CLEARANCE

Clearance. Medical clearance. Preoperative clearance. Surgeons request patients to be cleared for procedures, and they specifically want that word clearance. What does this mean? Does it imply that one is attesting that there is no risk of complications from anything that they do, or that, if something happens, the liability will fall upon the person who “cleared” the patient? We know that this is not so because unexpected and untoward outcomes can happen, even in the best scenarios, and we do not have that crystal ball to predict those.

As general internists who see patients requiring preoperative assessment, we take pride in practicing evidence-based medicine. Patients often bring in a form provided by the surgeon’s office. These forms are varied, often requesting specific testing that is unique to the surgeon or practice, not based on published guidelines. Some forms espouse outdated recommendations—the “ACC/AHA guidelines suggest that preoperatively administered beta blockers reduce perioperative ischemia and may reduce the risk of MI in high-risk patients.”¹ Many of the forms are almost threatening—“PATIENT WILL NOT HAVE SURGERY IF THIS FORM IS NOT FAXED BY 48 HOURS PRIOR TO SURGERY” and “MUST USE THE WORD CLEARANCE” in all caps. And almost all of them ask for labs that are redundant—a SMAC-20 and LFT’s?—or unnecessary and not indicated. Clearly these forms do not reflect current evidence—is anyone even looking at them? Rather it is merely the process to have the form completed that becomes the goal. And the same form/process for everyone? A healthy 28-year-old going for arthroscopic knee surgery, a 68-year-old with ESRD on dialysis going for TURP with the same requirements? Surely this is not evidence based.

Many patients come one or two days prior to their scheduled procedure, not enough time to optimize the patient, if indeed that was truly the reason for the visit. If there actually was an intervention that might lower a patient’s pre-operative risk—is one day enough time to do so? No, the day prior is fine, because it’s just a formality, the goal being to get the form to the surgeon’s office by…. well you get the idea.

The biggest offender is the “medical clearance” for cataract surgery, a 20-minute, ambulatory, bloodless surgery, using only topical anesthesia and no sedation, that has an exceedingly rare risk of non-ophthalmologic complications (0.014% mortality risk).² Despite many patients undergoing cataract surgery are elderly with co-morbidities, there are very few conditions that preclude them from undergoing this procedure, which incurs little physiologic stress. We have more than 20 years of evidence³ attesting to the disutility of preoperative assessment for patients undergoing cataract surgery. Now, we have data suggesting that all this does is delay a procedure needed by elderly patients who cannot see, and in the interim may have falls, possibly with fracture, and additional adverse events such as MVAs, further cognitive decline, and increased mortality,⁴ all while awaiting “clearance.” Indeed, the 2021 Society for Ambulatory Anesthesia position statement recommends that cataract surgery not be postponed in the absence of a severe acute medical illness.²

A recent patient who underwent pre-operative assessment was then told that her “clearance” expired five days prior, and she required an updated assessment. Was it 30 days? 60 days? What is magical about any of those time frames? If everything was normal prior, what is the likelihood that a new abnormality will emerge? And then there is the known “care” cascade of abnormal testing, resulting in repeat testing, follow-up imaging and visits, etc., with low rates of utility, and great potential for harm. The Centers for Medicare and Medicaid Services (CMS) has dropped the requirement for a history and physical examination before ambulatory surgery, recognizing the lack of benefit of routine testing for these patients.

This is far from patient-centered; this is patient-onerous. Why are we still doing this? One answer may be the potential for lost revenue with streamlining the process and eliminating inefficiencies. Since there are about 1.5 million cataract surgeries performed annually in the United States, this is a very lucrative process for any health system as it generates visits, tests, and interventions. A 68-year-old man with atrial fibrillation, hypertension and obstructive sleep apnea may be asked to undergo “clearance” from cardiology, pulmonary and primary care, even for a simple orthopedic procedure performed without general anesthesia. By participating in this process, we are not serving our patients, but serving the system. But by not participating in this process, we may be depriving our patients of procedures that greatly improve their quality of life. What a dilemma.

So, is there any value in doing a pre-operative assessment? Absolutely. These visits should be viewed as an opportunity to bring patients into care who might not otherwise come. These patients may be more motivated to address and improve health habits in the preoperative period (e.g., smoking cessation). Presurgical care can be looked at as a chance to potentially mitigate poor outcomes, address unstable or non-optimized medical conditions to prevent increased length of stay, infection, and readmissions.⁵ This is possible if we are given adequate time prior to the surgery. In addition, all patients can benefit from a good medication reconciliation, a discussion of their health risks, and ways to improve their health. Optimally, this process should be individualized and tailored to the patients’ needs—if they have multiple co-morbidities or take multiple medications. The process should never be automated, since one size does not fit all, and many patients can forego the process safely.

CMS may finally be changing their reimbursement policy for unnecessary and non-essential preoperative testing. From the CMS 2023 Final Rule: …the medical necessity for the clearance must be evident. The necessity is determined by the scope and potential risks of the procedure itself, along with the patient’s general state of health and possible risk factors. For a patient with a chronic, stable condition(s) who is undergoing a surgical procedure which is not inherently associated with high risk (e.g., cataract surgery), a preoperative clearance may not be medically necessary. Thus, a financial disincentive may have more impact than years of available evidence. Perhaps it is this disincentive that will finally allow us to deliver evidence-based care to our preoperative patients.