EYE ON OOSS

The Virtue of Withholding Judgment

BY KENT JACKSON, PhD, EXECUTIVE DIRECTOR of OOSS

In July, CMS published its annual physician’s payment rule, which appears to defer consideration of providing a facility fee for office cataract surgery. As expressed by Mike Romansky, OOSS Washington Counsel, in his Washington Update released via OOSS on July 7, this was an important milestone in what he refers to as “our most important regulatory priority.” Adding that “we will be aggressive and zealous in safeguarding the interests of our patients and our centers.” This Washington Update set a new OOSS record for email responses from our members, and a number of media sources were quick to pick it up.

It might seem a stretch to compare the global economic and geo-political implications of Brexit with our concerns about the CMS-prompted issue of office-based cataract surgery. But allow me to boldly assert that there are parallels worth considering.

Following the Brexit vote, New York Times columnist Mark Leibovich extolled the virtue of considering both the “predictive” (near-term) and “instructive” (long-term) implications of Brexit before rendering judgment or taking decisive action. It reminded me of a lecture by one of my philosophy professors in which he concluded that the theoretical basis for advanced human learning is predicated on the aptitude to “withhold judgment until comprehension is complete.”

The immediate response to the Brexit vote was largely driven by an emotional reaction to the predictive. Those who voted to stay were shocked and dismayed; those who voted to leave were celebratory. Then, as reality set in, a more measured and instructive response began to take shape. Similarly, the CMS issued its Request for Information in July 2015, suggesting the possibility of payment of a facility fee for cataract surgery performed in the office setting. The reaction of the ophthalmic and ASC communities was immediate and emotional, keying on the predictive. As rationale for its request, CMS stated, “We believe that it is now possible for cataract surgery to be furnished in an in-office surgical suite, especially for routine cases … in patients with no comorbidities.” It was a strong signal that a very consequential policy shift could be in the making.

However, of all the input received in response to CMS — and our Washington counsel read every comment — the position ultimately taken by OOSS was the most comprehensive of all. As Romansky wrote in the May 2016 issue of The Ophthalmic ASC, “From the OOSS perspective, there is a clear and unequivocal response: This is a bad idea that, if implemented without adequate regulatory oversight and safeguards, potentially threatens the health and safety of patients.” As the article further describes, OOSS has prescribed four cautionary considerations that should be addressed before implementing a payment policy for cataract surgery in the office setting:

• Further study of the patient health and safety risks involved;

• Development of standards of care for office surgery comparable to the standards for ASCs;

• Identification of a model for regulation and enforcement of standards; and

• With the above in place, implementation of a demonstration project to evaluate quality of care, patient health and safety, and payment considerations.

OOSS developed these points, with patient health and safety as core to each, after surveying OOSS member ASCs to get a clear and quantifiable picture of the presenting health profiles of their cataract patients. We sought to fully understand just who and how many patients might truly fit CMS’s definition of a “routine case.”

With the input of our OOSS leadership, including highly credentialed surgeons, operating room nurses, physician assistants, and anesthesiologists, we sampled cataract patient profiles nationwide, relying on the responsiveness and reporting capability of OOSS member centers across the U.S. We launched the survey in September and had received 170 responses by the end of October — just as the final OOSS response to CMS was being prepared. (See “OOSS Cataract Patient Profile Survey” below.)

Survey Findings

First, who is the CMS-described “routine cataract patient?” The OOSS survey identified a cataract patient population that is largely older than 70 years old, suffers from multiple comorbidities, and takes numerous prescription medications — in short, a medically fragile population. More research likely will bear out these findings — identifying and quantifying the health status of the vast majority of cataract patients and the causal links between patient profile characteristics and the occurrence of complications or other influences on surgical outcomes. Once we have a complete and accurate picture of the “typical” cataract patient population, only then can we reasonably explore appropriate standards, models for regulations and enforcement, and develop well-framed pilot projects.

Kaiser Permanente recently conducted a study of cataract surgical outcomes for patients treated in three of its minor procedure rooms (MPRs), all of which were located in suburban Denver. Although the Kaiser study provides useful information, it was very limited, and is not applicable to the typical office setting used as a surgical site or the typical cataract patient.

Kaiser performed its study in suburban, corporate-managed care MPR environments, which are by far more uniform, controlled, and regulated than most physicians’ offices, which vary widely throughout the country. Consider the ramifications of this very unequal comparison of “office setting” as it relates to standards, regulation and oversight of people, processes, and facilities in a variety of urban, suburban, small town, and rural settings.

Also, these Kaiser facilities primarily serve patients from the Denver suburbs, where residents are generally more affluent and healthier than the national average. The reported systemic comorbidities of patients in the study were limited to hypertension (53.5%), diabetes (22.3%), and pulmonary disease (9.4%). These comorbidity rates are much lower than those found among patients in the OOSS survey and do not account for other comorbidity factors included in the OOSS survey. You see the problem.

Gut Reaction

As suggested by Brexit, it is wise to respond to the predictive possibilities of any emerging idea or issue, just as OOSS has done. It is equally important to measure any response by considering the relevant information and consequences — withholding judgment until comprehension is complete. We appreciate that CMS apparently is doing just that on this important issue. ■