Potential Changes to Medicare Part D Concerning Protected Classes has the Potential to Negatively Impact Cancer Care

February 21, 2019


In November, the Centers for Medicare & Medicaid Services (CMS) proposed a new rule that would allow for several changes to the protected classes policy in Medicare Part D. The Cancer Support Community is concerned that if these changes are allowed, patients may face barriers to the cancer treatments that are right for them.  

What is Medicare Part D and what are the Protected Classes?

Medicare Part D is a voluntary outpatient prescription drug benefit, which allows people in the Medicare program to gain access to affordable prescription drug coverage. These benefits are provided through private health insurance plans and approved by the federal government. Participants are able to choose between supplementing their traditional Medicare with a stand-alone prescription drug plan (PPD) or a Medicare Advantage prescription drug plan, which is a part of and includes other aspects of Medicare. To learn more about the two ways to get Medicare prescription drug coverage as well as how to join a drug plan, you can find more information here.

Within Medicare there are six “protected classes” for prescription drugs. They include:

  1. Antidepressants
  2. Antipsychotics
  3. Anticonvulsants
  4. Immunosuppressants (for treatment of transplant rejection)
  5. Antiretrovirals (for the management of HIV/AIDS)
  6. Antineoplastics (used in chemotherapy to kill cancer cells)

Currently all Part D plans are required to cover all the drugs that fall into these protected classes, which includes cancer medications and mental health medications. Essentially, these classes were created and actively function as safeguards for vulnerable populations, in an attempt to protect chronically ill patients who may require high cost therapies from discriminatory practices that negatively impact their health outcomes.

How Would the Rule Change This?

The proposed rule would allow for three major changes to the current protected classes policy. These include:

  1. Implement broader use of prior authorization and step therapy for protected class drugs, including to determine use for protected class indications
    • Prior authorization is a requirement in which your physician needs to get approval from your health insurance before they are able to prescribe a specific medication for you.
    • Step therapy is process in which health insurance plans require you to begin a medication that is the most cost-effective and prove that it is ineffective before moving up to a costlier therapy.
  2. Exclude a protected class drug from a formulary if the drug represents only a new formulation of an existing single-source drug or biological product, regardless of whether the older formulation remains on the market
  3. Exclude a protected class drug from a formulary if the price of the drug increased beyond a certain threshold over a specified look-back period

In short, the proposal largely gives plans more flexibility to limit the coverage options within the protected classes in an effort to lower drug costs. However, this lowering of drug costs would save money primarily for the health care system, and less for individual patients.     

What Does This Mean for Patients?

Many cancer patients have prescriptions covered by Medicare Part D that fall within the protected classes, so what affect does this proposed rule have? If coverage is limited, it could have serious consequences for cancer patients covered by Medicare.

Excluding new, updated formularies from coverage within the protected classes hinders access to care for cancer patients. Therapies are often designed to target very specific conditions and may have no therapeutic equivalent. In other words, there may only be one therapeutic option for patients and exclusion of unique cancer therapies could force many cancer patients to lose access to the most appropriate therapy.

Prescription drugs are a vital part of cancer care and interrupting timely access to them poses significant consequences to cancer patients. If patients are not provided with the opportunity to select the most clinically appropriate therapies, they may experience delays in appropriate care, poorer physical and psychosocial health outcomes, and increased out-of-pocketing spending.

What Can You Do?

There are many ways that you can get active in the effort to protect coverage within the protected classes. The most important thing you can do is to share your story! Take to your social media and share why access to medication through the protected classes is important to your health. You can also share your story with us through our Share Your Story tool, and sign up for the Grassroots Network to receive timely updates on threats to your access to care.