Second Regular Session Seventy-third General Assembly STATE OF COLORADO INTRODUCED LLS NO. 22-0243.02 Christy Chase x2008 HOUSE BILL 22-1122 House Committees Senate Committees Health & Insurance A BILL FOR AN ACT C ONCERNING PROHIBITING CERT AIN PRACTICES BY ENTITIES101 OBLIGATED TO PAY FOR PR ESCRIPTION DRUG BENEFITS .102 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 .) For contracts between a pharmacy benefit manager (PBM) and a pharmacy entered into or renewed on or after January 1, 2023, section 1 of the bill prohibits the PBM or its representative from reimbursing a pharmacy for a prescription drug in an amount less than the national average drug acquisition cost for the prescription drug. Section 2 enacts the "Colorado 340B Prescription Drug Program HOUSE SPONSORSHIP Will, Lontine SENATE SPONSORSHIP Jaquez Lewis, 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. Anti-discrimination Act" (act), which prohibits health insurers, PBMs, and other third-party payers (third-party payers) from discriminating against entities, including pharmacies, participating in the federal 340B drug pricing program (340B covered entity). Specifically, the bill prohibits a third-party payer from: ! Refusing to reimburse a 340B covered entity for dispensing 340B drugs, imposing additional requirements or restrictions on 340B covered entities, or reimbursing a 340B covered entity for a 340B drug at a rate lower than the amount paid for the same drug to pharmacies that are not 340B covered entities; ! Assessing a fee, charge back, or other adjustment against a 340B covered entity, or restricting a 340B covered entity's access to the third-party payer's pharmacy network, because the covered entity participates in the 340B drug pricing program; ! Requiring a 340B covered entity to contract with a specific pharmacy or health coverage plan in order to access the third-party payer's pharmacy network; ! Imposing a restriction or an additional charge on a patient who obtains a prescription drug from a 340B covered entity; or ! Restricting the methods by which a 340B covered entity may dispense or deliver 340B drugs. Section 2 makes a violation of the act an unfair or deceptive act or practice in the business of insurance and authorizes the commissioner of insurance to adopt rules to implement the act. Be it enacted by the General Assembly of the State of Colorado:1 SECTION 1. In Colorado Revised Statutes, 10-16-122.1, add2 (3.5), (5)(a.5), and (5)(h) as follows:3 10-16-122.1. Contracts between PBMs and pharmacies -4 carrier submit list of PBMs - prohibited practices - exception - short5 title - definitions. (3.5) F OR ANY CONTRACT BETWEEN A PBM AND A6 PHARMACY ENTERED INTO OR RENEWED ON OR AFTER JANUARY 1, 2023,7 A PBM OR THE REPRESENTATIVE OF A PBM SHALL NOT REIMBURSE A8 PHARMACY FOR A PRESCRIPTION DRUG IN AN AMOUNT THAT IS LESS THAN :9 (a) T HE NATIONAL AVERAGE DRUG ACQUISITION COST FOR THE10 HB22-1122-2- PRESCRIPTION DRUG AT THE TIME THE DRUG IS ADMINISTERED OR1 DISPENSED, PLUS A PROFESSIONAL DISPENSING FEE; OR2 (b) I F THE NATIONAL AVERAGE DRUG ACQUISITION COST IS NOT3 AVAILABLE AT THE TIME A PRESCRIPTION DRUG IS ADMINISTERED OR4 DISPENSED, THE WHOLESALE ACQUISITION COST OF THE DRUG , PLUS A5 PROFESSIONAL DISPENSING FEE.6 (5) As used in this section and section 10-16-122.9, unless the7 context otherwise requires:8 (a.5) "N ATIONAL AVERAGE DRUG ACQUISITION COST " MEANS THE9 DRUG PRICING BENCHMARK DEVELOPED BY THE FEDERAL CENTERS FOR10 MEDICARE AND MEDICAID SERVICES IN THE UNITED STATES DEPARTMENT11 OF HEALTH AND HUMAN SERVICES , WHICH BENCHMARK IS BASED ON DATA12 COLLECTED FROM A MONTHLY NATIONWIDE SURVEY OF RETAIL13 COMMUNITY PHARMACY OUTPATIENT DRUG PRICES .14 (h) "W HOLESALE ACQUISITION COST " HAS THE MEANING SET15 FORTH IN 42 U.S.C. SEC. 1395w-3a (c)(6)(B).16 SECTION 2. In Colorado Revised Statutes, add part 15 to article17 16 of title 10 as follows:18 PART 1519 340B PRESCRIPTION DRUG PROGRAM 20 ANTI-DISCRIMINATION ACT 21 10-16-1501. Short title. T HE SHORT TITLE OF THIS PART 15 IS THE22 "C OLORADO 340B PRESCRIPTION DRUG PROGRAM ANTI-DISCRIMINATION23 A CT".24 10-16-1502. Legislative declaration. (1) T HE GENERAL25 ASSEMBLY DECLARES THAT THE PURPOSE OF THIS PART 15 IS TO:26 (a) P ROHIBIT A PHARMACY BENEFIT MANAGER OR CARRIER FROM27 HB22-1122 -3- IMPOSING FEES, CHARGE BACKS, OR OTHER ADJUSTMENTS ON COVERED1 ENTITIES OR CONTRACT PHARMACIES BASED ON THEIR PARTICIPATION IN2 THE 340B DRUG PRICING PROGRAM;3 (b) P ROHIBIT A PHARMACY BENEFIT MANAGER OR CARRIER FROM4 REQUIRING A CLAIM FOR A DRUG TO INCLUDE A MODIFIER TO INDICATE5 THAT THE DRUG IS A 340B DRUG UNLESS THE CLAIM IS FOR PAYMENT ,6 DIRECTLY OR INDIRECTLY, BY THE MEDICAID PROGRAM; AND7 (c) P ROVIDE FOR POWERS AND DUTIES OF THE COMMISSIONER AND8 THE DIVISION.9 10-16-1503. Definitions. A S USED IN THIS PART 15, UNLESS THE10 CONTEXT OTHERWISE REQUIRES :11 (1) "340B COVERED ENTITY" MEANS A COVERED ENTITY , AS12 DEFINED IN SECTION 340B (a)(4) OF THE FEDERAL "PUBLIC HEALTH13 S ERVICE ACT", 42 U.S.C. SEC. 256b (a)(4), AS AMENDED. "340B COVERED14 ENTITY" INCLUDES A PHARMACY UNDER CONTRACT WITH A 340B COVERED15 ENTITY TO DISPENSE DRUGS ON BEHALF OF THE ENTITY .16 (2) "340B DRUG" MEANS A DRUG PURCHASED THROUGH THE 340B17 DRUG PRICING PROGRAM BY A 340B COVERED ENTITY.18 (3) "340B DRUG PRICING PROGRAM" OR "340B PROGRAM" MEANS19 THE PROGRAM DESCRIBED IN 42 U.S.C. SEC. 256b.20 (4) "C ONTRACT PHARMACY " MEANS A PHARMACY OPERATING21 UNDER CONTRACT WITH A 340B COVERED ENTITY TO PROVIDE DISPENSING22 SERVICES TO THE 340B COVERED ENTITY AS DESCRIBED IN 75 FED. REG.23 10272 (2010) OR ANY SUPERSEDING GUIDANCE .24 (5) (a) "D RUG COVERAGE" MEANS COVERAGE OR PAYMENT FOR A 25 PRESCRIPTION DRUG DISPENSED BY A PHARMACY TO A PATIENT PURSUANT26 TO:27 HB22-1122 -4- (I) A HEALTH COVERAGE PLAN; 1 (II) A MANAGED CARE ORGANIZATION , AS DEFINED IN SECTION2 25.5-5-403 (5); OR3 (III) A NY OTHER CONTRACTUAL OR OTHER LEGAL OBLIGATION TO4 PROVIDE COVERAGE OR PAYMENT FOR A PRESCRIPTION DRUG DISPENSED5 BY A PHARMACY TO A PATIENT.6 (b) "D RUG COVERAGE" DOES NOT INCLUDE:7 (I) R EIMBURSEMENT FOR COVERED OUTPATIENT DRUGS , AS THAT8 TERM IS DEFINED IN SECTION 42 U.S.C. SEC. 1396r-8 (k)(2), ON A9 FEE-FOR-SERVICE BASIS UNDER THE MEDICAID PROGRAM ; OR10 (II) A NY AMOUNTS PAID BY AN INDIVIDUAL ON THE INDIVIDUAL 'S11 OWN BEHALF OR ON BEHALF OF ANOTHER INDIVIDUAL WITHOUT A12 CONTRACTUAL OR LEGAL OBLIGATION TO DO SO .13 (6) "MEDICAID PROGRAM" MEANS THE MEDICAL ASSISTANCE14 PROGRAM ESTABLISHED PURSUANT TO ARTICLES 4 TO 6 OF TITLE 25.5.15 (7) (a) "T HIRD PARTY" MEANS:16 (I) A CARRIER OR PHARMACY BENEFIT MANAGER THAT PROVIDES17 OR MANAGES DRUG COVERAGE UNDE R A HEALTH COVERAGE PLAN ;18 (II) A SYSTEM OF HEALTH INSURANCE FOR STATE OR LOCAL19 GOVERNMENT EMPLOYEES , THEIR DEPENDENTS, AND RETIREES, INCLUDING20 A GROUP BENEFIT PLAN, AS DEFINED IN SECTION 24-50-603 (9), AND A21 GROUP HEALTH CARE PROGRAM DESIGNED PURSUANT TO SECTION22 24-51-1202; OR23 (III) A NY OTHER INSURER OR ENTITY THAT PROVIDES HEALTH24 COVERAGE, BENEFITS, OR COVERAGE OF PRESCRIPTION DRUGS AS PART OF25 COVERAGE REQUIRED UNDER THE "WORKERS' COMPENSATION ACT OF26 C OLORADO", ARTICLES 40 TO 47 OF TITLE 8, OR WORKERS' COMPENSATION27 HB22-1122 -5- COVERAGE REQUIRED UNDER FEDERAL LAW .1 (b) "T HIRD PARTY" DOES NOT INCLUDE AN INSURER THAT2 PROVIDES COVERAGE UNDER A POLICY OF PROPERTY AND CASUALTY3 INSURANCE.4 10-16-1504. Applicability. T HIS PART 15 APPLIES TO ANY THIRD5 PARTY PROVIDING OR MANAGING DRUG COVERAGE UNDER A HEALTH6 COVERAGE PLAN IN THIS STATE.7 10-16-1505. Prohibition on 340B discrimination. (1) A THIRD8 PARTY THAT REIMBURSES A 340B COVERED ENTITY FOR 340B DRUGS9 SHALL NOT:10 (a) R EIMBURSE THE 340B COVERED ENTITY FOR A11 PHARMACY-DISPENSED DRUG AT A RATE LOWER THAN THE AMOUNT PAID12 FOR THE SAME DRUG TO PHARMACIES SIMILAR IN PRESCRIPTION VOLUME13 THAT ARE NOT 340B COVERED ENTITIES;14 (b) A SSESS ANY FEE, CHARGE BACK, OR OTHER ADJUSTMENT15 AGAINST THE 340B COVERED ENTITY ON THE BASIS THAT THE 340B16 COVERED ENTITY PARTICIPATES IN THE 340B PROGRAM;17 (c) R ESTRICT ACCESS TO THE THIRD PARTY'S PHARMACY NETWORK18 FOR ANY 340B COVERED ENTITY ON THE BASIS THAT THE 340B COVERED19 ENTITY PARTICIPATES IN THE 340B PROGRAM;20 (d) R EQUIRE THE 340B COVERED ENTITY TO ENTER INTO A21 CONTRACT WITH A SPECIFIC PHARMACY OR HEALTH COVERAGE PLAN TO22 PARTICIPATE IN THE THIRD PARTY'S PHARMACY NETWORK ;23 (e) C REATE A RESTRICTION OR AN ADDITIONAL CHARGE ON A24 PATIENT WHO CHOOSES TO RECEIVE DRUGS FROM A 340B COVERED25 ENTITY; 26 (f) R ESTRICT THE METHODS BY WHICH A 340B COVERED ENTITY27 HB22-1122 -6- MAY DISPENSE OR DELIVER 340B DRUGS;1 (g) R EFUSE TO PROVIDE REIMBURSEMENT OR COVERAGE FOR 340B2 DRUGS; OR3 (h) C REATE ANY ADDITIONAL REQUIREMENTS OR RESTRICTIONS ON4 A 340B COVERED ENTITY.5 (2) U NLESS A CLAIM IS FOR PAYMENT, DIRECTLY OR INDIRECTLY,6 BY THE MEDICAID PROGRAM , A PHARMACY BENEFIT MANAGER OR ANY7 OTHER THIRD PARTY THAT REIMBURSES A 340B COVERED ENTITY FOR8 340B DRUGS SHALL NOT REQUIRE A CLAIM FOR A 340B DRUG TO INCLUDE:9 (a) A MODIFIER TO INDICATE THAT THE DRUG IS A 340B DRUG; OR10 (b) A NY OTHER METHOD OF IDENTIFYING THE CLAIM FOR A 340B11 DRUG.12 (3) W ITH RESPECT TO A PATIENT ELIGIBLE TO RECEIVE 340B13 DRUGS, A PHARMACY BENEFIT MANAGER OR ANY OTHER THIRD PARTY14 THAT MAKES PAYMENT FOR THE DRUGS SHALL NOT DISCRIMINATE15 AGAINST A 340B COVERED ENTITY IN A MANNER THAT PREVENTS OR16 INTERFERES WITH THE PATIENT'S CHOICE TO RECEIVE THE DRUGS FROM17 THE 340B COVERED ENTITY. 18 10-16-1506. Enforcement - rules. (1) A THIRD PARTY THAT19 VIOLATES THIS PART 15 ENGAGES IN AN UNFAIR OR DECEPTIVE ACT OR20 PRACTICE IN THE BUSINESS OF INSURANCE UNDER SECTION 10-3-110421 (1)(tt), AND THE ACT OF THE THIRD PARTY THAT VIOLATES THIS PART 15 22 IS VOID AND UNENFORCEABLE.23 (2) T HE COMMISSIONER MAY ADOPT RULES AS NECESSARY TO24 IMPLEMENT THIS PART 15. 25 SECTION 3. In Colorado Revised Statutes, 10-3-1104, add26 (1)(tt) as follows:27 HB22-1122 -7- 10-3-1104. Unfair methods of competition - unfair or deceptive1 practices. (1) The following are defined as unfair methods of2 competition and unfair or deceptive acts or practices in the business of3 insurance:4 (tt) A VIOLATION OF PART 15 OF ARTICLE 16 OF THIS TITLE 10.5 SECTION 4. Act subject to petition - effective date. This act6 takes effect at 12:01 a.m. on the day following the expiration of the7 ninety-day period after final adjournment of the general assembly; except8 that, if a referendum petition is filed pursuant to section 1 (3) of article V9 of the state constitution against this act or an item, section, or part of this10 act within such period, then the act, item, section, or part will not take11 effect unless approved by the people at the general election to be held in12 November 2022 and, in such case, will take effect on the date of the13 official declaration of the vote thereon by the governor.14 HB22-1122 -8-