Title of Regulation: 18VAC85-50. Regulations Governing the Practice of Physician Assistants (adding 18VAC85-50-117).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: January 28, 2015.

Effective Date: February 13, 2015.

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: Chapter 24 (§ 54.1-2400 et seq.) of Title 54.1 of the Code of Virginia establishes the general powers and duties of health regulatory boards including the responsibility to promulgate regulations. Section 54.1-2400 provides that the board has the power to promulgate regulations in accordance with the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) that are reasonable and necessary to administer effectively the regulatory system. Section 54.1-2952 provides that a licensed physician assistant who (i) is working under the supervision of a licensed doctor of medicine or osteopathy specializing in the field of radiology, (ii) has been trained in the proper use of equipment for the purpose of performing radiologic technology procedures consistent with board regulations, and (iii) has successfully completed the exam administered by the American Registry of Radiologic Technologists for physician assistants for the purpose of performing radiologic technology procedures may use fluoroscopy for guidance of diagnostic and therapeutic procedures.

Purpose: The purpose of the regulation is to establish the qualifications of a physician assistant who may use fluoroscopy for guidance of diagnostic and therapeutic procedures under the supervision of a physician specializing in the field of radiology. Fluoroscopy is a radiological procedure that is not within the usual scope of practice of a physician assistant. Therefore, additional education, training and testing are required to ensure minimal competency to perform the procedure. The goal of the amended regulation is to set qualifications that are consistent with those recommended by the national professional bodies for both radiologic technologists and physician assistants.

Fluoroscopy is a radiologic procedure that emits high levels of ionizing radiation and is used for diagnostic and therapeutic purposes. Performed improperly, flurorscopy can harm a patient or cause a misdiagnosis that can harm a patient. Since fluoroscopy is typically outside the scope of practice for physician assistants and not covered in their prelicensure educational programs and examinations, additional qualifications must be established to ensure minimal competency to perform the procedure with safety and effectiveness to protect the public health, welfare, and safety.

Rationale for Using Fast-Track Process: An emergency regulation became effective on November 12, 2013, and a Notice of Intended Regulatory Action was published for the replacement of the emergency. During the 30-day comment period, there was no comment, and there have been no issues reported by providers.

Substance: 18VAC85-50-117 sets out qualifications by which a physician assistant working under the supervision of a licensed doctor of medicine or osteopathy specializing in the field of radiology is authorized to use fluoroscopy for guidance of diagnostic and therapeutic procedures provided such activity is specified in his protocol. Those qualifications are (i) completion of at least 40 hours of structured didactic educational instruction and at least 40 hours of supervised clinical experience as set forth in the Fluoroscopy Educational Framework for the Physician Assistant created by the American Academy of Physician Assistants and the American Registry of Radiologic Technologists (ARRT) and (ii) successful passage of the ARRT Fluoroscopy Examination.

Issues: The primary advantage is a very modest expansion of practice by mid-level providers, specifically physician assistants working under the supervision of radiologists. There are no disadvantages; there is adequate education and training to assure minimal competency for safe and effective practice. There are no advantages or disadvantages to the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapter 81 of the 2012 Acts of the Assembly, the Board of Medicine (Board) proposes to amend its Regulations Governing the Practice of Physician Assistants so that physician assistants who have completed specified training may use fluoroscopy.¹ This proposed amendment will replace identical language promulgated under emergency regulation provisions that will expire May 11, 2015.

Result of Analysis. Benefits likely outweigh costs for this proposed regulatory change.

Estimated Economic Impact. Prior to a legislative change in 2012, only radiologists and licensed radiological technicians were authorized to use fluoroscopy. In 2012, the General Assembly passed a bill which extended the practice of physician assistants so that they, too, could use fluoroscopy so long as they 1) work under the supervision of a doctor of medicine or osteopathy specializing in the field of radiology, 2) complete Board specified training and 3) successfully complete the fluoroscopy exam administered by the American Registry of Radiologic Technologists (ARRT). The Board proposes to require physician assistants to complete at least 40 hours of education and at least 40 hours of supervised clinical experience.²

Physician assistants who choose to pursue expanding their scope of practice to include the use of fluoroscopy will incur costs for completing the required training and for taking the fluoroscopy exam. The fee for the exam is $175; currently, there does not seem to be an estimate of what training will cost. In any case, physician assistants are unlikely to incur these costs if they do not think the benefits that they expect will accrue to them (in the form of greater job opportunities and/or higher salaries) justify the expense. If a significant number of physician assistants choose to become qualified to use fluoroscopy, the maximum capacity of fluoroscopy services may increase which might, in turn, lower the cost of those services.

Businesses and Entities Affected. Board staff reports that the Board currently licenses 2,774 physician assistants. Board staff does not know how many of these physician assistants currently work for radiologists or how many might choose to become qualified to use fluoroscopy. It is likely that the number of affected entities would be a small subset of the total number of physician assistants.

Localities Particularly Affected. No locality will be particularly affected by this proposed regulatory action.

Projected Impact on Employment. If a significant number of physician assistants choose to become qualified to use fluoroscopy, the maximum capacity of fluoroscopy services may increase which might, in turn, lower the cost of those services. If this happens, the quantity of fluoroscopy services demanded may increase and employment in jobs that use fluoroscopy may increase.

Effects on the Use and Value of Private Property. This regulatory action may increase the value of a physician assistant's license if becoming qualified to use fluoroscopy increases the wage that qualified individuals can command.

Small Businesses: Costs and Other Effects. No small businesses will incur costs on account of this regulatory action.

Small Businesses: Alternative Method that Minimizes Adverse Impact. No small businesses will incur costs on account of this regulatory action.

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

Legal Mandate.

General: 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 Code of Virginia and Executive Order Number 14 (2010). Section 2.2-4007.04 requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the report should include but not be limited to:

• the projected number of businesses or other entities to whom the proposed 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.

Small Businesses: If the proposed regulation will have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include:

• an identification and estimate of the number of small businesses subject to the proposed regulation,

• the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents,

• a statement of the probable effect of the proposed regulation on affected small businesses, and

• a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation.

Additionally, pursuant to § 2.2-4007.1, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules (JCAR) is notified at the time the proposed regulation is submitted to the Virginia Register of Regulations for publication. This analysis shall represent DPB's best estimate for the purposes of public review and comment on the proposed regulation.

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¹ Fluoroscopy, according to emedicine.medscape.com, is “a technique that employs x-rays to generate real-time still images or video of a patient's body. It is a commonly used medical technique that helps physicians with a wide variety of diagnostic and interventional procedures”.

2 The Board specified in the emergency regulation, and specifies in this action, that physician assistants who wish to expand their scope of practice to include the use of fluoroscopy must complete education and supervised practice as set forth in the Fluoroscopy Education Framework for the Physician Assistant by the American Academy of Physician Assistants (AAPA) and the American Society of Radiological Technologists (ASRT).

Agency's Response to Economic Impact Analysis: The Board of Medicine concurs with the economic impact analysis on 18VAC85-50.

Summary:

The regulation establishes the qualifications of a physician assistant who may use fluoroscopy for guidance of diagnostic and therapeutic procedures under the supervision of a licensed doctor of medicine or osteopathy specializing in the field of radiology. The additional education, training, and testing is consistent with the qualifications recommended by the American Academy of Physician Assistants and the American Society of Radiologic Technologists.

18VAC85-50-117. Authorization to use fluoroscopy.

A physician assistant working under the supervision of a licensed doctor of medicine or osteopathy specializing in the field of radiology is authorized to use fluoroscopy for guidance of diagnostic and therapeutic procedures provided such activity is specified in his protocol and he has met the following qualifications:

1. Completion of at least 40 hours of structured didactic educational instruction and at least 40 hours of supervised clinical experience as set forth in the Fluoroscopy Educational Framework for the Physician Assistant created by the American Academy of Physician Assistants (AAPA) and the American Society of Radiologic Technologists (ASRT); and

2. Successful passage of the American Registry of Radiologic Technologists (ARRT) Fluoroscopy Examination.

DOCUMENTS INCORPORATED BY REFERENCE (18VAC85-50)

Fluoroscopy Educational Framework for the Physician Assistant, December 2009, American Academy of Physician Assistants, 950 North Washington Street, Alexandria, VA 22314 and the American Society of Radiologic Technologists, 15000 Central Avenue, SE, Albuquerque, NM 87123