Title of Regulation: 18VAC85-50. Regulations Governing the Practice of Physician Assistants (amending 18VAC85-50-10, 18VAC85-50-35, 18VAC85-50-40, 18VAC85-50-57, 18VAC85-50-101, 18VAC85-50-110, 18VAC85-50-115, 18VAC85-50-117, 18VAC85-50-140, 18VAC85-50-160, 18VAC85-50-181).

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

Public Hearing Information:

October 8, 2020 - 1:05 p.m. - Perimeter Center, 9960 Mayland Drive, Suite 201, Richmond, VA 23233-1463

Public Comment Deadline: October 30, 2020.

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.

Purpose: The purpose of this regulatory action is compliance with statutory changes delineating the practice of a physician assistant. The amendments are consistent with the requirement for a practice agreement between or among the parties and the responsibility of the patient care team physician or podiatrist for the health, safety, and welfare of patients who receive care.

Substance: Amendments are adopted to comply with changes to the Code of Virginia by Chapters 92 and 137 of the 2019 Acts of Assembly, which eliminated practice by a physician assistant under the supervision of a physician or podiatrist and redefined the relationship as one of practice in collaboration and consultation with a patient care team physician or podiatrist.

Issues: There are no advantages or disadvantages to the public apart from those in the statutory language in Chapter 29 (§ 54.1-2900 et seq.) of Title 54.1. The changes do not substantially alter the practice model for physician assistants and physicians as they are currently employed.

There are no particular advantages or disadvantages to the agency.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Medicine (Board) proposes to revise the regulation to reflect new legislation that revised the practice relationship between a physician assistant and a physician or a podiatrist and to repeal an obsolete fee.

Background. This action results from Chapters 92¹ and 137² of the 2019 Acts of Assembly that changed how physician assistants practice, from practicing under the supervision of a physician or podiatrist to practicing as part of a patient care team. The legislation established "a patient care team model" where the focus of the relationship is on collaboration and consultation rather than supervision. In the new model, the role of the patient care team physician or podiatrist is to provide management and leadership to a physician assistant in the care of patients as part of a patient care team.

Estimated Benefits and Costs. According to the Department of Health Professions (DHP), the patient care team model affords more discretion to the physician assistants as the focus of the relationship has shifted from supervision to collaboration and consultation under the new legislation. Otherwise, the change does not substantially alter the practice model for physician assistants and physicians as they are currently employed. Since there are no significant differences in the way physician assistants and doctors practice, the main benefit of this change is clarity and consistency of the regulation with the statute.

The Board also proposes to repeal obsolete language requiring a $15 fee for the review and approval of new protocols that are submitted following initial licensure. This fee has not been enforced in practice following the passage of Chapter 450 of the 2016 Acts of Assembly³ that required only "Evidence of a practice agreement shall be maintained by the physician assistant and provided to the Board upon request, " but it has been inadvertently left in the regulatory text since then. The main benefit of this change is the removal of inaccurate language from the regulatory text.

Businesses and Other Entities Affected. The proposed amendments affect physicians and physician assistants entering into professional collaboration and a consultation relationship. There are 38,947 doctors of medicine and surgery, 3,834 doctors of osteopathic medicine, 553 doctors of podiatry, and 4,224 physician assistants. None of these entities appears to be disproportionately affected.

Small Businesses⁴ Affected. The proposed amendments do not appear to adversely affect small businesses.

Localities⁵ Affected.⁶ The proposed amendments potentially affect physicians and physician assistants entering into professional collaboration and consultation relationship in all 132 localities. The proposed amendments do not introduce costs for local governments. Accordingly, no additional funds would be required.

Projected Impact on Employment. The proposed amendments do not appear to affect total employment.

Effects on the Use and Value of Private Property. The proposed amendments do not affect real estate development costs.

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¹http://lis.virginia.gov/cgi-bin/legp604.exe?191+ful+CHAP0092.

²http://lis.virginia.gov/cgi-bin/legp604.exe?191+ful+CHAP0137.

³http://lis.virginia.gov/cgi-bin/legp604.exe?161+ful+CHAP0450.

⁴Pursuant 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. "

⁵"Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

⁶§ 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

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

Summary:

Pursuant to Chapters 92 and 137 of the 2019 Acts of Assembly, the amendments replace practice by a physician assistant under the supervision of a physician or a podiatrist with practice in collaboration and consultation with a patient care team physician or patient care team podiatrist.

Part I
General Provisions

18VAC85-50-10. Definitions.

A. The following words and terms shall have the meanings ascribed to them in § 54.1-2900 of the Code of Virginia:

"Board."

"Collaboration."

"Consultation."

"Patient care team physician."

"Patient care team podiatrist."

"Physician assistant."

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

"Group practice" means the practice of a group of two or more doctors of medicine, osteopathy, or podiatry licensed by the board who practice as a partnership or professional corporation.

"Institution" means a hospital, nursing home or other health care facility, community health center, public health center, industrial medicine or corporation clinic, a medical service facility, student health center, or other setting approved by the board.

"NCCPA" means the National Commission on Certification of Physician Assistants.

"Practice agreement" means a written or electronic agreement developed by the supervising patient care team physician or podiatrist and the physician assistant that defines the supervisory relationship between the physician assistant and the physician or podiatrist, the prescriptive authority of the physician assistant, and the circumstances under which the physician or podiatrist will see and evaluate the patient.

"Supervision" means the supervising physician has on-going, regular communication with the physician assistant on the care and treatment of patients, is easily available, and can be physically present or accessible for consultation with the physician assistant within one hour.

18VAC85-50-35. Fees.

Unless otherwise provided, the following fees shall not be refundable:

1. The initial application fee for a license, payable at the time application is filed, shall be $130.

2. The biennial fee for renewal of an active license shall be $135 and for renewal of an inactive license shall be $70, payable in each odd-numbered year in the birth month of the licensee. For 2021, the fee for renewal of an active license shall be $108, and the fee for renewal of an inactive license shall be $54.

3. The additional fee for late renewal of licensure within one renewal cycle shall be $50.

4. A restricted volunteer license shall expire 12 months from the date of issuance and may be renewed without charge by receipt of a renewal application that verifies that the physician assistant continues to comply with provisions of § 54.1-2951.3 of the Code of Virginia.

5. The fee for review and approval of a new protocol submitted following initial licensure shall be $15.

6. 5. The fee for reinstatement of a license pursuant to § 54.1-2408.2 of the Code of Virginia shall be $2,000.

7. 6. The fee for a duplicate license shall be $5.00, and the fee for a duplicate wall certificate shall be $15.

8. 7. The handling fee for a returned check or a dishonored credit card or debit card shall be $50.

9. 8. The fee for a letter of good standing or verification to another jurisdiction shall be $10.

10. 9. The fee for an application or for the biennial renewal of a restricted volunteer license shall be $35, due in the licensee's birth month. An additional fee for late renewal of licensure shall be $15 for each renewal cycle.

Part II
Requirements for Practice as a Physician's Assistant

18VAC85-50-40. General requirements.

A. No person shall practice as a physician assistant in the Commonwealth of Virginia except as provided in this chapter.

B. All services rendered by a physician assistant shall be performed only under the continuous supervision of in accordance with a practice agreement with a doctor of medicine, osteopathy, or podiatry licensed by this board to practice in the Commonwealth.

18VAC85-50-57. Discontinuation of employment.

If for any reason the physician assistant discontinues working in the employment and under the supervision of a licensed practitioner with a patient care team physician or podiatrist, a new practice agreement shall be entered into in order for the physician assistant either to be reemployed by the same practitioner or to accept new employment with another supervising physician patient care team physician or podiatrist.

Part IV
Practice Requirements

18VAC85-50-101. Requirements for a practice agreement.

A. Prior to initiation of practice, a physician assistant and his supervising patient care team physician or podiatrist shall enter into a written or electronic practice agreement that spells out the roles and functions of the assistant and is consistent with provisions of § 54.1-2952 of the Code of Virginia.

1. The supervising patient care team physician or podiatrist shall be a doctor of medicine, osteopathy, or podiatry licensed in the Commonwealth who has accepted responsibility for the supervision of the service that a physician assistant renders.

2. Any such practice agreement shall take into account such factors as the physician assistant's level of competence, the number of patients, the types of illness treated by the physician or podiatrist, the nature of the treatment, special procedures, and the nature of the physician or podiatrist availability in ensuring direct physician or podiatrist involvement at an early stage and regularly thereafter.

3. The practice agreement shall also provide an evaluation process for the physician assistant's performance, including a requirement specifying the time period, proportionate to the acuity of care and practice setting, within which the supervising physician or podiatrist shall review the record of services rendered by the physician assistant.

4. The practice agreement may include requirements for periodic site visits by supervising licensees who supervise and direct the patient care team physician or podiatrist to collaborate and consult with physician assistants who provide services at a location other than where the licensee physician or podiatrist regularly practices.

B. The board may require information regarding the level degree of supervision with which the supervising collaboration and consultation by the patient care team physician plans to supervise the physician assistant for selected tasks or podiatrist. The board may also require the supervising patient care team physician or podiatrist to document the physician assistant's competence in performing such tasks.

C. If the role of the physician assistant includes prescribing drugs and devices, the written practice agreement shall include those schedules and categories of drugs and devices that are within the scope of practice and proficiency of the supervising patient care team physician or podiatrist.

D. If the initial practice agreement did not include prescriptive authority, there shall be an addendum to the practice agreement for prescriptive authority.

E. If there are any changes in supervision consultation and collaboration, authorization, or scope of practice, a revised practice agreement shall be entered into at the time of the change.

18VAC85-50-110. Responsibilities of the supervisor patient care team physician or podiatrist.

The supervising patient care team physician or podiatrist 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 or podiatrist 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 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 supervision with the physician in the room unless, after directly observing the performance of a specific invasive procedure three times or more, the supervising patient care team physician or podiatrist attests on the practice agreement to the competence of the physician assistant to perform the specific procedure without direct observation and supervision.

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

4. Be available at all times to collaborate and consult with the physician assistant.

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 patient care team physician or podiatrist as prescribed in the physician assistant's practice agreement. When a physician assistant is to be supervised by an alternate supervising physician working outside the scope of specialty of the supervising patient care team physician or podiatrist, 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 patient care team physician or podiatrist.

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 patient care team physician or podiatrist shall be a member of the same group, professional corporation, or partnership of any licensee who supervises is the patient care team physician or podiatrist for a physician assistant or shall be a member of the same hospital or commercial enterprise with the supervising patient care team physician or podiatrist. Such alternating supervising physician or podiatrist shall be a physician or podiatrist licensed in the Commonwealth 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 patient care team physician or podiatrist or alternate supervising physician or podiatrist is unable to supervise the activities of his physician assistant, such supervising patient care team physician or podiatrist 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 or podiatrist responsible for that patient has signed the practice agreement to act as supervising patient care team physician or podiatrist for that physician assistant.

2. Any such practice agreement as described in subdivision 1 of this subsection shall delineate the duties which said patient care team physician or podiatrist 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.

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

A physician assistant working under the supervision of a practice agreement with 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.

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. The supervising patient care team physician or podiatrist 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.

18VAC85-50-160. Disclosure.

A. Each prescription for a Schedule II through V drug shall bear the name of the supervising patient care team physician or podiatrist and of the physician assistant.

B. The physician assistant shall disclose to the patient that he is a licensed physician assistant, and also the name, address and telephone number of the supervising patient care team physician or podiatrist. Such disclosure shall either be included on the prescription or be given in writing to the patient.

18VAC85-50-181. Pharmacotherapy for weight loss.

A. A practitioner shall not prescribe amphetamine, Schedule II, for the purpose of weight reduction or control.

B. A practitioner shall not prescribe controlled substances, Schedules III through VI, for the purpose of weight reduction or control in the treatment of obesity, unless the following conditions are met:

1. An appropriate history and physical examination are performed and recorded at the time of initiation of pharmacotherapy for obesity by the prescribing physician, and the physician reviews the results of laboratory work, as indicated, including testing for thyroid function;

2. If the drug to be prescribed could adversely affect cardiac function, the physician shall review the results of an electrocardiogram performed and interpreted within 90 days of initial prescribing for treatment of obesity;

3. A diet and exercise program for weight loss is prescribed and recorded;

4. The patient is seen within the first 30 days following initiation of pharmacotherapy for weight loss, by the prescribing physician or a licensed practitioner with prescriptive authority working under the supervision of the prescribing physician, at which time a recording shall be made of blood pressure, pulse, and any other tests as may be necessary for monitoring potential adverse effects of drug therapy; and

5. The treating physician shall direct the follow-up care, including the intervals for patient visits and the continuation of or any subsequent changes in pharmacotherapy. Continuation of prescribing for treatment of obesity shall occur only if the patient has continued progress toward achieving or maintaining a target weight and has no significant adverse effects from the prescribed program.

C. If specifically authorized in his practice agreement with a supervising patient care team physician, a physician assistant may perform the physical examination, review tests, and prescribe Schedules III through VI controlled substances for treatment of obesity as specified in subsection B of this section.