4 CCR 749-1
DEPARTMENT OF REGULATORY AGENCIES Division of Professions and Occupations – Office of Naturopathic Doctor Registration Program NATUROPATHIC DOCTORS REGISTRATION, PRACTICE, AND DISCIPLINE 4 CCR 749-1 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Authority Basis: These rules are promulgated pursuant to § 12-37.3-104(1)(a) C.R.S. The registration and regulation of Naturopathic Doctors is found in Title 12 ("Professions and Occupations"), Article 37.3 ("Naturopathic Doctors") of the Colorado Revised Statutes. Scope and purpose These rules were promulgated in order to carry out the powers and duties of the Division Director of the Division of Professions and Occupations, Department of Regulatory Agencies ("Director") pursuant to § 12-37.3-104(1)(a), C.R.S. These rules affect every person who practices as a Naturopathic Doctor in the State of Colorado.
Rule 1 - Process and form to report adverse actions by governmental agencies, convictions, judgments, civil actions, and illness or conditions ( § 12-37.3-112(1)(n),(o),(p)(I), C.R.S.) The purpose of this rule is to clarify the process and form for reporting adverse actions, convictions, and judgments to the Director as required in § 12-37.3-112(1)(n),(o),(p)(I), C.R.S. A. A registered Naturopathic Doctor shall report to the Director within 30 days of receiving a diagnosis of a physical or mental illness or condition that affects the naturopathic doctor’s ability to treat patients with reasonable skill and safety or that may endanger the health or safety of persons under his or her care.
B. Report contents 1. If the event is an adverse action by any governmental agency, the report to the Director must include the name of the agency, its jurisdiction, the case name, court docket, proceeding or case number by which the event is designated, and a copy of the consent decree, order, or decision.
2. If the event is a criminal conviction, the report to the Director must include the court, its jurisdiction, the case name, the case number, a description of the matter or a copy of the indictment or charges, and any plea or verdict entered by the court. Within 30 days of the imposition of sentence for a felony conviction, the registrant shall provide to the Director a copy of the imposition of sentence. Within 30 days of the completion of any terms of the sentence, the registrant shall provide written notice to the Director of the completion of the sentence terms, and any evidence of rehabilitation as described in § 24-5-101(4)(c), C.R.S.
3. If the event concerns a civil action or arbitration proceeding, the report to the Director must include the court or arbiter, the jurisdiction, the case name, the case number, a Code of Colorado Regulations 1 description of the matter or a copy of the complaint, and a copy of the verdict, the court or arbitration decision, or, if settled, the settlement agreement and court’s order of dismissal. 4. If the event concerns a physical or mental illness or condition: a. The initial report shall contain: the diagnosis and a description of the illness or condition; the date that the illness or condition was first diagnosed; the name of the current treatment provider and documentation from the current treatment provider confirming the diagnosis, date of onset, and treatment plan; and, a description of the Naturopathic Doctor’s practice and any modifications, limitations or restrictions to that practice that have been made as a result of the illness or condition.
b. The report of a change in condition shall contain: the date of the change in condition; the name of the current treatment provider and documentation from the current treatment provider confirming the change in condition, the date that the condition changed, the nature of the change in condition, and the current treatment plan; and, a description of the Naturopathic Doctor’s practice and any modifications, limitations or restrictions to that practice that have been made as a result of the change in condition.
c. Compliance with subsection a of this rule is a prerequisite for eligibility to enter into a confidential agreement with the Director pursuant to § 12-37.3-116(2)(a), C.R.S. however, mere compliance with this rule does not require the Director to negotiate regarding, or enter into, a confidential agreement. Rather, the Director will evaluate all facts and circumstances to determine if a confidential agreement is appropriate.
d. The failure to timely notify the Director of an illness or condition as required under this rule is a violation of § 12-37.3-112(1)(p)(I), C.R.S., constituting grounds for discipline and denial of a confidential agreement under § 12-37.3-116, C.R.S. C. In addition to any report required under this rule, the Naturopathic Doctor may also submit a written statement of explanation.
D. The report shall be submitted in writing to the Office of Naturopathic Doctor Registration by email, postal mail, fax, or online. Contact information may be found on the website or by calling the Division of Professions and Occupations ("Division").
Rule 2 - Duty to report change of contact information to the Director’s office ( § 12-37.3-104(1), C.R.S.)
The purpose of this rule is to establish and clarify the requirements for registrants to notify the Director of a change in contact information, as required for the administration of the program under § 12-37.3-104(1), C.R.S.
A. A registered Naturopathic Doctor shall report to the Office of Naturopathic Doctor Registration any name, address, telephone, or email change within 30 days of the change. B. The reporting shall be in writing through email, postal mail, fax, or on-line. Contact information may be found on the website or by calling the Division. Code of Colorado Regulations 2 Rule 3 - Declaratory orders ( § 24-4-105(11), C.R.S.)
The purpose of this rule is to establish procedures for the handling of requests for declaratory orders filed pursuant to the Colorado Administrative Procedure Act at § 24-4-105(11), C.R.S. A. Any person or entity may petition the Director for a declaratory order to terminate controversies or remove uncertainties as to the applicability of any statutory provision or of any rule or order of the Director.
B. The Director will determine, at the Director’s discretion and without notice to petitioner, whether to rule upon such petition. If the Director determines not to rule upon such a petition, the Director shall promptly notify the petitioner of the action and state the reasons for such decision. C. In determining whether to rule upon a petition filed pursuant to this rule, the Director will consider the following matters, among others:
1. Whether a ruling on the petition will terminate a controversy or remove uncertainty as to the applicability to petitioner of any statutory provisions or rule or order of the Director. 2. Whether the petition involves any subject, question or issue that is the subject of a formal or informal matter or investigation currently pending before the Director or a court involving one or more petitioners.
3. Whether the petition involves any subject, question or issue that is the subject of a formal or informal matter or investigation currently pending before the Director or a court but not involving any petitioner.
4. Whether the petition seeks a ruling on a moot or hypothetical question or will result in an advisory ruling or opinion.
5. Whether the petitioner has some other adequate legal remedy, other than an action for declaratory relief pursuant to Colorado Rules of Civil Procedure, Rule 57, which will terminate the controversy or remove any uncertainty as to the applicability to the petitioner of the statute, rule, or order in question.
D. A petition filed pursuant to this rule must set forth the following: 1. The name and address of the petitioner and whether the petitioner is registered pursuant to Title 12, Article 37.3 C.R.S.;
2. The statute, rule, or order to which the petition relates; and, 3. A concise statement of all of the facts necessary to show the nature of the controversy or uncertainty and the manner in which the statute, rule, or order in question applies or potentially applies to the petitioner.
E. If the Director decides to rule on the petition, the following procedures shall apply: 1. The Director may rule upon the petition based solely upon the facts presented in the petition. In such a case:
a. Any ruling of the Director will apply only to the extent of the facts presented in the petition and any amendment to the petition.
Code of Colorado Regulations 3 b. The Director may order the petitioner to file a written brief, memorandum, or statement of position.
c. The Director may set the petition, upon due notice to petitioner, for a non- evidentiary hearing.
d. The Director may dispose of the petition on the sole basis of the matters set forth in the petition.
e. The Director may request the petitioner to submit additional facts in writing. In such event, such additional facts will be considered as an amendment to the petition.
f. The Director may take administrative notice of facts pursuant to the Colorado Administrative Procedure Act at § 24-4-105(8), C.R.S., and may utilize the Director’s experience, technical competence, in the disposition of the petition. 2. If the Director rules upon the petition without a hearing, the Director will promptly notify the petitioner of the decision.
3. The Director may, at the Director’s discretion, set the petition for hearing, upon due notice to petitioner, for the purpose of obtaining additional facts or information or to determine the truth of any facts set forth in the petition or to hear oral argument on the petition. The hearing notice to the petitioner must set forth, to the extent known, the factual or other matters that the Director intends to inquire. For the purpose of such a hearing, to the extent necessary, the petitioner has the burden of proving all the facts stated in the petition; all of the facts necessary to show the nature of the controversy or uncertainty; and the manner in which the statute, rule, or order in question applies or potentially applies to the petitioner and any other facts the petitioner desires the Director to consider. F. The parties to any proceeding pursuant to this rule are the Director and the petitioner. Any other person may seek leave of the Director to intervene in such a proceeding, and leave to intervene will be granted at the sole discretion of the Director. A petition to intervene must set forth the same matters as are required otherwise in this Rule. Any reference to a "petitioner" in this rule also refers to any person who has been granted leave to intervene by the Director. G. Any declaratory order or other order disposing of a petition pursuant to this rule constitutes agency action subject to judicial review pursuant to the Colorado Administrative Procedure Act at § 24-4-106, C.R.S.
Rule 4 - Original registration ( § 12-37.3-106(2), C.R.S.) The purpose of this rule is to clarify the form and manner of an application for Naturopathic Doctor registration and clarify statutory requirements for registration pursuant to § 12-37.3-106(2), C.R.S. A. An applicant for registration must submit an application and all other required materials in the manner described by the Division within the Colorado Department of Regulatory Agencies. This information can be found on the Division website or by calling the Division. B. To qualify for registration as a naturopathic doctor a person must: 1. Be at least twenty-one years of age and of good moral character; Code of Colorado Regulations 4 2. Have obtained a baccalaureate degree from an accredited educational institution or documented experience that provides the same kind, amount, and level of knowledge as a Baccalaureate degree, as determined by the director;
3. Have graduated from and holds a doctor of naturopathic medicine or doctor of naturopathy degree from an approved naturopathic medical college; 4. Have successfully passed either a director-approved examination or a comprehensive competency-based national naturopathic licensing examination administered by the North American Board of Naturopathic Examiners or a nationally recognized, director-approved successor entity, as determined by the director by rule; and, 5. Have not had a license or other authorization to practice as a naturopathic doctor or other health care license, registration, or certification denied, revoked, or suspended by Colorado or any other jurisdiction for reasons that relate to the applicant's ability to skillfully and safely practice naturopathic medicine, unless the license, registration, or certification is reinstated to good standing by Colorado or another jurisdiction. Rule 5 - Inactive registration status ( § 12-37.3-118, C.R.S.) The purpose of this rule is to clarify the regulations governing inactive registration status pursuant to § 12- 37.3-118, C.R.S.
A. A registered naturopathic doctor shall request an inactive registration status by completing and submitting the appropriate application for Inactive Status. B. A naturopathic doctor with an inactive registration shall not engage in any act or conduct that constitutes the practice of naturopathic medicine.
C. Inactive registration status does not:
1. Prevent the Director from investigating complaints or imposing discipline against a naturopathic doctor in accordance with Title 12, Article 37.3 of the Colorado Revised Statutes; or, 2. Limit or restrict the Director’s functions, duties, or obligations, under Title 12, Article 37.3 of the Colorado Revised Statutes.
D. Except as otherwise provided by this rule, a naturopathic doctor with an inactive registration remains subject to all provisions of these rules and all provisions of Title 12, Article 37.3 of the Colorado Revised Statutes.
E. A naturopathic doctor may reactivate an inactive registration by: 1. Submitting a completed application for reactivation and paying a fee established by the Director;
2. Submitting proof, in a manner prescribed by the Director, that a naturopathic doctor license or registration held in another state or jurisdiction is in good standing; 3. Attesting that the applicant will, prior to practicing naturopathic medicine, maintain the professional liability insurance coverage required in statute; and, 4. Demonstrating compliance with the Director’s continuing professional competency rules with respect to registration reactivation.
Code of Colorado Regulations 5 Rule 6 - Armed services experience ( § 24-34-102(8.5), C.R.S.) The purpose of this rule is to clarify what and how Armed Services Experience will be considered for registration.
Education, training, or service gained in military services outlined in § 24-34-102(8.5), C.R.S., to be accepted and applied towards receiving a registration, must be substantially equivalent, as determined by the Director, to the qualifications otherwise applicable at the time of receipt of application. It is the applicant’s responsibility to provide timely and complete evidence for review and consideration. Satisfactory evidence of such education, training, or service will be assessed on a case by case basis. Rule 7 - Medicines and devices used in the practice of naturopathic medicine Purpose: The purpose of this rule is to clarify the use and administration of prescription and nonprescription medications for registered Naturopathic Doctors. A. The Director has approved the following formulary of prescription and nonprescription medications and devices a Naturopathic Doctor may use in the practice of naturopathic medicine pursuant to §§ 12-37.3-102(11), (12) and 12-37.3-105(1)(c), C.R.S. Naturopathic Formulary Prescription Medications and Devices Epinephrine to treat anaphylaxis Barrier contraceptives (excluding intrauterine devices) Nonprescription Medications And Devices Any nonprescription medications and devices appropriate within naturopathic medicine for treating patients B. When appropriate for the treatment of the patient, a Naturopathic Doctor may prescribe, order, procure, dispense, inject and administer nonprescription medications and devices, epinephrine to treat anaphylaxis, and barrier contraceptives, excluding intrauterine devices. C. Nonprescription homeopathic preparations prepared according to the most current version of the Homoeopathic Pharmacopoeia of the United States Revision Service, are authorized for use in naturopathic medicine.
D. A Naturopathic Doctor registered in Colorado shall not use a certification, registration, or license issued by another state to:
1. Issue prescription orders for prescription medications or devices to be dispensed by a pharmacy located in Colorado or in any other state for patients who the Naturopathic Doctor examines, diagnoses, or treats in Colorado, or 2. Prescribe, order, procure, dispense, inject or administer prescription medications or devices for general use with patients seen in his or her office in Colorado. Code of Colorado Regulations 6 Rule 8 - Definitions Purpose: The purpose of this rule is to define terms used in the Naturopathic Doctor act. A. “Collaborative Relationship” means a cooperative relationship among a patient’s health care providers; to share information and consult with one another as appropriate to achieve the best health care outcomes for the patient.
B. “Naturopathic Formulary” means the non-prescription medications authorized to be used in the practice of naturopathic medicine, epinephrine to treat anaphylaxis and barrier contraceptives, but excluding intrauterine devices. (§§ 12-37.3-102(11), 12-37.3-105(1)(c), C.R.S.) Rule 9 - Unregistered practice of naturopathic medicine Purpose: The purpose of this rule is to clarify acts that may constitute the unregistered practice of naturopathic medicine.
The Director of the Naturopathic Doctor Registration Program, or her designee, may discipline registered Naturopathic Doctors for violations of § 12-37.3-112(1), C.R.S., pursuant to §§ 12-37.3-112(10) through (13) and 12-37.3-113, C.R.S., the Director may issue cease and desist orders and seek other relief against unregistered persons who engage in conduct that requires registration as a Naturopathic Doctor. A. Acts that may constitute the unregistered practice of naturopathic medicine include but are not limited to:
1. Dispensing, administering, ordering, or prescribing a medicine or device that requires a prescription;
2. Diagnosing injury, disease, ailment, infirmity, deformity, pain, or another condition of the human body;
3. Using the title “Naturopathic Doctor,” “Doctor of Naturopathy,” or the abbreviation, “N.D.”; and 4. Performing minor office procedures as defined at § 12-37.3-102(8), C.R.S. B. Acts that do not constitute the unregistered practice of naturopathic medicine include but are not limited to:
1. Utilizing therapies that use nutritional supplements, herbs, foods, nonprescriptive homeopathic preparations, and physical forces such as heat, cold, water, touch, and light in the practice or provision of natural health care;
2. Using mind-body and energetic healing practices in the practice or provision of natural health care;
3. Providing information about or selling vitamins, health food, dietary supplements, herbs, or other natural products when otherwise permitted by state and federal law; 4. Providing truthful and non-misleading information regarding natural health care products or services.
C. Acts described in this rule that do not constitute the unregistered practice of naturopathic medicine may, under some circumstances, nevertheless be prohibited by laws other than the Naturopathic Doctor Act.
Code of Colorado Regulations 7 Rule 10 - Alternative qualifications for registration Purpose: The purpose of this rule is to clarify alternative qualifications for registration as a Naturopathic Doctor.
A. The Director may determine that completion of a four year post-graduate level didactic and supervised clinical educational program as described in § 12-37.3-106(4)(a), C.R.S., constitutes documented experience providing the same kind, amount, and level of knowledge as a four year baccalaureate degree required pursuant to § 12-37.3-106(2)(b), C.R.S. B. The director may determine that passage of an era-appropriate naturopathic licensing examination by an applicant who obtained a doctor of naturopathic medicine or doctor of naturopathy degree from an approved medical college prior to 1986 constitutes an exam that is substantially equivalent to that required in §12-37.3-106(2)(d), C.R.S., if such applicant for licensure:
1. Is currently certified, registered or licensed as a naturopathic doctor or naturopathic physician by a governmental agency in another state or territory, or 2. Has at least ten years of related professional experience in naturopathic medicine, as determined by the director, within the last 15 years immediately preceding the application for registration.
Rule 11 - Mandatory disclosures and forms Purpose: The purpose of this rule is to clarify the use of forms and disclosures the Director has determined as mandatory.
Sections 12-37.3-105(2)(f), (3)(b) and 12-37.3-111, C.R.S., require a Naturopathic Doctor to disclose certain information and obtain a signed consent from the patient before conducting an initial examination. A sample disclosure and consent form containing essential information which must be provided to the patient can be accessed in Appendix A. While use of the sample form is not mandatory, the form used must contain the information provided within the sample form and comply with the statutes referenced in this rule and other applicable laws.
Rule 12 - Record-keeping and patient records Purpose: The purpose of this rule is to clarify additional record-keeping and patient record management requirements as described in §§ 12-37.3-111 and 12-37.3-115(1)(a), C.R.S. A. Documentation of the patient’s health history (including pregnancy status, as applicable), presenting complaint(s), examination, diagnoses, prognoses, treatment recommendations, treatment, progression of care, prescriptions, lab results, xrays, correspondence, reports, and any health insurance records must be maintained in the patient record. B. Patient records are required to be contemporaneous, legible, utilize standard medical terminology or abbreviations, identify the patient, indicate all services rendered during each patient encounter, identify the provider of service, and indicate the date the service was performed. Any addition or correction to the patient record after entry shall be signed and dated by the person making the addition or correction.
C. Patient records shall be maintained for a minimum of seven (7) years after the last date of treatment or examination, or at least two (2) years after the patient reaches the age of eighteen (18), whichever occurs later. If patient records are maintained electronically, then a back-up and data recovery system must be in place.
Code of Colorado Regulations 8 D. When the destruction cycle for patient records is imminent, written notice to the patient’s last known address, or notice by publication, must be made sixty (60) days prior to destruction allowing a thirty (30) day period wherein the patient may claim his/her records. When a patient claims such records, the records must be provided to the patient, or legal guardian, at no charge; however, recovery of appropriate postage and handling costs is permitted. E. Patient records shall be destroyed in a manner that totally obliterates all information contained in the record such as by incinerating or shredding.
F. Patient records may not be withheld for outstanding/past due professional fees. A reasonable fee for copying records may be assessed to the requesting party. Appendix A - Naturopathic Doctor Disclosure Statement and Consent for Treatment Naturopathic Doctor Disclosure Statement and Consent for Treatment (Appendix A)
Naturopathic Doctor Name:
____________________________________________________________________________________ Business Address & Phone Number: _____________________________________________________ ____________________________________________________________________________________ The nature of the services the Naturopathic Doctor will be providing: ____________________________________________________________________________________ ____________________________________________________________________________________ ____________________________________________________________________________________ Naturopathic Doctors may be registered in other states. This Naturopathic Doctor is registered or licensed in the following state(s):_____________________________________________________________________________ Complaints regarding this Naturopathic Doctor must be submitted in writing to the Office of Naturopathic Doctor Registration. To obtain a complaint form, please contact the Division at (303) 894-7414 or find more information on how to file a complaint at:
http://www.dora.state.co.us/reg_investigations/file_complaint.htm. Naturopathic Doctors are registered by the state to practice naturopathic medicine under the “Naturopathic Doctor Act.” They are not permitted to perform the following acts: Prescribe, dispense, administer or inject any prescription medications or devices other than epinephrine for anaphylaxis and barrier contraceptives (not including IUDs). Perform surgical procedures, including surgical procedures using a laser device. Use general or spinal anesthetics, other than topical anesthetics. Administer ionizing radioactive substances for therapeutic purposes. Treat a child who is less than two years old.
Treat a child who is two years of age or older, but less than eight years of age, unless: (1) this form is fully completed and signed; (2) the most recent immunizations schedule recommended by the advisory committee on immunization practices to the centers for disease control and prevention in the federal department of health and human services is provided to the parent or guardian with this form; and (3) a release of information is provided to the parent or guardian requesting permission to exchange information with the child’s licensed pediatric health care provider, if the child has one. Code of Colorado Regulations 9 Practice medicine, surgery, or any other form of healing other than Naturopathic Medicine.
Practice obstetrics.
Perform chiropractic services (spinal adjustments, manipulation, or mobilization). Physical medicine, as described in § 12-37.3-102(12)(b), C.R.S., is permitted. Recommend the discontinuation or counsel against a course of care, including a prescription drug that was recommended by another health care practitioner licensed in Colorado, unless the Naturopathic Doctor consults with the health care practitioner. Disclosure Statement (To be completed by the Naturopathic Doctor) 1. I, __________________________________________ (print Naturopathic Doctor name), am a Naturopathic Doctor registered under Title 12, Article 37.3, of the Colorado Revised Statutes. 2. I am not a medical doctor or a physician licensed under Title 12, Article 36, of the Colorado Revised Statutes.
3. I recommend that the patient named below have a relationship with a licensed physician, or if the patient is a child aged two to seven, with a licensed pediatric health care provider. 4. If the patient is a child aged two to seven, I recommend that that the child’s parent or guardian follow the immunizations schedule that accompanies this form. 5. If the patient has a relationship with a licensed physician or pediatric health care provider, I will attempt to develop and maintain a collaborative relationship with the physician or pediatric health care provider. To permit this, the patient (or patient’s parent/guardian if patient is a minor) will need to sign a separate release allowing me to exchange information with the licensed physician or pediatric health care provider.
__________________________________________________ ________________________________ Naturopathic Doctor Signature Date Acknowledgement and Consent for Treatment (to be completed by the adult patient, or parent/guardian if patient is a minor)
I, __________________________________________ (print adult patient’s name, or if the patient is a minor, the parent or guardian name), acknowledge receipt of the above disclosure statement and give my informed consent for treatment for (circle one) myself or my child, __________________________________________ (print patient’s name) by the above named Naturopathic Doctor.
Check one:
The patient ___ does ___ does not have a relationship with a licensed physician or pediatric health care provider.
Name, address, phone of licensed physician or pediatric health care provider: ____________________________________________________________________________________ ____________________________________________________________________________________ ____________________________________________________________________________________ Code of Colorado Regulations 10 __________________________________________________ ________________________________ Signature of Patient/Parent or Guardian Date (This form must be completed and signed prior to the initial examination of the patient. If this form is altered, the form provided to the patient must contain all of the information detailed in this form, and comply with §§ 12-37.3-105(2)(f), (3)(b), and 12-37.3-111, C.R.S., and all other laws applicable to Naturopathic Doctors.)
________________________________________________________________________ Editor’s Notes History Entire rule eff. 02/14/2014.
Rule 10 emer. rule. eff. 05/23/2014.
Rules 1.B.4, 7 – 12, Appendix A eff. 06/01/2014.
Code of Colorado Regulations 11