Texas 2015 - 84th Regular

Texas House Bill HB2271 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1		-	84R23826 JSC-D
2		-	By: Sheffield H.B. No. 2271
3		-	Substitute the following for H.B. No. 2271:
4		-	By: Crownover C.S.H.B. No. 2271
	1	+	By: Sheffield, Davis of Dallas, Zerwas, H.B. No. 2271
	2	+	Klick
5	3
6	4
7	5		A BILL TO BE ENTITLED
8	6		AN ACT
9	7		relating to a pilot program for donation and redistribution of
10	8		certain unused prescription medications; authorizing a fee.
11	9		BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
12	10		SECTION 1. Chapter 431, Health and Safety Code, is amended
13	11		by adding Subchapter O to read as follows:
14	12		SUBCHAPTER O. PRESCRIPTION DRUG DONATION PILOT PROGRAM
15	13		Sec. 431.451. DEFINITIONS. In this subchapter:
16	14		(1) "Charitable drug donor" means:
17	15		(A) a licensed convalescent or nursing facility
18	16		or related institution, licensed hospice, hospital, physician, or
19	17		pharmacy;
20	18		(B) a pharmaceutical seller or manufacturer that
21	19		donates drugs under a qualified patient assistance program; or
22	20		(C) the licensed health care professional
23	21		responsible for administration of drugs in a penal institution, as
24	22		defined by Section 1.07, Penal Code, in this state.
25	23		(2) "Charitable medical clinic" has the meaning
26	24		assigned by Section 431.321.
27	25		(3) "Manufacturer" means a person, other than a
28	26		charitable drug donor, as defined in Chapter 82, Civil Practice and
29	27		Remedies Code.
30	28		(4) "Patient assistance program" means a qualified
31	29		program offered by a pharmaceutical manufacturer under which the
32	30		manufacturer provides drugs to financially disadvantaged persons
33	31		at no charge or at a substantially reduced cost. The term does not
34	32		include the provision of a drug as part of a clinical trial.
35	33		(5) "Pilot program" means the prescription drug
36	34		donation pilot program under this subchapter.
37	35		(6) "Prescription drug" has the meaning assigned by
38	36		Section 551.003, Occupations Code.
39	37		(7) "Seller" means a person, other than a charitable
40	38		drug donor, as defined in Chapter 82, Civil Practice and Remedies
41	39		Code.
42	40		Sec. 431.452. ESTABLISHMENT OF PILOT PROGRAM. (a) The
43	41		department shall establish a pilot program for donation and
44	42		redistribution of prescription drugs under this subchapter.
45	43		(b) The department shall conduct the pilot program in one or
46	44		more municipalities with a population of more than 500,000 but less
47	45		than one million.
48	46		Sec. 431.453. DONATION OF UNUSED DRUGS. (a) A charitable
49	47		drug donor may donate certain unused prescription drugs to the
50	48		department for the pilot program under this subchapter.
51	49		(b) A seller or manufacturer of a drug that donates drugs
52	50		through a qualified patient assistance program is considered a
53	51		charitable drug donor.
54	52		(c) A charitable drug donor shall use appropriate
55	53		safeguards established by department rule to ensure that the drugs
56	54		are not compromised or illegally diverted while being stored or
57	55		transported.
58	56		(d) The department may not accept the donated drugs unless:
59	57		(1) the charitable drug donor certifies that the drugs
60	58		have been properly stored while in the possession of the donor or of
61	59		the person for whom the drugs were originally dispensed;
62	60		(2) the charitable drug donor provides the department
63	61		with a verifiable address and telephone number; and
64	62		(3) the person transferring possession of the drugs
65	63		presents photographic identification.
66	64		Sec. 431.454. CIRCUMSTANCES UNDER WHICH DONATED DRUGS MAY
67	65		BE ACCEPTED. (a) The department may accept donated drugs only in
68	66		accordance with this subchapter.
69	67		(b) The donated drugs must be:
70	68		(1) prescription drugs; and
71	69		(2) approved by the federal Food and Drug
72	70		Administration and:
73	71		(A) sealed in unopened tamper-evident unit dose
74	72		packaging;
75	73		(B) be oral medication in sealed single-dose
76	74		containers approved by the federal Food and Drug Administration; or
77	75		(C) be topical or inhalant drugs in sealed
78	76		units-of-use containers approved by the federal Food and Drug
79	77		Administration.
80	78		(c) A drug packaged in single unit doses may be accepted and
81	79		distributed if the outside packaging is opened but the single unit
82	80		dose packaging is unopened.
83	81		(d) Donated drugs may not:
84	82		(1) be the subject of a mandatory recall by a state or
85	83		federal agency or a voluntary recall by a drug seller or
86	84		manufacturer;
87	85		(2) be adulterated or misbranded;
88	86		(3) be a controlled substance under Chapter 481;
89	87		(4) be a parenteral or injectable medication;
90	88		(5) require refrigeration; or
91	89		(6) expire less than 60 days after the date of the
92	90		donation.
93	91		(e) The department may distribute the donated drugs only
94	92		after a licensed pharmacist has determined that the drugs are of an
95	93		acceptable integrity.
96	94		(f) The department may not charge a fee for the drugs
97	95		donated under the pilot program other than a nominal handling fee to
98	96		defray the costs incurred in implementing the pilot program under
99	97		this subchapter.
100	98		(g) The department may not resell the drugs donated under
101	99		the pilot program.
102	100		Sec. 431.455. PRESCRIPTION, PROVISION, AND ADMINISTRATION
103	101		OF DONATED DRUGS. (a) The donated drugs may be accepted and
104	102		provided or administered to patients only by:
105	103		(1) a charitable medical clinic;
106	104		(2) a physician's office using the drugs for patients
107	105		who receive assistance from the medical assistance program under
108	106		Chapter 32, Human Resources Code, or for other indigent health
109	107		care; or
110	108		(3) a licensed health care professional responsible
111	109		for administration of drugs in a penal institution, as defined by
112	110		Section 1.07, Penal Code, in this state.
113	111		(b) A prescription drug provided or administered to a
114	112		patient under the pilot program must be prescribed by a
115	113		practitioner for use by that patient.
116	114		(c) The clinic or physician providing or administering the
117	115		drug may charge a nominal handling fee in an amount prescribed by
118	116		department rule.
119	117		(d) A clinic, physician, or other licensed health care
120	118		professional receiving donated drugs may not resell the drugs.
121	119		Sec. 431.456. CENTRAL DRUG REPOSITORY. The department
122	120		shall establish a location to centrally store drugs donated under
123	121		this subchapter for distribution to qualifying recipients.
124	122		Sec. 431.457. DATABASE OF DONATED DRUGS. The department
125	123		shall establish and maintain an electronic database in which:
126	124		(1) the department shall list the name and quantity of
127	125		each drug donated to the department under the pilot program; and
128	126		(2) a charitable medical clinic, physician, or other
129	127		licensed health care professional may search for and request
130	128		donated drugs.
131	129		Sec. 431.458. RULES. This subchapter shall be governed by
132	130		department rules that are designed to protect the public health and
133	131		safety, including:
134	132		(1) the maximum handling fee that may be imposed by a
135	133		clinic or physician providing or administering a donated drug to a
136	134		patient;
137	135		(2) provisions for maintenance of the database of
138	136		donated drugs; and
139	137		(3) any necessary forms for the administration of the
140	138		pilot program.
141	139		Sec. 431.459. LIMITATION ON CIVIL AND CRIMINAL LIABILITY.
142	140		(a) Charitable drug donors, manufacturers and sellers of donated
143	141		drugs, charitable medical clinics, physicians, penal institutions,
144	142		and their employees acting in good faith in providing or
145	143		administering prescription drugs under the pilot program are not
146	144		civilly or criminally liable or subject to professional
147	145		disciplinary action for harm caused by providing or administering
148	146		drugs donated under this subchapter unless the harm is caused by:
149	147		(1) wilful or wanton acts of negligence;
150	148		(2) conscious indifference or reckless disregard for
151	149		the safety of others; or
152	150		(3) intentional conduct.
153	151		(b) This section does not apply if the harm results from the
154	152		failure to comply with the requirements of this subchapter.
155	153		(c) This section does not apply to a charitable medical
156	154		clinic that fails to comply with the insurance provisions of
157	155		Chapter 84, Civil Practice and Remedies Code.
158	156		Sec. 431.460. REPORTS TO LEGISLATURE. Not later than
159	157		January 1 of each odd-numbered year, the department shall report to
160	158		the legislature on the results of the pilot program. The report
161	159		must include:
162	160		(1) the pilot program's efficacy in expanding access
163	161		to prescription medications;
164	162		(2) any cost savings to the state or local governments
165	163		resulting from or projected to result from the pilot program;
166	164		(3) an evaluation of the pilot program's database and
167	165		system of distribution;
168	166		(4) any health and safety issues posed by providing or
169	167		administering donated drugs;
170	168		(5) recommendations on improvements to the pilot
171	169		program; and
172	170		(6) an evaluation of potential expansion of the pilot
173	171		program.
174		-	SECTION 2. Not later than December 1, 2015, the Department
	172	+	SECTION 2. (a) As soon as practicable after the effective
	173	+	date of this Act, the Department of State Health Services shall
	174	+	conduct a study to determine the feasibility of establishing a
	175	+	program under which:
	176	+	(1)
	177	+	a hospital, a nursing facility, or another health
	178	+	facility may transfer to the department, or an entity designated by
	179	+	the department, for no payment, unused drugs that the hospital,
	180	+	nursing facility, or health facility received reimbursement for the
	181	+	cost of under Medicaid; and
	182	+	(2) the department, or the entity designated by the
	183	+	department, distributes to public hospitals the unused drugs
	184	+	transferred to the department or entity under Subdivision (1) of
	185	+	this subsection.
	186	+	(b) In conducting the study under Subsection (a) of this
	187	+	section, the Department of State Health Services shall consider the
	188	+	rules the executive commissioner of the Health and Human Services
	189	+	Commission may need to adopt to implement the program described in
	190	+	Subsection (a) of this section, including rules that provide for:
	191	+	(1) the types of unused drugs that may be transferred
	192	+	to the department or an entity designated by the department;
	193	+	(2) the procedures for transferring unused drugs to
	194	+	the department or the entity designated by the department;
	195	+	(3) the procedures for allocating and distributing the
	196	+	unused drugs to public hospitals; and
	197	+	(4) the qualifications for an entity to be designated
	198	+	by the department to receive and distribute unused drugs under the
	199	+	program, including demonstrated expertise in handling, storing,
	200	+	and assessing prescription and nonprescription drugs and
	201	+	coordinating with the state's public hospital system.
	202	+	(c) Not later than September 1, 2016, the Department of
	203	+	State Health Services shall submit to the legislature a report
	204	+	containing the findings of the study conducted under Subsection (a)
	205	+	of this section.
	206	+	SECTION 3. Not later than December 1, 2015, the Department
175	207		of State Health Services shall establish the central repository and
176	208		database required by Subchapter O, Chapter 431, Health and Safety
177	209		Code, as added by this Act.
178		-	SECTION 3. The change in law made by this Act applies only
	210	+	SECTION 4. The change in law made by this Act applies only
179	211		to a drug that is donated, accepted, provided, or administered on or
180	212		after January 1, 2016.
181		-	SECTION 4. This Act takes effect September 1, 2015.
	213	+	SECTION 5. This Act takes effect September 1, 2015.