RULES AND REGULATIONS
Title 49—PROFESSIONAL AND VOCATIONAL STANDARDS
STATE BOARD OF MEDICINE
[ 49 PA. CODE CHS. 16 AND 18 ]
Prosthetists, Orthotists, Pedorthists and Orthotic Fitters
[46 Pa.B. 6618]
[Saturday, October 22, 2016]The State Board of Medicine (Board) amends §§ 16.11 and 16.13 (relating to licenses, certificates and registrations; and licensure, certification, examination and registration fees) and adds Chapter 18, Subchapter L (relating to prosthetists, orthotists, pedorthists and orthotic fitters) to read as set forth in Annex A.
Effective Date
This final-form rulemaking will be effective upon publication in the Pennsylvania Bulletin.
Statutory Authority
The act of July 5, 2012 (P.L. 873, No. 90) (Act 90) amended the Medical Practice Act of 1985 (act) (63 P.S. §§ 422.1—422.51a) to require the Board to issue licenses to prosthetists, orthotists, pedorthists and orthotic fitters, to regulate the practice of these professions and to discipline licensees. Following the delivery of proposed rulemaking on June 30, 2014, published at 44 Pa.B. 4364 (July 12, 2014), the General Assembly amended Act 90 by way of the act of July 2, 2014 (P.L. 941, No. 104) (Act 104). The Act 104 amendments altered the qualifications for licensure without examination and extended the date for individuals to obtain licensure without examination to March 31, 2015.
This final-form rulemaking is authorized under section 3 of Act 90 and under section 2 of Act 104, as well as under section 8 of the act (63 P.S. § 422.8), which authorizes the Board to adopt regulations as are reasonably necessary to carry out the purposes of the act.
Summary of Comments and Responses to Proposed Rulemaking
Notice of the proposed rulemaking was published at 44 Pa.B. 4364, with a 30-day public comment period. The Board received comments from members of the regulated community and the public, the House Professional Licensure Committee (HPLC) and the Independent Regulatory Review Commission (IRRC). Several commentators submitted comments stating that some of the provisions of the proposed rulemaking were not consistent with Act 104. Because the Board's adoption of the proposed rulemaking predated the passage of Act 104, the Board was aware that, at the time of publication, some of the provisions conflicted with Act 104. The provisions of Act 104 which related to the alternate pathway for licensure expired on March 31, 2015. Accordingly, those sections of the proposed rulemaking related to the alternate pathway have been withdrawn. As of early May 2016, the Board issued the following licenses:
Alternate Pathway Traditional Licensure Prosthetist 168 52 Orthotist 256 58 Pedorthist 79 38 Orthotic Fitter 120 70 Comments from the Pennsylvania Orthotic and Prosthetic Society
Eileen Levis, President of the Pennsylvania Orthotic and Prosthetic Society (POPS), submitted comments on behalf of POPS on July 25, 2014. Several of the POPS comments related to the Board's references to the Commission on Accreditation of Allied Health Education Programs (CAAHEP), the National Commission for Certifying Agencies (NCCA) and the National Commission on Orthotic and Prosthetic Education (NCOPE). POPS asserted that the Board should delete references in the final-form rulemaking to CAAHEP and NCOPE because these organizations are not listed in Act 90. Act 90 includes a definition for only two organizations—the Institute for Credentialing Excellence (ICE) and NCCA. Conversely, POPS asserted that the Board should reference the Board of Certification/Accreditation International, Inc. (BOC) and the American Board for Certification in Orthotics, Prosthetics and Pedorthics, Inc. (ABC) and further asserted that the Board should list the Accrediting Bureau of Health Education Schools (ABHES) in the regulations. Neither Act 90 nor Act 104 mentions BOC, ABC or ABHES, just as neither mentions CAAHEP or NCOPE.
The Board believes it is important to refer to both CAAHEP and NCOPE. Section 13.5 of the act (63 P.S. § 422.13e) requires that applicants for licensure as a prosthetist, orthotist, pedorthist or orthotic fitter have received certification by a prosthetic, orthotic, pedorthic or orthotic fitter credentialing organization accredited by NCCA. The two NCCA-accredited organizations that currently certify individuals in orthotics, prosthetics and pedorthics are ABC and BOC. To meet the qualifications for certification by ABC or BOC as a prosthetist or orthotist, an individual shall complete a CAAHEP-accredited education program and an NCOPE-approved residency program. To meet the qualifications for certification by ABC or BOC as a pedorthist, an individual shall complete an NCOPE-approved pedorthic precertification education program. The Board's reference to CAAHEP and NCOPE in the regulations alerts the public that approved education is required for licensure in orthotics and prosthetics in this Commonwealth. All 12 United States institutions that offer prosthetics/orthotics education at the bachelor's degree or higher degree level are accredited by CAAHEP. (The accredited programs are at Alabama State University, California State University, Loma Linda University, University of Hartford, St. Petersburg College, Georgia Institute of Technology, Northwestern University, Eastern Michigan University, Century College, University of Pittsburgh, University of Texas Southwest Medical Center and the University of Washington.) Moreover, 10 of the other 13 states that license orthotists and prosthetists specifically reference CAAHEP as the accrediting body for orthotic and prosthetic education. (CAAHEP does not accredit pedorthic or orthotic fitter education programs.) Accordingly, the Board believes the regulations correctly reference CAAHEP.
POPS suggested that the Board should refer to ABHES in its regulations. ABHES accredits diploma technology programs and some associate degree programs. ABHES does not currently accredit prosthetic, orthotic, pedorthic or orthotic fitter education programs. Because ABHES does not accredit programs in the professions addressed by Acts 90 and 104, the Board declines to specifically reference it in the regulations.
POPS objected to the Board's references to NCOPE in §§ 18.802, 18.811, 18.812, 18.822, 18.823, 18.831, 18.833, 18.841 and 18.843. In response, the Board notes that certification (by ABC or BOC) is a prerequisite to licensure; completion of an NCOPE-approved residency program is a prerequisite to certification. Accordingly, the regulations regarding licensure should reference NCOPE so that everyone reading the regulations has notice that an NCOPE-approved residency is required for licensure. Moreover, every other state which licenses orthotists and prosthetists explicitly requires completion of an NCOPE-approved residency program as a qualification for licensure.
Similarly, regulations regarding a graduate permit should reference NCOPE. In §§ 18.811(b)(3) and 18.821(b)(3) (relating to graduate permit), the Board requires an applicants for a graduate permit as a prosthetist or orthotist to register with NCOPE for residency. The graduate permit authorizes the holder to practice the profession only within the approved residency program, where appropriate clinical education and supervision/monitoring of the new graduate's skills may occur. POPS asserted that requiring clinical residencies to be NCOPE-approved would be inconsistent ''with the language or intent of the statute'' and ''would also restrict individuals certified prior to the creation date of 1999, from qualifying for a license.'' However, no one who was certified prior to 1999 would now be applying to the Board for a graduate permit to participate in a clinical residency program. Individuals that were certified prior to 1999 would have already qualified for licensure under the alternate pathway for existing practitioners.
If POPS is suggesting that the Board should issue graduate permits to authorize individuals to practice the profession in some way other than within an NCOPE-approved residency prior to meeting the qualifications for licensure, the Board disagrees. The Board is charged with regulating the professions in the interest of public health and safety; in its regulation of all the professions that it licenses, the Board requires individuals seeking licensure to be enrolled in or to have completed an education or experiential learning program that the Board finds to be of sufficiently high quality to ensure public health and safety. Moreover, the requirement that individuals complete an NCOPE-accredited residency is consistent with the requirements for certification by both ABC and BOC, and with the requirements for licensure in other states. Permitting graduates to practice without the educational structure and supervision of an approved residency program would endanger the public health and safety and would be a disservice to the graduates who would not be able to meet qualifications for certification or licensure through a work experience that is not an NCOPE-approved residency. Accordingly, the Board declines to delete its references to NCOPE.
Also related to residency, POPS suggested that the provisions regarding clinical residency for prosthetists and orthotists in §§ 18.812 and 18.822 (relating to clinical residency) should permit graduate permit holders to practice only under the supervision of a licensee of the Board. Upon review, the Board agrees that only individuals who plan to complete a clinical residency within this Commonwealth would need to apply for a graduate permit. That is, individuals completing a clinical residency in another state would not need to apply for or obtain a graduate permit from the Board. Therefore, the Board amended these provisions to require that the supervisor be a licensee of the Board as suggested by POPS.
Regarding §§ 18.814 and 18.824 (relating to prosthetist license; and orthotist license), POPS asserted that the Board's requirement that an applicant has earned a bachelor's degree, post-baccalaureate certificate or higher degree from a CAAHEP-accredited education program is inconsistent with the act and that the Board should only require that an applicant be certified by a certification program accredited by NCCA. The Board disagrees that certification by a certification program accredited by NCCA is the only requirement for licensure. Certification is a requirement for licensure in section 13.5(a)(3) of the act. The licensure qualification of meeting particular educational minimums is in section 13.5(a)(2) of the act. Moreover, CAAHEP is the only National accrediting body for orthotic and prosthetic education programs and is required in all states that license these professionals.
POPS suggested that the Board delete the definition of ''custom-designed device'' proposed in § 18.802 (relating to definitions) stating that this is not a term recognized by the Center for Medicare & Medicaid Services (CMS) or the industry. The term is used in section 2 of the act (63 P.S. § 422.2) in the definition of ''prosthesis.'' The definition begins with ''a custom-designed, custom-fabricated, custom-fitted or custom-modified device.'' However, the act further defines only two of the terms: ''custom-fabricated device'' and ''custom-fitted device.'' Accordingly, the Board defined the other two terms used in the act, custom-designed device and custom-modified device, basing the definitions on input from industry stakeholders.
POPS suggested that the Board's definition of ''pedorthic device'' is contrary to the act because subparagraph (ii) is not, according to POPS, in the act. The Board respectfully disagrees. The definition of ''pedorthic device'' included in § 18.802 is virtually identical to that in section 2 of the act, which specifically excludes ''nontherapeutic, accommodative inlays and nonthera-peutic accommodative footwear, regardless of method of manufacture; unmodified, nontherapeutic over-the-counter shoes; or prefabricated unmodified or unmodifiable foot care and footwear products.'' The only difference is in the formatting.
POPS commented that proposed §§ 18.816, 18.826, 18.835 and 18.845 only pertain to licensure under the alternate pathway and should be deleted or amended to conform to Act 104. These sections were intended to provide guidance to applicants with regard to how to demonstrate that they meet the various requirements for licensure, whether by the traditional pathway or by the alternate pathway. Now that the alternate pathway to licensure is no longer available, the Board withdrew these sections from this final-form rulemaking. The Board revised all other relevant sections to clarify the documentation necessary to demonstrate the qualifications required for licensure as a prosthetist, orthotist, pedorthist or orthotic fitter.
POPS suggested that the Board should not have separated the educational and experiential qualifications for prosthetist and orthotist licensure in §§ 18.814(b)(2) and (3) and 18.824(b)(2) and (3). The Board finds that the provisions are separated by ''and'' in section 13.5(a)(2)(i) and (ii) of the act, and that the list of qualifications is easier to read separated into paragraphs. Therefore, the Board declines to place the two qualifications into a single sentence as recommended by POPS.
Regarding § 18.832 (relating to patient fitting experience) for graduate pedorthists, POPS suggested that a graduate pedorthist should be permitted to obtain the patient fitting experience under the direct supervision of a prosthetist or orthotist as well as a pedorthist. The Board was not aware that prosthetists' work was sufficiently similar to pedorthists' work, but defers to POPS' knowledge in this area and made the change.
Regarding maintenance of certification, POPS commented that Act 90 does not require licensees to maintain their certification and POPS does not believe that it should be a requirement for license renewal. The proposed rulemaking also did not require licensees to maintain their ABC or BOC certifications. Nowhere in § 18.861 (relating to biennial renewal of license) is there mention of the maintenance of certification as a condition of renewal. However, the Board strongly recommends that a professional who holds a certification from ABC or BOC maintain that certification, which may be needed should the licensee seek to relocate to another state. In addition, certification provides a professional community to licensees and a source for keeping up to date on practice issues. Finally, certification may be required by employers as a condition of employment or by insurers as a condition of payment.
Finally, POPS stated that ''application for licensure appears to extend to anyone in any state. POPS believes the regulations should require the individual to be working for a company located within the Commonwealth.'' The Board declines to adopt this requirement because it believes the restriction would violate the United States and Pennsylvania Constitutions and would be a barrier to individuals who are considering relocating to this Commonwealth to practice their profession but who wish to secure licensure before finalizing a decision to relocate to this Commonwealth.
Comments related to practice by unlicensed individuals
Regarding proposed § 18.852 (relating to supervision and assistance), POPS commented that Act 90 ''clearly prohibits the delegation of patient care to non-licensed individuals.'' While the Board agrees that prosthetics, orthotics, pedorthics or orthotic fitting as defined in the act may be exclusively performed by licensed individuals, several stakeholders indicated to the Board that orthotic and prosthetic assistants and orthotic and prosthetic technicians were standard types of employees in the industry, as is the case in many other health care fields. The Board defines ''orthotic and prosthetic assistant'' in § 18.802 as an individual who assists with patient care tasks, not an individual who provides that care. In addition, in proposed § 18.852(b), the Board specifically provided that a task may not be delegated to an unlicensed assistant ''if the performance of the task is restricted by law to performance by'' a licensed individual, or if the performance of the task requires knowledge or skill not ordinarily possessed by assistive personnel. However, upon review of this comment, and with significant input from the regulated community, the Board revised and renamed § 18.852 as pertaining to ''supervision and assistance'' by unlicensed assistive personnel. As revised, orthotic and prosthetic assistants and pedorthic support personnel shall be subject to direct supervision, defined so that the prosthetist, orthotist or pedorthist is on the premises, periodically observes and is continuously available to provide guidance to the assistant.
Sofya Tamarkin, a certified pedorthist, submitted comments suggesting that the Board adopt a definition for ''indirect supervision'' as used in Iowa, which would ''imply that a licensed certified professional would be liable and responsible for any non-licensed Orthotic Fitters.'' According to this commentator, the proposal would also make the licensed professional accountable for training and formal education of nonlicensed individuals. Licensed professionals would not be present during the delivery of care. However, the licensee would be required to sign medical records produced by nonlicensed professionals. In addition, the licensee would be required to be available for direct consultation within 15 minutes during the patient's visit in case direct supervision would be required.
In response, the Board notes that in Iowa Nationally-certified orthotic fitters are not licensed and the definition of ''indirect supervision'' refers to delegation of orthotic fitting tasks to these individuals. The Iowa provision does not permit delegation to noncertified orthotic fitters. In this Commonwealth, the act does provide for licensure of Nationally-certified orthotic fitters. The Board believes that the proposed rulemaking was actually more inclusive of supportive personnel because it allowed assignment of tasks to these individuals so long as assignment of the task is consistent with the standards of acceptable practice embraced by the prosthetic, orthotic or pedorthic community in this Commonwealth. This revised final-form rulemaking also provides that only a prosthetist, orthotist or pedorthist may perform an initial patient evaluation and the final provision of a prosthetic, orthotic or pedorthic device to a patient, and that the licensee assigning and supervising the tasks shall bear ultimate responsibility for the completed tasks.
Senator Mike Stack made a similar comment on behalf of his constituents, suggesting the Board permit indirect supervision of nonlicensed orthotic fitters. He suggested the following language:
Indirect supervision—non-licensed Orthotic Fitters are qualified to provide patient care independent of a licensee; however, the licensed supervisor must review and countersign all entries in the patient's clinical record within 15 working days following the delivery of care. The supervisor must be physically available for consultation within 60 minutes during the delivery of care.Irina Rabovetski, Esq., made an identical suggestion.
Ashley Nicoletti, Esq., provided a similar comment, suggesting that a definition of ''indirect supervision'' similar to the ABC and BOC guidelines be included. The commentator suggested the following language:
Indirect Supervision does not require the supervising credentialed individual to be on-site however they must be available for consultation throughout the patient care process. The supervisor must review the results of care and the documentation of the services rendered by the supervised individual and is responsible for countersigning within 15 days all entries in the patient's clinical record.This commentator explained that this addition was suggested because the regulation:
. . .does not allow for individuals who have been working for less than 2 years to occupy the role of Orthotic Fitter without passing a required board exam. This means that individuals wanting to work in this field have to pass an extremely difficult test that requires intricate medical knowledge. This makes it difficult for existing businesses to hire new employees due to the on-site supervision requirement currently required for new employees.This commentator opined that access to care would be diminished if the Board did not adopt indirect supervision for unlicensed individuals.
The Board believes that the intent of the General Assembly was to ensure public protection by requiring licensure for orthotic and prosthetic, pedorthic and orthotic fitting caregivers. To adopt a regulation that permits unlicensed individuals to provide orthotic and prosthetic, pedorthic and orthotic fitting care to patients would be inconsistent with statute. The Board declines to add this provision.
POPS suggested that the Board delete the definition of ''orthotic and prosthetic assistant'' in § 18.802 because CMS does not recognize these ''classes'' and because the purpose of the act was to clarify that only licensed individuals are permitted to provide orthotic, prosthetic and pedorthic care. First, the Board notes that CMS rules relate to insurance reimbursement, not to the practice of the professions. The act provides that only licensed individuals may practice prosthetics, orthotics, pedorthics or orthotic fitting within the scope of practice of their license; it does not prohibit unlicensed assistants from providing assistance to licensees so long as the assistant is not practicing the licensed profession. Assistants are common in all health care fields; there are nurse aides, medication aides, medical assistants and medical technicians, for example. POPS suggested that licensees should only be permitted to be assisted by orthotic fitters, occupational therapists, physical therapists and athletic trainers. Nothing in the act suggests that occupational therapists, physical therapists or athletic trainers may take orders from orthotic and prosthetic professionals. Indeed, the practice acts which regulate the practice of occupational therapists, physical therapists and athletic trainers do not authorize these licensees to take orders from orthotists, prosthetists or pedorthists. Moreover, both assistants and technicians are recognized in all but one of the other states which license the prosthetic, orthotic and pedorthic professions.
Regarding orthotic and prosthetic technicians, the Board shares POPS' understanding that these are individual engaged in manufacturing and repairing devices and are not directly involved in patient care. The Board believes that these individuals should be recognized so that, for example, a licensed prosthetist would not be required to perform every discrete task in the manufacture of a prosthetic device, such as painting details on an artificial hand. Technicians appear to be recognized in the industry, as well as being recognized in every other state that licenses orthotic and prosthetic professionals. Accordingly, the Board declines to delete the definition of ''orthotic and prosthetic technician'' in § 18.202. However, the Board revised this final-form rulemaking to provide that a prosthetist or orthotist may assign tasks related to the fabrication, assembly, modification and servicing of prosthetic and orthotic devices to technicians working to the specifications provided by the prosthetist or orthotist. This final-form rulemaking also makes it clear that the prosthetist, orthotist or pedorthist bears the ultimate responsibility for the tasks performed by assistants and technicians.
Comments from BOC
Claudia Zacharias, President and CEO of BOC, noted that the Board's references to National certification were stated inconsistently throughout the proposed rulemaking, and suggested, as a solution, that the Board amend the definitions of ''ABC'' and ''BOC'' to provide that these organizations are National certification organizations ''approved and recognized by the Board.'' The Board agrees that the act requires applicants to ''have received certification by a prosthetic, orthotic, pedorthic and orthotic fitting credentialing organization. . .approved by the board'' and, amended the definitions of ''ABC'' and ''BOC'' to clarify that they are Board-approved organizations. In addition to amending these definitions, the Board amended the sections noted by BOC as not referring to certification consistently so that the references are internally consistent.
BOC commented that § 18.832(a) authorizes a graduate pedorthist with a temporary practice permit to practice only under the direct supervision of a pedorthist, and suggested that a graduate pedorthist should be permitted to practice under the direct supervision of a licensed orthotist or prosthetist as well. The Board amended § 18.832(a) accordingly.
BOC noted that proposed § 18.835(4), regarding demonstration of qualifications, which referred to the experiential component of pedorthic education should state ''direct patient care in pedorthics'' rather than ''patient fitting experience.'' In response, the Board notes that section 13.5(a)(2)(iii) of act requires pedorthists to complete ''a minimum of 1,000 hours of supervised patient fitting experience.'' The Board prefers to retain the statutory term. In this final-form rulemaking, the text of proposed § 18.835(4) has been moved to § 18.833(b)(3) (relating to pedorthist license). In response to BOC's comment, the Board added qualifying language to clarify that the patient fitting experience consists of providing direct patient care in pedorthics.
Comments from R.J. Hedges & Associates
R.J. Hedges & Associates (RJH) stated that its comments were coordinated with the pharmacy, durable medical equipment and mastectomy organizations in this Commonwealth. RJH suggested that the Board add a definition of ''facility'' to clarify that the licensed individual is a legally operating business within this Commonwealth. The definition would provide that ''facility'' means the business location where care is provided and has appropriate equipment to provide comprehensive orthotic, prosthetic and pedorthic care; and that licensees shall be available to provide the care or supervise the provision of care by orthotic fitters or nonlicensed staff. The Board notes first that the act does not require orthotic fitters to practice under the supervision of orthotists, prosthetists or pedorthists. In addition, definitions are added for terms used in the regulations; ''facility'' is not used in the regulations and the Board does not see a need to define the term. Finally, it is the Board's understanding that practice may take place in a variety of settings, including a hospital, rehabilitation center or private office. The Board is not aware that all care shall take place in a facility that has the equipment to provide comprehensive care; some follow-up care, for example, may take place in an office that is separate from the comprehensive care facility.
RJH suggested that the Board include a definition of ''level of competence'' which would be defined as ''a hierarchical position that an individual occupies within a field or profession relative to other practitioners in the profession.'' Because neither the act nor the regulations use ''level of competence,'' there is no need to define the term.
Like the BOC comment, RJH commented regarding the different terms used by the Board when discussing the type of certification required. The Board made amendments as previously discussed to standardize the terminology used in this final-form rulemaking. Similarly, RJH noted that a pedorthist trainee should be able to practice under the supervision of a prosthetist or orthotist as well as a pedorthist. The Board amended § 18.832(a) accordingly. Finally, RJH commented that the term for the experience obtained by a pedorthist should properly be called ''direct patient care'' rather than ''patient fitting.'' As previously noted, the Board addressed this comment by qualifying the statutory term ''supervised patient fitting experience'' as providing direct patient care in pedorthics.
Comments from C-Fab 1, Inc.
C-Fab 1, Inc. submitted comments on May 25, 2015. The comments were written by a self-identified ''prosthetic and orthotic technician'' practicing for 35 years who owns a fabrication lab and provides devices to orthotists, prosthetists and pedorthists in this Commonwealth. The comment pointed out that technicians are not support personnel; rather, technicians fabricate and assemble devices based on a work order and specific instructions and measurements from a licensed professional. Once manufactured, the device is returned to the licensee for final fitting. The commentator also noted that individuals in fabrication businesses are not supervised by licensees. The commentator suggested that the definition of ''orthotic and prosthetic technician'' in § 18.202 should state that technicians manufacture, fabricate, modify, adjust, repair or maintain devices using a mold or specifications provided to them by a licensed orthotist, prosthetist or pedorthist. The Board adopted a substantially similar definition, eliminating ''adjust'' as it believes an adjustment would be made in the patient care process. The definition has also been amended to eliminate the requirement of direct supervision. The Board also amended § 18.852 to clarify that the prosthetist or orthotist shall provide all of the necessary measurements and instructions to the technician for the fabrication, assembly, modification and servicing of the device.
Comments from the HPLC
The HPLC submitted comments on August 28, 2014, asking the Board to explain its statutory authority pertaining to graduate permits, clinical residency and provisional licensure for prosthetists and orthotists. The Board has broad authority to promulgate regulations to effectuate the act. The act aims to promote the health and welfare of the citizens of this Commonwealth by ensuring they have access to properly trained orthotic and prosthetic professionals. The training of prosthetists and orthotists needed for licensure includes both didactic education and clinical education/experience. That is, to obtain certification by ABC or BOC a prosthetist or orthotist is required to complete a 1-year clinical residency, and the act provides the requirement of a minimum of 2 years (3,800 hours) of experience in providing direct patient care services. At the same time, the act prohibits the practice of these professions without licensure. Therefore, neither of these licensee classes could obtain the required clinical education or experience without actually practicing the profession as defined in the act. Accordingly, the Board had to develop some system which would allow these professionals to complete their clinical education and experience requirements without otherwise violating the act.
Without the graduate permits and provisional licenses devised by the Board, graduates of a prosthetist and orthotist education program would be required to complete the clinical residency and supervised experience required for full licensure in another state. Similarly, graduates of a pedorthist and orthotic fitter education program would be required to leave this Commonwealth to complete the 1,000 hours of experience required for full licensure, which is why the Board created a temporary practice permit for those license classes. The Board believes that it cannot effectuate the statutory intent of ensuring access to quality orthotic and prosthetic professional services without allowing completion of the clinical portion of professional education (clinical residency) and the experience required by the act to take place within this Commonwealth. The Board believes that the creation of these permits and provisional licenses was necessary to effectuate the intent of the act.
The HPLC commented that the Board should be more specific pertaining to §§ 18.814(b)(6) and 18.824(b)(6), suggesting that the Board make reference to the act for licensees who need more clarification. Sections 18.814(b)(6) and 18.824(b)(6) provided that an applicant for licensure shall ''otherwise satisf[y] the requirements for licensure'' and not be barred from licensure. The Board determined that the provision is superfluous and deleted it from this final-form rulemaking.
Finally, the HPLC commented that it understood the Board would be making amendments to the proposed rulemaking to conform to Act 104, and that it looked forward to seeing the advance notice of final rulemaking (ANFR). Because the provisions of Act 104 expired as of March 31, 2015, the Board deleted the sections regarding alternative pathways to licensure.
Comments from IRRC
IRRC submitted comments on September 10, 2014. IRRC noted that ''[a] commentator, the Pennsylvania Orthotic Prosthetic Society, states that it was not included as a stakeholder, and therefore, there was not an equitable exchange among stakeholders.'' Upon passage of Act 90, the Board was contacted by only one stakeholder, ABC, offering assistance with drafting of the rulemaking. The Board attempted to identify stakeholders by: finding the prosthetist, orthotist and pedorthist educational programs in this Commonwealth; researching certification and identifying the relevant certification bodies; identifying the State professional association; and speaking with legislative staff regarding who might be an interested party.
For the first public meeting with stakeholders, the Board invited 33 individuals, including: Claudia Zacharias, President, BOC; Stephen Fletcher, Director of Clinical Resources, and Catherine Carter, Executive Director, ABC; the Pennsylvania Orthopedic Society, the Amputee Coalition of America, the Pennsylvania Occupational Therapy Association, the Pennsylvania Orthopedic Society, the Pennsylvania Physical Therapy Association and the Pennsylvania Medical Society; Randy Stevens and Eileen Levis, POPS; representatives from the University of Pittsburgh's graduate program in orthotics and prosthetics; representatives from the Temple University School of Podiatry, which had run a pedorthics educational program; Brian Lagana, Executive Director, Pedorthic Footcare Association; industry representatives from Carter Orthopedics and the National Orthotics Manufacturers Association; Anjali Weber, Director of Accreditation, ICE; and Marlene Tremmel and Sharon Engdahl, HPLC staff.
The first public meeting with stakeholders held in September 2012 was attended by 17 individuals, including 4 who identified themselves to the Board as being from POPS—Randy Stevens, Kristen Ortiz, Eileen Levis and Joe Carter. In attendance also were representatives from BOC, ABC, the National Orthotics Manufacturers Association, the Pennsylvania Orthopaedic Society, the Pennsylvania Medical Society, the University of Pittsburgh, the Occupational Therapy Association, ICE and several other individuals representing licensees of the Board. The representatives from POPS also attended the Board's second public meeting with stakeholders in November 2012.
In addition, the Board requested that the stakeholders that it had identified communicate with their colleagues and inform them of the November 2012 public meeting should anyone else wish to attend. During the drafting of the proposed rulemaking, the Board also received and considered comments from individuals who wrote to the Board, including: Caryn Plessinger, President, Hub's Home Oxygen & Medical Supplies/CressCare Medical; Michael J. Gartland, Compliance Analyst, Klingensmith Health Care; Dana Finn, Facility Accreditation Coordinator, BOC; Zack Chait, BOC; Anjali Weber, ICE; Steve Fletcher, ABC; Claudia Zacharias, BOC; Eileen Levis, POPS; Randy Stevens, POPS; and Sofya Tamarkin. In addition to multiple meetings with stakeholders, the Board's Allied Health Committee met with Sofya Tamarkin to discuss her concerns. Finally, the Board met with stakeholders and legislative staff to discuss the Act 104 amendments.
IRRC asked the Board to work with the regulated community to resolve as many concerns as possible prior to submitting this final-form rulemaking. The Board worked with the regulated community since passage of Acts 90 and 104 and has continued to do so. The Board is not aware of any particular concern from the regulated community that was not addressed by the amendatory act or that has not been addressed by the amendments to this final-form rulemaking. The Board believes this final-form rulemaking has brought consensus among the stakeholders to the greatest extent possible.
IRRC acknowledged the HPLC comments regarding the Board's statutory authority for graduate permits, clinical residency and provisional licenses for prosthetist and orthotist and the need for clarification of certain sections. IRRC stated that it would review the Board's response as part of its determination of whether this final-form rulemaking is in the public interest.
IRRC noted that the Board provided fee reports for all of the fees regarding specific license applications but did not provide a breakdown of ''Fee-related Activities and Costs'' in the fee report form for the biennial renewal fee. Fee report forms for application fees set forth very specific activities regarding discrete functions performed by Board staff regarding the processing of each application. These ''Fee-related Activities and Costs'' are applicable only to the fees associated with processing applications of various types. The cost of processing applications, which is offset by the application fee, is based on the amount of time a staff member will need to perform the tasks regarding processing and issuing a particular license type, and the salary level of the classification of the staff member that will be required to perform the tasks. Some tasks are performed by lower or higher employee classifications, depending on the complexity of the task. Fees for discrete services provided to an individual, such as processing an application, are set by having the Bureau's revenue office prepare a fee report form after meeting with the Board's administrative staff to determine the tasks related to providing that service. See section 6(d) of the act (63 P.S. § 422.6(d)), which provides that the ''board may charge a reasonable fee. . .for all examinations, registrations, certificates, licensures or applications permitted by this act or the regulations thereunder.''
Biennial renewal fees, on the other hand, are not based on specific tasks or services performed for individual licensees/applicants. Biennial renewal fees are required to be set to meet the overall operating expenses of the Board, as set forth in section 6(a) of the act. Revenues raised by fees, fines and civil penalties must be sufficient to meet expenditures over a 2-year period. The Board must increase fees by regulation so that projected revenues will meet or exceed projected expenditures. In other words, the biennial renewal fees are designed to cover all the operating expenses of the Board that are not covered by any other fee, including building-related costs, personnel costs, hearing officer costs, investigations based on public complaints, attorney costs and administrative officer costs. The biennial renewal fee is not based on an estimate of particular tasks performed by each type of employee and the classification of the employee, so the fee report form for biennial renewal fees does not include this type of calculation. The types of work for which the revenue generated from biennial fees is allocated includes the intake and processing of complaints filed with the Bureau relevant to the licensees of the Board, the investigation of complaints by the Bureau of Enforcement and Investigation, review of complaints by legal assistants/paralegals, payment for experts to review information and to provide written reports and testimony, costs of prosecution, costs to hold hearings and pay for transcripts and witness fees, cost for legal support to the Board, cost for regulatory support for the Board, cost for administrative support/staff of the Board, and overhead costs including building and power, books, subscriptions, memberships, and the like. Biennial renewal fees are not calculated in the way that application fees are and a fee report form cannot capture information relevant to reviewing a biennial fee. In determining biennial renewal fees, the Board reviews its financial reports and recommendations prepared by the Bureau of Finance and Operations.
The most recent fiscal report of the Board was delivered by the Bureau of Finance and Operations at the Board's April 19, 2016, meeting. The following is the Fiscal Year 2015-2016 budget for the Board:
Administrative costs Board administration $2,445,000 Commissioner's Office $51,000 Revenue Office $40,000 Departmental services $362,000 Board member expenses $48,000 Legal costs Legal Office $2,471,000 Hearing expenses $16,000 Professional Compliance Office $536,000 Enforcement and investigation $1,617,000 Professional Health Monitoring Programs $298,000 Total Board Costs $8,184,000 Regarding § 18.802, IRRC asked the Board to explain how designating CAAHEP and NCOPE as ''additional accreditation and certification programs is necessary and reasonable as relates to qualification for licensure.'' As more fully discussed in response to comments from POPS, referencing CAAHEP and NCOPE does not impose additional qualification for licensure. The act requires certification by an organization that is recognized by ICE and accredited by NCCA. Both ICE-recognized, NCCA-accredited organizations that offer certification as a prosthetist or orthotist require completion of a CAAHEP-approved educational program and an NCOPE-approved residency program. IRRC also questioned the need for a definition of ''custom-designed device.'' The Board also discussed its rationale for including a definition of ''custom-designed device'' in its response to comments from POPS. The Board believes that providing a definition of the term, which is used in the definition of ''prosthesis,'' will aid clarity, as opposed to creating ambiguity.
IRRC pointed out that the Board used several phrases, including ''licensed by the Board'' and ''licensed under the act,'' to describe licensees in § 18.802. The Board amended these definitions to make them consistent. IRRC commented on the Board's definition of ''prefabricated orthotic devices'' and asked why the Board deviated from the term provided for in Act 90, which was ''prefabricated orthosis.'' The deviation was unintentional and the Board amended § 18.802 accordingly.
IRRC asked the Board to consider including provisions regarding the titles that the holders of graduate permits, provisional licenses and temporary permits may use. The Board added provisions regarding the titles that may be used in §§ 18.811(e), 18.813(e), 18.821(e), 18.823(e), 18.831(e) and 18.841(e) as well as defining the titles in § 18.802. In addition, the Board added provisions requiring permit holders and provisional licensees to inform patients of the status of their licensure. The Board determined that the appropriate title for a prosthetist or orthotist during the period of the residency is ''prosthetist/orthotist resident.'' The Board determined that the appropriate title for a prosthetist or orthotist during the period after the residency is completed but before all examinations have been completed and full licensure granted is ''provisionally-licensed prosthetist/orthotist.'' The Board proposed to call pedorthists and orthotic fitters in training ''graduate pedorthist/orthotic fitter.'' The Board determined that these providers are more commonly known as trainees or ''in training.'' The Board settled upon ''pedorthist/orthotic fitter trainee'' because it is shorter and easier for employers to fit on an identification badge.
IRRC noted a misplaced provision in § 18.814(b)(3) pertaining to the method to demonstrate completion of 3,800 hours of experience in providing direct patient care. IRRC questioned whether this provision was necessary in that proposed § 18.816, regarding demonstration of qualifications, contained the necessary information concerning how to demonstrate the experience requirements. Instead of removing the provision from § 18.814, the Board revised this final-rulemaking to delete the separate sections pertaining to demonstration of qualifications (including § 18.816) and instead amended the final-form rulemaking to include in each relevant section information relating to how an applicant may demonstrate meeting each qualification. In this way, an applicant has only one section to review to obtain the information necessary to apply for a specific credential.
IRRC commented that proposed § 18.815, regarding alternate pathway for prosthetist license, expired on July 7, 2014, and asked the Board to withdraw this section. Act 104 replaced provisions in Act 90 regarding licensure without examination and provided a new expiration date of March 31, 2015. As that date has also passed, the Board withdrew § 18.815 and §§ 18.825, 18.834 and 18.844, the coordinate sections for the other profession.
Regarding proposed §§ 18.816, 18.826, 18.835 and 18.845, IRRC asked the Board to make amendments to ensure that the requirements are clear for each type of permit or license. The Board withdrew these sections and instead revised each of the relevant licensure sections to clarify the documentation necessary to demonstrate the qualifications corresponding to each type of credential. In addition, the Board has stricken those provisions which have now expired as a result of the elimination of the alternate pathways to licensure.
Regarding § 18.823 (relating to provisional orthotist license), IRRC questioned whether the ''supervision'' referenced should be called ''direct supervision'' as it is in § 18.813(a) (relating to provisional prosthetist license). The omission in § 18.823 was inadvertent and the Board added ''direct'' to § 18.823(a).
Regarding proposed §§ 18.831 and 18.841 (relating to temporary practice permit), which provide that a temporary practice permit will expire immediately if the permit holder fails the examination, IRRC questioned what examination was being referenced and how the provision would be enforced. Upon review, the Board notes that it did not provide a restriction regarding the provisional prosthetist license or provisional orthotist license, and also determined that the certification exam providers (ABC and BOC) are under no obligation to report failures to the Board. Therefore, the proposed final sentence of these sections has been deleted. IRRC also inquired as to whether an individual could apply for another temporary practice permit, and whether the provision was necessary given that the permit is valid for only 1 year and nonrenewable. Finally, IRRC asked the Board to clarify the intent of subsection (d) and explain why it is necessary. Regarding whether subsection (d) is necessary, the remaining provision (a temporary practice permit is valid for a maximum of 1 year and is nonrenewable) is necessary because without the subsection the graduate of a pedorthic or orthotic fitter education program could practice forever without ever taking the certification examination. The act contemplates that licensure is required to provide services to the public; accordingly, the Board cannot create a permit that would allow individuals to indefinitely circumvent the licensure requirement. The Board's intent is that an individual may obtain one temporary practice permit which is valid for a maximum period of 1 year.
Regarding §§ 18.842 and 18.843 (relating to orthotic fitting care experience; and orthotic fitter license), IRRC asked the Board to explain why it required that the orthotic fitting care experience of an applicant for licensure have been completed ''under direct supervision'' whereas Act 90 required that the orthotic fitting care experience of an applicant be ''documented.'' IRRC asked the Board to explain how its regulatory provisions conform to the intent of the General Assembly and why it is reasonable and necessary for the experience to have been supervised. First, § 18.842 pertains to an individual with a temporary practice permit who is authorized to practice only under direct supervision as an exception to the general requirement that a person be fully licensed to provide patient care as an orthotic fitter. The Board determined that to protect the public health and safety, direct supervision should be required. However, as § 18.843 pertains to the qualifications necessary for full licensure, the Board acknowledges that some applicants may apply to the Board with experience gained in other states, many of which do not require licensure. Others may apply based on education and experience that was obtained prior to the passage of Act 90. Therefore, the Board deleted ''supervised'' from § 18.843(b)(3). The Board clarified that the requirement that the orthotic fitting experience be ''documented'' requires more than the applicant's assertion that the applicant completed 1,000 hours of fitting experience. Verification of the 1,000- hour requirement by an applicant's employer, supervisor or referral source is consistent with the verification source for the other licensees under Act 90.
Regarding § 18.851 (relating to scope and standards of practice), IRRC questioned the clarity and reasonableness of the requirement that a licensee may not accept a prescription or referral for care when the licensee ''knows, or has good cause to believe, that the device cannot be furnished within a reasonable period of time.'' IRRC asked what would be a reasonable period of time and opined that the Board's language does not set a binding norm. IRRC suggested that the Board revise the subsection to set clear compliance standards.
Health care professions refer to accepted standards of care or practice because it is impossible to precisely define a set numerical standard for all circumstances and situations due to the variability of a patient's condition. Thus, no time certain can be provided. Despite the inability of the Board to set a time certain that would apply for all patients in all circumstances and situations, the Board believes its regulation sets a binding norm just as does the statutory language that provides that a practitioner can be disciplined for providing a service at a level beneath the standard of care for a practitioner which would be normally exercised by the average professional in this Commonwealth. See section 41(8)(ii) of the act (63 P.S. § 422.41(8)(ii)). The Board amended § 18.851 by adding language similar to that in section 41(8) of the act, specifically, by adding ''as would be consistent with the standard of care of the average professional providing the service in this Commonwealth.''
Regarding § 18.852, IRRC correctly noted that the regulated community is divided on this section. IRRC asked the Board to explain how § 18.852 implements Act 90, particularly as it relates to section 13.5(j) of the act (which provides, in pertinent part, that any person who is not licensed as a prosthetist, orthotist, pedorthist or orthotic fitter may not practice prosthetics, orthotics, pedorthics or orthotic fitting) and how this section conforms to the intent of the General Assembly. One segment of the regulated community asserted that Act 90 does not provide for assistants, technicians or support personnel. The opposing segment of the regulated community asserted not only that Act 90 allows licensees to delegate simple tasks within their scope of practice, including basic orthotic fittings, diabetic shoes and diabetic inserts. These commentators further asserted that the licensees should be allowed to provide only indirect supervision to unlicensed persons performing these tasks.
The Board believes that neither side in the debate is entirely correct. In health care, there are both licensed and unlicensed individuals providing a range of services to patients. Examples of unlicensed individuals include certified nursing aides, medication aides, medical assistants and laboratory technicians. The Board agrees that the act prohibits the unlicensed practice of prosthetics, orthotics, pedorthics or orthotic fitting. However, members of the regulated community informed the Board that there are two types of unlicensed assistive personnel that have routinely been used in the orthotic and prosthetic profession. For this reason, the Board named and defined these types of unlicensed individuals.
The first type is the orthotic and prosthetic assistant, which is an unlicensed individual who, under direct supervision, assists an orthotist or prosthetist with patient care tasks. These assistants may not engage in unsupervised patient care; rather, they assist the orthotist or prosthetist by performing tasks assigned by the orthotist or prosthetist. An example of a task that might be performed by an orthotic assistant would be performing a follow-up check to see if there is any dermal disturbance at the site of an orthosis. The second type is the orthotic and prosthetic technician, an unlicensed individual who provides technical support to an orthotist or prosthetist and who may fabricate, assemble, modify and service devices to the specifications of the orthotist or prosthetist. These individuals do not provide patient care; rather, they provide technical support. An example of a task that might be performed by a prosthetic technician would be painting an artificial hand to match the patient's skin or pouring plastic into a mold provided by the orthotist or prosthetist. Because both of these types of unlicensed assistive personnel are commonplace in the orthotic and prosthetic profession (ABC provides certification programs for ''O&P assistants'' and ''O&P technicians'') and are recognized in nearly every other state that licenses orthotists and prosthetists, and because their duties are not so expansive as to constitute the practice of orthotics and prosthetics, the Board determined that the regulation should address these individuals.
In its regulation, the Board also recognizes pedorthic support personnel, who are unlicensed individuals who, under the direct supervision of a pedorthist, assist a pedorthist in the provision of pedorthic care. The Board includes these individuals at the request of members of the regulated community who indicated that they utilized support personnel in their pedorthic practices, but who understood that these individuals could not perform the tasks of any licensee, including an orthotic fitter. Just as orthotic and prosthetic assistants and technicians cannot practice prosthetics or orthotics, pedorthic support personnel may not practice prosthetics, orthotics, pedorthics or orthotic fitting. Pedorthics is defined in the act to include measuring patients for a pedorthic device and also to include fitting and adjusting a pedorthic device. Because the use of a ''crush box'' is for the purpose of measuring patients for a pedorthic device, only a pedorthist may perform this task. Pedorthic support personnel could be involved in teaching patients how to maintain pedorthic devices, cleaning pedorthic devices for patients, and the like.
As to the commentators who suggested that unlicensed individuals should be permitted to do orthotic fittings including diabetic shoes and inserts, the amendment in Act 104 conclusively established that fitting all therapeutic shoes requires, at a minimum, licensure as an orthotic fitter. The amendment added ''therapeutic shoes'' to the list of devices within the scope of practice of an orthotic fitter. Because even simple diabetic shoes and inserts are therapeutic and are pedorthic devices that are fitted or adjusted for the individual patient, pedorthic support personnel would be prohibited from fitting or adjusting diabetic shoes. Accordingly, unlicensed individuals may not fit diabetic shoes and inserts, no matter how simple they appear. Because pedorthic support personnel cannot perform orthotic fittings, including diabetic shoes and inserts, the Board believes that the second group of commentators may no longer have an interest in the level of supervision that shall be provided to these individuals. The Board believes that direct supervision is the most appropriate level of supervision for assistants and pedorthic support personnel.
IRRC asked if the Board considered the economic or fiscal impacts on those in the regulated community who would not desire or qualify for licensure. If IRRC is asking whether individuals who might have been interested in practicing one of the newly-regulated professions would be deterred by the costs of licensure, the Board finds the inquiry too speculative as the Board would have no way to determine how many individuals in this Commonwealth might have thought of entering one of these professions, but changed their minds because of the costs associated with licensure. The Board believes that the General Assembly would have considered this generalized cost of licensure before determining that it was in the public interest to require licensure.
IRRC also asked if the Board had considered the economic or fiscal impacts on entities which would be required to have a licensed prosthetist, orthotist or pedorthist present to provide direct supervision, and asked the Board to address these costs in the Regulatory Analysis Form. Because only a licensee may actually practice these professions, and because the work done by an orthotic and prosthetic assistant, orthotic and prosthetic technician, and pedorthic support personnel is solely in a supporting role to a licensee, there would be no additional cost to supervising support personnel. On the contrary, to the extent that support personnel free up the time of licensees to provide direct patient care, there would be an economic benefit to support personnel, not a deficit.
IRRC questioned whether references to ''the practitioner'' in § 18.852(a)(6) were references to the same individual called ''the practitioner delegating the task.'' That was the Board's intent. However, this section has been completely rewritten to address supervision and assistance by the various types of unlicensed assistive personnel, rather than delegation to clarify the Board's understanding of the role of assistants, technicians and support personnel.
IRRC asked the Board to clarify the relationship between the misconduct provisions in § 18.853 (relating to unprofessional and immoral conduct) and those in § 16.61 (relating to unprofessional and immoral conduct). The Board addressed this by amendments made to § 18.853(b)(1) and (c). Section 16.61 is a general section applying to all Board-regulated practitioners and is cross-referenced in this final-form rulemaking. Section 18.853 is intended to apply specifically to prosthetists, orthotists, pedorthists and orthotic fitters. IRRC was also concerned that § 18.853(b)(13) was confusing as written. The Board has rewritten the paragraph to aid clarity.
IRRC asked the Board to add a reference in § 18.861 to section 13.5(g)(2) of the act, which provides for continuing education requirements for pedorthists and orthotic fitters. The Board added the reference. IRRC asked the Board to review the regulation for consistency in how it addressed licensees' certification. The Board did so and more fully discusses this in its response to BOC's comments. IRRC questioned whether it was necessary to reference the disciplinary section of the act in each section of the regulations explaining each license or permit type. While technically not necessary, the Board wanted to clearly provide notice to applicants of the grounds for denial of a license. Therefore, the Board determined that it should maintain the reference in each section. IRRC noted some inconsistent wording among parallel sections. The Board revised this final-form rulemaking for consistency.
Comments following the ANFR
The Board sent a draft of the final rulemaking to stakeholders and published an ANFR at 45 Pa.B. 5682 (September 19, 2015). The Board received additional comments during the 30-day public comment period and months afterward, as late as February 2016. In late February 2016, a Board representative met with POPS' counsel to address POPS' concerns and to ensure that this final-form rulemaking protected the public and was consistent with current practices in the professions. POPS continued to object to the use of ''assistant'' and preferred ''support personnel.'' However, as ''assistant'' is used in 12 of the 13 states which license prosthetists and orthotists, the Board retains the term.
The Board also received identical comments from RJH and the Pennsylvania Pharmacists Association requesting that the Board include definitions of ''health care practitioner'' and ''pharmacist'' and add a regulation to repeat the exceptions provision in section 15.5 of the act (63 P.S. § 422.15e). According to these groups, CMS ''may take this regulation at face value and restrict pharmacists. . . from dispensing diabetic shoes and certain orthotic products.'' The Board declines to include the statutory exceptions in the regulations. First, the Board believes it is highly unlikely that CMS or any other Federal agency would ignore the plain provisions of the act. Second, regulations add clarification to procedures and policies regarding professions; regulations are not a substitute to the act and it would be improper for CMS to determine that issues not addressed in regulations are unregulated in light of clear statutory language. Finally, the Board regulates approximately a dozen health-related professions, has not included any statutory exceptions in the regulations of those professions and finds no compelling reason to deviate in this instance.
The Board received comments from Tom Sedlak, Executive Director, Pennsylvania Association of Medical Suppliers, asking if a prefabricated orthotic device includes ''step in/impression box'' or whether it means ''pre-fabricated heat molded'' devices. Act 104 amended the orthotic fitter scope of practice to specifically provide that orthotic fitting includes measuring, fitting, dispensing and adjusting prefabricated devices including therapeutic shoes. The act defines custom-fabricated and custom-fitted devices, and limits to only prosthetists, orthotists and pedorthists the provision of these devices. Custom-fabricated, by statutory definition, includes devices ''fabricated to comprehensive measurements or a mold.''
BOC submitted additional comments on February 1, 2016, noting that §§ 18.814 and 18.824 needed minor adjustment to be parallel; the Board made the adjustment. BOC also noted that the Board had not copied all provisions of the act regarding exceptions. As previously discussed, statutory exception provisions do not appear in any of the Board's regulations of health-related professionals and the Board declines to include them in these regulations. The statutory provisions are fully enforceable.
Description of amendments to this final-form rulemaking
The Board amended §§ 16.11 and 16.13 to delete the alternate pathway for licensure which has expired and to make the sections internally consistent.
In § 18.802, the Board amended the definitions of ''ABC'' and ''BOC'' to clarify that these organizations are approved by the Board. The Board combined the proposed definitions of ''custom-designed device'' and ''custom-fabricated device'' in recognition of the similarity between the two. In the definition of ''ICE,'' the Board clarified that the term includes a successor organization.
As IRRC requested the Board regulate the titles that may be used by individuals with a graduate permit, provisional license or temporary permit, the Board has added definitions for ''orthotic fitter trainee,'' ''orthotist resident,'' ''pedorthist trainee,'' ''prosthetist resident,'' ''provisionally-licensed orthotist'' and ''provisionally-licensed prosthetist.'' The Board also moved the qualifying language ''pursuant to a written prescription of a licensed prescribing practitioner'' from the definitions of ''orthotist,'' ''pedorthist'' and ''prosthetist'' to the definitions of ''orthotics,'' ''pedorthics'' and ''prosthetics'' as the phrase more properly defines the practice and not the individual licensee.
Additionally, the Board revised to the definitions of ''orthotic and prosthetic assistant,'' ''orthotic and prosthetic technician'' and ''pedorthic support personnel'' in response to public comments as previously discussed.
Amendments regarding qualifications for licensure as a prosthetist
The Board amended § 18.811 to incorporate the title ''prosthetist resident'' and to include clarifying language regarding how an applicant can demonstrate each qualification to obtain a graduate permit. The Board also added an example of other applicable law that could result in the denial of an application and has eliminated superfluous language. The Board amended § 18.812 to clarify that a prosthetist resident completing a clinical residency in this Commonwealth shall practice under the direct supervision of a licensed prosthetist.
The Board amended §§ 18.813 and 18.814 to incorporate the relevant titles and to include clarifying language regarding how an applicant can demonstrate each qualification to obtain a license. These sections are also amended to add an example of other applicable law that could result in the denial of an application and to eliminate superfluous language. Section 18.814(b)(4) was also amended to add ''another prosthetic credentialing organization whose certification program is recognized by ICE, accredited by NCCA and approved by the Board'' to the list of possible certifications. This amendment was made because the Board is aware that BOC announced its intent to discontinue issuing new certifications for prosthetists after July 2016 and another credentialing organization may choose to fill the void created by BOC's departure from the field. Although no new certifications will be issued, BOC will continue to renew existing certifications for prosthetists.
Proposed § 18.815 was withdrawn as this pathway to licensure has expired. Additionally, § 18.816 was withdrawn and its provisions moved to more clearly define the documentation needed to demonstrate the qualifications for a graduate permit, a provisional prosthetist license or a prosthetist license.
Amendments regarding qualifications for licensure as an orthotist
The Board amended § 18.821 to incorporate the title ''orthotist resident'' and to include clarifying language regarding how an applicant can demonstrate each qualification to obtain a graduate permit. The Board also added an example of other applicable law that could result in the denial of an application and has eliminated superfluous language. The Board amended § 18.822 to clarify that an orthotist resident completing a clinical residency in this Commonwealth shall practice under the direct supervision of a licensed orthotist.
The Board amended §§ 18.823 and 18.824 to incorporate the relevant titles and to include clarifying language relating to how an applicant can demonstrate each qualification to obtain a license. These sections were also amended to add an example of other applicable law that could result in the denial of an application and to eliminate superfluous language. Section 18.824(b)(4) was amended to allow for certification by another orthotic credentialing organization approved by the Board. This amendment was made because BOC announced its intent to discontinue issuing new certifications for orthotists after July 2016 and another credentialing organization may choose to fill the void created by BOC's departure from the field. Although no new certifications will be issued, BOC will continue to renew existing certifications for orthotists.
Proposed § 18.825 was withdrawn as this pathway to licensure has expired. Additionally, § 18.826 was withdrawn and its provisions moved to more clearly define the documentation needed to demonstrate the qualifications for a graduate permit, a provisional orthotist license or an orthotist license.
Amendments regarding qualifications for licensure as a pedorthist
The Board amended § 18.831 to make stylistic edits, to incorporate the title ''pedorthist trainee'' and to include clarifying language regarding how an applicant can demonstrate each qualification to obtain a temporary practice permit. The Board also amended this section to clarify that an NCOPE-approved pedorthic education program is required. The Board deleted the concept of ''equivalence'' because any equivalent training would not qualify an applicant for certification, which is a separate requirement for licensure. The Board believes it would be a disservice to applicants to accept other ''equivalent'' training for purposes of granting a temporary practice permit, knowing that the applicant would have to complete an NCOPE-approved education program to achieve certification and qualify for a license. The Board also added an example of other applicable law that could result in the denial of an application and has eliminated superfluous language.
Section 18.832 has been amended to incorporate the title ''pedorthist trainee'' and to provide for direct supervision by a licensed prosthetist, orthotist or pedorthist in response to public comments. Section 18.833 has been amended consistent with § 18.831 to eliminate the concept of ''equivalent'' education in recognition of the fact that completion of an NCOPE-approved pedorthic precertification education program is required to obtain certification, and certification is required to obtain licensure. It has also been amended to include clarifying language about how an applicant can demonstrate each qualification for licensure. Section 18.833(b)(4) has also been amended to include ''another pedorthic credentialing organization whose program is recognized by ICE, accredited by NCCA and approved by the Board.'' BOC announced its intention to discontinue issuing new certifications for pedorthists after July 2016 and the Board wants to provide for the possibility of another organization entering the field. In addition, § 18.833 has been amended to add an example of other applicable law that could result in the denial of a license and to eliminate superfluous language. Proposed §§ 18.834 and 18.835 were withdrawn.
Amendments regarding qualifications for licensure as an orthotic fitter
Sections 18.841—18.843 have been amended to incorporate the title ''orthotic fitter trainee'' and to add clarifying language about how an applicant can demonstrate each qualification. Sections 18.841(b)(2) and 18.843(b)(2) have been amended to clarify that to qualify for a temporary permit or orthotic fitter license, an applicant shall have completed an ABC-approved or BOC-approved orthotic fitter precertification education program. NCOPE announced in 2015 that it would no longer approve orthotic fitter education programs. The Board is eliminating the ''equivalent'' education option because anything other than an ABC-approved or BOC-approved program would not lead to certification. While BOC announced its intent to discontinue issuing certifications for prosthetists, orthotists and pedorthists, it will continue to issue certifications to orthotic fitters. However, the Board amended § 18.843(b)(4) to allow certification from another orthotic fitter credentialing organization whose program is recognized by ICE, accredited by NCCA and approved by the Board to be internally consistent with the prior sections. Proposed §§ 18.844 and 18.845 were withdrawn as are no longer necessary.
Amendments regarding the regulation of practice
The Board amended § 18.851 to clarify that the standard for the provision of prosthetic, orthotic or pedorthic devices would be ''within a reasonable period of time as would be consistent with the standard of care of the average professional providing the service in this Commonwealth'' in response to IRRC's comment about establishing a binding norm. With regard to § 18.852, the Board renamed this section ''supervision and assistance'' and significantly revised it in response to stakeholder comments. It now provides standards for assigning tasks to orthotic and prosthetic assistants, orthotic and prosthetic technicians and pedorthic support personnel, while the licensee remains ultimately responsible for the completed tasks.
Section 18.853 has been amended to cross-reference the more general provisions in § 16.61. Subsection (b)(11) has been revised to refer to supervision and assistance of unlicensed assistive personnel (orthotic and prosthetic assistants and technicians, and pedorthic support personnel). Subsection (b)(13) has been amended for clarity in response to a comment by IRRC.
Amendments regarding biennial renewal and reactivation
Section 18.861 has been amended to refer to the term of art ''disposition in lieu of trial'' which had been edited by the Legislative Reference Bureau according to the Pennsylvania Code & Bulletin Style Manual. This is a legal term of art used in criminal law that refers to a specific type of disposition of a criminal matter. See, for example, section 18 of The Controlled Substance, Drug, Device and Cosmetic Act (35 P.S. § 780-118). In addition, as requested by IRRC, subsection (b)(5) has been amended to include a cross-reference to section 13.5(g)(2) of the act.
Section 18.862 (relating to continuing education) has been amended to clarify that continuing education courses must be approved by ABC or BOC. The Board also amended subsection (a)(4) to delete the proviso ''if licensure occurred within 3 years of completion of the approved educational program.'' The Board made this change to be consistent with how all other licensure categories are handled.
Section 18.863 (relating to inactive and expired status of licenses; reactivation of inactive or expired license) has been amended to clarify that a licensee whose license has been inactive for more than 2 years and who has not been engaged in practice in another jurisdiction shall demonstrate continued competence by passing the initial certification examination offered by ABC, BOC or another credentialing organization whose certification program is recognized by ICE, accredited by NCCA and approved by the Board. In that BOC announced its intention to discontinue the initial examinations for certification as a prosthetist, orthotist and pedorthist after July 2016, the Board wanted to provide for the possibility of another certification organization entering the field.
Fiscal Impact and Paperwork Requirements
The statutory requirements that prosthetists, orthotists, pedorthists and orthotic fitters obtain and renew licenses to practice, obtain and maintain professional liability insurance and complete continuing education biennially will have a fiscal impact and impose paperwork requirements on the regulated community.
The new requirements will also have a fiscal impact and will impose additional paperwork requirements on the Commonwealth, specifically the Board, which is charged with administering the act. However, the costs to the Board will be recouped through application fees and biennial renewal fees.
Sunset Date
The Board continuously monitors the effectiveness of its regulations. Therefore, a sunset date has not been assigned.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P.S. § 745.5(a)), on June 30, 2014, the Board submitted a copy of the notice of proposed rulemaking, published at 44 Pa.B. 4364, to IRRC and the Chairpersons of the HPLC and the Senate Consumer Protection and Professional Licensure Committee (SCP/PLC) for review and comment.
Under section 5(c) of the Regulatory Review Act, the Board shall submit to IRRC, the HPLC and the SCP/PLC copies of comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Board considered all comments from IRRC, the HPLC and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P.S. § 745.5a(j.2)), on September 14, 2016, the final-form rulemaking was deemed approved by the HPLC and the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on September 15, 2016, and approved the final-form rulemaking.
Contact Person
Interested persons may obtain information regarding the final-form rulemaking by writing to Suzanne Zerbe, Board Administrator, State Board of Medicine, P.O. Box 2649, Harrisburg, PA 17105-2649, ST-MEDICINE@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) and the regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) The amendments to the final-form rulemaking do not enlarge the purpose of the proposed rulemaking published at 44 Pa.B. 4364.
(4) This final-form rulemaking is necessary and appropriate for administration and enforcement of the authorizing acts identified in this preamble.
Order
The Board orders that:
(a) The regulations of the Board, 49 Pa. Code Chapters 16 and 18, are amended by adding §§ 18.801, 18.802, 18.811—18.814, 18.821—18.824, 18.831—18.833, 18.841—18.843, 18.851—18.853 and 18.861—18.864 and amending §§ 16.11 and 16.13 to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(Editor's Note: Proposed §§ 18.815, 18.816, 18.825, 18.826, 18.834, 18.835, 18.844 and 18.845 included in the proposed rulemaking have been withdrawn by the Board.)
(b) The Board shall submit this order and Annex A to the Office of General Counsel and to the Office of Attorney General as required by law.
(c) The Board shall submit this order and Annex A to IRRC, the HPLC and the SCP/PLC as required by law.
(d) The Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(e) This order shall take effect on publication in the Pennsylvania Bulletin.
MARILYN J. HEINE, MD, FACEP, FACP,
Chairperson(Editor's Note: See 46 Pa.B. 6195 (October 1, 2016) for IRRC's approval order.)
Fiscal Note: Fiscal Note 16A-4943 remains valid for the final adoption of the subject regulations.
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