Skip navigational links
  • Get Involved

    Learn, Network, and Connect

    Make the most of your AHLA membership! Enroll in a Practice Group, start a conversation on a Discussion List, share your expertise as a mentor, team up with a colleague to speak at a program or write an article, and much more.

    Getting involved makes AHLA a better organization, and creates professional opportunities for you.


    Join a Practice Group

    Through membership in AHLA and participation in a Practice Group, you have access to a network of leading attorneys, executives, consultants, and other advisors who are recognized deal-makers and shakers in health care. The connections made as a result of your AHLA membership will provide immediate value.

  • Find a Resource

    Your Source For Relevant Information

    More than ever, we rely on quick and easy access to relevant information for successful practice management. AHLA understands this particular need and offers you many key information sources and services that will help you be effective counsel for your clients.

    AHLA Dispute Resolution Service

    - Arbitration
    - Mediation
    - Peer Review
    - Training and Education
    - Become a Neutral

    Learn more about DRS

  • Get in Touch

    Reach out to AHLA and our health law content experts

    Get in touch with AHLA staff and leaders to find membership support, answers to your questions about programs and webinars, and press/media inquiries. Find your fellow AHLA members with the Member Directory.

    Connect with AHLA on social media!

    Follow AHLA on Twitter or Facebook

    Join our LinkedIn Group

    Subscribe to our YouTube channel

  • Who We Are

    Learn more about AHLA members, leaders, and the organization

    AHLA is the nation's largest, nonpartisan, 501(c)(3) educational organization devoted to legal issues in the healthcare field. Get to know more about our organization, our 12,500 members and leaders, and partnership and sponsorship opportunities.

    Celebrating Diversity+Inclusion

    AHLA is a welcoming, diverse, and inclusive community of those interested in health law.

    Learn more about our Diversity activities


OIG Report Released Regarding Medicare Atypical Antipsychotic Drug Use in Nursing Homes


Email Alert

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.

© 2014 American Health Lawyers Association. All rights reserved. 1620 Eye Street NW, 6th Floor, Washington, DC 20006-4010 P. 202-833-1100 F. 202-833-1105