RULES AND REGULATIONS
Title 49—PROFESSIONAL AND VOCATIONAL STANDARDS
STATE BOARD OF MEDICINE
[ 49 PA. CODE CHS. 16 AND 18 ]
[40 Pa.B. 250]
[Saturday, January 9, 2010]
The State Board of Medicine (Board) hereby amends §§ 16.11, 16.13, 16.15, 18.11—18.13a, 18.15, 18.15a and 18.18, to read as set forth in Annex A.
Description and Need for the Rulemaking
The act of November 29, 2006 (P. L. 1625, No. 186) (Act 186) amended the Acupuncture Registration Act (act) (63 P. S. §§ 1801—1806.1) to authorize an acupuncturist or practitioner of Oriental medicine (hereinafter referred to collectively as acupuncturists) to treat a patient's condition through acupuncture or the use of herbal therapy for up to 60 days without the condition first being diagnosed by a physician, dentist or podiatrist. See 63 P. S. § 1803.1. Subsequently, after the Board published proposed rulemaking intending to implement section 3.1 of the act, the act was amended and renamed as the Acupuncture Licensure Act by the act of October 8, 2008 (P. L. 1092, No. 91) (Act 91). Act 91 revised the act solely to refer to licensure, rather than registration, of acupuncturists. This final rulemaking implements both Act 186 and Act 91.
Summary of Comments and Responses to Proposed Rulemaking
The Board published notice of proposed rulemaking at 38 Pa.B. 2059 (May 3, 2008) with a 30-day public comment period. The Board received written comments from the Association for Professional Acupuncture in Pennsylvania, endorsing the proposed rulemaking as published. The Board received comments from the House Professional Licensure Committee (HPLC) and the Independent Regulatory Review Commission (IRRC) as part of their review of proposed rulemaking under the Regulatory Review Act (71 P. S. §§ 745.1—745.12). The Board received no comments from the Senate Consumer Protection and Professional Licensure Committee (SCP/PLC).
The HPLC noted that the proposed regulation would require a physician, dentist or podiatrist to diagnose a condition past 60 calendar days of acupuncture treatment. The HPLC then asked if a diagnosis is the only requirement, or if it is intended that a physician, dentist or podiatrist give permission for continued treatment. The diagnosis is the only requirement, and the Board does not intend that a physician, dentist or podiatrist give permission for continued acupuncture treatment.
The HPLC also noted that § 18.15a(b) (relating to scope of practice of acupuncturists and practitioners of Oriental medicine) specifically addresses authorization for use of herbal therapy by practitioners of Oriental medicine. The HPLC suggested that the provision in proposed § 18.15(a)(7) (relating to practice responsibilities of acupuncturist and practitioner of Oriental medicine who is not a medical doctor) concerning herbal therapy would be better placed in § 18.15a. The Board agrees and has moved the reference to dispensing or administering therapeutic herbs to § 18.15a(b).
IRRC first questioned the Board's specific citation to its statutory authority in publishing the proposed rulemaking. The Board's statutory authority is section 3(b) of the act (63 P. S. §§ 1803(b)) and section 8 of the Medical Practice Act of 1985 (63 P. S. § 422.8), and not generally Act 186.
IRRC noted that by using the phrase ''within 60 calendar days,'' proposed § 18.15(a)(4) would permit an acupuncturist to wait the full 60 days of treatment before referring a patient for care by a physician, dentist or podiatrist. Additionally, that phrase would appear to limit the subsection's requirement for referral to apply only during the first 60 days of treatment. IRRC recommended deleting the phrase ''within 60 days'' and requiring an acupuncturist to refer a patient as soon as it is appropriate and necessary to protect the patient. The Board agrees with this recommendation and has revised the rulemaking accordingly.
In reviewing this rulemaking, the Board noted a discrepancy in its definition of ''supplemental techniques'' and its use of that term elsewhere in the regulations. In § 18.11 (relating to definitions), ''supplemental techniques'' is defined to include herbal therapy. Section 18.13a(a) (relating to requirements for licensure as a practitioner of Oriental medicine) requires an acupuncturist who intends to use herbal therapy to become licensed by the Board as a practitioner of Oriental medicine. Section 18.15a(a) authorizes an acupuncturist to practice acupuncture and use supplemental techniques, but not use herbal therapy, and section 18.15a(b) authorizes a practitioner of Oriental medicine to practice acupuncture and use supplemental techniques including herbal therapy. To avoid any confusion as to whether an acupuncturist may use herbal therapy, the Board has amended the definition of ''supplemental techniques'' in § 18.11 to omit reference to the use of herbal therapy.
Additionally, the Board noted that the heading of § 18.15 should remain in the singular, despite the references to both an acupuncturist and a practitioner of Oriental medicine. In § 18.15(a)(2) and (3), the rulemaking should address an acupuncturist or practitioner of Oriental medicine who is not a physician treating the patient's symptoms, rather than the patient's condition. Similarly in § 18.15(a)(7), the rulemaking is revised to provide that the acupuncturist or practitioner of Oriental medicine may not diagnose an ailment or condition, rather than medically diagnose, as that phrase is redundant.
Finally, the Board has revised §§ 16.11(b) and (c), 16.13(d), 16.15(a), 18.11, 18.12, 18.13(a) and (b), 18.13a, and 18.18 to refer to acupuncturist licensure, rather than registration, as provided by Act 91.
Fiscal Impact and Paperwork Requirements
The final-form rulemaking will have no adverse fiscal impact on the Commonwealth or its political subdivisions and will impose no additional paperwork requirements upon the Commonwealth, political subdivisions or the private sector.
The final-form rulemaking will become effective upon publication in the Pennsylvania Bulletin.
The final-form rulemaking is authorized under section 3(b) of the Acupuncture Licensure Act and section 8 of the Medical Practice Act of 1985.
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on April 21, 2008, the Board submitted a copy of the notice of proposed rulemaking, published at 38 Pa.B. 2059, to IRRC and to the HPLC and the SCP/PLC for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC, the HPLC and the SCP/PLC were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Board has considered all comments received from IRRC, the HPLC, the SCP/PLC and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on November 18, 2009, the final-form rulemaking was approved by the HPLC. On December 9, 2009, the final-form rulemaking was deemed approved by the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on December 10, 2009, and approved the final-form rulemaking.
Persons who require additional information about the final-form rulemaking should submit inquiries to Regulatory Unit Counsel, Department of State, P. O. Box 2649, Harrisburg, PA 17105-2649, (717) 783-1400, or firstname.lastname@example.org.
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) and regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2 (relating to notice of proposed rulemaking required; and adoption of regulations).
(2) A public comment period was provided as required by law and comments were considered.
(3) The amendments to this final-form rulemaking do not enlarge the scope of proposed rulemaking published at 38 Pa.B. 2059.
(4) The final-form rulemaking adopted by this order is necessary and appropriate for the administration of the act and the Medical Practice Act of 1985.
The Board, acting under its authorizing statutes, orders that:
(a) The regulations of the Board, 49 Pa. Code Chapters 16 and 18, are amended by amending §§ 16.11, 16.13, 16.15, 18.11—18.13a, 18.15, 18.15a and 18.18 to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(b) The Board shall submit a copy of this order and Annex A to the Office of Attorney General and the Office of General Counsel for approval as required by law.
(c) The Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(d) The final-form rulemaking shall take effect upon publication in the Pennsylvania Bulletin.
OLLICE BATES, Jr., M. D.,
(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 39 Pa.B. 7271 (December 26, 2009).)
Fiscal Note: Fiscal Note 16A-4924 remains valid for the final adoption of the subject regulations.
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 16. STATE BOARD OF MEDICINE—GENERAL PROVISIONS
Subchapter B. GENERAL LICENSE, CERTIFICATION AND REGISTRATION PROVISIONS
§ 16.11. Licenses, certificates and registrations.
(a) The following medical doctor licenses are issued by the Board:
(1) License without restriction.
(2) Institutional license.
(3) Extraterritorial license.
(4) Graduate license.
(5) Temporary license.
(6) Interim limited license.
(b) The following nonmedical doctor licenses and certificates are issued by the Board:
(1) Nurse-midwife license.
(2) Nurse-midwife certificate of prescriptive authority.
(3) Physician assistant license.
(4) Acupuncturist license.
(5) Practitioner of Oriental medicine license.
(c) The following registrations are issued by the Board:
(1) Registration as a supervising physician of a physician assistant.
(2) Biennial registration of a license without restriction.
(3) Biennial registration of an extraterritorial license.
(4) Biennial registration of a midwife license.
(5) Biennail registration of a physician assistant license.
(6) Biennial registration of a drugless therapist license.
(7) Biennial registration of a limited license-permanent.
(8) Biennial registration of an acupuncturist license.
(9) Biennial registration of a practitioner of Oriental medicine license.
§ 16.13. Licensure, certification, examination and registration fees.
* * * * *
(d) Acupuncturist licenses:
(1) Acupuncturist license:
Biennial renewal $40
(2) Practitioner of Oriental medicine license:
Biennial renewal $40
* * * * *
§ 16.15. Biennial registration; inactive status and unregistered status.
(a) A person licensed, certified or registered by the Board, shall register biennially to retain the right to engage in practice unless specifically exempted within this section. Initial registration shall automatically occur when the license, certificate or registration is issued.
* * * * *
CHAPTER 18. STATE BOARD OF MEDICINE—PRACTITIONERS OTHER THAN MEDICAL DOCTORS
Subchapter B. LICENSURE AND PRACTICE OF 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:
(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 offered or recognized by the Board to test whether an individual has accumulated sufficient academic knowledge with respect to the practice of acupuncture and herbal therapy to qualify for the privilege of practicing as an acupuncturist or as a practitioner of Oriental medicine. The Board recognizes the NCCAOM component examinations in acupuncture and sterilization procedures as the examination for registration as an acupuncturist and the NCCAOM examination component in Chinese herbology as the examination for registration as a practitioner of Oriental medicine.
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 accupuncture by the Board.
Chinese herbology—The study of the use of herbs in the Oriental medicine tradition.
Herbal therapy—The application of Chinese herbology to the treatment of acupuncture patients.
NCCAOM—The National Certification Commission for Acupuncture and Oriental Medicine.
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.
§ 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.
§ 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 obtained a passing grade on an acupuncture examination or has been certified by NCCAOM. 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 secured a score of 550 on the test of English as a Foreign Language (TOEFL).
(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. For the fee amount, see § 16.13 (relating to licensure, certification, examination and registration fees).
(c) Prior to January 1, 1988, the Board will register as an acupuncturist a medical doctor who satisfies the requirements of subsection (a), (b) or the following:
(1) Has at least 3 years of acupuncture practice—a minimum of 500 patient visits per year—documented to the satisfaction of the Board.
(2) Submits an application to register as an acupuncturist accompanied by the required fee. For the fee amount, see § 16.13.
§ 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 Chinese herbology and has passed the NCCAOM examination component on Chinese herbology.
(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 or Oriental medicine if the acupuncturist can demonstrate one of the following:
(1) Successful completion of a Chinese 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 Chinese 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 subsection does not apply to a medical doctor licensed as an acupuncturist nor does it restrict the practice of medicine by a medical doctor.
§ 18.15. Practice responsibilities of acupuncturist and practitioner of Oriental medicine who is not a medical doctor.
(a) Responsibilities to patient. In relation to the acupuncture patient, the acupuncturist and the practitioner of Oriental medicine:
(1) Shall perform an acupuncture or Oriental medicine evaluation and develop an acupuncture or Oriental medicine treatment plan.
(2) May treat the patient's symptoms without the condition being diagnosed by a physician, dentist or podiatrist for 60 calendar days from the date of the first treatment.
(3) May treat the patient's symptoms 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 to a physician, dentist or podiatrist, as appropriate to the patient's condition, if the acupuncturist or practitioner of Oriental medicine determines that further acupuncture or Oriental medicine 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).
(b) Identification of acupuncturist or practitioner of Oriental medicine. An acupuncturist who is not a medical doctor shall wear a tag or badge with lettering clearly visible to the patient bearing the acupuncturist's name and the title ''acupuncturist'' or ''practitioner of Oriental medicine,'' as appropriate. The use of the word doctor on this tag or badge is prohibited.
§ 18.15a. Scope of practice of acupuncturists and practitioners of Oriental medicine.
(a) An acupuncturist may practice acupuncture and use supplemental techniques but may not use herbal therapy.
(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.
(c) This subsection does not limit the scope of practice of a medical doctor who is registered as an acupuncturist.
§ 18.18. Disciplinary and corrective measures.
(a) The Board may refuse, revoke, suspend, limit or attach conditions to the license of an acupuncturist or practitioner of Oriental medicine for engaging in conduct prohibited under section 41 of the act (63 P. S. § 422.41) for Board-regulated practitioners.
(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.
[Pa.B. Doc. No. 10-57. Filed for public inspection January 8, 2010, 9:00 a.m.]
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