Public Policy Committee Update

Blue Cross and Blue Shield Association and Vertebral Fracture Assessment: Vertebral fracture assessment (VFA) has been recognized by the Centers for Medicare and Medicaid Services (CMS) as a valuable means of identifying individuals with fragility fractures. Reimbursement by CMS for performance of this service has been authorized (OsteoFlash®, November 2004). However, the Blue Cross and Blue Shield (BCBS) Association’s Medical Advisory Panel (MAP) has ruled that VFA does not meet Technology Evaluation Center (TEC) criteria. Blue Cross and Blue Shield Association is an association for 41 independently owned and operated Blue Cross and Blue Shield Plans and their subsidiaries. Although BCBS Association (national) does not suggest reimbursement for VFA, each BCBS Plan is a separate company and makes its own coverage decisions.

To be approved according to TEC criteria a technology must have final approval from the appropriate governmental regulatory bodies and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes. The MAP acknowledged that DXA devices and additional software to perform VFA have received marketing clearance from the U.S. Food and Drug Administration. The panel stated, however, that the available evidence is insufficient to assess what health outcomes would result from using vertebral assessment with DXA as a screening test for osteoporosis.

The BCBS MAP felt that the case for VFA depended upon the strength of evidence underlying the following 4 critical assumptions: 1. Prevalent vertebral fractures predict future osteoporotic fractures 2. Vertebral assessment identifies additional patients who are potential candidates for pharmacologic treatment based on the presence of fracture 3. Vertebral fractures are accurately identified with vertebral assessment using DXA 4. Patients identified benefit from pharmacologic treatment

The MAP concluded that the scientific evidence supports the first three assumptions. Several observational studies have shown that prevalent vertebral fractures are a risk factor for future fragility fractures and two studies have found substantial numbers of persons who may have vertebral fractures despite bone mineral density levels above treatment thresholds. It was also concluded that the diagnostic performance of VFA is reasonable in accurately detecting vertebral fractures. However, the committee stated that evidence for the fourth assumption is lacking: “There is a lack of clinical trial evidence showing that patients with vertebral fractures but with bone mineral density levels above treatment thresholds benefit from treatment.” The MAP further stated that “The evidence does not permit conclusions that VFA using DXA improves net health outcomes over the current practice of assessing osteoporosis risk using bone mineral density measurement alone.” A full copy of the report is available at www.bcbs.com/tec. The ISCD Public Policy Committee feels that VFA is a cost-effective and practical means of identifying patients at high risk for fragility fractures that may not be treated if diagnosis and risk stratification is based solely on BMD measurements. Patients with prevalent vertebral fractures, independent of their BMD findings, are at high risk of subsequent fragility fractures. Currently available treatments have demonstrated efficacy in preventing both first and subsequent fractures. The surgeon general report stated that the direct costs for osteoporotic fractures are up to $18 billion each year. (You may access the report from the ISCD home page.) That number is expected to increase if action to prevent osteoporosis is not taken now. Inclusion of VFA in screening evaluations for osteoporosis would greatly enhance our ability to identify individuals for whom treatment could reduce these financial, not to mention personal, costs. The Public Policy Committee is appealing the BCBS Association’s TEC assessment.

Last modified: October 24, 2017