Title of Regulation: 18VAC85-50. Regulations Governing the Practice of Physician Assistants (amending 18VAC85-50-110).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: June 14, 2017.

Effective Date: June 29, 2017.

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: Section 54.-2400 of the Code of Virginia authorizes the Board of Medicine to promulgate regulations that are reasonable and necessary to administer effectively the regulatory system. The specific Code of Virginia sections relating to licensure and practice of physician assistants are § 54.1-2952 (Supervision of assistants by licensed physician, or podiatrist; services that may be performed by assistants; responsibility of licensee; employment of assistants), § 54.1-2952.1 (Prescription of certain controlled substances and devices by licensed physician assistant), § 54.1-2952.2 (When physician assistant signature accepted), and § 54.1-2953 (Renewal, revocation, suspension and refusal).

Purpose: Chapter 450 of the 2016 Acts of Assembly deletes the requirement for physician assistants (PAs) and their supervising doctors to submit a practice agreement for Board of Medicine approval and the requirement for the practice agreement to include periodic site visits for physician assistants who provide services at a location other than where the physician regularly practices. Given that the practice agreement will no longer be submitted and approved by the board, it is reasonable to delete or modify requirements for submission of other documents relating to the oversight of PAs by physicians. Elimination of documents relating to invasive procedures will make the supervision and practice of PAs somewhat less burdensome. Maintenance of a requirement for a physician to attest to the competency of a PA to perform specific invasive procedures will continue to protect the public health and safety.

Rationale for Using Fast-Track Rulemaking Process: The amendments were unanimously approved by members of the Physician Assistant Advisory Board and the Board of Medicine. The Virginia Academy of Physician Assistants commented on the Notice of Intended Regulatory Action in full support of the amendments. Therefore, the board determined to move forward with adoption of a fast-track rulemaking action.

Substance: 18VAC85-50-110 is amended to eliminate the requirements that a physician provide certification for board approval for the PA to perform certain invasive procedures. Physicians would still be required to directly supervise the performance of a specific procedure at least three times and then attest on the practice agreement that the PA is competent to do the procedure under general supervision; that attestation would become part of the PA's practice agreement and would not need to be submitted and approved by the board.

Issues: There are no advantages or disadvantages to the public. The public continues to be protected by maintaining the requirement for physician oversight and certification of the PA's competency to perform invasive procedures. There are no advantages or disadvantages to the agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Medicine (Board) proposes to eliminate current requirements for submission to the Board and Board approval of a physician's certification that his/her physician assistant (PA) is competent to perform specific invasive procedures¹ without direct supervision.

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

Estimated Economic Impact. The proposed regulation would continue to require that the supervising physician attest to the competency of a PA to perform the specific invasive procedures without direct supervision, but would no longer require that the certification be submitted to and approved by the Board. The certification would be in the practice agreement between the supervising physician and the PA. Eliminating the requirements for submission to the Board and Board approval of the physician's certification would save time and effort and potentially would enable a PA to start work sooner. Given that the supervising physician must still attest to the competency of the PA to perform the specific invasive procedures without direct supervision, the proposed amendment should not affect public health and safety. Thus it should produce a net benefit.

Businesses and Entities Affected. The proposed amendments affect current and future physician assistants in the Commonwealth, and their supervising physicians. There are 3,444 persons who hold a current Virginia license as a physician assistant,² each of whom may have multiple supervising physicians.

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

Projected Impact on Employment. The proposed amendments are unlikely to significantly affect employment.

Effects on the Use and Value of Private Property. The proposed amendments are unlikely to significantly affect the use and value of private property.

Real Estate Development Costs. The proposed amendments do 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 save staff time and potentially enable PAs to start work sooner at small medical practices and other small firms that employ PAs.

Alternative Method that Minimizes Adverse Impact. The proposed amendments do not adversely affect small businesses.

Adverse Impacts:

Businesses. The proposed amendments do not adversely affect businesses.

Localities. The proposed amendments do not adversely affect localities.

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

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¹The applicable invasive procedures are all invasive procedures other than insertion of a nasogastric tube, bladder catheter, needle, or peripheral intravenous catheter, but not a flow-directed catheter, and minor suturing, venipuncture, and subcutaneous intramuscular or intravenous injection. These named procedures may already be performed by a PA under general supervision.

²Data source: Department of Health Professions.

Agency's Response to Economic Impact Analysis: The Board of Medicine concurs with the economic impact analysis.

Summary:

The amendments require that a supervising physician attest on the practice agreement to the competence of the physician assistant to perform certain invasive procedures without direct supervision and eliminate the requirement that written certification of competence be submitted to the Board of Medicine for approval.

18VAC85-50-110. Responsibilities of the supervisor.

The supervising physician shall:

1. Review the clinical course and treatment plan for any patient who presents for the same acute complaint twice in a single episode of care and has failed to improve as expected. The supervising physician shall be involved with any patient with a continuing illness as noted in the written or electronic practice agreement for the evaluation process.

2. Be responsible for all invasive procedures.

a. Under general supervision, a physician assistant may insert a nasogastric tube, bladder catheter, needle, or peripheral intravenous catheter, but not a flow-directed catheter, and may perform minor suturing, venipuncture, and subcutaneous intramuscular or intravenous injection.

b. All other invasive procedures not listed in subdivision 2 a of this section must be performed under direct supervision unless, after directly supervising the performance of a specific invasive procedure three times or more, the supervising physician attests on the practice agreement to the competence of the physician assistant to perform the specific procedure without direct supervision by certifying to the board in writing the number of times the specific procedure has been performed and that the physician assistant is competent to perform the specific procedure. After such certification has been accepted and approved by the board, the physician assistant may perform the procedure under general supervision.

3. Be responsible for all prescriptions issued by the assistant and attest to the competence of the assistant to prescribe drugs and devices.