To some surgeons, cataract surgery is a victim of its own success. The worry is that since many cataract cases can be performed in about 12 minutes or so, and still yield excellent outcomes, regulators and payors will view them as a routine procedures and devalue the surgical intensity and skill involved. Other surgeons, however, note the procedure’s sophistication, speed and generally good outcomes and see them as signs that the procedure can now be done in different venues, such as the ophthalmologists’ office, free of unnecessary regulations that don’t really apply to the modern cataract procedure. It’s against this backdrop that the Centers for Medicare & Medicaid
Services has begun mulling the possibility of reimbursing surgeons for in-office cataract surgery.

In this article, ophthalmic surgeons and their professional societies share their views on, and experiences with, in-office cataract surgery.

CMS’s Proposal

In a July 2015 proposal to provide special reimbursement for in-office cataract surgery, CMS mused that the time may be right for the modality, and requested comments from interested parties. Organizations such as the American Academy of Ophthalmology and the Ophthalmic Outpatient Surgery Society made sure their voices were heard, and called for more analysis.

The upshot of the CMS proposal is that cataract surgery usually uses local or topical/intracameral anesthesia, and has advanced to the point that it’s not only quick but also yields very good outcomes. “We believe that it is now possible for cataract surgery to be furnished in an in-office surgical suite, especially for routine cases,” the proposal states. CMS says the benefits of in-office surgery are convenience for the patient and doctor, and that, “ … furnishing cataract surgery in the non-facility setting could result in lower Medicare expenditures for cataract surgery if the non-facility payment rate were lower than the sum of the [physician fee schedule] facility payment rate and the payment to either the ASC or hospital outpatient department.”

After reading CMS’s proposal, ophthalmic organizations began to work together to try to present a rational approach for in-office surgery to the agency. Bloomington, Minn., surgeon and president of the Outpatient Ophthalmic Surgery Society, Y. Ralph Chu, says, in effect, the devil will be in the details when it comes to CMS determining what a properly equipped in-office suite will look like. “It’s not just transitioning surgery into an in-office surgery suite which, right now, is very unregulated,” he says. “Cataract surgery is a success story because it is performed in a highly regulated setting. We have serious reservations about whether an office-based surgical suite can deliver current outcomes and ensure patient health and safety. The ASC environment encompasses state-of-the-art equipment, instruments, systems and protocols; as well as surgeons, anesthesia professionals, and clinical staff trained in the special needs of ophthalmic patients and capable of addressing emergent needs. There is essentially no regulation of office surgical facilities by the feds or the states.”

Michael Repka, MD, medical director of government affairs for the American Academy of Ophthalmology, says the AAO also sees the need for more clarity before jumping onboard with the proposal. “How do we certify the office surgical suites?” he muses. “It’s not clear how we would make sure they’re safe enough for this procedure. You’d probably want to study it in some way to understand that. It’s difficult for a spokesman to say ‘regulation is good,’ but maybe there is some level of regulation that would be appropriate in order to avoid the patient getting substandard care.”

Surgeons at SightTrust Eye Institute in Sunrise, Fla., built an in-office cataract surgery suite that features a five-bay post-anesthesia care unit. (All images: Andrew Shatz, MD)
Learning from Experience

For years, the discussion about the right way to perform in-office cataract surgery was academic, but now there are several ophthalmology practices actually performing in-office cataract procedures on a regular basis. It’s possible that ophthalmic surgeons can use these practices’ experiences as rough guides regarding the possible pros and cons of in-office surgery.

Kent Stiverson, MD, of Lakewood, Colo., is an ophthalmologist in the Kaiser Permanente Health system. Kaiser is a Medicare Advantage provider, which means the health system is capitated, and is paid a flat fee up front each month for a patient’s diagnosis, no matter what treatments or exams Kaiser’s physicians perform. In such an instance, since you’re being paid a set amount per patient, it pays to be as efficient as possible, and Dr. Stiverson says, in his experience, in-office cataract surgery allowed Kaiser to provide good care without the large initial investment and overhead involved with a certified ASC. He and his colleagues have now performed 44,000 in-office cataract cases, which, he’s quick to note, haven’t resulted in even one case of endophthalmitis. What’s more, he and his colleagues published an article on their outcomes from 21,501 in-office surgeries (performed between 2011 and 2014 in three offices) in the April 2016 issue of Ophthalmology, shedding light on how they made it work in case a surgeon were considering it for his practice.

Dr. Stiverson’s study describes the surgical setup in the three office minor procedures rooms: There are two advanced cardiac life support-certified registered nurses (one circulating and one monitoring/charting) and a tech assisting. There is no anesthesiologist, and no IV lines or injections are routinely used. Only topical anesthesia, with occasional intracameral anesthesia, is administered, sometimes accompanied by oral triazolam.1

In terms of results, postop mean best-corrected visual acuity was a little less than 20/25. Intraoperative adverse events included capsular tears (n: 119, 0.55 percent) and vitreous loss (n: 73, 0.34 percent). Postop AEs included iritis (n: 330, 1.53 percent), corneal edema (n: 110, 0.53 percent) and retinal tear or detachment (n: 30, 0.14 percent). Repeat surgeries were performed in 0.70 percent of the eyes in the first six months postop. Dr. Stiverson says, though it’s in-office surgery, it’s not some dank back room. “It might conjure up the image that you’ll just go to your exam room next door and start removing cataracts,” he says. “We would reject that completely. Our minor procedures rooms are nicer than most people’s [Medicare-certified] centers.” Dr. Stiverson adds, however, that not all Kaiser’s ophthalmic surgeons operate in the in-office suites. “We did have a couple of doctors who weren’t comfortable if they didn’t have an anesthesiologist with them,” he says.

While Dr. Stiverson was doing Medicare cataracts in their offices, two surgeons in Florida were using their in-office suite to perform elective premium cataract surgery.

Andrew Shatz, MD, and his partner Cory Lessner, MD, at SightTrust Eye Institute in Sunrise, Fla., built their in-office suite because the square footage they had for a two-OR setup didn’t meet Medicare certification for an ASC.
They also wanted to shift their practice away from Medicare-reimbursed procedures and toward fee-for-service, premium cataract surgery. Their in-office suite, which they built from the ground up, consists of two ORs and a post-anesthesia care unit.

The specifications SightTrust used for their in-office OR show how the concept of in-office surgery is still in flux. While there is no governing body that certifies in-office surgical rooms, making it possible in some states to build one to the standards that a surgeon feels are proper (as Kaiser did), a practice can also pursue certification by the Accreditation Association for Ambulatory Health Care, which was the path taken by SightTrust. Certification by AAAHC has a reputation as being strict and expensive, since there are more regulations to follow and physical plant changes to implement, but some surgeons like the extra layer of protection the certification implies. “We got certification by AAAHC, and follow all the strict standards imposed by Medicare for safety reasons more than anything else,” Dr. Shatz explains. “We hired a nurse administrator to oversee everything, and we bring in another RN and two anesthesiologists on surgical days. The rest of our staff is from the clinic side who are trained in surgical assistance.”

Questions at Issue

When the topic of in-office surgery comes up, certain aspects of it become the focal points of criticism. Here’s a look at the consensus of organized ophthalmology on these issues, as well as how they’re being dealt with at existing in-office ORs.

Surgeons say in-office cataract surgery suites, when built properly, can resemble ambulatory surgery centers.
 • Anesthesia. The CMS proposal somewhat minimizes the anesthesia that patients get in most modern cataract surgery cases, implying that intravenous sedation isn’t really necessary. “CMS missed an entire component of patient management which, for many elderly patients and patients in general, does include some sedation beyond the topical drops,” says Dr. Repka. “I would think that, for most, it’s far more comfortable to have surgery with sedation, and it’s probably safer. You never know when things are going to go badly.”

Dr. Stiverson says, in his experience and as shown by his study, minimal or no sedation works well. “We have no interest in igniting a debate between in-office surgery vs. ASCs, and I’d note that Kaiser also has certified ASCs,” he says. “But currently we’ve had fewer postop issues, including fewer falls, than in the ASC because people aren’t as sedated as they used to be. We actually had more hospital admissions when we were operating in a certified environment than when we went to the office environment. Now, a lot of our patients either get no sedation or a little triazolam.”

Dr. Shatz agrees that cataract surgery can be done without IV sedation if patients are well-prepped, but, he adds: “I really believe non-IV sedation increases risk. You don’t know how uncomfortable a patient is, and there’s more sensation in the eye than one would think; even with injecting 1% lidocaine you’re not deadening everything. There’s a pressure sensation and light and shadows a patient doesn’t understand.” He says he uses IV sedation in around 95 percent of his patients.

 • Infection control. In-office surgeons say certified Medicare ASCs have to abide by certain regulations that are expensive and unnecessary for performing cataract surgery effectively, such as firewalls built to last multiple hours, mandatory overhangs over exit doors, interpreters, laboratory service agreements and mountains of logbooks that need to be maintained. What these surgeons don’t scrimp on is infection control. Boulder, Colo., ophthalmologist Mark Packer, who co-authored the Kaiser study, says the safeguards don’t need to break the bank. “You need a clean room,” he says. “This is a separate room, usually connected to the OR, that has sterilization facilities. It should have an autoclave, and a separation between the dirty side and the clean such as a wall or plastic partition. On one side are the dirty instruments with facilities to wash and sterilize them. From there, they’re put on the clean side. There are also ventilation requirements in the OR and clean rooms to avoid negative pressure that could suck contaminants in.”

Dr. Stiverson says Kaiser’s minor procedures rooms take infection control seriously. “We don’t flash sterilize anything,” he says. “When I operate, I do 22 cases in half a day, and have 25 separate cataract trays. Everything gets full-cycle sterilization. Once a month, we have the ORs swabbed to check for contamination, just as they do it in a hospital or ASC. There are also positive air exchangers in the OR.”

Dr. Chu says, however, that deeming certain regulations as unnecessary might be shortsighted. “I’m not sure what is unnecessary.” Dr. Chu says. “The Medicare ASC conditions for coverage include rigorous standards for infection control, environment, Life Safety and anesthesia. There are no such detailed standards for office surgical suites in any specialty and CMS doesn’t appear to be interested in developing them.”

 • Patient comorbidities. OOSS believes cataract patients have more comorbidities than CMS seems to believe, and Dr. Chu says OOSS is surveying its members on this and sharing its findings with CMS. The idea is that this has a direct impact on characterizing most cataract cases as “routine.” Specifically, in a 2015 OOSS survey of 170 ophthalmic ASCs cited in OOSS’s response to the CMS proposal, only 6 percent of the cataract patients presented with no comorbidities (which included hypertension, cardiovascular disease, pulmonary disease and cancer). Eighty-eight percent of the patients had two or more. The organization believes these stats should be taken into account when and if CMS determines what safeguards an in-office OR needs. Along these lines, one aspect of the Kaiser paper that stood out was that two of the in-office suites were connected to a hospital, and the third was a little less than a mile away from a hospital. “The Kaiser facilities are located in larger settings proximate to emergency care and meet institutional standards for staffing, infection control and physical plant, to name a few,” Dr. Chu says.

“Independent ophthalmic practices that elect to perform cataract surgery aren’t presently subject to any of these requirements.”

Dr. Packer says there is a spectrum of comorbidities that can accompany a cataract surgery case that presents to an ophthalmologist, and in-office centers would have to do the cases they’re comfortable with. “A lot of the risk if the patient is sick with chronic obstructive pulmonary disease, diabetes or coronary artery disease actually comes from the IV sedation,” he says. “The surgery itself isn’t a huge impact on someone, even if he isn’t in tip-top shape. But there is a spectrum, and I think everyone could draw a line at his own comfort level. For the high-risk cases, there will always be a hospital.”
Financial issues. Though patient safety is foremost in everyone’s mind, questions swirl regarding the economic impact of shifting procedures into the office. Dr. Packer says this shift might be worrisome to ASC owners. “In-office cataract surgery looks interesting to Medicare if an office can achieve the same safety and effectiveness as an ASC without having to pay for such things as anesthesia services, for example,” says Dr. Packer. “Of the facility fee Medicare pays to an ASC for cataract surgery, which is roughly $1,000, $150 of it is for the IOL and the rest is for everything else, such as the numerous employees, firewalls, bigger parking lots, et cetera. It’s very expensive. In the office, there’s some overhead, but it’s much less than an ASC. So Medicare is thinking if the surgery can be done safely in the office, maybe it doesn’t need to pay the $1,000 facility fee anymore. The amount it will pay is the question, though.

So, if I own an ASC, all of this worries me,” Dr. Packer continues. “Because now there’s pressure from both sides: Physicians and patients enjoy the convenience of in-office surgery and the group paying for it is saying, ‘Patients and surgeons like it and I can get it for less.’ ” The one consolation for ASC owners is, currently, surgeons who operate in the office only receive a surgeon fee from CMS, roughly $750—$150 of which is for the IOL—and no facility fee, so Dr. Packer says this would be a “very tough breakeven point” to just do Medicare cataracts in the office. However, if a surgeon can build a premium in-office IOL practice, in which he gets $3,000 to $5,000 per eye, the numbers work.

Dr. Repka says there’s another reimbursement concern. “CMS could lower the reimbursement for in-office cataract to a point where it wouldn’t be reasonable to do the service there, but surgeons could get forced to do it that way,” he says. “That has to actually come down to an arcane payment policy called the indirect expense for an office vs. a certified facility. The infrastructure you need for a clinical exam in your office, for example, might be less than what you need to run an in-office surgery suite, but CMS might keep the indirect expense for both services exactly the same. It would be inappropriate if CMS were to use the same indirect expense value for both services.”

Dr. Chu says OOSS recognizes that its members have a significant investment in their surgery centers, but says that’s not what drives OOSS. “It’s not about trying to increase the level of regulations on in-office surgery just to protect our investment,” he says. “What it’s about is if surgery starts happening in different environments, and the outcomes aren’t the same as those in ASCs or hospitals, it gives the whole industry a black eye. My sense from the membership is that protecting how much money they’ve put into their surgery centers isn’t the first, second or even third argument they’re making about the issue. The sense I get is it’s really about patient safety.”

1. Ianchulev T, Litoff D, Ellinger D, Stiverson K, Packer M. Office-based cataract surgery: Population health outcomes study of more than 21,000 cases in the United States. Ophthalmology 2016;123:4:723-8.