Amendments for HB22-1370

House Journal, April 27
33 HB22-1370 be amended as follows, and as so amended, be referred to
34 the Committee on Appropriations with favorable
35 recommendation:
36
37 Amend printed bill, page 4, line 16, strike "ADVANCE".
38
39 Page 5, line 4, strike "AN ALTERNATIVE TO THE".
40
41 Page 5, strike line 5 and substitute "A THERAPEUTIC EQUIVALENT; AND".
42
43 Page 5, strike lines 20 through 23.
44
45 Page 5, line 24, strike "(b)" and substitute "(a)".
46
47 Page 6, line 1, strike "(c)" and substitute "(b)".
48
49 Page 6, strike lines 8 through 25 and substitute:
50
51 "(c) "MEDICAL NECESSITY" HAS THE SAME MEANING AS SET FORTH
52 IN SECTION 10-16-112.5.".
53
54 Page 6, line 26, strike "(f)" and substitute "(d)".
55
1 Page 7, strike lines 2 through 6 and substitute:
2
3 "(e) "STEP THERAPY" MEANS A PROTOCOL THAT REQUIRES A
4 COVERED PERSON TO USE A PRESCRIPTION DRUG OR SEQUENCE OF
5 PRESCRIPTION DRUGS, OTHER THAN THE DRUG THAT THE COVERED
6 PERSON'S HEALTH-CARE PROVIDER RECOMMENDS FOR THE COVERED
7 PERSON'S TREATMENT, BEFORE THE CARRIER PROVIDES COVERAGE FOR
8 THE RECOMMENDED PRESCRIPTION DRUG.".
9
10 Page 7, line 8, strike "A STEP-THERAPY PROTOCOL," and substitute "STEP
11 THERAPY,".
12
13 Page 7, line 10, after "PROTOCOL" insert "FOR STEP THERAPY".
14
15 Page 7, strike lines 11 through 14 and substitute:
16
17 "(3) A CARRIER, PRIVATE UTILIZATION REVIEW ORGANIZATION, OR
18 PBM SHALL:
19 (a) MAKE THE CLINICAL REVIEW CRITERIA AND THE STEP THERAPY
20 EXEMPTION PROCESS AVAILABLE ON THEIR WEBSITES; AND
21 (b) UPON WRITTEN REQUEST, PROVIDE ALL SPECIFIC CLINICAL
22 REVIEW CRITERIA AND OTHER".
23
24 Page 7, line 17, strike " REQUESTER; AND" and substitute "REQUESTER.".
25
26 Page 7, strike lines 18 through 20.
27
28 Page 7, line 22, strike the second "A".
29
30 Page 7, strike line 23 and substitute "STEP THERAPY IF THE PRESCRIBING
31 PROVIDER SUBMITS JUSTIFICATION AND SUPPORTING CLINICAL
32 DOCUMENTATION, IF NEEDED, THAT STATES:".
33
34 Page 7, line 27, strike "EXPECTED TO BE".
35
36 Page 8, strike lines 11 and 12.
37
38 Renumber succeeding subparagraph accordingly.
39
40 Page 8, line 16, strike "CONSIDERATION." and substitute "CONSIDERATION
41 AFTER UNDERGOING STEP THERAPY OR AFTER HAVING SOUGHT AND
42 RECEIVED A STEP-THERAPY EXCEPTION.".
43
44 Page 8, strike lines 17 through 26 and substitute:
45
46 "(b) (I) EXCEPT AS PROVIDED IN SUBSECTION (4)(b)(II) OF THIS
47 SECTION, A CARRIER, ORGANIZATION, OR PBM SHALL GRANT OR DENY A
48 STEP THERAPY EXCEPTION REQUEST OR AN APPEAL OF A DENIAL OF A
49 REQUEST WITHIN:
50 (A) THREE BUSINESS DAYS AFTER RECEIPT OF THE REQUEST; OR
51 (B) IN CASES WHERE EXIGENT CIRCUMSTANCES EXIST, WITHIN
52 TWENTY-FOUR HOURS AFTER RECEIPT OF THE REQUEST.
53
1 (II) IF A REQUEST FOR A STEP THERAPY EXCEPTION OR AN APPEAL
2 OF A DENIAL OF A REQUEST IS INCOMPLETE OR IF ADDITIONAL CLINICALLY
3 RELEVANT INFORMATION IS REQUIRED, THE CARRIER, ORGANIZATION, OR
4 PBM SHALL NOTIFY THE PRESCRIBING PROVIDER WITHIN SEVENTY-TWO
5 HOURS AFTER SUBMISSION OF THE REQUEST, OR WITHIN TWENTY-FOUR
6 HOURS AFTER THE SUBMISSION OF THE REQUEST IF EXIGENT
7 CIRCUMSTANCES EXIST, THAT THE REQUEST OR APPEAL IS INCOMPLETE OR
8 THAT ADDITIONAL CLINICALLY RELEVANT INFORMATION IS REQUIRED.
9 THE CARRIER, ORGANIZATION, OR PBM MUST SPECIFY THE ADDITIONAL
10 INFORMATION THAT IS REQUIRED IN ORDER TO CONSIDER THE STEP
11 THERAPY EXCEPTION REQUEST OR THE APPEAL OF THE DENIAL OF THE
12 REQUEST PURSUANT TO THE CRITERIA DESCRIBED IN SUBSECTION (4)(a) OF
13 THIS SECTION. ONCE THE REQUESTED INFORMATION IS SUBMITTED TO THE
14 CARRIER, ORGANIZATION, OR PBM, THE APPLICABLE PERIOD TO GRANT OR
15 DENY A STEP THERAPY EXCEPTION REQUEST OR AN APPEAL OF A DENIAL
16 OF A REQUEST, AS SPECIFIED IN SUBSECTION (4)(b)(I) OF THIS SECTION,
17 APPLIES.
18 (III) IF A CARRIER, ORGANIZATION, OR PBM DOES NOT MAKE A
19 DETERMINATION REGARDING THE STEP THERAPY EXCEPTION REQUEST OR
20 THE APPEAL OF THE DENIAL OF THE REQUEST OR DOES NOT MAKE A
21 REQUEST FOR ADDITIONAL OR CLINICALLY RELEVANT INFORMATION
22 WITHIN THE REQUIRED TIME, THE STEP THERAPY EXCEPTION REQUEST OR
23 THE APPEAL OF THE DENIAL OF THE REQUEST IS DEEMED GRANTED.".
24
25 Page 9, line 12, strike "AN AB-RATED" and substitute "A".
26
27 Page 10, line 19, strike ""STEP-THERAPY PROTOCOL"" and substitute
28 ""STEP THERAPY"".
29
145 30 Page 10, line 20, strike "10-16-145 (1)(f)" and substitute "10-16-
31 (1)(e)".
32
33 Page 12, line 6, strike ""STEP-THERAPY PROTOCOL"" and substitute ""STEP
34 THERAPY"".
35
145 36 Page 12, line 7, strike "10-16-145 (1)(f)" and substitute "10-16-
37 (1)(e)".
38
39 Page 12, strike lines 10 through 27.
40
41 Strike pages 13 through 17.
42
43 Page 18, strike lines 1 through 21 and substitute:
44
45 "10-16-155. Prescription drugs - rebates - consumer cost
46 reduction - point of sale - study - report - rules - definitions. (1) AS
47 USED IN THIS SECTION, UNLESS THE CONTEXT OTHERWISE REQUIRES:
48 (a) "DISCOUNT" MEANS PRICE REDUCTIONS OR CONCESSIONS,
49 INCLUDING BASE PRICE CONCESSIONS OR OTHER CONTRACTUAL
50 AGREEMENTS MADE BY A MANUFACTURER OR ITS AFFILIATE, THAT
51 REDUCE PAYMENT OR LIABILITY FOR PRESCRIPTION DRUGS INCLUDING A
52 REDUCTION IN THE TOTAL AMOUNT PAID FOR PRESCRIPTION DRUGS,
53 WITHOUT REGARD TO PERFORMANCE, VOLUME, OR UTILIZATION OF THE
54 DRUGS AND ALL OTHER COMPENSATION THAT REDUCES PAYMENT OR
55 LIABILITY FOR PRESCRIPTION DRUGS. "DISCOUNT" DOES NOT INCLUDE A
1 REBATE.
2 (b) "HEALTH INSURER" MEANS A CARRIER:
3 (I) AS DEFINED IN SECTION 10-16-102 (8); AND
4 (II) AS DEFINED IN SECTION 24-50-603 (2).
5 (c) "MANUFACTURER" HAS THE SAME MEANING AS SET FORTH IN
6 SECTION 10-16-1401 (16).
7 (d) "PRESCRIPTION DRUG" HAS THE SAME MEANING AS SET FORTH
8 IN SECTION 12-280-103 (42); EXCEPT THAT THE TERM INCLUDES ONLY
9 PRESCRIPTION DRUGS THAT ARE INTENDED FOR HUMAN USE.
10 (e) "REBATE" MEANS ALL PRICE CONCESSIONS MADE BY A
11 MANUFACTURER OR ITS AFFILIATE THAT ACCRUE TO A PBM OR ITS
12 HEALTH INSURER CLIENT OR ITS AFFILIATE, INCLUDING CREDITS OR
13 INCENTIVES THAT ARE BASED ON ACTUAL OR ESTIMATED UTILIZATION OF
14 PRESCRIPTION DRUGS; THAT RESULT IN THE PLACEMENT OF A
15 PRESCRIPTION DRUG IN A PREFERRED DRUG LIST OR FORMULARY OR
16 PREFERRED FORMULARY POSITION; OR THAT ARE ASSOCIATED WITH
17 CLAIMS ADMINISTERED ON BEHALF OF AN INSURER CLIENT. "REBATE"
18 ALSO INCLUDES CREDITS, INCENTIVES, REFUNDS, AND ALL OTHER
19 COMPENSATION THAT IS PERFORMANCE-BASED. "REBATE" DOES NOT
20 INCLUDE A DISCOUNT.
21 (2) FOR EACH HEALTH BENEFIT PLAN ISSUED OR RENEWED ON OR
22 AFTER JANUARY 1, 2024, A HEALTH INSURER SHALL ENSURE THAT ONE
23 HUNDRED PERCENT OF DISCOUNTS RECEIVED OR TO BE RECEIVED FROM A
24 MANUFACTURER IN CONNECTION WITH DISPENSING OR ADMINISTERING
25 PRESCRIPTION DRUGS INCLUDED IN THE HEALTH INSURER'S FORMULARY,
26 AS DEMONSTRATED IN THE HEALTH INSURER'S RATE FILING PURSUANT TO
27 SECTION 10-16-107, FOR THAT PLAN YEAR ARE USED TO REDUCE COSTS.
28 (3) FOR EACH HEALTH BENEFIT PLAN ISSUED OR RENEWED ON OR
29 AFTER JANUARY 1, 2024, A HEALTH INSURER SHALL ENSURE THAT:
30 (a) ONE HUNDRED PERCENT OF THE ESTIMATED REBATES RECEIVED
31 OR TO BE RECEIVED IN CONNECTION WITH DISPENSING OR ADMINISTERING
32 PRESCRIPTION DRUGS INCLUDED IN THE HEALTH INSURER'S FORMULARY
33 FOR THAT PLAN YEAR ARE USED TO REDUCE POLICYHOLDER COSTS;
34 (b) FOR SMALL GROUP AND LARGE GROUP HEALTH BENEFIT PLANS,
35 ALL REBATES ARE USED TO REDUCE EMPLOYER OR INDIVIDUAL EMPLOYEE
36 COSTS; AND
37 (c) FOR INDIVIDUAL HEALTH BENEFIT PLANS, ALL REBATES ARE
38 USED TO REDUCE CONSUMER PREMIUMS AND OUT-OF-POCKET COSTS FOR
39 PRESCRIPTION DRUGS AND THAT HEALTH INSURERS WILL MAXIMIZE THE
40 USE OF REBATES TO REDUCE CONSUMER OUT-OF-POCKET COSTS AT THE
41 POINT OF SALE NOT TO EXCEED THE CONSUMER'S ACTUAL OUT-OF-POCKET
42 COSTS FOR THE PRESCRIPTION DRUG IF THE USE OF SUCH REBATES WILL
43 NOT:
44 (I) INCREASE PREMIUMS;
45 (II) CHANGE THE ACTUARIAL VALUE OF THE PLAN INCONSISTENT
46 WITH FEDERAL AND STATE REQUIREMENTS; OR
47 (III) OTHERWISE RESULT IN AN IMPACT THAT IS NOT IN THE BEST
48 INTEREST OF CONSUMERS.
49 (4) (a) ON OR BEFORE JUNE 1, 2023, THE DIVISION SHALL CONDUCT
50 AND COMPLETE A STUDY TO EVALUATE HOW REBATES MAY BE APPLIED IN
51 THE INDIVIDUAL MARKET TO REDUCE A COVERED PERSON'S
52 OUT-OF-POCKET COSTS AT THE POINT OF SALE OR TO REDUCE
53 OUT-OF-POCKET COSTS IN PRESCRIPTION DRUG TIERS, TAKING INTO
54 CONSIDERATION THE FOLLOWING FACTORS:
55 (I) PREMIUM IMPACTS;
1 (II) CHANGES IN THE PLAN'S ACTUARIAL VALUE; AND
2 (III) OTHER POTENTIAL IMPACTS TO CONSUMERS.
3 (b) REGARDLESS OF THE RESULTS OF THE STUDY, A HEALTH
4 INSURER SHALL COMPLY WITH SUBSECTION (3) OF THIS SECTION.
5 (c) THE DIVISION MAY CONTRACT WITH A THIRD PARTY TO
6 CONDUCT THE STUDY REQUIRED BY THIS SUBSECTION (4). THE
7 COMMISSIONER IS NOT REQUIRED TO COMPLY WITH THE "PROCUREMENT
8 CODE", ARTICLES 101 TO 112 OF TITLE 24, FOR THE PURPOSES OF THIS
9 SECTION, BUT SHALL ENSURE A COMPETITIVE PROCESS IS USED TO SELECT
10 A THIRD PARTY TO CONDUCT THE STUDY.
11 (5) EACH HEALTH INSURER SHALL REPORT ANNUALLY:
12 (a) IN A FORM AND MANNER DETERMINED BY THE COMMISSIONER,
13 DATA DEMONSTRATING THAT ALL DISCOUNTS AND REBATES RECEIVED BY
14 HEALTH INSURERS ARE USED TO REDUCE COSTS FOR POLICYHOLDERS IN
15 COMPLIANCE WITH THIS SECTION. THE COMMISSIONER MAY USE DISCOUNT
16 AND REBATE DATA SUBMITTED BY HEALTH INSURERS TO THE ALL-PAYER
17 HEALTH CLAIMS DATABASE DESCRIBED IN SECTION 25.5-1-204 TO THE
18 EXTENT SUCH DATA ARE AVAILABLE FROM THE ALL-PAYER HEALTH
19 CLAIMS DATABASE.
20 (b) AN ACTUARIAL CERTIFICATION THAT ATTESTS THAT:
21 (I) THE HEALTH INSURER AND PBM ARE IN COMPLIANCE WITH
22 SUBSECTIONS (2) AND (3) OF THIS SECTION; AND
23 (II) THE DATA REPORTED AS REQUIRED BY THIS SECTION ARE
24 ACCURATE.
25 (6) THE DIVISION MAY USE DATA FROM THE DEPARTMENT OF
26 HEALTH CARE POLICY AND FINANCING, THE ALL-PAYER HEALTH CLAIMS
27 DATABASE DESCRIBED IN SECTION 25.5-1-204, AND OTHER SOURCES TO
28 VERIFY THAT A HEALTH INSURER AND PBM ARE IN COMPLIANCE WITH
29 THIS SECTION.
30 (7) INFORMATION SUBMITTED BY THE HEALTH INSURERS AND
31 PBMS TO THE DIVISION IN ACCORDANCE WITH THIS SECTION IS SUBJECT
32 TO PUBLIC INSPECTION ONLY TO THE EXTENT ALLOWED UNDER THE
33 "COLORADO OPEN RECORDS ACT", PART 2 OF ARTICLE 72 OF TITLE 24,
34 AND IN NO CASE SHALL TRADE-SECRET, CONFIDENTIAL, OR PROPRIETARY
35 INFORMATION BE DISCLOSED TO ANY PERSON WHO IS NOT OTHERWISE
36 AUTHORIZED TO ACCESS SUCH INFORMATION.
37 (8) THIS SECTION DOES NOT PROHIBIT A HEALTH INSURER FROM
38 DECREASING COST-SHARING AMOUNTS OR PREMIUMS BY AN AMOUNT
39 GREATER THAN THE AMOUNT REQUIRED IN SUBSECTION (2) OR (3) OF THIS
40 SECTION.
41 (9) THE REQUIREMENTS OF SUBSECTIONS (2), (3), AND (5) OF THIS
42 SECTION APPLY TO A SELF-FUNDED HEALTH BENEFIT PLAN AND ITS PLAN
43 MEMBERS ONLY IF THE ENTITY THAT PROVIDES THE PLAN ELECTS TO BE
44 SUBJECT TO SUBSECTIONS (2), (3), AND (5) OF THIS SECTION FOR ITS
45 MEMBERS IN COLORADO.
46 (10) THE COMMISSIONER SHALL PROMULGATE RULES TO
47 IMPLEMENT AND ENFORCE THIS SECTION.".
48
49 Strike "BRAND-NAME" on: Page 4, lines 24 and 26; and Page 5, line 1.
50
51 Strike "PROTOCOL" on: Page 8, line 27; and Page 9, lines 8, 15, and 17.
52
53 Strike "A step-therapy PROTOCOL" and substitute "step-therapy STEP
54 THERAPY" on: Page 10, lines 8 and 9; and Page 11, lines 3 and 4, 16 and
55 17, and 19.
1 JUDICIARY
2 After consideration on the merits, the Committee recommends the
3 following:
4

House Journal, April 29
45 HB22-1370 be amended as follows, and as so amended, be referred to
46 the Committee of the Whole with favorable
47 recommendation:
48
49 Amend printed bill, page 19, after line 8 insert:
50
51
1 "SECTION 8. Appropriation. (1) For the 2022-23 state fiscal
2 year, $252,667 is appropriated to the department of regulatory agencies
3 for use by the division of insurance. This appropriation is from the
4 division of insurance cash fund created in section 10-1-103 (3), C.R.S. To
5 implement this act, the division may use this appropriation as follows:
6 (a) $237,972 for personal services, which amount is based on an
7 assumption that the division will require an additional 1.7 FTE; and
8 (b) $14,695 for operating expenses.
9 (2) For the 2022-23 state fiscal year, $91,809 is appropriated to
10 the department of health care policy and financing for use by the
11 executive director's office. This appropriation is from the general fund.
12 To implement this act, the office may use this appropriation for the all-
13 payer claims database.".
14
15 Renumber succeeding section accordingly.
16
17 Page 1, line 102, strike "PRODUCTS." and substitute "PRODUCTS, AND, IN
18 CONNECTION THEREWITH, MAKING AN APPROPRIATION.".
19
20

House Journal, April 29
41 Amendment No. 1, Appropriations Report, dated April 29, 2022, and
42 placed in member’s bill file; Report also printed in House Journal,
43 April 29, 2022.
44
45 Amendment No. 2, Health & Insurance Report, dated April 27, 2022, and
46 placed in member’s bill file; Report also printed in House Journal,
47 April 27, 2022.
48
49 Amendment No. 3, by Representative Jodeh.
50
51 Amend the Health and Insurance Committee Report, dated April 27,
52 2022, page 1, line 4, strike "23." and substitute "23 and substitute:
53 "(a) "BIOSIMILAR" HAS THE MEANING SET FORTH IN 42 U.S.C. SEC.
54 262 (i)(2).".".
55
1 Page 1, strike lines 5 and 6.
2
3 Page 1, strike line 8 and substitute:
4
5 ""(d) "EXIGENT CIRCUMSTANCE" MEANS A CIRCUMSTANCE IN
6 WHICH A COVERED PERSON IS SUFFERING FROM A HEALTH CONDITION THAT
7 MAY SERIOUSLY JEOPARDIZE THE COVERED PERSON'S LIFE, HEALTH, OR
8 ABILITY TO REGAIN MAXIMUM FUNCTIONS.
9 (e) "MEDICAL NECESSITY" HAS THE SAME MEANING AS SET
10 FORTH".
11
12 Page 1, strike line 10.
13
14 Page 1, line 12, strike ""(e)" and substitute ""(g)".
15
16 Page 3, strike line 28 and substitute "(1)(g)".".
17
18 Page 3, strike line 32 and substitute "(1)(g)".".
19
20 Amendment No. 4, by Representative Jodeh.
21
22 Amend the Health and Insurance Committee Report, page 3, strike line
23 24 and substitute:
24
25 "Page 9 of the printed bill, strike line 12 and substitute "COVERED PERSON
26 TO TRY A GENERIC EQUIVALENT DRUG, A BIOSIMILAR DRUG, OR AN".".
27
28 Amendment No. 5, by Representative Jodeh.
29
30 Amend the Health and Insurance Committee Report, dated April 27,
31 2022, page 4, line 23, strike "CLIENT OR ITS AFFILIATE," and substitute
32 "CLIENT,".
33
34 Amendment No. 6, by Representative Jodeh.
35
36 Amend printed bill, page 4, line 5, strike "CARRIER," and substitute
37 "CARRIER IN THE INDIVIDUAL MARKET,".
38
39 Page 4, line 12, after "PLAN" insert "ON THE INDIVIDUAL MARKET".
40
41 Page 4, line 23, strike "OR".
42
43 Page 5, line 3, after "DRUG" insert "OR BIOSIMILAR DRUG".
44
45 Page 5, line 7, after "DRUG" insert "OR BIOSIMILAR DRUG".
46
47 Page 5, line 10, strike "MOVED." and substitute "MOVED; OR
48 (c) REMOVE A PRESCRIPTION DRUG FROM THE PRESCRIPTION DRUG
49 FORMULARY OR LIST OF COVERED DRUGS, OR MOVE A PRESCRIPTION DRUG
50 TO A HIGHER COST SHARING TIER, WITH ADVANCE NOTICE TO A COVERED
51 PERSON AND THE COVERED PERSON'S PROVIDER, IF:
52 (I) THE PRESCRIPTION DRUG HAS A WHOLESALE ACQUISITION COST
53 GREATER THAN FIVE HUNDRED DOLLARS AT THE START OF THE BENEFIT
54 YEAR AND THE CARRIER'S NET COST INCREASES BY FIFTEEN PERCENT OR
55 MORE DURING THAT BENEFIT YEAR; AND
1 (II) THE PRESCRIPTION DRUG WILL BE REPLACED ON THE
2 FORMULARY WITH A THERAPEUTICALLY EQUIVALENT GENERIC OR
3 MULTI-SOURCE BRAND NAME DRUG, AN INTERCHANGEABLE BIOLOGIC, OR
4 BIOSIMILAR DRUG AT A LOWER COST TO THE ENROLLEE.
5 (d) PRIOR TO REMOVING A DRUG FROM A FORMULARY PURSUANT
6 TO THIS SECTION, THE CARRIER MUST ATTEST AND DEMONSTRATE TO THE
7 DIVISION, IN A FORM AND MANNER DETERMINED BY THE COMMISSIONER BY
8 RULE, THAT IT HAS COMPLIED WITH THE REQUIREMENTS OF THIS SECTION
9 AND HAS PROVIDED ADVANCED NOTICE TO ITS ENROLLEES.".
10
11 As amended, ordered engrossed and placed on the Calendar for Third
12 Reading and Final Passage.
13