Title of Regulation: 18VAC85-170. Regulations Governing the Practice of Genetic Counselors (amending 18VAC85-170-60).

Statutory Authority: §§ 54.1-2400 and 54.1-2957.18 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: January 23, 2019.

Effective Date: February 10, 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. Section 54.1-2957.19 of the Code of Virginia specifically relates to licensure of genetic counselors.

Purpose: The purpose of the regulatory action is clarity and consistency in interpretation of the law and regulation related to issuance of temporary licenses in genetic counseling. A person who passes the national examination and receives certification, as required for licensure, no longer has "active candidate status." The regulation, as currently written, appears to terminate a temporary license when active candidate status is terminated, resulting in placing a qualified genetic counselor who is employed and seeing patients in a limbo period between passage of the examination and issuance of a permanent license. The amendment is necessary to ensure continuation of the temporary license until a permanent license is issued, so there is no disruption in patient care. Likewise, the regulation is amended to clarify that failure of the examination results in termination of active candidate status and of the temporary license, so patient health and safety is not at risk by receiving care from an applicant who has not demonstrated minimal competency.

Rationale for Using Fast-Track Rulemaking Process: Upon recommendation of the Advisory Board on Genetic Counseling, the Board of Medicine voted in February 2018 to adopt an amendment by a fast-track rulemaking action. Subsequently, it was decided that § 54.1-2957.19 of the Code of Virginia should be amended, so the regulatory action was not submitted at that time. The advisory board is concerned that the statutory change may not occur in 2019 and has requested that the Board of Medicine proceed with this fast-track rulemaking action.

Substance: The amendment to 18VAC85-170-60 clarifies that if an applicant fails the licensure examination for genetic counseling, the applicant's active candidate status is terminated, and the applicant is no longer eligible for a temporary license. However, an applicant who passes the examination may continue to practice with a temporary license until a permanent license has been issued.

Issues: The advantage to the public is continuation of genetic counseling services without interruption if those services are being provided by a person with a temporary license who passes the examination and has been certified but has not yet received a permanent license issued by the board. There are no disadvantages; if an applicant fails the examination, the applicant can no longer practice with a temporary license.

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 allow continuance of the temporary license status of a genetic counselor applicant when he or she passes the certification exam.

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

Estimated Economic Impact. An individual may be issued a temporary genetic counselor license when he or she is granted active candidate status by the American Board of Genetic Counseling. Under the current regulatory language, a temporary license expires when the active candidate status is terminated, which occurs when the individual takes the certification exam, regardless of success or failure. As a result, the current regulation calls for termination of a temporary license when the candidate successfully passes the certification exam. The Board proposes to amend the language so that the temporary license is terminated only if the candidate fails the exam.

The proposed amendment would prevent a potential interim period for temporary license holders who have met the qualifications for permanent licensing standards, but have yet to be issued such a license by the Board. No individuals have been disadvantaged by the current regulatory language so far because licensing of genetic counselors have just started recently. The proposed change, however, is beneficial in that it would prevent potential disruptions in employment of successful candidates as well as disruptions in care of their patients.

Businesses and Entities Affected. Currently, there are five pending applications for temporary licensure. In addition, Virginia Commonwealth University, the only genetic counseling program in Virginia, graduates approximately eight new genetic counselors per year.

Localities Particularly Affected. The proposed amendment does not affect any particular locality more than others.

Projected Impact on Employment. The proposed regulation should help prevent unnecessary disruptions in employment of successful genetic counselor candidates. Thus, a potential negative impact on employment would be avoided.

Effects on the Use and Value of Private Property. No impact on the use and value of private property is expected.

Real Estate Development Costs. No impact on real estate development costs is expected.

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 amendment does not create costs. In addition, it should not have other effects on small businesses as genetic counselors usually practice in large medical institutions/hospital systems.

Alternative Method that Minimizes Adverse Impact. The proposed amendment does not have adverse effects on small businesses.

Adverse Impacts:

Businesses. The proposed amendment should benefit large institutions/hospital systems by preventing a potential disruption in their employment of successful genetic counselor candidates.

Localities. The proposed amendment would not adversely affect localities.

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

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

Summary:

The amendment clarifies that if an applicant fails the licensure examination for genetic counseling, the applicant's active candidate status is terminated and the applicant is no longer eligible for a temporary license. An applicant who passes the examination may continue to practice with a temporary license until a permanent license has been issued.

18VAC85-170-60. Licensure requirements.

A. An applicant for a license to practice as a genetic counselor shall provide documentation of (i) a master's degree from a genetic counseling training program that is accredited by the Accreditation Council of Genetic Counseling and (ii) a current, valid certificate issued by the ABGC or ABMG to practice genetic counseling.

B. Pursuant to § 54.1-2957.19 D of the Code of Virginia, applicants for licensure who do not meet the requirements of subsection A of this section may be issued a license provided they (i) apply for licensure before December 31, 2018; (ii) comply with the board's regulations relating to the NSGC Code of Ethics; (iii) have at least 20 years of documented work experience practicing genetic counseling; (iv) submit two letters of recommendation, one from a genetic counselor and another from a physician; and (v) have completed, within the last five years, 25 hours of continuing education approved by the NSGC or the ABGC. For the purpose of this subsection, the board deems the provisions of Part IV (18VAC85-170-110 et seq.) of this chapter to be consistent with the NSGC Code of Ethics.

C. An applicant for a temporary license shall provide documentation of having been granted the active candidate status by the ABGC. Such license shall expire 12 months from issuance or upon expiration of active candidate status failure of the ABGC certification examination, whichever comes first.