Good News Forecast on Part D Drug Formularies

Patients with mental illness and substance abuse disorders—and advocacy groups that have been anxiously awaiting the rollout of the Medicare Part D prescription drug program—should expect generous formulary plans for antipsychotic and antidepressant drugs and few problems with appeals and requests for exceptions.

That was the consoling message delivered last month by Jeffrey Kelman, M.M.Sc., M.D., chief medical officer at the Center for Beneficiary Choices of the federal Centers for Medicare and Medicaid Services (CMS). He spoke at APA's 57th Institute on Psychiatric Services in San Diego.

In a remarkably upbeat presentation, Kelman emphasized repeatedly that CMS was encouraged by the breadth and depth of plan formularies, predicted few problems with appeals and requests for exceptions, and stressed the role that APA had played in securing coverage for patients with mental illness, including substance abuse.

Also encouraging was Kelman's statement that naltrexone and buprenorphine would be included in plan formularies. “Buprenorphine and naltrexone are certainly Part D drugs,” he said.

That had been by no means certain in August, when APA President Steven Sharfstein, M.D., wrote to CMS Administrator Mark McClellan, M.D., M.P.H., about concerns that drugs to treat alcohol and opioid dependence would not be included in the formularies of prescription drug plans (PDPs) or would be subject to such cost-containment measures as prior authorization or step, or“ fail-first,” therapy (Psychiatric News, October 7, 2005).

Prior to Kelman's remarks, CMS had assured mental health advocacy groups that “all or substantially all” of the drugs in six classes (antidepressants, antipsychotics, anticonvulsants, antineoplastics, immunosuppressants, and HIV drugs) would be on the formularies.

Nonetheless, APA and other groups have been working feverishly to anticipate a host of potential problems ranging from enrollment, to formulary restrictions and prior authorization or step-therapy requirements, to potential problems with copayments and continuity of care at the point of transition. They have especially focused on “dual eligibles”—those individuals who qualify for both Medicare and Medicaid—some 2.5 million of whom have mental illness.

That group is especially critical because their coverage for prescription drugs under the Medicaid plan will end when the new Medicare program begins on January 1, 2006 (Psychiatric News, October 7).

Kelman's remarks offered the first substantive hope that the worst fears, at least with regard to formulary restriction, would be averted.

“I have to say APA's leadership in this has been critical,” Kelman said. “The formularies are much more robust than we had expected, and no class of disease or drug is discriminated against. In the vast majority of cases, the PDP formularies are superior to state Medicaid formularies.”

Moreover, Kelman said that psychiatrists should expect minimal problems with processing appeals and requests for exceptions to the formularies. He noted that the population requiring antipsychotic drugs, for example, would be a small part of most PDPs' business and that the expensive and time-consuming process of appeals would make it unlikely that they would put up much resistance.

“I don't think any plan sees itself standing or falling on withholding antipsychotic drugs,” Kelman said. “I think we will see very reasonable responses to reasonable requests for exceptions. I'm not sure it's worth their while to fight with you.

“If a drug is deemed medically necessary by a provider for mental illness, we are expecting current regimens to be continued at current dosages,” Kelman said. “We are not expecting the plans to turn down drugs based on dosages.”

Kelman addressed psychiatrists at the meeting on October 8, when APA's Office of Healthcare Systems and Financing was just beginning to evaluate plan formularies. At press time, Irvin Muszynski, J.D., the office's director, told Psychiatric News that a preliminary appraisal of three national plans—Aetna, Medco, and the AARP plan—indicate that they cover the relevant psychiatric and substance abuse medications (including buprenorphine, methadone, acamprosate, disulfiram, and naltrexone) with few significant restrictions.

“I certainly hope our review of the formularies confirms [Kelman's] outlook,” Muszynski said.

But in a separate session at the IPS summarizing the new benefit, Muszynski cautioned that problems with transitioning patients into the new program—especially around determining whether PDP formularies match patient needs—could prove daunting and laborious.

He offered a schematic diagram for how clinicians may proceed at each point in the process of evaluating drug plans and with changes or appeals where necessary. The diagram and other similar decision-making tools are now available at<www.mentalhealthpartd.org> for advocates, clinicians, and patients. The site is sponsored by APA, the National Alliance for Mental Illness, and the National Mental Health Association

Throughout the IPS session, however, Kelman sought to dispel fears.“ Having looked at the formularies, I am impressed by their breadth and depth,” he said. “I am expecting minimal disruption in practice and a smooth transition.”

For some 8 million low-income Americans, the new benefit will be a landmark. “The end result we are anticipating is a new drug plan for a group of people who don't take drugs because they can't afford them.”▪