Section 1155-04-.20 - PHARMACISTS, HOME MEDICAL EQUIPMENT PROVIDERS, AND ORTHOSIS MANUFACTURERS(1) Nothing in these rules shall be interpreted as limiting or restricting individuals acting under the supervision and control of a pharmacist or pharmacy licensed under Title 63, or home medical equipment provider licensed under Title 68, from measuring, fitting or adjusting any non-custom fabricated and fitted device, including but not limited to over-the-counter devices or off-the-shelf devices, so long as such individual does not create a cast, mold or scan of a part of the human body for the purpose of constructing a medical device to treat a patient's medical condition and so long as such individual meets one of the following criteria for such device:(a) Documented training from a manufacturer; or training from a licensed or certified orthotist, prosthetist, or pedorthist; or(b) Certification or registration as a fitter of orthotics, prosthetics, or pedorthics, from a nationally recognized board or association such as the Board for Orthotist/Prosthetist Certification (BOC), the Board of Certification for Pedorthists, the National Community Pharmacists Association (NCPA), or the American Board for Certification in Orthotics and Prosthetics (ABC); or(c) Direct supervision by a trained and experienced, or certified, or registered, fitter of orthotic, prosthetic, or pedorthic devices.(2) Nothing in these rules shall be interpreted as limiting or restricting individuals acting under the supervision and control of a pharmacist or pharmacy licensed under Title 63, or home medical equipment provider licensed under Title 68, from measuring, fitting or adjusting any non-custom fabricated and fitted pedorthic devices, including but not limited to diabetic shoes, provided such individual meets the criteria of either subparagraph (1) (b) or (1) (c) and so long as the individual does not create a cast, mold or scan of a part of the human body for the purpose of constructing a medical device to treat a patient's medical problem.(3) Nothing in these rules shall be interpreted as limiting or restricting the measuring, fitting or adjusting of an orthotic device by an employee or authorized representative of an orthosis manufacturer registered with the federal Food and Drug Administration, provided:(a) Such employee or representative is supervised by a licensed health care professional authorized by law to prescribe, measure or fit such device, and who examines the patient to ensure that the device has been properly measured, fitted or adjusted by the employee or representative; and(b) The measuring, fitting or adjusting of such device occurs in the office of such licensed health care professional or in a health care facility.Tenn. Comp. R. & Regs. 1155-04-.20
Original rule filed July 13, 2006; effective September 26, 2006.Authority: T.C.A. §§ 4-5-202, 4-5-204, 63-3-106, 63-3-202, 63-3-203, and 63-3-205.