Texas 2017 - 85th Regular

Texas House Bill HB1464 Compare Versions

Version 1 (Old)

Version 2 (New)

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1	1	85R23121 PMO-F
2	2	By: Bonnen of Galveston, Parker, H.B. No. 1464
3	3	Thompson of Harris, Bernal, Villalba,
4	4	et al.
5	5	Substitute the following for H.B.
6	6
7	7
8	8	A BILL TO BE ENTITLED
9	9	AN ACT
10	10	relating to step therapy protocols required by a health benefit
11	11	plan in connection with prescription drug coverage.
12	12	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
13	13	SECTION 1. Section 1369.051, Insurance Code, is amended by
14	14	amending Subdivision (1) and adding Subdivisions (1-a), (1-b), and
15	15	(5) to read as follows:
16	16	(1) "Clinical practice guideline" means a statement
17	17	systematically developed by a multidisciplinary panel of experts
18	18	composed of physicians and, as necessary, other health care
19	19	providers to assist a patient or health care provider in making a
20	20	decision about appropriate health care for a specific clinical
21	21	circumstance or condition.
22	22	(1-a) "Clinical review criteria" means the written
23	23	screening procedures, decision abstracts, clinical protocols, and
24	24	clinical practice guidelines used by a health benefit plan issuer,
25	25	utilization review organization, or independent review
26	26	organization to determine the medical necessity and
27	27	appropriateness or the experimental or investigational nature of a
28	28	health care service or prescription drug.
29	29	(1-b) "Drug formulary" means a list of drugs:
30	30	(A) for which a health benefit plan provides
31	31	coverage;
32	32	(B) for which a health benefit plan issuer
33	33	approves payment; or
34	34	(C) that a health benefit plan issuer encourages
35	35	or offers incentives for physicians to prescribe.
36	36	(5) "Step therapy protocol" means a protocol that
37	37	requires an enrollee to use a prescription drug or sequence of
38	38	prescription drugs other than the drug that the enrollee's
39	39	physician recommends for the enrollee's treatment before the health
40	40	benefit plan provides coverage for the recommended drug.
41	41	SECTION 2. Subchapter B, Chapter 1369, Insurance Code, is
42	42	amended by adding Sections 1369.0545 and 1369.0546 to read as
43	43	follows:
44	44	Sec. 1369.0545. STEP THERAPY PROTOCOLS. (a) A health
45	45	benefit plan issuer that requires a step therapy protocol before
46	46	providing coverage for a prescription drug must establish,
47	47	implement, and administer the step therapy protocol in accordance
48	48	with clinical review criteria readily available to the health care
49	49	industry. The health benefit plan issuer shall take into account
50	50	the needs of atypical patient populations and diagnoses in
51	51	establishing the clinical review criteria. The clinical review
52	52	criteria:
53	53	(1) must consider generally accepted clinical
54	54	practice guidelines that are:
55	55	(A) developed and endorsed by a
56	56	multidisciplinary panel of experts described by Subsection (b);
57	57	(B) based on high quality studies, research, and
58	58	medical practice;
59	59	(C) created by an explicit and transparent
60	60	process that:
61	61	(i) minimizes bias and conflicts of
62	62	interest;
63	63	(ii) explains the relationship between
64	64	treatment options and outcomes;
65	65	(iii) rates the quality of the evidence
66	66	supporting the recommendations; and
67	67	(iv) considers relevant patient subgroups
68	68	and preferences; and
69	69	(D) updated at appropriate intervals after a
70	70	review of new evidence, research, and treatments; or
71	71	(2) if clinical practice guidelines described by
72	72	Subdivision (1) are not reasonably available, may be based on
73	73	peer-reviewed publications developed by independent experts, which
74	74	may include physicians, with expertise applicable to the relevant
75	75	health condition.
76	76	(b) A multidisciplinary panel of experts composed of
77	77	physicians and, as necessary, other health care providers that
78	78	develops and endorses clinical practice guidelines under
79	79	Subsection (a)(1) must manage conflicts of interest by:
80	80	(1) requiring each member of the panel's writing or
81	81	review group to:
82	82	(A) disclose any potential conflict of interest,
83	83	including a conflict of interest involving an insurer, health
84	84	benefit plan issuer, or pharmaceutical manufacturer; and
85	85	(B) recuse himself or herself in any situation in
86	86	which the member has a conflict of interest;
87	87	(2) using a methodologist to work with writing groups
88	88	to provide objectivity in data analysis and the ranking of evidence
89	89	by preparing evidence tables and facilitating consensus; and
90	90	(3) offering an opportunity for public review and
91	91	comment.
92	92	(c) Subsection (b) does not apply to a panel or committee of
93	93	experts, including a pharmacy and therapeutics committee,
94	94	established by a health benefit plan issuer or a pharmacy benefit
95	95	manager that advises the health benefit plan issuer or pharmacy
96	96	benefit manager regarding drugs or formularies.
97	97	Sec. 1369.0546. STEP THERAPY PROTOCOL EXCEPTION REQUESTS.
98	98	(a) A health benefit plan issuer shall establish a process in a
99	99	user-friendly format that is readily accessible to a patient and
100	100	prescribing provider, in the health benefit plan's formulary
101	101	document and otherwise, through which an exception request under
102	102	this section may be submitted by the provider.
103	103	(b) A prescribing provider on behalf of a patient may submit
104	104	to the patient's health benefit plan issuer a written request for an
105	105	exception to a step therapy protocol required by the patient's
106	106	health benefit plan. The provider shall submit the request on the
107	107	standard form prescribed by the commissioner under Section
108	108	1369.304.
109	109	(c) A health benefit plan issuer shall grant a written
110	110	request under Subsection (b) if the request includes the
111	111	prescribing provider's written statement, with supporting
112	112	documentation, stating that:
113	113	(1) the drug required under the step therapy protocol:
114	114	(A) is contraindicated;
115	115	(B) will likely cause an adverse reaction in or
116	116	physical or mental harm to the patient; or
117	117	(C) is expected to be ineffective based on the
118	118	known clinical characteristics of the patient and the known
119	119	characteristics of the prescription drug regimen;
120	120	(2) the patient previously discontinued taking the
121	121	drug required under the step therapy protocol, or another
122	122	prescription drug in the same pharmacologic class or with the same
123	123	mechanism of action as the required drug, while under the health
124	124	benefit plan currently in force or while covered under another
125	125	health benefit plan because the drug was not effective or had a
126	126	diminished effect or because of an adverse event;
127	127	(3) the drug required under the step therapy protocol
128	128	is not in the best interest of the patient, based on clinical
129	129	appropriateness, because the patient's use of the drug is expected
130	130	to:
131	131	(A) cause a significant barrier to the patient's
132	132	adherence to or compliance with the patient's plan of care;
133	133	(B) worsen a comorbid condition of the patient;
134	134	or
135	135	(C) decrease the patient's ability to achieve or
136	136	maintain reasonable functional ability in performing daily
137	137	activities; or
138	138	(4)(A) the drug that is subject to the step therapy
139	139	protocol was prescribed for the patient's condition;
140	140	(B) the patient:
141	141	(i) received benefits for the drug under
142	142	the health benefit plan currently in force or a previous health
143	143	benefit plan; and
144	144	(ii) is stable on the drug; and
145	145	(C) the change in the patient's prescription drug
146	146	regimen required by the step therapy protocol is expected to be
147	147	ineffective or cause harm to the patient based on the known clinical
148	148	characteristics of the patient and the known characteristics of the
149	149	required prescription drug regimen.
150	150	(d) Except as provided by Subsection (e), if a health
151	151	benefit plan issuer does not deny an exception request described by
152	152	Subsection (c) before 72 hours after the health benefit plan issuer
153	153	receives the request, the request is considered granted.
154	154	(e) If an exception request described by Subsection (c) also
155	155	states that the prescribing provider reasonably believes that
156	156	denial of the request makes the death of or serious harm to the
157	157	patient probable, the request is considered granted if the health
158	158	benefit plan issuer does not deny the request before 24 hours after
159	159	the health benefit plan issuer receives the request.
160	160	(f) The denial of an exception request under this section is
161	161	an adverse determination for purposes of Section 4201.002 and is
162	162	subject to appeal under Subchapters H and I, Chapter 4201.
163	163	SECTION 3. Section 4201.357, Insurance Code, is amended by
164	164	adding Subsection (a-2) to read as follows:
165	165	(a-2) An adverse determination under Section 1369.0546 is
166	166	entitled to an expedited appeal. The physician or, if appropriate,
167	167	other health care provider deciding the appeal must consider
168	168	atypical diagnoses and the needs of atypical patient populations.
169	169	SECTION 4. Section 4202.003, Insurance Code, is amended to
170	170	read as follows:
171	171	Sec. 4202.003. REQUIREMENTS REGARDING TIMELINESS OF
172	172	DETERMINATION. The standards adopted under Section 4202.002 must
173	173	require each independent review organization to make the
174	174	organization's determination:
175	175	(1) for a life-threatening condition as defined by
176	176	Section 4201.002, [or] the provision of prescription drugs or
177	177	intravenous infusions for which the patient is receiving benefits
178	178	under the health insurance policy, or a review of a step therapy
179	179	protocol exception request under Section 1369.0546, not later than
180	180	the earlier of the third day after the date the organization
181	181	receives the information necessary to make the determination or,
182	182	with respect to:
183	183	(A) a review of a health care service provided to
184	184	a person with a life-threatening condition eligible for workers'
185	185	compensation medical benefits, the eighth day after the date the
186	186	organization receives the request that the determination be made;
187	187	or
188	188	(B) a review of a health care service other than a
189	189	service described by Paragraph (A), the third day after the date the
190	190	organization receives the request that the determination be made;
191	191	or
192	192	(2) for a situation other than a situation described
193	193	by Subdivision (1), not later than the earlier of:
194	194	(A) the 15th day after the date the organization
195	195	receives the information necessary to make the determination; or
196	196	(B) the 20th day after the date the organization
197	197	receives the request that the determination be made.
198	198	SECTION 5. The changes in law made by this Act apply only to
199	199	a health benefit plan that is delivered, issued for delivery, or
200	200	renewed on or after January 1, 2018. A health benefit plan
201	201	delivered, issued for delivery, or renewed before January 1, 2018,
202	202	is governed by the law as it existed immediately before the
203	203	effective date of this Act, and that law is continued in effect for
204	204	that purpose.
205	205	SECTION 6. This Act takes effect September 1, 2017.