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2 | 2 | | HOUSE DOCKET, NO. 2503 FILED ON: 1/19/2023 |
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3 | 3 | | HOUSE . . . . . . . . . . . . . . . No. 945 |
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4 | 4 | | The Commonwealth of Massachusetts |
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5 | 5 | | _________________ |
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6 | 6 | | PRESENTED BY: |
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7 | 7 | | Christine P. Barber and Jon Santiago |
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8 | 8 | | _________________ |
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9 | 9 | | To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General |
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10 | 10 | | Court assembled: |
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11 | 11 | | The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill: |
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12 | 12 | | An Act to ensure prescription drug cost transparency and affordability. |
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13 | 13 | | _______________ |
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14 | 14 | | PETITION OF: |
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15 | 15 | | NAME:DISTRICT/ADDRESS :DATE ADDED:Christine P. Barber34th Middlesex1/19/2023Jon Santiago9th Suffolk1/19/2023Lindsay N. Sabadosa1st Hampshire1/19/2023Mindy Domb3rd Hampshire1/19/2023Carmine Lawrence Gentile13th Middlesex1/25/2023David Paul Linsky5th Middlesex1/26/2023Lenny Mirra2nd Essex1/26/2023Peter Capano11th Essex1/27/2023Susannah M. Whipps2nd Franklin1/27/2023Brian W. Murray10th Worcester1/29/2023Jack Patrick Lewis7th Middlesex2/1/2023Vanna Howard17th Middlesex2/1/2023Patricia A. Duffy5th Hampden2/2/2023Kevin G. Honan17th Suffolk2/3/2023Jennifer Balinsky Armini8th Essex2/4/2023David Henry Argosky LeBoeuf17th Worcester2/6/2023Jason M. LewisFifth Middlesex2/7/2023Patrick M. O'ConnorFirst Plymouth and Norfolk2/8/2023 2 of 2 |
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16 | 16 | | Colleen M. Garry36th Middlesex2/13/2023James C. Arena-DeRosa8th Middlesex2/13/2023James B. EldridgeMiddlesex and Worcester2/16/2023Kate Lipper-Garabedian32nd Middlesex2/22/2023Natalie M. Higgins4th Worcester2/23/2023Tram T. Nguyen18th Essex2/27/2023 1 of 29 |
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17 | 17 | | HOUSE DOCKET, NO. 2503 FILED ON: 1/19/2023 |
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18 | 18 | | HOUSE . . . . . . . . . . . . . . . No. 945 |
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19 | 19 | | By Representatives Barber of Somerville and Santiago of Boston, a petition (accompanied by |
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20 | 20 | | bill, House, No. 945) of Christine P. Barber, Jon Santiago and others for legislation to ensure |
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21 | 21 | | prescription drug cost transparency and affordability. Financial Services. |
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22 | 22 | | The Commonwealth of Massachusetts |
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23 | 23 | | _______________ |
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24 | 24 | | In the One Hundred and Ninety-Third General Court |
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25 | 25 | | (2023-2024) |
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26 | 26 | | _______________ |
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27 | 27 | | An Act to ensure prescription drug cost transparency and affordability. |
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28 | 28 | | Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority |
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29 | 29 | | of the same, as follows: |
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30 | 30 | | 1 SECTION 1. Section 1 of chapter 6D of the General Laws, as appearing so appearing, is |
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31 | 31 | | 2hereby amended by inserting after the definition of “Alternative payment methodologies or |
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32 | 32 | | 3methods” the following 2 definitions:- |
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33 | 33 | | 4 “Biosimilar”, a drug that is produced or distributed pursuant to a biologics license |
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34 | 34 | | 5application approved under 42 U.S.C. 262(k)(3). |
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35 | 35 | | 6 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new |
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36 | 36 | | 7drug application approved under 21 U.S.C. 355(c) except for an authorized generic as defined by |
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37 | 37 | | 842 C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application |
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38 | 38 | | 9approved under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand |
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39 | 39 | | 10name drug based on available data resources such as Medi-Span. |
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40 | 40 | | 11 SECTION 2. Said section 1 of said chapter 6D, as so appearing, is hereby further |
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41 | 41 | | 12amended by inserting after the definition of “Fiscal year” the following definition:- 2 of 29 |
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42 | 42 | | 13 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an |
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43 | 43 | | 14abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic as |
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44 | 44 | | 15defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962 and |
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45 | 45 | | 16was not originally marketed under a new drug application; or (iv) identified by the health benefit |
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46 | 46 | | 17plan as a generic drug based on available data resources such as Medi-Span. |
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47 | 47 | | 18 SECTION 3. Said section 1 of said chapter 6D, as so appearing, is hereby further |
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48 | 48 | | 19amended by striking out, in line 189, the words “not include excludes ERISA plans” and |
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49 | 49 | | 20inserting in place thereof the following words:- include self-insured plans to the extent allowed |
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50 | 50 | | 21under the federal Employee Retirement Income Security Act of 1974. |
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51 | 51 | | 22 SECTION 4. Said section 1 of said chapter 6D, as so appearing, is hereby further |
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52 | 52 | | 23amended by inserting after the definition of “Performance penalty” the following 2 definitions:- |
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53 | 53 | | 24 “Pharmaceutical manufacturing company”, an entity engaged in the: (i) production, |
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54 | 54 | | 25preparation, propagation, compounding, conversion or processing of prescription drugs, directly |
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55 | 55 | | 26or indirectly, by extraction from substances of natural origin, independently by means of |
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56 | 56 | | 27chemical synthesis or by a combination of extraction and chemical synthesis; or (ii) packaging, |
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57 | 57 | | 28repackaging, labeling, relabeling or distribution of prescription drugs; provided, however, that |
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58 | 58 | | 29“pharmaceutical manufacturing company” shall not include a wholesale drug distributor licensed |
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59 | 59 | | 30under section 36B of chapter 112 or a retail pharmacist registered under section 39 of said |
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60 | 60 | | 31chapter 112. |
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61 | 61 | | 32 “Pharmacy benefit manager”, a person, business or other entity, however organized, that |
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62 | 62 | | 33directly or through a subsidiary provides pharmacy benefit management services for prescription |
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63 | 63 | | 34drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self- 3 of 29 |
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64 | 64 | | 35insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit |
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65 | 65 | | 36management services shall include, but not be limited to, the processing and payment of claims |
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66 | 66 | | 37for prescription drugs, the performance of drug utilization review, the processing of drug prior |
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67 | 67 | | 38authorization requests, pharmacy contracting, the adjudication of appeals or grievances related to |
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68 | 68 | | 39prescription drug coverage contracts, formulary administration, drug benefit design, mail and |
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69 | 69 | | 40specialty drug pharmacy services, cost containment, clinical, safety and adherence programs for |
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70 | 70 | | 41pharmacy services and managing the cost of covered prescription drugs; provided further, that |
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71 | 71 | | 42“pharmacy benefit manager” shall include a health benefit plan that does not contract with a |
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72 | 72 | | 43pharmacy benefit manager and manages its own prescription drug benefits unless specifically |
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73 | 73 | | 44exempted by the commission. |
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74 | 74 | | 45 SECTION 5. Said section 1 of said chapter 6D, as so appearing, is hereby further |
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75 | 75 | | 46amended by adding the following definition:- |
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76 | 76 | | 47 “Wholesale acquisition cost”, shall have the same meaning as defined in 42 U.S.C. |
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77 | 77 | | 481395w-3a(c)(6)(B). |
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78 | 78 | | 49 SECTION 6. Said chapter 6D is hereby further amended by striking out section 2A, as so |
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79 | 79 | | 50appearing, and inserting in place thereof the following section:- |
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80 | 80 | | 51 Section 2A. The commission shall keep confidential all nonpublic clinical, financial, |
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81 | 81 | | 52strategic or operational documents or information provided or reported to the commission in |
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82 | 82 | | 53connection with any care delivery, quality improvement process, performance improvement plan |
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83 | 83 | | 54authorized under sections 7, 10, 14, 15 or 20 of this chapter or under section 2GGGG of chapter |
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84 | 84 | | 5529 and shall not disclose the information or documents to any person without the consent of the |
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85 | 85 | | 56payer, provider or pharmaceutical manufacturing company providing or reporting the 4 of 29 |
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86 | 86 | | 57information or documents under said sections 7, 10, 14, 15, or 20 of this chapter or under said |
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87 | 87 | | 58section 2GGGG of said chapter 29, except in summary form in evaluative reports of such |
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88 | 88 | | 59activities or when the commission believes that such disclosure should be made in the public |
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89 | 89 | | 60interest after taking into account any privacy, trade secret or anticompetitive considerations. The |
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90 | 90 | | 61confidential information and documents shall not be public records and shall be exempt from |
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91 | 91 | | 62disclosure under clause Twenty sixth of section 7 of chapter 4 or section 10 of chapter 66. |
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92 | 92 | | 63 SECTION 7. Section 6 of said chapter 6D, as so appearing, is hereby amended by |
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93 | 93 | | 64inserting after the word “center”, in line 1, the following words:- , pharmaceutical and |
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94 | 94 | | 65biopharmaceutical manufacturing company, pharmacy benefit manager. |
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95 | 95 | | 66 SECTION 8. Said section 6 of said chapter 6D, as so appearing, is hereby further |
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96 | 96 | | 67amended by striking out, in lines 5 and 36, the figure “33” and inserting in place thereof, in each |
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97 | 97 | | 68instance, the following figure:- 25. |
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98 | 98 | | 69 SECTION 9. Said section 6 of said chapter 6D, as so appearing, is hereby further |
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99 | 99 | | 70amended by adding the following paragraph:- |
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100 | 100 | | 71 The assessed amount for pharmaceutical and biopharmaceutical manufacturing |
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101 | 101 | | 72companies and pharmacy benefit managers shall be not less than 25 per cent of the amount |
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102 | 102 | | 73appropriated by the general court for the expenses of the commission minus amounts collected |
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103 | 103 | | 74from: (i) filing fees; (ii) fees and charges generated by the commission's publication or |
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104 | 104 | | 75dissemination of reports and information; and (iii) federal matching revenues received for these |
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105 | 105 | | 76expenses or received retroactively for expenses of predecessor agencies. Pharmaceutical and |
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106 | 106 | | 77biopharmaceutical manufacturing companies and pharmacy benefit managers shall, in a manner |
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107 | 107 | | 78and distribution determined by the commission, pay to the commonwealth an amount of the 5 of 29 |
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108 | 108 | | 79estimated expenses of the commission attributable to the commission’s activities under sections |
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109 | 109 | | 808, 9 and 20. A pharmacy benefit manager that is a surcharge payor subject to the preceding |
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110 | 110 | | 81paragraph and manages its own prescription drug benefits shall not be subject to additional |
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111 | 111 | | 82assessment under this paragraph. |
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112 | 112 | | 83 SECTION 10. Section 8 of said chapter 6D, as so appearing, is hereby amended by |
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113 | 113 | | 84inserting after the word “organization”, in lines 6 and 7, the following words:- , pharmacy benefit |
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114 | 114 | | 85manager, pharmaceutical manufacturing company. |
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115 | 115 | | 86 SECTION 11. Said section 8 of said chapter 6D, as so appearing, is hereby further |
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116 | 116 | | 87amended by inserting after the word “organizations”, in line 14, the following words:- , |
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117 | 117 | | 88pharmacy benefit managers, pharmaceutical manufacturing companies. |
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118 | 118 | | 89 SECTION 12. Said section 8 of said chapter 6D, as so appearing, is hereby further |
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119 | 119 | | 90amended by striking out, in line 32, the words “and (xi)” and inserting in place thereof the |
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120 | 120 | | 91following words:- (xi) at least 3 representatives of the pharmaceutical industry; (xii) at least 1 |
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121 | 121 | | 92pharmacy benefit manager; and (xiii). |
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122 | 122 | | 93 SECTION 13. Said section 8 of said chapter 6D, as so appearing, is hereby further |
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123 | 123 | | 94amended by inserting after the word “commission”, in line 59, the first time it appears, the |
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124 | 124 | | 95following words:- ; and (iii) in the case of pharmacy benefit managers and pharmaceutical |
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125 | 125 | | 96manufacturing companies, testimony concerning factors underlying prescription drug costs and |
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126 | 126 | | 97price increases including, but not limited to, the initial prices of drugs coming to market and |
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127 | 127 | | 98subsequent price increases, changes in industry profit levels, marketing expenses, reverse |
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128 | 128 | | 99payment patent settlements, the impact of manufacturer rebates, discounts and other price 6 of 29 |
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129 | 129 | | 100concessions on net pricing, the availability of alternative drugs or treatments and any other |
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130 | 130 | | 101matters as determined by the commission. |
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131 | 131 | | 102 SECTION 14. Subsection (g) of said section 8 of said chapter 6D, as so appearing, is |
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132 | 132 | | 103hereby amended by striking out the second sentence and inserting in place thereof the following |
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133 | 133 | | 104sentence:- The report shall be based on the commission’s analysis of information provided at the |
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134 | 134 | | 105hearings by witnesses, providers, provider organizations, payers, pharmaceutical manufacturing |
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135 | 135 | | 106companies and pharmacy benefit managers, registration data collected under section 11, data |
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136 | 136 | | 107collected or analyzed by the center under sections 8, 9, 10, and 10A of chapter 12C and any other |
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137 | 137 | | 108available information that the commission considers necessary to fulfill its duties under this |
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138 | 138 | | 109section as defined in regulations promulgated by the commission. |
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139 | 139 | | 110 SECTION 15. Section 9 of said chapter 6D, as so appearing, is hereby amended by |
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140 | 140 | | 111inserting after the word “organization”, in line 72, the following words:- , pharmacy benefit |
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141 | 141 | | 112manager, pharmaceutical manufacturing company. |
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142 | 142 | | 113 SECTION 16. Said chapter 6D, as so appearing, is hereby further amended by adding the |
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143 | 143 | | 114following section: |
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144 | 144 | | 115 Section 20. (a) For the purposes of this section, “Manufacturer” shall mean an entity that |
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145 | 145 | | 116manufactures a pharmaceutical drug. |
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146 | 146 | | 117 (b) The commission may require a manufacturer specified in subsection (c) to disclose to |
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147 | 147 | | 118the commission within a reasonable time information relating to the manufacturer’s pricing of |
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148 | 148 | | 119that drug, on a standard reporting form developed by the commission with the input of the |
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149 | 149 | | 120manufacturers, which includes, but shall not be limited to, the following: 7 of 29 |
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150 | 150 | | 121 (1) A schedule of the drug’s wholesale acquisition cost increases over the previous 5 |
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151 | 151 | | 122calendar years; |
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152 | 152 | | 123 (2) The manufacturer’s aggregate, company-level research and development and other |
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153 | 153 | | 124relevant capital expenditures, including facility construction, for the most recent year for which |
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154 | 154 | | 125final audited data are available; |
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155 | 155 | | 126 (3) A written, narrative description, suitable for public release, of factors that contributed |
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156 | 156 | | 127to reported changes in wholesale acquisition cost during the previous 5 calendar years; and |
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157 | 157 | | 128 (4) Any other information that the manufacturer wishes to provide to the commission. |
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158 | 158 | | 129 Based on the records furnished, the commission may identify a proposed value for a |
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159 | 159 | | 130prescribed drug specified in subsection (c). The Commission may request additional relevant |
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160 | 160 | | 131information that it deems necessary. |
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161 | 161 | | 132 (c) A manufacturer of a drug for which the commission has received a referral from the |
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162 | 162 | | 133center under subsection (b) of section 25 of chapter 12C shall comply with the requirements set |
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163 | 163 | | 134forth in this section; provided that the commission may select or prioritize a subset of the |
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164 | 164 | | 135referred drugs for the commission’s review. |
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165 | 165 | | 136 (d) Records disclosed by a manufacturer under this section shall: (i) be accompanied by |
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166 | 166 | | 137an attestation that all information provided is true and correct; (ii) not be public records under |
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167 | 167 | | 138section 7 of chapter 4 or chapter 66; and (iii) remain confidential; provided, however, that the |
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168 | 168 | | 139commission may produce reports summarizing any findings; provided that any such report shall |
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169 | 169 | | 140not be in a form that identifies specific prices charged for or rebate amounts associated with 8 of 29 |
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170 | 170 | | 141drugs by a manufacturer, or in a manner that is likely to compromise the financial, competitive or |
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171 | 171 | | 142proprietary nature of the information. |
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172 | 172 | | 143 (e) If, after review of any records furnished to the commission under subsection (b), the |
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173 | 173 | | 144commission determines that the manufacturer’s pricing of the drug is potentially unreasonable or |
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174 | 174 | | 145excessive in relation to the commission’s proposed value under subsection (b), the commission |
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175 | 175 | | 146shall require that the manufacturer provide within 30 days further information related to the |
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176 | 176 | | 147pricing of the prescribed drug and the manufacturer’s justification for the pricing. In addition to |
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177 | 177 | | 148the manufacturer, the commission may identify other relevant parties including but not limited to |
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178 | 178 | | 149patients, providers, provider organizations and payers who may provide information to the |
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179 | 179 | | 150commission. |
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180 | 180 | | 151 (f) The commission shall provide to the manufacturer for review and input any |
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181 | 181 | | 152information, analyses or reports regarding a particular drug reviewed or relied on by the |
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182 | 182 | | 153commission in assessing the proposed value of the drug shall be provided to the manufacturer. |
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183 | 183 | | 154The commission shall consider any clarifications or data provided by the manufacturer with |
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184 | 184 | | 155respect to its drug. The commission may not rely solely on the analysis or research of an outside |
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185 | 185 | | 156third party in reaching its determination regarding the proposed value or the reasonableness of |
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186 | 186 | | 157the drug pricing. |
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187 | 187 | | 158 (g) If the commission relies upon a third party to provide cost-effectiveness analysis or |
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188 | 188 | | 159research related to the proposed value, such analysis or research shall also provide, without |
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189 | 189 | | 160limitation (i) a description of the methodologies and models used by the third party in its |
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190 | 190 | | 161analysis; (ii) any assumptions and potential limitations of research findings in the context of the |
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191 | 191 | | 162results; and (iii) outcomes for affected subpopulations that utilize the drug, including but not 9 of 29 |
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192 | 192 | | 163limited to potential impacts on individuals of minority racial or ethnic groups, and on individuals |
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193 | 193 | | 164with specific disabilities or health conditions who regularly utilize the eligible drug. |
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194 | 194 | | 165 (h) Not later than 60 days after receiving information from the manufacturer, as required |
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195 | 195 | | 166under subsections (b) or (e), the commission shall issue a determination on whether the |
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196 | 196 | | 167manufacturer’s pricing of a drug is unreasonable or excessive in relation to the commission’s |
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197 | 197 | | 168proposed value of the drug. Following the determination, the commission shall issue |
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198 | 198 | | 169recommendations on measures to reduce the cost of the drug and to improve the affordability of |
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199 | 199 | | 170the drug for patients. Recommendations may include, but not be limited to: (i) an alternative |
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200 | 200 | | 171purchasing plan or value-based payment methodology; (ii) a bulk purchasing program; (iii) |
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201 | 201 | | 172changes to co-pay, deductibles, coinsurance or other cost-sharing requirements; or (iv) a |
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202 | 202 | | 173reinsurance program to subsidize the cost of the eligible drug. The commission shall make its |
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203 | 203 | | 174determination and recommendations public and shall post them on its website and shall provide |
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204 | 204 | | 175them to private and public health care payers. |
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205 | 205 | | 176 (i) If the manufacturer fails to timely comply with the commission’s request for records |
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206 | 206 | | 177under subsections (b) or (e), or otherwise knowingly obstructs the commission’s ability to issue |
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207 | 207 | | 178its determination under subsection (h), including, but not limited to, providing incomplete, false |
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208 | 208 | | 179or misleading information, the commission may assess a civil penalty to a manufacturer of not |
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209 | 209 | | 180more than $500,000. A civil penalty assessed under this subsection shall be deposited into the |
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210 | 210 | | 181Payment Reform Fund established pursuant to section 100 of chapter 194 of the acts of 2011. |
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211 | 211 | | 182The commission shall seek to promote compliance with this section and shall only impose a civil |
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212 | 212 | | 183penalty on the manufacturer as a last resort. 10 of 29 |
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213 | 213 | | 184 (j) Neither the proposed value, nor the analysis produced via the process to determine a |
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214 | 214 | | 185proposed value, is intended to be used by MassHealth, health insurance carriers, managed care |
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215 | 215 | | 186organizations, accountable care organizations, hospitals or pharmacies to determine whether a |
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216 | 216 | | 187treatment should be approved for an individual patient, whether any individual patient should be |
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217 | 217 | | 188subjected to step therapy or other utilization management methodology, |
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218 | 218 | | 189 (k) The commission shall adopt any written policies, procedures or regulations that the |
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219 | 219 | | 190commission determines necessary to implement this section. |
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220 | 220 | | 191 SECTION 17. Section 11N of chapter 12 of the General Laws, as so appearing, is hereby |
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221 | 221 | | 192amended by striking out subsection (a) and inserting in place thereof the following subsection:- |
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222 | 222 | | 193 (a) The attorney general shall monitor trends in the health care market including, but not |
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223 | 223 | | 194limited to, trends in provider organization size and composition, consolidation in the provider |
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224 | 224 | | 195market, payer contracting trends, patient access and quality issues in the health care market and |
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225 | 225 | | 196prescription drug cost trends. The attorney general may obtain the following information from a |
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226 | 226 | | 197private health care payer, public health care payer, pharmaceutical manufacturing company, |
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227 | 227 | | 198pharmacy benefit manager, provider or provider organization as any of those terms may be |
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228 | 228 | | 199defined in section 1 of chapter 6D: (i) any information that is required to be submitted under |
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229 | 229 | | 200sections 8, 9 10 and 10A of chapter 12C; (ii) filings, applications and supporting documentation |
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230 | 230 | | 201related to any cost and market impact review under section 13 of said chapter 6D; (iii) filings, |
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231 | 231 | | 202applications and supporting documentation related to a determination of need application filed |
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232 | 232 | | 203under section 25C of chapter 111; and (iv) filings, applications and supporting documentation |
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233 | 233 | | 204submitted to the federal Centers for Medicare and Medicaid Services or the Office of the |
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234 | 234 | | 205Inspector General for any demonstration project. Under section 17 of said chapter 12C and 11 of 29 |
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235 | 235 | | 206section 8 of said chapter 6D and subject to the limitations stated in those sections, the attorney |
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236 | 236 | | 207general may require that any provider, provider organization, pharmaceutical manufacturing |
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237 | 237 | | 208company, pharmacy benefit manager, private health care payer or public health care payer |
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238 | 238 | | 209produce documents, answer interrogatories and provide testimony under oath related to health |
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239 | 239 | | 210care costs and cost trends, pharmaceutical costs, pharmaceutical cost trends, the factors that |
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240 | 240 | | 211contribute to cost growth within the commonwealth's health care system and the relationship |
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241 | 241 | | 212between provider costs and payer premium rates and the relationship between pharmaceutical |
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242 | 242 | | 213drug costs and payer premium rates. |
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243 | 243 | | 214 SECTION 18. Section 1 of chapter 12C of the General Laws, as so appearing, is hereby |
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244 | 244 | | 215amended by inserting after the definition of “Ambulatory surgical center services” the following |
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245 | 245 | | 2163 definitions:- |
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246 | 246 | | 217 “Average manufacturer price”, the average price paid to a manufacturer for a drug in the |
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247 | 247 | | 218commonwealth by a wholesaler for drugs distributed to pharmacies and by a pharmacy that |
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248 | 248 | | 219purchases drugs directly from the manufacturer. |
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249 | 249 | | 220 “Biosimilar”, a drug that is produced or distributed pursuant to a biologics license |
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250 | 250 | | 221application approved under 42 U.S.C. 262(k)(3). |
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251 | 251 | | 222 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new |
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252 | 252 | | 223drug application approved under 21 U.S.C. §355(c) except for an authorized generic as defined |
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253 | 253 | | 224by 42 C.F.R. § 447.502; (ii) produced or distributed pursuant to a biologics license application |
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254 | 254 | | 225approved under 42 U.S.C. § 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand |
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255 | 255 | | 226name drug based on available data resources such as Medi-Span. 12 of 29 |
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256 | 256 | | 227 SECTION 19. Said section 1 of said chapter 12C, as so appearing, is hereby further |
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257 | 257 | | 228amended by inserting after the definition of “General health supplies, care or rehabilitative |
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258 | 258 | | 229services and accommodations” the following definition:- |
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259 | 259 | | 230 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an |
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260 | 260 | | 231abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic as |
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261 | 261 | | 232defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962 that |
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262 | 262 | | 233was not originally marketed under a new drug application; or (iv) identified by the health benefit |
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263 | 263 | | 234plan as a generic drug based on available data resources such as Medi-Span. |
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264 | 264 | | 235 SECTION 20. Said section 1 of said chapter 12C, as so appearing, is hereby further |
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265 | 265 | | 236amended by inserting after the definition of “Patient-centered medical home” the following 2 |
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266 | 266 | | 237definitions:- |
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267 | 267 | | 238 “Pharmaceutical manufacturing company”, an entity engaged in the: (i) production, |
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268 | 268 | | 239preparation, propagation, compounding, conversion or processing of prescription drugs, directly |
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269 | 269 | | 240or indirectly, by extraction from substances of natural origin, independently by means of |
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270 | 270 | | 241chemical synthesis or by a combination of extraction and chemical synthesis; or (ii) packaging, |
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271 | 271 | | 242repackaging, labeling, relabeling or distribution of prescription drugs; provided, however, that |
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272 | 272 | | 243“pharmaceutical manufacturing company” shall not include a wholesale drug distributor licensed |
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273 | 273 | | 244under section 36B of chapter 112 or a retail pharmacist registered under section 39 of said |
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274 | 274 | | 245chapter 112. |
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275 | 275 | | 246 “Pharmacy benefit manager”, a person, business or other entity, however organized, that, |
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276 | 276 | | 247directly or through a subsidiary, provides pharmacy benefit management services for prescription |
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277 | 277 | | 248drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self- 13 of 29 |
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278 | 278 | | 249insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit |
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279 | 279 | | 250management services shall include, but not be limited to, the processing and payment of claims |
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280 | 280 | | 251for prescription drugs, the performance of drug utilization review, the processing of drug prior |
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281 | 281 | | 252authorization requests, pharmacy contracting, the adjudication of appeals or grievances related to |
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282 | 282 | | 253prescription drug coverage contracts, formulary administration, drug benefit design, mail and |
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283 | 283 | | 254specialty drug pharmacy services, cost containment, clinical, safety and adherence programs for |
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284 | 284 | | 255pharmacy services and managing the cost of covered prescription drugs; provided further, that |
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285 | 285 | | 256“pharmacy benefit manager” shall include a health benefit plan that does not contract with a |
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286 | 286 | | 257pharmacy benefit manager and manages its own prescription drug benefits unless specifically |
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287 | 287 | | 258exempted by the commission. |
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288 | 288 | | 259 SECTION 21. Said section 1 of said chapter 12C, as so appearing, is hereby further |
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289 | 289 | | 260amended by adding the following definition:- |
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290 | 290 | | 261 “Wholesale acquisition cost”, shall have the same meaning as defined in 42 U.S.C. |
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291 | 291 | | 2621395w-3a(c)(6)(B). |
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292 | 292 | | 263 SECTION 22. Section 3 of said chapter 12C, as so appearing, is hereby amended by |
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293 | 293 | | 264inserting after the word “organizations”, in lines 13 and 14, the following words:- , |
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294 | 294 | | 265pharmaceutical manufacturing companies, pharmacy benefit managers. |
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295 | 295 | | 266 SECTION 23. Said section 3 of said chapter 12C, as so appearing, is hereby further |
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296 | 296 | | 267amended by striking out, in line 24, the words “and payer” and inserting in place thereof the |
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297 | 297 | | 268following words:- , payer, pharmaceutical manufacturing company and pharmacy benefit |
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298 | 298 | | 269manager. 14 of 29 |
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299 | 299 | | 270 SECTION 24. Section 5 of said chapter 12C, as so appearing, is hereby amended by |
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300 | 300 | | 271striking out, in lines 11 and 12, the words “and public health care payers” and inserting in place |
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301 | 301 | | 272thereof the following words:- , public health care payers, pharmaceutical manufacturing |
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302 | 302 | | 273companies and pharmacy benefit managers. |
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303 | 303 | | 274 SECTION 25. Said section 5 of said chapter 12C, as so appearing, is hereby further |
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304 | 304 | | 275amended by striking out, in line 15, the words “and affected payers” and inserting in place |
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305 | 305 | | 276thereof the following words:- affected payers, affected pharmaceutical manufacturing companies |
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306 | 306 | | 277and affected pharmacy benefit managers. |
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307 | 307 | | 278 SECTION 26. The first paragraph of section 7 of said chapter 12C, as so appearing, is |
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308 | 308 | | 279hereby amended by adding the following sentence:- |
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309 | 309 | | 280 Each pharmaceutical and biopharmaceutical manufacturing company and pharmacy |
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310 | 310 | | 281benefit manager shall pay to the commonwealth an amount for the estimated expenses of the |
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311 | 311 | | 282center and for the other purposes described in this chapter. |
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312 | 312 | | 283 SECTION 27. Said section 7 of said chapter 12C, as so appearing, is hereby further |
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313 | 313 | | 284amended by striking out, in lines 8 and 42, the figure “33” and inserting in place thereof, in each |
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314 | 314 | | 285instance, the following figure:- 25. |
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315 | 315 | | 286 SECTION 28. Said section 7 of said chapter 12C, as so appearing, is hereby further |
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316 | 316 | | 287amended by adding the following paragraph:- |
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317 | 317 | | 288 The assessed amount for pharmaceutical and biopharmaceutical manufacturing |
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318 | 318 | | 289companies and pharmacy benefit managers shall be not less than 25 per cent of the amount |
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319 | 319 | | 290appropriated by the general court for the expenses of the center minus amounts collected from: 15 of 29 |
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320 | 320 | | 291(i) filing fees; (ii) fees and charges generated by the commission's publication or dissemination |
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321 | 321 | | 292of reports and information; and (iii) federal matching revenues received for these expenses or |
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322 | 322 | | 293received retroactively for expenses of predecessor agencies. Pharmaceutical and |
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323 | 323 | | 294biopharmaceutical manufacturing companies and pharmacy benefit managers shall, in a manner |
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324 | 324 | | 295and distribution determined by the center, pay to the commonwealth an amount of the estimated |
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325 | 325 | | 296expenses of the center attributable to the center’s activities under sections 3, 10A, 12 and 16. A |
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326 | 326 | | 297pharmacy benefit manager that is a surcharge payor subject to the preceding paragraph and |
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327 | 327 | | 298manages its own prescription drug benefits shall not be subject to additional assessment under |
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328 | 328 | | 299this paragraph. |
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329 | 329 | | 300 SECTION 29. Subsection (b) of section 10 of chapter 12C of the General Laws, as so |
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330 | 330 | | 301appearing, is hereby amended by striking out, in line 55, the word “and”. |
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331 | 331 | | 302 SECTION 30. Said subsection (b) of said section 10 of said chapter 12C is hereby further |
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332 | 332 | | 303amended by adding the following words:- ; (12) information about prescription drug utilization |
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333 | 333 | | 304and spending for all covered drugs, including for generic drugs, brand-name drugs, and specialty |
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334 | 334 | | 305drugs provided in an outpatient setting or sold in a retail setting, including but not limited to |
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335 | 335 | | 306information sufficient to show (i) highest utilization drugs, (ii) drugs with the greatest increases |
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336 | 336 | | 307in utilization, (iii) drugs that are most impactful on plan spending, net of rebates, and (iv) drugs |
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337 | 337 | | 308with the highest year-over-year price increases, net of rebates; and (13) information on claims |
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338 | 338 | | 309and non-claims based payments to providers for the provision of primary care and behavioral |
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339 | 339 | | 310health, including mental health and substance use disorder, services, as defined by the center. 16 of 29 |
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340 | 340 | | 311 SECTION 31. Subsection (c) of said section 10 of said chapter 12C, as so appearing, is |
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341 | 341 | | 312hereby amended by striking out, in line 91, the words “()” and inserting in place thereof the |
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342 | 342 | | 313following words:- (10). |
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343 | 343 | | 314 SECTION 32. Said subsection (c) of said section 10 of said chapter 12C, as so appearing, |
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344 | 344 | | 315is hereby further amended by striking out, in line 99, the word “and”. |
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345 | 345 | | 316 SECTION 33. Said subsection (c) of said section 10 of said chapter 12C, as so appearing, |
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346 | 346 | | 317is hereby further amended by adding the following words:- ; (12) information, to the extent |
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347 | 347 | | 318permissible under 42 U.S.C. 1396r-8(b)(3)(D), about prescription drug utilization and spending |
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348 | 348 | | 319for all covered drugs, including for generic drugs, brand-name drugs, and specialty drugs |
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349 | 349 | | 320provided in an outpatient setting or sold in a retail setting, including but not limited to |
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350 | 350 | | 321information sufficient to show (i) highest utilization drugs, (ii) drugs with the greatest increases |
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351 | 351 | | 322in utilization, (iii) drugs that are most impactful on plan spending, net of rebates, and (iv) drugs |
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352 | 352 | | 323with the highest year-over-year price increases, net of rebates; and (13) information on claims |
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353 | 353 | | 324and non-claims based payments to providers for the provision of primary care and behavioral |
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354 | 354 | | 325health, including mental health and substance use disorder services, as defined by the center. |
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355 | 355 | | 326 SECTION 34. Said chapter 12C is hereby further amended by inserting after section 10 |
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356 | 356 | | 327the following section:- |
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357 | 357 | | 328 Section 10A. (a) The center shall promulgate regulations necessary to ensure the uniform |
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358 | 358 | | 329annual reporting of information from pharmacy benefit managers certified under chapter 175N, |
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359 | 359 | | 330including but not limited to information on: (1) prices charged to payers on average by pharmacy |
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360 | 360 | | 331benefits managers for select prescription drug products, net of any rebate, discounts, fees or other |
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361 | 361 | | 332payments from the manufacturer to the pharmacy benefits manager and from the pharmacy 17 of 29 |
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362 | 362 | | 333benefits manager to the manufacturer; (2) payments received by pharmacy benefit managers by |
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363 | 363 | | 334payers related to drugs provided to Massachusetts residents; (3) payments made by pharmacy |
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364 | 364 | | 335benefit managers to pharmacies related to drugs provided to Massachusetts residents; (4) rebates |
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365 | 365 | | 336received by pharmacy benefit managers from drug manufacturers related to drugs provided to |
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366 | 366 | | 337Massachusetts residents; (5) rebates paid by pharmacy benefit managers to payers related to |
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367 | 367 | | 338drugs provided to Massachusetts residents; (6) other payments made or received by pharmacy |
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368 | 368 | | 339benefit managers by payers or pharmacies, including but not limited to administrative or |
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369 | 369 | | 340performance-based payments, related to doing business in Massachusetts; (7) other rebates paid |
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370 | 370 | | 341to or received by pharmacy benefit managers by drug manufacturers or payers related to doing |
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371 | 371 | | 342business in Massachusetts; (8) information about prescription drug utilization and spending for |
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372 | 372 | | 343all covered drugs, including for generic drugs, brand-name drugs, and specialty drugs provided |
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373 | 373 | | 344in an outpatient setting or sold in a retail setting, including but not limited to information |
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374 | 374 | | 345sufficient to show: (i) highest utilization drugs; (ii) drugs with the greatest increases in |
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375 | 375 | | 346utilization; (iii) drugs that are most impactful on plan spending, net of rebates; and (iv) drugs |
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376 | 376 | | 347with the highest year-over-year price increases, net of rebates; (9) the Medicare Maximum Fair |
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377 | 377 | | 348Price (42USC Sec 1191(c)) for a prescription drug; and (10) any other information deemed |
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378 | 378 | | 349necessary by the center. |
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379 | 379 | | 350 (b) The center shall analyze the information and data collected under subsection (a) and |
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380 | 380 | | 351shall publish an annual report summarizing, at minimum, the information collected under |
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381 | 381 | | 352subsection (a) and comparing the information as it relates to each pharmacy benefit manager |
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382 | 382 | | 353certified under chapter 175N with respect to drugs provided to Massachusetts residents. The |
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383 | 383 | | 354center may also consult with other states collecting similar data to inform their analysis and |
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384 | 384 | | 355annual report. 18 of 29 |
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385 | 385 | | 356 (c) Except as provided otherwise by the center or under this chapter, pharmacy benefit |
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386 | 386 | | 357manager data collected by the center under this section shall not be a public record under clause |
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387 | 387 | | 358Twenty-sixth of section 7 of chapter 4 or under chapter 66. The center may confidentially |
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388 | 388 | | 359provide pharmacy benefit manager data collected by the center under this section to the health |
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389 | 389 | | 360policy commission. |
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390 | 390 | | 361 SECTION 35. Said chapter 12C is hereby further amended by striking out section 11, as |
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391 | 391 | | 362so appearing, and inserting in place thereof the following section:- |
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392 | 392 | | 363 Section 11. The center shall ensure the timely reporting of information required under |
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393 | 393 | | 364sections 8, 9, 10 and 10A. The center shall notify payers, providers, provider organizations, |
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394 | 394 | | 365pharmacy benefit managers and pharmaceutical manufacturing companies of any applicable |
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395 | 395 | | 366reporting deadlines. The center shall notify, in writing, a private health care payer, provider, |
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396 | 396 | | 367provider organization, pharmacy benefit manager or pharmaceutical manufacturing company that |
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397 | 397 | | 368it has failed to meet a reporting deadline and that failure to respond within 2 weeks of the receipt |
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398 | 398 | | 369of the notice may result in penalties. The center may assess a penalty against a private health care |
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399 | 399 | | 370payer, provider, provider organization, pharmacy benefit manager or pharmaceutical |
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400 | 400 | | 371manufacturing company that fails, without just cause, to provide the requested information |
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401 | 401 | | 372within 2 weeks following receipt of the written notice required under this section of not more |
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402 | 402 | | 373than $2,000 per week for each week of delay after the 2-week period following receipt of the |
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403 | 403 | | 374written notice. Amounts collected under this section shall be deposited in the Healthcare |
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404 | 404 | | 375Payment Reform Fund established in section 100 of chapter 194 of the acts of 2011. 19 of 29 |
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405 | 405 | | 376 SECTION 36. Section 12 of said chapter 12C, as so appearing, is hereby amended by |
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406 | 406 | | 377striking out, in line 2, the words “and 10” and inserting in place thereof the following words:- , |
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407 | 407 | | 37810 and 10A. |
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408 | 408 | | 379 SECTION 37. Subsection (a) of section 16 of said chapter 12C, as so appearing, is hereby |
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409 | 409 | | 380amended by striking out the first sentence and inserting in place thereof the following sentence:- |
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410 | 410 | | 381 The center shall publish an annual report based on the information submitted under: (i) |
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411 | 411 | | 382sections 8, 9, 10 and 10A concerning health care provider, provider organization, private and |
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412 | 412 | | 383public health care payer, pharmaceutical manufacturing company and pharmacy benefit manager |
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413 | 413 | | 384costs and cost and price trends; (ii) section 13 of chapter 6D relative to market power reviews; |
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414 | 414 | | 385and (iii) section 15 of said chapter 6D relative to quality data. |
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415 | 415 | | 386 SECTION 38. Said chapter 12C is hereby further amended by striking out section 17, as |
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416 | 416 | | 387so appearing, and inserting in place thereof the following section:- |
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417 | 417 | | 388 Section 17. The attorney general may review and analyze any information submitted to |
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418 | 418 | | 389the center under sections 8, 9, 10 and 10A and the health policy commission under section 8 of |
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419 | 419 | | 390chapter 6D. The attorney general may require that any provider, provider organization, |
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420 | 420 | | 391pharmaceutical manufacturing company, pharmacy benefit manager or payer produce |
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421 | 421 | | 392documents, answer interrogatories and provide testimony under oath related to health care costs |
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422 | 422 | | 393and cost trends, pharmaceutical cost trends, factors that contribute to cost growth within the |
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423 | 423 | | 394commonwealth's health care system and the relationship between provider costs and payer |
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424 | 424 | | 395premium rates. The attorney general shall keep confidential all nonpublic information and |
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425 | 425 | | 396documents obtained under this section and shall not disclose the information or documents to any |
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426 | 426 | | 397person without the consent of the provider, pharmaceutical manufacturing company, pharmacy 20 of 29 |
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427 | 427 | | 398benefit manager or payer that produced the information or documents except in a public hearing |
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428 | 428 | | 399under said section 8 of said chapter 6D, a rate hearing before the division of insurance or in a |
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429 | 429 | | 400case brought by the attorney general, if the attorney general believes that such disclosure will |
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430 | 430 | | 401promote the health care cost containment goals of the commonwealth and that the disclosure |
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431 | 431 | | 402shall be made in the public interest after taking into account any privacy, trade secret or |
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432 | 432 | | 403anticompetitive considerations. The confidential information and documents shall not be public |
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433 | 433 | | 404records and shall be exempt from disclosure under clause Twenty-sixth of section 7 of chapter 4 |
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434 | 434 | | 405or section 10 of chapter 66. |
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435 | 435 | | 406 SECTION 39. Said chapter 12C is hereby further amended by adding the following |
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436 | 436 | | 407section:- |
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437 | 437 | | 408 Section 25. (a) The center shall analyze data on Massachusetts drug utilization and |
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438 | 438 | | 409spending, including but not limited to data reported under Sections 10 and 10A. Annually, the |
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439 | 439 | | 410center shall refer drugs to the health policy commission for review under section 8B of chapter |
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440 | 440 | | 4116D that meet any of the following criteria: (i) a current average annual gross cost per utilizer for |
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441 | 441 | | 412public and private health care payers in Massachusetts of greater than $50,000; (ii) a biosimilar |
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442 | 442 | | 413drug that has a launch wholesale acquisition cost that is not at least 15 per cent lower than the |
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443 | 443 | | 414referenced brand biologic at the time the biosimilar is launched; or (iii) among the 25 drugs |
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444 | 444 | | 415determined by the center to have the most impact on health care spending in the most recent year |
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445 | 445 | | 416of available data, based upon utilization, price, utilization and price growth, patient cost sharing |
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446 | 446 | | 417amounts, net spending and other factors as determined by the center. The center shall provide |
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447 | 447 | | 418notice of the referral to the manufacturer of the drug. 21 of 29 |
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448 | 448 | | 419 (b) Not later than May 1, the center shall publish an annual report detailing, at minimum, |
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449 | 449 | | 420each drug referred to the health policy commission under subsection (a). |
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450 | 450 | | 421 (c) The center shall adopt any written policies, procedures or regulations necessary to |
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451 | 451 | | 422implement this section. |
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452 | 452 | | 423 SECTION 40. Chapter 94C of the General Laws is hereby amended by inserting after |
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453 | 453 | | 424section 21B the following section:- |
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454 | 454 | | 425 Section 21C. (a) For the purposes of this section, the following words shall, unless the |
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455 | 455 | | 426context clearly requires otherwise, have the following meanings:- |
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456 | 456 | | 427 “Cost-sharing”, the amount owed by an insured under the terms of the insured’s health |
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457 | 457 | | 428benefit plan or as required by a pharmacy benefit manager, including any copayment, |
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458 | 458 | | 429coinsurance or deductible. |
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459 | 459 | | 430 “Pharmacy retail price”, the amount a pharmacy bills for a prescription medication |
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460 | 460 | | 431regardless of whether the individual purchases that prescription medication at that pharmacy |
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461 | 461 | | 432using a health benefit plan or any other prescription medication benefit or discount. |
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462 | 462 | | 433 “Registered pharmacist”, a pharmacist who holds a valid certificate of registration issued |
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463 | 463 | | 434by the board of registration in pharmacy pursuant to section 24 of chapter 112. |
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464 | 464 | | 435 (b) A health benefit plan shall (1) not restrict, directly or indirectly, any pharmacy that |
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465 | 465 | | 436dispenses a prescription drug to an insured in the plan from informing, or penalize such |
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466 | 466 | | 437pharmacy for informing, an insured of any differential between the insured’s cost-sharing |
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467 | 467 | | 438amount under the plan with respect to acquisition of the drug and the amount an individual |
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468 | 468 | | 439would pay for acquisition of the drug without using any health plan or health insurance coverage; 22 of 29 |
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469 | 469 | | 440and (2) ensure that any pharmacy benefit manager under a contract with any such health benefit |
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470 | 470 | | 441plan does not, with respect to such plan, restrict, directly or indirectly, a pharmacy that dispenses |
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471 | 471 | | 442a prescription drug from informing, or penalize such pharmacy for informing, an insured of any |
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472 | 472 | | 443differential between the insured's cost-sharing amount under the plan with respect to acquisition |
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473 | 473 | | 444of the drug and the amount an individual would pay for acquisition of the drug without using any |
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474 | 474 | | 445health plan or health insurance coverage. |
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475 | 475 | | 446 (c) A health benefit plan or a pharmacy benefit manager may not require an insured to |
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476 | 476 | | 447make a payment at the point of sale for a covered prescription medication in an amount greater |
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477 | 477 | | 448than the lesser of: (i) the applicable copayment for the prescription medication; (ii) the allowable |
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478 | 478 | | 449claim amount for the prescription medication; (iii) the amount an insured would pay for the |
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479 | 479 | | 450prescription medication if the insured purchased the prescription medication without using a |
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480 | 480 | | 451health benefit plan or any other source of prescription medication benefits or discounts, to the |
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481 | 481 | | 452extent this information is available to the health benefit plan; or (iv) the amount the pharmacy |
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482 | 482 | | 453will be reimbursed for the drug from pharmacy benefit manager or health benefit plan. |
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483 | 483 | | 454 (d) A pharmacy shall affirmatively inform consumers that a consumer may request, at the |
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484 | 484 | | 455point of sale, the current pharmacy retail price for each prescription medication the consumer |
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485 | 485 | | 456intends to purchase. The pharmacy shall provide the information through verbal indication, |
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486 | 486 | | 457posting of a notice, or other methods. If the consumer’s cost-sharing amount for a prescription |
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487 | 487 | | 458medication exceeds the current pharmacy retail price, the pharmacist, or an authorized individual |
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488 | 488 | | 459at the direction of a pharmacist, shall notify the consumer that the pharmacy retail price is less |
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489 | 489 | | 460than the patient’s cost-sharing amount. The pharmacist shall charge the consumer the applicable |
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490 | 490 | | 461cost-sharing amount or the current pharmacy retail price for that prescription medication, as |
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491 | 491 | | 462directed by the consumer. 23 of 29 |
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492 | 492 | | 463 (e) A contractual obligation shall not prohibit a pharmacist from complying with this |
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493 | 493 | | 464section; provided, however, that a pharmacist shall submit a claim to the insured’s health benefit |
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494 | 494 | | 465plan or its pharmacy benefit manager if the pharmacist has knowledge that the prescription |
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495 | 495 | | 466medication is covered under the insured’s health benefit plan. |
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496 | 496 | | 467 (f) A health benefit plan or pharmacy benefit manager shall not penalize, require, or |
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497 | 497 | | 468provide financial incentives, including variations in premiums, deductibles, copayments, or |
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498 | 498 | | 469coinsurance, to insureds as incentives to use specific retail, mail order pharmacy, or other |
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499 | 499 | | 470network pharmacy provider in which a pharmacy benefit manager has an ownership interest or |
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500 | 500 | | 471that has an ownership interest in a pharmacy benefit manager. |
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501 | 501 | | 472 (g) A violation of this section shall be an unfair or deceptive act or practice under chapter |
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502 | 502 | | 47393A. |
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503 | 503 | | 474 SECTION 41. Section 226 of chapter 175 of the General Laws, as appearing in the 2018 |
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504 | 504 | | 475Official Edition, is hereby amended by striking out subsection (a) and inserting in place thereof |
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505 | 505 | | 476the following subsection:- |
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506 | 506 | | 477 (a) For the purposes of this section, the term “pharmacy benefit manager” shall mean a |
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507 | 507 | | 478person, business or other entity, however organized, that, directly or through a subsidiary, |
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508 | 508 | | 479provides pharmacy benefit management services for prescription drugs and devices on behalf of |
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509 | 509 | | 480a health benefit plan sponsor, including, but not limited to, a self-insurance plan, labor union or |
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510 | 510 | | 481other third-party payer; provided, however, that pharmacy benefit management services shall |
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511 | 511 | | 482include, but not be limited to, the processing and payment of claims for prescription drugs, the |
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512 | 512 | | 483performance of drug utilization review, the processing of drug prior authorization requests, |
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513 | 513 | | 484pharmacy contracting, the adjudication of appeals or grievances related to prescription drug 24 of 29 |
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514 | 514 | | 485coverage contracts, formulary administration, drug benefit design, mail and specialty drug |
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515 | 515 | | 486pharmacy services, cost containment, clinical, safety and adherence programs for pharmacy |
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516 | 516 | | 487services and managing the cost of covered prescription drugs; provided further, that “pharmacy |
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517 | 517 | | 488benefit manager” shall include a health benefit plan that does not contract with a pharmacy |
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518 | 518 | | 489benefit manager and manages its own prescription drug benefits unless specifically exempted. |
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519 | 519 | | 490 SECTION 42. Section 2 of Chapter 176O of the General Laws, as so appearing, is hereby |
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520 | 520 | | 491amended by adding the following subsection:- |
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521 | 521 | | 492 (i) At least annually, a carrier that contracts with a pharmacy benefit manager shall |
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522 | 522 | | 493coordinate an audit of the operations of the pharmacy benefit manager to ensure compliance with |
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523 | 523 | | 494this chapter and to examine the pricing and rebates applicable to prescription drugs that are |
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524 | 524 | | 495provided to the carrier’s covered persons. |
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525 | 525 | | 496 SECTION 43. Said chapter 176O of the General Laws is hereby further amended by |
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526 | 526 | | 497inserting after section 22 the following section:- |
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527 | 527 | | 498 Section 22A. Notwithstanding any other general or special law to the contrary, each |
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528 | 528 | | 499carrier shall require that a pharmacy benefit manager receive a license from the division under |
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529 | 529 | | 500chapter 176X as a condition of contracting with that carrier. |
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530 | 530 | | 501 SECTION 44. The General Laws are hereby amended by inserting after chapter 176W |
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531 | 531 | | 502the following chapter:- |
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532 | 532 | | 503 Chapter 176X. |
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533 | 533 | | 504 LICENSING AND REGULATION OF PHARMACY BENEFIT MANAGERS. 25 of 29 |
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534 | 534 | | 505 Section 1. As used in this chapter, the following words shall have the following meanings |
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535 | 535 | | 506unless the context clearly requires otherwise: |
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536 | 536 | | 507 “Carrier”, an insurer licensed or otherwise authorized to transact accident or health |
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537 | 537 | | 508insurance under chapter 175, a nonprofit hospital service corporation organized under chapter |
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538 | 538 | | 509176A, a non-profit medical service corporation organized under chapter 176B, a health |
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539 | 539 | | 510maintenance organization organized under chapter 176G and an organization entering into a |
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540 | 540 | | 511preferred provider arrangement under chapter 176I; provided, however, that the term “carrier” |
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541 | 541 | | 512shall not include an employer purchasing coverage or acting on behalf of its employees or the |
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542 | 542 | | 513employees of any subsidiary or affiliated corporation of the employer; provided further, that |
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543 | 543 | | 514unless otherwise noted the term “carrier” shall not include any entity to the extent it offers a |
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544 | 544 | | 515policy, certificate or contract that provides coverage solely for dental care services or vision care |
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545 | 545 | | 516services. |
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546 | 546 | | 517 “Center”, the center for health information and analysis established in chapter 12C. |
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547 | 547 | | 518 “Commissioner”, the commissioner of insurance. |
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548 | 548 | | 519 “Division”, the division of insurance. |
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549 | 549 | | 520 “Health benefit plan”, a contract, certificate or agreement entered into, offered or issued |
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550 | 550 | | 521by a carrier to provide, deliver, arrange for, pay for or reimburse any of the costs of health care |
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551 | 551 | | 522services; provided, however, that the commissioner may by regulation define other health |
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552 | 552 | | 523coverage as a health benefit plan for the purposes of this chapter. 26 of 29 |
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553 | 553 | | 524 “Pharmacy”, a physical or electronic facility under the direction or supervision of a |
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554 | 554 | | 525registered pharmacist that is authorized to dispense prescription drugs and has entered into a |
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555 | 555 | | 526network contract with a pharmacy benefit manager or a carrier. |
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556 | 556 | | 527 “Pharmacy benefit manager”, a person, business or other entity, however organized, that, |
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557 | 557 | | 528directly or through a subsidiary, provides pharmacy benefit management services for prescription |
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558 | 558 | | 529drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self- |
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559 | 559 | | 530insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit |
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560 | 560 | | 531management services shall include, but not be limited to, the processing and payment of claims |
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561 | 561 | | 532for prescription drugs, the performance of drug utilization review, the processing of drug prior |
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562 | 562 | | 533authorization requests, pharmacy contracting, the adjudication of appeals or grievances related to |
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563 | 563 | | 534prescription drug coverage contracts, formulary administration, drug benefit design, mail and |
---|
564 | 564 | | 535specialty drug pharmacy services, cost containment, clinical, safety and adherence programs for |
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565 | 565 | | 536pharmacy services and managing the cost of covered prescription drugs; provided further, that |
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566 | 566 | | 537“pharmacy benefit manager” shall not include a health benefit plan unless otherwise specified by |
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567 | 567 | | 538the division. |
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568 | 568 | | 539 Section 2. (a) A person, business or other entity shall not establish or operate as a |
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569 | 569 | | 540pharmacy benefit manager in the commonwealth without obtaining a license from the division |
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570 | 570 | | 541pursuant to this section. The division shall issue a pharmacy benefit manager license to a person, |
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571 | 571 | | 542business or other entity that demonstrates to the division that it has the necessary organization, |
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572 | 572 | | 543background expertise and financial integrity to maintain such a license. A pharmacy benefit |
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573 | 573 | | 544manager license shall be valid for a period of 3 years and shall be renewable for additional 3- |
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574 | 574 | | 545year periods. Initial application and renewal fees for the license shall be established pursuant to |
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575 | 575 | | 546section 3B of chapter 7. 27 of 29 |
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576 | 576 | | 547 (b) A license granted pursuant to this section and any rights or interests therein shall not |
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577 | 577 | | 548be transferable. |
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578 | 578 | | 549 (c) A person, business or other entity licensed as a pharmacy benefit manager shall |
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579 | 579 | | 550submit data and reporting information to the center according to the standards and methods |
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580 | 580 | | 551specified by the center pursuant to section 10A of chapter 12C. |
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581 | 581 | | 552 (d) The division may issue or renew a license subject to restrictions in order to protect the |
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582 | 582 | | 553interests of consumers. Such restrictions may include limiting the type of services that a license |
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583 | 583 | | 554holder may provide, limiting the activities in which the license holder may be engaged or |
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584 | 584 | | 555addressing conflicts of interest between pharmacy benefit managers and health plan sponsors. |
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585 | 585 | | 556 (e) The division shall develop an application for licensure that shall include, but not be |
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586 | 586 | | 557limited to: (1) the name of the pharmacy benefit manager; (2) the address and contact telephone |
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587 | 587 | | 558number for the pharmacy benefit manager; (3) the name and address of the pharmacy benefit |
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588 | 588 | | 559manager’s agent for service of process in the commonwealth; (4) the name and address of each |
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589 | 589 | | 560person with management or control over the pharmacy benefit manager; and (5) any audited |
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590 | 590 | | 561financial statements specific to the pharmacy benefit manager. A pharmacy benefit manager |
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591 | 591 | | 562shall report to the division any material change to the information contained in its application, |
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592 | 592 | | 563certified by an officer of the pharmacy benefit manager, within 30 days of such a change. |
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593 | 593 | | 564 (f) The division may suspend, revoke, refuse to issue or renew or place on probation a |
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594 | 594 | | 565pharmacy benefit manager license for cause, which shall include, but not be limited to: (1) the |
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595 | 595 | | 566pharmacy benefit manager engaging in fraudulent activity that constitutes a violation of state or |
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596 | 596 | | 567federal law; (2) the division receiving consumer complaints that justify an action under this |
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597 | 597 | | 568chapter to protect the health, safety and interests of consumers; (3) the pharmacy benefit 28 of 29 |
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598 | 598 | | 569manager failing to pay an application or renewal fee for a license; (4) the pharmacy benefit |
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599 | 599 | | 570manager failing to comply with reporting requirements of the center under section 10A of |
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600 | 600 | | 571chapter 12C; or (5) the pharmacy benefit manager failing to comply with a requirement of this |
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601 | 601 | | 572chapter. |
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602 | 602 | | 573 The division shall provide written notice to the pharmacy benefit manager and advise in |
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603 | 603 | | 574writing of the reason for any suspension, revocation, refusal to issue or renew or placement on |
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604 | 604 | | 575probation of a pharmacy benefit manager license under this chapter. A copy of the notice shall be |
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605 | 605 | | 576forwarded to the center. The applicant or pharmacy benefit manager may make written demand |
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606 | 606 | | 577upon the division within 30 days of receipt of such notification for a hearing before the division |
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607 | 607 | | 578to determine the reasonableness of the division’s action. The hearing shall be held pursuant to |
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608 | 608 | | 579chapter 30A. |
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609 | 609 | | 580 The division shall not suspend or cancel a license unless the division has first afforded |
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610 | 610 | | 581the pharmacy benefit manager an opportunity for a hearing pursuant to said chapter 30A. |
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611 | 611 | | 582 (g) If a person, business or other entity performs the functions of a pharmacy benefit |
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612 | 612 | | 583manager in violation of this chapter, the person, business or other entity shall be subject to a fine |
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613 | 613 | | 584of $5,000 per day for each day that the person, business or other entity is found to be in violation. |
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614 | 614 | | 585 (h) A pharmacy benefit manager shall be required to submit to periodic audits by a carrier |
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615 | 615 | | 586licensed under chapters 175, 176A, 176B or 176G if the pharmacy benefit manager has entered |
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616 | 616 | | 587into a contract with the carrier to provide pharmacy benefit services to the carrier or its members. |
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617 | 617 | | 588The division may direct or provide specifications for such audits. |
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618 | 618 | | 589 (i) A pharmacy benefit manager licensed under this section shall notify a health carrier |
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619 | 619 | | 590client in writing of any activity, policy, practice contract or arrangement of the pharmacy benefit 29 of 29 |
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620 | 620 | | 591manager that directly or indirectly presents any conflict of interest with the pharmacy benefit |
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621 | 621 | | 592manager’s relationship with or obligation to the health carrier client. |
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