WASHINGTON WATCH

Patient Health and Safety Comes First: Office Cataract Surgery Should Not Be An Option

BY MICHAEL A. ROMANSKY, JD AND JEFFREY WHITMAN, MD

In the May 1977 issue of Nation’s Business, former Office of Management and Budget Director Bert Lance, coined the phrase “if it ain’t broke, don’t fix it.” For decades, cataract surgery has been one of the success stories in medicine, with an extremely high success rate and a significant impact on the daily lives of patients that is virtually unparalleled.

These very positive outcomes are a direct result of these surgeries having been performed by excellent and innovative surgeons in the highly regulated settings of the hospital and ambulatory surgery center (ASC). A recent survey of Outpatient Ophthalmic Surgery Society (OOSS) members and nonmember ASCs confirms that virtually all facilities are Medicare certified; 85% are accredited by a CMS-approved agency; and 81% are licensed by their states as ASCs.

For reasons difficult to comprehend, the Centers for Medicare and Medicaid Services (CMS) recently issued a Request for Information regarding the advisability of providing a facility fee for cataract surgery performed in the physician’s office. For OOSS, the response is clear and unequivocal: This is a bad idea that, if implemented without adequate regulatory oversight and safeguards, potentially threatens the health and safety of our patients.

CMS Assumptions Are Flawed

CMS states: “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 HOPD.” It is true that complications such as TASS, endophthalmitis, unplanned anterior vitrectomies, a dropped lens nucleus, a choroidal bleed, as well as systemic events such as a cardiac arrhythmia, myocardial infarction, or CVA do not occur frequently. However, when they do occur, they are life- and vision-threatening. Importantly, despite the meticulous care and preoperative assessment provided by the surgeon, anesthesiologist, and professional clinical staff, it is generally unknown in advance whether such a complication is likely to take place.

In January 2000, The New England Journal of Medicine published a study examining the efficacy of routine preoperative medical testing of cataract patients with respect to which providers completed brief medical history forms for documentation of coexisting conditions presented by the patients. In August 2015, OOSS, in coordination with the Ambulatory Surgery Center Association and the Society of Excellence in Eye Care, engaged 170 ophthalmic ASCs in a comorbidity study to randomly sample the H&P records of 50 of their most recent cataract cases; the sample totaled 8,500 cases, representing a total annual case volume of more than 400,000 cases, equaling about 13% of the nation’s annual cataract volume.

In essence, we discovered that there are very few “routine cases in patients with no comorbidities.” Regarding patient age, 76% of the patients in the NEJM study and 55% in the OOSS study were older than 70 years of age. In 2000, 76% of cataract patients presented with at least one comorbidity, while in 2015, only 6% of our patients presented with no coexisting conditions. The OOSS survey also demonstrated that 69% of our patients are taking five or more medications.

Potential Cost-Savings Offset by Risk to Patients

Although an office-based surgical environment may offer the potential for reduced costs to the Medicare program, the overwhelming majority of cataract patients present comorbidity profiles that warrant the rigorous attention to patient health and safety inherent in the federal regulations that govern the initial design and ongoing operations of hospitals and ASCs. These include detailed rules pertaining to infection control, environment, anesthesia, nursing, governance, and supervision.

These standards, and the hospital and ASC industry’s adherence thereto, are reflective of a well-established mindset in Medicare-certified and state-licensed ASCs (and hospitals) of commitment to patient health and safety and appropriate and regular oversight and enforcement by governmental and accreditation organizations. The aging cataract populations that our member surgeons treat are entitled to the most optimal surgical care and the safest surgical environments. The Medicare ASC Conditions for Coverage (CfC) provide a comprehensive framework for appropriate regulation of safe and appropriate surgical settings. It is ironic that federal regulators have recently augmented (we believe, unnecessarily) the standards for sterilization in the ophthalmic ASC at the same time they are considering promoting cataract surgery in the office where no infection control standards presently exist. Let’s be straightforward about one point: the physician’s office surgical suite is not at present rigorously regulated by any of the states.

Prerequisites to Facility Payments for Office Surgery

OOSS and the ASC (and hospital) communities believe that consideration of providing payment incentives for office cataract surgery is ill-advised, premature, and should be deferred until such time as CMS:

1. Further considers the health and safety risks to cataract patients who might be treated in offices rather than ASCs or hospitals.

2. Develops standards of care for office surgical suites that are comparable to those applied to ASCs with regard to protection of the health and safety of Medicare beneficiaries.

3. Identifies a model for the appropriate regulation of office-based surgical facilities and the enforcement of health and safety standards. State office surgery regulatory programs, where they even exist, are inconsistent and inadequate to protect the patient. OOSS believes that if CMS is to advance payment incentives for the performance of cataract surgery in the office, the agency should establish a federal program comparable to that established for ASCs.

4. Implements a pilot or demonstration project in limited geographic areas so quality of care, patient health and safety, and payment in the office cataract facility can be adequately evaluated.

The contemporary cataract surgery operating room is a comprehensive, high-tech environment, housing phacoemulsification equipment (with or without femtosecond lasers), operating microscopes, delicate surgical instruments, as well as sterilization systems that have been designed and validated for the ophthalmic micro-surgical setting.

The modern ASC meets stringent HVAC and airflow regulations and a requirement for emergency backup power. Will CMS require the same of office surgical facilities?

OASC staff members are trained in the intricacies of ophthalmic care and the use of this specialized equipment. Registered Nurses are required in ASC and Hospital ORs. Will the same be required of the office-based facility? The surgeon, anesthesia professionals, and clinical staff direct their attention to emergent care needs, including patient monitoring equipment, medical gases (e.g., oxygen), crash carts, defibrillators, and all other airway and medication requirements — requirements that carry a significant capital investment. Will the surgeon operating in his office commit to this initial and ongoing reinvestment?

The nation’s 5,400 ASCs, at least half of which perform cataract surgery, were never — nor should have been — offered a shortcut to Medicare certification and reimbursement, particularly with respect to patient health and safety issues.

No Change Needed

As ophthalmologists and ambulatory surgery centers, we have pioneered a revolution in the treatment of cataract patients. There is little that needs to be changed in the delivery of ophthalmic surgical care when our patients are provided the highest quality care with exceptionally good outcomes at a reasonable cost in a patient-centered, convenient, and overwhelmingly safe environment. It ain’t broke, so there’s nothing to fix. Our patients’ health and safety must come first. ■