MDS Alert

Published on Mon Nov 18, 2013 PDF

Also, here’s another RAI manual Appendix B update.

Therapy animals help to ease aggression and depression in nursing home residents suffering from dementia, according to a new study published in the American Journal of Geriatric Psychiatry.

The researchers studied 65 nursing home residents with dementia who were assigned Animal-Assisted Therapy (AAT) as part of their treatment(s) over the course of 10 weekly sessions. Using the Cohen-Mansfield Agitation Inventory and the Dementia Mood Assessment Scale, the researchers determined a baseline of aggression and depression symptoms among the participating residents.

When the researchers compared that baseline to subsequent tests performed at the end of the 10-week period, they discovered that the residents who received the AAT had steady, unchanged frequency and severity of aggression and depression symptoms. The control group not receiving AAT, however, experienced significantly increased agitation/aggression and depression.

“AAT is a promising option for the treatment of agitation/aggression and depression in patients with dementia,” the study states. “Our results suggest that AAT may delay progression of neuropsychiatric symptoms in demented nursing home residents.” But the researchers concede that more research is necessary to determine the long-term effects of AAT on dementia.

In other news …

Get Ready for More Appendix B Changes

On Oct. 22, the Centers for Medicare & Medicaid Services (CMS) released yet another update of the Resident Assessment Instrument (RAI) manual’s Appendix B. The updated Appendix B contains changes to the lists of MDS automation coordinators, state RAI coordinators, RAI panel members, and regional office contacts.

To view the updated Appendix B, go to www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/MDS30RAIManual.html and scroll down to the Downloads section at the bottom of the page.

Was Your Nursing Home Duped by the Risperdal Scheme?

If a sales representative bent your ear on the wonders of Risperdal in treating dementia symptoms, that sales rep wasn’t telling the whole truth about the drug.

Janssen, a subsidiary of pharmaceutical giant Johnson & Johnson (J&J), pled guilty to misbranding its antipsychotic drug Risperdal, according to a Nov.4 U.S. Department of Justice (DOJ) announcement. Although the U.S. Food & Drug Administration (FDA) had approved the drug only to treat schizophrenia, Janssen’s sales reps allegedly promoted the drug to prescribers for treating elderly dementia patients.

Specifically, the company’s ElderCare sales reps touted Risperdal as a drug to treat dementia symptoms like anxiety, depression, agitation, confusion, and hostility, the DOJ alleges. Janssen purportedly created and used written sales aids that emphasized Risperdal’s use in treating these symptoms but down-played any mention of the drug’s FDA-approved use for treating schizophrenia.

“In a plea agreement resolving these charges, Janssen admitted that it promoted Risperdal to health care providers for treatment of psychotic symptoms and associated behavioral disturbances exhibited by elderly, non-schizophrenic dementia patients,” the DOJ states. Under the plea agreement, Janssen must pay a criminal fine of $334 million and a forfeiture of $66 million.

The plea agreement comes along with other penalties involving J&J and its subsidiaries for also promoting uses of the drugs Invega and Natrecor for uses not approved by the FDA. The criminal and civil investigations allege that J&J also paid kickbacks to long-term care pharmacies and physicians. Altogether, J&J will pay out more than $2.2 billion to resolve the allegations relating to Risperdal, Invega, and Natrecor, according to the DOJ.

Link: For more information, read the DOJ’s complete announcement at www.justice.gov/opa/pr/2013/November/13-ag-1170.html.