No. 30854 (Amendment): R156-71. Naturopathic Physician Practice Act Rules

DAR File No.: 30854
Filed: 12/18/2007, 08:53
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

The division and the Naturopathic Physicians Licensing Board are proposing amendments to the rule to recodify and expand the naturopathic formulary using the American Hospital Formulary Service as a medical reference for prescription medications used by naturopathic physicians. The Naturopathic Physician Licensing Examination (NPLEX) has changed the format for its national examination, so the rule should be modified to reflect the updated examinations. The number of required continuing education hours will be increased and additional continuing education requirements added.

Summary of the rule or change:

Throughout the rule the term "rules" has been replaced with "rule" where applicable. In Section R156-71-102, new definitions for "distance learning" and "primary health care" have been added. The definition for "primary health care" is based on the definition of "primary care" from Taber's Cyclopedic Medical Dictionary, 15th edition, published by F.A. Davis. In Section R156-71-202, the proposed amendments recodify the naturopathic formulary. The old formulary listed legend drugs that were being used locally by naturopaths at the time. The Naturopathic Formulary Peer Committee researched and developed the new proposed formulary amendments. The amended formulary is based on primary health care and uses the reference numbers identified in the American Hospital Formulary Service (AHFS) published by the American Society of Health System Pharmacists, 2006 edition. This will become the standard reference for all legend drugs prescribed by naturopathic physicians. The Utah Medical Association (UMA) reviewed the proposed formulary modifications and indicated it has no concerns with naturopathic physicians prescribing medications from the proposed formulary. In Section R156-71-302, the Council of Naturopathic Medical Education has changed its examination format and has combined parts of the qualifying examinations. The NPLEX has combined the homeopathic portion with the Clinical Series examination, thus eliminating the requirement for the homeopathic examination. In Section R156-71-304, the proposed amendments increase the required number of continuing education hours in a 2-year period from 24 hours to 48 hours. The proposed amendments will require all licensed naturopathic physicians to attend at least 20 hours of pharmacology or pharmacy training in each 2-year period. The proposed amendments also limit distance learning to a maximum of 20 hours during each 2-year period. It is the Naturopathic Formulary Peer Committee's belief that the increase in required continuing education hours, required pharmacology training and the new legend drug references will ultimately create substantial improvements in public safety. As a result of proposed amendments with respect to continuing education, several new organizations may sponsor continuing education for naturopathic physicians. These include a professional health care licensing agency, hospital or institution accredited by the Accreditation Council of Continuing Medical Education (ACCME), the American Council on Pharmaceutical Education (ACPE), any accredited college or university, or any professional association or organization representing a licensed profession whose program objectives are related to naturopathic practice. The Utah Naturopathic Physicians Licensing Board may also approve continuing education courses if the course meets the required standards.

State statutory or constitutional authorization for this rule:

Section 58-71-101 and Subsections 58-1-106(1)(a) and 58-1-202(1)(a)

Anticipated cost or savings to:

the state budget:

The division will incur minimal costs of approximately $100 to reprint the rule once the proposed amendments are made effective. Any costs incurred will be absorbed in the division's current budget. The division's investigators will not require any additional training as a result of the proposed amendments. A possible increase in compliance costs to the Division may occur if complaints regarding the prescribing practices of naturopathic physicians are reported to the Division. Any potential cost increase is impossible to determine at this time. There are fewer than 30 licensed naturopathic physicians in Utah so any potential fiscal impact to the division would be minimal.

local governments:

The proposed amendments do not apply to local governments. The proposed amendments only apply to licensed naturopathic physicians and applicants for licensure as a naturopathic physician.

small businesses and persons other than businesses:

The proposed amendments to the naturopathic physician formulary will create a possible savings for the public and insurance carriers. Patients who presently see a naturopathic physician requesting specific types of medications may not be able to receive the required prescription. The patient currently has to schedule another visit with a prescribing practitioner. Each office visit to a prescribing practitioner is about $100 for each patient. If the naturopathic physician can prescribe the medication needed at the initial office visit, the result would be a reduction in duplication of services, thus reducing costs for the patients and insurance carriers. There is no way for the division to determine how many patients are seen by naturopathic physicians versus other types of prescribing practitioners. As a result of increasing the number of required continuing education hours for licensed naturopathic physicians from 24 hours to 48 hours with a mandatory 20 hours component every 2 years, licensed naturopathic physicians will see an increase in costs to obtain the required additional continuing education hours. The Utah Association of Naturopathic Physicians has reported that current continuing education costs are estimated at $25 per hour. The increase in cost for each licensed naturopathic physician could be approximately $600 for each 2-year period. There are approximately 30 licensed naturopathic physicians in Utah for an aggregate increase cost of $18,000 for each 2-year period. However, the increase in continuing education hours, required pharmacology training and the new formulary legend drug references are expected to create substantial improvements in public safety and potentially a reduction in malpractice insurance premiums for licensees. It should be noted that a licensed naturopathic physician office may qualify as a small business if such a naturopathic physician owns or works in a small clinic.

Compliance costs for affected persons:

The proposed amendments to the naturopathic physician formulary will create a possible savings for the public and insurance carriers. Patients who presently see a naturopathic physician requesting specific types of medications may not be able to receive the required prescription. The patient currently has to schedule another visit with a prescribing practitioner. Each office visit to a prescribing practitioner is about $100 for each patient. If the naturopathic physician can prescribe the medication needed at the initial office visit, the result would be a reduction in duplication of services, thus reducing costs for the patients and insurance carriers. There is no way for the division to determine how many patients are seen by naturopathic physicians versus other types of prescribing practitioners. As a result of increasing the number of required continuing education hours for licensed naturopathic physicians from 24 hours to 48 hours with a mandatory 20 hours component every 2 years, licensed naturopathic physicians will see an increase in costs to obtain the required additional continuing education hours. The Utah Association of Naturopathic Physicians has reported that current continuing education costs are estimated at $25 per hour. The increase in cost for each licensed naturopathic physician could be approximately $600 for each 2-year period. However, the increase in continuing education hours, required pharmacology training and the new formulary legend drug references are expected to create substantial improvements in public safety and potentially a reduction in malpractice insurance premiums for licensees.

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

This rule filing amends the naturopathic formulary, which is expected to be a cost savings to patients and presumably also a benefit to licensees, who will no longer need to refer their clients to medical doctors. Although the increased continuing education requirement will cost licensees approximately $600 each 2-year licensing period, public safety is expected to improve while malpractice insurance premiums are expected to decrease. It is thus difficult to estimate the actual costs to licensees. No other fiscal impact to businesses is anticipated. Francine A. Giani, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division 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:

Daniel T. Jones at the above address, by phone at 801-530-6767, by FAX at 801-530-6511, or by Internet E-mail at [e-mail]

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:

02/14/2008

Interested persons may attend a public hearing regarding this rule:

1/17/2008 at 9:00 AM, Heber Wells Bldg, 160 E 300 S, Conference Room 210 (second floor), Salt Lake CIty, UT

This rule may become effective on:

02/21/2008

Authorized by:

F. David Stanley, Director

RULE TEXT

R156. Commerce, Occupational and Professional Licensing.

R156-71. Naturopathic Physician Practice Act Rule[s].

R156-71-101. Title.

Th[ese]is rule[s are] is known as the "Naturopathic Physician Practice Act Rule[s]."

 

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 th[ese]is rule[s]:

(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 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.

([4]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.

([5]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.

([6]8) "Qualified continuing education," as used in th[ese]is rule[s], means continuing education that meets the standards set forth in Subsection R156-71-304.

([7]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.

 

R156-71-103. Authority - Purpose.

Th[ese]is rule[s are] is adopted by the division under the authority of Subsection 58-1-106(1)(a) to enable the division to administer Title 58, Chapter 71.

 

R156-71-202. Naturopathic Physician Formulary.

(1) In accordance with Subsections 58-71-102(8), 58-71-102(12)(a) and 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, 2006 edition:

[Adrenergic Stimulators, limited to: Albuterol, Epinephrine, and Metaproteranol;

Ace Inhibitors;

Amino Acids;

Anesthetics (local);

Antiemetics;

Antifungals, limited to: Nystatin and Fluconazole;

Antigout;

Antihistamines;

Anti-inflammatories, except DMARDS;

Antimicrobials (oral), limited to: Pencillins, 1st and 2nd generation Cephalosporins, Tetracyclines, Macrolides, Azalides, Lincosamines, Metronidazole, Hydantoins, and Sulfas;

Antimicrobials (ophthamologic), limited to: Sulfas and Macrolides;

Antimicrobials (topical);

Antivirals, limited to Acyclovir;

Biologics, limited to: Skin Testing, CDC recommended Immunizations, Toxoids, and Immunoglobulin;

Calcium Channel Blockers (2nd Generation Dihydropyridine);

Contraceptives, except implants and injections;

Corticosteroids (oral or topical), except Opthamologic Preparations;

Diabetic Agents, limited to: Insulin, and oral Hypoglycemics, except Thiazolidinediones;

Diuretics, limited to: Thiazide or Loop;

Dyslipidemia Modulators;

Electrolyte and Fluid Replacements;

Enzymes, limited to: Digestive and Proteolytic;

H2 Blockers;

Hormones;

Leukotrine modulators;

Migraine Preparations, limited to: Ergotamines and Sumatriptin;

Minerals: Macro and Micro;

Osteoporosis agents, limited to: Calcitonin and Raloxifene;

Oxygen;

Pentoxiflylline;

Proton-Pump Inhibitors;

Urinary Antispasmodics;

Vitamins;

Other: Methergine and Pitocin, limited to use only after the uterus has been emptied;

Silver Nitrate.]4:00 Antihistamines

8:08 Antihelminthics

8:12 Antibacterials

8:14 Antifungals

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

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 Antipyrectics, excluding scheduled medications

28:16.04.20 Selective-Serotonin Reuptake Inhibitors

28:16.04.24 Serotonin Modulators

28:16.04.28 Tricyclics and Other Norepinephrine-Reuptake Inhibitors

40:00 Electrolytic, caloric, and water balance

40:28 Diuretics

44:00 Enzymes, limited to digestive and proteolytic

52:08 Corticosteroids (oral or topical), Anti-Inflammatory Agents except Ophthmologic Preparations, and DMARDS

52:16 Local Anesthetics

56:22 Antiemetics

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

68:12 Contraceptives, except implants and injections

68:16.04 Estrogen

68:20.02 Alpha-Glucosidase Inhibitors

68:20.08 Insulins and Biguanides

68:20.20 Sulfonylureas

68:24 Parathyroid

68:32 Progestin

68:36.04 Thyroid agents, including thyroid of glandular extract

88:28 Multivitamin preparations

92:00 Antigout, and Bone-Resorption Inhibitors, limited to Raloxifene

(2) In addition, amino acids, minerals, oxygen and silver nitrate, although not listed in Subsection (1), are approved for primary health care.

([2]3) [New categories or classes of drugs will need to be approved as part of the formulary prior to prescribing/administering.]A naturopathic physician shall not prescribe or administer any medications not listed in Subsections (1) and (2), unless the naturopathic physician first submits a request for approval to the Division and the Naturopathic Formulary Peer Committee and obtains such approval.

([3]4) 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 58-71-302(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 Homeopathy; and

(4) ]NPLEX Minor Surgery.

 

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.

([1]2) In accordance with S[ubs]ection 58-71-304[(1)(a)], qualified continuing education shall consist of [24]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. No more than 20 hours of continuing education in each two-year period of licensure may be through distance learning.

([2]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 [24]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.

([3]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 [24]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).

[ (4) The standards for qualified continuing education are as follows:

(a) content must be relevant to naturopathic practice and consistent with the laws and rules of this state;

(b) under sponsorship of:

(i) an approved college or university; or

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

(c) learning objectives must be reasonably and clearly stated;

(d) teaching methods must be clearly stated and appropriate;

(e) faculty must be qualified, both in experience and in teaching expertise;

(f) there must be a written post course or program evaluation; and

(g) documentation of attendance must be provided.

(5) Qualified continuing education shall consist of at least 10 hours of seminars, conferences or workshops addressing case management and prescribing of legend drugs.

] ([6]5) Audits of a licensee's continuing education hours may be done on a random basis by the division in collaboration with the board.

([7]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.

([8]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.

 

KEY: licensing, naturopaths, naturopathic physician

Date of Enactment or Last Substantive Amendment: [October 26, 2006]2008

Notice of Continuation: January 8, 2007

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