Pharmacists’ Authority to Initiate PrEP and PEP and Engage in Collaborative Practice Agreements

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP 

CPA: Regulation permits pharmacist to enter into a CPA with a primary care provider 

• Alaska Admin. Code tit. 12, § 52.240
• Does CPA need to be patient-specific?
  • No, CPA does not need to be patient-specific.
  • The CPA must list the specific types of patients to which the pharmacist may provide services. This means a general population may be identified (rather than one specific patient).
• Are there filing requirements?
  • Yes, pharmacist must submit copy of agreement to Board of Pharmacy.
  • CPA is not effective until approved by Board of Pharmacy.
  • Primary care provider and pharmacist must each keep a written copy of CPA on file.
• Are there content requirements?
  • Yes, CPA must identify the following: 1) collaborating pharmacist; 2) collaborating primary care provider; 3) the time period in which the agreement will be in effect; and 4) description of scope of services covered under agreement.
  • Regarding the scope of services, the agreement must explicitly specify the decisions the pharmacist is authorized to make. This includes the types of diseases, drugs, or drug categories involved and the type of collaborative authority. The agreement must state the procedures, decision criteria, or plans the pharmacists are to follow when making therapeutic decisions, particularly when modification or initiation of drug therapy is involved.
  • All authority granted to the pharmacist must be within the primary care provider’s scope of practice.
  • Statute explicitly prohibits a CPA from giving a pharmacist authority to prescribe a controlled substance.
• Is there a time period limit?
  • Yes, CPA must be renewed no later than every 2 years.
• Is the pharmacist required to undergo additional training?
  • It depends. The Board of Pharmacy determines whether additional training is required based on the scope of services outlined in the submitted CPA.
  • If the Board of Pharmacy is not satisfied that the pharmacist has been adequately trained in the procedures outlined in the CPA, then the Board will require completion of specific additional training that covers those procedures. The pharmacist must then complete said training before the Board of Pharmacy approves CPA. 

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Alaska Stat. Ann. § 08.80.480
• Definition of scope of practice includes administration
• Administration explicitly includes drug administration by injection 

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes. Alaska Stat. Ann. § 08.80.337
  • Alaska statute defines the scope of pharmacy practice as “provision of patient counseling and the provision of those acts or services necessary to provide pharmaceutical care.”
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • No.

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes. Alaska Stat. Ann. § 21.07.250 recognizes pharmacists as providers
    • Does the law/regulation apply to specific services?
      • No, broad authority
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No.
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • No distinctions across payers.

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Ala. Code § 34-23-1
• Definition of scope of practice includes administration
• Definition of dispense includes administration

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• Ala. Code § 34-23-77
• Ala. Admin. Code 680-X-2-.44
• Does CPA need to be patient-specific?
  • Yes, CPA must be patient-specific. Patient (or patient representative) must sign a form agreeing to receiving health care services under a CPA.
• Are there filing requirements?
  • Yes, pharmacist and primary care provider must respectively submit copy of agreement to Board of Pharmacy and Board of Medical Examiners within 10 days of each party signing agreement.
  • CPA is not effective until approved by Board of Pharmacy and Board of Medical Examiners.
  • CPA may be subjected to fees by each Board. Fees from each Board may not exceed $300.
  • Amendments of CPA must go through same approval process as original CPA.
  • Pharmacist and primary care provider must each keep written copy of CPA on file.
• Are there content requirements?
  • Yes, CPA must identify the following: 1) collaborating pharmacist; 2) collaborating primary care provider; 3) date of the agreement; and 4) description of scope of services covered under agreement.
  • Statute explicitly prohibits a CPA from giving a pharmacist authority to prescribe a controlled substance.
• Is there a time period limit?
  • Yes, CPA must be renewed every 2 years.
• Is the pharmacist required to undergo additional training?
  • No, pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Alabama Public Health, Bureau of Provider Standards, available at https://www.alabamapublichealth.gov/providerstandards/clia.html
  • Yes, as long as the pharmacy submits the CMS 1116 Form, it may apply for approval by the Alabama Department of Public Health to perform any CLIA-waived test, including HIV and hepatitis point-of-care test
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • No, any CLIA-waived test for which the pharmacy submits the CMS 1116 Form may be provided.

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes
  • Ala. Admin. Code 560-X-16-.06: “Medicaid may reimburse for professional services provided by licensed pharmacists. Professional services may include vaccine administration, medication maintenance therapy adherence and other clinical services as designated by the Agency.
    • Does the law/regulation apply to specific services?
      • Yes, the law allows Medicaid to reimburse for “professional services” provided by licensed pharmacists, including “vaccine administration, medication maintenance therapy adherence and other clinical services as designated by the Agency.”
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No.
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Statute gives pharmacists the authority to independently initiate PrEP or PEP (Passed 3/21/23)

• H.B. 1007 (Ark. 2023).
• AR Pharmacist-Initiated PrEP Statewide Protocol
• Arkansas Code § 17-92-101(17)(A)(i)(g) and (26)
• Arkansas Code § 17-92-115
• Arkansas Code § 23-92-506(b)(6) and (7)
• Code Ann. § 23-99-1120
• Does the pharmacist need a standing order from a primary care provider?
  • No, a pharmacist does not need a standing order from a primary care provider.
  • Pharmacists are required to inform a patient’s primary care provider if the pharmacist prescribes PrEP or PEP. If the patient does not have a primary care provider, then the pharmacist must provide a list of local primary care providers.
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • Yes, insurers are prohibited from requiring prior authorization or step therapy to cover PrEP and PEP.
• Is there a quantity limit for prescriptions?
  • Yes, pharmacists are limited to prescribing up to a 60-day supply (with a requirement of prescribing at least a 30-day supply) of PrEP or one complete 28-day course of PEP.
• Does the pharmacist have to undergo additional training?
  • Yes, pharmacists must complete a training program approved by the Arkansas State Board of Pharmacy. The training must include information on the use of PrEP and PEP and financial assistance for PrEP and PEP.

INJECTABLE PrEP/CABROTEGRAVIR: Limited authority to administer injectable PrEP

• Ark. Code Ann. § 17-92-101
• Prescription must have explicit instructions from a primary care provider to administer
  • Must either be a patient-specific standing order, prescription, or general protocol from a primary care provider

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• Ark. Code Ann. § 17-92-101(17)(A)(i)(e), (ix)(a)
• Does CPA need to be patient-specific?
  • Yes, CPA must be patient-specific
• Are there filing requirements?
  • No, there are no filing requirements.
• Are there content requirements?
  • Yes, the CPA must state the specific act of drug therapy management or disease state management the primary care provider is delegating to the pharmacist.
  • CPA may authorize pharmacist to engage in drug therapy management. This may include the prescribing, dispensing, and administration of explicitly identified drugs.
• Is there a time period limit?
  • No, there is not a time period limit for the CPA.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes, the statewide protocol authorizing pharmacists to initiate PrEP and PEP specifically authorizes pharmacists to administer rapid HIV tests. AR Pharmacist-Initiated PrEP Statewide Protocol
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • Yes, pharmacists are limited to CLIA-waived rapid HIV tests.

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Ariz. Rev. Stat. Ann. § 32-1901
• Definition of scope of practice includes administration
• Administration explicitly includes drug administration by injection

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• Ariz. Rev. Stat. Ann. § 32-1970
• Does CPA need to be patient-specific?
  • No, CPA does not need to be patient-specific.
  • The CPA must list of the specific types of patients to which the pharmacist may provide services. This means a general population may be identified (rather than one specific patient).
  • A primary care provider must have an established provider-patient relationship with a patient before a pharmacist may provide services to that patient under a CPA.
  • A primary care provider includes a nurse practitioner.
• Are there filing requirements?
  • No, there are not filing requirements.
  • Pharmacist must keep a written copy of the CPA on file, which the Board of Pharmacy may request a copy of at any time.
• Are there content requirements?
  • Yes, CPA must outline the duties related to drug therapy and disease management that the pharmacist is authorized to perform, including drug therapy that the pharmacist may initiate, monitor and modify and laboratory tests that the pharmacist may order.
  • For drug therapy, the CPA must also identify the specific drug, drugs or drug classes and the conditions to be managed by the pharmacist.
  • CPA must state the conditions and events for which the pharmacist must notify the primary care provider.
• Is there a time period limit?
  • No, there is not a time period limit for the CPA.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Statute gives pharmacists the authority to independently initiate PrEP and PEP (Enacted October 2019; Expanded January 2024)

• S.B. 159, (Cal. 2019)
• S.B. 339, (Cal. 2024)
• Cal. Bus. & Prof. Code § 4052.02 and .03
• Cal. Health & Safety Code § 1342.74
• Cal. Ins. Code § 10123.1933
• Cal. Welf. & Inst. Code § 14132.968
• Does the pharmacist need a standing order from a primary care provider?
  • No, the pharmacist does not need a standing order from a primary care provider.
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • Yes, the law expands the Medi-Cal schedule of benefits to include PrEP and PEP as pharmacist services, so low-income individuals can receive PrEP and PEP prescribed by a pharmacist with little to no cost-sharing.
  • The legislation requires private insurance companies to cover PrEP and PEP prescribed by a pharmacist and restricts insurers from requiring patients to obtain prior authorization or step therapy to obtain PrEP or PEP.
  • Health care service plans are also required to cover all pharmacist services and laboratory tests related to initiating PrEP and PEP.
• Is there a quantity limit for prescriptions?
  • Yes, there is a quantity limit for prescriptions. Pharmacists are permitted to prescribe up to a 90-day supply of PrEP in a two-year period or a full 28-day regimen of PEP.
  • However, a pharmacist may prescribe beyond a 90-day supply of PrEP if certain conditions are met. A pharmacist seeking to furnish PrEP beyond a 90-day supply must ensure the following: 1) the patient receives testing and follow-up care consistent with CDC guidelines, 2) services provided by the pharmacist are recorded in the patient’s record and maintained in the pharmacy’s record system, and 3) the patient’s primary care provider is notified of the pharmacists compliance with all statutory requirements relating to prescribing PrEP. If the patient does not have a primary care provider, then the pharmacist must provide a list of local primary care providers.

• Does the pharmacist have to undergo additional training?
  • Yes, the law requires pharmacists to undergo additional training.
  • To initiate PrEP or PEP, pharmacists must complete a training program approved by the California State Board of Pharmacy. The training must include information on the use of PrEP and PEP, HIV prevention, interpreting HIV tests, and linking individuals to primary care.

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Cal. Bus. & Prof. Code § 4016
• Cal. Bus. & Prof. Code § 4052
• Definition of scope of practice includes administration
• Administration explicitly includes drug administration by injection

CPA: Statute permits a pharmacist to enter into a CPA with a primary care provider

• Cal. Bus. & Prof. Code § 4052(a)(13)
• Does CPA need to be patient-specific?
  • No, CPA does not need to be patient-specific.
• Are there filing requirements?
  • No, there are not filing requirements
• Are there content requirements?
  • No, there are not content requirements.
  • CPA may authorize pharmacists to initiate, adjust, or discontinue drug therapy.
  • A pharmacist may enter into a CPA with any health care provider with prescriptive authority.
• Is there a time period limit?
  • No, there is not a time period limit.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes. Ann.Cal.Bus. & Prof.Code § 1206.6; Ann.Cal.Bus & Prof Code § 4052.4; Ann.Ca.Bus & Prof Code § 1209
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • Yes, in community pharmacy settings, pharmacists may only perform blood glucose, hemoglobin A1c, or cholesterol tests that are classified as waived under CLIA
  • In pharmacies located in health care settings with a lab onsite, pharmacists may perform a broader number of CLIA-waived tests including STI tests and kidney and liver function tests, as long as it does not require the use of specimens collected by vaginal swab, venipuncture, or the collection of seminal fluid
  • A pharmacy with a laboratory director of a laboratory with a CLIA waiver may provide any CLIA waived test

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes. Cal. Health & Safety Code § 1368.5; Cal. Ins. Code § 10125.1.
    • Does the law/regulation apply to specific services?
      • No.
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • Yes. Every health care service plan that offers coverage for a service that is within a pharmacist’s scope of practice must reimburse the pharmacist at a rate equal to what the insurer would reimburse a primary care provider for the same service.
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Law applies to all health insurance carriers.

ORAL PrEP: Pharmacists may prescribe and dispense PrEP and PEP pursuant to a statewide protocol. (Passed July 2020; Updated via Statewide Protocol November 2023)

• Colorado PrEP Statewide Protocol
• H.B. 20 – 1061, (Colo. 2020)
• Colo. Rev. Stat. Ann. § 10-16-102(27.5), (38.5), (50.5), and (50.7)
• Colo. Rev. Stat. Ann. § 10-16-104 (18)(e)
• Colo. Rev. Stat. Ann. § 10-16-152 
• Colo. Rev. Stat. Ann. § 12-280-103(39)(c)(II)(C), (39)(d), and (39)(e)
• Colo. Rev. Stat. Ann. § 12-280-125.7
• Colo. Rev. Stat. Ann. § 25-1-130
• 3 Colo. Code Regs. § 719-1:17.00.00
• Does the pharmacist need a standing order from a primary care provider?
  • No, a pharmacist does not need a standing order from a primary care provider.
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • Yes, health insurance providers are prohibited from requiring step therapy or prior authorization for PrEP and PEP.
  • Private insurance plans are required to cover PrEP and PEP prescribed by a pharmacist and pay a consultative fee to pharmacists for prescribing PrEP or PEP.
• Is there a quantity limit for prescriptions?
  • No, Colorado’s law does not impose quantity limits on pharmacy-initiated PrEP nor limit the frequency with which pharmacists can prescribe PrEP or PEP to a given patient.
• Does the pharmacist have to undergo additional training?
  • Yes, the law requires pharmacists to undergo additional training.
  • To initiate PrEP or PEP, pharmacists must complete an ACPE-accredited course approved by the Colorado State Board of Pharmacy.

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Colo. Rev. Stat. Ann. § 12-280-103
• Definition of scope of practice includes administration
• Administration explicitly includes drug administration by injection

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• Colo. Rev. Stat. Ann. § 12-280-601, 602
• Does CPA need to be patient-specific?
  • No, CPA does not need to be patient-specific.
  • A primary care provider must have an established provider-patient relationship with a patient before a pharmacist may provide services to that patient under a CPA.
• Are there filing requirements?
  • No, there are not filing requirements.
• Are there content requirements?
  • Yes, the CPA must specify the treatment protocol the primary care provider is delegating to the pharmacist.
  • CPA must establish a means for the primary care provider and pharmacist to communicate and document changes to the patient's medical record.
  • “Primary care provider” includes advanced practice registered nurses.
  • CPA must also be in writing and signed by primary care provider and pharmacist.
• Is there a time period limit?
  • No, there is not a time period limit.
• Is the pharmacist required to undergo additional training?
  • No, but the pharmacist must carry professional liability insurance and devote a portion of their pharmacy practice to collaborative pharmacy practice.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes. Colo. Rev. Stat. § 12-280-103. Colorado PrEP Statewide Protocol
    • Colorado defines “pharmacist care services” as “patient care activities provided by a pharmacist, with or without dispensing a drug, that are intended to achieve outcomes related to curing or preventing disease, eliminating or reducing a patient's symptoms, or arresting or slowing the process of a disease.”
    • Statewide Protocol authorizing pharmacists to independently initiate PrEP and PEP specifically authorizes pharmacists to perform HIV-related CLIA-waived tests.
  • Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
    • No

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes. See Colorado Medicaid Provider Manual, Pharmacy Services, https://hcpf.colorado.gov/pharm-serv
    • Does the law/regulation apply to specific services?
      • Applies to “medically necessary” services provide by a pharmacist
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Statute gives pharmacists the authority to independently initiate PrEP and PEP. (Enacted July 2023)

• S.B. 1102, (Conn. 2023)
• Conn. Gen. Stat. Ann. § 20-633f
• Does the pharmacist need a standing order from a primary care provider?
  • No, the pharmacist does not need a standing order from a primary care provider.
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • No, legislation does not address pharmacist’s reimbursement or other insurance provisions.
• Is there a quantity limit for prescriptions?
  • Yes, there is a quantity limit for prescriptions. Pharmacists are permitted to prescribe up to a 60-day supply of PrEP in a two-year period or a full 30-day regimen of PEP.
• Does the pharmacist have to undergo additional training?
  • Yes, the law requires pharmacists to undergo additional training.
  • To initiate PrEP or PEP, pharmacists must complete a training program approved by the Connecticut State Board of Pharmacy that covers the following: 1) obtaining a patient’s complete sexual; 2) delivering a positive HIV-related test result to a patient and offering information on care services available to such patient; 3) using PrEP for patients who have tested negative for HIV.

INJECTABLE PrEP/CABROTEGRAVIR: Pharmacist’s scope of practice does not include authority to administer injectable PrEP. A pharmacist seeking to administer injectable PrEP would need to do so under the terms of a CPA.

• Conn. Gen. Stat. Ann. § 20-571
• Scope of practice includes ability to dispense
• Dispense explicitly excludes the ability to administer drugs, which includes injectable prescription drugs

CPA: Statute permits a pharmacist to enter into a CPA with a primary care provider

• Conn. Gen. Stat. Ann. § 20-631
• Does CPA need to be patient-specific?
  • No, CPA does not need to be patient-specific.
  • The CPA must list of the specific types of patients to which the pharmacist may provide services. This means a general population may be identified (rather than one specific patient).
  • A primary care provider must have an established provider-patient relationship with a patient before a pharmacist may provide services to that patient under a CPA.
• Are there filing requirements?
  • No, there are no filing requirements.
  • CPA must be made available to the Department of Consumer Protection and the Department of Public Health upon request.
  • A written copy of the CPA must be held within the medical file of each patient receiving services pursuant to the CPA.
• Are there content requirements?
  • Yes, CPA must identify the specific drug, drugs or drug classes and the conditions to be managed by the pharmacist.
  • CPA must identify the laboratory tests that the pharmacist may order.
  • All services the pharmacist provides pursuant to the CPA must be documented in the relevant patient’s medical file.
  • When a pharmacist discontinues drug therapy or deprescribes a drug pursuant to their authority to do so under a CPA, the pharmacist must notify the primary care provider within 24 hours.
  • CPA may authorize pharmacist to initiate, modify, continue, discontinue or deprescribe a drug therapy, or initiate, continue or discontinue use of, or deprescribe, a device, that has been prescribed for a patient, order associated laboratory tests and administer drugs.
• Is there a time period limit?
  • No, there is not a time period limit.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes. Conn. Gen. Stat. Ann. § 20-633f.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • Yes, pharmacists are limited to administering HIV-related CLIA-waived tests. Pharmacists must also first meet the following requirements: 1) complete a CLIA application for certification for the HIV-related test and the Department of Public Health has approved such application; 2) complete the training course required by pharmacists seeking to initiate PrEP and PEP; 3) ensure the patient receiving the test is either 18 years or older or is 12 years or older with the consent of their legal guardian (or is an emancipated minor over the age of 12).

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Administration of injectable PrEP is prohibited

• D.C. Code Ann. § 3-1201.02
• Pharmacist’s authority to administer medication extends only to immunizations and vaccines

CPA: Statute permits a pharmacist to enter into a CPA with a primary care provider

• D.C. Mun. Regs. tit. 17, § 10001
• D.C. Code Ann. § 3-1202.08(h)(1)
• Does CPA need to be patient-specific?
  • No, CPA does not need to be patient-specific.
  • A physician must have a valid patient-physician relationship prior to referring a patient to a pharmacist for participation in a CPA.
• Are there filing requirements? 
  • No, there are no filing requirements.
  • The Boards may deny approval of a physician or pharmacist to participate in a collaborative practice agreement if the physician or pharmacist has 1) a final order by the governing Board disciplining the physician or pharmacist's license for a practice issue within the 5 years immediately preceding the formation of the agreement; or 2) limitations placed on the physician or pharmacist's license by the governing board.
• Are there content requirements? 
  • Yes, the CPA must include 1) specification of the drug therapy to be provided and any tests that may be necessarily incident to its provision; 2) the conditions for initiating, modifying, or discontinuing a drug therapy; and 3) directions concerning the monitoring of a drug therapy, including the conditions that would warrant a modification to the dose, dosage regime, or dosage form of the drug therapy.
• Is there a time period limit? 
  • No, there are no time period limits.
• Is the pharmacist required to undergo additional training? 
  • Yes, to participate in a CPA, a pharmacist must possess relevant advanced training, complete a residency or a certificate program, and complete 3 (for Doctor of Pharmacy) or 5 (for Bachelor of Science in Pharmacy) years of relevant clinical experience.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes. District of Columbia D.C. Code § 3-1201.02
    • “Practice of pharmacy” definition includes “conducting health screenings, including obtaining finger-stick blood samples”
  • Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
    • No

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Del. Code Ann. tit. 24, § 2502
• Definition of scope of practice explicitly includes administration of injectable drugs
• Pharmacist must notify patient’s primary care provider (if patient designated one) within 72 hours of injection administration.

CPA: Statute permits a pharmacist to enter into a CPA with a primary care provider

• Del. Code Ann. tit. 24, § 2502
• Does CPA need to be patient-specific?
  • No, CPA does not need to be patient-specific.
• Are there filing requirements?
  • No, there are no filing requirements.
• Are there content requirements?
  • Yes, the CPA must list the nature, scope, conditions, and limitations of the services the pharmacist may provide under the agreement.
  • The agreement must also be in writing and signed by both the participating pharmacist and primary care provider.
• Is there a time period limit?
  • No, there is not a time period limit.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Ye. Delaware Del. Code tit. 24, § 2502
    • The “practice of pharmacy” includes “performing and interpreting capillary blood tests to screen and monitor disease risk factors or facilitate patient education, the results of which must be reported to the patient’s health-care practitioner; screening results to be reported only if outside normal limits” as well as “ordering, performing, and interpreting” CLIA waived tests.
  • Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
    • No

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Pharmacists may prescribe and dispense PEP pursuant to a pursuant to a non-patient specific standing order (Enacted July 2024)

• H.B. 159, (Fla. 2024)
• Fla. Stat. Ann. § 465.1861 
• Does the pharmacist need a standing order from a primary care provider?
  • Yes, a pharmacist must have a non-patient specific standing order from a physician that is provided through a collaborative practice agreement with the same physician.
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • No, legislation does not address pharmacist’s reimbursement or other insurance provisions.
• Is there a quantity limit for prescriptions?
  • No, Florida’s law does not impose quantity limits on pharmacy-initiated PEP nor limit the frequency with which pharmacists can prescribe PEP to a given patient.
• Does the pharmacist have to undergo additional training?
  • Yes, a pharmacist must complete a course approved by the Florida Board of Pharmacy that covers the following: 1) performance of patient assessments; 2) point-of-care testing procedures; 3) safe and effective treatment of HIV exposure with HIV infection prevention drugs, including, but not limited to, consideration of the side effects of the drug dispensed and the patient's diet and activity levels; 4) identification of medication contraindications; and 5) identification of patient comorbidities in individuals with HIV requiring further medical evaluation and treatment, including, but not limited to, cardiovascular disease, lung and liver cancer, chronic obstructive lung disease, and diabetes mellitus.
  • Pharmacists must also have professional liability insurance coverage of at least $250,000.

INJECTABLE PrEP/CABROTEGRAVIR: Pharmacist may only administer injectable PrEP if under the authority of a CPA with a primary care provider

• Fla. Stat. Ann. § 465.003
• Fla. Stat. Ann. § 465.0125

CPA: Statute permits a pharmacist to enter into a CPA with a primary care provider

• Fla. Stat. Ann. § 465.1865
• Fla. Admin. Code Ann. r. 64B16-31.001
• Fla. Admin. Code Ann. r. 64B16-31.003
• Fla. Admin. Code Ann. r. 64B16-31.005 
• Fla. Admin. Code Ann. r. 64B16-31.007 
• Fla. Admin. Code Ann. r. 64B16-31.009
• Does CPA need to be patient-specific?
  • No, CPA does not need to be patient specific.
• Are there filing requirements?
  • Yes, the pharmacist must submit a signed copy of the CPA to the Board of Pharmacy before the CPA may be implemented.
• Are there content requirements?
  • Yes, CPA must include: 1) the patient’s name, 2) each chronic health condition to be managed, 3) the specific drugs to be managed, 4) circumstances under which the pharmacist may perform laboratory or clinical tests, 5) events for which the pharmacist must notify the collaborating physician and the manner and timeframe of such notification, 6) beginning and end dates for the CPA and termination procedures, and 7) a statement that the CPA may be terminated by either party at any time.
  • A CPA created for the purpose of granting a pharmacist the authority to initiate and dispense PEP must contain the following information: 1) the terms and conditions relating to the screening for HIV and the ordering and dispensing of PEP by the pharmacist; 2) the specific populations of patients the pharmacist is authorized to screen for HIV and for whom the pharmacist may order and dispense PEP; 3) a requirement that the pharmacist maintain records for PEP ordered and dispensed under the collaborative practice agreement; 4) the physician's instructions for obtaining relevant patient medical history for the purpose of identifying disqualifying health conditions, adverse reactions, and contraindications to the use of PEP; 4) process and schedule for the physician to review the pharmacist's records and actions under the CPA; 5) evidence of the pharmacist's current certification by the board as provided in subsection.
• Is there a time period limit?
  • Yes, CPA automatically terminates after 2 years unless renewed.
• Is the pharmacist required to undergo additional training?
  • Yes, a pharmacist who enters into a CPA must complete 8 hours of continuing education.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No. Florida Fla. Stat. § 465.1895
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • No

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Ga. Code Ann. § 26-4-4
• Ga. Code Ann. § 26-4-5 
• Definition of scope of practice includes administration
• Broad definition of administration that includes provision of drug pursuant to a prescription order interpreted to include injectable prescription drug

CPA: Statute permits a pharmacist to enter into a CPA with a primary care provider

• Ga. Code Ann. § 43-34-24
• Ga. Code Ann. § 26-4-50
• Ga. Comp. R. & Regs. 480-35-.02 through .07
• Does CPA need to be patient-specific?
  • Yes, the CPA needs to be patient-specific (see content requirements – the protocol must identify each patient for whom the pharmacist is authorized to modify drug therapy).
• Are there filing requirements?
  • Yes, a pharmacist must apply to the Board for certification which will allow them to enter into a CPA.
• Are there content requirements?
  • Yes, CPA must include 1) the name and signature of the pharmacist and physician who are parties to the agreement, 2) the date the CPA was established and becomes effective, 3) the length of time the protocol shall be effective, 4) the physician’s diagnosis, 5) the identity of each patient for whom the pharmacist is authorized to modify drug therapy, 6) description of the specific responsibilities and parameters for modification of drug therapy, 7) the medication the pharmacist may modify including minimum and maximum dosage levels, and 8) a statement that each patient must be notified that the pharmacist is authorized to modify their drug therapy.
• Is there a time period limit?
  • Yes, CPA shall not be valid for more than 2 years from the date of issue.
• Is the pharmacist required to undergo additional training?
  • Yes, the pharmacist must annually successfully complete a continuing education program regarding modification of drug therapy and approved by the board.
  • In order to renew the pharmacist’s certification, their continuing education must (1) be from a provider approved by the Board pursuant to Rule 480-3-.03 or a provider approved by ACPE; 2) have been taken and credit received for the continuing education during the 12 months preceding the application for renewal; 3) have been from a live program at least 1.0 contact hour in length; and 4) have been on the topic of the therapy area in which the pharmacist seeks to make drug therapy modifications.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes. GA Code § 26-4-4
  • “Practice of pharmacy” definition includes “performing capillary blood tests and interpreting the results as a means to screen for or monitor disease risk factors and facilitate patient education, and a pharmacist performing such functions shall report the results obtained from such blood tests to the patient's physician of choice.”
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • No

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Haw. Rev. Stat. Ann. § 461-1
• Definition of scope of practice explicitly includes administration of injectable drugs

CPA: Statute permits a pharmacist to enter into a CPA with a primary care provider.

• Haw. Rev. Stat. Ann. § 461-1 (would fall under the definition of “practice of pharmacy”)
• Does CPA need to be patient-specific?
  • No, the CPA does not need to be patient-specific.
• Are there filing requirements?
  • It depends. If the CPA authorizes pharmacist to initiate emergency contraception, the Board of Pharmacy must approve the agreement.
• Are there content requirements?
  • No, there are no specific content requirements.
  • A pharmacist may be authorized to perform the following services: ordering or performing routine drug therapy; ordering drug therapy-related lab tests; initiating emergency contraception oral drug therapy; administering drugs orally, topically, by intranasal delivery, or by injection, pursuant to the order of the patient's licensed physician; administering certain vaccines and immunizations; initiating or adjusting a patient’s drug regimen; transmitting prescriptions to another pharmacist for the purpose of filling or dispensing; providing consultation, information, or education to patients and health care professionals; and prescribing or dispensing an opioid antagonist.
• Is there a time period limit?
  • No, there is no time period limit.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No. Hawaii Haw. Code R. § 461-1
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • NA

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes, Hawaii Medicaid Provider Manua, available at https://humanservices.hawaii.gov/wp-content/uploads/2022/07/Attachment-4-Rev.-9.2021-4.19-Bje07.13.22.pdf
    • Does the law/regulation apply to specific services?
      • Applies to “other licensed provider services” provided by a licensed pharmacist
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Iowa Code Ann. § 155A.3
• Definition of scope of practice includes dispensing
• Dispensing includes drug administration
• Administration explicitly includes drug administration by injection

CPA: Statute permits a pharmacist to enter into a CPA with a primary care provider.

• Iowa Code Ann. § 155A.48
• IAC 657— 39.13(155A)
• Does CPA need to be patient-specific?
  • No, the CPA does not need to be patient-specific.
• Are there filing requirements?
  • No, there are no filing requirements.
• Are there content requirements?
  • Yes, the CPA must identify the following: 1) the collaborating pharmacist and primary care provider; 2) the nature, scope, conditions, and limitations of the patient care and drug therapy management services to be provided by a pharmacist; 3) the specific drugs the pharmacist may provide; 4) a description of the process to monitor compliance with the agreement and clinical outcomes of patients; 5) the effective date of the agreement; 6) the process for terminating the agreement. The agreement must then be signed by both parties.
• Is there a time period limit?
  • Yes, the primary care provider and the pharmacist must review and make any desired amendments to the CPA every two years.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes. Iowa Code section 155A.46
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • Pharmacists may provide point of care testing and treatment for influenza, streptococcus A, and COVID-19 as well as point-of-care testing at the point of interaction between a pharmacist and a patient in response to a public health emergency.

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes, Iowa Medicaid Provider Manual, https://hhs.iowa.gov/ime/providers/tools-trainings-and-services/medicaid-initiatives/medicaid-pharmaceutical-care-management
    • Does the law/regulation apply to specific services?
      • Only pharmaceutical care management services for complex patients.
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Idaho Code Ann. § 54-1705 
• Definition of scope of practice includes administration
• Administration is interpreted to be included within the definition of dispense

CPA: Regulation permits a pharmacist to enter into a CPA with a primary care provider.

• Idaho Admin. Code r. 24.36.01.351 (emergency rule)
• Does CPA need to be patient-specific?
  • No, the CPA does not need to be patient-specific.
• Are there filing requirements?
  • No, there are no filing requirements.
• Are there content requirements?
  • Yes, the CPA must identify the parties to the agreement, the pharmacist's scope of practice authorized, and if necessary, any monitoring parameters
• Is there a time period limit?
  • No, there is no time period limit.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes. Idaho Code § 54-1704
    • Includes CLIA-waived tests under definition of “practice of pharmacy.”
  • Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
    • No

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes, Idaho Medicaid Provider Manual, available at https://www.idmedicaid.com/General%20Information/General%20Information%20and%20Requirements%20for%20Providers.pdf
    • Does the law/regulation apply to specific services?
      • Applies to “medical services” provided by licensed pharmacist
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Pharmacists may prescribe and dispense PrEP and PEP pursuant to a non-patient specific standing order (1/1/23)

• H.B. 4430 (Ill. 2022)
• S.B. 1344 (Ill. 2023)
• 305 Ill. Comp. Stat. Ann. 5/5-5.12d
• 225 Ill. Comp. Stat. Ann. 85/3, 85/43.5
• 215 Ill. Comp. Stat. Ann. 5/356z.45
• 215 Comp. Stat. Ann. 5/356z.60
• Does the pharmacist need a standing order from a primary care provider?
  • Yes, a pharmacist needs a non-patient specific standing order issued by a licensed physician or the medical director of a county or local health department.
  • Pharmacists are required to inform a patient’s primary health care provider of any services related to the initiation and dispensing of PrEP or PEP. If a patient does not have a primary health care provider, then the pharmacist must give a list of primary health care providers or clinics in the area.
  • Pharmacists may also prescribe pursuant to a non-patient specific standing order issued by the Illinois Department of Public Health. However, the Illinois Department of Public Health has yet to issue such a standing order.
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • Yes, reimbursement for PrEP and PEP-related services is required to be 85% of what the rate would be if these same services had been provided by a primary care provider.
  • Any accident and health insurance issued or renewed after January 1, 2024, is required to provide coverage for PrEP and PEP.
• Is there a quantity limit for prescriptions?
  • No, Illinois law does not impose quantity limits on pharmacy-initiated PrEP nor limit the frequency with which pharmacists can prescribe PrEP or PEP to a given patient.
• Does the pharmacist have to undergo additional training?
  • Yes, pharmacists seeking to initiate and dispense PrEP and PEP must first complete an educational training program related to PrEP and PEP that is accredited by the ACPE or Department of Financial and Professional Regulation.

INJECTABLE PrEP/CABROTEGRAVIR: Administration of injectable PrEP is prohibited

• 225 Ill. Comp. Stat. Ann. 85/3
• Administration is explicitly limited to only five listed prescription drug types. Injectable PrEP does not fall into one of these five type of injectable drugs, and pharmacists are, therefore, prohibited from administration.

CPA: Statute permits a pharmacist to enter into a CPA with a primary care provider for the provision of PrEP and PEP for eligible patients.

•  225 Ill. Comp. Stat. Ann. 85/43.5 (specific to HIV PrEP/PEP; CPA standing order)
• Does CPA need to be patient-specific?
  • No, the CPA does not need to be patient-specific.
  • A pharmacist may only initiate PrEP or PEP for patients whose test results are nonreactive. Patients with reactive test results must be referred to an appropriate health care professional or clinic.
• Are there filing requirements?
  • No, there are no filing requirements.
• Are there content requirements?
  • Yes, the pharmacist must communicate the services that will be provided to the patient and the patient’s primary care provider. If the patient does not have a PCP, the pharmacist shall give the patient a list of providers in the area.
  • The services provided must be documented and retained in a confidential manner consistent with state HIV confidentiality requirements.
• Is there a time period limit?
  • No, there is not a time period limit.
• Is the pharmacist required to undergo additional training?
  • Yes, a pharmacist shall complete an educational training program accredited by the Accreditation Council for Pharmacy Education and approved by the Department that is related to the initiation, dispensing, or administration of drugs, laboratory tests, assessments, referrals, and consultations for PrEP and PEP.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes. Illinois 225 Ill. Comp. Stat. § 85/3
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • Statute specifically authorizes provision of CLIA-waived tests for PrEP and PEP initiation as well as ordering and administration of tests and screenings for influenza, SARS-COV 2, and “health conditions identified by a statewide public health emergency, as defined in the Illinois Emergency Management Agency Act.”

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Ind. Code Ann. § 25-26-13-2
• Definition of scope of practice includes administration
• Administration explicitly includes drug administration by injection

CPA: Statute permits a pharmacist to enter into a CPA with a primary care provider.

• Ind. Code Ann. § 25-26-13-2
• Ind. Code Ann. § 25-26-16-4.5
• Ind. Code Ann. § 155A.48
• Does CPA need to be patient-specific?
  • Yes, the protocols developed under a CPA need to be patient-specific, but they may apply to a single patient or a group of patients.
• Are there filing requirements?
  • No, there are no filing requirements.
• Are there content requirements?
  • Yes, the CPA must define the nature, scope, conditions, and limitations of the patient care and drug therapy management services to be provided by a pharmacist in order to ensure that a patient achieves the desired outcomes.
• Is there a time period limit?
  • No, there is no time period limit.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • NA

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Only for services authorized under recently passed Indiana statute allowing pharmacists to deliver birth control without a prescription. Indiana HB 1568, https://iga.in.gov/legislative/2023/bills/house/1568
    • Does the law/regulation apply to specific services?
      • Yes, birth control
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Pharmacist may only administer injectable PrEP if under the authority of a CPA with a primary care provider

• Kan. Stat. Ann. § 65-1626a

CPA: Statutes permit a pharmacist to enter into a CPA (or “Collaborative Drug Therapy Management” (CDTM)) with a primary care provider.

• Kan. Stat. Ann. § 65-1626a
• Kan. Admin. Regs. 68-7-22
• Does CPA need to be patient-specific?
  • Yes, the CPA needs to be patient-specific.
  • A pharmacist shall not provide CDTM to a patient if the pharmacist knows that the patient is not being treated by the same physician who has signed the CPA.
• Are there filing requirements?
  • Yes, the collaborating pharmacist must submit a copy of the CPA to the Board of Pharmacy within 5 business days of the agreement being signed by all parties.
• Are there content requirements?
  • Yes, CPA must define the nature, scope, conditions, and limitations of the patient care and drug therapy management services to be provided by a pharmacist.
  • CPA must be signed by the participating physician and pharmacist.
  • CPA must include: 1) the general methods, procedures, and decision criteria that the pharmacist must follow, 2) the procedures the pharmacist must use to document the CDTM decisions made by the pharmacist, 3) the procedures that the pharmacist is to follow to communicate to the physician changes in the patient’s condition and each CDTM decision made by the pharmacist, 4) situations in which the pharmacist is required to initiate contact with the physician, and 5) the procedures to be followed by the pharmacist if an urgent situation involving a patient's health occurs.
  • The pharmacist must contact the physician within 48 hours of making any changes to the patient’s treatment.
• Is there a time period limit?
  • Yes, CPA must be reviewed and updated every 2 years.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes. K.S.A. 65-16,131
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • Pharmacists may initiate test and treat under statewide protocol for flu, strep, and UTI.

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Ky. Rev. Stat. Ann. § 315.010
• Definition of scope of practice includes administration
• Administration explicitly includes drug administration by injection

CPA: Statute permits a pharmacist to enter into a “collaborative care agreement” (CCA) with a primary care provider.

• Ky. Rev. Stat. Ann. § 315.010(5)
• 201 Ky. Admin. Regs. 2:220
• Does CPA need to be patient-specific?
  • No, the patient does not need to be patient-specific. However, the pharmacist must document each patient (and the patient’s identifiable info) receiving care under the CPA.
  • Patients' drug-related health care needs must fall within the practitioner's or practitioners' statutory scope of practice.
  • Patients must be referred by the practitioner or practitioners to the pharmacist or pharmacists.
• Are there filing requirements?
  • No, there are no filing requirements.
• Are there content requirements?
  • Yes, CPA must: 1) identify the physician(s) and pharmacist(s) who are parties to the agreement, 2) specify the drug-related regimen to be provided, and how drug therapy is to be monitored, 3) stipulate the conditions for initiating, continuing, or discontinuing drug therapy and the conditions which warrant modifications to dose, dosage regimen, dosage form, or route of administration, 4) be in writing, 5) be signed and dated by each practitioner and pharmacist who is a party to the CCA, 6) provide the method for referral of patients to be managed under the CCA, 7) state the method for terminating the CCA, 8) contain the protocol, criteria, standing orders, or other method by which services are authorized, 9) contain the method established for the assessment of patient outcomes, if appropriate, and 10) indicate the lab tests that may be ordered.
  • Documentation relating to the care and course of therapy of the patient pursuant to the agreement shall be documented in the patient's record maintained by the pharmacist, provided to the collaborating practitioner, and be readily available to other healthcare professionals providing care to the patient.
• Is there a time period limit?
  • No, there is no time period limit.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Pharmacists may prescribe and dispense PrEP and PEP pursuant to a statewide protocol. (Passed June 2024)

• H.B. 579, (La. 2024)
• La. Stat. Ann. § 37:1218.2
• Does the pharmacist need a standing order from a primary care provider?
  • No, the pharmacist does not need a standing order from a primary care provider.
  • Pharmacists are required to inform a patient’s primary health care provider of any services related to the initiation and dispensing of PEP. If a patient does not have a primary health care provider, then the pharmacist must give a good faith effort to refer the patient to a primary care provider.
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • Yes, reimbursement for PrEP and PEP-related services is required to be equal to what the rate would be if these same services had been provided by a primary care provider.
• Is there a quantity limit for prescriptions?
  • Yes, pharmacists are limited to prescribing up to a 30-day supply of PrEP and a complete course of PEP.
• Does the pharmacist have to undergo additional training?
  • Yes, a pharmacist must complete a training course approved by the Louisiana Department of Health that addresses the use of PrEP and PEP and covers the following: 1) financial assistance programs for PrEP and PEP and 2) strategies to access state and federal resources to provide the same level of care for patients regardless of insurance coverage status.

INJECTABLE PrEP/CABROTEGRAVIR: Limited authority to administer injectable PrEP

• La. Stat. Ann. § 37:1164
• 46 La. Admin. Code Pt LIII, 521
• Pharmacist is required to undergo additional training in order to administer medications, which includes injectable drugs. Pharmacist must complete an ACPE-approved certificate program for medication administration that provides at least 20 hours of instruction and experiential training on the following areas: 1) standards for medication administration practices; 2) basic immunology; 3) recommended medication administration schedules; 4) medication storage and management; 5) informed consent; physiology and techniques for medication administration; 6) pre- and post-administration assessment and counseling; 7) medication administration record management; and 8) management of adverse events, including identification and appropriate response, as well as documentation and reporting.

CPA: Statute permits a pharmacist to participate in “collaborative drug therapy management (CDTM)” with a primary care provider.

• La. Admin Code. tit. 46, Pt LIII, § 523
• Does CPA need to be patient-specific?
  • Yes, the order needs to be patient-specific.
• Are there filing requirements?
  • Yes, a pharmacist must apply to the Board of Pharmacy for registration to engage in a CPA.
• Are there content requirements?
  • Yes, the contents of a CPA are limited to: 1) monitoring and modifying disease-specific drug therapy, 2) collecting and reviewing patient history, 3) obtaining and reviewing vital signs, including pulse, temperature, blood pressure, and respiration, 4) ordering, evaluating, and applying lab results (but the pharmacist may not interpret such test results or formulate a diagnosis), and 5) providing disease-specific counseling and education.
  • The physician must sign a written set of instructions (“order set”) that contains, at a minimum, the: 1) pharmacist and physician, and their contact information, 2) patient’s name, address, gender, date of birth, and telephone number, 3) disease or condition to be managed, 4) disease-specific drug or drugs to be utilized, 5) type and extent of drug therapy management the physician authorizes the pharmacist to perform, 6) specific responsibilities of the pharmacist and physician, 7) procedures, criteria, or plan the pharmacist is required to follow, 8) specific lab or other tests, if any, the physician authorizes the pharmacist to perform, 9) reporting and documentation requirements of the pharmacist and physician, 10) conditions and events in which the pharmacist and physician are required to notify each other, and 11) procedures to accommodate immediate consultation by telephone or direct telecommunication with, between, or among the pharmacist, physician, and the patient.
  • The order must include a predetermined range of medication set by the physician.
• Is there a time period limit?
  • Yes, the pharmacist must reapply to engage in a CPA each year.
  • A pharmacist’s registration to engage in CDTM shall terminate in the event of any of the following: 1) the pharmacist’s or physician’s death, 2) the pharmacist’s loss of license, 3) disciplinary action limiting the pharmacist’s ability to participate in CDTM, 4) notification to the Board of Pharmacy that the pharmacist has withdrawn from CDTM, 5) a finding by the Board of any cause that would render the pharmacist ineligible for registration, or 6) expiration of the pharmacist’s license or registration to engage in CDTM.
  • The order set shall be reviewed annually by the collaborating physician, or more frequently as deemed necessary.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes, the statewide protocol authorizing pharmacists to initiate PrEP and PEP specifically authorizes pharmacists to administer rapid HIV tests. Stat. Ann. § 37:1218.2
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • Yes, pharmacists are limited to CLIA-waived rapid HIV tests. Pharmacists providing rapid HIV tests are required to administer the tests in a private, secured location.

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes, limited.
  • pdf (lamedicaid.com)
    • Does the law/regulation apply to specific services?
      • Administering immunizations (influenza, hepatitis, HPV, etc.)
      • Family planning items/services
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Administration of injectable PrEP is prohibited

• 247 Mass. Code Regs. 2.00
• https://www.mass.gov/doc/2020-15-scope-of-practice-docx/download
• Pharmacists are explicitly permitted to only administer four types of vaccines/injections. Injectable PrEP does not fall into one of these four types.

CPA: Statute permits a pharmacist to enter into a CPA with a primary care provider.

• Mass. Gen. Laws Ann. ch. 112, § 24B ½
• Mass. Gen. Laws Ann. ch. 112, § 24B ¾
• 247 Mass. Code Regs. 16.02 through .04
• Does CPA need to be patient-specific?
  • Yes, the CPA needs to be patient-specific.
• Are there filing requirements?
  • No, there are not filing requirements.
  • The pharmacist must maintain a copy of the agreement, including copies of patient referral and patient consent, in the primary practice setting, readily retrievable at the request of the Board of Registration in Pharmacy and Board of Registration in Medicine.
  • The physician must maintain the original of the agreement, including the patient referral and patient consent, in the patient’s medical record in the custody of the supervising physician.
• Are there content requirements?
  • Yes, there are content requirements – which depend on the pharmacy setting.
  • In the community pharmacy setting, the CDTM agreement shall include: 1) a written referral of a specific patient from the supervising physician to an authorized pharmacist; and 2) the written consent of the patient to the CDTM agreement.
  • In all practice settings, the agreement shall include: 1) specific disease states being co-managed including identification as primary or co-morbid, 2) specific pharmacist prescribing authority pursuant to the agreement, 3) detailed practice protocols, 4) description of risk management activities, 5) documentation of any initiation, modification or discontinuation of a patient’s medication in the patient’s permanent medical record, 6) description of outcome measurements, 7) detailed informed consent procedures, and 8) detailed procedures and periods by which time any test results, copies of initial prescriptions, modifications or discontinuances, copies of the patient consent and the agreement, and other patient information will be forwarded by the pharmacist to the physician, and a specific procedure for the pharmacist to identify and transmit any urgent communications; description of the nature and form of the supervision of the pharmacist by the physician, and a description of the procedure to follow when either the pharmacist or physician is unavailable or absent.
• Is there a time period limit?
  • Yes, the CPA must be renewed every two years.
• Is the pharmacist required to undergo additional training?
  • Yes, the pharmacist must complete, in each year of the term of the CPA, at least 5 additional contact hours of Board-approved continuing education that address areas of practice generally related to the particular CPA.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes, very limited.
  • Microsoft Word - PHM Regs.docx (mass.gov)
  • MassHealth-Pharmacy-Covered-Professional-Services-List (conduent.com)
    • Does the law/regulation apply to specific services?
      • The MassHealth Pharmacy Covered Professional Services List specifies certain services that may be provided by a pharmacy provider and payable through the Pharmacy Online Processing System (POPS). Services include the administration of numerous vaccines, including influenza, COVID-19, hepatitis A and B, HPV, and many others.
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Administration of injectable PrEP is prohibited

• Md. Code Ann., Health Occ. § 12-101
• Md. Code Ann., Health Occ. § 12-509
• Administration is explicitly limited to only certain listed prescription drug types. Injectable PrEP does not fall into one of these types of injectable drugs, and pharmacists are, therefore, prohibited from administration. 
• While pharmacists are permitted to administer injectable drugs for the treatment of sexually transmitted infections, they are not permitted to administer injectable drugs for the prevention of sexually transmitted infections.

CPA: Statute permits a pharmacist to enter into a CPA (“physician-pharmacist agreement”) with a primary care provider.

• Md. Code Ann., Health-Gen. § 19-713.6
• Md. Code Regs. 10.34.29.03 through .07
• Does CPA need to be patient-specific?
  • It depends. A general CPA does not need to be patient-specific. However, a CPA specifically concerned with drug therapy management must be patient-specific.
• Are there filing requirements?
  • Yes, the pharmacist must submit a copy of the agreement and any subsequent modifications to the State Board of Pharmacy.
  • The physician must submit a copy of the agreement and any subsequent modifications to the State Board of Physicians.
  • Modifications to the agreement shall be registered with the Board of Pharmacy within 30 days.
  • The Board of Pharmacy requires a $100 fee per agreement.
• Are there content requirements?
  • Yes, the agreement must contain: 1) names and signatures of the physicians with prescriptive authority and pharmacists authorized to act under the contract, 2) locations where the pharmacist may provide services, 3) titles of the protocols to which the agreement pertains, 4) methods and time frames by which documentation and routine communication will occur between the physicians and the pharmacists, including the time frames in which the pharmacist will fully update the patient’s record in writing, 5) name, address, and telephone number of the party to the agreement who is to receive correspondence from the Boards related to the agreement, 6) statement that the physicians and pharmacists shall comply with all State and federal laws relating to patient confidentiality, and 7) list of devices available to the pharmacists performing under the agreement, which are relevant to the disease-states or conditions to be managed.
  • The therapy management contract shall contain: 1) list of allowable substitutions of chemically dissimilar drugs, if any, 2) statement that none of the parties have been coerced, given economic incentives, or are involuntarily required to participate in the contract, 3) statement that the pharmacist shall notify the prescribing provider if the pharmacist modifies the dose or agent under the contract, or detects an abnormal result from an assessment activity, 4) notice to the patient stating that the patient may terminate the contract at any time and the procedure by which they may terminate, 5) procedure for periodic review of drugs by the prescribing provider, 6) reference to the protocol(s) under which the pharmacist shall act, and 7) exceptions or limitations to the protocol(s) for the specific patient.
• Is there a time period limit?
  • No, there is no time period limit.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes. MD ADC 10.10.03.02
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • A pharmacist may obtain a letter of exception that allows them to independently perform the following CLIA-waived tests in a medical laboratory: whole blood glucose, Prothrombin Time/International Normalized Ratio, blood lipid for cholesterol, whole blood lead testing, and urine drug screens.

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes, but very vague and non-specific.
  • Professional Services Provider Manual 2022 web.pdf (maryland.gov)
  • PBM PORTAL (mdhrxprograms.com) (see Provider Manual link on this page – downloads a Word document)
    • Does the law/regulation apply to specific services?
      • Unclear
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Pharmacists may prescribe and dispense PrEP and PEP pursuant to a pursuant to a pursuant to a non-patient specific standing order (Enacted 6/18/21)

• LD 1115 (Maine, 2021).
• Me. Rev. Stat. tit. 22, § 3174-M
• Me. Rev. Stat. tit. 24-A, § 4317-D
• Me. Rev. Stat. tit. 32, § 13702-A(28)
• Me. Rev. Stat. tit. 32, § 13786-E
• Does the pharmacist need a standing order from a primary care provider?
  • Yes, the pharmacist needs a non-patient specific standing order from a primary care provider.
  • [The law authorizes the Maine Board Pharmacy to establish a statewide protocol that would enable pharmacists in the state to independently furnish PrEP and PEP. However, the State Board of Pharmacy has yet to do so.]
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • Yes, insurance companies are required to cover PrEP and PEP prescribed by pharmacists without prior authorization or step therapy for the time period pharmacists are permitted to prescribe PrEP and PEP.
• Is there a quantity limit for prescriptions?
  • Yes, pharmacists are limited to prescribing up to 60 days of PrEP in a two-year period and one complete, 28-day course of PEP.
• Does the pharmacist have to undergo additional training?
  • Yes, the pharmacist is required to first complete a training course approved by the State Board of Pharmacy that covers the following: 1) the use of protocols developed by the board for dispensing an HIV prevention drug; 2) the requirements for any laboratory testing for HIV infection and on guidelines for prescription adherence; and 3) best practices to counsel patients prescribed an HIV prevention drug.

INJECTABLE PrEP/CABROTEGRAVIR: Limited authority to administer injectable PrEP

• Me. Rev. Stat. tit. 32, § 13702-A
• Pharmacist may only administer drugs, including injectable prescription drugs, in compliance with a treatment protocol established by a licensed practitioner. A copy of the original treatment protocol and any subsequent revisions to the treatment protocol must be kept on file.

CPA: Statute permits a pharmacist to enter into a CPA with a primary care provider.

• Me. Rev. Stat. tit. 32, § 13843
• Code Me. R. tit. 02-392 Ch. 39-A, § 3
• Does CPA need to be patient-specific?
  • No, the CPA does not need to be patient-specific.
• Are there filing requirements?
  • Yes, the pharmacist must submit a copy of the CPA to the Board of Pharmacy before the agreement is effective.
• Are there content requirements?
  • Yes, CPA must contain: 1) A provision stating that activity in the initial 3 months of a CPA, the pharmacist is limited to monitoring drug therapy (the CPA may then be expanded to include initiating, administering, monitoring, modifying, and discontinuing a patient’s drug therapy), 2) identification and signatures of the parties to the CPA, the dates the agreement is signed, and the beginning and ending dates of the period the agreement is in effect, 3) a provision allowing either party to cancel the CPA by written notification, 4) site at which the collaborative practice will occur, 5) qualifications of the participants in the CPA, 6) a detailed description of the types of diseases, drugs, or drug categories involved and collaborative drug therapy management allowed in each patient’s case, 7) a procedure for referring each patient to the practitioner, 8) a plan for measuring and assessing patient outcomes, 9) require that all parties maintain professional liability insurance that covers the CPA, 10) treatment protocol(s) that will be utilized, 11) a provision stating that the CPA will terminate immediately in the event that the pharmacist no longer holds an unrestricted pharmacist license and immediately when the pharmacist knows or should know that the nurse practitioner no longer holds an unrestricted license, 12) a provision stating that the CPA will terminate upon the death of a party to the agreement, and 13) specify how the continuity of care for patients will be handled in the event that the CPA suddenly terminates.
  • The collaborating pharmacist and primary care provider must establish a procedure for reviewing and revising the agreement. Any amendments must be documented, signed, and dated.
• Is there a time period limit?
  • No, there is no time period limit, but the CPA must contain beginning and ending dates.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests. The legislation authorizing pharmacists to initiate PrEP and PEP authorizes pharmacists to order HIV-related laboratory tests but does not permit the independent administration of HIV-related CLIA-waived tests. Rev. Stat. tit. 32, § 13786-E
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Pharmacist may only administer injectable PrEP if under the authority of a CPA with a primary care provider

• Mich. Comp. Laws Ann. § 333.17707
• Mich. Comp. Laws Ann. § 333.17703
• Scope of practice includes dispense
• Dispensing medication must be pursuant to a prescription or other authorization issued by a prescriber 

CPA: N/A

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes.
    • pdf (michigan.gov)
    • pdf (state.mi.us)
      • Does the law/regulation apply to specific services?
        • Pharmacists can be reimbursed for providing MTM services.
      • Does the law /regulation require parity (or equity) between pharmacists and other providers?
        • No
      • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
        • Medicaid

ORAL PrEP: Pharmacists may prescribe and dispense PrEP and PEP pursuant to a statewide protocol (Passed June 2024; Statewide Protocol must be established prior to 1/1/25)

• H.F. 5247, (Minn. 2024).
• Minn. Stat. Ann. § 151.37
• Does the pharmacist need a standing order from a primary care provider?
  • No, the pharmacist does not need a standing order from a primary care provider.
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • Yes, insurers are prohibited from requiring prior authorization or step therapy to cover PrEP and PEP.
  • However, a health plan is not required to cover all the therapeutically equivalent versions of PrEP and PEP without prior authorization or step therapy, if
    at least one therapeutically equivalent version is covered without prior authorization or step
  • Starting 1/1/26 pharmacists will also be defined as healthcare providers (solely for the purpose of initiating PrEP and PEP). This means that insurers will be required to reimburse pharmacists for clinical services provided related to initiating PrEP and PEP. Minn. Stat. Ann. § 151.01
• Is there a quantity limit for prescriptions?
  • No, Minnesota law does not impose quantity limits on pharmacy-initiated PrEP nor limit the frequency with which pharmacists can prescribe PrEP or PEP to a given patient.
• Does the pharmacist have to undergo additional training?
  • Yes, pharmacists prescribing and dispensing PrEP and PEP must complete a course approved by the ACPE or the Minnesota State Board of Pharmacy regarding the use of PrEP and PEP for HIV-negative persons.

INJECTABLE PrEP/CABROTEGRAVIR: Pharmacist may only administer injectable PrEP if under the authority of a CPA with a primary care provider

• Minn. Stat. Ann. § 151.01

CPA: Statute permits a pharmacist to enter into a CPA with a primary care provider.

• Minn. Stat. Ann. § 151.01(subd. 27)
• Does CPA need to be patient-specific?
  • No, the CPA does not need to be patient-specific.
• Are there filing requirements?
  • No, there are no filing requirements.
• Are there content requirements?
  • No, there are no content requirements.
• Is there a time period limit?
  • No, there is no time period limit.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes. Minn. Stat. Ann. § 151.01(subd. 27)
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • No, but the pharmacist may not modify drug therapy as a result of the clinical test without a CPA.

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes.
    • Pharmacy Services (state.mn.us)
    • 256B.0625 MN Statutes
    • Medication Therapy Management Services (MTMS) (state.mn.us)
      • Does the law/regulation apply to specific services?
        • Pharmacists can be reimbursed for providing family planning services and supplies, administering vaccines, and providing MTM services.
      • Does the law /regulation require parity (or equity) between pharmacists and other providers?
        • No
      • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
        • Medicaid

ORAL PrEP: Pharmacists may prescribe and dispense PEP pursuant to a non-patient specific standing order. (Enacted February 2023)

• Mo. Ann. Stat. § 338.730
• Mo. Code Regs. Ann. tit. 20, § 2220-6.024
• Does the pharmacist need a standing order from a primary care provider?
  • Yes, a pharmacist needs a non-patient specific standing order issued by a licensed physician.
  • Pharmacists are required to inform a patient’s primary health care provider of any services related to the initiation and dispensing of PEP. If a patient does not have a primary health care provider, then the pharmacist must give a list of primary health care providers or clinics in the area.
  • [Pharmacists may also prescribe pursuant to a standing order issued by the Director of the Missouri Department of Health and Senior Services. However, the Director of the Missouri Department of Health and Senior Services has yet to issue such a standing order.]
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • No, legislation does not address pharmacist’s reimbursement or other insurance provisions.
• Is there a quantity limit for prescriptions?
  • Yes, there is a quantity limit for prescriptions. Pharmacists may prescribe a full 28-day regimen of PEP, but is limited to only doing so twice within a two year period for a given patient.
• Does the pharmacist have to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

INJECTABLE PREP/CABROTEGRAVIR: Pharmacist may only administer injectable PrEP if under the authority of a CPA with a primary care provider

• Mo. Ann. Stat. § 338.010

CPA: Statute permits a pharmacist to enter into a CPA (“written protocol”) with a primary care provider.

• Mo. Ann. Stat. § 338.010 
• Mo. Code Regs. Tit. 20 § 2150-5.024
• Mo. Code Regs. Ann. tit. 20, § 2150-5.028
• Mo. Code Regs. Ann. tit. 20, § 2150-5.029
• Mo. Code Regs. Ann. tit. 20, § 2220-6.025
• Does CPA need to be patient-specific?
  • Yes, the protocol needs to be patient-specific.
• Are there filing requirements?
  • Yes, the collaborating pharmacist must submit proof of successful completion of a board-approved course of academic clinical study to the state board of pharmacy before entering into a CPA.
• Are there content requirements?
  • Yes, the CPA must include the following: 1) the identity and signatures of the physician and pharmacist; 2) effective dates; 3) a statement of clinical conditions, diagnoses, diseases, and specific drugs or drug categories included in the protocol and the type of medication therapy services allowed in each case; 4) a statement of the methods, procedures, decision criteria, and plan the pharmacist is to follow when conducting medication therapy services; 5) procedures for documenting decisions made by the pharmacist and a plan for communication, feedback, and reporting to the physician; 6) a mechanism and procedure that allows the physician to override, rescind, modify, or otherwise amend the protocol; 7) a statement that the pharmacist shall not delegate their responsibility to another person; 8) a description of any authority granted to the pharmacist to administer any drug or medication including the identification of any such drug, medication, or device; 9) a description of drug therapy related patient assessment procedures or testing that may be ordered or performed by the pharmacist, including lab testing; 10) provisions for allowing the pharmacist to access the patient’s medical records; 11) a provision for providing the physician access to patient records for medication therapy services provided by the pharmacist for patients of the authorizing physician; 12) provisions establishing a course of action the pharmacist is authorized to follow to address emergency situations; 13) criteria for timely communication between the physician and pharmacist; 14) notification requirements; and 15) the method for reviewing the pharmacist’s work by the physician.
  • HIV PEP protocols must, at a minimum, include the following: 1) directions/guidelines for patient assessment and counseling; 2) authorized drug therapies to be dispensed, including the specified dosage regimen and forms; 3) authorized route(s) of administration; 4) Specific requirements for referring patients to a healthcare provider for additional evaluation/treatment; 5) any patient counseling requirements designated by the authorizing physician; and 6) any documentation or recordkeeping required by the authorizing physician. Protocols must be signed and dated by the authorizing physician and the authorized pharmacist.
• Is there a time period limit?
  • Yes, the CPA must be reviewed and signed by the pharmacist and the physician every year.
  • Prescription orders can be valid for no more than 1 year.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from independently providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes. 
  • Pharmacy Manual (momed.com)
    • Does the law/regulation apply to specific services?
      • Yes, pharmacists can be reimbursed for participating in the MTM program, administering vaccines, and providing diabetes self-management training.
      • MO pharmacy providers can no longer bill for long-acting reversible contraceptives (e.g., implants, IUDs).
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Miss. Code. Ann. § 73-21-73
• Definition of scope of practice includes administration
• Administration explicitly includes drug administration by injection

CPA: Statute permits a pharmacist to enter into a CPA (“written guideline” or “protocol”) with a primary care provider.

• 30 Code Miss. R. Pt. 2630, R. 2.3
• 30 Code Miss. R. Pt. 2630, R. 2.4
• Does CPA need to be patient-specific?
  • Yes, the CPA needs to be patient-specific.
• Are there filing requirements?
  • Yes, the CPA must be filed with the Mississippi State Board of Pharmacy and Mississippi State Board of Medical Licensure.
• Are there content requirements?
  • Yes, the CPA must: 1) identify the physician who agrees to supervise the pharmacist and the scope of the physician's active practice, 2) describe the specific responsibilities authorized by the physician, 3) describe the method the pharmacist shall use to document decisions or recommendations they make to the physician, 4) describe the patient activities the physician requires the pharmacist to monitor, 5) describe the types of reports the physician requires the pharmacist to report and the schedule by which they are to submit these reports, 6) include a statement of the medication categories and the type of initiation and modification of drug therapy that the physician authorizes the pharmacist to perform, 7) describe the procedures or plan the pharmacist shall follow if they exercise initiation and modification of drug therapy, 8) indicate the date the agreement ends, 9) be dated and signed by the pharmacist(s) and physician(s), 10) include a statement that the patient has been notified by the pharmacist(s) and physician(s) that an agreement exists, an 11) includes a statement which certifies that the physician(s) have advised their respective malpractice liability carriers concerning the protocol, and that any potential liability that may ensue as a result of implementing the agreement shall be covered by those policies or endorsements.
  • The above content requirements apply to agreements authorizing care and consultation with a patient, agreements authorizing initiation and/or modification of prescription drug therapy, and agreements authorizing lab work.
  • The CPA must be signed on each patient.
• Is there a time period limit?
  • Yes, the duration of the CPA cannot be longer than one year.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes.
  • Administrative Code (ms.gov)
    • Does the law/regulation apply to specific services?
      • Yes, pharmacists can be reimbursed for disease state management services, including patient evaluation and education, drug therapy review, and other disease state management activities.
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

Miss. Code. Ann. § 73-21-73(ii): “Provider” or “primary health care provider” includes a pharmacist who provides health care services within his or her scope of practice pursuant to state law and regulation.

• This codification as a provider is most-likely key for reimbursement under standing order or CPA

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Pharmacist may only administer injectable PrEP if under the authority of a CPA with a primary care provider

• Mont. Code Ann. § 37-7-101

CPA: Statute permits a pharmacist to enter into a CPA with a primary care provider.

• Mont. Admin. R. 24.174.524
• Does CPA need to be patient-specific?
  • No, the CPA does not need to be patient-specific.
• Are there filing requirements?
  • No, there are no filing requirements, but the pharmacist must maintain a written copy of the agreement that is available for inspection by the Board of Pharmacy.
• Are there content requirements?
  • Yes, the CPA must include 1) identification of the practitioner(s) who are parties to the agreement; 2) the types of decisions that the pharmacist is allowed to make; 3) a method for the practitioner to monitor compliance with the agreement and clinical outcomes and to intercede where necessary; 4) a provision allowing the practitioner to override a decision made by the pharmacist if the practitioner deems it necessary or appropriate; 5) a provision allowing either party to cancel the agreement by written notification; 6) an effective date; 7) signatures of collaborating pharmacists and practitioners, or a representative from the medical practice or clinic that is authorized to represent its practitioners, who are party to the agreement, as well as dates of signing; and 8) a procedure for periodic review and renewal within a clinically-appropriate timeframe.
• Is there a time period limit?
  • No, there is no time period limit.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP:  Statewide standing order gives immunizing pharmacists the authority to independently initiate PEP (not PrEP) (Effective since March 2022)

• H.B. 96 (N.C. 2021)
• NC PEP Statewide Standing Order
• N.C. Gen. Stat. Ann. § 90-85.15B
• N.C. Gen. Stat. Ann. § 90-85.3(i1)
• Does the pharmacist need a standing order from a primary care provider?
  • No, the pharmacist does not need a standing order from a primary care provider.
  • The standing order authorizing pharmacists to prescribe PEP was signed by the North Carolina State Health Director and was effective immediately upon signing.
  • Pharmacists are required to inform a patient’s primary care provider within 72 hours of prescribing PEP. If the patient does not have a primary care provider, then the pharmacist must provide a list of local primary care providers.
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • No, North Carolina law does not address pharmacist’s reimbursement or other insurance provisions regarding PrEP and PEP related services.
• Is there a quantity limit for prescriptions?
  • No, North Carolina law does not impose quantity limits on pharmacy-initiated PrEP nor limit the frequency with which pharmacists can prescribe PrEP or PEP to a given patient.
• Does the pharmacist have to undergo additional training?
  • It depends. The standing order only permits “immunizing pharmacists” to prescribe PEP. To be qualified as an immunizing pharmacist in North Carolina, a pharmacist must: 1) hold CPR certification issued by the American Heart Association or the American Red Cross, or an equivalent certification; 2) complete a vaccine administration certificate program that is accredited by the CDC, ACPE, or a similar health authority or professional body approved by the Board of Pharmacy; 3) maintain documentation of three hours of continuing education every two years, designed to maintain competency in the disease states, drugs, and vaccine administration; 4) complete training approved by the Division of Public Health's Immunization Branch for participation in the North Carolina Immunization Registry; 5) notify the North Carolina Board of Pharmacy and the North Carolina Medical Board of immunizing pharmacist status; and 6) administer vaccines, long-acting injectable medications, or immunizations.

INJECTABLE PrEP/CABROTEGRAVIR: Limited authority to administer injectable PrEP

• N.C. Gen. Stat. Ann. § 90-85.3A
• N.C. Gen. Stat. Ann. § 90-85.3
• N.C. Gen. Stat. Ann. § 90-85.15B
• Definition of scope of practice includes administration, subject to certain requirements
• Administration explicitly includes drug administration by injection
• An immunizing pharmacist may administer a long-acting injectable medication to an adult pursuant to a patient-specific prescription if the following requirements are met: 1) keep on file a record of the patient and drug administration and 2) notify within 72 hours the provider who wrote the prescription whether the drug was administered.

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• N.C. Gen. Stat. Ann. § 90-85.3A
• N.C. Gen. Stat. Ann. § 90-18(c)(3a)
• N.C. Gen. Stat. Ann. § 90-18.4
• 21 N.C. Admin. Code 46.3101
• Does CPA need to be patient-specific?
  • Yes, the CPA must be patient-specific.
• Are there filing requirements?
  • Yes, the pharmacist must receive approval from the Board of Pharmacy to engage in a CPA. To receive approval, the pharmacist must submit an application and corresponding fee as well as a signed copy of the CPA to the Board.
  • If the pharmacist and primary care practitioner terminate CPA, the Board of Pharmacy must be notified within 10 days of the agreement’s termination.
  • Pharmacist must keep a written copy of CPA on file, which must be made available to the Board of Pharmacy upon request.
  • Initial application fee is $100, and annual renewal fee is $50.
• Are there content requirements?
  • Yes, CPA must identify the following: 1) collaborating pharmacist; 2) collaborating primary care provider; and 3) description of scope of services covered under agreement.
  • Regarding the scope of services, the agreement must explicitly specify the decisions the pharmacist is authorized to make. This includes the types drugs or drug categories involved and the type of collaborative authority.
  • CPA must be disease-specific.
  • Pharmacist and primary care practitioner must each sign CPA.
  • CPA must include a statement prohibiting the pharmacist from substitution of a chemically dissimilar drug product by the CPA for the product prescribed by the primary care practitioner without first obtaining written consent of the primary care practitioner.
  • For the first six months following the date the CPA goes into effect, the pharmacist and primary care practitioner must meet monthly to discuss services provided pursuant to CPA. Following the first six month, the pharmacist and primary care practitioner must meet every six months to discuss services provided pursuant to CPA.
  • CPA must require patient be notified of CPA’s existence and contents.
• Is there a time period limit?
  • Yes, the CPA and the pharmacist’s authority to engage in a CPA must be reviewed by the Board of Pharmacy once a year.
• Is the pharmacist required to undergo additional training?
  • Yes, the pharmacist is required to undergo and provide proof to the Board of Pharmacy of 35 hours of practice-relevant continuing education each year.
  • A pharmacist must have a certain number of years’ experience in the practice of pharmacy based on the pharmacist’s level of education. A pharmacist must meet one of the three following criteria to engage in a CPA:
    1. Certification from the Board of Pharmaceutical Specialties, is a Certified Geriatric Pharmacist as certified by the Commission for Certification in Geriatric Pharmacy, or has completed an American Society of Health System Pharmacists (ASHP) accredited residency program with two years of Clinical Experience approved by the Board of Pharmacy.
    2. Holds the academic degree of Doctor of Pharmacy, has three years of Clinical Experience approved by the Boards, and has completed a North Carolina Center for Pharmaceutical Care (NCCPC) or ACPE-approved certificate program in the area of practice covered by the CPA.
    3. Holds the academic degree of Bachelor of Science in Pharmacy, has five years of Clinical Experience approved by the Boards, and has completed two NCCPC or ACPE approved certificate programs with at least one program in the area of practice covered by the CPA.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Limited authority to administer injectable PrEP

• N.D. Admin. Code 61-04-11-02
• N.D. Admin. Code 61-04-11-04
• N.D. Admin. Code 61-04-11-07
• To be eligible for drug administration, a pharmacist must be certified through an ACPE-approved course for drug administration.
• Pharmacist must receive a written protocol from a primary care provider that identified the following information: 1) identity of the practitioner issuing the order; 2) identity of the patient to receive the injection; 3) identity of the medication and dose to be administered; and 4) date of the original order and the dates or schedule, if any, of each subsequent administration.
• Pharmacist must also have a private space to administer injections.

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• N.D. Cent. Code Ann. § 43-15-31.4
• Does CPA need to be patient-specific?
  • No, CPA does not need to be patient-specific.
• Are there filing requirements?
  • No, there are not filing requirements.
  • Pharmacist must make a copy of CPA available to Board of Pharmacy upon request.
• Are there content requirements?
  • Yes, CPA must require pharmacist to document any services provided to the patient pursuant to the CPA in said patient’s medical file.
  • CPA must include a provision that requires the pharmacist to immediately notify the primary care practitioner if the pharmacist initiates or modifies a drug therapy.
  • CPA may authorize pharmacist to have limited prescriptive practices to initiate or modify drug therapy following diagnosis or established protocols by a primary care practitioner.
  • “Primary care practitioner” includes an advanced practice registered nurse.
• Is there a time period limit?
  • No, there is not a time period limit.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes. N.D. Admin. Code 61-04-10-06.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • Yes, the following tests are included: total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides test by any accepted method; bilirubin, blood, glucose, ketone, leukocyte, nitrate, potential of hydrogen (pH), protein, specific gravity, and urobilinogen tests by nonautomated or automated urinalysis by dipstick; fecal occult blood by any accepted method; ovulation test by visual color comparison; qualitative urine pregnancy test by visual color comparison; erythrocyte sedimentation rate by any accepted nonautomated method; whole blood glucose by any accepted single analyte method; spun microhematocrit by any accepted method; hemoglobin by single analyte instrument or manual copper sulfate method; helicobacter pylori, influenza, mononucleosis, streptococcus group A, hepatitis C virus, and respiratory syncytial virus by immunoassay using a rapid test device that detects antibodies or antigens; prothrombin time international normalized ratio by mechanical endpoint; antibodies to HIV types 1 and 2; nicotine or cotinine test by urine; thyroid stimulating hormone test by blood; bone mass and bone mineral density test by any accepted method; and drug screening tests by urine.

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes. 
  • Pharmacy Medical Billing Manual 05.01.2023.pdf (nd.gov)
    • Does the law/regulation apply to specific services?
      • Pharmacists are reimbursable for tobacco cessation counseling, immunizations, and MTM services.
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Neb. Rev. Stat. Ann. § 38-2806
• Neb. Rev. Stat. Ann. § 38-2837
• Definition of scope of practice includes administration
• Administration explicitly includes drug administration by injection

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• Neb. Rev. Stat. Ann. § 38-2867.03
• Does CPA need to be patient-specific?
  • No, CPA is not required to be patient-specific.
• Are there filing requirements?
  • Yes, pharmacist must notify Board of Pharmacy of CPA (need not submit copy) and any subsequent amendments to CPA. Notice must identify the primary care provider with whom pharmacist is entering into CPA and provide a description of the therapy being monitored or initiated.
  • A copy of CPA must be made available to the Board of Pharmacy upon request.
• Are there content requirements?
  • Yes, CPA must be in writing and signed by both the pharmacist and the primary care provider. CPA is effective once both parties have signed.
  • CPA should identify the drug therapy being monitored or initiated.
• Is there a time period limit?
  • Yes, CPA must be renewed every two years.
• Is the pharmacist required to undergo additional training?
  • No, pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• N.H. Rev. Stat. Ann. § 318:1
• Definition of scope of practice includes administration
• Broad definition of administration that includes provision of drug pursuant to a prescription order interpreted to include injectable prescription drug

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• N.H. Rev. Stat. Ann. § 318:16-a
• N.H. Code Admin. R. Ph 1103.01 
• N.H. Code Admin. R. Ph 1104.01
• N.H. Code Admin. R. Ph 1105.01—.03
• Does CPA need to be patient-specific?
  • Yes, the CPA must be patient specific.
  • Pharmacist must obtain the written consent of the patient to provide services under CPA. Such a statement must include explicit consent for the pharmacist to provide services outlined in CPA.
• Are there filing requirements?
  • Yes, pharmacist must submit a copy of CPA and proof of professional liability insurance to the Board of Pharmacy.
  • Any subsequent changes made to CPA must be submitted to the Board of Pharmacy within 15 days of such changings going into effect.
  • Pharmacist and primary care practitioner must each keep a copy of CPA on file, which Board of Pharmacy can request a copy of at any time.
• Are there content requirements?
  • Yes, CPA must describe the types of decisions concerning the management of drug therapy that the pharmacist is authorized to make, which may include a specific description of the diseases and drugs for which the pharmacist is authorized to manage drug therapy.
  • CPA must list the laboratory tests that the pharmacist may order to manage a medication therapy.
  • CPA must include a statement of the expected amount of dedicated time that a pharmacist will use exclusively to perform duties in the CPA.
  • CPA must list beginning and ending dates agreement will be in effect.
  • CPA must state the conditions and events for which the pharmacist must notify the primary care provider.
  • CPA must include a statement that the agreement may be terminated in writing by either party at any time.
  • Pharmacist must have at least $1,000,000 of professional liability insurance coverage.
• Is there a time period limit?
  • Yes, the CPA must be renewed every two years.
• Is the pharmacist required to undergo additional training?
  • It depends. Pharmacist may have to undergo additional training if the Board of Pharmacy determines such training is necessary for the pharmacist to adequately provide the services outlined in the CPA.
  • If the CPA delegates authority to administer vaccines, pharmacist is required to hold current basic or higher certification in cardiopulmonary resuscitation (CPR) from the American Heart Association, the American Red Cross, or from another organization or entity that is nationally recognized as an issuer of such certifications.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Pharmacist may only administer injectable PrEP if under the authority of a CPA with a primary care provider

• N.J. Stat. Ann. § 45:14-41

CPA: Regulation permits pharmacist to enter into a CPA with a primary care provider

• N.J. Admin. Code § 13:39-13.3—.5
• Does CPA need to be patient-specific?
  • No, the CPA is not required to be patient-specific.
• Are there filing requirements?
  • Yes, the pharmacist must receive approval from the Board of Pharmacy to engage in a CPA. To receive approval, the pharmacist must submit proof that one of the following have been completed: 1) an ACPE-approved training program, 2) post-graduate residency program accredited by the American Society of Health-System Pharmacists; or 3) a certification program from the Board of Pharmacy Specialties.
  • A written copy of the CPA (and any changes made to CPA) must be made available to the CPA upon request.
• Are there content requirements?
  • Yes, CPA must identify the following: 1) collaborating pharmacist; 2) collaborating primary care provider; 3) date of the agreement; and 4) description of scope of services covered under agreement.
  • Regarding the scope of services, the agreement must explicitly specify the decisions the pharmacist is authorized to make. This includes the types of diseases, drugs, or drug categories involved and the type of collaborative authority. The agreement must state the procedures, decision criteria, or plans the pharmacists are to follow when making therapeutic decisions, particularly when modification or initiation of drug therapy is involved.
  • CPA must be signed by pharmacist and primary care provider.
  • CPA must state effective date of agreement.
  • CPA must include a statement that the agreement may be terminated in writing by either party at any time.
• Is there a time period limit?
  • Yes, the CPA must be reviewed at least once per year by the parties to determine whether the protocol should be renewed, modified, or terminated.
• Is the pharmacist required to undergo additional training?
  • Yes, the pharmacist must complete a minimum of 10 credits of continuing education every biennial renewal period in each disease(s) or condition(s) covered by the CPA.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No. N.J. Stat. Ann. 45:14-41
  • Statute does not mention federal CLIA, but states that pharmacists may only order clinical laboratory tests “based on the standing orders of a physician as set forth in the written protocol, provided those laboratory tests are granted waived status in accordance with the provisions of the “New Jersey Clinical Laboratory Improvement Act,” P.L.1975, c. 166 (C.45:9-42.26 et seq.)”
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • No

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP:  Statewide protocols gives pharmacists the authority to independently initiate PrEP and PEP (PEP: effective since 5/31/21; PrEP: Passed 4/4/23, Effect date: 7/1/23)

• S.B. 92 (N.M. 2023).
• N.M. Stat. Ann. § 61-11-2
• N.M. Admin. Code 16.19.26.14
• https://www.rld.nm.gov/wp-content/uploads/2021/07/PEP-Prescriptive-Authority-Training-outline-UNM-AETC-BOP.pdf
• https://www.rld.nm.gov/uploads/files/PEPProtocolALONE.pdf
• Does the pharmacist need a standing order from a primary care provider?
  • No, the pharmacist does not need a standing order from a primary care provider.
  • Pharmacists are required to inform a patient’s primary health care provider of any services related to the initiation and dispensing of PrEP or PEP. Pharmacists must first obtain informed consent from the patient to do so.
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • No, legislation does not address pharmacist’s reimbursement or other insurance provisions.
• Is there a quantity limit for prescriptions?
  • No, New Mexico law does not impose quantity limits on pharmacy-initiated PrEP nor limit the frequency with which pharmacists can prescribe PrEP or PEP to a given patient.
• Does the pharmacist have to undergo additional training?
  • Yes, the pharmacist must undergo additional training.
  • To prescribe PEP, pharmacist must follow the instructions of the Board of Pharmacy’s protocol. This protocol requires pharmacists to complete two hours of ACPE-approved continuing education regarding HIV PEP every two years.
  • To prescribe PrEP, SB 92 requires pharmacists to follow the instructions of a statewide protocol developed by the Board of Pharmacy. However, the Board of Pharmacy has yet to establish a protocol regarding pharmacists seeking to prescribe PrEP. Pharmacists in New Mexico must wait until such a statewide protocol is released until they may prescribe PrEP.

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• N.M. Stat. Ann. § 61-11-2
• Definition of scope of practice includes administration
• Administration explicitly includes drug administration by injection

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• N.M. Stat. Ann. § 61-11B-3
• N.M. Admin. Code 16.19.4.7
• N.M. Admin. Code 16.19.4.17
• Does CPA need to be patient-specific?
  • No, CPA is not required to be patient-specific.
• Are there filing requirements?
  • Yes, pharmacist must submit a copy of the CPA to the Board of Pharmacy to keep on file.
• Are there content requirements?
  • Yes, CPA must identify the following: 1) collaborating pharmacist; 2) collaborating primary care provider; and 3) description of scope of services covered under agreement.
  • Regarding the scope of services, the agreement must explicitly specify the decisions the pharmacist is authorized to make. This includes the types of diseases, drugs, or drug categories involved and the type of collaborative authority. The agreement must state the procedures, decision criteria, or plans the pharmacists are to follow when making therapeutic decisions, particularly when modification or initiation of drug therapy is involved.
  • Granting authority to pharmacist to provide services outside of the primary care practitioner’s scope of practice is explicitly prohibited.
  • CPA must establish a means for the primary care provider and pharmacist to communicate.
  • CPA must identify what laboratory tests (if any) pharmacist is authorized to order.
• Is there a time period limit?
  • Yes, CPA must be renewed every two years.
• Is the pharmacist required to undergo additional training?
  • Yes, pharmacist must apply for certification to enter into a CPA. To receive certification, the pharmacist must submit each of the following to the Board of Pharmacy: 1) proof of completion of a 60-hour, board-approved physical assessment course, followed by a 150-hour, 300-patient contact preceptorship supervised by a physician or other practitioner with prescriptive authority, with hours counted only during direct patient interactions and 2) a log of patient encounters initiated and completed within two years of the application. 
  • If the pharmacist is seeking to prescribe controlled substances through a CPA, then proof of completing a training course on responsible opioid prescribing practices must also be submitted to the Board of Pharmacy.
  • Pharmacists must be re-approved every other year. Recertification requires the following documentation to be sent to the Board of Pharmacy: 1) proof of continuing education hours, including proof of completion of 2.0 CEU 20 contact hours of live CPE or continuing medical education (CME) approved by (ACPE) or ACCME; 2) a copy of the CPA signed by the collaborating primary care practitioner; and 3) a copy of initial CPA certification. If CPA delegates pharmacist authority to prescribe controlled substances, pharmacist must also submit proof of completing a minimum of 0.2 CEU (two contact hours) per renewal period in the subject area of responsible opioid prescribing practices.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived test
  • Yes. N.M. Stat. Ann. § 61-11-2.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • Yes, pharmacists are limited to performing CLIA-waived tests for the following conditions: 1) influenza; 2) group A streptococcus pharyngitis; 3) COVID-19; and 4) HIV (limited to the provision of PrEP and PEP).

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes. 
  • SUPPLEMENT-22-03-PHARMACEUTICAL-SERVICE-REIMBURSEMENT-PARITY-FINAL.pdf (state.nm.us)
    • Does the law/regulation apply to specific services?
      • New Mexico law allows pharmacists to be certified to prescribe in areas such as hormonal contraception, tobacco cessation, immunizations, Naloxone drug therapy, tuberculosis testing (serum prescribing, administration and follow up reading are included as a single submission), and HIV Post-Exposure Prophylaxis (PEP) therapy, in accordance with the written protocols approved by the NMBOP.
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • Reimbursement shall be paid to the Pharmacist Clinician or entity at the same rate that is paid to a licensed physician, physician assistant (PA), or advanced nurse practitioner (NP) for the same service.
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Statewide protocol gives pharmacists the authority to independently initiate PrEP and PEP (Enacted 10/1/21)

• S.B. 325 (Nev. 2021).
• NV Statewide Protocol
• Nev. Rev. Stat. Ann. § 639.0124
• Nev. Rev. Stat. Ann. § 639.28085 
• Nev. Rev. Stat. Ann. § 689B.0312 
• Nev. Admin. Code R039-21
• Does the pharmacist need a standing order from a primary care provider?
  • No, the pharmacist does not need a standing order from a primary care provider.
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • Yes, Nevada law requires health insurers, Medicaid, and state employee plans to provide coverage and reimbursement for PrEP and PEP related services at a rate equal to the rate of reimbursement provided to a physician, physician assistant or advanced practice registered nurse for similar services.
  • State Medicaid is required to cover any laboratory tests ordered in connection with pharmacists prescribing PrEP and PEP.
• Is there a quantity limit for prescriptions?
  • No, Nevada law does not impose quantity limits on pharmacy-initiated PrEP nor limit the frequency with which pharmacists can prescribe PrEP or PEP to a given patient.
• Does the pharmacist have to undergo additional training?
  • Yes, pharmacists prescribing and dispensing PrEP and PEP must complete a two-hour course approved by the ACPE regarding treatment for PrEP and PEP for HIV-negative persons.
  • Pharmacists must have professional liability insurance coverage of at least $1,000,000.

INJECTABLE PrEP/CABROTEGRAVIR: Limited authority to administer injectable PrEP

• Nev. Rev. Stat. Ann. § 639.0124 
• Nev. Rev. Stat. Ann. § 639.28085 
• Nev. Admin. Code R039-21 3
• Pharmacist has explicit authority to prescribe, dispense, and administer any drug approved by the FDA to prevent HIV
• Before a pharmacist may do so, however, the following requirements must be met: 1) complete an ACPE-approved course of training concerning the prescribing, dispensing and administering of such drugs; 2) maintain and make readily available proof of completion of said course; and 3) maintain professional liability insurance coverage of at least $1,000,000.

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• Nev. Rev. Stat. Ann. § 639.2623
• Nev. Rev. Stat. Ann. § 639.2627
• Does CPA need to be patient-specific?
  • Yes, the CPA must be patient specific.
  • Pharmacist must obtain the written consent of the patient to provide services under CPA. Such a statement must include explicit consent for the pharmacist to initiate, modify, or discontinue the medication of the patient pursuant to the CPA.
  • Patient must receive notification from the pharmacist of the following: 1) any test administered by the pharmacist and the results of such a test; 2) the name of any drug or prescription filled and dispensed by the pharmacist to the patient; and 3) the contact information of the pharmacist.
• Are there filing requirements?
  • Yes, a written copy of the CPA must be submitted to the Board of Pharmacy.
• Are there content requirements?
  • Yes, CPA must describe the types of decisions concerning the management of drug therapy that the pharmacist is authorized to make, which may include a specific description of the diseases and drugs for which the pharmacist is authorized to manage drug therapy.
  • Pharmacist must be required to document any services provided to the patient pursuant to the CPA in said patient’s medical file.
  • Granting authority to pharmacist to provide services outside of the primary care practitioner’s scope of practice is explicitly prohibited.
  • CPA must include a clause granting primary care practitioner the authority to override the agreement if necessary to protect the health of the patient or accomplish the goals of the treatment prescribed for the patient.
  • CPA must establish a means for the primary care provider and pharmacist to communicate and document changes to the patient's medical record.
  • CPA must state the conditions and events for which the pharmacist must notify the primary care provider.
  • CPA must be in writing and signed by pharmacist and primary care practitioner.
• Is there a time period limit?
  • Yes, CPA must be renewed (at the latest) one year after the date on which the agreement becomes effective.
• Is the pharmacist required to undergo additional training?
  • No, pharmacist is not required to undergo additional training.
  • CPA may require pharmacist to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes, the statewide protocol authorizing pharmacists to initiate PrEP and PEP specifically authorizes pharmacists to conduct HIV-related tests. NV Statewide Protocol
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • Yes, pharmacists are limited to HIV-related tests.

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes 
  • Pharmacists can bill Medicaid (nv.gov)
  • In 2021, SB190 and SB325 passed allowing pharmacists to provide and be reimbursed for services related to self-administered hormonal contraceptives and the prevention acquisition of HIV. In 2022, CMS approved Nevada Medicaid’s SPA to include pharmacists as a new provider type. Since then, Nevada Medicaid has implemented a new provider type: PT 91 – Pharmacist and established Medicaid policy surrounding pharmacist-provided services.
    • Does the law/regulation apply to specific services?
      • Pharmacists are reimbursed for more than 40 codes including the following services without a prescription: ordering certain HIV laboratory testing; the dispensing of self-administered hormonal contraceptives; the prescribing, dispensing and administration of drugs to prevent the acquisition of HIV.
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Pharmacists may prescribe and dispense PEP (not PrEP) pursuant to a non-patient specific standing order (Effective since 2017)

• S.B. 129 (N.Y. 2017).
• N.Y. Comp. Codes R. & Regs. tit. 8, § 63.13
• Does the pharmacist need a standing order from a primary care provider?
  • Yes, the pharmacist needs a non-patient specific standing order from a primary care practitioner.
  • Nurse practitioners qualify as primary care practitioners.
  • To participate as a licensed practitioner under a non-patient specific standing order, the licensed physician or nurse practitioner must be available to provide follow-up appointments for patients who initiated PEP in the pharmacy, establish agreements with other healthcare providers to accept referrals of patients within one to three days, and respond to calls from pharmacists in cases where a patient has a negative reaction to a PEP regimen.
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • No, the legislation does not address pharmacist’s reimbursement or other insurance provisions.
• Is there a quantity limit for prescriptions?
  • Yes, pharmacists are limited to prescribing seven days of PEP.
• Does the pharmacist have to undergo additional training?
  • No, the pharmacist does not have to undergo additional training.

INJECTABLE PrEP/CABROTEGRAVIR: Administration of injectable PrEP is prohibited

• N.Y. Educ. Law § 6802
• Administration is explicitly limited to only certain listed prescription drug types. Injectable PrEP does not fall into one of these types of injectable drugs, and pharmacists are, therefore, prohibited from administration. 

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• N.Y. Educ. Law § 6801-a 
• N.Y. Comp. Codes R. & Regs. tit. 8, § 63.10
• Does CPA need to be patient-specific?
  • No, the CPA need not be patient specific. However, a patient must consent in writing prior to receiving a pharmacist’s services under a CPA.
• Are there filing requirements?
  • No, there are not filing requirements.
• Are there content requirements?
  • Yes, CPA must describe the types of decisions concerning the management of drug therapy that the pharmacist is authorized to make, which may include a specific description of the diseases and drugs for which the pharmacist is authorized to manage drug therapy.
  • CPA must establish a means for the primary care provider and pharmacist to communicate.
  • Pharmacist must be required to document any services provided to the patient pursuant to the CPA in said patient’s medical file.
  • CPA must state the conditions and events for which the pharmacist must notify the primary care provider.
  • CPA is prohibited from authorizing pharmacist ability to diagnose a disease.
  • CPA should contain a clause stating that, in the event that a treating physician may disagree with the exercise of professional judgment by a pharmacist, the judgment of the treating physician shall prevail.
• Is there a time period limit?
  • No, there is not a time period limit.
• Is the pharmacist required to undergo additional training?
  • It depends. A pharmacist must have a certain number of years’ experience in the practice of pharmacy based on the pharmacist’s level of education. If the pharmacist has either a master or doctorate in pharmacy, the pharmacist must (within the last 3 years) have two years’ experience, of which at least one year of such experience shall include clinical experience in a health facility, which involves consultation with physicians with respect to drug therapy and may include a residency at a facility involving such consultation. If the pharmacist has a bachelor’s in pharmacy, the pharmacist must (within the last 7 years) have three years’ experience, of which at least one year of such experience shall include clinical experience in a health facility, which involves consultation with physicians with respect to drug therapy and may include a residency at a facility involving such consultation. (A year of experience shall mean not less than 1,680 hours of work, which includes an average of 15 hours of clinical experience a week, as a pharmacist within a period of one calendar year.)

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Pharmacist may only administer injectable PrEP if under the authority of a CPA with a primary care provider

• Ohio Rev. Code Ann. § 4729.01

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• Ohio Rev. Code Ann. § 4729.01
• Ohio Rev. Code Ann. § 4729.39
• Ohio Admin. Code 4729:1-6-01 – 03
• Does CPA need to be patient-specific?
  • No, CPA does not need to be patient-specific.
  • A primary care provider must have an established provider-patient relationship with a patient before a pharmacist may provide services to that patient under a CPA.
• Are there filing requirements?
  • No, there are not filing requirements.
  • A written copy of the CPA must be made available to the Board of Pharmacy upon request.
• Are there content requirements?
  • Yes, CPA must identify the following: 1) collaborating pharmacist; 2) collaborating primary care provider; 3) effective date and expiration date of the agreement; and 4) description of scope of services covered under agreement.
  • Regarding the scope of services, the agreement must explicitly specify the decisions the pharmacist is authorized to make. This includes the types of diseases, drugs, or drug categories involved and the type of collaborative authority. The agreement must state the procedures, decision criteria, or plans the pharmacists are to follow when making therapeutic decisions, particularly when modification or initiation of drug therapy is involved.
  • Granting authority to pharmacist to provide services outside of the primary care practitioner’s scope of practice is explicitly prohibited.
  • CPA must establish a means for the primary care provider and pharmacist to communicate. Said communication must occur at specified regular intervals.
  • CPA must identify what laboratory tests (if any) pharmacist is authorized to order.
  • The existence of the CPA must be relayed to any patient receiving services pursuant to the agreement.
  • Pharmacist and primary care practitioner must sign CPA and any subsequent amendments added to the original CPA.
  • CPA must contain a clause stating that the agreement may be terminated by either the 1) collaborating physician, 2) collaborating pharmacist, or 3) the patient receiving services pursuant to the agreement.
• Is there a time period limit?
  • Yes, the CPA must be renewed every two years.
• Is the pharmacist required to undergo additional training?
  • It depends. Pharmacist must have training and experience related to the diagnosis for which drug therapy is to be prescribed.
  • CPA may require pharmacist to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes. Ohio. Admin. Code 4729:1-3-01
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • There are no limitations on which tests may be performed, but the pharmacist may only perform CLIA-waived tests if the following conditions are met:
    • (1) The pharmacy or facility is certified by HHS as a clinical laboratory through the CLIA;
    • (2) The pharmacy or facility has obtained a CLIA certificate of waiver from HHS; and
    • (3) The responsible person of the terminal distributor of dangerous drugs and the terminal distributor of dangerous drugs ensures and documents that all pharmacists conducting CLIA-waived tests pursuant to this rule receive appropriate training to conduct testing in a safe and effective manner.

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes – ongoing effort in the state
  • OPA | Provider Status (ohiopharmacists.org)
  • In 2019, Governor John Kasich signed SB 265, which formally recognized pharmacists as providers in Ohio. SB 265 changed key provider definitions and insurance laws to catch up to the growing role of the pharmacist and removed barriers that prevented health plans, hospitals and healthcare teams from integrating and utilizing the expertise of the pharmacist.
  • As of 2020, pharmacists enrolled with UHC Medicaid will be reimbursed for the time spent managing chronic conditions, conducting transitions of care visits, and interprofessional consults with other healthcare providers.
    • Does the law/regulation apply to specific services?
      • Broad expansion of pharmacists’ role statewide.
      • UHC specified which services are reimbursable: adherence checks, medication reconciliations, new medication counseling, disease state management, and transitions of care management.
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • No

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Okla. Stat. Ann. tit. 59, § 353.1
• Definition of scope of practice includes administration
• Administration explicitly includes drug administration by injection

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• Okla. Stat. Ann. tit. 59, § 353.30 
• Okla. Admin. Code 535:10-9-5
• Does CPA need to be patient-specific?
  • No, the CPA does not need to be patient-specific.
• Are there filing requirements?
  • No, there are not filing requirements.
  • Pharmacist must keep a written copy of CPA on file, which must be made available to the Board of Pharmacy upon request.
• Are there content requirements?
  • No, there are not content requirements.
• Is there a time period limit?
  • No, there is not a time period limit.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP:  Statewide standing order gives immunizing pharmacists the authority to independently initiate PrEP and statute gives pharmacists the authority to initiate both PrEP and PEP (Statute effective since 9/25/21; Statewide Protocol effective since June 2023)

• H.B. 2958 (Or. 2021).
• Or. Rev. Stat. Ann. § 689.005 
• Or. Rev. Stat. Ann. § 689.704
• Or. Rev. Stat. Ann. § 743A.051
• Or. Rev. Stat. Ann. § 743B.425 
• Or. Rev. Stat. Ann. § 743B.602
• Oregon PrEP Statewide Protocol
• Does the pharmacist need a standing order from a primary care provider?
  • No, pharmacists do not need a standing order from a primary care provider.
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • Yes, health insurers covering services within a pharmacist’s scope of practice must provide reimbursement at a rate equal to the rate that the services are reimbursed when provided by a physician.
  • Health insurers are prohibited from requiring prior authorization before a pharmacist dispenses PrEP and PEP.
• Is there a quantity limit for prescriptions?
  • Yes, pharmacists are limited to prescribing up to a 90-day supply of PrEP and a complete course of PEP.
• Does the pharmacist have to undergo additional training?
  • No, the pharmacist does not have to undergo additional training.

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Or. Rev. Stat. Ann. § 689.005
• Or. Rev. Stat. Ann. § 689.655
• Definition of scope of practice includes administration
• Administration explicitly includes drug administration by injection

CPA: Regulation permits pharmacist to enter into a CPA with a primary care provider

• Or. Rev. Stat. Ann. § 689.655
• Or. Admin. R. 847-015-0040
• Or. Admin. R. 855-006-0005(10)
• Or. Admin. R. 855-115-0320
• Does CPA need to be patient-specific?
  • Yes, CPA must be patient-specific.
• Are there filing requirements?
  • No, there are not filing requirements.
• Are there content requirements?
  • Yes, CPA must identify the following: 1) collaborating pharmacist; 2) collaborating primary care provider; 3) effective date and expiration date of the agreement; and 4) description of scope of services covered under agreement.
  • Regarding the scope of services, the agreement must explicitly specify the decisions the pharmacist is authorized to make. This includes the types of diseases, drugs, or drug categories involved and the type of collaborative authority. The agreement must state the procedures, decision criteria, or plans the pharmacists are to follow when making therapeutic decisions, particularly when modification or initiation of drug therapy is involved.
  • CPA must state the conditions and events for which the pharmacist must notify the primary care provider.
  • Pharmacist must document any services provided pursuant to CPA.
• Is there a time period limit?
  • No, there a time period limit.
• Is the pharmacist required to undergo additional training?
  • No, pharmacist is not required to undergo additional training.
  • CPA may require pharmacist to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes. O.R.S. § 689.661
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • No

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes. 
  • Pharmacist fee-for-service community pharmacist professional billing.pdf (oregon.gov)
    • Does the law/regulation apply to specific services?
      • Pharmacists are reimbursed for prescribing hormonal contraception, prescribing smoking cessation products, initiating vaccination, administering immunizations, providing MTM, and preventive medicine counseling.
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Limited authority to administer injectable PrEP

• 63 Pa. Stat. Ann. § 390-9.2 
• Before a pharmacist may do so, however, the following requirements must be met: 1) complete an ACPE-approved course of training concerning the prescribing, dispensing and administering of such drugs; 2) maintain and make readily available proof of completion of said course; and 3) maintain professional liability insurance coverage of at least $1,000,000.
• Pharmacist must notify the individual's primary care provider, if known, within forty-eight hours of administration.
• A minimum of two hours of the thirty-hour requirement for continuing education for license renewal be dedicated to injectable medications.

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• 49 Pa. Code § 27.302
• 63 Pa. Stat. Ann. §390-2(14)
• 63 Pa. Stat. Ann. § 390-9.1
• 63 Pa. Stat. Ann. 390-9.3 
• Does CPA need to be patient-specific?
  • No, the CPA does not need to be patient specific.
  • However, a pharmacist may only manage a patient’s drug therapy pursuant to a CPA if said patient’s drug therapy management was initiated by the collaborating primary care practitioner.
  • Each patient receiving services pursuant to a CPA must be notified of the agreement’s existence and be provided the opportunity to refuse management of drug therapy by the collaborating pharmacist.
• Are there filing requirements?
  • Yes, the CPA must be filed with the state’s Bureau of Professional and Occupational Affairs, the Board of Pharmacy, and the Board of Medicine.
  • Pharmacist and primary care practitioner must each keep a written copy of CPA on file, which must be made available to patients, the Bureau of Professional and Occupational Affairs, and the Department of Health upon request.
• Are there content requirements?
  • Yes, CPA must identify the following: 1) collaborating pharmacist; 2) collaborating primary care provider; 3) dated signatures of collaborating primary care practitioner and pharmacist; and 4) description of scope of services covered under agreement.
  • Regarding the scope of services, the agreement must explicitly specify the decisions the pharmacist is authorized to make. This includes the types of diseases, drugs, or drug categories involved and the type of collaborative authority. The agreement must state the procedures, decision criteria, or plans the pharmacists are to follow when making therapeutic decisions, particularly when modification of drug therapy is involved. The agreement must also specify what (if any) lab and/or diagnostic tests the pharmacist is authorized to order.
  • CPA must state that the pharmacist must notify the primary care practitioner within 72 hours of changes in dose, duration, or frequency of medication prescribed.
  • As drug therapy management must be initiated by primary care practitioner, CPA may not provide pharmacist prescriptive authority.
  • Pharmacist must document any services provided pursuant to CPA.
  • CPA must contain a clause permitting pharmacist and primary care practitioner to terminate the agreement at any time.
  • Pharmacist and primary care practitioner must explicitly have access to all medical records of patients provided services pursuant to the CPA.
• Is there a time period limit?
  • Yes, the CPA must be renewed every two years.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.
  • Pharmacist must have at least $1,000,000 professional liability insurance coverage.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes. 63 P.S. § 390-9.5
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • Limited to COVID-19, influenza and streptococcal infections

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes. Pharmacists enrolled in Pennsylvania Medical Assistance Program may be granted provider status under PA Medicaid. OFFICIAL MEDICAL ASSISTANCE BULLETIN.
    • Does the law/regulation apply to specific services?
      • No.
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • Yes. Every health care service plan that offers coverage for a service that is within a pharmacist’s scope of practice must reimburse the pharmacist at a rate equal to what the insurer would reimburse a primary care provider for the same service.
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Pharmacists may prescribe and dispense PrEP and PEP pursuant to a pursuant to a pursuant to a non-patient specific standing order (Passed June 2023)

• S.B. 0575
• 27 R.I. Gen. Laws Ann. § 27-18-91, 93
• 27 R.I. Gen. Laws Ann. § 27-19-83, 85
• 27 R.I. Gen. Laws Ann. § 27-20-79, 81
• 27 R.I. Gen. Laws Ann. § 27-41-96, 98
• Does the pharmacist need a standing order from a primary care provider?
  • Yes, the pharmacist needs a non-patient specific standing order from a primary care practitioner.
  • Pharmacists are required to inform a patient’s primary care provider if the pharmacist prescribes PrEP or PEP. If the patient does not have a primary care provider, then the pharmacist must provide a list of local primary care providers.
  • [The law enables the Rhode Island Board Pharmacy to establish a statewide protocol that would enable pharmacists in the state to independently furnish PrEP and PEP. However, the State Board of Pharmacy has yet to do so.]
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • Yes, all health insurance plans issued or renewed after 1/1/24 are required to cover both PrEP and PEP.
  • All health insurance plans must also provide access to at least one version of both PrEP and PEP without any prior authorization or step therapy requirements. Additionally, all health insurance plans are prohibited from imposing a copayment or deductible to be met.
• Is there a quantity limit for prescriptions?
  • Yes, pharmacists are limited to prescribing up to a 60-day supply (with a requirement of prescribing at least a 30-day supply) of PrEP no more than twice in a two year period for each given patient or one complete 28-day course of PEP.
• Does the pharmacist have to undergo additional training?
  • Yes, a pharmacist must first complete a training program approved by the Rhode Island Board of Pharmacy that addresses the following: 1) the use of protocols developed by the board for prescribing, dispensing, and administering an HIV prevention drug; 2) the requirements for any laboratory testing for HIV; and 3) on guidelines for prescription adherence and best practices to counsel patients prescribed an HIV prevention drug.

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• 216 R.I. Code R. 40-15-1.2
• Definition of scope of practice includes administration
• Administration explicitly includes drug administration by injection

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• 5 R.I. Gen. Laws Ann. § 5-19.2-2, 3
• R.I. Code R. 40-15-1.13
• Does CPA need to be patient-specific?
  • No, CPA does not need to be patient-specific.
• Are there filing requirements?
  • No, there are not filing requirements.
• Are there content requirements?
  • Yes, CPA must be in writing and signed by collaborating pharmacist and primary care practitioner.
  • CPA must identify the following: 1) the site and setting where the collaborative practice is to take place; 2) informed consent procedures; (3) qualifications of participating pharmacist and primary care practitioner; 4) the role of any employed healthcare professional with prescriptive privileges participating in the collaborative practice; 5) scope of conditions or diseases to be managed; 6) practice protocols; 7) risk management activities; and 8) outcome measurements. 
• Is there a time period limit?
  • Yes, CPA must be renewed every other year following the agreement’s effective date.
• Is the pharmacist required to undergo additional training?
  • It depends. A pharmacist must be licensed to practice in the state of Rhode Island and have a Bachelor of Science in pharmacy and postgraduate educational degree or a Doctor of Pharmacy degree. Pharmacist must also have experience relevant to the scope of services outlined in CPA.
  • CPA may require pharmacist to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes. 5 R.I. Gen. Laws. Ann. § 5-19.1-2.
  • CLIA-waived tests are referred to as “limited-function tests” in this section.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • Yes, includes only the following: blood glucose, hemoglobin A1c, cholesterol tests, and/or other tests that are classified as waived under CLIA and are approved by the United States Food and Drug Administration for sale to the public without a prescription in the form of an over-the-counter test kit. This definition would include rapid HIV tests.

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• S.C. Code Ann. § 40-43-30
• Definition of scope of practice includes administration
• Administration explicitly includes drug administration by injection

CPA: N/A

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Limited authority to administer injectable PrEP

• S.D. Codified Laws § 36-11-2.2
• S.D. Admin. R. 20:51:31:15
• Pharmacist required to undergo additional training to administer

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• S.D. Codified Laws § 36-11-19.1(6)
• Does CPA need to be patient-specific?
  • No, CPA does not need to be patient-specific.
• Are there filing requirements?
  • No, there are not filing requirements.
• Are there content requirements?
  • No, there are not content requirements.
• Is there a time period limit?
  • No, there is not a time period limit.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

S.D. Codified Laws § 36-11-2.2: “The practice of pharmacy does not authorize a pharmacist to prescribe drugs as a practitioner or to dispense drugs without a prescription drug order.” (emphasis added)

ORAL PrEP: Statute gives pharmacists the authority to independently initiate PEP (Passed 5/9/24)

• S.B. 869, (Tenn. 2024)
• Tenn. Code Ann. § 63-10-204 
• Does the pharmacist need a standing order from a primary care provider?
  • No, the pharmacist does not need a standing order from a primary care provider.
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • No, legislation does not address pharmacist’s reimbursement or other insurance provisions.
• Is there a quantity limit for prescriptions?
  • No, Tennessee’s law does not impose quantity limits on pharmacy-initiated PEP nor limit the frequency with which pharmacists can prescribe PEP to a given patient.
• Does the pharmacist have to undergo additional training?
  • No, the pharmacist does not have to undergo additional training.

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Tenn. Code Ann. § 63-10-204
• Definition of scope of practice includes administration
• Administration explicitly includes drug administration by injection

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• Tenn. Code Ann. § 63-10-204(5)
• Tenn. Code Ann. § 63-10-217 
• Tenn. Comp. R. & Regs. 1140-15-.04
• Tenn. Comp. R. & Regs. 1140-03-.17
• Does CPA need to be patient-specific?
  • No, the CPA does not need to be patient-specific.
  • However, a patient receiving services under a CPA must have signed a general consent that the patient is to receive services from a healthcare team, including a pharmacist.
• Are there filing requirements?
  • Yes, the pharmacist must notify the Board of Pharmacy of the existence of the CPA within 30 days following the agreement’s effective date. Notice must identify the following: 1) the collaborating pharmacist; 2) the collaborating primary care provider; 3) the effective date of the CPA; and 4) the scope of services covered by the agreement.
  • Pharmacist and primary care provider must each keep a written copy of CPA on file.
• Are there content requirements?
  • Yes, CPA must be in writing and signed by collaborating pharmacist and primary care practitioner.
  • Pharmacist must document within 72 hours of administration any services provided pursuant to CPA in a patient record, to which the primary care provider has access.
  • CPA must identify the scope of services pharmacist may provide under the agreement.
  • Regarding the scope of services, the agreement must explicitly specify the decisions the pharmacist is authorized to make. This includes the types of diseases, drugs, or drug categories involved and the type of collaborative authority. The agreement must state the procedures, decision criteria, or plans the pharmacists are to follow when making therapeutic decisions, particularly when modification or initiation of drug therapy is involved.
  • Granting authority to pharmacist to provide services outside of the primary care practitioner’s scope of practice is explicitly prohibited.
  • CPA must include a clause granting primary care practitioner the authority to override the agreement if necessary to protect the health of the patient or accomplish the goals of the treatment prescribed for the patient.
  • All care and services provided by the pharmacist pursuant to the CPA, except immunizations, opioid antagonists, and preventative care, must be pursuant to a diagnosis made and documented by the collaborating primary care provider.
  • CPA must include a section with written measurable and objective performance goals for evaluating the quality of care provided for the patients treated pursuant to the CPA. These goals and patient data must be reviewed by the pharmacist and primary care provider at least quarterly.
  • CPA is explicitly prohibited from delegating the authority to prescribe controlled substances to the pharmacist.
• Is there a time period limit?
  • Yes, CPA must be renewed every 2 years.
• Is the pharmacist required to undergo additional training?
  • It depends. A pharmacist must be licensed to practice in the state of Rhode Island and have a bachelor of science in pharmacy and been active on the practice of pharmacy (“active” time period not specified) or a doctor of pharmacy degree.
  • Pharmacist must have at least $1,000,000 professional liability insurance coverage.
  • Pharmacists engaged in the collaborative pharmacy practice are strongly encouraged (but not required) to complete ten hours of the biennially required thirty hours of continuing education in topics related to the clinical practice of pharmacy.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No. T. C. A. § 63-10-204(39)(B).
  • [However, a pharmacist may order an HIV laboratory test in conjunction with dispensing PEP to a patient. Code Ann. § 63-10-204]
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes, see Medication Therapy Management Program (tn.gov)
    • TN has a MTM program that allows pharmacists to provide various clinical services. The program authorizes qualified Tennessee-licensed pharmacists to provide MTM services to eligible TennCare members under a CPA with TennCare Patient Centered Medical Homes (PCMH) and Health Link.
    • Does the law/regulation apply to specific services?
      • “MTM services include medication reviews, pharmacotherapy consult, anticoagulation management, immunizations, health and wellness programs and many other clinical services.”
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Pharmacist may only administer injectable PrEP if under the authority of a CPA with a primary care provider

• Tex. Occ. Code Ann. § 551.003 
• Tex. Occ. Code Ann. § 563.051 

CPA: Regulation permits pharmacist to enter into a CPA with a primary care provider

• Tex. Occ. Code Ann. § 554.005
• 22 Tex. Admin. Code § 295.13
• Does CPA need to be patient-specific?
  • No, the CPA does not need to be patient specific.
  • Primary care provider must establish and maintain a physician-patient relationship with each patient provided drug therapy management under the CPA.
• Are there filing requirements?
  • Yes, notice of pharmacist entering into a CPA must be submitted to the Board of Pharmacy for approval.
  • Pharmacist must keep a written copy of CPA on file.
• Are there content requirements?
  • Yes, CPA must identify the following: 1) collaborating pharmacist; 2) collaborating primary care provider; and 3) description of scope of services covered under agreement.
    • Primary care provider must be geographically close enough that they can be physically present to supervise pharmacist as needed.
  • Regarding the scope of services, the agreement must explicitly specify the decisions the pharmacist is authorized to make. This includes the types of diseases, drugs, or drug categories involved and the type of collaborative authority. The agreement must state the procedures, decision criteria, or plans the pharmacists are to follow when making therapeutic decisions, particularly when modification or initiation of drug therapy is involved.
  • Granting authority to pharmacist to provide services outside of the primary care practitioner’s scope of practice is explicitly prohibited.
  • CPA must establish a means for the primary care provider and pharmacist to communicate.
  • CPA must state the conditions and events for which the pharmacist must notify the primary care provider.
  • CPA must identify what laboratory tests (if any) pharmacist is authorized to order.
  • If CPA grants pharmacist authority to implement or modify a patient’s drug therapy, the collaborating primary care practitioner must first assess and diagnose the patient and relay a specific drug therapy order to the pharmacist.
  • CPA cannot grant pharmacist authority to prescribe dangerous drugs* if said pharmacist practices in any setting other than a federally qualified health center, hospital, hospital-based clinic, or an academic health care institution.
    • *A dangerous drug is defined as any drug that is either 1) unsafe for self-medication AND that is not included in Schedules I through V or Penalty Groups 1 through 4 as listed in the Texas Controlled Substances Act or 2) is labeled as “Rx Only.” Tex. Occ. Code Ann. § 551.003
  • Is there a time period limit?
    • Yes, CPA must be renewed every year.
  • Is the pharmacist required to undergo additional training?
    • Yes, pharmacist must have completed six-hours of ACPE-approved continuing education related to drug therapy offered by a provider and have engaged in drug therapy management. Both requirements must have been completed within the last year, and a statement attesting to completion must be provided to the Board of Pharmacy within 24 hours of requesting the Board to approve CPA.
    • A pharmacist engaged in drug therapy management must complete six hours of ACPE-approved continuing education related to drug therapy each year.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes. Tex. Ins. Code Ann. § 1451.1261.
    • Does the law/regulation apply to specific services?
      • No.
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • Yes. Every health care service plan that offers coverage for a service that is within a pharmacist’s scope of practice must reimburse the pharmacist at a rate equal to what the insurer would reimburse a primary care provider for the same service.
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Law applies to all health insurance carriers.

ORAL PrEP: Statute gives pharmacists the authority to independently initiate PrEP and PEP (effective since September 2021)

• H. B. 178 (Utah 2021).
• Utah Code Ann. § 58-17b-627
• UT ADC R156-17b-627
• https://dopl.utah.gov/wp-content/uploads/2022/09/utah-guidance-for-pre-exposure-and-post-exposure-prophylaxis-of-hiv.pdf
• Does the pharmacist need a standing order from a primary care provider?
  • No, the pharmacist does not need a standing order from a primary care practitioner.
  • Pharmacists are required to inform a patient’s primary care provider (if the patient has one) if the pharmacist prescribes PrEP or PEP.
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • No, Utah law does not address pharmacist’s reimbursement or other insurance provisions regarding PrEP and PEP related services.
• Is there a quantity limit for prescriptions?
  • No, Utah law does not impose quantity limits on pharmacy-initiated PrEP nor limit the frequency with which pharmacists can prescribe PrEP or PEP to a given patient.
• Does the pharmacist have to undergo additional training?
  • No, the pharmacist does not have to undergo additional training.
  • When prescribing PrEP and PEP, the pharmacist must follow the statewide protocol established by the Division of Occupational and Professional Licensing.

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Utah Code Ann. § 58-17b-102
• Definition of scope of practice includes administration
• Administration explicitly includes drug administration by injection

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• Utah Code Ann. § 58-17b-102
• Utah Code Ann. § 58-17b-601
• Utah Admin. Code r. R156-17b-611
• Does CPA need to be patient-specific?
  • No, CPA does not need to be patient-specific.
• Are there filing requirements?
  • No, there are not filing requirements.
• Are there content requirements?
  • Yes, CPA must be in writing and signed by collaborating pharmacist and primary care provider.
• Is there a time period limit?
  • No, there is not a time period limit.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No. U.A.C. R156-17b-611
  • [However, pharmacists may order HIV-related laboratory tests for the purpose of initiating PrEP.]
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • No

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes
  • Medication Therapy Management Services - Medicaid: Utah Department of Health and Human Services - Integrated Healthcare
    • Does the law/regulation apply to specific services?
      • Medicaid-enrolled pharmacists in an outpatient setting are eligible for reimbursement for providing medication therapy management (MTM) services.
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP:  Statewide protocol gives pharmacists the authority to independently initiate PrEP and PEP (effective since December 2021)

• H.B. 2079 (Va. 2021).
• Va. Code Ann. § 54.1-3300
• Va. Code Ann. § 54.1-3303.1
• Virginia Board of Pharmacy, HIV Pre-Exposure Prophylaxis (PrEP) Statewide Protocol (Dec. 2021), available at https://www.dhp.virginia.gov/pharmacy/docs/protocols/PrEPCombinedProtocol12-22-2021.pdf
• Does the pharmacist need a standing order from a primary care provider?
  • No, the pharmacist does not need a standing order from a primary care provider.
  • Pharmacists are required to inform a patient’s primary care provider if the pharmacist prescribes PrEP or PEP. If the patient does not have a primary care provider, then the pharmacist must provide a list of local primary care providers.
• Does the legislation address pharmacist’s reimbursement or other insurance provisions?
  • No, Virginia law does not address pharmacist’s reimbursement or other insurance provisions regarding PrEP and PEP related services.
• Is there a quantity limit for prescriptions?
  • No, Virginia law does not impose quantity limits on pharmacy-initiated PrEP nor limit the frequency with which pharmacists can prescribe PrEP or PEP to a given patient.
• Does the pharmacist have to undergo additional training?
  • Yes, pharmacists are required to complete a comprehensive training program related to the prescribing and dispensing of HIV prevention and medications.
  • When prescribing PrEP and PEP, the pharmacist must follow the statewide protocol established by the Virginia Board of Pharmacy.

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Va. Code Ann. § 54.1-3300
• Definition of scope of practice includes administration
• Administration is interpreted to be included within the definition of dispense

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• Va. Code Ann. § 54.1-3300
• Va. Code Ann. § 54.1-3300.1
• 18 Va. Admin. Code 110-40-10 –– 70
• Does CPA need to be patient-specific?
  • Yes, CPA must be patient-specific.
  • Patient must be notified of existence and scope of CPA and provide written consent.
• Are there filing requirements?
  • No, there are not filing requirements (so long as CPA’s scope is within the clinically-accepted standard of care).
  • Pharmacist and primary care practitioner must each keep a written copy of CPA and patient’s consent on file.
• Are there content requirements?
  • Yes, CPA must describe the disease state or condition, drugs or drug categories, drug therapies, laboratory tests, medical devices, and substitutions authorized by the primary care practitioner.
  • CPA must outline the procedures, decision criteria, or plan the pharmacist must follow when providing drug therapy management.
  • CPA must outline how/if pharmacist must document services provided pursuant to the agreement.
  • CPA must state the conditions and events for which the pharmacist must notify the primary care provider.
  • CPA must specify a timeline for the agreement to be reviewed/renewed periodically.
  • CPA must include a clause granting primary care practitioner the authority to override the agreement if necessary to protect the health of the patient or accomplish the goals of the treatment prescribed for the patient.
  • CPA must include a statement pharmacist, primary care provider, or patient may terminate agreement at any time.
  • CPA must be related to treatment using drug therapy, laboratory tests, or medical devices that is defined under specific conditions or limitations and is for the purpose of improving patient outcomes.
  • Primary care practitioner includes advance practice registered nurses.
• Is there a time period limit?
  • No, there is not a time period limit.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes, for limited services.
  • Chapter-4 Covered Services and Limitations (Pharmacy).pdf (virginia.gov)
  • Pharmacy Chapter 5 (updated 2.13.23)_Final.pdf (virginia.gov)
    • Does the law/regulation apply to specific services?
      • Pharmacists can be reimbursed for providing the influenza vaccine, birth control pills, other family planning devices (e.g., condoms), and nutritional supplements.
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• 20-4 Vt. Code R. § 1400
• Definition of scope of practice includes administration
• Administration explicitly includes drug administration by injection

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• Vt. Stat. Ann. tit. 26, § 2022(15)(B)(iii)
• Vt. Stat. Ann. tit. 26, § 2023 
• Vt. Admin. Code 20-4-26:1
• Vt. Admin. Code 20-4-1400:1.10(a)(8)
• Does CPA need to be patient-specific?
  • No, the CPA does not need to be patient-specific.
• Are there filing requirements?
  • No, there are not filing requirements.
  • CPA must be readily available to any patient or regulatory authority that may request it.
• Are there content requirements?
  • Yes, the CPA must: 1) permit prescribing only when there is an established patient-physician relationship between the patient and the collaborating primary care practitioner; 2) contain the name, license number, and dated signature of the collaborating primary care practitioner; 3) specify start and end dates of the agreement separated by not more than one year; 4) and describe the scope of clinical pharmacy services and/or prescribing to be provided, including any limitations on the scope of those services.
  • CPA must require pharmacist and primary care practitioner to notify one another of any changes to a patient’s drug therapy or medical status.
• Is there a time period limit?
  • Yes, CPA must be renewed every year.
• Is the pharmacist required to undergo additional training?
  • No, pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes, for limited services.
  • Vermont Medicaid Provider Manual
  • Provider Manual _0.pdf (vermont.gov)
    • Does the law/regulation apply to specific services?
      • Pharmacies can be reimbursed for ACIP approved vaccines and immunizations (cost of the vaccine + administration fee).
      • Pharmacists can conduct and be reimbursed for medically necessary EPSDT screenings/services with prior authorization.
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Wash. Rev. Code Ann. § 18.64.011
• Definition of scope of practice includes administration
• Administration explicitly includes drug administration by injection

CPA: Statute permits pharmacist to enter into a CPA with a primary care provider

• Wash. Rev. Code Ann. § 18.64.011(28)
• Wash. Admin. Code 246-945-350
• Does CPA need to be patient-specific?
  • No, CPA does not need to be patient-specific.
• Are there filing requirements?
  • Yes, pharmacist must submit a copy of CPA to the pharmacy quality assurance commission.
  • Pharmacist must keep a written copy of CPA on file.
• Are there content requirements?
  • Yes, CPA must identify the following: 1) collaborating pharmacist; 2) collaborating primary care provider; and 3) scope of services covered under agreement.
  • Regarding the scope of services, the agreement must explicitly specify the decisions the pharmacist is authorized to make. This includes the types of diseases, drugs, or drug categories involved and the type of collaborative authority. The agreement must state the procedures, decision criteria, or plans the pharmacists are to follow when making therapeutic decisions, particularly when modification or initiation of drug therapy is involved.
  • CPA must outline how/if pharmacist must document services provided pursuant to the agreement.
  • CPA must outline a plan for communication or feedback to the primary care practitioner concerning specific decisions made by the pharmacist.
• Is there a time period limit?
  • Yes, CPA must be renewed every two years.
• Is the pharmacist required to undergo additional training?
  • No, pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes, see WAC 182-530-7250: ; WAC 182-531-0100: ; WAC 182-531-0250: ; WAC 182-502-0002:
    • Does the law/regulation apply to specific services?
      • Long list of covered/reimbursable services in WAC 182-531-0100, including vaccines, HIV/AIDS counseling/testing (WAC 182-531-0600:), tobacco/nicotine cessation counseling (WAC 182-531-1720:), and reproductive health services (including OTC and emergency contraception).
    • Does the law/regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

RCW 48.43.094: When a pharmacist provides healthcare services (including those under CPA), insurers must cover said services in the same manner as if the services had been provided by a primary care provider.

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Wis. Stat. Ann. § 450.01
• Definition of scope of practice includes administration
• Administration explicitly includes drug administration by injection

CPA: Statute permits a pharmacist to enter into a CPA with a primary care provider.

• Wis. Stat. Ann. § 450.033
• Wis. Stat. Ann. § 49.46(2)(bh) (state Medicaid to cover services performed by pharmacist under CPA)
• Wis. Admin. Code § 7.12
• Does CPA need to be patient-specific?
  • No, the CPA does not need to be patient-specific.
• Are there filing requirements?
  • No, there are no filing requirements.
  • The pharmacist shall document the delegation by a physician, and the delegated act may not be started prior to documentation.
• Are there content requirements?
  • No, there are no content requirements.
• Is there a time period limit?
  • No, there is not a time period limit.
  • The documentation (see filing requirements) shall be maintained for a minimum of 5 years after the end of the last delegated act.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes, see Online Handbook Display (wi.gov)
    • Does the law/regulation apply to specific services?
      • Pharmacists can be reimbursed for providing medication therapy management (MTM) services. The MTM benefit consists of Comprehensive Medication Review and Assessment services, which are private consultations between a pharmacist and a member to review the member's drug regimen.
      • Wisconsin Medicaid fee-for-service also reimburses pharmacy providers for influenza immunization services for both children and adult members and for allowable vaccines for children 6–18 years of age, even if the member is enrolled in a state-contracted MCO.
    • Does the law/regulation require parity (or equity) between pharmacists and other providers?
      • No
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?
      • Medicaid

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• W. Va. Code R. 15-1-2
• Definition of scope of practice includes dispensing
• Dispensing includes drug administration
• Administration explicitly includes drug administration by injection

CPA: Statute permits a pharmacist to enter into a CPA with a primary care provider.

• W. Va. Code Ann. § 30-5-18
• W. Va. Code Ann. § 30-5-19
• W. Va. Code R. 11-8-3
• W. Va. Code R. 11-8-4
• W. Va. Code R. 11-8-5
• Does CPA need to be patient-specific?
  • No, the CPA does not need to be patient-specific.
• Are there filing requirements?
  • Yes, the parties must file a complete practice notification with the Board of Pharmacy before the CPA becomes effective. The practice notification shall include 1) the full name, license number, licensing board, preferred mailing address, telephone number, and email address of the pharmacist(s) and physician(s) who are entering into the CPA; 2) the name and address of each location where the pharmacist will engage in collaborative practice pursuant to the CPA; 3) the proposed effective date; and 4) certification by the collaborating pharmacist and physician that a) the pharmacist has been verified as eligible for the CPA by the Board, b) the physician is eligible to serve as a collaborating physician, c) the CPA is consistent with the physician’s scope of practice, the pharmacist’s education, training, and experience, and includes, at a minimum, the content required by statute, d) the pharmacist will maintain a copy of the CPA at their place of practice and will provide a copy to any of the boards upon request, e) collaborative practice shall only be performed after informed consent of the patient, noted in the medical record, and f) the parties acknowledge that the CPA does not include management of controlled substances.
  • The pharmacist must have the CPA on file at his or her place of practice. The existence and subsequent termination of the agreement and any additional information the rules may require concerning the agreement, including the agreement itself, shall be made available to the appropriate licensing board for review upon request.
• Are there content requirements?
  • Yes, each protocol developed pursuant to the CPA shall include 1) the specific drug(s) to be managed by the pharmacist; 2) the terms and conditions under which drug therapy may be implemented, modified, or discontinued; 3) the conditions and events upon which the pharmacist is required to notify the physician; 4) the lab tests that may be ordered in accordance with drug therapy management; and 5) the mutually agreed upon patient evaluations the pharmacist may conduct.
• Is there a time period limit?
  • No, there is no time period limit, but either party may terminate the CPA at any time.
  • The CPA automatically terminates if either the collaborating pharmacist(s) or collaborating physician(s) are no longer eligible to collaborate.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law/regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Broad authority to administer injectable PrEP

• Wyo. Admin. Code 059.0001.2 § 4
• Definition of scope of practice includes dispense
• Administration is interpreted to be included within the definition of dispense
• Administration explicitly includes drug administration by injection

CPA: Statute permits a pharmacist to enter into a CPA with a primary care provider.

• Wyo. Stat. Ann. § 33-24-101(b)(iii)
• Does CPA need to be patient-specific?
  • No, the CPA does not need to be patient-specific.
• Are there filing requirements?
  • No, there are not filing requirements.
• Are there content requirements?
  • No, there are not content requirements.
• Is there a time period limit?
  • No, there is no time period limit.
• Is the pharmacist required to undergo additional training?
  • No, the pharmacist is not required to undergo additional training.

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • Yes. Wyo. Admin. Code 059.0001.20 § 4
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • No.

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No
    • Does the law/regulation apply to specific services?
    • Does the law/regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: Pharmacist may only administer injectable PrEP if under the authority of a CPA with a primary care provider

• 20 L.P.R.A. § 407
• 20 L.P.R.A. § 407b

CPA: N/A

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?
  • N/A

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • Yes/No
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?

Medicaid Pharmacy Reimbursement: https://www.salud.gov.pr/menuInst/download/1502

ORAL PrEP: Neither statute nor statewide standing order/protocol gives pharmacists the authority to independently initiate PrEP or PEP

INJECTABLE PrEP/CABROTEGRAVIR: N/A

CPA: N/A

LABORATORY TESTS:

• Are pharmacists allowed to independently perform CLIA-waived tests?
  • No specific statute specifically allowing or prohibiting pharmacists from providing CLIA-waived tests.
• Are there limitations to which CLIA-waived tests a pharmacist may perform independently?

REIMBURSEMENT:

• Does the state have a provider status law or regulation, requiring reimbursement for pharmacist provided clinical services?
  • No.
    • Does the law/regulation apply to specific services?
    • Does the law /regulation require parity (or equity) between pharmacists and other providers?
    • Does the law/regulation apply to Medicaid, state employee benefits, and/or private insurance regulated by the state?