Title of Regulation: 18VAC85-110. Regulations Governing the Practice of Licensed Acupuncturists (amending 18VAC85-110-80, 18VAC85-110-180).

Statutory Authority: §§ 54.1-2400 and 54.1-2956.9 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: July 24, 2019.

Effective Date: August 8, 2019.

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 amendments protect the health and safety of patients who received acupuncture treatments from a licensed acupuncturist. The regulatory changes are consistent with the principle that regulations should be clearly written and easily understandable.

Rationale for Using Fast-Track Rulemaking Process: As required by Executive Order 14 (2018), the Board of Medicine conducted a periodic review of 18VAC85-110, Regulations Governing the Practice of Licensed Acupuncturists. The amendments are clarifying and intended for consistency with current practice. There are no substantive changes, so the amendments are not expected to be controversial.

Substance: Pursuant to its periodic review of 18VAC85-110, the board adopted amendments to update the name of a required examination and to the use the more inclusive term of "dietary supplements" to include herbs and herbal supplements that acupuncturists are allowed to use and recommend.

Issues: There are no substantive changes to the regulation, so there are no real advantages or disadvantages to the public. The amendments are technical and clarifying. There are no advantages or disadvantages to the agency or the Commonwealth.

Small Business Impact Review Report of Findings: This fast-track regulatory action serves as the report of the findings of the regulatory review pursuant to § 2.2-4007.1 of the Code of Virginia.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to a periodic review,¹ the Board of Medicine (Board) proposes to use "dietary supplements" in lieu of "vitamins, minerals or food supplements" and update the name of the examination required for licensure.

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

Estimated Economic Impact. The Board is proposing to replace "vitamins, minerals or food supplements" acupuncturists are allowed to recommend to their patients with "dietary supplements." According to the Department of Health Professions (DHP), the term "dietary supplements" is used by the Food and Drug Administration (FDA) and includes herbs and herb supplements in addition to vitamins and minerals. The currently used term "food supplements" is interpreted by DHP to include herbs and herb supplements. Consequently, this proposed change will have no impact on what acupuncturists are allowed to recommend. Thus, no significant economic impact is expected from this change beyond improving the consistency between the terms used by FDA and the Board.

The Board also proposes to update the name for the Point Location Examination which used to be referred to as Practical Examination of Point Location Skills. Similarly, this particular change is not expected to create any significant impact other than improving the accuracy of the regulatory language.

Businesses and Entities Affected. The proposed amendments pertain to 529 licensed acupuncturists in the Commonwealth.

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

Projected Impact on Employment. The proposed amendments would not affect employment.

Effects on the Use and Value of Private Property. The proposed amendments would not affect the use and value of private property.

Real Estate Development Costs. The proposed amendments would 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 would not have costs or other effects on small businesses.

Alternative Method that Minimizes Adverse Impact. The proposed amendments would not impose adverse impacts on small businesses.

Adverse Impacts:

Businesses. The proposed amendments would not impose adverse impacts on businesses.

Localities. The proposed amendments would not adversely affect localities.

Other Entities. The proposed amendments would not adversely affect other entities.

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¹http://townhall.virginia.gov/L/ViewPReview.cfm?PRid=1652

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

Summary:

The amendments update the name of a required examination and use the more inclusive term "dietary supplements" to include herbs and herbal supplements that acupuncturists are allowed to use and recommend.

18VAC85-110-80. Examination requirements for licensure.

The examination requirements for licensure shall consist of:

1. Passing the NCCAOM comprehensive written examination, resulting in current, active certification by the NCCAOM at the time the application is filed with the board;

2. Passing the Practical Examination of Point Location Skills (PEPLS) test Examination; and

3. Completing the CNT course as administered by the CCAOM.

18VAC85-110-180. Vitamins, minerals and food Dietary supplements.

A. The recommendation or direction for the use of vitamins, minerals or food dietary supplements and the rationale for that recommendation shall be documented by the practitioner. The recommendation or direction shall be based upon a reasonable expectation that such use will result in a favorable patient outcome, including preventive practices, and that a greater benefit will be achieved than that which can be expected without such use.

B. Vitamins, minerals, or food Dietary supplements, or a used singly or in combination of the three, shall not be sold, dispensed, recommended, prescribed, or suggested in doses that would be contraindicated based on the individual patient's overall medical condition and medications.

C. The practitioner shall conform to the standards of his particular branch of the healing arts in the therapeutic application of vitamins, minerals or food dietary supplement therapy.