Title of Regulation: 18VAC60-20. Regulations Governing the Practice of Dentistry and Dental Hygiene (amending 18VAC60-20-10, 18VAC60-20-30; adding 18VAC60-20-332, 18VAC60-20-342, 18VAC60-20-352).

Statutory Authority: §§ 54.1-2400 and 54.1-2708.3 of the Code of Virginia.

Public Hearing Information:

February 25, 2011 – 9 a.m. - Board of Dentistry, Perimeter Center, 9960 Mayland Drive, 2nd Floor, Board Room 3, Richmond, VA

Public Comment Deadline: March 4, 2011.

Agency Contact: Sandra Reen, Executive Director, Board of Dentistry, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4538, FAX (804) 527-4428, or email sandra.reen@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia provides the Board of Dentistry the authority to promulgate regulations to administer the regulatory system. The specific mandate to promulgate regulations for the registration of mobile dental clinics is found in § 54.1-2708.3 of the Code of Virginia.

Purpose: To protect the health and safety of persons served in mobile dental clinics, amendments to 18VAC60-20 require registration to include information about where and when the practices will be operating and which practitioners will be providing care. The clinics must also certify to agreements for follow-up care, emergency contact arrangements, access to all essential equipment, and conformity to laws and regulations. There must be written consent to dental care in a mobile clinic, and patients must be provided with an information sheet that details who provided treatment, a description of the treatment and any additional dental needs, a recommendation or referral for follow-up care, and emergency contact information. Such requirements are necessary to ensure that patients (often school children) are not left with unresolved dental problems or with little or no information about what was done during a visit by a mobile clinic. Finally, regulations stipulate that the same rules and standards of care apply for practice in a mobile clinic as in a fixed facility.

Substance: The key provisions of the regulations are: (i) establishment of definitions of a mobile dental clinic and a portable dental operation; (ii) requirements for registration including information on locations, dates, and practitioners providing services; certifications of agreements for follow-up care and access to emergency care; certification of availability of certain equipment and resources; and conformity to operational and permitting standards; (iii) requirements for operation of the clinic, including posting of licenses, written consent for treatment, information on treatment and needed follow-up for patients, and maintenance of patient records; and (iv) exemptions from the requirements for registration for governmental agencies and periodic volunteer clinics providing free care.

Issues: The primary advantage to the public is more accountability for mobile dental clinics providing services to school children and others in Virginia. Information on practitioners and locations, appropriate procedures for follow-up care and emergencies, and adequate equipment for such clinics will provide some assurance that the care being given is safe and competent. The disadvantage could be that the registration process may discourage some clinic operations from coming into Virginia, thus reducing access to care. In passing the mandate for registration, members of the General Assembly determined that the advantages for greater protection in dental care outweighed the potential for any loss of access.

There are no advantages or disadvantages to the Commonwealth; the board set the application and renewal fee with the goal of covering expenditures related to registration of mobile dental clinics.

The Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Item 303 of the 2009 Appropriation Act and Chapter 405 of the 2010 Acts of Assembly, the Board of Dentistry proposes to require that mobile dental clinics: 1) register with the Department of Health Professions (Department), 2) pay an initial $250 application fee and an annual $150 renewal fee, 3) provide the Department with the locations of where services are provided, and identity and license numbers of staff, 4) have a written agreement for emergency follow-up care for patients to include identification of and arrangements for treatment in a dental office which is permanently established within a reasonable geographic area, 5) certify that that the facility or operation has access to communication facilities that enable the dental personnel to contact assistance in the event of a medical or dental emergency, 6) certify that the facility has a water supply and all equipment necessary to provide the dental services to be rendered therein, 7) certify that the facility or operation conforms to all applicable federal, state and local laws, regulations and ordinances, 8) certify that the applicant possesses all applicable city or county licenses or permits to operate the facility, 9) obtain written consent from the patient, parent, guardian or authorized representative prior to treatment, 10) provide each patient with an information sheet that includes information such as description of the treatment rendered, names of staff providing treatment, billed service codes and fees, description of any additional dental needs diagnosed, referral recommendation to another dentist if the facility or operation is unable to provide follow-up treatment, and emergency contact information, and 11) maintain secure records. The proposed regulations also specify that federal, state, and local governmental agencies and dental treatment which is provided without charge to patients or to any third party payer are exempt.

Result of Analysis. There is insufficient data to accurately compare the magnitude of the benefits versus the costs. Detailed analysis of the benefits and costs can be found in the next section.

Estimated Economic Impact. In terms of fees (initial $250 application fee and an annual $150 renewal fee) and paperwork (listed in above summary) there are non-negligible new costs associated with the proposed new requirements for mobile dental clinics, but the costs are not likely large enough to discourage most potential for-profit clinics. Given that treatment which is provided without charge to patients is exempt and that the costs are not likely large enough to discourage most potential for-profit clinics, the proposed regulations are unlikely to result in diminished dental services.

The required registration, fees, recordkeeping, and associated procedures for mobile dental clinics do likely provide benefits for the public in that there is greater accountability for the dental services being provided and increased assurance that follow-up care has been arranged. The degree to which mobile clinics would provide necessary information for follow-up care and quality service without these proposed requirements is not known. Thus an accurate estimate of the magnitude of the benefits cannot be definitively established.

Businesses and Entities Affected. The proposed amendments affect the two current mobile dental clinics in Virginia plus any potential future mobile dental clinics. According to the Department, the larger current mobile dental clinic primarily serves children at schools throughout the Commonwealth, while the other current mobile dental clinic primarily serves older adults in central Virginia.

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

Projected Impact on Employment. The proposal amendments do raise costs for mobile dental clinics, but likely not enough to significantly affect total employment.

Effects on the Use and Value of Private Property. The proposed amendments increase costs for mobile dental clinics through an application fee of $250 and an annual renewal fee of $150, as well as required paperwork and recordkeeping.

Small Businesses: Costs and Other Effects. Essentially all dental clinics qualify as small businesses. The proposed amendments increase costs for mobile dental clinics through an application fee of $250 and an annual renewal fee of $150, as well as required paperwork and recordkeeping.

Small Businesses: Alternative Method that Minimizes Adverse Impact. There are no clear alternatives that both satisfy the legislative mandate and reduce costs.

Real Estate Development Costs. The proposed amendments are unlikely to significantly affect real estate development costs.

Legal Mandate. 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 Administrative Process Act and Executive Order Number 107 (09). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the 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. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPBs best estimate of these economic impacts.

Agency's Response to the Department of Planning and Budget's Economic Impact Analysis: In general, the Board of Dentistry concurs with the analysis of the Department of Planning and Budget for the proposed regulation, 18VAC60-20, Regulations Governing the Practice of Dentistry and Dental Hygiene, relating to registration of mobile dental clinics with two exceptions:

1. The requirement for a written agreement for follow-up care is to include identification of and arrangements for treatment in a dental office that is permanently established within a reasonable geographic area, rather than a written agreement for emergency follow-up care as described in #4 of the first paragraph. There is also a requirement for access to communication facilities that enable the dental personnel to contact assistance in the event of a medical or dental emergency; and

2. It should be noted that the two mobile clinics registered and operating in Virginia have already paid an application fee pursuant to emergency regulations, so the proposed regulations do not impose a new requirement or cost for registration.

Summary:

Pursuant to Item 303 of the 2009 Appropriation Act (Chapter 781 of the 2009 Acts of Assembly) and Chapter 405 of the 2010 Acts of Assembly, the proposed regulations establish requirements for registration of mobile dental clinics and other portable dental operations. The proposed regulations require that mobile dental clinics and other portable dental operations (i) register with the Department of Health Professions; (ii) pay an initial $250 application fee and an annual $150 renewal fee; (iii) provide the department with the (a) locations of where services are provided and (b) identity and license numbers of staff; (iv) have a written agreement for emergency follow-up care for patients to include identification of and arrangements for treatment in a dental office that is permanently established within a reasonable geographic area; (v) certify that that the facility or operation has access to communication facilities that enable the dental personnel to contact assistance in the event of a medical or dental emergency; (vi) certify that the facility has a water supply and all equipment necessary to provide the dental services to be rendered at the facility; (vii) certify that the facility or operation conforms to all applicable federal, state, and local laws, regulations, and ordinances; (viii) certify that the applicant possesses all applicable city or county licenses or permits to operate the facility; (ix) obtain written consent from the patient, parent, guardian, or authorized representative prior to treatment; (x) provide each patient with an information sheet that includes information such as description of the treatment rendered, names of staff providing treatment, billed service codes and fees, description of any additional dental needs diagnosed, referral recommendation to another dentist if the facility or operation is unable to provide follow-up treatment, and emergency contact information; and (xi) maintain secure records. Governmental agencies and periodic volunteer clinics providing free care are exempted from the registration requirements.

Emergency regulations implementing registration requirements are currently in effect.

Part I
General Provisions

18VAC60-20-10. Definitions.

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

"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.

"Analgesia" means the diminution or elimination of pain in the conscious patient.

"Anxiolysis" means the diminution or elimination of anxiety through the use of pharmacological agents in a dosage that does not cause depression of consciousness.

"Conscious sedation" means a minimally depressed level of consciousness that retains the patient's ability to independently and continuously maintain an airway and respond appropriately to physical stimulation and verbal commands, produced by pharmacological or nonpharmacological methods, including inhalation, parenteral, transdermal or enteral, or a combination thereof.

"Deep sedation/general anesthesia" means an induced state of depressed consciousness or unconsciousness accompanied by a complete or partial loss of protective reflexes, including the inability to continually maintain an airway independently and/or respond purposefully to physical stimulation or verbal command and is produced by a pharmacological or nonpharmacological method or a combination thereof.

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

"Direction" means the dentist examines the patient and is present for observation, advice, and control over the performance of dental services.

"Enteral" is any technique of administration in which the agent is absorbed through the gastrointestinal tract or oral mucosa (i.e., oral, rectal, sublingual).

"General supervision" means that the dentist has examined the patient and issued a written order for the specific, authorized services to be provided by a dental hygienist when the dentist is not present in the facility while the services are being provided.

"Inhalation" is 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 sensibility to pain without the loss of consciousness.

"Local anesthesia" means the loss of sensation or pain in the oral cavity or the maxillofacial or adjacent and associated structures generally produced by a topically applied or injected agent without depressing the level of consciousness.

"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.

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

"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 x-rays of hard and soft tissues to be used for purposes of diagnosis.

18VAC60-20-30. Other fees.

A. Dental licensure application fees. The application fee for a dental license by examination, a license to teach dentistry, a full-time faculty license, or a temporary permit as a dentist shall be $400. The application fee for dental license by credentials shall be $500.

B. Dental hygiene licensure application fees. The application fee for a dental hygiene license by examination, a license to teach dental hygiene, or a temporary permit as a dental hygienist shall be $175. The application fee for dental hygienist license by endorsement shall be $275.

C. Duplicate wall certificate. Licensees desiring a duplicate wall certificate shall submit a request in writing stating the necessity for such duplicate wall certificate, accompanied by a fee of $60.

D. Duplicate license. Licensees desiring a duplicate license shall submit a request in writing stating the necessity for such duplicate license, accompanied by a fee of $20. If a licensee maintains more than one office, a notarized photocopy of a license may be used.

E. Licensure certification. Licensees requesting endorsement or certification by this board shall pay a fee of $35 for each endorsement or certification.

F. Restricted license. Restricted license issued in accordance with § 54.1-2714 of the Code of Virginia shall be at a fee of $285.

G. Restricted volunteer license. The application fee for licensure as a restricted volunteer dentist or dental hygienist issued in accordance with § 54.1-2712.1 or § 54.1-2726.1 of the Code of Virginia shall be $25.

H. Returned check. The fee for a returned check shall be $35.

I. Inspection fee. The fee for an inspection of a dental office shall be $350.

J. Mobile dental clinic or portable dental operation. The application fee for registration of a mobile dental clinic or portable dental operation shall be $250. The annual renewal fee shall be $150 and shall be due by December 31. A late fee of $50 shall be charged for renewal received after that date.

Part VIII
Mobile Dental Clinics and Portable Dental Operations

18VAC60-20-332. Registration of a mobile dental clinic or portable dental operation.

A. An applicant for registration of a mobile dental facility or portable dental operation shall provide:

1. The name and address of the owner of the facility or operation and an official address of record for the facility or operation, which shall not be a post office address. Notice shall be given to the board within 30 days if there is a change in the ownership or the address of record for a mobile dental facility or portable dental operation;

2. The name, address, and license number of each dentist and dental hygienist or the name, address, and registration number of each dental assistant II who will provide dental services in the facility or operation. The identity and license or registration number of any additional dentists, dental hygienists, or dental assistants II providing dental services in a mobile dental facility or portable dental operation shall be provided to the board in writing prior to the provision of such services; and

3. The address or location of each place where the mobile dental facility or portable dental operation will provide dental services and the dates on which such services will be provided. Any additional locations or dates for the provision of dental services in a mobile dental facility or portable dental operation shall be provided to the board in writing prior to the provision of such services.

B. The information provided by an applicant to comply with subsection A of this section shall be made available to the public.

C. An application for registration of a mobile dental facility or portable dental operation shall include:

1. Certification that there is a written agreement for follow-up care for patients to include identification of and arrangements for treatment in a dental office that is permanently established within a reasonable geographic area;

2. Certification that the facility or operation has access to communication facilities that enable the dental personnel to contact assistance in the event of a medical or dental emergency;

3. Certification that the facility has a water supply and all equipment necessary to provide the dental services to be rendered therein;

4. Certification that the facility or operation conforms to all applicable federal, state, and local laws, regulations, and ordinances dealing with radiographic equipment, sanitation, zoning, flammability, and construction standards; and

5. Certification that the applicant possesses all applicable city or county licenses or permits to operate the facility or operation.

D. Registration may be denied or revoked for a violation of provisions of § 54.1-2706 of the Code of Virginia.

18VAC60-20-342. Requirements for a mobile dental clinic or portable dental operation.

A. The registration of the facility or operation and copies of the licenses of the dentists and dental hygienists or registrations of the dental assistants II shall be displayed in plain view of patients.

B. Prior to treatment, the facility or operation shall obtain written consent from the patient or, if the patient is a minor or incapable of consent, his parent, guardian, or authorized representative.

C. Each patient shall be provided with an information sheet, or if the patient, his parent, guardian, or authorized agent has given written consent to an institution or school to have access to the patient's dental health record, the institution or school may be provided a copy of the information. At a minimum, the information sheet shall include:

1. Patient name, date of service, and location where treatment was provided;

2. Name of dentist or dental hygienist who provided services;

3. Description of the treatment rendered and tooth numbers, when appropriate;

4. Billed service codes and fees associated with treatment;

5. Description of any additional dental needs observed or diagnosed;

6. Referral or recommendation to another dentist if the facility or operation is unable to provide follow-up treatment; and

7. Emergency contact information.

D. Patient records shall be maintained, as required by 18VAC60-20-15, in a secure manner within the facility or at the address of record listed on the registration application. Records shall be made available upon request by the patient, his parent, guardian, or authorized representative and shall be available to the board for inspection and copying.

E. The practice of dentistry and dental hygiene in a mobile dental clinic or portable dental operation shall be in accordance with the laws and regulations governing such practice.

18VAC60-20-352. Exemptions from requirement for registration.

The following shall be exempt from requirements for registration as a mobile dental clinic or portable dental operation:

1. All federal, state, or local governmental agencies; and

2. Dental treatment that is provided without charge to patients or to any third party payer.

FORMS (18VAC60-20)

Application Requirements for Dentists (rev. 8/08).

Application for License to Practice Dentistry (rev. 8/08).

Application Requirements for Restricted Dental Volunteer License/Restricted Dental Hygiene License (rev. 8/08).

Application for Restricted Volunteer License to Practice Dentistry or Dental Hygiene (rev. 8/08).

Requirements and Instructions for a Temporary Resident's License to Persons Enrolled in Advanced Dental Education Programs (rev. 5/08).

Application for Temporary Resident's License (rev. 5/08).

Form A, Certification of Dental School for Temporary Resident's License (rev. 5/08).

Form B, Temporary Resident's License (Certification from Dean of Dental School or Director of Accredited Graduate Program) (rev. 5/08).

Form C, Temporary Resident's License (Certification of Dental Licensure) (rev. 5/08).

Form D, Temporary Resident's License (Chronology) (rev. 5/08).

Form A, Certification of Dental/Dental Hygiene School (rev. 8/08).

Form AA, Sponsor Certification for Dental/Dental Hygiene Volunteer License (rev. 8/08).

Form B, Chronology (rev. 8/08).

Form C, Certification of Dental/Dental Hygiene Boards (rev. 8/08).

Application Requirements for Dental Hygienists (rev. 1/08).

Application for Licensure to Practice Dental Hygiene (rev. 1/08).

Instructions for Reinstatement of License (rev. 4/08).

Reinstatement Application for Dental/Dental Hygiene Licensure (rev. 4/08).

Instructions for Application for Reactivation of License (rev. 8/08).

Application for Reactivation of License (rev. 8/08).

Application for Certification to Perform Cosmetic Procedures (rev. 8/08).

Oral and Maxillofacial Surgeon Registration of Practice (rev. 8/08).

Application for Registration for Volunteer Practice (rev. 8/08).

Sponsor Certification for Volunteer Registration (rev. 8/08).

Application for Registration of a Mobile Dental Facility or Portable Dental Operation (eff. 6/10).