Becker's Spine Review

9 SPINE SURGEONS Spine surgeon sees TPAs reject procedures approved by insurer's policy By Laura Dyrda O rthopedic and spine surgeons have watched the preapproval process become more rigorous over the past few years, and one reason is third-party adminis- trators, said Scott Blumenthal, MD, partner at Texas Back Institute in Plano. Insurance companies are increasingly using TPAs to process requests for surgery. One large insurer in Texas recently contracted with a TPA that denies prior authorizations for lumbar artificial disc replacements for patients who underwent previous spine surgery despite clinical evidence showing the procedure is effective for those patients. "e insurance companies use TPAs because they have more restrictive policies," said Dr. Blumenthal. "ey've come up with an exclusion for lumbar disc replacements that is anti-science because patients do well with this technology aer a prior surgery. It was part of the indications approved in the FDA trial." Dr. Blumenthal has had conversations with the payer about the denials, despite the pay- er's policies explicitly covering lumbar disc replacement for patients with prior surgery, but hasn't been able to reverse the coverage decision. He also spoke with the TPA, AIM, which continues to deny coverage through the peer-review process. is isn't the first time Dr. Blumenthal and his colleagues at Texas Back took on an in- surance company's approval process. UnitedHealthcare previously developed policies for lumbar disc replacements that denied coverage for patients with prior surgery. Dr. Blumenthal, Richard Guyer, MD, and Jack Zigler, MD, conducted a substudy of the FDA study and detailed the results of patients with prior surgery in a letter to United. e results showed patients with prior surgery had better outcomes than patients without prior surgery. "United changed their policy within months," said Dr. Blumenthal. Anthony Romeo, executive vice president of the Musculoskeletal Institute of Downers Grove, Ill.-based Duly Health and Care, formerly DuPage Medical Group, had a similar experience with changing approval policies. He initially obtained preapproval for a pa- tient's surgery, but aer the patient was sedated, his office received a call from the insurer saying the code on the patient's prior authorization was wrong and it would no longer pay for surgery that day. He had to conduct a peer-to-peer review to gain approval, which he did while the patient waited. "ey did have the wrong code. We changed the code, and I immediately got an approval reference number," Dr. Romeo said. "We went ahead with the procedure. at's crazy. at's not in the best interest of patient care, and taking [prior authorizations] too far." Alok Sharan, MD, of NJ Spine and Wellness in East Brunswick, N.J., said the lack of con- sistent policies between insurance companies for prior authorizations and coverage casts doubt on the preapproval process. "It is interesting to see the variability in medical guidelines among the insurance com- panies," said Dr. Sharan. "I've had instances where a patient was denied spine surgery by one insurance company. ey enrolled in another insurance plan and were subsequently approved for surgery. is contradiction clearly is not good for delivering high-value patient care." n • 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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