Title of Regulation: 18VAC85-50. Regulations Governing the Practice of Physician Assistants (amending 18VAC85-50-160).

Statutory Authority: §§ 54.1-2400 and 54.1-2952.1 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: December 30, 2015.

Effective Date: January 15, 2016.

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 that are reasonable and necessary to administer effectively the regulatory system. Section 54.1-2952.1 of the Code of Virginia authorizes the Board of Medicine, in consultation with the Board of Pharmacy, to promulgate regulations governing the prescriptive authority of physician assistants.

Purpose: The purpose of the amendment is to modify a regulation that is considered burdensome by physician assistants. Facilitating prescribing practice by physician assistants, under the supervision of a physician, will enhance efficiency and access to patient care. Since disclosures about the supervising physician and the licensure of the physician assistant remain in regulation, the amendment to the regulation will not lessen protection for the health and safety of the patient.

Rationale for Using Fast-Track Process: There is no controversy in the adoption of this amendment; it is recommended by physician assistants and the supervising physicians with whom they work.

Substance: The amended regulation will eliminate the requirement for the name of the supervising physician on a prescription written by a physician assistant if the assistant is writing a prescription for a Schedule VI drug. The physician's name on the prescription will continue to be required if the assistant is writing a prescription for Schedule II through V drugs. Amendments also will clarify how the physician assistant can comply with the disclosure requirement specified in § 54.1-2952.1 of the Code of Virginia.

Issues: The primary advantage to the public is facilitation of prescribing by physician assistants for greater efficiency and access. There are no disadvantages to the public. 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. As a result of a recommendation from the Advisory Board on Physician Assistants, the Board of Medicine (Board) proposes to eliminate the requirement for the signature of a supervising physician or podiatrist on prescriptions for Schedule VI drugs written by physician assistants.

Result of Analysis. There is insufficient information to ascertain if benefits will outweigh costs for this regulatory action.

Estimated Economic Impact. Current law requires that physician assistants practice under a written supervisory agreement with a licensed physician or podiatrist "which provides for the direction and supervision by the licensee of the prescriptive practices of the assistant. Such agreement must contain the controlled substances that the physician assistant is or is not authorized to prescribe and may restrict such prescriptive authority as deemed appropriate by the physician or podiatrist providing direction and supervision." As part of that supervision, physician assistants are required to have their supervising physician's or podiatrist's name on all prescriptions that they write whatever the Schedule the prescribed drugs might be in. In February of 2015, the Board considered a recommendation from the Advisory Board on Physician Assistants to eliminate the requirement that a supervising physician's or podiatrist's name be on prescriptions for all Schedule drugs (Schedules II through VI) written by physician assistants as this requirement was seen as unnecessarily burdensome. The Board decided at its meeting on June 18, 2015, to eliminate the requirement for the signature of a supervising physician or podiatrist on prescriptions for Schedule VI drugs but to retain that requirement for prescriptions of Schedule II through V drugs.

Board staff reports that the Board chose to amend this regulation in the way they did because the current system for electronic prescriptions used in the Commonwealth only has a place for two names (the prescribing physician assistant and the supervising physician or podiatrist) on prescriptions for Schedule II through V drugs that fall under the federal Controlled Substances Act. Board staff reports that this change will make it easier for physician assistants to write electronic prescriptions for Schedule VI drugs which are not controlled under federal law but are controlled under Virginia Code. To the extent that physician assistants currently write paper prescriptions for Schedule VI drugs when an electronic prescription sent directly to the pharmacy would allow the patient to avoid spending time and gas to physically pick up their prescription, this change will likely benefit both physician assistants and patients.

Schedule VI drugs include topical anesthetics, and topical and oral anti-allergy drugs (including antihistamines and mast cell stabilizers), anti-fungals, anti-glaucoma drugs, anti-infective drugs (including antibiotics and antivirals) and anti-inflammatory drugs (including steroids like prednisone and Solu-Medrol). While these drugs are not addictive or as potentially dangerous as drugs in Schedules II through V, they can still be dangerous if prescribed incorrectly or for too long. Steroids, for instance, can induce Cushing's Syndrome in individuals who take them long term. Although Board staff reports that physician assistants have other requirements to disclose the name of their supervising physician that will likely protect patient health, removing the supervising physician's or podiatrist's name from Schedule VI drug prescriptions may decrease the ability of outside entities like pharmacists, who are not privy to information about the physician assistant's supervisor outside of the information explicitly contained on a prescription, to report potential contra-indications and problematic prescriptive practices directly to that supervisor. Without knowing either the magnitude of time savings for physician assistants and patients due to easier electronic prescribing or the potential magnitude of any possible harm that may arise from this change, it is not possible to say if benefits will outweigh costs for this regulatory change.

Businesses and Entities Affected. This regulatory change will affect all physician assistants as well as the patients who see them. Board staff reports that there are currently 3,058 individuals who are licensed as physician assistants in the Commonwealth.

Localities Particularly Affected. This proposed change will not particularly affect any locality in the Commonwealth.

Projected Impact on Employment. This proposed change is unlikely to impact employment in the Commonwealth.

Effects on the Use and Value of Private Property. This proposed change will likely have no impact on the use or value of private property.

Real Estate Development Costs. This proposed change will likely 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. No small businesses will incur costs on account of this regulatory change.

Alternative Method that Minimizes Adverse Impact. No small businesses will incur costs on account of this regulatory change.

Adverse Impacts:

Businesses: This proposed change is unlikely to adversely impact any business in the Commonwealth.

Localities: This proposed change is unlikely to adversely impact localities.

Other Entities: This proposed change may adversely affect patients prescribed Schedule VI drugs if pharmacists are less likely or able to contact supervising physicians when problems with those prescriptions arise and contacting the prescribing physician assistant does not yield corrective action.

Agency's Response to Economic Impact Analysis: In the adoption of a fast-track regulation, the Board of Medicine does not concur with the statement of the Department of Planning and Budget that "removing the supervising physician's or podiatrist's name from Schedule VI drug prescriptions may decrease the ability of outside entities like pharmacists, who are not privy to information about the physician assistant's supervisor outside of the information explicitly contained on a prescription, to report potential contra-indications and problematic prescriptive practices directly to that supervisor." Pharmacists will have access to that information through the national provider number on each prescription. Additionally, nurse practitioners are not required to list the physician with whom they have a practice agreement on any prescription in Schedules II through VI.

Summary:

The amendments (i) eliminate the requirement for the supervising physician's name to appear on a prescription written by a physician assistant for a Schedule VI drug and (ii) and clarify how a physician assistant may comply with the requirement to disclose to a patient that he is a licensed physician assistant.

18VAC85-50-160. Disclosure.

A. Each prescription for a Schedule II through V drug shall bear the name of the supervising physician 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 physician. Such disclosure may shall either be included on the prescription pad or may be given in writing to the patient.