Texas 2019 - 86th Regular

Texas House Bill HB3284 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1		-	H.B. No. 3284
	1	+	By: Sheffield, et al. (Senate Sponsor - Nelson) H.B. No. 3284
	2	+	(In the Senate - Received from the House May 13, 2019;
	3	+	May 14, 2019, read first time and referred to Committee on Health &
	4	+	Human Services; May 20, 2019, reported adversely, with favorable
	5	+	Committee Substitute by the following vote: Yeas 9, Nays 0;
	6	+	May 20, 2019, sent to printer.)
	7	+	Click here to see the committee vote
	8	+	COMMITTEE SUBSTITUTE FOR H.B. No. 3284 By: Perry
2	9
3	10
	11	+	A BILL TO BE ENTITLED
4	12		AN ACT
5		-	relating to the prescribing and dispensing of controlled substances
	13	+	relating to prescribing and dispensing controlled substances and
	14	+	monitoring the prescribing and dispensing of controlled substances
6	15		under the Texas Controlled Substances Act; authorizing a fee;
7	16		providing for administrative penalties; creating criminal
8	17		offenses.
9	18		BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
10		-	SECTION 1. Section 481.076, Health and Safety Code, is
	19	+	SECTION 1. Subchapter C, Chapter 481, Health and Safety
	20	+	Code, is amended by adding Section 481.0755 to read as follows:
	21	+	Sec. 481.0755. WRITTEN, ORAL, AND TELEPHONICALLY
	22	+	COMMUNICATED PRESCRIPTIONS. (a) Notwithstanding Sections
	23	+	481.073, 481.074, and 481.075, a person prescribing or dispensing a
	24	+	controlled substance must use the electronic prescription record
	25	+	and may not use a written, oral, or telephonically communicated
	26	+	prescription.
	27	+	(b) A prescriber may issue a written, oral, or
	28	+	telephonically communicated prescription for a controlled
	29	+	substance as authorized under this subchapter only if the
	30	+	prescription is issued:
	31	+	(1) by a veterinarian;
	32	+	(2) in circumstances in which electronic prescribing
	33	+	is not available due to temporary technological or electronic
	34	+	failure, as prescribed by board rule;
	35	+	(3) by a practitioner to be dispensed by a pharmacy
	36	+	located outside this state, as prescribed by board rule;
	37	+	(4) when the prescriber and dispenser are the same
	38	+	entity;
	39	+	(5) in circumstances in which necessary elements are
	40	+	not supported by the most recent electronic prescription drug
	41	+	software;
	42	+	(6) for a drug for which the United States Food and
	43	+	Drug Administration requires additional information in the
	44	+	prescription that is not possible with electronic prescribing;
	45	+	(7) for a non-patient-specific prescription pursuant
	46	+	to a standing order, approved protocol for drug therapy,
	47	+	collaborative drug management, or comprehensive medication
	48	+	management, in response to a public health emergency or in other
	49	+	circumstances in which the practitioner may issue a
	50	+	non-patient-specific prescription;
	51	+	(8) for a drug under a research protocol;
	52	+	(9) by a prescriber who is employed by or is practicing
	53	+	a health care profession at a health-related institution, as
	54	+	defined by Section 62.161, Education Code, as added by Chapter 448
	55	+	(H.B. 7), Acts of the 84th Legislature, 2015;
	56	+	(10) by a practitioner who has received a waiver under
	57	+	Subsection (c) from the requirement to use electronic prescribing;
	58	+	or
	59	+	(11) under circumstances in which the practitioner has
	60	+	the present ability to submit an electronic prescription but
	61	+	reasonably determines that it would be impractical for the patient
	62	+	to obtain the drugs prescribed under the electronic prescription in
	63	+	a timely manner and that a delay would adversely impact the
	64	+	patient's medical condition.
	65	+	(c) The board shall adopt rules establishing a process by
	66	+	which a practitioner may request and receive a waiver under
	67	+	Subsection (b)(10), not to exceed one year, from the requirement to
	68	+	use electronic prescribing. The board shall adopt rules
	69	+	establishing the eligibility for a waiver, including:
	70	+	(1) economic hardship;
	71	+	(2) technological limitations not reasonably within
	72	+	the control of the practitioner; or
	73	+	(3) other exceptional circumstances demonstrated by
	74	+	the practitioner.
	75	+	(d) A written, oral, or telephonically communicated
	76	+	prescription must comply with the applicable requirements
	77	+	prescribed by Sections 481.074 and 481.075.
	78	+	(e) A dispensing pharmacist who receives a controlled
	79	+	substance prescription in a manner other than electronically is not
	80	+	required to verify that the prescription is exempt from the
	81	+	requirement that it be submitted electronically.
	82	+	(f) The board shall enforce this section.
	83	+	SECTION 2. Section 481.076, Health and Safety Code, is
11	84		amended by amending Subsections (a), (f), (g), and (h) and adding
12	85		Subsection (a-6) to read as follows:
13	86		(a) The board may not permit any person to have access to
14	87		information submitted to the board under Section 481.074(q) or
15	88		481.075 except:
16	89		(1) the board, the Texas Medical Board, the Texas
17	90		Department of Licensing and Regulation, with respect to the
18	91		regulation of podiatrists [State Board of Podiatric Medical
19	92		Examiners], the State Board of Dental Examiners, the State Board of
20	93		Veterinary Medical Examiners, the Texas Board of Nursing, or the
21	94		Texas Optometry Board for the purpose of:
22	95		(A) investigating a specific license holder; or
23	96		(B) monitoring for potentially harmful
24	97		prescribing or dispensing patterns or practices under Section
25	98		481.0762;
26	99		(2) an [authorized officer or member of the department
27	100		or] authorized employee of the board engaged in the administration,
28	101		investigation, or enforcement of this chapter or another law
29	102		governing illicit drugs in this state or another state;
30	103		(3) the department or other [on behalf of a] law
31	104		enforcement or prosecutorial official engaged in the
32	105		administration, investigation, or enforcement of this chapter or
33	106		another law governing illicit drugs in this state or another state,
34	107		if the board is provided a warrant, subpoena, or other court order
35	108		compelling the disclosure;
36	109		(4) a medical examiner conducting an investigation;
37	110		(5) provided that accessing the information is
38	111		authorized under the Health Insurance Portability and
39	112		Accountability Act of 1996 (Pub. L. No. 104-191) and regulations
40	113		adopted under that Act:
41	114		(A) a pharmacist or a pharmacy technician, as
42	115		defined by Section 551.003, Occupations Code, acting at the
43	116		direction of a pharmacist; or
44	117		(B) a practitioner who:
45	118		(i) is a physician, dentist, veterinarian,
46	119		podiatrist, optometrist, or advanced practice nurse or is a
47	120		physician assistant described by Section 481.002(39)(D) or an
48	121		employee or other agent of a practitioner acting at the direction of
49	122		a practitioner; and
50	123		(ii) is inquiring about a recent Schedule
51	124		II, III, IV, or V prescription history of a particular patient of
52	125		the practitioner;
53	126		(6) a pharmacist or practitioner who is inquiring
54	127		about the person's own dispensing or prescribing activity; [or]
55	128		(7) one or more states or an association of states with
56	129		which the board has an interoperability agreement, as provided by
57	130		Subsection (j);
58	131		(8) a health care facility certified by the federal
59	132		Centers for Medicare and Medicaid Services; or
60	133		(9) the patient, the patient's parent or legal
61	134		guardian, if the patient is a minor, or the patient's legal
62	135		guardian, if the patient is an incapacitated person, as defined by
63	136		Section 1002.017(2), Estates Code, inquiring about the patient's
64	137		prescription record, including persons who have accessed that
65	138		record.
66	139		(a-6) A patient, the patient's parent or legal guardian, if
67	140		the patient is a minor, or the patient's legal guardian, if the
68	141		patient is an incapacitated person, as defined by Section
69	142		1002.017(2), Estates Code, is entitled to a copy of the patient's
70	143		prescription record as provided by Subsection (a)(9), including a
71	144		list of persons who have accessed that record, if a completed
72	145		patient data request form and any supporting documentation required
73	146		by the board is submitted to the board. The board may charge a
74	147		reasonable fee for providing the copy. The board shall adopt rules
75	148		to implement this subsection, including rules prescribing the
76	149		patient data request form, listing the documentation required for
77	150		receiving a copy of the prescription record, and setting the fee.
78	151		(f) If the board accesses [director permits access to]
79	152		information under Subsection (a)(2) relating to a person licensed
80	153		or regulated by an agency listed in Subsection (a)(1), the board
81	154		[director] shall notify and cooperate with that agency regarding
82	155		the disposition of the matter before taking action against the
83	156		person, unless the board [director] determines that notification is
84	157		reasonably likely to interfere with an administrative or criminal
85	158		investigation or prosecution.
86	159		(g) If the board provides [director permits] access to
87	160		information under Subsection (a)(3) relating to a person licensed
88	161		or regulated by an agency listed in Subsection (a)(1), the board
89	162		[director] shall notify that agency of the disclosure of the
90	163		information not later than the 10th working day after the date the
91	164		information is disclosed.
92	165		(h) If the board [director] withholds notification to an
93	166		agency under Subsection (f), the board [director] shall notify the
94	167		agency of the disclosure of the information and the reason for
95	168		withholding notification when the board [director] determines that
96	169		notification is no longer likely to interfere with an
97	170		administrative or criminal investigation or prosecution.
98		-	SECTION 2. Section 481.0766, Health and Safety Code, is
	171	+	SECTION 3. Section 481.0766, Health and Safety Code, is
99	172		amended by adding Subsection (c) to read as follows:
100	173		(c) The board shall make the information reported under
101	174		Subsection (a) available to the State Board of Veterinary Medical
102	175		Examiners for the purpose of routine inspections and
103	176		investigations.
104		-	SECTION 3. Subchapter C, Chapter 481, Health and Safety
	177	+	SECTION 4. Subchapter C, Chapter 481, Health and Safety
105	178		Code, is amended by adding Sections 481.0767, 481.0768, and
106	179		481.0769 to read as follows:
107	180		Sec. 481.0767. ADVISORY COMMITTEE. (a) The board shall
108	181		establish an advisory committee to make recommendations regarding
109	182		information submitted to the board and access to that information
110	183		under Sections 481.074, 481.075, 481.076, and 481.0761, including
111	184		recommendations for:
112	185		(1) operational improvements to the electronic system
113	186		that stores the information, including implementing best practices
114	187		and improvements that address system weaknesses and workflow
115	188		challenges;
116	189		(2) resolutions to identified data concerns;
117	190		(3) methods to improve data accuracy, integrity, and
118	191		security and to reduce technical difficulties; and
119	192		(4) the addition of any new data set or service to the
120	193		information submitted to the board or the access to that
121	194		information.
122	195		(b) The board shall appoint the following members to the
123	196		advisory committee:
124	197		(1) a physician licensed in this state who practices
125	198		in pain management;
126	199		(2) a physician licensed in this state who practices
127	200		in family medicine;
128	201		(3) a physician licensed in this state who performs
129	202		surgery;
130	203		(4) a physician licensed in this state who practices
131	204		in emergency medicine at a hospital;
132	205		(5) a physician licensed in this state who practices
133	206		in psychiatry;
134	207		(6) an oral and maxillofacial surgeon;
135	208		(7) a physician assistant or advanced practice
136	209		registered nurse to whom a physician has delegated the authority to
137	210		prescribe or order a drug;
138	211		(8) a pharmacist working at a chain pharmacy;
139	212		(9) a pharmacist working at an independent pharmacy;
140	213		(10) an academic pharmacist; and
141	214		(11) two representatives of the health information
142	215		technology industry, at least one of whom is a representative of a
143	216		company whose primary line of business is electronic medical
144	217		records.
145	218		(c) Members of the advisory committee serve three-year
146	219		terms. Each member shall serve until the member's replacement has
147	220		been appointed.
148	221		(d) The advisory committee shall annually elect a presiding
149	222		officer from its members.
150	223		(e) The advisory committee shall meet at least two times a
151	224		year and at the call of the presiding officer or the board.
152	225		(f) A member of the advisory committee serves without
153	226		compensation but may be reimbursed by the board for actual expenses
154	227		incurred in performing the duties of the advisory committee.
155	228		Sec. 481.0768. ADMINISTRATIVE PENALTY: DISCLOSURE OR USE
156	229		OF INFORMATION. (a) A person authorized to receive information
157	230		under Section 481.076(a) may not disclose or use the information in
158	231		a manner not authorized by this subchapter or other law.
159	232		(b) A regulatory agency that issues a license,
160	233		certification, or registration to a prescriber or dispenser shall
161	234		periodically update the administrative penalties, or any
162	235		applicable disciplinary guidelines concerning the penalties,
163	236		assessed by that agency for conduct that violates Subsection (a).
164	237		(c) The agency shall set the penalties in an amount
165	238		sufficient to deter the conduct.
166	239		Sec. 481.0769. CRIMINAL OFFENSES RELATED TO PRESCRIPTION
167	240		INFORMATION. (a) A person authorized to receive information under
168	241		Section 481.076(a) commits an offense if the person discloses or
169	242		uses the information in a manner not authorized by this subchapter
170	243		or other law.
171	244		(b) A person requesting information under Section
172	245		481.076(a-6) commits an offense if the person makes a material
173	246		misrepresentation or fails to disclose a material fact in the
174	247		request for information under that subsection.
175	248		(c) An offense under Subsection (a) is a Class A
176	249		misdemeanor.
177	250		(d) An offense under Subsection (b) is a Class C
178	251		misdemeanor.
179		-	SECTION 4. Section 801.307, Occupations Code, is amended by
	252	+	SECTION 5. Section 801.307, Occupations Code, is amended by
180	253		adding Subsection (a-1) to read as follows:
181	254		(a-1) The board by rule shall require a veterinarian to
182	255		complete two hours of continuing education related to opioid abuse
183	256		and controlled substance diversion, inventory, and security every
184	257		two years to renew a license to practice veterinary medicine.
185		-	SECTION 5. Section 481.003(a), Health and Safety Code, is
	258	+	SECTION 6. Section 481.003(a), Health and Safety Code, is
186	259		amended to read as follows:
187	260		(a) The director may adopt rules to administer and enforce
188	261		this chapter, other than Sections 481.073, 481.074, 481.075,
189		-	481.076, 481.0761, 481.0762, 481.0763, 481.0764, 481.0765, [and]
190		-	481.0766, 481.0767, 481.0768, and 481.0769. The board may adopt
191		-	rules to administer Sections 481.073, 481.074, 481.075, 481.076,
192		-	481.0761, 481.0762, 481.0763, 481.0764, 481.0765, [and] 481.0766,
193		-	481.0767, 481.0768, and 481.0769.
194		-	SECTION 6. Section 481.128(a), Health and Safety Code, is
	262	+	481.0755, 481.076, 481.0761, 481.0762, 481.0763, 481.0764,
	263	+	481.0765, [and] 481.0766, 481.0767, 481.0768, and 481.0769. The
	264	+	board may adopt rules to administer Sections 481.073, 481.074,
	265	+	481.075, 481.0755, 481.076, 481.0761, 481.0762, 481.0763,
	266	+	481.0764, 481.0765, [and] 481.0766, 481.0767, 481.0768, and
	267	+	481.0769.
	268	+	SECTION 7. Section 481.128(a), Health and Safety Code, is
195	269		amended to read as follows:
196	270		(a) A registrant or dispenser commits an offense if the
197	271		registrant or dispenser knowingly:
198	272		(1) distributes, delivers, administers, or dispenses
199	273		a controlled substance in violation of Subchapter C [Sections
200	274		481.070-481.075];
201	275		(2) manufactures a controlled substance not
202	276		authorized by the person's Federal Drug Enforcement Administration
203	277		registration or distributes or dispenses a controlled substance not
204	278		authorized by the person's registration to another registrant or
205	279		other person;
206	280		(3) refuses or fails to make, keep, or furnish a
207	281		record, report, notification, order form, statement, invoice, or
208	282		information required by this chapter;
209	283		(4) prints, manufactures, possesses, or produces an
210	284		official prescription form without the approval of the board;
211	285		(5) delivers or possesses a counterfeit official
212	286		prescription form;
213	287		(6) refuses an entry into a premise for an inspection
214	288		authorized by this chapter;
215	289		(7) refuses or fails to return an official
216	290		prescription form as required by Section 481.075(k);
217	291		(8) refuses or fails to make, keep, or furnish a
218	292		record, report, notification, order form, statement, invoice, or
219	293		information required by a rule adopted by the director or the board;
220	294		or
221	295		(9) refuses or fails to maintain security required by
222	296		this chapter or a rule adopted under this chapter.
223		-	SECTION 7. Section 481.129(a), Health and Safety Code, is
	297	+	SECTION 8. Section 481.129(a), Health and Safety Code, is
224	298		amended to read as follows:
225	299		(a) A person commits an offense if the person knowingly:
226	300		(1) distributes as a registrant or dispenser a
227	301		controlled substance listed in Schedule I or II, unless the person
228	302		distributes the controlled substance as authorized under the
229	303		federal Controlled Substances Act (21 U.S.C. Section 801 et seq.);
230	304		(2) uses in the course of manufacturing, prescribing,
231	305		or distributing a controlled substance a Federal Drug Enforcement
232	306		Administration registration number that is fictitious, revoked,
233	307		suspended, or issued to another person;
234	308		(3) issues a prescription bearing a forged or
235	309		fictitious signature;
236	310		(4) uses a prescription issued to another person to
237	311		prescribe a Schedule II controlled substance;
238	312		(5) possesses, obtains, or attempts to possess or
239	313		obtain a controlled substance or an increased quantity of a
240	314		controlled substance:
241	315		(A) by misrepresentation, fraud, forgery,
242	316		deception, or subterfuge;
243	317		(B) through use of a fraudulent prescription
244	318		form; [or]
245	319		(C) through use of a fraudulent oral or
246	320		telephonically communicated prescription; or
247	321		(D) through the use of a fraudulent electronic
248	322		prescription; or
249	323		(6) furnishes false or fraudulent material
250	324		information in or omits material information from an application,
251	325		report, record, or other document required to be kept or filed under
252	326		this chapter.
253		-	SECTION 8. Section 554.051(a-1), Occupations Code, is
	327	+	SECTION 9. Section 554.051(a-1), Occupations Code, is
254	328		amended to read as follows:
255	329		(a-1) The board may adopt rules to administer Sections
256		-	481.073, 481.074, 481.075, 481.076, 481.0761, 481.0762, ~~481.0763,~~
257		-	481.0764, 481.0765, [and] 481.0766, 481.0767, 481.0768, ~~and~~
258		-	481.0769, Health and Safety Code.
259		-	SECTION 9. Section 565.003, Occupations Code, is amended to
260		-	read as follows:
	330	+	481.073, 481.074, 481.075, 481.0755, 481.076, 481.0761, 481.0762,
	331	+	481.0763, 481.0764, 481.0765, [and] 481.0766, 481.0767, 481.0768,
	332	+	and 481.0769, Health and Safety Code.
	333	+	SECTION 10. Section 565.003, Occupations Code, is amended
	334	+	to read as follows:
261	335		Sec. 565.003. ADDITIONAL GROUNDS FOR DISCIPLINE REGARDING
262	336		APPLICANT FOR OR HOLDER OF NONRESIDENT PHARMACY LICENSE. Unless
263	337		compliance would violate the pharmacy or drug statutes or rules in
264	338		the state in which the pharmacy is located, the board may discipline
265	339		an applicant for or the holder of a nonresident pharmacy license if
266	340		the board finds that the applicant or license holder has failed to
267	341		comply with:
268	342		(1) Subchapter C, Chapter 481 [Section 481.074 or
269	343		481.075], Health and Safety Code;
270	344		(2) Texas substitution requirements regarding:
271	345		(A) the practitioner's directions concerning
272	346		generic substitution;
273	347		(B) the patient's right to refuse generic
274	348		substitution; or
275	349		(C) notification to the patient of the patient's
276	350		right to refuse substitution;
277	351		(3) any board rule relating to providing drug
278	352		information to the patient or the patient's agent in written form or
279	353		by telephone; or
280	354		(4) any board rule adopted under Section 554.051(a)
281	355		and determined by the board to be applicable under Section
282	356		554.051(b).
283		-	SECTION 10. Sections 481.076(a-3), (a-4), and (a-5), Health
	357	+	SECTION 11. Sections 481.076(a-3), (a-4), and (a-5), Health
284	358		and Safety Code, are repealed.
285		-	SECTION 11. To the extent of any conflict, this Act prevails
	359	+	SECTION 12. To the extent of any conflict, this Act prevails
286	360		over another Act of the 86th Legislature, Regular Session, 2019,
287	361		relating to nonsubstantive additions to and corrections in enacted
288	362		codes.
289		-	SECTION 12. Notwithstanding Section 24, Chapter 485 (H.B.
	363	+	SECTION 13. Notwithstanding Section 24, Chapter 485 (H.B.
290	364		2561), Acts of the 85th Legislature, Regular Session, 2017, Section
291	365		481.0764(a), Health and Safety Code, as added by that Act, applies
292	366		only to:
293	367		(1) a prescriber, other than a veterinarian, who
294	368		issues a prescription for a controlled substance on or after March
295	369		1, 2020; or
296	370		(2) a person authorized by law to dispense a
297	371		controlled substance, other than a veterinarian, who dispenses a
298	372		controlled substance on or after March 1, 2020.
299		-	SECTION 13. Section 481.0768(a), Health and Safety Code, as
	373	+	SECTION 14. Section 481.0755, Health and Safety Code, as
	374	+	added by this Act, applies only to a prescription issued on or after
	375	+	the effective date of this Act.
	376	+	SECTION 15. Section 481.0768(a), Health and Safety Code, as
300	377		added by this Act, applies only to conduct that occurs on or after
301	378		the effective date of this Act.
302		-	SECTION 14. Section 801.307(a-1), Occupations Code, as
	379	+	SECTION 16. Section 801.307(a-1), Occupations Code, as
303	380		added by this Act, applies only to the renewal of a license to
304	381		practice veterinary medicine on or after September 1, 2020. The
305	382		renewal of a license before that date is governed by the law in
306	383		effect immediately before the effective date of this Act, and the
307	384		former law is continued in effect for that purpose.
308		-	SECTION 15. This Act takes effect September 1, 2019.
309		-	______________________________ ______________________________
310		-	President of the Senate Speaker of the House
311		-	I certify that H.B. No. 3284 was passed by the House on May
312		-	10, 2019, by the following vote: Yeas 136, Nays 3, 1 present, not
313		-	voting; that the House refused to concur in Senate amendments to
314		-	H.B. No. 3284 on May 24, 2019, and requested the appointment of a
315		-	conference committee to consider the differences between the two
316		-	houses; and that the House adopted the conference committee report
317		-	on H.B. No. 3284 on May 26, 2019, by the following vote: Yeas 139,
318		-	Nays 4, 1 present, not voting.
319		-	______________________________
320		-	Chief Clerk of the House
321		-	I certify that H.B. No. 3284 was passed by the Senate, with
322		-	amendments, on May 22, 2019, by the following vote: Yeas 30, Nays
323		-	1; at the request of the House, the Senate appointed a conference
324		-	committee to consider the differences between the two houses; and
325		-	that the Senate adopted the conference committee report on H.B. No.
326		-	3284 on May 26, 2019, by the following vote: Yeas 30, Nays 1.
327		-	______________________________
328		-	Secretary of the Senate
329		-	APPROVED: __________________
330		-	Date
331		-	__________________
332		-	Governor
	385	+	SECTION 17. This Act takes effect September 1, 2019.
	386	+	* * * * *