DAR File No. 32675

Commerce, Occupational and Professional Licensing

R156-71

Naturopathic Physician Practice Act Rule

NOTICE OF PROPOSED RULE

DAR File No.: 32675
Filed: 05/18/2009, 09:33
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

The Division, Naturopathic Formulary Advisory Peer Committee, and the Naturopathic Physicians Licensing Board reviewed the rule and determined that amendments need to be made. This rule filing includes several noncontrolled substances that need to be added to the formulary and adds testosterone, a controlled substance, to the formulary in accordance with the change in the Naturopathic Physician Practice Act, Title 58, Chapter 71, made during the 2009 Legislative Session in H.B. 108. An amendment is also filed with respect to continuing education qualifications. (DAR NOTE: H.B. 108 (2009) is found at Chapter 42, Laws of Utah 2009, and was effective 05/12/2009.)

Summary of the rule or change:

In Section R156-71-202, the naturopathic formulary medications have been based on providing primary health care using the reference numbers identified in the American Hospital Formulary Service (AHFS), published by the American Society of Health System Pharmacists, 2006 edition. The AHFS is being updated to now reference the 2008 edition. Several new noncontrolled substance medications are being added to the formulary: Leukotriene Modifiers, Serums, limited to RhoGam, Toxoids, limited to DTP, and DtaP. Also, one controlled substance, testosterone, is being added to the formulary as provided in H.B. 108. In Subsection R156-71-304(2), an amendment is added that indicates a minimum of 10 of the 20 hours of continuing education specific to pharmacy or pharmacology must be recognized as category 1 credit hours as established by the Accreditation Council of Continuing Medical Education (ACCME) in each preceding 2-year licensure cycle.

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 print the rule and distribute it once the proposed amendments are made effective. Any costs incurred will be absorbed in the Division's current budget. The Division investigators should not require any additional training as a result of the proposed amendments. A possible increase in costs to the Division may occur if complaints regarding the prescribing practices of naturopathic physicians are reported to the Division. However, 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 only apply to licensed naturopathic physicians and applicants for licensure in that classification. As a result, no costs or savings are anticipated for local governments.

small businesses and persons other than businesses:

It should be noted that a licensed naturopathic physician's office may qualify as a small business if the naturopathic physician owns or works in a small clinic. The proposed amendments will create a possible savings for the public and insurance carriers resulting in possible loss to secondary prescribing practitioners. Patients currently must schedule additional visits with a secondary prescribing practitioner at a cost of approximately $100 per patient. The addition of several noncontrolled substance medications indicated above and a controlled substance, testosterone, to the permitted medications also allows patients seen by a naturopathic physician to receive treatment from them instead of requiring the patient to schedule another office visit with another type of prescribing practitioner resulting in a similar cost savings. The Division is unable to determine the number of patients seen by naturopathic physicians. Also, if a licensed naturopathic physician wishes to prescribe the controlled substance testosterone, a $90 controlled substance application fee will be required and a renewal fee of $68 will be due every 2 years.

Compliance costs for affected persons:

The proposed amendments will create a possible savings for the public and insurance carriers resulting in possible loss to secondary prescribing practitioners. Patients currently must schedule additional visits with a secondary prescribing practitioner at a cost of approximately $100 per patient. The addition of several noncontrolled substance medications indicated above and a controlled substance, testosterone, to the permitted medications also allows patients seen by a naturopathic physician to receive treatment from them instead of requiring the patient to schedule another office visit with another type of prescribing practitioner resulting in a similar cost savings. Also, if a licensed naturopathic physician wishes to prescribe the controlled substance testosterone, a $90 controlled substance application fee will be required and a renewal fee of $68 will be due every 2 years.

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

This rule filing amends the naturopathic formulary to include "testosterone" which is now required by statute; the filing includes various substances that were inadvertently left out of a prior amendment to the formulary; updates references to the current edition of the American Society of Health System Pharmacists; and makes other technical corrections. No fiscal impact to businesses is anticipated beyond those addressed in the rule summary. 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:

Sally Stewart at the above address, by phone at 801-530-6179, by FAX at 801-530-6511, or by Internet E-mail at SStewart@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:

07/15/2009

Interested persons may attend a public hearing regarding this rule:

6/22/2009 at 9:00 AM, Heber Wells Bldg, 160 E 300 S, Conference Room 474 (fourth floor), Salt Lake City, UT

This rule may become effective on:

07/22/2009

Authorized by:

Thad LeVar, Deputy Director

R156. Commerce, Occupational and Professional Licensing.

R156-71. Naturopathic Physician Practice Act Rule.

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]2008 edition:

4:00 Antihistamines

8:08 Antihelminthics

8:12 Antibacterials, oral and topical forms only

8:14 Antifungals, oral and topical forms

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

20:24 Hemorrheologic Agents

24:04:08 Cardiotonic [a]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 Antipyre[c]tics, 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, [c]Caloric, and [w]Water [b]Balance

40:28 Diuretics

44:00 Enzymes, limited to digestive and proteolytic

48:10:24 Leukotriene Modifiers

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

52:16 Local Anesthetics]

56:22 Antiemetics

56:28 H2 Blockers, Anti-ulcer [a]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 [a]Agents, including [t]Thyroid of glandular extract

72:00 Local Anesthetics

80:00 Serums, limited to RhoGam

80:08 Toxoids, limited to DTP and DTaP

80:12 Vaccines

88:28 Multivitamin preparations

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

(2) In addition, [a]Amino [a]Acids, [m]Minerals, [o]Oxygen and [s]Silver [n]Nitrate, although not listed in Subsection (1), are approved for primary health care.

(3) In accordance with Subsections 58-71-102(8), 57-71-102(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.

([3]4) New categories or classes of drugs will need to be approved as part of the formulary prior to prescribing/administering.

([4]5) The licensed naturopathic physician has the responsibility to be knowledgeable about the medication being prescribed or administered.

 

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.

 

KEY: licensing, naturopaths, naturopathic physician

Date of Enactment or Last Substantive Amendment: [November 24, 2008]2009

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)