Mental Health America Calls Changes to Part D Protected Drug Classes Harmful to Consumers;Will Join with Advocacy Groups in Opposing Rule | Mental Health America

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Mental Health America Calls Changes to Part D Protected Drug Classes Harmful to Consumers;Will Join with Advocacy Groups in Opposing Rule


ALEXANDRIA, Va. (January 9, 2014)—Mental Health America said today a new rule proposed by the Centers for Medicare and Medicaid Services (CMS) to remove anti-depressants and antipsychotics from its “protected” status on Part D drug plan formularies would be harmful to consumers.

The proposed rule revises long-standing prior agency policy that required Part D plans to include on their formularies “all or substantially all” drugs within six classes: anti-depressants, antipsychotics, anticonvulsants, antineoplastics, and immunosuppressants. This policy, known as the “six protected classes” policy, has been in effect since the inception of Part D, and has strong congressional support.

David L. Shern, Ph.D, president and CEO of Mental Health America, said the organization is a strong supporter of six classes policy and would join with other advocacy groups in submitting comments opposing the rule, which are due by March 7.

“For many mental health consumers, access to the full range of the most effective medications is a crucial component of successful treatment and recovery,” he said. “Such medically necessary psychotropic medications, and their combination with other services and supports, are often essential to permit people with mental health and substance use conditions to recover and to lead healthy and productive lives in their communities. “

Dr. Shern said policies that restrict access to medically necessary medication not only fail to achieve their intended purpose of reducing overall health care costs but prolong human suffering, and reduce the potential for an individual with a mental health or substance use condition to achieve full recovery.

“These policies fail to acknowledge that physicians and consumers should make individualized treatment decisions, recognizing the unique and non-interchangeable nature of human beings and psychotropic medications, and acknowledging that lack of access to medications has both human and fiscal consequences,” he said.

Although drug costs are not part of the formal criteria, CMS indicated that Part D plans' inability to negotiate protected class drug prices was a main reason it proposed to remove anti-depressants and immunosupressants from the protected class status they received under Medicare Part D in 2015, and to remove antipsychotics from that status in 2016.

Mental Health America (, founded in 1909, is the nation’s leading community-based network dedicated to helping all Americans achieve wellness by living mentally healthier lives. With our 240 affiliates across the country, we touch the lives of millions—Advocating for changes in mental health and wellness policy; Educating the public & providing critical information; and Delivering urgently needed mental health and wellness Programs and Services.


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