Decisions Must Be Data-Driven

In an ever-changing healthcare environment, research and data are imperative. So why are policy decisions made without enough relevant data to drive those decisions? Case in point: In February 2018, National Public Radio in the United States reported (1) that “your eye surgeon may have to do double duty as your anesthetist under a new policy by health insurer Anthem.” A clinical guideline released by Anthem, per the NPR report, said “it’s not medically necessary to have an anesthesiologist or nurse anesthetist on hand to administer and monitor sedation in most cases.” So imagine, you (or your mom or dad), is in need of cataract surgery. Someone is going to cut into your eye, relatively routine, but what does that actually mean? Be prepared that the surgeon who should be concentrating all of their education, skill, and focus on the delicate intraocular surgery to give you your best long-term chance at great vision, may now be distracted by the intraoperative control of your blood pressure levels, pain management, monitoring of your heart rhythm, and overall comfort during the often (but not always) short procedure.

In 2018, Anthem Insurance denied payment for anesthesia coverage during cataract surgery procedures. Put yourself in the patient’s shoes: imagine going for cataract surgery and because your ophthalmologist isn’t comfortable doing the surgery without an anesthesiologist, you receive a bill for the anesthesia component and your insurance company will not cover it. What do you do? Do you find an ophthalmologist who is comfortable to perform the surgery in an office-based setting? What if you have comorbidities that put you at a higher risk of complications, or anxiety? Does your ophthalmologist have the support staff to work that out and account for it preoperatively? What if an issue occurs and no anesthesiologist is present – how is the ophthalmologist supposed to focus on the surgery itself as well as try to manage any systemic issues with anesthesia?

The fact that the decision to not pay anesthesiologists was made without supporting data, and without available literature to drive that decision, is not just an economic issue, but an ethical one too. It’s why organizations like the Academy of Ophthalmology (AAO) and the Association of Cataract and Refractive Surgery (ASCRS) are fighting this stance – and why we need more data on how a patient’s physical status impacts cataract surgery outcomes.

The American Society of Anesthesiologists (ASA) classification was developed in the 1960’s, and evaluates the overall physical status of patients prior to surgery. The grading system is a significant predictor of postoperative outcomes in vascular and general surgery cases; in neurosurgery, high ASA classification is a risk factor for major medical complications; and high ASA status is also a predictor of postoperative morbidity and mortality after cardiac and major non-cardiac operations. Of the six ASA classes, four are relevant to ophthalmology, however the relationship between ASA class and ophthalmic postoperative outcomes is not well understood. Moreover, though large studies, which are often referenced, have evaluated the burden and cost-effectiveness of preoperative testing for cataract surgery, they did not assess the visual and vision-related quality of life outcomes of cataract surgery. 

A commonly cited database study by Schein et al. (2) concluded that preoperative testing did not appreciably increase the safety of cataract surgery. But when you actually read this publication, it didn’t look at visual outcomes – which many would agree are of utmost importance to an ophthalmologist. Additionally, the majority of patients (64.3 percent) were ASA class I and II – the healthier end of the spectrum. Another study by Cavallini et al. (3) compared the incidence of ophthalmic and systemic complications in patients who were randomized into either preoperative testing or no testing, and reported no difference. However, as the preoperative characteristics in those two groups were not reported, it is not actually clear if the groups were similar or different in terms of physical status. Further, as the study also excluded patients taking anti-coagulation medications or insulin, ‘sicker’ patients were removed – and those are probably the very patients that need to be studied. 

Another paper by Chen et al. (4) reported that preoperative testing before cataract surgery occurs frequently – but is costly. This study is often referenced, but it didn’t actually look at perioperative or postoperative outcomes – neither systemic nor ophthalmic; it was basically a cost analysis. Because outcomes were not assessed, the utility of this study needs to be interpreted with caution. Unfortunately, it is a showcased study in a prominent journal – and insurance companies look to these kinds of articles when making policy decisions.

Ophthalmologists are under increasing economic pressure to streamline the preoperative workup of our patients, yet we lack data showing how systemic preoperative testing impacts outcomes. Ultimately, decisions on how we approach the preoperative workup – and surgery – should be based on those factors that have been proven to achieve the best outcomes for our patients. In the United States Department of Veterans Affairs (VA), outcomes data is of critical importance, and the VA is a leader in this area. To analyze the relationship between systemic disease and outcomes of cataract surgery, Mary K. Daly, Chief of Ophthalmology at VA Boston, along with her colleagues at other VA sites across the US, evaluated the relationship between ASA class and postoperative outcomes through a retrospective review of the ophthalmic surgery outcomes database (OSOD) (5). The OSOD project was designed to assess and enhance the quality of cataract surgery, and contains data from almost 5,000 cases at five Veterans Affairs centers; the data includes ocular and systemic comorbidities, visual acuity, and vision-related quality of life. Their analysis showed that cataract surgery improved visual acuity and vision-related quality of life in all patients, but outcomes were lower in patients with a higher ASA class (III and IV). Moreover, intraoperative floppy iris syndrome, iris prolapse, corneal stromal edema, clinically significant macular edema and postoperative hospital admission within 30 days were unanticipated perioperative events seen more often in patients of higher ASA class. A higher ASA class was shown to increase the risk of clinically significant macular edema and admission to the hospital postoperatively. Eight patients died within 30 days of surgery, all of whom had higher ASA classes. The research group identified a significant association between a history of chronic obstructive pulmonary disease (COPD) and 30 day postoperative mortality (all cause death after cataract surgery). Patients with COPD can be fragile, and further research to help optimize them for elective, but potentially life-changing and vision-restoring surgery, is required.

Why are these results timely and important? Having this information can help determine levels of risk, properly inform patients, help set reasonable expectations and maximize outcomes by minimizing those risks. We should offer patients the level of care needed to give them the best chance at a great outcome. That level of care (e.g., extent of preoperative testing, type of anesthesia) may vary depending on the patient’s systemic and ophthalmic comorbidities, and it is critical to provide valid research in this area which prevents insurers from enforcing blanket ‘one-fits-all’ policies which are essentially denials of payment. 

The important work of the ophthalmologists in the United States Veterans Affairs might be limited in terms of its retrospective design and demographic, but it is a jumping board. The protocols and reimbursement levels for preoperative testing and assessments by physicians in the US for visual restorative cataract surgery are extremely variable, and there is much we can gain on this topic, not only for the benefit of our patients, but for insurance companies. There might be a lot of economic pressure, but more studies looking at stratification of risk for patients based on their underlying health issues and comorbidities are needed to drive policy and practice decisions. It can be a challenging area to study, but our surgical colleagues – particularly cardiothoracic surgeons – are very good at looking at morbidity and mortality, and complications relevant to their procedures. Indeed, there exists a large corpus of literature pointing to systemic risk factors that influence postoperative outcomes for their patients. 

Ophthalmology is following suit, but much more work needs to be done, to gather and analyze data that evaluate the relationships between systemic disease, anesthesia requirements, and vision-related outcomes of cataract surgery. The vision and quality of life of our patients depend on it. The Veterans Affairs in the USA is advocating and leading the way.

The views expressed in this report are those of the authors and do not necessarily reflect the position or policy of the United States Department of Veterans Affairs or the United States government.