4.3 Collaborative Practice Agreements (CPAs) in Virginia

4.3 Collaborative Practice Agreements (CPAs) in Virginia

Collaborative drug therapy management represents a high level of clinical interprofessional practice in the Commonwealth of Virginia. Codified in the Code of Virginia at § 54.1-3300.1 and governed by joint regulations of the Board of Pharmacy and Board of Medicine at 18VAC110-40-10 et seq., a Collaborative Practice Agreement (CPA) establishes a formal clinical partnership between pharmacists and medical practitioners.

Through a CPA, prescribers delegate specified patient management functions to pharmacists. Rather than contacting a physician for every minor dosage titration or routine refill authorization, the collaborative pharmacist exercises independent clinical judgment within the boundaries of a pre-approved, evidence-based treatment protocol.

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Contracting Parties & Eligibility Requirements

Under Va. Code § 54.1-3300.1, collaborative practice agreements may be established between one or more pharmacists and one or more physicians or healthcare practices:

1. Eligible Practitioners

• Pharmacists: Must hold an active, unrestricted license to practice pharmacy issued by the Virginia Board of Pharmacy.
• Physicians: Must hold an active, unrestricted license to practice medicine or osteopathy (MD or DO) issued by the Virginia Board of Medicine.
• Nurse Practitioners (NPs) & Physician Assistants (PAs): An advanced practice registered nurse or physician assistant may participate in a CPA, provided that their underlying practice agreement with their collaborating physician authorizes such participation, or if the NP holds an autonomous practice license under Va. Code § 54.1-2957.

2. Practice Settings

CPAs may be utilized across diverse healthcare delivery models in Virginia, including:

• Inpatient health systems and academic medical centers;
• Ambulatory care clinics and patient-centered medical homes (PCMH);
• Independent primary care and specialty medical practices; and
• Community pharmacies partnering with local physician groups for chronic disease management.

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Scope of Clinical Management Authorized Under a CPA

Under Virginia law, collaborative drug therapy management is strictly disease-state and protocol-driven. Pharmacists are authorized to perform specific clinical interventions only to the extent explicitly delineated in the written agreement.

Permissible Clinical Scope Under Virginia CPA (Va. Code § 54.1-3300.1):
├── 1. Drug Regimen Management
│   ├── Initiating new drug therapy (within protocol parameters)
│   ├── Modifying dosages, dosage forms, and administration schedules
│   ├── Continuing maintenance therapy
│   └── Discontinuing therapy due to toxicity, lack of efficacy, or goal attainment
│
├── 2. Laboratory & Diagnostic Testing
│   ├── Ordering laboratory tests (e.g., HbA1c, lipid panel, serum creatinine, INR)
│   ├── Performing point-of-care CLIA-waived diagnostic testing
│   └── Evaluating and interpreting laboratory test results
│
└── 3. Patient Physical Assessment & Monitoring
    ├── Measuring vital signs (blood pressure, pulse, weight, BMI)
    ├── Conducting disease-specific physical assessments
    └── Evaluating adherence, side effects, and therapeutic response

Clinical Scope Boundaries & Prohibitions

1. No Independent Primary Diagnosis: A CPA does not authorize a pharmacist to diagnose medical conditions. The treating physician must establish the primary medical diagnosis (e.g., diagnosing Type 2 Diabetes or Hypertension) before the patient is referred into collaborative management.
2. Controlled Substance Limitations: A collaborative agreement cannot authorize a pharmacist to prescribe Schedule II controlled substances. Delegation of Schedules III through VI controlled substances must strictly adhere to the prescriber's statutory scope and the explicit terms of the protocol.
3. Scope Alignment: A physician may only delegate management of conditions that fall within the physician's normal scope of medical practice (e.g., an orthopedic surgeon cannot enter into a CPA to manage complex psychiatric disorders).

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Mandatory Protocol and Agreement Components (18VAC110-40-40)

To be legally valid under Virginia Board regulations, every collaborative practice agreement must be in writing and contain the following mandatory statutory elements:

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Periodic Review and Rescindment (18VAC110-40-40, 18VAC110-40-60)

A frequently mis-taught point: Virginia does not fix a numeric re-execution interval for collaborative practice agreements. There is no regulation requiring annual renewal every 12 months. What 18VAC110-40-40 requires is that the signatories implement procedures for periodically reviewing the agreement and its protocol — the cadence is set by the parties in the agreement itself, not by the Board.

Two related obligations are fixed:

• Notification on change: the signatories must notify the other party when the practice location or ownership changes (18VAC110-40-40).
• Termination at will: under 18VAC110-40-60, either signatory or the patient may terminate the agreement at any time, and the practitioner may override the agreement for a specific patient at any time.

Exam trap: If an option asserts that a Virginia CPA "expires" or "must be re-executed" after a set period such as 12 or 24 months, it is describing another state's rule. Virginia's requirement is periodic review on the parties' own schedule, plus termination at will.

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Patient Informed Consent & Patient Rights (§ 54.1-3300.1)

Patient autonomy and informed consent are foundational safeguards under Virginia collaborative practice law:

• Mandatory Written Informed Consent: Prior to initiating collaborative drug therapy management, the patient (or the patient's legal guardian) must provide written informed consent.
• Required Disclosures: The consent document must clearly inform the patient that:
  1. The pharmacist will be managing their drug therapy pursuant to an agreement with their physician;
  2. The specific scope of services the pharmacist will provide (including adjusting medications and ordering tests); and
  3. The patient has the absolute statutory right to decline participation or withdraw consent at any time without compromising their relationship with their physician or their regular medical care.
• Consent Retention: A copy of the signed informed consent must be maintained in both the pharmacist's clinical record and the physician's medical chart.

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Documentation and Reporting Back to the Practitioner (18VAC110-40-40)

Virginia does not publish a fixed clock — no 24-hour, 48-hour, or 7-day deadline — for a collaborative pharmacist to notify the practitioner of a therapy change. Instead, 18VAC110-40-40 requires the agreement itself to specify the pharmacist's authorized activities including procedures for documentation and for reporting activities and results to the practitioner. The controlling timeframe is therefore whatever the executed protocol states.

Where the regulation is prescriptive is record retention under 18VAC110-40-50:

Deviating from the terms of the agreement is not a paperwork problem: under Va. Code § 54.1-3300.1 C, a pharmacist who practices inconsistently with the agreement violates § 54.1-2902 (unlawful practice of medicine), which is grounds for discipline under §§ 54.1-2400 and 54.1-3316.