Rhode Island 2023 Regular Session

Rhode Island Senate Bill S0570 Compare Versions

Only one version of the bill is available at this time.

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5	5	2023 -- S 0570
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9	9	S TATE OF RHODE IS LAND
10	10	IN GENERAL ASSEMBLY
11	11	JANUARY SESSION, A.D. 2023
12	12	____________
13	13
14	14	A N A C T
15	15	RELATING TO HEALTH AND SAFETY -- PREVENTION AND SUPPR ESSION OF
16	16	CONTAGIOUS DISEASES -- HIV/AIDS
17	17	Introduced By: Senators Miller, Valverde, Sosnowski, DiMario, Lawson, Mack, Euer,
18	18	Lauria, and Murray
19	19	Date Introduced: March 07, 2023
20	20	Referred To: Senate Health & Human Services
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23	23	It is enacted by the General Assembly as follows:
24	24	SECTION 1. Chapter 23-6.3 of the General Laws entitled "Prevention and Suppression of 1
25	25	Contagious Diseases — HIV/AIDS" is hereby amended by adding thereto the following section: 2
26	26	23-6.3-20. HIV prevention drug. 3
27	27	(a) A licensed pharmacist may prescribe, dispense or administer HIV prevention drugs in 4
28	28	accordance with rules and regulations promulgated by the department of health in accordance with 5
29	29	this section. 6
30	30	(b) A licensed pharmacist may prescribe, dispense or administer HIV prevention drugs 7
31	31	according to the United States Food and Drug Administration guidance and product labeling if the 8
32	32	patient: 9
33	33	(1) Is HIV negative, as documented by a negative HIV test result obtained within the 10
34	34	previous seven (7) days from an HIV antigen and antibody test or antibody-only test or from a 11
35	35	rapid, point-of-care fingerstick blood test approved by the United States Food and Drug 12
36	36	Administration; provided, however, that if the patient does not provide evidence of a negative HIV 13
37	37	test in accordance with this subsection, the pharmacist may order an HIV test prior to prescribing, 14
38	38	dispensing or administering the drugs; provided further, that if the test results are not transmitted 15
39	39	directly to the pharmacist, the pharmacist shall verify the test results to the pharmacist’s satisfaction 16
40	40	prior to prescribing, dispensing or administering the drugs; and provided further, that if the patient 17
41	41	tests positive for HIV infection, the pharmacist or person administering the test shall direct the 18
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45	45	patient to a primary care provider and provide the patient with a list of providers and clinics in the 1
46	46	region; 2
47	47	(2) Does not report any signs or symptoms of acute HIV infection on a self-reported 3
48	48	checklist of acute HIV infection signs and symptoms; and 4
49	49	(3) Does not report taking any contraindicated medication. 5
50	50	(c) A licensed pharmacist that prescribes, dispenses or administers HIV prevention drugs 6
51	51	shall: 7
52	52	(1) Provide counseling to the patient on the ongoing use of pre-exposure prophylaxis, 8
53	53	which may include education about side effects, safety during pregnancy and breastfeeding, 9
54	54	adherence to recommended dosing and the importance of timely testing and treatment, as 10
55	55	applicable, for HIV, renal function, hepatitis B, hepatitis C, sexually transmitted infections and 11
56	56	pregnancy for individuals of child-bearing capacity; 12
57	57	(2) Notify the patient that the patient is required to be seen by a primary care provider to 13
58	58	receive subsequent prescriptions for pre-exposure prophylaxis and that a pharmacist shall not 14
59	59	furnish a sixty (60) day supply of pre-exposure prophylaxis to a single patient more than once every 15
60	60	two (2) years; 16
61	61	(3) Document, to the extent possible, the services provided to the patient by the pharmacist 17
62	62	in the patient’s record in the record system maintained by the pharmacy and maintain records of 18
63	63	pre-exposure prophylaxis furnished to each patient; and 19
64	64	(4) Notify the patient’s primary care provider that the pharmacist completed the 20
65	65	requirements specified in this subsection; provided, however, that if the patient does not have a 21
66	66	primary care provider or refuses to consent to notify the patient’s primary care provider, the 22
67	67	pharmacist shall provide the patient a list of physicians and surgeons, clinics or other health care 23
68	68	service providers to contact regarding ongoing care for pre-exposure prophylaxis. 24
69	69	(d) The department of health shall promulgate rules and regulations to establish statewide 25
70	70	drug therapy protocols for prescribing, dispensing and administering pre-exposure prophylaxis and 26
71	71	other HIV prevention drugs approved by the United States Food and Drug Administration that are 27
72	72	consistent with federal Centers for Disease Control and Prevention guidelines not later than six (6) 28
73	73	months after the effective date of this section. The regulations shall include, but not be limited to, 29
74	74	rules stating that a pharmacist shall not furnish a sixty (60) day supply of pre-exposure prophylaxis 30
75	75	to a single patient more than once every two (2) years. 31
76	76	SECTION 2. Section 23-6.3-2 of the General Laws in Chapter 23-6.3 entitled "Prevention 32
77	77	and Suppression of Contagious Diseases — HIV/AIDS" is hereby amended to read as follows: 33
78	78	23-6.3-2. Definitions. 34
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82	82	As used in this chapter the following words shall have the following meanings: 1
83	83	(1) “Agent” means a person empowered by the patient to assert or waive the confidentiality, 2
84	84	or to disclose or consent to the disclosure of confidential information, as established by chapter 3
85	85	37.3 of title 5, as amended, entitled “Confidentiality of Health Care Communications and 4
86	86	Information Act.” 5
87	87	(2) “AIDS” means the medical condition known as acquired immune deficiency syndrome, 6
88	88	caused by infection of an individual by the human immunodeficiency virus (HIV). 7
89	89	(3) “Anonymous HIV testing” means an HIV test that utilizes a laboratory generated code 8
90	90	based system, which does not require an individual’s name or other identifying information that 9
91	91	may reveal one’s identity, including information related to the individual’s health insurance policy, 10
92	92	to be associated with the test. 11
93	93	(4) “Antibody” means a protein produced by the body in response to specific foreign 12
94	94	substances such as bacteria or viruses. 13
95	95	(5) “Community-based organization” means an entity that has written authorization from 14
96	96	the department for HIV counseling, testing and referral services (HIV CTRS). 15
97	97	(6) “Confidential HIV testing” means an HIV test that requires the individual’s name and 16
98	98	other identifying information including information related to the individual’s health insurance 17
99	99	policy, as appropriate. 18
100	100	(7) “Consent” means an explicit exchange of information between a person and a 19
101	101	healthcare provider or qualified professional HIV test counselor through which an informed 20
102	102	individual can choose whether to undergo HIV testing or decline to do so. Elements of consent 21
103	103	shall include providing each individual with verbal or written information regarding an explanation 22
104	104	of HIV infection, a description of interventions that can reduce HIV transmission, the meanings of 23
105	105	positive and negative test results, the voluntary nature of the HIV testing, an opportunity to ask 24
106	106	questions and to decline testing. 25
107	107	(8) “Controlled substance” means a drug, substance, or immediate precursor in schedules 26
108	108	I-V listed in the provisions of chapter 28 of title 21 entitled, “Uniform Controlled Substances Act.” 27
109	109	(9) “Department” means the Rhode Island department of health. 28
110	110	(10) “Diagnosis of AIDS” means the most current surveillance case definition for AIDS 29
111	111	published in the Centers for Disease Control & Prevention (CDC). 30
112	112	(11) “Diagnosis of HIV” means the most current surveillance case definition for HIV 31
113	113	infection published in the CDC’s (MMWR). 32
114	114	(12) “Director” means the director of the Rhode Island department of health. 33
115	115	(13) “ELISA result” means enzyme-linked immunosorbent assay or EIA (enzyme 34
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119	119	immunoassay) which is a serologic technique used in immunology to detect the presence of either 1
120	120	antibody or antigen. 2
121	121	(14) “Health benefits” include accident and sickness, including disability or health 3
122	122	insurance, health benefit plans and/or policies, hospital, health, or medical service plans, or any 4
123	123	health maintenance organization plan pursuant to title 27 or otherwise. 5
124	124	(15) “Healthcare facility” means those facilities licensed by the department in accordance 6
125	125	with the provisions of chapter 17 of this title. 7
126	126	(16) “Healthcare provider,” as used herein, means a licensed physician, physician assistant, 8
127	127	certified nurse practitioner or midwife. 9
128	128	(17) “Healthcare settings” means venues offering clinical STD services including, but not 10
129	129	limited to, hospitals, urgent care clinics, STD clinics and other substance abuse treatment facilities, 11
130	130	mental health treatment facilities, community health centers, primary care and OB/GYN physician 12
131	131	offices, and family planning providers. 13
132	132	(18) “HIV” means the human immunodeficiency virus, the pathogenic organism 14
133	133	responsible for HIV infection and/or the acquired immunodeficiency syndrome (AIDS) in humans. 15
134	134	(19) “HIV CD4 T-lymphocyte test result” means the results of any currently medically 16
135	135	accepted and/or FDA approved test used to count CD4 T-lymphatic cells in the blood of an HIV-17
136	136	infected person. 18
137	137	(20) “HIV counseling” means an interactive process of communication between a person 19
138	138	and a healthcare provider or qualified professional HIV test counselor during which there is an 20
139	139	assessment of the person’s risks for HIV infection and the provision of counseling to assist the 21
140	140	person with behavior changes that can reduce risks for acquiring HIV infection. 22
141	141	(21) “HIV prevention drug” means a drug approved by the United States Food and Drug 23
142	142	Administration for the prevention of HIV, including, but not limited to, pre-exposure prophylaxis. 24
143	143	(22) “HIV screening” means the conduct of HIV testing among those who do not show 25
144	144	signs or symptoms of an HIV infection. 26
145	145	(22)(23) “HIV test” means any currently medically accepted and/or FDA approved test for 27
146	146	determining HIV infection in humans. 28
147	147	(23)(24) “Occupational health representative” means a person, within a healthcare facility, 29
148	148	trained to respond to occupational, particularly blood borne, exposures. 30
149	149	(24)(25) “Opts out” means that a person who has been notified that a voluntary HIV test 31
150	150	will be performed, has elected to decline or defer testing. Consent to HIV testing is inferred unless 32
151	151	the individual declines testing. 33
152	152	(25)(26) “Perinatal case report for HIV” means the information that is provided to the 34
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156	156	department related to a child aged less than eighteen (18) months born to an HIV-infected mother 1
157	157	and the child does not meet the criteria for HIV infection or the criteria for “not infected” with HIV 2
158	158	as defined in the most current surveillance case definition for HIV infection published by the CDC. 3
159	159	(26)(27) “Person” means any individual, trust or estate, partnership, corporation (including 4
160	160	associations, joint stock companies), limited liability companies, state, or political subdivision or 5
161	161	instrumentality of a state. 6
162	162	(27)(28) “Persons at high risk for HIV infection” means persons defined as being high risk 7
163	163	in the CDC’s most current recommendations for HIV testing of adults, adolescents and pregnant 8
164	164	women in healthcare settings or through authority and responsibilities conferred on the director by 9
165	165	law in protecting the public’s health. 10
166	166	(28)(29) “Polymerase chain reaction (PCR) test” means a common laboratory method of 11
167	167	creating copies of specific fragments of DNA or RNA. 12
168	168	(29)(30) “Pre-exposure prophylaxis” means a drug or drug combination that is taken or 13
169	169	administered to reduce the risk of HIV acquisition and meets the same clinical eligibility 14
170	170	recommendations provided in current guidelines of the federal Centers for Disease Control and 15
171	171	Prevention. 16
172	172	(31) “Qualified professional HIV test counselor” means: (i) A physician, physician 17
173	173	assistant, certified nurse practitioner, midwife, or nurse licensed to practice in accordance with 18
174	174	applicable state law; (ii) A medical student who is actively matriculating in a medical degree 19
175	175	program and who performs duties assigned to them by a physician; or (iii) A person who has 20
176	176	completed an HIV counseling training program, in accordance with regulations hereunder 21
177	177	promulgated. 22
178	178	(30)(32) “Sexually transmitted diseases (STD’s)” means those diseases included in § 23-23
179	179	11-1, as amended, entitled “Sexually Transmitted Diseases,” and any other sexually transmitted 24
180	180	disease that may be required to be reported by the department. 25
181	181	SECTION 3. This act shall take effect upon passage. 26
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188	188	EXPLANATION
189	189	BY THE LEGISLATIVE COUNCIL
190	190	OF
191	191	A N A C T
192	192	RELATING TO HEALTH AND SAFETY -- PREVENTION AND SUPPR ESSION OF
193	193	CONTAGIOUS DISEASES -- HIV/AIDS
194	194	***
195	195	This act would permit a licensed pharmacist to prescribe, dispense or administer HIV 1
196	196	prevention drugs once every two (2) years to an individual who is HIV negative, does not report 2
197	197	any signs or symptoms of acute HIV infection, and does not report taking any contraindicated 3
198	198	medication. A licensed pharmacist prescribing, dispensing or administering HIV prevention drugs 4
199	199	shall counsel the individual receiving the drug on the ongoing use of the drug and notify the patient 5
200	200	that they must be seen by a primary care provider to receive subsequent dosages. 6
201	201	This act would take effect upon passage. 7
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