Osteoporosis denials in California external review

What the reviewers wrote

Where the denial was overturned

Physician 1The patient is a 65-year-old woman who has been diagnosed with Gaucher’s disease type I. The patient has been receiving enzyme replacement therapy for several years. She underwent a left knee replacement one year ago for unknown reasons with some residual tenderness noted three months later. The submitted notes indicate there was a small area of avascular necrosis at the superior aspect of the right femoral head seen on an MRI performed in May 2003. This was presumably a stage I lesion since it was not seen on x-ray. X-rays of the spine, hips, and knees show only minimal disc and degenerative joint changes without fractures, lytic lesions or deformities such as the Erlenmeyer flask deformity classic for Gaucher’s disease. DEXA scans of the spine and hip for bone mineral density reveal normal T scores compared to young adult women and no evidence of osteoporosis.

The patient requested reimbursement for the lab testing (collagen cross-links testing).Osteoporosis is a common metabolic bone disorder characterized by a structural deterioration of bone tissue resulting in an increased risk of fragility fracture. Osteoporosis is most common in post-menopausal women. The risk of osteoporosis is increased with aging in both men and women. Currently, bone mineral density (BMD) measurement using dual-energy X-ray absorptiometry (DEXA) scan is the gold standard for the diagnosis of osteoporosis. The absolute fracture risk in individual subjects is calculated using algorithms, which include BMD, age, gender, history of prior fracture, and other risk factors. Accelerated bone turnover is associated with a higher risk of fracture independent of age, gender, or underlying diseases.

Where the denial was upheld

Physician 1: The patient is a 63-year-old man with thin bones (osteopenia), documented on a bone density (DEXA) scan 8.5 years ago. He was treated with Aredia, an intravenous bisphosphonate for an unknown amount of time. There is no evaluation as to the cause of the osteopenia. The patient was apparently unable to tolerate the oral bisphosphonates, Fosamax and Actonel. There is no documentation of any response to treatment. The patient’s primary care physician decided to restart the Aredia, apparently based on the findings of osteopenia on a lumbar spine x-ray finding performed a year before. Based upon the documentation provided, it is not known if the patient’s condition is progressive. It is not known if the patient was offered Forteo, which is FDA approved for severe primary osteoporosis in men.

Findings: The physician reviewer found that The patient has requested authorization and coverage for Evenity 210 mg syringes. Bandeira and colleagues note, “Monthly subcutaneous dosing of romosozumab reduces the risk of vertebral and clinical fractures in women with postmenopausal osteoporosis, with a favorable balance of benefits and risks.” However, the authors conclude, “Romosozumab is a promising emerging anabolic agent with a novel mechanism of action that may expand the options for treating osteoporotic patients at high risk of fracture.” Paik and Scott report, “In pivotal phase III trials (FRAME and ARCH), 12 months’ once-monthly romosozumab 210 mg significantly reduced vertebral and clinical fracture risk versus placebo and oral alendronate in postmenopausal women with osteoporosis.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving osteoporosis, then check the rights and deadlines that apply to your plan.