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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101.
The rules say that medically necessary services are those that are reasonable and necessary for the diagnosis or treatment of an illness or injury. Medically necessary services include services to improve the functioning of a malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). The rules say that services that are not medically necessary are not covered. The rules also say that experimental and investigational devices are not covered. You can find this rule at 42 CFR Sections 411.15 and 411.15(o). The rules say that a spinal electrical osteogenesis stimulator (E0748) is covered only if any of the following criteria are met: 1. Failed spinal fusion where a minimum of nine months has elapsed since the last surgery, or 2. Following a multilevel spinal fusion surgery (see Appendices section), or 3. Following spinal fusion surgery where there is a history of a previously failed spinal fusion at the same site. A spinal electrical osteogenesis stimulator will be denied as not medically necessary if none of the criteria above are met. You can find this information in Medicare's Local Coverage Determination (LCD): Osteogenesis Stimulators (L33796). The rules say Nationally Covered Indications: Noninvasive Stimulator: The noninvasive stimulator device is covered only for the following indications: Nonunion of long bone fractures; Failed fusion, where a minimum of 9 months has elapsed since the last surgery; Congenital pseudarthroses; Effective July 1, 1996, 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). Effective September 15, 1980, nonunion of long bone fractures is considered to exist only after 6 or more months have elapsed without healing of the fracture. Effective April 1, 2000, nonunion of long bone fractures 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. Effective January 1, 2001, ultrasonic osteogenic stimulators are covered as medically reasonable and necessary for the treatment of nonunion fractures. In demonstrating non-union fractures, CMS expects: A minimum of 2 sets of radiographs, obtained prior to starting treatment with the osteogenic stimulator, separated by a minimum of 90 days. Each radiograph set 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 2 sets of radiographs; and, Indications that the patient failed at least one surgical intervention for the treatment of the fracture. Effective April 27, 2005, upon
reconsideration of ultrasound stimulation for nonunion fracture healing, CMS determines that the evidence is
adequate to conclude that noninvasive ultrasound stimulation for the treatment of nonunion bone fractures prior
to surgical intervention is reasonable and necessary. In demonstrating non-union fractures, CMS expects: A
minimum of 2 sets of radiographs, obtained prior to starting treatment with the osteogenic stimulator, separated
by a minimum of 90 days. Each radiograph set 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 2 sets of radiographs. You can find this information in Medicare's National
Coverage Determination (NCD) for Osteogenic Stimulators (150.2).
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.