410-122-0510 Osteogenesis Stimulator (1) Definitions: (a) An electrical osteogenesis stimulator is a device that provides electrical stimulation to augment bone repair; (b) A noninvasive electrical stimulator is characterized by an external power source that is attached to a coil or electrodes placed on the skin or on a cast or brace over a fracture or fusion site; (c) An ultrasonic osteogenesis stimulator is a noninvasive device that emits low intensity, pulsed ultrasound signals to stimulate fracture healing. The device is applied to the surface of the skin at the fracture site and ultrasound waves are emitted via conductive coupling gel to stimulate fracture healing; (2) Indications of coverage and medical appropriateness:(a) Non-spinal Electrical Osteogenesis Stimulator: (a) The Division may cover a non-spinal electrical osteogenesis stimulator (E0747) when any of the following criteria are met: (A) Non-union of a long bone fracture (defined as radiographic evidence that fracture healing has ceased for three or more months prior to starting treatment with the osteogenesis stimulator); or (B) Failed fusion of a joint other than in the spine where a minimum of nine months has elapsed since the last surgery; or (C) Congenital pseudarthrosis; (i) Non-union of a long bone fracture shall be documented by a minimum of two sets of radiographs obtained prior to starting treatment with the osteogenesis stimulator, separated by a minimum of 90 days, each including multiple views of the fracture site and with a written interpretation by the treating practitioner stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs; (ii) A long bone is limited to a clavicle, humerus, radius, ulna, femur, tibia, fibula, metacarpal or metatarsal. (b) Spinal Electrical Osteogenesis Stimulator: (A) The Division may cover a spinal electrical osteogenesis stimulator (E0748) when any of the following criteria are met: (i) Failed spinal fusion where a minimum of nine months has elapsed since the last surgery; or (ii) Following a multilevel spinal fusion surgery; or (iii) Following spinal fusion surgery where there is a history of a previously failed spinal fusion at the same site; (B) A multilevel spinal fusion involves three or more vertebrae (e.g., L3-L5, L4-S1, etc.); (c) Ultrasonic Osteogenesis Stimulator: (A) The Division may cover an ultrasonic osteogenesis stimulator (E0760) only when all of the following criteria are met: (i) Non-union of a fracture documented by a minimum of two sets of radiographs obtained prior to starting treatment with the osteogenic stimulator, each separated by a minimum of 90 days. Each radiograph shall include multiple views of the fracture site accompanied by a written interpretation by the treating practitioner stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs; and (ii) The stimulator is intended for use prior to surgical intervention and with cast immobilization; (B) Use of an ultrasonic osteogenic stimulator is not covered: (i) For non-union fractures of the skull or vertebrae; (ii) For tumor-related fractures; (iii) For the treatment of a fresh fracture or delayed union; or (iv) When used concurrently with other noninvasive osteogenic devices; (C) The Division may cover ultrasonic conductive coupling gel as a separate service when an ultrasonic osteogenesis stimulator is covered. (3) Coding guidelines: Use A4559 for ultrasonic conductive coupling gel. (4) Documentation requirements: (a) Submit the following with the PA request: (A) Documentation that supports the coverage criteria specified in this rule for the stimulator requested are met; (B) Copies of x-ray and operative reports; (b) Additional medical records may be requested by the Division; (c) The client’s medical records shall reflect the need for the stimulator requested. The client’s medical records include, but are not limited to, the practitioner’s office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals, and test/diagnostic reports. (5) Table 122-0510. [ED. NOTE: Tables referenced are available from the agency.] [ED. NOTE: To view attachments referenced in rule text, click here to view rule.] Statutory/Other Authority: ORS 413.042 & 414.065 Statutes/Other Implemented: ORS 414.065 History: DMAP 17-2024, minor correction filed 01/04/2024, effective 01/04/2024 DMAP 101-2023, amend filed 12/29/2023, effective 01/01/2024 DMAP 11-2016, f. 2-24-16, cert. ef. 3-1-16 OMAP 47-2006, f. 12-15-06, cert. ef. 1-1-07 OMAP 25-2006, f. 6-14-06, cert. ef. 7-1-06 OMAP 44-2004, f. & cert. ef. 7-1-04 OMAP 21-2003, f. 3-26-03, cert. ef. 4-1-03 OMAP 47-2002, f. & cert. ef. 10-1-02 OMAP 32-2001, f. 9-24-01, cert. ef. 10-1-01 OMAP 37-2000, f. 9-29-00, cert. ef. 10-1-00 OMAP 1-2000, f. 3-31-00, cert. ef. 4-1-00 OMAP 11-1998, f. & cert. ef. 4-1-98 HR 7-1997, f. 2-28-97, cert. ef. 3-1-97 HR 17-1996, f. & cert. ef. 8-1-96 HR 10-1994, f. & cert. ef. 2-15-94 HR 9-1993, f. & cert. ef. 4-1-93 HR 10-1992, f. & cert. ef. 4-1-92