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Bone Stimulators, Electronic & Ultrasonic - DME

These services may or may not be covered by all HealthPartners plans. Please see your plan documents for your own coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. Administrative Process

Requires prior approval.

Coverage

Generally covered subject to the indications listed below and following limits from your member contract: 1. Durable medical equipment (DME) is limited by the following: a. All covered DME items should be the acceptable standard model, considering the member's medical condition. If a member requests an additional item/part, which is safe and effective, HealthPartners may cover the cost up to the cost of the acceptable standard model. b. Payment will not exceed the cost of an alternate piece of equipment or service that is effective and medically necessary. Prosthetic benefits have some variation. Please see your member contract or specific medical coverage criteria for details. c. We reserve the right to determine if an item will be approved for rental vs. purchase. DME items will not be approved which are primarily educational in nature or for hygiene, vocation, comfort, convenience or recreation. DME and supplies must be obtained from or repaired by approved vendors. Duplicate or similar items are not covered. Requests for replacement DME when existing DME is not broken, requires a physician statement documenting a change in the covered person's physical condition, and the medical reasons for the replacement DME.

2. 3. 4.

Indications that are covered

Electrical Bone Stimulator, Noninvasive (E0747, E0748) 1. Nonspinal Bone Stimulators (E0747 - osteogenesis stimulator, noninvasive, other than spinal applications) are covered for fractures that have a gap of less than 1cm or one-half the bone diameter, and: a. Show no progression toward healing based on radiographs taken at 1 month intervals for at least 3 months prior to the start of electrical treatments; OR b. Have been surgically treated but fail to show evidence of union; OR c. Nonunion of a fracture after 6 or more months have elapsed without healing of the fracture; OR d. A fracture complicated by congenital pseudoarthrosis; OR e. A documented failed fusion of a joint other than in the spine; OR f. In conjunction with surgery, certain fractures associated with high-risk of nonunion will be covered on a case by case basis. Spinal bone stimulator (E0748 - osteogenesis stimulator, noninvasive, spinal applications) is covered if any of the following criteria are met: a. Failed spinal fusion where a minimum of 9 months has elapsed since the last surgery; OR b. Following a multilevel spinal fusion surgery. A multiple level fusion involves 3 or more vertebrae (e.g., L3-L5, L4-S1, etc.); OR c. Following spinal surgery where there is a history of a previously failed spinal fusion.

2.

Electrical Bone Stimulator, Invasive (E0749) An invasive bone stimulator device is covered only for the following indications: 1. Nonunion of long bone fracture; OR

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2.

As an adjunct to spinal fusion surgery for patients at high risk of pseudarthrosis due to previously failed spinal fusion at the same site or for those undergoing multiple level fusion. A multiple level fusion involves 3 or more vertebrae (e.g., L3-L5, L4-S1, etc).

Nonunion of a long bone fracture is considered to exist only when serial radiographs have confirmed that fracture healing has ceased for 3 or more months prior to starting treatment with the electrical osteogenic stimulator. Serial radiographs must include a minimum of 2 sets of radiographs, each including multiple views of the fracture site, separated by a minimum of 90 days. Ultrasonic Bone Stimulator (E0760) Ultrasonic osteogenic stimulators are covered as medically reasonable and necessary for the treatment of non-union fractures of all bone types. In demonstrating nonunion of fractures, we would expect: A minimum of two sets of radiographs obtained prior to starting treatment with the osteogenic stimulator, separated by a minimum of 90 days. Each radiograph must include multiple views of the fracture site accompanied 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. Ultrasonic bone stimulators are also covered for the following types of fresh (7 days or less) fractures: 1. Closed or grade 1 open, tibial diaphyesal fractures treated with closed reduction and cast immobilization in skeletally mature patients 2. Closed fractures of the distal radius (Colles' fractures) treated with closed reduction and cast immobilization in skeletally mature patients.

Indications that are not covered

Electrical Bone Stimulator, Noninvasive 1. Not covered for any indications other than those described above due to insufficient supporting scientific literature. 2. Bone growth stimulators are not covered for recipients who have any contraindication listed in the device's package insert (e.g. recipients who are pregnant or nursing). Ultrasonic Bone Stimulator 1. 2. 3. Non-unions of the skull, vertebrae, and those that are tumor-related are excluded from coverage. The ultrasonic osteogenic stimulator may not be used concurrently with other non-invasive osteogenic devices. Bone growth stimulators are not covered for recipients who have any contraindication listed in the device's package insert (e.g. recipients who are pregnant or nursing)

Definitions

Electrical stimulation to augment bone repair can be attained either invasively or noninvasively. Invasive devices provide electrical stimulation directly at the fracture site either through percutaneously placed cathodes or by implantation of a coiled cathode wire into the fracture site. The power pack for the latter device is implanted into soft tissue near the fracture site and subcutaneously connected to the cathode, creating a self-contained system with no external components. The power supply for the former device is externally placed and the leads connected to the inserted cathodes. With the noninvasive device, opposing pads, wired to an external power supply, are placed over the cast. An electromagnetic field is created between the pads at the fracture site. An ultrasonic osteogenic 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 gel in order to stimulate fracture healing.

Vendor - Specialty

· · Item must be received from a contracted specialty vendor or from the contracted clinic or specialty provider. Specialty vendors provide only certain specific items such as compression garments, diabetes supplies, TENS units, bone stimulators and etc.

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Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy contact Member Services at 952-883-7979 or 800-233-9645. Number D050-09; Approved Medical Director Committee 10/01/97; Revised 10/25/01, 5/17/05, 2/7/06, 8/11/11, 12/1/11; Annual Review 2/7/06, 8/1/07, 8/1/08, 9/9/09, 6/1/10, 6/2011, 12/2011.

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