Maryland 2025 Regular Session

Maryland Senate Bill SB393 Compare Versions

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

Old	New	Differences
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	5	sb0393
6	6
7	7	SENATE BILL 393
8	8	J5 5lr2195
9	9	CF 5lr3212
10	10	By: Senator Lam
11	11	Introduced and read first time: January 17, 2025
12	12	Assigned to: Finance
13	13
14	14	A BILL ENTITLED
15	15
16	16	AN ACT concerning 1
17	17
18	18	Health Insurance – Prescription Drug Formularies and Coverage for Generic 2
19	19	Drugs and Biosimilars 3
20	20
21	21	FOR the purpose of requiring certain carriers to post certain prescription drug formularies 4
22	22	and changes to the formularies in a certain manner on a carrier’s website; requiring 5
23	23	certain insurers, nonprofit health service plans, and health maintenance 6
24	24	organizations to make certain generic drugs and biosimilars available on a formulary 7
25	25	with certain cost sharing; and generally relating to prescription drug formularies, 8
26	26	generic drugs, and biosimilars. 9
27	27
28	28	BY adding to 10
29	29	Article – Insurance 11
30	30	Section 15–147 and 15–861 12
31	31	Annotated Code of Maryland 13
32	32	(2017 Replacement Volume and 2024 Supplement) 14
33	33
34	34	SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 15
35	35	That the Laws of Maryland read as follows: 16
36	36
37	37	Article – Insurance 17
38	38
39	39	15–147. 18
40	40
41	41	(A) (1) IN THIS SECTION THE F OLLOWING WORDS HAVE THE MEANINGS 19
42	42	INDICATED. 20
43	43
44	44	(2) “CARRIER” MEANS: 21
45	45
46	46	(I) AN INSURER; 22
47	47	2 SENATE BILL 393
48	48
49	49
50	50	(II) A NONPROFIT HEALTH S ERVICE PLAN; 1
51	51
52	52	(III) A HEALTH MAINTENANCE ORGANIZA TION; 2
53	53
54	54	(IV) A DENTAL PLAN ORGANI ZATION; OR 3
55	55
56	56	(V) ANY OTHER PERSON THA T PROVIDES HEALTH BE NEFIT 4
57	57	PLANS SUBJECT TO REG ULATION BY THE STATE. 5
58	58
59	59	(3) “ENROLLEE” MEANS A PERSON ENTIT LED TO HEALTH CARE 6
60	60	BENEFITS FROM A CARR IER. 7
61	61
62	62	(4) “FORMULARY ” MEANS A LIST OF PRES CRIPTION DRUGS THAT IS 8
63	63	DEVELOPED BY A CARRI ER’S PHARMACY AND THERA PEUTICS COMMITTEE OR 9
64	64	OTHER CLINICAL AND P HARMACY EXPERTS AND REPRESENTS THE PRESCRIPTION 10
65	65	DRUGS APPROVED FOR C OVERAGE UNDER A HEALTH BENEFIT PLA N. 11
66	66
67	67	(B) EACH CARRIER SHALL POST ON ITS WEBSITE AN UPDATED, ACCURATE, 12
68	68	AND COMPLETE FORMULARY THAT IS EASILY ACCES SIBLE TO AN ENROLLEE, A 13
69	69	PROSPECTIVE ENROLLEE, THE STATE, AND THE PUBLIC . 14
70	70
71	71	(C) (1) A FORMULARY POSTED UNDER SUBSECT ION (B) OF THIS SECTION 15
72	72	SHALL: 16
73	73
74	74	(I) BE CLEARLY IDENTIFIED BY A LINK OR TAB ON THE 17
75	75	CARRIER’S WEBSITE; 18
76	76
77	77	(II) INCLUDE ANY TIERING STRUCT URE; AND 19
78	78
79	79	(III) INDICATE ANY RESTRIC TIONS ON THE MANNER IN WHICH A 20
80	80	DRUG MAY BE OBTAINED . 21
81	81
82	82	(2) A CARRIER MAY NOT REQU IRE AN INDIVIDUAL TO CREATE OR 22
83	83	ACCESS AN ACCOUNT OR ENTER A POLICY NUMBER ON T HE CARRIER’S WEBSITE TO 23
84	84	VIEW A FORMULARY POSTED UNDER SUBSECTION (B) OF THIS SECTION. 24
85	85
86	86	(D) IF A CARRIER OFFERS MOR E THAN ONE PRESCRIPT ION DRUG BENEFIT 25
87	87	PLAN, THE CARRIER ’S WEBSITE SHALL CLEARLY INDICA TE WHICH FORMULARY 26
88	88	APPLIES TO WHICH PLA N. 27
89	89
90	90	(E) IF A CARRIER MAKES A CHANGE TO A FORMULARY DURING A PLAN YEAR, 28
91	91	WITHIN 30 DAYS AFTER THE DATE THE C HANGE WAS MADE , THE CARRIER SHALL : 29
92	92	SENATE BILL 393 3
93	93
94	94
95	95	(1) UPDATE THE FORMULARY POSTED ON THE CARRIE R’S WEBSITE 1
96	96	UNDER SUBSECTION (B) OF THIS SECTION; AND 2
97	97
98	98	(2) CLEARLY AND IN BOLD TYPE INDICATE THE DATE THE CHANGE 3
99	99	WAS MADE AND A DESCRIPTION OF THE CHANGE ON THE CARRIER’S WEBSITE. 4
100	100
101	101	15–861. 5
102	102
103	103	(A) (1) IN THIS SECTION THE F OLLOWING WORDS HAVE THE MEANI NGS 6
104	104	INDICATED. 7
105	105
106	106	(2) “BIOSIMILAR” MEANS A BIOLOGICAL PRODUCT T HAT IS LICENSED 8
107	107	UNDER 42 U.S.C. § 262(K) AND HAS BEEN LISTED IN THE FDA’S DATABASE OF 9
108	108	LICENSED BIOLOGICAL PRODUCTS AS BIOSIMILA R TO OR INTERCHANGEA BLE WITH 10
109	109	A REFERENCE PRODUCT. 11
110	110
111	111	(3) “BRAND DRUG” MEANS A DRUG FOR WHI CH AN APPLICATION HA S 12
112	112	BEEN APPROVED UNDER 21 U.S.C. § 355(C) OR A BIOLOGICAL PROD UCT OTHER 13
113	113	THAN A BIOSIMILAR TH AT IS LICENSED UNDER 42 U.S.C. § 262(A). 14
114	114
115	115	(4) “FDA” MEANS THE FEDERAL FOOD AND DRUG ADMINISTRATION. 15
116	116
117	117	(5) “FORMULARY ” MEANS A LIST OF PRES CRIPTION DRUGS THAT IS 16
118	118	DEVELOPED BY A CARRIER’S PHARMACY AND THERAPE UTICS COMMITTEE OR 17
119	119	OTHER CLINICAL AND P HARMACY EXPERTS AND REPRESENTS THE PRESCRIPTION 18
120	120	DRUGS APPROVED FOR C OVERAGE UNDER A HEAL TH BENEFIT PLAN . 19
121	121
122	122	(6) “GENERIC DRUG ” MEANS A DRUG FOR WHI CH AN APPLICATION 20
123	123	HAS BEEN APPROVED UN DER 21 U.S.C. § 355(J) AND THAT HAS BEEN LISTED IN T HE 21
124	124	FDA’S APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE 22
125	125	EVALUATIONS AS THERAP EUTICALLY EQUIVALENT TO A REFERENCE LISTED DRUG, 23
126	126	INCLUDING A DRUG TO WHICH THE MANUFACTURER OF THE DRUG APPLIES A TRADE 24
127	127	NAME. 25
128	128
129	129	(7) “REFERENCE LISTED DRUG ” MEANS A PREVIOUSLY APPROVE D 26
130	130	DRUG IDENTIFIED BY T HE FDA AS THE DRUG PRODUCT TO WHICH A PROPOSED 27
131	131	GENERIC DRUG MUST BE COMPARED ON AN APPLICATION SUBMITTE D FOR 28
132	132	APPROVAL UNDER 21 U.S.C. § 355(J). 29
133	133
134	134	(8) “REFERENCE PRODUCT ” MEANS A SINGLE BIOLOGICAL PRODUCT 30
135	135	THAT IS LICENSED BY THE FDA UNDER 42 U.S.C. § 262(A) AGAINST WHICH A 31
136	136	PROPOSED BIOSIMILAR OR INTERCHANGEABLE P RODUCT IS COMPARED AND THAT 32 4 SENATE BILL 393
137	137
138	138
139	139	IS LISTED AS A REFERENC E PRODUCT IN THE FDA’S DATABASE OF LICENSED 1
140	140	BIOLOGICAL PRODUCTS. 2
141	141
142	142	(9) “WHOLESALE ACQUISITION COST” MEANS, WITH RESPECT TO A 3
143	143	DRUG OR BIOLOGICAL P RODUCT, THE MANUFACTURER ’S LIST PRICE FOR THE DRUG 4
144	144	OR THE BIOLOGICAL PR ODUCT TO WHOLESALERS OR DIREC T PURCHASERS IN THE 5
145	145	UNITED STATES, NOT INCLUDING PROMPT PAY OR OTHER DISCOUN TS, REBATES, OR 6
146	146	REDUCTIONS IN PRICE , FOR THE MOST RECENT MONTH FOR WHICH THE 7
147	147	INFORMATION IS AVAIL ABLE AS REPORTED IN WHOLE SALE PRICE GUIDES OR OTHER 8
148	148	PUBLICATION S OF DRUG OR BIOLOGI CAL PRODUCT PRICING DATA. 9
149	149
150	150	(B) (1) THIS SECTION APPLIES TO: 10
151	151
152	152	(I) INSURERS AND NONPROF IT HEALTH SERVICE PL ANS THAT 11
153	153	PROVIDE COVERAGE FOR PRESCRIPTION DRUGS A ND DEVICES TO INDIVI DUALS OR 12
154	154	GROUPS UNDER HEALTH INSURANCE POLICIES O R CONTRA CTS THAT ARE 13
155	155	DELIVERED IN THE STATE; 14
156	156
157	157	(II) HEALTH MAINTENANCE O RGANIZATIONS THAT PR OVIDE 15
158	158	COVERAGE FOR PRESCRI PTION DRUGS AND DEVI CES TO INDIVIDUALS O R GROUPS 16
159	159	UNDER CONTRACTS THAT ARE ISSUED OR DELIVE RED IN THE STATE; AND 17
160	160
161	161	(III) INSURERS, NONPROFIT HE ALTH SERVICE PLAN S, OR 18
162	162	HEALTH MAINTENANCE O RGANIZATION S THAT PROVIDE COVERAG E FOR 19
163	163	PRESCRIPTION DRUGS A ND DEVICES THROUGH A PHARMACY BENEFITS MA NAGER. 20
164	164
165	165	(2) THIS SECTION DOES NOT APPLY TO A MANAGED C ARE 21
166	166	ORGANIZATION AS DEFI NED IN § 15–101 OF THE HEALTH – GENERAL ARTICLE. 22
167	167
168	168	(C) (1) EXCEPT AS PROVIDED IN PARAGRAPH (3) OF THIS SUBSECTION , 23
169	169	AN ENTITY SUBJECT TO THIS SECTION THAT PR OVIDES COVERAGE FOR THE 24
170	170	REFERENCE LISTED DRU G FOR A GENERIC DRUG SHALL IMMEDIATELY MA KE THE 25
171	171	GENERIC DRUG AVAILAB LE ON A FORMULARY WI TH MORE FAVORABLE CO ST 26
172	172	SHARING THAN THE REFERENCE LISTED DRUG IF THE GENERIC DRU G: 27
173	173
174	174	(I) IS APPROVED BY THE FDA; 28
175	175
176	176	(II) IS MARKETED AS A GENERIC DRUG AP PROVED BY THE FDA; 29
177	177	AND 30
178	178
179	179	(III) HAS A WHOLESALE ACQUISITION COST THA T IS LESS THAN 31
180	180	THE WHOLESALE ACQUIS ITION COST OF THE RE FERENCE LISTED DRUG ON THE 32
181	181	INITIAL DATE OF MARK ETING FOR THE GENERIC DRUG . 33 SENATE BILL 393 5
182	182
183	183
184	184
185	185	(2) AN ENTITY SUBJECT TO THIS SECTION MAY NOT IMPOSE: 1
186	186
187	187	(I) A PRIOR AUTHORIZATIO N OR STEP THERAPY REQUIREMENT 2
188	188	OR OTHER LIMITATION ON THE COVERAGE FOR A GENER IC DRUG ADDED TO A 3
189	189	FORMULARY UNDER PARAGRAPH (1) OF THIS SUBSECTION ; OR 4
190	190
191	191	(II) A RESTRICTION ON A P HARMACY THAT MAKES I T MORE 5
192	192	DIFFICULT FOR AN ENROLLEE TO OBTAIN COVERAGE FOR OR ACCE SS TO A GENERIC 6
193	193	DRUG ADDED TO A FORMULARY UNDER PARAGRAPH (1) OF THIS SUBSECTION THAN 7
194	194	IT IS FOR THE ENROLL EE TO OBTAIN COVERAG E FOR OR ACCESS TO THE REFERENCE 8
195	195	LISTED DRUG. 9
196	196
197	197	(3) THIS SUBSECTION DOES NOT APPLY IF THE WHOLESALE 10
198	198	ACQUISITION COST OF THE GENERIC DRUG BECOMES GREATER THAN THE 11
199	199	WHOLESALE ACQUISITIO N COST OF THE REFERE NCE LISTED DRUG . 12
200	200
201	201	(D) (1) EXCEPT AS PROVIDED IN PARAGRAPH (3) OF THIS SUBSECTION , 13
202	202	AN ENTITY SUBJECT TO THIS SECTION THAT PROVIDES COVERA GE FOR A 14
203	203	REFERENCE PRODUCT FOR A BIOSIMILAR SHALL IMMEDIATELY MAKE AT LEAST ONE 15
204	204	BIOSIMILAR FOR THE REFERENCE PRODUCT AVAILABLE ON THE ENTITY’S 16
205	205	FORMULARY WITH MORE FAVORABLE COST SHARING THAN THE REFERENCE 17
206	206	PRODUCT IF THE BIOSIMILAR : 18
207	207
208	208	(I) IS LICENSED BY THE FDA; 19
209	209
210	210	(II) IS MARKETED AS A BIOSIMILAR LICENSED BY THE FDA; AND 20
211	211
212	212	(III) HAS A WHOLESALE ACQU ISITION COST THAT IS LESS THAN 21
213	213	THE WHOLESALE ACQUIS ITION COST OF THE RE FERENCE PRODUCT ON THE INITIAL 22
214	214	DATE OF MARKETING FOR THE BIOSIMILAR . 23
215	215
216	216	(2) AN ENTITY SUBJECT TO THIS SECTION MAY NOT IMPOSE: 24
217	217
218	218	(I) A PRIOR AUTHORIZATIO N OR STEP THERAPY RE QUIREMENT 25
219	219	OR OTHER LIMITATION ON THE COVERAGE FOR A BIOSI MILAR ADDED TO A 26
220	220	FORMULARY UNDER PARAGRAPH (1) OF THIS SUBSECTION ; OR 27
221	221
222	222	(II) A RESTRICTION ON A P HARMACY THAT MAKES I T MORE 28
223	223	DIFFICULT FOR AN ENROLLEE TO OBTAIN COVERAGE F OR OR ACCESS TO A 29
224	224	BIOSIMILAR ADDED TO A FORMULARY UNDER PARAGRAPH (1) OF THIS SUBSECTION 30
225	225	THAN IT IS FOR THE ENROLL EE TO OBTAIN COVERAG E FOR OR ACCESS TO THE 31
226	226	REFERENCE PRODUCT . 32 6 SENATE BILL 393
227	227
228	228
229	229
230	230	(3) THIS SUBSECTION DOES NOT APPLY IF THE WHOLESALE 1
231	231	ACQUISITION COST OF THE BIOSIMILAR BECOMES GREATER THAN THE WHOLESALE 2
232	232	ACQUISITION COST OF THE REFERENCE PRODUC T. 3
233	233
234	234	(E) IF A GENERIC DRUG IS ADDED TO A FORMUL ARY UNDER SUBSECTION (C) 4
235	235	OF THIS SECTION OR A BIOSIMILAR IS ADDED TO A FORMULARY UNDER SUBSECTION 5
236	236	(D) OF THIS SECTION , AN ENTITY SUBJECT TO THIS SECTION SHALL I NFORM 6
237	237	ENROLLEES OF THE CHA NGE IN FORMULARY IN ACCORDANCE WITH § 15–147 OF 7
238	238	THIS TITLE. 8
239	239
240	240	(F) THIS SECTION DOES NOT REQUIRE A N ENTITY SUBJECT TO THIS 9
241	241	SECTION TO PROVIDE C OVERAGE FOR A BRAND DRUG AFTER A GENERIC DRUG IS 10
242	242	APPROVED BY THE FDA OR A BIOSIMILAR IS LICENSED BY THE FDA AND 11
243	243	MARKETED, AS APPLICABLE. 12
244	244
245	245	(G) THIS SECTION DOES NOT REQUIRE A N ENTITY SUBJECT TO THIS 13
246	246	SECTION TO PROVIDE C OVERAGE FOR A BRAND DRUG, GENERIC DRUG , OR 14
247	247	BIOSIMILAR IF THE PHARMACY AND THERAPE UTICS COMMITTEE OR O THER 15
248	248	CLINICAL AND PHARMAC Y EXPERTS THAT DEVEL OP THE ENTITY’S FORMULARY 16
249	249	DETERMINE THAT THE B RAND DRUG, GENERIC DRUG , OR BIOSIMILAR IS NO LONGER 17
250	250	MEDICALLY APPROPRIAT E OR COST–EFFECTIVE. 18
251	251
252	252	(H) THIS SECTION MAY NOT BE CONSTRUED TO INTERFERE WITH A 19
253	253	PHARMACIST COMPLYING WITH THE MARYLAND PHARMACY ACT. 20
254	254
255	255	(I) THE COMMISSIONER MAY ADOPT REGULATION S TO CARRY OUT THIS 21
256	256	SECTION. 22
257	257
258	258	SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 23
259	259	policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 24
260	260	after January 1, 2026. 25
261	261
262	262	SECTION 3. AND BE IT FURTHER ENACTED, T hat this Act shall take effect 26
263	263	January 1, 2026. 27