ASSEMBLY, No. 687

STATE OF NEW JERSEY

219th LEGISLATURE

 

PRE-FILED FOR INTRODUCTION IN THE 2020 SESSION

 


 

Sponsored by:

Assemblywoman  VALERIE VAINIERI HUTTLE

District 37 (Bergen)

Assemblyman  DANIEL R. BENSON

District 14 (Mercer and Middlesex)

 

 

 

 

SYNOPSIS

     Authorizes pharmacists to dispense HIV prophylaxis without individual prescription under certain circumstances; mandates prescription benefits coverage.

 

CURRENT VERSION OF TEXT

     Introduced Pending Technical Review by Legislative Counsel.

  


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 shall 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 screens the patient and determines the exposure to HIV occurred 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 Clinical Laboratory Improvement Amendments of 1988, 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.

 

     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.).

 

     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.

 

     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).

     “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.

 

     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.

 

     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).

     “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.

 

     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.

     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).

     “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.

 

     9.    This act shall take effect immediately.

 

 

STATEMENT

 

     This bill authorizes pharmacists to dispense HIV prophylaxis without an individual prescription under certain circumstances and requires prescription benefits coverage for prophylaxis furnished under the bill.

     HIV prophylaxis is a course of treatment involving certain drug combinations that can prevent HIV infection notwithstanding exposure to the virus under circumstances in which it is normally transmitted, such as through unprotected sexual contact, sharing needles, or other contact with an infected person’s blood or bodily fluids.  HIV prophylaxis includes both HIV preexposure prophylaxis (PrEP), which is taken by a person who anticipates engaging in conduct that risks HIV infection, and HIV postexposure prophylaxis (PEP), which is taken by a person who may have been exposed to HIV.

     Under the bill, pharmacists will be permitted to furnish PrEP and PEP to patients without an individual prescription pursuant to a standing order issued by the Commissioner of Health or, if the commissioner is not a duly licensed physician, the Deputy Commissioner of for Public Health Services.  A standing order will be issued to a pharmacist upon request, provided that the pharmacist completes a training program approved by the State Board of Pharmacy in consultation with the Department of Health, and certifies that the pharmacist will meet the requirements set forth in the bill to furnish PrEP and PEP without an individual prescription.  The training program is to include information about financial assistance programs available to patients to assist with the costs of PrEP and PEP.

     The bill allows a patient to receive up to a 60-day supply of PrEP without an individual prescription in any given two-year period.  Thereafter, to continue receiving PrEP, the patient will be required to obtain a prescription for the drugs.  A pharmacist furnishing PrEP to a patient without an individual prescription will be required to document that the patient is HIV negative, as demonstrated by a test administered in the past seven days, and that the patient does not report any signs or symptoms of acute HIV infection.  If the patient does not have a current HIV test, the pharmacist may order a test.  If the patient tests positive for HIV, the pharmacist will be required to provide the patient with information and resources concerning HIV treatment and comply with State and federal requirements for a positive HIV test, which includes certain reporting requirements.

     Additionally, the pharmacist will be required to confirm that the patient is not taking any contraindicated medications, provide the patient with counseling on the ongoing use of PrEP, advise the patient that the patient will require a prescription to continue receiving PrEP, confirm the patient has not already been provided with a 60-day supply of PrEP without an individual prescription in the past two years, document the services provided, and notify the patient’s primary care provider that the patient was furnished with PrEP, unless the patient does not consent to the pharmacist providing this notice. 

     Pharmacists may furnish a complete course of PEP to a patient who may have been exposed to HIV if the pharmacist determines the exposure occurred within the previous 72 hours, the patient otherwise meets the clinical criteria for PEP consistent with guidelines published by the federal Centers for Disease Control and Prevention (CDC), the pharmacist tests the patient for HIV, the pharmacist counsels the patient on the use of PEP consistent with CDC guidelines, the pharmacist informs the patient of the availability of PrEP, and the pharmacist notifies the patient’s primary care provider the patient was furnished with PEP, unless the patient does not consent to the pharmacist providing this notice. 

     If a patient being furnished with PrEP or PEP does not have a primary care provider, or refuses to consent to the pharmacist providing notice to the primary care provider, the pharmacist will be required to provide the patient with a list of health care providers to contact regarding ongoing treatment using PrEP or followup care for PEP, as applicable.  The DOH will be required to publish and maintain a current list of providers for pharmacists to use for this purpose, which list may be made available on the department’s Internet website.

     In no case will a patient be authorized to waive the consultation required under the bill to receive PrEP or PEP without an individual prescription.

     The bill requires health benefits plans that include prescription benefits, as well as the State Employee’s Health Benefits Plan, the School Employees’ Health Benefits Plan, and Medicaid, to provide coverage for PrEP and PEP furnished under the bill without any prior authorization or step therapy requirements.  If therapeutic equivalents to prevent HIV and AIDS are approved, the health plans may apply prior authorization or step therapy requirements to other versions of the treatment, provided at least one version is covered without prior authorization or step therapy.  Health plans will not be authorized to prohibit a pharmacist from dispensing PrEP and PEP.  Health plans will not be required to provide coverage for PrEP furnished without an individual prescription in a quantity that exceeds a 60-day supply within a given two-year period.  Health plans will not be required to cover PrEP or PEP furnished by a pharmacist at an out-of-network pharmacy unless the plain includes an out-of-network pharmacy benefit.