DAR File No. 42785

This rule was published in the May 1, 2018, issue (Vol. 2018, No. 9) of the Utah State Bulletin.


Commerce, Occupational and Professional Licensing

Rule R156-71

Naturopathic Physician Practice Act Rule

Notice of Proposed Rule

(Amendment)

DAR File No.: 42785
Filed: 04/10/2018 01:29:44 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The Division of Occupational and Professional Licensing (Division) and the Naturopathic Physician Licensing Board are proposing the following amendments: in Section R156-71-102, the proposed changes are nonsubstantive changes in language to better identify the Council on Naturopathic Medical Education (CNME) and residency education requirements. In Subsection R156-71-202(1), the proposed changes update the American Society of Health System Pharmacists reference to include the current edition. Changes to the naturopath formulary were recommended by the Naturopathic Formulary Peer Committee and approved by the Board to add formulary references for non-controlled legend medications deemed appropriate for the scope of practice of naturopathic physicians.

Summary of the rule or change:

In Section R156-71-102, the proposed changes are nonsubstantive as they are grammatical corrections for the reference to the Council on Naturopathic Medical Education (CNME). In Subsection R156-71-202(1), the proposed changes update the naturopathic physician formulary. The reference for the formulary is the 2008 edition of the American Hospital Formulary Service (AHFS). This change allows practitioners to use the 2008 edition or to access the current edition on the AHFS Drug information website. The other changes to the subsection include updating the formulary to identify non-controlled legend medications that may be used by naturopathic physicians to provide improved patient care within the scope of practice. The changes were presented by the Naturopathic Physicians Formulary Peer Committee and approved by the Naturopathic Physicians Licensing Board.

Statutory or constitutional authorization for this rule:

  • Section 58-71-101
  • Subsection 58-1-106(1)(a)
  • Subsection 58-1-202(1)(a)

Anticipated cost or savings to:

the state budget:

No state agencies shall be directly or indirectly affected by these rule changes because the proposed amendments apply only to persons required to be licensed as a naturopathic physician in Utah. Additionally, there are no state government entities acting as businesses that will be impacted, and state government is not involved in the naturopathic formulary. Accordingly, this rule is not expected to impact the state beyond a minimal cost to the Division of approximately $75 to print and distribute the rule once the proposed amendments are made effective.

local governments:

These proposed amendments apply only to persons required to be licensed as a naturopathic physician in Utah. Additionally, there are no local governments acting as businesses that will be impacted, and local governments are not involved in the naturopathic formulary. Therefore, the Division estimates there will be no cost or savings impact on local governments.

small businesses:

These proposed amendments apply only to persons required to be licensed as a naturopathic physician in Utah. There are currently 80 naturopathic physician licensees in Utah; it is estimated that most operate private or group practices in their own offices, and that several operate in the facilities of others, such as hospitals or HMO medical centers (NAICS 621399). The change to Subsection R156-71-202(1) may result in a cost savings to these businesses because it allows naturopathic physicians to use the 2008 Edition of the AHFS Formulary or to access the Formulary online. Physicians needing to consult the formulary, therefore can avoid purchasing one, and use the online version. The formulary is not currently published; the 2008 edition is only available "used" and the price is market driven. The current online edition is available to naturopathic physicians through their association or by subscription. In addition, the changes allow the naturopathic physicians to utilize additional legend medications listed in the AHFS Formulary to treat human ailments within their scope of practice. However, the exact amount of any cost savings cannot be estimated because it is unknown how many naturopathic physicians will actually choose to use the online edition or utilize the additional legend medications. Next, the Naturopathic Physicians Licensing Board was polled to determine any foreseeable costs associated with these changes, and, together with a representative from the Utah Association of Naturopathic Physicians, the Board members unanimously found that there would be no fiscal cost.

persons other than small businesses, businesses, or local governmental entities:

These proposed amendments apply only to persons required to be licensed as a naturopathic physician in Utah. There are currently 80 naturopathic physician licensees in Utah. Similar to naturopathic physicians operating in small businesses, the Naturopathic Physicians Licensing Board has determined that there will be no fiscal cost to these individuals and any cost savings for individual naturopathic physicians cannot be estimated as the necessary data is unavailable.

Compliance costs for affected persons:

The Naturopathic Physicians Licensing Board was polled to determine any foreseeable costs associated with these proposed changes. Upon review, the Board members determined that there would be no fiscal impact.

Comments by the department head on the fiscal impact the rule may have on businesses:

I have reviewed the proposed filing for the above-referenced rule and considered the fiscal impact that the rule may have on businesses. I direct that my comments about the rule's fiscal impact on businesses be inserted at the appropriate place on the notice form to be filed with the Office of Administrative Rules for publication of this rulemaking action. In Section R156-71-202, these proposed changes in this provision are nonsubstantive as they incorporate a reference to a Council on Naturopathic Medical Education residency program in place of a less clear description of the required residency program. In Subsection R156-71-202(1), these proposed changes update the naturopathic physician formulary. The reference for the formulary is the 2008 edition of the American Hospital Formulary Service (AHFS). This change allows practitioners to use the 2008 edition or to access the current edition on the AHFS Drug information website. The other changes to the subsection include updating the formulary to identify non-controlled legend medications that may be used by naturopathic physicians to provide improved patient care within the scope of practice. These proposed amendments apply only to persons required to be licensed as a naturopathic physician in Utah. There are currently 80 naturopathic physician licensees (NAICS 621399). It is estimated that most operate private or group practices in their own offices and that several operate in the facilities of others, such as hospitals or HMO medical centers. The Section R156-71-102 changes have no fiscal impact. The changes to Subsection R156-71-202(1) allow the use of the 2008 edition of the AHFS formulary or to access the formulary online. There may be a cost saving for those needing to consult the formulary, as they can avoid purchasing one and use the online version. There are no other fiscal impacts.

Francine A. Giani, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Commerce
Occupational and Professional Licensing
HEBER M WELLS BLDG
160 E 300 S
SALT LAKE CITY, UT 84111-2316

Direct questions regarding this rule to:

  • Larry Marx at the above address, by phone at 801-530-6254, by FAX at 801-530-6511, or by Internet E-mail at lmarx@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

05/31/2018

Interested persons may attend a public hearing regarding this rule:

  • 05/24/2018 02:00 PM, Heber Wells Bldg, 160 E 300 S, Conference Room 475 (fourth floor), Salt Lake City, UT

This rule may become effective on:

06/07/2018

Authorized by:

Mark Steinagel, Director

RULE TEXT

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs


FY 2018


FY 2019


FY 2020


State Government


$0


$0


$0


Local Government


$0


$0


$0


Small Businesses


$0


$0


$0


Non-Small Businesses


$0


$0


$0


Other Person


$0


$0


$0


Total Fiscal Costs:


$0


$0


$0






Fiscal Benefits





State Government


$0


$0


$0


Local Government


$0


$0


$0


Small Businesses


$0


$0


$0


Non-Small Businesses


$0


$0


$0


Other Persons


$0


$0


$0


Total Fiscal Benefits:


$0


$0


$0






Net Fiscal Benefits:


$0


$0


$0


 

*This table only includes fiscal impacts that could be measured. If there are inestimable fiscal impacts, they will not be included in this table. Inestimable impacts for State Government, Local Government, Small Businesses and Other Persons are described above. Inestimable impacts for Non - Small Businesses are described below.

 

Appendix 2: Regulatory Impact to Non - Small Businesses:

These proposed rule changes are not expected to impact non-small businesses. Again, any cost savings cannot be estimated as the necessary data are unavailable, and the Naturopathic Physicians Licensing has determined that there will be no fiscal cost.

 

The head of the Department of Commerce, Francine A. Giani, has reviewed and approved this fiscal analysis.

 

 

R156. Commerce, Occupational and Professional Licensing.

R156-71. Naturopathic Physician Practice Act Rule.

R156-71-102. Definitions.

In addition to the definitions in Title 58, Chapters 1 and 71, as used in Title 58, Chapters 1 and 71, or this rule:

(1) "Approved clinical experience program" or "residency program" as used in Subsections 58-71-302(1)(e) and 58-71-304.2(1)(b), means a Council of Naturopathic Medical Education (CNME) approved residency program (i.e. a residency program under the auspices of a CNME-accredietd or CNME candidate Naturopathic Doctorate (ND) program that is recognized by the CNME as a residency program sponsor), that is at a minimum one year in length[minimum 12 month program associated with a naturopathic medical school or college accredited by the Council of Naturopathic Medical Education].

(2) "Direct supervision" as used in Subsection 58-71-304.2(1)(b), means the supervising naturopathic physician, physician and surgeon, or osteopathic physician is responsible for the naturopathic activities and services performed by the naturopathic physician intern and is normally present in the facility and when not present in the facility is available by voice communication to direct and control the naturopathic activities and services performed by the naturopathic physician intern.

(3) "Direct and immediate supervision" of a medical naturopathic assistant ("assistant") as used in Subsections 58-71-102(6) and 58-71-305(7), means that the licensed naturopathic physician is responsible for the activities and services performed by the assistant and will be in the facility and immediately available for advice, direction and consultation.

(4) "Distance learning" means the acquisition of knowledge and skills through information and instruction encompassing all technologies and other forms of learning at a distance, including internet, audio/visual recordings, mail or other correspondence.

(5) "Naturopathic physician intern" or "intern" means an individual who qualifies for a temporary license under Section 58-71-304.2 to engage in a naturopathic physician residency program recognized by the division under the direct supervision of an approved naturopathic physician, physician and surgeon, or osteopathic physician.

(6) "NPLEX" means the Naturopathic Physicians Licensing Examinations.

(7) "Primary health care", as referenced in Subsection 58-71-102(12), means basic or general health care provided at the patient's first contact with the naturopathic physician.

(8) "Qualified continuing education," as used in this rule, means continuing education that meets the standards set forth in Subsection R156-71-304.

(9) "Unprofessional conduct," as defined in Title 58, Chapters 1 and 71, is further defined, in accordance with Subsection 58-1-203(5), in Section R156-71-502.

 

R156-71-202. Naturopathic Physician Formulary.

(1) In accordance with Subsections 58-71-102(8) and (12)(a) and Section 58-71-202, the naturopathic physician formulary which consists of noncontrolled substance legend medications deemed appropriate for the primary health care of patients within the scope of practice of naturopathic physicians, the prescription of which is approved by the Division in collaboration with the Naturopathic Formulary Advisory Peer Committee, consists of the following legend drugs, listed by category, with reference numbers identified in the American Hospital Formulary Service (AHFS), published by the American Society of Health System Pharmacists, 2008 edition or the current edition[; including the monographs] available on AHFS Drug Information website, which is http://www.ahfsdruginformation.com:

4:00 Antihistamines

8:08 Antihelminthics

8:12 Antibacterials, limited to oral, topical and intramuscular administration

8:14 Antifungals, oral and topical forms

8:16.92 Miscellaneous Antimycobacterials

8:18 Antivirals limited to oral and topical dosage forms, excluding:

8:18:08 Antiretrovirals

8:18:20 Interferons

8:18:24 Monoclonal Antibodies

8:18:32 Nucleosides and Nucleotides

8:30.04 Amebicides

8:30.92 Miscellaneous Antiprotozoals excluding those whose primary indication is the treatment of infection in immunosuppressed patients (i.e. Pentamidine and Trimetrexate)

8:36 Urinary anti-infectives

12:12.08.12 Selective Beta 2 Adrenergic Agonists

12:12.12 Alpha and Beta Adrenergic Agonists

12:16 Sympatholytic (Adrenergic Blocking) Agents, limited to ergot derivatives

12:20 Skeletal Muscle Relaxants, excluding scheduled medications

20:12.04.16 Heparins

20:24 Hemorrheologic Agents

24:04.08 Cardiotonic Agents - limited to Digoxin

24:06 Antilipemic Agents

24:08 Hypotensive Agents - limited to oral dosage forms

24:20 Alpha Adrenergic Blocking Agents

24:24 Beta Adrenergic Blocking Agents - limited to oral dosage forms

24:28 Calcium Channel Blocking Agents - limited to oral dosage forms

24:32 Renin-Angiotensive-Aldosterone System Inhibitors - limited to oral dosage forms

28:08 Analgesics and Antipyretics, excluding scheduled medications

28:10 Opiate Antagonists

28:16.04.16 Selective Serotonin - and Norepinephrine-Reuptake Inhibitors

28:16.04.20 Selective-Serotonin Reuptake Inhibitors

28:16.04.24 Serotonin Modulators

28:16.04.28 Tricyclics and Other Norepinephrine-Reuptake Inhibitors

28:16.04.92 Antidepressants, Miscellaneous

28:32.28 Selective Serotonin Agonists

40:00 Electrolytic, Caloric, and Water Balance

40:18.92 Other Ion-removing Agents

40:28 Diuretics

44:00 Enzymes, limited to digestive and proteolytic

48:10.24 Leukotriene Modifiers

48:10.32 Mast-Cell Stabilizers

48:16 Expectorants

52:08 Corticosteroids (oral, topical, and injectable), Anti-Inflammatory Agents and DMARDS

52:24 Mydriatics

56:22 Antiemetics

56:28 H2 Blockers, Anti-ulcer Agents and Acid Suppressants

56:36 Anti-inflammatory Agents

64:00 Heavy Metal Antagonists, [limited to Dimercaprol, Edetate Calcium Disodium and Succimer]in addition to DMPS (2,3-Dimercapto-1-propanesulfonic acid)

68:12 Contraceptives, except implants and injections

68:16.04 Estrogens

68:16.08 Antiestrogens, limited to Anastrozole for use in the setting of hormon replacement therapy

68:16.12 Estrogen Agonists-Antagonists, limited to Raloxifene

68:18 Gonadotropins; limited to Gonadotropin, Chorionic

68:20.02 Alpha-Glucosidase Inhibitors

68:20.04 Biguanides

68:20.08 Insulins

68:20.20 Sulfonylureas

68:24 Parathyroid

68:32 Progestins

68:36 Thyroid and Antithyroid Agents, including Thyroid of glandular extract

72:00 Local Anesthetics

76:00 Oxytocics, limited to Oxytocin

80:00 Serums, Toxoids, Vaccines

84:00 Skin and Mucous Membrane Agents, excluding Depigmenting and Pigmenting Agents (reference number 84:50)

84:92 Skin and Mucous Membrane Agents, Miscellaneous, excluding Isotretinoin

88:00 Vitamins

92:00 Miscellaneous Therapeutic Agents, limited to [Antigout, and Bone-Resorption Inhibitors (limited to Raloxifene), and ]Botulinum Toxin type A (limited to superficial injections)

92:08 5-Alpha-Reductase Inhibitors

92:16 Antigout Agents

(2) In addition, the following items or substances, although not listed in Subsection (1), are approved for primary health care:

(a) Amino Acids;

(b) Minerals;

(c) Oxygen;

(d) Silver Nitrate;

(e) DHEA (dihydroepiandrosterone);

(f) Pregnenolone; and

(g) Allergy Testing Agents.

(3) In accordance with Subsections 58-71-102(8) and (12)(a) and Section 58-71-202, the naturopathic physician formulary includes a single controlled substance with the reference number identified in the AHFS, published by the American Society of Health System Pharmacists, 2008 edition:

68:08 Testosterone.

(4) New categories or classes of drugs will need to be approved as part of the formulary prior to prescribing/administering.

(5) The licensed naturopathic physician has the responsibility to be knowledgeable about the medication being prescribed or administered.

 

R156-71-302. Qualifications for Licensure - Examination Requirements.

In accordance with Subsections 58-71-302(1)(f) and (2)(c), the licensing examination sequence required for licensure is as follows:

(1) NPLEX Basic Science Series, the State of Washington Basic Science Series or the State of Oregon Basic Science Series;

(2) NPLEX Clinical Series; and

(3) NPLEX Minor Surgery.

 

R156-71-302a. Qualifications for Licensure - Education Requirements for Graduates of Naturopathic Physician Programs or Schools Located Outside the United States.

The satisfactory documentation of compliance with the licensure requirement set forth in Subsection 58-71-302(2)(b) shall be a report submitted to the Division by the International Credentialing Associates, Inc. (ICA) confirming that the applicant's naturopathic physician program or school has met the accreditation standards.

 

R156-71-303. Renewal Cycle - Procedures.

(1) In accordance with Subsection 58-1-308(1), the renewal date for the two year renewal cycle applicable to licensees under Title 58, Chapter 71 is established by rule in Section R156-1-308a(1).

(2) Renewal procedures shall be in accordance with Section R156-1-308c.

 

R156-71-304. Qualified Continuing Education.

(1) To be qualified continuing education, a continuing education course shall meet the following standards:

(a) the course shall consist of clinically oriented seminars, lectures, conferences, workshops, mediated instruction, or programmed learning provided by one of the following:

(i) a professional health care licensing agency, hospital, or institution accredited by the Accreditation Council of Continuing Medical Education (ACCME);

(ii) a program sponsored by the American Council of Pharmaceutical Education (ACPE);

(iii) an accredited college or university;

(iv) a professional association or organization representing a licensed profession whose program objectives are related to naturopathic training; or

(v) any other provider providing a program related to naturopathic education, if the provider has submitted an application to and received approval from the Utah Naturopathic Physicians Licensing Board;

(b) the learning objectives of the course shall be reasonably and clearly stated;

(c) the teaching methods shall be clearly stated and appropriate;

(d) the faculty shall be qualified both in experience and in teaching expertise;

(e) there shall be a written post course or program evaluation;

(f) the documentation of attendance shall be provided; and

(g) the content of the course shall be relevant to naturopathic practice and consistent with the laws and rules of this state.

(2) In accordance with Section 58-71-304, qualified continuing education shall consist of 48 hours of qualified continuing professional education in each preceding two year period of licensure, 20 hours of which shall be specific to pharmacy or pharmacology as it pertains to the Naturopathic Physician Formulary, Section R156-71-202. A minimum of ten of the 20 hours of continuing education specific to pharmacy or pharmacology must be recognized as category 1 credit hours as established by the ACCME in each preceding two year licensure cycle. No more than 20 hours of continuing education in each two-year period of licensure may be through distance learning.

(3) If a licensee allows his license to expire and the application for reinstatement is received by the division within two years after the expiration date the applicant shall:

(a) submit documentation of having completed 48 hours of qualified continuing professional education required for the previous renewal period. The required hours shall meet the criteria set forth in Subsection (2); and

(b) submit documentation of having completed a pro rata amount of qualified continuing professional education based upon one hour of qualified continuing professional education for each month the license was expired for the current renewal period.

(4) If the application for reinstatement is received by the division more than two years after the date the license expired, the applicant shall complete a minimum of 48 hours of qualified continuing professional education and additional hours as determined by the board to clearly demonstrate the applicant is currently competent to engage in naturopathic medicine. The required hours shall meet the criteria set forth in Subsection (2).

(5) Audits of a licensee's continuing education hours may be done on a random basis by the division in collaboration with the board.

(6) A licensee shall be responsible for maintaining competent records of completed qualified professional education for a period of two years after close of the two year period to which the records pertain. It is the responsibility of the licensee to maintain this information with respect to qualified professional education to demonstrate it meets the requirements under this section.

(7) The division in collaboration with the board may grant a waiver of continuing education requirements to a waiver applicant who documents he is engaged in full time activities or is subjected to circumstances which prevent the licensee from meeting the continuing professional education requirements established under this section. A waiver may be granted for a period of up to four years. However, it is the responsibility of the licensee to document the reasons and justify why the requirement could not be met.

 

R156-71-502. Unprofessional Conduct.

"Unprofessional conduct" includes failure to comply with the approved formulary.

 

KEY: licensing, naturopaths, naturopathic physician

Date of Enactment or Last Substantive Amendment: [April 21, 2015]2018

Notice of Continuation: August 25, 2016

Authorizing, and Implemented or Interpreted Law: 58-71-101; 58-1-106(1)(a); 58-1-202(1)(a)


Additional Information

More information about a Notice of Proposed Rule is available online.

The Portable Document Format (PDF) version of the Bulletin is the official version. The PDF version of this issue is available at https://rules.utah.gov/publicat/bull_pdf/2018/b20180501.pdf. The HTML edition of the Bulletin is a convenience copy. Any discrepancy between the PDF version and HTML version is resolved in favor of the PDF version.

Text to be deleted is struck through and surrounded by brackets ([example]). Text to be added is underlined (example).  Older browsers may not depict some or any of these attributes on the screen or when the document is printed.

For questions regarding the content or application of this rule, please contact Larry Marx at the above address, by phone at 801-530-6254, by FAX at 801-530-6511, or by Internet E-mail at lmarx@utah.gov.  For questions about the rulemaking process, please contact the Office of Administrative Rules.