TITLE 4. PROFESSIONS AND OCCUPATIONS
CHAPTER 38. BOARD OF HOMEOPATHIC MEDICAL EXAMINERS
Supp. 07-3
(Authority: A.R.S. § 32-2904 et seq.)
ARTICLE 1. GENERAL
Section
R4-38-101. Definitions
R4-38-102. Additional Requirements for Applicants Graduated from an Unapproved School of Medicine
R4-38-103. Approval of Postgraduate Coursework
R4-38-104. Approval of Preceptorship
R4-38-105. Fees
R4-38-106. Examinations
R4-38-107. Waiver of Written Examination
R4-38-108. Notification of Address Changes
R4-38-109. Experimental Forms of Diagnosis and Treatment
R4-38-110. Repealed
R4-38-111. Peer Review
R4-38-112. Registering Use of Experimental Forms of Diagnosis and Treatment
R4-38-113. Chelation Therapy Practice Requirements
R4-38-114. Rehearing or Review of Decision
R4-38-115. Use of Title and Abbreviation
ARTICLE 2. DISPENSING OF DRUGS BY
HOMEOPATHIC PHYSICIANS
Section
R4-38-201. Definitions
R4-38-202. General Provisions
R4-38-203. Repealed
R4-38-204. Repealed
R4-38-205. Repealed
R4-38-206. Packaging
ARTICLE 3. EDUCATION, SUPERVISION, AND DELEGATION STANDARDS FOR REGISTRATION
OF MEDICAL ASSISTANTS BY HOMEOPATHIC PHYSICIANS
Section
R4-38-301. Definitions
R4-38-302. Approved Formal Educational Programs
R4-38-303. Supervision of Formally Educated Assistants
R4-38-304. Approved Practical Educational Programs
R4-38-305. Supervision of Practically Trained Assistants
R4-38-306. Restrictions on Delegated Procedures
R4-38-307. Unprofessional Conduct
R4-38-308. Registration of Medical Assistants and Practical Educational Programs
R4-38-309. Multiple Supervisors
R4-38-310. Previously Licensed Practitioners
R4-38-311. Deadlines for Compliance with Rules
ARTICLE 4. APPLICATION AND RENEWAL PROCESS; TIME-FRAMES
Article 4, consisting of Sections R4-38-401 thru R4-38-403, adopted effective September 24, 1998 (Supp. 98-3).
Section
R4-38-401. Definitions
R4-38-402. Application; Initial License, Permit, or Registration
R4-38-403. Application; Renewal of License, Permit, or Registration
ARTICLE 1. GENERAL
R4-38-101. Definitions
In addition to the definitions at A.R.S. § 32-2901, in this Chapter:
1. "Beneficial clinical usage" means that usage results of a therapy modality or treatment are documented by:
a. Clinical reports from national or international organizations;
b. Professionally recognized publications of clinical indications and contraindications;
c. National or international instructional courses providing training in the use of the therapy modality, or treatment; or
d. Professional peer review presentations of physicians' usage results with the therapy modality or treatment at local, county, state, national or international meetings.
2. "Classical homeopathy" means a system of medical practice expounded by Samuel Hahnemann in the Organon of Medicine that treats a disease by the administration of minute doses of a remedy that would in healthy persons produce symptoms of the disease treated.
3. "Complex homeopathy" means a system of medical practice that combines one or more homeopathic remedies that are not described in the Organon of Medicine.
4. "EAV" means electric acupuncture according to Reinhard Voll.
5. "Fifth Pathway program" means an academic program created by the Council on Medical Education of the American Medical Association specifically for American medical students studying abroad.
6. "Generally accepted experimental criteria in homeopathy" means:
a. A protocol in which a therapy modality or treatment is administered in the smallest amount necessary to stimulate a healing response with a minimum of clinical aggravation of symptoms or side effects;
b. A process of recording the clinical efficacy of a therapy modality or treatment reflected by measurements of symptom aggravation or improvement, laboratory testing, and changes in physiologic functioning; or
c. A process by which innovative diagnostic procedures and devices are analyzed and evaluated according to their ability to assist a physician in assessing the degree of electrical resistance or conduction disturbance in the totality of a patient's presenting signs, symptoms, and physiologic responses and predict or monitor the totality of the patient's responses to a therapy modality or treatment.
7. "Homeopathic indication" means a recognized standard of practice of homeopathic practitioners that describes a sign, symptom, and physical finding that leads to the recommendation of a particular substance or therapeutic procedure.
8. "Metal poisoning" means a level of toxic metals present in a patient that in the professional judgment of a licensee is inconsistent with the patient's ability to achieve optimal health.
9. "Proving method of administration" means testing a homeopathic drug on healthy volunteers by recording, compiling, and organizing symptoms that are developed into a repertory.
10. "Repertory" means a compilation, usually in book form, of information categorized by the different systems of the body and providing an index of symptoms and a listing of corresponding homeopathic remedies.
11. "Rubric" means a guiding symptom leading to a homeopathic remedy.
Historical Note
Adopted effective June 3, 1988 (Supp. 88-2). Heading amended effective February 7, 1995 (Supp. 95-1). Section repealed; new Section made by final rulemaking at 11 A.A.R. 2008, effective July 2, 2005 (Supp. 05-2).
R4-38-102. Additional Requirements for Applicants Graduated from an Unapproved School of Medicine
In addition to the requirements for a license prescribed in A.R.S. § 32-2912, an applicant who has not graduated from an approved school of medicine shall meet the following:
1. Hold a standard certificate issued by the Educational Council for Foreign Medical Graduates; or
2. Complete a Fifth Pathway program of one academic year of supervised clinical training under the direction of an approved school of medicine in the United States and upon completion of the Fifth Pathway program complete a 24-month internship, residency, or clinical fellowship program accredited by the Accreditation Council on Graduate Medical Education (ACGME).
Historical Note
Adopted effective June 3, 1988 (Supp. 88-2). Section repealed; new Section made by final rulemaking at 11 A.A.R. 2008, effective July 2, 2005 (Supp. 05-2).
R4-38-103. Approval of Postgraduate Coursework
A. An applicant for licensure who does not have a degree of doctor of medicine in homeopathy shall identify on a form supplied by the Board completion of at least 300 hours of formal postgraduate education in one or more of the treatment modalities specified in subsections (C)(1) through (6) with at least 40 hours of the 300-hour requirement in a course of classical homeopathy. To receive credit for formal postgraduate coursework, the applicant shall submit the following with the application:
1. A statement showing completion of the coursework and a brief description of the content; and
2. A certificate of attendance showing evidence of the number of hours successfully completed.
B. The Board shall approve a postgraduate course if the course content provides training in one or more of the treatment modalities specified in subsections (C)(1) through (6), the educational qualifications of the instructors demonstrate sufficient knowledge of the subject matter, and the sponsor is recognized within the homeopathic, osteopathic, or medical profession as a provider of postgraduate training and continuing education. The Board shall approve a course of classical homeopathy if the course includes case-taking, repertory use, materia medica, philosophy and history of homeopathy, acute remedies, constitutional prescribing, posology, homeopathy prescription policy, and remedy handling policy.
C. An applicant who wishes to practice a specific treatment modality listed in subsections (C)(1) through (6) shall demonstrate proficiency in the modality by completing the indicated number of postgraduate course hours or certification by the indicated credentialing authority.
1. Acupuncture:
a. Classical acupuncture:
i. Certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM), or
ii. Completing at least 220 hours of postgraduate courses recognized by the American Academy of Medical Acupuncture or other sponsor approved by the Board that provides equivalent training.
b. Electro-diagnosis: Completing at least 50 hours of postgraduate courses in electro-diagnosis that are approved by the Board.
2. Chelation therapy: Completing at least 16 hours of postgraduate courses offered by the American Board of Clinical Metal Toxicology, American College of Alternative Medicine, International College of Integrative Medicine, or the American Academy of Environmental Medicine or other sponsor approved by the Board that provides equivalent training.
3. Classical homeopathy: Completing at least 90 hours of formal postgraduate courses in classical homeopathy approved by the Board, or whose sponsor is recognized by the Council on Homeopathic Education, the American Institute of Homeopathy, the American Board of Homeotherapeutics, the Homeopathic Association of Naturopathic Physicians or the Council for Homeopathic Certification.
4. Complex homeopathy and electro-therapeutics, EAV and related: Completing at least 90 hours of formal postgraduate courses in complex homeopathy approved by the Board, or whose sponsor is recognized by the Council on Homeopathic Education, the American Institute of Homeopathy, the American Board of Homeotherapeutics, the Homeopathic Association of Naturopathic Physicians, or the Council for Homeopathic Certification.
5. Neuromuscular integration:
a. Completing a residency or fellowship in physical medicine or graduation from an osteopathic medical school; or
b. Completing at least 220 hours of formal postgraduate courses in neuromuscular integration therapies that are approved by the Board.
6. Orthomolecular therapy and nutrition: completing at least 300 hours of postgraduate courses in orthomolecular therapy and nutrition approved by the Board.
Historical Note
Adopted effective June 3, 1988 (Supp. 88-2). Section repealed; new Section made by final rulemaking at 11 A.A.R. 2008, effective July 2, 2005 (Supp. 05-2).
R4-38-104. Approval of Preceptorship
Instead of evidence of formal postgraduate courses, an applicant may qualify for licensure based on completion of a preceptorship conducted by a preceptor qualified to provide instruction in one or more of the treatment modalities listed in A.R.S. § 32-2901(22) by submitting with the application the following:
1. A notarized affidavit from each preceptor on the preceptor's letterhead attesting to:
a. The educational qualifications of the preceptor to include the number of years the preceptor has been conducting preceptorships;
b. The dates of the preceptorship;
c. An outline of the training conducted and each treatment modality involved in the training;
d. The number of hours of didactic and clinical training in each treatment modality; and
e. The general nature of the services performed during the training.
2. A summary from the applicant of each preceptorship including:
a. The name of each preceptor;
b. The treatment modalities included in each preceptorship;
c. The total number of hours claimed instead of formal postgraduate courses.
Historical Note
Adopted effective February 22, 1988 (Supp. 88-1). Amended effective January 27, 1995. Amended effective February 7, 1995 (Supp. 95-1). Amended effective November 12, 1996 (Supp. 96-4). Section repealed; new Section made by final rulemaking at 11 A.A.R. 2008, effective July 2, 2005 (Supp. 05-2).
R4-38-105. Fees
The Board shall charge the following fees according to A.R.S. §§ 32-2914 and 32-2916:
1. Application for license: $ 550.00
2. Issuance of initial license: $ 250.00
3. Annual renewal of license: $ 975.00
4. Late renewal penalty: $ 350.00
5. Application for dispensing permit: $ 200.00
6. Annual renewal of dispensing permit: $ 200.00
7. Locum tenens registration application: $ 200.00
8. Locum tenens registration issuance: $ 100.00
9. Application for registration to conduct a
practical education course for supervised
medical assistants: $ 150.00
10. Annual renewal of registration to conduct
a practical education course: $ 50.00
11. Initial application for supervision of medical
assistant: $ 200.00
12. Triennial renewal of supervision of medical
assistant: $ 50.00
13. Annual renewal for registration of medical
assistant: $ 200.00
14. Annual directory: $ 25.00
15. Copies, per page: $ 0.25
16. Copies, per audio tape $ 35.00
17. Copies, per 1.44 M computer disk: $ 100.00
18. Mailing lists - non-commercial (per name) $ 0.05
19. Mailing lists - commercial (per name) $ 0.25
20. Mailing list labels (per name) $ 0.30
21. Copy of statutes or rules, each $ 5.00
Historical Note
Adopted effective June 3, 1988 (Supp. 88-2). Section repealed; new Section made by final rulemaking at 11 A.A.R. 2008, effective July 2, 2005 (Supp. 05-2). Amended by emergency rulemaking at 12 A.A.R. 4894, effective December 4, 2006 for 180 days (Supp. 06-4). Emergency expired. Amended by final rulemaking at 13 A.A.R. 2924, effective August 7, 2007 (Supp. 07-3).
R4-38-106. Examinations
A. The examination for a license consists of three parts:
1. A timed written examination with a passing grade of 70% that includes questions the Board deems appropriate for the category of treatment modality for which the applicant provides evidence under R4-38-103 that are similar to those expected to be included in an examination in an approved postgraduate course in the treatment modality under R4-38-103;
2. An oral examination on one or more of the treatment modalities in R4-38-103 based on an actual clinical case history. The applicant shall present to the Board a summary of the clinical management of the sample case; and
3. A personal interview with the Board to examine the applicant's personal and professional history as it applies to homeopathic medicine. The Board may ask questions to clarify issues regarding the applicant's competence to engage in the practice of medicine safely, unprofessional conduct in the applicant's professional record, and whether the scope of the applicant's practice falls within the definition of homeopathic medicine.
B. An applicant who applies for licensure and provides evidence of postgraduate education under R4-38-103(C) may use a copy of Kent's Repertory or other repertory with clinically updated rubrics as a reference during the examination. An applicant shall not use a computer or other written material during the examination.
Historical Note
Adopted effective June 3, 1988 (Supp. 88-2). Section repealed; new Section made by final rulemaking at 11 A.A.R. 2008, effective July 2, 2005 (Supp. 05-2).
R4-38-107. Waiver of Written Examination
A. The following applies to an applicant requesting waiver under A.R.S. § 32-2913(A).
1. The Board shall not issue a license based on a waiver of the written examination without completion of an oral examination and a personal interview.
2. At the Board's discretion, an oral examination and personal interview may be conducted by a telephone conference call with a majority of the Board present.
B. Based on the application, oral examination, and personal interview, the Board shall determine whether the applicant qualifies for a waiver.
Historical Note
Adopted effective June 13, 1988 (Supp. 88-2). Amended effective February 7, 1995 (Supp. 95-1). Amended by final rulemaking at 11 A.A.R. 2008, effective July 2, 2005 (Supp. 05-2).
R4-38-108. Notification of Address Changes
A licensee shall advise the Board in writing within 45 days of opening an additional office address, a change in office address, change in home address, or change in telephone number.
Historical Note
Adopted effective June 13, 1988 (Supp. 88-2). Amended by final rulemaking at 11 A.A.R. 2008, effective July 2, 2005 (Supp. 05-2).
R4-38-109. Experimental Forms of Diagnosis and Treatment
A. The Board neither approves nor advocates specific experimental therapies. The Board considers the standards in this Section in determining whether a licensee is in compliance with A.R.S. § 32-2933(27). The Board considers a therapy that is in violation of applicable state or federal statutes, or state or federal rules or regulations regarding drugs and devices to be unprofessional conduct under A.R.S. § 32-2933(27).
B. Experimental forms of diagnosis or treatment, within the meaning of A.R.S. § 32-2933(27), include:
1. Administration of a pharmaceutical agent untested for safety in humans;
2. Use of a physical agent or electromagnetic current or field in a manner not supported by established clinical usage; and
3. Therapy modalities and diagnostic methods that are not included in the practice of homeopathic medicine as defined in A.R.S. § 32-2901(22) and do not meet the criteria of subsection (C).
C. The following are not an experimental form of diagnosis or treatment under A.R.S. § 32-2933(27):
1. A substance or therapy modality administered on a homeopathic indication that has been in beneficial clinical usage by professionally trained, legally qualified physicians for at least ten 10 years;
2. Homeopathic medications listed in the Homeopathic Pharmacopoeia of the United States;
3. Homeopathic medications that have been characterized by toxicity studies or by the "proving" method of administration on healthy volunteers to determine the medication's spectrum of action;
4. Administration of a pharmaceutical agent for a therapeutic indication supported by clinical usage if the agent is approved to be marketed publicly for other therapeutic indications by the appropriate regulatory agency; and
5. A procedure used for patient education, preventative medicine, or general health assessment or enhancement such as bio-terrain analysis, live blood analysis, soft laser, magnetic therapy, oxidative therapy, and microelectric therapy, and other procedures considered by the Board to be in beneficial clinical usage.
Historical Note
Adopted effective June 13, 1988 (Supp. 88-2). Amended by final rulemaking at 11 A.A.R. 2008, effective July 2, 2005 (Supp. 05-2).
R4-38-110. Repealed
Historical Note
Adopted effective June 3, 1988 (Supp. 88-2). Section repealed by final rulemaking at 11 A.A.R. 2008, effective July 2, 2005 (Supp. 05-2).
R4-38-111. Peer Review
A. A licensee using an experimental form of diagnosis and treatment such as vaccine therapy for cancer without affiliation with a recognized research institution, institutional review board, or peer review committee may request or the Board may require review of the procedure by the Board or a Board-appointed peer review committee.
B. In conducting the review, the Board or Board-appointed peer review committee shall examine protocols, recordkeeping, analyses of results, and informed patient consent forms and procedures. Based on the review, the Board shall determine the licensee's compliance with generally accepted homeopathic experimental criteria under A.R.S. § 32-2933(27).
C. As used in A.R.S. § 32-2933(27), "periodic review by a peer review committee" means peer review for compliance with any form of experimental medicine occurs at a minimum of five-year intervals through a recognized research institution, institutional review board, or a peer review committee. The chairperson of a Board-appointed peer review committee shall be appointed by the Board president and approved by the Board.
D. During a review of a licensee's use of experimental forms of diagnosis and treatment or at any other time the Board deems appropriate, the licensee shall submit informed patient consent forms and protocols and other records indicating the licensee's compliance with generally accepted experimental criteria designated in A.R.S. § 32-2933(27).
Historical Note
Adopted effective June 3, 1988 (Supp. 88-2). Amended by final rulemaking at 11 A.A.R. 2008, effective July 2, 2005 (Supp. 05-2).
R4-38-112. Registering Use of Experimental Forms of Diagnosis and Treatment
As part of an initial licensing application and subsequent annual renewal application, an applicant shall designate on a form provided by the Board the modalities of treatment used in the applicant's practice and forms of diagnosis and treatment used by the applicant that are defined as experimental by R4-38-109.
Historical Note
Adopted effective June 3, 1988 (Supp. 88-2). Amended by final rulemaking at 11 A.A.R. 2008, effective July 2, 2005 (Supp. 05-2).
R4-38-113. Chelation Therapy Practice Requirements
A. Before a licensee may practice chelation therapy for other than the treatment of metal poisoning, the licensee:
1. Shall document completion of the postgraduate education required in R4-38-103(C)(2); and
2. File a sample of the informed patient consent form and obtain approval of written disclosure from the Board as required by A.R.S. § 32-2933(27). As part of the documentation submitted with the informed patient consent form, the licensee shall include a copy of the therapy protocol.
B. If the Board approves the written disclosure under A.R.S. § 32-2933(27), the licensee may practice chelation therapy. The licensee shall ensure that detailed records and periodic analysis of results on patients consistent with the most recent informed consent and protocol on file with the Board are maintained consistent with A.R.S. § 32-2933(27) and available for periodic review by a peer review committee designated by the Board. Retention of patient medical and treatment records shall also conform with the requirements of A.R.S. § 12-2297.
Historical Note
Adopted effective June 3, 1988 (Supp. 88-2). Amended effective February 7, 1995 (Supp. 95-1). Amended by final rulemaking at 11 A.A.R. 2008, effective July 2, 2005 (Supp. 05-2).
R4-38-114. Rehearing or Review of Decision
A. Except as provided in subsection (G), any party to an appealable agency action or a contested case before the Board who is aggrieved by a decision rendered in the case may file with the Board not later than 30 days after service of the decision, a written motion for rehearing or review of the decision, specifying the particular grounds for the motion. A decision is served when personally delivered or five days after the date the decision is mailed to the party at the party's last known residence or place of business.
B. A motion for rehearing may be amended at any time before a ruling by the Board. Any other party may file a response within 15 days after the motion or amended motion is filed. The Board may require the filing of written briefs upon the issues raised in the motion and may provide for oral argument.
C. The Board may grant a rehearing or review of the decision for any of the following reasons materially affecting the moving party's rights:
1. Irregularity in the administrative proceedings of the Board or the hearing officer, or any order or abuse of discretion that results in the moving party being deprived of a fair hearing;
2. Misconduct of the Board or the non-moving party;
3. Accident or surprise that could not have been prevented by ordinary prudence;
4. Newly discovered material evidence that with reasonable diligence could not have been discovered and produced at the original hearing;
5. Excessive or insufficient penalties;
6. Error in the admission or rejection of evidence or other errors of law occurring at the administrative hearing; or
7. The decision is not justified by the evidence or is contrary to law.
D. The Board may affirm or modify the decision or grant a rehearing to all or any of the parties and on all or part of the issues for any of the reasons set forth in subsection (C). An order granting a rehearing shall specify the ground or grounds on which the rehearing is granted, and the rehearing shall cover only those matters.
E. Not later than 30 days after a decision is rendered, the Board may on its own initiative order a rehearing or review of its decision for any reason for which it might have granted a rehearing on motion of a party. After giving the parties or their counsel notice and an opportunity to be heard on the matter, the Board may grant a motion for rehearing for a reason not stated in the motion. In either case, the order granting the rehearing shall specify the grounds for the rehearing.
F. When a motion for rehearing is based upon an affidavit the party shall serve the affidavit with the motion. Within 10 days after service, an opposing party may serve an opposing affidavit. The Board may extend the period to serve an opposing affidavit for an additional 20 days for good cause shown or by written stipulation of the parties. The Board may permit a reply affidavit.
G. If the Board makes specific findings that the immediate effectiveness of the decision is necessary for the immediate preservation of the public peace, health, or safety and that a rehearing or review of the decision is impracticable, unnecessary, or contrary to the public interest, the Board may issue the decision as a final decision without an opportunity for a rehearing or review. If a decision is issued as a final decision without an opportunity for rehearing, any application for judicial review of the decision shall be made within the time limits permitted for applications for judicial review of the Board's final decisions.
H. The terms "contested case" and "party" as used in this Section are defined in A.R.S. § 41-1001. The term "appealable agency action" is defined in A.R.S. § 41-1092.
Historical Note
Adopted effective June 3, 1988 (Supp. 88-2). Amended by final rulemaking at 11 A.A.R. 2008, effective July 2, 2005 (Supp. 05-2).
R4-38-115. Use of Title and Abbreviation
A. The use of the abbreviation "M.D.(H.)" (with or without periods), is equivalent to the written designation, "Doctor of Medicine (Homeopathic)".
B. A Homeopathic physician practicing in this state who is not licensed by the Arizona Board of Medical Examiners or the Arizona Board of Osteopathic Examiners in Medicine and Surgery shall not use any designation other than the initials MD or DO to indicate a doctoral degree, which shall be followed by the full, written designation, "Homeopathic Physician."
C. A physician licensed by the Board and any state Board of Medical Examiners or the Board and any state Board of Osteopathic Examiners in Medicine and Surgery shall use one of the following designations, as appropriate (with or without periods):
1. "MD, MD(H)" or "DO, MD(H);"
2. "MD, Homeopathic Physician" or "DO, Homeopathic Physician;" or
3. "MD, Doctor of Medicine (Homeopathic)" or "DO, Doctor of Medicine (Homeopathic)."
D. A licensee practicing in this state shall display the license or an official duplicate license in a conspicuous location in the reception area of each office facility.
Historical Note
Adopted effective January 27, 1995 (Supp. 95-1). Amended by final rulemaking at 11 A.A.R. 2008, effective July 2, 2005 (Supp. 05-2).
ARTICLE 2. DISPENSING OF DRUGS BY
HOMEOPATHIC PHYSICIANS
R4-38-201. Definitions
In addition to the definitions in A.R.S. §§ 32-2901, 32-2933, and 32-2951, the following definitions apply in this Chapter:
1. "Administer" means the direct application of a controlled substance, prescription-only drug, dangerous drug as defined in A.R.S. § 13-3401, narcotic drug as defined in A.R.S. §13-3401, homeopathic medication, natural substance, or non-prescription drug, whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject by a homeopathic physician, a homeopathic physician's nurse or assistant, or by the patient or research subject at a homeopathic physician's direction.
2. "Label" means a display of written, printed, or graphic matter on the immediate container of an article and, on the outside wrapper or container, if the display on the immediate wrapper or container is not easily legible through the outside wrapper.
3. "Labeling" means all labels and other written, printed, or graphic matter:
a. On an article or any of its containers or wrappers and
b. Accompanying the article.
4. "Manufacturer" means each person who prepares, derives, produces, compounds, processes, packages or repackages, or labels a drug in a place devoted to manufacturing the drug, but does not include a pharmacy, pharmacist, or physician.
5. "Natural substance" means an herbal phytotherapeutic or oxygen, carbon, or nitrogen-based therapeutic agent, vitamin, mineral, or food-factor concentrate isolated from animal, vegetable, or mineral sources for nutritional augmentation.
6. "Official compendium" means the latest revisions of the Pharmacopoeia of the United States and the Homeopathic Pharmacopoeia of the United States, the latest revision of the National Formulary, or any current supplement.
7. "Packaging" means the act or process of placing a drug in a container to dispense or distribute the drug.
8. "Pharmaceutical drug" means a drug intended for use in preventing or curing disease or relieving pain.
Historical Note
Adopted effective September 13, 1993 (Supp. 93-3). Amended by final rulemaking at 9 A.A.R. 1599, effective July 5, 2003 (Supp. 03-2).
R4-38-202. General Provisions
A. A homeopathic physician shall not dispense unless the physician obtains from the Board a permit to dispense. The physician may renew the permit annually at the same time the license is renewed. The physician shall include the following on the permit application or renewal form:
1. The classes of drugs the physician will dispense, including controlled substances, pharmaceutical drugs, homeopathic medications, prescription-only drugs, natural substances, non-prescription drugs defined in A.R.S. § 32-1901(46), and devices defined in A.R.S. § 32-1901(18);
2. The location where the physician will dispense; and
3. A copy of the physician's current Drug Enforcement Administration (DEA) registration, or an affidavit averring that the physician does not possess a DEA registration and that the physician will not prescribe or dispense controlled substances.
B. If a homeopathic physician determines that a shortage exists in a controlled substance maintained for dispensing, the physician shall immediately notify the Board, the local law enforcement agency, and the Department of Public Safety by telephone. The physician shall also provide written notification to the Board within seven days of the date of the discovery of the shortage.
Historical Note
Adopted effective September 13, 1993 (Supp. 93-3). Amended by final rulemaking at 9 A.A.R. 1599, effective July 5, 2003 (Supp. 03-2).
R4-38-203. Repealed
Historical Note
Adopted effective September 13, 1993 (Supp. 93-3). Section repealed by final rulemaking at 9 A.A.R. 1599, effective July 5, 2003 (Supp. 03-2).
R4-38-204. Repealed
Historical Note
Adopted effective September 13, 1993 (Supp. 93-3). Section repealed by final rulemaking at 9 A.A.R. 1599, effective July 5, 2003 (Supp. 03-2).
R4-38-205. Repealed
Historical Note
Adopted effective September 13, 1993 (Supp. 93-3). Section repealed by final rulemaking at 9 A.A.R. 1599, effective July 5, 2003 (Supp. 03-2).
R4-38-206. Packaging
In addition to the requirements of A.R.S. § 32-2951, a dispensing homeopathic physician shall dispense a controlled substance or prescription-only pharmaceutical drug in a light-resistant container with a consumer safety cap, unless the patient or patient's representative and the physician agree otherwise.
Historical Note
Adopted effective September 13, 1993 (Supp. 93-3). Amended by final rulemaking at 9 A.A.R. 1599, effective July 5, 2003 (Supp. 03-2).
ARTICLE 3. EDUCATION, SUPERVISION, AND DELEGATION STANDARDS FOR REGISTRATION
OF MEDICAL ASSISTANTS BY HOMEOPATHIC PHYSICIANS
R4-38-301. Definitions
A. "Assists" means performing delegated procedures within the homeopathic physician's practice according to a written job description for which the Board has approved the assistant's educational program and the supervising physician's practice experience.
B. "Commensurate with the assistant's education and training" means that the assistant's education and training in either a formal or practical educational program meets Board standards for the specific technical functions in the job description for which the supervising physician makes application.
C. "Delegated procedures" refers to technical functions which are specifically outlined in the assistant's written job description and which may include any of the following:
1. Assisting in information-gathering functions, including history taking, measuring patients' vital signs, measuring patients' neuromuscular and electro-physiologic responses, specimen collection, and phlebotomy;
2. Assisting in information-processing functions including scoring of questionnaires, plotting of laboratory, physical, and chemical measurements, and symptom repertorization using standard homeopathic references or software programs;
3. Assisting in or administering patient treatments by physical; hygienic, including colonic irrigation; and electrical therapy modalities as ordered by the physician;
4. Assisting in delivery of drugs, devices, and natural substances to patients;
5. Assisting in patient health care education and counseling including nutritional and stress-management counseling;
6. Assisting in explaining and reinforcing home follow-up advice for physician-prescribed homeopathic therapy programs; and
7. Administration of skin tests and injections ordered by the physician.
D. "Educational program approved by the Board" means a formal educational program or a practical educational program which is recognized by the Board as sufficient to qualify a Medical Assistant to perform specific delegated procedures under the supervision of a physician.
E. "Formal educational program" means an organized course of study or training program in a technical field which includes didactic and supervised clinical experience and whose curriculums are approved by the Board.
F. "Physical medicine modalities" means hydrotherapy, including colonic irrigation; application of heat and cold; diathermy; electro-galvanic stimulation; ultrasound; traction; massage therapies; neuromuscular re-education procedures; application of transcutaneous nerve stimulator units; and the use of electronic micro-current devices for stimulation of nerve and muscle tissue.
G. "Practical educational program" means a course of study organized and directed by the supervising physician who conducts or verifies the didactic portion of the training and personally oversees or verifies the clinical experience portion of the training while the assistant is on the job.
H. "Under the supervision of" means that:
1. The supervising physician is physically on-site at the practice location during the day the delegated procedures are performed;
2. The supervising physician provides specific written orders for the medical Assistant for any treatment functions delegated to the medical assistant;
3. The medical assistant documents the performance of the delegated function in the office medical record by legible and identifiable notes;
4. An office, laboratory, or therapy note is prepared which is signed by the assistant and countersigned by the supervising physician within one week of the date of service for each visit in which a medical assistant performs delegated procedures;
5. The supervising physician has met Board-approved clinical experience standards as set forth in R4-38-303(B) or R4-38-305(B), for the procedure approved for delegation to the medical assistant;
6. All the delegated procedures and treatments could be legally performed by the supervising physician; and
7. The supervising physician ensures that there is regular discussion with each medical assistant with regard to individual patient's, responses to treatments or treatment programs delegated to that medical assistant.
Historical Note
Adopted effective January 27, 1995 (Supp. 95-1).
R4-38-302. Approved Formal Educational Programs
A. Physicians requesting that their assistants be approved for one or more of the following specified delegated procedures on the basis of a formal educational program shall submit evidence that the assistant has successfully completed the specified educational program:
1. General medical office procedures require completion of a course of instruction and training in a public or private school, college, or technical institute designed to place graduates in positions as General Office Medical Assistants. Such course of instruction shall consist of a minimum of the following:
a. 240 classroom hours in medical secretarial skills;
b. 240 classroom hours in back office assisting; and
c. 320 hours of supervised clinical experience.
2. Neuromuscular Integration therapy procedures:
a. Completion of a course of instruction and training in a public or private school, college, or technical institute designed to place graduates in positions as qualified Physical Therapy Assistants in a United States jurisdiction. Such course of instruction shall consist of a minimum of the following:
i. 1200 classroom hours in hands-on 22 techniques, sciences, theories and principles;
ii. 720 hours of supervised clinical experience; and
iii. 580 classroom hours in general studies; or
b. Completion of a professional program in massage therapy consisting of 1000 hours of didactic and clinical training or examination and certification sponsored by the American Massage Therapy Association; or
c. Completion of a professional training or certification program in Feldenkrais, Rolfing, Hellerwork, Trager, Orthobionomy, Shiatsu, Reiki, Polarity, Jin Shin Jyutsu, or similarly organized training program of at least 1000 hours of technical training and clinical supervision;
3. Acupuncture therapy procedures: completion of a didactic and clinical training program in acupuncture and examination and certification by the National Commission for the Certification of Acupuncturists (NCCA);
4. Homeopathic repertorization procedures: completion of at least 180 hours of a formal educational program as set forth in R4-38-301(E) or preceptorship in a homeotherapeutics program approved by the Board including those certified by the Council for Homeopathic Certification; or
5. Nutritional counseling procedures require completion of one of the following:
a. Board-approved formal educational program in clinical nutrition consisting of 500 hours or more of training; or
b. Certification by the International University for Nutrition Education.
B. Physicians proposing job descriptions for assistants in general medical or homeopathic practices and procedures not herein specified shall submit evidence that is satisfactory to the Board that the assistant has completed a degree of educational training and clinical supervision that is substantially equivalent to the formal educational requirements in the above areas.
Historical Note
Adopted effective January 27, 1995 (Supp. 95-1).
R4-38-303. Supervision of Formally Trained Assistants
A. In order for a homeopathic physician to delegate specified homeopathic diagnostic and therapeutic procedures, as described in this rule, his or her qualifications shall be approved by the Board.
B. Approval may be granted by the Board after its review of the physicians' educational and practice experience in the specified delegated procedure. Such experience may include the completion of 25 hours of homeopathic post-graduate education in the specified delegated procedure. Certificates of attendance and completion of such courses shall be submitted with the application form supplied by the Board.
C. Physicians may submit documentation of practice experience substantially equivalent to post-graduate training in the specified Homeopathic modalities for individual approval by the Board.
D. Supervision of the medical assistants performing general medical office procedures recognized as common within the allopathic and osteopathic community does not require any additional experience and training beyond that contained in the requirements for licensure as a homeopathic physician.
Historical Note
Adopted effective January 27, 1995 (Supp. 95-1).
R4-38-304. Approved Practical Educational Programs
A. Unlicensed persons who have not completed a Board-approved formal educational program in delegated office procedures may receive on-the-job training and clinical supervision in a practical educational program conducted by the supervising homeopathic physician.
B. A homeopathic physician shall apply for and obtain approval from the Board in order to conduct a practical educational program. Separate written Board approval shall be obtained for each medical assistant that participates in the practical educational program.
C. Request for approval for a practical training program shall be submitted on a form supplied by the Board and shall contain:
1. A written training protocol for the procedure or procedures in question;
2. A detailed description of the physician's background and expertise in the procedure or procedures being taught;
3. A proposed job description which specifies how the assistant will eventually perform those procedures delegated by the supervising physician and within the supervising physician's practice; and
4. Documentation of any previous on-the-job or formal training of the assistant.
D. Training protocols submitted for approval shall meet the following standards for the specified job descriptions:
1. General medical job descriptions: completion of 400 hours of didactic instruction and clinical supervision;
2. Job descriptions delegating acupuncture treatments for medical and pain management applications: completion of the academic portion of a course of study offered by a member institution of the National Association of Colleges of Acupuncture and Oriental Medicine, a World Health Organization-designated training facility for acupuncture, or an equivalent approved by the Board, plus a minimum of 500 hours of clinical supervision by a qualified supervising physician;
3. Job descriptions delegating acupuncture treatments for drug detoxification purposes: completion of a course of training in acupuncture drug detoxification consisting of a minimum of 70 hours in both diagnostic and supervised apprenticeship conducted by the National Acupuncture Detoxification Association (NADA) and approved by the Board, plus clinical supervision of a least 160 hours by a qualified supervising physician;
4. Job descriptions delegating information gathering using electro-diagnostic procedures and devices: completion of a didactic course of study of at least 35 hours in electro-diagnostic methodology, plus at least 160 hours of clinical supervision by a qualified supervising physician;
5. Job descriptions delegating physical medicine treatment modalities require completion of one of the following:
a. Technical massage course of at least 50 hours of study and certification by any Arizona jurisdiction; or
b. On-the-job training of at least 50 hours in a specified physical medicine modality including didactic instruction and clinical supervision; or
6. Job descriptions delegating homeopathic repertorization procedures: completion of at least 180 hours in homeotherapeutics including at least 40 hours of didactic instruction and at least 40 hours of clinical supervision.
Historical Note
Adopted effective January 27, 1995 (Supp. 95-1).
R4-38-305. Supervision of Practical Educational Programs
A. The Board shall review and approve the qualifications of a physician seeking to conduct a practical educational program.
B. A physician shall document on the request for approval his or her background in formal training and his or her experience in the particular procedure in which the medical assistant will be trained. The following levels of training are required for a physician to conduct a training program in the specified delegated procedures:
1. General medical assistant training program: two years of active practice following completion of M.D. or D.O. post-graduate education;
2. General Acupuncture therapeutics practical educational program: 220 hours of post-graduate training in medical acupuncture and two years of clinical experience in acupuncture therapeutics;
3. Practical educational program in Acupuncture Detoxification procedures:
a. A fellowship or certification in addiction medicine plus 25 hours of post-graduate education, approved by the Board, in acupuncture therapy for drug detoxification; or
b. Two years of documented, Board-approved experience in conducting clinical addiction treatments or therapy plus 25 hours of post-graduate education, approved by the Board, in acupuncture therapy for drug detoxification;
4. Practical educational program for an assistant performing electro-diagnostic procedures: completion of at least 80 hours of formal training in electro-diagnosis and two years of clinical experience in electro-diagnostic methodology.
5. Practical educational program in specified aspects of neuromuscular integration therapies or physical medicine modalities:
a. Completion of a residency or fellowship in physical medicine;
b. At least 220 hours of post-graduate training in neuromuscular integration therapies; or
c. Two years of clinical experience in medical orthopedics, physical medicine modalities, osteopathic manipulative medicine, chiropractic manual therapy, or an equivalent neuromuscular integration therapy, such as those listed in R4-38-302,(A)(2)(c); or
6. Practical educational program in homeopathic repertorization:
a. Five years of clinical practice and 200 hours of continuing medical education in classical homeotherapeutics; or
b. Diplomate status granted by the American Board of Homeotherapeutics or by the British Institute of Homeopathy.
Historical Note
Adopted effective January 27, 1995 (Supp. 95-1).
R4-38-306. Restrictions on Delegated Procedures
A physician may not delegate the following procedures to an unlicensed person:
1. Psycho-therapeutic procedures, including individual and group psychotherapy, clinical hypnosis, or other behavioral health interventions subject to independent regulation in Arizona;
2. The dispensing of drugs, homeopathic agents, herbal products, natural products, and therapy devices when the supervising physician has not registered with the Board to include dispensing privileges as part of the supervising physician's practice.
Historical Note
Adopted effective January 27, 1995 (Supp. 95-1).
R4-38-307. Unprofessional Conduct
The following conduct in regard to the delegating of procedures to medical assistants is conduct or practice which does or might constitute a danger to the health, welfare, or safety of the patient or the public:
1. Failure of the physician to perform and document in the medical record the following for each patient on whom delegated procedures are performed:
a. Initial evaluation;
b. Treatment-planning;
c. Periodic re-evaluation of the patient's health status; and
d. Termination or modification of the patient's treatment program at the conclusion of the prescribed course of therapy;
2. Obtaining board approval for training and/or supervision of Medical Assistants under false pretenses;
3. Failure to adhere to the supervision criteria outlined in R4-38-301(H)(1-7), and R4-38-309;
4. Failure to register or re-register medical assistants as required by these rules;
5. Allowing assistants to perform procedures not specified in their Board-approved job description; or
6. Failure to obtain approval by the Board to conduct a practical educational program to supervise an unlicensed person who has not yet completed a Board-approved medical assistant medical educational program.
Historical Note
Adopted effective January 27, 1995 (Supp. 95-1).
R4-38-308. Registration Procedures for Medical Assistants and Practical Educational Programs
A. The supervising physician shall register each medical assistant with the Board within two weeks of employment by submitting an application on a form supplied by the Board which documents the following:
1. The medical assistant's proposed job description;
2. The medical assistant's educational qualifications for the proposed delegated procedures;
3. A complete curriculum vitae of the medical assistant; and;
4. The supervising physician's qualifications to supervise the proposed delegated procedures.
B. The application shall be accompanied by certificates of participation in training; proficiency certifications by relevant Boards, associations, or societies; individual letters of documentation of preceptorships; or letters confirming on-the-job training by the parties who supervised such training.
C. Job descriptions or functions other than generally recognized homeopathic office procedures specified in these rules will be subject to individual review and approval by the full Board.
D. Upon approval of the application by the Board, the medical assistant shall perform his or her duties while wearing a clearly labeled name tag stating the designation, "medical assistant", and the specific modality or class of expertise.
E. A medical assistant's registration shall be valid until the end of the calendar year in which the application was approved. This registration shall be deemed valid by the Board for an additional two years as long as the supervising physician remits annual payment of the renewal fee concurrent with his or her own annual physician's license renewal. A registration shall expire either:
1. Upon termination of the medical assistant's employment by the supervising physician;
2. Upon nonpayment by the supervising physician of the renewal extension fees by their due dates; or
3. On December 31st of the second year subsequent to the year that the registration was initially approved.
F. Once a medical assistant's registration has expired, the employing supervising physician shall submit a complete and updated registration application and initial registration fee for re-approval by the Board.
G. Each physician proposing to conduct an on-the-job or practical educational program for medical assistants shall apply for such approval within two weeks of employment of the medical assistant by submitting an application on a form supplied by the Board. This form is in addition to the medical assistant registration form.
H. Each physician who continues to actively train medical assistants shall renew the practical education training program registration annually by submitting an updated application for each of his or her current training protocols.
Historical Note
Adopted effective January 27, 1995 (Supp. 95-1).
R4-38-309. Multiple Supervisors
A. A medical assistant employed by more than one homeopathic physician shall have his or her job description registered with the Board for each place of employment.
B. Registration and job description approval are not transferable upon change in employment, and a new application shall be made by the new employer upon hiring a new medical assistant.
C. An employing physician may, at the time of initial registration, or as an addendum to a current registration, add to the medical assistant's job description the name and qualifications of one or more alternative supervising physicians within the employing physician's medical group, or who provides on-site coverage for the supervising physician during periods of absence who will insure proper supervision and documentation of the performance of the delegated procedures by the medical assistant.
Historical Note
Adopted effective January 27, 1995 (Supp. 95-1).
R4-38-310. Previously Licensed Practitioners
A. Medical assistant status with supervision by an Arizona- licensed homeopathic physician is not intended to allow a health care practitioner who would otherwise be subject to regulation by licensure in Arizona to practice his or her profession outside of that profession's formal regulatory authority.
B. Homeopathic physicians proposing to employ as a medical assistant a person previously licensed or subject to professional regulation as a health care professional in a U.S. jurisdiction shall document and submit for approval to the Board on forms supplied by the Board the following information:
1. A complete curriculum vitae of the applicant in question; and
2. An affidavit from the applicant, stating the reasons for which the applicant seeks employment as a homeopathic medical assistant rather than as a licensed Arizona health care provider in accordance with his or her professional training.
C. The Board shall conduct a background check of the applicant's previous health professional practice in all jurisdictions previously licensed, sufficient to determine if the applicant has or had engaged in unprofessional conduct, or is or was deemed incompetent, or was physically or mentally unable to safely engage in the rendering of health care services.
D. The Board shall conduct a personal interview with the supervising physician and the proposed assistant to determine the accuracy of the proposed job description, that the relationship will not constitute a violation of A.R.S. § 32-2933(11), and an understanding by the physician of his or her supervisory responsibilities and by the proposed assistant of his or her limitations under these rules and applicable statutes.
Historical Note
Adopted effective January 27, 1995 (Supp. 95-1).
R4-38-311. Deadlines for Compliance with Rules
A. Physicians employing medical assistants as of the effective date of this rule shall complete the initial registration within six months, or as of the annual renewal date for the supervising physician's license, whichever comes first.
B. Any person employed as a medical assistant as of the effective date of this rule shall complete all training required by his or her job description category within 12 months of the effective date of this rule. His or her supervising physician shall document the medical assistant's completion of this training.
C. Within three months of the effective date of this rule, all physicians conducting on-the-job training as part of a practical educational program shall submit the necessary documentation in order to receive Board approval to conduct practical educational training in the various procedures included in their assistant's job descriptions.
D. Following initial registration, renewals will be due concurrent with the next and each subsequent renewal of the homeopathic physician's license.
Historical Note
Adopted effective January 27, 1995 (Supp. 95-1).
ARTICLE 4. APPLICATION AND RENEWAL PROCESS; TIME-FRAMES
R4-38-401. Definitions
In this Article, the following terms apply:
1. "Application period" means 365 days, starting from the date an initial application and fee are received in the Board office under A.R.S. § 32-2912(F)(3) and (4).
2. "Deficiency notice" means a written, comprehensive list of missing information or documents.
3. "Prescribed fee" means a fee permitted by A.R.S. § 32-2914 or prescribed by R4-38-104.
4. "Serve" means sending the document by U.S. mail to the last address provided by the applicant.
5. "Staff" means any person employed or designated by the Board to perform administrative tasks.
Historical Note
Adopted effective September 24, 1998 (Supp. 98-3).
R4-38-402. Application; Initial License, Permit, or Registration
A. An applicant shall submit to the Board office a signed, notarized application form, the contents of which are described by A.R.S. Title 32, Chapter 29 and 4 A.A.C. 38; any supporting information required; and the prescribed fee. Within 90 days after receipt of an initial application package, staff shall finish an administrative completeness review.
1. If the application package is complete, staff shall serve the applicant with a written notice of administrative completeness informing the applicant of the date, time, and place of the Board's consideration of the application.
2. If the application package is deficient, staff shall serve the applicant with a written deficiency notice. The 90-day time-frame for staff to finish the administrative completeness review is suspended from the date the deficiency notice is served until all missing information is received.
B. Except as otherwise provided by law, the applicant shall provide all missing information within 180 days after the date on the deficiency notice, including information from other agencies, institutions, and persons. If the applicant has not already done so, the applicant shall take the written examination prescribed in R4-38-105 within the 180 days.
C. Within 90 days after receipt of a complete initial application package, the Board shall render a decision on the initial license, permit, or registration. The applicant shall undergo the oral examination and interview prescribed in R4-38-106 within the 90 days.
1. If the Board finds the applicant meets the licensing requirements, the Board shall grant a license effective on the date that the Board receives the license issuance fee. If no license fee is required, the Board shall grant the permit or registration, which is effective on the date granted.
2. If the Board finds the applicant does not meet the licensing requirements, the Board shall issue a written notice of denial of license.
3. If the Board determines that there are substantive deficiencies in the application, the Board shall serve a single comprehensive written request for additional information.
4. The 90-day substantive review time-frame is suspended from the date on the request for additional information until the date that all requested information is received. Except as otherwise provided by law, the applicant shall provide the requested information within 60 days from the date on the notice.
D. If an applicant fails to provide the information required in subsections (B) and (C), the Board shall determine whether to deny the application or to consider it withdrawn under A.R.S. § 32-2912(F).
Historical Note
Adopted effective September 24, 1998 (Supp. 98-3).
R4-38-403. Application; Renewal of License, Permit, or Registration
A. On or before the deadlines prescribed in A.R.S. § 32-2915(D), an applicant for renewal of a license, permit or registration shall submit to the Board a renewal application form, the contents of which are prescribed by A.R.S. Title 32, Chapter 29 and 4 A.A.C. 38, and the appropriate fees.
B. Within 30 days after receipt of a renewal application package, staff shall notify the applicant that the package is either complete or deficient.
1. If the application package is complete, staff may serve the applicant with a written notice of administrative completeness. If the notice of administrative completeness is not served within 30 days after receipt of a renewal application package, the package is deemed complete.
2. If the renewal application package is deficient, staff shall serve the applicant with a written deficiency notice. The 30-day time-frame for staff to finish the administrative completeness review is suspended from the date the deficiency notice is served until all missing information is received.
C. Except as otherwise provided by law, an applicant for renewal shall provide all missing information within 10 days after the date on the deficiency notice or by the applicable deadline prescribed in A.R.S. § 32-2915, whichever is later.
D. Within 90 days of receipt of a complete renewal application package, the Board shall either issue a license renewed notice, showing the effective year of renewal, or conduct a substantive review of those renewal applications which, when considered alone or in conjunction with additional information, raise a concern that the applicant's conduct may be in violation of A.R.S. Title 32, Chapter 29. The Board shall investigate and resolve such a concern under A.R.S. § 32-2934.
E. If an applicant for renewal fails to provide the missing information required by subsection (C), the license, permit, or registration expires effective January 1 of the renewal year for which the application was made and the Board shall not refund any renewal fees paid for that year.
Historical Note
Adopted effective September 24, 1998 (Supp. 98-3).