HOUSE BILL 22-1122
BY REPRESENTATIVE(S) Will and Lindsay, Lontine, Bernett, Esgar,
Jodeh, Kipp, Ricks, Weissman, Daugherty, Hooton;
also SENATOR(S) Jaquez Lewis, Moreno.
C
ONCERNING PROHIBITING CERTAIN PRACTICES BY ENTITIES OBLIGATED TO
PAY FOR PRESCRIPTION DRUG BENEFITS
, 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 part 15 to article
16 of title 10 as follows:
PART 15
340B PRESCRIPTION DRUG PROGRAM
ANTI-DISCRIMINATION ACT
10-16-1501. Short title. T
HE SHORT TITLE OF THIS PART 15 IS THE
"COLORADO 340B PRESCRIPTION DRUG PROGRAM ANTI-DISCRIMINATION
ACT".
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. 10-16-1502. Legislative declaration. (1) T HE GENERAL ASSEMBLY
DECLARES THAT THE PURPOSE OF THIS PART
15 IS TO:
(a) P
ROHIBIT A PHARMACY BENEFIT MANAGER OR CARRIER FROM
IMPOSING FEES
, CHARGE BACKS, OR OTHER ADJUSTMENTS ON COVERED
ENTITIES OR CONTRACT PHARMACIES BASED ON THEIR PARTICIPATION IN THE
340B DRUG PRICING PROGRAM;
(b) P
ROHIBIT A PHARMACY BENEFIT MANAGER OR CARRIER FROM
REQUIRING A CLAIM FOR A DRUG TO INCLUDE A MODIFIER TO INDICATE THAT
THE DRUG IS A
340B DRUG UNLESS THE CLAIM IS FOR PAYMENT , DIRECTLY
OR INDIRECTLY
, BY THE MEDICAID PROGRAM; AND
(c) PROVIDE FOR POWERS AND DUTIES OF THE COMMISSIONER AND
THE DIVISION
.
10-16-1503. Definitions. A
S USED IN THIS PART 15, UNLESS THE
CONTEXT OTHERWISE REQUIRES
:
(1) "340B
COVERED ENTITY" MEANS A COVERED ENTITY, AS DEFINED
IN SECTION
340B (a)(4) OF THE FEDERAL "PUBLIC HEALTH SERVICE ACT",
42
U.S.C. SEC. 256b (a)(4), AS AMENDED.
(2) "340B
DRUG" MEANS A DRUG PURCHASED THROUGH THE 340B
DRUG PRICING PROGRAM BY A 340B COVERED ENTITY.
(3) "340B
DRUG PRICING PROGRAM" OR "340B PROGRAM" MEANS
THE PROGRAM DESCRIBED IN
42 U.S.C. SEC. 256b.
(4) "C
ONTRACT PHARMACY" MEANS A PHARMACY OPERATING UNDER
CONTRACT WITH A
340B COVERED ENTITY TO PROVIDE DISPENSING SERVICES
TO THE
340B COVERED ENTITY AS DESCRIBED IN 75 FED. REG. 10272 (2010)
OR ANY SUPERSEDING GUIDANCE .
(5) (a) "D
RUG COVERAGE" MEANS COVERAGE OR PAYMENT FOR A
PRESCRIPTION DRUG DISPENSED BY A PHARMACY TO A PATIENT PURSUANT
TO
:
(I) A
HEALTH COVERAGE PLAN;
PAGE 2-HOUSE BILL 22-1122 (II) A MANAGED CARE ORGANIZATION , AS DEFINED IN SECTION
25.5-5-403 (5); OR
(III) ANY OTHER CONTRACTUAL OR OTHER LEGAL OBLIGATION TO
PROVIDE COVERAGE OR PAYMENT FO R A PRESCRIPTION DRUG DISPENSED BY
A PHARMACY TO A PATIENT
.
(b) "D
RUG COVERAGE" DOES NOT INCLUDE:
(I) R
EIMBURSEMENT FOR COVERED OUTPATIENT DRUGS , AS THAT
TERM IS DEFINED IN SECTION
42 U.S.C. SEC. 1396r-8 (k)(2), ON A
FEE
-FOR-SERVICE BASIS UNDER THE MEDICAID PROGRAM ; OR
(II) ANY AMOUNTS PAID BY AN INDIVIDUAL ON THE INDIVIDUAL 'S
OWN BEHALF OR ON BEHALF OF ANOTHER INDIVIDUAL WITHOUT A
CONTRACTUAL OR LEGAL OBLIGATION TO DO SO
.
(6) "M
EDICAID PROGRAM" MEANS THE MEDICAL ASSISTANCE
PROGRAM ESTABLISHED PURSUANT TO ARTICLES
4 TO 6 OF TITLE 25.5.
(7) (a) "T
HIRD PARTY" MEANS:
(I) A
CARRIER OR PHARMACY BENEFIT MANAGER THAT PROVIDES OR
MANAGES DRUG COVERAGE UNDER A HEALTH COVERAGE PLAN
; OR
(II) A SYSTEM OF HEALTH INSURANCE FOR STATE OR LOCAL
GOVERNMENT EMPLOYEES
, THEIR DEPENDENTS, AND RETIREES, INCLUDING
A GROUP BENEFIT PLAN
, AS DEFINED IN SECTION 24-50-603 (9), AND A GROUP
HEALTH CARE PROGRAM DESIGNED PURSUANT TO SECTION
24-51-1202.
(b) "T
HIRD PARTY" DOES NOT INCLUDE:
(I) A
N INSURER THAT PROVIDES COVERAGE UNDER A POLICY OF
PROPERTY AND CASUALTY INSURANCE
; OR
(II) AN INSURER OR ENTITY THAT PROVIDES HEALTH COVERAGE ,
BENEFITS, OR COVERAGE OF PRESCRIPTION DRUGS AS PART OF COVERAGE
REQUIRED UNDER THE
"WORKERS' COMPENSATION ACT OF COLORADO",
ARTICLES 40 TO 47 OF TITLE 8, OR WORKERS' COMPENSATION COVERAGE
REQUIRED UNDER FEDERAL LAW
.
PAGE 3-HOUSE BILL 22-1122 10-16-1504. Applicability - exclusions. (1) T HIS PART 15 APPLIES
TO ANY THIRD PARTY THAT REIMBURSES
340B COVERED ENTITIES OR
CONTRACT PHARMACIES IN THIS STATE
.
(2) N
OTHING IN THIS PART 15:
(a) P
ROHIBITS A THIRD PARTY FROM MAINTAINING DIFFERENTIAL
REIMBURSEMENT RATES FOR PARTICIPATING AND NONPARTICIPATING
PROVIDERS
, SO LONG AS THE RATES ARE NOT DETERMINED ON THE BASIS OF
A PROVIDER
'S STATUS AS A 340B COVERED ENTITY OR CONTRACT
PHARMACY
;
(b) A
FFECTS A THIRD PARTY'S ABILITY TO ESTABLISH COVERAGE
GUIDELINES AND EXCLUDE SPECIFIC DRUGS FROM ITS PRESCRIPTION DRUG
FORMULARIES
, SO LONG AS THE GUIDELINES AND EXCLUSIONS ARE NOT
DETERMINED ON THE BASIS OF A PROVIDER
'S STATUS AS A 340B COVERED
ENTITY OR CONTRACT PHARMACY OR OF A DRUG
'S STATUS AS A 340B DRUG;
OR
(c) REQUIRES A THIRD PARTY TO CONTRACT WITH A 340B COVERED
ENTITY OR CONTRACT PHARMACY FOR PURPOSES OF PARTICIPATING IN THE
THIRD PARTY
'S NETWORK, SO LONG AS THE THIRD PARTY'S CONTRACTING
DECISIONS ARE NOT DETERMINED ON THE BASIS OF A PROVIDER
'S STATUS AS
A
340B COVERED ENTITY OR CONTRACT PHARMACY .
10-16-1505. Prohibition on 340B discrimination. (1) A
THIRD
PARTY THAT REIMBURSES A
340B COVERED ENTITY OR CONTRACT
PHARMACY FOR
340B DRUGS SHALL NOT:
(a) R
EIMBURSE THE 340B COVERED ENTITY OR CONTRACT
PHARMACY FOR A PHARMACY
-DISPENSED DRUG AT A RATE LOWER THAN THE
AMOUNT PAID FOR THE SAME DRUG TO PHARMACIES SIMILAR IN
PRESCRIPTION VOLUME THAT ARE NOT
340B COVERED ENTITIES OR
CONTRACT PHARMACIES
;
(b) A
SSESS ANY FEE, CHARGE BACK, OR OTHER ADJUSTMENT
AGAINST THE
340B COVERED ENTITY OR CONTRACT PHARMACY ON THE
BASIS THAT THE
340B COVERED ENTITY OR CONTRACT PHARMACY
PARTICIPATES IN THE
340B PROGRAM;
PAGE 4-HOUSE BILL 22-1122 (c) RESTRICT ACCESS TO THE THIRD PARTY'S PHARMACY NETWORK
FOR ANY
340B COVERED ENTITY OR CONTRACT PHARMACY ON THE BASIS
THAT THE
340B COVERED ENTITY OR CONTRACT PHARMACY PARTICIPATES
IN THE
340B PROGRAM;
(d) R
EQUIRE THE 340B COVERED ENTITY OR CONTRACT PHARMACY
TO ENTER INTO A CONTRACT WITH A SPECIFIC PHARMACY OR HEALTH
COVERAGE PLAN TO PARTICIPATE IN THE THIRD PARTY
'S PHARMACY
NETWORK
;
(e) C
REATE A RESTRICTION OR AN ADDITIONAL CHARGE ON A
PATIENT WHO CHOOSES TO RECEIVE DRUGS FROM A
340B COVERED ENTITY
OR CONTRACT PHARMACY
;
(f) R
ESTRICT THE METHODS BY WHICH A 340B COVERED ENTITY OR
CONTRACT PHARMACY MAY DISPENSE OR DELIVER
340B DRUGS;
(g) R
EFUSE TO PROVIDE REIMBURSEMENT OR COVERAGE FOR 340B
DRUGS; OR
(h) CREATE ANY ADDITIONAL REQUIREMENTS OR RESTRICTIONS ON
A
340B COVERED ENTITY OR CONTRACT PHARMACY .
(2) U
NLESS A CLAIM IS FOR PAYMENT, DIRECTLY OR INDIRECTLY, BY
THE MEDICAID PROGRAM
, A PHARMACY BENEFIT MANAGER OR ANY OTHER
THIRD PARTY THAT REIMBURSES A
340B COVERED ENTITY OR CONTRACT
PHARMACY FOR
340B DRUGS SHALL NOT REQUIRE A CLAIM FOR A 340B
DRUG TO INCLUDE:
(a) A
MODIFIER TO INDICATE THAT THE DRUG IS A 340B DRUG; OR
(b) ANY OTHER METHOD OF IDENTIFYING THE CLAIM FOR A 340B
DRUG.
(3) W
ITH RESPECT TO A PATIENT ELIGIBLE TO RECEIVE 340B DRUGS,
A PHARMACY BENEFIT MANAGER OR ANY OTHER THIRD PARTY THAT MAKES
PAYMENT FOR THE DRUGS SHALL NOT DISCRIMINATE AGAINST A
340B
COVERED ENTITY OR CONTRACT PHARMACY IN A MANNER THAT PREVENTS
OR INTERFERES WITH THE PATIENT
'S CHOICE TO RECEIVE THE DRUGS FROM
THE
340B COVERED ENTITY OR CONTRACT PHARMACY .
PAGE 5-HOUSE BILL 22-1122 10-16-1506. Enforcement - rules. (1) A THIRD PARTY THAT
VIOLATES THIS PART
15 ENGAGES IN AN UNFAIR OR DECEPTIVE ACT OR
PRACTICE IN THE BUSINESS OF INSURANCE UNDER SECTION
10-3-1104 (1)(tt),
AND THE ACT OF THE THIRD PARTY THAT VIOLATES THIS PART 15 IS VOID AND
UNENFORCEABLE
.
(2) T
HE COMMISSIONER MAY ADOPT RULES AS NECESSARY TO
IMPLEMENT THIS PART
15.
SECTION 2. In Colorado Revised Statutes, 10-3-1104, add (1)(tt)
as follows:
10-3-1104. Unfair methods of competition - unfair or deceptive
practices. (1) The following are defined as unfair methods of competition
and unfair or deceptive acts or practices in the business of insurance:
(tt) A
VIOLATION OF PART 15 OF ARTICLE 16 OF THIS TITLE 10.
SECTION 3. Appropriation. For the 2022-23 state fiscal year,
$17,109 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., and is based on
an assumption that the division will require an additional 0.3 FTE. To
implement this act, the division may use this appropriation for personal
services.
SECTION 4. Act subject to petition - effective date. 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
PAGE 6-HOUSE BILL 22-1122 November 2022 and, in such case, will take effect on the date of the official
declaration of the vote thereon by the governor.
____________________________ ____________________________
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 7-HOUSE BILL 22-1122