March 2021

CATARACT

The pros and cons of office-based cataract surgery


by Liz Hillman Editorial Co-Director

 

In an OR in Dr. Cotter’s ASC, a nurse anesthetist delivers pain/anxiety medication through an IV, an RN circulator manages the room environment, and a dedicated ophthalmic technician and surgeon concentrate solely on executing the cataract operation.
Source: Frank Cotter, MD

Dr. Singh uses the 3D microscope that will be in his office-based OR.
Source: Inder Paul Singh, MD

 

For the private practice ophthalmologist, nothing can be more frustrating than trying to obtain ownership in an ASC, operating in a hospital, building an ASC, or just trying to find a place to operate that will give you block time. With that said, there are different models coming into play over the coming years. This is a hot topic among young eye surgeons and has drawn CMS attention in the past. Are these in-office surgery suites going to be held to the same safety standards? Do they offer the same guidelines that traditional hospitals and ambulatory surgery centers do? This is all yet to be determined but will become critical in the future of eyecare. I think this single factor could make or break many partnerships going forward. It will also be a difficult task in recruitment of young eye surgeons. This article highlights the pros and cons of cataract surgery performed in the office setting.

­—Michael Patterson, DO
YES Connect Co-Editor

In 2015, CMS included a request for information on office-based “nonfacility” cataract surgery in its proposed revisions to 2016 Medicare Physician Fee Schedule payment policies.1 In response, ASCRS surveyed its members to learn their thoughts regarding nonfacility cataract surgery. The survey revealed a nearly equal split: 52% were willing to perform cataract surgery in an office, while 48% were not.2 With input from the survey, ASCRS submitted comments to CMS, noting patient safety as an important factor, cautioning CMS to “think through all possible complications and issues” that could be associated with office-based cataract surgery.” ASCRS also acknowledged the possible benefits that office-based cataract surgery could provide physicians and patients, namely flexibility in scheduling, convenience, and importantly, access for physicians who live in states with certificate of need requirements and who don’t have access to ASCs.
As a procedure with a “high level of intensity,” ASCRS wrote on various factors that CMS should consider, including patient safety, management of unexpected complications, anesthesia, and certification requirements. ASCRS at the time reemphasized to CMS that given the often elderly patient population, frequently with multiple comorbidities, “cataract surgery should not be trivialized.”
In the final rule for CY 2016, CMS did not assign nonfacility PE RVUs for cataract surgery, but wrote in part:3
Advancements in technology have significantly reduced operating time and improved both the safety of the procedure and patient outcomes. As discussed in the proposed rule, we believe that it now may be possible for cataract surgery to be furnished in an in-office surgical suite, especially for routine cases. Cataract surgery patients require a sterile surgical suite with certain equipment and supplies that we believe could be a part of a nonfacility- based setting that is properly constructed and maintained for appropriate infection prevention and control.
CMS stated that it would “use this information as we consider whether to proceed with development of nonfacility PE RVUs for cataract surgery.” No further changes have occurred in the years since.
EyeWorld spoke with two ophthalmologists on the topic of office-based cataract surgery. One, Frank Cotter, MD, is opposed to office- based cataract surgery unless it meets basic patient safety measures appropriate for cataract surgery and required of ASCs. The other, Inder Paul Singh, MD, was in the process of finishing up his own office-based OR suite in January.  
Concerns for patient safety, reimbursement potential, and more Dr. Cotter acknowledged that there is a potential attraction to office-based surgery (OBS) for some cataract surgeons. OBS offers greater flexibility for the surgeon in many localities and ownership opportunities in ASCs are often complicated by onerous certificate of need laws and expensive buy-ins, he explained.
However, Dr. Cotter thinks the perspective of the patient trumps any surgeon convenience. “Would patients not prefer a nurse anesthetist to manage their intraoperative pain and anxiety? Would patients not prefer professional registered nurses preoperatively and postoperatively to assess and monitor them, prepare them for surgery, and explain their postoperative instructions? Would patients not expect that a backup generator was available in case of a power outage? Would patients not expect airflow handling to prevent airborne pathogens? What about a firewall around the surgical suite?”
Dr. Cotter thinks that any reasonable patient would expect those safety precautions are required for any facility hosting cataract surgery.
“While these patient safety standards are mandated federally in ASCs, there is tremendous variability in OBS requirements from state to state, with no requirement for these basic safety standards in some states. For example, the state of Wisconsin is one of several states that has no law regulating OBS, and there are no licensure or accreditation requirements. Furthermore, unlike OBS, ASCs are subjected to frequent unannounced inspections, which greatly enhances compliance.”
Dr. Cotter noted that 88% of patients who have cataract surgery in an ASC have at least two comorbidities. His practice sees cancellations every day due to previously undiagnosed, serious medical conditions, some of which require a call to 911.
“Proponents of OBS claim that they intend to only operate on patients with ‘no or low-risk’ comorbidities. If that is the case, how can any OBS remain profitable with only 12% of their cataract patients healthy enough for surgery in their office?” Dr. Cotter asked.
Dr. Cotter advocates for a uniform set of patient safety standards for office-based cataract surgery “so that patients can be assured that every facility hosting cataract surgery is safe.” To accomplish this goal, Dr. Cotter and several other eye surgeons are working with the Virginia Board of Medicine and the Virginia Legislature to enact legislation that would require basic safety standards for cataract surgery.
“Hopefully, once we establish appropriate patient safety standards for the cataract patient in Virginia, then other states will follow until we reach the ultimate goal of uniform patient safety for cataract surgery that currently exists in the ASC.”
Dr. Cotter emphasized that ASC facility fees for cataract surgery have risen every year. “ASCRS, the Outpatient Ophthalmic Surgery Society, and the American Academy of Ophthalmology have worked hard to get ASC facility fees linked to hospital reimbursement. Also, these organizations were successful in getting our inflator raised from CPI to the hospital market basket,” Dr. Cotter said. 
Dr. Cotter also noted that OBS is not eligible for Medicare reimbursement, something he said is unlikely to change in the next few years.
“Importantly, if there ever is any Medicare facility reimbursement for OBS, it will only be a site of service differential that amounts to a fraction of the ASC facility fee. That small fee, like our physician fees, will likely drop every year since it isn’t tethered to the hospital rate and the hospital market basket inflator.”  

A proponent of office-based cataract surgery

Dr. Singh performs surgery in a hospital, an ASC, and most recently, he is setting up an office-based OR. He thinks there is a time, place, and situation for each location.
“You still need hospitals. There are certain patients who need the infrastructure of a hospital setting, such as those with high-risk comorbidities,” Dr. Singh said, adding that ASCs are valuable as well because they may have more anesthesia options and operational efficiencies.
Where Dr. Singh thinks office-based surgery is appropriate is in routine cataract surgery for patients with no or low-risk comorbidities.
Dr. Singh decided to include an OR suite in the office he was building because of the flexibility it offered. When he wants to try a new piece of equipment or engage in a research project, he has more control over the process, he said. He is planning on incorporating the latest cataract surgery technology in the suite, including a 3D heads-up display microscope. He also likes the freedom of surgical scheduling, which he said can be a “nightmare” in a hospital or when operating in an ASC with multiple surgeons.
Dr. Singh thinks office-based surgery gives him more control over the patient experience as well. He thinks patients like being able to go to the office they’re familiar with for surgery vs. a previously unvisited ASC. It can help stress levels before and during the procedure as well, which in turn can decrease the need for IV anesthesia.
Dr. Singh’s office-based surgery suite will be accredited as a Class B surgery center, which allows for monitored sedation, whether oral or IV. All states require Class B office-based surgery centers to be accredited and/or state surveyed, he said. There are three national organizations that can accredit office-based surgery centers: the Joint Commission, the Accreditation Association for Ambulatory Health Care, and the American Association for Accreditation of Ambulatory Surgery Facilities. Third-party accreditation requires quarterly peer-review, Dr. Singh explained. These accreditation standards also require backup power, an anesthesia provider (CRNA, anesthesiologist), a dedicated RN for postop patients, and all of the other pertinent standards to ensure safe and effective care for office-based surgery.
Dr. Singh said ASCs have to follow a standard set of federal regulations that cover all specialties; state laws also come into play. Office-based surgery suites, he continued, can be tailored to the safety standards that are most applicable to the procedures performed and equipment used for ophthalmology.
He is going to be using a clean air zone unit (Operio Mobile, Toul Meditech) with an integrated detachable instrument tray, to be used in the operating zone. This unit produces a directed, non-turbulent, ultra-clean air flow to the surgical site and to the sterile instruments used during surgery. Dr. Singh said this unit has been shown to lower particle counts surrounding the sterile field compared to that in hospital and ASC ORs.
As for firewall protection, Dr. Singh said this is required for cases that might take longer, as in many non-ophthalmology cases that would need time for the patient to wake up to stabilize. Due to the efficient nature of cataract surgery, Dr. Singh doesn’t think the same firewall standards are needed for a standard cataract case. He added that office-based surgery is accredited to the license of the surgeon, therefore no non-ophthalmology cases can be done in that space. 
Dr. Singh also mentioned that he likes the idea of the staff being focused on ophthalmology rather than being pulled away for other subspecialties as they might be if they worked in a multispecialty ASC. Dr. Singh said he likes that staff members in his office will participate in patient care from the first visit through the last day of postop care, which he thinks helps provide continuity and a sense of ownership/responsibility for the staff.
Safety is no doubt a major concern and a common reason for the pushback against office- based cataract surgery, Dr. Singh said.
“Surgeons who are unfamiliar with office- based surgery centers assume surgery is being done in a ‘clean room’ or traditional procedure room,” but Dr. Singh described the space used for office-based ophthalmic surgery as being built and run with processes and protocols that are similar to ASCs. He also mentioned a retrospective review from a Kaiser Permanente facility in Denver, Colorado of more than 21,000 eyes that showed good visual outcomes and safety, with no cases of endophthalmitis, within what is considered a non-ASC setting.4
“I am happy to have the ability to use a hospital, I’m happy I have the ability to use an ASC, and I’m happy I have the option to use an in-office cataract suite. I think we need them all. When done right, an in-office cataract suite can be a safe alternative to a hospital or ASC,” Dr. Singh said.

About the physicians

Frank Cotter, MD

Roanoke Valley Center For Sight
Vistar Eye Center
Roanoke, Virginia

Inder Paul Singh, MD
Eye Centers of Racine
and Kenosha
Racine, Wisconsin

References

1. CMS. Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016. Published July 15, 2015.
2. Daly R. Little appetite for office-based cataract surgery. EyeWorld. 2017;22:80–81.
3. CMS. Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016. Published Nov. 16, 2015.
4. Ianchulev T, et al. Office-based cataract surgery: Population health outcomes study of more than 21,000 cases in the United States. Ophthalmology. 2016;123:723–728.

Relevant disclosures

Cotter
: None
Singh: None

Contact

Cotter
: fcotter@vistareye.com
Singh: ipsingh@amazingeye.com

ASCRS comments to CMS request for information on nonfacility cataract surgery

In 2015, ASCRS offered several comments, with input from a survey of its members, to CMS regarding nonfacility cataract surgery. Here are a few of the key points made by ASCRS:
• Even routine cataract surgery can face unexpected complications. As such, “all locations where cataract surgeries are performed would need to be equipped to deal with both complicated and non-complicated cataract surgeries, including in-office surgical suites.”
• CMS had stated that topical/intracameral anesthesia was most common for cataract surgery, but ASCRS in its comments corrected that most of its members used “intravenous anesthesia or sedation for cataract surgery as an addition to local or topical anesthesia.” Some patients, ASCRS continued, need even further anesthesia, so “the use of CRNAs and anesthesiologists during cataract surgery is essential.” ASCRS also noted the possibility of cardiac events with use of epinephrine or phenylephrine. “These issues illustrate that intraocular surgery with anesthesia remains an intensive surgery that has significant risks.”
• ASCRS emphasized the need for “safety standards, infection control, and quality assurance/benchmarking requirements. There needs to be an assurance of the standard of care in sterility, equipment, staffing and anesthesia.” ASCRS stated that these areas need to be similar to that of an ASC and that “regulation of in-office surgical suites at both federal and state levels,” as well as development of certification requirements, would need to be addressed.
• ASCRS agreed with CMS that office-based surgery could offer physicians and patients more flexibility, especially in states with certificate of need laws. “It may also be more convenient for patients, especially the older Medicare patient population our members tend to treat, to visit one office for the surgery, pre- and postoperative care. Office-based surgical suite cataract surgery might offer a more flexible option for both patients and providers.”
• ASCRS discussed the need for valuing direct practice inputs for office-based cataract surgery for an accurate nonfacility payment rate.

The pros and cons of office-based cataract surgery The pros and cons of office-based cataract surgery
Ophthalmology News - EyeWorld Magazine
283 110
220 168
,
2021-03-02T10:53:16Z
True, 3