AHA, HAP Amicus Brief on Concurrent and Overlapping Surgeries, November 1, 2021


Defendants have persuasively explained why the Complaint fails to state a claim as a matter of law. Amici do not seek to repeat those compelling legal arguments. Instead, amici can best assist the Court in another way: by providing critical information, based primarily on documents incorporated in the Complaint, about the history, practice, and regulation of concurrent and overlapping surgeries during the time period relevant to this case.

The practice first came to widespread public attention with publication of a Boston Globe article in October 2015. It spurred a number of inquiries, and was certainly a catalyst for the American College of Surgeons (ACS) to update its guidance on the practice, the Senate Finance Committee to issue a report on the subject, and hospitals across the country to review and update their internal policies governing those surgeries. But one key stakeholder, the Centers for Medicare & Medicaid Services (CMS), did not change its preexisting billing guidelines because those guidelines already properly deferred to the medical expertise of individual surgeons and their teams. Then and now, CMS’s billing guidelines correctly recognize that surgical teams perform a wide variety of medical procedures under widely differing circumstances, and so the guidelines appropriately defer to surgeons’ knowledge and on-the-ground demands. To that end, CMS’s Medicare Claims Processing Manual explicitly allows doctors to determine what portions of particular surgeries are “critical,” and permits overlapping surgeries to occur so long as a qualified backup physician is available. This has allowed hospitals to develop policies for concurrent and overlapping surgeries that are consistent with ACS guidance, and best suited to their patients’ individual circumstances and their surgical teams’ own professional experience.

Despite the flexibility and deference contained in CMS’s Manual, the United States Attorney’s Office now seeks to impose its own view of proper medicine over that of a world-renowned hospital and its surgical staff. But that is not the job of the Department of Justice. Nor is the function of the False Claims Act, which the Supreme Court has repeatedly explained “is not ‘an all-purpose antifraud statute,’ or a vehicle for punishing garden-variety breaches of contract or regulatory violations.” Universal Health Servs., Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989, 2003 (2016) (quoting Allison Engine Co., Inc. v. U.S. ex rel. Sanders, 553 U.S. 662, 672 (2008)). At the very least, it is CMS’s responsibility in the first instance as the expert agency that actually reimburses hospitals for medical services to develop meaningful guidance for concurrent and overlapping surgeries, if that guidance is needed. Only then, and only if CMS’s guidance is not adhered to, are False Claims Act lawsuits appropriate. But CMS has not developed such guidance, and that fact alone fatally undermines this Complaint. Simply put, DOJ-driven False Claims Act lawsuits cannot be used to regulate concurrent and overlapping surgeries in CMS’s stead.

More elementally, neither the Department of Justice nor the False Claims Act should be allowed to short-circuit the ongoing medical discussion about how to best ensure the efficacy and safety of overlapping surgeries. In light of the ACS’ updated surgical guidance, hospitals revised their policies on the subject and, in so doing, demonstrated that they are capable of effectively managing overlapping surgeries consistent with their own unique medical needs. Indeed, studies discussed in Section II below—including the Senate Finance Committee’s report, which is incorporated into the Complaint in paragraph 134—recognize that hospitals have taken varying approaches to overlapping surgeries since 2015. But contrary to implications in the government’s Complaint, CMS itself has stated that patients are not endangered by the practice. See Staff of United States Senate Finance Committee, Concurrent and Overlapping Surgeries: Additional Measures Warranted 4 (Dec. 6, 2016), https://www.finance.senate.gov/imo/media/doc/Concurrent%20Surgeries%20Report%20Final.pdf (“SFC Staff Report”) (“Both CMS and Joint Commission told Committee staff that in conducting oversight activities, they have not noticed the practices of concurrent or overlapping surgeries as contributing in any particular way to patient harm.”). In fact, experts have found that overlapping surgeries are not just safe, but they allow more patients to receive lifesaving care when it is needed. As the chair of surgical quality at the Mayo Clinic’s Rochester campus put it: “Our data shows that overlapping surgery as practiced here is safe.… We think [overlapping surgery] provides value to our patients because it allows more patients timely access to surgery and care by expert teams.’” Sharon Theimer, Study of thousands of operations finds overlapping surgeries are safe for Mayo Clinic patients, Mayo Clinic News Network (Dec. 1, 2016), https://newsnetwork.mayoclinic.org/discussion/study-of-thousands-of-operations-finds-overlapping-surgeries-are-safe-for-mayo-clinic-patients/.

In the end, as the history below makes clear, this Court must not allow one United States Attorney’s office to dictate important medical decisions through the threat of civil and criminal False Claims Act liability for a surgical practice that CMS has not deemed harmful to patients. Accordingly, the Court should grant Defendants’ Motion to Dismiss.

View the entire amicus brief below.