NAC639.69533. Customized orthotic or prosthetic devices: Approval by Board required.

     1. A medical products provider, or an applicant for a license to engage in business as a medical products provider, that wishes to sell, lease or otherwise provide a customized orthotic or prosthetic device to a consumer must be approved by the Board. The medical products provider or applicant must apply for approval in the manner prescribed by the Board.

     2. The Board will not give its approval unless the medical products provider or applicant submits evidence to the Board that the medical products provider or applicant:

     (a) Has employed, contracted with or otherwise retained the services of a person who is certified by an accreditation and certification organization; and

     (b) Except as otherwise provided in this subsection, possesses a facility at which to provide a customized orthotic or prosthetic device to a consumer:

          (1) That is accredited by an accreditation and certification organization; or

          (2) For which the medical products provider or applicant has applied to an accreditation and certification organization for accreditation.

Ê The provisions of paragraph (b) do not apply to a medical products provider or applicant if the only customized orthotic or prosthetic device to be provided by the medical products provider or applicant is a customized breast prosthesis or customized mastectomy form.

     3. If the Board gives its approval to a medical products provider or applicant whose facility is not accredited by an accreditation and certification organization, the medical products provider or applicant shall:

     (a) Pursue its application for accreditation of the facility in good faith; and

     (b) Unless excused by the Board, obtain accreditation of the facility within 12 months after the submission of its application to the accreditation and certification organization.

     4. The Board may withdraw its approval if the medical products provider:

     (a) Ceases to satisfy any condition set forth in this section for which the Board could have initially withheld its approval; or

     (b) Violates any provision of NAC 639.693 to 639.6958, inclusive.

     (Added to NAC by Bd. of Pharmacy by R033-07, eff. 8-26-2008)