Massachusetts 2023-2024 Regular Session

Massachusetts House Bill H1969 Compare Versions

Only one version of the bill is available at this time.

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2	2	HOUSE DOCKET, NO. 1692 FILED ON: 1/18/2023
3	3	HOUSE . . . . . . . . . . . . . . . No. 1969
4	4	The Commonwealth of Massachusetts
5	5	_________________
6	6	PRESENTED BY:
7	7	Simon Cataldo and Kate Donaghue
8	8	_________________
9	9	To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
10	10	Court assembled:
11	11	The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
12	12	An Act relative to the establishment of and payments into an opioid stewardship fund.
13	13	_______________
14	14	PETITION OF:
15	15	NAME:DISTRICT/ADDRESS :DATE ADDED:Simon Cataldo14th Middlesex1/18/2023Kate Donaghue19th Worcester1/19/2023Margaret R. Scarsdale1st Middlesex2/13/2023 1 of 7
16	16	HOUSE DOCKET, NO. 1692 FILED ON: 1/18/2023
17	17	HOUSE . . . . . . . . . . . . . . . No. 1969
18	18	By Representatives Cataldo of Concord and Donaghue of Westborough, a petition (accompanied
19	19	by bill, House, No. 1969) of Simon Cataldo, Kate Donaghue and Margaret R. Scarsdale relative
20	20	to the establishment of and payments into an opioid stewardship fund. Mental Health, Substance
21	21	Use and Recovery.
22	22	The Commonwealth of Massachusetts
23	23	_______________
24	24	In the One Hundred and Ninety-Third General Court
25	25	(2023-2024)
26	26	_______________
27	27	An Act relative to the establishment of and payments into an opioid stewardship fund.
28	28	Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
29	29	of the same, as follows:
30	30	1 SECTION 1. Over the past few years across the state we have become all too aware of
31	31	2the prevalence of opioid use disorders. Despite increased public awareness and prevention
32	32	3efforts, all of our communities have been impacted by the ongoing opioid epidemic.
33	33	4 Law enforcement and first responders have had much success reviving people who have
34	34	5overdosed with the use of nasal naloxone. Naloxone has been credited as a significant factor in
35	35	6the decrease in the number of fatal overdoses in the last year in the Commonwealth.
36	36	7 Recognizing the impact that access to this drug has on saving lives, now people across
37	37	8the state can go to a pharmacy and get naloxone. Having access is not enough, however, if-- even
38	38	9with insurance--the cost of the co-pay is prohibitive. 2 of 7
39	39	10 Every overdose death is the loss of someone’s child, someone’s parent, someone’s
40	40	11brother or sister, someone’s friend; and it need not happen. We must work to get naloxone into
41	41	12the hands of everyone who needs it.
42	42	13 SECTION 2: Chapter 94C of the General Laws, as appearing in the 2016 Official
43	43	14Edition, is hereby amended by adding the following new section 50:
44	44	15 (a) Naloxone Co-Pay Assistance Program.
45	45	16 The department of public health shall establish and promulgate regulations for
46	46	17administration of a Naloxone Co-Pay Assistance Program, a program to improve access to those
47	47	18who seek to obtain naloxone and other medications approved by the United States Food and
48	48	19Drug Administration that, when administered, negates or neutralizes in whole or in part the
49	49	20pharmacological effects of an opioid in the body. The program shall supplement the cost of
50	50	21insurance copayments so that the cost of Naloxone is greatly reduced or free of charge to those
51	51	22who need it.
52	52	23 (b)(1) There shall be established in the Commonwealth a separate trust fund to be known
53	53	24as the Opioid Stewardship Fund to support the Naloxone Co-Pay Assistance Program established
54	54	25in subsection 50(a).
55	55	26 (b)(2) Monies in the Opioid Stewardship Fund shall be kept separate and shall not be
56	56	27commingled with any other monies in the custody of the State Comptroller and the
57	57	28Commissioner of Administration and Finance. The fund shall be maintained by the
58	58	29Commissioner of Public Health or a designee. The monies shall be expended under the direction
59	59	30of the department of public health, without prior appropriation. Any balance in the fund at the
60	60	31close of a fiscal year shall be available for expenditure in subsequent fiscal years and shall not be 3 of 7
61	61	32transferred to any other fund or revert to the General Fund. The Commissioner of Public Health
62	62	33or a designee shall annually report the amount of funds collected and any expenditures made
63	63	34from the fund to the clerks of the house of representatives and senate to be forwarded on to the
64	64	35house and senate committees on ways and means, the house and senate chairs of the joint
65	65	36committee on public health and the house and senate chairs of the joint committee on health care
66	66	37financing.
67	67	38 (b)(3) The Opioid Stewardship Fund shall consist of the opioid stewardship payments
68	68	39made by each manufacturer and distributor as directed in subsection 50(c)(3), monies
69	69	40appropriated for the purpose of such fund, and monies transferred to such fund pursuant to law.
70	70	41 (c)(1) Definitions:
71	71	42 (i) "Opioid stewardship payment" shall mean the total amount to be paid into the Opioid
72	72	43Stewardship Fund for each state fiscal year as set forth in subsection (d)(4);
73	73	44 (ii) "Ratable share" shall mean the individual portion of the opioid stewardship payment
74	74	45to be paid by each manufacturer and distributor registered with the Commissioner of Public
75	75	46Health pursuant to section 7(a) of this chapter or registered with the board of registration in
76	76	47pharmacy pursuant to section 12(a) of this chapter (hereinafter "registrants") that sells or
77	77	48distributes or delivers opioids in the Commonwealth;
78	78	49 (c)(2) Reports and records of Registrants. Annually each registrant shall provide to the
79	79	50Commissioner of Public Health a report detailing all opioids sold or distributed by such
80	80	51manufacturer or distributor in the Commonwealth. Such information shall be reported to the
81	81	52department of public health in such form as designed by the Commissioner, provided however
82	82	53that the initial report provided upon the establishment of the Opioid Stewardship Fund shall 4 of 7
83	83	54report all opioids sold or distributed by the registrant in the Commonwealth for the 2019
84	84	55calendar year, and must be submitted by August 1, 2020. Subsequent annual reports shall be
85	85	56submitted on April first of each year based on the actual opioid sales and distributions of the
86	86	57prior calendar year.
87	87	58 Such report shall include:
88	88	59 (i) the manufacturer's or distributor's name, address, phone number, federal Drug
89	89	60Enforcement Agency (DEA) registration number and controlled substance registration number
90	90	61issued by the department of public health or board of registration in pharmacy;
91	91	62 (ii) the name, address and DEA registration number of the entity to whom the opioid was
92	92	63sold or distributed;
93	93	64 (iii) the date of the sale or distribution of the opioid;
94	94	65 (iv) the gross receipt total, in dollars, of all opioids sold or distributed;
95	95	66 (v) the name and National Drug Code (NDC) of the opioid sold or distributed;
96	96	67 (vi) the number of containers and the strength and metric quantity of controlled substance
97	97	68in each container of the opioid sold or distributed;
98	98	69 (vii) the total number of morphine milligram equivalents (MMEs) sold or distributed; and
99	99	70 (viii) any other elements as deemed necessary by the commissioner.
100	100	71 For the purpose of such annual reporting, MMEs shall be determined pursuant to a
101	101	72formulation to be issued by the department of public health and updated as the department deems
102	102	73appropriate. 5 of 7
103	103	74 (c)(3) Determination of ratable share. Each registered manufacturer and distributor that
104	104	75sells or distributes opioids in the Commonwealth shall pay a portion of the total opioid
105	105	76stewardship payment amount. The department shall notify the registrant in writing annually on or
106	106	77before October fifteenth of each year of the registrant’s ratable share, based on the report of
107	107	78opioids sold or distributed for the prior calendar year. The ratable share shall be calculated as
108	108	79follows:
109	109	80 (i) The total amount of MMEs sold or distributed in the Commonwealth by the registrant
110	110	81for the preceding calendar year, as reported by the registrant pursuant to subsection (c)(2), shall
111	111	82be divided by the total amount of MME sold or distributed in the Commonwealth by all
112	112	83registrants to determine the registrant payment percentage. The registrant payment percentage
113	113	84shall be multiplied by the total opioid stewardship payment. The product of such calculations
114	114	85shall be the registrant's ratable share. The department of public health shall have the authority to
115	115	86adjust the total number of a registrant's MMEs to account for the nature and use of the product,
116	116	87as well as the type of entity purchasing the product from the registrant, when making such
117	117	88determination and adjust the ratable share accordingly.
118	118	89 (ii) The registrant’s total amount of MME sold or distributed, as well as the total amount
119	119	90of MME sold or distributed by all registrants under this chapter, used in the calculation of the
120	120	91ratable share shall not include the MME of those opioids which are: (a) manufactured in the
121	121	92Commonwealth, but whose final point of delivery or sale is outside of the Commonwealth; (b)
122	122	93sold or distributed to entities certified to operate pursuant to section 5 of chapter 111E, or section
123	123	9457D of chapter 111; or (c) the MMEs attributable to buprenorphine, methadone or morphine. 6 of 7
124	124	95 (c)(4) Opioid stewardship payment imposed on manufacturers and distributors. All
125	125	96registered manufacturers and distributors that sell or distribute opioids in the Commonwealth
126	126	97shall be required to pay an opioid stewardship payment. On an annual basis, the Commissioner
127	127	98of Public Health shall certify to the State Comptroller the amount of all revenues collected from
128	128	99opioid stewardship payments and any penalties imposed. The amount of revenues so certified
129	129	100shall be deposited quarterly into the opioid stewardship fund established pursuant to subsection
130	130	10150(b).
131	131	102 (c)(5). Payment of ratable share. The registrant shall make payments of the ratable share
132	132	103quarterly to the department of public health with the first quarter’s due on January 1 following
133	133	104the annual notice as set forth in subsection (d)(3); additional quarterly payments shall be due and
134	134	105owing on the first day of every quarter thereafter.
135	135	106 (c)(6). Rebate of ratable share. In any year for which the Commissioner of Public Health
136	136	107determines that any registrant has failed to make a timely report of required information pursuant
137	137	108to subsection (c)(2), then those registrants who comply by making a timely report pursuant to
138	138	109subsection (c)(2) shall receive a reduced assessment of their ratable share in the following year
139	139	110equal to the amount in excess of any overpayment in the prior year’s payment.
140	140	111 (c)(7). Registrant’s opportunity to appeal. A registrant shall be afforded an opportunity to
141	141	112submit information to the department of public health to justify why the ratable share calculated
142	142	113for the registrant pursuant to subsection (c)(3), or amounts paid thereunder, are in error or
143	143	114otherwise not warranted. If the department determines thereafter that all or a portion of such
144	144	115ratable share, as determined by the Commissioner pursuant to subsection (c)(3), is not warranted,
145	145	116the department may: (a) adjust the ratable share; (b) adjust the assessment of the ratable share in 7 of 7
146	146	117the following year equal to the amount in excess of any overpayment in the prior payment
147	147	118period; or (c) refund amounts paid in error.
148	148	119 (c)(8) Penalties.
149	149	120 (i) The department may assess a civil penalty in an amount not to exceed one thousand
150	150	121dollars per day against any registrant that fails to comply with subsections (d)(2) or (d)(5).
151	151	122 (ii) In addition to any other civil or criminal penalty provided by law, where a registrant
152	152	123has failed to pay its ratable share in accordance with subsection (d)(5), the department may also
153	153	124assess a penalty of no less than ten percent and no greater than three hundred percent of the
154	154	125ratable share due from such registrant.