Old | New | Differences | |
---|---|---|---|
1 | 1 | ||
2 | 2 | ||
3 | 3 | EXPLANATION: CAPITALS INDICATE MATTER ADDE D TO EXISTING LAW . | |
4 | 4 | [Brackets] indicate matter deleted from existing law. | |
5 | 5 | Underlining indicates amendments to bill. | |
6 | 6 | Strike out indicates matter stricken from the bill by amendment or deleted from the law by | |
7 | 7 | amendment. | |
8 | - | Italics indicate opposite chamber/conference committee amendments. | |
9 | 8 | *hb0970* | |
10 | 9 | ||
11 | 10 | HOUSE BILL 970 | |
12 | - | J5, J4 (5lr2851) | |
13 | - | ENROLLED BILL | |
14 | - | — Health and Government Operations/Finance — | |
15 | - | Introduced by Delegates Woods, Alston, Bagnall, Bhandari, Chisholm, Davis, | |
16 | - | Fisher, Ghrist, Guzzone, Harris, Harrison, Kaufman, Kerr, J. Long, Lopez, | |
17 | - | Martinez, McCaskill, M. Morgan, Patterson, Roberts, Rosenberg, Schmidt, | |
18 | - | Simmons, Szeliga, Taveras, Taylor, Terrasa, and Wilkins Wilkins, Cullison, | |
19 | - | Hill, Hutchinson, S. Johnson, Kaiser, Kipke, Pena –Melnyk, Reilly, Ross, | |
11 | + | J5, J4 5lr2851 | |
12 | + | CF SB 646 | |
13 | + | By: Delegates Woods, Alston, Bagnall, Bhandari, Chisholm, Davis, Fisher, Ghrist, | |
14 | + | Guzzone, Harris, Harrison, Kaufman, Kerr, J. Long, Lopez, Martinez, | |
15 | + | McCaskill, M. Morgan, Patterson, Roberts, Rosenberg, Schmidt, Simmons, | |
16 | + | Szeliga, Taveras, Taylor, Terrasa, and Wilkins Wilkins, Cullison, Hill, | |
17 | + | Hutchinson, S. Johnson, Kaiser, Kipke, Pena –Melnyk, Reilly, Ross, | |
20 | 18 | White Holland, and Woorman | |
21 | - | ||
22 | - | Read and Examined by Proofreaders: | |
23 | - | ||
24 | - | _______________________________________________ | |
25 | - | Proofreader. | |
26 | - | _______________________________________________ | |
27 | - | Proofreader. | |
28 | - | ||
29 | - | Sealed with the Great Seal and presented to the Governor, for his approval this | |
30 | - | ||
31 | - | _______ day of _______________ at ________________________ o’clock, ________M. | |
32 | - | ||
33 | - | ______________________________________________ | |
34 | - | Speaker. | |
19 | + | Introduced and read first time: January 31, 2025 | |
20 | + | Assigned to: Health and Government Operations | |
21 | + | Committee Report: Favorable with amendments | |
22 | + | House action: Adopted | |
23 | + | Read second time: February 27, 2025 | |
35 | 24 | ||
36 | 25 | CHAPTER ______ | |
37 | 26 | ||
38 | 27 | AN ACT concerning 1 | |
39 | 28 | ||
40 | 29 | Health Insurance – Insulin – Prohibition on Step Therapy or Fail–First 2 | |
41 | 30 | Protocols 3 | |
42 | 31 | ||
43 | 32 | FOR the purpose of prohibiting certain insurers, nonprofit health service plans, and health 4 | |
44 | 33 | maintenance organizations from imposing a step therapy or fail–first protocol on 5 | |
45 | - | insulin or an insulin analog or certain other similar medications used to treat an 6 | |
46 | - | insured’s or enrollee’s diabetes; and generally relating to use of step therapy and 7 | |
47 | - | fail–first protocols. 8 | |
34 | + | insulin or certain other similar medications used to treat an insured’s or enrollee’s 6 | |
35 | + | diabetes; and generally relating to use of step therapy and fail–first protocols. 7 | |
48 | 36 | ||
49 | - | BY repealing and reenacting, without amendments, 9 2 HOUSE BILL 970 | |
37 | + | BY repealing and reenacting, without amendments, 8 | |
38 | + | Article – Insurance 9 | |
39 | + | Section 15–142(a)(1) and (4) and (b) 10 | |
40 | + | Annotated Code of Maryland 11 | |
41 | + | (2017 Replacement Volume and 2024 Supplement) 12 | |
42 | + | ||
43 | + | BY repealing and reenacting, with amendments, 13 | |
44 | + | Article – Insurance 14 | |
45 | + | Section 15–142(e) 15 | |
46 | + | Annotated Code of Maryland 16 | |
47 | + | (2017 Replacement Volume and 2024 Supplement) 17 | |
48 | + | 2 HOUSE BILL 970 | |
50 | 49 | ||
51 | 50 | ||
52 | - | Article – Insurance 1 | |
53 | - | Section 15–142(a)(1) and (4) and (b) 2 | |
54 | - | Annotated Code of Maryland 3 | |
55 | - | (2017 Replacement Volume and 2024 Supplement) 4 | |
51 | + | SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 1 | |
52 | + | That the Laws of Maryland read as follows: 2 | |
56 | 53 | ||
57 | - | BY repealing and reenacting, with amendments, 5 | |
58 | - | Article – Insurance 6 | |
59 | - | Section 15–142(e) 7 | |
60 | - | Annotated Code of Maryland 8 | |
61 | - | (2017 Replacement Volume and 2024 Supplement) 9 | |
54 | + | Article – Insurance 3 | |
62 | 55 | ||
63 | - | SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 10 | |
64 | - | That the Laws of Maryland read as follows: 11 | |
56 | + | 15–142. 4 | |
65 | 57 | ||
66 | - | ||
58 | + | (a) (1) In this section the following words have the meanings indicated. 5 | |
67 | 59 | ||
68 | - | 15–142. 13 | |
60 | + | (4) (i) “Step therapy or fail–first protocol” means a protocol established 6 | |
61 | + | by an insurer, a nonprofit health service plan, or a health maintenance organization that 7 | |
62 | + | requires a prescription drug or sequence of prescription drugs to be used by an insured or 8 | |
63 | + | an enrollee before a prescription drug ordered by a prescriber for the insured or the enrollee 9 | |
64 | + | is covered. 10 | |
69 | 65 | ||
70 | - | (a) (1) In this section the following words have the meanings indicated. 14 | |
66 | + | (ii) “Step therapy or fail–first protocol” includes a protocol that 11 | |
67 | + | meets the definition under subparagraph (i) of this paragraph regardless of the name, label, 12 | |
68 | + | or terminology used by the insurer, nonprofit health service plan, or health maintenance 13 | |
69 | + | organization to identify the protocol. 14 | |
71 | 70 | ||
72 | - | (4) (i) “Step therapy or fail–first protocol” means a protocol established 15 | |
73 | - | by an insurer, a nonprofit health service plan, or a health maintenance organization that 16 | |
74 | - | requires a prescription drug or sequence of prescription drugs to be used by an insured or 17 | |
75 | - | an enrollee before a prescription drug ordered by a prescriber for the insured or the enrollee 18 | |
76 | - | is covered. 19 | |
71 | + | (b) (1) This section applies to: 15 | |
77 | 72 | ||
78 | - | (ii) “Step therapy or fail–first protocol” includes a protocol that 20 | |
79 | - | meets the definition under subparagraph (i) of this paragraph regardless of the name, label, 21 | |
80 | - | or terminology used by the insurer, nonprofit health service plan, or health maintenance 22 | |
81 | - | organization to identify the protocol. 23 | |
73 | + | (i) insurers and nonprofit health service plans that provide hospital, 16 | |
74 | + | medical, or surgical benefits to individuals or groups on an expense–incurred basis under 17 | |
75 | + | health insurance policies or contracts that are issued or delivered in the State; and 18 | |
82 | 76 | ||
83 | - | (b) (1) This section applies to: 24 | |
77 | + | (ii) health maintenance organizations that provide hospital, 19 | |
78 | + | medical, or surgical benefits to individuals or groups under contracts that are issued or 20 | |
79 | + | delivered in the State. 21 | |
84 | 80 | ||
85 | - | ( | |
86 | - | ||
87 | - | ||
81 | + | (2) An insurer, a nonprofit health service plan, or a health maintenance 22 | |
82 | + | organization that provides coverage for prescription drugs through a pharmacy benefits 23 | |
83 | + | manager is subject to the requirements of this section. 24 | |
88 | 84 | ||
89 | - | ( | |
90 | - | ||
91 | - | ||
85 | + | (e) An entity subject to this section may not impose a step therapy or fail–first 25 | |
86 | + | protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and 26 | |
87 | + | Drug Administration if: 27 | |
92 | 88 | ||
93 | - | (2) An insurer, a nonprofit health service plan, or a health maintenance 31 | |
94 | - | organization that provides coverage for prescription drugs through a pharmacy benefits 32 | |
95 | - | manager is subject to the requirements of this section. 33 | |
96 | - | HOUSE BILL 970 3 | |
89 | + | (1) (I) the prescription drug is used to treat the insured’s or enrollee’s 28 | |
90 | + | stage four advanced metastatic cancer; and 29 | |
91 | + | ||
92 | + | [(2)] (II) use of the prescription drug is: 30 | |
93 | + | ||
94 | + | [(i)] 1. consistent with the U.S. Food and Drug 31 | |
95 | + | Administration–approved indication or the National Comprehensive Cancer Network 32 | |
96 | + | Drugs & Biologics Compendium indication for the treatment of stage four advanced 33 | |
97 | + | metastatic cancer; and 34 HOUSE BILL 970 3 | |
97 | 98 | ||
98 | 99 | ||
99 | - | (e) An entity subject to this section may not impose a step therapy or fail–first 1 | |
100 | - | protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and 2 | |
101 | - | Drug Administration if: 3 | |
102 | 100 | ||
103 | - | (1) (I) the prescription drug is used to treat the insured’s or enrollee’s 4 | |
104 | - | stage four advanced metastatic cancer; and 5 | |
101 | + | [(ii)] 2. supported by peer–reviewed medical literature; OR 1 | |
105 | 102 | ||
106 | - | | |
103 | + | (2) THE PRESCRIPTION DRU G IS: 2 | |
107 | 104 | ||
108 | - | [(i)] 1. consistent with the U.S. Food and Drug 7 | |
109 | - | Administration–approved indication or the National Comprehensive Cancer Network 8 | |
110 | - | Drugs & Biologics Compendium indication for the treatment of stage four advanced 9 | |
111 | - | metastatic cancer; and 10 | |
105 | + | (I) INSULIN USED TO TREAT THE IN SURED’S OR ENROLLEE ’S 3 | |
106 | + | TYPE 1, TYPE 2, OR GESTATIONAL DIABE TES; AND 4 | |
112 | 107 | ||
113 | - | | |
108 | + | (II) 1. INSULIN; OR 5 | |
114 | 109 | ||
115 | - | (2) THE PRESCRIPTION DRUG IS: 12 | |
110 | + | 2. AN INSULIN ANALOG OR OTHER PRESCRIPTION D RUG 6 | |
111 | + | THAT PERFORMS A SIMI LAR FUNCTION TO INSU LIN, REGARDLESS OF THE 7 | |
112 | + | ACTIVATION PERIOD , WHETHER THE SOLUTION IS MIXED BEFORE OR A FTER 8 | |
113 | + | DISPENSING, OR WHETHER THE DRUG IS ADMINISTERED BY I NJECTION OR 9 | |
114 | + | INHALATION. 10 | |
116 | 115 | ||
117 | - | (I) INSULIN OR AN INSULIN ANALOG USED TO TREAT THE 13 | |
118 | - | INSURED’S OR ENROLLEE ’S TYPE 1, TYPE 2, OR GESTATIONAL DIABE TES; AND 14 | |
116 | + | SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 11 | |
117 | + | policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 12 | |
118 | + | after January 1, 2026. 13 | |
119 | 119 | ||
120 | - | (II) 1. INSULIN; OR 15 | |
120 | + | SECTION 3. AND BE IT FURTHER ENACTED, That this A ct shall take effect 14 | |
121 | + | January 1, 2026. 15 | |
121 | 122 | ||
122 | - | 2. AN INSULIN ANALOG OR OTHER PRESCRIPTION D RUG 16 | |
123 | - | THAT PERFORMS A SIMI LAR FUNCTION TO INSULIN , REGARDLESS OF THE 17 | |
124 | - | ACTIVATION PERIOD , WHETHER THE SOLUTION IS MIXED BEFORE OR A FTER 18 | |
125 | - | DISPENSING, OR WHETHER THE DRUG IS ADMINISTERED BY I NJECTION OR 19 | |
126 | - | INHALATION. 20 | |
127 | 123 | ||
128 | - | SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 21 | |
129 | - | policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 22 | |
130 | - | after January 1, 2026. 23 | |
131 | 124 | ||
132 | - | SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect 24 | |
133 | - | January 1, 2026. 25 | |
125 | + | ||
126 | + | Approved: | |
127 | + | ________________________________________________________________________________ | |
128 | + | Governor. | |
129 | + | ________________________________________________________________________________ | |
130 | + | Speaker of the House of Delegates. | |
131 | + | ________________________________________________________________________________ | |
132 | + | President of the Senate. |