Title of Regulation: 18VAC60-21. Regulations Governing the Practice of Dentistry (amending 18VAC60-21-10, 18VAC60-21-60; adding 18VAC60-21-165).

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

Public Hearing Information:

February 18, 2022 - noon - Department of Health Professions, Perimeter Building, 9960 Mayland Drive, 2nd Floor, Board Room 4, Henrico, VA 23233

Public Comment Deadline: April 1, 2022.

Agency Contact: Sandra Reen, Executive Director, Board of Dentistry, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4437, FAX (804) 527-4428, or email sandra.reen@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 Dentistry the authority to promulgate regulations to administer the regulatory system. Section 54.1-2708.5 of the Code of Virginia provides for digital scans for use in the practice of dentistry and the practice of digital scan technicians.

Purpose: Provisions of Chapters 37 and 220 of the 2020 Acts of the Assembly set out the safeguards that must be in place for the practice of teledentistry, including the training and supervision of a digital scan technician if used in the practice. The purpose of the regulation is to specify the responsibility of the dentist for such training and supervision in order to protect the safety and health of patients receiving dental care via teledentistry.

Substance: The proposed regulation will establish requirements for a training program approved by the board to take digital scans of intraoral and extraoral hard and soft tissues for use in teledentistry; set out the responsibilities of the dentist for the practice of teledentistry and the training and supervision of a digital scan technician; and establish requirements for records that may be requested by the board.

Issues: The primary advantage to private citizens is that digital scan technicians will be required to have board-approved training prior to performing digital scans on a patient, thereby ensuring the safety of patients who receive digital dental scans outside of a dentist's office. There are no disadvantages to the public. There are no primary 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. In response to Chapters 37 and 220 of the 2020 Acts of Assembly,¹ the Board of Dentistry (Board) proposes to require dentists to ensure that digital scan technicians that engage in the practice of teledentistry are trained and supervised.

Background. According to the Department of Health Professions (DHP), the impetus for Chapters 37 and 220 was complaints expressed by Virginia residents who were improperly fitted for dental appliances provided by dental improvement companies. Dental scans taken of a patient's oral cavity serve as the blueprint for the fitting and fabricating of dental appliances. Improper or inaccurate dental scans often result in ill-fitting dental appliances, causing pain and discomfort. Although dental improvement companies fall under the Virginia definition of teledentistry, the Board does not regulate such businesses.

In response to these concerns, the Virginia General Assembly enacted Chapters 37 and 220. The legislation requires dental scan technicians to practice under the supervision of a dentist licensed in Virginia and to complete training approved by the Board. Although the legislation authorizes the Board to approve training programs for digital scan technicians and require dentists to ensure technicians have received appropriate training, it does not authorize the direct regulation of digital scan technicians. According to DHP, "the board does not have the statutory authority to license, certify, or register digital scan technicians. The [Virginia] Code requires the board to approve training and does not grant authority to regulate digital scan technicians."

Instead, the Board is authorized to regulate dentists and the Board proposes to require dentists to supervise and ensure that technicians complete training offered by any of the following: 1) Any sponsor listed in subsection C of 18VAC60-21-250;² 2) The American Association of Orthodontists and their constituent and component/branch associations, including the Virginia Association of Orthodontists; or 3) A training program certified by the manufacturer of the digital scanner.

Estimated Benefits and Costs. As evident from the consumer complaints the Board has received, the use of digital scans in the dental industry is not new, though DHP does not have data to assess its extent. For a variety of concerns such as consumer satisfaction, liability, and productivity, it would be reasonable to assume that it is also in the best interests of dentists and manufacturers of the scans that such technicians are equipped with proper training. Thus, it is likely most digital scan technicians are already provided some basic skills. The main purpose and effect of the legislation and the proposed regulatory language is to strengthen enforcement. Currently, the Board does not have authority to take action against dentists who may be employing untrained technicians in the practice of teledentistry.³ To the extent the proposed changes deter unscrupulous or untrained individuals from participating in teledentistry, health and safety risks to patients should be mitigated to some degree.

The proposed language does not specify the scope of training, only that the technician receive training provided by one of the entities listed above and is under the supervision of the dentist. Thus, there appears to be flexibility in designing the contents, length, and the method of training, which would ultimately determine its cost. It appears the most common form of training is by the manufacturers offered online free of charge to promote their equipment, and the Board is proposing to authorize this training and also the two additional sources noted above. There are no fees associated with this action, and no requirement for a scan technician to attend subsequent digital scan training sessions after initial training is complete. However, the Board currently does not have an estimate on what the training could cost.

Businesses and Other Entities Affected. The proposed amendments directly affect dentists who employ digital scan technicians in the practice of teledentistry, and indirectly affects the technicians themselves. The Board does not have information on the number of entities that are likely to be affected by the regulatory change. The 2020 legislation requires a Virginia license for any dentist who directs the taking of a digital scan via teledentistry, but there is no identifiable license for teledentistry. While the Board does not have specific data on dentists practicing by teledentistry, it notes that there was a substantial increase in the number of applicants for licensure from out-of-state in fiscal (FY) 2021; in FY 2020, there were 184 applicants from out-of-state and in FY 2021 there were 259 such applicants. No adverse economic impact⁴ on any entities is indicated.

Small Businesses⁵ Affected. Although the proposed regulation applies to any dentist employing digital scan technicians in the practice of teledentistry, the Board reports that most dentists who are affected would likely be employees of a national corporation. No adverse economic impact on small businesses is indicated.

Localities⁶ Affected.⁷ No effect on localities is expected.

Projected Impact on Employment. The proposed changes should deter untrained individuals from participating in teledentistry. Otherwise, no effect on total employment is expected.

Effects on the Use and Value of Private Property. The proposed changes do not appear to have an effect on the use and value of private property or the real estate development costs.

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¹https://lis.virginia.gov/cgi-bin/legp604.exe?201+ful+CHAP0037 & https://lis.virginia.gov/cgi-bin/legp604.exe?201+ful+CHAP0220

²https://law.lis.virginia.gov/admincode/title18/agency60/chapter21/section250/

³It should be noted that the scope of the proposed changes is limited to use of digital scans in the practice of teledentistry (i.e., taking of digital dental scans outside of a dentist's office). If the digital scans are taken at a dentist office, the Board already has authority to take action against the dentist.

⁴Adverse 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.

⁵Pursuant 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."

⁶"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.

⁷§ 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

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

Summary:

Pursuant to Chapters 37 and 220 of the 2020 Acts of Assembly, the proposed amendments (i) define a digital scan technician, as used in teledentistry, (ii) establish requirements for the training of technicians to practice under the direction of a dentist licensed in Virginia, and (iii) list the documentation a dentist providing direction to digital scan technician is responsible to make available to the board.

18VAC60-21-10. Definitions.

A. The following words and terms when used in this chapter shall have the meanings ascribed to them in § 54.1-2700 of the Code of Virginia:

"Appliance"

"Board"

"Dental hygiene"

"Dental hygienist"

"Dentist"

"Dentistry"

"Digital scan"

"Digital scan technician"

"Digital work order"

"License"

"Maxillofacial"

"Oral and maxillofacial surgeon"

"Teledentistry"

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

"AAOMS" means the American Association of Oral and Maxillofacial Surgeons.

"ADA" means the American Dental Association.

"Advertising" means a representation or other notice given to the public or members thereof, directly or indirectly, by a dentist on behalf of himself, his facility, his partner or associate, or any dentist affiliated with the dentist or his facility by any means or method for the purpose of inducing purchase, sale, or use of dental methods, services, treatments, operations, procedures, or products, or to promote continued or increased use of such dental methods, treatments, operations, procedures, or products.

"CODA" means the Commission on Dental Accreditation of the American Dental Association.

"Code" means the Code of Virginia.

"Dental assistant I" means any unlicensed person under the direction of a dentist or a dental hygienist who renders assistance for services provided to the patient as authorized under this chapter but shall not include an individual serving in purely an administrative, secretarial, or clerical capacity.

"Dental assistant II" means a person under the direction and direct supervision of a dentist who is registered by the board to perform reversible, intraoral procedures as specified in 18VAC60-21-150 and 18VAC60-21-160.

"Mobile dental facility" means a self-contained unit in which dentistry is practiced that is not confined to a single building and can be transported from one location to another.

"Nonsurgical laser" means a laser that is not capable of cutting or removing hard tissue, soft tissue, or tooth structure.

"Portable dental operation" means a nonfacility in which dental equipment used in the practice of dentistry is transported to and utilized on a temporary basis at an out-of-office location, including patients' homes, schools, nursing homes, or other institutions.

"Radiographs" means intraoral and extraoral radiographic images of hard and soft tissues used for purposes of diagnosis.

C. The following words and terms relating to supervision as used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Direct supervision" means that the dentist examines the patient and records diagnostic findings prior to delegating restorative or prosthetic treatment and related services to a dental assistant II for completion the same day or at a later date. The dentist prepares the tooth or teeth to be restored and remains immediately available in the office to the dental assistant II for guidance or assistance during the delivery of treatment and related services. The dentist examines the patient to evaluate the treatment and services before the patient is dismissed.

"Direction" means the level of supervision (i.e., immediate, direct, indirect, or general, or remote) that a dentist is required to exercise with a dental hygienist, a dental assistant I, a dental assistant II, or a certified registered nurse anesthetist or the level of supervision that a dental hygienist is required to exercise with a dental assistant to direct and oversee the delivery of treatment and related services. For the purpose of supervision of a digital scan technician, direction means the written or electronic instructions provided by a dentist licensed in Virginia to a digital scan technician in the form of a work order for a digital scan of a patient and the dentist's specified availability to consult with the technician while the scan is being taken.

"General supervision" means that a dentist completes a periodic comprehensive examination of the patient and issues a written order for hygiene treatment that states the specific services to be provided by a dental hygienist during one or more subsequent appointments when the dentist may or may not be present. Issuance of the order authorizes the dental hygienist to supervise a dental assistant performing duties delegable to dental assistants I.

"Immediate supervision" means the dentist is in the operatory to supervise the administration of sedation or provision of treatment.

"Indirect supervision" means the dentist examines the patient at some point during the appointment and is continuously present in the office to advise and assist a dental hygienist , a dental assistant, or a certified registered nurse anesthetist who is (i) delivering hygiene treatment, (ii) preparing the patient for examination or treatment by the dentist, (iii) preparing the patient for dismissal following treatment, or (iv) administering topical local anesthetic, sedation, or anesthesia as authorized by law or regulation.

"Remote supervision" means that a supervising dentist is accessible and available for communication and consultation with a dental hygienist during the delivery of dental hygiene services but such dentist may not have conducted an initial examination of the patients who are to be seen and treated by the dental hygienist and may not be present with the dental hygienist when dental hygiene services are being provided. For the purpose of practice by a public health dental hygienist, "remote supervision" means that a public health dentist has regular, periodic communications with a public health dental hygienist regarding patient treatment, but such dentist may not have conducted an initial examination of the patients who are to be seen and treated by the dental hygienist and may not be present with the dental hygienist when dental hygiene services are being provided. For the purpose of supervision of a digital scan technician, remote supervision means that a directing dentist is accessible and available for communication and consultation in the practice of teledentistry.

D. The following words and terms relating to sedation or anesthesia as used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Analgesia" means the diminution or elimination of pain.

"Continual" or "continually" means repeated regularly and frequently in a steady succession.

"Continuous" or "continuously" means prolonged without any interruption at any time.

"Deep sedation" means a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. Reflex withdrawal from a painful stimulus is not considered a purposeful response. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.

"General anesthesia" means a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilator function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.

"Inhalation" means a technique of administration in which a gaseous or volatile agent, including nitrous oxide, is introduced into the pulmonary tree and whose primary effect is due to absorption through the pulmonary bed.

"Inhalation analgesia" means the inhalation of nitrous oxide and oxygen to produce a state of reduced sensation of pain with minimal alteration of consciousness.

"Local anesthesia" means the elimination of sensation, especially pain, in one part of the body by the topical application or regional injection of a drug.

"Minimal sedation" means a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and physical coordination may be impaired, airway reflexes, and ventilator and cardiovascular functions are unaffected. Minimal sedation includes the diminution or elimination of anxiety through the use of pharmacological agents in a dosage that does not cause depression of consciousness and includes "inhalation analgesia" when used in combination with any such sedating agent administered prior to or during a procedure.

"Moderate sedation" means a drug-induced depression of consciousness, during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. Reflex withdrawal from a painful stimulus is not considered a purposeful response. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.

"Monitoring" means to observe, interpret, assess, and record appropriate physiologic functions of the body during sedative procedures and general anesthesia appropriate to the level of sedation as provided in Part VII (18VAC60-21-260 et seq.) of this chapter.

"Parenteral" means a technique of administration in which the drug bypasses the gastrointestinal tract (i.e., intramuscular, intravenous, intranasal, submucosal, subcutaneous, or intraocular).

"Provide" means, in the context of regulations for moderate sedation or deep sedation/general anesthesia, to supply, give, or issue sedating medications. A dentist who does not hold the applicable permit cannot be the provider of moderate sedation or deep sedation/general anesthesia.

"Titration" means the incremental increase in drug dosage to a level that provides the optimal therapeutic effect of sedation.

"Topical oral anesthetic" means any drug, available in creams, ointments, aerosols, sprays, lotions, or jellies, that can be used orally for the purpose of rendering the oral cavity insensitive to pain without affecting consciousness.

18VAC60-21-60. General responsibilities to patients.

A. A dentist is responsible for conducting his practice in a manner that safeguards the safety, health, and welfare of his patients and the public by:

1. Maintaining a safe and sanitary practice, including containing or isolating pets away from the treatment areas of the dental practice. An exception shall be made for a service dog trained to accompany its owner or handler for the purpose of carrying items, retrieving objects, pulling a wheelchair, alerting the owner or handler to medical conditions, or other such activities of service or support necessary to mitigate a disability.

2. Consulting with or referring patients to other practitioners with specialized knowledge, skills, and experience when needed to safeguard and advance the health of the patient.

3. Treating according to the patient's desires only to the extent that such treatment is within the bounds of accepted treatment and only after the patient has been given a treatment recommendation and an explanation of the acceptable alternatives.

4. Only delegating patient care and exposure of dental x-rays or taking of digital scans to qualified, properly trained, and supervised personnel as authorized in Part IV (18VAC60-21-110 et seq.) of this chapter.

5. Giving patients at least 30 days written notice of a decision to terminate the dentist-patient relationship.

6. Knowing the signs of abuse and neglect and reporting suspected cases to the proper authorities consistent with state law.

7. Accurately representing to a patient and the public the materials or methods and techniques to be used in treatment.

B. A dentist is responsible for conducting his financial responsibilities to patients and third party payers in an ethical and honest manner by:

1. Maintaining a listing of customary fees and representing all fees being charged clearly and accurately.

2. Making a full and fair disclosure to his the dentist's patient of all terms and considerations before entering into a payment agreement for services.

3. Not obtaining, attempting to obtain, or cooperating with others in obtaining payment for services by misrepresenting procedures performed, dates of service, or status of treatment.

4. Making a full and fair disclosure to his the dentist's patient of any financial incentives he the dentist received for promoting or selling products.

5. Not exploiting the dentist-patient relationship for personal gain related in nondental transactions.

18VAC60-21-165. Delegation to digital scan technicians for use in teledentistry.

A. Any digital scan technician taking intraoral digital scans for any appliance, prothesis, crown, or any other permanent or removable dental device for which a digital work order is required must complete a training program approved by the board. Training certification may be earned by verifiable participation in any course that is relevant to digital scanning that includes programs by any of the following sponsors:

1. Any sponsor listed in subsection C of 18VAC60-21-250; or

2. A training program certified by the manufacturer of the digital scanner.

B. The dentist under whom a digital scan technician is directed to take digital scans shall establish written or electronic protocols for:

1. The practice of teledentistry in compliance with subsection C of § 54.1-2711 of the Code of Virginia and any other provisions required by the board; and

2. The performance of digital scans by digital scan technicians in compliance with subsection B of § 54.1-2708.5 of the Code of Virginia.

C. The dentist under whom a digital scan technician is directed to take digital scans shall be:

1. Licensed by the board to practice dentistry in the Commonwealth;

2. Accessible and available for communication and consultation with the digital scan technician at all times during the patient interaction;

3. Responsible for ensuring that the digital scan technician has a program of training approved by the board for such purpose; and

4. Ultimately responsible for determining with the patient or the patient's representative the specific treatment the patient will receive, which aspects of treatment will be delegated to qualified personnel, and the direction required for such treatment, in accordance with this chapter and the Code of Virginia.

D. The directing dentist shall make available to the board any requested:

1. Protocols and procedures;

2. Evidence that a digital scan technician has complied with the training requirements of the board; and

3. All written or electronic work orders used for digital scans.