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NOTICE OF FINAL RULEMAKING
TITLE 4. PROFESSIONS AND OCCUPATIONS
CHAPTER 16. ARIZONA MEDICAL BOARD
[R19-04]
PREAMBLE
| 1. Article, Part, or Section Affected (as applicable) | Rulemaking Action |
| R4-16-101 | Amend |
| R4-16-102 | Amend |
| R4-16-103 | Amend |
| R4-16-401 | Amend |
| R4-16-402 | Amend |
2. Citations to the agency's statutory rulemaking authority to include both the authorizing statute (general) and the implementing statute (specific):
Authorizing statute: A.R.S. §§ 32-1404(D) and 32-1456(B) and (D)
Implementing statute: A.R.S. §§ 32-1401(16) and 32-1456
3. The effective date for the rules:
March 9, 2019
a. If the agency selected a date earlier than the 60-day effective date as specified in A.R.S. § 41-1032(A), include the earlier date and state the reason or reasons the agency selected the earlier effective date as provided in A.R.S. § 41-1032(A)(1) through (5):
Not applicable
b. If the agency selected a date later than the 60-day effective date as specified in A.R.S. § 41-1032(A), include the later date and state the reason or reasons the agency selected the later effective date as provided in A.R.S. § 41-1032(B):
Not applicable
4. Citation to all related notices published in the Register as specified in R1-1-409(A) that pertain to the record of the final rulemaking package:
Notice of Rulemaking Docket Opening: 24 A.A.R. 638, March 23, 2018
Notice of Proposed Rulemaking: 24 A.A.R. 1851, July 6, 2018
5. The agency's contact person who can answer questions about the rulemaking:
Name: Patricia McSorley, Executive Director
Address: Arizona Medical Board
1740 W. Adams St., Suite 4000
Phoenix, AZ 85007
Telephone: (480) 551-2700
Fax: (480) 551-2704
E-mail: patricia.mcsorley@azmd.gov
Web site: www.azmd.gov
6. An agency's justification and reason why a rule should be made, amended, repealed, or renumbered, to include an explanation about the rulemaking:
In a five-year-review report approved by the Council on December 5, 2017, the Board indicated it would amend the rules in this rulemaking. The rules regarding medical assistants are amended to update them with current industry standards. Minor, non-substantive, changes are made to the language of R4-16-101 though R4-16-103. An exemption from Executive Order 2018-02 was provided for this rulemaking by Emily Rajakovich, Director of Boards and Commissions, in an e-mail dated March 1, 2018.
7. A reference to any study relevant to the rule that the agency reviewed and either relied on or did not rely on in its evaluation of or justification for the rule, where the public may obtain or review each study, all data underlying each study, and any analysis of each study and other supporting material:
The Board did not review or rely on a study in its evaluation of or justification for any rule in this rulemaking.
8. A showing of good cause why the rulemaking is necessary to promote a statewide interest if the rulemaking will diminish a previous grant of authority of a political subdivision of this state:
Not applicable
9. A summary of the economic, small business, and consumer impact:
The Board expects the rulemaking to have minimal economic impact. The rulemaking simply amends the definition of approved medical assistant training program, updates the entities providing medical assistant examinations, updates material incorporated by reference, and makes the rule regarding CME consistent with recent statutory change.
10. A description of any changes between the proposed rulemaking, including supplemental notices, and the final rulemaking:
Between the proposed and final rulemaking, the Board made the changes described in item 11.
11. An agency's summary of the public or stakeholder comments made about the rulemaking and the agency response to comments:
The Board received written comments from Michael McCarty, legal counsel to American Medical Technologists; Dr. Michael Dunn; Dr. Patrick Hitchcock; Dr. Steven Perlmutter; Dr. A. Joseph Dawood; Monica Rodriguez; Lili Jordan; Dr. Ruth Letizia; Ian Rothwell; and Donald Balasa of the American Association of Medical Assistants (AAMA). Mr. Balasa also spoke at the oral proceeding held on August 14, 2018. His comments were supported by Mary Dockall, president of the Arizona Society of the AAMA.
| COMMENT | ANALYSIS | RESPONSE |
|---|---|---|
| R4-16-102(A)(1): Do not approve the rule. This change further codifies the new ridiculous extra CME punishment of Arizona physicians for simply having a DEA registration whether utilized daily or not utilized at all. The rule change is too cumbersome—represents a hardship. Make the proposed change every two or three years instead. |
Under Laws 2018, Chapter 1, the legislature added A.R.S. § 32-3248.02, which requires a health professional authorized to prescribe or dispense schedule II controlled substances to complete three hours of opioid-related, substance use disorder- related, or addiction-related continuing medical education during each license renewal cycle. The statutory requirement is to obtain three hours of the specified CME during each renewal cycle. A renewal cycle is two years. |
No change No change |
| R4-16-103(A)(4): There is a typographical error. The word "purposed" should be "purposes." |
The comment is correct. | The correction was made. |
| R4-16-103(H): No decision of the Board should absolutely preclude a physician from filing a motion for rehearing or review. |
This provision applies only if the Board makes a finding that a final decision is necessary to preserve public health, safety, or welfare. When the Board issues a final decision without opportunity for a review or rehearing, the party affected still has an opportunity to appeal to court under A.R.S. Title 12, Chapter 7, Article 6. |
No change |
| R4-16-401(A)(2): Insert "...a certifying organization accredited by..." because the named entities do not administer medical assistant certification examinations. Rather, they accredit certification programs, which require passing the examination. |
The comment is correct. | The suggested language was added to R4- 16-401(A)(2). |
| You might want to add a requirement for a full international criminal background check for all new foreign licensing applicants and a comprehensive test of the ability to write and speak English. Many of my patients note they cannot understand the doctor. |
This rulemaking is about medical assistants, who make no application and are not licensed by the Board. The rulemaking is not about physicians. |
No change |
| R4-16-402(A): Because the incorporated material is updated frequently, eliminate the provision that the incorporated material "does not include later amendments or editions." |
A.R.S. § 41-1028(B) of the Arizona Administrative Procedure Act requires agency rules to fully identify incorporated matter by date and "...shall state that the rule does not include any later amendments or editions of the incorporated matter." |
No change |
| R4-16-402(B): Add a provision that medical assistants may obtain intravenous access and administer intravenous fluids after successful completion of 10 hours of training and 10 documents supervised procedures. Because of the little training time required to become a medical assistant, I am uneasy having them provide treatments involving traction, ultrasound, or electronic galvation stimulations. An addendum listing the activities that may be performed by medical assistants rather than referring to the source would be helpful. Can a medical assistant remove/replace a urinary catheter and do IM injections? Are medical assistants permitted to do sterile urinary catheterization of the bladder? |
The Board determined the reference procedures, which are not among those identified in the materials incorporated by reference in R4-16-402, are not appropriate for medical assistants to perform. Because a medical assistant may perform a procedure does not mean the supervisor is required to allow the medical assistant to perform the procedure. Indeed, the supervisor has an obligation to ensure a medical assistant is able to correctly and safely perform any procedure delegated. The reason materials are incorporated by reference is to simplify a rule. Appendix B, as incorporated, can be downloaded and printed for use in your office. No. These procedures are not among those identified in the materials incorporated by reference in R4-16-402. No. This procedure is not among those identified in the materials incorporated by reference in R4-16-402. |
No change No change No change No change No change |
12. All agencies shall list any other matters prescribed by statute applicable to the specific agency or to any specific rule or class of rules. Additionally, an agency subject to Council review under A.R.S. §§ 41-1052 and 41-1055 shall respond to the following questions:
None
a. Whether the rule requires a permit, whether a general permit is used and if not, the reasons why a general permit is not used:
None of the rules requires a permit.
b. Whether a federal law is applicable to the subject of the rule, whether the rule is more stringent than federal law and if so, citation to the statutory authority to exceed the requirements of federal law:
None of the rules is more stringent than federal law. There are numerous federal laws relating to the provision of health care but none is directly applicable to this rulemaking.
c. Whether a person submitted an analysis to the agency that compares the rule's impact of the competitiveness of business in this state to the impact on business in other states:
No analysis was submitted.
13. A list of any incorporated by reference material as specified in A.R.S. § 41-1028 and its location in the rule:
R4-16-402: Appendix B, Core Curriculum for Medical Assistants, 2015 edition of Standards and Guidelines for the Accreditation of Educational Programs in Medical Assisting, published by the Commission on Accreditation of Allied Health Education Programs
14. Whether the rule was previously made, amended, or repealed as an emergency rule. If so, cite the notice published in the Register as specified in R1-1-409(AI. Also, the agency shall state where the text was changed between the emergency and the final rulemaking packages:
None of the rules was previously made, amended, or repealed as an emergency rule.
15. The full text of the rules follows:
TITLE 4. PROFESSIONS AND OCCUPATIONS
CHAPTER 16. ARIZONA MEDICAL BOARD
ARTICLE 1. GENERAL PROVISIONS
Section
R4-16-101. Definitions
R4-16-102. Continuing Medical Education
R4-16-103. Rehearing or Review of Board Decision
ARTICLE 4. MEDICAL ASSISTANTS
Section
R4-16-401. Medical Assistant Training Requirements
R4-16-402. Authorized Procedures for Medical Assistants
ARTICLE 1. GENERAL PROVISIONS
R4-16-101. Definitions
Unless the context otherwise requires, definitions prescribed under A.R.S. § 32-1401 and the following apply to this Chapter:
1. "ACLS" means advanced cardiac life support performed according to certification standards of the American Heart Association.
2. "Agent" means an item or element that causes an effect.
3. "Approved medical assistant training program" means a
program accredited by any one of the following:
a. The Commission on Accreditation of Allied Health Education Programs; or
b. The Accrediting Bureau of Health Education Schools; .
c. A medical assisting
program accredited by any accrediting agency recognized by the United States
Department of Education; or
d. A training
program:
i. Designed and offered
by a licensed allopathic physician;
ii. That meets or exceeds
any of the prescribed accrediting programs in subsection (a), (b), or (c);
and
iii. That verifies the
entry-level competencies of a medical assistant prescribed under
R4-16-402(A).
4 "Ausculation" means the
act of listening to sounds within the human body either directly or through use
of a stethoscope or other means.
5. 4. "BLS" means basic life support performed
according to certification standards of the American Heart Association.
6. 5. "Capnography" means monitoring the
concentration of exhaled carbon dioxide of a sedated patient to determine the
adequacy of the patient's ventilatory function.
7. 6. "Deep sedation" means a drug-induced
depression of consciousness during which a patient:
a. Cannot be easily aroused, but
b. Responds purposefully following repeated or painful stimulation, and
c. May partially lose the ability to maintain ventilatory function.
8. 7. "Discharge" means a written or electronic
documented termination of office-based surgery to a patient.
9. 8. "Drug" means the same as in A.R.S. §
32-1901.
10. 9. "Emergency" means an immediate threat to
the life or health of a patient.
11. 10. "Emergency drug" means a drug that is
administered to a patient in an emergency.
12. 11. "General Anesthesia" means a drug-induced
loss of consciousness during which a patient:
a. Is unarousable even with painful stimulus; and
b. May partially or completely lose the ability to maintain ventilatory, neuromuscular, or cardiovascular function or airway.
13. 12. “Health care professional” means a
registered nurse defined in A.R.S. § 32-1601, registered nurse practitioner
defined in A.R.S. § 32-1601, physician assistant defined in A.R.S. § 32-2501,
and any individual authorized to perform surgery according to A.R.S. Title 32
who participates in office-based surgery using sedation at a physician's
office.
14. 13. "Informed consent" means advising a
patient of the:
a. Purpose for and alternatives to the office-based surgery using sedation,
b. Associated risks of office-based surgery using sedation, and
c. Possible benefits and complications from the office-based surgery using sedation.
15. 14. "Inpatient" has the same meaning as in
A.A.C. R9-10-201.
16. 15. "Malignant hyperthermia" means a
life-threatening condition in an individual who has a genetic sensitivity to
inhalant anesthetics and depolarizing neuromuscular blocking drugs that occurs
during or after the administration of an inhalant anesthetic or depolarizing
neuromuscular blocking drug.
17. 16. "Minimal Sedation" means a drug-induced
state during which:
a. A patient responds to verbal commands,
b. Cognitive function and coordination may be impaired, and
c. A patient's ventilatory and cardiovascular functions are unaffected.
18. 17. "Moderate Sedation" means a drug-induced
depression of consciousness during which:
a. A patient responds to verbal commands or light tactile stimulation, and
b. No interventions are required to maintain ventilatory or cardiovascular function.
19. 18. "Monitor" means to assess the condition of
a patient.
20. 19. "Office-based surgery" means a
medical procedure conducted in a physician's office or other outpatient setting
that is not part of a licensed hospital or licensed ambulatory surgical
center (A.R.S. § 32-1401(20)).
21. 20. "PALS" means pediatric life support
performed according to certification standards of the American Academy of
Pediatrics or the American Heart Association.
22. 21. "Patient" means an individual receiving
office-based surgery using sedation.
23. 22. "Physician" has the same meaning as doctor
of medicine as defined in A.R.S. § 32-1401.
24. 23. "Rescue" means to correct adverse
physiologic consequences of deeper than intended level of sedation and return
the patient to the intended level of sedation.
25. 24. "Sedation" means minimum sedation,
moderate sedation, or deep sedation.
26. 25. "Staff member" means an individual
who:
a. Is not a health care professional, and
b. Assists with office-based surgery using sedation under the supervision of the physician performing the office-based surgery using sedation.
27. 26. "Transfer" means a physical relocation of
a patient from a physician's office to a licensed health care
institution.
R4-16-102. Continuing Medical Education
A. No change
1. The physician shall
ensure at least one of the credit hours of continuing medical education is
certified as Category 1, as described in subsection (B)(4), and addresses the
effective and safe prescribing of opioids A
physician who is authorized to prescribe schedule II controlled substances and
holds a valid U.S. Drug Enforcement Administration registration number shall
complete at least three hours of opioid-related, substance-use-disorder-related,
or addiction-related continuing medical education during each renewal
cycle;
2. No change
3. No change
B. No change
1. No change
2. No change
3. No change
4. No change
5. No change
6. No change
7. No change
a. No change
b. No change
8. No change
a. No change
b. No change
c. No change
d. No change
C. If a physician holding an active license to practice medicine in this state fails to meet the continuing medical education requirements under subsection (A) because of illness, military service, medical or religious missionary activity, or residence in a foreign country, upon written application, the Board shall grant an extension of time to complete the continuing medical education.
D. No change
R4-16-103. Rehearing or Review of Board Decision
A. A motion
for rehearing or review shall be filed as follows: In
a contested case or appealable agency action, a party aggrieved by an order of
the Board may file a written motion for rehearing or review with the Board under
A.R.S. Title 41, Chapter 6, Article 10, specifying the grounds for rehearing or
review.
1. Except as provided in
subsection (B), any party in a contested case may file a written motion for
rehearing or review of the Board's decision, specifying generally the grounds
upon which the motion is based.
2. 1. A motion for rehearing or review shall be
filed with the Board and served no later that than 30 days after the decision of the
Board.
3. 2. For purposes of this Section, "service" has
the same meaning as in A.R.S. § 41-1092.09.
4. 3. For purposes of this Section, a document is
deemed filed when the Board receives the document.
5. 4. For purposed purposes
of the this
Section, the terms "contested case"
and "party" shall have
has the same meaning as in A.R.S. §
41-1001.
B. If the
Board makes a specific finding that it is necessary for a particular decision to
take immediate effect to protect the public health and safety, or that a
rehearing or review of the Board's decision is impracticable or contrary to the
public interest, the decision shall be issued as a final decision without
opportunity for rehearing or review and shall be a final administrative decision
for purposes of judicial review. Except as provided in subsection (H), a party is
required to file a motion for rehearing or review of a Board decision to exhaust
the party's administrative remedies.
C. A written
response to a motion for rehearing or review may be filed and served within 15
days after service of the motion for rehearing or review. The Board may require
the filing of written briefs upon any issues raised in the motion and may
provide for oral argument. A
party may amend a motion for rehearing or review at any time before the Board
rules on the motion.
D. A
The Board may grant a rehearing or
review of a decision may be
granted for any of the following reasons materially affecting a party's
rights:
1. Irregularity in the administrative proceedings by
the Board, its hearing officer, or the prevailing party, or any ruling
or an order or abuse of discretion, that
deprives the moving party of a fair hearing;
2. Misconduct of the Board, its
hearing officer its staff,
administrative law judge, or the prevailing party;
3. Accident or surprise that could have not been prevented by ordinary prudence;
4. Material evidence,
newly Newly discovered, which material
evidence that could not, with reasonable diligence,
could not have been
discovered and produced at the original hearing:
5. Excessive or
insufficient penalties penalty;
6. Error in the admission or rejection of evidence, or other errors of law that
occurred occurring at the
hearing or during the progress of the
proceedings;
7. The decision is the result of a passion or prejudice; or
8. The decision
of findings of fact or decision is not justified by the evidence or is
contrary to law.
E. A
rehearing or review may be granted The
Board may grant a rehearing or review to all or any of the parties and on
all or part of the issues for any of the reasons in subsection (D). The Board
may take additional testimony, amend findings of fact and conclusions of law, or
make new findings and conclusions, and affirm, modify, or reverse the original
decision. The Board shall specify the
particular grounds for any order modifying a decision or granting a rehearing.
If a rehearing or review is granted, the rehearing or review shall cover only
the matters specified in the order.
F. A
rehearing or review, if granted, shall be a rehearing or review only of the
question upon which the decision is found erroneous. An order granting a
rehearing or review shall specify with particularity the grounds for the
order.
G.
Not later than 15 days after a decision is issued, the Board of
on its own initiative may order a
rehearing or review for any reason that it might have granted a rehearing or
review on motion of a party. After giving the parties notice and an opportunity
to be heard on the matter, the Board may grant a timely-served motion for a
rehearing or review, for a reason
not stated in the motion. In either case, the Board shall specify in the order
the grounds for the rehearing or review.
H. G. If a motion for rehearing or
review is based upon affidavits, they shall be served with the motion. The An opposing party may, within 15 days after
service, serve opposing affidavits. The Board may extend this period for a
maximum of 20 days either by the
Board for good cause, or
upon written stipulation by the parties
by written stipulation. The Board
may permit reply affidavits.
H. If, in a particular decision, the Board makes a specific finding that the immediate effectiveness of the decision is necessary for the preservation of the public health, safety, or welfare, the decision may be issued as a final decision without an opportunity for rehearing or review.
I. A party that has exhausted the party's administrative remedies may appeal a final order of the Board under A.R.S. Title 12, Chapter 7, Article 6.
J. A person that files a complaint with the Board against a licensee:
1. Is not a party to:
a. A Board administrative action, decision, or proceeding; or
b. A court proceeding for judicial review of a Board decision under A.R.S. §§ 12-901 through 12-914; and
2. Is not entitled to seek rehearing or review of a Board action or decision under this Section.
ARTICLE 4. MEDICAL ASSISTANTS
R4-16-401. Medical Assistant Training Requirements
A. A
After the effective date of this Section,
a supervising physician or physician assistant shall ensure that before
a medical assistant satisfies one of the
following training requirements before employing is
employed, the medical assistant completes
either:
1. Completion of an
approved medical assistant An
approved training program identified in
R4-16-101; or
2. Completion of
an An unapproved medical assistant training program and
passage of successfully
passes the medical assistant examination administered by a
certifying organization accredited by either the American
Association of Medical Assistants or the American Medical Technologists
National Commission for Certifying
Agencies or the American National Standards Institute.
B. This Section does not apply to any person who:
1. Before February 2, 2000:
a. Completed an unapproved medical assistant training program and was employed as a medical assistant after program completion; or
b. Was directly supervised by the same physician, physician group, or physician assistant for a minimum of 2000 hours; or
2. Completes a United States Armed Forces medical services training program.
R4-16-402. Authorized Procedures for Medical Assistants
A. A medical assistant may perform, under the direct
supervision of a physician or a physician assistant, the medical procedures
listed in the 2003 revised Appendix B, Core Curriculum for Medical
Assistants, 2015 edition of Standards and
Guidelines for the Accreditation of Educational Programs in Medical
Assisting, published by the Commission
on Accreditation of Allied Health Education Program's, Programs
"Standards and Guidelines for an
Accredited Educational Program for the Medical Assistant, Section (III)(C)(3)(a)
through (III)(C)(3)(c)."
This material is incorporated by reference, does not include any
later amendments or editions of the
incorporated matter, and may be obtained from the publisher at 35 East Wacker Drive, Suite 1970, Chicago, Illinois
60601 25400 U.S. Highway 19 N,
Suite 158, Clearwater, FL 33763, www.caahep.org, or the Arizona
Medical Board at 9545 E.
Doubletree Ranch Road, Scottsdale, AZ 85258, www.azmd.gov.
B. In addition to the medical procedures in subsection (A), a medical assistant may administer the following under the direct supervision of a physician or physician assistant:
1. Whirlpool treatments,
2. Diathermy treatments,
3. Electronic galvation stimulation treatments,
4. Ultrasound therapy,
5. Massage therapy,
6. Traction treatments,
7. Transcutaneous Nerve Stimulation unit treatments,
8. Hot and cold pack treatments, and
9. Small volume nebulizer treatments.