HOUSE BILL 22-1370
BY REPRESENTATIVE(S) 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, Herod, Lontine,
McCormick, McLachlan, Ricks, Titone, Valdez D., Garnett, Benavidez,
Daugherty, Tipper, Valdez A.;
also SENATOR(S) Winter and Buckner, Jaquez Lewis, Pettersen.
C
ONCERNING COVERAGE REQUIREMENTS FOR HEALTH -CARE PRODUCTS,
AND, IN CONNECTION THEREWITH, MAKING AN APPROPRIATION.
Be it enacted by the General Assembly of the State of Colorado:
SECTION 1. In Colorado Revised Statutes, add 10-16-103.6 as
follows:
10-16-103.6. Copayment-only prescription payment structures
- required inclusion in health benefit plans - rules. (1) (a) I
N ADDITION
TO THE REQUIREMENTS IN SECTION
10-16-103.4 (2), FOR HEALTH BENEFIT
PLANS ISSUED OR RENEWED ON OR AFTER
JANUARY 1, 2023, EACH CARRIER
THAT OFFERS AN INDIVIDUAL OR SMALL GROUP HEALTH BENEFIT PLAN SHALL
OFFER AT LEAST TWENTY
-FIVE PERCENT OF ITS HEALTH BENEFIT PLANS ON
NOTE: This bill has been prepared for the signatures of the appropriate legislative
officers and the Governor. To determine whether the Governor has signed the bill
or taken other action on it, please consult the legislative status sheet, the legislative
history, or the Session Laws.
________
Capital letters or bold & italic numbers indicate new material added to existing law; dashes
through words or numbers indicate deletions from existing law and such material is not part of
the act. THE EXCHANGE AND AT LEAST TWENTY -FIVE PERCENT OF ITS PLANS NOT ON
THE EXCHANGE IN EACH BRONZE
, SILVER, GOLD, AND PLATINUM BENEFIT
LEVEL IN EACH SERVICE AREA AS COPAYMENT
-ONLY PAYMENT STRUCTURES
FOR ALL PRESCRIPTION DRUG COST TIERS
.
(b) F
OR EACH COPAYMENT -ONLY PAYMENT STRUCTURE FOR
PRESCRIPTIONS DRUGS
:
(I) T
HE COPAYMENT AMOUNT FOR THE HIGHEST PRESCRIPTION DRUG
COST TIER MUST NOT BE GREATER THAN ONE
-TWELFTH OF THE HEALTH
BENEFIT PLAN
'S OUT-OF-POCKET MAXIMUM AMOUNT ;
(II) T
HE COPAYMENT AMOUNTS BETWEEN THE TWO HIGHEST
PRESCRIPTION DRUG COST TIERS MUST HAVE A COST DIFFERENCE OF AT
LEAST TEN PERCENT
;
(III) N
O MORE THAN FIFTY PERCENT OF THE DRUGS ON THE
PRESCRIPTION DRUG FORMULARY USED TO TREAT A SPECIFIC CONDITION MAY
BE PLACED ON THE HIGHEST PRESCRIPTION DRUG COST TIER
; AND
(IV) EACH CARRIER SHALL USE "RX COPAY" AT THE END OF THE
MARKETING NAMES FOR EACH COPAYMENT
-ONLY PAYMENT STRUCTURE .
(2) T
HE COMMISSIONER MAY PROMULGATE RULES TO IMPLEMENT
AND ENFORCE THIS SECTION
.
SECTION 2. In Colorado Revised Statutes, add 10-16-122.4 as
follows:
10-16-122.4. Pharmacy benefits - formulary change prohibition
- exceptions - definition - rules. (1) (a) S
TARTING IN 2024, EXCEPT AS
PROVIDED IN SUBSECTION
(2) OF THIS SECTION, A CARRIER OR, IF A CARRIER
USES A
PBM FOR CLAIMS PROCESSING SERVICES OR OTHER PRESCRIPTION
DRUG OR DEVICE SERVICES
, AS THOSE TERMS ARE DEFINED IN SECTION
10-16-122.1, UNDER A HEALTH BENEFIT PLAN OFFERED BY THE CARRIER IN
THE INDIVIDUAL MARKET
, THE PBM, OR A REPRESENTATIVE OF THE CARRIER
OR THE
PBM, SHALL NOT MODIFY OR APPLY A MODIFICATION TO THE
CURRENT PRESCRIPTION DRUG FORMULARY DURING THE CURRENT PLAN
YEAR
.
PAGE 2-HOUSE BILL 22-1370 (b) AS USED IN THIS SUBSECTION (1), "MODIFY" OR "MODIFICATION"
INCLUDES ELIMINATING A PARTICULAR PRESCRIPTION DRUG FROM THE
FORMULARY OR MOVING A PRESCRIPTION DRUG TO A HIGHER COST
-SHARING
TIER
.
(2) A
CARRIER OFFERING A HEALTH BENEFIT PLAN ON THE
INDIVIDUAL MARKET IN THIS STATE THAT INCLUDES A PRESCRIPTION DRUG
BENEFIT AND USES A PRESCRIPTION DRUG FORMULARY OR LIST OF COVERED
DRUGS MAY
:
(a) R
EMOVE A PRESCRIPTION DRUG FROM THE PRESCRIPTION DRUG
FORMULARY OR LIST OF COVERED DRUGS
, WITH NOTICE TO A COVERED
PERSON AND THE COVERED PERSON
'S PROVIDER, IF:
(I) T
HE FDA ISSUES AN ANNOUNCEMENT , GUIDANCE, NOTICE,
WARNING, OR STATEMENT CONCERNING THE PRESCRIPTION DRUG THAT
CALLS INTO QUESTION THE CLINICAL SAFETY OF THE PRESCRIPTION DRUG
; OR
(II) THE PRESCRIPTION DRUG IS APPROVED BY THE FDA FOR USE
WITHOUT A PRESCRIPTION
;
(b) M
OVE A PRESCRIPTION DRUG FROM A PRESCRIPTION DRUG
COST
-SHARING TIER THAT IMPOSES A LESSER COPAYMENT OR DEDUCTIBLE
FOR THE PRESCRIPTION DRUG TO A COST
-SHARING TIER THAT IMPOSES A
GREATER COPAYMENT OR DEDUCTIBLE FOR THE PRESCRIPTION DRUG IF THE
CARRIER ADDS TO THE PRESCRIPTION DRUG FORMULARY OR LIST OF COVERED
DRUGS A GENERIC PRESCRIPTION DRUG OR BIOSIMILAR DRUG THAT IS
:
(I) A
PPROVED BY THE FDA FOR USE AS A THERAPEUTIC EQUIVALENT;
AND
(II) IN A PRESCRIPTION DRUG COST-SHARING TIER THAT IMPOSES A
COPAYMENT OR DEDUCTIBLE FOR THE GENERIC PRESCRIPTION DRUG OR
BIOSIMILAR DRUG THAT IS LESS THAN THE COPAYMENT OR DEDUCTIBLE THAT
IS IMPOSED FOR THE BRAND
-NAME PRESCRIPTION DRUG IN THE
COST
-SHARING TIER TO WHICH THE BRAND -NAME PRESCRIPTION DRUG IS
MOVED
;
(c) R
EMOVE A PRESCRIPTION DRUG FROM THE PRESCRIPTION DRUG
FORMULARY OR LIST OF COVERED DRUGS
, OR MOVE A PRESCRIPTION DRUG
PAGE 3-HOUSE BILL 22-1370 TO A HIGHER COST SHARING TIER, WITH ADVANCE NOTICE TO A COVERED
PERSON AND THE COVERED PERSON
'S PROVIDER, IF:
(I) T
HE PRESCRIPTION DRUG HAS A WHOLESALE ACQUISITION COST
GREATER THAN FIVE HUNDRED DOLLARS AT THE START OF THE BENEFIT YEAR
AND THE CARRIER
'S NET COST INCREASES BY FIFTEEN PERCENT OR MORE
DURING THAT BENEFIT YEAR
; AND
(II) THE PRESCRIPTION DRUG WILL BE REPLACED ON THE FORMULARY
WITH A THERAPEUTICALLY EQUIVALENT GENERIC OR MULTI
-SOURCE BRAND
NAME DRUG
, AN INTERCHANGEABLE BIOLOGIC , OR BIOSIMILAR DRUG AT A
LOWER COST TO THE ENROLLEE
; OR
(d) PRIOR TO REMOVING A DRUG FROM A FORMULARY PURSUANT TO
THIS SECTION
, THE CARRIER MUST ATTEST AND DEMONSTRATE TO THE
DIVISION
, IN A FORM AND MANNER DETERMINED BY THE COMMISSIONER BY
RULE
, THAT IT HAS COMPLIED WITH THE REQUIREMENTS OF THIS SECTION
AND HAS PROVIDED ADVANCED NOTICE TO ITS ENROLLEES
.
(3) T
HIS SECTION DOES NOT PROHIBIT A CARRIER FROM ADDING A
PRESCRIPTION DRUG TO A PRESCRIPTION DRUG FORMULARY OR LIST OF
COVERED DRUGS AT ANY TIME
.
(4) T
HE COMMISSIONER MAY PROMULGATE RULES TO IMPLEMENT
AND ENFORCE THIS SECTION
.
SECTION 3. In Colorado Revised Statutes, repeal and reenact,
with amendments, 10-16-145 as follows:
10-16-145. Step-therapy protocol - limitations - exceptions -
definitions - rules. (1) A
S USED IN THIS SECTION:
(a) "B
IOSIMILAR" HAS THE MEANING SET FORTH IN 42 U.S.C. SEC.
262 (i)(2).
(b) "C
LINICAL PRACTICE GUIDELINES" MEANS A SYSTEMATICALLY
DEVELOPED STATEMENT TO ASSIST PROVIDERS AND COVERED PERSONS IN
MAKING DECISIONS ABOUT APPROPRIATE HEALTH CARE FOR SPECIFIC
CLINICAL CIRCUMSTANCES AND CONDITIONS
.
PAGE 4-HOUSE BILL 22-1370 (c) "CLINICAL REVIEW CRITERIA" MEANS THE WRITTEN SCREENING
PROCEDURES
, DECISION ABSTRACTS, CLINICAL PROTOCOLS, AND CLINICAL
PRACTICE GUIDELINES USED BY A CARRIER OR PRIVATE UTILIZATION REVIEW
ORGANIZATION TO D ETERMINE THE MEDICAL NECESSITY AND
APPROPRIATENESS OF THE PROVISION OF HEALTH
-CARE SERVICES. CLINICAL
REVIEW CRITERIA MUST NOT BE MORE RESTRICTIVE THAN THE
FDA'S
INDICATION FOR A SPECIFIC DRUG OR HEALTH
-CARE SERVICE.
(d) "E
XIGENT CIRCUMSTANCE" MEANS A CIRCUMSTANCE IN WHICH
A COVERED PERSON IS SUFFERING FROM A HEALTH CONDITION THAT MAY
SERIOUSLY JEOPARDIZE THE COVERED PERSON
'S LIFE, HEALTH, OR ABILITY
TO REGAIN MAXIMUM FUNCTIONS
.
(e) "M
EDICAL NECESSITY" HAS THE SAME MEANING AS SET FORTH IN
SECTION
10-16-112.5.
(f) "P
RIVATE UTILIZATION REVIEW ORGANIZATION " OR
"ORGANIZATION" HAS THE SAME MEANING AS SET FORTH IN SECTION
10-16-112 (1)(a).
(g) "S
TEP THERAPY" MEANS A PROTOCOL THAT REQUIRES A COVERED
PERSON TO USE A PRESCRIPTION DRUG OR SEQUENCE OF PRESCRIPTION
DRUGS
, OTHER THAN THE DRUG THAT THE COVERED PERSON 'S HEALTH-CARE
PROVIDER RECOMMENDS FOR THE COVERED PERSON
'S TREATMENT, BEFORE
THE CARRIER PROVIDES COVERAGE FOR THE RECOMMENDED PRESCRIPTION
DRUG
.
(2) I
F A CARRIER, A PRIVATE UTILIZATION REVIEW ORGANIZATION, OR
A
PBM REQUIRES STEP THERAPY, THE CARRIER, ORGANIZATION, OR PBM
SHALL USE CLINICAL REVIEW CRITERIA TO ESTABLISH THE PROTOCOL FOR
STEP THERAPY BASED ON CLINICAL PRACTICE GUIDELINES
.
(3) A
CARRIER, PRIVATE UTILIZATION REVIEW ORGANIZATION , OR
PBM SHALL:
(a) M
AKE THE CLINICAL REVIEW CRITERIA AND THE STEP THERAPY
EXEMPTION PROCESS AVAILABLE ON THEIR WEBSITES
; AND
(b) UPON WRITTEN REQUEST , PROVIDE ALL SPECIFIC CLINICAL
REVIEW CRITERIA AND OTHER CLINICAL INFORMATION RELATING TO A
PAGE 5-HOUSE BILL 22-1370 COVERED PERSON'S PARTICULAR CONDITION OR DISEASE , INCLUDING
CLINICAL REVIEW CRITERIA RELATING TO A STEP
-THERAPY EXCEPTION, TO
THE REQUESTER
.
(4) (a) A
CARRIER, A PRIVATE UTILIZATION REVIEW ORGANIZATION ,
OR A PBM SHALL GRANT AN EXCEPTION TO STEP THERAPY IF THE
PRESCRIBING PROVIDER SUBMITS JUSTIFICATION AND SUPPORTING CLINICAL
DOCUMENTATION
, IF NEEDED, THAT STATES:
(I) T
HE PROVIDER ATTESTS THAT THE REQUIRED PRESCRIPTION DRUG
IS CONTRAINDICATED OR WILL LIKELY CAUSE AN ADVERSE REACTION OR
HARM TO THE COVERED PERSON
;
(II) T
HE REQUIRED PRESCRIPTION DRUG IS INEFFECTIVE BASED ON
THE KNOWN CLINICAL CHARACTERISTICS OF THE COVERED PERSON AND THE
KNOWN CHARACTERISTICS OF THE PRESCRIPTION DRUG REGIMEN
;
(III) T
HE COVERED PERSON HAS TRIED, WHILE UNDER THE COVERED
PERSON
'S CURRENT OR PREVIOUS HEALTH BENEFIT PLAN , THE REQUIRED
PRESCRIPTION DRUG OR ANOTHER PRESCRIPTION DRUG IN THE SAME
PHARMACOLOGIC CLASS OR WITH THE SAME MECHANISM OF ACTION
, AND
THE USE OF THE PRESCRIPTION DRUG BY THE COVERED PERSON WAS
DISCONTINUED DUE TO LACK OF EFFICACY OR EFFECTIVENESS
, DIMINISHED
EFFECT
, OR AN ADVERSE EVENT;
(IV) T
HE COVERED PERSON, WHILE ON THE COVERED PERSON 'S
CURRENT OR PREVIOUS HEALTH BENEFIT PLAN
, IS STABLE ON A PRESCRIPTION
DRUG SELECTED BY THE PRESCRIBING PROVIDER FOR THE MEDICAL
CONDITION UNDER CONSIDERATION AFTER UNDERGOING STEP THERAPY OR
AFTER HAVING SOUGHT AND RECEIVED A STEP
-THERAPY EXCEPTION.
(b) (I) E
XCEPT AS PROVIDED IN SUBSECTION (4)(b)(II) OF THIS
SECTION
, A CARRIER, ORGANIZATION, OR PBM SHALL GRANT OR DENY A
STEP THERAPY EXCEPTION REQUEST OR AN APPEAL OF A DENIAL OF A
REQUEST WITHIN
:
(A) T
HREE BUSINESS DAYS AFTER RECEIPT OF THE REQUEST ; OR
(B) IN CASES WHERE EXIGENT CIRCUMSTANCES EXIST , WITHIN
TWENTY
-FOUR HOURS AFTER RECEIPT OF THE REQUEST .
PAGE 6-HOUSE BILL 22-1370 (II) IF A REQUEST FOR A STEP THERAPY EXCEPTION OR AN APPEAL OF
A DENIAL OF A REQUEST IS INCOMPLETE OR IF ADDITIONAL CLINICALLY
RELEVANT INFORMATION IS REQUIRED
, THE CARRIER, ORGANIZATION, OR
PBM SHALL NOTIFY THE PRESCRIBING PROVIDER WITHIN SEVENTY -TWO
HOURS AFTER SUBMISSION OF THE REQUEST
, OR WITHIN TWENTY-FOUR
HOURS AFTER THE SUBMISSION OF THE REQUEST IF EXIGENT CIRCUMSTANCES
EXIST
, THAT THE REQUEST OR APPEAL IS INCOMPLETE OR THAT ADDITIONAL
CLINICALLY RELEVANT INFORMATION IS REQUIRED
. THE CARRIER,
ORGANIZATION, OR PBM MUST SPECIFY THE ADDITIONAL INFORMATION
THAT IS REQUIRED IN ORDER TO CONSIDER THE STEP THERAPY EXCEPTION
REQUEST OR THE APPEAL OF THE DENIAL OF THE REQUEST PURSUANT TO THE
CRITERIA DESCRIBED IN SUBSECTION
(4)(a) OF THIS SECTION. ONCE THE
REQUESTED INFORMATION IS SUBMITTED TO THE CARRIER
, ORGANIZATION,
OR PBM, THE APPLICABLE PERIOD TO GRANT OR DENY A STEP THERAPY
EXCEPTION REQUEST OR AN APPEAL OF A DENIAL OF A REQUEST
, AS
SPECIFIED IN SUBSECTION
(4)(b)(I) OF THIS SECTION, APPLIES.
(III) I
F A CARRIER, ORGANIZATION, OR PBM DOES NOT MAKE A
DETERMINATION REGARDING THE STEP THERAPY EXCEPTION REQUEST OR
THE APPEAL OF THE DENIAL OF THE REQUEST OR DOES NOT MAKE A REQUEST
FOR ADDITIONAL OR CLINICALLY RELEVANT INFORMATION WITHIN THE
REQUIRED TIME
, THE STEP THERAPY EXCEPTION REQUEST OR THE APPEAL OF
THE DENIAL OF THE REQUEST IS DEEMED GRANTED
.
(c) I
F THE INITIAL REQUEST FOR A STEP-THERAPY EXCEPTION IS
DENIED
, THE CARRIER, ORGANIZATION, OR PBM SHALL INFORM THE
COVERED PERSON IN WRITING THAT THE COVERED PERSON HAS THE RIGHT TO
AN INTERNAL OR EXTERNAL REVIEW OR AN APPEAL OF THE ADVERSE
DETERMINATION PURSUANT TO SECTIONS
10-16-113 AND 10-16-113.5.
(d) A
CARRIER, AN ORGANIZATION, OR A PBM SHALL AUTHORIZE
COVERAGE FOR THE PRESCRIPTION DRUG PRESCRIBED BY THE COVERED
PERSON
'S PRESCRIBING PROVIDER WHEN THE STEP -THERAPY EXCEPTION
REQUEST IS GRANTED
.
(5) T
HIS SECTION DOES NOT PROHIBIT:
(a) A
CARRIER, AN ORGANIZATION, OR A PBM FROM REQUIRING A
COVERED PERSON TO TRY A GENERIC EQUIVALENT DRUG
, A BIOSIMILAR
DRUG
, OR AN INTERCHANGEABLE BIOLOGICAL PRODUCT AS DEFINED BY 42
PAGE 7-HOUSE BILL 22-1370 U.S.C. SEC. 262 (i)(3), UNLESS THE COVERED PERSON OR COVERED PERSON 'S
PRESCRIBING PROVIDER HAS REQUESTED A STEP
-THERAPY EXCEPTION AND
THE PRESCRIBED DRUG MEETS THE CRITERIA FOR A STEP
-THERAPY
EXCEPTION SPECIFIED IN SUBSECTION
(4)(a) OF THIS SECTION;
(b) A
CARRIER, AN ORGANIZATION, OR A PBM FROM REQUIRING A
PHARMACIST TO MAKE SUBSTITUTIONS OF PRESCRIPTION DRUGS CONSISTENT
WITH PART
5 OF ARTICLE 280 OF TITLE 12; OR
(c) A PROVIDER FROM PRESCRIBING A DRUG THAT IS DETERMINED TO
BE MEDICALLY APPROPRIATE
.
(6) T
HE COMMISSIONER MAY PROMULGATE RULES TO IMPLEMENT
AND ENFORCE THIS SECTION
.
SECTION 4. In Colorado Revised Statutes, amend as it exists
until January 1, 2023, 10-16-145.5 as follows:
10-16-145.5. Step therapy prohibited - stage four advanced
metastatic cancer - definitions. (1) Notwithstanding section 10-16-145,
a carrier that provides coverage under a health benefit plan for the treatment
of stage four advanced metastatic cancer shall not limit or exclude coverage
under the health benefit plan for a drug approved by the United States food
and drug administration FDA and that is on the carrier's prescription drug
formulary by mandating that a covered person with stage four advanced
metastatic cancer undergo step-therapy
STEP THERAPY if the use of the
approved drug is consistent with:
(a) The United States food and drug administration-approved
FDA-APPROVED indication or the National Comprehensive Cancer Network
drugs and biologics compendium indication for the treatment of stage four
advanced metastatic cancer; or
(b) Peer-reviewed medical literature.
(2) For the purposes of
AS USED IN this section:
(a) "Stage four advanced metastatic cancer" means cancer that has
spread from the primary or original site of the cancer to nearby tissues,
lymph nodes, or other parts of the body.
PAGE 8-HOUSE BILL 22-1370 (b) "STEP THERAPY" HAS THE SAME MEANING AS SPECIFIED IN
SECTION
10-16-145 (1)(g).
SECTION 5. In Colorado Revised Statutes, amend as it will
become effective January 1, 2023, 10-16-145.5 as follows:
10-16-145.5. Step therapy - prior authorization - prohibited -
stage four advanced metastatic cancer - opioid prescription -
definitions. (1) (a)
Notwithstanding section 10-16-145, a carrier that
provides coverage under a health benefit plan for the treatment of stage four
advanced metastatic cancer shall not limit or exclude coverage under the
health benefit plan for a drug that is approved by the FDA and that is on the
carrier's prescription drug formulary by mandating that a covered person
with stage four advanced metastatic cancer undergo step-therapy
STEP
THERAPY
if the use of the approved drug is consistent with:
(I)
(a) The FDA-approved indication or the National Comprehensive
Cancer Network drugs and biologics compendium indication for the
treatment of stage four advanced metastatic cancer; or
(II)
(b) Peer-reviewed medical literature.
(b) As used in this subsection (1), "stage four advanced metastatic
cancer" means cancer that has spread from the primary or original site of the
cancer to nearby tissues, lymph nodes, or other parts of the body.
(2) (a) Notwithstanding section 10-16-145, a carrier that provides
prescription drug benefits shall:
(I) (a) Provide coverage for at least one atypical opioid that has been
approved by the FDA for the treatment of acute or chronic pain at the
lowest tier of the carrier's drug formulary and not require step therapy or
prior authorization, as defined in section 10-16-112.5 (7)(d), for that
atypical opioid; and
(II)
(b) Not require step therapy for the prescription and use of any
additional atypical opioid medications that have been approved by the FDA
for the treatment of acute or chronic pain.
(b) As used in this subsection (2), "atypical opioid" means an opioid
PAGE 9-HOUSE BILL 22-1370 agonist with a documented safer side-effect profile and less risk of
addiction than older opium-based medications.
(3) AS USED IN THIS SECTION:
(a) "A
TYPICAL OPIOID" MEANS AN OPIOID AGONIST WITH A
DOCUMENTED SAFER SIDE
-EFFECT PROFILE AND LESS RISK OF ADDICTION
THAN OLDER OPIUM
-BASED MEDICATIONS.
(b) "S
TAGE FOUR ADVANCED METASTATIC CANCER " MEANS CANCER
THAT HAS SPREAD FROM THE PRIMARY OR ORIGINAL SITE OF THE CANCER TO
NEARBY TISSUES
, LYMPH NODES, OR OTHER PARTS OF THE BODY.
(c) "S
TEP THERAPY" HAS THE SAME MEANING AS SPECIFIED IN
SECTION
10-16-145 (1)(g).
SECTION 6. In Colorado Revised Statutes, add 10-16-156 as
follows:
10-16-156. Prescription drugs - rebates - consumer cost
reduction - point of sale - study - report - rules - definitions. (1) A
S
USED IN THIS SECTION
, UNLESS THE CONTEXT OTHERWISE REQUIRES :
(a) "D
ISCOUNT" MEANS PRICE REDUCTIONS OR CONCESSIONS ,
INCLUDING BASE PRICE CONCESSIONS OR OTHER CONTRACTUAL AGREEMENTS
MADE BY A MANUFACTURER OR ITS AFFILIATE
, THAT REDUCE PAYMENT OR
LIABILITY FOR PRESCRIPTION DRUGS INCLUDING A REDUCTION IN THE TOTAL
AMOUNT PAID FOR PRESCRIPTION DRUGS
, WITHOUT REGARD TO
PERFORMANCE
, VOLUME, OR UTILIZATION OF THE DRUGS AND ALL OTHER
COMPENSATION THAT REDUCES PAYMENT OR LIABILITY FOR PRESCRIPTION
DRUGS
. "DISCOUNT" DOES NOT INCLUDE A REBATE.
(b) "H
EALTH INSURER" MEANS A CARRIER:
(I) A
S DEFINED IN SECTION 10-16-102 (8); AND
(II) AS DEFINED IN SECTION 24-50-603 (2).
(c) "M
ANUFACTURER" HAS THE SAME MEANING AS SET FORTH IN
SECTION
10-16-1401 (16).
PAGE 10-HOUSE BILL 22-1370 (d) "PRESCRIPTION DRUG" HAS THE SAME MEANING AS SET FORTH IN
SECTION
12-280-103 (42); EXCEPT THAT THE TERM INCLUDES ONLY
PRESCRIPTION DRUGS THAT ARE INTENDED FOR HUMAN USE
.
(e) "R
EBATE" MEANS ALL PRICE CONCESSIONS MADE BY A
MANUFACTURER OR ITS AFFILIATE THAT ACCRUE TO A
PBM OR ITS HEALTH
INSURER CLIENT
, INCLUDING CREDITS OR INCENTIVES THAT ARE BASED ON
ACTUAL OR ESTIMATED UTILIZATION OF PRESCRIPTION DRUGS
; THAT RESULT
IN THE PLACEMENT OF A PRESCRIPTION DRUG IN A PREFERRED DRUG LIST OR
FORMULARY OR PREFERRED FORMULARY POSITION
; OR THAT ARE
ASSOCIATED WITH CLAIMS ADMINISTERED ON BEHALF OF AN INSURER
CLIENT
. "REBATE" ALSO INCLUDES CREDITS, INCENTIVES, REFUNDS, AND ALL
OTHER COMPENSATION THAT IS PERFORMANCE
-BASED. "REBATE" DOES NOT
INCLUDE A DISCOUNT
.
(2) F
OR EACH HEALTH BENEFIT PLAN ISSUED OR RENEWED ON OR
AFTER
JANUARY 1, 2024, A HEALTH INSURER SHALL ENSURE THAT ONE
HUNDRED PERCENT OF DISC OUNTS RECEIVED OR TO BE RECEIVED FROM A
MANUFACTURER IN CONNECTION WITH DISPENSING OR ADMINISTERING
PRESCRIPTION DRUGS INCLUDED IN THE HEALTH INSURER
'S FORMULARY, AS
DEMONSTRATED IN THE HEALTH INSURER
'S RATE FILING PURSUANT TO
SECTION
10-16-107, FOR THAT PLAN YEAR ARE USED TO REDUCE COSTS .
(3) F
OR EACH HEALTH BENEFIT PLAN ISSUED OR RENEWED ON OR
AFTER
JANUARY 1, 2024, A HEALTH INSURER SHALL ENSURE THAT :
(a) O
NE HUNDRED PERCENT OF THE ESTIMATED REBATES RECEIVED
OR TO BE RECEIVED IN CONNECTION WITH DISPENSING OR ADMINISTERING
PRESCRIPTION DRUGS INCLUDED IN THE HEALTH INSURER
'S FORMULARY FOR
THAT PLAN YEAR ARE USED TO REDUCE POLICYHOLDER COSTS
;
(b) F
OR SMALL GROUP AND LARGE GROUP HEALTH BENEFIT PLANS ,
ALL REBATES ARE USED TO REDUCE EMPLOYER OR INDIVIDUAL EMPLOYEE
COSTS
; AND
(c) FOR INDIVIDUAL HEALTH BENEFIT PLANS, ALL REBATES ARE USED
TO REDUCE CONSUMER PREMIUMS AND OUT
-OF-POCKET COSTS FOR
PRESCRIPTION DRUGS AND THAT HEALTH INSURERS WILL MAXIMIZE THE USE
OF REBATES TO REDUCE CONSUMER OUT
-OF-POCKET COSTS AT THE POINT OF
SALE NOT TO EXCEED THE CONSUMER
'S ACTUAL OUT-OF-POCKET COSTS FOR
PAGE 11-HOUSE BILL 22-1370 THE PRESCRIPTION DRUG IF THE USE OF SUCH REBATES WILL NOT :
(I) I
NCREASE PREMIUMS;
(II) C
HANGE THE ACTUARIAL VALUE OF THE PLAN INCONSISTENT
WITH FEDERAL AND STATE REQUIREMENTS
; OR
(III) OTHERWISE RESULT IN AN IMPACT THAT IS NOT IN THE BEST
INTEREST OF CONSUMERS
.
(4) (a) O
N OR BEFORE JUNE 1, 2023, THE DIVISION SHALL CONDUCT
AND COMPLETE A STUDY TO EVALUATE HOW REBATES MAY BE APPLIED IN
THE INDIVIDUAL MARKET TO REDUCE A COVERED PERSON
'S OUT-OF-POCKET
COSTS AT THE POINT OF SALE OR TO REDUCE OUT
-OF-POCKET COSTS IN
PRESCRIPTION DRUG TIERS
, TAKING INTO CONSIDERATION THE FOLLOWING
FACTORS
:
(I) P
REMIUM IMPACTS;
(II) C
HANGES IN THE PLAN'S ACTUARIAL VALUE; AND
(III) OTHER POTENTIAL IMPACTS TO CONSUMERS .
(b) R
EGARDLESS OF THE RESULTS OF THE STUDY, A HEALTH INSURER
SHALL COMPLY WITH SUBSECTION
(3) OF THIS SECTION.
(c) T
HE DIVISION MAY CONTRACT WITH A THIRD PARTY TO CONDUCT
THE STUDY REQUIRED BY THIS SUBSECTION
(4). THE COMMISSIONER IS NOT
REQUIRED TO COMPLY WITH THE
"PROCUREMENT CODE", ARTICLES 101 TO
112 OF TITLE 24, FOR THE PURPOSES OF THIS SECTION, BUT SHALL ENSURE A
COMPETITIVE PROCESS IS USED TO SELECT A THIRD PARTY TO CONDUCT THE
STUDY
.
(5) E
ACH HEALTH INSURER SHALL REPORT ANNUALLY :
(a) I
N A FORM AND MANNER DETERMINED BY THE COMMISSIONER ,
DATA DEMONSTRATING THAT ALL DISCOUNTS AND REBATES RECEIVED BY
HEALTH INSURERS ARE USED TO REDUCE COSTS FOR POLICYHOLDERS IN
COMPLIANCE WITH THIS SECTION
. THE COMMISSIONER MAY USE DISCOUNT
AND REBATE DATA SUBMITTED BY HEALTH INSURERS TO THE ALL
-PAYER
PAGE 12-HOUSE BILL 22-1370 HEALTH CLAIMS DATABASE DESCRIBED IN SECTION 25.5-1-204 TO THE
EXTENT SUCH DATA ARE AVAILABLE FROM THE ALL
-PAYER HEALTH CLAIMS
DATABASE
.
(b) A
N ACTUARIAL CERTIFICATION THAT ATTESTS THAT :
(I) T
HE HEALTH INSURER AND PBM ARE IN COMPLIANCE WITH
SUBSECTIONS
(2) AND (3) OF THIS SECTION; AND
(II) THE DATA REPORTED AS REQUIRED BY THIS SECTION ARE
ACCURATE
.
(6) T
HE DIVISION MAY USE DATA FROM THE DEPARTMENT OF HEALTH
CARE POLICY AND FINANCING
, THE ALL-PAYER HEALTH CLAIMS DATABASE
DESCRIBED IN SECTION
25.5-1-204, AND OTHER SOURCES TO VERIFY THAT A
HEALTH INSURER AND
PBM ARE IN COMPLIANCE WITH THIS SECTION.
(7) I
NFORMATION SUBMITTED BY THE HEALTH INSURERS AND PBMS
TO THE DIVISION IN ACCORDANCE WITH THIS SECTION IS SUBJECT TO PUBLIC
INSPECTION ONLY TO THE EXTENT ALLOWED UNDER THE
"COLORADO OPEN
RECORDS ACT", PART 2 OF ARTICLE 72 OF TITLE 24, AND IN NO CASE SHALL
TRADE
-SECRET, CONFIDENTIAL, OR PROPRIETARY INFORMATION BE
DISCLOSED TO ANY PERSON WHO IS NOT OTHERWISE AUTHORIZED TO ACCESS
SUCH INFORMATION
.
(8) T
HIS SECTION DOES NOT PROHIBIT A HEALTH INSURER FROM
DECREASING COST
-SHARING AMOUNTS OR PREMIUMS BY AN AMOUNT
GREATER THAN THE AMOUNT REQUIRED IN SUBSECTION
(2) OR (3) OF THIS
SECTION
.
(9) T
HE REQUIREMENTS OF SUBSECTIONS (2), (3), AND (5) OF THIS
SECTION APPLY TO A SELF
-FUNDED HEALTH BENEFIT PLAN AND ITS PLAN
MEMBERS ONLY IF THE ENTITY THAT PROVIDES THE PLAN ELECTS TO BE
SUBJECT TO SUBSECTIONS
(2), (3), AND (5) OF THIS SECTION FOR ITS
MEMBERS IN
COLORADO.
(10) T
HE COMMISSIONER SHALL PROMULGATE RULES TO IMPLEMENT
AND ENFORCE THIS SECTION
.
SECTION 7. In Colorado Revised Statutes, add 25.5-5-513 as
PAGE 13-HOUSE BILL 22-1370 follows:
25.5-5-513. Pharmacy benefits - prescription drugs - rebates -
analysis. (1) B
EGINNING IN 2023, THE STATE DEPARTMENT SHALL , IN
COLLABORATION WITH THE ADMINISTRATOR OF THE ALL
-PAYER HEALTH
CLAIMS DATABASE DESCRIBED IN SECTION
25.5-1-204, CONDUCT AN ANNUAL
ANALYSIS OF THE PRESCRIPTION DRUG REBATES RECEIVED IN THE PREVIOUS
CALENDAR YEAR
, BY HEALTH INSURANCE CARRIER AND PRESCRIPTION DRUG
TIER
. THE ANALYSIS, USING DATA FROM THE ALL-PAYER HEALTH CLAIMS
DATABASE AND OTHER SOURCES
, MUST BE COMPLETED ON OR BEFORE MAY
1 OF EACH YEAR.
(2) T
HE STATE DEPARTMENT SHALL MAKE THE ANALYSIS
CONDUCTED IN SUBSECTION
(1) OF THIS SECTION AVAILABLE TO THE PUBLIC
ON AN ANNUAL BASIS
.
SECTION 8. Appropriation. (1) For the 2022-23 state fiscal year,
$252,667 is appropriated to the department of regulatory agencies for use
by the division of insurance. This appropriation is from the division of
insurance cash fund created in section 10-1-103 (3), C.R.S. To implement
this act, the division may use this appropriation as follows:
(a) $237,972 for personal services, which amount is based on an
assumption that the division will require an additional 1.7 FTE; and
(b) $14,695 for operating expenses.
SECTION 9. Act subject to petition - effective date -
applicability. (1) This act takes effect at 12:01 a.m. on the day following
the expiration of the ninety-day period after final adjournment of the
general assembly; except that, if a referendum petition is filed pursuant to
section 1 (3) of article V of the state constitution against this act or an item,
section, or part of this act within such period, then the act, item, section, or
part will not take effect unless approved by the people at the general
election to be held in November 2022 and, in such case, will take effect on
the date of the official declaration of the vote thereon by the governor.
(2) Section 1 of this act applies to health benefit plans issued or
renewed on or after January 1, 2023.
PAGE 14-HOUSE BILL 22-1370 (3) Sections 2 through 6 of this act apply to health benefit plans
issued or renewed on or after January 1, 2024.
____________________________ ____________________________
Alec Garnett Steve Fenberg
SPEAKER OF THE HOUSE PRESIDENT OF
OF REPRESENTATIVES THE SENATE
____________________________ ____________________________
Robin Jones Cindi L. Markwell
CHIEF CLERK OF THE HOUSE SECRETARY OF
OF REPRESENTATIVES THE SENATE
APPROVED________________________________________
(Date and Time)
_________________________________________
Jared S. Polis
GOVERNOR OF THE STATE OF COLORADO
PAGE 15-HOUSE BILL 22-1370