Board of Naturopathic Medicine — Formulary and Scope of Practice (meeting minutes)
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Minutes documenting actions, decisions, and agenda items of the Hawaii Board of Naturopathic Medicine meeting on August 9, 2013; affects board members, naturopathic physicians, and stakeholders involved in the Naturopathic Formulary and related rule definitions.
No material clinical or coverage changes in this revision.
Formulary and Scope of Practice Determinations
Formulary and scope of practice criteria
Board determinations and formulary actions recorded during the meeting:
Board referenced HAR sections 16-88-80(a)(5)(A),(F) and 16-88-80(a)(6)(B)
Physician bears burden to show appropriate education/training to use drug for indications beyond category use (e.g., cancer)
At prior meetings the Board addressed whether injectable dermatological agents were part of the Naturopathic Formulary. At the May 13, 2011 meeting the Board indicated that agents such as Juvederm and botox were not included on the formulary, but subsequently the Board amended the formulary (November 30, 2012) to include all biological substances for use in therapeutic injection techniques. The Board specifically determined that botox, hyaluronic acid, and Juvederm meet the definition of biological substances under the Naturopathic Formulary categories referenced in the minutes.
Following that amendment, the Board considered whether the use of these biological substances for cosmetic treatment is consistent with naturopathic practice. After review of HAR section 16-88-80, the Board reached a consensus that cosmetic treatments are consistent with naturopathic medicine when provided by a naturopathic physician with appropriate advanced education and training, because such treatments can support a patient’s health and sense of well‑being. The minutes record that the Board placed the burden on the individual naturopathic physician to demonstrate the necessary advanced education and training before providing injectable cosmetic dermatological agents.
Permissions, Responsibilities, and Course Approval
Authorization to perform cosmetic and off‑label treatments
Any naturopathic physician may provide cosmetic treatment using injectable cosmetic dermatological agents only if they possess appropriate advanced education and training; when using formulary drugs for off‑label indications, the physician bears the burden to demonstrate appropriate education and training for that use.
Formulary use responsibilities for phenylbutyrate
When phenylbutyrate is added to the Naturopathic Formulary, the naturopathic physician is responsible for determining appropriate use and must demonstrate appropriate advanced education and training to prescribe or use the drug for indications beyond its formulary category (e.g., cancer).
- Board moved to add phenylbutyrate to the Naturopathic Formulary under Renal and Genitourinary Agents.
- DAG stated the burden is on the naturopathic physician to show appropriate advanced education and training to use a drug for a specific condition beyond category use.
Qualifying course documentation requirements
Course administrators must provide the instructor's curriculum vitae demonstrating compliance with HAR section 16-88-57(d)(1) and submit an attestation that the course is the same as one previously approved by the Board when requesting approval of qualifying parenteral therapy courses.
- Submit CVs showing instructor meets HAR 16-88-57(d)(1) qualifications (e.g., required teaching experience/accreditation criteria).
- Submit an attestation that the submitted course matches a course previously approved by the Board.
Course approval denial risk — instructor credential deficiencies
Course approval may be deferred if submitted instructor credentials do not demonstrate the HAR section 16-88-57(d)(1) requirements; the course administrator must then provide additional documentation and an attestation for the deferred course.
- Board deferred approval of a qualifying parenteral therapy course because Dr. Pomroy’s CV failed to show the required teaching experience under HAR 16-88-57(d)(1).
- Deferred courses require the administrator to provide documentation that the instructor meets HAR 16-88-57(d)(1) and submit an attestation the course is previously approved.
Clinical Background and Drug Information
Phenylbutyrate was discussed for addition to the Naturopathic Formulary under the class Renal and Genitourinary Agents. The Board moved to add phenylbutyrate to the formulary, noting its established use in treating urea cycle disorders and other renal/genitourinary indications recorded in the formulary section.
The minutes record that phenylbutyrate may be used by naturopathic physicians consistent with formulary placement, but also emphasize that when a drug is used for indications beyond its typical category uses (for example, off‑label oncology use), the prescribing physician bears the responsibility to show they have the requisite advanced education and training to do so. The clinical background noted in the materials also indicates phenylbutyrate can be administered orally or intravenously and has known adverse reactions including nausea, vomiting, and fatigue; dosing and safety considerations should follow established clinical references and product labeling.
Key Definitions from DOH Draft TB Chapter
Next Steps and Meeting Dates
Board of Naturopathic Medicine met and documented actions including adding phenylbutyrate to the Naturopathic Formulary and classifying certain injectable dermatological agents as biological substances; meeting minutes recorded August 9, 2013.
Next Board meeting scheduled for November 8, 2013 at 2:00 p.m. in the King Kalakaua Conference Room.
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