RULE 800 

COLORADO BOARD OF MEDICAL EXAMINERS RULES REGARDING THE DELEGATION AND SUPERVISION OF MEDICAL SERVICES TO UNLICENSED HEALTH CARE PROVIDERS PURSUANT TO § 12-36-106(3)(l), C.R.S. 

I. INTRODUCTION 

A. 	Basis. The general authority for promulgation of these Rules by the State Board of Medical Examiners is set forth in §§ 12-36-104(1)(a), C.R.S. and 24-4-103, C.R.S. 

B. 	Purpose. The following Rules have been adopted by the State Board of Medical Examiners to clarify the provisions of § 12-36-106(3)(l), C.R.S. regarding the delegation of medical services to and personal and responsible direction and supervision over a person who is not otherwise exempt pursuant to § 12-36-106, C.R.S. from holding a license to practice medicine. Additionally, these Rules clarify particular requirements applicable to the delegation of medical services pursuant to § 12-36-106(3)(l), C.R.S. when the delegatee is performing Medical-Aesthetic Services as defined in Section II(F) of these Rules. 

C. 	Under the personal and responsible direction and supervision of a person licensed under the laws of this State to practice medicine, a license to practice medicine is not required for the rendering of services, other than the prescribing of drugs, by persons qualified by experience, education, or training. Nothing in this exemption, however, shall be deemed to extend or limit the scope of any license, and this exemption shall not apply to persons otherwise qualified to practice medicine but not licensed to so practice in this State. § 12-36-106(3)(l), C.R.S. 

II. RULES 

A. 	Applicability and eligibility for delegation of medical services: 

1. 	These Rules apply to the delegation of services constituting the practice of medicine to a person who is not otherwise exempt pursuant to § 12-36-106, C.R.S. from holding a license to practice medicine. Therefore, these Rules do not apply to any person who is otherwise exempt pursuant to § 12-36-106, C.R.S. from holding a license to practice medicine and who is practicing within the scope of practice specified by the person’s specific exemption under § 12-36-106, C.R.S. These Rules also do not apply to a person performing services that do not constitute the practice of medicine as defined by the Medical Practice Act. 

For example, a registered nurse rendering nursing services or delegated medical functions pursuant to the Nurse Practice Act would not be bound by these Rules.  Also by way of example, a licensed dentist practicing dentistry as defined by article 35 of title 12, C.R.S. is not construed to be performing delegated medical services as set forth in § 12-36-106(3)(l), C.R.S. and would not be bound by these Rules. 

2. 	These Rules do not apply to the delegation of nursing tasks by a nurse in compliance with § 12-38-132, C.R.S. and the Board of Nursing Rules related to such delegation. 

3. 	Medical services shall not be delegated to the following individuals: 

a. 	Any person who is otherwise qualified to be licensed by the Board to practice medicine but who is not so licensed, including, but not limited to, any physician with an inactive, lapsed, revoked, restricted, limited, suspended or surrendered license, any physician who meets all qualifications for licensure but who is not licensed in Colorado, and any physician whose application for licensure in the State of Colorado has been denied unless the denial is pursuant to §  12-36-116(1)(a), C.R.S. 

b. 	Any person who is otherwise qualified to be licensed by the Board as a physician assistant but who is not so licensed, including, but not limited to, any physician assistant with an inactive, lapsed, revoked, restricted, limited, suspended or surrendered license and any physician assistant who meets all qualifications for licensure but who is not licensed in Colorado, and any physician assistant whose application for licensure in the State of Colorado has been denied unless the denial is pursuant to §  12-36-116(1)(a), C.R.S.
 
c. 	Section 12-36-106(3)(l), C.R.S. shall not be deemed to extend or limit the scope of any license and may not be used to circumvent the revocation, suspension, surrender, restriction, limitation, inactivation, non-renewal or denial of a license to practice any field of the healing arts in the State of Colorado. 

d. 	Any person who holds a physician training license pursuant to § 12-36-122, C.R.S.
 
4. 	Section 12-36-122(7)(c), C.R.S. provides in part that physician training licensees do not have the authority to delegate medical services to a person who is not licensed to practice medicine pursuant § 12-36-106(3)(l), C.R.S. 

5. 	Medical services shall not be delegated to an emergency medical technician (“EMT”) in a prehospital care environment acting beyond the EMT acts allowed. Instead, pursuant to Board Rule 500, a medical director of an EMT in a prehospital care environment must apply to the Board for a waiver to allow additional medical acts for the EMT under the medical director’s supervision in specific circumstances. In an office or hospital setting, it is not necessary to apply for a waiver pursuant to Board Rule 500 so long as the use of an EMT as a delegatee is in compliance with these Rules. 

B. 	Definition of “Services” as the term is used in § 12-36-106(3)(l), C.R.S.:
 
1. 	As provided by the Medical Practice Act, “services” generally include suggesting, recommending, prescribing, or administering any form of treatment, operation, or healing for the intended palliation, relief, or cure of any physical or mental disease, ailment, injury, condition or defect of any person. 

2. 	The definition of medical services under the Medical Practice Act does not encompass the gathering of data. Medical services also do not include acting as an intermediary by communicating a physician’s message or order to another person. 

3. 	Delegated services under § 12-36-106(3)(l), C.R.S. cannot include the prescribing of drugs. The ordering of a prescription refill by a delegatee does not constitute “the prescribing of drugs” provided that: 

a. 	the prescription refill is ordered at the same dose and for the same medication as the original prescription for that patient; and  

b. 	the prescription refill is ordered pursuant to a written protocol-driven refill procedure developed by one or more supervising physician(s). 

4.	As further delineated in Section II(F) of these Rules, Medical-Aesthetic Services performed by a delegatee must be performed pursuant to these Rules, and additionally must comply with the particular requirements set forth in Section II(F) of these Rules.

5.  	A physician may only delegate services that the physician is qualified and insured to perform, and services that the physician has not been legally restricted from performing.  Delegated services must be consistent with the delegating physician’s education, training, and experience.  The delegated services should be within a specialty area included in the delegating physician’s active medical practice.  That is, at least a substantial portion of the delegating physician’s active medical practice must include the personal performance of services within the same specialty area as the delegated services. 

6.	Delegated services must be of the type that a reasonable and prudent physician would find within the scope of sound medical judgment to delegate; therefore, delegated services should be routine, technical services not requiring the special skills of a licensed physician.   

7. 	Delegated services cannot be subsequently delegated to another party by the delegatee. 

C. 	Definition of “qualified by education, training or experience” as the phrase is used in § 12-36-106(3)(l), C.R.S.: 
1. 	It is the responsibility of the physician to ensure that the delegatee has the necessary education, training or experience to perform the delegated services. 

2. 	Upon request, the delegatee’s qualifications shall be documented in writing and provided to the Board. Such documentation may include, but not be limited to, copies of diplomas, certificates or professional degrees from bona fide training program(s) appropriate to the specific services delegated; documentation of direct observation of the repeated and successful performance of the delegated services; and/or appropriate credentialing by a bona fide agency or institution. 

3. 	Any person holding a license, certification or registration may not perform medical services beyond the scope of that license, certification, or registration unless the person has additional education, training or experience qualifying the person to perform the medical service in question and the delegation of the medical service is in compliance with these Rules. 

D. 	Definition of “personal and responsible direction and supervision” as the phrase is used in § 12-36-106(3)(l), C.R.S.: 

1. 	One or more physicians shall have explicitly agreed, although not necessarily in writing, to provide the necessary direction and supervision of the delegatee(s). 

2. 	All delegating physicians are accountable for the acts of the delegatee(s). 

3. 	The direction and supervision shall be sufficient to limit the need for the exercise of the judgment required of a physician, and to provide ongoing inspection, evaluation, advice and control. The physician must make decisions as to the necessity, type, effectiveness and method of treatment, and must devote sufficient time to on-the-spot inspection to determine that the physician’s directions are regularly being followed. 

4. 	Delegated services should be provided in the context of an appropriate physician/patient relationship. Ongoing care of a particular patient without direct physician involvement is inappropriate. Factors establishing the presence of an appropriate physician/patient relationship include, but are not limited to, physician performance of an initial consultation with the patient, direct observation by the physician of delegated services rendered by the delegatee, review by the physician of care rendered to the patient by the delegatee, review by the physician of outcomes following the performance of delegated services, and other active physician involvement in the provision, review and documentation of services provided by the delegatee.  Further, in the event of an adverse outcome, the delegating physician must provide appropriate follow-up care and/or referrals.

5.  	The delegating physician must monitor the quality of the services provided by the delegatee.

6. 	It is the responsibility of the delegating physician to provide personal and responsible direction and supervision that is consistent with generally accepted standards of medical practice.  Any services rendered by the delegatee will be held to the same standard that would be applied were the delegating physician to perform the services personally.  
7. 	Except as provided below, a physician must be on the premises and readily available to provide adequate personal and responsible direction and supervision. 

8. 	Where a delegatee is acting pursuant to specific and detailed written protocols and where adequate written emergency protocols are in place, the presence of the delegating physician on the premises may not be necessary. However, a delegating physician must be available to attend to the patient in person within thirty (30) minutes. 

9. 	As provided by §  12-36-117(1)(m)(I), C.R.S., a physician may not practice medicine as the partner, agent or employee or in joint venture with any person who does not hold a license to practice medicine in Colorado.  

10. 	A delegating physician shall assure that there is a timely chart note for all patient contacts. 

E. 	Identification of authority to act:

1. 	The delegating physician should provide information to patients regarding delegatees in the physician’s practice.
 
2. 	The delegating physician and the delegatee shall take appropriate measures to assure that delegatees are identified in a manner that prevents confusion as to the delegatees’ qualifications and legal authority to provide medical services. Following are examples of situations in which confusion as to the delegatees’ qualifications and legal authority to provide medical services is likely and in which the physician and the delegatee shall be responsible for taking effective measures to prevent such confusion. This list is illustrative and not exhaustive. 

a. 	A delegatee inappropriately uses the title “nurse;” 

b. 	A delegatee acting as an EMT or paramedic uses the title EMT or paramedic outside of the prehospital care setting, such as the emergency room; 

c. 	A delegatee uses a title such as “radiology practitioner assistant” and/or the acronym “RPA”, which is easily confused with the title of a licensed physician assistant or PA; 

d. 	A delegatee uses the word “licensed” as part of a title when the delegatee does not possess a Colorado license to perform the medical services at issue; or 

e. 	A delegatee uses the word “doctor” or the abbreviation “Dr.” when acting as a delegatee. 

F.	Additional provisions applicable to the delegation of Medical-Aesthetic Services.

1.	The Board finds that the delegation of medical services in the area of Medical-Aesthetic Services involves a broad range of changing technologies and practices, and is an area in which insufficient personal and responsible delegation and supervision of medical services has led to public safety concerns in Colorado and nationwide. Public safety concerns have also been identified by the Colorado Office of Barbers and Cosmetology Licensure, which has referred several cases of concern to the Board.  Representatives of the Colorado Office of Barbers and Cosmetology Licensure have appeared before the Board on more than one occasion to address public safety concerns stemming from improper or inadequate physician delegation of Medical-Aesthetic Services, poor outcomes and the difficulty in identifying whether appropriate equipment is used in this field under appropriate supervision.  These representatives have also reported that many practitioners in this field use devices that are not approved by the Food and Drug Administration, or devices that have been altered from their approved form.  The risks inherent in these elective Medical-Aesthetic medical services are such that enhanced supervision is needed to protect the public.  Finally, the Board is concerned with fraudulent practices in this field, including the sham or inadequate supervision provided to many delegatees rendering Medical-Aesthetic services.

2.	“Medical-Aesthetic Services” are medical services in the cosmetic or aesthetic field that constitute the practice of medicine.  Such Medical-Aesthetic Services include, but are not limited to: (a) the use of a laser, radio-frequency device, intense pulsed light, or other technique that results in the revision, destruction, incision or other structural alteration of human tissue and/or for hair removal; and (b) the performance of injections of Botox, Collagen, Restyline, or any other substance.

3.	In addition to the other requirements for personal and responsible direction and supervision of delegatees set forth above, the personal and responsible direction and supervision of delegatees performing Medical-Aesthetic Services must include the following: 

a.	The delegating physician and the delegatee 
must have a written agreement documenting the relationship between the delegating physician and the delegatee.  A sample written agreement is attached as Appendix A.

b.	The delegating physician must establish an  appropriate physician-patient relationship with each patient evaluated or treated by any delegatee performing Medical-Aesthetic Services.  To establish an appropriate physician-patient relationship, the delegating physician must personally assess each patient prior to and during the course of the performance of Medical-Aesthetic Services.  In the event of an adverse outcome, the delegating physician must provide appropriate follow-up care and/or referrals.

c.	On at least a weekly basis, the delegating physician must monitor the quality of the services provided by the delegatee through such means as direct observation, review of care, review of outcomes, review of equipment and/or review of protocols and procedures.

d.	The delegating physician shall maintain documentation of the physician’s ongoing physician-patient relationship with each patient, and of the monitoring of the quality of the services rendered consistent with the requirements described above.

G. 	Unlicensed practice of medicine. 

1. 	Pursuant to § 12-36-106(2), C.R.S., any person who performs any of the acts constituting the practice of medicine as defined by § 12-36-106(1), C.R.S. and who is not licensed by the Board to practice medicine or exempt from licensure requirements by some provision of § 12-36-106 shall be deemed to be practicing medicine without a license. No person shall be exempt from medical licensure requirements pursuant to §  12-36-106(3)(l), C.R.S., unless such person is acting in conformance with these Rules.  

2. 	A person who practices medicine without a license may be the subject of injunctive proceedings by the Board in the name of the People of the State of Colorado pursuant to § 12-36-132, C.R.S.  Such person may also be held criminally liable pursuant to § 12-36-129(1), C.R.S.
 
H. 	Unprofessional conduct. 

1. 	It shall be unprofessional conduct pursuant to § 12-36-117(1)(u), C.R.S. for any licensee to have delegated medical services or to have performed delegated medical services pursuant to § 12-36-106(3)(l), C.R.S. without complying with the provisions of these Rules. 

2. 	It shall also be unprofessional conduct pursuant to § 12-36-117(1)(u), C.R.S. for any person who is not licensed by this Board but who applies for licensure by this Board to have performed delegated medical services or to have delegated medical services pursuant to § 12-36-106(3)(l), C.R.S. prior to licensure in Colorado. 

						BOARD RULE 800, APPENDIX A

Agreement Between Delegating Physician
and Delegatee Performing 
Medical-Aesthetic Services
in Compliance with Board of Medical Examiners Rule 800

___________________________________________________________ and 
                                  (Print Name & Title of Delegating Physician)
___________________________________________________________, certify that:
                                  (Print Name & Title of Delegatee)

The delegating physician is licensed in the state of Colorado to practice medicine.

The delegating physician is acting as the authorized medical director for the delegatee.

The delegating physician is qualified and insured to perform the delegated services below.

The delegating physician is insured to delegate the delegated services below.

The delegating physician is not legally restricted from performing the delegated services below.

The delegating physician is providing personal and responsible direction and supervision to the delegatee by:

•	Being on the premises or readily & adequately available or
•	Being within a 30 minute response time of attending to a patient in person if:
o	Specific detailed written protocols are in place for the delegated services.
o	Emergency medical plans are in place.
•	Providing ongoing inspection, evaluation, advice and control over the delgatee/delegated services.
•	Devoting sufficient time to on-the-spot inspections to determine if physician directions are being followed.
•	Developing an appropriate physician-patient relationship with each patient evaluated or treated by any delegatee by:
o	Personally assessing each patient prior to and during the course of the performance of medical-aesthetic services.
o	Providing appropriate follow-up care and/or referrals in the event of an adverse outcome.
o	Monitoring the quality of the services provided by the delegatee on at least a weekly basis.
o	Maintaining documentation of the physician’s ongoing physician-patient relationship with each patient and of the monitoring of the quality of services rendered.
•	Otherwise conforming with all requirements of Board of Medical Examiners Rule 800.
 
The delegating physician will assure timely chart notes for all patient contacts of the delegated services.

The delegating physician will ensure that the delegatee has the necessary education, training or experience to perform the delegated services and can provide written documentation of such, should the medical board request it.

The delegating physician and delegatee agree to comply with all provisions of the Board of Medical Examiners Rule 800.

The delegating physician is delegating the following services and understands that (s)he is fully accountable for the performance of these services by the delegatee.

	__________________________	__________________________
	__________________________	__________________________
	__________________________	__________________________
	__________________________	__________________________

It is expressly agreed that the delegatee will only provide services for the delegated services listed in this document, unless the delegatee is separately licensed or otherwise legally authorized to provide such services.  

This agreement shall remain in effect until formally rescinded in writing by either party.

________________________________	_________________________________
(Signature & Title of Delegating Physician)			  (Signature of Delegatee)

Adopted 11/15/02, Effective 1/30/03; Revised 04/14/05, Effective 06/30/05; Revised 10/13/05, Effective 11/30/05, Revised 5/11/06, Effective July 2, 2006; Repealed and Readopted 11/15/07, Effective