Late last year, the New York State Medicaid Drug Utilization Review Board (DURB) recommended new protocols in connection with the prescribing of benzodiazepines under the Medicaid program. Benzodiazepines, a controlled substance, are a class of psychotropic medication used to reduce symptoms of anxiety as part of the treatment of many mental illnesses. This class of psychoactive medications includes, for example, Valium®, Ativan®, and Xanax®. The new protocols went into effect on March 20, 2014 and include, among others, a requirement for anti-depressant step therapy prior to initiation of benzodiazepines in the treatment of generalized anxiety disorder and social anxiety disorder and a requirement for anti-depressant therapy concurrent with benzodiazepines in the treatment of panic disorder.
The New York State Psychiatric Association (NYSPA), the state medical specialty association of psychiatrists, is concerned that these new restrictions on benzodiazepine therapy do not reflect generally accepted psychiatric practice, may disparately impact access to necessary psychiatric care and treatment for Medicaid beneficiaries, and will significantly increase the burden on psychiatrists and other physicians choosing to prescribe these medications.
For example, one of the new protocols requires that a benzodiazepine used in the treatment of panic disorder be prescribed concurrently with an antidepressant, unless the prescriber contacts the Medicaid managed care plan and successfully advocates for coverage of the benzodiazepine on its own. Mandatory concurrent use of an anti-depressant along with a benzodiazepine is not supported by well-established guidelines for the treatment of panic disorder. The American Psychiatric Association Practice Guidelines for the Treatment of Panic Disorders (the “Practice Guidelines”) do not advocate for concurrent or step therapies in connection with benzodiazepines because benzodiazepines provide an effective opportunity for rapid symptom reduction. Even though certain anti-depressants are considered effective therapies for the treatment of panic disorder, they are not appropriate or indicated in all cases for a variety of reasons.
Another protocol creates a new step therapy requirement in connection with an initial benzodiazepine prescription for generalized anxiety disorder (GAD) or social anxiety disorder. In this case, the initial benzodiazepine prescription will not be approved absent a previous antidepressant trial, unless the prescriber intervenes and successfully demonstrates that the step therapy would not be clinically recommended. In fact, this new protocol directly conflicts with generally accepted psychiatric practice, which provides for the use of a benzodiazepine for short term relief with the possible subsequent introduction of an anti-depressant for long term symptom reduction. Under no circumstances would a psychiatrist treating a patient with acute GAD or social anxiety symptoms prescribe a trial of anti-depressants to be followed up with a benzodiazepine. In fact, this approach represents the direct opposite of generally accepted treatment protocols for patients with acute GAD and social anxiety disorder.
Under both the step therapy and concurrent therapy recommendations, if prescriber intervention and advocacy is not successful, providers would be required to either take patients off their current benzodiazepine in order to “try” an anti-depressant or add an anti-depressant to current medication regimes even if the patient is clinically stable. However, if a patient is doing well on a benzodiazepine and is showing no evidence of tolerance or dependence, there is no clinical reason to take them off their medication. Many individuals experience withdrawal symptoms in connection with tapering of benzodiazepines and to subject them to these possible symptoms in favor of an unwarranted anti-depressant trial seems clinically inappropriate. Further, all anti-depressants are not effective for all individuals and many have undesirable side effects. As noted in the Practice Guidelines, benzodiazepines represent an excellent treatment option for individuals with severe symptoms that need to be controlled rapidly and should not be compromised by step or concurrent therapy requirements that fail to conform to generally accepted psychiatric practice and appear to have no actual clinical benefit.
Further, these new protocols may place a disproportionate burden on outpatient mental health clinics that treat Medicaid beneficiaries with chronic mental illness. Prior approval protocols such as these expend valuable clinical time and resources, taking time away from patient care and resulting in reduced access to necessary services. This is at a time when, due to increased regulation of controlled substances and a documented reluctance among primary care physicians to prescribe benzodiazepines, more and more patients with chronic mental illness including anxiety related symptoms are seeking care at mental health clinics, only further burdening an already over-burdened system of care.
These new restrictions on benzodiazepine therapy come close on the heels of New York’s I-STOP program, which went into effect on August 27, 2013 and requires that physicians consult an online database to review a patient’s controlled substance prescribing history prior to writing new prescriptions for Schedule II, III or IV controlled medications. To the extent that the DURB recommendations in question were intended to address concerns regarding overutilization of benzodiazepines, it seems clear that the State has already taken steps to address the problem of abuse and diversion of controlled substances. NYSPA strongly supports efforts to reduce doctor shopping and illegal diversion of controlled medications, including an additional DURB protocol that requires prescriber involvement in connection with concurrent opioid and benzodiazepine prescriptions. However, where a prescriber has already consulted the I-STOP registry to confirm that diversion or misuse is not a concern and the use of other opioids is not contemplated, the proposed step therapy and concurrent therapy protocols represent unnecessary additional restrictions on the prescription of essential psychiatric medications.
NYSPA has already written to the DURB and the Department of Health to express its concerns regarding these new restrictions and the need for prescriber involvement, which will likely cause a significant delay in patient access to necessary medications. These proposals clearly subject Medicaid patients to an inferior standard of care and NYSPA strongly supports a stay in implementation pending further review and input from the provider community.