Moderate Sedation

PURPOSE: This rule provides for the regulation of the administration of moderate sedation in a dental office. (1) Because sedation and general anesthesia are a continuum, it is not always possible to predict how an individual patient will respond. Hence, practitioners intending to produce a given level of sedation should be able to diagnose and manage the physiologic consequences (rescue) for patients whose level of sedation becomes deeper than initially intended. For all levels of sedation, the practitioner must have the training, skills, drugs, and equipment to identify and manage such an occurrence until either assistance arrives (emergency medical service) or the patient returns to the intended level of sedation without airway or cardiovascular complication. (2) No dentist shall administer enteral and/or parenteral moderate sedation unless the dentist possesses a moderate sedation permit issued by the Missouri Dental Board. (A dentist is not required to possess a permit for the prescription or administration of drugs prescribed for minimal sedation and/or pain control.) This permit shall be renewed by June 1 every five (5) years from the year of issuance. (3) No dentist shall prescribe sedative agents for enteral moderate sedation unless the dentist possesses an enteral or parenteral moderate sedation permit issued by the Missouri Dental Board. No dentist shall prescribe parenteral moderate sedation agents unless the dentist possesses a parenteral moderate sedation permit issued by the Missouri Dental Board. (4) No dentist shall administer moderate sedation to a pediatric patient, as defined in 20 CSR 2110-4.010, unless the dentist possesses a pediatric moderate sedation permit. A dentist possessing a pediatric moderate sedation permit may administer moderate sedation using either enteral or parenteral techniques; however, techniques utilizing intravenous administration are restricted to qualified deep sedation/general anesthesia providers as defined in 20 CSR 2110-4.040. Moderate sedation services provided to pediatric patients shall be done in accordance with current American Academy of Pediatric Dentistry Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures. (5) No dental office shall be the site for the administration of enteral, parenteral, or pediatric moderate sedation without being issued a moderate sedation site certificate by the Missouri Dental Board. This site certificate shall be renewed by June 1 every five (5) years from the year of issuance. The dentistin-charge is responsible for submitting the application and maintaining the documentation as required in sections (12) and (14) of this rule. (6) If the primary administrator of enteral, parenteral, or pediatric moderate sedation in a dental office is a certified registered nurse anesthetist, the operating dentist must possess the appropriate moderate sedation permit for the service being provided. (7) If the primary administrator of enteral, parenteral, or pediatric moderate sedation in a dental office is an anesthesiologist or a certified registered nurse anesthetist, the operating dentist must order the anesthesia services and is responsible for the readiness of the dental office, preoperative patient evaluation and appropriate medical consultations, the coordination of and emergency preparedness of the sedation team, and the maintenance of appropriate records. The dentist must evaluate the patient prior to the procedure, remain in the dental office, and evaluate the patient prior to discharge. (8) To qualify for a permit to administer enteral moderate sedation, a dentist shall— (A) Document satisfactory completion of— 1. An enteral moderate sedation training course consistent with the American Dental Association Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students; or 2. An ADA-accredited post-doctoral training program that affords training necessary to administer enteral moderate sedation; or 3. An enteral moderate sedation course approved by the Missouri Dental Board; (B) Document— 1. Current certification in Advanced Cardiac Life Support (ACLS); and 2. Completion during the past five (5) years of a minimum of fifteen (15) hours of other board-approved continuing education pertaining to airway management in sedated patients. 3. Additional hours, not to exceed five (5), acquired beyond the required number may be carried forward into the renewal cycle; and (C) Successfully complete an evaluation by consultants appointed by the board. (9) To qualify for a permit to administer parenteral moderate sedation, a dentist shall— (A) Document satisfactory completion of a parenteral moderate sedation training program that includes: 1. Sixty (60) hours of didactic training in pain and anxiety control and related subjects in accordance with current guidelines of the ADA for teaching pain control and sedation to dentists and dental students; 2. Successful management of parenteral moderate sedation in twenty (20) dental patients. Management of parenteral moderate sedation is defined as performing and being responsible for all aspects of the sedation procedure from patient selection to patient discharge post sedation for each of the twenty (20) dental patients; 3. General anesthesia training in a hospital accredited by The Joint Commission in which there is four (4) weeks documented operating room clinical experience in airway management; 4. Certification of competency by the course director in airway management; and 5. Certification of competency by the course director in parenteral moderate sedation; (B) Document current certification in Advanced Cardiac Life Support (ACLS); and (C) Successfully complete an on-site evaluation by consultants appointed by the board. On-site evaluations shall be conducted in accordance with 20 CSR 2110-4.030. (10) To qualify for a permit to administer pediatric moderate sedation, a dentist shall— (A) Document satisfactory completion of an ADA-accredited post-doctoral training program that is a minimum of twelve (12) continuous months in length and which affords comprehensive and appropriate training necessary to administer and manage moderate sedation in pediatric patients. This program shall include: 1. A minimum of sixty (60) hours of didactic training in pain and anxiety control in pediatric patients; 2. Successful management of moderate sedation in twenty (20) pediatric dental patients. Management is defined as responsible for all aspects of the sedation procedure from patient selection to patient discharge post sedation; 3. General anesthesia training in which there is four (4) weeks documented clinical experience in airway management; 4. Certification of competency by the course director in airway management; and 5. Certification of competency by the course director in pediatric moderate sedation; (B) Document current certification in Advanced Cardiac Life Support (ACLS) course or Pediatric Advanced Life Support (PALS); and (C) Successfully complete an on-site evaluation by consultants appointed by the board. On-site evaluations shall be conducted in accordance with 20 CSR 2110-4.030. (11) To qualify for a moderate sedation site certificate— (A) The dentist-in-charge of the dental office shall document that— 1. The primary administrator of enteral, parenteral, or pediatric moderate sedation is a qualified sedation provider as set forth in 20 CSR 2110-4.010(1)(CC); 2. All moderate sedation team members (two (2) minimum) and the dentist possess and maintain current certification in the American Heart Association’s Basic Life Support for the Healthcare Provider (BLS) or an equivalent certification approved by the Missouri Dental Board. Board-approved courses are those that meet the American Heart Association guidelines for cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC) and provide written and manikin testing on the course material by an instructor who is physically present with the students. Online only courses will not be accepted to satisfy the BLS requirement or ACLS; 3. All moderate sedation team members, including the dentist, if s/he does not possess an active moderate sedation permit, have completed a board-approved course in monitoring sedated patients during the past five (5) years; 4. The dental office is properly maintained and equipped as set forth in 20 CSR 2110-4.030; and 5. The dental office has written protocols for sedation of dental patients as set forth in 20 CSR 2110-4.030, including but not limited to, the following: A. Preoperative patient evaluation and selection prior to enteral, parenteral, or pediatric moderate sedation; B. Informed consent procedures; C. Sedation monitoring procedures; D. Maintaining appropriate records during sedation procedures; E. Patient discharge assessment; and F. Responding to emergencies incident to the administration of enteral, parenteral, or pediatric moderate sedation; and (B) The dental office shall undergo a facility inspection as set forth in 20 CSR 21104.030 to confirm the adequacy of the dental office and the qualifications of the sedation team. (12) The board shall issue an enteral, parenteral, or pediatric moderate sedation permit upon receipt of a completed application form, payment of the appropriate fee specified in 20 CSR 2110-2.170, proof of having met the requirements of sections (7), (8), or (9) of this rule, and determination that the applicant is a licensee in good standing. To be in good standing the licensee’s dental license(s) must be current and not under restriction or discipline in any state. The requirements of this section must be completed within one (1) year of the date of submission of the application form. (13) The board shall issue a moderate sedation site certificate upon receipt of a completed application form, payment of the appropriate fee specified in 20 CSR 2110-2.170, and proof of having met the requirements of section (10) of this rule. The requirements of this section must be completed within one (1) year of the date of submission of the application form. (14) To renew a permit to administer enteral, parenteral, or pediatric moderate sedation a dentist shall, at least ninety (90) days prior to the expiration of the current permit— (A) Submit a completed renewal application form provided by the board; (B) Submit to the board a minimum of five (5) unedited, complete patient records of the permitted dentist administering enteral, parenteral, or pediatric moderate sedation in the dental office from the preceding five (5) years, documenting management of moderate sedation patients in accordance with the criteria set forth in 20 CSR 2110-4.030; (C) Submit the renewal fee specified in 20 CSR 2110-2.170 payable to the Missouri Dental Board; and (D) Document— 1. Current certification in Advanced Cardiac Life Support (ACLS); and 2. Completion during the past five (5) years of a minimum of fifteen (15) hours of other board-approved continuing education pertaining to airway management in sedated patients. 3. Additional hours, not to exceed five (5), acquired beyond the required number may be carried forward into the renewal cycle. (15) To renew a moderate sedation site certificate the dentist-in-charge shall, at least ninety (90) days prior to the expiration of the current site certificate— (A) Submit a completed renewal application form provided by the board; (B) Submit the renewal fee specified in 20 CSR 2110-2.170 payable to the Missouri Dental Board; (C) Attest that the primary administrator of enteral, parenteral, or pediatric moderate sedation is a qualified sedation provider as set forth in 20 CSR 2110-4.010(1)(CC); (D) Document that the sedation team, as well as the permitted dentist, possess and maintain current certification in the American Heart Association’s Basic Life Support for the Healthcare Provider (BLS) or an equivalent certification approved by the Missouri Dental Board. Board-approved courses are those that meet the American Heart Association guidelines for cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC) and provide written and manikin testing on the course material by an instructor who is physically present with the students. Online only courses will not be accepted to satisfy the BLS requirement, or the American Red Cross recognized equivalent certification, or ACLS; (E) Document that all moderate sedation team members, including the operating dentist, if s/he does not possess an active moderate sedation permit, have completed a boardapproved course in monitoring sedated patients during the past five (5) years; and (F) Undergo a facility inspection as set forth in 20 CSR 2110-4.030 to confirm the adequacy of the dental office and the qualifications of the sedation team. (16) Each dentist possessing a permit to administer enteral, parenteral, or pediatric moderate sedation shall maintain current certification in Advanced Cardiac Life Support (ACLS) at all times the sedation permit is active. (17) A dentist holding a current enteral conscious sedation permit on or before the effective date of this rule is authorized to perform all means of enteral moderate sedation set forth in 20 CSR 2110-4.010(1)(L) and, upon renewal, will receive a permit to administer enteral moderate sedation upon compliance with the renewal requirements set forth in section (13) of this rule. (18) A dentist holding a current parenteral conscious sedation permit on or before the effective date of this rule is authorized to perform all means of parenteral moderate sedation set forth in 20 CSR 2110-4.010(1)(Y) and, upon renewal, will receive a permit to administer parenteral moderate sedation upon compliance with the renewal requirements set forth in section (13) of this rule. (19) A dental office holding a current conscious sedation site certificate on or before the effective date of this rule is authorized to be the site for the administration of enteral, parenteral, or pediatric moderate sedation and, upon renewal, will receive a moderate sedation site certificate. (20) A dentist holding a permit of authorization for the administration of parenteral moderate sedation may use enteral moderate sedation without a permit for enteral moderate sedation. A dentist holding a permit of authorization for the administration of deep sedation/general anesthesia under 20 CSR 21104.040 may use enteral, parenteral, and/or pediatric moderate sedation without a permit for enteral, parenteral, and/or pediatric moderate sedation. (21) The dentist-in-charge of a dental office in receipt of a moderate sedation site certificate must ensure that the moderate sedation team meets the clinical requirements and the dental office meets the standards for utilization as set forth in 20 CSR 2110-4.030. (22) At any time, the board may inspect a dental office where enteral, parenteral, or pediatric moderate sedation is administered in order to verify compliance with the minimum requirements of this rule. (23) If at any time the board learns that a dentist who holds a permit to administer enteral, parenteral, or pediatric moderate sedation, or a moderate sedation site certificate has failed to meet the minimum qualifications set out in this rule, the board may pursue disciplinary action in accordance with section 332.321, RSMo. (24) Due to narrow therapeutic dose ranges for moderate sedation, use of thiopental, methohexital, and propofol for moderate sedation of dental patients will be restricted to qualified deep sedation/general anesthesia providers as defined in 20 CSR 2110-4.040. (25) The provisions of this rule are declared severable. If any provision of this rule is held invalid by a court of competent jurisdiction, the remaining provisions of this rule shall remain in full force and effect unless otherwise determined by a court of competent jurisdiction. AUTHORITY: sections 332.031 and 332.071, RSMo 2016, and section 332.361, RSMo Supp. 2021.* This rule originally filed as 4 CSR 110-4.020. Original rule filed Sept. 15, 2004, effective April 30, 2005. Moved to 20 CSR 2110-4.020, effective Aug. 28, 2006. Rescinded and readopted: Filed July 26, 2012, effective Feb. 28, 2013. Amended: Filed Oct. 4, 2018, effective April 30, 2019. ** Amended: Filed Feb. 23, 2022, effective Sept. 30, 2022. *Original authority: 332.031, RSMo 1969, amended 1981, 1993, 1995; 332.071, RSMo 1969, amended 1976, 1995, 2003, 2004, 2006; and 332.361, RSMo 1969, amended 1981, 2019. **Pursuant to Executive Order 21-09, 20 CSR 2110-4.020, paragraph (11)(A)2. and subsection (15)(D) was suspended from April 10, 2020 through September 15, 2021.