Cataract surgery is the most commonly performed surgery worldwide, and the demand for cataract surgery in the United States is expected to increase precipitously as the population ages over the next decade. The increased number of patients in need, combined with declining numbers of surgeons, puts even more pressure on the medical system and amplifies the need for safe and efficient delivery of care.

Could the answer be office-based surgery (OBS)? Are mobile surgical units coming to a town near you? CMS is investigating the possibilities, but experts warn that a lot of significant details would need to be worked out first.

FROM INPATIENT TO OUTPATIENT

Historically, cataract surgery was performed exclusively in the hospital setting. Surgeries took longer to accomplish, and the postoperative risks were much greater. Because the corneal incisions were large, patients were kept as inpatients for up to a week to avoid excessive movement and strenuous activity that could increase postoperative complications.

After the 1985 ruling allowing Medicare-covered procedures to be performed in certain outpatient settings, cataract surgery moved to hospital outpatient departments (HOPD) or ASCs. The percentage of cataract surgeries performed in an outpatient setting has steadily increased ever since. A recent study reported an increase in ASC-based surgery from 43.6% in 2001 to 73% by 2014.¹ Currently there are more than 5,400 ASCs, with over 1,000 specializing in ophthalmic surgeries.²

ASCs provide surgeons with more efficient delivery of care, greater flexibility and control of scheduling and greater access to rapidly changing improvements in technology, as well as savings to Medicare. Patient out-of-pocket expense is less, insurers pay less and Medicare is reported to have saved $829 billion in 2011 as a result of movement to the outpatient surgical setting.³

WOULD ANOTHER MOVE SAVE MONEY?

In 2016, CMS issued a Request for Information regarding OBS for “routine” cataract surgery in its Medicare Physician Fee Schedule Proposed Rule. Undoubtedly, this exploration by CMS is, at least in part, based on a desire to reduce Medicare-covered surgeries to the lowest cost setting. Although CMS pays for cataract surgery procedures in hospitals, ASCs and offices, it does not pay a facility fee in unlicensed ASCs or for in-office cataract surgery.

Feedback received during this process largely centered around safety concerns and the understanding that, historically, a movement to lower-cost settings (such as ASCs) resulted in decreased reimbursement without any real cost savings to the surgery center and with an increasing regulatory burden over the years. Because safety standards would need to be uniform across all settings, it is hard to imagine how OBS would sufficiently reduce costs to offset a reduced level of reimbursements.^4-6

THE LOW-DOWN ON OBS

OBS procedures are defined as those that are relatively low risk and do not require emergency room equipment and staff who can handle possible emergencies. Patients with multiple comorbidities and on multiple medications are those most at risk for unexpected events, although any case can transform from “routine” to complicated without warning. Currently, standards and regulatory oversight of OBS vary widely between states, with some states only requiring completion of a form vs. requirement of accreditation similar to current ASC accreditation in more stringent states.⁷

Also in 2016, a retrospective study of 21,501 cataract surgeries in the Denver metropolitan area Kaiser office reported good visual outcomes and acceptable safety measures in patients selected for OBS in a single, large, controlled health system. Mean postoperative BCVA was 20/28, and intraoperative and postoperative complications were low.⁸

However, a larger safety concern remains: What happens when things don’t go as predicted or patients become unstable? The Kaiser offices have a “Nurse Stat” team and crash cart for emergencies and are located less than 1 mile from an affiliated hospital. Additionally, the Kaiser health network is a well-controlled and highly regulated organization that can systematize its processes of patient selection for OBS.

OOSS FINDINGS

In August 2015, the Outpatient Ophthalmic Surgery Society (OOSS), in cooperation with the Ambulatory Surgery Center Association (ASCA) and the Society for Excellence in Eyecare (SEE), conducted a survey of 170 ophthalmic ASCs representing more than 400,000 cases. Their findings: Only 6% of cataract surgeries had no comorbidities (hypertension, cardiovascular disease, cerebrovascular disease, pulmonary disease, endocrine disease and cancer), 88% had two or more comorbidities and most patients were on multiple prescription medications at the time of surgery (69% were taking over five prescription medications related to comorbidities).²

Michael Romansky, Washington Counsel for OOSS, concludes in the group’s response to CMS that “virtually all cataract patients are at risk unless their surgery is performed in office facilities that meet the standards of care comparable to those of ASCs and hospitals.”

Mr. Romansky urged CMS to include equivalent regulatory standards in OBS to those of the ASC, specifically referring to detailed rules pertaining to Life Safety Code, infection control, environment, anesthesia, nursing and governance as well as supervision.²

Certificate of Need states increase pressure on surgeons to find settings for surgery other than a hospital. In these areas, OBS may be the only means by which the surgeon can have control of efficiencies, scheduling and equipment. Because Medicare does not currently pay a facility fee in these settings, revenue streams outside of Medicare, such as premium IOLs, become an essential part of the equation. Practices are subjected to increased pressure to contain costs, such as eliminating anesthesia oversight, IV access and injectables, while maintaining smaller supply inventories.

OBS IN REAL LIFE

Melissa Toyos, MD, in Nashville, Tenn., has performed cash-only office-based cataract surgery at one location for three years and on more than 500 patients. She says that more than 99% of the surgeries performed in that center are same-day immediate sequential bilateral cataract surgery. These are most often upgraded, premium IOL procedures and comprise 15% to 20% of the total cataract surgeries the practice performs, with the remainder being billed through insurance and performed in an ASC or hospital. Patients with risk factors, such as large size, marginal cardiovascular status or those who are not able to cooperate, are not eligible for OBS.

Over the past three years, Dr. Toyos says, the only patient transferred to an area hospital was for intractable migraine headache.

The Toyos setting for OBS is a space that was previously an accredited ASC. It features an anesthesiologist on staff who is present for procedures; patients receive intravenous sedation (Versed and Fentanyl), and the office follows ASC accreditation guidelines in an effort to maintain standards equal to those required for an accredited ASC.

Dr. Toyos feels that having an anesthesiologist present to monitor the cardiovascular status of the patient is key. Trying to both perform surgery and manage the patient, she says, “is like trying to play ‘Twister,’ only with surgery,” with too much going on for the surgeon to cover everything, especially in an emergency.

SO MAYBE IT’S NOT THE NEXT BIG THING

If there is a future shift to alternative surgical settings, changes need to happen, with an emphasis on data regarding safety and with proper regulations and oversight in place. Studies comparing safety in OBS vs. HOPD and ASC are essential. The results should be used to ensure safety and efficiency of patient care as well as to define costs, so reimbursement is sufficient to enable practices to follow standards without cutting corners.

ASCs currently provide high quality, safe, efficient cataract surgery while following detailed regulations, which would have to be closely replicated in an office setting. The result of that, however, would be parallel settings that differ in name only and therefore have similar costs, with no real savings if appropriately reimbursed.

OTHER POSSIBILITIES ON THE HORIZON

So what will the operating room of the future look like? Efficiency, affordability and safety will, of course, continue to be driving factors. SurgiCube, based in the Netherlands, was cleared by the FDA for distribution in the United States in September 2017. According to the company website, SurgiCube provides a cost-sensitive “localized, optimally filtered, ultra clean surgical environment to carry out microsurgical procedures and minor surgeries.”

Odulair, based in Cheyenne, Wyo., builds mobile operating theatres transported by truck, primarily for use in military settings and overseas in underserved countries. Could an OR that’s modular, mobile or both be a possibility for cataract surgeries here?

The future will undoubtedly hold many challenges. Population demographics, a declining number of providers, corporate consolidation of practices and ASCs, hospital acquisition of ASCs and changing insurance coverage models, including the prospect of a single-payer system, are all forces that will influence how we provide ophthalmic surgical care.

Despite these pressures, the number one goal of ophthalmic surgery is safety. The challenge is to maintain the highest level of safety while optimizing outcomes, the patient experience, efficiency — and cost control. Today, these goals continue to be met and improved upon in the ASC setting. OM

REFERENCES

1. Stagg BC, Talwar N, Mattox CG, Lee PP, Stein JD. Trends in use of ambulatory surgery centers for cataract surgery in the United States, 2001–2014. JAMA Ophthalmol. 2018;136:53-60.
2. An open letter from the president of OOSS. Outpatient Ophthalmic Surgery Society. https://ooss.org/wp-content/uploads/OOSS_SEE_-MFS_Rule_Comments_Office-Surgery_.pdf . Accessed Feb.11, 2019.
3. Medicare cost savings tied to ambulatory surgery centers. Ambulatory Surgery Center Association. https://tinyurl.com/yyw5tkxa . Accessed Feb. 10, 2019.
4. 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 . Accessed Feb. 11, 2019.
5. 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 . Accessed Feb. 11, 2019.
6. Medicare Program: Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016 Final Rule. https://www.federalregister.gov/documents/2015/11/16/2015-28005/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisions . Accessed Feb. 11, 2019.
7. Murphy C, Shtern Y. What you need to know about office-based surgery laws. Physicians Practice. Feb 1, 2018. http://www.physicianspractice.com/law-malpractice/what-you-need-know-about-office-based-surgery-laws . Accessed Feb. 11, 2019.
8. Ianchulev T, Litoff D, Ellinger D, et al. Office-based cataract surgery: Population health outcomes study of more than 21000 cases in the United States. Ophthalmology. 2016;123:723-728.
9. An open letter from the American Society of Cataract and Refractive Surgery to Centers for Medicare and Medicaid Services. http://ooss.org/wp-content/uploads/FINAL-2017-ASCRS-OOSS-SEE-ASC-Rule-Comments.pdf . Accessed Feb. 11, 2019.

About the Author

Cathleen McCabe, MD, is the medical director of The Eye Associates, based in Florida. A graduate of Bascom Palmer Eye Institute at the University of Miami’s School of Medicine, Dr. McCabe serves as the co-chair for the cataract section of the Practicing Ophthalmologist Curriculum for the American Academy of Ophthalmology.