Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Osteoporosis.
Treatment: CPT code 82523 (Collagen cross links, any method).

The insurer denied coverage for CPT code 82523 (Collagen cross links, any method). The denial is overturned. 

This patient is a female diagnosed with Osteoporosis. This request is for CPT code 82523 (Collagen cross links, any method). Her weight was 127.2 pounds (lbs), height was 161.29 cm and body mass index (BMI) was 22.2. Her T-score of the spine was -3.4, left hip was -2.4, and right hip was -2.7. Her alk phos was 89 and Calcium was 9.5. The FRAX score for this patient is reported to be 15% for a major fracture and 1.5% for hip fracture. 

In certain populations the scientific evidence in peer-reviewed literature support a result of improvement in health outcome. 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. Collagen crosslinks are used to determine bone turnover in patients with osteopenia or osteoporosis. Measures of bone turnover are useful in osteopenia and osteoporosis in determining the course and efficacy of treatment. It is standard of care for patients being followed on treatment with anti-resorptive agents for osteopenia and osteoporosis and in whom a secondary cause of osteoporosis is suspected. 

According to Greenblatt, M. B., Tsai, J. N., & Wein, M. N. (2017), "Bone turnover markers (BTMs) are a series of protein or protein derivative biomarkers released during bone remodeling by osteoblasts or osteoclasts. BTMs can offer prognostic information on fracture risk that supplements radiographic measures of bone mass, but testing using BTMs has to take into account the large number of preanalytic factors and comorbid clinical conditions influencing BTM levels. BTMs respond rapidly to changes in bone physiology, therefore, they have utility in determining patient response to and compliance with therapies for osteoporosis." 

The patient is a good candidate for CPT code 82523 (Collagen cross links, any method). The study is appropriate if a patient has been on treatment to assess for bone turnover. The study is appropriate in patients in whom the bone density does not clearly warrant treatment. The FRAX score is not in a range where treatment would be clearly appropriate. 

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 anti-resorptive agents, assessing fracture risk in elderly patients, and identifying patients with high bone turnover (to predict rapid bone loss). The national osteoporosis foundation (2009) also supports the use of collagen Crosslinks. 

Biochemical markers of bone turnover may: predict risk of fracture independently of bone density; Predict extent of fracture risk reduction when repeated after 3-6 months of treatment with FDA-approved therapies; predict magnitude of BMD increases with FDA-approved therapies; predict rapidity of bone loss; and help determine adequacy of patient compliance and persistence with osteoporosis therapy. 

CPT code 82523 (Collagen cross links, any method) is the best available test for this patient at this time. The requested service is likely to be more beneficial than any other standard testing. 
                                                    
Based on the above, the medical necessity for CPT code 82523 (Collagen cross links, any method), performed is substantiated.  The insurer's denial is overturned.