S1039 1R

An Act concerning pharmacists and supplementing P.L.2003, c.280 (C.45:14-40 et seq.), P.L.1997, c.192 (C.26:2S-1 et seq.), and P.L.1968, c.413 (C.30:4D-1 et seq.).

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. As used in this act:

“CDC PEP guidelines” means the “Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV – United States, 2016,” or any subsequent guidelines, published by the federal Centers for Disease Control and Prevention.

“CDC PReP guidelines” means the “2017 Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2017 Update: A Clinical Practice Guideline,” or any subsequent guidelines, published by the federal Centers for Disease Control and Prevention.

“HIV” means the human immunodeficiency virus.

“HIV preexposure prophylaxis” means a fixed-dose combination of tenofovir disoproxil fumarate (TDF) (300 mg) with emtricitabine (FTC) (200 mg), or another drug or drug combination determined by the State Board of Pharmacy to meet the same clinical eligibility recommendations provided in the CEC PReP guidelines.

“HIV postexposure prophylaxis” means: tenofovir disoproxil fumarate (TDF) (300 mg) with emtricitabine (FTC) (200 mg), taken once daily, in combination with either raltegravir (400mg), taken twice daily, or dolutegravir (50mg), taken once daily; tenofovir disoproxil fumarate (TDF) (300 mg) with emtricitabine (FTC) (200 mg), taken once daily, in combination with darunavir (800mg) and ritonavir (100mg), taken once daily; or another drug or drug combination determined by the State Board of Pharmacy to meet the same clinical eligibility recommendations provided in the CEC PRP guidelines.

2. a. Notwithstanding any other provision of law to the contrary, a pharmacist may initiate and furnish HIV preexposure prophylaxis or HIV postexposure prophylaxis to a patient without an individual prescription pursuant to a standing order issued to the pharmacist by the Commissioner of Health or, if the commissioner is not a duly licensed physician, the Deputy Commissioner for Public Health Services. A standing order shall be issued to a pharmacist upon request, provided that the pharmacist satisfies the training requirements set forth in subsection b. of this section and
certifies that the pharmacist will adhere to the requirements set forth in subsection c. of this section concerning the protocols for initiating and furnishing HIV preexposure prophylaxis and the requirements set forth in subsection d. of this section concerning the protocols for initiating and furnishing HIV postexposure prophylaxis to patients without an individual prescription. In no case shall a patient be authorized to waive the consultation required pursuant to subsection c. or subsection d. of this section.

b. A pharmacist shall not be authorized to furnish HIV preexposure prophylaxis or HIV postexposure prophylaxis to a patient without an individual prescription unless the pharmacist completes a training program, approved by the State Board of Pharmacy in consultation with the Department of Health, concerning the use of HIV preexposure prophylaxis and HIV postexposure prophylaxis. At a minimum, the training program shall include information about financial assistance programs available to patients to assist with the costs of HIV preexposure prophylaxis and HIV postexposure prophylaxis.

c. A pharmacist shall furnish at least a 30-day supply, and up to a 60-day supply, of HIV preexposure prophylaxis to a patient without an individual prescription if the following requirements are met:

(1) The patient is HIV-negative, as documented by a negative HIV test result obtained within the previous seven days from an HIV antigen/antibody test or antibody-only test or from a rapid, point-of-care fingerstick blood test approved by the federal Food and Drug Administration. If the patient does not provide evidence of a negative HIV test in accordance with this paragraph, the pharmacist shall order an HIV test. If the test results are not ordered directly to a pharmacist, the pharmacist shall verify the test results to the pharmacist’s satisfaction. If the patient tests positive for HIV infection, the pharmacist or person administering the test shall direct the patient to a primary care provider, provide the patient with information and resources concerning treatment providers and HIV treatment clinics in the region, and ¹[shall]¹ take all other actions required under State and federal law in response to a positive test for HIV;

(2) The patient does not report any signs or symptoms of acute HIV infection on a self-reported checklist of acute HIV infection signs and symptoms;

(3) The patient does not report taking any contraindicated medications, and the pharmacist reviews the patient’s prescription monitoring information to confirm no contraindicated prescriptions have been issued or dispensed to the patient in the past six months;

(4) The patient has not been furnished with HIV preexposure prophylaxis without an individual prescription within the past two years;

(5) The pharmacist provides counseling to the patient on the ongoing use of HIV preexposure prophylaxis, which may include education about side effects, safety during pregnancy and breastfeeding, adherence to recommended dosing, and the importance of timely testing and treatment, as applicable, for HIV, renal function, hepatitis B, hepatitis C, sexually transmitted diseases, and pregnancy for individuals of child-bearing capacity. The pharmacist shall notify the patient that the patient will not be eligible to continue receiving HIV preexposure prophylaxis unless the patient is seen by a primary care provider and issued a prescription for the HIV preexposure prophylaxis, and that the patient may be furnished with no more than a 60-day supply of HIV preexposure prophylaxis by a pharmacist without an individual prescription within any given two year period;

(6) The pharmacist documents, to the extent possible, the services provided by the pharmacist in the patient’s record in the record system maintained by the pharmacy, and includes the dispensation of the HIV preexposure prophylaxis in the prescription monitoring database established pursuant to P.L.2007, c.244 (C.45:1-45 et al.) with a note indicating the HIV preexposure prophylaxis was provided without an individual prescription pursuant to this section; and

(7) The pharmacist notifies the patient’s primary care provider that the pharmacist furnished the patient with HIV preexposure prophylaxis pursuant to this section. If the patient does not have a primary care provider, or refuses to consent to the pharmacist providing notice to the primary care provider pursuant to this paragraph, the pharmacist shall provide the patient with a list of physicians and surgeons, clinics, or other health care service providers to contact regarding ongoing care for HIV preexposure prophylaxis. The Department of Health shall publish and maintain a current list of providers for pharmacists to use for the purposes of this paragraph, which list may be made available on the department’s Internet website.

d. A pharmacist shall furnish a complete course of HIV postexposure prophylaxis to a patient without an individual prescription if the following requirements are met:

(1) The pharmacist ¹[screens the patient and determines the exposure to HIV occurred] confirms with the patient that the exposure to HIV occurred¹ within the previous 72 hours and the patient otherwise meets the clinical criteria for HIV postexposure prophylaxis consistent with the CDC PEP guidelines;

(2) The pharmacist provides HIV testing that is classified as waived under the federal ¹“¹ Clinical Laboratory Improvement Amendments of 1988, ¹”¹ 42 U.S.C. s.263a, or determines the patient is willing to undergo HIV testing consistent with the CDC PEP guidelines;

(3) The pharmacist provides counseling to the patient on the use of HIV postexposure prophylaxis consistent with the CDC PEP guidelines, which may include education about side effects, safety during pregnancy and breastfeeding, adherence to recommended dosing, and the importance of timely testing and treatment, as applicable, for HIV and sexually transmitted diseases. The pharmacist shall additionally inform the patient of the availability of HIV preexposure prophylaxis for persons who are at substantial risk of acquiring HIV; and

(4) The pharmacist notifies the patient’s primary care provider that the pharmacist provided the patient with a complete course of HIV postexposure prophylaxis. If the patient does not have a primary care provider, or refuses to consent to the pharmacist providing notice to the primary care provider pursuant to this paragraph, the pharmacist shall provide the patient with a list of physicians and surgeons, clinics, or other health care service providers to contact regarding followup care for HIV postexposure prophylaxis. The Department of Health shall publish and maintain a current list of providers for pharmacists to use for the purposes of this paragraph, which list may be made available on the department’s Internet website.

¹[3. a. Within 90 days after the date of enactment of this act, and notwithstanding the provisions of the “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et seq.) to the contrary, the State Board of Pharmacy, in consultation with the Department of Health, immediately upon filing proper notice with the Office of Administrative Law, shall adopt rules and regulations as may be necessary to implement the provisions of this act.

b. The rules and regulations adopted pursuant to subsection a. of this section shall be in effect for a period not to exceed one year from the date of filing. These rules and regulations shall thereafter be adopted, amended, or readopted by the board, in consultation with the Department of Health, in accordance with the requirements of the “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et seq.).]¹

¹[4. a. (1) Except as provided in paragraph (2) of this subsection, a health benefits plan that provides prescription benefits shall cover HIV preexposure prophylaxis and HIV postexposure prophylaxis furnished without an individual prescription pursuant to the requirements of section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill) without requiring prior authorization or step therapy.

(2) If the federal Food and Drug Administration has approved one or more therapeutic equivalents of a drug, device, or product for the prevention of HIV and AIDS, paragraph (1) of this subsection shall not be construed to require a health benefits plan to cover all therapeutically equivalent versions without prior authorization or step therapy, if at least one version is covered without prior authorization or step therapy.

b A health benefits plan shall not prohibit, or permit a delegated pharmacy benefits manager to prohibit, a pharmacist from dispensing HIV preexposure prophylaxis or HIV postexposure prophylaxis.

c. A health benefits plan shall not be required to cover HIV preexposure prophylaxis that has been furnished by a pharmacist without an individual prescription pursuant to pursuant to section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill) in excess of a 60-day supply for a single patient within a given two year period.

d. Nothing in this section shall be construed to require a health benefits plan to provide coverage for HIV preexposure prophylaxis or HIV postexposure prophylaxis furnished by a pharmacist at an out-of-network pharmacy, unless the health benefits plan has an out-of-network pharmacy benefit.

e. As used in this section:

“HIV preexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

“HIV postexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

“Step therapy” means requiring that a lower-cost alternative to HIV preexposure prophylaxis or HIV postexposure prophylaxis be shown to have been ineffective as a condition of providing prescription benefits coverage for the prophylaxis.]¹

¹[5. a. (1) Notwithstanding any State law or regulation to the contrary, and except as provided in paragraph (2) of this subsection, the Department of Human Services shall ensure that the provision of benefits for HIV preexposure prophylaxis and HIV postexposure prophylaxis furnished without an individual prescription pursuant to the requirements of section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill) to eligible persons under the Medicaid program, established pursuant to P.L.1968, c.413 (C.30:4D-1 et seq.), shall be provided without the imposition of any prior authorization or step therapy requirements.

(2) If the federal Food and Drug Administration has approved one or more therapeutic equivalents of a drug, device, or product for the prevention of HIV and AIDS, paragraph (1) of this subsection shall not be construed to require the department to ensure coverage of all therapeutically equivalent versions without prior authorization or step therapy, if at least one version is covered without prior authorization or step therapy.

b. As used in this section:

“HIV preexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

“HIV postexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

¹[6. The Commissioner of Human Services shall apply for such State plan amendments or waivers as may be necessary to implement the provisions of section 5 of this act and to secure federal financial participation for State Medicaid expenditures under the federal Medicaid program.]¹

¹[7. a. (1) Except as provided in paragraph (2) of this subsection, the State Health Benefits Commission shall ensure that every contract purchased by the commission on or after the effective date of this act that provides hospital or medical expense benefits that include prescription benefits shall cover HIV preexposure prophylaxis and HIV postexposure prophylaxis furnished without an individual prescription pursuant to the requirements of section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill) without requiring prior authorization or step therapy.

(2) If the federal Food and Drug Administration has approved one or more therapeutic equivalents of a drug, device, or product for the prevention of HIV and AIDS, paragraph (1) of this subsection shall not be construed to require the contract purchased by the commission to cover all therapeutically equivalent versions without prior authorization or step therapy, if at least one version is covered without prior authorization or step therapy.

b The contract purchased by the commission shall not prohibit, or permit a delegated pharmacy benefits manager prohibit, a pharmacist from dispensing HIV preexposure prophylaxis or HIV postexposure prophylaxis.

c. The contract purchased by the commission shall not be required to cover HIV preexposure prophylaxis that has been furnished by a pharmacist without an individual prescription pursuant to pursuant to section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill) in excess of a 60-day supply for a single patient within a given two year period.

d. Nothing in this section shall be construed to require a contract purchased by the commission to provide coverage for HIV preexposure prophylaxis or HIV postexposure prophylaxis furnished by a pharmacist at an out-of-network pharmacy, unless the contract has an out-of-network pharmacy benefit.

e. As used in this section:

“HIV preexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

“HIV postexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

¹[8. a. (1) Except as provided in paragraph (2) of this subsection, the School Employees’ Health Benefits Commission shall ensure that every contract purchased by the commission on or after the effective date of this act that provides hospital or medical expense benefits that include prescription benefits shall cover HIV preexposure prophylaxis and HIV postexposure prophylaxis furnished without an individual prescription pursuant to the requirements of section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill) without requiring prior authorization or step therapy.

(2) If the federal Food and Drug Administration has approved one or more therapeutic equivalents of a drug, device, or product for the prevention of HIV and AIDS, paragraph (1) of this subsection shall not be construed to require the contract purchased by the commission to cover all therapeutically equivalent versions without prior authorization or step therapy, if at least one version is covered without prior authorization or step therapy.

e. As used in this section:

“HIV preexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

“HIV postexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

¹3. a. (1) Except as provided in paragraph (2) of this subsection, no group or individual hospital service corporation contract providing hospital or medical expense benefits shall be delivered, issued, executed, or renewed in this State or approved for issuance or renewal in this State by the Commissioner of Banking and Insurance, on or after the effective date of this act, unless the contract provides benefits to any subscriber or other person covered thereunder for HIV preexposure prophylaxis and HIV postexposure prophylaxis furnished without an individual prescription pursuant to the requirements of section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill) without requiring prior authorization or step therapy.

(2) If the federal Food and Drug Administration has approved one or more therapeutic equivalents of a drug, device, or product for the prevention of HIV and AIDS, paragraph (1) of this subsection shall not be construed to require the contract to cover all therapeutically equivalent versions without prior authorization or step therapy, if at least one version is covered without prior authorization or step therapy.

b. A contract offered by a group or individual hospital service corporation shall not:

(1) prohibit, or permit a delegated pharmacy benefits manager to prohibit, a pharmacist from dispensing HIV preexposure prophylaxis or HIV postexposure prophylaxis; and

(2) be required to cover HIV preexposure prophylaxis that has been furnished by a pharmacist without an individual prescription pursuant to pursuant to section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill) in excess of a 60-day supply for a single patient within a given two year period.

c. Nothing in this section shall be construed to require a contract offered by a group or individual hospital service corporation to provide coverage for HIV preexposure prophylaxis or HIV postexposure prophylaxis furnished by a pharmacist at an out-of-network pharmacy, unless the contract has an out-of-network pharmacy benefit.

d. The provisions of this section shall apply to all contracts in which the hospital service corporation has reserved the right to change the premium.

e. As used in this section:

“HIV preexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

“HIV postexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

¹4. a. (1) Except as provided in paragraph (2) of this subsection, no group or individual medical service corporation contract providing hospital or medical expense benefits shall be delivered, issued, executed, or renewed in this State or approved for issuance or renewal in this State by the Commissioner of Banking and Insurance, on or after the effective date of this act, unless the contract provides benefits to any subscriber or other person covered thereunder for HIV preexposure prophylaxis and HIV postexposure prophylaxis furnished without an individual prescription pursuant to the requirements of section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill) without requiring prior authorization or step therapy.

(2) If the federal Food and Drug Administration has approved one or more therapeutic equivalents of a drug, device, or product for the prevention of HIV and AIDS, paragraph (1) of this subsection shall not be construed to require the contract to cover all therapeutically equivalent versions without prior authorization or step therapy, if at least one version is covered without prior authorization or step therapy.

b. A contract offered by a group or individual medical service corporation shall not:

(1) prohibit, or permit a delegated pharmacy benefits manager to prohibit, a pharmacist from dispensing HIV preexposure prophylaxis or HIV postexposure prophylaxis; and

c. Nothing in this section shall be construed to require a contract offered by a group or individual medical service corporation to provide coverage for HIV preexposure prophylaxis or HIV postexposure prophylaxis furnished by a pharmacist at an out-of-network pharmacy, unless the contract has an out-of-network pharmacy benefit.

d. The provisions of this section shall apply to all contracts in which the group or individual medical service corporation has reserved the right to change the premium.

e. As used in this section:

“HIV preexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

“HIV postexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

¹5. a. (1) Except as provided in paragraph (2) of this subsection, no group or individual health service corporation contract providing hospital or medical expense benefits shall be delivered, issued, executed, or renewed in this State or approved for issuance or renewal in this State by the Commissioner of Banking and Insurance, on or after the effective date of this act, unless the contract provides benefits to any subscriber or other person covered thereunder for HIV preexposure prophylaxis and HIV postexposure prophylaxis furnished without an individual prescription pursuant to the requirements of section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill) without requiring prior authorization or step therapy.

(2) If the federal Food and Drug Administration has approved one or more therapeutic equivalents of a drug, device, or product for the prevention of HIV and AIDS, paragraph (1) of this subsection shall not be construed to require the contract to cover all therapeutically equivalent versions without prior authorization or step therapy, if at least one version is covered without prior authorization or step therapy.

b. A contract offered by a group or individual health service corporation shall not:

(1) prohibit, or permit a delegated pharmacy benefits manager to prohibit, a pharmacist from dispensing HIV preexposure prophylaxis or HIV postexposure prophylaxis; and

c. Nothing in this section shall be construed to require a contract offered by a health service corporation to provide coverage for HIV preexposure prophylaxis or HIV postexposure prophylaxis furnished by a pharmacist at an out-of-network pharmacy, unless the contract has an out-of-network pharmacy benefit.

d. The provisions of this section shall apply to all contracts in which the health service corporation has reserved the right to change the premium.

e. As used in this section:

“HIV preexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

“HIV postexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

¹6. a. (1) Except as provided in paragraph (2) of this subsection, no individual health insurance policy providing hospital or medical expense benefits shall be delivered, issued, executed, or renewed in this State or approved for issuance or renewal in this State by the Commissioner of Banking and Insurance, on or after the effective date of this act, unless the policy provides benefits to any named insured or other person covered thereunder for HIV preexposure prophylaxis and HIV postexposure prophylaxis furnished without an individual prescription pursuant to the requirements of section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill) without requiring prior authorization or step therapy.

(2) If the federal Food and Drug Administration has approved one or more therapeutic equivalents of a drug, device, or product for the prevention of HIV and AIDS, paragraph (1) of this subsection shall not be construed to require the policy to cover all therapeutically equivalent versions without prior authorization or step therapy, if at least one version is covered without prior authorization or step therapy.

b. An individual health insurance policy shall not:

(1) prohibit, or permit a delegated pharmacy benefits manager to prohibit, a pharmacist from dispensing HIV preexposure prophylaxis or HIV postexposure prophylaxis; and

c. Nothing in this section shall be construed to require an individual health insurance policy to provide coverage for HIV preexposure prophylaxis or HIV postexposure prophylaxis furnished by a pharmacist at an out-of-network pharmacy, unless the contract has an out-of-network pharmacy benefit.

d. The provisions of this section shall apply to all policies in which the insurer has reserved the right to change the premium.

e. As used in this section:

“HIV preexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

“HIV postexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

¹7. a. (1) Except as provided in paragraph (2) of this subsection, no group health insurance policy providing hospital or medical expense benefits shall be delivered, issued, executed, or renewed in this State or approved for issuance or renewal in this State by the Commissioner of Banking and Insurance, on or after the effective date of this act, unless the policy provides benefits to any named insured or other person covered thereunder for HIV preexposure prophylaxis and HIV postexposure prophylaxis furnished without an individual prescription pursuant to the requirements of section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill) without requiring prior authorization or step therapy.

(2) If the federal Food and Drug Administration has approved one or more therapeutic equivalents of a drug, device, or product for the prevention of HIV and AIDS, paragraph (1) of this subsection shall not be construed to require the policy to cover all therapeutically equivalent versions without prior authorization or step therapy, if at least one version is covered without prior authorization or step therapy.

b. A group health insurance policy shall not:

(1) prohibit, or permit a delegated pharmacy benefits manager to prohibit, a pharmacist from dispensing HIV preexposure prophylaxis or HIV postexposure prophylaxis; and

c. Nothing in this section shall be construed to require a group health insurance policy to provide coverage for HIV preexposure prophylaxis or HIV postexposure prophylaxis furnished by a pharmacist at an out-of-network pharmacy, unless the contract has an out-of-network pharmacy benefit.

d. The provisions of this section shall apply to all policies in which the insurer has reserved the right to change the premium.

e. As used in this section:

“HIV preexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

“HIV postexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

¹8. a. (1) Except as provided in paragraph (2) of this subsection, every individual health benefits plan that is delivered, issued, executed, or renewed in this State pursuant to P.L.1992, c.161 (C.17B:27A-2 et seq.) or approved for issuance or renewal in this State, on or after the effective date of this act, shall provide benefits to any person covered thereunder for expenses incurred for HIV preexposure prophylaxis and HIV postexposure prophylaxis furnished without an individual prescription pursuant to the requirements of section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill) without requiring prior authorization or step therapy.

(2) If the federal Food and Drug Administration has approved one or more therapeutic equivalents of a drug, device, or product for the prevention of HIV and AIDS, paragraph (1) of this subsection shall not be construed to require the plan to cover all therapeutically equivalent versions without prior authorization or step therapy, if at least one version is covered without prior authorization or step therapy.

b. An individual health benefits plan shall not:

(1) prohibit, or permit a delegated pharmacy benefits manager to prohibit, a pharmacist from dispensing HIV preexposure prophylaxis or HIV postexposure prophylaxis; and

c. Nothing in this section shall be construed to require an individual health benefit plan to provide coverage for HIV preexposure prophylaxis or HIV postexposure prophylaxis furnished by a pharmacist at an out-of-network pharmacy, unless the contract has an out-of-network pharmacy benefit.

d. The provisions of this section shall apply to all health benefit plans in which the carrier has reserved the right to change the premium.

e. As used in this section:

“HIV preexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

“HIV postexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

¹9. a. (1) Except as provided in paragraph (2) of this subsection, every small employer health benefits plan that is delivered, issued, executed, or renewed in this State pursuant to P.L.1992, c.162 (C.17B:27A-17 et seq.) or approved for issuance or renewal in this State, on or after the effective date of this act, shall provide benefits to any person covered thereunder for HIV preexposure prophylaxis and HIV postexposure prophylaxis furnished without an individual prescription pursuant to the requirements of section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill) without requiring prior authorization or step therapy.

(2) If the federal Food and Drug Administration has approved one or more therapeutic equivalents of a drug, device, or product for the prevention of HIV and AIDS, paragraph (1) of this subsection shall not be construed to require the plan to cover all therapeutically equivalent versions without prior authorization or step therapy, if at least one version is covered without prior authorization or step therapy.

b. A small employer health benefits plan shall not:

(1) prohibit, or permit a delegated pharmacy benefits manager to prohibit, a pharmacist from dispensing HIV preexposure prophylaxis or HIV postexposure prophylaxis; and

c. Nothing in this section shall be construed to require a small employer health benefit plan to provide coverage for HIV preexposure prophylaxis or HIV postexposure prophylaxis furnished by a pharmacist at an out-of-network pharmacy, unless the contract has an out-of-network pharmacy benefit.

d. The provisions of this section shall apply to all health benefit plans in which the carrier has reserved the right to change the premium.

e. As used in this section:

“HIV preexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

“HIV postexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

¹10. a. (1) Except as provided in paragraph (2) of this subsection, notwithstanding any provision of law to the contrary, a certificate of authority to establish and operate a health maintenance organization in this State shall not be issued or continued by the Commissioner of Banking and Insurance on or after the effective date of this act unless the health maintenance organization provides health care services to any enrollee for expenses incurred for HIV preexposure prophylaxis and HIV postexposure prophylaxis furnished without an individual prescription pursuant to the requirements of section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill) without requiring prior authorization or step therapy.

(2) If the federal Food and Drug Administration has approved one or more therapeutic equivalents of a drug, device, or product for the prevention of HIV and AIDS, paragraph (1) of this subsection shall not be construed to require the plan to cover all therapeutically equivalent versions without prior authorization or step therapy, if at least one version is covered without prior authorization or step therapy.

b. A health maintenance organization shall not:

(1) prohibit, or permit a delegated pharmacy benefits manager to prohibit, a pharmacist from dispensing HIV preexposure prophylaxis or HIV postexposure prophylaxis; and

c. Nothing in this section shall be construed to require a health maintenance organization to provide coverage for HIV preexposure prophylaxis or HIV postexposure prophylaxis furnished by a pharmacist at an out-of-network pharmacy, unless the contract has an out-of-network pharmacy benefit.

d. The benefits shall be provided to the same extent as for any other medical condition under the contract.

e. As used in this section:

“HIV preexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

“HIV postexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

¹11. a. (1) Notwithstanding any State law or regulation to the contrary, and except as provided in paragraph (2) of this subsection, the Department of Human Services shall ensure that the provision of benefits for HIV preexposure prophylaxis and HIV postexposure prophylaxis furnished without an individual prescription pursuant to the requirements of section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill) to eligible persons under the Medicaid program, established pursuant to P.L.1968, c.413 (C.30:4D-1 et seq.), shall be provided without the imposition of any prior authorization or step therapy requirements.

(2) If the federal Food and Drug Administration has approved one or more therapeutic equivalents of a drug, device, or product for the prevention of HIV and AIDS, paragraph (1) of this subsection shall not be construed to require the department to ensure coverage of all therapeutically equivalent versions without prior authorization or step therapy, if at least one version is covered without prior authorization or step therapy.

b. As used in this section:

“HIV preexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

“HIV postexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

¹12. a. (1) Except as provided in paragraph (2) of this subsection, the State Health Benefits Commission shall provide benefits to each person covered under the State Health Benefits Program for expenses incurred for HIV preexposure prophylaxis and HIV postexposure prophylaxis furnished without an individual prescription pursuant to the requirements of section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill) without requiring prior authorization or step therapy.

(2) If the federal Food and Drug Administration has approved one or more therapeutic equivalents of a drug, device, or product for the prevention of HIV and AIDS, paragraph (1) of this subsection shall not be construed to require the contract to cover all therapeutically equivalent versions without prior authorization or step therapy, if at least one version is covered without prior authorization or step therapy.

b. The State Health Benefits Commission shall not:

(1) prohibit, or permit a delegated pharmacy benefits manager to prohibit, a pharmacist from dispensing HIV preexposure prophylaxis or HIV postexposure prophylaxis; and

c. Nothing in this section shall be construed to require the State Health Benefits Commission to provide coverage for HIV preexposure prophylaxis or HIV postexposure prophylaxis furnished by a pharmacist at an out-of-network pharmacy, unless the contract has an out-of-network pharmacy benefit.

d. The benefits shall be provided to the same extent as for any other medical condition under the contract.

e. As used in this section:

“HIV preexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

“HIV postexposure prophylaxis” means the same as that term is defined in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

¹13. The Commissioner of Human Services shall apply for such State plan amendments or waivers as may be necessary to implement the provisions of section 11 of this act and to secure federal financial participation for State Medicaid expenditures under the federal Medicaid program.¹

¹14. a. Within 90 days after the date of enactment of this act, and notwithstanding the provisions of the “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et seq.) to the contrary, the State Board of Pharmacy, in consultation with the Department of Health, immediately upon filing proper notice with the Office of Administrative Law, shall adopt rules and regulations as may be necessary to implement the provisions of this act.

¹[9.] 15.¹ This act shall take effect immediately.