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Pennsylvania Code



CHAPTER 18. STATE BOARD OF MEDICINE—PRACTITIONERS OTHER THAN MEDICAL DOCTORS

Subchap. Sec.

A.    LICENSURE AND REGULATION OF MIDWIFE ACTIVITIES … 18.1
B.    REGISTRATION AND PRACTICE OF ACUPUNCTURISTS AND PRACTITIONERS OF ORIENTAL MEDICINE … 18.11
C.    [Reserved] … 18.21
D.    PHYSICIAN ASSISTANTS … 18.121
E.    PERFORMANCE OF RADIOLOGIC PROCEDURES BY AUXILIARY PERSONNEL … 18.201
F.    RESPIRATORY THERAPISTS … 18.301
G.    MEDICAL DOCTOR DELEGATION OF MEDICAL SERVICES … 18.401
H.    ATHLETIC TRAINERS … 18.501
I.    BEHAVIOR SPECIALISTS … 18.521
J.    PERFUSIONISTS …18.601
K.    GENETIC COUNSELORS…18.701
L.    PROSTHETISTS, ORTHOTISTS, PEDORTHISTS AND ORTHOTIC FITTERS…18.801
M.    REGISTRATION OF NATUROPATHIC DOCTORS…18.901

Authority

   The provisions of this Chapter 18 issued under sections 6(a) and (d), 8 and 51 of the Medical Practice Act of 1985 (63 P.S. § §  422.6(a) and (d), 422.8 and 422.1 note); section 812.1 of The Administrative Code of 1929 (71 P.S. §  279.3a); and section 3(b) of the Acupuncture Registration Act (63 P.S. §  1803(b)), unless otherwise noted.

Source

   The provisions of this Chapter 18 adopted January 2, 1987, effective immediately and applies retroactively to December 31, 1986, 17 Pa.B. 24, unless otherwise noted.

Cross References

   This chapter cited in 6 Pa. Code §  22.62 (relating to conditions of provider participation); 6 Pa. Code §  22.82 (relating to false or fraudulent claims by providers); 25 Pa. Code §  215.24 (relating to human use); 28 Pa. Code §  107.12a (relating to specified professional personnel—statement of policy); 28 Pa. Code §  501.4 (relating to regulations); 28 Pa. Code §  601.3 (relating to requirements for home health care agencies); 49 Pa. Code §  16.1 (relating to definitions); 49 Pa. Code §  16.2 (relating to rules governing Board activities and proceedings); 49 Pa. Code §  16.12 (relating to general qualifications for licenses and certificates); 49 Pa. Code §  16.55 (relating to complaint process); 49 Pa. Code §  16.61 (relating to unprofessional and immoral conduct); 49 Pa. Code §  16.62 (relating to complaint process); 49 Pa. Code §  17.8 (relating to licenses, certificates and registrations issued prior to January 1, 1986); and 49 Pa. Code §  25.504 (relating to certification of respiratory care practitioners; practice; exceptions).

Subchapter A. LICENSURE AND REGULATION OF MIDWIFE ACTIVITIES


Sec.


18.1.    Definitions.
18.2.    Licensure requirements.
18.3.    Biennial registration requirements.
18.4.    Midwife protocol.
18.5.    Collaborative agreements.
18.6.    Practice of midwifery.
18.6a.    Prescribing, dispensing and administering drugs.
18.7.    Disciplinary and corrective measures.
18.8.    [Reserved].
18.9.    Notification of changes in collaboration.

Cross References

   This subchapter cited in 49 Pa. Code §  107.12a (relating to specified professional personnel—statement of policy).

§ 18.1. Definitions.

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

   ACME—The American Commission for Midwifery Education.

   ACNM—The American College of Nurse-Midwives.

   AMCB—The American Midwifery Certification Board.

   Collaborating physician—A medical or osteopathic doctor who has entered into a collaborative agreement with a nurse-midwife.

   Collaborative agreement—A signed written agreement between a midwife and collaborating physician in which they agree to the details of the collaborative arrangement between them with respect to care of midwifery clients.

   Legend drug—A drug:

     (i)   Limited by the Federal Food, Drug and Cosmetic Act (21 U.S.C.A. § §  301—399) to being dispensed by prescription.

     (ii)   The product label of which is required to contain the following statement: ‘‘Rx only.’’

   Midwife examination—An examination offered or recognized by the Board to test whether an individual has accumulated sufficient academic knowledge with respect to the practice of midwifery to qualify for a nurse-midwife license. The Board recognizes as midwife examinations the certifying examinations of the ACNM, the ACNM Certification Council, Inc. (ACC), and AMCB, or their successor organizations.

   Midwifery practice—Management of the care of essentially normal women and their normal neonates. This includes antepartum, intrapartum, postpartum and nonsurgically related gynecological care.

   Midwife program—An academic and clinical program of study in midwifery which has been approved by the Board or by an accrediting body recognized by the Board. The Board recognizes the ACNM and ACME or their successor organization as an accrediting body of programs of study in midwifery.

   Midwife practice guidelines—A written document developed by the nurse-midwife setting forth, in detail, the scope and limitations of the nurse-midwife’s intended practice.

   Neonate—An infant during the first 28 days following birth.

   Nurse-midwife—A person licensed by the Board to practice midwifery.

Authority

   The provisions of this §  18.1 amended under section 2 of the act of April 4, 1929 (P.L. 160, No. 155) (63 P.S. §  172); and sections 8, 12 and 35(a) of the Medical Practice Act of 1985 (63 P.S. § §  422.8, 422.12 and 422.35(a)).

Source

   The provisions of this §  18.1 adopted January 2, 1987, effective immediately and applies retroactively to December 31, 1986, 17 Pa.B. 24; amended May 19, 1989, effective May 20, 1989, 19 Pa.B. 2161; amended April 3, 2009, effective April 4, 2009, 39 Pa.B. 1625. Immediately preceding text appears at serial page (328702).

Cross References

   This section cited in 49 Pa. Code §  18.6 (relating to practice of midwifery).

§ 18.2. Licensure requirements.

 The Board will grant a nurse-midwife license to an applicant who meets the following requirements. The applicant shall:

   (1)  Be licensed as a registered nurse in this Commonwealth.

   (2)  Satisfy the licensure requirements in §  16.12 (relating to general qualifications for licenses and certificates), including the completion of at least 3 hours of approved training in child abuse recognition and reporting in accordance with §  16.108(a) (relating to child abuse recognition and reporting—mandatory training requirement).

   (3)  Have successfully completed a midwife program.

   (4)  Have obtained one of the following:

     (i)   A passing grade on a midwife examination. The Board accepts the passing grade on the certifying examination of the ACNM or AMCB as determined by the ACNM or AMCB or successor organization as recognized by the Board.

     (ii)   Certification as a midwife by the American College of Nurse-Midwives (ACNM) before the ACNM certification examination was first administered in 1971. To be eligible for renewal of a nurse-midwife license, the nurse-midwife shall maintain National certification available to the profession and recognized by the Board.

   (5)  Submit an application for a nurse-midwife license accompanied by the required fee. For the fee amount, see §  16.13 (relating to licensure, certification, examination and registration fees).

Authority

   The provisions of this §  18.2 amended under section 2 of the act of April 4, 1929 (P. L. 160, No. 155) (63 P.S. §  172); sections 8, 12 and 35(a) of the Medical Practice Act of 1985 (63 P.S. § §  422.8, 422.12 and 422.35(a)); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.2 adopted January 2, 1987, effective immediately and applies retroactively to December 31, 1986, 17 Pa.B. 24; amended May 19, 1989, effective May 20, 1989, 19 Pa.B. 2161; amended April 3, 2009, effective April 4, 2009, 39 Pa.B. 1625; amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial page (342659).

§ 18.3. Biennial registration requirements.

 (a)  A nurse-midwife license shall be registered biennially. The procedure for the biennial registration of a nurse-midwife license is in §  16.15 (relating to biennial registration; inactive status and unregistered status).

 (b)  As a condition of biennial license renewal, a nurse-midwife shall complete the continuing education requirement in section 12.1 of the Professional Nursing Law (63 P.S. §  222), including at least 2 hours of approved continuing education in child abuse recognition and reporting in accordance with §  16.108(b) (relating to child abuse recognition and reporting—mandatory training requirement). In the case of a nurse-midwife who has prescriptive authority under the act, the continuing education required by the Professional Nursing Law (63 P.S. § §  211—225.5) must include at least 16 hours in pharmacology completed each biennium.

 (c)  The fees for the biennial renewal of a nurse-midwife license and prescriptive authority are set forth in §  16.13 (relating to licensure, certification, examination and registration fees).

Authority

   The provisions of this §  18.3 amended under section 2 of the act of April 4, 1929 (P. L. 160, No. 155) (63 P.S. §  172); sections 8, 12 and 35(a) of the Medical Practice Act of 1985 (63 P.S. § §  422.8, 422.12 and 422.35(a)); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.3 adopted January 2, 1987, effective immediately and applies retroactively to December 31, 1986, 17 Pa.B. 24; amended May 19, 1989, effective May 20, 1989, 19 Pa.B. 2161; amended April 3, 2009, effective April 4, 2009, 39 Pa.B. 1625; amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial pages (342659) to (342660).

§ 18.4. Midwife practice guidelines.

 At a minimum, the midwife practice guidelines must identify the following:

   (1)  The procedures and routines of care, including specific treatment regimens to be provided by the midwife, by practice area—for example, antepartum, intrapartum, postpartum and nonsurgically related gynecological care.

   (2)  The circumstances under which consultation, co-management, referral and transfer of care of women and neonates are to take place, and the mechanics by which each are to occur.

   (3)  Procedures and routines of care of neonates, including specific treatment regimens, if the nurse-midwife manages the care of neonates beyond the time of delivery.

Authority

   The provisions of this §  18.4 amended under section 2 of the act of April 4, 1929 (P. L. 160, No. 155) (63 P.S. §  172); and sections 8, 12 and 35(a) of the Medical Practice Act of 1985 (63 P.S. § §  422.8, 422.12 and 422.35(a)).

Source

   The provisions of this §  18.4 adopted January 2, 1987, effective immediately and applies retroactively to December 31, 1986, 17 Pa.B. 24; amended May 19, 1989, effective May 20, 1989, 19 Pa.B. 2161; amended April 3, 2009, effective April 4, 2009, 39 Pa.B. 1625. Immediately preceding text appears at serial pages (222901) to (222902).

§ 18.5. Collaborative agreements.

 (a)  A nurse-midwife may not engage in midwifery practice without having entered into a collaborative agreement and having filed the collaborative agreement with the Board.

 (b)  A nurse-midwife shall only engage in midwifery practice in accordance with the midwife practice guidelines and collaborative agreements.

 (c)  A collaborative agreement must contain either an acknowledgement that the nurse-midwife shall practice under the midwife practice guidelines, or that the nurse-midwife shall practice under the midwife practice guidelines as expanded or modified in the collaborative agreement.

 (d)  Expansions and modifications of the midwife practice guidelines agreed to by the nurse-midwife and the collaborating physician shall be set forth, in detail, in the collaborative agreement.

 (e)  If the collaborating physician intends to authorize the nurse-midwife to relay to other health care providers medical regimens prescribed by that physician, including drug regimens, that authority, as well as the prescribed regimens, shall be set forth in the collaborative agreement.

 (f)  The physician with whom a nurse-midwife has a collaborative agreement shall have hospital privileges or a formal arrangement for patient admission to a hospital and shall practice in the specialty area of the care for which the physician is providing collaborative services.

 (g)  Collaborative agreements must meet the following requirements:

   (1)  The agreement must provide a predetermined plan for emergency services, and immediate availability of a physician to the nurse-midwife by direct communication or by radio, telephone or other telecommunication for consultation, co-management, or transfer of care as indicated by the health status of the patient.

   (2)  The agreement must identify and be signed by at least one collaborating physician and the nurse-midwife.

   (3)  A physician providing coverage need not be signatory to the collaborative agreement, but shall agree to adhere to the terms of the collaborative agreement, and shall be identified by name of physician, or name of group, or name of service.

   (4)  A physician providing interim coverage need not be signatory to the collaborative agreement, but shall agree to adhere to the terms of the collaborative agreement.

   (5)  Both the collaborating physician and the nurse-midwife are responsible to assure adherence to the terms and conditions of the collaborative agreement by themselves, others as appropriate within their practice groups, and physicians providing coverage.

 (h)  The collaborative agreement must satisfy the substantive requirements set forth in subsections (a)—(e) and be consistent with relevant provisions of the act and this subchapter, and must be filed with the Board. For a nurse-midwife with prescriptive authority, the collaborative agreement with a physician must identify the categories of drugs from which the nurse-midwife may prescribe or dispense and any restrictions thereto.

 (i)  A nurse-midwife or collaborating physician shall provide immediate access to the collaborative agreement to any client, pharmacist, licensed health care facility, licensed health care provider, physician, or the Board seeking to confirm the scope of the nurse-midwife’s authority, and the nurse-midwife’s ability to prescribe or dispense a drug.

Authority

   The provisions of this §  18.5 amended under section 2 of the act of April 4, 1929 (P. L. 160, No. 155) (63 P. S. §  172); and sections 8, 12 and 35(a) of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.12 and 422.35(a)).

Source

   The provisions of this §  18.5 adopted January 2, 1987, effective immediately and applies retroactively to December 31, 1986, 17 Pa.B. 24; amended May 19, 1989, effective May 20, 1989, 19 Pa.B. 2161; amended April 3, 2009, effective April 4, 2009, 39 Pa.B. 1625. Immediately preceding text appears at serial page (222902).

§ 18.6. Practice of midwifery.

 The nurse-midwife is authorized or required, or both, to do the following:

   (1)  Engage in midwifery practice as defined in §  18.1 (relating to definitions), as further provided for in this subchapter and in accordance with the ethical and quality standards of the profession as required in section 41(8) of the act (63 P. S. §  422.41(8)).

   (2)  Maintain a midwife protocol and collaborative agreements, and make them available for inspection by clients and the Board upon request.

   (3)  Prescribe medical, therapeutic and diagnostic measures for essentially normal women and their normal neonates in accordance with the midwife protocol or a collaborative agreement, or both.

   (4)  Administer specified drugs as provided in collaborative agreements or as directed by a collaborating physician for a specific patient and, if specifically authorized to do so in a collaborative agreement, relay to other health care providers medical regimens prescribed by the collaborating physician, including drug regimens.

   (5)  A nurse-midwife may, in accordance with a collaborative agreement with a physician, and consistent with the nurse-midwife’s academic educational preparation and National certification by the AMCB or its successor organizations, prescribe, dispense, order and administer medical devices, immunizing agents, laboratory tests and therapeutic, diagnostic and preventative measures.

   (6)  A nurse-midwife who possesses a master’s degree or its substantial equivalent, and National certification, and applies to the Board, is eligible to receive a certificate from the Board which will authorize the nurse-midwife to prescribe, dispense, order, and administer drugs, including legend drugs and Schedule II through Schedule V controlled substances, as defined in The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § §  780-101—780-144), in accordance with §  18.6a (relating to prescribing and dispensing drugs) provided that the nurse-midwife demonstrates to the Board that:

     (i)   The nurse-midwife has successfully completed at least 45 hours of course-work specific to advanced pharmacology at a level above that required by a professional nursing education program.

     (ii)   The nurse-midwife has successfully completed 16 hours of advanced pharmacology within 2 years immediately preceding the application for prescriptive authority.

     (iii)   The nurse-midwife is acting in accordance with the terms and conditions set forth in a collaborative agreement with a physician.

   (7)  Perform medical services in the care of women and neonates that may go beyond the scope of midwifery, if the authority to perform those services is delegated by the collaborating physician in the collaborative agreement, and the delegation is consistent with standards of practice embraced by the nurse-midwife and the relevant physician communities in this Commonwealth, as set forth in § §  18.401—18.402 (relating to medical doctor delegation of medical services).

   (8)  Refer and transfer to the care of a physician, as provided for in the midwife practice guidelines or a collaborative agreement, or both, those women and neonates whose medical problems are outside the scope of midwifery practice and who require medical services which have not been delegated to the nurse-midwife in a collaborative agreement.

   (9)  Review and revise the midwife practice guidelines as needed.

   (10)  Carry out responsibilities placed by law or regulation upon a person performing the functions that are performed by a nurse-midwife.

Authority

   The provisions of this §  18.6 amended under section 2 of the act of April 4, 1929 (P. L. 160, No. 155) (63 P. S. §  172); and sections 8, 12 and 35(a) of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.12 and 422.35(a)).

Source

   The provisions of this §  18.6 adopted January 2, 1987, effective immediately and applies retroactively to December 31, 1986, 17 Pa.B. 24; amended May 19, 1989, effective May 20, 1989, 19 Pa.B. 2161; amended April 3, 2009, effective April 10, 2009, 39 Pa.B. 1625. Immediately preceding text appears at serial page (326815).

§ 18.6a. Prescribing, dispensing and administering drugs.

 (a)  No Schedule I controlled substances. A nurse-midwife may not prescribe or dispense Schedule I controlled substances as defined by section 4 of The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §  780-104).

 (b)  Prescribing, dispensing and administering drugs. A nurse-midwife who has prescriptive authority may prescribe, administer and dispense drugs as follows:

   (1)  A nurse-midwife may prescribe, dispense or administer Schedule II through V controlled substances and legend drugs in accordance with the following restrictions:

     (i)   A nurse-midwife may not prescribe, dispense, order or administer a controlled substance except for a woman’s acute pain.

     (ii)   In the case of a Schedule II controlled substance, the dose must be limited to 72 hours and may not be extended except with the approval of the collaborating physician.

     (iii)   In the case of a Schedule III or IV controlled substance, the prescription must be limited to 30 days and shall only be refilled with the approval of the collaborating physician.

     (iv)   A nurse-midwife may prescribe, dispense, order or administer psychotropic drugs only after consulting with the collaborating physician.

     (v)   A nurse-midwife may only prescribe or dispense a drug for a patient in accordance with the collaborative agreement.

     (vi)   A nurse-midwife may not delegate prescriptive authority to another health care provider.

   (2)  A nurse-midwife authorized to prescribe or dispense, or both, controlled substances, shall register with the United States Drug Enforcement Administration.

 (c)  Prescription blanks. The requirements for prescription blanks are as follows:

   (1)  Prescription blanks must bear the license number of the nurse-midwife and the name and contact information, including phone number, of the nurse-midwife in a printed format at the heading of the blank, as well as the initials ‘‘C.N.M.’’ or similar designation.

   (2)  The signature of the nurse-midwife must be followed by the initials ‘‘C.N.M.’’ or similar designation to identify the signer as a nurse-midwife.

   (3)  A nurse-midwife may use a prescription blank generated by a hospital or other licensed healthcare facility, provided the information in paragraph (1) appears on the blank.

   (4)  Prescription blanks may not be presigned by the nurse-midwife or collaborating physician.

 (d)  Inappropriate prescribing. Any party who identifies an inappropriate prescription shall immediately advise the nurse-midwife or the collaborating physician. The nurse-midwife or collaborating physician shall advise the patient to modify or discontinue use of the drug as medically appropriate. In the case of a written prescription, the nurse-midwife or the collaborating physician shall notify the pharmacy of the changes to the prescription. The order to modify or discontinue the use of the drug or prescription must be noted in the patient’s medical record. The nurse-midwife shall seek consultation as medically indicated.

 (e)  Recordkeeping requirements. Recordkeeping requirements are as follows:

   (1)  When prescribing a drug, the nurse-midwife shall record in the patient’s medical record the name, amount, directions for use and doses of the drug prescribed, the number of refills, the date of the prescription and the nurse-midwife’s name. When utilizing electronic prescribing, the nurse-midwife shall comply with the requirements of the State Board of Pharmacy in §  27.201 (relating to electronically transmitted prescriptions).

   (2)  When dispensing a drug, the nurse-midwife shall record in the patient’s medical record the name, amount, directions for use and doses of the medication dispensed, the date dispensed, and the nurse-midwife’s name.

 (f)  Compliance with regulations relating to prescribing, administering, dispensing, packaging and labeling of drugs. A nurse-midwife shall comply with § §  16.92—16.94 (relating to prescribing, administering and dispensing controlled substances; packaging; and labeling of dispensed drugs) and Department of Health regulations in 28 Pa. Code § §  25.51—25.58 (relating to prescriptions) and regulations regarding packaging and labeling dispensed drugs. See §  16.94 and 28 Pa. Code § §  25.91—25.95 (relating to labeling of drugs, devices and cosmetics).

Authority

   The provisions of these sections 12 and 35 of the Medical Practice Act of 1985 (63 P. S. § §  422.12 and 422.35), unless otherwise noted.

Source

   The provisions of this §  18.6a adopted April 3, 2009, effective April 4, 2009, 39 Pa.B. 1625.

§ 18.7. Disciplinary and corrective measures.

 (a)  The Board may refuse, revoke, suspend, limit or attach conditions to the license of a nurse-midwife engaging in conduct prohibited by section 41(8) of the act (63 P. S. §  422.41(8)) for Board-regulated practitioners.

 (b)  The Board will order the emergency suspension of the license of a nurse-midwife who presents an immediate and clear danger for the public health and safety, as required by section 40 of the act (63 P. S. §  422.40).

 (c)  The license of a nurse-midwife shall automatically be suspended, as required by section 40 of the act.

Authority

   The provisions of this §  18.7 amended under section 2 of the act of April 4, 1929 (P. L. 160, No. 155) (63 P. S. §  172); and sections 8, 12 and 35(a) of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.12 and 422.35(a)).

Source

   The provisions of this §  18.7 adopted January 2, 1987, effective immediately and applies retroactively to December 31, 1986, 17 Pa.B. 24; amended May 19, 1989, effective May 20, 1989, 19 Pa.B. 2161; amended April 3, 2009, effective April 4, 2009, 39 Pa.B. 1625. Immediately preceding text appears at serial page (326816).

§ 18.8. [Reserved].


Source

   The provisions of this §  18.8 adopted January 2, 1987, effective immediately and applies retroactively to December 31, 1986, 17 Pa.B. 24; reserved May 19, 1989, effective May 20, 1989, 19 Pa.B. 2161. Immediately preceding text appears at serial page (114029).

§ 18.9. Notification of changes in collaboration.

 (a)  A nurse-midwife licensed to practice midwifery who is unable to maintain a collaborative agreement and cannot arrange interim coverage shall cease practicing until a collaborative agreement is in place.

 (b)  A nurse-midwife shall notify the Board, in writing, of a change in or termination of a collaborative agreement or a change in mailing address within 30 days. The nurse-midwife shall provide the Board with the nurse-midwife’s new address of residence, address of employment and any change of collaborating physician. A change in medical staff of a medical practice identified in the collaborative agreement is not a change in the collaborating agreement, so long as the named collaborating physician continues to collaborate with the nurse-midwife under the collaborative agreement.

 (c)  Failure of a nurse-midwife to notify the Board within 30 days of changes in, or a termination in the collaborating physician/nurse-midwife relationship is a basis for disciplinary action against the nurse-midwife’s license.

 (d)  A nurse-midwife with prescriptive authority who cannot continue to fulfill the requirements for prescriptive authority shall cease to prescribe and shall so notify the Board in writing within 30 days.

Authority

   The provisions of this §  18.9 adopted under sections 12 and 35 of the Medical Practice Act of 1985 (63 P. S. § §  422.12 and 422.35).

Source

   The provisions of this §  18.9 adopted April 3, 2009, effective April 4, 2009, 39 Pa.B. 1625.

Subchapter B. LICENSURE AND PRACTICE OF ACUPUNCTURISTS AND PRACTITIONERS OF ORIENTAL MEDICINE


 (Editor’s Note: The final-form rulemaking published at 54 Pa.B 2780 (May 18, 2024) overlooked the amendment of the Subchapter B heading published at 53 Pa.B. 5759 (September 16, 2023).)

Sec.


18.11.    Definitions.
18.12.    Licensure as an acupuncturist.
18.13.    Requirements for licensure as an acupuncturist.
18.13a.    Requirements for licensure as a practitioner of Oriental medicine.
18.14.    Biennial registration requirements.
18.15.    Practice responsibilities of acupuncturist and practitioner of Oriental medicine who is not a physician; practice responsibilities of an acupuncturist who is licensed as a medical doctor.
18.15a.    Scope of practice of acupuncturists and practioners of Oriental medicine.
18.16.    [Reserved].
18.17.    [Reserved].
18.18.    Disciplinary and corrective measures.
18.19.    [Reserved].
18.20.    Professional liability insurance coverage for acupuncturists and practitioners of Oriental medicine.

§ 18.11. Definitions.

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

   Acupuncture

     (i)   The stimulation of certain points on or near the surface of the body by the insertion of needles to prevent or alleviate the perception of pain or to normalize physiological functions, including pain control, for the treatment of certain diseases or dysfunctions of the body.

     (ii)   The term also includes the use of supplemental techniques.

   Acupuncture educational program—Training and instruction in acupuncture or supplemental acupuncture techniques offered by a degree-granting institution authorized by the Department of Education that leads to a master’s degree, master’s level certificate or diploma or first professional degree, that meets the relevant and appropriate requirements of 22 Pa. Code (relating to education) and 24 Pa.C.S. Chapter 65 (relating to private colleges, universities and seminaries) and that meets or exceeds the standards required for acupuncture or Oriental medicine programs established by an accrediting agency recognized by the United States Department of Education.

   Acupuncture examination—An examination recognized by the Board to test whether an individual has accumulated sufficient academic knowledge with respect to the practice of acupuncture to qualify for the privilege of practicing as an acupuncturist in this Commonwealth.

   Acupuncture medical program—An academic or clinical program of study in acupuncture which has been given category I continuing medical education credit by an institution accredited or recognized by the Accreditation Council on Continuing Medical Education to conduct category I continuing medical education courses.

   Acupuncturist—An individual licensed to practice acupuncture by the Board.

   East Asian herbology—The use of herbal preparations and products that contain as active ingredients parts of plants, minerals and other organic materials, or a combination thereof, administered according to East Asian medicine tradition to normalize function.

   East Asian herbology examination—An examination recognized by the Board to test whether an acupuncturist has accumulated sufficient academic knowledge with respect to the practice of herbal therapy to qualify for licensure as a practitioner of Oriental medicine in this Commonwealth.

   Herbal therapy—The application of East Asian herbology to the treatment of acupuncture patients.

   NCCAOM—The National Certification Commission for Acupuncture and Oriental Medicine or its successor organization.

   OET—The English language test for healthcare professionals or its successor examination.

   Practitioner of Oriental medicine—An acupuncturist who is licensed by the Board to use herbal therapy.

   Supplemental techniques—The use of traditional and modern Oriental therapeutics, heat therapy, moxibustion, electrical and low-level laser stimulation, acupressure and other forms of massage, and counseling that includes the therapeutic use of foods and supplements and lifestyle modifications.

   TOEFL®—The Test of English as a Foreign Language offered by Educational Testing Service (ETS).

Authority

   The provisions of this §  18.11 amended under section 3 of the Acupuncture Licensure Act (63 P.S. §  1803); and section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8).

Source

   The provisions of this §  18.11 adopted January 2, 1987, effective immediately and applies retroactively to December 31, 1986, 17 Pa.B. 24; amended May 19, 1989, effective May 20, 1989, 19 Pa.B. 2161; amended April 13, 2007, effective April 14, 2007, 37 Pa.B. 1644; amended January 8, 2010, effective January 9, 2010, 40 Pa.B. 250; amended September 15, 2023, effective September 16, 2023, 53 Pa.B. 5759. Immediately preceding text appears at serial pages (347371) to (347372).

Cross References

   This section cited in 49 Pa. Code §  5.81 (relating to unprofessional and immoral conduct); and 49 Pa. Code §  18.15a (relating to scope of practice of acupuncturists and practitioners of Oriental medicine).

§ 18.12. Licensure as an acupuncturist.

 A medical doctor who intends to practice acupuncture and any other individual who intends to practice acupuncture shall obtain a license from the Board as an acupuncturist.

Authority

   The provisions of this §  18.12 amended under section 3 of the Acupuncture Licensure Act (63 P.S. §  1803); and section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8).

Source

   The provisions of this §  18.12 amended April 13, 2007, effective April 14, 2007, 37 Pa.B. 1644; amended January 8, 2010, effective January 9, 2010, 40 Pa.B. 250. Immediately preceding text appears at serial page (342668).

Cross References

   This section cited in 49 Pa. Code §  5.81 (relating to unprofessional and immoral conduct).

§ 18.13. Requirements for licensure as an acupuncturist.

 (a)  The Board will license as an acupuncturist a person who satisfies the following requirements:

   (1)  Has successfully completed an acupuncture educational program which includes a course in needle sterilization techniques.

   (2)  Has been certified by NCCAOM or has obtained a passing grade on the NCCAOM examination component in acupuncture and sterilization procedures, its successor examination or other equivalent Board-approved examination. The Board will make available a list of successor or other equivalent Board-approved examinations on its web site. If the examination was not taken in English, but is otherwise acceptable and a passing score was secured, the Board will accept the examination result if the applicant has also demonstrated English language proficiency by one of the following methods:

     (i)   The applicant’s acupuncture educational program was conducted in English.

     (ii)   The applicant has achieved a scaled score of at least 83 on the TOEFL® Internet-based test (IBT), a 220 for the TOEFL® computer-based test (CBT) or a 550 on the TOEFL® paper based test (PBT) or an equivalent score on a successor examination of the TOEFL®. The Board will make available a list of Board-approved successor examinations on its web site.

     (iii)   The applicant has achieved a score of at least 350 on each of the four sub-tests of the OET for any of the health-related professions.

     (iv)   The applicant has achieved a passing score on an English language proficiency examination, equivalent to the TOEFL® or OET, as determined by the Board. The Board will make available a list of equivalent Board-approved English language proficiency examinations on its web site.

 (b)  The Board will license as an acupuncturist a medical doctor who satisfies the following requirements:

   (1)  Has successfully completed 200 hours of training in acupuncture medical programs including examinations required by those programs.

   (2)  Submits an application to register as an acupuncturist accompanied by the required fee as provided under §  16.13 (relating to licensure, certification, examination and registration fees).

 (c)  [Reserved].

Authority

   The provisions of this §  18.13 amended under section 3 of the Acupuncture Licensure Act (63 P.S. §  1803); section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.13 adopted January 2, 1987, effective immediately and applies retroactively to December 31, 1986, 17 Pa.B. 24; amended May 19, 1989, effective May 20, 1989, 19 Pa.B. 2161; amended April 13, 2007, effective April 14, 2007, 37 Pa.B. 1644; amended January 8, 2010, effective January 9, 2010, 40 Pa.B. 250; amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899; amended September 15, 2023, effective September 16, 2023, 53 Pa.B. 5759. Immediately preceding text appears at serial page (409189).

Cross References

   This section cited in 49 Pa. Code §  5.81 (relating to unprofessional and immoral conduct); and 49 Pa. Code §  18.13a (relating to requirements for licensure as a practitioner of Oriental medicine).

§ 18.13a. Requirements for licensure as a practitioner of Oriental medicine.

 (a)  An acupuncturist who also intends to use herbal therapy is required to be licensed by the Board as a practitioner of Oriental medicine.

 (b)  The Board will license an acupuncturist as a practitioner of Oriental medicine if the licensee, in addition to meeting the requirements under §  18.13 (relating to requirements for licensure as an acupuncturist) has fulfilled one of the following:

   (1)  Successfully completed an acupuncture education program that includes the study of East Asian herbology and has passed an East Asian herbology examination. Board-approved East Asian herbology examinations include the NCCAOM examination component in Chinese herbology, its successor examination or other equivalent Board-approved East Asian herbology examination. The Board will make available a list of successor or other equivalent Board-approved examinations on its web site.

   (2)  Has obtained NCCAOM certification in Chinese herbology or Oriental medicine, which includes passing the NCCAOM examination component in Chinese herbology.

 (c)  An acupuncturist registered with the Board prior to April 14, 2007, may obtain a license as a practitioner of Oriental medicine if the acupuncturist can demonstrate one of the following:

   (1)  Successful completion of an East Asian herbology or Oriental medicine education program recognized by the licensing authority of another state or United States territory for the practice of herbal therapy or Oriental medicine and successful completion of an examination in East Asian herbology or Oriental medicine recognized by the licensing authority of another state or United States territory for the practice of herbal therapy or Oriental medicine.

   (2)  NCCAOM certification in Chinese herbology or Oriental medicine.

   (3)  The achievement of cumulative qualifications that the Board determines to be equivalent to the standard requirements for registration as a practitioner of Oriental medicine.

 (d)  This section does not apply to a medical doctor licensed as an acupuncturist nor does it restrict the practice of medicine by a medical doctor.

 (e)  This section does not limit a registered naturopathic doctor who is also licensed as an acupuncturist when recommending herbs, minerals and other supplements, or combinations, according to traditions other than Oriental medicine traditions.

Authority

   The provisions of this §  18.13a amended under section 3 of the Acupuncture Licensure Act (63 P.S. §  1803); section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8); and sections 202(6), 203(b) and (c) and 207 of the Naturopathic Doctor Registration Act (63 P.S. § §  272.202(6), 272.203(b) and (c) and 272.207).

Source

   The provisions of this §  18.13a adopted April 13, 2007, effective April 14, 2007, 37 Pa.B. 1644; amended January 8, 2010, effective January 9, 2010, 40 Pa.B. 250; amended September 15, 2023, effective September 16, 2023, 53 Pa.B. 5759; amended May 17, 2024, effective May 18, 2024, 54 Pa.B. 2780. Immediately preceding text appears at serial pages (415580) to (415581).

Cross References

   This section cited in 49 Pa. Code §  5.81 (relating to unprofessional and immoral conduct).

§ 18.14. Biennial registration requirements.

 (a)  Acupuncturists and practitioners of Oriental medicine shall register biennially and submit the appropriate registration fee to engage in the practice of acupuncture for the biennial period.

 (b)  Procedures for biennial registration of acupuncturists and practitioners of Oriental medicine are outlined in §  16.15 (relating to biennial registration; inactive status and unregistered status).

 (c)  The biennial registration fee is set forth in §  16.13 (relating to licensure, certification, examination and registration fees).

 (d)  As a condition of biennial registration, acupuncturists and practitioners of Oriental medicine shall complete at least 2 hours of approved training in child abuse recognition and reporting in accordance with §  16.108(b) (relating to child abuse recognition and reporting—mandatory training requirement).

Authority

   The provisions of this §  18.14 amended under section 3 of the Acupuncture Licensure Act (63 P.S. §  1803); section 8 of the Medical Practices Act of 1985 (63 P.S. §  422.8); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.14 amended April 13, 2007, effective April 14, 2007, 37 Pa.B. 1644; amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial page (347375).

Cross References

   This section cited in 49 Pa. Code §  5.81 (relating to unprofessional and immoral conduct).

§ 18.15. Practice responsibilities of acupuncturist and practitioner of Oriental medicine who is not a physician; practice responsibilities of an acupuncturist who is licensed as a medical doctor.

 (a)  Responsibilities to patient and public—acupuncturist who is not a physician. An acupuncturist who is not a physician:

   (1)  Shall perform an acupuncture evaluation and develop an acupuncture treatment plan.

   (1.1)  May treat an individual presenting with no symptoms of a condition for an unlimited period of time.

   (2)  May treat an individual presenting with symptoms of a condition for 60 calendar days from the date of the first treatment without the condition being diagnosed by a physician, dentist or podiatrist.

   (3)  May treat an individual presenting with symptoms of a condition beyond 60 calendar days from the date of first treatment if the patient has obtained an examination and diagnosis from a physician, dentist or podiatrist.

   (4)  Shall promptly refer the patient presenting with symptoms of a condition to a physician, dentist or podiatrist, as appropriate to the patient’s condition, if the acupuncturist determines that further acupuncture treatment is contraindicated for the patient or determines that the patient’s symptoms have worsened.

   (5)  Shall consult with the patient’s physician, dentist, podiatrist or other health care practitioner upon request of the patient.

   (6)  Shall cooperate with the patient’s physician, dentist or podiatrist in regard to the coordination of the patient’s care, and comply with restrictions or conditions as directed by the physician, dentist or podiatrist.

   (7)  May not diagnose a physical or mental ailment or condition or prescribe or dispense a drug. This provision does not prohibit the use of diagnostic billing codes for billing or reimbursement purposes.

   (8)  Shall comply strictly with sterilization standards relative to aseptic practices.

   (9)  Shall maintain patient records in a manner consistent with §  16.95 (relating to medical records).

   (10)  Shall wear a tag or badge with lettering clearly visible to the patient bearing the acupuncturist’s name and the title ‘‘acupuncturist.’’ The use of the words doctor, physician or any title or abbreviation implying licensure as a physician on this tag or badge is prohibited, provided, however, that an individual licensed as an acupuncturist who also possesses a current and active registration as a naturopathic doctor may utilize the title ‘‘doctor of naturopathic medicine’’ or ‘‘naturopathic doctor’’ in addition to the title ‘‘acupuncturist.’’

 (b)  [Reserved].

 (b.1)  Additional responsibilities to patient and public—practitioner of Oriental medicine who is not a physician. In addition to the responsibilities in subsection (a)(1)—(9), a licensed practitioner of Oriental medicine who provides, or contemplates providing, herbal therapy:

   (1)  Shall perform an herbal therapy evaluation and, if appropriate, develop an appropriate treatment plan utilizing, in whole or in part, East Asian herbology modalities.

   (2)  Shall promptly refer a patient presenting with symptoms of a condition to a physician, dentist or podiatrist, as appropriate to the patient’s condition, if the practitioner of Oriental medicine determines that further treatment of the patient by East Asian herbology modalities is contraindicated for the patient, may interfere with known drugs prescribed to the patient, or determines that the patient’s symptoms have worsened.

   (3)  Shall wear a tag or badge with lettering clearly visible to the patient bearing the licensee’s name, as well as the title ‘‘practitioner of Oriental medicine.’’ The use of the words doctor, physician or any title or abbreviation implying licensure as a physician on this tag or badge is prohibited, provided, however, that an individual licensed as a practitioner of Oriental medicine who also possesses a current and active registration as a naturopathic doctor may utilize the title ‘‘doctor of naturopathic medicine’’ or ‘‘naturopathic doctor’’ in addition to the title ‘‘practitioner of Oriental medicine.’’

 (c)  Responsibilities to patient and public—acupuncturist who is currently licensed as a medical doctor. An acupuncturist who also holds a current and active license as a medical doctor in this Commonwealth:

   (1)  Shall include in the patient’s medical records evidence of having performed an acupuncture evaluation and development of an acupuncture treatment plan for patients considered for, or who receive, acupuncture.

   (2)  Shall comply strictly with sterilization standards relative to aseptic practices when providing acupuncture to patients.

Authority

   The provisions of this §  18.15 amended under section 3(b) of the Accupuncture Licensure Act (63 P.S. §  1803(b)); sections 202(6), 203(b) and (c) and 207 of the Naturopathic Doctor Registration Act (63 P.S. § §  272.202(6), 272.203(b) and (c) and 272.207; and section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8).

Source

   The provisions of this §  18.15 amended January 8, 2010, effective January 9, 2010, 40 Pa.B. 250; amended September 15, 2023, effective September 16, 2023, 53 Pa.B. 5759; amended May 17, 2024, effective May 18, 2024, 54 Pa.B. 2780. Immediately preceding text appears at serial pages (415582) to (415583).

Cross References

   This section cited in 49 Pa. Code §  5.81 (relating to unprofessional and immoral conduct); and 49 Pa. Code §  18.18 (relating to disciplinary and corrective measures).

§ 18.15a. Scope of practice of acupuncturists and practitioners of Oriental medicine.

 (a)  An acupuncturist may practice acupuncture and use supplemental techniques, including the use of non-prescription topical remedies which contain as active ingredients parts of plants, minerals and other organic materials, but may not use herbal therapy as defined in §  18.11 (relating to definitions) unless licensed by the Board as a practitioner of Oriental medicine.

 (b)  A practitioner of Oriental medicine may practice acupuncture and use supplemental techniques including herbal therapy. A practitioner of Oriental medicine is not prohibited from dispensing or administering therapeutic herbs that contain ingredients that are similar or equivalent to active ingredients in drugs as classified by the Federal Food and Drug Administration, unless otherwise prohibited by law or regulation.

 (c)  This section does not limit the scope of practice of a medical doctor who is registered as an acupuncturist.

 (d)  This section does not limit a registered naturopathic doctor when recommending herbs, minerals and other supplements, or combinations, according to traditions other than Oriental medicine traditions.

Authority

   The provisions of this §  18.15a amended under section 3 of the Acupuncture Licensure Act (63 P.S. §  1803); section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8); and sections 202(6), 203(b) and (c) and 207 of the Naturopathic Doctor Registration Act (63 P.S. § §  272.202(6), 272.203(b) and (c) and 272.207).

Source

   The provisions of this §  18.15a adopted April 13, 2007, effective April 14, 2007, 37 Pa.B. 1644; amended January 8, 2010, effective January 9, 2010, 40 Pa.B. 250; amended September 15, 2023, effective September 16, 2023, 53 Pa.B. 5759; amended May 17, 2024, effective May 18, 2024, 54 Pa.B. 2780. Immediately preceding text appears at serial pages (415583) to (415584).

Cross References

   This section cited in 49 Pa. Code §  5.81 (relating to unprofessional and immoral conduct).

§ 18.16. [Reserved].


Source

   The provisions of this §  18.16 reserved April 13, 2007, effective April 14, 2007, 37 Pa.B. 1644. Immediately preceding text appears at serial pages (222908) to (222909).

§ 18.17. [Reserved].


Source

   The provisions of this §  18.17 reserved April 13, 2007, effective April 14, 2007, 37 Pa.B. 1644. Immediately preceding text appears at serial pages (222909) to (222910).

§ 18.18. Disciplinary and corrective measures.

 (a)  The Board may impose any of the disciplinary sanctions authorized under section 42 of the act (63 P.S. §  422.42) or 63 Pa.C.S. §  3108(b) (relating to civil penalties) for any of the following:

   (1)  Failing to comply with the duties and requirements in §  18.15 (relating to practice responsibilities of acupuncturist and practitioner of Oriental medicine who is not a physician; practice responsibilities of an acupuncturist who is licensed as a medical doctor).

   (2)  Practicing or holding out as being able to practice acupuncture without a current and valid license to practice acupuncture.

   (3)  Practicing or holding out as being able to practice East Asian herbology without a current and valid license as a practitioner of Oriental medicine.

   (4)  Practicing acupuncture or East Asian herbology without current professional liability insurance coverage as required under section 3.2 of the Acupuncture Licensure Act (63 P.S. §  1803.2) and §  18.20 (relating to professional liability insurance coverage for acupuncturists and practitioners of Oriental medicine).

   (5)  Engaging in conduct prohibited under section 41 of the act (63 P.S. §  422.41) for Board-regulated practitioners.

   (6)  Failure to notify the Board within 30 days of licensee’s failure to be covered by insurance under as required under section 3.2 of the Acupuncture Licensure Act and §  18.20.

 (b)  The Board will order the emergency suspension of the license of an acupuncturist or practitioner of Oriental medicine who presents an immediate and clear danger to the public health and safety, as required under section 40 of the act (63 P.S. §  422.40).

 (c)  The license of an acupuncturist or practitioner of Oriental medicine shall automatically be suspended, as required under section 40 of the act.

Authority

   The provisions of this §  18.18 amended under section 3 of the Acupuncture Licensure Act (63 P.S. §  1803); and section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8).

Source

   The provisions of this §  18.18 adopted January 2, 1987, effective immediately and applies retroactively to December 31, 1986, 17 Pa.B. 24; amended May 19, 1989, effective May 20, 1989, 19 Pa.B. 2161; amended April 13, 2007, effective April 14, 2007, 37 Pa.B. 1644; amended January 8, 2010, effective January 9, 2010, 40 Pa.B. 250; amended September 15, 2023, effective September 16, 2023, 53 Pa.B. 5759. Immediately preceding text appears at serial page (347377).

Cross References

   This section cited in 49 Pa. Code §  5.81 (relating to unprofessional and immoral conduct).

§ 18.19. [Reserved].


Source

   The provisions of this §  18.19 corrected January 9, 1987, effective immediately and applies retroactively to December 31, 1986, 17 Pa.B. 185; reserved April 13, 2007, effective April 14, 2007, 37 Pa.B. 1644. Immediately preceding text appears at serial page (222910).

§ 18.20. Professional liability insurance coverage for acupuncturists and practitioners of Oriental medicine.

 (a)  A licensed acupuncturist shall maintain a level of professional liability insurance coverage in the minimum amount of $1 million per occurrence or claims made, as required under section 3.2 of the Acupuncture Licensure Act (63 P.S. §  1803.2).

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

   (1)  A certificate of insurance or copy of the declaration page from a personally purchased professional liability insurance policy setting forth the effective date, expiration date and dollar amount of coverage.

   (2)  A certificate of insurance or copy of the declaration page from an employer purchased professional liability insurance policy describing the licensee by name as a covered party under the policy, the effective date, expiration date and dollar amount of coverage.

   (3)  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 licensee who does not have current professional liability insurance coverage as required under section 3.2 of the Acupuncture Licensure Act may not practice as an acupuncturist or as a practitioner of Oriental medicine in this Commonwealth.

 (d)  The professional liability insurance coverage for a licensed practitioner of Oriental medicine shall cover claims related to acupuncture as well as claims related to the provision of herbal therapy.

 (e)  The license of an acupuncturist or practitioner of Oriental medicine shall automatically be suspended upon failure to be covered by the required professional liability insurance required in this section and shall not be restored until submission to the Board of satisfactory evidence that the licensee has the required professional liability insurance coverage.

Source

   The provisions of this §  18.20 added September 15, 2023, effective September 16, 2023, 53 Pa.B. 5759.

Cross References

   This section cited in 49 Pa. Code §  18.18 (relating to disciplinary and corective measures).

Subchapter C. [Reserved]


Sec.


18.21.    [Reserved].
18.22.    [Reserved].
18.31.    [Reserved].
18.41.    [Reserved].
18.42.    [Reserved].
18.51.    [Reserved].
18.52.    [Reserved].
18.53.    [Reserved].
18.54.    [Reserved].
18.55.    [Reserved].
18.56.    [Reserved].
18.57.    [Reserved].
18.61.    [Reserved].
18.62.    [Reserved].
18.63.    [Reserved].
18.64.    [Reserved].
18.71.    [Reserved].
18.81.    [Reserved].
18.91.    [Reserved].
18.101.    [Reserved].
18.111.    [Reserved].

Authority

   The provisions of this Subchapter C reserved under section 8 of the Medical Practice Act of 1985 (63 P. S. §  422.8); and sections 2.1(k) and (l) and 8.1—8.3 of The Professional Nursing Law (63 P. S § §  212.1(k) and (l) and 218.1—218.3), unless otherwise noted.

Source

   The provisions of this Subchapter C reserved April 19, 2013, effective April 20, 2013, 43 Pa.B. 2145, unless otherwise noted. Immediately preceding text appears at serial pages (348882), (271689) to (271692), (272603) to (272604), (271695) to (271696) and (323415) to (323416).

Cross References

   This subchapter cited in 28 Pa. Code §  9.678 (relating to PCPs); 55 Pa. Code §  1153.41a (relating to medication prescription—statement of policy); 55 Pa. Code §  2380.122a (relating to labeling of medications—statement of policy); 55 Pa. Code §  2380.124a (relating to medication log—statement of policy); 55 Pa. Code §  2380.126a (relating to adverse reaction—statement of policy); 55 Pa. Code §  5200.42a (relating to medication prescription—statement of policy); 55 Pa. Code §  5210.58a (relating to medication prescription—statement of policy); 55 Pa. Code §  6400.162a (relating to labeling of medication—statement of policy); 55 Pa. Code §  6400.163a (relating to use of prescription medication—statement of policy); 55 Pa. Code §  6400.164a (relating to medication log—statement of policy); 55 Pa. Code §  6400.166a (relating to adverse reaction—statement of policy); 55 Pa. Code §  6500.132a (relating to labeling of medication—statement of policy); 55 Pa. Code §  6500.133a (relating to use of prescription medications—statement of policy); 55 Pa. Code §  6500.134a (relating to medication log—statement of policy); and 55 Pa. Code §  6500.136a (relating to adverse reaction—statement of policy).

§ 18.21. [Reserved].

§ 18.22. [Reserved].

§ 18.31. [Reserved].

§ 18.41. [Reserved].

§ 18.42. [Reserved].

§ 18.51. [Reserved].

§ 18.52. [Reserved].

§ 18.53. [Reserved].


Authority

   The provisions of this §  18.53 issued under section 15(b) of the Medical Practice Act of 1985 (63 P. S. §  422.15(b)); and section 2(1) of the Professional Nursing Law (63 P. S. §  212(1)); reserved under section 8 of the Medical Practice Act of 1985 (63 P. S. §  422.8); and sections 2.1(k) and (l) and 8.1—8.3 of The Professional Nursing Law (63 P. S. § §  212.1(k) and (l) and 218.1—218.3).

Source

   The provisions of this §  18.53 adopted November 17, 2000, effective November 18, 2000, 30 Pa.B. 5943; reserved April 19, 2013, effective April 20, 2013, 43 Pa.B. 2145. Immediately preceding text appears at serial pages (271690) to (271691).

§ 18.54. [Reserved].


Authority

   The provisions of this §  18.54 issued under section 15(b) of the Medical Practice Act of 1985 (63 P. S. §  422.15(b)); and section 2(1) of the Professional Nursing Law (63 P. S. §  212(1)); reserved under section 8 of the Medical Practice Act of 1985 (63 P. S. §  422.8); and sections 2.1(k) and (l) and 8.1—8.3 of The Professional Nursing Law (63 P. S. § §  212.1(k) and (l) and 218.1—218.3).

Source

   The provisions of this §  18.54 adopted November 17, 2000, effective November 18, 2000, 30 Pa.B. 5943; reserved April 19, 2013, effective April 20, 2013, 43 Pa.B. 2145. Immediately preceding text appears at serial pages (271691) to (271692) and (272603).

§ 18.55. [Reserved].


Authority

   The provisions of this §  18.55 issued under section 15(b) of the Medical Practice Act of 1985 (63 P. S. §  422.15(b)); and section 2(1) of the Professional Nursing Law (63 P. S. §  212(1)); reserved under section 8 of the Medical Practice Act of 1985 (63 P. S. §  422.8); and sections 2.1(k) and (l) and 8.1—8.3 of The Professional Nursing Law (63 P. S. § §  212.1(k) and (l) and 218.1—218.3).

Source

   The provisions of this §  18.55 adopted November 17, 2000, effective November 18, 2000, 30 Pa.B. 5943; corrected December 29, 2000, effective November 18, 2000, 30 Pa.B. 6911; reserved April 19, 2013, effective April 20, 2013, 43 Pa.B. 2145. Immediately preceding text appears at serial pages (272603) to (272604).

§ 18.56. [Reserved].


Authority

   The provisions of this §  18.56 issued under section 15(b) of the Medical Practice Act of 1985 (63 P. S. §  422.15(b)); and section 2(1) of the Professional Nursing Law (63 P. S. §  212(1)); reserved under section 8 of the Medical Practice Act of 1985 (63 P. S. §  422.8); and sections 2.1(k) and (l) and 8.1—8.3 of The Professional Nursing Law (63 P. S. § §  212.1(k) and (l) and 218.1—218.3).

Source

   The provisions of this §  18.56 adopted November 17, 2000, effective November 18, 2000, 30 Pa.B. 5943; reserved April 19, 2013, effective April 20, 2013, 43 Pa.B. 2145. Immediately preceding text appears at serial page (272604).

§ 18.57. [Reserved].


Authority

   The provisions of this §  18.57 issued under section 15(b) of the Medical Practice Act of 1985 (63 P. S. §  422.15(b)); and section 2(1) of the Professional Nursing Law (63 P. S. §  212(1)); reserved under section 8 of the Medical Practice Act of 1985 (63 P. S. §  422.8); and sections 2.1(k) and (l) and 8.1—8.3 of The Professional Nursing Law (63 P. S. § §  212.1(k) and (l) and 218.1—218.3).

Source

   The provisions of this §  18.57 adopted November 17, 2000, effective November 18, 2000, 30 Pa.B. 5943; reserved April 19, 2013, effective April 20, 2013, 43 Pa.B. 2145. Immediately preceding text appears at serial pages (272604) and (271695).

§ § 18.61—18.64. [Reserved].

§ 18.71. [Reserved].

§ 18.81. [Reserved].

§ 18.91. [Reserved].

§ 18.101. [Reserved].

§ 18.111. [Reserved].


Subchapter D. PHYSICIAN ASSISTANTS


GENERAL PROVISIONS

Sec.


18.121.    Purpose.
18.122.    Definitions.

PHYSICIAN ASSISTANT EDUCATIONAL PROGRAMS


18.131.    Recognized educational programs/standards.
18.132.    [Reserved].

LICENSURE OF PHYSICIAN ASSISTANTS AND
REGISTRATION OF SUPERVISING PHYSICIANS


18.141.    Criteria for certification as a physician assistant.
18.142.    Written agreements.
18.143.    Criteria for registration as a supervising physician.
18.144.    Responsibility of primary supervising physician.
18.145.    Biennial registration requirements; renewal of physician assistant license.
18.146.    Professional liability insurance coverage for licensed physician assistants.

PHYSICIAN ASSISTANT UTILIZATION


18.151.    Role of physician assistant.
18.152.    Prohibitions.
18.153.    Executing and relaying medical regimens.
18.154.    Substitute supervising physician.
18.155.    Satellite locations.
18.156.    Monitoring and review of physician assistant utilization.
18.157.    Administration of controlled substances and whole blood and blood components.
18.158.    Prescribing and dispensing drugs, pharmaceutical aids and devices.
18.159.    Medical records.

MEDICAL CARE FACILITIES AND EMERGENCY MEDICAL SERVICES


18.161.    Physician assistant employed by medical care facilities.
18.162.    Emergency medical services.
18.163.    [Reserved].
18.164.    [Reserved].

IDENTIFICATION AND NOTICE RESPONSIBILITIES


18.171.    Physician assistant identification.
18.172.    Notification of changes in employment.

DISCIPLINE


18.181.    Disciplinary and corrective measures.
18.182.    [Reserved].
18.183.    [Reserved].

Cross References

   This subchapter cited in 28 Pa. Code §  107.12a (relating to specified professional personnel—statement of policy); 52 Pa. Code §  56.2 (relating to definitions); and 52 Pa. Code §  56.252 (relating to definitions).

GENERAL PROVISIONS


§ 18.121. Purpose.

 This subchapter implements section 13 of the act (63 P. S. §  422.13) pertaining to physician assistants and provides for the delegation of certain medical tasks to qualified physician assistants by supervising physicians when the delegation is consistent with the written agreement.

Authority

   The provisions of this §  18.121 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.121 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (299569) to (299570).

§ 18.122. Definitions.

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

   ARC-PA—The Accreditation Review Commission.

   Administration—The direct application of a drug, whole blood, blood components, diagnostic procedure or device, whether by injection, inhalation, ingestion, skin application or other means, into the body of a patient.

   CAAHEP—The Commission for Accreditation of Allied Health Educational Programs.

   CAHEA—The Committee on Allied Health Education and Accreditation.

   Device—An instrument or tool necessary in the administration of medication or medical care.

   Dispense—To deliver a drug or device to or for an ultimate user for limited or continuing use.

   Drug—A term used to describe a medication, device or agent which a physician assistant prescribes or dispenses under §  18.158 (relating to prescribing and dispensing drugs, pharmaceutical aids and devices).

   Emergency medical care setting

     (i)   A health care setting which is established to provide emergency medical care as its primary purpose.

     (ii)   The term does not include a setting which provides general or specialized medical services that are not routinely emergency in nature even though that setting provides emergency medical care from time to time.

   Medical care facility—An entity licensed or approved to render health care services.

   Medical regimen—A therapeutic, corrective or diagnostic measure performed or ordered by a physician, or performed or ordered by a physician assistant acting within the physician assistant’s scope of practice, and in accordance with the written agreement between the supervising physician and the physician assistant.

   Medical service—An activity which lies within the scope of the practice of medicine and surgery.

   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.

   Order—An oral or written directive for a therapeutic, corrective or diagnostic measure, including a drug to be dispensed for onsite administration in a hospital, medical care facility or office setting.

   Physician—A medical doctor or doctor of osteopathic medicine.

   Physician assistant—An individual who is licensed as a physician assistant by the Board.

   Physician assistant examination—An examination to test whether an individual has accumulated sufficient academic knowledge to qualify for licensure as a physician assistant. The Board recognizes the certifying examination of the NCCPA.

   Physician assistant program—A program for the training and education of physician assistants which is recognized by the Board and accredited by the CAHEA, the CAAHEP, ARC-PA or a successor agency.

   Prescription

     (i)   A written or oral order for a drug or device to be dispensed to or for an ultimate user.

     (ii)   The term does not include an order for a drug which is dispensed for immediate administration to the ultimate user; for example, an order to dispense a drug to a patient for immediate administration in an office or hospital is not a prescription.

   Primary supervising physician—A medical doctor who is registered with the Board and designated in the written agreement as having primary responsibility for directing and personally supervising the physician assistant.

   Satellite location—A location, other than the primary place at which the supervising physician provides medical services to patients, where a physician assistant provides medical services.

   Substitute supervising physician—A supervising physician who is registered with the Board and designated in the written agreement as assuming primary responsibility for a physician assistant when the primary supervising physician is unavailable.

   Supervising physician—Each physician who is identified in a written agreement as a physician who supervises a physician assistant.

   Supervision

     (i)   Oversight and personal direction of, and responsibility for, the medical services rendered by a physician assistant. The constant physical presence of the supervising physician is not required so long as the supervising physician and the physician assistant are, or can be, easily in contact with each other by radio, telephone or other telecommunications device.

     (ii)   An appropriate degree of supervision includes:

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

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

       (C)   Personal and regular review within 10 days by the supervising physician of the patient records upon which entries are made by the physician assistant.

   Written agreement—The agreement between the physician assistant and supervising physician, which satisfies the requirements of §  18.142 (relating to written agreements).

Authority

   The provisions of this §  18.122 amended under sections 8, 8.1, 13, 13.1(c) and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.8a, 422.13, 422.13a(c) and 422.36).

Source

   The provisions of this §  18.122 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009; amended January 31, 2014, effective February 1, 2014, 44 Pa.B. 583. Immediately preceding text appears at serial pages (323418) to (323420).

Cross References

   This section cited in 49 Pa. Code §  33.205b (relating to practice as a public health dental hygiene practitioner).

PHYSICIAN ASSISTANT EDUCATIONAL PROGRAMS


§ 18.131. Recognized educational programs/standards.

 (a)  The Board recognizes physician assistant educational programs accredited by the American Medical Association’s CAHEA, the CAAHEP, ARC-PA or a successor organization. Information regarding accredited programs may be obtained directly from ARC-PA at its website: www.arc-pa.org.

 (b)  The criteria for recognition by the Board of physician assistant educational programs will be identical to the essentials developed by the various organizations listed in this section or other accrediting agencies approved by the Board.

Authority

   The provisions of this §  18.131 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.131 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial page (222920).

§ 18.132. [Reserved].


Source

   The provisions of this §  18.132 reserved August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780. Immediately preceding text appears at serial page (114044).

LICENSURE OF PHYSICIAN ASSISTANTS AND
REGISTRATION OF SUPERVISING PHYSICIANS


§ 18.141. Criteria for licensure as a physician assistant.

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

   (1)  Satisfies the licensure requirements in §  16.12 (relating to general qualifications for licenses and certificates) including the completion of at least 3 hours of approved training in child abuse recognition and reporting in accordance with §  16.108(a) (relating to child abuse recognition and reporting—mandatory training requirement).

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

   (3)  Has submitted a completed application together with the required fee, under §  16.13 (relating to licensure, certification, examination and registration fees).

   (4)  Has passed the physician assistant examination.

Authority

   The provisions of this §  18.141 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P.S. § §  422.8, 422.13 and 422.36); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.141 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009; amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial page (370211).

Cross References

   This section cited in 49 Pa. Code §  18.156 (relating to monitoring and review of physician assistant utilization).

§ 18.142. Written agreements.

 (a)  The written agreement required by section 13(e) of the act (63 P. S. §  422.13(e)) satisfies the following requirements. The agreement must:

   (1)  Identify and be signed by the physician assistant and each physician the physician assistant will be assisting who will be acting as a supervising physician. At least one physician shall be a medical doctor.

   (2)  Describe the manner in which the physician assistant will be assisting each named physician. The description must list functions to be delegated to the physician assistant.

   (3)  Describe the time, place and manner of supervision and direction each named physician will provide the physician assistant, including the frequency of personal contact with the physician assistant.

   (4)  Designate one of the named physicians who shall be a medical doctor as the primary supervising physician.

   (5)  Require that the supervising physician shall countersign the patient record completed by the physician assistant within a reasonable amount of time. This time period may not exceed 10 days.

   (6)  Identify the locations and practice settings where the physician assistant will serve.

 (b)  The written agreement shall be approved by the Board as satisfying the requirements in subsection (a) and as being consistent with relevant provisions of the act and regulations contained in this subchapter.

 (c)  A physician assistant or supervising physician shall provide immediate access to the written agreement to anyone seeking to confirm the scope of the physician assistant’s authority.

Authority

   The provisions of this §  18.142 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P.S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.142 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222921) to (222922).

Cross References

   This section cited in 49 Pa. Code §  18.122 (relating to definitions); 49 Pa. Code §  18.143 (relating to criteria for registration as a supervising physician); and 49 Pa. Code §  18.156 (relating to monitoring and review of physician assistant utilization).

§ 18.143. Criteria for registration as a supervising physician.

 (a)  The Board will register a supervising physician applicant who:

   (1)  Possesses a current license without restriction to practice medicine and surgery in this Commonwealth.

   (2)  Has filed a completed registration form accompanied by the written agreement (see §  18.142 (relating to written agreements)) and the required fee under §  16.13 (relating to licensure, certification, examination and registration fees). The registration requires detailed information regarding the physician’s professional background and specialties, medical education, internship, residency, continuing education, membership in American Boards of medical specialty, hospital or staff privileges and other information the Board may require.

   (3)  Includes with the registration, a list, identifying by name and license number, the other physicians who are serving as supervising physicians of the designated physician assistant under other written agreements.

 (b)  If the supervising physician plans to utilize physician assistants in satellite locations, the supervising physician shall provide the Board with supplemental information as set forth in §  18.155 (relating to satellite locations) and additional information requested by the Board directly relating to the satellite location.

 (c)  The Board will keep a current list of registered supervising physicians. The list will include the physician’s name, the address of residence, current business address, the date of filing, satellite locations if applicable, the names of current physician assistants under the physician’s supervision and the physicians willing to provide substitute supervision.

Authority

   The provisions of this §  18.143 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P.S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.143 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222922) to (222923).

§ 18.144. Responsibility of primary supervising physician.

 A primary supervising physician shall assume the following responsibilities. The supervisor shall:

   (1)  Monitor the compliance of all parties to the written agreement with the standards contained in the written agreement, the act and this subchapter.

   (2)  Advise any party to the written agreement of the failure to conform with the standards contained in the written agreement, the act and this subchapter.

   (3)  Arrange for a substitute supervising physician. (See §  18.154 (relating to substitute supervising physician).)

   (4)  Review directly with the patient the progress of the patient’s care as needed based upon the patient’s medical condition and prognosis or as requested by the patient.

   (5)  See each patient while hospitalized at least once.

   (6)  Provide access to the written agreement upon request and provide clarification of orders and prescriptions by the physician assistant relayed to other health care practitioners.

   (7)  Accept full professional and legal responsibility for the performance of the physician assistant and the care and treatment of the patients.

Authority

   The provisions of this §  18.144 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P.S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.144 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial page (222923).

Cross References

   This section cited in 49 Pa. Code §  18.156 (relating to monitoring and review of physician assistant utilization).

§ 18.145. Biennial registration requirements; renewal of physician assistant license.

 (a)  A physician assistant shall register biennially according to the procedure in §  16.15 (relating to biennial registration; inactive status and unregistered status).

 (b)  The fee for the biennial registration of a physician assistant license is set forth in §  16.13 (relating to licensure, certification, examination and registration fees).

 (c)  To be eligible for renewal of a physician assistant license, the physician assistant shall complete continuing medical education as required by the NCCPA, including at least 2 hours of approved training in child abuse recognition and reporting in accordance with §  16.108(b) (relating to child abuse recognition and reporting—mandatory training requirement), and maintain National certification by completing current recertification mechanisms available to the profession, identified on the NCCPA’s web site as recognized by the Board. The Board recognizes certification through the 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)  The Board will keep a current list of persons licensed as physician assistants. The list will include:

   (1)  The name of each physician assistant.

   (2)  The place of residence.

   (3)  The current business address.

   (4)  The date of initial licensure, biennial renewal record and current supervising physician.

Authority

   The provisions of this §  18.145 amended under sections 8, 8.1, 13, 13.1(c) and 36 of the Medical Practice Act of 1985 (63 P.S. § §  422.8, 422.8a, 422.13 422.13a(c) and 422.36); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.145 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009; amended January 31, 2014, effective February 1, 2014, 44 Pa.B. 583; amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial pages (370214) to (370215).

Cross References

   This section cited in 49 Pa. Code §  18.156 (relating to monitoring and review of physician assistant utilization).

§ 18.146. 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 36(f) of the act (63 P. S. §  422.36(f)).

 (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 36(f)(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 36(f) of the act may not practice as a physician assistant in this Commonwealth.

Authority

   The provisions of this §  18.146 issued under sections 8, 8.1, 13(c) and 13.1(c) of the Medical Practice Act of 1985 (63 P.S. § §  422.8, 422.8a, 422.13(c) and 422.13a(c)).

Source

   The provisions of this §  18.146 adopted January 31, 2014, effective February 1, 2014, 44 Pa.B. 583.

PHYSICIAN ASSISTANT UTILIZATION


§ 18.151. Role of physician assistant.

 (a)  The physician assistant practices medicine with physician supervision. A physician assistant may perform those duties and responsibilities, including the ordering, prescribing, dispensing, and administration of drugs and medical devices, as well as the ordering, prescribing, and executing of diagnostic and therapeutic medical regimens, as directed by the supervising physician.

 (b)  The physician assistant may provide any medical service as directed by the supervising physician when the service is within the physician assistant’s skills, training and experience, forms a component of the physician’s scope ofpractice, is included in the written agreement and is provided with the amount of supervision in keeping with the accepted standards of medical practice.

 (c)  The physician assistant may pronounce death, but not the cause of death, and may authenticate with the physician assistant’s signature any form related to pronouncing death. If the attending physician is not available, the physician assistant shall notify the county coroner. The coroner has the authority to release the body of the deceased to the funeral director.

 (d)  The physician assistant may authenticate with the physician assistant’s signature any form that may otherwise be authenticated by a physician’s signature as permitted by the supervising physician, State or Federal law and facility protocol, if applicable.

 (e)  The physician assistant shall be considered the agent of the supervising physician in the performance of all practice-related activities including the ordering of diagnostic, therapeutic and other medical services.

Authority

   The provisions of this §  18.151 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.151 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222924) to (222925).

Cross References

   This section cited in 49 Pa. Code §  18.142 (relating to written agreements).

§ 18.152. Prohibitions.

 (a)  A physician assistant may not:

   (1)  Provide medical services except as described in the written agreement.

   (2)  Prescribe or dispense drugs except as described in the written agreement.

   (3)  Maintain or manage a satellite location under §  18.155 (relating to satellite locations) unless the maintenance or management is registered with the Board.

   (4)  Independently practice or bill patients for services provided.

   (5)  Independently delegate a task specifically assigned to him by the supervising physician to another health care provider.

   (6)  List his name independently in a telephone directory or other directory for public use in a manner which indicates that he functions as an independent practitioner.

   (7)  Perform acupuncture except as permitted by section 13(k) of the act (63 P. S. §  422.13(k)).

   (8)  Perform a medical service without the supervision of a supervising physician.

 (b)  A supervising physician may not:

   (1)  Permit a physician assistant to engage in conduct proscribed in subsection (a).

   (2)  Have primary responsibility for more than two physician assistants.

Authority

   The provisions of this §  18.152 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.152 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222925) to (222926).

§ 18.153. Executing and relaying medical regimens.

 (a)  A physician assistant may execute a written or oral order for a medical regimen or may relay a written or oral order for a medical regimen to be executed by a health care practitioner subject to the requirements of this section.

 (b)  As provided for in the written agreement, the physician assistant shall report orally or in writing, to a supervising physician, within 36 hours, those medical regimens executed or relayed by the physician assistant while the supervising physician was not physically present, and the basis for each decision to execute or relay a medical regimen.

 (c)  The physician assistant shall record, date and authenticate the medical regimen on the patient’s chart at the time it is executed or relayed. When working in a medical care facility, a physician assistant may comply with the recordation requirement by directing the recipient of the order to record, date and authenticate that the recipient received the order, if this practice is consistent with the medical care facility’s written policies. The supervising physician shall countersign the patient record within a reasonable time not to exceed 10 days, unless countersignature is required sooner by regulation, policy within the medical care facility or the requirements of a third-party payor.

 (d)  A physician assistant or supervising physician shall provide immediate access to the written agreement to anyone seeking to confirm the physician assistant’s authority to relay a medical regimen or administer a therapeutic or diagnostic measure.

Authority

   The provisions of this §  18.153 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.153 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222926) to (222927).

§ 18.154. Substitute supervising physician.

 (a)  If the primary supervising physician is unavailable to supervise the physician assistant, the primary supervising physician may not delegate patient care to the physician assistant unless appropriate arrangements for substitute supervision are in the written agreement and the substitute physician is registered as a supervising physician with the Board.

 (b)  It is the responsibility of the substitute supervising physician to ensure that supervision is maintained in the absence of the primary supervising physician.

 (c)  During the period of supervision by the substitute supervising physician, the substitute supervising physician retains full professional and legal responsibility for the performance of the physician assistant and the care and treatment of the patients treated by the physician assistant.

 (d)  Failure to properly supervise may provide grounds for disciplinary action against the substitute supervising physician.

Authority

   The provisions of this §  18.154 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.154 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial page (222927).

Cross References

   This section cited in 49 Pa. Code §  18.144 (relating to responsibility of primary supervising physician); and 49 Pa. Code §  18.156 (relating to monitoring and review of physician assistant utilization).

§ 18.155. Satellite locations.

 (a)  Registration of satellite location. A physician assistant may not provide medical services at a satellite location unless the supervising physician has filed a registration with the Board.

 (b)  Contents of statement. A separate statement shall be made for each satellite location. The statement must demonstrate that:

   (1)  The physician assistant will be utilized in an area of medical need.

   (2)  There is adequate provision for direct communication between the physician assistant and the supervising physician and that the distance between the location where the physician provides services and the satellite location is not so great as to prohibit or impede appropriate support services.

   (3)  The supervising physician shall review directly with the patient the progress of the patient’s care as needed based upon the patient’s medical condition and prognosis or as requested by the patient.

   (4)  The supervising physician will visit the satellite location at least once every 10 days and devote enough time onsite to provide supervision and personally review the records of selected patients seen by the physician assistant in this setting. The supervising physician shall notate those patient records as reviewed.

 (c)  Failure to comply with this section. Failure to maintain the standards required for a satellite location may result not only in the loss of the privilege to maintain a satellite location but also may result in disciplinary action against the physician assistant and the supervising physician.

Authority

   The provisions of this §  18.155 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.155 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222927) to (222928).

Cross References

   This section cited in 49 Pa. Code §  18.143 (relating to criteria for registration as a supervising physician); and 49 Pa. Code §  18.152 (relating to prohibitions).

§ 18.156. Monitoring and review of physician assistant utilization.

 (a)  Representatives of the Board will be authorized to conduct scheduled and unscheduled onsite inspections of the locations where the physician assistants are utilized during the supervising physician’s office hours to review the following:

   (1)  Supervision of the physician assistant. See § §  18.144 and 18.154 (relating to responsibility of primary supervising physician; and substitute supervising physician).

   (2)  Presence of the written agreement and compliance with its terms. See §  18.142 (relating to written agreements).

   (3)  Utilization in conformity with the act, this subchapter and the written agreement.

   (4)  Appropriate identification of physician assistant. See §  18.171 (relating to physician assistant identification).

   (5)  Compliance with licensure and registration requirements. See § §  18.141 and 18.145 (relating to criteria for licensure as a physician assistant; and biennial registration requirements; renewal of physician assistant license).

   (6)  Maintenance of records evidencing patient and supervisory contact by the supervising physician.

 (b)  Reports shall be submitted to the Board and become a permanent record under the supervising physician’s registration. Deficiencies reported will be reviewed by the Board and may provide a basis for loss of the privilege to maintain a satellite location and disciplinary action against the physician assistant and the supervising physician.

 (c)  The Board reserves the right to review physician assistant utilization without prior notice to either the physician assistant or the supervising physician. It is a violation of this subchapter for a supervising physician or a physician assistant to refuse to comply with the request by the Board for the information in subsection (a).

 (d)  Additional inspections, including follow-up inspections may be conducted if the Board has reason to believe that a condition exists which threatens the public health, safety or welfare.

Authority

   The provisions of this §  18.156 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.156 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222928) to (222929).

§ 18.157. Administration of controlled substances and whole blood and blood components.

 (a)  In a hospital, medical care facility or office setting, the physician assistant may order or administer, or both, controlled substances and whole blood and blood components if the authority to order and administer these medications and fluids is expressly set forth in the written agreement.

 (b)  The physician assistant shall comply with the minimum standards for ordering and administering controlled substances specified in §  16.92 (relating to prescribing, administering and dispensing controlled substances).

Authority

   The provisions of this §  18.157 issued under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.157 adopted August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222929) to (222930).

Cross References

   This section cited in 49 Pa. Code §  18.151 (relating to role of physician assistant).

§ 18.158. Prescribing and dispensing drugs, pharmaceutical aids and devices.

 (a)  Prescribing, dispensing and administration of drugs.

   (1)  The supervising physician may delegate to the physician assistant the prescribing, dispensing and administering of drugs and therapeutic devices.

   (2)  A physician assistant may not prescribe or dispense Schedule I controlled substances as defined by section 4 of The Controlled Substances, Drug, Device, and Cosmetic Act (35 P. S. §  780-104).

   (3)  A physician assistant may prescribe a Schedule II controlled substance for initial therapy, up to a 72-hour dose. The physician assistant shall notify the supervising physician of the prescription as soon as possible, but in no event longer than 24 hours from the issuance of the prescription. A physician assistant may write a prescription for a Schedule II controlled substance for up to a 30-day supply if it was approved by the supervising physician for ongoing therapy. The prescription must clearly state on its face that it is for initial or ongoing therapy.

   (4)  A physician assistant may only prescribe or dispense a drug for a patient who is under the care of the physician responsible for the supervision of the physician assistant and only in accordance with the supervising physician’s instructions and written agreement.

   (5)  A physician assistant may request, receive and sign for professional samples and may distribute professional samples to patients.

   (6)  A physician assistant authorized to prescribe or dispense, or both, controlled substances shall register with the Drug Enforcement Administration (DEA).

 (b)  Prescription blanks. The requirements for prescription blanks are as follows:

   (1)  Prescription blanks must bear the license number of the physician assistant and the name of the physician assistant in a printed format at the heading of the blank. The supervising physician must also be identified as required in §  16.91 (relating to identifying information on prescriptions and orders for equipment and service).

   (2)  The signature of a physician assistant shall be followed by the initials ‘‘PA-C’’ or similar designation to identify the signer as a physician assistant. When appropriate, the physician assistant’s DEA registration number must appear on the prescription.

   (3)  The supervising physician is prohibited from presigning prescription blanks.

   (4)  The physician assistant may use a prescription blank generated by a hospital provided the information in paragraph (1) appears on the blank.

 (c)  Inappropriate prescription. The supervising physician shall immediately advise the patient, notify the physician assistant and, in the case of a written prescription, advise the pharmacy if the physician assistant is prescribing or dispensing a drug inappropriately. The supervising physician shall advise the patient and notify the physician assistant to discontinue using the drug and, in the case of a written prescription, notify the pharmacy to discontinue the prescription. The order to discontinue use of the drug or prescription shall be noted in the patient’s medical record by the supervising physician.

 (d)  Recordkeeping requirements. Recordkeeping requirements are as follows:

   (1)  When prescribing a drug, the physician assistant shall keep a copy of the prescription, including the number of refills, in a ready reference file, or record the name, amount and doses of the drug prescribed, the number of refills, the date of the prescription and the physician assistant’s name in the patient’s medical records.

   (2)  When dispensing a drug, the physician assistant shall record the physician assistant’s name, the name of the medication dispensed, the amount of medication dispensed, the dose of the medication dispensed and the date dispensed in the patient’s medical records.

   (3)  The physician assistant shall report, orally or in writing, to the supervising physician within 36 hours, a drug prescribed or medication dispensed by the physician assistant while the supervising physician was not physically present, and the basis for each decision to prescribe or dispense in accordance with the written agreement.

   (4)  The supervising physician shall countersign the patient record within 10 days.

   (5)  The physician assistant and the supervising physician shall provide immediate access to the written agreement to anyone seeking to confirm the physician assistant’s authority to prescribe or dispense a drug. The written agreement must list the categories of drugs which the physician assistant is not permitted to prescribe.

 (e)  Compliance with regulations relating to prescribing, administering, dispensing, packaging and labeling of drugs. A physician assistant shall comply with § §  16.92—16.94 (relating to prescribing, administering and dispensing controlled substances; packaging; and labeling of dispensed drugs) and Department of Health regulations in 28 Pa. Code § §  25.51—25.58 (relating to prescriptions) and regulations regarding packaging and labeling dispensed drugs. See §  16.94 and 28 Pa. Code § §  25.91—25.95 (relating to labeling of drugs, devices and cosmetics).

Authority

   The provisions of this §  18.158 issued under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.158 adopted August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222930) to (222933).

Cross References

   This section cited in 49 Pa. Code §  18.122 (relating to definitions); and 49 Pa. Code §  18.151 (relating to role of physician assistant).

§ 18.159. Medical records.

 The supervising physician shall timely review, not to exceed 10 days, the medical records prepared by the physician assistant to ensure that the requirements of §  16.95 (relating to medical records) have been satisfied.

Authority

   The provisions of this §  18.159 issued under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.159 adopted August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial page (222934).

MEDICAL CARE FACILITIES AND EMERGENCY
MEDICAL SERVICES


§ 18.161. Physician assistant employed by medical care facilities.

 (a)  A physician assistant may be employed by a medical care facility, but shall comply with the requirements of the act and this subchapter.

 (b)  The physician assistant may not be responsible to more than three supervising physicians in a medical care facility.

 (c)  This subchapter does not require medical care facilities to employ physician assistants or to permit their utilization on their premises. Physician assistants are permitted to provide medical services to the hospitalized patients of their supervising physicians if the medical care facility permits it.

 (d)  Physician assistants granted privileges by, or practicing in, a medical care facility shall conform to policies and requirements delineated by the facility.

Authority

   The provisions of this §  18.161 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.161 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial page (222934).

§ 18.162. Emergency medical services.

 (a)  A physician assistant may only provide medical service in an emergency medical care setting if the physician assistant has training in emergency medicine, functions within the purview of the physician assistant’s written agreement and is under the supervision of the supervising physician.

 (b)  A physician assistant licensed in this Commonwealth or licensed or authorized to practice in any other state who is responding to a need for medical care created by a declared state of emergency or a state or local disaster (not to be defined as an emergency situation which occurs in the place of one’s employment) may render care consistent with relevant standards of care.

Authority

   The provisions of this §  18.162 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.162 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222934) to (222935).

§ 18.163. [Reserved].


Source

   The provisions of this §  18.163 reserved August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780. Immediately preceding text appears at serial page (114052).

§ 18.164. [Reserved].


Source

   The provisions of this §  18.164 reserved August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780. Immediately preceding text appears at serial page (114053).

IDENTIFICATION AND NOTICE RESPONSIBILITIES


§ 18.171. Physician assistant identification.

 (a)  A physician assistant may not render medical services to a patient until the patient or the patient’s legal guardian has been informed that:

   (1)  The physician assistant is not a physician.

   (2)  The physician assistant may perform the service required as the agent of the physician and only as directed by the supervising physician.

   (3)  The patient has the right to be treated by the physician if the patient desires.

 (b)  It is the supervising physician’s 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 satellite locations, a notice plainly visible to patients shall be posted in a prominent place explaining that a ‘‘physician assistant’’ is authorized to assist a physician in the provision of medical care and services. The supervising physician shall display the registration to supervise in the office. The physician assistant’s license shall be prominently displayed at any location at which the physician assistant provides services. Duplicate licenses may be obtained from the Board if required.

 (d)  The physician assistant shall wear an identification tag which uses the term ‘‘Physician Assistant’’ in easily readable type. The tag shall be conspicuously worn.

Authority

   The provisions of this §  18.171 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.171 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222935) to (222936).

Cross References

   This section cited in 49 Pa. Code §  18.156 (relating to monitoring and review of physician assistant utilization).

§ 18.172. Notification of changes in employment.

 (a)  The physician assistant is required to notify the Board, in writing, of a change in or termination of employment or a change in mailing address within 15 days. Failure to notify the Board, in writing, of a change in mailing address may result in failure to receive pertinent material distributed by the Board. The physician assistant shall provide the Board with the new address of residence, address of employment and name of registered supervising physician.

 (b)  The supervising physician is required to notify the Board, in writing, of a change or termination of supervision of a physician assistant within 15 days.

 (c)  Failure to notify the Board of changes in employment or a termination in the physician/physician assistant relationship is a basis for disciplinary action against the physician’s license, supervising physician’s registration and the physician assistant’s license.

Authority

   The provisions of this §  18.172 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.172 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial page (222936).

DISCIPLINE


§ 18.181. Disciplinary and corrective measures.

 (a)  A physician assistant who engages in unprofessional conduct is subject to disciplinary action under section 41 of the act (63 P. S. §  422.41). Unprofessional conduct includes the following:

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

   (2)  Commission of an offense against the statutes of the Commonwealth relating to the practice of physician assistants or regulations adopted thereunder.

   (3)  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 this Commonwealth. If the act constitutes a crime, conviction thereof in a criminal proceeding may not be a condition precedent to disciplinary action.

   (4)  Conviction of a felony or conviction of a misdemeanor relating to a health profession or receiving probation without verdict, disposition in lieu of trial or an accelerated rehabilitative disposition in the disposition of felony charges, in the courts of the Commonwealth, a Federal court or a court of another State, territory or country.

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

   (6)  Performance of 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)  Offer, undertake or agree to cure or treat disease by a secret method, procedure, treatment or medicine; the treating, prescribing for a human condition, by a method, means or procedure which the physician assistant refuses to divulge upon demand of the Board; or 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 a provision of this subchapter fixing a standard of professional conduct.

   (10)  Continuation of practice while the physician assistant’s license has expired, is not registered or is suspended or revoked.

   (11)  Delegating a medical responsibility to a person when the physician assistant knows or has reason to know that the person is not qualified by training, experience, license or certification to perform the delegated task.

   (12)  The failure to notify the supervising physician that the physician assistant has withdrawn care from a patient.

 (b)  The Board will order the emergency suspension of the license of a physician assistant who presents an immediate and clear danger to the public health and safety, as required by section 40 of the act (63 P. S. §  422.40).

 (c)  The license of a physician assistant shall automatically be suspended, under conditions in section 40 of the act.

 (d)  The Board may refuse, revoke or suspend a physician’s registration as a supervising physician for engaging in any of the conduct proscribed of Board-regulated practitioners in section 41 of the act.

Authority

   The provisions of this §  18.181 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.181 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222936) to (222938).

§ 18.182. [Reserved].


Source

   The provisions of this §  18.182 reserved August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780. Immediately preceding text appears at serial page (159345).

§ 18.183. [Reserved].


Source

   The provisions of this §  18.183 reserved August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780. Immediately preceding text appears at serial page (159345).

Subchapter E. PERFORMANCE OF RADIOLOGIC PROCEDURES BY AUXILIARY PERSONNEL


Sec.


18.201.    Definitions.
18.202.    Auxiliary personnel performing radiologic procedures.
18.203.    Applications for examination.
18.204.    Effective date.

§ 18.201. Definitions.

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

   ARRT—The American Registry of Radiologic Technologists.

   Auxiliary personnel—Persons other than a medical doctor, osteopathic doctor, dentist, podiatrist or chiropractor.

   Direct supervision—Directly controlling the performance of a procedure by authorizing performance of that procedure only under the specific instructions of the medical doctor, and monitoring performance of the procedure to ensure compliance with those instructions.

   Ionizing radiation—Gamma rays and X-rays, alpha and beta particles, high-speed electrons, neutrons, protons and other nuclear particles. The term does not include ultrasound, sound or radio waves or visible, infrared or ultraviolet light.

   Premises of a medical doctor—A location at which the medical doctor practices medicine, other than a health care facility regulated by the Department of Health, the Department of Public Welfare or the Federal government.

   Radiologic procedure—The use of ionizing radiation for a diagnostic or therapeutic purpose.

Authority

   The provisions of this §  18.201 issued under sections 6 and 8 of the Medical Practice Act of 1985 (63 P. S. § §  422.6 and 422.8).

Source

   The provisions of this §  18.201 adopted July 17, 1987, effective July 18, 1987, 17 Pa.B. 3021.

§ 18.202. Auxiliary personnel performing radiologic procedures.

 (a)  Auxiliary personnel who take the ARRT Examination in Radiography, and who pass that examination as determined by ARRT, or who have been certified by ARRT, or by another certifying body recognized by the Board, as the result of satisfactory completion of a test and an educational course accredited by an accrediting body recognized by the Board, as a radiologic technologist in radiography, may apply ionizing radiation to human beings for diagnostic purposes on the premises of a medical doctor under the direct supervision of that medical doctor. The medical doctor is not required to personally observe performance of the procedure.

 (b)  Auxiliary personnel who take the ARRT Examination in Radiation Therapy Technology, and who pass that examination as determined by ARRT, or who have been certified by ARRT, or by another certifying body recognized by the Board, as the result of satisfactory completion of a test and an educational course accredited by an accrediting body recognized by the Board, in radiation therapy technology, may apply ionizing radiation to human beings for therapeutic purposes on the premises of a medical doctor under the direct supervision of that medical doctor. The medical doctor is not required to personally observe performance of the procedure. The medical doctor shall be on the premises when a radiographic procedure is performed for a therapeutic purpose by an auxiliary person.

 (c)  Auxiliary personnel who take the ARRT Examination in Nuclear Medicine Technology, and who pass that examination as determined by ARRT, or who have been certified by ARRT, or by another certifying body recognized by the Board, as the result of satisfactory completion of a test and an educational course accredited by an accrediting body recognized by the Board, in nuclear medicine technology, may use radionuclide agents on human beings for diagnostic or therapeutic purposes on the premises of a medical doctor under the direct supervision of that medical doctor. The medical doctor is not required to personally observe performance of the procedure. The medical doctor shall be on the premises when a radionuclide agent is used by an auxiliary person for a therapeutic purpose.

 (d)  Auxiliary personnel who take the ARRT Limited Examination in Radiography, and who receive a score of 70 or higher on that examination as determined by ARRT, may use ionizing radiation on the thorax and extremities of human beings for diagnostic purposes on the premises of a medical doctor under the direct supervision of that medical doctor. The medical doctor is not required to personally observe the performance of the procedure. The use of ionizing radiation is restricted to producing radiographs of the thorax and the extremities to demonstrate the following:

   (1)  Ankle.

   (2)  Chest.

   (3)  Clavicle.

   (4)  Elbow.

   (5)  Femur.

   (6)  Foot.

   (7)  Hand.

   (8)  Humerus.

   (9)  Knee.

   (10)  Radius and ulna.

   (11)  Scapula.

   (12)  Shoulder.

   (13)  Soft tissue (foreign body localization).

   (14)  Tibia and fibula.

   (15)  Wrist.

 (e)  Auxiliary personnel who take the ARRT Limited Examination in Radiography—Skull and Sinuses, and who receive a score of 70 or higher on that examination as determined by ARRT, may use ionizing radiation on the skull and sinuses of human beings for diagnostic purposes on the premises of the medical doctor under the direct supervision of that medical doctor. The medical doctor is not required to personally observe the performance of the procedure. The use of ionizing radiation is restricted to producing radiographs of the skull and sinuses to demonstrate the following:

   (i)  Facial bones.

   (ii)  Mandible.

   (iii)  Paranasal sinuses.

   (iv)  Skull.

 (f)  Auxiliary personnel who take the Examination in Nuclear Medicine Technology of the Nuclear Medicine Technology College Board, and who pass that examination as determined by the Nuclear Medicine Technology College Board, or who have been certified by the Nuclear Medicine Technology College Board as a radiologic technologist in nuclear medicine technology as the result of satisfactory completion of a test and an educational course accredited by an accrediting body recognized by the Board, may use radionuclide agents on human beings for diagnostic or therapeutic purposes on the premises of a medical doctor under the direct supervision of that medical doctor. The medical doctor is not required to personally observe performance of the procedure. The medical doctor shall be on the premises when a radionuclide agent is used by an auxiliary person for a therapeutic purpose.

 (g)  A person licensed by the State Board of Dentistry as a dental hygienist may use ionizing radiation on the maxilla, mandible and adjacent structures of human beings, to produce radiographs of those structures for diagnostic purposes, on the premises of a medical doctor under the direct supervision of that medical doctor. The medical doctor is not required to personally observe the performance of the procedure.

Authority

   The provisions of this §  18.202 issued under sections 6 and 8 of the Medical Practice Act of 1985 (63 P. S. § §  422.6 and 422.8); section 812.1 of The Administrative Code of 1929 (71 P. S. §  279.3a); and amended under sections 6, 8 and 25 of the Medical Practice Act of 1985 (63 P. S. § §  422.6, 422.8 and 422.25).

Source

   The provisions of this §  18.202 adopted July 17, 1987, effective July 18, 1987, 17 Pa.B. 3021; amended May 24, 1991, effective May 25, 1991, 21 Pa.B. 2489. Immediately preceding text appears at serial pages (119274) to (119276).

Cross References

   This section cited in 49 Pa. Code §  18.203 (relating to applications for examination).

§ 18.203. Applications for examination.

 (a)  A person may apply to take one or more of the following examinations by securing an application from the Bureau of Professional and Occupational Affairs, and by submitting the application and the fee required under §  16.13 (relating to licensure, certification, examination and registration fees) to Health Boards, Bureau of Professional and Occupational Affairs, Post Office Box 2649, Harrisburg, Pennsylvania 17105-2649:

   (1)  ARRT Examination in Radiography.

   (2)  ARRT Examination in Radiation Therapy Technology.

   (3)  ARRT Examination in Nuclear Medicine Technology.

   (4)  ARRT Limited Examination in Radiography.

   (5)  ARRT Limited Examination in Radiography—Skull and Sinuses.

 (b)  The examinations listed in subsection (a) are administered in this Commonwealth on the third Thursday of March, July and October. Applications to the Board for the March examination shall be received by December 31, applications for the July examination shall be received by April 30 and applications for the October examination shall be received by July 31.

 (c)  Applications for the ARRT examinations in radiography, radiation therapy technology and nuclear medicine technology may be filed directly with ARRT. ARRT is a private certifying body and may require the satisfaction of minimum education and training criteria for certification purposes. An examination application may not be filed with ARRT if the applicant wishes to take the ARRT Limited Examination in Radiography or the ARRT Limited Examination in Radiography—Skull and Sinuses, or if the applicant does not qualify for or desire private certification of competence to perform the radiologic procedures covered by the other ARRT certification examinations. Alternatively, an application shall be filed with ARRT and not with the Bureau of Professional and Occupational Affairs if the applicant desires to not only perform radiologic procedures as authorized in §  18.202 (relating to auxiliary personnel performing radiologic procedures), but also desires certification by ARRT in the field of radiologic procedures covered by the examination.

Authority

   The provisions of this §  18.203 issued under sections 6 and 8 of the Medical Practice Act of 1985 (63 P. S. § §  422.6 and 422.8); section 812.1 of The Administrative Code of 1929 (71 P. S. §  279.3a); and amended under sections 6, 8 and 25 of the Medical Practice Act of 1985 (63 P. S. § §  422.6, 422.8 and 422.25).

Source

   The provisions of this §  18.203 adopted July 17, 1987, effective July 18, 1987, 17 Pa.B. 3021; amended May 24, 1991, effective May 25, 1991, 21 Pa.B. 2489. Immediately preceding text appears at serial pages (119276) to (119277).

Cross References

   This section cited in 49 Pa. Code §  18.204 (relating to effective date).

§ 18.204. Effective date.

 The Bureau of Professional and Occupational Affairs will begin accepting applications to take examinations set forth in §  18.203(a) (relating to applications for examination) prior to July 18, 1987. Under section 45 of the act (63 P. S. §  422.45), on and after January 1, 1988, no auxiliary person may administer radiologic procedures on the premises of a medical doctor except as set forth in this subchapter and section 45 of the act.

Authority

   The provisions of this §  18.204 issued under sections 6 and 8 of the Medical Practice Act of 1985 (63 P. S. § §  422.6 and 422.8); and section 812.1 of The Administrative Code of 1929 (71 P. S. §  279.3a).

Source

   The provisions of this §  18.204 adopted July 17, 1987, effective July 18, 1987, 17 Pa.B. 3021.

Subchapter F. RESPIRATORY THERAPISTS


Sec.


18.301.    Purpose.
18.302.    Definitions.
18.303.    [Reserved].
18.304.    Licensure of respiratory therapists; practice; exceptions.
18.305.    Functions of respiratory therapists.
18.306.    Temporary permits.
18.307.    Criteria for licensure as a respiratory therapist.
18.308.    Change of name or address.
18.309.    Renewal of licensure.
18.309a.    Requirement of continuing education.
18.309b.    Approved educational courses.
18.310.    Inactive status.

Authority

   The provisions of this Subchapter F issued under sections 13.1(c) and 36.1 of the Medical Practice Act of 1985 (63 P. S. § §  422.13a and 422.36a); and sections 10.1(c) and 10.2 of the Osteopathic Medical Practice Act (63 P. S. § §  271.10a(c) and 271.10b), unless otherwise noted.

Source

   The provisions of this Subchapter F adopted November 15, 1996, effective November 16, 1996, 26 Pa.B. 5641, unless noted.

§ 18.301. Purpose.

 This subchapter implements sections 13.1 and 36.1 of the act (63 P. S. § §  422.13a and 422.36a), which were added by section 3 of the act of July 2, 1993 (P. L. 424, No. 60) to provide for the licensure of respiratory therapists.

Authority

   The provisions of this §  18.301 amended under sections 8, 8.1, 13(c) and 13.1(c) of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.8a, 422.13(c) and 422.13a(c)).

Source

   The provisions of this §  18.301 amended January 31, 2014, effective February 1, 2014, 44 Pa.B. 583. Immediately preceding text appears at serial page (360896).

§ 18.302. 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 and approves continuing professional development programs.

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

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

   Act—The Medical Practice Act of 1985 (63 P. S. § §  422.1—422.5(a)).

   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 and approves continuing professional development programs.

   Continuing education hour—Fifty minutes of continuing education.

   NBRC—The National Board for Respiratory Care, the agency recognized by the Board to credential 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.

Authority

   The provisions of this §  18.302 amended under sections 8, 8.1, 13(c) and 13.1(c) of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.8a, 422.13(c) and 422.13a(c)).

Source

   The provisions of this §  18.302 amended August 11, 2006, effective August 12, 2006, 36 Pa.B. 4466; amended January 31, 2014, effective February 1, 2014, 44 Pa.B. 583. Immediately preceding text appears at serial page (360896).

§ 18.303. [Reserved].


Source

   The provisions of this §  18.303 reserved January 11, 2002, effective January 12, 2002, 32 Pa.B. 249. Immediately preceding text appears at serial pages (222943) to (222944).

§ 18.304. 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 Osteopathic Medicine under Chapter 25 (relating to State Board of Osteopathic Medicine), or is exempted under section 13.1(e) of the act (63 P. S. §  422.13a(e)) or section 10.1(e) of the Osteopathic Medical Practice Act (63 P. S. §  271.10a(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 Osteopathic Medicine and only while working under the supervision of a licensed physician.

Authority

   The provisions of this §  18.304 amended under sections 8, 8.1, 13(c) and 13.1(c) of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.8a, 422.13(c) and 422.13a(c)).

Source

   The provisions of this §  18.304 amended January 31, 2014, effective February 1, 2014, 44 Pa.B. 583. Immediately preceding text appears at serial page (323443).

§ 18.305. Functions of respiratory therapists.

 (a)  Under section 13.1(d) of the act (63 P. S. §  422.13a(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 13.1(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.

Authority

   The provisions of this §  18.305 amended under sections 8, 8.1, 13(c) and 13.1(c) of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.8a, 422.13(c) and 422.13a(c)).

Source

   The provisions of this §  18.305 amended January 31, 2014, effective February 1, 2014, 44 Pa.B. 583. Immediately preceding text appears at serial pages (323443) to (323444).

§ 18.306. 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 all 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.

Authority

   The provisions of this §  18.306 amended under sections 8, 8.1, 13(c) and 13.1(c) of the Medical Practice Act of 1985 (63 P.S. § §  422.8, 422.8a, 422.13(c) and 422.13a(c)).

Source

   The provisions of this §  18.306 amended January 31, 2014, effective February 1, 2014, 44 Pa.B. 583. Immediately preceding text appears at serial page (323444).

§ 18.307. 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.

   (3)  Has completed at least 3 hours of approved training in child abuse recognition and reporting in accordance with §  16.108(a) (relating to child abuse recognition and reporting—mandatory training requirement).

Authority

   The provisions of this §  18.307 amended under sections 8, 8.1, 13(c) and 13.1(c) of the Medical Practice Act of 1985 (63 P.S. § §  422.8, 422.8a, 422.13(c) and 422.13a(c)); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.307 amended January 31, 2014, effective February 1, 2014, 44 Pa.B. 583; amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial page (370221).

§ 18.308. Change of name or address.

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

Authority

   The provisions of this §  18.308 amended under sections 8, 8.1, 13(c) and 13.1(c) of the Medical Practice Act of 1985 (63 P.S. § §  422.8, 422.8a, 422.13(c) and 422.13a(c)).

Source

   The provisions of this §  18.308 amended January 31, 2014, effective February 1, 2014, 44 Pa.B. 583. Immediately preceding text appears at serial page (323444).

§ 18.309. 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, complete the continuing education requirement set forth in §  18.309a (relating to requirement of continuing education) and pay the required fee 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.

Authority

   The provisions of this §  18.309 amended under sections 8, 8.1, 13(c) and 13.1(c) of the Medical Practice Act of 1985 (63 P.S. § §  422.8, 422.8a, 422.13(c) and 422.13a(c)).

Source

   The provisions of this §  18.309 amended August 11, 2006, effective August 12, 2006, 36 Pa.B. 4466; amended January 31, 2014, effective February 1, 2014, 44 Pa.B. 583. Immediately preceding text appears at serial page (323445).

§ 18.309a. Requirement of continuing education.

 (a)  The following continuing education requirements shall be completed each biennial cycle:

   (1)  An applicant for biennial renewal or reactivation of licensure is required to complete, during the 2 years preceding the application for renewal or reactivation, a minimum of 30 hours of continuing education as set forth in section 36.1(f)(2) of the act (63 P.S. §  422.36a(f)(2)).

   (2)  At least 10 continuing education hours shall be obtained through classroom lecture, clinical presentation, real-time web-cast or other live sessions where a presenter is involved.

   (3)  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. To qualify for credit, the provider shall make available documented verification of completion of the course or program.

   (4)  One continuing education hour shall be completed in medical ethics, 1 continuing education hour shall be completed in patient safety and at least 2 hours shall be completed in child abuse recognition and reporting in accordance with §  16.108(b) (relating to child abuse recognition and reporting—mandatory training requirement).

   (5)  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.

   (6)  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, other demonstrated 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 in whole or in part of the 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 supporting completion of the hours of continuing education required, or the waiver granted, for at least 2 years after the conclusion 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.

Authority

   The provisions of this §  18.309a amended under sections 8, 8.1, 13(c) and 13.1(c) of the Medical Practice Act of 1985 (63 P.S. § §  422.8, 422.8a, 422.13(c) and 422.13a(c)); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.309a adopted August 11, 2006, effective August 12, 2006, 36 Pa.B. 4466; amended January 31, 2014, effective February 1, 2014, 44 Pa.B. 583; amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial pages (370222) to (370223).

Cross References

   This section cited in 49 Pa. Code §  18.309 (relating to renewal of licensure).

§ 18.309b. Approved educational courses.

 (a)  The Board approves respiratory care continuing education programs designated for professional development credits by the AARC, the AMA, the AOA and the CSRT. The courses, locations and instructors provided by these organizations for continuing education in respiratory care are deemed approved by the Board. Qualifying AMA continuing education programs shall be in AMA PRA Category I as defined in §  16.1 (relating to definitions) and qualifying AOA continuing education programs shall be in Category 1A and 1B.

 (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 is also approved for continuing education credit by the Board. Advanced course work is any course work beyond the academic requirements necessary for licensure as a respiratory therapist. Proof of completion of the academic credits shall be submitted to the Board for determination of number of continuing education hours completed.

 (c)  The Board will not accept courses of study which do not relate to the clinical aspects of respiratory care, such as studies in office management or practice building.

Authority

   The provisions of this §  18.309b amended under sections 8, 8.1, 13(c) and 13.1(c) of the Medical Practice Act of 1985 (63 P.S. § §  422.8, 422.8a, 422.13(c) and 422.13a(c)).

Source

   The provisions of this §  18.309b adopted August 11, 2006, effective August 12, 2006, 36 Pa.B. 4466; amended January 31, 2014, effective February 1, 2014, 44 Pa.B. 583. Immediately preceding text appears at serial page (323446).

§ 18.310. 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 biennial periods in which the applicant did not engage in practice in this Commonwealth.

Authority

   The provisions of this §  18.310 amended under sections 8, 8.1, 13(c) and 13.1(c) of the Medical Practice Act of 1985 (63 P.S. § §  422.8, 422.8a, 422.13(c) and 422.13a(c)).

Source

   The provisions of this §  18.310 amended January 31, 2014, effective February 1, 2014, 44 Pa.B. 583. Immediately preceding text appears at serial page (366377).

Subchapter G. MEDICAL DOCTOR DELEGATION OF
MEDICAL SERVICES


Sec.


18.401.    Definitions.
18.402.    Delegation.

Authority

   The provisions of this Subchapter G issued under section 17(b) of the Medical Practice Act of 1985 (63 P. S. §  422.17(b)), unless otherwise noted.

Source

   The provisions of this Subchapter G adopted January 2, 2004, effective January 3, 2004, 33 Pa.B. 43, unless otherwise noted.

§ 18.401. Definitions.

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

   Emergency medical services personnel—Individuals who deliver emergency medical services and who are regulated by the Department of Health under the Emergency Medical Services Act (35 P. S. § §  6921—6938).

§ 18.402. Delegation.

 (a)  A medical doctor may delegate to a health care practitioner or technician the performance of a medical service if the following conditions are met:

   (1)  The delegation is consistent with the standards of acceptable medical practice embraced by the medical doctor community in this Commonwealth. Standards of acceptable medical practice may be discerned from current peer reviewed medical literature and texts, teaching facility practices and instruction, the practice of expert practitioners in the field and the commonly accepted practice of practitioners in the field.

   (2)  The delegation is not prohibited by the statutes or regulations relating to other health care practitioners.

   (3)  The medical doctor has knowledge that the delegatee has education, training, experience and continued competency to safely perform the medical service being delegated.

   (4)  The medical doctor has determined that the delegation to a health care practitioner or technician does not create an undue risk to the particular patient being treated.

   (5)  The nature of the service and the delegation of the service has been explained to the patient and the patient does not object to the performance by the health care practitioner or technician. Unless otherwise required by law, the explanation may be oral and may be given by the physician or the physician’s designee.

   (6)  The medical doctor assumes the responsibility for the delegated medical service, including the performance of the service, and is available to the delegatee as appropriate to the difficulty of the procedure, the skill of the delegatee and risk level to the particular patient.

 (b)  A medical doctor may not delegate the performance of a medical service if performance of the medical service or if recognition of the complications or risks associated with the delegated medical service requires knowledge and skill not ordinarily possessed by nonphysicians.

 (c)  A medical doctor may not delegate a medical service which the medical doctor is not trained, qualified and competent to perform.

 (d)  A medical doctor is responsible for the medical services delegated to the health care practitioner or technician.

 (e)  A medical doctor may approve a standing protocol delegating medical acts to another health care practitioner who encounters a medical emergency that requires medical services for stabilization until the medical doctor or emergency medical services personnel are available to attend to the patient.

 (f)  This section does not prohibit a health care practitioner who is licensed or certified by a Commonwealth agency from practicing within the scope of that license or certificate or as otherwise authorized by law. For example, this section is not intended to restrict the practice of certified registered nurse anesthetists, nurse midwives, certified registered nurse practitioners, physician assistants, or other individuals practicing under the authority of specific statutes or regulations.

Subchapter H. ATHLETIC TRAINERS


Sec.


18.501.    Purpose.
18.502.    Definitions.
18.503.    Licensure requirement.
18.504.    Application for licensure.
18.505.    Educational requirements.
18.506.    Examination requirement.
18.507.    Temporary licensure.
18.508.    Renewal of license.
18.509.    Practice standards for athletic trainers.
18.510.    Refusal, suspension or revocation of license.
18.511.    Continuing education.

Authority

   The provisions of this Subchapter H issued under section 51.1 of the Medical Practice Act of 1985 (63 P.S. §  422.51a(d)); amended under sections 8 and 51.1(d) of the Medical Practice Act of 1985 (63 P.S. § §  422.8 and 422.51a(d)), unless otherwise noted.

Source

   The provisions of this Subchapter H adopted July 13, 2007, effective July 14, 2007, 37 Pa.B. 3230; amended April 19, 2013, effective April 20, 2013, 43 Pa.B. 2142, unless otherwise noted. Immediately preceding text appears at serial pages (328704), (348679) to (348682) and (361225).

§ 18.501. Purpose.

 This subchapter implements section 51.1 of the act (63 P. S. §  422.51a) to provide for the licensure and practice standards of athletic trainers.

§ 18.502. Definitions.

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

   Approved athletic training education programs—An athletic training education program that is accredited by a Board-approved Nationally recognized accrediting agency.

   Athletic training services—The management and provision of care of injuries to a physically active person, with the direction of a licensed physician.

     (i)   The term includes the rendering of emergency care, development of injury prevention programs and providing appropriate preventative and supportive devices for the physically active person.

     (ii)   The term also includes the assessment, management, treatment, rehabilitation and reconditioning of the physically active person whose conditions are within the professional preparation and education of a licensed athletic trainer.

     (iii)   The term also includes the use of modalities such as: mechanical stimulation, heat, cold, light, air, water, electricity, sound, massage and the use of therapeutic exercise, reconditioning exercise and fitness programs.

     (iv)   The term does not include surgery, invasive procedures or prescription of any medication or controlled substance.

   BOC—The Board of Certification, Inc., a National credentialing organization for athletic trainers.

   Direction—Supervision over the actions of a licensed athletic trainer by means of referral by prescription to treat conditions for a physically active person from a licensed physician, dentist or podiatrist or written protocol approved by a supervising physician, except that the physical presence of the supervising physician, dentist or podiatrist is not required if the supervising physician, dentist or podiatrist is readily available for consultation by direct communication, radio, telephone, facsimile, telecommunications or by other electronic means.

   Licensed athletic trainer—A person who is licensed to perform athletic training services by the Board or the State Board of Osteopathic Medicine.

   Physically active person—An individual who participates in organized, individual or team sports, athletic games or recreational sports activities.

   Referral—An order from a licensed physician, dentist or podiatrist to a licensed athletic trainer for athletic training services. An order may be written or oral, except that an oral order must be reduced to writing within 72 hours of issuance.

   Standing written prescription—A portion of the written protocol or a separate document from a supervising physician, which includes an order to treat approved individuals in accordance with the protocol.

   Written protocol—A written agreement or other document developed in conjunction with one or more supervising physicians, which identifies and is signed by the supervising physician and the licensed athletic trainer, and describes the manner and frequency in which the licensed athletic trainer regularly communicates with the supervising physician and includes standard operating procedures, developed in agreement with the supervising physician and licensed athletic trainer, that the licensed athletic trainer follows when not directly supervised onsite by the supervising physician.

§ 18.503. Licensure requirement.

 (a)  A person may not use the title ‘‘athletic trainer’’ or ‘‘licensed athletic trainer’’ or use any abbreviation including ‘‘A.T.,’’ ‘‘A.T.L.’’ or ‘‘L.A.T.’’ or any similar designation to indicate that the person is an athletic trainer unless that person has been licensed by the Board.

 (b)  Except as otherwise provided in this subsection, a person may not perform the duties of an athletic trainer unless that person is licensed by the Board. This provision is not intended to prevent the following:

   (1)  A person trained and licensed or certified under any other law from engaging in the licensed or certified practice in which the person is trained.

   (2)  An athletic trainer from another state, province, territory or the District of Columbia, who is employed by an athletic team or organization that is competing in this Commonwealth only on a visiting basis, from providing athletic training services, provided the practice of the athletic trainer is limited to the members of the team or organization.

   (3)  An athletic training student practicing athletic training that is coincidental to required clinical education and is within the scope of the student’s education and training.

 (c)  Athletic trainers licensed by the State Board of Osteopathic Medicine are deemed licensed by the Board.

§ 18.504. Application for licensure.

 (a)  The applicant shall submit the following on forms supplied by the Board:

   (1)  A completed application and the fee set forth in §  16.13 (relating to licensure, certification, examination and registration fees).

   (2)  Verification of professional education in athletic training in accordance with §  18.505 (relating to educational requirements).

   (3)  Documentation of passage of the National examination in accordance with §  18.506 (relating to examination requirement).

   (4)  Documentation of practice as an athletic trainer, if licensed or certified in another jurisdiction, and verification as to whether there has been disciplinary action taken in that jurisdiction.

   (5)  Verification of having completed at least 3 hours of approved training in child abuse recognition and reporting in accordance with §  16.108(a) (relating to child abuse recognition and reporting—mandatory training requirement).

 (b)  To qualify for licensure, an applicant shall be at least 20 years of age and may not be addicted to alcohol or hallucinogenic, narcotic or other drugs which tend to impair judgment or coordination.

Authority

   The provisions of this §  18.504 amended under section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.504 amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial pages (366380) to (366381).

§ 18.505. Educational requirements.

 An applicant for licensure shall comply with one of the following:

   (1)  Be a graduate of an approved athletic training education program.

   (2)  Hold and maintain current credentialing as a certified athletic trainer (ATC) from the BOC or another credentialing body approved by the Board.

Cross References

   This section cited in 49 Pa. Code §  18.504 (relating to application for licensure).

§ 18.506. Examination requirement.

 An applicant for a license to practice as a licensed athletic trainer shall submit to the Board written evidence that the applicant has passed the BOC examination for athletic trainers, or its equivalent as determined by the Board.

Cross References

   This section cited in 49 Pa. Code §  18.504 (relating to application for licensure).

§ 18.507. Temporary licensure.

 An applicant who is a graduate of an approved athletic training education program and who has applied to take the examination may be granted a temporary license to practice athletic training under the onsite direct supervision of a licensed athletic trainer. The temporary license expires 1 year from issuance or upon licensure as an athletic trainer by the Board, whichever comes first, and may not be renewed.

§ 18.508. Renewal of license.

 (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 and pay the required fee prior to the expiration of the next 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 as set forth in section 225 of the Bureau of Professional and Occupational Affairs Fee Act (63 P. S. §  1401-225).

 (e)  As a condition of renewal, a licensee shall comply with the continuing education requirements in §  18.511 (relating to continuing education).

§ 18.509. Practice standards for athletic trainers.

 (a)  Athletic trainers licensed by the Board or certified or licensed by the proper licensing authority of another state, province, territory or the District of Columbia shall comply with the following:

   (1)  Ensure that the physically active person has secured a written referral or prescription from a licensed physician, dentist or podiatrist or is subject to a written protocol for treatment by a licensed or certified athletic trainer from a licensed physician.

   (2)  Comply strictly with conditions or restrictions that may be placed on the course of athletic training services by the referring physician, dentist or podiatrist.

   (3)  Ensure that the physically active person has undergone a medical diagnostic examination or has had the results of a recently performed medical diagnostic examination reviewed by the referring physician, dentist or podiatrist.

   (4)  Keep a copy of the referral or prescription and the results of the medical diagnostic examination in the physically active person’s file.

   (5)  Consult promptly with the referring physician, dentist or podiatrist regarding a new ailment or condition or a worsened ailment or condition of the physically active person.

   (6)  Consult with the referring physician, dentist or podiatrist upon request of either the referring physician, dentist or podiatrist or the physically active person.

   (7)  Refer a physically active person with conditions outside the scope of athletic training services to a licensed physician, dentist or podiatrist.

 (b)  Athletic trainers licensed by the Board or certified or licensed by the proper licensing authority of another state, province, territory or the District of Columbia who are working in a team setting, treating injuries which arise in the course of practices or team sports events, may treat the participant at the events under the conditions of the referral, or the standing written prescription or written protocol.

 (c)  An athletic trainer shall obtain the standing written prescription or protocol annually from the supervising physician and review it at least annually. The standing written prescription or written protocol shall be retained at or near the treatment location or facility. An individual referral or prescription from a referring physician, dentist or podiatrist is required in the absence of a standing written prescription or written protocol.

§ 18.510. Refusal, suspension or revocation of license.

 (a)  The Board may refuse to issue a license, and after notice and hearing, may suspend or revoke the license of a person who is subject to disciplinary action under section 41 of the act (63 P. S. §  422.41) as set forth in §  16.61 (relating to unprofessional and immoral conduct).

 (b)  Actions taken by the Board regarding the refusal, suspension or revocation of a license are taken subject to the right of notice, hearing and adjudication and appeal under 2 Pa.C.S. § §  501—508 and 701—704 (relating to Administrative Agency Law).

§ 18.511. Continuing education.

 (a)  Beginning with the biennial period commencing on the next biennial renewal period following July 14, 2007, athletic trainers shall complete the continuing education requirements prescribed by the BOC.

 (a.1)  Applicants for renewal of a license shall, as a condition of biennial renewal, complete at least 2 hours of approved training in child abuse recognition and reporting in accordance with §  16.108(b) (relating to child abuse recognition and reporting—mandatory training requirement).

 (b)  Applicants for renewal of a license shall provide a signed statement verifying that the continuing education requirement has been met.

 (c)  Proof of completion of the required continuing education shall be retained for at least 2 years after completion.

Authority

   The provisions of this §  18.511 amended under section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.504 amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial page (366383).

Cross References

   This section cited in 49 Pa. Code §  18.508 (relating to renewal of license).

Subchapter I. BEHAVIOR SPECIALISTS


Sec.


18.521.    Purpose.
18.522.    Definitions.
18.523.    Application for licensure as behavior specialist.
18.524.    Criteria for licensure as behavior specialist.
18.525.    Renewal of licensure as behavior specialist.
18.526.    Inactive status of licensure as behavior specialist.
18.527.    Disciplinary action for licensed behavior specialist.

Authority

   The provisions of this Subchapter I issued under sections 8 and 25 of the Medical Practice Act of 1985 (63 P.S. § §  422.8 and 422.25) and under section 635.2(g) of The Insurance Company Law of 1921 (40 P.S. §  764h(g)).

Source

   The provisions of this Subchapter I adopted May 25, 2012, effective May 26, 2012, 42 Pa.B. 2955.

§ 18.521. Purpose.

 This subchapter implements section 635.2(g) of The Insurance Company Law of 1921 (40 P. S. §  764h(g)) to provide for the licensure of behavior specialists. To the extent that an individual holds a professional license whose scope of practice includes the diagnostic assessment or treatment of autism spectrum disorders, this subchapter is not intended to require dual licensure, impact the licensee’s scope of practice or impact the licensee’s ability to qualify as a participating provider.

§ 18.522. Definitions.

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

   Applied behavioral analysis—The design, implementation and evaluation of environmental modifications, using behavioral stimuli and consequences, to produce socially significant improvement in human behavior or to prevent loss of attained skill or function, which includes:

     (i)   The use of direct observation, measurement and functional analysis of the relations between environment and behavior.

     (ii)   The attempt to solve behavior challenges using evidence-based principles and practices of learning and behavior.

     (iii)   The analysis of the relationship between a stimulus, consequence or other variable as defined in this section. The changes of stimuli, consequences or other variables may occur individually, as a combination or in relationship with each other. The change of stimuli, consequences or other variables may be external or internal to the person whose behavior is being analyzed.

   Autism spectrum disorders—Any of the pervasive developmental neurobehavioral disorders defined by the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders, or its successor, including autistic disorder, Asperger’s disorder and pervasive developmental disorder not otherwise specified.

   BACB—The Behavior Analyst Certification Board.

   BAS—The Bureau of Autism Services of the Department of Public Welfare.

   Behavior challenges—Symptoms that include impairment in reciprocal social interaction, qualitative impairment in communication, the presence of internalizing or externalizing behaviors such as suicidal ideation, self-injurious behaviors, aggression, destructive or disruptive behaviors, isolation and social withdrawal, ritualistic repetitive and stereotypic patterns of behaviors, or extreme difficulty in adapting to change and transition.

   Behavior specialist—An individual who designs, implements or evaluates a behavior modification intervention component of a treatment plan, including those based on applied behavioral analysis, to produce socially significant improvements in human behavior or to prevent loss of attained skill or function, through skill acquisition and the reduction of problematic behavior.

   Consequence—A resulting directly measurable change of a person’s behavior produced by a change in a stimulus or stimuli.

   Diagnostic assessment of autism spectrum disorders—Medically necessary assessments, evaluations or tests performed by a licensed physician, licensed physician assistant, licensed psychologist or certified registered nurse practitioner to diagnose whether an individual has an autism spectrum disorder.

   Stimulus—An event, circumstance or condition that can be changed or does change based upon the behavior specialist’s manipulation.

   Treatment plan—A plan for the treatment of autism spectrum disorders developed by a licensed physician or psychologist pursuant to a comprehensive evaluation or reevaluation performed in a manner consistent with the most recent clinical report or recommendations of the American Academy of Pediatrics.

   Variables—An observed or manipulable condition which can be changed or does change and a directly measurable change of a person’s behavior produced by the change.

§ 18.523.  Application for licensure as behavior specialist.

 (a)  An applicant for licensure as a behavior specialist shall submit, on forms made available by the Board, a completed application, including all necessary supporting documents, for licensure as a behavior specialist and pay the fee in §  16.13(i) (relating to licensure, certification, examination and registration fees) for application for licensure as a behavior specialist.

   (1)  Among the supporting documents, the applicant shall submit, or cause to be submitted, to the Board:

     (i)   A criminal history record information report completed by the Pennsylvania State Police or the state police for each state in which the applicant currently resides or works and has resided or worked during the previous 10 years completed no more than 90 days prior to the date the application is received in the Board office.

     (ii)   A child abuse history clearance completed by the Department of Public Welfare or equivalent agency for each state in which the applicant currently resides or works and has resided or worked during the previous 10 years completed no more than 90 days prior to the date the application is received in the Board office.

     (iii)   A Federal Bureau of Investigation criminal justice information services criminal record completed no more than 90 days prior to the date the application is received in the Board office.

     (iv)   Verification of having completed at least 3 hours of approved training in child abuse recognition and reporting in accordance with §  16.108(a) (relating to child abuse recognition and reporting—mandatory training requirement).

   (2)  The applicant shall provide updates to documents in possession of the Board for more than 6 months while the application remains pending.

 (b)  Except as otherwise provided in subsections (c) and (d), the Board will license as a behavior specialist an applicant who demonstrates that the applicant satisfies the requirements of section 635.2(g)(2) of The Insurance Company Act of 1921 (40 P. S. §  764h(g)(2)) for registration as a behavior specialist, as provided in §  18.524 (relating to criteria for licensure as behavior specialist), and otherwise complies with this subchapter.

 (c)  The Board may deny an application for licensure as a behavior specialist upon the grounds for disciplinary action in §  18.527 (relating to disciplinary action for licensed behavior specialist).

 (d)  The Board will not grant an application for licensure as a behavior specialist of an applicant who:

   (1)  Has been convicted of a felony offense as provided in section 635.2(g)(3) of The Insurance Company Act of 1921 unless at least 10 years have elapsed from the date of conviction and the applicant has satisfactorily demonstrated to the Board that the applicant has made significant progress in personal rehabilitation since the conviction that licensure of the applicant should not be expected to create a substantial risk of harm to the health and safety of the applicant’s patients or the public or a substantial risk of further criminal violations.

   (2)  Has been convicted of, entered a plea of guilty to or adjudicated delinquent of a crime for which the applicant has been required to register under 42 Pa.C.S. Chapter 97, Subchapter H (relating to registration of sexual offenders), known as Megan’s Law, without regard to the time elapsed since the date of the conviction, plea or adjudication or the length of the registration required under Megan’s Law. As used in this paragraph, ‘‘convicted’’ includes a judgment, an admission of guilt or plea of nolo contendre.

   (3)  Has failed to satisfy the Board that the applicant is of good moral character.

Authority

   The provisions of this §  18.523 amended under section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.523 amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial pages (361227) to (361228).

§ 18.524. Criteria for licensure as behavior specialist.

 (a)  An applicant for licensure as a behavior specialist shall satisfy the Board that the applicant is of good moral character and has received a master’s or higher degree from a Board-approved, accredited college or university, including a major course of study in at least one of the following:

   (1)  School, clinical, developmental or counseling psychology.

   (2)  Special education.

   (3)  Social work.

   (4)  Speech therapy.

   (5)  Occupational therapy.

   (6)  Professional counseling.

   (7)  Behavioral analysis.

   (8)  Nursing.

   (9)  Another related field.

 (b)  An applicant for licensure as a behavior specialist shall have at least 1 year of experience involving functional behavior assessments of individuals under 21 years of age, including the development and implementation of behavioral supports or treatment plans.

 (c)  An applicant for licensure as a behavior specialist shall have completed at least 1,000 hours of in-person clinical experience with individuals with behavioral challenges or at least 1,000 hours of experience in a related field with individuals with autism spectrum disorders.

 (d)  An applicant for licensure as a behavior specialist shall have completed 90 hours of course work in evidence-based practices from an accredited college or university or training approved by the BACB or the BAS as follows:

   (1)  Three hours of professional ethics approved by the BAS.

   (2)  Eighteen hours of autism-specific coursework or training.

   (3)  Sixteen hours of assessments coursework or training.

   (4)  Sixteen hours of instructional strategies and best practices.

   (5)  Eight hours of crisis intervention.

   (6)  Eight hours of comorbidity and medications.

   (7)  Five hours of family collaboration.

   (8)  Sixteen hours of addressing specific skill deficits training.

 (e)  Coursework under this section may be attended face-to-face instructor-led or online distance education and include:

   (1)  Hours completed during a master’s degree, post-master’s certificate or higher program as noted in a course syllabus.

   (2)  BACB continuing education credits.

   (3)  BAS-approved training with associated tests and corresponding course evaluations.

Cross References

   This section cited in 49 Pa. Code §  18.523 (relating to application for licensure as behavior specialist); and 55 Pa. Code §  5240.81 (relating to staff qualifications for ABA services).

§ 18.525. Renewal of licensure as behavior specialist.

 (a)  A license issued under this subchapter expires on December 31 of the 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 address on file with the Board.

 (c)  To retain licensure as a behavior specialist, the licensee shall renew the license in the manner prescribed by the Board and pay the required biennial renewal fee specified in §  16.13(i) (relating to licensure, certification, examination and registration fees) prior to the expiration of the current biennium.

 (d)  To renew licensure as a behavior specialist, the licensee shall apply on forms made available by the Board, fully answer all questions and pay the current renewal fee specified in §  16.13(i).

 (e)  As a condition of biennial renewal, a licensee shall complete at least 2 hours of approved training in child abuse recognition and reporting in accordance with §  16.108(b) (relating to child abuse recognition and reporting—mandatory training requirement).

Authority

   The provisions of this §  18.525 amended under section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.525 amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial page (398561).

§ 18.526. Inactive status of licensure as behavior specialist.

 (a)  Licensure as a behavior specialist will become inactive upon either of the following:

   (1)  The licensee in writing affirmatively requests the Board to place the license on inactive status. Written confirmation of inactive status will be forwarded to the licensee.

   (2)  The licensee fails to renew the license by the expiration of the renewal period.

 (b)  To reactivate an inactive license, the licensee shall apply on forms made available by the Board, answer all questions fully and pay the current renewal fee, if not previously paid, and the reactivation application fee specified in §  16.13(i) (relating to licensure, certification, examination and registration fees).

§ 18.527. Disciplinary action for licensed behavior specialist.

 Under section 635.2(g)(1) of The Insurance Company Law of 1921 (40 P. S. §  764h(g)(1)), a licensed behavior specialist is subject to the disciplinary provisions applicable to medical doctors as set forth in the act. Following a final determination subject to the right of notice, hearing and adjudication and the right of appeal therefrom in accordance with 2 Pa.C.S. (relating to administrative law and procedure), the Board may impose any of the corrective actions of section 42 of the act (63 P. S. §  422.42) upon a licensed behavior specialist who commits any act for which the Board would be authorized to take disciplinary action against a medical doctor under section 41 of the act (63 P. S. §  422.41), including unprofessional or immoral conduct as defined in §  16.61 (relating to unprofessional and immoral conduct).

Cross References

   This section cited in 49 Pa. Code §  18.523 (relating to application for licensure as behavior specialist).

Subchapter J. PERFUSIONISTS


Sec.


18.601.    Purpose.
18.602.    Definitions.
18.603.    Application for perfusionist license.
18.604.    Application for temporary graduate perfusionist license.
18.605.    Application for temporary provisional perfusionist license.
18.606.    Registration of temporary emergency perfusionist service.
18.607.    Biennial registration of perfusionist license.
18.608.    Inactive and expired status of perfusionist license; reactivation of inactive or expired license.
18.609.    Disciplinary action for licensed perfusionists.
18.610.    Continuing education for licensed perfusionists.
18.611.    Professional liability insurance coverage for licensed perfusionists.

Authority

   The provisions of this Subchapter J issued under sections 8 and 13.3(c) of the Medical Practice Act of 1985 (63 P.S. § §  422.8 and 422.13c(c)), unless otherwise noted.

Source

   The provisions of this Subchapter J adopted August 2, 2013, effective August 3, 2013, 43 Pa.B. 4329, unless otherwise noted.

§ 18.601. Purpose.

 This subchapter implements section 13.3 of the act (63 P. S. §  422.13c), regarding perfusionists.

§ 18.602. Definitions.

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

   ABCP—The American Board of Cardiovascular Perfusion.

   Accredited perfusion program approved by the Board—A perfusion program accredited by a Nationally-recognized accrediting agency approved by the Board.

   CAAHEP—The Commission on Accreditation of Allied Health Education Programs.

   Extracorporeal circulation—The diversion of a patient’s blood through a heart-lung machine or similar device that assumes the functions of the patient’s heart, lungs, kidneys, liver or other organ.

   Hour of continuing education—At least 50 minutes of instruction, including relevant question and answer sessions, in an approved course of continuing education or an equivalent time that an online or correspondence course would be presented live.

   Nationally-recognized accrediting agency approved by the Board—CAAHEP or other organization for which the Board publishes notice that the organization is approved by the Board as an accrediting agency for perfusionist programs.

   Nationally-recognized certifying agency approved by the Board—ABCP or other organization for which the Board publishes notice that the organization is approved by the Board as a certifying agency for perfusionists.

   Out-of-State perfusionist—An individual who holds a current license as a perfusionist in another state, the District of Columbia or a territory of the United States or has obtained certification by a certifying agency approved by a Nationally-recognized accrediting agency.

   Perfusion—The functions necessary for the support, treatment, measurement or supplementation of the cardiovascular system or other organs, or a combination of those functions, and for ensuring the safe management of physiologic functions by monitoring and analyzing the parameters of the systems under the supervision of a physician licensed under the act or the Osteopathic Medical Practice Act (63 P. S. § §  271.1—271.18).

   Perfusionist—An individual who is licensed to practice perfusion by the Board or the State Board of Osteopathic Medicine.

   Ventricular assist device—

     (i)   A mechanical device used to partially or completely replace the function of a failing heart through connections to the heart and great vessels that may be located intracorporeally or extracorporeally.

     (ii)   The term includes a device that is placed intravascularly or extravascularly and provides support through direct means or through counterpulsation.

§ 18.603. Application for perfusionist license.

 (a)  An applicant for a license to practice as a perfusionist shall submit, or cause to be submitted, on forms made available by the Board, a completed application, including the necessary supporting documents, for a license to practice as a perfusionist and pay the fee in §  16.13(l) (relating to licensure, certification, examination and registration fees) for application for a perfusionist license.

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

   (1)  Demonstrates that the applicant holds a current certification by a certifying agency approved by a Nationally-recognized accrediting agency approved by the Board.

   (2)  Demonstrates that the applicant has graduated from an accredited perfusion program approved by the Board.

   (3)  Demonstrates that the applicant is at least 18 years of age and of good moral character.

   (4)  Demonstrates that the applicant has obtained professional liability insurance as required under section 13.3(k) of the act (63 P.S. §  422.13c(k)).

 (4.1)  Demonstrates that the applicant has completed at least 3 hours of approved training in child abuse recognition and reporting in accordance with §  16.108(a) (relating to child abuse recognition and reporting—mandatory training requirement).

   (5)  Otherwise complies with this subchapter.

 (c)  The Board may deny an application for licensure as a perfusionist upon the grounds for disciplinary action in §  18.609 (relating to disciplinary action for licensed perfusionists).

Authority

   The provisions of this §  18.603 amended under section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.603 amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial pages (367767) to (367768).

Cross References

   This section cited in 49 Pa. Code §  18.606 (relating to registration of temporary emergency perfusionist service).

§ 18.604. Application for temporary graduate perfusionist license.

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

 (b)  The Board may grant a temporary graduate perfusionist license, which authorizes the license holder to practice only under the supervision and direction of a perfusionist licensed under the act, to an applicant who:

   (1)  Demonstrates that the applicant is eligible for and has applied to sit for the examination of a certifying agency approved by a Nationally-recognized accrediting agency approved by the Board.

   (2)  Demonstrates that the applicant has graduated from an accredited perfusion program approved by the Board.

   (3)  Demonstrates that the applicant is at least 18 years of age and of good moral character.

   (4)  Demonstrates that the applicant has obtained professional liability insurance as required under section 13.3(k) of the act (63 P.S. §  422.13c(k)).

   (5)  Otherwise complies with this subchapter.

 (c)  The Board may deny an application for a temporary graduate perfusionist license upon the grounds for disciplinary action in §  18.609 (relating to disciplinary action for licensed perfusionists).

 (d)  A temporary graduate perfusionist license expires 2 years after the date of the issuance and may not be renewed.

 (e)  [Reserved].

Authority

   The provisions of this §  18.604 amended under sections 8 and 13.3(h)(1) of the Medical Practice Act of 1985 (63 P.S. § §  422.8 and 422.13c(h)(1)).

Source

   The provisions of this §  18.604 amended June 2, 2023, effective June 3, 2023, 53 Pa.B. 2961. Immediately preceding text appears at serial pages (409217) to (409218).

Cross References

   This section cited in 49 Pa. Code §  18.606 (relating to registration of temporary emergency perfusionist service).

§ 18.605. Application for temporary provisional perfusionist license.

 (a)  An applicant for a temporary provisional perfusionist license shall submit, on forms made available by the Board, a completed application, including the necessary supporting documents, and pay the fee in §  16.13(l) (relating to licensure, certification, examination and registration fees) for application for a temporary provisional perfusionist license.

 (b)  The Board may grant a temporary provisional perfusionist license to an applicant who:

   (1)  Demonstrates that the applicant holds a current license in good standing under the laws of another state, the District of Columbia or a territory of the United States that includes certification by a certifying agency approved by a Nationally-recognized accrediting agency.

   (2)  Demonstrates that the applicant has graduated from an accredited perfusion program approved by the Board.

   (3)  Demonstrates that the applicant is at least 18 years of age and of good moral character.

   (4)  Demonstrates that the applicant has obtained professional liability insurance as required under section 13.3(k) of the act (63 P. S. §  422.13c(k)).

   (5)  Otherwise complies with this subchapter.

 (c)  The Board may deny an application for temporary provisional perfusionist licensure upon the grounds for disciplinary action in §  18.609 (relating to disciplinary action for licensed perfusionists).

 (d)  A temporary provisional perfusionist license expires 1 year after the date of issuance and may not be renewed.

Cross References

   This section cited in 49 Pa. Code §  18.606 (relating to registration of temporary emergency perfusionist service).

§ 18.606. Registration of temporary emergency perfusionist service.

 (a)  An out-of-State perfusionist shall register with the Board prior to providing temporary emergency perfusionist service in this Commonwealth in accordance with section 13.3(j) of the act (63 P. S. §  422.13c(j)).

 (b)  The out-of-State perfusionist or another person acting on behalf of the out-of-State perfusionist shall submit, on forms made available by the Board, a completed registration form with the questions fully answered which shall be verified by the out-of-State perfusionist by personal or electronic signature. The completed registration form shall be submitted by electronic means, including computer-to-computer, computer-to-facsimile machine or e-mail transmission.

 (c)  Although not limited to a single procedure or single patient or group of related patients, an out-of-State perfusionist may provide temporary emergency perfusionist services in this Commonwealth for no longer than 72 hours.

 (d)  An out-of-State perfusionist may not provide temporary emergency perfusionist service in this Commonwealth more than once without being licensed in accordance with §  18.603, §  18.604 or §  18.605 (relating to application for perfusionist license; application for temporary graduate perfusionist license; and application for temporary provisional perfusionist license).

 (e)  A registration for an out-of-State perfusionist is not complete unless the health care facility licensed by the Department of Health has submitted the certification required under section 13.3(j)(1)(ii) of the act to the Board by electronic means, including computer-to-computer, computer-to-facsimile machine or e-mail transmission.

§ 18.607. Biennial registration of perfusionist license.

 (a)  The license of a perfusionist expires biennially on December 31 of each even-numbered year in accordance with §  16.15 (relating to biennial registration; inactive status and unregistered status). A perfusionist may not practice after December 31 of an even-numbered year unless the perfusionist has completed the biennial registration process and the Board has issued a renewed registration.

 (b)  As a condition of biennial registration, a perfusionist shall:

   (1)  Submit a completed application, including payment of the biennial registration fee in §  16.13(l) (relating to licensure, certification, examination and registration fees), for application for biennial registration of a perfusionist license.

   (2)  Disclose on the application a license to practice as a perfusionist in another state, district, territory, possession or country.

   (3)  Disclose on the application disciplinary action pending before or taken by the appropriate health care licensing authority in another jurisdiction since the most recent application for biennial registration, whether or not licensed to practice in that other jurisdiction.

   (4)  Disclose on the application pending criminal charges and a finding or verdict of guilt, admission of guilt, plea of nolo contendere, probation without verdict, disposition instead of trial or accelerated rehabilitative disposition in a criminal matter since the most recent application for biennial registration.

   (5)  Verify on the application that the licensed perfusionist has complied with the continuing education requirements mandated under section 13.3(n) of the act (63 P. S. §  422.13c(n)) during the biennial period immediately preceding the period for which registration is sought in accordance with §  18.610 (relating to continuing education for licensed perfusionists).

   (6)  Verify on the application that, if practicing as a perfusionist in this Commonwealth, the licensee maintains professional liability insurance coverage in accordance with section 13.3(k) of the act.

§ 18.608. Inactive and expired status of perfusionist license; reactivation of inactive or expired license.

 (a)  A perfusionist license will become inactive if the licensee requests in writing that the Board place the license on inactive status. The Board will provide written confirmation of inactive status to the licensee at the licensee’s last known address on file with the Board.

 (b)  A perfusionist license will be classified as expired if the licensee fails to register the license by the expiration of the biennial registration period on December 31 of each even-numbered year. The Board will provide written notice to a licensee who fails to make biennial registration by sending a notice to the licensee’s last known address on file with the Board.

 (c)  A perfusionist whose license has become inactive or expired may not practice as a perfusionist in this Commonwealth until the license has been reactivated.

 (d)  To reactivate an inactive or expired license, the licensee shall apply on forms made available by the Board and fully answer the questions. The licensee shall:

   (1)  Include the documentation required under §  18.610(b) (relating to continuing education for licensed perfusionists) for the immediately preceding biennium, which may be completed during the current biennium. Unless waived by the Board under section 13.3(n)(4) of the act (63 P. S. §  422.13c(n)(4)), the Board will not reactivate a license until the required continuing education for the preceding biennium has been successfully completed.

   (2)  Pay the current biennial registration fee and the reactivation application fee in §  16.13(l) (relating to licensure, certification, examination and registration fees).

   (3)  Verify that the licensee did not practice as a perfusionist in this Commonwealth while the license was inactive or expired except as provided in subsection (e).

 (e)  A licensee who has practiced with an inactive or expired license and who cannot make the verification required under subsection (d)(3) shall also pay the fees required under this subsection. Payment of a late fee does not preclude the Board from taking disciplinary action for practicing as a perfusionist without a currently registered license.

   (1)  A licensee whose license was active at the end of the immediately preceding biennial registration period and who practiced after the license became inactive or expired shall pay a late fee of $5 for each month or part of a month from the beginning of the current biennium until the date the reactivation application is filed.

   (2)  A licensee whose license has been inactive or expired since before the beginning of the current biennium shall pay the biennial registration fee for each biennial registration period during which the licensee practiced and shall pay a late fee of $5 for each month or part of a month from the first date the licensee practiced as a perfusionist in this Commonwealth after the license became inactive or expired until the date the reactivation application is filed.

§ 18.609. Disciplinary action for licensed perfusionists.

 (a)  A licensed perfusionist, including a perfusionist holding a temporary graduate license or a temporary provisional license, is subject to disciplinary action under section 41 of the act (63 P. S. §  422.41). Following a final determination subject to the right of notice, hearing and adjudication and the right of appeal in accordance with 2 Pa.C.S. § §  501—508 and 701—704 (relating to Administrative Agency Law), the Board may impose a corrective action in section 42 of the act (63 P. S. §  422.42).

 (b)  Unprofessional conduct includes:

   (1)  Engaging in conduct prohibited under §  16.110 (relating to sexual misconduct).

   (2)  Performing an act in a health care profession in a fraudulent, incompetent or negligent manner.

   (3)  Violating a provision of the act or this chapter setting a standard of professional conduct.

   (4)  Engaging in health care practice beyond the licensee’s authority to practice.

   (5)  Representing oneself to be a physician, physician assistant, certified registered nurse practitioner or other health care practitioner whose profession the perfusionist is not licensed to practice.

   (6)  Practicing while the licensee’s ability to do so is impaired by alcohol, drugs, physical disability or mental instability.

   (7)  Revealing personally identifiable facts obtained as the result of a practitioner-patient relationship without the prior consent of the patient, except as authorized or required under statute or regulation.

   (8)  Failing to provide supervision as required under section 13.3(e)(2) of the act (63 P. S. §  422.13c(e)(2)) of a perfusion student or failing to provide supervision as required under section 13.3(e)(3) of the act of a perfusion graduate who is not otherwise licensed by the Board to perform perfusion in this Commonwealth.

 (c)  Immoral conduct includes:

   (1)  Misrepresenting or concealing a material fact in obtaining a license issued by the Board or renewal, reactivation or reinstatement thereof.

   (2)  Being convicted of a crime involving moral turpitude, dishonesty or corruption in the courts of the Commonwealth, the United States, another state, the District of Columbia, a territory of the United States or another country.

   (3)  Committing an act involving moral turpitude, dishonesty or corruption.

Cross References

   This section cited in 49 Pa. Code §  18.603 (relating to application for perfusionist license); 49 Pa. Code §  18.604 (relating to application for temporary graduate perfusionist license); and 49 Pa. Code §  18.605 (relating to application for temporary provisional perfusionist license).

§ 18.610. Continuing education for licensed perfusionists.

 (a)  Credit hour requirements. A licensed perfusionist shall satisfy the following continuing education credit hour requirements.

   (1)  As a condition for biennial registration, a licensee shall complete at least 30 hours of continuing education applicable to the practice of perfusion, including at least 10 hours of category I continuing education, and at least 2 hours of approved training in child abuse recognition and reporting in accordance with §  16.108(b) (relating to child abuse recognition and reporting—mandatory training requirement). A licensee is not required to complete continuing education during the biennium in which the licensee is first licensed.

   (2)  Except when reactivating an inactive license, when the Board has granted a waiver or when ordered by the Board, continuing education credits may be used to satisfy the continuing education credit hour requirements only for the biennial period in which the credits were earned. An hour of continuing education may not be used to satisfy the requirement of paragraph (1) for more than 1 biennium.

   (3)  A licensee may request a waiver of the continuing education credit hour requirements because of serious illness, military service or other demonstrated hardship by submitting a request for waiver with supporting documentation to the Board at least 90 days prior to the end of the biennial registration period for which the waiver is sought. The Board may grant the waiver request in whole or in part and may extend the deadline by which the credit hour requirements shall be met.

   (4)  A licensee may be subject to disciplinary sanction as provided in section 41 of the act (63 P. S. §  422.41), including the suspension or revocation of the license, imposition of a civil penalty or other corrective measure as determined by the Board if the licensee either submits false information to the Board regarding completion of the continuing education credit hour requirements to complete biennial registration or fails to complete the continuing education hour requirements and practices as a perfusionist after the end of the biennial period.

 (b)  Documentation of continuing education. Continuing education shall be documented in the following manner.

   (1)  Proof of attendance at an ABCP-approved perfusion meeting consists of a certified record issued by the provider, including:

     (i)   The name of the participant.

     (ii)   The name of the provider.

     (iii)   The date or dates of the course.

     (iv)   The name of the course.

     (v)   The number of hours of continuing education credit.

   (2)  Proof of a perfusion-related publication consists of the complete citation reference to the book, chapter or paper in a professional publication.

   (3)  Proof of presentation at an ABCP-approved or international perfusion meeting consists of a copy of the program agenda.

   (4)  Proof of participation in an ABCP knowledge base survey consists of a letter from ABCP.

   (5)  Proof of reading or viewing medical journals, audio-visual or other educational materials consists of a list of the complete citation reference for the materials read or reviewed.

   (6)  Proof of participation in a perfusion-related self-study module or electronic forum consists of a copy of the printed completion document supplied by the provider.

   (7)  Proof of participation in a perfusion-related journal club consists of the meeting agenda with topic and date.

   (8)  Proof of completion of an academic course consists of a copy of the official college or university transcript.

   (9)  Proof of presentation of a perfusion topic at a meeting that is not approved by ABCP consists of a copy of the meeting agenda.

   (10)  Proof of participation as a clinical or didactic instructor in an accredited program consists of a letter of confirmation of the instructor’s status from the program director.

   (11)  Proof of participation in a site visitors’ workshop or as an official site visitor consists of a letter from ABCP.

 (c)  Proof of completion of continuing education. A licensee shall retain proof of completion of continuing education for 5 years after completion of the continuing education or after the completion of the biennial registration period for which the continuing education was required, whichever is later.

 (d)  Verification of compliance. The Board may audit licensees to verify compliance with continuing education requirements. A licensee shall submit proof of continuing education activities upon request by the Board.

 (e)  Continuing education activities. Credit for continuing education may be earned in the following activities.

   (1)  Category I continuing education may be earned by:

     (i)   Attendance at an ABCP-approved perfusion meeting. One continuing education credit may be earned for each hour of continuing education.

     (ii)   Publication of a perfusion-related book, chapter or paper in a professional publication. Five continuing education credits may be earned for each publication.

     (iii)   Presentation at an ABCP-approved or international, National, regional, state or local perfusion meeting. Five continuing education credits may be earned for each presentation. Two credits may be earned for each poster presentation or exhibit.

     (iv)   Completion of an ABCP knowledge base survey. Five continuing education hours may be earned for completing the continuing education activity. The activity may only be counted for credit once in a biennial period.

   (2)  In addition to category I, continuing education may also be earned by:

     (i)   Reading or viewing medical journals, audio-visual or other educational materials. One continuing education credit may be earned for each medical journal, audio-visual or other educational material read or viewed with a maximum of ten credits biennially.

     (ii)   Participation in perfusion-related self-study modules or electronic forums. One continuing education credit may be earned for each 50- to 60-minute period of the activity with a maximum of ten credits biennially.

     (iii)   Participation in a perfusion-related journal club. One continuing education credit may be earned for each 50- to 60-minute period of the activity, with a maximum of ten credits biennially.

     (iv)   Completion of a science or health care-related academic course at a regionally accredited college or university. One continuing education credit may be earned biennially.

     (v)   Presentation of a perfusion topic at a meeting that is not approved by ABCP. One continuing education credit may be earned biennially.

     (vi)   Working as a clinical or didactic instructor in an accredited school of perfusion. Two continuing education credits may be earned for teaching a single course with a maximum of four credits biennially.

     (vii)   Participation in a site visitors’ workshop or as an official site visitor for perfusion program accreditation. Five continuing education credits may be earned for participation in a site visitor’s workshop or as an official site visitor for perfusion program accreditation. The activity may only be counted for credit once in a biennial period.

   (3)  Continuing education credit may not be earned in a course in office management.

Authority

   The provisions of this §  18.610 amended under section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.610 amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial pages (367772) to (367774) and (373951).

Cross References

   This section cited in 49 Pa. Code §  18.607 (relating to biennial registration of perfusionist license); and 49 Pa. Code §  18.608 (relating to inactivate and expired status of perfusionist license; reactivation of inactive or expired license).

§ 18.611. Professional liability insurance coverage for licensed perfusionists.

 (a)  A licensed perfusionist shall maintain a level of professional liability insurance coverage as required under section 13.3(k) of the act (63 P. S. §  422.13c(k)).

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

   (1)  A certificate of insurance or copy of the declaration page from the 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 13.3(k)(2) of the act will become inactive as a matter of law 30 days after the date of 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 13.3(k) of the act may not practice as a perfusionist in this Commonwealth.

Subchapter K. GENETIC COUNSELORS


Sec.


18.701.    Purpose.
18.702.    Definitions.
18.703.    Application for genetic counselor license.
18.704.    Application for genetic counselor license by uncertified persons.
18.705.    Application for temporary provisional genetic counselor license.
18.706.    Biennial registration of genetic counselor license.
18.707.    Inactive status of genetic counselor license; reactivation of inactive license.
18.708.    Disciplinary action for applicants and genetic counselors.
18.709.    Continuing education for genetic counselors.
18.710.    Professional liability insurance coverage for genetic counselors.

Authority

   The provisions of this Subchapter K issued under sections 3, 8 and 13.4 of the Medical Practice Act of 1985 (63 P.S. § §  422.8 and 422.13d); and the act of December 22, 2011 (P.L. 576, No. 125), unless otherwise noted.

Source

   The provisions of this Subchapter K adopted October 31, 2014, effective November 1, 2014, 44 Pa.B. 6923, unless otherwise noted.

§ 18.701. Purpose.

 This subchapter implements section 13.4 of the act (63 P. S. §  422.13d), regarding genetic counselors.

§ 18.702. Definitions.

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

   ABGC—The American Board of Genetic Counseling or an equivalent successor.

   ABMG—The American Board of Medical Genetics or an equivalent successor.

   Active candidate status—The designation awarded to an individual who has received approval from the ABGC or the ABMG to sit for the respective certification examination.

   Genetic counseling—The provision of services to individuals, couples, families and organizations by one or more appropriately trained individuals to address the physical and psychological issues associated with the occurrence or risk of occurrence of a genetic disorder, birth defect or genetically influenced condition or disease in an individual or a family.

   Genetic counselor—An individual who is licensed to practice genetic counseling by the Board or the State Board of Osteopathic Medicine.

   Graduate genetic counselor—An individual who has been issued a temporary provisional genetic counselor license by the Board under §  18.705 (relating to application for temporary provisional genetic counselor license) to practice under the supervision of a physician or genetic counselor.

   Hour of continuing education—At least 50 minutes of instruction, including relevant question and answer sessions, in an approved course of continuing education or an equivalent time that an online or correspondence course would be presented live.

   NSGC—The National Society of Genetic Counselors or an equivalent successor.

§ 18.703. Application for genetic counselor license.

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

 (b)  The Board may issue a license to practice as a genetic counselor to an applicant who demonstrates that the applicant:

   (1)  Is at least 21 years of age and of good moral character, as required under section 13.4(e)(1) and (2) of the act (63 P.S. §  422.13d(e)(1) and (2)).

   (2)  Has received a master’s degree or doctoral degree in human genetics or genetic counseling from an ABGC-accredited or ABMG-accredited educational program or has met the requirements for certification by the ABGC or the ABMG. Proof of the degree, if applicable, shall be sent directly from the applicant’s education program and include an official transcript.

   (3)  Has passed the examination for certification as a genetic counselor by the ABGC or the ABMG or has passed the examination for certification as a Ph.D. medical geneticist by the ABMG. Proof that the applicant has passed the examination shall be sent directly from the ABGC or the ABMG, and may include proof of current certification.

   (4)  Has obtained professional liability insurance, or is exempt from the requirement to obtain professional liability insurance, as set forth in §  18.710 (relating to professional liability insurance coverage for genetic counselors).

   (5)  Has completed at least 3 hours of approved training in child abuse recognition and reporting in accordance with §  16.108(a) (relating to child abuse recognition and reporting—mandatory training requirement).

 (c)  The Board may deny an application for licensure as a genetic counselor upon the grounds for disciplinary action in §  18.708 (relating to disciplinary action for applicants and genetic counselors).

Authority

   The provisions of this §  18.703 amended under section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.703 amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial pages (373952) to (373953).

Cross References

   This section cited in 49 Pa. Code §  18.705 (relating to application for temporary provisional genetic counselor license).

§ 18.704. Application for genetic counselor license by uncertified persons.

 (a)  An applicant for a license to practice as a genetic counselor who has never passed the ABGC or ABMG certification examination shall submit, on forms made available by the Board, a completed application for a license to practice as a genetic counselor, including the necessary supporting documents, and pay the application fee in §  16.13(m) (relating to licensure, certification, examination and registration fees).

 (b)  The Board may issue a license to practice as a genetic counselor to an uncertified applicant who:

   (1)  Submits an application to the Board, along with the required supporting documentation, by February 20, 2015.

   (2)  Demonstrates that the applicant is at least 21 years of age and of good moral character as required under section 13.4(e)(1) and (2) of the act (63 P. S. §  422.13d(e)(1) and (2)).

   (3)  Demonstrates that the applicant has received a master’s degree or higher in genetics or a related field of study and has worked as a genetic counselor for a minimum of 3 continuous years preceding December 22, 2011, or has received a bachelor’s degree in genetics or a related field of study and has been employed as a genetic counselor for at least 10 continuous years prior to December 22, 2011.

     (i)   Proof of the degree shall be sent directly from the applicant’s educational program and include an official transcript.

     (ii)   Related fields of study must include core courses in genetics.

     (iii)   Proof of employment as a genetic counselor may include Federal income tax forms or notarized letters from the applicant’s employers.

   (4)  Submits at least three letters of recommendation, including one from a genetic counselor certified by the ABGC or the ABMG and one from either a clinical geneticist or medical geneticist certified by the ABMG. A person who submits a letter of recommendation shall have worked with the applicant in an employment setting sometime during the previous 10 continuous years and be able to attest to the applicant’s competency in providing genetic counseling services.

   (5)  Demonstrates that the applicant has obtained professional liability insurance, or is exempt from the requirement to obtain professional liability insurance, as set forth in §  18.710 (relating to professional liability insurance coverage for genetic counselors).

   (6)  Demonstrates that the applicant has completed at least 3 hours of approved training in child abuse recognition and reporting in accordance with §  16.108(a) (relating to child abuse recognition and reporting—mandatory training requirement).

Authority

   The provisions of this §  18.704 amended under section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.704 amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial pages (373953) to (373954).

§ 18.705. Application for temporary provisional genetic counselor license.

 (a)  An applicant for a temporary provisional genetic counselor license shall submit, on forms made available by the Board, a completed application, including the necessary supporting documents, and pay the fee in §  16.13(m) (relating to licensure, certification, examination and registration fees) for an application for a temporary provisional genetic counselor license.

 (b)  The Board may grant a temporary provisional genetic counselor license, which authorizes the license holder to practice only under the supervision of a genetic counselor or physician licensed under the act or under the Osteopathic Medical Practice Act (63 P. S. § §  271.1—271.18), to an applicant who:

   (1)  Demonstrates that the applicant has been granted active candidate status establishing eligibility to sit for the next available certification examination offered by the ABGC.

   (2)  Demonstrates that the applicant is at least 21 years of age, of good moral character and has completed an application form provided by the Board.

   (3)  Otherwise complies with this subchapter.

 (c)  The Board may deny an application for a temporary provisional genetic counselor license upon the grounds in §  18.708 (relating to disciplinary action for applicants and genetic counselors).

 (d)  A temporary provisional genetic counselor license will expire upon the close of the second examination period for which the holder is eligible to test following the date of issuance of the temporary provisional license and may not be renewed.

 (e)  A temporary provisional genetic counselor license will expire upon notice to the Board that the holder has not passed the certification examination within two examination cycles after receiving the temporary provisional license. The holder of a temporary provisional genetic counselor license who fails to pass the examination within two examination cycles shall immediately cease practicing and return the license to the Board. An individual whose temporary provisional genetic counselor license has expired under subsection (d) or this subsection may apply for a genetic counselor license when the individual can demonstrate the qualifications in §  18.703 (relating to application for genetic counselor license).

 (f)  The holder of a temporary provisional genetic counselor license may not use the title ‘‘genetic counselor.’’ The holder of a temporary provisional genetic counselor license may use the title ‘‘graduate genetic counselor’’ but may not use an abbreviation of the title.

 (g)  A graduate genetic counselor shall inform clients that the graduate genetic counselor holds a temporary provisional license and practices under supervision.

Cross References

   This section cited in 49 Pa. Code §  18.702 (relating to definitions).

§ 18.706. Biennial registration of genetic counselor license.

 (a)  The license of a genetic counselor will expire biennially on December 31 of each even-numbered year in accordance with §  16.15 (relating to biennial registration; inactive status and unregistered status). A genetic counselor may not practice after December 31 of an even-numbered year unless the genetic counselor has completed the biennial renewal process and the Board has issued a renewed license.

 (b)  As a condition of biennial renewal, a genetic counselor shall:

   (1)  Submit a completed application, including payment of the biennial registration fee in §  16.13(m) (relating to licensure, certification, examination and registration fees) for application for biennial registration of genetic counselor license.

   (2)  Disclose on the application a license to practice as a genetic counselor in another state, district, territory, possession or country.

   (3)  Disclose on the application disciplinary action pending before or taken by the appropriate health care licensing authority in another jurisdiction since the most recent application for biennial registration, whether or not licensed to practice in that other jurisdiction.

   (4)  Disclose on the application pending criminal charges and a finding or verdict of guilt, admission of guilt, plea of nolo contendere, probation without verdict, disposition instead of trial or accelerated rehabilitative disposition in any criminal matter since the most recent application for biennial registration.

   (5)  Verify on the application that the genetic counselor has complied with the continuing education requirements mandated by section 13.4(j) of the act (63 P. S. §  422.13d(j)) during the biennial period immediately preceding the period for which registration is sought in accordance with §  18.709 (relating to continuing education for genetic counselors).

   (6)  Verify on the application that, if practicing as a genetic counselor in this Commonwealth, the licensee maintains professional liability insurance coverage in accordance with §  18.710 (relating to professional liability insurance coverage for genetic counselors).

§ 18.707. Inactive status of genetic counselor license; reactivation of inactive license.

 (a)  A genetic counselor license will become inactive upon either of the following:

   (1)  The licensee requests in writing that the Board place the license on inactive status. Written confirmation of inactive status will be forwarded to the licensee.

   (2)  The licensee fails to register the license by the expiration of the biennial registration period, that is, by December 31 of each even-numbered year.

 (b)  A genetic counselor whose license has become inactive may not practice as a genetic counselor in this Commonwealth until the license has been reactivated.

 (c)  To reactivate an inactive license, the licensee shall apply on forms made available by the Board. The licensee shall:

   (1)  Include the documentation required under §  18.709 (relating to continuing education for genetic counselors) for the immediately preceding biennium. Unless waived by the Board under section 13.4(j)(3) of the act (63 P. S. §  422.13d(j)(3)), the Board will not reactivate a license until the required continuing education for the preceding biennium has been successfully completed.

   (2)  Pay the current biennial registration fee and the reactivation application fee specified in §  16.13(m) (relating to licensure, certification, examination and registration fees).

   (3)  Except as provided in subsection (d), verify that the licensee did not practice as a genetic counselor in this Commonwealth while the license was inactive.

 (d)  A licensee whose license has been inactive for 4 years or more shall demonstrate continued competence by showing current certification by the ABGC.

 (e)  A licensee who has practiced with an inactive license, and who cannot make the verification required under subsection (c)(3), shall also pay the late fees required under section 225 of the Bureau of Professional and Occupational Affairs Fee Act (63 P. S. §  1401-225) as more fully set forth in this subsection. Payment of a late fee does not preclude the Board from taking disciplinary action for practicing as a genetic counselor without a currently registered license.

   (1)  A licensee whose license was active at the end of the immediately preceding biennial registration period and who practiced after the license became inactive shall pay a late fee of $5 for each month or part of a month from the beginning of the current biennium until the date the reactivation application is filed.

   (2)  A licensee whose license has been inactive since before the beginning of the current biennium shall pay the biennial registration fee for each biennial registration period during which the licensee practiced and shall pay a late fee of $5 for each month or part of a month from the first date the licensee practiced as a genetic counselor in this Commonwealth after the license became inactive until the date the reactivation application is filed.

§ 18.708. Disciplinary action for applicants and genetic counselors.

 (a)  A genetic counselor, graduate genetic counselor or applicant for a license under this subchapter is subject to refusal of license or disciplinary action under sections 22 and 41 of the act (63 P. S. § §  422.22 and 422.41). Following a final determination subject to the right of notice, hearing and adjudication and the right of appeal therefrom in accordance with 2 Pa.C.S. § §  501—508 and 701—704 (relating to Administrative Agency Law), the Board may refuse licensure or impose any of the corrective actions of section 42 of the act (63 P. S. §  422.42).

 (b)  A genetic counselor, graduate genetic counselor or applicant for licensure is subject to discipline under section 41(6) and (8) of the act for violating the provisions of this chapter and Chapter 16 (relating to State Board of Medicine—general provisions) or for being guilty of immoral or unprofessional conduct. Unprofessional conduct includes the conduct in §  16.61(a) (relating to unprofessional and immoral conduct) and, for purposes of this subchapter, also includes:

   (1)  Engaging in conduct prohibited under §  16.110 (relating to sexual misconduct).

   (2)  Performing an act in a health care profession in a fraudulent, incompetent or negligent manner.

   (3)  Violating a provision of the act or this subchapter setting a standard of professional conduct.

   (4)  Engaging in health care practice beyond the licensee’s authority to practice.

   (5)  Representing oneself to be a physician or other health care practitioner whose profession the genetic counselor is not licensed to practice.

   (6)  Practicing while the licensee’s ability to do so is impaired by alcohol, drugs, physical disability or mental instability.

   (7)  Revealing personally identifiable facts obtained as the result of a practitioner-patient relationship without the prior consent of the patient, except as authorized or required by statute or regulation.

   (8)  Failing to provide appropriate supervision to a genetic counselor student or a graduate genetic counselor practicing under a temporary provisional license. For purposes of this paragraph, appropriate supervision of a genetic counselor student means that the student is under the overall direction of the chair or director of the educational program. For purposes of this paragraph, appropriate supervision of a graduate genetic counselor means that the graduate genetic counselor is under the overall direction of the area supervisor and the supervisor conducts periodic review of the work of the graduate genetic counselor.

   (9)  Practicing outside the scope of practice for a genetic counselor as set forth in section 13.4(c) of the act (63 P. S. §  422.13d(c)).

   (10)  Failing to inform a client that a graduate genetic counselor holds a temporary provisional license and practices under supervision.

 (c)  Immoral conduct includes the conduct in §  16.61(b) and; for purposes of this subchapter, also includes:

   (1)  Misrepresenting or concealing a material fact in obtaining a license issued by the Board or renewal, reactivation or reinstatement thereof.

   (2)  Being convicted of a crime involving moral turpitude, dishonesty or corruption in the courts of the Commonwealth, the United States, another state, the District of Columbia, a territory of the United States or another country.

   (3)  Committing an act involving moral turpitude, dishonesty or corruption.

Cross References

   This section cited in 49 Pa. Code §  18.703 (relating to application for genetic counselor license); and 49 Pa. Code §  18.705 (relating to application for temporary provisional genetic counselor license).

§ 18.709. Continuing education for genetic counselors.

 (a)  Credit hour requirements. A genetic counselor shall satisfy the following continuing education credit hour requirements:

   (1)  As a condition for biennial registration, a genetic counselor shall complete at least 30 hours of continuing education applicable to the practice of genetic counseling, including at least 2 hours of approved training in child abuse recognition and reporting in accordance with §  16.108(b) (relating to child abuse recognition and reporting—mandatory training requirement). Credit will not be given for a course in office management or practice building. A genetic counselor is not required to complete continuing education during the biennium in which the genetic counselor was first licensed if licensure occurred within 3 years of completion of the degree.

   (2)  Except when reactivating an inactive license, when the Board has granted a waiver, or when ordered by the Board, continuing education credits may be used to satisfy the continuing education credit hour requirements only for the biennial period in which the credits were earned. An hour of continuing education may not be used to satisfy the requirement of paragraph (1) for more than one biennium.

   (3)  A genetic counselor may request a waiver of the continuing education credit hour requirements because of serious illness, military service or other demonstrated hardship by submitting a request for waiver with the supporting documentation to the Board at least 90 days prior to the end of the biennial registration period for which the waiver is sought. The Board may grant the waiver request in whole or in part and may extend the deadline by which the credit hour requirements shall be met.

   (4)  A genetic counselor may be subject to disciplinary sanction as provided in section 41 of the act (63 P. S. §  422.41), including the suspension or revocation of the license, imposition of a civil penalty or other corrective measure as determined by the Board, if the licensee either submits false information to the Board regarding completion of the continuing education credit hour requirements to complete biennial registration, or fails to complete the continuing education hour requirements and practices as a genetic counselor after the end of the biennial period.

 (b)  Continuing education activities. Credit for continuing education may be earned for activities approved by the ABGC or the NSGC.

 (c)  Documentation of continuing education. Continuing education shall be documented with a certificate of attendance or completion issued by the activity provider. The certificate must include the name of the course provider, the name and date of the course, the name of the licensee, the number of credit hours based on a 50-minute hour, and the category of continuing education, if applicable.

Authority

   The provisions of this §  18.709 amended under section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.709 amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial pages (373957) to (373958).

Cross References

   This section cited in 49 Pa. Code §  18.706 (relating to biennial registration of genetic counselor license); and 49 Pa. Code §  18.707 (relating to inactive status of genetic counselor license; reactivation of inactive license).

§ 18.710. Professional liability insurance coverage for genetic counselors.

 (a)  A genetic counselor practicing in this Commonwealth shall maintain a level of professional liability insurance coverage in the minimum amount of $1 million per occurrence or claims made as required under section 13.4(k) of the act (63 P. S. §  422.13d(k)).

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

   (1)  A certificate of insurance or copy of the declaration page from the insurance policy setting forth the effective date, expiration date and dollar amounts of coverage. The policy may be personally purchased liability insurance or professional liability insurance coverage provided by the genetic counselor’s employer.

   (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 13.4(k)(2) of the act will become inactive as a matter of law 30 days after the date of 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 13.4(k) of the act may not practice as a genetic counselor in this Commonwealth.

Cross References

   This section cited in 49 Pa. Code §  18.703 (relating to application for genetic counselor license); 49 Pa. Code §  18.704 (relating to application for genetic counselor license by uncertified persons); and 49 Pa. Code §  18.706 (relating to biennial registration of genetic counselor license).

Subchapter L. PROSTHETISTS, ORTHOTISTS, PEDORTHISTS AND ORTHOTIC FITTERS


GENERAL PROVISIONS

Sec.


18.801.    Purpose.
18.802.    Definitions.

QUALIFICATIONS FOR LICENSURE AS A PROSTHETIST


18.811.    Graduate permit.
18.812.    Clinical residency.
18.813.    Provisional prosthetist license.
18.814.    Prosthetist license.

QUALIFICATIONS FOR LICENSURE AS AN ORTHOTIST


18.821.    Graduate permit.
18.822.    Clinical residency.
18.823.    Provisional orthotist license.
18.824.    Orthotist license.

QUALIFICATIONS FOR LICENSURE AS A PEDORTHIST


18.831.    Temporary practice permit.
18.832.    Patient fitting experience.
18.833.    Pedorthist license.

QUALIFICATIONS FOR LICENSURE AS AN ORTHOTIC FITTER


18.841.    Temporary practice permit.
18.842.    Orthotic fitting care experience.
18.843.    Orthotic fitter license.

REGULATION OF PRACTICE


18.851.    Scope and standards of practice.
18.852.    Supervision and assistance.
18.853.    Unprofessional and immoral conduct.

BIENNIAL RENEWAL AND REACTIVATION


18.861.    Biennial renewal of license.
18.862.    Continuing education.
18.863.    Inactive and expired status of licenses; reactivation of inactive or expired license.
18.864.    Professional liability insurance coverage for licensed prosthetist, orthotist, pedorthist or orthotic fitter.

Authority

   The provisions of this Subchapter L issued under section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8); section 3 of the act of July 5, 2012 (P.L. 873, No. 90); and section 2 of the act of July 2, 2014 (P.L. 941, No. 104), unless otherwise noted.

Source

   The provisions of this Subchapter L adopted October 21, 2016, effective October 22, 2016, 46 Pa.B. 6618, unless otherwise noted.

GENERAL PROVISIONS


§ 18.801. Purpose.

 This subchapter implements section 13.5 of the act (63 P.S. §  422.13e), regarding prosthetists, orthotists, pedorthists and orthotic fitters.

§ 18.802. Definitions.

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

   ABC—American Board for Certification in Orthotics, Prosthetics & Pedorthics, Inc., a Board-approved organization with certification programs accredited by NCCA. The term includes a successor organization.

   Accommodative—Designed with a primary goal of conforming to an individual’s anatomy.

   BOC—Board of Certification/Accreditation International, Inc., a Board-approved organization with certification programs accredited by NCCA. The term includes a successor organization.

   CAAHEP—Commission on Accreditation of Allied Health Education Programs, recognized by the Council for Higher Education Accreditation to accredit prosthetic and orthotic education programs.

   Custom-designed or custom-fabricated device—A prosthesis, orthosis or pedorthic device that is designed or fabricated to comprehensive measurements or a patient model or mold for use by a patient in accordance with a prescription and which requires substantial clinical and technical judgment in its design, fabrication and fitting.

   Custom-fitted or custom-modified device—A prefabricated prosthesis, orthosis or pedorthic device to accommodate the patient’s measurement that is sized or modified for use by the patient in accordance with a prescription and which requires substantial clinical judgment and substantive alteration in its design for appropriate use.

   Hour of continuing education—At least 50 minutes of instruction, including relevant question and answer sessions, in an approved course of continuing education or an equivalent time that an online or correspondence course would be presented live.

   ICE—The Institute for Credentialing Excellence, previously known as the National Organization for Competency Assurance. The term includes a successor organization.

   Licensed prescribing practitioner—A physician, podiatrist, certified registered nurse practitioner or physician assistant, licensed by the practitioner’s respective licensing board, who may issue orders and prescriptions to a prosthetist, orthotist, pedorthist or orthotic fitter.

   NCCA—National Commission for Certifying Agencies or its successor.

   NCOPE—National Commission on Orthotic and Prosthetic Education, an organization that approves precertification education courses for pedorthists and accredits residency programs for prosthetists and orthotists.

   Orthosis—A custom-designed, custom-fabricated, custom-fitted or custom-modified device designed to externally provide support, alignment or prevention to the body or a limb for the purposes of correcting or alleviating a neuromuscular or musculoskeletal disease, injury or deformity.

   Orthotic fitter—An individual who is licensed by the Board to practice orthotic fitting.

   Orthotic fitter trainee—An individual who holds an orthotic fitter temporary practice permit issued by the Board and who is authorized to practice in accordance with §  18.842 (relating to orthotic fitting care experience).

   Orthotic fitting—The fitting, dispensing and adjusting of prefabricated orthotic devices pursuant to a written prescription of a licensed prescribing practitioner.

   Orthotic and prosthetic assistant—An unlicensed individual who, under the direct supervision of the orthotist or prosthetist, assists with patient care tasks assigned by the orthotist or prosthetist.

   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 a licensed orthotist or prosthetist.

   Orthotics—The practice of evaluating, measuring, designing, fabricating, assembling, fitting, adjusting or servicing an orthosis for the correction or alleviation of neuromuscular or musculoskeletal dysfunction, disease, injury or deformity pursuant to a written prescription of a licensed prescribing practitioner.

   Orthotist—An individual who is licensed by the Board to practice orthotics.

   Orthotist resident—An individual who holds a graduate permit issued by the Board and who is authorized to practice in accordance with § §  18.821 and 18.822 (relating to graduate permit; and clinical residency).

   Over-the-counter orthoses and pedorthic devices—Prefabricated, mass-produced items that are prepackaged and do not require professional advice or judgment in either size selection or use, including fabric or elastic supports, corsets, generic arch supports and elastic hose.

   Pedorthic device

     (i)   Therapeutic shoes, shoe modifications made for therapeutic purposes, partial foot prostheses, foot orthoses and below-the-knee pedorthic modalities.

     (ii)   The term does not include the following:

       (A)   Nontherapeutic, accommodative inlays and nontherapeutic accommodative footwear, regardless of method of manufacture.

       (B)   Unmodified, nontherapeutic over-the-counter shoes.

       (C)   Prefabricated, unmodified or unmodifiable foot care and footwear products.

   Pedorthic support personnel—An unlicensed individual who, under the direct onsite supervision of a pedorthist, assists a pedorthist in the provision of pedorthic care, or who provides technical support to a pedorthist, including fabricating, assembling, modifying and servicing pedorthic devices in accordance with the pedorthist’s specifications. Pedorthic support personnel may not practice prosthetics, orthotics, pedorthics or orthotic fitting.

   Pedorthics—The practice of evaluating, measuring, designing, fabricating, assembling, fitting, adjusting or servicing necessary to accomplish the application of a pedorthic device for the prevention or amelioration of painful or disabling conditions related to the lower extremities pursuant to a written prescription of a licensed prescribing practitioner.

   Pedorthist—An individual who is licensed by the Board to practice pedorthics.

   Pedorthist trainee—An individual who holds a temporary practice permit issued by the Board and who is authorized to practice in accordance with § §  18.831 and 18.832 (relating to temporary practice permit; and patient fitting experience).

   Podiatrist—An individual licensed under the Podiatry Practice Act (63 P.S. § §  42.1—42.21c) to practice podiatry.

   Prefabricated orthosis

     (i)   A brace or support designed to provide for alignment, correction or prevention of neuromuscular or musculoskeletal dysfunction, disease, injury or deformity.

     (ii)   The term does not include fabric or elastic supports, corsets, arch supports, low-temperature plastic splints, trusses, elastic hose, canes, crutches, soft cervical collars, dental appliances or other similar devices carried in stock and sold as over-the-counter items.

   Prosthesis

     (i)   A custom-designed, custom-fabricated, custom-fitted or custom-modified device to replace an absent external limb for purposes of restoring physiological function that is not surgically implanted.

     (ii)   The term does not include the following:

       (A)   Artificial eyes, ears, fingers or toes.

       (B)   Dental appliances.

       (C)   Cosmetic devices such as breast prostheses, eyelashes or wigs.

       (D)   Other devices that do not have a significant impact on the musculoskeletal functions of the body.

   Prosthetics—The practice of evaluating, measuring, designing, fabricating, assembling, fitting, adjusting or servicing a prosthesis pursuant to a written prescription of a licensed prescribing practitioner.

   Prosthetist—An individual who is licensed by the Board to practice prosthetics.

   Prosthetist resident—An individual who holds a graduate permit issued by the Board and who is authorized to practice in accordance with § §  18.811 and 18.812 (relating to graduate permit; and clinical residency).

   Provisionally-licensed orthotist—An individual who holds a provisional license issued by the Board and who is authorized to practice in accordance with §  18.823 (relating to provisional orthotist license).

   Provisionally-licensed prosthetist—An individual who holds a provisional license issued by the Board and who is authorized to practice in accordance with §  18.813 (relating to provisional prosthetist license).

Cross References

   This section cited in 49 Pa. Code §  18.842 (relating to orthotic fitting care experience).

QUALIFICATIONS FOR LICENSURE AS A PROSTHETIST


§ 18.811. Graduate permit.

 (a)  Prior to providing direct patient care during a clinical residency, an individual shall submit an application, on forms made available by the Board, for a graduate permit that authorizes the individual to practice as a prosthetist resident. The Board may grant a graduate permit to an individual who submits a completed application including the necessary supporting documents, pays the application fee in §  16.13(n) (relating to licensure, certification, examination and registration fees) and meets the qualifications in subsection (b).

 (b)  The Board may issue a graduate permit to practice as a prosthetist resident to an applicant who:

   (1)  Is of good moral character.

   (2)  Has earned a bachelor’s degree, post-baccalaureate certificate or higher degree from a CAAHEP-accredited education program with a major in prosthetics or prosthetics/orthotics. An applicant shall demonstrate this requirement by having the CAAHEP-accredited educational institution submit, directly to the Board, verification of completion of a bachelor’s degree, post-baccalaureate certificate or higher degree in prosthetics or prosthetics/orthotics, along with an official copy of the applicant’s transcript.

   (3)  Has registered with NCOPE as a prosthetist or prosthetist/orthotist resident. An applicant shall demonstrate this requirement by having NCOPE submit, directly to the Board, proof that the applicant has registered for an NCOPE-accredited prosthetic or prosthetic/orthotic residency program.

   (4)  Has complied with §  18.864 (relating to professional liability insurance coverage for licensed prosthetist, orthotist, pedorthist or orthotic fitter). An applicant shall demonstrate this requirement by submitting proof of professional liability insurance coverage through self-insurance, a personally purchased insurance policy or insurance provided by the applicant’s employer in accordance with §  18.864.

 (c)  The Board may deny an application for a graduate 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 graduate permit is valid during the clinical residency and for up to 90 days after successful completion of the clinical residency or until a provisional license is issued, whichever occurs first. A graduate permit is nonrenewable.

 (e)  An individual holding a graduate permit may use the title ‘‘prosthetist resident’’ and shall inform patients that the individual is completing a residency training program and is not fully licensed.

Cross References

   This section cited in 49 Pa. Code §  18.802 (relating to definitions); 49 Pa. Code §  18.813 (relating to provisional prosthetist license); and 49 Pa. Code §  18.814 (relating to prosthetist license).

§ 18.812. Clinical residency.

 (a)  A prosthetist resident shall practice only under the direct supervision of a licensed prosthetist within the clinical residency. 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 prosthetist resident and is responsible for countersigning within 15 days the entries in the patient’s clinical record.

 (b)  The clinical residency shall be accredited by NCOPE.

 (c)  The clinical residency shall be obtained subsequent to education and be at all levels of prosthetic care.

Cross References

   This section cited in 49 Pa. Code §  18.802 (relating to definitions); and 49 Pa. Code §  18.813 (relating to provisional prosthetist license).

§ 18.813. Provisional prosthetist license.

 (a)  An individual shall submit an application, on forms made available by the Board, for a provisional license which will authorize the individual to provide direct patient care, under direct supervision as defined in §  18.812(a) (relating to clinical residency), as a provisionally-licensed prosthetist following completion of a clinical residency. The Board may grant a provisional license to an individual who submits a completed application including the necessary supporting documents, pays the application fee in §  16.13(n) (relating to licensure, certification, examination and registration fees) and meets the qualifications in subsection (b).

 (b)  The Board may grant a provisional license to an individual who:

   (1)  Is of good moral character.

   (2)  Has earned a bachelor’s degree, post-baccalaureate certificate or higher degree from a CAAHEP-accredited education program with a major in prosthetics or prosthetics/orthotics. Unless previously submitted under §  18.811(b)(2) (relating to graduate permit), an applicant shall demonstrate this requirement by having the CAAHEP-accredited educational institution submit, directly to the Board, verification of completion of a bachelor’s degree, post-baccalaureate certificate or higher degree in prosthetics or prosthetics/orthotics, along with an official copy of the applicant’s transcript.

   (3)  Has completed an NCOPE-accredited clinical residency in prosthetics or prosthetics/orthotics. An applicant shall demonstrate this requirement by having the program director of the clinical residency program submit, directly to the Board, verification that the applicant completed an NCOPE-accredited clinical residency in prosthetics or prosthetics/orthotics.

   (4)  Has complied with §  18.864 (relating to professional liability insurance coverage for licensed prosthetist, orthotist, pedorthist or orthotic fitter). An applicant shall demonstrate this requirement by submitting proof of professional liability insurance coverage through self-insurance, a personally purchased insurance policy or insurance provided by the applicant’s employer in accordance with §  18.864.

 (c)  The Board may deny an application for a provisional license 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 provisional license is valid for a maximum of 2 years and is nonrenewable.

 (e)  An individual holding a provisional prosthetist license may use the title “provisionally-licensed prosthetist” and shall inform patients that the individual is not fully licensed.

Cross References

   This section cited in 49 Pa. Code §  18.802 (relating to definitions); and 49 Pa. Code §  18.814 (relating to prosthetist license).

§ 18.814. Prosthetist license.

 (a)  An applicant for a license to practice as a prosthetist 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(n) (relating to licensure, certification, examination and registration fees).

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

   (1)  Is of good moral character.

   (2)  Has earned a bachelor’s degree, post-baccalaureate certificate or higher degree from a CAAHEP-accredited education program with a major in prosthetics or prosthetics/orthotics. Unless previously submitted under §  18.811(b)(2) or §  18.813(b)(2) (relating to graduate permit; and provisional prosthetist license), an applicant shall demonstrate this requirement by having the CAAHEP-accredited educational institution submit, directly to the Board, verification of completion of a bachelor’s degree, post-baccalaureate certificate or higher degree in prosthetics or prosthetics/orthotics, along with an official copy of the applicant’s transcript.

   (3)  Has completed a minimum of 3,800 hours of experience in providing direct patient care services in prosthetics or in prosthetics and orthotics over a 2-year period. An applicant shall demonstrate this requirement by having the applicant’s employer or supervisor, the director of the applicant’s clinical residency program or a referral source file a verification on a form provided by the Board. If verification is made by a referral source, it must include a copy of the applicant’s Federal EIN and evidence of the date the applicant received the EIN.

   (4)  Holds current certification as a prosthethist, or as a prosthetist and orthotist, from ABC, BOC or another prosthetic credentialing organization whose certification program is recognized by ICE, accredited by NCCA and approved by the Board. An applicant shall demonstrate this requirement by having the organization send verification of certification directly to the Board.

   (5)  Has complied with §  18.864 (relating to professional liability insurance coverage for licensed prosthetist, orthotist, pedorthist or orthotic fitter). An applicant shall demonstrate this requirement by submitting proof of professional liability insurance coverage through self-insurance, a personally purchased insurance policy or insurance provided by the applicant’s employer in accordance with §  18.864.

   (6)  Has completed at least 3 hours of approved training in child abuse recognition and reporting in accordance with §  16.108(a) (relating to child abuse recognition and reporting—mandatory training requirement).

 (c)  The Board may deny an application for licensure as a prosthetist upon the grounds for disciplinary action in section 41 of the act (63 §  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)  An individual holding an active, unsuspended prosthetist license may use the title ‘‘prosthetist.’’

Authority

   The provisions of this §  18.814 amended under section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.814 amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial page (384340).

QUALIFICATIONS FOR LICENSURE AS AN ORTHOTIST


§ 18.821. Graduate permit.

 (a)  Prior to providing direct patient care during a clinical residency, an individual shall submit an application, on forms made available by the Board, for a graduate permit that authorizes the individual to practice as an orthotist resident. The Board may grant a graduate permit to an individual who submits a completed application including the necessary supporting documents, pays the application fee in §  16.13(o) (relating to licensure, certification, examination and registration fees) and meets the qualifications in subsection (b).

 (b)  The Board may issue a graduate permit to practice as an orthotist to an applicant who:

   (1)  Is of good moral character.

   (2)  Has earned a bachelor’s degree, post-baccalaureate certificate or higher degree from a CAAHEP-accredited education program with a major in orthotics or prosthetics/orthotics. An applicant shall demonstrate this requirement by having the CAAHEP-accredited educational institution submit, directly to the Board, verification of completion of a bachelor’s degree, post-baccalaureate certificate or higher degree in orthotics or prosthetics/orthotics, along with an official copy of the applicant’s transcript.

   (3)  Has registered with NCOPE as an orthotist or prosthetist/orthotist resident. An applicant shall demonstrate this requirement by having NCOPE submit, directly to the Board, proof that the applicant has registered for an NCOPE-accredited orthotic or prosthetic/orthotic residency program.

   (4)  Has complied with §  18.864 (relating to professional liability insurance coverage for licensed prosthetist, orthotist, pedorthist or orthotic fitter). An applicant shall demonstrate this requirement by submitting proof of professional liability insurance coverage through self-insurance, a personally purchased insurance policy or insurance provided by the applicant’s employer in accordance with §  18.864.

 (c)  The Board may deny an application for a graduate 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 graduate permit is valid during the clinical residency and for up to 90 days after successful completion of the clinical residency or until a provisional license is issued, whichever occurs first. A graduate permit is nonrenewable.

 (e)  An individual holding a graduate permit may use the title ‘‘orthotist resident’’ and shall inform patients that the individual is completing a residency training program and is not fully licensed.

Cross References

   This section cited in 49 Pa. Code §  18.802 (relating to definitions); 49 Pa. Code §  18.823 (relating to provisional orthotist license); and 49 Pa. Code §  18.824 (relating to orthotist license).

§ 18.822. Clinical residency.

 (a)  An orthotist resident shall practice only under the direct supervision of a licensed orthotist within the clinical residency. 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 orthotist resident and is responsible for countersigning within 15 days the entries in the patient’s clinical record.

 (b)  The clinical residency shall be accredited by NCOPE.

 (c)  The clinical residency shall be obtained subsequent to education and be at all levels of orthotic care.

Cross References

   This section cited in 49 Pa. Code §  18.802 (relating to definitions); and 49 Pa. Code §  18.823 (relating to provisional orthotist license).

§ 18.823. Provisional orthotist license.

 (a)  Following completion of the clinical residency, an individual may submit an application, on forms made available by the Board, for a provisional license which will authorize the individual to provide direct patient care under direct supervision as defined in §  18.822(a) (relating to clinical residency). The Board may grant a provisional license to an individual who submits a completed application including the necessary supporting documents, pays the application fee in §  16.13(o) (relating to licensure, certification, examination and registration fees) and meets the qualifications in subsection (b).

 (b)  The Board may grant a provisional license to an individual who:

   (1)  Is of good moral character.

   (2)  Has earned a bachelor’s degree, post-baccalaureate certificate or higher degree from a CAAHEP-accredited education program with a major in orthotics or prosthetics/orthotics. Unless previously submitted under §  18.821(b)(2) (relating to graduate permit), an applicant shall demonstrate this requirement by having the CAAHEP-accredited educational institution submit, directly to the Board, verification of completion of a bachelor’s degree, post-baccalaureate certificate or higher degree in orthotics or prosthetics/orthotics, along with an official copy of the applicant’s transcript.

   (3)  Has completed an NCOPE-accredited clinical residency in orthotics or prosthetics/orthotics. An applicant shall demonstrate this requirement by having the program director of the clinical residency program submit, directly to the Board, verification that the applicant completed an NCOPE-accredited clinical residency in orthotics or prosthetics/orthotics.

   (4)  Has complied with §  18.864 (relating to professional liability insurance coverage for licensed prosthetist, orthotist, pedorthist or orthotic fitter). An applicant shall demonstrate this requirement by submitting proof of professional liability insurance coverage through self-insurance, a personally purchased insurance policy or insurance provided by the applicant’s employer in accordance with §  18.864.

 (c)  The Board may deny an application for a provisional license 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 provisional license is valid for a maximum of 2 years and is nonrenewable.

 (e)  An individual holding a provisional orthotist license may use the title “provisionally-licensed orthotist” and shall inform patients that the individual is not fully licensed.

Cross References

   This section cited in 49 Pa. Code §  18.802 (relating to definitions); and 49 Pa. Code §  18.824 (relating to orthotist license).

§ 18.824. Orthotist license.

 (a)  An applicant for a license to practice as an orthotist 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(o) (relating to licensure, certification, examination and registration fees).

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

   (1)  Is of good moral character.

   (2)  Has earned a bachelor’s degree, post-baccalaureate certificate or higher degree from a CAAHEP-accredited education program with a major in orthotics or prosthetics/orthotics. Unless previously submitted under §  18.821(b)(2) or §  18.823(b)(2) (relating to graduate permit; and provisional orthotist license), an applicant shall demonstrate this requirement by having the CAAHEP-accredited educational institution submit, directly to the Board, verification of completion of a bachelor’s degree, post-baccalaureate certificate or higher degree in orthotics or prosthetics/orthotics, along with an official copy of the applicant’s transcript.

   (3)  Has completed a minimum of 3,800 hours of experience in providing direct patient care services in orthotics or in prosthetics and orthotics over a 2-year period. An applicant shall demonstrate this requirement by having the applicant’s employer or supervisor, the director of the applicant’s clinical residency program or a referral source file a verification on a form provided by the Board. If verification is made by a referral source, it must include a copy of the applicant’s Federal EIN and evidence of the date the applicant received the EIN.

   (4)  Holds current certification as an orthotist, or as a prosthetist and orthotist, from ABC, BOC or another orthotic credentialing organization whose certification program is recognized by ICE, accredited by NCCA and approved by the Board. An applicant shall demonstrate this requirement by having the organization send verification of certification directly to the Board.

   (5)  Has complied with §  18.864 (relating to professional liability insurance coverage for licensed prosthetist, orthotist, pedorthotist or orthotic fitter). An applicant shall demonstrate this requirement by submitting proof of professional liability insurance coverage through self-insurance, a personally purchased insurance policy or insurance provided by the applicant’s employer in accordance with §  18.864.

   (6)  Has completed at least 3 hours of approved training in child abuse recognition and reporting in accordance with §  16.108(a) (relating to child abuse recognition and reporting—mandatory training requirement).

 (c)  The Board may deny an application for licensure as an orthotist 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)  An individual holding an active, unsuspended orthotist license may use the title ‘‘orthotist.’’

Authority

   The provisions of this §  18.824 amended under section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.824 amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial pages (384343) to (384344).

QUALIFICATIONS FOR LICENSURE AS A PEDORTHIST


§ 18.831. Temporary practice permit.

 (a)  After completion of an NCOPE-approved pedorthic education program and prior to providing pedorthic patient care in this Commonwealth, an individual shall submit an application for a temporary practice permit authorizing the individual to practice as a pedorthist trainee on forms made available by the Board. The Board may grant a temporary practice permit to an applicant who submits a completed application including the necessary supporting documents, pays the application fee in §  16.13(p) (relating to licensure, certification, examination and registration fees) and meets the qualifications in subsection (b).

 (b)  The Board may issue a temporary practice permit to an applicant who:

   (1)  Is of good moral character.

   (2)  Has successfully completed an NCOPE-approved pedorthic precertification education program. An applicant shall demonstrate completion of an NCOPE-approved pedorthic precertification education program 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 1 year and is nonrenewable.

 (e)  An individual holding a temporary practice permit may use the title ‘‘pedorthist trainee’’ and shall inform patients that the individual is completing a training program and is not fully licensed.

Cross References

   This section cited in 49 Pa. Code §  18.802 (relating to definitions); and 49 Pa. Code §  18.833 (relating to pedorthist license).

§ 18.832. Patient fitting experience.

 (a)  A pedorthist trainee with a temporary practice permit shall practice only under the direct supervision of a licensed prosthetist, orthotist or pedorthist within the work experience. 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 pedorthist trainee and is responsible for countersigning within 15 days the entries in the patient’s clinical record.

 (b)  The supervised patient fitting experience shall be obtained subsequent to education and encompass all aspects of pedorthic care.

Cross References

   This section cited in 49 Pa. Code §  18.802 (relating to definitions).

§ 18.833. Pedorthist license.

 (a)  An applicant for a license to practice as a pedorthist 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(p) (relating to licensure, certification, examination and registration fees).

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

   (1)  Is of good moral character.

   (2)  Has successfully completed an NCOPE-approved pedorthic precertification education program. Unless previously submitted under §  18.831 (relating to temporary practice permit), an applicant shall demonstrate completion of an NCOPE-approved pedorthic precertification education program by having the educational institution submit, directly to the Board, verification of completion.

   (3)  Has completed a minimum of 1,000 hours of supervised patient fitting experience providing direct patient care in pedorthics. An applicant shall demonstrate this requirement by having the applicant’s employer, supervisor or a referral source file a verification on a form provided by the Board. If verification is made by a referral source, it must include a copy of the applicant’s Federal EIN and evidence of the date the applicant received the EIN.

   (4)  Holds current certification as a pedorthist from ABC, BOC or another pedorthic credentialing organization whose program is recognized by ICE, accredited by NCCA and approved by the Board. An applicant shall demonstrate this requirement by having the organization send verification of certification directly to the Board.

   (5)  Has complied with §  18.864 (relating to professional liability insurance coverage for licensed prosthetist, orthotist, pedorthist or orthotic fitter). An applicant shall demonstrate this requirement by submitting proof of professional liability insurance coverage through self-insurance, a personally purchased insurance policy or insurance provided by the applicant’s employer in accordance with §  18.864.

   (6)  Has completed at least 3 hours of approved training in child abuse recognition and reporting in accordance with §  16.108(a) (relating to child abuse recognition and reporting—mandatory training requirement).

 (c)  The Board may deny an application for licensure as a pedorthist 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)  An individual holding an active, unsuspended pedorthist license may use the title ‘‘pedorthist.’’

Authority

   The provisions of this §  18.833 amended under section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.833 amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial page (384345).

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.

Authority

   The provisions of this §  18.841 amended under sections 8 and 13.5(a) of the Medical Practice Act of 1985 (63 P.S. § §  422.8 and 422.13e(a)).

Source

   The provisions of this §  18.841 amended January 6 2023, effective January 7, 2023, 53 Pa.B. 16. Immediately preceding text appears at serial pages (409245) to (409246).

Cross References

   This section cited in 49 Pa. Code §  18.843 (relating to orthotic fitter license).

§ 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).

Authority

   The provisions of this §  18.842 amended under sections 8 and 13.5(a) of the Medical Practice Act of 1985 (63 P.S. § §  422.8 and 422.13e(a)).

Source

   The provisions of this §  18.842 amended January 6, 2023, effective January 7, 2023, 53 Pa.B. 16. Immediately preceding text appears at serial page (409246).

Cross References

   This section cited in 49 Pa. Code §  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.

   (3)  Has completed a minimum of 1,000 hours of documented orthotic fitting care experience. An applicant shall demonstrate this requirement by having the applicant’s employer, supervisor or a referral source file a verification on a form provided by the Board. If verification is made by a referral source, it must include a copy of the applicant’s Federal EIN and evidence of the date the applicant received the EIN.

   (4)  Holds current certification as an orthotic fitter from ABC, BOC or another orthotic fitter credentialing organization whose program is recognized by ICE, accredited by NCCA and approved by the Board. An applicant shall demonstrate this requirement by having the organization send verification of certification directly to the Board.

   (5)  Has complied with §  18.864 (relating to professional liability insurance coverage for licensed prosthetist, orthotist, pedorthist or orthotic fitter). An applicant shall demonstrate this requirement by submitting proof of professional liability insurance coverage through self-insurance, a personally purchased insurance policy or insurance provided by the applicant’s employer in accordance with §  18.864.

   (6)  Has completed at least 3 hours of approved training in child abuse recognition and reporting in accordance with §  16.108(a) (relating to child abuse recognition and reporting—mandatory training requirement).

 (c)  The Board may deny an application for licensure as an orthotic fitter 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)  An individual holding an active, unsuspended orthotic fitter license may use the title ‘‘orthotic fitter.’’

Authority

   The provisions of this §  18.843 amended under sections 8 and 13.5(a) of the Medical Practice Act of 1985 (63 P.S. § §  422.8 and 422.13e(a)); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.843 amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899; amended January 6, 2023, effective January 7, 2023, 53 Pa.B. 16. Immediately preceding text appears at serial pages (409246) to (409247).

REGULATION OF PRACTICE


§ 18.851. Scope and standards of practice.

 (a)  Prior to providing services to a patient, a prosthetist, orthotist, pedorthist or orthotic fitter shall review the prescription and referral or valid order of the licensed prescribing practitioner and understand conditions or restrictions placed on the course of treatment by the licensed prescribing practitioner.

 (b)  Prior to providing services to a patient, a prosthetist, orthotist, pedorthist or orthotic fitter shall ensure the patient has undergone a medical diagnostic examination or has had the results of a recently performed medical diagnostic examination reviewed by a licensed prescribing practitioner by obtaining a copy of the prescription and relevant clinical notes.

 (c)  A prosthetist, orthotist, pedorthist or orthotic fitter shall retain a copy of the prescription and referral or valid order, clinical notes and results of the relevant medical diagnostic examination in the patient’s file.

 (d)  A prosthetist, orthotist, pedorthist or orthotic fitter may not accept a prescription and referral or order when the prosthetist, orthotist, pedorthist or orthotic fitter knows, or has good cause to believe, that the device cannot be furnished 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 these instances, the prosthetist, orthotist, pedorthist or orthotic fitter shall consult with the licensed prescribing practitioner who wrote the prescription and referral or order and disclose the issue to the patient.

 (e)  For purposes of this section, the results of the medical diagnostic examination must include, at a minimum, diagnosis, prognosis, medical necessity and duration of need relevant to the practice of the prosthetist, orthotist, pedorthist or orthotic fitter.

§ 18.852. Supervision and assistance.

 (a)  A prosthetist or orthotist may assign tasks related to the practice of prosthetics or orthotics to an orthotic and prosthetic assistant working under the prosthetist’s or orthotist’s direct supervision provided that assignment of the tasks is consistent with the standards of acceptable prosthetic and orthotic practice embraced by the prosthetic and orthotic community in this Commonwealth.

 (b)  A prosthetist or orthotist may assign tasks related to the fabrication, assembly, modification and servicing of prosthetic and orthotic devices to an orthotic and prosthetic technician working to the specifications provided by the prosthetist or orthotist.

 (c)  A pedorthist may assign to pedorthic support personnel tasks related to pedorthic care when direct supervision is provided, and may assign technical tasks to be completed to the specifications provided by the pedorthist if assignment of the tasks is consistent with the standards of acceptable pedorthic practice embraced by the pedorthic community in this Commonwealth.

 (d)  For purposes of this section, ‘‘direct supervision’’ means that the prosthetist, orthotist or pedorthist is on the premises, periodically observes and is continuously available to provide guidance to the assistant or pedorthic support personnel. For purposes of this section “to the specifications provided” means that the prosthetist, orthotist or pedorthist has provided all necessary measurements and instructions to the technician for the fabrication, assembly, modification and servicing of the device.

 (e)  Only a prosthetist, orthotist or pedorthist may perform an initial patient evaluation and the final provision of a prosthetic, orthotic or pedorthic device to determine the appropriateness of the device delivered to a patient.

 (f)  The prosthetist, orthotist or pedorthist assigning and supervising tasks shall bear ultimate responsibility for the completed tasks.

Cross References

   This section cited in 49 Pa. Code §  18.853 (relating to unprofessional and immoral conduct).

§ 18.853. Unprofessional and immoral conduct.

 (a)  A licensee under this subchapter is subject to refusal of license or permit or disciplinary action under sections 22 and 41 of the act (63 P.S. § §  422.22 and 422.41). Following a final determination subject to the right of notice, hearing and adjudication, and the right of appeal therefrom in accordance with 2 Pa.C.S. § §  501—508 and 701—704 (relating to Administrative Agency Law), this chapter and 1 Pa. Code Part II (relating to General Rules of Administrative Practice and Procedure), the Board may refuse licensure or impose any of the corrective actions in section 42 of the act (63 P.S. §  422.42).

 (b)  Unprofessional conduct includes:

   (1)  Engaging in conduct prohibited under §  16.61(a) or §  16.110 (relating to unprofessional and immoral conduct; and sexual misconduct).

   (2)  Performing an act in a health care profession in a fraudulent, incompetent or negligent manner.

   (3)  Violating a provision of the act or this chapter setting a standard of professional conduct.

   (4)  Engaging in health care practice beyond the licensee’s authority to practice.

   (5)  Representing oneself to be a physician or other health care practitioner whose profession the licensee is not licensed to practice.

   (6)  Practicing while the licensee’s ability to do so is impaired by alcohol, drugs, physical disability or mental instability.

   (7)  Revealing personally identifiable facts obtained as the result of a practitioner-patient relationship without the prior consent of the patient, except as authorized or required under statute or regulation.

   (8)  Misconduct in the practice of the licensee’s profession or performing tasks fraudulently, incompetently or negligently, or by use of methods of treatment which are not in accordance with treatment processes accepted by a reasonable segment of the profession.

   (9)  The promotion of the sale of services and devices in a manner as to exploit the patient or client for the financial gain of the practitioner or a third party.

   (10)  Directly or indirectly offering, giving, soliciting or receiving, or agreeing to receive a fee or other consideration to or from a third party for the referral of a patient or client.

   (11)  Supervising or assigning tasks to assistants, technicians or support personnel contrary to §  18.852 (relating to supervision and assistance).

   (12)  Over-utilizing services by providing excessive evaluation or treatment procedures not warranted by the condition of the patient or by continuing treatment beyond the point of possible benefit.

   (13)  Making gross misrepresentations, deliberate misrepresentations or misleading claims as to:

     (i)   The licensee’s professional qualifications.

     (ii)   The efficacy or value of:

       (A)   The treatments or remedies given to a patient by the licensee.

       (B)   The treatments or remedies recommended to a patient by the licensee.

       (C)   The treatments given to a patient by another practitioner.

       (D)   The recommendations made to a patient by another practitioner.

   (14)  Overcharging for professional services, including filing false statements for collection of fees for which services are not rendered.

   (15)  Failing to maintain a record for each patient that accurately reflects the evaluation and treatment of the patient.

   (16)  Advertising or soliciting for patronage in a manner that is fraudulent or misleading. Examples of advertising or soliciting which is considered fraudulent or misleading include:

     (i)   Advertising by means of testimonials, anecdotal reports of orthotics, prosthetics or pedorthics practice successes, or claims of superior quality of care to entice the public.

     (ii)   Advertising which contains false, fraudulent, deceptive or misleading materials, warranties or guarantees of success, statements which play upon vanities or fears of the public, or statements which promote or produce unfair competition.

 (c)  In addition to the conduct listed in §  16.61(b) or §  16.110, immoral conduct includes:

   (1)  Misrepresenting or concealing a material fact in obtaining a license issued by the Board or renewal, reactivation or reinstatement thereof.

   (2)  Being convicted of a crime involving moral turpitude, dishonesty or corruption in the courts of the Commonwealth, the United States, another state, the District of Columbia, a territory of the United States or another country.

   (3)  Committing an act involving moral turpitude, dishonesty or corruption.

Cross References

   This section cited in 49 Pa. Code §  18.811 (relating to graduate permit); 49 Pa. Code §  18.813 (relating to provisional prosthetist license); 49 Pa. Code §  18.814 (relating to prosthetist license); 49 Pa. Code §  18.821 (relating to graduate permit); 49 Pa. Code §  18.823 (relating to provisional orthotist license); 49 Pa. Code §  18.824 (relating to orthotist license); 49 Pa. Code §  18.831 (relating to temporary practice permit); 49 Pa. Code §  18.833 (relating to pedorthist license); 49 Pa. Code §  18.841 (relating to temporary practice permit); and 49 Pa. Code §  18.843 (relating to orthotic fitter license).

BIENNIAL RENEWAL AND REACTIVATION


§ 18.861. Biennial renewal of license.

 (a)  The license of a prosthetist, orthotist, pedorthist or orthotic fitter will expire biennially on December 31 of each even-numbered year in accordance with §  16.15 (relating to biennial registration; inactive status and unregistered status). A prosthetist, orthotist, pedorthist or orthotic fitter may not practice after December 31 of an even-numbered year unless the prosthetist, orthotist, pedorthist or orthotic fitter has completed the biennial renewal process and the Board has issued a current license.

 (b)  As a condition of biennial registration, a prosthetist, orthotist, pedorthist or orthotic fitter shall:

   (1)  Submit a completed application, including payment of the biennial renewal fee in §  16.13 (relating to licensure, certification, examination and registration fees) for application for biennial renewal of prosthetist, orthotist, pedorthist or orthotic fitter license.

   (2)  Disclose on the application a license to practice as a prosthetist, orthotist, pedorthist or orthotic fitter in another state, territory, possession or country.

   (3)  Disclose on the application disciplinary action pending before or taken by an appropriate health care licensing authority in another jurisdiction or the licensee’s credentialing body since the most recent application for biennial renewal, whether or not licensed to practice in that other jurisdiction.

   (4)  Disclose on the application any pending criminal charges and any finding or verdict of guilt, admission of guilt, plea of nolo contendere, probation without verdict, disposition in lieu of trial or accelerated rehabilitative disposition in any criminal matter since the most recent application for biennial renewal.

   (5)  Verify on the application that the licensed prosthetist, orthotist, pedorthist or orthotic fitter has completed the continuing education mandated by section 13.5(g)(1) or (2) of the act (63 P.S. §  422.13e(g)(1) and (2)) during the biennial period immediately preceding the period for which renewal is sought in accordance with §  18.862 (relating to continuing education).

   (6)  Verify on the application that the licensee maintains professional liability insurance coverage in accordance with section 13.5(i) of the act and §  18.864 (relating to professional liability insurance coverage for licensed prosthetist, orthotist, pedorthist or orthotic fitter).

§ 18.862. Continuing education.

 (a)  Credit hour requirements. A licensed prosthetist, orthotist, pedorthist or orthotic fitter shall satisfy the following continuing education credit hour requirements:

   (1)  As a condition for biennial renewal, a prosthetist shall complete at least 24 hours of ABC-approved or BOC-approved continuing education applicable to the practice of prosthetics and an orthotist shall complete at least 24 hours of ABC-approved or BOC-approved continuing education applicable to the practice of orthotics. At least 2 of the required 24 hours shall be completed in approved training in child abuse recognition and reporting in accordance with §  16.108(b) (relating to child abuse recognition and reporting—mandatory training requirement).

   (2)  As a condition for biennial renewal, a pedorthist shall complete at least 13 hours of ABC-approved or BOC-approved continuing education applicable to the practice of pedorthics and an orthotic fitter shall complete at least 13 hours of ABC-approved or BOC-approved continuing education applicable to the practice of orthotic fitting. At least 2 of the required 13 hours shall be completed in approved training in child abuse recognition and reporting in accordance with §  16.108(b).

   (3)  Credit for continuing education will not be given for courses in office management or practice building.

   (4)  A licensee is not required to complete continuing education during the biennium in which the licensee was first licensed.

   (5)  Except when reactivating an inactive license, when the Board has granted a waiver, or when ordered by the Board, continuing education credits may be used to satisfy the continuing education credit hour requirements only for the biennial period in which the credits were earned. An hour of continuing education may not be used to satisfy the requirements of paragraph (1) or (2) for more than one biennium.

   (6)  A licensee may request a waiver of the continuing education credit hour requirements because of serious illness, emergency, military service or other demonstrated hardship by submitting a request for waiver with supporting documentation to the Board at least 90 days prior to the end of the biennial renewal period for which the waiver is sought. The Board may grant the waiver request in whole or in part and may extend the deadline by which the credit hour requirements must be met.

 (b)  Disciplinary action. A licensee may be subject to disciplinary action if the licensee submits false information to the Board regarding completion of the continuing education credit hour requirements to complete biennial renewal or fails to complete the continuing education hour requirements and practices as a prosthetist, orthotist, pedorthist or orthotic fitter after the end of the biennial period.

 (c)  Documentation of continuing education. A licensee shall maintain documentation of completion of continuing education by maintaining the certificate of attendance or completion issued by the course provider. A licensee shall maintain the certificates for at least 5 years after the end of the biennial renewal period in which the continuing education was completed. A certificate must include the name of the course provider, the name and date of the course, the name of the licensee, the number of credit hours based on a 50-minute hour and the category of continuing education, if applicable.

Authority

   The provisions of this §  18.862 amended under section 8 of the Medical Practice Act of 1985 (63 P.S. §  422.8); and 23 Pa.C.S. §  6383(b)(2).

Source

   The provisions of this §  18.862 amended March 25, 2022, effective March 26, 2022, 52 Pa.B. 1899. Immediately preceding text appears at serial pages (384351) to (384352).

Cross References

   This section cited in 49 Pa. Code §  18.861 (relating to biennial renewal of license); and 49 Pa. Code §  18.863 (relating to inactive and expired status of licenses; reactivation of inactive or expired license).

§ 18.863. Inactive and expired status of licenses; reactivation of inactive or expired license.

 (a)  A prosthetist, orthotist, pedorthist or orthotic fitter license will become inactive if the licensee requests in writing that the Board place the license on inactive status. The Board will provide written confirmation of inactive status to the licensee at the licensee’s last known address on file with the Board.

 (b)  A prosthetist, orthotist, pedorthist or orthotic fitter license will be classified as expired if the licensee fails to renew the license by the expiration of the biennial renewal period on December 31 of each even-numbered year. The Board will provide written notice to a licensee who fails to make biennial renewal by sending a notice to the licensee’s last known address on file with the Board.

 (c)  A prosthetist, orthotist, pedorthist or orthotic fitter whose license has become inactive or expired may not practice in this Commonwealth until the license has been reactivated.

 (d)  To reactivate an inactive or expired license, the licensee shall apply on forms made available by the Board and fully answer the questions. The licensee shall:

   (1)  Include the documentation required under §  18.862(c) (relating to continuing education) for the immediately preceding biennium. Unless waived by the Board under section 13.5(g)(7) of the act (63 P.S. §  422.13e(g)(7)), the Board will not reactivate a license until the required continuing education for the preceding biennium has been successfully completed.

   (2)  Pay the current biennial renewal fee and the reactivation fee in §  16.13 (relating to licensure, certification, examination and registration fees).

   (3)  Verify that the licensee did not practice as a prosthetist, orthotist, pedorthist or orthotic fitter in this Commonwealth while the license was inactive or expired except as provided in subsection (e).

 (e)  A licensee who has practiced with an inactive or expired license and who cannot make the verification required under subsection (d)(3) shall also pay the fees required under section 225 of the Bureau of Professional and Occupational Affairs Fee Act (63 P.S. §  1401-225), as described in this subsection. Payment of a late fee does not preclude the Board from taking disciplinary action for practicing as a prosthetist, orthotist, pedorthist or orthotic fitter without a currently renewed license.

   (1)  A licensee whose license was active at the end of the immediately preceding biennial renewal period and who practiced after the license became inactive or expired shall pay a late fee of $5 for each month or part of a month from the beginning of the current biennium until the date the reactivation application is filed.

   (2)  A licensee whose license has been inactive or expired since before the beginning of the current biennium shall pay the biennial renewal fee for each biennial renewal period during which the licensee practiced and shall pay a late fee of $5 for each month or part of a month from the first date the licensee practiced as a prosthetist, orthotist, pedorthist or orthotic fitter in this Commonwealth after the license became inactive or expired until the date the reactivation application is filed.

 (f)  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.

§ 18.864. Professional liability insurance coverage for licensed prosthetist, orthotist, pedorthist or orthotic fitter.

 (a)  A licensed prosthetist, orthotist, pedorthist or orthotic fitter shall maintain a level of professional liability insurance coverage in the minimum amount of $1 million per occurrence or claims made as required under section 13.5(i) of the act (63 P.S. §  422.13e(i)) and provide proof of coverage upon request.

 (b)  Proof of professional liability insurance coverage includes:

   (1)  A certificate of insurance or copy of the declaration page from the 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 licensee who does not have professional liability insurance coverage as required under section 13.5(i) of the act may not practice as a prosthetist, orthotist, pedorthist or orthotic fitter in this Commonwealth.

Cross References

   This section cited in 49 Pa. Code §  18.811 (relating to graduate permit); 49 Pa. Code §  18.813 (relating to provisional prosthetist license); 49 Pa. Code §  18.814 (relating to prosthetist license); 49 Pa. Code §  18.821 (relating to graduate permit); 49 Pa. Code §  18.823 (relating to provisional orthotist license); 49 Pa. Code §  18.824 (relating to orthotist license); 49 Pa. Code §  18.833 (relating to pedorthist license); 49 Pa. Code §  18.843 (relating to orthotic fitter license); and 49 Pa. Code §  18.861 (relating to biennial renewal of license).

Subchapter M. REGISTRATION OF NATUROPATHIC DOCTORS


Sec.


18.901.    Purpose.
18.902.    Definitions.
18.903.    Application for naturopathic doctor registration.
18.904.    Biennial registration of naturopathic doctor.
18.905.    Inactive status; reactivation of inactive or expired registration.
18.906.    Display of registration.
18.907.    Acceptable titles and professional designations by registrants; prohibited titles.
18.908.    Informed consent and disclosure of financial interests.
18.909.    Naturopathic records.
18.910.    Advertising.
18.911.    Code of Ethics.
18.912.    Sexual misconduct.
18.913.    Grounds for discipline.

Authority

   The provisions of this Subchapter M added under sections 202(6), 203(b) and (c) and 207 of the Naturopathic Doctor Registration Act (63 P.S. § §  272.202(6), 272.203(b) and (c) and 272.207), unless otherwise noted.

Source

   The provisions of this Subchapter M added May 17, 2024, effective May 18, 2024, 54 Pa.B. 2780, unless otherwise noted.

§ 18.901. Purpose.

 This subchapter implements the NDRA pertaining to the registration of naturopathic doctors.

§ 18.902. Definitions.

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

   Authorization to practice—A license, registration, certificate, permit, authorization or approval issued by a state or Federal agency which authorizes the holder to advertise, engage in, or both advertise and engage in the practice of a profession or occupation.

   CNME—Council on Naturopathic Medical Education—The accrediting body which grants candidacy and accreditation to programs of naturopathic medicine for the education of naturopathic doctors.

   Marketing activity—A communication about a service or merchandise that encourages recipients of the communication to purchase or use the merchandise or service. For purposes of this chapter, the term does not include a service from or referral to another health care practitioner.

   Merchandise—Items that can be sold including vitamins, supplements, food, food extracts, homeopathic remedies, botanical medicines and herbs.

   NABNE—North American Board of Naturopathic Examiners—The organization which administers the NPLEX.

   NDRA—The Naturopathic Doctor Registration Act (63 P.S. § §  272.101—272.301).

   NPLEX—Naturopathic Physicians Licensing Examinations—The licensing examination accepted by the Board as a prerequisite to registration, consisting of Part I—Biomedical Science Examination and Part II—Core Clinical Science Examination, or its successor recognized by the Board.

   Natural therapies—Treatment of an individual through the use of substances in which the active ingredient is derived from plant, mineral or fungal sources, or any substance found in nature, and which may also contain common pharmaceutical excipients, and nonprescription drugs as defined by the Federal Food, Drug, and Cosmetic Act (52 Stat. 1040, 21 U.S.C. § §  301—399g).

   Naturopathic doctor—An individual who holds an active registration issued by the Board under the NDRA.

   Naturopathic medicine—Naturopathic physical medicine, natural therapies, naturopathic counseling or a combination thereof, to support and stimulate the individual’s self-healing processes.

   Naturopathic physical medicine—The use of the physical agents of air, water, heat, cold, sound and light, and the physical modalities of electrotherapy, biofeedback, diathermy, ultraviolet light, ultrasound, hydrotherapy and exercise, including naturopathic manipulation and mobilization therapy.

   Naturopathic service—Providing or performing naturopathic physical medicine, natural therapies, naturopathic counseling or a combination thereof, to support and stimulate an individual’s self-healing processes.

   Regionally accredited or pre-accredited college or university—A college or university which is accredited or pre-accredited by one of the following:

     (1)   Accrediting Commission of Career Schools and Colleges.

     (2)   Accrediting Council for Continuing Education and Training.

     (3)   Accrediting Council for Independent Colleges and Schools.

     (4)   Council on Occupational Education.

     (5)   Distance Education Accrediting Commission.

     (6)   Higher Learning Commission.

     (7)   Middle States Commission on Higher Education.

     (8)   Middle States Commission on Secondary Schools.

     (9)   New England Commission of Higher Education.

     (10)   New York State Board of Regents and the Commissioner of Education.

     (11)   Northwest Commission on Colleges and Universities.

     (12)   Southern Association of Colleges and Schools, Commission on Colleges.

     (13)   Western Association of Schools and Colleges, Accrediting Commission for Community and Junior Colleges.

     (14)   Western Association of Schools and Colleges, Senior Colleges and University Commission.

     (15)   Other regional or National accrediting agency which has been recognized by the United States Department of Education as being a reliable authority concerning the quality of education or training offered by the institutions of higher education or higher education programs they accredit.

§ 18.903. Application for naturopathic doctor registration.

 (a)  An applicant for a registration to practice naturopathic medicine shall submit, on an application made available by the Board, a completed application for a registration, including the necessary supporting documents, including information required by §  16.16 (relating to reporting of disciplinary actions, criminal dispositions and other licenses, certificates or authorizations to practice) and pay the application fee in §  16.13 (relating to licensure, certification, examination and registration fees).

 (b)  Except as otherwise provided by law, the Board will issue a registration as a naturopathic doctor to an applicant who meets all of the following requirements:

   (1)  Holds a bachelor’s degree from a regionally accredited or pre-accredited college or university or the equivalent.

   (2)  Holds a doctoral degree from an institutionally accredited or pre-accredited college or university offering a naturopathic doctor program which has been granted programmatic candidacy or accreditation by the CNME which consists of at least 4,100 total credit hours in basic and clinical sciences and naturopathic philosophy and modalities, including at least 2,500 hours of academic instruction and at least 1,200 hours of supervised clinical training. Proof of the degree shall be sent directly from the applicant’s education program and include an official transcript.

   (3)  Has passed Parts I and II of a competency-based National naturopathic licensing examination administered by the NABNE or a successor agency. An applicant who graduated prior to 1986 shall demonstrate a passing score on a state naturopathic examination.

   (4)  Holds a current basic cardio-pulmonary resuscitation (CPR) certificate issued by the American Heart Association, American Red Cross or a similar health authority or professional body approved by the Board.

   (5)  Has completed at least 3 hours of approved education/training in child abuse recognition and reporting requirements as set forth in 23 Pa.C.S. §  6383(b)(3)(i) (relating to education and training) and in §  16.108(a) (relating to child abuse recognition and reporting—mandatory training requirement).

   (6)  Is of good moral character.

 (c)  The Board may deny an application for registration as a naturopathic doctor upon any of the grounds for disciplinary action in §  18.913 (relating to grounds for discipline).

§ 18.904. Biennial registration of naturopathic doctor.

 (a)  The registration of a naturopathic doctor will expire biennially on December 31 of each even-numbered year in accordance with §  16.15 (relating to biennial registration; inactive status and unregistered status). A naturopathic doctor may not use the title of ‘‘naturopathic doctor,’’ ‘‘doctor of naturopathic medicine,’’ ‘‘registered naturopathic doctor’’ or any other term implying that the individual is currently registered as a naturopathic doctor unless the individual holds a current and unexpired registration.

 (b)  As a condition of biennial renewal, a naturopathic doctor shall:

   (1)  Submit a completed application, including payment of the biennial registration fee in §  16.13 (relating to licensure, certification, examination and registration fees).

   (2)  Disclose on the application any authorization to practice as a naturopathic doctor in another state, district, territory, possession or country.

   (3)  Disclose on the application disciplinary action pending before, or taken by, the appropriate licensing, registration or certification authority in another jurisdiction since the most recent application for biennial registration, whether or not authorized to practice or advertise in that other jurisdiction.

   (4)  Affirm that the applicant holds a current basic cardio-pulmonary resuscitation (CPR) certificate issued by the American Heart Association, American Red Cross or a similar health authority or professional body approved by the Board.

   (5)  Certify that the applicant has completed at least 2 hours of approved continuing education in child abuse recognition and reporting as set forth in 23 Pa.C.S. §  6383(b)(3)(ii) (relating to education and training) and in §  16.108(b) (relating to child abuse recognition and reporting—mandatory training requirement).

§ 18.905. Inactive status; reactivation of inactive or expired registration.

 (a)  A naturopathic doctor may request in writing that the Board place the registration on inactive status. Confirmation of inactive status will be forwarded to the registrant. A naturopathic doctor may not use the title of ‘‘naturopathic doctor,’’ ‘‘doctor of naturopathic medicine,’’ ‘‘registered naturopathic doctor’’ or any other term implying that the individual is currently registered as a naturopathic doctor while on inactive status.

 (b)  To reactivate an inactive or expired registration, the registrant shall apply for reactivation by completing an application for reactivation on a form made available by the Board. The registrant shall:

   (1)  Pay the current biennial registration fee specified in §  16.13 (relating to licensure, certification, examination and registration fees) and any applicable late fees required under section 225 of the Bureau of Professional and Occupational Affairs Fee Act (63 P.S. §  1401-225).

   (2)  Disclose whether the registrant used the title of ‘‘naturopathic doctor,’’ ‘‘doctor of naturopathic medicine,’’ ‘‘registered naturopathic doctor’’ or any other term implying that the individual was currently registered as a naturopathic doctor in the Commonwealth while the registration was inactive or expired.

   (3)  Disclose on the application any authorization to practice as a naturopathic doctor in another state, district, territory, possession or country.

   (4)  Disclose on the application disciplinary action pending before or taken by the appropriate licensing, registration, or certification authority in another jurisdiction since the most recent application for biennial registration, whether or not authorized to practice or advertise in that other jurisdiction.

   (5)  Submit evidence the registrant holds a current basic cardio-pulmonary resuscitation (CPR) certificate issued by the American Heart Association, American Red Cross or a similar health authority or professional body approved by the Board.

   (6)  Verify completion of at least 2 hours of approved continuing education in child abuse recognition and reporting in the 2 years immediately preceding the application for reactivation as set forth in 23 Pa.C.S. §  6383(b)(3)(ii) (relating to education and training) and in §  16.108(b) (relating to child abuse recognition and reporting—mandatory training requirement).

 (c)  A registrant who has not had clinical contact with patients for 4 years or more shall demonstrate current competency and qualification to hold forth as a naturopathic doctor by demonstrating a passing score on the NPLEX Part II—Core Clinical Science Examination, completed within 12 months of the application to reactivate the registration.

 (d)  Payment of applicable late fees required under section 225 of the Bureau of Professional and Occupational Affairs Fee Act does not preclude the Board from taking disciplinary action for utilizing the title of ‘‘naturopathic doctor,’’ ‘‘doctor of naturopathic medicine,’’ ‘‘registered naturopathic doctor’’ or any other term implying that the individual was currently registered as a naturopathic doctor while holding an inactive or expired registration.

§ 18.906. Display of registration.

 A naturopathic doctor registrant shall prominently display the certificate of registration and evidence of biennial renewal in a publicly accessible location at the registrant’s regular place of business. The registrant shall have evidence of current registration available for inspection by authorized agents of the Board and by persons receiving services when the naturopathic doctor provides services at locations other than the registrant’s regular place of business.

§ 18.907. Acceptable titles and professional designations by registrants; prohibited titles.

 (a)  An individual must have a current, active and unsuspended registration to claim to be, or hold oneself out as, a naturopathic doctor, registered naturopathic doctor, doctor of naturopathic medicine or use any similar title implying that the individual holds a current registration as a naturopathic doctor in this Commonwealth.

 (b)  A naturopathic doctor who uses the designation ‘‘Dr.’’ shall further identify himself as a ‘‘naturopathic doctor,’’ ‘‘registered naturopathic doctor’’ or ‘‘doctor of naturopathic medicine’’ and may not use any term or designation that would imply that the naturopathic doctor is licensed or authorized to practice medicine and surgery, dentistry, podiatry, optometry, psychology, nursing, physical therapy, acupuncture, chiropractic, genetic counseling, athletic training, massage therapy or any other health care profession, unless that individual also holds a current and active authorization to practice the other profession issued by the appropriate licensing authority of this Commonwealth.

§ 18.908. Informed consent and disclosure of financial interests.

 (a)  A naturopathic doctor shall obtain written informed consent from the patient prior to providing naturopathic services to the patient. The informed consent shall include notification to the patient that the naturopathic doctor is not a physician. This subsection shall not apply to registrants who are also currently and actively licensed to practice as a physician in this Commonwealth.

 (b)  A naturopathic doctor shall disclose to patients and prospective patients if the naturopathic doctor receives any commission, rebate, referral fee or similar financial incentive in connection with any marketing activity relating to merchandise.

§ 18.909. Naturopathic records.

 (a)  A naturopathic doctor shall maintain patient records that accurately describe the patient’s concerns, evidence the naturopathic doctor’s plan of service and implementation of service and document the patient’s response to any services provided.

 (b)  All patient records for minors and adults shall be retained for a minimum period of 7 years from the date of the service for which a naturopathic record entry is required. Patient records for minor patients shall also be retained until 1 year after the minor patient reaches majority, even if this means that the naturopathic doctor retains the record for a period of more than 7 years.

 (c)  Upon written request, a naturopathic doctor shall make true, correct and legible copies of the written records of service available to the patient or the person or persons designated by the patient.

 (d)  Payment for naturopathic services rendered may not be required as a condition to making the written records of service available to the patient or the patient’s designee. A naturopathic doctor may require pre-payment of the costs to copy and produce the naturopathic records. The maximum applicable copying and reproduction costs for naturopathic service records shall be the same as those costs applicable to production of health records as annually adjusted by the Secretary of the Department of Health and published in the Pennsylvania Bulletin.

§ 18.910. Advertising.

 (a)  An advertisement by a naturopathic doctor shall contain both of the following:

   (1)  The name of the naturopathic doctor as registered with the Board.

   (2)  The words ‘‘naturopathic doctor,’’ ‘‘doctor of naturopathic medicine,’’ or ‘‘registered naturopathic doctor.’’

 (b)  Advertisements by a naturopathic doctor may not contain any of the following:

   (1)  The word ‘‘physician’’ unless the naturopathic doctor is also currently and actively licensed as a physician or physician assistant in this Commonwealth.

   (2)  Words or phrases indicating or implying that the naturopathic doctor is ‘‘board certified’’ or ‘‘board eligible’’ unless the certification body is also disclosed.

   (3)  Statements containing misrepresentations of facts.

   (4)  Statements that cannot be verified by the Board for truthfulness.

   (5)  Statements likely to mislead or deceive because of their context or because the statements make only a partial disclosure of relevant facts.

   (6)  Statements intended to, or likely to, create false or unjustified expectations of favorable results.

   (7)  Statements containing representations or implications that can reasonably be expected to cause an ordinary prudent person to misunderstand or be deceived.

   (8)  Statements that are untruthful and improbable or contain misstatements, falsehoods, misrepresentations, distorted or fabulous statements as to cures.

   (9)  Statements that misrepresent the nature, characteristics or qualities of merchandise or naturopathic services provided by a naturopathic doctor.

   (10)  Statements that a manifestly incurable condition can be cured or that guarantee a cure of any condition.

   (11)  Statements promoting herbal, natural or dietary supplements as drugs.

   (12)  Statements recommending any modality of service that is inconsistent with the health, safety and welfare of the public.

§ 18.911. Code of Ethics.

 (a)  Naturopathic doctors shall concern themselves primarily with the welfare of the patient.

 (b)  A naturopathic doctor who suffers from a physical, mental or emotional impairment, including substance abuse, that impacts the individual’s ability to practice naturopathic medicine or to provide naturopathic services with reasonable skill and safety to patients shall seek professional treatment and refrain from the practice of naturopathic medicine until the impairment no longer exists or reasonable accommodations can be made.

 (c)  A naturopathic doctor shall:

   (1)  Respect and maintain the privacy and confidentiality of the patient.

   (2)  Disclose the patient’s records or information about the patient only with the patient’s consent or as required by law.

   (3)  Safeguard patient protected health information, including storage and disposal of records.

   (4)  Provide sufficient information to a patient to allow the patient to make an informed decision regarding care, including:

     (i)   The purpose and nature of a naturopathic evaluation or naturopathic service regimen.

     (ii)   Alternatives to naturopathic care.

     (iii)   Side effects and benefits of a proposed naturopathic service regimen.

     (iv)   The estimated cost of naturopathic services.

     (v)   The right of the patient to withdraw from naturopathic services.

   (5)  Maintain professional boundaries, even when the patient initiates crossing the boundaries of the professional relationship.

   (6)  Decline to administer a naturopathic service if the naturopathic doctor believes that the service is contraindicated or unjustified.

   (7)  Make referrals only to registered naturopathic doctors or other qualified and duly licensed health care providers.

   (8)  Inform the patient, other health care professionals and the public of the limitations of naturopathic medicine.

   (9)  Assess the patient to determine if contraindications against naturopathic service exist and refer the patient to an appropriate health care practitioner.

   (10)  At all times respect the patient’s dignity, autonomy and privacy.

   (11)  Cooperate with any lawful investigation conducted by the Board, including:

     (i)   Furnishing information requested as directed by the Board.

     (ii)   Complying with a subpoena.

     (iii)   Responding to a complaint at the request of the Board.

     (iv)   Providing access to relevant patient records.

   (12)  Report to the Board misconduct committed by a naturopathic doctor in the practice of naturopathic medicine or in the provision of naturopathic services.

 (d)  A naturopathic doctor may not:

   (1)  Misrepresent credentials, qualifications or affiliations, and shall attempt to correct others who misrepresent the naturopathic doctor’s credentials, qualifications or affiliations.

   (2)  Knowingly engage in or condone behavior that is fraudulent, dishonest or deceitful.

   (3)  Engage in a marketing activity which conflicts with subsection (c).

   (4)  Perform naturopathic medicine on or provide a naturopathic service to a patient if a contraindication against naturopathic service exists.

   (5)  Intimidate, threaten, influence or attempt to influence any person regarding any violation of law or regulation.

   (6)  Aid or abet any individual violating or attempting to violate any provision of law or regulation.

   (7)  Accept a patient for a naturopathic service, or continue unnecessary service, when the patient cannot be reasonably expected to benefit from the service.

   (8)  Receive remuneration from, or provide remuneration to, or split a fee, for either making or accepting a referral of the patient to or from another health care provider.

   (9)  Make a guarantee or promise about the efficacy of the naturopathic doctor’s practice, particular naturopathic service or the anticipated results of care.

   (10)  Exploit the professional relationship by either of the following:

     (i)   Continuing naturopathic service unnecessarily.

     (ii)   Charging for a naturopathic service not provided or different from what was actually provided.

   (11)  Exploit a relationship with a patient, staff member or student for the naturopathic doctor’s personal advantage including, but not limited to, a personal, sexual, romantic or financial relationship.

   (12)  Engage in sexual misconduct.

   (13)  Provide or perform a naturopathic service at a level beneath the accepted standard of care for a naturopathic doctor which would be normally exercised by the average professional of the same kind in this Commonwealth under the circumstances, including locality and whether the naturopathic doctor is or purports to be a specialist in the area.

 (e)  A naturopathic doctor may not perform or provide naturopathic service that the naturopathic doctor is not qualified to perform, or which is beyond the naturopathic doctor’s education and training.

 (f)  A naturopathic doctor may not assert as a defense to a disciplinary action under section 204 of the NDRA (63 P.S. §  272.204) or §  18.913 (relating to grounds for discipline), the absence of a specific ethical, legal or professional duty in this subsection when the duty is normally exercised by the average professional of the same kind in this Commonwealth under the circumstances, including locality and whether the naturopathic doctor is or purports to be a specialist in the area.

§ 18.912. Sexual misconduct.

 (a)  Sexual exploitation by a naturopathic doctor of a current or former patient, or of an immediate family member of a patient, constitutes unprofessional conduct, is prohibited and subjects the naturopathic doctor to disciplinary action under section 204(8) of the NDRA (63 P.S. §  272.204(8)).

 (b)  Sexual behavior that occurs with a current patient, other than the naturopathic doctor’s spouse, constitutes unprofessional conduct, is prohibited and subjects the practitioner to disciplinary action under section 204(8) of the NDRA.

 (c)  When a naturopathic doctor was involved with the management or directly provided naturopathic services to a patient other than the naturopathic doctor’s spouse for a mental health disorder, any sexual behavior with that patient which occurs prior to the 2-year anniversary of the termination of the professional relationship constitutes unprofessional conduct, is prohibited and subjects the naturopathic doctor to disciplinary action under section 204(8) of the NDRA.

 (d)  A practitioner who engages in conduct prohibited by this section will not be eligible for placement into an impaired professional program in lieu of disciplinary or corrective actions.

 (e)  Consent is not a defense to conduct prohibited by this section.

§ 18.913. Grounds for discipline.

 (a)  The Board shall have the authority to impose disciplinary or corrective measures on a naturopathic doctor or applicant for registration as a naturopathic doctor for the reasons set forth in section 204 of the NDRA (63 P.S. §  272.204) and any of the following:

   (1)  Fraudulently or deceptively obtaining, or attempting to obtain, or using a registration or assisting another in fraudulently or deceptively obtaining or using a registration.

   (2)  Using false, deceptive or misleading advertising.

   (3)  Advertising, practicing or attempting to practice under a name other than the naturopathic doctor’s name as registered with the Board; provided, however, that a naturopathic doctor may advertise utilizing a business name if the advertisement also includes the naturopathic doctor’s name as registered by the Board.

   (4)  Aiding, assisting, employing or advising any unregistered individual to hold himself out in a manner which states or implies the unregistered individual is a naturopathic doctor.

   (5)  Paying or receiving any commission, bonus, kickback or rebate, or engaging in any split-fee arrangement in any form with a licensed physician, organization, agency or other person, either directly or indirectly, for patients referred to other health care providers.

   (6)  Promoting the sale of services, drugs, devices, appliances or goods to a patient so as to exploit the patient for financial gain.

   (7)  Failing to keep written records justifying the course of service of a patient.

   (8)  Failing to disclose the contents of merchandise or the nature and description of naturopathic services recommended, provided or offered to a patient.

   (9)  Failing to cooperate with a lawful investigation of the Board.

 (b)  When the Board is empowered to take disciplinary or corrective action under the provisions of the NDRA, the Board’s regulations or other statutory or regulatory authority, the Board may impose one or more of the following disciplinary or corrective actions as set forth in section 206 of the NDRA (63 P.S. §  272.206), section 42 of the act (63 P.S. §  422.42) and 63 Pa.C.S. §  3108 (relating to civil penalties):

   (1)  Deny the application for registration.

   (2)  Administer a public reprimand with or without probation.

   (3)  Revoke, suspend, limit or otherwise restrict a registration.

   (4)  Require the registrant to submit to the care, counseling or treatment of a physician or a psychologist designated by the Board.

   (5)  Require the registrant to take refresher educational courses or demonstrate passage of the NPLEX examination, or both.

   (6)  Stay enforcement of any suspension and place the registrant on probation with the right to vacate the probationary order for noncompliance.

   (7)  Impose a civil penalty of up to $1,000 in accordance with the NDRA.

   (8)  Impose a civil penalty of up to $10,000 in accordance with 63 Pa.C.S. §  3108(b); provided, however, that the Board will not impose a civil penalty under the NDRA and also impose a civil penalty under 63 Pa.C.S. §  3108(b) for the same violation, as prohibited by 63 Pa.C.S. §  3108(c)(2).

   (9)  Impose the costs of investigation underlying the disciplinary action.

Cross References

   This section cited in 49 Pa. Code §  18.903 (relating to application for naturopathic doctor registration); and 49 Pa. Code §  18.911 (relating to Code of Ethics).



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