1408. Colorado prescription drug affordability review
197		-	board - judicial review. (1) A person aggrieved by a decision of the board
198		-	may appeal the decision within sixty days after the decision is made. The
199		-	PAGE 5-HOUSE BILL 23-1225 board shall consider the appeal and issue a final decision concerning the
200		-	appeal within sixty days after the board receives the appeal. THE
201		-	FOLLOWING BOARD FUNCTIONS ARE NOT FINAL AGENCY ACTIONS SUBJECT TO
202		-	JUDICIAL REVIEW UNDER THE
203		-	"STATE ADMINISTRATIVE PROCEDURE ACT",
204		-	ARTICLE 4 OF TITLE 24:
	210	+	UNLESS THE BOARD DETERMINES THAT THERE IS
	211	+	18
	212	+	A NEED TO ESTABLISH UPPER PAYMENT LIMITS FOR MORE THAN TWELVE19
	213	+	PRESCRIPTION DRUGS, IN WHICH CASE THE BOARD MAY ESTABLISH AN20
	214	+	UPPER PAYMENT LIMIT FOR UP TO EIGHTEEN PRESCRIPTION DRUGS SO LONG21
	215	+	AS THE BOARD HAS SUFFICIENT STAFF SUPPORT TO DO SO ; AND22
	216	+	(II) F
	217	+	OR EACH PRESCRIPTION DRUG FOR WHICH THE BOARD
	218	+	23
	219	+	ESTABLISHES AN UPPER PAYMENT LIMIT , THE BOARD MAY INCLUDE24
	220	+	MULTIPLE NATIONAL DRUG CODES , AS DESCRIBED IN 21 CFR 207.33, THAT25
	221	+	ARE INDICATED FOR THE PRESCRIPTION DRUG .26
	222	+	(b) The failure of an entity to provide information to the board27
	223	+	1225
	224	+	-6- pursuant to section 10-16-1406 (7)(b) does not affect the authority of the1
	225	+	board to establish an upper payment limit for the A prescription drug.2
	226	+	(5) An upper payment limit applies to all purchases of and payer3
	227	+	reimbursements for a prescription drug that is dispensed or administered4
	228	+	to individuals in the state in person, by mail, or by other means and for5
	229	+	which an upper payment limit is established. The board shall promulgate6
	230	+	rules that establish
	231	+	UPPER PAYMENT LIMITS AND the effective date of any7
	232	+	upper payment limit established by the board, which effective date is at8
	233	+	least six months after the adoption of the upper payment limit by the9
	234	+	board and applies only to purchases, contracts, and plans that are issued10
	235	+	on or renewed after the effective date.11
	236	+	SECTION 6. In Colorado Revised Statutes, 10-16-1408, amend12
	237	+	(1) and (2); and repeal (3) as follows:13
	238	+	10-16-1408. Colorado prescription drug affordability review14
	239	+	board - judicial review. (1) A person aggrieved by a decision of the
	240	+	15
	241	+	board may appeal the decision within sixty days after the decision is16
	242	+	made. The board shall consider the appeal and issue a final decision17
	243	+	concerning the appeal within sixty days after the board receives the18
	244	+	appeal. THE FOLLOWING BOARD FUNCTIONS ARE NOT FINAL AGENCY19
	245	+	ACTIONS SUBJECT TO JUDICIAL REVIEW UNDER THE "STATE20
	246	+	A
	247	+	DMINISTRATIVE PROCEDURE ACT", ARTICLE 4 OF TITLE 24:21
205	248		(a) I
206		-	DENTIFICATION OF ELIGIBLE PRESCRIPTION DRUGS PURSUANT TO
207		-	SECTION
208		-	10-16-1406 (1);
	249	+	DENTIFICATION OF ELIGIBLE PRESCRIPTION DRUGS PURSUANT22
	250	+	TO SECTION 10-16-1406 (1);23
209	251		(b) S
210		-	ELECTION OF A PRESCRIPTION DRUG PURSUANT TO ~~SECTION~~
211		-	10-16-1406 ~~(2); AND~~
212		-	(c) ~~DETERMINATION THAT A PRESCRIPTION DRUG IS UNAFFORDABLE~~
213		-	~~PURSUANT TO SECTION~~
214		-	~~10-16-1406 (3).~~
215		-	(2) ~~Not later than March 31, 2022, the board shall promulgate rules~~
216		-	~~establishing a process and timeline for the consideration by the board of any~~
217		-	~~appeal that is submitted to~~ the board ~~pursuant to subsection (1) of this~~
218		-	~~section. The~~ process and timeline ~~must comport with~~ the ~~"State~~
219		-	~~Administrative Procedure Act", article 4~~ of ~~title 24 A RULE OF~~ THE BOARD
220		-	~~ESTABLISHING AN UPPER PAYMENT LIMIT IS A FINAL AGENCY ACTION~~
221		-	~~SUBJECT TO JUDICIAL REVIEW UNDER~~ THE
222		-	~~"STATE ADMINISTRATIVE~~
223		-	~~PROCEDURE ACT", ARTICLE 4 OF TITLE 24. A PARTY SEEKING~~ JUDICIAL
224		-	~~REVIEW OF A RULE ESTABLISHING AN UPPER PAYMENT LIMIT MAY SEEK~~
225		-	~~REVIEW~~ OF ~~WHETHER THE PRESCRIPTION DRUG SATISFIES THE NECESSARY~~
226		-	~~CRITERIA IN SECTION~~
227		-	~~10-16-1406 TO BE ELIGIBLE FOR AN UPPER PAYMENT~~
228		-	~~LIMIT~~
229		-	.
	252	+	ELECTION OF A PRESCRIPTION DRUG PURSUANT TO SECTION24
	253	+	10-16-1406
	254	+	(2); AND25
	255	+	(c) D
	256	+	ETERMINATION THAT A PRESCRIPTION DRUG IS26
	257	+	UNAFFORDABLE PURSUANT TO SECTION 10-16-1406 (3).27
	258	+	1225
	259	+	-7- (2) Not later than March 31, 2022, the board shall promulgate1
	260	+	rules establishing a process and timeline for the consideration by the2
	261	+	board of any appeal that is submitted to the board pursuant to subsection3
	262	+	(1) of this section. The process and timeline must comport with the "State4
	263	+	Administrative Procedure Act", article 4 of title 24 A RULE OF THE BOARD5
	264	+	ESTABLISHING AN UPPER PAYMENT LIMIT IS A FINAL AGENCY ACTION6
	265	+	SUBJECT TO JUDICIAL REVIEW UNDER THE "STATE ADMINISTRATIVE7
	266	+	P
	267	+	ROCEDURE ACT", ARTICLE 4 OF TITLE 24. A PARTY SEEKING JUDICIAL8
	268	+	REVIEW OF A RULE ESTABLISHING AN UPPER PAYMENT LIMIT MAY SEEK9
	269	+	REVIEW OF WHETHER THE PRESCRIPTION DRUG SATISFIES THE NECESSARY10
	270	+	CRITERIA IN SECTION 10-16-1406 TO BE ELIGIBLE FOR AN UPPER PAYMENT11
	271	+	LIMIT.12
230	272		(3) In the absence of an appeal, a decision of the board becomes
231		-	final and ripe for judicial review after sixty days. Any person aggrieved by
232		-	a final decision of the board may petition for judicial review pursuant to
233		-	section 24-4-106.
234		-	SECTION 7. In Colorado Revised Statutes, 10-16-1414, amend (1)
235		-	introductory portion, (1)(b), and (1)(e) as follows:
236		-	10-16-1414. Reports. (1) Notwithstanding section 24-1-136
237		-	(11)(a), on or before July 1, 2023, and on or before July 1 each year
238		-	thereafter, the board shall submit a report to the governor, the health and
239		-	insurance committee of the house of representatives, and the health and
240		-	PAGE 6-HOUSE BILL 23-1225 human services committee of the senate, or to any successor committees,
241		-	summarizing the activities WORK of the board during the preceding calendar
242		-	year. At a minimum, the report must include:
243		-	(b) The number of prescription drugs that were subjected to an
244		-	affordability review by the board pursuant to section 10-16-1406, including
245		-	the results of each affordability review; and the number and disposition of
246		-	any appeals or judicial reviews of the board's decisions;
247		-	(e) A summary of any appeals JUDICIAL REVIEWS of board decisions,
248		-	that were considered by the board pursuant to section 10-16-1408, including
249		-	an indication of the outcome of any such appeal JUDICIAL REVIEW;
250		-	SECTION 8. In Colorado Revised Statutes, amend 10-16-1416 as
251		-	follows:
252		-	10-16-1416. Repeal of part. This part 14 is repealed, effective
253		-	September 1, 2026 SEPTEMBER 1, 2031. Before the repeal, the functions of
254		-	the board are scheduled for review in accordance with section 24-34-104.
255		-	SECTION 9. In Colorado Revised Statutes, 24-34-104, repeal
256		-	(27)(a)(XIX); and add (32)(a)(X) as follows:
257		-	24-34-104. General assembly review of regulatory agencies and
258		-	functions for repeal, continuation, or reestablishment - legislative
259		-	declaration - repeal. (27) (a) The following agencies, functions, or both,
260		-	are scheduled for repeal on September 1, 2026:
261		-	(XIX) The Colorado prescription drug affordability review board
262		-	created in section 10-16-1402.
263		-	(32) (a) The following agencies, functions, or both, are scheduled
264		-	for repeal on September 1, 2031:
	273	+	13
	274	+	final and ripe for judicial review after sixty days. Any person aggrieved14
	275	+	by a final decision of the board may petition for judicial review pursuant15
	276	+	to section 24-4-106.16
	277	+	SECTION 7. In Colorado Revised Statutes, 10-16-1414, amend17
	278	+	(1) introductory portion, (1)(b), and (1)(e) as follows:18
	279	+	10-16-1414. Reports. (1) Notwithstanding section 24-1-13619
	280	+	(11)(a), on or before July 1, 2023, and on or before July 1 each year20
	281	+	thereafter, the board shall submit a report to the governor, the health and21
	282	+	insurance committee of the house of representatives, and the health and22
	283	+	human services committee of the senate, or to any successor committees,23
	284	+	summarizing the activities WORK of the board during the preceding24
	285	+	calendar year. At a minimum, the report must include:25
	286	+	(b) The number of prescription drugs that were subjected to an26
	287	+	affordability review by the board pursuant to section 10-16-1406,27
	288	+	1225
	289	+	-8- including the results of each affordability review; and the number and1
	290	+	disposition of any appeals or judicial reviews of the board's decisions;2
	291	+	(e) A summary of any appeals JUDICIAL REVIEWS of board3
	292	+	decisions, that were considered by the board pursuant to section4
	293	+	10-16-1408, including an indication of the outcome of any such appeal5
	294	+	JUDICIAL REVIEW;6
	295	+	SECTION 8. In Colorado Revised Statutes, amend 10-16-14167
	296	+	as follows:8
	297	+	10-16-1416. Repeal of part. This part 14 is repealed, effective9
	298	+	September 1, 2026 SEPTEMBER 1, 2031. Before the repeal, the functions10
	299	+	of the board are scheduled for review in accordance with section11
	300	+	24-34-104.12
	301	+	SECTION 9. In Colorado Revised Statutes, 24-34-104, repeal13
	302	+	(27)(a)(XIX); and add (32)(a)(X) as follows:14
	303	+	24-34-104. General assembly review of regulatory agencies15
	304	+	and functions for repeal, continuation, or reestablishment - legislative16
	305	+	declaration - repeal. (27) (a) The following agencies, functions, or both,17
	306	+	are scheduled for repeal on September 1, 2026:18
	307	+	(XIX) The Colorado prescription drug affordability review board19
	308	+	created in section 10-16-1402.20
	309	+	(32) (a) The following agencies, functions, or both, are scheduled21
	310	+	for repeal on September 1, 2031:22
265	311		(X) T
266		-	HE COLORADO PRESCRIPTION DRUG AFFORDABILITY REVIEW
267		-	BOARD CREATED IN SECTION
268		-	10-16-1402.
269		-	SECTION 10. In Colorado Revised Statutes, 10-16-113.5, amend
270		-	(2)(a)(III) and (2)(a)(IV); and add (2)(a)(V) as follows:
271		-	PAGE 7-HOUSE BILL 23-1225 10-16-113.5. Independent external review of adverse
272		-	determinations - legislative declaration - definitions - rules. (2) As used
273		-	in this section, unless the context otherwise requires:
274		-	(a) "Adverse determination" means a denial of:
275		-	(III) A request for benefits on the grounds that the treatment or
276		-	services are experimental or investigational; or
277		-	(IV) A benefit as described in section 10-16-113 (1)(c); OR
278		-	(V) A REQUEST FOR BENEFITS FOR A PRESCRIPTION DRUG THAT IS
279		-	UNAVAILABLE IN THE STATE BECAUSE A MANUFACTURER HAS WITHDRAWN
280		-	THE PRESCRIPTION DRUG FROM SALE OR DISTRIBUTION WITHIN THE STATE
281		-	UNDER SECTION
282		-	10-16-1412.
283		-	SECTION 11. Act subject to petition - effective date. Section 4
284		-	of this act takes effect January 1, 2025, and the remainder of this act takes
285		-	effect at 12:01 a.m. on the day following the expiration of the ninety-day
286		-	period after final adjournment of the general assembly; except that, if a
287		-	referendum petition is filed pursuant to section 1 (3) of article V of the state
288		-	constitution against this act or an item, section, or part of this act within
289		-	such period, then the act, item, section, or part will not take effect unless
290		-	approved by the people at the general election to be held in November 2024
291		-	PAGE 8-HOUSE BILL 23-1225 and, in such case, will take effect on the date of the official declaration of
292		-	the vote thereon by the governor; except that section 4 of this act takes
293		-	effect January 1, 2026.
294		-	____________________________ ____________________________
295		-	Julie McCluskie Steve Fenberg
296		-	SPEAKER OF THE HOUSE PRESIDENT OF
297		-	OF REPRESENTATIVES THE SENATE
298		-	____________________________ ____________________________
299		-	Robin Jones Cindi L. Markwell
300		-	CHIEF CLERK OF THE HOUSE SECRETARY OF
301		-	OF REPRESENTATIVES THE SENATE
302		-	APPROVED________________________________________
303		-	(Date and Time)
304		-	_________________________________________
305		-	Jared S. Polis
306		-	GOVERNOR OF THE STATE OF COLORADO
307		-	PAGE 9-HOUSE BILL 23-1225
	312	+	HE COLORADO PRESCRIPTION DRUG AFFORDABILITY REVIEW23
	313	+	BOARD CREATED IN SECTION 10-16-1402.24
	314	+	SECTION 10. In Colorado Revised Statutes, 10-16-113.5,25
	315	+	amend (2)(a)(III) and (2)(a)(IV); and add (2)(a)(V) as follows:26
	316	+	10-16-113.5. Independent external review of adverse27
	317	+	1225
	318	+	-9- determinations - legislative declaration - definitions - rules. (2) As1
	319	+	used in this section, unless the context otherwise requires:2
	320	+	(a) "Adverse determination" means a denial of:3
	321	+	(III) A request for benefits on the grounds that the treatment or4
	322	+	services are experimental or investigational; or5
	323	+	(IV) A benefit as described in section 10-16-113 (1)(c);
	324	+	OR6
	325	+	(V) A
	326	+	REQUEST FOR BENEFITS FOR A PRESCRIPTION DRUG THAT IS7
	327	+	UNAVAILABLE IN THE STATE BECAUSE A M ANUFACTURER HAS WITHDRAWN8
	328	+	THE PRESCRIPTION DRUG FROM SALE OR DISTRIBUTION WITHIN THE STATE9
	329	+	UNDER SECTION 10-16-1412.10
	330	+	SECTION 11. Act subject to petition - effective date. Section11
	331	+	4 of this act takes effect January 1, 2025, and the remainder of this act12
	332	+	takes effect at 12:01 a.m. on the day following the expiration of the13
	333	+	ninety-day period after final adjournment of the general assembly; except14
	334	+	that, if a referendum petition is filed pursuant to section 1 (3) of article V15
	335	+	of the state constitution against this act or an item, section, or part of this16
	336	+	act within such period, then the act, item, section, or part will not take17
	337	+	effect unless approved by the people at the general election to be held in18
	338	+	November 2024 and, in such case, will take effect on the date of the19
	339	+	official declaration of the vote thereon by the governor; except that20
	340	+	section 4 of this act takes effect January 1, 2026.21
	341	+	1225
	342	+	-10-