Long-Term Care Survey Alert

Nix Your Facility-Wide ‘No CPR’ Policy

You’ll end up in hot water with the Centers for Medicare & Medicaid Services (CMS) if you don’t fully implement your residents’ advance directives.

So says a new Survey and Certification Letter (S&C) prohibiting such facility policies. “Facilities may not institute facility-wide ‘no-CPR’ policies, and prior to the arrival of emergency medical services (EMS), must provide basic life support, including CPR, to a resident who experiences cardiac arrest in accordance with his or her advance directive,” wrote Evvie Munley, senior health policy analyst with Washington, DC-based Leading Age, in a recent analysis.

“The letter advises that CPR must also be initiated in the absence of an advance directive or a Do Not Resuscitate (DNR) order,” Munley noted. “CPR-certified staff must be available at all times.”

Link: You can access the S&C at www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-01.pdf.

Heads Up: CMS Deletes F-Tag 454

In another recent S&C, CMS clarified that surveyors should more appropriately cite nursing homes previously determined out of compliance with Physical Environment, Life Safety from Fire (F-Tag 454) under the Life Safety Code (LSC) Requirements, according to Munley.

So CMS has deleted F-Tag 454 from its Automated Survey Processing Environment (ASPEN) system. The deletion will avoid duplication and redundancy, Munley noted. F-Tag 454 is more appropriately cited under LSC requirements.

Link: You can read the entire S&C at www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-03.pdf.

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 Elder Care 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.