Appeal type: Medical necessity
Decision: Upheld

This is a patient with a history of an injury to his mid back. He underwent conservative treatment with physical therapy and then pain management with Aleve. The request is for a thoracic (T) 4, kyphoplasty.
He was seen for an initial evaluation. He had a previous mid back injury  and was diagnosed with an acute compression fracture of T4 without evidence of retropulsion of bone or severe neurologic impingement. Currently, he reported pain 8/10 with a burning sensation in the interscapular region. He had undergone some type of injections times three (x3) in the remote past with temporary relief. He had undergone physical therapy and chiropractic care in the past. His exam noted intrascapular region pain with deep palpation. There was discomfort with protraction and retraction in the same region. Anterior-posterior (AP) and lateral radiographs performed on the thoracic spine demonstrated kyphotic deformity with anterior wedging of T4. Medication included hydrocodone 5/325 milligrams (mg). The plan was for a magnetic resonance imaging (MRI) scan, bone density and Lidoderm patch 5%.
He had an MRI of the thoracic spine without contrast. The clinical history states a history of a compression fracture three years ago with a recent reinjury. The findings stated there was mild to moderate chronic wedge compression of T4. There were minor chronic compression, superior endplate T5, with minor marrow edema which could indicate ongoing compression. There was increased upper dorsal kyphosis and minor dextroscoliosis, upper to mid thoracic spine. The impression stated a chronic T4 compression fracture and a subacute T5 compression fracture. At T6-7 there was a disc protrusion with cord compression. Increased dorsal kyphosis and minor scoliosis. It is noted that a single level kyphoplasty at T5 was approved by the health plan. The health plan noted the T4 was denied as the fracture was greater than 4 months old. At issue is the medical necessity of the requested T4 kyphoplasty procedure.
The health plan's determination is upheld. The requested procedure, T4 kyphoplasty is not medically necessary since it occurred years ago and is chronic. The patient's fracture at T4 is due to an injury. There is no clear indication that he has osteoporosis, a steroid induced fracture, metastatic disease or multiple myeloma, hemangioma or unstable fracture due to osteonecrosis. Kyphoplasty, a minimally invasive technique for fracture reduction and stabilization, has been shown to reduce pain and restore vertebral body height in patients with vertebral compression fractures (VCFs). Analyses comparing treatment outcomes of acute versus chronic VCFs have not yet been reported. (3) Osteoporotic vertebral compression fracture (OVCF) is a common disease in the aged population that can greatly affect the quality of life. Percutaneous kyphoplasty (PKP) has become a mainstream approach for treating OVCF, but the optimal surgical timing for treating OVCF with PKP remains controversial. (4)
He has evidence of cord compression at T6-7. Continuous developments are evolving in the field of vertebroplasty and kyphoplasty. For this reason, it is recommended to follow the guidelines of national and international societies.
The main indication for vertebroplasty and kyphoplasty are:
Intractable, intense pain adjacent to the level of the fracture in patients with osteoporotic fractures, diagnosed by radiographs, computed tomography (CT) or MRI. Conservative management for at least 3-4 weeks should have failed in these patients for the procedure to produce clinically relevant pain relief, in the absence of need for surgical stabilization.
Pain of the affected segment in patients with osteolytic lesions of vertebral bodies from bony metastases.
Absolute contraindications to vertebroplasty and kyphoplasty are:
1. Unmanageable bleeding disorder
2. Improvement of the symptoms of the patient with conservative management
3. Asymptomatic vertebral body fracture,
4. Local or generalized infection
5. Allergy to bone cement
6. Tumour mass with involvement of the spinal canal.

Vertebral augmentation as prophylaxis in patients with osteoporosis is debated. It is regarded as a contraindication in some guidelines. On the other hand, it has been advocated by other authors for patients at very high risk for fracture.

The Consensus Guidelines for Vertebroplasty developed by the Standards of Practice Committee of the Society of Interventional Radiology are:

1) painful primary and secondary osteoporotic vertebral compression fracture(s) refractory to medical therapy;
2) painful vertebrae with extensive osteolysis or invasion secondary to benign or malignant tumor; and
3) painful vertebral fracture associated with osteonecrosis. (1)

Rollinghoff et al. published a consensus among 160 expert practitioners on the indications and contra-indications of cement augmentation in OVF. Indications were: (1) painful osteoporotic OVF that does not improve with 2-3 weeks of nonsurgical care, (2) hospitalization as a result of painful OVF, (3) painful pathologic fracture, (4) aggressive hemangioma, and (5) Kummell disease. Absolute contraindications were: (1) asymptomatic fractures, (2) history of vertebral body osteomyelitis, (3) allergy to bone fillers, and (4) irreversible coagulopathy. Relative contraindications were: (1) presence of radiculopathy, (2) bone retropulsion against neural structures, (3) >70% collapse of vertebral body height, and (4) multiple pathologic fractures. When cement augmentation is indicated, evidence does not help in the choice between kyphoplasty and vertebroplasty. Cement augmentation is not recommended when the OVF is less than 1 month old, even with recent evidence of better pain management with early (less than [<] 2 days) vertebroplasty. If pain persists after one month of medical management cement augmentation is indicated. The percentage of compression of the vertebral body determines whether to use vertebroplasty or kyphoplasty. OVF with a collapse less than (<) 30% are an indication for vertebroplasty whereas OVF with a collapse >30% are an indication of kyphoplasty. When more than 3 months have passed since the fracture incidence, and when cement augmentation is indicated, only vertebroplasty could be used, as kyphoplasty does not offer the kyphosis correction anymore. (2)