May 16, 2011
By Janet Feldkamp*
The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently released a report discussing the atypical antipsychotic drug claims for nursing home residents who are ages sixty-five or older. The report was initiated at the request of Senator Charles Grassley (R-IA) regarding the atypical use of the antipsychotics and the associated cost to the Medicare program. An analysis of a sampling of Medicare Part D and Part B claims from 2007 for selected elderly nursing home residents for atypical antipsychotic drugs was utilized as the basis of the study.
Eight atypical antipsychotic drugs have been approved by the U.S. Food and Drug Administration (FDA) for the use in treating psychiatric illnesses including schizophrenia and/or bipolar disorder. Physicians may prescribe an FDA-approved drug for other uses than approved diagnoses and this prescribing practice is known as "off-label use." Off-label use of atypical antipsychotic medications carries a number of significant potential dangers, particularly for the elderly. In 2005, FDA required manufacturers of these atypical antipsychotic medications to include a boxed warning on the products' label to warn prescribers and consumers of the significant potential adverse side effects. Despite the "black box" warning language, medications are continuing to be prescribed for off-label, use and this OIG study determined that this type of use was fairly frequent for the elderly nursing home residents.
Study findings included:
14% of the elderly nursing home residents had Medicare claims for atypical antipsychotic drugs;
83% of the Medicare claims for atypical antipsychotic drugs for elderly nursing home residents were for off-label uses, and 88% of those were associated directly with the conditions specified in the black box warning;
51% of the Medicare atypical antipsychotic drugs claims were "erroneous," amounting to $116 million in cost to the Medicare program; and
22% of the atypical antipsychotic drugs claims were not administered within the regulatory requirements for Medicare/Medicaid participation for the nursing homes regarding the prevention of unnecessary drugs requirement.
OIG provided four specific recommendations to the Centers for Medicare & Medicaid Services (CMS). These recommendations included working to facilitate access to information to ensure accurate coverage and reimbursement determinations, assessing if the survey and certification processes offers adequate safeguards to prevent unnecessary antipsychotic drugs use in nursing homes, exploring methods in addition to the survey and certification process to promote compliance with elimination of unnecessary drugs in nursing homes, and taking appropriate action regarding claims associated with erroneous payments to pharmacies identified in the study. CMS has responded with a discussion of the recommendations and its potential actions.
Healthcare attorneys should be discussing with their nursing home clients the potential for increased scrutiny in the medication monitoring and unnecessary drug aspects of the survey process. It should not be surprising if there is a spike in citations related to unnecessary medications, particularly with the atypical antipsychotic drugs and any off-label use following the issuance of this report.
*We would like to thank Janet K. Feldkamp RN, BSN, LNHA, JD (Benesch Friedlander Coplan & Aronoff LLP, Columbus, OH), for authoring this email alert.