THIS WEEK'S ARTICLES
Do You Have What It Takes for Outpatient Spine?
A pioneer in the field answers three pressing questions that face any facility looking to launch this enticing service line.
Many in the ASC industry are buzzing about outpatient spine, which certainly wasn't the case more than two decades ago when Robert S. Bray, Jr., MD, founded DISC Sports & Spine Center in Newport Beach, Calif. Today, DISC is one of the most well-known names in outpatient spine, and Dr. Bray and Chief Operating Officer Karen Reiter have seen everything you can imagine. Recently, they jointly answered three questions they regularly hear from facilities interested in outpatient spine.
What is the upfront investment?
"It costs a lot of money to do this well. From an equipment standpoint, you need a C-arm ($160,000 and up), special spine tables ($45,000 to $100,000), surgical microscopes ($150,000 to $275,000) and instrumentation that includes drills (approximately $35,000), retractors ($15,000 to $20,000 each) and instrument trays that are specific to your facility's surgeons and case mix. You need to properly evaluate if your case volumes and margins justify these costs. For instance, we needed to exceed 300 cases per year to scale margins enough to cover equipment costs."
What staffing challenges are inherent to spine?
"Finding and training the right people is only part of the staffing challenge you face. The variability of staffing your facility appropriately is a jigsaw puzzle that takes a little creativity and a lot of organizational wizardry. In the beginning, you're going to spend a significant amount of time adapting to the flow and finding the right combination of full-time and per diem staff to account for the inconsistency of cases you're likely to run into. To this day, staffing is a challenge for us. We can do seven cases one day and none the next."
What is the most important thing surgical facility leaders need to know about outpatient spine reimbursement?
"Reimbursement varies greatly from payer to payer, and the codes for outpatient spine are changing almost daily, so you need to stay on top of what your contract says and what your surgeons are doing in the OR. From a coding standpoint, these aren't simple procedures. There is a plethora of codes for every case, and they can change drastically with one word. Make sure everything that was documented matches up with what was authorized preoperatively.
"For instance, consider a procedure performed on a patient with a ruptured disc. Normally, you would post this as a microdiscectomy because the surgeon always does a decompression on the way into the disc. Now let's say the surgeon dictates that spinal stenosis, separate from the herniated disc, is a part of that patient's diagnosis. Dictating that stenosis diagnosis completely changes the coding and, as a result, the reimbursement of the procedure. Make sure surgeons are aware of this small but significant distinction."
Set Up Your Spine Service Line for Success
Plan ahead and focus on slow, steady and deliberate growth.
Spine is one of the hottest specialties in outpatient surgery, but in order for your facility to provide high-quality accessible care, specialized equipment and instrumentation plus an astute awareness of the needs of your community are required.
The Surgery Center at Shrewsbury (Mass.), a 35,000-square-foot multispecialty center that opened in 2018, epitomizes this careful planning and consideration. Spine was on its radar from the start, but it took years for its leaders to activate the service line with confidence.
Its ORs, however, were built with the eventual addition of spine in mind. "Spine ORs should be roomy, but they don't need to be enormous," notes Prashanth Bala, MS, MHA, vice president of ASC operations at Shields Health Care Group and acting administrator at the Shrewsbury ASC. "At 520 square feet, each of our facility's nine ORs were built to be specialty-agnostic. They are large enough to accommodate total joints procedures, which we added right before the pandemic hit and with which we've experienced great success," he says.
Mr. Bala says it is key to get your spine surgeons on the same page and standardize as much equipment as possible before launch. "We were able to control costs by focusing first on purchasing equipment and supplies for specific procedures that all our surgeons would use, and then strategically adding to our fleet of table attachments as needed," says Mr. Bala.
A center adding spine will also need enough space to handle the many instrument trays and implants surgeons require. "Spine procedures typically involve five to seven trays in the room," says Mr. Bala. "A key for us was narrowing down exactly how much instrumentation our surgeons would need for a given case." After engaging his vendors to fine-tune supply purchasing processes, the center reduced the typical average of five to seven trays down to three to five. "This avoids overloading sterile processing while also saving storage space," adds Mr. Bala.
Before adding spine, Mr. Bala suggests paying close attention to your local and regional market. Are spine cases migrating to ASCs? "Our center remains one of only a few ASCs performing spine procedures in Massachusetts, so we have a responsibility to ensure that patients know it is no longer required that they get this type of care at a hospital, and that they'll receive the highest quality of care at our outpatient facility," he says.
Lab Test of VCF Procedures Finds BKP with Kyphon Assist™ Performed Best at Highest Loads
Cadaver study challenges competitive height restoration claims.
For treatment of vertebral compression fractures (VCFs), several studies support bilateral balloon kyphoplasty (BKP) vs. nonsurgical management and vertebroplasty for correcting kyphotic deformity/angle1,2 and restoring the height of the fractured vertebra2,3. Studies also have supported bilateral BKP vs. unilateral BKP for restoring vertebral height3,4.
A 2022 cadaver study5 also addressed the role of bilateral BKP in restoring height and correcting anatomical relationships in the injured spine. It showed that BKP using Medtronic’s Kyphon Assist™ 8-gauge directional cannula sustained less height loss at the highest stress loads tested than procedures using a titanium implantable vertebral augmentation device (TIVAD).
Medtronic supported this cadaver study, which compared how three different treatment methods perform in restoring height. The procedures tested were bilateral BKP, bilateral BKP with Kyphon Assist™, and TIVAD.
Balloon kyphoplasty is a minimally invasive surgical procedure for the treatment of spinal fractures due to osteoporosis, cancer or non-cancerous tumors.
Although the complication rate for BKP is low, as with most surgical procedures serious adverse events, some of which can be fatal, can occur including heart attack, cardiac arrest (heart stops beating), stroke and embolism (blood, fat or cement that migrates to the lungs or heart). Other risks include infection; leakage of bone cement into the muscle and tissue surrounding the spinal cord and nerve injury that can, in rare instances, cause paralysis; leakage of bone cement into the blood vessels resulting in damage to the blood vessels, lungs and/or heart.
The study, "Height restoration and sustainability using bilateral vertebral augmentation systems for vertebral compression fractures: a cadaveric study," was published online ahead of print publication in The Spine Journal. Here is how the study was designed:
- Osteoporotic spines from human cadavers were dissected into 30 two-functional spine units.
- Vertebral wedge compression fractures were created by reducing the anterior height of the vertebrae by 25%.
- Post-fracture surgery was performed on each spine unit, 10 each for BKP, BKP with Kyphon Assist™, and TIVAD.
- Post-surgery, cyclic loading was performed on each spine unit. Three different loads represented levels of activity including walking, standing up and sitting down, and lifting a 5-10 kg weight from the floor.
- Anterior, central and posterior heights were assessed based on fluoroscopic imaging and compared among treatment groups.
The three procedures performed similarly, producing at least 94% height restoration. At the highest loads tested, however, BKP with Kyphon Assist™ was best able to sustain height restoration, showing less height loss over time than BKP alone and TIVAD.
The cadaver study results challenge the 2019 SAKOS clinical study6, which aimed to support a non-inferiority finding for the use of Stryker's SpineJack™* TIVAD system compared to BKP. In this study, the analysis of primary endpoint on the ITT population demonstrated non-inferiority of the TIVAD to BKP. The analysis of the additional composite endpoint demonstrated the superiority of TIVAD over BKP (p<0.0001) at 6 months (88.1% vs. 60.9%) and at 12 months (79.7% vs. 59.3%) in height restoration.
There were, however, several limitations to the SAKOS study, with respect to height restoration:
- It leveraged less advanced Medtronic technology for the BKP arm with Gen 1 Xpander™ balloons (400psi). Improved Gen 2 balloons (700psi) were commercially available at the time of the study but were not used.
- The authors state, "Radiographic reviews were performed independently by experienced radiologists blinded to treatment." It is impossible to blind an experienced radiologist from the presence of a metallic device.
- The SAKOS study found statistically significant difference in height restoration only at midline. There was no statistically significant difference in anterior or posterior height restoration.
By measuring the performance of procedures using its most advanced balloons and directional instruments, the Medtronic-supported cadaver study further confirms the role of bilateral BKP in fracture reduction and height restoration for the management of vertebral compression fractures.
Learn more about the height restoration cadaver study: medtronic.com/heightstudy.
1. "Dohm M, Black CM, Dacre A, Tilman JB, Fueredi G on behalf of the KAVIAR investigators. A randomized trial comparing balloon kyphoplasty and avertebroplasty for vertebral compression fractures due to osteoporosis. Am J Neuroradiol. 2014;35:2227-2236."
2. Van Meirhaeghe JV, Bastian L, Boonen S, et al. A Randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures. Spine. 2013; 38(12): 971–983.
3. Bozkurt M, Kahilogullari G, Ozdemi M, et al. Comparative Analysis of Vertebroplasty and Kyphoplasty for Osteoporotic Vertebral Compression Fractures. Asian Spine J. 2014;8(1):27–34."
4. Cheng X, Long HQ, Xu JH, Huang YL, Li FB. Comparison of unilateral versus bilateral percutaneous kyphoplasty for the treatment of patients with osteoporosis vertebral compression fracture (OVCF): a systematic review and meta-analysis. Eur Spine J. 2016;25(11):3439-3449.
5. Holyoak DT, Andreshak TG, Hopkins TJ, et al. Height restoration and sustainability using bilateral vertebral augmentation systems for vertebral compression fractures: a cadaveric study. Spine J. 2022 Jun 23;S1529-9430(22)00274-1. doi: 10.1016/j.spinee.2022.06.011. Online ahead of print.
6. Noriega D, Marcia S, Theumann N, et al. A prospective, international, randomized, noninferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study). Spine J. 2019, 19(11). 1782-1795. doi: 10.1016/j.spinee.2019.07.009. Epub 2019 Jul 17. PMID: 31325625
© 2022 Medtronic. Medtronic, Medtronic logo and Engineering the extraordinary are trademarks of Medtronic. ™* Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.
Spine Robotics Under the Microscope
Literature review finds robotic assistance is promising from many angles but calls for more extensive research.
Robotic assistance can improve the precision of pedicle screw placement during spine procedures, although questions remain about technology's overall clinical benefit and economic payoff.
The authors of a literature review say intrapedicular accuracy with robotic assistance has proven to be either superior or equivalent to free-hand technique, while radiation exposure remains generally similar to free-hand with a trend toward lesser exposure as surgeons' experience with the robot increases. "Operative times, outcomes and complication rates have been variable between prospective and retrospective studies, with mostly equivalent results when compared with free-hand screw placement," they add.
The authors expect robotics in spine surgery to rapidly increase, with a caveat. "Although new technology is enticing, understanding its impact on healthcare quality is essential," they write. "Surgeons should understand the potential pitfalls that could lead to [pedicle screw] misplacement." These include cannula skiving, which can occur from soft tissue pressure or from enlarged, degenerative facet joints and hardware issues that may misplace the trajectory.
The authors say robotic assistance may be especially useful in cases of deformity or following placement of multiple interbody devices. In terms of economic benefits, surgeons and facilities should account for the learning curve associated with mastering robotic assistance. They add that more economic, biomechanical and clinical outcomes research is needed to quantify and qualify the benefit of robotic assistance for spine surgery. "With the drive for healthcare value becoming increasingly pertinent for reimbursement, the benefit of robotic assistance needs to be better analyzed in both the intraoperative costs, as well as its relation to patient-reported outcomes," they write.
The study, published in Techniques in Orthopaedics, concludes, "As with most new technology, a learning curve is apparent, with the potential for a decrease in radiation exposure and economic benefit over time." The authors say that understanding the potential benefits and pitfalls of robotic assistance is essential before investing in it.
Physician Ownership of Outpatient Spine Centers on the Rise
Surgeons who want greater control take on greater risk.
A survey of academic spine surgeons found that 49% of them had investments in freestanding ambulatory surgery centers (ASCs) in 2019. That number is likely larger now in conjunction with a general rise in physician-owned ASCs, which are expected to grow at annual compound rate of nearly 5% until 2024.
Those number should not be surprising, as spine surgery has steadily continued to migrate from inpatient hospitals to hospital outpatient departments (HOPDs) and ASCs. In 2009, for example, 81% of lumbar laminotomies were inpatient cases. A decade later, 68% were performed in HOPDs and 10% in ASCs, with only 22% remaining inpatient.
The survey, summarized and analyzed in Annals of Translational Medicine, also delved into ownership models, costs, safety issues and potential conflicts of interest surrounding physician ownership.
The two primary ownership models are independent ownership and joint ventures with hospitals, according to the analysis. Independent ownership provides surgeons with reimbursements in the form of facility fees and professional fees, along with increased control over staff and how the facility operates. Drawbacks of that model include the amount of cash needed to start an ASC, which could put a surgeon in debt and pose significant personal financial risk. The authors say partnering with hospitals instead could make it easier for some new spine centers to navigate complex regulatory hurdles, boost patient referrals and simplify negotiations with commercial payers and CMS. Further, such joint ventures share financial risk.
Costs to perform spine surgeries are lower for ASCs, but so are the reimbursements. The article references several studies that show outpatient spine procedures have low complication rates and few hospital transfers, but notes that some of this research has been called into question and says further studies are needed. Independent physician owners must be mindful of conflict-of-interest laws as they make clinical decisions that could determine how much they will gain financially from their cases, say the authors.
"Given the complexities and rapidly changing nature of the reimbursement and utilization related to ASCs, independent physician ownership remains a risky but potentially profitable business model for physicians," states the article. "Joint surgeon-hospital ventures offer mitigation of these risks, but the specifics of the arrangement with regard to reimbursement, ownership and management can dramatically affect the worthwhileness of such an arrangement."