Second Regular Session
Seventy-third General Assembly
STATE OF COLORADO
REVISED
This Version Includes All Amendments Adopted
on Second Reading in the Second House
LLS NO. 22-0251.01 Kristen Forrestal x4217
HOUSE BILL 22-1370
House Committees Senate Committees
Health & Insurance State, Veterans, & Military Affairs
Appropriations Appropriations
A BILL FOR AN ACT
C
ONCERNING COVERAGE REQUIREMENTS FOR HEALTH -CARE101
PRODUCTS, AND, IN CONNECTION THEREWITH, MAKING AN102
APPROPRIATION.103
Bill Summary
(Note: This summary applies to this bill as introduced and does
not reflect any amendments that may be subsequently adopted. If this bill
passes third reading in the house of introduction, a bill summary that
applies to the reengrossed version of this bill will be available at
http://leg.colorado.gov
.)
Beginning in 2023, the bill requires each health insurance carrier
(carrier) that offers an individual or small group health benefit plan in this
state to offer at least 25% of its health benefit plans on the Colorado
health benefit exchange (exchange) and at least 25% of its plans not on
the exchange in each bronze, silver, gold, and platinum benefit level in
SENATE
Amended 2nd Reading
May 6, 2022
HOUSE
3rd Reading Unamended
May 2, 2022
HOUSE
Amended 2nd Reading
April 29, 2022
HOUSE SPONSORSHIP
Jodeh and Sirota, Amabile, Bacon, Bernett, Boesenecker, Caraveo, Cutter, Duran,
Froelich, Gonzales-Gutierrez, Gray, Hooton, Kennedy, Kipp, Lindsay, Michaelson Jenet,
Ortiz, Sullivan, Weissman, Will, Woodrow, Young, Esgar, Exum, Garnett, Herod, Lontine,
McCormick, McLachlan, Ricks, Titone, Valdez D.
SENATE SPONSORSHIP
Winter and Buckner,
Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment.
Capital letters or bold & italic numbers indicate new material to be added to existing statute.
Dashes through the words indicate deletions from existing statute. each service area as copayment-only payment structures for all
prescription drug cost tiers.
Starting in 2024, a carrier or, if a carrier uses a pharmacy benefit
manager (PBM) for claims processing services or other prescription drug
or device services under a health benefit plan offered by the carrier, the
PBM, or a representative of the carrier or the PBM, is prohibited from
modifying or applying a modification to the current prescription drug
formulary during the current plan year.
The bill repeals and reenacts the current requirements for step
therapy and requires a carrier to use clinical review criteria to establish
the step-therapy protocol.
For each health benefit plan issued or renewed on or after January
1, 2024, the bill requires each carrier or PBM to demonstrate to the
division of insurance that:
! 100% of the estimated rebates received or to be received in
connection with dispensing or administering prescription
drugs included in the carrier's prescription drug formulary
are used to reduce costs for the employer or individual
purchasing the plan;
! For small group and large employer health benefit plans, all
rebates are used to reduce employer and individual
employee costs; and
! For individual health benefit plans, all rebates are used to
reduce consumers' premiums and out-of-pocket costs for
prescription drugs to the extent practicable.
The bill requires the commissioner of insurance (commissioner)
to promulgate rules to implement prescription drug pass-through
requirements for carriers. Each carrier or PBM is required to report
annually specified prescription drug rebate information to the
commissioner.
Beginning in 2023, the bill requires the department of health care
policy and financing, in collaboration with the administrator of the
all-payer claims database, to conduct an annual analysis of the
prescription drug rebates received in the previous calendar year, by carrier
and prescription drug tier, and make the analysis available to the public.
Be it enacted by the General Assembly of the State of Colorado:1
SECTION 1. In Colorado Revised Statutes, add 10-16-103.6 as2
follows:3
10-16-103.6. Copayment-only prescription payment structures4
- required inclusion in health benefit plans - rules. (1) (a) (I) I
N5
1370-2- ADDITION TO THE REQUIREMENTS IN SECTION 10-16-103.4 (2), FOR HEALTH1
BENEFIT PLANS ISSUED OR RENEWED ON OR AFTER JANUARY 1, 2023, EACH2
CARRIER THAT OFFERS AN INDIVIDUAL OR SMALL GROUP HEALTH BENEFIT3
PLAN SHALL OFFER AT LEAST TWENTY -FIVE PERCENT OF ITS HEALTH4
BENEFIT PLANS ON THE EXCHANGE AND AT LEAST TWENTY -FIVE PERCENT5
OF ITS PLANS NOT ON THE EXCHANGE IN EACH BRONZE , SILVER, GOLD, AND6
PLATINUM BENEFIT LEVEL IN EACH SERVICE AREA AS COPAYMENT -ONLY7
PAYMENT STRUCTURES FOR ALL PRESCRIPTION DRUG COST TIERS .8
(b) F
OR EACH COPAYMENT -ONLY PAYMENT STRUCTURE FOR9
PRESCRIPTIONS DRUGS:10
(I) T
HE COPAYMENT AMOUNT FOR THE HIGHEST PRESCRIPTION11
DRUG COST TIER MUST NOT BE GREATER THAN ONE -TWELFTH OF THE12
HEALTH BENEFIT PLAN'S OUT-OF-POCKET MAXIMUM AMOUNT ;13
(II) T
HE COPAYMENT AMOUNTS BETWEEN THE TWO HIGHEST14
PRESCRIPTION DRUG COST TIERS MUST HAVE A COST DIFFERENCE OF AT15
LEAST TEN PERCENT;16
(III) N
O MORE THAN FIFTY PERCENT OF THE DRUGS ON THE17
PRESCRIPTION DRUG FORMULARY USED TO TREAT A SPECIFIC CONDITION18
MAY BE PLACED ON THE HIGHEST PRESCRIPTION DRUG COST TIER ; AND19
(IV) E
ACH CARRIER SHALL USE "RX COPAY" AT THE END OF THE20
MARKETING NAMES FOR EACH COPAYMENT -ONLY PAYMENT STRUCTURE .21
(2) T
HE COMMISSIONER MAY PROMULGATE RULES TO IMPLEMENT22
AND ENFORCE THIS SECTION.23
SECTION 2. In Colorado Revised Statutes, add 10-16-122.4 as24
follows:25
10-16-122.4. Pharmacy benefits - formulary change26
prohibition - exceptions - definition - rules. (1) (a) S
TARTING IN 2024,27
1370
-3- EXCEPT AS PROVIDED IN SUBSECTION (2) OF THIS SECTION, A CARRIER OR,1
IF A CARRIER USES A PBM FOR CLAIMS PROCESSING SERVICES OR OTHER2
PRESCRIPTION DRUG OR DEVICE SERVICES, AS THOSE TERMS ARE DEFINED3
IN SECTION 10-16-122.1, UNDER A HEALTH BENEFIT PLAN OFFERED BY THE4
CARRIER IN THE INDIVIDUAL MARKET, THE PBM, OR A REPRESENTATIVE5
OF THE CARRIER OR THE PBM, SHALL NOT MODIFY OR APPLY A6
MODIFICATION TO THE CURRENT PRESCRIPTION DRUG FORMULARY DURING7
THE CURRENT PLAN YEAR.8
(b) A
S USED IN THIS SUBSECTION (1), "MODIFY" OR9
"
MODIFICATION" INCLUDES ELIMINATING A PARTICULAR PRESCRIPTION10
DRUG FROM THE FORMULARY OR M OVING A PRESCRIPTION DRUG TO A11
HIGHER COST-SHARING TIER.12
(2) A
CARRIER OFFERING A HEALTH BENEFIT PLAN
ON THE13
INDIVIDUAL MARKET IN THIS STATE THAT INCLUDES A PRESCRIPTION DRUG14
BENEFIT AND USES A PRESCRIPTION DRUG FORMULARY OR LIST OF15
COVERED DRUGS MAY:16
(a) R
EMOVE A PRESCRIPTION DRUG FROM THE PRESCRIPTION DRUG17
FORMULARY OR LIST OF COVERED DRUGS , WITH
NOTICE TO A COVERED18
PERSON AND THE COVERED PERSON 'S PROVIDER, IF:19
(I) T
HE FDA ISSUES AN ANNOUNCEMENT , GUIDANCE, NOTICE,20
WARNING, OR STATEMENT CONCERNING THE PRESCRIPTION DRUG THAT21
CALLS INTO QUESTION THE CLINICAL SAFETY OF THE PRESCRIPTION DRUG ;22
OR23
(II) T
HE PRESCRIPTION DRUG IS APPROVED BY THE FDA FOR USE24
WITHOUT A PRESCRIPTION;
25
(b) M
OVE A
PRESCRIPTION DRUG FROM A PRESCRIPTION DRUG26
COST-SHARING TIER THAT IMPOSES A LESSER COPAYMENT OR DEDUCTIBLE27
1370
-4- FOR THE PRESCRIPTION DRUG TO A COST-SHARING TIER THAT IMPOSES1
A GREATER COPAYMENT OR DEDUCTIBLE FOR THE PRESCRIPTION DRUG2
IF THE CARRIER ADDS TO THE PRESCRIPTION DRUG FORMULARY OR LIST OF3
COVERED DRUGS A GENERIC PRESCRIPTION DRUG OR BIOSIMILAR DRUG4
THAT IS:5
(I) A
PPROVED BY THE FDA FOR USE AS
A THERAPEUTIC6
EQUIVALENT; AND7
(II) I
N A PRESCRIPTION DRUG COST-SHARING TIER THAT IMPOSES8
A COPAYMENT OR DEDUCTIBLE FOR THE GENERIC PRESCRIPTION DRUG
OR9
BIOSIMILAR DRUG THAT IS LESS THAN THE COPAYMENT OR DEDUCTIBLE10
THAT IS IMPOSED FOR THE BRAND -NAME PRESCRIPTION DRUG IN THE11
COST-SHARING TIER TO WHICH THE BRAND -NAME PRESCRIPTION DRUG IS12
MOVED; OR13
(c) REMOVE A PRESCRIPTION DRUG FROM THE PRESCRIPTION DRUG14
FORMULARY OR LIST OF COVERED DRUGS, OR MOVE A PRESCRIPTION DRUG15
TO A HIGHER COST SHARING TIER, WITH ADVANCE NOTICE TO A COVERED16
PERSON AND THE COVERED PERSON 'S PROVIDER, IF:17
(I) THE PRESCRIPTION DRUG HAS A WHOLESALE ACQUISITION COST18
GREATER THAN FIVE HUNDRED DOLLARS AT THE START OF THE BENEFIT19
YEAR AND THE CARRIER'S NET COST INCREASES BY FIFTEEN PERCENT OR20
MORE DURING THAT BENEFIT YEAR ; AND21
(II) THE PRESCRIPTION DRUG WILL BE REPLACED ON THE22
FORMULARY WITH A THERAPEUTICALLY EQUIVALENT GENERIC OR23
MULTI-SOURCE BRAND NAME DRUG, AN INTERCHANGEABLE BIOLOGIC, OR24
BIOSIMILAR DRUG AT A LOWER COST TO THE ENROLLEE .25
(d) PRIOR TO REMOVING A DRUG FROM A FORMULARY PURSUANT26
TO THIS SECTION, THE CARRIER MUST ATTEST AND DEMONSTRATE TO THE27
1370
-5- DIVISION, IN A FORM AND MANNER DETERMINED BY THE COMMISSIONER BY1
RULE, THAT IT HAS COMPLIED WITH THE REQUIREMENTS OF THIS SECTION2
AND HAS PROVIDED ADVANCED NOTICE TO ITS ENROLLEES .3
(3) T
HIS SECTION DOES NOT PROHIBIT A CARRIER FROM ADDING A4
PRESCRIPTION DRUG TO A PRESCRIPTION DRUG FORMULARY OR LIST OF5
COVERED DRUGS AT ANY TIME .6
(4) T
HE COMMISSIONER MAY PROMULGATE RULES TO IMPLEMENT7
AND ENFORCE THIS SECTION.8
SECTION 3. In Colorado Revised Statutes, repeal and reenact,9
with amendments, 10-16-145 as follows:10
10-16-145. Step-therapy protocol - limitations - exceptions -11
definitions - rules. (1) A
S USED IN THIS SECTION:12
(a) "BIOSIMILAR" HAS THE MEANING SET FORTH IN 42 U.S.C. SEC.13
262 (i)(2).14
(b) "C
LINICAL PRACTICE GUIDELINES" MEANS A SYSTEMATICALLY15
DEVELOPED STATEMENT TO ASSIST PROVIDERS AND COVERED PERSONS IN16
MAKING DECISIONS ABOUT APPROPRIATE HEALTH CARE FOR SPECIFIC17
CLINICAL CIRCUMSTANCES AND CONDITIONS .18
(c) "C
LINICAL REVIEW CRITERIA" MEANS THE WRITTEN SCREENING19
PROCEDURES, DECISION ABSTRACTS, CLINICAL PROTOCOLS, AND CLINICAL20
PRACTICE GUIDELINES USED BY A CARRIER OR PRIVATE UTILIZATION21
REVIEW ORGANIZATION TO DETERMINE THE MEDICAL NECESSITY AND22
APPROPRIATENESS OF THE PROVISION OF HEALTH -CARE SERVICES.23
C
LINICAL REVIEW CRITERIA MUST NOT BE MORE RESTRICTIVE THAN THE24
FDA'
S INDICATION FOR A SPECIFIC DRUG OR HEALTH- CARE SERVICE.25
(d) "EXIGENT CIRCUMSTANCE" MEANS A CIRCUMSTANCE IN WHICH26
A COVERED PERSON IS SUFFERING FROM A HEALTH CONDITION THAT MAY27
1370
-6- SERIOUSLY JEOPARDIZE THE COVERED PERSON'S LIFE, HEALTH, OR ABILITY1
TO REGAIN MAXIMUM FUNCTIONS .2
(e) "MEDICAL NECESSITY" HAS THE SAME MEANING AS SET FORTH3
IN SECTION 10-16-112.5.4
(f) "P
RIVATE UTILIZATION REVIEW ORGANIZATION " OR5
"
ORGANIZATION" HAS THE SAME MEANING AS SET FORTH IN SECTION6
10-16-112 (1)(a).7
(g) "STEP THERAPY" MEANS A PROTOCOL THAT REQUIRES A8
COVERED PERSON TO USE A PRESCRIPTION DRUG OR SEQUENCE OF9
PRESCRIPTION DRUGS, OTHER THAN THE DRUG THAT THE COVERED10
PERSON'S HEALTH-CARE PROVIDER RECOMMENDS FOR THE COVERED11
PERSON'S TREATMENT, BEFORE THE CARRIER PROVIDES COVERAGE FOR12
THE RECOMMENDED PRESCRIPTION DRUG .13
(2) I
F A CARRIER, A PRIVATE UTILIZATION REVIEW ORGANIZATION ,14
OR A PBM REQUIRES
STEP THERAPY, THE CARRIER, ORGANIZATION, OR15
PBM
SHALL USE CLINICAL REVIEW CRITERIA TO ESTABLISH THE PROTOCOL16FOR STEP THERAPY BASED ON CLINICAL PRACTICE GUIDELINES .17
(3) A CARRIER, PRIVATE UTILIZATION REVIEW ORGANIZATION, OR18
PBM SHALL:19
(a) MAKE THE CLINICAL REVIEW CRITERIA AND THE STEP THERAPY20
EXEMPTION PROCESS AVAILABLE ON THEIR WEBSITES ; AND21
(b) UPON WRITTEN REQUEST, PROVIDE ALL SPECIFIC CLINICAL22
REVIEW CRITERIA AND OTHER CLINICAL INFORMATION RELATING TO A23
COVERED PERSON'S PARTICULAR CONDITION OR DISEASE , INCLUDING24
CLINICAL REVIEW CRITERIA RELATING TO A STEP-THERAPY EXCEPTION, TO25
THE REQUESTER.26
27
1370
-7- (4) (a) A CARRIER, A PRIVATE UTILIZATION REVIEW1
ORGANIZATION, OR A PBM SHALL GRANT AN EXCEPTION TO STEP2
THERAPY IF THE PRESCRIBING PROVIDER SUBMITS JUSTIFICATION AND3
SUPPORTING CLINICAL DOCUMENTATION , IF NEEDED, THAT STATES:4
(I) T
HE PROVIDER ATTESTS THAT THE
REQUIRED PRESCRIPTION5
DRUG IS CONTRAINDICATED OR WILL LIKELY CAUSE AN ADVERSE REACTION6
OR HARM TO THE COVERED PERSON ;7
(II) T
HE REQUIRED PRESCRIPTION DRUG IS
INEFFECTIVE BASED8
ON THE KNOWN CLINICAL CHARACTERISTICS OF THE COVERED PERSON AND9
THE KNOWN CHARACTERISTICS OF THE PRESCRIPTION DRUG REGIMEN ;10
(III) T
HE COVERED PERSON HAS TRIED , WHILE UNDER THE11
COVERED PERSON'S CURRENT OR PREVIOUS HEALTH BENEFIT PLAN , THE12
REQUIRED PRESCRIPTION DRUG OR ANOTHER PRESCRIPTION DRUG IN THE13
SAME PHARMACOLOGIC CLASS OR WITH THE SAME MECHANISM OF ACTION ,14
AND THE USE OF THE PRESCRIPTION DRUG BY THE COVERED PERSON WAS15
DISCONTINUED DUE TO LACK OF EFFICACY OR EFFECTIVENESS , DIMINISHED16
EFFECT, OR AN ADVERSE EVENT;17 18
(IV) THE COVERED PERSON, WHILE ON THE COVERED PERSON 'S19
CURRENT OR PREVIOUS HEALTH BENEFIT PLAN , IS STABLE ON A20
PRESCRIPTION DRUG SELECTED BY THE PRESCRIBING PROVIDER FOR THE21
MEDICAL CONDITION UNDER CONSIDERATION AFTER UNDERGOING STEP22
THERAPY OR AFTER HAVING SOUGHT AND RECEIVED A STEP-THERAPY23
EXCEPTION.24
(b) (I) EXCEPT AS PROVIDED IN SUBSECTION (4)(b)(II) OF THIS25
SECTION, A CARRIER, ORGANIZATION, OR PBM SHALL GRANT OR DENY A26
STEP THERAPY EXCEPTION REQUEST OR AN APPEAL OF A DENIAL OF A27
1370
-8- REQUEST WITHIN:1
(A) THREE BUSINESS DAYS AFTER RECEIPT OF THE REQUEST ; OR2
(B) IN CASES WHERE EXIGENT CIRCUMSTANCES EXIST , WITHIN3
TWENTY-FOUR HOURS AFTER RECEIPT OF THE REQUEST .4
(II) IF A REQUEST FOR A STEP THERAPY EXCEPTION OR AN APPEAL5
OF A DENIAL OF A REQUEST IS INCOMPLETE OR IF ADDITIONAL CLINICALLY6
RELEVANT INFORMATION IS REQUIRED, THE CARRIER, ORGANIZATION, OR7
PBM SHALL NOTIFY THE PRESCRIBING PROVIDER WITHIN SEVENTY-TWO8
HOURS AFTER SUBMISSION OF THE REQUEST, OR WITHIN TWENTY-FOUR9
HOURS AFTER THE SUBMISSION OF THE REQUEST IF EXIGENT10
CIRCUMSTANCES EXIST, THAT THE REQUEST OR APPEAL IS INCOMPLETE OR11
THAT ADDITIONAL CLINICALLY RELE VANT INFORMATION IS REQUIRED. THE12
CARRIER, ORGANIZATION, OR PBM MUST SPECIFY THE ADDITIONAL13
INFORMATION THAT IS REQUIRED IN ORDER TO CONSIDER THE STEP14
THERAPY EXCEPTION REQUEST OR THE APPEAL OF THE DENIAL OF THE15
REQUEST PURSUANT TO THE CRITERIA DESCRIBED IN SUBSECTION (4)(a) OF16
THIS SECTION. ONCE THE REQUESTED INFORMATION IS SUBMITTED TO THE17
CARRIER, ORGANIZATION, OR PBM, THE APPLICABLE PERIOD TO GRANT OR18
DENY A STEP THERAPY EXCEPTION REQUEST OR AN APPEAL OF A DENIAL OF19
A REQUEST, AS SPECIFIED IN SUBSECTION (4)(b)(I) OF THIS SECTION,20
APPLIES.21
(III) IF A CARRIER, ORGANIZATION, OR PBM DOES NOT MAKE A22
DETERMINATION REGARDING THE STEP THERAPY EXCEPTION REQUEST OR23
THE APPEAL OF THE DENIAL OF THE REQUEST OR DOES NOT MAKE A24
REQUEST FOR ADDITIONAL OR CLINICALLY RELEVANT INFORMATION25
WITHIN THE REQUIRED TIME, THE STEP THERAPY EXCEPTION REQUEST OR26
THE APPEAL OF THE DENIAL OF THE REQUEST IS DEEMED GRANTED .27
1370
-9- (c) IF THE INITIAL REQUEST FOR A STEP-THERAPY EXCEPTION IS1
DENIED, THE CARRIER, ORGANIZATION, OR PBM SHALL INFORM THE2
COVERED PERSON IN WRITING THAT THE COVERED PERSON HAS THE RIGHT3
TO AN INTERNAL OR EXTERNAL REVIEW OR AN APPEAL OF THE ADVERSE4
DETERMINATION PURSUANT TO SECTIONS 10-16-113 AND 10-16-113.5.5
(d) A
CARRIER, AN ORGANIZATION, OR A PBM SHALL AUTHORIZE6
COVERAGE FOR THE PRESCRIPTION DRUG PRESCRIBED BY THE COVERED7
PERSON'S PRESCRIBING PROVIDER WHEN THE STEP-THERAPY
EXCEPTION8
REQUEST IS GRANTED.9
(5) T
HIS SECTION DOES NOT PROHIBIT:10
(a) A
CARRIER, AN ORGANIZATION, OR A PBM FROM REQUIRING A11
COVERED PERSON TO TRY A GENERIC EQUIVALENT DRUG , A BIOSIMILAR12
DRUG, OR AN INTERCHANGEABLE BIOLOGICAL PRODUCT AS DEFINED BY 4213
U.S.C.
SEC. 262 (i)(3), UNLESS THE COVERED PERSON OR COVERED14
PERSON'S PRESCRIBING PROVIDER HAS REQUESTED A STEP -THERAPY
15
EXCEPTION AND THE PRESCRIBED DRUG MEETS THE CRITERIA FOR A16
STEP-THERAPY EXCEPTION SPECIFIED IN SUBSECTION (4)(a) OF THIS17
SECTION;18
(b) A
CARRIER, AN ORGANIZATION, OR A PBM FROM REQUIRING A19
PHARMACIST TO MAKE SUBSTITUTIONS OF PRESCRIPTION DRUGS20
CONSISTENT WITH PART 5 OF ARTICLE 280 OF TITLE 12; OR21
(c) A
PROVIDER FROM PRESCRIBING A DRUG THAT IS DETERMINED22
TO BE MEDICALLY APPROPRIATE.23
(6) T
HE COMMISSIONER MAY PROMULGATE RULES TO IMPLEMENT24
AND ENFORCE THIS SECTION.25
SECTION 4. In Colorado Revised Statutes, amend as it exists26
until January 1, 2023, 10-16-145.5 as follows:27
1370
-10- 10-16-145.5. Step therapy prohibited - stage four advanced1
metastatic cancer - definitions. (1) Notwithstanding section 10-16-145,2
a carrier that provides coverage under a health benefit plan for the3
treatment of stage four advanced metastatic cancer shall not limit or4
exclude coverage under the health benefit plan for a drug approved by the5
United States food and drug administration FDA and that is on the6
carrier's prescription drug formulary by mandating that a covered person7
with stage four advanced metastatic cancer undergo step-therapy STEP8
THERAPY if the use of the approved drug is consistent with:9
(a) The United States food and drug administration-approved10
FDA-
APPROVED indication or the National Comprehensive Cancer11
Network drugs and biologics compendium indication for the treatment of12
stage four advanced metastatic cancer; or13
(b) Peer-reviewed medical literature.14
(2) For the purposes of
AS USED IN this section:15
(a) "Stage four advanced metastatic cancer" means cancer that has16
spread from the primary or original site of the cancer to nearby tissues,17
lymph nodes, or other parts of the body.18
(b) "STEP THERAPY" HAS THE SAME MEANING AS SPECIFIED IN19
SECTION 10-16-145 (1)(g).20
SECTION 5. In Colorado Revised Statutes, amend as it will21
become effective January 1, 2023, 10-16-145.5 as follows:22
10-16-145.5. Step therapy - prior authorization - prohibited -23
stage four advanced metastatic cancer - opioid prescription -24
definitions. (1) (a) Notwithstanding section 10-16-145, a carrier that25
provides coverage under a health benefit plan for the treatment of stage26
four advanced metastatic cancer shall not limit or exclude coverage under27
1370
-11- the health benefit plan for a drug that is approved by the FDA and that is1
on the carrier's prescription drug formulary by mandating that a covered2
person with stage four advanced metastatic cancer undergo step-therapy3
STEP THERAPY if the use of the approved drug is consistent with:4
(I) (a) The FDA-approved indication or the National5
Comprehensive Cancer Network drugs and biologics compendium6
indication for the treatment of stage four advanced metastatic cancer; or7
(II) (b) Peer-reviewed medical literature.8
(b) As used in this subsection (1), "stage four advanced metastatic9
cancer" means cancer that has spread from the primary or original site of10
the cancer to nearby tissues, lymph nodes, or other parts of the body.11
(2) (a) Notwithstanding section 10-16-145, a carrier that provides12
prescription drug benefits shall:13
(I) (a) Provide coverage for at least one atypical opioid that has14
been approved by the FDA for the treatment of acute or chronic pain at15
the lowest tier of the carrier's drug formulary and not require step-therapy16
STEP THERAPY or prior authorization, as defined in section 10-16-112.517
(7)(d), for that atypical opioid; and18
(II) (b) Not require step-therapy STEP THERAPY for the prescription19
and use of any additional atypical opioid medications that have been20
approved by the FDA for the treatment of acute or chronic pain.21
(b) As used in this subsection (2), "atypical opioid" means an22
opioid agonist with a documented safer side-effect profile and less risk of23
addiction than older opium-based medications.24
(3) A
S USED IN THIS SECTION:25
(a) "A
TYPICAL OPIOID" MEANS AN OPIOID AGONIST WITH A26
DOCUMENTED SAFER SIDE-EFFECT PROFILE AND LESS RISK OF ADDICTION27
1370
-12- THAN OLDER OPIUM-BASED MEDICATIONS.1
(b) "S
TAGE FOUR ADVANCED METASTATIC CANCER " MEANS2
CANCER THAT HAS SPREAD FROM THE PRIMARY OR ORIGINAL SITE OF THE3
CANCER TO NEARBY TISSUES , LYMPH NODES, OR OTHER PARTS OF THE4
BODY.5
(c)
"STEP THERAPY" HAS THE SAME MEANING AS SPECIFIED IN6
SECTION 10-16-145 (1)(g).7
SECTION 6. In Colorado Revised Statutes, add 10-16-155 as8
follows:9
10
10-16-155. Prescription drugs - rebates - consumer cost11
reduction - point of sale - study - report - rules - definitions. (1) AS12
USED IN THIS SECTION, UNLESS THE CONTEXT OTHERWISE REQUIRES :13
(a) "DISCOUNT" MEANS PRICE REDUCTIONS OR CONCESSIONS,14
INCLUDING BASE PRICE CONCESSIONS OR OTHER CONTRACTUAL15
AGREEMENTS MADE BY A MANUFACTURER OR ITS AFFILIATE , THAT REDUCE16
PAYMENT OR LIABILITY FOR PRESCRIPTION DRUGS INCLUDING A17
REDUCTION IN THE TOTAL AMOUNT PAID FOR PRESCRIPTION DRUGS ,18
WITHOUT REGARD TO PERFORMANCE, VOLUME, OR UTILIZATION OF THE19
DRUGS AND ALL OTHER COMPENSATION THAT REDUCES PAYMENT OR20
LIABILITY FOR PRESCRIPTION DRUGS. "DISCOUNT" DOES NOT INCLUDE A21
REBATE.22
(b) "HEALTH INSURER" MEANS A CARRIER:23
(I) AS DEFINED IN SECTION 10-16-102 (8); AND24
(II) AS DEFINED IN SECTION 24-50-603 (2).25
(c) "MANUFACTURER" HAS THE SAME MEANING AS SET FORTH IN26
SECTION 10-16-1401 (16).27
1370
-13- (d) "PRESCRIPTION DRUG" HAS THE SAME MEANING AS SET FORTH1
IN SECTION 12-280-103 (42); EXCEPT THAT THE TERM INCLUDES ONLY2
PRESCRIPTION DRUGS THAT ARE INTENDED FOR HUMAN USE .3
(e) "REBATE" MEANS ALL PRICE CONCESSIONS MADE BY A4
MANUFACTURER OR ITS AFFILIATE THAT ACCRUE TO A PBM OR ITS HEALTH5
INSURER CLIENT, INCLUDING CREDITS OR INCENTIVES THAT ARE BASED ON6
ACTUAL OR ESTIMATED UTILIZATION OF PRESCRIPTION DRUGS; THAT7
RESULT IN THE PLACEMENT OF A PRESCRIPTION DRUG IN A PREFERRED8
DRUG LIST OR FORMULARY OR PREFERRED FORMULARY POSITION ; OR THAT9
ARE ASSOCIATED WITH CLAIMS ADMINISTERED ON BEHALF OF AN INSURER10
CLIENT. "REBATE" ALSO INCLUDES CREDITS, INCENTIVES, REFUNDS, AND11
ALL OTHER COMPENSATION THAT IS PERFORMANCE-BASED. "REBATE"12
DOES NOT INCLUDE A DISCOUNT.13
(2) FOR EACH HEALTH BENEFIT PLAN ISSUED OR RENEWED ON OR14
AFTER JANUARY 1, 2024, A HEALTH INSURER SHALL ENSURE THAT ONE15
HUNDRED PERCENT OF DISCOUNTS RECEIVED OR TO BE RECEIVED FROM A16
MANUFACTURER IN CONNECTION WITH DISPENSING OR ADMINISTERING17
PRESCRIPTION DRUGS INCLUDED IN THE HEALTH INSURER'S FORMULARY,18
AS DEMONSTRATED IN THE HEALTH INSURER'S RATE FILING PURSUANT TO19
SECTION 10-16-107, FOR THAT PLAN YEAR ARE USED TO REDUCE COSTS .20
(3) FOR EACH HEALTH BENEFIT PLAN ISSUED OR RENEWED ON OR21
AFTER JANUARY 1, 2024, A HEALTH INSURER SHALL ENSURE THAT :22
(a) ONE HUNDRED PERCENT OF THE ESTIMATED REBATES RECEIVED23
OR TO BE RECEIVED IN CONNECTION WITH DISPENSING OR ADMINISTERING24
PRESCRIPTION DRUGS INCLUDED IN THE HEALTH INSURER'S FORMULARY25
FOR THAT PLAN YEAR ARE USED TO REDUCE POLICYHOLDER COSTS ;26
(b) FOR SMALL GROUP AND LARGE GROUP HEALTH BENEFIT PLANS,27
1370
-14- ALL REBATES ARE USED TO REDUCE EMPLOYER OR INDIVIDUAL EMPLOYEE1
COSTS; AND2
(c) FOR INDIVIDUAL HEALTH BENEFIT PLANS, ALL REBATES ARE3
USED TO REDUCE CONSUMER PREMIUMS AND OUT-OF-POCKET COSTS FOR4
PRESCRIPTION DRUGS AND THAT HEALTH INSURERS WILL MAXIMIZE THE5
USE OF REBATES TO REDUCE CONSUMER OUT-OF-POCKET COSTS AT THE6
POINT OF SALE NOT TO EXCEED THE CONSUMER'S ACTUAL OUT-OF-POCKET7
COSTS FOR THE PRESCRIPTION DRUG IF THE USE OF SUCH REBATES WILL8
NOT:9
(I) INCREASE PREMIUMS;10
(II) CHANGE THE ACTUARIAL VALUE OF THE PLAN INCONSISTENT11
WITH FEDERAL AND STATE REQUIREMENTS ; OR12
(III) OTHERWISE RESULT IN AN IMPACT THAT IS NOT IN THE BEST13
INTEREST OF CONSUMERS.14
(4) (a) ON OR BEFORE JUNE 1, 2023, THE DIVISION SHALL CONDUCT15
AND COMPLETE A STUDY TO EVALUATE HOW REBATES MAY BE APPLIED IN16
THE INDIVIDUAL MARKET TO REDUCE A COVERED PERSON 'S17
OUT-OF-POCKET COSTS AT THE POINT OF SALE OR TO REDUCE18
OUT-OF-POCKET COSTS IN PRESCRIPTION DRUG TIERS , TAKING INTO19
CONSIDERATION THE FOLLOWING FACTORS :20
(I) PREMIUM IMPACTS;21
(II) CHANGES IN THE PLAN'S ACTUARIAL VALUE; AND22
(III) OTHER POTENTIAL IMPACTS TO CONSUMERS .23
(b) REGARDLESS OF THE RESULTS OF THE STUDY, A HEALTH24
INSURER SHALL COMPLY WITH SUBSECTION (3) OF THIS SECTION.25
(c) THE DIVISION MAY CONTRACT WITH A THIRD PARTY TO26
CONDUCT THE STUDY REQUIRED BY THIS SUBSECTION (4). THE27
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CODE", ARTICLES 101 TO 112 OF TITLE 24, FOR THE PURPOSES OF THIS2
SECTION, BUT SHALL ENSURE A COMPETITIVE PROCESS IS USED TO SELECT3
A THIRD PARTY TO CONDUCT THE STUDY .4
(5) EACH HEALTH INSURER SHALL REPORT ANNUALLY :5
(a) IN A FORM AND MANNER DETERMINED BY THE COMMISSIONER ,6
DATA DEMONSTRATING THAT ALL DISCOUNTS AND REBATES RECEIVED BY7
HEALTH INSURERS ARE USED TO REDUCE COSTS FOR POLICYHOLDERS IN8
COMPLIANCE WITH THIS SECTION. THE COMMISSIONER MAY USE DISCOUNT9
AND REBATE DATA SUBMITTED BY HEALTH INSURERS TO THE ALL-PAYER10
HEALTH CLAIMS DATABASE DESCRIBED IN SECTION 25.5-1-204 TO THE11
EXTENT SUCH DATA ARE AVAILABLE FROM THE ALL -PAYER HEALTH12
CLAIMS DATABASE.13
(b) AN ACTUARIAL CERTIFICATION THAT ATTESTS THAT :14
(I) THE HEALTH INSURER AND PBM ARE IN COMPLIANCE WITH15
SUBSECTIONS (2) AND (3) OF THIS SECTION; AND16
(II) THE DATA REPORTED AS REQUIRED BY THIS SECTION ARE17
ACCURATE.18
(6) THE DIVISION MAY USE DATA FROM THE DEPARTMENT OF19
HEALTH CARE POLICY AND FINANCING, THE ALL-PAYER HEALTH CLAIMS20
DATABASE DESCRIBED IN SECTION 25.5-1-204, AND OTHER SOURCES TO21
VERIFY THAT A HEALTH INSURER AND PBM ARE IN COMPLIANCE WITH THIS22
SECTION.23
(7) INFORMATION SUBMITTED BY THE HEALTH INSURERS AND24
PBMS TO THE DIVISION IN ACCORDANCE WITH THIS SECTION IS SUBJECT TO25
PUBLIC INSPECTION ONLY TO THE EXTENT ALLOWED UNDER THE26
"COLORADO OPEN RECORDS ACT", PART 2 OF ARTICLE 72 OF TITLE 24,27
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INFORMATION BE DISCLOSED TO ANY PERSON WHO IS NOT OTHERWISE2
AUTHORIZED TO ACCESS SUCH INFORMATION .3
(8) THIS SECTION DOES NOT PROHIBIT A HEALTH INSURER FROM4
DECREASING COST-SHARING AMOUNTS OR PREMIUMS BY AN AMOUNT5
GREATER THAN THE AMOUNT REQUIRED IN SUBSECTION (2) OR (3) OF THIS6
SECTION.7
(9) THE REQUIREMENTS OF SUBSECTIONS (2), (3), AND (5) OF THIS8
SECTION APPLY TO A SELF-FUNDED HEALTH BENEFIT PLAN AND ITS PLAN9
MEMBERS ONLY IF THE ENTITY THAT PROVIDES THE PLAN ELECTS TO BE10
SUBJECT TO SUBSECTIONS (2), (3), AND (5) OF THIS SECTION FOR ITS11
MEMBERS IN COLORADO.12
(10) THE COMMISSIONER SHALL PROMULGATE RULES TO13
IMPLEMENT AND ENFORCE THIS SECTION .14
SECTION 7. In Colorado Revised Statutes, add 25.5-5-513 as15
follows:16
25.5-5-513. Pharmacy benefits - prescription drugs - rebates17
- analysis. (1) B
EGINNING IN 2023, THE STATE DEPARTMENT SHALL , IN18
COLLABORATION WITH THE ADMINISTRATOR OF THE ALL -PAYER CLAIMS19
DATABASE DESCRIBED IN SECTION 25.5-1-204, CONDUCT AN ANNUAL20
ANALYSIS OF THE PRESCRIPTION DRUG REBATES RECEIVED IN THE21
PREVIOUS CALENDAR YEAR , BY HEALTH INSURANCE CARRIER AND22
PRESCRIPTION DRUG TIER. THE ANALYSIS, USING DATA FROM THE23
ALL-PAYERS CLAIM DATABASE AND OTHER SOURCES , MUST BE COMPLETED24
ON OR BEFORE MAY 1 OF EACH YEAR.25
(2) T
HE STATE DEPARTMENT SHALL MAKE THE ANALYSIS26
CONDUCTED IN SUBSECTION (1) OF THIS SECTION AVAILABLE TO THE27
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SECTION 8. Appropriation. (1) For the 2022-23 state fiscal2
year, $252,667 is appropriated to the department of regulatory agencies3
for use by the division of insurance. This appropriation is from the4
division of insurance cash fund created in section 10-1-103 (3), C.R.S. To5
implement this act, the division may use this appropriation as follows:6
(a) $237,972 for personal services, which amount is based on an7
assumption that the division will require an additional 1.7 FTE; and8
(b) $14,695 for operating expenses.9
10
SECTION 9. Act subject to petition - effective date -11
applicability. (1) This act takes effect at 12:01 a.m. on the day following12
the expiration of the ninety-day period after final adjournment of the13
general assembly; except that, if a referendum petition is filed pursuant14
to section 1 (3) of article V of the state constitution against this act or an15
item, section, or part of this act within such period, then the act, item,16
section, or part will not take effect unless approved by the people at the17
general election to be held in November 2022 and, in such case, will take18
effect on the date of the official declaration of the vote thereon by the19
governor.20
(2) Section 1 of this act applies to health benefit plans issued or21
renewed on or after January 1, 2023.22
(3) Sections 2 through 6 of this act apply to health benefit plans23
issued or renewed on or after January 1, 2024.24
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