Texas 2017 - 85th Regular

Texas Senate Bill SB680 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1		-	85R23121 PMO-F
2		-	By: Hancock, et al. S.B. No. 680
3		-	(Bonnen of Galveston, Parker, Thompson of Harris, Bernal,
4		-	Villalba, et al.)
	1	+	S.B. No. 680
5	2
6	3
7		-	A BILL TO BE ENTITLED
8	4		AN ACT
9	5		relating to step therapy protocols required by a health benefit
10	6		plan in connection with prescription drug coverage.
11	7		BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
12	8		SECTION 1. Section 1369.051, Insurance Code, is amended by
13	9		amending Subdivision (1) and adding Subdivisions (1-a), (1-b), and
14	10		(5) to read as follows:
15	11		(1) "Clinical practice guideline" means a statement
16	12		systematically developed by a multidisciplinary panel of experts
17	13		composed of physicians and, as necessary, other health care
18	14		providers to assist a patient or health care provider in making a
19	15		decision about appropriate health care for a specific clinical
20	16		circumstance or condition.
21	17		(1-a) "Clinical review criteria" means the written
22	18		screening procedures, decision abstracts, clinical protocols, and
23	19		clinical practice guidelines used by a health benefit plan issuer,
24	20		utilization review organization, or independent review
25	21		organization to determine the medical necessity and
26	22		appropriateness or the experimental or investigational nature of a
27	23		health care service or prescription drug.
28	24		(1-b) "Drug formulary" means a list of drugs:
29	25		(A) for which a health benefit plan provides
30	26		coverage;
31	27		(B) for which a health benefit plan issuer
32	28		approves payment; or
33	29		(C) that a health benefit plan issuer encourages
34	30		or offers incentives for physicians to prescribe.
35	31		(5) "Step therapy protocol" means a protocol that
36	32		requires an enrollee to use a prescription drug or sequence of
37	33		prescription drugs other than the drug that the enrollee's
38	34		physician recommends for the enrollee's treatment before the health
39	35		benefit plan provides coverage for the recommended drug.
40	36		SECTION 2. Subchapter B, Chapter 1369, Insurance Code, is
41	37		amended by adding Sections 1369.0545 and 1369.0546 to read as
42	38		follows:
43	39		Sec. 1369.0545. STEP THERAPY PROTOCOLS. (a) A health
44	40		benefit plan issuer that requires a step therapy protocol before
45	41		providing coverage for a prescription drug must establish,
46	42		implement, and administer the step therapy protocol in accordance
47	43		with clinical review criteria readily available to the health care
48	44		industry. The health benefit plan issuer shall take into account
49	45		the needs of atypical patient populations and diagnoses in
50	46		establishing the clinical review criteria. The clinical review
51	47		criteria:
52	48		(1) must consider generally accepted clinical
53	49		practice guidelines that are:
54	50		(A) developed and endorsed by a
55	51		multidisciplinary panel of experts described by Subsection (b);
56	52		(B) based on high quality studies, research, and
57	53		medical practice;
58	54		(C) created by an explicit and transparent
59	55		process that:
60	56		(i) minimizes bias and conflicts of
61	57		interest;
62	58		(ii) explains the relationship between
63	59		treatment options and outcomes;
64	60		(iii) rates the quality of the evidence
65	61		supporting the recommendations; and
66	62		(iv) considers relevant patient subgroups
67	63		and preferences; and
68	64		(D) updated at appropriate intervals after a
69	65		review of new evidence, research, and treatments; or
70	66		(2) if clinical practice guidelines described by
71	67		Subdivision (1) are not reasonably available, may be based on
72	68		peer-reviewed publications developed by independent experts, which
73	69		may include physicians, with expertise applicable to the relevant
74	70		health condition.
75	71		(b) A multidisciplinary panel of experts composed of
76	72		physicians and, as necessary, other health care providers that
77	73		develops and endorses clinical practice guidelines under
78	74		Subsection (a)(1) must manage conflicts of interest by:
79	75		(1) requiring each member of the panel's writing or
80	76		review group to:
81	77		(A) disclose any potential conflict of interest,
82	78		including a conflict of interest involving an insurer, health
83	79		benefit plan issuer, or pharmaceutical manufacturer; and
84	80		(B) recuse himself or herself in any situation in
85	81		which the member has a conflict of interest;
86	82		(2) using a methodologist to work with writing groups
87	83		to provide objectivity in data analysis and the ranking of evidence
88	84		by preparing evidence tables and facilitating consensus; and
89	85		(3) offering an opportunity for public review and
90	86		comment.
91	87		(c) Subsection (b) does not apply to a panel or committee of
92	88		experts, including a pharmacy and therapeutics committee,
93	89		established by a health benefit plan issuer or a pharmacy benefit
94	90		manager that advises the health benefit plan issuer or pharmacy
95	91		benefit manager regarding drugs or formularies.
96	92		Sec. 1369.0546. STEP THERAPY PROTOCOL EXCEPTION REQUESTS.
97	93		(a) A health benefit plan issuer shall establish a process in a
98	94		user-friendly format that is readily accessible to a patient and
99	95		prescribing provider, in the health benefit plan's formulary
100	96		document and otherwise, through which an exception request under
101	97		this section may be submitted by the provider.
102	98		(b) A prescribing provider on behalf of a patient may submit
103	99		to the patient's health benefit plan issuer a written request for an
104	100		exception to a step therapy protocol required by the patient's
105	101		health benefit plan. The provider shall submit the request on the
106	102		standard form prescribed by the commissioner under Section
107	103		1369.304.
108	104		(c) A health benefit plan issuer shall grant a written
109	105		request under Subsection (b) if the request includes the
110	106		prescribing provider's written statement, with supporting
111	107		documentation, stating that:
112	108		(1) the drug required under the step therapy protocol:
113	109		(A) is contraindicated;
114	110		(B) will likely cause an adverse reaction in or
115	111		physical or mental harm to the patient; or
116	112		(C) is expected to be ineffective based on the
117	113		known clinical characteristics of the patient and the known
118	114		characteristics of the prescription drug regimen;
119	115		(2) the patient previously discontinued taking the
120	116		drug required under the step therapy protocol, or another
121	117		prescription drug in the same pharmacologic class or with the same
122	118		mechanism of action as the required drug, while under the health
123	119		benefit plan currently in force or while covered under another
124	120		health benefit plan because the drug was not effective or had a
125	121		diminished effect or because of an adverse event;
126	122		(3) the drug required under the step therapy protocol
127	123		is not in the best interest of the patient, based on clinical
128	124		appropriateness, because the patient's use of the drug is expected
129	125		to:
130	126		(A) cause a significant barrier to the patient's
131	127		adherence to or compliance with the patient's plan of care;
132	128		(B) worsen a comorbid condition of the patient;
133	129		or
134	130		(C) decrease the patient's ability to achieve or
135	131		maintain reasonable functional ability in performing daily
136	132		activities; or
137	133		(4)(A) the drug that is subject to the step therapy
138	134		protocol was prescribed for the patient's condition;
139	135		(B) the patient:
140	136		(i) received benefits for the drug under
141	137		the health benefit plan currently in force or a previous health
142	138		benefit plan; and
143	139		(ii) is stable on the drug; and
144	140		(C) the change in the patient's prescription drug
145	141		regimen required by the step therapy protocol is expected to be
146	142		ineffective or cause harm to the patient based on the known clinical
147	143		characteristics of the patient and the known characteristics of the
148	144		required prescription drug regimen.
149	145		(d) Except as provided by Subsection (e), if a health
150	146		benefit plan issuer does not deny an exception request described by
151	147		Subsection (c) before 72 hours after the health benefit plan issuer
152	148		receives the request, the request is considered granted.
153	149		(e) If an exception request described by Subsection (c) also
154	150		states that the prescribing provider reasonably believes that
155	151		denial of the request makes the death of or serious harm to the
156	152		patient probable, the request is considered granted if the health
157	153		benefit plan issuer does not deny the request before 24 hours after
158	154		the health benefit plan issuer receives the request.
159	155		(f) The denial of an exception request under this section is
160	156		an adverse determination for purposes of Section 4201.002 and is
161	157		subject to appeal under Subchapters H and I, Chapter 4201.
162	158		SECTION 3. Section 4201.357, Insurance Code, is amended by
163	159		adding Subsection (a-2) to read as follows:
164	160		(a-2) An adverse determination under Section 1369.0546 is
165	161		entitled to an expedited appeal. The physician or, if appropriate,
166	162		other health care provider deciding the appeal must consider
167	163		atypical diagnoses and the needs of atypical patient populations.
168	164		SECTION 4. Section 4202.003, Insurance Code, is amended to
169	165		read as follows:
170	166		Sec. 4202.003. REQUIREMENTS REGARDING TIMELINESS OF
171	167		DETERMINATION. The standards adopted under Section 4202.002 must
172	168		require each independent review organization to make the
173	169		organization's determination:
174	170		(1) for a life-threatening condition as defined by
175	171		Section 4201.002, [or] the provision of prescription drugs or
176	172		intravenous infusions for which the patient is receiving benefits
177	173		under the health insurance policy, or a review of a step therapy
178	174		protocol exception request under Section 1369.0546, not later than
179	175		the earlier of the third day after the date the organization
180	176		receives the information necessary to make the determination or,
181	177		with respect to:
182	178		(A) a review of a health care service provided to
183	179		a person with a life-threatening condition eligible for workers'
184	180		compensation medical benefits, the eighth day after the date the
185	181		organization receives the request that the determination be made;
186	182		or
187	183		(B) a review of a health care service other than a
188	184		service described by Paragraph (A), the third day after the date the
189	185		organization receives the request that the determination be made;
190	186		or
191	187		(2) for a situation other than a situation described
192	188		by Subdivision (1), not later than the earlier of:
193	189		(A) the 15th day after the date the organization
194	190		receives the information necessary to make the determination; or
195	191		(B) the 20th day after the date the organization
196	192		receives the request that the determination be made.
197	193		SECTION 5. The changes in law made by this Act apply only to
198	194		a health benefit plan that is delivered, issued for delivery, or
199	195		renewed on or after January 1, 2018. A health benefit plan
200	196		delivered, issued for delivery, or renewed before January 1, 2018,
201	197		is governed by the law as it existed immediately before the
202	198		effective date of this Act, and that law is continued in effect for
203	199		that purpose.
204	200		SECTION 6. This Act takes effect September 1, 2017.
	201	+	______________________________ ______________________________
	202	+	President of the Senate Speaker of the House
	203	+	I hereby certify that S.B. No. 680 passed the Senate on
	204	+	April 3, 2017, by the following vote: Yeas 31, Nays 0; and that
	205	+	the Senate concurred in House amendment on May 16, 2017, by the
	206	+	following vote: Yeas 30, Nays 0.
	207	+	______________________________
	208	+	Secretary of the Senate
	209	+	I hereby certify that S.B. No. 680 passed the House, with
	210	+	amendment, on May 9, 2017, by the following vote: Yeas 144,
	211	+	Nays 2, one present not voting.
	212	+	______________________________
	213	+	Chief Clerk of the House
	214	+	Approved:
	215	+	______________________________
	216	+	Date
	217	+	______________________________
	218	+	Governor