Title of Regulation: 18VAC85-50. Regulations Governing the Practice of Physician Assistants (amending 18VAC85-50-115, 18VAC85-50-130, 18VAC85-50-140).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: August 7, 2019.

Effective Date: August 22, 2019.

Agency Contact: William L. Harp, M.D., Executive Director, Board of Medicine, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4558, FAX (804) 527-4429, or email william.harp@dhp.virginia.gov.

Basis: Regulations are promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which provides the Board of Medicine the authority to promulgate regulations to administer the regulatory system. The statutory provisions for practice of a physician assistant and prescriptive authority are found in § 54.1-2952 of the Code of Virginia.

Purpose: The amendments delete references to an outdated requirement for a practice agreement to be submitted and approved by the board and clarify the practice of physician assistants to further protect the health and safety of persons who receive treatment and care from such practitioners. The regulatory change is consistent with the principle that regulations should be clearly written and easily understandable.

Rationale for Using Fast-Track Rulemaking Process: As required by Executive Order 14 (2018), the Board of Medicine conducted a periodic review of this chapter. The amendments are clarifying or intended for consistency with statutory provisions. There are no substantive changes, so the amendments are not expected to be controversial.

Substance: Pursuant to its periodic review of 18VAC85-50, Regulations Governing the Practice of Physician Assistants, the board has adopted amendments to delete outdated or unnecessary language. Chapter 450 of the 2016 Acts of Assembly made substantive changes to the statutory requirements for the practice and licensure of physician assistants. An exempt regulatory action was promulgated with an effective date of October 5, 2016. However, during its periodic review of regulations, the advisory board identified several sections inconsistent with the 2016 amendment for the requirement for a practice agreement with prescriptive authority to be submitted and approved by the board.

Issues: There are no real advantages or disadvantages to the public. The amendments are clarifying and consistent with current practice and with the Code of Virginia. There are no advantages or disadvantages to the agency or the Commonwealth.

Small Business Impact Review Report of Findings: This fast-track regulatory action serves as the report of the findings of the regulatory review pursuant to § 2.2-4007.1 of the Code of Virginia.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to a periodic review,¹ the Board of Medicine (Board) proposes to remove regulatory language that is inconsistent with 2016 legislative changes and to eliminate a redundant regulatory requirement.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. The Board is proposing to eliminate ancillary language related to a previously-eliminated requirement that physician assistants (PAs) submit practice agreements to the Board for approval. The submittal requirement was eliminated in state statute with the passage of Chapter 450 of the 2016 Acts of Assembly (SB551) and implemented through an exempt regulatory action in 2016, but there still remains some language inadvertently suggesting that submittal to the Board is still required.² Further, the legislation removed the requirement that the PAs notify and provide information to the board prior to initiating practice. The legislation also required a PA to enter into a written or electronic practice agreement with at least one supervising physician or podiatrist, to maintain evidence of such agreement, and to provide it to the Board upon request rather than submit to the Board for approval.

During the periodic review, the Physician Assistant Advisory Board identified several sections that are currently inconsistent with statute. In order to address these inconsistencies, the Board proposes to remove language requiring that a separate practice agreement be executed, remove language about Board forms for practice agreements which are no longer provided by the Board and no longer required to be submitted to the Board, etc.

In addition to the changes required to conform the regulation to statute, the Board also discovered a redundant regulatory requirement during the periodic review. The regulation currently requires applicants for prescriptive authority to submit evidence of successful passage of the National Commission on Certification of Physician Assistants exam while it is simultaneously required for licensure as a PA. This regulatory action would delete the exam requirement for prescriptive authority.

Because none of the proposed changes would have any impact on current practices followed by the Board, they are not expected to create any economic impact beyond improving the accuracy of existing requirements and the consistency between the statute and the regulatory text.

Businesses and Entities Affected. The proposed amendments pertain to the 3,841 licensed physician assistants in the Commonwealth.

Localities Particularly Affected. The proposed amendments would not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendments would not affect employment.

Effects on the Use and Value of Private Property. The proposed amendments would not affect the use and value of private property.

Real Estate Development Costs. The proposed amendments would not affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. The proposed amendments would not have costs or other effects on small businesses.

Alternative Method that Minimizes Adverse Impact. The proposed amendments would not impose adverse impacts on small businesses.

Adverse Impacts:

Businesses. The proposed amendments would not impose adverse impacts on businesses.

Localities. The proposed amendments would not adversely affect localities.

Other Entities. The proposed amendments would not adversely affect other entities.

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¹http://townhall.virginia.gov/L/ViewPReview.cfm?PRid=1649

²http://townhall.virginia.gov/l/ViewStage.cfm?stageid=7650

Agency's Response to Economic Impact Analysis: The Board of Medicine concurs with the analysis of the Department of Planning and Budget.

Summary:

The amendments (i) remove regulatory language that is inconsistent with § 54.1-2952.1 of the Code of Virginia, which does not require physician assistants to submit practice agreements to the Board of Medicine for approval and (ii) eliminate a redundant regulatory requirement.

18VAC85-50-115. Responsibilities of the physician assistant.

A. The physician assistant shall not render independent health care and shall:

1. Perform only those medical care services that are within the scope of the practice and proficiency of the supervising physician as prescribed in the physician assistant's practice agreement. When a physician assistant is to be supervised by an alternate supervising physician outside the scope of specialty of the supervising physician, then the physician assistant's functions shall be limited to those areas not requiring specialized clinical judgment, unless a separate practice agreement has been executed for that alternate supervising physician is approved and on file with the board.

2. Prescribe only those drugs and devices as allowed in Part V (18VAC85-50-130 et seq.) of this chapter.

3. Wear during the course of performing his duties identification showing clearly that he is a physician assistant.

B. An alternate supervising physician shall be a member of the same group or, professional corporation, or partnership of any licensee who supervises a physician assistant or shall be a member of the same hospital or commercial enterprise with the supervising physician. Such alternating supervising physician shall be a physician licensed in the Commonwealth who has registered with the board and who has accepted responsibility for the supervision of the service that a physician assistant renders.

C. If, due to illness, vacation, or unexpected absence, the supervising physician or alternate supervising physician is unable to supervise the activities of his physician assistant, such supervising physician may temporarily delegate the responsibility to another doctor of medicine, osteopathic medicine, or podiatry.

Temporary coverage may not exceed four weeks unless special permission is granted by the board.

D. With respect to physician assistants employed by institutions, the following additional regulations shall apply:

1. No physician assistant may render care to a patient unless the physician responsible for that patient has signed the practice agreement to act as supervising physician for that physician assistant. The board shall make available appropriate forms for physicians to join the practice agreement for an assistant employed by an institution.

2. Any such practice agreement as described in subdivision 1 of this subsection shall delineate the duties which said physician authorizes the physician assistant to perform.

3. The physician assistant shall, as soon as circumstances may dictate, report an acute or significant finding or change in clinical status to the supervising physician concerning the examination of the patient. The physician assistant shall also record his findings in appropriate institutional records.

E. Practice by a physician assistant in a hospital, including an emergency department, shall be in accordance with § 54.1-2952 of the Code of Virginia.

Part V
Prescriptive Authority

18VAC85-50-130. Qualifications for approval of prescriptive authority.

An applicant for prescriptive authority shall meet the following requirements:

1. Hold a current, unrestricted license as a physician assistant in the Commonwealth;

2. Submit Maintain a practice agreement acceptable to the board as prescribed in 18VAC85-50-101. This practice agreement must be approved by the board prior to issuance of prescriptive authority and § 54.1-2952.1 of the Code of Virginia; and

3. Submit evidence of successful passing of the NCCPA exam; and 4. Submit evidence of successful completion of a minimum of 35 hours of acceptable training to the board in pharmacology.

18VAC85-50-140. Approved drugs and devices.

A. The approved drugs and devices which the physician assistant with prescriptive authority may prescribe, administer, or dispense manufacturer's professional samples shall be in accordance with provisions of § 54.1-2952.1 of the Code of Virginia:

B. The physician assistant may prescribe only those categories of drugs and devices included in the practice agreement as submitted for authorization. The supervising physician retains the authority to restrict certain drugs within these approved categories.

C. The physician assistant, pursuant to § 54.1-2952.1 of the Code of Virginia, shall only dispense manufacturer's professional samples or administer controlled substances in good faith for medical or therapeutic purposes within the course of his professional practice.