Colorado 2022 Regular Session

Colorado House Bill HB1370 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
	1	+	Second Regular Session
	2	+	Seventy-third General Assembly
	3	+	STATE OF COLORADO
	4	+	REREVISED
	5	+	This Version Includes All Amendments
	6	+	Adopted in the Second House
	7	+	LLS NO. 22-0251.01 Kristen Forrestal x4217
1	8		HOUSE BILL 22-1370
2		-	BY REPRESENTATIVE(S) Jodeh and Sirota, Amabile, Bacon, Bernett,
3		-	Boesenecker, Caraveo, Cutter, Duran, Froelich, Gonzales-Gutierrez, Gray,
4		-	Hooton, Kennedy, Kipp, Lindsay, Michaelson Jenet, Ortiz, Sullivan,
5		-	Weissman, Will, Woodrow, Young, Esgar, Exum, Herod, Lontine,
6		-	McCormick, McLachlan, Ricks, Titone, Valdez D., Garnett, Benavidez,
7		-	Daugherty, Tipper, Valdez A.;
8		-	also SENATOR(S) Winter and Buckner, Jaquez Lewis, Pettersen.
	9	+	House Committees Senate Committees
	10	+	Health & Insurance State, Veterans, & Military Affairs
	11	+	Appropriations Appropriations
	12	+	A BILL FOR AN ACT
9	13		C
10		-	ONCERNING COVERAGE REQUIREMENTS FOR HEALTH -CARE PRODUCTS,
11		-	AND, IN CONNECTION THEREWITH, MAKING AN APPROPRIATION.
12		-
13		-	Be it enacted by the General Assembly of the State of Colorado:
14		-	SECTION 1. In Colorado Revised Statutes, add 10-16-103.6 as
15		-	follows:
16		-	10-16-103.6. Copayment-only prescription payment structures
17		-	- required inclusion in health benefit plans - rules. (1) (a) I
18		-	N ADDITION
19		-	TO THE REQUIREMENTS IN SECTION
20		-	10-16-103.4 (2), FOR HEALTH BENEFIT
21		-	PLANS ISSUED OR RENEWED ON OR AFTER
22		-	JANUARY 1, 2023, EACH CARRIER
23		-	THAT OFFERS AN INDIVIDUAL OR SMALL GROUP HEALTH BENEFIT PLAN SHALL
24		-	OFFER AT LEAST TWENTY
25		-	-FIVE PERCENT OF ITS HEALTH BENEFIT PLANS ON
26		-	NOTE: This bill has been prepared for the signatures of the appropriate legislative
27		-	officers and the Governor. To determine whether the Governor has signed the bill
28		-	or taken other action on it, please consult the legislative status sheet, the legislative
29		-	history, or the Session Laws.
30		-	________
31		-	Capital letters or bold & italic numbers indicate new material added to existing law; dashes
32		-	through words or numbers indicate deletions from existing law and such material is not part of
33		-	the act. THE EXCHANGE AND AT LEAST TWENTY -FIVE PERCENT OF ITS PLANS NOT ON
34		-	THE EXCHANGE IN EACH BRONZE
35		-	, SILVER, GOLD, AND PLATINUM BENEFIT
36		-	LEVEL IN EACH SERVICE AREA AS COPAYMENT
37		-	-ONLY PAYMENT STRUCTURES
38		-	FOR ALL PRESCRIPTION DRUG COST TIERS
39		-	.
	14	+	ONCERNING COVERAGE REQUIREMENTS FOR HEALTH -CARE101
	15	+	PRODUCTS, AND, IN CONNECTION THEREWITH, MAKING AN102
	16	+	APPROPRIATION.103
	17	+	Bill Summary
	18	+	(Note: This summary applies to this bill as introduced and does
	19	+	not reflect any amendments that may be subsequently adopted. If this bill
	20	+	passes third reading in the house of introduction, a bill summary that
	21	+	applies to the reengrossed version of this bill will be available at
	22	+	http://leg.colorado.gov
	23	+	.)
	24	+	Beginning in 2023, the bill requires each health insurance carrier
	25	+	(carrier) that offers an individual or small group health benefit plan in this
	26	+	state to offer at least 25% of its health benefit plans on the Colorado
	27	+	health benefit exchange (exchange) and at least 25% of its plans not on
	28	+	the exchange in each bronze, silver, gold, and platinum benefit level in
	29	+	SENATE
	30	+	3rd Reading Unamended
	31	+	May 9, 2022
	32	+	SENATE
	33	+	Amended 2nd Reading
	34	+	May 6, 2022
	35	+	HOUSE
	36	+	3rd Reading Unamended
	37	+	May 2, 2022
	38	+	HOUSE
	39	+	Amended 2nd Reading
	40	+	April 29, 2022
	41	+	HOUSE SPONSORSHIP
	42	+	Jodeh and Sirota, Amabile, Bacon, Bernett, Boesenecker, Caraveo, Cutter, Duran,
	43	+	Froelich, Gonzales-Gutierrez, Gray, Hooton, Kennedy, Kipp, Lindsay, Michaelson Jenet,
	44	+	Ortiz, Sullivan, Weissman, Will, Woodrow, Young, Esgar, Exum, Garnett, Herod, Lontine,
	45	+	McCormick, McLachlan, Ricks, Titone, Valdez D.
	46	+	SENATE SPONSORSHIP
	47	+	Winter and Buckner, Jaquez Lewis, Pettersen
	48	+	Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment.
	49	+	Capital letters or bold & italic numbers indicate new material to be added to existing statute.
	50	+	Dashes through the words indicate deletions from existing statute. each service area as copayment-only payment structures for all
	51	+	prescription drug cost tiers.
	52	+	Starting in 2024, a carrier or, if a carrier uses a pharmacy benefit
	53	+	manager (PBM) for claims processing services or other prescription drug
	54	+	or device services under a health benefit plan offered by the carrier, the
	55	+	PBM, or a representative of the carrier or the PBM, is prohibited from
	56	+	modifying or applying a modification to the current prescription drug
	57	+	formulary during the current plan year.
	58	+	The bill repeals and reenacts the current requirements for step
	59	+	therapy and requires a carrier to use clinical review criteria to establish
	60	+	the step-therapy protocol.
	61	+	For each health benefit plan issued or renewed on or after January
	62	+	1, 2024, the bill requires each carrier or PBM to demonstrate to the
	63	+	division of insurance that:
	64	+	! 100% of the estimated rebates received or to be received in
	65	+	connection with dispensing or administering prescription
	66	+	drugs included in the carrier's prescription drug formulary
	67	+	are used to reduce costs for the employer or individual
	68	+	purchasing the plan;
	69	+	! For small group and large employer health benefit plans, all
	70	+	rebates are used to reduce employer and individual
	71	+	employee costs; and
	72	+	! For individual health benefit plans, all rebates are used to
	73	+	reduce consumers' premiums and out-of-pocket costs for
	74	+	prescription drugs to the extent practicable.
	75	+	The bill requires the commissioner of insurance (commissioner)
	76	+	to promulgate rules to implement prescription drug pass-through
	77	+	requirements for carriers. Each carrier or PBM is required to report
	78	+	annually specified prescription drug rebate information to the
	79	+	commissioner.
	80	+	Beginning in 2023, the bill requires the department of health care
	81	+	policy and financing, in collaboration with the administrator of the
	82	+	all-payer claims database, to conduct an annual analysis of the
	83	+	prescription drug rebates received in the previous calendar year, by carrier
	84	+	and prescription drug tier, and make the analysis available to the public.
	85	+	Be it enacted by the General Assembly of the State of Colorado:1
	86	+	SECTION 1. In Colorado Revised Statutes, add 10-16-103.6 as2
	87	+	follows:3
	88	+	10-16-103.6. Copayment-only prescription payment structures4
	89	+	- required inclusion in health benefit plans - rules. (1) (a) (I) I
	90	+	N5
	91	+	1370-2- ADDITION TO THE REQUIREMENTS IN SECTION 10-16-103.4 (2), FOR HEALTH1
	92	+	BENEFIT PLANS ISSUED OR RENEWED ON OR AFTER JANUARY 1, 2023, EACH2
	93	+	CARRIER THAT OFFERS AN INDIVIDUAL OR SMALL GROUP HEALTH BENEFIT3
	94	+	PLAN SHALL OFFER AT LEAST TWENTY -FIVE PERCENT OF ITS HEALTH4
	95	+	BENEFIT PLANS ON THE EXCHANGE AND AT LEAST TWENTY -FIVE PERCENT5
	96	+	OF ITS PLANS NOT ON THE EXCHANGE IN EACH BRONZE , SILVER, GOLD, AND6
	97	+	PLATINUM BENEFIT LEVEL IN EACH SERVICE AREA AS COPAYMENT -ONLY7
	98	+	PAYMENT STRUCTURES FOR ALL PRESCRIPTION DRUG COST TIERS .8
40	99		(b) F
41		-	OR EACH COPAYMENT -ONLY PAYMENT STRUCTURE FOR
42		-	PRESCRIPTIONS DRUGS
43		-	:
	100	+	OR EACH COPAYMENT -ONLY PAYMENT STRUCTURE FOR9
	101	+	PRESCRIPTIONS DRUGS:10
44	102		(I) T
45		-	HE COPAYMENT AMOUNT FOR THE HIGHEST PRESCRIPTION DRUG
46		-	COST TIER MUST NOT BE GREATER THAN ONE
47		-	-TWELFTH OF THE HEALTH
48		-	BENEFIT PLAN
49		-	'S OUT-OF-POCKET MAXIMUM AMOUNT ;
	103	+	HE COPAYMENT AMOUNT FOR THE HIGHEST PRESCRIPTION11
	104	+	DRUG COST TIER MUST NOT BE GREATER THAN ONE -TWELFTH OF THE12
	105	+	HEALTH BENEFIT PLAN'S OUT-OF-POCKET MAXIMUM AMOUNT ;13
50	106		(II) T
51		-	HE COPAYMENT AMOUNTS BETWEEN THE TWO HIGHEST
52		-	PRESCRIPTION DRUG COST TIERS MUST HAVE A COST DIFFERENCE OF AT
53		-	LEAST TEN PERCENT
54		-	;
	107	+	HE COPAYMENT AMOUNTS BETWEEN THE TWO HIGHEST14
	108	+	PRESCRIPTION DRUG COST TIERS MUST HAVE A COST DIFFERENCE OF AT15
	109	+	LEAST TEN PERCENT;16
55	110		(III) N
56		-	O MORE THAN FIFTY PERCENT OF THE DRUGS ON THE
57		-	PRESCRIPTION DRUG FORMULARY USED TO TREAT A SPECIFIC CONDITION MAY
58		-	BE PLACED ON THE HIGHEST PRESCRIPTION DRUG COST TIER
59		-	; AND
60		-	(IV) EACH CARRIER SHALL USE "RX COPAY" AT THE END OF THE
61		-	MARKETING NAMES FOR EACH COPAYMENT
62		-	-ONLY PAYMENT STRUCTURE .
	111	+	O MORE THAN FIFTY PERCENT OF THE DRUGS ON THE17
	112	+	PRESCRIPTION DRUG FORMULARY USED TO TREAT A SPECIFIC CONDITION18
	113	+	MAY BE PLACED ON THE HIGHEST PRESCRIPTION DRUG COST TIER ; AND19
	114	+	(IV) E
	115	+	ACH CARRIER SHALL USE "RX COPAY" AT THE END OF THE20
	116	+	MARKETING NAMES FOR EACH COPAYMENT -ONLY PAYMENT STRUCTURE .21
63	117		(2) T
64		-	HE COMMISSIONER MAY PROMULGATE RULES TO IMPLEMENT
65		-	AND ENFORCE THIS SECTION
66		-	.
67		-	SECTION 2. In Colorado Revised Statutes, add 10-16-122.4 as
68		-	follows:
69		-	10-16-122.4. Pharmacy benefits - formulary change prohibition
70		-	- exceptions - definition - rules. (1) (a) S
71		-	TARTING IN 2024, EXCEPT AS
72		-	PROVIDED IN SUBSECTION
73		-	(2) OF THIS SECTION, A CARRIER OR, IF A CARRIER
74		-	USES A
75		-	PBM FOR CLAIMS PROCESSING SERVICES OR OTHER PRESCRIPTION
76		-	DRUG OR DEVICE SERVICES
77		-	, AS THOSE TERMS ARE DEFINED IN SECTION
78		-	10-16-122.1, UNDER A HEALTH BENEFIT PLAN OFFERED BY THE CARRIER IN
79		-	THE INDIVIDUAL MARKET
80		-	, THE PBM, OR A REPRESENTATIVE OF THE CARRIER
81		-	OR THE
82		-	PBM, SHALL NOT MODIFY OR APPLY A MODIFICATION TO THE
83		-	CURRENT PRESCRIPTION DRUG FORMULARY DURING THE CURRENT PLAN
84		-	YEAR
85		-	.
86		-	PAGE 2-HOUSE BILL 22-1370 (b) AS USED IN THIS SUBSECTION (1), "MODIFY" OR "MODIFICATION"
87		-	INCLUDES ELIMINATING A PARTICULAR PRESCRIPTION DRUG FROM THE
88		-	FORMULARY OR MOVING A PRESCRIPTION DRUG TO A HIGHER COST
89		-	-SHARING
90		-	TIER
91		-	.
	118	+	HE COMMISSIONER MAY PROMULGATE RULES TO IMPLEMENT22
	119	+	AND ENFORCE THIS SECTION.23
	120	+	SECTION 2. In Colorado Revised Statutes, add 10-16-122.4 as24
	121	+	follows:25
	122	+	10-16-122.4. Pharmacy benefits - formulary change26
	123	+	prohibition - exceptions - definition - rules. (1) (a) S
	124	+	TARTING IN 2024,27
	125	+	1370
	126	+	-3- EXCEPT AS PROVIDED IN SUBSECTION (2) OF THIS SECTION, A CARRIER OR,1
	127	+	IF A CARRIER USES A PBM FOR CLAIMS PROCESSING SERVICES OR OTHER2
	128	+	PRESCRIPTION DRUG OR DEVICE SERVICES, AS THOSE TERMS ARE DEFINED3
	129	+	IN SECTION 10-16-122.1, UNDER A HEALTH BENEFIT PLAN OFFERED BY THE4
	130	+	CARRIER IN THE INDIVIDUAL MARKET, THE PBM, OR A REPRESENTATIVE5
	131	+	OF THE CARRIER OR THE PBM, SHALL NOT MODIFY OR APPLY A6
	132	+	MODIFICATION TO THE CURRENT PRESCRIPTION DRUG FORMULARY DURING7
	133	+	THE CURRENT PLAN YEAR.8
	134	+	(b) A
	135	+	S USED IN THIS SUBSECTION (1), "MODIFY" OR9
	136	+	"
	137	+	MODIFICATION" INCLUDES ELIMINATING A PARTICULAR PRESCRIPTION10
	138	+	DRUG FROM THE FORMULARY OR M OVING A PRESCRIPTION DRUG TO A11
	139	+	HIGHER COST-SHARING TIER.12
92	140		(2) A
93		-	CARRIER OFFERING A HEALTH BENEFIT PLAN ~~ON THE~~
94		-	~~INDIVIDUAL MARKET IN THIS STATE THAT INCLUDES A PRESCRIPTION DRUG~~
95		-	~~BENEFIT AND USES~~ A PRESCRIPTION ~~DRUG FORMULARY OR LIST OF COVERED~~
96		-	~~DRUGS MAY~~
97		-	:
	141	+	CARRIER OFFERING A HEALTH BENEFIT PLAN
	142	+	ON THE13
	143	+	INDIVIDUAL MARKET IN THIS STATE THAT INCLUDES A PRESCRIPTION DRUG14
	144	+	BENEFIT AND USES A PRESCRIPTION DRUG FORMULARY OR LIST OF15
	145	+	COVERED DRUGS MAY:16
98	146		(a) R
99		-	EMOVE A PRESCRIPTION DRUG FROM THE PRESCRIPTION DRUG
100		-	FORMULARY OR LIST OF COVERED DRUGS
101		-	, WITH NOTICE TO A COVERED
102		-	PERSON AND THE COVERED PERSON
103		-	'S PROVIDER, IF:
	147	+	EMOVE A PRESCRIPTION DRUG FROM THE PRESCRIPTION DRUG17
	148	+	FORMULARY OR LIST OF COVERED DRUGS , WITH
	149	+	NOTICE TO A COVERED18
	150	+	PERSON AND THE COVERED PERSON 'S PROVIDER, IF:19
104	151		(I) T
105		-	HE FDA ISSUES AN ANNOUNCEMENT , GUIDANCE, NOTICE,
106		-	WARNING, OR STATEMENT CONCERNING THE PRESCRIPTION DRUG THAT
107		-	CALLS INTO QUESTION THE CLINICAL SAFETY OF THE PRESCRIPTION DRUG
108		-	; OR
109		-	(II) THE PRESCRIPTION DRUG IS APPROVED BY THE FDA FOR USE
110		-	WITHOUT A PRESCRIPTION
111		-	;
	152	+	HE FDA ISSUES AN ANNOUNCEMENT , GUIDANCE, NOTICE,20
	153	+	WARNING, OR STATEMENT CONCERNING THE PRESCRIPTION DRUG THAT21
	154	+	CALLS INTO QUESTION THE CLINICAL SAFETY OF THE PRESCRIPTION DRUG ;22
	155	+	OR23
	156	+	(II) T
	157	+	HE PRESCRIPTION DRUG IS APPROVED BY THE FDA FOR USE24
	158	+	WITHOUT A PRESCRIPTION;
	159	+	25
112	160		(b) M
113		-	OVE A ~~PRESCRIPTION DRUG FROM A PRESCRIPTION DRUG~~
114		-	~~COST~~
115		-	-SHARING TIER THAT IMPOSES A LESSER COPAYMENT OR ~~DEDUCTIBLE~~
116		-	~~FOR THE PRESCRIPTION DRUG TO A COST~~
117		-	-SHARING TIER THAT ~~IMPOSES A~~
118		-	GREATER COPAYMENT OR DEDUCTIBLE FOR THE PRESCRIPTION ~~DRUG IF THE~~
119		-	CARRIER ADDS TO THE PRESCRIPTION DRUG FORMULARY OR LIST ~~OF COVERED~~
120		-	DRUGS A GENERIC PRESCRIPTION DRUG OR BIOSIMILAR ~~DRUG THAT IS~~
121		-	:
	161	+	OVE A
	162	+	PRESCRIPTION DRUG FROM A PRESCRIPTION DRUG26
	163	+	COST-SHARING TIER THAT IMPOSES A LESSER COPAYMENT OR DEDUCTIBLE27
	164	+	1370
	165	+	-4- FOR THE PRESCRIPTION DRUG TO A COST-SHARING TIER THAT IMPOSES1
	166	+	A GREATER COPAYMENT OR DEDUCTIBLE FOR THE PRESCRIPTION DRUG2
	167	+	IF THE CARRIER ADDS TO THE PRESCRIPTION DRUG FORMULARY OR LIST OF3
	168	+	COVERED DRUGS A GENERIC PRESCRIPTION DRUG OR BIOSIMILAR DRUG4
	169	+	THAT IS:5
122	170		(I) A
123		-	PPROVED BY THE FDA FOR USE AS A THERAPEUTIC EQUIVALENT;
124		-	AND
125		-	(II) IN A PRESCRIPTION DRUG COST-SHARING TIER THAT IMPOSES A
126		-	COPAYMENT OR DEDUCTIBLE FOR THE GENERIC PRESCRIPTION DRUG OR
127		-	BIOSIMILAR DRUG THAT IS LESS THAN THE COPAYMENT OR DEDUCTIBLE THAT
128		-	IS IMPOSED FOR THE BRAND
129		-	-NAME PRESCRIPTION DRUG IN THE
130		-	COST
131		-	-SHARING TIER TO WHICH THE BRAND -NAME PRESCRIPTION DRUG IS
132		-	MOVED
133		-	;
134		-	(c) R
135		-	EMOVE A PRESCRIPTION DRUG FROM THE PRESCRIPTION DRUG
136		-	FORMULARY OR LIST OF COVERED DRUGS
137		-	, OR MOVE A PRESCRIPTION DRUG
138		-	PAGE 3-HOUSE BILL 22-1370 TO A HIGHER COST SHARING TIER, WITH ADVANCE NOTICE TO A COVERED
139		-	PERSON AND THE COVERED PERSON
140		-	'S PROVIDER, IF:
	171	+	PPROVED BY THE FDA FOR USE AS
	172	+	A THERAPEUTIC6
	173	+	EQUIVALENT; AND7
	174	+	(II) I
	175	+	N A PRESCRIPTION DRUG COST-SHARING TIER THAT IMPOSES8
	176	+	A COPAYMENT OR DEDUCTIBLE FOR THE GENERIC PRESCRIPTION DRUG
	177	+	OR9
	178	+	BIOSIMILAR DRUG THAT IS LESS THAN THE COPAYMENT OR DEDUCTIBLE10
	179	+	THAT IS IMPOSED FOR THE BRAND -NAME PRESCRIPTION DRUG IN THE11
	180	+	COST-SHARING TIER TO WHICH THE BRAND -NAME PRESCRIPTION DRUG IS12
	181	+	MOVED; OR13
	182	+	(c) REMOVE A PRESCRIPTION DRUG FROM THE PRESCRIPTION DRUG14
	183	+	FORMULARY OR LIST OF COVERED DRUGS, OR MOVE A PRESCRIPTION DRUG15
	184	+	TO A HIGHER COST SHARING TIER, WITH ADVANCE NOTICE TO A COVERED16
	185	+	PERSON AND THE COVERED PERSON 'S PROVIDER, IF:17
	186	+	(I) THE PRESCRIPTION DRUG HAS A WHOLESALE ACQUISITION COST18
	187	+	GREATER THAN FIVE HUNDRED DOLLARS AT THE START OF THE BENEFIT19
	188	+	YEAR AND THE CARRIER'S NET COST INCREASES BY FIFTEEN PERCENT OR20
	189	+	MORE DURING THAT BENEFIT YEAR ; AND21
	190	+	(II) THE PRESCRIPTION DRUG WILL BE REPLACED ON THE22
	191	+	FORMULARY WITH A THERAPEUTICALLY EQUIVALENT GENERIC OR23
	192	+	MULTI-SOURCE BRAND NAME DRUG, AN INTERCHANGEABLE BIOLOGIC, OR24
	193	+	BIOSIMILAR DRUG AT A LOWER COST TO THE ENROLLEE .25
	194	+	(d) PRIOR TO REMOVING A DRUG FROM A FORMULARY PURSUANT26
	195	+	TO THIS SECTION, THE CARRIER MUST ATTEST AND DEMONSTRATE TO THE27
	196	+	1370
	197	+	-5- DIVISION, IN A FORM AND MANNER DETERMINED BY THE COMMISSIONER BY1
	198	+	RULE, THAT IT HAS COMPLIED WITH THE REQUIREMENTS OF THIS SECTION2
	199	+	AND HAS PROVIDED ADVANCED NOTICE TO ITS ENROLLEES .3
	200	+	(3) T
	201	+	HIS SECTION DOES NOT PROHIBIT A CARRIER FROM ADDING A4
	202	+	PRESCRIPTION DRUG TO A PRESCRIPTION DRUG FORMULARY OR LIST OF5
	203	+	COVERED DRUGS AT ANY TIME .6
	204	+	(4) T
	205	+	HE COMMISSIONER MAY PROMULGATE RULES TO IMPLEMENT7
	206	+	AND ENFORCE THIS SECTION.8
	207	+	SECTION 3. In Colorado Revised Statutes, repeal and reenact,9
	208	+	with amendments, 10-16-145 as follows:10
	209	+	10-16-145. Step-therapy protocol - limitations - exceptions -11
	210	+	definitions - rules. (1) A
	211	+	S USED IN THIS SECTION:12
	212	+	(a) "BIOSIMILAR" HAS THE MEANING SET FORTH IN 42 U.S.C. SEC.13
	213	+	262 (i)(2).14
	214	+	(b) "C
	215	+	LINICAL PRACTICE GUIDELINES" MEANS A SYSTEMATICALLY15
	216	+	DEVELOPED STATEMENT TO ASSIST PROVIDERS AND COVERED PERSONS IN16
	217	+	MAKING DECISIONS ABOUT APPROPRIATE HEALTH CARE FOR SPECIFIC17
	218	+	CLINICAL CIRCUMSTANCES AND CONDITIONS .18
	219	+	(c) "C
	220	+	LINICAL REVIEW CRITERIA" MEANS THE WRITTEN SCREENING19
	221	+	PROCEDURES, DECISION ABSTRACTS, CLINICAL PROTOCOLS, AND CLINICAL20
	222	+	PRACTICE GUIDELINES USED BY A CARRIER OR PRIVATE UTILIZATION21
	223	+	REVIEW ORGANIZATION TO DETERMINE THE MEDICAL NECESSITY AND22
	224	+	APPROPRIATENESS OF THE PROVISION OF HEALTH -CARE SERVICES.23
	225	+	C
	226	+	LINICAL REVIEW CRITERIA MUST NOT BE MORE RESTRICTIVE THAN THE24
	227	+	FDA'
	228	+	S INDICATION FOR A SPECIFIC DRUG OR HEALTH- CARE SERVICE.25
	229	+	(d) "EXIGENT CIRCUMSTANCE" MEANS A CIRCUMSTANCE IN WHICH26
	230	+	A COVERED PERSON IS SUFFERING FROM A HEALTH CONDITION THAT MAY27
	231	+	1370
	232	+	-6- SERIOUSLY JEOPARDIZE THE COVERED PERSON'S LIFE, HEALTH, OR ABILITY1
	233	+	TO REGAIN MAXIMUM FUNCTIONS .2
	234	+	(e) "MEDICAL NECESSITY" HAS THE SAME MEANING AS SET FORTH3
	235	+	IN SECTION 10-16-112.5.4
	236	+	(f) "P
	237	+	RIVATE UTILIZATION REVIEW ORGANIZATION " OR5
	238	+	"
	239	+	ORGANIZATION" HAS THE SAME MEANING AS SET FORTH IN SECTION6
	240	+	10-16-112 (1)(a).7
	241	+	(g) "STEP THERAPY" MEANS A PROTOCOL THAT REQUIRES A8
	242	+	COVERED PERSON TO USE A PRESCRIPTION DRUG OR SEQUENCE OF9
	243	+	PRESCRIPTION DRUGS, OTHER THAN THE DRUG THAT THE COVERED10
	244	+	PERSON'S HEALTH-CARE PROVIDER RECOMMENDS FOR THE COVERED11
	245	+	PERSON'S TREATMENT, BEFORE THE CARRIER PROVIDES COVERAGE FOR12
	246	+	THE RECOMMENDED PRESCRIPTION DRUG .13
	247	+	(2) I
	248	+	F A CARRIER, A PRIVATE UTILIZATION REVIEW ORGANIZATION ,14
	249	+	OR A PBM REQUIRES
	250	+	STEP THERAPY, THE CARRIER, ORGANIZATION, OR15
	251	+	PBM
	252	+	SHALL USE CLINICAL REVIEW CRITERIA TO ESTABLISH THE PROTOCOL16FOR STEP THERAPY BASED ON CLINICAL PRACTICE GUIDELINES .17
	253	+	(3) A CARRIER, PRIVATE UTILIZATION REVIEW ORGANIZATION, OR18
	254	+	PBM SHALL:19
	255	+	(a) MAKE THE CLINICAL REVIEW CRITERIA AND THE STEP THERAPY20
	256	+	EXEMPTION PROCESS AVAILABLE ON THEIR WEBSITES ; AND21
	257	+	(b) UPON WRITTEN REQUEST, PROVIDE ALL SPECIFIC CLINICAL22
	258	+	REVIEW CRITERIA AND OTHER CLINICAL INFORMATION RELATING TO A23
	259	+	COVERED PERSON'S PARTICULAR CONDITION OR DISEASE , INCLUDING24
	260	+	CLINICAL REVIEW CRITERIA RELATING TO A STEP-THERAPY EXCEPTION, TO25
	261	+	THE REQUESTER.26
	262	+	27
	263	+	1370
	264	+	-7- (4) (a) A CARRIER, A PRIVATE UTILIZATION REVIEW1
	265	+	ORGANIZATION, OR A PBM SHALL GRANT AN EXCEPTION TO STEP2
	266	+	THERAPY IF THE PRESCRIBING PROVIDER SUBMITS JUSTIFICATION AND3
	267	+	SUPPORTING CLINICAL DOCUMENTATION , IF NEEDED, THAT STATES:4
141	268		(I) T
142		-	HE PRESCRIPTION DRUG HAS A WHOLESALE ACQUISITION COST
143		-	GREATER THAN FIVE HUNDRED DOLLARS AT THE START OF THE BENEFIT YEAR
144		-	AND THE CARRIER
145		-	'S NET COST INCREASES BY FIFTEEN PERCENT OR MORE
146		-	DURING THAT BENEFIT YEAR
147		-	; AND
148		-	(II) THE PRESCRIPTION DRUG WILL BE REPLACED ON THE FORMULARY
149		-	WITH A THERAPEUTICALLY EQUIVALENT GENERIC OR MULTI
150		-	-SOURCE BRAND
151		-	NAME DRUG
152		-	, AN INTERCHANGEABLE BIOLOGIC , OR BIOSIMILAR DRUG AT A
153		-	LOWER COST TO THE ENROLLEE
154		-	; OR
155		-	(d) PRIOR TO REMOVING A DRUG FROM A FORMULARY PURSUANT TO
156		-	THIS SECTION
157		-	, THE CARRIER MUST ATTEST AND DEMONSTRATE TO THE
158		-	DIVISION
159		-	, IN A FORM AND MANNER DETERMINED BY THE COMMISSIONER BY
160		-	RULE
161		-	, THAT IT HAS COMPLIED WITH THE REQUIREMENTS OF THIS SECTION
162		-	AND HAS PROVIDED ADVANCED NOTICE TO ITS ENROLLEES
163		-	.
164		-	(3) T
165		-	HIS SECTION DOES NOT PROHIBIT A CARRIER FROM ADDING A
166		-	PRESCRIPTION DRUG TO A PRESCRIPTION DRUG FORMULARY OR LIST OF
167		-	COVERED DRUGS AT ANY TIME
168		-	.
169		-	(4) T
170		-	HE COMMISSIONER MAY PROMULGATE RULES TO IMPLEMENT
171		-	AND ENFORCE THIS SECTION
172		-	.
173		-	SECTION 3. In Colorado Revised Statutes, repeal and reenact,
174		-	with amendments, 10-16-145 as follows:
175		-	10-16-145. Step-therapy protocol - limitations - exceptions -
176		-	definitions - rules. (1) A
177		-	S USED IN THIS SECTION:
178		-	(a) "B
179		-	IOSIMILAR" HAS THE MEANING SET FORTH IN 42 U.S.C. SEC.
180		-	262 (i)(2).
181		-	(b) "C
182		-	LINICAL PRACTICE GUIDELINES" MEANS A SYSTEMATICALLY
183		-	DEVELOPED STATEMENT TO ASSIST PROVIDERS AND COVERED PERSONS IN
184		-	MAKING DECISIONS ABOUT APPROPRIATE HEALTH CARE FOR SPECIFIC
185		-	CLINICAL CIRCUMSTANCES AND CONDITIONS
186		-	.
187		-	PAGE 4-HOUSE BILL 22-1370 (c) "CLINICAL REVIEW CRITERIA" MEANS THE WRITTEN SCREENING
188		-	PROCEDURES
189		-	, DECISION ABSTRACTS, CLINICAL PROTOCOLS, AND CLINICAL
190		-	PRACTICE GUIDELINES USED BY A CARRIER OR PRIVATE UTILIZATION REVIEW
191		-	ORGANIZATION TO D ETERMINE THE MEDICAL NECESSITY AND
192		-	APPROPRIATENESS OF THE PROVISION OF HEALTH
193		-	-CARE SERVICES. CLINICAL
194		-	REVIEW CRITERIA MUST NOT BE MORE RESTRICTIVE THAN THE
195		-	FDA'S
196		-	INDICATION FOR A SPECIFIC DRUG OR HEALTH
197		-	-CARE SERVICE.
198		-	(d) "E
199		-	XIGENT CIRCUMSTANCE" MEANS A CIRCUMSTANCE IN WHICH
200		-	A COVERED PERSON IS SUFFERING FROM A HEALTH CONDITION THAT MAY
201		-	SERIOUSLY JEOPARDIZE THE COVERED PERSON
202		-	'S LIFE, HEALTH, OR ABILITY
203		-	TO REGAIN MAXIMUM FUNCTIONS
204		-	.
205		-	(e) "M
206		-	EDICAL NECESSITY" HAS THE SAME MEANING AS SET FORTH IN
207		-	SECTION
208		-	10-16-112.5.
209		-	(f) "P
210		-	RIVATE UTILIZATION REVIEW ORGANIZATION " OR
211		-	"ORGANIZATION" HAS THE SAME MEANING AS SET FORTH IN SECTION
212		-	10-16-112 (1)(a).
213		-	(g) "S
214		-	TEP THERAPY" MEANS A PROTOCOL THAT REQUIRES A COVERED
215		-	PERSON TO USE A PRESCRIPTION DRUG OR SEQUENCE OF PRESCRIPTION
216		-	DRUGS
217		-	, OTHER THAN THE DRUG THAT THE COVERED PERSON 'S HEALTH-CARE
218		-	PROVIDER RECOMMENDS FOR THE COVERED PERSON
219		-	'S TREATMENT, BEFORE
220		-	THE CARRIER PROVIDES COVERAGE FOR THE RECOMMENDED PRESCRIPTION
221		-	DRUG
222		-	.
223		-	(2) I
224		-	F A CARRIER, A PRIVATE UTILIZATION REVIEW ORGANIZATION, OR
225		-	A
226		-	PBM REQUIRES STEP THERAPY, THE CARRIER, ORGANIZATION, OR PBM
227		-	SHALL USE CLINICAL REVIEW CRITERIA TO ESTABLISH THE PROTOCOL FOR
228		-	STEP THERAPY BASED ON CLINICAL PRACTICE GUIDELINES
229		-	.
	269	+	HE PROVIDER ATTESTS THAT THE
	270	+	REQUIRED PRESCRIPTION5
	271	+	DRUG IS CONTRAINDICATED OR WILL LIKELY CAUSE AN ADVERSE REACTION6
	272	+	OR HARM TO THE COVERED PERSON ;7
	273	+	(II) T
	274	+	HE REQUIRED PRESCRIPTION DRUG IS
	275	+	INEFFECTIVE BASED8
	276	+	ON THE KNOWN CLINICAL CHARACTERISTICS OF THE COVERED PERSON AND9
	277	+	THE KNOWN CHARACTERISTICS OF THE PRESCRIPTION DRUG REGIMEN ;10
	278	+	(III) T
	279	+	HE COVERED PERSON HAS TRIED , WHILE UNDER THE11
	280	+	COVERED PERSON'S CURRENT OR PREVIOUS HEALTH BENEFIT PLAN , THE12
	281	+	REQUIRED PRESCRIPTION DRUG OR ANOTHER PRESCRIPTION DRUG IN THE13
	282	+	SAME PHARMACOLOGIC CLASS OR WITH THE SAME MECHANISM OF ACTION ,14
	283	+	AND THE USE OF THE PRESCRIPTION DRUG BY THE COVERED PERSON WAS15
	284	+	DISCONTINUED DUE TO LACK OF EFFICACY OR EFFECTIVENESS , DIMINISHED16
	285	+	EFFECT, OR AN ADVERSE EVENT;17 18
	286	+	(IV) THE COVERED PERSON, WHILE ON THE COVERED PERSON 'S19
	287	+	CURRENT OR PREVIOUS HEALTH BENEFIT PLAN , IS STABLE ON A20
	288	+	PRESCRIPTION DRUG SELECTED BY THE PRESCRIBING PROVIDER FOR THE21
	289	+	MEDICAL CONDITION UNDER CONSIDERATION AFTER UNDERGOING STEP22
	290	+	THERAPY OR AFTER HAVING SOUGHT AND RECEIVED A STEP-THERAPY23
	291	+	EXCEPTION.24
	292	+	(b) (I) EXCEPT AS PROVIDED IN SUBSECTION (4)(b)(II) OF THIS25
	293	+	SECTION, A CARRIER, ORGANIZATION, OR PBM SHALL GRANT OR DENY A26
	294	+	STEP THERAPY EXCEPTION REQUEST OR AN APPEAL OF A DENIAL OF A27
	295	+	1370
	296	+	-8- REQUEST WITHIN:1
	297	+	(A) THREE BUSINESS DAYS AFTER RECEIPT OF THE REQUEST ; OR2
	298	+	(B) IN CASES WHERE EXIGENT CIRCUMSTANCES EXIST , WITHIN3
	299	+	TWENTY-FOUR HOURS AFTER RECEIPT OF THE REQUEST .4
	300	+	(II) IF A REQUEST FOR A STEP THERAPY EXCEPTION OR AN APPEAL5
	301	+	OF A DENIAL OF A REQUEST IS INCOMPLETE OR IF ADDITIONAL CLINICALLY6
	302	+	RELEVANT INFORMATION IS REQUIRED, THE CARRIER, ORGANIZATION, OR7
	303	+	PBM SHALL NOTIFY THE PRESCRIBING PROVIDER WITHIN SEVENTY-TWO8
	304	+	HOURS AFTER SUBMISSION OF THE REQUEST, OR WITHIN TWENTY-FOUR9
	305	+	HOURS AFTER THE SUBMISSION OF THE REQUEST IF EXIGENT10
	306	+	CIRCUMSTANCES EXIST, THAT THE REQUEST OR APPEAL IS INCOMPLETE OR11
	307	+	THAT ADDITIONAL CLINICALLY RELE VANT INFORMATION IS REQUIRED. THE12
	308	+	CARRIER, ORGANIZATION, OR PBM MUST SPECIFY THE ADDITIONAL13
	309	+	INFORMATION THAT IS REQUIRED IN ORDER TO CONSIDER THE STEP14
	310	+	THERAPY EXCEPTION REQUEST OR THE APPEAL OF THE DENIAL OF THE15
	311	+	REQUEST PURSUANT TO THE CRITERIA DESCRIBED IN SUBSECTION (4)(a) OF16
	312	+	THIS SECTION. ONCE THE REQUESTED INFORMATION IS SUBMITTED TO THE17
	313	+	CARRIER, ORGANIZATION, OR PBM, THE APPLICABLE PERIOD TO GRANT OR18
	314	+	DENY A STEP THERAPY EXCEPTION REQUEST OR AN APPEAL OF A DENIAL OF19
	315	+	A REQUEST, AS SPECIFIED IN SUBSECTION (4)(b)(I) OF THIS SECTION,20
	316	+	APPLIES.21
	317	+	(III) IF A CARRIER, ORGANIZATION, OR PBM DOES NOT MAKE A22
	318	+	DETERMINATION REGARDING THE STEP THERAPY EXCEPTION REQUEST OR23
	319	+	THE APPEAL OF THE DENIAL OF THE REQUEST OR DOES NOT MAKE A24
	320	+	REQUEST FOR ADDITIONAL OR CLINICALLY RELEVANT INFORMATION25
	321	+	WITHIN THE REQUIRED TIME, THE STEP THERAPY EXCEPTION REQUEST OR26
	322	+	THE APPEAL OF THE DENIAL OF THE REQUEST IS DEEMED GRANTED .27
	323	+	1370
	324	+	-9- (c) IF THE INITIAL REQUEST FOR A STEP-THERAPY EXCEPTION IS1
	325	+	DENIED, THE CARRIER, ORGANIZATION, OR PBM SHALL INFORM THE2
	326	+	COVERED PERSON IN WRITING THAT THE COVERED PERSON HAS THE RIGHT3
	327	+	TO AN INTERNAL OR EXTERNAL REVIEW OR AN APPEAL OF THE ADVERSE4
	328	+	DETERMINATION PURSUANT TO SECTIONS 10-16-113 AND 10-16-113.5.5
	329	+	(d) A
	330	+	CARRIER, AN ORGANIZATION, OR A PBM SHALL AUTHORIZE6
	331	+	COVERAGE FOR THE PRESCRIPTION DRUG PRESCRIBED BY THE COVERED7
	332	+	PERSON'S PRESCRIBING PROVIDER WHEN THE STEP-THERAPY
	333	+	EXCEPTION8
	334	+	REQUEST IS GRANTED.9
	335	+	(5) T
	336	+	HIS SECTION DOES NOT PROHIBIT:10
	337	+	(a) A
	338	+	CARRIER, AN ORGANIZATION, OR A PBM FROM REQUIRING A11
	339	+	COVERED PERSON TO TRY A GENERIC EQUIVALENT DRUG , A BIOSIMILAR12
	340	+	DRUG, OR AN INTERCHANGEABLE BIOLOGICAL PRODUCT AS DEFINED BY 4213
	341	+	U.S.C.
	342	+	SEC. 262 (i)(3), UNLESS THE COVERED PERSON OR COVERED14
	343	+	PERSON'S PRESCRIBING PROVIDER HAS REQUESTED A STEP -THERAPY
	344	+	15
	345	+	EXCEPTION AND THE PRESCRIBED DRUG MEETS THE CRITERIA FOR A16
	346	+	STEP-THERAPY EXCEPTION SPECIFIED IN SUBSECTION (4)(a) OF THIS17
	347	+	SECTION;18
	348	+	(b) A
	349	+	CARRIER, AN ORGANIZATION, OR A PBM FROM REQUIRING A19
	350	+	PHARMACIST TO MAKE SUBSTITUTIONS OF PRESCRIPTION DRUGS20
	351	+	CONSISTENT WITH PART 5 OF ARTICLE 280 OF TITLE 12; OR21
	352	+	(c) A
	353	+	PROVIDER FROM PRESCRIBING A DRUG THAT IS DETERMINED22
	354	+	TO BE MEDICALLY APPROPRIATE.23
	355	+	(6) T
	356	+	HE COMMISSIONER MAY PROMULGATE RULES TO IMPLEMENT24
	357	+	AND ENFORCE THIS SECTION.25
	358	+	SECTION 4. In Colorado Revised Statutes, amend as it exists26
	359	+	until January 1, 2023, 10-16-145.5 as follows:27
	360	+	1370
	361	+	-10- 10-16-145.5. Step therapy prohibited - stage four advanced1
	362	+	metastatic cancer - definitions. (1) Notwithstanding section 10-16-145,2
	363	+	a carrier that provides coverage under a health benefit plan for the3
	364	+	treatment of stage four advanced metastatic cancer shall not limit or4
	365	+	exclude coverage under the health benefit plan for a drug approved by the5
	366	+	United States food and drug administration FDA and that is on the6
	367	+	carrier's prescription drug formulary by mandating that a covered person7
	368	+	with stage four advanced metastatic cancer undergo step-therapy STEP8
	369	+	THERAPY if the use of the approved drug is consistent with:9
	370	+	(a) The United States food and drug administration-approved10
	371	+	FDA-
	372	+	APPROVED indication or the National Comprehensive Cancer11
	373	+	Network drugs and biologics compendium indication for the treatment of12
	374	+	stage four advanced metastatic cancer; or13
	375	+	(b) Peer-reviewed medical literature.14
	376	+	(2) For the purposes of
	377	+	AS USED IN this section:15
	378	+	(a) "Stage four advanced metastatic cancer" means cancer that has16
	379	+	spread from the primary or original site of the cancer to nearby tissues,17
	380	+	lymph nodes, or other parts of the body.18
	381	+	(b) "STEP THERAPY" HAS THE SAME MEANING AS SPECIFIED IN19
	382	+	SECTION 10-16-145 (1)(g).20
	383	+	SECTION 5. In Colorado Revised Statutes, amend as it will21
	384	+	become effective January 1, 2023, 10-16-145.5 as follows:22
	385	+	10-16-145.5. Step therapy - prior authorization - prohibited -23
	386	+	stage four advanced metastatic cancer - opioid prescription -24
	387	+	definitions. (1) (a) Notwithstanding section 10-16-145, a carrier that25
	388	+	provides coverage under a health benefit plan for the treatment of stage26
	389	+	four advanced metastatic cancer shall not limit or exclude coverage under27
	390	+	1370
	391	+	-11- the health benefit plan for a drug that is approved by the FDA and that is1
	392	+	on the carrier's prescription drug formulary by mandating that a covered2
	393	+	person with stage four advanced metastatic cancer undergo step-therapy3
	394	+	STEP THERAPY if the use of the approved drug is consistent with:4
	395	+	(I) (a) The FDA-approved indication or the National5
	396	+	Comprehensive Cancer Network drugs and biologics compendium6
	397	+	indication for the treatment of stage four advanced metastatic cancer; or7
	398	+	(II) (b) Peer-reviewed medical literature.8
	399	+	(b) As used in this subsection (1), "stage four advanced metastatic9
	400	+	cancer" means cancer that has spread from the primary or original site of10
	401	+	the cancer to nearby tissues, lymph nodes, or other parts of the body.11
	402	+	(2) (a) Notwithstanding section 10-16-145, a carrier that provides12
	403	+	prescription drug benefits shall:13
	404	+	(I) (a) Provide coverage for at least one atypical opioid that has14
	405	+	been approved by the FDA for the treatment of acute or chronic pain at15
	406	+	the lowest tier of the carrier's drug formulary and not require step-therapy16
	407	+	STEP THERAPY or prior authorization, as defined in section 10-16-112.517
	408	+	(7)(d), for that atypical opioid; and18
	409	+	(II) (b) Not require step-therapy STEP THERAPY for the prescription19
	410	+	and use of any additional atypical opioid medications that have been20
	411	+	approved by the FDA for the treatment of acute or chronic pain.21
	412	+	(b) As used in this subsection (2), "atypical opioid" means an22
	413	+	opioid agonist with a documented safer side-effect profile and less risk of23
	414	+	addiction than older opium-based medications.24
230	415		(3) A
231		-	CARRIER, PRIVATE UTILIZATION REVIEW ORGANIZATION , OR
232		-	PBM SHALL:
233		-	(a) M
234		-	AKE THE CLINICAL REVIEW CRITERIA AND THE STEP THERAPY
235		-	EXEMPTION PROCESS AVAILABLE ON THEIR WEBSITES
236		-	; AND
237		-	(b) UPON WRITTEN REQUEST , PROVIDE ALL SPECIFIC CLINICAL
238		-	REVIEW CRITERIA AND OTHER CLINICAL INFORMATION RELATING TO A
239		-	PAGE 5-HOUSE BILL 22-1370 COVERED PERSON'S PARTICULAR CONDITION OR DISEASE , INCLUDING
240		-	CLINICAL REVIEW CRITERIA RELATING TO A STEP
241		-	-THERAPY EXCEPTION, TO
242		-	THE REQUESTER
243		-	.
244		-	(4) (a) A
245		-	CARRIER, A PRIVATE UTILIZATION REVIEW ORGANIZATION ,
246		-	OR A PBM SHALL GRANT AN EXCEPTION TO STEP THERAPY IF THE
247		-	PRESCRIBING PROVIDER SUBMITS JUSTIFICATION AND SUPPORTING CLINICAL
248		-	DOCUMENTATION
249		-	, IF NEEDED, THAT STATES:
250		-	(I) T
251		-	HE PROVIDER ATTESTS THAT THE REQUIRED PRESCRIPTION DRUG
252		-	IS CONTRAINDICATED OR WILL LIKELY CAUSE AN ADVERSE REACTION OR
253		-	HARM TO THE COVERED PERSON
254		-	;
255		-	(II) T
256		-	HE REQUIRED PRESCRIPTION DRUG IS INEFFECTIVE BASED ON
257		-	THE KNOWN CLINICAL CHARACTERISTICS OF THE COVERED PERSON AND THE
258		-	KNOWN CHARACTERISTICS OF THE PRESCRIPTION DRUG REGIMEN
259		-	;
260		-	(III) T
261		-	HE COVERED PERSON HAS TRIED, WHILE UNDER THE COVERED
262		-	PERSON
263		-	'S CURRENT OR PREVIOUS HEALTH BENEFIT PLAN , THE REQUIRED
264		-	PRESCRIPTION DRUG OR ANOTHER PRESCRIPTION DRUG IN THE SAME
265		-	PHARMACOLOGIC CLASS OR WITH THE SAME MECHANISM OF ACTION
266		-	, AND
267		-	THE USE OF THE PRESCRIPTION DRUG BY THE COVERED PERSON WAS
268		-	DISCONTINUED DUE TO LACK OF EFFICACY OR EFFECTIVENESS
269		-	, DIMINISHED
270		-	EFFECT
271		-	, OR AN ADVERSE EVENT;
272		-	(IV) T
273		-	HE COVERED PERSON, WHILE ON THE COVERED PERSON 'S
274		-	CURRENT OR PREVIOUS HEALTH BENEFIT PLAN
275		-	, IS STABLE ON A PRESCRIPTION
276		-	DRUG SELECTED BY THE PRESCRIBING PROVIDER FOR THE MEDICAL
277		-	CONDITION UNDER CONSIDERATION AFTER UNDERGOING STEP THERAPY OR
278		-	AFTER HAVING SOUGHT AND RECEIVED A STEP
279		-	-THERAPY EXCEPTION.
280		-	(b) (I) E
281		-	XCEPT AS PROVIDED IN SUBSECTION (4)(b)(II) OF THIS
282		-	SECTION
283		-	, A CARRIER, ORGANIZATION, OR PBM SHALL GRANT OR DENY A
284		-	STEP THERAPY EXCEPTION REQUEST OR AN APPEAL OF A DENIAL OF A
285		-	REQUEST WITHIN
286		-	:
287		-	(A) T
288		-	HREE BUSINESS DAYS AFTER RECEIPT OF THE REQUEST ; OR
289		-	(B) IN CASES WHERE EXIGENT CIRCUMSTANCES EXIST , WITHIN
290		-	TWENTY
291		-	-FOUR HOURS AFTER RECEIPT OF THE REQUEST .
292		-	PAGE 6-HOUSE BILL 22-1370 (II) IF A REQUEST FOR A STEP THERAPY EXCEPTION OR AN APPEAL OF
293		-	A DENIAL OF A REQUEST IS INCOMPLETE OR IF ADDITIONAL CLINICALLY
294		-	RELEVANT INFORMATION IS REQUIRED
295		-	, THE CARRIER, ORGANIZATION, OR
296		-	PBM SHALL NOTIFY THE PRESCRIBING PROVIDER WITHIN SEVENTY -TWO
297		-	HOURS AFTER SUBMISSION OF THE REQUEST
298		-	, OR WITHIN TWENTY-FOUR
299		-	HOURS AFTER THE SUBMISSION OF THE REQUEST IF EXIGENT CIRCUMSTANCES
300		-	EXIST
301		-	, THAT THE REQUEST OR APPEAL IS INCOMPLETE OR THAT ADDITIONAL
302		-	CLINICALLY RELEVANT INFORMATION IS REQUIRED
303		-	. THE CARRIER,
304		-	ORGANIZATION, OR PBM MUST SPECIFY THE ADDITIONAL INFORMATION
305		-	THAT IS REQUIRED IN ORDER TO CONSIDER THE STEP THERAPY EXCEPTION
306		-	REQUEST OR THE APPEAL OF THE DENIAL OF THE REQUEST PURSUANT TO THE
307		-	CRITERIA DESCRIBED IN SUBSECTION
308		-	(4)(a) OF THIS SECTION. ONCE THE
309		-	REQUESTED INFORMATION IS SUBMITTED TO THE CARRIER
310		-	, ORGANIZATION,
311		-	OR PBM, THE APPLICABLE PERIOD TO GRANT OR DENY A STEP THERAPY
312		-	EXCEPTION REQUEST OR AN APPEAL OF A DENIAL OF A REQUEST
313		-	, AS
314		-	SPECIFIED IN SUBSECTION
315		-	(4)(b)(I) OF THIS SECTION, APPLIES.
316		-	(III) I
317		-	F A CARRIER, ORGANIZATION, OR PBM DOES NOT MAKE A
318		-	DETERMINATION REGARDING THE STEP THERAPY EXCEPTION REQUEST OR
319		-	THE APPEAL OF THE DENIAL OF THE REQUEST OR DOES NOT MAKE A REQUEST
320		-	FOR ADDITIONAL OR CLINICALLY RELEVANT INFORMATION WITHIN THE
321		-	REQUIRED TIME
322		-	, THE STEP THERAPY EXCEPTION REQUEST OR THE APPEAL OF
323		-	THE DENIAL OF THE REQUEST IS DEEMED GRANTED
324		-	.
325		-	(c) I
326		-	F THE INITIAL REQUEST FOR A STEP-THERAPY EXCEPTION IS
327		-	DENIED
328		-	, THE CARRIER, ORGANIZATION, OR PBM SHALL INFORM THE
329		-	COVERED PERSON IN WRITING THAT THE COVERED PERSON HAS THE RIGHT TO
330		-	AN INTERNAL OR EXTERNAL REVIEW OR AN APPEAL OF THE ADVERSE
331		-	DETERMINATION PURSUANT TO SECTIONS
332		-	10-16-113 AND 10-16-113.5.
333		-	(d) A
334		-	CARRIER, AN ORGANIZATION, OR A PBM SHALL AUTHORIZE
335		-	COVERAGE FOR THE PRESCRIPTION DRUG PRESCRIBED BY THE COVERED
336		-	PERSON
337		-	'S PRESCRIBING PROVIDER WHEN THE STEP -THERAPY EXCEPTION
338		-	REQUEST IS GRANTED
339		-	.
340		-	(5) T
341		-	HIS SECTION DOES NOT PROHIBIT:
342		-	(a) A
343		-	CARRIER, AN ORGANIZATION, OR A PBM FROM REQUIRING A
344		-	COVERED PERSON TO TRY A GENERIC EQUIVALENT DRUG
345		-	, A BIOSIMILAR
346		-	DRUG
347		-	, OR AN INTERCHANGEABLE BIOLOGICAL PRODUCT AS DEFINED BY 42
348		-	PAGE 7-HOUSE BILL 22-1370 U.S.C. SEC. 262 (i)(3), UNLESS THE COVERED PERSON OR COVERED PERSON 'S
349		-	PRESCRIBING PROVIDER HAS REQUESTED A STEP
350		-	-THERAPY EXCEPTION AND
351		-	THE PRESCRIBED DRUG MEETS THE CRITERIA FOR A STEP
352		-	-THERAPY
353		-	EXCEPTION SPECIFIED IN SUBSECTION
354		-	(4)(a) OF THIS SECTION;
355		-	(b) A
356		-	CARRIER, AN ORGANIZATION, OR A PBM FROM REQUIRING A
357		-	PHARMACIST TO MAKE SUBSTITUTIONS OF PRESCRIPTION DRUGS CONSISTENT
358		-	WITH PART
359		-	5 OF ARTICLE 280 OF TITLE 12; OR
360		-	(c) A PROVIDER FROM PRESCRIBING A DRUG THAT IS DETERMINED TO
361		-	BE MEDICALLY APPROPRIATE
362		-	.
363		-	(6) T
364		-	HE COMMISSIONER MAY PROMULGATE RULES TO IMPLEMENT
365		-	AND ENFORCE THIS SECTION
366		-	.
367		-	SECTION 4. In Colorado Revised Statutes, amend as it exists
368		-	until January 1, 2023, 10-16-145.5 as follows:
369		-	10-16-145.5. Step therapy prohibited - stage four advanced
370		-	metastatic cancer - definitions. (1) Notwithstanding section 10-16-145,
371		-	a carrier that provides coverage under a health benefit plan for the treatment
372		-	of stage four advanced metastatic cancer shall not limit or exclude coverage
373		-	under the health benefit plan for a drug approved by the United States food
374		-	and drug administration FDA and that is on the carrier's prescription drug
375		-	formulary by mandating that a covered person with stage four advanced
376		-	metastatic cancer undergo step-therapy
377		-	STEP THERAPY if the use of the
378		-	approved drug is consistent with:
379		-	(a) The United States food and drug administration-approved
380		-	FDA-APPROVED indication or the National Comprehensive Cancer Network
381		-	drugs and biologics compendium indication for the treatment of stage four
382		-	advanced metastatic cancer; or
383		-	(b) Peer-reviewed medical literature.
384		-	(2) For the purposes of
385		-	AS USED IN this section:
386		-	(a) "Stage four advanced metastatic cancer" means cancer that has
387		-	spread from the primary or original site of the cancer to nearby tissues,
388		-	lymph nodes, or other parts of the body.
389		-	PAGE 8-HOUSE BILL 22-1370 (b) "STEP THERAPY" HAS THE SAME MEANING AS SPECIFIED IN
390		-	SECTION
391		-	10-16-145 (1)(g).
392		-	SECTION 5. In Colorado Revised Statutes, amend as it will
393		-	become effective January 1, 2023, 10-16-145.5 as follows:
394		-	10-16-145.5. Step therapy - prior authorization - prohibited -
395		-	stage four advanced metastatic cancer - opioid prescription -
396		-	definitions. (1) (a)
397		-	Notwithstanding section 10-16-145, a carrier that
398		-	provides coverage under a health benefit plan for the treatment of stage four
399		-	advanced metastatic cancer shall not limit or exclude coverage under the
400		-	health benefit plan for a drug that is approved by the FDA and that is on the
401		-	carrier's prescription drug formulary by mandating that a covered person
402		-	with stage four advanced metastatic cancer undergo step-therapy
403		-	STEP
404		-	THERAPY
405		-	if the use of the approved drug is consistent with:
406		-	(I)
407		-	(a) The FDA-approved indication or the National Comprehensive
408		-	Cancer Network drugs and biologics compendium indication for the
409		-	treatment of stage four advanced metastatic cancer; or
410		-	(II)
411		-	(b) Peer-reviewed medical literature.
412		-	(b) As used in this subsection (1), "stage four advanced metastatic
413		-	cancer" means cancer that has spread from the primary or original site of the
414		-	cancer to nearby tissues, lymph nodes, or other parts of the body.
415		-	(2) (a) Notwithstanding section 10-16-145, a carrier that provides
416		-	prescription drug benefits shall:
417		-	(I) (a) Provide coverage for at least one atypical opioid that has been
418		-	approved by the FDA for the treatment of acute or chronic pain at the
419		-	lowest tier of the carrier's drug formulary and not require step therapy or
420		-	prior authorization, as defined in section 10-16-112.5 (7)(d), for that
421		-	atypical opioid; and
422		-	(II)
423		-	(b) Not require step therapy for the prescription and use of any
424		-	additional atypical opioid medications that have been approved by the FDA
425		-	for the treatment of acute or chronic pain.
426		-	(b) As used in this subsection (2), "atypical opioid" means an opioid
427		-	PAGE 9-HOUSE BILL 22-1370 agonist with a documented safer side-effect profile and less risk of
428		-	addiction than older opium-based medications.
429		-	(3) AS USED IN THIS SECTION:
	416	+	S USED IN THIS SECTION:25
430	417		(a) "A
431		-	TYPICAL OPIOID" MEANS AN OPIOID AGONIST WITH A
432		-	DOCUMENTED SAFER SIDE
433		-	-EFFECT PROFILE AND LESS RISK OF ADDICTION
434		-	THAN OLDER OPIUM
435		-	-BASED MEDICATIONS.
	418	+	TYPICAL OPIOID" MEANS AN OPIOID AGONIST WITH A26
	419	+	DOCUMENTED SAFER SIDE-EFFECT PROFILE AND LESS RISK OF ADDICTION27
	420	+	1370
	421	+	-12- THAN OLDER OPIUM-BASED MEDICATIONS.1
436	422		(b) "S
437		-	TAGE FOUR ADVANCED METASTATIC CANCER " MEANS CANCER
438		-	THAT HAS SPREAD FROM THE PRIMARY OR ORIGINAL SITE OF THE CANCER TO
439		-	NEARBY TISSUES
440		-	, LYMPH NODES, OR OTHER PARTS OF THE BODY.
441		-	(c) "S
442		-	TEP THERAPY" HAS THE SAME MEANING AS SPECIFIED IN
443		-	SECTION
444		-	10-16-145 (1)(g).
445		-	SECTION 6. In Colorado Revised Statutes, add 10-16-156 as
446		-	follows:
447		-	10-16-156. Prescription drugs - rebates - consumer cost
448		-	reduction - point of sale - study - report - rules - definitions. (1) A
449		-	S
450		-	USED IN THIS SECTION
451		-	, UNLESS THE CONTEXT OTHERWISE REQUIRES :
452		-	(a) "D
453		-	ISCOUNT" MEANS PRICE REDUCTIONS OR CONCESSIONS ,
454		-	INCLUDING BASE PRICE CONCESSIONS OR OTHER CONTRACTUAL AGREEMENTS
455		-	MADE BY A MANUFACTURER OR ITS AFFILIATE
456		-	, THAT REDUCE PAYMENT OR
457		-	LIABILITY FOR PRESCRIPTION DRUGS INCLUDING A REDUCTION IN THE TOTAL
458		-	AMOUNT PAID FOR PRESCRIPTION DRUGS
459		-	, WITHOUT REGARD TO
460		-	PERFORMANCE
461		-	, VOLUME, OR UTILIZATION OF THE DRUGS AND ALL OTHER
462		-	COMPENSATION THAT REDUCES PAYMENT OR LIABILITY FOR PRESCRIPTION
463		-	DRUGS
464		-	. "DISCOUNT" DOES NOT INCLUDE A REBATE.
465		-	(b) "H
466		-	EALTH INSURER" MEANS A CARRIER:
467		-	(I) A
468		-	S DEFINED IN SECTION 10-16-102 (8); AND
469		-	(II) AS DEFINED IN SECTION 24-50-603 (2).
470		-	(c) "M
471		-	ANUFACTURER" HAS THE SAME MEANING AS SET FORTH IN
472		-	SECTION
473		-	10-16-1401 (16).
474		-	PAGE 10-HOUSE BILL 22-1370 (d) "PRESCRIPTION DRUG" HAS THE SAME MEANING AS SET FORTH IN
475		-	SECTION
476		-	12-280-103 (42); EXCEPT THAT THE TERM INCLUDES ONLY
477		-	PRESCRIPTION DRUGS THAT ARE INTENDED FOR HUMAN USE
478		-	.
479		-	(e) "R
480		-	EBATE" MEANS ALL PRICE CONCESSIONS MADE BY A
481		-	MANUFACTURER OR ITS AFFILIATE THAT ACCRUE TO A
482		-	PBM OR ITS HEALTH
483		-	INSURER CLIENT
484		-	, INCLUDING CREDITS OR INCENTIVES THAT ARE BASED ON
485		-	ACTUAL OR ESTIMATED UTILIZATION OF PRESCRIPTION DRUGS
486		-	; THAT RESULT
487		-	IN THE PLACEMENT OF A PRESCRIPTION DRUG IN A PREFERRED DRUG LIST OR
488		-	FORMULARY OR PREFERRED FORMULARY POSITION
489		-	; OR THAT ARE
490		-	ASSOCIATED WITH CLAIMS ADMINISTERED ON BEHALF OF AN INSURER
491		-	CLIENT
492		-	. "REBATE" ALSO INCLUDES CREDITS, INCENTIVES, REFUNDS, AND ALL
493		-	OTHER COMPENSATION THAT IS PERFORMANCE
494		-	-BASED. "REBATE" DOES NOT
495		-	INCLUDE A DISCOUNT
496		-	.
497		-	(2) F
498		-	OR EACH HEALTH BENEFIT PLAN ISSUED OR RENEWED ON OR
499		-	AFTER
500		-	JANUARY 1, 2024, A HEALTH INSURER SHALL ENSURE THAT ONE
501		-	HUNDRED PERCENT OF DISC OUNTS RECEIVED OR TO BE RECEIVED FROM A
502		-	MANUFACTURER IN CONNECTION WITH DISPENSING OR ADMINISTERING
503		-	PRESCRIPTION DRUGS INCLUDED IN THE HEALTH INSURER
504		-	'S FORMULARY, AS
505		-	DEMONSTRATED IN THE HEALTH INSURER
506		-	'S RATE FILING PURSUANT TO
507		-	SECTION
508		-	10-16-107, FOR THAT PLAN YEAR ARE USED TO REDUCE COSTS .
509		-	(3) F
510		-	OR EACH HEALTH BENEFIT PLAN ISSUED OR RENEWED ON OR
511		-	AFTER
512		-	JANUARY 1, 2024, A HEALTH INSURER SHALL ENSURE THAT :
513		-	(a) O
514		-	NE HUNDRED PERCENT OF THE ESTIMATED REBATES RECEIVED
515		-	OR TO BE RECEIVED IN CONNECTION WITH DISPENSING OR ADMINISTERING
516		-	PRESCRIPTION DRUGS INCLUDED IN THE HEALTH INSURER
517		-	'S FORMULARY FOR
518		-	THAT PLAN YEAR ARE USED TO REDUCE POLICYHOLDER COSTS
519		-	;
520		-	(b) F
521		-	OR SMALL GROUP AND LARGE GROUP HEALTH BENEFIT PLANS ,
522		-	ALL REBATES ARE USED TO REDUCE EMPLOYER OR INDIVIDUAL EMPLOYEE
523		-	COSTS
524		-	; AND
525		-	(c) FOR INDIVIDUAL HEALTH BENEFIT PLANS, ALL REBATES ARE USED
526		-	TO REDUCE CONSUMER PREMIUMS AND OUT
527		-	-OF-POCKET COSTS FOR
528		-	PRESCRIPTION DRUGS AND THAT HEALTH INSURERS WILL MAXIMIZE THE USE
529		-	OF REBATES TO REDUCE CONSUMER OUT
530		-	-OF-POCKET COSTS AT THE POINT OF
531		-	SALE NOT TO EXCEED THE CONSUMER
532		-	'S ACTUAL OUT-OF-POCKET COSTS FOR
533		-	PAGE 11-HOUSE BILL 22-1370 THE PRESCRIPTION DRUG IF THE USE OF SUCH REBATES WILL NOT :
534		-	(I) I
535		-	NCREASE PREMIUMS;
536		-	(II) C
537		-	HANGE THE ACTUARIAL VALUE OF THE PLAN INCONSISTENT
538		-	WITH FEDERAL AND STATE REQUIREMENTS
539		-	; OR
540		-	(III) OTHERWISE RESULT IN AN IMPACT THAT IS NOT IN THE BEST
541		-	INTEREST OF CONSUMERS
542		-	.
543		-	(4) (a) O
544		-	N OR BEFORE JUNE 1, 2023, THE DIVISION SHALL CONDUCT
545		-	AND COMPLETE A STUDY TO EVALUATE HOW REBATES MAY BE APPLIED IN
546		-	THE INDIVIDUAL MARKET TO REDUCE A COVERED PERSON
547		-	'S OUT-OF-POCKET
548		-	COSTS AT THE POINT OF SALE OR TO REDUCE OUT
549		-	-OF-POCKET COSTS IN
550		-	PRESCRIPTION DRUG TIERS
551		-	, TAKING INTO CONSIDERATION THE FOLLOWING
552		-	FACTORS
553		-	:
554		-	(I) P
555		-	REMIUM IMPACTS;
556		-	(II) C
557		-	HANGES IN THE PLAN'S ACTUARIAL VALUE; AND
558		-	(III) OTHER POTENTIAL IMPACTS TO CONSUMERS .
559		-	(b) R
560		-	EGARDLESS OF THE RESULTS OF THE STUDY, A HEALTH INSURER
561		-	SHALL COMPLY WITH SUBSECTION
562		-	(3) OF THIS SECTION.
563		-	(c) T
564		-	HE DIVISION MAY CONTRACT WITH A THIRD PARTY TO CONDUCT
565		-	THE STUDY REQUIRED BY THIS SUBSECTION
566		-	(4). THE COMMISSIONER IS NOT
567		-	REQUIRED TO COMPLY WITH THE
568		-	"PROCUREMENT CODE", ARTICLES 101 TO
569		-	112 OF TITLE 24, FOR THE PURPOSES OF THIS SECTION, BUT SHALL ENSURE A
570		-	COMPETITIVE PROCESS IS USED TO SELECT A THIRD PARTY TO CONDUCT THE
571		-	STUDY
572		-	.
573		-	(5) E
574		-	ACH HEALTH INSURER SHALL REPORT ANNUALLY :
575		-	(a) I
576		-	N A FORM AND MANNER DETERMINED BY THE COMMISSIONER ,
577		-	DATA DEMONSTRATING THAT ALL DISCOUNTS AND REBATES RECEIVED BY
578		-	HEALTH INSURERS ARE USED TO REDUCE COSTS FOR POLICYHOLDERS IN
579		-	COMPLIANCE WITH THIS SECTION
580		-	. THE COMMISSIONER MAY USE DISCOUNT
581		-	AND REBATE DATA SUBMITTED BY HEALTH INSURERS TO THE ALL
582		-	-PAYER
583		-	PAGE 12-HOUSE BILL 22-1370 HEALTH CLAIMS DATABASE DESCRIBED IN SECTION 25.5-1-204 TO THE
584		-	EXTENT SUCH DATA ARE AVAILABLE FROM THE ALL
585		-	-PAYER HEALTH CLAIMS
586		-	DATABASE
587		-	.
588		-	(b) A
589		-	N ACTUARIAL CERTIFICATION THAT ATTESTS THAT :
590		-	(I) T
591		-	HE HEALTH INSURER AND PBM ARE IN COMPLIANCE WITH
592		-	SUBSECTIONS
593		-	(2) AND (3) OF THIS SECTION; AND
594		-	(II) THE DATA REPORTED AS REQUIRED BY THIS SECTION ARE
595		-	ACCURATE
596		-	.
597		-	(6) T
598		-	HE DIVISION MAY USE DATA FROM THE DEPARTMENT OF HEALTH
599		-	CARE POLICY AND FINANCING
600		-	, THE ALL-PAYER HEALTH CLAIMS DATABASE
601		-	DESCRIBED IN SECTION
602		-	25.5-1-204, AND OTHER SOURCES TO VERIFY THAT A
603		-	HEALTH INSURER AND
604		-	PBM ARE IN COMPLIANCE WITH THIS SECTION.
605		-	(7) I
606		-	NFORMATION SUBMITTED BY THE HEALTH INSURERS AND PBMS
607		-	TO THE DIVISION IN ACCORDANCE WITH THIS SECTION IS SUBJECT TO PUBLIC
608		-	INSPECTION ONLY TO THE EXTENT ALLOWED UNDER THE
609		-	"COLORADO OPEN
610		-	RECORDS ACT", PART 2 OF ARTICLE 72 OF TITLE 24, AND IN NO CASE SHALL
611		-	TRADE
612		-	-SECRET, CONFIDENTIAL, OR PROPRIETARY INFORMATION BE
613		-	DISCLOSED TO ANY PERSON WHO IS NOT OTHERWISE AUTHORIZED TO ACCESS
614		-	SUCH INFORMATION
615		-	.
616		-	(8) T
617		-	HIS SECTION DOES NOT PROHIBIT A HEALTH INSURER FROM
618		-	DECREASING COST
619		-	-SHARING AMOUNTS OR PREMIUMS BY AN AMOUNT
620		-	GREATER THAN THE AMOUNT REQUIRED IN SUBSECTION
621		-	(2) OR (3) OF THIS
622		-	SECTION
623		-	.
624		-	(9) T
625		-	HE REQUIREMENTS OF SUBSECTIONS (2), (3), AND (5) OF THIS
626		-	SECTION APPLY TO A SELF
627		-	-FUNDED HEALTH BENEFIT PLAN AND ITS PLAN
628		-	MEMBERS ONLY IF THE ENTITY THAT PROVIDES THE PLAN ELECTS TO BE
629		-	SUBJECT TO SUBSECTIONS
630		-	(2), (3), AND (5) OF THIS SECTION FOR ITS
631		-	MEMBERS IN
632		-	COLORADO.
633		-	(10) T
634		-	HE COMMISSIONER SHALL PROMULGATE RULES TO IMPLEMENT
635		-	AND ENFORCE THIS SECTION
636		-	.
637		-	SECTION 7. In Colorado Revised Statutes, add 25.5-5-513 as
638		-	PAGE 13-HOUSE BILL 22-1370 follows:
639		-	25.5-5-513. Pharmacy benefits - prescription drugs - rebates -
640		-	analysis. (1) B
641		-	EGINNING IN 2023, THE STATE DEPARTMENT SHALL , IN
642		-	COLLABORATION WITH THE ADMINISTRATOR OF THE ALL
643		-	-PAYER HEALTH
644		-	CLAIMS DATABASE DESCRIBED IN SECTION
645		-	25.5-1-204, CONDUCT AN ANNUAL
646		-	ANALYSIS OF THE PRESCRIPTION DRUG REBATES RECEIVED IN THE PREVIOUS
647		-	CALENDAR YEAR
648		-	, BY HEALTH INSURANCE CARRIER AND PRESCRIPTION DRUG
649		-	TIER
650		-	. THE ANALYSIS, USING DATA FROM THE ALL-PAYER HEALTH CLAIMS
651		-	DATABASE AND OTHER SOURCES
652		-	, MUST BE COMPLETED ON OR BEFORE MAY
653		-	1 OF EACH YEAR.
	423	+	TAGE FOUR ADVANCED METASTATIC CANCER " MEANS2
	424	+	CANCER THAT HAS SPREAD FROM THE PRIMARY OR ORIGINAL SITE OF THE3
	425	+	CANCER TO NEARBY TISSUES , LYMPH NODES, OR OTHER PARTS OF THE4
	426	+	BODY.5
	427	+	(c)
	428	+	"STEP THERAPY" HAS THE SAME MEANING AS SPECIFIED IN6
	429	+	SECTION 10-16-145 (1)(g).7
	430	+	SECTION 6. In Colorado Revised Statutes, add 10-16-155 as8
	431	+	follows:9
	432	+	10
	433	+	10-16-155. Prescription drugs - rebates - consumer cost11
	434	+	reduction - point of sale - study - report - rules - definitions. (1) AS12
	435	+	USED IN THIS SECTION, UNLESS THE CONTEXT OTHERWISE REQUIRES :13
	436	+	(a) "DISCOUNT" MEANS PRICE REDUCTIONS OR CONCESSIONS,14
	437	+	INCLUDING BASE PRICE CONCESSIONS OR OTHER CONTRACTUAL15
	438	+	AGREEMENTS MADE BY A MANUFACTURER OR ITS AFFILIATE , THAT REDUCE16
	439	+	PAYMENT OR LIABILITY FOR PRESCRIPTION DRUGS INCLUDING A17
	440	+	REDUCTION IN THE TOTAL AMOUNT PAID FOR PRESCRIPTION DRUGS ,18
	441	+	WITHOUT REGARD TO PERFORMANCE, VOLUME, OR UTILIZATION OF THE19
	442	+	DRUGS AND ALL OTHER COMPENSATION THAT REDUCES PAYMENT OR20
	443	+	LIABILITY FOR PRESCRIPTION DRUGS. "DISCOUNT" DOES NOT INCLUDE A21
	444	+	REBATE.22
	445	+	(b) "HEALTH INSURER" MEANS A CARRIER:23
	446	+	(I) AS DEFINED IN SECTION 10-16-102 (8); AND24
	447	+	(II) AS DEFINED IN SECTION 24-50-603 (2).25
	448	+	(c) "MANUFACTURER" HAS THE SAME MEANING AS SET FORTH IN26
	449	+	SECTION 10-16-1401 (16).27
	450	+	1370
	451	+	-13- (d) "PRESCRIPTION DRUG" HAS THE SAME MEANING AS SET FORTH1
	452	+	IN SECTION 12-280-103 (42); EXCEPT THAT THE TERM INCLUDES ONLY2
	453	+	PRESCRIPTION DRUGS THAT ARE INTENDED FOR HUMAN USE .3
	454	+	(e) "REBATE" MEANS ALL PRICE CONCESSIONS MADE BY A4
	455	+	MANUFACTURER OR ITS AFFILIATE THAT ACCRUE TO A PBM OR ITS HEALTH5
	456	+	INSURER CLIENT, INCLUDING CREDITS OR INCENTIVES THAT ARE BASED ON6
	457	+	ACTUAL OR ESTIMATED UTILIZATION OF PRESCRIPTION DRUGS; THAT7
	458	+	RESULT IN THE PLACEMENT OF A PRESCRIPTION DRUG IN A PREFERRED8
	459	+	DRUG LIST OR FORMULARY OR PREFERRED FORMULARY POSITION ; OR THAT9
	460	+	ARE ASSOCIATED WITH CLAIMS ADMINISTERED ON BEHALF OF AN INSURER10
	461	+	CLIENT. "REBATE" ALSO INCLUDES CREDITS, INCENTIVES, REFUNDS, AND11
	462	+	ALL OTHER COMPENSATION THAT IS PERFORMANCE-BASED. "REBATE"12
	463	+	DOES NOT INCLUDE A DISCOUNT.13
	464	+	(2) FOR EACH HEALTH BENEFIT PLAN ISSUED OR RENEWED ON OR14
	465	+	AFTER JANUARY 1, 2024, A HEALTH INSURER SHALL ENSURE THAT ONE15
	466	+	HUNDRED PERCENT OF DISCOUNTS RECEIVED OR TO BE RECEIVED FROM A16
	467	+	MANUFACTURER IN CONNECTION WITH DISPENSING OR ADMINISTERING17
	468	+	PRESCRIPTION DRUGS INCLUDED IN THE HEALTH INSURER'S FORMULARY,18
	469	+	AS DEMONSTRATED IN THE HEALTH INSURER'S RATE FILING PURSUANT TO19
	470	+	SECTION 10-16-107, FOR THAT PLAN YEAR ARE USED TO REDUCE COSTS .20
	471	+	(3) FOR EACH HEALTH BENEFIT PLAN ISSUED OR RENEWED ON OR21
	472	+	AFTER JANUARY 1, 2024, A HEALTH INSURER SHALL ENSURE THAT :22
	473	+	(a) ONE HUNDRED PERCENT OF THE ESTIMATED REBATES RECEIVED23
	474	+	OR TO BE RECEIVED IN CONNECTION WITH DISPENSING OR ADMINISTERING24
	475	+	PRESCRIPTION DRUGS INCLUDED IN THE HEALTH INSURER'S FORMULARY25
	476	+	FOR THAT PLAN YEAR ARE USED TO REDUCE POLICYHOLDER COSTS ;26
	477	+	(b) FOR SMALL GROUP AND LARGE GROUP HEALTH BENEFIT PLANS,27
	478	+	1370
	479	+	-14- ALL REBATES ARE USED TO REDUCE EMPLOYER OR INDIVIDUAL EMPLOYEE1
	480	+	COSTS; AND2
	481	+	(c) FOR INDIVIDUAL HEALTH BENEFIT PLANS, ALL REBATES ARE3
	482	+	USED TO REDUCE CONSUMER PREMIUMS AND OUT-OF-POCKET COSTS FOR4
	483	+	PRESCRIPTION DRUGS AND THAT HEALTH INSURERS WILL MAXIMIZE THE5
	484	+	USE OF REBATES TO REDUCE CONSUMER OUT-OF-POCKET COSTS AT THE6
	485	+	POINT OF SALE NOT TO EXCEED THE CONSUMER'S ACTUAL OUT-OF-POCKET7
	486	+	COSTS FOR THE PRESCRIPTION DRUG IF THE USE OF SUCH REBATES WILL8
	487	+	NOT:9
	488	+	(I) INCREASE PREMIUMS;10
	489	+	(II) CHANGE THE ACTUARIAL VALUE OF THE PLAN INCONSISTENT11
	490	+	WITH FEDERAL AND STATE REQUIREMENTS ; OR12
	491	+	(III) OTHERWISE RESULT IN AN IMPACT THAT IS NOT IN THE BEST13
	492	+	INTEREST OF CONSUMERS.14
	493	+	(4) (a) ON OR BEFORE JUNE 1, 2023, THE DIVISION SHALL CONDUCT15
	494	+	AND COMPLETE A STUDY TO EVALUATE HOW REBATES MAY BE APPLIED IN16
	495	+	THE INDIVIDUAL MARKET TO REDUCE A COVERED PERSON 'S17
	496	+	OUT-OF-POCKET COSTS AT THE POINT OF SALE OR TO REDUCE18
	497	+	OUT-OF-POCKET COSTS IN PRESCRIPTION DRUG TIERS , TAKING INTO19
	498	+	CONSIDERATION THE FOLLOWING FACTORS :20
	499	+	(I) PREMIUM IMPACTS;21
	500	+	(II) CHANGES IN THE PLAN'S ACTUARIAL VALUE; AND22
	501	+	(III) OTHER POTENTIAL IMPACTS TO CONSUMERS .23
	502	+	(b) REGARDLESS OF THE RESULTS OF THE STUDY, A HEALTH24
	503	+	INSURER SHALL COMPLY WITH SUBSECTION (3) OF THIS SECTION.25
	504	+	(c) THE DIVISION MAY CONTRACT WITH A THIRD PARTY TO26
	505	+	CONDUCT THE STUDY REQUIRED BY THIS SUBSECTION (4). THE27
	506	+	1370
	507	+	-15- COMMISSIONER IS NOT REQUIRED TO COMPLY WITH THE "PROCUREMENT1
	508	+	CODE", ARTICLES 101 TO 112 OF TITLE 24, FOR THE PURPOSES OF THIS2
	509	+	SECTION, BUT SHALL ENSURE A COMPETITIVE PROCESS IS USED TO SELECT3
	510	+	A THIRD PARTY TO CONDUCT THE STUDY .4
	511	+	(5) EACH HEALTH INSURER SHALL REPORT ANNUALLY :5
	512	+	(a) IN A FORM AND MANNER DETERMINED BY THE COMMISSIONER ,6
	513	+	DATA DEMONSTRATING THAT ALL DISCOUNTS AND REBATES RECEIVED BY7
	514	+	HEALTH INSURERS ARE USED TO REDUCE COSTS FOR POLICYHOLDERS IN8
	515	+	COMPLIANCE WITH THIS SECTION. THE COMMISSIONER MAY USE DISCOUNT9
	516	+	AND REBATE DATA SUBMITTED BY HEALTH INSURERS TO THE ALL-PAYER10
	517	+	HEALTH CLAIMS DATABASE DESCRIBED IN SECTION 25.5-1-204 TO THE11
	518	+	EXTENT SUCH DATA ARE AVAILABLE FROM THE ALL -PAYER HEALTH12
	519	+	CLAIMS DATABASE.13
	520	+	(b) AN ACTUARIAL CERTIFICATION THAT ATTESTS THAT :14
	521	+	(I) THE HEALTH INSURER AND PBM ARE IN COMPLIANCE WITH15
	522	+	SUBSECTIONS (2) AND (3) OF THIS SECTION; AND16
	523	+	(II) THE DATA REPORTED AS REQUIRED BY THIS SECTION ARE17
	524	+	ACCURATE.18
	525	+	(6) THE DIVISION MAY USE DATA FROM THE DEPARTMENT OF19
	526	+	HEALTH CARE POLICY AND FINANCING, THE ALL-PAYER HEALTH CLAIMS20
	527	+	DATABASE DESCRIBED IN SECTION 25.5-1-204, AND OTHER SOURCES TO21
	528	+	VERIFY THAT A HEALTH INSURER AND PBM ARE IN COMPLIANCE WITH THIS22
	529	+	SECTION.23
	530	+	(7) INFORMATION SUBMITTED BY THE HEALTH INSURERS AND24
	531	+	PBMS TO THE DIVISION IN ACCORDANCE WITH THIS SECTION IS SUBJECT TO25
	532	+	PUBLIC INSPECTION ONLY TO THE EXTENT ALLOWED UNDER THE26
	533	+	"COLORADO OPEN RECORDS ACT", PART 2 OF ARTICLE 72 OF TITLE 24,27
	534	+	1370
	535	+	-16- AND IN NO CASE SHALL TRADE-SECRET, CONFIDENTIAL, OR PROPRIETARY1
	536	+	INFORMATION BE DISCLOSED TO ANY PERSON WHO IS NOT OTHERWISE2
	537	+	AUTHORIZED TO ACCESS SUCH INFORMATION .3
	538	+	(8) THIS SECTION DOES NOT PROHIBIT A HEALTH INSURER FROM4
	539	+	DECREASING COST-SHARING AMOUNTS OR PREMIUMS BY AN AMOUNT5
	540	+	GREATER THAN THE AMOUNT REQUIRED IN SUBSECTION (2) OR (3) OF THIS6
	541	+	SECTION.7
	542	+	(9) THE REQUIREMENTS OF SUBSECTIONS (2), (3), AND (5) OF THIS8
	543	+	SECTION APPLY TO A SELF-FUNDED HEALTH BENEFIT PLAN AND ITS PLAN9
	544	+	MEMBERS ONLY IF THE ENTITY THAT PROVIDES THE PLAN ELECTS TO BE10
	545	+	SUBJECT TO SUBSECTIONS (2), (3), AND (5) OF THIS SECTION FOR ITS11
	546	+	MEMBERS IN COLORADO.12
	547	+	(10) THE COMMISSIONER SHALL PROMULGATE RULES TO13
	548	+	IMPLEMENT AND ENFORCE THIS SECTION .14
	549	+	SECTION 7. In Colorado Revised Statutes, add 25.5-5-513 as15
	550	+	follows:16
	551	+	25.5-5-513. Pharmacy benefits - prescription drugs - rebates17
	552	+	- analysis. (1) B
	553	+	EGINNING IN 2023, THE STATE DEPARTMENT SHALL , IN18
	554	+	COLLABORATION WITH THE ADMINISTRATOR OF THE ALL -PAYER CLAIMS19
	555	+	DATABASE DESCRIBED IN SECTION 25.5-1-204, CONDUCT AN ANNUAL20
	556	+	ANALYSIS OF THE PRESCRIPTION DRUG REBATES RECEIVED IN THE21
	557	+	PREVIOUS CALENDAR YEAR , BY HEALTH INSURANCE CARRIER AND22
	558	+	PRESCRIPTION DRUG TIER. THE ANALYSIS, USING DATA FROM THE23
	559	+	ALL-PAYERS CLAIM DATABASE AND OTHER SOURCES , MUST BE COMPLETED24
	560	+	ON OR BEFORE MAY 1 OF EACH YEAR.25
654	561		(2) T
655		-	HE STATE DEPARTMENT SHALL MAKE THE ANALYSIS
656		-	CONDUCTED IN SUBSECTION
657		-	(1) OF THIS SECTION AVAILABLE TO THE PUBLIC
658		-	ON AN ANNUAL BASIS
659		-	.
660		-	SECTION 8. Appropriation. (1) For the 2022-23 state fiscal year,
661		-	$252,667 is appropriated to the department of regulatory agencies for use
662		-	by the division of insurance. This appropriation is from the division of
663		-	insurance cash fund created in section 10-1-103 (3), C.R.S. To implement
664		-	this act, the division may use this appropriation as follows:
665		-	(a) $237,972 for personal services, which amount is based on an
666		-	assumption that the division will require an additional 1.7 FTE; and
667		-	(b) $14,695 for operating expenses.
668		-	SECTION 9. Act subject to petition - effective date -
669		-	applicability. (1) This act takes effect at 12:01 a.m. on the day following
670		-	the expiration of the ninety-day period after final adjournment of the
671		-	general assembly; except that, if a referendum petition is filed pursuant to
672		-	section 1 (3) of article V of the state constitution against this act or an item,
673		-	section, or part of this act within such period, then the act, item, section, or
674		-	part will not take effect unless approved by the people at the general
675		-	election to be held in November 2022 and, in such case, will take effect on
676		-	the date of the official declaration of the vote thereon by the governor.
677		-	(2) Section 1 of this act applies to health benefit plans issued or
678		-	renewed on or after January 1, 2023.
679		-	PAGE 14-HOUSE BILL 22-1370 (3) Sections 2 through 6 of this act apply to health benefit plans
680		-	issued or renewed on or after January 1, 2024.
681		-	____________________________ ____________________________
682		-	Alec Garnett Steve Fenberg
683		-	SPEAKER OF THE HOUSE PRESIDENT OF
684		-	OF REPRESENTATIVES THE SENATE
685		-	____________________________ ____________________________
686		-	Robin Jones Cindi L. Markwell
687		-	CHIEF CLERK OF THE HOUSE SECRETARY OF
688		-	OF REPRESENTATIVES THE SENATE
689		-	APPROVED________________________________________
690		-	(Date and Time)
691		-	_________________________________________
692		-	Jared S. Polis
693		-	GOVERNOR OF THE STATE OF COLORADO
694		-	PAGE 15-HOUSE BILL 22-1370
	562	+	HE STATE DEPARTMENT SHALL MAKE THE ANALYSIS26
	563	+	CONDUCTED IN SUBSECTION (1) OF THIS SECTION AVAILABLE TO THE27
	564	+	1370
	565	+	-17- PUBLIC ON AN ANNUAL BASIS.1
	566	+	SECTION 8. Appropriation. (1) For the 2022-23 state fiscal2
	567	+	year, $252,667 is appropriated to the department of regulatory agencies3
	568	+	for use by the division of insurance. This appropriation is from the4
	569	+	division of insurance cash fund created in section 10-1-103 (3), C.R.S. To5
	570	+	implement this act, the division may use this appropriation as follows:6
	571	+	(a) $237,972 for personal services, which amount is based on an7
	572	+	assumption that the division will require an additional 1.7 FTE; and8
	573	+	(b) $14,695 for operating expenses.9
	574	+	10
	575	+	SECTION 9. Act subject to petition - effective date -11
	576	+	applicability. (1) This act takes effect at 12:01 a.m. on the day following12
	577	+	the expiration of the ninety-day period after final adjournment of the13
	578	+	general assembly; except that, if a referendum petition is filed pursuant14
	579	+	to section 1 (3) of article V of the state constitution against this act or an15
	580	+	item, section, or part of this act within such period, then the act, item,16
	581	+	section, or part will not take effect unless approved by the people at the17
	582	+	general election to be held in November 2022 and, in such case, will take18
	583	+	effect on the date of the official declaration of the vote thereon by the19
	584	+	governor.20
	585	+	(2) Section 1 of this act applies to health benefit plans issued or21
	586	+	renewed on or after January 1, 2023.22
	587	+	(3) Sections 2 through 6 of this act apply to health benefit plans23
	588	+	issued or renewed on or after January 1, 2024.24
	589	+	1370
	590	+	-18-