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PA Bulletin, Doc. No. 14-235

RULES AND REGULATIONS

STATE BOARD OF OSTEOPATHIC MEDICINE

[ 49 PA. CODE CH. 25 ]

Physician Assistants and Respiratory Therapists

[44 Pa.B. 589]
[Saturday, February 1, 2014]

 The State Board of Osteopathic Medicine (Board) amends §§ 25.141, 25.142, 25.161, 25.163, 25.176, 25.191, 25.192, 25.201, 25.215, 25.231, 25.501—25.509, 25.509a, 25.509b and 25.510 and adds § 25.164 (relating to professional liability insurance coverage for licensed physician assistants) 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 final-form rulemaking is authorized under sections 10(f) and (h), 10.1(c), 10.2(f) and 16 of the Osteopathic Medical Practice Act (act) (63 P. S. §§ 271.10(f) and (h), 271.10a(c), 271.10b(f) and 271.16).

Background and Need for the Final-Form Rulemaking

 The act of July 4, 2008 (P. L. 589, No. 46) (Act 46) amended the act to change references to the ''certification of respiratory care practitioners'' to ''licensure of respiratory therapists'' and revised the standards for licensure as a respiratory therapist and for receipt of a temporary practice permit. Act 46 also identified additional specific acts of practice for physician assistants and required physician assistants to complete continuing education and maintain professional liability insurance. Additionally, the act of July 2, 2004 (P. L. 486, No. 56) (Act 56) amended section 10(f) of the act to provide that the Board shall grant licensure, rather than certification, to physician assistants. This final-form rulemaking amends the Board's regulations to implement these changes.

Summary of Comments to Proposed Rulemaking and the Board's Response

 The Board published the proposed rulemaking at 42 Pa.B. 2474 (May 12, 2012) with a 30-day public comment period. The Board received public comments from the Pennsylvania Society for Respiratory Care, Inc. (PSRC). The Board also received comments from the House Professional Licensure Committee (HPLC) and the Independent Regulatory Review Commission (IRRC) as part of their review under the Regulatory Review Act (71 P. S. §§ 745.1—745.12).

Comments from the PSRC

 The PSRC sent the Board four comments on June 7, 2012. Regarding § 25.507(1)(i) (relating to criteria for licensure as a respiratory therapist), the PSRC requested the Board identify the ''credentialing examination'' as the examination for entry to practice rather than the ''CRTT.'' IRRC agreed. In addition to making this change, the Board similarly clarified the examination in § 25.506(b) (relating to temporary permits), a necessary amendment noted by the HPLC.

 The PSRC also recommended that the Board delete § 25.506. The PSRC opined that temporary permits are unnecessary because graduates may now schedule the entry level examination immediately upon graduation. Act 46 revised qualifications of applicants for a temporary permit so that section 10.2(b) of the act sets forth the criteria for the Board issuing a temporary permit to individuals who have applied for licensure and section 10.2(c) of the act sets forth the duration and effect of temporary permits. These amendments indicate that the General Assembly has reaffirmed the viability of temporary permits for respiratory therapists and, accordingly, the Board believes that it lacks statutory authority to eliminate temporary permits.

 In addition, the Board believes there is some value to retaining temporary permits. A temporary permit to practice is valid for 12 months, unless the holder fails the entry level credentialing examination. Upon notification to the permit holder that the examination attempt was not successful, the permit becomes null and void. An applicant is not required to obtain a temporary permit, but may apply for a temporary permit to allow practice prior to the time the applicant takes the licensing examination, while the applicant is waiting for the examination results or while the applicant's application for licensure is being processed. In short, a temporary permit bridges a time gap that may occur between graduation and licensure and allows graduates to become employed without delay.

 The PSRC also recommended changes to § 25.509a (relating to requirement of continuing education). The PSRC questioned whether this subsection applied to new graduates. In response, the Board rewrote subsection (b) for clarity to read: ''An individual applying for the first time for licensure in this Commonwealth is exempt from completing the continuing education requirements during the initial biennial renewal period in which the license is issued.'' This language exempts from the continuing education requirement the three types of applicants who may obtain initial Pennsylvania licensure: 1) new graduates from this Commonwealth; 2) new graduates from other states; and 3) licensees in other states who are seeking licensure in this Commonwealth.

 The PSRC suggested eliminating the exemption for licensees in other states who are seeking licensure in this Commonwealth who are not ''new graduates.'' The Board declines to make this change. Continuing education is required for license renewal in the 48 states where respiratory therapists are licensed. If a practicing respiratory therapist from another state applies for a license in this Commonwealth and has not taken as many hours of continuing education as now required in this Commonwealth, that individual will still have both experience and knowledge gained while practicing in another state. The exemption is applied to only the first biennial renewal period for the allied health professionals licensed by the Board. Finally, eliminating the exemption would be time consuming and difficult for the Board to administer because it would require the Board to distinguish between licensees whose initial license was granted in this Commonwealth and licensees whose initial license was granted by another state. For these reasons, the Board maintains that the new language it has added to § 25.509a(b) clarifies this subsection and that further changes are not necessary or warranted.

 The PSRC asked the Board to approve advanced life support courses accredited by the American Heart Association (AHA) or similar groups in § 25.509b(a) (relating to approved educational programs). AHA advanced life support courses are approved by the American Medical Association (AMA). Section 25.509b(a) already provides approval for AMA-approved continuing education programs. Therefore, AHA advanced life support courses are already approved as continuing education for respiratory therapists.

Comments from the HPLC

 On June 13, 2012, the HPLC submitted comments. The first comment noted the Board's timing for the submission of the proposed rulemaking. The Board respectfully understands the Committee's comments and will work to provide more timely proposed rulemakings in the future.

 Second, as noted previously, the HPLC suggested that with the deletion of ''CRTT'' from § 25.502 (relating to definitions), § 25.506(b) should be amended to refer to the ''credentialing examination.'' The Board made this change and also amended § 25.507(1)(i) to add ''entry level'' before ''credentialing examination'' to accurately identify the required examination.

Comments from IRRC

 On July 11, 2012, IRRC submitted seven comments. IRRC pointed out that the ''Note'' section of Act 46 requires the Board and the State Board of Medicine to jointly promulgate these regulations. The act and the Medical Practice Act of 1985 (63 P. S. §§ 422.1—422.51a) authorize each board to license and regulate only those who practice under each act, respectively. The amendments to each act in the act of July 4, 2008 (P. L. 580, No. 45) and Act 46 do not change which board licenses and regulates the professionals under the jurisdiction of each board. Likewise, the Board and the State Board of Medicine do not jointly license or regulate the professionals under the jurisdiction of each board. The Board and the State Board of Medicine promulgated similar proposed rulemakings and now adopt substantially identical final-form rulemakings. By promulgating the final-form rulemakings at the same time, the statutorily mandated changes will be effective at the same time, regardless of which board has jurisdiction over an individual practitioner. The Board believes this process meets with the statutory intent.

 With respect to Subchapter C (relating to physician assistant provisions), IRRC raised two issues. IRRC noted that § 25.163(c) (relating to approval and effect of licensure; biennial renewal of physician assistants; registration of supervising physicians) requires physician assistants to maintain National certification and recommended that the final-form rulemaking should identify the recertification mechanisms recognized by the Board or identify how a physician assistant can access this information. The Board adds to the first sentence of this subsection a reference to the National Commission on Certification of Physician Assistants (NCCPA) and directs physician assistants to the NCCPA's web site (www.nccpa.net) to access the information.

 IRRC recommended that the Board clarify where it will publish future recognition of an organization's certification of physician assistants. The Board addressed this request in § 25.163(c), noting that additional National certification of an organization will be announced on the Board's web site (www.dos.state.pa.us/ost).

 IRRC's remaining comments addressed Subchapter K (relating to respiratory therapists). IRRC indicated some confusion in § 25.506(a), which refers to an individual ''who is recognized as a credentialed respiratory therapist. . . .'' (Emphasis added by IRRC.) The Board amended this subsection to clarify that an applicant for a temporary permit would not yet be a licensee of the Board. The reference to a ''credentialed respiratory therapist'' is intended to mean an individual who holds one of the credentials issued by the National Board for Respiratory Care.

 Regarding § 25.506(b), IRRC echoed the suggestion made by the HPLC to replace ''CRTT'' with ''credentialing examination.'' The change has been made. IRRC also agreed with the PSRC's comment regarding replacing ''credentialing examination'' with ''entry level credentialing examination,'' changes which were also made to § 25.507(1)(i).

 IRRC made two recommendations regarding § 25.509a. IRRC recommended that the Board address in the Regulatory Analysis Form (RAF) additional costs that the increase in the minimum number of mandatory continuing education hours will impose on the regulated community. The Board added this analysis in the RAF. Many courses are offered free of charge or at low cost through the American Association for Respiratory Care (AARC). Most hospital respiratory therapy departments sponsor lectures at their facilities for their staff to attend at no charge and some offer ''grand rounds'' in their intensive care units. Print publications (such as Saxe Healthcare Communications at www.saxetesting.com) are also offered online at no charge. Because many courses are offered free of charge or at a low price, the Board estimates a cost of $10 per credit hour, for a total additional cost of $100 per licensee during a biennial renewal period or $50 per year. Respiratory therapists may receive free or low cost continuing education by joining the AARC at a cost of $90 annually. If one assumes that a licensee joins AARC primarily to receive low cost or free continuing education, then the total estimated cost of continuing education and AARC membership is $140 a year.

 IRRC recommended consistency between the Board's proposal that no more than 10 hours of creditable continuing education may be earned through nontraditional sources (prerecorded presentations, Internet-based presentations and journal review programs) and the State Board of Medicine's proposal that there be no restriction on these hours. The Board and the State Board of Medicine have agreed to identical language requiring at least 10 hours of continuing education be earned in traditional continuing education (classroom lecture, clinical presentation, real-time web-cast or other live sessions where a presenter is involved) to ensure consistent standards between the Board and the State Board of Medicine.

 IRRC also recommended that the Board define ''practice building.'' The Board added the definition in § 25.502 as ''marketing or any other activity that has as its primary purpose increasing the business volume or revenue of a licensee or the licensee's employer.''

 IRRC suggested that the Board's description of amendments to the final-form rulemaking address first physician assistant provisions, followed by the respiratory therapist provisions. The Board has done so.

 IRRC asked the Board to add Purdon's citations to § 25.164(c) and (d) and § 25.505(b) (relating to functions of respiratory therapists). The Board confirmed with the Legislative Reference Bureau that the proposed rulemaking is correct. Purdon's citations to a cross-referenced statute are to appear only the first time the section of the act is referenced within a particular section of a regulation. The first citation applies to all subsequent references to the same statutory section or any subsection or paragraph of the section. Accordingly, the Board did not make the requested additions.

Description of Amendments to the Final-Form Rulemaking

 The Board amended § 25.142 (relating to definitions) to further define ''NCCPA'' as the organization recognized by the Board to certify and recertify physician assistants by requiring continuing education and examination. The Board added information to § 25.163 to direct applicants to NCCPA's web site for information regarding maintaining current certification with that organization and clarified that it will publish recognition of additional National organizations on the Board's web site.

 The remaining changes in the final-form rulemaking are in Subchapter K. The Board added a definition of ''practice building'' in § 25.502.

 In § 25.506, the Board clarified that a temporary permit will be issued to an applicant who is not yet a licensee of the Board. Furthermore, as requested by the PSRC, the HPLC and IRRC, the Board replaced ''CRTT'' with ''entry level credentialing examination'' in §§ 25.506(b) and 25.507(1)(i).

 The Board amends § 25.509a(a)(3) to make the traditional and nontraditional continuing education requirements the same for both the Board and the State Board of Medicine. The provision provides that respiratory therapists shall complete at least 10 hours of traditional continuing education such as classroom lecture, clinical presentation, real-time web-case or other sessions where a presenter is involved to meet the biennial continuing education requirement.

 The Board amended § 25.509a(b) to clarify that new licensees are exempt from the continuing education requirement for the first biennial renewal period. The new language states: ''An individual applying for the first time for licensure in this Commonwealth is exempt from completing the continuing education requirements during the initial biennial renewal period in which the license is issued.''

Fiscal Impact and Paperwork Requirements

 There are minimal fiscal impacts upon physician assistants because physician assistants are already required to complete continuing education to maintain National certification and because virtually all physician assistants already hold professional liability insurance. There will not be adverse fiscal impact on the Commonwealth or its political subdivisions. Likewise, the amendments in this final-form rulemaking will not impose additional paperwork requirements upon the Commonwealth, political subdivisions or the private sector. The final-form rulemaking will have only a minor fiscal impact on respiratory therapists who shall take an additional 10 credit hours of continuing education during a biennial period and may impact those small businesses who pay continuing education costs for employed respiratory therapists.

Sunset Date

 The Board continuously monitors 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 May 2, 2012, the Board submitted a copy of the notice of proposed rulemaking, published at 42 Pa.B. 2474, 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, 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, the HPLC, the SCP/PLC and the public.

 Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on December 11, 2013, the final-form rulemaking was approved by the HPLC. On December 11, 2013, the final-form rulemaking was deemed approved by the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on December 12, 2013, and approved the final-form rulemaking.

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 42 Pa.B. 2474.

 (4) This final-form rulemaking is necessary and appropriate for administering and enforcing the authorizing act identified in this preamble.

Order

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

 (a) The regulations of the Board, 49 Pa. Code Chapter 25, are amended by adding § 25.164 and amending §§ 25.141, 25.142, 25.161, 25.163, 25.176, 25.191, 25.192, 25.201, 25.215, 25.231, 25.501—25.509, 25.509a, 25.509b and 25.510 are amended to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.

 (b) The Board shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General as required by law.

 (c) The Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.

 (d) This order shall take effect immediately upon publication in the Pennsylvania Bulletin.

JEFFREY A. HEEBNER, DO, 
Chairperson

 (Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 43 Pa.B. 7606 (December 28, 2013).)

Fiscal Note: Fiscal Note 16A-5321 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 25. STATE BOARD OF OSTEOPATHIC MEDICINE

Subchapter C. PHYSICIAN ASSISTANT PROVISIONS

GENERAL PROVISIONS

§ 25.141. Purpose.

 The purpose of this subchapter is to implement the provisions of the act which provide for the licensure of physician assistants. The legislation provides for more effective utilization of certain skills of osteopathic physicians enabling them to delegate certain medical tasks to qualified physician assistants when such delegation is consistent with the patient's health and welfare.

§ 25.142. Definitions.

 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:

Certification—The approval of a program by the Board for the training and education of physician assistants.

Direct supervision—The physical presence of the supervising physician on the premises so that the supervising physician is immediately available to the physician assistant when needed. Where emergency rooms are concerned, direct supervision requires the presence of the supervising physician in the emergency room suite.

NCCPA—The National Commission on Certification of Physician Assistants, the organization recognized by the Board to certify and recertify physician assistants by requiring continuing education and examination.

Protocol—Written treatment instructions prepared by the supervising osteopathic physician for use by the physician assistant, containing a detailed description of the manner in which the physician assistant will assist the physician in his practice, a list of functions to be delegated to the physician assistant including the procedures enumerated in § 25.171(a) (relating to generally) and other specified delegated tasks, detailed instructions for the use of the physician assistant in the performance of delegated tasks, the method and frequency of supervision and the geographic location where the physician assistant will serve.

Registration—The approval by the Board of an osteopathic physician, licensed to practice osteopathic medicine and surgery without restriction, to supervise and utilize a specified physician assistant.

Satellite operations—An office or clinic separate and apart from the office of the supervising physician established by the physician and manned exclusively by a physician assistant.

Supervising physician—A physician licensed to practice osteopathic medicine and surgery in this Commonwealth who registers with the Board and who accepts the responsibility for the supervision of services rendered by physician assistants.

Supervision—The opportunity or ability of the physician, or in his absence a substitute supervising physician, to provide or exercise control and direction over the services of physician assistants. Constant physical presence of the supervising physician on the premises is not required so long as the supervising physician and the physician assistant are or can easily be in contact with each other by radio, telephone or telecommunication. Supervision requires the availability of the supervising physician to the physician assistant. An appropriate degree of supervision includes:

 (i) Active and continuing overview of the physician assistant's activities to determine that the physician's directions are being implemented.

 (ii) Immediate availability of the supervising physician to the physician assistant for necessary consultations.

 (iii) Personal and regular—at least weekly—review by the supervising physician of the patient records upon which entries are made by the physician assistant.

 (iv) Periodic—at least monthly—education and review sessions held by the supervising physician for the physician assistant under his supervision for discussion of specific conditions, protocols, procedures and specific patients.

Written agreement—The agreement between the physician assistant and supervising physician, which satisfies the requirements of § 25.162(a)(4) (relating to criteria for registration as supervising physician).

LICENSURE OF PHYSICIAN ASSISTANTS AND REGISTRATION OF SUPERVISING PHYSICIANS

§ 25.161. Criteria for licensure as a physician assistant.

 (a) The Board has approved as a proficiency examination the national certification examination on primary care developed by the NCCPA. The Board will maintain a current register of approved proficiency examinations. This register will list the full name of the examination, the organization giving the examination, the mailing address of the examination organization and the date the proficiency examination received Board approval. This register shall be available for public inspection.

 (b) The clinical experience required by the Board is at present identical to the clinical experience required by the NCCPA for taking the NCCPA examination on primary care. To qualify for an NCCPA proficiency examination, the applicant's employment history must be verified by the NCCPA in cooperation with the Board and must be evaluated by the NCCPA in relation to specific work criteria.

 (c) The Board will approve for licensure as a physician assistant an applicant who:

 (1) Is of good moral character and reputation.

 (2) Has graduated from a physician assistant training program certified by the Board.

 (3) Has submitted a completed application detailing his education and work experience, together with the required fee.

 (4) Has passed a proficiency examination approved by the Board.

 (d) The physician assistant may amend information regarding his education and work experience submitted under the requirements of subsection (c)(3), by submitting to the Board in writing additional detailed information. No additional fee will be required. The file for each physician assistant will be reviewed by the Board to determine whether the physician assistant possesses the necessary skills to perform the tasks that a physician, applying for registration to supervise and utilize the physician assistant, intends to delegate to him as set forth in the protocol contained in the physician's application for registration.

 (e) A person who has been licensed as a physician assistant by the State Board of Medicine shall make a separate application to the Board if he intends to provide physician assistant services for a physician licensed to practice osteopathic medicine and surgery without restriction.

 (f) An application for licensure as a physician assistant by the Board may be obtained by writing to the Harrisburg office of the Board.

§ 25.163. Approval and effect of licensure; biennial renewal of physician assistants; registration of supervising physicians.

 (a) Upon approval of an application for licensure as a physician assistant, the Board will issue a physician assistant license which contains the licensee's name, license number and the date of issuance, after payment of the fee required under § 25.231 (relating to schedule of fees).

 (b) A physician assistant's right to continue practicing is conditioned upon biennial renewal and the payment of the fee required under § 25.231. Upon receipt of the form provided to the physician assistant by the Board in advance of the renewal period and the required fee, the Board will issue the physician assistant a biennial renewal certificate containing the licensee's name, license number and the beginning and ending dates of the biennial renewal period.

 (c) To be eligible for renewal of a physician assistant license, the physician assistant shall complete continuing medical education as required by NCCPA and maintain National certification by completing current certification and recertification mechanisms available to the profession, identified on NCCPA's web site and recognized by the Board. The Board recognizes certification through NCCPA and its successor organizations and certification through any other National organization for which the Board publishes recognition of the organization's certification of physician assistants on the Board's web site.

 (d) Upon approval of an application for registration as a supervising physician, the Board will issue a supervising physician registration certificate which contains the name of the supervising physician, his registration number and the name of the physician assistant that he is authorized to supervise under that specific registration. The registration is not subject to renewal. When the physician submits a request to modify a protocol with respect to a physician assistant he is already registered to utilize, no new registration certificate will be issued; however, the physician will receive a letter from the Board confirming its approval of the expanded utilization.

 (e) Only a physician registered with the Board may use the services of physician assistants. A physician assistant shall have a clearly identified supervising physician who is professionally and legally responsible for the physician assistant's services. Whenever a physician assistant is employed by a professional corporation or partnership, an individual physician must still register as the supervising physician. Each member of a professional corporation or partnership may register as a supervising physician. When a physician assistant is employed by a professional corporation or partnership, the registered supervising physician is not relieved of the professional and legal responsibility for the care and treatment of patients attended by the physician assistant under his supervision.

 (f) The Board will keep a current register of persons licensed as physician assistants. This register will include the name of each physician assistant, the physician assistant's mailing address of record, current business address, the date of initial licensure, biennial renewal record and current supervising physician. This register is available for public inspection.

 (g) The Board will keep a current register of approved registered supervising physicians. This register will include the physician's name, his mailing address of record, his current business address, the date of his initial registration, his satellite operation if applicable, the names of current physician assistants under his supervision and the names of physicians willing to provide substitute supervision in his absence. This register will be available for public inspection.

§ 25.164. Professional liability insurance coverage for licensed physician assistants.

 (a) A licensed physician assistant shall maintain a level of professional liability insurance coverage as required under section 10(g.3) of the act (63 P. S. § 271.10(g.3)).

 (b) Proof of professional liability insurance coverage may include:

 (1) A certificate of insurance or copy of the declaration page from the applicable insurance policy setting forth the effective date, expiration date and dollar amounts of coverage.

 (2) Evidence of a plan of self-insurance approved by the Insurance Commissioner of the Commonwealth under regulations of the Insurance Department in 31 Pa. Code Chapter 243 (relating to medical malpractice and health-related self-insurance plans).

 (c) A license that was issued in reliance upon a letter from the applicant's insurance carrier indicating that the applicant will be covered against professional liability effective upon the issuance of the applicant's license as permitted under section 10(g.3)(2) of the act will become inactive as a matter of law 30 days after issuance of the license if the licensee has not provided proof of professional liability insurance coverage and will remain inactive until the licensee provides proof of insurance coverage.

 (d) A licensee who does not have professional liability insurance coverage as required under section 10(g.3) of the act may not practice as a physician assistant in this Commonwealth.

PHYSICIAN ASSISTANT UTILIZATION

§ 25.176. Monitoring and review of physician assistant utilization.

 (a) Designated representatives of the Board will be authorized to make on-site visits to the office of registered supervising physicians and medical care facilities utilizing physician assistants to review the following:

 (1) Supervision of physician assistants.

 (2) Maintenance of the protocols and compliance with them.

 (3) Utilization in conformity with the provisions of this subchapter.

 (4) Identification of physician assistants.

 (5) Compliance with certification and registration requirements.

 (b) Reports shall be submitted to the Board and become a permanent record under the supervising physician's registration. Deficiencies reported shall be reviewed by the Board and may provide a basis for disciplinary action against the license of the physician assistant and the license or registration, or both, of the supervising physician.

 (c) The Board reserves the right to review physician assistant utilization and records associated therewith, including patient records, without prior notice to either the physician assistant or the registered supervising physician. It will be considered a violation of this subchapter for a supervising physician to refuse to undergo a review by the Board.

PHYSICIAN ASSISTANT REQUIREMENTS IN EMPLOYMENT

§ 25.191. Physician assistant identification.

 (a) No physician assistant may render medical services nor a permitted task as set forth in this chapter to a patient until the patient has been informed of the following:

 (1) That the physician assistant is not a physician.

 (2) That the physician assistant may perform the services required as an employee of the physician and as directed by the supervising physician.

 (3) That the patient has the right not to be treated by the physician assistant if he so desires.

 (b) It shall be the supervising physician's responsibility to ensure that patients are apprised of subsection (a) and it shall further be his responsibility to be alert to patient complaints concerning the type or quality of services provided by the physician assistant.

 (c) In the supervising physician's office and a satellite operation, a notice plainly visible to patients shall be posted in a prominent place explaining the meaning of the term ''physician assistant.'' The supervising physician shall display his registration to supervise the office. The physician assistant's license shall be prominently displayed in all facilities in which he may function. Duplicate certificates may be obtained from the Board if required.

 (d) The physician assistant shall wear an identification tag which uses the term ''Physician Assistant,'' in 16 point type or larger, conspicuously worn.

§ 25.192. Notification of termination of employment; change of address.

 (a) The physician assistant is required to notify the Board of a termination of employment or change of mailing address within 15 days. Failure to notify the Board, in writing, of change in mailing address may result in failure to receive pertinent material distributed by the Board.

 (b) The supervising physician is required to notify the Board of a termination of his supervision of a physician assistant within 15 days.

 (c) Failure to notify the Board of a termination in the physician/physician assistant relationship shall provide a basis for disciplinary action against the physician assistant's license, the supervising physician's license or registration as a supervising physician.

DISCIPLINARY ACTION AGAINST LICENSE OF PHYSICIAN ASSISTANT

§ 25.201. Grounds for complaint.

 (a) The bases upon which the Board may take disciplinary action against the license of a physician assistant are set forth in section 15(b) of the act (63 P. S. § 271.15(b)). A complaint against a physician assistant shall allege that the physician assistant is performing tasks in violation of statute, regulation or good and acceptable standards of practice of physician assistants. The grounds include those specifically enumerated in section 15(b) of the act. Unprofessional conduct shall include, but is not limited to, the following:

 (1) Misrepresentation or concealment of a material fact in obtaining a license or a reinstatement thereof.

 (2) Commission of an offense under a statute of the Commonwealth relating to the practice of physician assistants or under this chapter.

 (3) The commission of an act involving moral turpitude, dishonesty or corruption when the act directly or indirectly affects the health, welfare or safety of citizens of the Commonwealth. If the act constitutes a crime, conviction thereof in a criminal proceeding will not be a condition precedent to disciplinary action.

 (4) Conviction of a felony, defined as such under the statute of the Commonwealth or under the laws of another state, territory or country.

 (5) Misconduct in his practice as a physician assistant or performing a task fraudulently, beyond its authorized scope, with incompetence or with negligence on a particular occasion or on repeated occasions.

 (6) Performing tasks as a physician assistant while the ability to do so is impaired by alcohol, drugs, physical disability or mental instability.

 (7) Impersonation of a licensed physician or another licensed physician assistant.

 (8) The offering, undertaking or agreeing to cure or treat disease by a secret method, procedure, treatment or medicine; the treating or prescribing for a human condition by a method, means or procedure which the physician assistant refuses to divulge upon demand of the Board; or the use of methods or treatment which are not in accordance with treatment processes accepted by a reasonable segment of the medical profession.

 (9) Violation of this chapter fixing a standard of professional conduct.

 (b) Subsection (a) supplements 1 Pa. Code § 35.10 (relating to form and content of formal complaints).

Subchapter D. MINIMUM STANDARDS OF PRACTICE

§ 25.215. Definitions.

 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:

Board-regulated practitioner—An osteopathic physician, perfusionist, physician assistant, respiratory therapist, athletic trainer, acupuncturist or an applicant for a license or certificate issued by the Board.

Immediate family member—A parent or guardian, child, sibling, spouse or other family member, whether related by blood or marriage, with whom a patient resides.

Sexual behavior—Any sexual conduct which is nondiagnostic and nontherapeutic; it may be verbal or physical and may include expressions of thoughts and feelings or gestures that are sexual in nature or that reasonably may be construed by a patient as sexual in nature.

Sexual exploitation—Any sexual behavior that uses trust, knowledge, emotions or influence derived from the professional relationship.

Subchapter F. FEES

§ 25.231. Schedule of fees.

 An applicant for a license, certificate, registration or service shall pay the following fees at the time of application:

*  *  *  *  *

 Application for physician assistant license
$30

*  *  *  *  *

Subchapter K. RESPIRATORY THERAPISTS

§ 25.501. Purpose.

 This subchapter implements sections 10.1 and 10.2 of the act (63 P. S. §§ 271.10a and 271.10b), which were added by section 3 of the act of July 2, 1993 (P. L. 418, No. 59) to provide for the licensure of respiratory therapists.

§ 25.502. Definitions.

 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:

AARC—American Association for Respiratory Care, an organization which provides continuing professional development programs.

AMA—American Medical Association, an organization which provides continuing professional development programs.

AOA—American Osteopathic Association, an organization which provides continuing professional development programs.

Act—The Osteopathic Medical Practice Act (63 P. S. §§ 271.1—271.18).

CoARC—The Committee on Accreditation for Respiratory Care, an organization which accredits respiratory care programs.

CSRT—Canadian Society of Respiratory Therapists, an organization which provides continuing professional development programs.

NBRC—The National Board for Respiratory Care, the agency recognized by the Board to certify respiratory therapists.

Practice building—Marketing or any other activity that has as its primary purpose increasing the business volume or revenue of a licensee or the licensee's employer.

Respiratory therapist—A person who has been licensed in accordance with the act and this subchapter.

§ 25.503. Fees.

 The following is the schedule of fees charged by the Board:

 (1) Temporary permit
$30

 (2) Initial license application
$30

 (3) Licensure examination
$100

 (4) Reexamination
$60

 (5) Biennial renewal of licensure
$25

§ 25.504. Licensure of respiratory therapists; practice; exceptions.

 (a) A person may not practice or hold himself out as being able to practice as a respiratory therapist in this Commonwealth unless the person holds a valid, current temporary permit or license issued by the Board, or the State Board of Medicine under Chapter 18 (relating to State Board of Medicine—practitioners other than medical doctors), or is exempted under section 10.1(e) of the act (63 P. S. § 271.10a(e)) or section 13.1(e) of the Medical Practice Act of 1985 (63 P. S. § 422.13a(e)).

 (b) A person may not use the words ''licensed respiratory therapist'' or ''respiratory care practitioner,'' the letters ''LRT,'' ''RT'' or ''RCP'' or similar words and related abbreviations to imply that respiratory care services are being provided, unless the services are provided by a respiratory therapist who holds a valid, current temporary permit or license issued by the Board or the State Board of Medicine and only while working under the supervision of a licensed physician.

§ 25.505. Functions of respiratory therapists.

 (a) Under section 10.1(d) of the act (63 P. S. § 271.10a(d)), a respiratory therapist may implement direct respiratory care to an individual being treated by either a licensed medical doctor or a licensed doctor of osteopathic medicine, upon prescription or referral by a physician, certified registered nurse practitioner or physician assistant, or under medical direction and approval consistent with standing orders or protocols of an institution or health care facility. This care may constitute indirect services such as consultation or evaluation of an individual and also includes, but is not limited to, the following services:

 (1) Administration of medical gases.

 (2) Humidity and aerosol therapy.

 (3) Administration of aerosolized medications.

 (4) Intermittent positive pressure breathing.

 (5) Incentive spirometry.

 (6) Bronchopulmonary hygiene.

 (7) Management and maintenance of natural airways.

 (8) Maintenance and insertion of artificial airways.

 (9) Cardiopulmonary rehabilitation.

 (10) Management and maintenance of mechanical ventilation.

 (11) Measurement of ventilatory flows, volumes and pressures.

 (12) Analysis of ventilatory gases and blood gases.

 (b) Under section 10.1(d) of the act, a respiratory therapist may perform the activities listed in subsection (a) only upon prescription or referral by a physician, certified registered nurse practitioner or physician assistant or while under medical direction consistent with standing orders or protocols in an institution or health care facility.

§ 25.506. Temporary permits.

 (a) A temporary permit will be issued to an applicant, who is not yet a licensee, who submits evidence satisfactory to the Board, on forms supplied by the Board, that the applicant has met one or more of the following criteria:

 (1) Has graduated from a respiratory care program approved by the CoARC.

 (2) Is enrolled in a respiratory care program approved by the CoARC and expects to graduate within 30 days of the date of application to the Board for a temporary permit.

 (3) Meets the applicable requirements and is recognized as a credentialed respiratory therapist by the NBRC.

 (b) A temporary permit is valid for 12 months and for an additional period as the Board may, in each case, specially determine except that a temporary permit expires if the holder fails the entry level credentialing examination. An applicant who fails the entry level credentialing examination may apply to retake it.

§ 25.507. Criteria for licensure as a respiratory therapist.

 The Board will approve for licensure as a respiratory therapist an applicant who:

 (1) Submits evidence satisfactory to the Board, on forms supplied by the Board, that the applicant has met one or more of the following criteria:

 (i) Has graduated from a respiratory care program approved by the CoARC and passed the entry level credentialing examination as determined by the NBRC.

 (ii) Holds a valid license, certificate or registration as a respiratory therapist in another state, territory or the District of Columbia which has been issued based on requirements substantially the same as those required by the Commonwealth, including the examination requirement.

 (2) Has paid the appropriate fee in a form acceptable to the Board.

§ 25.508. Change of name or address.

 A licensee shall inform the Board in writing within 10 days of a change of name or mailing address.

§ 25.509. Renewal of licensure.

 (a) A license issued under this subchapter expires on December 31 of every even-numbered year unless renewed for the next biennium.

 (b) Biennial renewal forms and other forms and literature to be distributed by the Board will be forwarded to the last mailing address given to the Board.

 (c) To retain the right to engage in practice, the licensee shall renew licensure in the manner prescribed by the Board, pay the required fee and comply with the continuing education requirement of § 25.509a (relating to requirement of continuing education), prior to the expiration of the current biennium.

 (d) When a license is renewed after December 31 of an even-numbered year, a penalty fee of $5 for each month or part of a month of practice beyond the renewal date will be charged in addition to the renewal fee.

§ 25.509a. Requirement of continuing education.

 (a) An applicant for biennial renewal or reactivation of licensure is required to complete a minimum of 30 hours of continuing education as set forth in section 10.2(f)(2) of the act (63 P. S. § 271.10b(f)(2)) subject to the following:

 (1) At least 10 continuing education hours shall be obtained through traditional continuing education such as classroom lecture, clinical presentation, real-time web-cast or other live sessions where a presenter is involved. For nontraditional continuing education such as prerecorded presentations, Internet-based presentations and journal review programs, to qualify for credit, the provider shall make available documented verification of completion of the course or program.

 (2) One hour must be completed in medical ethics, and 1 hour must be completed in patient safety.

 (3) Credit will not be given for continuing education in basic life support, including basic cardiac life support and cardiopulmonary resuscitation. In any given biennial renewal period, a licensee may receive credit for no more than 8 continuing education hours in advanced life support, including advanced cardiac life support, neonatal advanced life support/neonatal resuscitation and pediatric advanced life support.

 (4) A licensee will not receive continuing education credit for participating in a continuing education activity with objectives and content identical to those of another continuing education activity within the same biennial renewal period for which credit was granted.

 (b) An individual applying for the first time for licensure in this Commonwealth is exempt from completing the continuing education requirements during the initial biennial renewal period in which the license is issued.

 (c) The Board may waive all or a portion of the requirements of continuing education in cases of serious illness, undue hardship or military service. It shall be the duty of each licensee who seeks a waiver to notify the Board in writing and request the waiver prior to the end of the renewal period. The request must be made in writing, with appropriate documentation, and include a description of circumstances sufficient to show why the licensee is unable to comply with the continuing education requirement. The Board will grant, deny or grant in part the request for waiver and will send the licensee written notification of its approval or denial of the waiver request. A licensee who requests a waiver may not practice as a respiratory therapist after the expiration of the licensee's current license until the Board grants the waiver request.

 (d) A licensee shall maintain the information and documentation concerning compliance with the continuing education requirement or the waiver granted for a period of at least 2 years after the end of the biennial renewal period to which the continuing education or waiver applies, the date of completion of the continuing education or grant of the waiver, whichever is latest, and provide the information and documentation to representatives of the Board upon request.

§ 25.509b. Approved educational programs.

 (a) The Board approves respiratory care continuing education programs designated for professional development credits by the AARC, the AMA, the AOA and the CSRT.

 (1) Qualifying AMA continuing education programs must be in AMA PRA Category I credits, as defined in § 25.1 (relating to definitions).

 (2) Qualifying AOA continuing education programs must be in Category I-A or I-B credits, as defined in § 25.1.

 (b) Advanced course work in respiratory care successfully completed at a degree-granting institution of higher education approved by the United States Department of Education which offers academic credits are also approved for continuing education credit by the Board. Advanced course work is course work beyond the academic requirements necessary for licensure as a respiratory therapist.

 (c) The Board will not accept courses of study which do not relate to the actual provision of respiratory care. Examples of unacceptable courses are those in office management or practice building.

§ 25.510. Inactive status.

 (a) A licensee who does not intend to practice in this Commonwealth and who does not desire to renew licensure shall inform the Board in writing. Written confirmation of inactive status will be forwarded to the licensee.

 (b) A licensee shall notify the Board, in writing, of the licensee's desire to reactivate the license.

 (c) A licensee who is applying to return to active status is required to pay fees which are due for the current biennium and submit a sworn statement stating the period of time during which the licensee was not engaged in practice in this Commonwealth.

 (d) The applicant for reactivation will not be assessed a fee or penalty for preceding biennal periods in which the applicant did not engage in practice in this Commonwealth.

[Pa.B. Doc. No. 14-235. Filed for public inspection January 31, 2014, 9:00 a.m.]



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