Second Regular Session H.B. 2549
PROPOSED
SENATE AMENDMENTS TO H.B. 2549
(Reference to House engrossed bill)
Page 1, between lines 1 and 2, insert:
"Section 1. Section 32-1501, Arizona Revised Statutes, is amended to read:
32-1501. Definitions
In this chapter, unless the context otherwise requires:
1. "Accepted therapeutic purpose" means treatment of a disease, injury, ailment or infirmity that is competent and generally recognized as safe and effective.
2. "Active license" means a current valid license to practice naturopathic medicine.
3. "Adequate medical records" means legible medical records containing, at a minimum, sufficient information to identify the patient, support the diagnosis, describe the treatment, accurately document the results, indicate advice and cautionary warning provided to the patient and provide sufficient information for a similarly qualified practitioner to assume continuity of the patient's care at any point in the course of treatment.
4. "Approved clinical training program" or "clinical training program" means a program for naturopathic medical students in which the training occurred or is being conducted by or in conjunction with an approved school of naturopathic medicine.
5. "Approved internship program" or "internship" means that the program in which the training occurred or is being conducted has been approved for internship training for physicians or for graduates of a school of naturopathic medicine by the board or was approved or accredited by an educational or professional association recognized by the board or by another state's or country's licensing agency recognized by the board.
6. "Approved postdoctoral training" or "postdoctoral training" means that the program in which the training occurred or is being conducted has been approved for specialty training or for graduate medical education in naturopathic medicine by the board or approved or accredited by an educational or professional association recognized by the board or by another state's or country's licensing agency recognized by the board.
7. "Approved preceptorship program" or "preceptorship" means that the program in which the training occurred or is being conducted has been approved for preceptorship training for physicians or for graduates of a school of naturopathic medicine by the board or was approved or accredited by an educational or professional association recognized by the board or by another state's or country's licensing agency recognized by the board.
8. "Approved school of naturopathic medicine" or "school of naturopathic medicine" means a school or college determined by the board to have an educational program that meets standards prescribed by the council on naturopathic medical education, or its successor agency, and that offers a course of study that, on successful completion, results in the awarding of the degree of doctor of naturopathic medicine and whose course of study is either of the following:
(a) Accredited or a candidate for accreditation by an accrediting agency recognized by the United States secretary of education as a specialized accrediting agency for schools of naturopathic medicine or its successor.
(b) Accredited or a candidate for accreditation by an accrediting agency recognized by the council for higher education accreditation or its successor.
9. "Board" means the naturopathic physicians medical board.
10. "Chelation therapy" means an experimental medical therapy to restore cellular homeostasis through the use of intravenous, metal‑binding and bioinorganic agents such as ethylene diamine tetraacetic acid. Chelation therapy does not include experimental therapy used to treat heavy metal poisoning.
11. "Completed application" means that the applicant paid the required fees and supplied all documents and information as requested by the board and in a manner acceptable to the board.
12. "Controlled substance" means a drug, substance or immediate precursor in schedules I through V of title 36, chapter 27, article 2.
13. "Direct supervision" means that a physician who is licensed pursuant to this chapter or chapter 13, 17 or 29 of this title:
(a) Is physically present and within sight or sound of the person supervised and is available for consultation regarding procedures that the physician has authorized and for which the physician remains responsible.
(b) Has designated a person licensed pursuant to this chapter or chapter 13, 17 or 29 of this title to provide direct supervision in the physician's absence.
14. "Doctor of naturopathic medicine" or "doctor" means a natural person who is licensed to practice naturopathic medicine under this chapter.
15. "Drug" has the same meaning prescribed in section 32‑1901 but does not include:
(a) Intravenous administration of legend drugs, except for:
(i) Vitamins, chelation therapy and drugs used in emergency resuscitation and stabilization.
(ii) Minerals.
(iii) Nutrients. For the purposes of this item, "nutrient" means a substance that provides nourishment for growth or metabolism and that is manufactured and supplied for intravenous use by a manufacturer registered with the United States food and drug administration or compounded by a pharmacy licensed by the Arizona state board of pharmacy.
(b) Controlled substances listed as schedule I or II controlled substances as defined in the federal controlled substances act of 1970 (21 United States Code section 802), except morphine, any drug that is reclassified from schedule III to schedule II after January 1, 2014 and any homeopathic preparations that are also controlled substances.
(c) Cancer chemotherapeutics classified as legend drugs.
(d) Antipsychotics.
16. "General supervision" means that the physician is available for consultation regarding procedures that the physician has authorized and for which the physician remains responsible.
17. "Legend drug" means any drug that is defined by section 503(b) of the federal food, drug, and cosmetic act and under which definition its label is required to bear the statement "Rx only".
18. "Letter of concern" means a nondisciplinary advisory letter that is issued by the board to a person who is regulated under this chapter and that states that while there is insufficient evidence to support disciplinary action the board believes that the person should modify or eliminate certain practices and that continuation of the activities that led to the information being submitted to the board may result in action against the person's license, certificate or registration.
19. "Letter of reprimand" means a disciplinary letter that is issued by the board and that informs a person who is regulated under this chapter that the person's conduct violates state or federal law but does not require the board to restrict the person's license, certificate or registration because the person's conduct did not result in harm to a patient or to the public.
20. "Limit" means taking a nondisciplinary action that alters the physician's practice or professional activities if the board determines that there is evidence that the physician is or may be mentally or physically unable to safely engage in the practice of medicine.
21. "Medical assistant" or "naturopathic medical assistant" means a person who is certified by the board as a medical assistant, who assists a doctor of naturopathic medicine and who may perform delegated procedures that are commensurate with the assistant's education and training under the direct supervision of a doctor of naturopathic medicine and that do not include diagnosing, designing or modifying established treatment programs or those procedures prohibited by the board or by this chapter.
22. "Medically incompetent" means a person who is licensed, certified or registered pursuant to this chapter and who lacks sufficient naturopathic medical knowledge or skills, or both, to a degree that is likely to endanger the health of patients.
23. "Natural substance" means a homeopathic, botanical, nutritional or other supplement that does not require a prescription pursuant to federal law before it is prescribed, dispensed or otherwise furnished to a patient and that is prescribed by a physician who is licensed pursuant to this chapter to enhance health, prevent disease or treat a medical condition diagnosed by the physician.
24. "Naturopathic medical student" means a person who is enrolled in a course of study at an approved school of naturopathic medicine.
25. "Naturopathic medicine" means medicine as taught in approved schools of naturopathic medicine and in clinical, internship, preceptorship and postdoctoral training programs approved by the board and practiced by a recipient of a degree of doctor of naturopathic medicine licensed pursuant to this chapter.
26. "Nurse" means a person who is licensed pursuant to chapter 15 of this title.
27. "Physician" means a doctor of naturopathic medicine who is licensed pursuant to this chapter.
28. "Practice of naturopathic medicine" means a medical system of diagnosing and treating diseases, injuries, ailments, infirmities and other conditions of the human mind and body, including by natural means, drugless methods, drugs, nonsurgical methods, devices, physical, electrical, hygienic and sanitary measures and all forms of physical agents and modalities.
29. "Restrict" means taking a disciplinary action that alters the physician's practice or professional activities if the board determines that there is evidence that the physician is or may be medically incompetent or guilty of unprofessional conduct.
30. "Specialist" means a physician who has successfully completed approved postdoctoral training, who is certified by a specialty board of examiners recognized by the board and who is certified by the board to practice the specialty pursuant to this chapter.
31. "Unprofessional conduct" includes the following, whether occurring in this state or elsewhere:
(a) Intentionally disclosing a professional secret or intentionally disclosing a privileged communication except as either of these may otherwise be required by law.
(b) Engaging in any dishonorable conduct reflecting unfavorably on the profession.
(c) Committing a felony, whether or not involving moral turpitude, or a misdemeanor involving moral turpitude. In either case conviction by any court of competent jurisdiction or a plea of no contest is conclusive evidence of the commission of the felony or misdemeanor.
(d) Habitual intemperance in the use of alcohol or any substance abuse.
(e) Engaging in the illegal use of any narcotic or hypnotic drugs, or illegal substances.
(f) Engaging in conduct that the board determines is gross malpractice, repeated malpractice or any malpractice resulting in the death of a patient.
(g) Impersonating another doctor of naturopathic medicine or any other practitioner of the healing arts.
(h) Falsely acting or assuming to act as a member, an employee or an authorized agent of the board.
(i) Procuring or attempting to procure a license or a certificate pursuant to this chapter by fraud, by misrepresentation or by knowingly taking advantage of the mistake of another person or agency.
(j) Having professional connection with or lending one's name to enhance or continue the activities of an illegal physician or an illegal practitioner of any healing art.
(k) Representing that a manifestly incurable disease, injury, ailment or infirmity can be permanently cured, or falsely or fraudulently representing that a curable disease, injury, ailment or infirmity can be cured within a stated time.
(l) Offering, undertaking or agreeing to cure or treat a disease, injury, ailment or infirmity by a secret means, method, treatment, medicine, substance, device or instrumentality.
(m) Refusing to divulge to the board on demand the means, method, treatment, medicine, substance, device or instrumentality used in the treatment of a disease, injury, ailment or infirmity.
(n) Giving or receiving, or aiding or abetting the giving or receiving of, rebates, either directly or indirectly.
(o) Knowingly making any false or fraudulent statement, written or oral, in connection with the practice of naturopathic medicine or any naturopathic treatment method.
(p) Engaging in immorality or misconduct that tends to discredit the naturopathic profession.
(q) Refusal, revocation or suspension of Having a license refused, revoked or suspended by any other state, district or territory of the United States or any other country, unless it can be shown that this action was not due to reasons that relate to the ability to safely and skillfully practice as a doctor of naturopathic medicine or to any act of unprofessional conduct in this paragraph.
(r) Engaging in any conduct or practice that is contrary to recognized standards of ethics of the naturopathic profession, any conduct or practice that does or might constitute a danger to the health, welfare or safety of the patient or the public, or any conduct, practice or condition that does or might impair the ability to safely and skillfully practice as a doctor of naturopathic medicine.
(s) Failure Failing to observe any federal, state, county or municipal law relating to public health as a physician in this state.
(t) Violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate this chapter or board rules.
(u) Committing false, fraudulent, deceptive or misleading advertising or advertising the quality of a medical or health care service by a physician or by the physician's staff, employer or representative.
(v) Failing or refusing to maintain adequate medical records on a patient or failing or refusing to make medical records in the physician's possession promptly available to another physician or health care provider who is licensed pursuant to chapter 7, 8, 13, 15, 17 or 29 of this title on request and receipt of proper authorization to do so from the patient, a minor patient's parent, the patient's legal guardian or the patient's authorized representative or failing to comply with title 12, chapter 13, article 7.1.
(w) Referring a patient to a diagnostic or treatment facility or prescribing goods and services without disclosing in writing to the patient that the physician has a pecuniary interest in the facility, goods or services to which the patient is referred or prescribed. This subdivision does not apply to a referral by one physician or practitioner to another physician or practitioner within a group of physicians or practitioners practicing together.
(x) Engaging in sexual intimacies with a patient in the course of direct treatment.
(y) Failing to dispense drugs and devices in compliance with article 4 of this chapter.
(z) Administering, dispensing or prescribing any drug or a device for other than an accepted therapeutic purpose.
(aa) Falsely representing or holding oneself out as being a specialist or representation by a doctor of naturopathic medicine or the doctor's staff, employer or representative that the doctor is boarded or board certified if this is not true or that standing is not current.
(bb) Delegating professional duties and responsibilities to a person if the person has not been approved or qualified by licensure or by certification to perform these duties or responsibilities.
(cc) Failing to appropriately supervise a naturopathic medical student, a nurse, a medical assistant, a health care provider or a technician who is employed by or assigned to the physician during the performance of delegated professional duties and responsibilities.
(dd) Using experimental forms of diagnosis or treatment without adequate informed consent of the patient or the patient's legal guardian and without conforming to experimental criteria, including protocols, detailed records, periodic analysis of results and periodic review by a medical peer review committee as approved by the federal United states food and drug administration or its successor agency.
(ee) Failing to furnish information in a timely manner to the board or investigators or representatives of the board if this information is legally requested by the board and failing to allow properly authorized board personnel on demand to examine and have access to documents, reports and records maintained by the physician that relate to the physician's medical practice or medically related activities.
(ff) Failing to report in writing to the board evidence that a person who is licensed, certified or registered pursuant to this chapter is or may be medically incompetent, guilty of unprofessional conduct or mentally or physically unable to safely practice or assist in the practice of naturopathic medicine.
(gg) Conducting or engaging in an internship, preceptorship or clinical training program in naturopathic medicine without being approved and registered by the board for that internship, preceptorship or clinical training program.
(hh) Signing a blank, undated or predated prescription form.
(ii) Engaging in conduct that the board determines is gross negligence, repeated negligence or negligence resulting in harm or death to a patient.
(jj) Knowingly making a false or misleading statement in oral testimony to the board on a form required by the board or in written correspondence to the board, including attachments to that correspondence.
(kk) The failure of a physician who is the chief medical officer, the executive officer or the chief of staff of an internship, a preceptorship or a clinical training program to report in writing to the board that the privileges of a doctor of naturopathic medicine, a naturopathic medical student or a medical assistant have been denied, limited, revoked or suspended because that doctor's, student's or assistant's actions appear to indicate that the person is or may be medically incompetent, is or may be guilty of unprofessional conduct or is or may be unable to safely engage or assist in the practice of naturopathic medicine.
(ll) having action taken against a doctor of naturopathic medicine by a licensing or regulatory board in another jurisdiction due to that doctor's mental or physical inability to engage safely in the practice of naturopathic medicine or the doctor's medical incompetence or for unprofessional conduct as defined by that licensing or regulatory board and that corresponds directly or indirectly to an act of unprofessional conduct prescribed by this paragraph. The action taken may include refusing, denying, revoking or suspending a license, otherwise limiting, restricting or monitoring a licensee or placing a licensee on probation by that licensing or regulatory board.
(mm) Having sanctions imposed by an agency of the federal government, including restricting, suspending, limiting or removing a person from the practice of naturopathic medicine or restricting that person's ability to obtain financial remuneration.
(nn) Violating any formal order, probation, consent agreement or stipulation issued or entered into by the board pursuant to this chapter.
(oo) Refusing to submit to a body fluid examination pursuant to a board investigation of alleged substance abuse by a doctor of naturopathic medicine.
(pp) Charging a fee for services not rendered or dividing a professional fee for patient referrals among health care providers or health care institutions or between these providers and institutions or a contractual arrangement that has this effect.
(qq) Obtaining a fee by fraud, deceit or misrepresentation.
(rr) Charging or collecting a clearly excessive fee. In determining if whether a fee is clearly excessive, the board shall consider the fee or range of fees customarily charged in this state for similar services, in light of modifying factors such as the time required, the complexity of the service and the skill required to perform the service properly. This subdivision does not apply if there is a clear written contract for a fixed fee between the physician and the patient that was entered into before the service was provided.
(ss) With the exception of heavy metal poisoning, using chelation therapy in the treatment of arteriosclerosis or as any other form of therapy without adequate informed patient consent and without conforming to generally accepted experimental criteria, including protocols, detailed records, periodic analysis of results and periodic review by a medical peer review committee.
(tt) Using a controlled substance unless it is prescribed by another physician for use during a prescribed course of treatment.
(uu) Prescribing, dispensing or administering anabolic androgenic steroids for other than therapeutic purposes.
(vv) Except in an emergency or urgent care situation, prescribing or dispensing a controlled substance to a member of the naturopathic physician's immediate family.
(ww) Prescribing, dispensing or furnishing a prescription medication or a prescription‑only device as defined in section 32‑1901 to a person unless the licensee first conducts a physical examination of that person or has previously established a doctor‑patient relationship. The physical examination may be conducted during a real‑time telemedicine encounter with audio and video capability unless the examination is for the purpose of obtaining a written certification from the physician for the purposes of title 36, chapter 28.1. This subdivision does not apply to:
(i) A licensee who provides temporary patient supervision on behalf of the patient's regular treating licensed health care professional.
(ii) An emergency medical situation as defined in section 41‑1831.
(iii) Prescriptions written to prepare a patient for a medical examination.
(iv) Prescriptions written or prescription medications issued for use by a county or tribal public health department for immunization programs or emergency treatment or in response to an infectious disease investigation, a public health emergency, an infectious disease outbreak or an act of bioterrorism. For the purposes of this item, "bioterrorism" has the same meaning prescribed in section 36‑781.
(v) Prescriptions written or antimicrobials dispensed to a contact as defined in section 36‑661 who is believed to have had significant exposure risk as defined in section 36‑661 with another person who has been diagnosed with a communicable disease as defined in section 36‑661 by the prescribing or dispensing physician.
(vi) Prescriptions written by a licensee through a telemedicine program that is covered by the policies and procedures adopted by the administrator of a hospital or outpatient treatment center.
(xx) If medical treatment is considered experimental or investigational, failing to include in a patient's record a consent to treatment document that is signed by the patient or the patient's parent or legal guardian and that indicates that the patient or the patient's parent or legal guardian has been informed of the risk of any treatment to be provided and the expected cost of that treatment.
(yy) When issuing a written certification as defined in section 36‑2801, failing or refusing to include in the adequate medical records of a patient a copy of all of the following:
(i) The medical records relied on by the physician to support the diagnosis or confirmed diagnosis of the patient's debilitating medical condition.
(ii) The written certification.
(iii) The patient's profile on the Arizona board of pharmacy controlled substances prescription monitoring program database.
(zz) Dispensing a schedule Ii controlled substance that is an opioid.
Sec. 2. Section 32-1581, Arizona Revised Statutes, is amended to read:
32-1581. Dispensing of natural substances, drugs and devices; conditions; civil penalty; dispensing minerals; rules; definitions
A. A doctor of naturopathic medicine may dispense a natural substance, a drug, except a schedule II controlled substance that is an opioid, or a device to a patient for a condition that is being diagnosed or treated by the doctor if:
1. The doctor is certified to dispense by the board and the certificate has not been suspended or revoked by the board.
2. The natural substance, drug or device is dispensed and properly labeled with the following dispenser information:
(a) The dispensing doctor's name, address and telephone number and a prescription number or other method of identifying the prescription.
(b) The date the natural substance, drug or device is dispensed.
(c) The patient's name.
(d) The name and strength of the natural substance, drug or device, directions for proper and appropriate use and any cautionary statements for the natural substance, drug or device. If a generic drug is dispensed, the manufacturer's name must be included.
3. The dispensing doctor enters into the patient's medical record the name and strength of the natural substance, drug or device dispensed, the date the natural substance, drug or device is dispensed and the therapeutic reason.
4. The dispensing doctor keeps all prescription‑only drugs, controlled substances and prescription‑only devices in a secured cabinet or room, controls access to the cabinet or room by a written procedure and maintains an ongoing inventory of its contents.
B. Except in an emergency, a doctor of naturopathic medicine who dispenses a natural substance, drug or device without being certified to dispense by the board is subject to a civil penalty by the board of not less than three hundred dollars and not more than one thousand dollars for each transaction and may be prohibited from further dispensing for a period of time as determined by the board.
C. Before dispensing a natural substance, drug or device pursuant to this section, the treating doctor shall give the patient or the patient's legal guardian a written prescription and must inform the patient or the patient's legal guardian that the prescription may be filled by the prescribing doctor or the pharmacy of the patient's choice. If the patient chooses to have the medication dispensed by the doctor, the doctor must retrieve the written prescription and place it in a prescription file kept by the doctor.
D. A doctor of naturopathic medicine shall provide direct supervision of a nurse or attendant involved in the dispensing process. For the purposes of this subsection, "direct supervision" means that a doctor of naturopathic medicine is present and makes the determination as to the necessary use or the advisability of the natural substance, drug or device to be dispensed.
E. The board shall enforce this section. The board shall adopt rules regarding the dispensing of a natural substance, drug or device, including the labeling, record keeping recordkeeping, storage and packaging of natural substances, that are consistent with the requirements of chapter 18 of this title. The board may conduct periodic inspections of dispensing practices to assure ensure compliance with this section and applicable rules.
F. This section does not prevent a licensed practical or professional nurse employed by a doctor of naturopathic medicine from assisting in the delivery of natural substances, drugs and devices in accordance with this chapter.
G. Before prescribing or dispensing a mineral to a patient, the treating physician shall perform necessary clinical examinations and laboratory tests to prevent toxicity due to the excessive intake of magnesium, calcium and other minerals. The board shall adopt rules necessary for the safe administration of minerals. These rules shall require prior certification of a physician who prescribes or dispenses minerals to a patient.
H. For the purposes of this section:
1. "Device" means an appliance, apparatus or instrument that is administered or dispensed to a patient by a doctor of naturopathic medicine.
2. "Dispense" means the delivery by a doctor of naturopathic medicine of a natural substance, drug or device to a patient and only for a condition being diagnosed or treated by that doctor, except for free samples packaged for individual use by licensed manufacturers or repackagers, and includes the prescribing, administering, packaging, labeling and security necessary to prepare and safeguard the natural substance, drug or device for delivery to the treating doctor's own patient."
Renumber to conform
Amend title to conform