On Friday, the US Department of Justice filed a civil False Claims Act complaint against Johnson & Johnson and two of its subsidiaries. It claims that the companies paid millions of dollars in kickbacks to Omnicare, Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home residents. In November 2009, Omnicare entered into a $98 million dollar settlement agreement that resolved its civil liability under the False Claims Act for taking kickbacks from J&J.
The government alleges that J&J viewed Omnicare pharmacists as an extension of its sales force because Omnicare pharmacists reviewed nursing home patients’ charts, and subsequently recommended to the patients’ physicians which drugs should be prescribed for each patient. It also contends that these physicians accepted Omnicare pharmacists’ recommendations more than 80 percent of the time. In addition, the government asserts that J&J paid several forms of kickbacks to Omnicare, including rebates for the pharmacy’s implementation of programs designed to increase J&J prescriptions; paying for “data” never provided; and providing substantial “grants” and “educational funding” as inducements to recommend J&J drugs.
This weekend as I read the government’s complaint, I was especially troubled to see that listed among the drugs eligible for J&J kickbacks to Omnicare for use in nursing homes was its antipsychotic drug, Risperdal.
In recent years, I have seen a growing tendency of physicians to prescribe psychotropic medications to nursing home residents, with or without a psychiatric diagnosis.
If these allegations are true, I’m left to ponder the extent to which Big Pharma carrots contribute to healthcare providers’ selection of drug interventions without first attempting non-pharmacological interventions.
And while I'm on the topic of patient assessments prior to psychopharmaceuticals are prescribed...
I have noticed that PASRR (Pre-admission Screening and Annual Resident Review) assessments sometimes don’t match the drug regimen. Not uncommonly, a PASRR on admission to the facility will note no mental illness or disability and yet routine anti-psychotic or antidepressant medications are ordered.
In a study of the use of the PASRR to assess serious mental illness in nursing home residents, PASRRs from 44 states and 24 nursing homes were studied by reviewing medical records. The authors of the study concluded that, “Nursing facility compliance with administration and documentation of PASRR screens appears problematic. Nevertheless, there do not appear to be excessively high numbers of residents with serious mental illness, suggesting that state PASRR programs may contribute positively to the identification of people with serious mental illness. Many nursing facility residents, however, have some type of psychiatric illness, and PASRR legislation does not appear to have enhanced their ability to gain access to mental health services beyond standard psychiatric consultation and medication therapy.”
If there are not excessively high numbers of residents with serious mental illness, why does there seem to be so many on psychotropic medications?
Are we observing behaviors then seeking diagnoses to justify the use of drugs? If so, this is problematic for both quality of care and quality of life.
A more life-affirming approach is to observe behaviors, drill down to the root cause of the behavior—what exactly is triggering or causing it—and then address the root cause with non-drug interventions on a case-by-case basis. When it has been proven that all else fails, a medication may be appropriate.
Of course, medications are required for some mental health diagnoses. Even still, many medications such as antidepressants were never designed to be used indefinitely. Instead, they were developed to allow the individual to regain enough reserve to deal with the problems they face and once they improve, the drug can be slowly withdrawn.
In addition to searching out root causes of behavioral symptoms on a case-by-case basis, we encourage our client facilities to have their Behavior Management Committees track and trend behavioral triggers facility-wide. In this way, root causes that are common in the facility can be addressed more globally as the interdisciplinary team can design facility-wide interventions that solve problems for many residents at the same time. This process also allows facilities to identify areas for performance improvement such as staffing shortages at certain times or staff skills competencies that need development before they become bigger regulatory or compliance problems. This is how facilities are getting ahead of the behavior management challenges they increasingly face in today’s environment.
So, what should long-term care do with news like the allegations against Omnicare and J&J?
Clearly it can’t monitor all the marketing programs of drug manufacturers; and correlate them to the drug recommendation proclivities of pharmacists and the prescription-writing trends of physicians. It would be beneficial, however, to implement the kind of quality and performance improvement measures I have discussed so that facilities can rely less on their pharmacy consultants and more on the critical analysis of their interdisciplinary teams, armed with excellent data about root causes and trends. This process would improve quality indicators throughout the industry.
Most of all, we as an industry need to put quality of life as the top priority and stop turning to drug interventions as the first line of defense for problem behaviors. Where psychotropic drugs are concerned, doing so would have thwarted Omnicare and J&J at the door.
Monday, January 18, 2010
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Beata Chapman, Ph.D., CHC
President
Long Term Health Care and Compliance