COLORADO DEPARTMENT OF REGULATORY AGENCIES

Division of Professions and Occupations
Office of Naturopathic Doctor Registration Program

4 CCR 749-1

RULES REGULATING NATUROPATHIC DOCTORS REGISTRATION, PRACTICE, AND DISCIPLINE

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 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 7 - Medicines and devices used in the practice of naturopathic medicine

Purpose: The purpose of this rule is to clarify the obtaining, administering, and dispensing of prescription and nonprescription medications and devices for registered Naturopathic Doctors.

A.	The Director has approved the Naturopathic Formulary and methods as set forth in Section B of this Rule 7 for prescription and nonprescription medications and devices which may be used by a Naturopathic Doctor in the practice of naturopathic medicine pursuant to sections 12-37.3-102(11) and (12) and 12-37.3-105(1)(c), C.R.S. 

B.	NATUROPATHIC FORMULARY

MEDICATION/DEVICE	METHOD	
Epinephrine	Obtain, administer and  dispense to 
treat anaphylaxis only	
Oxygen	Obtain and administer for emergency use only	
Vaccines	Obtain and administer in accordance with current ACIP guidelines for patients who are at least eighteen years of age	
Local Anesthetics 

For example, and not by way of limitation:
•	Procaine
•	Tetracaine
•	Chloroprocaine
•	Lidocaine
•	Mepivicaine
•	Bupivicaine
•	Ropivicaine
•	Prilocaine
•	Ethyl-chloride
	Obtain and administer in connection with minor office procedures as defined in section 12-37.3-102(8), C.R.S.
	
Local Anesthetics, with Epinephrine

For example, and not by way of  limitation:
•	Procaine
•	Tetracaine
•	Chloroprocaine
•	Lidocaine
•	Mepivicaine
•	Bupivicaine
•	Ropivicaine
•	Prilocaine
•	Ethyl-chloride
	Obtain and administer in connection with minor office procedures as defined in section 12-37.3-102(8), C.R.S.
	
Topical Antiseptics
	Obtain and administer in connection with minor office procedures as defined in section 12-37.3-102(8), C.R.S.
	
Sterile Water	Obtain and administer in connection with minor office procedures as defined in section 12-37.3-102(8), C.R.S.
	
Normal Saline	Obtain and administer in connection with minor office procedures as defined in section 12-37.3-102(8), C.R.S.
	
Vitamin B6	Obtain and administer 	
Vitamin B12	Obtain and administer 	
Homeopathic Preparations
	Obtain, dispense,  and administer preparations prepared in accordance with the Homeopathic Pharmacopoeia of the United States Revision Service

FDA Regulated Non-prescription Medications 
	Obtain, dispense,  and administer	
Barrier Contraceptives 
For example, and not by way of limitation:
•	Condoms
•	Diaphragm
•	Cervical cap
•	Spermicidal Sponges, foam, and film

Barrier Contraceptives does NOT include intrauterine devices
	Obtain, fit, and dispense	
FDA Regulated Non-prescription Devices

	Obtain and dispense	

C.	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.

Rule 8 - Definitions

Purpose: The purpose of this rule is to define terms used in these Rules and the Naturopathic Doctor Act.

A.	“ACIP” means the Advisory Committee on Immunization Practices to the Centers for Disease Control and Prevention in the federal Department of Health and Human Services or its successor entity.

B.	“Administer” shall have the same meaning as the definition set forth in section 12-37.3-102, C.R.S., and means the direct application of a drug to the body of a patient by injection, inhalation, ingestion, or any other method.

C.	“Collaborative Agreement” means a written agreement executed between a Naturopathic Doctor and a Colorado licensed physician who is a pediatrician or a family physician.  The agreement shall include the duties and responsibilities of each party as part of the collaborative agreement according to each party’s standard of care and practice act.  The agreement shall include a process for consulting with and referring to a licensed physician to facilitate the effective treatment of children under the age of two years.   

D.	“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.

E.	“Dispense” shall have the same meaning as the definition set forth in section 12-37.3-102(5.5), C.R.S., and means the preparation, in a suitable container appropriately labeled for subsequent administration to or use by a patient, of a medicine that a Naturopathic Doctor is authorized to obtain.

F.	 “Licensed Pediatric Health Care Provider” means a licensed physician or advanced practice nurse who treats children.

G.	“Naturopathic Formulary” means the medications and devices listed in Rule 7 (Sections 12-37.3-102(11) and 12-37.3-105(1)(c), C.R.S.)

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)(e) and (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 16 – Treatment of Children Under Eight Years of Age

Purpose:  The purpose of this rule is to clarify the requirements for the treatment of children under eight years of age by a Naturopathic Doctor as set forth in sections 12-37.3-105(2)(e) and (f), C.R.S., and the reporting requirements associated with the treatment of children under two years of age set forth in section12-37.3-119, C.R.S.

A.	Children Under the Age of Two

1.	Provision of Immunization Schedule

a.   The Naturopathic Doctor shall provide to the parent or legal guardian of the child a copy of the most recent immunizations schedule recommended by the ACIP and recommend that the parent or legal guardian follow the immunizations schedule.

2.	Education Requirements

a.    As set forth in section 12-37.3-105(2)(e)(II)(A), C.R.S., a Naturopathic Doctor treating patients under two years of age must complete education and practicum training specific to pediatrics in accordance with continued professional competency requirements. 

b.	The continued professional competency requirements specific to treating children under two years of age are set forth in Rule 13 (C)(1)(c)(ii) or (E)(1)(b)(ii)(2) for deemed status.
 
3.	Collaborative Agreement Requirements 

a.	The Collaborative Agreement must:

i.	Be made in writing and signed by both the Naturopathic Doctor and the licensed physician identifying their respective license numbers, place of business, and phone numbers;

ii.	Contain the responsibilities and duties of each party;

iii.	Contain the process for the Naturopathic Doctor to consult with the licensed physician;

a)	The Collaborative Agreement must specify the anticipated means of communication and the expected frequency of consultation between the practitioners.

1)	Examples of “means” of communication include, but are not limited to, telephone, telehealth, or in person. 

2)	Examples of the expected “frequency” of the consultation include, but are not limited to, consultation for each child patient visit, consultation on an “as needed” basis, or regularly scheduled consultations on a weekly, monthly or quarterly basis.

b)	The Collaborative Agreement must specify an emergency protocol to be followed by the Naturopathic Doctor in the event a child’s condition warrants emergency treatment. 

iv.	Contain the process for the Naturopathic Doctor to refer a patient to a licensed physician to facilitate the patient’s effective treatment;

v.	Be kept on file by both the Naturopathic Doctor and the licensed physician for 7 years following the termination of the Collaborative Agreement or 7 years from the date the youngest child treated pursuant to the agreement reaches the age of majority, whichever occurs later.

b.	Within 30 days of the execution of the Collaborative Agreement, the Naturopathic Doctor shall provide, in writing, the licensed physician’s name and license number to the Director.  The Naturopathic Doctor shall inform the Director, in writing, of any change to the licensed physician’s information within 15 days of any such change.

c.	A sample collaborative agreement is provided in Appendix B.  Use of the sample form is not mandatory but any form must comply with statutory and rule requirements.

4.	Informed Consent
 
a.	The Naturopathic Doctor shall have each child’s parent or legal guardian sign an informed consent form that:

i.	Discloses that the Naturopathic Doctor is registered with the State of Colorado;

ii.	Discloses that the Naturopathic Doctor is not a physician licensed pursuant to Article 36 of Title 12; 

iii.	Recommends that the child have a relationship with a licensed pediatric health care provider; and 

iv.	If the child has a relationship with a licensed pediatric health care provider, the Naturopathic Doctor shall request permission from the parent or legal guardian to attempt to develop and maintain a Collaborative Relationship with the licensed pediatric health care provider.  If the child does not have a relationship with such a provider, the Naturopathic Doctor shall make a referral to at least one such provider on the child’s first visit.  

b.	In conjunction with Rule 11, a sample consent form is provided in Appendix A.  Use of the sample form is not mandatory but any form must comply with statutory and rule requirements.

5.	Reporting Requirements

a.	The Naturopathic Doctor shall provide the Collaborative Agreement to the Director upon request. 

b.	The Naturopathic Doctor shall collect, maintain and report the following data to the Director upon renewal:

i.	The number of children under the age of two years treated by the Naturopathic Doctor;

ii.	The conditions for which the children under the age of two years were treated by the Naturopathic Doctor; and,

iii.	The number and description of adverse events that occurred in connection with treatment of children under the age of two.

a)	“Adverse event” is defined as any harm to a child under two years of age that the treating Naturopathic Doctor is aware of and that resulted or likely resulted from the Naturopathic Doctor’s care of the child.  Reporting an adverse event to the Department does not, alone, constitute grounds for discipline under section 12-37.3-112, C.R.S. 

c.	Collaborative Agreement submissions; updates required to be reported under these rules; and, any adverse events shall be sent to the Director at dora_naturopathic_doctor@state.co.us.

B.	Children from Two Years of Age to Eight Years of Age

1.	Provision of the Immunization Schedule

a.	The Naturopathic Doctor shall provide to the parent or legal guardian of the child a copy of the most recent immunizations schedule recommended by the ACIP and recommend that the parent or legal guardian follow the immunizations schedule.

2.	Education Requirements

a.	As set forth in section 12-37.3-105(2)(e)(II)(B), C.R.S., a Naturopathic Doctor treating patients from  two years of age to eight years of age must complete education and practicum training specific to pediatrics in accordance with continued professional competency requirements. 

b.	The continued professional competency requirements specific to treating children under eight years of age are set forth in Rule 13 (C)(1)(c)(i) or (E)(1)(b)(ii)(1) for deemed status.

3.	Informed Consent

a.	The Naturopathic Doctor shall have each child’s parent or legal guardian sign an informed consent form that:

i.	Discloses that the Naturopathic Doctor is registered with the State of Colorado;

ii.	Discloses that the Naturopathic Doctor is not a physician licensed pursuant to Article 36 of Title 12;
 
iii.	Recommends that the child have a relationship with a licensed pediatric health care provider; and 

iv.	If the child has a relationship with a licensed pediatric health care provider, the Naturopathic Doctor shall request permission from the parent or legal guardian to attempt to develop and maintain a Collaborative Relationship with the licensed pediatric health care provider.

b.	In conjunction with Rule 11, a sample consent form is provided in Appendix A.  Use of the sample form is not mandatory but any form must comply with statutory and rule requirements.

History
Entire rule eff. 02/14/2014.

Rules 1.B.4, 7 – 12, Appendix A eff. 06/01/2014. Rule 10 eff. 08/30/2014
Rule 5 revised effective 06/30/2015

Rules 13, 14, & 15 effective 06/30/15

Rules 7, 8, 11 & 16, Appendix A and Appendix B effective 6/30/16

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, contact the Division at (303) 894-
7414 or find more information on how to file a complaint at: www.colorado.gov/pacific/dora/DPO_File_Complaint

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, or administer any prescription medications or devices except:
•	Epinephrine for anaphylaxis,
•	Vitamins B6 and B12
•	Barrier contraceptives (not including intrauterine devices),
•	Oxygen for  emergency use, and
•	Vaccines in accordance with ACIP guidelines for patients who are at least eighteen years of age.
•	Perform surgical procedures, including surgical procedures using a laser device.
•	Use general or spinal anesthetics, other than topical and local anesthetics, including anesthetics with epinephrine.
•	Administer ionizing radioactive substances for therapeutic purposes.
•	Treat a child who is less than two years old, unless:
(1)	This form is fully completed and signed;
(2)	The most recent immunization 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 legal guardian with this form, 
(3)	The Naturopathic Doctor develops and executes a written collaborative agreement with a licensed physician who is a pediatrician or family physician; and
(4)	The Naturopathic Doctor provides a release of information to the parent or guardian requesting permission to exchange information and enter into a collaborative relationship with the child’s licensed pediatric health care provider, if the child has one. 
•	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) The Naturopathic Doctor provides a release of information to the parent or guardian requesting permission to exchange information and enter into a collaborative relationship with the child’s licensed pediatric health care provider, if the child has one.
•	Practice medicine, surgery, or any other form of healing other than Naturopathic Medicine.
•	Practice obstetrics.
•	Perform chiropractic services (spinal adjustments, manipulation, or mobilization). Naturopathic physical medicine, as described in § 12-37.3-102(12)(b), C.R.S., is permitted.
•	Recommend the discontinuation of, 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 less than eight, with a licensed pediatric health care provider. If the patient is less than two and does not have a relationship with a licensed pediatric health care provider, I refer the patient to _____________________________(print name of licensed pediatric health care provider, physician, or advanced practice nurse who cares for pediatric patients).
4.   If the patient is a child aged less than eight, I have provided the immunization schedule that accompanies this form and 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:

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)(e) and (f), (3)(b), and 12-37.3-111, C.R.S., and all other laws applicable to Naturopathic Doctors.)

SAMPLE COLLABORATIVE AGREEMENT FOR THE TREATMENT OF CHILDREN UNDER TWO
(APPENDIX B)

The following parties agree to a collaborative arrangement in which the naturopathic doctor (ND) may consult with the Colorado licensed physician (pediatrician or family MD/DO) regarding patients under 2 years and refer to a physician. The purpose of this agreement is to facilitate the effective treatment of the patient.
Specific responsibilities of naturopathic doctor: _______________________________________________________________________________________
_______________________________________________________________________________________
Specific responsibilities of licensed physician: 
_______________________________________________________________________________________
_______________________________________________________________________________________
Process for consulting with licensed physician, including the means, e.g., in person, via phone, or via telehealth, and the frequency, e.g., per visit, on an as needed basis, or regularly scheduled on a weekly, monthly or quarterly basis): 
_______________________________________________________________________________________
_______________________________________________________________________________________
Process for referring the patient to a licensed physician to facilitate the effective treatment of the child:
_______________________________________________________________________________________
_______________________________________________________________________________________
Emergency plan: 
_______________________________________________________________________________________
_______________________________________________________________________________________
•	This agreement does not limit the ability of the ND to make an independent judgment.
•	This agreement does not require medical supervision of the ND by the physician.
•	Neither party assumes liability for the actions of the other.
•	The above parties do not have to be practicing in close proximity to one another.
•	This agreement will be kept on file in both parties’ respective patient file.
Naturopathic Doctor:
Name: _______________________________________________________________________________
Practice name: ________________________________________________________________________
Address: _____________________________________________________________________________
Phone number: _________________________________ Cell number: ___________________________
Fax: _________________________________________________________________________________
Email: _______________________________________________________________________________
Registration #: _________________________________________________________________________
Signature: ____________________________________________________________________________

Colorado Physician:
Name: _______________________________________________________________________________
Practice name: ________________________________________________________________________
Address: _____________________________________________________________________________
Phone number: _________________________________ Cell number: ___________________________
Fax: _________________________________________________________________________________
Email: _______________________________________________________________________________
License #: ____________________________________________________________________________
Signature: ____________________________________________________________________________