Femtosecond Laser Cataract Surgery: Setting and Infrastructure

18 Femtosecond Laser Cataract Surgery: Setting and Infrastructure


Timothy V. Roberts



Summary


Laser cataract surgery is a new and different operation from manual surgery and requires a paradigm shift in thinking. This chapter examines the setting and infrastructure conducive to the optimal use of femtosecond laser cataract surgery. Among the topics discussed are the regulatory status and environment, issues relating to adoption of the technology, equipment acquisition and implementation issues, purchasing a system, the surgery suite, practice logistics, staff training, and marketing.


Keywords: FS lasers, cataract surgery, logistics, day surgery facilities, financing, ambulatory surgery centers


18.1 Introduction


Like many other areas in ophthalmology, cataract surgery has become increasingly complex, requiring more high-tech equipment and greater skills and precision to achieve a more predictable, safe, and reproducible procedure with correction of pre-existing astigmatism at time of surgery. Cataract patient expectations, especially those of the exploding “baby boomer” market, have increased dramatically, along with the complexity of surgical options. The baby boomers who drove the LASIK (laser-assisted in situ keratomileusis) market are now turning 65 years old and becoming the core of the cataract surgery market. This emerging baby boomer group is more accustomed to contributing to the cost of their health care than previous generations, and is highly motivated to access the best technologies available. These changing demographic factors provide a realistic framework for the introduction of laser cataract surgery (LCS).


The rapid evolution of femtosecond (FS) laser technology has had a disruptive effect driving greater expectations of a precise capsulotomy, small and precise incisions with laser-generated wound architecture, patient safety and reduced complication rates, improvement in other technologies related to cataract surgery such as new instrument tips optimized for less invasive lens extraction, and improved intraocular lens (IOL) performance via effective lens positioning. The potential for improved safety and increased precision of key steps in cataract surgery, combined with the increased equipment and infrastructure costs, have public health and economic implications for the health care system, physicians and patients, governments, health insurance organizations, and day surgery facilities. 1


Modern cataract surgery is a remarkably successful and life-changing procedure; however, the rate of postoperative residual refractive error remains a significant problem, and the procedure is not complication free. A paradigm shift has occurred with an understanding and expectation now that cataract surgery is refractive surgery, with postoperative uncorrected vision the yardstick for assessing “success.”


What are the public health implications of technology designed to improve surgical outcomes, safety, predictability, and refractive results? Small incremental improvements in attaining the target refraction are clinically relevant when considering the millions of patients undergoing surgery worldwide each year. A small overall improvement can lead to a large reduction in the refractive “surprises” at either end of the bell-shaped distribution, meaning many more of our patients will be free of glasses. Similarly small incremental improvements in safety are clinically relevant when considering the millions of patients undergoing surgery worldwide each year.


18.2 Clinical Practice and Diffusion of Technology


Cataract surgery is the most common ophthalmic procedure performed worldwide, with an estimated 19.5 million cataract procedures performed in the world in 2011. It is also one of the safest and most successful major surgical procedures performed worldwide. Over the last 50 years, there have been substantial developments in equipment, technology, and surgical techniques designed to improve patient safety and visual outcomes. Cataract patient expectations and the complexity of the surgical options have increased dramatically, especially since LASIK became popular. Baby boomers are expecting faster, safer, and more successful outcomes and surgeons will need to offer a comprehensive range of refractive options such as toric lenses, limbal and intrastromal relaxing incisions, and multifocal lenses, as well as having the related equipment including FS lasers, corneal imaging systems, and advanced biometers for axial length measurements.


Keeping at the cutting edge of medical practice is financially demanding; however, it is important for patient outcomes, professional reputation, and personal satisfaction to keep up with the latest technology. Practices ranging from small solo businesses to large groups must be willing to invest in the latest technology to ensure the best interests of our patients. Integrating FS LCS into a practice takes time and detailed training of all staff. Use of the laser and surgical techniques needs to be learned and different surgeons will have different learning curve experiences.


The major health economic issues of LCS are the economics (cost to the patient and day surgery), surgeon access to a laser, return on investment, impact on patient flow and procedure time, practice integration, and staff training. It is critical for the surgeons to be true believers in the technology and to communicate this enthusiasm and commitment to patients and staff. A pitfall to avoid is having doubts and uncertainties and not fully committing to the new technology once the ambulatory surgery center or hospital has purchased a laser system. This results in low utilization levels, stagnated learning curve, and delay in achieving clinical experience and confidence.


18.2.1 Regulatory Status and Environment


The regulatory environment impacting LCS varies significantly worldwide, and the availability and affordability of this technology will therefore vary in a similar fashion. In nearly all countries, access to LCS will require some patient co-payment to cover the additional cost. In the United States, for example, the approved use of the FS laser in cataract surgery is primarily for premium IOL use. Surgeons cannot charge patients unless they are undergoing a procedure in which an enhanced refractive outcome is being delivered, which involves the management of astigmatism and/or presbyopia. The average conversion rate in the United States is about 15% and it is projected that 360,000 procedures, or 9% of cataract surgery, will be performed in 2016 using femtosecond laser–assisted cataract surgery (FLACS). Other countries, such as Australia, allow for LCS to be offered to all patients, irrespective of a lifestyle-enhancing refractive goal, with a patient able to make a co-payment in addition to receiving government and private insurance reimbursement. In some European countries and New Zealand, health funds will not reimburse members for any costs associated with cataract surgery if the FS laser is used and the patient may have to completely opt out of their insurance plan.


18.2.2 Laser Cataract Surgery Penetration


There are several important issues relating to surgeons adopting LCS: practice economics and reimbursement, clinical data showing benefit, practice, and day surgery logistics, and procedure time. Technology continually evolves, and keeping up to date with the latest technology requires careful planning and resource allocation. Reimbursements in many countries are going down, and comprehensively equipping a practice can be costly.


Estimates of LCS penetration differ between Europe, North America, Australasia, and other regions. In Europe, access to LCS increased from 5% in 2011 to 10% in 2012 and 17% in 2013. Usage of the FS laser increased from 2% in 2011 to 7% in 2012 and 9% in 2013. In the United States, it is estimated that LCS accounts for about 17% of total cataract surgery volume and will rise to approximately 30% in 5 to 10 years. 2 In most cataract surgery practices, FS lasers are rapidly incorporated with increasing usage over the 6 months following installation as surgeon and patient familiarity with the technology grows. The penetration is likely to further increase if costs come down.


18.3 Equipment Acquisition and Implementation Issues


Cataract surgery worldwide is performed in surgeon-owned ambulatory surgery centers (ASC), corporate-owned ASC, hospital-owned ASC, or hospital operating rooms (ORs). In the United States, nearly 50% of cataract surgery is performed in surgeon-owned ASC. 3 The introduction of FLACS will necessarily require changes to the organization of cataract services, particularly logistic and payment issues. The logistics of performing the laser treatment in a room that is separate from the OR in the surgical suite where the remainder of the surgery is performed needs to be considered. Payment for the surgical procedure must be addressed in a financially sustainable way—will patients pay for all or part of the technology set-up and consumable costs?


One of the most important factors is to ensure that the surgeons who will use the laser are enthusiastic and supportive of transitioning to the new technology. Some surgeons in a group practice or hospital department may be keen to move to LCS and believe the advantages that LCS may offer make the added cost a value proposition, whereas others may be perfectly happy with their current results, and skeptical about the outcomes and having to learn a new surgical technique requiring a significant capital outlay. Low usage places financial pressure on the surgery facility, but more importantly results in surgeons never confidently transitioning through the learning curve. This in turn leads to a lack of confidence and low conversion rates, thereby perpetuating the problem. The decision to purchase a laser system, as well as agreement on which system to acquire, is best done with a 100% buy-in by the whole group of surgeons in the practice or hospital department. The entire doctor group needs to be enthusiastic about the quality and capabilities of the machine, and committed to using it, regardless of the cost. If the doctors are not excited about the machine, they will not use it as often.


Given the cost of the technology, the economics and business modeling will be challenging for a single surgeon surgical center, unless it is a high-volume center. It is likely to be more feasible for an individual laser system to support multiple surgeons and ORs. Depending on the local reimbursement rate and capacity for patient co-payments, an institution, whether it is an ambulatory surgical center, a private hospital, or indeed a public hospital, would need to be doing approximately 500 cataract procedures per year to justify the instillation of this technology. If the technology evolves and more competition enters the market, FS lasers may be applicable in smaller centers doing, say, 200 to 300 cases per year; however, these centers may struggle developing a realistic business model. The business plan must include assumptions regarding forecast conversion to laser procedures. Once this is established, costs are determined including labor, medical supplies, capital cost of the laser system, and service contract. These are then used to work backward to determine the procedure fee for the patient.


18.3.1 Purchasing a Femtosecond Laser System


Purchasing an FS laser cataract system is a major capital investment. This may be funded and owned by a single physician or a group of physicians, hospital and day surgery providers, or third-party providers. Prior to purchasing a laser system, it is helpful for representatives of the surgeon group and hospital/surgery center to visit a practice that has successfully implemented LCS. They can observe the different stages of the patient journey through LCS from patient counseling and booking by the staff, admission and the actual surgical procedure, and the postoperative outcome and patient experience. This will give the surgeons and surgery center managers technical and logistic insight, exposure to different laser systems, as well as enthusiasm that this cutting-edge technology will ensure their practices continue to be market leaders for cataract surgery.


Options to acquire or use a system include (1) purchase outright, (2) pay per procedure, (3) rental arrangement, or (4) purchase and cross-merchandising agreements (CMA). The billing structure will vary from country to country depending on the regulatory environment and the business model for purchasing or accessing the laser. In some facilities, the surgeon bills the patient for the FS laser and is then charged a facility fee by the day surgery facility (DSF) for the use of the laser. In other facilities, the DSF bills the patient directly independent of the surgeon fee. A CMA is a common way for vendors to secure new capital business without the company having to expend its capital budget. Effectively, the new equipment is paid off over a set period of time by levying a premium on consumable products. Advantages for the DSF include no capital outlay (with the exception of an agreed deposit deposit), no interest charges, guaranteed service coverage, included updates as technology progresses, and a locked-in service price over a set period, usually 3 to 5 years. Advantages for the vendor include a guaranteed set period whereby the DSF uses prescribed consumables with a premium paid on consumables.


Another model is partnering with companies that offer mobile access to the FS laser. These companies bring the FS laser to the DSF or hospital-based OR and set it up, typically the night before the surgery day. The company provides experienced technicians who calibrate the laser and remain in the surgery center with the surgeon for the duration of the list. Having an experienced technician is particularly beneficial for the surgeon transitioning to this new technology (▶ Fig. 18.1).



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Fig. 18.1 Patient positioned on LenSx in laser procedure room.

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Feb 23, 2020 | Posted by in OPHTHALMOLOGY | Comments Off on Femtosecond Laser Cataract Surgery: Setting and Infrastructure

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