Texas 2017 - 85th Regular

Texas House Bill HB3732 Compare Versions

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1	1	By: Raymond H.B. No. 3732
2	2
3	3
4	4	A BILL TO BE ENTITLED
5	5	AN ACT
6	6	relating to prescription drug benefits under the Medicaid program.
7	7	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
8	8	SECTION 1. Section 531.073(a), Government Code, is amended
9	9	to read as follows:
10	10	(a) The executive commissioner, in the rules and standards
11	11	governing the Medicaid vendor drug program and the child health
12	12	plan program, shall require prior authorization for the
13	13	reimbursement of a drug that is not included in the appropriate
14	14	preferred drug list adopted under Section 531.072, except as
15	15	provided by Section 531.0731 and for any drug exempted from prior
16	16	authorization requirements by federal law. Except as provided by
17	17	Section 531.0731, the [The] executive commissioner may require
18	18	prior authorization for the reimbursement of a drug provided
19	19	through any other state program administered by the commission or a
20	20	state health and human services agency, including a community
21	21	mental health center and a state mental health hospital if the
22	22	commission adopts preferred drug lists under Section 531.072 that
23	23	apply to those facilities and the drug is not included in the
24	24	appropriate list. The executive commissioner shall require that the
25	25	prior authorization be obtained by the prescribing physician or
26	26	prescribing practitioner.
27	27	SECTION 2. Subchapter B, Chapter 531, Government Code, is
28	28	amended by adding Section 531.0731 to read as follows:
29	29	Sec. 531.0731. CONTINUITY OF CARE IN RELATION TO
30	30	PRESCRIPTION DRUGS. The commission shall ensure that a
31	31	prescription drug prescribed to a person who is newly enrolled in
32	32	the child health plan program, Medicaid, or another state program
33	33	administered by the commission or a health and human services
34	34	agency, or who is newly enrolled in a Medicaid managed care health
35	35	plan, is not subject to a prior authorization requirement for up to
36	36	one year after the date of the person's enrollment, if:
37	37	(1) the patient had previously been prescribed the
38	38	drug to treat a medical condition; and
39	39	(2) the person's physician prescribes the drug to
40	40	treat the person's medical condition based on the physician's
41	41	determination that the prescription is the most appropriate course
42	42	of treatment for the medical condition.
43	43	SECTION 3. Section 531.0736, Government Code, is amended by
44	44	amending Subsection (b) to read as follows:
45	45	(b) In addition to performing any other duties required by
46	46	federal law, the board shall:
47	47	(1) develop and submit to the commission
48	48	recommendations for preferred drug lists adopted by the commission
49	49	under Section 531.072;
50	50	(2) suggest to the commission restrictions or clinical
51	51	edits on prescription drugs in accordance with Section 531.0738;
52	52	(3) review existing restrictions or clinical edits on
53	53	prescription drugs for appropriateness in accordance with Section
54	54	531.0738;
55	55	(4) recommend to the commission educational
56	56	interventions for Medicaid providers;
57	57	(5) [(4)] review drug utilization across Medicaid;
58	58	and
59	59	(6) [(5)] perform other duties that may be specified
60	60	by law and otherwise make recommendations to the commission.
61	61	SECTION 4. Subchapter B, Chapter 531, is amended by adding
62	62	Sections 531.0738, 531.07381, 531.07382, and 531.07383 to read as
63	63	follows:
64	64	Sec. 531.0738. DRUG UTILIZATION REVIEW BOARD: SUGGESTION
65	65	AND REVIEW OF RESTRICTIONS AND CLINICAL EDITS. (a) In performing
66	66	the requirements under Sections 531.0736(b)(2) and (3), the board
67	67	shall evaluate the appropriateness of and make a recommendation
68	68	regarding a restriction or clinical edit or protocol on a
69	69	prescription drug. The committee's evaluation and recommendation
70	70	must:
71	71	(1) be based on only a determination of the safety and
72	72	efficacy of the restriction or clinical edit or protocol;
73	73	(2) ensure the restriction or clinical edit is written
74	74	for the needs of all applicable populations, including pediatric
75	75	and obstetric populations; and
76	76	(3) include an explanation of the basis for the
77	77	committee's recommendation that is written in such a way that would
78	78	allow a person without medical training to understand.
79	79	(b) To perform the requirements under Section
80	80	531.0736(b)(3), the board shall establish a periodic review
81	81	schedule for existing restrictions or clinical edits or protocols.
82	82	The schedule must require review of a restriction or clinical edit
83	83	on a prescription drug no less frequently than once every two years.
84	84	A restriction or clinical edit on a prescription drug has no effect
85	85	and may not be enforced beginning on the date of the second
86	86	anniversary of the most recent review of the restriction or edit by
87	87	the board unless the restriction or clinical edit has been
88	88	evaluated and renewed by the board.
89	89	(c) In determining the safety and efficacy of a restriction
90	90	or clinical edit, the board:
91	91	(1) may consider public comment or clinical
92	92	information including scientific evidence, standards of practice,
93	93	peer-reviewed medical literature, randomized clinical trials,
94	94	pharmacoeconomic studies, and outcomes research data; and
95	95	(2) may not rely solely on manufacturer package
96	96	inserts.
97	97	Sec. 531.07381. SUSPENSION OF RESTRICTION OR CLINICAL EDIT
98	98	ON PRESCRIPTION DRUG. The executive commissioner by rule shall
99	99	adopt a process by which the commission amends or suspends a
100	100	restriction or clinical edit on a prescription drug. The process
101	101	must:
102	102	(1) allow providers or Medicaid managed care
103	103	organization medical or pharmacy directors to submit to the
104	104	commission evidence that the restriction or clinical edit:
105	105	(A) jeopardizes patient safety or care by
106	106	imposing undue administrative burdens to patients or providers; or
107	107	(B) is clinically inaccurate or otherwise
108	108	inappropriate;
109	109	(2) require the commission's Medicaid medical director
110	110	to:
111	111	(A) review submitted clinical information to
112	112	determine whether the restriction or clinical edit should be
113	113	amended or suspended in the interest of patient safety or care; and
114	114	(B) submit a recommendation based on the medical
115	115	director's determination regarding the restriction or clinical
116	116	edit to the executive commissioner; and
117	117	(3) no later than 10 business days after the date the
118	118	executive commissioner receives the medical director's
119	119	recommendation), require the executive commissioner to amend or
120	120	suspend the restriction or clinical edit in accordance with the
121	121	medical director's determination, as applicable.
122	122	Sec. 531.07382. STEP THERAPY PROTOCOLS. (a) In this
123	123	section and in Section 531.07383:
124	124	(1) "Clinical practice guideline" means a statement
125	125	systematically developed by physicians and other health care
126	126	providers to assist a patient or health care provider in making a
127	127	decision about appropriate health care for a specific clinical
128	128	circumstance or condition.
129	129	(2) "Clinical review criteria" means the written
130	130	screening procedures, decision abstracts, clinical protocols, and
131	131	practice guidelines used by a health benefit plan issuer,
132	132	utilization review organization, or independent review
133	133	organization to determine the medical necessity and
134	134	appropriateness of a health care service or prescription drug.
135	135	(3) "Step therapy protocol" means a protocol that
136	136	requires an enrollee to use a prescription drug or sequence of
137	137	prescription drugs other than the drug that the enrollee's
138	138	physician recommends for the enrollee's treatment before the health
139	139	benefit plan provides coverage for the recommended drug.
140	140	(b) The commission may require a step therapy protocol
141	141	before providing coverage for a prescription drug only if the
142	142	commission establishes, implements, and administers the step
143	143	therapy protocol in accordance with clinical review criteria
144	144	readily available to the health care industry. The clinical review
145	145	criteria must be based on:
146	146	(1) generally accepted clinical practice guidelines
147	147	that are:
148	148	(A) developed and endorsed by a
149	149	multidisciplinary panel of experts described by Subsection (b); and
150	150	(B) based on high quality studies, research, and
151	151	medical practice that are:
152	152	(i) created by an explicit and transparent
153	153	process that:
154	154	(a) minimizes bias and conflicts of
155	155	interest;
156	156	(b) explains the relationship between
157	157	treatment options and outcomes;
158	158	(c) rates the quality of the evidence
159	159	supporting the recommendations; and
160	160	(d) considers relevant patient
161	161	subgroups and preferences; and
162	162	(ii) updated at appropriate intervals after
163	163	a review of new evidence, research, and treatments; or
164	164	(2) if clinical practice guidelines described by
165	165	Subdivision (1) are not reasonably available, peer-reviewed
166	166	publications developed by independent experts, which must include
167	167	physicians, with expertise applicable to the relevant health
168	168	condition.
169	169	(c) A multidisciplinary panel of experts consisting of
170	170	physicians and other health care providers that develops and
171	171	endorses clinical practice guidelines under Subsection (a)(1) must
172	172	manage conflicts of interest by:
173	173	(1) requiring each member of the panel's writing or
174	174	review group to:
175	175	(A) disclose any potential conflict of interest,
176	176	including a conflict of interest involving an insurer, managed care
177	177	organization, or pharmaceutical manufacturer; and
178	178	(B) recuse himself or herself in any situation in
179	179	which the member has a conflict of interest;
180	180	(2) using a methodologist to work with writing groups
181	181	to provide objectivity in data analysis and the ranking of evidence
182	182	by preparing evidence tables and facilitating consensus; and
183	183	(3) offering an opportunity for public review and
184	184	comment.
185	185	(d) This section may not be construed to prohibit:
186	186	(1) the commission from requiring a patient to try an
187	187	AB-rated generic equivalent drug before providing coverage for the
188	188	equivalent branded prescription drug, unless the drug:
189	189	(A) has been demonstrated to be ineffective on
190	190	the patient;
191	191	(B) has caused an adverse reaction in or physical
192	192	or mental harm to the patient; or
193	193	(C) is likely to cause an adverse reaction in or
194	194	physical or mental harm to the patient; or
195	195	(2) a prescribing provider from prescribing a
196	196	prescription drug that is determined to be medically appropriate.
197	197	Sec. 531.07383. OVERRIDE OF RESTRICTIONS ON MEDICATION
198	198	SEQUENCE IN STEP THERAPY PROTOCOL. (a) The commission shall
199	199	establish a clear and convenient process for a prescribing health
200	200	professional to request electronically, in writing, or by phone an
201	201	override of a step therapy protocol.
202	202	(b) The commission shall grant a request for an override of
203	203	a step therapy protocol to a prescribing health professional
204	204	within, subject to Subsections (c) and (d), a reasonable time after
205	205	the health professional completes the process for the request of
206	206	the override, if:
207	207	(1) the prescribing health professional can
208	208	demonstrate that the patient has previously failed the preferred
209	209	treatment required under the step therapy protocol, or that the
210	210	preferred treatment or another drug in the same pharmacologic class
211	211	or with the same mechanism of action as the preferred treatment, has
212	212	been ineffective or had a diminished effect for the treatment of a
213	213	recipient's medical condition after two attempts of following the
214	214	protocol; or
215	215	(2) based on sound clinical evidence or medical and
216	216	scientific evidence, the prescribing health professional can
217	217	demonstrate that the preferred treatment required under the step
218	218	therapy protocol:
219	219	(A) is expected or likely to be ineffective based
220	220	on the known relevant physical or mental characteristics of the
221	221	recipient and known characteristics of the drug regimen; or
222	222	(B) will cause or will likely cause an adverse
223	223	reaction in or physical or mental harm to the recipient.
224	224	(c) Except as provided by Subsection (e), if the commission
225	225	does not deny an exception request described by Subsection (a)
226	226	before 48 hours after the commission receives the request, the
227	227	request is considered granted.
228	228	(d) If an exception request described by Subsection (c) also
229	229	states that the prescribing provider reasonably believes that
230	230	denial of the request makes the death of or serious harm to the
231	231	patient probable, the request is considered granted if commission
232	232	does not deny the request before 24 hours after the organization
233	233	receives the request.
234	234	(e) The process established under this section must allow a
235	235	prescribing health professional to appeal a denial of a request for
236	236	an override of a step therapy protocol to the commission's medical
237	237	director.
238	238	SECTION 5. Section 531.0741, Government Code, is amended to
239	239	read as follows:
240	240	Sec. 531.0741. PUBLICATION OF INFORMATION REGARDING
241	241	COMMISSION AND DRUG UTILIZATION REVIEW BOARD DECISIONS [ON
242	242	PREFERRED DRUG LIST PLACEMENT]. (a) The commission shall publish
243	243	on the commission's Internet website any decisions on preferred
244	244	drug list placement, including:
245	245	(1) a list of drugs reviewed and the commission's
246	246	decision for or against placement on a preferred drug list of each
247	247	drug reviewed;
248	248	(2) for each recommendation, whether a supplemental
249	249	rebate agreement or a program benefit agreement was reached under
250	250	Section 531.070; and
251	251	(3) the rationale for any departure from a
252	252	recommendation of the Drug Utilization Review Board under Section
253	253	531.0736.
254	254	(b) The commission shall publish on the commission's
255	255	Internet website in a section of the website dedicated to
256	256	prescription drug information:
257	257	(1) information on restrictions or clinical edits for
258	258	a prescription drug, including a preferred drug, including the
259	259	evaluation and recommendation required under Section 531.0738 that
260	260	relates to the restriction or clinical edit; and
261	261	(2) the periodic review schedule established under
262	262	Section 531.0738(b).
263	263	(c) The commission must publish the information required
264	264	under this section in a manner that would allow a provider to search
265	265	a preferred drug list to easily determine whether a prescription
266	266	drug or drug class is subject to any restrictions or clinical edits.
267	267	SECTION 6. Subchapter B, Chapter 531, Government Code is
268	268	amended by adding Section 531.0761 to read as follows:
269	269	Sec. 531.0761. PRESCRIPTION OF GENERIC EQUIVALENTS. (a)
270	270	Notwithstanding any other section of law and in a manner that
271	271	complies with applicable federal law, the commission shall ensure
272	272	that a preferred drug list adopted by the commission for the
273	273	Medicaid vendor drug program and for prescription drugs purchased
274	274	through the child health plan program establishes a generic
275	275	equivalent of a prescribed drug as a preferred drug.
276	276	(b) If a physician or other health care practitioner acting
277	277	within the practitioner's scope of delegated authority writes a
278	278	prescription for a generic equivalent of a prescribed drug, the
279	279	commission may not require the physician or practitioner to specify
280	280	the national drug code on the prescription.
281	281	Sec. 531.0762. UPDATING NATIONAL DRUG CODES. (a) No later
282	282	than the 15th business day after the day the commission receives
283	283	notice from the Centers for Medicaid and Medicare Services that a
284	284	National Drug Code has been eliminated or changed, the commission
285	285	shall update its electronic database and notify Medicaid managed
286	286	care organizations.
287	287	SECTION 7. Subchapter A, Chapter 533, Government Code, is
288	288	amended by adding Section 533.022 to read as follows:
289	289	Sec. 533.022. PHARMACY BENEFIT PLAN REQUIREMENTS. (a) The
290	290	commission shall require that the pharmacy benefit plan of a
291	291	managed care organization that contracts with the commission to
292	292	provide health care services to recipients must:
293	293	(1) adopt the restrictions or clinical edits as
294	294	recommended by the Drug Utilization Review Board under Section
295	295	531.0738 and impose no other restrictions or clinical edits than
296	296	those recommended by the board;
297	297	(2) adopt the process adopted under Section 531.07381
298	298	for amending or suspending a restriction or clinical edit on a
299	299	prescription drug;
300	300	(3) adhere to the step therapy guidelines and override
301	301	procedures under Sections 531.07382 and 531.07383, including a
302	302	procedure for an appeal under Section 531.07383(e) to the managed
303	303	care organization's medical director.
304	304	SECTION 8. Section 533.005(a-1), Government Code, is
305	305	amended to read as follows:
306	306	(a-1) The requirements imposed by Subsections (a)(23)(A),
307	307	(B), and (C) do not apply, and may not be enforced, on and after
308	308	August 31, 2030 [2018].
309	309	SECTION 9. If before implementing any provision of this Act
310	310	a state agency determines that a waiver or authorization from a
311	311	federal agency is necessary for implementation of that provision,
312	312	the agency affected by the provision shall request the waiver or
313	313	authorization and may delay implementing that provision until the
314	314	waiver or authorization is granted.
315	315	SECTION 10. (a) The Drug Utilization Review Board shall
316	316	establish a schedule for reviewing restrictions and clinical edits
317	317	on prescription drugs provided as benefits under the Medicaid
318	318	program as required by Section 531.0738, Government Code, as added
319	319	by this Act, no later than March 1, 2018.
320	320	(b) The Drug Utilization Review Board shall complete a
321	321	review of all restrictions and clinical edits on prescription drugs
322	322	that are provided as benefits under the Medicaid program that are in
323	323	effect on the effective date of this Act, as required by Section
324	324	531.0738, Government Code, as added by this Act, no later than
325	325	September 1, 2018.
326	326	(c) The Health and Human Services Commission may not allow a
327	327	restriction or clinical edit on a prescription drug provided as a
328	328	benefit under the Medicaid program to be enforced or to have any
329	329	effect before the Drug Utilization Review Board reviews the
330	330	restriction or clinical edit in accordance with Subsection (b) of
331	331	this SECTION, unless the Health and Human Services Commission
332	332	requires the enforcement or imposition of the restriction or
333	333	clinical edit by administrative rule or by contract with a managed
334	334	care organization that contracts with the commission to provide
335	335	health care benefits to enrollees in the Medicaid program.
336	336	SECTION 11. This Act takes effect immediately if it
337	337	receives a vote of two-thirds of all the members elected to each
338	338	house, as provided by Section 39, Article III, Texas Constitution.
339	339	If this Act does not receive the vote necessary for immediate
340	340	effect, this Act takes effect September 1, 2017.