21 | 15 | | |
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22 | 16 | | AN ACT concerning 1 |
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23 | 17 | | |
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24 | 18 | | Health Insurance – Coverage for Specialty Drugs 2 |
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25 | 19 | | |
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26 | 20 | | FOR the purpose of prohibiting certain insurers, nonprofit health service plans, and health 3 |
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27 | 21 | | maintenance organizations from excluding coverage for certain specialty drugs that 4 |
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28 | 22 | | are administered or dispensed by a provider that meets certain criteria; requiring 5 |
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29 | 23 | | the reimbursement rate for certain specialty drugs to meet certain criteria; and 6 |
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30 | 24 | | generally relating to health insurance coverage for specialty drugs. 7 |
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31 | 25 | | |
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32 | 26 | | BY repealing and reenacting, without amendments, 8 |
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33 | 27 | | Article – Insurance 9 |
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34 | 28 | | Section 15–847(a)(1) and (5) 10 |
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35 | 29 | | Annotated Code of Maryland 11 |
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36 | 30 | | (2017 Replacement Volume and 2024 Supplement) 12 |
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37 | 31 | | |
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38 | 32 | | BY repealing and reenacting, with amendments, 13 |
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39 | 33 | | Article – Insurance 14 |
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40 | 34 | | Section 15–847(d), 15–1611.1, and 15–1612 15 |
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41 | 35 | | Annotated Code of Maryland 16 |
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42 | 36 | | (2017 Replacement Volume and 2024 Supplement) 17 |
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43 | 37 | | |
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44 | 38 | | BY adding to 18 |
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45 | 39 | | Article – Insurance 19 |
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48 | | - | (2017 Replacement Volume and 2024 Supplement) 22 2 SENATE BILL 975 |
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| 42 | + | (2017 Replacement Volume and 2024 Supplement) 22 |
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| 43 | + | |
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| 44 | + | SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF M ARYLAND, 23 |
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| 45 | + | That the Laws of Maryland read as follows: 24 |
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| 46 | + | |
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| 47 | + | Article – Insurance 25 |
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| 48 | + | 2 SENATE BILL 975 |
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| 49 | + | |
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| 50 | + | |
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| 51 | + | 15–847. 1 |
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| 52 | + | |
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| 53 | + | (a) (1) In this section the following words have the meanings indicated. 2 |
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| 54 | + | |
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| 55 | + | (5) (i) “Specialty drug” means a prescription drug that: 3 |
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| 56 | + | |
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| 57 | + | 1. is prescribed for an individual with a complex or chronic 4 |
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| 58 | + | medical condition or a rare medical condition; 5 |
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| 59 | + | |
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| 60 | + | 2. costs $600 or more for up to a 30–day supply; 6 |
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| 61 | + | |
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| 62 | + | 3. is not typically stocked at retail pharmacies; and 7 |
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| 63 | + | |
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| 64 | + | 4. A. requires a difficult or unusual process of delivery to 8 |
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| 65 | + | the patient in the preparation, handling, storage, inventory, or distribution of the drug; or 9 |
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| 66 | + | |
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| 67 | + | B. requires enhanced patient education, management, or 10 |
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| 68 | + | support, beyond those required for traditional dispensing, before or after administration of 11 |
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| 69 | + | the drug. 12 |
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| 70 | + | |
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| 71 | + | (ii) “Specialty drug” does not include a prescription drug prescribed 13 |
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| 72 | + | to treat diabetes, HIV, or AIDS. 14 |
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| 73 | + | |
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| 74 | + | (d) Subject to § 15–805 of this subtitle [and], notwithstanding § 15–806 of this 15 |
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| 75 | + | subtitle, [nothing in] AND EXCEPT AS PROVID ED IN § 15–847.2 OF THIS SUBTITLE, this 16 |
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| 76 | + | article or regulations adopted under this article [precludes] DO NOT PRECLUDE an entity 17 |
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| 77 | + | subject to this section from requiring a covered specialty drug to be obtained through: 18 |
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| 78 | + | |
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| 79 | + | (1) a designated pharmacy or other source authorized under the Health 19 |
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| 80 | + | Occupations Article to dispense or administer prescription drugs; or 20 |
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| 81 | + | |
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| 82 | + | (2) a pharmacy participating in the entity’s provider network, if the entity 21 |
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| 83 | + | determines that the pharmacy: 22 |
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| 84 | + | |
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| 85 | + | (i) meets the entity’s performance standards; and 23 |
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| 86 | + | |
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| 87 | + | (ii) accepts the entity’s network reimbursement rates. 24 |
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| 88 | + | |
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| 89 | + | 15–847.2. 25 |
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| 90 | + | |
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| 91 | + | (A) IN THIS SECTION, “SPECIALTY DRUG ” HAS THE MEANING STAT ED IN § 26 |
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| 92 | + | 15–847 OF THIS SUBTITLE . 27 |
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| 93 | + | |
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| 94 | + | (B) (1) THIS SECTION APPLIES TO: 28 |
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| 95 | + | SENATE BILL 975 3 |
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| 96 | + | |
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| 97 | + | |
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| 98 | + | (I) INSURERS AND NONPROF IT HEALTH SERVICE PL ANS THAT 1 |
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| 99 | + | PROVIDE COVERAGE FOR PRESCRIPTION DRU GS UNDER INDIVIDUAL , GROUP, OR 2 |
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| 100 | + | BLANKET HEALTH INSUR ANCE POLICIES OR CON TRACTS THAT ARE ISSU ED OR 3 |
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| 101 | + | DELIVERED IN THE STATE; AND 4 |
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| 102 | + | |
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| 103 | + | (II) HEALTH MAINTENANCE O RGANIZATIONS THAT PR OVIDE 5 |
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| 104 | + | COVERAGE FOR PRESCRI PTION DRUGS UNDER IN DIVIDUAL OR GROUP CONTRACTS 6 |
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| 105 | + | THAT ARE ISSUED OR D ELIVERED IN THE STATE. 7 |
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| 106 | + | |
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| 107 | + | (2) AN INSURER, A NONPROFIT HEALTH S ERVICE PLAN, OR A HEALTH 8 |
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| 108 | + | MAINTENANCE ORGANIZA TION THAT PROVIDES C OVERAGE FOR PRESCRIP TION 9 |
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| 109 | + | DRUGS THROUGH A PHAR MACY BENEFITS MANAGE R IS SUBJECT TO THE 10 |
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| 110 | + | REQUIREMENT S OF THIS SECTION. 11 |
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| 111 | + | |
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| 112 | + | (C) AN ENTITY SUBJECT TO THIS SECTION MAY NOT EXCLUDE COVERAGE 12 |
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| 113 | + | FOR A COVERED SPECIA LTY DRUG ADMINISTERE D OR DISPENSED BY A PROVIDER 13 |
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| 114 | + | UNDER § 12–102 OF THE HEALTH OCCUPATIONS ARTICLE IF THE ENTITY 14 |
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| 115 | + | DETERMINES THAT: 15 |
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| 116 | + | |
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| 117 | + | (1) THE PROVIDER THAT ADMINISTERS OR DISPENSES THE COVERE D 16 |
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| 118 | + | SPECIALTY DRUG : 17 |
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| 119 | + | |
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| 120 | + | (I) IS AN IN–NETWORK PROVIDER OF COVERED MEDICAL 18 |
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| 121 | + | ONCOLOGY SERVICES ; AND 19 |
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| 122 | + | |
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| 123 | + | (II) COMPLIES WITH STATE REGULATIONS FOR THE 20 |
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| 124 | + | ADMINISTERING AND DISPENSING OF SPECIA LTY DRUGS; AND 21 |
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| 125 | + | |
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| 126 | + | (2) THE COVERED SPECIALTY DRUG IS : 22 |
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| 127 | + | |
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| 128 | + | (I) INFUSED, AUTO–INJECTED, OR AN ORAL TARGETED 23 |
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| 129 | + | IMMUNE MODULATOR ; OR 24 |
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| 130 | + | |
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| 131 | + | (II) AN ORAL MEDICATION T HAT: 25 |
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| 132 | + | |
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| 133 | + | 1. REQUIRES COMPLEX DOS ING BASED ON CLINICA L 26 |
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| 134 | + | PRESENTATION ; OR 27 |
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| 135 | + | |
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| 136 | + | 2. IS USED CONCOMITANTL Y WITH OTHER INFUSIO N OR 28 |
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| 137 | + | RADIATION THERAPIES. 29 |
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| 138 | + | |
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| 139 | + | (D) THE REIMBURSEMENT RAT E FOR SPECIALTY DRUG S COVERED UNDER 30 |
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| 140 | + | THIS SECTION SHALL B E: 31 4 SENATE BILL 975 |
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92 | | - | (i) meets the entity’s performance standards; and 27 |
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93 | | - | |
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94 | | - | (ii) accepts the entity’s network reimbursement rates. 28 |
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95 | | - | SENATE BILL 975 3 |
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96 | | - | |
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97 | | - | |
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98 | | - | (H) THIS SECTION MAY NOT BE CONSTRUED TO SUPE RSEDE THE AUTHORITY 1 |
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99 | | - | OF THE HEALTH SERVICES COST REVIEW COMMISSION TO SET RAT ES FOR 2 |
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100 | | - | SPECIALTY DRUGS ADMI NISTERED TO PATIENTS IN A SETTING REGULAT ED BY THE 3 |
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101 | | - | HEALTH SERVICES COST REVIEW COMMISSION. 4 |
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102 | | - | |
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103 | | - | 15–847.2. 5 |
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104 | | - | |
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105 | | - | (A) IN THIS SECTION, “SPECIALTY DRUG ” HAS THE MEAN ING STATED IN § 6 |
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106 | | - | 15–847 OF THIS SUBTITLE . 7 |
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107 | | - | |
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108 | | - | (B) (1) THIS SECTION APPLIES TO: 8 |
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109 | | - | |
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110 | | - | (I) INSURERS AND NONPROF IT HEALTH SERVICE PL ANS THAT 9 |
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111 | | - | PROVIDE COVERAGE FOR PRESCRIPTION DRUGS U NDER INDIVIDUAL , GROUP, OR 10 |
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112 | | - | BLANKET HEALTH INSUR ANCE POLICIES OR CON TRACTS THAT ARE ISSUED OR 11 |
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113 | | - | DELIVERED IN THE STATE; AND 12 |
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114 | | - | |
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115 | | - | (II) HEALTH MAINTENANCE O RGANIZATIONS THAT PR OVIDE 13 |
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116 | | - | COVERAGE FOR PRESCRI PTION DRUGS UNDER IN DIVIDUAL OR GROUP CO NTRACTS 14 |
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117 | | - | THAT ARE ISSUED OR D ELIVERED IN THE STATE. 15 |
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118 | | - | |
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119 | | - | (2) AN INSURER, A NONPROFIT HEALTH S ERVICE PLAN, OR A HEALTH 16 |
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120 | | - | MAINTENANCE ORGANIZA TION THAT PROVIDES C OVERAGE FOR PRESCRIP TION 17 |
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121 | | - | DRUGS THROUGH A PHAR MACY BENEFITS MANAGE R IS SUBJECT TO THE 18 |
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122 | | - | REQUIREMENTS OF THIS SECTION. 19 |
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123 | | - | |
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124 | | - | (C) AN ENTITY SUBJECT TO THIS SECTION MAY NOT EXCLUDE COVERAGE 20 |
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125 | | - | FOR A COVERED SPECIA LTY DRUG ADMINISTERED OR DISPENSED BY A PROVI DER 21 |
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126 | | - | UNDER § 12–102 OF THE HEALTH OCCUPATIONS ARTICLE IF THE ENTITY 22 |
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127 | | - | DETERMINES THAT : 23 |
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128 | | - | |
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129 | | - | (1) THE PROVIDER THAT AD MINISTERS OR DISPENS ES THE COVERED 24 |
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130 | | - | SPECIALTY DRUG : 25 |
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131 | | - | |
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132 | | - | (I) IS AN IN–NETWORK PROVIDER OF COVERED MEDICAL 26 |
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133 | | - | ONCOLOGY SERVICES ; AND 27 |
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134 | | - | |
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135 | | - | (II) COMPLIES WITH STATE REGULATIONS FOR THE 28 |
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136 | | - | ADMINISTERING AND DI SPENSING OF SPECIALT Y DRUGS; AND 29 |
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137 | | - | |
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138 | | - | (2) THE COVERED SPECIALT Y DRUG IS: 30 |
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139 | | - | |
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140 | | - | (I) INFUSED, AUTO–INJECTED, OR AN ORAL TARGETED 31 |
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141 | | - | IMMUNE MODULATOR ; OR 32 4 SENATE BILL 975 |
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| 187 | + | (3) to a chain pharmacy with more than 15 stores or a pharmacist who is 30 |
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| 188 | + | an employee of the chain pharmacy. 31 SENATE BILL 975 5 |
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150 | | - | 2. IS USED CONCOMITANTL Y WITH OTHER INFUSIO N OR 4 |
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151 | | - | RADIATION THERAPIES . 5 |
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152 | | - | |
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153 | | - | (D) (1) THE SUBJECT TO SUBSECTION (F) OF THIS SECTION , THE 6 |
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154 | | - | REIMBURSEMENT RATE F OR SPECIALTY DRUGS COVERED UNDER THIS S ECTION 7 |
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155 | | - | SHALL BE: 8 |
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156 | | - | |
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157 | | - | (1) (I) AGREED TO BY THE COV ERED, IN–NETWORK PROVIDER AND 9 |
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158 | | - | THE ENTITY SUBJECT T O THIS SECTION; AND 10 |
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159 | | - | |
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160 | | - | (2) (II) BILLED AT A NONHOSPI TAL LEVEL OF CARE OR PLACE OF 11 |
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161 | | - | SERVICE. 12 |
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162 | | - | |
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163 | | - | (2) UNLESS OTHERWISE AGRE ED TO BY THE COVERED, IN–NETWORK 13 |
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164 | | - | PROVIDER AND THE ENT ITY SUBJECT TO THIS SECTION, THE REIMBURSEMENT RA TE 14 |
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165 | | - | FOR SPECIALTY DRUGS COVERED UNDER THIS S ECTION MAY NOT EXCEE D THE RATE 15 |
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166 | | - | APPLICABLE TO A DESI GNATED SPECIALTY PHA RMACY FOR DISPENSING THE 16 |
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167 | | - | COVERED SPECIALTY DR UGS. 17 |
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168 | | - | |
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169 | | - | (E) THIS SECTION DOES NOT PROHIBIT AN ENTITY S UBJECT TO THIS 18 |
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170 | | - | SECTION FROM REFUSIN G TO AUTHORIZE OR AP PROVE OR FROM DENYIN G 19 |
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171 | | - | COVERAGE FOR A COVER ED SPECIALTY DRUG AD MINISTERED OR DISPEN SED BY A 20 |
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172 | | - | PROVIDER IF ADMINIST ERING OR DISPENSING THE DRUG FAILS TO SA TISFY 21 |
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173 | | - | MEDICAL NECESSITY CR ITERIA. 22 |
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174 | | - | |
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175 | | - | (F) THIS SECTION MAY NOT BE CONSTRUED TO SUPE RSEDE THE AUTHORITY 23 |
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176 | | - | OF THE HEALTH SERVICES COST REVIEW COMMISSION TO SET RAT ES FOR 24 |
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177 | | - | SPECIALTY DRUGS ADMI NISTERED TO PATIENTS IN A SETTING REGULAT ED BY THE 25 |
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178 | | - | HEALTH SERVICES COST REVIEW COMMISSION. 26 |
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179 | | - | |
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180 | | - | 15–1611.1. 27 |
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181 | | - | |
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182 | | - | (a) This section applies only to a pharmacy benefits manager that provides 28 |
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183 | | - | pharmacy benefits management services on behalf of a carrier. 29 |
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184 | | - | |
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185 | | - | (b) Except as provided in subsection (c) of this section, a pharmacy benefits 30 |
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186 | | - | manager may not require that a beneficiary use a specific pharmacy or entity to fill a 31 |
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187 | | - | prescription if: 32 |
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188 | | - | SENATE BILL 975 5 |
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189 | | - | |
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190 | | - | |
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191 | | - | (1) the pharmacy benefits manager or a corporate affiliate of the pharmacy 1 |
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192 | | - | benefits manager has an ownership interest in the pharmacy or entity; or 2 |
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193 | | - | |
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194 | | - | (2) the pharmacy or entity has an ownership interest in the pharmacy 3 |
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195 | | - | benefits manager or a corporate affiliate of the pharmacy benefits manager. 4 |
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196 | | - | |
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197 | | - | (c) [A] EXCEPT AS PROVIDED IN § 15–847.2 OF THIS TITLE, A pharmacy 5 |
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198 | | - | benefits manager may require a beneficiary to use a specific pharmacy or entity for a 6 |
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199 | | - | specialty drug as defined in § 15–847 of this title. 7 |
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200 | | - | |
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201 | | - | 15–1612. 8 |
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202 | | - | |
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203 | | - | (a) This section applies only to a pharmacy benefits manager that provides 9 |
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204 | | - | pharmacy benefits management services on behalf of a carrier. 10 |
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205 | | - | |
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206 | | - | (b) This section does not apply to reimbursement: 11 |
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207 | | - | |
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208 | | - | (1) EXCEPT AS PROVIDED I N § 15–847.2 OF THIS TITLE, for specialty 12 |
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209 | | - | drugs; 13 |
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210 | | - | |
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211 | | - | (2) for mail order drugs; or 14 |
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212 | | - | |
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213 | | - | (3) to a chain pharmacy with more than 15 stores or a pharmacist who is 15 |
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214 | | - | an employee of the chain pharmacy. 16 |
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215 | | - | |
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216 | | - | (c) A pharmacy benefits manager may not reimburse a pharmacy or pharmacist 17 |
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217 | | - | for a pharmaceutical product or pharmacist service in an amount less than the amount that 18 |
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218 | | - | the pharmacy benefits manager reimburses itself or an affiliate for providing the same 19 |
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219 | | - | product or service. 20 |
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220 | | - | |
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221 | | - | SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 21 |
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222 | | - | policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 22 |
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223 | | - | after January 1, 2026. 23 |
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224 | | - | |
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225 | | - | SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect 24 |
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226 | | - | January 1, 2026. 25 |
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227 | | - | |
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| 201 | + | SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect 8 |
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| 202 | + | January 1, 2026. 9 |
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