Becker's Spine Review

12 SPINE SURGEONS ISASS releases statements on bone graft substitutes, vertebral augmentation By Laura Dyrda T he International Society for the Advancement of Spine Surgery released statements focused on bone gra substitutes and examining vertebral augmentation. e statements outline historical use and U.S. regulatory pathways for various bone gras. "Bone graing is an essential part of spinal surgery and ever-evolving science," conclud- ed the recommendation authors. "With each new advance, one needs to understand the characteristics of material, its mechanism of action, the regulatory pathway by which it came to market and the preclinical and hu- man clinical evidence available on which to base a clinical use decision." e recommendations authors made: • Nonstructural cancellous allogra is a viable option. • Published studies support the use of DBMs and synthetic bone substitutes as autogra extenders. • While cellular allogra materials are marketed under the FDA's HCT/P guid- ance, there isn't evidence to support broad use. • ere is evidence to support appropri- ate aspirated bone marrow aspirate use as an adjunct to bone graing during fusion. • Two pre-market approval products in the drug-device category that show promise as safe and effective allogra replacements are Medtronic's InFuse and Cerapedics' i-FACTOR. "e value of the bone gra substitute recom- mendations and coverage criteria is to give sur- geons the tools they need to make an educated decision regarding bone gra substitute choice in a value based setting and to know the par- ticular clinical pathway required for same to gain approval," said Morgan Lorio, MD. "Just because a material has an FDA guidance label doesn't mean that it works and has solid data behind it." e statement also reiterates the importance of collecting supportive data by industry. Looking ahead at innovations in stem cell products, Dr. Lorio sees a narrow time win- dow for manufacturers engage with the FDA in a collaborative guidance process during this discretionary period so that regulatory requirements are not side-stepped. "ose companies that self-launch must self-invest with quality research and collabo- rative engagement with the FDA to strength- en that relationship. Unless there is solid data to support product claims, many biologic CBMs will simply go away," said Dr. Lorio. ISASS also issued a policy statement on verte- bral augmentation to outline the procedure's background aer collecting clinical evidence to support the procedure. "Given the abun- dance of high-quality information, ISASS can confidently advocate that there is strong sup- port for vertebral augmentation in the treat- ment of symptomatic vertebral compression fractures," according to the statement. e 2010 AAOS Guidelines and a recent Jour- nal of Bone and Mineral Research report by non-experts question the efficacy of vertebral augmentation. A paper published within Oste- oporosis International demonstrates real-world insight into the higher risk of mortality im- posed on patients with vertebral compression fractures, treated with a philosophy of 'intelli- gent neglect.' "Untreated compression fractures lower one's lifespan by approximately four years as demonstrated by Edidin et al; non-surgical management rations lives," said Dr. Lorio. e statement also addresses the cost-effec- tiveness of vertebral augmentation, citing studies that show non-surgical, conservative management of female patients with VCF continues to cost the healthcare system five years aer the fracture occurs. On the other hand, balloon kyphoplasty and vertebroplas- ty are proven cost-effective in terms of cost per quality year gained when compared with non-surgical management. "Although the initial cost of the intervention is higher, balloon kyphoplasty is more cost effective than vertebroplasty by providing better pain control and decreasing costs re- lated to oral narcotics in addition to provid- ing survival benefit," according to the ISASS statement. In addition to providing background informa- tion and study review analysis, the statement makes clinical indication for coverage recom- mendations and provides a discussion of cod- ing and documentation requirements. "Vertebral augmentation procedures (verte- broplasty and kyphoplasty) are safe and effec- tive procedures that have been highly stud- ied," the statement authors conclude. "e level 1 evidence is overwhelming in favor of vertebral augmentation when compared to conservative management." n California neurosurgeon charged with billing fraud: 3 points By Laura Dyrda A neurosurgeon in Carmichael, Calif., has been charged with billing fraud, according to KCRA 3, a local NBC affiliate. Three quick notes: 1. Laura Anderson, MD, was charged with submitting more than $500,000 in fraudulent insurance claims. 2. Between 2013 and 2018, Dr. Ander- son allegedly billed for procedures she didn't perform. 3. Dr. Anderson is also accused of changing the billing codes for X-ray and telephone consultations to codes for other procedures with higher reim- bursement, according to a Fox report.n

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