Medicare to Drop Antidepressants as Part D “Protected Class”

Starting in 2015, psychiatrists will have to juggle antidepressant selections for Medicare patients. The Center for Medicare and Medicaid Services (CMS) has proposed dropping antidepressants as one of the 6 categories of pharmaceuticals for which Medicare Part D drug plans must provide “all or substantially all” of the products available. That means Part D formularies can reduce the number of antidepressants they offer to 2, which is the case for all classes except the 6. Each Part D plan has a different formulary, meaning that individual Medicare patients will have access to different antidepressants. In addition, the CMS wants to drop antipsychotics in the future but will keep that class protected in 2015 while it considers potential “transition steps” to make the elimination of the class easier for patients.

The elimination of antidepressants, immunosuppressants, and eventually antipsychotics has not gone well with physicians, patients, or drug companies. “We have supported the protected classes since the inception of the Part D program in 2006 and have regarded it as a key policy to effect the nondiscrimination mandates of the law,” said Irvin Muszynski, Director of the Office of Healthcare Systems and Financing of the American Psychiatric Association.

Antidepressants, antipsychotics, anticonvulsants, antineoplastics, antiretrovirals, and immunosuppressants are the 6 drug categories the CMS designated as “protected classes” back in 2005 just before the Medicare Part D drug program was established. (Part D plans are combinations put together by health plans and pharmacy-benefit managers.) The health plans and pharmacy-benefit managers hated the protected-classes policy from the beginning. They argued the policy led to higher drug costs for Medicare because they were unable to negotiate rebates with drug manufacturers. A number of independent studies bore out that contention, including one from the Inspector General at the Department of Health and Human Services in March 2011. But drug manufacturers and patient groups fought to keep the policy intact.

In the proposed rule published on January 10, 2014, the CMS conceded: “. . . the circumstances that existed when this policy was originally implemented have changed dramatically in the more than 7 years the program has been in operation.” These circumstances were recognized by Congress and were included in the Affordable Care Act. One of the requirements, however, was that the CMS review the protected-classes policy and identify “classes of clinical concern.” The CMS came up with 2 criteria for determining which classes qualified:

• Hospitalization, persistent or significant disability or incapacity, or death likely will result if initial administration (including self-administration) of a drug in the category or class does not occur within 7 days of the date the prescription for the drug was presented to the pharmacy to be filled

• More specific CMS formulary requirements will not suffice to meet the universe of clinical drug- and disease-specific applications because of the diversity of disease or condition manifestations and associated specificity or variability of drug therapies necessary to treat such manifestations

The agency put together a consensus panel of CMS pharmacists and its Chief Medical Officer to identify which drug categories or classes met the proposed criteria for clinical concern. The consensus panel determined that of the current 6 protected drug categories, 3 (anticonvulsants, antineoplastics, and antiretrovirals) met both of the proposed criteria, and 3 did not (antidepressants, antipsychotics, and immunosuppressants).

Antidepressants met neither of the criteria. Antipsychotics met the first criterion but not the second. However, in the case of antipsychotics, the CMS explained that it wants to make certain it has not overlooked a need for any transitional considerations. “This is because the risks associated with untreated psychotic illness, as differentiated from the broad category of mental illness, have the potential to be so severe.”

Andrew Sperling, Director, Legislative Advocacy, the National Alliance on Mental Illness (NAMI), explained his group is very unhappy with the proposed rule. The NAMI is particularly concerned with the 9 million Medicare enrollees who are severely disabled; many receive disability payments because of schizophrenia or bipolar disease. The CMS proposed rule appears to allow Part D plans to impose the maximum of 2 drugs per category only on “new starts,” that is, individuals new to a plan in 2015, or in 2016 in the case of antipsychotics. Sperling believes that because the severely disabled are automatically and frequently switched between subsidized plans, many of them may qualify as “new starts” in 2015 and 2016 and thereby may be denied antidepressants and/or antipsychotics they have been taking for years given the previous “all or substantially all” categorization their earlier plan was subject to.