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PA Bulletin, Doc. No. 21-79

RULES AND REGULATIONS

Title 49—PROFESSIONAL AND VOCATIONAL STANDARDS

STATE BOARD OF DENTISTRY

[ 49 PA. CODE CH. 33 ]

Public Health Dental Hygiene Practitioner Practice Sites

[51 Pa.B. 304]
[Saturday, January 16, 2021]

 The State Board of Dentistry (Board) hereby amends § 33.205b (relating to practice as a public health dental hygiene practitioner), to read as set forth in Annex A.

Effective Date

 The amendments will be effective upon publication of this final-form rulemaking in the Pennsylvania Bulletin.

Statutory Authority

 Section 3(o) of the Dental Law (act) (63 P.S. § 122(o)) authorizes the Board to adopt, promulgate and enforce rules and regulations as may be deemed necessary by the Board to carry out the provisions of the act. Section 11.9(b)(10) of the act (63 P.S. § 130j(b)(10)) authorizes the Board to determine other locations at which public health dental hygiene practitioners may practice.

Background and Purpose

 On January 4, 2016, the act of November 4, 2015 (P.L. 225, No. 60) (Act 60 of 2015) became effective, amending section 11.9 of the act to allow the Board to add other ''locations'' it deems appropriate for practice by public health dental hygiene practitioners in addition to those enumerated by the General Assembly. Prior to this amendment, subsection (b)(10) permitted the Board to add other ''institutions'' it deemed appropriate. On March 3, 2016, the Pennsylvania Dental Hygienists' Association (PDHA) petitioned the Board, seeking amendments to the regulations to include additional practice sites for public health dental hygiene practitioners. Specifically, the PDHA asked the Board to consider adding the following locations: private settings of hospice and home-bound patients; primary care settings, especially pediatric settings; and childcare settings. The Board developed the proposed rulemaking in response to the PDHA's petition. The proposed rulemaking sought to clarify the acceptable practice sites included within the definition of ''health care facilities'' under section 802.1 of the Health Care Facilities Act (35 P.S. § 448.802a); expand the locations at which a public health dental hygiene practitioner may practice beyond just ''personal care homes'' to include other ''facilities'' regulated by the Department of Human Services as defined in section 1001 of the Human Services Code (62 P.S. § 1001); and add as an acceptable practice site an office or clinic of a physician. These additional sites were meant to expand access to dental hygiene services, oral health education and referrals to dentists as authorized by Act 60 of 2015.

Summary of Comments to the Proposed Rulemaking; the Board's Response and Description of Amendments to the Final-form Rulemaking

 Notice of proposed rulemaking was published at 49 Pa.B. 1396 (March 23, 2019). Publication was followed by a 30-day public comment period. The Board received numerous comments from different state and National organizations and individual licensees, both dentists and dental hygienists, throughout this Commonwealth. Public health dental hygiene practitioners, and dental hygienists uniformly advocated in favor of the regulation, while dentists and other representative groups expressed opposition. In addition, the Independent Regulatory Committee (IRRC) reviewed the proposed rulemaking and provided comments and recommendations. The Board also received comments from the House Professional Licensure Committee (HPLC). The Board did not receive any comments from the Senate Consumer Protection and Professional Licensure Committee (SCP/PLC). To effectively address all the comments, the Board has categorized them by topic.

Public comments

 A common concern among dentists is that parents will falsely believe that if their children have been seen by a public health dental hygiene practitioner (PHDHP) in offices of pediatricians or primary care physicians, they will have a false sense of security that their children have had adequate quality comprehensive dental care and will not take their children to a dentist. There were also were many questions about how the PHDHP will ensure that patients make a referral appointment with a dentist or if the patient will even follow through with the referral to a dentist when they are already receiving cleanings at their primary care physician's office. Other dentists opined that the regulation contains no language that limits PHDHP's location of practice to economically depressed, dentally underserved areas, and that expanding practice to physicians' offices does not necessarily provide additional access to care because physicians can locate their practice where they see fit, including high-access or affluent areas of the State.

 The Board recognizes that pediatric medical offices and other primary care settings see populations that need the most preventive oral health care on a regular basis for well-child visits. The Board therefore believes that medical offices are the perfect setting to deliver safe and effective oral hygiene education and preventive services to underserved areas. The Board further believes that this additional site will expand access to oral health care and education by public health dental hygiene practitioners and will assist patients, particularly pediatric patients, find a ''dental home'' by way of the annual referral to a dentist. However, the Board agrees that simply expanding practice to physicians' offices does not necessarily provide additional access to dental care because physicians can locate their practice where they see fit. The Board also agrees that economically depressed, underserved areas are those that are most lacking in access to oral health care. After careful deliberation, the Board's final-form rulemaking adds language to § 33.205b(c)(11) to clarify that PHDHPs may perform dental hygiene services without the supervision of a dentist in an office or clinic of a physician, including a satellite location/operation, that is located in a dental health professional shortage area, as determined by the United States Department of Health and Human Services, Health Resources & Services Administration. The Pennsylvania Department of Health publishes a list of dental health professional shortage areas in this Commonwealth on its web site, and the Board will include a link to that list on its web site. The Board believes that expanding the practice sites to offices or clinics of a physician, but limiting these locations to those in dental health professional shortage areas, is a fair compromise that takes into consideration concerns expressed by opponents to this final-form rulemaking, while increasing access to quality oral health care to those who might not be able to obtain services from a traditional dental setting.

 The Board appreciates that many opponents of this final-form rulemaking question how the PHDHP will ensure that patients make a referral appointment with a dentist. But that concern is true with any practice site at which the professional practice of a PHDHP is currently permitted, including those sites already authorized in the Dental Law, and those sites added by this final-form rulemaking. Frankly, there is no way for a PHDHP to ensure that a patient follows through with any referral. However, by providing a patient with oral hygiene education and services and a referral to a dental home, the PHDHP is providing preventative care, services and information to individuals who may never receive it otherwise.

 Some commenters suggested that patients will likely not show for their dental appointments and that parents may not understand the difference between a screening performed by a PHDHP and a comprehensive exam performed by a dentist. This, too, is true of any practice site at which the professional practice of a PHDHP is permitted. It is the responsibility of the PHDHP providing the preventative care and screenings to inform the patients and their guardians of their role as a PHDHP. Further, the Board's regulations already require a PHDHP to refer each patient to a licensed dentist on an annual basis. Documentation of this annual referral must be maintained in the dental record for each patient. While a PHDHP may choose not to refuse services to a patient who has failed to follow through with the referral, a yearly reminder to see a dentist is better than no reminder at all. Contrary to a commonly expressed concern, the PHDHP will not be reassuring patients that it is not necessary to see a dentist.

 Others commented that PHDHPs are not trained as extensively as a dentist or a nurse practitioner and, as a result, pathology, caries, and malocclusion may be overlooked or misdiagnosed, and patient care will suffer. A similar concern is that yearly cleanings and preventative care could cause patients to be even more delayed in seeking dental care and could result in higher instances of emergency treatments. The Board recognizes that many low-income patients need services that a PHDHP cannot provide; however, a PHDHP is generally a dental hygiene graduate of a dental hygiene program accredited by the American Dental Association's Commission on Dental Accreditation (CODA). The CODA standard (Standard 2-8) for dental hygiene curricula includes content in four areas: general education, biomedical sciences, dental sciences and dental hygiene sciences. General education content must include oral and written communications, psychology and sociology. Biomedical science content must include content in anatomy, physiology, chemistry, biochemistry, microbiology, immunology, general and maxillofacial pathology or pathophysiology, or both, nutrition and pharmacology. Dental sciences content must include tooth morphology, head, neck and oral anatomy, oral embryology and histology, oral pathology, radiography, periodontology, pain management and dental materials. Finally, dental hygiene science content must include oral health education and preventive counseling, health promotion, patient management, clinical dental hygiene, provision of services for and management of patients with special needs, community dental/oral health, medical and dental emergencies, infection and hazard control management, and the provision of oral health care services to patients with bloodborne infectious diseases. In addition, a PHDHP must have completed at least 3,600 hours of practice under the supervision of a licensed dentist. A PHDHP can certainly educate the public on the importance of oral health and connect them to a dental home. PHDHPs are already required to refer each patient to a licensed dentist on an annual basis so that the dentist can provide diagnosis of dental disease, radiographic examination, oral cancer screening and treatment, along with other dental care or referral to other dental specialists.

 Some commenters opined that the Board's proposed rulemaking is inconsistent with the American Academy of Pediatric Dentistry's (AAPD) goal of establishment of a ''dental home'' for all children by 1 year of age. These same individuals commented that the proposed rulemaking is inconsistent with AAPD's policy on ''Maintaining and Improving the Oral Health of Young Children,'' because by allowing a hygienist to function independently in a pediatrician's office, the concept of a dental home is broken. The Board's response to this comment is that by allowing PHDHPs to offer preventative care in primary care physicians' offices with an annual referral to a dentist office, will at least raise awareness to children and their parents of the need to secure a dental home. PHDHPs are already practicing in elementary and secondary schools in a way that is consistent with AAPD's goal of establishing a dental home and policies on ''Maintaining and Improving the Oral Health of Young Children.'' Expanding the practice sites to physicians' offices that are located in a dental health professional shortage area will reach more children and allow them to receive preventative care and yearly referrals to licensed dentists that they might not otherwise receive.

 Some commenters expressed concern that the Board's proposed rulemaking is not in the best interest of patients, opining that unsupervised hygienists will not protect the public and will limit additional access to address unmet dental needs. However, PHDHPs are already permitted to practice unsupervised. Inter-professional care is becoming a standard. Pediatric medical offices and other primary care settings see populations that need the most preventive oral health care on a regular basis for well-child visits. The Board agrees with the PDHA that these medical offices are ''a perfect setting to deliver safe and effective oral hygiene education and services,'' to the neediest of populations. The inclusion of these new locations will improve access to oral health care in this Commonwealth and will improve the oral health of citizens of this Commonwealth.

 The Board emphasizes that this final-form rulemaking only expands the practice sites in which the PHDHPs can practice. The scope of practice for PHDHPs, as well as their ability to practice unsupervised, already exists. Therefore, many of the comments received, such as the level of training for PHDHPs, the scope of practice of PHDHPs, the placement of sealants, supervision of PHDHPs, or the inability of PHDHPs to diagnose or treat patients or take radiographs are outside the scope of this final-form rulemaking. The Board agrees that early detection of dental problems is crucial. PHDHPs are permitted to take radiographs as outlined in § 33.302(a) (relating to requirements for personnel performing radiologic procedures) and must provide to the patient a copy of the radiograph and a referral to a dentist indicating the reason the radiograph was taken and any observations made by the PHDHP. The dentist can then read the radiograph and make a diagnosis for comprehensive care, including restorations for caries and extractions or referrals to dental specialists such as orthodontists, periodontists, oral surgeons or endodontists. It is the licensed dentists who will provide medication that PHDHPs cannot prescribe.

 Some commenters question how the Board will know that the standard of care is being met by PHDHPs when there is no dental supervision with dental expertise. The Board responds, again, that the authority allowing PHDHPs to practice independently already exists. By statutory definition a PHDHP who has satisfied the requirements of section 11.9 of the act ''may perform educational, preventive, therapeutic and intra-oral procedures which the hygienist is educated to perform and which require the hygienist's professional competence and skill but which do not require the professional competence and skill of a dentist without the authorization, assignment or examination of a dentist.'' 63 P.S. § 121. It is the responsibility of the PHDHP to follow the Board's regulations relating to their practice and the standard of care. If a PHDHP's treatment falls below the acceptable standard of care, a complaint can be made with the Board in the same manner that complaints are made against dentists or any other licensees. Every complaint is investigated and prosecuted when appropriate. Like dentists and other licensees, PHDHPs may face disciplinary actions against their license such as public reprimand, probation, suspension, revocation or the imposition of monetary civil penalties.

 Many reviewers questioned whose malpractice insurance will pay should something go wrong when being treated by a PHDHP? The Board's response to these inquiries is that section 11.9 of the act and the Board's regulations in § 33.116 (relating to certification of public health dental hygiene practitioners) require PHDHPs to provide the Board with documentation demonstrating that they obtained professional liability insurance or are a named insured governed by a group policy in the amount of $1 million per occurrence and $3 million per annual aggregate. If something were to occur while the PHDHP is treating a patient, the patient would be covered by the PHDHP's professional liability insurance.

 Many commenters questioned, if PHDHP practice sites are expanded to include physician's offices, what are the responsibilities of physicians employing PHDHPs, and what oversight or supervision must the physician provide to the PHDHP? While dental hygienists are required to work under the supervision of a dentist, PHDHPs are not. It follows that a PHDHP who is working in a physician's office is not required to work under the supervision of the physician. While the physician may choose to have an employer/employee relationship or an employer/independent contractor relationship with the PHDHP, that is up to the parties to determine independently. Therefore, the Board will not be regulating the relationship between the PHDHP and the physician.

 Similarly, some individuals questioned to what extent the Board will oversee issues that could arise in the physician's offices, such as disciplinary actions, which are otherwise regulated by the Medical Board. The Board regulates the practice of PHDHPs; therefore, if a PHDHP commits a violation of the act or regulations, regardless of practice site, the PHDHP is subject to disciplinary action by the Board.

 One commenter questioned whether it is voluntary for a physician to employ a PHDHP, and will the Board play a role in approving these arrangements or otherwise reviewing the terms and conditions between the physician and the PHDHP. As discussed previously, it is up to the parties to establish what type of employment relationship, if any, they choose to have. They might not choose to have an employment relationship. A PHDHP might opt to lease space in a physician's office and work as an independent contractor. A physician will not be forced to employ a PHDHP, as neither the Board's regulations nor the regulations of the State Board of Medicine or the State Board of Osteopathic Medicine (medical boards) mandate that arrangement.

 Several comments/questions were received concerning billing and insurance. One concern was that most dental plans allow for a cleaning every 6 months, and if a patient is receiving a cleaning at the primary care physician's office, how can a dentist then examine the patient within this 6-month period? Similarly, many licensees seem to be concerned that expanding practice sites this far will create a Statewide workforce conflict with two workforce groups fighting for reimbursement from the same pool of resources instead of working together. There are also concerns that the dental community will view a hygienist as a fee for service competitor because hygienists will be billing insurance for cleanings and sealants without ever diagnosing anything. However, as previously mentioned, this is what PHDHPs do now. PHDHPs are already authorized to provide these services outside of dental offices in daycares and schools, correctional facilities, health care facilities, personal care homes, older adult daily living centers, and Federally qualified health centers, and so forth. This final-form rulemaking simply expands the PHDHPs practice sites as authorized by section 11.9 of the act. Moreover, the Board does not regulate billing. The Board recognizes that it may not be ideal for dentists to perform examinations when an oral prophylaxis was not completed immediately prior to the examination; however, the goal of this final-form rulemaking is to provide preventive oral health care on a regular basis to this Commonwealth's neediest population and to then refer these patients to a dental home. The anticipation is that patients, who otherwise would not seek dental care for themselves or their children, will seek dental care at the advice of PHDHPs.

 Many individuals provided alternative suggestions to this final-form rulemaking such as offering incentives to dentists who offer low cost or free services to the underserved population. Some suggestions were to provide dental loan forgiveness or tax credit. While these suggestions are laudable, the General Assembly is more equipped to respond to these urgings. The Board is without authority to extend dental loan forgiveness or tax credits to dentists who offer low cost services to underserved populations. The Board does, however, have authority to expand the practice sites for PHDHPs to locations the Board deems appropriate. The Board feels strongly that expanding the practice sites to areas where PHDHPs can provide preventative oral care and hygiene education services to this Commonwealth's neediest populations, is in the public's best interest.

 Other suggestions included adding a uniform referral form with specific language that the PHDHP is not a licensed dentist and that the care provided by the PHDHP does not replace the need for a comprehensive dental examination with a licensed dentist. It was further suggested that this uniform referral form should provide contact information for local dentist offices or community resources that can provide dental examinations and specifically recommend that the patient schedule dental services with a licensed dentist. The Board believes that the implementation of a uniform referral form would exceed the scope of this final-form rulemaking, which is limited to the practice sites at which a PHDHP may practice. However, the Board is not opposed to considering this suggestion as part of a future rulemaking and will take it under advisement. In the meantime, the referral process for PHDHPs is already clearly outlined in the Board's existing regulations. Section 33.205b(b) currently provides that PHDHPs shall refer each patient to a licensed dentist on an annual basis. In addition, PHDHPs are required to document the referral in the patient's dental record. To date, there have not been reported issues with referrals by PHDHPs to dental offices. The reality is that with or without a uniform referral form, PHDHPs cannot force patients to follow through and see a dentist. However, the PHDHP can and should emphasize the need for regular dental care.

 Last, the Board received numerous comments about in-home treatment by PHDHPs. Commentators opined that it is inherently risky because patients who need in-home attention generally have extreme physical and medical complications. Many licensees and organizations expressed concern that these patient's lives should not be put in the hands of someone who lacks emergency care training, basic life support and the availability of an AED or medical kit which would have restricted drugs. The Board agrees that in-home treatment by PHDHPs is inherently risky due to the compromised health that these patients often have. The Board notes that PHDHPs, like dentists, are required, as a condition of biennial licensure renewal, to provide proof of current certification to administer cardiopulmonary resuscitation. However, in response to these comments, the Board has deleted from § 33.205b(c) the language originally proposed in paragraph (3)(iii), which added as an acceptable practice location for PHDHPs ''services provided by a health care facility to patients in their places of residence or other independent living environment.''

Comments from the HPLC

 The HPLC questioned whether the term ''mental health establishment'' includes drug and alcohol treatment facilities. If it does not, the HPLC urged the Board to include those facilities. Drug and alcohol treatment facilities are regulated by the Department of Drug and Alcohol Programs (DDAP). Specifically, the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.S. §§ 1690.101—1690.115) references these types of facilities. The term ''facility'' is defined in the DDAP's regulations in 28 Pa. Code § 701.1 (relating to general definitions) as the physical location in which ongoing, structured and systematic drug and alcohol services are delivered. The Board has therefore amended this final-form rulemaking by adding an additional paragraph to subsection (c) to include a ''facility'' as defined in 28 Pa. Code § 701.1, that is licensed by the DDAP to provide drug and alcohol treatment services as an acceptable place of practice for a PHDHP. Those attending drug and alcohol treatment facilities typically do not have access to dental care. The Board agrees that treatment by a PHDHP with an annual referral to a dental office would be beneficial in these facilities.

 Like several of the public commenters, the HPLC further requested clarification regarding the Board's role in regulating the relationship between the PHDHP and the physician when services are provided in a physician's office or clinic. As noted previously, the Board has no role in regulating that relationship. How the PHDHP and the physician structure their relationship is up to them. Physicians located in dentally underserved areas are free to utilize the services of a PHDHP, or not.

Comments from IRRC

 First, IRRC recommended that the Board address the HPLC's comments for IRRC's review as part of their determination of whether this final-form rulemaking is in the public's interest. The Board reviewed the HPLC's comments and addressed them previously.

Subsection (c)(3)(ii)

 IRRC next requested that the Board explain why a birth center was not carried over to the list of examples outlined in § 33.205b(c)(3)(ii) as one of the acceptable practice sites where a PHDHP may perform dental hygiene services. The Board initially did not include a birth center among the examples listed because individuals typically stay in birth centers for a short period of time. However, because of IRRC's concern, the Board has reconsidered its position. The Board recognizes that receiving preventative dental care and other dental hygiene services from a PHDHP soon after the birth of a child is essential as the health of the mother's teeth could have been compromised during the pregnancy. The referral that the new mother would receive to a dentist may also encourage her to obtain a dental home for the new baby in that first year of life. Therefore, this final-form rulemaking reflects ''a birth center'' in the list of examples of acceptable places where a PHDHP may practice.

 IRRC also commented that the phrase, ''or any other facility licensed and regulated by the Department of Health or successor agency'' under subsection (c)(3)(ii), is not a specific example of a facility. IRRC suggested that the Board delete this phrase from the subparagraph and include it as a separate paragraph. Similarly, IRRC suggested that the Board make the same revision to subsection (c)(4)(ii) regarding the phrase ''or any other facility licensed and regulated by the Department of Human Services or a successor agency.'' The Board has made these revisions, which are reflected in this final-form rulemaking. In so doing, the paragraphs in subsection (c) have been renumbered.

Subsection (c)(11)

 With respect to the Board's proposed expansion of PHDHP practice sites to offices and clinics of physicians licensed by the medical boards, IRRC observed that the regulations of the medical boards allow for satellite locations and operations maintained by physician assistants. IRRC therefore questioned whether satellite locations would be considered ''an office or a clinic'' for purposes of this paragraph and suggested that the Board clarify that issue or explain why this is unnecessary. Upon further review, the Board has included language clarifying that an office or clinic of a physician includes ''a satellite location'' as defined in the State Board of Medicine's regulations in § 18.122 (relating to definitions) or ''satellite operations'' as defined in the State Board of Osteopathic Medicine regulations in § 25.142 (relating to definitions). Because there is no supervision required by the physician, a PHDHP can practice in a satellite office or clinic where there is no physician on the premises. Further, under §§ 18.155 and 25.175 (relating to satellite locations; and physician assistants and satellite operations), satellite locations/operations are generally utilized in areas of medical need, so this is consistent with where the PHDHP will be practicing. This final-form rulemaking reflects this change.

Miscellaneous clarity

 IRRC noted that the phrase ''includes, but is not limited to'' appears in § 33.205b(3)(ii) and 4(ii) of the proposed rulemaking, when the Pennsylvania Code & Bulletin Style Manual (Manual) requires in section 6.16 (relating to words and phrases to avoid) that agencies avoid this phrase and use ''includes'' instead. IRRC also noted that the Manual states in section 2.1f (relating to arrangement of Code) that a subdivision may not have two designators. The Board made corrections to this final-form rulemaking consistent with IRRC's comment.

 Last, IRRC recommended that cross-references to the applicable regulations of the medical boards should be added to § 33.205b(c)(11). In response, the Board has added cross references to the relevant statutes governing physicians and included pinpoint citations to the definitions of ''satellite location'' in Chapter 18 (relating to State Board of Medicine—practitioners other than medical doctors) and ''satellite operations'' in Chapter 25 (relating to State Board of Osteopathic Medicine).

Fiscal Impact and Paperwork Requirements

 There are no fiscal impacts or paperwork requirements associated with this final-form rulemaking.

Sunset Date

 The Board continuously monitors the effectiveness of its regulations on a fiscal year and biennial basis. Therefore, no sunset date has been assigned.

Regulatory Review

 Under section 5(a) of the Regulatory Review Act (71 P.S. § 745.5(a)), on March 12, 2019, the Board submitted a copy of the notice of proposed rulemaking, published at 49 Pa.B. 1396, and a copy of a Regulatory Analysis Form to the IRRC and to the Chairpersons of the HPLC and the SCP/PLC for review and comment. A copy of this material is available to the public upon request.

 Under section 5(c) of the Regulatory Review Act, the Board shall submit to IRRC, the HPLC and the SCP/PLC copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Board has considered all comments from IRRC, the HPLC and the public.

 Under section 5.1(g)(3) and (j.2) of the Regulatory Review Act (71 P.S. § 745.5a(g)(3) and (j.2)), on December 2, 2020, the final-form rulemaking was deemed approved by the HPLC and the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, the IRRC met on December 3, 2020, and approved the final-form rulemaking.

Additional Information

 Additional information may be obtained by contact- ing Lisa Burns, Administrator, State Board of Dentist- ry, P.O. Box 2649, Harrisburg, PA 17105-2649, ST-DENTISTRY@PA.GOV.

Findings

 The Board finds that:

 (1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P.L. 769, No. 240) (45 P.S. §§ 1201 and 1202), known as the Commonwealth Documents Law and the regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2 (relating to notice of proposed rulemaking required; and adoption of regulations).

 (2) A public comment period was provided as required by law and all comments were considered in drafting this final-form rulemaking.

 (3) This final-form rulemaking does not include any amendments that would enlarge the scope of the proposed rulemaking published at 49 Pa.B. 1396.

 (4) This final-form rulemaking is necessary and appropriate for administration and enforcement of the act.

Order

The Board orders that:

 (a) The regulations of the Board at 49 Pa. Code Chapter 33, are amended by amending § 33.205b to read as set forth in Annex A.

 (b) The Board shall submit this final-form rulemaking to the Office of General Counsel and to the Office of Attorney General as required by law.

 (c) The Board shall submit this final-from rulemaking to IRRC, the HPLC and the SCP/PLC for approval as required by law.

 (d) The Board shall certify this final-form rulemaking and deposit it with the Legislative Reference Bureau as required by law.

 (e) This final-form rulemaking shall take effect immediately upon publication in the Pennsylvania Bulletin.

R. IVAN LUGO, DMD, 
Chairperson

 (Editor's Note: See 50 Pa.B. 7255 (December 19, 2020) for IRRC's approval order.)

Fiscal Note: Fiscal Note 16A-4633 remains valid for the final adoption of the subject regulations.

Annex A

TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS

PART I. DEPARTMENT OF STATE

Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS

CHAPTER 33. STATE BOARD OF DENTISTRY

Subchapter C. MINIMUM STANDARDS OF CONDUCT AND PRACTICE

§ 33.205b. Practice as a public health dental hygiene practitioner.

 (a) Scope of professional practice. A public health dental hygiene practitioner may perform the dental hygiene services set forth in § 33.205(a)(2)—(6) (relating to practice as a dental hygienist) in the practice settings identified in subsection (c) without the authorization, assignment or examination by a dentist. A public health dental hygiene practitioner may perform the dental hygiene services set forth in § 33.205(a)(1) and (7) in accordance with § 33.205(d).

 (b) Requirement of referral. A public health dental hygiene practitioner shall refer each patient to a licensed dentist on an annual basis. Documentation of the referral must be maintained in the patient's dental record. The failure of the patient to see a dentist as referred will not prevent the public health dental hygiene practitioner from continuing to provide dental hygiene services to the patient within the scope of professional practice set forth in subsection (a).

 (c) Practice settings. A public health dental hygiene practitioner may perform dental hygiene services without the supervision of a dentist in the following practice settings:

 (1) Public and private educational institutions that provide elementary and secondary instruction to school aged children under the jurisdiction of the State Board of Education, and in accordance with all applicable provisions of the Public School Code of 1949 (24 P.S. §§ 1-101—27-2702), the regulations relating to the certification of professional personnel in 22 Pa. Code Chapter 49 (relating to certification of professional personnel), and the regulations of the Department of Health in 28 Pa. Code § 23.35 (relating to dental hygienists).

 (2) Correctional facilities. For purposes of this section, correctional facilities include Federal prisons and other institutions under the jurisdiction of the United States Department of Justice, Bureau of Prisons which are located within this Commonwealth; institutions, motivational boot camps and community corrections centers operated or contracted by the Department of Corrections; and jails, prisons, detention facilities or correctional institutions operated or contracted by local, county or regional prison authorities within this Commonwealth.

 (3) Health care facilities, as defined in section 802.1 of the Health Care Facilities Act (35 P.S. § 448.802a), including a general, chronic disease or other type of hospital; a home health care agency; a home care agency; a hospice; a long-term care nursing facility; a cancer treatment center; an ambulatory surgical facility or a birth center.

 (4) Any other facility licensed and regulated by the Department of Health or a successor agency.

 (5) A ''facility,'' as defined in section 1001 of the Human Services Code (62 P.S. § 1001), including an adult day care center; child day care center; family child care home; boarding home for children; mental health establishment; personal care home; assisted living residence; nursing home, hospital or maternity home.

 (6) Any other facility licensed and regulated by the Department of Human Services or a successor agency.

 (7) Domiciliary care facilities, as defined in section 2202-A of The Administrative Code of 1929 (71 P.S. § 581-2).

 (8) Older adult daily living centers, as defined in section 2 of the Older Adult Daily Living Centers Licensing Act (62 P.S. § 1511.2).

 (9) Continuing-care provider facilities, as defined in section 3 of the Continuing-Care Provider Registration and Disclosure Act (40 P.S. § 3203).

 (10) Federally-qualified health centers, as defined in section 1905(1)(2)(B) of the Social Security Act (42 U.S.C.A. § 1369(1)(2)(B)). For purposes of this section, the term includes Federally-qualified health center lookalikes that do not receive grant funds under section 330 of the Public Health Service Act (42 U.S.C.A. § 254b).

 (11) Public or private institutions under the jurisdiction of a Federal, State or local agency.

 (12) Free and reduced-fee nonprofit health clinics.

 (13) An office or clinic of a physician who is licensed by the State Board of Medicine under the Medical Practice Act of 1985 (63 P.S. §§ 422.1—422.53) or by the State Board of Osteopathic Medicine under the Osteopathic Medical Practice Act (63 P.S. §§ 271.1—271.18), that is located in a dental health professional shortage area, as determined by the United States Department of Health and Human Services, Health Resources & Services Administration, and published on the Pennsylvania Department of Health's web site at www.health.pa.gov. For purposes of this paragraph, an office or clinic of a physician includes a ''satellite location'' as defined in § 18.122 (relating to definitions) or ''satellite operations'' as defined in § 25.142 (relating to definitions).

 (14) A ''facility,'' as defined in 28 Pa. Code § 701.1 (relating to general definitions) that is licensed by the Department of Drug and Alcohol Programs to provide drug and alcohol treatment services.

 (d) Recordkeeping. A public health dental hygiene practitioner shall maintain a dental record which accurately, legibly and completely reflects the dental hygiene services provided to the patient. The dental record must be retained for at least 5 years from the date of the last treatment entry. The dental record must include, at a minimum, the following:

 (1) The name and address of the patient and, if the patient is a minor, the name of the patient's parents or legal guardian.

 (2) The date dental hygiene services are provided.

 (3) A description of the treatment or services rendered at each visit.

 (4) The date and type of radiographs taken, if any, and documentation demonstrating the necessity or justification for taking radiographs, as well as the radiographs themselves.

 (5) Documentation of the annual referral to a dentist.

[Pa.B. Doc. No. 21-79. Filed for public inspection January 15, 2021, 9:00 a.m.]



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