Old | New | Differences | |
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1 | 1 | ||
2 | 2 | ||
3 | 3 | EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW. | |
4 | 4 | [Brackets] indicate matter deleted from existing law. | |
5 | - | Underlining indicates amendments to bill. | |
6 | - | Strike out indicates matter stricken from the bill by amendment or deleted from the law by | |
7 | - | amendment. | |
8 | 5 | *hb1243* | |
9 | 6 | ||
10 | 7 | HOUSE BILL 1243 | |
11 | 8 | J5 5lr2645 | |
12 | 9 | CF SB 975 | |
13 | - | By: Delegate S. Johnson Delegates S. Johnson, Alston, Bagnall, Bhandari, | |
14 | - | Chisholm, Cullison, Guzzone, Hill, Hutchinson, Kaiser, Kerr, Kipke, Lopez, | |
15 | - | Martinez, M. Morgan, Pena–Melnyk, Reilly, Rosenberg, Ross, Szeliga, | |
16 | - | Taveras, White Holland, Woods, and Woorman | |
10 | + | By: Delegate S. Johnson | |
17 | 11 | Introduced and read first time: February 7, 2025 | |
18 | 12 | Assigned to: Health and Government Operations | |
19 | - | Committee Report: Favorable with amendments | |
20 | - | House action: Adopted | |
21 | - | Read second time: March 1, 2025 | |
22 | 13 | ||
23 | - | ||
14 | + | A BILL ENTITLED | |
24 | 15 | ||
25 | 16 | AN ACT concerning 1 | |
26 | 17 | ||
27 | 18 | Health Insurance – Coverage for Specialty Drugs 2 | |
28 | 19 | ||
29 | 20 | FOR the purpose of prohibiting certain insurers, nonprofit health service plans, and health 3 | |
30 | 21 | maintenance organizations from excluding coverage for certain specialty drugs that 4 | |
31 | 22 | are administered or dispensed by a provider that meets certain criteria; requiring 5 | |
32 | 23 | the reimbursement rate for certain specialty drugs to meet certain criteria; and 6 | |
33 | 24 | generally relating to health insurance coverage for specialty drugs. 7 | |
34 | 25 | ||
35 | 26 | BY repealing and reenacting, without amendments, 8 | |
36 | 27 | Article – Insurance 9 | |
37 | 28 | Section 15–847(a)(1) and (5) 10 | |
38 | 29 | Annotated Code of Maryland 11 | |
39 | 30 | (2017 Replacement Volume and 2024 Supplement) 12 | |
40 | 31 | ||
41 | 32 | BY repealing and reenacting, with amendments, 13 | |
42 | 33 | Article – Insurance 14 | |
43 | 34 | Section 15–847(d), 15–1611.1, and 15–1612 15 | |
44 | 35 | Annotated Code of Maryland 16 | |
45 | 36 | (2017 Replacement Volume and 2024 Supplement) 17 | |
46 | 37 | ||
47 | 38 | BY adding to 18 | |
48 | - | Article – Insurance 19 2 HOUSE BILL 1243 | |
39 | + | Article – Insurance 19 | |
40 | + | Section 15–847.2 20 | |
41 | + | Annotated Code of Maryland 21 | |
42 | + | (2017 Replacement Volume and 2024 Supplement) 22 | |
43 | + | ||
44 | + | SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 23 | |
45 | + | That the Laws of Maryland read as follows: 24 | |
46 | + | ||
47 | + | Article – Insurance 25 | |
48 | + | 2 HOUSE BILL 1243 | |
49 | 49 | ||
50 | 50 | ||
51 | - | Section 15–847(h) and 15–847.2 1 | |
52 | - | Annotated Code of Maryland 2 | |
53 | - | (2017 Replacement Volume and 2024 Supplement) 3 | |
51 | + | 15–847. 1 | |
54 | 52 | ||
55 | - | SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 4 | |
56 | - | That the Laws of Maryland read as follows: 5 | |
53 | + | (a) (1) In this section the following words have the meanings indicated. 2 | |
57 | 54 | ||
58 | - | ||
55 | + | (5) (i) “Specialty drug” means a prescription drug that: 3 | |
59 | 56 | ||
60 | - | 15–847. 7 | |
57 | + | 1. is prescribed for an individual with a complex or chronic 4 | |
58 | + | medical condition or a rare medical condition; 5 | |
61 | 59 | ||
62 | - | | |
60 | + | 2. costs $600 or more for up to a 30–day supply; 6 | |
63 | 61 | ||
64 | - | | |
62 | + | 3. is not typically stocked at retail pharmacies; and 7 | |
65 | 63 | ||
66 | - | | |
67 | - | ||
64 | + | 4. A. requires a difficult or unusual process of delivery to 8 | |
65 | + | the patient in the preparation, handling, storage, inventory, or distribution of the drug; or 9 | |
68 | 66 | ||
69 | - | 2. costs $600 or more for up to a 30–day supply; 12 | |
67 | + | B. requires enhanced patient education, management, or 10 | |
68 | + | support, beyond those required for traditional dispensing, before or after administration of 11 | |
69 | + | the drug. 12 | |
70 | 70 | ||
71 | - | 3. is not typically stocked at retail pharmacies; and 13 | |
71 | + | (ii) “Specialty drug” does not include a prescription drug prescribed 13 | |
72 | + | to treat diabetes, HIV, or AIDS. 14 | |
72 | 73 | ||
73 | - | 4. A. requires a difficult or unusual process of delivery to 14 | |
74 | - | the patient in the preparation, handling, storage, inventory, or distribution of the drug; or 15 | |
74 | + | (d) Subject to § 15–805 of this subtitle [and], notwithstanding § 15–806 of this 15 | |
75 | + | subtitle, [nothing in] AND EXCEPT AS PROVIDED IN § 15–847.2 OF THIS SUBTITLE, this 16 | |
76 | + | article or regulations adopted under this article [precludes] DO NOT PRECLUDE an entity 17 | |
77 | + | subject to this section from requiring a covered specialty drug to be obtained through: 18 | |
75 | 78 | ||
76 | - | B. requires enhanced patient education, management, or 16 | |
77 | - | support, beyond those required for traditional dispensing, before or after administration of 17 | |
78 | - | the drug. 18 | |
79 | + | (1) a designated pharmacy or other source authorized under the Health 19 | |
80 | + | Occupations Article to dispense or administer prescription drugs; or 20 | |
79 | 81 | ||
80 | - | ( | |
81 | - | ||
82 | + | (2) a pharmacy participating in the entity’s provider network, if the entity 21 | |
83 | + | determines that the pharmacy: 22 | |
82 | 84 | ||
83 | - | (d) Subject to SUBSECTION (H) OF THIS SECTION AND § 15–805 of this subtitle 21 | |
84 | - | [and], notwithstanding § 15–806 of this subtitle, [nothing in] AND EXCEPT AS PROVID ED 22 | |
85 | - | IN § 15–847.2 OF THIS SUBTITLE , this article or regulations adopted under this article 23 | |
86 | - | [precludes] DO NOT PRECLUDE an entity subject to this section from requiring a covered 24 | |
87 | - | specialty drug to be obtained through: 25 | |
85 | + | (i) meets the entity’s performance standards; and 23 | |
88 | 86 | ||
89 | - | (1) a designated pharmacy or other source authorized under the Health 26 | |
90 | - | Occupations Article to dispense or administer prescription drugs; or 27 | |
87 | + | (ii) accepts the entity’s network reimbursement rates. 24 | |
91 | 88 | ||
92 | - | (2) a pharmacy participating in the entity’s provider network, if the entity 28 | |
93 | - | determines that the pharmacy: 29 | |
89 | + | 15–847.2. 25 | |
94 | 90 | ||
95 | - | (i) meets the entity’s performance standards; and 30 | |
91 | + | (A) IN THIS SECTION, “SPECIALTY DRUG ” HAS THE MEANING STAT ED IN § 26 | |
92 | + | 15–847 OF THIS SUBTITLE . 27 | |
96 | 93 | ||
97 | - | (ii) accepts the entity’s network reimbursement rates. 31 HOUSE BILL 1243 3 | |
94 | + | (B) (1) THIS SECTION APPLIES TO: 28 | |
95 | + | HOUSE BILL 1243 3 | |
96 | + | ||
97 | + | ||
98 | + | (I) INSURERS AND NONPROF IT HEALTH SERVICE PLANS THAT 1 | |
99 | + | PROVIDE COVERAGE FOR PRESCRIPTION DRUGS U NDER INDIVIDUAL , GROUP, OR 2 | |
100 | + | BLANKET HEALTH INSUR ANCE POLICIES OR CON TRACTS THAT ARE ISSU ED OR 3 | |
101 | + | DELIVERED IN THE STATE; AND 4 | |
102 | + | ||
103 | + | (II) HEALTH MAINTENANCE O RGANIZATIONS THAT PR OVIDE 5 | |
104 | + | COVERAGE FOR PRESCRI PTION DRUGS UNDER IN DIVIDUAL OR GROUP CO NTRACTS 6 | |
105 | + | THAT ARE ISSUED OR D ELIVERED IN THE STATE. 7 | |
106 | + | ||
107 | + | (2) AN INSURER, A NONPROFIT HEALTH S ERVICE PLAN, OR A HEALTH 8 | |
108 | + | MAINTENANCE ORGANIZA TION THAT PROVIDES C OVERAGE FOR PRESCRIP TION 9 | |
109 | + | DRUGS THROUGH A PHAR MACY BENEFITS MA NAGER IS SUBJECT TO THE 10 | |
110 | + | REQUIREMENTS OF THIS SECTION. 11 | |
111 | + | ||
112 | + | (C) AN ENTITY SUBJECT TO THIS SECTION MAY NOT EXCLUDE COVERAGE 12 | |
113 | + | FOR A COVERED SPECIA LTY DRUG ADMINISTERE D OR DISPENSED BY A PROVIDER 13 | |
114 | + | UNDER § 12–102 OF THE HEALTH OCCUPATIONS ARTICLE IF THE ENTITY 14 | |
115 | + | DETERMINES THAT: 15 | |
116 | + | ||
117 | + | (1) THE PROVIDER THAT AD MINISTERS OR DISPENS ES THE COVERED 16 | |
118 | + | SPECIALTY DRUG : 17 | |
119 | + | ||
120 | + | (I) IS AN IN–NETWORK PROVIDER OF COVERED MEDICAL 18 | |
121 | + | ONCOLOGY SERVICES ; AND 19 | |
122 | + | ||
123 | + | (II) COMPLIES WITH STATE REGULATIONS FOR THE 20 | |
124 | + | ADMINISTERING AND DI SPENSING OF SPECIALT Y DRUGS; AND 21 | |
125 | + | ||
126 | + | (2) THE COVERED SPECIALT Y DRUG IS: 22 | |
127 | + | ||
128 | + | (I) INFUSED, AUTO–INJECTED, OR AN ORAL TARGETED 23 | |
129 | + | IMMUNE MODULATOR ; OR 24 | |
130 | + | ||
131 | + | (II) AN ORAL MEDICATION T HAT: 25 | |
132 | + | ||
133 | + | 1. REQUIRES COMPLEX DOS ING BASED ON CLINICA L 26 | |
134 | + | PRESENTATION ; OR 27 | |
135 | + | ||
136 | + | 2. IS USED CONCOMITANTL Y WITH OTHER INFUSION OR 28 | |
137 | + | RADIATION THERAPIES . 29 | |
138 | + | ||
139 | + | (D) THE REIMBURSEMENT RAT E FOR SPECIALTY DRUG S COVERED UNDER 30 | |
140 | + | THIS SECTION SHALL B E: 31 4 HOUSE BILL 1243 | |
98 | 141 | ||
99 | 142 | ||
100 | 143 | ||
101 | - | (H) THIS SECTION MAY NOT BE CONSTRUED TO SUPE RSEDE THE AUTHORITY 1 | |
102 | - | OF THE HEALTH SERVICES COST REVIEW COMMISSION TO SET RAT ES FOR 2 | |
103 | - | SPECIALTY DRUGS ADMI NISTERED TO PATIENTS IN A SETTING REGULAT ED BY THE 3 | |
104 | - | HEALTH SERVICES COST REVIEW COMMISSION. 4 | |
144 | + | (1) AGREED TO BY THE COV ERED, IN–NETWORK PROVIDER AND THE 1 | |
145 | + | ENTITY SUBJECT TO TH IS SECTION; AND 2 | |
105 | 146 | ||
106 | - | 15–847.2. 5 | |
147 | + | (2) BILLED AT A NONHOSPI TAL LEVEL OF CARE OR PLA CE OF 3 | |
148 | + | SERVICE. 4 | |
107 | 149 | ||
108 | - | (A) IN THIS SECTION, “SPECIALTY DRUG ” HAS THE MEANING STAT ED IN § 6 | |
109 | - | 15–847 OF THIS SUBTITLE . 7 | |
150 | + | (E) THIS SECTION DOES NOT PROHIBIT AN ENTITY S UBJECT TO THIS 5 | |
151 | + | SECTION FROM REFUSIN G TO AUTHORIZE OR AP PROVE OR FROM DENYIN G 6 | |
152 | + | COVERAGE FOR A COVER ED SPECIALTY DRUG AD MINISTERED OR DISPEN SED BY A 7 | |
153 | + | PROVIDER IF ADMINIST ERING OR DISPENSING THE DRU G FAILS TO SATISFY 8 | |
154 | + | MEDICAL NECESSITY CR ITERIA. 9 | |
110 | 155 | ||
111 | - | ||
156 | + | 15–1611.1. 10 | |
112 | 157 | ||
113 | - | (I) INSURERS AND NONPROF IT HEALTH SERVICE PL ANS THAT 9 | |
114 | - | PROVIDE COVERAGE FOR PRESCRIPTION DRUGS UNDER INDIVIDUAL , GROUP, OR 10 | |
115 | - | BLANKET HEALTH INSUR ANCE POLICIES OR CON TRACTS THAT ARE ISSU ED OR 11 | |
116 | - | DELIVERED IN THE STATE; AND 12 | |
158 | + | (a) This section applies only to a pharmacy benefits manager that provides 11 | |
159 | + | pharmacy benefits management services on behalf of a carrier. 12 | |
117 | 160 | ||
118 | - | ( | |
119 | - | ||
120 | - | ||
161 | + | (b) Except as provided in subsection (c) of this section, a pharmacy benefits 13 | |
162 | + | manager may not require that a beneficiary use a specific pharmacy or entity to fill a 14 | |
163 | + | prescription if: 15 | |
121 | 164 | ||
122 | - | (2) AN INSURER, A NONPROFIT HEALTH S ERVICE PLAN, OR A HEALTH 16 | |
123 | - | MAINTENANCE ORGANIZA TION THAT PROVIDES C OVERAGE FOR PRESCRIP TION 17 | |
124 | - | DRUGS THROUGH A PHAR MACY BENEFITS MANAGE R IS SUBJECT TO THE 18 | |
125 | - | REQUIREMENTS OF THIS SECTION. 19 | |
165 | + | (1) the pharmacy benefits manager or a corporate affiliate of the pharmacy 16 | |
166 | + | benefits manager has an ownership interest in the pharmacy or entity; or 17 | |
126 | 167 | ||
127 | - | (C) AN ENTITY SUBJECT TO THIS SECTION MAY NOT EXCLUDE COVERAGE 20 | |
128 | - | FOR A COVERED SPECIA LTY DRUG ADMINISTERE D OR DISPENSED BY A PROVIDER 21 | |
129 | - | UNDER § 12–102 OF THE HEALTH OCCUPATIONS ARTICLE IF THE ENTITY 22 | |
130 | - | DETERMINES THAT : 23 | |
168 | + | (2) the pharmacy or entity has an ownership interest in the pharmacy 18 | |
169 | + | benefits manager or a corporate affiliate of the pharmacy benefits manager. 19 | |
131 | 170 | ||
132 | - | (1) THE PROVIDER THAT AD MINISTERS OR DISPENSES THE COVERE D 24 | |
133 | - | SPECIALTY DRUG : 25 | |
171 | + | (c) [A] EXCEPT AS PROVIDED IN § 15–847.2 OF THIS TITLE, A pharmacy 20 | |
172 | + | benefits manager may require a beneficiary to use a specific pharmacy or entity for a 21 | |
173 | + | specialty drug as defined in § 15–847 of this title. 22 | |
134 | 174 | ||
135 | - | (I) IS AN IN–NETWORK PROVIDER OF COVERED MEDICAL 26 | |
136 | - | ONCOLOGY SERVICES ; AND 27 | |
175 | + | 15–1612. 23 | |
137 | 176 | ||
138 | - | ( | |
139 | - | ||
177 | + | (a) This section applies only to a pharmacy benefits manager that provides 24 | |
178 | + | pharmacy benefits management services on behalf of a carrier. 25 | |
140 | 179 | ||
141 | - | (2) THE COVERED SPECIALT Y DRUG IS: 30 | |
142 | - | 4 HOUSE BILL 1243 | |
180 | + | (b) This section does not apply to reimbursement: 26 | |
181 | + | ||
182 | + | (1) EXCEPT AS PROVIDED I N § 15–847.2 OF THIS TITLE, for specialty 27 | |
183 | + | drugs; 28 | |
184 | + | ||
185 | + | (2) for mail order drugs; or 29 | |
186 | + | ||
187 | + | (3) to a chain pharmacy with more than 15 stores or a pharmacist who is 30 | |
188 | + | an employee of the chain pharmacy. 31 HOUSE BILL 1243 5 | |
143 | 189 | ||
144 | 190 | ||
145 | - | (I) INFUSED, AUTO–INJECTED, OR AN ORAL TARGETED 1 | |
146 | - | IMMUNE MODULATOR ; OR 2 | |
147 | 191 | ||
148 | - | (II) AN ORAL MEDICATION T HAT: 3 | |
192 | + | (c) A pharmacy benefits manager may not reimburse a pharmacy or pharmacist 1 | |
193 | + | for a pharmaceutical product or pharmacist service in an amount less than the amount that 2 | |
194 | + | the pharmacy benefits manager reimburses itself or an affiliate for providing the same 3 | |
195 | + | product or service. 4 | |
149 | 196 | ||
150 | - | 1. REQUIRES COMPLEX DOS ING BASED ON CLINICA L 4 | |
151 | - | PRESENTATION ; OR 5 | |
197 | + | SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 5 | |
198 | + | policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 6 | |
199 | + | after January 1, 2026. 7 | |
152 | 200 | ||
153 | - | | |
154 | - | ||
201 | + | SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect 8 | |
202 | + | January 1, 2026. 9 | |
155 | 203 | ||
156 | - | (D) (1) THE SUBJECT TO SUBSECTION (F) OF THIS SECTION , THE 8 | |
157 | - | REIMBURSEMENT RATE F OR SPECIALTY DRUGS COVE RED UNDER THIS SECTI ON 9 | |
158 | - | SHALL BE: 10 | |
159 | - | ||
160 | - | (1) (I) AGREED TO BY THE COV ERED, IN–NETWORK PROVIDER AND 11 | |
161 | - | THE ENTITY SUBJECT T O THIS SECTION; AND 12 | |
162 | - | ||
163 | - | (2) (II) BILLED AT A NONHOSPITAL LEVEL OF CARE OR PLACE OF 13 | |
164 | - | SERVICE. 14 | |
165 | - | ||
166 | - | (2) UNLESS OTHERWISE AGRE ED TO BY THE COVERED , IN–NETWORK 15 | |
167 | - | PROVIDER AND THE ENT ITY SUBJECT TO THIS SECTION, THE REIMBURSEMENT RA TE 16 | |
168 | - | FOR SPECIALTY DRUGS COVERED UNDER THIS S ECTION MAY NOT EXCEE D THE RATE 17 | |
169 | - | APPLICABLE TO A DESI GNATED SPECIALTY PHA RMACY FOR DISPENSING THE 18 | |
170 | - | COVERED SPECIALTY DR UGS. 19 | |
171 | - | ||
172 | - | (E) THIS SECTION DOES NOT PROHIBIT AN ENTITY S UBJECT TO THIS 20 | |
173 | - | SECTION FROM REFUSIN G TO AUTHORIZE OR AP PROVE OR FROM DENYIN G 21 | |
174 | - | COVERAGE FOR A COVER ED SPECIALTY DRUG ADMINISTERED OR DISP ENSED BY A 22 | |
175 | - | PROVIDER IF ADMINIST ERING OR DISPENSING THE DRUG FAILS TO SA TISFY 23 | |
176 | - | MEDICAL NECESSITY CR ITERIA. 24 | |
177 | - | ||
178 | - | (F) THIS SECTION MAY NOT BE CONSTRUED TO SUPE RSEDE THE AUTHORITY 25 | |
179 | - | OF THE HEALTH SERVICES COST REVIEW COMMISSION TO SET RAT ES FOR 26 | |
180 | - | SPECIALTY DRUGS ADMIN ISTERED TO PATIENTS IN A SETTING REGULAT ED BY THE 27 | |
181 | - | HEALTH SERVICES COST REVIEW COMMISSION. 28 | |
182 | - | ||
183 | - | 15–1611.1. 29 | |
184 | - | ||
185 | - | (a) This section applies only to a pharmacy benefits manager that provides 30 | |
186 | - | pharmacy benefits management services on behalf of a carrier. 31 | |
187 | - | HOUSE BILL 1243 5 | |
188 | - | ||
189 | - | ||
190 | - | (b) Except as provided in subsection (c) of this section, a pharmacy benefits 1 | |
191 | - | manager may not require that a beneficiary use a specific pharmacy or entity to fill a 2 | |
192 | - | prescription if: 3 | |
193 | - | ||
194 | - | (1) the pharmacy benefits manager or a corporate affiliate of the pharmacy 4 | |
195 | - | benefits manager has an ownership interest in the pharmacy or entity; or 5 | |
196 | - | ||
197 | - | (2) the pharmacy or entity has an ownership interest in the pharmacy 6 | |
198 | - | benefits manager or a corporate affiliate of the pharmacy benefits manager. 7 | |
199 | - | ||
200 | - | (c) [A] EXCEPT AS PRO VIDED IN § 15–847.2 OF THIS TITLE, A pharmacy 8 | |
201 | - | benefits manager may require a beneficiary to use a specific pharmacy or entity for a 9 | |
202 | - | specialty drug as defined in § 15–847 of this title. 10 | |
203 | - | ||
204 | - | 15–1612. 11 | |
205 | - | ||
206 | - | (a) This section applies only to a pharmacy benefits manager that provides 12 | |
207 | - | pharmacy benefits management services on behalf of a carrier. 13 | |
208 | - | ||
209 | - | (b) This section does not apply to reimbursement: 14 | |
210 | - | ||
211 | - | (1) EXCEPT AS PROVIDED I N § 15–847.2 OF THIS TITLE, for specialty 15 | |
212 | - | drugs; 16 | |
213 | - | ||
214 | - | (2) for mail order drugs; or 17 | |
215 | - | ||
216 | - | (3) to a chain pharmacy with more than 15 stores or a pharmacist who is 18 | |
217 | - | an employee of the chain pharmacy. 19 | |
218 | - | ||
219 | - | (c) A pharmacy benefits manager may not reimburse a pharmacy or pharmacist 20 | |
220 | - | for a pharmaceutical product or pharmacist service in an amount less than the amount that 21 | |
221 | - | the pharmacy benefits manager reimburses itself or an affiliate for providing the same 22 | |
222 | - | product or service. 23 | |
223 | - | ||
224 | - | SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 24 | |
225 | - | policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 25 | |
226 | - | after January 1, 2026. 26 | |
227 | - | ||
228 | - | SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect 27 | |
229 | - | January 1, 2026. 28 |