Rhode Island 2023 Regular Session

Rhode Island House Bill H6150 Compare Versions

Version 1 (Old)

Version 2 (New)

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5		-	2023 -- H 6150 ~~SUBSTITUTE A~~
	5	+	2023 -- H 6150
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7		-	LC002548~~/SUB A~~
	7	+	LC002548
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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		-	RELATING TO INSURANCE -- ACCIDENT AND SICKNESS INSURANCE POLICIES
	15	+	RELATING TO INSURANCE -- INSURANCE COVERAGE FOR PREVENT ION OF HIV
	16	+	INFECTION
16	17		Introduced By: Representatives Potter, Baginski, Kazarian, Cruz, Donovan, Kislak,
17	18		Giraldo, McNamara, Voas, and Morales
18	19		Date Introduced: March 10, 2023
19	20		Referred To: House Health & Human Services
20	21
21	22
22	23		It is enacted by the General Assembly as follows:
23		-	SECTION 1. Chapter 27-18 of the General Laws entitled "Accident and Sickness Insurance 1
24		-	Policies" is hereby amended by adding thereto the following section: 2
25		-	27-18-91. Coverage for treatment of pre-exposure prophylaxis (PrEP) for the 3
26		-	prevention of HIV and post-exposure prophylaxis (PEP) to prevent HIV infection. 4
27		-	(a) Every group health insurance contract, or every group hospital or medical expense 5
28		-	insurance policy, plan, or group policy delivered, issued for delivery, or renewed in this state, by 6
29		-	any health insurance carrier, on or after January 1, 2024, shall provide coverage for treatment of 7
30		-	pre-exposure prophylaxis (“PrEP”) for the prevention of HIV and post-exposure prophylaxis 8
31		-	(“PEP”) to prevent HIV infection. 9
32		-	(b) When PrEP or PEP is recommended with a grade of “A” or “B” by the U.S. Preventive 10
33		-	Services Taskforce, then the coverage shall be provided without applying any copayments, 11
34		-	deductibles, coinsurance, or other cost sharing, and medical management shall be limited, in 12
35		-	accordance with the processes outlined in 42 U.S.C. § 300gg-13 and related regulations and 13
36		-	guidance. 14
37		-	(c) Notwithstanding any provision of law to the contrary and as authorized by the Rhode 15
38		-	Island board of pharmacy (the “board”) in accordance with rules and regulations adopted under 16
39		-	subsection (d) of this section, a pharmacist may prescribe, dispense and administer HIV PrEP or 17
40		-	PEP drugs (hereinafter sometimes referred to as “prevention drugs”) as described in subsection (a) 18
41		-	of this section pursuant to a standing order or collaborative practice agreement or to protocols 19
	24	+	SECTION 1. Title 27 of the General Laws entitled "INSURANCE" is hereby amended by 1
	25	+	adding thereto the following chapter: 2
	26	+	CHAPTER 38.3 3
	27	+	INSURANCE COVERAGE FOR PREVENTION OF HIV INFECTION 4
	28	+	27-38.3-1. Coverage for prevention of HIV infection. 5
	29	+	(a) A group health plan and an individual or group health insurance plan shall provide 6
	30	+	coverage for the prevention treatment of HIV infection under the same terms and conditions as that 7
	31	+	coverage is provided for other illnesses and diseases. 8
	32	+	(b) Coverage for the prevention treatment of HIV infection shall not impose any annual or 9
	33	+	lifetime dollar limitation. 10
	34	+	(c) Financial requirements and quantitative treatment limitations on coverage for the 11
	35	+	prevention treatment of HIV infection shall be no more restrictive than the predominant financial 12
	36	+	requirements applied to substantially all coverage for medical conditions in each treatment 13
	37	+	classification. 14
	38	+	(d) Coverage shall not impose non-quantitative treatment limitations for the prevention 15
	39	+	treatment of HIV infection unless the processes, strategies, evidentiary standards, or other factors 16
	40	+	used in applying the non-quantitative treatment limitation, as written and in operation, are 17
	41	+	comparable to, and are applied no more stringently than, the processes, strategies, evidentiary 18
42	42
43	43
44		-	LC002548/SUB A - Page 2 of 11
45		-	developed by the board for when there is no prescription drug order, standing order or collaborative 1
46		-	practice agreement in accordance with the requirements in this subsection and may also order 2
47		-	laboratory testing for HIV infection as necessary. 3
48		-	(1) Before furnishing an HIV PrEP or PEP drug to a patient, a pharmacist shall complete a 4
49		-	training program approved by the board on the use of protocols developed by the board for 5
50		-	prescribing, dispensing and administering an HIV prevention drug, on the requirements for any 6
51		-	laboratory testing for HIV infection and on guidelines for prescription adherence and best practices 7
52		-	to counsel patients prescribed an HIV prevention drug. 8
53		-	(2) A pharmacist shall dispense or administer a PrEP or PEP drug in at least a thirty (30) 9
54		-	day supply, and up to a sixty (60) day supply, as long as all of the following conditions are met: 10
55		-	(i) The patient tests negative for HIV infection, as documented by a negative HIV test result 11
56		-	obtained within the previous seven (7) days. If the patient does not provide evidence of a negative 12
57		-	HIV test result, the pharmacist shall order an HIV test. If the test results are not transmitted directly 13
58		-	to the pharmacist, the pharmacist shall verify the test results to the pharmacist's satisfaction. If the 14
59		-	patient tests positive for HIV infection, the pharmacist or person administering the test shall direct 15
60		-	the patient to a primary care provider and provide a list of primary care providers and clinics within 16
61		-	a reasonable travel distance of the patient's residence; 17
62		-	(ii) The patient does not report any signs or symptoms of acute HIV infection on a self-18
63		-	reporting checklist of acute HIV infection signs and symptoms; 19
64		-	(iii) The patient does not report taking any contraindicated medications; 20
65		-	(iv) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 21
66		-	the ongoing use of a PrEP or PEP drug. The pharmacist shall notify the patient that the patient shall 22
67		-	be seen by a primary care provider to receive subsequent prescriptions for a PrEP or PEP drug and 23
68		-	that a pharmacist shall not dispense or administer more than a sixty (60) day supply of a PrEP or 24
69		-	PEP drug to a single patient once every two (2) years without a prescription; 25
70		-	(v) The pharmacist documents, to the extent possible, the services provided by the 26
	44	+	LC002548 - Page 2 of 8
	45	+	standards, or other factors used in applying the limitation with respect to medical/surgical benefits 1
	46	+	in the classification. 2
	47	+	(e) The following classifications shall be used to apply the coverage requirements of this 3
	48	+	chapter: 4
	49	+	(1) Inpatient, in-network; 5
	50	+	(2) Inpatient, out-of-network; 6
	51	+	(3) Outpatient, in-network; 7
	52	+	(4) Outpatient, out-of-network; 8
	53	+	(5) Emergency care; and 9
	54	+	(6) Prescription drugs. 10
	55	+	(f) Payors shall rely upon the criteria of the Society of Infectious Diseases Pharmacists 11
	56	+	when developing coverage for levels of care for HIV prevention treatment. 12
	57	+	27-38.3-2. Definitions. 13
	58	+	As used in this section, unless the context otherwise indicates, the following terms have 14
	59	+	the following meanings: 15
	60	+	(1) "CDC guidelines" means guidelines related to the nonoccupational exposure to 16
	61	+	potential HIV infection, or any subsequent guidelines, published by the federal Department of 17
	62	+	Health and Human Services, Centers for Disease Control and Prevention. 18
	63	+	(2) "Financial requirements" means deductibles, copayments, coinsurance, or out-of-19
	64	+	pocket maximums. 20
	65	+	(3) "Group health plan" means an employee welfare benefit plan as defined in 29 U.S.C. § 21
	66	+	1002(1) to the extent that the plan provides health benefits to employees or their dependents directly 22
	67	+	or through insurance, reimbursement, or otherwise. For purposes of this chapter, a group health 23
	68	+	plan shall not include a plan that provides health benefits directly to employees or their dependents, 24
	69	+	except in the case of a plan provided by the state or an instrumentality of the state. 25
	70	+	(4) "Health insurance plan" means health insurance coverage offered, delivered, issued for 26
	71	+	delivery, or renewed by a health insurer. 27
	72	+	(5) "Health insurers" means all persons, firms, corporations, or other organizations offering 28
	73	+	and assuring health services on a prepaid or primarily expense-incurred basis, including, but not 29
	74	+	limited to, policies of accident or sickness insurance, as defined by chapter 18 of this title; nonprofit 30
	75	+	hospital or medical service plans, whether organized under chapter 19 or 20 of this title or under 31
	76	+	any public law or by special act of the general assembly; health maintenance organizations, or any 32
	77	+	other entity that insures or reimburses for diagnostic, therapeutic, or preventive services to a 33
	78	+	determined population on the basis of a periodic premium. Provided, this chapter does not apply to 34
	79	+
	80	+
	81	+	LC002548 - Page 3 of 8
	82	+	insurance coverage providing benefits for: 1
	83	+	(i) Hospital confinement indemnity; 2
	84	+	(ii) Disability income; 3
	85	+	(iii) Accident only; 4
	86	+	(iv) Long-term care; 5
	87	+	(v) Medicare supplement; 6
	88	+	(vi) Limited benefit health; 7
	89	+	(vii) Specific disease indemnity; 8
	90	+	(viii) Sickness or bodily injury or death by accident or both; and 9
	91	+	(ix) Other limited benefit policies. 10
	92	+	(6) "HIV prevention drug" means a preexposure prophylaxis drug, post-exposure 11
	93	+	prophylaxis drug or other drug approved for the prevention of HIV infection by the federal Food 12
	94	+	and Drug Administration. 13
	95	+	(7) "Non-quantitative treatment limitations" means: 14
	96	+	(i) Medical management standards; 15
	97	+	(ii) Formulary design and protocols; 16
	98	+	(iii) Network tier design; 17
	99	+	(iv) Standards for provider admission to participate in a network; 18
	100	+	(v) Reimbursement rates and methods for determining usual, customary, and reasonable 19
	101	+	charges; and 20
	102	+	(vi) Other criteria that limit scope or duration of coverage for services in the prevention 21
	103	+	treatment of HIV infection, including restrictions based on geographic location, facility type, and 22
	104	+	provider specialty. 23
	105	+	(8) "Post-exposure prophylaxis drug" means a drug or drug combination that meets the 24
	106	+	clinical eligibility recommendations provided in CDC guidelines following potential exposure to 25
	107	+	HIV infection. 26
	108	+	(9) "Preexposure prophylaxis drug" means a drug or drug combination that meets the 27
	109	+	clinical eligibility recommendations provided in CDC guidelines to prevent HIV infection. 28
	110	+	(10) "Quantitative treatment limitations" means numerical limits on coverage for the 29
	111	+	preventive treatment of HIV infection based on the frequency of treatment, number of visits, days 30
	112	+	of coverage, days in a waiting period, or other similar limits on the scope or duration of treatment. 31
	113	+	27-38.3-3. Coverage required. 32
	114	+	A health insurer offering a health plan in this state shall provide coverage for an HIV 33
	115	+	prevention drug that has been prescribed by a provider. Coverage under this section is subject to 34
	116	+
	117	+
	118	+	LC002548 - Page 4 of 8
	119	+	the following; 1
	120	+	(1) If the federal Food and Drug Administration has approved one or more HIV prevention 2
	121	+	drugs that use the same method of administration, a health insurer is not required to cover all 3
	122	+	approved drugs as long as the insurer covers at least one approved drug for each method of 4
	123	+	administration with no out-of-pocket cost. 5
	124	+	(2) A health insurer is not required to cover any preexposure prophylaxis drug or post-6
	125	+	exposure prophylaxis drug dispensed or administered by an out-of-network pharmacy provider 7
	126	+	unless the enrollee's health plan provides an out-of-network pharmacy benefit. 8
	127	+	(3) A health insurer shall not prohibit or permit a pharmacy benefits manager to prohibit a 9
	128	+	pharmacy provider from dispensing or administering any HIV prevention drugs. 10
	129	+	27-38.3-4. Limits on prior authorization and step therapy requirements. 11
	130	+	Notwithstanding any requirements to the contrary, a health insurer shall not subject any 12
	131	+	HIV prevention drug to any prior authorization or step therapy requirement except as provided in 13
	132	+	this section. If the federal Food and Drug Administration has approved one or more methods of 14
	133	+	administering HIV prevention drugs, an insurer is not required to cover all of the approved drugs 15
	134	+	without prior authorization or step therapy requirements as long as the insurer covers at least one 16
	135	+	approved drug for each method of administration without prior authorization or step therapy 17
	136	+	requirements. If prior authorization or step therapy requirements are met for a particular enrollee 18
	137	+	with regard to a particular HIV prevention drug, the insurer is required to cover that drug with no 19
	138	+	out-of-pocket cost to the enrollee. 20
	139	+	27-38.3-5. Coverage for laboratory testing related to HIV prevention drugs. 21
	140	+	A health insurer offering a health plan in this state shall provide coverage with no out-of-22
	141	+	pocket cost for laboratory testing recommended by a provider related to the ongoing monitoring of 23
	142	+	an enrollee who is taking an HIV prevention drug covered by this chapter. 24
	143	+	27-38.3-6. Medical necessity and appropriateness of treatment. 25
	144	+	(a) Upon request of the reimbursing health insurers, all providers of prevention treatment 26
	145	+	of HIV infection shall furnish medical records or other necessary data which substantiates that 27
	146	+	initial or continued treatment is at all times medically necessary and/or appropriate. When the 28
	147	+	provider cannot establish the medical necessity and/or appropriateness of the treatment modality 29
	148	+	being provided, neither the health insurer nor the patient shall be obligated to reimburse for that 30
	149	+	period or type of care that was not established. Exception to the preceding requirement can only be 31
	150	+	made if the patient has been informed of the provisions of this subsection and has agreed in writing 32
	151	+	to continue to receive treatment at their own expense. 33
	152	+	(b) The health insurers, when making the determination of medically necessary and 34
	153	+
	154	+
	155	+	LC002548 - Page 5 of 8
	156	+	appropriate treatment, shall do so in a manner consistent with that used to make the determination 1
	157	+	for the treatment of other diseases or injuries covered under the health insurance policy or 2
	158	+	agreement. 3
	159	+	(c) Any subscriber who is aggrieved by a denial of benefits provided under this chapter 4
	160	+	may appeal a denial in accordance with the rules and regulations promulgated by the department 5
	161	+	of health pursuant to chapter 17.12 of title 23. 6
	162	+	27-38.3-7. Network coverage. 7
	163	+	The healthcare benefits outlined in this chapter apply only to services delivered within the 8
	164	+	health insurer’s provider network; provided that, all health insurers shall be required to provide 9
	165	+	coverage for those benefits mandated by this chapter outside of the health insurer’s provider 10
	166	+	network where it can be established that the required services are not available from a provider in 11
	167	+	the health insurer’s network. 12
	168	+	SECTION 2. Chapter 5-19.1 of the General Laws entitled "Pharmacies" is hereby amended 13
	169	+	by adding thereto the following section: 14
	170	+	5-19.1-31.1. Prescribing, dispensing and administering HIV prevention drugs. 15
	171	+	(a) Definitions. As used in this section, unless the context otherwise indicates, the 16
	172	+	following terms have the following meanings. 17
	173	+	(1) "CDC guidelines" means guidelines related to nonoccupational exposure to potential 18
	174	+	HIV infection, or any subsequent guidelines, published by the federal Department of Health and 19
	175	+	Human Services, Centers for Disease Control and Prevention. 20
	176	+	(2) "HIV prevention drug" means a preexposure prophylaxis drug, post-exposure 21
	177	+	prophylaxis drug or other drug approved for the prevention of HIV infection by the federal Food 22
	178	+	and Drug Administration. 23
	179	+	(3) "Post-exposure prophylaxis drug" means a drug or drug combination that meets the 24
	180	+	clinical eligibility recommendations provided in CDC guidelines following potential exposure to 25
	181	+	HIV infection. 26
	182	+	(4) "Preexposure prophylaxis drug" means a drug or drug combination that meets the 27
	183	+	clinical eligibility recommendations provided in CDC guidelines to prevent HIV infection. 28
	184	+	(b) Authorization. Notwithstanding any provision of law to the contrary and as authorized 29
	185	+	by the board in accordance with rules and regulations adopted under subsection (c) of this section, 30
	186	+	a pharmacist may prescribe, dispense and administer HIV prevention drugs pursuant to a standing 31
	187	+	order or collaborative practice agreement or to protocols developed by the board for when there is 32
	188	+	no prescription drug order, standing order or collaborative practice agreement in accordance with 33
	189	+	the requirements in this subsection and may also order laboratory testing for HIV infection as 34
	190	+
	191	+
	192	+	LC002548 - Page 6 of 8
	193	+	necessary. 1
	194	+	(i) Before furnishing an HIV prevention drug to a patient, a pharmacist shall complete a 2
	195	+	training program approved by the board on the use of protocols developed by the board for 3
	196	+	prescribing, dispensing and administering an HIV prevention drug, on the requirements for any 4
	197	+	laboratory testing for HIV infection and on guidelines for prescription adherence and best practices 5
	198	+	to counsel patients prescribed an HIV prevention drug. 6
	199	+	(ii) A pharmacist shall dispense or administer a preexposure prophylaxis drug in at least a 7
	200	+	thirty (30) day supply, and up to a sixty (60) day supply, as long as all of the following conditions 8
	201	+	are met: 9
	202	+	(A) The patient tests negative for HIV infection, as documented by a negative HIV test 10
	203	+	result obtained within the previous seven (7) days. If the patient does not provide evidence of a 11
	204	+	negative HIV test result, the pharmacist shall order an HIV test. If the test results are not transmitted 12
	205	+	directly to the pharmacist, the pharmacist shall verify the test results to the pharmacist's satisfaction. 13
	206	+	If the patient tests positive for HIV infection, the pharmacist or person administering the test shall 14
	207	+	direct the patient to a primary care provider and provide a list of primary care providers and clinics 15
	208	+	within a reasonable travel distance of the patient's residence; 16
	209	+	(B) The patient does not report any signs or symptoms of acute HIV infection on a self-17
	210	+	reporting checklist of acute HIV infection signs and symptoms; 18
	211	+	(C) The patient does not report taking any contraindicated medications; 19
	212	+	(D) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 20
	213	+	the ongoing use of a preexposure prophylaxis drug. The pharmacist shall notify the patient that the 21
	214	+	patient shall be seen by a primary care provider to receive subsequent prescriptions for a 22
	215	+	preexposure prophylaxis drug and that a pharmacist shall not dispense or administer more than a 23
	216	+	sixty (60) day supply of a preexposure prophylaxis drug to a single patient once every two (2) years 24
	217	+	without a prescription; 25
	218	+	(E) The pharmacist documents, to the extent possible, the services provided by the 26
71	219		pharmacist in the patient's record in the patient profile record system maintained by the pharmacy. 27
72		-	The pharmacist shall maintain records of ~~PrEP or PEP~~ drugs dispensed or administered ~~to each~~ 28
73		-	patient; 29
74		-	(vi) The pharmacist does not dispense or administer more than a sixty (60) day supply of a 30
75		-	~~PrEP or PEP~~ drug to a single patient once every two (2) years, unless otherwise directed ~~by a~~ 31
76		-	practitioner; and 32
77		-	(~~vii~~) The pharmacist notifies the patient's primary care provider that the pharmacist 33
	220	+	The pharmacist shall maintain records of preexposure prophylaxis drugs dispensed or administered 28
	221	+	to each patient; 29
	222	+	(F) The pharmacist does not dispense or administer more than a sixty (60) day supply of a 30
	223	+	preexposure prophylaxis drug to a single patient once every two (2) years, unless otherwise directed 31
	224	+	by a practitioner; and 32
	225	+	(G) The pharmacist notifies the patient's primary care provider that the pharmacist 33
78	226		completed the requirements specified in this subsection. If the patient does not have a primary care 34
79	227
80	228
81		-	LC002548~~/SUB A~~ - Page 3 of 11
	229	+	LC002548 - Page 7 of 8
82	230		provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 1
83	231		provide the patient a list of physicians, clinics or other health care providers to contact regarding 2
84	232		follow-up care. 3
85		-	(3) A pharmacist shall dispense or administer a complete course of a post-exposure 4
	233	+	(iii) A pharmacist shall dispense or administer a complete course of a post-exposure 4
86	234		prophylaxis drug as long as all of the following conditions are met: 5
87		-	(i) The pharmacist screens the patient and determines that the exposure occurred within ~~the~~ 6
88		-	previous seventy-two (72) hours and the patient otherwise meets the clinical criteria for a post- 7
	235	+	(A) The pharmacist screens the patient and determines that the exposure occurred within 6
	236	+	the previous seventy-two (72) hours and the patient otherwise meets the clinical criteria for a post-7
89	237		exposure prophylaxis drug under CDC guidelines; 8
90		-	(ii) The pharmacist provides HIV testing to the patient or determines that the patient is 9
	238	+	(B) The pharmacist provides HIV testing to the patient or determines that the patient is 9
91	239		willing to undergo HIV testing consistent with CDC guidelines. If the patient refuses to undergo 10
92	240		HIV testing but is otherwise eligible for a post-exposure prophylaxis drug under this subsection, 11
93	241		the pharmacist may dispense or administer a post-exposure prophylaxis drug; 12
94		-	(~~iii~~) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 13
	242	+	(C) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 13
95	243		the use of a post-exposure prophylaxis drug. The pharmacist shall also inform the patient of the 14
96		-	availability of a PrEP or PEP drug for persons who are at substantial risk of acquiring HIV; and 15
97		-	(iv) The pharmacist notifies the patient's primary care provider of the dispensing or 16
98		-	administering of the post-exposure prophylaxis drug. If the patient does not have a primary care 17
99		-	provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 18
100		-	provide the patient a list of physicians, clinics or other health care providers to contact regarding 19
101		-	follow-up care. 20
102		-	(4) The board shall promulgate rules and regulations establishing standards for authorizing 21
103		-	pharmacists to prescribe, dispense and administer HIV prevention drugs in accordance with this 22
104		-	section, including adequate training requirements and protocols for when there is no prescription 23
105		-	drug order, standing order or collaborative practice agreement. 24
106		-	SECTION 2. Chapter 27-19 of the General Laws entitled "Nonprofit Hospital Service 25
107		-	Corporations" is hereby amended by adding thereto the following section: 26
108		-	27-19-83. Coverage for treatment of pre-exposure prophylaxis (PrEP) for the 27
109		-	prevention of HIV and post-exposure prophylaxis (PEP) to prevent HIV infection. 28
110		-	(a) Every group health insurance contract, or every group hospital or medical expense 29
111		-	insurance policy, plan, or group policy delivered, issued for delivery, or renewed in this state, by 30
112		-	any health insurance carrier, on or after January 1, 2024, shall provide coverage for treatment of 31
113		-	pre- exposure prophylaxis (“PrEP”) for the prevention of HIV and post-exposure prophylaxis 32
114		-	(“PEP”) to prevent HIV infection. 33
115		-	(b) When PrEP or PEP is recommended with a grade of “A” or “B” by the U.S. Preventive 34
116		-
117		-
118		-	LC002548/SUB A - Page 4 of 11
119		-	Services Taskforce, then the coverage shall be provided without applying any copayments, 1
120		-	deductibles, coinsurance, or other cost sharing, and medical management shall be limited, in 2
121		-	accordance with the processes outlined in 42 U.S.C. § 300gg-13 and related regulations and 3
122		-	guidance. 4
123		-	(c) Notwithstanding any provision of law to the contrary and as authorized by the Rhode 5
124		-	Island board of pharmacy (the “board”) in accordance with rules and regulations adopted under 6
125		-	subsection (d) of this section, a pharmacist may prescribe, dispense and administer HIV PrEP or 7
126		-	PEP drugs (hereinafter sometimes referred to as “prevention drugs”) as described in subsection (a) 8
127		-	of this section pursuant to a standing order or collaborative practice agreement or to protocols 9
128		-	developed by the board for when there is no prescription drug order, standing order or collaborative 10
129		-	practice agreement in accordance with the requirements in this subsection and may also order 11
130		-	laboratory testing for HIV infection as necessary. 12
131		-	(1) Before furnishing an HIV PrEP or PEP drug to a patient, a pharmacist shall complete a 13
132		-	training program approved by the board on the use of protocols developed by the board for 14
133		-	prescribing, dispensing and administering an HIV prevention drug, on the requirements for any 15
134		-	laboratory testing for HIV infection and on guidelines for prescription adherence and best practices 16
135		-	to counsel patients prescribed an HIV prevention drug. 17
136		-	(2) A pharmacist shall dispense or administer a PrEP or PEP drug in at least a thirty (30) 18
137		-	day supply, and up to a sixty (60) day supply, as long as all of the following conditions are met: 19
138		-	(i) The patient tests negative for HIV infection, as documented by a negative HIV test result 20
139		-	obtained within the previous seven (7) days. If the patient does not provide evidence of a negative 21
140		-	HIV test result, the pharmacist shall order an HIV test. If the test results are not transmitted directly 22
141		-	to the pharmacist, the pharmacist shall verify the test results to the pharmacist's satisfaction. If the 23
142		-	patient tests positive for HIV infection, the pharmacist or person administering the test shall direct 24
143		-	the patient to a primary care provider and provide a list of primary care providers and clinics within 25
144		-	a reasonable travel distance of the patient's residence; 26
145		-	(ii) The patient does not report any signs or symptoms of acute HIV infection on a self-27
146		-	reporting checklist of acute HIV infection signs and symptoms; 28
147		-	(iii) The patient does not report taking any contraindicated medications; 29
148		-	(iv) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 30
149		-	the ongoing use of a PrEP or PEP drug. The pharmacist shall notify the patient that the patient shall 31
150		-	be seen by a primary care provider to receive subsequent prescriptions for a PrEP or PEP drug and 32
151		-	that a pharmacist shall not dispense or administer more than a sixty (60) day supply of a PrEP or 33
152		-	PEP drug to a single patient once every two (2) years without a prescription; 34
153		-
154		-
155		-	LC002548/SUB A - Page 5 of 11
156		-	(v) The pharmacist documents, to the extent possible, the services provided by the 1
157		-	pharmacist in the patient's record in the patient profile record system maintained by the pharmacy. 2
158		-	The pharmacist shall maintain records of PrEP or PEP drugs dispensed or administered to each 3
159		-	patient; 4
160		-	(vi) The pharmacist does not dispense or administer more than a sixty (60) day supply of a 5
161		-	PrEP or PEP drug to a single patient once every two (2) years, unless otherwise directed by a 6
162		-	practitioner; and 7
163		-	(vii) The pharmacist notifies the patient's primary care provider that the pharmacist 8
164		-	completed the requirements specified in this subsection. If the patient does not have a primary care 9
165		-	provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 10
166		-	provide the patient a list of physicians, clinics or other health care providers to contact regarding 11
167		-	follow-up care. 12
168		-	(3) A pharmacist shall dispense or administer a complete course of a post-exposure 13
169		-	prophylaxis drug as long as all of the following conditions are met: 14
170		-	(i) The pharmacist screens the patient and determines that the exposure occurred within the 15
171		-	previous seventy-two (72) hours and the patient otherwise meets the clinical criteria for a post-16
172		-	exposure prophylaxis drug under CDC guidelines; 17
173		-	(ii) The pharmacist provides HIV testing to the patient or determines that the patient is 18
174		-	willing to undergo HIV testing consistent with CDC guidelines. If the patient refuses to undergo 19
175		-	HIV testing but is otherwise eligible for a post-exposure prophylaxis drug under this subsection, 20
176		-	the pharmacist may dispense or administer a post-exposure prophylaxis drug; 21
177		-	(iii) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 22
178		-	the use of a post-exposure prophylaxis drug. The pharmacist shall also inform the patient of the 23
179		-	availability of a PrEP or PEP drug for persons who are at substantial risk of acquiring HIV; and 24
180		-	(iv) The pharmacist notifies the patient's primary care provider of the dispensing or 25
181		-	administering of the post-exposure prophylaxis drug. If the patient does not have a primary care 26
182		-	provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 27
183		-	provide the patient a list of physicians, clinics or other health care providers to contact regarding 28
184		-	follow-up care. 29
185		-	(4) The board shall promulgate rules and regulations establishing standards for authorizing 30
186		-	pharmacists to prescribe, dispense and administer HIV prevention drugs in accordance with this 31
187		-	section, including adequate training requirements and protocols for when there is no prescription 32
188		-	drug order, standing order or collaborative practice agreement. 33
189		-	SECTION 3. Chapter 27-20 of the General Laws entitled "Nonprofit Medical Service 34
190		-
191		-
192		-	LC002548/SUB A - Page 6 of 11
193		-	Corporations" is hereby amended by adding thereto the following section: 1
194		-	27-20-79. Coverage for treatment of pre-exposure prophylaxis (PrEP) for the 2
195		-	prevention of HIV and post-exposure prophylaxis (PEP) to prevent HIV infection. 3
196		-	(a) Every group health insurance contract, or every group hospital or medical expense 4
197		-	insurance policy, plan, or group policy delivered, issued for delivery, or renewed in this state, by 5
198		-	any health insurance carrier, on or after January 1, 2024, shall provide coverage for treatment of 6
199		-	pre-exposure prophylaxis (“PrEP”) for the prevention of HIV and post-exposure prophylaxis 7
200		-	(“PEP”) to prevent HIV infection. 8
201		-	(b) When PrEP or PEP is recommended with a grade of “A” or “B” by the U.S. Preventive 9
202		-	Services Taskforce, then the coverage shall be provided without applying any copayments, 10
203		-	deductibles, coinsurance, or other cost sharing, and medical management shall be limited, in 11
204		-	accordance with the processes outlined in 42 U.S.C. § 300gg-13 and related regulations and 12
205		-	guidance. 13
206		-	(c) Notwithstanding any provision of law to the contrary and as authorized by the Rhode 14
207		-	Island board of pharmacy (the “board”) in accordance with rules and regulations adopted under 15
208		-	subsection (d) of this section, a pharmacist may prescribe, dispense and administer HIV PrEP or 16
209		-	PEP drugs (hereinafter sometimes referred to as “prevention drugs”) as described in subsection (a) 17
210		-	of this section pursuant to a standing order or collaborative practice agreement or to protocols 18
211		-	developed by the board for when there is no prescription drug order, standing order or collaborative 19
212		-	practice agreement in accordance with the requirements in this subsection and may also order 20
213		-	laboratory testing for HIV infection as necessary. 21
214		-	(1) Before furnishing an HIV PrEP or PEP drug to a patient, a pharmacist shall complete a 22
215		-	training program approved by the board on the use of protocols developed by the board for 23
216		-	prescribing, dispensing and administering an HIV prevention drug, on the requirements for any 24
217		-	laboratory testing for HIV infection and on guidelines for prescription adherence and best practices 25
218		-	to counsel patients prescribed an HIV prevention drug. 26
219		-	(2) A pharmacist shall dispense or administer a PrEP or PEP drug in at least a thirty (30) 27
220		-	day supply, and up to a sixty (60) day supply, as long as all of the following conditions are met: 28
221		-	(i) The patient tests negative for HIV infection, as documented by a negative HIV test result 29
222		-	obtained within the previous seven (7) days. If the patient does not provide evidence of a negative 30
223		-	HIV test result, the pharmacist shall order an HIV test. If the test results are not transmitted directly 31
224		-	to the pharmacist, the pharmacist shall verify the test results to the pharmacist's satisfaction. If the 32
225		-	patient tests positive for HIV infection, the pharmacist or person administering the test shall direct 33
226		-	the patient to a primary care provider and provide a list of primary care providers and clinics within 34
227		-
228		-
229		-	LC002548/SUB A - Page 7 of 11
230		-	a reasonable travel distance of the patient's residence; 1
231		-	(ii) The patient does not report any signs or symptoms of acute HIV infection on a self-2
232		-	reporting checklist of acute HIV infection signs and symptoms; 3
233		-	(iii) The patient does not report taking any contraindicated medications; 4
234		-	(iv) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 5
235		-	the ongoing use of a PrEP or PEP drug. The pharmacist shall notify the patient that the patient shall 6
236		-	be seen by a primary care provider to receive subsequent prescriptions for a PrEP or PEP drug and 7
237		-	that a pharmacist shall not dispense or administer more than a sixty (60) day supply of a PrEP or 8
238		-	PEP drug to a single patient once every two (2) years without a prescription; 9
239		-	(v) The pharmacist documents, to the extent possible, the services provided by the 10
240		-	pharmacist in the patient's record in the patient profile record system maintained by the pharmacy. 11
241		-	The pharmacist shall maintain records of PrEP or PEP drugs dispensed or administered to each 12
242		-	patient; 13
243		-	(vi) The pharmacist does not dispense or administer more than a sixty (60) day supply of a 14
244		-	PrEP or PEP drug to a single patient once every two (2) years, unless otherwise directed by a 15
245		-	practitioner; and 16
246		-	(vii) The pharmacist notifies the patient's primary care provider that the pharmacist 17
247		-	completed the requirements specified in this subsection. If the patient does not have a primary care 18
	244	+	availability of a preexposure prophylaxis drug for persons who are at substantial risk of acquiring 15
	245	+	HIV; and 16
	246	+	(D) The pharmacist notifies the patient's primary care provider of the dispensing or 17
	247	+	administering of the post-exposure prophylaxis drug. If the patient does not have a primary care 18
248	248		provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 19
249	249		provide the patient a list of physicians, clinics or other health care providers to contact regarding 20
250	250		follow-up care. 21
251		-	(3) A pharmacist shall dispense or administer a complete course of a post-exposure 22
252		-	prophylaxis drug as long as all of the following conditions are met: 23
253		-	(i) The pharmacist screens the patient and determines that the exposure occurred within the 24
254		-	previous seventy-two (72) hours and the patient otherwise meets the clinical criteria for a post-25
255		-	exposure prophylaxis drug under CDC guidelines; 26
256		-	(ii) The pharmacist provides HIV testing to the patient or determines that the patient is 27
257		-	willing to undergo HIV testing consistent with CDC guidelines. If the patient refuses to undergo 28
258		-	HIV testing but is otherwise eligible for a post-exposure prophylaxis drug under this subsection, 29
259		-	the pharmacist may dispense or administer a post-exposure prophylaxis drug; 30
260		-	(iii) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 31
261		-	the use of a post-exposure prophylaxis drug. The pharmacist shall also inform the patient of the 32
262		-	availability of a PrEP or PEP drug for persons who are at substantial risk of acquiring HIV; and 33
263		-	(iv) The pharmacist notifies the patient's primary care provider of the dispensing or 34
264		-
265		-
266		-	LC002548/SUB A - Page 8 of 11
267		-	administering of the post-exposure prophylaxis drug. If the patient does not have a primary care 1
268		-	provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 2
269		-	provide the patient a list of physicians, clinics or other health care providers to contact regarding 3
270		-	follow-up care. 4
271		-	(d) The board shall promulgate rules and regulations establishing standards for authorizing 5
272		-	pharmacists to prescribe, dispense and administer HIV prevention drugs in accordance with this 6
273		-	section, including adequate training requirements and protocols for when there is no prescription 7
274		-	drug order, standing order or collaborative practice agreement. 8
275		-	SECTION 4. Chapter 27-41 of the General Laws entitled "Health Maintenance 9
276		-	Organizations" is hereby amended by adding thereto the following section: 10
277		-	27-41-96. Coverage for treatment of pre-exposure prophylaxis (PrEP) for the 11
278		-	prevention of HIV and post-exposure prophylaxis (PEP) to prevent HIV infection. 12
279		-	(a) Every group health insurance contract, or every group hospital or medical expense 13
280		-	insurance policy, plan, or group policy delivered, issued for delivery, or renewed in this state, by 14
281		-	any health insurance carrier, on or after January 1, 2024, shall provide coverage for treatment of 15
282		-	pre-exposure prophylaxis (“PrEP”) for the prevention of HIV and post-exposure prophylaxis 16
283		-	(“PEP”) to prevent HIV infection. 17
284		-	(b) When PrEP or PEP is recommended with a grade of “A” or “B” by the U.S. Preventive 18
285		-	Services Taskforce, then the coverage shall be provided without applying any copayments, 19
286		-	deductibles, coinsurance, or other cost sharing, and medical management shall be limited, in 20
287		-	accordance with the processes outlined in 42 U.S.C. § 300gg-13 and related regulations and 21
288		-	guidance. 22
289		-	(c) Notwithstanding any provision of law to the contrary and as authorized by the Rhode 23
290		-	Island board of pharmacy (the “board”) in accordance with rules and regulations adopted under 24
291		-	subsection (d) of this section, a pharmacist may prescribe, dispense and administer HIV PrEP or 25
292		-	PEP drugs (hereinafter sometimes referred to as “prevention drugs”) as described in subsection (a) 26
293		-	of this section pursuant to a standing order or collaborative practice agreement or to protocols 27
294		-	developed by the board for when there is no prescription drug order, standing order or collaborative 28
295		-	practice agreement in accordance with the requirements in this subsection and may also order 29
296		-	laboratory testing for HIV infection as necessary. 30
297		-	(1) Before furnishing an HIV PrEP or PEP drug to a patient, a pharmacist shall complete a 31
298		-	training program approved by the board on the use of protocols developed by the board for 32
299		-	prescribing, dispensing and administering an HIV prevention drug, on the requirements for any 33
300		-	laboratory testing for HIV infection and on guidelines for prescription adherence and best practices 34
301		-
302		-
303		-	LC002548/SUB A - Page 9 of 11
304		-	to counsel patients prescribed an HIV prevention drug. 1
305		-	(2) A pharmacist shall dispense or administer a PrEP or PEP drug in at least a thirty (30) 2
306		-	day supply, and up to a sixty (60) day supply, as long as all of the following conditions are met: 3
307		-	(i) The patient tests negative for HIV infection, as documented by a negative HIV test result 4
308		-	obtained within the previous seven (7) days. If the patient does not provide evidence of a negative 5
309		-	HIV test result, the pharmacist shall order an HIV test. If the test results are not transmitted directly 6
310		-	to the pharmacist, the pharmacist shall verify the test results to the pharmacist's satisfaction. If the 7
311		-	patient tests positive for HIV infection, the pharmacist or person administering the test shall direct 8
312		-	the patient to a primary care provider and provide a list of primary care providers and clinics within 9
313		-	a reasonable travel distance of the patient's residence; 10
314		-	(ii) The patient does not report any signs or symptoms of acute HIV infection on a self-11
315		-	reporting checklist of acute HIV infection signs and symptoms; 12
316		-	(iii) The patient does not report taking any contraindicated medications; 13
317		-	(iv) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 14
318		-	the ongoing use of a PrEP or PEP drug. The pharmacist shall notify the patient that the patient shall 15
319		-	be seen by a primary care provider to receive subsequent prescriptions for a PrEP or PEP drug and 16
320		-	that a pharmacist shall not dispense or administer more than a sixty (60) day supply of a PrEP or 17
321		-	PEP drug to a single patient once every two (2) years without a prescription; 18
322		-	(v) The pharmacist documents, to the extent possible, the services provided by the 19
323		-	pharmacist in the patient's record in the patient profile record system maintained by the pharmacy. 20
324		-	The pharmacist shall maintain records of PrEP or PEP drugs dispensed or administered to each 21
325		-	patient; 22
326		-	(vi) The pharmacist does not dispense or administer more than a sixty (60) day supply of a 23
327		-	PrEP or PEP drug to a single patient once every two (2) years, unless otherwise directed by a 24
328		-	practitioner; and 25
329		-	(vii) The pharmacist notifies the patient's primary care provider that the pharmacist 26
330		-	completed the requirements specified in this subsection. If the patient does not have a primary care 27
331		-	provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 28
332		-	provide the patient a list of physicians, clinics or other health care providers to contact regarding 29
333		-	follow-up care. 30
334		-	(3) A pharmacist shall dispense or administer a complete course of a post-exposure 31
335		-	prophylaxis drug as long as all of the following conditions are met: 32
336		-	(i) The pharmacist screens the patient and determines that the exposure occurred within the 33
337		-	previous seventy-two (72) hours and the patient otherwise meets the clinical criteria for a post-34
338		-
339		-
340		-	LC002548/SUB A - Page 10 of 11
341		-	exposure prophylaxis drug under CDC guidelines; 1
342		-	(ii) The pharmacist provides HIV testing to the patient or determines that the patient is 2
343		-	willing to undergo HIV testing consistent with CDC guidelines. If the patient refuses to undergo 3
344		-	HIV testing but is otherwise eligible for a post-exposure prophylaxis drug under this subsection, 4
345		-	the pharmacist may dispense or administer a post-exposure prophylaxis drug; 5
346		-	(iii) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 6
347		-	the use of a post-exposure prophylaxis drug. The pharmacist shall also inform the patient of the 7
348		-	availability of a PrEP or PEP drug for persons who are at substantial risk of acquiring HIV; and 8
349		-	(iv) The pharmacist notifies the patient's primary care provider of the dispensing or 9
350		-	administering of the post-exposure prophylaxis drug. If the patient does not have a primary care 10
351		-	provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 11
352		-	provide the patient a list of physicians, clinics or other health care providers to contact regarding 12
353		-	follow-up care. 13
354		-	(4) The board shall promulgate rules and regulations establishing standards for authorizing 14
355		-	pharmacists to prescribe, dispense and administer HIV prevention drugs in accordance with this 15
356		-	section, including adequate training requirements and protocols for when there is no prescription 16
357		-	drug order, standing order or collaborative practice agreement. 17
358		-	SECTION 5. This act shall take effect upon passage. 18
	251	+	(c) Rules, regulations and protocols. The board shall promulgate rules and regulations 22
	252	+	establishing standards for authorizing pharmacists to prescribe, dispense and administer HIV 23
	253	+	prevention drugs in accordance with subsection (b) of this section, including adequate training 24
	254	+	requirements and protocols for when there is no prescription drug order, standing order or 25
	255	+	collaborative practice agreement. 26
	256	+	SECTION 3. This act shall take effect on January 1, 2024. 27
359	257		========
360		-	LC002548~~/SUB A~~
	258	+	LC002548
361	259		========
362	260
363	261
364		-	LC002548~~/SUB A~~ - Page 11 of 11
	262	+	LC002548 - Page 8 of 8
365	263		EXPLANATION
366	264		BY THE LEGISLATIVE COUNCIL
367	265		OF
368	266		A N A C T
369		-	RELATING TO INSURANCE -- ACCIDENT AND SICKNESS INSURANCE POLICIES
	267	+	RELATING TO INSURANCE -- INSURANCE COVERAGE F OR PREVENTION OF HIV
	268	+	INFECTION
370	269		***
371		-	This act would require health insurance coverage for the treatment of pre-exposure 1
372		-	prophylaxis (PrEP) for the prevention of HIV and post-exposure prophylaxis (PEP) to prevent HIV 2
373		-	infection, commencing January 1, 2024. This act would also direct the board of pharmacy to 3
374		-	promulgate rules and regulations establishing standards for authorizing pharmacists to prescribe, 4
375		-	dispense and administer HIV prevention drugs in accordance with this section, including adequate 5
376		-	training requirements and protocols for when there is no prescription drug order, standing order or 6
377		-	collaborative practice agreement. 7
378		-	This act would take effect upon passage. 8
	270	+	This act would require coverage for the treatment of pre-exposure prophylaxis (PrEP) for 1
	271	+	the prevention of HIV and post-exposure prophylaxis (PEP) for treatment of HIV infection, 2
	272	+	commencing January 1, 2024. 3
	273	+	This act would take effect on January 1, 2024. 4
379	274		========
380		-	LC002548~~/SUB A~~
	275	+	LC002548
381	276		========