Bribe to Prescribe—the Omnicare Debacle Continues

Mariner Health Care of Oxnard, California is the latest entity to get caught in the Omnicare Pharmacy kickback scandal that I wrote about in Could Carrots be at the Root of Psychotropic Trends back in January. The Justice Department alleged in the most recent case that both SavaSenior Care and Mariner conspired to direct nursing home business to Omnicare for 15 years in exchange for $50 million.

According the US Attorney’s Office District of Massachusetts, Mariner has entered into a Corporate Integrity Agreement with the OIG and agreed to pay a $14 million settlement to the US government. The CIA centers around ensuring that the company does not enter into arrangements that violate the antikickback statute. In addition, the Office of the Inspector General reserves its right to seek exclusion of Sava and all principals involved from participation in Medicare and Medicaid programs in the future.

Last time I wrote about Omnicare I focused on the possible relationship between pharmacy kickbacks for certain psychotropic drugs and the frequency of use of those drugs in nursing homes. I did that because I thought the antikickback statute was well known. Since this scenario continued to unfold, however, I thought I’d clarify the statute itself for my readers.

The antikickback statute is part of the Medicare and Medicaid Patient Protection Act of 1987 (42 U.S.C. 1320a-7b) and, in brief, states that anyone who knowingly and willfully solicits or receives any remuneration in return for referrals or purchase or in return for purchasing or recommending any service or item, and anyone who willfully and knowingly offers and pays any remuneration to induce referrals or purchase of any item paid for under the Medicare or a State health program shall be guilty of a felony. The statute prohibits solicitation, offering, and receiving any type of remuneration (in cash or in kind, directly or indirectly) for the defined activities.

There can be no health care driven by anything other than the true needs of residents in long-term care. This is why most long-term care organizations have rules against staff taking tips, because throwing money into the mix of resident care decisions muddies the water and makes it more difficult to be clear and clean in our judgments about who should receive what. I don’t know whether the kickbacks alleged in the Mariner and SavaSenior Care cases resulted in any wrongdoing by the companies or their facilities, but perhaps that’s the point—we can’t know for sure. As the US Attorney in this case wrote, “Nursing home residents and their families are entitled to have decisions about who provides care to them free of the distortions caused by illegal kickback schemes.”

The very existence of kickbacks gives cause for suspicion about how health care decisions are made, and that is enough to warrant action on the part of society to ensure that kickbacks do not occur at all in any form. You would certainly hate to be vulnerable, sick, and lying in a hospital bed having to wonder whether the medications being prescribed to you are the ones that would be best for your needs or the ones the pharmacy is bribing the hospital to prescribe.

Could Carrots be at the Root of Psychotropic Trends?

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.