Maryland 2024 Regular Session

Maryland Senate Bill SB990 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	sb0990
6	6
7	7	SENATE BILL 990
8	8	J5, J1, J4 4lr3118
9	9	CF 4lr3119
10	10	By: Senator Lam
11	11	Introduced and read first time: February 2, 2024
12	12	Assigned to: Finance
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 Ins urance – Step Therapy, 2
19	19	Fail–First Protocols, and Prior Authorization – Prescription Drugs to Treat 3
20	20	Serious 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; and generally relating to health insurance and coverage of 9
27	27	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 15–155 13
32	32	Annotated Code of Maryland 14
33	33	(2023 Replacement Volume) 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 2023 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 2023 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 SENATE BILL 990
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	15–155. 5
60	60
61	61	BEGINNING JULY 1, 2024, THE PROGRAM MAY NOT APPLY A PRIOR 6
62	62	AUTHORIZATION REQUIR EMENT, FAIL–FIRST PROTOCOL, OR STEP THERAPY 7
63	63	PROTOCOL FOR A PRESCRIPTION D RUG USED TO TREAT AN ENROLLEE’S DIAGNOSIS 8
64	64	OF: 9
65	65
66	66	(1) BIPOLAR DISORDER; 10
67	67
68	68	(2) SCHIZOPHRENIA ; 11
69	69
70	70	(3) MAJOR DEPRESSION; 12
71	71
72	72	(4) POST–TRAUMATIC STRESS DIS ORDER; OR 13
73	73
74	74	(5) A MEDICATION–INDUCED MOVEMENT DIS ORDER ASSOCIATED 14
75	75	WITH THE TREATMENT O F A SERIOUS MENTAL I LLNESS. 15
76	76
77	77	SECTION 2. AND BE IT FURTHER ENACTED, That the Laws of Maryland read 16
78	78	as follows: 17
79	79
80	80	Article – Insurance 18
81	81
82	82	15–142. 19
83	83
84	84	(a) (1) In this section the following words have the meanings indicated. 20
85	85
86	86	(2) “Step therapy drug” means a prescription drug or sequence of 21
87	87	prescription drugs required to be used under a step therapy or fail–first protocol. 22
88	88
89	89	(3) “Step therapy exception request” means a request to override a step 23
90	90	therapy or fail–first protocol. 24
91	91
92	92	(4) (i) “Step therapy or fail–first protocol” means a protocol established 25
93	93	by an insurer, a nonprofit health service plan, or a health maintenance organization that 26
94	94	requires a prescription drug or sequence of prescription drugs to be used by an insured or 27 SENATE BILL 990 3
95	95
96	96
97	97	an enrollee before a prescription drug ordered by a prescriber for the insured or the enrollee 1
98	98	is covered. 2
99	99
100	100	(ii) “Step therapy or fail–first protocol” includes a protocol that 3
101	101	meets the definition under subparagraph (i) of this paragraph regardless of the name, label, 4
102	102	or terminology used by the insurer, nonprofit health service plan, or health maintenance 5
103	103	organization to identify the protocol. 6
104	104
105	105	(5) “Supporting medical information” means: 7
106	106
107	107	(i) a paid claim from an entity subject to this section for an insured 8
108	108	or an enrollee; 9
109	109
110	110	(ii) a pharmacy record that documents that a prescription has been 10
111	111	filled and delivered to an insured or an enrollee, or a representative of an insured or an 11
112	112	enrollee; or 12
113	113
114	114	(iii) other information mutually agreed on by an entity subject to this 13
115	115	section and the prescriber of an insured or an enrollee. 14
116	116
117	117	(b) (1) This section applies to: 15
118	118
119	119	(i) insurers and nonprofit health service plans that provide hospital, 16
120	120	medical, or surgical benefits to individuals or groups on an expense–incurred basis under 17
121	121	health insurance policies or contracts that are issued or delivered in the State; and 18
122	122
123	123	(ii) health maintenance organizations that provide hospital, 19
124	124	medical, or surgical benefits to individuals or groups under contracts that are issued or 20
125	125	delivered in the State. 21
126	126
127	127	(2) An insurer, a nonprofit health service plan, or a health maintenance 22
128	128	organization that provides coverage for prescription drugs through a pharmacy benefits 23
129	129	manager is subject to the requirements of this section. 24
130	130
131	131	(c) An entity subject to this section may not impose a step therapy or fail–first 25
132	132	protocol on an insured or an enrollee if: 26
133	133
134	134	(1) the step therapy drug has not been approved by the U.S. Food and Drug 27
135	135	Administration for the medical condition being treated; or 28
136	136
137	137	(2) a prescriber provides supporting medical information to the entity that 29
138	138	a prescription drug covered by the entity: 30
139	139
140	140	(i) was ordered by a prescriber for the insured or enrollee within the 31
141	141	past 180 days; and 32
142	142	4 SENATE BILL 990
143	143
144	144
145	145	(ii) based on the professional judgment of the prescriber, was 1
146	146	effective in treating the insured’s or enrollee’s disease or medical condition. 2
147	147
148	148	(d) Subsection (c) of this section may not be construed to require coverage for a 3
149	149	prescription drug that is not: 4
150	150
151	151	(1) covered by the policy or contract of an entity subject to this section; or 5
152	152
153	153	(2) otherwise required by law to be covered. 6
154	154
155	155	(e) An entity subject to this section may not impose a step therapy or fail–first 7
156	156	protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and 8
157	157	Drug Administration if: 9
158	158
159	159	(1) (I) the prescription drug is used to treat the insured’s or enrollee’s 10
160	160	stage four advanced metastatic cancer; and 11
161	161
162	162	[(2)] (II) use of the prescription drug is: 12
163	163
164	164	[(i)] 1. consistent with the U.S. Food and Drug 13
165	165	Administration–approved indication or the National Comprehensive Cancer Network 14
166	166	Drugs & Biologics Compendium indication for the treatment of stage four advanced 15
167	167	metastatic cancer; and 16
168	168
169	169	[(ii)] 2. supported by peer–reviewed medical literature; OR 17
170	170
171	171	(2) THE PRESCRIPTION DRUG IS USED TO TREAT THE INSURED’S OR 18
172	172	ENROLLEE’S DIAGNOSIS OF: 19
173	173
174	174	(I) BIPOLAR DISORDER ; 20
175	175
176	176	(II) SCHIZOPHRENIA ; 21
177	177
178	178	(III) MAJOR DEPRESSION ; 22
179	179
180	180	(IV) POST–TRAUMATIC STRESS DIS ORDER; OR 23
181	181
182	182	(V) A MEDICATION –INDUCED MOVEMENT DIS ORDER 24
183	183	ASSOCIATED WITH THE TREATMENT OF A SERIO US MENTAL ILLNESS. 25
184	184
185	185	(f) (1) An entity subject to this section shall establish a process for requesting 26
186	186	an exception to a step therapy or fail–first protocol that is: 27
187	187	SENATE BILL 990 5
188	188
189	189
190	190	(i) clearly described, including the specific information and 1
191	191	documentation, if needed, that must be submitted by the prescriber to be considered a 2
192	192	complete step therapy exception request; 3
193	193
194	194	(ii) easily accessible to the prescriber; and 4
195	195
196	196	(iii) posted on the entity’s website. 5
197	197
198	198	(2) A step therapy exception request shall be granted if, based on the 6
199	199	professional judgment of the prescriber and any information and documentation required 7
200	200	under paragraph (1)(i) of this subsection: 8
201	201
202	202	(i) the step therapy drug is contraindicated or will likely cause an 9
203	203	adverse reaction to the insured or enrollee; 10
204	204
205	205	(ii) the step therapy drug is expected to be ineffective based on the 11
206	206	known clinical characteristics of the insured or enrollee and the known characteristics of 12
207	207	the prescription drug regimen; 13
208	208
209	209	(iii) the insured or enrollee is stable on a prescription drug prescribed 14
210	210	for the medical condition under consideration while covered under the policy or contract of 15
211	211	the entity or under a previous source of coverage; or 16
212	212
213	213	(iv) while covered under the policy or contract of the entity or a 17
214	214	previous source of coverage, the insured or enrollee has tried a prescription drug that: 18
215	215
216	216	1. is in the same pharmacologic class or has the same 19
217	217	mechanism of action as the step therapy drug; and 20
218	218
219	219	2. was discontinued by the prescriber due to lack of efficacy 21
220	220	or effectiveness, diminished effect, or an adverse event. 22
221	221
222	222	(3) On granting a step therapy exception request, an entity subject to this 23
223	223	section shall authorize coverage for the prescription drug ordered by the prescriber for an 24
224	224	insured or enrollee. 25
225	225
226	226	(4) An enrollee or insured may appeal a step therapy exception request 26
227	227	denial in accordance with Subtitle 10A or Subtitle 10B of this title. 27
228	228
229	229	(5) This subsection may not be construed to: 28
230	230
231	231	(i) prevent: 29
232	232
233	233	1. an entity subject to this section from requiring an insured 30
234	234	or enrollee to try an AB–rated generic equivalent or interchangeable biological product 31
235	235	before providing coverage for the equivalent branded prescription drug; or 32
236	236	6 SENATE BILL 990
237	237
238	238
239	239	2. a health care provider from prescribing a prescription 1
240	240	drug that is determined to be medically appropriate; or 2
241	241
242	242	(ii) require an entity subject to this section to provide coverage for a 3
243	243	prescription drug that is not covered by a policy or contract of the entity. 4
244	244
245	245	(6) An entity subject to this section may use an existing step therapy 5
246	246	exception process that satisfies the requirements under this subsection. 6
247	247
248	248	15–851.1. 7
249	249
250	250	(A) (1) THIS SECTION APPLIES TO: 8
251	251
252	252	(I) INSURERS AND NONPROF IT HEALTH SERVICE PL ANS THAT 9
253	253	PROVIDE COVERAGE FOR PRESCRI PTION DRUGS UNDER IN DIVIDUAL, GROUP, OR 10
254	254	BLANKET HEALTH INSURANCE POL ICIES OR CONTRACTS T HAT ARE ISSUED OR 11
255	255	DELIVERED IN THE STATE; AND 12
256	256
257	257	(II) HEALTH MAINTENANCE O RGANIZATIONS THAT PR OVIDE 13
258	258	COVERAGE FOR PRESCRI PTION DRUGS UNDER IN DIVIDUAL OR GROUP CONTRACTS 14
259	259	THAT ARE ISSUED OR D ELIVERED IN THE STATE. 15
260	260
261	261	(2) AN INSURER, A NONPROFIT HEALTH S ERVICE PLAN, OR A HEALTH 16
262	262	MAINTENANCE ORGANIZA TION THAT PROVIDES C OVERAGE FOR PRESCRIP TION 17
263	263	DRUGS THROUGH A PHAR MACY BENEFITS MANAGE R IS SUBJECT TO THE 18
264	264	REQUIREMENTS OF THIS SECTION. 19
265	265
266	266	(B) AN ENTITY SUBJECT TO THIS SECTION MAY NOT APPLY A PRIO R 20
267	267	AUTHORIZATION REQUIR EMENT FOR A PRESCRIP TION DRUG USED TO TREAT THE 21
268	268	INSURED’S OR ENROLLEE ’S DIAGNOSIS OF: 22
269	269
270	270	(1) BIPOLAR DISORDER ; 23
271	271
272	272	(2) SCHIZOPHRENIA ; 24
273	273
274	274	(3) MAJOR DEPRESSION ; 25
275	275
276	276	(4) POST–TRAUMATIC STRESS DIS ORDER; OR 26
277	277
278	278	(5) A MEDICATION–INDUCED MOVEMENT DIS ORDER ASSOCIATED 27
279	279	WITH THE TREATMENT O F A SERIOUS MENTAL I LLNESS. 28
280	280
281	281	SECTION 3. AND BE IT FURTHER ENACTED, That: 29
282	282	SENATE BILL 990 7
283	283
284	284
285	285	(a) On or before January 31, 2026, and each January 1 thereafter through 2030, 1
286	286	the Maryland Department of Health shall report to the Department of Legislative Services 2
287	287	on any cost increase to the Maryland Medical Assistance Program from the immediately 3
288	288	preceding fiscal year that results from the implementation of Section 1 of this Act. 4
289	289
290	290	(b) On or before April 30 of the year in which a report is submitted under 5
291	291	subsection (a) of this section, the Department of Legislative Services shall determine, based 6
292	292	on the report, whether the implementation of Section 1 of this Act resulted in a cost increase 7
293	293	to the Maryland Medical Assistance Program of more than $2,000,000 from the 8
294	294	immediately preceding fiscal year. 9
295	295
296	296	(c) If the Department of Legislative Services determines that the implementation 10
297	297	of Section 1 of this Act resulted in a cost increase to the Maryland Medical Assistance 11
298	298	Program of more than $2,000,000 from the immediately preceding fiscal year, with no 12
299	299	further action required by the General Assembly, at the end of April 30 of the year the 13
300	300	determination is made, Section 1 of this Act shall be abrogated and of no further force and 14
301	301	effect. 15
302	302
303	303	SECTION 4. AND BE IT FURTHER ENACTED, That Section 2 of this Act shall 16
304	304	apply to all policies, contracts, and health benefit plans issued, delivered, or renewed in the 17
305	305	State on or after January 1, 2025. 18
306	306
307	307	SECTION 5. AND BE IT FURTHER ENACTED, That Section 2 of this Act shall take 19
308	308	effect January 1, 2025. 20
309	309
310	310	SECTION 6. AND BE IT FURTHER ENACTED, That, except as provided in Section 21
311	311	5 of this Act, this Act shall take effect July 1, 2024. 22
312	312