PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action:
Amendment of section 61.9 of Title 8 NYCRR.
Statutory authority:
Education Law, sections 207(not subdivided), 6504(not subdivided), 6507(2)(a), 6606(1), (2), 6608 and 6611(10); L. 2013, ch. 239
Subject:
Dental Hygiene Collaborative Arrangements.
Purpose:
To implement chapter 239 of the Laws of 2013.
Text of proposed rule:
1. The introductory paragraph of section 61.9 of the Regulations of the Commissioner of Education is amended, effective January 1, 2015, to read as follows:
The practice of dental hygiene, in accordance with section 6606 of the Education Law, shall be performed either under the supervision of a licensed dentist or pursuant to a collaborative arrangement as defined in subdivision (f) of this section.
2. Subdivision (b) of section 61.9 of the Regulations of the Commissioner of Education is amended, effective January 1, 2015, to read as follows:
(b) The following services may be performed under the general supervision of a licensed dentist:
(1) . . .
(2) . . .
(3) . . .
(4) providing patient education and counseling relating to the improvement of oral health;
(5) [placing and exposing X-ray films] taking and exposing dental radiographs;
(6) . . .
(7) . . .
(8) taking and assessing medical history including the measuring and recording of vital signs as an aid to diagnosis by the dentist and to assist the dental hygienist in providing dental hygiene services;
(9) [charting caries and] performing dental and/or periodontal [conditions] assessments as an aid to diagnosis by the dentist and to assist the dental hygienist in providing dental hygiene services;
(10) applying pit and fissure sealants; [and]
(11) applying desensitizing agents to the teeth[.];
(12) placing and removing temporary restorations;
(13) making assessments of the oral and maxillofacial area as an aid to diagnosis by the dentist;
(14) taking impressions for study casts. Study casts shall mean only such casts as will be used for purposes of diagnosis and treatment planning by the dentist and for the purposes of patient education; and
(15) providing dental health care case management and care coordination services, which shall include, but not be limited to:
(i) community outreach;
(ii) improving oral outcomes;
(iii) improving access to dental care by assisting people in establishing an ongoing relationship with a dentist, in order to promote the comprehensive, continuous and coordinated delivery of all aspects of oral health care; and
(iv) assisting people to obtain dental health care.
3. Subdivision (c) of section 61.9 of the Regulations of the Commissioner of Education is amended, effective January 1, 2015, to read as follows:
(c) The following services may be performed only under the personal supervision of a licensed dentist:
(1) . . .
(2) . . .
[(3) taking impressions for study casts. Study casts shall mean only such casts as will be used for purposes of diagnosis and treatment planning by the dentist and for the purposes of patient education;]
[(4)] (3) placing or removing matrix bands;
[(5)] (4) applying a topical medication not related to a complete dental prophylaxis;
[(6)] (5) placing and removing periodontal dressings;
[(7)] (6) selecting and prefitting provisional crowns;
[(8)] (7) selecting and prefitting orthodontic bands;
[(9)] (8) removing orthodontic arch wires and ligature ties;
[(10)] (9) taking impressions for space maintainers, orthodontic appliances, and occlusal guards;
[(11)] (10) placing and removing temporary separating devices; and
[(12)] (11) placing orthodontic ligatures.
4. Subdivision (e) of section 61.9 of the Regulations of the Commissioner of Education is amended, effective January 1, 2015, to read as follows:
(e) In accordance with section 29.1(b)(9) and (10) of this Title, a licensed dental hygienist performing services under the supervision of a licensed dentist or pursuant to a collaborative arrangement as defined in subdivision (f) of this section is not permitted to provide dental services or dental supportive services that the licensed dental hygienist knows or has reason to know that he or she is not competent to perform, and a licensed dentist is not permitted to delegate to a licensed dental hygienist dental services or dental supportive services that the licensed dentist knows or has reason to know that the licensed dental hygienist is not qualified by training, experience or by licensure to perform.
5. Subdivision (f) of section 61.9 of the Regulations of the Commissioner of Education is added, effective January 1, 2015, to read as follows:
(f) Collaborative arrangement.
(1) Definitions. As used in this subdivision:
(i) Collaborative arrangement shall mean an agreement between a registered dental hygienist working for a hospital and a licensed and registered dentist who has a formal relationship with the same hospital.
(ii) Hospital shall mean a hospital as defined by Public Health Law section 2801(1).
(2) Requirements. A registered dental hygienist providing services pursuant to a collaborative arrangement shall:
(i) only provide those services that may be provided under general supervision as specified in subdivision (b) of this section, provided that the physical presence of the collaborating dentist is not required for the provision of such services;
(ii) instruct individuals to visit a licensed dentist for comprehensive examination or treatment;
(iii) possess and maintain certification in cardiopulmonary resuscitation in accordance with the requirements for dentists set forth in section 61.19 of this Part and the following:
(a) At the time of his or her registration renewal, the dental hygienist shall attest to having met the cardiopulmonary resuscitation requirement or attest to meeting the requirements for exemption as defined in clause (b) of this subparagraph.
(b) A dental hygienist may be granted an exemption to the cardiopulmonary resuscitation requirement if he or she is physically incapable of complying with the requirements of this subparagraph. Documentation of such incapacity shall include a written statement by a licensed physician describing the dental hygienist’s physical incapacity. The dental hygienist shall also submit an application to the department for exemption which verifies that another individual will maintain certification and be present at the location where the dental hygienist provides dental hygiene services, pursuant to a collaborative arrangement, while the dental hygienist is treating patients.
(c) Each dental hygienist shall maintain for review by the department records of compliance with the cardiopulmonary resuscitation certification requirement, including the dental hygienist’s cardiopulmonary resuscitation certification card; and
(iv) provide collaborative services only pursuant to a written agreement that is maintained in the practice setting of the dental hygienist and collaborating dentist. Such written agreement shall include:
(a) provisions for:
(1) referral and consultation;
(2) coverage for emergency absences of either the dental hygienist or collaborating dentist;
(3) resolution of disagreements between the dental hygienist and collaborating dentist regarding matters of treatment, provided that, to the extent a disagreement cannot be resolved, the collaborating dentist’s treatment shall prevail;
(4) the periodic review of patient records by the collaborating dentist; and
(5) such other provisions as may be determined by the dental hygienist and collaborating dentist to be appropriate; and
(b) protocols, which may be updated periodically, identifying the services to be performed by the dental hygienist in collaboration with the dentist and reflecting accepted standards of dental hygiene. Protocols shall include provisions for:
(1) case management and care coordination, including treatment;
(2) appropriate recordkeeping by the dental hygienist; and
(3) such other provisions as may be determined by the dental hygienist and collaborating dentist to be appropriate.
(3) Collaborative arrangements shall not supersede any law or regulation which requires identified services to be performed under the personal supervision of a dentist.
Text of proposed rule and any required statements and analyses may be obtained from:
Kirti Goswami, State Education Department, Office of Counsel, State Education Building, Room 148, 89 Washington Ave., Albany, NY 12234, (518) 474-6400, email: legal@mail.nysed.gov
Data, views or arguments may be submitted to:
Office of the Professions, Office of the Deputy Commissioner, State Education Department, State Education Building, 2M, 89 Washington Ave., Albany, NY 12234, (518) 486-1765, email: opdepcom@mail.nysed.gov
Public comment will be received until:
45 days after publication of this notice.
Regulatory Impact Statement
1. STATUTORY AUTHORITY:
Section 207 of the Education Law grants general rule-making authority to the Board of Regents to carry into effect the laws and policies of the State relating to Education.
Section 6504 of the Education Law authorizes the Board of Regents to supervise the admission to and regulation of the practice of the professions.
Paragraph (a) of subdivision (2) of section 6507 of the Education Law authorizes the Commissioner of Education to promulgate regulations in administering the admission to and the practice of the professions.
Subdivision (1) of section 6606 of the Education Law, as amended by Chapter 239 of the Laws of 2013, defines the practice of dental hygiene and allows registered dental hygienists, working for a hospital, as defined in Article 28 of the Public Health Law (Article 28 hospital), pursuant to a collaborative arrangement with a New York State licensed and registered dentist, who has a formal relationship with the same hospital, to provide dental services that are currently provided under the general supervision of a dentist, without requiring the physical presence of the collaborating dentist during the provision of such services. Subdivision (2) of section 6606 of the Education Law further authorizes the Commissioner of Education to promulgate regulations defining the functions a dental hygienist may perform that are consistent with the training and qualifications for a license as a dental hygienist.
Section 6608 of the Education Law, as amended by Chapter 239 of the Laws of 2013, allows dental supportive services to be provided by a registered dental hygienist working for an Article 28 hospital under a collaborative arrangement with a licensed and registered dentist, who has a formal relationship with the same hospital.
Subdivision (10) of section 6611 of the Education Law, as amended by Chapter 239 of the Laws of 2013, requires dentists and registered dental hygienists working for an Article 28 hospital, pursuant to a collaborative arrangement with a licensed and registered dentist, who has a formal relationship with the same hospital, to become certified in cardiopulmonary resuscitation (CPR) and maintain this certification, which shall be included in the mandatory continuing education hours requirement acceptable for dentists to the extent provided in regulations of the Commissioner of Education. Subdivision (10) of section 6611 of the Education Law also provides for an exemption to this requirement if the dentist or dental hygienist is physically incapable of performing CPR, as long as the dentist or dental hygienist makes arrangements for another individual in the office to administer CPR.
2. LEGISLATIVE OBJECTIVES:
The proposed rule is necessary to implement Chapter 239 of the Laws of 2013. Consistent with the authority provided by Chapter 239 and the aforementioned statutes, the proposed rule establishes requirements to allow registered dental hygienists, working for an Article 28 hospital, pursuant to a collaborative arrangement with a New York State licensed and registered dentist, who has a formal relationship with the same hospital, to provide dental services that are currently provided under the general supervision of a dentist, without requiring the physical presence of the collaborating dentist during the provision of such services.
3. NEEDS AND BENEFITS:
The proposed rule is necessary to implement Chapter 239 of the Laws of 2013. The purpose of the proposed rule is to provide greater access for New Yorkers to receive important dental services, such as, but not limited to, teeth cleaning, fluoride applications, varnishes, sealants, x-rays and patient education, by establishing the requirements for collaborative arrangements, which will allow registered dental hygienists working for Article 28 hospitals, which include community health centers, hospital based dental clinics, local health department dental clinics, and nursing homes to provide dental services that are currently provided under the general supervision of a dentist, without requiring the physical presence of the collaborating dentist during the provision of such services.
Specifically, the proposed rule establishes the requirements for collaborative arrangements, which include the requirement that collaborative services can only be provided by a dental hygienist pursuant to a written agreement, which must be maintained in the practice setting of the dental hygienist and the collaborating dentist. The proposed rule also establishes requirements regarding the types of provisions that must be included in this written agreement.
The proposed rule requires a dental hygienist, providing services pursuant to a collaborative arrangement, to possess and maintain certification in cardiopulmonary resuscitation (CPR) and to maintain, for review by the Department, records of compliance with this requirement, including his or her CPR certification card. The proposed rule also establishes requirements for an exemption to this CPR certification requirement.
The proposed rule further modifies certain regulatory provisions relating to the general and personal supervision of dental hygienists by dentists, as these provisions required clarification.
4. COSTS:
(a) Costs to State government: The proposed rule implements statutory requirements and establishes standards as directed by statute, and will not impose any additional costs on State government beyond those imposed by statute.
(b) Costs to local government: There are no additional costs to local governments.
(c) Cost to private regulated parties. The proposed rule does not impose any additional costs on regulated parties beyond those imposed by statute. The proposed rule permits, but does not require, any registered dental hygienist to practice pursuant to collaborative arrangements. With respect to registered dental hygienists seeking to practice pursuant to collaborative arrangements, the rule does not impose any additional costs beyond those required by statute. There may be minimal costs to dental hygienists in complying with the CPR certification, record keeping and documentation requirements in the proposed section 61.9(f) of the Commissioner’s Regulations.
(d) Cost to the regulatory agency: The proposed rule does not impose any additional costs on the Department beyond those imposed by statute.
5. LOCAL GOVERNMENT MANDATES:
The proposed rule implements the requirements of Chapter 239 of the Laws of 2013 relating to the practice and regulation of dental hygiene pursuant to collaborative arrangements and does not impose any programs, service, duty, or responsibility upon local governments.
6. PAPERWORK:
The proposed rule requires that a dental hygienist can only provide collaborative services pursuant to a written agreement that is maintained in the practice setting of the dental hygienist and the collaborating dentist. This required written agreement must include provisions for referral and consultation; coverage for emergency absences of either the dental hygienist or collaborating dentist; resolution of disagreements between the dental hygienist and collaborating dentist regarding matters of treatment; and the periodic review of patient records by the collaborating dentist. The proposed rule further requires the written agreement to include protocols, which may be updated periodically, identifying the services to be performed by the dental hygienist in collaboration with the dentist and that reflect accepted standards of dental hygiene. These protocols must include provisions for case management and care coordination, including treatment; and appropriate recordkeeping by the dental hygienist. The proposed rule also provides that the written agreement may include any other provisions, including provisions relating to protocols, that the dental hygienist and collaborating dentist determine to be appropriate. Additionally, the proposed rule requires each dental hygienist to maintain, for review by the Department, records of compliance with the CPR certification requirement, including his or her CPR certification card.
7. DUPLICATION:
The proposed rule is necessary to implement Chapter 239 of the Laws of 2013 and does not duplicate other existing state or federal requirements.
8. ALTERNATIVES:
The proposed rule is necessary to implement Chapter 239 of the Laws of 2013. There are no significant alternatives to the proposed rule and none were considered.
9. FEDERAL STANDARDS:
Since there are no applicable federal standards for dental hygienists, the proposed rule does not exceed any minimum federal standards for the same or similar subject areas.
10. COMPLIANCE SCHEDULE:
The proposed rule is necessary to implement Chapter 239 of the Laws of 2013, which becomes effective January 1, 2015. It is anticipated that registered dental hygienists working in Article 28 hospitals seeking to provide dental services pursuant to a collaborative arrangement with a licensed and registered dentist, who has a formal relationship with the same hospital, will be able to comply with the proposed rule by the effective date.
Regulatory Flexibility Analysis
The proposed rule implements the requirements of Chapter 239 of the Laws of 2013 by establishing requirements to allow a dental hygienist working for a hospital, as defined by Article 28 of the Public Health Law (Article 28 hospital), pursuant to a collaborative arrangement with a licensed and registered dentist, who has a formal relationship with the same Article 28 hospital, to provide certain dental services that are currently provided under the general supervision of a dentist, as defined in subdivision (b) of section 61.9 of the Regulations of the Commissioner of Education, without requiring the physical presence of the collaborating dentist during the provision of such services. Article 28 hospitals include community health centers, hospital-based dental clinics, local health department dental clinics, and nursing homes, all of which are overseen and regulated by the New York State Department of Health. The proposed rule will not impose any new reporting, recordkeeping, or other compliance requirements, or have an adverse economic impact, on small businesses or local governments. Because it is evident from the nature of the proposed rule that it will not adversely affect small businesses or local governments, no affirmative steps were needed to ascertain that fact and none were taken. Accordingly, a regulatory flexibility analysis for small businesses and local governments is not required, and one has not been prepared.
Rural Area Flexibility Analysis
1. TYPES AND ESTIMATED NUMBER OF RURAL AREAS:
The proposed rule would allow a dental hygienist working for a hospital, as defined by Article 28 of the Public Health Law (Article 28 hospital), pursuant to a collaborative arrangement with a licensed and registered dentist, who has a formal relationship with the same Article 28 hospital, to provide certain dental services that are currently provided under the general supervision of a dentist, including those located in the 44 rural counties with less than 200,000 inhabitants and the 71 towns in urban counties with a population density of 150 per square miles or less. Of the approximately 9,813 dental hygienists who are registered to practice in New York State, approximately 791 reported that their permanent address of record is in a rural county of New York State.
2. REPORTING, RECORDKEEPING AND OTHER COMPLIANCE REQUIREMENTS; AND PROFESSIONAL SERVICES:
As required by Chapter 239 of the Laws of 2013, which will become effective January 1, 2015, the proposed rule will allow dental hygienists, who work in Article 28 hospitals, to provide certain dental services, such as, but not limited to, teeth cleaning, fluoride applications, varnishes, sealants, x-rays and patient education, with more autonomy, pursuant to collaborative arrangements with dentists, who have formal relationships with the same hospitals. Article 28 hospitals include community health centers, hospital-based dental clinics, local health department dental clinics, and nursing homes, all of which are overseen and regulated by the New York State Department of Health. The proposed amendments to the introductory paragraph and subdivisions (b), (c) and (e) of section 61.9 of the Regulations of the Commissioner of Education and addition of subdivision (f) to section 61.9 to the Regulations of the Commissioner of Education implement the dental hygiene collaborative arrangement requirements of Chapter 239.
The proposed amendment to the introductory paragraph of 61.9 of the Regulations of the Commissioner of Education establishes that a dental hygienist must practice either under the supervision of a licensed dentist or pursuant to a collaborative arrangement.
The proposed amendments to subdivisions (b) and (c) of section 61.9 of the Regulations of the Commissioner of Education modify provisions relating to the general and personal supervision of dental hygienists by dentists, as these provisions required clarification.
The proposed amendment to subdivision (e) of section 61.9 of the Regulations of the Commissioner of Education establishes that a dental hygienist performing services pursuant to a collaborative arrangement is not permitted to provide dental services or dental supportive services that the licensed dental hygienist knows or has reason to know that he or she is not competent to perform, and a licensed dentist is not permitted to delegate to a licensed dental hygienist dental services or dental supportive services that the licensed dentist knows or has reason to know that the licensed dental hygienist is not qualified by training, experience or by licensure to perform.
The proposed addition of subdivision (f) to section 61.9 of the Regulations of the Commissioner of Education establishes the requirements for collaborative arrangements, which include authorizing a registered dental hygienist providing services, pursuant to such an arrangement, to only provide those services that may be provided under the general supervision of a dentist as defined in subdivision (b) of section 61.9 of the Regulations of the Commissioner of Education, without requiring the physical presence of the collaborating dentist during the provision of such services.
In addition, the proposed rule requires dental hygienists to instruct individuals to visit a licensed dentist for comprehensive examination or treatment.
The proposed rule further requires dental hygienists, providing services pursuant to a collaborative arrangement, to possess and maintain certification in cardiopulmonary resuscitation (CPR) and to attest, at the time of his or her registration renewal, that he or she meets the CPR certification requirement or the requirements for an exemption to it. The proposed rule establishes the following requirements for the CPR certification requirement exemption: (a) the dental hygienist must be physically incapable of complying with the CPR certification requirement and have a written statement by a licensed physician describing his or her physical incapacity; and (b) he or she must submit an application for exemption to the Department that verifies that another individual will maintain CPR certification and be physically present at the location where the dental hygienist provides dental services, pursuant to a collaborative arrangement, while the dental hygienist is treating patients.
The proposed rule also requires each dental hygienist to maintain, for review by the Department, records of compliance with the CPR certification requirement, including his or her CPR certification card.
Moreover, the proposed rule provides that a dental hygienist can only provide collaborative services pursuant to a written agreement that is maintained in the practice setting of the dental hygienist and the collaborating dentist. This required written agreement must include provisions for referral and consultation; coverage for emergency absences of either the dental hygienist or collaborating dentist; resolution of disagreements between the dental hygienist and collaborating dentist regarding matters of treatment; and the periodic review of patient records by the collaborating dentist. The proposed rule further requires the written agreement to include protocols, which may be updated periodically, identifying the services to be performed by the dental hygienist in collaboration with the dentist and that reflect accepted standards of dental hygiene. These protocols must include provisions for case management and care coordination, including treatment; and appropriate recordkeeping by the dental hygienist. The proposed rule also provides that the written agreement may include any other provisions, including provisions relating to protocols, that the dental hygienist and collaborating dentist determine to be appropriate.
3. COSTS:
The proposed rule will not require any registered dental hygienist to practice pursuant to collaborative arrangements. With respect to registered dental hygienists seeking to practice pursuant to collaborative arrangements, including those in rural areas, the rule does not impose any additional costs beyond those required by statute. There may be minimal costs to dental hygienists in complying with the CPR certification, record keeping and documentation requirements in the proposed addition of subdivision (f) to section 61.9 of the Regulations of the Commissioner of Education.
4. MINIMIZING ADVERSE IMPACT:
The proposed rule is necessary to implement Chapter 239 of the Laws of 2013. The statutory requirements do not make exceptions for individuals who live or work in rural areas. Thus, the Department has determined that the proposed rule’s requirements should uniformly apply to all dental hygienists registered in New York State, who seek to practice pursuant to collaborative arrangements. Because of the nature of the proposed rule, alternative approaches for rural areas were not considered.
5. RURAL AREAS PARTICIPATION:
Comments on the proposed rule were solicited from statewide organizations representing all parties having an interest in the practice of dental hygienists. These organizations included the Council for Hospital Dentistry, Office of Persons with Developmental Disabilities, Community Health Center Association of New York, Area Health Education Centers, Rural Health Association and professional associations representing the dental hygiene profession, dental hygiene educators and the dentistry professions. These groups have members who live or work or provide dental hygiene education in rural areas.
6. INITIAL REVIEW OF RULE (SAPA § 207):
Pursuant to State Administrative Procedure Act section 207(1)(b), the State Education Department proposes that the initial review of this rule shall occur in the fifth calendar year after the year in which the rule is adopted, instead of in the third calendar year. The justification for a five year review period is that the proposed rule is necessary to implement the statutory requirements of Chapter 239 of the Laws of 2013, and, therefore, the substantive provisions of the proposed rule cannot be repealed or modified unless there is a further statutory change. Accordingly, there is no need for a shorter review period. The Department invites public comment on the proposed five year review period for this rule. Comments should be sent to the agency contact listed in item 10 of the Notice of Proposed Rule Making published herewith, and must be received within 45 days of the State Register publication date of the Notice.
Job Impact Statement
The proposed rule implements Chapter 239 of the Laws of 2013 by establishing requirements to allow dental hygienists working for hospitals, as defined by Article 28 of the Public Health, pursuant to a collaborative arrangement with a licensed and registered dentist, who has a formal relationship with the same hospital, to provide dental services that are currently provided under the general supervision of a dentist, without requiring the physical presence of the collaborating dentist during the provision of such services. The proposed rule also requires that a dental hygienist can only provide collaborative services pursuant to a written agreement, which must be maintained in the practice setting of the dental hygienist and the collaborating dentist. The proposed rule requires that this written agreement include provisions for referral and consultation; coverage for emergency absences of either the dental hygienist or collaborating dentist; resolution of disagreements between the dental hygienist and collaborating dentist regarding matters of treatment; and the periodic review of patient records by the collaborating dentist. The proposed rule further requires this written agreement to include protocols, identifying the services to be performed by the dental hygienist in collaboration with the dentist, which must reflect accepted standards of dental hygiene, as well as provisions for case management and care coordination, including treatment; and appropriate recordkeeping by the dental hygienist.
The proposed rule requires a dental hygienist, providing services pursuant to a collaborative arrangement, to possess and maintain certification in cardiopulmonary resuscitation (CPR) and to maintain, for review by the Department, records of compliance with this requirement, including his or her CPR certification card. The proposed rule also establishes requirements for an exemption to this CPR requirement.
The proposed rule further modifies certain regulatory provisions relating to the general and personal supervision of dental hygienists by dentists, as these provisions required clarification.
Since the proposed rule implements specific statutory requirements and directives, any impact on jobs and employment opportunities created by establishing requirements for the practice of dental hygiene pursuant to collaborative arrangements is attributable to the statutory requirement, not the proposed rule, which simply establishes standards that conform to the requirements of the statute.
The proposed rule will not have a substantial adverse impact on jobs or employment opportunities. Because it is evident from the nature of the proposed rule that it will not affect job and employment opportunities, no affirmative steps were needed to ascertain that fact and none were taken. Accordingly, a job impact statement is not required and one has not been prepared.
