HOUSE BILL 22-1370 BY REPRESENTATIVE(S) Jodeh and Sirota

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.

CONCERNING

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)

IN

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

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)

FOR

EACH

COPAYMENT-ONLY

PAYMENT

STRUCTURE

FOR

PRESCRIPTIONS

DRUGS:

(I)

THE

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)

THE

COPAYMENT

AMOUNTS

BETWEEN

THE

TWO

HIGHEST

PRESCRIPTION

DRUG

COST

TIERS

MUST

HAVE

A

COST

DIFFERENCE

OF

AT

LEAST

TEN

PERCENT;

(III)

No

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)

THE

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)

STARTING

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)

REMOVE

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)

THE

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)

MOVE

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)

APPROVED

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)

REMOVE

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)

THE

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)

THIS

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)

THE

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)

AS

USED

IN

THIS

SECTION:

(a)

"BIOSIMILAR"

HAS

THE

MEANING

SET

FORTH

IN

42

U.S.C.

SEC.

262

(i)(2).

(b)

"CLINICAL

PRACTICE

GUIDELINES"

ME

ANS

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

DETERMINE

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)

"EXIGENT

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)

"MEDICAL

NECESSITY"

HAS

THE

SAME

MEANING

AS

SET

FORTH

IN

SECTION

10-16-112.5.

(f)

"PRIVATE

UTILIZATION

REVIEW

ORGANIZATION"

OR

"ORGANIZATION"

HAS

THE

SAME

MEANING

AS

SET

FORTH

IN

SECTION

10-16-112

(1)(a).

(g)

"STEP

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)

IF

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)

MAKE

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)

THE

PROVIDER

ATTESTS

THAT

THE

REQUIRED

PRESCRIPTION

DRUG

IS

CONTRAINDICATED

OR

WILL

LIKELY

CAUSE

AN

ADVERSE

REACTION

OR

HARM

TO

THE

COVERED

PERSON;

(II)

THE

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)

THE

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)

THE

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)

EXCEPT

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)

THREE

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)

IF

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)

IF

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)

THIS

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)

THE

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

and

g

adiilinistratiuix

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

Unitcd

Statcs

food

and

tug

administration-appruvcd

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)

Forthe-purpases-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

stcp-thcrapy

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.

(

-

17

-

Y7kr

-

used

-

hrthis

-

subsectiorr

(117'stage

-

follr

advanccd

-

rnetastatie

cancer"

mcans

cancer

that

has

sprcad

from

thc

primary

or

original

sitc

of

the

caneerter

nearbrtissuesTlYmPiritodes

-

,

-

or

tither

Parts•Trfthe

-

botir

(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

(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.

,

"atypical

opioid"

liicalls

PAGE

9

-HOUSE

BILL

22-1370

rtgorrist--witir-a--documented--safer-sid-e-effeet-praffle-and-l

-

en-risk—af

ad-dietioir

than-erbier-opittm-baseci-medieations

-

:

(3)

AS

USED

IN

THIS

SECTION:

(a)

"ATYPICAL

OPIOID"

MEANS

AN

OPIOID

AGONIST

WITH

A

DOCUMENTED

SAFER

SIDE

-EFFECT

PROFILE

AND

LESS

RISK

OF

ADDICTION

THAN

OLDER

OPIUM

-BASED

MEDICATIONS.

(b)

"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.

(c)

"STEP

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)

As

USED

IN

THIS

SECTION,

UNLESS

THE

CONTEXT

OTHERWISE

REQUIRES:

(a)

"DISCOUNT"

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)

"HEALTH

INSURER"

MEANS

A

CARRIER:

(I)

AS

DEFINED

IN

SECTION

10-16-102

(8);

AND

(II)

AS

DEFINED

IN

SECTION

24-50-603

(2).

(c)

"MANUFACTURER"

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)

"REBATE"

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)

FOR

EACH

HEALTH

BENEFIT

PLAN

ISSUED

OR

RENEWED

ON

OR

AFTER

JANUARY

1,

2024,

A

HEALTH

INSURER

SHALL

ENSURE

THAT

ONE

HUNDRED

PERCENT

OF

DISCOUNTS

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)

FOR

EACH

HEALTH

BENEFIT

PLAN

ISSUED

OR

RENEWED

ON

OR

AFTER

JANUARY

1,

2024,

A

HEALTH

INSURER

SHALL

ENSURE

THAT:

(a)

ONE

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)

FOR

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)

INCREASE

PREMIUMS;

(II)

CHANGE

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)

ON

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)

PREMIUM

IMPACTS;

(II)

CHANGES

IN

THE

PLAN'S

ACTUARIAL

VALUE;

AND

(III)

OTHER

POTENTIAL

IMPACTS

TO

CONSUMERS.

(b)

REGARDLESS

OF

THE

RESULTS

OF

THE

STUDY,

A

HEALTH

INSURER

SHALL

COMPLY

WITH

SUBSECTION

(3)

OF

THIS

SECTION.

(c)

THE

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)

EACH

HEALTH

INSURER

SHALL

REPORT

ANNUALLY:

(a)

IN

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)

AN

ACTUARIAL

CERTIFICATION

THAT

ATTESTS

THAT:

(I)

THE

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)

THE

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)

INFORMATION

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)

THIS

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)

THE

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)

THE

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)

BEGINNING

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)

THE

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

SPEAKER

OF

THE

HOUSE

OF

REPRESENTATIVES

Robin

Jones

CHIEF

CLERK

OF

THE

SE

OF

REPRESENTATIVES

APPROVED

Steve

Fenberg

PRESIDENT

OF

THE

SENATE

64:0LONTIO4

1

.

04

-

11

--k-

Cindi

L.

Mark

-

well

SECRETARY

OF

THE

SENATE

/0

Date

and

Tim

Jared

GO

.

Polis

RNO

OF

THE

STATE

0

SOLORADO

PAGE

15

-HOUSE

BILL

22-1370