Maryland 2025 Regular Session

Maryland Senate Bill SB111 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	sb0111
6	6
7	7	SENATE BILL 111
8	8	J5, J4, J1 5lr1291
9	9	(PRE–FILED)
10	10	By: Senator Lam
11	11	Requested: October 21, 2024
12	12	Introduced and read first time: January 8, 2025
13	13	Assigned to: Finance
14	14
15	15	A BILL ENTITLED
16	16
17	17	AN ACT concerning 1
18	18
19	19	Maryland Medical Assistance Program and Health Insurance – Step Therapy, 2
20	20	Fail–First Protocols, and Prior Authorization – Prescription to Treat Serious 3
21	21	Mental Illness 4
22	22
23	23	FOR the purpose of prohibiting the Maryland Medical Assistance Program and certain 5
24	24	insurers, nonprofit health service plans, health maintenance organizations, and 6
25	25	managed care organizations from applying a prior authorization requirement, step 7
26	26	therapy protocol, or fail–first protocol for prescription drugs used to treat certain 8
27	27	mental illnesses of certain insureds and enrollees; and generally relating to coverage 9
28	28	of prescription drugs to treat serious mental illness. 10
29	29
30	30	BY adding to 11
31	31	Article – Health – General 12
32	32	Section 15–102.3(m) and 15–157 13
33	33	Annotated Code of Maryland 14
34	34	(2023 Replacement Volume and 2024 Supplement) 15
35	35
36	36	BY repealing and reenacting, with amendments, 16
37	37	Article – Insurance 17
38	38	Section 15–142 18
39	39	Annotated Code of Maryland 19
40	40	(2017 Replacement Volume and 2024 Supplement) 20
41	41
42	42	BY adding to 21
43	43	Article – Insurance 22
44	44	Section 15–851.1 23
45	45	Annotated Code of Maryland 24
46	46	(2017 Replacement Volume and 2024 Supplement) 25
47	47	2 SENATE BILL 111
48	48
49	49
50	50	SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 1
51	51	That the Laws of Maryland read as follows: 2
52	52
53	53	Article – Health – General 3
54	54
55	55	15–102.3. 4
56	56
57	57	(M) THE PROVISIONS OF §§ 15–142(E)(2) AND 15–851.1 OF THE INSURANCE 5
58	58	ARTICLE APPLY TO MANA GED CARE ORGANIZATIO NS. 6
59	59
60	60	15–157. 7
61	61
62	62	(A) IN THIS SECTION, “STEP THERAPY OR FAIL–FIRST PROTOCOL” HAS THE 8
63	63	MEANING STATED IN § 15–142 OF THE INSURANCE ARTICLE. 9
64	64
65	65	(B) EXCEPT AS REQUIRED UN DER 42 U.S.C. § 1396A, BEGINNING JULY 1, 10
66	66	2025, THE PROGRAM MAY NOT APPLY A PRIOR AUTHORIZATIO N REQUIREMENT FOR 11
67	67	A PRESCRIPTION DRUG USED TO TREAT AN ADULT ENROLLEE’S DIAGNOSIS OF: 12
68	68
69	69	(1) BIPOLAR DISORDER ; 13
70	70
71	71	(2) SCHIZOPHRENIA ; 14
72	72
73	73	(3) MAJOR DEPRESSION ; 15
74	74
75	75	(4) POST–TRAUMATIC STRESS DIS ORDER; OR 16
76	76
77	77	(5) A MEDICATION–INDUCED MOVEMENT DIS ORDER ASSOCIATED 17
78	78	WITH THE TREATMENT O F A SERIOUS MENTAL I LLNESS. 18
79	79
80	80	(C) BEGINNING JULY 1, 2025, THE PROGRAM MAY NOT APPLY A STEP 19
81	81	THERAPY OR FAIL–FIRST PROTOCOL FOR A PRESCRIPTION D RUG USED TO TREAT AN 20
82	82	ENROLLEE’S DIAGNOSIS OF: 21
83	83
84	84	(1) BIPOLAR DISORDER ; 22
85	85
86	86	(2) SCHIZOPHRENIA ; 23
87	87
88	88	(3) MAJOR DEPRESSION ; 24
89	89
90	90	(4) POST–TRAUMATIC STRESS DIS ORDER; OR 25
91	91
92	92	(5) A MEDICATION–INDUCED MOVEMENT DIS ORDER ASSOCIATED 26
93	93	WITH THE TREATMENT OF A SERIOUS MENTAL ILLNESS. 27 SENATE BILL 111 3
94	94
95	95
96	96
97	97	SECTION 2. AND BE IT FURTHER ENACTED, That the Laws of Maryland read 1
98	98	as follows: 2
99	99
100	100	Article – Insurance 3
101	101
102	102	15–142. 4
103	103
104	104	(a) (1) In this section the following words have the meanings indicated. 5
105	105
106	106	(2) “Step therapy drug” means a prescription drug or sequence of 6
107	107	prescription drugs required to be used under a step therapy or fail–first protocol. 7
108	108
109	109	(3) “Step therapy exception request” means a request to override a step 8
110	110	therapy or fail–first protocol. 9
111	111
112	112	(4) (i) “Step therapy or fail–first protocol” means a protocol established 10
113	113	by an insurer, a nonprofit health service plan, or a health maintenance organization that 11
114	114	requires a prescription drug or sequence of prescription drugs to be used by an insured or 12
115	115	an enrollee before a prescription drug ordered by a prescriber for the insured or the enrollee 13
116	116	is covered. 14
117	117
118	118	(ii) “Step therapy or fail–first protocol” includes a protocol that 15
119	119	meets the definition under subparagraph (i) of this paragraph regardless of the name, label, 16
120	120	or terminology used by the insurer, nonprofit health service plan, or health maintenance 17
121	121	organization to identify the protocol. 18
122	122
123	123	(5) “Supporting medical information” means: 19
124	124
125	125	(i) a paid claim from an entity subject to this section for an insured 20
126	126	or an enrollee; 21
127	127
128	128	(ii) a pharmacy record that documents that a prescription has been 22
129	129	filled and delivered to an insured or an enrollee, or a representative of an insured or an 23
130	130	enrollee; or 24
131	131
132	132	(iii) other information mutually agreed on by an entity subject to this 25
133	133	section and the prescriber of an insured or an enrollee. 26
134	134
135	135	(b) (1) This section applies to: 27
136	136
137	137	(i) insurers and nonprofit health service plans that provide hospital, 28
138	138	medical, or surgical benefits to individuals or groups on an expense–incurred basis under 29
139	139	health insurance policies or contracts that are issued or delivered in the State; and 30
140	140	4 SENATE BILL 111
141	141
142	142
143	143	(ii) health maintenance organizations that provide hospital, 1
144	144	medical, or surgical benefits to individuals or groups under contracts that are issued or 2
145	145	delivered in the State. 3
146	146
147	147	(2) An insurer, a nonprofit health service plan, or a health maintenance 4
148	148	organization that provides coverage for prescription drugs through a pharmacy benefits 5
149	149	manager is subject to the requirements of this section. 6
150	150
151	151	(c) An entity subject to this section may not impose a step therapy or fail–first 7
152	152	protocol on an insured or an enrollee if: 8
153	153
154	154	(1) the step therapy drug has not been approved by the U.S. Food and Drug 9
155	155	Administration for the medical condition being treated; or 10
156	156
157	157	(2) a prescriber provides supporting medical information to the entity that 11
158	158	a prescription drug covered by the entity: 12
159	159
160	160	(i) was ordered by a prescriber for the insured or enrollee within the 13
161	161	past 180 days; and 14
162	162
163	163	(ii) based on the professional judgment of the prescriber, was 15
164	164	effective in treating the insured’s or enrollee’s disease or medical condition. 16
165	165
166	166	(d) Subsection (c) of this section may not be construed to require coverage for a 17
167	167	prescription drug that is not: 18
168	168
169	169	(1) covered by the policy or contract of an entity subject to this section; or 19
170	170
171	171	(2) otherwise required by law to be covered. 20
172	172
173	173	(e) An entity subject to this section may not impose a step therapy or fail–first 21
174	174	protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and 22
175	175	Drug Administration if: 23
176	176
177	177	(1) (I) the prescription drug is used to treat the insured’s or enrollee’s 24
178	178	stage four advanced metastatic cancer; and 25
179	179
180	180	[(2)] (II) use of the prescription drug is: 26
181	181
182	182	[(i)] 1. consistent with the U.S. Food and Drug 27
183	183	Administration–approved indication or the National Comprehensive Cancer Network 28
184	184	Drugs & Biologics Compendium indication for the treatment of stage four advanced 29
185	185	metastatic cancer; and 30
186	186
187	187	[(ii)] 2. supported by peer–reviewed medical literature; OR 31
188	188	SENATE BILL 111 5
189	189
190	190
191	191	(2) THE PRESCRIPTION DRU G IS USED TO TREAT THE IN SURED’S OR 1
192	192	ENROLLEE’S DIAGNOSIS OF: 2
193	193
194	194	(I) BIPOLAR DISORDER ; 3
195	195
196	196	(II) SCHIZOPHRENIA ; 4
197	197
198	198	(III) MAJOR DEPRESSION ; 5
199	199
200	200	(IV) POST–TRAUMATIC STRESS DIS ORDER; OR 6
201	201
202	202	(V) A MEDICATION –INDUCED MOVEMENT DIS ORDER 7
203	203	ASSOCIATED WITH THE TREATMENT OF A SERIOUS MENTAL ILLNESS. 8
204	204
205	205	(f) (1) An entity subject to this section shall establish a process for requesting 9
206	206	an exception to a step therapy or fail–first protocol that is: 10
207	207
208	208	(i) clearly described, including the specific information and 11
209	209	documentation, if needed, that must be submitted by the prescriber to be considered a 12
210	210	complete step therapy exception request; 13
211	211
212	212	(ii) easily accessible to the prescriber; and 14
213	213
214	214	(iii) posted on the entity’s website. 15
215	215
216	216	(2) A step therapy exception request shall be granted if, based on the 16
217	217	professional judgment of the prescriber and any information and documentation required 17
218	218	under paragraph (1)(i) of this subsection: 18
219	219
220	220	(i) the step therapy drug is contraindicated or will likely cause an 19
221	221	adverse reaction to the insured or enrollee; 20
222	222
223	223	(ii) the step therapy drug is expected to be ineffective based on the 21
224	224	known clinical characteristics of the insured or enrollee and the known characteristics of 22
225	225	the prescription drug regimen; 23
226	226
227	227	(iii) the insured or enrollee is stable on a prescription drug prescribed 24
228	228	for the medical condition under consideration while covered under the policy or contract of 25
229	229	the entity or under a previous source of coverage; or 26
230	230
231	231	(iv) while covered under the policy or contract of the entity or a 27
232	232	previous source of coverage, the insured or enrollee has tried a prescription drug that: 28
233	233
234	234	1. is in the same pharmacologic class or has the same 29
235	235	mechanism of action as the step therapy drug; and 30
236	236	6 SENATE BILL 111
237	237
238	238
239	239	2. was discontinued by the prescriber due to lack of efficacy 1
240	240	or effectiveness, diminished effect, or an adverse event. 2
241	241
242	242	(3) On granting a step therapy exception request, an entity subject to this 3
243	243	section shall authorize coverage for the prescription drug ordered by the prescriber for an 4
244	244	insured or enrollee. 5
245	245
246	246	(4) An enrollee or insured may appeal a step therapy exception request 6
247	247	denial in accordance with Subtitle 10A or Subtitle 10B of this title. 7
248	248
249	249	(5) This subsection may not be construed to: 8
250	250
251	251	(i) prevent: 9
252	252
253	253	1. an entity subject to this section from requiring an insured 10
254	254	or enrollee to try an AB–rated generic equivalent or interchangeable biological product 11
255	255	before providing coverage for the equivalent branded prescription drug; or 12
256	256
257	257	2. a health care provider from prescribing a prescription 13
258	258	drug that is determined to be medically appropriate; or 14
259	259
260	260	(ii) require an entity subject to this section to provide coverage for a 15
261	261	prescription drug that is not covered by a policy or contract of the entity. 16
262	262
263	263	(6) An entity subject to this section may use an existing step therapy 17
264	264	exception process that satisfies the requirements under this subsection. 18
265	265
266	266	15–851.1. 19
267	267
268	268	(A) (1) THIS SECTION APPLIES TO: 20
269	269
270	270	(I) INSURERS AND NONPROF IT HEALTH SERVICE PL ANS THAT 21
271	271	PROVIDE COVERAGE FOR PRESCRIPTION DRUGS U NDER INDIVIDUAL , GROUP, OR 22
272	272	BLANKET HEALTH INSUR ANCE POLICIES OR CON TRACTS THAT ARE ISSU ED OR 23
273	273	DELIVERED IN THE STATE; AND 24
274	274
275	275	(II) HEALTH MAINTENANCE O RGANIZATIONS THAT PR OVIDE 25
276	276	COVERAGE FOR PRESCRI PTION DRUGS UNDER IN DIVIDUAL OR GROUP CO NTRACTS 26
277	277	THAT ARE ISSUED OR D ELIVERED IN THE STATE. 27
278	278
279	279	(2) AN INSURER, A NONPROFIT HEALTH S ERVICE PLAN, OR A HEALTH 28
280	280	MAINTENANCE ORGANIZA TION THAT PROVIDES C OVERAGE FOR PRESCRIP TION 29
281	281	DRUGS THROUGH A PHAR MACY BENEFITS MANAGE R IS SUBJECT TO THE 30
282	282	REQUIREMENTS OF THIS SECTION. 31
283	283	SENATE BILL 111 7
284	284
285	285
286	286	(B) EXCEPT AS REQUIRE D UNDER 42 U.S.C. § 1396A, AN ENTITY SUBJECT 1
287	287	TO THIS SECTION MAY NOT APPLY A PRIOR AU THORIZATION REQUIREM ENT FOR A 2
288	288	PRESCRIPTION DRUG US ED TO TREAT AN ADULT INSURED’S OR ENROLLEE ’S 3
289	289	DIAGNOSIS OF: 4
290	290
291	291	(1) BIPOLAR DISORDER ; 5
292	292
293	293	(2) SCHIZOPHRENIA ; 6
294	294
295	295	(3) MAJOR DEPRESSION ; 7
296	296
297	297	(4) POST–TRAUMATIC STRESS DIS ORDER; OR 8
298	298
299	299	(5) A MEDICATION –INDUCED MOVEMENT DIS ORDER ASSOCIATED 9
300	300	WITH THE TREATMENT O F A SERIOUS MENTAL I LLNESS. 10
301	301
302	302	SECTION 3. AND BE IT FURTHER ENACTED, That: 11
303	303
304	304	(a) On or before January 31, 2027, and each January 1 thereafter through 2031, 12
305	305	the Maryland Department of Health shall report to the Department of Legislative Services 13
306	306	on any cost increase to the Maryland Medical Assistance Program from the immediately 14
307	307	preceding fiscal year that results from the implementation of Section 1 of this Act. 15
308	308
309	309	(b) On or before April 30 of the year in which a report is submitted under 16
310	310	subsection (a) of this section, the Department of Legislative Services shall determine, based 17
311	311	on the report, whether the implementation of Section 1 of this Act resulted in a cost increase 18
312	312	to the Maryland Medical Assistance Program of more than $2,000,000 from the 19
313	313	immediately preceding fiscal year. 20
314	314
315	315	(c) If the Department of Legislative Services determines that the implementation 21
316	316	of Section 1 of this Act resulted in a cost increase to the Maryland Medical Assistance 22
317	317	Program of more than $2,000,000 from the immediately preceding fiscal year, with no 23
318	318	further action required by the General Assembly, at the end of April 30 of the year the 24
319	319	determination is made, Section 1 of this Act shall be abrogated and of no further force and 25
320	320	effect. 26
321	321
322	322	SECTION 4. AND BE IT FURTHER ENACTED, That Section 2 of this Act shall 27
323	323	apply to all policies, contracts, and health benefit plans issued, delivered, or renewed in the 28
324	324	State on or after January 1, 2026. 29
325	325
326	326	SECTION 5. AND BE IT FURTHER ENACTED, That Section 2 of this Act shall take 30
327	327	effect January 1, 2026. 31
328	328
329	329	SECTION 6. AND BE IT FURTHER ENACTED, That, except as provided in Section 32
330	330	5 of this Act, this Act shall take effect July 1, 2025. 33
331	331