On March 2, 2018, the front page of USA Today had as its lead banner: “How a Push to Cut Costs and Boost Profits at Surgery Centers Led to a Trail of Death.” We’ve seen these stories before — anecdotal, biased, without context, and inflammatory. The ASC industry responded immediately, pointing out that the story focused on a small number of tragic errors, while ignoring the overwhelming beneficial outcomes, thereby creating a false and misleading narrative about the safety and effectiveness of surgical care provided in the ASC setting.

What followed is something I have not observed in my 35 years representing the Outpatient Ophthalmic Surgery Society and other ASC groups. The story garnered virtually no further traction in the print, TV, and social media and no reaction from Capitol Hill or CMS.

Why the tepid reaction? I believe it is because the fruits of the efforts of OOSS, the ASC community, and medical communities to educate patients, policymakers, and media about the benefits of ASCs are finally being realized. The nation’s ophthalmic ASCs are committed to providing Medicare beneficiaries with access to the highest-quality surgical care while lowering their cost-sharing obligations and assisting the Medicare program in the containment of health expenditures. There is greater recognition because legislators and regulators are searching for meaningful healthcare reform — improving quality and access, while reducing costs — and ASCs have the potential to be a significant part of the solution.

When the world thinks about healthcare policy, the focus is on the “big issues” — repeal of Obamacare, reforming entitlement programs, and reducing Medicare and Medicaid by over a trillion dollars by virtue of mandates in the recently enacted tax bill. Predicting how these issues will be resolved is well above my pay grade. However, I do believe that these complex issues and corresponding scenarios will have little impact on the legislative and regulatory matters of concern to our ophthalmic surgery centers. The legislative and regulatory issues that affect the ASC industry are not typically adjudicated by the White House or the Speaker of the House of Representatives. Our battles are gutted out in the middle-upper levels of the Centers for Medicare and Medicaid Services (CMS) with a handful of key senators, representatives, and staffers who — by virtue of their positions, the influence of their constituents on ASC issues, or their genuine interest in the many benefits offered by surgery centers — have become our advocates.

Let’s drill down and focus on the priorities of OOSS and the strategies that will enable our centers to thrive in this increasingly regulatory and cost-conscious environment. One major caveat: with the ebb and flow of events in the nation’s Capitol, rest assured we will face a multitude of issues that heretofore haven’t even been on the horizon.

Sterilization Practices

Despite the exceptional record of ASCs in providing vision-restoring surgical care to millions of Medicare patients each year with negligible infection rates, the ophthalmology and ASC communities continue to battle over appropriate infection control standards for ASCs. In 2014, CMS issued an update to the Medicare Conditions for Coverage mandating that immediate use steam sterilization could no longer be used to clean instruments. This appeared to require ASCs to utilize terminal sterilization units and likely acquire many more sets of instruments.

OOSS, ASCRS, and AAO embarked upon a comprehensive effort to educate CMS staff and the private standard-setting bodies, such as AORN, regarding the etiology of TASS and endophthalmitis, and the current sterilization and instrument cleaning practices of ophthalmic ASCs. We’ve made some progress:

• CMS has clarified that the cleaning and processing practices of most ASCs are acceptable, as long as we follow manufacturers’ instructions for use (IFU).
• We have persuaded a number of manufacturers to modify their IFUs to conform to our organizations’ guideline recommendation that enzymatic detergents not be used in cleaning surgical instruments.
• OOSS, ASCRS, and AAO have sponsored several studies by an independent laboratory regarding the efficacy of utilizing STATIM and STERIS sterilizers and developed guidelines.

As reported in Ophthalmology this spring, these studies demonstrated that “unwrapped, short-cycle sterilization that adheres to the IFU of these 2 popular, FDA-cleared sterilizers is appropriate for routine use in between sequential same-day cataract surgeries. With the STATIM2000, any moisture evaluated was found sterile if the unwrapped instruments are not completely dried, but are kept within the covered sterilizer cassette until needed and handled in the operating room for the subsequent case after some short delay. Ophthalmic instruments being processed and stored overnight for later use should be wrapped and completely dried, and our study showed no growth of the target organism for up to 7 days after the complete, wrapped terminal cycle.”

Our organizations’ processing guidelines and this article should provide valuable ammunition for facilities that face surveyors challenging their sterilization processes. It may also enable us to persuade organizations, such as AORN and the Association for the Advancement of Medical Instrumentation, to appropriately modify their sterilization standards to reflect our state-of-the-art ophthalmic guidelines.

Cataract Anesthesia Payment

In January, the Medicare carrier Anthem updated its clinical guidelines to require eye surgeons to assume responsibility for topical, local, or regional anesthesia, or conscious sedation for all cataract patients with very limited exceptions, [i.e., patients requiring complex surgery, patients unable to communicate or cooperate, or patients with histories of problems with anesthesia].

In a letter to Anthem, OOSS argued that the guideline “reflects a misguided view of the complexity of cataract surgery, the relative training and skill sets of the ophthalmologist and anesthesia provider, and the unique characteristics and health status of the typical cataract patient.”

OOSS pointed out that clinical literature and experience demonstrate that the presence of an anesthesiologist or CRNA represents the appropriate standard of care, and we were forthright in arguing that ophthalmologists lack the requisite training, experience, and expertise in sedation, physiologic monitoring, and treatment of non-ophthalmic medical problems. Anthem has backtracked and, at least for now, will not deny payment based on its ill-considered guideline. OOSS and the eye community are pressing for the guideline to be rescinded.

ASC Payment Rates

ASC payments are annually updated for inflation by the percentage increase in the Consumer Price Index for all Urban Consumers (CPI-U) less a multifactor productivity adjustment. For 2018, overall ASC payments increased by 1.2%. For the few facilities that have not met ASC quality reporting requirements, rates will have been decreased by 0.8% below 2017 rates.

OOSS and the ASC community will continue to urge CMS to update rates by the Hospital Market Basket, which is provided to hospital outpatient departments (HOPDs) and is typically about a point higher than the CPI-U. Because ASCs treat the same patients for the same conditions and consume comparable resources in delivering surgical care, there is no justification for ASCs to receive a lesser increase than hospitals.

As a failsafe, the ASC community has developed and is seeking passage of legislation, The ASC Quality and Access Act of 2015, that would direct CMS to provide ASCs with the same update as hospitals, and add an ASC voice to the Advisory Panel on Hospital Outpatient Payment, which is important because our rates are linked to HOPD payments, and require CMS to disclose the criteria it uses to determine which procedures may be performed in the ASC setting.

Office Cataract Surgery

Two years ago, CMS commenced an examination regarding the advisability of providing a facility fee for cataract surgery performed in the physician’s office. For OOSS, the response was clear and unequivocal: This is a bad idea, and, without adequate regulatory safeguards, could threaten the health and safety of our patients. OOSS has been the lone voice amongst major ophthalmology organizations to unalterably oppose treating cataract patients in the unregulated office setting. In its recent physician payment rulemaking, CMS was silent regarding payment for office cataract surgery. This is a positive sign that our message has been received; however, OOSS will remain vigilant in representing our members and ensuring that this ill-advised and imprudent policy never sees the light of day.

Leveling the Playing Field

Hospitals are paid about twice as much as ASCs to perform the same surgical procedures. Recent tax and budget bills will require policymakers to reduce Medicare expenditures by several hundred billion dollars in the years ahead. Reducing hospital rates to ASC levels is one of the few initiatives available to Congress with the potential to generate such significant savings. I believe that this policy will be seriously considered in 2019. Why should ASCs care about this development when our rates might not increase? It’s a volume proposition: services will undoubtedly migrate from the HOPD to surgery centers — many hospitals already are less than enamored about ophthalmic surgery, and this concern will be heightened if payment rates are substantially reduced.

ASC Quality Reporting

While quality reporting has not posed a particularly burdensome exercise for ASCs to date — remarkably, more than 98% of facilities are in reporting compliance — the ophthalmology and ASC communities have been concerned with some CMS initiatives to transition from process- to outcomes-based measures that focus on cataract surgery. Several CMS proposals have reflected little understanding of cataract surgery and of the operations of the ophthalmic ASC.

Fortunately, to date, we have quashed these injudicious endeavors by successfully arguing that they fail to meet what we believe are the foundational criteria for facility-level quality reporting measures in the ASC. Any ASC measure quality should:

• Relate to an episode of care that occurs within the confines of the ASC
• Encompass data that are available within the ASC
• Be collectible by the ASC staff
• Generate conclusions that are actionable by the facility, thereby enabling the ASC to potentially improve the quality of care offered to its patients
• Have been validity-tested in the ASC environment.

In sports parlance, OOSS believes that a good offense is a good defense. Increasingly impatient with the efforts of CMS and other agencies to develop and proffer reasonable and appropriate ASC quality measures, the ophthalmology and ASC communities are developing and testing our own measures that meet the aforementioned parameters, are not unduly burdensome, and will potentially generate meaningful data for consumers.

Indeed, CMS adopted for 2018 a measure proposed by OOSS, Unplanned Anterior Vitrectomy in Cataract Surgery Patients, and we are hopeful that the agency will approve a measure on TASS for 2020. These measure topics are well supported by the clinical literature, and we believe that measuring these events in the ASC and HOPD settings presents an opportunity to improve the quality of cataract surgery for Medicare patients receiving their care in the ASC. ■