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PA Bulletin, Doc. No. 23-9

RULES AND REGULATIONS

Title 49—PROFESSIONAL AND VOCATIONAL STANDARDS

STATE BOARD OF MEDICINE

[ 49 PA. CODE CH. 18 ]

Orthotic Fitter Temporary Permits and Training

[53 Pa.B. 16]
[Saturday, January 7, 2023]

 The State Board of Medicine (Board) amends §§ 18.841, 18.842 and 18.843 (relating to temporary practice permit; orthotic fitting care experience; and orthotic fitter license) 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

 Section 8 of the Medical Practice Act of 1985 (act) (63 P.S. § 422.8) authorizes the Board to ''adopt such regulations as are reasonably necessary to carry out the purposes of the act.'' The act of July 5, 2012 (P.L. 873, No. 90) (Act 90 of 2012) amended the act to require the Board to issue licenses to prosthetists, orthotists, pedorthists and orthotic fitters; and to regulate the practice of these professions. In 2014, the act of July 2, 2014 (P.L. 941, No. 104) amended provisions of the act regarding orthotists, orthotic fitters, prosthetists and pedorthists. Section 13.5(a) of the act (63 P.S. § 422.13e(a)) sets forth licensing qualifications for orthotic fitters and the other professions. Section 13.5(a)(2)(iv) of the act requires successful completion of a board-approved, entry-level education program specific to orthotic fitting, a minimum of 1,000 hours of documented patient care and certification by an orthotic fitting organization recognized by the Institute for Credentialing Excellence (ICE), accredited by the National Commission for Certifying Agencies (NCCA) or approved by the board. Section 8 of the act authorizes the Board to adopt regulations that are reasonably necessary to carry out the purposes of the act.

Background and Need for Amendments

 In 2016, the Board promulgated regulations to effectuate Act 90 of 2012. Section 18.841(d) of the Board's regulations authorize an individual to practice as an orthotic fitter trainee for a period of up to 12 months prior to passing the orthotic fitter certification examination by means of a temporary practice permit. The Board's regulations do not allow renewal of a temporary practice permit. At their meeting on July 24, 2017, the Board's Allied Health Committee (Committee) met with stakeholders to consider a proposal to extend the period for the holder of an orthotic fitter temporary practice permit from 12 months to 24 months.

 Under the Board's regulations, an orthotic fitter temporary practice permit may be issued to an individual who has completed a board-approved, entry-level education program specific to orthotic fitting. Completion of the 1,000 hours of orthotic fitting care experience is a prerequisite to be eligible to take the orthotic fitter certification examination offered by the two existing Board-approved certification entities, the Board of Certification (BOC) and the American Board of Certification (ABC). Thus, assuming an individual completes the 1,000 hours of experience within the first 25 weeks of the 1-year temporary practice permit, the individual would have 27 weeks to prepare for and pass the examination. Currently, based upon examination requirements, if an individual fails the examination five times, the individual is required to repeat the board-approved, entry-level education program specific to orthotic fitting before attempting to pass the examination for a sixth time.

 There was a question raised as to whether the 27-week period after an individual completes the orthotic fitting care experience is sufficient to allow the temporary practice permit holders to adequately prepare to take the examination. In reviewing this issue, the Board determined that its original intent had been to allow temporary practice permit holders to take the examination up to the five times allowed by the two certification organizations, ABC and BOC. Extending the period that an individual can hold a temporary practice permit from 12 months to 18 months would be consistent with the Board's original intent to allow the temporary practice permit holders to take the test up to five times by providing the permit holders with an additional 6 months to test before the expiration of the initial temporary practice permit. Additionally, the extension from 12 months to 18 months would also be consistent with other states that license orthotic fitters and the national certification standards. Accordingly, the Committee recommended that the Board initiate the process to amend its regulations to extend the period on which the Board voted and approved.

 The Committee further considered a proposal to permit an individual to apply for a second temporary practice permit. However, the Committee was concerned that temporary practice permit holders may attempt to secure a second temporary practice permit without first attempting to take the licensure examination. This would allow the temporary practice permit holder to continue to work without meeting the State licensure requirements. The Committee concluded that the best way to ensure that this would not occur would be to only offer the second temporary practice permit to those individuals who had unsuccessfully attempted the certification examination at least three times. The Board decided further that prior to securing a second temporary practice permit, the individual must retake a Board-approved, entry-level education program specific to orthotic fitting. The Board concluded that this advances public safety by ensuring that unsuccessful examinees demonstrate a second successful completion of the educational program, ensuring that their education is up to date and that previously missing knowledge could be remediated.

Summary and Responses to Comments

 Notice of the proposed rulemaking was published at 51 Pa.B. 180 (January 9, 2021). Publication was followed by a 30-day public comment period during which the Board received one public comment from BOC. In addition, the Independent Regulatory Review Commission (IRRC) submitted comments. The House Professional Licensure Committee (HPLC) and the Senate Consumer Protection and Professional Licensure Committee (SCP/PLC) did not submit comments.

BOC comment

 Zach Chait, the Regulatory and Legislative Analyst from BOC, commented on the proposed rulemaking to suggest some changes to the language relating to the precertification courses for orthotic fitters. Specifically, Zach Chait indicated that neither ICE nor its accreditation arm, NCCA accredit or otherwise recognize specific courses of education, which would make it impossible for orthotic fitters to comply with this requirement. BOC suggests the elimination of this language, in its entirety, to avoid any unintended adverse effects on candidates seeking licensure.

IRRC comment

 IRRC submitted three comments for the Board to address. In response to BOC's comment relating to the education program, IRRC first questions whether the amended language in § 18.841(b)(2) should track the act to say a ''precertification education program approved by a credentialing organization recognized by ICE, accredited by NCCA and approved by the Board.'' IRRC asks the Board to clarify how an individual would comply with this requirement for licensure. In its second comment, IRRC asks the Board to clarify the provision in subsection (d) relating to failure of the examination at least three times. Finally, IRRC questions what ''all faucets'' of orthotic fitting care includes in § 18.842(b) and requests that the Board explain how the regulated community will know if that standard has been met and how it will be verified and implemented by the Board.

§ 18.841(b)(2)

 In response to the comments received by BOC and IRRC, the Board amends § 18.841(b)(2) to clarify educational requirements. Upon review of the comments received, the Board determined that the language the Board proposed related to certification requirements. For the sake of clarity and with the intent to track the act at section 13.5(a)(2)(iv) as it relates to the orthotic fitting education program, the Board amends § 18.841(b)(2), by deleting reference to ''precertification education program whose credentialling is recognized by the ICE, accredited by the NCAA and approved by the Board.'' IRRC suggested that the amended language track the act; the Board agrees. Thus, this final-form rulemaking amends § 18.841(b)(2) to track section 13.5(a)(2)(iv) of the act, which requires successful completion of a Board-approved, entry-level education program specific to orthotic fitting care. The amendments in this final-form rulemaking allow the Board to continue to approve orthotic fitting education programs should new ones come before the Board while continuing to approve the existing ABC and BOC orthotic fitting education programs.

§ 18.841(d)

 IRRC also suggested that the Board amend § 18.841(d) to clarify that an individual must fail the certification examination on at least three attempts before they can apply for a second permit after completing a second approved precertification education program. The Board agrees with IRRC that amending § 18.841(d) to include ''at least three times'' adds clarity; therefore, the Board includes this phase in this final-form rulemaking. For consistency, the Board also amends subsection (d) to delete the proposed language referring to ICE and NCCA to mirror the language used in subsection (b)(2).

§ 18.842(b)

 IRRC's final comment requests clarity on the meaning of ''all facets'' of orthotic fitting care. Facets of orthotic fitting care include the full scope of practice of orthotic fitting. To help clarify this, this final-form rulemaking amends the language in § 18.842(b) to read ''and shall include all facets of the practice of orthotic fitting as defined in § 18.802 (relating to definition of orthotic fitting)." Orthotic fitting is defined as ''the fitting, dispensing, and adjusting of prefabricated orthotic devices pursuant to a written prescription of a licensed prescribing practitioner.'' This amendment clarifies the scope of orthotic fitting care using an already existing definition that can be easily found and relied upon by the regulated community.

§ 18.843(b)

 To keep consistency among all sections of the regulations relating to orthotic fitters, the Board amends § 18.843(b) consistent with the amendments in § 18.841(b)(2) and (d)(2) and changes the language relating to the education program to read, ''a board-approved, entry-level education program specific to orthotic fitting.''

Fiscal Impact

 The amendments allow individuals to apply for a second temporary orthotic fitter practice permit. The application fee for the permit will remain unchanged at $25. This final-form rulemaking will not have any other fiscal impact on licenses. Because the application fee was set to cover the cost of processing the application, it will not have a fiscal impact on the Board. There is no fiscal impact to government generally. Applicants who choose to apply for a second permit will be required to file an application; therefore, additional paperwork will be required for those applicants.

Sunset Date

 The Board continuously monitors its regulations; 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 December 22, 2020, the Board submitted the notice of proposed rulemaking, published at 51 Pa.B. 180 (January 9, 2021), to IRRC and to the Chairpersons of the HPLC and the SCP/PLC. Publication was followed by a 30-day public comment period during which the Board received four public comments.

 Under section 5(c) of the Regulatory Review Act, IRRC, the HPLC and the SCP/PLC were provided with 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 and the public. The HPLC and the SCP/PLC did not submit comments.

 Under section 5.1(a) of the Regulatory Review Act (71 P.S. § 745.5a(a)), on October 5, 2022, the Board delivered this final-form rulemaking to IRRC, the HPLC and the SCP/PLC. 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 November 16, 2022, 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 November 17, 2022, and approved the final-form rulemaking.

Additional information

 Additional information may be obtained by writing to Jasmira Hunter, Board Administrator, State Board of Medicine, P.O. Box 2649, Harrisburg, PA 17105-2649, ST-MEDICINE@pa.gov.

Findings

 The State Board of Medicine finds that:

 (1) Public notice 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), referred to 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) The amendments to this final-form rulemaking do not enlarge the original purpose for the proposed regulation published at 51 Pa.B. 180.

 (4) These amendments to the regulations of the State Board of Medicine are necessary and appropriate for the regulation of the practice of orthotic fitting in the Commonwealth.

Order

The Board, acting under its authorizing statute, orders that:

 (A) The regulations of the State Board of Medicine, 49 Pa. Code Chapter 18, are amended by amending §§ 18.841, 18.842 and 18.843 to read as set forth in Annex A.

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

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

 (D) The Board shall certify this final-form rulemaking and shall 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.

MARK B. WOODLAND, MS, MD, 
Chairperson

 (Editor's Note: See 52 Pa.B. 7487 (December 3, 2022) for IRRC's approval order.)

Fiscal Note: Fiscal Note 16A-4947 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 18. STATE BOARD OF MEDICINE—PRACTITIONERS OTHER THAN MEDICAL DOCTORS

Subchapter L. PROSTHETISTS, ORTHOTISTS, PEDORTHISTS AND ORTHOTIC FITTERS

QUALIFICATIONS FOR LICENSURE AS AN ORTHOTIC FITTER

§ 18.841. Temporary practice permit.

 (a) Prior to providing orthotic fitting care, an individual shall obtain a temporary practice permit authorizing the individual to practice orthotic fitting as an orthotic fitter trainee. An individual shall submit an application for a temporary practice permit on forms made available by the Board. The Board may grant a temporary practice permit to an individual who submits a completed application including the necessary supporting documents, pays the application fee in § 16.13(q) (relating to licensure, certification, examination and registration fees) and meets the qualifications in subsection (b).

 (b) The Board may grant a temporary practice permit to an individual who:

 (1) Is of good moral character.

 (2) Has successfully completed an ABC-approved or BOC-approved orthotic fitter precertification education program or other Board-approved, entry-level education program specific to orthotic fitting. An applicant shall demonstrate completion of an ABC-approved or BOC-approved orthotic fitter precertification education program or other Board-approved, entry-level education program specific to orthotic fitting by having the educational institution submit, directly to the Board, verification of completion.

 (c) The Board may deny an application for a temporary practice permit upon the grounds for disciplinary action in section 41 of the act (63 P.S. § 422.41), § 16.61 or § 18.853 (relating to unprofessional and immoral conduct) or other applicable law, such as 18 Pa.C.S. § 9124 (relating to use of records by licensing agencies).

 (d) A temporary practice permit is valid for a maximum of 18 months. An individual who has failed the certification examination at least three times and whose temporary practice permit has expired may apply for a second temporary practice permit after retaking one of the following:

 (1) ABC-approved or BOC-approved orthotic fitter precertification education program.

 (2) A Board-approved, entry-level education program specific to orthotic fitting.

 (e) The second temporary practice permit is valid for a maximum of 12 months. An individual may not receive a third or subsequent temporary practice permit.

 (f) An individual holding a temporary practice permit may use the title ''orthotic fitter trainee'' and shall inform patients that the individual is completing a training program and is not fully licensed.

§ 18.842. Orthotic fitting care experience.

 (a) An orthotic fitter trainee with a temporary practice permit shall practice only under the direct supervision of an orthotist or orthotic fitter licensed by the Board. For purposes of this section, ''direct supervision'' means the supervisor is available for consultation throughout the patient care process and is able to visually assess the care being provided. The supervisor shall review the results of care and the documentation of the services rendered by the orthotic fitter trainee and is responsible for countersigning within 15 days the entries in the patient's clinical record.

 (b) The orthotic fitting care experience shall be obtained subsequent to education and shall include all facets of the practice of orthotic fitting as defined in § 18.802 (relating to definitions).

§ 18.843. Orthotic fitter license.

 (a) An applicant for a license to practice as an orthotic fitter shall submit, on forms made available by the Board, a completed application for licensure, including the necessary supporting documents, and pay the application fee in § 16.13(q) (relating to licensure, certification, examination and registration fees).

 (b) The Board may issue a license to practice as an orthotic fitter to an applicant who:

 (1) Is of good moral character.

 (2) Has successfully completed an ABC-approved or BOC-approved orthotic fitter precertification education program or other Board-approved, entry-level education program specific to orthotic fitting. Unless previously submitted under § 18.841 (relating to temporary practice permit), an applicant shall demonstrate completion of an ABC-approved or BOC-approved orthotic fitter precertification education program or other Board-approved, entry-level education program specific to orthotic fitting by having the educational institution submit, directly to the Board, verification of completion.

[Pa.B. Doc. No. 23-9. Filed for public inspection January 6, 2023, 9:00 a.m.]



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