Risks of Over-Medicating Residents and Potential Liability Under the FCA

On August 24, 2014, the United States Federal government filed an action under the False Claims Act (FCA) against two California nursing homes and their corporate parents for allegedly overmedicating residents.

According to the Complaint, Country Villa Watsonville East Nursing Center (now Watsonville Nursing Center) and Country Villa Watsonville West Nursing and Rehabilitation Center (now Watsonville Post-Acute Center) “persistently and severely overmedicated elderly and vulnerable residents of the Facilities” between 2007 and 2012. These “victims of chemical restraints” were allegedly overmedicated “for the convenience of management.” The Complaint asserts that the overmedication amounts to “non-existent, grossly inadequate, materially substandard and/or worthless services to Medicare and Medicaid beneficiaries in violation of Medicare and Medicaid requirements.” In addition to treble damages, the government requests additional penalties of $5,000 to $11,000 for each violation. For a copy of the Complaint, click here.

In support of its claims under the FCA for overmedicating residents, the government relies upon the Centers for Medicare and Medicaid Services (CMS) regulation requiring that each resident’s drug regimen be free from unnecessary drugs. 42 CFR 483.25(1)(1). Per this regulation, which is a condition of participation but not a condition of payment, an unnecessary drug is any drug when used: (i) in excessive dose (including duplicate drug therapy); (ii) for excessive duration; (iii) without adequate monitoring; (iv) without adequate indications for its use; (v) in the presence of adverse consequences which indicate the dose should be reduced or discontinued; or (vi) any combinations of these reasons.

Further, as to antipsychotic drugs, the regulations provide that the facility must complete a comprehensive assessment of a resident and ensure that:

1. Residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and
2. Residents who use antipsychotic drugs receive gradual dose reductions and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.

42 CFR 483.25(1)(2).

As examples of fraudulent or false claims, the government cites to residents who were given antipsychotic and psychotropic drugs which allegedly resulted in “infection, sepsis, malnutrition, dehydration, falls, fractures, pressure ulcers, and for some residents, premature death.” For instance, the government alleges that one of the nursing homes administered antipsychotics Haldol and Risperdal to an eighty-six year old resident resulting in sedation to the point of near immobility, development of pressure ulcers and significant functional decline.

Overmedication of patients is an issue that CMS and leading healthcare organizations have been attempting to address over the past several years. In 2012, CMS launched the "National Partnership to Improve Dementia Care and Reduce Unnecessary Antipsychotic Drug Use in Nursing Homes." As recently announced, the National Partnership met its initial goal of reducing the use of antipsychotic medication in long term care residents by 15 percent. A new goal has been announced- a 25 percent reduction by the end of 2015 and a 30 percent reduction by the end of 2016.

As the issue of overmedication becomes an area of increased focus, the government may more aggressively pursue worthless service FCA claims on this basis. Providers should understand the potential consequences that antipsychotic and psychotropic medications may have on residents and should establish policies to ensure such medications are being used as minimally as possible and regulations are being followed. To assist in this undertaking, providers should consider the following initiatives:

• Develop and implement a policy along with the facility’s medical director and pharmacist aimed at decreasing the use of antipsychotic medications among residents.
• Along with attending physicians, ensure that underlying causes of behavior have been identified and addressed prior to the use of antipsychotic medications and that medications are being prescribed at the lowest levels for the shortest amount of time possible. Ensure that there is proper documentation identifying these factors.
• Consider forming an interdisciplinary team to review residents taking antipsychotic medications, including  dementia residents.
• Review these residents in the facility's audit process to ensure compliance with the revised survey guidelines.

With a comprehensive, multi-disciplinary team effort focused on reducing the use of antipsychotic drugs for long term care residents, providers will not only improve care to residents but also anticipate and guard against the imminent increased scrutiny by the government of the use of these medications.