The role of government, at a minimum, is to protect those who cannot protect themselves.  While there is no more vulnerable a population than nursing home residents,  the sad truth is that health care providers entrusted to deliver appropriate care have instead caused unspeakable harm to some of the frailest members of our society. Additionally, the regulatory system has for far too long tolerated the provision of inadequate care by allowing cyclical non-compliant providers to continue receiving federal funds while providing grossly substandard care.  This article is intended to identify what constitutes neglect in the nursing home arena and legal theories used by federal prosecutors to address this important issue.

         Neglect has been defined in federal regulations to mean the failure to provide goods or services necessary to avoid physical harm, mental anguish, or mental illness.  42 Code of Federal Regulations Section 488.301.  This definition does not set forth any intent standard by a perpetrator of neglect, rather it focuses on the failure to act as the key to analyzing whether neglect has occurred.  Providers have long expressed concern that this language would be broadly interpreted by prosecutors and as a result, unwarranted investigations and prosecutions would be brought.  Simply stated, that has not been the case.  However, it is instructive to analyze what federal prosecutors are looking for when evaluating possible neglect violations and the theories that would be pursued in that regard.

        Failure of care cases emanate from a pattern of neglectful conduct by long-term care facilities that has caused harm to residents.  Evidence of virtually no clinical response by providers to such medical conditions as profound malnutrition, dehydration, and pressure sore development have formed the basis for evaluating whether a case merited investigation and settlement.  The government has settled cases based on a provider’s lack of proper care to diabetic residents or the failure to respond to residents at risk for falls who then fall and suffer serious bodily harm.  From a prosecutor’s perspective, some of the most difficult assessments revolve around what constitutes neglect?  A case example may be instructive:

      Several residents need assistance with feeding. The nursing home knows this to be the case and makes it clear on the residents’ chart and other relevant documentation.  Food is delivered to the residents’ room or provided in the dining area.  However, the nursing home is understaffed and the residents do not receive assistance on numerous occasions and over time and as a result, suffer unintended weight loss and other serious complications resulting from this failure to provide nutrition.

      In this example, while regulators may cite the facility for various deficiencies relating to quality of care, the overall conduct of the facility constituted neglect.  The focus of any investigation will be on why this conduct was allowed to occur, what actions were taken by the facility, and the nature of the harm to the residents.  This harm may include not only weight loss but other issues such as malnutrition, pressure sore development, and other possible complications.  Harm to the residents will be a motivating factor in any investigation by law enforcement personnel.

 Legal Theories

        There is no federal patient abuse and neglect statute so government attorneys have effectively used a financial fraud statute, the federal False Claims Act, to address failure of care cases throughout the country.  There has been much debate regarding the use of the federal False Claims Act in pursuing failure of care cases in the nursing home and hospital settings. The statute prohibits the knowing submission or causing the submission of false claims to the government for payment.  31 U.S.C. Section 3729.  In addition, the statute prohibits the making or using a false record or statement in support of claims submitted to the government.  31 U.S.C. Section 3729 (a)(2).  Each false claim submitted is subject to treble damages plus a penalty of between $5500 and $11,000.  Obviously, there is the potential for significant recoupment of funds by the government even based on a relatively small amount of fraud.  The goal of course was to make fraud against the government so undesirable that it would deter potential wrong-doers.

         It is critical that health care providers recognize the implications of the provision addressing the use of a false record in support of claims.  For example, a provider submits a plan of correction (POC) to the state regulatory agency, acting as contract agents for the Centers for Medicare and Medicaid Services (CMS), in which it certifies that it will address the deficiencies for which it was cited.  The POC certifies to the government that the provider will act in a certain fashion and, more importantly, continues the provider’s participation in the Medicare Program and the payments flowing.  The provider then knowingly fails to implement the POC. This knowing failure to comply with the POC will subject the provider to False Claims Act liability.

         The falsification of records will also subject providers to not only civil liability, but potential criminal liability as well.  Federal criminal law prohibits the knowing and willful making or using of any materially false writing or document, or fraudulent entry, in the connection with the delivery of health care services.  18 U.S.C. Section 1035.  This crime has been used to prosecute individuals who have falsified patient charts to cover-up medication errors and care that was not, in fact, rendered. 

     Worthless Services

         Failure of care cases based on neglectful conduct may be based upon a “worthless services” theory.  The example in the beginning of this article supports a worthless services argument.  Though food was cooked and delivered to a resident’s room, the fact that the resident could not eat without assistance and the provider failed to provide this assistance, made this a worthless service.  The notion that a provider would obtain payment for services that were tantamount to no care at all is unacceptable and actionable as a fraud on the government.

 False Certification

        Next, the government has also used what is known as the false certification theory.  This theory imposes liability based on a false certification of compliance with the law governing the provision of care to nursing home residents.  An “express certification” exists when a claim is submitted that contains a false certification as to compliance with the law.  However, when a provider submits a claim to the government for care that allegedly was substandard, the government often asserts that the provider submitted a false claim because the claim includes an “implied "certification of compliance with all Medicare and Medicaid statutes and regulations, including those governing quality of care and compliance with that standard was a pre-requisite to payment. 

         There has been much litigation in this area and a few courts have held that compliance with the regulatory requirements must be a condition of payment or there is no false claim.  In response, the government’s theory is that courts should not focus on whether the applicable statute or regulation explicitly conditions payment on compliance with the particular requirement.  Rather, courts should review the language of the requirements, Congressional and regulatory intent to determine whether failing to comply with the requirement renders an entity or person ineligible for payment, and whether evidence supports the conclusion that defendant knowingly submitted a false claim.  The government maintains that as long as there is a nexus to payment, the False Claims Act can be implicated.  Some courts have adopted this position when addressing failure of care claims.

 The Future

         As a society we cannot and should not tolerate the neglect of our nursing home residents.  Providers must implement meaningful quality assurance and improvement programs that include training and competency evaluations of their staff at all levels to ensure resident safety.  At the same time, there must be vigilant oversight by state and federal regulators and prosecutors to address those providers who violate the law.  To do any less is simply unconscionable.