5101:3-10-28 Non-invasive bone (osteogenesis) stimulators.

(A) Definition

(1) An electrical bone (osteogenesis) spinal or nonspinal stimulator is a device that provides electrical stimulation to augment bone repair. A non-invasive electrical bone 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.

(2) An ultrasonic bone (osteogenesis) stimulator is a non-invasive device that emits low intensity, pulsed ultrasound. The ultrasound signal is applied to the skin surface at the fracture location via ultrasound conductive coupling gel in order to stimulate fracture healing.

(B) Coverage determination

(1) A nonspinal electrical bone stimulator is covered only if any of the following criteria are met:

(a) Nonunion of a long bone fracture, defined by radiographic evidence that fracture healing has ceased for three or more months prior to starting treatment with the bone stimulator and documented by a minimum of two sets of radiographs obtained prior to starting treatment with the bone stimulator, separated by a minimum of ninety days, each including multiple views of the fracture site, and with a written interpretation by a physician stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs;

(b) Failed fusion of a joint other than the spine where a minimum of nine months has elapsed since the last surgery; or

(c) Congenital pseudarthrosis.

(2) A nonspinal electrical bone stimulator will be denied as not medically necessary if none of the criteria listed in paragraph (B)(1) of this rule are met.

(3) A spinal electrical bone stimulator is covered only if any of the following criteria are met:

(a) Failed spinal fusion where a minimum of nine months has elapsed since the last surgery;

(b) The consumer has undergone a multilevel spinal fusion surgery; or

(c) The consumer has undergone spinal fusion surgery where there is a history of a previously failed spinal fusion at the same site.

(4) A spinal electrical bone stimulator will be denied as not medically necessary if none of the criteria listed in paragraph (B)(3) of this rule are meet.

(5) An ultrasonic bone stimulator is covered only if all of the following criteria are met:

(a) Nonunion of a long bone fracture documented by a minimum of two sets of radiographs obtained prior to starting treatment with the bone stimulator, separated by a minimum of ninety days, each including multiple views of the fracture site, and with a written interpretation by a physician stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs;

(b) Fracture is not of the skull or vertebrae; and

(c) Fracture is not tumor-related.

(6) An ultrasonic bone stimulator will be denied as not medically necessary if all of the criteria listed in paragraph (B)(5) of this rule are not met.

(7) In order to qualify for the use of any bone stimulator, a consumer that is twenty years of age or younger must meet all of the following criteria in addition to the medical criteria for the applicable bone stimulator prescribed listed in paragraphs (B)(1), (B)(3) and (B)(5) of this rule:

(a) There is radiological documentation that skeletal maturity has been attained;

(b) The fracture gap is not more than one-half of the diameter of the bone to be treated; and

(c) The fracture does not involve a vertebrae.

(C) Non-coverage determination

(1) Bone (osteogenesis) stimulators are considered noncovered if any of the following contraindications exist:

(a) Fracture of short or flat bones or epiphyses;

(b) Fracture as a result of cancer;

(c) Fractures that need additional reduction or are comminuted;

(d) Fractures with post-reduction displacement of greater than fifty per cent;

(e) Fractures with internal or external fixation;

(f) Fracture gaps greater than one centimeter;

(g) Avascularity, vascular insufficiency or other vascular problems (e.g.,thrombophlebitis) or severe osteoporosis;

(h) When stimulator is to be used in conjunction with medications that may interfere with or alter bone metabolism and healing;

(i) When osteomyelitis, active infections or necrotic bone is present;

(j) Paget's disease, renal disease or diabetes;

(k) Sensory paralysis; or

(l) Synovial pseudoarthritis.

(2) Consumers with demand type pacemakers in proximity to the proposed treatment site are not eligible for electric bone stimulators.

(D) Prior authorization

A fully completed form JFS 07134 (rev. 2/2006), "Certificate of Medical Need/Prescription Non-Invasive Bone Growth (Osteogenesis) Stimulator" (CMN) (appendix A to this rule) that is signed and dated no more than thirty days prior to the first date of service must be submitted for prior authorization (PA) before reimbursement for a bone stimulator will be considered.

(E) Dispensing

(1) The following components are considered "inclusive" with any bone stimulator device payment made by the department on behalf of a consumer and cannot be submitted to the department for separate reimbursement:

(a) Any supporting wires, power supply, cables, attachment kits or disposable items such as electrodes, or in the case of the ultrasound stimulator, coupling gel;

(b) Stimulator education, training, monitoring, or counseling in support of the consumer's ordered treatment;

(c) Maintenance, repair, or cleaning services; or

(d) Delivery or set-up services.

(2) The provider of the bone stimulator must assure that the consumer utilizing the device is properly instructed on how to use the device in support of the ordered treatment and is aware of and understands any emergency procedures regarding the use of the bone stimulator device. The provider must maintain written documentation regarding the consumer's instruction on the use of the bone stimulator in the consumer's medical record.

(3) A bone stimulator may not be used concurrently with any other bone stimulator device on the same fracture site.

(4) Upon dispensing of a bone stimulator device, the consumer must be supplied by the provider with a twenty-four hour, seven day a week telephone number to be utilized in case an emergency situation arises concerning the device. This telephone number must meet all federal Americans with Disabilities Act (ADA) of 1990 requirements.

(F) Reimbursement

Bone stimulator devices are reimbursed according to the department fee schedule contained in appendix DD to rule 5101:3-1-60 of the Administrative Code or the provider's usual and customary charge, whichever is less.

Appendix A

Certificate of Medical Necessity/Prescription Osteogenesis Bone Stimulators

See Appendix A at

http://emanuals.odjfs.state.oh.us/emanuals/DataImages.srv/emanuals/pdf/pdf_forms/31028APX.PDF

Effective: 10/15/2006
R.C. 119.032 review dates: 10/01/2011
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021