WASHINGTON WATCH

ASC Quality and Patient Safety — The New Regulatory Horizon

BY MICHAEL ROMANSKY, ESQ.

In the last issue of the Ophthalmic ASC, we focused on ASC payment issues. In this article, we turn to the expanding array of government endeavors to ensure that patients are afforded high-quality care in the outpatient surgical environment.

The ASC industry has an exemplary record of providing surgical services in a cost-effective, patient-centered and accessible way. Infection and complication rates are infinitesimally low. Patient satisfaction rates are astronomically high. Yet there is little data to corroborate what ASCs and ophthalmologists know to be a reality — that the care provided in the ASC is of optimal quality, equal to or higher than that of the hospital. And in the absence of such data, our facilities can find themselves subject to burdensome and unnecessary regulation that can be costly, stifling innovation and actually impeding the delivery of quality care to patients. In this issue, I’ll explore two important and contemporary issues – Medicare ASC quality reporting and ophthalmic ASC sterilization policy.

Quality Reporting in the ASC – the Good, the Bad, and the Ugly

The Beginning

A half-decade ago, CMS proposed its first ASC measure. It was cataract specific, and it was a doozy. Developed by a CMS contractor with nary the input of an ophthalmologist, the measure would have required hospital outpatient departments and, ultimately, ASCs, to determine whether a patient scheduled for cataract surgery would achieve a 20% improvement in vision, and, if not, disallow the procedure. This measure, of course, had little to do with quality; rather it was a bold and crude attempt to reduce cataract surgery utilization and assign to the ASC the role of enforcer. Upon vociferous objection by OOSS, AAO and ASCRS, the measure was quickly withdrawn, but some of the more recently proposed quality measures, while less clumsy, incorporate similar flaws.

In 2012, CMS launched the ASC Quality Reporting Program in earnest. Most of the measures adopted were developed by the ASC Quality Collaboration (on whose Board of Directors OOSS sits) and endorsed by the National Quality Forum. They included: wrong site, patient, procedure, implant; hospital transfer; and patient burns and falls. While it could be debated whether these measures provide useful information to consumers, the ASC industry is doing its part — a remarkable 98+ percent of ASCs are in compliance with reporting requirements!

Ophthalmology-specific Measures

While quality reporting hasn’t posed a particularly burdensome exercise to date, the ophthalmology and ASC communities have been extremely concerned with CMS initiatives to transition from process- to outcomes-based measures that focus on cataract surgery. To date, CMS has proposed several — very misguided, we believe — ophthalmic measures, including reporting on (1) Complications that occur within 30 days following cataract surgery that require additional surgical intervention, and (2) Improvement in Patient’s Visual Function Within 90 days Following Cataract Surgery.

OOSS, the Ambulatory Surgery Center Association (ASCA), AAO and ASCRS have vehemently objected to all of the ophthalmic measures proposed to date by the government. Why? They fail to meet what we believe are the foundational criteria for facility-level quality reporting measures in the ASC. Any ASC quality measure should:

• Relate to an episode of care that occurs within the confines of the ASC

• Encompass data that is available within the ASC

• Be collectible by the ASC staff, and

• Generate conclusions that are actionable by the facility, thereby enabling the ASC to potentially improve the quality of care offered to its patients

The good news is that CMS has withdrawn some of the problematic eye guidelines and has determined that the rule mandating that the ASC report a cataract patient’s visual function within 90 days of surgery will be voluntary, meaning that facilities need not report at all.

The Best Defense is a Good Offense

Let’s be clear, though — the government is clearly intent on devising and implementing measures relating to high-volume services and specialties such as ophthalmology. 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 have decided to develop our own measures that meet the aforementioned parameters, which are not unduly burdensome, and will potentially generate meaningful data for consumers. To date, our organizations have recommended that three ophthalmic measures be considered for adoption for ASC quality reporting purposes:

• Unplanned anterior vitrectomy in cataract surgery patients. This measure has been endorsed by the ASC Quality Collaboration and approved by the Measures Application Partnership. It may be proposed by CMS in the ASC payment rulemaking this summer.

• Incidence of toxic anterior segment syndrome (TASS) in cataract surgery patients.

• Incorrect intraocular lens implantation in cataract surgery patients.

These incidents are well supported by the clinical literature. 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. Moreover, they would serve as in important complement to the outcomes measures already being reported through the Physician Quality Reporting System.

Sterilization of Ophthalmic Instruments in the ASC – Confusion and Clarification

This past fall, OOSS reported that CMS had issued an update to the Medicare ASC Conditions for Coverage mandating that immediate use steam sterilization (IUSS) could no longer be used in the ASC on a routine basis. Such a policy appeared to require ASCs to utilize terminal sterilization units and perhaps acquire many more sets of instruments. In response, OOSS, ASCRS, and the AAO met on two occasions with the agency to express our concerns about the new policy, focusing on educating CMS staff regarding the etiology of TASS and endophthalmitis and to provide the results of a recent survey of ASCs of their current sterilization and instrument-cleaning practices.

Our efforts have resulted in the agency’s further clarification that the practices of most ophthalmic ASCs should be in compliance with its rules governing instrument sterilization. What are the key elements of the new policy?

• CMS believes that the term “immediate use steam sterilization (IUSS)” reflects the process formerly referred to as flash sterilization. “IUSS is the term currently accepted to describe the process for steam sterilizing an instrument that is needed immediately, not intended to be stored for later use, and which allows for minimal or no drying after the sterilization cycle. IUSS is not acceptable for use as a routine method of sterilization.”

• The agency is defining short cycle as a “form of terminal sterilization that is acceptable for routine use for a wrapped/contained load where pre-cleaning of instruments is performed according to manufacturers instructions for use (IFU), includes use of a complete dry time and is packaged in a wrap or rigid sterilization container validated for later use.”

We’re expecting confusion in the trenches as surveyors apply the updated policy. Please contact OOSS if your facility is cited for deficiencies related to your sterilization processes.

What’s a Progressive Ophthalmic ASC to Do?

Over the course of these two articles, we have discussed a plethora of legislative, regulatory and payment developments that embody the potential to impact the ophthalmic ASC. It’s also important to appreciate just how effective OOSS — working with you, our grassroots advocates, and with other ophthalmology and ASC organizations — has been in securing relief from intrusive regulation and proposing solutions that work! How do we maintain — in fact, accelerate — our progress in meeting the challenges emanating from regulators at the federal and state levels and from the market place? I would offer a few suggestions:

• Join the Outpatient Ophthalmic Surgery Society. It starts and ends with a strong and vibrant OOSS. Check us out at: www.OOSS.org.

• Educate Your Elected Officials. As healthcare providers, we accomplish our legislative and regulatory objectives by educating policymakers about the benefits of innovative ophthalmic surgical care and the quality, convenience, and cost benefits of ambulatory ophthalmic surgery. OOSS, through our website’s Advocacy Center, will provide you with all of the tools to develop a relationship and convey an effective message with just a few keystrokes.

• Contribute to OOSPAC. The Outpatient Ophthalmic Surgery Political Action Committee (OOSPAC) is the only PAC whose sole purpose is to advance the interests of surgeons who own and/or practice in ophthalmic ASCs. ■