PROPOSED RULEMAKING
STATE BOARD
OF MEDICINE
[ 49 PA. CODE CH. 18 ]
Acupuncture Registration
[38 Pa.B. 2059]
[Saturday, May 3, 2008]The State Board of Medicine (Board) proposes to amend § 18.15 (relating to practice responsibilities of acupuncturist who is not a medical doctor), to read as set forth in Annex A.
A. Effective Date
The amendments will be effective upon publication as final-form rulemaking in the Pennsylvania Bulletin.
B. Statutory Authority
The act of November 29, 2006 (P. L. 1625, No. 186) (Act 186) amended the Acupuncture Registration Act (act) (63 P. S. §§ 1801--1806) to authorize an acupuncturist or practitioner of Oriental medicine (hereinafter referred to collectively as acupuncturists) to treat a patient's condition though acupuncture or by dispensing or administering medicinal herbs for up to 60 days without the patient's condition first being diagnosed by a physician, dentist or podiatrist. See 63 P. S. § 1803.1. In addition, section 21 of the Medical Practice Act of 1985 (63 P. S. § 422.21), provides for the various levels of required medical doctor involvement with the care of patients who are being treated by nonphysicians.
C. Background and Purpose
This proposed rulemaking seeks to amend the Board's existing regulations to implement the 60-day direct access provision of Act 186 and provide for patient safety by establishing protocols for a cooperative relationship between the patient's acupuncturist and the patient's treating physician, as applicable.
Act 186 contains two substantive provisions regarding the practice of acupuncture:
1. It gives acupuncturists the authority to treat patients for 60 days without any physician involvement.
2. It deletes from the act the statutory requirement that a patient obtain a referral or prescription for acupuncture services and substitutes a requirement for a medical examination and diagnosis if treatment will continue beyond 60 days.
The 60-day access provision is self-executing. However, the provision dealing with physician involvement keeps open the question as to what responsibilities the physician still has under the Medical Practice Act regarding to the needs of the patient if the patient has contra-indications for acupuncture or herbal treatments. Similarly, the act does not provide for the acupuncturists responsibilities to their patient when it is apparent that despite acupuncture treatment the patient's condition is worsening. Accordingly, it is appropriate for the Board to establish regulations to address the question as to the professionals' obligation to safeguard the well being of their joint patients.
D. Description of Amendments
The rulemaking proposes to amend § 18.15 to comport with Act 186 to authorize an acupuncturist or practitioner of Oriental medicine to treat a patient's condition for up to 60 days without the condition first being diagnosed by a physician, dentist or podiatrist. The rulemaking also proposes to amend § 18.15 to provide for the responsibilities of the acupuncturist regarding the coordination of patient care with the patient's physician, dentist or podiatrist.
Section 18.15 would be amended throughout to add ''practitioners of Oriental medicine'' consistent with the Board's prior final rulemaking published at 37 Pa.B. 1644 (April 14, 2007).
Subsection (a)(1) would require acupuncturists to perform an evaluation of the patient and develop an acupuncture or Oriental medicine treatment plan.
Subsection (a)(2) would provide for the acupuncturist to treat patients for 60 calendar days without the patient's condition being first diagnosed by a physician, dentist or podiatrist.
Subsection (a)(3) would permit continued acupuncture or Oriental medicine treatment beyond 60 calendar days if the patient obtains an examination and diagnosis from a physician, dentist or podiatrist.
Subsection (a)(4) would require acupuncturists to refer a patient within the 60 calendar days to a physician, dentist or podiatrist, as appropriate to the patient's condition, if acupuncture or Oriental medicine treatment is contraindicated for the patient or if the patient's condition worsens.
Subsection (a)(4) would require the acupuncturist to consult with the patient's physician, dentist, podiatrist or other health care practitioner at the patient's request.
Subsection (a)(5) would require the acupuncturist to cooperate with the patient's physician, dentist or podiatrist regarding the coordination of the patient's care, and to comply with restrictions or conditions as directed by the patient's physician, dentist or podiatrist.
Subsection (a)(6) would prohibit acupuncturists from diagnosing a physical or mental ailment or condition or prescribing or dispensing a drug. The subsection would allow practitioners of Oriental medicine to dispense and administer therapeutic herbs that contain ingredients that are similar or equivalent to active ingredients in drugs as classified by the Food and Drug Administration. The subsection would also permit the use of diagnostic billing codes used for payment and reimbursement.
Subsection (a)(7) would require compliance with sterilization standards relative to aseptic practices.
Subsection (a)(8) would require that patient records be maintained in a manner consistent with the Board's recordkeeping regulation in § 16.95 (relating to medical records).
Subsection (b) would be amended to delete outdated provisions pertaining to supervision of acupuncturists. The requirement that acupuncturists identify themselves as such is retained.
E. Compliance
The Board met with representatives of the Pennsylvania Association for Professional Acupuncture (Association). The comments from the Association were primarily technical in nature and were incorporated into this proposed rulemaking. The Association also commented on the language requiring referral if the patient's condition worsens. The Association's comments expressed concern that the patient's perception of his condition may not be accurate from clinical perspective. In recognition that the initial determination of the progress and appropriateness of treatment is a professional one, the Board has made it clear to the Association that it is the acupuncturist who is responsible for making that determination.
The law firm of Kalegredis, Sansweet, Dearden and Burke, LTD, submitted written comments. The comments asserted that requiring the acupuncturist to refer patients to other health care practitioners was problematic because such a requirement was not contemplated by Act 186 and because ''worsening'' of the patient's condition was subjective and undefined. The Board disagrees. Act 186 does not preclude the Board from adopting regulations giving effect to other related provisions of law, including section 21 of the Medical Practice Act of 1985, which provides for necessary medical doctor involvement with health care being administered by persons other than medical doctors. Moreover, one need only examine the warning labels of over-the-counter medications to appreciate that the term ''worsens'' is a commonly understood concept by patients as well as health care practitioners. Indeed, during Board meetings at which the proposal was being discussed, when asked by the Board how an acupuncturist knows when the acupuncture treatment being provided is contraindicated, the acupuncturist representatives of the Pennsylvania Association for Professional Acupuncture stated that the patient gets ''worse.'' Lastly, this provision is consistent with existing § 18.15(b)(1), which this proposal would merely relocate to § 18.15(a).
Kalegredis, Sansweet, Dearden and Burke, LTD, also recommended that the Board allow for the use of diagnostic billing codes in § 18.15(a)(6). The Board agrees that this is a helpful clarification and has incorporated it into this proposed rulemaking. Kalegredis, Sansweet, Dearden and Burke, LTD, also recommended that the rulemaking clarify that practitioners of Oriental medicine may use other supplemental techniques. The Board does not believe this is necessary because under the Board's regulations all practitioners of Oriental medicine are acupuncturists, with the additional authority of being authorizedto provide Chinese herbal therapy. Accordingly, practitioners of Oriental medicine may use all the modalities that acupuncturists are authorized to use without further revision to the regulations.
Kalegredis, Sansweet, Dearden and Burke, LTD, also suggested that requiring acupuncturists to maintain records in a manner consistent with the Board's regulations in § 16.95 is inappropriate because that section refers to physicians. The Board believes the comment misapprehends that the use of the phrase ''consistent with'' qualifies the reference to § 16.95. The Board has not incorporated § 16.95 by reference, but rather requires the acupuncturist to maintain those records developed during the acupuncturist-patient relationship in a manner so that the records are accurate, legible, complete and accessible to patients. The Board believes it unnecessary to recreate these requirements for each Board-regulated practitioner. The Board has plans for future rulemaking that will amend and make more generic certain regulations that are of common application to all Board-regulated practitioners. This rulemaking is consistent with that plan.
F. Fiscal Impact and Paperwork Requirements
There is no adverse fiscal impact or paperwork requirement imposed on the Commonwealth, political subdivision or the private sector.
G. Sunset Date
The Board continuously monitors its regulations. Therefore, no sunset date has been assigned.
H. Regulatory Review
Under section 5(a) of the Regulatory Review Act (act) (71 P. S. § 745.5(a)), on April 21, 2008, the Board submitted a copy of this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and the Chairpersons of the House Professional Licensure Committee and the Senate Consumer Protection and Professional Licensure Committee. A copy of this material is available to the public upon request.
Under section 5(g) of the act, IRRC may convey any comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections shall specify the regulatory review criteria that have not been met. The act specifies detailed procedures for review, prior to final publication of the rulemaking, by the Board, the General Assembly and the Governor of comments, recommendations and objections raised.
I. Public Comment
Interested persons are invited to submit written comments, recommendations or objections regarding the proposed rulemaking to Gerald S. Smith, Senior Counsel in Charge, Department of State, P. O. Box 2649, Harrisburg, PA 17105-2649 within 30 days following publication for the proposed regulation in the Pennsylvania Bulletin. Refer to 16A-4924: Acupuncture when submitting comments.
CHARLES D. HUMMER, Jr., M. D.,
ChairpersonFiscal Note: 16A-4924. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
CHAPTER 18. STATE BOARD OF MEDICINE--PRACTITIONERS OTHER THAN MEDICAL DOCTORS
Subchapter B. REGISTRATION AND PRACTICE OF ACUPUNCTURISTS AND PRACTITIONERS OF ORIENTAL MEDICINE § 18.15. Practice responsibilities of acupuncturist and practitioner of Oriental medicine who [is] are not [a] medical [doctor] doctors.
(a) Responsibilities to patient. In relation to the acupuncture patient, the acupuncturist [shall comply with the following] and the practitioner of Oriental medicine:
(1) [Received, in writing, from the acupuncturist supervisor, approval to initiate acupuncture treatment] Shall perform an acupuncture or Oriental medicine evaluation and develop an acupuncture or Oriental medicine treatment plan.
(2) [Comply strictly with conditions or restrictions that may be placed on the course of acupuncture treatment by the acupuncturist supervisor] May treat the patient's condition 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 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, within 60 calendar days from the date of first treatment, 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 condition has 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 regarding the coordination of the patient's care, and comply with restrictions or conditions as directed by the physician, dentist or podiatrist.
(7) [Not] May not medically diagnose a physical or mental ailment or condition or prescribe or dispense a drug. 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 Food and Drug Administration. This provision does not prohibit the use of diagnostic billing codes for billing or reimbursement purposes.
[(4) Comply] (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) [Responsibility to acupuncturist supervisor. In relation to the acupuncturist supervisor, the acupuncturist shall comply with the following:
(1) Consult promptly with the acupuncturist supervisor regarding a new ailment or condition or a worsened ailment or condition of an acupuncture patient.
(2) Consult with the acupuncturist supervisor upon request of either the acupuncturist supervisor or the acupuncture patient.
(3) Practice acupuncture only under the general supervision of an acupuncturist supervisor.
(c) Scope of acupuncturist's responsibility.
(1) An acupuncturist is responsible solely for acupuncture evaluation and acupuncture treatment. The medical diagnosis is the responsibility of the acupuncturist supervisor.
(2) An acupuncturist is not required to practice acupuncture in the physical presence of the acupuncturist supervisor or at the location where the acupuncturist supervisor provides medical services. Where the acupuncturist may provide acupuncture services, and whether the acupuncturist may provide acupuncture services without the acupuncture supervisor being physically present, shall be determined by the acupuncture supervisor.
(d)] 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 [his] 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.
[Pa.B. Doc. No. 08-831. Filed for public inspection May 2, 2008, 9:00 a.m.]
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