2023 -- S 0563 SUBSTITUTE A AS AMENDED ======== LC001940/SUB A/2 ======== S T A T E O F R H O D E I S L A N D IN GENERAL ASSEMBLY JANUARY SESSION, A.D. 2023 ____________ A N A C T RELATING TO INSURANCE -- INSURANCE COVERAGE FOR PREVENTION OF HIV INFECTION Introduced By: Senators Murray, Valverde, Lauria, Pearson, Euer, Lawson, Mack, Acosta, Miller, and Cano Date Introduced: March 07, 2023 Referred To: Senate Health & Human Services It is enacted by the General Assembly as follows: "SECTION 1. Chapter 27-18 of the General Laws entitled "Accident and Sickness 1 Insurance Policies" is hereby amended by adding thereto the following sections: 2 27-18-91. Coverage for treatment of pre-exposure prophylaxis (PrEP) for the 3 prevention of HIV and post-exposure prophylaxis (PEP) to prevent HIV infection. 4 (a) Every group health insurance contract, or every group hospital or medical expense 5 insurance policy, plan, or group policy delivered, issued for delivery, or renewed in this state, by 6 any health insurance carrier, on or after January 1, 2024, shall provide coverage for treatment of 7 pre-exposure prophylaxis (“PrEP”) for the prevention of HIV and post-exposure prophylaxis 8 (“PEP”) to prevent HIV infection. Each long-acting injectable drug with a different duration shall 9 constitute a separate method of administration. A health insurer is not required to cover any 10 preexposure prophylaxis drug or post exposure prophylaxis drug dispensed or administered by an 11 out-of-network pharmacy provider unless the enrollee’s health plan provides an out-of-network 12 pharmacy benefit. 13 (b) The healthcare benefits outlined in this chapter apply only to services delivered within 14 the health insurer’s provider network; provided that, all health insurers shall be required to provide 15 coverage for those benefits mandated by this chapter outside of the health insurer’s provider 16 network where it can be established that the required services are not available from a provider in 17 the health insurer’s network. 18 LC001940/SUB A/2 - Page 2 of 15 27-18-92. Expedited Prior Authorization. 1 To the extent a prior authorization is permitted and applied, then it shall be conducted in 2 an expedited manner as soon as possible, but no later than seventy-two (72) hours pursuant to § 27-3 18.9-6(a)(1). 4 27-18-93. Dispensing and Administration of HIV PrEP or PEP Drugs. 5 (a) Notwithstanding any provision of law to the contrary and as authorized by the Rhode 6 Island board of pharmacy (the “board”) in accordance with rules and regulations adopted under 7 subsection (e) of this section, a pharmacist may prescribe, dispense and administer HIV PrEP or 8 PEP drugs (hereinafter sometimes referred to as “prevention drugs”) as described in § 27-18-91(a) 9 pursuant to a standing order or collaborative practice agreement or to protocols developed by the 10 board for when there is no prescription drug order, standing order or collaborative practice 11 agreement in accordance with the requirements in this subsection and may also order laboratory 12 testing for HIV infection as necessary. 13 (b) Before furnishing an HIV PrEP or PEP drug to a patient, a pharmacist shall complete a 14 training program approved by the board on the use of protocols developed by the board for 15 prescribing, dispensing and administering an HIV prevention drug, on the requirements for any 16 laboratory testing for HIV infection and on guidelines for prescription adherence and best practices 17 to counsel patients prescribed an HIV prevention drug. 18 (c) A pharmacist shall dispense or administer a PrEP or PEP drug in at least a thirty (30) 19 day supply, and up to a sixty (60) day supply, as long as all of the following conditions are met: 20 (1) The patient tests negative for HIV infection, as documented by a negative HIV test 21 result obtained within the previous seven (7) days. If the patient does not provide evidence of a 22 negative HIV test result, the pharmacist shall order an HIV test. If the test results are not transmitted 23 directly to the pharmacist, the pharmacist shall verify the test results to the pharmacist's satisfaction. 24 If the patient tests positive for HIV infection, the pharmacist or person administering the test shall 25 direct the patient to a primary care provider and provide a list of primary care providers and clinics 26 within a reasonable travel distance of the patient's residence; 27 (2) The patient does not report any signs or symptoms of acute HIV infection on a self-28 reporting checklist of acute HIV infection signs and symptoms; 29 (3) The patient does not report taking any contraindicated medications; 30 (4) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 31 the ongoing use of a PrEP or PEP drug. The pharmacist shall notify the patient that the patient shall 32 be seen by a primary care provider to receive subsequent prescriptions for a PrEP or PEP drug and 33 that a pharmacist shall not dispense or administer more than a sixty (60) day supply of a PrEP or 34 LC001940/SUB A/2 - Page 3 of 15 PEP drug to a single patient once every two (2) years without a prescription; 1 (5) The pharmacist documents, to the extent possible, the services provided by the 2 pharmacist in the patient's record in the patient profile record system maintained by the pharmacy. 3 The pharmacist shall maintain records of PrEP or PEP drugs dispensed or administered to each 4 patient; 5 (6) The pharmacist does not dispense or administer more than a sixty (60) day supply of a 6 PrEP or PEP drug to a single patient once every two (2) years, unless otherwise directed by a 7 practitioner; and 8 (7) The pharmacist notifies the patient's primary care provider that the pharmacist 9 completed the requirements specified in this subsection. If the patient does not have a primary care 10 provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 11 provide the patient a list of physicians, clinics or other health care providers to contact regarding 12 follow-up care. 13 (d) A pharmacist shall dispense or administer a complete course of a post-exposure 14 prophylaxis drug as long as all of the following conditions are met: 15 (1) The pharmacist screens the patient and determines that the exposure occurred within 16 the previous seventy-two (72) hours and the patient otherwise meets the clinical criteria for a post 17 exposure prophylaxis drug under CDC guidelines; 18 (2) The pharmacist provides HIV testing to the patient or determines that the patient is 19 willing to undergo HIV testing consistent with CDC guidelines. If the patient refuses to undergo 20 HIV testing but is otherwise eligible for a post-exposure prophylaxis drug under this subsection, 21 the pharmacist may dispense or administer a post-exposure prophylaxis drug; 22 (3) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 23 the use of a post-exposure prophylaxis drug. The pharmacist shall also inform the patient of the 24 availability of a PrEP or PEP drug for persons who are at substantial risk of acquiring HIV; and 25 (4) The pharmacist notifies the patient's primary care provider of the dispensing or 26 administering of the post-exposure prophylaxis drug. If the patient does not have a primary care 27 provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 28 provide the patient a list of physicians, clinics or other health care providers to contact regarding 29 follow-up care. 30 (e) The board shall promulgate rules and regulations establishing standards for authorizing 31 pharmacists to prescribe, dispense and administer HIV prevention drugs in accordance with this 32 section, including adequate training requirements and protocols for when there is no prescription 33 drug order, standing order or collaborative practice agreement. 34 LC001940/SUB A/2 - Page 4 of 15 SECTION 2. Chapter 27-19 of the General Laws entitled "Nonprofit Hospital Service 1 Corporations" is hereby amended by adding thereto the following sections: 2 27-19-83. Coverage for treatment of pre-exposure prophylaxis (PrEP) for the 3 prevention of HIV and post-exposure prophylaxis (PEP) to prevent HIV infection. 4 (a) Every group health insurance contract, or every group hospital or medical expense 5 insurance policy, plan, or group policy delivered, issued for delivery, or renewed in this state, by 6 any health insurance carrier, on or after January 1, 2024, shall provide coverage for treatment of 7 pre-exposure prophylaxis (“PrEP”) for the prevention of HIV and post-exposure prophylaxis 8 (“PEP”) to prevent HIV infection. Each long-acting injectable drug with a different duration shall 9 constitute a separate method of administration. A health insurer is not required to cover any 10 preexposure prophylaxis drug or post exposure prophylaxis drug dispensed or administered by an 11 out-of-network pharmacy provider unless the enrollee’s health plan provides an out-of-network 12 pharmacy benefit. 13 (b) The healthcare benefits outlined in this chapter apply only to services delivered within 14 the health insurer’s provider network; provided that, all health insurers shall be required to provide 15 coverage for those benefits mandated by this chapter outside of the health insurer’s provider 16 network where it can be established that the required services are not available from a provider in 17 the health insurer’s network. 18 27-19-84. Expedited Prior Authorization. 19 To the extent a prior authorization is permitted and applied, then it shall be conducted in 20 an expedited manner as soon as possible, but no later than seventy-two (72) hours pursuant to § 27-21 18.9-6(a)(1). 22 27-19-85. Dispensing and Administration of HIV PrEP or PEP Drugs. 23 (a) Notwithstanding any provision of law to the contrary and as authorized by the Rhode 24 Island board of pharmacy (the “board”) in accordance with rules and regulations adopted under 25 subsection (e) of this section, a pharmacist may prescribe, dispense and administer HIV PrEP or 26 PEP drugs (hereinafter sometimes referred to as “prevention drugs”) as described in § 27-18-91(a) 27 pursuant to a standing order or collaborative practice agreement or to protocols developed by the 28 board for when there is no prescription drug order, standing order or collaborative practice 29 agreement in accordance with the requirements in this subsection and may also order laboratory 30 testing for HIV infection as necessary. 31 (b) Before furnishing an HIV PrEP or PEP drug to a patient, a pharmacist shall complete a 32 training program approved by the board on the use of protocols developed by the board for 33 prescribing, dispensing and administering an HIV prevention drug, on the requirements for any 34 LC001940/SUB A/2 - Page 5 of 15 laboratory testing for HIV infection and on guidelines for prescription adherence and best practices 1 to counsel patients prescribed an HIV prevention drug. 2 (c) A pharmacist shall dispense or administer a PrEP or PEP drug in at least a thirty (30) 3 day supply, and up to a sixty (60) day supply, as long as all of the following conditions are met: 4 (1) The patient tests negative for HIV infection, as documented by a negative HIV test 5 result obtained within the previous seven (7) days. If the patient does not provide evidence of a 6 negative HIV test result, the pharmacist shall order an HIV test. If the test results are not transmitted 7 directly to the pharmacist, the pharmacist shall verify the test results to the pharmacist's satisfaction. 8 If the patient tests positive for HIV infection, the pharmacist or person administering the test shall 9 direct the patient to a primary care provider and provide a list of primary care providers and clinics 10 within a reasonable travel distance of the patient's residence; 11 (2) The patient does not report any signs or symptoms of acute HIV infection on a self-12 reporting checklist of acute HIV infection signs and symptoms; 13 (3) The patient does not report taking any contraindicated medications; 14 (4) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 15 the ongoing use of a PrEP or PEP drug. The pharmacist shall notify the patient that the patient shall 16 be seen by a primary care provider to receive subsequent prescriptions for a PrEP or PEP drug and 17 that a pharmacist shall not dispense or administer more than a sixty (60) day supply of a PrEP or 18 PEP drug to a single patient once every two (2) years without a prescription; 19 (5) The pharmacist documents, to the extent possible, the services provided by the 20 pharmacist in the patient's record in the patient profile record system maintained by the pharmacy. 21 The pharmacist shall maintain records of PrEP or PEP drugs dispensed or administered to each 22 patient; 23 (6) The pharmacist does not dispense or administer more than a sixty (60) day supply of a 24 PrEP or PEP drug to a single patient once every two (2) years, unless otherwise directed by a 25 practitioner; and 26 (7) The pharmacist notifies the patient's primary care provider that the pharmacist 27 completed the requirements specified in this subsection. If the patient does not have a primary care 28 provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 29 provide the patient a list of physicians, clinics or other health care providers to contact regarding 30 follow-up care. 31 (d) A pharmacist shall dispense or administer a complete course of a post-exposure 32 prophylaxis drug as long as all of the following conditions are met: 33 (1) The pharmacist screens the patient and determines that the exposure occurred within 34 LC001940/SUB A/2 - Page 6 of 15 the previous seventy-two (72) hours and the patient otherwise meets the clinical criteria for a post 1 exposure prophylaxis drug under CDC guidelines; 2 (2) The pharmacist provides HIV testing to the patient or determines that the patient is 3 willing to undergo HIV testing consistent with CDC guidelines. If the patient refuses to undergo 4 HIV testing but is otherwise eligible for a post-exposure prophylaxis drug under this subsection, 5 the pharmacist may dispense or administer a post-exposure prophylaxis drug; 6 (3) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 7 the use of a post-exposure prophylaxis drug. The pharmacist shall also inform the patient of the 8 availability of a PrEP or PEP drug for persons who are at substantial risk of acquiring HIV; and 9 (4) The pharmacist notifies the patient's primary care provider of the dispensing or 10 administering of the post-exposure prophylaxis drug. If the patient does not have a primary care 11 provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 12 provide the patient a list of physicians, clinics or other health care providers to contact regarding 13 follow-up care. 14 (e) The board shall promulgate rules and regulations establishing standards for authorizing 15 pharmacists to prescribe, dispense and administer HIV prevention drugs in accordance with this 16 section, including adequate training requirements and protocols for when there is no prescription 17 drug order, standing order or collaborative practice agreement. 18 SECTION 3. Chapter 27-20 of the General Laws entitled "Nonprofit Medical Service 19 Corporations" is hereby amended by adding thereto the following sections: 20 27-20-79. Coverage for treatment of pre-exposure prophylaxis (PrEP) for the 21 prevention of HIV and post-exposure prophylaxis (PEP) to prevent HIV infection. 22 (a) Every group health insurance contract, or every group hospital or medical expense 23 insurance policy, plan, or group policy delivered, issued for delivery, or renewed in this state, by 24 any health insurance carrier, on or after January 1, 2024, shall provide coverage for treatment of 25 pre-exposure prophylaxis (“PrEP”) for the prevention of HIV and post-exposure prophylaxis 26 (“PEP”) to prevent HIV infection. Each long-acting injectable drug with a different duration shall 27 constitute a separate method of administration. A health insurer is not required to cover any 28 preexposure prophylaxis drug or post exposure prophylaxis drug dispensed or administered by an 29 out-of-network pharmacy provider unless the enrollee’s health plan provides an out-of-network 30 pharmacy benefit. 31 (b) The healthcare benefits outlined in this chapter apply only to services delivered within 32 the health insurer’s provider network; provided that, all health insurers shall be required to provide 33 coverage for those benefits mandated by this chapter outside of the health insurer’s provider 34 LC001940/SUB A/2 - Page 7 of 15 network where it can be established that the required services are not available from a provider in 1 the health insurer’s network. 2 27-20-80. Expedited Prior Authorization. 3 To the extent a prior authorization is permitted and applied, then it shall be conducted in 4 an expedited manner as soon as possible, but no later than seventy-two (72) hours pursuant § 27-5 18.9-6(a)(1). 6 27-20-81. Dispensing and Administration of HIV PrEP or PEP Drugs. 7 (a) Notwithstanding any provision of law to the contrary and as authorized by the Rhode 8 Island board of pharmacy (the “board”) in accordance with rules and regulations adopted under 9 subsection (e) of this section, a pharmacist may prescribe, dispense and administer HIV PrEP or 10 PEP drugs (hereinafter sometimes referred to as “prevention drugs”) as described in § 27-18-91(a) 11 of this section pursuant to a standing order or collaborative practice agreement or to protocols 12 developed by the board for when there is no prescription drug order, standing order or collaborative 13 practice agreement in accordance with the requirements in this subsection and may also order 14 laboratory testing for HIV infection as necessary. 15 (b) Before furnishing an HIV PrEP or PEP drug to a patient, a pharmacist shall complete a 16 training program approved by the board on the use of protocols developed by the board for 17 prescribing, dispensing and administering an HIV prevention drug, on the requirements for any 18 laboratory testing for HIV infection and on guidelines for prescription adherence and best practices 19 to counsel patients prescribed an HIV prevention drug. 20 (c) A pharmacist shall dispense or administer a PrEP or PEP drug in at least a thirty (30) 21 day supply, and up to a sixty (60) day supply, as long as all of the following conditions are met: 22 (1) The patient tests negative for HIV infection, as documented by a negative HIV test 23 result obtained within the previous seven (7) days. If the patient does not provide evidence of a 24 negative HIV test result, the pharmacist shall order an HIV test. If the test results are not transmitted 25 directly to the pharmacist, the pharmacist shall verify the test results to the pharmacist's satisfaction. 26 If the patient tests positive for HIV infection, the pharmacist or person administering the test shall 27 direct the patient to a primary care provider and provide a list of primary care providers and clinics 28 within a reasonable travel distance of the patient's residence; 29 (2) The patient does not report any signs or symptoms of acute HIV infection on a self-30 reporting checklist of acute HIV infection signs and symptoms; 31 (3) The patient does not report taking any contraindicated medications; 32 (4) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 33 the ongoing use of a PrEP or PEP drug. The pharmacist shall notify the patient that the patient shall 34 LC001940/SUB A/2 - Page 8 of 15 be seen by a primary care provider to receive subsequent prescriptions for a PrEP or PEP drug and 1 that a pharmacist shall not dispense or administer more than a sixty (60) day supply of a PrEP or 2 PEP drug to a single patient once every two (2) years without a prescription; 3 (5) The pharmacist documents, to the extent possible, the services provided by the 4 pharmacist in the patient's record in the patient profile record system maintained by the pharmacy. 5 The pharmacist shall maintain records of PrEP or PEP drugs dispensed or administered to each 6 patient; 7 (6) The pharmacist does not dispense or administer more than a sixty (60) day supply of a 8 PrEP or PEP drug to a single patient once every two (2) years, unless otherwise directed by a 9 practitioner; and 10 (7) The pharmacist notifies the patient's primary care provider that the pharmacist 11 completed the requirements specified in this subsection. If the patient does not have a primary care 12 provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 13 provide the patient a list of physicians, clinics or other health care providers to contact regarding 14 follow-up care. 15 (d) A pharmacist shall dispense or administer a complete course of a post-exposure 16 prophylaxis drug as long as all of the following conditions are met: 17 (1) The pharmacist screens the patient and determines that the exposure occurred within 18 the previous seventy-two (72) hours and the patient otherwise meets the clinical criteria for a post 19 exposure prophylaxis drug under CDC guidelines; 20 (2) The pharmacist provides HIV testing to the patient or determines that the patient is 21 willing to undergo HIV testing consistent with CDC guidelines. If the patient refuses to undergo 22 HIV testing but is otherwise eligible for a post-exposure prophylaxis drug under this subsection, 23 the pharmacist may dispense or administer a post-exposure prophylaxis drug; 24 (3) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 25 the use of a post-exposure prophylaxis drug. The pharmacist shall also inform the patient of the 26 availability of a PrEP or PEP drug for persons who are at substantial risk of acquiring HIV; and 27 (4) The pharmacist notifies the patient's primary care provider of the dispensing or 28 administering of the post-exposure prophylaxis drug. If the patient does not have a primary care 29 provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 30 provide the patient a list of physicians, clinics or other health care providers to contact regarding 31 follow-up care. 32 (e) The board shall promulgate rules and regulations establishing standards for authorizing 33 pharmacists to prescribe, dispense and administer HIV prevention drugs in accordance with this 34 LC001940/SUB A/2 - Page 9 of 15 section, including adequate training requirements and protocols for when there is no prescription 1 drug order, standing order to collaborative practice agreement. 2 SECTION 4. Chapter 27-41 of the General Laws entitled "Health Maintenance 3 Organizations" is hereby amended by adding thereto the following sections: 4 27-41-96. Coverage for treatment of pre-exposure prophylaxis (PrEP) for the 5 prevention of HIV and post-exposure prophylaxis (PEP) to prevent HIV infection. 6 (a) Every group health insurance contract, or every group hospital or medical expense 7 insurance policy, plan, or group policy delivered, issued for delivery, or renewed in this state, by 8 any health insurance carrier, on or after January 1, 2024, shall provide coverage for treatment of 9 pre-exposure prophylaxis (“PrEP”) for the prevention of HIV and post-exposure prophylaxis 10 (“PEP”) to prevent HIV infection. Each long-acting injectable drug with a different duration shall 11 constitute a separate method of administration. A health insurer is not required to cover any 12 preexposure prophylaxis drug or post exposure prophylaxis drug dispensed or administered by an 13 out-of-network pharmacy provider unless the enrollee’s health plan provides an out-of-network 14 pharmacy benefit. 15 (b) The healthcare benefits outlined in this chapter apply only to services delivered within 16 the health insurer’s provider network; provided that, all health insurers shall be required to provide 17 coverage for those benefits mandated by this chapter outside of the health insurer’s provider 18 network where it can be established that the required services are not available from a provider in 19 the health insurer’s network. 20 27-41-97. Expedited Prior Authorization. 21 To the extent a prior authorization is permitted and applied, then it shall be conducted in 22 an expedited manner as soon as possible, but no later than seventy-two (72) hours pursuant to § 27-23 18.9-6(a)(1). 24 27-41-98. Dispensing and Administration of HIV PrEP or PEP Drugs. 25 (a) Notwithstanding any provision of law to the contrary and as authorized by the Rhode 26 Island board of pharmacy (the “board”) in accordance with rules and regulations adopted under 27 subsection (e) of this section, a pharmacist may prescribe, dispense and administer HIV PrEP or 28 PEP drugs (hereinafter sometimes referred to as “prevention drugs”) as described in § 27-18-91(a) 29 pursuant to a standing order or collaborative practice agreement or to protocols developed by the 30 board for when there is no prescription drug order, standing order or collaborative practice 31 agreement in accordance with the requirements in this subsection and may also order laboratory 32 testing for HIV infection as necessary. 33 (b) Before furnishing an HIV PrEP or PEP drug to a patient, a pharmacist shall complete a 34 LC001940/SUB A/2 - Page 10 of 15 training program approved by the board on the use of protocols developed by the board for 1 prescribing, dispensing and administering an HIV prevention drug, on the requirements for any 2 laboratory testing for HIV infection and on guidelines for prescription adherence and best practices 3 to counsel patients prescribed an HIV prevention drug. 4 (c) A pharmacist shall dispense or administer a PrEP or PEP drug in at least a thirty (30) 5 day supply, and up to a sixty (60) day supply, as long as all of the following conditions are met: 6 (1) The patient tests negative for HIV infection, as documented by a negative HIV test 7 result obtained within the previous seven (7) days. If the patient does not provide evidence of a 8 negative HIV test result, the pharmacist shall order an HIV test. If the test results are not transmitted 9 directly to the pharmacist, the pharmacist shall verify the test results to the pharmacist's satisfaction. 10 If the patient tests positive for HIV infection, the pharmacist or person administering the test shall 11 direct the patient to a primary care provider and provide a list of primary care providers and clinics 12 within a reasonable travel distance of the patient's residence; 13 (2) The patient does not report any signs or symptoms of acute HIV infection on a self-14 reporting checklist of acute HIV infection signs and symptoms; 15 (3) The patient does not report taking any contraindicated medications; 16 (4) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 17 the ongoing use of a PrEP or PEP drug. The pharmacist shall notify the patient that the patient shall 18 be seen by a primary care provider to receive subsequent prescriptions for a PrEP or PEP drug and 19 that a pharmacist shall not dispense or administer more than a sixty (60) day supply of a PrEP or 20 PEP drug to a single patient once every two (2) years without a prescription; 21 (5) The pharmacist documents, to the extent possible, the services provided by the 22 pharmacist in the patient's record in the patient profile record system maintained by the pharmacy. 23 The pharmacist shall maintain records of PrEP or PEP drugs dispensed or administered to each 24 patient; 25 (6) The pharmacist does not dispense or administer more than a sixty (60) day supply of a 26 PrEP or PEP drug to a single patient once every two (2) years, unless otherwise directed by a 27 practitioner; and 28 (7) The pharmacist notifies the patient's primary care provider that the pharmacist 29 completed the requirements specified in this subsection. If the patient does not have a primary care 30 provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 31 provide the patient a list of physicians, clinics or other health care providers to contact regarding 32 follow-up care. 33 (d) A pharmacist shall dispense or administer a complete course of a post-exposure 34 LC001940/SUB A/2 - Page 11 of 15 prophylaxis drug as long as all of the following conditions are met: 1 (1) The pharmacist screens the patient and determines that the exposure occurred within 2 the previous seventy-two (72) hours and the patient otherwise meets the clinical criteria for a post 3 exposure prophylaxis drug under CDC guidelines; 4 (2) The pharmacist provides HIV testing to the patient or determines that the patient is 5 willing to undergo HIV testing consistent with CDC guidelines. If the patient refuses to undergo 6 HIV testing but is otherwise eligible for a post-exposure prophylaxis drug under this subsection, 7 the pharmacist may dispense or administer a post-exposure prophylaxis drug; 8 (3) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on 9 the use of a post-exposure prophylaxis drug. The pharmacist shall also inform the patient of the 10 availability of a PrEP or PEP drug for persons who are at substantial risk of acquiring HIV; and 11 (4) The pharmacist notifies the patient's primary care provider of the dispensing or 12 administering of the post-exposure prophylaxis drug. If the patient does not have a primary care 13 provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall 14 provide the patient a list of physicians, clinics or other health care providers to contact regarding 15 follow-up care. 16 (e) The board shall promulgate rules and regulations establishing standards for authorizing 17 pharmacists to prescribe, dispense and administer HIV prevention drugs in accordance with this 18 section, including adequate training requirements and protocols for when there is no prescription 19 drug order, standing order or collaborative practice agreement. 20 SECTION 5. Section 23-6.3-2 of the General Laws in Chapter 23-6.3 entitled "Prevention 21 and Suppression of Contagious Diseases - HIV/AIDS" is hereby amended to read as follows: 22 23-6.3-2. Definitions. 23 As used in this chapter the following words shall have the following meanings: 24 (1) "Agent" means a person empowered by the patient to assert or waive the confidentiality, 25 or to disclose or consent to the disclosure of confidential information, as established by chapter 26 37.3 of title 5, as amended, entitled "Confidentiality of Health Care Communications and 27 Information Act." 28 (2) "AIDS" means the medical condition known as acquired immune deficiency syndrome, 29 caused by infection of an individual by the human immunodeficiency virus (HIV). 30 (3) "Anonymous HIV testing" means an HIV test that utilizes a laboratory generated code 31 based system, which does not require an individual's name or other identifying information that 32 may reveal one's identity, including information related to the individual's health insurance policy, 33 to be associated with the test. 34 LC001940/SUB A/2 - Page 12 of 15 (4) "Antibody" means a protein produced by the body in response to specific foreign 1 substances such as bacteria or viruses. 2 (5) "Community-based organization" means an entity that has written authorization from 3 the department for HIV counseling, testing and referral services (HIV CTRS). 4 (6) "Confidential HIV testing" means an HIV test that requires the individual's name and 5 other identifying information including information related to the individual's health insurance 6 policy, as appropriate. 7 (7) "Consent" means an explicit exchange of information between a person and a healthcare 8 provider or qualified professional HIV test counselor through which an informed individual can 9 choose whether to undergo HIV testing or decline to do so. Elements of consent shall include 10 providing each individual with verbal or written information regarding an explanation of HIV 11 infection, a description of interventions that can reduce HIV transmission, the meanings of positive 12 and negative test results, the voluntary nature of the HIV testing, an opportunity to ask questions 13 and to decline testing. 14 (8) "Controlled substance" means a drug, substance, or immediate precursor in schedules 15 I-V listed in the provisions of chapter 28 of title 21 entitled, "Uniform Controlled Substances Act." 16 (9) "Department" means the Rhode Island department of health. 17 (10) "Diagnosis of AIDS" means the most current surveillance case definition for AIDS 18 published in the Centers for Disease Control & Prevention (CDC). 19 (11) "Diagnosis of HIV" means the most current surveillance case definition for HIV 20 infection published in the CDC's (MMWR). 21 (12) "Director" means the director of the Rhode Island department of health. 22 (13) "ELISA result" means enzyme-linked immunosorbent assay or EIA (enzyme 23 immunoassay) which is a serologic technique used in immunology to detect the presence of either 24 antibody or antigen. 25 (14) "Health benefits" include accident and sickness, including disability or health 26 insurance, health benefit plans and/or policies, hospital, health, or medical service plans, or any 27 health maintenance organization plan pursuant to title 27 or otherwise. 28 (15) "Healthcare facility" means those facilities licensed by the department in accordance 29 with the provisions of chapter 17 of this title. 30 (16) "Healthcare provider," as used herein, means a licensed physician, physician assistant, 31 certified nurse practitioner, pharmacist or midwife. 32 (17) "Healthcare settings" means venues offering clinical STD services including, but not 33 limited to, hospitals, urgent care clinics, STD clinics and other substance abuse treatment facilities, 34 LC001940/SUB A/2 - Page 13 of 15 mental health treatment facilities, community health centers, primary care and OB/GYN physician 1 offices, and family planning providers. 2 (18) "HIV" means the human immunodeficiency virus, the pathogenic organism 3 responsible for HIV infection and/or the acquired immunodeficiency syndrome (AIDS) in humans. 4 (19) "HIV CD4 T-lymphocyte test result" means the results of any currently medically 5 accepted and/or FDA approved test used to count CD4 T-lymphatic cells in the blood of an HIV-6 infected person. 7 (20) "HIV counseling" means an interactive process of communication between a person 8 and a healthcare provider or qualified professional HIV test counselor during which there is an 9 assessment of the person's risks for HIV infection and the provision of counseling to assist the 10 person with behavior changes that can reduce risks for acquiring HIV infection. 11 (21) "HIV screening" means the conduct of HIV testing among those who do not show 12 signs or symptoms of an HIV infection. 13 (22) "HIV test" means any currently medically accepted and/or FDA approved test for 14 determining HIV infection in humans. 15 (23) "Occupational health representative" means a person, within a healthcare facility, 16 trained to respond to occupational, particularly blood borne, exposures. 17 (24) "Opts out" means that a person who has been notified that a voluntary HIV test will 18 be performed, has elected to decline or defer testing. Consent to HIV testing is inferred unless the 19 individual declines testing. 20 (25) "Perinatal case report for HIV" means the information that is provided to the 21 department related to a child aged less than eighteen (18) months born to an HIV-infected mother 22 and the child does not meet the criteria for HIV infection or the criteria for "not infected" with HIV 23 as defined in the most current surveillance case definition for HIV infection published by the CDC. 24 (26) "Person" means any individual, trust or estate, partnership, corporation (including 25 associations, joint stock companies), limited liability companies, state, or political subdivision or 26 instrumentality of a state. 27 (27) "Persons at high risk for HIV infection" means persons defined as being high risk in 28 the CDC's most current recommendations for HIV testing of adults, adolescents and pregnant 29 women in healthcare settings or through authority and responsibilities conferred on the director by 30 law in protecting the public's health. 31 (28) "Polymerase chain reaction (PCR) test" means a common laboratory method of 32 creating copies of specific fragments of DNA or RNA. 33 (29) "Qualified professional HIV test counselor" means: (i) A physician, physician 34 LC001940/SUB A/2 - Page 14 of 15 assistant, certified nurse practitioner, midwife, or nurse licensed to practice in accordance with 1 applicable state law; (ii) A medical student who is actively matriculating in a medical degree 2 program and who performs duties assigned to them by a physician; or (iii) A person who has 3 completed an HIV counseling training program, in accordance with regulations hereunder 4 promulgated. 5 (30) "Sexually transmitted diseases (STD's)" means those diseases included in § 23-11-1, 6 as amended, entitled "Sexually Transmitted Diseases," and any other sexually transmitted disease 7 that may be required to be reported by the department. 8 SECTION 6. This act shall take effect on January 1, 2024. 9 ======== LC001940/SUB A/2 ======== LC001940/SUB A/2 - Page 15 of 15 EXPLANATION BY THE LEGISLATIVE COUNCIL OF A N A C T RELATING TO INSURANCE -- INSURANCE COVERAGE FOR PREVENT ION OF HIV INFECTION *** This act would require coverage for the treatment of pre-exposure prophylaxis (PrEP) for 1 the prevention of HIV and post-exposure prophylaxis (PEP) for treatment of HIV infection, 2 commencing January 1, 2024. 3 This act would take effect on January 1, 2024. 4 ======== LC001940/SUB A/2 ========