Becker's Spine Review

9 SPINE Spine surgeons' biggest threats By Alan Condon F ighting for the approval of minimal- ly invasive alternatives to spinal fu- sion; non-surgeons performing cer- tain spine procedures; and insurers too oen dictating care decisions are some of the biggest threats to spine surgeons to- day, three specialists told Becker's. Question: What is the biggest threat to spine surgeons today? Colin Haines, MD. Virginia Spine Insti- tute (Reston, Va.): Spine surgeons today are faced with a huge challenge to main- tain the ability to care for their patients as they see fit. Too oen, payers dictate care based on either archaic literature or cost-cutting measures. I am concerned that the biggest threat to our patients is that, as spine surgeons, we lose ground in appropriately treating our patients. While evidence-based medicine is a cornerstone by which we all practice, large-scale pop- ulation-based medical systems oen leave the patient in the dust. In ideal medical care, each of my patients needs an indi- vidualized diagnosis and treatment plan. is level of customization is lost if we plug everyone into the same treatment al- gorithm. Big data and unilateral decisions by payers risk further loss of control over appropriately treating our patients. Brian Gantwerker, MD. e Craniospi- nal Center of Los Angeles: Healthcare consolidation continues to run counter to the free market narrative many use to say the entry of corporations into medi- cine will bring. Again, not sure who is not paying attention right now, but it's appar- ent with less and less competition, costs are going to jump. e exhaustion of this cycle and those who are in charge of the narrative saying, "we need to keep cutting costs" and the American people's health and well-being are the grist for the mill. Outstanding spine surgeons who have good results, provide a good patient experience and can effectively market themselves will remain a viable alterna- tive. ere will be more threats down the pike, for instance non-surgeons fusing the spine together or even non-physicians doing spine surgery in some form or an- other, portend a serious abyss to which we should all be aware of. Only by protecting patients and working with lawmakers can we stem the bleeding. Todd Lanman, MD. Lanman Spinal Neurosurgery and the Advanced Disc Replacement Spinal Restoration Cen- ter (Beverly Hills, Calif.): e biggest threats to spinal surgeons who perform motion-preservation surgery are the insurance companies themselves. ey routinely use third-party administrators to review authorization, and predictably, artificial disc replacement procedures are frequently denied reimbursement. Our practice finds it difficult to get ap- provals for even simple disc replacement surgeries that should be authorized without question. My hope is that insurers will soon come to realize that ADR is actually better for their customers — my patients — and will be less expensive for them in the long run. Despite overwhelming evidence demonstrating disc replacement is supe- rior to spinal fusion in the cervical spine and lumbar spine, ADR procedures are oen denied. Data gathered on ADR are one of the largest datasets on any type of operation in history — more than hip or knee replacement. Disc replacement is as good as or better than fusion in terms of pain relief and maintaining motion. When you consider the risk of adjacent-level surgery aer ADR is 20 percent to 30 percent lower than fusion, the cost savings in avoided spine surgeries is enormous. Neverthe- less, we continually fight with insurers and get denials for ADR surgeries. If spine surgeons don't win this battle, pa- tients are going to end up resorting to motion-limiting spinal fusion when they could have enjoyed the benefits of mo- tion-preserving disc replacement. n "I am concerned that the biggest threat to our patients is that, as spine surgeons, we lose ground in appropriately treating our patients." - Colin Haines, MD. Virginia Spine Institute • In patients undergoing hemorrhoidectomy, a total of 266 mg (20 mL ) of EXPAREL was diluted with 10 mL of saline, for a total of 30 mL, divided into six 5 mL aliquots, injected by visualizing the anal sphincter as a clock face and slowly infiltrating one aliquot to each of the even numbers to produce a field block. Local Analgesia via Infiltration Dosing in Pediatric Patients The recommended dose of EXPAREL for single-dose infiltration in pediatric patients, aged 6 to less than 17 years, is 4 mg/kg (up to a maximum of 266 mg), and is based upon two studies of pediatric patients undergoing either spine surgery or cardiac surgery. Regional Analgesia via Interscalene Brachial Plexus Nerve Block Dosing in Adults The recommended dose of EXPAREL for interscalene brachial plexus nerve block in adults is 133 mg (10 mL), and is based upon one study of patients undergoing either total shoulder arthroplasty or rotator cuff repair. Compatibility Considerations Admixing EXPAREL with drugs other than bupivacaine HCl prior to administration is not recommended. • Non-bupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. • Bupivacaine HCl administered together with EXPAREL may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. Therefore, bupivacaine HCl and EXPAREL may be administered simultaneously in the same syringe, and bupivacaine HCl may be injected immediately before EXPAREL as long as the ratio of the milligram dose of bupivacaine HCl solution to EXPAREL does not exceed 1:2. The toxic effects of these drugs are additive and their administration should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity. • When a topical antiseptic such as povidone iodine (e.g., Betadine ® ) is applied, the site should be allowed to dry before EXPAREL is administered into the surgical site. EXPAREL should not be allowed to come into contact with antiseptics such as povidone iodine in solution. Studies conducted with EXPAREL demonstrated that the most common implantable materials (polypropylene, PTFE, silicone, stainless steel, and titanium) are not affected by the presence of EXPAREL any more than they are by saline. None of the materials studied had an adverse effect on EXPAREL. Non-Interchangeability with Other Formulations of Bupivacaine Different formulations of bupivacaine are not bioequivalent even if the milligram dosage is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL and vice versa. Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug's functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products. Do not substitute. CLINICAL PHARMACOLOGY Pharmacokinetics Administration of EXPAREL results in significant systemic plasma levels of bupivacaine which can persist for 96 hours after local infiltration and 120 hours after interscalene brachial plexus nerve block. In general, peripheral nerve blocks have shown systemic plasma levels of bupivacaine for extended duration when compared to local infiltration. Systemic plasma levels of bupivacaine following administration of EXPAREL are not correlated with local efficacy. PATIENT COUNSELING Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue. Pacira Pharmaceuticals, Inc. San Diego, CA 92121 USA Patent Numbers: 6,132,766 5,891,467 5,766,627 8,182,835 Trademark of Pacira Pharmaceuticals, Inc. For additional information call 1-855-RX-EXPAREL (1-855-793-9727) Rx only March 2021

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