From the Hill

Where Do ASCs Stand on the Hill?

By Michael A. Romansky, JD

As Counsel to the Outpatient Ophthalmic Surgery Society (OOSS) for almost three decades and a diehard advocate for ASCs, I've been accused of viewing the ASC as the hub of the U.S. healthcare delivery system. While that's not quite the truth, I do become frustrated with our public policymakers' inability or unwillingness to see the potential for our centers to improve beneficiary access to and quality of health care, while at the same time reducing the burgeoning costs of surgical care.

The focus of the nation, when it comes to health care, is on whether the landmark healthcare reform legislation, enacted barely 2 years ago, will be decimated, torn piecemeal or left untouched by the Supreme Court. The attention of most medical providers is glued to the byzantine and seemingly endless path toward resolution of the sustainable growth rate problem. The ophthalmic ASC, which conserves hundreds of millions of dollars per year in Medicare dollars, and the patient, who pays hundreds of dollars less for the cataract, YAG or retina facility copayment, is left relatively unprotected when compared with the gargantuan hospital and medical lobbies.

ASC Industry Success in Washington

Yet, the ASC industry and its ophthalmic segment of nearly 1,000 facilities has managed to have a positive impact on a multitude of issues that impact ASC quality, costs and access:

How is it that, as professional fees have declined year after year, ASC facility fees have gradually risen or remained stable?

How is it that the ASC community has beaten back efforts by CMS to curb payment rates or restrict the range of services that can be performed by surgery centers or by the hospital industry to prohibit physician ownership of ASCs?

How has our industry, small as it is, managed to successfully reverse inane and irrational policies, such as prohibiting a surgeon from performing a YAG on the same day the patient was referred to the ASC? How has the ASC community managed to favorably impact the rules encompassing the new Medicare program that forces facilities to report quality and outcomes data on its patients?

First and foremost, the ASC product is an excellent one. Second, our lobbying and research efforts — OOSS, the ASC Association, the ASC Quality Collaboration, with big assists from surgical specialty groups like the AAO and ASCRS — have a razor-like focus on legislative and regulatory issues that are critical to the interests of the patient and facility. Third, we benefit from the political and grassroots support of our memberships ... more on what we can do to help ourselves later.

In just the past 6 months, we've accomplished several important goals in a highly regulatory, budgetconscious environment: repeal of the strict limitation on same-day surgery; implementation of a quality reporting program that includes reasonable and achievable measures and standards; and, adoption of our highest ASC update in a decade.

As we approach the November elections and the days for legislative action dwindle on the Hill, it's an appropriate time to restate where the ASC community ? and ophthalmic centers in particular — stands with respect to our major priorities in the Nation's Capitol:

Payment Issues

In early July, CMS will publish its ASC payment proposal for 2013. Because of statutorily imposed budget neutrality restrictions, we don't expect base rates for ASC services to change dramatically. In fact, because Congress failed to meet the Budget Control Act reductions of $1.2 trillion in federal spending, providers (including ASCs) will be subject to a process called sequestration, under which these unrealized savings will be affected by across-the-board cuts of up to 2% after updates.

The ASC and ophthalmology communities will, once again, strenuously object to CMS’ use of the CPI-U as an inflator, urging instead that facilities be afforded the Hospital Market Basket, which is used for hospital outpatient departments and is typically about a point higher. The HHS Office of Inspector General (OIG) will conduct a study in 2012 of the “appropriateness of Medicare's methodology for setting ambulatory surgical center payment rates under the revised payment system.” We will raise our concerns with the OIG regarding the impact of cost-of-living differentials on the growing disparity in payment rates to ASCs and hospitals.

Policymakers are also taking an interest in documented reports that hospitals are acquiring ASCs and converting them to HOPDs (enabling them to bill for surgical services at the higher hospital rates). For more information on this topic, see the May issue of the Ophthalmic ASC online.

Finally, as a failsafe, the ASC community continues to garner support for The ASC Quality and Access Act – with 50 co-sponsors in the House and seven in the Senate — legislation that would mandate that facilities receive the same annual update as hospitals and require CMS to enact several other vital reforms to the Medicare ASC program.

ASC Quality Reporting

In what is arguably the most significant new regulatory challenge of the past quarter-century, commencing October 1, 2012, CMS will require ASCs to report quality data or be subject to penalties. The key components of the Quality Reporting Program are as follows:

ASCs will be required to report on five claims-based measures during the reporting period October 1 through December 31, 2012 in order to avoid a 2% update in payments in 2014. Data submitted in CY 2013 will impact updates in payments for 2015. The measures requiring reporting: Patient Burn; Patient Fall; Wrong Site, Side, Patient, Procedure, Implant; Hospital Admission/Transfer; and, Prophylactic IV Antibiotic Timing. Because ophthalmic ASCs do not use IV antibiotics for prevention of surgical site infections, OOSS, AAO, and ASCRS are strenuously urging CMS to exempt eye facilities from this reporting requirement.

When patients do not experience any of the adverse events encompassed by the four applicable measures, the ASC may report with a single g-code (G8907) rather than having to report on each measure separately.

Any ASC that is a Medicare-participating facility as of January 1, 2012 will need to begin reporting October 1, 2012 to be eligible for full Medicare updates in 2014.

CMS has made a significant change in implementation of a requirement that facilities use a safe surgery checklist in 2012. Originally, ASCs would have been required to certify that such a checklist was in place on January 1, 2012. The Manual clarifies that ASCs using a safe surgery checklist at any time during 2012 can respond with “yes” when reporting its use of the checklist to CMS. The ophthalmology community has developed a guidance ophthalmic safe surgery checklist that can be adapted by eye centers depending upon their patient and procedure mix; this checklist is available at www.OOSS.org.

The use of quality data codes on an ASC's claims will indicate that a facility is participating in the QR program; the facility doesn't need to provide notice to CMS.

The program establishes a completeness threshold of 50%, which means that ASCs will be considered successful reporters and not subject to penalties if 50% of their claims contain quality data codes. The threshold will increase in the future.

CMS won't seek to validate what ASCs report through record review or any other means beyond the usual Medicare contractor processes.

An extension/waiver process will be available to ASCs that are unable to report quality data due to extraordinary circumstances.

While CMS continues to state that “any and all” data could be made public, the agency has not specified what data will be used for public reporting.

Facilities will be required to designate an individual to serve as the Center's QualityNet administrator, the person who will serve as point of contact between the facility and the Quality/Net website. ASCs will use this website to report data on their use a safe surgery checklist (2012) and the surgical volume they manage beginning in the summer of 2013, at which time the administrator will have to be in place.

Facility Certification

No development in Washington has generated more confusion and aggravation over the past 2 years for ASCs than the revised Medicare ASC Conditions for Coverage (CfC), issued in 2009. The most arbitrary and capricious of the rules required patients to receive notice of their rights at least 1 day in advance of a surgical procedure, effectively prohibiting, except under narrow circumstances, a patient from receiving surgical care in an ASC on the same day that the surgeon refers him to the facility. The rule has had the onerous effect of precluding same-day diagnosis for, and performance of, Yag procedures, much to the inconvenience of beneficiaries and consternation of surgeons.

After 2 years of intensive advocacy by OOSS and the ASC and ophthalmology communities, the White House and HHS announced that this regulation was being withdrawn as one of many that were “unnecessary, obsolete, or burdensome … to American hospitals and healthcare providers.” CMS has also clarified that notice of patient rights may be provided on the same day of surgery, so long as it's prior to the start of the surgical procedure.

CMS also issued a final rule eliminating the specific list of emergency equipment ASCs must have on hand and has allowed facilities, in conjunction with medical staff and their governing bodies, to develop policies and procedures that specify emergency equipment appropriate to the services they provide. Despite these victories, there remains a plethora of CfC-related challenges as ophthalmic ASCs face new and sometimes ambiguous and inconsistently applied standards.

Drug Shortages

A recent survey of by the Association of Ambulatory Surgery Centers concluded that almost 90% of facilities are experiencing weekly drug shortages and more than 80% were never provided advanced notice of the lack availability of the products, mostly IV anesthetics. Similar shortages are being reported by hospitals. Although there are a number of factors contributing to the shortage, one significant problem is a CMS regulation that prohibits multiple use of vials that have been labeled for single use, the consequence of which is disposal of perfectly good product.

OOSS has joined the broader ASC community in lobbying CMS to alter its policy and permit multiple use of single-use vials. We're also supporting several pieces of federal legislation that would ameliorate the national drug shortages problem. For example, in May, both the House and Senate passed FDA reform bills that would require drug manufacturers to notify HHS of discontinuances or other interruptions in the supply of important drugs; require FDA to maintain a drug shortage list; require FDA to expedite reviews of applications for approvals of drugs verified to be in shortage; and, require the Comptroller General to conduct a study examining the causes of shortages and provide recommendations for preventing shortages in the future. ◊