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

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

Public Hearing Information:

September 7, 2018 - 8:30 a.m. - Department of Health Professions, Perimeter Center, 9960 Mayland Drive, Suite 201, Richmond, VA 23233

Public Comment Deadline: September 5, 2018.

Effective Date: September 20, 2018.

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, and §§ 54.1-2952, 54.1-2952.1, and 54.1-2952.2, which provide the Board of Medicine authority to regulate the practice of physician assistants.

Purpose: The purpose of the regulatory action is clarity and consistency in rules relating to supervision of physician assistants and removal of any unnecessary rules that may impede the ability of assistants to practice to the full extent of their training and competency as permitted by law. There are no substantive changes that affect the supervisory role of a physician, and the regulations will continue to protect public health and safety.

Rationale for Using Fast-Track Rulemaking Process: The board initially issued a Notice of Intended Regulatory Action (NOIRA) to begin the regulatory process; the proposed changes identified in the NOIRA were fully supported by the Virginia Academy of Physician Assistants and unanimously approved by members of the advisory board and the full Board of Medicine. Therefore, the board determined to move forward with adoption of a fast-track rulemaking action.

Substance: Relating to the use of supervision, the proposed amendments (i) change the definition of "supervision" by combining the meanings of general and continuous supervision; (ii) eliminate definitions of "direct supervision" and "personal supervision" and move the definitions of "alternative supervising physician" and "supervising physician" to the appropriate places in the chapter; (iii) delete the examples of various levels of supervision that may be spelled out in the practice agreement between the parties; and (iv) change the word "supervising" to "observing" to clarify the responsibility of the physician in attesting to the competency of a physician assistant to perform invasive procedures.

Relating to provisions on pharmacotherapy for weight loss, the amendments add language similar to that in regulations for physicians to read, "If specifically authorized in his practice agreement with a supervising 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."

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 physician assistant'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 1) add a provision in the regulation on pharmacotherapy for weight loss to clarify that a physician assistant can conduct the physical examination, review tests, and prescribe drugs if so authorized in a practice agreement with a supervising physician, and 2) amend supervision language to improve clarity.

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

Estimated Economic Impact. The Regulations Governing the Practice of Medicine, Osteopathic Medicine, Podiatry, and Chiropractic (18VAC85-20) specify that "If specifically authorized in his practice agreement with a supervising or collaborating physician, a physician assistant or nurse practitioner may perform the physical examination, review tests, and prescribe Schedules III through VI controlled substances for treatment of obesity…" Nevertheless, the Advisory Board on Physician Assistants (Advisory Board) has noted that not all pharmacies are filling prescriptions written by physician assistants for weight loss.¹ The Advisory Board stated that "It was thought that adding this [language to the physician assistant regulation] would remove any confusion pharmacists might have regarding physician assistants writing prescriptions for weight loss medications."

Thus, the Board proposes to add (for physician assistants) the above quoted language in the Regulations Governing the Practice of Medicine, Osteopathic Medicine, Podiatry, and Chiropractic to the Regulations Governing the Practice of Physician Assistants. This would be beneficial in that it would help ensure that pharmacists and anyone else who only reads the physician assistant regulation are aware that physician assistants are legally permitted to prescribe drugs in these circumstances and to conduct the other listed activities.

Businesses and Entities Affected. The proposed amendments affect current and future physician assistants in the Commonwealth, and their supervising physicians. There are 3,612 persons who hold a current Virginia license as a physician assistant, each of whom may have multiple supervising physicians.²

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

Projected Impact on Employment. The proposed amendments do not significantly affect employment.

Effects on the Use and Value of Private Property. The proposed amendments do not 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 do not significantly affect costs for small businesses.

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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¹See http://townhall.virginia.gov/L/GetFile.cfm?File=C:\TownHall\docroot\\meeting\26\25460\Minutes_DHP_25460_v2.pdf.

²Data source: Department of Health Professions.

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

Summary:

The amendments (i) simplify and clarify the definitions and usage of various terms for supervision for more consistency with the Code of Virginia and with actual practice of physician assistants and supervising physicians and (ii) add a provision regarding pharmacotherapy for weight loss to clarify that a physician assistant can conduct the physical examination, review tests, and prescribe drugs for treatment of obesity if so authorized in a practice agreement with a supervising physician.

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."

"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 agreement developed by the supervising physician and the physician assistant that defines the supervisory relationship between the physician assistant and the physician, the prescriptive authority of the physician assistant, and the circumstances under which the physician will see and evaluate the patient.

"Supervision" means:

1. "Alternate supervising physician" means a member of the same group or professional corporation or partnership of any licensee, any hospital or any 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.

2. "Direct supervision" means the physician is in the room in which a procedure is being performed.

3. "General supervision" means the supervising physician is easily available and can be physically present or accessible for consultation with the physician assistant within one hour.

4. "Personal supervision" means the supervising physician is within the facility in which the physician's assistant is functioning.

5. "Supervising physician" means the 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.

6. "Continuous supervision" means the supervising physician has on-going, regular communication with the physician assistant on the care and treatment of patients 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.

Part IV
Practice Requirements

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

A. Prior to initiation of practice, a physician assistant and his supervising physician shall enter into a written or electronic practice agreement that spells out the roles and functions of the assistant.

1. The supervising physician 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, the nature of the treatment, special procedures, and the nature of the physician availability in ensuring direct physician 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 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 assistants who provide services at a location other than where the licensee regularly practices.

B. The board may require information regarding the level of supervision, (i.e., "direct," "personal," or "general") with which the supervising physician plans to supervise the physician assistant for selected tasks. The board may also require the supervising physician to document the assistant's competence in performing such tasks.

C. If the role of the assistant includes prescribing for 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 physician.

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, 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.

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 with the physician in the room unless, after directly supervising observing 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 observation and supervision.

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

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 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.

B. C. If, due to illness, vacation, or unexpected absence, the supervising physician or alternate supervising physician is unable to supervise the activities of his 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.

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

1. No 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 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 assistant to perform.

3. The 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 assistant shall also record his findings in appropriate institutional records.

D. 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.

18VAC85-50-181. 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 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.