1 | 1 | | |
---|
2 | 2 | | |
---|
3 | 3 | | |
---|
4 | 4 | | |
---|
5 | 5 | | 2025 -- H 5860 |
---|
6 | 6 | | ======== |
---|
7 | 7 | | LC002090 |
---|
8 | 8 | | ======== |
---|
9 | 9 | | S T A T E O F R H O D E I S L A N D |
---|
10 | 10 | | IN GENERAL ASSEMBLY |
---|
11 | 11 | | JANUARY SESSION, A.D. 2025 |
---|
12 | 12 | | ____________ |
---|
13 | 13 | | |
---|
14 | 14 | | A N A C T |
---|
15 | 15 | | RELATING TO FOOD AND DRUGS -- PRESCRIPTION DRUG COST PROTECTION |
---|
16 | 16 | | Introduced By: Representatives Tanzi, Kislak, Hull, Morales, Potter, Ajello, Bennett, |
---|
17 | 17 | | Cortvriend, Boylan, and Cotter |
---|
18 | 18 | | Date Introduced: February 28, 2025 |
---|
19 | 19 | | Referred To: House Health & Human Services |
---|
20 | 20 | | |
---|
21 | 21 | | |
---|
22 | 22 | | It is enacted by the General Assembly as follows: |
---|
23 | 23 | | SECTION 1. Legislative intent. 1 |
---|
24 | 24 | | The purpose of this chapter is to protect the safety, health, and economic well-being of 2 |
---|
25 | 25 | | Rhode Island residents by safeguarding them from the negative and harmful impact of excessive 3 |
---|
26 | 26 | | and unconscionable prices for prescription drugs. In enacting this act, the legislature finds that 4 |
---|
27 | 27 | | access to prescription drugs is necessary for Rhode Island residents to maintain or achieve good 5 |
---|
28 | 28 | | health: 6 |
---|
29 | 29 | | (i) Excessive prices negatively impact the ability of Rhode Island residents to obtain 7 |
---|
30 | 30 | | prescription drugs and price increases that exceed reasonable levels thereby endanger the health 8 |
---|
31 | 31 | | and safety of Rhode Island residents to maintain or achieve good health; 9 |
---|
32 | 32 | | (ii) Excessive prices for prescription drugs threaten the economic well-being of Rhode 10 |
---|
33 | 33 | | Island residents and endanger their ability to pay for other necessary and essential goods and 11 |
---|
34 | 34 | | services including housing, food and utilities; 12 |
---|
35 | 35 | | (iii) Excessive prices for prescription drugs contribute significantly to a dramatic and 13 |
---|
36 | 36 | | unsustainable rise in health care costs and health insurance that threaten the overall ability of Rhode 14 |
---|
37 | 37 | | Island residents to obtain health coverage and maintain or achieve good health; 15 |
---|
38 | 38 | | (iv) Excessive prices for prescription drugs contribute significantly to rising state costs for 16 |
---|
39 | 39 | | health care provided and paid for through health insurance programs for public employees, 17 |
---|
40 | 40 | | including employees of the state, municipalities and counties, school districts, institutions of higher 18 |
---|
41 | 41 | | education, and retirees whose health care costs are funded by public programs, thereby threatening 19 |
---|
42 | 42 | | |
---|
43 | 43 | | |
---|
44 | 44 | | LC002090 - Page 2 of 6 |
---|
45 | 45 | | the ability of the state to fund those programs adequately and further threatening the ability of the 1 |
---|
46 | 46 | | state to fund other programs necessary for the public good and safety, such as public education and 2 |
---|
47 | 47 | | public safety; and 3 |
---|
48 | 48 | | (v) Based on findings in subsections (i) through (iv) of this section, the legislature finds 4 |
---|
49 | 49 | | that excessive prices for prescription drugs threaten the safety and well-being of Rhode Island 5 |
---|
50 | 50 | | residents and find it is necessary to act in order to protect Rhode Island residents from the negative 6 |
---|
51 | 51 | | impact of excessive costs. 7 |
---|
52 | 52 | | SECTION 2. Title 21 of the General Laws entitled "FOOD AND DRUGS" is hereby 8 |
---|
53 | 53 | | amended by adding thereto the following chapter: 9 |
---|
54 | 54 | | CHAPTER 38 10 |
---|
55 | 55 | | PRESCRIPTION DRUG COST PROTECTION 11 |
---|
56 | 56 | | 21-38-1. Definitions. 12 |
---|
57 | 57 | | As used in this chapter: 13 |
---|
58 | 58 | | (1) “ERISA Plan” means a plan qualified under the Employee Retirement Income Security 14 |
---|
59 | 59 | | Act of 1974, 29 U.S.C. ch. 18 § 1001 et seq. 15 |
---|
60 | 60 | | (2) “Health plan” means any entity subject to the insurance laws and regulations of this 16 |
---|
61 | 61 | | state, or subject to the jurisdiction of the commissioner, that contracts or offers to contract to 17 |
---|
62 | 62 | | provide, deliver, arrange for, pay for, or reimburse any of the costs of healthcare services including, 18 |
---|
63 | 63 | | without limitation, an insurance company offering accident and sickness insurance, a health 19 |
---|
64 | 64 | | maintenance organization licensed under chapter 41 of title 27, a nonprofit hospital service 20 |
---|
65 | 65 | | corporation organized under chapter 19 of title 27, a nonprofit medical service corporation 21 |
---|
66 | 66 | | organized under chapter 20 of title 27, a nonprofit dental service corporation organized under 22 |
---|
67 | 67 | | chapter 20.1 of title 27, a nonprofit optometric service corporation organized under chapter 20.2 of 23 |
---|
68 | 68 | | title 27, a domestic insurance company subject to chapter 1 of title 27 that offers or provides health 24 |
---|
69 | 69 | | insurance coverage in the state, and a foreign insurance company subject to chapter 2 of title 27 25 |
---|
70 | 70 | | that offers or providers health insurance coverage in the state. 26 |
---|
71 | 71 | | (3) "Insurance commissioner" or "commissioner" means the director of the department of 27 |
---|
72 | 72 | | business regulation or the director's designee. 28 |
---|
73 | 73 | | (4) “Maximum fair price” means the maximum rate for a drug published by the Secretary 29 |
---|
74 | 74 | | of the United States Department of Health and Human Services pursuant to Section 1195 of P.L. 30 |
---|
75 | 75 | | 117-169 (2022). 31 |
---|
76 | 76 | | (5) “Participating ERISA plan” means an ERISA plan that has elected to participate in the 32 |
---|
77 | 77 | | requirements and restrictions of this chapter and provides notice as described in § 21-38-3. 33 |
---|
78 | 78 | | (6) “Price applicability period” means the period of time defined in Section 1191 of P.L. 34 |
---|
79 | 79 | | |
---|
80 | 80 | | |
---|
81 | 81 | | LC002090 - Page 3 of 6 |
---|
82 | 82 | | 117-169 (2022). 1 |
---|
83 | 83 | | (7) “Referenced drug” means a drug subject to a maximum fair price. 2 |
---|
84 | 84 | | (8) “State entity” means any agency of state government that purchases prescription drugs 3 |
---|
85 | 85 | | on behalf of the state for a person whose health care is paid for by the state, including any agent, 4 |
---|
86 | 86 | | vendor, fiscal agent, contractor, or other party acting on behalf of the state. State entity does not 5 |
---|
87 | 87 | | include the medical assistance program established under 42 U.S.C. §1396 et seq. 6 |
---|
88 | 88 | | 21-38-2. Payment in excess of referenced rate prohibited. 7 |
---|
89 | 89 | | (a) The maximum fair price is the maximum payment for a referenced drug and applies to 8 |
---|
90 | 90 | | all purchases of a referenced drug and reimbursements for a claim for the referenced drug during 9 |
---|
91 | 91 | | the price applicability period when the referenced drug is dispensed, delivered, or administered to 10 |
---|
92 | 92 | | an individual in the state in person, by mail, or by other means. 11 |
---|
93 | 93 | | (b) It is a violation of this chapter for any purchaser to purchase a referenced drug or seek 12 |
---|
94 | 94 | | reimbursement for a referenced drug to be dispensed, delivered, or administered to an individual in 13 |
---|
95 | 95 | | the state in person, by mail, or by other means for a cost higher than the maximum fair price. The 14 |
---|
96 | 96 | | maximum fair price does not include a dispensing fee paid to a pharmacy for dispensing a 15 |
---|
97 | 97 | | referenced drug and nothing in this chapter shall be interpreted to prevent a retail pharmacy from 16 |
---|
98 | 98 | | receiving a dispensing fee above the maximum fair price. 17 |
---|
99 | 99 | | 21-38-3. ERISA plan opt-in. 18 |
---|
100 | 100 | | An ERISA plan may elect to participate in the provisions of this chapter. Any ERISA plan 19 |
---|
101 | 101 | | that desires its purchase of prescription drugs to be subject to the prohibition described in this 20 |
---|
102 | 102 | | section shall notify the insurance commissioner in writing by February 1 of each year. 21 |
---|
103 | 103 | | 21-38-4. Rulemaking authority. 22 |
---|
104 | 104 | | The insurance commissioner shall have the authority to implement regulations pursuant to 23 |
---|
105 | 105 | | chapter 35 of title 42 ("administrative procedures") to fully implement the requirements of this 24 |
---|
106 | 106 | | chapter. 25 |
---|
107 | 107 | | 21-38-5. Registered agent and office within the state. 26 |
---|
108 | 108 | | Any entity that sells, distributes, delivers, or offers for sale any drug in the state is required 27 |
---|
109 | 109 | | to maintain a registered agent and office within the state. 28 |
---|
110 | 110 | | 21-38-6. Use of savings. 29 |
---|
111 | 111 | | (a) Any savings generated as a result of the requirements in § 21-38-3 during the referenced 30 |
---|
112 | 112 | | rate applicability period above shall be used to reduce costs to consumers. Any state entity, health 31 |
---|
113 | 113 | | plan or participating ERISA plan shall calculate such savings and utilize such savings directly to 32 |
---|
114 | 114 | | reduce costs for its members. In determining how to utilize savings in order to comply with this 33 |
---|
115 | 115 | | provision, purchasers are directed to consider strategies that promote greater health equity by 34 |
---|
116 | 116 | | |
---|
117 | 117 | | |
---|
118 | 118 | | LC002090 - Page 4 of 6 |
---|
119 | 119 | | addressing disparities across communities. 1 |
---|
120 | 120 | | (b) No later than April 1 of each calendar year, each state entity, health plan and 2 |
---|
121 | 121 | | participating ERISA plan subject to this chapter shall submit to the insurance commissioner a report 3 |
---|
122 | 122 | | describing the savings achieved for each referenced drug for the previous calendar year and how 4 |
---|
123 | 123 | | those savings were used to achieve the requirements of subsection (a) of this section, including how 5 |
---|
124 | 124 | | the savings were used to promote greater health equity by addressing disparities across 6 |
---|
125 | 125 | | communities. 7 |
---|
126 | 126 | | (c) The insurance commissioner shall implement rules setting forth the method for 8 |
---|
127 | 127 | | calculating savings and the format and submission requirements for the report described in 9 |
---|
128 | 128 | | subsection (b) of this section. 10 |
---|
129 | 129 | | 21-38-7. Enforcement. 11 |
---|
130 | 130 | | Each violation of this chapter shall be subject to a fine of one thousand dollars ($1,000). 12 |
---|
131 | 131 | | Every individual transaction in violation of § 21-38-2 is determined to be a separate violation. The 13 |
---|
132 | 132 | | attorney general is authorized to enforce the provisions of this statute. The refusal of a manufacturer 14 |
---|
133 | 133 | | or distributor to negotiate in good faith as described in § 21-38-8(d) shall be a valid affirmative 15 |
---|
134 | 134 | | defense in any enforcement action brought under this chapter. 16 |
---|
135 | 135 | | 21-38-8. Prohibition on withdrawal of referenced drugs for sale. 17 |
---|
136 | 136 | | (a) It shall be a violation of this chapter for any manufacturer or distributor of a referenced 18 |
---|
137 | 137 | | drug to withdraw that drug from sale or distribution within this state for the purpose of avoiding 19 |
---|
138 | 138 | | the impact of the rate limitations set forth in § 21-38-3. 20 |
---|
139 | 139 | | (b) Any manufacturer that intends to withdraw a referenced drug from sale or distribution 21 |
---|
140 | 140 | | from within the state shall provide a notice of withdrawal in writing to the insurance commissioner 22 |
---|
141 | 141 | | and to the attorney general one hundred eighty (180) days prior to such withdrawal. 23 |
---|
142 | 142 | | (c) The insurance commissioner shall assess a penalty on any manufacturer or distributor 24 |
---|
143 | 143 | | that it determines has withdrawn a referenced drug from distribution or sale in the state in violation 25 |
---|
144 | 144 | | of subsection (a) or (b) of this section. With respect to each referenced drug for which the insurance 26 |
---|
145 | 145 | | commissioner has determined the manufacturer or distributor has withdrawn from the market, the 27 |
---|
146 | 146 | | penalty shall be equal to: 28 |
---|
147 | 147 | | (1) Five hundred thousand dollars ($500,000); or 29 |
---|
148 | 148 | | (2) The amount of annual savings determined by the insurance commissioner as described 30 |
---|
149 | 149 | | in § 21-38-6, whichever is greater. 31 |
---|
150 | 150 | | (d) It shall be a violation of this chapter for any manufacturer or distributor of a referenced 32 |
---|
151 | 151 | | drug to refuse to negotiate in good faith with any payor or seller of prescription drugs a price that 33 |
---|
152 | 152 | | is within the referenced rate as determined in § 21-38-2. 34 |
---|
153 | 153 | | |
---|
154 | 154 | | |
---|
155 | 155 | | LC002090 - Page 5 of 6 |
---|
156 | 156 | | (e) The insurance commissioner shall assess a penalty on any manufacturer or distributor 1 |
---|
157 | 157 | | that it determines has failed to negotiate in good faith. With respect to each referenced drug for 2 |
---|
158 | 158 | | which the insurance commissioner has determined the manufacturer or distributor has failed to 3 |
---|
159 | 159 | | negotiate in good faith, the penalty shall be equal to: 4 |
---|
160 | 160 | | (1) Five hundred thousand dollars ($500,000); or 5 |
---|
161 | 161 | | (2) The amount of annual savings determined by the insurance commissioner as described 6 |
---|
162 | 162 | | in § 21-38-6, whichever is greater. 7 |
---|
163 | 163 | | 21-38-9. Severability clause. 8 |
---|
164 | 164 | | If any provision of this chapter or the application thereof is determined to be invalid, the 9 |
---|
165 | 165 | | invalidity shall not affect other provisions or applications of this chapter which can be given effect 10 |
---|
166 | 166 | | without the invalid provision or application, and to this end the provisions of this chapter are 11 |
---|
167 | 167 | | severable. 12 |
---|
168 | 168 | | SECTION 3. This act shall take effect upon passage. 13 |
---|
169 | 169 | | ======== |
---|
170 | 170 | | LC002090 |
---|
171 | 171 | | ======== |
---|
172 | 172 | | |
---|
173 | 173 | | |
---|
174 | 174 | | LC002090 - Page 6 of 6 |
---|
175 | 175 | | EXPLANATION |
---|
176 | 176 | | BY THE LEGISLATIVE COUNCIL |
---|
177 | 177 | | OF |
---|
178 | 178 | | A N A C T |
---|
179 | 179 | | RELATING TO FOOD AND DRUGS -- PRESCRIPTION DRUG COST PROTECTION |
---|
180 | 180 | | *** |
---|
181 | 181 | | This act would prohibit the state, participating ERISA, or any health plan from purchasing 1 |
---|
182 | 182 | | referenced drugs for a cost higher than the referenced rate. 2 |
---|
183 | 183 | | This act would take effect upon passage. 3 |
---|
184 | 184 | | ======== |
---|
185 | 185 | | LC002090 |
---|
186 | 186 | | ======== |
---|