Becker's ASC Review

93 HEALTHCARE NEWS 93 Why don't physicians have more power in healthcare? By Laura Dyrda P hysicians are essential to the health- care system. ey treat patients, perform surgery, write prescriptions and conduct research advancing the field. But their opinions carry less weight on Capitol Hill than in the operating room. Health policy is shaped by legislators and influenced by lobbyists representing drug companies, medtech, insurers, hospitals and more. In the first half of 2021, health- care organizations spent $331 million on lobbying, led by Pharmaceutical Research and Manufacturing of America. e top five spenders were: Pharmaceutical Research and Manufacturers of America: $15.2 million; American Hospital As- sociation: $12.1 million; Blue Cross Blue Shield Association: $12 million; Ameri- can Medical Association: $10.9 million; and Pfizer: $6.6 million. e American Medical Association pro- motes the "art and science of medicine" to advocate on behalf of medical societies and all physicians, but their spending is overshadowed by the numerous other non-provider industry interests. It's why physicians have their Medicare pay on the chopping block during every budget negotiation. Physicians were also largely le out of Affordable Care Act discussions, which put a moratorium on physician-owned hospitals and added regulations that sparked consolidation in many specialties, which also raised prices. "Physicians have been 'relinquishing' their power in healthcare system for a long time," said Vladimir Sinkov, MD, founder and CEO of Sinkov Spine Center in Las Vegas. "e three major areas where physicians lost their influence over the healthcare system are hospi- tal control, financial relationship with the patients, and the need to practice 'defensive medicine' in an effort to avoid a frivolous lawsuit." Few hospitals are owned or operated by physicians, and insurance companies removed the direct financial relationship between patients and physicians, who oen don't know how much patients are charged. "Insurance companies control which doctors their patients can see," said Dr. Sinkov. "Since the insurance companies control the flow of patients and money, they control how the physicians practice and earn income. Furthermore, once the government got into the health insurance business, through Medicare and Medic- aid programs, the government officials, who for the most part have no medical knowledge or training, get to pass laws and regulations further controlling the physicians and how they practice." More recently, CMS surprised physicians by removing procedures from the ASC payable list and placing barriers to pay for new procedures. "e decision-makers in government are oen unaware of both the issues we face as providers and the specific sufferings of our patients, and, of course, these problems are interconnected," said C. Ann Conn, MD, of Advanced Pain Institute in Ham- mond, La. "erefore, it is important that we speak out to improve the situation." Over the last two years, physicians were front and center in treating COVID-19 patients, but it was deja-vu on Capitol Hill when it came to who was informing public health policy. "Facing the pandemic, the medical profes- sion took a back seat to the government task forces, which have made flagrant mis- steps," wrote Ronald Frank, MD, in a Wall Street Journal opinion. "While physicians treated patients, the directions of care were outlined largely by government. How can we possibly think government agencies would be more adept than the clinicians, the 'foot soldiers' in the field? Physicians have been disrespected — taken out of the equation and largely ignored or silenced in policy-making." e pandemic ushered in a new era of healthcare with an emphasis on connectiv- ity, accessibility, equity and science. But will physicians finally wrestle a seat at the table as policymakers reshape healthcare for the next generation? As healthcare spending grows, it becomes less likely, Dr. Sinkov thinks. Healthcare is big business and most physicians don't have a business background. • 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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