Why the Six Protected Classes Should Be Protected

Susan Weinstein, JD
Editor in Chief, Care for Your Mind

The Trump Administration has proposed a new rule that would change Medicare Part D, removing the requirement that Part D prescription plans cover “all or substantially all” medications in six “protected” classes: anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals, and immunosuppressants. Why does this matter to us?

Medicare Part D Primer

Broadly speaking, Medicare, which provides health care coverage for people age 65 and older, does not include prescription drug coverage for self-administered medications (i.e., those for which a patient purchases at retail and does not need to be at a medical office or facility when taking the medication (swallowing, inhaling, injecting, etc.)). Medicare Part D is the optional prescription drug coverage program, made available through commercial insurers (not the government). In addition to premiums, Medicare Part D members pay the cost of their prescriptions until they meet their deductible, then pay a co-insurance share up to an annual limit. Even with these payments and with prescription drugs sorted into tiers of different prices, enrollees tend to save money on their prescription medications.

One reason is that the companies that offer Part D plans usually rely on pharmacy benefit managers (PBMs) to negotiate with the pharmaceutical companies on the price of medications. Because Medicare does not require Part D plans to offer coverage for all prescriptions, only at least two medications from the most commonly-prescribed category and class of medications for medical conditions, PBMs can choose among different drugs and offer coverage for only those that have favorable pricing. But that doesn’t apply for the six protected classes. Instead, for those classes of medications, as noted above, the Part D plans must include all or substantially all medications, including both generic and brand name drugs.

Why does this matter to us?

As you can see, the proposed rule (click to download the 185-page document) would mean that the Part D plans would only need to include a much smaller variety of prescription drugs on its formulary (covered medications). Many in the Care for Your Mind community have experience with prescription drugs for depression, so they are personally aware that not every medication is effective for every person and not every medication affects every person in the same way. To not have access to appropriate medications, even those that have been effective if they are not on the formulary, can be the difference between life and death for a person with depression.

So why does it matter to us, particularly those of us who are not Medicare beneficiaries?

One, for humanitarian reasons. The proposed changes target vulnerable people, including the elderly, people affected by more than one chronic condition, and people who are among the most ill in the nation. They need to have access to the medications that work for them, as prescribed by their healthcare provider.

Two, because when patients, families, and healthcare providers engage in shared decision making, the treatment chosen best fits the patient’s priorities and preferences and is most likely to be maintained. A solid decision relies on having access to the treatment that will work for them.

Three, not all people respond to medication in the same way. Harder-to-treat cases need access to a variety of medications. Those medications should not be available only to those with financial resources or to those who endure trials with ineffective medications to satisfy prerequisites for the more expensive medications.

Four, even if this were a cost-saving measure, the negative health and cost consequences will outweigh likely savings. People who do not get the right medication not only don’t get well, they often get sicker and their emergency department visits and hospital admissions increase. Studies show, too, that the existing controls on the protected drug classes result in significantly greater use of generic medications than brand name drugs.

Care for Your Mind was created to inform readers about how health care policies and practices affect access to and quality of mental health care with the aim of equipping members of our community to be educated advocates in mental health care reform. We’re concerned that these proposed changes to the Protected Classes would negatively impact access to medication necessary for people with depression, schizophrenia, and psychosis to get well and maintain their quality of life.

The good news is that we – the mental health community – are not the only advocates concerned about reducing protections for these six classes of medications. Patient advocacy groups for those with cancer, HIV/AIDS, Parkinson’s disease, epilepsy, lupus, organ transplants, and more have joined in opposition to the proposed rule.

Next week’s post comes from the leading coalition working to protect access to the medications we need to be well. After you read it, you’ll know the important talking points as well as how to submit your comments prior to the January 25th deadline.


What do you think?

  • Many people describe the challenges of getting the prescriptions they need to get well. What’s your experience? Tell us on Facebook!

Additional Resources

On Care for Your Mind

(We’ve faced a similar proposed rule in the past; the posts are still relevant. You can also click on the Medicare category for related posts.)

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