For almost a decade, the ophthalmology community has debated the merits of office-based surgery (OBS) for cataracts and other eye conditions. Its proponents say OBS is safe, convenient, and often less expensive for patients. Opponents, meanwhile, maintain that more widespread, peer-reviewed studies are needed to prove the safety of OBS.
For the second time in seven years, the Centers for Medicare and Medicaid Services (CMS) has agreed with those who express concerns about the safety of office-based surgery. In a decision rendered in November 2022, CMS rejected a proposal to implement facility payments for office-based cataract procedures and other ophthalmic surgeries.
The Outpatient Ophthalmic Surgery Society (OOSS) applauded the decision, calling it “a victory for our patients and our ASCs” against commercial developers and promoters of office-based surgery suites. Other groups that came out against OBS include the American Academy of Ophthalmology (AAO), American Society of Cataract and Refractive Surgery (ASCRS), American Society of Retina Specialists (ASRS), and the Ambulatory Surgery Center Association (ASCA).
Supporters of OBS, meanwhile, expressed their disappointment.
“I think it’s a shortsighted decision,” says Ivan Mac, MD, founder of Metrolina Eye Associates, who operates an OBS at his practice in Matthews, North Carolina. “It’s something new, it’s innovative, and it’s different. I just don’t think there’s been enough time where [CMS] felt comfortable agreeing to do it. They didn’t say they’ll never do it, but they said they want to look at more data.”
Irfan Ansari, MD, an ophthalmologist who performs some procedures in an office suite while also operating in a separate ASC at his Kentucky-based Bluegrass Eyecare Center, agreed. “I’m a little disappointed, if you want to use that word, but it’s not entirely unexpected,” said Dr. Ansari. “And my understanding from what CMS said is that yes, they did reject the idea, but they left the door open to further discussion. It’s not a total loss by any means.”
Patient Safety Is the Primary Issue
CMS first considered making facility payments to ophthalmologists for eye surgery performed in an office-based suite, rather than an ASC or hospital, in 2015. After investigating the issue, the agency declined to move forward at that time, citing concerns relating to infection risk, anesthesia, equipment, management of complications, staff experience, and a lack of peer-reviewed study data supporting OBS safety. CMS cited similar reasons in its latest decision.
“CMS’s ruling [on office-based surgery] reflects the concerns of OOSS and all the major ophthalmology organizations that cataract, retina, and glaucoma patients are vulnerable and should be treated in an appropriately regulated environment like the ASC or hospital outpatient department,” said Jeffrey Whitman, MD, the chairman of government affairs for OOSS. “Our patients are typically older and present with multiple comorbidities. Virtually all ASCs are Medicare-certified, state licensed and accredited, and meet rigorous standards for infection control, facilities and environment and equipment, life safety, quality of care, and anesthesia, to name a few. Regulation of [in-office] surgical facilities at the state level is nonexistent at worst and inadequate and inconsistent at best. CMS’s ruling reflects the view that, to ensure patient health and safety, any facility that is conducting sterile intraocular procedures should be required to meet the same standards as those required for Medicare certification.”
For their part, Drs. Ansari and Mac believe that sufficient evidence already exists for the safety of OBS in cataract and certain other conditions such as glaucoma. They point to peer-reviewed research, such as a 2016 study of 13,500 patients who underwent elective cataract surgery in the minor procedure rooms at Kaiser Permanente Colorado–affiliated healthcare centers.1 The study, which covered procedures performed between 2011 and 2014, concluded that “[o]ffice-based efficacy outcomes were consistently excellent, with a safety profile expected of minimally invasive cataract procedures performed in ASCs and HOPDs.”
Dr. Ansari says his experience with OBS mirrors the results of the Kaiser Permanente study. “I’ve been doing office-based surgery for two years,” he says. “We’ve done over 1,500 cases. We have not had a single infection, and we’ve not had any of those concerns [cited by CMS].” Dr. Ansari adds that in addition to cataract surgery, he performs goniotomies, MIGS, biopsies, oculoplastic, and pterygium surgeries in his OBS suite.
Dr. Ansari thinks opposition to OBS may be based in part on a lack of awareness. “Some people think that ‘office-based’ means that you’re operating in an exam lane,” he explains. “That’s not how it is. Office-based surgical suites are practically a mini-ASC.” Dr. Ansari says his OBS suite has separate preoperative waiting and postoperative recovery areas, as well as separate sterilization, instrument-cleaning, and storage supply rooms.
Highlighting their concern that procedures be performed safely, Drs. Ansari and Mac both say they voluntarily adhere to the credentialing requirements of one or more organizations, such as QUAD A, an international accreditation organization that sets quality and safety standards for outpatient surgical facilities. “We don’t have to do this, but we felt that it’s necessary to deliver a quality product that is safe and certified,” says Dr. Mac.
“I would easily say that office-based surgical suites conform to all the requirements of an ASC and probably even a little bit more just because it’s relatively new,” Dr. Ansari says. He thinks CMS may consider requiring accreditation by a nationally recognized organization such as QUAD A when reconsidering OBS facility payment in the future.
Both ophthalmologists say they also carefully screen their patients’ health status for OBS eligibility and limit their use of anesthesia to Class A and Class B medications for “light sedation,” as required by law. Both also note that their staff are provided with additional training to work alongside them during surgical procedures. In Dr. Ansari’s case, that training was provided by iOR Partners, a company based in Kansas City, Missouri, that assists ophthalmic facilities in developing and building OBS suites.
Other Advantages of OBS
The two doctors also point to several other advantages of OBS for patients and providers. For patients, these include greater familiarity with the staff, which they say can ease anxiety; less travel; and potentially lower costs compared to those associated with ASC-based surgery. They note that a growing number of private payers are covering OBS for cataracts and other eye conditions.
“We treat it as a procedure instead of a surgery,” says Dr. Mac. “We have a very nice system where you’re not on a gurney, you’re not wheeled into the facility. You’re given just oral sedation. There’s no need for an IV. We have massaging recliners, where patients get to relax before their procedure.”
For practices, OBS also offers an opportunity to compete more effectively, especially in “certificate of need” states like North Carolina and Kentucky. Such states (there are 35, plus the District of Columbia) essentially require proof that an ASC is needed in a certain area. In North Carolina, for example, state regulators determine that need; providers must then apply for a license to build and operate an ASC.
“But what typically happens is, the hospital lobby is so strong that they basically prevent independent providers from opening [ASCs] because they go in and scoop up the licenses,” says Dr. Mac. As a result, North Carolina has very few physician-owned surgery centers. “They’re all corporate or hospital-owned ASCs.”
Ultimately, Drs. Ansari and Mac argue, performing cataract surgeries and certain other procedures in an office surgical suite is analogous to performing implantable collamer lens (ICL) and LASIK procedures, which are routinely performed in office settings.
“You will do elderly LASIK patients that have the same morbidity as the patients that you’re doing in an ASC, yet many providers do those cases in their office-based suite,” Dr. Mac says. “ICL is an invasive procedure where … you’re [implanting] a lens inside of the eye. You’re not doing cataract surgery, but you’re doing the same exact thing [in the office]. Why wouldn’t you do cataract surgery?”
He also draws comparisons to oral surgery and colonoscopy, both of which can be performed in doctor’s offices.
“Colonoscopy is probably a more invasive procedure than cataract surgery,” says Dr. Mac. “They’re using deeper sedation. They’re not just doing midazolam. They’re typically using propofol in a higher-risk procedure.”
Opponents: OBS Safety Remains a Question
Opponents such as OOSS, AAO, ASCRS, and most other ophthalmic professional groups, meanwhile, maintain that CMS made the right decision. They argue that patient safety trumps all other advantages of OBS and, in their view, the jury’s still out.
“For me, it’s not a ‘happy or not happy’ thing,” says Dr. Whitman, the president and chief surgeon at Key-Whitman Eye Center in Dallas. “It’s more of a ‘what’s safe for the patients’ issue.” In his view, the credentialing and safety protocols that OBS practitioners adhere to fall short of those required of ASCs. Pointing out that OBS suite credentialing and protocols are mostly voluntary, Dr. Whitman says ASCs are required to follow strict protocols and to undergo periodic recertification inspections by state and federal agencies, such as CMS and the Joint Commission.
In addition, Dr. Whitman argues, the patient screening measures described by proponents such as Dr. Ansari and Dr. Mac are subjective and don’t sufficiently reduce the risk of complications, even in otherwise healthy patients deemed appropriate for OBS.
“Where is the printed criteria [to show] that this patient is healthy enough for me to operate on without any IV anesthesia or any monitoring, and to give an oral medication?” he asks. “The issue is that you’re still doing something on the body. When you operate on the eye, you often [induce bradycardia]. Their heart rate gets low, and you’re dealing with people that may be stable on their medications but still have arrhythmias even though they’ve never had one before.”
Regarding the Kaiser Permanente study often cited by OBS proponents to support their safety claims, Dr. Whitman points out that the cataract procedures in the study were not performed in an actual office-based suite. Instead, they were performed in a separate area of the hospital and an anesthesiologist and another doctor stood by in case they were needed.
“I’m discounting the Kaiser study because it’s not [the office-based surgery] model,” he says. “These were not examples of actual OBS suites. [Proponents] keep citing that study, [but] it’s not an example of the center that you would have in your office.” Noting the opposition of numerous ophthalmology and surgery center groups to OBS, he says, “This isn’t a single doctor thing, this isn’t a single organization thing. All these organizations consider it a problem.”
Looking Toward 2025
Those on both sides of the issue agree CMS’s decision is not the end of the story. Facility reimbursement for OBS is expected to come up again in two years, when CMS’s Relative Value Update committee begins reviewing payment determinations for 2027.
By then, OBS supporters believe they will have amassed enough additional data for OBS to clear regulatory hurdles and gain acceptance of their cause.
“We used to only be able to do cataract surgery in a hospital, and then the technology sufficiently advanced [to the point] where we could do cataract surgery in an ambulatory surgery center,” observes Dr. Mac. “Medicare recognized the outcomes and the quality were equivalent, so they allowed it.”
The eyecare and surgery center groups, meanwhile, resolve to keep a close eye on the research and ensure that patient safety remains a top priority whenever CMS reconsiders office-based eye surgery.
“The final rule provides a modest respite from CMS activity in this regard,” OOSS said in a statement issued after the CMS decision. “We can expect promoters of office ophthalmic surgery to continue to press for facility reimbursement for cataract, retina, and glaucoma surgical services. OOSS will continue to be vigilant in protecting our patients.” OASC
REFERENCES
- 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):723-728. doi:10.1016/j.ophtha.2015.12.020
