Becker's ASC Review

11 ASC MANAGEMENT Orthopedic surgeon's $9M win against Texas ASC overturned By Alan Condon A Texas appellate court reversed a multimillion-dollar win of an orthopedic surgeon aer a dispute with an ASC that he previously had ownership in, according to the court's opinion provided on Justia. Six notes: 1. e court nixed the more than $9 mil- lion awarded to Richard Francis, MD, and his business entity, Juansrich, on their conversion claim against Houston Metro Ortho and Spine Surgery Center, ruling that the surgeon was bound by a noncompete clause. 2. e dispute began in 2014 when two large insurers stopped paying the ASC "for services rendered to their insureds," according to court documents. Dr. Francis then began performing more procedures at other facilities, despite an agreement between surgeons at Metro to perform a certain number of procedures at the ASC. 3. Metro terminated Juansrich's owner- ship in the ASC and sued Dr. Francis in 2015, alleging that he had violated their noncompete agreement. 4. Arguing that it was owed payment for its ownership interest in Metro, as well as for missed distributions of earnings made while it was still a member of the center, Juansrich filed counterclaims that included breach of contract, conversion, aiding and abetting, and unjust enrichment, accord- ing to court documents. 5. A trial court initially granted Dr. Francis' motion for partial summary judgment, ruling that the noncompete clause was unenforce- able, and awarded Juansrich $9.9 million in damages on its conversion cause of action. 6. But the appellate court reversed the judgment July 6, saying that the "trial court erred when it granted Juansrich's first and second Rule 166 motions, which Juansrich relied on to support its breach of contract cause of action." As a result, Juansrich cannot recover on its breach of contract claim seeking payment for its ownership interest, the court said. 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 ASCs may get extra pay bump from CMS next year for 440 surgeries By Laura Dyrda W hile CMS proposed removing 258 recently added procedures from the ASC-payable list in its 2022 proposed payment rule, another policy change would add some procedures and im- prove payment for hundreds of others in the outpatient setting. CMS proposed granting device-intensive surgery status to procedures where the device is 30 percent of the ASC procedure rate, lowering the threshold for procedures to receive extra pay because costs for associated devices are so steep. Its current policy classifies device-inten- sive status as procedures where device costs exceed 30 percent of the hospital outpatient department rate, which is higher than the ASC rate. "ASCA has long asked for adequate reimbursement of codes that involve significant device costs, and a policy in this proposed rule would more appropriately cover the costs of the devices ASC physicians often implant in patients," William Prentice, CEO of Ambulatory Surgery Center Asso- ciation told Becker's. "If adopted, we expect this policy to add more than 60 device-intensive procedures to the ASC setting and provide more adequate payment for more than 440 codes." n

• Cover