EXPLANATION-Matter enclosed in bold-faced brackets [thus] in this bill is not enacted and is intended to be omitted in the law. FIRST REGULAR SESSION SENATE BILL NO. 512 103RD GENERAL ASSEMBLY INTRODUCED BY SENATOR BERNSKOETTER. 1799S.01I KRISTINA MARTIN, Secretary AN ACT To repeal sections 338.015, 376.387, and 376.388, RSMo, and to enact in lieu thereof four new sections relating to payments for prescription drugs. Be it enacted by the General Assembly of the State of Missouri, as follows: Section A. Sections 338.015, 376.387, and 376.388, RSMo, 1 are repealed and four new sections enacted in lieu thereof, to 2 be known as sections 338.015, 376.387, 376.388, and 376.448, to 3 read as follows:4 338.015. 1. The provisions of sections 338.010 to 1 338.015 shall not be construed to inhibit the patient's 2 freedom of choice to obtain prescription services from any 3 licensed pharmacist or pharmacy. [However, nothing in 4 sections 338.010 to 338.315 abrogates the patient's ability 5 to waive freedom of choice under any contract with regard to 6 payment or coverage of prescription expense. ] 7 2. All pharmacists may provide pharmaceuti cal 8 consultation and advice to persons concerning the safe and 9 therapeutic use of their prescription drugs. 10 3. All patients shall have the right to receive a 11 written prescription from their prescriber to take to the 12 facility of their choice or to have an electronic 13 prescription transmitted to the facility of their choice. 14 4. No pharmacy benefits manager, as defined in section 15 376.388, shall prohibit or redirect by contract, or 16 otherwise penalize or restrict, a covered person, as defined 17 SB 512 2 in section 376.387, from obtaining any of the following from 18 a contracted pharmacy, as defined in section 376.388: 19 (1) Prescription services, including all prescriptions 20 covered by the covered person's health benefit plan; 21 (2) Consultation; or 22 (3) Advice. 23 376.387. 1. For purposes of this section, the 1 following terms shall mean: 2 (1) "Covered person", [the same meaning as such term 3 is defined in section 376.1257 ] a policyholder, subscriber, 4 enrollee, or other individual whose prescription drug 5 coverage is administered through a pharmacy benefits manager 6 or a health benefit plan ; 7 (2) "Health benefit plan", the same meaning as such 8 term is defined in section 376.1350; 9 (3) "Health carrier" or "carri er", the same meaning as 10 such term is defined in section 376.1350; 11 (4) "Pharmacy", the same meaning as such term is 12 defined in chapter 338; 13 (5) "Pharmacy benefits manager", the same meaning as 14 such term is defined in section 376.388 ; 15 (6) "Pharmacy benefits manager rebate aggregator", any 16 entity that negotiates with a pharmaceutical manufacturer on 17 behalf of a pharmacy benefits manager for a rebate; 18 (7) "Pharmacy claims data", information regarding a 19 prescription transaction tha t is adjudicated by a pharmacy 20 benefits manager for a covered person between the pharmacy 21 and the pharmacy benefits manager and between the pharmacy 22 benefits manager and the health benefit plan sponsor; 23 (8) "Rebate", any discount, negotiated conce ssion, or 24 other payment provided by a pharmaceutical manufacturer, 25 pharmacy, or health benefit plan to an entity to sell, 26 SB 512 3 provide, pay, or reimburse a pharmacy or other entity in the 27 state for the dispensation, coverage, or administration of a 28 prescription drug on behalf of itself or another entity . 29 2. No pharmacy benefits manager shall [include a 30 provision in a contract entered into or modified on or after 31 August 28, 2018, with a pharmacy or pharmacist that 32 requires] require a covered person to make a payment for a 33 prescription drug at the point of sale in an amount that 34 exceeds the lesser of: 35 (1) The copayment amount as required under the health 36 benefit plan; [or] 37 (2) The amount an individual would pay for a 38 prescription if that individual paid with cash ; or 39 (3) The amount equal to the difference of the final 40 reimbursement amount paid to the contracted pharmacy, as 41 defined in section 376.388, by the pharmacy benefits manager 42 for the prescription drug minus any rebate p aid, and any 43 amount paid or owed by the health benefit plan, for the 44 prescription drug. 45 3. A pharmacy or pharmacist shall have the right to : 46 (1) Provide to a covered person information regarding 47 the amount of the covered person's cost share for a 48 prescription drug, the covered person's cost of an 49 alternative drug, and the covered person's cost of the drug 50 without adjudicating the claim through the pharmacy benefits 51 manager. Neither a pharmacy nor a pharmacist shall be 52 proscribed by a pharmacy benefits manager from discussing 53 any such information or from selling a more affordable 54 alternative to the covered person ; and 55 (2) Provide to a health benefit plan sponsor any 56 information, including pharmacy claims data, related to the 57 SB 512 4 sponsor's health benefit plan except to the extent 58 prohibited by law. 59 4. (1) A pharmacy benefits manager shall not directly 60 or indirectly, including indirectly through a pharmacy 61 services administrative organization, reduce the amount of 62 the claim at the time of the claim's adjudication or after 63 the claim is adjudicated. 64 (2) A pharmacy benefits manager shall not directly or 65 indirectly, including indirectly through a pharmacy services 66 administrative organization, charge a pharmacy a fee rel ated 67 to the adjudication of a claim, including any fee related to: 68 (a) The receipt and processing of a pharmacy claim; 69 (b) The development or management of a claim 70 processing or adjudication network; or 71 (c) Participation in a claim proc essing or claim 72 adjudication network. 73 5. No pharmacy benefits manager shall, directly or 74 indirectly, charge or hold a pharmacist or pharmacy 75 responsible for any fee amount related to a claim that is 76 not known at the time of the claim's adjudicati on, unless 77 the amount is a result of improperly paid claims [or charges 78 for administering a health benefit plan ]. 79 [5. This section shall not apply with respect to 80 claims under Medicare Part D, or any other plan administered 81 or regulated solely un der federal law, and to the extent 82 this section may be preempted under the Employee Retirement 83 Income Security Act of 1974 for self -funded employer- 84 sponsored health benefit plans. ] 85 6. A pharmacy benefits manager shall notify in writing 86 any health carrier with which it contracts if the pharmacy 87 benefits manager has a conflict of interest, any commonality 88 of ownership, or any other relationship, financial or 89 SB 512 5 otherwise, between the pharmacy benefits manager and any 90 other health carrier with which the pharmacy benefits 91 manager contracts. 92 7. Any pharmacy benefits manager that enters into a 93 contract to sell, provide, pay, or reimburse a pharmacy in 94 the state for prescription drugs on behalf of itself or 95 another entity shall define and apply the term "generic", 96 with respect to prescription drugs, to mean any "authorized 97 generic drug", as defined in 21 CFR 314.3, approved under 98 Section 505(c) of the Federal Food, Drug, and Cosmetic Act, 99 as amended. 100 8. An entity shall define and apply the term "rebate" 101 as having the same meaning given to the term in this section 102 if the entity enters into a contract to sell, provide, pay, 103 negotiate rebates for, or reimburse a pharmacy, pharmacy 104 benefits manager, pharmacy benefits manager affiliate a s 105 defined in section 376.388, or pharmacy benefits manager 106 rebate aggregator for prescription drugs on behalf of itself 107 or another entity. 108 9. A pharmacy benefits manager that has contracted 109 with an entity to provide pharmacy benefits management 110 services for such an entity or any person who negotiates 111 with a pharmacy benefits manager on behalf of a purchaser of 112 health care benefits shall owe a fiduciary duty to that 113 entity or purchaser of health care benefits and shall 114 discharge that duty in a ccordance with federal and state law. 115 10. A pharmacy benefits manager shall have a duty to 116 disclose to a health benefit plan sponsor. As used in this 117 subsection, "duty to disclose" shall mean notifying the 118 health benefit plan sponsor of material facts and actions 119 taken by a pharmacy benefits manager related to the 120 SB 512 6 administration of the pharmacy benefits on behalf of the 121 health benefit plan sponsor that: 122 (1) May increase costs to the sponsor or its covered 123 persons as compared to a more pr udent action that could be 124 taken; or 125 (2) Present a conflict of interest between the 126 interests of the sponsor and its covered persons and the 127 interests of the pharmacy benefits manager. 128 11. Any entity that enters into a contract to sell, 129 provide, pay, or reimburse a pharmacy in the state for 130 prescription drugs on behalf of itself or another entity 131 shall not prohibit a health benefit plan sponsor and a 132 participating pharmacy from discussing any health benefit 133 plan information, including ph armacy claims data or costs. 134 12. It shall be unlawful for any pharmacy benefits 135 manager or any person acting on its behalf to charge a 136 health benefit plan or payer a different amount for a 137 prescription drug's ingredient cost or dispensing fee than 138 the amount the pharmacy benefits manager reimburses a 139 pharmacy for the prescription drug's ingredient cost or 140 dispensing fee if the pharmacy benefits manager retains any 141 amount of any such difference. 142 13. The department of commerce and insurance shall 143 enforce this section. 144 376.388. 1. As used in this section, unless the 1 context requires otherwise, the following terms shall mean: 2 (1) "Contracted pharmacy" [or "pharmacy"], a pharmacy 3 located in Missouri participating i n the network of a 4 pharmacy benefits manager through a direct or indirect 5 contract; 6 (2) ["Health carrier", an entity subject to the 7 insurance laws and regulations of this state that contracts 8 SB 512 7 or offers to contract to provide, deliver, arrange for , pay 9 for, or reimburse any of the costs of health care services, 10 including a sickness and accident insurance company, a 11 health maintenance organization, a nonprofit hospital and 12 health service corporation, or any other entity providing a 13 plan of health insurance, health benefits, or health 14 services, except that such plan shall not include any 15 coverage pursuant to a liability insurance policy, workers' 16 compensation insurance policy, or medical payments insurance 17 issued as a supplement to a liabilit y policy; 18 (3)] "Maximum allowable cost", the per -unit amount 19 that a pharmacy benefits manager reimburses a pharmacist for 20 a prescription drug, excluding a dispensing or professional 21 fee; 22 [(4)] (3) "Maximum allowable cost list" or "MAC list", 23 a listing of drug products that meet the standard described 24 in this section; 25 [(5)] (4) "Pharmacy", as such term is defined in 26 chapter 338; 27 [(6)] (5) "Pharmacy benefits manager", an entity that 28 contracts with pharmacies on behalf of health carriers [or 29 any health plan sponsored by the state or a political 30 subdivision of the state ] or health benefit plans to provide 31 prescription drug and pharmacist services; 32 (6) "Pharmacy benefits manager affiliate", a pharmacy 33 or pharmacist that di rectly or indirectly, through one or 34 more intermediaries, owns or controls, is owned or 35 controlled by, or is under common ownership or control with 36 a pharmacy benefits manager . 37 2. Upon each contract execution or renewal between a 38 pharmacy benefits manager and a pharmacy or between a 39 pharmacy benefits manager and a pharmacy's contracting 40 SB 512 8 representative or agent, such as a pharmacy services 41 administrative organization, a pharmacy benefits manager 42 shall, with respect to such contract or renewal: 43 (1) Include in such contract or renewal the sources 44 utilized to determine maximum allowable cost and update such 45 pricing information at least every seven days; and 46 (2) Maintain a procedure to eliminate products from 47 the maximum allowable cos t list of drugs subject to such 48 pricing or modify maximum allowable cost pricing at least 49 every seven days, if such drugs do not meet the standards 50 and requirements of this section, in order to remain 51 consistent with pricing changes in the marketplace. 52 3. A pharmacy benefits manager shall reimburse 53 pharmacies for drugs subject to maximum allowable cost 54 pricing that has been updated to reflect market pricing at 55 least every seven days as set forth under subdivision (1) of 56 subsection 2 of this se ction. 57 4. A pharmacy benefits manager shall not place a drug 58 on a maximum allowable cost list unless there are at least 59 two therapeutically equivalent multisource generic drugs, or 60 at least one generic drug available from at least one 61 manufacturer, generally available for purchase by network 62 pharmacies from national or regional wholesalers. 63 5. (1) All contracts between a pharmacy benefits 64 manager and a contracted pharmacy or between a pharmacy 65 benefits manager and a pharmacy's contractin g representative 66 or agent, such as a pharmacy services administrative 67 organization, shall include a process to internally appeal, 68 investigate, and resolve disputes regarding maximum 69 allowable cost pricing. The process shall include the 70 following: 71 SB 512 9 [(1)] (a) The right to appeal shall be limited to 72 fourteen calendar days following the reimbursement of the 73 initial claim; and 74 [(2)] (b) A requirement that the pharmacy benefits 75 manager shall respond to an appeal described in this 76 subsection no later than fourteen calendar days after the 77 date the appeal was received by such pharmacy benefits 78 manager. 79 (2) If a reimbursement to a contracted pharmacy is 80 below the pharmacy's cost to purchase the drug, the pharmacy 81 may decline to dispense the prescription. A pharmacy 82 benefits manager shall not prohibit a pharmacy from 83 declining to dispense a drug for such reason or otherwise 84 retaliate against a pharmacy for doing so. 85 (3) A pharmacy benefits manager shall not: 86 (a) Pay or reimburse a pharmacy or pharmacist in the 87 state an amount less than the amount that the pharmacy 88 benefits manager reimburses a pharmacy benefits manager 89 affiliate for providing the same products and pharmacist 90 services, which amount shall be calculated on a per-unit 91 basis using the same generic product identifier or generic 92 code number; 93 (b) Pay or reimburse a pharmacy or pharmacist in the 94 state for the ingredient drug product component of 95 pharmacist services less than the national average drug 96 acquisition cost or, if the national average drug 97 acquisition cost is unavailable, the wholesale acquisition 98 cost; 99 (c) Make or permit any reduction of payment for 100 pharmacist services by a pharmacy benefits manager or a 101 health care payer directly or indirectly to a pharmacy under 102 a reconciliation process to an effective rate of 103 SB 512 10 reimbursement including, but not limited to, generic 104 effective rates, brand effective rates, direct and indirect 105 remuneration fees, or any other reduction or aggregate 106 reduction of payment; or 107 (d) Remove from any pharmacy its legal right to civil 108 recourse including, but not limited to, requiring a pharmacy 109 to use arbitration to settle grievances. 110 6. For appeals that are denied, the pharmacy benefits 111 manager shall provide the reason for the denial and identify 112 the national drug code of a drug product that may be 113 purchased by contracted pharmacies at a price at or below 114 the maximum allowable cost and, when applicable, may be 115 substituted lawfully. 116 7. If the appeal is successful, the pharmacy benefits 117 manager shall: 118 (1) Adjust the maximum allowable cost price that is 119 the subject of the appeal effective on the day after the 120 date the appeal is decided; 121 (2) Apply the adjusted maximum allowabl e cost price to 122 all similarly situated pharmacies as determined by the 123 pharmacy benefits manager; and 124 (3) Allow the pharmacy that succeeded in the appeal to 125 reverse and rebill the pharmacy benefits claim giving rise 126 to the appeal. 127 8. Appeals shall be upheld if: 128 (1) The pharmacy being reimbursed for the drug subject 129 to the maximum allowable cost pricing in question was not 130 reimbursed as required under subsection 3 of this section; or 131 (2) The drug subject to the maximum allowable cost 132 pricing in question does not meet the requirements set forth 133 under subsection 4 of this section. 134 SB 512 11 376.448. 1. As used in this section, the following 1 terms mean: 2 (1) "Cost-sharing", any co-payment, coinsurance, 3 deductible, amount paid by an enrollee for health care 4 services in excess of a coverage limitation, or similar 5 charge required by or on behalf of an enrollee in order to 6 receive a specific health care service covered by a health 7 benefit plan, whether covered und er medical benefits or 8 pharmacy benefits. The term "cost-sharing" shall include 9 cost-sharing as defined in 42 U.S.C. Section 18022(c); 10 (2) "Enrollee", the same meaning given to the term in 11 section 376.1350; 12 (3) "Health benefit plan", the sa me meaning given to 13 the term in section 376.1350; 14 (4) "Health care service", the same meaning given to 15 the term in section 376.1350; 16 (5) "Health carrier", the same meaning given to the 17 term in section 376.1350; 18 (6) "Pharmacy benefits m anager", the same meaning 19 given to the term in section 376.388. 20 2. When calculating an enrollee's overall contribution 21 to any out-of-pocket maximum or any cost -sharing requirement 22 under a health benefit plan, a health carrier or pharmacy 23 benefits manager shall include any amounts paid by the 24 enrollee or paid on behalf of the enrollee for any 25 medication where a generic substitute for such medication is 26 not available. 27 3. A health carrier or pharmacy benefits manager shall 28 not vary an enrollee's out-of-pocket maximum or any cost - 29 sharing requirement based on, or otherwise design benefits 30 in a manner that takes into account, the availability of any 31 SB 512 12 cost-sharing assistance program for any medication where a 32 generic substitute for such medic ation is not available. 33 4. If, under federal law, application of the 34 requirement under subsection 2 of this section would result 35 in health savings account ineligibility under Section 223 of 36 the Internal Revenue Code of 1986, as amended, the 37 requirement under subsection 2 of this section shall apply 38 to health savings account -qualified high deductible health 39 plans with respect to any cost -sharing of such a plan after 40 the enrollee has satisfied the minimum deductible under 41 Section 223, except wit h respect to items or services that 42 are preventive care under Section 223(c)(2)(C) of the 43 Internal Revenue Code of 1986, as amended, in which case the 44 requirement of subsection 2 of this section shall apply 45 regardless of whether the minimum deductible under Section 46 223 has been satisfied. 47 5. Nothing in this section shall prohibit a health 48 carrier or health benefit plan from utilizing step therapy 49 in accordance with section 376.2034. 50 6. The provisions of this section shall not apply to 51 health benefit plans that are covered under the Labor 52 Management Relations Act of 1947, 29 U.S.C. Section 141, et 53 seq., as amended. 54