Concern over new CMS proposed rule on Six Protected Classes

By Nathaniel Counts, MHA Senior Policy Director

Yesterday, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule on Medicare Advantage and Part D Drug Pricing. While Mental Health America (MHA) supports CMS’s overall goal of lower health care costs for individuals, MHA is concerned about the effect the policy could have on access to medications for individuals with mental health and substance use conditions.

Current policy requires insurers offering Medicare Part D plans, which covers outpatient prescription drugs, to include on their formularies all or substantially all drugs in six medication classes. These are referred to as “The Six Protected Classes,” and include antidepressants and antipsychotics. The Six Protected Classes were put in place as acknowledgment that, for some conditions, individuals respond differently to different medications and formulations, and that individuals need access to a full range of options in achieving wellness. For example, each person responds differently to each antidepressant, and if people only had access to one or two antidepressants, they might not have access to an option that works for them and might get sicker as a result. By having the Six Protected Classes in place, those with Medicare are more likely to be able to access the medications they need for their mental health conditions at reasonable costs.

Yesterday’s CMS proposed rule would create new exceptions to The Six Protected Classes policy to allow insurers to institute new prior authorization or step therapy requirements or exclude medications entirely under some circumstances. MHA is concerned that limitations on medication access driven by cost (rather than any compelling clinical reason), will hurt individuals with mental health and substance use conditions in the short-term, and actually increase health care spending in the long-term. In the coming days, MHA will be analyzing the proposed rule and responding, and encourages other advocates to do so as well.