TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF MEDICINE

Fast-Track Regulation

Title of Regulation: 18VAC85-170. Regulations Governing the Practice of Genetic Counselors (amending 18VAC85-170-10, 18VAC85-170-100, 18VAC85-170-110, 18VAC85-170-140, 18VAC85-170-150, 18VAC85-170-160; repealing 18VAC85-170-20, 18VAC85-170-170).

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

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: June 18, 2025.

Effective Date: July 3, 2025.

Agency Contact: Erin Barrett, Director of Legislative and Regulatory Affairs, Department of Health Professions, Perimeter Center, 9960 Mayland Drive, Suite 300, Henrico, VA 23233, telephone (804) 750-3912, FAX (804) 915-0382, or email erin.barrett@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia authorizes the Board of Medicine to promulgate regulations to administer the regulatory system. Section 54.1-2957.19 of the Code of Virginia requires the Board of Medicine to license and regulate genetic counselors.

Purpose: The elimination of redundant provisions and reduction of barriers to licensure generally protect the health, safety, and welfare of citizens by ensuring a sufficient workforce of licensed genetic counselors.

Rationale for Using Fast-Track Rulemaking Process: The impetus for these amendments was the board's 2022 periodic review of this chapter. This action is noncontroversial and appropriate for the fast-track rulemaking process because the changes remove or modify provisions that are redundant of statutory requirements, are not related to the practice of genetic counseling, are outdated, or are otherwise ineffectual.

Substance: The amendments remove redundant statutory provisions or useless directions, including provisions related to (i) outdated definitions; (ii) public participation; (iii) scope of practice provisions that are redundant of statute or nonsensical for genetic counselors based on their scope of practice in § 54.1-2900 of the Code of Virginia, which does not include providing gene therapy or authorizing the use of genetic or diagnostic testing in an emergency setting; (iv) continuing education audit provisions; (v) the sale, closure, or transfer of a practice that are redundant of statutory provisions; (vi) practitioner-patient communication; and (vii) solicitation or remuneration in exchange for referral.

Issues: There are no primary advantages or disadvantages to the public. There are no primary advantages or disadvantages to the agency or the Commonwealth.

Department of Planning and Budget Economic Impact Analysis:

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 19. The analysis presented represents DPB's best estimate of the potential economic impacts as of the date of this analysis.¹

Summary of the Proposed Amendments to Regulation. The Board of Medicine (board) proposes to delete outdated or redundant provisions and clarify some provisions to be consistent with current practice.

Background. As a result of a 2022 periodic review, the board seeks to amend the regulation to remove outdated language and references to the Code of Virginia that are redundant and to update certain provisions so that they accurately reflect current practice.² The most substantive changes are summarized as follows: The definition of "conscience clause" is based on a provision in the Code of Virginia that was repealed in 2021; thus, this definition would be removed. 18VAC85-170-100 D currently states that the board shall periodically conduct random audits. The board reports that it does not have the staff or the ability to conduct such audits and has only performed one or two such audits in the last two decades and seeks to delete this provision. The Department of Health Professions (DHP) noted that the board does investigate and respond to complaints against practitioners, and that removing this provision in the regulation would not increase the risk to the public since the board has not conducted such an audit in many years. 18VAC85-170-150, governing communications with patients, currently contains language copied over from corresponding sections in the regulation for physicians, which does not reflect the work and responsibilities of genetic counselors. For instance, 18VAC85-170-150 A 3 contains requirements for informed consent for genetic procedures with specific requirements for minors and in emergency situations. This language is identical to 18VAC85-20-28 A 3, which governs practitioner-patient communication for physicians, except that 18VAC85-170-150 uses the term "genetic procedure" instead of "surgery" or "invasive procedure".³ However, the board reports that the scope of practice for genetic counselors is very different from that of physicians, so the language should not apply to genetic counselors. The board notes that a genetic counselor's involvement with patients is limited to consultation after examining test results and that the risks involved in such consultation are minimal. In addition, the board reports that a genetic counselor would not be involved in an emergency intervention, so the person who would be subject to obtaining informed consent or being exempted in that situation is the physician.⁴ To the extent that this occurs in practice, the impact of this change would be minimal. However, to the extent that a genetic counselor also advises on the type of tests to administer and the potential consequences of testing, including in emergency interventions, the impact would be greater. The actual extent of the impact cannot be determined based upon available information. The proposed language would still require genetic counselors to obtain documented informed consent in accordance with the policies of the health care entity and consistent with the standard of care. The remaining changes would be to remove references to other chapters of the Virginia Administrative Code or to remove language that is redundant of statute.⁵

Estimated Benefits and Costs: Since the proposed changes would not change the practice of genetic counseling as it is currently practiced, and largely serves to update the regulatory text, neither genetic counselors, nor their employers or clients are likely to incur any benefits or costs other than those benefits that result simply from ensuring the regulatory text is clear and up-to-date. However, to the extent that behavior analysts or the public rely upon the regulation for references to the Code of Virginia, the proposed changes that would remove these references may decrease clarity regarding the requirements applicable to this profession. No information exists with which to determine the extent to which this reliance occurs.

Businesses and Other Entities Affected. DHP reports that there are 593 licensed genetic counselors as of March 31, 2023. The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.⁶ An adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined. Since the proposed amendments would not result in an increase in net costs for any entity, an adverse impact is not indicated.

Small Businesses⁷ Affected.⁸ The proposed amendments would not impact small businesses.

Localities⁹ Affected.¹⁰ The proposed amendments do not disproportionally affect any particular localities or create costs for local governments.

Projected Impact on Employment. The proposed amendments would not affect the employment of genetic counselors, or have any impact on employment in general.

Effects on the Use and Value of Private Property. The proposed amendments are unlikely to affect the value of private property. Real estate development costs would not be affected.

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¹ Section 2.2-4007.04 of the Code of Virginia requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the analysis should include but not be limited to: (1) the projected number of businesses or other entities to whom the proposed regulatory action would apply, (2) the identity of any localities and types of businesses or other entities particularly affected, (3) the projected number of persons and employment positions to be affected, (4) the projected costs to affected businesses or entities to implement or comply with the regulation, and (5) the impact on the use and value of private property.

² See https://townhall.virginia.gov/l/ViewPReview.cfm?PRid=2158.

³ See https://law.lis.virginia.gov/admincode/title18/agency85/chapter20/section28/ for the corresponding language governing physicians in 18VAC85-20.

⁴ Email from DHP dated May 1, 2023. DHP further notes that the language being repealed was initially included in this regulation for consistency with 18VAC85-20 and that although this intent is understandable, in practice this does not translate to usable regulations for many professions regulated by the board. Those professions need individual provisions that reflect the realities of their professions and practices.

⁵ See the Agency Background Document, pp. 7-8 for the specific references that would be removed: https://townhall.virginia.gov/L/GetFile.cfm?File=26\6114\9833\AgencyStatement_DHP_9833_v3.pdf.

⁶ Pursuant to § 2.2-4007.04 D: In the event this economic impact analysis reveals that the proposed regulation would have an adverse economic impact on businesses or would impose a significant adverse economic impact on a locality, business, or entity particularly affected, the Department of Planning and Budget shall advise the Joint Commission on Administrative Rules, the House Committee on Appropriations, and the Senate Committee on Finance. Statute does not define "adverse impact," state whether only Virginia entities should be considered, nor indicate whether an adverse impact results from regulatory requirements mandated by legislation.

⁷ Pursuant to § 2.2-4007.04, 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."

⁸ If the proposed regulatory action may have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include: (1) an identification and estimate of the number of small businesses subject to the proposed regulation, (2) 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, (3) a statement of the probable effect of the proposed regulation on affected small businesses, and (4) 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 of the Code of Virginia, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules shall be notified.

⁹ "Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

¹⁰ Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency Response to Economic Impact Analysis: The Board of Medicine concurs with the economic impact analysis prepared by the Department of Planning and Budget.

Summary:

As a result of a 2022 periodic review, the amendments remove redundant statutory provisions or useless directions, including provisions related to (i) outdated definitions; (ii) public participation; (iii) scope of practice provisions that are redundant of statute or nonsensical for genetic counselors based on their scope of practice in § 54.1-2900 of the Code of Virginia, which does not include providing gene therapy or authorizing the use of genetic or diagnostic testing in an emergency setting; (iv) continuing education audit provisions; (v) the sale, closure, or transfer of a practice that are redundant of statutory provisions; (vi) practitioner-patient communication; and (vii) solicitation or remuneration in exchange for referral.

18VAC85-170-10. Definitions.

A. The following words and terms when used in this chapter shall have the meanings ascribed to them in § 54.1-2900 of the Code of Virginia:

"Board"

"Genetic counselor"

"Practice of genetic counseling"

B. The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"ABGC" means the American Board of Genetic Counseling.

"ABMG" means the American Board of Medical Genetics.

"Active practice" means a minimum of 160 hours of professional practice as a genetic counselor within the 24-month period immediately preceding application for reinstatement or reactivation of licensure. The active practice of genetic counseling may include supervisory, administrative, educational, or consultative activities or responsibilities for the delivery of such services.

"Conscience clause" means the provision of § 54.1-2957.21 of the Code of Virginia.

"NSGC" means the National Society of Genetic Counselors.

18VAC85-170-20. Public participation. (Repealed.)

A separate board regulation, Public Participation Guidelines (18VAC85-11), provides for involvement of the public in the development of all regulations of the Virginia Board of Medicine.

18VAC85-170-100. Continuing education requirements.

A. In order to renew an active license biennially, a licensee shall complete the Continued Competency Activity and Assessment Form that is provided by the board indicating completion of at least 50 contact hours of continuing learning activities as follows:

1. A minimum of 30 of the 50 hours shall be in Category 1 activities approved by the ABGC, the ABMG, or the NSGC and may include in-service training, self-study courses, continuing education courses, or professional workshops.

2. No more than 20 of the 50 hours may be Category 2 activities or professional activity credits, which may include consultation with another counselor or a physician, independent reading or research, authorship, clinical supervision, volunteer leadership in the profession, preparation for a presentation, or other such experiences that promote continued learning.

B. A licensee shall be exempt from the continuing education requirements for the first biennial renewal following the date of initial licensure in Virginia.

C. The licensee shall retain in his records of the completed form with all supporting documentation for a period of four years following the renewal of an active license.

D. The board shall periodically conduct a random audit of its active licensees to determine compliance. The licensees selected for the audit shall provide all supporting documentation within 30 days of receiving notification of the audit.

E. D. Failure to comply with these requirements may subject the licensee to disciplinary action by the board.

F. E. The board may grant an extension of the deadline for continuing competency requirements, for up to one year, for good cause shown upon a written request from the licensee prior to the renewal date.

G. F. The board may grant an exemption for all or part of the requirements for circumstances beyond the control of the licensee, such as temporary disability, mandatory military service, or officially declared disasters.

18VAC85-170-110. General responsibility.

A genetic counselor shall engage in the practice of genetic counseling, as defined in § 54.1-2900 of the Code of Virginia. The practice of genetic counseling may include supervisory, administrative, educational, or consultative activities or responsibilities for the delivery of such services.

18VAC85-170-140. Patient records.

A. Practitioners shall comply with the provisions of § 32.1-127.1:03 of the Code of Virginia related to the confidentiality and disclosure of patient records.

B. Practitioners shall provide patient records to another practitioner or to the patient or his the patient's personal representative in a timely manner in accordance with provisions of § 32.1-127.1:03 of the Code of Virginia.

C. Practitioners shall properly manage and keep timely, accurate, legible, and complete patient records.

D. Practitioners who are employed by a health care institution or other entity in which the individual practitioner does not own or maintain his the individual practitioner's own records shall maintain patient records in accordance with the policies and procedures of the employing entity.

E. Practitioners who are self-employed or employed by an entity in which the individual practitioner owns and is responsible for patient records shall:

1. Maintain a patient record for a minimum of six years following the last patient encounter with the following exceptions:

a. Records of a minor child shall be maintained until the child reaches the age of 18 years of age or becomes emancipated, with a minimum time for record retention of six years from the last patient encounter regardless of the age of the child;

b. Records that have previously been transferred to another practitioner or health care provider or provided to the patient or his the patient's personal representative; or

c. Records that are required by contractual obligation or federal law may need to be maintained for a longer period of time.

2. Post information or in some manner inform all patients concerning the timeframe for record retention and destruction. Patient records shall only be destroyed in a manner that protects patient confidentiality, such as by incineration or shredding.

3. When closing, selling, or relocating his practice, meet the requirements of § 54.1-2405 of the Code of Virginia for giving notice that copies of records can be sent to any like-regulated provider of the patient's choice or provided to the patient.

18VAC85-170-150. Practitioner-patient communication; termination of relationship.

A. Communication with patients.

1. Except as provided in § 32.1-127.1:03 F of the Code of Virginia, a practitioner shall accurately present information to a patient or his the patient's legally authorized representative in understandable terms and encourage participation in decisions regarding the patient's care.

2. A No practitioner shall not deliberately withhold pertinent findings or information or make a false or misleading statement regarding the practitioner's skill or the efficacy or value of a medication, treatment, or procedure provided or directed by the practitioner in the treatment of any disease or condition.

3. When a genetic procedure or diagnostic test is recommended, documented informed consent shall be obtained from the patient in accordance with the policies of the health care entity and consistent with the standard of care. Practitioners shall inform patients of the risks, benefits, and alternatives of the recommended procedure that a reasonably prudent practitioner practicing genetic counseling in Virginia would tell a patient.

a. In the instance of a minor or a patient who is incapable of making an informed decision on his own behalf or is incapable of communicating such a decision due to a physical or mental disorder, the legally authorized person available to give consent shall be informed and the consent documented.

b. An exception to the requirement for consent prior to performance of a genetic procedure may be made in an emergency situation when a delay in obtaining consent would likely result in imminent harm to the patient.

c. For the purposes of this provision, "genetic procedure" means any diagnostic or therapeutic procedure performed on a patient that is not part of routine, general care and for which the usual practice within the health care entity is to document specific informed consent from the patient or surrogate decisionmaker prior to proceeding.

4. Practitioners shall adhere to requirements of § 32.1-162.18 of the Code of Virginia for obtaining informed consent from patients prior to involving them those patients as subjects in human research, with the exception of retrospective chart reviews.

B. Termination of the practitioner-patient relationship.

1. The practitioner or the patient may terminate the relationship. In either case, the practitioner shall make the patient record available, except in situations where denial of access is allowed by law.

2. A No practitioner shall not terminate the relationship or make his the practitioner's services unavailable without documented notice to the patient that allows for a reasonable time to obtain the services of another practitioner.

18VAC85-170-160. Practitioner responsibility.

A. A No practitioner shall not:

1. Perform procedures or techniques that are outside the scope of his practice or for which he is not trained and individually competent;

2. 1. Knowingly allow subordinates to jeopardize patient safety or provide patient care outside of the subordinate's scope of practice or area of responsibility. Practitioners shall delegate patient care only to subordinates who are properly trained and supervised;

3. 2. Engage in an egregious pattern of disruptive behavior or interaction in a health care setting that interferes with patient care or could reasonably be expected to adversely impact the quality of care rendered to a patient; or

4. 3. Exploit the practitioner-patient relationship for personal gain.

B. Advocating for patient safety or improvement in patient care within a health care entity shall not constitute disruptive behavior, provided the practitioner does not engage in behavior prohibited in subdivision A 3 2 of this section.

18VAC85-170-170. Solicitation or remuneration in exchange for referral. (Repealed.)

A practitioner shall not knowingly and willfully solicit or receive any remuneration, directly or indirectly, in return for referring an individual to a facility as defined in § 37.2-100 of the Code of Virginia or hospital as defined in § 32.1-123 of the Code of Virginia.

"Remuneration" means compensation, received in cash or in kind, but shall not include any payments, business arrangements, or payment practices allowed by 42 USC § 1320a-7b(b), as amended, or any regulations promulgated thereto.