Title of Regulation: 18VAC85-20. Regulations Governing the Practice of Medicine, Osteopathic Medicine, Podiatry, and Chiropractic (amending 18VAC85-20-90).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: July 1, 2015.

Effective Date: July 16, 2015.

Agency Contact: William L. Harp, M.D., Executive Director, Board of Medicine, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4621, 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.

Purpose: The purpose of the amended regulation is to provide appropriate access to treatment for persons suffering from obesity and its accompanying health risks. A physician assistant under the supervision of a physician or a nurse practitioner who has a collaborative arrangement with a patient care team physician should be able to perform the physical examination, order the tests, and follow a patient for whom weight loss drugs are being prescribed. Currently, regulations specify those functions may only be performed by the physician. The goal of the amended regulation is to clarify that the protocol or standard of care set forth in 18VAC85-20-90 is essential for appropriate treatment with weight loss drugs, but that a nurse practitioner or physician assistant may be authorized by a practice agreement with a collaborating or supervising physician to treat such a patient. 18VAC85-20-90 was originally adopted in response to serious complications from the overprescribing of weight loss drugs and the failure of some physician practices to properly screen and follow patients. While the Board of Medicine believes care of those patients, including prescribing, is within the scope of practice of nurse practitioners and physician assistants, the protocol or standard of care must be applied to their practice as well as the physicians with whom they have a practice agreement to protect the health and safety of patients.

Rational for Using Fast-Track Process: Since this action does not expand the scope of practice of nurse practitioners or physician assistants, it will not be controversial. The amendment clarifies the standard of care for all types of practitioners who are treating and prescribing for weight loss.

Substance: Subsection C is added to 18VAC85-20-90 to provide 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, as specified in subsection B of this section."

Issues: The primary advantage to the public is expanded access to weight loss treatment that includes prescribing of controlled substances by physician assistants and nurse practitioners. By tying such practice to the standard of care set forth in regulations for the physician with whom the physician assistant practices or with whom the nurse practitioner has a collaborative agreement, patients are protected against some of the potentially serious risks associated with such drugs. 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. The Board of Medicine (Board) proposes to specify that nurse practitioners (NPs) and physician assistants (PAs) are allowed to treat obesity, including prescribing appropriate Schedule III through VI drugs, so long as they are supervised by, or collaborating with, a physician and so long as such treatment is specifically authorized in the NP's or PA's practice agreement.

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

Estimated Economic Impact. Current Board regulation requires that individuals seeking treatment for obesity must see a physician even though treating patients with obesity and prescribing Schedule III and IV drugs for weight loss are within the scope of practice for NPs (and are with the competency of PAs). In order to allow both NPs and PAs to treat obesity, inclusive of prescribing drugs that they are competent to prescribe, the Board now proposes to amend this regulation to allow this. Under the proposed regulation, both PNs and PAs will be allowed to treat obesity, including prescribing appropriate Schedule III through VI drugs, so long as they are supervised by, or collaborating with, a physician and so long as such treatment is specifically authorized in the NP's or PA's practice agreement.

This change will likely benefit PAs and NPs as it will allow them to treat all conditions that they are competent to treat. This change will also likely benefit physicians who employ PAs and NPs as it will allow them to delegate treatment of obesity patients so that they can better budget their time and help more patients. Obesity patients will benefit, also, because they are likely to find it easier to get appointments and treatment from an expanded pool of professionals who are authorized to treat them.

Businesses and Entities Affected. Because the Board does not license physicians by specialty, Board staff does not have an estimate of how many individuals this regulatory change will affect. Generally, it will affect all PAs and NPs who work with doctors that offer obesity treatment.

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

Projected Impact on Employment. This proposed regulation will increase the number of individuals who are authorized to treat obesity and so will increase employment geared toward this treatment.

Effects on the Use and Value of Private Property. If this proposed regulation increases the number of patients that can be seen for obesity treatment, the value of supervising physician's practices may increase.

Small Businesses: Costs and Other Effects. No small business is likely to incur any costs on account of the proposed regulation.

Small Businesses: Alternative Method that Minimizes Adverse Impact. No small business is likely to incur any costs on account of the proposed regulation.

Real Estate Development Costs. This proposed regulation is unlikely to affect real estate development costs.

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 17 (2014). 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 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.

Agency Response to Economic Impact Analysis: The Board of Medicine concurs with the analysis of the Department of Planning and Budget for amendments to 18VAC85-20 relating to prescribing for weight loss by nurse practitioners and physician assistants.

Summary:

The proposed amendment specifies that nurse practitioners and physician assistants are allowed to perform the physical examinations, review tests, and prescribe appropriate Schedules III through VI drugs in the treatment of obesity, so long as they are supervised by or collaborating with a physician and such treatment is specifically authorized in the nurse practitioner's or physician assistant's practice agreement.

18VAC85-20-90. 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;

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 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, as specified in subsection B of this section.