Becker's Spine Review

9 SPINE SURGEONS California neurosurgeon gets 15 months in prison for taking kickbacks By Laura Dyrda N eurosurgeon Jeffrey David Gross, MD, was sentenced May 22 for his role in a scheme that referred patients to Pacific Hospital in Long Beach, Calif., in ex- change for kickbacks, according to a Sierra Sun Times report. Four details: 1. Dr. Gross was sentenced to 15 months in federal prison and ordered to forfeit $622,936 he received in bribes and kickbacks for his referrals. He pleaded guilty to participating in the fraud scheme in August 2020. 2. Pacific Hospital's owner, Michael Drobot, allegedly paid kickbacks to surgeons, chiro- practors and marketers to refer workers compensation patients to his hospital. Dr. Gross was part of the arrangement from 2008 to 2013. 3. Dr. Gross sublet space in his practice, Oasis Medical Providers, to a Pacific Hospital-af- filiated company in return for $15,000 monthly payments, and also contracted with the company to sell its accounts receivable and other tangible assets. 4. In 2009, Dr. Gross contracted with Pacific Hospital for outsourced collections and re- ceived 15 percent of payments the hospital collected from those surgeries he performed. He also received 10 percent of collections on outpatient surgeries and was given $5,000 if he used implants from a company Mr. Drobot formed. 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 Former Sanford Health neurosurgeon to pay $4.4M to resolve kickback charges By Alan Condon N eurosurgeon Wilson Asfora, MD, and two medical device distrib- utors he owns, Medical Designs and Sicage, agreed to pay $4.4 million to settle False Claims Act allegations. Medical Designs and Sicage will also pay an additional $100,000 to re- solve allegations that they violated the open payments program by failing to report to CMS Dr. Asfora's ownership interests in the companies. Dr. Asfora, Medical Designs and Sicage will not be permitted to participate in federal healthcare programs for six years, the Department of Justice an- nounced May 3. Sioux Falls, S.D.-based Sanford Health, the neurosurgeon's former employ- er, had previously agreed to pay $20 million and submit annual audits for the next five years to settle his role in the kickback scheme. In October, Medtronic also agreed to pay over $9.2 million to settle allega- tions that it footed the bill for events held at a restaurant Dr. Asfora owned to induce him to use certain implants. Two surgeons at Sanford Health, Dustin Bechtold, MD, and Bryan Wellman, MD, blew the whistle on Dr. Asfora's alleged defrauding of CMS. They will receive $880,000 of the settlement proceeds. n

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