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January 05, 2022
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Office-based surgery, ASCs have evolving role in ophthalmology

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Over the years, Daniel S. Durrie, MD, has been through several eras of transition. In his early years as a surgeon, nearly all cataract surgeries were done in a hospital setting.

“When I was doing surgery in the hospital, we were keeping patients there for 3 or 4 days,” he said. “I was one of the first people to start doing outpatient cataract surgery in 1979 at the hospital and first to do surgery in ambulatory surgical centers in the ’80s and ’90s. Even back then, there was a lot of discussion of where that was going.”

Jason P. Brinton
In certain cases, office-based surgery can be "more appropriate and also safer" than surgery in an ASC or hospital, according to Jason P. Brinton, MD.

Source: Darin Hartlieb

Now, ASCs are an everyday part of ophthalmic surgery, and the discussion has moved to the practice of office-based surgery (OBS). Even as the topic remains controversial, more ophthalmologists are investing in office-based suites. In 2019, there were about 100 in the United States.

“It’s not like it’s the majority at all,” Durrie, OSN Refractive Surgery Editor Emeritus, said. “There are almost 1,000 ophthalmic-specific ASCs out there, which will continue to grow as well. Both of them are viable options. For doctors who are in a transition, experiencing practice growth or opening up a satellite office, office-based surgery is a viable option that they should consider.”

Lance Kugler
Lance Kugler

As the number of OBS suites grows, advocates have faced questions about patient safety and experience, as well as concerns about reimbursement. However, Lance Kugler, MD, said in his experience, OBS has presented an opportunity for all parties involved.

“It’s a unique situation that doesn’t happen very often in medicine,” he said. “You have a change happening that benefits the patients, the surgeons and the payers. When all three of these things align, you’ve got something. It helps all three in complementary ways.”

Safety

Many in the ophthalmic community have serious concerns about safety in an OBS setting. Cathleen M. McCabe, MD, said that a lot of those concerns are related to patient selection, accreditation and oversight, and requirements for anesthesia.

“Cataract patients are older, and 88% have two or more comorbidities. In August 2015, Outpatient Ophthalmic Surgery Society (OOSS) in cooperation with Association of Ambulatory Surgery Centers and the Society for Excellence in Eyecare engaged 170 ophthalmic-driven ASCs in a comorbidity study to randomly sample the health and physical examination records of 50 of their most recent cataract patient cases. The sampling totaled 8,500 cases, representing a total annual case volume of more than 400,000 cataract patient cases, or 13% of the total of all estimated cataract cases performed in the U.S. Of the patients included, 55% were 70+, 16% were 80+ and only 12% were younger than 60 years of age,” McCabe said. “Eighty-eight percent of patients presented two or more comorbidity conditions, including hypertension, cerebrovascular disease, pulmonary disease, endocrine disease or cancer. Only 6% of cataract cases had no comorbidities. Additionally, most patients were taking multiple prescription medication.”

Cathleen M. McCabe, MD
Cathleen M. McCabe

McCabe, president of the Outpatient Ophthalmic Surgical Society, a 40-year old advocacy group for ophthalmic ASCs, said there is always a risk that unforeseen complications might arise during surgery.

“There are settings where elective surgeries in younger patients can be done safely without intravenous sedation without an anesthesiologist or nurse anesthetist present, but it’s such a small percentage of what ophthalmologists actually do,” she said. “In an ASC, titrated anesthesia is administered and monitored by an anesthesiologist or CRNA to meet the patient’s needs. OBS anesthesia is limited to light oral sedation administered by an RN. The surgeon assumes responsibility for life safety code administration. What I worry about is that there could be pressure to take patients who are marginal and bring them into a setting that maybe isn’t optimal for their safety.”

In February 2015, Healio/OSN Board Member Jason P. Brinton, MD, became the first U.S. surgeon to switch his practice to OBS. In nearly 7 years of experience, Brinton has come to believe that OBS has its own safety benefits, especially when the surgeon is careful with patient selection.

“This discussion is not about sick patients,” he said. “It’s about whether younger and healthier patients having refractive lens exchange, refractive cataract and even some retina procedures now can be better served in an office surgery setting as opposed to the traditional ASC/hospital setting. In many cases, I believe OBS can be both more appropriate and also safer.”

Brinton said OBS better facilitates the physician working with the same staff for both clinic and surgery. Training on customer service and patient safety can be performed in an integrated manner for the team.

“How many times have you heard a colleague say that they wished their ASC staff provided the same level of care and customer service as their clinic staff? OBS allows the surgeon-owner to exercise greater quality control over the process using established safety standards and industry best practices,” he said.

In a study published in Ophthalmology in 2016, researchers looked at postoperative visual acuity and adverse events among more than 13,000 patients who underwent elective OBS at Kaiser medical facilities. Along with visual outcomes consistent with those found in ASCs and hospitals, researchers found overall low rates of adverse events, which included capsular tear (0.55%), vitreous loss (0.34%), iritis (1.53%), corneal edema (0.53%) and retinal tear or detachment (0.14%). Only 0.7% of eyes needed second surgeries within 6 months, and no life- or vision-threatening adverse events were reported.

With safety being so high in an OBS setting, particularly among healthy patients, Brinton said other aspects of an ASC create distractions for surgeons.

“In the office surgery setting, you can focus on meeting and exceeding proven ophthalmic patient safety standards rather than diversions such as staff drills on how to bag and evacuate an intubated general anesthesia patient during a fire,” he said.

Assigning an anesthesia provider to each case can be a double-edged sword for some patients, Brinton said.

“As practitioners, we seek to provide the optimal amount of sedation, and too much can be just as concerning, if not more so, than too little. In a hospital/ASC setting, with an IV in place and CRNA in the room, patients are more likely to get sedative medications that are not needed. In office-based surgery, of necessity, the team learns to be adept at providing a relaxing environment with music, hand holding and conversing with the patient, what we call vocal local,” he said.

Kugler said some people misunderstand what an OBS even is.

“They kind of picture it as just being some procedure room,” he said. “This is a full operating room no different than what you would find in an ASC. It’s not a difference in facility — it’s a difference in paperwork. What’s often lost on people is that it is a full OR, but in fact, it can be even better for our purposes because it was built entirely for eyes.”

Patient experience

Kugler had good experiences in ASCs, but he started making changes in 2017 when he observed some differences between patients he saw in an ASC for intraocular surgery and patients he saw in his office for LASIK procedures.

“Although the ASC provided a nice patient experience, it wasn’t the same kind of experience that our LASIK patients were having,” he said. “We started doing OBS on patients needing RLE and ICL, and over time, our OBS services grew into refractive cataract surgery as well.”

Having a suite for OBS gives physicians an extra layer of control for patient experiences, Luke Rebenitsch, MD, said. When he first started doing procedures in the office, he was not expecting patients to accept it right away.

“We thought patients would prefer to have an IV or have more anesthesia,” he said. “But we can control the whole experience. We can control the type of preop beds patients are in. We have massage chairs and music. If anything, our patients have loved it. We have not had a single complaint.”

Luke Rebenitsch, MD
Luke Rebenitsch

The surgical process is more streamlined for patients undergoing OBS procedures, Kugler said. An easier check-in routine, familiar staff and a more relaxed environment all help put patients at ease, he said. Removing the need for additional anesthesia services also streamlines the billing process.

“What we’ve learned since we’ve had our own center is that you’re introducing anxiety when you bring a patient to a third-party center,” he said. “When we bring them in here, they know the staff, they don’t require an IV, and they’re not putting a gown on. It’s a much calmer scenario, and generally, they’re much happier.”

Brinton said OBS has changed the patient experience by removing outside stressors that are unrelated to ophthalmic surgery. Because ASCs are often used by multiple specialties, situations may occur that could scare patients before their own surgery.

“During the final weeks at our ASC in February 2015, one of my refractive cataract patients had an anxiety-provoking experience. As the previous patient was rolled out of the OR, he had a bandage around his head and neck area and made an audible moaning-type sound,” he said. “Our first patient, who was waiting to go back to surgery, noticed this. It was upsetting and anxiety-provoking.”

When Brinton’s patient returned for his second eye surgery 2 weeks later, the surgery was performed in their office suite.

“In the end, my patient had two entirely different surgeries, at least in his view,” Brinton said. “The first one was like having major surgery; in the second, his experience was comparable to what he heard from his friend who had LASIK in our office and referred him to our practice.”

McCabe said she designs her patients’ experience at the ASC to be consistent with how they are treated at the clinic. She said that the vast majority of cataract patient are treated in single-specialty, ophthalmic-driven ASCs where patients rarely encounter emergent and unsettling situations.

When patients are more complicated or have comorbidities, an ASC is always an option, Rebenitsch said.

“ASCs are great in certain cases, especially when it comes to patients who may need greater anesthesia,” he said. “In rare cases where a patient may be less stable, I will still go to a hospital or ASC and offer traditional anesthesia. However, the vast majority of patients coming through for cataract surgery don’t need that, and frankly, it’s probably safer without for most.”

Surgeon pros and cons

When Kugler’s surgical center shut down for elective procedures at the start of the COVID-19 pandemic, the extra control associated with his OBS made the process of rescheduling patients more streamlined. Control has been a major selling point for OBS.

“You control your own center — the equipment, the processes, the protocols, the staff. Everything can be geared around a smaller group of people,” Kugler said. “When we reopened, we were able to minimize the number of people that were in the office at a certain time. We were able to control a number of variables in a way a third party couldn’t do for us.”

While lower costs and scheduling control might be attractive for providers, as well as some payers, McCabe said they are not always patient-centric considerations.

“Simply stated, an OBS facility is not an ASC. For OBS to be adopted by CMS for facility reimbursement or accreditation by the Accreditation Association for Ambulatory Health Care, OBS facilities will be required to meet substantially more rigorous patient health and safety standards governing anesthesia, backup power and staffing, to name a few. We do not believe that facility payment by Medicare is on the near- or longer-term horizon. In its updated cataract Preferred Practice Pattern guidelines issued in November 2021, the AAO stated: ‘The next opportunity for major changes such as this will occur in about five years under the current schedule for review of cataract payment under Medicare,’” McCabe said. “OOSS’ Washington counsel Michael Romansky believes that implementation of facility payment for office cataract surgery is many years off. Moreover, many believe that the OBS model is simply not economically viable. A consideration for physicians exploring an OBS solution is whether they believe they can secure local payer contracts because Medicare is not expected in the foreseeable future, and local contracts are very challenging to negotiate. Frankly, we are skeptical of the economic viability of the OBS model.”

Brinton said a primary obstacle to wider adoption of OBS is the reimbursement environment.

“Reimbursement for OBS is the elephant in the room,” he said.

“As an organization, it’s important to be able to keep our centers equipped with the best technology and be able to constantly improve it,” McCabe said. “To do that, you have to have a viable business entity. If you’re not in the best position financially because of reimbursement issues, it makes it more difficult to stay on the cutting edge and offer the best care.”

However, Brinton believes it is only a matter of time before Medicare and CMS are on board with OBS.

“CMS pays careful attention to our frequently performed procedures,” he said. “It’s no secret that the hospital OR is a less-than-efficient setting in which to perform the hundreds of thousands of cataract surgeries that are performed yearly on younger, healthier patients. It’s only a matter of time before the same reality becomes clear relative to our ASCs.”

Daniel S. Durrie
Daniel S. Durrie

Durrie said a lot of the reimbursement issues are due to the newness of OBS, and payers will need a better understanding of it before the process is streamlined. He said the situation is identical to what went on with ASCs when they first started gaining popularity in the medical world. Durrie is the chairman of iOR Partners, a company that works with ophthalmology practices to navigate building and operating an OBS suite.

“It’s probably going to be a new thing for each of the payers in your region,” he said. “We work with practices and help them with the different processes. It will be different between practices, payers and regions. Medicare is different than commercial insurance, and that is different than private pay. All of these buckets need to be addressed, but even now it’s easier to navigate than it was before.”

In 10 years, Brinton said the debate about OBS will not be much of a debate at all.

“The previous generation of ophthalmologists made the move from the hospital to the ASC. For our generation, the move will be to office-based surgery,” he said. “These changes take time, but it will happen.”

Durrie expects all three settings — hospitals, ASCs and OBS suites — to remain important parts of ophthalmic surgery.

“These major changes to important services shouldn’t happen overnight, and no matter what, these surgeries need to be done in accredited centers,” he said. “But 10 years from now, I would think that about 40% of ophthalmic surgery will probably be done in an office setting. If you follow the trends, you can see that there is a lot of practicality to doing it in the office.”

Recognizing that OBS is a new, unproven business model banking on Medicare and payer adoption in the future, McCabe urged extreme caution to any practice looking to jump into the OBS trend.

“I’d look at the business model and make sure that what’s being promised as far as reimbursement is an actual reality in their state,” she said. “If you are considering building an office-based surgery center, I would look at the requirements for safety at an ASC, and I would actually build to those requirements. If it turns out that expectations don’t pan out, there is the possibility of getting your center certified as an ASC. I would also urge you to model actual reimbursement rates and your patient mix to determine viability of your investment. In its simplest and fact-based evaluation, in an ASC, 45% to 50% of your patients will have Medicare coverage for which your facility fee is $1,200 while it’s $0 in an OBS. The only approved reimbursement code in OBS is the $150 to $160 for the IOL. I would be cautious with any other billing practices; consulting a billing and coding expert would be a good investment as you vet the OBS model for your practice.”

Jeffrey Whitman, MD
Jeffrey Whitman

OSN Cataract Surgery Board Member Jeffrey Whitman, MD, OOSS chairperson of government affairs, said, “Presently and for the foreseeable future, OBS will continue to be a small, niche solution for physicians who want to integrate a surgical suite in their office, are confident that they can deliver a safe patient experience, don’t have access to an ASC and are willing to forgo facility fees from Medicare. For most physicians, ASC ownership is an investment in an asset that will likely drive your current and future wealth.”

Kugler said when a practice is making these decisions, it is important not to reinvent the wheel.

“There’s a lot of resources now that I didn’t have when I was going through this process,” he said. “There’s a whole community around this now to help move this forward. I would encourage you to visit a center and see how it works.”

Click here to read the Point/Counter to this Cover Story.