On December 15, 2021, the United States Court of Appeals for the Fifth Circuit issued a ruling which modifies an earlier court national injunction related to the CMS mandatory vaccination rules. In the latest ruling, the court upheld the injunction issued by the United States District Court for the Eastern District of Missouri as it applied to the fourteen (14) plaintiff states, Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Indiana, Mississippi, Oklahoma, South Carolina, Utah, West Virginia, Kentucky, and Ohio. However, it overturned the lower court’s expansion of that injunction to other, non-plaintiff states, in the injunction. Meaning that between the 5th and 8th Circuit Court rulings, the CMS mandatory vaccination injunction only applies to the following 24 states:
5th Circuit Plaintiffs: Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Indiana, Mississippi, Oklahoma, South Carolina, Utah, West Virginia, Kentucky, Ohio
8th Circuit Plaintiffs: Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota and New Hampshire.
States not covered by the CMS mandatory vaccination injunction:
California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont, Virginia, Washington, and Wisconsin
This decision, follows another mandatory vaccine related decision issued by the United States Court of Appeals for the Eleventh Circuit which criticized the Louisiana court for expanding the CMS vaccine mandate nationwide given that a Florida District Court had already refused to issue an injunction and because it felt that it was likely that the mandate was likely authorized under current CMS rules.
What does this mean for employers?
If you are an employer in one of the states not covered by an injunction, you should consult with any covered healthcare facility that your organization performs services under contract. These covered healthcare facilities will be required to mandate vaccination for their staff and for any contractor staff that interacts with their employees or patients. Additionally, they will be seeking proof that your staff is vaccinated against COVID-19, unless they have a protected medical or religious accommodation.
Employers should have already taken the initial steps toward compliance with the CMS mandatory vaccination rules, including having a list of all employees with their vaccination status. Additionally, employers should have an established policy related to mandatory vaccination and a procedure for requesting and processing an exception/accommodation requests. Lastly, healthcare institutions may independently institute mandatory vaccination rules for their employees and can require this of anyone entering their facility, including EMS staff.
We will continue to keep you post as these cases proceed through the legal system. These facilities may still independently require your staff to be vaccinated. If your organization has questions or need assistance deciphering or preparing for these requirements, please contact the AAA by emailing email@example.com.
On Monday, November 29, 2021, the United States District Court for the Eastern District of Missouri – Eastern Division has issued a preliminary injunction staying the Centers for Medicare and Medicaid Services (CMS) Mandatory Vaccination Emergency Temporary Standards (ETS) which were set to take effect on January 4, 2022. This preliminary injunction currently only applies to healthcare providers in the plaintiff states.
On November 10, 2021, the States of Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, and New Hampshire filed a nine (9) count complaint in the United States Court for the Eastern District of Missouri seeking relief from the CMS Emergency Temporary Standard (ETS) which requires certain certified healthcare facilities to mandate COVID-19 vaccination of all employees, contractors, and those performing services “under arrangement.” The complaint alleged that the ETS violates numerous provisions of the Administrative Procedures Act (APA), the Social Security Act (SSA), that CMS failed to consult with the state agencies that would be charged with enforcing such a mandate, failure to perform an impact analysis of the new rules, and several other Constitutional violations.
In the ruling, U.S. District Judge Matthew T. Schelp, agreed with the plaintiffs that a preliminary injunction was warranted because it posed an irreparable harm and that the plaintiffs demonstrated a likelihood of success on the merits of their complaint. The thirty-two (32) page ruling cites that Congress did not give CMS the authority to enact the mandatory vaccination regulations, nor authorized CMS to issue regulations that pre-empt validly enacted state legislation that contradict these new rules. The court believed that the plaintiffs would likely be able to show that CMS violated numerous administrative and rulemaking procedures.
Throughout the ruling the court cited the likelihood of significant harm to state sovereignty and how the implementation of the rule’s requirements would cause substantial economic harm to both the states and the healthcare facilities. Not only through the cost of implementation but also through the impact to a healthcare facility’s ability to provide care due to employees who refuse to get vaccinated.
This ruling is only applicable to covered healthcare facilities in the states of Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, and New Hampshire. It is unknown if the stay will be expanded to other jurisdictions. Additionally, the OSHA Vaccination & Testing ETS is currently enjoined and OHSA has announced that they will halt implementation and enforcement associated with those rules. Despite these rulings, many EMS employers are subject to the mandatory vaccination requirements under the Safer Federal Workforce Task Force COVID-19 Workplace Safety: Guidance for Federal Contractors and Subcontractors.
I advise employers to take the initial steps toward compliance while these cases proceed through the legal system. EMS employers are already required to have policies and procedures to determine and maintain a log of their employee’s vaccination status. Additionally, many EMS employers have already been contacted by their contracted healthcare facilities who have enacted a vaccine mandate, either prior to, or in response to the CMS ETS. These facilities may still independently require your staff to be vaccinated.
I recognize that these are incredibly challenging times. If your organization has questions or need assistance deciphering or preparing for these requirements, please contact the AAA by emailing firstname.lastname@example.org.
Supreme Court issues a decision clarifying under Implied False Certification Theory
On June 16, 2016, the Supreme Court issued a decision that clarifies the liability of federal contractors, including health care providers that participate in the Medicare or Medicaid programs, under the False Claims Act for implied frauds. Writing for a unanimous court, Justice Clarence Thomas held in Universal Services v. United States ex rel. Escobar that the so-called “implied false certification theory” can serve as the basis for False Claims Act liability in situations where a federal contractor has submitted claims for payment, and where the contractor makes specific representations regarding the services it has provided but fails to disclose the contractor’s non-compliance with one or more material requirements that make those representations otherwise misleading. The Court further held that liability under the False Claims Act does not turn on whether the noncompliance related to a requirement that had been expressly designated as a condition for payment.
The case involved Universal Health Services, Inc., and its subsidiary Arbour Counseling Services. Arbour operated a mental health facility in Lawrence, Massachusetts. For the period from 2004 through 2009, Arbour provided mental health counseling services to Yarushka Rivera, a Massachusetts Medicaid beneficiary. In May 2009, Rivera had an adverse reaction to a medication that a purported doctor at Arbour had prescribed after diagnosing her as suffering from bipolar disorder. In October 2009, Rivera had a seizure and died. At the time of her death, she was 17 years old.
Following Rivera’s death, a counselor employed by Arbour indicated to Rivera’s mother and stepfather that only a handful of Arbour employees were actually licensed mental health professionals. Further investigation revealed that only 1 of the 5 professionals that had treated Rivera was properly licensed. The practitioner that diagnosed Rivera as bipolar had identified herself as a Ph.D; however, it turns out that her degree was from an unaccredited Internet college, and that the State of Massachusetts had rejected her application to be licensed as a psychologist. The individual that prescribed the medication that ultimately led to Rivera’s death held herself out to be a psychiatrist, when in fact she was a nurse who lacked the authority to prescribe medications. 21 other Arbour employees were found to have lacked the proper licensures to provide counseling services.
In 2011, the mother and stepfather filed a qui tam alleging that Universal Health had violated the False Claims Act under an implied false certification theory of liability. Specifically, they alleged that Universal Health had made representations that its services were provided by specific types of professionals, but failed to disclose the numerous violations of the Massachusetts Medicaid Program’s regulations pertaining to staff qualifications and licensing.
The federal district court granted Universal Health’s motion to dismiss the complaint. While local precedent had previously embraced the implied false certification theory of liability, the district court held that liability could not be established because none of the regulations Arbour was alleged to have violated constituted a condition of payment. The First Circuit Court of Appeals reversed the lower court.
The Supreme Court agreed to hear the case to resolve the disagreement among the Circuit Courts over the validity of the implied false certification theory of liability. In his decision, Justice Thomas noted that the Seventh Circuit had expressly rejected the theory. Other Circuit Courts had accepted the theory, but limited its application to cases where the defendant failed to disclose violations of expressly designated conditions of payment. Finally, some Circuit Courts had held that the condition of payment need not be expressly designated as such to establish False Claims Act Liability.
The Court first held, in no uncertain terms, that the implied false certification theory can, under certain circumstances, provide a basis for liability under the False Claims Act. The Court emphasized that common-law fraud has long encompassed certain misrepresentations by omission. To establish False Claims Act liability, the Court determined that two conditions must be satisfied: (1) the claim must not merely request payment, but must also make specific representations about the goods or services provided and (2) the parties’ failure to disclose its noncompliance with material statutory, regulatory, or contractual requirements must render those representations misleading.
The Court then turned to Universal Health’s contention that, even if one accepts the implied certification theory, its application must be limited to misrepresentations about express conditions of payment. Justice Thomas rejected this interpretation, noting that nothing in the statute suggested that an express condition of payment was relevant to determining whether a claim was false or fraudulent. However, the Court failed to adopt the expansive ruling offered by the federal government, namely that any omission made in connection with a request for payment could trigger False Claims Act liability. Instead, the Court adopted a relatively narrow view of those omissions that could establish liability, focusing primarily on the concept of “materiality.” Essentially, the Court held that the omission would only trigger liability if its proper disclosure was outcome determinative. In other words, the omission would be considered material if its proper disclosure would have likely resulted in the claim being denied.
A number of commentators have suggested that the Court’s ruling expands the scope of potential False Claims Act liability. This is undoubtedly true for contractors (including health care providers) that operate within the Seventh Circuit’s jurisdiction (Illinois, Indiana, and Wisconsin), which previously rejected the implied false certification theory. However, the impact of the Court’s ruling on other parts of the country will be more nuanced. In some important respects, the creation of the new materiality requirement may limit the instances in which the government can establish False Claims Act Liability.
To see how this decision could be applied to the EMS industry, consider the following hypotheticals:
The first hypothetical is a close parallel to the facts of the actual case before the Court. Applying the Court’s reasoning, False Claims Act liability would hinge on whether the omission of the fact that the EMT’s certification had lapsed was material. In other words, if the court feels that the State Medicaid Program would have likely rejected the claim had the lapse in certification been properly disclosed, then liability under the False Claims Act liability might exist. If, however, the State was likely to have treated the lapse as a minor technical violation but not something worthy of denying the claim, then False Claims Act liability would not exist. Note: in the actual case, the State of Massachusetts investigated Arbour’s misconduct, and decided the appropriate action was a nominal fine, and not the recoupment of its Medicaid payments.
The second hypothetical is a bit more complex. There is no question that the failure to disclose that the lifetime signature had been revoked was an omission. It could also be argued that its omission was misleading, i.e., by not disclosing that the lifetime signature had been revoked, the provider was suggesting that it had the patient’s affirmative consent to the submission of the claim, when in fact it did not. The question is whether the omission was material to Medicare’s decision to pay the claim. On the one hand, the Medicare regulations do make compliance with the patient signature requirement an express condition for payment. One the other hand, Medicare permits that requirement to be satisfied in multiple ways, several of which do not require the patient’s affirmative consent. In the hypothetical, the patient had a legal guardian, which strongly suggests that he or she would have been incapable of signing at the time of transport anyway. Wat if the ambulance provider subsequently obtained a valid form of secondary verification? What if the ambulance provider subsequently obtained verbal consent from the legal guardian to the submission of the claim? Would Medicare be likely to deny the claim on the basis of not complying with the strict documentation standards of the signature requirement, even though the patient (through his or her guardian) has no objection to the submission of the claim?
Only time will tell how future courts interpret this material standard. Stay tuned.