APA Marshals Resources To Fight Formulary Proposal

Psychiatric News reports on page 24 about APA's extensive, detailed comments on the federal government's draft rules to implement the Medicare Modernization Act (MMA), the law that establishes a new Medicare prescription drug benefit. APA members wishing to read or download our comments will find them posted online at<www.psych.org/advocacy_policy/reg_comments/cms-4086.pdf>.

The rules implementing the Medicare drug benefit could have a profound impact on our patients, particularly very vulnerable, low-income beneficiaries (so-called “dual eligibles”) who receive drug coverage through state Medicaid programs but will be shifted into the new Medicare benefit. Chief among our many concerns is that the proposed guidelines that participating health plans will have to follow for developing their respective formularies overly restrict access to psychotropic medications.

I hope you will take the time to read APA's extensive comments. They lay out in a clear and compelling way what we as psychiatrists know intuitively—that our patients need access to the full range of available medications and therapies to ensure that they receive state-of-the-art treatment. Nearly 40 percent of dual eligibles, for example, have cognitive or mental impairments; thus, the consequences of abrupt medication switching (or discontinuation) could be dire. Fortunately, most state Medicaid programs recognize the problem. Of the 40 states that have established preferred drug lists or formularies, 30 have included exemptions for psychiatric medications.

Without changes, these are among the likely consequences of the currently envisioned MMA rules:

As a result of our concern for the well-being of our patients, we are calling for the establishment of an alternative formulary—one that is the least restrictive possible. This alternative formulary would be for a class of enrollees who have a primary diagnosis as defined by DSM-IV-TR and for whom a physician has determined that it is medically necessary to treat their medical condition pharmacologically. This formulary would provide access to the full array of psychiatric medications for individuals with mental illness diagnoses, including dual-eligible beneficiaries, without such restrictive policies as fail first, prior authorization, step therapy, and therapeutic substitution.

As comprehensive as our comments are, they are one endpoint in a tremendous internal and external APA effort that is often hidden from the view of most members. The foundation for the case for an alternative formulary was created by the National Alliance for the Mentally Ill working in concert with APA's Department of Government Relations (DGR) and others, in report language adopted when the law was enacted that acknowledged the urgent need for attention to our patients. The comments themselves represent the outstanding work of the Office of Healthcare Systems and Financing and DGR.

It is not sufficient to argue policy in such comments. To have maximum impact, the comments have to make the case based on the law's intent. Here, Sam Muszynski, Andy Whitman, Becky Yowell, and other staff members have done a great job in making the scientific, medical, and legal case for our proposed alternative formulary.

That is only the tip of the current effort. APA has long been working in a coalition with patient groups and others concerned about the impact of the law. We have held meetings with key officials from the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services to preview our concerns. We have presented testimony to the group responsible for recommending technical details about how a formulary would work. Our government relations staff have arranged for meetings with key House and Senate committee staff (both Republicans and Democrats) to ensure that Congress understands the consequences of a poorly thought-out drug benefit for our patients. Working behind the scenes, DGR staff helped ensure that key members of Congress asked tough questions of officials responsible for implementing the law. And you—our members—responded magnificently to our request that you send your own supporting comments directly to CMS.

When I joined APA as your medical director, I assigned a high priority to getting our dedicated staff to work better together. It is human nature in any bureaucracy (and APA is a bureaucracy, too) to focus on the pressing priorities confronting your own “silo.” Our division and department directors are working to break down their silos to ensure that APA is responding effectively to urgent priorities by utilizing the expertise of our entire organization. The team-oriented approach to the MMA and other issues, such as our coordinated response to the struggle to ensure continued access to antidepressants for children and adolescents, is yielding important dividends to APA, our members, and—more importantly—our patients.

Please send your comments to me at [email protected].▪