Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Osteoporosis
Treatment: 82523 - Collagen crosslinks analysis 
The health plan should cover the proposed collagen crosslinks analysis because it is medically necessary, as described below.

This patient is a female diagnosed with osteoporosis. This request is for 82523 - collagen cross links analysis. 

As reported: The patient's T-score at the spine was -3.4. She has thoracic vertebral fractures. She was on Forteo; which was followed by intravenous (IV) zoledronic acid. 

The requested collagen crosslinks analysis is likely to be more beneficial than any standard treatment(s) for the insured's condition or disease.

Collagen crosslinks are not investigational as there is evidence that examining collagen crosslinks changes management and improves outcomes. There is a relationship between normalization of bone markers and clinical outcomes (1-9). Collagen crosslinks are used to determine bone turnover in patients with osteopenia or osteoporosis (1, 10, 11). Measures of bone turnover are useful in osteopenia and osteoporosis in determining the course and efficacy of treatment (1-3, 12, 13). 

Collagen crosslinks is standard of care for patients being followed on treatment with antiresorptive agents for osteopenia and osteoporosis and in whom a secondary cause of osteoporosis is suspected.  

The American Association of Clinical Endocrinologists (AACE) Medical Guidelines for Clinical Practice for the diagnosis and treatment of postmenopausal osteoporosis published in 2011, supports the use of collagen crosslinks when secondary causes of osteoporosis are suspected, when patients are being treated with antiresorptive agents, assessing fracture risk in elderly patients, and identifying patients with high bone turnover (to predict rapid bone loss) (14, 15). The National Osteoporosis Foundation also supports the use of collagen crosslinks (16). 

Biochemical markers of bone turnover may: 
1) Predict risk of fracture independently of bone density. 2) Predict extent of fracture risk reduction when repeated after three to six months of treatment with FDA-approved therapies. 3) Predict magnitude of bone mineral density (BMD) increases with FDA-approved therapies. 4) Predict rapidity of bone loss. 5) Help determine adequacy of patient compliance and persistence with osteoporosis therapy. 6) Help determine duration of 'drug holiday' and when and if medication should be restarted 

It states: "Biochemical markers of bone remodeling [e.g., resorption markers - serum C-telopeptide (CTX) and urinary N-telopeptide (NTX) and formation markers-serum bone specific alkaline phosphatase (BSAP) and osteocalcin] can be measured in the serum and urine in untreated patients to assess risk of fracture. They may predict bone loss and, when repeated after 3-6 months of treatment with FDA approved antiresorptive therapies, may be predictive of fracture risk reduction."

This patient has postmenopausal osteoporosis, and has been on antiresorptive therapy. She meets the above described criteria for collagen crosslinks. The request is consistent with generally accepted standards of medical practice and is therefore medically necessary.