Issue link: https://beckershealthcare.uberflip.com/i/148060
Executive Briefing: Outpatient Spine Surgery in ASCs 32 nology is the large learning curve to incorporate the approach into the operating room. Physicians should be vigilant as to whether or not innovation is worth the additional time required in the OR. "Most new and less invasive procedures historically have not brought a savings of time and an increasing benefit to patients and surgeons because the technology was not focused on these two things," Dr. Mathews says. "It's innovation, but not necessarily better innovation." He encourages surgeons to search for innovative devices and procedures that are designed for better outcomes than traditional procedures and that have a smaller learning curve. Data driven, simple surgeries that lessen the risks of addi- tional costs and complications are procedures that tend to last. 5. Outcomes data can justify reimbursement rates. As surgeon willingness and patient demand for innovation increases, so must the data substantiation for outpatient spine procedures to receive payor reimbursement. Outpatient procedures will weather the push for more data well, Dr. Mathews says. "ASCs can easily collect pre-op and post-op outcomes; they can collect data to justify outpatient procedures to payors and patient groups; and they can more easily provide efficacy of procedures that gets lost in big institutions," he says. He sees data-driven technology as the primary driver of innovation going forward. Technology without data-supported efficacy has little chance of adoption, especially by ASCs. "The chances of adoption or real, true innovation is not very high going forward because of the data parameters of FDA premarket approval with level 1 data," he said. "The process [of obtaining PMA] tends to open payors' and surgeons' eyes to the understanding that this is true innovation. But it will be difficult for the industry to move forward for the right reasons in the current climate. Innovation needs to have the supporting level 1 evidence from prospective RCT studies to justify its worthiness. Otherwise industry is just increasing capacity of commoditized products." n Why Spine is Coming to ASCs: 3 Big Reasons By Heather Linder H allett Mathews, MD, MBA, is the Executive Vice President and Chief Medical officer of New York City-based Paradigm Spine, LLC, a non-fusion spinal implant and device technology manufacturer. Dr. Mathews is also a board-certified orthopedic spine surgeon and minimally invasive spine surgery pioneer. gery performed in a hospital, including the increasing rates of infection and exposure to disease. Most spine candidates are not suffering from lifethreatening diseases; rather, they are looking for improved quality of life. Ambulatory surgery centers many times more accurately match the needs of patients undergoing less invasive spine procedures. Spine surgery has been drastically evolving over the past nearly 28 years since Dr. Mathews began practicing. The industry's latest phase of development includes surgeons performing procedures in outpatient centers rather than inpatient facilities. "Patients are starting to realize you only go to a hospital if you have to," Dr. Mathews says. "You can have appropriately invasive spine procedures done in a relaxed, non-threatening, collegial setting." Here are Dr. Mathews' three points on why spine surgery is moving toward outpatient surgery centers and away from inpatient institutions. Technological development Dr. Mathews credits much of the transition to the development of more appropriately invasive techniques. Spine surgery has transitioned from a one incision and one-operation-fits-all approach to more patient- and disease-specific operations, he says. "Surgeons have gotten better diagnostically," Dr. Mathews says. "They can see specific pathologies on advanced technology imaging that correlates to clinical symptoms and now they can address disease using small incisions effectively." Most patients view ASCs as friendly and non-threatening, whereas larger institutions and hospital systems can create fear and apprehension. Spine surgeons want more control While patients benefit from the cleanliness and relaxed atmosphere of surgery centers, the implications of outpatient spine also excite surgeons. Outpatient settings, largely due to the smaller size and ownership structure, allow physicians more input and control than hospitals. Physicians can have a say in the devices purchased and used, the center's turnover time, personnel in the operating room and pre- and post-operative management, Dr. Mathews says. Surgeons can now let the pathology dictate the care. And because of the evolution in surgical approaches, more surgeons are finding outpatient surgery centers to be more suitable settings for care. "The turnover time in a large institution can be anywhere from one to two hours because of staffing, lack of focus and a one-size-fits-all approach," he says. "In contrast, you often find outpatients settings to have very efficient turnover from room to room." "Surgeons can now address the pathology in a setting that is appropriate for the patient's pathology and health status," he says. "They have the ability to undergo surgery in a safe and comfortable environment and can avoid the hospital if they'd like." Staff members working in surgery centers are often happier and more productive than some hospital staff because they do not have to work late into the evening finishing tasks that should've been done earlier but were delayed by inefficiencies, he says. Patients prefer the outpatient setting "Surgeons are more efficient; patients don't have to wait as long," he says. "Surgeons like the control of the outpatient setting versus the lack of control in an institution." n Patients are becoming more aware of the risks posed by having spine sur- PARADIGM SPINE Paradigm Spine, LLC, a Delaware limited liability company, was founded in 2005 to be the leading provider of novel posterior non-fusion spinal implant technologies for the global spine market. The Company is the first to U.S. market with its proprietary coflex® inter-laminar technology to treat moderate to severe spinal stenosis. Today, Paradigm Spine, LLC has offices in New York, NY and Wurmlingen, Germany and employs over 76 people world-wide. The Company sells its four core medical device products in more than 45 countries worldwide.