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HB 654

Pharmacists/Vaccine Administration/Test and Treat.

2023-2024 Session Introduced by John Autry and 12 co-sponsors

Expands pharmacists' scope to vaccinate, order/perform CLIA-waived tests, and test-and-treat common illnesses with fair reimbursement, boosting local access and continuity of care.

Passed 1st Reading
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Bill Summary · HB 654

HB 654 — Pharmacists: Vaccine Administration; Test-and-Treat; Reimbursement

Status: Introduced Nov 12, 2024; legislative actions indicate final passage and executive approval (signed by Governor 06/20/2025; effective 09/01/2025). Jurisdiction: North Carolina (text authored as North Carolina General Assembly).

Purpose / Intent

To expand pharmacists’ scope of practice by (1) broadening the vaccines pharmacists may administer and lowering minimum patient ages for certain vaccines; (2) authorizing pharmacists to order and perform CLIA‑waived tests and to “test and treat” selected acute illnesses under Board‑approved protocols; and (3) establishing fair and equitable reimbursement for pharmacist‑provided health services equivalent to those provided by other health professionals.

Key provisions

  • Definitions: Adds/clarifies terms including ACIP, CLIA‑waived test, clinical pharmacist practitioner, and FDA.
  • CLIA‑waived testing authority:
    • Pharmacists may order and perform CLIA‑waived tests to support medication use/monitoring and to screen for specified conditions.
    • Test‑and‑treat authority: Pharmacists may treat influenza, COVID‑19, group A streptococcal pharyngitis, and other board‑specified conditions when screening is done via CLIA‑waived tests and when following Board of Pharmacy protocols (developed in consultation with the State Health Director and Medical Board).
    • Explicit prohibition on treating these conditions with controlled substances (Schedules I–IV).
  • Expanded immunization authority:
    • Immunizing pharmacists may administer FDA‑authorized or ACIP‑recommended vaccines under written protocols.
    • Vaccine age thresholds lowered in some provisions (e.g., several vaccines may be given to persons age 3 and older under specified protocols; influenza and certain COVID‑19 vaccines to younger ages under particular conditions and prescribing structures).
    • Supervising physician requirements retained for some protocols; some vaccines require a specific prescription when administered to younger patients.
  • Documentation and communication:
    • Pharmacists must maintain vaccine records in patient profiles.
    • Pharmacists must notify identified primary care providers (or pediatricians for minors) within 72 hours after vaccine administration; if no PCP is identified, pharmacists must provide information about primary care benefits.
  • Oversight and implementation:
    • Board of Pharmacy to adopt rules and protocols in consultation with State Health Director and Medical Board.
    • Clinical pharmacist practitioners and pharmacist‑supervised interns/technicians may have limited roles under supervision and training requirements.
  • Reimbursement: The bill directs fair and equitable reimbursement for pharmacist‑performed services that are equivalent to services performed by other health care professionals (details subject to implementing rules and payer policies).

Who is affected

  • Pharmacists, pharmacy interns and technicians (expanded clinical duties and training/recordkeeping requirements).
  • Patients (improved local access to testing, vaccines, and timely treatment, including some younger age groups).
  • Primary care providers and pediatricians (notification and continuity-of-care interactions).
  • Payers (private insurers, Medicaid) — reimbursement practices may change.
  • Board of Pharmacy, State Health Director, and Medical Board (rulemaking and protocol development).

Potential impacts and considerations

  • Public health: May increase timely access to vaccines and early treatment for common infections; potential to reduce transmission and healthcare visits.
  • Operational: Pharmacies will need CLIA‑waived testing capacity, staff training, documentation systems, and protocols.
  • Financial: Potential revenue for pharmacies from expanded services; payers may face new claims and rate negotiations for pharmacist services.
  • Safeguards: Controlled‑substance prescribing is prohibited under the test‑and‑treat authority; protocol and notification requirements aim to preserve continuity of care.

Timeline / Next steps

  • Board of Pharmacy and cooperating agencies must adopt implementing rules and clinical protocols before full operationalization.
  • Payers and pharmacies will need to align billing/reimbursement and workflows in anticipation of the effective date (noted in the legislative actions as 09/01/2025).

Compiled from official sources — confirm details with the bill’s official record.

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