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, 18VAC85-50-130, 18VAC85-50-150).

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

Public Hearing Information:

December 6, 2012 - 8:30 a.m. - Department of Health Professions, 9960 Mayland Drive, Perimeter Center, Suite 201, Richmond, VA

Public Comment Deadline: January 18, 2013.

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 54.1-2400 of the Code of Virginia provides the Board of Medicine the authority to promulgate regulations to administer the regulatory system. Specific authority for regulation of physician assistant practice is found in §§ 54.1-2951.1 and 54.1-2952 of the Code of Virginia.

Purpose: In its request for amendments, the Virginia Academy of Physician Assistants (VAPA) noted that the regulation currently restricts the practice of a physician with his physician assistant (PA) by mandating the exact number of successive visits each patient may receive from the PA. The rule may negatively impact scheduling of patients and the care and treatment of chronic illnesses. According to the VAPA, it would be preferable for the supervising physician to determine the frequency of review of PA services and the frequency of seeing patients with continuing illnesses, depending on his medical judgment and knowledge of the patient. Since the physician is ultimately responsible for coordinating and managing the care of the patient, amendments to the supervisory responsibilities of a physician will provide appropriate oversight and evaluation to protect the health and safety of patients being jointly treated by PA's and supervising physicians.

Substance: The amendments require the supervising physician to 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 PA/Physician Protocol for the evaluation process.

In the process of considering amendments to the "fourth visit," the board also amended its current regulations for prescriptive authority for PA's to ensure compliance with §§ 54.1-2952 and 54.1-2952.1 of the Code of Virginia, which requires a written agreement setting out the controlled substances (by schedule or class of drugs) the PA is allowed to prescribe and requirements for site visits if the PA practices in a location other than where the supervising physician regularly practices.

Issues: The advantage of the amended regulation is more flexibility in the scheduling of patients with the supervising physician or the PA, while specifying that the physician must be involved with a patient for a continuous illness or see the patient who presents for the same complaint twice in a single episode and has not improved. Greater specificity in the content of a practice agreement with delineation of roles and responsibilities is beneficial to practitioners and patients. There are no disadvantages to the public. 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. The Board of Medicine (Board) proposes to amend its Regulations Governing the Practice of Physician Assistants to eliminate language that requires supervising physicians to see returning patients "not less frequently than every fourth visit for a continuing illness."

Result of Analysis. Benefits likely outweigh costs for implementing these proposed changes.

Estimated Economic Impact. Current regulations require that physicians who supervise physician assistants "see and evaluate" returning patients who are being treated for an ongoing health issue "not less frequently than every fourth visit." The Board believes this rule is too restrictive on physicians and physician assistants and may adversely impact patients, particularly patients with chronic illnesses, who may not be able to as easily schedule doctor's appointments at times that are convenient and at intervals that are conducive to maintaining treatment for their illnesses. The Board proposes to eliminate this requirement and, instead, require that the written practice agreement between physician assistants and their supervising physicians specify when a physician would step in to evaluate a patient. For instance, such an agreement might specify that the physician would reevaluate a patient if his or her symptoms changed or worsened.

This change will benefit physicians and physician assistants who will have more flexibility to plan office hours and patient visits more efficiently. The delineation of duties that will be written into the practice agreements between these parties will likely protect quality of patient care so patients will likely not incur any costs on account of these changes. Patients may, instead, benefit if these changes allow them to more easily schedule appointments.

Businesses and Entities Affected. The Department of Health Professions (DHP) reports that the Board currently regulates 1,781 physician assistants. All of these individuals, as well as their supervisors and patients will be affected by these proposed regulations.

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

Projected Impact on Employment. This proposed regulatory action is unlikely to have any effect on employment in the Commonwealth.

Effects on the Use and Value of Private Property. These proposed regulatory changes are unlikely to affect the use or value of private property in the Commonwealth.

Small Businesses: Costs and Other Effects. No small business is likely to incur any costs on account of this regulatory action.

Small Businesses: Alternative Method that Minimizes Adverse Impact. No small business is likely to incur any 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. 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 Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the 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. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

Agency's Response to Economic Impact Analysis: The Board of Medicine concurs with the analysis of the Department of Planning and Budget for 18VAC85-50, Regulations Governing the Practice of Physician Assistants, relating to practice agreements.

Summary:

The amendments (i) change the requirement for the physician to see a patient not less frequently than every fourth visit for a continuing illness by allowing the physician and his assistant to determine the evaluation process and (ii) amend the regulations for consistency and clarity.

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:

"Committee" means the Advisory Committee on Physician Assistants as specified in § 54.1-2950.1of the Code of Virginia.

"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.

"Protocol" "Practice agreement" means a set of directions written agreement developed by the supervising physician that defines the supervisory relationship between the physician assistant and the physician 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.

Part IV
Practice Requirements

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

A. Prior to initiation of practice, a physician assistant and his supervising physician shall submit a written protocol practice agreement which spells out the roles and functions of the assistant. Any such protocol 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. The protocol 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.

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 protocol practice agreement shall include those:

1. Those schedules and categories of drugs and devices that are within the scope of practice and proficiency of the supervising physician.; and

2. 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.

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

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

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

The supervising physician shall:

1. See and evaluate any patient who presents the same complaint twice in a single episode of care and has failed to improve significantly. Such physician involvement shall occur not less frequently than every fourth visit for a continuing illness 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 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 above 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 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.

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 protocol 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 protocol 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. If, due to illness, vacation, or unexpected absence, the supervising physician is unable to supervise the activities of his assistant, such supervising physician may temporarily delegate the responsibility to another doctor of medicine, osteopathy osteopathic medicine, or podiatry. The supervising physician so delegating his responsibility shall report such arrangement for coverage, with the reason therefor, to the board office in writing, subject to the following provisions:

1. For planned absence, such notification shall be received at the board office at least one month prior to the supervising physician's absence;

2. For sudden illness or other unexpected absence, the board office shall be notified as promptly as possible, but in no event later than one week; and

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

C. 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 protocol practice agreement to act as supervising physician for that assistant. The board shall make available appropriate forms for physicians to join the protocol practice agreement for an assistant employed by an institution.

2. Any such protocol 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. 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 a protocol practice agreement acceptable to the board prescribed in 18VAC85-50-101. This protocol practice agreement must be approved by the board prior to issuance of prescriptive authority;

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.

18VAC85-50-150. Protocol regarding prescriptive authority. (Repealed.)

A. A physician assistant with prescriptive authority may prescribe only within the scope of the written protocol as prescribed in 18VAC85-50-101.

B. A new protocol must be submitted with the initial application for prescriptive authority and with the application for each biennial renewal, if there have been any changes in supervision, authorization or scope of practice.