MAKING PSYCHOTROPIC MEDICATIONS SAFE
A Petition to Ensure Access to Effective Evidence-Based Care for
Emotional, Mental and Behavioral Health



The Honorable Kathleen Sebelius
Secretary
U.S. Department of Health & Human Services
200 Independence Avenue, SW
Washington, D.C. 20201


Dear Secretary Sebelius:

As you are aware, expenditures for mental and behavioral treatments continue to rise while the quality of patient care suffers. The vast majority of behavioral health treatments are publicly funded. In 2009, the total expenditure for mental health care, substance abuse treatment excluded, amounted to approximately 4% of health care expenditures,or about $100 billion. This increase in expenditures is directly attributed to the expanded use psychotropic medications and the shift of behavioral and mental health care to primary care settings.The result of this shift has resulted in poor health outcomes and increased health care costs.

Many patients who present with symptoms of depression are being provided expensive medications as the first line treatment for their condition when many of these drugs have not been proven more effective than a placebo and where psychotherapy should be the first line treatment.

Numerous dangerous side effects have been identified with prescribed antipsychotic medications, which are the number one selling class of prescription drugs in the United States. A recent study found that widening use of antipsychotic medications is even linked to shrinkage in the brain.

We believe modest changes to reimbursement rules for Medicare and other federally funded mental health care programs will promote better patient care while reducing overall taxpayer costs associated with ineffective medications. We propose the following for your consideration:

  1. Medicare and other federally-funded mental health programs should not reimburse for any psychotropic medication unless the patient first has been appropriately evaluated and diagnosed by a doctoral level mental health specialist and where it has been determined that behavioral intervention would not benefit the patient's condition. Appropriate diagnosis is critical when considering the most effective treatment options for the patient. Moreover, the costs associated with an inappropriate prescription can be significant. In 2007, the estimated cost associated with adverse drug events was $172 billion; additional hospitalizations add approximately $6000 to a hospital stay. The fact that patients are not receiving an appropriate evaluation and diagnoses is alarming and must change.

  1. The practice of reimbursing for off-label prescribing of prescription drugs should cease. Off-label prescribing for conditions that are not approved by the FDA is inconsistent with the manifest function of why such a system exists. A 2009 study reports that among the nearly 300,000 veterans who received a prescription for an antipsychotic medication, more than 60% had no record of a diagnosis for which the drug was approved. Off-label prescribing of drugs that have not been tested for the specific condition for which they were approved is inappropriate and may be unsafe for the patient.

  1. There should be no reimbursement for any psychotropic medications that have not been validated by an unbiased peer review. Newly introduced medications should reach a standard before being prescribed to patients. Unbiased peer review will establish the effectiveness and safety of a drug. Patients should not be prescribed medications without a determination of the true risks and potential side effects.

  1. There should be no reimbursement of any psychotropic drug that has not proven to be more effective than a placebo or an existing medication currently approved in its class. Rising healthcare costs from these unneeded and usually more expensive medications occur when these drugs are prescribed. Significant benefits to patients are rarely demonstrated from medications that are not more effective than existing drugs.

  1. Strengthen the conditions that allow reimbursements for the prescription of more than two drugs of the same class. With respect to psychotropic medications, there are no reliable studies showing that more than two drugs of the same class are beneficial to patients. To qualify for reimbursement, there must be reliable and unbiased data to support prescribing more than two medications from the same class or from a class that essentially provides the same or similar side effects.


  1. Reimbursements for psychotropic medication regimens should be time limited. Unfortunately, many patients are prescribed medications on a long-term basis with no scientific basis for this extended use. Data indicates that long-term prescription
    regimens can have harmful effects on the patient including a greater likelihood to become disabled. Patients should not be treated with a drug for a time period substantially longer than has been proven safe and effective in clinical trials.

  1. Reimbursements should not be approved for prescribed doses of medications above the upper range for which the drug has been recommended and approved. Many patients are prescribed doses significantly above the upper range for which the drug has been recommended and approved with no scientific data supporting this practice. Patients face greater health risks when a drug is prescribed in amounts great than the upper limit.

At a time of severe strain on our fiscal resources, it’s imperative we vigorously pursue solutions that both reduce costs and increase quality of care. Our mental health system is often overlooked in the health care debate yet affects millions of Americans at a substantial cost to taxpayers. We believe these common sense recommendations to reform reimbursement rules for psychotropic medications will reduce costs and improve quality of care for millions of Americans. They merit strong consideration by the Department.
You can read or download a complete report on how cuts to the mental health budget can be avoided by controlling ineffective treatments HERE


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