Title of Regulation: 18VAC90-40. Regulations for Prescriptive Authority for Nurse Practitioners (amending 18VAC90-40-10, 18VAC90-40-40, 18VAC90-40-60, 18VAC90-40-90, 18VAC90-40-110, 18VAC90-40-130; repealing 18VAC90-40-100).

Statutory Authority: §§ 54.1-2400 and 54.1-2957.01 of the Code of Virginia.

Public Hearing Information:

October 8, 2014 - 9 a.m. - Department of Health Professions, Perimeter Center, 9960 Mayland Drive, Suite 201, Richmond, VA 23233

Public Comment Deadline: November 21, 2014.

Agency Contact: Jay P. Douglas, R.N., Executive Director, Board of Nursing, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4515, FAX (804) 527-4455, or email jay.douglas@dhp.virginia.gov.

Basis: Regulations are promulgated under the general authority of Chapter 24 of Title 54.1 of the Code of Virginia. Section 54.1-2400 of the Code of Virginia provides the Boards of Nursing and Medicine the authority to promulgate regulations to administer the regulatory system. The specific mandate to promulgate regulations for the prescriptive authority for nurse practitioners is found in § 54.1-2957.01 of the Code of Virginia:

Purpose: The proposed amendments achieve the goal of increasing access chiefly by elimination of identified obstacles, such as the current requirement for the physician to regularly practice or make site visits to the setting where nurse practitioners prescribe. Through appropriate collaboration and consultation, patient health and safety are protected by having an agreement between parties that includes the prescriptive authority for the nurse practitioner.

Substance: The following changes are proposed: (i) definitions are revised for consistency with definitions in §§ 54.1-2900 and 54.1-3000 of the Code of Virginia; (ii) provisions relating to a practice agreement are amended to delete the requirement for the agreement to be submitted to the boards and approved prior to issuance of an authorization or following a revision of an agreement and to require that the practice agreement either be signed or clearly state the name of the physician who has entered into the practice agreement; (iii) the previous ratio of four nurse practitioners with prescriptive authority for each supervising physician has been increased to six nurse practitioners per patient care team physician; (iv) 18VAC90-40-100 is being repealed because it is inconsistent with the model of collaboration and consultation of a patient care team (the requirement for the physician to regularly practice in the same location was eliminated by Chapter 213 of the 2012 Acts of Assembly); (v) requirements for prescriber information on prescriptions are amended for consistency with requirements for other types of prescribers; and (vi) requirements on disclosure to patients are amended for consistency with subdivision E 1 of § 54.1-2957.01 of the Code of Virginia.

Issues: The most significant benefit is to the patients/clients in Virginia who may benefit from an expansion of care by nurse practitioners since they are not required to practice in the same location as the patient care team physician and are able to deliver care in a collaborative approach in which each member of the team practices to the extent of his training. There are no disadvantages to the public. There are no specific advantages to the agency or to the Commonwealth except possibly better utilization of nurse practitioners throughout underserved parts of the state. There are no disadvantages.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapter 213 of the 2012 Acts of the Assembly, the Boards of Nursing and Medicine (Boards) propose to amend these Regulations Governing Prescriptive Authority for Nurse Practitioners so that they are consistent with the model of collaboration for patient care teams. Specifically, the Boards propose to:

1. Revise provisions relating to practice agreements to delete the requirement that they be submitted to the Boards for approval prior to their issuance or revision and to allow such agreements to be in electronic form,

2. Replace the number of nurse practitioners that each supervising physician may supervise (4) so that these regulations comport with Code changes that allow six nurse practitioners to work in collaboration and consultation with each patient care team physician,

3. Repeal 18VAC90-40-100 which has rules supervision of nurse practitioners and site visits as these rules are not consistent with the model of collaboration and consultation laid out in Chapter 213, and

4. Amend disclosure requirements to eliminate the requirement for nurse practitioners who have a Drug Enforcement Administration (DEA) number to also have a Board issued prescriptive authority number and also mandate that nurse practitioners disclose to patients on their first contact that they are being treated by a licensed nurse practitioner. The Boards also propose to change the requirement that patients also automatically receive the name and contact information of the nurse practitioner's supervising physician to a requirement that such information (for the patient care team physician) be disclosed upon request of the patient.

Result of Analysis. Benefits likely outweigh costs for these proposed regulatory changes.

Estimated Economic Impact. Currently, these regulations require written practice agreement between nurse practitioners and supervising physicians to be submitted for approval by the Boards before they can be initially implemented and when they are revised. As the authorizing law does not require that practice agreements go through a board approval process, the Boards now propose to eliminate that step and instead only require affected nurse practitioners and patient care team physicians to develop, and maintain an electronic or written copy of, a practice agreement that includes information required by the Code of Virginia (Code) or these regulations. These changes will likely benefit patient care team physicians and nurse practitioners as it eliminates one of the steps they must currently complete before they can start cooperatively caring for patients under a practice agreement and it allows them to complete practice agreements electronically. No entity is likely to incur costs or harm from this change because practice agreements will still have to include all information required by Code or regulation.

Current regulations allow supervising physicians to supervise up to four nurse practitioners with prescriptive authority. These regulations also lay out rules for supervision that require supervising physicians, with some exceptions, to "regularly practice" in the same location as the nurse practitioners with prescriptive authority that he supervises. Revisions to the Code now allow patient care team physicians to supervise up to six nurse practitioners with prescriptive authority and set a model for collaboration and consultation of a patient care team that is inconsistent with current regulations. Specifically, Code revisions eliminated the requirement that physicians practice in the same location as the nurse practitioners with whom they collaborate. The Boards now propose to amend these regulations by updating the numbers of nurse practitioners that may be on a patient care team with a physician and repealing the section that sets rules for supervision and site visits (18VAC90-40-100). These changes will benefit physicians and nurse practitioners as they allow greater flexibility to arrange patient care teams to increase efficiency and increase the amount of care that can be offered to patients. These changes will also provide a benefit by removing current inconsistencies between these regulations and the Code as revised.

Current regulations require all nurse practitioners with prescriptive authority to have a prescriptive authority number issued by the Boards. All nurse practitioners with prescriptive authority who prescribe any drugs but Schedule VI drugs must also have a DEA number. The Board proposes to eliminate the need to obtain a prescriptive authority number for those who already have a DEA number and only retain this requirement for nurse practitioners who solely prescribe Schedule VI drugs. This change will benefit affected nurse practitioners as it eliminates the need to obtain a prescriptive authority number that is duplicative in use to their DEA number and will also eliminate any confusion that might arise as to which number is supposed to be included on prescriptions.

Currently, nurse practitioners are required to disclose that they are nurse practitioners to patients and to also disclose the name and contact information for their supervising physician. Regulations do not, however, set a timeframe for this information to be disclosed. To make these regulations consisted with the Code as it was revised, the Boards proposes to require nurse practitioners to disclose that they are nurse practitioners on their first contact with patients. Nurse practitioners will also be required to give the name and contact information for the patient care team physician upon request of the patient. These changes will benefit all interested parties as they bring these regulations into conformity with the Code so that any possible confusion is eliminated.

Businesses and Entities Affected. The Department of Health Professions (DHP) reports these proposed regulatory changes will affect the 4,641 nurse practitioners with prescriptive authority for controlled substances.

Localities Particularly Affected. No localities will be particularly affected by these proposed regulatory changes.

Projected Impact on Employment. Code changes that increase the number of nurse practitioners that may work under practice agreements with any given physician may increase employment opportunities for nurse practitioners in the Commonwealth.

Effects on the Use and Value of Private Property. To the extent that these regulatory changes, and the Code revisions that drive them, increase business opportunities and profits for affected nurse practitioners and patient care team physicians, the value of their licenses will likely also increase.

Small Businesses: Costs and Other Effects. No affected small business is likely to incur costs on account of these proposed regulations.

Small Businesses: Alternative Method that Minimizes Adverse Impact. No affected small business is likely to incur costs on account of these proposed regulations.

Real Estate Development Costs. This regulatory action will likely have no effect on real estate development costs in the Commonwealth.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

Agency's Response to Economic Impact Analysis: The Board of Nursing concurs with the economic impact analysis prepared by the Department of Planning and Budget.

Summary:

The proposed amendments revise (i) requirements for prescriptive authority for nurse practitioners consistent with a model of collaboration and consultation with a patient care team physician working under a mutually agreed-upon practice agreement within a patient care team and (ii) terminology and criteria for practice consistent with changes to the Code of Virginia as enacted in Chapter 213 of the 2012 Acts of the Assembly.

Part I
General Provisions

18VAC90-40-10. Definitions.

The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"Boards" means the Virginia Board of Medicine and the Virginia Board of Nursing.

"Committee" means the Committee of the Joint Boards of Nursing and Medicine.

"Nonprofit health care clinics or programs" means a clinic organized in whole or in part for the delivery of health care services without charge or when a reasonable minimum fee is charged only to cover administrative costs.

"Nurse practitioner" means a an advanced practice registered nurse who has met the requirements for licensure as a nurse practitioner as stated in 18VAC90-30.

"Practice agreement" means a written or electronic agreement jointly developed by the supervising patient care team physician and the nurse practitioner for the practice of the nurse practitioner that also describes and directs the prescriptive authority of the nurse practitioner, if applicable.

"Supervision" means that the physician documents being readily available for medical consultation with the licensed nurse practitioner or the patient, with the physician collaborating with the nurse practitioner for the agreed-upon course of treatment and medications prescribed.

18VAC90-40-40. Qualifications for initial approval of prescriptive authority.

An applicant for prescriptive authority shall meet the following requirements:

1. Hold a current, unrestricted license as a nurse practitioner in the Commonwealth of Virginia; and

2. Provide evidence of one of the following:

a. Continued professional certification as required for initial licensure as a nurse practitioner; or

b. Satisfactory completion of a graduate level course in pharmacology or pharmacotherapeutics obtained as part of the nurse practitioner education program within the five years prior to submission of the application; or

c. Practice as a nurse practitioner for no less than 1000 hours and 15 continuing education units related to the area of practice for each of the two years immediately prior to submission of the application; or

d. Thirty contact hours of education in pharmacology or pharmacotherapeutics acceptable to the boards taken within five years prior to submission of the application. The 30 contact hours may be obtained in a formal academic setting as a discrete offering or as noncredit continuing education offerings and shall include the following course content:

(1) Applicable federal and state laws;

(2) Prescription writing;

(3) Drug selection, dosage, and route;

(4) Drug interactions;

(5) Information resources; and

(6) Clinical application of pharmacology related to specific scope of practice.

3. Submit Develop a practice agreement between the nurse practitioner and the supervising patient care team physician as required in 18VAC90-40-90. The practice agreement must be approved by the boards prior to issuance of prescriptive authority; and

4. File a completed application and pay the fees as required in 18VAC90-40-70.

18VAC90-40-60. Reinstatement of prescriptive authority.

A. A nurse practitioner whose prescriptive authority has lapsed may reinstate within one renewal period by payment of the current renewal fee and the late renewal fee.

B. A nurse practitioner who is applying for reinstatement of lapsed prescriptive authority after one renewal period shall:

1. File the required application and a new practice agreement;

2. Provide evidence of a current, unrestricted license to practice as a nurse practitioner in Virginia;

3. Pay the fee required for reinstatement of a lapsed authorization as prescribed in 18VAC90-40-70; and

4. If the authorization has lapsed for a period of two or more years, the applicant shall provide proof of:

a. Continued practice as a licensed nurse practitioner with prescriptive authority in another state; or

b. Continuing education, in addition to the minimal requirements for current professional certification, consisting of four contact hours in pharmacology or pharmacotherapeutics for each year in which the prescriptive authority has been lapsed in the Commonwealth, not to exceed a total of 16 hours.

C. An applicant for reinstatement of suspended or revoked authorization shall:

1. Petition for reinstatement and pay the fee for reinstatement of a suspended or revoked authorization as prescribed in 18VAC90-40-70;

2. Present evidence of competence to resume practice as a nurse practitioner with prescriptive authority; and

3. Meet the qualifications and resubmit the application required for initial authorization in 18VAC90-40-40.

Part III
Practice Requirements

18VAC90-40-90. Practice agreement.

A. A nurse practitioner with prescriptive authority may prescribe only within the scope of a the written or electronic practice agreement with a supervising patient care team physician to be submitted with the initial application for prescriptive authority.

B. At any time there are changes in the primary supervising patient care team physician, authorization to prescribe, or scope of practice, the nurse practitioner shall submit a revised revise the practice agreement to the board and maintain the revised agreement.

C. The practice agreement shall contain the following:

1. A description of the prescriptive authority of the nurse practitioner within the scope allowed by law and the practice of the nurse practitioner.

2. An authorization for categories of drugs and devices within the requirements of § 54.1-2957.01 of the Code of Virginia.

3. The signatures of the primary supervising physician and any secondary physician who may be regularly called upon in the event of the absence of the primary physician signature of the patient care team physician who is practicing with the nurse practitioner or a clear statement of the name of the patient care team physician who has entered into the practice agreement.

D. In accordance with § 54.1-2957.01 of the Code of Virginia, a physician shall not serve as a patient care team physician to more than six nurse practitioners with prescriptive authority at any one time.

18VAC90-40-100. Supervision and site visits. (Repealed.)

A. In accordance with § 54.1-2957.01 of the Code of Virginia, physicians who enter into a practice agreement with a nurse practitioner for prescriptive authority shall supervise and direct, at any one time, no more than four nurse practitioners with prescriptive authority.

B. Except as provided in subsection C of this section, physicians shall regularly practice in any location in which the licensed nurse practitioner exercises prescriptive authority.

1. A separate practice setting may not be established for the nurse practitioner.

2. A supervising physician shall conduct a regular, random review of patient charts on which the nurse practitioner has entered a prescription for an approved drug or device.

C. Physicians who practice with a certified nurse midwife or with a nurse practitioner employed by or under contract with local health departments, federally funded comprehensive primary care clinics, or nonprofit health care clinics or programs shall:

1. Either regularly practice at the same location with the nurse practitioner or provide supervisory services to such separate practices by making regular site visits for consultation and direction for appropriate patient management. The site visits shall occur in accordance with the protocol, but no less frequently than once a quarter.

2. Conduct a regular, random review of patient charts on which the nurse practitioner has entered a prescription for an approved drug or device.

18VAC90-40-110. Disclosure.

A. The nurse practitioner shall include on each prescription written or dispensed his signature and prescriptive authority number as issued by the boards and the Drug Enforcement Administration (DEA) number, when applicable. If his practice agreement authorizes prescribing of only Schedule VI drugs and the nurse practitioner does not have a DEA number, he shall include the prescriptive authority number as issued by the boards.

B. The nurse practitioner shall disclose to patients at the initial encounter that he is a licensed nurse practitioner and the name, address and telephone number of the supervising physician. Such disclosure may be included on a prescription pad or may be given in writing to the patient.

C. The nurse practitioner shall disclose, upon request of a patient or a patient's legal representative, the name of the patient care team physician and information regarding how to contact the patient care team physician.

Part IV
Discipline

18VAC90-40-130. Grounds for disciplinary action.

A. The boards may deny approval of prescriptive authority, revoke or suspend authorization, or take other disciplinary actions against a nurse practitioner who:

1. Exceeds his authority to prescribe or prescribes outside of the written practice agreement with the supervising patient care team physician;

2. Has had his license as a nurse practitioner suspended, revoked, or otherwise disciplined by the boards pursuant to 18VAC90-30-220;

3. Fails to comply with requirements for continuing competency as set forth in 18VAC90-40-55.

B. Unauthorized use or disclosure of confidential information received from the Prescription Monitoring Program shall be grounds for disciplinary action.