Maryland 2025 Regular Session

Maryland House Bill HB382 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	hb0382
6	6
7	7	HOUSE BILL 382
8	8	J5, J4, J1 5lr2479
9	9	CF SB 111
10	10	By: Delegates S. Johnson, A. Johnson, Kerr, McComas, and Taveras
11	11	Introduced and read first time: January 16, 2025
12	12	Assigned to: Health and Government Operations
13	13
14	14	A BILL ENTITLED
15	15
16	16	AN ACT concerning 1
17	17
18	18	Maryland Medical Assistance Program and Health Insurance – Step Therapy, 2
19	19	Fail–First Protocols, and Prior Authorization – Prescription to Treat Serious 3
20	20	Mental Illness 4
21	21
22	22	FOR the purpose of prohibiting the Maryland Medical Assistance Program and certain 5
23	23	insurers, nonprofit health service plans, health maintenance organizations, and 6
24	24	managed care organizations from applying a prior authorization requirement, step 7
25	25	therapy protocol, or fail–first protocol for prescription drugs used to treat certain 8
26	26	mental illnesses of certain insureds and enrollees; and generally relating to coverage 9
27	27	of prescription drugs to treat serious mental illness. 10
28	28
29	29	BY adding to 11
30	30	Article – Health – General 12
31	31	Section 15–102.3(m) and 15–157 13
32	32	Annotated Code of Maryland 14
33	33	(2023 Replacement Volume and 2024 Supplement) 15
34	34
35	35	BY repealing and reenacting, with amendments, 16
36	36	Article – Insurance 17
37	37	Section 15–142 18
38	38	Annotated Code of Maryland 19
39	39	(2017 Replacement Volume and 2024 Supplement) 20
40	40
41	41	BY adding to 21
42	42	Article – Insurance 22
43	43	Section 15–851.1 23
44	44	Annotated Code of Maryland 24
45	45	(2017 Replacement Volume and 2024 Supplement) 25
46	46
47	47	SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 26
48	48	That the Laws of Maryland read as follows: 27 2 HOUSE BILL 382
49	49
50	50
51	51
52	52	Article – Health – General 1
53	53
54	54	15–102.3. 2
55	55
56	56	(M) THE PROVISIONS OF §§ 15–142(E)(2) AND 15–851.1 OF THE INSURANCE 3
57	57	ARTICLE APPLY TO MANA GED CARE ORGANIZATIO NS. 4
58	58
59	59	15–157. 5
60	60
61	61	(A) IN THIS SECTION, “STEP THERAPY OR FAIL –FIRST PROTOCOL ” HAS THE 6
62	62	MEANING STATED IN § 15–142 OF THE INSURANCE ARTICLE. 7
63	63
64	64	(B) EXCEPT AS REQUIRED UN DER 42 U.S.C. § 1396A, BEGINNING JULY 1, 8
65	65	2025, THE PROGRAM MAY NOT APPLY A PRIOR AUTHORIZATIO N REQUIREMENT FOR 9
66	66	A PRESCRIPTION DRUG USED TO TREAT AN ADU LT ENROLLEE’S DIAGNOSIS OF: 10
67	67
68	68	(1) BIPOLAR DISORDER ; 11
69	69
70	70	(2) SCHIZOPHRENIA ; 12
71	71
72	72	(3) MAJOR DEPRESSION ; 13
73	73
74	74	(4) POST–TRAUMATIC STRESS DIS ORDER; OR 14
75	75
76	76	(5) A MEDICATION–INDUCED MOVEMENT DIS ORDER ASSOCIATED 15
77	77	WITH THE TREATMENT O F A SERIOUS MENTAL I LLNESS. 16
78	78
79	79	(C) BEGINNING JULY 1, 2025, THE PROGRAM MAY NOT APPLY A STEP 17
80	80	THERAPY OR FAIL –FIRST PROTOCOL FOR A PRESCRIPTION DRUG US ED TO TREAT AN 18
81	81	ENROLLEE’S DIAGNOSIS OF: 19
82	82
83	83	(1) BIPOLAR DISORDER ; 20
84	84
85	85	(2) SCHIZOPHRENIA ; 21
86	86
87	87	(3) MAJOR DEPRESSION ; 22
88	88
89	89	(4) POST–TRAUMATIC STRESS DIS ORDER; OR 23
90	90
91	91	(5) A MEDICATION–INDUCED MOVEMENT DIS ORDER ASSOCIATED 24
92	92	WITH THE TREATMENT O F A SERIOUS MENTAL I LLNESS. 25
93	93	HOUSE BILL 382 3
94	94
95	95
96	96	SECTION 2. AND BE IT FURTHER ENACTED, That the Laws of Maryland read 1
97	97	as follows: 2
98	98
99	99	Article – Insurance 3
100	100
101	101	15–142. 4
102	102
103	103	(a) (1) In this section the following words have the meanings indicated. 5
104	104
105	105	(2) “Step therapy drug” means a prescription drug or sequence of 6
106	106	prescription drugs required to be used under a step therapy or fail–first protocol. 7
107	107
108	108	(3) “Step therapy exception request” means a request to override a step 8
109	109	therapy or fail–first protocol. 9
110	110
111	111	(4) (i) “Step therapy or fail–first protocol” means a protocol established 10
112	112	by an insurer, a nonprofit health service plan, or a health maintenance organization that 11
113	113	requires a prescription drug or sequence of prescription drugs to be used by an insured or 12
114	114	an enrollee before a prescription drug ordered by a prescriber for the insured or the enrollee 13
115	115	is covered. 14
116	116
117	117	(ii) “Step therapy or fail–first protocol” includes a protocol that 15
118	118	meets the definition under subparagraph (i) of this paragraph regardless of the name, label, 16
119	119	or terminology used by the insurer, nonprofit health service plan, or health maintenance 17
120	120	organization to identify the protocol. 18
121	121
122	122	(5) “Supporting medical information” means: 19
123	123
124	124	(i) a paid claim from an entity subject to this section for an insured 20
125	125	or an enrollee; 21
126	126
127	127	(ii) a pharmacy record that documents that a prescription has been 22
128	128	filled and delivered to an insured or an enrollee, or a representative of an insured or an 23
129	129	enrollee; or 24
130	130
131	131	(iii) other information mutually agreed on by an entity subject to this 25
132	132	section and the prescriber of an insured or an enrollee. 26
133	133
134	134	(b) (1) This section applies to: 27
135	135
136	136	(i) insurers and nonprofit health service plans that provide hospital, 28
137	137	medical, or surgical benefits to individuals or groups on an expense–incurred basis under 29
138	138	health insurance policies or contracts that are issued or delivered in the State; and 30
139	139
140	140	(ii) health maintenance organizations that provide hospital, 31
141	141	medical, or surgical benefits to individuals or groups under contracts that are issued or 32
142	142	delivered in the State. 33 4 HOUSE BILL 382
143	143
144	144
145	145
146	146	(2) An insurer, a nonprofit health service plan, or a health maintenance 1
147	147	organization that provides coverage for prescription drugs through a pharmacy benefits 2
148	148	manager is subject to the requirements of this section. 3
149	149
150	150	(c) An entity subject to this section may not impose a step therapy or fail–first 4
151	151	protocol on an insured or an enrollee if: 5
152	152
153	153	(1) the step therapy drug has not been approved by the U.S. Food and Drug 6
154	154	Administration for the medical condition being treated; or 7
155	155
156	156	(2) a prescriber provides supporting medical information to the entity that 8
157	157	a prescription drug covered by the entity: 9
158	158
159	159	(i) was ordered by a prescriber for the insured or enrollee within the 10
160	160	past 180 days; and 11
161	161
162	162	(ii) based on the professional judgment of the prescriber, was 12
163	163	effective in treating the insured’s or enrollee’s disease or medical condition. 13
164	164
165	165	(d) Subsection (c) of this section may not be construed to require coverage for a 14
166	166	prescription drug that is not: 15
167	167
168	168	(1) covered by the policy or contract of an entity subject to this section; or 16
169	169
170	170	(2) otherwise required by law to be covered. 17
171	171
172	172	(e) An entity subject to this section may not impose a step therapy or fail–first 18
173	173	protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and 19
174	174	Drug Administration if: 20
175	175
176	176	(1) (I) the prescription drug is used to treat the insured’s or enrollee’s 21
177	177	stage four advanced metastatic cancer; and 22
178	178
179	179	[(2)] (II) use of the prescription drug is: 23
180	180
181	181	[(i)] 1. consistent with the U.S. Food and Drug 24
182	182	Administration–approved indication or the National Comprehensive Cancer Network 25
183	183	Drugs & Biologics Compendium indication for the treatment of stage four advanced 26
184	184	metastatic cancer; and 27
185	185
186	186	[(ii)] 2. supported by peer–reviewed medical literature; OR 28
187	187
188	188	(2) THE PRESCRIPTION DRU G IS USED TO TREAT T HE INSURED’S OR 29
189	189	ENROLLEE’S DIAGNOSIS OF: 30
190	190	HOUSE BILL 382 5
191	191
192	192
193	193	(I) BIPOLAR DISORDER ; 1
194	194
195	195	(II) SCHIZOPHRENIA ; 2
196	196
197	197	(III) MAJOR DEPRESSION ; 3
198	198
199	199	(IV) POST–TRAUMATIC STRESS DIS ORDER; OR 4
200	200
201	201	(V) A MEDI CATION–INDUCED MOVEMENT DIS ORDER 5
202	202	ASSOCIATED WITH THE TREATMENT OF A SERIO US MENTAL ILLNESS . 6
203	203
204	204	(f) (1) An entity subject to this section shall establish a process for requesting 7
205	205	an exception to a step therapy or fail–first protocol that is: 8
206	206
207	207	(i) clearly described, including the specific information and 9
208	208	documentation, if needed, that must be submitted by the prescriber to be considered a 10
209	209	complete step therapy exception request; 11
210	210
211	211	(ii) easily accessible to the prescriber; and 12
212	212
213	213	(iii) posted on the entity’s website. 13
214	214
215	215	(2) A step therapy exception request shall be granted if, based on the 14
216	216	professional judgment of the prescriber and any information and documentation required 15
217	217	under paragraph (1)(i) of this subsection: 16
218	218
219	219	(i) the step therapy drug is contraindicated or will likely cause an 17
220	220	adverse reaction to the insured or enrollee; 18
221	221
222	222	(ii) the step therapy drug is expected to be ineffective based on the 19
223	223	known clinical characteristics of the insured or enrollee and the known characteristics of 20
224	224	the prescription drug regimen; 21
225	225
226	226	(iii) the insured or enrollee is stable on a prescription drug prescribed 22
227	227	for the medical condition under consideration while covered under the policy or contract of 23
228	228	the entity or under a previous source of coverage; or 24
229	229
230	230	(iv) while covered under the policy or contract of the entity or a 25
231	231	previous source of coverage, the insured or enrollee has tried a prescription drug that: 26
232	232
233	233	1. is in the same pharmacologic class or has the same 27
234	234	mechanism of action as the step therapy drug; and 28
235	235
236	236	2. was discontinued by the prescriber due to lack of efficacy 29
237	237	or effectiveness, diminished effect, or an adverse event. 30
238	238	6 HOUSE BILL 382
239	239
240	240
241	241	(3) On granting a step therapy exception request, an entity subject to this 1
242	242	section shall authorize coverage for the prescription drug ordered by the prescriber for an 2
243	243	insured or enrollee. 3
244	244
245	245	(4) An enrollee or insured may appeal a step therapy exception request 4
246	246	denial in accordance with Subtitle 10A or Subtitle 10B of this title. 5
247	247
248	248	(5) This subsection may not be construed to: 6
249	249
250	250	(i) prevent: 7
251	251
252	252	1. an entity subject to this section from requiring an insured 8
253	253	or enrollee to try an AB–rated generic equivalent or interchangeable biological product 9
254	254	before providing coverage for the equivalent branded prescription drug; or 10
255	255
256	256	2. a health care provider from prescribing a prescription 11
257	257	drug that is determined to be medically appropriate; or 12
258	258
259	259	(ii) require an entity subject to this section to provide coverage for a 13
260	260	prescription drug that is not covered by a policy or contract of the entity. 14
261	261
262	262	(6) An entity subject to this section may use an existing step therapy 15
263	263	exception process that satisfies the requirements under this subsection. 16
264	264
265	265	15–851.1. 17
266	266
267	267	(A) (1) THIS SECTION APPLIES TO: 18
268	268
269	269	(I) INSURERS AND NONPROF IT HEALTH SERVICE PL ANS THAT 19
270	270	PROVIDE COVERAGE FOR PRESCRIPTION DRUGS U NDER INDIVIDUAL , GROUP, OR 20
271	271	BLANKET HEALTH INSUR ANCE POLICIES OR CON TRACTS THAT ARE ISSU ED OR 21
272	272	DELIVERED IN THE STATE; AND 22
273	273
274	274	(II) HEALTH MAINTENANCE O RGANIZATIONS THAT PR OVIDE 23
275	275	COVERAGE FOR PRESCRI PTION DRUGS U NDER INDIVIDUAL OR G ROUP CONTRACTS 24
276	276	THAT ARE ISSUED OR D ELIVERED IN THE STATE. 25
277	277
278	278	(2) AN INSURER, A NONPROFIT HEALTH S ERVICE PLAN, OR A HEALTH 26
279	279	MAINTENANCE ORGANIZA TION THAT PROVIDES C OVERAGE FOR PRESCRIP TION 27
280	280	DRUGS THROUGH A PHAR MACY BENEFITS MANAGE R IS SUBJ ECT TO THE 28
281	281	REQUIREMENTS OF THIS SECTION. 29
282	282
283	283	(B) EXCEPT AS REQUIRED UN DER 42 U.S.C. § 1396A, AN ENTITY SUBJECT 30
284	284	TO THIS SECTION MAY NOT APPLY A PRIOR AU THORIZATION REQUIREM ENT FOR A 31 HOUSE BILL 382 7
285	285
286	286
287	287	PRESCRIPTION DRUG US ED TO TREAT AN ADULT INSURED’S OR ENROLLEE ’S 1
288	288	DIAGNOSIS OF: 2
289	289
290	290	(1) BIPOLAR DISORDER ; 3
291	291
292	292	(2) SCHIZOPHRENIA ; 4
293	293
294	294	(3) MAJOR DEPRESSION ; 5
295	295
296	296	(4) POST–TRAUMATIC STRESS DIS ORDER; OR 6
297	297
298	298	(5) A MEDICATION –INDUCED MOVEMENT DIS ORDER ASSOCIATED 7
299	299	WITH THE TREATMENT O F A SERIOUS MENTAL I LLNESS. 8
300	300
301	301	SECTION 3. AND BE IT FURTHER ENAC TED, That: 9
302	302
303	303	(a) On or before January 31, 2027, and each January 1 thereafter through 2031, 10
304	304	the Maryland Department of Health shall report to the Department of Legislative Services 11
305	305	on any cost increase to the Maryland Medical Assistance Program from the immediately 12
306	306	preceding fiscal year that results from the implementation of Section 1 of this Act. 13
307	307
308	308	(b) On or before April 30 of the year in which a report is submitted under 14
309	309	subsection (a) of this section, the Department of Legislative Services shall determine, based 15
310	310	on the report, whether the implementation of Section 1 of this Act resulted in a cost increase 16
311	311	to the Maryland Medical Assistance Program of more than $2,000,000 from the 17
312	312	immediately preceding fiscal year. 18
313	313
314	314	(c) If the Department of Legislative Services determines that the implementation 19
315	315	of Section 1 of this Act resulted in a cost increase to the Maryland Medical Assistance 20
316	316	Program of more than $2,000,000 from the immediately preceding fiscal year, with no 21
317	317	further action required by the General Assembly, at the end of April 30 of the year the 22
318	318	determination is made, Section 1 of this Act shall be abrogated and of no further force and 23
319	319	effect. 24
320	320
321	321	SECTION 4. AND BE IT FURTHER ENACTED, That Section 2 of this Act shall 25
322	322	apply to all policies, contracts, and health benefit plans issued, delivered, or renewed in the 26
323	323	State on or after January 1, 2026. 27
324	324
325	325	SECTION 5. AND BE IT FURTHER ENACTED, That Section 2 of this Act shall take 28
326	326	effect January 1, 2026. 29
327	327
328	328	SECTION 6. AND BE IT FURTHER ENACTED, That, except as provided in Section 30
329	329	5 of this Act, this Act shall take effect July 1, 2025. 31
330	330