CMS assesses office-based cataract surgery

Due to improvements in technology, methods and safety, cataract surgery moved from primarily hospital-based settings to ambulatory surgery centers in the last two decades. Today, some surgeons are considering performing cataract surgery in office-based settings.

Proponents say that cataract surgery is more cost-effective for surgeons and more comfortable and convenient for patients in an office than in an ASC. Others have concerns about patient safety and the economic viability of office-based cataract surgery.

The conversation about in-office cataract surgery is not new, considering the unavailability of ASCs in some certificate of need states, according to Kevin J. Corcoran, COE, CPC, CPMA, FNAO, OSN Practice Management Board Member.

Image: Chu YR

“This is an old idea, and it came about in part because ambulatory surgery centers in some states are not readily approved, at least for Medicare,” Corcoran said. “An unlicensed ASC is categorized as an ‘office’ for Medicare’s purpose.”

CMS pays surgeon fees for cataract surgery in hospitals, ASCs and offices but does not pay facility fees for in-office cataract surgery.

In 2015, CMS requested information from stakeholders about non-facility cataract surgery. The agency is reviewing responses from various parties and is considering the development of non-facility practice expense relative value units for in-office cataract surgery. The request was included in the 2016 Medicare Physician Fee Schedule.

“We believe that it is now possible for cataract surgery to be furnished in an in-office surgical suite, especially for routine cases. For example, routine cases in patients with no comorbidities could be performed in the non-facility surgical suite, while more complicated cases (for example, pseudoexfoliation) could be scheduled in the ASC or [hospital outpatient department],” the CMS Request for Information said.

Some private insurers and regional health care systems have embraced in-office cataract surgery. For example, cataract surgery is being performed in minor procedure rooms at Kaiser Permanente medical centers in California, Colorado and Washington. The surgery is performed with only a registered nurse assisting. Additionally, surgeons are performing bilateral same-day cataract surgery in most cases in Kaiser Permanente centers in those states, according to Ianchulev and colleagues, whose study on cataract procedures performed in Kaiser Permanente Colorado medical offices was published in Ophthalmology.

Study on in-office cataract surgery

In the Ophthalmology study, Ianchulev and colleagues said that office-based efficacy outcomes were “consistently excellent,” with safety profiles comparable to those of procedures performed in ASCs and hospital outpatient departments.

The study was the largest of its kind in the U.S. to evaluate the safety and effectiveness of office-based cataract surgery performed in minor procedure rooms of a large integrated health care center, the authors wrote.

The study looked at cataract surgery performed in minor procedure rooms on 21,501 eyes of 13,507 patients with a mean age of 72.6 years.

Systemic comorbidities included hypertension (53.5%), diabetes (22.3%) and chronic obstructive pulmonary disease (9.4%).

Postoperative mean logMAR best corrected visual acuity was 0.14.

Intraoperative adverse events included 119 cases of capsular tear and 73 cases of vitreous loss. Postoperative adverse events included 330 cases of iritis, 110 cases of corneal edema and 30 cases of retinal tear or detachment. No cases of endophthalmitis were reported. Second surgeries were performed on 0.7% of treated eyes within 6 months. No life- or vision-threatening intraoperative or perioperative adverse events were reported.

More than 80% of cataract surgeries are performed in free-standing ASCs, with most remaining cases being performed in hospital outpatient departments, the authors wrote.

According to the study, at the Kaiser Permanente Colorado medical offices in the Denver area, ophthalmologists have been performing cataract surgery in minor procedure rooms since 2006, with two advanced cardiac life-support certified registered nurses and a surgical technician in attendance. No anesthesiologist is normally present, and no intravenous lines or injections are normally used. Topical intracameral anesthesia is normally used, with oral triazolam sedation.

In early 2011, 84% of Kaiser Permanente Colorado cataract surgeries were performed in an office setting. The percentage increased to 93% of cataract procedures in 2014 and more than 95% in the third quarter of 2015, the authors said.

Concerns about safety

In-office cataract surgery deserves further examination, but patient safety is the most important factor, according to Eric D. Donnenfeld, MD, OSN Cornea/External Disease Board Member.

“The No. 1 priority for all surgeons should be what’s best for patients. Right behind that is to be cost-effective. So, I see in-office cataract surgery as an opportunity to look at these two issues from a distance and really ask ourselves, ‘Is this better for patients and is it cost-effective?” Donnenfeld said.

According to Donnenfeld, not having the latest equipment in offices would compromise safety and outcomes.

“The technology that we have is expensive but important for patient care,” he said. “If we’re not going to have that technology in the office, then I think patients suffer. If we are going to have the technology in the offices, then it’s very difficult to understand how you’re going to have a cost savings.”

Donnenfeld also expressed doubt that offices can handle the same patient volume as ASCs.

“This high number of cataract surgeries creates economies of scale that can’t be achieved in an office unless you’re doing 10,000 or more cataracts a year in an office. The economies of scale that we achieve in a well-run ASC make the incremental cost of each case fairly negligible,” Donnenfeld said.

In-office cataract surgery compares favorably with surgery in an ASC in terms of safety under the appropriate conditions, according to Barrett Eubanks, MD, who performs in-office cataract surgery at his practice, Hunter Vision, in Orlando, Fla.

“The safety of doing in-office cataract surgery can match that being done in a surgical center if the appropriate steps are taken. Here, we have sterilization equipment and everything is sterilized the exact same way that it would be done in the surgical center. We’re scrubbing in exactly the same way we would in a surgical center,” Eubanks said. “Given that you have a lot more control over preoperative drops and things like that within an office setting, since you have more control over the staffing that can use those drops, you can be sure that [patients are] getting the appropriate amount of drops, getting the appropriate amount of Betadine within the eye itself in order to sterilize the eye. So, I don’t see any drop in safety moving from a surgical center in order to do in-office cataract surgery if the appropriate steps are taken to bring it up to the same standards as what a surgical center would be.”

Patient safety is paramount for cataract surgeons, regardless of the site of service, according to Tony Burns, MBA, CASA, CSFA, president of Invoegen Surgical Services LLC, a consulting firm that helps practices set up in-office surgical suites.

“In 27 years of working in this industry, I have yet to meet a physician who would intentionally put a patient in harm’s way for profit,” Burns said. “One thing we pound into the physician’s and staffs’ psyche is that this is all about patient selection. If the patient has comorbidities or significant medical issues, take them to a facility that is equipped and trained to handle those patients. Just because you have an in-office suite does not mean you have to do every patient in it. A lot of my ASCs are multispecialty. Physicians across the spectrum do this on a daily basis. They do every patient that can be done in the ASC and they take the rest to the hospital.”

Patient comfort and convenience

Besides being safe, in-office cataract surgery is comfortable for patients in routine cases, Eubanks said.

“One of the biggest concerns in moving from a surgical center in order to do in-office cataract surgery is not having an anesthesiologist on site. That essentially has not been an issue,” he said. Patients are medicated to increase their comfort level, and the surgery itself has become routine and predictable, without the need for an anesthesiologist, he said.

However, challenging cases, in which medical or logistical complexity is anticipated, are still performed in ASCs where anesthesiologists are on hand.

“For those sort of things, we would still use the surgery center,” Eubanks said.

In addition, having cataract surgery in an office setting is more convenient for patients than having it in an ASC, Eubanks said.

“[Patients are] quickly in and out of our center faster than they would be in a surgery center, and they don’t have any other locations they need to drive to,” he said.

Responses to CMS query

CMS included the request for information in the Medicare Physician Fee Schedule after some internal discussion, according to CMS. The request was simply an effort to initiate a dialogue between CMS and stakeholders about non-facility fees for in-office cataract surgery.

Most comments were not in favor of non-facility fees for in-office cataract surgery, according to CMS. However, there were some favorable comments, among them the idea that in-office cataract surgery is appropriate for patients without medical comorbidities who can be managed by an anesthesiologist.

In a response letter to the CMS request, the American Society of Cataract and Refractive Surgery stressed the importance of patient safety: “First and foremost, patient safety is paramount, along with the real possibility of complications. The use of anesthesia, including intravenous sedation, and the certification requirements for in-office surgical suites are also important factors.”

Corcoran said, “I believe that owners of ambulatory surgery centers have spent a lot of time and money to become certified and see this as a threat.”

“In-office cataract surgery is not likely to save a lot of money but still deserves consideration,” he said. “It might possibly save a few hundred dollars per case but not a thousand dollars.”

“I don’t believe the regulatory aspects have been worked out yet concerning certification and/or licensure of in-office operating rooms, so there are a bunch of unknowns,” he said.

ASCRS addressed those thoughts in its letter: “There will be significant costs associated with providing cataract surgery in an in-office surgical suite that would need to be accounted for in determining an accurate non-facility payment rate.” Costs for equipment, technology, anesthesia and nursing staff, certification requirements, labor and other supplies, as well as indirect costs of construction and maintenance of an office-based surgical suite and increased overhead, would also need to be addressed, according to the letter.

Both the Outpatient Ophthalmic Surgery Society (OOSS) and the American Academy of Ophthalmology also responded to the inquiry from CMS.

In an open letter to CMS, OOSS President Y. Ralph Chu, MD, said that “cataract surgery should be performed only in a facility, such as an ASC or a hospital, that meets rigorous and well-established patient health and safety standards.”

In an interview with Ocular Surgery News, Chu termed the possibility of CMS assigning practice expense relative value units for office-based cataract surgery under the Medicare Fee Schedule “ill-advised and premature.”

“Our focus at OOSS is patient safety,” Chu said.

Chu said that ASCs already have safety standards similar to those that hospitals must meet.

In its response, the AAO stated that the prospect of facility fees for cataract surgery should be explored.

“Certainly, some of the positive aspects as cited by CMS should be explored as well as the limitations that have kept this and other ophthalmology procedures primarily facility based,” the AAO response said. “All of the issues discussed suggest that at a minimum, an accurate enumeration of the practice expenses in the office setting be developed and funded to make office-based cataract surgery feasible.”

The AAO recognized that “it is because of the significant safety and safeguards afforded by Medicare accredited and certified facilities” that significant improvements have been achieved.

“These standards need to be maintained in all surgical settings. Additionally, CMS emphasizes that cataract surgery patients require a sterile surgical suite with certain equipment and supplies that we believe could be a part of a non-facility-based setting that is properly constructed and maintained for appropriate infection prevention and control. However, CMS has no requirements that regulate the construction, maintenance and sterility of office-based surgery. Unlike [hospital outpatient department] or ASC settings, there are no conditions of participation/coverage for the physician’s office,” the AAO statement said.

Donnenfeld said there are concerns about offices being able to maintain high safety standards and contain costs.

“I think that when they [CMS] do their due diligence, they’re going to see that while it’s an interesting idea, it doesn’t meet the two criteria that I find important. One, I know it won’t be better for patients. Two, there isn’t going to be a cost savings to the government unless we significantly dilute our standards of care,” Donnenfeld said.

Looking ahead, any proposed non-facility fee for in-office cataract surgery would go through a rule-making process before being included in the Medicare Physician Fee Schedule, according to CMS.

Reimbursement concerns

“Surgeons who are considering in-office procedures must find a way to pay for the necessary equipment and supplies. Under the current Medicare payment methodology, only the intraocular lens is separately reimbursed — all other supplies used in office are not. Surgeons would need to find new revenue streams to compensate for a lack of reimbursement,” Corcoran said.

“To make in-office cataract surgery more economically viable, surgeons would likely favor those cases with non-covered elements, such as premium IOLs and laser correction of astigmatism,” Corcoran said.

“At present, the covered procedure doesn’t have enough reimbursement to be viable because a professional fee alone is not large enough to pay for the needed medications, supplies and equipment,” he said. “Alternatively, to incentivize this approach, CMS might adjust the site of service differential for cataract surgery to make in-office procedures reimbursed at a significantly higher rate than those cases performed in an ASC or hospital outpatient department.”

“The site of service differential presently is zero for cataract surgery. If you do it in your office or in a hospital or an ASC, the surgeon gets paid the same,” he said. “For this to work, CMS would have to revise those two numbers such that when it is done in your office, it pays more than when it’s done in an ASC or hospital. How much more is a matter of debate. It would need to be several hundred dollars.”

Some surgeons who perform in-office cataract surgery are reimbursed by commercial insurance or third-party administrators, Burns said.

“The [relative value unit] should be the same for the pro fees. Where the surgery is done shouldn’t add any additional expense or effort on the surgeon’s part,” Burns said. ”The facility side is more complicated. There is no in-office reimbursement for Medicare at this time. That is what the comment period for this is all about.”

ASCs bill for cataract surgery under the same CPT codes as the physician, 66984 and 66982, Burns said.

According to the Ambulatory Surgery Center Association, the Medicare facility fee averaged $964 for ASCs and $1,670 for hospital outpatient departments in 2013.

In addition, nearly all surgeons who operate in office do bilateral cataract surgery, Burns said.

Cataract surgeons may have a significant financial investment in their surgery center, Chu said.

“Surgery centers are already reimbursed at a significantly lower rate than hospital outpatient surgery centers for the exact same service and same set of regulations. OOSS’s goal is to protect the progress we have made in ASC reimbursement and preserve patient safety and quality outcomes,” he said.

Office vs. ASC vs. hospital

In states that do not permit ASCs, surgeons mostly operate in hospitals, Corcoran said.

“But a surgeon in a hospital finds that cases are slower than they would be in an ASC. They’re more expensive from the patient’s point of view than they are in an ASC. They are administratively more complex. At present, 70% of all cataract surgery performed on Part B Medicare beneficiaries is performed in ASCs because the environment is patient friendly and surgeon friendly,” he said.

Most surgeons would prefer to operate in ASCs if possible, Chu said.

“I think that many doctors would prefer to have a surgery center environment because of their efficiency including all the other things in place, like anesthesia, a nursing staff, all the other support, pre- and postoperative recovery areas,” Chu said. “But what could be said is that in states where it’s difficult for ophthalmologists to get access to a [certificate of need] or surgery center, this would empower some of those ophthalmologists. ... I think the benefit potentially for in-office surgery would be for those surgeons who can’t have access to a surgery center and they want a little more independence from a hospital system.”

Burns said that ASCs are typically classified by the type of anesthesia used, not the types of procedures done in the facility.

“There are states that also classify the procedure types as well, but that’s not the majority of states. The majority of the states and the third-party accreditation agencies class you by the anesthetic type,” Burns said.

Surgery centers that use intravenous anesthetics are categorized as class B.

“In most states, class B or higher requires accreditation. For class A or below, when you’re giving local, topical or oral anesthetics, most states don’t even regulate those classes. If they do, it’s a very simple accreditation or registration process,” Burns said.

“There are multiple economies of scale, and in class A centers, which are the only in-office suites I have developed, you don’t have anesthesia costs. When we are with a client who is thinking of doing an in-office suite, we always do a pro forma first. If we can’t justify the expense, we don’t move forward. I can tell you that [we have] never run into a facility that wouldn’t be profitable with moderate volume,” Burns said. – by Matt Hasson

• References:
• An open letter from the president of OOSS. Outpatient Ophthalmic Surgery Society. http://ooss.org/wp-content/uploads/OOSS_SEE_-MFS_Rule_Comments_Office-Surgery_.pdf.
• ASCRS Letter to Centers for Medicare & Medicaid Services. http://ascrs.org/sites/default/files/Final_MPFS_2016_ProposedRule_Comment.pdf. Sept. 8, 2015.
• CMS defers action on payment for office cataract surgery. Outpatient Ophthalmic Surgery Society. http://ooss.org/2015/11/03/cms-defers-action-on-payment-for-office-cataract-surgery/.
• CMS soliciting comments on office-based cataract surgery. Outpatient Ophthalmic Surgery Society. http://ooss.org/2015/07/09/cms-soliciting-comments-on-office-based-cataract-surgery/.
• Ianchulev T, et al. Ophthalmology. 2016;doi:10.1016/j.ophtha.2015.12.020.

• For more information:
• Tony Burns, MBA, CASA, CSFA, can be reached at Invoegen Surgical Services LLC, 1349 Denver St., Boulder City, NV 89005; email: invoegensurgical@live.com.
• Y. Ralph Chu, MD, can be reached at Chu Vision Institute, 9117 Lyndale Ave., South Bloomington, MN 55420; email: yrchu@chuvision.com.
• Kevin J. Corcoran, COE, CPC, CPMA, FNAO, can be reached at Corcoran Consulting Group, 560 E. Hospitality Lane, Suite 360, San Bernardino, CA 92408; email: kcorcoran@corcoranccg.com.
• Eric D. Donnenfeld, MD, can be reached at OCLI, 2000 North Village Ave., Rockville Centre, NY 11570; email: ericdonnenfeld@gmail.com.
• Barrett Eubanks, MD, can be reached at Hunter Vision, 8701 Maitland Summit Blvd., Orlando, FL 32810; email: barrett.eubanks@gmail.com.

Disclosures: Burns is president of Invoegen Surgical Services LLC. Chu reports he owns an ASC. Corcoran reports he is president of Corcoran Consulting Group. Donnenfeld reports he owns an ASC. Eubanks reports no relevant financial disclosures.

Should cataract surgery be performed in an office setting?

In-office surgery ready to go mainstream

We recently reported experience of more than 21,000 office-based cataract procedures, which demonstrated postoperative visual acuity and safety well within today’s expectations. Topical anesthesia, the self-sealing clear corneal incision, phacoemulsification power modulations and fluidics, foldable IOL injectors and intracameral antibiotics have transformed cataract surgery into a procedure well-suited for the in-office surgical suite. The skills of the assistant and the surgeon, the proper adherence to aseptic technique, and the required machinery, instrumentation and sterilization facilities translate easily from the ASC to the office clean room. Currently, Medicare carriers will compensate the surgeon and pay the nominal cost of an IOL, but do not provide a facility fee, making the performance of routine cases financially untenable for most providers. However, out-of-pocket payments for services associated with the correction of astigmatism and presbyopia make office-based refractive cataract surgery a very attractive option. In the near future, routine bilateral same-day office-based cataract surgery will likely become standard of care.

• Reference:
• Ianchulev T, et al. Ophthalmology. 2016;doi:10.1016/j.ophtha.2015.12.020.

Mark Packer, MD, is a clinical associate professor, Oregon Health & Science University, and president, Mark Packer MD Consulting, Inc., Boulder, Colo. Disclosure: Packer reports no relevant financial disclosures.

ASC is ideal setting for cataract surgery

Outpatient surgery for cataract and other ophthalmologic procedures has become the perfect environment to provide the highest level of quality care to patients. High levels of patient satisfaction and extremely low rates of complications have become the norm. In-office cataract surgery poses a significant risk to losing the high level of care we have achieved with this system.

Outpatient surgery centers have a high level of quality controls encompassing all areas, including infection prevention, that does not exist for in-office surgery. Creating those systems will be time consuming and costly. Additional bureaucracy and intrusion into the office environment by state agencies will be unavoidable. It is likely that there will be wide variations in rules and regulations between the states and the federal government creating significant confusion.

Cataract surgery is already a very undervalued procedure with regard to reimbursement. There is no doubt that in-office surgery will result in a lowering of reimbursement for all cataract surgery, including outpatient surgeries. This could result in significant financial issues for surgery center owners and prevent new centers from opening.

Ultimately we must do what is best for our patients. The outpatient surgery center is the best place for a person to achieve an outstanding result for cataract surgery.

Mark Kontos, MD, is a senior partner at Empire Eye Solutions, Spokane, Wash. Disclosure: Kontos reports he is a consultant for Abbott Medical Optics and Allergan.