Osteogenesis Stimulator devices are a noninvasive alternative therapy to promote bone healing in fractures that have failed to heal on their own. The devices are designed to generate an electrical current to a fracture or bone fusion site to stimulate bone growth or osteogenesis. Osteogenesis stimulators are most effective in nonunion or delayed union fractures. Nonunion fractures are broken bones that fail to heal while delayed union fractures are broken bones that take more time than expected to heal. Bone growth stimulators are intended to be used as an adjunct to conventional interventions to fractures (e.g., cast immobilization, rest, or bracing).

Clinical Guideline Coverage Criteria

The Plan uses guidance from the Centers for Medicare and Medicaid Services (CMS) and MassHealth for coverage determinations for its Dual Product Eligible plan members. CMS National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Local Coverage Articles (LCAs) and documentation included in the Medicare manuals and MassHealth Medical Necessity Determinations are the basis for coverage determinations where available.

For Tufts Health One Care plan members the following criteria is used:

• NCD - Osteogenic Stimulators (150.2) (cms.gov)
• LCD - Osteogenesis Stimulators (L33796) (cms.gov)
• Article - Osteogenesis Stimulators - Policy Article (A52513) (cms.gov)

The Plan requires the use of the following InterQual® Subsets or SmartSheets to obtain prior authorization for electrical bone growth stimulators:

1. Osteogenesis Stimulator, Electrical Noninvasive, Not Spinal Applications
2. Osteogenesis Stimulator, Electrical Noninvasive, Spinal Applications
3. Osteogenesis Stimulator, Low Intensity Ultrasound, Noninvasive

Limitations

The Plan considers electrical bone growth stimulators as not medically necessary for all other indications.

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