The intersection of Informed Consent, EMTALA, and the False Claims Act

Two recently unsealed False Claims Act cases involving violations of material federal requirements provide a glimpse into areas that physicians and providers should be evaluating for continued compliance.

“Medicare is generally required… (for services covered under Part A … [and] for services covered under Part B) to pay for services furnished by providers on the basis of reasonable costs … 42 C.F.R. § 413.1 (2014)” There are of course requirements that need to be met. For example, Medicare Conditions of Participation: Medical record services requires that a patient’s medical record include “[p]roperly executed informed consent forms for procedures and treatments specified by the medical staff, or by Federal or State law if applicable, to require written patient consent.” 42 C.F.R. § 482.24(c)(4)(v) (2012). Subsequently, the Centers for Medicare and Medicaid Services (“CMS”) interpreted this regulation in the CMS State Operations Manual, App’x A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals, A-0466, Interpretive Guidelines §482.24(c)(4)(v), p. 289 (2018) (Rev. 95, effective Jun. 7, 2013) to mean “[a]n informed consent form, in order to be properly executed, must be consistent with hospital policies as well as applicable State and Federal law or regulation.” (emphasis added).

The underlying principle of informed consent brings us to two recent False Claims Act (“FCA”) cases.

• United States ex rel. Garrett v. Kootenai Hosp. Dist., No. 2:17-cv-00314-CWD (D. Idaho June 17, 2020). The Relator alleged that six specific acts were legally fraudulent false claims, including: the defendant submitted claims to Medicare for services rendered at facilities misrepresented as “provider-based”; for services provided by non-physicians but billed under the Medicare Physician Fee Schedule; for inpatient admissions without physicians’ orders; for patients billed for co-payments in violation of the Emergency Medical Treatment and Labor Act; for claims with false diagnosis codes; and for patients whose rights Kootenai had violated. The U.S. District Court denied the defendants’ Motion to Dismiss.

• United States ex rel. Zaldonis v. University of Pittsburgh Medical Center et al., Case No. 2:19-cv-01220-MJH (W.D. Pa. Sept. 24, 2019). The allegations in this case stem from the defendants knowing failure to properly obtain informed consent from patients for surgeries, which led to the filing of false claims, which were filed with various government agencies, including CMS. The court has not yet ruled on a Motion to Dismiss.

Informed consent can only be obtained by a patient who has decision making capacity. As I indicated in a 2017 Physician’s Practice article, “[f]ederal regulations governing informed consent are known as the Common Rule and are found at 45 C.F.R. Part 46 (Subpart A).” Hence, it appears as though obtaining a patient’s informed consent is material to the federal government’s payment of claims. By way of analogy, this makes sense. For example, in 2019, Vanguard Healthcare, a nursing home chain headquartered in Tennessee, settled FCA allegations with “the United States and Tennessee … that five Vanguard nursing facilities failed to administer medications as prescribed; failed to provide standard infection control, resulting in urinary tract infections and wound infections; failed to provide wound care as ordered; failed to take prophylactic measures to prevent pressure ulcers, such as turning and repositioning; used unnecessary physical restraints on residents; and failed to meet basic nutrition and hygiene requirements of residents.” The notion of applying unnecessary restraints on residents, especially in the emergency room setting where hospitals may be tempted to restrain patients against their will in order to bill for stabilization and treatment under the Emergency Medical Treatment and Labor Act (EMTALA). Additionally, like a nursing home, an acute care hospital may choose to provide substandard care in order to not have to deal with a patient and subsequently bill the patient for additional costs associated with the substandard care or worthless services. Either way, the two FCA cases are ones to watch, while simultaneously reviewing compliance with informed consent and other federal and state standards.

_{About the Author}

_{Rachel V. Rose, JD, MBA, advises clients on compliance and transactions in healthcare, cybersecurity, corporate and securities law, while representing plaintiffs in False Claims Act and Dodd-Frank whistleblower cases. She also teaches bioethics at Baylor College of Medicine in Houston. Rachel can be reached through her website, www.rvrose.com.}