SENATE DOCKET, NO. 2232 FILED ON: 1/20/2023
SENATE . . . . . . . . . . . . . . No. 749
The Commonwealth of Massachusetts
_________________
PRESENTED BY:
Cindy F. Friedman
_________________
To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
Court assembled:
The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
An Act relative to pharmaceutical access, costs and transparency.
_______________
PETITION OF:
NAME: DISTRICT/ADDRESS:
Cindy F. Friedman Fourth Middlesex
Rebecca L. Rausch Norfolk, Worcester and Middlesex 1/24/2023
Susannah M. Whipps 2nd Franklin 1/27/2023
Joanne M. Comerford Hampshire, Franklin and Worcester 1/27/2023
Jack Patrick Lewis 7th Middlesex 1/30/2023
Jason M. Lewis Fifth Middlesex 1/31/2023
Patrick M. O'Connor First Plymouth and Norfolk 2/8/2023
James B. Eldridge Middlesex and Worcester 2/16/2023
Julian Cyr Cape and Islands 2/23/2023
Patricia D. Jehlen Second Middlesex 3/2/2023
Paul R. Feeney Bristol and Norfolk 3/6/2023
Michael O. Moore Second Worcester 3/16/2023
Bruce E. Tarr First Essex and Middlesex 3/27/2023
Carmine Lawrence Gentile 13th Middlesex 4/3/2023
Vanna Howard 17th Middlesex 4/10/2023
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 SENATE DOCKET, NO. 2232 FILED ON: 1/20/2023
SENATE . . . . . . . . . . . . . . No. 749
By Ms. Friedman, a petition (accompanied by bill, Senate, No. 749) of Cindy F. Friedman,
Rebecca L. Rausch, Susannah M. Whipps, Joanne M. Comerford and other members of the
General Court for legislation relative to pharmaceutical access, costs and transparency. Health
Care Financing.
[SIMILAR MATTER FILED IN PREVIOUS SESSION
SEE SENATE, NO. 771 OF 2021-2022.]
The Commonwealth of Massachusetts
_______________
In the One Hundred and Ninety-Third General Court
(2023-2024)
_______________
An Act relative to pharmaceutical access, costs and transparency.
Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
of the same, as follows:
1 SECTION 1. Chapter 6A of the General Laws is hereby amended by adding the
2 following section:-
3 Section 16DD. (a) The following terms shall have the following meanings, unless the
4 context clearly requires otherwise:
5 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
6 drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
7 application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
8 is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
9 Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
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10 application that was approved by the United States Secretary of Health and Human Services
11 under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the 2
12 of 53 date of the enactment of the federal Drug Price Competition and Patent Term Restoration
13 Act of 1984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by
14 42 C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application
15 approved under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand
16 name drug based on available data resources such as Medi-Span.
17 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
18 abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
19 drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
20 and was not originally marketed under a new drug application; or (iv) identified by the health
21 benefit plan as a generic drug based on available data resources such as Medi-Span.
22 (b) Notwithstanding any general or special law to the contrary, there shall be a drug
23 access program, administered by the executive office of health and human services, for the
24 purpose of enhancing access to targeted high-value medications used to treat certain chronic
25 conditions. To implement the drug access program, the secretary of health and human services,
26 in consultation with the department of public health, the division of insurance, the health policy
27 commission, and the center for health information and analysis, shall identify one generic drug
28 and one brand name drug used to treat each of the following chronic conditions: (i) diabetes; (ii)
29 asthma; and (iii) heart conditions, including, but not limited to, hypertension and coronary artery
30 disease. In determining the one generic drug and one brand name drug used to treat each chronic
31 condition, the secretary shall consider whether the drug is:
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32 (1) of clear benefit and strongly supported by clinical evidence to be cost-effective;
33 (2) likely to reduce hospitalizations or emergency department visits, or reduce future
34 exacerbations of illness progression, or improve quality of life;
35 (3) relatively low cost when compared to the cost of an acute illness or incident prevented
36 or delayed by the use of the service, treatment or drug;
37 (4) at low risk for overutilization, abuse, addiction, diversion or fraud; and
38 (5) widely utilized as a treatment for the chronic condition.
39 (c) The secretary of health and human services shall identify insulin as the drug used to
40 treat diabetes under the drug access program.
41 (d) Every two years, the secretary of health and human services, in consultation with the
42 health policy commission, the center for health information and analysis and the division of
43 insurance, shall evaluate the impact of the drug access program established in this section on
44 drug treatment adherence, incidence of related acute events, premiums and cost-sharing, overall
45 health, long-term health costs, and any other issues that the secretary may deem relevant. The
46 secretary may collaborate with an independent research organization to conduct such evaluation.
47 The secretary shall file a report of its findings with the clerks of the house of representatives and
48 senate, the chairs of the joint committee on public health, the chairs of the joint committee on
49 health care financing and the chairs of house and senate committees on ways and means.
50 (e) The secretary, in consultation with the division of insurance, shall promulgate rules
51 and regulations necessary to implement this section.
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52 SECTION 2. Section 1 of chapter 6D of the General Laws, as appearing in the 2020
53 Official Edition, is hereby amended by inserting after the definition of “Alternative payment
54 methodologies or methods” the following 2 definitions:-
55 “Biosimilar”, a drug that is produced or distributed pursuant to a biologics license
56 application approved under 42 U.S.C. 262(k)(3).
57 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
58 drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
59 application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
60 is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
61 Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
62 application that was approved by the United States Secretary of Health and Human Services
63 under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
64 date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
65 1984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
66 C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
67 under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
68 based on available data resources such as Medi-Span.
69 SECTION 3. Said section 1 of said chapter 6D, as so appearing, is hereby further
70 amended by inserting after the definition of “Disproportionate share hospital” the following
71 definition:-
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72 “Early notice”, advanced notification by a pharmaceutical manufacturing company of a:
73 (i) new drug, device or other development coming to market; or (ii) a price increase, as described
74 in subsection (b) of section 15A.
75 SECTION 4. Said section 1 of said chapter 6D, as so appearing, is hereby further
76 amended by inserting after the definition of “Fiscal year” the following definition:-
77 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
78 abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
79 drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
80 and was not originally marketed under a new drug application; or (iv) identified by the health
81 benefit plan as a generic drug based on available data resources such as Medi-Span.
82 SECTION 5. Said section 1 of said chapter 6D, as so appearing, is hereby further
83 amended by striking out, in line 189, the words “not include excludes ERISA plans” and
84 inserting in place thereof the following words:- include self-insured plans to the extent allowed
85 under the federal Employee Retirement Income Security Act of 1974.
86 SECTION 6. Said section 1 of said chapter 6D, as so appearing, is hereby further
87 amended by inserting after the definition of “Performance penalty” the following 2 definitions:-
88 “Pharmaceutical manufacturing company”, an entity engaged in the: (i) production,
89 preparation, propagation, compounding, conversion or processing of prescription drugs, directly
90 or indirectly, by extraction from substances of natural origin, independently by means of
91 chemical synthesis or by a combination of extraction and chemical synthesis; or (ii) packaging,
92 repackaging, labeling, relabeling or distribution of prescription drugs; provided, however, that
93 “pharmaceutical manufacturing company” shall not include a wholesale drug distributor licensed
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 94 under section 36B of chapter 112 or a retail pharmacist registered under section 39 of said
95 chapter 112.
96 “Pharmacy benefit manager”, a person, business or other entity, however organized, that
97 directly or through a subsidiary provides pharmacy benefit management services for prescription
98 drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self-
99 insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit
100 management services shall include, but not be limited to: (i) the processing and payment of
101 claims for prescription drugs; (ii) the performance of drug utilization review; (iii) the processing
102 of drug prior authorization requests; (iv) pharmacy contracting; (v) the adjudication of appeals or
103 grievances related to prescription drug coverage contracts; (vi) formulary administration; (vii)
104 drug benefit design; (viii) mail and specialty drug pharmacy services; (ix) cost containment; (x)
105 clinical, safety and adherence programs for pharmacy services; and (xi) managing the cost of
106 covered prescription drugs; provided further, that “pharmacy benefit manager” shall include a
107 health benefit plan that does not contract with a pharmacy benefit manager and manages its own
108 prescription drug benefits unless specifically exempted by the commission.
109 SECTION 7. Said section 1 of said chapter 6D, as so appearing, is hereby further
110 amended by inserting after the definition of “Physician” the following definition:-
111 “Pipeline drug”, a prescription drug product containing a new molecular entity for which
112 the sponsor has submitted a new drug application or biologics license application and received an
113 action date from the United States Food and Drug Administration.
114 SECTION 8. Said section 1 of said chapter 6D, as so appearing, is hereby further
115 amended by adding the following definition:-
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116 “Wholesale acquisition cost”, shall have the same meaning as defined in 42 U.S.C.
117 1395w-3a(c)(6)(B).
118 SECTION 9. Said chapter 6D is hereby further amended by striking out section 2A, as so
119 appearing, and inserting in place thereof the following section:-
120 Section 2A. The commission shall keep confidential all nonpublic clinical, financial,
121 strategic or operational documents or information provided or reported to the commission in
122 connection with any care delivery, quality improvement process, performance improvement
123 plan, early notification or access and affordability improvement plan activities authorized under
124 sections 7, 10, 14, 15, 15A, 20 or 21 of this chapter or under section 2GGGG of chapter 29 and
125 shall not disclose the information or documents to any person without the consent of the payer,
126 provider or pharmaceutical manufacturing company providing or reporting the information or
127 documents under said sections 7, 10, 14, 15, 15A, 20 or 21 of this chapter or under said section
128 2GGGG of said chapter 29, except in summary form in evaluative reports of such activities or
129 when the commission believes that such disclosure should be made in the public interest after
130 taking into account any privacy, trade secret or anticompetitive considerations. The confidential
131 information and documents shall not be public records and shall be exempt from disclosure
132 under clause Twenty-sixth of section 7 of chapter 4 or under chapter 66.
133 SECTION 10. Section 4 of said chapter 6D, as so appearing, is hereby amended by
134 striking out, in lines 7 and 8, the word “manufacturers” and inserting in place thereof the
135 following words:- manufacturing companies, pharmacy benefit managers,.
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136 SECTION 11. Section 6 of said chapter 6D, as so appearing, is hereby amended by
137 inserting after the word “center”, in line 1, the following words:- , pharmaceutical and
138 biopharmaceutical manufacturing company, pharmacy benefit manager.
139 SECTION 12. Said section 6 of said chapter 6D, as so appearing, is hereby further
140 amended by striking out, in lines 5 and 36, the figure “33” and inserting in place thereof, in each
141 instance, the following figure:- 25.
142 SECTION 13. Said section 6 of said chapter 6D, as so appearing, is hereby further
143 amended by adding the following paragraph:-
144 The assessed amount for pharmaceutical and biopharmaceutical manufacturing
145 companies and pharmacy benefit managers shall be not less than 25 per cent of the amount
146 appropriated by the general court for the expenses of the commission minus amounts collected
147 from: (i) filing fees; (ii) fees and charges generated by the commission's publication or
148 dissemination of reports and information; and (iii) federal matching revenues received for these
149 expenses or received retroactively for expenses of predecessor agencies. Pharmaceutical and
150 biopharmaceutical manufacturing companies and pharmacy benefit managers shall, in a manner
151 and distribution determined by the commission, pay to the commonwealth an amount of the
152 estimated expenses of the commission attributable to the commission’s activities under sections
153 8, 9, 15A, 20 and 21. A pharmacy benefit manager that is a surcharge payor subject to the
154 preceding paragraph and manages its own prescription drug benefits shall not be subject to
155 additional assessment under this paragraph
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156 SECTION 14. Section 8 of said chapter 6D, as so appearing, is hereby amended by
157 inserting after the word “organization”, in lines 6 and 7, the following words:- , pharmacy benefit
158 manager, pharmaceutical manufacturing company.
159 SECTION 15. Said section 8 of said chapter 6D, as so appearing, is hereby further
160 amended by inserting after the wor